Food Safety in the 111th Congress:
H.R. 2749 and S. 510
Renée Johnson, Coordinator
Specialist in Agricultural Policy
Sarah A. Lister
Specialist in Public Health and Epidemiology
Erin D. Williams
Specialist in Public Health and Bioethics
Vanessa K. Burrows
Legislative Attorney
Harold F. Upton
Analyst in Natural Resources Policy
Jim Monke
Specialist in Agricultural Policy
December 1, 2010
Congressional Research Service
7-5700
www.crs.gov
R40443
CRS Report for Congress
P
repared for Members and Committees of Congress
Food Safety in the 111th Congress: H.R. 2749 and S. 510
Summary
American consumers spend more than $1 trillion on food each year. The combined efforts of the
food industry and government regulatory agencies often are credited with making the U.S. food
supply among the safest in the world. Nonetheless, public health officials have estimated that
each year in the United States, many millions of people become sick and thousands die from
foodborne illnesses caused by any of a number of microbial pathogens and other contaminants. At
issue is whether food safety agencies have the resources, authority, and structural organization to
safeguard the public, and whether they use resources effectively. Also at issue is whether federal
food safety laws, first enacted in the early 1900s, have kept pace with the significant changes in
the food production, processing, and marketing sectors since then.
In the 111th Congress, comprehensive food safety legislation passed both the House (H.R. 2749)
in July 2009 and the Senate (S. 510) in November 2010. Both the House and Senate bills mainly
focus on the U.S. Food and Drug Administration’s (FDA’s) food regulation rather than that of the
U.S. Department of Agriculture (USDA), which oversees most meat and poultry. The bills would
generally expand or modify existing FDA authorities rather than create a new food safety
structure or authorities.
Future congressional action, however, remains uncertain. Following passage of the Senate-passed
bill, it was reported that the House might block the Senate bill using a procedure known as “blue-
slipping,” because the bill contains fees that might be subject to certain tax origination provisions.
Food safety legislation is a response to a number of perceived problems with the current food
safety system. For example, a growing consensus is that the FDA’s current programs are not
proactively designed to emphasize prevention, evaluate hazards, and focus inspection resources
on areas of greatest risk to public health. Given its widely acknowledged funding and staffing
constraints, and no explicit requirement on the frequency of inspections, the agency infrequently
visits food manufacturing and other facilities to check sanitary and other conditions. Both the
House and Senate bills (in different ways) would require food processing, manufacturing,
shipping, and other regulated facilities to conduct an analysis of the most likely safety hazards
and to design and implement risk-based controls to prevent them. The bills envision
establishment of science-based “performance standards” for the most significant food
contaminants. To help determine such risks and hazards, the bills propose improvement of
foodborne illness surveillance systems.
Both bills seek to increase frequency of inspections, tighten record-keeping requirements, extend
more oversight to certain farms, and mandate product recalls if a firm fails to institute them
voluntarily. Major portions of the bills are devoted to increasing the scrutiny of food imports,
which account for a growing share of U.S. consumption; food import shipments would have to be
accompanied by documentation that they can meet safety standards that are at least equivalent to
U.S. standards. Such certifications might be provided by foreign governments or other so-called
third parties accredited in advance. The House and Senate bills differ in how to accomplish these
objectives. The bills have provisions for certifying or accrediting laboratories, including private
laboratories, to conduct sampling and testing of food.
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Food Safety in the 111th Congress: H.R. 2749 and S. 510
Contents
Introduction ................................................................................................................................ 1
Food Safety Incidents............................................................................................................ 2
Existing Food Safety Legal and Regulatory Landscape.......................................................... 3
Administration Views............................................................................................................ 5
Congressional Response........................................................................................................ 6
Legislative Overview ...................................................................................................... 7
Overview of Major Provisions......................................................................................... 8
Selected Issues .......................................................................................................................... 11
Registration ........................................................................................................................ 11
Record-Keeping.................................................................................................................. 12
Hazard Analysis and Risk-Based Preventive Controls.......................................................... 13
Performance Standards........................................................................................................ 15
On-Farm Safety Standards; Safety of Produce ..................................................................... 16
Mitigating Effects on Small Business and Farming Operations ............................................ 18
Targeting of Inspections ...................................................................................................... 26
Use of Third Parties for Imports and for Laboratory Accreditation....................................... 29
Mandatory Recall Authority ................................................................................................ 31
Notification of Contaminated Products and Product Tracing................................................ 32
Foodborne Illness Surveillance and Outbreak Response ...................................................... 34
Criminal Penalties............................................................................................................... 36
Food Imports ...................................................................................................................... 39
Bisphenol A (BPA).............................................................................................................. 41
Paying for Food Safety with User Fees................................................................................ 42
Tables
Table 1. Crosswalk of Food Safety Provisions ........................................................................... 10
Table 2. U.S. Farms and Food Manufacturers, 2007................................................................... 20
Table 3. FDA Food-Related Inspection Data, FY2004-FY2011.................................................. 27
Table 4. Criminal Penalties for Violations of FFDCA § 303(a)................................................... 37
Table 5. FDA Direct Appropriations for Foods, FY2005-FY2011 .............................................. 43
Table 6. Fees in the House-Passed Bill (H.R. 2749) and the Senate-Passed Bill (S. 510) ............ 45
Table 7. Comparison of Annual Fees in the House-Passed Bill (H.R. 2749) and the
Senate-Passed Bill (S. 510) .................................................................................................... 46
Table 8. Comparison of Periodic Fees in the House-Passed Bill (H.R. 2749) and the
Senate-Passed Bill (S. 510) .................................................................................................... 47
Appendixes
Appendix A. Snapshot of Provisions in the House-Passed Bill (H.R. 2749) and the
Senate-Passed Bill (S. 510), Ranked by Section Number ........................................................ 49
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Food Safety in the 111th Congress: H.R. 2749 and S. 510
Appendix B. Comparison of Current Law with Provisions in the House-Passed Bill (H.R.
2749) and the Senate-Passed Bill (S. 510) .............................................................................. 52
Contacts
Author Contact Information .................................................................................................... 100
Acknowledgments .................................................................................................................. 100
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Food Safety in the 111th Congress: H.R. 2749 and S. 510
Introduction
The combined efforts of the food industry and government regulatory agencies often are credited
with making the U.S. food supply among the safest in the world. Nonetheless, public health
officials have estimated that each year in the United States, many millions of people become sick
and thousands die from foodborne illnesses caused by any of a number of microbial pathogens
and other contaminants.1 At issue is whether the current food safety system has the resources,
authority, and structural organization to safeguard the health of American consumers, who spend
more than $1 trillion on food each year.2 Also at issue is whether federal food safety laws, first
enacted in the early 1900s, have kept pace with the significant changes that have occurred in the
food production, processing, and marketing sectors since then.
In 2007 and again in 2009, the Government Accountability Office (GAO) placed food safety on
its biennially published list of high risk areas, one of 30 needing concerted attention by Congress
and the Administration.3 GAO has identified 15 federal agencies collectively administering at
least 30 laws related to food safety. The majority of both total funding and total staffing, however,
is with the Food Safety and Inspection Service (FSIS) at the U.S. Department of Agriculture
(USDA), which regulates most meat and poultry, and the Food and Drug Administration (FDA) at
the U.S. Department of Health and Human Services (HHS), which regulates virtually all other
foods. FSIS’s annual budget in FY2010 was approximately $1.1 billion in appropriated funds plus
an estimated $131 million in industry-paid user fees. FDA’s annual budget for its human foods
program was $784 million for FY2010, all of it appropriated.4
This CRS report discusses several recent food safety incidents and the systemic food safety
problems that they illustrate. It also describes the existing food safety legal and regulatory
landscape and presents an overview of efforts by the 111th Congress to revise federal food safety
authorities and activities, principally at FDA. The two bills discussed are those that have passed
in the House—H.R. 2749, the Food Safety Enhancement Act of 2009—and in the Senate—S.
510, the FDA Food Safety Modernization Act. This report also presents a number of selected food
safety issues, describing how they are addressed in current law and regulation, and comparing
their treatment in each of the bills. Finally, appendixes provide a crosswalk of all provisions in
H.R. 2749 and S. 510, followed by a side-by-side comparison of all of these provisions with each
other and with current law.
1 According to the U.S. Department of Health and Human Services, Centers for Disease Control and Prevention, 76
million people become sick, 325,000 are hospitalized, and 5,000 die from foodborne illnesses each year (“Foodborne
Illness: Frequently Asked Questions,” accessed at http://www.cdc.gov/foodsafety/). However, this estimate appears to
be based primarily on 1997 and earlier data in a report by Paul S. Mead et al., “Food-related Illness and Death in the
United States,” Emerging Infectious Diseases, vol. 5, pp. 607-625, 1999.
2 Nearly half of U.S. food spending is now in restaurants and other places outside the home. Roughly two-thirds of the
$1 trillion is for domestically produced farm foods; imports and seafood account for the balance. Data source: U.S.
Department of Agriculture (USDA), Economic Research Service.
3 GAO, High Risk Series: An Update (GAO-09-271), January 2009.
4 Source: USDA and HHS budget materials for FY2011. The FDA figure does not include some food safety activities
carried out by the Center for Veterinary Medicine and National Center for Toxicological Research. For more
information on current food safety authorities and agencies, with sources, see CRS Report RS22600, The Federal Food
Safety System: A Primer. Also see CRS Report R40721, Agriculture and Related Agencies: FY2010 Appropriations.
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Food Safety Incidents5
Food safety-related incidents frequently heighten public and media scrutiny of the U.S. food
safety system.6 Large recalls of FSIS-regulated meat and poultry products due to findings of E.
coli O157:H7, Listeria, and other problems occur each year.7 In addition, in recent years, several
large multi-state outbreaks have been linked to FDA-regulated foods. For example, in 2006 more
than 200 confirmed illnesses and three deaths were linked to bagged fresh spinach grown in
California and contaminated with E. coli O157:H7. In 2008, more than 1,400 persons were
infected with the same unusual strain of bacteria, Salmonella Saintpaul. Officials first suspected
fresh tomatoes, but later tests found the pathogen in serrano peppers and irrigation water from a
farm in Mexico. These incidents raised public concerns about the safety of all fresh produce and
stimulated a number of industry and government initiatives to limit future incidents.
Attention focused on the safety of food imports in 2007, when pet food ingredients imported from
China, contaminated with the chemical melamine, sickened or killed an unknown number of dogs
and cats and contaminated some livestock feeds. In 2008, melamine contamination of infant
formula in China sickened thousands of children and raised concerns about the safety of infant
formula in the United States. The melamine incidents highlighted the limited reach of FDA’s
oversight of imports, the difficulty in tracing the many pathways taken by a common food
ingredient, and the frequent confluence of human and animal food ingredients.
In late 2008 and early 2009, a multi-state outbreak of Salmonella Typhimurium was linked to an
institutional brand of peanut butter and other peanut-based ingredients from a single firm. The
outbreak sickened more than 700 people in 46 states, and may have contributed to the deaths of
nine people. A series of expanding recalls was announced by FDA in early 2009, involving
thousands of peanut-containing products from more than 200 companies. Again, the incident
highlighted the broad reach of a common contaminated ingredient, and the resultant challenges in
rapidly tracing products and removing them from commerce.
In July 2010, health officials noticed a spike in cases of infection with Salmonella Enteritidis, a
strain commonly associated with shell eggs, which are regulated by FDA.8 In August, FDA found
the same pathogen on two egg farms in Iowa, leading to the nationwide recall by the companies
of more than 500 million eggs.9 In July 2009, FDA had published a long-awaited egg safety
regulation, which became effective in July 2010 as the outbreak was well underway.10 Although
most observers believe that the rule, if enforced, will help to prevent shell egg contamination and
outbreaks in the future, many remain concerned with the apparent lack of coordination between
USDA’s egg quality inspection activities and FDA’s food safety activities.11
5 Unless otherwise cited, material in this paragraph is adapted from CRS Report R40916, Food Safety: Foodborne
Illness and Selected Recalls of FDA-Regulated Foods.
6 Three recent multi-state foodborne outbreaks and their implications for the nation’s food safety system are discussed
in more depth in CRS Report R40916, Food Safety: Foodborne Illness and Selected Recalls of FDA-Regulated Foods.
7 For information on meat and poultry recalls, see the FSIS website: http://www.fsis.usda.gov/fsis_recalls/index.asp.
8 USDA regulates processed egg products, and grades shell eggs for quality (such as grade and size), but does not
oversee the safety of shell eggs.
9 FDA, “Salmonella Enteritidis Outbreak in Shell Eggs,” http://www.fda.gov/Food/NewsEvents/WhatsNewinFood/
ucm222684.htm.
10 FDA, “Prevention of Salmonella Enteritidis in Shell Eggs During Production, Storage, and Transportation; Final
Rule,” 74 Federal Register 33029, July 9, 2009. See also FDA, “Egg Safety Final Rule,” http://www.fda.gov/Food/
FoodSafety/Product-SpecificInformation/EggSafety/EggSafetyActionPlan/ucm170615.htm.
11 Alicia Mundy, Bill Tomson, “Egg Inspectors Failed to Raise Alarms,” The Wall Street Journal, September 10, 2010.
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Existing Food Safety Legal and Regulatory Landscape
Federal responsibility for food safety rests primarily with FDA and USDA.12 FDA is responsible
for ensuring that all domestic and imported food products—except for most meats and poultry—
are safe, nutritious, wholesome, and accurately labeled. FDA also has oversight of all seafood,
fish, and shellfish products. USDA’s FSIS regulates most meat and poultry and some egg
products. State and local food safety authorities collaborate with federal agencies for inspection
and other food safety functions, and they regulate retail food establishments.
The division of food safety responsibility between FDA and USDA is rooted in the early history
of U.S. food regulation. Congress created separate statutory frameworks when it enacted, in 1906,
both the Pure Food and Drugs Act and the Meat Inspection Act. The former addressed the
widespread marketing of intentionally adulterated foods, and its implementation was assigned to
USDA’s Bureau of Chemistry. The latter law addressed unsafe and unsanitary conditions in meat
packing plants, and implementation was assigned to the USDA’s Bureau of Animal Industry. This
bifurcated system has been perpetuated and split further into additional food safety activities
under additional agencies (for example, the Environmental Protection Agency, the National
Marine Fisheries Service, and others) by a succession of statutes and executive directives. The
separation of the two major food safety agencies was further reinforced when, in 1940, the
President moved responsibilities for safe foods and drugs, other than meat and poultry, from
USDA to the progenitor of HHS, the Federal Security Agency. Meat inspection remained in
USDA. There has been discussion over time regarding whether this dispersal of food safety
responsibilities has been problematic, or whether a reorganization would divert time and attention
from other fundamental problems in the system.13
Major food safety bills that have passed both in the House (H.R. 2749) and in the Senate (S. 510),
which are the subject of this report, do not propose a major reorganization of food safety
agencies. Rather, they focus on changes related to FDA, not USDA. The primary law authorizing
FDA activities is the Federal Food, Drug, and Cosmetic Act (FFDCA; 21 U.S.C. §§ 301 et seq.).
Some key FFDCA provisions that are discussed throughout this report are presented in the text
box on the next page.
Two of the basic statutory components from the FFDCA are “adulteration” and “misbranding.”
FDA-regulated foods may be deemed adulterated or misbranded for a variety of statutorily
prescribed reasons. For example, food may be deemed adulterated if it contains an added
poisonous or deleterious substance or an unsafe food additive or if the food was prepared, packed,
or held under insanitary conditions whereby it may have become contaminated or may have been
rendered injurious to health. Persons who violate the FFDCA by, for example, introducing an
adulterated or misbranded product into interstate commerce, commit what is referred to as a
prohibited act under FFDCA § 301 (21 U.S.C. § 331). Persons who commit prohibited acts are
subject to criminal and civil penalties.
12 For further background information about the food safety system, see CRS Report RS22600, The Federal Food
Safety System: A Primer. For further information about FDA’s regulatory authority, see CRS Report RS22946, Food
and Drug Administration (FDA): Overview and Issues.
13 For a discussion of the history of federal food safety organization and of efforts to change it, see Merrill, Richard A.
and Jeffrey K. Francer, “Organizing Federal Food Safety Regulation,” Seton Hall Law Review, vol. 31:61, 2000. See
also GAO, High Risk Series: An Update (GAO-07-310), January 31, 2007; and Ensuring Safe Food From Production
to Consumption, Committee to Ensure Safe Food from Production to Consumption, Institute of Medicine, National
Research Council, National Academy Press, 1998.
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Key Definitions and Authorities in the Federal Food, Drug, and Cosmetic Act (FFDCA)
Food: FFDCA § 201(f) [21 U.S.C. § 321(f)] defines food as “(1) articles used for food or drink for man or other animals, (2) chewing
gum, and (3) articles used for components of any such article.” Unless a provision in law regarding food limits its applicability to one or
the other, it would apply equal y to both human foods, and to animal foods and feeds.
Raw Agricultural Commodity: FFDCA § 201(r) [21 U.S.C. § 321(r)] defines the term raw agricultural commodity to mean “any
food in its raw or natural state, including all fruits that are washed, colored, or otherwise treated in their unpeeled natural form prior to
marketing.” This may also refer to an unprocessed human food or animal feed crop, including fresh fruits and vegetables, grains, or
other crops and products.
Adulteration: Under the FFDCA, introducing adulterated food into commerce, adulterating food that is in commerce, or the
receipt and delivery of adulterated food in commerce, is prohibited (FFDCA § 402(a) [21 U.S.C. § 342(a)]).
A food shall be deemed to be adulterated—(1) If it bears or contains any poisonous or deleterious substance which may render it injurious
to health; but in case the substance is not an added substance such food shall not be considered adulterated under this clause if the quantity
of such substance in such food does not ordinarily render it injurious to health; [or](2)(A) if it bears or contains any added poisonous or
added deleterious substance (other than a substance that is a pesticide chemical residue in or on a raw agricultural commodity or processed
food, a food additive, a color additive, or a new animal drug) that is unsafe within the meaning of § 406; or (B) if it bears or contains a
pesticide chemical residue that is unsafe within the meaning of § 408(a); or (C) if it is or if it bears or contains (i) any food additive that is
unsafe within the meaning of § 409; or (i ) a new animal drug (or conversion product thereof) that is unsafe within the meaning of § 512; or
(3) if it consists in whole or in part of any filthy, putrid, or decomposed substance, or if it is otherwise unfit for food; or (4) if it has been
prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been
rendered injurious to health; or (5) if it is, in whole or in part, the product of a diseased animal or of an animal which has died otherwise
than by slaughter; or (6) if its container is composed, in whole or in part, of any poisonous or deleterious substance which may render the
contents injurious to health; or (7) if it has been intentionally subjected to radiation, unless the use of the radiation was in conformity with a
regulation or exemption in effect pursuant to § 409.
Misbranding: Under the FFDCA, introducing misbranded food into commerce, misbranding food that is in commerce, or the
receipt and delivery of misbranded food in commerce is prohibited. (See “Prohibited Acts” below.) FFDCA § 403 [21 U.S.C. §
343] defines a number of conditions under which a food would be deemed to be misbranded, beginning with a broad provision in
paragraph (a) saying that a food is deemed misbranded if its label “is false or misleading in any particular ...” Similar to the definition
of adulteration, numerous specific types of misbranding are also defined. These include, among others, failure to disclose specific
additives or allergens in the food, and failure to provide required nutritional information.
Person: FFDCA § 201(e) [21 U.S.C. § 321(e)] defines person to include an individual, partnership, corporation, and association. In
this report, for simplicity, facility is often used to refer to actions that may or must be taken with respect to a facility, though it is,
of course, a person, typically the owner, operator or agent in charge of the facility, who may or must act.
Facility: FFDCA § 415(b) [21 U.S.C. § 350d(b)] defines a food facility as “any factory, warehouse, or establishment (including a factory,
warehouse, or establishment of an importer) that manufactures, processes, packs, or holds food. Such term does not include farms;
restaurants; other retail food establishments; nonprofit food establishments in which food is prepared for or served directly to the consumer;
or fishing vessels (except such vessels engaged in processing as defined in [21 C.F.R. 123.3(k)]).”
Retail Food Establishment: Defined in 21 C.F.R. 1.227(b)(11) as “an establishment that sel s food products directly to consumers
as its primary function.” Such establishments may include restaurants, grocery stores, convenience stores, vending machine
locations, and establishments that manufacture/process, pack, or hold food as their primary function (if the annual monetary value
of sales of food products directly to consumers exceeds the annual monetary value of sales of food products to al other buyers).
Prohibited Acts: Prohibited acts are listed in FFDCA § 301 [21 U.S.C. § 331]. Along with other specified prohibited acts in
FFDCA § 301, paragraphs (a) through (c) provide that introducing adulterated or misbranded food into commerce; adulterating
or misbranding food that is in commerce; or the receipt and delivery of adulterated or misbranded food in commerce is
prohibited. Pursuant to FFDCA § 303 [21 U.S.C. § 333], in general, any person who violates a provision of FFDCA § 301 may be
subject to civil or criminal penalties, including imprisonment, fines, or both. Criminal penalties provided for in the FFDCA are
adjusted by 18 U.S.C. §§ 3559 and 3571. Certain exceptions may be made, including for the misbranding of foods.
Source: Prepared by CRS based on the FFDCA. A version of the FFDCA is available on FDA’s website at http://www.fda.gov/
RegulatoryInformation/Legislation/FederalFoodDrugandCosmeticActFDCAct/default.htm. It does not reflect two recent laws. P.L.
111-31, the Family Smoking Prevention and Tobacco Control Act, redesignated Chapter IX (miscel aneous provisions) as Chapter
X, and inserted tobacco control provisions in Chapter IX. P.L. 111-148, the Patient Protection and Affordable Care Act, amended
several FFDCA sections and added a new § 1011, establishing an FDA Office of Women’s Health.
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Administration Views
The George W. Bush Administration issued several reports and studies calling for major changes
in the food safety system. Two Bush Administration initiatives were unveiled in November 2007
and were critiqued and debated extensively during the 110th Congress. They were the FDA’s Food
Protection Plan: An Integrated Strategy for Protecting the Nation’s Food Supply, and the
Interagency Working Group on Import Safety’s Action Plan for Import Safety: A Roadmap for
Continual Improvement, part of which dealt extensively with food product imports.14 Both reports
generally called for a more preventive risk-based approach to food safety oversight, including
more attention to imported foods, among numerous other recommendations.
President Barack Obama, in a March 14, 2009, weekly radio address, called the food safety
system a “hazard to public health.”15 He announced a Food Safety Working Group (FSWG) of
Cabinet secretaries and senior officials “to advise me on how we can upgrade our food safety
laws for the 21st century; foster coordination throughout government; and ensure that we are not
just designing laws that will keep the American people safe, but enforcing them.”16 In July 2009,
the FSWG announced a number of steps the Obama Administration was taking, under existing
authorities, to improve government safeguards.17 The group released a one-year progress report in
July 2010.18 Also, the Administration announced that it had “taken steps to reduce the prevalence
of E. coli, implemented new standards to reduce exposure to Campylobacter, and issued a rule to
control Salmonella contamination,” and that “FDA has conducted a pilot study on a tracing
system, and HHS, in collaboration with USDA, has rolled out an enhanced and updated
www.foodsafety.gov site to provide consumers rapid access to information on food recalls.”19
The Obama Administration has weighed in on the principal bills that have been considered by the
House and Senate during the 111th Congress (and that are the subject of this report). The
Administration declared its support for H.R. 2749, which had passed in the House.20 Also, in a
July 2010 statement, the Administration urged the Senate to complete its work on S. 510.21 In
November 2010, the Administration expressed its continued support of the Senate’s efforts on its
bill.22 In addition, Administration officials have testified on aspects of the legislation. Testimony
14 FDA, “An Integrated Strategy for Protecting the Nation’s Food Supply,” November 2007, http://www.fda.gov/Food/
FoodSafety/FoodSafetyPrograms/FoodProtectionPlan2007/ucm132565.htm; and the Interagency Working Group on
Import Safety, “Action Plan for Import Safety: A Roadmap for Continual Improvement,” November 2007,
http://archive.hhs.gov/importsafety/report/actionplan.pdf.
15 The White House, Remarks of President Barack Obama, “Reversing a Troubling Trend in Food Safety,” weekly
address, Washington, DC, March 14, 2009, http://www.whitehouse.gov/briefing-room/weekly-address.
16 The working group established a public website at http://foodsafetyworkinggroup.gov/, where the full text of these
remarks may be viewed.
17 FSWG, “Food Safety Working Group: Key Findings,” July 7, 2009, http://www.foodsafetyworkinggroup.gov/.
18 FSWG, “Food Safety Working Group: Progress at 1 Year,” July 9, 2010, http://www.foodsafetyworkinggroup.gov/.
19 The White House, Statement by the President on Food Safety, July 7, 2010, http://www.whitehouse.gov/the-press-
office/statement-president-food-safety.
20 The White House, Statement by the President on House Passage of the Food Safety Enhancement Act of 2009, July
30, 2009, http://www.whitehouse.gov/the-press-office/statement-president-house-passage-food-safety-enhancement-
act-2009.
21 The White House, Statement by the President on Food Safety, July 7, 2010, http://www.whitehouse.gov/the-press-
office/statement-president-food-safety.
22 The White House, Statement of Administration Policy, “S. 510—The FDA Food Safety Modernization Act,”
November 16, 2010, http://www.whitehouse.gov/sites/default/files/omb/legislative/sap/111/saps510s_20101116.pdf.
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regarding specific provisions of the House bill was given by FDA Commissioner Dr. Margaret
Hamburg to the House Energy and Commerce Subcommittee on Health on June 3, 2009, and by
FDA Senior Advisor Michael R. Taylor to the House Agriculture Committee on July 16, 2009.23
In October 2009 testimony on the Senate bill, FDA Commissioner Hamburg called S. 510 a
“major step in the right direction.” Provisions in the bill address a key policy concern by
refocusing FDA’s food safety system on prevention, the Commissioner stated. She added that the
bill also generally meets another key policy concern, the need for adequate FDA legal tools to
implement the new requirements, although some additional provisions, such as effective
enforcement mechanisms, should be added. Finally, the Commissioner stated, the legislation must
provide or anticipate adequate resources, but it “does not provide a guaranteed consistent funding
source to help FDA fulfill its new responsibilities.” The Commissioner recommended the
inclusion of registration fees, flexibility to adjust facility inspection frequencies, and use of
accredited third parties to ensure adequate resources.24 (These issues are among those discussed
later in this report.)
Congressional Response
These and other developments have made food safety a top issue for many lawmakers. Some
Members of Congress have called for major changes in the U.S. food safety system and/or
funding increases that they assert are needed to meet current obligations to protect consumers
from unsafe food. Perceived gaps in federal safeguards have been explored at more than two
dozen congressional hearings since 2007.25 The 110th Congress made several amendments to
FDA’s food safety authorities,26 and increased funding for the primary food safety agencies, but
more comprehensive food safety legislation was not enacted.
In the House, U.S. food safety laws variously fall under the purview of the Energy and
Commerce Committee, which claims jurisdiction over all FDA-regulated products, including
foods, and the Agriculture Committee, which claims the lead on USDA’s meat and poultry
inspection programs. Similarly, in the Senate, the Committee on Health, Education, Labor, and
Pensions (HELP) has jurisdiction over FDA-regulated foods and other products, while the
Agriculture Committee has jurisdiction over USDA inspection programs. In contrast with the split
in jurisdictions among the authorizing committees, within each of the House and Senate
Appropriations Committees, one subcommittee (Agriculture) is responsible for funding and
oversight of both FDA and USDA.
23 Dr. Hamburg’s comments were based on the introduced version of H.R. 2749; Mr. Taylor’s were based on the
version reported by the full Energy and Commerce Committee (H.Rept. 111-234) in June 2009.
24 Statement of FDA Commissioner Margaret Hamburg, U.S. Congress, Senate Committee on Health, Education,
Labor, and Pensions, Keeping America’s Families Safe: Reforming the Food Safety System, 111th Cong., 1st sess.,
October 22, 2009, http://help.senate.gov/hearings/index.cfm.
25 This includes hearings conducted by the House and Senate Agriculture Committees; House Committee on Energy
and Commerce; Senate Committee on Health, Education, Labor, and Pensions (HELP); House Committee on Small
Business; House Committee on Oversight and Government Reform; House Committee on Homeland Security; House
Committee on Ways and Means; Senate Appropriations Committee; and Senate Committee on Commerce, Science,
and Transportation.
26 CRS Report RS22779, Food Safety: Provisions in the Food and Drug Administration Amendments Act of 2007.
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Legislative Overview
In the 111th Congress, nearly a dozen food safety bills, several of them comprehensive, were
introduced. The major vehicle in the House is H.R. 2749, introduced by Representative John
Dingell. This bill was amended and approved by the Subcommittee on Health of the House
Energy and Commerce Committee on June 10, 2009; and by the full committee on June 17, 2009
(H.Rept. 111-234, July 29, 2009). After failing to reach the needed two-thirds majority under
suspension of the rules on July 29, 2009, the bill passed the House under regular order, with a
recorded vote of 283 to 142, on July 30, 2009.27
In the Senate, S. 510 was introduced by Senator Richard Durbin. The HELP Committee amended
and reported the bill (without a written report) on December 18, 2009. During the spring and
summer of 2010, Senators discussed potential amendments to S. 510, aimed at addressing issues
of continued interest. In August 2010, several members of the HELP Committee, including
Chairman Senator Tom Harkin and Ranking Member Senator Mike Enzi, along with Senator
Durbin, released a “manager’s package,” an amendment to S. 510 in the nature of a substitute.28
Following the release of the proposed manager’s amendment, Senate floor action was widely
anticipated. However, further action on the measure stalled. Among other things, Senator Tom
Coburn objected to the projected cost of the measure.29 Also, amendments to the Senate
manager’s proposal were being considered, including a proposal by Senators Jon Tester and Kay
Hagan to exempt certain small facilities from the proposed requirements under some
circumstances. These and other proposed amendments are discussed in this report.
In November 2010, the Senate resumed consideration of its bill. A second substitute amendment
to S. 510 (S.Amdt. 4715) was offered30 and included modified provisions proposed by Senators
Tester and Hagan, among other changes. This substitute amendment to S. 510 passed the Senate
on November 30, 2010, with a recorded vote of 73-25. Among other prepared amendments, two
amendments offered by Senator Coburn—one banning earmarks for three years and another
substituting S. 510 with a separate food safety proposal—did not pass the Senate.
Following passage of the Senate bill, however, it was reported that the House may block the
Senate bill using a procedure known as “blue-slipping,” because the bill contains fees that might
be subject to certain tax origination provisions.31 In addition, Representative Dingell has
expressed reservations about the Senate-passed bill’s lack of industry fees and about added
provisions under the Tester-Hagan amendment.32
27 Two other comprehensive House bills were introduced by Representative Rosa DeLauro (H.R. 875) and by
Representative Jim Costa (H.R. 1332).
28 U.S. Senate Committee on Health, Education, Labor, and Pensions, “Senate Leaders Release Manager’s Package of
the FDA Food Safety Modernization Act,” press release, August 12, 2010, http://help.senate.gov/newsroom/press/.
29 Senator Tom Coburn, Unanimous Consent Request, S. 510, Congressional Record, daily edition, vol. 156
(September 23, 2010), pp. S7394-S7397.
30 Senator Tom Harkin, “Proposed Amendment, S. 510,” Congressional Record, November 18, 2010, pp. S8069-
S8093.
31 John Stanton, “House May Block Food Safety Bill Over Senate Error,” Roll Call, November 30, 2010. For more
information on blue-slipping, see CRS Report RS21236, Blue-Slipping: The Origination Clause in the House of
Representatives, and CRS Report RL31399, The Origination Clause of the U.S. Constitution: Interpretation and
Enforcement.
32 Ellyn Ferguson, "Senate’s Food-Safety Bill Might Need Some Work, Dingell Says," CQ Today Online News,
November 30, 2010.
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Overview of Major Provisions
Both the House- and Senate-passed bills focus primarily on FDA-regulated foods, and would
achieve their proposed reforms through the agency’s existing structure and authorities, in
particular the Federal Food, Drug, and Cosmetic Act (FFDCA; 21 U.S.C. §§ 301 et seq.).
Although differing somewhat in approach, both bills seek to address many of the same perceived
problems with the current food safety system. For example, a growing consensus among industry
and consumer groups is that the FDA’s current programs are not proactively designed to
emphasize prevention, evaluate hazards, and focus inspection resources on areas of greatest risk
to public health.33 Rather, FDA generally has been reactive, usually stepping in when adulterated
or misbranded products are found in commerce or an illness outbreak leads them to a problem.
Given FDA’s funding and staffing constraints, and no explicit requirement for the frequency of
inspections, the agency infrequently visits food manufacturing and other facilities to check
sanitary and other conditions.34
Both the House and Senate bills would require (although in different ways) food processing,
manufacturing, shipping, and other regulated facilities to conduct an analysis of the most likely
food safety hazards and to design and implement risk-based controls to prevent them. These
proposals are similar conceptually to the so-called hazard analysis and critical control point, or
HACCP, plans required of meat and poultry establishments. The bills envision the establishment
of science-based “performance standards” for the most significant food contaminants. To aid in
determining such risks and hazards, both bills propose the improvement of foodborne illness
surveillance systems aimed at better data reporting, analysis, and usefulness, with the CDC
playing a lead role.
Both bills seek to increase the frequency of plant inspections, taking into account the risks posed
by specific foods or processes. To aid in such inspections, and to improve the ability to rapidly
trace food products through the production and marketing chain in the event of a foodborne
illness outbreak, suspected contamination, or other problems, the bills generally seek to
strengthen record-keeping requirements and food traceability systems. Industry participants
would be required to maintain records for certain time periods and in formats to be prescribed by
FDA. The importance of adequate records has been demonstrated in recent food safety incidents,
particularly in the case of outbreaks eventually linked to fresh produce. Food establishments,
which are already subject to a one-time registration requirement under the Public Health Security
and Bioterrorism Preparedness and Response Act of 2002 (P.L. 107-188; 21 U.S.C. § 350d),
would have to re-register more frequently under the bills, which ask for additional registration
information. Also, the House-passed bill would require a $500-per-facility annual registration fee.
The bills also appear to agree on the need to give FDA the authority to mandate product recalls if
a firm with suspect products fails to do so voluntarily. Currently FDA lacks such authority for
food, except for infant formula. However, the measures differ somewhat on how such authority
might be applied, and on related requirements for notification when adulterated or misbranded
food threatens public health.
33 See, for example, Jerry Hagstrom, “Array of Groups Push Senate Action on Food Safety Bill,” CongressDailyAM,
September 21, 2010.
34 See, for example, FDA, “Strategic Priorities 2011–2015: Responding to the Public Health Challenges of the 21st
Century,” draft, September 29, 2010, pp. 14-15, http://www.fda.gov/AboutFDA/ReportsManualsForms/
Reports/ucm227527.htm.
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Both bills contain extensive provisions for heightened scrutiny of imports, which have comprised
an increasing share of U.S. food consumption. Food import shipments might newly have to be
accompanied by documentation that they are from facilities and establishments certified as
meeting safety standards at least equivalent to U.S. standards. Such certifications might be
provided by foreign governments or other so-called third parties accredited in advance by an
accrediting body recognized by FDA; again, the House and Senate bills differ in detail on how to
accomplish these objectives. They also address the need for certifying or accrediting laboratories,
including private laboratories, to conduct sampling and testing of food.
Provisions in the bills seek, in differing ways, to extend safeguards to the farm level, generally
calling for new, science-based regulations for safe production mainly of fruits, vegetables, and
related products, and expanding enforcement and record-keeping authorities.
A key difference between the two bills is how the proposed program changes would be funded.
Specifically, the House-passed bill would institute a new $500 annual facility registration fee that
would help offset the cost of various FDA activities in the bill; a similar annual facility fee is not
included in the Senate-passed bill, and other fees included in the Senate bill are not expected to
raise as much revenue. The Congressional Budget Office (CBO) estimates that implementing
H.R. 2749 (as reported by the Energy and Commerce Committee) would increase net federal
spending subject to appropriation by about $2.0 billion over a five-year period (FY2010-
FY2014); federal revenues from civil penalties for food-related violations under the FFDCA
would increase by $10 million over the same period.35 CBO estimates that spending under S. 510
(reflecting the August 2010 Senate amendment) would increase net federal spending subject to
appropriation by about $1.4 billion over a five-year period (FY2011-FY2015); collections from
possible revenue and direct spending increases from new criminal penalties would be
“insignificant, yielding a negligible net impact in each year.”36 Despite higher offsetting fee
revenues proposed in the House bill, CBO scored higher net federal costs for the House bill than
for the Senate bill due to higher costs in the House bill for FDA activities (principally related to
facility inspections) that would not be supported by fees.
Another key difference between the two bills is the Senate bill’s addition of provisions that would
exempt certain food processing operations from the proposed HACCP requirements and also
would exempt certain farms from the new produce standards. Under the Senate-passed bill, farms
and food facilities that would qualify for an exemption are those businesses with an “average
annual monetary value” of all food sold during the previous three-year period of less than
$500,000, provided that the food is sold directly to “qualified end users” such as consumers,
restaurants, or retail food establishments located in the same state where the facility sold the food
or within 275 miles of the facility, among other requirements. In addition, although both the
House and Senate bills clarify the types of businesses that should be considered to be “retail food
establishments” and therefore generally not subject to the facility registration requirements, the
Senate bill specifies that roadside stands, farmers’ markets, and foods sold through a community-
supported agriculture (CSA) program would also not be subject to the requirements. Additional
information on these provisions is provided later in this report.
35 CBO, Cost Estimate, “H.R. 2749, Food Safety Enhancement Act of 2009 as ordered reported by the House
Committee on Energy and Commerce on June 17, 2009,” July 24, 2009.
36 CBO, Cost Estimate, “S. 510, Food Safety Modernization Act, as reported by the Senate Committee on Health,
Education, Labor, and Pensions on December 18, 2009, incorporating a manager’s amendment released on August 12,
2010,” August 12, 2010.
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Neither the House-passed nor the Senate-passed bill encompasses a major reorganization of food
safety agencies. Both measures have provisions (§ 4 and § 403, respectively) to ensure that the
jurisdiction between FDA and USDA would not be altered.37
Table 1 provides a crosswalk of topics covered in this report and corresponding section numbers
from the two major proposals. This table does not contain all of the topics or sections in the two
proposals, only those included in the body of this report.
Table 1. Crosswalk of Food Safety Provisions
(House-passed H.R. 2749 and Senate-passed S. 510, by topic)
Topic
H.R. 2794 (House-passed)
S. 510 (Senate-passed)
Registration 101
102
Record-Keeping 106 101
Hazard Analysis and Risk-Based
102 103,
114
Preventive Controls
Performance Standards
103
104
On-Farm Safety Standards; Safety
104 105
of Produce
Mitigating Effects on Small
101, 102, 104, 106, 107, 112
101, 102, 103, 105, 201, 204
Business and Farming Operations
Targeting of Inspections
105, 207
201, 306
Use of Third Parties for Imports
109, 110
202 , 303
and for Laboratory Accreditation
Mandatory Recal Authority
102, 105, 108, 111, 204
206
Notification of Contaminated
107, 112
204, 211
Products and Product Tracing
Foodborne Illness Surveillance and
121 205
Outbreak Response
Criminal Penalties
134
None
Food Imports
109, 113, 136, 204, 205, 206
301, 302, 303
Bisphenol A (BPA)
215
None
Paying for Food Safety with User
101, 108, 203, 204
107, 401
Fees
Source: Prepared by CRS based on the text of the House-passed and Senate-passed bills (H.R. 2749 and S. 510).
