Food Safety Issues for the 112th Congress
Renée Johnson
Specialist in Agricultural Policy
February 10, 2011
Congressional Research Service
7-5700
www.crs.gov
R41629
CRS Report for Congress
P
repared for Members and Committees of Congress

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Food Safety Issues for the 112th Congress

Summary
The 111th Congress passed comprehensive food safety legislation in December 2010 (FDA Food
Safety Modernization Act (FSMA), P.L. 111-353). Although numerous agencies share
responsibility for regulating food safety, this newly enacted legislation focuses on foods regulated
by the Food and Drug Administration (FDA) and amends FDA’s existing structure and
authorities, in particular the Federal Food, Drug, and Cosmetic Act (FFDCA; 21 U.S.C. §§ 301 et
seq.). Among its many provisions, the new law expands FDA’s authority to conduct a mandatory
recall of contaminated food products, enhances surveillance systems for foodborne illness
outbreaks, establishes preventative controls at some food processing facilities and farms,
enhances FDA’s traceability capacity within the nation’s food distribution channels, increases the
number of FDA inspections at domestic and foreign food facilities, and expands FDA’s authority
and oversight of foreign companies that supply food imports to the United States.
The 112th Congress may provide oversight over how the law is implemented, including FDA’s
coordination with other federal agencies, such as those in the U.S. Department of Agriculture
(USDA) and the Department of Homeland Security (DHS). Implementation of the law will
depend largely on the availability of discretionary appropriations, and some have questioned
whether additional funding is available in the current budgetary climate.
In addition, the 112th Congress may continue to consider changes to other food safety laws and
policies that are being actively debated in Congress. Among these are food safety initiatives
covering meat, poultry, and seafood products; legislation intended to curtail the non-medical use
of antibiotics in animal feeds and to ban the use of certain plastic components commonly used in
food containers; food labeling; and the use of plant and animal biotechnology. Several of these
issues were actively debated in the 111th Congress during the food safety debate leading up to
passage of the FSMA.
Some in Congress also may continue to push for additional policy reforms either to existing FDA
or USDA food safety laws to address other perceived concerns regarding the safety of the U.S.
food supply, including resources and regulatory tools to adequately combat foodborne illness, as
well as coordination and organization among federal agencies.

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Contents
Background ................................................................................................................................ 1
Food Safety Incidents............................................................................................................ 2
Existing Food Safety Legal and Regulatory Landscape.......................................................... 4
FDA Food Safety Modernization Act (P.L. 111-353).................................................................... 5
Key Issues for the 112th Congress................................................................................................ 6
Oversight and Implementation of the New Law..................................................................... 6
Funding the New Law........................................................................................................... 7
The Next Omnibus Farm Bill ................................................................................................ 8
Meat and Poultry Inspection.................................................................................................. 9
Antibiotic Use in Animal Agriculture .................................................................................. 10
Seafood and Fisheries Products ........................................................................................... 10
Criminal Penalties and Enforcement.................................................................................... 11
Bisphenol A (BPA).............................................................................................................. 11
Dietary Supplements ........................................................................................................... 12
Agricultural Biotechnology ................................................................................................. 12
Single Food Agency ............................................................................................................ 13

Tables
Table 1. Number of Foodborne Illnesses, Hospitalizations, and Deaths ........................................ 3

Contacts
Author Contact Information ...................................................................................................... 13

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he 111th Congress passed comprehensive food safety legislation in December 2010 (FDA
Food Safety Modernization Act (FSMA), P.L. 111-353). The FSMA is focused on foods
T regulated by the Food and Drug Administration (FDA), within the U.S. Department of
Health and Human Services (HHS), and is the largest expansion of FDA’s food safety authorities
since the 1930s. Among its key elements, the new law requires FDA to establish comprehensive,
prevention-based controls across the food supply; specifies how often FDA should inspect food
producers; provides FDA with new tools to ensure that food imports meet U.S. food safety
standards; gives FDA mandatory recall authority for food products; and directs FDA to improve
training of state, local, territorial, and tribal food safety officials.
The 112th Congress may provide oversight over how the law is implemented, but it may also
continue to consider additional changes to other food safety laws and policies that have been
actively debated in Congress.
Background
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. However, critics view this
system as lacking the organization, regulatory tools, and resources to adequately combat
foodborne illness. The Centers for Disease Control and Prevention (CDC) reports that each year
an estimated one in six Americans—a total of 48 million people—become sick from
contaminated food.1 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.2
The Obama Administration has taken certain actions to address food safety concerns. In 2009,
President Obama established a Food Safety Working Group (FSWG) of cabinet secretaries and
senior officials to provide advice on how to upgrade U.S. food safety laws, foster coordination
throughout government, and ensure that food safety laws are effective and enforced. In 2010, as
part of the FSWG’s annual progress report, the Administration announced that it had taken steps
to reduce the prevalence of certain food risks and implemented new food safety standards, among
other actions.3 The HHS released a draft of its plans regarding specific food safety goals, setting
percentage reduction goals for major food contaminants as well as targeted reductions in the
number of cases each year by 2020.4
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.5 Also at issue are whether federal food safety laws have kept pace with the

