Food Safety in the 111th Congress: H.R. 2749
and S. 510

Renée Johnson
Specialist in Agricultural Policy
Sarah A. Lister
Specialist in Public Health and Epidemiology
Erin D. Williams
Specialist in Public Health and Bioethics
Vanessa K. Burrows
Legislative Attorney
November 16, 2010
Congressional Research Service
7-5700
www.crs.gov
R40443
CRS Report for Congress
P
repared for Members and Committees of Congress

Food Safety in the 111th Congress: H.R. 2749 and S. 510

Summary
American consumers spend more than $1 trillion on food each year. The combined efforts of the
food industry and government regulatory agencies often are credited with making the U.S. food
supply among the safest in the world. Nonetheless, public health officials have estimated that
each year in the United States, many millions of people become sick, and thousands die from
foodborne illnesses caused by any one of a number of microbial pathogens and other
contaminants. At issue is whether food safety agencies have the resources, authority, and
structural organization to safeguard the public, and whether they use resources effectively. Also at
issue is whether federal food safety laws, first enacted in the early 1900s, have kept pace with the
significant changes in the food production, processing, and marketing sectors since then.
In the 111th Congress, several food safety bills have been introduced, and comprehensive
legislation (H.R. 2749) has passed the House. The Senate also has reported a comprehensive bill
(S. 510). Both bills mainly focus on the U.S. Food and Drug Administration’s (FDA’s) food
regulation rather than that of the U.S. Department of Agriculture (USDA), which oversees most
meat and poultry. The bills would generally expand or modify existing FDA authorities rather
than create a new food safety structure or authorities. 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 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 (the “Senate amendment”). Senate floor action has been held up by
objections about the projected cost of the proposal, 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 infrequently
visits food manufacturing and other facilities to check sanitary and other conditions. The
proposed bills would require (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............................................................................................................ 2
Existing Food Safety Legal and Regulatory Landscape.......................................................... 3
Administration Views............................................................................................................ 5
Congressional Response........................................................................................................ 6
Legislative Overview ...................................................................................................... 7
Overview of Major Provisions......................................................................................... 8
Selected Issues .......................................................................................................................... 11
Registration ........................................................................................................................ 11
Recordkeeping .................................................................................................................... 12
Hazard Analysis and Risk-Based Preventive Controls.......................................................... 13
Performance Standards........................................................................................................ 15
On-Farm Safety Standards; Safety of Produce ..................................................................... 16
Mitigating Effects on Small Business and Farming Operations ............................................ 18
Targeting of Inspections ...................................................................................................... 25
Use of Third Parties for Imports and for Laboratory Accreditation....................................... 28
Mandatory Recall Authority ................................................................................................ 30
Notification of Contaminated Products and Product Tracing................................................ 31
Foodborne Illness Surveillance and Outbreak Response ...................................................... 33
Criminal Penalties............................................................................................................... 35
Food Imports ...................................................................................................................... 38
Bisphenol A (BPA).............................................................................................................. 40
Paying for Food Safety with User Fees................................................................................ 41

Tables
Table 1. Crosswalk of Provisions in House-passed H.R. 2749 and the S. 510 Amendment
According to Topic................................................................................................................. 10
Table 2. U.S. Farms and Food Manufacturers, 2007................................................................... 20
Table 3. FDA Food-Related Inspection Data, FY2004-FY2011.................................................. 25
Table 4. Criminal Penalties for Violations of FFDCA § 303(a)................................................... 36
Table 5. FDA Direct Appropriations for Foods, FY2005-FY2011 .............................................. 42
Table 6. Types of Fees in House-Passed H.R. 2749 and Senate Manager’s Amendment to
S. 510 .................................................................................................................................... 44
Table 7. Comparison of Annual Fees in House-Passed H.R. 2749 and Senate Manager’s
Amendment to S. 510............................................................................................................. 46
Table 8. Comparison of Periodic Fees in House-Passed H.R. 2749 and Senate Manager’s
Amendment to S. 510............................................................................................................. 47

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Food Safety in the 111th Congress: H.R. 2749 and S. 510

Appendixes
Appendix A. Snapshot of Provisions According to Sections of House-passed H.R. 2749
and the S. 510 Amendment (ranked by section number).......................................................... 49
Appendix B. Comparison of Current Law with Provisions in House-passed H.R. 2749
and the S. 510 Amendment..................................................................................................... 52

Contacts
Author Contact Information ...................................................................................................... 98
Acknowledgments .................................................................................................................... 98

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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
This CRS report discusses several recent food safety incidents and the systemic food safety
problems that they illustrated; describes the existing food safety legal and regulatory landscape;
and presents an overview of efforts by the 111th Congress to revise federal food safety authorities
and activities, principally at FDA. The key measures discussed are H.R. 2749, the Food Safety
Enhancement Act of 2009, which has passed in the House, and S. 510, the FDA Food Safety
Modernization Act, which has been reported in the Senate. Next, this report presents a number of
selected food safety issues, describing how they are addressed in current law and regulation, and
comparing their treatment in each of the key bills. Finally, appendixes provide a crosswalk of all
provisions in H.R. 2749 and S. 510, followed by a side-by-side comparison of all of these
provisions with each other and with current law.

1 According to the U.S. Department of Health and Human Services, Centers for Disease Control and Prevention, 76
million people become sick, 325,000 are hospitalized, and 5,000 die from foodborne illnesses each year (“Foodborne
Illness: Frequently Asked Questions,” accessed at http://www.cdc.gov/foodsafety/). However, this estimate appears to
be based primarily on 1997 and earlier data in a report by Paul S. Mead et al., “Food-related Illness and Death in the
United States,” Emerging Infectious Diseases, vol. 5, pp. 607-625, 1999.
2 Nearly half of U.S. food spending is now in restaurants and other places outside the home. Roughly two-thirds of the
$1 trillion is for domestically produced farm foods; imports and seafood account for the balance. Data source: U.S.
Department of Agriculture (USDA), Economic Research Service.
3 GAO, High Risk Series: An Update (GAO-09-271), January 2009.
4 Source: USDA and HHS budget materials for FY2011. The FDA figure does not include some food safety activities
carried out by the Center for Veterinary Medicine and National Center for Toxicological Research. For more
information on current food safety authorities and agencies, with sources, see CRS Report RS22600, The Federal Food
Safety System: A Primer
. Also see CRS Report R40721, Agriculture and Related Agencies: FY2010 Appropriations.
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Food Safety Incidents5
Food safety-related incidents frequently heighten public and media scrutiny of the U.S. food
safety system.6 Large recalls of FSIS-regulated meat and poultry products due to findings of E.
coli
O157:H7, Listeria, and other problems occur each year.7 In addition, in recent years, several
large multi-state outbreaks have been linked to FDA-regulated foods. For example, in 2006 more
than 200 confirmed illnesses and three deaths were linked to bagged fresh spinach grown in
California and contaminated with E. coli O157:H7. In 2008, more than 1,400 persons were
infected with the same unusual strain of bacteria, Salmonella Saintpaul. Officials first suspected
fresh tomatoes, but later tests found the pathogen in serrano peppers and irrigation water from a
farm in Mexico. These incidents raised public concerns about the safety of all fresh produce and
stimulated a number of industry and government initiatives to limit future incidents.
Attention focused on the safety of food imports in 2007, when pet food ingredients imported from
China, contaminated with the chemical melamine, sickened or killed an unknown number of dogs
and cats and contaminated some livestock feeds. In 2008, melamine contamination of infant
formula in China sickened thousands of children and raised concerns about the safety of infant
formula in the United States. The melamine incidents highlighted the limited reach of FDA’s
oversight of imports, the difficulty in tracing the many pathways taken by a common food
ingredient, and the frequent confluence of human and animal food ingredients.
In late 2008 and early 2009, a multi-state outbreak of Salmonella Typhimurium was linked to an
institutional brand of peanut butter and other peanut-based ingredients from a single firm. The
outbreak sickened more than 700 people in 46 states, and may have contributed to the deaths of
nine people. A series of expanding recalls was announced by FDA in early 2009, involving
thousands of peanut-containing products from more than 200 companies. Again, the incident
highlighted the broad reach of a common contaminated ingredient, and the resultant challenges in
rapidly tracing products and removing them from commerce.
In July 2010, health officials noticed a spike in cases of infection with Salmonella Enteritidis, a
strain commonly associated with shell eggs, which are regulated by FDA.8 In August, FDA found
the same pathogen on two egg farms in Iowa, leading to the nationwide recall by the companies
of more than 500 million eggs.9 In July 2009, FDA had published a long-awaited egg safety
regulation, which became effective in July 2010 as the outbreak was well underway.10 Although
most observers believe that the rule, if enforced, will help to prevent shell egg contamination and
outbreaks in the future, many remain concerned with the apparent lack of coordination between
USDA’s egg quality inspection activities and FDA’s food safety activities.11

5 Unless otherwise cited, material in this paragraph is adapted from CRS Report R40916, Food Safety: Foodborne
Illness and Selected Recalls of FDA-Regulated Foods
.
6 Three recent multi-state foodborne outbreaks and their implications for the nation’s food safety system are discussed
in more depth in CRS Report R40916, Food Safety: Foodborne Illness and Selected Recalls of FDA-Regulated Foods.
7 For information on meat and poultry recalls, see the FSIS website: http://www.fsis.usda.gov/fsis_recalls/index.asp.
8 USDA regulates processed egg products, and grades shell eggs for quality (such as grade and size), but does not
oversee the safety of shell eggs.
9 FDA, “Salmonella Enteritidis Outbreak in Shell Eggs,” http://www.fda.gov/Food/NewsEvents/WhatsNewinFood/
ucm222684.htm.
10 FDA, “Prevention of Salmonella Enteritidis in Shell Eggs During Production, Storage, and Transportation; Final
Rule,” 74 Federal Register 33029, July 9, 2009. See also FDA, “Egg Safety Final Rule,” http://www.fda.gov/Food/
FoodSafety/Product-SpecificInformation/EggSafety/EggSafetyActionPlan/ucm170615.htm.
11 Alicia Mundy, Bill Tomson, “Egg Inspectors Failed to Raise Alarms,” The Wall Street Journal, September 10, 2010.
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Existing Food Safety Legal and Regulatory Landscape
Federal responsibility for food safety rests primarily with FDA and USDA.12 FDA is responsible
for ensuring that all domestic and imported food products—except for most meats and poultry—
are safe, nutritious, wholesome, and accurately labeled. FDA also has oversight of all seafood,
fish, and shellfish products. USDA’s FSIS regulates most meat and poultry and some egg
products. State and local food safety authorities collaborate with federal agencies for inspection
and other food safety functions, and they regulate retail food establishments.
The division of food safety responsibility between FDA and USDA is rooted in the early history
of U.S. food regulation. Congress created separate statutory frameworks when it enacted, in 1906,
both the Pure Food and Drugs Act and the Meat Inspection Act. The former addressed the
widespread marketing of intentionally adulterated foods, and its implementation was assigned to
USDA’s Bureau of Chemistry. The latter law addressed unsafe and unsanitary conditions in meat
packing plants, and implementation was assigned to the USDA’s Bureau of Animal Industry. This
bifurcated system has been perpetuated and split further into additional food safety activities
under additional agencies (for example, the Environmental Protection Agency, the National
Marine Fisheries Service, and others) by a succession of statutes and executive directives. The
separation of the two major food safety agencies was further reinforced when, in 1940, the
President moved responsibilities for safe foods and drugs, other than meat and poultry, from
USDA to the progenitor of HHS, the Federal Security Agency. Meat inspection remained in
USDA. There has been discussion over time regarding whether this dispersal of food safety
responsibilities has been problematic, or whether a reorganization would divert time and attention
from other fundamental problems in the system.13
Major food safety bills under consideration in the House and Senate (H.R. 2749 and S. 510,
which are the subject of this report) do not propose a major reorganization of food safety
agencies. Rather, they focus on changes related to FDA, not USDA. The primary law authorizing
FDA activities is the Federal Food, Drug, and Cosmetic Act (FFDCA; 21 U.S.C. §§ 301 et seq.).
Some key FFDCA provisions that are discussed throughout this report are presented in the text
box on the next page.
Two of the basic statutory components from the FFDCA are “adulteration” and “misbranding.”
FDA-regulated foods may be deemed adulterated or misbranded for a variety of statutorily
prescribed reasons. For example, food may be deemed adulterated if it contains an added
poisonous or deleterious substance or an unsafe food additive or if the food was prepared, packed,
or held under insanitary conditions whereby it may have become contaminated or may have been
rendered injurious to health. Persons who violate the FFDCA by, for example, introducing an
adulterated or misbranded product into interstate commerce, commit what is referred to as a
prohibited act under FFDCA § 301 (21 U.S.C. § 331). Persons who commit prohibited acts are
subject to criminal and civil penalties.

12 For further background information about the food safety system, see CRS Report RS22600, The Federal Food
Safety System: A Primer
. For further information about FDA’s regulatory authority, see CRS Report RS22946, Food
and Drug Administration (FDA): Overview and Issues
.
13 For a discussion of the history of federal food safety organization and of efforts to change it, see Merrill, Richard A.
and Jeffrey K. Francer, “Organizing Federal Food Safety Regulation,” Seton Hall Law Review, vol. 31:61, 2000. See
also GAO, High Risk Series: An Update (GAO-07-310), January 31, 2007; and Ensuring Safe Food From Production
to Consumption
, Committee to Ensure Safe Food from Production to Consumption, Institute of Medicine, National
Research Council, National Academy Press, 1998.
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Key Definitions and Authorities in the Federal Food, Drug, and Cosmetic Act (FFDCA)
Food: FFDCA § 201(f) [21 U.S.C. § 321(f)] defines food as “(1) articles used for food or drink for man or other animals, (2) chewing
gum, and (3) articles used for components of any such article.” Unless a provision in law regarding food limits its applicability to one or
the other, it would apply equal y to both human foods, and to animal foods and feeds.
Raw Agricultural Commodity: FFDCA § 201(r) [21 U.S.C. § 321(r)] defines the term “raw agricultural commodity” to mean
any food in its raw or natural state, including all fruits that are washed, colored, or otherwise treated in their unpeeled natural form prior to
marketing.” This may also refer to an unprocessed human food or animal feed crop, including fresh fruits and vegetables, grains, or
other crops and products.
Adulteration: Under the FFDCA, introducing adulterated food into commerce, adulterating food that is in commerce, or the
receipt and delivery of adulterated food in commerce, is prohibited (FFDCA § 402(a) [21 U.S.C. § 342(a)]):
A food shall be deemed to be adulterated—
(1) If it bears or contains any poisonous or deleterious substance which may render it injurious to health; but in case the substance is not an

added substance such food 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, introducing misbranded food into commerce, misbranding food that is in commerce, or the
receipt and delivery of misbranded food in commerce is prohibited. (See “Prohibited Acts” below.) FFDCA § 403 [21 U.S.C. §
343] defines a number of conditions under which a food would be deemed to be misbranded, beginning with a broad provision in
paragraph (a) saying that a food is deemed misbranded if its label “is false or misleading in any particular,...” Similar to the definition
of adulteration, numerous specific types of misbranding are also defined. These include, among others, failure to disclose specific
additives or allergens in the food, and failure to provide required nutritional information.
Person: FFDCA § 201(e) [21 U.S.C. § 321(e)] defines “person” to include an individual, partnership, corporation, and association.
In this report, for simplicity, “facility” is often used to refer to actions that may or must be taken with respect to a facility, though
it is, of course, a person, typically the owner, operator or agent in charge of the facility, who may or must act.
Facility: FFDCA § 415(b) [21 U.S.C. § 350d(b)] defines a food facility as “any factory, warehouse, or establishment (including a factory,
warehouse, or establishment of an importer) that manufactures, processes, packs, or holds food. Such term does not include farms;
restaurants; other retail food establishments; nonprofit food establishments in which food is prepared for or served directly to the consumer;
or fishing vessels (except such vessels engaged in processing as defined in [21 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 introducing adulterated or misbranded food into commerce; adulterating
or misbranding food that is in commerce; or the receipt and delivery of adulterated or misbranded food in commerce, is
prohibited. Pursuant to FFDCA § 303 [21 U.S.C. § 333], in general, any person who violates a provision of FFDCA § 301 may be
subject to civil or criminal penalties, including imprisonment, fines, or both. Criminal penalties provided for in the FFDCA are
adjusted by 18 U.S.C. §§ 3559 and 3571. Certain exceptions may be made, including for the misbranding of foods.
Source: Prepared by CRS based on the FFDCA. A version of the FFDCA is available on FDA’s website at http://www.fda.gov/
RegulatoryInformation/Legislation/FederalFoodDrugandCosmeticActFDCAct/default.htm. It does not reflect two recent laws. P.L.
111-31, the Family Smoking Prevention and Tobacco Control Act, redesignated Chapter IX (miscel aneous provisions) as Chapter
X, and inserted tobacco control provisions in Chapter IX. P.L. 111-148, the Patient Protection and Affordable Care Act, amended
several FFDCA sections and added a new § 1011, establishing an FDA Office of Women’s Health.
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Administration Views
The George W. Bush Administration issued several reports and studies calling for major changes
in the food safety system. Two Bush Administration initiatives were unveiled in November 2007
and were critiqued and debated extensively during the 110th Congress. They were the FDA’s Food
Protection Plan: An Integrated Strategy for Protecting the Nation’s Food Supply
, and the
Interagency Working Group on Import Safety’s Action Plan for Import Safety: A Roadmap for
Continual Improvement
, part of which dealt extensively with food product imports.14 Both reports
generally called for a more preventive risk-based approach to food safety oversight, including
more attention to imported foods, among numerous other recommendations.
President Barack Obama, in a March 14, 2009, weekly radio address, called the food safety
system a “hazard to public health.”15 He announced a Food Safety Working Group (FSWG) of
Cabinet secretaries and senior officials “to advise me on how we can upgrade our food safety
laws for the 21st century; foster coordination throughout government; and ensure that we are not
just designing laws that will keep the American people safe, but enforcing them.”16 In July 2009,
the FSWG announced a number of steps the Obama Administration was taking, under existing
authorities, to improve government safeguards.17 The group released a one-year progress report in
July 2010.18 Also, the Administration announced that it had “taken steps to reduce the prevalence
of E. coli, implemented new standards to reduce exposure to Campylobacter, and issued a rule to
control Salmonella contamination,” and that “FDA has conducted a pilot study on a tracing
system, and HHS, in collaboration with USDA, has rolled out an enhanced and updated
www.foodsafety.gov site to provide consumers rapid access to information on food recalls.”19
The Obama Administration has weighed in on the principal bills that have been considered by the
House and Senate during the 111th Congress (and that are the subject of this report). The
Administration declared its support for H.R. 2749, which has passed in the House.20 Also, in a
July 2010 statement, the Administration further urged the Senate to complete its work on S. 510.21
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

14 FDA, “An Integrated Strategy for Protecting the Nation’s Food Supply,” November 2007, http://www.fda.gov/Food/
FoodSafety/FoodSafetyPrograms/FoodProtectionPlan2007/ucm132565.htm; and the Interagency Working Group on
Import Safety, “Action Plan for Import Safety: A Roadmap for Continual Improvement,” November 2007,
http://archive.hhs.gov/importsafety/report/actionplan.pdf.
15 The White House, Remarks of President Barack Obama, “Reversing a Troubling Trend in Food Safety,” weekly
address, Washington, DC, March 14, 2009, http://www.whitehouse.gov/briefing-room/weekly-address.
16 The working group established a public website at http://foodsafetyworkinggroup.gov/, where the full text of these
remarks may be viewed.
17 FSWG, “Food Safety Working Group: Key Findings,” July 7, 2009, http://www.foodsafetyworkinggroup.gov/.
18 FSWG, “Food Safety Working Group: Progress at 1 Year,” July 9, 2010, http://www.foodsafetyworkinggroup.gov/.
19 The White House, Statement by the President on Food Safety, July 7, 2010, http://www.whitehouse.gov/the-press-
office/statement-president-food-safety.
20 The White House, Statement by the President on House Passage of the Food Safety Enhancement Act of 2009, July
30, 2009, http://www.whitehouse.gov/the-press-office/statement-president-house-passage-food-safety-enhancement-
act-2009.
21 The White House, Statement by the President on Food Safety, July 7, 2010, http://www.whitehouse.gov/the-press-
office/statement-president-food-safety.
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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, 2009.22
In October 2009 testimony on the Senate bill, FDA Commissioner Hamburg called S. 510 a
“major step in the right direction.” Provisions in the bill address a key policy concern by
refocusing FDA’s food safety system on prevention, the Commissioner stated. She added that the
bill also generally meets another key policy concern, the need for adequate FDA legal tools to
implement the new requirements, although some additional provisions, such as effective
enforcement mechanisms, should be added. Finally, the Commissioner stated, the legislation must
provide or anticipate adequate resources, but it “does not provide a guaranteed consistent funding
source to help FDA fulfill its new responsibilities.” The Commissioner recommended the
inclusion of registration fees, flexibility to adjust facility inspection frequencies, and use of
accredited third parties to ensure adequate resources.23 (These issues are among those discussed
later in this report.)
Congressional Response
These and other developments have made food safety a top issue for many lawmakers. Some
Members of Congress have called for major changes in the U.S. food safety system and/or
funding increases that they assert are needed to meet current obligations to protect consumers
from unsafe food. Perceived gaps in federal safeguards have been explored at more than two
dozen congressional hearings since 2007.24 The 110th Congress made several amendments to
FDA’s food safety authorities,25 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.

22 Dr. Hamburg’s comments were based on the introduced version of H.R. 2749; Mr. Taylor’s were based on the
version reported by the full Energy and Commerce Committee (H.Rept. 111-234) in June 2009.
23 Statement of FDA Commissioner Margaret Hamburg, U.S. Congress, Senate Committee on Health, Education,
Labor, and Pensions, Keeping America’s Families Safe: Reforming the Food Safety System, 111th Cong., 1st sess.,
October 22, 2009, http://help.senate.gov/hearings/index.cfm.
24 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.
25 CRS Report RS22779, Food Safety: Provisions in the Food and Drug Administration Amendments Act of 2007.
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Legislative Overview
In the 111th Congress, nearly a dozen food safety bills, several of them comprehensive, have been
introduced. However, the major vehicle in the House is H.R. 2749, introduced by Representative
John Dingell. This bill was amended and approved by the Subcommittee on Health of the House
Energy and Commerce Committee on June 10, 2009; and by the full committee on June 17, 2009
(H.Rept. 111-234, July 29, 2009). After failing to reach the needed two-thirds majority under
suspension of the rules on July 29, 2009, the bill passed the House under regular order, with a
recorded vote of 283 to 142, on July 30, 2009.26
In the Senate, the major vehicle is S. 510, introduced by Senator Richard Durbin. The HELP
Committee amended and approved the bill on November 18, 2009, and reported it (without a
written report) on December 18, 2009.
During the spring and summer of 2010, Senators discussed potential amendments to S. 510,
aimed at addressing issues of continued interest. On August 12, 2010, several members of the
HELP Committee, including Chairman Senator Tom Harkin and Ranking Member Senator Mike
Enzi, along with Senator Durbin, released a “manager’s package,” an amendment to S. 510 in the
nature of a substitute.27 Following the release of the proposed amendment, Senate floor action
was widely anticipated. However, as of September 2010, further action on the measure had
stalled. Among other things, Senator Tom Coburn objected to the projected cost of the measure.28
Several proposals under consideration in the Senate were not included in the Senate manager’s
proposal (referred to as the “Senate amendment” in this report). These include (1) a proposal by
Senator Dianne Feinstein to phase out the use of bisphenol-A (BPA) in food packaging;29 (2) 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 certain
qualified end-users;30 and (3) S. 3767, a bill introduced by Senator Patrick Leahy that would
increase criminal penalties for persons who knowingly distribute contaminated food products.31
(These three proposals are discussed in more detail in the following sections of this report,
respectively: “Bisphenol A (BPA),” “Mitigating Effects on Small Business and Farming
Operations,” and “Criminal Penalties.”)

26 Two other comprehensive House bills that have been introduced are H.R. 875 by Representative Rosa DeLauro, a
blueprint for a new, independent Food Safety Administration (FSA), separate from the current FDA but still within
HHS, which would 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 Jim Costa, which is similar in design to the
version of the Senate bill originally introduced by Senator Richard Durbin (S. 510).
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.
29 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.
30 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
.
31 S. 3767 was reported by the Senate Judiciary Committee (without written report) on September 23, 2010.
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On September 29, 2010, Senator Harry Reid filed a cloture motion to allow consideration of S.
510.32 It is widely reported that a vote on the motion may be held on November 17, 2010.33 Under
an earlier failed unanimous consent request, Senator Durbin had called for six specified
amendments to be in order: a Harkin-Enzi substitute amendment; a Harkin-Enzi technical
amendment; a Tester amendment regarding small farms and facilities; a Coburn amendment in
reference to offset for the cost of the bill; a Feinstein amendment in reference to BPA; and a
Leahy amendment in reference to criminal penalties.34 The fate of these amendments under the
cloture motion has yet to be announced.
Overview of Major Provisions
Both the House-passed bill and the Senate amendment 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 measures seek to address many of the same
perceived problems with the current food safety system. For example, a growing consensus
among industry and consumer groups is that the FDA’s current programs are not proactively
designed to emphasize prevention, evaluate hazards, and focus inspection resources on areas of
greatest risk to public health.35 Rather, FDA generally has been reactive, usually stepping in when
adulterated or misbranded products are found in commerce or an illness outbreak leads them to a
problem. Given FDA’s funding and staffing constraints, and no explicit requirement for the
frequency of inspections, the agency infrequently visits food manufacturing and other facilities to
check sanitary and other conditions.36
Both the House and Senate measures would require (although in different ways) food processing,
manufacturing, shipping, and other regulated facilities to conduct an analysis of the most likely
food safety hazards and to design and implement risk-based controls to prevent them. These
proposals are similar conceptually to the so-called hazard analysis and critical control point, or
HACCP, plans required of meat and poultry establishments. The measures envision the
establishment of science-based “performance standards” for the most significant food
contaminants. To aid in determining such risks and hazards, both bills propose the improvement
of foodborne illness surveillance systems aimed at better data reporting, analysis, and usefulness,
with the CDC playing a lead role.
Both the House-passed bill and the Senate amendment seek to increase the frequency of plant
inspections, taking into account the risks posed by specific foods or processes. To aid in such
inspections, and to improve the ability to rapidly trace food products through the production and

32 Senator Harry Reid, FDA Food Safety Modernization Act, Motion to Proceed, Congressional Record, daily edition,
vol. 156 (September 29, 2010), p. S7730.
33 See the calendar of the Senate Democratic caucus, http://democrats.senate.gov/calendar/2010-11.html.
34 Senator Richard Durbin, Unanimous Consent Request - S. 510, Congressional Record, daily edition, vol. 156
(September 23, 2010), p. S7394. See also footnote 28.
35 See, for example, Jerry Hagstrom, “Array of Groups Push Senate Action on Food Safety Bill,” CongressDailyAM,
September 21, 2010.
36 See, for example, FDA, “Strategic Priorities 2011–2015: Responding to the Public Health Challenges of the 21st
Century,” draft, September 29, 2010, pp. 14-15, http://www.fda.gov/AboutFDA/ReportsManualsForms/
Reports/ucm227527.htm.
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marketing chain in the event of a foodborne illness outbreak, suspected contamination, or other
problems, the bills generally seek to strengthen record-keeping requirements and food traceability
systems. Industry participants would be required to maintain records for certain time periods and
in formats to be prescribed by FDA. The importance of adequate records has been demonstrated
in recent food safety incidents, particularly in the case of outbreaks eventually linked to fresh
produce. Food establishments, which are already subject to a one-time registration requirement
under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (P.L.
107-188; 21 U.S.C. § 350d), would have to re-register more frequently under the bills, which ask
for additional registration information. Also, the House-passed bill would require a $500-per-
facility annual registration fee.
The measures also appear to agree on the need to give FDA the authority to mandate product
recalls if a firm with suspect products fails to do so voluntarily. Currently FDA lacks such
authority for food, except for infant formula. However, the measures differ somewhat on how
such authority might be applied, and on related requirements for notification when adulterated or
misbranded food threatens public health.
Both measures 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-passed bill and Senate
amendment differ in detail on how to accomplish these objectives. They also address the need for
certifying or accrediting laboratories, including private laboratories, to conduct sampling and
testing of food.
Provisions in the measures 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 measures is how the proposed program changes would be funded.
Specifically, the House-passed bill would institute a new $500 annual facility registration fee that
would help offset the cost of various FDA activities in the bill; a similar annual facility fee is not
included in the Senate amendment, and other fees included in the Senate measure are not
expected to raise as much revenue. The Congressional Budget Office (CBO) estimates that
implementing H.R. 2749 (as reported by the Energy and Commerce Committee) would increase
net federal spending subject to appropriation by about $2.0 billion over a five-year period
(FY2010-FY2014); federal revenues from civil penalties for food-related violations under the
FFDCA would increase by $10 million over the same period.37 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.”38 Despite higher offsetting

37 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.
38 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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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.
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.
Table 1 provides a crosswalk of topics covered in this report and corresponding section numbers
from the two major proposals. This table does not contain all of the topics or sections contained in
the two proposals, only those included in the body of this report.
Table 1. Crosswalk of Provisions in House-passed H.R. 2749 and the S. 510
Amendment According to Topic
Topic
H.R. 2794 (House-passed)
S. 510 (Amendment)
Registration 53
53
Recordkeeping 61
61
Hazard Analysis and Risk-Based
54 54,
92
Preventive Controls
Performance Standards
56
56
On-Farm Safety Standards; Safety
57 57
of Produce
Mitigating Effects on Small
53, 54, 57, 61, 62, 72
61, 53, 54, 57, 59, 62
Business and Farming Operations

59, 81
59, 81
Targeting of Inspections
Use of Third Parties for Imports
94, 69
69, 94
and for Laboratory Accreditation
Mandatory Recal Authority
54, 59, 64, 70, 80
70
Notification of Contaminated
62, 72
62, 72
Products and Product Tracing
Foodborne Illness Surveillance and
75 75
Outbreak Response
Criminal Penalties
77
77
Food Imports
66, 73, 78, 80
80, 73, 94
Bisphenol A (BPA)
87
87
Paying for Food Safety with User
53, 64
64
Fees
Source: Prepared by CRS staff based on the text of H.R. 2749 (House-passed), S. 510 (Amendment), and
publicly available amendments that may be offered to S. 510.
Note: Terms in the Topic column are hyperlinked to corresponding sections in this report. Section numbers in
the H.R. 2794 and S. 510 columns are hyperlinked to corresponding sections in the side-by-side comparison of
current law and the two proposals are contained in the tables at the end of this report (Appendix A and
Appendix B).
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For a comprehensive listing of all sections and topics addressed in the two proposals, see the two
appendix tables at the end of this report. The first table, Appendix A, provides a snapshot of each
section and topic covered by the proposals. It is arranged numerically by section of H.R. 2749,
and then by those remaining sections of S. 510 with no corollary. The second table, Appendix B,
is arranged in the same order and contains a side-by-side comparison of current law with
provisions in the two proposals.
Each topic in Appendix A is hyperlinked to the corresponding topic in Appendix B, so that the
former can be used as a table of contents for the latter. Topics in Appendix B are hyperlinked to
corresponding sections of this report where they exist, so that readers can easily move from the
side-by-side to related policy context and analysis.
In the “Selected Issues” section that follows, section numbers of the House-passed bill and Senate
amendment are hyperlinked to corresponding portions of the side-by-side table in Appendix B.
Selected Issues
The following sections provide a discussion of the key provisions in H.R. 2749 as passed by the
House and the Senate 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 Senate
provisions refer to provisions in the Senate amendment (or “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 (53) 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
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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 (53) 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.
Recordkeeping
Should Documentation Requirements and Access to Records Be Strengthened?
Pursuant to provisions in P.L. 107-188, the Bioterrorism Act (FFDCA § 414; 21 U.S.C. § 350c),
the FFDCA authorizes the HHS Secretary to impose record-keeping requirements on domestic
and foreign food facilities (except farms and restaurants), and to inspect and copy such records
“[i]f the Secretary has a reasonable belief that an article of food is adulterated and presents a
threat of serious adverse health consequences or death to humans or animals.” The Secretary must
take appropriate measures to ensure that unauthorized disclosure of any trade secret or
confidential information is prevented. Through rulemaking, the Secretary has required facilities to
maintain records that allow for the identification of the immediate previous sources and
immediate subsequent recipients of food.39
Advocates of food safety reform often argue that record-keeping requirements must be
strengthened to help regulators determine whether firms are complying with the law, and to
facilitate outbreak investigations and product recalls. Among their concerns is that records do not
have to be maintained in electronic format, which, these advocates assert, delays outbreak
response. Related concerns include the types and level of detail of records to be kept, how long
they should be retained, and access to and use of these records by authorities. For example, is the
current “trigger” for accessing records (quoted above) too stringent to assure food safety, too
permissive to protect industry interests, or appropriately balanced between the two? Concerns
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.

