Food Safety on the Farm: Federal Programs
and Legislative Action
Renée Johnson
Specialist in Agricultural Policy
December 15, 2010
Congressional Research Service
7-5700
www.crs.gov
RL34612
CRS Report for Congress
P
repared for Members and Committees of Congress
Food Safety on the Farm: Federal Programs and Legislative Action
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 certain naturally occurring contaminants.
There is interest in examining on-farm practices, given continued major outbreaks of foodborne
illness involving both domestically produced and imported foods. An example is the case in
April-July 2008, when more than 1,000 persons in more than 40 states and Canada were found to
be infected with the same unusual strain of bacteria (Salmonella Saintpaul). Most recently, in
May 2010, a large-scale recall of more than 550 million shell eggs has been linked to concerns
about a nationwide increase in Salmonella Enteritidis (SE) infections.
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 food safety legislation passed both the House (H.R. 2749)
in July 2009 and the Senate (S. 510) in November 2010. The House-passed bill 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. Provisions in the Senate-passed bill, S. 510, which includes a section requiring produce
safety standards, also would affect on-farm production.
As both of these bills progressed, Congress continued to modify provisions to address the
potential effects of proposed food safety requirements on small farms and food processors, and
also on organic, direct-to-market, and sustainable farming operations. For example, although the
House Energy and Commerce Committee amended H.R. 2749 to address small-farm concerns,
the version passed by the full House in June 2010 contained additional changes addressing
agricultural interests. Similarly, the version of S. 510 reported by the Senate Health, Education,
Labor, and Pensions Committee in December 2009 was further modified to address small-farm
concerns as part of a substitute manager’s amendment agreed to by Senate leaders that was
released in August 2010. Additional changes were made to address small farm concerns again in a
second substitute amendment to S. 510 (S.Amdt. 4715) that was offered and passed off the floor
in November 2010. Further action on the legislation remains pending for various procedural
reasons. (For more details, see CRS Report R40443, Food Safety in the 111th Congress: H.R. 2749
and S. 510)
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Food Safety on the Farm: Federal Programs and Legislative Action
Congressional Research Service
Food Safety on the Farm: Federal Programs and Legislative Action
Contents
Introduction ................................................................................................................................ 1
Food Safety Hazards on the Farm................................................................................................ 2
Federal Food Safety Programs..................................................................................................... 3
Food and Drug Administration .............................................................................................. 3
Food Safety and Inspection Service....................................................................................... 6
Other Programs Affecting Producers ..................................................................................... 7
Regulation of Animal Drugs and Feeds ........................................................................... 7
Regulation of Pesticides .................................................................................................. 7
Animal Health Programs ................................................................................................. 8
Federal Marketing Programs ........................................................................................... 8
Leafy Greens Marketing Agreement ................................................................................ 8
Legislative Action ..................................................................................................................... 10
Food Safety Bill Overview.................................................................................................. 10
Farm Interest Concerns with Food Safety Bills .................................................................... 11
House Debate................................................................................................................ 11
Senate Debate ............................................................................................................... 13
Mitigating Effects on Small Business and Farming Operations ...................................... 16
Treatment of Farms in the House and Senate Food Safety Bills ........................................... 19
H.R. 2749 (House-Passed) ............................................................................................ 20
S. 510 (Senate-Passed) .................................................................................................. 23
Concluding Observations on the Bills’ Provisions................................................................ 26
Tables
Table 1. U.S. Farms and Food Manufacturers, 2007................................................................... 18
Contacts
Author Contact Information ...................................................................................................... 27
Acknowledgments .................................................................................................................... 27
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Food Safety on the Farm: Federal Programs and Legislative Action
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.)
• In July 2010, CDC noticed a spike in cases of infection with Salmonella
Enteritidis, a strain commonly associated with shell eggs, which are regulated by
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FDA.1 In August, FDA found the same pathogen on two egg farms in Iowa,
leading to the nationwide recall by the companies of more than 500 million eggs
packaged under several brand names.2 According to the CDC, this is the largest
such outbreak reported since the start of its outbreak surveillance in the early
1970s.3 This investigation is ongoing. However, FDA samples collected at the
facilities matching the DNA fingerprint of the outbreak strain have been detected
from manure and traffic areas in and around the facility (such as walkways,
equipment, other surfaces), as well as from the mill providing finished feed to
pullets raised at and distributed at both of the egg facilities.4
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.5
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
1 USDA regulates processed eggs, and grades shell eggs for quality (such as grade and size), but does not oversee the
safety of shell eggs.
2 FDA, “Salmonella Enteritidis Outbreak in Shell Eggs,” http://www.fda.gov/Food/NewsEvents/WhatsNewinFood/
ucm222684.htm.
3 FDA, “Frequently Asked Questions and Answers: FDA’s Investigation into the Salmonella Enteritidis Outbreak
Involving the Recall of Shell Eggs,” http://www.fda.gov/Food/NewsEvents/WhatsNewinFood/ucm223723.htm.
4 FDA, “Recall of Shell Eggs,” http://www.fda.gov/Safety/Recalls/MajorProductRecalls/ucm223522.htm#483.
5 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.
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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
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.6
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.”7
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
6 A more detailed legal analysis is in CRS Report RS22939, FDA Authority to Regulate On-Farm Activity. FDA’s own
arguments in support of its on-farm authority can be found in a final rule to regulate egg production to control
Salmonella enteritidis, 74 Federal Register 33030, July 9, 2009 (p. 33049), http://edocket.access.gpo.gov/2009/pdf/E9-
16119.pdf. See also CRS Report RS22600, The Federal Food Safety System: A Primer.
7 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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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,”
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 FFDCA § 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.8
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.9 Rather, the
8 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.
9 An FDA advisory panel acknowledged that the agency “conducts only limited inspections of food-producing farms,
(continued...)
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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.10 The agency’s agricultural guidance documents11
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.”
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.12 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.13
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.14 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.”15
(...continued)
except in emergencies.” FDA Science Board, FDA Science and Mission at Risk: Report of the Subcommittee on
Science and Technology, November 2007.
10 FDA, Guide to Minimize Microbial Food Safety Hazards for Fresh Fruits and Vegetables, October 1998,
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, http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/
ProduceandPlanProducts/ucm064458.htm.
11 Ibid. On September 2, 2008, FDA asked for public comments and scientific data to assist it in improving its 1998
guidance.
12 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.
13 “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.
14 FDA’s website, Produce and Plant Products Guidance for Industry, http://www.fda.gov/Food/GuidanceCompliance
RegulatoryInformation/GuidanceDocuments/ProduceandPlanProducts/default.htm.
