Food Safety in the 111th Congress:
H.R. 2749 and S. 510
Renée Johnson
Specialist in Agricultural Policy
October 7, 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
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 one of a number of microbial
pathogens and other contaminants. 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. 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 the 111th Congress, several food safety bills have been introduced, and wide-ranging legislation
(H.R. 2749) has passed the House. The Senate also has reported a comprehensive bill (S. 510).
Both of these 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 has oversight of
most meat and poultry). The bills would generally expand or modify existing FDA authorities
rather than create a new food safety structure or authorities. H.R. 2749 is a revised version of
H.R. 759, and was amended and approved by a House Energy and Commerce subcommittee on
June 10, 2009. The full committee further amended and approved H.R. 2749 on June 17, 2009,
and the full House approved the bill on July 30, 2009, with a number of additional amendments
intended to satisfy the concerns of agricultural interests. The Senate Health, Education, Labor,
and Pensions Committee amended and approved S. 510, and later reported it in December 2009.
In mid-July 2010, potential amendments to the bill were being discussed, aimed at addressing
issues of continued interest to various Senators. In August 2010, a group of Senate leaders
released a manager’s amendment to S. 510. Senate floor action has been held up by objections
about the projected cost of the bill, as well as attempts to further amend it.
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 rarely visits
food manufacturing and other facilities to check sanitary and other conditions. In response, the
bills would require (although in different ways) 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.
The 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 do so voluntarily.
Major portions of the bills are devoted to more scrutiny of food imports, which account for an
increasing 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-passed bill and Senate amendment 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............................................................................................................ 1
Existing Food Safety Legal and Regulatory Landscape.......................................................... 2
Administration Views............................................................................................................ 5
Congressional Response........................................................................................................ 6
Legislative Overview ...................................................................................................... 6
Overview of Major Provisions......................................................................................... 7
Selected Issues .......................................................................................................................... 10
Registration ........................................................................................................................ 11
Record-Keeping.................................................................................................................. 12
Hazard Analysis and Risk-Based Preventive Controls.......................................................... 13
Performance Standards........................................................................................................ 14
On-Farm Safety Standards; Safety of Produce ..................................................................... 15
Mitigating Effects on Small Business and Farming Operations ............................................ 17
Targeting of Inspections ...................................................................................................... 22
Use of Third Parties for Imports and for Laboratory Accreditation....................................... 25
Mandatory Recall Authority ................................................................................................ 27
Notification of Contaminated Products, and Product Tracing ............................................... 29
Foodborne Illness Surveillance and Outbreak Response ...................................................... 30
Criminal Penalties............................................................................................................... 32
Food Imports ...................................................................................................................... 35
Bisphenol A (BPA).............................................................................................................. 37
Paying for Food Safety with User Fees................................................................................ 38
Tables
Table 1. Crosswalk of Food Safety Provisions in H.R. 2749 (House-Passed) and S. 510
(Manager’s Amendment of August 12, 2010) ........................................................................... 9
Table 2. FDA Food-Related Inspection Data, FY2004-FY2011.................................................. 23
Table 3. Criminal Penalties for Violations of FFDCA § 303(a)................................................... 33
Table 4. FDA Direct Appropriations for Foods, FY2005-FY2011 .............................................. 39
Table 5. Types of Fees in House-Passed H.R. 2749 and Senate Manager’s Amendment to
S. 510 .................................................................................................................................... 41
Table 6. Comparison of Annual Fees in House-Passed H.R. 2749 and Senate Manager’s
Amendment to S. 510............................................................................................................. 42
Table 7. Comparison of Periodic Fees in House-Passed H.R. 2749 and Senate Manager’s
Amendment to S. 510............................................................................................................. 43
Appendixes
Appendix. Comparison of Provisions in H.R. 2749 (House-Passed) and S. 510 (Senate
Manager’s Amendment) with Current Law............................................................................. 45
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Contacts
Author Contact Information ...................................................................................................... 86
Acknowledgments .................................................................................................................... 86
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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 one 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
Food Safety Incidents
Food safety-related incidents frequently heighten public and media scrutiny of the U.S. food
safety system.5 Large recalls of FSIS-regulated meat and poultry products (including ground beef)
due to findings of E. coli O157:H7, Listeria, and other problems occur each year.6 In addition, in
recent years, several large multi-state foodborne 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 the bacterium E. coli O157:H7.
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.
5 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.
6 For updates on meat and poultry recalls and alerts, see the FSIS website: http://www.fsis.usda.gov/fsis_recalls/
index.asp.
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Attention shifted to 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 subsequently were found in some hog, chicken, and fish 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 2008, more than 1,400 persons in 43 states, the District of Columbia, and Canada were found
to be infected with the same unusual strain of bacteria, Salmonella Saintpaul. Officials first
suspected fresh tomatoes as the vehicle, but later tests confirmed 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 contamination incidents.
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.
According to the U.S. Centers for Disease Control and Prevention (CDC), 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, CDC noticed a spike in cases of infection with Salmonella Enteritidis, a strain
commonly associated with shell eggs, which are regulated by FDA.7 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.8 In July 2009, FDA had published a long-awaited egg safety
regulation, which became effective in July 2010 as the outbreak was well underway.9 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.10
Existing Food Safety Legal and Regulatory Landscape
Federal responsibility for food safety rests primarily with FDA and USDA. 11 The FDA is
responsible for ensuring that all domestic and imported food products—except for most meats
7 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.
8 FDA, “Salmonella Enteritidis Outbreak in Shell Eggs,” http://www.fda.gov/Food/NewsEvents/WhatsNewinFood/
ucm222684.htm.
9 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.
10 Alicia Mundy and Bill Tomson, “Egg Inspectors Failed to Raise Alarms,” The Wall Street Journal, September 10,
2010.
11 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.
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and poultry—are safe, nutritious, wholesome, and accurately labeled. USDA’s Food Safety and
Inspection Service (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, on the
same day in 1906, both the Pure Food and Drugs Act and the Meat Inspection Act. The former
was passed to address the widespread marketing of intentionally adulterated foods, and its
implementation was assigned to USDA’s Bureau of Chemistry. The latter law was passed to deal
with unsafe and unsanitary conditions in meat packing plants, and implementation was assigned
to a different USDA agency, the 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.12
There has been discussion over time regarding whether this dispersal of food safety
responsibilities has been problematic, 13 or whether a reorganization would divert time and
attention from other fundamental problems in the system. Neither the House-passed bill nor the
Senate amendment 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.
Both the House and Senate proposals 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 § 301.14 Persons who commit prohibited acts are subject to criminal
and civil penalties.
12 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.
13 See 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.
14 21 U.S.C. § 331.
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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 means “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, introduction of adulterated food into commerce, adulteration of food that is in commerce, or
receipt and delivery of adulterated food in commerce are prohibited. (See “Prohibited Acts” below.) Adulteration is defined in
FFDCA § 402(a), 21 U.S.C. § 342(a), as fol ows:
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 shal 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, introduction of misbranded food into commerce, misbranding of food that is in commerce, or
receipt and delivery of misbranded food in commerce are 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.
Person: FFDCA § 201(e), 21 U.S.C. § 321(e), defines person to include an individual, partnership, corporation, or 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 CFR 123.3(k)].”
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 introduction of adulterated or misbranded food into commerce;
adulteration or misbranding of food that is in commerce; or receipt and delivery of adulterated or misbranded food in commerce
are 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.15 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 Obama, in a March 14, 2009, weekly radio address, called the food safety system a
“hazard to public health.” 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 Administration was taking, under existing authorities, to
improve government safeguards.17 The group released a one-year progress report in July 2010.
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.”18
To date, the Obama Administration has not provided recommended language for changes in
authorizing statutes. The Administration declared its support for H.R. 2749 in its official
Statement of Administration Policy on the bill.19 In a July 2010 statement, the Administration
further urged the Senate to complete its work on S. 510.20 In addition, Administration officials
have testified on aspects of the legislation. Testimony 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, 2009.21
15 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.
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/
FSWG_Key_Findings.pdf.
18 The White House, Statement by the President on Food Safety, July 7, 2010, http://www.whitehouse.gov/the-press-
office/statement-president-food-safety.
19 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.
20 The White House, Statement by the President on Food Safety, July 7, 2010, http://www.whitehouse.gov/the-press-
office/statement-president-food-safety.
21 Dr. Hamburg’s comments were based on an earlier version of H.R. 2749, i.e., prior to markup by the subcommittee;
Mr. Taylor’s were based on the version reported by the full Energy and Commerce Committee (H.Rept. 111-234).
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In October 2009 testimony on the Senate bill, FDA Commissioner Margaret 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.22 (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. Several
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 2007.23 The 110th Congress adopted some amendments to current programs 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.
Legislative Overview
In the 111th Congress, nearly a dozen food safety bills, several of them comprehensive, have been
introduced. However, the major vehicle in the House has been H.R. 2749 by Representative
Dingell. This bill was amended and approved by the Subcommittee on Health of the House
Energy and Commerce Committee on June 10, 2009; by the full committee on June 17, 2009
(H.Rept. 111-234, July 29, 2009); and by the full House on July 30, 2009.24
22 October 22, 2009, testimony of FDA Commissioner Margaret Hamburg before the Senate Committee on Health,
Education, Labor, and Pensions.
23 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.
24 Two other comprehensive House bills have been H.R. 875 by Representative DeLauro, a blueprint for a new,
independent Food Safety Administration (FSA), separated from the current FDA but still within HHS, which would
(continued...)
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In the Senate, the principal bill was originally introduced as S. 510 by Senator Richard Durbin.
The HELP Committee amended and approved the bill on November 18, and reported it (without a
written report) on December 18, 2009. During the summer of 2010, potential amendments to the
bill were being discussed, aimed at addressing issues of continued interest to various Senators.
These include a proposal by Senator Dianne Feinstein to phase out the use of bisphenol-A (BPA)
in food packaging25 and a proposal by Senator Jon Tester to exempt small facilities from certain
requirements, if they make less than $500,000 in annual sales and if the majority of those sales
are sold directly to qualified end-users. 26
On August 12, 2010, several members of the Senate HELP Committee, including its 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.27
Following the release of the proposed amendment, Senate floor action was widely anticipated.
However, as of mid-September 2010, further action on the measure had stalled. Senator Tom
Coburn has objected to the projected cost of the measure.28 Although the Senate manager’s
proposal (referred to as the “Senate amendment” in this report) does not include either of the
changes proposed by Senators Tester and Feinstein, versions of these could be offered as
amendments if the proposal is considered by the full Senate. In addition, a bill approved by the
Senate Judiciary Committee on September 23, 2010 (S. 3767, introduced by Senator Patrick
Leahy), which would increase penalties for persons who knowingly distribute tainted food
products, could also be offered as an amendment.
Overview of Major Provisions
Both H.R. 2749 and S. 510 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 the House and Senate bills seek to address many
of the same 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. 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 its widely acknowledged funding and staffing constraints, and no explicit requirement for
(...continued)
operate a comprehensive new food safety program (but would not include the meat and poultry inspection programs
operated by FSIS); and H.R. 1332 by Representative Costa, which is similar in design to the version of the Senate bill
originally introduced by Senator Durbin (S. 510).
25 Alan K. Ota, “Food Safety Bill Held Up By Split Over Fine Lining,” CQ Today Online News, July 21, 2010. See also
CRS Report RS22869, Bisphenol A (BPA) in Plastics and Possible Human Health Effects.
26 Press release, Senator Tester, “Updated Food Safety amendment protects small producers,” September 24, 2010,
http://tester.senate.gov/Newsroom/pr_092410_foodsafety.cfm. See also CRS Report RL34612, Food Safety on the
Farm: Federal Programs and Legislative Action.
27 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/.
28 Senator Tom Coburn, Unanimous Consent Request, S. 510, Congressional Record, daily edition, vol. 156
(September 23, 2010), pp. S7394-S7397.
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the frequency of inspections, the agency rarely visits food manufacturing and other facilities to
check sanitary and other conditions.
Both 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 are similar conceptually to the
so-called hazard analysis and critical control point, or HAACP, 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.
The bills seek to increase the frequency of plant inspections, taking into account the risks posed
by specific foods or processors. 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 bill requires 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 bills differ somewhat on how such authority might
be applied, and on related requirements for notification when adulterated or misbranded food
threatens public health.
The 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 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 by an
accrediting body recognized by FDA; again, the House and Senate bills differ in detail on how to
accomplish these objectives. The bills 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 bills is how the proposed program changes would be funded.
Specifically, H.R. 2749 would institute a new $500 annual facility registration fee that would help
offset the cost of various FDA activities in the bill; a similar fee is not included in S. 510. 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
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penalties for food-related violations under the FFDCA would increase by $10 million over the
same period.29 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.”30 Despite higher offsetting fee revenues proposed in the House bill, CBO scored
higher net federal costs for the House bill than for the Senate amendment due to higher costs in
the House bill for FDA activities (principally related to facility inspections) that would not be
supported by fees.
Table 1 provides a crosswalk of the House and Senate provisions. A comparison of key
provisions in the House-passed bill and Senate amendment with current law is provided in the
Appendix at the end of this report.
Table 1. Crosswalk of Food Safety Provisions in H.R. 2749 (House-Passed) and S. 510
(Manager’s Amendment of August 12, 2010)
Sections in H.R. 2749
Sections in S. 510 (manager’s
Topic
(House-passed)
amendment)
Food Facility Registration
101 102
Requirements (not including
imported foods)
Record-keeping requirements
102 (HACCP), 106 (access), 107
101 (access), 103 (HACCP), 204
(traceability), 204 and 205 (imports)
(traceability), 301 and 307 (imports)
Record-keeping; Records
106, 107, 205
101
Access and Inspection
Hazard Analysis and Risk-Based
102
103, 114 (seafood)
Preventive Controls and Food
Safety Plans
Performance Standards
103
104
Standards for Produce, other
104 105
Raw Agricultural Commodities
Targeting of Inspection
105, 207
201, 306
Resources
Third Party Accreditation
307
109
Laboratory Accreditation,
110, 209
202, 203
Testing
Recall Authority
102 and 108 (facility and importer recall
103 (facility recall plans), 107 (fees),
plans), 105 (inspection frequency), 111
201 (inspection frequency), 206
(mandatory recall authority), 204 (fees)
(mandatory recall authority)
Notification; Reportable Food
111 and 112 (notification and Reportable
211 (Reportable Food Registry)
Registry
Food Registry)
29 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.
30 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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Sections in H.R. 2749
Sections in S. 510 (manager’s
Topic
(House-passed)
amendment)
Food Traceability
102 (HACCP), 107 (tracing system),
110 (report on traceback capability),
206(unique facility identifier)
204 (tracing system), 302 (importer
tracing plans)
Foodborne Illness Surveillance
121, 122
205
and Education
Administrative Detention of
132 207
Food
Intentional Adulteration and
102
106, 108, 109, 110
Domestic Food Defense
State and Local Food Safety
214 209,
210
Roles and Training
Whistleblower Protection
212
402
Other Enforcement Provisions
131 (Procedures for seizure), 133
—
(including provisions not
(Authority to prohibit or restrict the
comparable between House
movement of food), 134 (Criminal
and Senate bills)
penalties), 135 (Civil penalties), 210 (False
or Misleading Reporting to FDA), 211
(Subpoena Authority)
Import Certification
109
303
Inspection of Foreign Facilities
105, 207
306
Foreign Supplier Verification
204, 205, 206, 136
301
Expedited Imports
113
302
FDA Foreign Offices
208
308
Other importer provisions
202 (Country of Origin Labeling)
304 (Prior Notice of Imported Food
(including provisions not
Shipments), 305 (Building Capacity of
comparable between House
Foreign Governments with Respect
and Senate bills)
to Food), 115 (Port Shopping), 309
(Smuggled Food)
HHS-USDA Jurisdiction
4, 5, 6, 213
403, 116, 404
Funding and Fees
101, 108, 203, 204
107, 401
Research
123
210
Miscellaneous provisions
114 (Infant Formula), 201 (Food
111 (Sanitary Transportation of
(including provisions not
Substances General y Recognized As
Food), 112 (Food Al ergy and
comparable between House
Safe), 215 (Bisphenol A in Food and
Anaphylaxis Management), 113 (New
and Senate bills)
Beverage Containers), 216 (Lead Content
Dietary Ingredients), 208
Labeling Requirement for Ceramic
(Decontamination and disposal
Tableware and Cookware)
standards and plans)
Source: Table prepared by the Congressional Research Service based on the text of H.R. 2749, as passed by the
House, and the August 2010 manager’s amendment to S. 510 in the Senate.
Selected Issues
The following sections provide a discussion of the key provisions in H.R. 2749 as passed by the
House and the Senate manager’s amendment to S. 510. Unless otherwise noted, the House bill
provisions discussed in this section refer to provisions in the House-passed H.R. 2749, and the
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Senate provisions refer to provisions in the Senate manager’s amendment (“amendment”) to S.
510, released August 12, 2010. 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 amendment (§ 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 amendment 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 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 amendment would not change the current exemptions from the registration
requirement for farms, restaurants, retailers, and certain types of nonprofit food establishments
and fishing vessels. The amendment would not impose registration fees.
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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.31
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
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.” (Drafters of the bill view the removal of the “reasonable belief”
requirement as authority to access 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.
31 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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The Senate amendment (§ 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 amendment 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
that are likely to be affected in a similar manner, but would need to believe that 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 safeguards, which is based on a
law first written early the last century, is primarily reactive. By and large, the agency’s statute and
regulations spell out the reasons a food article is to be considered adulterated or 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. 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. 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
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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.32
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.33
Legislative Proposals
The House-passed bill and Senate amendment (§ 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 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
amendment contains additional requirements regarding available FDA guidance documents for
seafood (§ 114).
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.”34 The
committee added that regulators like the FDA, USDA, and the Environmental Protection Agency
32 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.
33 National Advisory Committee on Microbiological Criteria for Foods, Hazard Analysis and Critical Control Point
Principles and Application Guidelines, adopted August 14, 1997.
34 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.
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(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.35
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.36
Legislative Proposals
The House bill and Senate amendment both include language on performance standards (§ 103
and § 104, respectively). Although differing in detail, the House-passed bill and Senate
amendment 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 amendment conditions the
issuance of standards, requiring them “[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 amendment 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. From this point, viewpoints diverge. 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 relied on the latter “carrot” approach that, in the view of some critics, is no
longer effective. It also could be argued that numerous existing laws and regulations already
35 Ibid, p. 17.
36 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
CRS Report RL32922, Meat and Poultry Inspection: Background and Selected Issues.
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impose restrictions, both direct and indirect, on producers of food commodities, which effectively
meet food safety objectives—and also involve significant compliance costs. These restrictions
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.37 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
2002.38 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
officials access to these records if a food is suspected of being adulterated and presenting a
serious health threat.39
FDA’s general approach has been not to impose mandatory on-farm safety standards or
inspections of agricultural facilities.40 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; they are advisory and not legally enforceable.41 In July 2009, the
Obama Administration released new draft guidances on three specific types of produce: tomatoes,
melons, and leafy greens.42 However, FDA’s final rule (effective July 2010) requiring shell egg
producers to implement an-farm safety measures to prevent contamination of eggs by Salmonella
Enteritidis (SE) is one example of FDA regulatory activity on-farm.43
37 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.”
38 P.L. 107-188; 21 U.S.C. 350(d).
39 21 U.S.C. 350c and 21 U.S.C. § 374. FDA has 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 Appropriations Subcommittee on
Agriculture, Rural Development, Food and Drug Administration, and Related Agencies, Appropriations for 2008,
Hearings, Part 5, p. 479.
40 The FDA advisory panel acknowledged that the agency “conducts only limited inspections of food-producing farms,
except in emergencies.” FDA Science and Mission at Risk: Report of the Subcommittee on Science and Technology.
41 Sources: FDA, Guide to Minimize Microbial Food Safety Hazards for Fresh Fruits and Vegetables, October 26,
1998, at http://www.cfsan.fda.gov/~dms/prodguid.html; and Guide to Minimize Microbial Food Safety Hazards of
Fresh-cut Fruits and Vegetables, February 2008, at http://www.fda.gov/Food/
GuidanceComplianceRegulatoryInformation/GuidanceDocuments/ProduceandPlanProducts/ucm064458.htm.
42 FDA, “Draft Guidance for Industry: Guide to Minimize Microbial Food Safety Hazards of Tomatoes; Availability;’’
FDA, “Draft Guidance for Industry: Guide to Minimize Microbial Food Safety Hazards of Melons;” and FDA, “Draft
Guidance for Industry: Guide to Minimize Microbial Food Safety Hazards of Leafy Greens; Availability” (74 Federal
Register 38437-38440, August 3, 2009). See also FDA, “FDA Issues Draft Guidances for Tomatoes, Leafy Greens and
Melons,” July 31, 2009, http://www.fda.gov/Food/FoodSafety/Product-SpecificInformation/FruitsVegetablesJuices/
FDAProduceSafetyActivities/ucm174086.htm.
43 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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Legislative Proposals
Several provisions in the in the House-passed bill and Senate amendment 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 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. These regulations could set forth
procedures and practices that the Secretary determines to be reasonable to prevent known or
reasonably foreseeable biological, chemical, and physical hazards, including natural ones, that
may be intentionally or unintentionally introduced. The 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.”
The Senate amendment 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 amendment would encourage coordination with USDA and would require, as appropriate,
coordination with state agricultural agencies when enforcing standards. Enforcement may be in
the form of audit-based verification systems or other inspection methods. The amendment
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.
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,
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organic, direct-to-market, and sustainable farming operations; and small livestock operations.44 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.