39 FDA, “Establishment and Maintenance of Records Under the Public Health Security and Bioterrorism Preparedness
and Response Act of 2002,” 69 Federal Register 71561, December 9, 2004. Facilities are required to retain records for
specified periods of time, up to a maximum of two years, depending on the type of food.
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Legislative Proposals
The House-passed bill (61) would expand the Secretary’s authority to inspect and copy relevant
records of a food facility in order to determine whether a food is adulterated or misbranded, by
removing the requirement that the Secretary have “a reasonable belief that an article of food is
adulterated and presents a threat of serious adverse health consequences or death to humans or
animals.” Removing this requirement would authorize access to records during routine
inspections. The bill also would remove the requirement to provide written notice before having
such access, and would authorize the Secretary to require that records be kept for up to three
years and be maintained in a standardized electronic format. Farms would generally remain
exempt from the requirement to provide access to records unless the Secretary determined, with
respect to specified commodities, that such commodities posed a risk to public or animal health,
or were the subject of an active investigation of a foodborne illness outbreak. Restaurants would
be required to provide access to records, but would only have to keep records regarding their
suppliers and any subsequent distribution other than to consumers.
The Senate amendment (61) 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
likely to be affected in a similar manner, but would need to believe there is at least a risk of harm.
Unlike the House bill, farms and restaurants would (as under current law) be fully exempt from
this provision. For other facilities, written notification would still be required to gain access.
(See the subsequent section on “Notification of Contaminated Products and Product Tracing”)
Hazard Analysis and Risk-Based Preventive Controls
Reactive vs. Preventive Intervention
A broad consensus of policymakers agrees that FDA’s system of food safety safeguards should be
more proactive in addressing the nation’s complex food supply.40 By and large, the agency’s
statute and regulations spell out the reasons a food article is to be considered adulterated or
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.

40 Emily Ethridge, “Food Safety Bill Advances,” CQ Markup and Vote Coverage, Senate Health, Education, Labor and
Pensions Committee Markup of S. 510, November 18, 2009.
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A recurring theme now in discussions of food safety modernization is prevention. Virtually all
stakeholders, including regulators, the regulated industries, consumer advocates, and food safety
scientists agree that the foundations of any new program should be an understanding of what, and
how, hazards can enter the food supply, followed by implementation of measures to prevent these
hazards.41 A popular version of this approach is the so-called HACCP system, which many private
companies already use, and which was incorporated in the 1990s by FSIS as a regulatory
requirement for all meat and poultry slaughtering and processing establishments.42 Variations of
the HACCP system also are required by FDA in the processing of seafood, juices, and low-acid
canned foods, but not other product categories.
Committees of the National Academy of Sciences’ National Research Council (NAS-NRC) have,
in a number of reports, recommended the HACCP approach for food safety. For example, its
Committee on the Review of the Use of Scientific Criteria and Performance Standards for Safe
Food stated at the outset of a 2003 report:
The balance of progress in reduction of certain human foodborne illnesses following
implementation of [HACCP] in various areas of the food industry is decidedly favorable.... The
committee believes that the emphasis of food safety regulatory agencies must continue to be on
prevention, reduction, or elimination of foodborne hazards along the food continuum.43
The National Advisory Committee on Microbiological Criteria for Foods, established to offer
ongoing advice to the FDA and USDA, agreed with the NAS-NRC recommendations, which have
dated at least to the early 1990s. The advisory committee also noted that HACCP principles
should be standardized to provide uniformity in training and applicability, but also must be
developed by each food establishment so they can be tailored to individual products, processing,
and distribution conditions.44
Legislative Proposals
The House-passed bill and Senate amendment (54, 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

41 Testimony of Margaret A. Hamburg, FDA Commissioner, before the U.S. Senate Committee on Health, Education,
Labor, and Pensions, October 22, 2009; Committee on the Review of the Use of Scientific Criteria and Performance
Standards for Safe Food, National Research Council, Scientific Criteria to Ensure Safe Food, National Academies
Press, 2003; Center for Science in the Public Interest (CSPI), “Building a Modern Food Safety System for FDA
Regulated Foods,” May 2009; Consumers Union, August 1, 2008, letter to the U.S. House of Representatives.
42 Savage, Robert A. and Daniel Lafontaine, “HACCP Principles: Benchmark for Food Safety,” Food Quality
magazine, February/March 2010, http://www.foodquality.com/. Also see CRS Report RL32922, Meat and Poultry
Inspection: Background and Selected Issues
.
43 Committee on the Review of the Use of Scientific Criteria and Performance Standards for Safe Food, National
Research Council. Scientific Criteria to Ensure Safe Food, National Academies Press, 2003.
44 National Advisory Committee on Microbiological Criteria for Foods, Hazard Analysis and Critical Control Point
Principles and Application Guidelines
, adopted August 14, 1997.
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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 requirements regarding available FDA guidance documents for seafood (see 92 and 54)
that are not in the House-passed bill.
Performance Standards
Can Safety Be Better Measured?
Performance standards typically are specific, quantitative measurements of a property of, or a
substance in, food that are selected to serve as benchmarks for whether the food is safe in a
broader sense. For example, a microbial performance standard could be used to determine
whether a product is contaminated with microbes in general, and whether a problem with the
product’s processing should be investigated and corrected. The NAS-NRC standards committee
reported that a common theme of regulatory performance standards is “to provide clear
articulation of what is and is not acceptable in the process or system being regulated.”45 The
committee added that regulators like the FDA, USDA, and the Environmental Protection Agency
(EPA) have employed specific standards for diverse reasons and conditions and based on
numerous scientific, legal and practical constraints, including:
tolerances (which set legal limits) on the presence of chemicals in food, prohibitions on specific
microbial pathogens in specific foods, standards for process control, and standards defining the
acceptable outcome of a food process for reducing pathogenic contamination. All of these are
performance standards in the sense that they define what must be achieved in controlling risk
factors for food safety.46
The FFDCA does authorize FDA to promulgate standards for certain hazards, such as tolerances
for pesticide or drug residues in foods, but does not grant explicit authority to develop standards
solely as a means to verify that processing is done in a manner that ensures safe food.47
Legislative Proposals
The House bill and Senate amendment both include language on performance standards (56,
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

45 Committee on the Review of the Use of Scientific Criteria and Performance Standards for Safe Food, National
Research Council, Scientific Criteria to Ensure Safe Food, National Academies Press, 2003, p. 16.
46 Ibid, p. 17.
47 FSIS in 1996 had established two performance standards to verify the microbial safety of meat and poultry products
as part of its HACCP regulation. FSIS’s efforts to take enforcement action for violations of its standard upper limit for
Salmonella contamination were constrained by a successful legal challenge, but it still interprets noncompliant
Salmonella test results as a HACCP violation rather than a specific violation of the standard. For more information see
CRS Report RL32922, Meat and Poultry Inspection: Background and Selected Issues.
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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 to be “[b]ased on such review and evaluation, and when appropriate to
reduce the risk of serious illness or death to humans or animals or to prevent the adulteration of
food” under the FFDCA. The Senate 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. Viewpoints diverge on whether this should be
mandatory or voluntary. Should farmers and ranchers be subject to mandatory safety standards,
enforced through certification of their practices, periodic inspections, and penalties for
noncompliance? Or, should public policy continue to encourage voluntary strategies for
producing safe foods on farms and ranches, through education, cooperation, and market-based
incentives? Historically, the federal and state governments have largely relied on the latter
approach. In addition, numerous existing laws and regulations already impose restrictions, both
direct and indirect, on producers of food commodities; these restrictions involve compliance costs
and are intended to meet certain food safety objectives. They include requirements on the use of
animal drugs, feed additives, and pesticides.
FDA’s “current good manufacturing practice” (CGMP) requirements (at 21 C.F.R. Part 110) apply
to manufacturing, packing, or holding human food, but establishments engaged solely in
harvesting, storing, or distributing raw agricultural commodities generally are excluded.48 Farms
are among those exempted from a requirement that food facilities be registered with FDA,
pursuant to the Public Health Security and Bioterrorism Preparedness and Response Act of
2002.49 Further, the FFDCA specifically exempts farms (and restaurants) from requirements to
maintain records for up to two years for purposes of identifying “immediate previous sources and
the immediate subsequent recipients of food, including its packaging, in order to address credible
threats of serious adverse health consequences or death to humans or animals,” and to permit
officials access to these records if a food is suspected of being adulterated and presenting a
serious health threat.50

48 21 C.F.R. 110.19(b). The FFDCA at 21 U.S.C. § 321(r) defines a “raw agricultural commodity” as “any food in its
raw or natural state, including all fruits that are washed, colored, or otherwise treated in their unpeeled natural form
prior to marketing.”
49 P.L. 107-188; 21 U.S.C. 350(d).
50 21 U.S.C. 350c and 21 U.S.C. § 374. Dr. Andrew C. von Eschenbach, FDA Commissioner, observed that produce
farms generally do pack and hold food for introduction into interstate commerce, so it can and does inspect them
periodically, usually in areas associated with illness outbreaks or to conduct surveillance sampling. Source: U.S.
Congress, House Committee on Appropriations, Subcommittee on Agriculture, Rural Development, Food and Drug
Administration, and Related Agencies, Appropriations for 2008, 110th Cong., 1st sess., February 28, 2007 (Washington:
GPO, 2007), pp. Part 5, p. 479.
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FDA’s general approach has been not to impose mandatory on-farm safety standards or
inspections of agricultural facilities.51 Rather, the agency tends to rely on farmers’ adoption of so-
called good agricultural practices to reduce hazards prior to harvest. Such practices are issued as
FDA guidance, not regulations.52 In July 2009, the Obama Administration released new draft
guidances on three specific types of produce: tomatoes, melons, and leafy greens.53 However,
FDA’s final rule (effective July 2010) requiring shell egg producers to implement on-farm safety
measures to prevent contamination of eggs by Salmonella Enteritidis (SE) is one example of FDA
regulatory activity on-farm.54
Legislative Proposals
Several provisions in the House-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 (57, respectively).
The House-passed bill would require the Secretary, in consultation with the Secretary of
Agriculture, to publish a notice of proposed rulemaking, and within three years after such date,
final rules, establishing scientific and risk-based standards for the safe growing, harvesting,
processing, packing, sorting, transporting, and holding of those types of raw agricultural
commodities that are a fruit, vegetable, nut, or fungus, and for which the Secretary has
determined such standards are reasonably necessary to minimize the risk of serious adverse health
consequences or death to humans or animals. The House-passed bill states that these regulations
could set forth procedures and practices that the Secretary determines to be reasonable to prevent
known or reasonably foreseeable biological, chemical, and physical hazards, including natural
ones, that may be intentionally or unintentionally introduced. These regulations could include
minimum safety standards, and address manure use, water quality, employee hygiene, sanitation
and animal control, and temperature controls, as the Secretary determines to be reasonably
necessary. They may provide for coordination of education and enforcement activities and must
provide a reasonable time for compliance, taking into account the needs of small businesses for
additional time, among other permitted activities. The Secretary would be required to take into
consideration (consistent with public health) “the impact on small-scale and diversified farms,

51 The FDA advisory panel acknowledged that “[t]he Agency conducts no inspections of retail food establishments or
of food-producing farms.” FDA Science and Mission at Risk: Report of the Subcommittee on Science and Technology,
November 2007, p. 21.
52 Most FDA guidance documents include the following: “FDA’s guidance documents, including this guidance, do not
establish legally enforceable responsibilities. Instead, guidances describe the Agency’s current thinking on a topic and
should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of
the word should in Agency guidances means that something is suggested or recommended, but not required.” Sources:
FDA, Guidance for Industry: Guide to Minimize Microbial Food Safety Hazards of Leafy Greens, Draft Guidance, July
2009; and FDA, Guide to Minimize Microbial Food Safety Hazards of Fresh-cut Fruits and Vegetables, February 2008.
53 FDA, Guide to Minimize Microbial Food Safety Hazards of Tomatoes, Guide to Minimize Microbial Food Safety
Hazards of Melons, and Guide to Minimize Microbial Food Safety Hazards of Leafy Greens. Available at FDA’s
website: http://www.fda.gov/Food/GuidanceCompliance
RegulatoryInformation/GuidanceDocuments/ProduceandPlanProducts/default.htm. 74 Federal Register 38437-38440,
August 3, 2009. See also FDA, “FDA Issues Draft Guidances for Tomatoes, Leafy Greens and Melons,” July 31, 2009.
54 FDA, “Prevention of Salmonella Enteritidis in Shell Eggs During Production, Storage, and Transportation; Final
Rule,” 74 Federal Register 33029, July 9, 2009. See also FDA, “Egg Safety Final Rule,” http://www.fda.gov/Food/
FoodSafety/Product-SpecificInformation/EggSafety/EggSafetyActionPlan/ucm170615.htm.
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and on wildlife habitat, conservation practices, watershed-protection efforts, and organic
production methods” (57).
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 could 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,
organic, direct-to-market, and sustainable farming operations; and small livestock operations.55 At
issue is whether numerous proposed requirements would be more costly and burdensome to small
farms and other small businesses than could be justified by the potential public health protections
such requirements are intended to provide.
Considerations for small business could take many forms, including waiving certain
requirements, providing additional time for compliance, providing grants and/or technical
assistance to aid in compliance, and exempting certain types of businesses from meeting the
requirements. Currently the FFDCA exempts some types of businesses from certain food safety
requirements. For example, farms, restaurants, other retail food establishments, and certain
nonprofit food establishments and fishing vessels are exempt from facility registration
requirements under FFDCA § 415.
Various approaches might be used to define whether a farm or food processor is a “small”
business. Often, a definition may be based on a particular threshold value for a financial or
business measure, such as annual income or value of sales, numbers of employees, or other
measures.
With respect to farming operations, USDA typically relies on measures of gross cash income as a
measure of the size of a farm business. Gross cash income refers to the sum of all receipts from
the sale of crops, livestock, and farm-related goods and services, including any direct payments
from the government. For purposes of classifying farms, USDA defines a “small commercial

55 See CRS Report RL34612, Food Safety on the Farm: Federal Programs and Legislative Action.
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farm” as an operation with gross cash income of $10,000 to less than $250,000 annually; “large
farms” are defined as farms with gross cash income of $250,000 to less than $1 million.56 USDA
defines farms with gross cash income of less than $10,000 annually as very small, non-
commercial farms. Under these definitions, USDA data indicate that about one-third of all crop
and livestock producers are considered “small commercial” farms (Table 2). The share of small
commercial farms will vary depending on commodity. For example, among fruit and vegetable
producers who might be affected by requirements under the House and Senate food safety
measures, the share of small commercial farms is roughly 10% of all growers in this category.57
The size threshold used and the type of income counted to define a small business varies in
legislation and by agency. For example, the Small Business Administration (SBA) has set
different thresholds for defining a small business that vary considerably from USDA: among
most crop and livestock producers, SBA defines as a small business those who make no more
than $750,000 in sales per year.58 In some cases, however, USDA uses SBA’s definition for
defining a small business. Specifically, SBA’s threshold of $750,000 in annual sales is used by
USDA to determine small and very small meat and poultry plants as part of FSIS’s outreach and
oversight activities under its HACCP implementation and laboratory testing programs.59 Under
SBA’s business size standards, more facilities would be considered small businesses, with up to
one-half of all commercial crop and livestock producers defined as small.60
Elsewhere in farm legislation, such as in the periodic omnibus farm bill,61 adjusted gross income
(AGI)
is an alternative income measure that is generally used to differentiate farm size. AGI is a
common measure of income for tax purposes, combining income from all sources. Business
income contributes to AGI on a net basis, that is, after business expenses. Thus, it is comparable
to profit: sales minus expenses and also taxable deductions. In the farm bill, an AGI limit is used
to differentiate wealthier farm households as a means test for the maximum amount of income
that an individual can earn and still remain eligible for commodity program benefits, including
any direct payments from the government. The 2008 farm bill tightened these limits by reducing
the AGI limit to $500,000 of non-farm AGI and $750,000 of farm AGI.62 Given that most
business information is proprietary, data are limited on the share of commodity producers (farms
and food processors) that have an annual AGI of less than $500,000. Information for U.S. farms
indicates that farms with less than $500,000 AGI account for the vast majority (more than 95%)
of farm numbers.63

56 Hoppe, R.A., “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 Hoppe, R.A., Small
Farms in the United States: Persistence Under Pressure
, EIB-63, USDA, February 2010, http://www.ers.usda.gov/
publications/eib63/. Based on 2007 survey data.
57 Ibid., Figure 3.
58 Small Business Size Regulations, Title 13 C.F.R. Part 121.
59 Correspondence between CRS personnel and askFSIS (http://www.fsis.usda.gov/).
60 Based on data on farms that make up to $1 million. USDA survey data are not published for farms that generate
between $500,000 and $750,000 in annual sales.
61 The most recent farm bill was the Food, Conservation, and Energy Act of 2008, P.L. 110-246. For more information,
see CRS Report RL34594, Farm Commodity Programs in the 2008 Farm Bill.
62 Ibid.
63 The White House, “Strengthening the Rural Economy—Improving America’s Support of Agriculture,”
http://www.whitehouse.gov/administration/eop/cea/factsheets-reports/strengthening-the-rural-economy/improving-
americas-support-of-agriculture. Based on USDA data from the 2007 Department of Agriculture’s Agricultural
Resource Management Survey: http://www.ers.usda.gov/Briefing/FarmIncome/govtpaybyfarmtype.htm.
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Table 2. U.S. Farms and Food Manufacturers, 2007
(by size based on average annual sales receipts)
Farms and Food Manufacturing Establishments
Number
Percent
All Farms, Total
2,204,792
100.0%
Less than $10,000 (defined by USDA as “very small, non-commercial” farms)
1,271,735 57.7%
Between $10,000-$249,000 (defined by USDA as “smal commercial” farms)
715,947
32.5%
Between $250,000-$499,000
96,251
4.4%
More than $500,000
120,859
5.5%
All Food Manufacturing, Totala


Total, All Food Manufacturers
25,796 100.0%
Less than $500,000
8,906
34.5%
Selected Food Manufacturing Sectorsb


Grain and Oilseed Milling, Total 830
100.0%
Less than $500,000
71
8.6%
Fruit/Vegetable Manufacturing, Total
1,668
100.0%
Less than $500,000
203
12.2%
Dairy Product Manufacturing, Total
1,612
100.0%
Less than $500,000
174
10.8%
Animal Slaughtering and Processing, Total
3,817
100.0%
Less than $500,000
784
20.5%
Seafood Preparation/Packaging, Total
685
100.0%
Less than $500,000
114
16.6%
Bakeries/Tortilla Manufacturing, Total
10,269
100.0%
Less than $500,000
5,835
56.8%
Other Food Manufacturing, Total
3,310
100.0%
Less than $500,000
671
20.3%
Source: Data for farms are from USDA, 2007 Census of Agriculture, Table 58, December 2009,
http://www.agcensus.usda.gov/Publications/2007/Full_Report/Volume_1,_Chapter_1_US/st99_1_058_058.pdf.
Data for manufacturing establishments are from the U.S. Census Bureau’s 2007 County Business Patterns based on
annual survey data for al food manufacturers on the number of establishments by “enterprise receipt size,”
http://www.census.gov/econ/susb/.
Notes: “Average annual sales” includes market value of agricultural products sold and government payments.
Farm size designations are those described by USDA in Small Farms in the United States: Persistence Under Pressure,
EIB-63, February 2010, http://www.ers.usda.gov/publications/eib63/. For manufacturing, industry classification is
based on 2002 North American Industry Classification System (NAICS) codes.
a. Included in this total, but not shown separately are data for sugar and confectionery and animal food
manufacturing.
b. Ranked in order by NAICS code but including sugar and confectionery and animal food manufacturing.

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Data are not available indicating what share of all farms also engages in food processing. Such
operations might include fruit and vegetable producers that pack or further process the produce
they grow by making products such as jams, jellies, or juices, or other processed fruit and
vegetable products; other examples might include dairies that are also producer-handlers that
bottle their own milk. Also, only limited data are available that generally characterize the market
and producer channels for so-called locally or sustainably produced foods, or other direct-to-
market foods.64
For food processors and manufacturers, often different business measures are used to define small
businesses. SBA definitions of small food processors are based on the number of employees at a
business. Given that most farms do not employ large numbers of workers, size standards based on
the number of employees are generally not applicable to farming operations. Among most food
processors, a small business is defined by the SBA as a business with no more than 500
employees.65 By this definition, nearly all (97%) of all food processors would be considered small
businesses based on U.S. Census Bureau data.66 The U.S. Census Bureau also tabulates data for
manufacturing facilities based on annual sales receipts (Table 2).
FDA regulations also define certain small food processing businesses, but they are case by case
and not inclusive. For example, FDA’s current HACCP regulations exempt “small” juice
processors as those “employing fewer than 500 persons.”67 Accordingly, available data indicate
that as many as 84% of businesses that make juice are not covered by the HACCP requirements.68
Very small businesses are also exempt, and so defined by FDA if they meet one of the following
three criteria: “annual sales of less than $500,000, total annual sales greater than $500,000 but
total food sales less than $50,000, or operations that employ fewer than an average of 100 full-
time equivalent employees and sell fewer than 100,000 units of juice in the United States.”69
Available data indicate that about 12% of all fruit and vegetable manufacturers have annual sales
less than $500,000 (Table 2). Producers of “raw agricultural ingredients of juice,” such as fruit
and vegetable growers, are not covered by the HACCP requirements.
Legislative Proposals
Although both the House-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.
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

64 See for example Martinez, S. et al., Local Food Systems, Concepts, Impacts, and Issues, ERR-97, USDA, May 2010,
http://www.ers.usda.gov/Publications/ERR97/ERR97.pdf; and Hoppe, R.A. et al., Small Farms in the United States,
Persistence Under Pressure
, EIB-63, USDA, February 2010, http://www.ers.usda.gov/Publications/EIB63/EIB63.pdf.
65 Small Business Size Regulations, Title 13 C.F.R. Part 121.
66 Based on annual survey data for all food manufacturers on the number of firms broken out by employment size of the
enterprise. U.S. Census Bureau, 2007 County Business Patterns, http://www.census.gov/econ/susb/.
67 Hazard Analysis And Critical Control Point (HACCP) Systems, Title 21 C.F.R. Part 120.
68 U.S. Census Bureau, 2007 County Business Pattern. Data for “Frozen Fruit, Juice, and Vegetable Manufacturing.”
69 Hazard Analysis And Critical Control Point (HACCP) Systems, Title 21 C.F.R. Part 120.
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on on-farm activity, especially produce growers, would be the establishment of new standards for
produce safety (57, 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 (53 of the
House-passed bill; 53 of the Senate amendment); records access and/or inspection requirements
(61 of H.R. 2749; 61 and 62of the Senate amendment); food traceability requirements (62of H.R.
2749; 62of the Senate amendment); hazard analysis and risk-based preventive controls (§ 103 of
the Senate amendment); targeting of inspection resources (59 of the Senate amendment); and
changes in the reportable food registry (72 of H.R. 2749). For more information, see CRS Report
RL34612, Food Safety on the Farm: Federal Programs and Legislative Action.
The extent to which these other provisions might actually affect small business and farming
operations remains unclear, since the specific business requirements under these provisions would
be subject to agency rulemaking. In addition, what constitutes a “small” and a “very small”
business would be “as defined by the [HHS] Secretary” (see, for example, 54 of the House-passed
bill, and 54, 57, and 62 of the Senate amendment).
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. 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” (53). 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” (57).
S. 510 was first modified by the Senate HELP Committee to require that the HHS Secretary
“provide sufficient flexibility to be applicable to various types of entities engaged in the
production and harvesting of raw agricultural commodities, including small businesses and
entities that sell directly to consumers, and be appropriate to the scale and diversity of the
production and harvesting of such commodities” (54 and 57, 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 57). These
provisions were retained in the Senate amendment to S. 510.
The Senate amendment includes additional modifications 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 §61, 54, 57, and 62). 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
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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
safety measure reaches the Senate floor in the 111th Congress.70 Senator Tester first announced in
spring 2010 that he planned to introduce two amendments to the Senate committee-reported bill,
S. 510.71 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.”72
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.73 The modified Tester-Hagan amendment would establish “modified
requirements for qualified facilities” for so-called “very small” businesses, among other
provisions for both small and very small businesses (to be defined by HHS in regulation). Under
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 preventive food safety controls and evidence
that they are in compliance with state, local, county, or other applicable non-federal food safety
laws, among other documentation. Such modified requirements would apply to producers
considered “very small” and would include operations that have annual sales of less than
$500,000 (defined not as AGI, but as the three-year average “annual monetary value of sales,”
adjusted for inflation) and whose value of sales directly to “qualified end-users” exceeds all other
sales. Qualified end-users would include consumers or a restaurant or retail food establishment
that is located in the same state or less than 400 miles74 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.

70 Senator Tester press release, “Updated Food Safety Amendment Protects Small Producers,” September 24, 2010,
http://tester.senate.gov/Newsroom/pr_092410_foodsafety.cfm.
71 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).
72 Ibid.
73 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.
74 The 400-mile designation is similar to the distance specified in a provision of the Food, Conservation, and Energy
Act of 2008 (P.L. 110-246, Section 6015). That provision defines a “Locally or Regionally Produced Agricultural Food
Product” as any agricultural food product that is grown, produced, and distributed near where it is marketed such that
“the total distance that the product is transported is less than 400 miles from the origin of the product.”
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It is not possible to estimate what share of all food processing operations might be exempt from
the facility registration requirements under FFDCA § 415 or how other small business
considerations in both the House and Senate measures might possibly mitigate the effects of the
proposed produce safety standards and traceability requirements. In part, this is because the
definition of small and very small business would be defined by HHS in future agency
rulemaking and subject to other requirements specified in the measures. Even though farms
would continue to be exempt from the proposed facility registration requirements, there are farms
that also engage in food processing that might be affected. Data are not available to determine
what share of farms also engage in food processing. In addition, other stipulations within the
Tester-Hagen amendment would require that foods be sold locally and to certain qualified end-
users. Data are also not available to determine what share of grower-processors might qualify for
such an exemption; such a determination would likely be made on a case-by-case basis.
Many farm groups have expressed support for the Tester-Hagen amendment.75 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.76
In addition to broader industry concerns about the need to preserve consumer confidence in the
safety of all marketed produce, another industry concern is whether small foreign producers
might also be exempt, if small U.S. producers were to be exempt (given prevailing U.S.
equivalency standards).77
Some public health and consumer groups have expressed concern that the proposed amendments
would create “too great a loophole” in the food safety requirements, among other concerns.78 In
October 2010, a coalition of these groups expressed its opposition to the current version of the
Tester-Hagen amendment.79 The groups cited concern that the exemption was based only on sales
volume and could result in certain high-risk foods being exempted from food safety protections,
and whether labeling requirements were needed for such foods. They argued that it is unclear how
many facilities would be exempted under the proposed sales threshold, and that FDA should
conduct market analyses to determine appropriate thresholds for exemption in both the produce
and processed food sectors. They also questioned the appropriateness of the 400-mile designation
and other aspects of what would constitute a “direct sale” under the amendment, such as whether
grocery stores and restaurants should be included.

