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Food Safety on the Farm: Federal Programs
and Selected Proposals

Geoffrey S. Becker
Specialist in Agricultural Policy
April 21, 2010
Congressional Research Service
7-5700
www.crs.gov
RL34612
CRS Report for Congress
P
repared for Members and Committees of Congress
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Food Safety on the Farm: Federal Programs and Selected Proposals

Summary
Foodborne illness-causing bacteria on farms can enter the food supply unless preventive measures
are in place to reduce them, either prior to or after harvest. Also of potential risk to the food
supply are pesticide residues, animal drugs, and naturally occurring contaminants such as
aflatoxin.
Interest in on-farm practices was renewed after more than 1,300 persons in 43 states, the District
of Columbia, and Canada were found to be infected with the same unusual strain of bacteria
(Salmonella Saintpaul) in April-July 2008. Officials first suspected fresh tomatoes as the vehicle
and later expanded their concerns to fresh jalapeño and serrano peppers. By late July 2008,
genetic tests confirmed the pathogen on samples of a serrano pepper and irrigation water from a
farm in Tamaulipas, Mexico. Agricultural operations in the United States also have been
implicated in past outbreaks of foodborne illness.
Food safety experts agree that an effective, comprehensive food safety system should include
consideration of potential hazards at the farm level. However, opinions differ on the need for
more stringent, government-enforced safety standards for farms, as exist for processors and others
in the food chain. This question and others, such as the potential cost of new interventions to
producers, taxpayers, and consumers, are at issue as Congress debates food safety legislation.
The lead federal food safety agencies are the Food Safety and Inspection Service (FSIS) within
the U.S. Department of Agriculture (USDA), which regulates major species of meat and poultry
and some egg products, and the Food and Drug Administration (FDA) within the U.S.
Department of Health and Human Services (HHS), which regulates virtually all other foods.
Generally, these agencies’ regulatory oversight of foods begins after the farm gate, at slaughter
establishments and food handling and manufacturing facilities. However, various activities of
these and other federal agencies involved in assuring the safety of the food supply can, and do,
have an impact on how farms and ranches raise food commodities.
In the 111th Congress, comprehensive bills are progressing that could affect farmers and ranchers.
On June 10, 2009, a House Energy and Commerce Subcommittee marked up and approved H.R.
2749, which is based largely on provisions of an earlier version (H.R. 759) by the same sponsor.
H.R. 2749 would require the establishment of new standards for the production of some fruits,
vegetables, nuts, and fungi. Other provisions of H.R. 2749 that focus more broadly on food
safety, such as requiring a new food tracing system, and expanding authority for access to
records, also could impact on-farm practices. The full Energy and Commerce Committee further
amended and approved H.R. 2749 on June 17, 2009, and the full House passed the measure—
with additional changes made by the bill’s sponsors to address agricultural interests’ concerns—
on July 30, 2009.
The Senate Health, Education, Labor, and Pensions Committee marked up its food safety measure
(S. 510) on November 18, 2009, reporting it on December 18, 2009. Provisions in this bill also
would affect on-farm production, including but not limited to a section requiring produce safety
standards. As of this writing, interests representing smaller producers were seeking additional
changes in the bill to address their concerns about its impact on their operations; such changes, if
accepted by the bill’s managers, conceivably could be proposed as part of a so-called manager’s
amendment when the bill is considered on the Senate floor, where action was anticipated (but not
necessarily certain) in spring 2010.
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Food Safety on the Farm: Federal Programs and Selected Proposals

Contents
Introduction ................................................................................................................................ 1
Food Safety Hazards on the Farm................................................................................................ 2
Federal Food Safety Programs..................................................................................................... 2
Food and Drug Administration .............................................................................................. 2
Food Safety and Inspection Service....................................................................................... 6
Other Programs Affecting Producers ..................................................................................... 6
Regulation of Animal Drugs and Feeds ........................................................................... 6
Regulation of Pesticides .................................................................................................. 7
Animal Health Programs ................................................................................................. 7
Federal Marketing Programs ........................................................................................... 8
Leafy Greens Marketing Agreement ................................................................................ 8
Selected Proposals in Congress ................................................................................................... 9
Dingell Bill Overview (H.R. 2749)...................................................................................... 10
Farm Interest Concerns with H.R. 2749............................................................................... 10
Farm-Related Modifications in H.R. 2749 ........................................................................... 12
On-Farm Standards ....................................................................................................... 12
Facility Registration Requirements................................................................................ 12
Records Access ............................................................................................................. 13
Food Traceability .......................................................................................................... 13
Reportable Food Registry.............................................................................................. 13
Other Farm-Related Modifications ................................................................................ 13
Durbin Bill Overview (S. 510) ............................................................................................ 14
Treatment of Farms Under Other S. 510 Provisions ............................................................. 14
Inspection of Records.................................................................................................... 14
Registration of Food Facilities....................................................................................... 15
Hazard Analysis and Risk-Based Preventive Controls.................................................... 15
Targeting of Inspection Resources for Domestic Facilities, Foreign Facilities, and
Ports of Entry; Annual Report .................................................................................... 15
Enhancing Traceback and Record-Keeping ................................................................... 15
Concluding Observations on the Bills’ Provisions................................................................ 16

Contacts
Author Contact Information ...................................................................................................... 17

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Food Safety on the Farm: Federal Programs and Selected Proposals