1 U.S. Department of Health and Human Services, Centers for Disease Control and Prevention (CDC), “Estimates of
Foodborne Illness in the United States,” December 2010, http://www.cdc.gov/foodborneburden/2011-foodborne-
estimates.html.
2 GAO, High Risk Series: An Update (GAO-09-271), January 2009.
3 FSWG, “Food Safety Working Group: Progress at 1 Year,” July 9, 2010, http://www.foodsafetyworkinggroup.gov/.
4 FDA, “Strategic Priorities 2011–2015: Responding to the Public Health Challenges of the 21st Century,” Draft,
September 29, 2010 (part of the broader Healthy People 2020 initiative at http://www.healthypeople.gov/2020),
http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Reports/StrategicAction Plan/UCM226907.pdf.
5 Roughly two-thirds of the $1 trillion is for domestically produced farm foods; imports and seafood account for the
balance. USDA, Economic Research Service (ERS) data, at http://www.ers.usda.gov/Browse/FoodSector/.
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significant changes that have occurred in the food production, processing, and marketing sectors;
whether food safety agencies have the resources, authority, and structural organization to
safeguard the public; and whether they use resources effectively.
Food Safety Incidents
Food safety incidents frequently heighten public and media scrutiny of the U.S. food safety
system.6 These outbreaks have raised questions about the adequacy of FDA’s and FSIS’s
safeguards for ensuring the safety of both domestically produced foods and imported foods.
These include major incidents involving FDA-regulated food such as the 2010-2011 multistate
recall of Salmonella-contaminated sprouts that sickened more than 100 people in 16 states and
Washington, DC, linked to an Illinois organic farm.7 This followed a nationwide recall of more
than 500 million eggs in the summer of 2010, associated with increased cases of infection with
Salmonella Enteritidis, a strain commonly associated with shell eggs. Another multi-state
outbreak of Salmonella Typhimurium in late 2008 and early 2009 was linked to an institutional
brand of peanut butter and other peanut-based ingredients from a single company. That 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. Other widespread illness outbreaks
have been linked to the consumption of bagged fresh spinach grown in California that carried E.
coli O157:H7 and, later, to Mexican produce that carried Salmonella. There have also been large
recalls of FSIS-regulated meat and poultry products due to findings of E. coli O157:H7, Listeria,
and other problems.
CDC reported that in 2007 there were 18 multistate foodborne illness outbreaks.8 Of these, 10
were attributed to Salmonella, six to E. coli O157:H7, one to Clostridium botulinum, and one to
norovirus. Among the foods associated with multistate Salmonella outbreaks were commercially
processed frozen pot pies (401 illnesses, three deaths), commercially processed vegetable snacks
(87 illnesses), eggs (81 illnesses), spinach/lettuce (76 illnesses), beefsteak tomatoes (65 illnesses),
raw tuna (44 illnesses), ground beef (43 illnesses), cheese (20 illnesses), alfalfa sprouts (15
illnesses), and raw fresh basil (11 illnesses). Most of the six multistate outbreaks of E. coli
O157:H7 infection were for ground beef (117 illnesses), with one due to commercially processed
frozen pepperoni pizzas (27 illnesses). Clostridium botulinum toxin resulted in eight illnesses
from commercially canned hotdog chili sauce. The one multistate outbreak caused by norovirus
was associated with raw oysters (40 illnesses).
CDC reports that each year an estimated total of 48 million people become sick from
contaminated food.9 Of these an estimated 128,000 cases require hospitalization and 3,000 cases