Note: Terms in the “Topic” column are hyperlinked to corresponding sections in this report.
For a comprehensive listing of all sections and topics addressed in the two bills, see the two
appendix tables at the end of this report. The first table, Appendix A, provides a snapshot of each
section and topic covered by the proposals. It is arranged numerically by section of H.R. 2749,
and then by those remaining sections of S. 510 that have no corollary in the House bill.
37 Past debates have examined proposals to combine all federal food safety agencies and authorities under a single,
possibly Cabinet-level, agency. For example, a bill introduced by Representative DeLauro bill (H.R. 875) proposed to
transfer FDA’s food safety activities to a new food safety agency within HHS, creating a Food Safety Administration
with an Administrator appointed to a five-year term by the President and confirmed by the Senate.
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The second table, Appendix B, contains a side-by-side comparison of current law with provisions
in the two proposals. Appendix B is arranged in the same order as Appendix A, so the latter can
be used as a table of contents for the former. Topics in Appendix B are hyperlinked to
corresponding sections of this report where they exist, so that readers can easily move from the
side-by-side to related policy context and analysis.
Selected Issues
The following sections provide a discussion of the key provisions in H.R. 2749 and S. 510, as
passed by their respective chambers. Unless otherwise noted, references to “the Secretary” mean
the HHS Secretary.
Registration
Keeping Track of Food Facilities
The FFDCA already requires domestic and foreign food facilities to register with FDA, pursuant
to provisions in P.L. 107-188, the Bioterrorism Act (FFDCA § 415; 21 U.S.C. § 350d). Excepted
are farms, restaurants, retailers, and certain types of nonprofit food establishments and fishing
vessels. Renewal is not required on any periodic basis, but registrants must notify the HHS
Secretary in a timely manner of relevant changes in their status. The FFDCA (§ 801(l); 21 U.S.C.
§ 381(l)) provides that imported food may not be delivered to the importer, owner, or consignee
of the article unless the foreign facility is registered. FDA does not have explicit authority to
require a registration fee from domestic or foreign facilities.
Some assert that registration requirements should be strengthened so that authorities will be
notified when a firm moves, undertakes a new food business, or changes product lines.
Otherwise, FDA’s records of facilities that are manufacturing and marketing food are continually
out of date, it is argued. Others have argued that additional registration requirements would be
needlessly intrusive and costly for industry.
Legislative Proposals
The House-passed bill (§ 101) would require annual registration, and would deem foods from
unregistered facilities to be misbranded, which therefore would prohibit such food from being
introduced into, or delivered or received in, commerce. The bill would amend FFDCA § 415 to
clarify (but not change) the types of facilities that would remain exempt from the registration
requirement, explicitly defining “retail food establishment” and “farm.” It also would spell out
additional types of information to be required of registrants. The bill also would provide
procedures for the suspension of registration for “a violation of [the FFDCA] that could result in
serious adverse health consequences or death to humans or animals,” and procedures for vacating
such a suspension. Registration fees would be imposed (discussed later in this report).
The Senate-passed bill (§ 102) would require domestic and foreign facilities to register every two
years, and to provide some additional types of contact information, with an abbreviated renewal
process available to facilities with no change in status. The bill would provide procedures for the
suspension of registration if the HHS Secretary “determines that food manufactured, processed,
packed, received, or held by a facility registered under this section has a reasonable probability of
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causing serious adverse health consequences or death to humans or animals.” It also would
provide procedures, somewhat different from those in the House-passed bill, for vacating such a
suspension. Facilities with suspended registrations would be barred from importing or introducing
food into commerce. Importing or introducing such food into commerce would be prohibited, and
subject to possible civil and criminal penalties and other enforcement actions. The bill would not
change the current exemptions from the registration requirement for farms, restaurants, retailers,
and certain types of nonprofit food establishments and fishing vessels. It also would not impose
registration fees.
Both the House and Senate provisions clarify the types of facilities that would be included as a
“retail food establishment”38 and therefore generally would not be subject to the requirements.
The Senate-passed bill would require the HHS Secretary to amend the definition of “retail food
establishment” to include food sold directly to consumers by a roadside stand or farmers’ market,
food sold through a community supported agriculture (CSA) program, or sale and distribution of
food at any other such direct sales platform as determined by the Secretary (§ 102(c)). The
House-passed bill specifies that a “retail food establishment” would include an establishment that,
as its primary function, “sells food products (including those food products that it manufactures,
processes, packs, or holds) directly to consumers (including by Internet or mail order),” and also
would include grocery stores, convenience stores, vending machine locations, and stores that sell
bagged feed, pet food, and feed ingredients or additives over the counter directly to consumers
and final purchasers for their own personal animals.
Record-Keeping
Should Documentation Requirements and Access to Records Be Strengthened?
Pursuant to provisions in P.L. 107-188, the Bioterrorism Act (FFDCA § 414; 21 U.S.C. § 350c),
the FFDCA authorizes the HHS Secretary to impose record-keeping requirements on domestic
and foreign food facilities (except farms and restaurants), and to inspect and copy such records
“[i]f the Secretary has a reasonable belief that an article of food is adulterated and presents a
threat of serious adverse health consequences or death to humans or animals.” The Secretary must
take appropriate measures to ensure that unauthorized disclosure of any trade secret or
confidential information is prevented. Through rulemaking, the Secretary has required facilities to
maintain records that allow for the identification of the immediate previous sources and
immediate subsequent recipients of food.39
Advocates of food safety reform often argue that record-keeping requirements must be
strengthened to help regulators determine whether firms are complying with the law, and to
facilitate outbreak investigations and product recalls. Among their concerns is that records do not
have to be maintained in electronic format, which, these advocates assert, delays outbreak
response. Related concerns include the types and level of detail of records to be kept, how long
they should be retained, and access to and use of these records by authorities. For example, is the
current “trigger” for accessing records (quoted above) too stringent to assure food safety, too
permissive to protect industry interests, or appropriately balanced between the two? Concerns
38 21 C.F.R. 1.227(b)(11).
39 FDA, “Establishment and Maintenance of Records Under the Public Health Security and Bioterrorism Preparedness
and Response Act of 2002,” 69 Federal Register 71561, December 9, 2004. Facilities are required to retain records for
specified periods of time, up to a maximum of two years, depending on the type of food.
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about increased record-keeping requirements and access authority often involve concerns about
the intrusiveness of government, as well as about privacy and the protection of sensitive
commercial information (trade secrets), for example.
Legislative Proposals
The House-passed bill (§ 106) would expand the Secretary’s authority to inspect and copy
relevant records of a food facility in order to determine whether a food is adulterated or
misbranded, by removing the requirement that the Secretary have “a reasonable belief that an
article of food is adulterated and presents a threat of serious adverse health consequences or death
to humans or animals.” Removing this requirement would authorize access to records during
routine inspections. The bill also would remove the requirement to provide written notice before
having such access, and would authorize the Secretary to require that records be kept for up to
three years and be maintained in a standardized electronic format. Farms would generally remain
exempt from the requirement to provide access to records unless the Secretary determined, with
respect to specified commodities, that such commodities posed a risk to public or animal health,
or were the subject of an active investigation of a foodborne illness outbreak. Restaurants would
be required to provide access to records, but would only have to keep records regarding their
suppliers and any subsequent distribution other than to consumers.
The Senate-passed bill (§ 101) would expand the Secretary’s authority to inspect and copy
relevant records of a food facility in two ways, but would not appear to authorize access during
routine inspections, as would the House-passed bill. The bill would require that access be
provided to the HHS Secretary if he or she “has a reasonable belief that an article of food, and
any other article of food that the Secretary reasonably believes is likely to be affected in a similar
manner, is adulterated and presents a threat of serious adverse health consequences or death to
humans or animals,” or if the Secretary “believes that there is a reasonable probability that the use
of or exposure to an article of food, and any other article of food that the Secretary reasonably
believes is likely to be affected in a similar manner, will cause serious adverse health
consequences or death to humans or animals.” The Secretary would have greater flexibility under
the second provision, no longer having to have a reasonable belief that food is adulterated in
order to access records. The Secretary also would be allowed access to records regarding foods
likely to be affected in a similar manner, but would need to believe there is at least a risk of harm.
Unlike the House bill, farms and restaurants would (as under current law) be fully exempt from
this provision. For other facilities, written notification would still be required to gain access.
(See the subsequent section on “Notification of Contaminated Products and Product Tracing.”)
Hazard Analysis and Risk-Based Preventive Controls
Reactive vs. Preventive Intervention
A broad consensus of policymakers agrees that FDA’s system of food safety safeguards should be
more proactive in addressing the nation’s complex food supply.40 By and large, the agency’s
statute and regulations spell out the reasons a food article is to be considered adulterated or
40 Emily Ethridge, “Food Safety Bill Advances,” CQ Markup and Vote Coverage, Senate Health, Education, Labor and
Pensions Committee Markup of S. 510, November 18, 2009.
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misbranded and therefore unfit for consumption. In effect, industry players are expected to abide
by the rules; generally it is only when a problem is detected—often after an illness outbreak is
reported or testing finds a contaminant in a product—that officials step in to correct it, or order
the industry to do so.
A recurring theme now in discussions of food safety modernization is prevention. Virtually all
stakeholders, including regulators, the regulated industries, consumer advocates, and food safety
scientists agree that the foundations of any new program should be an understanding of what, and
how, hazards can enter the food supply, followed by implementation of measures to prevent these
hazards.41 A popular version of this approach is the so-called HACCP system, which many private
companies already use, and which was incorporated in the 1990s by FSIS as a regulatory
requirement for all meat and poultry slaughtering and processing establishments.42 Variations of
the HACCP system also are required by FDA in the processing of seafood, juices, and low-acid
canned foods, but not other product categories.
Committees of the National Academy of Sciences’ National Research Council (NAS-NRC) have,
in a number of reports, recommended the HACCP approach for food safety. For example, its
Committee on the Review of the Use of Scientific Criteria and Performance Standards for Safe
Food stated at the outset of a 2003 report:
The balance of progress in reduction of certain human foodborne illnesses following
implementation of [HACCP] in various areas of the food industry is decidedly favorable.... The
committee believes that the emphasis of food safety regulatory agencies must continue to be on
prevention, reduction, or elimination of foodborne hazards along the food continuum.43
The National Advisory Committee on Microbiological Criteria for Foods, established to offer
ongoing advice to the FDA and USDA, agreed with the NAS-NRC recommendations, which have
dated at least to the early 1990s. The advisory committee also noted that HACCP principles
should be standardized to provide uniformity in training and applicability, but also must be
developed by each food establishment so they can be tailored to individual products, processing,
and distribution conditions.44
Legislative Proposals
The House and Senate bills (§ 102 and § 103, respectively) contain somewhat similar provisions
requiring each owner, operator, or agent of a facility to evaluate the hazards that could affect food
manufactured, processed, packed, transported, or held there; identify and implement preventive
41 Testimony of Margaret A. Hamburg, FDA Commissioner, before the U.S. Senate Committee on Health, Education,
Labor, and Pensions, October 22, 2009; Committee on the Review of the Use of Scientific Criteria and Performance
Standards for Safe Food, National Research Council, Scientific Criteria to Ensure Safe Food, National Academies
Press, 2003; Center for Science in the Public Interest (CSPI), “Building a Modern Food Safety System for FDA
Regulated Foods,” May 2009; Consumers Union, August 1, 2008, letter to the U.S. House of Representatives.
42 Savage, Robert A. and Daniel Lafontaine, “HACCP Principles: Benchmark for Food Safety,” Food Quality
magazine, February/March 2010, http://www.foodquality.com/. Also see CRS Report RL32922, Meat and Poultry
Inspection: Background and Selected Issues.
43 Committee on the Review of the Use of Scientific Criteria and Performance Standards for Safe Food, National
Research Council. Scientific Criteria to Ensure Safe Food, National Academies Press, 2003.
44 National Advisory Committee on Microbiological Criteria for Foods, Hazard Analysis and Critical Control Point
Principles and Application Guidelines, adopted August 14, 1997.
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controls to significantly minimize, prevent, or eliminate such hazards; and monitor and maintain
records on these controls once they are in place. The bills further specify types of hazards that
should be evaluated, and they require facilities to conduct a re-analysis at specified intervals, and
to maintain at least two years of records to document and verify their control measures, among
other details (which differ somewhat between the bills, with the House version appearing to be
somewhat more prescriptive). Written HACCP-type and/or broader written food safety plans
containing HACCP requirements are also elements of the bills. Under the House-passed bill,
higher-risk facilities must submit test results when finished products are found to contain
contaminants “posing a risk of severe adverse health consequences or death” (although there are
some limitations on the extent of the Secretary’s authority). The Senate-passed bill contains
requirements regarding available FDA guidance documents for seafood (see § 114 and § 103) that
are not in the House-passed bill.
In addition, the Senate bill would exempt some facilities from the requirements under certain
conditions, as discussed in more detail in the section titled “Mitigating Effects on Small Business
and Farming Operations.”
Performance Standards
Can Safety Be Better Measured?
Performance standards typically are specific, quantitative measurements of a property of, or a
substance in, food that are selected to serve as benchmarks for whether the food is safe in a
broader sense. For example, a microbial performance standard could be used to determine
whether a product is contaminated with microbes in general, and whether a problem with the
product’s processing should be investigated and corrected. The NAS-NRC standards committee
reported that a common theme of regulatory performance standards is “to provide clear
articulation of what is and is not acceptable in the process or system being regulated.”45 The
committee added that regulators like the FDA, USDA, and the Environmental Protection Agency
(EPA) have employed specific standards for diverse reasons and conditions and based on
numerous scientific, legal and practical constraints, including:
tolerances (which set legal limits) on the presence of chemicals in food, prohibitions on specific
microbial pathogens in specific foods, standards for process control, and standards defining the
acceptable outcome of a food process for reducing pathogenic contamination. All of these are
performance standards in the sense that they define what must be achieved in controlling risk
factors for food safety.46
The FFDCA does authorize FDA to promulgate standards for certain hazards, such as tolerances
for pesticide or drug residues in foods, but does not grant explicit authority to develop standards
solely as a means to verify that processing is done in a manner that ensures safe food.47
45 Committee on the Review of the Use of Scientific Criteria and Performance Standards for Safe Food, National
Research Council, Scientific Criteria to Ensure Safe Food, National Academies Press, 2003, p. 16.
46 Ibid, p. 17.
47 FSIS in 1996 had established two performance standards to verify the microbial safety of meat and poultry products
as part of its HACCP regulation. FSIS’s efforts to take enforcement action for violations of its standard upper limit for
Salmonella contamination were constrained by a successful legal challenge, but it still interprets noncompliant
Salmonella test results as a HACCP violation rather than a specific violation of the standard. For more information see
(continued...)
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Legislative Proposals
The House and Senate bills both include language on performance standards (§ 103 and § 104,
respectively). Although differing in detail, both bills would amend the FFDCA to require the HHS
Secretary to, at least every two years, review and evaluate epidemiological data, health data, or
other information to identify the most significant hazards and to issue guidance or regulations on
science-based performance standards to significantly minimize, prevent, or eliminate such
hazards. Such standards must be specific to products or product classes, not individual facilities.
The Senate provisions would place conditions on the issuance of standards, requiring them to be
“[b]ased on such review and evaluation, and when appropriate to reduce the risk of serious illness
or death to humans or animals or to prevent the adulteration of food” under the FFDCA. The
Senate bill further requires that this review and evaluation of “health data and other relevant
information” be conducted in coordination with USDA. The House-passed bill says such issuance
shall be “as soon as practicable” and “as appropriate, to minimize to an acceptable level, prevent,
or eliminate the occurrence of such hazards.”
On-Farm Safety Standards; Safety of Produce
Should Agricultural Producers Get More Scrutiny?
Food safety experts agree that an effective, comprehensive food safety system should include
consideration of potential hazards at the farm level. Viewpoints diverge on whether this should be
mandatory or voluntary. Should farmers and ranchers be subject to mandatory safety standards,
enforced through certification of their practices, periodic inspections, and penalties for
noncompliance? Or, should public policy continue to encourage voluntary strategies for
producing safe foods on farms and ranches, through education, cooperation, and market-based
incentives? Historically, the federal and state governments have largely relied on the latter
approach. In addition, numerous existing laws and regulations already impose restrictions, both
direct and indirect, on producers of food commodities; these restrictions involve compliance costs
and are intended to meet certain food safety objectives. They include requirements on the use of
animal drugs, feed additives, and pesticides.
FDA’s “current good manufacturing practice” (CGMP) requirements (at 21 C.F.R. Part 110) apply
to manufacturing, packing, or holding human food, but establishments engaged solely in
harvesting, storing, or distributing raw agricultural commodities generally are excluded.48 Farms
are among those exempted from a requirement that food facilities be registered with FDA,
pursuant to the Public Health Security and Bioterrorism Preparedness and Response Act of
2002.49 Further, the FFDCA specifically exempts farms (and restaurants) from requirements to
maintain records for up to two years for purposes of identifying “immediate previous sources and
the immediate subsequent recipients of food, including its packaging, in order to address credible
threats of serious adverse health consequences or death to humans or animals,” and to permit
(...continued)
CRS Report RL32922, Meat and Poultry Inspection: Background and Selected Issues.
48 21 C.F.R. 110.19(b). The FFDCA at 21 U.S.C. § 321(r) defines a “raw agricultural commodity” as “any food in its
raw or natural state, including all fruits that are washed, colored, or otherwise treated in their unpeeled natural form
prior to marketing.”
49 P.L. 107-188; 21 U.S.C. 350(d).
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officials access to these records if a food is suspected of being adulterated and presenting a
serious health threat.50
FDA’s general approach has been not to impose mandatory on-farm safety standards or
inspections of agricultural facilities.51 Rather, the agency tends to rely on farmers’ adoption of so-
called good agricultural practices to reduce hazards prior to harvest. Such practices are issued as
FDA guidance, not regulations.52 In July 2009, the Obama Administration released new draft
guidances on three specific types of produce: tomatoes, melons, and leafy greens.53 However,
FDA’s final rule (effective July 2010) requiring shell egg producers to implement on-farm safety
measures to prevent contamination of eggs by Salmonella Enteritidis (SE) is one example of FDA
regulatory activity on-farm.54
Legislative Proposals
Several provisions in the House- and Senate-passed bills could potentially affect agricultural
producers, including smaller farms and food processors, as well as organic, direct-to-market, and
sustainable farming operations. The provisions that could have the most direct effect on on-farm
activity, especially produce growers, would be the establishment of new standards for produce
safety (§ 104 and § 105, respectively).
The House-passed bill would require the Secretary, in consultation with the Secretary of
Agriculture, to publish a notice of proposed rulemaking, and within three years after such date,
final rules, establishing scientific and risk-based standards for the safe growing, harvesting,
processing, packing, sorting, transporting, and holding of those types of raw agricultural
commodities that are a fruit, vegetable, nut, or fungus, and for which the Secretary has
determined such standards are reasonably necessary to minimize the risk of serious adverse health
consequences or death to humans or animals. The House-passed bill states that these regulations
could set forth procedures and practices that the Secretary determines to be reasonable to prevent
50 21 U.S.C. 350c and 21 U.S.C. § 374. Dr. Andrew C. von Eschenbach, FDA Commissioner, observed that produce
farms generally do pack and hold food for introduction into interstate commerce, so it can and does inspect them
periodically, usually in areas associated with illness outbreaks or to conduct surveillance sampling. Source: U.S.
Congress, House Committee on Appropriations, Subcommittee on Agriculture, Rural Development, Food and Drug
Administration, and Related Agencies, Appropriations for 2008, 110th Cong., 1st sess., February 28, 2007 (Washington:
GPO, 2007), pp. Part 5, p. 479.
51 The FDA advisory panel acknowledged that “[t]he Agency conducts no inspections of retail food establishments or
of food-producing farms.” FDA Science and Mission at Risk: Report of the Subcommittee on Science and Technology,
November 2007, p. 21.
52 Most FDA guidance documents include the following: “FDA’s guidance documents, including this guidance, do not
establish legally enforceable responsibilities. Instead, guidances describe the Agency’s current thinking on a topic and
should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of
the word should in Agency guidances means that something is suggested or recommended, but not required.” Sources:
FDA, Guidance for Industry: Guide to Minimize Microbial Food Safety Hazards of Leafy Greens, Draft Guidance, July
2009; and FDA, Guide to Minimize Microbial Food Safety Hazards of Fresh-cut Fruits and Vegetables, February 2008.
53 FDA, Guide to Minimize Microbial Food Safety Hazards of Tomatoes, Guide to Minimize Microbial Food Safety
Hazards of Melons, and Guide to Minimize Microbial Food Safety Hazards of Leafy Greens. Available at FDA’s
website: http://www.fda.gov/Food/GuidanceCompliance
RegulatoryInformation/GuidanceDocuments/ProduceandPlanProducts/default.htm. 74 Federal Register 38437-38440,
August 3, 2009. See also FDA, “FDA Issues Draft Guidances for Tomatoes, Leafy Greens and Melons,” July 31, 2009.
54 FDA, “Prevention of Salmonella Enteritidis in Shell Eggs During Production, Storage, and Transportation; Final
Rule,” 74 Federal Register 33029, July 9, 2009. See also FDA, “Egg Safety Final Rule,” http://www.fda.gov/Food/
FoodSafety/Product-SpecificInformation/EggSafety/EggSafetyActionPlan/ucm170615.htm.
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known or reasonably foreseeable biological, chemical, and physical hazards, including natural
ones, that may be intentionally or unintentionally introduced. These regulations could include
minimum safety standards, and address manure use, water quality, employee hygiene, sanitation
and animal control, and temperature controls, as the Secretary determines to be reasonably
necessary. They may provide for coordination of education and enforcement activities and must
provide a reasonable time for compliance, taking into account the needs of small businesses for
additional time, among other permitted activities. The Secretary would be required to take into
consideration (consistent with public health) “the impact on small-scale and diversified farms,
and on wildlife habitat, conservation practices, watershed-protection efforts, and organic
production methods” (§ 104(b)(7)).
The Senate-passed bill also focuses on fresh produce, by requiring within one year proposed
regulations for the safe production, harvesting, handling and packing of those fruits and
vegetables (that are raw agricultural commodities) for which the HHS Secretary has determined
that such standards minimize the risk of serious adverse health consequences or death. Required
contents of the regulations do not appear to be as prescriptive as in the House-passed bill. The
Senate bill would encourage coordination with USDA and would require, as appropriate,
coordination with state agricultural agencies when enforcing standards. Enforcement could be in
the form of audit-based verification systems or other inspection methods. The bill includes
language to enable a state or foreign government to request a variance from HHS if needed to
account for local growing conditions. It would also require that any standards address growing,
harvesting, sorting, and storage; soil amendments, hygiene, packaging, temperature controls,
animal encroachment and water; and that the Secretary convene at least three public meetings to
seek input on the proposals.
In addition, the Senate bill would exempt some farms from the requirements under certain
conditions, as discussed in the next section, “Mitigating Effects on Small Business and Farming
Operations”.
Mitigating Effects on Small Business and Farming Operations
How Might Food Safety Proposals Affect Small Farms and Food Businesses?
Concerns among farm and rural groups about the potential effects of new food safety
requirements on farms and food processors surfaced early in the debate over how to reform U.S.
food safety laws. Most vocal were small farms and processors; organizations representing small,
organic, direct-to-market, and sustainable farming operations; and small livestock operations.55 At
issue is whether numerous proposed requirements would be more costly and burdensome to small
farms and other small businesses than could be justified by the potential public health protections
such requirements are intended to provide.
Considerations for small business could take many forms, including waiving certain
requirements, providing additional time for compliance, providing grants and/or technical
assistance to aid in compliance, and exempting certain types of businesses from meeting the
requirements. Currently the FFDCA exempts some types of businesses from certain food safety
requirements. For example, farms, restaurants, other retail food establishments, and certain
55 See CRS Report RL34612, Food Safety on the Farm: Federal Programs and Legislative Action.
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nonprofit food establishments and fishing vessels are exempt from facility registration
requirements under FFDCA § 415.
Various approaches might be used to define whether a farm or food processor is a “small”
business. Often, a definition may be based on a particular threshold value for a financial or
business measure, such as annual income or value of sales, numbers of employees, or other
measures.
With respect to farming operations, USDA typically relies on measures of gross cash income as a
measure of the size of a farm business. Gross cash income refers to the sum of all receipts from
the sale of crops, livestock, and farm-related goods and services, including any direct payments
from the government. For purposes of classifying farms, USDA defines a “small commercial
farm” as an operation with gross cash income of $10,000 to less than $250,000 annually; “large
farms” are defined as farms with gross cash income of $250,000 to less than $1 million.56 USDA
defines farms with gross cash income of less than $10,000 annually as very small, non-
commercial farms. Under these definitions, USDA data indicate that about one-third of all crop
and livestock producers are considered “small commercial” farms (Table 2). The share of small
commercial farms will vary depending on commodity. For example, among fruit and vegetable
producers who might be affected by requirements under the House and Senate food safety
measures, the share of small commercial farms is roughly 10% of all growers in this category.57
The size threshold used and the type of income counted to define a small business varies in
legislation and by agency. For example, the Small Business Administration (SBA) has set
different thresholds for defining a small business that vary considerably from USDA: among
most crop and livestock producers, SBA defines as a small business those who make no more
than $750,000 in sales per year.58 In some cases, however, USDA uses SBA’s definition for
defining a small business. Specifically, SBA’s threshold of $750,000 in annual sales is used by
USDA to determine small and very small meat and poultry plants as part of FSIS’s outreach and
oversight activities under its HACCP implementation and laboratory testing programs.59 Under
SBA’s business size standards, more facilities would be considered small businesses, with up to
one-half of all commercial crop and livestock producers defined as small.60
56 Hoppe, R.A., “U.S. Farm Structure: Declining—But Persistent—Small Commercial Farms,” Amber Waves, USDA,
September 2010; and Hoppe, R.A., Small Farms in the United States: Persistence Under Pressure, EIB-63, USDA,
February 2010. Based on 2007 survey data.
57 Ibid., Figure 3.
58 Small Business Size Regulations, Title 13 C.F.R. Part 121.
59 Correspondence between CRS personnel and askFSIS (http://www.fsis.usda.gov/).
60 Based on data on farms that make up to $1 million. USDA survey data are not published for farms that generate
between $500,000 and $750,000 in annual sales.
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Table 2. U.S. Farms and Food Manufacturers, 2007
(by size based on average annual sales receipts)
Farms and Food Manufacturing Establishments
Number
Percent
All Farms, Total
2,204,792
100.0%
Less than $10,000 (defined by USDA as “very small, non-commercial” farms)
1,271,735 57.7%
Between $10,000-$249,000 (defined by USDA as “smal commercial” farms)
715,947
32.5%
Between $250,000-$499,000
96,251
4.4%
More than $500,000
120,859
5.5%
All Food Manufacturing, Totala
Total, All Food Manufacturers
25,796 100.0%
Less than $500,000
8,906
34.5%
Selected Food Manufacturing Sectorsb
Grain and Oilseed Milling, Total 830
100.0%
Less than $500,000
71
8.6%
Fruit/Vegetable Manufacturing, Total
1,668
100.0%
Less than $500,000
203
12.2%
Dairy Product Manufacturing, Total
1,612
100.0%
Less than $500,000
174
10.8%
Animal Slaughtering and Processing, Total
3,817
100.0%
Less than $500,000
784
20.5%
Seafood Preparation/Packaging, Total
685
100.0%
Less than $500,000
114
16.6%
Bakeries/Tortilla Manufacturing, Total
10,269
100.0%
Less than $500,000
5,835
56.8%
Other Food Manufacturing, Total
3,310
100.0%
Less than $500,000
671
20.3%
Source: Data for farms are from USDA, 2007 Census of Agriculture, Table 58, December 2009. Data for
manufacturing establishments are from the U.S. Census Bureau’s 2007 County Business Patterns based on annual
survey data for al food manufacturers on the number of establishments by “enterprise receipt size,”
http://www.census.gov/econ/susb/.
Notes: “Average annual sales” includes market value of agricultural products sold and government payments.
Farm size designations are those described by USDA in Small Farms in the United States: Persistence Under Pressure,
EIB-63, February 2010, http://www.ers.usda.gov/publications/eib63/. For manufacturing, industry classification is
based on 2002 North American Industry Classification System (NAICS) codes.
a. Included in this total, but not shown separately are data for sugar and confectionery and animal food
manufacturing.
b. Ranked in order by NAICS code but including sugar and confectionery and animal food manufacturing.
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Elsewhere in farm legislation, such as in the periodic omnibus farm bill,61 adjusted gross income
(AGI) is an alternative income measure that is generally used to differentiate farm size. AGI is a
common measure of income for tax purposes, combining income from all sources. Business
income contributes to AGI on a net basis, that is, after business expenses. Thus, it is comparable
to profit: sales minus expenses and also taxable deductions. In the farm bill, an AGI limit is used
to differentiate wealthier farm households as a means test for the maximum amount of income
that an individual can earn and still remain eligible for commodity program benefits, including
any direct payments from the government. The 2008 farm bill tightened these limits by reducing
the AGI limit to $500,000 of non-farm AGI and $750,000 of farm AGI.62 Given that most
business information is proprietary, data are limited on the share of commodity producers (farms
and food processors) that have an annual AGI of less than $500,000. Information for U.S. farms
indicates that farms with less than $500,000 AGI account for more than 95% of all farms.63
Data are not available indicating what share of all farms also engage in food processing. Such
operations might include fruit and vegetable producers that pack or further process the produce
they grow by making products such as jams, jellies, or juices, or other processed fruit and
vegetable products; other examples might include dairies that are also producer-handlers that
bottle their own milk. Also, only limited data are available that generally characterize the market
and producer channels for so-called locally or sustainably produced foods, or other direct-to-
market foods.64
For food processors and manufacturers, often different business measures are used to define small
businesses. SBA definitions of small food processors are based on the number of employees at a
business. Given that most farms do not employ large numbers of workers, size standards based on
the number of employees are generally not applicable to farming operations. Among most food
processors, a small business is defined by the SBA as a business with no more than 500
employees.65 By this definition, nearly all (97%) of all food processors would be considered small
businesses based on U.S. Census Bureau data.66 The U.S. Census Bureau also tabulates data for
manufacturing facilities based on annual sales receipts (Table 2).
FDA regulations also define certain small food processing businesses, but they are case by case
and not inclusive. For example, FDA’s current HACCP regulations exempt “small” juice
processors as those “employing fewer than 500 persons.”67 Accordingly, available data indicate
that as many as 84% of businesses that make juice are not covered by the HACCP requirements.68
61 The most recent farm bill was the Food, Conservation, and Energy Act of 2008, P.L. 110-246. For more information,
see CRS Report RL34594, Farm Commodity Programs in the 2008 Farm Bill.
62 Ibid.
63 The White House, “Strengthening the Rural Economy—Improving America’s Support of Agriculture,”
http://www.whitehouse.gov/administration/eop/cea/factsheets-reports/strengthening-the-rural-economy/improving-
americas-support-of-agriculture. Based on USDA data from the 2007 Department of Agriculture’s Agricultural
Resource Management Survey: http://www.ers.usda.gov/Briefing/FarmIncome/govtpaybyfarmtype.htm.
64 See for example Martinez, S. et al., Local Food Systems, Concepts, Impacts, and Issues, ERR-97, USDA, May 2010,
http://www.ers.usda.gov/Publications/ERR97/ERR97.pdf; and Hoppe, R.A. et al., Small Farms in the United States,
Persistence Under Pressure, EIB-63, USDA, February 2010, http://www.ers.usda.gov/Publications/EIB63/EIB63.pdf.
65 Small Business Size Regulations, Title 13 C.F.R. Part 121.
66 Based on annual survey data for all food manufacturers on the number of firms broken out by employment size of the
enterprise. U.S. Census Bureau, 2007 County Business Patterns, http://www.census.gov/econ/susb/.
67 Hazard Analysis And Critical Control Point (HACCP) Systems, Title 21 C.F.R. Part 120.
68 U.S. Census Bureau, 2007 County Business Pattern. Data for “Frozen Fruit, Juice, and Vegetable Manufacturing.”
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Very small businesses are also exempt, and so defined by FDA if they meet one of the following
three criteria: “annual sales of less than $500,000, total annual sales greater than $500,000 but
total food sales less than $50,000, or operations that employ fewer than an average of 100 full-
time equivalent employees and sell fewer than 100,000 units of juice in the United States.”69
Available data indicate that about 12% of all fruit and vegetable manufacturers have annual sales
less than $500,000 (Table 2). Producers of “raw agricultural ingredients of juice,” such as fruit
and vegetable growers, are not covered by the HACCP requirements.
Legislative Proposals
Although both the House- and Senate-passed bills contain requirements that might affect small
business and farming operations, both bills also seek to take into account the needs of small
businesses and provide for coordination of enforcement and education activities with others such
as USDA and state authorities.
Several provisions in the House and Senate bills could potentially affect agricultural producers,
including smaller farms and food processors, as well as organic, direct-to-market, and sustainable
farming operations. The provisions that could have the most direct effect on on-farm activity,
especially produce growers, concern the establishment of new standards for produce safety (§ 104
and § 105, respectively). In addition, both bills would require the issuance of updated good
agricultural practices. Other bill provisions that could potentially affect small businesses and
farming operations include facility registration requirements (§ 101 of the House-passed bill; §
102 of S. 510); records access and/or inspection requirements (§ 106 of H.R. 2749; § 101 and §
204 of S. 510); food traceability requirements (§ 107 of H.R. 2749; § 204 of S. 510); hazard
analysis and risk-based preventive controls (§ 103 of S. 510); targeting of inspection resources (§
201 of S. 510); and changes in the reportable food registry (§ 112 of H.R. 2749). For more
information, see CRS Report RL34612, Food Safety on the Farm: Federal Programs and
Legislative Action.
The extent to which these other provisions might actually affect small business and farming
operations remains unclear, since the specific business requirements under these provisions would
be subject to agency rulemaking. In addition, what constitutes a “small” and a “very small”
business would be “as defined by the [HHS] Secretary” (see, for example, § 102 of the House-
passed bill, and §§ 103, 105, and 204 of S. 510).
The House-passed bill contains additional provisions intended to address potential effects of the
food safety requirements on small, organic, direct-to-market, and sustainable farming operations.
In particular, it would exempt from the facility registration requirements most commodity
producers that sell directly to consumers, including an “operation that sells food directly to
consumers if the annual monetary value of sales of the food products from the farm or by an
agent of the farm to consumers exceeds the annual monetary value of sales of the food products
to all other buyers” (§ 101(b)(1)). The House-passed bill also would require that any regulations
governing performance standards “take into consideration, consistent with ensuring enforceable
public health protection, the impact on small-scale and diversified farms, and on wildlife habitat,
conservation practices, watershed-protection efforts, and organic production methods” (§ 104(b)).
69 Hazard Analysis And Critical Control Point (HACCP) Systems, Title 21 C.F.R. Part 120.
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S. 510 was first modified by the Senate HELP Committee to require that the HHS Secretary
“provide sufficient flexibility to be applicable to various types of entities engaged in the
production and harvesting of raw agricultural commodities, including small businesses and
entities that sell directly to consumers, and be appropriate to the scale and diversity of the
production and harvesting of such commodities” (§ 103 and § 105, among other sections). Other
committee modifications required consideration of federal conservation and environmental
standards and policies including wildlife conservation, and assurances that these provisions will
not conflict with or duplicate those of the national Organic Foods Production Act (also § 105).
These provisions were retained in the Senate’s August 2010 manager’s amendment to S. 510.
The Senate manager’s amendment of August 2010 included additional modifications to address
the potential effects of the food safety requirements on small business and other farming
operations. These included allowances for HHS to exempt or limit compliance requirements for
certain types of farming operations and food processors, along with provisions that would allow
the HHS Secretary the discretion to exclude certain operations, if it is determined that these are
low risk and/or do not present a risk of “serious adverse health consequences or death.” Also
included were assurances that any new regulations would not conflict with or duplicate other
federal policies and standards, and that they would minimize regulatory burden and unnecessary
paperwork and the number of separate standards imposed on the facility (for example, the
registration, HACCP, produce standards, and traceability requirements in §§ 101, 103, 105, and
204). In addition, HHS would be required to publish “small entity compliance policy guides” to
assist small entities in complying with some proposed requirements, such as those regarding
registration, HACCP, produce standards, and traceability. Implementation would be delayed for
small and very small businesses (as defined by the Secretary) for the HACCP and produce
standards requirements, and there would be assurances of “sufficient flexibility” for producers,
including small businesses and entities that sell directly to consumers, for the HACCP, produce
standards, and traceability provisions.
Despite these additional modifications, Senator Jon Tester continued to push for further
amendments to address small farm interests. Senator Tester had first announced in spring 2010
that he planned to introduce two amendments to the Senate committee-reported bill, S. 510.70
Under one amendment, certain commodity producers would face limited traceback and record-
keeping requirements if the “average annual adjusted gross income [AGI] of such facility for the
previous 3-year period is less than $500,000”; another amendment would have exempted
producers who sell directly to market if “the annual value of sales of food directly to consumers,
hotels, restaurants, or institutions exceeds the annual value of sales of food to all other buyers.”71
These amendments were not included in the Senate manager’s amendment of August 2010.
In September 2010, Senator Tester, along with Senator Kay Hagan, announced an updated version
of this amendment.72 The modified Tester-Hagan amendment would establish “modified
requirements for qualified facilities” for so-called “very small” businesses, among other
provisions for both small and very small businesses (to be defined by HHS in regulation). Under
70 Senator Tester press release, “Tester to Introduce ‘Common Sense’ Amendments to Food Safety Bill,” April 14,
2010, http://tester.senate.gov/Newsroom/pr_041410_foodsafety.cfm (bill language is posted at website).
71 Ibid.
72 Press release, Senator Tester, “Updated Food Safety Amendment Protects Small Producers,” September 24, 2010,
http://tester.senate.gov/Newsroom/pr_092410_foodsafety.cfm. Bill language is available at http://tester.senate.gov/
Legislation/upload/Tester-Food-Safety-Amendment.pdf.
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this proposed amendment, certain qualified facilities would not be subject to certain food safety
requirements; instead they would be required to submit to HHS relevant documentation showing
that they have implemented preventive food safety controls and evidence that they are in
compliance with state, local, county, or other applicable non-federal food safety laws, among
other documentation. Such modified requirements would apply to producers considered “very
small” and would include operations that have annual sales of less than $500,000 (defined not as
AGI, but as the three-year average “annual monetary value of sales,” adjusted for inflation) and
whose value of sales directly to “qualified end-users” exceeds all other sales. Qualified end-users
would include consumers or a restaurant or retail food establishment that is located in the same
state or less than 400 miles73 from the qualified facility, or that is buying food for sale directly to
consumers. Implementation deadlines would also be delayed for small and very small businesses,
following promulgation of any applicable regulations under the newly enacted law. The provision
also would require that HHS conduct a study of the food processing sector, in conjunction with
USDA.