Introduction
In recent years, major outbreaks of foodborne illnesses, product recalls, and reports about unsafe
food imports have caused some to question the adequacy of the U.S. food safety system.
Stakeholders appear to agree that an optimal system should encompass a comprehensive,
preventive approach to food safety, focusing on those foods and points in the food system that
pose the greatest public health risks, starting at the point of production—that is, on farms and
ranches.
Here, viewpoints diverge. Should farmers and ranchers be subject to mandatory safety standards,
enforced through certification of their practices, periodic inspections, and penalties for
noncompliance? Or, should public policy continue to encourage voluntary strategies for
producing safe foods on farms and ranches, through education, cooperation, and market-based
incentives? Historically, the federal and state governments have relied on the latter “carrot”
approach that, in the view of some critics, is no longer effective. Further complicating matters is
that consumers increasingly rely on distant, often foreign, sources of production for a significant
portion of their food.
It also could be argued that numerous laws and regulations already impose restrictions, both
direct and indirect, on producers of food commodities, which effectively meet food safety
objectives—and also involve significant compliance costs. These restrictions include
requirements on the use of animal drugs, feed additives, and pesticides. Voluntary and market-
based incentives also effectively regulate safety, it could be argued. For example, major food
marketing chains and food service providers generally set quality and safety standards that
suppliers must meet, which often extend back to the farm.
A number of high-profile illness outbreaks have placed on-farm practices under the policy
microscope. Examples include the following.
• After more than 1,300 persons in 43 states, the District of Columbia, and Canada
were found to be infected with the same unusual strain of bacteria (Salmonella
Saintpaul) in April-July 2008, officials first suspected fresh tomatoes as the
vehicle and later expanded their concerns to fresh jalapeño and serrano peppers.
By late July, genetic tests confirmed the pathogen on samples of a serrano pepper
and irrigation water from a farm in Tamaulipas, Mexico, the same strain found on
a pepper provided by one of the ill persons.
• In the fall of 2006, more than 200 confirmed illnesses and three deaths were
linked to the consumption of packaged spinach that apparently had been
contaminated by E. coli O157:H7 in California fields, possibly due to the
presence of wild pigs, the proximity of irrigation wells used to grow the produce,
or surface waterways exposed to feces from cattle and wildlife.
• Numerous recent recalls and illness outbreaks have been linked to E. coli
O157:H7 in raw or undercooked beef products. The bacteria is endemic in the
live U.S. cattle population and can become a greater hazard if measures are not
taken to control its spread on ranches and feedlots and in processing plants.
(Proper cooking kills E. coli O157:H7.)
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Food Safety Hazards on the Farm
Pathogens—bacteria, viruses and other biological hazards—are the leading cause of foodborne
illnesses. Pathogens are found in foods of all kinds, although those of animal origin, including
raw meat and poultry, eggs, unpasteurized milk, and seafood, are most likely to be contaminated.
Fruits and vegetables also are of growing concern, particularly because a considerable portion is
consumed raw. Often these pathogens are first acquired at the farm (or harvest) level; processing
and cooking does not always kill them.1
Also complicating an understanding of on-farm food safety is “the range of pathogens on the
farm and the range of organisms associated with each food product,” the American Society for
Microbiology report notes. Foodborne pathogens include the following. Viruses such as hepatitis
A often originate from human feces, which can contaminate produce either when handled by
infected humans or exposed to unsafe irrigation or washing water. Parasites such as
Cryptosporidium, Cyclospora, and Giardia can be acquired from human and other animal fecal
material directly or through water or soil; such waste can be generated by both domesticated and
wild animals. Bacteria including Salmonella enteritidis, E. coli O157, Campylobacter, Vibrio, and
Yersinia are ubiquitous and can proliferate on the farm; the degree to which they are a problem
depends on such variables as animal density and housing, feeding practices, water and wastewater
treatment and disposal methods, human handling practices, interactions between animals, and the
proximity of animals to crop-producing fields and orchards. Some hazards are naturally
occurring, such as aflatoxin, a fungus that can infect crops, including peanuts and grains.
Pre-harvest controls are only effective if additional safety problems are avoided further down the
food production and marketing chain. There is not always a clear relationship between food
safety measures taken—or not taken—prior to harvest, and their impacts on the incidence of
foodborne illnesses.
Also of potential risk to the food supply are numerous nonbiological contaminants. Fruits,
vegetables, and other crops can contain higher than acceptable levels of pesticides if they are
improperly applied prior to harvest to control weeds and kill insect pests, or after harvest to
control fungus, insects, or rodents during food storage. Foods of animal origin potentially can
contain excess residues of drugs administered to control or eliminate diseases or promote more
efficient growth.
Federal Food Safety Programs
Food and Drug Administration
The Food and Drug Administration (FDA) within the U.S. Department of Health and Human
Services (HHS) is responsible for ensuring that all domestic and imported foods—excepting

1 Sources include various background materials and reports from the U.S. Department of Health and Human Services
(HHS), Centers for Disease Control and Prevention (CDC); also, Isaacson, Richard E., and others, “Preharvest Food
Safety and Security,” a 2004 report by the American Society for Microbiology. Although these sources include
discussions of seafood-borne food safety risks, this CRS report focuses primarily on land-based agricultural operations.
See also CRS Report RS22797, Seafood Safety: Background and Issues, by Geoffrey S. Becker and Harold F. Upton.
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major species of meat and poultry and some egg products—are safe, wholesome, and accurately
labeled. FDA’s primary governing statutes are the Federal Food, Drug, and Cosmetic Act
(FFDCA) as amended (21 U.S.C. 301 et seq.) and the Public Health Service Act (PHSA) as
amended (42 U.S.C. 201 et seq.). FDA divides responsibilities for the safety of eggs with the U.S.
Department of Agriculture (USDA), under the Egg Products Inspection Act as amended (21
U.S.C. 1031 et seq.). FDA appears to have the authority to regulate at least some on-farm
activities, although it rarely does so.2
FDA has focused its oversight and enforcement activities on periodic inspections of food
processing and handling facilities, on sampling and testing foods for the presence of adulterants,
and on cooperation with firms seeking approval of specific food or feed additives or packages.
FDA has promulgated “current good manufacturing practice” (CGMP) requirements (21 C.F.R.
Part 110). Failure to comply with these requirements, which apply to manufacturing, packing, or
holding human food, can result in enforcement actions and penalties, including an FDA
declaration that a food is adulterated. Excluded from these requirements are establishments
engaged solely in harvesting, storing, or distributing raw agricultural commodities. FDA rules do
state that the agency “will issue special regulations if it is necessary to cover these excluded
operations.”3
The Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (P.L. 107-
188) added several new food-related provisions to the FFDCA. Notably, FFDCA § 414 now sets
forth record-keeping requirements and the circumstances for making these records available for
inspection by the Secretary of Health and Human Services (for practical purposes, by the
department’s Food and Drug Administration). Also, FFDCA § 415 requires food facilities to
register with the FDA. Both provisions exempt farms but do not define the term “farm.”
More specifically, FFDCA § 414 states, in part:
If the Secretary has a reasonable belief that an article of food is adulterated or presents a threat of
serious adverse health consequences or death to humans or animals, each person (excluding farms
and restaurants) who manufactures, processes, packs, distributes, receives, holds, or imports
such article
shall, at the request of an officer or employee duly designated by the [HHS]
Secretary, permit such officer or employee, upon presentation of appropriate credentials and with
a written notice to such person, at reasonable times and within reasonable limits and in a
reasonable manner, to have access to and copy all records related to such article that are needed to
assist the Secretary in determining whether the food is adulterated and presents a threat of serious
adverse health consequences or death to humans or animals. (emphasis added)
Other parts of FFDCA § 414 delineate the types of such records, and authorize the promulgation
of regulations on record-keeping requirements.
FFDCA § 415(a) requires that “any facility engaged in manufacturing, processing, packing, or
holding food for consumption in the United States be registered with the [HHS] Secretary,”