6 Foodborne outbreaks and their implications for the nation’s food safety system are discussed in more depth in CRS
Report R40916, Food Safety: Foodborne Illness and Selected Recalls of FDA-Regulated Foods, by Sarah A. Lister and
Geoffrey S. Becker, and CRS Report RL34313, The USDA’s Authority to Recall Meat and Poultry Products.
7 FDA press release, “FDA: Don’t Eat Certain Lots of Tiny Greens Brand Alfalfa Sprouts or Spicy Sprouts,” December
27, 2010,; and M. Rothschild, “Sprouts Outbreak Toll Now at 112 in 18 States,” Food Safety News, January 7, 2011.
8 CDC, “Surveillance for Foodborne Disease Outbreaks—United States, 2007,” Morbidity and Mortality Weekly
Report (MMWR), Vol. 59, No. 31, August 13, 2010, http://www.cdc.gov/mmwr/pdf/wk/mm5931.pdf. Also based on
summary findings posted in Suzanne Schreck, “CDC Releases 2007 Foodborne Illness Numbers,” Food Safety News,
August 13, 2010. 2007 is the most year that data are available.
9 CDC, “Estimates of Foodborne Illness in the United States,” December 2010.
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result in death. These estimates are for two major groups of foodborne illnesses: (1) known
foodborne pathogens (31 pathogens, many of them tracked by public health systems that track
diseases and outbreaks); and (2) “unspecified agents” where insufficient data does not allow for
the estimation of agent-specific burden.10 Foodborne illnesses from known pathogens account for
about one-fifth of CDC’s estimate of the total number of foodborne illnesses per year and about
40% of the estimated number of illnesses resulting in either hospitalizations or death (Table 1).
The remaining number of illnesses, hospitalizations, and deaths are attributable to foodborne
illness from “unspecified agents.”
Table 1. Number of Foodborne Illnesses, Hospitalizations, and Deaths
United States, Estimated Annual
Estimated annual
Estimated annual
number of
Estimated annual
number of illnesses
%
hospitalizations
%
number of deaths
%
Foodborne
Agents
(90% credible interval)a
9.4 million 20
55,961 44
1,351 44
31 Known
Pathogens
(6.6–12.7 million)
(39,534–75,741)
(712–2,268)
38.4 million 80
71,878 56
1,686 56
Unspecified
Agents
(19.8–61.2 million)
(9,924–157,340)
(369–3,338)
47.8 million 10
127,839 100
3,037 100
Total
(28.7–71.1 million) (62,529–215,562)
(1,492–4,983)
Source: CDC, “Estimates of Foodborne Illness in the United States,” December 2010, http://www.cdc.gov/
foodborneburden/2011-foodborne-estimates.html; also http://www.cdc.gov/foodborneburden/PDFs/
FACTSHEET_A_FINDINGS.pdf (Table 1, Estimated annual number of domestically acquired, foodborne illnesses,
hospitalizations, and deaths due to 31 pathogens and unspecified agents transmitted through food, United States).
a. The credible interval (or Bayesian probability interval) refers to the point estimates obtained by CDC using
posterior distributions to generate a posterior mean and an upper and lower 5% limits for a 90% credible
interval (such that the estimated posterior probability is that 90% of that population is between the
interval). See E. Scallan, R. M. Hoekstra, F. J. Angulo, R. V. Tauxe, M. Widdowson, S. L. Roy, J. L. Jones, and
P. M. Griffin, “Foodborne Illness Acquired in the United States—Major Pathogens,” Emerging Infectious
Diseases, Vol. 17, No. 1, January 2011, http://www.cdc.gov/eid/content/17/1/pdfs/7.pdf.
The top five pathogens contributing to foodborne illnesses are norovirus (58% of illnesses),
Salmonella, nontyphoidal (11%), Clostridium perfringens (10%), Campylobacter spp. (9%), and
Staphylococcus aureus (3%). The top five pathogens contributing to foodborne illnesses resulting
in hospitalization are Salmonella, nontyphoidal (35% of illnesses), norovirus (26%),
Campylobacter spp. (15%), Toxoplasma gondii (8%), and E.coli (STEC11) O157 (4%). The top
five pathogens contributing to foodborne illnesses resulting in death are Salmonella, nontyphoidal
(28% of deaths), Toxoplasma gondii (24%), Listeria monocytogenes (19%), norovirus (11%), and
Campylobacter spp. (6%).12

10 Ibid; also http://www.cdc.gov/foodborneburden/PDFs/FACTSHEET_A_FINDINGS.pdf.
11 Shiga toxin-producing Escherichia coli (STEC) is a type of enterohemorrhagic bacteria that can cause illness ranging
from mild intestinal disease to severe kidney complications.
12 CDC, “Estimates of Foodborne Illness in the United States,” December 2010.
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Throughout the 110th and 111th Congress, hearings and government reports cited problems with
food imports from China and other countries, at a time when Americans receive an increasing
portion of their food supply from foreign sources. That prompted consideration of additional
actions—beyond the infrequent sampling and testing now done at the border to detect problems
among the millions of food import shipments annually—that FDA could take to ensure the safety
of foreign foods. USDA’s FSIS, for example, allows foreign meat and poultry imports to enter the
United States only from countries that it has determined have equivalent safety standards. This
prompted consideration about whether FDA should adopt a similar approach for the significantly
larger portion of the food supply it regulates, or at least for certain higher-risk foods. Other
related issues included how such risks should be determined; the extent to which private
importers should be responsible for assuring food safety; and the best approach for government to
certify the adequacy of importer food safety efforts.
Existing Food Safety Legal and Regulatory Landscape
Numerous federal, state, and local agencies share responsibilities for regulating the safety of the
U.S. food supply.13 Federal responsibility for food safety rests primarily with the FDA and the
USDA. FDA at the U.S. Department of Health and Human Services (HHS) is responsible for
ensuring that all domestic and imported food products—except for most meats and poultry—are
safe, nutritious, wholesome, and accurately labeled. FDA also has oversight of all seafood, fish,
and shellfish products. USDA’s Food Safety and Inspection Service (FSIS) regulates most meat
and poultry and some egg products. GAO has identified 15 federal agencies collectively
administering at least 30 laws related to food safety. State and local food safety authorities
collaborate with federal agencies for inspection and other food safety functions, and they regulate
retail food establishments. This organizational complexity, and trends in U.S. food markets—for
example, increasing imports as a share of U.S. food consumption and increasing consumption of
fresh, often unprocessed, foods—pose ongoing challenges to ensuring food safety.
The division of food safety responsibility between FDA and USDA is rooted in the early history
of U.S. food regulation. Congress created separate statutory frameworks when it enacted, in 1906,
both the Pure Food and Drugs Act and the Meat Inspection Act. The former addressed the
widespread marketing of intentionally adulterated foods, and its implementation was assigned to
USDA’s Bureau of Chemistry. The latter law addressed unsafe and unsanitary conditions in meat
packing plants, and implementation was assigned to the USDA’s Bureau of Animal Industry. This
bifurcated system has been perpetuated and split further into additional food safety activities
under additional agencies (for example, the Environmental Protection Agency, the National
Marine Fisheries Service, and others) by a succession of statutes and executive directives. The
separation of the two major food safety agencies was further reinforced when, in 1940, the
President moved responsibilities for safe foods and drugs, other than meat and poultry, from
USDA to the progenitor of HHS, the Federal Security Agency. Meat inspection remained in
USDA. There has been discussion over time regarding whether this dispersal of food safety
responsibilities has been problematic, or whether a reorganization would divert time and attention
from other fundamental problems in the system.14