During the Senate floor debate in November 2010, a modified version of this amendment was
adopted as part of the substitute Senate amendment (S.Amdt. 4715) to S. 510. This version was
passed off the Senate floor on November 30, 2010. Consequently, the Senate-passed bill would
exempt certain food processing operations from the proposed HACCP requirements and also
would exempt certain farms from the new produce standards. Food facilities would qualify for an
exemption from the HACCP requirements under § 103 if they are either a “very small business”
as defined by FDA in rulemaking, or if the facility’s “average annual monetary value” of all food
sold during the previous three year period was less than $500,000, provided that the food is sold
directly to “qualified end users” such as consumers, restaurants, or retail food establishments
located in the same state where the facility sold the food or within 275 miles of the facility. Such
a facility would need to demonstrate that it either has “identified potential hazards associated with
the food being produced,” and is implementing and monitoring these preventive controls, or that
it is “in compliance with State, local, county, or other applicable non-Federal food safety law.”
Foods produced from such a facility would also need to provide the facility’s name and address
on a food packaging label or at the point of purchase.
Farms that would be exempt from the produce standards under § 105 also include those with a
three-year average monetary value of the food they sold of less than $500,000, provided that the
food is sold directly to the similarly defined “qualified end users” and if the farm provides similar
notification to consumers. The exemption for both facilities and farms may be revoked in the
event that a foodborne illness outbreak is directly linked to an exempted facility or farm, or based
on a determination by the HHS Secretary.
In addition, as discussed in the “Registration” section, although both the House and Senate bills
clarify the types of businesses that should be considered to be “retail food establishments” and
therefore generally not subject to the facility registration requirements, the Senate bill specifies
that roadside stands, farmers’ markets, and foods sold through a community-supported agriculture
(CSA) program would also not be subject to the requirements.
73 The 400-mile designation is similar to the distance specified in a provision of the Food, Conservation, and Energy
Act of 2008 (P.L. 110-246, Section 6015). That provision defines a “Locally or Regionally Produced Agricultural Food
Product” as any agricultural food product that is grown, produced, and distributed near where it is marketed such that
“the total distance that the product is transported is less than 400 miles from the origin of the product.”
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It is not possible to estimate what share of all food processing operations might be exempt from
the proposed HACCP requirements, how many farms might be exempt from the new produce
standards, or how other small business considerations might possibly mitigate the effects of these
and other requirements in the proposal. In part, this is because the definition of small and very
small business would be determined by HHS in future agency rulemaking and subject to other
requirements specified in the measures. Even though farms would continue to be exempt from the
proposed facility registration requirements, there are farms that also engage in food processing
that might be affected. Data are not available to determine what share of farms also engage in
food processing. In addition, other stipulations in S. 510 would require that foods be sold locally
and to certain qualified end-users. Data are also not available to determine what share of grower-
processors might qualify for such an exemption; such a determination would likely be made on a
case-by-case basis.
Throughout this debate, many farm groups have expressed support for the Tester-Hagan
amendment.74 However, one of the leading produce industry groups, United Fresh Produce
Association (UFPA), opposed the amendment and urged the Senate not to add “exemptions based
on the size of the operation, production practices, or geographic location for food being sold in
the commercial market” to its food safety proposal.75 In November during the floor debate, a
letter circulated from UFPA and 19 other producer associations again urging the Senate not to
adopt the amendment.76 In addition to broader industry concerns about the need to preserve
consumer confidence in the safety of all marketed produce, another industry concern is whether
small foreign producers might also be exempt, if small U.S. producers were to be exempt (given
prevailing U.S. equivalency standards).77
Meanwhile, some public health and consumer groups expressed concern that the Tester-Hagan
amendment would create “too great a loophole” in the food safety requirements, among other
concerns.78 In October 2010, a coalition of these groups expressed its opposition to the modified
version of the Tester-Hagan amendment.79 The groups cited concern that the exemption was
based only on sales volume and could result in certain high-risk foods being exempted from food
safety protections, and whether labeling requirements were needed for such foods. They argued
that it is unclear how many facilities would be exempted under the proposed sales threshold, and
74 See, for example, letter from more than 100 farm groups under the Small Holder Alliance, “Support Fresh, Safe
Local Food in the Food Safety Bill,” April 15, 2010, http://smallholdersalliance.com/Amend-S510-April-
15%20(2).pdf; and articles in Food Safety News (http://www.foodsafetynews.com/) by Helena Bottemiller, “Tester
Amendment Picks Up Cosponsor,” May 3, 2010, and “Farmers Gain in Senate Food Safety Battle,” April 15, 2010.
75 United Fresh Produce Association, 2010 Issues Brief, http://www.unitedfresh.org/assets/
Issue_Brief_United_Fresh_Produce_Association_2010.pdf.
76 Letter to Senators Reid, McConnell, Harkin, and Enzi from United Fresh Produce Association, Produce Marketing
Association, Northwest Horticultural Council, and other national and state groups, November 18, 2010, available at
http://www.unitedfresh.org/.
77 Ibid., comments by industry representatives at the UFPA’s 2010 Washington Public Policy Conference, September
15, 2010; and Helena Bottemiller, “Group Breaks Ranks on Small Farm Exemptions,” Food Safety News, September
10, 2010.
78 Letter to Senator Tester from the Consumers Union regarding Amendments to S. 510, the FDA Food Safety
Modernization Act, April 20, 2010, http://www.consumersunion.org/campaigns//notinmyfood/016345indiv.html; and
articles in Food Safety News (http://www.foodsafetynews.com/); Helena Bottemiller, “Public Health Opposition to
Tester Amendment,” April 28, 2010; Helena Bottemiller, “Farmers Gain in Senate Food Safety Battle,” April 15, 2010;
and Alex Ferguson, “What’s Wrong with the Tester Amendments,” May 4, 2010.
79 Make Our Food Safe coalition, October 19, 2010, http://www.makeourfoodsafe.org/. The coalition’s white paper on
the Tester-Hagan amendment is at https://ssl.capwiz.com/pew/attachments/TesterResponsefactsheetfinal.pdf.
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that FDA should conduct market analyses to determine appropriate thresholds for exemption in
both the produce and processed food sectors. They also questioned the appropriateness of the then
400-mile designation and other aspects of what would constitute a “direct sale” under the
proposed amendment, such as whether grocery stores and restaurants should be included.
Targeting of Inspections
How Often Should Plants Be Visited?
Reform advocates argue that many of the recent problems that have led to illness outbreaks and
recalls might have been avoided if inspectors were more frequently present in plants to monitor
sanitary conditions and processes.80 Due to the differing laws and circumstances that apply to
FSIS, for example, the agency’s inspectors are in meat and poultry slaughter and processing
plants every day, where they must organoleptically (by the senses) examine every live animal and
every carcass for defects, and must pass every item before it can enter commerce. The FFDCA
authorizes but does not require FDA to inspect food facilities. Therefore, no periodic inspection
frequency is currently stipulated. On the other hand, nothing in current law appears to prohibit
FDA from setting an inspection frequency, or prioritizing inspections based on risk.
Some, including former and current FDA officials, have argued that the agency lacks sufficient
resources to conduct the number of inspections required to ensure the safety of the food supply,
particularly in light of the increasing number of registered food facilities.81 (See Table 3.)
According to FDA budget documents, while the number of registered facilities has increased each
year since FY2004, the number of food inspectors decreased by about 15% from FY2004 to
FY2008. Due in part to arguments for increased funding, appropriations for the agency’s field
activities and full time equivalents (FTEs) have risen each fiscal year since FY2007. (In FDA
budget documents, inspection-related items appear under the field heading, and employees are
counted as FTEs.) According to the same budget documents, the number of inspections of food
facilities has increased each year since FY2008, yet is not projected to return to FY2004 levels
until FY2011.
One additional issue is how FDA can best target its available inspection resources to protect the
public health. Different facilities may not merit the same frequency of inspection. For example,
facilities that process and package food may create a greater opportunity for contamination than
warehouses that merely store foods. Companies and facilities that have a record of meeting all
FDA requirements may present less of a risk than those that do not. Foods produced in countries
with food processing and handling standards at least as rigorous as those of the United States may
present less of a health risk than those with less rigorous standards.
80 Lyndsey Layton, “FDA Inspections of Food Plants, Enforcement Down, Officials Say,” The Washington Post, April
7, 2010. This story refers to an HHS Inspector General report finding “significant weaknesses” in FDA’s domestic food
facility inspections program, including a significant decline in the number of inspections as well as a decline in the
number of violations identified by inspectors. HHS Office of Inspector General, “FDA Inspections of Domestic Food
Facilities,” OEI-02-08-00080, April, 2010, p. iii, http://oig.hhs.gov.
81 See, e.g., Hubbard, William, Former FDA Associate Commissioner for Policy and Planning, and Advisor, Alliance
for a Stronger FDA, March 11, 2009, testimony before the House Energy and Commerce Subcommittee on Health;
FDA Science Board, FDA Science and Mission at Risk: Report of the Subcommittee on Science and Technology,
November 2007; and “Science and Mission at Risk: FDA’s Self-Assessment,” January 29, 2008 Testimony of Peter
Barton Hutt before the Subcommittee on Oversight and Investigations, House Committee on Energy and Commerce.
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Table 3. FDA Food-Related Inspection Data, FY2004-FY2011
(budget for field salaries and expenses (S&E), number of field full-time equivalents (FTEs), total number of
FDA and state inspections, and cumulative number of domestic and foreign facilities registered under
FFDCA § 415)
FY2004 FY2005 FY2006 FY2007 FY2008 FY2009 FY2010 FY2011
Field S&E ($ in
millions)a
$299.3 $283.3 $285.3 $298.0 $340.6 $479,9 $547.5 $705.2
Field FTEsa
2,172 2,059 1,962 1,806 1,861 2,166 2,505 2,902
Inspectionsb
21,876 19,774 17,730 17,038 16,277 17,972 20,542 22,205
Domestic Facilitiesc 121,534 148,451 172,190 194,245 214,584 236,398 252,433d N/A
Foreign Facilitiesc
92,719 104,555 115,902 129,345 141,703 154,883 164,805d N/A
Source: Compiled by CRS from FDA annual budget documents for FY2006-FY2011.
a. Food field S&E and FTE data are from the FY2007-FY2011 annual Food and Drug Administration, President’s
Budget Request “All Purpose Table—Total Program Level,” except that the FY2004 numbers are from the
FY2006 annual Food and Drug Administration, President’s Budget Request, “Narrative by Activity, Foods—
Center for Food Safety and Applied Nutrition.” Appropriated funds are shown for FY2010; requested
funding levels are shown for FY2011. Actual funding levels are shown for FY2004-FY2009.
b. Inspection data are the reported Total FDA and State Contract Inspections, from the FY2006-FY2011
annual Food and Drug Administration, President’s Budget Request, Field Activities—Office of Regulatory
Affairs (ORA), “Foods Field Program Outputs—Domestic Inspections.” Numbers for FY2010 are
appropriated; for FY2011 are requested; al others are actual.
c. Source, FDA Office of Legislation on September 22, 2010.
d. Number of registrants as of September 22, 2010.
Legislative Proposals
The major proposals seek to improve both the targeting and frequency of in-plant inspections, but
in different ways. In general, the House-passed bill would require FDA to conduct inspections
more frequently than would the Senate bill. Both measures would allow the Secretary to prioritize
inspection resources according to the potential risk posed by particular types of foods, facilities,
and/or processes, although the House-passed bill is more prescriptive in its approach. (Relevant
sections in the House-passed bill are 105 and 207, and in the Senate-passed bill are 201 and 306.)
The House-passed bill would require the HHS Secretary to establish, within 18 months, a risk-
based schedule for inspecting each foreign and domestic food facility, following these prescribed
categories and frequencies: category 1, a high-risk food facility that manufactures or processes
food, must be inspected at least every 6-12 months; category 2, a low-risk facility that
manufactures or processes food or a facility that packs or labels food, must be inspected at least
every 18 months to three years; and category 3, a food facility that holds food, must be inspected
at least every five years.
The House-passed bill also would authorize the Secretary to modify the types of food facilities
within each category, and to alter inspection frequencies if needed to respond to illness outbreaks
and recalls. In doing so, the Secretary would be required to consider the type of food at the
facility, its compliance history, whether an importing facility is certified (under the new
certification requirements the bill would set; see below), and other factors determined relevant by
the Secretary.
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The House-passed bill also would authorize the Secretary to recognize a federal, state, or local
official to conduct domestic facility inspections and an agency or representative of a foreign
government to conduct foreign facility inspections. Foods would be deemed to be adulterated if
inspection were delayed, limited, or refused by either the owner, operator, or agent of an
establishment in which the foods were held, or by any agent of a governmental authority of a
foreign country within which an establishment that held the food were located.
Finally, the House-passed bill would require the Secretary to submit to Congress (1) annually, a
report containing the number and cost of risk-based inspections; and (2) within three years of
enactment, a report containing recommendations about the risk-based inspection schedule.
The Senate-passed bill would require the HHS Secretary to increase the inspection rate for any
food facility required to register under FFDCA § 415. In addition, the Secretary would be
required to identify high-risk facilities and to allocate resources to inspect facilities according to
known safety risks. Risks would include the type of food, the facility’s history of food recalls, the
facility’s hazard analysis and preventive controls, and others. The Secretary would be required to
inspect domestic high-risk facilities not less than once in the five-year period following
enactment, and not less than once every three years thereafter. The Secretary would be required to
inspect domestic non-high-risk facilities not less than once in the seven-year period following
enactment, and not less than once every five years thereafter. Also, the Secretary would be
required to inspect at least 600 foreign facilities in the year following enactment, and in each of
the subsequent five years to double the number of foreign facilities inspected. In meeting the
inspection requirements, the Secretary would be authorized to rely on inspections conducted by
other federal, state, or local agencies.
For foreign food facilities registered under FFDCA § 415, the Senate bill would permit the
Secretary to enter into arrangements and agreements with foreign governments to facilitate the
inspection of those facilities. The Secretary would be required to direct resources for inspection
of such foreign facilities, suppliers, and food types, particularly those identified as high-risk, to
help ensure the safety of the U.S. food supply. Notwithstanding any other provision of law,
foreign foods would be refused entry into the United States if inspectors were refused entry to a
facility, warehouse, or other establishment by the owner, operator, or agent in charge, or the
government of the foreign country. The Senate bill would also require the Secretary to allocate
resources to identify and inspect imported foods at ports of entry, according to the known safety
risks of the article of food, based on certain factors.
The Senate bill includes three provisions specific to seafood that focus on (1) establishing
interagency agreements to improve seafood safety (§ 201); (2) assessing changes to regulations
for post-harvest processing of raw oysters (§ 114); and (3) sending inspectors to assess production
of seafood imported into the United States (§ 306). The scope of interagency agreements
identified in § 201 includes examining and testing seafood; coordinating inspections;
standardizing data; modifying existing processes; sharing enforcement and compliance
information; and conducting joint training and outreach. Section 114 would require the Secretary
of HHS to submit a report to Congress before issuing guidance, regulation, or suggested
amendments related to post-harvest processing of oysters. It would also require GAO to review
the Secretary’s report and report its findings to Congress. These reports would be waived if a
consensus agreement is reached among federal and state regulators and the oyster industry, acting
through the Interstate Shellfish Sanitation Conference. Section 306 would permit the Secretary of
Commerce, in coordination with the Secretary of HHS, to send inspector(s) to a country or
facility of an exporter of seafood imported into the United States to assess practices and processes
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used in farming, cultivation, harvesting, preparation for market, and transportation of seafood.
Inspectors also may provide technical assistance related to these activities. Reports would be
required for each inspection to provide findings to the country or exporter and for use by the
Secretary of HHS.
The Senate bill would require the Secretary to submit to Congress not later than February 1 of
each year, and to make available to the public via FDA’s website, a report including certain
information about food facilities, food imports, and FDA foreign offices.
Use of Third Parties for Imports and for Laboratory Accreditation
Can Non-FDA Entities Help Ensure Safety?
Although FDA regulates importers and imported products, the agency does not have express
statutory authority to regulate private laboratories that sample or test imported foods, nor does
FDA accredit food laboratories or use others to certify the safety of imported foods. Presently,
laboratory accreditation is voluntary, and several domestic and international accreditation
organizations accredit laboratories.82 FDA may conduct voluntary, on-site assessments of private
accredited laboratories.83 FDA’s own laboratories are accredited and, according to FDA, “the
laboratory industry favors accreditation.”84 Industry participation in third-party certification
programs, such as those that help foreign and domestic producers meet FDA requirements
through certification, is also voluntary, although FDA has indicated that participation in such
programs may “be beneficial.”85 The FDA has also indicated that “there is extensive support for
certification programs that audit to determine compliance with internationally recognized
criteria,” and that domestic suppliers use third-party certification programs “in part because of
customer demand.”86
The Government Accountability Office testified in 2008 that private laboratory accreditation
“could leverage outside resources while providing FDA greater assurance about the quality of the
laboratories importers use to demonstrate that their products are safe.”87 In January 2009, FDA
issued draft guidance on accreditation standards for private laboratories and the test data that such
labs should submit to the agency for imported FDA-regulated products that were either detained
or subject to an FDA Import Alert.88 The guidance document encouraged importers to notify the
FDA in advance of their submission of a sample to an accredited laboratory, so as “to discourage
importers from withholding bad test results, re-testing, or re-sampling.”89 In January 2009, FDA
also issued a final guidance document on voluntary third-party certification programs for foods
82FDA, “Guidance for Industry: Submission of Laboratory Packages by Accredited Laboratories ,” 74 Federal Register
3056-3057, January 16, 2009, hereinafter Draft Guidance.
83 Ibid.
84 Ibid.
85 FDA, “Guidance for Industry: Voluntary Third-Party Certification Programs for Foods and Feeds ,” 74 Federal
Register 3058-3059, January 16, 2009.
86 Ibid.
87 Draft Guidance, supra note 54 (citing GAO, Federal Oversight of Food Safety—FDA’s Food Protection Plan
Proposes Positive First Steps, but Capacity to Carry Them Out is Critical, GAO-08-435T, at 7).
88 Draft Guidance.
89 Ibid.
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and animal feeds, which set forth attributes for third-party certification programs and procedures
for preventing conflicts of interest.
The use of third parties has been promoted as a method for helping FDA to carry out its
responsibilities and target enforcement and inspections while better using existing personnel.
Concerns have been expressed regarding testing and certification by third parties, and there has
been criticism regarding the autonomy given to the importers and private laboratories. Such
criticism varies from the manner in which the samples are collected for testing, to the reporting of
test results by the importers to the FDA, to whether test results accurately reflect all information
obtained, such as evidence of FFDCA violations, to potential or actual conflicts of interest.
Additionally, critics contend that although third-party certification may be useful as a commercial
marketing tool, it does not necessarily ensure safety, as manufacturers involved in recent
foodborne illness outbreaks have passed private third-party and state inspections. For example, in
two of the most publicized recalls over the last two years—the recall of 380 million eggs by a
single company and the recall of over 3,900 peanut products associated with another—both
companies had used outside labs and reportedly knew of positive test results for Salmonella in
their products prior to the recalls.90
Both the House and Senate bills address various ways to curb the potential for such problems
through laboratory accreditation and third-party certification programs. The question remains as
to whether industry will opt to use third parties.
Legislative Proposals
Under § 109 of the House-passed bill, qualified certifying entities are to be accredited and given
the responsibility to provide import certifications when the Secretary determines such
certifications are needed; generally, the specifics of that certification, including its format, would
be left to the Secretary’s regulatory discretion. The bill defines “qualified certifying entity” as “an
agency or a representative of the government from which the article originated, as designated by
such government or the Secretary; or an individual or entity determined by the Secretary or an
accredited body recognized by the Secretary to be qualified to provide a certification.” The House
bill would require the Secretary to issue regulations to ensure that certifying entities and their
auditors are free from conflicts of interest, and it contains extensive language on what these
regulations are to cover. The Secretary would have to require that, to the extent applicable, any
certification provided by a certifying entity be renewed whenever the Secretary deems it
appropriate; and the Secretary would have to refuse to accept any certification determined to be
no longer valid or reliable.
Section 110 of the House-passed bill also contains requirements for new laboratory accreditation
programs, testing of imported food by accredited laboratories, recognition of laboratory
accreditation bodies, advance notice to the Secretary prior to sample collection for testing, and
direct submission to the Secretary of laboratory analyses for certain analytical testing of food.
The Senate-passed bill (§ 303) also would create a system of accreditation of third-party auditors
and audit agents, who would certify that importing entities are meeting applicable FDA
90 FDA, Update on the Salmonella Typhimurium Investigation, FDA/CDC Joint Media Teleconference, (Jan. 28,
2009), at 9, http://www.fda.gov/downloads/NewsEvents/Newsroom/MediaTranscripts/UCM169176.pdf; Gardiner
Harris and William Neuman, Salmonella Found in ’08 at Egg Farm, N.Y. Times, (September 15, 2010), at B1.
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requirements. Foreign governments, foreign agricultural cooperatives, and other third parties
could apply to an accreditation body to be a third party auditor or audit agent, after the
accreditation body performs certain reviews. Accreditation bodies could not accredit a third-party
auditor unless it agrees to issue a written food or facility certification to accompany each food
shipment for import into the United States from an eligible entity. Accredited third-party auditors
or audit agents would be required to issue audit reports and immediately notify the Secretary of
discoveries during an audit of “a condition that could cause or contribute to a serious risk to the
public health.” The Senate bill also contains language regarding revocation of accreditation and
avoidance of conflicts of interest.
Section 202 of the Senate bill also includes provisions that would require the Secretary to
establish a program for testing of food by accredited laboratories and the recognition of
accreditation bodies to accredit laboratories, including state and local government laboratories.
The bill would require the development of model accreditation standards, re-evaluation of
accreditation bodies at least every five years, and a requirement that laboratory test results be sent
to the FDA unless the Secretary exempts the submission of test results after making a
determination that the results “do not contribute to the protection of public health.”
Mandatory Recall Authority
Removing Unsafe Foods from Commerce
Currently, neither FDA nor FSIS has explicit statutory authority to mandate a recall of most
adulterated foods, or to impose penalties if recall requirements are violated. FDA can order food
recalls only for infant formula.91 GAO and others have contended that these gaps increase the
possibility that unsafe food will not be recovered, and will be consumed.92 Significantly,
reversing their earlier opposition, many major food industry groups now endorse legislative
proposals to grant FDA mandatory recall authority for food.93
Defenders of the current system counter that the agencies already have sufficient authority to
keep tainted products from reaching consumers. FSIS’s statutory authority enables it to detain
meat and poultry products of concern for up to 20 days, and FDA’s authority enables it to detain
the foods it regulates for up to 30 days. Both agencies can, with a court’s permission, seize,
condemn, and destroy unsafe food.94 However, given FDA’s finite resources, these authorities
may not be practical or effective when large amounts of product are in wide distribution. Private
companies rarely fail to order a voluntary recall when problems arise, and some contend that
91 FDA has the authority to order recalls of four types of products: infant formula, medical devices, human tissue
products, and tobacco products. The agency may request that a company voluntarily recall other FDA-regulated
products, such as other foods, drugs, and cosmetics. See also discussion of the melamine contamination incident in
CRS Report R40916, Food Safety: Foodborne Illness and Selected Recalls of FDA-Regulated Foods.
92 See, for example, GAO, Food Safety: USDA and FDA Need to Better Ensure Prompt and Complete Recalls of
Potentially Unsafe Food (GAO-05-51), October 2004; and HHS Office of Inspector General (OIG), “FDA Inspections
of Domestic Food Facilities,” OEI-02-08-00080, April, 2010, http://oig.hhs.gov.
93 In reaction to a news story on an OIG report, representatives from the food industry noted the need for mandatory
recall in some instances. See “OIG Says Better FDA Traceback May Require New Legislation,” FDA Week, March 27,
2009.
94 A court’s permission may not be needed in all cases; for example, the FFDCA [§ 801(j)(1)] empowers officials to
hold an import for up to 24 hours if there is “credible evidence or information indicating that an article of food presents
a threat of serious adverse health consequences or death to humans or animals.”
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providing FDA with mandatory recall authority might foster a counterproductive adversarial
relationship between industry and government, slowing response times. Nonetheless, a number of
Members of Congress have supported GAO’s recommendation that legislation be considered to
strengthen the notification and recall authorities of both agencies.
Legislative Proposals
The House-passed bill (§ 111) would authorize the Secretary to request a voluntary recall by any
person who distributes an article of food that the Secretary has reason to believe is adulterated,
misbranded, or otherwise in violation of the FFDCA. It would further authorize the Secretary to
issue an order to cease distribution of any article of food if he/she has reason to believe that the
use or consumption of, or exposure to, that article of food may cause adverse health consequences
or death to humans or animals. An appeal process and other administrative matters are specified.
The Secretary would be required to issue a mandatory recall order if he/she determined that
problems were not adequately addressed through the procedures described above. The Secretary
could proceed directly to a mandatory recall order if he/she has credible evidence that an article
of food subject to an order to cease distribution presents an imminent threat of serious adverse
health consequences or death to humans or animals. In such case, the person would have to
immediately recall the food while stipulated appeal procedures were carried out. Failure to
comply with a mandatory recall order would be prohibited under FFDCA § 301. The House-
passed bill also would require the Secretary to provide notice of a recall order to consumers and
to state and local health officials; and to refuse admission to foods offered for import into the
United States if subject to a recall order or an order to cease distribution.
Other sections of the House-passed bill would require facilities to describe food recall procedures
in their food safety plans (§ 102), and importers to have adequate recall procedures (§ 108). In
addition, FDA could alter the frequency for risk-based inspection schedules based on the need to
respond to food recalls (§ 105), and could assess and collect fees from entities for any fiscal year
in which the entity is subject to a food recall (§ 204).
The Senate-passed bill (§ 206) would require the HHS Secretary, if he/she has information “that
there is a reasonable probability that an article of food (other than infant formula) is adulterated ...
or misbranded ... and the use of or exposure to such article will cause serious adverse health
consequences or death to humans or animals,” to provide an opportunity to the responsible party
to cease distribution and recall the food. If the party did not do so “within the time and in the
manner prescribed by the Secretary,” authority would be provided to require such person to cease
distribution, or to immediately notify everyone involved in handling or receiving the food. The
Secretary would be required to provide specified notifications to the public of any recall orders,
and to establish an incident command or similar operation within the department to assure
coordinated communications during a recall. The bill provides for the assessment of civil
penalties as well as criminal penalties with regard to failure to comply with or follow a recall
order. The assessment of civil penalties for failure to comply with a recall order may preclude the
assessment of criminal penalties. If the FDA assesses a civil penalty, the agency would not be
able to seek seizures or injunctions for the adulterated food.
Notification of Contaminated Products and Product Tracing
Improving Notification and Traceability Capabilities
Notification and traceability are viewed as tools to make recalls more effective. Some have
argued that improved notification and traceability capabilities would enable either FSIS (in the
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case of meat and poultry products) or FDA (in the case of other foods) to determine more quickly
a product’s source and whereabouts, in order to prevent or contain foodborne outbreaks.
Traceability has also been debated in connection with defense against agroterrorism, and for
verifying the origin of live animals and their products for marketing, trade, and/or animal health
purposes, for example. In some recent highly publicized outbreaks, it appears that food company
representatives were aware of a food safety problem for a prolonged period of time before
notifying FDA.95
The 110th Congress responded to some of these concerns by including a provision in the Food and
Drug Administration Amendments Act of 2007 (P.L. 110-85) that requires the responsible party
for a food facility (i.e., registered under FFDCA § 415) to notify the Secretary of any food “for
which there is a reasonable probability that the use of, or exposure to, such article of food will
cause serious adverse health consequences or death to humans or animals,” and that requires the
Secretary to establish a Reportable Food Registry of such reports.96 Also, the enacted 2008 farm
bill (P.L. 110-246) amends the meat and poultry laws to require an establishment to notify USDA
if it has reason to believe that an adulterated or misbranded product has entered commerce. (See
also the earlier discussion of current record-keeping requirements under FFDCA § 414.)
Legislative Proposals
The House-passed bill (§ 112) would amend current authority for the Reportable Food Registry to
expand the definition of who must report problem foods. In addition to persons who register
facilities under FFDCA § 415, persons who own or operate farms and retail establishments would
also have to report, as would persons who register importing facilities under FFDCA § 801. In
addition, the bill would require submission of results of any sampling or testing of a reported
food, including tests conducted pursuant to the bill’s proposed hazard analysis and preventive
controls provisions, food safety plans, performance standards, or testing by accredited
laboratories.
The House-passed bill (§ 107) also would require the Secretary to establish by regulation a
tracing system for food in, or to be imported into, the United States, in order to enable the
Secretary “to identify each person who grows, produces, manufactures, processes, packs,
transports, holds, or sells such food in as short a timeframe as practicable but no longer than 2
business days.” Before promulgating regulations, the Secretary would be required first to identify
tracing technologies and methodologies that can enable each of the food industry sectors to
maintain the full pedigree of the food from source through subsequent distribution, to make
traceback interoperable with other systems, and to use a unique identifier for each facility. Also
prior to proposing regulations, the Secretary would first have to, as practicable, assess costs,
benefits, and feasibility of adopting such technologies; conduct at least two public meetings; and
conduct one or more pilots.
The House bill’s traceback requirements would apply to agricultural producers, fisheries (both
wild and aquaculture), and retailers, but there is extensive language intended to limit the
95 See, for example, documentation on the 2010 Wright County egg recall available at the House Committee on Energy
and Commerce website: “Chairmen Request More Details on Salmonella Contamination at Wright County Egg
Publications,” September 14, 2010. See also discussion of the melamine contamination incident in CRS Report
R40916, Food Safety: Foodborne Illness and Selected Recalls of FDA-Regulated Foods.
96 FFDCA § 417; 21 U.S.C. 350f. After some delays, the Reportable Food Registry was implemented in September
2009. See the FDA website at http://www.fda.gov/Food/FoodSafety/FoodSafetyPrograms/RFR/default.htm.
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applicability to farms. For example, the bill would exempt food produced on a farm or fishery and
sold directly to a consumer, restaurant, or grocery store. However, restaurants and grocery stores
would be required to keep records documenting the farm or fishery source. Farms or fisheries
would have to keep records for at least six months documenting the restaurants and groceries to
which they sold their food. The Secretary could also exempt a food or a type of facility, farm, or
restaurant from the regulations, or modify the requirements for these entities, if he/she
“determines that a tracing system for such food ... is not necessary to protect the public health.”
For this latter category of exemptions, each person who produces, manufactures, processes,
packs, transports, or holds such food still would have to maintain records that identify the
immediate previous sources of the food and its ingredients and the immediate subsequent
recipients. The Secretary would be required to coordinate with USDA, and tracing authority
would be constrained with regard to growers of grains or similarly handled commodities.
The Senate-passed bill (§ 211) would amend current authority for the Reportable Food Registry
to allow the Secretary to require the submission by a responsible party of additional types of
information about a reportable food in order to improve consumers’ ability to identify it. The bill
also would require grocery stores to conspicuously post one-page information sheets about
reportable foods, to be developed by FDA and made available for copying on the agency’s
website. A store’s failure to comply would be prohibited.
The Senate bill (§ 204) proposes a food tracing system that is generally similar to the one
proposed by the House-passed bill, although different in numerous details. Rather than calling for
a tracing system for all foods, from which low-risk foods may be exempted, it would require the
Secretary, through rulemaking, to impose enhanced recordkeeping requirements (under FFDCA §
414) for foods that the Secretary determines to pose a higher food safety risk. A number of
limitations of such requirements are stipulated, especially with respect to farms and agricultural
commodities. Effective dates for the record-keeping requirements would be delayed for small
businesses. The bill also would require the Secretary to conduct pilot studies and assessments of
food tracing systems to inform the rulemaking process.
Foodborne Illness Surveillance and Outbreak Response
How Might Data Collection and Use Be Strengthened?
Foodborne illness surveillance is carried out by the states, with assistance from CDC. States also
investigate foodborne disease outbreaks, in coordination with CDC, either or both FDA or FSIS
(depending on implicated or suspected foods), and other federal agencies, if appropriate. FDA is
authorized to carry out such investigations, or to coordinate with states in doing so, under broad,
permanent authorities in the FFDCA and in Title III of the Public Health Service Act (PHS Act),
among other authorities.97 A foodborne disease outbreak is not defined in law or in regulations. In
public health practice, a foodborne disease outbreak is “the occurrence of two or more cases of a
similar illness resulting from the ingestion of a common food.”98 As a practical matter,
particularly for less serious hazards, outbreak investigations are rarely launched when only two
people are affected. (There are exceptions for serious illnesses such as botulism.)
97 FFDCA at 21 U.S.C. § 372 and 21 U.S.C. § 399; Public Health Service Act at 42 U.S.C. § 241, 42 U.S.C. § 243, 42
U.S.C. § 247b, 42 U.S.C. § 247b-20, and 42 U.S.C. § 264.
98 CDC, “Surveillance for Foodborne-Disease Outbreaks: United States, 1998–2002,” Morbidity and Mortality Weekly
Report (MMWR), vol. 55 (Surveillance Summary 10), pp. 1-34, November 10, 2006.
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The nation’s public health capacity for foodborne illness surveillance and outbreak response is a
mix of significant strengths and significant gaps.99 In the last decade or so, the linkage of
previously unrelated illnesses through genetic “fingerprinting” has revolutionized the ability to
identify large multistate outbreaks and mount an urgent response. However, the epidemiological
approaches used to identify the food associated with an outbreak can be labor-intensive and time-
consuming. Also, especially for FDA-regulated foods, information about common contaminants
that may be present in foods during production and in commerce, as well as how to test for them,
is limited. As a result, “attribution”—identifying the types of foods that cause foodborne
illnesses—remains a significant challenge. The daunting outbreaks of the past few years
underscore the problem, but are not the only evidence. Based on data from FoodNet, its active
surveillance system, CDC reported that as of 2009, the incidence of several of the foodborne
diseases under surveillance had reached a plateau, instead of declining, and that national 2010
health targets for three out of four targeted pathogens—Campylobacter, Listeria, and
Salmonella—may not be met.100
Because regulators regulate foods, rather than food contaminants, many contend that closing the
attribution gap is paramount in order to target preventive strategies efficiently and mount a more
nimble response to outbreaks. The President’s Food Safety Working Group stated one of its three
core food safety principles as follows: “High-quality information will help leading agencies know
which foods are at risk; which solutions should be put into place; and who should be
responsible.”101 Achieving this goal is a challenge, raising concerns about available technologies,
scientific soundness, intellectual property, “trade secret” protections, liability, and other issues.
Stakeholders discussed these issues at an FDA-sponsored public workshop in March 2010.102
Legislative Proposals
The House-passed bill (§ 121) would, for purposes of surveillance, define a foodborne illness
outbreak as two or more cases of a similar illness resulting from the ingestion of a food. The bill
would require the Secretary, acting through the CDC, to enhance foodborne illness surveillance
systems, including coordinating federal, state, and local systems; facilitating timely sharing of
agency findings; ensuring early notification of the food industry when a particular food is
suspected in an outbreak; developing improved epidemiological tools; and other prescribed
methods. The bill also would mandate a review of and strategies to enhance the food safety and
defense capabilities of state and local agencies.
The Senate-passed bill (§ 205) contains provisions that generally mirror the House bill. It
contains additional provisions that would establish a working group to improve foodborne illness
surveillance and outbreak investigations, and would reauthorize food safety capacity-building
grants to states and Indian tribes under the PHS Act. It also would authorize the appropriation of
$24 million for each fiscal year for FY2011 through FY2015 for efforts to enhance foodborne
illness surveillance.
99 See CRS Report R40916, Food Safety: Foodborne Illness and Selected Recalls of FDA-Regulated Foods.
100 CDC, “Preliminary FoodNet Data on the Incidence of Infection with Pathogens Transmitted Commonly Through
Food–10 States, 2009,” MMWR, vol. 59, no. 14 (April 16, 2010), pp. 418-422, http://www.cdc.gov/foodnet/. CDC
reported that the target for harmful strains of E. coli had been met.
101 President’s Food Safety Working Group, “Key Findings,” March 2009, http://www.foodsafetyworkinggroup.gov/
ContentKeyFindings/HomeKeyFindings.htm.
102 FDA, “Measuring Progress on Food Safety: Current Status and Future Directions; Public Workshop,” 75 Federal
Register 9232, March 1, 2010.
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Criminal Penalties
Existing Criminal Penalties Under FFDCA § 303(a)
The concepts of “adulteration” and “misbranding” are two of the basic statutory components of
the FFDCA. FDA-regulated foods may be deemed adulterated or misbranded for a variety of
statutorily prescribed reasons. For example, food may be deemed adulterated if it contains an
added poisonous or deleterious substance or an unsafe food additive or if the food was prepared,
packed, or held under insanitary conditions whereby it may have become contaminated or may
have been rendered injurious to health.
Persons who violate the FFDCA by, for example, introducing an adulterated or misbranded
product into interstate commerce, commit what is referred to as a prohibited act under FFDCA §
301.103 Persons who commit prohibited acts are subject to criminal and civil penalties. The
penalties vary, depending on the offense. Most criminal liability provisions are found in the
“Penalties” section of the FFDCA, § 303. Injunctions and seizures may also be sought for
adulterated or misbranded products. In light of a number of deaths that appear to have resulted
from contaminated food, such as nine deaths linked to tainted peanut butter products, some have
called for stronger criminal penalties than the current fines and maximum of three years’
imprisonment.104
Presently, upon conviction for a misdemeanor violation of the prohibited acts section, a person105
faces the penalties authorized in FFDCA § 303(a).106 These are presented in Table 4. The
maximum criminal penalty for individuals (as adjusted by 18 U.S.C. §§ 3559 and 3571) is
imprisonment for one year and/or either $100,000 if the misdemeanor does not result in death, or
$250,000 if the misdemeanor results in death. The maximum criminal penalty for organizations
(as adjusted by 18 U.S.C. §§ 3559 and 3571) is $200,000 if the offense does not result in death
and $500,000 if the offense results in death. There are exceptions to the misdemeanor penalties
provisions in FFDCA § 303(a)(1). A person could avoid being subject to penalties for certain
violations of the prohibited acts section under the good faith exception, and persons may also
avoid liability for violations of certain prohibited acts if they receive a guaranty from the
manufacturer or the person from whom they received the product.107
103 21 U.S.C. § 331.
104 See U.S. Congress, House Committee on Energy and Commerce, Do You Fix Our Ailing Food Safety System, 111th
Cong., 1st sess., March 11, 2009 (http://energycommerce.house.gov/Press_111/20090311/testimony_dewaal.pdf); see
also U.S. Congress, Senate Committee on the Judiciary, statement of Sen. Patrick Leahy, Chairman, Executive
Business Meeting of the S. Comm. on the Judiciary, 111th Cong., 2nd sess., September 23, 2010
(http://judiciary.senate.gov/hearings/testimony.cfm?id=4808&wit_id=2629).