Several provisions in the House-passed bill and Senate amendment 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). In addition, both bills would require the issuance
of updated good agricultural practices, among other bill provisions that could potentially affect
small businesses and farming operations. These include facility registration requirements (§ 101
of the House-passed bill; § 102 of the Senate amendment); records access and/or inspection
requirements (§ 106 of H.R. 2749; § 101 and § 204 of the Senate amendment); food traceability
requirements (§ 107 of H.R. 2749; § 204 of the Senate amendment); hazard analysis and risk-
based preventive controls (§ 103 of the Senate amendment); targeting of inspection resources
(Section 201 of the Senate amendment); 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, as well as the discretion of the HHS Secretary.
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
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 gross cash income (or sales receipts), adjusted gross income (AGI),
numbers of employees, or other measures. 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.45 Under these definitions, USDA data indicate that 22% of all crop and livestock
producers were considered to be small commercial farms. The share of small 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
44 For information, see CRS Report RL34612, Food Safety on the Farm: Federal Programs and Legislative Action.
45 Robert A. Hoppe, “U.S. Farm Structure: Declining—But Persistent—Small Commercial Farms,” Amber Waves,
USDA, September 2010, http://www.ers.usda.gov/AmberWaves/September10/Features/USFarm.htm; and USDA,
USDA, Small Farms in the United States: Persistence Under Pressure, EIB-63, February 2010,
http://www.ers.usda.gov/publications/eib63/. Based on 2007 survey data.
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farms is roughly 10% of all growers in this category.46 Small business definitions for farms,
established by the Small Business Administration (SBA), also are based on annual sales receipts
but vary considerably from USDA’s definitions: among most crop producers, SBA defines as a
small business those who make no more than $750,000 in sales per year.47 By these standards,
more farms would be considered small businesses, with up to one-half of all crop and livestock
producers defined as small.48
Elsewhere in farm legislation, adjusted gross income (AGI) is 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 periodic omnibus farm bill,49
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. 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 indicate that farms with less than $500,000 AGI account for the vast
majority (more than 95%) of farm numbers.50
For food processors, 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. Among
most food processors, a small business is defined by the SBA as a business with no more than 500
employees.51 By this definition, nearly all (97%) of all food manufacturers would be considered
small businesses based on U.S. Census Bureau data.52
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
“employing fewer than 500 persons.”53 Accordingly, available data indicate that as many as 84%
of businesses that make juice would be not be covered by the HAACP requirements.54 Very small
businesses would also be exempt, and so defined 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.”55 Producers of “raw
46 Ibid., Figure 3.
47 Small Business Size Regulations, Title 13 C.F.R. Part 121.
48 Based on data on farms that make up to $1 million. USDA survey data are not published for this increment.
49 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.
50 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.
51 Small Business Size Regulations, Title 13 C.F.R. Part 121.
52 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/.
53 Hazard Analysis And Critical Control Point (HAACP) Systems, Title 21 C.F.R. Part 120.
54 U.S. Census Bureau, 2007 County Business Pattern. Data for “Frozen Fruit, Juice, and Vegetable Manufacturing.”
55 Hazard Analysis And Critical Control Point (HAACP) Systems, Title 21 C.F.R. Part 120.
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agricultural ingredients of juice,” such as fruit and vegetable growers, would not be covered by
the HAACP requirements.
Legislative Proposals
Although both the House-passed bill and the Senate amendment 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.
The House-passed bill contains additional provisions that are intended to address potential effects
of the food safety requirements on small, organic, direct-to-market, and sustainable farming
operations, among other related provisions. 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)).
Initially, S. 510 was 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 require 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).
The Senate amendment includes additional provisions intended to address the potential effects of
the food safety requirements on small business and other farming operations. These include
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”; and assurances that any new
regulations do not conflict with or duplicate other federal policies and standards, and that they
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 considerations in the Senate amendment, Senator Jon Tester has stated
that he intends to offer further amendments to address small farm interests if the Senate food
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safety measure reaches the Senate floor in the 111th Congress.56 Senator Tester first announced in
spring 2010 that he planned to introduce two amendments to the Senate committee-reported bill,
S. 510.57 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 exempt
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.”
These amendments were not ultimately included in the Senate manager’s amendment.
In September 2010, Senator Tester, along with Senator Kay Hagan, announced an updated version
of this amendment.58 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 in regulation). Under this
proposed amendment, qualified facilities would not be subject to the facility registration
requirements under FFDCA § 415; instead they would be required to submit to HHS relevant
documentation showing that they have implemented preventative 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 miles59 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 Tester-Hagan amendment also includes other
clarifying language with respect to the exemption for direct farm marketing and sales. The
provision further would require that HHS conduct a study of the food processing sector, in
conjunction with USDA.
Many farm groups have expressed support for these proposed amendments.60 However, one of the
leading produce industry groups, United Fresh Produce Association (UFPA), is urging 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.61 In addition to
56 Senator Tester press release, “Updated Food Safety Amendment Protects Small Producers,” September 24, 2010,
http://tester.senate.gov/Newsroom/pr_092410_foodsafety.cfm.
57 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).
58 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.
59 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.”
60 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.
61 United Fresh Produce Association, 2010 Issues Brief, http://www.unitedfresh.org/assets/
(continued...)
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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).62 Some consumer groups, including the Consumers Union, have expressed concern
that the proposed amendments would create “too great a loophole” in the food safety
requirements, among other concerns.63
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. Due to the differing laws and circumstances that apply to FSIS,
for example, that 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.64 (See Table 2.)
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.
(...continued)
Issue_Brief_United_Fresh_Produce_Association_2010.pdf.
62 Comments by industry representatives at the UFPA’s 2010 Washington Public Policy Conference, September 15,
2010; Helena Bottemiller, “Group Breaks Ranks on Small Farm Exemptions,” Food Safety News, September 10, 2010.
63 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.
64 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 2. 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.” Numbers for FY2010 are appropriated; for FY2011 are
requested; al others are actual.
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.
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 U.S. may present
less of a health risk than those with less rigorous standards.
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 amendment. 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 amendment 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
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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.
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 amendment 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 amendment 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 amendment 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.
Regarding seafood, the Senate amendment would permit the heads of various agencies to enter
into specified types of agreements to improve seafood safety. In order to target food inspection
resources, the Secretary would be required to coordinate and cooperate with the Secretaries of
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Agriculture and Homeland Security, and would be permitted to consult with any relevant HHS
advisory committee, as appropriate. For foreign seafood, the Senate amendment would permit the
Secretary of Commerce to send inspector(s) to a country or facility of an exporter from which
seafood imported into the United States originates. Such inspector(s) would conduct a specified
assessment of practices and processes used in connection with the farming, cultivation, harvesting
of such seafood. Based on each assessment, the Secretary of HHS, in coordination with the
Secretary of Commerce, would be required to prepare and inspection report, provide it to the
relevant country or exporter, and provide a 30-day period for rebuttal.
The Senate amendment 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.65 FDA may conduct voluntary, on-site assessments of private
accredited laboratories.66 FDA’s own laboratories are accredited and, according to FDA, “the
laboratory industry favors accreditation.”67 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.”68 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.”69
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.”70 In January 2009, FDA
issued a 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.71 The guidance document encouraged importers to
notify the FDA in advance of their submission of a sample to an accredited laboratory, so as “to
65 FDA, Draft Guidance, Guidance for Industry: Submission of Laboratory Packages by Accredited Laboratories (Jan.
2009), hereinafter Draft Guidance.
66 Ibid.
67 Ibid.
68 FDA, Guidance for Industry: Voluntary Third-Party Certification Programs for Foods and Feeds (Jan. 2009).
69 Ibid.
70 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).
71 Draft Guidance.
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discourage importers from withholding bad test results, re-testing, or re-sampling.”72 In January
2009, FDA also issued a final guidance document on voluntary third-party certification programs
for foods 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.73
House and Senate legislative proposals 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.
72 Ibid.
73 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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The Senate amendment (§ 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
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 amendment also contains language regarding revocation of
accreditation and avoidance of conflicts of interest.
Section 202 of the Senate amendment 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 Senate amendment would require the development of model accreditation standards, re-
evaluation of accreditation bodies at least every five years, and submission of laboratory test
results to the FDA unless the Secretary exempts such submission 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. It can also order recalls of unsafe medical devices such as
pacemakers.) GAO and others have contended that these gaps increase the possibility that unsafe
food will not be recovered, and will be consumed.74
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.75 FDA notes, however, that its authority to seize adulterated or
misbranded food may not be practical or effective once a product is in wide distribution. Private
companies rarely fail to order a voluntary recall when problems arise, and some contend that
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.
74 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. See also CRS Report RL34167, The FDA’s Authority to Recall
Products; and CRS Report RL34313, The USDA’s Authority to Recall Meat and Poultry Products.
75 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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The Bush Administration’s November 2007 strategy for food safety called for mandatory recall
authority (for FDA, not FSIS) in cases where firms (whether foreign or domestic) are unwilling to
do so voluntarily or expeditiously. Similarly, President Obama’s Food Safety Working Group
recommends granting FDA the authority to mandate food recalls.76 Significantly, reversing their
earlier opposition, many major food industry groups now endorse legislative proposals to grant
FDA mandatory recall authority.
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 amendment (§ 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 amendment 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.
76 President’s Food Safety Working Group, “Key Findings,” March 14, 2009, http://www.foodsafetyworkinggroup.gov.
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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
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 (such as the melamine
contamination of pet food), it appears that food company representatives were aware of a food
safety problem for a prolonged period of time before notifying FDA.
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.77 Also, the enacted 2008 farm
bill (P.L. 110-246) amends the meat and poultry laws to require that an establishment 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 about 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 the 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 to first 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,
77 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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benefits, and feasibility of adopting such technologies; conduct at least two public meetings; and
conduct one or more pilots.
The House-passed 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
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 amendment (§ 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
amendment 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 amendment (§ 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 amendment 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.78 A foodborne disease outbreak is not defined in law or in regulations. In
78 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.
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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.”79 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.)
The nation’s public health capacity for foodborne illness surveillance and outbreak response is a
mix of significant strengths and significant gaps.80 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
tools used to identify the food associated with an outbreak can be cumbersome. 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.81
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.”82 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 2010.83
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 surveillance systems,
including by 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.
79 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.
80 See CRS Report R40916, Food Safety: Foodborne Illness and Selected Recalls of FDA-Regulated Foods.
81 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.
82 President’s Food Safety Working Group, “Key Findings,” March 2009, http://www.foodsafetyworkinggroup.gov/
ContentKeyFindings/HomeKeyFindings.htm.
83 FDA, “Measuring Progress on Food Safety: Current Status and Future Directions; Public Workshop,” 75 Federal
Register 9232, March 1, 2010.
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The Senate amendment (§ 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.
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 §
301.84 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.
Presently, upon conviction for a misdemeanor violation of the prohibited acts section, a person85
faces the penalties authorized in FFDCA § 303(a).86 These are presented in Table 3. The
maximum criminal penalty for individuals (as adjusted by 18 U.S.C. §§ 3559 and 3571) is
$100,000 if the misdemeanor does not result in death, $250,000 if the misdemeanor results in
death, and/or imprisonment of one year. 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.87
84 21 U.S.C. § 331.
85 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.
86 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).
87 21 U.S.C. § 303(c)(1)-(3). FFDCA § 301(h) prohibits a person from giving a false guaranty to another person that a
(continued...)
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Table 3. 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)
Federal Food, Drug, Violation of FFDCA prohibited
$100,000 if the misdemeanor $200,000 if the offense
and Cosmetic Act
acts provisions, FFDCA § 301
does not result in death,
does not result in death,
(FFDCA) §
$250,000 if the misdemeanor $500,000 if the offense
303(a)(1)
results in death; and/or
results in death
imprisonment of one year
(21 U.S.C. §
333(a)(1))
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
conviction under FFDCA § 303
more than $250,000, or both
(21 U.S.C. §
or a violation committed with
333(a)(2))
the intent to defraud or mislead
Proposed FFDCA §
Knowing violation of certain
Imprisonment for not more
A fine of not more than
303(a)(3), as set
FFDCA prohibited acts
than 10 years or a fine of not $500,000
forth in H.R. 2749
provisions with respect to any
more than $250,000, or both
food that is misbranded or
adulterated
Proposed FFDCA §
Knowing violation of certain
Imprisonment for not more
A fine of not more than
303(a)(3), as set
FFDCA prohibited acts
than 10 years or a fine of not $500,000
forth in S. 3767
provisions with respect to any
more than $250,000, or both
food and with conscious or
reckless disregard of a risk of
death or serious bodily injury
Source: Prepared by CRS.
A violation of the FFDCA’s prohibited acts section is a felony offense if it occurs after a prior
conviction for violating 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.88 The decision to seek criminal sanctions against
individuals and corporations suspected of violating the FFDCA is within the FDA’s discretion.89
(...continued)
food is not adulterated.
88 18 U.S.C. §§ 2, 371.
89 Heckler v. Chaney, 470 U.S. 821 (1985) (holding that “[t]he FDA’s decision not to take the enforcement actions
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”).
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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.”90
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 amendment would not alter the criminal penalties under FFDCA § 303(a). However,
it has been reported that if the measure is considered by the Senate, another bill, S. 3767 (the
Food Safety Accountability Act of 2010, introduced by Senator Patrick Leahy), could be offered
as an amendment. 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.
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.”
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
90 FDA, REGULATORY PROCEDURES MANUAL § 6-5-1 (March 2010), http://www.fda.gov/ICECI/ComplianceManuals/
RegulatoryProceduresManual/ucm176738.htm.
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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 3.
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. 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.91
The FFDCA (at 21 U.S.C. § 381(a)) empowers the 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), is to help 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.92 In 2007
congressional hearings, witnesses testified that 450 inspectors must cover more than 300 ports of
entry.93
Current law does not explicitly authorize, or require, import verification, and whether FDA has
what is often called “equivalence authority”94 has been a matter of debate. Regardless, FDA does
not have a program like that of FSIS. Under the FMIA and PPIA, no foreign establishment can
ship its products to the United States until FSIS has determined that the establishment’s country
91 Additional information is available in CRS Report RL34198, U.S. Food and Agricultural Imports: Safeguards and
Selected Issues.
92 Source: FDA briefing for Senate staff, February 8, 2008. FDA FY2009 budget materials state that 94,743 import
food field exams were conducted in FY2007.
93 See for example hearings held before subcommittees of the House Committee on Energy and Commerce, July 17,
September 26, and October 11, 2007.
94 “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. 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.
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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. 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.
Legislative Proposals
The House-passed bill and Senate amendment 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,
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 amendment (§ 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 amendment (§ 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
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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 bill and the Senate amendment 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 the House bill and the Senate amendment 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
amendment (§ 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.95 FDA’s conclusion in 2008 that BPA use is safe conflicted with findings of
advisory panels. This prompted some to question FDA’s risk assessment process, and its ability to
conduct such assessments competently. 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.96 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.97
95 For additional background information, see CRS Report RS22869, Bisphenol A (BPA) in Plastics and Possible
Human Health Effects.
96 Lyndsey Layton, “No BPA for Baby Bottles in U.S.,” The Washington Post, March 6, 2009.
97 Lyndsey Layton, “Replacing BPA in Cans Gives Foodmakers Fits; FDA Safety Concerns Prompt Scramble to
(continued...)
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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 amendment does not contain a provision regarding BPA. It is reported that Senator
Dianne Feinstein had sought to include in it a provision that would ban BPA in FDA-regulated
food containers, and may instead offer a separate amendment restricting BPA if the manager’s
amendment is considered by the Senate before the end of the 111th Congress.98 A proposed BPA
amendment has not been made public. It could require a ban on BPA in FDA-regulated food
containers (as does S. 593, a bill sponsored by Senator Feinstein), or a phased elimination of the
chemical, or elimination of the chemical from only some types of food containers, or some other
approach.
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 the lack of sufficient funding and staff to carry
out congressionally mandated (and existing) responsibilities to ensure a safe food supply.99
Responding to a request from Democratic leaders of the House Energy and Commerce
Committee, a Science Board subcommittee estimated that, in order to address these deficiencies,
the food-related portion of FDA’s appropriation should be increased by $128 million in FY2009,
$283 million in FY2010, $441 million in 2011, $598 million in FY2012, and $755 million in
2013.100 In fact, congressional appropriators have increased funding for FDA food activities in
recent years.101 (See Table 4.)
(...continued)
Remove the Chemical,” The Washington Post, February 23, 2010.
98 Denise Grady, “In Feast of Data on BPA Plastic, No Final Answer ,” The New York Times, September 7, 2010; and
Ellyn Ferguson, “Egg Recall Helps Spur Efforts to Find Consensus on Food Safety Legislation,” CQ Today Online
News, September 10, 2010.
99 See, e.g., FDA Science Board, FDA Science and Mission at Risk: Report of the Subcommittee on Science and
Technology, November 2007.
100 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.
101 See CRS Report R40792, Food and Drug Administration Appropriations for FY2010.
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Table 4. FDA Direct Appropriations for Foods, FY2005-FY2011
(dollars in millions)
FY2005 FY2006 FY2007 FY2008 FY2009 FY2010 FY2011
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.” Numbers for
FY2010 are appropriated; for FY2011 are requested; al others are actual.
Proposed increases in program spending raise a variety of policy issues. Requests for higher
appropriations always compete with other priorities throughout the federal discretionary budget
(the programs do not operate, like farm support programs, for example, as mandatory
authorizations), 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);102 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 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.
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 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 in 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
102 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.
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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.103
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. In FY2007, in order to make user fee funding more
consistent and reliable, certain annual fees (such as annual registration fees) were enacted.104
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 used fees have reductions for small businesses.
Legislative Proposals
Each major proposal would fund some FDA food safety activities through the collection of user
fees, though the types of fees and details differ. (See Table 5.) The House-passed bill would
authorize higher fees, would carry a higher total price tag, and would mandate more frequent
inspections than the Senate amendment (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 amendment
would collect $241 million.105 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 amendment.106
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 amendment 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
103 See CRS Report RL34334, The Food and Drug Administration: Budget and Statutory History, FY1980-FY2007.
104 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).
105 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.
106 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.
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two tables at the end of this report, 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 6, below. For periodic fees, see Table 7, below.
Table 5. Types of Fees in House-Passed H.R. 2749 and Senate Manager’s Amendment
to S. 510
H.R. 2749, House-passed
S. 510, Manager’s Amendment
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 the CRS based on the text of the House-passed H.R. 2749 and Senate manager’s
amendment to S. 510.
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Table 6. Comparison of Annual Fees in House-Passed H.R. 2749 and Senate Manager’s Amendment to S. 510
H.R. 2749, House-passed
S. 510, Manager’s Amendment
Category
Facility Registration Fee
Importer Registration Fee
VICP 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 annually).
Amounts estimated as specified to cover 100% of the VQIP
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 under
Fees over 30 days past due treated as a claim of the U.S.
Nonpayment
claim of the U.S. Government under 31
new FFDCA § 801(s) may be suspended or
Government under 31 U.S.C., chapter 37, subchapter II (Claims
U.S.C., chapter 37, subchapter II (Claims of cancelled for FFDCA violations; foods are
of the United States Government).
the United States Government).
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 an
None.
Secretary must: (1) publish within 180 days of enactment a
Meetings
annual report on the implementation of
proposed set of guidelines related to the burden of fee amounts
the authority and use of the fee; (2) hold
on smal businesses; (2) submit to Congress, not later than 120
an annual public meeting on how the fees
days after each fiscal year in which fees are assessed, a specified
would be used and collected.
report describing fees assessed and col ected, entities paying
such fees, and their types of business.
Authorization
Such sums as may be necessary for each of Such sums as may be necessary for each of
For FY2010 and each FY thereafter, an amount equal to the
FY2010 through FY2014.
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 safety
Related Restrictions
for FDA’s salaries and expenses (total, not
activities, excluding fees, are less than the preceding year’s
on Fee Collection
just for food) are less than the preceding
appropriations adjusted for inflation, as specified.
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 H.R. 2749 and Senate Manager’s Amendment to S. 510.
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Table 7. Comparison of Periodic Fees in House-Passed H.R. 2749 and Senate Manager’s Amendment to S. 510
H.R. 2749, House-passed
S. 510, Manager’s Amendment
Reinspection and Recall
Export Certification
Category
Fee
Export Certification Fee
Reinspection Fee
Recall Fee
Fee
Who Pays
Facilities that must undergo
Exporters who voluntarily
If subject to reinspection in
If noncompliant with a
Exporters who voluntarily
an additional inspection for
request and receive within
a fiscal year: the responsible recall order under FFDCA
request and receive within
violating the FFDCA; or are 20 days Secretary’s export
party for a domestic facility
§ 412(f) or new § 423: the
20 days Secretary’s export
subject to a food recall.
certification under
(defined in new FFDCA §
responsible party for
certification under
amended FFDCA
415(b)), the U.S. registered
domestic facilities (defined
amended FFDCA
§ 801(e)(4).
agent for a foreign facility,
in new FFDCA § 415(b)), or § 801(e)(4).
or the importer.
the importer.
Fee Amount
Secretary sets fees at a
Secretary sets inflation-
Secretary annual y
Secretary annual y
Fees may cover the cost of
level to fully cover cost of
adjusted fee annually.
establishes fees for facilities
establishes fees to cover
certification.
reinspections and/or recalls.
and for importers so each
100% of estimated cost of
fee covers 100% of the
food recal activities
respective estimated
associated with such order
reinspection-related costs.
performed by the
Secretary.