15 “USDA and FDA Coordinating Efforts to Ensure Safety of Produce: FDA Invites Public Comments to Inform Future
Rulemaking,” February 18, 2010, 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.
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In another recent instance of on-farm regulatory activity, the FDA on July 9, 2009, published a
final rule to require shell egg producers to implement specific safety measures to prevent on-farm
contamination of eggs by Salmonella Enteritidis (SE).16 The 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.17 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.18 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 July 9,
2012, to comply. FDA published a guidance document on April 13, 2010, to help small producers
comply with the new rule.19
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.20
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
16 74 Federal Register 21928-21929.
17 74 Federal Register 33030-33101. As already noted, since May 2010, a large-scale recall of more than 550 million
shell eggs has been linked to concerns about a nationwide increase of SE infections.
18 “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.
19 Guidance for Industry: Prevention of Salmonella Enteritidis in Shell Eggs During Production, Transportation, and
Storage; Small Entity Compliance Guide, April 2010, http://www.fda.gov/Food/GuidanceComplianceRegulatory
Information/GuidanceDocuments/SmallBusinessesSmallEntityComplianceGuides/ucm207507.htm.
20 Ensuring Safe Food from Production to Consumption, National Academies Press, Washington, D.C., 1998.
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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.21
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.22
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.”23
21 FDA’s website: http://www.fda.gov/cvm/bsetoc.html.
22 See CRS Report RL31921, Pesticide Law: A Summary of the Statutes.
23 FDA Science Board, FDA Science and Mission at Risk: Report of the Subcommittee on Science and Technology,
November 2007.
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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.
Under another program, USDA is proposing a new approach that will allow individual states (and
tribal nations) to chose their own degree of within-state animal identification (ID) and traceability
for livestock populations. This voluntary program is intended to improve the ability to pinpoint
and control animal diseases.24 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.)
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.25 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.26
Leafy Greens Marketing Agreement
In October 2007, AMS invited comments on whether to create a federal marketing program that
specifically would commit handlers (packers, processors, shippers) of leafy greens, including
24 For more information, see CRS Report R40832, Animal Identification and Traceability: Overview and Issues.
25 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,
http://agriculture.house.gov/testimony/111/h051409/Shipman.pdf. Detailed information is available at the AMS
website, http://www.ams.usda.gov.
26 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.
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lettuce and spinach, to meet prescribed safety standards.27 In June 2009, a group of agricultural
associations formally requested that AMS begin the steps toward establishment of a national
marketing agreement for leafy greens.28 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.29 Reportedly, California and Arizona represent
approximately 90% of leafy greens production, and a national agreement would seek to cover the
nation’s remaining 10%.30
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.31 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.32
Currently, the USDA (AMS) role in a national agreement is to publish a notification regarding the
request and to conduct public hearings. In fall 2009, USDA held public hearings on a proposed
marketing agreement covering leafy green vegetables and products under the Agricultural
Marketing Agreement Act.33 If adopted, 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
27 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).
28 See, for example, letter from various produce groups to USDA’s AMS Administrator Rayne Pegg, July 31, 2009,
http://www.ams.usda.gov/AMSv1.0/getfile?dDocName=STELPRDC5081064.
29 California Leafy Green Products Handler Marketing Agreement website, http://www.caleafygreens.ca.gov/.
30 “Produce industry petitions USDA for leafy greens marketing agreement,” Food Chemical News, June 15, 2009.
31 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.
32 National Leafy Greens Marketing Agreement, “Frequently Asked Questions,” http://www.nlgma.org/faqs.php. 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.
33 74 Federal Register, 45565-45574, September 3, 2009, http://www.gpo.gov/fdsys/pkg/FR-2009-09-03/pdf/E9-
21295.pdf. Information on the hearings is at AMS website.
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initiate an agreement. In March 2010, FDA announced that it would issue a proposed rule to
establish safety standards for the production and packing of fresh produce by the end of 2010.34
Many produce groups supporting the establishment of a national marketing agreement further
want Congress to consider viewing the LGMA as ”an instructive example for how to proceed”
with the development of new food safety rules and regulations.35
Legislative Action
Food Safety Bill Overview
In the 111th Congress, a number of bills seeking to regulate agricultural producers directly were
introduced. These 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 focused 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.”
Comprehensive food safety bills have progressed in both the House and the Senate and could
affect farmers and ranchers. In the House, H.R. 2749 became the main legislative vehicle for food
safety changes. It was amended and approved by the Energy and Commerce Committee on June
17, 2009, and was passed by the full House on July 30, 2009.
In the Senate, S. 510 was modified and approved by the Senate Health, Education, Labor, and
Pensions (HELP) Committee and reported in late 2009. In August 2010, a group of Senate leaders
released a manager’s amendment to S. 510. However, Senate floor action continued to be held up
by objections about the projected cost of the bill, as well as continued attempts to further amend
it. In November 2010, the Senate resumed consideration of its bill and a second substitute
amendment to S. 510 (S.Amdt. 4715) was offered. This substitute amendment to S. 510 passed
the Senate on November 30, 2010. Following passage of the Senate bill, however, it was reported
that the House may block the Senate bill using a procedure known as “blue-slipping,” because the
bill contains fees that might be subject to certain tax origination provisions. (For more details, see
CRS Report R40443, Food Safety in the 111th Congress: H.R. 2749 and S. 510)
The House and Senate food safety proposals 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,
among other provisions. Several of these requirements could potentially affect small farms and
food processors. For example, H.R. 2749 would require the establishment of new standards for
34 FDA, “Preventive Controls for Fresh Produce” (FDA-2010-N-0085), March 12, 2009, http://www.fda.gov/Food/
FoodSafety/ Product-SpecificInformation/FruitsVegetablesJuices/FDAProduceSafetyActivities/ucm202945.htm.
35 Comments to FDA on preventive controls for fresh produce safety (Docket No. FDA-2010-N-0085) from Scott
Horsfall and the Leafy Green Products Handler Marketing Agreement, July 23, 2010.
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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. Provisions in the Senate food
safety proposal—including a section requiring produce safety standards—also would affect on-
farm production.
As both bills have progressed, Congress has continued to modify provisions to address the
potential effects of the proposed food safety requirements on small farms and food processors, as
well as organic, direct-to-market, and sustainable farming operations. For example, although the
Energy and Commerce Committee amended and approved H.R. 2749 to address small-farm
concerns, the version passed by the full House in June 2010 contained additional changes
addressing agricultural interests. Similarly, the version of S. 510 reported by the Senate Health,
Education, Labor, and Pensions Committee in December 2009 was further modified to address
small-farm concerns as part of a substitute manager’s amendment agreed to by Senate leaders that
was released in August 2010. Despite these changes, some farm groups are continuing to push for
additional changes to further address these concerns. Additional changes were made to address
small farm concerns again in a second substitute amendment to S. 510 (S.Amdt. 4715) that was
offered and passed off the floor in November 2010. Further action on the legislation remains
pending for various procedural reasons.
