The FDA Food Safety Modernization Act (P.L. 111-353)
Congressional research reportFeb 18, 2011
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The FDA Food Safety Modernization Act
(P.L. 111-353)
(name redacted), Coordinator
Specialist in Agricultural Policy
February 18, 2011
Congressional Research Service
7-....
www.crs.gov
R40443
The FDA Food Safety Modernization Act (P.L. 111-353)
Summary
The 111th Congress passed comprehensive food safety legislation in December 2010 (the FDA
Food Safety Modernization Act, or FSMA, P.L. 111-353). Although numerous agencies share
responsibility for regulating food safety, this newly enacted legislation focused on foods regulated
by the Food and Drug Administration (FDA) and amended FDA’s existing structure and
authorities, in particular via the Federal Food, Drug, and Cosmetic Act (FFDCA; 21 U.S.C. §§
301 et seq.). The new law does not directly affect activities at the U.S. Department of Agriculture
(USDA), which oversees the safety of most meat and poultry.
FSMA generally expands or modifies existing FDA authorities rather than creating a new food
safety structure or authorities. Among its many provisions, the new law will increase frequency of
inspections at food facilities, tighten record-keeping requirements, extend more oversight to
certain farms, and mandate product recalls if a firm fails to institute them voluntarily. The new
law will require food processing, manufacturing, shipping, and other regulated facilities to
conduct an analysis of the most likely safety hazards and to design and implement risk-based
controls to prevent them. FSMA also will facilitate the establishment of science-based
“performance standards” for the most significant food contaminants. Other provisions in the new
law are also intended to improve the nation’s foodborne illness surveillance systems. FSMA also
mandates increased scrutiny of food imports, which account for a growing share of U.S.
consumption; food import shipments will 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. FSMA
also contains provisions for certifying or accrediting laboratories, including private laboratories,
to conduct sampling and testing of food, among other provisions. This report provides a detailed
overview of these and other major provisions in the newly enacted law.
The 112th Congress will likely provide oversight and scrutiny of how the law is implemented,
including FDA’s coordination with other federal agencies. Implementation of the law will depend
largely on the availability of discretionary appropriations, and some have questioned whether
funding should be provided in the current budgetary climate. In addition, the 112th Congress may
consider changes to other food safety laws and policies that continue to be actively debated in
Congress. Continued congressional interest in reforming the nation’s food safety laws and in
monitoring food safety issues is expected, given other perceived problems with the current food
safety system.
Congressional Research Service
The FDA Food Safety Modernization Act (P.L. 111-353)
Contents
Introduction...................................................................................................................................... 1
Food Safety Incidents ................................................................................................................ 2
Food Safety Legal and Regulatory Landscape .......................................................................... 3
Administration Views ................................................................................................................ 5
Congressional Action................................................................................................................. 6
Selected Issues ................................................................................................................................. 9
Facility Registration ................................................................................................................ 10
Record-Keeping and Documentation Requirements ............................................................... 10
Hazard Analysis and Risk-Based Preventive Controls ............................................................ 11
Performance Standards ............................................................................................................ 12
On-Farm Safety Standards; Safety of Produce ........................................................................ 13
Mitigating Effects on Small Business and Farming Operations .............................................. 15
Targeting of Inspections .......................................................................................................... 16
Use of Third Parties for Imports and for Laboratory Accreditation ........................................ 19
Mandatory Recall Authority .................................................................................................... 20
Notification of Contaminated Products and Product Tracing .................................................. 21
Foodborne Illness Surveillance and Outbreak Response......................................................... 22
Criminal Penalties ................................................................................................................... 23
Dietary Supplements ............................................................................................................... 25
Food Imports ........................................................................................................................... 26
Paying for Food Safety with User Fees ................................................................................... 28
Tables
Table 1. FDA Food-Related Inspection Data, FY2004-FY2010 ................................................... 17
Table 2. Criminal Penalties for Violations of FFDCA § 303(a)..................................................... 24
Table 3. FDA Direct Appropriations for Foods, FY2005-FY2010 ................................................ 28
Table 4. Fees in the FDA Food Safety Modernization Act (FSMA, P.L. 111-353) ....................... 30
Table 5. Select Details of Fees Authorized in the FDA Food Safety Modernization Act
(FSMA, P.L. 111-353) ................................................................................................................ 31
Appendixes
Appendix A. FDA Food Safety Modernization Act (P.L. 111-353) Provisions ............................. 32
Appendix B. Comparison of Provisions in the FDA Food Safety Modernization Act
(FSMA, P.L. 111-353), with Previously Existing Law ............................................................... 34
Contacts
Author Contact Information........................................................................................................... 58
Acknowledgments ......................................................................................................................... 58
Congressional Research Service
The FDA Food Safety Modernization Act (P.L. 111-353)
Introduction
The combined efforts of the food industry and government regulatory agencies often are credited
with making the U.S. food supply among the safest in the world. Nonetheless, public health
officials have estimated that each year in the United States, many millions of people become sick
and thousands die from foodborne illnesses caused by any of a number of microbial pathogens
and other contaminants.1 At issue is whether the current food safety system has the resources,
authority, and structural organization to safeguard the health of American consumers, who spend
more than $1 trillion on food each year.2 Also at issue is whether federal food safety laws, first
enacted in the early 1900s, have kept pace with the significant changes that have occurred in the
food production, processing, and marketing sectors since then.
In 2007 and again in 2009, the Government Accountability Office (GAO) placed food safety on
its biennially published list of high-risk areas, one of 30 needing concerted attention by Congress
and the Administration.3 GAO has identified 15 federal agencies collectively administering at
least 30 laws related to food safety. The majority of both total funding and total staffing, however,
is with the Food Safety and Inspection Service (FSIS) at the U.S. Department of Agriculture
(USDA), which regulates most meat and poultry, and the Food and Drug Administration (FDA) at
the U.S. Department of Health and Human Services (HHS), which regulates virtually all other
foods. FSIS’s annual budget in FY2010 was approximately $1.1 billion in appropriated funds,
plus an estimated $131 million in industry-paid user fees. FDA’s annual budget in FY2010 for its
human foods program was $784 million, all of it appropriated.4
After discussing several recent food safety incidents and the systemic food safety problems that
they illustrate, this report 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. It then provides a detailed overview of the major provisions in the
newly enacted law—the FDA Food Safety Modernization Act (FSMA, P.L. 111-353). The report
is organized around a number of selected food safety issues, describing how they are addressed in
previously existing law and regulations, and describing their treatment in the newly enacted law.
Finally, appendixes provide a crosswalk of all provisions in FSMA, followed by a side-by-side
comparison of each of these provisions with previously existing law.
1
The Centers for Disease Control and Prevention (CDC) estimates that each year roughly 1 out of 6 Americans (or 48
million people) get sick, 128,000 are hospitalized, and 3,000 die from foodborne diseases. CDC, “Estimates of
Foodborne Illness in the United States,” http://www.cdc.gov/foodborneburden/index.html.
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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The FDA Food Safety Modernization Act (P.L. 111-353)
Food Safety Incidents
Food safety-related incidents frequently heighten public and media scrutiny of the U.S. food
safety system.5 Large recalls of FSIS-regulated meat and poultry products due to findings of E.
coli O157:H7, Listeria, and other problems occur each year.6 In addition, in recent years, several
large multi-state 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 an 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.7 In August, FDA found
the same pathogen on two egg farms in Iowa, leading to the nationwide recall by the companies
of more than 500 million eggs.8 In July 2009, FDA had published a long-awaited egg safety
regulation, which became effective in July 2010 as the outbreak was well underway.9 Although
most observers believe that the rule, if enforced, will help to prevent shell egg contamination and
outbreaks in the future, many remain concerned about the apparent lack of coordination between
USDA’s egg quality inspection activities and FDA’s food safety activities, because both agencies
have regulatory responsibility for egg products.10
5
See CRS Report R40916, Food Safety: Foodborne Illness and Selected Recalls of FDA-Regulated Foods. For other
information on “Recalls, Market Withdrawals, & Safety Alerts,” see FDA’s website: http://www.fda.gov/Safety/
Recalls/default.htm.
6
See CRS Report RL34313, The USDA’s Authority to Recall Meat and Poultry Products. For other information on
meat and poultry recalls, see FSIS’s website: http://www.fsis.usda.gov/fsis_recalls/index.asp.
7
USDA regulates processed egg products, and grades shell eggs for quality (such as grade and size), but does not
oversee the safety of shell eggs.
8
FDA, “Salmonella Enteritidis Outbreak in Shell Eggs,” http://www.fda.gov/Food/NewsEvents/.
9
FDA, “Prevention of Salmonella Enteritidis in Shell Eggs During Production, Storage, and Transportation; Final
Rule,” 74 Federal Register 33029, July 9, 2009. See also FDA, “Egg Safety Final Rule,” http://www.fda.gov/Food/
FoodSafety/Product-SpecificInformation/EggSafety/EggSafetyActionPlan/ucm170615.htm.
10
Alicia Mundy, Bill Tomson, “Egg Inspectors Failed to Raise Alarms,” The Wall Street Journal, September 10, 2010.
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The FDA Food Safety Modernization Act (P.L. 111-353)
Food Safety Legal and Regulatory Landscape
Federal responsibility for food safety rests primarily with FDA and USDA.11 FDA is responsible
for ensuring that most 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
meatpacking 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.12
In the 111th Congress, major food safety legislation—the subject of this report—was passed,
focusing 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 of FFDCA are “adulteration” and “misbranding.” FDAregulated 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 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.
11
For further background information about the food safety system, see CRS Report RS22600, The Federal Food
Safety System: A Primer. For further information about FDA’s regulatory authority, see CRS Report RS22946, Food
and Drug Administration (FDA): Overview and Issues.
12
For a discussion of the history of federal food safety organization and of efforts to change it, see Richard A. Merrill
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 equally 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 FFDCA, introducing adulterated food into commerce, adulterating food that is in commerce, or the
receipt and delivery of adulterated food in commerce, is prohibited (FFDCA § 402(a) [21 U.S.C. § 342(a)]).
A food shall be deemed to be adulterated—(1) If it bears or contains any poisonous or deleterious substance which may render it injurious
to health; but in case the substance is not an added substance such food shall not be considered adulterated under this clause if the quantity
of such substance in such food does not ordinarily render it injurious to health; [or](2)(A) if it bears or contains any added poisonous or
added deleterious substance (other than a substance that is a pesticide chemical residue in or on a raw agricultural commodity or processed
food, a food additive, a color additive, or a new animal drug) that is unsafe within the meaning of § 406; or (B) if it bears or contains a
pesticide chemical residue that is unsafe within the meaning of § 408(a); or (C) if it is or if it bears or contains (i) any food additive that is
unsafe within the meaning of § 409; or (ii) 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 FFDCA, introducing misbranded food into commerce, misbranding food that is in commerce, or the
receipt and delivery of misbranded food in commerce is prohibited. (See “Prohibited Acts,” below.) FFDCA § 403 [21 U.S.C. §
343] defines a number of conditions under which a food would be deemed to be misbranded, beginning with a broad provision in
paragraph (a) saying that a food is deemed misbranded if its label “is false or misleading in any particular ...” Similar to the definition
of adulteration, numerous specific types of misbranding are also defined. These include, among others, failure to disclose specific
additives or allergens in the food, and failure to provide required nutritional information.
