Order Code RL31853
CRS Report for Congress
Received through the CRS Web
Food Safety Issues in the 108th Congress
Updated August 16, 2004
Donna U. Vogt
Specialist in Social Legislation
Domestic Social Policy Division
Congressional Research Service ˜ The Library of Congress

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Food Safety Issues in the 108th Congress
Summary
Foodborne illness is a serious public health problem. The Centers for Disease
Control and Prevention (CDC) estimate that each year in the United States, 76
million people get sick, 325,000 are hospitalized, and 5,000 die from food-related
illnesses. There are many who think that these estimates understate the problem
because many people do not seek medical help for foodborne illness and so the
illness is not officially reported. Most consumers look to the government to regulate
and protect the food supply, and industry is interested in producing foods that are safe
at a reasonable price. Consequently, Congress is interested in oversight and
legislation in this area.
Several federal agencies, along with cooperating agencies in the states, are
responsible for assuring the safety, wholesomeness, and proper labeling of all foods.
The responsibilities under the current federal system are divided among two
departments and one independent agency. The U.S. Department of Agriculture
(USDA) regulates meat, poultry, and certain egg products while the Food and Drug
Administration (FDA), in the Department of Health and Human Services (DHHS),
sets and enforces standards for safety of all other domestic and imported foods. The
FDA is also responsible for ensuring that all animal drugs and feeds are safe, labeled
properly, and produce no human health hazard when used in food-producing animals.
The CDC, also part of DHHS, tracks foodborne illness outbreaks. The Environmental
Protection Agency (EPA) sets legal limits (tolerances) on the amounts of pesticide
residues allowed in or on food.
Production of food is often a multi-stage process involving many different
vendors and producers. Congress maintains close oversight over federal food safety
activities which consist of inspecting, testing, research, and monitoring the food
supply. In response to limited federal funding, FDA and USDA adopted an approach
to food safety known as the Hazard Analysis and Critical Control Point (HACCP)
system. It requires food companies to identify where hazards could enter food during
its preparation for market and to take steps to lower the risk of contamination.
Fears of terrorist attacks spawned legislation that has been assisting the federal
government in protecting the food supply. The Public Health Security and
Bioterrorism Preparedness and Response Act of 2002 (P.L. 107-188) requires FDA
to register food processors, inspect their records, and detain adulterated food. It also
requires that FDA issue regulations to ensure the safety of imported foods. In
addition, the act authorizes appropriations for USDA, to be used for enhanced border
inspection of food imports of plant and animal origin, lab biosecurity upgrades, and
increased research.
Bills have been introduced on food security issues, “mad cow” threats to the
food supply, new enforcement authorities for FDA and USDA, the safety of school
lunches and methylmercury in fish. Some Members of Congress continue to be
interested in the regulation of bioengineered foods, the growing public health
problem of antimicrobial resistance, the safety of fresh produce, and reorganizing the
federal food safety structure. This report will be updated regularly.

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Contents
Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
Problems in the Food Supply . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
Public Health Problems . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
Costs of Illness . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
Aftermath of the Terrorist Attacks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
Statutory Authority . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
FDA . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
USDA . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
EPA . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
Agency Framework for Food Safety . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
Federal Agencies’ Responsibilities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
Establishing Guidance and Regulatory Requirements . . . . . . . . . . . . . . 7
Enforcing Compliance with Inspections and Legal Requirements . . . . 8
Approving Food Additives and Labeling . . . . . . . . . . . . . . . . . . . . . . . . 9
Tracking Foodborne Illnesses . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
Role of State and Local Agencies in Food Safety . . . . . . . . . . . . . . . . . . . . 11
Congressional Oversight Structure for Food Safety . . . . . . . . . . . . . . . . . . . . . . 11
Funding . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
Recent Initiatives to Improve Food Safety and Security . . . . . . . . . . . . . . . . . . . 13
Registration of Food Processors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
Prior Notice of Imported Food Shipments . . . . . . . . . . . . . . . . . . . . . . 14
Establishment and Maintenance of Records . . . . . . . . . . . . . . . . . . . . 15
Administrative Detention . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
Other Food Safety and Security Provisions in P.L. 107-188 . . . . . . . . 16
Other Food Security Activities and Issues . . . . . . . . . . . . . . . . . . . . . . 16
Other Food Safety Issues . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
Mad Cow Disease Threat . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
Enforcement Authorities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
Reorganization of the Federal Food Safety Regulatory Structure . . . . 21
Regulation and Labeling of Genetically Engineered Foods . . . . . . . . . 23
Antimicrobial Resistance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
School Meal Food Safety . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27
Safety of Fresh Produce . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29
Methylmercury and Fish . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30
List of Tables
Table 1. Food Safety, Security, and Defense for FY2002, FY2003, FY2004,
the President’s Budget Request of FY2005, and the
House-passed Appropriation for FY2005 . . . . . . . . . . . . . . . . . . . . . . . . . . 12

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Food Safety Issues in the 108th Congress
Introduction
While most experts agree that the U.S. food supply is among the safest in the
world, every year foodborne pathogens in the food supply make many people ill
which causes some consumers to lose confidence in its safety. Concerns have been
raised about whether the federal regulatory system, as currently structured, adequately
deals with problems in the food supply. U.S. consumers worry that current safety
efforts may not be enough to provide the level of safety in the food supply that they
demand.