Following a brief overview of farm interest concerns with the pending food safety bills, this
report focuses on selected provisions in the House-passed bill (H.R. 2749) and the Senate-passed
bill (S. 510) that could affect farming operations. The current versions of these proposals reflect
compromises with farm interests to address the treatment of farms.
Farm Interest Concerns with Food Safety Bills
House Debate
Concerns among farm and rural groups about the potential effects of new food safety
requirements on farms and food processors surfaced early in the debate. Most vocal were small
farms and food processors; organizations representing small, organic, direct-to-market, and
sustainable farming operations; and also small livestock operations. In part, the concerns arose in
the wake of videos and emails circulated on the Internet asserting that the proposed food safety
bills would undermine or even destroy the nation’s small and organic farms, to the benefit of
industrialized agriculture.36 In fact, none of the original bills’ farm-related provisions appeared to
explicitly exempt such operations, other than directing that the needs of small businesses be
considered during implementation. Some groups, such as the Organic Consumers Association
(OCA) and La Vida Locavore, sought on the one hand to challenge what they viewed as the
“hysteria” and unsubstantiated facts that were circulating (about H.R. 875 in particular), and on
the other hand to criticize sharply the bill’s language.37 Most concerns centered on potential
ambiguity in the definition of a “food production facility” and fears that organic producers as well
36 See, for example, http://www.youtube.com/watch?v=eDl6RjYaOt4 (video) and articles; http://educate-yourself.org/
cn/HR875andS425organicfarmingban13mar09.shtml.
37 See, for example, OCA, “H.R. 2749 The Food Safety Enhancement Act,” Action Alert, http://capwiz.com/
grassrootsnetroots/issues/alert/?alertid=13799941; and Jane Richardson, “HR 875 Rumors Will Destroy Our
Credibility,” March 23, 2009, http://www.lavidalocavore.org/showDiary.do?diaryId=1266.
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as “individuals beyond large farms (i.e., backyard gardeners) could be penalized and subject to
review by the government.”38
In a posting on her own website, Representative DeLauro sought to challenge the “myths” about
her bill, H.R. 875, arguing that its focus was to ensure the safety of food in interstate commerce,
not to regulate or penalize backyard gardens or farmers markets. She also asserted it would not
interfere with organic farming, and had the support of major consumer and food safety groups.39
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.”40 At a conference in early April 2009, Carol Tucker
Foreman, of Consumer Federation of America’s Food Policy Institute, agreed that Congress might
want to consider tailoring some requirements based on different types of operations or phasing in
requirements for some operations. Foreman suggested, for example, possibly exempting direct-to-
market farms (e.g., those serving farmers markets).41
Around this time, H.R. 2749 had overtaken the DeLauro bill (H.R. 875) as the House food safety
vehicle, and it had been altered several times in response to criticisms by agricultural interests.
H.R. 2749 was modified during committee action to exempt direct-to-market farms from some of
the new traceability provisions. However, some small farm advocates have 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, there were concerns that the
requirements could 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 appeared to create a regulatory framework that would heavily burden small farms and
local food processors, which some claim are “the very people who provide a safe, healthy
alternative to the industrial food supply.”42
One mainstream agricultural publication observed, “small 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.).”43
As 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. For example, in separate letters to the
38 Alexandra Gross, “Food Fight: The Food Safety Bill Is Cause for Concern, Not Panic,” E Magazine, March/April
2009, http://www.emagazine.com/view/?4629&src=QSA062.
39 “Myths and Facts, H.R. 875—The Food Safety Modernization Act,” http://delauro.house.gov/files/
HR875_Myths_Facts1.pdf.
40 Food & Water Watch, “Background on H.R. 875,” http://www.foodandwaterwatch.org/food/foodsafety/background-
on-h-r-875?searchterm=h.r.+875.
41 Remarks at the Farm Foundation Forum, “The Future of Food Safety Regulation,” available by audio link at
http://www.farmfoundation.org/news/articlefiles/363-20090407_pv_farm_foundation.mp3.
42 Farm-to-Consumer Legal Defense Fund, “H.R. 2749’s Real Impacts: a Response to Consumers’ Union,”
http://www.farmtoconsumer.org/HR2749-response.htm.
43 Gary Blumenthal, “Policy Roundup,” World Perspectives, March 11, 2009.
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House Energy and Commerce Committee and the House Agriculture Committee, a group of
agriculture interests asserted that H.R. 2749 would create new on-farm regulatory authorities that
would be redundant with USDA oversight.44 They argued that such new requirements could affect
agricultural practices that the FDA neither has 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. This, they argued, would violate U.S. trade commitments, inviting retaliation by
trading partners against U.S. agricultural exports.
The House-passed bill contains additional provisions that are intended to address potential effects
of the food safety requirements on small, organic, direct-to-market, and sustainable farming
operations, among other related provisions. For example, H.R. 2749 would exempt from the
facility registration requirements most commodity producers that sell directly to consumers,
including an “operation that sells food directly to consumers if the annual monetary value of sales
of the food products from the farm or by an agent of the farm to consumers exceeds the annual
monetary value of sales of the food products to all other buyers” (Section 101(b)(1)). H.R. 2749
also would require that any regulations governing performance standards “take into consideration,
consistent with ensuring enforceable public health protection, the impact on small-scale and
diversified farms, and on wildlife habitat, conservation practices, watershed-protection efforts,
and organic production methods” (Section 104(b)).
Senate Debate
Following passage of the House bill, and modifications to address farm interest concerns with
H.R. 2749, agriculture groups continued to urge Congress to mitigate any potential effects of the
food safety requirements on small, organic, direct-to-market, and sustainable farming operations.
S. 510 was first modified by the Senate HELP Committee to require that the HHS Secretary
“provide sufficient flexibility to be applicable to various types of entities engaged in the
production and harvesting of raw agricultural commodities, including small businesses and
entities that sell directly to consumers, and be appropriate to the scale and diversity of the
production and harvesting of such commodities” (Sections 103 and 105, among others). Other
committee modifications required consideration of federal conservation and environmental
standards and policies including wildlife conservation, and assurances that these provisions will
not conflict with or duplicate those of the national Organic Foods Production Act (Section 105).
These provisions were retained in the Senate’s August 2010 manager’s amendment to S. 510.