Fee Amount Cap /
Secretary waives / refunds
Fee may not exceed
The amount of fees
The amount of fees
Fee may not exceed $175
Waiver
fees resulting from
amount reasonably related
collected may not exceed
collected may not exceed
per certification.
inappropriately ordered
to the cost of issuing
$25 million in a given FY,
$20 million in a given FY,
recalls.
certificates.
except that if a domestic
except that if a domestic
facility or importer
facility or importer
becomes subject to a fee in
becomes subject to a fee in
a given year, the Secretary
a given year, the Secretary
may collect it.
may collect it.
Result of Nonpayment
No provision in § 108 of
No provision in § 203 of
Fees over 30 days past due treated as a claim of the U.S.
No provision in § 107 of
bill.
bill.
Government under 31 U.S.C., chapter 37, subchapter II
amendment.
(Claims of the United States Government).
How Funds May Be Used
For recall and reinspection.
For issuing certifications.
For reinspection-related
For food-recall-related
For issuing certifications.
activities.
costs associated with the
recal order, for activities
performed by the
Secretary.
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Food Safety in the 111th Congress: H.R. 2749 and S. 510
H.R. 2749, House-passed
S. 510, Manager’s Amendment
Reinspection and Recall
Export Certification
Category
Fee
Export Certification Fee
Reinspection Fee
Recall Fee
Fee
Required Reports,
None.
None.
Secretary must: (1) publish within 180 days of enactment a
None.
Meetings
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
collected, entities paying such fees, and their types of
business.
Authorization
Such sums as may be
Fees shall be collected in
For FY2010 and each FY thereafter, an amount equal to
No provision in § 107 of
necessary for each of
each FY in an amount equal
the revenue amount determined as specified.
amendment.
FY2010 through FY2014.
to the amount specified in
appropriations acts.
Appropriations-Related
None.
None.
Fees must be refunded if appropriations for FDA’s food
None.
Restrictions on Fee
safety activities, excluding fees, are less than the preceding
Collection
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 H.R. 2749 and Senate manager’s amendment to S. 510.
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Appendix. Comparison of Provisions in H.R. 2749 (House-Passed) and S. 510
(Senate Manager’s Amendment) with Current Law
Background, Applicable Current Law, and
Administration Statements
H.R. 2749 (House-passed)
S. 510 (Manager’s Amendment)
Food Facility Registration Requirements
Changes in Registration of Food Facilities (§ 101)
Registration of Food Facilities (§ 102)
Some assert that registration requirements should be
Amends FFDCA § 415 both to require facilities to register
Amends FFDCA § 415 to require biennial facility registration,
strengthened so that FDA is notified when a firm moves,
annual y, by each December 31, and to pay an annual
with an abbreviated process for registrants whose information
undertakes a new food business, or changes product lines.
registration fee of $500. (This fee is described in more detail
has not changed. Registrants are required to provide additional
Otherwise, the FDA’s records on what facilities are
later in this memorandum.) The Secretary is authorized to
contact information, including an e-mail address and, for foreign
manufacturing and marketing food are continual y out of date, it
suspend the registration of any facility for an FFDCA violation
facilities, the United States agent for the facility. Registrants must
is argued. Others have argued that additional registration
that could result in serious adverse health consequences or
also provide an assurance that the Secretary will be permitted to
requirements would be needlessly intrusive and costly for the
death to humans or animals. Where the Secretary exercises this
inspect the facility. The Secretary is authorized or required to
industry.
discretionary suspension authority, the Secretary must first
suspend and/or reinstate registrations, based on the Secretary’s
provide the facility a notice of intent and opportunity for an
determination that “food manufactured, processed, packed, or
Both domestic and foreign food facilities are required to register informal hearing, after which a suspension order may be written held by a facility registered under this section has a reasonable
with FDA pursuant to FFDCA § 415. Farms, restaurants, other
for finding a violation, with timelines for doing so specified. A
probability of causing serious adverse health consequences or
retail food establishments, and most nonprofit food
suspended registration could be reinstated based on criteria
death to humans or animals” for a facility that “created, caused,
establishments and fishing vessels are excluded from the
published by the Secretary. Places limitations on the Secretary’s
or was otherwise responsible” or “that knew of, or had reason
requirement. Renewal is not required on any periodic basis, but
authority to delegate suspension decisions.
to know of, such reasonable probability.” The bill delineates an
registrants must notify the Secretary in a timely manner of any
appeal process, including a requirement for an informal hearing
relevant changes in their status. FFDCA § 301(dd) designates
Makes failure to register an act of “misbranding” under FFDCA § general y within two business days, and procedures for
failure to register as a prohibited act. FFDCA § 801(l) provides
403.
submission of a corrective action plan and for lifting a
that imported food may not be delivered to the importer,
suspension. The Secretary shal review corrective action plans
owner, or consignee of the article until the foreign facility is
Also amends the information requirements of registrants to
“not later than 14 days after the submission” of such plans. The
registered. FDA does not have explicit authority to require a
include: the name, address, and emergency contact of each
Secretary also shall promulgate regulations regarding suspension
registration fee.
facility being registered; its primary purpose and business
activity, including dates of operation if seasonal; the category of
and reinstatement procedures. If its registration is suspended, a
Obama Administration: The Hamburg and Taylor
food manufactured, processed, packed or held there; al business facility may not import food, or introduce food into interstate
testimonies express support for § 101 of the House bill.
trade names; and the name, address and 24-hour emergency
or intrastate commerce, in the United States. The Secretary’s
contact information of the U.S. distribution agent. Further
authority to suspend registration shall not be delegated to
requires registrants to notify the Secretary of any changes in
anyone other than the FDA Commissioner. The Secretary may
products, function or legal status within 30 days of a change,
require that registration be submitted electronical y, but not
unless otherwise specified by the Secretary, who may cancel a
earlier than 5 years after enactment.
registration that is improperly updated or contains false,
Contains provisions for consideration of smal businesses.
misleading, or inaccurate information, or if the required fee is
Requires the Secretary to issue a ”small entity compliance policy
not paid within 30 days.
guide” setting forth the requirements of such regulations to
Contains extensive language defining what is and is not a facility.
assist smal entities in complying with the registration
A facility is “any factory, warehouse, or establishment (including
requirements and other activities (no later than 180 days after
a factory, warehouse or establishment of an importer) that
the issuance of the regulations under this section).
CRS-45
Food Safety in the 111th Congress: H.R. 2749 and S. 510
Background, Applicable Current Law, and
Administration Statements
H.R. 2749 (House-passed)
S. 510 (Manager’s Amendment)
manufactures, processes, packs or holds food.” Stipulates that a
facility is not a farm, a private residence, a restaurant or other
retail food establishment, a nonprofit establishment that
prepares or serves food directly, or a fishing vessel, and further
clarifies what is meant by these exceptions. Also specifies what a
farm may or may not do to be exempted from facility
registration requirements.
Records Access and Records Inspection
Access to Records (§ 106)
Inspections of Records (§ 101)
Many advocates of reform argue that recordkeeping
Broader than S. 510; amends FFDCA § 414(a) regarding Records Amends FFDCA § 414, which contains one standard (trigger) for
requirements must be strengthened to improve the ability of
Inspection. Although much of the amended language appears
records access, by creating two such standards. The first is
regulators to determine whether firms are complying with the
similar to existing language, several qualifying phrases are now
somewhat similar to current law by authorizing access “If the
law and to facilitate efforts to find the source of problems
absent. For example, the bill broadens the ability to access
Secretary has a reasonable belief that an article of food and any
(including during product recal s) when they do occur. One of
records by deleting the following conditional phrase in the
other article of food that the Secretary reasonably believes is
their concerns has been that records are not required to be
current law: “If the Secretary has a reasonable belief that an
likely to be affected in a similar manner is adulterated and
maintained in electronic format, which if required, these
article of food is adulterated and presents a threat of serious
presents a threat of serious adverse health consequences or
advocates assert, would greatly speed outbreak response.
adverse health consequences or death to humans or animals...”
death to humans or animals...” The second standard authorizes
Related issues include the types of records to be kept, how
(Drafters of the bill view this as new authority to access records access “If the Secretary believes that there is a reasonable
detailed they should be, how long they should be kept, and
during routine inspections.) The bill also no longer requires that
probability that the use of or exposure to an article of food, and
access and use of these records by authorities. For example, are
“written notice” be provided in advance of accessing records.
any other article of food that the Secretary reasonably believes
the current legal premises for accessing records (see below),
However, records not required to be immediately available at
is likely to be affected in a similar manner, will cause serious
adequate? Proposals for increased recordkeeping requirements
the start of a records inspection must be immediately available if
adverse health consequences or death to humans or animals...”
often raise questions about the intrusiveness of government,
requested in advance by letter. Also, relevant records (i.e., for
It appears that by invoking the second standard, the Secretary
privacy concerns, and the protection of sensitive commercial
access and copying) are to be all those “relating to such article
would no longer be required to have a reasonable belief that a
information (trade secrets), for example.
bearing on whether the food is adulterated, misbranded, or
food is adulterated in order to have access to records.
otherwise in violation of this Act...” rather than the higher
FFDCA § 414 currently authorizes the Secretary, by regulation,
current threshold—which is those records “needed to assist the Also apparently new under both standards would be the ability
to require that food establishments (except farms and
Secretary in determining whether a food is adulterated and
to access records if “any other article of food” could be similarly
restaurants) maintain certain records regarding foods, including
presents a threat of serious adverse health consequences.”
affected, such as food produced on the same manufacturing line
immediate previous sources, and immediate subsequent
as an implicated food, or food produced using implicated
recipients. “If the Secretary has a reasonable belief that an article New provisions spell out the conditions under which the
ingredients. Under either trigger, a designee of the Secretary is
of food is adulterated and presents a threat of serious adverse
Secretary could require remote access to records (i.e., not
to be granted access to records upon presentation of
health consequences or death to humans or animals,” such
appear at a facility to review them), notably where “...the
appropriate credentials and a written notice to such person, at
records must be made available for inspection and copying upon
Secretary has reasonable belief that an article of food presents a
reasonable times and within reasonable limits and in a
written notice. (Emphasis added.) The Secretary is required to
threat of serious adverse health consequences or death to
reasonable manner. Requirements apply to all records relating
take appropriate measures to ensure that unauthorized
humans or animals.”
to the manufacture, processing, packing, distribution, receipt,
disclosure of any trade secret or confidential information is
holding, or importation of a food, in any format (including paper
prevented.
Restaurants would be subject to some records access
and electronic formats), and at any location. No specific format
requirements. However, the only distribution of records which
is required. Farms and restaurants would continue to be
Obama Administration: The FSWG stated that the
may be required of restaurants under this subjection are those
excluded under FFDCA § 414.
Administration would work with Congress on “critical
showing the restaurant’s suppliers and subsequent distribution
legislation that will provide key tools .... to keep food safe.” One
other than to consumers.
CRS-46
Food Safety in the 111th Congress: H.R. 2749 and S. 510
Background, Applicable Current Law, and
Administration Statements
H.R. 2749 (House-passed)
S. 510 (Manager’s Amendment)
tool it cited was “the ability to access basic food safety records
Also, states that access to records provisions do not apply to
at facilities.” The Hamburg and Taylor testimonies express
farms—except that a farm owner, operator, or agent must
support for § 106 of the House bill.
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.)
Registration for Customs Brokers (§ 205)
A provision in this section requires every person importing or
brokering for import 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.”
Preventive Control Plans
Hazard Analysis, Risk-Based Preventive Controls, Food
Hazard Analysis and Risk-Based Preventive Controls (§
Safety Plan, Finished Product Test Results from
103)
A broad consensus of policymakers agrees that FDA’s system of
Category 1 Facilities (§ 102)
safeguards, which is based on a law first written early the last
Establishes a new FFDCA § 418, requiring the owner, operator,
century, is primarily reactive. By and large, the agency's statute
Also establishes a new FFDCA § 418, with provisions broadly
or agent in charge of a facility to develop a written plan and
and regulations spell out the reasons a food article is to be
similar to those in S. 510, but differing somewhat in detail and
carry out certain preventive activities in the plan, including:
considered adulterated or misbranded and therefore unfit for
organization. Like S. 510, requires the owner, operator, or agent
consumption. In effect, industry players are expected to abide by of a facility to analyze hazards and implement controls to
•
conducting an analysis to identify and evaluate known or
the rules; generally it is only when a problem is detected—often
prevent or reduce them, but unlike S. 510, requires a food safety reasonably foreseeable hazards that may be associated with the
after an illness outbreak is reported or testing finds a
plan to be developed and implemented before a facility
facility, hazards that may be intentionally introduced, including by
CRS-47
Food Safety in the 111th Congress: H.R. 2749 and S. 510
Background, Applicable Current Law, and
Administration Statements
H.R. 2749 (House-passed)
S. 510 (Manager’s Amendment)
contaminant in a product—that officials step in to correct it, or
introduces or delivers for introduction into interstate
acts of terrorism; and preparing a written analysis;
order the industry to do. So virtually all stakeholders, including
commerce any shipment of food.
regulators, the regulated industries, consumer advocates, and
•
identifying and implementing preventive controls, including
food safety scientists now agree that the foundations of any new
Requires (under § 418A) that this plan include a hazard analysis
at critical control points, if any, to provide assurances that
program should be an understanding of what, and how, hazards
to identify whether there are hazards, including those due to the identified hazards will be prevented or minimized, and that food
can enter the food supply, fol owed by implementation of
source of ingredients, that are reasonably likely to occur in the
is not adulterated or misbranded;
measures to prevent these hazards.
absence of preventive controls. The plan also must include
descriptions of:
•
developing a means to verify the effectiveness of these
FDA currently requires that managers of certain food facilities—
preventive controls;
those producing or processing seafood, some juices, and low-
•
preventive controls being implemented including those to
•
implementing corrective actions if controls are found,
acid canned foods—prepare Hazard Analysis and Critical
address hazards identified by the Secretary;
through monitoring, not to have been effective (specifies that
Control Point (HACCP) plans for their operations. HACCP is a
•
procedures for monitoring preventive controls;
corrective actions ensure “(1) appropriate action is taken to
preventive approach that incorporates hazard analysis,
reduce the likelihood of recurrence of the implementation
appropriate process controls, verification, and other steps
•
procedures for taking corrective actions;
failure; (2) all affected food is evaluated for safety; and (3) all
throughout the production process. A cornerstone of HACCP
•
verification activities including validation that such controls
affected food is prevented from entering into commerce if the
is the identification of hazards by industry that are “reasonably
are effective (to include use of environmental and product
owner, operator or agent in charge of such facility cannot
likely to occur.” The emphasis on hazards that are reasonably
testing programs);
ensure that the affected food is not adulterated,” as defined by
likely to occur assures that such hazards—such as microbial
law)
contamination in fresh juices, or botulism in low-acid canned
•
monitoring of such preventive controls to verify
foods—are systematical y and consistently addressed.
effectiveness;
•
verifying that preventive controls are effective, that
monitoring is ongoing, that corrective actions are taken when
There is no explicit statutory authority or requirement
•
record keeping procedures (records must be kept for at
needed, and that the plan is periodically reviewed for continued
regarding HACCP systems for FDA-regulated foods. FDA
least two years);
relevance;
regulations requiring HACCP plans and systems for seafood,
•
both established recall procedures and traceback
fruit and vegetable juices, and low-acid canned foods cite the
•
keeping and maintaining, for at least two years, records
procedures;
applicable statutory authority as FFDCA § 402(a), which defines
documenting the monitoring of preventive controls, relevant
adulteration, and the Secretary’s general authority to
•
procedures to ensure the safety of the supply chain for
instances of nonconformance, instances when corrective actions
promulgate regulations to assure the safety of foods, at FFDCA
ingredients;
were implemented, and the efficacy of preventive controls and
§ 701(a).
corrective actions.
•
procedures to implement performance standards issued by
At the U.S. Department of Agriculture, the Food Safety and
the Secretary (under a new FFDCA § 419).
Applicable definitions are provided in this section for “critical
Inspection Service (FSIS) in 1996 began implementing rules to
control point,” “facility,” and “preventive controls.” The
establish a mandatory HACCP for meat and poultry, using its
The owner, operator, or agent must conduct a reanalysis of
required plan and associated documentation of performance
authority to regulate major meat and poultry species under the
hazards (and revise preventive controls if necessary): (1) at least
must be made promptly available to an authorized
Federal Meat Inspection Act (FMIA) and Poultry Products
every two years (S. 510 is every three years); (2) if there is a
representative of the Secretary upon oral or written request.
Inspection Act (PPIA). Record keeping and verification are used
change in the process or product that could affect the hazard
The hazards must be reanalyzed at least every three years, or
to ensure that the system is working. Following a phase-in
analysis; and (3) if the Secretary determines it is appropriate to
sooner if there is a change in processes or practices that could
period to accommodate smaller sized establishments, and since
protect public health. Limits the Secretary’s ability to delegate
create or worsen a hazard. The Secretary may require a revision
January 2000, al slaughter and processing operations have been
the authority to order revisions. Contains applicable definitions
of the plan based on a new hazard or new scientific information,
required to have HACCP plans in place. HACCP is intended to
(including one not in S. 510 defining “hazard that is reasonably
including, as appropriate, “results from the Department of
operate as an adjunct to the traditional methods of facility
likely to occur”), the same deemed compliance for seafood,
Homeland Security biological, chemical, radiological, or other
inspection, which still are mandatory under the original statutes.
juice, and low-acid canning facilities, and the same effective dates terrorism risk assessment.” Failure to comply with the
based on business size as in S. 510.
requirements of this section is prohibited under FFDCA § 301.
CRS-48
Food Safety in the 111th Congress: H.R. 2749 and S. 510
Background, Applicable Current Law, and
Administration Statements
H.R. 2749 (House-passed)
S. 510 (Manager’s Amendment)
Obama Administration: The FSWG stated that the
Also as is similar in S. 510, the Secretary is required to issue
Seafood, juice, and low-acid canned-food facilities that are
Administration would work with Congress on “critical
guidance or regulations on standards for conducting a hazard
already in compliance with applicable FDA regulations are
legislation that will provide key tools .... to keep food safe.” One
analysis and establishing preventive controls. However, the
deemed to be in compliance with this section. Facilities subject
tool it cited was the ability to require sanitation and preventive
Secretary must allow the facility to implement an alternative
to requirements in FFDCA § 419, as established by this act
controls at food facilities, based on a scientific hazard analysis.
preventive control if it is able to demonstrate that it effectively
(regarding safety standards for produce), are not subject to this
The Hamburg and Taylor testimonies express support for § 102
addresses the hazard. Food from facilities not in compliance with section. The Secretary may, by regulation, exempt or modify the
of the House bill.
these provisions are to be considered adulterated under the
requirements of this section for facilities that are solely engaged
FFDCA.
in the production of food for animals other than man, the
storage of raw agricultural commodities (other than fruits and
In issuing guidance or regulations, the Secretary must, to seek
vegetables) intended for further distribution or processing, or
consistency, review relevant international standards for hazard
the storage of packaged foods that are not exposed to the
analysis and preventive controls. The Secretary also must
environment. This section does not limit the Secretary’s
consider their impact on small businesses and must issue
authority to revise, issue or enforce regulations for specific
guidance to assist small businesses in complying.
types of foods, such as the HACCP regulations currently in
The Secretary is authorized to exempt from or modify, by
effect for certain foods. This section does not apply to dietary
regulation, the requirements with respect to facilities engaged
supplements.
solely in the production of food for nonhumans (and may take
Considering existing regulatory hazard analysis and preventive
into account differences between human and animal foods),
control programs to determine applicable internationally
facilities that store packaged foods not exposed to the
recognized standards, the Secretary shall promulgate regulations
environment, or facilities that store raw agricultural
not later than 18 months after enactment regarding the
commodities for further distribution or processing.
implementation of requirements under this section, and shall
Further, under a new FFDCA § 418B, the Secretary must
issue an applicable guidance document. Regulations shall be
require submission of finished product test results by the owner, sufficiently flexible to be applicable in all situations, including the
operator, or agent of each category 1 facility (see “Risk-Based
operations of small businesses. This section does not provide
Inspection Schedule,” below, for definition of such facility)
the Secretary with the authority to apply specific technologies,
“...documenting the presence of contaminants in food in the
practices, or critical controls to an individual facility.
possession or control of such facility posing a risk of severe
Contains clarifying language regarding the promulgation of FDA
adverse health consequences or death.” Such submissions are
regulations, including consideration for various types of
those determined by the Secretary to be feasible and
businesses and activities (on-farm and at processing facilities).
appropriate and taking into consideration available information
Contains provisions for consideration of smal businesses.
on potential risks; and this section is not to: construe a
Requires the Secretary to issue a ”small entity compliance policy
requirement for mandated “testing or submission of test results
guide” setting forth the requirements of such regulations to
that the Secretary determines would not provide useful
assist smal entities in complying with the registration
information in assessing the potential risk presented by a facility
requirements and other activities (no later than 180 days after
or product category”; or to limit the Secretary’s authority under the issuance of the regulations under this section), along with
other provisions to access information or test results including
other flexibility and extended implementation deadlines for small
in the course of an investigation of an illness or contamination
and very small businesses. Requirements become effective in
incident.
stages according to the size of the business: businesses must be
This requirement is to take effect on the sooner of either 2
compliant 18 months after the date of enactment, except smal
years from date of enactment or the completion of a feasibility
businesses (as defined by the Secretary) are to have 2 years after
CRS-49
Food Safety in the 111th Congress: H.R. 2749 and S. 510
Background, Applicable Current Law, and
Administration Statements
H.R. 2749 (House-passed)
S. 510 (Manager’s Amendment)
study and at least two pilot projects that are required. Food
enactment, and very smal businesses (as defined by the
from a facility not in compliance with the requirements of new §
Secretary) 3 years after enactment.