13 For other background information, see CRS Report RS22600, The Federal Food Safety System: A Primer and CRS
Report RS22946, Food and Drug Administration (FDA): Overview and Issues.
14 For a discussion of the history of federal food safety organization and of efforts to change it, see Merrill, Richard A.
and Jeffrey K. Francer, “Organizing Federal Food Safety Regulation,” Seton Hall Law Review, vol. 31:61, 2000. See
(continued...)
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The majority of both total funding and total staffing, however, is with FSIS at USDA, and FDA,
which regulates virtually all other foods. FSIS’s FY2010 budget was $1.019 billion in
appropriated funds plus another approximately $130 million in industry-paid user fees.15 FDA’s
budget for foods was $784.1 million in FY2010,16 virtually all of it appropriated with limited
authorized user fees.17 Thus, FSIS had approximately 60% of the two agencies’ combined food
safety budget, and FDA had the other approximately 40%. This discrepancy in funding exists
although FSIS is responsible for between 10% and 20% of the U.S. food supply, while FDA is
responsible for the remainder.18 Staffing levels also vary considerably among the two agencies:
FSIS staff numbers around 9,400, while FDA staff working on food-related activities numbers
2,800 full-time employees.
FDA Food Safety Modernization Act (P.L. 111-353)
The FDA Food Safety Modernization Act (FSMA, P.L. 111-353) focused on FDA-regulated foods
and amended FDA’s existing structure and authorities, in particular the FFDCA (21 U.S.C. §§ 301
et seq.). FSMA does not directly address meat and poultry products under the jurisdiction of
USDA. Among its many provisions, FSMA expands FDA’s authority to conduct a mandatory
recall of contaminated food products; enhancing surveillance systems to investigate foodborne
illness outbreaks; establishing and enforcing new preventive controls and food safety plans at
some food processing facilities and farms; enhancing FDA’s traceability capacity within the
nation’s food distribution channels; increasing inspection frequencies of high-risk food facilities
(both domestic and foreign facilities); and expanding FDA’s authority and oversight capabilities
of foreign companies that supply food imports to the United States.
FDA has identified five key elements to the new law:19
• Preventive controls—For the first time, FDA has a legislative mandate to
require comprehensive, prevention-based controls across the food supply.
• Inspection and Compliance—The FSMA recognizes that inspection is an
important means of holding industry accountable for its responsibility to produce
safe food. The law specifies how often FDA should inspect food producers. FDA

(...continued)
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.
15 CRS Report R41475, Agriculture and Related Agencies: FY2011 Appropriations. Fees are from the explanatory
notes of the President’s Budget request: http://www.obpa.usda.gov/explan_notes.html. FSIS collects user fees to cover
overtime and other services, including inspection and laboratory costs, and also trust fund activities.
16 FDA data are from the President’s Budget Request “All Purpose Table—Total Program Level.”
17 CRS Report R41288, Food and Drug Administration FY2011 Budget and Appropriations, by Susan Thaul. User fees
related to foods have been proposed in legislation and in budget requests over time. The FY2011 President’s budget
request has proposed user fees for reinspection, export certification, inspection and registration.
18 The 20% estimate is based on information reported by the Government Accountability Office (GAO) in “Revamping
Oversight of Food Safety,” prepared for the 2009 Congressional and Presidential Transition, and appear to represent
proportions of total spending for food consumed at home. The 10% estimate is based on data from USDA’s Economic
Research Service (ERS) on U.S. per capita food consumption at http://www.ers.usda.gov/data/foodconsumption/.
19 FDA, “Questions and Answers on the Food Safety Modernization Act,” http://www.fda.gov/NewsEvents/
PublicHealthFocus/ucm238506.htm.
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has said that it is “committed to applying its inspection resources in a risk-based
manner and adopting innovative inspection approaches.”
• Imported Food Safety—The FSMA provides FDA with new tools to ensure that
food imports meet U.S. food safety standards. 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 will have mandatory recall authority for all
food products. 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.”
• Enhanced Partnerships—The 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—U.S. federal, state, local,
territorial, tribal, and foreign—to achieve its public health goals.
The FSMA also authorized additional appropriations and staff for FDA’s future food safety
activities. The Congressional Budget Office (CBO) estimated that implementing the newly
enacted law could increase net federal spending subject to appropriation by about $1.4 billion
over a five-year period (FY2011-FY2015).20 The enacted bill authorizes an increase in FDA staff,
reaching up to 5,000 in FY2014.
For more detailed information, see CRS Report R40443, The FDA Food Safety Modernization
Act (P.L. 111-53).
Key Issues for the 112th Congress
The 112th Congress may provide oversight and scrutiny of food safety changes enacted in the
previous Congress as they are implemented. In addition, the 112th Congress also may continue to
consider changes to other food safety laws and policies that continue to be actively debated in
Congress. Among these are food safety initiatives covering meat, poultry, and seafood products;
legislation intended to curtail the non-medical use of antibiotics in animal feeds and to ban the
use of certain plastic components commonly used in food containers; food labeling; and the use
of plant and animal biotechnology, among other issues.
Oversight and Implementation of the New Law
FSMA is the largest expansion of FDA’s food safety authorities since the 1930s. It includes
provisions that expand FDA’s authority to conduct a mandatory recall of contaminated food
products; enhance surveillance systems to investigate foodborne illness outbreaks; establish and
enforce new preventive controls and food safety plans at some food processing facilities and