Person: FFDCA § 201(e) [21 U.S.C. § 321(e)] defines person to include an individual, partnership, corporation, and association. In
this report, for simplicity, facility is often used to refer to actions that may or must be taken with respect to a facility, though it is,
of course, a person, typically the owner, operator or agent in charge of the facility, who may or must act.
Facility: FFDCA § 415(b) [21 U.S.C. § 350d(b)] defines a food facility as “any factory, warehouse, or establishment (including a factory,
warehouse, or establishment of an importer) that manufactures, processes, packs, or holds food. Such term does not include farms;
restaurants; other retail food establishments; nonprofit food establishments in which food is prepared for or served directly to the consumer;
or fishing vessels (except such vessels engaged in processing as defined in [21 C.F.R. 123.3(k)]).”
Retail Food Establishment: Defined in 21 C.F.R. 1.227(b)(11) as “an establishment that sells food products directly to consumers
as its primary function.” Such establishments may include restaurants, grocery stores, convenience stores, vending machine
locations, and establishments that manufacture/process, pack, or hold food as their primary function (if the annual monetary value
of sales of food products directly to consumers exceeds the annual monetary value of sales of food products to all other buyers).
Prohibited Acts: Prohibited acts are listed in FFDCA § 301 [21 U.S.C. § 331]. Along with other specified prohibited acts in
FFDCA § 301, paragraphs (a) through (c) provide that introducing adulterated or misbranded food into commerce; adulterating
or misbranding food that is in commerce; or the receipt and delivery of adulterated or misbranded food in commerce is
prohibited. Pursuant to FFDCA § 303 [21 U.S.C. § 333], in general, any person who violates a provision of FFDCA § 301 may be
subject to civil or criminal penalties, including imprisonment, fines, or both. Criminal penalties provided for in 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 FFDCA. A version of 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 (miscellaneous 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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The FDA Food Safety Modernization Act (P.L. 111-353)
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.13 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.”14 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.”15 In July 2009,
the FSWG announced a number of steps the Obama Administration was taking, under existing
authorities, to improve government safeguards.16 The group released a one-year progress report in
July 2010.17 Also, the Administration announced that it had “taken steps to reduce the prevalence
of E. coli, implemented new standards to reduce exposure to Campylobacter, and issued a rule to
control Salmonella contamination,” and that “FDA has conducted a pilot study on a tracing
system, and HHS, in collaboration with USDA, has rolled out an enhanced and updated
www.foodsafety.gov site to provide consumers rapid access to information on food recalls.”18
The Obama Administration weighed in on the principal bills that were considered by the House
and Senate during the 111th Congress (and that are the subject of this report). The Administration
declared its support for the primary food safety bill in the House of Representatives, H.R. 2749,
which had been passed in June 2009.19 Also, in a July 2010 statement, the Administration urged
the Senate to complete its work on its principal food safety bill, S. 510.20 In November 2010, the
Administration expressed its continued support of the Senate’s efforts on its bill.21 In addition,
13
FDA, Food Protection Plan: 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.
14
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.
15
The working group established a public website at http://foodsafetyworkinggroup.gov/, where the full text of these
remarks may be viewed.
16
FSWG, “Food Safety Working Group: Key Findings,” July 7, 2009, http://www.foodsafetyworkinggroup.gov/.
17
FSWG, “Food Safety Working Group: Progress at 1 Year,” July 9, 2010, http://www.foodsafetyworkinggroup.gov/.
18
The White House, Statement by the President on Food Safety, July 7, 2010, http://www.whitehouse.gov/the-pressoffice/statement-president-food-safety.
19
The White House, Statement by the President on House Passage of the Food Safety Enhancement Act of 2009, July
30, 2009, http://www.whitehouse.gov/the-press-office/statement-president-house-passage-food-safety-enhancementact-2009.
20
The White House, Statement by the President on Food Safety, July 7, 2010, http://www.whitehouse.gov/the-pressoffice/statement-president-food-safety.
21
The White House, Statement of Administration Policy, “S. 510—The FDA Food Safety Modernization Act,”
November 16, 2010, http://www.whitehouse.gov/sites/default/files/omb/legislative/sap/111/saps510s_20101116.pdf.
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The FDA Food Safety Modernization Act (P.L. 111-353)
Administration officials testified on aspects of the legislation. Testimony regarding specific
provisions of the House bill was given by FDA Commissioner Dr. Margaret Hamburg to the
House Energy and Commerce Subcommittee on Health on June 3, 2009, and by FDA Senior
Advisor Michael R. Taylor to the House Agriculture Committee on July 16, 2009.22
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 addressed a key policy concern by
refocusing FDA’s food safety system on prevention, the Commissioner stated. She added that the
bill also generally met 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 the use of
accredited third parties to ensure adequate resources.23 These issues are among those discussed
later in this report.
Congressional Action
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.
Committee Jurisdiction for Key Food Safety Issues
House Authorizing Committees
The House Committee on Energy and Commerce has jurisdiction over all FDA-regulated products, including foods.
The House Committee on Agriculture claims the lead on USDA’s meat and poultry inspection programs.
Senate Authorizing Committees
The Senate Committee on Health, Education, Labor, and Pensions (HELP) has jurisdiction over FDA-regulated foods
and other products. The Senate Committee on Agriculture, Nutrition and Forestry has jurisdiction over USDA
inspection programs.
Congressional Appropriations Committees
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; the House Committee on Energy
and Commerce; the Senate Committee on Health, Education, Labor, and Pensions (HELP); the House Committee on
Small Business; the House Committee on Oversight and Government Reform; the House Committee on Homeland
Security; the House Committee on Ways and Means; the Senate Appropriations Committee; and the 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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The FDA Food Safety Modernization Act (P.L. 111-353)
In the 111th Congress, nearly a dozen food safety bills, several of them comprehensive, were
introduced. The major vehicle in the House was 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, S. 510 was introduced by Senator Richard Durbin. The Senate Committee on
Health, Education, Labor, and Pensions (HELP) amended and reported the bill (without a written
report) on December 18, 2009. During 2010, a series of substitute amendments to the bill were
offered and debated. On November 30, 2010, a substitute version of the bill (S.Amdt. 4715)
passed the Senate with a recorded vote of 73-25.27 However, a procedural issue held up final
action on the legislation; it was resolved when the Senate inserted its version of the bill into an
earlier House bill (H.R. 2751) that was cleared by the House. This bill was signed by the
President in January 2011 as the FDA Food Safety Modernization Act (FSMA, P.L. 111-353).
FSMA generally expands or modifies existing FDA authorities under the Federal Food, Drug, and
Cosmetic Act (FFDCA; 21 U.S.C. §§ 301 et seq.). Among its many provisions, the new law
increases frequency of inspections at food facilities, tightens record-keeping requirements,
extends more oversight to certain farms, and mandates product recalls if a firm fails to institute
them voluntarily.
FDA has identified five key elements to the new law.28
•
Preventive Controls. For the first time, FDA has a legislative mandate to require
comprehensive, prevention-based controls across the food supply. FSMA requires
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. This provision is similar
conceptually to the so-called hazard analysis and critical control point, or
HACCP, plans required of meat and poultry establishments. The new law
requires the establishment of science-based “performance standards” for the most
significant food contaminants. To aid in determining such risks and hazards, the
new law seeks to improve foodborne illness surveillance systems, aiming for
better data reporting, analysis, and usefulness, with the CDC playing a lead role.
Provisions in FSMA extend safeguards to the farm level, generally calling for
new, science-based “performance standards” for safe production mainly of fruits,
vegetables, and related products, and expanding enforcement and record-keeping
authorities. The new law facilitates the establishment of science-based
regulations for the most significant food contaminants.
26
Two other comprehensive House bills were introduced by Representative Rosa DeLauro (H.R. 875) and by
Representative Jim Costa (H.R. 1332).
27
Senator Tom Harkin, “Proposed Amendment, S. 510,” Congressional Record, November 18, 2010, pp. S8069S8093.
28
FDA, “Questions and Answers on the Food Safety Modernization Act,” http://www.fda.gov/NewsEvents/
PublicHealthFocus/ucm238506.htm. Other supplemental information is from CRS.
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•
Inspection and Compliance. FSMA reflects the fact that inspection is an
important means of holding industry accountable for its responsibility to produce
safe food. FSMA seeks to increase the frequency of plant inspections, specifying
how often FDA should inspect food producers, while taking into account the
risks posed by specific foods or processes. To aid in such inspections, and to
improve the ability to rapidly trace food products through the production and
marketing chain in the event of a foodborne illness outbreak, suspected
contamination, or other problems, the new law generally seeks to strengthen
record-keeping requirements and food traceability systems. Food processing,
manufacturing, shipping, and other regulated facilities are required to conduct an
analysis of the most likely safety hazards and to design and implement risk-based
controls to prevent them. FDA has said that it is “committed to applying its
inspection resources in a risk-based manner and adopting innovative inspection
approaches.”29
Industry participants will 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 (Bioterrorism
Act, P.L. 107-188; 21 U.S.C. § 350d), will need to re-register more frequently
than they have previously. The new law also requires that additional registration
information be submitted.
29
30
•
Imported Food Safety. FSMA increases scrutiny of food imports, which account
for a growing share of U.S. consumption; food import shipments must be
accompanied by documentation that they can meet safety standards that are at
least equivalent to U.S. standards. Such certifications may be provided by foreign
governments or other so-called third parties accredited in advance. FSMA also
contains provisions for certifying or accrediting laboratories, including private
laboratories, to conduct sampling and testing of food, among other provisions.
For example, for the first time, importers must verify that their foreign suppliers
have adequate preventive controls in place to ensure safety, and FDA will be able
to accredit qualified third party auditors to certify that foreign food facilities are
complying with U.S. food safety standards.
•
Response. For the first time, FDA has mandatory recall authority for all food
products, if a firm with suspect products fails to recall them voluntarily. FDA had
lacked such authority for food, except for infant formula. FDA has said that it
expects that “it will only need to invoke this authority infrequently since the food
industry largely honors our requests for voluntary recalls.”30
•
Enhanced Partnerships. FSMA directs FDA to improve training of state, local,
territorial, and tribal food safety officials. The law strengthens existing
collaboration among all food safety agencies—federal, state, local, territorial,
tribal, and foreign—to achieve its public health goals.
Ibid.
Ibid.