418B is adulterated.
Seafood
No comparable provisions.
Requirements for Guidance Relating to Post Harvest
Processing of Raw Oysters (§ 114)
The National Shel fish Sanitation Program (NSSP) is the
federal/state cooperative program recognized by FDA and the
Creates for the Secretary and GAO certain requirements (see
Interstate Shel fish Sanitation Conference (ISSC; see next
below) triggered when the FDA issues—related to the post
paragraph) for the sanitary control of shel fish produced and
harvest processing of raw oysters—(1) guidance, regulation, or
sold for human consumption. The purpose of the NSSP is to
suggested amendment to the NSSP’s Model Ordinance; or (2)
promote and improve the sanitation of shel fish (oysters, clams,
guidance or regulation relating to the Seafood HACCP Program
mussels and scal ops) moving in interstate commerce through
(21 CFR parts 123 and 1240).
federal/state cooperation and uniformity of state shellfish
programs. Participants in the NSSP include agencies from
Not later than 90 days prior to issuance, requires the Secretary
shel fish producing and non-producing States, FDA, EPA, NOAA,
to submit to Congress a report on the projected public health
and the shellfish industry.
benefits, cost of compliance, feasibility of implementation, and
certain other topics. This requirement does not apply to the
The ISSC is a voluntary national organization of state shellfish
guidance described in 103(h) (Updating Guidance Relating to
regulatory officials that provide guidance and counsel on matters
Fish and Fisheries Products Hazards and Controls, discussed
for the sanitary control of shel fish. The ISSC has adopted formal
below). This requirement is waived if the Secretary issues a
procedures for state representatives to review shellfish
guidance that is adopted as a consensus agreement between
sanitation issues and develop regulatory guidelines. Following
federal and state regulators and the oyster industry, acting
FDA concurrence, these guidelines are published in revisions of
through the ISSC.
the NSSP Model Ordinance.
Not later than 30 days after the Secretary issues a proposed
FDA’s Seafood HACCP Program regulations are articulated in
regulation or guidance described above, requires the GAO to
21 CFR parts 123 (fish and fishery products) and 1240 (control
(1) review and evaluate the Secretary’s report and report its
of communicable diseases).
findings to Congress, (2) compare such proposed regulation or
guidance to similar regulations or guidance for other regulated
FDA’s Fish and Fisheries Products Hazards and Controls
foods, including a comparison of risk, and (3) evaluate the impact
Guidance was published by the agency to assist processors of
of post harvest processing on the competitiveness of the U.S.
fish and fishery products in the development of HACCP plans,
oyster industry domestically and in international markets.
which are required under regulations at 21 CFR 12. Despite
FDA’s stated intention to update the guidance every 2 to 3
Requires any report prepared under the section to be made
years, the most recent edition is dated June 2001.
public.
Updating Guidance Relating to Fish and Fisheries Products
Hazards and Controls (part of §103) 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.
CRS-50
Food Safety in the 111th Congress: H.R. 2749 and S. 510
Background, Applicable Current Law, and
Administration Statements
H.R. 2749 (House-passed)
S. 510 (Manager’s Amendment)
Performance Standards
Performance Standards (§ 103)
Performance Standards (§ 104)
Performance standards are typically specific, quantitative
Similar in intent but not identical to S. 510. Under a new FFDCA In coordination with USDA, the Secretary shall, at least every
measurements of a property of, or a substance in, food. They
§ 419, the Secretary must at least every two years review and
two years, review and evaluate relevant health data and other
may apply strictly to the property being measured, or serve as
evaluate epidemiological data and other appropriate information, relevant information, including epidemiological and toxicological
benchmarks for whether the food is safe in a broader sense. For
including research under § 123 (the research section) of the bill,
data and other appropriate information to determine the most
example, a performance standard for a single microbe might be
to identify the most significant food-borne contaminants and
significant foodborne contaminants.
used to determine whether a product is contaminated with
resulting hazards. Following each review, the Secretary must
microbes in general. (This approach is sometimes cal ed process
publish in the Federal Register a list of contaminants that have
Based on such review and evaluation and when appropriate to
verification.) Such a finding could indicate a problem with the
the greatest adverse impact on public health (and must consider
reduce the risk of serious illness or death to humans or animals,
product’s processing, and prompt a review of processing
the number and severity of illnesses and deaths associated with
or to prevent the adulteration of the food under FFDCA § 402
activities. The FFDCA (in various provisions in Chapter IV,
the contaminant in a food).
or the spread of communicable disease under PHS Act § 361,
regarding food) authorizes FDA to promulgate standards for
the Secretary shall issue contaminant-specific and science-based
certain hazards, such as maximum permissible levels (cal ed
The Secretary must issue, “as soon as practicable” through
guidance documents, actions levels, or regulations. Such
tolerances) for residues of pesticides or drugs in foods. The
guidance or by regulation, science-based performance standards
standards shal apply to products and product classes, may
FFDCA does not grant FDA the explicit authority to develop
(which may include action levels) to significantly minimize,
differentiate between food for humans and food for animals, and
standards solely as a means to verify that processing is carried
prevent, or eliminate such hazards. The standards shall apply to
shall not be written to be facility-specific. HHS shall coordinate
out in a manner that assures the safety of the food.
foods and food classes. Foods not meeting required standards
with USDA to avoid duplication of effort regarding guidance
are to be considered adulterated. The Secretary is authorized to documents for the same contaminant. The Secretary will issue
Obama Administration: The FSWG stated that the
make recommendations to industry on product sampling. Finally, and periodically review/revise all guidance documents and
Administration would work with Congress on “critical
the Secretary must report to Congress on the review including
regulation.
legislation that will provide key tools .... to keep food safe.” One
how the Secretary will address significant hazards and any
tool it cited was the ability to establish performance standards
resource or data limitations that preclude further action.
to measure the implementation of proper food safety standards.
The Hamburg and Taylor testimonies express support for § 103
of the House bill.
Produce and On-Farm Food Safety
Safety Standards for Produce and Certain Other Raw
Standards for Produce Safety (§ 105)
Agricultural Commodities (§ 104)
As noted earlier, the FFDCA authorizes FDA to promulgate
Subsection (a) of this section establishes a new FFDCA § 419,
standards for certain hazards, some of which, such as maximum
Under a new FFDCA § 419A, within 18 months of enactment,
regarding safety standards for produce. Within one year of
permissible levels (called tolerances) for residues of pesticides,
the Secretary (in coordination with the Secretary of Agriculture) enactment, the Secretary (in consultation with USDA and state
may apply to produce. The FFDCA does not grant FDA explicit
must publish a notice of proposed rulemaking, and within three
agriculture departments, including with regard to the national
authority to develop standards solely as a means to verify that
years after such date, final rules establishing scientific and risk-
organic foods program, and in consultation with DHS), is
processing is carried out in a manner that assures the safety of
based standards for the safe growing, harvesting, processing,
required to publish a notice of proposed rulemaking for science-
the food. FDA has several voluntary efforts in place to address
packing, sorting, transporting, and holding of those types of raw
based minimum standards for the safe production and harvesting
safety in the produce industry. For example, in February 2008,
agricultural commodities that are from a fruit, vegetable, nut, or
of those fruits and vegetables that are raw agricultural
the agency issued the final version of the Guide to Minimize
fungus, and for which the Secretary has determined such
commodities (including mixes and specific categories of fruits
Microbial Food Safety Hazards of Fresh-cut Fruits and
standards are reasonably necessary to minimize the risk of
and vegetables), for which the Secretary has determined that
Vegetables, which contains non-binding recommendations
serious adverse health consequences or death to humans or
such standards minimize the risk of serious adverse health
regarding: primary production and harvesting of fresh fruits and
animals
consequences or death. The Secretary may exclude from such
vegetables; personnel; buildings and equipment; sanitation
rulemaking commodities determined to be low risk when
operations; production and process controls; documentation
These regulations may set forth procedures and practices that
produced or harvested by smal or very smal businesses. The
CRS-51
Food Safety in the 111th Congress: H.R. 2749 and S. 510
Background, Applicable Current Law, and
Administration Statements
H.R. 2749 (House-passed)
S. 510 (Manager’s Amendment)
and records; traceback; and recall. On September 2, 2008, FDA
the Secretary determines reasonable to prevent known or
Secretary shal hold at least 3 public meetings on such
published a notice in the Federal Register seeking comments and reasonably foreseeable biological, chemical, and physical hazards, rulemaking in diverse geographic areas.
data to assist the agency in its revision, now underway, of its
including natural ones, that may be intentionally or
1998 Guide to Minimize Microbial Food Safety Hazards for
unintentionally introduced. The regulations may include
Proposed rulemaking shall “provide sufficient flexibility to be
Fresh Fruits and Vegetables. Also, FDA asserts that it has been
minimum safety standards, and address manure use, water
applicable to various types of entities…including smal businesses
engaged in efforts to identify hazards commonly associated with
quality, employee hygiene, sanitation and animal control, and
and entities that sel directly to consumers, and be appropriate
fresh produce, and to develop tracking and tracing methods.
temperature controls, as the Secretary determines to be
to the scale and diversity” of production and harvesting. The
reasonably necessary. They may provide for coordination of
proposed rule also shal address minimum standards for other
Under the Agricultural Marketing Agreement Act of 1937 (7
education and enforcement activities and must provide a
specified elements, including soil amendments, hygiene,
U.S.C. § 601 et seq.), producers and handlers can organize
reasonable time for compliance, taking into account the needs of packaging, temperature controls, animal encroachment and
themselves under legally binding marketing orders that can
smal businesses for additional time, among other permitted
water, as well as hazards that occur naturally or that may have
include quality (and possibly, safety) standards. The act is
activities. The Secretary is required to take into consideration
been introduced, intentionally or unintentionally. The proposal
overseen by USDA’s Agricultural Marketing Service (AMS). In an (consistent with public health) “the impact on small-scale and
shall take into consideration, consistent with public health
advance notice of proposed rulemaking, AMS in October 2007
diversified farms, and on wildlife habitat, conservation practices,
protection, “conservation and environmental practice standards
invited comments on whether to create such a federal
watershed-protection efforts, and organic production methods.” and policies established by Federal natural resource
marketing program that specifical y would require handlers
The Secretary shal coordinate with the Secretary of Agriculture
conservation, wildlife conservation, and environmental
(packers, processors, shippers) of leafy greens, including lettuce
and may contract and coordinate with a Governor-designated
agencies,” and also “in the case of production that is certified
and spinach, to meet prescribed safety standards. A similar state state agency for education and compliance activities (emphasis
organic, not include any requirements that conflict with or
order was adopted by California growers in 2006. Further
added to distinguish from S. 510, which mandates use of state
duplicate the requirements of” the national organic foods
action on a federal order had not occurred as of early August
agencies).
program, while providing the same level of protection as
2009.
required under this act. Priority is to be given to those raw
Under this new provision, a food is adulterated if it is grown,
fruits and vegetables that have been associated with food-borne
Obama Administration: The FSWG announced, and FDA
harvested, packed, sorted, transported or held under conditions
illness outbreaks.
issued on July 31, 2009, new draft guidances on three specific
that do not meet these new requirements. The bill appears to
types of produce: Guide to Minimize Microbial Food Safety
lack the variance procedures, and the express exemption for
Subsection (b) states that within a year of the closing of the
Hazards of Tomatoes, Guide to Minimize Microbial Food Safety
those required to meet hazard analysis and prevention standards comment period, the Secretary shall adopt a final rule to
Hazards of Melons, and Guide to Minimize Microbial Food Safety that are in S. 510.
provide for minimum standards for certain types of fruits and
Hazards of Leafy Greens, which, when finalized (and as is the
vegetables, as needed to minimize the risk of serious adverse
case for all FDA guidance documents), will be nonbinding and
Requires the Secretary to update the 1998 guidance for
health consequences. Among other requirements, the final rule
will represent FDA’s current thinking on these topics.
minimizing hazards in fresh fruits and vegetables.
shall provide for coordination of education and enforcement
Comments on the documents are to be accepted until October
activities with state and local officials, minimize recordkeeping
2, 2009 (see 74 FR 38437-40).
burdens, and describe the variance process and the types of
permissible variances that the Secretary may grant to states and
Also, the Hamburg and Taylor testimonies express support for §
foreign countries to address local growing conditions. Effective
104 of the House bill.
dates for compliance are phased in for small and very small
business (see below). The Secretary may coordinate with USDA
and shall 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, after consultation with
stakeholders (as specified). This section shall not apply to
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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 HACCP programs already in place.
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: small
businesses (as defined by the Secretary) are to have 1 year after
final regulation are promulgated, and very small 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 smal
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
smal 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.
Targeting of Inspection Resources
Risk-Based Inspection Schedule (§ 105)
Targeting of Inspection Resources for Domestic
Facilities, Foreign Facilities, and Ports of Entry; Annual
Reform advocates argue that many of the recent problems that
Amends § 704 (Inspection, in the General Authority chapter of
Report (§ 201)
have led to illness outbreaks and recalls might have been
the FFDCA) to require each § 415-registered facility to be
avoided if inspectors were more frequently present in plants to
inspected randomly by officers duly designated by the Secretary
Subsection (a) of this section establishes a new FFDCA § 421 (in
monitor sanitary conditions and processes. Due to the differing
at a frequency based on the risk of the facility. The Secretary
the food chapter of the FFDCA), requiring the Secretary, with
laws and circumstances that apply to FSIS, for example, that
may use federal, state, or local officials for domestic inspections
respect to facilities that must register under FFDCA § 415, to
agency's inspectors are in meat and poultry slaughter and
and foreign country representatives for foreign ones. The
al ocate inspection resources according to the “known safety
processing plants every day, where they must organoleptically
inspection schedule must be implemented within 18 months of
risks” of the food and countries involved, as well as the facility’s
(by the senses) examine every live animal and every carcass for
enactment and follow these prescribed categories and
compliance history, the rigor of its hazard analysis and risk-
defects, and must pass every item before it can enter commerce. frequencies:
based preventive controls, among other stated criteria.
Establishes separate inspection frequencies and increasing
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S. 510 (Manager’s Amendment)
Current law, which derives from FFDCA § 704 (in the General
•
Category 1, a high-risk food facility that manufactures or
frequency rates for domestic and foreign facilities for both high-
Authority chapter of the FFDCA), authorizes but does not
processes food, must be inspected at least every 6-12 months;
risk and non-high-risk entities. Establishes requirements for
require FDA to inspect food facilities. Therefore, no periodic
identification and inspection at ports for imported foods,
inspection frequency is currently required.
•
Category 2, a low-risk facility that manufactures or
including consideration of whether the shipment has been
processes food or a facility that packs or labels food, must be
certified under a voluntary qualified importer program or other
Obama Administration: The FSWG stated that the
inspected at least every 18 months to 3 years;
criteria.
Administration would work with Congress on “critical
legislation that will provide key tools .... to keep food safe.” One
•
Category 3, a food facility that holds food, must be
The Secretary shall improve coordination and cooperation with
tool it cited was “the ability to use resources flexibly to target
inspected at least every 5 years.
the Secretaries of Agriculture and Homeland Security to target
food at the highest risk and achieve the maximum gain for public Authorizes the Secretary to modify the types of food facilities
food inspection resources. It also authorizes interagency
health.” However, Dr. Hamburg’s testimony noted several issues within each category, to alter inspection frequencies if needed to agreements regarding seafood (involving HHS, DHS, Commerce
regarding § 105 of the House bill (as introduced prior to
respond to illness outbreaks and recalls, and to inspect a facility
Department, and the Federal Trade Commission, among other
subcommittee markup), including both the large amount of
more frequently than specified. In doing so, the Secretary is to
agencies); such agreements may include examining and testing
resources needed to meet the inspection goals in the bill and
consider the type of food at the facility, its compliance history,
seafood imports, coordinating inspections of foreign facilities,
the difficulty of hiring and training the additional staff that would
whether an importing facility is certified (under the new
standardizing data, among others. Provides for advisory
be needed. She recommended modification “to take into
certification requirements the bill would set; see below), and
committee consultation within HHS with respect to al ocating
account the operational chal enges involved, such as by changing
other factors determined relevant by the Secretary. The
inspection resources.
these inspection frequencies .... flexibility to modify the
Secretary is authorized to publish in the Federal Register
Subsection (b) of this section requires the Secretary to report
inspection requirements based on the best available data on
adjustments to inspection frequencies in category 2 and 3
to Congress, by February 1 of each year, providing specified
risk,” among other things. In his subsequent testimony on the
facilities, and is required to publish in the Federal Register any
information regarding: domestic and foreign food facility
House committee-approved bill, Mr. Taylor expressed support
proposed modifications of the categorization of any facility or
inspections (including those scheduled but not completed); food
for its flexibility to adjust inspection frequencies.
facility type. The Secretary must submit an annual report on the
imports; and FDA foreign offices. Such reports shall be made
inspections to Congress, which is to include numbers inspected
publicly available.
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.
Laboratory Accreditation
Testing by Accredited Laboratories (§ 110)
Recognition of Laboratory Accreditation for Analyses of
Foods (§ 202)
Neither the FFDCA nor applicable regulations address the
Establishes a new FFDCA § 714, which requires the Secretary to
accreditation of food laboratories or the establishment of
establish a standards-based program for the recognition of
Subsection (a) establishes a new FFDCA § 422, requiring the
laboratory networks.
laboratory accreditation bodies that accredit laboratories to
Secretary, within two years of enactment, to establish a program
perform analytical testing for the purposes of this section. In
for food testing by accredited laboratories that meet certain
FDA continues to support an existing Food Emergency
evaluating whether such bodies meet the Secretary’s standards,
requirements established by the Secretary; to establish a publicly
Response Network (FERN), a nationwide network made up of
the Secretary is authorized to observe these bodies’ on-site
available (subject to national security concerns) registry of
more than 130 federal, state and local public health laboratories
audits of laboratories, and to conduct an on-site audits under
accrediting bodies recognized by the Secretary and accredited
that support emergency response activities related to food
specified conditions. The Secretary is required to publish on the
laboratories (such accredited entities would be required to
defense and food safety. The FDA Office of Regulatory Affairs
FDA website a list of accreditation bodies.
report any changes to the Secretary). Foreign labs would need
publishes a Laboratory Manual with a section on “Private
to meet the same accreditation standards as domestic labs. The
Laboratory Guidance.” The Guidance seeks to “establish a
Any analytical testing must be done by a laboratory that is
Secretary shall develop model accreditation standards that
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S. 510 (Manager’s Amendment)
uniform, systematic, and effective approach to ensuring that
accredited by an above-accredited body and that samples such
address sampling and analytic procedures, quality controls,
private labs performing analyses on FDA-regulated imported
articles with adequate controls to ensure the integrity of the
personnel training and qualifications, and other matters. The
commodities submit scientifically sound data.” The Guidance,
samples, except that testing pursuant to FFDCA §801(a)
Secretary shal review accreditation bodies at least once every
although unenforceable, provides recommendations on sampling
(relating to testimony on refused imports) must be by an
five years and promptly revoke recognition for an accrediting
techniques, requirements of lab analysts, reviewing the analyzed
independent laboratory. This section contains notification
body that is not in compliance with this section. Food testing
packages, and auditing analyzed samples.
requirements for accreditation bodies and for others (such as
shal be conducted by accredited labs no later than 30 months
the results of al analyses conducted), among other provisions.
after enactment, unless otherwise exempted.
In January 2009, FDA issued guidance regarding voluntary third-
Any violation of this section’s requirements is considered a
party certification programs for foods and feeds. The guidance
prohibited act under the FFDCA.
Food testing in the following situations shall be conducted by a
does not focus on laboratory accreditation, but rather the ways
federal laboratory or a laboratory accredited according to the
in which third-party certifiers should use laboratory results in
requirements of this section whenever such testing is: (1) by or
their assessments. The guidance, which also is not enforceable,
for an owner or consignee in response to a specific testing
says that laboratories should conform to existing international
requirement under the FFDCA or its regulations when applied
standards and guidelines.
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
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S. 510 (Manager’s Amendment)
tribal food laboratories, including data sharing to develop
national situational awareness; (3) provides accessible, timely,
accurate, and consistent food laboratory services 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.
Other Laboratory Provisions
Plan and Review of Continued Operation of Field
Integrated Consortium of Laboratory Networks (§ 203)
Laboratories (§ 209)
Several national networks of laboratories are currently in
The Secretary of Homeland Security, in consultation with the
operation. None is explicitly authorized in law. Existing
The House bill contains no provision comparable to the
Secretaries of HHS and USDA and the EPA Administrator, shall
networks include: the Laboratory Response Network (LRN),
integrated consortium provision in S. 510. § 209 does require
maintain an agreement whereby relevant laboratory network
run by CDC and federal and state partner groups to conduct
the Secretary to submit, to Congress and the Comptrol er
members: (1) agree on common laboratory methods to facilitate
public health testing during emergencies; the Food Emergency
General, a reorganization plan at least 90 days prior to
information sharing regarding animal health, agriculture, and
Response Network (FERN), coordinated by FDA; and the
terminating or consolidating any of the 13 field laboratories
human health; (2) identify the means by which each laboratory
National Animal Health Laboratory Network, coordinated by
responsible for analyzing food that are operated by FDA’s Office network member could work cooperatively to optimize national
USDA.
of Regulatory Affairs, or terminating or consolidating any of the
laboratory preparedness and provide surge capacity during
20 district offices with responsibility for food safety. This section emergencies; and (3) engage in ongoing dialogue and build
Obama Administration: Its FY2010 budget requested an
also subjects such a reorganization plan to the requirements of
relationships to support a more effective and integrated
increase in the number of chemical laboratories under FERN
the Congressional Review Act (5 U.S.C. §§ 801-808), which
response during emergencies. The Secretary of Homeland
through cooperative agreements, and to invest in FDA high-
establishes a special set of expedited or "fast track" legislative
Security shal publish and report biennial y to Congress on the
volume laboratories for better sample analyses and faster
procedures, primarily in the Senate, through which Congress
progress of this integrated consortium.
testing. The administration proposed retaining the FY2010 level
may enact joint resolutions disapproving agencies' final rules.
for FY2011.