2 A more detailed legal analysis appears in CRS Report RS22939, FDA Authority to Regulate On-Farm Activity, by
Vanessa K. Burrows. FDA’s own arguments in support of its on-farm authority can be found in a proposed rule to
regulate egg production to control Salmonella enteritidis, at 69 Federal Register pp. 56842-45. See also CRS Report
RS22600, The Federal Food Safety System: A Primer.
3 21 C.F.R. 110.19(b). The FFDCA at 21 U.S.C. § 321(r) defines a “raw agricultural commodity” as “any food in its
raw or natural state, including all fruits that are washed, colored, or otherwise treated in their unpeeled natural form
prior to marketing.”
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among other language. FFDCA § 415(b) states (in part) that for purposes of this section, a facility
“includes 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” (emphasis
added).
As noted, neither § 414 nor § 415 provides a definition of “farm.” (The term also does not appear
to be defined elsewhere in the FFDCA.) However, FDA’s implementing regulations for these two
provisions of the bioterrorism act do provide more guidance on how farms are to be treated. A
portion of the regulations (at 21 CFR 1.226) on the facility registration requirements (i.e., of
FFDCA § 415) lists farms among the exempted entities, and (at 21 CFR 1.227) defines a farm as
a facility in one general physical location devoted to the growing and harvesting of crops, the
raising of animals (including seafood), or both. Washing, trimming of outer leaves, and cooling
produce are considered part of harvesting. The term “farm” includes: (1) Facilities that pack or
hold food, provided that all food used in such activities is grown, raised, or consumed on that
farm or another farm under the same ownership; and (2) Facilities that manufacture/process food,
provided that all food used in such activities is consumed on that farm or another farm under the
same ownership.
The FDA regulations implementing the record-keeping and access requirements of FFDCA § 414
also exempt farms (at 21 CFR 1.327), and (at 21 CFR 1.328) also define a farm as noted above.4
More generally in its exercise of FFDCA authority, FDA’s traditional approach has been not to
impose mandatory on-farm safety standards or inspections of agricultural facilities.5 Rather, the
agency has relied on farmers’ adoption of so-called good agricultural practices to reduce hazards
prior to harvest. Such practices are issued as FDA guidance, not regulations; they are advisory
and not legally enforceable responsibilities.6 The agency’s agricultural guidance documents7 have
focused on the safety of fresh fruit and vegetables in recent years, which are more likely to be
consumed in uncooked forms than are other regulated foods (cooking can kill many pathogens).
FDA’s recommendations cover, for example, the use and testing of water that will come in contact
with crops, proper application of animal manure, and sanitation for field workers.
FDA in recent years has sought to address recurring outbreaks of E. coli O157:H7 associated with
fresh and fresh-cut lettuce. For example, the agency launched in 2006 a “Leafy Greens Initiative.”

4 During the rulemaking process, the FDA received extensive comments on how to define a farm, and in its October 10,
2003, final rule on facility registration, it responded in detail. See 68 Federal Register pp. 58893–58974.
5 An FDA advisory panel acknowledged that the agency “conducts only limited inspections of food-producing farms,
except in emergencies.” FDA Science Board, FDA Science and Mission at Risk: Report of the Subcommittee on
Science and Technology
, November 2007.
6 Sources: FDA, Guide to Minimize Microbial Food Safety Hazards for Fresh Fruits and Vegetables, October 26, 1998,
at http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/
ProduceandPlanProducts/ucm064574.htm; and Guide to Minimize Microbial Food Safety Hazards of Fresh-cut Fruits
and Vegetables
, February 2008, at http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/
GuidanceDocuments/ProduceandPlanProducts/ucm064458.htm.
7 FDA, Guide to Minimize Microbial Food Safety Hazards for Fresh Fruits and Vegetables, October 26, 1998, at
http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/ProduceandPlanProducts/
ucm064574.htm; and Guide to Minimize Microbial Food Safety Hazards of Fresh-cut Fruits and Vegetables (see above
footnote for link). On September 2, 2008, FDA asked for public comments and scientific data to assist it in improving
its 1998 guidance.
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Among the key features of this cooperative and voluntary initiative are visits, in cooperation with
state agricultural officials, to farms (as well as produce packers and processors) to assess industry
efforts to improve lettuce safety and, if appropriate, “stimulate” further needed efforts.8 In 2007,
FDA issued a “Tomato Safety Initiative” modeled after the lettuce initiative and operated in
cooperation with Florida officials. FDA stated at the time that 12 different outbreaks of foodborne
illness (including from Salmonella) had been linked to fresh tomatoes, a majority of which were
grown in Florida.9
In July 2009, FDA published three guidance documents targeted at specific produce types: 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
.10 However, the agency now appears to be moving toward a potentially more hands-on
regulatory approach to produce safety. On February 18, 2010, it announced, “While USDA’s
Agricultural Marketing Service (AMS) is in the midst of evaluating a proposed marketing
agreement for the leafy green industry, the FDA is currently developing a proposed produce
safety regulation. It is our expectation that these products will take into account the diverse nature
of farming operations and that any marketing agreement would conform to any regulations that
may be promulgated by FDA.”11
In another recent instance of on-farm regulatory activity, the FDA on July 9, 2009, published final
rules to require shell egg producers to implement specific safety measures to prevent on-farm
contamination of eggs by Salmonella enteritidis (SE).12 The final rule observes that SE-
contaminated eggs have been a major source of foodborne illness and that on-farm prevention
measures are needed to reduce SE infections from eggs.13 The rule requires SE testing in poultry
houses, with follow-up tests on eggs if environmental testing is positive for the bacteria. Other
measures in the rule address the procurement of chicks and pullets, pest control and biosecurity
programs, disinfection of poultry houses where SE is found, and on-farm refrigeration of eggs.14
The rule applies to farms with 3,000 or more laying hens, unless they sell directly to consumers
or do not produce shell eggs for table use, although those with less than 50,000 layers have until