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Certain food processing operations are exempt from the proposed HACCP requirements, and
some farms are also exempt from the new produce standards. Specifically, farms and food
facilities that qualify for an exemption are those businesses with an “average annual monetary
value” of less than $500,000 for all food sold during the previous three-year period, provided that
the food is sold directly to “qualified end users” such as consumers, restaurants, or retail food
establishments located in the same state where the facility sold the food or within 275 miles of the
facility, among other requirements. In addition, among the types of businesses that are considered
to be “retail food establishments” and therefore generally not subject to the facility registration
requirements, FSMA also exempts roadside stands, farmers’ markets, and foods sold through a
community-supported agriculture (CSA) program.
FSMA is explicit in maintaining the separate jurisdictions between FDA and USDA.31
The Congressional Budget Office (CBO) has estimated that implementing the new law will
increase net federal spending subject to appropriation by about $1.4 billion over a five-year
period (FY2011-FY2015).32 Although the law authorized appropriations when it established the
new food safety system, it did not provide the actual funding needed for FDA to perform these
activities. The law provides for limited amounts of fees and other offsets; its implementation will
depend largely on discretionary appropriations. Some have already questioned whether an
expanded investment in this area is appropriate in the current budgetary climate.33 FDA’s deputy
commissioner for foods, Michael Taylor, has indicated that FDA has “already done a lot of work
in anticipation of the new law,” but that funding will continue to be an issue and that building a
new preventive system will require new resources and investment.34
For a comprehensive listing of all sections and topics addressed in the new law, 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 new law. The second table, Appendix B, contains a side-by-side
comparison of FSMA’s provisions with previous law.
Selected Issues
The following sections provide a discussion of the key provisions in the FDA Food Safety
Modernization Act (FSMA, P.L. 111-353). Unless otherwise noted, references to “the Secretary”
mean the HHS Secretary.
31
See FSMA § 403. Past debates have examined proposals to combine all federal food safety agencies and authorities
under a single, possibly Cabinet-level, agency. For example, a bill introduced by Representative DeLauro (H.R. 875)
proposed to transfer FDA’s food safety activities to a new food safety agency within HHS, creating a Food Safety
Administration with an Administrator appointed to a five-year term by the President and confirmed by the Senate.
32
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. Reflecting the August 2010 Senate amendment to S. 510.
33
See Helena Bottemiller, “Food Safety Bill Advocates Expect Funding Fight,” Food Safety News, January 4, 2011.
34
Helena Bottemiller, “FDA’s Taylor: ‘We'll Hit the Ground Running’,” Food Safety News, January 28, 2011.
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Facility Registration
Prior to passage of FSMA, the FFDCA required domestic and foreign food facilities to register
with FDA.35 Excepted were farms, restaurants, retailers, and certain types of nonprofit food
establishments and fishing vessels. Renewal was not required on any periodic basis, but
registrants were required to notify the HHS Secretary in a timely manner of relevant changes in
their status. The FFDCA (§ 801(l); 21 U.S.C. § 381(l)) provided that imported food may not be
delivered to the importer, owner, or consignee of the article unless the foreign facility is
registered.
FSMA Provisions. FSMA (§ 102) amends FFDCA § 415 to 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. It provides for
new 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.” FSMA also provides for procedures for vacating such a suspension. Importing or
introducing such food into commerce is prohibited, and subject to possible civil and criminal
penalties and other enforcement actions. FSMA does not change existing exemptions from the
registration requirement for farms, restaurants, retailers, and certain types of nonprofit food
establishments and fishing vessels. It also does not impose new registration fees for food
facilities.
FSMA clarifies the types of facilities included as a “retail food establishment”36 and therefore
generally not subject to the registration requirements. It requires the HHS Secretary to amend the
definition of “retail food establishment” to include food sold directly to consumers by a roadside
stand or farmers’ market, food sold through a community-supported agriculture (CSA) program,
or sale and distribution of food at any other such direct sales platform as determined by the
Secretary (§ 102(c)).
Record-Keeping and Documentation Requirements
Prior to passage of FSMA, the FFDCA authorized 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.”37 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.38
35
Pursuant to P.L. 107-188, the Bioterrorism Act (FFDCA § 415; 21 U.S.C. § 350d).
21 C.F.R. 1.227(b)(11).
37
Pursuant to P.L. 107-188, the Bioterrorism Act (FFDCA § 414; 21 U.S.C. § 350c).
38
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.
36
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Prior to passage of FSMA, advocates of food safety reform argued that record-keeping
requirements needed to be strengthened to help regulators determine whether firms are complying
with the law, and to facilitate outbreak investigations and product recalls. Among their concerns
has been that records do not have to be maintained in electronic format, which, these advocates
assert, delays outbreak response. Related concerns have included 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. 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.
FSMA Provisions. FSMA (§ 101) amends FFDCA § 414 to expand the Secretary’s authority to
inspect and copy relevant records of a food facility in two ways. It requires 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 has greater flexibility under the
second provision, no longer needing a reasonable belief that food is adulterated in order to access
records. The Secretary may allow access to records regarding foods likely to be affected in a
similar manner, but will need to believe there is at least a risk of harm. Farms and restaurants (as
under previous law) remain fully exempt from this provision. For other facilities, written
notification is still required to gain access.
(See the subsequent section on “Notification of Contaminated Products and Product Tracing” for
additional provisions relating to record-keeping and documentation.)
Hazard Analysis and Risk-Based Preventive Controls
Prior to passage of FSMA, a broad consensus of policymakers agreed that FDA’s system of food
safety safeguards should be more proactive in addressing the nation’s complex food supply.39 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 had been expected to abide by the rules; generally it was only when a problem was
detected—often after an illness outbreak was reported or testing found a contaminant in a
product—that officials would step in to correct it, or order the industry to do so.
A recurring theme in these discussions was the need for prevention. Virtually all stakeholders,
including regulators, the regulated industries, consumer advocates, and food safety scientists
agreed 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.40 A popular version of this approach is the so-called Hazard Analysis and Critical
39
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.
40
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
(continued...)
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Control Points (HACCP) system, which was incorporated in the 1990s by FSIS as a regulatory
requirement for all meat and poultry slaughtering and processing establishments.41 Variations of
the HACCP system also had been required by FDA in the processing of seafood, juices, and lowacid canned foods, but not other product categories.
In a number of reports, the committees of the National Academy of Sciences’ National Research
Council (NAS-NRC) recommended the HACCP approach for food safety.42 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 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.43
FSMA Provisions. FSMA (§ 103) creates new FFDCA requirements for each owner, operator, or
agent of a food facility to evaluate the hazards that could affect food manufactured, processed,
packed, transported, or held there; to identify and implement preventive controls to significantly
minimize, prevent, or eliminate such hazards; and to monitor and maintain records on these
controls once they are in place. It further specifies the types of hazards that should be evaluated,
and requires 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. FSMA
requires written HACCP-type and/or broader written food safety plans containing certain
requirements as part of its so-called Hazard Analysis and Risk-Based Preventive Controls.
FSMA also contains requirements regarding available FDA guidance documents for seafood (see
§ 114 and § 103; also see section of this report titled “Targeting of Inspections”). Some facilities
are exempt from the requirements under certain conditions, as discussed in more detail in the
section below titled “Mitigating Effects on Small Business and Farming Operations.”
Performance Standards
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
(...continued)
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.
41
Robert A. Savage 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.
42
Committee on the Review of the Use of Scientific Criteria and Performance Standards for Safe Food, Scientific
Criteria to Ensure Safe Food, NAS-NRC, 2003. The report notes: “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.... [T]he emphasis of food safety regulatory agencies must continue to be on prevention, reduction, or
elimination of foodborne hazards along the food continuum.” A more recent report in this series is from the Committee
on the Review of the Food and Drug Administration’s Role in Ensuring Safe Food, Enhancing Food Safety: The Role
of the Food and Drug Administration, NAS-NRC, 2010.
43
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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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.”44 The
committee added that regulators like FDA, USDA, and the Environmental Protection Agency
(EPA) have employed specific standards for diverse reasons and conditions, based on numerous
scientific, legal and practical constraints.45 FFDCA authorizes FDA to promulgate standards for
certain hazards, such as tolerances (or legal limits) for pesticide or drug residues in foods, but had
not granted explicit authority to develop standards solely as a means to verify that processing is
done in a manner that ensures safe food.46
FSMA Provisions. FSMA (§ 104) amends FFDCA to require the HHS Secretary to, at least every
two years, review and evaluate epidemiological data, health data, or other information to identify
the most significant hazards and to issue guidance or regulations on science-based performance
standards to significantly minimize, prevent, or eliminate such hazards. Such standards must be
specific to products or product classes, not individual facilities. It places conditions on the
issuance of standards, requiring them to be “[b]ased on such review and evaluation, and when
appropriate to reduce the risk of serious illness or death to humans or animals or to prevent the
adulteration of food” under FFDCA. It further requires that this review and evaluation of “health
data and other relevant information” be conducted in coordination with USDA.
On-Farm Safety Standards; Safety of Produce
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 government and states 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
44
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.
45
Ibid, p. 17. Includes: “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
In 1996, USDA’s Food Safety and Inspection Service (FSIS) 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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harvesting, storing, or distributing raw agricultural commodities generally are excluded.47 Farms
are among those exempted from a requirement that food facilities be registered with FDA,
pursuant to the Bioterrorism Act.48 Further, 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 presents a serious health threat.49
Historically, FDA’s general approach has been not to impose mandatory on-farm safety standards
or inspections of agricultural facilities.50 Rather, the agency has tended 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.51 For example, in July 2009, the Obama
Administration released new draft guidances on three specific types of produce: tomatoes,
melons, and leafy greens.52 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.53
FSMA Provisions. FSMA (§ 105) creates new FFDCA requirements for farms as well as food
processors. The provision that could have the most direct effect on on-farm activity—particularly
growers of fresh produce—is the establishment of new standards for produce safety. The law
requires 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
47
21 C.F.R. 110.19(b). 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.”
48
P.L. 107-188; 21 U.S.C. 350(d).
49
21 U.S.C. 350c and 21 U.S.C. § 374. Dr. Andrew C. von Eschenbach, former 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.
50
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.
51
Most FDA guidance documents include the following statement: “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.
52
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/GuidanceComplianceRegulatoryInformation/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.
53
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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Secretary has determined that such standards minimize the risk of serious adverse health
consequences or death. Coordination with USDA is encouraged, along with coordination with
state agricultural agencies when enforcing standards, as appropriate. Enforcement could be in the
form of audit-based verification systems or other inspection methods. FSMA also includes
language to enable a state or foreign government to request a variance from HHS if needed to
account for local growing conditions. It requires 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.
FSMA exempts some farms from the requirements under certain conditions, as discussed in the
next section, “Mitigating Effects on Small Business and Farming Operations”.
Mitigating Effects on Small Business and Farming Operations
Concerns among farm and rural groups about the potential effects of new food safety
requirements on farms and food processors surfaced early in the food safety legislative debate.
Most vocal were small farms and processors; organizations representing small, organic, direct-tomarket, and sustainable farming operations; and small livestock operations. At issue was 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. For more detailed information, CRS Report RL34612,
Food Safety on the Farm.
Among the options considered during the debate were 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. 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.