20 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.
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farms; enhance FDA’s traceability capacity within the nation’s food distribution channels;
increase inspection frequencies of high-risk food facilities (both domestic and foreign facilities);
and expand FDA’s authority and oversight capabilities of foreign companies that supply food
imports to the United States. The 112th Congress may actively oversee implementation of the law,
including associated rulemaking. Implementation of a number of provisions will require
coordination with other federal agencies such as USDA and the Department of Homeland
Security (DHS).
Some in Congress may actively follow the implementation of certain exclusions in the new food
safety law intended to mitigate the economic effects on small, organic, direct-to-market, and
sustainable farming operations.21 These provisions will exempt from the new federal regulations
some small-sized farms and food processors that sell directly to consumers (FSMA, sections 103
and 105). These exemptions require additional rulemaking by FDA to determine what constitutes
a “small” and “very small” business under the new law. Some public health groups may remain
vigilant of how these exemptions are implemented, particularly for growers and processors of
certain perceived “high-risk” foods (to be determined by the HHS Secretary), although these
operations would be subject to oversight by state and local authorities and their exemption can be
withdrawn by the FDA in the event of a foodborne illness. Some agribusiness groups also remain
opposed to these exemptions because of broader industry concerns about the need to preserve
consumer confidence in the safety of all marketed produce; another industry concern is whether
small foreign producers might also be exempt, if small U.S. producers are exempt (given
prevailing U.S. equivalency standards).
Funding the New Law
Among the many provisions of FSMA is the expansion of FDA’s authority to increase inspection
of domestic and foreign food facilities, to increase surveillance of foodborne illness and outbreak
response, to conduct mandatory recall of contaminated foods, and to enforce new requirements at
food facilities and produce operations. Given the current budgetary climate, funding to undertake
many of these new or enhanced federal activities is uncertain. 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. These funding decisions rest with the House
and Senate Appropriations Committees, which annually fund FDA’s activities in the Agriculture
appropriations bill. The Administration requested additional funds for FDA in its budget request
to fund additional food safety activities, but Congress has yet to act on a full-year appropriation to
fund FDA for FY2011.22 FDA and the activities of the new food safety law will be competing for
a limited amount of discretionary funds along with the other agencies funded in the annual
appropriations bill. If sufficient funds are not forthcoming in the annual appropriations bill, then
implementation of the food safety law may be difficult or delayed.
CBO estimated that implementing the newly enacted law could increase net federal spending
subject to appropriation by about $1.4 billion over a five-year period (FY2011-FY2015);
collections from possible revenue and direct spending increases from new criminal penalties
would be “insignificant, yielding a negligible net impact in each year.”23 FDA’s annual budget for