8 FDA, “Lettuce Safety Initiative,” August 23, 2006, at http://www.fda.gov/Food/FoodSafety/Product-
SpecificInformation/FruitsVegetablesJuices/FDAProduceSafetyActivities/ucm115906.htm, which notes that regulatory
action would be considered if deemed appropriate to prevent contamination.
9 “FDA Implementing Initiative to Reduce Tomato-Related Foodborne Illnesses,” June 12, 2007. Florida was cleared as
the source in the more recent (April-July 2008) Salmonella-linked outbreak in which tomatoes were first suspected.
10 These documents were accessed February 25, 2010 at http://www.fda.gov/Food/
GuidanceComplianceRegulatoryInformation/GuidanceDocuments/ProduceandPlanProducts/default.htm.
11 “USDA and FDA Coordinating Efforts to Ensure Safety of Produce: FDA Invites Public Comments to Inform Future
Rulemaking,” accessed February 25, 2010, at http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/
ucm200965.htm. The FDA’s docket notice inviting public comments was published in the February 23, 2010, Federal
Register
. The AMS leafy greens marketing agreement is described in the “Leafy Greens Marketing Agreement” section
of this CRS report.
12 74 Federal Register pp. 21928-21929.
13 The final rule is at 74 Federal Register pp. 33030-33101.
14 “Biosecurity” refers to agricultural practices intended to reduce or prevent the introduction of infectious diseases on a
farm or other production facility and includes practices such as limiting access by personnel and vehicles; reviewing
and screening introduced items such a seed, feed, and new animals; and controlling vermin. More recently, biosecurity
programs have incorporated elements to protect against terrorism, vandalism, and other intentional acts that could
compromise disease control, whether or not they were the primary aim of the illicit acts.
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July 9, 2012, to comply. FDA published a guidance document on April 13, 2010, to help small
producers comply with the new rule.15
Food Safety and Inspection Service
USDA’s Food Safety and Inspection Service (FSIS) regulates the safety, wholesomeness, and
proper labeling of most domestic and imported meat and poultry and their products (and,
beginning soon, of catfish products), under authority of the Federal Meat Inspection Act (FMIA)
as amended (21 U.S.C. 601 et seq.), and the Poultry Products Inspection Act (PPIA) as amended
(21 U.S.C. 451 et seq.). Agency officials periodically have stated that these laws provide no direct
authority to regulate on-farm activity. Under both statutes, agency oversight begins when animals
arrive at slaughter facilities. These laws direct the Secretary of Agriculture to prevent adulterated
meat and poultry from entering commerce by examining all animals just before slaughter (ante-
mortem), with additional provisions requiring post-mortem inspections of all carcasses and of
food products made from these carcasses (21 U.S.C. § 455 and §§ 603-606).
Farmers and ranchers do not appear to be among the persons, establishments, and other firms
subject to the provisions of these acts, including record-keeping requirements and penalties for
noncompliance. Neither act “speaks to how livestock are produced, maintained, or managed,”
according to a 1998 report issued by the Institute of Medicine of the National Academy of
Sciences.16
FSIS and livestock industry officials have asserted that agricultural producers are indirectly
regulated under these laws. For example, slaughter establishments are not to accept unhealthy or
mistreated animals that may harbor diseases and pathogens dangerous to humans. Such animals
can spread contamination in plants, as well as result in rejection or other enforcement actions by
inspectors and/or costly (if ostensibly voluntary) product recalls, it is argued. Moreover, FSIS has
worked with animal industry organizations to encourage producers to adopt voluntarily “best
practices” aimed at reducing the spread of pathogens like E. coli O157:H7 among live animals.
Other Programs Affecting Producers
Regulation of Animal Drugs and Feeds
Under the FFDCA, FDA’s Center for Veterinary Medicine regulates the manufacture and
distribution of drugs and feeds for animals. Drugs are used in food-producing animals to treat and
prevent animal diseases and to improve growth rates, such as with antibiotics. If unapproved or
used improperly, they can compromise human food safety. Another regulatory example affecting
producers is FDA’s rule prohibiting the use, in animal feeds, of materials of ruminant origin. This
rule is aimed at preventing the spread of bovine spongiform encephalopathy (BSE, or “mad cow
disease”); though rare, a human form of BSE can be contracted if infected tissues are consumed.17

15 Guidance for Industry: Prevention of Salmonella Enteritidis in Shell Eggs During Production, Transportation, and
Storage; Small Entity Compliance Guide
, accessed April 21, 2010, at http://www.fda.gov/Food/
GuidanceComplianceRegulatoryInformation/GuidanceDocuments/SmallBusinessesSmallEntityComplianceGuides/
ucm207507.htm.
16 Ensuring Safe Food from Production to Consumption, National Academies Press, Washington, D.C., 1998.
17 See the FDA website at http://www.fda.gov/cvm/bsetoc.html.
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In addition to drug approvals and oversight of feed manufacturers, FDA also works with FSIS,
which tests for violative residues of antibiotics and other drugs in meat and poultry and reports
them to FDA. FDA can conduct follow-up inspections (often done through state agencies) of
livestock producers and others. Another cooperative effort between FDA and state milk control
officials is the National Drug Residue Milk Monitoring Program, which routinely tests raw milk
for certain drug residues.
Regulation of Pesticides
The Environmental Protection Agency (EPA) regulates the sale and use of pesticides, including
those used to control insects, weeds, mold, and other pests affecting food crops, under the Federal
Insecticide, Fungicide, and Rodenticide Act (FIFRA; P.L. 92-516). It is a violation of FIFRA to
use a pesticide that is inconsistent with its approved label instructions. Under the FFDCA, EPA
sets allowable residue levels, called tolerances, for pesticides used in food production. Tolerances
are set to ensure that harm to health is prevented with “a reasonable certainty.” Foods with
residues that exceed tolerances, or that contain a residue that lacks an established tolerance, are
considered adulterated under the FFDCA. Generally, the FDA monitors and enforces residue
limits, while EPA and the states enforce FIFRA’s provisions.18
The FDA Science Board, in its November 2007 report, argued that these programs have their
limitations: “These [FDA and EPA] conditions are meant to prevent the presence of dangerous
amounts of those chemicals in food. However, monitoring of compliance with approved usage is
poorly funded and episodic. State and local authorities have more to say about on-farm practices,
but their monitoring capabilities are severely limited.”19
Animal Health Programs
Under the Animal Health Protection Act (7 U.S.C. § 8301 et seq.), USDA’s Animal and Plant
Health Inspection Service (APHIS) is to protect U.S. livestock and poultry from domestic and
foreign diseases and pests. Some of these diseases, including BSE, avian influenza (AI), and
bovine tuberculosis, also have public health implications. Salmonella enteritidis, an infection
found among poultry (see previous discussion), is a major cause of foodborne illness in humans.
Although the APHIS programs often are cooperative, voluntary efforts between APHIS, states,
and industry, APHIS does have the authority to impose quarantine, eradication, and other
regulatory requirements on producers. These requirements relate to the control animal diseases,
however, not food contamination.
Another APHIS cooperative program is the national animal identification (ID) program, which
the agency is implementing nationally (on a voluntary basis) to improve the ability to pinpoint
and control animal diseases. Some policymakers believe animal ID, which seeks to document the
movements of individual animals, or herds or flocks, from place of birth to slaughter, can
contribute to food safety, particularly if it can be linked to a farm-to-retail food traceability
system. (Other policymakers counter that animal ID should be limited to animal disease control.)