FSMA Provisions. As discussed, some provisions in FSMA will directly affect farms and food
processors (§§ 105 and 103, respectively). Other provisions that could potentially affect farms
and food processors include facility registration requirements (§ 102); records access and/or
inspection requirements (§§ 101 and 204); food traceability requirements (§ 204); and targeting
of inspection resources (§ 201). FSMA, however, provides extensive consideration of the needs
of small businesses and provides for coordination of enforcement and education activities with
others such as USDA and state authorities.
FSMA explicitly exempts certain food processors from the newly enacted HACCP-type
requirements and also exempts certain farms from the new produce standards. Food facilities
would qualify for an exemption from the HACCP requirements under § 103 if they are either a
“very small business” as defined by FDA in rulemaking, or if the facility’s “average annual
monetary value” of all food sold during the previous three year period was less than $500,000,
provided that the food is sold directly to “qualified end users” such as consumers, restaurants, or
retail food establishments located in the same state where the facility sold the food or within 275
miles of the facility. Such a facility must demonstrate that it either has “identified potential
hazards associated with the food being produced,” and is implementing and monitoring these
preventive controls, or that it is “in compliance with State, local, county, or other applicable non-
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Federal food safety law.” Foods produced from such a facility will also need to provide the
facility’s name and address on a food packaging label or at the point of purchase.
Farms that are exempt from the produce standards under § 105 also include those with a threeyear average monetary value of the food they sold of less than $500,000, provided that the food is
sold directly to the similarly defined “qualified end users” and if the farm provides similar
notification to consumers. The exemption for both facilities and farms may be revoked in the
event that a foodborne illness outbreak is directly linked to an exempted facility or farm, or based
on a determination by the HHS Secretary.
In addition, as discussed in the “Facility Registration” section, FSMA clarifies the types of
businesses that should be considered to be “retail food establishments” and specifies that roadside
stands, farmers’ markets, and foods sold through a community-supported agriculture (CSA)
program also are not subject to the requirements.
It is difficult to estimate what share of all food processing operations might be exempt from the
new HACCP requirements, how many farms might be exempt from the new produce standards,
or how other small business considerations might possibly mitigate the effects of these and other
requirements in the new law. In part, this is because the definition of small and very small
business would be determined by HHS in future agency rulemaking and subject to other
requirements specified in the measures (see, for example, §§ 103, 105, and 204). Even though
farms would continue to be exempt from the facility registration requirements, some farms that
also engage in food processing might be affected, but data are not available on what share of
farms also engage in food processing. In addition, other stipulations in FSMA require that the
foods sold from exempted facilities and farms be sold locally and to certain qualified end-users.
Data are not available to determine what share of grower-processors might qualify for such an
exemption; such a determination will likely be made on a case-by-case basis.
Targeting of Inspections
Reform advocates had long argued that many recent problems leading to illness outbreaks and
recalls might have been avoided if inspectors were more frequently present in plants to monitor
sanitary conditions and processes.54 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. Prior to FSMA,
FFDCA authorized but did not require FDA to inspect food facilities. Therefore, periodic
inspection frequencies were not stipulated, although nothing appeared to prohibit FDA from
setting an inspection frequency, or prioritizing inspections based on risk.
Leading up to passage of FSMA, some, including former and current FDA officials, argued that
the agency lacked 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
54
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.
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facilities.55 (See Table 1.) According to FDA budget documents, while the number of registered
facilities increased each year from FY2004 to FY2010, the number of food inspectors decreased
by about 15% from FY2004 to FY2008. Due in part to the resource arguments, appropriations for
the agency’s field activities and full-time equivalents (FTEs) rose each fiscal year from FY2007
to FY2010.56 The number of inspections of food facilities increased each year between FY2008
and FY2010, but remained below FY2004 levels.
Table 1. FDA Food-Related Inspection Data, FY2004-FY2010
(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
Field S&E
($millions)a
$299.3
$283.3
$285.3
$298.0
$340.6
$479.9
$546.8
Field FTEsa
2,172
2,059
1,962
1,806
1,861
2,166
2,516
Inspectionsb
21,876
19,774
17,730
17,038
16,277
17,972
19,024
Domestic
Facilitiesc
92,719
104,555
115,902
129,345
141,703
154,883
164,805d
Foreign
Facilitiesc
121,534
148,451
172,190
194,245
214,584
236,398
252,433d
Source: Compiled by CRS from FDA annual budget documents for FY2006-FY2012. This table extends through
FY2010, the most recent year for which actual numbers are available.
a.
Food field S&E and FTE data are actual numbers, and are from the FY2007-FY2012 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.”
b.
Inspection data are actual numbers of “Grand Total Food Establishment Inspections” (which include FDA
and State Contract Inspections), from the FY2006-FY2012 annual Food and Drug Administration, President’s
Budget Request, Field Activities—Office of Regulatory Affairs (ORA), “Field Foods Program Activity Data.”
c.
Source: FDA Office of Legislation on September 22, 2010.
d.
Number of registrants as of September 22, 2010.
A related issue raised during the food safety debate in the 111th Congress was how FDA could
best target its available inspection resources to protect the public health. Different facilities might
not merit the same frequency of inspection. For example, facilities that process and package food
might create a greater opportunity for contamination than warehouses that merely store foods.
Companies and facilities that have a record of meeting all FDA requirements might present less
of a risk than those that do not. Foods produced in countries with food processing and handling
55
See, e.g., William Hubbard, 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.
56
In FDA budget documents, inspection-related items appear under the field heading, and employees are counted as
FTEs.
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standards at least as rigorous as those of the United States might present less of a health risk than
those with less rigorous standards.
FSMA Provisions. FSMA requires the HHS Secretary to increase the inspection rate for any food
facility required to register under FFDCA § 415. In addition, the Secretary is required to identify
high-risk facilities and to allocate resources to inspect facilities according to known safety risks.
Risks include the type of food, the facility’s history of food recalls, the facility’s hazard analysis
and preventive controls, and others. The new law requires the Secretary to inspect domestic highrisk facilities not less than once in the five-year period following enactment, and not less than
once every three years thereafter. The Secretary is 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 is 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 is authorized to
rely on inspections conducted by other federal, state, or local agencies.
For foreign food facilities registered under FFDCA § 415, FSMA permits the Secretary to enter
into arrangements and agreements with foreign governments to facilitate the inspection of those
facilities. The Secretary is 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 are to be refused
entry into the United States if inspectors are 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 new law requires 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. It requires 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.
With regard to seafood and other fish products, FSMA includes three specific provisions:
establishing interagency agreements to improve seafood safety (§ 201); assessing changes to
regulations for post-harvest processing of raw oysters (§ 114); and sending inspectors to assess
production of seafood imported into the United States (§ 306). The scope of interagency
agreements identified in § 201 includes examining and testing seafood; coordinating inspections;
standardizing data; modifying existing processes; sharing enforcement and compliance
information; and conducting joint training and outreach. Section 114 requires that two reports
(one by the Secretary of HHS and one by the GAO) be submitted to Congress and published
when the Secretary issues guidance, regulation, or suggested amendments related to post-harvest
processing of oysters. The requirement for the Secretary’s report is waived if a consensus
agreement is reached among federal and state regulators and the oyster industry, acting through
the Interstate Shellfish Sanitation Conference. Section 306 permits the Secretary of Commerce, in
coordination with the Secretary of HHS, to send inspector(s) to a country or facility of an
exporter of seafood imported into the United States to assess practices and processes used in
farming, cultivation, harvesting, preparation for market, and transportation of seafood. Inspectors
also may provide technical assistance related to these activities. For each inspection, the Secretary
of HHS must prepare and deliver a report to the subject of the inspection, which may then provide
a rebuttal or other comments as specified.
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Use of Third Parties for Imports and for Laboratory Accreditation
Prior to passage of FSMA, FDA lacked express statutory authority to regulate private laboratories
that sample or test imported foods, nor did it have authority to accredit food laboratories or use
others to certify the safety of imported foods. Laboratory accreditation was voluntary, and several
domestic and international accreditation organizations could accredit laboratories.57 FDA may
conduct voluntary, on-site assessments of private accredited laboratories.58 FDA’s own
laboratories are accredited and, according to FDA, “the laboratory industry favors
accreditation.”59 Industry participation in third-party certification programs, such as those that
help foreign and domestic producers meet FDA requirements through certification, has been
voluntary, although FDA has indicated that participation in such programs may “be beneficial.”60
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.”61
GAO 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.”62 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. 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.”63 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 FDA, to whether test results accurately reflect all information
obtained, such as evidence of FFDCA violations, to potential or actual conflicts of interest.
Additionally, critics have contended 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 recent recalls—the recall of 380 million eggs by a single
57
FDA, “Guidance for Industry: Submission of Laboratory Packages by Accredited Laboratories ,” 74 Federal Register
3056-3057, January 16, 2009, hereinafter Draft Guidance.
58
Ibid.
59
Ibid.
60
FDA, “Guidance for Industry: Voluntary Third-Party Certification Programs for Foods and Feeds ,” 74 Federal
Register 3058-3059, January 16, 2009.
61
Ibid.
62
Draft Guidance, 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, p. 7).
63
Ibid.
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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.64
FSMA Provisions. FSMA addresses various ways to curb the potential for such problems through
laboratory accreditation and third-party certification programs. FSMA (§ 303) creates a system of
accreditation of third-party auditors and audit agents, who certify that importing entities are
meeting applicable FDA requirements. Foreign governments, foreign agricultural cooperatives,
and other third parties can apply to an accreditation body to be a third-party auditor or audit
agent, after the accreditation body performs certain reviews. Accreditation bodies cannot 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 thirdparty auditors or audit agents are required to issue audit reports and to 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 new law also contains language regarding revocation of
accreditation and avoidance of conflicts of interest. The question remains as to whether industry
will opt to use third parties.
FSMA (§ 202) also includes provisions that require the Secretary to establish a program for
testing of food by accredited laboratories and to recognize accreditation bodies to accredit
laboratories, including state and local government laboratories. It requires the development of
model accreditation standards, as well as re-evaluation of accreditation bodies at least every five
years, and it requires that laboratory test results be sent to 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
Prior to passage of FSMA, neither FDA nor FSIS had explicit statutory authority to mandate a
recall of most adulterated foods, or to impose penalties if recall requirements were violated. FDA
could order food recalls only for infant formula.65 GAO and others contended that these gaps
increased the possibility that unsafe food would not be recovered, and would be consumed.66
Reversing their earlier opposition, many major food industry groups endorsed legislative
proposals to grant FDA mandatory recall authority for food.67
64
FDA, Update on the Salmonella Typhimurium Investigation, FDA/CDC Joint Media Teleconference, (Jan. 28,
2009), p. 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), p. B1.
65
FDA had the authority to order recalls of four types of products: infant formula, medical devices, human tissue
products, and tobacco products. The agency could 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.
66
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.
67
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.