75 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.
76 United Fresh Produce Association, 2010 Issues Brief, http://www.unitedfresh.org/assets/
Issue_Brief_United_Fresh_Produce_Association_2010.pdf.
77 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.
78 Letter to Senator Tester from the Consumers Union regarding Amendments to S. 510, the FDA Food Safety
Modernization Act, April 20, 2010, http://www.consumersunion.org/campaigns//notinmyfood/016345indiv.html; and
articles in Food Safety News (http://www.foodsafetynews.com/); Helena Bottemiller, “Public Health Opposition to
Tester Amendment,” April 28, 2010; Helena Bottemiller, “Farmers Gain in Senate Food Safety Battle,” April 15, 2010;
and Alex Ferguson, “What’s Wrong with the Tester Amendments,” May 4, 2010.
79 Make Our Food Safe coalition, October 19, 2010, http://www.makeourfoodsafe.org/. The coalition’s white paper on
the Tester-Hagen amendment is at https://ssl.capwiz.com/pew/attachments/TesterResponsefactsheetfinal.pdf.
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Targeting of Inspections
How Often Should Plants Be Visited?
Reform advocates argue that many of the recent problems that have led to illness outbreaks and
recalls might have been avoided if inspectors were more frequently present in plants to monitor
sanitary conditions and processes.80 Due to the differing laws and circumstances that apply to
FSIS, for example, the agency’s inspectors are in meat and poultry slaughter and processing
plants every day, where they must organoleptically (by the senses) examine every live animal and
every carcass for defects, and must pass every item before it can enter commerce. The FFDCA
authorizes but does not require FDA to inspect food facilities. Therefore, no periodic inspection
frequency is currently stipulated. On the other hand, nothing in current law appears to prohibit
FDA from setting an inspection frequency, or prioritizing inspections based on risk.
Some, including former and current FDA officials, have argued that the agency lacks sufficient
resources to conduct the number of inspections required to ensure the safety of the food supply,
particularly in light of the increasing number of registered food facilities.81 (See Table 3.)
Table 3. FDA Food-Related Inspection Data, FY2004-FY2011
(Budget for Field Salaries and Expenses (S&E), Number of Field Full Time Equivalents (FTEs), Total
Number of FDA and State Inspections, and Cumulative Number of Domestic and Foreign Facilities
Registered under FFDCA § 415)

FY2004 FY2005 FY2006 FY2007 FY2008 FY2009 FY2010 FY2011
Field S&E ($ in
millions)a
$299.3 $283.3 $285.3 $298.0 $340.6 $479,9 $547.5 $705.2
Field FTEsa
2,172 2,059 1,962 1,806 1,861 2,166 2,505 2,902
Inspectionsb
21,876 19,774 17,730 17,038 16,277 17,972 20,542 22,205
Domestic Facilitiesc 121,534 148,451 172,190 194,245 214,584 236,398 252,433d N/A
Foreign Facilitiesc
92,719 104,555 115,902 129,345 141,703 154,883 164,805d N/A
Source: Compiled by CRS from FDA annual budget documents for FY2006-FY2011.
a. Food field S&E and FTE data are from the FY2007-FY2011 annual Food and Drug Administration, President’s
Budget Request “All Purpose Table—Total Program Level,” except that the FY2004 numbers are from the
FY2006 annual Food and Drug Administration, President’s Budget Request, “Narrative by Activity, Foods—
Center for Food Safety and Applied Nutrition.” Appropriated funds are shown for FY2010; requested
funding levels are shown for FY2011. Actual funding levels are shown for FY2004-FY2009.
b. Inspection data are the reported Total FDA and State Contract Inspections, from the FY2006-FY2011
annual Food and Drug Administration, President’s Budget Request, Field Activities—Office of Regulatory

80 Lyndsey Layton, “FDA Inspections of Food Plants, Enforcement Down, Officials Say,” The Washington Post, April
7, 2010. This story refers to an HHS Inspector General report finding “significant weaknesses” in FDA’s domestic food
facility inspections program, including a significant decline in the number of inspections as well as a decline in the
number of violations identified by inspectors. HHS Office of Inspector General, “FDA Inspections of Domestic Food
Facilities,” OEI-02-08-00080, April, 2010, p. iii, http://oig.hhs.gov.
81 See, e.g., Hubbard, William, Former FDA Associate Commissioner for Policy and Planning, and Advisor, Alliance
for a Stronger FDA, March 11, 2009, testimony before the House Energy and Commerce Subcommittee on Health;
FDA Science Board, FDA Science and Mission at Risk: Report of the Subcommittee on Science and Technology,
November 2007; and “Science and Mission at Risk: FDA’s Self-Assessment,” January 29, 2008 Testimony of Peter
Barton Hutt before the Subcommittee on Oversight and Investigations, House Committee on Energy and Commerce.
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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.
According to FDA budget documents, while the number of registered facilities has increased each
year since FY2004, the number of food inspectors decreased by about 15% from FY2004 to
FY2008. Due in part to arguments for increased funding, appropriations for the agency’s field
activities and full time equivalents (FTEs) have risen each fiscal year since FY2007. (In FDA
budget documents, inspection-related items appear under the field heading, and employees are
counted as FTEs.) According to the same budget documents, the number of inspections of food
facilities has increased each year since FY2008, yet is not projected to return to FY2004 levels
until FY2011.
One additional issue is how FDA can best target its available inspection resources to protect the
public health. Different facilities may not merit the same frequency of inspection. For example,
facilities that process and package food may create a greater opportunity for contamination than
warehouses that merely store foods. Companies and facilities that have a record of meeting all
FDA requirements may present less of a risk than those that do not. Foods produced in countries
with food processing and handling standards at least as rigorous as those of the 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 59 and 81, and in the Senate amendment are 59
and 81.)
The House-passed bill would require the HHS Secretary to establish, within 18 months, a risk-
based schedule for inspecting each foreign and domestic food facility, following these prescribed
categories and frequencies: category 1, a high-risk food facility that manufactures or processes
food, must be inspected at least every 6-12 months; category 2, a low-risk facility that
manufactures or processes food or a facility that packs or labels food, must be inspected at least
every 18 months to three years; and category 3, a food facility that holds food, must be inspected
at least every five years.
The House-passed bill also would authorize the Secretary to modify the types of food facilities
within each category, and to alter inspection frequencies if needed to respond to illness outbreaks
and recalls. In doing so, the Secretary would be required to consider the type of food at the
facility, its compliance history, whether an importing facility is certified (under the new
certification requirements the bill would set; see below), and other factors determined relevant by
the Secretary.
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
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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
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.
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Use of Third Parties for Imports and for Laboratory Accreditation
Can Non-FDA Entities Help Ensure Safety?
Although FDA regulates importers and imported products, the agency does not have express
statutory authority to regulate private laboratories that sample or test imported foods, nor does
FDA accredit food laboratories or use others to certify the safety of imported foods. Presently,
laboratory accreditation is voluntary, and several domestic and international accreditation
organizations accredit laboratories.82 FDA may conduct voluntary, on-site assessments of private
accredited laboratories.83 FDA’s own laboratories are accredited and, according to FDA, “the
laboratory industry favors accreditation.”84 Industry participation in third-party certification
programs, such as those that help foreign and domestic producers meet FDA requirements
through certification, is also voluntary, although FDA has indicated that participation in such
programs may “be beneficial.”85 The FDA has also indicated that “there is extensive support for
certification programs that audit to determine compliance with internationally recognized
criteria,” and that domestic suppliers use third-party certification programs “in part because of
customer demand.”86
The Government Accountability Office testified in 2008 that private laboratory accreditation
“could leverage outside resources while providing FDA greater assurance about the quality of the
laboratories importers use to demonstrate that their products are safe.”87 In January 2009, FDA
issued draft guidance on accreditation standards for private laboratories and the test data that such
labs should submit to the agency for imported FDA-regulated products that were either detained
or subject to an FDA Import Alert.88 The guidance document encouraged importers to notify the
FDA in advance of their submission of a sample to an accredited laboratory, so as “to discourage
importers from withholding bad test results, re-testing, or re-sampling.”89 In January 2009, FDA
also issued a final guidance document on voluntary third-party certification programs for foods
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.

82FDA, “Guidance for Industry: Submission of Laboratory Packages by Accredited Laboratories ,” 74 Federal Register
3056-3057, January 16, 2009, hereinafter Draft Guidance.
83 Ibid.
84 Ibid.
85 FDA, “Guidance for Industry: Voluntary Third-Party Certification Programs for Foods and Feeds ,” 74 Federal
Register
3058-3059, January 16, 2009.
86 Ibid.
87 Draft Guidance, supra note 54 (citing GAO, Federal Oversight of Food Safety—FDA’s Food Protection Plan
Proposes Positive First Steps, but Capacity to Carry Them Out is Critical
, GAO-08-435T, at 7).
88 Draft Guidance.
89 Ibid.
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Additionally, critics contend that although third-party certification may be useful as a commercial
marketing tool, it does not necessarily ensure safety, as manufacturers involved in recent
foodborne illness outbreaks have passed private third-party and state inspections. For example, in
two of the most publicized recalls over the last two years—the recall of 380 million eggs by a
single company and the recall of over 3,900 peanut products associated with another—both
companies had used outside labs and reportedly knew of positive test results for Salmonella in
their products prior to the recalls.90
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 § 94 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 69 of the House-passed bill also contains requirements for new laboratory accreditation
programs, testing of imported food by accredited laboratories, recognition of laboratory
accreditation bodies, advance notice to the Secretary prior to sample collection for testing, and
direct submission to the Secretary of laboratory analyses for certain analytical testing of food.
The Senate amendment (§ 69) 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.

90 FDA, Update on the Salmonella Typhimurium Investigation, FDA/CDC Joint Media Teleconference, (Jan. 28,
2009), at 9, http://www.fda.gov/downloads/NewsEvents/Newsroom/MediaTranscripts/UCM169176.pdf; Gardiner
Harris and William Neuman, Salmonella Found in ’08 at Egg Farm, N.Y. Times, (September 15, 2010), at B1.
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Section 94 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 a requirement that laboratory test
results be sent to the FDA unless the Secretary exempts the submission of test results after
making a determination that the results “do not contribute to the protection of public health.”
Mandatory Recall Authority
Removing Unsafe Foods from Commerce
Currently, neither FDA nor FSIS has explicit statutory authority to mandate a recall of most
adulterated foods, or to impose penalties if recall requirements are violated. FDA can order food
recalls only for infant formula.91 GAO and others have contended that these gaps increase the
possibility that unsafe food will not be recovered, and will be consumed.92 Significantly,
reversing their earlier opposition, many major food industry groups now endorse legislative
proposals to grant FDA mandatory recall authority for food.93
Defenders of the current system counter that the agencies already have sufficient authority to
keep tainted products from reaching consumers. FSIS’s statutory authority enables it to detain
meat and poultry products of concern for up to 20 days, and FDA’s authority enables it to detain
the foods it regulates for up to 30 days. Both agencies can, with a court’s permission, seize,
condemn, and destroy unsafe food.94 However, given FDA’s finite resources, these authorities
may not be practical or effective when large amounts of product are in wide distribution. Private
companies rarely fail to order a voluntary recall when problems arise, and some contend that
providing FDA with mandatory recall authority might foster a counterproductive adversarial
relationship between industry and government, slowing response times. Nonetheless, a number of
Members of Congress have supported GAO’s recommendation that legislation be considered to
strengthen the notification and recall authorities of both agencies.
Legislative Proposals
The House-passed bill (§ 70) 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

91 FDA has the authority to order recalls of four types of products: infant formula, medical devices, human tissue
products, and tobacco products. The agency may request that a company voluntarily recall other FDA-regulated
products, such as other foods, drugs, and cosmetics. See also discussion of the melamine contamination incident in
CRS Report R40916, Food Safety: Foodborne Illness and Selected Recalls of FDA-Regulated Foods.
92 See, for example, GAO, Food Safety: USDA and FDA Need to Better Ensure Prompt and Complete Recalls of
Potentially Unsafe Food
(GAO-05-51), October 2004; and HHS Office of Inspector General (OIG), “FDA Inspections
of Domestic Food Facilities,” OEI-02-08-00080, April, 2010, http://oig.hhs.gov.
93 In reaction to a news story on an OIG report, representatives from the food industry noted the need for mandatory
recall in some instances. See “OIG Says Better FDA Traceback May Require New Legislation,” FDA Week, March 27,
2009.
94 A court’s permission may not be needed in all cases; for example, the FFDCA [§ 801(j)(1)] empowers officials to
hold an import for up to 24 hours if there is “credible evidence or information indicating that an article of food presents
a threat of serious adverse health consequences or death to humans or animals.”
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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 (§ 54), and importers to have adequate recall procedures (§ 64). In
addition, FDA could alter the frequency for risk-based inspection schedules based on the need to
respond to food recalls (§ 59), and could assess and collect fees from entities for any fiscal year in
which the entity is subject to a food recall (§ 80).
The Senate amendment (§ 70) 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.
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, it appears that food company
representatives were aware of a food safety problem for a prolonged period of time before
notifying FDA.95

95 See, for example, documentation on the 2010 Wright County egg recall available at the House Committee on Energy
(continued...)
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The 110th Congress responded to some of these concerns by including a provision in the Food and
Drug Administration Amendments Act of 2007 (P.L. 110-85) that requires the responsible party
for a food facility (i.e., registered under FFDCA § 415) to notify the Secretary of any food “for
which there is a reasonable probability that the use of, or exposure to, such article of food will
cause serious adverse health consequences or death to humans or animals,” and that requires the
Secretary to establish a Reportable Food Registry of such reports.96 Also, the enacted 2008 farm
bill (P.L. 110-246) amends the meat and poultry laws to require 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 (§ 72) would amend current authority for the Reportable Food Registry to
expand the definition of who must report problem foods. In addition to persons who register
facilities under FFDCA § 415, persons who own or operate farms and retail establishments would
also have to report, as would persons who register importing facilities under FFDCA § 801. In
addition, the bill would require 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 (§ 62) also would require the Secretary to establish by regulation a tracing
system for food in, or to be imported into, the United States, in order to enable the Secretary “to
identify each person who grows, produces, manufactures, processes, packs, transports, holds, or
sells such food in as short a timeframe as practicable but no longer than 2 business days.” Before
promulgating regulations, the Secretary would be required first to identify tracing technologies
and methodologies that can enable each of the food industry sectors to maintain the full pedigree
of the food from source through subsequent distribution, to make traceback interoperable with
other systems, and to use a unique identifier for each facility. Also prior to proposing regulations,
the Secretary would first have to, as practicable, assess costs, benefits, and feasibility of adopting
such technologies; conduct at least two public meetings; and conduct one or more pilots.
The House-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.”

(...continued)
and Commerce website: “Chairmen Request More Details on Salmonella Contamination at Wright County Egg
Publications,” September 14, 2010. See also discussion of the melamine contamination incident in CRS Report
R40916, Food Safety: Foodborne Illness and Selected Recalls of FDA-Regulated Foods.
96 FFDCA § 417; 21 U.S.C. 350f. After some delays, the Reportable Food Registry was implemented in September
2009. See the FDA website at http://www.fda.gov/Food/FoodSafety/FoodSafetyPrograms/RFR/default.htm.
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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 (§ 72) 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 (§ 62) 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.97 A foodborne disease outbreak is not defined in law or in regulations. In
public health practice, a foodborne disease outbreak is “the occurrence of two or more cases of a
similar illness resulting from the ingestion of a common food.”98 As a practical matter,
particularly for less serious hazards, outbreak investigations are rarely launched when only two
people are affected. (There are exceptions for serious illnesses such as botulism.)
The nation’s public health capacity for foodborne illness surveillance and outbreak response is a
mix of significant strengths and significant gaps.99 In the last decade or so, the linkage of
previously unrelated illnesses through genetic “fingerprinting” has revolutionized the ability to
identify large multistate outbreaks and mount an urgent response. However, the epidemiological
approaches used to identify the food associated with an outbreak can be labor-intensive and time-

97 FFDCA at 21 U.S.C. § 372 and 21 U.S.C. § 399; Public Health Service Act at 42 U.S.C. § 241, 42 U.S.C. § 243, 42
U.S.C. § 247b, 42 U.S.C. § 247b-20, and 42 U.S.C. § 264.
98 CDC, “Surveillance for Foodborne-Disease Outbreaks: United States, 1998–2002,” Morbidity and Mortality Weekly
Report (MMWR)
, vol. 55 (Surveillance Summary 10), pp. 1-34, November 10, 2006.
99 See CRS Report R40916, Food Safety: Foodborne Illness and Selected Recalls of FDA-Regulated Foods.
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consuming. Also, especially for FDA-regulated foods, information about common contaminants
that may be present in foods during production and in commerce, as well as how to test for them,
is limited. As a result, “attribution”—identifying the types of foods that cause foodborne
illnesses—remains a significant challenge. The daunting outbreaks of the past few years
underscore the problem, but are not the only evidence. Based on data from FoodNet, its active
surveillance system, CDC reported that as of 2009, the incidence of several of the foodborne
diseases under surveillance had reached a plateau, instead of declining, and that national 2010
health targets for three out of four targeted pathogens—Campylobacter, Listeria, and
Salmonella—may not be met.100
Because regulators regulate foods, rather than food contaminants, many contend that closing the
attribution gap is paramount in order to target preventive strategies efficiently and mount a more
nimble response to outbreaks. The President’s Food Safety Working Group stated one of its three
core food safety principles as follows: “High-quality information will help leading agencies know
which foods are at risk; which solutions should be put into place; and who should be
responsible.”101 Achieving this goal is a challenge, raising concerns about available technologies,
scientific soundness, intellectual property, “trade secret” protections, liability, and other issues.
Stakeholders discussed these issues at an FDA-sponsored public workshop in March 2010.102
Legislative Proposals
The House-passed bill (§ 75) would, for purposes of surveillance, define a foodborne illness
outbreak as two or more cases of a similar illness resulting from the ingestion of a food. The bill
would require the Secretary, acting through the CDC, to enhance foodborne illness surveillance
systems, including coordinating federal, state, and local systems; facilitating timely sharing of
agency findings; ensuring early notification of the food industry when a particular food is
suspected in an outbreak; developing improved epidemiological tools; and other prescribed
methods. The bill also would mandate a review of and strategies to enhance the food safety and
defense capabilities of state and local agencies.
The Senate amendment (§ 75) 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.

100 CDC, “Preliminary FoodNet Data on the Incidence of Infection with Pathogens Transmitted Commonly Through
Food–10 States, 2009,” MMWR, vol. 59, no. 14 (April 16, 2010), pp. 418-422, http://www.cdc.gov/foodnet/. CDC
reported that the target for harmful strains of E. coli had been met.
101 President’s Food Safety Working Group, “Key Findings,” March 2009, http://www.foodsafetyworkinggroup.gov/
ContentKeyFindings/HomeKeyFindings.htm.
102 FDA, “Measuring Progress on Food Safety: Current Status and Future Directions; Public Workshop,” 75 Federal
Register
9232, March 1, 2010.
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Criminal Penalties
Existing Criminal Penalties Under FFDCA § 303(a)
The concepts of “adulteration” and “misbranding” are two of the basic statutory components of
the FFDCA. FDA-regulated foods may be deemed adulterated or misbranded for a variety of
statutorily prescribed reasons. For example, food may be deemed adulterated if it contains an
added poisonous or deleterious substance or an unsafe food additive or if the food was prepared,
packed, or held under insanitary conditions whereby it may have become contaminated or may
have been rendered injurious to health.
Persons who violate the FFDCA by, for example, introducing an adulterated or misbranded
product into interstate commerce, commit what is referred to as a prohibited act under FFDCA §
301.103 Persons who commit prohibited acts are subject to criminal and civil penalties. The
penalties vary, depending on the offense. Most criminal liability provisions are found in the
“Penalties” section of the FFDCA, § 303. Injunctions and seizures may also be sought for
adulterated or misbranded products. In light of a number of deaths that appear to have resulted
from contaminated food, such as nine deaths linked to tainted peanut butter products, some have
called for stronger criminal penalties than the current fines and maximum of three years’
imprisonment.104
Presently, upon conviction for a misdemeanor violation of the prohibited acts section, a person105
faces the penalties authorized in FFDCA § 303(a).106 These are presented in Table 4. The
maximum criminal penalty for individuals (as adjusted by 18 U.S.C. §§ 3559 and 3571) is
imprisonment for one year and/or either $100,000 if the misdemeanor does not result in death, or
$250,000 if the misdemeanor results in death. The maximum criminal penalty for organizations
(as adjusted by 18 U.S.C. §§ 3559 and 3571) is $200,000 if the offense does not result in death
and $500,000 if the offense results in death. There are exceptions to the misdemeanor penalties
provisions in FFDCA § 303(a)(1). A person could avoid being subject to penalties for certain
violations of the prohibited acts section under the good faith exception, and persons may also
avoid liability for violations of certain prohibited acts if they receive a guaranty from the
manufacturer or the person from whom they received the product.107

103 21 U.S.C. § 331.
104 See U.S. Congress, House Committee on Energy and Commerce, Do You Fix Our Ailing Food Safety System, 111th
Cong., 1st sess., March 11, 2009 (http://energycommerce.house.gov/Press_111/20090311/testimony_dewaal.pdf); see
also U.S. Congress, Senate Committee on the Judiciary, statement of Sen. Patrick Leahy, Chairman, Executive
Business Meeting of the S. Comm. on the Judiciary, 111th Cong., 2nd sess., September 23, 2010
(http://judiciary.senate.gov/hearings/testimony.cfm?id=4808&wit_id=2629).
105 The FFDCA defines “person” to include individuals, partnerships, corporations, and associations, though criminal
statutes distinguish between individuals and organizations in setting fine amounts. FFDCA § 201(e); 18 U.S.C. §§
3559, 3571.
106 21 U.S.C. § 333(a)(1). In United States v. Dotterweich, the U.S. Supreme Court held that the government need not
prove that the defendant intended to commit a FFDCA violation in order to obtain a misdemeanor conviction.
Misdemeanor violations of the FFDCA are strict liability offenses. United States v. Dotterweich, 320 U.S. 277, 284
(1943); see also United States v. Park, 421 U.S. 658 (1975).
107 21 U.S.C. § 303(c)(1)-(3). FFDCA § 301(h) prohibits a person from giving a false guaranty to another person that a
food is not adulterated.
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Table 4. Criminal Penalties for Violations of FFDCA § 303(a)
Maximum Criminal
Maximum Criminal
Penalty for
Penalty for Individuals
Organizations (as
Description of Statutory
(as adjusted by 18 U.S.C.
adjusted by 18 U.S.C.
Statute
Provision
§§ 3559 and 3571)
§§ 3559 and 3571)
Current Law provisions
Federal Food, Drug,
Violation of FFDCA prohibited
Imprisonment for one year
$200,000 if the offense
and Cosmetic Act
acts provisions, FFDCA § 301
and/or either $100,000 if
does not result in death,
(FFDCA) § 303(a)(1)
the misdemeanor does not
$500,000 if the offense
result in death, or $250,000
results in death.
(21 U.S.C. § 333(a)(1))
if the misdemeanor results
in death.

FFDCA § 303(a)(2)
Violation of FFDCA prohibited
Imprisonment for not more
A fine of not more than
acts provisions after a prior
than 3 years or a fine of not
$500,000.
(21 U.S.C. § 333(a)(2)) conviction under FFDCA § 303 more than $250,000, or
or a violation committed with
both.
the intent to defraud or
mislead
Proposed changes
Proposed FFDCA §
Knowing violation of certain
Imprisonment for not more
A fine of not more than
303(a)(3), as set forth
FFDCA prohibited acts
than 10 years or a fine of
$500,000.
in H.R. 2749
provisions with respect to any
not more than $250,000, or
food that is misbranded or
both.
adulterated
Proposed FFDCA §
Knowing violation of certain
Imprisonment for not more
A fine of not more than
303(a)(3), as set forth
FFDCA prohibited acts
than 10 years or a fine of
$500,000.
in S. 3767a
provisions with respect to any
not more than $250,000, or
food and with conscious or
both.
reckless disregard of a risk of
death or serious bodily injury
Source: Prepared by CRS.
a. Not currently part of the Senate amendment.
A violation of the FFDCA’s prohibited acts section is a felony offense if it occurs after a prior
conviction for violating the FFDCA’s prohibited acts section or if it is committed with the intent
to defraud or mislead. The maximum criminal penalty for individuals convicted of a felony
violation of the FFDCA (as adjusted by 18 U.S.C. §§ 3559 and 3571) is imprisonment for not
more than three years or a fine of not more than $250,000, or both. The maximum criminal
penalty for organizations (as adjusted by 18 U.S.C. §§ 3559 and 3571) is a fine of not more than
$500,000.
Criminal liability may also extend to persons who aid and abet criminal violations of the FFDCA,
or who conspire to violate the FFDCA, as federal criminal law generally makes it a separate
crime to aid or abet any criminal offense against the United States or to conspire to commit a
criminal offense against the United States.108 The decision to seek criminal sanctions against
individuals and corporations suspected of violating the FFDCA is within the FDA’s discretion.109

108 18 U.S.C. §§ 2, 371.
109 Heckler v. Chaney, 470 U.S. 821 (1985) (holding that “[t]he FDA’s decision not to take the enforcement actions
(continued...)
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Prosecution may be more likely if the case involves “gross, flagrant, or intentional violations,
fraud, or danger to health” or “a continuous or repeated course of violative conduct.”110
Legislative Proposals
Section 134 of the House-passed bill would amend the penalties provisions of FFDCA § 303(a) to
provide for fines and a maximum prison sentence of 10 years if any person knowingly violated
any one of five listed prohibited acts with respect to food that is misbranded or adulterated. The
five prohibited acts listed in § 134 are (1) FFDCA § 301(a), which prohibits “the introduction or
delivery for introduction into interstate commerce” of any food that is adulterated or misbranded;
(2) FFDCA § 301(b), which prohibits adulteration or misbranding of food in interstate commerce;
(3) FFDCA § 301(c), which prohibits the “receipt in interstate commerce” as well as “the delivery
or proffered delivery thereof for pay or otherwise” of adulterated or misbranded food; (4) FFDCA
§ 301(k), which prohibits the “alteration, mutilation, destruction, obliteration, or removal of the
whole or part of the labeling of, or the doing of any other act with respect to, a food ... if such act
is done while such article is held for sale (whether or not the first sale) after shipment in interstate
commerce and results in the article being adulterated or misbranded”; and (5) FFDCA § 301(v),
which prohibits the “introduction or delivery for introduction into interstate commerce” of an
unsafe dietary supplement.
The maximum criminal penalty for individuals convicted of a felony violation of the FFDCA for
knowingly violating any one of these five parts of the FFDCA’s prohibited acts section, with
respect to any adulterated or misbranded food, would be a fine of not more than $250,000. Such
individuals would also face a maximum prison sentence of 10 years in addition to the fine, as the
individual could be fined, imprisoned, or both. The maximum criminal penalty for organizations
for such violations would be a fine of not more than $500,000.
The proposed Senate amendment to S. 510 would not alter the criminal penalties under FFDCA §
303(a). However, it has been reported that if it 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 a further amendment to it. A substitute amendment to S. 3767 was approved by the
Senate Judiciary Committee on September 23, 2010, and the bill as amended was reported by the
committee on the same day.
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

(...continued)
requested by respondents is therefore not subject to judicial review under the [Administrative Procedure Act]” and that
the FFDCA enforcement provisions do not overcome the agency’s “decisions not to institute proceedings”).
110 FDA, Regulatory Procedures Manual, § 6-5-1, March 2010, http://www.fda.gov/ICECI/ComplianceManuals/
RegulatoryProceduresManual/ucm176738.htm.
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FFDCA for knowingly violating these parts of the FFDCA’s prohibited acts section, “with respect
to food and with conscious or reckless disregard of a risk of death or serious bodily injury,”
would be a fine of not more than $250,000, imprisonment for up to 10 years, or both. The
maximum criminal penalty for organizations for such violations “with respect to food and with
conscious or reckless disregard of a risk of death or serious bodily injury” would be a fine of not
more than $500,000. Changes proposed by the House-passed bill and by S. 3767 are presented in
Table 4.
Food Imports
Concerns About Import Oversight
A steady increase in food imports, a result of globalization and consumer desire for a wider
variety of foods year-round, has generated growing concerns about whether current federal
programs sufficiently ensure the safety of these imports.111 FDA import alerts in 2007 and 2008
targeting adulterated pet food ingredients, farmed seafood, and dairy products and ingredients, all
from China, have been among the incidents that have heightened interest in this issue. Most of the
recent debate has included extensive discussion about how to improve current import safeguards,
within resource constraints, and without unduly restraining free trade.112
The FFDCA (at 21 U.S.C. § 381(a)) empowers FDA to refuse entry to any food import if it
“appears,” based on a physical examination or otherwise, to be adulterated, misbranded, or
otherwise in violation of the law. In exercising its oversight, the agency relies on a system of prior
notifications by importers and document reviews at ports of entry. Importers must have an entry
bond and file a notification for every shipment. An FDA database, the Operational and
Administrative System for Import Support (OASIS), helps inspectors to determine a shipment’s
relative risk and whether it needs closer scrutiny (i.e., a physical examination, and/or testing). In
practice, import inspections are relatively infrequent. The agency recorded more than 8.2 million
imported food “lines” in FY2007 (compared with fewer than 2.8 million entry lines in FY1997),
of which approximately 1% were physically examined and/or tested.113 Among the cited reasons
for this low incidence in inspections are limited and declining resources, including too few
inspectors to cover the more than 360 U.S. ports of entry despite ever-increasing import
volumes.114 Current law also does not explicitly authorize, or require, import verification.
In addition, some have questioned whether FDA has what is called “equivalence authority”, such
as that governing U.S. imports of meat and poultry products under USDA’s FSIS jurisdiction.115
“Equivalency” refers to the requirement that all imported meat and poultry products meet all

111 GAO, Food Safety: Agencies Need to Address Gaps in Enforcement and Collaboration to Enhance Safety of
Imported Food
, GAO-09-873, September 15, 2009; GAO, Food Safety: FDA Could Strengthen Oversight of Imported
Food by Improving Enforcement and Seeking Additional Authorities,
GAO-10-699T, May 6, 2010. See also CSPI,
“Building a Modern Food Safety System for FDA Regulated Foods, May 2009.
112 Additional information is available in CRS Report RL34198, U.S. Food and Agricultural Imports: Safeguards and
Selected Issues
.
113 FDA briefing for Senate staff, February 8, 2008. FDA FY2009 budget materials state that 94,743 import food field
exams were conducted in FY2007.
114 See, for example, Testimony of Caroline Smith DeWaal, CSPI Director of Food Safety, before the House Energy
and Commerce Committee’s Subcommittee on Oversight and Investigations, July 17, 2007.
115 Ibid.
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safety standards applicable to similar products produced in the United States. Foreign meat and
poultry food regulatory systems may apply “equivalent sanitary measures to eliminate or abate
food safety hazards” if those measures provide the same “level of public health protection”
achieved by U.S. measures.116 Under laws governing meat inspection,117 no foreign establishment
can ship its products to the United States until FSIS has determined that the establishment’s
country has a meat and/or poultry safety program that provides a level of protection that is at least
equivalent to the U.S. system. FSIS visits the exporting country to review its rules and
regulations, meets with foreign officials, and accompanies them on visits to establishments. In
addition, FSIS operates a reinspection program at 150 import houses located near approximately
35 border entry points. FDA does not have a program like that of FSIS. Some have suggested that
the FDA program should operate more like that of FSIS, although they acknowledge the
difficulties and resource demands of attempting to regulate many more different types of foods
from many countries of origin.118
Legislative Proposals
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 (§ 66), 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 (§ 80) 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.)