18 Source: CRS Report RL31921, Pesticide Law: A Summary of the Statutes, by Linda-Jo Schierow.
19 FDA Science and Mission at Risk: Report of the Subcommittee on Science and Technology.
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Federal Marketing Programs
USDA’s Agricultural Marketing Service (AMS) oversees a number of programs intended to
assure that various agricultural products meet specified quality and grade standards, sometimes
involving safety attributes. For example, 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 and agreements that can include quality (and possibly, safety) standards.
Under the Agricultural Marketing Act of 1946 (7 U.S.C. § 1621 note), AMS has implemented a
wide range of voluntary testing and process verification programs. Funded by industry user fees,
these AMS services use independent, third-party audits and other standardized procedures to help
producers certify that their products meet buyer specifications.20 Although some of these
programs can be, and are, designed to ensure the safety of certain food commodities from a public
health standpoint, they are not regulatory by nature. Rather, they are intended to facilitate
commercial agreements in the trade or to provide consumers with more information about their
prospective purchases.21
Leafy Greens Marketing Agreement
AMS in October 2007 had invited comments on whether to create such a federal marketing
program that specifically would commit handlers (packers, processors, shippers) of leafy greens,
including lettuce and spinach, to meet prescribed safety standards.22 On June 8, 2009, a group of
agricultural associations formally requested that AMS begin the steps toward establishment of a
national marketing agreement for leafy greens. The key difference between an agreement and an
order is that an agreement is legally binding only on those who voluntarily join it, whereas an
order is binding on all handlers. Nonetheless, sponsors of the request for a national agreement
(including major produce industry associations) anticipate broad participation.
A similar state order was adopted in California in 2007 and by Arizona later that year. Under the
California Leafy Green Products Handler Marketing Agreement (LGMA), nearly 120 handlers
(essentially, those who first handle the product as it leaves the farm), representing 99% of the
volume of California-grown leafy greens, have committed to selling products grown in
compliance with the food safety practices accepted by the LGMA board. Members submit to
mandatory third-party audits to verify compliance.23 Reportedly, California and Arizona represent
approximately 90% of leafy greens production, and a national agreement would seek to cover the
nation’s remaining 10%.24

20 More detailed information about this programs was presented in May 14, 2009, testimony before the House
Agriculture Subcommittee on Horticulture and Organic Agriculture by AMS Acting Administrator David Shipman. It
can be accessed at http://agriculture.house.gov/testimony/111/h051409/Shipman.pdf. Detailed information about these
programs can be accessed through the AMS website at http://www.ams.usda.gov.
21 For a more detailed analysis of USDA’s on-farm authorities with respect to food safety, see CRS Report R40577,
USDA Authority to Regulate On-Farm Activity, by Cynthia Brougher.
22 An advance notice of proposed rulemaking appeared in 72 Federal Register pp. 56678-80. A provision in the House-
passed farm bill in 2007 (H.R. 2419) would have expressly authorized the implementation of quality-related food safety
programs under marketing orders for specialty crops. The provision was deleted from the final version in 2008 (P.L.
110-246).
23 California Leafy Green Products Handler Marketing Agreement website, at http://www.caleafygreens.ca.gov/.
24 “Produce industry petitions USDA for leafy greens marketing agreement,” Food Chemical News, June 15, 2009.
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The USDA (AMS) role in a national agreement is to publish a notification regarding the request
and to conduct public hearings; these hearings were conducted in fall 2009.25 If adopted (possibly
in 2010), the agreement would be managed by an industry committee and would provide for AMS
inspectors, or inspectors designated by AMS, to audit producers who supply the participating
handlers. These inspections would be conducted on a fee-for-service basis, although AMS asked
Congress to provide it with $2.3 million to write and initiate an agreement.
Such audits would be to ensure that the good agricultural production, handling, and related
practices the agreement stipulates—referred to as “metrics”—are being followed. These practices
are aimed at enhancing the safety aspects of produce quality. Some food safety advocacy
organizations have expressed concern that AMS, an agency whose primary mandate is providing
quality and grading services to industry, essentially would be conducting safety inspections,
which is within the purview of FDA.26 The metrics themselves are not regulatory FDA standards
under the FFDCA; however, the agreement’s drafters expect that any violations of FDA law will
be reported to the FDA by agricultural inspectors.27
Selected Proposals in Congress28
In the 111th Congress, bills that seek to regulate agricultural producers directly have included H.R.
759 (Dingell), which was reintroduced as H.R. 2749; H.R. 1332 (Costa); H.R. 875 (DeLauro);
and S. 510 (Durbin). The Costa and Durbin bills focus on safety standards for fresh fruits and
vegetables; the Dingell bill originally covered other types of food production (except animal-
based commodities), as described below, but has since been scaled back. The DeLauro bill would
have combined all federal food safety responsibilities under a single new Food Safety
Administration, and imposed various new record-keeping, risk reduction, and certification
requirements on both the domestic and imported food systems. With regard to farms, the DeLauro
bill first would have defined a “food production facility” to be “any farm, ranch, orchard,
vineyard, aquaculture facility, or confined animal feeding operation.”
However, the Dingell bill (H.R. 2749) became the House legislative vehicle for food safety
changes. It was amended and approved by a House Energy and Commerce subcommittee on June
10, 2007, and further amended and approved by the full Energy and Commerce Committee on
June 17, 2009. In the Senate, the Durbin bill (S. 510) was modified and approved by the Senate
Health, Education, Labor, and Pensions (HELP) Committee on November 18, 2009, and reported
on December 18, 2009. The following discussion thus focuses on H.R. 2749 and S. 510.