Third-Party Accreditation
Certification and Accreditation (§ 109, part)
Accreditation of Third-Party Auditors (§ 307)
The use of so-called third parties is increasingly being promoted
Appears to be less detailed with regard to how the Secretary is
Amends FFDCA Chapter VIII (regarding imports and exports),
as a method for helping regulators such as the FDA to carry out
to establish a third-party certification program. As noted,
adding a new § 808, for a system of third-party auditors and
their oversight responsibilities, particularly when they are being
qualified certifying entities are to be accredited and given the
audit agents that are accredited to certify that entities involved
asked to stretch and careful y target finite inspection dol ars and
responsibility to provide such certifications when the Secretary
with imports are meeting applicable FDA requirements.
personnel. However, the idea is controversial, particularly
determines such certifications are needed, and the specifics of
Generally, the Secretary would first recognize accreditation
among food safety advocates, who have expressed concern
that certification, including its format, would be left to the
bodies. Such bodies in turn could accredit the third-party
about potential conflicts of interest between auditors and the
Secretary’s regulatory discretion. § 109 defines “qualified
auditors or audit agents, who in turn could be tasked to certify
companies they audit and about potentially less rigorous
certifying entity” as “an agency or a representative of the
eligible entities. Defines the following terms: audit agent,
oversight. They cite a number of recent food safety crises
government from which the article originated, as designated by
accreditation body, third-party auditor, accredited third-party
including the Salmonella contamination of peanut products in
such government or the Secretary; or an individual or entity
auditor, consultative audit, eligible entity, and regulatory audit.
late 2008 and early 2009, even though the peanut product
determined by the Secretary or an accredited body recognized
supplier had passed several private third-party and state
by the Secretary to be qualified to provide a certification...”
The Secretary must establish the new system within two years
inspections.
of enactment and is required to: promptly revoke recognition of
Requires the Secretary to issue regulations to ensure that
accreditation bodies found not in compliance with this section’s
Among many questions is the definition of a “third party.”
certifying entities and their auditors are free from conflicts of
requirements and develop model accreditation standards (within
Broadly, it may be any entity or person that is formal y assigned
interest (in doing so, the Secretary may rely on or incorporate
18 months after enactment), taking into account existing
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S. 510 (Manager’s Amendment)
one or more responsibilities that otherwise would be
international certification standards), Contains extensive
standards so as to avoid duplication of efforts and costs.
performed by another entity. In practice and in proposed
language on what these regulations are to stipulate, such as that
Accreditation bodies must submit to the Secretary a list of all
legislation, third parties might variously and specifically be
entities have written policies; that they obtain and maintain
accredited third-party auditors and audit agents they have
defined as a state or local agency, another federal agency, a
annual declarations of al personnel involved in audits regarding
accredited.
foreign government, a professional or scientific body, or even a
their financial interests in any producer, manufacturer, and other
private company, often one that specializes in the task to be
specified types of food companies; that they not be owned,
Accreditation bodies must, prior to accrediting a foreign
performed. Private companies frequently rely on third party
operated, control ed, or have any other financial ties to those or government or foreign government agency, perform reviews and
auditors, certifying agents and the like, often including provisions the products they are certifying. (However, the certifying entity
audits of that government or agency’s food safety programs,
in their contracts with suppliers, for example, that a third party
could provide consultative services to a facility it is certifying so
systems, and standards, as the Secretary deems necessary, to
verify that certain specifications—whether safety, quality,
long as the Secretary has approved its procedures ensuring the
determine that the foreign government is capable of ensuring
quantity, or other desired attributes—are being achieved.
separation of these two functions.)
that entities or foods it certifies will meet the requirements of
Within the federal government, examples include a variety of
the FFDCA. Prior to accrediting foreign cooperatives and other
voluntary third-party auditing programs. For example, “Process
The Secretary must require that, to the extent applicable, any
third parties, accreditation bodies must perform reviews and
Verification and Audit Based Programs,” operated by USDA's
certification provided by a certifying entity be renewed
audits as the Secretary deems necessary to determine that the
Agricultural Marketing Service (AMS) and are funded through
whenever the Secretary deems it appropriate; and he/she must
entities to be certified have systems in place to ensure the
user fees. These programs are intended primarily to certify food
refuse to accept any certification determined to be no longer
entities or foods will meet the requirements of the FFDCA.
quality and marketing attributes, as opposed to safety
valid or reliable. The Secretary must provide for the electronic
Accreditation bodies may not accredit a third party auditor
requirements per se.
submission of certifications, in coordination with Customs and
Border Protection.
unless it agrees to issue a written food or facility certification to
FDA appears to have argued in the past that its authority is
accompany each food shipment into the United States from an
broad enough, under the FFDCA and the PHS Act, at least to
Authorizes the Secretary, in evaluating an accreditation body, to
eligible entity. The Secretary must consider certifications of
propose regulations on how independent sampling services and
observe that body’s on-site audits of qualified certifying entities,
foods offered for import and participation in the voluntary
private laboratories can be used to satisfy food import
and to conduct on-site audits of certified facilities “upon request. qualified importer program when targeting inspection resources
requirements. However, FDA does not currently regulate
.... and upon presentation of appropriate credentials, at
and must use certification to determine whether food meets the
private laboratories that analyze imported, FDA regulated
reasonable times and within reasonable limits and in a
requirements for import and to determine whether facilities are
goods. (Under FFDCA § 704, FDA has been required to have
reasonable manner ....” to include access to records.
eligible for the voluntary qualified importer program established
published criteria for accrediting independent persons to
in § 302 of this act. Accredited third-party auditors can only
conduct inspections related to Class II and III devices.)
issue food and facility certifications after conducting certain
audits and activities. Only the Secretary and accredited third-
In January 2009, following a request for information and
party auditors can provide facility certifications. Only the
publication of a draft document, FDA issued guidance setting
Secretary, a Secretary-designated agency or representative of
criteria for others’ use of voluntary third-party certification
the country from which the food for import originated, or
programs for foods and animal feeds, noting that the federal
accredited third-party auditors can provide food certifications.
government “supports voluntary certification programs as one
way to help ensure products meet U.S. safety and security
Accredited third-party auditors or audit agents must prepare
standards and to allow federal agencies to target their resources
audit reports, which are to include a number of specified
more effectively.” FDA has also published a notice of a pilot
elements; provide, at the Secretary’s request, an onsite audit
program of voluntary third-party certification for imported
report or other reports or documents required for the audit
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 expresses
discovery during an audit of “a condition that could cause or
support for relying not only on foreign governments for
contribute to a serious risk to the public health” and the
international inspections but also having the flexibility to explore
identification of the eligible entity subject to the audit. Third-
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use of an accreditation system and audit the performance of
party auditors and audit agents must adhere to a series 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 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 affect the Secretary’s authority to inspect any eligible
entity.
Food Traceability
Traceability of Food (§ 107); Unique identification
Enhancing Tracking and Tracing of Food and
number for food facilities, importers, and custom
Recordkeeping (§ 204)
Traceability means the ability to follow the movement of a
brokers (§ 206)
product through its stages of production and distribution. As a
The Secretary, in coordination with USDA and state officials,
food safety tool, traceability helps government authorities and
Amends FFDCA § 414 to require the Secretary to establish by
shal improve the capacity of FDA to effectively and rapidly track
industry officials to locate the source of contamination
regulation a tracing system for food in, or to be imported into,
and trace foods in the event of an outbreak. Within 270 days of
(traceback) and to locate those who may have received the
the United States. These regulations are to enable the Secretary
enactment, the Secretary is required to establish pilot projects
contaminated food (trace forward). Records sufficient to identify “to identify each person who grows, produces, manufactures,
in coordination with the food industry to explore and evaluate
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products and to trace them quickly are considered to be
processes, packs, transports, holds, or sel s such food in as short methods to rapidly and effectively identify recipients of food to
important prerequisites for a successful recall. (see below.)
a timeframe as practicable but no longer than 2 business days.”
prevent or mitigate a foodborne illness outbreak and to address
Among other issues are the potential administrative and cost
The Secretary is authorized to include in such regulations the
credible threats of serious adverse health consequences or
burdens that a more extensive regulatory program might impose use of lot numbers, a standardized format for pedigree
death to humans or animals as a result of such food being
on those in the food system, as well as privacy concerns about
information, and the use of a common food nomenclature.
adulterated or misbranded.
records.
However, before promulgating regulations the Secretary is
Participants are to include one or more projects with the
§ 306 of the Public Health Security and Bioterrorism Response
required to first identify tracing technologies and methodologies
processed food sector and one or more projects coordinating
Act of 2002 amended the FFDCA to require any person who
that can enable each of the food industry sectors to: maintain
processors or distributors of fruits and vegetables that are “raw
manufactures, processes, packs, transports, receives, holds or
the ful pedigree of the food from source through subsequent
agricultural commodities,” reflecting the diversity of the food
imports foods into the United States to keep records that
distribution; make traceback interoperable with other systems;
supply and include at least three different types of foods that
enable the identification of the immediate previous supplier and
and use a unique identifier for each facility. Prior to proposing
have been the subject of significant outbreaks during the 5-year
the immediate subsequent recipient of the food (FFDCA § 414;
regulations, the Secretary also first must, to the extent
period preceding enactment, among other criteria for project
see also “Records Access and Records Inspection,” above).
practicable, assess costs, benefits and feasibility of adopting such
selection intended to inform future rule promulgation. The
technologies; conduct at least two public meetings; and conduct
Secretary shall report to Congress its findings for improving the
Obama Administration: The FSWG announced in July 2009
one or more pilots.
tracking and tracing of food within 18 months of enactment.
the following actions intended to improve traceability:
The traceback regulations will apply to agricultural producers
The Secretary, in coordination with USDA and state
•
within 3 months, FDA is to issue draft guidance on what
(and retailers), but the provision specifically exempts food that is departments of health and agriculture, shall collect additional
industry could do to establish product tracing systems;
produced on a farm or fishery (wild or farmed) and sold by that
data to assess product tracing technologies, among other
•
within 3 months, federal agencies are to implement a new
farm or fishery directly to a consumer, restaurant, or grocery
information. The Secretary, in consultation with USDA, shall
“incident command system to address outbreaks of foodborne
store. However, such farms and fisheries must keep records for
also establish within FDA a product tracing system to receive
illness;
at least 6 months documenting the restaurants or grocery stores information needed to track and trace food.
to which it sold; and the restaurants and grocery stores are
•
within 6-12 months, FSIS is to increase the capacity of its
required to keep records documenting the farm source. The
The Secretary shal publish a notice of proposed rulemaking to
public health epidemiology liaison program to State public health Secretary may also exempt a food or a type of facility, farm, or
establish additional recordkeeping requirements for high-risk
departments through new hires and expanded outreach;
restaurant from the regulations, or modify the requirements for
foods, subject to certain specified conditions (no later than two
years after enactment). The Secretary shall designate such high-
•
By July 2009, federal agencies were to ask State and local
these entities, if the Secretary “determines that a tracing system
risk foods within one year after enactment based on criteria
agencies to update their emergency operations procedures to
for such food ... is not necessary to protect the public health.”
specified in the provision, and shall publish the list of foods
be consistent with new food disease outbreak guidelines being
For this latter category of exemptions, each person who
designated as high-risk, which may be subject to updates and
issued by the Council to Improve Foodborne Outbreak
produces, manufactures, processes, packs, transports, or holds
revision. The provision addresses information protection;
Response;
such food still must maintain records that identify the immediate
previous sources of the food and its ingredients and the
requirements for public input; rules on retention of records; and
•
A promise that CDC is to work with collaborating States
immediate subsequent recipients.
less restrictive requirements (as specified) for: farm-to-school or
to evaluate and optimize best practices for more effective
farm-to-institution programs of USDA and other related
outbreak investigations, and within 12 months launch a new
Contains language limiting applicability to farms, including
programs; “identity-preserved labels” with respect to farm sales
system to facilitate information-sharing and adoption of best
requirements that the Secretary coordinate with the Secretary
of food that is produced and packaged on a farm; food that is
practices.
of Agriculture when conducting pilot projects with respect to
produced through the use of a fishing vessel; producers of
farms and when issuing regulations that will impact farms.
commingled raw agricultural commodities; grocery stores; direct
Also, the Hamburg and Taylor testimonies express support for § Furthermore, any new tracing system with respect to grain or
farm sales to consumers or grocery store; and others. The
107 of the House bill.
any “similarly handled commodities” (generally, those row crops Secretary may modify requirements, or exempt a food or facility
that have been covered by USDA price supports) must be
from them, if product tracing requirements are not needed to
“limited to enabling the Secretary to identify those who
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S. 510 (Manager’s Amendment)
received, processed, packed, transported, distributed, held, or
protect public health.
sold” such a commodity “from the initial warehouse operator
that held” it “for any period of time to the ultimate consumer.”
The Secretary shall submit a report to Congress “taking into
consideration the costs of compliance and other regulatory
burdens on smal 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 small 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.
Foodborne Illness Surveillance and Education
Surveillance (§ 121)
Surveillance (§ 205)
Surveillance for foodborne illness is carried out by the states,
This section generally mirrors the language in § 205 of the
For the purposes of this section, “foodborne illness outbreak” is
with assistance from the CDC. States also conduct investigations Senate bill, but lacks two of the provisions: the requirement for
defined as two or more cases of a similar illness resulting from
of foodborne illness outbreaks, in coordination with CDC,
a working group on foodborne illness surveillance; and the
the ingestion of a certain food. This section requires the
either FDA or FSIS (depending on implicated or suspected
reauthorization of the food safety capacity grants (see column at
Secretary, acting through the Director of the CDC, to enhance
foods), and, if appropriate, other federal agencies. FDA is
left).
foodborne illness surveillance systems by, among other things,
authorized to carry out such investigations, or to coordinate
enhancing system capacity; improving coordination and
with states in doing so: (1) under broad, permanent authorities
information sharing; incorporating research findings; making
in FFDCA § 702 regarding examinations and investigations, and § Public Education and Advisory System (§ 122)
surveillance data available to the public in appropriate formats;
909 regarding authority to assist states with examinations and
and integrating systems and data with other biosurveillance and
investigations; and (2) under several broad, permanent disease
This section of the bill requires the Secretary, in cooperation
related federal, state and local surveillance systems.
control authorities of the Secretary of HHS in Title III of the
with private, state and other public organizations, to design and
Appropriations are authorized for these activities at $24 million
PHS Act, which underpin CDC’s activities as well. These include
implement a national public education program on food safety.
annual y (FY2011-FY2015). The Secretary must also establish a
The section describes the elements to be included in the
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PHS Act § 301 regarding research and investigations, §§ 311 and
program, and further requires the Secretary to work with states
working group, comprised of public- and private-sector experts
317 regarding federal-state cooperation, and § 361 regarding
and others to develop and incorporate into the public education
and stakeholders, to meet and report at least annually, and make
control of communicable diseases. PHS Act § 317R provides an
program regional and national advisories concerning food safety.
recommendations for the improvement of foodborne illness
explicit but expired authority of the Secretary of HHS to award
surveillance systems.
grants to state and tribal governments to enhance food safety
surveillance and laboratory capacities. Although this authority
The Secretary shall, within one year of enactment, conduct an
has expired, the Secretary of HHS may carry out this activity
assessment of state and local food safety and defense capacities,
under the broad, permanent authorities mentioned earlier.
and shal subsequently develop and implement strategies to
enhance these capacities, in order to achieve a number of stated
A foodborne illness “outbreak” is not defined in law or
goals. This section also reauthorizes the food safety capacity
regulations that apply to either CDC or FDA. In common public
grants in PHS Act § 317R at $19.5 million for FY2010, and such
health practice, and as used by CDC, a “foodborne disease
sums as may be necessary for FY2011 through FY2015.
outbreak” is defined as “the occurrence of two or more cases of
a similar illness resulting from the ingestion of a common food.”
As a practical matter, particularly for less serious hazards,
foodborne disease outbreak investigations are not always
launched when only two people are affected. Botulism is an
exception. Because the disease is so often deadly, and usually
results from improperly canned products that consumers could
keep for years before eating, authorities typically launch an
investigation to identify and remove all potentially hazardous
products that may be linked to a single case of botulism.
Mandatory Recall Authority; Reportable Food Registry
Notification, Nondistribution, and Recall of Adulterated
Mandatory Recall Authority (§ 206)
or Misbranded Food (§ 111)
The Secretary does not have mandatory recal authority for
Subsection (a) of this section establishes a new FFDCA § 423
foods, except for infant formula under FFDCA § 412(f). A
This section establishes a new FFDCA § 420, effective not later
regarding recall of food. If the Secretary determines, based on
voluntary recal by a manufacturer or distributor may be
than one year after enactment, which requires certain persons
information gathered through the reportable food registry
undertaken at any time for other foods and al other FDA-
who place food in commerce to notify the Secretary of potential under FFDCA § 417 or through any other means, that there is a
regulated products. In urgent situations, FDA may request a
food safety problems; provides the Secretary with authority to
reasonable probability that an article of food (other than infant
voluntary recal of an FDA-regulated product [21 CFR 7.40(b)].
request a voluntary recal of food and to order that distribution
formula) is adulterated under FFDCA § 402, or misbranded
The Secretary has authority under FFDCA § 304 to seize foods,
of a food be ceased; and establishes authority of the Secretary
under FFDCA § 403(w) (specifical y regarding al ergen labeling),
drugs, and cosmetics that are adulterated or misbranded when
to mandate a recall, with procedures reflecting two different
and the use of or exposure to such article will cause serious
introduced into or while in interstate commerce, or while held
levels of threat that may be posed by an affected food.
adverse health consequences or death to humans or animals, the
for sale after shipment in interstate commerce.
Secretary shal provide the responsible party (as defined in
FFDCA § 420, subsection (a), requires a responsible party [as
FFDCA § 417) with an opportunity to cease distribution and
Also, the FDA Amendments Act of 2007 (FDAAA, P.L. 110-85)
defined in FFDCA § 417(a)(1)] or a person required to register
recal such article.
created FFDCA § 417, which required FDA to establish a
to import food under § 801(r) (as established by this act), to
reportable food registry to facilitate product identification and
notify the Secretary if there is reason to believe that an article of If a person fails to comply voluntarily with a request by the
tracing. Under FFDCA § 417, a “reportable food” is “an article
food when introduced into or while in interstate commerce, or
Secretary to cease distribution or sale of, or to recall, an article
of food (other than infant formula) for which there is a
while held for sale (regardless of whether the first sale) after
of food, the Secretary may order the person to cease
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reasonable probability that the use of, or exposure to, such
shipment in interstate commerce, is adulterated or misbranded
distribution and sale, and to immediately notify all persons
article of food will cause serious adverse health consequences
in a manner that presents a reasonable probability that the use
“manufacturing, processing, packing, transporting, distributing,
or death to humans or animals,” and registered food facilities
or consumption of, or exposure to, the article (or an ingredient
receiving, holding, or importing and selling such article;...and to
must notify the FDA electronically about such a reportable food. or component used in any such article) will cause a threat of
which such article has been distributed, transported or sold, to
Although FDA did not meet the deadline to implement the
serious adverse health consequences or death to humans or
immediately cease distribution of such article,” including
registry within 1 year of enactment of FDAAA, the agency
animals. (This language is similar to the reporting threshold
products distributed to a warehouse-based third party logistics
published compliance guidance for industry in September, 2009,
currently established under FFDCA § 417.) Failure to notify the
providers. The Secretary shall offer the responsible party an
and the reporting requirement became effective at that time.
Secretary when required is prohibited under FFDCA § 301.
opportunity for an informal hearing within two days of issuance
of such an order. If the Secretary subsequently determines that
Obama Administration: One of the actions announced by
FFDCA § 420, subsection (b), authorizes the Secretary to
the affected foods should not remain in commerce, the
the FSWG was to begin enhancing communication to the public,
request a voluntary recal by any person who distributes an
Secretary shall: amend the order to require a recall; specify a
including through an improved individual alert system allowing
article of food that the Secretary has reason to believe is
timetable for the recal ; require periodic reports from the
consumers to receive food safety information such as
adulterated, misbranded, or otherwise in violation of the
responsible party; and provide notice to consumers to whom
notification of recalls. The FSWG, and the Statement of
FFDCA.
the food was or may have been distributed. If, after the informal
Administration Policy on H.R. 2749, noted support for
hearing, the Secretary determines that adequate grounds do not
mandatory recal authority. The Hamburg and Taylor
FFDCA § 420, subsections (c) and (d), authorize the Secretary
exist for the order’s required actions, the Secretary shall vacate
testimonies express support for § 112 of the House bill.
to issue an order to cease distribution of any article of food that
the Secretary has reason to believe that the use or consumption or modify the order.
of, or exposure to, an article of food may cause serious adverse
Alcohol beverage are exempt from a mandatory recall or any
health consequences or death to humans or animals, with an
action pending initial action by the Alcohol and Tobacco Tax and
appeal process and other administrative matters specified
Trade Bureau.