105 The FFDCA defines “person” to include individuals, partnerships, corporations, and associations, though criminal
statutes distinguish between individuals and organizations in setting fine amounts. FFDCA § 201(e); 18 U.S.C. §§
3559, 3571.
106 21 U.S.C. § 333(a)(1). In United States v. Dotterweich, the U.S. Supreme Court held that the government need not
prove that the defendant intended to commit a FFDCA violation in order to obtain a misdemeanor conviction.
Misdemeanor violations of the FFDCA are strict liability offenses. United States v. Dotterweich, 320 U.S. 277, 284
(1943); see also United States v. Park, 421 U.S. 658 (1975).
107 21 U.S.C. § 303(c)(1)-(3). FFDCA § 301(h) prohibits a person from giving a false guaranty to another person that a
food is not adulterated.
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Table 4. Criminal Penalties for Violations of FFDCA § 303(a)
Maximum Criminal
Maximum Criminal
Penalty for
Penalty for Individuals
Organizations (as
Description of Statutory
(as adjusted by 18 U.S.C.
adjusted by 18 U.S.C.
Statute
Provision
§§ 3559 and 3571)
§§ 3559 and 3571)
Current Law provisions
Federal Food, Drug,
Violation of FFDCA prohibited
Imprisonment for one year
$200,000 if the offense
and Cosmetic Act
acts provisions, FFDCA § 301
and/or either $100,000 if
does not result in death,
(FFDCA) § 303(a)(1)
the misdemeanor does not
$500,000 if the offense
result in death, or $250,000
results in death.
(21 U.S.C. § 333(a)(1))
if the misdemeanor results
in death.
FFDCA § 303(a)(2)
Violation of FFDCA prohibited
Imprisonment for not more
A fine of not more than
acts provisions after a prior
than 3 years or a fine of not
$500,000.
(21 U.S.C. § 333(a)(2)) conviction under FFDCA § 303 more than $250,000, or
or a violation committed with
both.
the intent to defraud or
mislead
Proposed changes
Proposed FFDCA §
Knowing violation of certain
Imprisonment for not more
A fine of not more than
303(a)(3), as set forth
FFDCA prohibited acts
than 10 years or a fine of
$500,000.
in H.R. 2749
provisions with respect to any
not more than $250,000, or
food that is misbranded or
both.
adulterated
Proposed FFDCA §
Knowing violation of certain
Imprisonment for not more
A fine of not more than
303(a)(3), as set forth
FFDCA prohibited acts
than 10 years or a fine of
$500,000.
in S. 3767a
provisions with respect to any
not more than $250,000, or
food and with conscious or
both.
reckless disregard of a risk of
death or serious bodily injury
Source: Prepared by CRS.
a. Not included in the Senate-passed bill, S. 510.
A violation of the FFDCA’s prohibited acts section is a felony offense if it occurs after a prior
conviction for violating the FFDCA’s prohibited acts section or if it is committed with the intent
to defraud or mislead. The maximum criminal penalty for individuals convicted of a felony
violation of the FFDCA (as adjusted by 18 U.S.C. §§ 3559 and 3571) is imprisonment for not
more than three years or a fine of not more than $250,000, or both. The maximum criminal
penalty for organizations (as adjusted by 18 U.S.C. §§ 3559 and 3571) is a fine of not more than
$500,000.
Criminal liability may also extend to persons who aid and abet criminal violations of the FFDCA,
or who conspire to violate the FFDCA, as federal criminal law generally makes it a separate
crime to aid or abet any criminal offense against the United States or to conspire to commit a
criminal offense against the United States.108 The decision to seek criminal sanctions against
individuals and corporations suspected of violating the FFDCA is within the FDA’s discretion.109
108 18 U.S.C. §§ 2, 371.
109 Heckler v. Chaney, 470 U.S. 821 (1985) (holding that “[t]he FDA’s decision not to take the enforcement actions
(continued...)
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Prosecution may be more likely if the case involves “gross, flagrant, or intentional violations,
fraud, or danger to health” or “a continuous or repeated course of violative conduct.”110
Legislative Proposals
Section 134 of the House-passed bill would amend the penalties provisions of FFDCA § 303(a) to
provide for fines and a maximum prison sentence of 10 years if any person knowingly violated
any one of five listed prohibited acts with respect to food that is misbranded or adulterated. The
five prohibited acts listed in § 134 are (1) FFDCA § 301(a), which prohibits “the introduction or
delivery for introduction into interstate commerce” of any food that is adulterated or misbranded;
(2) FFDCA § 301(b), which prohibits adulteration or misbranding of food in interstate commerce;
(3) FFDCA § 301(c), which prohibits the “receipt in interstate commerce” as well as “the delivery
or proffered delivery thereof for pay or otherwise” of adulterated or misbranded food; (4) FFDCA
§ 301(k), which prohibits the “alteration, mutilation, destruction, obliteration, or removal of the
whole or part of the labeling of, or the doing of any other act with respect to, a food ... if such act
is done while such article is held for sale (whether or not the first sale) after shipment in interstate
commerce and results in the article being adulterated or misbranded”; and (5) FFDCA § 301(v),
which prohibits the “introduction or delivery for introduction into interstate commerce” of an
unsafe dietary supplement.
The maximum criminal penalty for individuals convicted of a felony violation of the FFDCA for
knowingly violating any one of these five parts of the FFDCA’s prohibited acts section, with
respect to any adulterated or misbranded food, would be a fine of not more than $250,000. Such
individuals would also face a maximum prison sentence of 10 years in addition to the fine, as the
individual could be fined, imprisoned, or both. The maximum criminal penalty for organizations
for such violations would be a fine of not more than $500,000.
The Senate-passed bill would not alter the criminal penalties under FFDCA § 303(a). It had been
reported that if S. 510 were to be considered by the Senate, another bill, S. 3767 (the Food Safety
Accountability Act of 2010, introduced by Senator Patrick Leahy), could be offered as a further
amendment to it. A substitute amendment to S. 3767 was approved by the Senate Judiciary
Committee on September 23, 2010, and the bill as amended was reported by the committee on the
same day. However, S. 3767 does not appear to have been included in the Senate amendment to
S. 510 that passed off the Senate floor on November 30, 2010.
S. 3767, as reported, would also amend the penalties provisions of FFDCA § 303(a) to provide
for fines and a maximum prison sentence of 10 years if a person knowingly violated one of five
parts of the FFDCA’s prohibited acts section. S. 3767 lists the same five prohibited acts that
appear in H.R. 2749, § 134. However, S. 3767 differs from the criminal provisions in the House
bill in that it contains an additional requirement that the knowing violation be “with respect to
food and with conscious or reckless disregard of a risk of death or serious bodily injury.”
(...continued)
requested by respondents is therefore not subject to judicial review under the [Administrative Procedure Act]” and that
the FFDCA enforcement provisions do not overcome the agency’s “decisions not to institute proceedings”).
110 FDA, Regulatory Procedures Manual, § 6-5-1, March 2010, http://www.fda.gov/ICECI/ComplianceManuals/
RegulatoryProceduresManual/ucm176738.htm.
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The maximum criminal penalties for violations would be the same as proposed by the House-
passed bill. The maximum criminal penalty for individuals convicted of a felony violation of the
FFDCA for knowingly violating these parts of the FFDCA’s prohibited acts section, “with respect
to food and with conscious or reckless disregard of a risk of death or serious bodily injury,”
would be a fine of not more than $250,000, imprisonment for up to 10 years, or both. The
maximum criminal penalty for organizations for such violations “with respect to food and with
conscious or reckless disregard of a risk of death or serious bodily injury” would be a fine of not
more than $500,000. Changes proposed by the House-passed bill and by S. 3767 are presented in
Table 4.
Food Imports
Concerns About Import Oversight
A steady increase in food imports, a result of globalization and consumer desire for a wider
variety of foods year-round, has generated growing concerns about whether current federal
programs sufficiently ensure the safety of these imports.111 FDA import alerts in 2007 and 2008
targeting adulterated pet food ingredients, farmed seafood, and dairy products and ingredients, all
from China, have been among the incidents that have heightened interest in this issue. Most of the
recent debate has included extensive discussion about how to improve current import safeguards,
within resource constraints, and without unduly restraining free trade.112
The FFDCA (at 21 U.S.C. § 381(a)) empowers FDA to refuse entry to any food import if it
“appears,” based on a physical examination or otherwise, to be adulterated, misbranded, or
otherwise in violation of the law. In exercising its oversight, the agency relies on a system of prior
notifications by importers and document reviews at ports of entry. Importers must have an entry
bond and file a notification for every shipment. An FDA database, the Operational and
Administrative System for Import Support (OASIS), helps inspectors to determine a shipment’s
relative risk and whether it needs closer scrutiny (i.e., a physical examination, and/or testing). In
practice, import inspections are relatively infrequent. The agency recorded more than 8.2 million
imported food “lines” in FY2007 (compared with fewer than 2.8 million entry lines in FY1997),
of which approximately 1% were physically examined and/or tested.113 Among the cited reasons
for this low incidence in inspections are limited and declining resources, including too few
inspectors to cover the more than 360 U.S. ports of entry despite ever-increasing import
volumes.114 Current law also does not explicitly authorize, or require, import verification.
111 GAO, Food Safety: Agencies Need to Address Gaps in Enforcement and Collaboration to Enhance Safety of
Imported Food, GAO-09-873, September 15, 2009; GAO, Food Safety: FDA Could Strengthen Oversight of Imported
Food by Improving Enforcement and Seeking Additional Authorities, GAO-10-699T, May 6, 2010. See also CSPI,
“Building a Modern Food Safety System for FDA Regulated Foods, May 2009.
112 Additional information is available in CRS Report RL34198, U.S. Food and Agricultural Imports: Safeguards and
Selected Issues.
113 FDA briefing for Senate staff, February 8, 2008. FDA FY2009 budget materials state that 94,743 import food field
exams were conducted in FY2007.
114 See, for example, Testimony of Caroline Smith DeWaal, CSPI Director of Food Safety, before the House Energy
and Commerce Committee’s Subcommittee on Oversight and Investigations, July 17, 2007.
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In addition, some have questioned whether FDA has what is called “equivalence authority”, such
as that governing U.S. imports of meat and poultry products under USDA’s FSIS jurisdiction.115
“Equivalency” refers to the requirement that all imported meat and poultry products meet all
safety standards applicable to similar products produced in the United States. Foreign meat and
poultry food regulatory systems may apply “equivalent sanitary measures to eliminate or abate
food safety hazards” if those measures provide the same “level of public health protection”
achieved by U.S. measures.116 Under laws governing meat inspection,117 no foreign establishment
can ship its products to the United States until FSIS has determined that the establishment’s
country has a meat and/or poultry safety program that provides a level of protection that is at least
equivalent to the U.S. system. FSIS visits the exporting country to review its rules and
regulations, meets with foreign officials, and accompanies them on visits to establishments. In
addition, FSIS operates a reinspection program at 150 import houses located near approximately
35 border entry points. FDA does not have a program like that of FSIS. Some have suggested that
the FDA program should operate more like that of FSIS, although they acknowledge the
difficulties and resource demands of attempting to regulate many more different types of foods
from many countries of origin.118
Legislative Proposals
Both the House-passed and Senate-passed bills seek tighter controls over imports, and both would
use certification or verification systems involving so-called third parties. More specifically, under
the House-passed bill (§ 109), the Secretary would have to require, as a condition of granting
admission for an imported food article, that a “qualified certifying entity provide a certification
that the article complies with specified requirements” of the FFDCA. This requirement would
take effect on or after three years from the date of enactment. However, such certification would
apply only in the following situations:
• for food imported from a particular country or region, based on the adequacy of
government controls there or other relevant information, if such certification
would assist in determining the admissibility of the food;
• for a food type that could pose a significant risk to health, if such certification
would assist in determining whether the article poses such risk; or
• for an article imported from a particular country, if the Secretary has an
agreement with that government providing for such certification.
Another section of the House-passed bill (§ 204) would require a food importer to register
annually with the Secretary, to submit an appropriate unique facility identification as a condition
of such registration, and to meet “good importer practices;” the latter to include verification of
good manufacturing practices and preventive controls of the importer’s foreign suppliers, as
applicable, among other things. A provision in this section would require every person importing,
115 Ibid.
116 According to USDA, the concept that different sanitary measures can achieve the same level of protection is called
equivalence. See: USDA, Food Safety And Inspection Service, “Process for Evaluating the Equivalence of Foreign
Meat and Poultry Food Regulatory Systems,” October 2003, http://www.fsis.usda.gov/oppde/ips/eq/eqprocess.pdf.
117 Federal Meat Inspection Act, 21 U.S.C. §§ 601-695; and Poultry Products Inspection Act, 21 U.S.C. §§ 451-471.
118 See for example Testimony of Caroline Smith DeWaal, CSPI Director of Food Safety, before the House Energy and
Commerce Committee’s Subcommittee on Oversight and Investigations, July 17, 2007.
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or brokering for import of, a food to permit an officer or employee of the Secretary to “inspect the
facilities of such person and have access to, and to copy and verify, any related records.” Any
food offered for import that is not from a duly registered person would be misbranded. (Fees are
to be charged and are discussed later in this report.)
The Senate-passed bill (§ 303) contains a provision that would authorize the HHS Secretary,
based on public health considerations, including risks associated with food or its place of origin,
to require food imports to be accompanied by “certification or such other assurances as the
Secretary determines appropriate” that the food complies with some or all requirements of the act.
Among other provisions, certifications would be used for designated food imported from
countries where FDA has an agreement for a certification program. Certifying entities would be
an agency or representative from the originating country or such other persons as accredited
elsewhere (see section titled “Use of Third Parties for Imports and for Laboratory Accreditation”).
The Senate bill (§ 301) also would authorize a “Foreign Supplier Verification Program,” generally
requiring each importer to perform foreign supplier verification activities in accordance with
regulations the Secretary would issue to ensure compliance with relevant FFDCA provisions.
Each importer’s program would be able to assure that each of its foreign suppliers produces the
imported food employing processes and procedures, “including reasonably appropriate risk-based
preventive controls” that are documented in a written plan and equivalent in preventing
adulteration and reducing hazards as required by other relevant provisions of the FFDCA.
Verification activities would include monitoring records, lot-by-lot certification of compliance,
annual on-site inspections, checking the preventive control plan of the foreign supplier, and
periodically testing and sampling shipments. Importers would maintain import verification
program records for at least two years and make them available to the Secretary upon request.
The House bill also contains provisions regarding foreign supplier verification (including
provisions in §§ 204, 205, 206, and 136).
Among separate but related provisions in both the House and Senate bills are specific
authorizations for the Secretary to review the equivalence of a foreign country’s safety standards,
regulations, statutes, and controls and to conduct audits to verify their implementation; and to
enter into arrangements with foreign countries to facilitate inspection of foreign facilities.
Another feature of both bills would require the establishment of a program to expedite imports
from those who voluntarily agree to certain higher safety standards. This program is called a
“Safe and Secure Food Importation Program” in the House-passed bill (§ 113) and a “Voluntary
Qualified Importer Program” in the Senate bill (§ 302).
Bisphenol A (BPA)
Are Food Containers with BPA Safe? Are Alternatives Available?
Bisphenol A (BPA) is a component of certain plastics. When used in food containers, such as
plastic bottles or metal can liners, BPA is regulated by the FDA. Scientific disagreement about
possible human health effects that may result from BPA exposure has led to conflicting regulatory
decisions regarding the safety of these food containers, especially when intended for use by
infants and children.119 FDA’s conclusion in 2008 that BPA use is safe conflicted with findings of
119 For additional background information, see CRS Report RS22869, Bisphenol A (BPA) in Plastics and Possible
Human Health Effects.
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advisory panels. This prompted some to question FDA’s risk assessment process, and its ability to
conduct such assessments. Recently, FDA expressed concern about possible health effects from
BPA exposure, and announced that it was conducting new studies on the matter, pending possible
changes in its regulatory approach.
In March 2009, several manufacturers of baby bottles announced that they would stop selling
BPA-containing bottles in the United States, partly in response to growing numbers of retailers
that would no longer carry the products.120 However, manufacturers of cans maintain that suitable
alternatives to BPA are not available and are not likely to become available in the immediate
future. Until alternatives for all uses are developed, they argue that BPA-containing liners will be
necessary to ensure a tight seal on cans and lids, and thus to prevent food spoilage and food
poisoning risks to consumers. Manufacturers are seeking alternatives to meet consumer demand,
but development will take time as new containers are produced and tested for diverse foods with
different properties.121
Legislative Proposals
The House-passed bill (§ 215) would require FDA to determine whether there was “a reasonable
certainty of no harm for infants, young children, pregnant women, and adults, for approved uses
of polycarbonate plastic and epoxy resin made with bisphenol A in food and beverage containers
... under the conditions of use prescribed in current [FDA] regulations.” FDA would be required
to notify Congress about any uses of BPA for which a determination of safety could not be made,
and how the agency would regulate such uses to protect public health.
The Senate-passed bill does not contain a provision regarding BPA. It is reported that Senator
Dianne Feinstein had sought unsuccessfully to incorporate S. 593, the Ban Poisonous Additives
Act of 2009, a bill she sponsored that would ban BPA in all FDA-regulated food containers, or a
modification of that bill.122
Paying for Food Safety with User Fees
How Much Is Needed and Who Should Pay?
Many critics have argued that—irrespective of the need, if any, to reform food safety statutes and
organization—a fundamental problem has been FDA’s stated lack of sufficient funding and staff
to carry out congressionally mandated (and existing) responsibilities to ensure a safe food
supply.123 Responding to a request from Democratic leaders of the House Energy and Commerce
Committee, a subcommittee of the FDA Science Board124 estimated that, in order to address these
120 Lyndsey Layton, “No BPA for Baby Bottles in U.S.,” The Washington Post, March 6, 2009.
121 Lyndsey Layton, “Replacing BPA in Cans Gives Foodmakers Fits; FDA Safety Concerns Prompt Scramble to
Remove the Chemical,” The Washington Post, February 23, 2010.
122 Ben Moscovitch, “Food Safety Passage Hurdles Persist as Senate Begins Deliberations,” InsideHealthPolicy.com,
November 18, 2010.
123 See, e.g., FDA Science Board, FDA Science and Mission at Risk: Report of the Subcommittee on Science and
Technology, November 2007.
124 The Science Board is one of several advisory committees to FDA. It consists of experts from academia and industry,
and advises the Commissioner on specific complex and technical issues, as well as emerging issues within the scientific
community, in industry and academia. It also provides advice to the Agency on keeping pace with technical and
(continued...)
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deficiencies, the food-related portion of FDA’s appropriation should be increased.125 In fact,
congressional appropriators have increased funding for FDA food activities in recent years.126
(See Table 5.)
Table 5. FDA Direct Appropriations for Foods, FY2005-FY2011
(dollars in millions)
FY2005
FY2006
FY2007
FY2008
FY2009
FY2010
FY2011
actual
actual
actual
actual
actual
appropriation
request
Appropriations
435.5 438.7 457.1 507.8 712.8
784.1 1,041.9
Source: Compiled by CRS from FDA annual budget documents. Data are from the FY2007-FY2011 annual Food
and Drug Administration, President’s Budget Request “All Purpose Table—Total Program Level.”
Proposed increases in program spending raise a variety of policy issues. Requests for higher
appropriations compete with other priorities throughout the federal discretionary budget. The
programs do not operate as mandatory authorizations as do farm support programs, for example,
and currently are being made during a period of budget deficits.
An alternative approach to direct appropriations that has been used in some other areas of FDA is
to fill perceived shortfalls through new user fees on the regulated industry. User fees related to
foods have been proposed in legislation and in budget requests over time. The FY2011
President’s budget request proposed $6.467 million for reinspection fees, $4.307 million for
export certification fees, and $182.783 million in inspection and registration fees. To date, no
such user fees for foods have been explicitly authorized.
Currently, FDA’s authority to collect user fees extends to human and animal prescription drugs
and human medical devices (21 U.S.C. 379g - 379j-12);127 human biologics (42 U.S.C. 262 note);
and tobacco products (21 U.S.C. 387s). Some of these user fees are paid annually, and some are
paid when submitting certain applications to FDA. The fees collected are intended to be used to
fund approval-related activities; with the exception of tobacco fees, they can not be used to fund
enforcement or inspection activities for products on the market, except to a very limited extent.
(Unlike foods and some food additives, prescription drugs, medical devices, and animal drugs
require FDA’s advance permission before they can be legally marketed.) The user fee programs
have generally been authorized in five-year increments (except for tobacco fees, which are
permanently authorized). Each authorization specifies the fee amounts FDA may collect annually,
among other legislative direction.
(...continued)
scientific evolutions in the fields of regulatory science, formulating appropriate research agendas, and upgrading its
scientific and research facilities to keep pace with these changes. FDA, Science Board to the Food and Drug
Administration, October 6, 2010, http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/
ScienceBoardtotheFoodandDrugAdministration/default.htm.
125 Estimated Resources Required for Implementation, report of the Science Board’s Subcommittee on Science and
Technology in response to the request of Representatives Dingell, Waxman, Stupak, and Pallone, February 25, 2008.
126 See CRS Report R40792, Food and Drug Administration Appropriations for FY2010.
127 See CRS Report RL34571, Medical Device User Fees and User Fee Acts; CRS Report RL33914, The Prescription
Drug User Fee Act (PDUFA): History, Reauthorization in 2007, and Effect on FDA; and CRS Report RL34459,
Animal Drug User Fee Programs.
Congressional Research Service
43
Food Safety in the 111th Congress: H.R. 2749 and S. 510
FDA is also authorized to collect export certification fees for drugs, animal drugs, medical
devices and biological products (21 U.S.C. 381(e)(4)). A person who exports any of these
products may request that the Secretary certify in writing that the product meets FFDCA
requirements. If the Secretary issues a written export certification, a fee of up to $175 may be
charged.
The introduction of user fees for other FDA-regulated products has added to the agency’s budget.
Fees have provided additional resources for the agency to hire reviewers to conduct premarket
reviews; to hire support personnel and field investigators to speed up the application review
process for drugs, biological products, and medical devices; and to acquire and support critical
information technology infrastructure.128
The introduction of fees has also raised the following four issues, among others, which are
applicable to policy discussions about food fees. First, proposals for new user fees typically meet
with resistance, both from the companies that would have to absorb such costs and from
consumer advocates, who argue that industry funds might cause conflicts of interest by having
industry pay the salaries of some of its regulators. (Certain types of fees, such as for facility
registration, have not been as vociferously opposed by some consumer advocates.) To help
address the issues that underlie this resistance, clear conflict-of-interest guidelines as well as
certain restrictions on how funds may be expended have been created in other areas.
Second, concerns are sometimes expressed that user fees, once authorized, comprise an ever-
increasing proportion of the budget, and may supplant rather than supplement funding for the
agency. For that reason, certain fees carry the requirement that direct appropriations meet a certain
threshold before user fees can be collected.129
Third, the funding generated by some types of fees—those that are periodic and associated with
external events such as the submission of marketing applications—can be difficult to predict.
However, FDA’s highly trained staff can not easily be increased or trimmed to conform to short-
term activity levels and associated available funds. One example of the dilemma of unpredictable
fee funding comes from the area of medical device user fees. In FY2002, when they were initially
authorized, the fees were all periodic, which led to unpredictable funding for the device program
and caused some budgetary shortfalls.130 In FY2007, in order to make user fee funding more
consistent and reliable, certain annual fees (such as annual registration fees) were enacted to help
resolve the issue.131
A fourth set of concerns has been raised by small businesses. In the area of drugs and devices,
small businesses claim to be drivers of innovation, and caution that fees imposed on them have a
disproportionate and chilling effect on their work. For that reason, many of the drug- and device-
related user fees have reductions for small businesses.
128 For an example regarding drugs, see U.S. Congress, House Committee on Energy and Commerce, Subcommittee on
Health, Prepared Statement of Hon. Lester M. Crawford, Deputy Commissioner, Food and Drug Administration,
Reauthorization of the prescription Drug User Fee Act, 107th Cong., 2nd sess., March 6, 2002, f:78503.wais
(Washington: GPO, 2002), pp. 30-31.
129 See CRS Report RL34334, The Food and Drug Administration: Budget and Statutory History, FY1980-FY2007.
130 See Barbara Zimmerman, Medical Device Review Program Performance, FDA, Webcast, 2010,
http://www.fda.gov/downloads/MedicalDevices/NewsEvents/WorkshopsConferences/UCM224256.wmv.
131 Id., and see CRS Report RL34571, Medical Device User Fees and User Fee Acts; and CRS Report RL34465, FDA
Amendments Act of 2007 (P.L. 110-85).
Congressional Research Service
44
Food Safety in the 111th Congress: H.R. 2749 and S. 510
Legislative Proposals
Each proposal would fund some FDA food safety activities through the collection of user fees,
though the types of fees and details differ. (See Table 6.) The House-passed bill would establish
two annual fees (a facility registration fee and an importer registration fee), and two fees related
to periodic activities (a reinspection and recall fee, and an export certification fee). The Senate
bill would establish one annual fee (for participants in the voluntary qualified importer program
(VQIP)), and three fees for periodic activities (a reinspection fee, a recall fee, and an export
certification fee). Details of these fees are presented in Table 7 and Table 8, including, where
specified, who pays the fee, the fee amount, restrictions on the fee amount, the result of
nonpayment, how funds may be used, required reports and meetings, authorizations,
appropriations-related restrictions on fee collection, and expiration dates. For fees paid annually,
see Table 7. For periodic fees, see Table 8.
Table 6. Fees in the House-Passed Bill (H.R. 2749) and the Senate-Passed Bill (S. 510)
H.R. 2749, House-passed
S. 510, Senate-passed
Facility Registration Fee
§ 101
None
Importer Registration Fee
§ 204
None
Reinspection Fee
§ 108
§ 107
Recall Fee
§ 108 (for all recalls)
§ 107 (for noncompliance with recall)
Export Certification Fee
§ 203
§ 401
VQIP Fee
None
§ 107
Source: Prepared by CRS based on the text of the House-passed and Senate-passed bills (H.R. 2749 and S. 510).
The House-passed bill would authorize higher fees, would carry a higher total price tag, and
would mandate more frequent inspections than the Senate bill (as discussed in the front matter
and inspection-related sections of this report). Regarding fees, the Congressional Budget Office
(CBO) estimates that over five years, the House-passed bill would collect $1.4 billion and the
Senate bill would collect $241 million (based on an assessment of the August 2010 manager’s
amendment).132 CBO also estimates that covering the five-year cost of new requirements,
including more frequent inspections, would require additional outlays of $2.2 billion under the
House-passed bill, and $1.1 billion under the Senate bill.133
The Senate-passed bill would exclude certain small businesses from FFDCA § 415 registration
requirements, as discussed in the “Mitigating Effects on Small Business and Farming Operations”
section. While this exclusion would not reduce the amount of fees collected under the Senate-
passed bill (which has no registration fee), it would reduce the fees collected under the House-
passed bill (which has a registration fee). As the Senate has passed S. 510, as amended by
S.Amdt. 4715, the issue of which facilities must register and whether and how many fees would
be collected could remain an issue to be reconciled between the House and Senate, and could
affect the CBO score of the resulting legislation.
132 Ellen Werble, Rebecca Yip, and Zachary Epstein et al., H.R. 2749: Food Safety Enhancement Act of 2009,
Congressional Budget Office, July 24, 2009, p. 5, http://www.cbo.gov/ftpdocs/104xx/doc10478/hr2749.pdf. Ellen
Werble, Stephanie Cameron, and Susanne Mehlman et al., S. 510: Food Safety Modernization Act, Congressional
Budget Office, August 12, 2010, p. 6, http://www.cbo.gov/ftpdocs/117xx/doc11794/s510.pdf.
133 Note that the CBO scores in this paragraph are specific to FDA costs. For that reason, they are somewhat lower than
amounts discussed earlier this report, which reflect estimated total federal costs.
Congressional Research Service
45
Table 7. Comparison of Annual Fees in the House-Passed Bill (H.R. 2749) and the Senate-Passed Bill (S. 510)
H.R. 2749, House-passed
S. 510, Senate-passed
Category
Facility Registration Fee
Importer Registration Fee
VQIP Fee
Who Pays
Facilities required to register under
Importers required to register under new
Importers participating in the voluntary importer certification
amended FFDCA § 415.
FFDCA § 801(s).
program, under new FFDCA § 806.
Fee Amount
$500/facility (inflation adjusted annually).
$500/importer (inflation adjusted
Amounts estimated as specified to cover 100% of the VQIP
annual y).
costs for that year.
Fee Amount Cap
$175,000/person with multiple facilities
None.
None.
(not inflation-adjusted).
(Note: The Secretary must waive either the facility or importer fee for persons
otherwise required to pay both.)
Result of
Fees over 30 days past due treated as a
Nothing fee-specific, but registration
Fees over 30 days past due treated as a claim of the U.S.
Nonpayment
claim of the U.S. Government under 31
under new FFDCA § 801(s) may be
Government under 31 U.S.C., chapter 37, subchapter II
U.S.C., chapter 37, subchapter II (Claims
suspended or cancelled for FFDCA
(Claims of the United States Government).
of the United States Government).
violations; foods are deemed misbranded
if imported by an importer not duly
registered under § 801(s).
How Funds May Be
For food safety activities, as defined.
For registering importers under new
For administering the VQIP program.
Used
FFDCA § 801(s) and ensuring compliance
with good food importer practices.
Required Reports,
Secretary must: (1) submit to Congress
None.
Secretary must: (1) publish within 180 days of enactment a
Meetings
an annual report on the implementation
proposed set of guidelines related to the burden of fee
of the authority and use of the fee; (2)
amounts on smal businesses; (2) submit to Congress, not
hold an annual public meeting on how the
later than 120 days after each fiscal year in which fees are
fees would be used and collected.
assessed, a specified report describing fees assessed and
collected, entities paying such fees, and their types of
business.
Authorization
Such sums as may be necessary for each
Such sums as may be necessary for each
For FY2010 and each FY thereafter, an amount equal to the
of FY2010 through FY2014.
of FY2010 through FY2014.
revenue amount determined as specified.
Appropriations-
Fees must be refunded if appropriations
None.
Fees must be refunded if appropriations for FDA’s food
Related Restrictions
for FDA’s salaries and expenses (total,
safety activities, excluding fees, are less than the preceding
on Fee Collection
not just for food) are less than the
year’s appropriations adjusted for inflation, as specified.
preceding year’s appropriations adjusted
for inflation, as specified.
Expiration Date
Fee sunsets after FY2014.
None.
None.
Source: Prepared by the CRS based on the text of the House-passed and Senate-passed bills (H.R. 2749 and S. 510).
CRS-46
Table 8. Comparison of Periodic Fees in the House-Passed Bill (H.R. 2749) and the Senate-Passed Bill (S. 510)
H.R. 2749, House-passed
S. 510, Senate-passed
Category
Reinspection and Recall
Export Certification
Fee
Fee
Reinspection Fee
Recall Fee
Export Certification Fee
Who Pays
Facilities that must undergo an
Exporters who voluntarily
If subject to reinspection
If noncompliant with a
Exporters who voluntarily
additional inspection for
request and receive within
in a fiscal year: the
recall order under
request and receive within
violating the FFDCA; or are
20 days Secretary’s export
responsible party for a
FFDCA § 412(f) or new §
20 days Secretary’s export
subject to a food recall.
certification under
domestic facility (defined in 423: the responsible party certification under
amended FFDCA
new FFDCA § 415(b)), the
for domestic facilities
amended FFDCA
§ 801(e)(4).
U.S. registered agent for a
(defined in new FFDCA §
§ 801(e)(4).
foreign facility, or the
415(b)), or the importer.
importer.
Fee Amount
Secretary sets fees at a level to
Secretary sets inflation-
Secretary annual y
Secretary annual y
Fees may cover the cost of
ful y cover cost of
adjusted fee annually.
establishes fees for
establishes fees to cover
certification.
reinspections and/or recalls.
facilities and for importers
100% of estimated cost of
so each fee covers 100% of food recal activities
the respective estimated
associated with such
reinspection-related costs.
order performed by the
Secretary.
Fee Amount Cap /
Secretary waives / refunds fees
Fee may not exceed
The amount of fees
The amount of fees
Fee may not exceed $175
Waiver
resulting from inappropriately
amount reasonably related
collected may not exceed
collected may not exceed
per certification.
ordered recalls.
to the cost of issuing
$25 million in a given FY,
$20 million in a given FY,
certificates.
except that if a domestic
except that if a domestic
facility or importer
facility or importer
becomes subject to a fee
becomes subject to a fee
in a given year, the
in a given year, the
Secretary may collect it.
Secretary may collect it.
Result of
No provision in § 108 of bill.
No provision in § 203 of
Fees over 30 days past due treated as a claim of the U.S. No provision in § 107.
Nonpayment
bill.
Government under 31 U.S.C., chapter 37, subchapter II
(Claims of the United States Government).
How Funds May Be
For recall and reinspection.
For issuing certifications.
For reinspection-related
For food-recall-related
For issuing certifications.
Used
activities.
costs associated with the
recal order, for activities
performed by the
Secretary.
CRS-47
H.R. 2749, House-passed
S. 510, Senate-passed
Category
Reinspection and Recall
Export Certification
Fee
Fee
Reinspection Fee
Recall Fee
Export Certification Fee
Required Reports,
None.
None.
Secretary must: (1) publish within 180 days of
None.
Meetings
enactment a proposed set of guidelines related to the
burden of fee amounts on smal businesses; (2) submit
to Congress, not later than 120 days after each fiscal
year in which fees are assessed, a specified report
describing fees assessed and col ected, entities paying
such fees, and their types of business.
Authorization
Such sums as may be necessary
Fees shall be collected in
For FY2010 and each FY thereafter, an amount equal to
No provision in § 107.
for each of FY2010 through
each FY in an amount
the revenue amount determined as specified.
FY2014.
equal to the amount
specified in appropriations
acts.
Appropriations-
None.
None.
Fees must be refunded if appropriations for FDA’s food
None.
Related Restrictions
safety activities, excluding fees, are less than the
on Fee Collection
preceding year’s appropriations adjusted for inflation, as
specified.
Expiration
Date
None.
None. None. None. None.
Source: Prepared by the CRS based on the text of the House-passed and the Senate-passed bills (H.R. 2749 and S. 510).
CRS-48
Appendix A. Snapshot of Provisions in the House-Passed Bill (H.R. 2749) and
the Senate-Passed Bill (S. 510), Ranked by Section Number
Subject Matter
H.R. 2749 (House-passed)
S. 510 (Senate-passed)
PROVISIONS ACCORDING TO SECTIONS OF H.R. 2749, IN NUMERICAL ORDER
Jurisdiction
Rules of Construction (§ 4); USDA Exemptions (§ 5); Alcohol-
Jurisdiction; Authorities (§ 403); Alcohol-Related Facilities (§
Related Facilities (§ 6); Extraterritorial Jurisdiction (§ 213)
116); Compliance With International Agreements (§ 404)
Food Facility Registration Requirements
Changes in Registration of Food Facilities (§ 101)
Registration of Food Facilities (§ 102)
Hazard Prevention Plans
Hazard Analysis, Risk-Based Preventive Controls, Food Safety
Hazard Analysis and Risk-Based Preventive Controls (§ 103)
Plan, Finished Product Test Results from Category 1 Facilities
(§ 102)
Performance Standards
Performance Standards (§ 103)
Performance Standards (§ 104)
Produce Safety Standards
Safety Standards for Produce and Certain Other Raw
Standards for Produce Safety (§ 105)
Agricultural Commodities (§ 104)
Inspection of Facilities
Risk-Based Inspection Schedule (§ 105)
Targeting of Inspection Resources for Domestic Facilities,
Foreign Facilities, and Ports of Entry; Annual Report (§ 201)
Recordkeeping Requirements and FDA
Access to Records (§ 106). See also the records provisions in
Inspections of Records (§ 101). See also “Enhancing Tracking
Access to Records
“Traceability of Food,” § 107, and “Registration for Customs
and Tracing of Food and Recordkeeping,” § 204
Brokers,” § 205
Traceability of Food
Traceability of Food (§ 107); Unique identification number for
Enhancing Tracking and Tracing of Food and Recordkeeping (§
food facilities, importers, and custom brokers (§ 206)
204)
Funding and Fees
Changes in Registration of Food Facilities (§ 101); Reinspection Authority to Collect Fees (§ 107); Funding for Food Safety (§
and Food Recall Fees Applicable to Facilities (§ 108);
401)
Exportation Certificate Program (§ 203); Registration for
Commercial Importers of Food; Fee (§ 204)
Third Party Accreditation
Certification and Accreditation (§ 109, part)
Accreditation of Third-Party Auditors (§ 307)
Laboratory Accreditation
Testing by Accredited Laboratories (§ 110)
Recognition of Laboratory Accreditation for Analyses of Foods
(§ 202)
Mandatory Recall Authority
Notification, Nondistribution, and Recall of Adulterated or
Mandatory Recal Authority (§ 206)
Misbranded Food (§ 111)
Reportable Food Registry
Reportable Food Registry: Exchange of Information (§ 112)
Improving the Reportable Food Registry (§ 211)
Expediting Imports
Safe and Secure Food Importation Program (§ 113)
Voluntary Qualified Importer Program (§ 302)
CRS-49
Subject Matter
H.R. 2749 (House-passed)
S. 510 (Senate-passed)
Infant Formula
Infant Formula (§ 114)
No comparable provision.
Foodborne Illness Surveillance and
Surveillance (§ 121)
Surveillance (§ 205)
Education
Public Education and Advisory System (§ 122)
Research
Research (§ 123)
Food Safety Integrated Centers of Excel ence (§ 210)
Seizure of Food
Procedures for Seizure (§ 131)
No comparable provision.
Administrative Detention of Food
Administrative Detention (§ 132)
Administrative Detention of Food (§ 207)
Quarantine Authority
Authority to Prohibit or Restrict the Movement of Food (§
No comparable provision.
133)
Criminal Penalties
Criminal Penalties (§ 134)
No comparable provision.
Civil Penalties
Civil Penalties for Violations Relating to Foods (§ 135)
No comparable provision.
Import Entry Filings (See also “Foreign
Improper Import Entry Filings (§ 136)
No comparable provision.
Supplier Verification,” below.)
Food Substances Generally Recognized As
Food Substances Generally Recognized As Safe (§ 201)
No comparable provision.
Safe (GRAS)
Country-of-Origin Labeling (COOL)
Country of Origin Labeling (§ 202)
No comparable provision.
Export Certification Fees
Exportation Certificate Program (§ 203)
Authority to Collect Fees (§ 107)
Foreign Supplier Verification
Registration for Commercial Importers of Food; Fee (§ 204);
Foreign Supplier Verification Program (§ 301)
Registration for Customs Brokers (§ 205); Unique
Identification Number for Food Facilities, Importers and
Customs Brokers (§ 206); Improper Import Entry Filings (§
136)
Inspection of Foreign Facilities
Prohibition Against Delaying, Limiting, or Refusing Inspection (§ Inspection of Foreign Food Facilities (§ 306)
207); Risk-Based Inspection Schedule (§ 105, part);
Certification and Accreditation (§ 109, part)
FDA Foreign Offices
Dedicated Foreign Inspectorate (§ 208)
Foreign Offices of the Food and Drug Administration (§ 308)
Other Laboratory Provisions
Plan and Review of Continued Operation of Field Laboratories
Integrated Consortium of Laboratory Networks (§ 203)
(§ 209)
False or Misleading Reporting to FDA
False or Misleading Reporting to FDA (§ 210)
No comparable provision.