25 Information on the hearings was available on the AMS website.
26 Concerns about the use of marketing agreements as food safety instruments were aired at a July 29, 2009 hearing
before the House Committee on Oversight and Government Reform’s Subcommittee on Domestic Policy,
http://domesticpolicy.oversight.house.gov/story.asp?ID=2557.
27 National Leafy Greens Marketing Agreement, “Frequently Asked Questions,” at http://www.nlgma.org/faqs.php
(accessed June 19, 2009). The greens to be covered by the national agreement would be arugula, cabbage (red, green,
and savoy), chard, cilantro, endive, escarole, kale, lettuce (iceberg, leaf, butterhead, and romaine), parsley, raddichio,
spinach, spring mix (baby leaf items including but not limited to cress, dandelion, endigia, mache, mizuna, tat soi,
winterpurslane), or any other leafy green recommended by the committee and approved by USDA.
28 See also CRS Report R40443, Food Safety: Selected Issues and Bills in the 111th Congress, by Geoffrey S. Becker.
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Dingell Bill Overview (H.R. 2749)
Section 104 of the Dingell bill, as amended and approved by the House Energy and Commerce
Committee, and as modified prior to final House action, creates a new section 419A of the
FFDCA. It would require the HHS Secretary to publish within 18 months of enactment a notice
of proposed rulemaking, and within three years after such date, final rules, establishing scientific
and risk-based food safety standards for the growing, harvesting, processing, packing, sorting,
transporting, and holding of those types of raw agricultural commodities that are a fruit,
vegetable, nut, or fungus, and for which the Secretary has determined such standards are
reasonably necessary to minimize the risk of serious adverse health consequences or death to
humans or animals.
The Secretary is authorized to include in these regulations procedures and practices that the
Secretary determines to be reasonable to prevent known or reasonably foreseeable biological,
chemical, and physical hazards, including natural ones, that may be intentionally or
unintentionally introduced. The regulations may also include minimum safety standards, and
address manure use, water quality, employee hygiene, sanitation and animal control, and
temperature controls, as the Secretary determines to be reasonably necessary. They could provide
for coordination of education and enforcement activities and must provide a reasonable time for
compliance, taking into account the needs of small businesses for additional time, among other
permitted activities. In developing these regulations, the Secretary would be required to take into
consideration (consistent with public health) “the impact on small-scale and diversified farms,
and on wildlife habitat, conservation practices, watershed-protection efforts, and organic
production methods.”
A food would be adulterated under terms of the FFDCA if it is grown, harvested, packed, sorted,
transported, or held under conditions that do not meet these requirements, if applicable. The
Dingell bill also would require the Secretary to update the 1998 FDA guidance for minimizing
hazards in fresh fruits and vegetables.
Other provisions in the Dingell bill also would, or at least could, have impacts on agricultural
producers. These include the registration requirements under section 101, the records access
requirements under section 106, the food traceability system to be established under section 107,
and a change in the reportable food registry under section 112. These provisions are discussed at
length in the next section of this CRS report, “Farm Interest Concerns with H.R. 2749.”
Farm Interest Concerns with H.R. 274929
Some videos and emails have circulated on the Internet asserting that pending food safety
legislation would undermine or even destroy the nation’s small and organic farms, to the benefit
of industrialized agriculture.30 In fact, none of the original bills’ farm-related provisions appear to
explicitly exempt such operations, other than directing that the needs of small businesses be
considered during implementation.

29 Renée Johnson, Specialist in Agricultural Policy (7-9588), contributed to this section of the report.
30 See, for example: http://www.youtube.com/watch?v=eDl6RjYaOt4 (video) and articles; http://educate-yourself.org/
cn/HR875andS425organicfarmingban13mar09.shtml; and http://www.opednews.com/articles/FOOD-SAFETY-
REGULATIONS—by-Linn-Cohen-Cole-090108-947.html.
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The Organic Consumers Association (OCA) sought on the one hand to challenge what it viewed
as the “hysteria” and unsubstantiated facts that circulated about H.R. 875 in particular, and on the
other hand to criticize sharply the bill’s language. It posted an article on its website that
commented:
It’s really a fight about government control. The loose terms and definitions of what H.R. 875
would actually do—enact more stringent and much-needed safety regulations—left room for
organic and biodynamic growers to become fearful of government intervention. Section 206 of
the bill, which defines a “food production facility,” is so ambiguous that individuals beyond large
farms (i.e. backyard gardeners) could be penalized and subject to review by the government.31
In a posting on her own website, Representative DeLauro sought to challenge the “myths” about
her bill, arguing that its focus was to ensure the safety of food in interstate commerce, not to
regulate or penalize backyard gardens or farmers markets. H.R. 875 would not interfere with
organic farming, and has the support of all major consumer and food safety groups, she
asserted.32
One consumer advocacy organization acknowledged that some of the bills contained provisions
that could prove problematic for small farms and processors and that “one-size-fits-all regulation
only tends to work for one size of agriculture—the largest industrialized operations.” However, it
urged affected interests essentially to seek improvements in the bills rather than to defeat “any
attempt to fix our broken food safety system.”33 At a conference in early April 2009, Carol Tucker
Foreman, of Consumer Federation of America’s Food Policy Institute, agreed that Congress may
want to consider tailoring some requirements based on different types of operations or to phase in
requirements for some operations. Foreman had suggested, for example, possibly considering
exempting direct-to-market farms (e.g., those serving farmers markets).34
The Dingell bill (H.R. 2749) has since overtaken the DeLauro bill (H.R. 875) as the House food
safety vehicle, and it has been altered several times in response to various criticisms by
agricultural interests. H.R. 2749 was modified during committee action to exempt farms that
market directly from some of the new traceability provisions. However, some small farm
advocates continued to express their opposition to this and other major sections of the bill. For
example, although the bill’s new facility registration requirements continued to exempt farms,
could they be applied by FDA to a farm that does any processing, even of its own food, such as
washing and packaging fruits and vegetables before selling them? These and other provisions in
the measure appeared to create a regulatory framework that would heavily burden small farms
and local food processors, “the very people who provide a safe, healthy alternative to the
industrial food supply.”35