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FSMA Provisions. FSMA (§ 206) requires 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 does not do so “within the time and in the
manner prescribed by the Secretary,” authority is provided to require such person to cease
distribution, or to immediately notify everyone involved in handling or receiving the food. The
Secretary is 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 law provides for the assessment of civil penalties as well as
criminal penalties for 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
Notification and traceability are viewed as tools to make recalls more effective. Some had 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 was also 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.68
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) requiring the responsible party for a
food facility (i.e., one 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 requiring the
Secretary to establish a Reportable Food Registry of such reports.69 Also, the enacted 2008 farm
bill (P.L. 110-246) amended the meat and poultry laws to require an establishment to notify
USDA if it has reason to believe that an adulterated or misbranded product has entered
commerce. (See also the earlier discussion of record-keeping requirements under FFDCA § 414.)
FSMA Provisions. FSMA (§ 211) amends 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. It also
requires 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.
68
See, for example, documentation on the 2010 Wright County egg recall available at the House Committee on Energy
and Commerce website: “Chairmen Request More Details on Salmonella Contamination at Wright County Egg
Publications,” September 14, 2010. See also discussion of the melamine contamination incident in CRS Report
R40916, Food Safety: Foodborne Illness and Selected Recalls of FDA-Regulated Foods.
69
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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FSMA (§ 204) also provides for an enhanced food tracing system that requires the Secretary,
through rulemaking, to impose enhanced record-keeping requirements (under FFDCA § 414) for
foods that the Secretary determines to pose a higher food safety risk. Low-risk foods may be
exempted. A number of limitations of such requirements are stipulated, especially with respect to
farms and agricultural commodities. Effective dates for the record-keeping requirements are
delayed for small businesses. The Secretary is also required to conduct pilot studies and
assessments of food tracing systems to inform the rulemaking process.
Foodborne Illness Surveillance and Outbreak Response
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. A
foodborne disease outbreak is not defined in law or in regulations. In 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.”70 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.71 The ability to link seemingly unrelated
illnesses through genetic “fingerprinting” has revolutionized the identification of large multistate
outbreaks. However, the epidemiological approaches used to identify the food associated with an
outbreak can be labor-intensive and time-consuming. Also, especially for FDA-regulated foods,
information about common contaminants that may be present in foods during production and in
commerce, as well as how to test for them, is limited. As a result, “attribution”—identifying the
types of foods that cause foodborne illnesses—remains a significant challenge. The 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.72
FSMA Provisions. FSMA (§ 205) contains provisions that, 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 law requires 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. It also contains provisions to establish a working group to improve foodborne illness
surveillance and outbreak investigations, and to reauthorize food safety capacity-building grants
70
CDC, “Surveillance for Foodborne-Disease Outbreaks–United States, 2007,” Morbidity and Mortality Weekly Report
(MMWR), vol. 59, pp. 973-979, August 13, 2010.
71
See CRS Report R40916, Food Safety: Foodborne Illness and Selected Recalls of FDA-Regulated Foods.
72
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.
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to states and Indian tribes under the PHS Act. It authorizes the appropriation of $24 million for
each fiscal year for FY2011-FY2015 for efforts to enhance foodborne illness surveillance.
Criminal Penalties
Under pre-existing law, the concepts of “adulteration” and “misbranding” are two basic statutory
components of 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 FFDCA by, for example, introducing an adulterated or misbranded product
into interstate commerce, commit what is referred to as a prohibited act under FFDCA § 301.73
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 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.74
Upon conviction for a misdemeanor violation of the prohibited acts section, a person75 faces the
penalties authorized in FFDCA § 303(a).76 These are presented in Table 2. 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 penalty 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.77
73
21 U.S.C. § 331.
See U.S. Congress, House Committee on Energy and Commerce, How Do You Fix Our Ailing Food Safety System,
111th Cong., 1st sess., March 11, 2009 (http://democrats.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).
75
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.
76
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 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).
77
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.
74
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Table 2. Criminal Penalties for Violations of FFDCA § 303(a)
Statute
Description of Statutory
Provision
Maximum Criminal Penalty
for Individuals (as adjusted by
18 U.S.C. §§ 3559 and 3571)
Maximum Criminal
Penalty for Organizations
(as adjusted by 18 U.S.C.
§§ 3559 and 3571)
Federal Food, Drug,
and Cosmetic Act
(FFDCA) § 303(a)(1)
(21 U.S.C. § 333(a)(1))
Violation of FFDCA
prohibited acts provisions,
FFDCA § 301
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
$200,000 if the offense does
not result in death, $500,000
if the offense results in death
FFDCA § 303(a)(2)
(21 U.S.C. § 333(a)(2))
Violation of FFDCA
prohibited acts provisions
after a prior conviction under
FFDCA § 303 or a violation
committed with the intent to
defraud or mislead
Imprisonment for not more than
three years or a fine of not more
than $250,000, or both
A fine of not more than
$500,000
Source: Prepared by CRS.
A violation of FFDCA’s prohibited acts section is a felony offense if it occurs after a prior
conviction for violating FFDCA’s prohibited acts section or if it is committed with the intent to
defraud or mislead. The maximum criminal penalty for individuals convicted of a felony violation
of 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 FFDCA, or
who conspire to violate 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.78 The decision to seek criminal sanctions against individuals
and corporations suspected of violating FFDCA is within FDA’s discretion.79 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.”80
FSMA Provisions. FSMA does not alter the criminal or civil penalties under FFDCA. During the
food safety debate in Congress, another Senate bill, S. 3767 (the Food Safety Accountability Act
of 2010, as introduced by Senator Patrick Leahy), was considered for inclusion in the final Senate
version of the food safety bill (S. 510). The provisions of S. 3767 would have amended the
penalties provisions of FFDCA § 303(a) to provide for fines and a maximum prison sentence of
10 years, if a person knowingly violated FFDCA’s prohibited acts section.81 However, these
provisions were not included in the final enacted law.
78
18 U.S.C. §§ 2, 371.
Heckler v. Chaney, 470 U.S. 821 (1985) (holding that “[t]he FDA’s decision not to take the enforcement actions
requested by respondents is therefore not subject to judicial review under the [Administrative Procedure Act]” and that
FFDCA enforcement provisions do not overcome the agency’s “decisions not to institute proceedings”).
80
FDA, Regulatory Procedures Manual, § 6-5-1, March 2010, http://www.fda.gov/ICECI/ComplianceManuals/
RegulatoryProceduresManual/ucm176738.htm.
81
S. 3767, as reported, would have amended 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 FFDCA’s prohibited acts
section, provided that the knowing violation be “with respect to food and with conscious or reckless disregard of a risk
(continued...)
79
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FSMA creates a new FFDCA § 1012 prohibiting food businesses from discharging or otherwise
discriminating against an employee who provides or causes to be provided information relating to
violations of FFDCA. This would include employees who testify, assist, or participate in a
proceeding on such a violation, or who refuse to participate in an activity reasonably believed to
violate the FFDCA. The new law also contains extensive language on the procedures for treating
and protecting whistleblowers.
Dietary Supplements
Survey data show that about half of American consumers report using dietary supplements.82
Supplements are subject to routine regulations for foods under FFDCA (including new
requirements under FSMA, such as mandatory recall authority). Supplements are also subject to
an additional set of regulations under the Dietary Supplement Health and Education Act of 1994
(DSHEA), as amended. Among other things, DSHEA requires that manufacturers and distributors
who wish to market supplements that contain “new dietary ingredients” (those not marketed in
the United States in a dietary supplement before October 15, 1994) notify FDA about these
ingredients. Since passage of DSHEA, some confusion has existed regarding the criteria for
defining new dietary ingredients and evaluating their safety. Also, there is growing concern about
the illegal addition of anabolic steroids to certain performance enhancing supplements.83
FSMA Provisions. In addition to the general provisions of FSMA that apply to most foods,
including supplements, FSMA includes two provisions specifically focused on supplements (both
found in FSMA, Section 113). The first provision requires FDA to notify the Drug Enforcement
Administration (DEA) if, when reviewing the safety of a new dietary ingredient, FDA determines
that the ingredient may contain an anabolic steroid or its analogue. (DEA regulates anabolic
steroids as controlled substances.84) The second provision requires that FDA publish guidelines,
within 180 days of enactment, to clarify the definition of a new dietary ingredient, and explain
how a product so categorized is to be evaluated for safety.
(...continued)
of death or serious bodily injury.” The maximum criminal penalty for individuals convicted of a felony violation of
FFDCA for knowingly violating these parts of 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 have been 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 not be more than $500,000.
82
Centers for Disease Control and Prevention, National Center for Health Statistics, National Health and Nutrition
Examination Survey (NHANES), key statistics, Table 96, “Dietary supplement use among persons 20 years of age and
over ..., United States, ... 2003–2006,” http://www.cdc.gov/nchs/data/hus/hus09.pdf#096.
83
Testimony of Michael Levy, FDA Center for Drug Evaluation and Research, U.S. Congress, Senate Committee on
the Judiciary, Subcommittee on Crime and Drugs, hearing on “Body-building Products and Hidden Steroids:
Enforcement Barriers,” 111th Cong., 1st sess., September 29, 2009, http://www.fda.gov/NewsEvents/Testimony/
ucm071783.htm.
84
CRS Report RL34635, The Controlled Substances Act: Regulatory Requirements.
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The FDA Food Safety Modernization Act (P.L. 111-353)
Food Imports
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.85 FDA import alerts in 2007 and 2008
targeting adulterated pet food ingredients, farmed seafood, and dairy products and ingredients, all
from China, are 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.86
Before enactment of FSMA, FFDCA (21 U.S.C. § 381(a)) empowered 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, under the provisions
of the Bioterrorism Act, the agency relied on a system of prior notifications by importers and
document reviews at ports of entry. Importers needed an entry bond and had to file a notification
for every shipment. An FDA database, the Operational and Administrative System for Import
Support (OASIS), helped inspectors to determine a shipment’s relative risk and whether it needed
closer scrutiny (i.e., a physical examination, and/or testing). In practice, import inspections were
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.87 Among the cited reasons for this low incidence of
inspections were limited and declining resources, including too few inspectors to cover the more
than 360 U.S. ports of entry despite ever-increasing import volumes.88 Prior law did not explicitly
authorize, or require, import verification.
FSMA Provisions. FSMA provisions on food imports (Title III) place tighter controls over
imports, and use certification or verification systems involving so-called third parties. FSMA
(§ 303) authorizes 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 are to
be used for designated food imported from countries where FDA has an agreement for a
certification program. Certifying entities include an agency or representative from the originating
country or other persons accredited elsewhere (see section titled “Use of Third Parties for Imports
and for Laboratory Accreditation”).
FSMA (§ 301) authorizes a “Foreign Supplier Verification Program,” generally requiring each
importer to perform foreign supplier verification activities in accordance with regulations the
Secretary may issue to ensure compliance with relevant FFDCA provisions. Each importer’s
85
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 Center for
Science in the Public Interest, “Building a Modern Food Safety System for FDA Regulated Foods,” May 2009.