The nation’s food safety system consists of activities carried out by many
different federal, state, and local government agencies. Together they inspect, test,
research, and monitor the food supply. The type and amount of oversight depend on
the food product. For the most part, these agencies monitor whether the food
industry are adhering to their legal responsibility of ensuring the production of safe
food.
This report provides an overview of federal food safety activities and issues of
concern to Congress. The major areas of concern include illnesses caused by
foodborne pathogens, the cost of these illnesses, and the vulnerability of the food
supply to terrorist acts. It also describes activities of federal agencies charged with
ensuring that consumers can purchase “safe” food from appropriately regulated food
companies, and gives past and proposed appropriations for food safety. It describes
the new bioterrorism law which gives the Food and Drug Administration (FDA)
more direct authority over the food supply, particularly imports. Additionally, it
discusses a number of other issues including the debate in Congress over food
security issues, enforcement powers such as recalls, proposals to reorganize the food
safety regulatory structure, questions about regulating bioengineered food, the
growing problem of antibiotic resistance, and the safety of school lunches.
Problems in the Food Supply
The U.S. diet is composed of food produced all over the United States and the
world. For example, many U.S. consumers have become more weight conscious, and
are eating more lettuce as a lower calorie alternative food. Lettuce consumed
domestically may be grown domestically, or imported. Once lettuce is harvested, it
usually goes to a packing house where it is washed multiple times and packaged.
Increasingly, lettuce products are produced that contain pre-cut or mixed greens.
Then the product is transported throughout the country to food distribution
warehouses or facilities. At each stage in its journey, ownership of the lettuce may
change, and it may be handled by different people or machinery. Contamination or
adulteration, either intentional or inadvertent, can creep in at any point in this

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process. Accountability for food safety is often difficult because information about
product handling, processing and shipping may be limited and/or incomplete.
Public Health Problems. The Centers for Disease Control and Prevention
(CDC) estimate that foodborne diseases cause approximately 76 million illnesses,
325,000 hospitalizations, and 5,000 deaths each year in the United States.1 These
estimates are based on data from a variety of sources including surveillance systems,
death certificates, and academic studies. Often, victims of food poisoning do not
report their illness to a doctor or they mistake food poisoning for some other illness
such as influenza. CDC’s current estimates are higher than prior estimates due, in
part, to better surveillance data rather than changes in disease prevalence. Even so,
the most recent CDC preliminary surveillance data for 2003 indicate substantial
declines in the incidence of infections caused by Campylobacter, Cryptosporidium
parvum, Escherichia coli O157, Salmonella, and Yersinia enterocolitica when
compared with 1996-2002 data.2
While bacterial-based food illness shows a decline, bacteria can mutate. For
example, one strain of Escherichia coli (E. coli), a common bacteria found in
intestines of all birds and mammals, has mutated into a deadly form known as E. coli
O157:H7. It has been found in hamburger, and also in unpasteurized apple juice,
alfalfa sprouts, and packaged lettuce. A common but unusually virulent type of
Salmonella, called phage type 4, has been found in chickens and dairy cows. Both
pathogens have contributed to a number of foodborne illness outbreaks.3
In addition to bacteria, foodborne diseases and illnesses can be caused by
viruses, parasites, and fungi, directly, or by toxins produced by the pathogens.