21 For more information, see CRS Report RL34612, Food Safety on the Farm.
22 See CRS Report R41475, Agriculture and Related Agencies: FY2011 Appropriations.
23 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,
(continued...)
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its human foods program was $784 million for FY2010. Other industry experts have stated that
FDA needs substantially more resources to effectively monitor the U.S. food supply.24 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.25
Given existing budgetary constraints, some have questioned whether the 112th Congress will fund
the increased staff and regulatory activities authorized by the bill. FDA Commissioner Margaret
Hamburg has stated that there are some steps the agency can take without the increased funding
and said she remains “optimistic” that FDA will be able to move forward and implement the
bill.26 The expanded federal authorities in the new food safety bill—covering increased
inspections, surveillance and enforcement—would likely require an increase in FDA field staff.
The newly enacted law states a “goal of not fewer than … 5,000 staff members in fiscal year
2014” (FSMA, section 401), an increase above estimated current FDA field staff of about 2,800
FTEs (full-time equivalents) in 2010.
The new chairman of the appropriations subcommittee overseeing FDA’s and USDA’s budgets,
Representative Jack Kingston, has questioned the need for increased funding for FDA under the
newly enacted law, considering the current budgetary environment.27
The Next Omnibus Farm Bill
The 112th Congress could consider reauthorization of the 2008 farm bill (Food, Conservation, and
Energy Act of 2008, P.L. 110-246) because much of the current law expires in 2012.28 Although
many of the enhancements enacted in FSMA focused on FDA-regulated foods and programs, the
new law did include provisions that involve coordination with USDA and could have implications
for some farm bill programs. For example, FSMA requires that FDA coordinate with the
extension activities of USDA’s National Institute of Food and Agriculture (NIFA) in advising
producers and small processors of new food safety requirements through competitive training and
technical assistance grants (FSMA, section 209). The new law also creates a new program,
“National Food Safety Training, Education, Extension, Outreach and Technical Assistance
Program,” whereby the NIFA will award competitive grants to carry out the extension activities
under the new law. Funding for these programs is authorized to be appropriated through FY2015.
These new programs may be considered in the context of the next farm bill. Similarly, the new
food safety law also specifies that “in the case of production that is certified organic,” the food
safety requirements should not “conflict with or duplicate the requirements of the national
organic program” under the Organic Foods Production Act of 1990 (P.L. 101-624), which was last
amended by the 2008 farm bill.

(...continued)
2010,” August 12, 2010. Reflecting the August 2010 Senate amendment to S. 510.
24 Helena Bottemiller, “Acheson: FDA Needs $5 Billion for Food Safety,” Food Safety News, October 28, 2010.
25 Helena Bottemiller, “FDA’s Taylor: ‘We'll Hit the Ground Running’,” Food Safety News, January 28, 2011.
26 Helena Bottemiller, “Food Safety Bill Advocates Expect Funding Fight,” Food Safety News, January 4, 2011.
27 Helena Bottemiller, “FDA Food Safety Funding Still on Chopping Block,” Food Safety News, January 13, 2011.
28 For more information, see CRS Report RS22131, What Is the “Farm Bill”? and CRS Report RL34696, The 2008
Farm Bill: Major Provisions and Legislative Action.
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Alternatively, the next farm bill (possibly in 2012) could contain provisions in response to the
new food safety law. For example, the new food safety law requires new safety standards for
produce growers (FSMA, section 105), as well as new requirements that growers and food
facilities have food safety plans. During the farm bill debate, the agricultural community may
want USDA to deliver additional training programs, technical assistance, or research programs for
produce growers who are affected by the law. If new USDA discretionary programs are developed
in the farm bill, they might also face the same funding uncertainty as FDA for the new food safety
law. If authorizers choose, such programs could be funded in the farm bill with mandatory
funding. However, competition for limited mandatory funds is expected to be fierce in the farm
bill among existing mandatory programs.
Meat and Poultry Inspection
The food safety changes enacted in the 111th Congress focused on FDA-regulated foods and did
not address foods under the jurisdiction of USDA. USDA’s FSIS regulates most meat and poultry
and some egg products. Some in Congress have long claimed that once FDA’s food safety laws
were amended and updated, it would be expected that Congress would next turn to amending
laws and regulations governing USDA’s meat and poultry products.29 Food safety incidents and
concerns regarding USDA-regulated meat and poultry products are similarly well documented. In
addition, a series of bills were introduced and debated in the 111th Congress regarding the safety
of meat and poultry products, which may be re-introduced in the 112th Congress. Among food
safety issues regarding meat and poultry products are the safety of the meat and poultry being
supplied to school meals programs; FSIS protocols for handling food recalls and related
enforcement issues; improved meat traceability capabilities and animal identification systems;
FSIS budgetary and staffing constraints; animal diseases and other related sanitary issues; and
humane slaughter and animal welfare concerns.30
A related issue involves allowing state-inspected meat and poultry products into interstate
commerce. Federal law long prohibited state-inspected meat and poultry plants from shipping
their products across state lines, a ban that many states and small plants sought to overturn. In the
110th Congress, the 2008 farm bill (Food, Conservation, and Energy Act of 2008, P.L. 110-246,
section 11015) amended current meat and poultry laws to authorize a new opt-in program for
state-inspected plants.31 This program was intended to supplement rather than replace the existing
federal-state cooperative inspection programs, and reportedly was developed as a compromise in
the 2008 farm bill. Some proponents of ending the interstate ban on state-inspected meat
contended that the new language is overly restrictive, while those who supported the change
countered that it provides appropriate safeguards. This issue could get renewed interest if
Congress decides to actively review existing meat and poultry food safety laws at USDA; also,
issues may arise as USDA finalizes and implements rules for an opt-in program for state-
inspected plants.