86
Additional information is available in CRS Report RL34198, U.S. Food and Agricultural Imports: Safeguards and
Selected Issues.
87
FDA briefing for Senate staff, February 8, 2008. FDA FY2009 budget materials state that 94,743 import food field
exams were conducted in FY2007.
88
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 FDA Food Safety Modernization Act (P.L. 111-353)
program will 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 to requirements of other relevant provisions of FFDCA. Verification activities
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 are required to maintain import verification program records for at least two
years and to make them available to the Secretary upon request.
Other FSMA provisions include 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. The law also requires the establishment of a
program to expedite imports from those who voluntarily agree to certain higher safety standards
under the “Voluntary Qualified Importer Program” (§ 302).
Some have questioned whether FSMA will provide FDA with so-called “equivalence authority,”
such as that governing U.S. imports of meat and poultry products under USDA’s FSIS
jurisdiction. “Equivalency” refers to the requirement that all imported meat and poultry products
meet all safety standards applicable to similar products produced in the United States. Foreign
meat and poultry food regulatory systems may apply “equivalent sanitary measures to eliminate
or abate food safety hazards” if those measures provide the same “level of public health
protection” achieved by U.S. measures.89 Under laws governing meat inspection,90 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 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.91 How FDA is able to exercise its new authority
under FSMA regarding food imports under the agency’s jurisdiction remains to be seen.
89
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.
90
Federal Meat Inspection Act, 21 U.S.C. §§ 601-695; and Poultry Products Inspection Act, 21 U.S.C. §§ 451-471.
91
See, for example, testimony of Caroline Smith DeWaal, Director of Food Safety, Center for Science in the Public
Interest, before the House Energy and Commerce Committee’s Subcommittee on Oversight and Investigations, July 17,
2007.
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The FDA Food Safety Modernization Act (P.L. 111-353)
Paying for Food Safety with User Fees
Many critics have argued that a fundamental problem has been FDA’s lack of sufficient funding
and staff to carry out congressionally mandated (and existing) responsibilities to ensure a safe
food supply.92 Responding to a request from Democratic leaders of the House Energy and
Commerce Committee, a subcommittee of the FDA Science Board93 estimated that, in order to
address these deficiencies, the food-related portion of FDA’s appropriation should be increased.94
In fact, congressional appropriators increased funding for FDA food activities each year from
FY2005 to FY2010.95 (See Table 3.)
Table 3. FDA Direct Appropriations for Foods, FY2005-FY2010
(dollars in millions)
Appropriations
FY2005
FY2006
FY2007
FY2008
FY2009
FY2010
435.5
438.7
457.1
507.8
712.8
783.2
Source: Compiled by CRS from FDA annual budget documents. Data are from the FY2007-FY2012 annual Food
and Drug Administration, President’s Budget Request, “All Purpose Table—Total Program Level.” All dollar
amounts are actual; FY2010 is the most recent year for which actual numbers are available.
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 is to fill perceived shortfalls through user fees on
the regulated industry. For several years before the introduction of FMSA, such user fees related
to foods had been proposed in legislation and in budget requests. For example, the President’s
FY2011 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.
Before FSMA added the authority for FDA to collect food-related user fees, the agency already
had the authority to collect user fees related to human and animal prescription drugs and human
medical devices (21 U.S.C. 379g - 379j-12);96 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
92
See, e.g., FDA Science Board, FDA Science and Mission at Risk: Report of the Subcommittee on Science and
Technology, November 2007.
93
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.
94
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.
95
See CRS Report R40792, Food and Drug Administration Appropriations for FY2010.
96
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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The FDA Food Safety Modernization Act (P.L. 111-353)
submitting certain applications to FDA. The fees collected are intended to fund approval-related
activities; with the exception of tobacco fees, they cannot be used to fund enforcement or
inspection activities for products on the market, except to a very limited extent. (Unlike foods and
some food additives, prescription drugs, medical devices, and animal drugs require FDA’s
advance permission before they can be legally marketed.) The user fee programs have generally
been authorized in five-year increments (except for tobacco fees, which are permanently
authorized). Each authorization specifies the fee amounts FDA may collect annually, among other
legislative direction.
Since before the FMSA was enacted, FDA has also been explicitly 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 these 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.97
The introduction of fees raises several issues. 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. 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 established.
Second, concerns are sometimes expressed that user fees, once authorized, comprise an everincreasing 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.98
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 cannot easily be increased or trimmed to conform to shortterm 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.99 In FY2007, in order to make user fee funding more
97
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 (Washington: GPO,
2002), pp. 30-31.
98
See CRS Report RL34334, The Food and Drug Administration: Budget and Statutory History, FY1980-FY2007.
99
See Barbara Zimmerman, Medical Device Review Program Performance, FDA, Webcast, 2010, http://www.fda.gov/
downloads/MedicalDevices/NewsEvents/WorkshopsConferences/UCM224256.wmv.
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The FDA Food Safety Modernization Act (P.L. 111-353)
consistent and reliable, certain annual fees (such as annual registration fees) were enacted to help
resolve the issue.100
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 devicerelated user fees have reductions for small businesses.
FSMA Provisions. FSMA funds some FDA food safety activities through the collection of user
fees. (See Table 4.) It establishes 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 annual and periodic fees are presented in Table 5,
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. FSMA does not impose
new facility registration fees.
Table 4. Fees in the FDA Food Safety Modernization Act (FSMA, P.L. 111-353)
FSMA, P.L. 111-353
Reinspection Fee
§ 107
Recall Fee
§ 107
Export Certification Fee
§ 401
VQIP Fee
§ 107
Source: Prepared by CRS.
Regarding fees, the Congressional Budget Office (CBO) estimated that over five years, the new
requirements would collect $241 million (based on an assessment of the August 2010 manager’s
amendment of the Senate version of the food safety bill).101 CBO also estimated that covering the
five-year cost of new requirements, including more frequent inspections, would require additional
outlays of $1.1 billion.102
100
Ibid., 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).
101
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.
102
Note that the CBO scores in this paragraph are specific to FDA costs. For that reason, they are somewhat lower than
amounts discussed earlier this report, which reflect estimated total federal costs.
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Table 5. Select Details of Fees Authorized in the FDA Food Safety Modernization Act (FSMA, P.L. 111-353)
VQIP Fee
Reinspection Fee
Recall Fee
Who pays
Importers participating in the
voluntary importer certification
program, under new FFDCA §
806.
If subject to reinspection in a
fiscal year: the responsible party
for a domestic facility (defined in
new FFDCA § 415(b)), the U.S.
registered agent for a foreign
facility, or the importer.
If noncompliant with a recall
order under FFDCA § 412(f) or
new § 423: the responsible party
for domestic facilities (defined in
new FFDCA § 415(b)), or the
importer.
Exporters who voluntarily
request and receive within 20
days Secretary’s export
certification under amended
FFDCA § 801(e)(4).
Fee Amount
Amounts estimated as specified
to cover 100% of the VQIP costs
for that year.
Secretary annually establishes
fees for facilities and for
importers so each fee covers
100% of the respective estimated
reinspection-related costs.
Secretary annually establishes
fees to cover 100% of estimated
cost of food recall activities
associated with such order
performed by the Secretary.
Fees may cover the cost of
issuing export certifications.
Fee Amount Cap
None.
The amount of fees collected
may not exceed $25 million in a
given FY, except that if a
domestic facility or importer
becomes subject to a fee in a
given year, the Secretary may
collect it.
The amount of fees collected
may not exceed $20 million in a
given FY, except that if a
domestic facility or importer
becomes subject to a fee in a
given year, the Secretary may
collect it.
Fee may not exceed $175 per
certification. Fees may not be
retained in an amount that
exceeds the cost of issuing
export certifications for the
respective fiscal year.
Result of Nonpayment
Fees over 30 days past due treated as a claim of the U.S. Government under 31 U.S.C., chapter 37,
subchapter II (Claims of the United States Government).
No provision in § 107.
How Funds May Be Used
For administering the VQIP
program.
For FDA’s export certification
costs.
Required Reports, Meetings
Secretary must: (1) publish within 180 days of enactment a proposed set of guidelines related to the
burden of fee amounts on small 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.
None.
Authorization
For FY2010 and each FY thereafter, an amount equal to the revenue amount determined as specified.
No provision in § 107.
Appropriations-Related
Restrictions on Fee
Collection
Fees must be refunded if appropriations for FDA’s food safety activities, excluding fees, are less than the
preceding year's appropriations adjusted for inflation, as specified.
None.
Expiration Date
None.
None.
For reinspection-related
activities.
None.
Source: Prepared by CRS based on the text of FSMA (P.L. 111-353).
CRS-31
For food-recall-related costs
associated with the recall order,
for activities performed by the
Secretary.
None.
Export Certification Fee
Appendix A. FDA Food Safety Modernization Act (P.L. 111-353) Provisions
Subject Matter
Section(s)
FDA Food Safety Modernization Act (FSMA), P.L. 111-353
Title I—Improving Capacity to Prevent Food Safety Problems
Record-keeping Requirements and FDA Access to Records
101
Inspections of Records (§ 101)
Facility Registration
102
Registration of Food Facilities
Hazard Prevention Plans
103
Hazard Analysis and Risk-Based Preventive Controls (§ 103)
Performance Standards
104
Performance Standards (§ 104)
Produce Safety Standards
105
Standards for Produce Safety (§ 105)
Intentional Adulteration and Domestic Food Defense
106, 108,
109, 110
Protection Against Intentional Adulteration (§ 106); National Agriculture and Food Defense Strategy (§
108); Food and Agriculture Coordinating Councils (§ 109); Building Domestic Capacity (§ 110)
Export Certification Fees
107
Authority to Collect Fees (§ 107)
Sanitary Transportation of Food
111
Sanitary Transportation of Food (§ 111)
Food Allergy and Anaphylaxis
112
Food Allergy and Anaphylaxis Management (§ 112)
Vitamins and Minerals Containing Anabolic Steroids
113
New Dietary Ingredients (§ 113)
Seafood
114, 103,
201, 306
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) ; Targeting of
Inspection Resources for Domestic Facilities, Foreign Facilities, and Ports of Entry; Annual Report (§
201); Inspection of Foreign Food Facilities (§ 306)
Port Shopping
115
Port Shopping (§ 115)
Jurisdiction
116
Alcohol-Related Facilities (§ 116)
Title II—Improving Capacity to Detect and Respond to Food Safety Problems
Inspection of Facilities
201
Targeting of Inspection Resources for Domestic Facilities, Foreign Facilities, and Ports of Entry; Annual
Report (§ 201)
Laboratory Accreditation
202
Recognition of Laboratory Accreditation for Analyses of Foods (§ 202)
Other Laboratory Provisions
203
Integrated Consortium of Laboratory Networks (§ 203)
Traceability of Food
204
Enhancing Tracking and Tracing of Food and Recordkeeping (§ 204)
Foodborne Illness Surveillance and Education
205
Surveillance (§ 205)
Mandatory Recall Authority
206
Mandatory Recall Authority (§ 206)
Administrative Detention of Food
207
Administrative Detention of Food (§ 207)
CRS-32
Subject Matter
Food Decontamination and Disposal
State and Local Food Safety Roles and Training
Section(s)
208
209, 210
FDA Food Safety Modernization Act (FSMA), P.L. 111-353
Decontamination and Disposal Standards and Plans (§ 208)
Improving the Training of State, Local, Territorial, and Tribal Food Safety Officials (§ 209); Enhancing
Food Safety (§ 210)
Research
210
Food Safety Integrated Centers of Excellence (§ 210)
Reportable Food Registry
211
Improving the Reportable Food Registry (§ 211)
Foreign Supplier Verification
301
Foreign Supplier Verification Program (§ 301)
Expediting Imports
302
Voluntary Qualified Importer Program (§ 302)
Import Certification
303
Authority to Require Import Certifications for Food (§ 303)
Prior Notice of Imports
304
Prior Notice of Imported Food Shipments (§ 304)
Foreign Capacity Building
305
Building Capacity of Foreign Governments with Respect to Food (§ 305)
Inspection of Foreign Facilities
306
Inspection of Foreign Food Facilities (§ 306)
Third Party Accreditation
307
Accreditation of Third-Party Auditors (§ 307)
FDA Foreign Offices
308
Foreign Offices of the Food and Drug Administration (§ 308)
Smuggled Food
309
Smuggled Food (§ 309)
Funding and Fees
401
Authority to Collect Fees (§ 107); Funding for Food Safety (§ 401)
Whistleblower Protection
402
Employee Protections (§ 402)
Title III—Improving the Safety of Imported Food
Title IV—Miscellaneous Provisions
Jurisdiction
Pay-As-You-Go
Source: Table created by CRS.