The Senate manager’s amendment of August 2010 included additional modifications to address
the potential effects of the food safety requirements on small businesses and other farming
operations. These included allowances for HHS to exempt or limit compliance requirements for
certain types of farming operations and food processors, along with provisions that would allow
the HHS Secretary the discretion to exclude certain operations, if it is determined that these are
low risk and/or do not present a risk of “serious adverse health consequences or death.” Also
included were assurances that any new regulations would not conflict with or duplicate other
federal policies and standards, and that they would minimize regulatory burden and unnecessary
44 The June 26, 2009, letters were signed by the American Farm Bureau Federation and several other commodity
associations such as the National Association of Wheat Growers and the National Milk Producers Federation
(http://www.ncga.com/files/pdf/foodsafety-ecc090625.pdf; http://www.ncga.com/files/pdf/foodsafety-ag09.0625.pdf).
Farm-related concerns also were explored at a July 16, 2009, hearing before the House Agriculture Committee.
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paperwork and the number of separate standards imposed on the facility (for example, the
registration, HACCP, produce standards, and traceability requirements in Sections 101, 103, 105,
and 204). In addition, HHS would be required to publish “small entity compliance policy guides”
to assist small entities in complying with some proposed requirements, such as those regarding
registration, HACCP, produce standards, and traceability. Implementation would be delayed for
small and very small businesses (as defined by the Secretary) for the HACCP and produce
standards requirements, and there would be assurances of “sufficient flexibility” for producers,
including small businesses and entities that sell directly to consumers, for the HACCP, produce
standards, and traceability provisions.
Despite these additional modifications, Senator Jon Tester continued to push for further
amendments to address small farm interests. Senator Tester had first announced in spring 2010
that he planned to introduce two amendments to the Senate committee-reported bill, S. 510.45
Under one amendment, certain commodity producers would face limited traceback and record-
keeping requirements if the “average annual adjusted gross income [AGI] of such facility for the
previous 3-year period is less than $500,000”; another amendment would have exempted
producers who sell directly to market if “the annual value of sales of food directly to consumers,
hotels, restaurants, or institutions exceeds the annual value of sales of food to all other buyers.”46
These amendments were not included in the Senate manager’s amendment of August 2010.
In September 2010, Senator Tester, along with Senator Kay Hagan, announced an updated version
of this amendment.47 The modified Tester-Hagan amendment would establish “modified
requirements for qualified facilities” for so-called “very small” businesses, among other
provisions for both small and very small businesses (to be defined by HHS in regulation). Under
this proposed amendment, certain qualified facilities would not be subject to certain food safety
requirements; instead they would be required to submit to HHS relevant documentation showing
that they have implemented preventive food safety controls and evidence that they are in
compliance with state, local, county, or other applicable non-federal food safety laws, among
other documentation. Such modified requirements would apply to producers considered “very
small” and would include operations that have annual sales of less than $500,000 (defined not as
AGI, but as the three-year average “annual monetary value of sales,” adjusted for inflation) and
whose value of sales directly to “qualified end-users” exceeds all other sales. Qualified end-users
would include consumers or a restaurant or retail food establishment that is located in the same
state or less than 400 miles48 from the qualified facility, or that is buying food for sale directly to
consumers. Implementation deadlines would also be delayed for small and very small businesses,
following promulgation of any applicable regulations under the newly enacted law. The provision
also would require that HHS conduct a study of the food processing sector, in conjunction with
USDA.
45 Senator Tester press release, “Tester to Introduce ‘Common Sense’ Amendments to Food Safety Bill,” April 14,
2010, http://tester.senate.gov/Newsroom/pr_041410_foodsafety.cfm (bill language is posted at website).
46 Ibid.
47 Press release, Senator Tester, “Updated Food Safety Amendment Protects Small Producers,” September 24, 2010,
http://tester.senate.gov/Newsroom/pr_092410_foodsafety.cfm. Bill language is available at http://tester.senate.gov/
Legislation/upload/Tester-Food-Safety-Amendment.pdf.
48 The 400-mile designation is similar to the distance specified in a provision of the Food, Conservation, and Energy
Act of 2008 (P.L. 110-246, Section 6015). That provision defines a “Locally or Regionally Produced Agricultural Food
Product” as any agricultural food product that is grown, produced, and distributed near where it is marketed such that
“the total distance that the product is transported is less than 400 miles from the origin of the product.”
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During the Senate floor debate in November 2010, a modified version of this amendment was
adopted as part of the substitute Senate amendment (S.Amdt. 4715) to S. 510. This version was
passed off the Senate floor on November 30, 2010. Consequently, the Senate-passed bill would
exempt certain food processing operations from the proposed HACCP requirements and also
would exempt certain farms from the new produce standards. Food facilities would qualify for an
exemption from the HACCP requirements under § 103 if they are either a “very small business”
as defined by FDA in rulemaking, or if the facility’s “average annual monetary value” of all food
sold during the previous three year period was less than $500,000, provided that the food is sold
directly to “qualified end users” such as consumers, restaurants, or retail food establishments
located in the same state where the facility sold the food or within 275 miles of the facility. Such
a facility would need to demonstrate that it either has “identified potential hazards associated with
the food being produced,” and is implementing and monitoring these preventive controls, or that
it is “in compliance with State, local, county, or other applicable non-Federal food safety law.”
Foods produced from such a facility would also need to provide the facility’s name and address
on a food packaging label or at the point of purchase.
Farms that would be exempt from the produce standards under § 105 also include those with a
three-year average monetary value of the food they sold of less than $500,000, provided that the
food is sold directly to the similarly defined “qualified end users” and if the farm provides similar
notification to consumers. The exemption for both facilities and farms may be revoked in the
event that a foodborne illness outbreak is directly linked to an exempted facility or farm, or based
on a determination by the HHS Secretary.
Throughout this debate, many farm groups have expressed support for the Tester-Hagan
amendment.49 However, one of the leading produce industry groups, United Fresh Produce
Association (UFPA), opposed the amendment and urged the Senate not to add “exemptions based
on the size of the operation, production practices, or geographic location for food being sold in
the commercial market” to its food safety proposal.50 In November during the floor debate, a
letter circulated from UFPA and 19 other producer associations again urging the Senate not to
adopt the amendment.51 In addition to broader industry concerns about the need to preserve
consumer confidence in the safety of all marketed produce, another industry concern is whether
small foreign producers might also be exempt, if small U.S. producers were to be exempt (given
prevailing U.S. equivalency standards).52
Meanwhile, some public health and consumer groups expressed concern that the Tester-Hagan
amendment would create “too great a loophole” in the food safety requirements, among other
49 See, for example, letter from more than 100 farm groups under the Small Holder Alliance, “Support Fresh, Safe
Local Food in the Food Safety Bill,” April 15, 2010, http://smallholdersalliance.com/Amend-S510-April-
15%20(2).pdf; and articles in Food Safety News (http://www.foodsafetynews.com/) by Helena Bottemiller, “Tester
Amendment Picks Up Cosponsor,” May 3, 2010, and “Farmers Gain in Senate Food Safety Battle,” April 15, 2010.