116 According to USDA, the concept that different sanitary measures can achieve the same level of protection is called
equivalence. See: USDA, Food Safety And Inspection Service, “Process for Evaluating the Equivalence of Foreign
Meat and Poultry Food Regulatory Systems,” October 2003, http://www.fsis.usda.gov/oppde/ips/eq/eqprocess.pdf.
117 Federal Meat Inspection Act, 21 U.S.C. §§ 601-695; and Poultry Products Inspection Act, 21 U.S.C. §§ 451-471.
118 See for example Testimony of Caroline Smith DeWaal, CSPI Director of Food Safety, before the House Energy and
Commerce Committee’s Subcommittee on Oversight and Investigations, July 17, 2007.
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The Senate amendment (§ 94) 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 (§ 73) also would authorize a “Foreign Supplier Verification Program,”
generally requiring each importer to perform foreign supplier verification activities in accordance
with regulations the Secretary would issue to ensure compliance with relevant FFDCA
provisions. Each importer’s program would be able to assure that each of its foreign suppliers
produces the imported food employing processes and procedures, “including reasonably
appropriate risk-based preventive controls” that are documented in a written plan and equivalent
in preventing adulteration and reducing hazards as required by other relevant provisions of the
FFDCA. Verification activities would include monitoring records, lot-by-lot certification of
compliance, annual on-site inspections, checking the preventive control plan of the foreign
supplier, and periodically testing and sampling shipments. Importers would maintain import
verification program records for at least two years and make them available to the Secretary upon
request. The House bill also contains provisions regarding foreign supplier verification (including
provisions in §§ 78, 80).
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 (§ 73) and a “Voluntary Qualified Importer Program” in the Senate amendment
(§ 73).
Bisphenol A (BPA)
Are Food Containers with BPA Safe? Are Alternatives Available?
Bisphenol A (BPA) is a component of certain plastics. When used in food containers, such as
plastic bottles or metal can liners, BPA is regulated by the FDA. Scientific disagreement about
possible human health effects that may result from BPA exposure has led to conflicting regulatory
decisions regarding the safety of these food containers, especially when intended for use by
infants and children.119 FDA’s conclusion in 2008 that BPA use is safe conflicted with findings of
advisory panels. This prompted some to question FDA’s risk assessment process, and its ability to
conduct such assessments. Recently, FDA expressed concern about possible health effects from

119 For additional background information, see CRS Report RS22869, Bisphenol A (BPA) in Plastics and Possible
Human Health Effects
.
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BPA exposure, and announced that it was conducting new studies on the matter, pending possible
changes in its regulatory approach.
In March 2009, several manufacturers of baby bottles announced that they would stop selling
BPA-containing bottles in the United States, partly in response to growing numbers of retailers
that would no longer carry the products.120 However, manufacturers of cans maintain that suitable
alternatives to BPA are not available and are not likely to become available in the immediate
future. Until alternatives for all uses are developed, they argue that BPA-containing liners will be
necessary to ensure a tight seal on cans and lids, and thus to prevent food spoilage and food
poisoning risks to consumers. Manufacturers are seeking alternatives to meet consumer demand,
but development will take time as new containers are produced and tested for diverse foods with
different properties.121
Legislative Proposals
The House-passed bill (§ 87) 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 unsuccessfully to incorporate into the Senate amendment S. 593, the
Ban Poisonous Additives Act of 2009, a bill she sponsored that would ban BPA in all FDA-
regulated food containers. Instead, Senator Feinstein may offer a more limited amendment to
restrict BPA if the amendment to S. 510 is considered by the Senate before the end of the 111th
Congress.122 Although Senator Feinstein has not made a specific alternative proposal public, it is
reported that she may seek a ban on BPA only in children’s food and drink containers and the
linings of infant formula cans.123
Paying for Food Safety with User Fees
How Much Is Needed and Who Should Pay?
Many critics have argued that—irrespective of the need, if any, to reform food safety statutes and
organization—a fundamental problem has been FDA’s stated lack of sufficient funding and staff
to carry out congressionally mandated (and existing) responsibilities to ensure a safe food
supply.124 Responding to a request from Democratic leaders of the House Energy and Commerce

120 Lyndsey Layton, “No BPA for Baby Bottles in U.S.,” The Washington Post, March 6, 2009.
121 Lyndsey Layton, “Replacing BPA in Cans Gives Foodmakers Fits; FDA Safety Concerns Prompt Scramble to
Remove the Chemical,” The Washington Post, February 23, 2010.
122 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.
123 Ellyn Ferguson, “Lobby Is Cooking Up Ways to Put Food Safety Bill on Senate Agenda,” CQ Today, September 17,
2010.
124 See, e.g., FDA Science Board, FDA Science and Mission at Risk: Report of the Subcommittee on Science and
(continued...)
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Committee, a subcommittee of the FDA Science Board125 estimated that, in order to address these
deficiencies, the food-related portion of FDA’s appropriation should be increased.126 In fact,
congressional appropriators have increased funding for FDA food activities in recent years.127
(See Table 5.)
Table 5. 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 compete with other priorities throughout the federal discretionary budget. The
programs do not operate as mandatory authorizations as do farm support programs, for example,
and currently are being made during a period of budget deficits.
An alternative approach to direct appropriations that has been used in some other areas of FDA is
to fill perceived shortfalls through new user fees on the regulated industry. User fees related to
foods have been proposed in legislation and in budget requests over time. The FY2011
President’s budget request proposed $6.467 million for reinspection fees, $4.307 million for
export certification fees, and $182.783 million in inspection and registration fees. To date, no
such user fees for foods have been explicitly authorized.
Currently, FDA’s authority to collect user fees extends to human and animal prescription drugs
and human medical devices (21 U.S.C. 379g - 379j-12);128 human biologics (42 U.S.C. 262 note);
and tobacco products (21 U.S.C. 387s). Some of these user fees are paid annually, and some are
paid when submitting certain applications to FDA. The fees collected are intended to be used to
fund approval-related activities; with the exception of tobacco fees, they can not be used to fund
enforcement or inspection activities for products on the market, except to a very limited extent.
(Unlike foods and some food additives, prescription drugs, medical devices, and animal drugs
require FDA’s advance permission before they can be legally marketed.) The user fee programs

(...continued)
Technology, November 2007.
125 The Science Board is one of several advisory committees to FDA. It consists of experts from academia and industry,
and advises the Commissioner on specific complex and technical issues, as well as emerging issues within the scientific
community, in industry and academia. It also provides advice to the Agency on keeping pace with technical and
scientific evolutions in the fields of regulatory science, formulating appropriate research agendas, and upgrading its
scientific and research facilities to keep pace with these changes. FDA, Science Board to the Food and Drug
Administration
, October 6, 2010, http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/
ScienceBoardtotheFoodandDrugAdministration/default.htm.
126 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.
127 See CRS Report R40792, Food and Drug Administration Appropriations for FY2010.
128 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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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 added to the agency’s budget.
Fees have provided additional resources for the agency to hire reviewers to conduct premarket
reviews; to hire support personnel and field investigators to speed up the application review
process for drugs, biological products, and medical devices; and to acquire and support critical
information technology infrastructure.129
The introduction of fees has also raised the following four issues, among others, which are
applicable to policy discussions about food fees. First, proposals for new user fees typically meet
with resistance, both from the companies that would have to absorb such costs and from
consumer advocates, who argue that industry funds might cause conflicts of interest by having
industry pay the salaries of some of its regulators. (Certain types of fees, such as for facility
registration, have not been as vociferously opposed by some consumer advocates.) To help
address the issues that underlie this resistance, clear conflict-of-interest guidelines as well as
certain restrictions on how funds may be expended have been created in other areas.
Second, concerns are sometimes expressed that user fees, once authorized, comprise an ever-
increasing proportion of the budget, and may supplant rather than supplement funding for the
agency. For that reason, certain fees carry the requirement that direct appropriations meet a certain
threshold before user fees can be collected.130
Third, the funding generated by some types of fees—those that are periodic and associated with
external events such as the submission of marketing applications—can be difficult to predict.
However, FDA’s highly trained staff can not easily be increased or trimmed to conform to short-
term activity levels and associated available funds. One example of the dilemma of unpredictable
fee funding comes from the area of medical device user fees. In FY2002, when they were initially
authorized, the fees were all periodic, which led to unpredictable funding for the device program
and caused some budgetary shortfalls.131 In FY2007, in order to make user fee funding more
consistent and reliable, certain annual fees (such as annual registration fees) were enacted to help
resolve the issue.132

129 For an example regarding drugs, see U.S. Congress, House Committee on Energy and Commerce, Subcommittee on
Health, Prepared Statement of Hon. Lester M. Crawford, Deputy Commissioner, Food and Drug Administration,
Reauthorization of the prescription Drug User Fee Act, 107th Cong., 2nd sess., March 6, 2002, f:78503.wais
(Washington: GPO, 2002), pp. 30-31.
130 See CRS Report RL34334, The Food and Drug Administration: Budget and Statutory History, FY1980-FY2007.
131 See Barbara Zimmerman, Medical Device Review Program Performance, FDA, Webcast, 2010,
http://www.fda.gov/downloads/MedicalDevices/NewsEvents/WorkshopsConferences/UCM224256.wmv.
132 Id., and see CRS Report RL34571, Medical Device User Fees and User Fee Acts; and CRS Report RL34465, FDA
Amendments Act of 2007 (P.L. 110-85)
.
Congressional Research Service
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Food Safety in the 111th Congress: H.R. 2749 and S. 510

A fourth set of concerns has been raised by small businesses. In the area of drugs and devices,
small businesses claim to be drivers of innovation, and caution that fees imposed on them have a
disproportionate and chilling effect on their work. For that reason, many of the drug- and device-
related user fees have reductions for small businesses.
Legislative Proposals
Each proposal would fund some FDA food safety activities through the collection of user fees,
though the types of fees and details differ. (See Table 6.) The House-passed bill would establish
two annual fees (a facility registration fee and an importer registration fee), and two fees related
to periodic activities (a reinspection and recall fee, and an export certification fee). The Senate
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 Table 7 and Table 8, including,
where specified, who pays the fee, the fee amount, restrictions on the fee amount, the result of
nonpayment, how funds may be used, required reports and meetings, authorizations,
appropriations-related restrictions on fee collection, and expiration dates. For fees paid annually,
see Table 7. For periodic fees, see Table 8.
Table 6. 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
§ 53
None
Importer Registration Fee
§ 204
None
Reinspection Fee
§ 64
§ 64
Recall Fee
§ 64 (for all recalls)
§ 107 (for noncompliance with recall)
Export Certification Fee
§ 643
§ 64
VQIP Fee
None
§ 64
Source: Prepared by the CRS based on the text of the House-passed H.R. 2749 and Senate manager’s
amendment to S. 510.
The House-passed bill would authorize higher fees, would carry a higher total price tag, and
would mandate more frequent inspections than the Senate 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.133 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.134

133 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.
134 Note that the CBO scores in this paragraph are specific to FDA costs. For that reason, they are somewhat lower than
amounts discussed earlier this report, which reflect estimated total federal costs.
Congressional Research Service
44

Food Safety in the 111th Congress: H.R. 2749 and S. 510

Note that the Tester Amendment to S. 510 (discussed in the “Mitigating Effects on Small
Business and Farming Operations” section) might reduce the number of businesses required to
register under FFDCA §415. While any such reduction would not reduce the amount of fees
collected under S. 510 (which has no registration fee), it would reduce the fees collected under
H.R. 2749 (which has a registration fee). Thus, if S. 510 were amended by the Tester Amendment
and passed the Senate, the issue of which facilities must register and whether and how many fees
would be collected would remain to be reconciled between the House and Senate, and could
affect the CBO score of the resulting legislation.
Congressional Research Service
45

Food Safety in the 111th Congress: H.R. 2749 and S. 510

Table 7. 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
VQIP Fee
Who Pays
Facilities required to register under
Importers required to register under new
Importers participating in the voluntary importer certification
amended FFDCA § 415.
FFDCA § 801(s).
program, under new FFDCA § 806.
Fee Amount
$500/facility (inflation adjusted annually).
$500/importer (inflation adjusted 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.
CRS-46

Food Safety in the 111th Congress: H.R. 2749 and S. 510

Table 8. 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
Category
Reinspection and Recall
Fee
Export Certification Fee
Reinspection Fee
Recall Fee
Export Certification
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.
CRS-47

Food Safety in the 111th Congress: H.R. 2749 and S. 510

H.R. 2749, House-passed
S. 510, Manager’s Amendment
Category
Reinspection and Recall
Fee
Export Certification Fee
Reinspection Fee
Recall Fee
Export Certification
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.
CRS-48

Food Safety in the 111th Congress: H.R. 2749 and S. 510

Appendix A. Snapshot of Provisions According to Sections of House-passed H.R.
2749 and the S. 510 Amendment (ranked by section number)

Subject Matter
H.R. 2749 (House-passed)
S. 510 (Amendment)
PROVISIONS ACCORDING TO SECTIONS OF H.R. 2749, IN NUMERICAL ORDER
52
Rules of Construction (§ 4); USDA Exemptions (§ 5); Alcohol-
Jurisdiction; Authorities (§ 403); Alcohol-Related Facilities (§
Related Facilities (§ 6); Extraterritorial Jurisdiction (§ 213)
116); Compliance With International Agreements (§ 404)
53
Changes in Registration of Food Facilities (§ 101)
Registration of Food Facilities (§ 102)
54
Hazard Analysis, Risk-Based Preventive Controls, Food Safety
Hazard Analysis and Risk-Based Preventive Controls (§ 103)
Plan, Finished Product Test Results from Category 1 Facilities (§
102)
56
Performance Standards (§ 103)
Performance Standards (§ 104)
57
Safety Standards for Produce and Certain Other Raw
Standards for Produce Safety (§ 105)
Agricultural Commodities (§ 104)
59
Risk-Based Inspection Schedule (§ 105)
Targeting of Inspection Resources for Domestic Facilities,
Foreign Facilities, and Ports of Entry; Annual Report (§ 201)
61
Access to Records (§ 106). See also the records provisions in
Inspections of Records (§ 101). See also “Enhancing Tracking and
“Traceability of Food,” § 107, and “Registration for Customs
Tracing of Food and Recordkeeping,” § 204
Brokers,” § 205
62
Traceability of Food (§ 107); Unique identification number for
Enhancing Tracking and Tracing of Food and Recordkeeping (§
food facilities, importers, and custom brokers (§ 206)
204)
64
Changes in Registration of Food Facilities (§ 101); Reinspection
Authority to Collect Fees (§ 107); Funding for Food Safety (§
and Food Recall Fees Applicable to Facilities (§ 108); Exportation
401)
Certificate Program (§ 203); Registration for Commercial
Importers of Food; Fee (§ 204)
66
Certification and Accreditation (§ 109, part)
Accreditation of Third-Party Auditors (§ 307)
69
Testing by Accredited Laboratories (§ 110)
Recognition of Laboratory Accreditation for Analyses of Foods
(§ 202)
70
Notification, Nondistribution, and Recal of Adulterated or
Mandatory Recal Authority (§ 206)
Misbranded Food (§ 111)
72
Reportable Food Registry: Exchange of Information (§ 112)
Improving the Reportable Food Registry (§ 211)
73
Safe and Secure Food Importation Program (§ 113)
Voluntary Qualified Importer Program (§ 302)
CRS-49

Food Safety in the 111th Congress: H.R. 2749 and S. 510

Subject Matter
H.R. 2749 (House-passed)
S. 510 (Amendment)
74
Infant Formula (§ 114)
No comparable provision.
75
Surveillance (§ 121)
Surveillance (§ 205)
Public Education and Advisory System (§ 122)
75
Research (§ 123)
Food Safety Integrated Centers of Excel ence (§ 210)
76
Procedures for Seizure (§ 131)
No comparable provision.
76
Administrative Detention (§ 132)
Administrative Detention of Food (§ 207)
77
Authority to Prohibit or Restrict the Movement of Food (§ 133) No comparable provision.
77
Criminal Penalties (§ 134)
No comparable provision.
78
Civil Penalties for Violations Relating to Foods (§ 135)
No comparable provision.
78 (See also 80 below.)
Improper Import Entry Filings (§ 136)
No comparable provision.
79
Food Substances General y Recognized As Safe (§ 201)
No comparable provision.
79
Country of Origin Labeling (§ 202)
No comparable provision.
80
Exportation Certificate Program (§ 203)
Authority to Collect Fees (§ 107)
80
Registration for Commercial Importers of Food; Fee (§ 204);
Foreign Supplier Verification Program (§ 301)
Registration for Customs Brokers (§ 205); Unique Identification

Number for Food Facilities, Importers and Customs Brokers (§

206); Improper Import Entry Filings (§ 136)
81
Prohibition Against Delaying, Limiting, or Refusing Inspection (§
Inspection of Foreign Food Facilities (§ 306)
207); Risk-Based Inspection Schedule (§ 105, part); Certification
and Accreditation (§ 109, part)
83
Dedicated Foreign Inspectorate (§ 208)
Foreign Offices of the Food and Drug Administration (§ 308)
83
Plan and Review of Continued Operation of Field Laboratories (§ Integrated Consortium of Laboratory Networks (§ 203)
209)
84
False or Misleading Reporting to FDA (§ 210)
No comparable provision.
84
Subpoena Authority (§ 211)
No comparable provision.
84
Whistleblower Protections (§ 212)
Employee Protections (§ 402)
See 52 row of Appendix B for § 213 of H.R. 2749 regarding extraterritorial jurisdiction.
85
Support for Training Institutes (§ 214)
Improving the Training of State, Local, Territorial, and Tribal
Food Safety Officials (§ 209); Enhancing Food Safety (§ 210)
CRS-50

Food Safety in the 111th Congress: H.R. 2749 and S. 510

Subject Matter
H.R. 2749 (House-passed)
S. 510 (Amendment)
87
Bisphenol A in Food and Beverage Containers (§ 215)
No comparable provision.
87
Lead Content Labeling Requirement for Ceramic Tableware and
No comparable provision.
Cookware (§ 216)
PROVISIONS ACCORDING TO SECTIONS IN S. 510 THAT HAVE NOT ALREADY BEEN LISTED, IN NUMERICAL ORDER
87
Hazard Analysis, Risk-Based Preventive Controls, Food Safety
Protection Against Intentional Adulteration (§ 106); National
Plan, Finished Product Test Results from Category 1 Facilities (§
Agriculture and Food Defense Strategy (§ 108); Food and
102)
Agriculture Coordinating Councils (§ 109); Building Domestic
Capacity (§ 110)
90
No comparable provision.
Sanitary Transportation of Food (§ 111)
90
No comparable provision.
Food Al ergy and Anaphylaxis Management (§ 112)
92
No comparable provision.
New Dietary Ingredients (§ 113)
92
No comparable provisions.
Requirements for Guidance Relating to Post Harvest Processing
of Raw Oysters (§ 114); Updating Guidance Relating to Fish and
Fisheries Products Hazards and Controls (§103, part)
93
No comparable provision.
Port Shopping (§ 115)
See 52 row of Appendix B for § 116 of S. 510 regarding alcohol.
93
No comparable provision.
Decontamination and Disposal Standards and Plans (§ 208)
94
Certification and Accreditation (§ 109, part)
Authority to Require Import Certifications for Food (§ 303)
95
No comparable provision.
Prior Notice of Imported Food Shipments (§ 304)
96
No comparable provision.
Building Capacity of Foreign Governments with Respect to Food
(§ 305)
96
No comparable provision.
Smuggled Food (§ 309)
Source: Table created by CRS staff based on the text of the House-passed H.R. 2749 and the S. 510 Amendment. Provisions are listed in numerical order by
section number, beginning with sections in H.R. 2749, followed by sections in S. 510 not yet presented.

CRS-51

Food Safety in the 111th Congress: H.R. 2749 and S. 510

Appendix B. Comparison of Current Law with Provisions in House-passed H.R.
2749 and the S. 510 Amendment

Background, Applicable Current Law, and
Administration Statements
H.R. 2749 (House-passed)
S. 510 (Amendment)
PROVISIONS ACCORDING TO SECTIONS OF H.R. 2749, IN NUMERICAL ORDER
JURISDICTION
The preemption doctrine is derived from the Supremacy
Rules of Construction (§ 4)
Jurisdiction; Authorities (§ 403)
Clause of the U.S. Constitution, which establishes that the
laws of the United States “shall be the supreme law of the
The preemption provision states that “Nothing in this Act or
Not a preemption provision; provides that this Act, and any
land; and the judges in every state shal be bound thereby,
the Amendments made by this Act shal be construed to
amendment made by it, would not: (1) alter jurisdiction
any thing in the Constitution or laws of any State to the
prohibit or limit—(1) any cause of action under State law; or
between HHS and USDA under applicable statutes,
contrary notwithstanding." In general terms, federal
(2) the introduction or evidence of compliance or
regulations, or agreements regarding products eligible for
preemption occurs when a validly enacted federal law
noncompliance with” the FFDCA.
voluntary inspection under the Agricultural Marketing Act (7
supersedes any inconsistent state law. Courts’ application of
U.S.C. 1621 et seq.); (2) alter the jurisdiction between the
Also clarifies that nothing in this Act is to limit or otherwise
this may involve such factors as whether or not a federal
Administration of the Alcohol and Tobacco Tax and Trade
alter the current jurisdiction or authorities between the
statute has explicitly stated Congress’ intent on the matter.
Bureau and the HHS Secretary; (3) limit the authority of the
Secretaries of HHS and of Agriculture, including those under
This issue is discussed regarding medical devices in CRS
HHS or Agriculture Secretary under specified existing
the FFDCA, Public Health Service Act, the Federal Meat
Report R40534, Riegel v. Medtronic, Inc.: Federal Preemption of
statutes (including the FFDCA); or (4) impede, minimize, or
Inspection Act (FMIA), the PPIA, or the Egg Products
State Tort Law Regarding Medical Devices with FDA Premarket
affect the authority of the Secretary of Homeland Security
Inspection Act (EPIA).
Approval.
under the Homeland Security Act (6 U.S.C. 101 et seq.).
USDA Exemptions (§ 5)
Separately, FFDCA § 902(b) general y exempts meat and

meat food products from the provisions of the FFDCA; § 24
Explicitly exempts from this Act foods and establishments to
of the Poultry Products Inspection Act (PPIA) general y
the extent that they are regulated under the FMIA, PPIA, or
exempts poultry and poultry products from FFDCA
EPIA. Exempts a farm “to the extent such farm raises animals
provisions.
from which” such foods are derived. Clarifies that livestock
and poultry intended for slaughter under the FMIA, PPIA, as
well as milk-producing cows, sheep, or goats are exempt.
Alcohol
Alcohol-Related Facilities (§ 6)
Alcohol-Related Facilities (§ 116)
The Federal Alcohol Administration Act (27 U.S.C. 201 et
Similar to the Senate provision, except that it contains a
General y exempts from this Act (the Manager’s Amdt.)
seq.) provides for regulation of those engaged in the alcohol
shorter list of provisions excepted from the exemption.
beverages and facilities that are primarily regulated under the
beverage industry, and for the protection of consumers.
Notably, mandatory recal and administrative detention
Alcohol Administration Act. Certain of the act’s provisions
provisions are not excepted from the exemption. Therefore,
are excepted from this exemption, including those related to
they would not apply to alcohol-related beverages and
registration, mandatory recall, and administrative detention,
facilities.
among others; these provisions would apply to alcohol-
related beverages and facilities.
Extraterritorial Jurisdiction (§ 213)
CRS-52

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 (Amendment)
Makes the following a prohibited act under the FFDCA: “The
Compliance With International Agreements (§ 404)
production, manufacture, processing, preparation, packaging,
holding, or distribution of an adulterated or misbranded food
Nothing in this Act shall be construed in a manner
with the knowledge or intent that such article will be
inconsistent with the agreement establishing the World
imported into the United States.”
Trade Organization or any other agreement or treaty to
which the United States is a party.
Adds a new § 312 to the FFDCA stating that “There is
extraterritorial Federal jurisdiction over any violation of this
Act relating to any food if such article was intended for
import into the United States or if any act in furtherance of
the violation was committed in the United States.”
FOOD FACILITY REGISTRATION REQUIREMENTS (See also “Registration”, “Mitigating Effects on Small Business and Farming Operations” and “Paying for Food Safety with User
Fees” sections of this report.)
Some assert that registration requirements should be
Changes in Registration of Food Facilities (§ 101)
Registration of Food Facilities (§ 102)
strengthened so that FDA is notified when a firm moves,
undertakes a new food business, or changes product lines.
Amends FFDCA § 415 both to require facilities to register
Amends FFDCA § 415 to require biennial facility registration,
Otherwise, the FDA’s records on what facilities are
annual y, by each December 31, and to pay an annual
with an abbreviated process for registrants whose
manufacturing and marketing food are continual y out of date, registration fee of $500. The Secretary is authorized to
information has not changed. Registrants are required to
it is argued. Others have argued that additional registration
suspend the registration of any facility for an FFDCA violation provide additional contact information, including an e-mail
requirements would be needlessly intrusive and costly for the that could result in serious adverse health consequences or
address and, for foreign facilities, the United States agent for
industry.
death to humans or animals. Where the Secretary exercises
the facility. Registrants must also provide an assurance that
this discretionary suspension authority, the Secretary must
the Secretary will be permitted to inspect the facility. The
Both domestic and foreign food facilities are required to
first provide the facility a notice of intent and opportunity for
Secretary is authorized or required to suspend and/or
register with FDA pursuant to FFDCA § 415. Farms,
an informal hearing, after which a suspension order may be
reinstate registrations, based on the Secretary’s
restaurants, other retail food establishments, and most
written for finding a violation, with timelines for doing so
determination that “food manufactured, processed, packed,
nonprofit food establishments and fishing vessels are
specified. A suspended registration could be reinstated based
or held by a facility registered under this section has a
excluded from the requirement. Renewal is not required on
on criteria published by the Secretary. Places limitations on
reasonable probability of causing serious adverse health
any periodic basis, but registrants must notify the Secretary in the Secretary’s authority to delegate suspension decisions.
consequences or death to humans or animals” for a facility
a timely manner of any relevant changes in their status.
that “created, caused, or was otherwise responsible” or “that
FFDCA § 301(dd) designates failure to register as a
Makes failure to register an act of “misbranding” under
knew of, or had reason to know of, such reasonable
prohibited act. FFDCA § 801(l) provides that imported food
FFDCA § 403.
probability.” The bill delineates an appeal process, including a
may not be delivered to the importer, owner, or consignee
Also amends the information requirements of registrants to
requirement for an informal hearing generally within two
of the article until the foreign facility is registered. FDA does
include: the name, address, and emergency contact of each
business days, and procedures for submission of a corrective
not have explicit authority to require a registration fee.
facility being registered; its primary purpose and business
action plan and for lifting a suspension. The Secretary shall
review corrective action plans “not later than 14 days after
Obama Administration: The Hamburg and Taylor
activity, including dates of operation if seasonal; the category
the submission” of such plans. The Secretary also shal
testimonies express support for § 101 of the House bill.
of food manufactured, processed, packed or held there; al
business trade names; and the name, address and 24-hour
promulgate regulations regarding suspension and
emergency contact information of the U.S. distribution agent.
reinstatement procedures. If its registration is suspended, a
Further requires registrants to notify the Secretary of any
facility may not import food, or introduce food into
changes in products, function or legal status within 30 days of interstate or intrastate commerce, in the United States. The
Secretary’s authority to suspend registration shall not be
CRS-53

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 (Amendment)
a change, unless otherwise specified by the Secretary, who
delegated to anyone other than the FDA Commissioner. The
may cancel a registration that is improperly updated or
Secretary may require that registration be submitted
contains false, misleading, or inaccurate information, or if the
electronical y, but not earlier than 5 years after enactment.
required fee is not paid within 30 days.
Contains provisions for consideration of smal businesses.
Contains extensive language defining what is and is not a
Requires the Secretary to issue a ”small entity compliance
facility. A facility is “any factory, warehouse, or establishment
policy guide” setting forth the requirements of such
(including a factory, warehouse or establishment of an
regulations to assist small entities in complying with the
importer) that manufactures, processes, packs or holds
registration requirements and other activities (no later than
food.” Stipulates that a facility is not a farm, a private
180 days after the issuance of the regulations under this
residence, a restaurant or other retail food establishment, a
section).
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.
See also “Funding and Fees” and “Foreign Supplier
Verification” below regarding importer registration
requirements and fees.
HAZARD PREVENTION PLANS (See also “Hazard Analysis and Risk-Based Preventive Controls”, “Mitigating Effects on Small Business and Farming Operations”, and “Mandatory Recall
Authority” sections of this report.)
A broad consensus of policymakers agrees that FDA’s system Hazard Analysis, Risk-Based Preventive Controls,
Hazard Analysis and Risk-Based Preventive Controls
of safeguards, which is based on a law first written early the
Food Safety Plan, Finished Product Test Results from (§ 103)
last century, is primarily reactive. By and large, the agency's
Category 1 Facilities (§ 102)
statute and regulations spell out the reasons a food article is
Establishes a new FFDCA § 418, requiring the owner,
to be considered adulterated or misbranded and therefore
Establishes a new FFDCA § 418, with provisions broadly
operator, or agent in charge of a facility to develop a written
unfit for consumption. In effect, industry players are expected similar to those in S. 510, but differing somewhat in detail and plan and carry out certain preventive activities in the plan,
to abide by the rules; generally it is only when a problem is
organization. Like S. 510, requires the owner, operator, or
including:
detected—often after an illness outbreak is reported or
agent of a facility to analyze hazards and implement controls
• conducting an analysis to identify and evaluate known or
testing finds a contaminant in a product—that officials step in
to prevent or reduce them, but unlike S. 510, requires a food reasonably foreseeable hazards that may be associated with
to correct it, or order the industry to do. So virtually all
safety plan to be developed and implemented before a facility
the facility, hazards that may be intentionally introduced,
stakeholders, including regulators, the regulated industries,
introduces or delivers for introduction into interstate
including by acts of terrorism; and preparing a written
consumer advocates, and food safety scientists now agree
commerce any shipment of food.
analysis;
that the foundations of any new program should be an
Requires (under § 418A) that this plan include a hazard
understanding of what, and how, hazards can enter the food
analysis to identify whether there are hazards, including those • identifying and implementing preventive controls, including
supply, fol owed by implementation of measures to prevent
due to the source of ingredients, that are reasonably likely to
at critical control points, if any, to provide assurances that
these hazards.
occur in the absence of preventive controls. The plan also
identified hazards will be prevented or minimized, and that
food is not adulterated or misbranded;
FDA currently requires that managers of certain food
must include descriptions of:
facilities—those producing or processing seafood, some
• preventive controls being implemented including those to
• developing a means to verify the effectiveness of these
juices, and low-acid canned foods—prepare Hazard Analysis
address hazards identified by the Secretary;
preventive controls;
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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 (Amendment)
and Critical Control Point (HACCP) plans for their
• procedures for monitoring preventive controls;
• implementing corrective actions if controls are found,
operations. HACCP is a preventive approach that
through monitoring, not to have been effective (specifies that
incorporates hazard analysis, appropriate process controls,
• procedures for taking corrective actions;
corrective actions ensure “(1) appropriate action is taken to
verification, and other steps throughout the production
• verification activities including validation that such controls reduce the likelihood of recurrence of the implementation
process. A cornerstone of HACCP is the identification of
are effective (to include use of environmental and product
failure; (2) all affected food is evaluated for safety; and (3) all
hazards by industry that are “reasonably likely to occur.” The testing programs);
affected food is prevented from entering into commerce if
emphasis on hazards that are reasonably likely to occur
the owner, operator or agent in charge of such facility cannot
assures that such hazards—such as microbial contamination
• monitoring of such preventive controls to verify
ensure that the affected food is not adulterated,” as defined
in fresh juices, or botulism in low-acid canned foods—are
effectiveness;
by law)
systematically and consistently addressed.
• record keeping procedures (records must be kept for at
• verifying that preventive controls are effective, that
There is no explicit statutory authority or requirement
least two years);
monitoring is ongoing, that corrective actions are taken when
regarding HACCP systems for FDA-regulated foods. FDA
needed, and that the plan is periodically reviewed for
regulations requiring HACCP plans and systems for seafood,
• both established recall procedures and traceback
continued relevance;
fruit and vegetable juices, and low-acid canned foods cite the
procedures;
applicable statutory authority as FFDCA § 402(a), which
• procedures to ensure the safety of the supply chain for
• keeping and maintaining, for at least two years, records
defines adulteration, and the Secretary’s general authority to
ingredients;
documenting the monitoring of preventive controls, relevant
promulgate regulations to assure the safety of foods, at
instances of nonconformance, instances when corrective
FFDCA § 701(a).
• procedures to implement performance standards issued
actions were implemented, and the efficacy of preventive
by the Secretary (under a new FFDCA § 419).
controls and corrective actions.
At the U.S. Department of Agriculture, the Food Safety and
Inspection Service (FSIS) in 1996 began implementing rules to
The owner, operator, or agent must conduct a reanalysis of
Applicable definitions are provided in this section for “critical
establish a mandatory HACCP for meat and poultry, using its
hazards (and revise preventive controls if necessary): (1) at
control point,” “facility,” and “preventive controls.” The
authority to regulate major meat and poultry species under
least every two years (S. 510 is every three years); (2) if
required plan and associated documentation of performance
the Federal Meat Inspection Act (FMIA) and Poultry Products there is a change in the process or product that could affect
must be made promptly available to an authorized
Inspection Act (PPIA). Record keeping and verification are
the hazard analysis; and (3) if the Secretary determines it is
representative of the Secretary upon oral or written request.
used to ensure that the system is working. Following a phase-
appropriate to protect public health. Limits the Secretary’s
The hazards must be reanalyzed at least every three years, or
in period to accommodate smaller sized establishments, and
ability to delegate the authority to order revisions. Contains
sooner if there is a change in processes or practices that
since January 2000, al slaughter and processing operations
applicable definitions (including one not in S. 510 defining
could create or worsen a hazard. The Secretary may require
have been required to have HACCP plans in place. HACCP is “hazard that is reasonably likely to occur”), the same deemed a revision of the plan based on a new hazard or new scientific
intended to operate as an adjunct to the traditional methods
compliance for seafood, juice, and low-acid canning facilities,
information, including, as appropriate, “results from the
of facility inspection, which still are mandatory under the
and the same effective dates based on business size as in S.
Department of Homeland Security biological, chemical,
original statutes.
510.
radiological, or other terrorism risk assessment.” Failure to
comply with the requirements of this section is prohibited
Obama Administration: The Administration's Food Safety
Also as is similar in S. 510, the Secretary is required to issue
under FFDCA § 301.
Working Group (FSWG) stated that the Administration would
guidance or regulations on standards for conducting a hazard
work with Congress on “critical legislation that will provide key
analysis and establishing preventive controls. However, the
Seafood, juice, and low-acid canned-food facilities that are
tools .... to keep food safe.” One tool it cited was the ability to
Secretary must allow the facility to implement an alternative
already in compliance with applicable FDA regulations are
require sanitation and preventive controls at food facilities, based preventive control if it is able to demonstrate that it
deemed to be in compliance with this section. Facilities
on a scientific hazard analysis. The Hamburg and Taylor
effectively addresses the hazard. Food from facilities not in
subject to requirements in FFDCA § 419, as established by
testimonies express support for § 102 of the House bill.
compliance with these provisions are to be considered
this act (regarding safety standards for produce), are not
adulterated under the FFDCA.
subject to this section. The Secretary may, by regulation,
exempt or modify the requirements of this section for
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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 (Amendment)
In issuing guidance or regulations, the Secretary must, to seek facilities that are solely engaged in the production of food for
consistency, review relevant international standards for
animals other than man, the storage of raw agricultural
hazard analysis and preventive controls. The Secretary also
commodities (other than fruits and vegetables) intended for
must consider their impact on small businesses and must
further distribution or processing, or the storage of packaged
issue guidance to assist smal businesses in complying.
foods that are not exposed to the environment. This section
does not limit the Secretary’s authority to revise, issue or
The Secretary is authorized to exempt from or modify, by
enforce regulations for specific types of foods, such as the
regulation, the requirements with respect to facilities engaged HACCP regulations currently in effect for certain foods. This
solely in the production of food for nonhumans (and may
section does not apply to dietary supplements.
take into account differences between human and animal
foods), facilities that store packaged foods not exposed to
Considering existing regulatory hazard analysis and
the environment, or facilities that store raw agricultural
preventive control programs to determine applicable
commodities for further distribution or processing.
internationally recognized standards, the Secretary shall
promulgate regulations not later than 18 months after
Further, under a new FFDCA § 418B, the Secretary must
enactment regarding the implementation of requirements
require submission of finished product test results by the
under this section, and shall issue an applicable guidance
owner, operator, or agent of each category 1 facility (see
document. Regulations shall be sufficiently flexible to be
“Risk-Based Inspection Schedule,” below, for definition of
applicable in all situations, including the operations of small
such facility) “...documenting the presence of contaminants in
businesses. This section does not provide the Secretary with
food in the possession or control of such facility posing a risk
the authority to apply specific technologies, practices, or
of severe adverse health consequences or death.” Such
critical controls to an individual facility.
submissions are those determined by the Secretary to be
feasible and appropriate and taking into consideration
Contains clarifying language regarding the promulgation of
available information on potential risks; and this section is not FDA regulations, including consideration for various types of
to: construe a requirement for mandated “testing or
businesses and activities (on-farm and at processing facilities).
submission of test results that the Secretary determines
Contains provisions for consideration of smal businesses.
would not provide useful information in assessing the
Requires the Secretary to issue a ”small entity compliance
potential risk presented by a facility or product category”; or
policy guide” setting forth the requirements of such
to limit the Secretary’s authority under other provisions to
regulations to assist small entities in complying with the
access information or test results including in the course of
registration requirements and other activities (no later than
an investigation of an illness or contamination incident.
180 days after the issuance of the regulations under this
section), along with other flexibility and extended
This requirement is to take effect on the sooner of either 2
implementation deadlines for smal and very smal businesses.
years from date of enactment or the completion of a
Requirements become effective in stages according to the
feasibility study and at least two pilot projects that are
size of the business: businesses must be compliant 18 months
required. Food from a facility not in compliance with the
after the date of enactment, except smal businesses (as
requirements of new § 418B is adulterated.
defined by the Secretary) are to have 2 years after
enactment, and very smal businesses (as defined by the
Secretary) 3 years after enactment.
PERFORMANCE STANDARDS (See also “Performance Standards” section of this report.)
Performance standards are typically specific, quantitative
Performance Standards (§ 103)
Performance Standards (§ 104)
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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 (Amendment)
measurements of a property of, or a substance in, food. They
Similar in intent but not identical to S. 510. Under a new
In coordination with USDA, the Secretary shall, at least every
may apply strictly to the property being measured, or serve
FFDCA § 419, the Secretary must at least every two years
two years, review and evaluate relevant health data and other
as benchmarks for whether the food is safe in a broader
review and evaluate epidemiological data and other
relevant information, including epidemiological and
sense. For example, a performance standard for a single
appropriate information, including research under § 123 (the
toxicological data and other appropriate information to
microbe might be used to determine whether a product is
research section) of the bill, to identify the most significant
determine the most significant foodborne contaminants.
contaminated with microbes in general. (This approach is
food-borne contaminants and resulting hazards. Following
sometimes cal ed process verification.) Such a finding could
each review, the Secretary must publish in the Federal
Based on such review and evaluation and when appropriate
indicate a problem with the product’s processing, and
Register a list of contaminants that have the greatest adverse
to reduce the risk of serious illness or death to humans or
prompt a review of processing activities. The FFDCA (in
impact on public health (and must consider the number and
animals, or to prevent the adulteration of the food under
various provisions in Chapter IV, regarding food) authorizes
severity of illnesses and deaths associated with the
FFDCA § 402 or the spread of communicable disease under
FDA to promulgate standards for certain hazards, such as
contaminant in a food).
PHS Act § 361, the Secretary shall issue contaminant-specific
maximum permissible levels (called tolerances) for residues
and science-based guidance documents, actions levels, or
of pesticides or drugs in foods. The FFDCA does not grant
The Secretary must issue, “as soon as practicable” through
regulations. Such standards shall apply to products and
FDA the explicit authority to develop standards solely as a
guidance or by regulation, science-based performance
product classes, may differentiate between food for humans
means to verify that processing is carried out in a manner
standards (which may include action levels) to significantly
and food for animals, and shall not be written to be facility-
that assures the safety of the food.
minimize, prevent, or eliminate such hazards. The standards
specific. HHS shall coordinate with USDA to avoid
shal apply to foods and food classes. Foods not meeting
duplication of effort regarding guidance documents for the
Obama Administration: The FSWG stated that the
required standards are to be considered adulterated. The
same contaminant. The Secretary will issue and periodically
Administration would work with Congress on “critical
Secretary is authorized to make recommendations to
review/revise all guidance documents and regulation.
legislation that will provide key tools .... to keep food safe.”
industry on product sampling. Finally, the Secretary must
One tool it cited was the ability to establish performance
report to Congress on the review including how the