FDA Subpoena Authority
Subpoena Authority (§ 211)
No comparable provision.
Whistleblower Protection
Whistleblower Protections (§ 212)
Employee Protections (§ 402)
CRS-50
Subject Matter
H.R. 2749 (House-passed)
S. 510 (Senate-passed)
See “Jurisdiction” row of Appendix B for § 213 of H.R. 2749 regarding extraterritorial jurisdiction.
State and Local Food Safety Roles and
Support for Training Institutes (§ 214)
Improving the Training of State, Local, Territorial, and Tribal
Training
Food Safety Officials (§ 209); Enhancing Food Safety (§ 210)
Bisphenol A (BPA)
Bisphenol A in Food and Beverage Containers (§ 215)
No comparable provision.
Lead in Ceramics
Lead Content Labeling Requirement for Ceramic Tableware
No comparable provision.
and Cookware (§ 216)
PROVISIONS ACCORDING TO SECTIONS IN S.Amdt. 4715 to S. 510 THAT HAVE NOT ALREADY BEEN LISTED, IN NUMERICAL ORDER
Intentional Adulteration and Domestic Food Hazard Analysis, Risk-Based Preventive Controls, Food Safety
Protection Against Intentional Adulteration (§ 106); National
Defense
Plan, Finished Product Test Results from Category 1 Facilities
Agriculture and Food Defense Strategy (§ 108); Food and
(§ 102)
Agriculture Coordinating Councils (§ 109); Building Domestic
Capacity (§ 110)
Sanitary Transportation of Food
No comparable provision.
Sanitary Transportation of Food (§ 111)
Food Al ergy and Anaphylaxis
No comparable provision.
Food Al ergy and Anaphylaxis Management (§ 112)
Vitamins and Minerals Containing Anabolic
No comparable provision.
New Dietary Ingredients (§ 113)
Steroids
Seafood
No comparable provisions.
Requirements for Guidance Relating to Post Harvest
Processing of Raw Oysters (§ 114); Updating Guidance
Relating to Fish and Fisheries Products Hazards and Controls
(§103, part)
Port Shopping
No comparable provision.
Port Shopping (§ 115)
See “Jurisdiction” row of Appendix B for § 116 of S. 510 regarding alcohol.
Food Decontamination and Disposal
No comparable provision.
Decontamination and Disposal Standards and Plans (§ 208)
Import Certification
Certification and Accreditation (§ 109, part)
Authority to Require Import Certifications for Food (§ 303)
Prior Notice of Imports
No comparable provision.
Prior Notice of Imported Food Shipments (§ 304)
Foreign Capacity Building
No comparable provision.
Building Capacity of Foreign Governments with Respect to
Food (§ 305)
Smuggled Food
No comparable provision.
Smuggled Food (§ 309)
Pay-As-You-Go
No comparable provision.
Determination of Budgetary Effects (§ 405)
Source: Table created by CRS based on the text of the House-passed and the Senate-passed bills (H.R. 2749 and S. 510). Provisions are listed in
numerical order by section number, beginning with sections in H.R. 2749, followed by sections in S. 510 not yet presented.
CRS-51
Appendix B. Comparison of Current Law with Provisions in the House-Passed
Bill (H.R. 2749) and the Senate-Passed Bill (S. 510)
Background, Applicable Current Law, and
Administration Statements
H.R. 2749 (House-passed)
S. 510 (Senate-passed)
PROVISIONS ACCORDING TO SECTIONS OF H.R. 2749, IN NUMERICAL ORDER
JURISDICTION
The preemption doctrine is derived from the Supremacy
Rules of Construction (§ 4)
Jurisdiction; Authorities (§ 403)
Clause of the U.S. Constitution, which establishes that the
laws of the United States “shall be the supreme law of the
The preemption provision states that “Nothing in this Act
Not a preemption provision; provides that this Act, and any
land; and the judges in every state shal be bound thereby,
or the Amendments made by this Act shal be construed to
amendment made by it, would not: (1) alter jurisdiction
any thing in the Constitution or laws of any State to the
prohibit or limit—(1) any cause of action under State law;
between HHS and USDA under applicable statutes,
contrary notwithstanding." In general terms, federal
or (2) the introduction or evidence of compliance or
regulations, or agreements regarding products eligible for
preemption occurs when a validly enacted federal law
noncompliance with” the FFDCA.
voluntary inspection under the Agricultural Marketing Act
supersedes any inconsistent state law. Courts’ application
(7 U.S.C. 1621 et seq.); (2) alter the jurisdiction between
Also clarifies that nothing in this Act is to limit or
of this may involve such factors as whether or not a federal
the Administration of the Alcohol and Tobacco Tax and
otherwise alter the current jurisdiction or authorities
statute has explicitly stated Congress’ intent on the matter.
Trade Bureau and the HHS Secretary; (3) limit the
between the Secretaries of HHS and of Agriculture,
This issue is discussed regarding medical devices in CRS
authority of the HHS or Agriculture Secretary under
including those under the FFDCA, Public Health Service
Report R40534, Riegel v. Medtronic, Inc.: Federal Preemption
specified existing statutes (including the FFDCA); or (4)
Act, the Federal Meat Inspection Act (FMIA), the PPIA, or
of State Tort Law Regarding Medical Devices with FDA
impede, minimize, or affect the authority of the Secretary
the Egg Products Inspection Act (EPIA).
Premarket Approval.
of Homeland Security under the Homeland Security Act (6
USDA Exemptions (§ 5)
U.S.C. 101 et seq.).
Separately, FFDCA § 902(b) general y exempts meat and
meat food products from the provisions of the FFDCA; §
Explicitly exempts from this Act foods and establishments
24 of the Poultry Products Inspection Act (PPIA) general y
to the extent that they are regulated under the FMIA, PPIA,
exempts poultry and poultry products from FFDCA
or EPIA. Exempts a farm “to the extent such farm raises
provisions.
animals from which” such foods are derived. Clarifies that
livestock and poultry intended for slaughter under the
FMIA, PPIA, as well as milk-producing cows, sheep, or goats
are exempt.
Alcohol
Alcohol-Related Facilities (§ 6)
Alcohol-Related Facilities (§ 116)
The Federal Alcohol Administration Act (27 U.S.C. 201 et
Similar to the Senate provision, except that it contains a
General y exempts from this Act (the Manager’s Amdt.)
seq.) provides for regulation of those engaged in the alcohol shorter list of provisions excepted from the exemption.
beverages and facilities that are primarily regulated under
beverage industry, and for the protection of consumers.
Notably, mandatory recal and administrative detention
the Alcohol Administration Act. Certain of the act’s
provisions are not excepted from the exemption.
provisions are excepted from this exemption, including
Therefore, they would not apply to alcohol-related
those related to registration, mandatory recall, and
beverages and facilities.
administrative detention, among others; these provisions
would apply to alcohol-related beverages and facilities.
CRS-52
Background, Applicable Current Law, and
Administration Statements
H.R. 2749 (House-passed)
S. 510 (Senate-passed)
Extraterritorial Jurisdiction (§ 213)
Compliance With International Agreements (§ 404)
Makes the following a prohibited act under the FFDCA:
Nothing in this Act shall be construed in a manner
“The production, manufacture, processing, preparation,
inconsistent with the agreement establishing the World
packaging, holding, or distribution of an adulterated or
Trade Organization or any other agreement or treaty to
misbranded food with the knowledge or intent that such
which the United States is a party.
article will be imported into the United States.”
Adds a new § 312 to the FFDCA stating that “There is
extraterritorial Federal jurisdiction over any violation of
this Act relating to any food if such article was intended for
import into the United States or if any act in furtherance of
the violation was committed in the United States.”
FOOD FACILITY REGISTRATION REQUIREMENTS (See also “Registration”, “Mitigating Effects on Small Business and Farming Operations” and “Paying for Food Safety with
User Fees” sections of this report.)
Some assert that registration requirements should be
Changes in Registration of Food Facilities (§ 101)
Registration of Food Facilities (§ 102)
strengthened so that FDA is notified when a firm moves,
undertakes a new food business, or changes product lines.
Amends FFDCA § 415 both to require facilities to register
Amends FFDCA § 415 to require biennial facility
Otherwise, the FDA’s records on what facilities are
annual y, by each December 31, and to pay an annual
registration, with an abbreviated process for registrants
manufacturing and marketing food are continual y out of
registration fee of $500. The Secretary is authorized to
whose information has not changed. Registrants are
date, it is argued. Others have argued that additional
suspend the registration of any facility for an FFDCA
required to provide additional contact information,
registration requirements would be needlessly intrusive and violation that could result in serious adverse health
including an e-mail address and, for foreign facilities, the
costly for the industry.
consequences or death to humans or animals. Where the
United States agent for the facility. Registrants must also
Secretary exercises this discretionary suspension authority,
provide an assurance that the Secretary will be permitted
Both domestic and foreign food facilities are required to
the Secretary must first provide the facility a notice of
to inspect the facility. The Secretary is authorized or
register with FDA pursuant to FFDCA § 415. Farms,
intent and opportunity for an informal hearing, after which
required to suspend and/or reinstate registrations, based
restaurants, other retail food establishments, and most
a suspension order may be written for finding a violation,
on the Secretary’s determination that “food manufactured,
nonprofit food establishments and fishing vessels are
with timelines for doing so specified. A suspended
processed, packed, or held by a facility registered under
excluded from the requirement. Renewal is not required on registration could be reinstated based on criteria published
this section has a reasonable probability of causing serious
any periodic basis, but registrants must notify the Secretary
by the Secretary. Places limitations on the Secretary’s
adverse health consequences or death to humans or
in a timely manner of any relevant changes in their status.
authority to delegate suspension decisions.
animals” for a facility that “created, caused, or was
FFDCA § 301(dd) designates failure to register as a
otherwise responsible” or “that knew of, or had reason to
prohibited act. FFDCA § 801(l) provides that imported
Makes failure to register an act of “misbranding” under
know of, such reasonable probability.” The bill delineates an
food may not be delivered to the importer, owner, or
FFDCA § 403.
appeal process, including a requirement for an informal
consignee of the article until the foreign facility is
Also amends the information requirements of registrants to hearing generally within two business days, and procedures
registered. FDA does not have explicit authority to require
include: the name, address, and emergency contact of each
for submission of a corrective action plan and for lifting a
a registration fee.
facility being registered; its primary purpose and business
suspension. The Secretary shal review corrective action
plans “not later than 14 days after the submission” of such
Obama Administration: The Hamburg and Taylor
activity, including dates of operation if seasonal; the
plans. The Secretary also shall promulgate regulations
testimonies express support for § 101 of the House bill.
category of food manufactured, processed, packed or held
there; all business trade names; and the name, address and
regarding suspension and reinstatement procedures. If its
24-hour emergency contact information of the U.S.
registration is suspended, a facility may not import food, or
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S. 510 (Senate-passed)
distribution agent. Further requires registrants to notify the introduce food into interstate or intrastate commerce, in
Secretary of any changes in products, function or legal
the United States. The Secretary’s authority to suspend
status within 30 days of a change, unless otherwise specified registration shall not be delegated to anyone other than the
by the Secretary, who may cancel a registration that is
FDA Commissioner. The Secretary may require that
improperly updated or contains false, misleading, or
registration be submitted electronically, but not earlier than
inaccurate information, or if the required fee is not paid
5 years after enactment.
within 30 days.
Contains provisions for consideration of smal businesses.
Contains extensive language defining what is and is not a
Requires the Secretary to issue a ”small entity compliance
facility. A facility is “any factory, warehouse, or
policy guide” setting forth the requirements of such
establishment (including a factory, warehouse or
regulations to assist small entities in complying with the
establishment of an importer) that manufactures, processes, registration requirements and other activities (no later than
packs or holds food.” Stipulates that a facility is not a farm,
180 days after the issuance of the regulations under this
a private residence, a restaurant or other retail food
section).
establishment, a nonprofit establishment that prepares or
serves food directly, or a fishing vessel, and further clarifies
Requires the Secretary to amend the definition of “retail
what is meant by these exceptions. Also specifies what a
food establishment” (21 CFR 1.227(b)(11)) to clarify that, in
farm may or may not do to be exempted from facility
determining the primary function of such an establishment,
registration requirements.
the sale of food directly to consumers would include sales
by a roadside stand or farmers’ market, sales through a
Clarifies that a “retail food establishment” includes an
community supported agriculture (CSA) program, or other
establishment that, as its primary function, “sells food
types of direct food sales as determined by the Secretary.
products (including those food products that it
manufactures, processes, packs, or holds) directly to
consumers (including by Internet or mail order),” and also
includes grocery stores, convenience stores, vending
machine locations, and stores that sell bagged feed, pet
food, and feed ingredients or additives over-the-counter
directly to consumers and final purchasers for their own
personal animals.
See also “Funding and Fees” and “Foreign Supplier
Verification” below regarding importer registration
requirements and fees.
HAZARD PREVENTION PLANS (See also “Hazard Analysis and Risk-Based Preventive Controls”, “Mitigating Effects on Small Business and Farming Operations”, and “Mandatory
Recall Authority” sections of this report.)
A broad consensus of policymakers agrees that FDA’s
Hazard Analysis, Risk-Based Preventive Controls,
Hazard Analysis and Risk-Based Preventive
system of safeguards, which is based on a law first written
Food Safety Plan, Finished Product Test Results
Controls (§ 103)
early the last century, is primarily reactive. By and large, the from Category 1 Facilities (§ 102)
agency's statute and regulations spell out the reasons a food
Establishes a new FFDCA § 418, requiring the owner,
article is to be considered adulterated or misbranded and
Establishes a new FFDCA § 418, with provisions broadly
operator, or agent in charge of a facility to develop a
similar to those in S. 510, but differing somewhat in detail
written plan and carry out certain preventive activities in
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S. 510 (Senate-passed)
therefore unfit for consumption. In effect, industry players
and organization. Like S. 510, requires the owner, operator, the plan, including:
are expected to abide by the rules; generally it is only when or agent of a facility to analyze hazards and implement
a problem is detected—often after an illness outbreak is
controls to prevent or reduce them, but unlike S. 510,
• conducting an analysis to identify and evaluate known or
reported or testing finds a contaminant in a product—that
requires a food safety plan to be developed and
reasonably foreseeable hazards that may be associated with
officials step in to correct it, or order the industry to do.
implemented before a facility introduces or delivers for
the facility, hazards that may be intentionally introduced,
So virtually all stakeholders, including regulators, the
introduction into interstate commerce any shipment of
including by acts of terrorism; and preparing a written
regulated industries, consumer advocates, and food safety
food.
analysis;
scientists now agree that the foundations of any new
• identifying and implementing preventive controls,
program should be an understanding of what, and how,
Requires (under § 418A) that this plan include a hazard
including at critical control points, if any, to provide
hazards can enter the food supply, fol owed by
analysis to identify whether there are hazards, including
assurances that identified hazards will be prevented or
implementation of measures to prevent these hazards.
those due to the source of ingredients, that are reasonably
likely to occur in the absence of preventive controls. The
minimized, and that food is not adulterated or misbranded;
FDA currently requires that managers of certain food
plan also must include descriptions of:
• developing a means to verify the effectiveness of these
facilities—those producing or processing seafood, some
preventive controls;
juices, and low-acid canned foods—prepare Hazard
• preventive controls being implemented including those
Analysis and Critical Control Point (HACCP) plans for their to address hazards identified by the Secretary;
• implementing corrective actions if controls are found,
operations. HACCP is a preventive approach that
• procedures for monitoring preventive controls;
through monitoring, not to have been effective (specifies
incorporates hazard analysis, appropriate process controls,
that corrective actions ensure “(1) appropriate action is
verification, and other steps throughout the production
• procedures for taking corrective actions;
taken to reduce the likelihood of recurrence of the
process. A cornerstone of HACCP is the identification of
implementation failure; (2) all affected food is evaluated for
• verification activities including validation that such
hazards by industry that are “reasonably likely to occur.”
safety; and (3) al affected food is prevented from entering
controls are effective (to include use of environmental and
The emphasis on hazards that are reasonably likely to occur
into commerce if the owner, operator or agent in charge of
product testing programs);
assures that such hazards—such as microbial contamination
such facility cannot ensure that the affected food is not
in fresh juices, or botulism in low-acid canned foods—are
• monitoring of such preventive controls to verify
adulterated,” as defined by law)
systematically and consistently addressed.
effectiveness;
• verifying that preventive controls are effective, that
There is no explicit statutory authority or requirement
• record keeping procedures (records must be kept for at
monitoring is ongoing, that corrective actions are taken
regarding HACCP systems for FDA-regulated foods. FDA
least two years);
when needed, and that the plan is periodically reviewed for
regulations requiring HACCP plans and systems for
continued relevance;
• both established recall procedures and traceback
seafood, fruit and vegetable juices, and low-acid canned
procedures;
• keeping and maintaining, for at least two years, records
foods cite the applicable statutory authority as FFDCA §
documenting the monitoring of preventive controls,
402(a), which defines adulteration, and the Secretary’s
• procedures to ensure the safety of the supply chain for
relevant instances of nonconformance, instances when
general authority to promulgate regulations to assure the
ingredients;
corrective actions were implemented, and the efficacy of
safety of foods, at FFDCA § 701(a).
• procedures to implement performance standards issued
preventive controls and corrective actions.
At the U.S. Department of Agriculture, the Food Safety and by the Secretary (under a new FFDCA § 419).
Applicable definitions are provided in this section for
Inspection Service (FSIS) in 1996 began implementing rules
“critical control point,” “facility,” and “preventive controls.”
to establish a mandatory HACCP for meat and poultry,
The owner, operator, or agent must conduct a reanalysis of The required plan and associated documentation of
using its authority to regulate major meat and poultry
hazards (and revise preventive controls if necessary): (1) at
performance must be made promptly available to an
species under the Federal Meat Inspection Act (FMIA) and
least every two years (S. 510 is every three years); (2) if
authorized representative of the Secretary upon oral or
Poultry Products Inspection Act (PPIA). Record keeping
there is a change in the process or product that could
written request. The hazards must be reanalyzed at least
and verification are used to ensure that the system is
affect the hazard analysis; and (3) if the Secretary
every three years, or sooner if there is a change in
working. Following a phase-in period to accommodate
determines it is appropriate to protect public health. Limits
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S. 510 (Senate-passed)
smal er sized establishments, and since January 2000, al
the Secretary’s ability to delegate the authority to order
processes or practices that could create or worsen a
slaughter and processing operations have been required to
revisions. Contains applicable definitions (including one not
hazard. The Secretary may require a revision of the plan
have HACCP plans in place. HACCP is intended to operate in S. 510 defining “hazard that is reasonably likely to
based on a new hazard or new scientific information,
as an adjunct to the traditional methods of facility
occur”), the same deemed compliance for seafood, juice,
including, as appropriate, “results from the Department of
inspection, which still are mandatory under the original
and low-acid canning facilities, and the same effective dates
Homeland Security biological, chemical, radiological, or
statutes.
based on business size as in S. 510.
other terrorism risk assessment.” Failure to comply with
the requirements of this section is prohibited under
Obama Administration: The Administration's Food Safety
Also as is similar in S. 510, the Secretary is required to
FFDCA § 301.
Working Group (FSWG) stated that the Administration would issue guidance or regulations on standards for conducting a
work with Congress on “critical legislation that will provide
hazard analysis and establishing preventive controls.
Seafood, juice, and low-acid canned-food facilities that are
key tools .... to keep food safe.” One tool it cited was the
However, the Secretary must allow the facility to
already in compliance with applicable FDA regulations are
ability to require sanitation and preventive controls at food
implement an alternative preventive control if it is able to
deemed to be in compliance with this section. Facilities
facilities, based on a scientific hazard analysis. The Hamburg and demonstrate that it effectively addresses the hazard. Food
subject to requirements in FFDCA § 419, as established by
Taylor testimonies express support for § 102 of the House bill.
from facilities not in compliance with these provisions are
this act (regarding safety standards for produce), are not
to be considered adulterated under the FFDCA.
subject to this section. The Secretary may, by regulation,
exempt or modify the requirements of this section for
In issuing guidance or regulations, the Secretary must, to
facilities that are solely engaged in the production of food
seek consistency, review relevant international standards
for animals other than man, the storage of raw agricultural
for hazard analysis and preventive controls. The Secretary
commodities (other than fruits and vegetables) intended for
also must consider their impact on small businesses and
further distribution or processing, or the storage of
must issue guidance to assist smal businesses in complying.
packaged foods that are not exposed to the environment.
The Secretary is authorized to exempt from or modify, by
This section does not limit the Secretary’s authority to
regulation, the requirements with respect to facilities
revise, issue or enforce regulations for specific types of
engaged solely in the production of food for nonhumans
foods, such as the HACCP regulations currently in effect
(and may take into account differences between human and
for certain foods. This section does not apply to dietary
animal foods), facilities that store packaged foods not
supplements.
exposed to the environment, or facilities that store raw
Considering existing regulatory hazard analysis and
agricultural commodities for further distribution or
preventive control programs to determine applicable
processing.
internationally recognized standards, the Secretary shall
Further, under a new FFDCA § 418B, the Secretary must
promulgate regulations not later than 18 months after
require submission of finished product test results by the
enactment regarding the implementation of requirements
owner, operator, or agent of each category 1 facility (see
under this section, and shall issue an applicable guidance
“Risk-Based Inspection Schedule,” below, for definition of
document. Regulations shall be sufficiently flexible to be
such facility) “...documenting the presence of contaminants
applicable in all situations, including the operations of small
in food in the possession or control of such facility posing a
businesses. This section does not provide the Secretary
risk of severe adverse health consequences or death.” Such
with the authority to apply specific technologies, practices,
submissions are those determined by the Secretary to be
or critical controls to an individual facility.
feasible and appropriate and taking into consideration
Contains clarifying language regarding the promulgation of
available information on potential risks; and this section is
FDA regulations, including consideration for various types
not to: construe a requirement for mandated “testing or
of businesses and activities (on-farm and at processing
submission of test results that the Secretary determines
facilities). Contains provisions for consideration of small
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S. 510 (Senate-passed)
would not provide useful information in assessing the
businesses. Requires the Secretary to issue a ”smal entity
potential risk presented by a facility or product category”;
compliance policy guide” setting forth the requirements of
or to limit the Secretary’s authority under other provisions
such regulations to assist small entities in complying with
to access information or test results including in the course
the registration requirements and other activities (no later
of an investigation of an illness or contamination incident.
than 180 days after the issuance of the regulations under
this section), along with other flexibility and extended
This requirement is to take effect on the sooner of either 2 implementation deadlines for small and very small
years from date of enactment or the completion of a
businesses. Requirements become effective in stages
feasibility study and at least two pilot projects that are
according to the size of the business: businesses must be
required. Food from a facility not in compliance with the
compliant 18 months after the date of enactment, except
requirements of new § 418B is adulterated.
smal businesses (as defined by the Secretary) are to have 2
years after enactment, and very smal businesses (as defined
by the Secretary) 3 years after enactment.
Under added language in S. Amdt. 4715 certain facilities
would not be subject to the requirements. Food facilities
would qualify for an exemption from the HACCP
requirements if they are either a “very small business” as
defined by FDA in rulemaking, or if the facility’s “average
annual monetary value” of al food sold during the previous
3 year period was less than $500,000, provided that the
food is sold directly to “qualified end users” such as
consumers, restaurants, or retail food establishments that
are located in the same state where the facility sold the
food or within 275 miles of the facility. Such a facility would
need to demonstrate that it either has “identified potential
hazards associated with the food being produced,” and is
implementing and monitoring these preventive controls, or
that it is “in compliance with State, local, county, or other
applicable non-Federal food safety law.” Foods produced
from such a facility would also need to provide the facility’s
name and address on a food packaging label or at the point
of purchase. Requires FDA to conduct a study of the food
processing sector, in conjunction with USDA.
PERFORMANCE STANDARDS (See also “Performance Standards” section of this report.)
Performance standards are typically specific, quantitative
Performance Standards (§ 103)
Performance Standards (§ 104)
measurements of a property of, or a substance in, food.
They may apply strictly to the property being measured, or
Similar in intent but not identical to S. 510. Under a new
In coordination with USDA, the Secretary shall, at least
serve as benchmarks for whether the food is safe in a
FFDCA § 419, the Secretary must at least every two years
every two years, review and evaluate relevant health data
broader sense. For example, a performance standard for a
review and evaluate epidemiological data and other
and other relevant information, including epidemiological
appropriate information, including research under § 123
and toxicological data and other appropriate information to
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S. 510 (Senate-passed)
single microbe might be used to determine whether a
(the research section) of the bill, to identify the most
determine the most significant foodborne contaminants.
product is contaminated with microbes in general. (This
significant food-borne contaminants and resulting hazards.
approach is sometimes cal ed process verification.) Such a
Following each review, the Secretary must publish in the
Based on such review and evaluation and when appropriate
finding could indicate a problem with the product’s
Federal Register a list of contaminants that have the
to reduce the risk of serious illness or death to humans or
processing, and prompt a review of processing activities.
greatest adverse impact on public health (and must
animals, or to prevent the adulteration of the food under
The FFDCA (in various provisions in Chapter IV, regarding
consider the number and severity of illnesses and deaths
FFDCA § 402 or the spread of communicable disease under
food) authorizes FDA to promulgate standards for certain
associated with the contaminant in a food).
PHS Act § 361, the Secretary shall issue contaminant-
hazards, such as maximum permissible levels (cal ed
specific and science-based guidance documents, actions
tolerances) for residues of pesticides or drugs in foods. The The Secretary must issue, “as soon as practicable” through
levels, or regulations. Such standards shall apply to
FFDCA does not grant FDA the explicit authority to
guidance or by regulation, science-based performance
products and product classes, may differentiate between
develop standards solely as a means to verify that
standards (which may include action levels) to significantly
food for humans and food for animals, and shall not be
processing is carried out in a manner that assures the safety minimize, prevent, or eliminate such hazards. The standards written to be facility-specific. HHS shall coordinate with
of the food.
shal apply to foods and food classes. Foods not meeting
USDA to avoid duplication of effort regarding guidance
required standards are to be considered adulterated. The
documents for the same contaminant. The Secretary will
Obama Administration: The FSWG stated that the
Secretary is authorized to make recommendations to
issue and periodically review/revise all guidance documents
Administration would work with Congress on “critical
industry on product sampling. Finally, the Secretary must
and regulation.
legislation that will provide key tools .... to keep food safe.”
report to Congress on the review including how the
One tool it cited was the ability to establish performance
Secretary will address significant hazards and any resource
standards to measure the implementation of proper food
or data limitations that preclude further action.
safety standards. The Hamburg and Taylor testimonies
express support for § 103 of the House bill.
PRODUCE SAFETY STANDARDS (See also “On-Farm Safety Standards; Safety of Produce” and “Mitigating Effects on Small Business and Farming Operations” sections of this
report.)
As noted earlier, the FFDCA authorizes FDA to
Safety Standards for Produce and Certain Other
Standards for Produce Safety (§ 105)
promulgate standards for certain hazards, some of which,
Raw Agricultural Commodities (§ 104)
such as maximum permissible levels (called tolerances) for
Subsection (a) of this section establishes a new FFDCA §
residues of pesticides, may apply to produce. The FFDCA
Under a new FFDCA § 419A, within 18 months of
419, regarding safety standards for produce. Within one
does not grant FDA explicit authority to develop standards
enactment, the Secretary (in coordination with the
year of enactment, the Secretary (in consultation with
solely as a means to verify that processing is carried out in
Secretary of Agriculture) must publish a notice of proposed USDA and state agriculture departments, including with
a manner that assures the safety of the food. FDA has
rulemaking, and within three years after such date, final
regard to the national organic foods program, and in
several voluntary efforts in place to address safety in the
rules establishing scientific and risk-based standards for the
consultation with DHS), is required to publish a notice of
produce industry. For example, in February 2008, the
safe growing, harvesting, processing, packing, sorting,
proposed rulemaking for science-based minimum standards
agency issued the final version of the Guide to Minimize
transporting, and holding of those types of raw agricultural
for the safe production and harvesting of those fruits and
Microbial Food Safety Hazards of Fresh-cut Fruits and
commodities that are from a fruit, vegetable, nut, or fungus, vegetables that are raw agricultural commodities (including
Vegetables, which contains non-binding recommendations
and for which the Secretary has determined such standards
mixes and specific categories of fruits and vegetables), for
regarding: primary production and harvesting of fresh fruits
are reasonably necessary to minimize the risk of serious
which the Secretary has determined that such standards
and vegetables; personnel; buildings and equipment;
adverse health consequences or death to humans or
minimize the risk of serious adverse health consequences
sanitation operations; production and process controls;
animals
or death. The Secretary may exclude from such rulemaking
documentation and records; traceback; and recall. On
commodities determined to be low risk when produced or
These regulations may set forth procedures and practices
September 2, 2008, FDA published a notice in the Federal
harvested by smal or very smal businesses. The Secretary
that the Secretary determines reasonable to prevent
shall hold at least 3 public meetings on such rulemaking in
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Register seeking comments and data to assist the agency in
known or reasonably foreseeable biological, chemical, and
diverse geographic areas.
its revision, now underway, of its 1998 Guide to Minimize
physical hazards, including natural ones, that may be
Microbial Food Safety Hazards for Fresh Fruits and
intentionally or unintentionally introduced. The regulations
Proposed rulemaking shall “provide sufficient flexibility to
Vegetables. Also, FDA asserts that it has been engaged in
may include minimum safety standards, and address manure be applicable to various types of entities…including smal
efforts to identify hazards commonly associated with fresh
use, water quality, employee hygiene, sanitation and animal
businesses and entities that sel directly to consumers, and
produce, and to develop tracking and tracing methods.
control, and temperature controls, as the Secretary
be appropriate to the scale and diversity” of production
determines to be reasonably necessary. They may provide
and harvesting. The proposed rule also shall address
Under the Agricultural Marketing Agreement Act of 1937
for coordination of education and enforcement activities
minimum standards for other specified elements, including
(7 U.S.C. § 601 et seq.), producers and handlers can
and must provide a reasonable time for compliance, taking
soil amendments, hygiene, packaging, temperature controls,
organize themselves under legally binding marketing orders
into account the needs of smal businesses for additional
animal encroachment and water, as well as hazards that
that can include quality (and possibly, safety) standards. The
time, among other permitted activities. The Secretary is
occur naturally or that may have been introduced,
act is overseen by USDA’s Agricultural Marketing Service
required to take into consideration (consistent with public
intentionally or unintentionally. The proposal shall take into
(AMS). In an advance notice of proposed rulemaking, AMS
health) “the impact on small-scale and diversified farms, and consideration, consistent with public health protection,
in October 2007 invited comments on whether to create
on wildlife habitat, conservation practices, watershed-
“conservation and environmental practice standards and
such a federal marketing program that specifically would
protection efforts, and organic production methods.” The
policies established by Federal natural resource
require handlers (packers, processors, shippers) of leafy
Secretary shal coordinate with the Secretary of Agriculture conservation, wildlife conservation, and environmental
greens, including lettuce and spinach, to meet prescribed
and may contract and coordinate with a Governor-
agencies,” and also “in the case of production that is
safety standards. A similar state order was adopted by
designated state agency for education and compliance
certified organic, not include any requirements that conflict
California growers in 2006.
activities (emphasis added to distinguish from S. 510, which
with or duplicate the requirements of” the national organic
foods program, while providing the same level of
Obama Administration: The FSWG announced, and
mandates use of state agencies).
protection as required under this act. Priority is to be given
FDA issued on July 31, 2009, new draft guidances on three
Under this new provision, a food is adulterated if it is
to those raw fruits and vegetables that have been
specific types of produce: Guide to Minimize Microbial
grown, harvested, packed, sorted, transported or held
associated with food-borne illness outbreaks.
Food Safety Hazards of Tomatoes, Guide to Minimize
under conditions that do not meet these new
Microbial Food Safety Hazards of Melons, and Guide to
requirements. The bill appears to lack the variance
Subsection (b) states that within a year of the closing of the
Minimize Microbial Food Safety Hazards of Leafy Greens,
procedures, and the express exemption for those required
comment period, the Secretary shall adopt a final rule to
which, when finalized (and as is the case for all FDA
to meet hazard analysis and prevention standards that are
provide for minimum standards for certain types of fruits
guidance documents), will be nonbinding and will represent
in S. 510.
and vegetables, as needed to minimize the risk of serious
FDA’s current thinking on these topics.
adverse health consequences. Among other requirements,
Requires the Secretary to update the 1998 guidance for
the final rule shall provide for coordination of education
Also, the Hamburg and Taylor testimonies express support
minimizing hazards in fresh fruits and vegetables.
and enforcement activities with state and local officials,
for § 104 of the House bill.
minimize recordkeeping burdens, and describe the variance
process and the types of permissible variances that the
Secretary may grant to states and foreign countries to
address local growing conditions. Effective dates for
compliance are phased in for small and very small business
(see below). The Secretary may coordinate with USDA and
shal contract as appropriate with states to conduct
compliance activities (emphasis added). Not later than one
year after enactment, the Secretary shal publish updated
good agricultural practices and guidance for the safe
production and harvesting of specific types of produce,
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after consultation with stakeholders (as specified). This
section shall not apply to facilities subject to FFDCA § 418
(Hazard Analysis and Risk-based Preventive Controls), as
established by this act.
Failure to comply with requirements under this section is
prohibited. Amendments made by this section do not limit
the authority of the Secretary under the FFDCA or the
Public Health Service (PHS) Act [42 U.S.C. § 201 et seq.] to
revise, issue, or enforce product and category-specific
regulations, such as those for existing HACCP programs.
This section contains provisions for consideration of small
businesses. As noted above, smal and very smal businesses
may be exempted from regulation if the Secretary has
determined these “are low risk and do not present a risk of
serious adverse health consequences or death.” Extended
implementation deadlines for small and very small
businesses apply: smal businesses (as defined by the
Secretary) are to have 1 year after final regulation are
promulgated, and very smal businesses (as defined by the
Secretary) 2 years after final regulations. Requires the
Secretary to issue a ”small entity compliance policy guide”
setting forth the requirements of such regulations to assist
small entities in complying with the registration
requirements and other activities (no later than 180 days
after the issuance of the regulations under this section),
along with other flexibility for small businesses. Requires
the Secretary to ensure any updated guidance comply with
the Paperwork Reduction Act (PRA) and minimize
regulatory burden and unnecessary paperwork and the
number of separate standards on the facility, among other
clarification regarding acknowledgment of risk differences
and compliance burden.
Under added language in S. Amdt. 4715 certain farms
would not be subject to the requirements. Farms would
qualify for an exemption from the HACCP requirements if
the farm’s “average annual monetary value” of al food sold
during the previous 3 year period was less than $500,000,
provided that the food is sold directly to “qualified end
users” such as consumers, restaurants, or retail food
establishments that are located in the same state where the
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S. 510 (Senate-passed)
facility sold the food or within 275 miles of the facility.
Foods produced from such a farm would also need to
provide the farm’s name and address on a food packaging
label or at the point of purchase. Such a farm would also
need to be in compliance with State, local, county, or other
applicable non-Federal food safety laws. Foods produced
from such a farm would also need to provide the facility’s
name and address on a food packaging label or at the point
of purchase.
INSPECTION OF FACILITIES (See also “Targeting of Inspections” and “Mandatory Recall Authority” sections of this report, and “Inspection of Foreign Facilities” row of this table.)
Reform advocates argue that many of the recent problems
Risk-Based Inspection Schedule (§ 105)
Targeting of Inspection Resources for Domestic
that have led to illness outbreaks and recalls might have
Facilities, Foreign Facilities, and Ports of Entry;
been avoided if inspectors were more frequently present in
Amends § 704 (Inspection, in the General Authority
Annual Report (§ 201)
plants to monitor sanitary conditions and processes. Due
chapter of the FFDCA) to require each § 415-registered
to the differing laws and circumstances that apply to FSIS,
facility to be inspected randomly by officers duly designated
Subsection (a) of this section establishes a new FFDCA §
for example, that agency’s inspectors are in meat and
by the Secretary at a frequency based on the risk of the
421 (in the food chapter of the FFDCA), requiring the
poultry slaughter and processing plants every day, where
facility. The Secretary may use federal, state, or local
Secretary, with respect to facilities that must register under
they must organoleptically (by the senses) examine every
officials for domestic inspections and foreign country
FFDCA § 415, to al ocate inspection resources according to
live animal and every carcass for defects, and must pass
representatives for foreign ones. The inspection schedule
the “known safety risks” of the food and countries
every item before it can enter commerce.
must be implemented within 18 months of enactment and
involved, as well as the facility’s compliance history, the
follow these prescribed categories and frequencies:
rigor of its hazard analysis and risk-based preventive
Current law, which derives from FFDCA § 704 (in the
controls, among other stated criteria. Establishes separate
General Authority chapter of the FFDCA), authorizes but
• Category 1, a high-risk food facility that manufactures or
inspection frequencies and increasing frequency rates for
does not require FDA to inspect food facilities. Therefore,
processes food, must be inspected at least every 6-12
domestic and foreign facilities for both high-risk and non-
no periodic inspection frequency is currently required.
months;
high-risk entities. Establishes requirements for identification
and inspection at ports for imported foods, including
Obama Administration: The FSWG stated that the
• Category 2, a low-risk facility that manufactures or
consideration of whether the shipment has been certified
Administration would work with Congress on “critical
processes food or a facility that packs or labels food, must
under a voluntary qualified importer program or other
legislation that will provide key tools .... to keep food safe.”
be inspected at least every 18 months to 3 years;
criteria.
One tool it cited was “the ability to use resources flexibly
• Category 3, a food facility that holds food, must be
to target food at the highest risk and achieve the maximum
inspected at least every 5 years.
The Secretary shall improve coordination and cooperation
gain for public health.” However, Dr. Hamburg’s testimony
with the Secretaries of Agriculture and Homeland Security
noted several issues regarding § 105 of the House bill (as
Authorizes the Secretary to modify the types of food
to target food inspection resources. It also authorizes
introduced prior to subcommittee markup), including both
facilities within each category, to alter inspection
interagency agreements regarding seafood (involving HHS,
the large amount of resources needed to meet the
frequencies if needed to respond to illness outbreaks and
DHS, Commerce Department, and the Federal Trade
inspection goals in the bill and the difficulty of hiring and
recalls, and to inspect a facility more frequently than
Commission, among other agencies); such agreements may
training the additional staff that would be needed. She
specified. In doing so, the Secretary is to consider the type
include examining and testing seafood imports, coordinating
recommended modification “to take into account the
of food at the facility, its compliance history, whether an
inspections of foreign facilities, standardizing data, among
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operational challenges involved, such as by changing these
importing facility is certified (under the new certification
others. Provides for advisory committee consultation
inspection frequencies .... flexibility to modify the inspection requirements the bill would set; see below), and other
within HHS with respect to allocating inspection resources.
requirements based on the best available data on risk,”
factors determined relevant by the Secretary. The
among other things. In his subsequent testimony on the
Secretary is authorized to publish in the Federal Register
Subsection (b) of this section requires the Secretary to
House committee-approved bill, Mr. Taylor expressed
adjustments to inspection frequencies in category 2 and 3
report to Congress, by February 1 of each year, providing
support for its flexibility to adjust inspection frequencies.
facilities, and is required to publish in the Federal Register
specified information regarding: domestic and foreign food
any proposed modifications of the categorization of any
facility inspections (including those scheduled but not
facility or facility type. The Secretary must submit an annual
completed); food imports; and FDA foreign offices. Such
report on the inspections to Congress, which is to include
reports shal be made publicly available.
numbers inspected and cost estimates, and also to submit a
3-year report on any needed adjustments to the risk-based
inspection schedule. These recommendations must
consider a number of factors listed in this section such as
the nature of the food product and how it is handled; its
association with food-borne illnesses, and others.