50 United Fresh Produce Association, 2010 Issues Brief, http://www.unitedfresh.org/assets/
Issue_Brief_United_Fresh_Produce_Association_2010.pdf.
51 Letter to Senators Reid, McConnell, Harkin, and Enzi from United Fresh Produce Association, Produce Marketing
Association, Northwest Horticultural Council, and other national and state groups, November 18, 2010, available at
http://www.unitedfresh.org/.
52 Ibid., comments by industry representatives at the UFPA’s 2010 Washington Public Policy Conference, September
15, 2010; and Helena Bottemiller, “Group Breaks Ranks on Small Farm Exemptions,” Food Safety News, September
10, 2010.
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concerns.53 In October 2010, a coalition of these groups expressed its opposition to the modified
version of the Tester-Hagan amendment.54 The groups cited concern that the exemption was
based only on sales volume and could result in certain high-risk foods being exempted from food
safety protections, and concern about whether labeling requirements were needed for such foods.
They argued that it is unclear how many facilities would be exempted under the proposed sales
threshold, and that FDA should conduct market analyses to determine appropriate thresholds for
exemption in both the produce and processed food sectors. They also questioned the
appropriateness of the then 400-mile designation and other aspects of what would constitute a
“direct sale” under the proposed amendment, such as whether grocery stores and restaurants
should be included.
Mitigating Effects on Small Business and Farming Operations
Concerns among farm and rural groups about the potential effects of new food safety
requirements on farms and food processors surfaced early in the debate over how to reform U.S.
food safety laws. Most vocal were small farms and processors; organizations representing small,
organic, direct-to-market, and sustainable farming operations; and small livestock operations.55 At
issue is whether numerous proposed requirements would be more costly and burdensome to small
farms and other small businesses than could be justified by the potential public health protections
such requirements are intended to provide.
Considerations for small business could take many forms, including waiving certain
requirements, providing additional time for compliance, providing grants and/or technical
assistance to aid in compliance, and exempting certain types of businesses from meeting the
requirements. Currently the FFDCA exempts some types of businesses from certain food safety
requirements. For example, farms, restaurants, other retail food establishments, and certain
nonprofit food establishments and fishing vessels are exempt from facility registration
requirements under FFDCA § 415.
Various approaches might be used to define whether a farm or food processor is a “small”
business. Often, a definition may be based on a particular threshold value for a financial or
business measure, such as annual income or value of sales, numbers of employees, or other
measures.
With respect to farming operations, USDA typically relies on measures of gross cash income as a
measure of the size of a farm business. Gross cash income refers to the sum of all receipts from
the sale of crops, livestock, and farm-related goods and services, including any direct payments
from the government. For purposes of classifying farms, USDA defines a “small commercial
farm” as an operation with gross cash income of $10,000 to less than $250,000 annually; “large
farms” are defined as farms with gross cash income of $250,000 to less than $1 million.56 USDA
53 Letter to Senator Tester from the Consumers Union regarding Amendments to S. 510, the FDA Food Safety
Modernization Act, April 20, 2010, http://www.consumersunion.org/campaigns//notinmyfood/016345indiv.html; and
articles in Food Safety News (http://www.foodsafetynews.com/); Helena Bottemiller, “Public Health Opposition to
Tester Amendment,” April 28, 2010; Helena Bottemiller, “Farmers Gain in Senate Food Safety Battle,” April 15, 2010;
and Alex Ferguson, “What’s Wrong with the Tester Amendments,” May 4, 2010.
54 Make Our Food Safe coalition, October 19, 2010, http://www.makeourfoodsafe.org/. The coalition’s white paper on
the Tester-Hagan amendment is at https://ssl.capwiz.com/pew/attachments/TesterResponsefactsheetfinal.pdf.
55 See CRS Report RL34612, Food Safety on the Farm: Federal Programs and Legislative Action.
56 Hoppe, R.A., “U.S. Farm Structure: Declining—But Persistent—Small Commercial Farms,” Amber Waves, USDA,
(continued...)
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defines farms with gross cash income of less than $10,000 annually as very small, non-
commercial farms. Under these definitions, USDA data indicate that about one-third of all crop
and livestock producers are considered “small commercial” farms (Table 1). The share of small
commercial farms will vary depending on commodity. For example, among fruit and vegetable
producers who might be affected by requirements under the House and Senate food safety
measures, the share of small commercial farms is roughly 10% of all growers in this category.57
The size threshold used and the type of income counted to define a small business varies in
legislation and by agency. For example, the Small Business Administration (SBA) has set
different thresholds for defining a small business that vary considerably from USDA: among
most crop and livestock producers, SBA defines as a small business those who make no more
than $750,000 in sales per year.58 In some cases, however, USDA uses SBA’s definition for
defining a small business. Specifically, SBA’s threshold of $750,000 in annual sales is used by
USDA to determine small and very small meat and poultry plants as part of FSIS’s outreach and
oversight activities under its HACCP implementation and laboratory testing programs.59 Under
SBA’s business size standards, more facilities would be considered small businesses, with up to
one-half of all commercial crop and livestock producers defined as small.60
Elsewhere in farm legislation, such as in the periodic omnibus farm bill,61 adjusted gross income
(AGI) is an alternative income measure that is generally used to differentiate farm size. AGI is a
common measure of income for tax purposes, combining income from all sources. Business
income contributes to AGI on a net basis, that is, after business expenses. Thus, it is comparable
to profit: sales minus expenses and also taxable deductions. In the farm bill, an AGI limit is used
to differentiate wealthier farm households as a means test for the maximum amount of income
that an individual can earn and still remain eligible for commodity program benefits, including
any direct payments from the government. The 2008 farm bill tightened these limits by reducing
the AGI limit to $500,000 of non-farm AGI and $750,000 of farm AGI.62 Given that most
business information is proprietary, data are limited on the share of commodity producers (farms
and food processors) that have an annual AGI of less than $500,000. Information for U.S. farms
indicates that farms with less than $500,000 AGI account for more than 95% of all farms.63
(...continued)
September 2010; and Hoppe, R.A., Small Farms in the United States: Persistence Under Pressure, EIB-63, USDA,
February 2010. Based on 2007 survey data.