standards to measure the implementation of proper food
Secretary will address significant hazards and any resource or
safety standards. The Hamburg and Taylor testimonies
data limitations that preclude further action.
express support for § 103 of the House bill.
PRODUCE SAFETY STANDARDS (See also “On-Farm Safety Standards; Safety of Produce” and “Mitigating Effects on Small Business and Farming Operations” sections of this report.)
As noted earlier, the FFDCA authorizes FDA to promulgate
Safety Standards for Produce and Certain Other Raw Standards for Produce Safety (§ 105)
standards for certain hazards, some of which, such as
Agricultural Commodities (§ 104)
maximum permissible levels (called tolerances) for residues
Subsection (a) of this section establishes a new FFDCA § 419,
of pesticides, may apply to produce. The FFDCA does not
Under a new FFDCA § 419A, within 18 months of
regarding safety standards for produce. Within one year of
grant FDA explicit authority to develop standards solely as a
enactment, the Secretary (in coordination with the Secretary
enactment, the Secretary (in consultation with USDA and
means to verify that processing is carried out in a manner
of Agriculture) must publish a notice of proposed rulemaking, state agriculture departments, including with regard to the
that assures the safety of the food. FDA has several voluntary and within three years after such date, final rules establishing
national organic foods program, and in consultation with
efforts in place to address safety in the produce industry. For
scientific and risk-based standards for the safe growing,
DHS), is required to publish a notice of proposed rulemaking
example, in February 2008, the agency issued the final version harvesting, processing, packing, sorting, transporting, and
for science-based minimum standards for the safe production
of the Guide to Minimize Microbial Food Safety Hazards of
holding of those types of raw agricultural commodities that
and harvesting of those fruits and vegetables that are raw
Fresh-cut Fruits and Vegetables, which contains non-binding
are from a fruit, vegetable, nut, or fungus, and for which the
agricultural commodities (including mixes and specific
recommendations regarding: primary production and
Secretary has determined such standards are reasonably
categories of fruits and vegetables), for which the Secretary
harvesting of fresh fruits and vegetables; personnel; buildings
necessary to minimize the risk of serious adverse health
has determined that such standards minimize the risk of
and equipment; sanitation operations; production and
consequences or death to humans or animals
serious adverse health consequences or death. The Secretary
process controls; documentation and records; traceback; and
may exclude from such rulemaking commodities determined
These regulations may set forth procedures and practices
to be low risk when produced or harvested by small or very
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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 (Amendment)
recall. On September 2, 2008, FDA published a notice in the
that the Secretary determines reasonable to prevent known
small businesses. The Secretary shall hold at least 3 public
Federal Register seeking comments and data to assist the
or reasonably foreseeable biological, chemical, and physical
meetings on such rulemaking in diverse geographic areas.
agency in its revision, now underway, of its 1998 Guide to
hazards, including natural ones, that may be intentionally or
Minimize Microbial Food Safety Hazards for Fresh Fruits and
unintentionally introduced. The regulations may include
Proposed rulemaking shall “provide sufficient flexibility to be
Vegetables. Also, FDA asserts that it has been engaged in
minimum safety standards, and address manure use, water
applicable to various types of entities…including small
efforts to identify hazards commonly associated with fresh
quality, employee hygiene, sanitation and animal control, and
businesses and entities that sel directly to consumers, and be
produce, and to develop tracking and tracing methods.
temperature controls, as the Secretary determines to be
appropriate to the scale and diversity” of production and
reasonably necessary. They may provide for coordination of
harvesting. The proposed rule also shal address minimum
Under the Agricultural Marketing Agreement Act of 1937 (7
education and enforcement activities and must provide a
standards for other specified elements, including soil
U.S.C. § 601 et seq.), producers and handlers can organize
reasonable time for compliance, taking into account the
amendments, hygiene, packaging, temperature controls,
themselves under legally binding marketing orders that can
needs of smal businesses for additional time, among other
animal encroachment and water, as well as hazards that
include quality (and possibly, safety) standards. The act is
permitted activities. The Secretary is required to take into
occur naturally or that may have been introduced,
overseen by USDA’s Agricultural Marketing Service (AMS). In consideration (consistent with public health) “the impact on
intentionally or unintentionally. The proposal shall take into
an advance notice of proposed rulemaking, AMS in October
small-scale and diversified farms, and on wildlife habitat,
consideration, consistent with public health protection,
2007 invited comments on whether to create such a federal
conservation practices, watershed-protection efforts, and
“conservation and environmental practice standards and
marketing program that specifical y would require handlers
organic production methods.” The Secretary shal coordinate
policies established by Federal natural resource conservation,
(packers, processors, shippers) of leafy greens, including
with the Secretary of Agriculture and may contract and
wildlife conservation, and environmental agencies,” and also
lettuce and spinach, to meet prescribed safety standards. A
coordinate with a Governor-designated state agency for
“in the case of production that is certified organic, not
similar state order was adopted by California growers in
education and compliance activities (emphasis added to
include any requirements that conflict with or duplicate the
2006.
distinguish from S. 510, which mandates use of state
requirements of” the national organic foods program, while
providing the same level of protection as required under this
Obama Administration: The FSWG announced, and FDA
agencies).
act. Priority is to be given to those raw fruits and vegetables
issued on July 31, 2009, new draft guidances on three specific
Under this new provision, a food is adulterated if it is grown,
that have been associated with food-borne illness outbreaks.
types of produce: Guide to Minimize Microbial Food Safety
harvested, packed, sorted, transported or held under
Hazards of Tomatoes, Guide to Minimize Microbial Food
conditions that do not meet these new requirements. The bill Subsection (b) states that within a year of the closing of the
Safety Hazards of Melons, and Guide to Minimize Microbial
appears to lack the variance procedures, and the express
comment period, the Secretary shall adopt a final rule to
Food Safety Hazards of Leafy Greens, which, when finalized
exemption for those required to meet hazard analysis and
provide for minimum standards for certain types of fruits and
(and as is the case for all FDA guidance documents), will be
prevention standards that are in S. 510.
vegetables, as needed to minimize the risk of serious adverse
nonbinding and will represent FDA’s current thinking on
health consequences. Among other requirements, the final
these topics.
Requires the Secretary to update the 1998 guidance for
rule shall provide for coordination of education and
minimizing hazards in fresh fruits and vegetables.
enforcement activities with state and local officials, minimize
Also, the Hamburg and Taylor testimonies express support
recordkeeping burdens, and describe the variance process
for § 104 of the House bill.
and the types of permissible variances that the Secretary may
grant to states and foreign countries to address local growing
conditions. Effective dates for compliance are phased in for
small and very small business (see below). The Secretary may
coordinate with USDA and 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).
CRS-58

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 (Amendment)
This section shall not apply to facilities subject to FFDCA §
418 (Hazard Analysis and Risk-based Preventive Controls), as
established by this act.
Failure to comply with requirements under this section is
prohibited. Amendments made by this section do not limit
the authority of the Secretary under the FFDCA or the
Public Health Service (PHS) Act [42 U.S.C. § 201 et seq.] to
revise, issue, or enforce product and category-specific
regulations, such as those for 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 smal and very smal businesses
apply: smal businesses (as defined by the Secretary) are to
have 1 year after final regulation are promulgated, and very
smal businesses (as defined by the Secretary) 2 years after
final regulations. Requires the Secretary to issue a ”small
entity compliance policy guide” setting forth the
requirements of such regulations to assist 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.
INSPECTION OF FACILITIES (See also “Targeting of Inspections”, “Mandatory Recall Authority”, and “Mitigating Effects on Small Business and Farming Operations” sections of this
report, and 81 row of this table.)
Reform advocates argue that many of the recent problems
Risk-Based Inspection Schedule (§ 105)
Targeting of Inspection Resources for Domestic
that have led to illness outbreaks and recalls might have been
Facilities, Foreign Facilities, and Ports of Entry;
avoided if inspectors were more frequently present in plants
Amends § 704 (Inspection, in the General Authority chapter
Annual Report (§ 201)
to monitor sanitary conditions and processes. Due to the
of the FFDCA) to require each § 415-registered facility to be
differing laws and circumstances that apply to FSIS, for
inspected randomly by officers duly designated by the
Subsection (a) of this section establishes a new FFDCA § 421
example, that agency’s inspectors are in meat and poultry
Secretary at a frequency based on the risk of the facility. The
(in the food chapter of the FFDCA), requiring the Secretary,
CRS-59

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 (Amendment)
slaughter and processing plants every day, where they must
Secretary may use federal, state, or local officials for
with respect to facilities that must register under FFDCA §
organoleptically (by the senses) examine every live animal and domestic inspections and foreign country representatives for
415, to al ocate inspection resources according to the
every carcass for defects, and must pass every item before it
foreign ones. The inspection schedule must be implemented
“known safety risks” of the food and countries involved, as
can enter commerce.
within 18 months of enactment and fol ow these prescribed
well as the facility’s compliance history, the rigor of its hazard
categories and frequencies:
analysis and risk-based preventive controls, among other
Current law, which derives from FFDCA § 704 (in the
stated criteria. Establishes separate inspection frequencies
General Authority chapter of the FFDCA), authorizes but
• Category 1, a high-risk food facility that manufactures or
and increasing frequency rates for domestic and foreign
does not require FDA to inspect food facilities. Therefore, no processes food, must be inspected at least every 6-12
facilities for both high-risk and non-high-risk entities.
periodic inspection frequency is currently required.
months;
Establishes requirements for identification and inspection at
Obama Administration: The FSWG stated that the
• Category 2, a low-risk facility that manufactures or
ports for imported foods, including consideration of whether
Administration would work with Congress on “critical
processes food or a facility that packs or labels food, must be
the shipment has been certified under a voluntary qualified
legislation that will provide key tools .... to keep food safe.”
inspected at least every 18 months to 3 years;
importer program or other criteria.
One tool it cited was “the ability to use resources flexibly to
The Secretary shall improve coordination and cooperation
target food at the highest risk and achieve the maximum gain
• Category 3, a food facility that holds food, must be
with the Secretaries of Agriculture and Homeland Security to
for public health.” However, Dr. Hamburg’s testimony noted
inspected at least every 5 years.
target food inspection resources. It also authorizes
several issues regarding § 105 of the House bill (as
Authorizes the Secretary to modify the types of food facilities interagency agreements regarding seafood (involving HHS,
introduced prior to subcommittee markup), including both
within each category, to alter inspection frequencies if
DHS, Commerce Department, and the Federal Trade
the large amount of resources needed to meet the inspection needed to respond to illness outbreaks and recalls, and to
Commission, among other agencies); such agreements may
goals in the bill and the difficulty of hiring and training the
inspect a facility more frequently than specified. In doing so,
include examining and testing seafood imports, coordinating
additional staff that would be needed. She recommended
the Secretary is to consider the type of food at the facility, its inspections of foreign facilities, standardizing data, among
modification “to take into account the operational challenges
compliance history, whether an importing facility is certified
others. Provides for advisory committee consultation within
involved, such as by changing these inspection frequencies ....
(under the new certification requirements the bill would set;
HHS with respect to allocating inspection resources.
flexibility to modify the inspection requirements based on the see below), and other factors determined relevant by the
best available data on risk,” among other things. In his
Secretary. The Secretary is authorized to publish in the
Subsection (b) of this section requires the Secretary to
subsequent testimony on the House committee-approved
Federal Register adjustments to inspection frequencies in
report to Congress, by February 1 of each year, providing
bill, Mr. Taylor expressed support for its flexibility to adjust
category 2 and 3 facilities, and is required to publish in the
specified information regarding: domestic and foreign food
inspection frequencies.
Federal Register any proposed modifications of the
facility inspections (including those scheduled but not
completed); food imports; and FDA foreign offices. Such

categorization of any facility or facility type. The Secretary
must submit an annual report on the inspections to
reports shal be made publicly available.
Congress, which is to include numbers inspected and cost
estimates, and also to submit a 3-year report on any needed
adjustments to the risk-based inspection schedule. These
recommendations must consider a number of factors listed in
this section such as the nature of the food product and how
it is handled; its association with food-borne illnesses, and
others.
CRS-60