RECORDKEEPING REQUIREMENTS AND FDA ACCESS TO RECORDS (See also “Record-Keeping” and “Mitigating Effects on Small Business and Farming Operations”
sections of this report.)
Many advocates of reform argue that recordkeeping
Access to Records (§ 106)
Inspections of Records (§ 101)
requirements must be strengthened to improve the ability
Broader than S. 510; amends FFDCA § 414(a) regarding
of regulators to determine whether firms are complying
Amends FFDCA § 414, which contains one standard
Records Inspection. Although much of the amended
with the law and to facilitate efforts to find the source of
(trigger) for records access, by creating two such standards.
language appears similar to existing language, several
problems (including during product recal s) when they do
The first is somewhat similar to current law by authorizing
qualifying phrases are now absent. For example, the bill
occur. One of their concerns has been that records are not
access “If the Secretary has a reasonable belief that an
broadens the ability to access records by deleting the
required to be maintained in electronic format, which if
article of food and any other article of food that the
following conditional phrase in the current law: “If the
required, these advocates assert, would greatly speed
Secretary reasonably believes is likely to be affected in a
Secretary has a reasonable belief that an article of food is
outbreak response. Related issues include the types of
similar manner is adulterated and presents a threat of
adulterated and presents a threat of serious adverse health
records to be kept, how detailed they should be, how long
serious adverse health consequences or death to humans
consequences or death to humans or animals...” (Drafters
they should be kept, and access and use of these records by
or animals...” The second standard authorizes access “If the
of the bill view this as new authority to access records
authorities. For example, are the current legal premises for
Secretary believes that there is a reasonable probability that
during routine inspections.) The bill also no longer requires
accessing records (see below), adequate? Proposals for
the use of or exposure to an article of food, and any other
that “written notice” be provided in advance of accessing
increased recordkeeping requirements often raise
article of food that the Secretary reasonably believes is
records. However, records not required to be immediately
questions about the intrusiveness of government, privacy
likely to be affected in a similar manner, will cause serious
concerns, and the protection of sensitive commercial
available at the start of a records inspection must be
adverse health consequences or death to humans or
information (trade secrets), for example.
immediately available if requested in advance by letter. Also, animals...” It appears that by invoking the second standard,
relevant records (i.e., for access and copying) are to be all
the Secretary would no longer be required to have a
FFDCA § 414 currently authorizes the Secretary, by
those “relating to such article bearing on whether the food
reasonable belief that a food is adulterated in order to have
regulation, to require that food establishments (except
is adulterated, misbranded, or otherwise in violation of this
access to records.
farms and restaurants) maintain certain records regarding
Act...” rather than the higher current threshold—which is
foods, including immediate previous sources, and immediate those records “needed to assist the Secretary in
Also apparently new under both standards would be the
subsequent recipients. “If the Secretary has a reasonable
determining whether a food is adulterated and presents a
ability to access records if “any other article of food” could
be similarly affected, such as food produced on the same
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belief that an article of food is adulterated and presents a
threat of serious adverse health consequences.”
manufacturing line as an implicated food, or food produced
threat of serious adverse health consequences or death to
New provisions spell out the conditions under which the
using implicated ingredients. Under either trigger, a
humans or animals,” such records must be made available
designee of the Secretary is to be granted access to records
for inspection and copying upon written notice. (Emphasis
Secretary could require remote access to records (i.e., not
appear at a facility to review them), notably where “...the
upon presentation of appropriate credentials and a written
added.) The Secretary is required to take appropriate
notice to such person, at reasonable times and within
measures to ensure that unauthorized disclosure of any
Secretary has reasonable belief that an article of food
reasonable limits and in a reasonable manner. Requirements
trade secret or confidential information is prevented.
presents a threat of serious adverse health consequences
or death to humans or animals.”
apply to al records relating to the manufacture, processing,
packing, distribution, receipt, holding, or importation of a
Obama Administration: The FSWG stated that the
Restaurants would be subject to some records access
food, in any format (including paper and electronic
Administration would work with Congress on “critical
requirements. However, the only distribution of records
formats), and at any location. No specific format is
legislation that will provide key tools .... to keep food safe.”
which may be required of restaurants under this subjection
required. Farms and restaurants would continue to be
One tool it cited was “the ability to access basic food safety are those showing the restaurant’s suppliers and
excluded under FFDCA § 414.
records at facilities.” The Hamburg and Taylor testimonies
subsequent distribution other than to consumers.
express support for § 106 of the House bill.
See also “Enhancing Tracking and Tracing of Food and
Also, states that access to records provisions do not apply
Recordkeeping” (§ 204)
to farms—except that a farm owner, operator, or agent
must permit an officer or employee of the Secretary to
have access to and copy al records relating to an article of
food that is produced, manufactured, processed, packed, or
held on the farm. This exception applies only if the article
of food either: is a fruit, vegetable, nut or fungus that is
subject to a standard under new § 419A (see Safety
Standards for Produce and Certain Other Raw Agricultural
Commodities, §104); or is the subject of an active
investigation by the Secretary of a foodborne illness
outbreak and is further not a grain or similarly handled
commodity (generally, the list in the bill encompasses the
row crops covered by USDA price supports).
Additional y for farms, that Secretary must as soon as
practicable (in coordination with the Secretary of
Agriculture) identify and issue guidance on one or more
fruits, vegetables, nuts, or fungi where access to records
will be used. This section also requires such identification
to be based on illness outbreaks, requires its expiration
when the new § 419A rules take effect, and requires the
Secretary to consult with the Secretary of Agriculture in
issuing regulations “with respect to farms under this
subsection and shal take into account the nature of and
impact on farms,” among other things.
(See also the records provisions in “Traceability of Food,” §
107, and “Registration for Customs Brokers,” § 205.)
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TRACEABILITY OF FOOD (See also “Mitigating Effects on Small Business and Farming Operations” and “Notification of Contaminated Products and Product Tracing” sections of
this report.)
Traceability means the ability to follow the movement of a
Traceability of Food (§ 107); Unique identification
Enhancing Tracking and Tracing of Food and
product through its stages of production and distribution.
number for food facilities, importers, and custom
Recordkeeping (§ 204)
As a food safety tool, traceability helps government
brokers (§ 206)
The Secretary, in coordination with USDA and state
authorities and industry officials to locate the source of
contamination (traceback) and to locate those who may
Amends FFDCA § 414 to require the Secretary to establish
officials, shall improve the capacity of FDA to effectively and
rapidly track and trace foods in the event of an outbreak.
have received the contaminated food (trace forward).
by regulation a tracing system for food in, or to be imported
Records sufficient to identify products and to trace them
into, the United States. These regulations are to enable the
Within 270 days of enactment, the Secretary is required to
establish pilot projects in coordination with the food
quickly are considered to be important prerequisites for a
Secretary “to identify each person who grows, produces,
successful recall. (see below.) Among other issues are the
manufactures, processes, packs, transports, holds, or sel s
industry to explore and evaluate methods to rapidly and
effectively identify recipients of food to prevent or mitigate
potential administrative and cost burdens that a more
such food in as short a timeframe as practicable but no
extensive regulatory program might impose on those in the
longer than 2 business days.” The Secretary is authorized to
a foodborne illness outbreak and to address credible
food system, as well as privacy concerns about records.
include in such regulations the use of lot numbers, a
threats of serious adverse health consequences or death
standardized format for pedigree information, and the use of
to humans or animals as a result of such food being
§ 306 of the Public Health Security and Bioterrorism
a common food nomenclature.
adulterated or misbranded.
Response Act of 2002 amended the FFDCA to require any
Participants are to include one or more projects with the
person who manufactures, processes, packs, transports,
However, before promulgating regulations the Secretary is
processed food sector and one or more projects
receives, holds or imports foods into the United States to
required to first identify tracing technologies and
coordinating processors or distributors of fruits and
keep records that enable the identification of the immediate methodologies that can enable each of the food industry
vegetables that are “raw agricultural commodities,”
previous supplier and the immediate subsequent recipient
sectors to: maintain the full pedigree of the food from source reflecting the diversity of the food supply and include at
of the food (FFDCA § 414; see also “Records Access and
through subsequent distribution; make traceback
least three different types of foods that have been the
Records Inspection,” above).
interoperable with other systems; and use a unique identifier
for each facility. Prior to proposing regulations, the
subject of significant outbreaks during the 5-year period
Obama Administration: In July 2009, the FSWG
Secretary also first must, to the extent practicable, assess
preceding enactment, among other criteria for project
announced a number of steps the Obama Administration
costs, benefits and feasibility of adopting such technologies;
selection intended to inform future rule promulgation. The
was taking, under existing authorities, to improve
conduct at least two public meetings; and conduct one or
Secretary shall report to Congress its findings for
traceability, including:
more pilots.
improving the tracking and tracing of food within 18
months of enactment.
• issue draft guidance on what industry could do to
The traceback regulations wil apply to agricultural producers
establish product tracing systems;
(and retailers), but the provision specifically exempts food
The Secretary, in coordination with USDA and state
that is produced on a farm or fishery (wild or farmed) and
departments of health and agriculture, shall collect
• require federal agencies are to implement a new
sold by that farm or fishery directly to a consumer,
additional data to assess product tracing technologies,
“incident command system to address outbreaks of
restaurant, or grocery store. However, such farms and
among other information. The Secretary, in consultation
foodborne illness;
fisheries must keep records for at least 6 months
with USDA, shall also establish within FDA a product
• increase FSIS capacity of its public health epidemiology
documenting the restaurants or grocery stores to which it
tracing system to receive information needed to track and
liaison program to State public health departments through
sold; and the restaurants and grocery stores are required to
trace food.
new hires and expanded outreach;
keep records documenting the farm source. The Secretary
The Secretary shal publish a notice of proposed rulemaking
may also exempt a food or a type of facility, farm, or
to establish additional recordkeeping requirements for
• ask State and local agencies to update their emergency
restaurant from the regulations, or modify the requirements
high-risk foods, subject to certain specified conditions (no
operations procedures to be consistent with new food
for these entities, if the Secretary “determines that a tracing
later than two years after enactment). The Secretary shal
disease outbreak guidelines being issued by the Council to
system for such food .. is not necessary to protect the public designate such high-risk foods within one year after
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Improve Foodborne Outbreak Response;
health.” For this latter category of exemptions, each person
enactment based on criteria specified in the provision, and
who produces, manufactures, processes, packs, transports,
shall publish the list of foods designated as high-risk, which
• improve col aboration between the CDC and the States
or holds such food stil must maintain records that identify
may be subject to updates and revision. The provision
to evaluate and optimize best practices for more effective
the immediate previous sources of the food and its
addresses information protection; requirements for public
outbreak investigations, and launch a new system to
ingredients and the immediate subsequent recipients.
input; rules on retention of records; and less restrictive
facilitate information-sharing and adoption of best practices.
requirements (as specified) for: farm-to-school or farm-to-
Contains language limiting applicability to farms, including
In its July 2010 progress report, the Administration
institution programs of USDA and other related programs;
requirements that the Secretary coordinate with the
announced that “FDA has conducted a pilot study on a
“identity-preserved labels” with respect to farm sales of
Secretary of Agriculture when conducting pilot projects with
tracing system, and HHS, in collaboration with USDA, has
food that is produced and packaged on a farm; food that is
respect to farms and when issuing regulations that will impact
rolled out an enhanced and updated www.foodsafety.gov
produced through the use of a fishing vessel; producers of
farms. Furthermore, any new tracing system with respect to
site to provide consumers rapid access to information on
commingled raw agricultural commodities; grocery stores;
grain or any “similarly handled commodities” (generally,
food recalls,” among other actions.
direct farm sales to consumers or grocery store; and
those row crops that have been covered by USDA price
others. The Secretary may modify requirements, or exempt
Also, the Hamburg and Taylor testimonies express support
supports) must be “limited to enabling the Secretary to
a food or facility from them, if product tracing
for § 107 of the House bill.
identify those who received, processed, packed, transported,
requirements are not needed to protect public health.
distributed, held, or sold” such a commodity “from the initial
warehouse operator that held” it “for any period of time to
The Secretary shall submit a report to Congress “taking
the ultimate consumer.”
into consideration the costs of compliance and other
regulatory burdens on small businesses, and federal, state,
and local food safety practices and requirements, that
evaluates the public health benefits and risks” of limiting the
product tracing requirements to certain identified foods
and also limiting the participation of restaurants in the
recordkeeping requirements.
The provision also specifies the information the Secretary
may request from U.S. farms, subject to certain limitations,
but specifies that the Secretary is not authorized to impose
any limitations on comingled foods. With the exception of
farms, failure to comply with recordkeeping provisions
under this section is prohibited.
This section contains provisions for consideration of small
businesses. Requires the Secretary to issue a ”smal entity
compliance policy guide” setting forth the requirements of
such regulations to assist small entities in complying with
the registration requirements and other activities (no later
than 180 days after the issuance of the regulations under
this section), along with phased-in compliance deadlines for
smal and very smal businesses. Smal businesses (as defined
by the Secretary) will have 1 year after final regulations are
promulgated, and very smal businesses (as defined by the
Secretary) 2 years after final regulations.
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FUNDING AND FEES (See also “Paying for Food Safety with User Fees” and “Mandatory Recall Authority” sections of this report.)
Many critics argue that—irrespective of the need, if any, to
Various Sections (§ 101, § 108, § 203, § 204)
Authority to Collect Fees (§ 107)
reform food safety statutes and organization—a
fundamental problem has been the lack of sufficient funding
Authority to assess new types of food-related fees appear
Authorizes FDA to col ect two types of fees related to
and staff to carry out congressional y mandated (and
in four sections of the House bill.
food: export certification fees and user fees. The export
existing) responsibilities to ensure a safe food supply.
certification provisions in current law are amended to allow
Under § 101, Changes in Registration of Food
food exporters to request that the Secretary certify that
Proposed increases in program spending raise a variety of
Facilities, the Secretary is required to assess and collect a
exported foods comply with provisions in the FFDCA, and
policy issues. Requests for higher appropriations always
facility registration fee each year from facilities required to
would thus enable the associated fee to be charged to the
compete with other priorities throughout the federal
register under FFDCA § 415. This fee is to be set at $500
exporter. The food user fees are established by inserting a
discretionary budget (the programs do not operate, like
per facility in FY2010; for FY2011 and each subsequent
new FFDCA § 743 : “Part 6–Fees Related to Food.” The
farm support programs, for example, as mandatory
fiscal year, the fee is to be adjusted to reflect the cost of
new part authorizes, indefinitely, the assessment and
authorizations). Such requests currently are being made
inflation, under a specified formula. § 101 also sets a
collection of four user fees:
during a period of huge budget deficits. Efforts to fill
maximum annual fee payment of $175,000 for those who
perceived shortfal s through new fees on the food industry
have multiple facilities. Other provisions in this section:
• fees paid by domestic facilities subject to a reinspection
always meet with resistance, both from the companies that
require the Secretary to hold a public meeting each fiscal
(to cover reinspection-related costs);
would have to absorb such costs, and from consumer
year to explain the fees’ use and to solicit stakeholder
• fees paid by domestic facilities and importers subject to
advocates, who have long argued that industry funds might
views; are intended to ensure that these fees do not
food recal s (to cover food recal activities performed by
compromise public health programs.
supplant FDA appropriations or reduce HHS Department
staffing; address their collection, crediting and availability vis the Secretary);
Congressional appropriators have steadily increased funding a vis appropriations; sunset the fees after FY2014; and
• fees paid by importers participating in the voluntary
for FDA food activities in recent years: from about $440
require annual reports to Congress. “Food safety activities” qualified importer program (to cover administrative costs
million FY2005 and FY2006; $510 million in FY2008; $710
and “costs of food safety activities” are extensively defined
of the program); and
million in FY2009; and $780 million in FY2010. $1.04 billion
in this section. The provisions in this section are modeled
was requested for FY2011.
in part on existing user fee authorities for drugs and
• fees paid by importers subject to reinspection (to cover
devices.
reinspection-related costs).
In general, FDA’s fee-funded programs for drugs and
devices have finite appropriations authorities that sunset,
Under § 108, Reinspection and Food Recall Fees
Overdue fees are treated as claims of the United States
prohibiting the agency from collecting fees beyond the
Applicable to Facilities, the Secretary is required to
Government under 21 U.S.C. § 37. The Secretary is
authorized time frame. These authorities do not apply to
assess and collect a fee from each facility that either:
required to report annual y to Congress describing the
food safety programs at this time. In addition, some
violates any food-related requirement of the FFDCA and
entities paying fees, and the fees assessed and collected for
discretionary-funded grant programs have finite
therefore must undergo additional FDA inspection; or is
each year.
appropriations authorities, and may or may not continue to
subject to a food recall. The Secretary must set the fee
The Secretary is required to establish and publish the fee
be funded if authority expires. But, in general, FDA’s
amount at a level to fully cover the reinspection and/or
amounts annual y, setting fees so that each one covers
enforcement activities, such as those for food safety, are
recall costs and use the collection solely for that purpose. If 100% of the cost of the associated activity, with certain
based in broad, permanent authorities in the FFDCA. These the Secretary determines that a recall “was inappropriately
caveats. For the first five years that user fees are assessed,
authorities do not expire, and they are not accompanied by
required,” the fee must be waived or refunded. Other
the Secretary is to include a surcharge in order to recoup
authorized levels of appropriations. Decisions to apportion
language here addresses their collection, crediting and
the costs associated with establishing the user fee
annual appropriations among FDA’s various programs and
availability vis a vis appropriations, with a sunset for the
programs. Fees col ected for a given fiscal year for food
activities are made through the annual appropriations
fees after FY2014.
recall activities may not exceed $20 million. Fees collected
process without explicit directives in authorizing legislation. Under § 203, Exportation Certificate Program, the
for a given fiscal year for reinspection of both domestic
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FDA is currently authorized to collect several types of fees.
Secretary is authorized to impose a fee for food export
facilities and importers may not exceed $25 million
Among them are user fees and export certification fees,
certifications that meet the specifications of a foreign
combined. Despite these limitations, the Secretary may
neither of which may currently be collected for food-
purchaser and that do not conflict with the destination
collect fees from facilities or importers who become
related activities. FDA’s authority to collect user fees
country’s laws. (Such fees already may be charged for
subject to the fees after the limitations are reached. The
extends to human prescription drugs, medical devices, and
certifications of some other FDA-regulated products.) The
Secretary must credit to the following year any fees
animal drugs, under FFDCA Chapter VII, Subchapter C, §§
fee shall be “reasonably related” to the cost of issuing such
collected in excess of actual costs, and adjust fee amounts
735-740. General y, these fees can only be used to fund the
certificates; this fee authority is permanent.
for that following year to account for the excess fees and
“process for the review of applications.” (FDA reviews
other factors the Secretary determines are appropriate.
Section 204 establishes a new FFDCA § 744, requiring the
applications to determine whether to permit drugs, medical Secretary to assess and col ect a $500 annual fee for the
The Secretary is authorized to collect fees only to the
devices, and animal drugs to be legally marketed. Prior
registration of an importer of food, with administrative
extent that amounts have been specified in advance in
approval is not required for most foods, which can be
provisions somewhat comparable to those set under § 101
appropriations acts. Additional “triggers” apply. Fees
legally marketed without the agency’s prior permission.)
(above). (This fee is to be tied to the new requirement that
col ected in a given year must be refunded unless
The user fee programs have been authorized in five-year
such importers begin to register with FDA within one year
appropriations to FDA for food safety activities are
increments. Each authorization specifies the fee amounts
of enactment.) Importers that already must pay the facility
maintained at the FY2009 level, with specified adjustments.
FDA may col ect annual y, and makes the authority to
fee under § 101 are exempt from this importer registration
Fees can be used solely to fund the specified food safety
collect these fees contingent upon “triggers,” which require fee. This fee authority sunsets after FY2014.
activity.
that appropriated and internally allocated funding amounts
for certain activities meet specified threshold levels.
Note: The proposed food user fee is different from existing
user fees in several ways. First, the proposed fee would be
FDA’s authority to collect export certification fees extends
authorized indefinitely, while each of the existing user fees
to drugs, medical devices and biological products, according
have been authorized in five-year increments. Second, the
to FFDCA § 801(e)(4). A person who exports a human
fees would be used to fund inspection and enforcement
drug, animal drug, or device may request that the Secretary
activities for foods on the market. For other products, the
certify in writing that the product meets FFDCA
existing user fees only fund application-review related
requirements. If the Secretary issues a written export
activities, as defined in the law—though, as noted above,
certification, a fee may be charged.
FDA does not inspect foods before they can be marketed
Obama Administration: In addition to requesting
as it does some of the other products that it regulates.
increased funds for FY2010 (see above), the Administration
Third, the act does not authorize specific fee levels in
has endorsed the registration, reinspection, and export
advance, but rather allows the Secretary to set fee levels
certification fees in §§ 101, 108, and 203 of the House bill.
based upon estimated costs. For currently authorized fees,
the amounts are articulated in law, either individually, or in
aggregate, for a given type of fee.
Funding for Food Safety (§ 401)
This section authorizes, for activities of FDA’s Center for
Food Safety and Applied Nutrition, Center for Veterinary
Medicine, and related field activities in the Office of
Regulatory Affairs, such sums as may be necessary for
FY2011-FY2014. In addition, the Secretary is required to
increase the field staff of these three entities with a goal of
not fewer than: (1) 4,000 staff members in FY2011; (2)
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S. 510 (Senate-passed)
4,200 staff members in FY2012; (3) 4,600 staff members in
FY2013; and (4) 5,000 staff members in FY2014. Within the
total, field staff for food defense activities and for smuggled
food detection and removal shall be increased by 150
employees by FY2011.
THIRD PARTY ACCREDITATION (See also “Food Imports” section of this report, and “Laboratory Accreditation” and “Inspection of Foreign Facilities” rows of this table.)
The use of so-called third parties is increasingly being
Certification and Accreditation (§ 109, part)
Accreditation of Third-Party Auditors (§ 307)
promoted as a method for helping regulators such as the
FDA to carry out their oversight responsibilities,
Appears to be less detailed with regard to how the
Amends FFDCA Chapter VIII (regarding imports and exports),
particularly when they are being asked to stretch and
Secretary is to establish a third-party certification program.
adding a new § 808, for a system of third-party auditors and
carefully target finite inspection dollars and personnel.
As noted, qualified certifying entities are to be accredited
audit agents that are accredited to certify that entities involved
However, the idea is controversial, particularly among food
and given the responsibility to provide such certifications
with imports are meeting applicable FDA requirements.
safety advocates, who have expressed concern about
when the Secretary determines such certifications are
Generally, the Secretary would first recognize accreditation
potential conflicts of interest between auditors and the
needed, and the specifics of that certification, including its
bodies. Such bodies in turn could accredit the third-party
companies they audit and about potentially less rigorous
format, would be left to the Secretary’s regulatory
auditors or audit agents, who in turn could be tasked to certify
oversight. They cite a number of recent food safety crises
discretion. § 109 defines “qualified certifying entity” as “an
eligible entities. Defines the following terms: audit agent,
including the Salmonella contamination of peanut products
agency or a representative of the government from which
accreditation body, third-party auditor, accredited third-party
in late 2008 and early 2009, even though the peanut
the article originated, as designated by such government or
auditor, consultative audit, eligible entity, and regulatory audit.
product supplier had passed several private third-party and
the Secretary; or an individual or entity determined by the
The Secretary must establish the new system within two years
state inspections.
Secretary or an accredited body recognized by the
Secretary to be qualified to provide a certification...”
of enactment and is required to: promptly revoke recognition
Among many questions is the definition of a “third party.”
of accreditation bodies found not in compliance with this
Broadly, it may be any entity or person that is formal y
Requires the Secretary to issue regulations to ensure that
section’s requirements and develop model accreditation
assigned one or more responsibilities that otherwise would
certifying entities and their auditors are free from conflicts
standards (within 18 months after enactment), taking into
be performed by another entity. In practice and in
of interest (in doing so, the Secretary may rely on or
account existing standards so as to avoid duplication of efforts
proposed legislation, third parties might variously and
incorporate international certification standards), Contains
and costs. Accreditation bodies must submit to the Secretary a
specifically be defined as a state or local agency, another
extensive language on what these regulations are to
list of all accredited third-party auditors and audit agents they
federal agency, a foreign government, a professional or
stipulate, such as that entities have written policies; that
have accredited.
scientific body, or even a private company, often one that
they obtain and maintain annual declarations of al
Accreditation bodies must, prior to accrediting a foreign
specializes in the task to be performed. Private companies
personnel involved in audits regarding their financial
government or foreign government agency, perform reviews
frequently rely on third party auditors, certifying agents and
interests in any producer, manufacturer, and other specified and audits of that government or agency’s food safety
the like, often including provisions in their contracts with
types of food companies; that they not be owned,
programs, systems, and standards, as the Secretary deems
suppliers, for example, that a third party verify that certain
operated, control ed, or have any other financial ties to
necessary, to determine that the foreign government is capable
specifications—whether safety, quality, quantity, or other
those or the products they are certifying. (However, the
of ensuring that entities or foods it certifies will meet the
desired attributes—are being achieved. Within the federal
certifying entity could provide consultative services to a
requirements of the FFDCA. Prior to accrediting foreign
government, examples include a variety of voluntary third-
facility it is certifying so long as the Secretary has approved
cooperatives and other third parties, accreditation bodies must
party auditing programs. For example, “Process Verification
its procedures ensuring the separation of these two
perform reviews and audits as the Secretary deems necessary
and Audit Based Programs,” operated by USDA’s
functions.)
to determine that the entities to be certified have systems in
Agricultural Marketing Service (AMS) and are funded
The Secretary must require that, to the extent applicable,
place to ensure the entities or foods will meet the
through user fees. These programs are intended primarily
any certification provided by a certifying entity be renewed
requirements of the FFDCA.
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to certify food quality and marketing attributes, as opposed
whenever the Secretary deems it appropriate; and he/she
Accreditation bodies may not accredit a third party auditor
to safety requirements per se.
must refuse to accept any certification determined to be no unless it agrees to issue a written food or facility certification
longer valid or reliable. The Secretary must provide for the
FDA appears to have argued in the past that its authority is
to accompany each food shipment into the United States from
electronic submission of certifications, in coordination with
broad enough, under the FFDCA and the PHS Act, at least
an eligible entity. The Secretary must consider certifications of
Customs and Border Protection.
to propose regulations on how independent sampling
foods offered for import and participation in the voluntary
services and private laboratories can be used to satisfy food Authorizes the Secretary, in evaluating an accreditation
qualified importer program when targeting inspection
import requirements. However, FDA does not currently
body, to observe that body’s on-site audits of qualified
resources and must use certification to determine whether
regulate private laboratories that analyze imported, FDA
certifying entities, and to conduct on-site audits of certified
food meets the requirements for import and to determine
regulated goods. (Under FFDCA § 704, FDA has been
facilities “upon request. .... and upon presentation of
whether facilities are eligible for the voluntary qualified
required to have published criteria for accrediting
appropriate credentials, at reasonable times and within
importer program established in § 302 of this act. Accredited
independent persons to conduct inspections related to
reasonable limits and in a reasonable manner ....” to include
third-party auditors can only issue food and facility
Class II and III devices.)
access to records.
certifications after conducting certain audits and activities. Only
the Secretary and accredited third-party auditors can provide
In January 2009, following a request for information and
facility certifications. Only the Secretary, a Secretary-
publication of a draft document, FDA issued guidance
designated agency or representative of the country from which
setting criteria for others’ use of voluntary third-party
the food for import originated, or accredited third-party
certification programs for foods and animal feeds, noting
auditors can provide food certifications.
that the federal government “supports voluntary
certification programs as one way to help ensure products
Accredited third-party auditors or audit agents must prepare
meet U.S. safety and security standards and to al ow federal
audit reports, which are to include a number of specified
agencies to target their resources more effectively.” FDA
elements; provide, at the Secretary’s request, an onsite audit
has also published a notice of a pilot program of voluntary
report or other reports or documents required for the audit
third-party certification for imported shrimp.
process for any eligible entity it has certified (with certain
exceptions); and immediately notify the Secretary of the
Obama Administration: Dr. Hamburg’s testimony
discovery during an audit of “a condition that could cause or
expresses support for relying not only on foreign
contribute to a serious risk to the public health” and the
governments for international inspections but also having
identification of the eligible entity subject to the audit. Third-
the flexibility to explore use of an accreditation system and
party auditors and audit agents must adhere to a series of
audit the performance of accredited third parties.
explicit prohibitions in this section designed to avoid conflicts
of interest. The Secretary is required to promulgate
regulations within 18 months of enactment to protect against
conflicts of interest between accredited third-party auditors
and eligible entities to be certified by such auditors or audit
agents.
The Secretary must withdraw accreditation from a third-party
auditor in certain circumstances, such as if a food certified by
the auditor is linked to an outbreak of foodborne illness, and
the Secretary must also establish procedures to reinstate
accreditations that have been withdrawn. The Secretary must
also establish, by regulation, a program similar to that used by
USDA, by which third-party auditors and audit agents
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reimburse FDA for the cost of establishing and administering
the accreditation system. The reimbursement program must
be revenue neutral and not generate surplus revenue.
Eligible entities must apply for annual recertification if they
intend to participate in the voluntary qualified importer
program or if they are required to provide certification to the
Secretary for food offered for import into the U.S. False
statements made to or by accredited third-party auditors are
subject to criminal penalties. The Secretary must, at least once
every 4 years, reevaluate accreditation bodies and evaluate the
performance of accredited third-party auditors and audit
agents (in part through the compliance history of the entities
they certified). The Secretary may conduct onsite audits of
certified entities with or without the accredited third-party
auditor present. The Secretary must make publicly available a
registry of accreditation bodies and third-party auditors. Audits
performed are not considered inspections under FFDCA §
704, and this section does not af ect the Secretary’s authority
to inspect any eligible entity.
LABORATORY ACCREDITATION (See also “Third Party Accreditation”, “Inspection of Foreign Facilities” and “Import Certification” rows of this table.)
Neither the FFDCA nor applicable regulations address the
Testing by Accredited Laboratories (§ 110)
Recognition of Laboratory Accreditation for
accreditation of food laboratories or the establishment of
Analyses of Foods (§ 202)
laboratory networks.
Establishes a new FFDCA § 714, which requires the
Secretary to establish a standards-based program for the
Subsection (a) establishes a new FFDCA § 422, requiring the
FDA continues to support an existing Food Emergency
recognition of laboratory accreditation bodies that accredit
Secretary, within two years of enactment, to establish a
Response Network (FERN), a nationwide network made up laboratories to perform analytical testing for the purposes
program for food testing by accredited laboratories that meet
of more than 130 federal, state and local public health
of this section. In evaluating whether such bodies meet the
certain requirements established by the Secretary; to establish
laboratories that support emergency response activities
Secretary’s standards, the Secretary is authorized to
a publicly available (subject to national security concerns)
related to food defense and food safety. The FDA Office of
observe these bodies’ on-site audits of laboratories, and to
registry of accrediting bodies recognized by the Secretary and
Regulatory Affairs publishes a Laboratory Manual with a
conduct an on-site audits under specified conditions. The
accredited laboratories (such accredited entities would be
section on “Private Laboratory Guidance.” The Guidance
Secretary is required to publish on the FDA website a list
required to report any changes to the Secretary). Foreign labs
seeks to “establish a uniform, systematic, and effective
of accreditation bodies.
would need to meet the same accreditation standards as
approach to ensuring that private labs performing analyses
domestic labs. The Secretary shall develop model accreditation
on FDA-regulated imported commodities submit
Any analytical testing must be done by a laboratory that is
standards that address sampling and analytic procedures,
scientifically sound data.” The Guidance, although
accredited by an above-accredited body and that samples
quality controls, personnel training and qualifications, and other
unenforceable, provides recommendations on sampling
such articles with adequate controls to ensure the integrity
matters. The Secretary shall review accreditation bodies at
techniques, requirements of lab analysts, reviewing the
of the samples, except that testing pursuant to FFDCA
least once every five years and promptly revoke recognition
analyzed packages, and auditing analyzed samples.
§801(a) (relating to testimony on refused imports) must be
for an accrediting body that is not in compliance with this
by an independent laboratory. This section contains
section. Food testing shall be conducted by accredited labs no
In January 2009, FDA issued guidance regarding voluntary
notification requirements for accreditation bodies and for
later than 30 months after enactment, unless otherwise
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third-party certification programs for foods and feeds. The
others (such as the results of all analyses conducted),
exempted.
guidance does not focus on laboratory accreditation, but
among other provisions. Any violation of this section’s
rather the ways in which third-party certifiers should use
requirements is considered a prohibited act under the
Food testing in the following situations shall be conducted
laboratory results in their assessments. The guidance, which FFDCA.
by a federal laboratory or a laboratory accredited according
also is not enforceable, says that laboratories should
to the requirements of this section whenever such testing
conform to existing international standards and guidelines.
is: (1) by or for an owner or consignee in response to a
specific testing requirement under the FFDCA or its
regulations when applied to address an identified or
suspected food safety problem and as required by the
Secretary as the Secretary deems appropriate; and (2) on
behalf of an owner or consignee in support of an imported
food submission under Section 801(a) and under an FDA
Import Alert that requires successful consecutive tests.
Any such testing results must be sent directly to the FDA,
unless the Secretary by regulation exempts the submission
of those results upon a determination that the results “do
not contribute to the protection of public health.” Certain
exceptions may apply.
If testing performed by an accredited state or local
government laboratory results in a state recalling a food,
the Secretary shall review the sampling and testing results
for the purpose of determining the need for a national
recall, or other compliance and enforcement activities. This
authority does not limit the ability of the Secretary to
review and act upon information from food testing,
including determining the sufficiency of such information
and testing.
Subsection (b) requires the Secretary, within 180 days of
enactment and biennial y thereafter, and in consultation
with federal agencies and state, local, and tribal
governments, to make a publical y available report to
Congress regarding progress in implementing a national
food emergency response laboratory network. Such a
network: (1) provides ongoing surveillance, rapid detection,
and surge capacity for large-scale food-related emergencies,
including intentional adulteration of the food supply; (2)
coordinates the capacities of state, local, and tribal food
laboratories, including data sharing to develop national
situational awareness; (3) provides accessible, timely,
accurate, and consistent food laboratory services
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nationwide; (4) develops and implements a methods
repository for use by federal, state, and local officials; (5)
responds to food-related emergencies; and (6) is integrated
with relevant laboratory networks administered by other
federal agencies.
MANDATORY RECALL AUTHORITY (See also “Mandatory Recall Authority” section of this report.)
The Secretary does not have mandatory recal authority for Notification, Nondistribution, and Recall of
Mandatory Recall Authority (§ 206)
foods, except for infant formula under FFDCA § 412(f). A
Adulterated or Misbranded Food (§ 111)
voluntary recal by a manufacturer or distributor may be
Subsection (a) of this section establishes a new FFDCA § 423
undertaken at any time for other foods and al other FDA-
This section establishes a new FFDCA § 420, effective not
regarding recal of food. If the Secretary determines, based
regulated products. In urgent situations, FDA may request a later than one year after enactment, which requires certain
on information gathered through the reportable food registry
voluntary recall of an FDA-regulated product [21 CFR
persons who place food in commerce to notify the
under FFDCA § 417 or through any other means, that there
7.40(b)]. The Secretary has authority under FFDCA § 304
Secretary of potential food safety problems; provides the
is a reasonable probability that an article of food (other than
to seize foods, drugs, and cosmetics that are adulterated or
Secretary with authority to request a voluntary recall of
infant formula) is adulterated under FFDCA § 402, or
misbranded when introduced into or while in interstate
food and to order that distribution of a food be ceased; and misbranded under FFDCA § 403(w) (specifical y regarding
commerce, or while held for sale after shipment in
establishes authority of the Secretary to mandate a recall,
al ergen labeling), and the use of or exposure to such article
interstate commerce.
with procedures reflecting two different levels of threat
will cause serious adverse health consequences or death to
that may be posed by an affected food.
humans or animals, the Secretary shall provide the
Obama Administration: One of the actions announced
responsible party (as defined in FFDCA § 417) with an
by the FSWG was to begin enhancing communication to
FFDCA § 420, subsection (a), requires a responsible party
opportunity to cease distribution and recal such article.
the public, including through an improved individual alert
[as defined in FFDCA § 417(a)(1)] or a person required to
system allowing consumers to receive food safety
register to import food under § 801(r) (as established by
If a person fails to comply voluntarily with a request by the
information such as notification of recalls. The FSWG, and
this act), to notify the Secretary if there is reason to believe Secretary to cease distribution or sale of, or to recal , an
the Statement of Administration Policy on H.R. 2749, noted that an article of food when introduced into or while in
article of food, the Secretary may order the person to cease
support for mandatory recal authority. The Hamburg and
interstate commerce, or while held for sale (regardless of
distribution and sale, and to immediately notify all persons
Taylor testimonies express support for the House bill
whether the first sale) after shipment in interstate
“manufacturing, processing, packing, transporting,
provision.
commerce, is adulterated or misbranded in a manner that
distributing, receiving, holding, or importing and selling such
presents a reasonable probability that the use or
article;. .and to which such article has been distributed,
consumption of, or exposure to, the article (or an
transported or sold, to immediately cease distribution of
ingredient or component used in any such article) will cause such article,” including products distributed to a warehouse-
a threat of serious adverse health consequences or death
based third party logistics providers. The Secretary shal offer
to humans or animals. (This language is similar to the
the responsible party an opportunity for an informal hearing
reporting threshold currently established under FFDCA §
within two days of issuance of such an order. If the Secretary
417.) Failure to notify the Secretary when required is
subsequently determines that the affected foods should not
prohibited under FFDCA § 301.
remain in commerce, the Secretary shal : amend the order to
require a recal ; specify a timetable for the recal ; require
FFDCA § 420, subsection (b), authorizes the Secretary to
periodic reports from the responsible party; and provide
request a voluntary recal by any person who distributes an
notice to consumers to whom the food was or may have
article of food that the Secretary has reason to believe is
been distributed. If, after the informal hearing, the Secretary
adulterated, misbranded, or otherwise in violation of the
determines that adequate grounds do not exist for the
FFDCA.
order’s required actions, the Secretary shal vacate or modify
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FFDCA § 420, subsections (c) and (d), authorize the
the order.