57 Ibid., Figure 3.
58 Small Business Size Regulations, Title 13 C.F.R. Part 121.
59 Correspondence between CRS personnel and askFSIS (http://www.fsis.usda.gov/).
60 Based on data on farms that make up to $1 million. USDA survey data are not published for farms that generate
between $500,000 and $750,000 in annual sales.
61 The most recent farm bill was the Food, Conservation, and Energy Act of 2008, P.L. 110-246. For more information,
see CRS Report RL34594, Farm Commodity Programs in the 2008 Farm Bill.
62 Ibid.
63 The White House, “Strengthening the Rural Economy—Improving America’s Support of Agriculture,”
http://www.whitehouse.gov/administration/eop/cea/factsheets-reports/strengthening-the-rural-economy/improving-
americas-support-of-agriculture. Based on USDA data from the 2007 Department of Agriculture’s Agricultural
Resource Management Survey: http://www.ers.usda.gov/Briefing/FarmIncome/govtpaybyfarmtype.htm.
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Table 1. U.S. Farms and Food Manufacturers, 2007
(by size based on average annual sales receipts)
Farms and Food Manufacturing Establishments
Number
Percent
All Farms, Total
2,204,792
100.0%
Less than $10,000 (defined by USDA as “very small, non-commercial” farms)
1,271,735 57.7%
Between $10,000-$249,000 (defined by USDA as “smal commercial” farms)
715,947
32.5%
Between $250,000-$499,000
96,251
4.4%
More than $500,000
120,859
5.5%
All Food Manufacturing, Totala
Total, All Food Manufacturers
25,796 100.0%
Less than $500,000
8,906
34.5%
Selected Food Manufacturing Sectorsb
Grain and Oilseed Milling, Total 830
100.0%
Less than $500,000
71
8.6%
Fruit/Vegetable Manufacturing, Total
1,668
100.0%
Less than $500,000
203
12.2%
Dairy Product Manufacturing, Total
1,612
100.0%
Less than $500,000
174
10.8%
Animal Slaughtering and Processing, Total
3,817
100.0%
Less than $500,000
784
20.5%
Seafood Preparation/Packaging, Total
685
100.0%
Less than $500,000
114
16.6%
Bakeries/Tortilla Manufacturing, Total
10,269
100.0%
Less than $500,000
5,835
56.8%
Other Food Manufacturing, Total
3,310
100.0%
Less than $500,000
671
20.3%
Source: Data for farms are from USDA, 2007 Census of Agriculture, Table 58, December 2009. Data for
manufacturing establishments are from the U.S. Census Bureau’s 2007 County Business Patterns based on annual
survey data for al food manufacturers on the number of establishments by “enterprise receipt size,”
http://www.census.gov/econ/susb/.
Notes: “Average annual sales” includes market value of agricultural products sold and government payments.
Farm size designations are those described by USDA in Small Farms in the United States: Persistence Under Pressure,
EIB-63, February 2010, http://www.ers.usda.gov/publications/eib63/. For manufacturing, industry classification is
based on 2002 North American Industry Classification System (NAICS) codes.
a. Included in this total, but not shown separately are data for sugar and confectionery and animal food
manufacturing.
b. Ranked in order by NAICS code but including sugar and confectionery and animal food manufacturing.
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Data are not available indicating what share of all farms also engage in food processing. Such
operations might include fruit and vegetable producers that pack or further process the produce
they grow by making products such as jams, jellies, or juices, or other processed fruit and
vegetable products; other examples might include dairies that are also producer-handlers that
bottle their own milk. Also, only limited data are available that generally characterize the market
and producer channels for so-called locally or sustainably produced foods, or other direct-to-
market foods.64
For food processors and manufacturers, often different business measures are used to define small
businesses. SBA definitions of small food processors are based on the number of employees at a
business. Given that most farms do not employ large numbers of workers, size standards based on
the number of employees are generally not applicable to farming operations. Among most food
processors, a small business is defined by the SBA as a business with no more than 500
employees.65 By this definition, nearly all (97%) of all food processors would be considered small
businesses based on U.S. Census Bureau data.66 The U.S. Census Bureau also tabulates data for
manufacturing facilities based on annual sales receipts (Table 1).
FDA regulations also define certain small food processing businesses, but they are case by case
and not inclusive. For example, FDA’s current HACCP regulations exempt “small” juice
processors as those “employing fewer than 500 persons.”67 Accordingly, available data indicate
that as many as 84% of businesses that make juice are not covered by the HACCP requirements.68
Very small businesses are also exempt, and so defined by FDA if they meet one of the following
three criteria: “annual sales of less than $500,000, total annual sales greater than $500,000 but
total food sales less than $50,000, or operations that employ fewer than an average of 100 full-
time equivalent employees and sell fewer than 100,000 units of juice in the United States.”69
Available data indicate that about 12% of all fruit and vegetable manufacturers have annual sales
less than $500,000 (Table 1). Producers of “raw agricultural ingredients of juice,” such as fruit
and vegetable growers, are not covered by the HACCP requirements.
Treatment of Farms in the House and Senate Food Safety Bills
The provisions in the House-passed bill and Senate amendment that could have the most direct
effect on on-farm activity, especially produce growers, will be the establishment of new standards
for produce safety. In H.R. 2749, Section 104 will require that producers follow new rules for the
growing, harvesting, processing, packing, sorting, transporting, and holding of certain types of
raw agricultural commodities, covering fruits, vegetables, nuts, and fungi. In the Senate
amendment, Section 105 will require that producers follow new minimum standards for the safe
production and harvesting of those types of fruits and vegetables that are raw agricultural
commodities.
64 See for example Martinez, S. et al., Local Food Systems, Concepts, Impacts, and Issues, ERR-97, USDA, May 2010,
http://www.ers.usda.gov/Publications/ERR97/ERR97.pdf; and Hoppe, R.A. et al., Small Farms in the United States,
Persistence Under Pressure, EIB-63, USDA, February 2010, http://www.ers.usda.gov/Publications/EIB63/EIB63.pdf.
65 Small Business Size Regulations, Title 13 C.F.R. Part 121.
66 Based on annual survey data for all food manufacturers on the number of firms broken out by employment size of the
enterprise. U.S. Census Bureau, 2007 County Business Patterns, http://www.census.gov/econ/susb/.