31 Alexandra Gross, “Food Fight: The Food Safety Bill Is Cause for Concern, Not Panic,” E Magazine, March/April
2009, at http://www.organicconsumers.org/articles/article_17492.cfm.
32 “Myths and Facts, H.R. 875—The Food Safety Modernization Act,” accessed April 6, 2009, at
http://delauro.house.gov/files/HR875_Myths_Facts1.pdf.
33 Food & Water Watch, “Background on H.R. 875, accessed March 19, 2009 at http://www.foodandwaterwatch.org/
food/foodsafety/background-on-h-r-875?searchterm=h.r.+875.
34 These remarks were made at the Farm Foundation Forum, “The Future of Food Safety Regulation.” The remarks
came near the end of the program during the question and answer segment. An audio link is at
http://www.farmfoundation.org/news/articlefiles/363-20090407_pv_farm_foundation.mp3.
35 Farm-to-Consumer Legal Defense Fund, “H.R. 2749’s Real Impacts: a Response to Consumers’ Union,” accessed on
the Internet July 22, 2009, at http://www.farmtoconsumer.org/HR2749-response.htm.
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One mainstream agricultural publication had observed, “[S]mall farms and organic growers are
objecting to any requirement that they register their facilities and be subject to possible inspection
by federal authorities. Apparently they are as pure as the driven snow and claim that food borne
diseases only come from ‘some multinational food corporation’ (e.g., ignore CDC data on
outbreaks at fairs, festivals, campylobacter from small local dairy farms, etc.)”36
Later, as the Dingell bill (H.R. 2749) was being readied for consideration by the full House, some
of the more traditional agricultural groups weighed in with their own concerns. In a June 26,
2009, letter to the House Energy and Commerce Committee, 13 groups asserted that H.R. 2749
would create new on-farm regulatory authorities that would be redundant with USDA oversight,
affecting agricultural practices that the FDA does not have the funding or expertise to regulate,
and that the bill would impose significant costs on small farms and food producers while doing
little to improve safety, and would violate U.S. trade commitments, inviting retaliation by trading
partners against U.S. agricultural exports.37
Farm-Related Modifications in H.R. 2749
After reaching further compromises with farm interests, sponsors brought to the House floor an
amended bill with additional changes regarding the treatment of farms, including the following.
On-Farm Standards
The committee-approved bill would have authorized the imposition of on-farm standards for any
plant or fungus (in other words, all crops but not animal-based food commodities) for which the
HHS Secretary determined such standards are reasonably necessary to minimize the risk of
serious adverse health consequences or death to humans or animals. The final House bill limits
this standards authority to a fruit, vegetable, nut, or fungus (section 104).
Facility Registration Requirements
The committee-approved bill would not require farms (or retail food establishments) to begin
registering—which for facilities is to become an annual requirement to include a $500 annual fee.
To clarify this continuing exemption, the final House bill added extensive new language defining
the meaning of a farm, which is intended to ensure that those farms marketing directly to
consumers, among other specified activities, will not be newly subjected to such registration
requirements. For example, a farm means “an operation in one general physical location devoted
to the growing and harvesting of crops, the raising of animals (including seafood), or both.” It
includes an operation that packs, holds, manufactures, or processes food, so long as it is produced
and consumed on the farm; an operation that sells food directly to consumers if the sales value
from such consumer sales exceeds the value of food products sold to all other buyers; and
operations that manufacture grains or other feed stuffs grown there and only distributed directly
to another farm for its consumption there (Section 101).

36 Gary Blumenthal, “Policy Roundup,” World Perspectives, Inc., daily news for March 11, 2009.
37 The letter was signed by the American Farm Bureau Federation, the Pet Food Institute, and 11 commodity
associations such as the National Association of Wheat Growers and the National Milk Producers Federation. Farm-
related concerns also were explored at a July 16, 2009, hearing before the House Agriculture Committee.
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Records Access
The committee-approved bill, which broadens the HHS Secretary’s authority to access records,
would also have subjected farms to such records access (and record-keeping) provisions. The
final House bill continues to exempt farms from records access requirements, except where the
article of food is a fruit, vegetable, or fungus that has a standard, or is the subject of an active
foodborne illness investigation and is not a grain or similarly handled commodity—wheat, corn,
grain sorghum, barley, oats, rice, wild rice, rye, soybeans, legumes, sugar cane, sugar beets,
sunflower seed, canola, safflower, flaxseed, mustard seed, crambe, seasame seed, camelina,
cottonseed, cocoa beans, grass hay, and honey, and any other commodity determined by the HHS
Secretary in coordination with the Secretary of Agriculture. Also, any record-keeping regulations
affecting farms must be promulgated in consultation the Secretary of Agriculture (section 106).
Food Traceability
The committee-approved bill would require the HHS Secretary to establish a tracing system able
“to identify each person who grows, produces, manufactures, processes, packs, transports, holds,
or sells such food in as short a timeframe as practicable but no longer than 2 business days.” This
also would entail new record-keeping requirements for those in each segment of the food
industry. The committee bill would exempt foods produced on a farm and sold directly to
consumers, restaurants or grocery stores, except for a requirement that they keep records for at
least 6 months on which restaurants or grocery stores received their foods. The committee bill
also authorized the Secretary to partially exempt farms (or foods, facilities, restaurants) if he/she
determines that traceability is not necessary to protect the public health.
Additional language was added to the final House bill to satisfy agricultural interests that would
also require the HHS Secretary to coordinate with the Secretary of Agriculture in both conducting
pilot projects on traceability (a prerequisite to traceability regulations) and issuing such
regulations; the nature of the impact of the regulations on farms also must be taken into account.
Furthermore, the final House bill contains extensive new language intended to limit the system’s
applicability regarding farms that grow and store grain or similarly handled commodities (see
“Records Access,” above, for specific commodities) (section 107).
Reportable Food Registry
The Administration is now implementing a provision of the FDA Amendments Act of 2007 (P.L.
110-85) which requires food facilities to report foods for which there is a reasonable probability
of serious adverse health consequences or death to humans or animals. The committee-approved
bill would extend this reporting requirement to farms (and restaurants and retail food
establishments). Under a change in the final House bill, farms (and restaurants, retail food
establishments) that are unable to provide such information through a new electronic portal must
be given an alternative means for reporting (section 112).
Other Farm-Related Modifications
The committee-reported bill would exempt foods and facilities regulated by USDA under the
meat, poultry products, or egg inspection acts; it also would exempt farms to the extent they raise
animals sourced for such USDA-regulated foods. The final House bill adds language to ensure
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that the animals themselves are also exempt and that USA-approved, state-inspected meat and
poultry facilities are exempt as well (section 5).
Durbin Bill Overview (S. 510)
Section 105 of the bill offered by Senator Durbin (S. 510), as modified by the HELP Committee,
would create a new FFDCA Section 419. It would require, within one year, in consultation with
USDA and state agriculture departments (including with regard to the national organic foods
program), the publication of a notice of proposed rulemaking for “science-based minimum
standards for the safe production and harvesting of those types of fruits and vegetables that are
raw agricultural commodities for which the [HHS] Secretary has determined that such standards
minimize the risk of serious adverse health consequences or death.” The proposed rules are to
include, with respect to growing, harvesting, sorting, packing, and storage operations, minimum
standards related to soil amendments, hygiene, packaging, temperature controls, animal
encroachment, and water; and they are to “consider hazards that occur naturally, may be
unintentionally introduced, or may be intentionally introduced, including by acts of terrorism.”
Under S. 510, final rules would have to spell out “practices as the Secretary determines to be
reasonably necessary to prevent the introduction of known or reasonably foreseeable biological,
chemical, and physical hazards, including hazards that occur naturally, may be unintentionally
introduced, or may be intentionally introduced, including by acts of terrorism, into fruits and
vegetables that are raw agricultural commodities and to provide reasonable assurances that the
produce is not adulterated” under the FFDCA. S. 510 would require the Secretary to prioritize
regulations for specific fruits and vegetables that are raw agricultural commodities that have been
associated with foodborne illness outbreaks. It also includes provisions for public input, timelines
for implementation of rules, and a system for granting variances for states and foreign
governments.
The HELP Committee added language to the original bill that requires the proposed rules to
“provide sufficient flexibility to various types of entities engaged in the production and
harvesting of raw agricultural commodities, including small businesses and entities that sell
directly to consumers, and be appropriate to the scale and diversity of the production and
harvesting of such commodities.” Committee-added language also requires consideration
(consistent with public health protection) of federal policies and standards regarding natural
resources conservation, wildlife conservation, and environmental practices. Moreover, new
regulations are not to include “any requirements that conflict with or duplicate the requirements”
of the national organic foods program (consistent with public health protection).
Treatment of Farms Under Other S. 510 Provisions
Inspection of Records
In S. 510, § 101 amends the circumstances under which the HHS Secretary could access the
records of facilities (see above definitions for what is or is not considered a facility). However, it
does not appear to change the definition of a facility; thus farms would not be newly impacted by
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this provision, at least directly.38 However, farms that fall within the definition of “facility” (e.g.,
those that process some or all of their production for sale) would be affected.
Registration of Food Facilities
Under § 102, S. 510 would require all food facilities to register bienially, and there is new
language regarding what information should be provided and regarding terms for suspending
registrations. However, this provision would not alter the definition of “facility” in the current
FFDCA; farms are not affected unless they process food for sale. In addition, S. 510 does not set
a registration fee, unlike the House-passed food safety bill (H.R. 2749).
Hazard Analysis and Risk-Based Preventive Controls
This provision (§ 103) establishes a new FFDCA § 418, requiring the owner, operator, or agent in
charge of a facility to develop, implement, and keep records on preventive controls for food
safety. Section 103 references the current definition of “facility” under FFDCA § 415. Therefore,
farms are not affected unless they process food for sale. This section of the bill, as modified by
the committee, explicitly permits the Secretary to exempt or modify compliance requirements for
those facilities “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.”
Targeting of Inspection Resources for Domestic Facilities, Foreign Facilities,
and Ports of Entry; Annual Report