Chemical or drug residues found in food can also have health effects.
Most cases of foodborne illnesses are classified as “acute.” These are usually
self-limiting and of short duration, although they can range from mild to severe.
Gastrointestinal problems and vomiting are common acute symptoms of many
foodborne illnesses. Deaths from acute foodborne illnesses are rare. However, FDA
estimates that 2 to 3% of all acute cases develop secondary long-term illnesses, called
“chronic sequellae.” Chronic sequellae of foodborne illness can occur in any part of
the body and subsequently can affect the joints, nervous system, kidneys, or heart.
These chronic illnesses may afflict the patients for the remainder of their lives or
1 U.S. Department of Health and Human Services, Centers for Disease Control and
Prevention, “Food Related Illness and Death in the United States,” Emerging Infectious
Diseases, vol. 5, no. 5, Sept.-Oct. 1999, at [http://www.cdc.gov/ncidod/eid/
vol5no5/mead.htm].
2 U.S. Department of Health and Human Services, Centers for Disease Control and
Prevention, “Preliminary FoodNet Data on the Incidence of Infection with Pathogens
Transmitted Commonly Through Food — Selected Sites, United States, 2003,” Morbidity
and Mortality Weekly Report, vol. 53, no. 16, Apr. 30, 2004, pp. 338-343.
3 U.S. Department of Health and Human Services, Centers for Disease Control and
Prevention, “Surveillance for Foodborne-Disease Outbreaks — United States, 1993-1997,”
Morbidity and Mortality Weekly Report, vol. 49, no. SS-1, Mar. 17, 2000, found at
[http://www.cdc.gov].

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result in premature death. For example, Campylobacter infections are estimated to
be responsible for 20 to 40% of Guillain-Barre syndrome cases (a major cause of
paralysis unrelated to trauma) in the United States.4 About 15% of E. coli O157:H7
disease patients develop hemolytic uremic syndrome (also known as HUS), which
involves red blood cell destruction, kidney failure, and neurological complications
such as seizures and strokes.5
Several factors contribute to public health officials’ increasing concern about
the risk of getting ill from food: (1) some sensitive population groups, such as the
elderly, the very young, pregnant women, and people with HIV/AIDS and cancer, are
particularly vulnerable to diseases caused by foodborne pathogens; (2) as people eat
out more frequently, and retail establishments process foods on-site, there is
increased opportunity for contaminated food to cause illness; (3) more cases of
illness from pathogenic organisms on fresh fruits and vegetables have been reported
and consumers are eating more produce for its nutritional benefits; and (4) the highly
mechanized, efficient production and long-distance distribution practices of the food
industry make it possible for a contaminated product to be quickly distributed
nationally or even internationally and give more opportunity for time and temperature
abuse, which can promote the growth of harmful organisms.
Costs of Illness. Foodborne illness imposes costs on the U.S. economy.
According to the U.S. Department of Agriculture (USDA), foodborne illness costs
are borne by the food industry, households whose members become ill, employers
and the public and private health sectors. USDA estimates costs associated with
medical expenses and losses in productivity from five major types of foodborne
illnesses at $6.9 billion annually (in August 2000 dollars).6 These costs include
medical costs, productivity losses from missed work, and an estimate of the value of
premature deaths, but exclude travel costs in obtaining medical care, and time lost
from work in caring for sick children. This methodology produces estimates that
vary based on the expected age distribution of those who become ill. For example,
the annual cost of foodborne illnesses caused by Salmonella decreases from $3.7
billion to $2.4 billion when adjusted for age of death because over two-thirds of the
deaths from salmonellosis occur in people over 65. Adjusting foodborne illness costs
by age of death raises cost estimates for E. coli O157:H7 because most deaths occur
in children under five. That estimate is $659.1 million. Estimates of E. coli and
4 Jeremy H. Rees, Sara E. Soudain, Norman A. Gregson, and Richard A.S. Hughes,
“Campylobacter jejuni Infection and Guillain-Barre Syndrome,” The New England Journal
of Medicine, vol. 333, no. 21, Nov. 23, 1995, pp. 1374-1379.