29 See, for example, Statement by Representative Rosa DeLauro, Congressional Record, December 21, 2010, p. H8887.
30 For more information, see CRS Report RL32922, Meat and Poultry Inspection: Background and Selected Issues.
31 See CRS Report RL34202, State-Inspected Meat and Poultry: Issues for Congress.
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Antibiotic Use in Animal Agriculture
Public health experts have expressed concern about growing resistance of infectious diseases to
antibiotics, and about patients whose infections are difficult or impossible to treat as a result.32
Antibiotic resistance has been linked to a number of causes, including the overuse of antibiotics
by medical professionals, and the use of antibiotics for non-medical purposes in food animals.
(Antibiotics are added to feed for some types of food-producing animals not only to treat and
prevent diseases, but also to improve growth and efficient use of feed rations.) Some argue that
non-medical uses in food animals should be limited to drugs that are not useful in human
medicine. Others oppose this approach, arguing that animal production may not be commercially
viable without the drugs’ routine use, and that the linkage between such use and antimicrobial
resistance in humans lacks a strong scientific basis.
In the past several Congresses, bills have been introduced that would curtail the non-medical use
of antibiotics in animal feeds. In the 111th Congress, these bills included the Preservation of
Antibiotics for Medical Treatment Act of 2009 (PAMTA) introduced in the House and Senate by
Representative Slaughter (H.R. 1549) and by Senator Reid (S. 619), respectively. These bills did
not advance, and might be offered again in the 112th Congress.
Seafood and Fisheries Products
Many food safety changes enacted in FSMA did not specifically address seafood and fisheries
products.33 Domestic and imported fish and shellfish are already regulated under a system of risk
prevention controls known as HACCP (for “Hazard Analysis and Critical Control Points”).
However, FSMA contains various provisions that could affect domestic and imported seafood
products and may generate congressional oversight. These include interagency agreements to
improve seafood safety by examining and testing seafood, coordinating inspections, standardizing
data, modifying existing processes, sharing enforcement and compliance information, and
conducting joint training and outreach (FSMA, section 201); requirements for guidance related to
post harvest processing of raw oysters (FSMA, section 114); and inspections of foreign
processing facilities by the Secretary of Commerce to assess practices and processes used in
connection with seafood production (FSMA, section 306). In addition, a number of seafood safety
issues were considered by the 111th Congress and may be of continued interest to the 112th
Congress. These issues include regulation of Gulf oyster fisheries, catfish inspection, and the
safety of Gulf of Mexico seafood following the 2010 oil spill.
In the wake of the Gulf of Mexico oil spill, large areas of federal and state waters were closed to
fishing as a precautionary measure to ensure the safety of seafood.34 Crude oil contains a mixture
of chemicals including polycyclic aromatic hydrocarbons (PAHs) that may accumulate in the
tissues of marine organisms. Petroleum products may also taint seafood with an oily smell and
taste. FDA considers tainted fish to be adulterated and does not permit the sale of adulterated
foods.35 For Gulf waters that have re-opened, sensory analyses have found no detectable oil or

32 For more information see CRS Report R40739, Antibiotic Use in Agriculture: Background and Legislation and CRS
Report R41047, Potential Trade Implications of Restrictions on Antimicrobial Use in Animal Production.
33 For more information see CRS Report RS22797, Seafood Safety: Background and Issues.
34 For more information contact Harry Upton at 7-2264.
35 21 U.S.C. § 331 and 21 U.S.C. § 342(a).
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dispersant odors or flavors, and results of chemical analyses have been well below levels of
concern.36 Some have criticized these efforts because they believe seafood sampling coverage is
insufficient, levels of concern should have considered additional factors, and the list of toxic
substances being tested is too narrow.37 Nearly all Gulf federal waters except for 1,041 square
miles immediately surrounding the well-head, and all state waters except for some areas in
Louisiana, have been reopened to commercial and recreational fishing.38
Criminal Penalties and Enforcement
The food safety changes enacted in FSMA did not substantially alter the criminal penalties
provisions within existing FDA laws. However, such provisions were actively considered as part
of the broader food safety debate. For example, the House-passed food safety bill (H.R. 2749,
111th Congress) would have amended the penalties provisions of FFDCA to provide for fines and
for a maximum prison sentence if any person knowingly engaged in certain prohibited acts with
respect to food that is misbranded or adulterated. A similar provision also was debated as part of
the Senate food safety bill, but not included in the Senate version of the bill. A separate Senate
bill, introduced by Senator Patrick Leahy (Food Safety Accountability Act of 2010, S. 3767) and
approved and reported out of the Senate Judiciary Committee, also would have amended the
penalty provisions of FFDCA to provide for fines and a maximum prison sentence for certain
violations. Although these provisions ultimately were not included in the enacted food safety
legislation, some may continue to be concerned about the need to modify existing laws to institute
stricter criminal fines and penalties as part of the U.S. food safety system. Such legislation might
be re-introduced and debated again in the 112th Congress.
Bisphenol A (BPA)
The food safety changes enacted in the 111th Congress did not alter existing requirements
regarding Bisphenol A (BPA), a component of certain plastics that is commonly used in food
containers, such as plastic bottles or metal can liners.39 Food containers made with BPA are
regulated by the FDA. BPA exposure has been linked to certain developmental problems in
animals, and proposals to reduce or eliminate the amount of the chemical in food containers were
actively considered as part of the food safety debate in the 111th Congress. For example, the
House-passed food safety bill would have required FDA to determine whether there was “a
reasonable certainty of no harm for infants, young children, pregnant women, and adults” for
approved uses of polycarbonate plastic and epoxy resin made with BPA in food and beverage
containers, among other provisions. A similar provision was debated as part of the Senate version
of the bill, and it was thought by some to be the reason that earlier Senate passage of the food
safety legislation was delayed.40 The Senate provision introduced by Senator Dianne Feinstein,