Secretary to issue an order to cease distribution of any
Alcoholic beverages are exempt from a mandatory recal or
article of food that the Secretary has reason to believe that
any action pending initial action by the Alcohol and Tobacco
the use or consumption of, or exposure to, an article of
Tax and Trade Bureau.
food may cause serious adverse health consequences or
death to humans or animals, with an appeal process and
The Secretary shall work with state and local public health
other administrative matters specified (including limits on
officials in carrying out this section, as appropriate. In
the Secretary’s authority to delegate decisions regarding
conducting a recal under this section, the Secretary shal
orders). Subsection (e) requires the Secretary to issue a
issue a press release, and other notices as appropriate, to
mandatory recal order if the Secretary determines that
provide consumers and retailers with information about the
problems have not been addressed through procedures
affected articles of food and the risks posed; and shall consult
under subsections (c) and (d). Certain requirements of such USDA policies regarding providing to the public a list of retail
order are stipulated.
consignees receiving products involved in a Class I recall, and
consider providing such a list to the public, if appropriate. If
FFDCA § 420, subsection (f), authorizes the Secretary to
available, an image of the recal ed article must be published
proceed directly to a mandatory recal order if the
on the FDA website. The Secretary’s authority to issue or
Secretary has credible evidence or information that an
vacate recal orders shal not be delegated to anyone other
article of food subject to an order to cease distribution
than the FDA Commissioner and this section shall not affect
presents an imminent threat of serious adverse health
the authority of the Secretary to request or participate in a
consequences or death to humans or animals. In such case,
voluntary recal . The Secretary shal establish an “incident
the person must immediately recall the food while
command operation” within HHS no later than 24 hours
stipulated appeal procedures are carried out. (“Serious,"
after the initiation of a mandatory recall that will adhere to
which distinguishes the thresholds for the routine
requirements for coordinated and timely communication.
(subsection (e)) and emergency (subsection (f)) mandatory
Not later than 90 days after enactment the Secretary shal
recall authorities, is not defined.)
include on the FDA website a consumer-friendly search
The Secretary is required, as the Secretary deems
engine for locating information about recalled food.
necessary, to notify consumers, and state and local health
Under subsection (c) of this section, pursuant to FFDCA §
officials, of any recall order issued under this section.
303(f)(2)(A), a person who does not comply with a recal
Failure of a person to comply with any order issued by the
order under this section shall be subject to civil money
Secretary under this section is prohibited under FFDCA
penalties. Under subsection (d) of this section, failure to
section 301. Any articles of food intended for import and
comply with such an order is prohibited under FFDCA § 301.
subject to a cease-distribution or recal order under this
section shal be refused entry, under FFDCA section 801.
Reporting requirements:
Nothing in this section shall limit the Secretary's authority
• Requires GAO to submit a report to Congress (no later
to assure food safety through any other provisions of the
than 90 days after enactment) that identifies and evaluates
FFDCA, or the Public Health Service Act.
federal, state and local agencies with mandatory recall
authority of food, considers models for famer restitution in
the case of erroneous recal s, and recommends how to
minimize economic costs.
• Depending on the findings in GAO’s review, USDA shall
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conduct a feasibility study of implementing a farmer
indemnification program to provide restitution to producers
for incurred losses as a result of an erroneous mandatory
recal . This report wil be submitted to the House and Senate
Agriculture Committees.
• The Secretary shall submit an annual report to the Senate
HELP and House Energy and Commerce Committees on the
use of recal authority under § 423. This report shall identify
foods subject to a public health advisory; the number of
responsible parties given an opportunity to cease distribution
of or recal a food; the number of recal orders; and a
description of instances in which there was no testing for
adulteration.
REPORTABLE FOOD REGISTRY (See also “Notification of Contaminated Products and Product Tracing” section of this report.)
The FDA Amendments Act of 2007 (FDAAA, P.L. 110-85)
Reportable Food Registry: Exchange of Information
Improving the Reportable Food Registry (§ 211)
created FFDCA § 417, which required FDA to establish a
(§ 112)
reportable food registry to facilitate product identification
Amends FFDCA § 417 to require the Secretary to obtain
and tracing. Under FFDCA § 417, a “reportable food” is “an The food registry reporting requirements apply to facilities
from a responsible party consumer-oriented information
article of food (other than infant formula) for which there is that are required to register under FFDCA § 415. This
regarding reportable foods (except for fruits and vegetables
a reasonable probability that the use of, or exposure to,
section of the House bill expands coverage to farms where
that are raw agricultural commodities), no later than 18
such article of food will cause serious adverse health
food is produced for sale or distribution in interstate
months after enactment: description of the food, affected
consequences or death to humans or animals,” and
commerce, to restaurants and other retail food
product identification codes, contact information for
registered food facilities must notify the FDA electronically
establishments, and to those required by this bill to register responsible parties, and other information deemed relevant
about such a reportable food. Although FDA did not meet
as importers. The bill newly requires the reporting also of
by the Secretary. The Secretary shall also prepare a one-
the deadline to implement the registry within 1 year of
documented results of any sampling and testing of a
page summary of the reportable food, to be available by
enactment of FDAAA, the agency published compliance
reportable food article and of a component of a food
internet and for grocery stores, as part of its notification
guidance for industry in September, 2009, and the reporting article, including: tests conducted pursuant to new § 418
process. If a grocery store sold a reportable food subject to
requirement became effective at that time.
(Hazard Analysis and Risk-Based Preventive Controls), new
posting, the store shal prominently display such summary
§ 418A (Food Safety Plan), new § 419 (Performance
information for 14 days no later than 24 hours after the
Standards), or new § 714 (Testing by Accredited
one-page notification is published. Within one year of
Laboratories); analytical results of facility environmental
enactment, the Secretary shall publish a list of “conspicuous
testing; or any other information deemed relevant by the
locations” for posting such notifications. Failure to post a
Secretary.
required notification is prohibited.
This section does not amend the definition of “reportable
food,” which establishes the reporting threshold. The
Secretary must offer an alternative to electronic reporting
for farms, restaurants, and retail food establishments.
Finally, § 112 of the bill contains extensive language on the
conditions under which food registry information may or
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may not be shared with or disclosed to others including
other agencies and to the public.
Note: The bill here references 21 CFR 1.227(b)(3) to define
a farm as “... a facility in one general physical location
devoted to the growing and harvesting of crops, the raising
of animals (including seafood), or both. Washing, trimming
of outer leaves of, and cooling produce are considered part
of harvesting. The term ``farm'' includes: (i) Facilities that
pack or hold food, provided that all food used in such
activities is grown, raised, or consumed on that farm or
another farm under the same ownership; and (ii) Facilities
that manufacture/process food, provided that al food used
in such activities is consumed on that farm or another farm
under the same ownership.” The bill here also makes the
same reference to define a retail food establishment.)
EXPEDITING IMPORTS (See also “Food Imports” section of this report.)
The FFDCA does not explicitly provide authority for
Safe and Secure Food Importation Program (§ 113)
Voluntary Qualified Importer Program (§ 302)
expediting imports. Among the questions raised during the
policy debate: Should importers, or those foreign facilities
Amends FFDCA Chapter VIII (regarding imports and
Amends FFDCA Chapter VIII (regarding imports and
which supply them, that have good histories of compliance
exports), adding a new § 805, which appears to leave more
exports), adding a new § 806. It requires the Secretary,
with U.S. food safety laws, and/or that import relatively
aspects of implementation to the Secretary’s discretion
within 18 months of enactment: (1) to establish, in
low-risk foods, be permitted to follow abbreviated
than does the expedited import program proposed in S.
consultation with the Secretary of Homeland Security, a
procedural requirements? If so, what if any additional
510. This section authorizes the Secretary ( in coordination
voluntary program to expedite review and importation of
standards should they have to meet?
with Customs and Border Protection) to establish a
foods from qualified importers; and (2) to issue applicable
program to facilitate the movement of food through the
program guidance. An importer is defined in this section as
import process, if the importer verifies that each facility
“the person that brings food, or causes food to be brought,
involved in its production, manufacture, processing,
from a foreign country into the customs territory of the
packaging, and holding is in compliance with safety and
United States.” An importer that intends to participate in
security guidelines that the Secretary would develop (taking the program under this section in a fiscal year shall submit a
into account a number of prescribed factors). The importer notice to the Secretary of such intent at time and in a
also is to ensure that appropriate safety and security
manner established by the Secretary. Eligibility is limited to
controls are in place throughout the supply chain and to
an importer who offers for importation a food from a
provide supporting information to the Secretary.
facility that has a certification under § 809(b), as established
by this act. The Secretary shall consider, in making such
determinations, the risk posed with respect to: (1) the
nature of the food; (2) the compliance history of the
foreign supplier; (3) the regulatory system of the country of
export; (4) the compliance of the importer with the
requirements of the foreign supplier verification program
under § 805, as established by this act; (5) recordkeeping,
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testing, inspections and audits of facilities, traceability of
articles of food, temperature controls, and sourcing
practices of the importer; (6) the potential risk for
intentional adulteration of the food; and (7) other factors
that the Secretary determines appropriate. The Secretary
shall review each importer’s qualifications at least every
three years, and shall promptly revoke an importer’s
qualified status if the importer is found not to be in
compliance. Making of false statements under this authority
may subject an importer to criminal fines and/or
imprisonment, pursuant to 18 U.S.C. § 1001.
INFANT FORMULA
FFDCA § 412 sets forth detailed requirements whereby
Infant Formula (§ 114)
No comparable provision.
manufacturers of infant formula are required to provide
FDA with assurances of the nutritional quality of their
Alters several requirements which apply to a manufacturer
formulations before marketing the formula. FDA has
of a new infant formula; e.g., FDA would have additional
requirements for certain labeling, nutrient content, quality
time to review certain safety information regarding new
control procedures, and company recordkeeping and
ingredients.
reporting. The FDA website states that the agency is also
working to finalize a proposed rule for good manufacturing
practices, quality control procedures, quality factors,
notification requirements, and reports and records, for the
production of infant formulas.
FOODBORNE ILLNESS SURVEILLANCE AND PUBLIC EDUCATION (See also “Foodborne Illness Surveillance and Outbreak Response” section of this report.)
Surveillance for foodborne illness is carried out by the
Surveillance (§ 121)
Surveillance (§ 205)
states, with assistance from the CDC. States also conduct
investigations of foodborne outbreaks, in coordination with
This section generally mirrors the language in § 205 of the
For the purposes of this section, “foodborne illness
CDC, either FDA or FSIS (depending on implicated or
Senate bill, but lacks two of the provisions: the requirement outbreak” is defined as two or more cases of a similar
suspected foods), and, if appropriate, other federal
for a working group on foodborne illness surveillance; and
illness resulting from the ingestion of a certain food. This
agencies. FDA is authorized to carry out such
the reauthorization of the food safety capacity grants.
section requires the Secretary, acting through the Director
investigations, or to coordinate with states in doing so: (1)
of the CDC, to enhance foodborne illness surveillance
Public Education and Advisory System (§ 122)
under broad, permanent authorities in FFDCA § 702
systems by, among other things, enhancing system capacity;
regarding examinations and investigations, and § 909
This section of the bill requires the Secretary, in
improving coordination and information sharing;
regarding authority to assist states with examinations and
cooperation with private, state and other public
incorporating research findings; making surveillance data
investigations; and (2) under several broad, permanent
organizations, to design and implement a national public
available to the public in appropriate formats; and
disease control authorities of the Secretary of HHS in Title
education program on food safety. The section describes
integrating systems and data with other biosurveillance and
III of the PHS Act, which underpin CDC’s activities as well.
the elements to be included in the program, and further
related federal, state and local surveillance systems.
These include PHS Act § 301 regarding research and
requires the Secretary to work with states and others to
Appropriations are authorized for these activities at $24
investigations, §§ 311 and 317 regarding federal-state
develop and incorporate into the public education program
million annually (FY2011-FY2015). The Secretary must also
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cooperation, and § 361 regarding control of communicable
regional and national advisories concerning food safety.
establish a working group, comprised of public- and private-
diseases. PHS Act § 317R provides an explicit but expired
sector experts and stakeholders, to meet and report at
authority of the Secretary to award grants to state and
least annual y, and make recommendations for the
tribal governments to enhance food safety surveillance and
improvement of foodborne illness surveillance systems.
laboratory capacities. Although this authority has expired,
the Secretary may carry out this activity under the broad,
The Secretary shall, within one year of enactment, conduct
permanent authorities mentioned earlier.
an assessment of state and local food safety and defense
capacities, and shall subsequently develop and implement
A foodborne illness “outbreak” is not defined in law or
strategies to enhance these capacities, in order to achieve a
regulations. In public health practice, and as used by CDC, a
number of stated goals. This section also reauthorizes the
“foodborne disease outbreak” is defined as “the occurrence
food safety capacity grants in PHS Act § 317R at $19.5
of two or more cases of a similar illness resulting from the
million for FY2010, and such sums as may be necessary for
ingestion of a common food.” As a practical matter,
FY2011 through FY2015.
particularly for less serious hazards, foodborne disease
outbreak investigations are not always launched when only
two people are affected. Exceptions may be made for
serious problems such as botulism.
RESEARCH
FDA, along with other federal agencies, is already involved
Research (§ 123)
Food Safety Integrated Centers of Excellence (§
in a variety of research activities, in such areas as how and
210)
where food contamination occurs, biotechnology and
Requires the Secretary to conduct research to assist in
allergenicity issues, seafood safety, color additives,
implementation of the Act, including studies to improve
Section 210(b) of this section, regarding Food Safety
consumer studies, the detection, characterization, and
sanitation and food safety practices in food production,
Integrated Centers of Excel ence, which would, among
behavior of foodborne pathogens, for example.
harvesting, processing, develop improved monitoring and
other things, conduct food safety research. Requires the
Collaborative research efforts have been underway for
food inspection techniques, develop efficient and rapid
Secretary and the CDC Director (in consultation with
some time with USDA’s Agricultural Research Service and
methods for detecting the presence of food contaminants,
other groups) to designate five “Integrated Food Safety
National Institute of Food and Agriculture,, and with
among other specific areas of emphasis.
Centers of Excellence” at selected state health departments
academia, state health and agricultural officials, industry and
to serve as resources for federal, state, and local public
others.
health professionals. Authorizes the appropriation of such
sums as necessary to carry out this provision.
SEIZURE OF FOOD
FFDCA § 304 spells out the grounds, jurisdiction, and
Procedures for Seizure (§ 131)
No comparable provision.
procedures to be used to seize FDA-regulated products
through a court order. (This extensive FFDCA provision and
Appears to expedite the process for seizing adulterated or
the implementing steps involved are detailed in FDA’s
misbranded articles of food by altering the current
statutory procedures for doing so.
134 See http://www.fda.gov/ICECI/ComplianceManuals/RegulatoryProceduresManual/default.htm.
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ADMINISTRATIVE DETENTION OF FOOD
The Secretary has authority for the administrative detention of
Administrative Detention (§ 132)
Administrative Detention of Food (§ 207)
foods pursuant to FFDCA §§ 304(h) and 801. Under FFDCA §
304(h), an FDA officer or qualified employee may order the
Similar to the Senate measure, this section changes the
This section amends FFDCA § 304(h) in two ways. First,
detention of an article of food for up to 30 days if the FDA
FFDCA § 304(h) requirement for “credible evidence or
the requirement for “credible evidence or information” is
official “has credible evidence or information indicating that
information” to “reason to believe” and changes the
lowered to “reason to believe.” Second, the standard “a
such article presents a threat of serious adverse health
standard of “a threat of serious adverse health
threat of serious adverse health consequences or death to
consequences or death to humans or animals.” The detention
consequences or death to humans or animals” to
humans or animals” is changed to “adulterated or
request must be approved by the Secretary or the Secretary’s
“adulterated or misbranded,” and also adds “or otherwise
misbranded.” Thus, FFDCA § 304(h)(1)(A) would read:
designated official. Detention orders may be appealed to the
in violation of this Act.” Unlike S. 510, the House bill
“An officer or qualified employee of the Food and Drug
Secretary.
extends the maximum period to detain an article of food
Administration may order the detention ... of any article of
under § 304(h) from 30 days to 60 days; strikes a sentence
food that is found during an inspection, examination, or
Under FFDCA § 801, FDA officers and qualified employees
regarding how a subsection may be construed regarding
investigation under this Act conducted by such officer or
must request the Secretary of Homeland Security to hold food
delivery of an article of food pursuant to the execution of a
qualified employee, if the officer or qualified employee has
at the port of entry for up to 24 hours if they possess “credible bond while the food is subject to a detention order; and
reason to believe that such article is adulterated or
evidence or information indicating that an article of food
extends the time al owed for the Secretary to act after an
misbranded.” Within 120 days of enactment, the Secretary
presents a threat of serious adverse health consequences or
appeal of a detention order has been filed from 5 days to
shall issue an interim final rule to implement the amended
death to humans or animals,” and that of icer or qualified
15 days. The Secretary is required to issue regulations or
authority, and the amendments to FFDCA § 304(h) shal be
employee “is unable to inspect, examine, or investigate such
guidance to implement the amendments, and the
in effect 180 days after enactment.
article upon the article being offered for import.” The request
amendments shall take effect 180 days after enactment.
to hold the food must be approved by the HHS Secretary or
his or her appropriately designated of icial. The FDA’s ability to
hold such food for up to 24 hours is intended to enable “the
Secretary to inspect, examine, or investigate the article as
appropriate.”
Obama Administration: The Hamburg and Taylor
testimonies express support for § 132 of the House bill.
QUARANTINE AUTHORITY
The seizure provisions of FFDCA § 304 do not appear to
Authority to Prohibit or Restrict the Movement of
No comparable provision.
specifically authorize geographical quarantines of an article
Food (§ 133)
of food in the United States.
Amends FFDCA § 304 (seizure section) by adding that
On occasion, FDA does subject certain imports or groups
where the Secretary, after consulting with the Governor or
of imports from an entire country or region to “detention
other appropriate state elected official, “determines that
without physical examination” until the importer can
there is credible evidence or information that an article of
demonstrate that the product satisfies FDA requirements.
food presents an imminent threat of serious adverse health
Examples of this in 2007 were imports of all Chinese plant
consequences or death to humans or animals,” the
protein products (including wheat gluten and rice gluten)
Secretary is authorized to prohibit or restrict the
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after some were found to contain melamine, an unapproved movement of the article of food within the state or a
substance; and of al farm-raised shrimp, catfish, basa, dace,
portion of it. The Secretary must determine that “there is
and eel from China until the shippers of these products
no less drastic action that is feasible and that would be
could demonstrate that they were free of unapproved drug
adequate to prevent the imminent threat of serious adverse
residues.
health consequences or death to humans or animals.”
Violation of a prohibition or restriction is a prohibited act
under FFDCA § 301. The remainder of § 133 describes the
notification procedures the Secretary must fol ow (including
public announcement and publication in the Federal
Register) for such a prohibition or restriction, requires
renewal every 14 days, and includes limitations on the
ability to delegate quarantine authority to others.
CRIMINAL PENALTIES (See also “Criminal Penalties” section of this report.)
Under FFDCA § 301(a) (as adjusted by 18 U.S.C. §§ 3559
Criminal Penalties (§ 134)
No comparable provision.
and 3571) the maximum criminal penalty for individuals
convicted of a misdemeanor under the act is $100,000 if it
Any person who knowingly violates specified prohibited
does not result in death; $250,000 if it results in death;
acts under FFDCA § 301 would be subject to increased
and/or imprisonment of one year. The maximum criminal
penalties, of up to 10 years in prison and/or fines in
misdemeanor penalty for organizations (as adjusted by 18
accordance with the U.S. Criminal Code (Title 18 of the
U.S.C. §§ 3559 and 3571) is $200,000 if the offense does
U.S.C.). This section also requires the revision of penalties
not result in death and $500,000 if the offense results in
for violations of the FFDCA.
death.
For felony convictions the maximum criminal penalty for
individuals (as adjusted by 18 U.S.C. §§ 3559 and 3571) is
imprisonment for not more than three years or a fine of
not more than $250,000, or both. The maximum criminal
penalty for organizations (as adjusted by 18 U.S.C. §§ 3559
and 3571) is a fine of not more than $500,000.
Obama Administration: The Hamburg and Taylor
testimonies express support for § 134 of the House bill.
CIVIL PENALTIES
FFDCA § 303(f)(2) FFDCA subjects any person who
Civil Penalties for Violations Relating to Foods (§
No comparable provision.
“introduces into interstate commerce or delivers for
135)
introduction into interstate commerce an article of food
that is adulterated within the meaning of [FFDCA] section
Amends FFDCA § 303(f)(2) ) to delete restrictions on civil
402(a)(2)(B)” to a civil monetary penalty of up to $50,000 if
penalty provisions regarding pesticide chemical residues
an individual and up to $250,000 on any other person, to a
that result in a food being deemed adulterated under
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maximum of $500,000 for al such violations adjudicated in
FFDCA § 402(a)(2)(B). It also amends § 303(f)(2) by
a single hearing. However, 402(a)(2)(B) applies only to the
authorizing the Secretary to assess a civil penalty of up to
presence of illegal pesticide residues. The section further
$20,000 (not to exceed $50,000 in a single proceeding) on
exempts from this penalty any person who grew the article
an individual and of up to $250,000 on any other person
of food, and it prohibits use of FDA’s seizure, injunction, or
(not to exceed $1 million in a single proceeding) for
criminal authorities if such a civil monetary penalty is
committing a violation of FFDCA § 301 (prohibited acts).
assessed.
For knowing violations, maximum civil penalties for
individuals are $50,000 (not to exceed $100,000 in a single
Currently, there are no maximum civil penalties tied to
proceeding), and for any other person $500,000 (not to
FFDCA § 303(a), which addresses criminal penalties for
exceed $7.5 million in a single proceeding). Each prohibited
prohibited acts under the FFDCA.
act and each day is to be considered a separate offense.
Obama Administration: The Hamburg and Taylor
The rewording of this section appears to effectively
testimonies express support for § 135 of the House bill.
broaden the reasons for which civil penalties could be
applied; subjects those growing an article of food that is
adulterated under § 402(a)(2)(B) to them; and appears to
no longer preclude use of seizure, injunction, or criminal
authorities with regard to violations of § 402(a)(2)(B). It
does not strike § 303(f)(2)(C) regarding hearings on the
assessment of civil penalties.
IMPORT ENTRY FILINGS (See also “Food Imports” section of this report, and “Foreign Supplier Verification” row of this table.)
The FFDCA does not require those who are importers or
Improper Import Entry Filings (§ 136)
No comparable provision.
import brokers to register with FDA under the food facility
registration provisions of § 415.
This section amends FFDCA § 801 (imports and exports)
by authorizing the Secretary to require by regulation or
guidance the submission of documentation (in certain
circumstances, in consultation with Customs and Border
Protection) or other information for articles of food that
are imported or offered for import into the United States.
Failure to submit required information, submission of
inaccurate or incomplete information, is prohibited under
FFDCA § 301.
FOOD SUBSTANCES GENERALLY RECOGNIZED AS SAFE (GRAS)
This issue revolves around FDA’s exercise of so-called
Food Substances Generally Recognized As Safe (§
No comparable provision.
“generally recognized as safe” (GRAS) determinations.
201)
Under current law, substances which FDA agrees are
GRAS are exempt from the much more rigorous
Requires the Secretary to publish within 60 days on the
premarket approval process required for other food
FDA public website, notice of receipt of a request for a
additives. Under a 1997 proposed rule, FDA proposed
substance to be determined by the Secretary to be
creating a notification procedure for GRAS substances
General y Recognized As Safe (GRAS), and supporting
scientific justifications, among other provisions. This section
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through which manufacturers can notify the FDA of their
does not appear to address the GRAS notification
“determination that a particular use of a substance is
procedure, as it discusses requests for substances to be
GRAS,” thereby bypassing the regular federal rulemaking
determined by the Secretary to be GRAS. In the
procedures. In fact, FDA has been using this GRAS
notification procedure, the manufacturer or other
notification procedure since the publication of the
individual makes the conclusion that the substance is GRAS
proposed rule on an “interim policy” basis.
and the FDA states that it has “no questions” about this
conclusion, that the notice does not provide a basis for a
GRAS status determination, or that the individual has
stopped the GRAS notification process.
COUNTRY OF ORIGIN LABELING (COOL)
Since the 1930s, § 304 of the Tariff Act of 1930, as
Country of Origin Labeling (§ 202)
No comparable provision.
amended, has required most imports to carry labels so that
the "ultimate purchaser," usually the retail consumer, can
Amends the misbranding provision of FFDCA § 403 to
determine their country of origin. Certain products,
consider a processed food misbranded if its label fails to
including a number of agricultural commodities in their
identify the country in which final processing occurred. A
"natural" state such as meats, fruits and vegetables, were
non-processed food is misbranded if its label fails to identify
excluded. Effective in 2009, many retail food stores are now the country of origin. Processed foods and non-processed
required to inform consumers about the country of origin
foods are deemed to meet the requirements of this section
of fresh fruits and vegetables, seafood, peanuts, pecans,
if they are subject to and meet the requirements of,
macadamia nuts, ginseng, and ground and muscle cuts of
respectively, the U.S. Customs and Border Protection or
beef, pork, lamb, chicken, and goat, under provisions of the
USDA. The Secretary is required to promulgate final
2002 farm bill (P.L. 107-171) as amended by the 2008 farm
regulations on this provision within 180 days of enactment,
bill (P.L. 110-246).
and the new requirements take effect two years after
enactment.
The FFDCA does not expressly require country-of-origin
labeling (COOL) for foods. FFDCA § 403(e) does consider
a packaged food misbranded if it lacks a label containing the
name and place of business of the manufacturer, packer, or
distributor. However, this is not an indicator of the origin
of the product itself.
EXPORT CERTIFICATION FEES
Exportation Certificate Program (§ 203) is discussed
Authority to Collect Fees (§ 107) is discussed under
under the “Funding and Fees” section.
“Funding and Fees” above.
FOREIGN SUPPLIER VERIFICATION (See also “Mandatory Recall Authority” and “Food Imports” sections of this report, and “Import Entry Filings” row of this table.)
The FFDCA does not explicitly authorize, and does not
Registration for Commercial Importers of Food;
Foreign Supplier Verification Program (§ 301)
require, the establishment of a foreign supplier verification
Fee (§ 204); Registration for Customs Brokers (§
program. The FFDCA also does not require those who are
205); Unique Identification Number for Food
Amends FFDCA Chapter VIII (regarding imports and
importers or import brokers to register with FDA under
Facilities, Importers and Customs Brokers (§ 206)
exports) by adding a new § 805, effective two years after
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the food facility registration provisions of § 415. At a House These sections require an importer of foods to register
the date of enactment, requiring each importer to establish
Energy and Commerce Committee hearing on June 3, 2009, annual y with the Secretary and to submit an appropriate
risk-based foreign supplier verification activities. Importing,
U.S. officials acknowledged that they had no firm data on
unique facility identification as a condition of such
or offering for importation, a food by an importer who
the number of entities that import food.
registration. Further conditions for importers (but not
does not have such a program in place is prohibited under
FFDCA § 301, and the Secretary shall refuse admission to
Obama Administration: The Hamburg and Taylor
customs brokers) include compliance with “good importer
any such product that appears to be in violation of this
testimonies express support for § 204 of the House bill.
practices.” Among other provisions in this section is a
requirement that importers permit an officer or employee
requirement. Defines an importer as the U.S. owner or
of the Secretary to “inspect the facilities of such person and consignee of the article of food at the time of entry of such
have access to, and to copy and verify, any related
article into the United States; or the United States agent or
records.”
representative of a foreign owner or consignee of the
article of food at the time of entry of such article into the
The Secretary (in consultation with Customs and Border
United States.
Protection) must promulgate regulations on the measures
an importer must take to ensure that the importer has
The importer is required to develop a program that: (1)
adequate information about a food, its hazards, and
assures that imported food is not adulterated or
applicable requirements; the ability to verify that both the
misbranded; and (2) complies with the program of hazard
food and each person who produced, manufactured,
analysis and preventive controls in FFDCA § 418, or the
processed, packed, transported, or held the food including
produce safety requirements in FFDCA § 419, each as
its components are in compliance; and procedures to take
established by this act. Within one year of enactment, the
corrective actions regarding noncompliant foods. This
Secretary shall issue guidance and promulgate regulations
provision also authorizes the Secretary, in promulgating
regarding the development of foreign supplier verification
good import practices regulations, to incorporate
programs, including appropriate verification steps that
certification of compliance under FFDCA § 801(q) and
importers may apply to the products of their foreign
participation in the safe and secure food importation
suppliers, to assure that safety requirements are met. The
program under FFDCA § 805, and to take into account
importer shall maintain appropriate documentation for not
differences among importers and types of imports.
less than two years, and make such records available for
inspection. Importers of seafood, juice, or low-acid canned
Provisions in this part of the bill provide for conditions for
food whose products are currently in compliance with
suspending registrations, and for exemptions from the
FDA’s relevant standards and regulations are deemed to be
requirements by the Secretary, among other things. Failure
compliant with this section. The Secretary shall publish and
to register is prohibited under FFDCA § 301; any food
maintain a current list of participating importers.
offered for import that is not from a duly registered person
is misbranded under FFDCA § 403. Fees must be charged
to importers (but apparently not customs brokers, even
though “Fee” was in the title of § 205 marked up in
committee).
Improper Import Entry Filings (§ 136)
As previously noted, this section amends FFDCA § 801
(imports and exports) by authorizing the Secretary to
require by regulation or guidance the submission of
documentation (in certain circumstances, in consultation
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with Customs and Border Protection) or other information
for articles of food that are imported or offered for import
into the United States. Failure to submit required
information, submission of inaccurate or incomplete
information, is prohibited under FFDCA § 301.
INSPECTION OF FOREIGN FACILITIES (See also “Targeting of Inspections” section of this report, and “Inspection of Facilities”, “Laboratory Accreditation”, “Third Party
Accreditation,” and “Import Certification” rows of this table.)
FFDCA § 704 authorizes officers and employees designated
Prohibition Against Delaying, Limiting, or Refusing
Inspection of Foreign Food Facilities (§ 306)
by the Secretary of HHS to, among other things, enter and
Inspection (§ 207); Risk-Based Inspection Schedule
inspect “any factory, warehouse, or establishment in which
(§ 105)
Amends FFDCA Chapter VIII (regarding imports and
food, drugs, devices, or cosmetics are manufactured,
exports), adding a new § 807, authorizing the Secretary to
processed, packed, or held, for introduction into interstate
Amends FFDCA § 402 by newly considering a food
enter into arrangements and agreements with foreign
commerce or after such introduction.” Inspections must be
adulterated if it is from any farm, factory, warehouse, or
governments to facilitate the inspection of foreign facilities
conducted “at reasonable times and within reasonable
establishment and the owner, operator, or agent,” or any
registered under FFDCA § 415; and requiring the Secretary
limits and in a reasonable manner.” The refusal to permit
agent of a governmental authority in the foreign country,
to direct resources to inspections of foreign facilities,
such inspections is prohibited under FFDCA § 301.
“delays or limits an inspection or refuses to permit entry or suppliers, and food types, especially such facilities, suppliers,
“Interstate commerce” is defined under FFDCA § 201 to
inspection” under FFDCA § 414 (records inspection) or §
and food types that present a high risk (as identified by the
mean “(1) commerce between any State or Territory and
704 (factory inspection). (The remainder of the bill’s § 203
Secretary), to help ensure the safety and security of the
any place outside thereof, and (2) commerce within the
consists of similar proscriptions for drugs, devices, and
food supply of the United States.
District of Columbia or within any other Territory not
cosmetics.)
Imported foods shall be refused admission if “from a foreign
organized with a legislative body.” A “factory, warehouse,
The general risk-based inspection provisions in § 105
factory, warehouse, or other establishment of which the
or establishment” is not defined in the FFDCA; nor does
(above) apply to both imported and domestic inspections.
owner, operator, or agent in charge, or the government of
there appear to be any statutory distinction here between
As noted above, §105 requires foreign facilities to be
the foreign country, refuses to permit entry of United
foreign and domestic. Although the FFDCA appears neither inspected by an agency or representative of a foreign
States inspectors or other individuals duly designated by
to expressly include nor to expressly exclude foreign
country that is recognized by the Secretary as meeting U.S.
the Secretary, upon request, to inspect such factory,
facilities with regard to the right of inspection by the HHS
standards. (See also § 208 of the House bill, below.)
warehouse, or other establishment,” if an inspection is
Secretary or designee, the Bush Administration had argued
refused “during the 24-hour period after such request is
that FDA lacks the authority to refuse food imports when
Risk-Based Inspection Schedule (§ 105, part);
submitted, or after such other time period, as agreed upon
the agency has been denied access to a foreign facility.
Certification and Accreditation (§ 109, part)
by the Secretary and the foreign factory, warehouse, or
Note: Whether FDA now has what is often called
The Secretary has authority under § 105 (Risk-Based
other establishment.’’
“equivalency authority” is a matter of debate. “In a May 9,
Inspection Schedule) to “recognize Federal, State, and local
The Secretary of Commerce, in coordination with HHS,
2007 hearing before the House Agriculture Committee,
officials and agencies and representatives of foreign
may send one or more inspectors to a country or facility of
FDA’s chief food officer, David Acheson, responded to a
countries as meeting standards established by the Secretary an exporter of seafood imported to the United States. The
question that the agency theoretical y has the authority to
for conducting inspections” under the FFDCA (recognition
inspection will assess the practices used in connection with
require equivalency for imports but that FDA’s situation is
for such inspections could be limited to specific
the farming, cultivation, harvesting, preparation for market,
significantly more complex than USDA’s.... [The
commodities or food types); and under § 109 (accreditation transportation of the seafood; technical assistance may be
Government Accountability Office] had suggested in 1998
of third-party certifying agents), whereby a foreign
provided for such activities. The Secretary, coordinating
that border inspections alone were ineffective, but that
government may be eligible to be a qualified certifying
with the Secretary of Commerce, shall prepare an
FDA lacks the authority to mandate equivalency.”
agent.
inspection report, which will also be provided to the
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However, FDA has visited certain importing countries at
Before requiring certification under § 109, (see above), the
exporter who will be given 30 days to provide a rebuttal or
their invitation to conduct such reviews, suggesting that
Secretary must establish a process for a country or
comments to HHS.
current authority does not bar the Secretary from
territory to demonstrate that its controls are adequate to
conducting such assessments.
ensure that a food destined for the United States is safe.
FSIS has import equivalency authority, in that most meat,
The Secretary cannot require a certification for a food from
poultry, and processed egg products may only be imported
a country or territory that has made such a demonstration.
from countries that have demonstrated to FSIS that they
The application of these certification requirements must be
maintain regulatory protections for specified products that
consistent with U.S. international obligations.
are equivalent to the U.S. system (34 in March 2008). The
United States accepts FDA-regulated products from any
country. The FDA may detain or refuse admission to
imported products based on physical inspections, the
appearance of a violation of the FFDCA, or an import alert.
In 2007, FDA issued an import alert with respect to illegal
drug residues in specific seafood products from China,
requiring that importers demonstrate through testing that
illegal residues are absent.
Obama Administration: Mr. Taylor’s testimony stated
that, “FDA plans to increase inspection of foreign facilities,
but we are concerned that the House bill’s foreign
inspection mandate may not result in the best use of FDA’s
resources, in light of the approximately 200,000 registered
foreign facilities and the high cost of overseas inspections.
We think we can achieve cost-effective oversight of
imports by working with foreign governments, using the
bill’s new tools for import oversight, supporting strong
third-party inspections, and increasing targeted, risk-based
foreign inspections.”
FDA FOREIGN OFFICES
The FFDCA neither prohibits nor requires the
Dedicated Foreign Inspectorate (§ 208)
Foreign Offices of the Food and Drug
establishment of FDA field offices in other countries. FDA
Administration (§ 308)
reports that it is establishing offices in China, Latin America, Amends FFDCA § 704 (in the General Authority chapter)
India, Europe, and the Middle East, and was implementing a
to require the Secretary to establish and maintain a corps
The Secretary is required, in consultation with the
Memorandum of Agreement with China, in order to
of inspectors dedicated to inspecting foreign food facilities.
Secretaries of State and Homeland Security and the United
coordinate food safety activities.
This corps is to be staffed and funded at a level to assist the States Trade Representative, to establish FDA offices in
Secretary to achieve the frequency of inspections for food
foreign countries selected by the Secretary, to assist the
facilities described in this Act.
appropriate governmental entities of those countries
regarding measures to provide for the safety of food and
other FDA-regulated products exported by those countries
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to the United States. FDA activities may include the
conduct of risk-based inspections of such products, and
supporting such inspections by the governmental entity.
The Secretary shal report to Congress by October 1,
2011, with respect to the selection of specific countries,
the progress of the established offices in assisting those
foreign governments, and plans to establish additional
foreign offices. Clarifies that nothing in this provision shall
affect the Secretary’s authority to issue public notifications
under other circumstances.
OTHER LABORATORY PROVISIONS
Several national networks of laboratories are currently in
Plan and Review of Continued Operation of Field
Integrated Consortium of Laboratory Networks (§
operation. None is explicitly authorized in law. Existing
Laboratories (§ 209)
203)
networks include: the Laboratory Response Network
(LRN), run by CDC and federal and state partner groups to The House bill contains no provision comparable to the
The Secretary of Homeland Security, in consultation with
conduct public health testing during emergencies; the Food integrated consortium provision in S. 510. § 209 does
the Secretaries of HHS and USDA and the EPA
Emergency Response Network (FERN), coordinated by
require the Secretary to submit, to Congress and the
Administrator, shall maintain an agreement whereby
FDA; and the National Animal Health Laboratory Network, Comptroller General, a reorganization plan at least 90 days
relevant laboratory network members: (1) agree on
coordinated by USDA.
prior to terminating or consolidating any of the 13 field
common laboratory methods to facilitate information
laboratories responsible for analyzing food that are
sharing regarding animal health, agriculture, and human
Obama Administration: Its FY2010 budget requested an operated by FDA’s Office of Regulatory Affairs, or
health; (2) identify the means by which each laboratory
increase in the number of chemical laboratories under
terminating or consolidating any of the 20 district offices
network member could work cooperatively to optimize
FERN through cooperative agreements, and to invest in
with responsibility for food safety. This section also subjects national laboratory preparedness and provide surge
FDA high-volume laboratories for better sample analyses
such a reorganization plan to the requirements of the
capacity during emergencies; and (3) engage in ongoing
and faster testing. The administration proposed retaining
Congressional Review Act (5 U.S.C. §§ 801-808), which
dialogue and build relationships to support a more effective
the FY2010 level for FY2011.
establishes a special set of expedited or “fast track"
and integrated response during emergencies. The Secretary
legislative procedures, primarily in the Senate, through
of Homeland Security shal publish and report biennial y to
which Congress may enact joint resolutions disapproving
Congress on the progress of this integrated consortium.
agencies' final rules.
FALSE OR MISLEADING REPORTING TO FDA
FFDCA § 301delineates prohibited acts under the law, one
False or Misleading Reporting to FDA (§ 210)
No comparable provision.
of which is “With respect to any device, the submission of
any report that is required by or under this Act that is false
Expands the FDA-regulated products covered by this
or misleading in any material respect.” [§ 301(q)(2)].
prohibited act to include a “food, drug, or biological
product.”