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 (Amendment)
RECORDKEEPING REQUIREMENTS AND FDA ACCESS TO RECORDS (See also “Recordkeeping” and “Mitigating Effects on Small Business and Farming Operations” sections of
this report.)
Many advocates of reform argue that recordkeeping
Access to Records (§ 106)
Inspections of Records (§ 101)
requirements must be strengthened to improve the ability of
regulators to determine whether firms are complying with
Broader than S. 510; amends FFDCA § 414(a) regarding
Amends FFDCA § 414, which contains one standard (trigger)
the law and to facilitate efforts to find the source of problems Records Inspection. Although much of the amended language
for records access, by creating two such standards. The first
(including during product recal s) when they do occur. One
appears similar to existing language, several qualifying phrases
is somewhat similar to current law by authorizing access “If
of their concerns has been that records are not required to
are now absent. For example, the bill broadens the ability to
the Secretary has a reasonable belief that an article of food
be maintained in electronic format, which if required, these
access records by deleting the following conditional phrase in
and any other article of food that the Secretary reasonably
advocates assert, would greatly speed outbreak response.
the current law: “If the Secretary has a reasonable belief that
believes is likely to be affected in a similar manner is
Related issues include the types of records to be kept, how
an article of food is adulterated and presents a threat of
adulterated and presents a threat of serious adverse health
detailed they should be, how long they should be kept, and
serious adverse health consequences or death to humans or
consequences or death to humans or animals...” The second
access and use of these records by authorities. For example,
animals...” (Drafters of the bill view this as new authority to
standard authorizes access “If the Secretary believes that
are the current legal premises for accessing records (see
access records during routine inspections.) The bill also no
there is a reasonable probability that the use of or exposure
below), adequate? Proposals for increased recordkeeping
longer requires that “written notice” be provided in advance
to an article of food, and any other article of food that the
requirements often raise questions about the intrusiveness of
of accessing records. However, records not required to be
Secretary reasonably believes is likely to be affected in a
government, privacy concerns, and the protection of sensitive immediately available at the start of a records inspection
similar manner, will cause serious adverse health
commercial information (trade secrets), for example.
must be immediately available if requested in advance by
consequences or death to humans or animals...” It appears
letter. Also, relevant records (i.e., for access and copying) are that by invoking the second standard, the Secretary would no
FFDCA § 414 currently authorizes the Secretary, by
to be all those “relating to such article bearing on whether
longer be required to have a reasonable belief that a food is
regulation, to require that food establishments (except farms
the food is adulterated, misbranded, or otherwise in violation adulterated in order to have access to records.
and restaurants) maintain certain records regarding foods,
of this Act...” rather than the higher current threshold—
including immediate previous sources, and immediate
which is those records “needed to assist the Secretary in
Also apparently new under both standards would be the
subsequent recipients. “If the Secretary has a reasonable
determining whether a food is adulterated and presents a
ability to access records if “any other article of food” could
belief that an article of food is adulterated and presents a
threat of serious adverse health consequences.”
be similarly affected, such as food produced on the same
threat of serious adverse health consequences or death to
manufacturing line as an implicated food, or food produced
humans or animals,” such records must be made available for
New provisions spell out the conditions under which the
using implicated ingredients. Under either trigger, a designee
inspection and copying upon written notice. (Emphasis
Secretary could require remote access to records (i.e., not
of the Secretary is to be granted access to records upon
added.) The Secretary is required to take appropriate
appear at a facility to review them), notably where “...the
presentation of appropriate credentials and a written notice
measures to ensure that unauthorized disclosure of any trade Secretary has reasonable belief that an article of food
to such person, at reasonable times and within reasonable
secret or confidential information is prevented.
presents a threat of serious adverse health consequences or
limits and in a reasonable manner. Requirements apply to all
death to humans or animals.”
records relating to the manufacture, processing, packing,
Obama Administration: The FSWG stated that the
distribution, receipt, holding, or importation of a food, in any
Administration would work with Congress on “critical
Restaurants would be subject to some records access
format (including paper and electronic formats), and at any
legislation that will provide key tools .... to keep food safe.”
requirements. However, the only distribution of records
location. No specific format is required. Farms and
One tool it cited was “the ability to access basic food safety
which may be required of restaurants under this subjection
restaurants would continue to be excluded under FFDCA §
records at facilities.” The Hamburg and Taylor testimonies
are those showing the restaurant’s suppliers and subsequent
414.
express support for § 106 of the House bill.
distribution other than to consumers.
See also “Enhancing Tracking and Tracing of Food and
Also, states that access to records provisions do not apply to Recordkeeping” (§ 204)
farms—except that a farm owner, operator, or agent must
permit an officer or employee of the Secretary to have access
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Administration Statements
H.R. 2749 (House-passed)
S. 510 (Amendment)
to and copy al records relating to an article of food that is
produced, manufactured, processed, packed, or held on the
farm. This exception applies only if the article of food either:
is a fruit, vegetable, nut or fungus that is subject to a standard
under new § 419A (see Safety Standards for Produce and
Certain Other Raw Agricultural Commodities, §104); or is
the subject of an active investigation by the Secretary of a
foodborne illness outbreak and is further not a grain or
similarly handled commodity (generally, the list in the bill
encompasses the row crops covered by USDA price
supports).
Additional y for farms, that Secretary must as soon as
practicable (in coordination with the Secretary of
Agriculture) identify and issue guidance on one or more
fruits, vegetables, nuts, or fungi where access to records will
be used. This section also requires such identification to be
based on illness outbreaks, requires its expiration when the
new § 419A rules take effect, and requires the Secretary to
consult with the Secretary of Agriculture in issuing
regulations “with respect to farms under this subsection and
shal take into account the nature of and impact on farms,”
among other things.
(See also the records provisions in “Traceability of Food,” §
107, and “Registration for Customs Brokers,” § 205.)
TRACEABILITY OF FOOD (See also “Mitigating Effects on Small Business and Farming Operations” and “Notification of Contaminated Products and Product Tracing” sections of this
report.)
Traceability means the ability to follow the movement of a
Traceability of Food (§ 107); Unique identification
Enhancing Tracking and Tracing of Food and
product through its stages of production and distribution. As
number for food facilities, importers, and custom
Recordkeeping (§ 204)
a food safety tool, traceability helps government authorities
brokers (§ 206)
and industry officials to locate the source of contamination
The Secretary, in coordination with USDA and state officials,
(traceback) and to locate those who may have received the
Amends FFDCA § 414 to require the Secretary to establish by
shal improve the capacity of FDA to effectively and rapidly
contaminated food (trace forward). Records sufficient to
regulation a tracing system for food in, or to be imported into,
track and trace foods in the event of an outbreak. Within 270
identify products and to trace them quickly are considered to the United States. These regulations are to enable the
days of enactment, the Secretary is required to establish pilot
be important prerequisites for a successful recall. (see
Secretary “to identify each person who grows, produces,
projects in coordination with the food industry to explore
below.) Among other issues are the potential administrative
manufactures, processes, packs, transports, holds, or sel s such
and evaluate methods to rapidly and effectively identify
and cost burdens that a more extensive regulatory program
food in as short a timeframe as practicable but no longer than
recipients of food to prevent or mitigate a foodborne illness
might impose on those in the food system, as well as privacy
2 business days.” The Secretary is authorized to include in such outbreak and to address credible threats of serious adverse
concerns about records.
regulations the use of lot numbers, a standardized format for
health consequences or death to humans or animals as a
pedigree information, and the use of a common food
result of such food being adulterated or misbranded.
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Background, Applicable Current Law, and
Administration Statements
H.R. 2749 (House-passed)
S. 510 (Amendment)
§ 306 of the Public Health Security and Bioterrorism
nomenclature.
Participants are to include one or more projects with the
Response Act of 2002 amended the FFDCA to require any
However, before promulgating regulations the Secretary is
processed food sector and one or more projects
person who manufactures, processes, packs, transports,
required to first identify tracing technologies and
coordinating processors or distributors of fruits and
receives, holds or imports foods into the United States to
methodologies that can enable each of the food industry
vegetables that are “raw agricultural commodities,” reflecting
keep records that enable the identification of the immediate
sectors to: maintain the full pedigree of the food from source
the diversity of the food supply and include at least three
previous supplier and the immediate subsequent recipient of
through subsequent distribution; make traceback interoperable different types of foods that have been the subject of
the food (FFDCA § 414; see also “Records Access and
with other systems; and use a unique identifier for each facility. significant outbreaks during the 5-year period preceding
Records Inspection,” above).
Prior to proposing regulations, the Secretary also first must, to
enactment, among other criteria for project selection
intended to inform future rule promulgation. The Secretary
Obama Administration: In July 2009, the FSWG
the extent practicable, assess costs, benefits and feasibility of
shall report to Congress its findings for improving the
announced a number of steps the Obama Administration was
adopting such technologies; conduct at least two public
tracking and tracing of food within 18 months of enactment.
taking, under existing authorities, to improve traceability,
meetings; and conduct one or more pilots.
including:
The traceback regulations wil apply to agricultural producers
The Secretary, in coordination with USDA and state
departments of health and agriculture, shall collect additional
• issue draft guidance on what industry could do to establish (and retailers), but the provision specifically exempts food that
data to assess product tracing technologies, among other
product tracing systems;
is produced on a farm or fishery (wild or farmed) and sold by
that farm or fishery directly to a consumer, restaurant, or
information. The Secretary, in consultation with USDA, shall
• require federal agencies are to implement a new “incident
grocery store. However, such farms and fisheries must keep
also establish within FDA a product tracing system to receive
command system to address outbreaks of foodborne illness;
records for at least 6 months documenting the restaurants or
information needed to track and trace food.
• increase FSIS capacity of its public health epidemiology
grocery stores to which it sold; and the restaurants and
The Secretary shal publish a notice of proposed rulemaking
liaison program to State public health departments through
grocery stores are required to keep records documenting the
to establish additional recordkeeping requirements for high-
new hires and expanded outreach;
farm source. The Secretary may also exempt a food or a type
risk foods, subject to certain specified conditions (no later
of facility, farm, or restaurant from the regulations, or modify
than two years after enactment). The Secretary shal
• ask State and local agencies to update their emergency
the requirements for these entities, if the Secretary
designate such high-risk foods within one year after
operations procedures to be consistent with new food
“determines that a tracing system for such food . . is not
enactment based on criteria specified in the provision, and
disease outbreak guidelines being issued by the Council to
necessary to protect the public health.” For this latter category shall publish the list of foods designated as high-risk, which
Improve Foodborne Outbreak Response;
of exemptions, each person who produces, manufactures,
may be subject to updates and revision. The provision
processes, packs, transports, or holds such food stil must
• improve col aboration between the CDC and the States
addresses information protection; requirements for public
maintain records that identify the immediate previous sources
to evaluate and optimize best practices for more effective
input; rules on retention of records; and less restrictive
of the food and its ingredients and the immediate subsequent
outbreak investigations, and launch a new system to facilitate
requirements (as specified) for: farm-to-school or farm-to-
recipients.
information-sharing and adoption of best practices.
institution programs of USDA and other related programs;
Contains language limiting applicability to farms, including
“identity-preserved labels” with respect to farm sales of food
In its July 2010 progress report, the Administration
requirements that the Secretary coordinate with the Secretary
that is produced and packaged on a farm; food that is
announced that “FDA has conducted a pilot study on a
of Agriculture when conducting pilot projects with respect to
produced through the use of a fishing vessel; producers of
tracing system, and HHS, in collaboration with USDA, has
farms and when issuing regulations that will impact farms.
commingled raw agricultural commodities; grocery stores;
rolled out an enhanced and updated www.foodsafety.gov site
Furthermore, any new tracing system with respect to grain or
direct farm sales to consumers or grocery store; and others.
to provide consumers rapid access to information on food
any “similarly handled commodities” (generally, those row
The Secretary may modify requirements, or exempt a food
recal s,” among other actions.
crops that have been covered by USDA price supports) must
or facility from them, if product tracing requirements are not
Also, the Hamburg and Taylor testimonies express support
be “limited to enabling the Secretary to identify those who
needed to protect public health.
for § 107 of the House bill.
received, processed, packed, transported, distributed, held, or
The Secretary shall submit a report to Congress “taking into
sold” such a commodity “from the initial warehouse operator
consideration the costs of compliance and other regulatory
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Administration Statements
H.R. 2749 (House-passed)
S. 510 (Amendment)
that held” it “for any period of time to the ultimate consumer.” 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 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 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.
FUNDING AND FEES (See also “Paying for Food Safety with User Fees” and “Mandatory Recall Authority” sections of this report.)
Many critics argue that—irrespective of the need, if any, to
Various Sections (§ 101, § 108, § 203, § 204)
Authority to Collect Fees (§ 107)
reform food safety statutes and organization—a fundamental
problem has been the lack of sufficient funding and staff to
Authority to assess new types of food-related fees appear in
Authorizes FDA to col ect two types of fees related to food:
carry out congressional y mandated (and existing)
four sections of the House bill.
export certification fees and user fees. The export
responsibilities to ensure a safe food supply.
certification provisions in current law are amended to allow
Under § 101, Changes in Registration of Food
food exporters to request that the Secretary certify that
Proposed increases in program spending raise a variety of
Facilities, the Secretary is required to assess and collect a
exported foods comply with provisions in the FFDCA, and
policy issues. Requests for higher appropriations always
facility registration fee each year from facilities required to
would thus enable the associated fee to be charged to the
compete with other priorities throughout the federal
register under FFDCA § 415. This fee is to be set at $500 per exporter. The food user fees are established by inserting a
discretionary budget (the programs do not operate, like farm
facility in FY2010; for FY2011 and each subsequent fiscal year, new FFDCA § 743 : “Part 6–Fees Related to Food.” The new
support programs, for example, as mandatory
the fee is to be adjusted to reflect the cost of inflation, under
part authorizes, indefinitely, the assessment and collection of
authorizations). Such requests currently are being made
a specified formula. § 101 also sets a maximum annual fee
four user fees:
during a period of huge budget deficits. Efforts to fill
payment of $175,000 for those who have multiple facilities.
perceived shortfal s through new fees on the food industry
Other provisions in this section: require the Secretary to
• fees paid by domestic facilities subject to a reinspection
always meet with resistance, both from the companies that
hold a public meeting each fiscal year to explain the fees’ use
(to cover reinspection-related costs);
and to solicit stakeholder views; are intended to ensure that
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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 (Amendment)
would have to absorb such costs, and from consumer
these fees do not supplant FDA appropriations or reduce
• fees paid by domestic facilities and importers subject to
advocates, who have long argued that industry funds might
HHS Department staffing; address their collection, crediting
food recal s (to cover food recal activities performed by the
compromise public health programs.
and availability vis a vis appropriations; sunset the fees after
Secretary);
FY2014; and require annual reports to Congress. “Food
Congressional appropriators have steadily increased funding
safety activities” and “costs of food safety activities” are
• fees paid by importers participating in the voluntary
for FDA food activities in recent years: from about $440
extensively defined in this section. The provisions in this
qualified importer program (to cover administrative costs of
million FY2005 and FY2006; $510 million in FY2008; $710
section are modeled in part on existing user fee authorities
the program); and
million in FY2009; and $780 million in FY2010. $1.04 billion
for drugs and devices.
was requested for FY2011.
• fees paid by importers subject to reinspection (to cover
Under § 108, Reinspection and Food Recall Fees
reinspection-related costs).
In general, FDA’s fee-funded programs for drugs and devices
Applicable to Facilities, the Secretary is required to assess
have finite appropriations authorities that sunset, prohibiting
Overdue fees are treated as claims of the United States
and collect a fee from each facility that either: violates any
the agency from collecting fees beyond the authorized time
Government under 21 U.S.C. § 37. The Secretary is required
food-related requirement of the FFDCA and therefore must
frame. These authorities do not apply to food safety
to report annual y to Congress describing the entities paying
undergo additional FDA inspection; or is subject to a food
programs at this time. In addition, some discretionary-funded
fees, and the fees assessed and collected for each year.
recall. The Secretary must set the fee amount at a level to
grant programs have finite appropriations authorities, and
fully cover the reinspection and/or recall costs and use the
The Secretary is required to establish and publish the fee
may or may not continue to be funded if authority expires.
collection solely for that purpose. If the Secretary determines amounts annual y, setting fees so that each one covers 100%
But, in general, FDA’s enforcement activities, such as those
that a recall “was inappropriately required,” the fee must be
of the cost of the associated activity, with certain caveats. For
for food safety, are based in broad, permanent authorities in
waived or refunded. Other language here addresses their
the first five years that user fees are assessed, the Secretary
the FFDCA. These authorities do not expire, and they are
collection, crediting and availability vis a vis appropriations,
is to include a surcharge in order to recoup the costs
not accompanied by authorized levels of appropriations.
with a sunset for the fees after FY2014.
associated with establishing the user fee programs. Fees
Decisions to apportion annual appropriations among FDA’s
col ected for a given fiscal year for food recal activities may
various programs and activities are made through the annual
Under § 203, Exportation Certificate Program, the
not exceed $20 million. Fees collected for a given fiscal year
appropriations process without explicit directives in
Secretary is authorized to impose a fee for food export
for reinspection of both domestic facilities and importers
authorizing legislation.
certifications that meet the specifications of a foreign
may not exceed $25 million combined. Despite these
purchaser and that do not conflict with the destination
FDA is currently authorized to collect several types of fees.
limitations, the Secretary may collect fees from facilities or
country’s laws. (Such fees already may be charged for
Among them are user fees and export certification fees,
importers who become subject to the fees after the
certifications of some other FDA-regulated products.) The
neither of which may currently be collected for food-related
limitations are reached. The Secretary must credit to the
fee shall be “reasonably related” to the cost of issuing such
activities. FDA’s authority to collect user fees extends to
following year any fees collected in excess of actual costs,
certificates; this fee authority is permanent.
human prescription drugs, medical devices, and animal drugs,
and adjust fee amounts for that following year to account for
under FFDCA Chapter VII, Subchapter C, §§ 735-740.
Section 204 establishes a new FFDCA § 744, requiring the
the excess fees and other factors the Secretary determines
General y, these fees can only be used to fund the “process
Secretary to assess and col ect a $500 annual fee for the
are appropriate.
for the review of applications.” (FDA reviews applications to
registration of an importer of food, with administrative
The Secretary is authorized to collect fees only to the extent
determine whether to permit drugs, medical devices, and
provisions somewhat comparable to those set under § 101
that amounts have been specified in advance in
animal drugs to be legally marketed. Prior approval is not
(above). (This fee is to be tied to the new requirement that
appropriations acts. Additional “triggers” apply. Fees
required for most foods, which can be legal y marketed
such importers begin to register with FDA within one year of col ected in a given year must be refunded unless
without the agency’s prior permission.) The user fee
enactment.) Importers that already must pay the facility fee
appropriations to FDA for food safety activities are
programs have been authorized in five-year increments. Each
under § 101 are exempt from this importer registration fee.
maintained at the FY2009 level, with specified adjustments.
authorization specifies the fee amounts FDA may collect
This fee authority sunsets after FY2014.
Fees can be used solely to fund the specified food safety
annual y, and makes the authority to col ect these fees
activity.
contingent upon “triggers,” which require that appropriated
and internally allocated funding amounts for certain activities
Note: The proposed food user fee is different from existing
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Administration Statements
H.R. 2749 (House-passed)
S. 510 (Amendment)
meet specified threshold levels.
user fees in several ways. First, the proposed fee would be
authorized indefinitely, while each of the existing user fees
FDA’s authority to collect export certification fees extends
have been authorized in five-year increments. Second, the
to drugs, medical devices and biological products, according
fees would be used to fund inspection and enforcement
to FFDCA § 801(e)(4). A person who exports a human drug,
activities for foods on the market. For other products, the
animal drug, or device may request that the Secretary certify
existing user fees only fund application-review related
in writing that the product meets FFDCA requirements. If
activities, as defined in the law—though, as noted above,
the Secretary issues a written export certification, a fee may
FDA does not inspect foods before they can be marketed as
be charged.
it does some of the other products that it regulates. Third,
Obama Administration: In addition to requesting
the act does not authorize specific fee levels in advance, but
increased funds for FY2010 (see above), the Administration
rather allows the Secretary to set fee levels based upon
has endorsed the registration, reinspection, and export
estimated costs. For currently authorized fees, the amounts
certification fees in §§ 101, 108, and 203 of the House bill.
are articulated in law, either individually, or in aggregate, for a
given type of fee.
Funding for Food Safety (§ 401)
This section authorizes, for activities of FDA’s Center for
Food Safety and Applied Nutrition, Center for Veterinary
Medicine, and related field activities in the Office of
Regulatory Affairs, such sums as may be necessary for
FY2011-FY2014. In addition, the Secretary is required to
increase the field staff of these three entities with a goal of
not fewer than: (1) 4,000 staff members in FY2011; (2) 4,200
staff members in FY2012; (3) 4,600 staff members in FY2013;
and (4) 5,000 staff members in FY2014. Within the total, field
staff for food defense activities and for smuggled food
detection and removal shal be increased by 150 employees
by FY2011.
THIRD PARTY ACCREDITATION (See also “Food Imports” section of this report, and 69 and 81 rows of this table.)
The use of so-called third parties is increasingly being
Certification and Accreditation (§ 109, part)
Accreditation of Third-Party Auditors (§ 307)
promoted as a method for helping regulators such as the
FDA to carry out their oversight responsibilities, particularly
Appears to be less detailed with regard to how the Secretary
Amends FFDCA Chapter VIII (regarding imports and exports),
when they are being asked to stretch and carefully target
is to establish a third-party certification program. As noted,
adding a new § 808, for a system of third-party auditors and audit
finite inspection dollars and personnel. However, the idea is
qualified certifying entities are to be accredited and given the
agents that are accredited to certify that entities involved with
controversial, particularly among food safety advocates, who
responsibility to provide such certifications when the
imports are meeting applicable FDA requirements. Generally,
have expressed concern about potential conflicts of interest
Secretary determines such certifications are needed, and the
the Secretary would first recognize accreditation bodies. Such
between auditors and the companies they audit and about
specifics of that certification, including its format, would be
bodies in turn could accredit the third-party auditors or audit
potential y less rigorous oversight. They cite a number of
left to the Secretary’s regulatory discretion. § 109 defines
agents, who in turn could be tasked to certify eligible entities.
recent food safety crises including the Salmonella
“qualified certifying entity” as “an agency or a representative
Defines the following terms: audit agent, accreditation body,
contamination of peanut products in late 2008 and early
of the government from which the article originated, as
third-party auditor, accredited third-party auditor, consultative
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H.R. 2749 (House-passed)
S. 510 (Amendment)
2009, even though the peanut product supplier had passed
designated by such government or the Secretary; or an
audit, eligible entity, and regulatory audit.
several private third-party and state inspections.
individual or entity determined by the Secretary or an
accredited body recognized by the Secretary to be qualified
The Secretary must establish the new system within two years of
Among many questions is the definition of a “third party.”
to provide a certification...”
enactment and is required to: promptly revoke recognition of
Broadly, it may be any entity or person that is formal y
accreditation bodies found not in compliance with this section’s
assigned one or more responsibilities that otherwise would
Requires the Secretary to issue regulations to ensure that
requirements and develop model accreditation standards (within
be performed by another entity. In practice and in proposed
certifying entities and their auditors are free from conflicts of
18 months after enactment), taking into account existing
legislation, third parties might variously and specifically be
interest (in doing so, the Secretary may rely on or
standards so as to avoid duplication of efforts and costs.
defined as a state or local agency, another federal agency, a
incorporate international certification standards), Contains
Accreditation bodies must submit to the Secretary a list of all
foreign government, a professional or scientific body, or even extensive language on what these regulations are to stipulate,
accredited third-party auditors and audit agents they have
a private company, often one that specializes in the task to be such as that entities have written policies; that they obtain
accredited.
performed. Private companies frequently rely on third party
and maintain annual declarations of all personnel involved in
auditors, certifying agents and the like, often including
audits regarding their financial interests in any producer,
Accreditation bodies must, prior to accrediting a foreign
provisions in their contracts with suppliers, for example, that
manufacturer, and other specified types of food companies;
government or foreign government agency, perform reviews and
a third party verify that certain specifications—whether
that they not be owned, operated, controlled, or have any
audits of that government or agency’s food safety programs,
safety, quality, quantity, or other desired attributes—are
other financial ties to those or the products they are
systems, and standards, as the Secretary deems necessary, to
being achieved. Within the federal government, examples
certifying. (However, the certifying entity could provide
determine that the foreign government is capable of ensuring
include a variety of voluntary third-party auditing programs.
consultative services to a facility it is certifying so long as the
that entities or foods it certifies will meet the requirements of
For example, “Process Verification and Audit Based
Secretary has approved its procedures ensuring the
the FFDCA. Prior to accrediting foreign cooperatives and other
Programs,” operated by USDA’s Agricultural Marketing
separation of these two functions.)
third parties, accreditation bodies must perform reviews and
Service (AMS) and are funded through user fees. These
audits as the Secretary deems necessary to determine that the
programs are intended primarily to certify food quality and
The Secretary must require that, to the extent applicable, any entities to be certified have systems in place to ensure the
marketing attributes, as opposed to safety requirements per
certification provided by a certifying entity be renewed
entities or foods will meet the requirements of the FFDCA.
se.
whenever the Secretary deems it appropriate; and he/she
must refuse to accept any certification determined to be no
Accreditation bodies may not accredit a third party auditor
FDA appears to have argued in the past that its authority is
longer valid or reliable. The Secretary must provide for the
unless it agrees to issue a written food or facility certification to
broad enough, under the FFDCA and the PHS Act, at least to electronic submission of certifications, in coordination with
accompany each food shipment into the United States from an
propose regulations on how independent sampling services
Customs and Border Protection.
eligible entity. The Secretary must consider certifications of
and private laboratories can be used to satisfy food import
foods offered for import and participation in the voluntary
requirements. However, FDA does not currently regulate
Authorizes the Secretary, in evaluating an accreditation body,
qualified importer program when targeting inspection resources
private laboratories that analyze imported, FDA regulated
to observe that body’s on-site audits of qualified certifying
and must use certification to determine whether food meets the
goods. (Under FFDCA § 704, FDA has been required to have
entities, and to conduct on-site audits of certified facilities
requirements for import and to determine whether facilities are
published criteria for accrediting independent persons to
“upon request. .... and upon presentation of appropriate
eligible for the voluntary qualified importer program established
conduct inspections related to Class II and III devices.)
credentials, at reasonable times and within reasonable limits
in § 302 of this act. Accredited third-party auditors can only issue
and in a reasonable manner ....” to include access to records.
food and facility certifications after conducting certain audits and
In January 2009, following a request for information and
activities. Only the Secretary and accredited third-party auditors
publication of a draft document, FDA issued guidance setting
can provide facility certifications. Only the Secretary, a
criteria for others’ use of voluntary third-party certification
Secretary-designated agency or representative of the country
programs for foods and animal feeds, noting that the federal
from which the food for import originated, or accredited third-
government “supports voluntary certification programs as
party auditors can provide food certifications.
one way to help ensure products meet U.S. safety and
security standards and to allow federal agencies to target
Accredited third-party auditors or audit agents must prepare
their resources more effectively.” FDA has also published a
audit reports, which are to include a number of specified
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S. 510 (Amendment)
notice of a pilot program of voluntary third-party certification
elements; provide, at the Secretary’s request, an onsite audit
for imported shrimp.
report or other reports or documents required for the audit
process for any eligible entity it has certified (with certain
Obama Administration: Dr. Hamburg’s testimony
exceptions); and immediately notify the Secretary of the
expresses support for relying not only on foreign
discovery during an audit of “a condition that could cause or
governments for international inspections but also having the
contribute to a serious risk to the public health” and the
flexibility to explore use of an accreditation system and audit
identification of the eligible entity subject to the audit. Third-
the performance of accredited third parties.
party auditors and audit agents must adhere to a series of

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 of ered 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.
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S. 510 (Amendment)
LABORATORY ACCREDITATION (See also 66, 81 and 94 rows of this table.)
Neither the FFDCA nor applicable regulations address the
Testing by Accredited Laboratories (§ 110)
Recognition of Laboratory Accreditation for Analyses
accreditation of food laboratories or the establishment of
of Foods (§ 202)
laboratory networks.
Establishes a new FFDCA § 714, which requires the Secretary
to establish a standards-based program for the recognition of
Subsection (a) establishes a new FFDCA § 422, requiring the
FDA continues to support an existing Food Emergency
laboratory accreditation bodies that accredit laboratories to
Secretary, within two years of enactment, to establish a program
Response Network (FERN), a nationwide network made up
perform analytical testing for the purposes of this section. In
for food testing by accredited laboratories that meet certain
of more than 130 federal, state and local public health
evaluating whether such bodies meet the Secretary’s
requirements established by the Secretary; to establish a publicly
laboratories that support emergency response activities
standards, the Secretary is authorized to observe these
available (subject to national security concerns) registry of
related to food defense and food safety. The FDA Office of
bodies’ on-site audits of laboratories, and to conduct an on-
accrediting bodies recognized by the Secretary and accredited
Regulatory Affairs publishes a Laboratory Manual with a
site audits under specified conditions. The Secretary is
laboratories (such accredited entities would be required to
section on “Private Laboratory Guidance.” The Guidance
required to publish on the FDA website a list of accreditation report any changes to the Secretary). Foreign labs would need to
seeks to “establish a uniform, systematic, and effective
bodies.
meet the same accreditation standards as domestic labs. The
approach to ensuring that private labs performing analyses on
Secretary shall develop model accreditation standards that
FDA-regulated imported commodities submit scientifically
Any analytical testing must be done by a laboratory that is
address sampling and analytic procedures, quality controls,
sound data.” The Guidance, although unenforceable,
accredited by an above-accredited body and that samples
personnel training and qualifications, and other matters. The
provides recommendations on sampling techniques,
such articles with adequate controls to ensure the integrity
Secretary shall review accreditation bodies at least once every
requirements of lab analysts, reviewing the analyzed packages, of the samples, except that testing pursuant to FFDCA
five years and promptly revoke recognition for an accrediting
and auditing analyzed samples.
§801(a) (relating to testimony on refused imports) must be
body that is not in compliance with this section. Food testing
by an independent laboratory. This section contains
shal be conducted by accredited labs no later than 30 months
In January 2009, FDA issued guidance regarding voluntary
notification requirements for accreditation bodies and for
after enactment, unless otherwise exempted.
third-party certification programs for foods and feeds. The
others (such as the results of all analyses conducted), among
guidance does not focus on laboratory accreditation, but
other provisions. Any violation of this section’s requirements
Food testing in the following situations shall be conducted by
rather the ways in which third-party certifiers should use
is considered a prohibited act under the FFDCA.
a federal laboratory or a laboratory accredited according to
laboratory results in their assessments. The guidance, which
the requirements of this section whenever such testing is: (1)
also is not enforceable, says that laboratories should conform
by or for an owner or consignee in response to a specific
to existing international standards and guidelines.
testing requirement under the FFDCA or its regulations
when applied to address an identified or suspected food

safety problem and as required by the Secretary as the
Secretary deems appropriate; and (2) on behalf of an owner
or consignee in support of an imported food submission
under Section 801(a) and under an FDA Import Alert that
requires successful consecutive tests.
Any such testing results must be sent directly to the FDA,
unless the Secretary by regulation exempts the submission of
those results upon a determination that the results “do not
contribute to the protection of public health.” Certain
exceptions may apply.
If testing performed by an accredited state or local
government laboratory results in a state recalling a food, the
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S. 510 (Amendment)
Secretary shall review the sampling and testing results for the
purpose of determining the need for a national recall, or
other compliance and enforcement activities. This authority
does not limit the ability of the Secretary to review and act
upon information from food testing, including determining
the sufficiency of such information and testing.
Subsection (b) requires the Secretary, within 180 days of
enactment and biennial y thereafter, and in consultation with
federal agencies and state, local, and tribal governments, to
make a publical y available report to Congress regarding
progress in implementing a national food emergency
response laboratory network. Such a network: (1) provides
ongoing surveillance, rapid detection, and surge capacity for
large-scale food-related emergencies, including intentional
adulteration of the food supply; (2) coordinates the capacities
of state, local, and tribal food laboratories, including data
sharing to develop national situational awareness; (3)
provides accessible, timely, accurate, and consistent food
laboratory services nationwide; (4) develops and implements
a methods repository for use by federal, state, and local
officials; (5) responds to food-related emergencies; and (6) is
integrated with relevant laboratory networks administered by
other federal agencies.
MANDATORY RECALL AUTHORITY (See also “Mandatory Recall Authority” section of this report.)
The Secretary does not have mandatory recal authority for
Notification, Nondistribution, and Recall of
Mandatory Recall Authority (§ 206)
foods, except for infant formula under FFDCA § 412(f). A
Adulterated or Misbranded Food (§ 111)
voluntary recal by a manufacturer or distributor may be
Subsection (a) of this section establishes a new FFDCA § 423
undertaken at any time for other foods and al other FDA-
This section establishes a new FFDCA § 420, effective not
regarding recal of food. If the Secretary determines, based on
regulated products. In urgent situations, FDA may request a
later than one year after enactment, which requires certain
information gathered through the reportable food registry
voluntary recall of an FDA-regulated product [21 CFR
persons who place food in commerce to notify the Secretary
under FFDCA § 417 or through any other means, that there is
7.40(b)]. The Secretary has authority under FFDCA § 304 to
of potential food safety problems; provides the Secretary
a reasonable probability that an article of food (other than
seize foods, drugs, and cosmetics that are adulterated or
with authority to request a voluntary recall of food and to
infant formula) is adulterated under FFDCA § 402, or
misbranded when introduced into or while in interstate
order that distribution of a food be ceased; and establishes
misbranded under FFDCA § 403(w) (specifical y regarding
commerce, or while held for sale after shipment in interstate
authority of the Secretary to mandate a recall, with
al ergen labeling), and the use of or exposure to such article
commerce.
procedures reflecting two different levels of threat that may
will cause serious adverse health consequences or death to
be posed by an affected food.
humans or animals, the Secretary shall provide the responsible
Obama Administration: One of the actions announced by
party (as defined in FFDCA § 417) with an opportunity to
the FSWG was to begin enhancing communication to the
FFDCA § 420, subsection (a), requires a responsible party [as
cease distribution and recal such article.
public, including through an improved individual alert system
defined in FFDCA § 417(a)(1)] or a person required to
allowing consumers to receive food safety information such
register to import food under § 801(r) (as established by this
If a person fails to comply voluntarily with a request by the
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as notification of recalls. The FSWG, and the Statement of
act), to notify the Secretary if there is reason to believe that
Secretary to cease distribution or sale of, or to recal , an article
Administration Policy on H.R. 2749, noted support for
an article of food when introduced into or while in interstate
of food, the Secretary may order the person to cease
mandatory recal authority. The Hamburg and Taylor
commerce, or while held for sale (regardless of whether the
distribution and sale, and to immediately notify all persons
testimonies express support for the House bill provision.
first sale) after shipment in interstate commerce, is
“manufacturing, processing, packing, transporting, distributing,
adulterated or misbranded in a manner that presents a
receiving, holding, or importing and selling such article;...and to
reasonable probability that the use or consumption of, or
which such article has been distributed, transported or sold, to
exposure to, the article (or an ingredient or component used immediately cease distribution of such article,” including
in any such article) will cause a threat of serious adverse
products distributed to a warehouse-based third party logistics
health consequences or death to humans or animals. (This
providers. The Secretary shall offer the responsible party an
language is similar to the reporting threshold currently
opportunity for an informal hearing within two days of issuance
established under FFDCA § 417.) Failure to notify the
of such an order. If the Secretary subsequently determines that
Secretary when required is prohibited under FFDCA § 301.
the affected foods should not remain in commerce, the
Secretary shal : amend the order to require a recal ; specify a
FFDCA § 420, subsection (b), authorizes the Secretary to
timetable for the recal ; require periodic reports from the
request a voluntary recal by any person who distributes an
responsible party; and provide notice to consumers to whom
article of food that the Secretary has reason to believe is
the food was or may have been distributed. If, after the
adulterated, misbranded, or otherwise in violation of the
informal hearing, the Secretary determines that adequate
FFDCA.
grounds do not exist for the order’s required actions, the
FFDCA § 420, subsections (c) and (d), authorize the
Secretary shal vacate or modify the order.
Secretary to issue an order to cease distribution of any
Alcoholic beverages are exempt from a mandatory recal or
article of food that the Secretary has reason to believe that
any action pending initial action by the Alcohol and Tobacco
the use or consumption of, or exposure to, an article of food Tax and Trade Bureau.
may cause serious adverse health consequences or death to
humans or animals, with an appeal process and other
The Secretary shall work with state and local public health
administrative matters specified (including limits on the
officials in carrying out this section, as appropriate. In
Secretary’s authority to delegate decisions regarding orders).
conducting a recal under this section, the Secretary shall issue
Subsection (e) requires the Secretary to issue a mandatory
a press release, and other notices as appropriate, to provide
recall order if the Secretary determines that problems have
consumers and retailers with information about the affected
not been addressed through procedures under subsections
articles of food and the risks posed; and shall consult USDA
(c) and (d). Certain requirements of such order are
policies regarding providing to the public a list of retail
stipulated.
consignees receiving products involved in a Class I recall, and
consider providing such a list to the public, if appropriate. If
FFDCA § 420, subsection (f), authorizes the Secretary to
available, an image of the recal ed article must be published on
proceed directly to a mandatory recal order if the Secretary
the FDA website. The Secretary’s authority to issue or vacate
has credible evidence or information that an article of food
recal orders shal not be delegated to anyone other than the
subject to an order to cease distribution presents an
FDA Commissioner and this section shal not affect the
imminent threat of serious adverse health consequences or
authority of the Secretary to request or participate in a
death to humans or animals. In such case, the person must
voluntary recal . The Secretary shal establish an “incident
immediately recall the food while stipulated appeal
command operation” within HHS no later than 24 hours after
procedures are carried out. (“Serious," which distinguishes
the initiation of a mandatory recal that wil adhere to
the thresholds for the routine (subsection (e)) and
requirements for coordinated and timely communication. Not
emergency (subsection (f)) mandatory recall authorities, is
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S. 510 (Amendment)
not defined.)
later than 90 days after enactment the Secretary shal include
on the FDA website a consumer-friendly search engine for
The Secretary is required, as the Secretary deems necessary,
locating information about recalled food.
to notify consumers, and state and local health officials, of any
recall order issued under this section. Failure of a person to
Under subsection (c) of this section, pursuant to FFDCA §
comply with any order issued by the Secretary under this
303(f)(2)(A), a person who does not comply with a recal
section is prohibited under FFDCA section 301. Any articles
order under this section shall be subject to civil money
of food intended for import and subject to a cease-
penalties. Under subsection (d) of this section, failure to
distribution or recall order under this section shall be refused comply with such an order is prohibited under FFDCA § 301.
entry, under FFDCA section 801. Nothing in this section shal
limit the Secretary's authority to assure food safety through
Reporting requirements:
any other provisions of the FFDCA, or the Public Health
• Requires GAO to submit a report to Congress (no later
Service Act.
than 90 days after enactment) that identifies and evaluates
federal, state and local agencies with mandatory recall
authority of food, considers models for famer restitution in the
case of erroneous recal s, and recommends how to minimize
economic costs.
• Depending on the findings in GAO’s review, USDA shall
conduct a feasibility study of implementing a farmer
indemnification program to provide restitution to producers
for incurred losses as a result of an erroneous mandatory
recal . This report wil be submitted to the House and Senate
Agriculture Committees.
• The Secretary shall submit an annual report to the Senate
HELP and House Energy and Commerce Committees on the
use of recal authority under § 423. This report shall identify
foods subject to a public health advisory; the number of
responsible parties given an opportunity to cease distribution
of or recal a food; the number of recal orders; and a
description of instances in which there was no testing for
adulteration.
REPORTABLE FOOD REGISTRY (See also “Notification of Contaminated Products and Product Tracing” and “Mitigating Effects on Small Business and Farming Operations” sections of
this report.)
The FDA Amendments Act of 2007 (FDAAA, P.L. 110-85)
Reportable Food Registry: Exchange of Information
Improving the Reportable Food Registry (§ 211)
created FFDCA § 417, which required FDA to establish a
(§ 112)
reportable food registry to facilitate product identification
Amends FFDCA § 417 to require the Secretary to obtain
and tracing. Under FFDCA § 417, a “reportable food” is “an
The food registry reporting requirements apply to facilities
from a responsible party consumer-oriented information
article of food (other than infant formula) for which there is a that are required to register under FFDCA § 415. This
regarding reportable foods (except for fruits and vegetables
reasonable probability that the use of, or exposure to, such
section of the House bill expands coverage to farms where
that are raw agricultural commodities), no later than 18
food is produced for sale or distribution in interstate
months after enactment: description of the food, affected
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H.R. 2749 (House-passed)
S. 510 (Amendment)
article of food will cause serious adverse health
commerce, to restaurants and other retail food
product identification codes, contact information for
consequences or death to humans or animals,” and
establishments, and to those required by this bill to register
responsible parties, and other information deemed relevant
registered food facilities must notify the FDA electronically
as importers. The bill newly requires the reporting also of
by the Secretary. The Secretary shall also prepare a one-page
about such a reportable food. Although FDA did not meet
documented results of any sampling and testing of a
summary of the reportable food, to be available by internet
the deadline to implement the registry within 1 year of
reportable food article and of a component of a food article,
and for grocery stores, as part of its notification process. If a
enactment of FDAAA, the agency published compliance
including: tests conducted pursuant to new § 418 (Hazard
grocery store sold a reportable food subject to posting, the
guidance for industry in September, 2009, and the reporting
Analysis and Risk-Based Preventive Controls), new § 418A
store shal prominently display such summary information for
requirement became effective at that time.
(Food Safety Plan), new § 419 (Performance Standards), or
14 days no later than 24 hours after the one-page notification
new § 714 (Testing by Accredited Laboratories); analytical
is published. Within one year of enactment, the Secretary
results of facility environmental testing; or any other
shall publish a list of “conspicuous locations” for posting such
information deemed relevant by the Secretary.
notifications. Failure to post a required notification is
prohibited.
This section does not amend the definition of “reportable
food,” which establishes the reporting threshold. The
Secretary must offer an alternative to electronic reporting
for farms, restaurants, and retail food establishments. Finally,
§ 112 of the bill contains extensive language on the
conditions under which food registry information may or may
not be shared with or disclosed to others including other
agencies and to the public.
Note: The bill here references 21 CFR 1.227(b)(3) to define a
farm as “... a facility in one general physical location devoted
to the growing and harvesting of crops, the raising of animals
(including seafood), or both. Washing, trimming of outer
leaves of, and cooling produce are considered part of
harvesting. The term ``farm'' includes: (i) Facilities that pack
or hold food, provided that all food used in such activities is
grown, raised, or consumed on that farm or another farm
under the same ownership; and (ii) Facilities that
manufacture/process food, provided that all food used in such
activities is consumed on that farm or another farm under
the same ownership.” The bill here also makes the same
reference to define a retail food establishment.)
EXPEDITING IMPORTS (See also “Food Imports” section of this report.)
The FFDCA does not explicitly provide authority for
Safe and Secure Food Importation Program (§ 113)
Voluntary Qualified Importer Program (§ 302)
expediting imports. Among the questions raised during the
policy debate: Should importers, or those foreign facilities
Amends FFDCA Chapter VIII (regarding imports and
Amends FFDCA Chapter VIII (regarding imports and
which supply them, that have good histories of compliance
exports), adding a new § 805, which appears to leave more
exports), adding a new § 806. It requires the Secretary,
with U.S. food safety laws, and/or that import relatively low-
aspects of implementation to the Secretary’s discretion than
within 18 months of enactment: (1) to establish, in
risk foods, be permitted to fol ow abbreviated procedural
does the expedited import program proposed in S. 510. This
consultation with the Secretary of Homeland Security, a
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requirements? If so, what if any additional standards should
section authorizes the Secretary ( in coordination with
voluntary program to expedite review and importation of
they have to meet?
Customs and Border Protection) to establish a program to
foods from qualified importers; and (2) to issue applicable
facilitate the movement of food through the import process,
program guidance. An importer is defined in this section as
if the importer verifies that each facility involved in its
“the person that brings food, or causes food to be brought,
production, manufacture, processing, packaging, and holding
from a foreign country into the customs territory of the
is in compliance with safety and security guidelines that the
United States.” An importer that intends to participate in the
Secretary would develop (taking into account a number of
program under this section in a fiscal year shall submit a
prescribed factors). The importer also is to ensure that
notice to the Secretary of such intent at time and in a
appropriate safety and security controls are in place
manner established by the Secretary. Eligibility is limited to an
throughout the supply chain and to provide supporting
importer who offers for importation a food from a facility
information to the Secretary.
that has a certification under § 809(b), as established by this
act. The Secretary shall consider, in making such
determinations, the risk posed with respect to: (1) the nature
of the food; (2) the compliance history of the foreign
supplier; (3) the regulatory system of the country of export;
(4) the compliance of the importer with the requirements of
the foreign supplier verification program under § 805, as
established by this act; (5) recordkeeping, 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 shal promptly
revoke an importer’s qualified status if the importer is found
not to be in compliance. Making of false statements under
this authority may subject an importer to criminal fines
and/or imprisonment, pursuant to 18 U.S.C. § 1001.
INFANT FORMULA
FFDCA § 412 sets forth detailed requirements whereby
Infant Formula (§ 114)
No comparable provision.
manufacturers of infant formula are required to provide FDA
with assurances of the nutritional quality of their
Alters several requirements which apply to a manufacturer of
formulations before marketing the formula. FDA has
a new infant formula; e.g., FDA would have additional time to
requirements for certain labeling, nutrient content, quality
review certain safety information regarding new ingredients.
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.
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FOODBORNE ILLNESS SURVEILLANCE AND PUBLIC EDUCATION (See also “Foodborne Illness Surveillance and Outbreak Response” section of this report.)
Surveillance for foodborne illness is carried out by the states,
Surveillance (§ 121)
Surveillance (§ 205)
with assistance from the CDC. States also conduct
investigations of foodborne outbreaks, in coordination with
This section generally mirrors the language in § 205 of the
For the purposes of this section, “foodborne illness
CDC, either FDA or FSIS (depending on implicated or
Senate bill, but lacks two of the provisions: the requirement
outbreak” is defined as two or more cases of a similar illness
suspected foods), and, if appropriate, other federal agencies.
for a working group on foodborne illness surveillance; and
resulting from the ingestion of a certain food. This section
FDA is authorized to carry out such investigations, or to
the reauthorization of the food safety capacity grants.
requires the Secretary, acting through the Director of the
coordinate with states in doing so: (1) under broad,
CDC, to enhance foodborne illness surveillance systems by,
Public Education and Advisory System (§ 122)
permanent authorities in FFDCA § 702 regarding
among other things, enhancing system capacity; improving
examinations and investigations, and § 909 regarding
This section of the bill requires the Secretary, in cooperation
coordination and information sharing; incorporating research
authority to assist states with examinations and
with private, state and other public organizations, to design
findings; making surveillance data available to the public in
investigations; and (2) under several broad, permanent
and implement a national public education program on food
appropriate formats; and integrating systems and data with
disease control authorities of the Secretary of HHS in Title III safety. The section describes the elements to be included in
other biosurveillance and related federal, state and local
of the PHS Act, which underpin CDC’s activities as well.
the program, and further requires the Secretary to work
surveillance systems. Appropriations are authorized for these
These include PHS Act § 301 regarding research and
with states and others to develop and incorporate into the
activities at $24 million annually (FY2011-FY2015). The
investigations, §§ 311 and 317 regarding federal-state
public education program regional and national advisories
Secretary must also establish a working group, comprised of
cooperation, and § 361 regarding control of communicable
concerning food safety.
public- and private-sector experts and stakeholders, to meet
diseases. PHS Act § 317R provides an explicit but expired
and report at least annual y, and make recommendations for
authority of the Secretary to award grants to state and tribal
the improvement of foodborne illness surveillance systems.
governments to enhance food safety surveillance and
The Secretary shall, within one year of enactment, conduct
laboratory capacities. Although this authority has expired, the
an assessment of state and local food safety and defense
Secretary may carry out this activity under the broad,
capacities, and shall subsequently develop and implement
permanent authorities mentioned earlier.
strategies to enhance these capacities, in order to achieve a
A foodborne illness “outbreak” is not defined in law or
number of stated goals. This section also reauthorizes the
regulations. In public health practice, and as used by CDC, a
food safety capacity grants in PHS Act § 317R at $19.5 million
“foodborne disease outbreak” is defined as “the occurrence
for FY2010, and such sums as may be necessary for FY2011
of two or more cases of a similar illness resulting from the
through FY2015.
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. Exceptions may be made for serious
problems such as botulism.
RESEARCH
FDA, along with other federal agencies, is already involved in
Research (§ 123)
Food Safety Integrated Centers of Excellence (§ 210)
a variety of research activities, in such areas as how and
where food contamination occurs, biotechnology and
Requires the Secretary to conduct research to assist in
Section 210(b) of this section, regarding Food Safety
allergenicity issues, seafood safety, color additives, consumer
implementation of the Act, including studies to improve
Integrated Centers of Excel ence, which would, among other
studies, the detection, characterization, and behavior of
sanitation and food safety practices in food production,
things, conduct food safety research. Requires the Secretary
foodborne pathogens, for example. Col aborative research
harvesting, processing, develop improved monitoring and
and the CDC Director (in consultation with other groups) to
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Background, Applicable Current Law, and
Administration Statements
H.R. 2749 (House-passed)
S. 510 (Amendment)
efforts have been underway for some time with USDA’s
food inspection techniques, develop efficient and rapid
designate five “Integrated Food Safety Centers of Excellence”
Agricultural Research Service and National Institute of Food
methods for detecting the presence of food contaminants,
at selected state health departments to serve as resources
and Agriculture,, and with academia, state health and
among other specific areas of emphasis.
for federal, state, and local public health professionals.
agricultural officials, industry and others.
Authorizes the appropriation of such sums as necessary to
carry out this provision.
SEIZURE OF FOOD
FFDCA § 304 spells out the grounds, jurisdiction, and
Procedures for Seizure (§ 131)
No comparable provision.
procedures to be used to seize FDA-regulated products
through a court order. (This extensive FFDCA provision and
Appears to expedite the process for seizing adulterated or
the implementing steps involved are detailed in FDA’s
misbranded articles of food by altering the current statutory
Regulatory Procedures Manual.
procedures for doing so.
135)
ADMINISTRATIVE DETENTION OF FOOD
The Secretary has authority for the administrative detention of
Administrative Detention (§ 132)
Administrative Detention of Food (§ 207)
foods pursuant to FFDCA §§ 304(h) and 801. Under FFDCA §
304(h), an FDA officer or qualified employee may order the
Similar to the Senate measure, this section changes the
This section amends FFDCA § 304(h) in two ways. First, the
detention of an article of food for up to 30 days if the FDA
FFDCA § 304(h) requirement for “credible evidence or
requirement for “credible evidence or information” is
official “has credible evidence or information indicating that such
information” to “reason to believe” and changes the standard lowered to “reason to believe.” Second, the standard “a
article presents a threat of serious adverse health consequences
of “a threat of serious adverse health consequences or death
threat of serious adverse health consequences or death to
or death to humans or animals.” The detention request must be
to humans or animals” to “adulterated or misbranded,” and
humans or animals” is changed to “adulterated or
approved by the Secretary or the Secretary’s designated of icial.
also adds “or otherwise in violation of this Act.” Unlike S.
misbranded.” Thus, FFDCA § 304(h)(1)(A) would read: “An
Detention orders may be appealed to the Secretary.
510, the House bill extends the maximum period to detain an officer or qualified employee of the Food and Drug
article of food under § 304(h) from 30 days to 60 days;
Administration may order the detention ... of any article of
Under FFDCA § 801, FDA officers and qualified employees must
strikes a sentence regarding how a subsection may be
food that is found during an inspection, examination, or
request the Secretary of Homeland Security to hold food at the
construed regarding delivery of an article of food pursuant to
investigation under this Act conducted by such officer or
port of entry for up to 24 hours if they possess “credible
the execution of a bond while the food is subject to a
qualified employee, if the officer or qualified employee has
evidence or information indicating that an article of food
detention order; and extends the time al owed for the
reason to believe that such article is adulterated or
presents a threat of serious adverse health consequences or
Secretary to act after an appeal of a detention order has been misbranded.” Within 120 days of enactment, the Secretary
death to humans or animals,” and that of icer or qualified
filed from 5 days to 15 days. The Secretary is required to
shall issue an interim final rule to implement the amended
employee “is unable to inspect, examine, or investigate such
issue regulations or guidance to implement the amendments,
authority, and the amendments to FFDCA § 304(h) shal be in
article upon the article being offered for import.” The request to
and the amendments shall take effect 180 days after
effect 180 days after enactment.
hold the food must be approved by the HHS Secretary or his or
enactment.
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.”