CRS-33
403, 404
405
Jurisdiction; Authorities (§ 403); Compliance With International Agreements(§ 403)
Determination of Budgetary Effects (§ 405)
Appendix B. Comparison of Provisions in the FDA Food Safety Modernization
Act (FSMA, P.L. 111-353), with Previously Existing Law
Background, Applicable Law, and Administration Statements
FDA Food Safety Modernization Act (FSMA), P.L. 111-353
Title I—Improving Capacity to Prevent Food Safety Problems
Records Inspection. Many advocates of reform argue that recordkeeping
requirements must be strengthened to improve the ability of regulators to
determine whether firms are complying with the law and to facilitate efforts to
find the source of problems (including during product recalls) when they occur.
One of their concerns has been that records are not required to be maintained
in electronic format, which if required, these advocates assert, would greatly
speed outbreak response. Related issues include the types of records to be
kept, how detailed they should be, how long they should be kept, and access
and use of these records by authorities. For example, are the current legal
premises for accessing records (see below), adequate? Proposals for increased
recordkeeping requirements often raise questions about the intrusiveness of
government, privacy concerns, and the protection of sensitive commercial
information (trade secrets), for example.
The Federal Food, Drug, and Cosmetic Act (FFDCA; 21 U.S.C. §§ 301 et seq.)
§ 414 currently authorizes the Secretary, by regulation, to require that food
establishments (except farms and restaurants) maintain certain records
regarding foods, including immediate previous sources, and immediate
subsequent recipients.“If 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,” such records must be made
available for inspection and copying upon written notice. The Secretary is
required to take appropriate measures to ensure that unauthorized disclosure
of any trade secret or confidential information is prevented.
Obama Administration: The Food Safety Working Group (FSWG) stated that
the Administration would work with Congress on “critical legislation that will
provide key tools ... . to keep food safe.” One tool it cited was “the ability to
access basic food safety records at facilities.”
CRS-34
Inspections of Records (§ 101)
Amends FFDCA § 414, which contains one standard (trigger) for records access, by creating two
such standards. The first is somewhat similar to current law by authorizing access “(i)f the Secretary
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...” The second standard
authorizes access “(i)f 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...” It appears that by invoking the second standard, the Secretary would no longer
be required to have a reasonable belief that a food is adulterated in order to have access to records.
Also apparently new under both standards would be the ability to access records if “any other article
of food” could be similarly affected, such as food produced on the same manufacturing line as an
implicated food, or food produced using implicated ingredients. Under either trigger, a designee of
the Secretary is to be granted access to records upon presentation of appropriate credentials and a
written notice to such person, at reasonable times and within reasonable limits and in a reasonable
manner. Requirements apply to all records relating to the manufacture, processing, packing,
distribution, receipt, holding, or importation of a food, in any format (including paper and electronic
formats), and at any location. No specific format is required. Farms and restaurants would continue
to be excluded under FFDCA § 414.
Background, Applicable Law, and Administration Statements
FDA Food Safety Modernization Act (FSMA), P.L. 111-353
Facility Registration. Some assert that registration requirements should be
strengthened so that FDA is notified when a firm moves, undertakes a new
food business, or changes product lines. Otherwise, the FDA’s records on what
facilities 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 the industry.
Registration of Food Facilities (§ 102)
Both domestic and foreign food facilities are required to register with FDA
pursuant to FFDCA § 415. Farms, restaurants, other retail food establishments,
and most nonprofit food establishments and fishing vessels are excluded from
the requirement. Renewal is not required on any periodic basis, but registrants
must notify the Secretary in a timely manner of any relevant changes in their
status. FFDCA § 301(dd) designates failure to register as a prohibited act.
FFDCA § 801(l) provides that imported food may not be delivered to the
importer, owner, or consignee of the article until the foreign facility is
registered. FDA does not have explicit authority to require a registration fee.
Amends FFDCA § 415 to require biennial facility registration, with an abbreviated process for
registrants whose information has not changed. Registrants are required to provide additional
contact information, including an e-mail address and, for foreign facilities, the United States agent for
the facility. Registrants must also provide an assurance that the Secretary will be permitted to inspect
the facility. The Secretary is authorized or required to suspend and/or reinstate registrations, based
on the Secretary’s determination that “food manufactured, processed, packed, 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” for a facility that “created, caused, or was otherwise
responsible” or “that knew of, or had reason to know of, such reasonable probability.” Delineates an
appeal process, including a requirement for an informal hearing generally within two business days,
and procedures for submission of a corrective action plan and for lifting a suspension. The Secretary
shall review corrective action plans “not later than 14 days after the submission” of such plans. The
Secretary also shall promulgate regulations regarding suspension and reinstatement procedures. If its
registration is suspended, a facility may not import food, or introduce food into interstate or
intrastate commerce, in the United States. The Secretary’s authority to suspend registration shall not
be delegated to anyone other than the FDA Commissioner. The Secretary may require that
registration be submitted electronically, but not earlier than 5 years after enactment.
Provides consideration of small businesses. Requires the Secretary to issue a ”small entity compliance
policy guide” setting forth the requirements of such regulations to assist small entities in complying
with the registration requirements and other activities (no later than 180 days after the issuance of
the regulations under this section). Requires the Secretary to amend the definition of “retail food
establishment” (21 CFR 1.227(b)(11)) to clarify that, in determining the primary function of such an
establishment, the sale of food directly to consumers would include sales by a roadside stand or
farmers’ market, sales through a community supported agriculture (CSA) program, or other types of
direct food sales as determined by the Secretary.
Hazard Analysis. A broad consensus of policymakers agrees that FDA’s
system of safeguards, which is based on a law first written early the last century,
is primarily reactive. By and large, the agency's statute and regulations spell out
the reasons a food article is to be considered adulterated or misbranded and
therefore unfit for consumption. In effect, industry players are expected to
abide by the rules; generally it is only when a problem is detected—often after
an illness outbreak is reported or testing finds a contaminant in a product—that
officials step in to correct it, or order the industry to do so. Virtually all
stakeholders, including regulators, the regulated industries, consumer
advocates, and food safety scientists now 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.
Hazard Analysis and Risk-Based Preventive Controls (§ 103)
FDA currently requires that managers of certain food facilities—those
producing or processing seafood, some juices, and low-acid canned foods—
• implementing corrective actions if controls are found, through monitoring, not to have been
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Establishes a new FFDCA § 418, requiring the owner, operator, or agent in charge of a facility to
develop a written plan and carry out certain preventive activities in the plan, including:
• conducting an analysis to identify and evaluate known or reasonably foreseeable hazards that may
be associated with the facility, hazards that may be intentionally introduced, including by acts of
terrorism; and preparing a written analysis;
• identifying and implementing preventive controls, including at critical control points, if any, to
provide assurances that identified hazards will be prevented or minimized, and that food is not
adulterated or misbranded;
• developing a means to verify the effectiveness of these preventive controls;
Background, Applicable Law, and Administration Statements
FDA Food Safety Modernization Act (FSMA), P.L. 111-353
prepare Hazard Analysis and Critical Control Point (HACCP) plans for their
operations. HACCP is a preventive approach that incorporates hazard analysis,
appropriate process controls, verification, and other steps throughout the
production process. A cornerstone of HACCP is the identification of hazards
by industry that are “reasonably likely to occur.” The emphasis on hazards that
are reasonably likely to occur assures that such hazards—such as microbial
contamination in fresh juices, or botulism in low-acid canned foods—are
systematically and consistently addressed.
effective (specifies that corrective actions ensure “(1) appropriate action is taken to reduce the
likelihood of recurrence of the implementation failure; (2) all affected food is evaluated for safety; and
(3) all affected food is prevented from entering into commerce if the owner, operator or agent in
charge of such facility cannot ensure that the affected food is not adulterated,” as defined by law)
There is no explicit statutory authority or requirement regarding HACCP
systems for FDA-regulated foods. FDA regulations requiring HACCP plans and
systems for seafood, fruit and vegetable juices, and low-acid canned foods cite
the applicable statutory authority as FFDCA § 402(a), which defines
adulteration, and the Secretary’s general authority to promulgate regulations to
assure the safety of foods, as FFDCA § 701(a).
At the U.S. Department of Agriculture, the Food Safety and Inspection Service
(FSIS) in 1996 began implementing rules to establish a mandatory HACCP for
meat and poultry, using its authority to regulate major meat and poultry species
under the Federal Meat Inspection Act (FMIA) and Poultry Products Inspection
Act (PPIA). Record keeping and verification are used to ensure that the system
is working. Following a phase-in period to accommodate smaller-sized
establishments, and since January 2000, all slaughter and processing operations
have been required to have HACCP plans in place. HACCP is intended to
operate as an adjunct to the traditional methods of facility inspection, which still
are mandatory under the original statutes.
Obama Administration: The Administration's FSWG stated that the
Administration would work with Congress on “critical legislation that will provide
key tools .... to keep food safe.” One tool it cited was the ability to require sanitation
and preventive controls at food facilities, based on a scientific hazard analysis.
• verifying that preventive controls are effective, that monitoring is ongoing, that corrective actions
are taken when needed, and that the plan is periodically reviewed for continued relevance;
• keeping and maintaining, for at least two years, records documenting the monitoring of preventive
controls, relevant instances of nonconformance, instances when corrective actions were
implemented, and the efficacy of preventive controls and corrective actions.