67 Hazard Analysis And Critical Control Point (HACCP) Systems, Title 21 C.F.R. Part 120.
68 U.S. Census Bureau, 2007 County Business Pattern. Data for “Frozen Fruit, Juice, and Vegetable Manufacturing.”
69 Hazard Analysis And Critical Control Point (HACCP) Systems, Title 21 C.F.R. Part 120.
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These provisions, among other provisions in H.R. 2749 and the Senate amendment to S. 510,
could potentially affect agricultural producers:
• new on-farm safety standards, especially for produce (Section 104 of H.R. 2749;
Section 105 of S. 510);
• facility registration requirements (Section 101 of H.R. 2749; Section 102 of S.
510);
• records access and/or inspection requirements (Section 106 of H.R. 2749;
Sections 101 and 204 of S. 510);
• food traceability requirements (Section 107 of H.R. 2749; Section 204 of S. 510);
• hazard analysis and risk-based preventive controls (Section 103 of S. 510);
• targeting of inspection resources (Section 201 of S. 510); and
• changes in the reportable food registry (Section 112 of H.R. 2749).
Following is a more detailed discussion of these provisions.
Although both the House- and Senate-passed bills contain requirements that might affect small
business and farming operations, both bills also seek to take into account the needs of small
businesses and provide for coordination of enforcement and education activities with others such
as USDA and state authorities.
The full extent to which these other provisions might actually affect small business and farming
operations remains unclear, since the specific business requirements under these provisions would
be subject to agency rulemaking, as well as the discretion of the HHS Secretary. It is not possible
to estimate what share of all food processing operations might be exempt from the proposed
HACCP requirements, how many farms might be exempt from the new produce standards, or
how other small business considerations might possibly mitigate the effects of these and other
requirements in the proposal. In part, this is because the definition of small and very small
business would be determined by HHS in future agency rulemaking and subject to other
requirements specified in the measures. Even though farms would continue to be exempt from the
proposed facility registration requirements, there are farms that also engage in food processing
that might be affected. Data are not available to determine what share of farms also engage in
food processing. In addition, other stipulations in S. 510 would require that foods be sold locally
and to certain qualified end-users. Data are also not available to determine what share of grower-
processors might qualify for such an exemption; such a determination would likely be made on a
case-by-case basis.
H.R. 2749 (House-Passed)
Safety Standards for Produce and Certain Other Raw Agricultural Commodities
Section 104 of H.R. 2749 creates a new § 419A of the FFDCA, requiring the HHS Secretary to
publish 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. This provision was modified from the
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committee-approved bill version, which 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 similarly determined that such standards are
reasonably necessary. In other words, the House-passed bill limits these standards to a fruit,
vegetable, nut, or fungus. It requires a notice of proposed rulemaking within 18 months of
enactment, and final rules within three years afterwards.
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. H.R.
2749 also would require the Secretary to update the 1998 FDA guidance for minimizing hazards
in fresh fruits and vegetables.
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
Facility Registration Requirements
Section 101 of the House-passed version of H.R. 2749 amends FFDCA § 415 to require facilities
to register annually, by each December 31, and to pay an annual registration fee of $500. As
approved by the committee, the bill does not require farms (or retail food establishments) to begin
registering and incur the $500 annual fee. To clarify this continuing exemption, the House-passed
bill adds 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 feedstuffs
grown there and only distributed directly to another farm for its consumption there.
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Records Access
Section 106 of H.R. 2749 amends FFDCA § 414(a) regarding records inspection and access. The
committee-approved bill, while broadening the HHS Secretary’s authority to access records,
would also have subjected farms to such records access (and record-keeping) provisions. The
House-passed 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. Relevant
records (i.e., for access and copying) are to be all those “relating to such article bearing on
whether the food is adulterated, misbranded, or otherwise in violation of this Act,” rather than the
higher current threshold—which is those records “needed to assist the Secretary in determining
whether a food is adulterated and presents a threat of serious adverse health consequences.”
Food Traceability
Section 107 of H.R. 2749 amends FFDCA § 414 to require the Secretary to establish by
regulation a tracing system for food in, or to be imported into, the United States. The committee-
approved bill required 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 two business days.” This also would
entail new record-keeping requirements for those in each segment of the food industry. The
committee bill exempted 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 six 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).
Reportable Food Registry
The Administration is currently 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. Section 112 of
H.R. 2749 expands coverage to farms where food is produced for sale or distribution in interstate
commerce, to restaurants and other retail food establishments, and to those required by this bill to
register as importers. Under a change in the final House bill, farms (and restaurants and retail
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food establishments) that are unable to provide such information through a new electronic portal
must be given an alternative means for reporting.
Other Farm-Related Modifications
Section 5 of H.R. 2749 specifically exempts from the proposed requirements 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 House-passed
bill added language to ensure that the animals themselves are also exempt and that USA-
approved, state-inspected meat and poultry facilities are exempt as well.
S. 510 (Senate-Passed)
Standards for Produce Safety
Section 105 of S. 510 establishes a new FFDCA § 419, regarding safety standards for produce. It
would require within one year—in consultation with USDA and state agriculture departments
(including with regard to the national organic foods program), and in consultation with the
Department of Homeland Security—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.” S. 510 provides that any proposed rules 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.”
S. 510 also provides that proposed rulemaking shall “provide sufficient flexibility to be applicable
to various types of entities … including small businesses and entities that sell directly to
consumers and be appropriate to the scale and diversity” of production and harvesting, as well as
take into consideration, consistent with public health protection, “conservation and environmental
practice standards and policies established by Federal natural resource conservation, wildlife
conservation, and environmental agencies.” It also requires that for certified organic production,
the rules shall “not include any requirements that conflict with or duplicate the requirements of”
the national organic foods program, while providing the same level of protection as required
under this act. Priority is to be given to those raw fruits and vegetables that have been associated
with foodborne illness outbreaks. The bill also includes provisions for public input, timelines for
implementation of rules, and a system for granting variances for states and foreign governments.
S. 510 contains provisions for consideration of small businesses. As noted above, small and very
small businesses may be exempted from regulation if the Secretary has determined these “are low
risk and do not present a risk of serious adverse health consequences or death.” In addition, there
are extended implementation deadlines for small and very small businesses: small businesses (as
defined by the Secretary) are given one year after final regulations are promulgated, and very
small businesses (as defined by the Secretary) two years after final regulations. In addition, the
HHS Secretary is required to issue a ”small entity compliance policy guide” to assist small
entities in complying with the registration requirements and other activities (no later than 180
days after the issuance of the regulations under this section). The Secretary must also ensure that
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any updated guidance complies with the Paperwork Reduction Act (PRA) and minimizes
regulatory burden and unnecessary paperwork and the number of separate standards on the
facility, among other clarifications regarding acknowledgment of risk differences and compliance
burden.
During the Senate floor debate in November 2010, a substitute Senate amendment (S.Amdt.