FDA SUBPOENA AUTHORITY
The FFDCA provides authority for issuing subpoenas under Subpoena Authority (§ 211)
No comparable provision.
certain specified conditions. For example, in the course of
Expands subpoena authority by permitting the FDA
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an investigation or hearing leading to either civil penalties
Commissioner to issue subpoenas for witnesses and “the
or withdrawal of approval for violations of the law related
production of records and other things” for the purpose of
to drug applications under §§ 335(b) and 335(c), the
any hearing, investigation, or other proceeding on a
Secretary is authorized, among other things, to issue
violation of the FFDCA. This section contains extensive
subpoenas requiring attendance of witnesses and
language on the timing of compliance and service of a
production of evidence. Similar authorities are provided
subpoena, among other things.
regarding violations related to devices under § 333(f), and
regarding debarment proceedings for certain drug
applications and for food imports (i.e., preventing entry of a
food import), under § 335(a).
WHISTLEBLOWER PROTECTION
A variety of federal and state measures have been adopted
Whistleblower Protections (§ 212)
Employee Protections (§ 402)
to protect so-called whistleblowers, or those employees
who disclose information about illegal or improper activity,
Creates a new FFDCA § 911, “Protections for Employees
Creates a new FFDCA § 1012 prohibiting food businesses
general y at their place of employment. Many federal
Who Refuse to Violate, or Who Disclose Violations of,
from discharging or otherwise discriminating against an
employees, for example, are covered by the Whistleblower
This Act or Section 351 of the Public Health Service Act.”
employee who provides or causes to be provided
Protection Act (P.L. 101-12). The FFDCA itself contains no
Extensive language here makes it illegal to “discharge,
information relating to violations of the FFDCA; who
such language regarding a private employee who must, or
demote, suspend, threaten, harass, on in any other manner
testifies, assists, or participates in a proceeding on such a
willingly provides, information related to an FDA-related
discriminate against an employee in the terms and
violation; or who refuses to participate in an activity
product.
conditions of employment” if such an employee provides
reasonably believed to violate the act. Contains extensive
information on a food, relating to a possible violation of the (but different from House) language on the procedures for
FFDCA or the Public Health Service Act.
treating and protecting whistleblowers.
See “Jurisdiction” above for § 213 of H.R. 2749 regarding extraterritorial jurisdiction.
STATE AND LOCAL FOOD SAFETY ROLES AND TRAINING
Although federal agencies such as the FDA and FSIS have
Support for Training Institutes (§ 214)
Improving the Training of State, Local, Territorial,
national responsibility for food safety under their respective
and Tribal Food Safety Officials (§ 209)
authorizing statutes, state and local food safety agencies
Requires the Secretary to provide financial and other
(usually located within health, agriculture, or environment
assistance to appropriate entities to establish and maintain
Creates a new FFDCA § 1011 which requires the Secretary
departments) have long played major, and in some cases
at least one university-affiliated institute to train federal,
to set standards and administer training and education
lead, roles, with responsibility for illness surveillance,
state and local officials in food protection activities.
programs for employees of state, local, territorial, and tribal
response to local outbreaks, and inspection and oversight
food safety authorities relating to their responsibilities
of food safety and local public health laws in restaurants and
under the FFDCA, and authorizes the Secretary to enter
grocery stores. Often these activities may be conducted in
into examination, testing, and investigations partnerships
collaboration, or under contract, with federal authorities.
with such officials and their employees.
Notable examples include the Grade A Pasteurized Milk
The Secretary shall coordinate with USDA’s extension
Ordinance and the National Conference of Interstate Milk
activities of the National Institute of Food and Agriculture
Shipments (where federal authorities collaborate with state
(NIFA) in advising producers and smal processors of new
authorities and the milk industry to ensure the safety of
requirements under this act. Also, the Secretary, within 180
milk shipped in interstate commerce), the National Shellfish
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Sanitation Program (a federal-state program to ensure the
days of enactment, shal enter into agreements with the
safety of shel fish), and FDA-state contract inspection
Secretary of Agriculture to provide competitive training
agreements (where states conduct facility inspections for
and technical assistance grants, through NIFA, for farmers,
FDA).
small food processors, and small fruit and vegetable
merchant wholesalers, in accordance with § 405 of the
Currently no specific legislative language authorizes support
Agricultural Research, Extension, and Education Reform
for a training institute. FDA does provide funding to state
Act of 1998 (AREERA), as established by this act (see
and local agencies through various grants and cooperative
below). There are authorized to be appropriated for new
agreements to help them conduct such activities as food
FFDCA §1011 such sums as necessary for FY2011-FY2015.
defense, laboratory improvements, and food safety training;
this funding totaled approximately $11.4 million in FY2008
Creates a new AREERA § 405, “National Food Safety
and was in addition to an estimated $8 million states
Training, Education, Extension, Outreach and Technical
received for FDA contracts to conduct food inspection that
Assistance Program.” The Secretary of Agriculture shall,
year. See Stronger Partnerships for Safer Food: An Agenda for
through NIFA, award competitive grants to carry out the
Strengthening State and Local Roles in the Nation’s Food Safety
program authorized above, as specified. Priority shall be
System, at http://www.rwjf.org/.
given to projects for smal and medium-sized farms,
beginning farmers, social y disadvantaged farmers, smal
processors, or smal fresh fruit and vegetable merchant
wholesalers. Grants are limited to terms of not more than
three years. Eligible entities are (1) a state cooperative
extension service; (2) a federal, state, local, or tribal agency,
a nonprofit community-based or non-governmental
organization, or an organization representing owners and
operators of farms, smal food processors, or smal fruit
and vegetable merchant wholesalers that meet specified
requirements; (3) an institution of higher education (as
defined) or a foundation maintained by such institution; (4)
a collaboration of 2 of more eligible entities; or (5) other
entities as determined by the Secretary. Grants may be
made to projects involving more than one state. The
Secretary may issue best practices or other guidelines
based on findings from this grant program. There are
authorized to be appropriated for new AREERA § 405 such
sums as necessary for FY2011-2015.
Enhancing Food Safety (§ 210)
Subsection (a) of this section replaces FFDCA § 1009,
regarding grants to states for inspections. New language
would authorize grants to states, localities, territories,
Indian tribes, and certain non profit entities, to be used for:
undertaking food safety examinations, inspections and
investigations; training to the Secretary’s standards for
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conducting such activities; and building laboratory capacity,
among other things. Sets out eligibility and application
requirements and procedures; authorizes appropriation of
such sums as necessary for grants from FY2011-FY2015.
Requirements for eligible entities are specified, including
maintenance of effort with respect to grantee funding
contributions. Also, the Secretary shal measure the status
and success of each grant program, based on information
provided by recipients of how grant funds were spent and
the status of their efforts.
Subsection (b) of this section requires the Secretary and
the CDC Director (in consultation with other groups) to
designate five “Integrated Food Safety Centers of
Excel ence” at selected state health departments to serve
as resources for federal, state, and local public health
professionals. Authorizes the appropriation of such sums as
necessary to carry out this provision.
BISPHENOL A (BPA) (See also “Bisphenol A (BPA)” section of this report.)
Bisphenol A (BPA) is used to produce certain types of
Bisphenol A in Food and Beverage Containers (§
No comparable provision.
plastic, including food containers. In the United States and
215)
elsewhere, scientific disagreement about the possibility of
human health effects that may result from BPA exposure
Requires the Secretary to notify Congress by December
through food and water has led to conflicting regulatory
31, 2009 on whether available scientific data support “a
decisions regarding the safety of food containers, especial y
determination that there is a reasonable certainty of no
those intended for use by infants and children.
harm, for infants, young children, pregnant women, and
adults, for approved uses” of plastics made with BPA in
BPA-containing PC polymers and epoxy resins used in food
food and beverage containers. If such a determination
containers—such as baby bottles and infant formula cans,
cannot be made for any use, the Secretary must inform
respectively—are regulated by FDA as food contact
Congress on what actions will be taken to protect public
substances. Applicable FDA regulations are at 21 CFR §§
health.
177.1580, 175.300(b)(3)(viii), 177.1440, and 177.2280. A
conclusion of safety by FDA conflicted with earlier findings
by one panel of scientific advisors, and was later challenged
by a second panel. These events have prompted some to
question FDA’s process for the assessment of health risks.
(See also CRS Report RS22869, Bisphenol A (BPA) in Plastics
and Possible Human Health Effects.
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LEAD IN CERAMICS
Pursuant to its FFDCA authority, FDA regulates food
Lead Content Labeling Requirement for Ceramic
No comparable provision.
contact surfaces as wel as food. The FDA has standards
Tableware and Cookware (§ 216)
regarding the leaching of lead from ceramics that are to be
used for food. These are at “Compliance Policy Guide
Would deem ceramic tableware and cookware misbranded
(CPG) Sec. 545.450 Pottery (Ceramics); Import and
under the FFDCA if it includes a glaze or decorations
Domestic—Lead Contamination” (CPG 7117.07).
containing lead for an intended functional purpose, unless
either: it and its package bears statement: “This product is
made with lead-based glaze consistent with FDA guidelines
for such lead”; or [sic] the product is in compliance with
FDA requirements applicable to ornamental and decorative
ceramic ware. Further requires the Secretary to educate
consumers on the safety of ceramic ware for food use.
PROVISIONS ACCORDING TO SECTIONS IN S. 510 THAT HAVE NOT ALREADY BEEN PRESENTED, IN NUMERICAL ORDER
INTENTIONAL ADULTERATION AND DOMESTIC FOOD DEFENSE
Intentional adulteration of foods can occur due to
Hazard Analysis, Risk-Based Preventive Controls,
Protection Against Intentional Adulteration (§ 106)
terrorism or out of economic motivation. Examples of the
Food Safety Plan, Finished Product Test Results
Subsection (a) of this section establishes a new FFDCA §
latter include findings in early 2007 of melamine in pet food
from Category 1 Facilities (§ 102)
420, requiring the Secretary, within 18 months of
ingredients from China. Melamine—apparently added to
boost the ingredients’ protein readings—sickened or killed
Subsection (c) of this section establishes a new FFDCA §
enactment, in coordination with the DHS and in
consultation with USDA, to promulgate regulations to
many dogs and cats in North America. The ingredients
418C, Food Defense, requiring the owner, operator, or
subsequently were found in some hog, chicken, and fish
agent of a facility to develop and implement a written food
protect against the intentional adulteration of food subject
to this act. Regulations shall apply only to food: (1) for
feed. Although a risk assessment by FDA and USDA
defense plan before introducing any shipment of food into
indicated the problem posed virtual y no risk to humans,
interstate commerce. Lists required elements of the plan,
which the Secretary has identified clear vulnerabilities; and
(2) that is in bulk form rather than final packaging. To make
melamine turned up again in 2008 in milk products, milk-
including an assessment to identify conditions and practices
derived ingredients, and finished food products containing
that may permit a hazard to be intentionally introduced, a
such determinations, the Secretary shal conduct
milk from China.
description of preventive measures to minimize such risks
vulnerability assessment of the food system (including
and of corrective actions to be taken if necessary, and
consideration by DHS), considering uncertainties, risks,
FFDCA § 801(h) and (i), regarding imports and exports,
other elements.
costs, benefits, available mitigation strategies, and other
require the Secretary to increase the number of import
factors. This section shal not apply to food produced on
inspections, giving greatest priority to the detection of
Defines “hazard” for the purposes of this section.
farms, except for milk. Failure to comply with the
intentional adulteration of food, and to improve
Authorizes the Secretary to require by regulation or
requirements of this subsection is prohibited.
information management systems and develop rapid
guidance the adoption of preventive measures for specific
Subsection (b) of this section requires the Secretary, within
detection methods to serve this purpose. FDA’s current
product types; al ows for alternative measures to be
one year of enactment, to issue appropriate guidance
food regulations do not specifically address intentional
approved by the Secretary; contains a number of
regarding the requirements of this section, and authorizes
contamination of foods. FDA has published some guidance
reassessment, plan revision, recordkeeping, and records
the Secretary, in coordination with the Secretaries of DHS
documents regarding protection of the food supply from
access requirements similar to those that facilities must
and USDA, to issue guidance documents related to
intentional contamination. The agency also has an internal
follow under this section of the bill when developing and
protection against intentional food adulteration. These
work group on intentional economic adulteration and
implementing hazard prevention plans for unintentional
guidance documents and the vulnerability assessment of the
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conducted, on May 1, 2008, a public meeting on the issue.
contamination.
food system may require limited distribution due to
national security concerns. The Secretary will periodically
There is currently no statutory requirement for the
review required regulations and guidance required by this
development of a comprehensive agriculture and food
section, and update them if needed.
defense strategy. There are, however, other examples of
required, comprehensive, quadrennial reviews of this type.
National Agriculture and Food Defense Strategy (§
The Quadrennial Defense Review is perhaps the best-
108)
known example. The Implementing Recommendations of
Within one year of enactment, the Secretary and the
the 9/11 Commission Act of 2007 (P.L. 110-53) requires
Secretary of Agriculture, and in consultation with the
the Secretary of the Department of Homeland Security
Secretary of Homeland Security, shal prepare a National
(DHS) to routinely conduct a Quadrennial Homeland
Agriculture and Food Defense Strategy, to be submitted to
Security Review, beginning in FY2009. The Pandemic and
relevant congressional committees and made public on
Al -Hazards Preparedness Act (P.L. 109-417, December,
USDA and HHS websites (in a manner consistent with
2006) requires the Secretary of HHS to routinely prepare a
national security interests). The strategy shall include an
quadrennial National Health Security Strategy and
implementation plan and a research agenda, and be
implementation plan, beginning in 2009.
consistent with the National Incident Management System;
“In November 2002, Congress passed legislation creating
the National Response Framework; the National
[DHS]. Among its responsibilities is overall coordination of
Infrastructure Protection Plan; the National Preparedness
critical infrastructure protection activities....In June 2006,
Goals; and other relevant national strategies. The strategy
the Bush Administration released a National Infrastructure
must be revised at least every four years. The strategy shall
Protection Plan. This Plan presents the process by which
describe the process by which HHS, DHS, and USDA will
the Department of Homeland Security intends to identify
achieve a set of goals laid out in this act, and evaluate the
those specific assets most critical to the United States,
progress made by federal, state, local, and tribal
across al sectors, based on the risk associated with their
governments towards achieving those goals. The act lists 17
loss to attack or natural disaster, and then to prioritize
specific goals, covering preparedness, detection, emergency
activities aimed at maximizing the reduction of those risks
response, and recovery.
for a given investment.” (CRS Report RL 30153, Critical
Food and Agriculture Coordinating Councils (§ 109)
Infrastructures: Background, Policy, and Implementation, by
John D. Moteff.) At present, DHS has identified several
Requires the Secretary of Homeland Security, in
critical infrastructure and key resources sectors, including
coordination with the Secretaries of HHS and Agriculture,
“Agriculture and Food.” For each sector, a Government
within 180 days of enactment and annual y thereafter, to
Coordinating Council and a (private) Sector Coordinating
report on the activities of the Food and Agriculture
Council have been established to share data and best
Government Coordinating Council and the Food and
practices, and to support risk-based planning.
Agriculture Sector Coordinating Council, regarding their
progress in facilitating public-private partnerships;
With regard to building domestic capacity, in general,
facilitating information exchange; developing best practices
requirements in this section are not explicit in current law,
for coordinated preparedness and response; and means to
but the Secretary would not be prohibited from
protect the U.S. economy and public health in the event of
undertaking these assessments and reporting the findings.
a food or agricultural incident.
FDA has initiated a number of activities focusing on
Building Domestic Capacity (§ 110)
economic adulteration of foods and other products it
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regulates, including the establishment of an internal working
Establishes a number of assessment and reporting
group.
requirements regarding domestic capacity to prevent or
address food safety threats, as follows:
Within two years of enactment, the Secretary (in
coordination with USDA and DHS) must report to
Congress regarding measures to promote food safety and
supply chain security, and prevent foodborne illness
outbreaks, covering certain identified areas. In preparing
the initial report, the Secretary shall describe ways to
improve laboratory capability and capacity, information
systems, risk assessment systems for food, and include an
analysis of FDA’s handling of foodborne outbreaks during
the five years prior to enactment that involved fruits and
vegetables that are raw agricultural commodities, as defined
in FFDCA § 201(r).
HHS and USDA shall, biennially, submit to Congress a joint
food safety and food defense research plan, which may
include studying the long-term health effects of foodborne
illness. The plan shall include a list and description of
projects conducted during the previous two-year period,
and the plan for projects to be conducted in the fol owing
two years.
HHS shall, annually, submit to Congress an evaluation of
the effectiveness of each HHS-administered program. The
evaluation will assess each program’s effectiveness in
achieving “legislated intent, purposes, and objectives,” and
will include recommendations for consolidation and
elimination to reduce duplication and inefficiencies. The
report will be made publicly available. (Note: The language
of this provision is not limited to food safety programs.)
Not later than one year after enactment, the Secretary shal
conduct a study of issues associated with developing and
implementing a program that requires “unique identification
numbers” for each food facility registered with FDA and for
each broker that imports to the United States. A report to
Congress on “unique identification numbers” is due within
15 months after enactment.
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SANITARY TRANSPORTATION OF FOOD
FFDCA § 416, regarding sanitary transportation practices
No comparable provision.
Sanitary Transportation of Food (§ 111)
for food, was established in § 7202 of the Safe, Accountable,
Flexible, Efficient Transportation Equity Act: A Legacy for
Requires the Secretary, within one year of enactment, to
Users (SAFETEA-LU), P.L. 109-59, August, 2005. The law
promulgate regulations described in FFDCA § 416(b), which
requires the Secretary to promulgate applicable regulations,
say, “The Secretary shall by regulation require shippers,
but does not state a deadline for doing so.
carriers by motor vehicle or rail vehicle, receivers, and
other persons engaged in the transportation of food to use
sanitary transportation practices prescribed by the
Secretary to ensure that food is not transported under
conditions that may render the food adulterated.” Requires
FDA conduct a study of the transportation of food for U.S.
consumption, addressing certain issues including an
examination of the “unique needs of rural and frontier
areas with regard to delivery of safe food.”
FOOD ALLERGY AND ANAPHYLAXIS MANAGEMENT
FFDCA § 403(w) requires food products that contain any
No comparable provision.
Food Allergy and Anaphylaxis Management (§ 112)
of the eight most common food allergens (defined in
Requires the Secretary, within one year of enactment and
FFDCA § 201(qq)) to declare their presence on the food
in consultation with the Secretary of Education, to develop,
label. Noncompliant food is deemed misbranded. This
and make available to local educational agencies (LEAs),
requirement was established by the Food Allergen Labeling
guidelines to develop plans for individuals to manage the
and Consumer Protection Act of 2004 (P.L. 108-282). The
risk of food allergy and anaphylaxis in schools and early
act focused specifically on food labeling and did not address
childhood education programs. The voluntary guidelines
food allergy and anaphylaxis (a severe, whole-body allergic
shall address specified elements, as follows: (1) parental
reaction) management in schools or elsewhere. FDA has
obligation to provide the school with information regarding
announced it is developing a long-term strategy to assist
a student’s food allergy and risk of anaphylaxis; (2) an
manufacturers to better inform food allergic consumers
individual plan created with the parent and tailored to each
about the allergens in their products.
student with a documented risk for anaphylaxis; (3)
communication strategies between schools and emergency
medical services; (4) strategies to reduce the risk of
exposure to anaphylactic causative agents in classrooms and
common areas for affected students; (5) training and
education for school and program personnel, parents, and
children; (6) authority and training of program personnel to
administer epinephrine when the nurse is not immediately
available, and the availability of epinephrine for this
purpose; (7) as part of an individual plan, a plan that
addresses the response to an anaphylactic incident in a
child engaged in extracurricular programs; (8) maintenance
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of information for each administration of epinephrine to a
child, and prompt notification of parents; and (9) other
elements the Secretary determines to be necessary. An
individual management plan developed pursuant to this
section shall be considered an education record for the
purpose of the Family Educational Rights and Privacy Act of
1974 (FERPA) [20 U.S.C. § 1232g]. Nothing in this section
or the guidelines developed by the Secretary shall be
construed to preempt state law, including any state law
regarding whether students at risk for anaphylaxis may self-
administer medication.
Authorizes the Secretary to award non-renewable food
al ergy management incentive grants for up to two years to
assist LEAs with adoption and implementation of the
voluntary food allergy management guidelines. LEAs must
provide matching funds of at least 25% of the amount of the
grant and report to the Secretary with information on how
the grant money was spent and the status of
implementation of the guidelines. In awarding grants under
this subsection, the Secretary shall give priority to LEAs
with the highest percentages of economically disadvantaged
children, as defined by § 1124(c) of the Elementary and
Secondary Education Act of 1965 [20 U.S.C. § 6333(c)].
The grant program is authorized for $30 million for
FY2011, and such sums as may be necessary for each of
four succeeding fiscal years. Though the guidelines
developed by the Secretary are voluntary, the Secretary is
authorized to enforce an agreement by an LEA to
implement such guidelines as a condition of receipt of a
grant authorized by this section.
Note: This provision authorizes grant-making by the
Secretary of HHS to assist LEAs in implementing food
allergy and anaphylaxis management guidelines. Because any
individual management plans developed pursuant to this
funding would be considered as education records, such
records may not be available for disclosure to the Secretary
of HHS.
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VITAMINS AND MINERALS, ANABOLIC STEROIDS
FFDCA section 413 [21 U.S.C. 350b] requires that
No comparable provision.
New Dietary Ingredients (§ 113)
manufacturers and distributors of dietary supplements who
wish to market dietary supplements that contain “new
Amends 21 U.S.C. 350b. Requires the Secretary to notify
dietary ingredients" (those not marketed in the United
the U.S. Drug Enforcement Agency, as specified, if s/he
States in a dietary supplement before October 15, 1994)
determines that the information in a new dietary ingredient
notify FDA about these ingredients.
notification submitted under this section for an article
purported to be a new dietary ingredient is inadequate to
establish that a dietary supplement containing such article
will reasonably be expected to be safe because the article
may be, or may contain, an anabolic steroid or an analogue
of an anabolic steroid. Requires the Secretary to publish
guidance that clarifies when a dietary supplement ingredient
is a new dietary ingredient, among other things.
SEAFOOD (See also “Hazard Analysis and Risk-Based Preventive Controls” section of this report.)
The National Shel fish Sanitation Program (NSSP) is the
No comparable provisions.
Requirements for Guidance Relating to Post
federal/state cooperative program recognized by FDA and
Harvest Processing of Raw Oysters (§ 114)
the Interstate Shel fish Sanitation Conference (ISSC; see
next paragraph) for the sanitary control of shel fish
Creates for the Secretary and GAO certain requirements
produced and sold for human consumption. The purpose of
(see below) triggered when the FDA issues—related to the
the NSSP is to promote and improve the sanitation of
post harvest processing of raw oysters—(1) guidance,
shellfish (oysters, clams, mussels and scallops) moving in
regulation, or suggested amendment to the NSSP’s Model
interstate commerce through federal/state cooperation and
Ordinance; or (2) guidance or regulation relating to the
uniformity of state shellfish programs. Participants in the
Seafood HACCP Program (21 CFR parts 123 and 1240).
NSSP include agencies from shel fish producing and non-
Not later than 90 days prior to issuance, requires the
producing States, FDA, EPA, NOAA, and the shellfish
Secretary to submit to Congress a report on the projected
industry.
public health benefits, cost of compliance, feasibility of
The ISSC is a voluntary national organization of state
implementation, and certain other topics. This requirement
shellfish regulatory officials that provide guidance and
does not apply to the guidance described in 103(h)
counsel on matters for the sanitary control of shel fish. The
(Updating Guidance Relating to Fish and Fisheries Products
ISSC has adopted formal procedures for state
Hazards and Controls, discussed below). This requirement
representatives to review shel fish sanitation issues and
is waived if the Secretary issues a guidance that is adopted
develop regulatory guidelines. Following FDA concurrence,
as a consensus agreement between federal and state
these guidelines are published in revisions of the NSSP
regulators and the oyster industry, acting through the ISSC.
Model Ordinance.
Not later than 30 days after the Secretary issues a
FDA’s Seafood HACCP Program regulations are articulated
proposed regulation or guidance described above, requires
in 21 CFR parts 123 (fish and fishery products) and 1240
the GAO to (1) review and evaluate the Secretary’s report
(control of communicable diseases).
and report its findings to Congress, (2) compare such
proposed regulation or guidance to similar regulations or
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S. 510 (Senate-passed)
FDA’s Fish and Fisheries Products Hazards and Controls
guidance for other regulated foods, including a comparison
Guidance was published by the agency to assist processors
of risk, and (3) evaluate the impact of post harvest
of fish and fishery products in the development of HACCP
processing on the competitiveness of the U.S. oyster
plans, which are required under regulations at 21 CFR 12.
industry domestically and in international markets.
Despite FDA’s stated intention to update the guidance
Requires any report prepared under the section to be
every 2 to 3 years, the most recent edition is dated June
made public.
2001.
Updating Guidance Relating to Fish and Fisheries
Products Hazards and Controls (§103, part) Requires
the Secretary to update the Fish and Fisheries Products
Hazards and Control Guidance to take into account
advances in technology since its previous publication.
PORT SHOPPING
FFDCA section 801(n) provides FDA with the authority to
No comparable provision.
Port Shopping (§ 115)
help prevent “port shopping,” whereby importers of
refused goods try to import through another port when
Until the Secretary promulgates a final rule that implements
refused entry at one port. The provision authorizes FDA to
the amendments made by section 308 of the Bioterrorism
require refused food to be marked with the statement
Act of 2002, requires the Secretary to notify the Secretary
“UNITED STATES: REFUSED ENTRY.” This authority was
of Homeland Security of instances of import refusals under
enacted in section 308 of the Bioterrorism Act of 2002
FFDCA section 801(a) (Imports; list of registered foreign
(P.L. 107-188)
establishments; samples from unregistered foreign
establishments; examination and refusal of admission) to
alert U.S. Customs and Border Protection and prevent
imports refused at one port from being admitted by
another port.
See “Jurisdiction” row of this table for § 116 of S. 510 regarding alcohol.
FOOD DECONTAMINATION AND DISPOSAL
Depending on the type(s) of contaminant and the type(s) of
No comparable provision.
Decontamination and Disposal Standards and Plans
food involved, several federal agencies and a variety of laws
(§ 208)
may be involved in various steps in the process of
decontamination, disposal, and/or remediation following an
Requires the Administrator of the Environmental
agriculture or food emergency. In addition to agencies that
Protection Agency (EPA), in coordination with the
provide scientific and technical assistance—particularly EPA,
Secretaries of HHS, DHS, and USDA, to provide support
and various agencies in DHS, HHS, and USDA—the Federal
and technical assistance to state, local, and tribal
Emergency Management Agency (FEMA) may be involved if
governments in preparing for, assessing, decontaminating,
the incident is sufficiently large in scope, and the Federal
and recovering from an agriculture or food emergency.
Bureau of Investigation may be involved if it resulted from a
Activities shall include: (1) the development and
deliberate act. In addition, state authorities may play a
dissemination of standards and protocols; (2) jointly
developed model plans for the decontamination of
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leading role, and may seek technical and other assistance
individuals, equipment, and facilities following an intentional
from appropriate federal agencies. Several Emergency
incident, and the disposal of large quantities of infected or
Support Function annexes in FEMA’s National Response
contaminated animals, plants, or food products; and (3) the
Framework provide insights into the possible roles and
conduct of annual exercises, consistent with the mandated
coordination of various federal agencies in response to an
DHS national exercise program. Based on findings from
agriculture or food emergency.
exercises, model plans shal be updated at least biennial y.
The development of standards and plans shall be
prioritized, considering: the highest-risk biological,
chemical, and radiological threat agents; agents that could
cause the greatest economic devastation to the agriculture
and food system; and agents that are most difficult to clean
or remediate.
IMPORT CERTIFICATION (See also “Use of Third Parties for Imports and for Laboratory Accreditation” and “Food Imports” sections of this report, and “Laboratory
Accreditation” and “Inspection of Foreign Facilities” rows of this table.)
The steady increase in food imports, a result of
Certification and Accreditation (§ 109, part)
Authority to Require Import Certifications for Food
globalization and consumer desire for a wider variety of
(§ 303)
foods year-round, has generated growing concerns about
Amends FFDCA § 801 by authorizing the Secretary to
whether current federal programs sufficiently ensure the
require, as a condition of granting admission for an
Amends FFDCA § 801 by authorizing the Secretary to
safety of these imports. Most of the recent debate has
imported food article, that a “qualified certifying entity
require certification or other assurance of the safety of an
included extensive discussion about how to improve
provide a certification that the article complies with
article of food imported or offered for import, and to deny
current import safeguards, within resource constraints, and
specified requirements” of the FFDCA. This requirement is
entry to any food offered for import that does not meet
without unduly restraining free trade.
to take effect on or after three years from date of
such a requirement. The Secretary may base such a
enactment. However, the Secretary must only require such
requirement on public health considerations, including risks
Current law does not explicitly authorize, or require, any
certification in the following situations:
associated with the food or its place of origin. Such
certification of imports, and whether FDA has what is often
certification shall be used for designated food imported
cal ed “equivalence authority" has been a matter of debate
• For food imported from a particular country, territory,
from countries with which the FDA has an agreement to
(also see below). Regardless, it does not have a program
or region, where the Secretary finds based on scientific
establish a certification program. Certifying entities—those
like that of FSIS, which many consider to be a form of
risk-based evidence that the government controls there are who may provide certification or assurances—include an
certification. Under the FMIA and PPIA, no foreign
inadequate and that such certification would assist in
agency or a representative of the government of the
establishment can ship its products to the United States
determining the admissibility of the food;
country from which the article of food at issue originated,
until FSIS has determined that the establishment’s country
• For a food type for which there is scientific evidence
as designated by such government or the Secretary; or such
has a meat and/or poultry safety program that provides a
that there is a particular risk that presents a threat of
other persons or entities accredited to conduct audits,
level of protection that is at least equivalent to the U.S.
serious adverse health consequences or death and that
pursuant to § 808, as established by this act, to provide
system. FSIS visits the exporting country to review its rules
such certification would assist in determining whether the
such certification or assurance. The Secretary may require
and regulations, meets with foreign officials, and
article poses such risk; or
periodic renewal, or determine that a current certification
accompanies them on visits to establishments. In addition,
is not valid. The Secretary shall provide for electronic
FSIS operates a reinspection program at 150 import houses
• For an article imported from a particular country or
submission of required certifications. Certifying agents who
located near approximately 35 border entry points. Some
territory, if the Secretary has an agreement with that
make false statements shall be subject to criminal fines or
have suggested that the FDA program should operate more government providing for such certification.
imprisonment pursuant to 18 U.S.C. § 1001. If the
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like that of FSIS, although they acknowledge the difficulties
The Secretary, in coordination with the Commissioner for
Secretary determines that the food safety systems of a
and resource demands of attempting to regulate many
Customs and Border Protection, shall provide for the
foreign country or region do not meet the requirements of
more different types of foods from many more countries of electronic submission of certifications. A certification may
this section, the Secretary shall, to the extent practicable,
origin.
take the form of a statement that the article, or the facility
identify such inadequacies and a means for the country or
region to notify the Secretary of subsequent improvements.
Obama Administration: Dr. Hamburg’s testimony
or farm “that manufactured, processed, packed, held, grew,
Amendments made by this section shall not limit the
expresses support for relying not only on foreign
harvested, sorted, or transported” it, complies with FFDCA Secretary’s authority to conduct inspections of imported
governments for international inspections but also having
requirements as specified by the Secretary, or take any
food or to take such other steps as the Secretary deems
the flexibility to explore use of an accreditation system and
other form specified by the Secretary including a listing of
appropriate to determine the admissibility of imported
audit the performance of accredited third parties.
certified facilities or other entities.
food.
Before requiring certification, the Secretary must establish a
process for a country or territory to demonstrate that its
controls are adequate to ensure that a food destined for
the United States is safe. The Secretary cannot require a
certification for a food from a country or territory that has
made such a demonstration. The application of these
certification requirements must be consistent with U.S.
international obligations.
A qualified certifying entity must notify the Secretary
whenever it cancels or suspends the certification of a
facility or other listed entity. Imports required to have but
lacking certification are to be denied entry. Finally, this
section is not to limit the Secretary’s authority to conduct
random import inspections, issue import alerts for
detaining products, or take other steps necessary to
determine imports’ admissibility. Other § 109 provisions
regarding qualified certifying entities are discussed in a later
section, “Third-Party Accreditation.”
PRIOR NOTICE OF IMPORTS
FFDCA § 801(m) requires the Secretary to establish, by
No comparable provision.
Prior Notice of Imported Food Shipments (§ 304)
regulation, procedures and requirements by which an
importer shall give FDA prior notice of shipments of food
Amends the list of elements that must be provided in the
intended for importation, in order that FDA can make
notice required under FFDCA § 801(m) by adding the
determinations regarding the admissibility of the food. The
identity of “any country to which the article has been
FFDCA stipulates certain required data elements that must
refused entry.” Within 120 days of enactment, the
be included in the notice, including the country from which
Secretary shall publish an interim final rule implementing
the food originated, and the country from which the food is
this amendment, which shal take effect 180 days after the
shipped. In November 2008, FDA published a final
date of enactment.
regulation to implement the current authority. The final
rule does not require that information be provided
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S. 510 (Senate-passed)
regarding refusal of an article of food by another country.
FOREIGN CAPACITY BUILDING
Current law would not prohibit the development of the
No comparable provision.
Building Capacity of Foreign Governments with
plan proposed by this section of S. 510 (right).
Respect to Food (§ 305)
Implementation of certain elements of such a plan may be
authorized under: (1) FFDCA § 803, which authorizes an
Requires the Secretary, within two years of enactment, to
HHS Office of International Relations to, among other
develop a comprehensive plan to expand the technical,
things, reach agreements with other governments regarding
scientific, and regulatory capacity of foreign governments,
practices and standards; and (2) PHS Act § 307, authorizing
and their respective food industries, from which foods are
col aborations with foreign governments for the purposes
exported to the United States. In developing the plan, the
of research and education regarding health-related matters.
Secretary shal consult with the Secretaries of Agriculture,
State, Treasury, Homeland Security, and Commerce, the
U.S. Trade Representative, representatives of the food
industry, appropriate foreign government officials, and non-
governmental organizations that represent the interests of
consumers, and other stakeholders. The plan shal include,
as appropriate: (1) recommendations for bilateral and
multilateral arrangements and agreements, including
provisions for responsibility of exporting countries to
ensure the food safety; (2) provisions for electronic data
sharing; (3) provisions for mutual recognition of inspection
reports; (4) training of foreign governments and food
producers on U.S. food safety requirements; (5)
recommendations to harmonize requirements under
Codex Alimentarius; and (6) provisions for multilateral
acceptance of laboratory methods and detection
techniques. This section does not apply to dietary
supplements.
SMUGGLED FOOD
The FFDCA does not appear to address or to define the
No comparable provision.
Smuggled Food (§ 309)
term “smuggled food,” although Chapter VIII of the act
covers imports and exports.
Requires the Secretary, within 180 days of enactment, in
consultation with designated officials in the Department of
Homeland Security, to develop and implement a strategy
“to better identify smuggled food and prevent its entry into
the United States.” Contains notification requirements
regarding smuggled food, defined here as “any food that a
person introduces into the United States through
fraudulent means or with the intent to defraud or mislead.”
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S. 510 (Senate-passed)
DETERMINATION OF BUDGETARY EFFECTS (“PAY-AS-YOU-GO”)
The Statutory Pay-As-You-Go Act of 2010 (Title I of P.L.
No comparable provision.
Determination of Budgetary Effects (§405).
111-139) created a budget enforcement tool aimed at
preventing, or at least discouraging, increases in the net
Note: The House bill was passed by the chamber before the This section complies with requirements in the Statutory
deficit that could arise from the enactment of direct
enactment of the Statutory Pay-As-You-Go Act. Thus, it
Pay-As-You-Go Act by referencing the CBO score for this
spending and revenue legislation. The statutory PAYGO
does not have any reference to paygo or the CBO score
measure. The CBO score has a zero net direct spending
process does not apply to discretionary spending, which is
like the Senate measure, which originated later.
estimate (mandatory spending), and thus no effect on
provided in annual appropriations acts.
statutory paygo. (See “CBO Estimate of the Statutory Pay-
Nonetheless, there is a CBO score of the House bill, and it
As-You-Go Effects for Senate Amendment 4715 in the
The budgetary effects of PAYGO measures are determined
estimates direct revenues from civil penalties of $10 million
Nature of a Substitute to S. 510, FDA Food Safety
by statements inserted into the Congressional Record by
over 5 years, and $2 billion of potential discretionary
Modernization Act,” November 19, 2010, at http://www.
the chairmen of the House and Senate Budget Committees
spending over 5 years (in addition to spending offset by
cbo.gov/ftpdocs/119xx/doc11970/s510.pdf.)
and referenced in the measures. As a general matter, the
new user fees). See Congressional Budget Office, “Cost
statements are expected to reflect cost estimates prepared
Estimate of H.R. 2749, Food Safety Enhancement Act of
This direct spending score is unrelated to the potential for
by the Congressional Budget Office (CBO). If this
2009,” July 24, 2009, at http://www.cbo.gov.
higher future discretionary appropriations that may be
procedure is not followed, then the budgetary effects are
needed to implement the law. (E.g., $1.4 billion over 5
determined by the Office of Management and Budget
years as estimated in “Congressional Budget Office Cost
(OMB).
Estimate of S. 510,” August 12, 2010, at http://www.cbo.
gov/ftpdocs/117xx/doc11794/s510.pdf.) The budget impact
If OMB determines after a congressional session ends that a
of changes in discretionary appropriations would be
cumulative violation of PAYGO has occurred for the
determined by discretionary budget limits and allocations
budget year, then sequestration may occur, which is an
placed on future appropriations acts, and decisions by
across-the-board cut in nonexempt direct spending
future appropriations committees.
programs. (See CRS Report R41157, The Statutory Pay-As-
You-Go Act of 2010: Summary and Legislative History.)
Source: Table created by CRS staff based on the text of the House-passed and the Senate-passed bills (H.R. 2749 and S. 510).
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Food Safety in the 111th Congress: H.R. 2749 and S. 510
Author Contact Information
Renée Johnson, Coordinator
Vanessa K. Burrows
Specialist in Agricultural Policy
Legislative Attorney
rjohnson@crs.loc.gov, 7-9588
vburrows@crs.loc.gov, 7-0831
Sarah A. Lister
Harold F. Upton
Specialist in Public Health and Epidemiology
Analyst in Natural Resources Policy
slister@crs.loc.gov, 7-7320
hupton@crs.loc.gov, 7-2264
Erin D. Williams
Jim Monke
Specialist in Public Health and Bioethics
Specialist in Agricultural Policy
ewilliams@crs.loc.gov, 7-4897
jmonke@crs.loc.gov, 7-9664
Acknowledgments
This report was originally written by Geoffrey S. Becker, Specialist in Agricultural Policy.
Congressional Research Service
100