This section (§ 201) specifically requires the Secretary to inspect food facilities (as defined under
FFDCA § 415) and to allocate inspection resources according to the risk profiles of the facilities.
Generally, those determined to be of lower risk must be inspected at least once every four years;
those of higher risk within two years of enactment and then every year thereafter. Again, farms
that process food for sale would be subject to these inspections; others would not because they are
excluded under current law from the definition of a “facility.”
Enhancing Traceback and Record-Keeping
This provision (§ 204) requires the Secretary, in consultation with USDA and state officials, to
improve the capacity of FDA to effectively and rapidly track and trace fruits and vegetables that
are raw agricultural commodities in the event of an outbreak. It would require proposed rules
within three years of enactment for standards on the type of information, format, and time frame
for persons to submit records to aid in such tracebacks. Also, within nine months of enactment,
the Secretary is required to establish at least three pilot projects in coordination with the produce
industry to test and evaluate methods for rapidly and effectively tracking and tracing fruits and
vegetables in the event of a foodborne illness outbreak. If, as it appears, this provision would not

38 It could be argued that this provision—and other provisions of S. 510 not readily applicable to farms—might be
indirectly affected if, for example, the buyers of their products were to require a farm supplier to meet new contractual
terms to help the buyer meet any newly enacted food safety requirements.
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require the establishment of a traceability system, then neither facilities nor farms would be
subjected to newly legislated traceback rules.
The HELP Committee added language to this section of the bill requiring the Secretary to
consider the impact of the standards regulations on farms and small businesses, the findings of the
pilot projects, and existing trade obligations. Furthermore, those subject to the new produce
standards that are not facilities under the FFDCA could not be required by the Secretary to submit
records other than distribution records kept in the normal course of business, among other
committee modifications.
Concluding Observations on the Bills’ Provisions
The farm-related provisions of the original House and Senate bills generally made no explicit
distinctions between agricultural producers of different sizes or of varying production practices.
Concerns raised by groups representing organic producers, smaller-scale farmers, and others have
since led sponsors of both versions to add new language aimed at recognizing any special
circumstances faced by, for example, smaller farms, those that market directly to consumers, and
so forth. At issue is whether these changes will satisfy farm interests, what, if any additional
modifications should be made, and their potential impact on food safety.
The House-passed and pending Senate food safety bills have numerous elements that appear to be
similar to each other, including new record-keeping and records access provisions, changes in
food registration, and a mandate for preventive food safety plans for food facilities and for
produce, for example. However, these seemingly similar provisions appear to be somewhat more
prescriptive under the House version and/or could have a greater potential impact on producers,
regardless of size, production, and/or marketing practices. That is a key reason that H.R. 2749
appears to contain more specific language than existed in S. 510 in order to limit the applicability
of the bill—or a number of its specific provisions—to farms generally. For example, H.R. 2749
specifically exempts all foods and facilities regulated by USDA under the meat and poultry
inspection laws, as well as the animals used in these products and the farms that raise them.
Again, although neither bill initially distinguished between farms of different sizes or operating
practices, provisions have since been added to both that direct the Secretary to take such
distinctions into account. For example, the on-farm produce standards that must be issued under §
104 of the House bill require the HHS Secretary to take into account “the impact on small-scale
and diversified farms, and on wildlife habitat, conservation practices, watershed-protection
efforts, and organic production methods.” The Senate HELP Committee added language with
similar intentions to its produce safety section (§ 105).
Some small-farm interests have continued to seek changes in the Senate bill. The National
Sustainable Agriculture Coalition (NSAC) has asserted that the measure would subject farm-
based facilities with value-added processing or that commingle products with neighboring farms
to extensive FDA regulation regardless of their risk or scale. NSAC has called for amendments to
address this concern, including authority to exempt from regulation farms with relatively low
risks or sales and adoption of language in a freestanding Senate bill (S. 2758) that would create a
USDA competitive grants program to provide food safety training and technical assistance to
smaller-sized producers, processors, and produce wholesalers.39 Such proposals conceivably

39 Possible changes in the Senate bill being sought by small farm advocates were discussed at some length by NSAC on
its website at http://sustainableagriculture.net/blog/senate-food-safety-bill-includes-improvements-for-farmers/.
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could be offered either as part of a manager’s amendment package of changes, or as separate floor
amendments, when the bill reaches the full Senate (such action was anticipated but not
necessarily assured in spring 2010).
If and when S. 510 passes through the Senate and reaches a conference with the House, it is
possible, if not likely, that further modifications affecting the agricultural sector could be made.

Author Contact Information

Geoffrey S. Becker

Specialist in Agricultural Policy
gbecker@crs.loc.gov, 7-7287


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