5 Craig S. Wong, Srdjan Jelacic, Rebecca L. Habeeb, Sandra L. Watkins, and Phillip I. Tarr,
“The Risk of the Hemolytic-Uremic Syndrome After Antibiotic Treatment of Escherichia
coli O157:H7 Infections,” The New England Journal of Medicine, vol. 342, no. 26, June 29,
2000, pp. 1930-1936.
6 Campylobacter, E. coli O157:H7, Shiga toxin-producing strains of E. coli, Listeria
monocytogenes, and Salmonella. See [http://www.ers.usda.gov/Emphases/SafeFood/].

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related pathogens costs are $329.7 million for a combined total of $988.8 million for
all E.coli-related illnesses and deaths in 2000.7
Aftermath of the Terrorist Attacks. The fall 2001 terrorist and anthrax
attacks have forced Congress, federal food safety policymakers, and food industry
officials to consider the nation’s readiness to protect against and respond to
intentional acts of food adulteration or the targeting of food production. There is
widespread concern that naturally occurring pathogens such as E. coli O157:H7,
Salmonella, Listeria, and botulinum toxin could be used as bioterrorist weapons and
could be spread through the multi-link food distribution chain. Such an attack would
be particularly lethal to children, the elderly, and the immune-compromised.
One likely goal of a terrorist action would be to cripple some part of the farm
to table continuum. Any link in the food production chain is potentially susceptible
to an attack. Such an attack could cause an erosion of public confidence in the food
supply and economic ruin for certain food producers.
Experts recognize weaknesses in the ability of most nations to prevent and
contain a biological attack on their food supply. Limited inspection capabilities, lack
of rapid diagnostic tools, inadequate coordination among inspection agencies, and
little biosafety training of the industry workforce are among the cited weaknesses.
Most nations have responded by instituting a variety of policies that help to prevent
or, if necessary, respond to an attack. U.S. activities are discussed below.
Statutory Authority
The federal government attempts to ensure that the food supply is safe from the
farm or port to the consumer’s table through statutory mandates and science-based
regulatory policies. Federal laws mandate how each federal agency approaches its
role in food safety, and these laws dictate very different approaches.
FDA. The Federal Food, Drug, and Cosmetic Act (FFDCA), which prohibits
the entry into interstate commerce of adulterated or misbranded foods, is
implemented by FDA. Section 402 of the FFDCA defines food as “adulterated” if
it “contains any poisonous or deleterious substance which may render it injurious to
health.” FDA has interpreted this authority broadly to include food that is defective,
contaminated, unsafe, etc. Under this authority, the agency has established guidance
and regulatory requirements for manufacturers to assure that food is safe and not
adulterated. To enforce the requirements, FDA monitors food manufacturers through
periodic inspections to judge whether they are producing foods appropriately. For
FY2004, FDA plans to use approximately 476 full-time equivalent (FTE) positions
in the inspection of domestic food manufacturers. This translates into about one
inspection every five years for most domestic food producing facilities.8 FDA also
monitors more than 5.4 million imported food entries annually at 90 ports of entry.
7 “Economics of Foodborne Disease: Feature,” found at [http://www.ers.usda.gov/briefing/
FoodborneDisease/features.htm].
8 U.S. Department of Health and Human Services, Public Health Service, Food and Drug
Administration, Statement of Lester M. Crawford, Deputy Commissioner, Food and Drug
Administration, before the Senate Committee on Governmental Affairs, Nov. 19, 2003.

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For this work, the agency has allocated 1,595 FTEs in FY2004.9 The agency has
more than doubled its import examinations from 34,447 in FY2002 to 78,569 in
FY2003, due in large part to increased surveillance of imported food during
Operation Liberty Shield (See below.)10
As part of its responsibility to prevent adulterated food from reaching
consumers, FDA has direct authority (Section 409 of the FFDCA) to approve of food
and color additives. The law defines a food additive to be any substance added
directly or indirectly to a food, including any substance used in “producing,
manufacturing, packing, processing, preparing, treating, packaging, transporting, or
holding food, and including any source of radiation intended for any such use.”11 An
industry or sponsor with a proposed food additive must file a petition for pre-market
approval with FDA that includes test data showing that the food additive meets the
FFDCA standard of “safe.” “Safe” means that there is a “reasonable certainty that
no harm would result from the substance under its intended conditions of use.”