(including limits on the Secretary’s authority to delegate
decisions regarding orders). Subsection (e) requires the
The Secretary shall work with state and local public health
Secretary to issue a mandatory recall order if the Secretary
officials in carrying out this section, as appropriate. In conducting
determines that problems have not been addressed through
a recall under this section, the Secretary shall issue a press
procedures under subsections (c) and (d). Certain requirements
release, and other notices as appropriate, to provide consumers
of such order are stipulated.
and retailers with information about the affected articles of food
and the risks posed; and shall consult USDA policies regarding
FFDCA § 420, subsection (f), authorizes the Secretary to
providing to the public a list of retail consignees receiving
proceed directly to a mandatory recal order if the Secretary has products involved in a Class I recall, and consider providing such
credible evidence or information that an article of food subject
a list to the public, if appropriate. If available, an image of the
to an order to cease distribution presents an imminent threat of
recalled article must be published on the FDA website. The
serious adverse health consequences or death to humans or
Secretary’s authority to issue or vacate recal orders shal not be
animals. In such case, the person must immediately recal the
delegated to anyone other than the FDA Commissioner and this
food while stipulated appeal procedures are carried out.
section shal not affect the authority of the Secretary to request
("Serious," which distinguishes the thresholds for the routine
or participate in a voluntary recall. The Secretary shall establish
(subsection (e)) and emergency (subsection (f)) mandatory recall an “incident command operation” within HHS no later than 24
authorities, is not defined.)
hours after the initiation of a mandatory recall that will adhere
The Secretary is required, as the Secretary deems necessary, to
to requirements for coordinated and timely communication.
notify consumers, and state and local health officials, of any
Not later than 90 days after enactment the Secretary shal
recall order issued under this section. Failure of a person to
include on the FDA website a consumer-friendly search engine
comply with any order issued by the Secretary under this
for locating information about recalled food.
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section is prohibited under FFDCA section 301. Any articles of
Under subsection (c) of this section, pursuant to FFDCA §
food intended for import and subject to a cease-distribution or
303(f)(2)(A), a person who does not comply with a recal order
recall order under this section shall be refused entry, under
under this section shal be subject to civil money penalties.
FFDCA section 801. Nothing in this section shal limit the
Under subsection (d) of this section, failure to comply with such
Secretary's authority to assure food safety through any other
an order is prohibited under FFDCA § 301.
provisions of the FFDCA, or the Public Health Service Act.
Reporting requirements:
Reportable Food Registry: Exchange of Information (§
112)
•
Requires GAO to submit a report to Congress (no later
than 90 days after enactment) that identifies and evaluates
The food registry reporting requirements under apply to
federal, state and local agencies with mandatory recall authority
facilities that are required to register under FFDCA § 415. This
of food, considers models for famer restitution in the case of
section of the House bill expands coverage to farms where food
erroneous recal s, and recommends how to minimize economic
is produced for sale or distribution in interstate commerce, to
costs.
restaurants and other retail food establishments, and to those
required by this bill to register as importers. The bill newly
•
Depending on the findings in GAO’s review, USDA shall
requires the reporting also of documented results of any
conduct a feasibility study of implementing a farmer
sampling and testing of a reportable food article and of a
indemnification program to provide restitution to producers for
component of a food article, including: tests conducted pursuant
incurred losses as a result of an erroneous mandatory recall.
to new § 418 (Hazard Analysis and Risk-Based Preventive
This report will be submitted to the House and Senate
Controls), new § 418A (Food Safety Plan), new § 419
Agriculture Committees.
(Performance Standards), or new § 714 (Testing by Accredited
•
The Secretary shal submit an annual report to the Senate
Laboratories); analytical results of facility environmental testing;
HELP and House Energy and Commerce Committees on the
or any other information deemed relevant by the Secretary.
use of recal authority under § 423. This report shal identify
This section does not amend the definition of “reportable food,” foods subject to a public health advisory; the number of
which establishes the reporting threshold. The Secretary must
responsible parties given an opportunity to cease distribution of
offer an alternative to electronic reporting for farms,
or recal a food; the number of recal orders; and a description
restaurants, and retail food establishments. Finally, § 112 of the
of instances in which there was no testing for adulteration.
bill contains extensive language on the conditions under which
Improving the Reportable Food Registry (§ 211)
food registry information may or may not be shared with or
disclosed to others including other agencies and to the public.
Amends FFDCA § 417 to require the Secretary to obtain from
a responsible party consumer-oriented information regarding
Note: The bill here references 21 CFR 1.227(b)(3) to define a
reportable foods (except for fruits and vegetables that are raw
farm as “... a facility in one general physical location devoted to
agricultural commodities), no later than 18 months after
the growing and harvesting of crops, the raising of animals
enactment: description of the food, affected product
(including seafood), or both. Washing, trimming of outer leaves
identification codes, contact information for responsible parties,
of, and cooling produce are considered part of harvesting. The
and other information deemed relevant by the Secretary. The
term ``farm'' includes: (i) Facilities that pack or hold food,
Secretary shall also prepare a one-page summary of the
provided that all food used in such activities is grown, raised, or
reportable food, to be available by internet and for grocery
consumed on that farm or another farm under the same
stores, as part of its notification process. If a grocery store sold
ownership; and (ii) Facilities that manufacture/process food,
a reportable food subject to posting, the store shal prominently
provided that all food used in such activities is consumed on that display such summary information for 14 days no later than 24
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S. 510 (Manager’s Amendment)
farm or another farm under the same ownership.” The bill here
hours after the one-page notification is published. Within one
also makes the same reference to define a retail food
year of enactment, the Secretary shall publish a list of
establishment.)
“conspicuous locations” for posting such notifications. Failure to
post a required notification is prohibited.
Administrative Detention of Food
Administrative Detention (§ 132)
Administrative Detention of Food (§ 207)
The Secretary has authority for the administrative detention of
Like the S. 510 manager’s amendment, this section amends
This section amends FFDCA § 304(h) in two ways. First, the
foods pursuant to FFDCA §§ 304(h) and 801. Under FFDCA §
FFDCA § 304(h) to requirement for “credible evidence or
requirement for “credible evidence or information” is lowered
304(h), an FDA officer or qualified employee may order the
information” to “reason to believe” and amends the standard of
to “reason to believe.” Second, the standard “a threat of serious
detention of an article of food for up to 30 days if the FDA
“a threat of serious adverse health consequences or death to
adverse health consequences or death to humans or animals” is
official “has credible evidence or information indicating that such humans or animals” to “adulterated or misbranded,” but the
changed to “adulterated or misbranded.” Thus, FFDCA §
article presents a threat of serious adverse health consequences
House-passed version of H.R. 2749 also adds “or otherwise in
304(h)(1)(A) would read: “An officer or qualified employee of
or death to humans or animals.” The detention request must be
violation of this Act.” Unlike S. 510, the House bill extends the
the Food and Drug Administration may order the detention . . .
approved by the Secretary or the Secretary’s designated official.
maximum period to detain an article of food under § 304(h)
of any article of food that is found during an inspection,
Detention orders may be appealed to the Secretary.
from 30 days to 60 days; strikes a sentence regarding how a
examination, or investigation under this Act conducted by such
subsection may be construed regarding delivery of an article of
officer or qualified employee, if the officer or qualified employee
Under FFDCA § 801, FDA officers and qualified employees must food pursuant to the execution of a bond while the food is
has reason to believe that such article is adulterated or
request the Secretary of Homeland Security to hold food at the
subject to a detention order; and extends the time al owed for
misbranded.” Within 120 days of enactment, the Secretary shal
port of entry for up to 24 hours if they possess “credible
the Secretary to act after an appeal of a detention order has
issue an interim final rule to implement the amended authority,
evidence or information indicating that an article of food
been filed from 5 days to 15 days. The Secretary is required to
and the amendments to FFDCA § 304(h) shal be in effect 180
presents a threat of serious adverse health consequences or
issue regulations or guidance to implement the amendments,
days after enactment.
death to humans or animals,” and that officer or qualified
and the amendments shall take effect 180 days after enactment.
employee “is unable to inspect, examine, or investigate such
article upon the article being offered for import.” The request
to hold the food must be approved by the HHS Secretary or his
or her appropriately designated official. 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.
Intentional Adulteration and Domestic Food Defense
Hazard Analysis, Risk-Based Preventive Controls, Food
Protection Against Intentional Adulteration (§ 106)
Safety Plan, Finished Product Test Results from
Intentional adulteration of foods can occur due to terrorism or
Category 1 Facilities (§ 102)
Subsection (a) of this section establishes a new FFDCA § 420,
out of economic motivation. Examples of the latter include
requiring the Secretary, within 18 months of enactment, in
findings in early 2007 of melamine in pet food ingredients from
Subsection (c) of this section establishes a new FFDCA § 418C,
coordination with the DHS and in consultation with USDA, to
China. Melamine—apparently added to boost the ingredients'
Food Defense, requiring the owner, operator, or agent of a
promulgate regulations to protect against the intentional
protein readings—sickened or killed many dogs and cats in
facility to develop and implement a written food defense plan
adulteration of food subject to this act. Regulations shal apply
North America. The ingredients subsequently were found in
before introducing any shipment of food into interstate
only to food: (1) for which the Secretary has identified clear
some hog, chicken, and fish feed. Although a risk assessment by
commerce. Lists required elements of the plan, including an
vulnerabilities; and (2) that is in bulk form rather than final
FDA and USDA indicated the problem posed virtual y no risk to
assessment to identify conditions and practices that may permit
packaging. To make such determinations, the Secretary shall
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humans, melamine turned up again in 2008 in milk products,
a hazard to be intentionally introduced, a description of
conduct vulnerability assessment of the food system (including
milk-derived ingredients, and finished food products containing
preventive measures to minimize such risks and of corrective
consideration by DHS), considering uncertainties, risks, costs,
milk from China.
actions to be taken if necessary, and other elements.
benefits, available mitigation strategies, and other factors. This
section shal not apply to food produced on farms, except for
FFDCA § 801(h) and (i), regarding imports and exports, require
Defines “hazard” for the purposes of this section. Authorizes
milk. Failure to comply with the requirements of this subsection
the Secretary to increase the number of import inspections,
the Secretary to require by regulation or guidance the adoption
is prohibited.
giving greatest priority to the detection of intentional
of preventive measures for specific product types; allows for
adulteration of food, and to improve information management
alternative measures to be approved by the Secretary; contains a Subsection (b) of this section requires the Secretary, within one
systems and develop rapid detection methods to serve this
number of reassessment, plan revision, recordkeeping, and
year of enactment, to issue appropriate guidance regarding the
purpose. FDA’s current food regulations do not specifically
records access requirements similar to those that facilities must
requirements of this section, and authorizes the Secretary, in
address intentional contamination of foods. FDA has published
follow under this section of the bill when developing and
coordination with the Secretaries of DHS and USDA, to issue
some guidance documents regarding protection of the food
implementing hazard prevention plans for unintentional
guidance documents related to protection against intentional
supply from intentional contamination. The agency also has an
contamination.
food adulteration. These guidance documents and the
internal work group on intentional economic adulteration and
vulnerability assessment of the food system may require limited
conducted, on May 1, 2008, a public meeting on the issue.
distribution due to national security concerns. The Secretary
will periodically review required regulations and guidance
There is currently no statutory requirement for the
required by this section, and update them if needed.
development of a comprehensive agriculture and food defense
strategy. There are, however, other examples of required,
National Agriculture and Food Defense Strategy (§ 108)
comprehensive, quadrennial reviews of this type. The
Quadrennial Defense Review is perhaps the best-known
Within one year of enactment, the Secretary and the Secretary
example. The Implementing Recommendations of the 9/11
of Agriculture, and in consultation with the Secretary of
Commission Act of 2007 (P.L. 110-53) requires the Secretary of
Homeland Security, shal prepare a National Agriculture and
the Department of Homeland Security (DHS) to routinely
Food Defense Strategy, to be submitted to relevant
conduct a Quadrennial Homeland Security Review, beginning in
congressional committees and made public on USDA and HHS
FY2009. The Pandemic and Al -Hazards Preparedness Act (P.L.
websites (in a manner consistent with national security
109-417, December, 2006) requires the Secretary of HHS to
interests). The strategy shall include an implementation plan and
routinely prepare a quadrennial National Health Security
a research agenda, and be consistent with the National Incident
Strategy and implementation plan, beginning in 2009.
Management System; the National Response Framework; the
National Infrastructure Protection Plan; the National
“In November 2002, Congress passed legislation creating [DHS].
Preparedness Goals; and other relevant national strategies. The
Among its responsibilities is overall coordination of critical
strategy must be revised at least every four years. The strategy
infrastructure protection activities....In June 2006, the Bush
shall describe the process by which HHS, DHS, and USDA will
Administration released a National Infrastructure Protection
achieve a set of goals laid out in this act, and evaluate the
Plan. This Plan presents the process by which the Department of
progress made by federal, state, local, and tribal governments
Homeland Security intends to identify those specific assets most
towards achieving those goals. The act lists 17 specific goals,
critical to the United States, across al sectors, based on the risk
covering preparedness, detection, emergency response, and
associated with their loss to attack or natural disaster, and then
recovery.
to prioritize activities aimed at maximizing the reduction of
those risks for a given investment.” (Source: CRS Report RL
Food and Agriculture Coordinating Councils (§ 109)
30153, Critical Infrastructures: Background, Policy, and
Requires the Secretary of Homeland Security, in coordination
Implementation, by John D. Moteff.) At present, DHS has
with the Secretaries of HHS and Agriculture, within 180 days of
identified several critical infrastructure and key resources
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sectors, including “Agriculture and Food.” For each sector, a
enactment and annual y thereafter, to report on the activities of
Government Coordinating Council and a (private) Sector
the Food and Agriculture Government Coordinating Council
Coordinating Council have been established to share data and
and the Food and Agriculture Sector Coordinating Council,
best practices, and to support risk-based planning.
regarding their progress in facilitating public-private
partnerships; facilitating information exchange; developing best
With regard to building domestic capacity, in general,
practices for coordinated preparedness and response; and
requirements in this section are not explicit in current law, but
means to protect the U.S. economy and public health in the
the Secretary would not be prohibited from undertaking these
event of a food or agricultural incident.
assessments and reporting the findings.
Building Domestic Capacity (§ 110)
FDA has initiated a number of activities focusing on economic
adulteration of foods and other products it regulates, including
Establishes a number of assessment and reporting requirements
the establishment of an internal working group.
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 shal include a list and description of projects conducted
during the previous two-year period, and the plan for projects
to be conducted in the following 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
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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.
State and Local Food Safety Roles and Training
Support for Training Institutes (§ 214)
Improving the Training of State, Local, Territorial, and
Tribal Food Safety Officials (§ 209)
Although federal agencies such as the FDA and FSIS have
Requires the Secretary to provide financial and other assistance
national responsibility for food safety under their respective
to appropriate entities to establish and maintain at least one
Creates a new FFDCA § 1011 which requires the Secretary to
authorizing statutes, state and local food safety agencies (usually
university-affiliated institute to train federal, state and local
set standards and administer training and education programs
located within health, agriculture, or environment departments)
officials in food protection activities.
for employees of state, local, territorial, and tribal food safety
have long played major, and in some cases lead, roles, with
authorities relating to their responsibilities under the FFDCA,
responsibility for illness surveillance, response to local
and authorizes the Secretary to enter into examination, testing,
outbreaks, and inspection and oversight of food safety and local
and investigations partnerships with such officials and their
public health laws in restaurants and grocery stores. Often these
employees.
activities may be conducted in col aboration, or under contract,
with federal authorities. Notable examples include the Grade A
The Secretary shall coordinate with USDA’s extension activities
Pasteurized Milk Ordinance and the National Conference of
of the National Institute of Food and Agriculture (NIFA) in
Interstate Milk Shipments (where federal authorities collaborate
advising producers and smal processors of new requirements
with state authorities and the milk industry to ensure the safety
under this act. Also, the Secretary, within 180 days of
of milk shipped in interstate commerce), the National Shellfish
enactment, shall enter into agreements with the Secretary of
Sanitation Program (a federal-state program to ensure the safety
Agriculture to provide competitive training and technical
of shellfish), and FDA-state contract inspection agreements
assistance grants, through NIFA, for farmers, smal food
(where states conduct facility inspections for FDA).
processors, and smal fruit and vegetable merchant wholesalers,
in accordance with § 405 of the Agricultural Research,
Currently no specific legislative language authorizes support for
Extension, and Education Reform Act of 1998 (AREERA), as
a training institute. FDA does provide funding to state and local
established by this act (see below). There are authorized to be
agencies through various grants and cooperative agreements to
appropriated for new FFDCA §1011 such sums as necessary for
help them conduct such activities as food defense, laboratory
FY2011-FY2015.
improvements, and food safety training; this funding totaled
approximately $11.4 million in FY2008 and was in addition to an
Creates a new AREERA § 405, “National Food Safety Training,
estimated $8 million states received for FDA contracts to
Education, Extension, Outreach and Technical Assistance
conduct food inspection that year
Program.” The Secretary of Agriculture shall, through NIFA,
award competitive grants to carry out the program authorized
Source: Stronger Partnerships for Safer Food: An Agenda for
above, as specified. Priority shall be given to projects for small
Strengthening State and Local Roles in the Nation’s Food Safety
and medium-sized farms, beginning farmers, social y
System, accessed February 3, 2010 at http://www.rwjf.org/files/
disadvantaged farmers, smal processors, or smal fresh fruit and
research/20090417foodsafetyfinalreport.pdf.
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
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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 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 shall 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 Excellence” 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.
Whistleblower Protection
Whistleblower Protections (§ 212)
Employee Protections (§ 402)
A variety of federal and state measures have been adopted to
Creates a new FFDCA § 911, “Protections for Employees Who
Creates a new FFDCA § 1012 prohibiting food businesses from
protect so-called whistleblowers, or those employees who
Refuse to Violate, or Who Disclose Violations of, This Act or
discharging or otherwise discriminating against an employee who
disclose information about illegal or improper activity, generally
Section 351 of the Public Health Service Act.” Extensive
provides or causes to be provided information relating to
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at their place of employment. Many federal employees, for
language here makes it illegal to “discharge, demote, suspend,
violations of the FFDCA; who testifies, assists, or participates in
example, are covered by the Whistleblower Protection Act (P.L. threaten, harass, on in any other manner discriminate against an
a proceeding on such a violation; or who refuses to participate
101-12). The FFDCA itself contains no such language regarding a employee in the terms and conditions of employment” if such an in an activity reasonably believed to violate the act. Contains
private employee who must, or willingly provides, information
employee provides information on a food, relating to a possible
extensive (but different from House) language on the
related to an FDA-related product.
violation of the FFDCA or the Public Health Service Act .
procedures for treating and protecting whistleblowers.
Seizure of FDA-Regulated Products
Procedures for Seizure (§ 131)
No comparable provision.
FFDCA § 304 spells out the grounds, jurisdiction, and
Appears to expedite the process for seizing adulterated or
procedures to be used to seize FDA-regulated products through misbranded articles of food by altering the current statutory
a court order. (This extensive FFDCA provision and the
procedures for doing so.
implementing steps involved are detailed in FDA’s Regulatory
Procedures Manual at http://www.fda.gov/ICECI/
ComplianceManuals/RegulatoryProceduresManual/default.htm.)
Quarantine Authority
Authority to Prohibit or Restrict the Movement of Food No comparable provision.
(§ 133)
The seizure provisions of FFDCA § 304 do not appear to
specifically authorize geographical quarantines of an article of
Amends FFDCA § 304 (seizure section) by adding that where
food in the United States.
the Secretary, after consulting with the Governor or other
appropriate state elected official, “determines that there is
On occasion, FDA does subject certain imports or groups of
credible evidence or information that an article of food presents
imports from an entire country or region to “detention without an imminent threat of serious adverse health consequences or
physical examination” until the importer can demonstrate that
death to humans or animals,” the Secretary is authorized to
the product satisfies FDA requirements. Examples of this in
prohibit or restrict the movement of the article of food within
2007 were imports of al Chinese plant protein products
the state or a portion of it. The Secretary must determine that
(including wheat gluten and rice gluten) after some were found
“there is no less drastic action that is feasible and that would be
to contain melamine, an unapproved substance; and of al farm-
adequate to prevent the imminent threat of serious adverse
raised shrimp, catfish, basa, dace, and eel from China until the
health consequences or death to humans or animals.”
shippers of these products could demonstrate that they were
free of unapproved drug residues.
Violation of a prohibition or restriction is a prohibited act under
FFDCA § 301. The remainder of § 133 describes the notification
procedures the Secretary must follow (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
Criminal Penalties (§ 134)
No comparable provision.
Under FFDCA § 301(a) (as adjusted by 18 U.S.C. §§ 3559 and
Any person who knowingly violates specified prohibited acts
3571) the maximum criminal penalty for individuals convicted of
under FFDCA § 301 would be subject to increased penalties, of
a misdemeanor under the act is $100,000 if it does not result in
up to 10 years in prison and/or fines in accordance with the U.S.
death; $250,000 if it results in death; and/or imprisonment of
Criminal Code (Title 18 of the U.S.C.). This section also
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one year. The maximum criminal misdemeanor penalty for
requires the revision of penalties for violations of the FFDCA.
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.
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
Civil Penalties for Violations Relating to Foods (§ 135)
No comparable provision.