135 See http://www.fda.gov/ICECI/ComplianceManuals/RegulatoryProceduresManual/default.htm.
CRS-76

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 (Amendment)
Obama Administration: The Hamburg and Taylor
testimonies express support for § 132 of the House bill.
QUARANTINE AUTHORITY
The seizure provisions of FFDCA § 304 do not appear to
Authority to Prohibit or Restrict the Movement of
No comparable provision.
specifically authorize geographical quarantines of an article of
Food (§ 133)
food in the United States.
Amends FFDCA § 304 (seizure section) by adding that where
On occasion, FDA does subject certain imports or groups of
the Secretary, after consulting with the Governor or other
imports from an entire country or region to “detention
appropriate state elected official, “determines that there is
without physical examination” until the importer can
credible evidence or information that an article of food
demonstrate that the product satisfies FDA requirements.
presents an imminent threat of serious adverse health
Examples of this in 2007 were imports of all Chinese plant
consequences or death to humans or animals,” the Secretary
protein products (including wheat gluten and rice gluten)
is authorized to prohibit or restrict the movement of the
after some were found to contain melamine, an unapproved
article of food within the state or a portion of it. The
substance; and of al farm-raised shrimp, catfish, basa, dace,
Secretary must determine that “there is no less drastic action
and eel from China until the shippers of these products could that is feasible and that would be adequate to prevent the
demonstrate that they were free of unapproved drug
imminent threat of serious adverse health consequences or
residues.
death to humans or animals.”
Violation of a prohibition or restriction is a prohibited act
under FFDCA § 301. The remainder of § 133 describes the
notification procedures the Secretary must fol ow (including
public announcement and publication in the Federal Register)
for such a prohibition or restriction, requires renewal every
14 days, and includes limitations on the ability to delegate
quarantine authority to others.
CRIMINAL PENALTIES (See also “Criminal Penalties” section of this report.)
Under FFDCA § 301(a) (as adjusted by 18 U.S.C. §§ 3559 and
Criminal Penalties (§ 134)
No comparable provision.
3571) the maximum criminal penalty for individuals convicted
of a misdemeanor under the act is $100,000 if it does not
Any person who knowingly violates specified prohibited acts
result in death; $250,000 if it results in death; and/or
under FFDCA § 301 would be subject to increased penalties,
imprisonment of one year. The maximum criminal
of up to 10 years in prison and/or fines in accordance with
misdemeanor penalty for organizations (as adjusted by 18
the U.S. Criminal Code (Title 18 of the U.S.C.). This section
U.S.C. §§ 3559 and 3571) is $200,000 if the offense does not
also requires the revision of penalties for violations of the
result in death and $500,000 if the offense results in death.
FFDCA.
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
CRS-77

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 (Amendment)
for organizations (as adjusted by 18 U.S.C. §§ 3559 and 3571)
is a fine of not more than $500,000.
Obama Administration: The Hamburg and Taylor
testimonies express support for § 134 of the House bill.
CIVIL PENALTIES
FFDCA § 303(f)(2) FFDCA subjects any person who
Civil Penalties for Violations Relating to Foods (§
No comparable provision.
“introduces into interstate commerce or delivers for
135)
introduction into interstate commerce an article of food that

is adulterated within the meaning of [FFDCA] section
Amends FFDCA § 303(f)(2) ) to delete restrictions on civil
402(a)(2)(B)” to a civil monetary penalty of up to $50,000 if
penalty provisions regarding pesticide chemical residues that
an individual and up to $250,000 on any other person, to a
result in a food being deemed adulterated under FFDCA §
maximum of $500,000 for al such violations adjudicated in a
402(a)(2)(B). It also amends § 303(f)(2) by authorizing the
single hearing. However, 402(a)(2)(B) applies only to the
Secretary to assess a civil penalty of up to $20,000 (not to
presence of illegal pesticide residues. The section further
exceed $50,000 in a single proceeding) on an individual and
exempts from this penalty any person who grew the article
of up to $250,000 on any other person (not to exceed $1
of food, and it prohibits use of FDA’s seizure, injunction, or
million in a single proceeding) for committing a violation of
criminal authorities if such a civil monetary penalty is
FFDCA § 301 (prohibited acts). For knowing violations,
assessed.
maximum civil penalties for individuals are $50,000 (not to
exceed $100,000 in a single proceeding), and for any other
Currently, there are no maximum civil penalties tied to
person $500,000 (not to exceed $7.5 million in a single
FFDCA § 303(a), which addresses criminal penalties for
proceeding). Each prohibited act and each day is to be
prohibited acts under the FFDCA.
considered a separate offense. The rewording of this section
appears to effectively broaden the reasons for which civil
Obama Administration: The Hamburg and Taylor
penalties could be applied; subjects those growing an article
testimonies express support for § 135 of the House bill.
of food that is adulterated under § 402(a)(2)(B) to them; and
appears to no longer preclude use of seizure, injunction, or
criminal authorities with regard to violations of §
402(a)(2)(B). It does not strike § 303(f)(2)(C) regarding
hearings on the assessment of civil penalties.
IMPORT ENTRY FILINGS (See also “Food Imports” section of this report, and 80 row of this table.)
The FFDCA does not require those who are importers or
Improper Import Entry Filings (§ 136)
No comparable provision.
import brokers to register with FDA under the food facility
registration provisions of § 415.
This section amends FFDCA § 801 (imports and exports) by
authorizing the Secretary to require by regulation or
guidance the submission of documentation (in certain
circumstances, in consultation with Customs and Border
Protection) or other information for articles of food that are
imported or offered for import into the United States.
Failure to submit required information, submission of
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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 (Amendment)
inaccurate or incomplete information, is prohibited under
FFDCA § 301.
FOOD SUBSTANCES GENERALLY RECOGNIZED AS SAFE (GRAS)
This issue revolves around FDA’s exercise of so-called
Food Substances Generally Recognized As Safe (§
No comparable provision.
“generally recognized as safe” (GRAS) determinations. Under
201)
current law, substances which FDA agrees are GRAS are
exempt from the much more rigorous premarket approval
Requires the Secretary to publish within 60 days on the FDA
process required for other food additives. Under a 1997
public website, notice of receipt of a request for a substance
proposed rule, FDA proposed creating a notification
to be determined by the Secretary to be General y
procedure for GRAS substances through which
Recognized As Safe (GRAS), and supporting scientific
manufacturers can notify the FDA of their “determination
justifications, among other provisions. This section does not
that a particular use of a substance is GRAS,” thereby
appear to address the GRAS notification procedure, as it
bypassing the regular federal rulemaking procedures. In fact,
discusses requests for substances to be determined by the
FDA has been using this GRAS notification procedure since
Secretary to be GRAS. In the notification procedure, the
the publication of the proposed rule on an “interim policy”
manufacturer or other individual makes the conclusion that
basis.
the substance is GRAS and the FDA states that it has “no
questions” about this conclusion, that the notice does not
provide a basis for a GRAS status determination, or that the
individual has stopped the GRAS notification process.
COUNTRY OF ORIGIN LABELING (COOL)
Since the 1930s, § 304 of the Tariff Act of 1930, as amended,
Country of Origin Labeling (§ 202)
No comparable provision.
has required most imports to carry labels so that the
"ultimate purchaser," usually the retail consumer, can
Amends the misbranding provision of FFDCA § 403 to
determine their country of origin. Certain products, including consider a processed food misbranded if its label fails to
a number of agricultural commodities in their "natural" state
identify the country in which final processing occurred. A
such as meats, fruits and vegetables, were excluded. Effective
non-processed food is misbranded if its label fails to identify
in 2009, many retail food stores are now required to inform
the country of origin. Processed foods and non-processed
consumers about the country of origin of fresh fruits and
foods are deemed to meet the requirements of this section if
vegetables, seafood, peanuts, pecans, macadamia nuts,
they are subject to and meet the requirements of,
ginseng, and ground and muscle cuts of beef, pork, lamb,
respectively, the U.S. Customs and Border Protection or
chicken, and goat, under provisions of the 2002 farm bill (P.L.
USDA. The Secretary is required to promulgate final
107-171) as amended by the 2008 farm bill (P.L. 110-246).
regulations on this provision within 180 days of enactment,
and the new requirements take effect two years after
The FFDCA does not expressly require country-of-origin
enactment.
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.
CRS-79

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 (Amendment)
EXPORT CERTIFICATION FEES

Exportation Certificate Program (§ 203) is discussed
Authority to Collect Fees (§ 107) is discussed under
under the “Funding and Fees” section.
“Funding and Fees” above.
FOREIGN SUPPLIER VERIFICATION (See also “Mandatory Recall Authority” and “Food Imports” sections of this report, and 78 row of this table.)
The FFDCA does not explicitly authorize, and does not
Registration for Commercial Importers of Food; Fee
Foreign Supplier Verification Program (§ 301)
require, the establishment of a foreign supplier verification
(§ 204); Registration for Customs Brokers (§ 205);
program. The FFDCA also does not require those who are
Unique Identification Number for Food Facilities,
Amends FFDCA Chapter VIII (regarding imports and
importers or import brokers to register with FDA under the
Importers and Customs Brokers (§ 206)
exports) by adding a new § 805, effective two years after the
food facility registration provisions of § 415. At a House
date of enactment, requiring each importer to establish risk-
Energy and Commerce Committee hearing on June 3, 2009,
These sections require an importer of foods to register
based foreign supplier verification activities. Importing, or
U.S. officials acknowledged that they had no firm data on the
annual y with the Secretary and to submit an appropriate
offering for importation, a food by an importer who does not
number of entities that import food.
unique facility identification as a condition of such
have such a program in place is prohibited under FFDCA §
registration. Further conditions for importers (but not
301, and the Secretary shal refuse admission to any such
Obama Administration: The Hamburg and Taylor
customs brokers) include compliance with “good importer
product that appears to be in violation of this requirement.
testimonies express support for § 204 of the House bill.
practices.” Among other provisions in this section is a
Defines an importer as the U.S. owner or consignee of the
requirement that importers permit an officer or employee of
article of food at the time of entry of such article into the

the Secretary to “inspect the facilities of such person and
United States; or the United States agent or representative of
have access to, and to copy and verify, any related records.”
a foreign owner or 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)
importer must take to ensure that the importer has adequate assures that imported food is not adulterated or misbranded;
information about a food, its hazards, and applicable
and (2) complies with the program of hazard analysis and
requirements; the ability to verify that both the food and
preventive controls in FFDCA § 418, or the produce safety
each person who produced, manufactured, processed,
requirements in FFDCA § 419, each as established by this act.
packed, transported, or held the food including its
Within one year of enactment, the Secretary shall issue
components are in compliance; and procedures to take
guidance and promulgate regulations regarding the
corrective actions regarding noncompliant foods. This
development of foreign supplier verification programs,
provision also authorizes the Secretary, in promulgating good including appropriate verification steps that importers may
import practices regulations, to incorporate certification of
apply to the products of their foreign suppliers, to assure that
compliance under FFDCA § 801(q) and participation in the
safety requirements are met. The importer shall maintain
safe and secure food importation program under FFDCA §
appropriate documentation for not less than two years, and
805, and to take into account differences among importers
make such records available for inspection. Importers of
and types of imports.
seafood, juice, or low-acid canned food whose products are
currently in compliance with FDA’s relevant standards and
Provisions in this part of the bill provide for conditions for
regulations are deemed to be compliant with this section.
suspending registrations, and for exemptions from the
The Secretary shal 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
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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 (Amendment)
misbranded under FFDCA § 403. Fees must be charged to
importers (but apparently not customs brokers, even though
“Fee” was in the title of § 205 marked up in committee).
Improper Import Entry Filings (§ 136)
As previously noted, this section amends FFDCA § 801
(imports and exports) by authorizing the Secretary to require
by regulation or guidance the submission of documentation
(in certain circumstances, in consultation with Customs and
Border Protection) or other information for articles of food
that are imported or offered for import into the United
States. Failure to submit required information, submission of
inaccurate or incomplete information, is prohibited under
FFDCA § 301.
INSPECTION OF FOREIGN FACILITIES (See also “Targeting of Inspections” section of this report, and 59, 69, 66 and 94rows of this table.)
FFDCA § 704 authorizes officers and employees designated
Prohibition Against Delaying, Limiting, or Refusing
Inspection of Foreign Food Facilities (§ 306)
by the Secretary of HHS to, among other things, enter and
Inspection (§ 207); Risk-Based Inspection Schedule (§
inspect “any factory, warehouse, or establishment in which
105)
Amends FFDCA Chapter VIII (regarding imports and
food, drugs, devices, or cosmetics are manufactured,
exports), adding a new § 807, authorizing the Secretary to
processed, packed, or held, for introduction into interstate
Amends FFDCA § 402 by newly considering a food
enter into arrangements and agreements with foreign
commerce or after such introduction.” Inspections must be
adulterated if it is from any farm, factory, warehouse, or
governments to facilitate the inspection of foreign facilities
conducted “at reasonable times and within reasonable limits
establishment and the owner, operator, or agent,” or any
registered under FFDCA § 415; and requiring the Secretary
and in a reasonable manner.” The refusal to permit such
agent of a governmental authority in the foreign country,
to direct resources to inspections of foreign facilities,
inspections is prohibited under FFDCA § 301. “Interstate
“delays or limits an inspection or refuses to permit entry or
suppliers, and food types, especially such facilities, suppliers,
commerce” is defined under FFDCA § 201 to mean “(1)
inspection” under FFDCA § 414 (records inspection) or §
and food types that present a high risk (as identified by the
commerce between any State or Territory and any place
704 (factory inspection). (The remainder of the bill’s § 203
Secretary), to help ensure the safety and security of the food
outside thereof, and (2) commerce within the District of
consists of similar proscriptions for drugs, devices, and
supply of the United States.
Columbia or within any other Territory not organized with a
cosmetics.)
Imported foods shall be refused admission if “from a foreign
legislative body.” A “factory, warehouse, or establishment” is
The general risk-based inspection provisions in § 105 (above)
factory, warehouse, or other establishment of which the
not defined in the FFDCA; nor does there appear to be any
apply to both imported and domestic inspections. As noted
owner, operator, or agent in charge, or the government of
statutory distinction here between foreign and domestic.
above, §105 requires foreign facilities to be inspected by an
the foreign country, refuses to permit entry of United States
Although the FFDCA appears neither to expressly include
agency or representative of a foreign country that is
inspectors or other individuals duly designated by the
nor to expressly exclude foreign facilities with regard to the
recognized by the Secretary as meeting U.S. standards. (See
Secretary, upon request, to inspect such factory, warehouse,
right of inspection by the HHS Secretary or designee, the
also § 208 of the House bill, below.)
or other establishment,” if an inspection is refused “during
Bush Administration had argued that FDA lacks the authority
the 24-hour period after such request is submitted, or after
to refuse food imports when the agency has been denied
Risk-Based Inspection Schedule (§ 105, part);
such other time period, as agreed upon by the Secretary and
access to a foreign facility.
Certification and Accreditation (§ 109, part)
the foreign factory, warehouse, or other establishment.’’
Note: Whether FDA now has what is often called
The Secretary has authority under § 105 (Risk-Based
The Secretary of Commerce, in coordination with HHS, may
“equivalency authority” is a matter of debate. “In a May 9,
Inspection Schedule) to “recognize Federal, State, and local
send one or more inspectors to a country or facility of an
officials and agencies and representatives of foreign countries
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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 (Amendment)
2007 hearing before the House Agriculture Committee,
as meeting standards established by the Secretary for
exporter of seafood imported to the United States. The
FDA’s chief food officer, David Acheson, responded to a
conducting inspections” under the FFDCA (recognition for
inspection will assess the practices used in connection with
question that the agency theoretical y has the authority to
such inspections could be limited to specific commodities or
the farming, cultivation, harvesting, preparation for market,
require equivalency for imports but that FDA’s situation is
food types); and under § 109 (accreditation of third-party
transportation of the seafood; technical assistance may be
significantly more complex than USDA’s.... [The Government
certifying agents), whereby a foreign government may be
provided for such activities. The Secretary, coordinating with
Accountability Office] had suggested in 1998 that border
eligible to be a qualified certifying agent.
the Secretary of Commerce, shall prepare an inspection
inspections alone were ineffective, but that FDA lacks the
report, which will also be provided to the exporter who will
authority to mandate equivalency.” However, FDA has visited Before requiring certification under § 109, (see above), the
be given 30 days to provide a rebuttal or comments to HHS.
certain importing countries at their invitation to conduct
Secretary must establish a process for a country or territory
such reviews, suggesting that current authority does not bar
to demonstrate that its controls are adequate to ensure that
the Secretary from conducting such assessments.
a food destined for the United States is safe. The Secretary
cannot require a certification for a food from a country or
FSIS has import equivalency authority, in that most meat,
territory that has made such a demonstration. The
poultry, and processed egg products may only be imported
application of these certification requirements must be
from countries that have demonstrated to FSIS that they
consistent with U.S. international obligations.
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.”
CRS-82

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 (Amendment)
FDA FOREIGN OFFICES
The FFDCA neither prohibits nor requires the establishment
Dedicated Foreign Inspectorate (§ 208)
Foreign Offices of the Food and Drug Administration
of FDA field offices in other countries. FDA reports that it is
(§ 308)
establishing offices in China, Latin America, India, Europe, and Amends FFDCA § 704 (in the General Authority chapter) to
the Middle East, and was implementing a Memorandum of
require the Secretary to establish and maintain a corps of
The Secretary is required, in consultation with the
Agreement with China, in order to coordinate food safety
inspectors dedicated to inspecting foreign food facilities. This
Secretaries of State and Homeland Security and the United
activities.
corps is to be staffed and funded at a level to assist the
States Trade Representative, to establish FDA offices in
Secretary to achieve the frequency of inspections for food
foreign countries selected by the Secretary, to assist the
facilities described in this Act.
appropriate governmental entities of those countries
regarding measures to provide for the safety of food and
other FDA-regulated products exported by those countries
to the United States. FDA activities may include the conduct
of risk-based inspections of such products, and supporting
such inspections by the governmental entity. The Secretary
shal report to Congress by October 1, 2011, with respect to
the selection of specific countries, the progress of the
established offices in assisting those foreign governments, and
plans to establish additional foreign offices. Clarifies that
nothing in this provision shall affect the Secretary’s authority
to issue public notifications under other circumstances.
OTHER LABORATORY PROVISIONS
Several national networks of laboratories are currently in
Plan and Review of Continued Operation of Field
Integrated Consortium of Laboratory Networks (§
operation. None is explicitly authorized in law. Existing
Laboratories (§ 209)
203)
networks include: the Laboratory Response Network (LRN),
run by CDC and federal and state partner groups to conduct
The House bill contains no provision comparable to the
The Secretary of Homeland Security, in consultation with the
public health testing during emergencies; the Food
integrated consortium provision in S. 510. § 209 does require Secretaries of HHS and USDA and the EPA Administrator,
Emergency Response Network (FERN), coordinated by FDA;
the Secretary to submit, to Congress and the Comptrol er
shall maintain an agreement whereby relevant laboratory
and the National Animal Health Laboratory Network,
General, a reorganization plan at least 90 days prior to
network members: (1) agree on common laboratory
coordinated by USDA.
terminating or consolidating any of the 13 field laboratories
methods to facilitate information sharing regarding animal
responsible for analyzing food that are operated by FDA’s
health, agriculture, and human health; (2) identify the means
Obama Administration: Its FY2010 budget requested an
Office of Regulatory Affairs, or terminating or consolidating
by which each laboratory network member could work
increase in the number of chemical laboratories under FERN
any of the 20 district offices with responsibility for food
cooperatively to optimize national laboratory preparedness
through cooperative agreements, and to invest in FDA high-
safety. This section also subjects such a reorganization plan to and provide surge capacity during emergencies; and (3)
volume laboratories for better sample analyses and faster
the requirements of the Congressional Review Act (5 U.S.C.
engage in ongoing dialogue and build relationships to support
testing. The administration proposed retaining the FY2010
§§ 801-808), which establishes a special set of expedited or
a more effective and integrated response during emergencies.
level for FY2011.
“fast track" legislative procedures, primarily in the Senate,
The Secretary of Homeland Security shall publish and report
through which Congress may enact joint resolutions
biennial y to Congress on the progress of this integrated
disapproving agencies' final rules.
consortium.
CRS-83

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 (Amendment)
FALSE OR MISLEADING REPORTING TO FDA
FFDCA § 301delineates prohibited acts under the law, one of
False or Misleading Reporting to FDA (§ 210)
No comparable provision.
which is “With respect to any device, the submission of any
report that is required by or under this Act that is false or
Expands the FDA-regulated products covered by this
misleading in any material respect.” [§ 301(q)(2)].
prohibited act to include a “food, drug, or biological product.”
FDA SUBPOENA AUTHORITY
The FFDCA provides authority for issuing subpoenas under
Subpoena Authority (§ 211)
No comparable provision.
certain specified conditions. For example, in the course of an
investigation or hearing leading to either civil penalties or
Expands subpoena authority by permitting the FDA
withdrawal of approval for violations of the law related to
Commissioner to issue subpoenas for witnesses and “the
drug applications under §§ 335(b) and 335(c), the Secretary is
production of records and other things” for the purpose of
authorized, among other things, to issue subpoenas requiring
any hearing, investigation, or other proceeding on a violation
attendance of witnesses and production of evidence. Similar
of the FFDCA. This section contains extensive language on
authorities are provided regarding violations related to
the timing of compliance and service of a subpoena, among
devices under § 333(f), and regarding debarment proceedings
other t
for certain drug applications and for food imports (i.e.,
hings.
preventing entry of a food import), under § 335(a).
WHISTLEBLOWER PROTECTION
A variety of federal and state measures have been adopted to Whistleblower Protections (§ 212)
Employee Protections (§ 402)
protect so-called whistleblowers, or those employees who
disclose information about illegal or improper activity,
Creates a new FFDCA § 911, “Protections for Employees
Creates a new FFDCA § 1012 prohibiting food businesses
general y at their place of employment. Many federal
Who Refuse to Violate, or Who Disclose Violations of, This
from discharging or otherwise discriminating against an
employees, for example, are covered by the Whistleblower
Act or Section 351 of the Public Health Service Act.”
employee who provides or causes to be provided
Protection Act (P.L. 101-12). The FFDCA itself contains no
Extensive language here makes it illegal to “discharge,
information relating to violations of the FFDCA; who
such language regarding a private employee who must, or
demote, suspend, threaten, harass, on in any other manner
testifies, assists, or participates in a proceeding on such a
willingly provides, information related to an FDA-related
discriminate against an employee in the terms and conditions
violation; or who refuses to participate in an activity
product.
of employment” if such an employee provides information on
reasonably believed to violate the act. Contains extensive
a food, relating to a possible violation of the FFDCA or the
(but different from House) language on the procedures for
Public Health Service Act.
treating and protecting whistleblowers.
See 52 above for § 213 of H.R. 2749 regarding extraterritorial jurisdiction.
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S. 510 (Amendment)
STATE AND LOCAL FOOD SAFETY ROLES AND TRAINING
Although federal agencies such as the FDA and FSIS have
Support for Training Institutes (§ 214)
Improving the Training of State, Local, Territorial,
national responsibility for food safety under their respective
and Tribal Food Safety Officials (§ 209)
authorizing statutes, state and local food safety agencies
Requires the Secretary to provide financial and other
(usually located within health, agriculture, or environment
assistance to appropriate entities to establish and maintain at
Creates a new FFDCA § 1011 which requires the Secretary
departments) have long played major, and in some cases lead, least one university-affiliated institute to train federal, state
to set standards and administer training and education
roles, with responsibility for illness surveillance, response to
and local officials in food protection activities.
programs for employees of state, local, territorial, and tribal
local outbreaks, and inspection and oversight of food safety
food safety authorities relating to their responsibilities under
and local public health laws in restaurants and grocery stores.
the FFDCA, and authorizes the Secretary to enter into
Often these activities may be conducted in col aboration, or
examination, testing, and investigations partnerships with
under contract, with federal authorities. Notable examples
such officials and their employees.
include the Grade A Pasteurized Milk Ordinance and the
The Secretary shall coordinate with USDA’s extension
National Conference of Interstate Milk Shipments (where
activities of the National Institute of Food and Agriculture
federal authorities collaborate with state authorities and the
(NIFA) in advising producers and smal processors of new
milk industry to ensure the safety of milk shipped in
requirements under this act. Also, the Secretary, within 180
interstate commerce), the National Shel fish Sanitation
days of enactment, shal enter into agreements with the
Program (a federal-state program to ensure the safety of
Secretary of Agriculture to provide competitive training and
shellfish), and FDA-state contract inspection agreements
technical assistance grants, through NIFA, for farmers, smal
(where states conduct facility inspections for FDA).
food processors, and smal fruit and vegetable merchant
Currently no specific legislative language authorizes support
wholesalers, in accordance with § 405 of the Agricultural
for a training institute. FDA does provide funding to state and
Research, Extension, and Education Reform Act of 1998
local agencies through various grants and cooperative
(AREERA), as established by this act (see below). There are
agreements to help them conduct such activities as food
authorized to be appropriated for new FFDCA §1011 such
defense, laboratory improvements, and food safety training;
sums as necessary for FY2011-FY2015.
this funding totaled approximately $11.4 million in FY2008
Creates a new AREERA § 405, “National Food Safety
and was in addition to an estimated $8 million states received
Training, Education, Extension, Outreach and Technical
for FDA contracts to conduct food inspection that year.136
Assistance Program.” The Secretary of Agriculture shall,
through NIFA, award competitive grants to carry out the
program authorized above, as specified. Priority shall be given
to projects for smal and medium-sized farms, beginning
farmers, social y disadvantaged farmers, smal processors, or
smal fresh fruit and vegetable merchant wholesalers. Grants
are limited to terms of not more than three years. Eligible
entities are (1) a state cooperative extension service; (2) a
federal, state, local, or tribal agency, a nonprofit community-