USDA. Meat and poultry inspection requirements contrast sharply with FDA’s
mandate. The Federal Meat Inspection Act of 1906, as amended by the Wholesome
Meat Act of 1967, requires that USDA continuously inspect all cattle, sheep, swine,
goats, and horses brought into any plant to be slaughtered. It also requires that a
federal inspector be present for at least part of every shift while a firm is processing
meat products for human consumption. Congress instituted requirements for poultry
in the 1957 Poultry Products Inspection Act, amended by the 1968 Wholesome
Poultry Products Act. Under the meat and poultry acts, 7,680 Food Safety and
Inspection Service (FSIS) inspectors are responsible for inspecting meat, poultry,
and processed egg products for safety, wholesomeness, and proper labeling at 6,200
plants and import facilities. Such standards are similar to FDA’s mandate from the
FFDCA that calls for a prohibition of adulterated and misbranded food. USDA also
has established a mandatory program called Hazard Analysis and Critical Control
Point (HACCP) for meat and poultry plants. (See below.)
EPA. Under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA),
the Environmental Protection Agency (EPA) regulates the sale and use of pesticide
products. Under the authority of the “safety-only” clause, Section 408 of the
FFDCA, EPA sets limits (called tolerances) for pesticide residues in or on foods and
animal feed. Certain foods containing residues of pesticides are declared “unsafe”
if there is no tolerance established for the particular food/residue combination, or if
the residue level exceeds an established tolerance limit. Should this happen, the food
is considered “unsafe” or “adulterated” and cannot be sold in interstate commerce in
the United States. EPA has set over 9,000 pesticide residue tolerances. FDA and
9 Of the 1,595 FTEs, 970 FTEs will be used for import work such as inspections, computer
systems, and data examinations; 449 FTEs were allocated to enlarge FDA’s capacity for
laboratory analysis; and 176 FTEs will be used to inspect food plants in foreign countries.
Telephone conversation with FDA staff, Dec. 9, 2003.
10 U.S. Department of Health and Human Services, Public Health Service, Food and Drug
Administration, Statement of Lester M. Crawford, Deputy Commissioner, Food and Drug
Administration, before the Senate Committee on Governmental Affairs, Nov. 19, 2003.
11 21 U.S.C. 321 (s).

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USDA test and enforce those tolerances on their portions of the food supply. The
Food Quality Protection Act of 1996 changed the so-called “zero-risk” standard of
Section 409 of the FFDCA (the Delaney Clause) so that all food, both raw and
processed, has tolerances set under a standard that requires all residues to be “safe,”
and ensures that there is a “reasonable certainty of no harm” from the pesticide
residues.12
Agency Framework for Food Safety
The statutory structure governing food safety yields a regulatory system that
makes jurisdiction over food dependent on the type of food, the way the food is
processed, or the type of adulterant to be found in a particular food. Critics charge
that overlapping jurisdictions and duplication of effort waste taxpayers’ money and
result in a fragmented system that prevents an effective focus of resources on areas
where the risks of adulteration and contamination are greatest. Federal officials
argue that, by working cooperatively and through formal understandings among the
agencies, federal agencies now, for the most part, avoid duplicating efforts.
Federal Agencies’ Responsibilities
The diversity of federal agencies and departments with responsibilities for food
safety can be confusing. Specifically, within USDA, the Food Safety and Inspection
Service (FSIS) regulates meat, poultry, and processed egg products. Additional
agencies in USDA, the Cooperative State Research, Education and Extension Service
(CSREES), the Agricultural Research Service (ARS), and the Economic Research
Service (ERS), support intramural or extramural research on food safety and the
economics of foodborne illness. Other USDA agencies, the Food and Nutrition
Service (FNS) and the Agricultural Marketing Service (AMS), ensure the safety of
foods distributed through school nutrition programs. The FDA, CDC and NIH, all
housed within DHHS, play roles in food safety. Two centers in FDA — the Center
for Food Safety and Applied Nutrition (CFSAN) and the Center for Veterinary
Medicine (CVM) — ensure that all food produced domestically or imported (other
than meat, poultry, and processed eggs) is safe and that drugs given to animals raised
to be used for human food do not cause health problems for humans. The CDC
tracks foodborne illness incidents and outbreaks, and provides data and information
to the other food safety agencies. The NIH is responsible for research on the health
effects of foodborne illness and the effectiveness of possible treatments. The Office
of Pesticide Programs (OPP) of the EPA is responsible for setting tolerances: the
limit of the amount of residues from chemicals that can be found in or on food and
for promoting safer means of pest management. The National Marine Fisheries
12 21 U.S.C. §348(c)(3)(A) The Delaney Clause states “that no additive shall be deemed to
be safe if it is found to induce cancer when ingested by man or animal or if it is found, after
tests which are appropriate for the evaluation of the safety of food additives, to induce
cancer in man or animal ...” It means that no substance that induces cancer should be added
to the food supply, and implies that no substance that might cause cancer should even be in
the food supply whatever its source.