Applicable definitions are provided in this section for “critical control point,” “facility,” and
“preventive controls.” The required plan and associated documentation of performance must be
made promptly available to an authorized representative of the Secretary upon oral or written
request. The hazards must be reanalyzed at least every three years, or sooner if there is a change in
processes or practices that could create or worsen a hazard. The Secretary may require a revision of
the plan based on a new hazard or new scientific information, including, as appropriate, “results from
the Department of Homeland Security biological, chemical, radiological, or other terrorism risk
assessment.” Failure to comply with the section’s requirements is prohibited under FFDCA § 301.
Seafood, juice, and low-acid canned-food facilities that are already in compliance with applicable FDA
regulations are deemed to be in compliance with this section. Facilities subject to requirements in
FFDCA § 419, as established by this act (regarding safety standards for produce), are not subject to
this section. The Secretary may, by regulation, exempt or modify the requirements of this section for
facilities that are solely engaged in the production of food for animals other than man, the storage of
raw agricultural commodities (other than fruits and vegetables) intended for further distribution or
processing, or the storage of packaged foods that are not exposed to the environment. This section
does not limit the Secretary’s authority to revise, issue or enforce regulations for specific types of
foods, such as the HACCP regulations currently in effect for certain foods. This section does not
apply to dietary supplements.
Considering existing regulatory hazard analysis and preventive control programs to determine
applicable internationally recognized standards, the Secretary shall promulgate regulations not later
than 18 months after enactment regarding the implementation of requirements under this section,
and shall issue an applicable guidance document. Regulations shall be sufficiently flexible to be
applicable in all situations, including the operations of small businesses. This section does not provide
the Secretary with the authority to apply specific technologies, practices, or critical controls to an
individual facility.
Contains clarifying language regarding the promulgation of FDA regulations, including consideration
for various types of businesses and activities (on-farm and at processing facilities). Provides
consideration of small businesses. Requires the Secretary to issue a ”small entity compliance policy
guide” setting forth the requirements of such regulations to assist small entities in complying with the
registration requirements and other activities (no later than 180 days after the issuance of the
CRS-36
Background, Applicable Law, and Administration Statements
FDA Food Safety Modernization Act (FSMA), P.L. 111-353
regulations under this section), along with other flexibility and extended implementation deadlines
for small and very small businesses. Requirements become effective in stages according to the size of
the business: businesses must be compliant 18 months after the date of enactment, except small
businesses (as defined by the Secretary) are to have 2 years after enactment, and very small
businesses (as defined by the Secretary) 3 years after enactment. Certain facilities would not be
subject to the requirements. Food facilities would qualify for an exemption from the HACCP
requirements if they are either a “very small business” as defined by FDA in rulemaking, or if the
facility’s “average annual monetary value” of all food sold during the previous 3-year period was less
than $500,000, provided that the food is sold directly to “qualified end users” such as consumers,
restaurants, or retail food establishments that are located in the same state where the facility sold
the food or within 275 miles of the facility. Such a facility would need to demonstrate that it either
has “identified potential hazards associated with the food being produced,” and is implementing and
monitoring these preventive controls, or that it is “in compliance with State, local, county, or other
applicable non-Federal food safety law.” Foods produced from such a facility would also need to
provide the facility’s name and address on a food packaging label or at the point of purchase.
Requires FDA, with USDA, to conduct a study of the food processing sector.
Performance Standards. Performance standards are typically specific,
quantitative measurements of a property of, or a substance in, food. They may
apply strictly to the property being measured, or serve as benchmarks for
whether the food is safe in a broader sense. For example, a performance
standard for a single microbe might be used to determine whether a product is
contaminated with microbes in general. (This approach is sometimes called
process verification.) Such a finding could indicate a problem with the product’s
processing, and prompt a review of processing activities. FFDCA (in various
provisions in Chapter IV, regarding food) authorizes FDA to promulgate
standards for certain hazards, such as maximum permissible levels (called
tolerances) for residues of pesticides or drugs in foods. FFDCA does not grant
FDA the explicit authority to develop standards solely as a means to verify that
processing is carried out in a manner that assures the safety of the food.
Obama Administration: The Food Safety Working Group (FSWG),
established by the Administration in 2009, stated that the Administration would
work with Congress on “critical legislation that will provide key tools .... to
keep food safe.” One tool it cited was the ability to establish performance
standards to measure the implementation of proper food safety standards.
Produce Standards. As noted earlier, FFDCA authorizes FDA to promulgate
standards for certain hazards, some of which, such as maximum permissible
levels (called tolerances) for residues of pesticides, may apply to produce.
FFDCA does not grant FDA explicit authority to develop standards solely as a
means to verify that processing is carried out in a manner that assures the
safety of the food. FDA has several voluntary efforts in place to address safety
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Performance Standards (§ 104)
In coordination with the U.S. Department of Agriculture (USDA), the Secretary of the Department
of Health and Human Services (HHS) shall, at least every two years, review and evaluate relevant
health data and other relevant information, including epidemiological and toxicological data and other
appropriate information to determine the most significant foodborne contaminants.
Based 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 the food under FFDCA § 402 or the
spread of communicable disease under Public Health Service (PHS) Act § 361, the Secretary shall
issue contaminant-specific and science-based guidance documents, actions levels, or regulations. Such
standards shall apply to products and product classes, may differentiate between food for humans
and food for animals, and shall not be written to be facility-specific. HHS will coordinate with USDA
to avoid duplication of effort regarding guidance documents for the same contaminant. The Secretary
will issue and periodically review/revise all guidance documents and regulation.
Standards for Produce Safety (§ 105)
Subsection (a) of this section establishes a new FFDCA § 419, regarding safety standards for produce.
Within one year of enactment, the Secretary (in consultation with USDA and state agriculture
departments, including with regard to the national organic foods program, and in consultation with
DHS), is required to publish a notice of proposed rulemaking for science-based minimum standards
for the safe production and harvesting of those fruits and vegetables that are raw agricultural
Background, Applicable Law, and Administration Statements
FDA Food Safety Modernization Act (FSMA), P.L. 111-353
in the produce industry. For example, in February 2008, the agency issued the
final version of the Guide to Minimize Microbial Food Safety Hazards of Freshcut Fruits and Vegetables, which contains non-binding recommendations
regarding: primary production and harvesting of fresh fruits and vegetables;
personnel; buildings and equipment; sanitation operations; production and
process controls; documentation and records; traceback; and recall. On
September 2, 2008, FDA published a notice in the Federal Register seeking
comments and data to assist the agency in its revision, now underway, of its
1998 Guide to Minimize Microbial Food Safety Hazards for Fresh Fruits and
Vegetables. Also, FDA asserts that it has been engaged in efforts to identify
hazards commonly associated with fresh produce, and to develop tracking and
tracing methods.
commodities (including mixes and specific categories of fruits and vegetables), for which the
Secretary has determined that such standards minimize the risk of serious adverse health
consequences or death. The Secretary may exclude from such rulemaking commodities determined
to be low risk when produced or harvested by small or very small businesses. The Secretary shall
hold at least 3 public meetings on such rulemaking in diverse geographic areas.
Under the Agricultural Marketing Agreement Act of 1937 (7 U.S.C. § 601 et
seq.), producers and handlers can organize themselves under legally binding
marketing orders that can include quality (and possibly, safety) standards. The
act is overseen by USDA’s Agricultural Marketing Service (AMS). In an advance
notice of proposed rulemaking, AMS in October 2007 invited comments on
whether to create such a federal marketing program that specifically would
require handlers (packers, processors, shippers) of leafy greens, including
lettuce and spinach, to meet prescribed safety standards. A similar state order
was adopted by California growers in 2006.
Obama Administration: The FSWG announced, and FDA issued on July 31,
2009, new draft guidances on three specific types of produce: 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, which, when finalized (and as is the case for all FDA guidance
documents), will be nonbinding and will represent FDA’s current thinking on
these topics.
Proposed rulemaking shall “provide sufficient flexibility to be applicable to various types of
entities…including small businesses and entities that sell directly to consumers, and be appropriate to
the scale and diversity” of production and harvesting. The proposed rule also shall address minimum
standards for other specified elements, including soil amendments, hygiene, packaging, temperature
controls, animal encroachment and water, as well as hazards that occur naturally or that may have
been introduced, intentionally or unintentionally. The proposal shall take into consideration,
consistent with public health protection, “conservation and environmental practice standards and
policies established by Federal natural resource conservation, wildlife conservation, and
environmental agencies,” and also “in the case of production that is certified organic, not include any
requirements that conflict with or duplicate the requirements of” the national organic foods
program, while providing the same level of protection as required under this act. Priority is to be
given to those raw fruits and vegetables that have been associated with food-borne illness outbreaks.
Subsection (b) states that within a year of the closing of the comment period, the Secretary shall
adopt a final rule to provide for minimum standards for certain types of fruits and vegetables, as
needed to minimize the risk of serious adverse health consequences. Among other requirements, the
final rule shall provide for coordination of education and enforcement activities with state and local
officials, minimize recordkeeping burdens, and describe the variance process and the types of
permissible variances that the Secretary may grant to states and foreign countries to address local
growing conditions. Effective dates for compliance are phased in for small and very small businesses
(see below). The Secretary may coordinate with USDA and shall contract as appropriate with states
to conduct compliance activities. Not later than one year after enactment, the Secretary shall publish
updated good agricultural practices and guidance for the safe production and harvesting of specific
types of produce, after consultation with stakeholders (as specified). This section shall not apply to
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 FFDCA or the PHS Act [42 U.S.C. § 201 et
seq.] to revise, issue, or enforce product and category-specific regulations, such as those for existing
HACCP programs.
Small and very small businesses may be exempted from regulation if the Secretary has determined
these “are low risk and do not present a risk of serious adverse health consequences or death.”
Extended implementation deadlines for small and very small businesses apply: small businesses (as
defined by the Secretary) are to have 1 year after final regulation are promulgated, and very small
businesses (as defined by the Secretary) 2 years after final regulations. Requires the Secretary to
issue a ”small entity compliance policy guide” setting forth the requirements of such regulations to
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Background, Applicable Law, and Administration Statements
FDA Food Safety Modernization Act (FSMA), P.L. 111-353
assist small entities in complying with the registration requirements and other activities (no later than
180 days after the issuance of the regulations under this section), along with other flexibility for small
businesses. Requires the Secretary to ensure any updated guidance comply with the Paperwork
Reduction Act (PRA) and minimize regulatory burden and unnecessary paperwork and the number of
separate standards on the facility, among other clarification regarding acknowledgment of risk
differences and compliance burden. Certain farms would not be subject to the requirements. Farms
would qualify for an exemption from the HACCP requirements if the farm’s “average annual
monetary value” of all food sold during the previous 3 year period was less than $500,000, provided
that the food is sold directly to “qualified end users” such as consumers, restaurants, or retail food
establishments that are located in the same state where the facility sold the food or within 275 miles
of the facility. Foods produced from such
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