FFDCA § 303(f)(2) FFDCA subjects any person who
Amends FFDCA § 303(f)(2) ) to delete restrictions on civil
“introduces into interstate commerce or delivers for
penalty provisions regarding pesticide chemical residues that
introduction into interstate commerce an article of food that is
result in a food being deemed adulterated under FFDCA §
adulterated within the meaning of [FFDCA] section
402(a)(2)(B). It also amends § 303(f)(2) by authorizing the
402(a)(2)(B)” to a civil monetary penalty of up to $50,000 if an
Secretary to assess a civil penalty of up to $20,000 (not to
individual and up to $250,000 on any other person, to a
exceed $50,000 in a single proceeding) on an individual and of
maximum of $500,000 for al such violations adjudicated in a
up to $250,000 on any other person (not to exceed $1 million
single hearing. However, 402(a)(2)(B) applies only to the
in a single proceeding) for committing a violation of FFDCA §
presence of illegal pesticide residues. The section further
301 (prohibited acts). For knowing violations, maximum civil
exempts from this penalty any person who grew the article of
penalties for individuals are $50,000 (not to exceed $100,000 in
food, and it prohibits use of FDA’s seizure, injunction, or
a single proceeding), and for any other person $500,000 (not to
criminal authorities if such a civil monetary penalty is assessed.
exceed $7.5 million in a single proceeding). Each prohibited act
and each day is to be considered a separate offense. The
Currently, there are no maximum civil penalties tied to FFDCA
rewording of this section appears to effectively broaden the
§ 303(a), which addresses criminal penalties for prohibited acts
reasons for which civil penalties could be applied; subjects those
under the FFDCA.
growing an article of food that is adulterated under §
Obama Administration: The Hamburg and Taylor
402(a)(2)(B) to them; and appears to no longer preclude use of
testimonies express support for § 135 of the House bill.
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.
False or Misleading Reporting
False or Misleading Reporting to FDA (§ 210)
No comparable provision.
FFDCA § 301delineates prohibited acts under the law, one of
Expands the FDA-regulated products covered by this prohibited
which is “With respect to any device, the submission of any
act to include a “food, drug, or biological product.”
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report that is required by or under this Act that is false or
misleading in any material respect.” [§ 301(q)(2)].
FDA Subpoena Authority
Subpoena Authority (§ 211)
No comparable provision.
The FFDCA provides authority for issuing subpoenas under
Expands subpoena authority by permitting the FDA
certain specified conditions. For example, in the course of an
Commissioner to issue subpoenas for witnesses and “the
investigation or hearing leading to either civil penalties or
production of records and other things” for the purpose of any
withdrawal of approval for violations of the law related to drug
hearing, investigation, or other proceeding on a violation of the
applications under §§ 335(b) and 335(c), the Secretary is
FFDCA. This section contains extensive language on the timing
authorized, among other things, to issue subpoenas requiring
of compliance and service of a subpoena, among other things.
attendance of witnesses and production of evidence. Similar
authorities are provided 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).
Food Decontamination and Disposal
No comparable provision.
Decontamination and Disposal Standards and Plans (§
208)
Depending on the type(s) of contaminant and the type(s) of food
involved, several federal agencies and a variety of laws may be
Requires the Administrator of the Environmental Protection
involved in various steps in the process of decontamination,
Agency (EPA), in coordination with the Secretaries of HHS,
disposal, and/or remediation following an agriculture or food
DHS, and USDA, to provide support and technical assistance to
emergency. In addition to agencies that provide scientific and
state, local, and tribal governments in preparing for, assessing,
technical assistance—particularly EPA, and various agencies in
decontaminating, and recovering from an agriculture or food
DHS, HHS, and USDA—the Federal Emergency Management
emergency. Activities shall include: (1) the development and
Agency (FEMA) may be involved if the incident is sufficiently
dissemination of standards and protocols; (2) jointly developed
large in scope, and the Federal Bureau of Investigation may be
model plans for the decontamination of individuals, equipment,
involved if it resulted from a deliberate act. In addition, state
and facilities following an intentional incident, and the disposal of
authorities may play a leading role, and may seek technical and
large quantities of infected or contaminated animals, plants, or
other assistance from appropriate federal agencies. Several
food products; and (3) the conduct of annual exercises,
Emergency Support Function annexes in FEMA’s National
consistent with the mandated DHS national exercise program.
Response Framework provide insights into the possible roles
Based on findings from exercises, model plans shal be updated
and coordination of various federal agencies in response to an
at least biennially. The development of standards and plans shall
agriculture or food emergency.
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
Certification and Accreditation (§ 109, part)
Authority to Require Import Certifications for Food (§
303)
The steady increase in food imports, a result of globalization and Amends FFDCA § 801 by authorizing the Secretary to require,
consumer desire for a wider variety of foods year-round, has
as a condition of granting admission for an imported food article, Amends FFDCA § 801 by authorizing the Secretary to require
generated growing concerns about whether current federal
that a “qualified certifying entity provide a certification that the
certification or other assurance of the safety of an article of food
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programs sufficiently ensure the safety of these imports. Most of article complies with specified requirements” of the FFDCA.
imported or offered for import, and to deny entry to any food
the recent debate has included extensive discussion about how
This requirement is to take effect on or after three years from
offered for import that does not meet such a requirement. The
to improve current import safeguards, within resource
date of enactment. However, the Secretary must only require
Secretary may base such a requirement on public health
constraints, and without unduly restraining free trade.
such certification in the following situations:
considerations, including risks associated with the food or its
place of origin. Such certification shall be used for designated
Current law does not explicitly authorize, or require, any
•
For food imported from a particular country, territory, or
food imported from countries with which the FDA has an
certification of imports, and whether FDA has what is often
region, where the Secretary finds based on scientific risk-based
agreement to establish a certification program. Certifying
cal ed “equivalence authority" has been a matter of debate (also
evidence that the government controls there are inadequate and entities—those who may provide certification or assurances—
see below). Regardless, it does not have a program like that of
that such certification would assist in determining the
include an agency or a representative of the government of the
FSIS, which many consider to be a form of certification. Under
admissibility of the food;
country from which the article of food at issue originated, as
the FMIA and PPIA, no foreign establishment can ship its
designated by such government or the Secretary; or such other
products to the United States until FSIS has determined that the
•
For a food type for which there is scientific evidence that
persons or entities accredited to conduct audits, pursuant to §
establishment’s country has a meat and/or poultry safety
there is a particular risk that presents a threat of serious
808, as established by this act, to provide such certification or
program that provides a level of protection that is at least
adverse health consequences or death and that such certification assurance. The Secretary may require periodic renewal, or
equivalent to the U.S. system. FSIS visits the exporting country
would assist in determining whether the article poses such risk;
determine that a current certification is not valid. The Secretary
to review its rules and regulations, meets with foreign officials,
or
shall provide for electronic submission of required certifications.
and accompanies them on visits to establishments. In addition,
•
For an article imported from a particular country or
Certifying agents who make false statements shall be subject to
FSIS operates a reinspection program at 150 import houses
territory, if the Secretary has an agreement with that
criminal fines or imprisonment pursuant to 18 U.S.C. § 1001. If
located near approximately 35 border entry points. Some have
government providing for such certification.
the Secretary determines that the food safety systems of a
suggested that the FDA program should operate more like that
foreign country or region do not meet the requirements of this
of FSIS, although they acknowledge the difficulties and resource
The Secretary, in coordination with the Commissioner for
section, the Secretary shall, to the extent practicable, identify
demands of attempting to regulate many more different types of
Customs and Border Protection, shall provide for the electronic
such inadequacies and a means for the country or region to
foods from many more countries of origin.
submission of certifications. A certification may take the form of
a statement that the article, or the facility or farm “that
notify the Secretary of subsequent improvements. Amendments
Obama Administration: Dr. Hamburg’s testimony expresses
manufactured, processed, packed, held, grew, harvested, sorted,
made by this section shall not limit the Secretary’s authority to
support for relying not only on foreign governments for
or transported” it, complies with FFDCA requirements as
conduct inspections of imported food or to take such other
international inspections but also having the flexibility to
specified by the Secretary, or take any other form specified by
steps as the Secretary deems appropriate to determine the
explore use of an accreditation system and audit the
the Secretary including a listing of certified facilities or other
admissibility of imported food.
performance of accredited third parties.
entities.
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
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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.”
Inspection of Foreign Facilities
Prohibition Against Delaying, Limiting, or Refusing
Inspection of Foreign Food Facilities (§ 306)
Inspection (§ 207); Risk-Based Inspection Schedule (§
FFDCA § 704 authorizes officers and employees designated by
105)
Amends FFDCA Chapter VIII (regarding imports and exports),
the Secretary of HHS to, among other things, enter and inspect
adding a new § 807, authorizing the Secretary to enter into
“any factory, warehouse, or establishment in which food, drugs,
Amends FFDCA § 402 by newly considering a food adulterated if arrangements and agreements with foreign governments to
devices, or cosmetics are manufactured, processed, packed, or
it is from any farm, factory, warehouse, or establishment and the facilitate the inspection of foreign facilities registered under
held, for introduction into interstate commerce or after such
owner, operator, or agent,” or any agent of a governmental
FFDCA § 415; and requiring the Secretary to direct resources
introduction.” Inspections must be conducted “at reasonable
authority in the foreign country, “delays or limits an inspection
to inspections of foreign facilities, suppliers, and food types,
times and within reasonable limits and in a reasonable manner.”
or refuses to permit entry or inspection” under FFDCA § 414
especially such facilities, suppliers, and food types that present a
The refusal to permit such inspections is prohibited under
(records inspection) or § 704 (factory inspection). (The
high risk (as identified by the Secretary), to help ensure the
FFDCA § 301. “Interstate commerce” is defined under FFDCA § remainder of the bill’s § 203 consists of similar proscriptions for
safety and security of the food supply of the United States.
201 to mean “(1) commerce between any State or Territory and drugs, devices, and cosmetics.)
any place outside thereof, and (2) commerce within the District
Imported foods shall be refused admission if “from a foreign
of Columbia or within any other Territory not organized with a
The general risk-based inspection provisions in § 105 (above)
factory, warehouse, or other establishment of which the owner,
legislative body.” A “factory, warehouse, or establishment” is
apply to both imported and domestic inspections. As noted
operator, or agent in charge, or the government of the foreign
not defined in the FFDCA; nor does there appear to be any
above, §105 requires foreign facilities to be inspected by an
country, refuses to permit entry of United States inspectors or
statutory distinction here between foreign and domestic.
agency or representative of a foreign country that is recognized
other individuals duly designated by the Secretary, upon request,
Although the FFDCA appears neither to expressly include nor
by the Secretary as meeting U.S. standards. (See also § 208 of
to inspect such factory, warehouse, or other establishment,” if
to expressly exclude foreign facilities with regard to the right of
the House bill, below.)
an inspection is refused “during the 24-hour period after such
inspection by the HHS Secretary or designee, the Bush
request is submitted, or after such other time period, as agreed
Risk-Based Inspection Schedule (§ 105, part);
Administration had argued that FDA lacks the authority to
upon by the Secretary and the foreign factory, warehouse, or
Certification and Accreditation (§ 109, part)
refuse food imports when the agency has been denied access to
other establishment.’’
a foreign facility.
The Secretary has authority under § 105 (Risk-Based Inspection
The Secretary of Commerce, in coordination with HHS, may
Schedule) to “recognize Federal, State, and local officials and
Note: Whether FDA now has what is often called “equivalency
send one or more inspectors to a country or facility of an
agencies and representatives of foreign countries as meeting
authority” is a matter of debate. “In a May 9, 2007 hearing
exporter of seafood imported to the United States. The
standards established by the Secretary for conducting
before the House Agriculture Committee, FDA’s chief food
inspection will assess the practices used in connection with the
inspections” under the FFDCA (recognition for such inspections
officer, David Acheson, responded to a question that the agency
farming, cultivation, harvesting, preparation for market,
could be limited to specific commodities or food types); and
theoretically has the authority to require equivalency for
transportation of the seafood; technical assistance may be
under § 109 (accreditation of third-party certifying agents),
imports but that FDA’s situation is significantly more complex
provided for such activities. The Secretary, coordinating with
whereby a foreign government may be eligible to be a qualified
than USDA’s.... [The Government Accountability Office] had
the Secretary of Commerce, shall prepare an inspection report,
certifying agent.
suggested in 1998 that border inspections alone were
which will also be provided to the exporter who will be given 30
ineffective, but that FDA lacks the authority to mandate
Before requiring certification under § 109, (see above), the
days to provide a rebuttal or comments to HHS.
equivalency.” However, FDA has visited certain importing
Secretary must establish a process for a country or territory to
countries at their invitation to conduct such reviews, suggesting
demonstrate that its controls are adequate to ensure that a food
that current authority does not bar the Secretary from
destined for the United States is safe. The Secretary cannot
require a certification for a food from a country or territory
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conducting such assessments.
that has made such a demonstration. The application of these
certification requirements must be consistent with U.S.
FSIS has import equivalency authority, in that most meat,
international obligations.
poultry, and processed egg products may only be imported from
countries that have demonstrated to FSIS that they maintain
regulatory protections for specified products that 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.”
Foreign Supplier Verification
Registration for Commercial Importers of Food; Fee (§
Foreign Supplier Verification Program (§ 301)
204); Registration for Customs Brokers (§ 205); Unique
The FFDCA does not explicitly authorize, and does not require,
Identification Number for Food Facilities, Importers
Amends FFDCA Chapter VIII (regarding imports and exports)
the establishment of a foreign supplier verification program. The
and Customs Brokers (§ 206)
by adding a new § 805, effective two years after the date of
FFDCA also does not require those who are importers or
enactment, requiring each importer to establish risk-based
import brokers to register with FDA under the food facility
These sections require an importer of foods to register annually
foreign supplier verification activities. Importing, or offering for
registration provisions of § 415. At a House Energy and
with the Secretary and to submit an appropriate unique facility
importation, a food by an importer who does not have such a
Commerce Committee hearing on June 3, 2009, U.S. officials
identification as a condition of such registration. Further
program in place is prohibited under FFDCA § 301, and the
acknowledged that they had no firm data on the number of
conditions for importers (but not customs brokers) include
Secretary shall refuse admission to any such product that
entities that import food.
compliance with “good importer practices.” Among other
appears to be in violation of this requirement. Defines an
provisions in this section is a requirement that importers permit
importer as the U.S. owner or consignee of the article of food at
Obama Administration: The Hamburg and Taylor
an officer or employee of the Secretary to “inspect the facilities
the time of entry of such article into the United States; or the
testimonies express support for § 204 of the House bill.
of such person and have access to, and to copy and verify, any
United States agent or representative of a foreign owner or
related records.”
consignee of the article of food at the time of entry of such
article into the United States.
The Secretary (in consultation with Customs and Border
Protection) must promulgate regulations on the measures an
The importer is required to develop a program that: (1) assures
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importer must take to ensure that the importer has adequate
that imported food is not adulterated or misbranded; and (2)
information about a food, its hazards, and applicable
complies with the program of hazard analysis and preventive
requirements; the ability to verify that both the food and each
controls in FFDCA § 418, or the produce safety requirements in
person who produced, manufactured, processed, packed,
FFDCA § 419, each as established by this act. Within one year of
transported, or held the food including its components are in
enactment, the Secretary shall issue guidance and promulgate
compliance; and procedures to take corrective actions regarding regulations regarding the development of foreign supplier
noncompliant foods. This provision also authorizes the
verification programs, including appropriate verification steps
Secretary, in promulgating good import practices regulations, to
that importers may apply to the products of their foreign
incorporate certification of compliance under FFDCA § 801(q)
suppliers, to assure that safety requirements are met. The
and participation in the safe and secure food importation
importer shall maintain appropriate documentation for not less
program under FFDCA § 805, and to take into account
than two years, and make such records available for inspection.
differences among importers and types of imports.
Importers of seafood, juice, or low-acid canned food whose
products are currently in compliance with FDA’s relevant
Provisions in this part of the bill provide for conditions for
standards and regulations are deemed to be compliant with this
suspending registrations, and for exemptions from the
section. The Secretary shall publish and maintain a current list of
requirements by the Secretary, among other things. Failure to
participating importers.
register is prohibited under FFDCA § 301; any food 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). Fees are discussed later
in this comparison.
Improper Import Entry Filings (§ 136)
This different but somewhat related 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.
Expediting Imports
Safe and Secure Food Importation Program (§ 113)
Voluntary Qualified Importer Program (§ 302)
The FFDCA does not explicitly provide authority for expediting
Amends FFDCA Chapter VIII (regarding imports and exports),
Amends FFDCA Chapter VIII (regarding imports and exports),
imports. Among the questions raised during the policy debate:
adding a new § 805, which appears to leave more aspects of
adding a new § 806. It requires the Secretary, within 18 months
Should importers, or those foreign facilities which supply them,
implementation to the Secretary’s discretion than does the
of enactment: (1) to establish, in consultation with the Secretary
that have good histories of compliance with U.S. food safety
expedited import program proposed in S. 510. This section
of Homeland Security, a voluntary program to expedite review
laws, and/or that import relatively low-risk foods, be permitted
authorizes the Secretary ( in coordination with Customs and
and importation of foods from qualified importers; and (2) to
to follow abbreviated procedural requirements? If so, what if any Border Protection) to establish a program to facilitate the
issue applicable program guidance. An importer is defined in this
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additional standards should they have to meet?
movement of food through the import process, if the importer
section as “the person that brings food, or causes food to be
verifies that each facility involved in its production, manufacture,
brought, from a foreign country into the customs territory of
processing, packaging, and holding is in compliance with safety
the United States.” An importer that intends to participate in
and 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 also
notice to the Secretary of such intent at time and in a manner
is to ensure that appropriate safety and security controls are in
established by the Secretary. Eligibility is limited to an importer
place throughout the supply chain and to provide supporting
who offers for importation a food from a facility that has a
information to the Secretary.
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, 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.
FDA Foreign Offices
Dedicated Foreign Inspectorate (§ 208)
Foreign Offices of the Food and Drug Administration (§
308)
The FFDCA neither prohibits nor requires the establishment of
Amends FFDCA § 704 (in the General Authority chapter) to
FDA field offices in other countries. FDA reports that it is
require the Secretary to establish and maintain a corps of
The Secretary is required, in consultation with the Secretaries of
establishing offices in China, Latin America, India, Europe, and
inspectors dedicated to inspecting foreign food facilities. This
State and Homeland Security and the United States Trade
the Middle East, and was implementing a Memorandum of
corps is to be staffed and funded at a level to assist the
Representative, to establish FDA offices in foreign countries
Agreement with China, in order to coordinate food safety
Secretary to achieve the frequency of inspections for food
selected by the Secretary, to assist the appropriate
activities.
facilities described in this act.
governmental entities of those countries regarding measures to
provide for the safety of food and other FDA-regulated
products exported by those countries 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
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foreign offices. Clarifies that nothing in this provision shall affect
the Secretary’s authority to issue public notifications under
other circumstances.
Country of Origin Labeling
Country of Origin Labeling (§ 202)
No comparable provision.
Since the 1930s, § 304 of the Tariff Act of 1930, as amended, has Amends the misbranding provision of FFDCA § 403 to consider
required most imports to carry labels so that the “ultimate
a processed food misbranded if its label fails to identify the
purchaser," usual y the retail consumer, can determine their
country in which final processing occurred. A non-processed
country of origin. Certain products, including a number of
food is misbranded if its label fails to identify the country of
agricultural commodities in their "natural" state such as meats,
origin. Processed foods and non-processed foods are deemed to
fruits and vegetables, were excluded. Effective in 2009, many
meet the requirements of this section if they are subject to and
retail food stores are now required to inform consumers about
meet the requirements of, respectively, the U.S. Customs and
the country of origin of fresh fruits and vegetables, seafood,
Border Protection or USDA. The Secretary is required to
peanuts, pecans, macadamia nuts, ginseng, and ground and
promulgate final regulations on this provision within 180 days of
muscle cuts of beef, pork, lamb, chicken, and goat, under
enactment, and the new requirements take effect two years
provisions of the 2002 farm bill (P.L. 107-171) as amended by
after enactment.
the 2008 farm bill (P.L. 110-246).
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.
Prior Notice of Imports
No comparable provision.
Prior Notice of Imported Food Shipments (§ 304)
FFDCA § 801(m) requires the Secretary to establish, by
Amends the list of elements that must be provided in the notice
regulation, procedures and requirements by which an importer
required under FFDCA § 801(m) by adding the identity of “any
shall give FDA prior notice of shipments of food intended for
country to which the article has been refused entry.” Within
importation, in order that FDA can make determinations
120 days of enactment, the Secretary shal publish an interim
regarding the admissibility of the food. The FFDCA stipulates
final rule implementing this amendment, which shall take effect
certain required data elements that must be included in the
180 days after the date of enactment.
notice, including the country from which the food originated,
and the country from which the food is shipped. In November
2008, FDA published a final regulation to implement the current
authority. The final rule does not require that information be
provided regarding refusal of an article of food by another
country.
Foreign Capacity Building
No comparable provision.
Building Capacity of Foreign Governments with Respect
to Food (§ 305)
Current law would not prohibit the development of the plan
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proposed by this section of S. 510 (right). Implementation of
Requires the Secretary, within two years of enactment, to
certain elements of such a plan may be authorized under: (1)
develop a comprehensive plan to expand the technical, scientific,
FFDCA § 803, which authorizes an HHS Office of International
and regulatory capacity of foreign governments, and their
Relations to, among other things, reach agreements with other
respective food industries, from which foods are exported to
governments regarding practices and standards; and (2) PHS Act
the United States. In developing the plan, the Secretary shall
§ 307, authorizing col aborations with foreign governments for
consult with the Secretaries of Agriculture, State, Treasury,
the purposes of research and education regarding health-related
Homeland Security, and Commerce, the U.S. Trade
matters.