4715) to S. 510 was offered and ultimately passed off the Senate floor. The Senate-passed bill
would further exempt certain farms from the new produce standards. Farms that would be exempt
from the produce standards under Section 105 also include those with a three-year average
monetary value of the food they sold of less than $500,000, provided that the food is sold directly
to the similarly defined “qualified end users” and if the farm provides similar notification to
consumers. The exemption for both facilities and farms may be revoked in the event that a
foodborne illness outbreak is directly linked to an exempted facility or farm, or based on a
determination by the HHS Secretary. For more information see discussion under “Senate Debate.”
Inspection of Records
Section 101 of S. 510 amends FFDCA § 414 and modifies 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 this provision, at least directly.70 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
Section 102 of S. 510 amends FFDCA § 415 to require biennial facility registration, with an
abbreviated process for registrants whose information has not changed. It 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). The Senate-passed bill contains provisions for consideration of small
businesses, including a requirement that the Secretary issue a “small entity compliance policy
guide” no later than 180 days after issuing regulations.
The Senate-passed bill (S.Amdt. 4715 to S. 510) also contained a provision that would clarify the
types of businesses that should be considered to be “retail food establishments” and therefore
generally not subject to the facility registration requirements. S. 510 specifies that roadside
stands, farmers’ markets, and foods sold through a community-supported agriculture (CSA)
program would also not be subject to the requirements.
70 It could be argued that this provision—and other provisions of S. 510 not readily applicable to farms—might
indirectly affect farms 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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Hazard Analysis and Risk-Based Preventive Controls
Section 103 of S. 510 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 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.”
As with other provisions, the Senate-passed bill contains language for consideration of small
businesses, including a requirement that the Secretary issue a “small entity compliance policy
guide” no later than 180 days after issuing regulations. It provides for extended implementation
deadlines for small and very small businesses: small businesses (as defined by the Secretary) are
to have two years after final regulation are promulgated, and very small businesses (as defined by
the Secretary) three years after final regulations. The bill also contains clarifying language
regarding the promulgation of FDA regulations, including consideration for various types of
businesses and activities (on-farm and at processing facilities).
The Senate-passed bill (S.Amdt. 4715 to S. 510) would further exempt certain food processing
operations from the proposed HACCP requirements under Section 103 if they are either a “very
small business” as defined by FDA in rulemaking, or if the facility’s “average annual monetary
value” of all food sold during the previous three-year period was less than $500,000, provided
that the food is sold directly to “qualified end users” such as consumers, restaurants, or retail food
establishments located in the same state where the facility sold the food or within 275 miles of the
facility. Such a facility would need to demonstrate that it either has “identified potential hazards
associated with the food being produced,” and is implementing and monitoring these preventive
controls, or that it is “in compliance with State, local, county, or other applicable non-Federal
food safety law.” Foods produced from such a facility would also need to provide the facility’s
name and address on a food packaging label or at the point of purchase. For more information see
discussion under “Senate Debate.”
Targeting of Inspection Resources for Domestic Facilities, Foreign Facilities, and
Ports of Entry; Annual Report
Section 201 of S. 510 specifically requires the HHS 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
S. 510 substantially modified the original version of Section 204 of S. 510. It requires the
Secretary, in consultation with USDA and state officials, to improve the capacity of FDA to
effectively and rapidly track and trace foods in the event of an outbreak. Within 270 days of
enactment, the Secretary is required to establish pilot projects in coordination with the food
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industry to explore and evaluate methods to rapidly and effectively identify recipients of food to
prevent or mitigate a foodborne illness outbreak and to address credible threats of serious adverse
health consequences or death to humans or animals as a result of such food being adulterated or
misbranded. Participants are to include one or more projects with the processed food sector and
one or more projects coordinating processors or distributors of fruits and vegetables that are “raw
agricultural commodities,” reflecting the diversity of the food supply. The projects must include
at least three different types of foods that have been the subject of significant outbreaks during the
five-year period preceding enactment, among other criteria for project selection intended to
inform future rule promulgation.
The Secretary shall publish a notice of proposed rulemaking to establish additional record-
keeping requirements for high-risk foods, subject to certain specified conditions, no later than two
years after enactment. The Secretary shall designate such high-risk foods within one year after
enactment based on criteria specified in the provision, and shall publish the list of the foods
designated as high-risk, which may be subject to updates and revision. The provision on record-
keeping addresses information protection; requirements for public input; and rules on retention of
records. It allows for the consideration of less restrictive requirements (as specified) for farm-to-
school or farm-to-institution programs of USDA and other related programs; food produced
through the use of a fishing vessel; producers of commingled raw agricultural commodities;
grocery stores; direct farm sales to consumers or grocery stores; and “identity-preserved labels”
on farm sales of food produced and packaged on a farm, among others. The Secretary may
modify requirements, or exempt a food or facility from them, if product tracing requirements are
not needed to protect public health. The provision also specifies the information the Secretary
may request from U.S. farms, subject to certain limitations, but specifies that the Secretary is not
authorized to impose any limitations on commingled foods. With the exception of farms, failure
to comply with record-keeping provisions under this section is prohibited.
As with other provisions in the bill, the Senate-passed bill contains provisions for consideration
of small businesses, including the requirement that the Secretary issue a ”small entity compliance
policy guide” and provide delayed implementation timelines for small and very small operations
to comply with the requirements. Small businesses (as defined by the Secretary) will have one
year after final regulations are promulgated, and very small businesses (as defined by the
Secretary) two years after final regulations to comply.
Concluding Observations on the Bills’ Provisions
The farm-related provisions of the original House- and Senate-passed bill 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 others. At issue is whether these changes will satisfy farm interests, what, if any
additional modifications might still be made, and their potential impact on food safety.
The House and Senate proposals 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. However, these
seemingly similar provisions appear to be somewhat more prescriptive under the House version
and could have a greater potential impact on producers, regardless of size, production, and/or
marketing practices. That may be one reason why the House-passed version of H.R. 2749 appears
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to contain more specific language than S. 510, in order to limit the applicability of the bill—or a
number of its specific provisions—to farms generally. The added provisions in the Senate-passed
bill, however, would arguably go further to mitigate the economic effects of the proposed
legislation for some small businesses that would otherwise be subject to the proposed facility and
produce standard requirements (in Sections 103 and 105) by specifically limiting the types of
food processing operations and farms that will be subject to these requirements.
Author Contact Information
Renée Johnson
Specialist in Agricultural Policy
rjohnson@crs.loc.gov, 7-9588
Acknowledgments
This report was originally written by Geoffrey S. Becker, Specialist in Agricultural Policy.
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