136 Source: Stronger Partnerships for Safer Food: An Agenda for Strengthening State and Local Roles in the Nation’s Food Safety System, at http://www.rwjf.org/files/research/
20090417foodsafetyfinalreport.pdf.
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S. 510 (Amendment)
based or non-governmental organization, or an organization
representing owners and operators of farms, smal food
processors, or smal fruit and vegetable merchant
wholesalers that meet specified requirements; (3) an
institution of higher education (as defined) or a foundation
maintained by such institution; (4) a collaboration of 2 of
more eligible entities; or (5) other entities as determined by
the Secretary. Grants may be made to projects involving
more than one state. The Secretary may issue best practices
or other guidelines based on findings from this grant
program. There are authorized to be appropriated for new
AREERA § 405 such sums as necessary for FY2011-2015.
Enhancing Food Safety (§ 210)
Subsection (a) of this section replaces FFDCA § 1009,
regarding grants to states for inspections. New language
would authorize grants to states, localities, territories, Indian
tribes, and certain non profit entities, to be used for:
undertaking food safety examinations, inspections and
investigations; training to the Secretary’s standards for
conducting such activities; and building laboratory capacity,
among other things. Sets out eligibility and application
requirements and procedures; authorizes appropriation of
such sums as necessary for grants from FY2011-FY2015.
Requirements for eligible entities are specified, including
maintenance of effort with respect to grantee funding
contributions. Also, the Secretary shal measure the status
and success of each grant program, based on information
provided by recipients of how grant funds were spent and
the status of their efforts.
Subsection (b) of this section requires the Secretary and the
CDC Director (in consultation with other groups) to
designate five “Integrated Food Safety Centers of 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.
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S. 510 (Amendment)
BISPHENOL A (BPA) (See also “Bisphenol A (BPA)” section of this report.)
Bisphenol A (BPA) is used to produce certain types of plastic, Bisphenol A in Food and Beverage Containers (§ 215) No comparable provision.
including food containers. In the United States and elsewhere,
scientific disagreement about the possibility of human health
Requires the Secretary to notify Congress by December 31,
effects that may result from BPA exposure through food and
2009 on whether available scientific data support “a
water has led to conflicting regulatory decisions regarding the determination that there is a reasonable certainty of no
safety of food containers, especial y those intended for use by harm, for infants, young children, pregnant women, and
infants and children.
adults, for approved uses” of plastics made with BPA in food
and beverage containers. If such a determination cannot be
BPA-containing PC polymers and epoxy resins used in food
made for any use, the Secretary must inform Congress on
containers—such as baby bottles and infant formula cans,
what actions will be taken to protect public health.
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.
LEAD IN CERAMICS
Pursuant to its FFDCA authority, FDA regulates food contact Lead Content Labeling Requirement for Ceramic
No comparable provision.
surfaces as well as food. The FDA has standards regarding
Tableware and Cookware (§ 216)
the leaching of lead from ceramics that are to be used for
food. These are at “Compliance Policy Guide (CPG) Sec.
Would deem ceramic tableware and cookware misbranded
545.450 Pottery (Ceramics); Import and Domestic—Lead
under the FFDCA if it includes a glaze or decorations
Contamination” (CPG 7117.07).
containing lead for an intended functional purpose, unless
either: it and its package bears statement: “This product is
made with lead-based glaze consistent with FDA guidelines
for such lead”; or [sic] the product is in compliance with FDA
requirements applicable to ornamental and decorative
ceramic ware. Further requires the Secretary to educate
consumers on the safety of ceramic ware for food use.
PROVISIONS ACCORDING TO SECTIONS IN S. 510 THAT HAVE NOT ALREADY BEEN PRESENTED, IN NUMERICAL ORDER
INTENTIONAL ADULTERATION AND DOMESTIC FOOD DEFENSE
Intentional adulteration of foods can occur due to terrorism
Hazard Analysis, Risk-Based Preventive Controls,
Protection Against Intentional Adulteration (§ 106)
or out of economic motivation. Examples of the latter include Food Safety Plan, Finished Product Test Results from
findings in early 2007 of melamine in pet food ingredients
Category 1 Facilities (§ 102)
Subsection (a) of this section establishes a new FFDCA § 420,
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S. 510 (Amendment)
from China. Melamine—apparently added to boost the
Subsection (c) of this section establishes a new FFDCA §
requiring the Secretary, within 18 months of enactment, in
ingredients’ protein readings—sickened or killed many dogs
418C, Food Defense, requiring the owner, operator, or agent coordination with the DHS and in consultation with USDA,
and cats in North America. The ingredients subsequently
of a facility to develop and implement a written food defense
to promulgate regulations to protect against the intentional
were found in some hog, chicken, and fish feed. Although a
plan before introducing any shipment of food into interstate
adulteration of food subject to this act. Regulations shal
risk assessment by FDA and USDA indicated the problem
commerce. Lists required elements of the plan, including an
apply only to food: (1) for which the Secretary has identified
posed virtually no risk to humans, melamine turned up again
assessment to identify conditions and practices that may
clear vulnerabilities; and (2) that is in bulk form rather than
in 2008 in milk products, milk-derived ingredients, and
permit a hazard to be intentionally introduced, a description
final packaging. To make such determinations, the Secretary
finished food products containing milk from China.
of preventive measures to minimize such risks and of
shall conduct vulnerability assessment of the food system
(including consideration by DHS), considering uncertainties,
FFDCA § 801(h) and (i), regarding imports and exports,
corrective actions to be taken if necessary, and other
risks, costs, benefits, available mitigation strategies, and other
require the Secretary to increase the number of import
elements.
factors. This section shal not apply to food produced on
inspections, giving greatest priority to the detection of
Defines “hazard” for the purposes of this section. Authorizes
farms, except for milk. Failure to comply with the
intentional adulteration of food, and to improve information
the Secretary to require by regulation or guidance the
requirements of this subsection is prohibited.
management systems and develop rapid detection methods
adoption of preventive measures for specific product types;
to serve this purpose. FDA’s current food regulations do not
al ows for alternative measures to be approved by the
Subsection (b) of this section requires the Secretary, within
specifically address intentional contamination of foods. FDA
Secretary; contains a number of reassessment, plan revision,
one year of enactment, to issue appropriate guidance
has published some guidance documents regarding protection recordkeeping, and records access requirements similar to
regarding the requirements of this section, and authorizes the
of the food supply from intentional contamination. The
those that facilities must follow under this section of the bill
Secretary, in coordination with the Secretaries of DHS and
agency also has an internal work group on intentional
when developing and implementing hazard prevention plans
USDA, to issue guidance documents related to protection
economic adulteration and conducted, on May 1, 2008, a
for unintentional contamination.
against intentional food adulteration. These guidance
public meeting on the issue.
documents and the vulnerability assessment of the food
system may require limited distribution due to national
There is currently no statutory requirement for the
security concerns. The Secretary will periodically review
development of a comprehensive agriculture and food
required regulations and guidance required by this section,
defense strategy. There are, however, other examples of
and update them if needed.
required, comprehensive, quadrennial reviews of this type.
The Quadrennial Defense Review is perhaps the best-known
National Agriculture and Food Defense Strategy (§
example. The Implementing Recommendations of the 9/11
108)
Commission Act of 2007 (P.L. 110-53) requires the Secretary
of the Department of Homeland Security (DHS) to routinely
Within one year of enactment, the Secretary and the
conduct a Quadrennial Homeland Security Review, beginning
Secretary of Agriculture, and in consultation with the
in FY2009. The Pandemic and Al -Hazards Preparedness Act
Secretary of Homeland Security, shal prepare a National
(P.L. 109-417, December, 2006) requires the Secretary of
Agriculture and Food Defense Strategy, to be submitted to
HHS to routinely prepare a quadrennial National Health
relevant congressional committees and made public on
Security Strategy and implementation plan, beginning in 2009.
USDA and HHS websites (in a manner consistent with
national security interests). The strategy shall include an
“In November 2002, Congress passed legislation creating
implementation plan and a research agenda, and be consistent
[DHS]. Among its responsibilities is overall coordination of
with the National Incident Management System; the National
critical infrastructure protection activities....In June 2006, the
Response Framework; the National Infrastructure Protection
Bush Administration released a National Infrastructure
Plan; the National Preparedness Goals; and other relevant
Protection Plan. This Plan presents the process by which the
national strategies. The strategy must be revised at least
Department of Homeland Security intends to identify those
every four years. The strategy shal describe the process by
specific assets most critical to the United States, across all
which HHS, DHS, and USDA will achieve a set of goals laid
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S. 510 (Amendment)
sectors, based on the risk associated with their loss to attack
out in this act, and evaluate the progress made by federal,
or natural disaster, and then to prioritize activities aimed at
state, local, and tribal governments towards achieving those
maximizing the reduction of those risks for a given
goals. The act lists 17 specific goals, covering preparedness,
investment.” (CRS Report RL 30153, Critical Infrastructures:
detection, emergency response, and recovery.
Background, Policy, and Implementation, by John D. Moteff.)
At present, DHS has identified several critical infrastructure
Food and Agriculture Coordinating Councils (§ 109)
and key resources sectors, including “Agriculture and Food.”
Requires the Secretary of Homeland Security, in coordination
For each sector, a Government Coordinating Council and a
with the Secretaries of HHS and Agriculture, within 180 days
(private) Sector Coordinating Council have been established
of enactment and annually thereafter, to report on the
to share data and best practices, and to support risk-based
activities of the Food and Agriculture Government
planning.
Coordinating Council and the Food and Agriculture Sector
With regard to building domestic capacity, in general,
Coordinating Council, regarding their progress in facilitating
requirements in this section are not explicit in current law,
public-private partnerships; facilitating information exchange;
but the Secretary would not be prohibited from undertaking
developing best practices for coordinated preparedness and
these assessments and reporting the findings.
response; and means to protect the U.S. economy and public
health in the event of a food or agricultural incident.
FDA has initiated a number of activities focusing on economic
adulteration of foods and other products it regulates,
Building Domestic Capacity (§ 110)
including the establishment of an internal working group.
Establishes a number of assessment and reporting
requirements regarding domestic capacity to prevent or
address food safety threats, as follows:
Within two years of enactment, the Secretary (in
coordination with USDA and DHS) must report to Congress
regarding measures to promote food safety and supply chain
security, and prevent foodborne illness outbreaks, covering
certain identified areas. In preparing the initial report, the
Secretary shall describe ways to improve laboratory
capability and capacity, information systems, risk assessment
systems for food, and include an analysis of FDA’s handling of
foodborne outbreaks during the five years prior to
enactment that involved fruits and vegetables that are raw
agricultural commodities, as defined in FFDCA § 201(r).
HHS and USDA shall, biennially, submit to Congress a joint
food safety and food defense research plan, which may
include studying the long-term health effects of foodborne
illness. The plan shall include a list and description of projects
conducted during the previous two-year period, and the plan
for projects to be conducted in the following two years.
HHS shall, annually, submit to Congress an evaluation of the
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S. 510 (Amendment)
effectiveness of each HHS-administered program. The
evaluation will assess each program’s effectiveness in
achieving “legislated intent, purposes, and objectives,” and
will include recommendations for consolidation and
elimination to reduce duplication and inefficiencies. The
report will be made publicly available. (Note: The language of
this provision is not limited to food safety programs.)
Not later than one year after enactment, the Secretary shal
conduct a study of issues associated with developing and
implementing a program that requires “unique identification
numbers” for each food facility registered with FDA and for
each broker that imports to the United States. A report to
Congress on “unique identification numbers” is due within 15
months after enactment.
SANITARY TRANSPORTATION OF FOOD
FFDCA § 416, regarding sanitary transportation practices for
No comparable provision.
Sanitary Transportation of Food (§ 111)
food, was established in § 7202 of the Safe, Accountable,
Flexible, Efficient Transportation Equity Act: A Legacy for
Requires the Secretary, within one year of enactment, to
Users (SAFETEA-LU), P.L. 109-59, August, 2005. The law
promulgate regulations described in FFDCA § 416(b), which
requires the Secretary to promulgate applicable regulations,
say, “The Secretary shall by regulation require shippers,
but does not state a deadline for doing so.
carriers by motor vehicle or rail vehicle, receivers, and other
persons engaged in the transportation of food to use sanitary
transportation practices prescribed by the Secretary to
ensure that food is not transported under conditions that
may render the food adulterated.” Requires FDA conduct a
study of the transportation of food for U.S. consumption,
addressing certain issues including an examination of the
“unique needs of rural and frontier areas with regard to
delivery of safe food.”
FOOD ALLERGY AND ANAPHYLAXIS MANAGEMENT
FFDCA § 403(w) requires food products that contain any of
No comparable provision.
Food Allergy and Anaphylaxis Management (§ 112)
the eight most common food allergens (defined in FFDCA §
Requires the Secretary, within one year of enactment and in
201(qq)) to declare their presence on the food label.
consultation with the Secretary of Education, to develop, and
Noncompliant food is deemed misbranded. This requirement
make available to local educational agencies (LEAs), guidelines
was established by the Food Allergen Labeling and Consumer
to develop plans for individuals to manage the risk of food
Protection Act of 2004 (P.L. 108-282). The act focused
allergy and anaphylaxis in schools and early childhood
specifically on food labeling and did not address food allergy
education programs. The voluntary guidelines shall address
and anaphylaxis (a severe, whole-body allergic reaction)
specified elements, as follows: (1) parental obligation to
management in schools or elsewhere. FDA has announced it
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S. 510 (Amendment)
is developing a long-term strategy to assist manufacturers to
provide the school with information regarding a student’s
better inform food allergic consumers about the allergens in
food allergy and risk of anaphylaxis; (2) an individual plan
their products.
created with the parent and tailored to each student with a
documented risk for anaphylaxis; (3) communication
strategies between schools and emergency medical services;
(4) strategies to reduce the risk of exposure to anaphylactic
causative agents in classrooms and common areas for
affected students; (5) training and education for school and
program personnel, parents, and children; (6) authority and
training of program personnel to administer epinephrine
when the nurse is not immediately available, and the
availability of epinephrine for this purpose; (7) as part of an
individual plan, a plan that addresses the response to an
anaphylactic incident in a child engaged in extracurricular
programs; (8) maintenance of information for each
administration of epinephrine to a child, and prompt
notification of parents; and (9) other elements the Secretary
determines to be necessary. An individual management plan
developed pursuant to this section shall be considered an
education record for the purpose of the Family Educational
Rights and Privacy Act of 1974 (FERPA) [20 U.S.C. § 1232g].
Nothing in this section or the guidelines developed by the
Secretary shall be construed to preempt state law, including
any state law regarding whether students at risk for
anaphylaxis may self-administer medication.
Authorizes the Secretary to award non-renewable food
al ergy management incentive grants for up to two years to
assist LEAs with adoption and implementation of the
voluntary food allergy management guidelines. LEAs must
provide matching funds of at least 25% of the amount of the
grant and report to the Secretary with information on how
the grant money was spent and the status of implementation
of the guidelines. In awarding grants under this subsection,
the Secretary 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
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S. 510 (Amendment)
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 al ergy
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
FFDCA section 413 [21 U.S.C. 350b] requires that
No comparable provision.
New Dietary Ingredients (§ 113)
manufacturers and distributors of dietary supplements who
wish to market dietary supplements that contain “new
Amends 21 U.S.C. 350b. Requires the Secretary to notify the
dietary ingredients" (those not marketed in the United States
U.S. Drug Enforcement Agency, as specified, if s/he
in a dietary supplement before October 15, 1994) notify FDA
determines that the information in a new dietary ingredient
about these ingredients.
notification submitted under this section for an article
purported to be a new dietary ingredient is inadequate to
establish that a dietary supplement containing such article will
reasonably be expected to be safe because the article may be,
or may contain, an anabolic steroid or an analogue of an
anabolic steroid. Requires the Secretary to publish guidance
that clarifies when a dietary supplement ingredient is a new
dietary ingredient, among other things.
SEAFOOD (See also “Hazard Analysis and Risk-Based Preventive Controls” section of this report.)
The National Shel fish Sanitation Program (NSSP) is the
No comparable provisions.
Requirements for Guidance Relating to Post Harvest
federal/state cooperative program recognized by FDA and
Processing of Raw Oysters (§ 114)
the Interstate Shel fish Sanitation Conference (ISSC; see next
paragraph) for the sanitary control of shel fish produced and
Creates for the Secretary and GAO certain requirements
sold for human consumption. The purpose of the NSSP is to
(see below) triggered when the FDA issues—related to the
promote and improve the sanitation of shel fish (oysters,
post harvest processing of raw oysters—(1) guidance,
clams, mussels and scal ops) moving in interstate commerce
regulation, or suggested amendment to the NSSP’s Model
through federal/state cooperation and uniformity of state
Ordinance; or (2) guidance or regulation relating to the
shellfish programs. Participants in the NSSP include agencies
Seafood HACCP Program (21 CFR parts 123 and 1240).
from shellfish producing and non-producing States, FDA,
Not later than 90 days prior to issuance, requires the
EPA, NOAA, and the shellfish industry.
Secretary to submit to Congress a report on the projected
The ISSC is a voluntary national organization of state shellfish
public health benefits, cost of compliance, feasibility of
regulatory officials that provide guidance and counsel on
implementation, and certain other topics. This requirement
matters for the sanitary control of shel fish. The ISSC has
does not apply to the guidance described in 103(h) (Updating
Guidance Relating to Fish and Fisheries Products Hazards and
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S. 510 (Amendment)
adopted formal procedures for state representatives to
Controls, discussed below). This requirement is waived if the
review shellfish sanitation issues and develop regulatory
Secretary issues a guidance that is adopted as a consensus
guidelines. Following FDA concurrence, these guidelines are
agreement between federal and state regulators and the
published in revisions of the NSSP Model Ordinance.
oyster industry, acting through the ISSC.
FDA’s Seafood HACCP Program regulations are articulated
Not later than 30 days after the Secretary issues a proposed
in 21 CFR parts 123 (fish and fishery products) and 1240
regulation or guidance described above, requires the GAO to
(control of communicable diseases).
(1) review and evaluate the Secretary’s report and report its
findings to Congress, (2) compare such proposed regulation
FDA’s Fish and Fisheries Products Hazards and Controls
or guidance to similar regulations or guidance for other
Guidance was published by the agency to assist processors of
regulated foods, including a comparison of risk, and (3)
fish and fishery products in the development of HACCP
evaluate the impact of post harvest processing on the
plans, which are required under regulations at 21 CFR 12.
competitiveness of the U.S. oyster industry domestically and
Despite FDA’s stated intention to update the guidance every
in international markets.
2 to 3 years, the most recent edition is dated June 2001.
Requires any report prepared under the section to be made
public.
Updating Guidance Relating to Fish and Fisheries
Products Hazards and Controls (§103, part) Requires
the Secretary to update the Fish and Fisheries Products
Hazards and Control Guidance to take into account advances
in technology since its previous publication.
PORT SHOPPING
FFDCA section 801(n) provides FDA with the authority to
No comparable provision.
Port Shopping (§ 115)
help prevent “port shopping,” whereby importers of refused
goods try to import through another port when refused
Until the Secretary promulgates a final rule that implements
entry at one port. The provision authorizes FDA to require
the amendments made by section 308 of the Bioterrorism
refused food to be marked with the statement “UNITED
Act of 2002, requires the Secretary to notify the Secretary of
STATES: REFUSED ENTRY.” This authority was enacted in
Homeland Security of instances of import refusals under
section 308 of the Bioterrorism Act of 2002 (P.L. 107-188)
FFDCA section 801(a) (Imports; list of registered foreign
establishments; samples from unregistered foreign
establishments; examination and refusal of admission) to alert
U.S. Customs and Border Protection and prevent imports
refused at one port from being admitted by another port.
See 52 row of this table for § 116 of S. 510 regarding alcohol.
FOOD DECONTAMINATION AND DISPOSAL
Depending on the type(s) of contaminant and the type(s) of
No comparable provision.
Decontamination and Disposal Standards and Plans
food involved, several federal agencies and a variety of laws
(§ 208)
may be involved in various steps in the process of
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Background, Applicable Current Law, and
Administration Statements
H.R. 2749 (House-passed)
S. 510 (Amendment)
decontamination, disposal, and/or remediation following an
Requires the Administrator of the Environmental Protection
agriculture or food emergency. In addition to agencies that
Agency (EPA), in coordination with the Secretaries of HHS,
provide scientific and technical assistance—particularly EPA,
DHS, and USDA, to provide support and technical assistance
and various agencies in DHS, HHS, and USDA—the Federal
to state, local, and tribal governments in preparing for,
Emergency Management Agency (FEMA) may be involved if
assessing, decontaminating, and recovering from an
the incident is sufficiently large in scope, and the Federal
agriculture or food emergency. Activities shall include: (1) the
Bureau of Investigation may be involved if it resulted from a
development and dissemination of standards and protocols;
deliberate act. In addition, state authorities may play a leading
(2) jointly developed model plans for the decontamination of
role, and may seek technical and other assistance from
individuals, equipment, and facilities following an intentional
appropriate federal agencies. Several Emergency Support
incident, and the disposal of large quantities of infected or
Function annexes in FEMA’s National Response Framework
contaminated animals, plants, or food products; and (3) the
provide insights into the possible roles and coordination of
conduct of annual exercises, consistent with the mandated
various federal agencies in response to an agriculture or food
DHS national exercise program. Based on findings from
emergency.
exercises, model plans shal be updated at least biennial y.
The development of standards and plans shal be prioritized,
considering: the highest-risk biological, chemical, and
radiological threat agents; agents that could cause the
greatest economic devastation to the agriculture and food
system; and agents that are most difficult to clean or
remediate.

IMPORT CERTIFICATION (See also “Use of Third Parties for Imports and for Laboratory Accreditation” and “Food Imports” sections of this report, and 69 and 81 rows of this table.)
The steady increase in food imports, a result of globalization
Certification and Accreditation (§ 109, part)
Authority to Require Import Certifications for Food
and consumer desire for a wider variety of foods year-round,
(§ 303)
has generated growing concerns about whether current
Amends FFDCA § 801 by authorizing the Secretary to
federal programs sufficiently ensure the safety of these
require, as a condition of granting admission for an imported
Amends FFDCA § 801 by authorizing the Secretary to
imports. Most of the recent debate has included extensive
food article, that a “qualified certifying entity provide a
require certification or other assurance of the safety of an
discussion about how to improve current import safeguards,
certification that the article complies with specified
article of food imported or offered for import, and to deny
within resource constraints, and without unduly restraining
requirements” of the FFDCA. This requirement is to take
entry to any food offered for import that does not meet such
free trade.
effect on or after three years from date of enactment.
a requirement. The Secretary may base such a requirement
However, the Secretary must only require such certification
on public health considerations, including risks associated
Current law does not explicitly authorize, or require, any
in the following situations:
with the food or its place of origin. Such certification shall be
certification of imports, and whether FDA has what is often
used for designated food imported from countries with
cal ed “equivalence authority" has been a matter of debate
• For food imported from a particular country, territory, or
which the FDA has an agreement to establish a certification
(also see below). Regardless, it does not have a program like
region, where the Secretary finds based on scientific risk-
program. Certifying entities—those who may provide
that of FSIS, which many consider to be a form of
based evidence that the government controls there are
certification or assurances—include an agency or a
certification. Under the FMIA and PPIA, no foreign
inadequate and that such certification would assist in
representative of the government of the country from which
establishment can ship its products to the United States until
determining the admissibility of the food;
the article of food at issue originated, as designated by such
FSIS has determined that the establishment’s country has a
• For a food type for which there is scientific evidence that
government or the Secretary; or such other persons or
meat and/or poultry safety program that provides a level of
entities accredited to conduct audits, pursuant to § 808, as
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S. 510 (Amendment)
protection that is at least equivalent to the U.S. system. FSIS
there is a particular risk that presents a threat of serious
established by this act, to provide such certification or
visits the exporting country to review its rules and
adverse health consequences or death and that such
assurance. The Secretary may require periodic renewal, or
regulations, meets with foreign officials, and accompanies
certification would assist in determining whether the article
determine that a current certification is not valid. The
them on visits to establishments. In addition, FSIS operates a
poses such risk; or
Secretary shall provide for electronic submission of required
reinspection program at 150 import houses located near
certifications. Certifying agents who make false statements
approximately 35 border entry points. Some have suggested
• For an article imported from a particular country or
shall be subject to criminal fines or imprisonment pursuant to
that the FDA program should operate more like that of FSIS,
territory, if the Secretary has an agreement with that
18 U.S.C. § 1001. If the Secretary determines that the food
although they acknowledge the difficulties and resource
government providing for such certification.
safety systems of a foreign country or region do not meet
demands of attempting to regulate many more different types The Secretary, in coordination with the Commissioner for
the requirements of this section, the Secretary shall, to the
of foods from many more countries of origin.
Customs and Border Protection, shall provide for the
extent practicable, identify such inadequacies and a means for
the country or region to notify the Secretary of subsequent
Obama Administration: Dr. Hamburg’s testimony
electronic submission of certifications. A certification may
improvements. Amendments made by this section shall not
expresses support for relying not only on foreign
take the form of a statement that the article, or the facility or limit the Secretary’s authority to conduct inspections of
governments for international inspections but also having the farm “that manufactured, processed, packed, held, grew,
imported food or to take such other steps as the Secretary
flexibility to explore use of an accreditation system and audit
harvested, sorted, or transported” it, complies with FFDCA
deems appropriate to determine the admissibility of imported
the performance of accredited third parties.
requirements as specified by the Secretary, or take any other
form specified by the Secretary including a listing of certified
food.
facilities or other 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 Secretary’s authority to conduct random import
inspections, issue import alerts for detaining products, or
take other steps necessary to determine imports’
admissibility. Other § 109 provisions regarding qualified
certifying entities are discussed in a later section, “Third-
Party Accreditation.”
PRIOR NOTICE OF IMPORTS
FFDCA § 801(m) requires the Secretary to establish, by
No comparable provision.
Prior Notice of Imported Food Shipments (§ 304)
regulation, procedures and requirements by which an
importer shall give FDA prior notice of shipments of food
Amends the list of elements that must be provided in the
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S. 510 (Amendment)
intended for importation, in order that FDA can make
notice required under FFDCA § 801(m) by adding the
determinations regarding the admissibility of the food. The
identity of “any country to which the article has been refused
FFDCA stipulates certain required data elements that must
entry.” Within 120 days of enactment, the Secretary shal
be included in the notice, including the country from which
publish an interim final rule implementing this amendment,
the food originated, and the country from which the food is
which shal take effect 180 days after the date of enactment.
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
Current law would not prohibit the development of the plan
No comparable provision.
Building Capacity of Foreign Governments with
proposed by this section of S. 510 (right). Implementation of
Respect to Food (§ 305)
certain elements of such a plan may be authorized under: (1)
FFDCA § 803, which authorizes an HHS Office of
Requires the Secretary, within two years of enactment, to
International Relations to, among other things, reach
develop a comprehensive plan to expand the technical,
agreements with other governments regarding practices and
scientific, and regulatory capacity of foreign governments, and
standards; and (2) PHS Act § 307, authorizing collaborations
their respective food industries, from which foods are
with foreign governments for the purposes of research and
exported to the United States. In developing the plan, the
education regarding health-related matters.
Secretary shal consult with the Secretaries of Agriculture,
State, Treasury, Homeland Security, and Commerce, the U.S.
Trade Representative, representatives of the food industry,
appropriate foreign government officials, and non-
governmental organizations that represent the interests of
consumers, and other stakeholders. The plan shal include, as
appropriate: (1) recommendations for bilateral and
multilateral arrangements and agreements, including
provisions for responsibility of exporting countries to ensure
the food safety; (2) provisions for electronic data sharing; (3)
provisions for mutual recognition of inspection reports; (4)
training of foreign governments and food producers on U.S.
food safety requirements; (5) recommendations to
harmonize requirements under Codex Alimentarius; and (6)
provisions for multilateral acceptance of laboratory methods
and detection techniques. This section does not apply to
dietary supplements.
SMUGGLED FOOD
The FFDCA does not appear to address or to define the
No comparable provision.
Smuggled Food (§ 309)
term “smuggled food,” although Chapter VIII of the act
covers imports and exports.
Requires the Secretary, within 180 days of enactment, in
consultation with designated officials in the Department of
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Background, Applicable Current Law, and
Administration Statements
H.R. 2749 (House-passed)
S. 510 (Amendment)

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.”
Source: Table created by CRS staff based on the text of the House-passed H.R. 2749 and the S. 510 Amendment.
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Author Contact Information

Renée Johnson
Erin D. Williams
Specialist in Agricultural Policy
Specialist in Public Health and Bioethics
rjohnson@crs.loc.gov, 7-9588
ewilliams@crs.loc.gov, 7-4897
Sarah A. Lister
Vanessa K. Burrows
Specialist in Public Health and Epidemiology
Legislative Attorney
slister@crs.loc.gov, 7-7320
vburrows@crs.loc.gov, 7-0831

Acknowledgments
This report was originally written by Geoffrey S. Becker, Specialist in Agricultural Policy.

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