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
No comparable provision.
Smuggled Food (§ 309)
The FFDCA does not appear to address or to define the term
Requires the Secretary, within 180 days of enactment, in
“smuggled food,” although Chapter VIII of the act covers
consultation with designated officials in the Department of
imports and exports.
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.”
Port Shopping
No comparable provision.
Port Shopping (§ 115)
FFDCA section 801(n) provides FDA with the authority to help
Until the Secretary promulgates a final rule that implements the
prevent “port shopping,” whereby importers of refused goods
amendments made by section 308 of the Bioterrorism Act of
try to import through another port when refused entry at one
2002, requires the Secretary to notify the Secretary of
port. The provision authorizes FDA to require refused food to
Homeland Security of instances of import refusals under FFDCA
be marked with the statement “UNITED STATES: REFUSED
section 801(a) (Imports; list of registered foreign establishments;
ENTRY.” This authority was enacted in section 308 of the
samples from unregistered foreign establishments; examination
Bioterrorism Act of 2002 (P.L. 107-188)
and refusal of admission) to alert U.S. Customs and Border
Protection and prevent imports refused at one port from being
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admitted by another port.
Jurisdiction
Rules of Construction (§ 4)
Jurisdiction; Authorities (§ 403)
The preemption doctrine is derived from the Supremacy Clause
This so-called preemption provision states that “Nothing in this
Not a preemption provision; provides that this act, and any
of the U.S. Constitution, which establishes that the laws of the
Act or the Amendments made by this Act shal be construed to
amendment made by it, would not: (1) alter jurisdiction between
United States "shall be the supreme law of the land; and the
prohibit or limit—(1) any cause of action under State law; or (2)
HHS and USDA under applicable statutes, regulations, or
judges in every state shall be bound thereby, any thing in the
the introduction or evidence of compliance or noncompliance
agreements regarding products eligible for voluntary inspection
Constitution or laws of any State to the contrary
with” the FFDCA.
under the Agricultural Marketing Act (7 U.S.C. 1621 et seq.); (2)
notwithstanding." In general terms, federal preemption occurs
alter the jurisdiction between the Administration of the Alcohol
when a validly enacted federal law supersedes any inconsistent
Also clarifies that nothing in this act is to limit or otherwise alter and Tobacco Tax and Trade Bureau and the HHS Secretary; (3)
state law. Courts’ application of this may involve such factors as
the current jurisdiction or authorities between the Secretaries
limit the authority of the HHS or Agriculture Secretary under
whether or not a federal statute has explicitly stated Congress’
of HHS and of Agriculture, including those under the FFDCA,
specified existing statutes (including the FFDCA); or (4) impede,
intent on the matter, This issue is discussed regarding medical
Public Health Service Act, the FMIA, PPIA, or EPIA.
minimize, or affect the authority of the Secretary of Homeland
devices in CRS Report R40534, Riegel v. Medtronic, Inc.: Federal
USDA Exemptions (§ 5)
Security under the Homeland Security Act (6 U.S.C. 101 et
Preemption of State Tort Law Regarding Medical Devices with FDA
seq.).
Premarket Approval.
Explicitly exempts from this act foods and establishments to the
extent that they are regulated under the FMIA, PPIA, or EPIA.
Alcohol-Related Facilities (§ 116)
Separately, FFDCA § 902(b) general y exempts meat and meat
Exempts a farm “to the extent such farm raises animals from
food products from the provisions of the FFDCA; § 24 of the
Generally exempts from this ct (the manager’s amendment)
which” such foods are derived. Clarifies that livestock and
Poultry Products Inspection Act (PPIA) general y exempts
beverages and facilities that are primarily regulated under the
poultry intended for slaughter under the FMIA, PPIA, as well as
poultry and poultry products from FFDCA provisions.
Alcohol Administration Act. Certain of the act’s provisions are
milk-producing cows, sheep, or goats are exempt.
excepted from this exemption, including those related to
Alcohol
Alcohol-Related Facilities (§ 6)
registration, mandatory recall, and administrative detention,
among others; these provisions would apply to alcohol-related
The Federal Alcohol Administration Act (27 U.S.C. 201 et seq.)
Similar provision, except that it contains a shorter list of
beverages and facilities.
provides for regulation of those engaged in the alcohol beverage
provisions excepted from the exemption. Notably, mandatory
industry, and for the protection of consumers.
recal and administrative detention provisions are not excepted
Compliance With International Agreements (§ 404)
from the exemption. Therefore, they would not apply to
Nothing in this act shall be construed in a manner inconsistent
alcohol-related beverages and facilities.
with the agreement establishing the World Trade Organization
Extraterritorial Jurisdiction (§ 213)
or any other agreement or treaty to which the United States is a
party.
Makes the following a prohibited act under the FFDCA: “The
production, manufacture, processing, preparation, packaging,
holding, or distribution of an adulterated or misbranded food
with the knowledge or intent that such 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.”
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Funding and Fees
Various Sections (§ 101, § 108, § 203, § 204)
Authority to Collect Fees (§ 107)
Many critics argue that—irrespective of the need, if any, to
Authority to assess new types of food-related fees appear in
Authorizes FDA to col ect two types of fees related to food:
reform food safety statutes and organization—a fundamental
four sections of the House bill.
export certification fees and user fees. The export certification
problem has been the lack of sufficient funding and staff to carry
provisions in current law are amended to allow food exporters
out congressionally mandated (and existing) responsibilities to
Under § 101 (Changes in Registration of Food Facilities), the
to request that the Secretary certify that exported foods comply
ensure a safe food supply.
Secretary is required to assess and collect a facility registration
with provisions in the FFDCA, and would thus enable the
fee each year from facilities required to register under FFDCA §
associated fee to be charged to the exporter. The food user fees
Proposed increases in program spending raise a variety of policy
415. This fee is to be set at $500 per facility in FY2010; for
are established by inserting a new FFDCA § 743 : “Part 6–Fees
issues. Requests for higher appropriations always compete with
FY2011 and each subsequent fiscal year, the fee is to be adjusted Related to Food.” The new part authorizes, indefinitely, the
other priorities throughout the federal discretionary budget (the to reflect the cost of inflation, under a specified formula. § 101
assessment and col ection of four user fees:
programs do not operate, like farm support programs, for
also sets a maximum annual fee payment of $175,000 for those
example, as mandatory authorizations). Such requests currently
who have multiple facilities. Other provisions in this section:
•
fees paid by domestic facilities subject to a reinspection (to
are being made during a period of huge budget deficits. Efforts
require the Secretary to hold a public meeting each fiscal year to cover reinspection-related costs);
to fill perceived shortfalls through new fees on the food industry explain the fees’ use and to solicit stakeholder views; are
always meet with resistance, both from the companies that
intended to ensure that these fees do not supplant FDA
•
fees paid by domestic facilities and importers subject to
would have to absorb such costs, and from consumer advocates, appropriations or reduce HHS Department staffing; address
food recal s (to cover food recal activities performed by the
who have long argued that industry funds might compromise
their collection, crediting and availability vis a vis appropriations;
Secretary);
public health programs.
sunset the fees after FY2014; and require annual reports to
•
fees paid by importers participating in the voluntary
Congress. “Food safety activities” and “costs of food safety
Congressional appropriators have increased funding for FDA
qualified importer program (to cover administrative costs of the
activities” are extensively defined in this section. The provisions
food safety activities for FY2008 and FY2009. The Obama
program); and
in this section are modeled in part on existing user fee
Administration request for FY2010 cal s for a more than $1
authorities for drugs and devices.
•
fees paid by importers subject to reinspection (to cover
billion FDA food safety budget, which would be a $259 million
reinspection-related costs).
increase over the FY2009 level of $785 million. Of this increase,
Under § 108 (Reinspection and Food Recall Fees Applicable to
$165 million is proposed to come from new budget authority
Facilities), the Secretary is required to assess and collect a fee
Overdue fees are treated as claims of the United States
(appropriations) and $94 million through new fees on industry.
from each facility that either: violates any food-related
Government under 21 U.S.C. § 37. The Secretary is required to
These fees would include $75 million raised through an
requirement of the FFDCA and therefore must undergo
report annual y to Congress describing the entities paying fees,
apparently annual food inspection and facility registration fee,
additional FDA inspection; or is subject to a food recall. The
and the fees assessed and collected for each year.
$15 million raised through a re-inspection fee, and $4 million
Secretary must set the fee amount at a level to ful y cover the
The Secretary is required to establish and publish the fee
raised through export certification fees (see below for more on
reinspection and/or recall costs and use the collection solely for
amounts annual y, setting fees so that each one covers 100% of
the latter two fees). The FY2010 appropriations bills for USDA
that purpose. If the Secretary determines that a recall “was
the cost of the associated activity, with certain caveats. For the
(H.R. 2997/S. 1406) that have passed both chambers but not yet
inappropriately required,” the fee must be waived or refunded.
first five years that user fees are assessed, the Secretary is to
been enacted both ful y fund the President’s request, although
Other language here addresses their col ection, crediting and
include a surcharge in order to recoup the costs associated with
both appear to provide the money through new budget
availability vis a vis appropriations, with a sunset for the fees
establishing the user fee programs. Fees col ected for a given
authority rather than new user fees.
after FY2014.
fiscal year for food recall activities may not exceed $20 million.
In general, FDA’s fee-funded programs for drugs and devices
Under § 203 (Exportation Certificate Program), the Secretary is
Fees col ected for a given fiscal year for reinspection of both
have finite appropriations authorities that sunset, prohibiting the
authorized to impose a fee for food export certifications that
domestic facilities and importers may not exceed $25 million
agency from collecting fees beyond the authorized time frame.
meet the specifications of a foreign purchaser and that do not
combined. Despite these limitations, the Secretary may collect
These authorities do not apply to food safety programs at this
conflict with the destination country’s laws. (Such fees already
fees from facilities or importers who become subject to the fees
time. In addition, some discretionary-funded grant programs
may be charged for certifications of some other FDA-regulated
after the limitations are reached. The Secretary must credit to
have finite appropriations authorities, and may or may not
products.) The fee shal be “reasonably related” to the cost of
the following year any fees collected in excess of actual costs,
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continue to be funded if authority expires. But, in general, FDA’s issuing such certificates; this fee authority is permanent.
and adjust fee amounts for that following year to account for the
enforcement activities, such as those for food safety, are based
excess fees and other factors the Secretary determines are
in broad, permanent authorities in the FFDCA. These
Section 204 establishes a new FFDCA § 744, requiring the
appropriate.
authorities do not expire, and they are not accompanied by
Secretary to assess and col ect a $500 annual fee for the
authorized levels of appropriations. Decisions to apportion
registration of an importer of food, with administrative
The Secretary is authorized to collect fees only to the extent
annual appropriations among FDA’s various programs and
provisions somewhat comparable to those set under § 101
that amounts have been specified in advance in appropriations
activities are made through the annual appropriations process
(above). (This fee is to be tied to the new requirement that such acts. Additional “triggers” apply. Fees collected in a given year
without explicit directives in authorizing legislation.
importers begin to register with FDA within one year of
must be refunded unless appropriations to FDA for food safety
enactment.) Importers that already must pay the facility fee
activities are maintained at the FY2009 level, with specified
FDA is currently authorized to collect several types of fees.
under § 101 are exempt from this importer registration fee. This adjustments. Fees can be used solely to fund the specified food
Among them are user fees and export certification fees, neither
fee authority sunsets after FY2014.
safety activity.
of which may currently be collected for food-related activities.
FDA’s authority to col ect user fees extends to human
Note: The proposed food user fee is different from existing user
prescription drugs, medical devices, and animal drugs, under
fees in several ways. First, the proposed fee would be authorized
FFDCA Chapter VII, Subchapter C, §§ 735-740. General y, these
indefinitely, while each of the existing user fees have been
fees can only be used to fund the “process for the review of
authorized in five-year increments. Second, the fees would be
applications.” (FDA reviews applications to determine whether
used to fund inspection and enforcement activities for foods on
to permit drugs, medical devices, and animal drugs to be legally
the market. For other products, the existing user fees only fund
marketed. Prior approval is not required for most foods, which
application-review related activities, as defined in the law—
can be legally marketed without the agency’s prior permission.)
though, as noted above, FDA does not inspect foods before they
The user fee programs have been authorized in five-year
can be marketed as it does some of the other products that it
increments. Each authorization specifies the fee amounts FDA
regulates. Third, the act does not authorize specific fee levels in
may col ect annual y, and makes the authority to col ect these
advance, but rather allows the Secretary to set fee levels based
fees contingent upon “triggers,” which require that appropriated
upon estimated costs. For currently authorized fees, the
and internally allocated funding amounts for certain activities
amounts are articulated in law, either individually, or in
meet specified threshold levels.
aggregate, for a given type of fee.
FDA’s authority to collect export certification fees extends to
Funding for Food Safety (§ 401)
drugs, medical devices and biological products, according to
This section authorizes, for activities of FDA’s Center for Food
FFDCA § 801(e)(4). A person who exports a human drug,
Safety and Applied Nutrition, Center for Veterinary Medicine,
animal drug, or device may request that the Secretary certify in
and related field activities in the Office of Regulatory Affairs,
writing that the product meets FFDCA requirements. If the
such sums as may be necessary for FY2011-FY2014. In addition,
Secretary issues a written export certification, a fee may be
the Secretary is required to increase the field staff of these three
charged.
entities with a goal of not fewer than: (1) 4,000 staff members in
Obama Administration: In addition to requesting increased
FY2011; (2) 4,200 staff members in FY2012; (3) 4,600 staff
funds for FY2010 (see above), the Administration has endorsed
members in FY2013; and (4) 5,000 staff members in FY2014.
the registration, reinspection, and export certification fees in §§
Within the total, field staff for food defense activities and for
101, 108, and 203 of the House bill.
smuggled food detection and removal shal be increased by 150
employees by FY2011.
Food Safety Research
Research (§ 123)
Food Safety Integrated Centers of Excellence (§ 210)
FDA, along with other federal agencies, is already involved in a
Requires the Secretary to conduct research to assist in
Section 210(b) of this section, regarding Food Safety Integrated
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variety of research activities, in such areas as how and where
implementation of the act, including studies to improve
Centers of Excellence, which would, among other things,
food contamination occurs, biotechnology and al ergenicity
sanitation and food safety practices in food production,
conduct food safety research. Requires the Secretary and the
issues, seafood safety, color additives, consumer studies, the
harvesting, processing, develop improved monitoring and food
CDC Director (in consultation with other groups) to designate
detection, characterization, and behavior of foodborne
inspection techniques, develop efficient and rapid methods for
five “Integrated Food Safety Centers of Excellence” at selected
pathogens, for example. Collaborative research efforts have
detecting the presence of food contaminants, among other
state health departments to serve as resources for federal, state,
been underway for some time with USDA’s Agricultural
specific areas of emphasis.
and local public health professionals. Authorizes the
Research Service and Cooperative State Research, Education,
appropriation of such sums as necessary to carry out this
and Extension Service, and with academia, state health and
provision.
agricultural officials, industry and others. The Administration’s
FY2010 budget proposal anticipates research in high priority
areas such as reducing risk of E. coli in produce, speeding
response to outbreaks through improved testing and other new
technologies, limiting the adverse health effects of both
intentional and unintentional food contamination, and upgraded
information technology systems.
Bisphenol A (BPA)
Bisphenol A in Food and Beverage Containers (§ 215)
No comparable provision.
Bisphenol A (BPA) is used to produce certain types of plastic,
Requires the Secretary to notify Congress by December 31,
including food containers. In the United States and elsewhere,
2009 on whether available scientific data support “a
scientific disagreement about the possibility of human health
determination that there is a reasonable certainty of no harm,
effects that may result from BPA exposure through food and
for infants, young children, pregnant women, and adults, for
water has led to conflicting regulatory decisions regarding the
approved uses” of plastics made with BPA in food and beverage
safety of food containers, especial y those intended for use by
containers. If such a determination cannot be made for any use,
infants and children.
the Secretary must inform Congress on what actions will be
taken to protect public health.
BPA-containing PC polymers and epoxy resins used in food
containers—such as baby bottles and infant formula cans,
respectively—are regulated by FDA as food contact substances.
Applicable FDA regulations are at 21 CFR §§ 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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S. 510 (Manager’s Amendment)
Requirements for Infant Formula
Infant Formula (§ 114)
No comparable provision.
FFDCA § 412 sets forth detailed requirements whereby
Alters several requirements which apply to a manufacturer of a
manufacturers of infant formula are required to provide FDA
new infant formula; e.g., FDA would have additional time to
with assurances of the nutritional quality of their formulations
review certain safety information regarding new ingredients.
before marketing the formula. FDA has requirements for certain
labeling, nutrient content, quality control procedures, and
company recordkeeping and 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.
Additive and Labeling Requirements
Food Substances Generally Recognized As Safe (§ 201)
No comparable provision.
This issue revolves around FDA’s exercise of so-called
Requires the Secretary to publish within 60 days on the FDA
“generally recognized as safe” (GRAS) determinations. Under
public website, notice of receipt of a request for a substance to
current law, substances which FDA agrees are GRAS are
be determined by the Secretary to be General y Recognized As
exempt from the much more rigorous premarket approval
Safe (GRAS), and supporting scientific justifications, among other
process required for other food additives. Under a 1997
provisions. This section does not appear to address the GRAS
proposed rule, FDA proposed creating a notification procedure
notification procedure, as it discusses requests for substances to
for GRAS substances through which manufacturers can notify
be determined by the Secretary to be GRAS. In the notification
the FDA of their “determination that a particular use of a
procedure, the manufacturer or other individual makes the
substance is GRAS,” thereby bypassing the regular federal
conclusion that the substance is GRAS and the FDA states that
rulemaking procedures. In fact, FDA has been using this GRAS
it has “no questions” about this conclusion, that the notice does
notification procedure since the publication of the proposed rule not provide a basis for a GRAS status determination, or that the
on an “interim policy” basis.
individual has stopped the GRAS notification process.
Lead in Ceramics
Lead Content Labeling Requirement for Ceramic
No comparable provision.
Tableware and Cookware (§ 216)
Pursuant to its FFDCA authority, FDA regulates food contact
surfaces as well as food. The FDA has standards regarding the
Would deem ceramic tableware and cookware misbranded
leaching of lead from ceramics that are to be used for food.
under the FFDCA if it includes a glaze or decorations containing
These are at “Compliance Policy Guide (CPG) Sec. 545.450
lead for an intended functional purpose, unless either: it and its
Pottery (Ceramics); Import and Domestic—Lead
package bears statement: “This product is made with lead-based
Contamination” (CPG 7117.07).
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.
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S. 510 (Manager’s Amendment)
Sanitary Transportation of Food
No comparable provision.
Sanitary Transportation of Food (§ 111)
FFDCA § 416, regarding sanitary transportation practices for
Requires the Secretary, within one year of enactment, to
food, was established in § 7202 of the Safe, Accountable,
promulgate regulations described in FFDCA § 416(b), which say,
Flexible, Efficient Transportation Equity Act: A Legacy for Users
“The Secretary shal by regulation require shippers, carriers by
(SAFETEA-LU), P.L. 109-59, August, 2005. The law requires the
motor vehicle or rail vehicle, receivers, and other persons
Secretary to promulgate applicable regulations, but does not
engaged in the transportation of food to use sanitary
state a deadline for doing so.
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 Allergies
No comparable provision.
Food Allergy and Anaphylaxis Management (§ 112)
FFDCA § 403(w) requires food products that contain any of the
Requires the Secretary, within one year of enactment and in
eight most common food allergens (defined in FFDCA §
consultation with the Secretary of Education, to develop, and
201(qq)) to declare their presence on the food label.
make available to local educational agencies (LEAs), guidelines to
Noncompliant food is deemed misbranded. This requirement
develop plans for individuals to manage the risk of food allergy
was established by the Food Allergen Labeling and Consumer
and anaphylaxis in schools and early childhood education
Protection Act of 2004 (P.L. 108-282). The act focused
programs. The voluntary guidelines shall address specified
specifically on food labeling and did not address food allergy and
elements, as follows: (1) parental obligation to provide the
anaphylaxis (a severe, whole-body al ergic reaction) management
school with information regarding a student’s food allergy and
in schools or elsewhere. FDA has announced it is developing a
risk of anaphylaxis; (2) an individual plan created with the parent
long-term strategy to assist manufacturers to better inform food
and tailored to each student with a documented risk for
allergic consumers about the allergens in their products.
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 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 shal 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
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S. 510 (Manager’s Amendment)
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 shal 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.
Vitamins and Minerals, Anabolic Steroids
No comparable provision.
New Dietary Ingredients (§ 113)
FFDCA section 413 [21 U.S.C. 350b] requires that
Amends 21 U.S.C. 350b. Requires the Secretary to notify the
manufacturers and distributors of dietary supplements who wish
U.S. Drug Enforcement Agency, as specified, if s/he determines
to market dietary supplements that contain “new dietary
that the information in a new dietary ingredient notification
ingredients" (those not marketed in the United States in a
submitted under this section for an article purported to be a
dietary supplement before October 15, 1994) notify FDA about
new dietary ingredient is inadequate to establish that a dietary
these ingredients.
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.
Source: Prepared by CRS.
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Author Contact Information
Renée Johnson
Specialist in Agricultural Policy
rjohnson@crs.loc.gov, 7-9588
Acknowledgments
This report was originally written by Geoffrey S. Becker, Specialist in Agricultural Policy.
Congressional Research Service
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