36 National Oceanic and Atmospheric Administration, “NOAA Reopens More Than 8,000 square miles of the Gulf of
Mexico to Fishing,” press release, November 15, 2010, http://www.noaanews.noaa.gov/stories2010/
20101115_reopening.html.
37 Bob Marshall, “Safety of Gulf Seafood Debated 8 Months After BP Oil Spill,” The Times-Picayune, December 19,
2010, http://www.nola.com/news/gulf-oil-spill/index.ssf/2010/12/safety_of_gulf_seafood.html.
38 For the FDA’s oil spill website see, http://www.fda.gov/Food/FoodSafety/Product-SpecificInformation/Seafood/
ucm210970.htm and for NOAA’s website see, http://sero.nmfs.noaa.gov/deepwater_Horizon_oil _spill.htm.
39 See CRS Report RS22869, Bisphenol A (BPA) in Plastics and Possible Human Health Effects.
40 See, for example, Julian Pecquet, “Democrats quarrel over food safety legislation,” The Hill, July 19, 2010.
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Ban Poisonous Additives Act of 2009 (S. 593, 111th Congress), would have banned BPA in all
FDA-regulated food containers. These proposals were not enacted, and there may be continued
interest in BPA regulation in the 112th Congress.
Dietary Supplements
The provisions of FSMA apply to most foods, including dietary supplements. FSMA includes two
provisions specifically focused on supplements (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, the agency determines the information to be inadequate because the
ingredient contains an anabolic steroid or an analogue of one. Following notification, DEA can
take action on the dietary ingredient as a controlled substance. The second provision requires that
FDA publish guidelines, within 180 days of enactment, to clarify the definition of a new dietary
ingredient and how a product so categorized is to be evaluated for safety. During the food safety
debate, several other provisions were considered that would have addressed supplements issues,
including product safety, increasing penalties for unsafe products, mandatory reporting for all
adverse effects, and expanding allowable health claims. Such provisions were not included in
FSMA, but could be addressed again in the 112th Congress.
Agricultural Biotechnology
Genetically engineered (GE, sometimes called genetically modified, or GM) crop varieties first
became commercially available in the mid-1990s.41 Since then U.S. soybean, cotton, and corn
farmers have rapidly adopted them to reduce production costs and raise crop yields. A number of
animal biotechnologies (including cloning) also are becoming available. Some Members of
Congress, particularly from agricultural areas, generally favor the adoption of such technologies,
along with publicly supported research and other activities aimed at gaining their acceptance in
foreign and domestic markets. Others question the food safety impacts of GE crops and animals,
and whether the current U.S. regulatory framework, which is based primarily upon statutory
authorities enacted before the rise of agricultural biotechnology, is still adequate.
In recent years, the introduction and pending efforts to deregulate several new genetically
engineered crops (e.g., alfalfa, sugar beets), and subsequent legal challenges to that introduction
and deregulation, have raised important issues regarding the effectiveness of the USDA’s
environmental review process, conducted through the agency’s Animal and Plant Health
Inspection Service (APHIS). Concern about increased herbicide resistant weeds associated with
the widespread use of genetically engineered crop varieties was also the subject of hearings in the
111th Congress. Other concerns involve the possibility of cross-contamination by GE crops of
other traditional crops and organically grown crops.42 FDA is also nearing completion of its
review to approve a genetically engineered salmon for human consumption. Labeling issues have
also been debated. Given these concerns and upcoming USDA regulations, Congress may closely
monitor the situation.

41 For more information see CRS Report RL32809, Agricultural Biotechnology: Background and Recent Issues and
CRS Report RL33334, Biotechnology in Animal Agriculture: Status and Current Issues
42 See, for example, Organic Trade Association (OTA) press release, “OTA Deeply Disappointed with Failure to
Protect Farmer and Consumer Choice,” January 27, 2011.
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Single Food Agency
Some in Congress may continue to push for additional reforms to the nation’s food safety system,
particularly with respect to coordination and organization among federal agencies. Efforts to
establish a single federal food safety agency were introduced and debated in the 105th and each
subsequent Congress. Although the idea has the support of the Government Accountability
Office, it also has its detractors. While some see consolidation as an opportunity for improvement
in the efficiency and effectiveness of food safety regulation, others worry that it could
unnecessarily compromise day-to-day food safety efforts. The food safety changes enacted in the
111th Congress did not alter the existing food safety jurisdiction between FDA and USDA, so the
issue may remain of interest to the Congress.

Author Contact Information

Renée Johnson

Specialist in Agricultural Policy
rjohnson@crs.loc.gov, 7-9588


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