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Service (NMFS), in the Department of Commerce (DOC), provides fisheries
inspection services to assure the safety of commercial fisheries products.
In essence, the different agencies’ food safety responsibilities encompass four
basic functions that, when combined, have created a system that tries to assure the
safety of the food supply: (1) providing guidance to industry about what is expected,
and developing policies and regulations; (2) enforcing compliance by inspections and
programs; (3) giving pre-market approval to additives that will be added to food and
listed in the labeling; and (4) tracking and responding to foodborne illnesses in the
United States and overseas. Each federal entity may take a different approach when
implementing these functions.
Establishing Guidance and Regulatory Requirements. Federal
agencies develop regulations to minimize food hazards and guide the production of
safe food. These regulations, collectively called “good manufacturing practices
(GMPs),” are proposed after consultations with the industry, experts, the public, and
other interested parties and go through rigorous notice and comment periods. As
required by law, both FDA and USDA publish the GMP regulatory requirements in
the Federal Register. They then enforce these standards through inspections and
verification of documents. GMPs for food production represent generally recognized
practices for food processing and handling to avoid contamination with poisonous
or deleterious substances, filth, or potentially harmful microorganisms. GMPs also
address layout and maintenance of facilities, personnel qualifications, the cleaning
of equipment and utensils, and the processes and controls required to assure basic
sanitation and cleanliness. The major parties responsible for complying with the
GMPs, the manufacturers, producers, and distributors of food, must ensure that food,
when marketed in interstate commerce, is not adulterated and does not contain
unacceptable chemical residues.
In addition to publishing GMPs, FDA and USDA have adopted in the 1990s a
preventive approach to ensure safety of food. Called the “Hazard Analysis and
Critical Control Point” (HACCP) approach or system, it is a uniform science-based
approach to food safety. A HACCP program typically applies seven principles, based
on a technical analysis of the food production process, that is carried out by the food
plant itself. The seven principles are (1) analyze hazards; (2) identify critical control
points to control identified hazards;13 (3) establish the point at which a preventive
action must be taken; (4) establish procedures to monitor the control points; (5)
establish corrective actions to be taken when monitoring shows that a critical limit
has not been met; (6) establish procedures to verify that the system is working
consistently; and (7) establish effective record keeping to document the HACCP
system. The key to HACCP is the use of a microbiological approach to pathogen and
contamination control to prevent the contamination of food.
13 The most important and controversial step in HACCP is the choice of the critical control
points or CCPs. CCPs are where control must be exercised because loss of control of a CCP
is likely to result in contamination of a food. An example of a CCP would be a heat
treatment step (cooking) where a specific combination of time and temperature is maintained
to eliminate all pathogens. Under HACCP, food companies are responsible for identifying
and setting the limits of this critical step and putting in place control measures that are
activated when the limits are breached.

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The HACCP approach has been used by FDA in its low-acid canned foods
regulations for more than 30 years. The HACCP approach also gained industry
support when it called for giving more responsibility for assuring the safety of the
food supply to the food industry. Once the system is in place, FDA and FSIS review
industry records of monitoring at the critical control points to assure compliance and
evaluate the food products and facilities. In the mid to late 1990s, both agencies
mandated that certain food products (including seafood, fruit and vegetable juices,
and meat and poultry) have plans in place for a HACCP approach.
The federal government role is different under HACCP from its enforcement
role for GMPs because GMPs are very specific requirements that are published in the
Code of Federal Regulations and have statutory authority behind them. HACCP
plans, in contrast, are developed by the industry, and are tailored to the individual
facility or manufacturing line. When GMPs are not followed, official government
inspectors have the authority to determine that a food is adulterated and have the food
seized. Under HACCP the government role is to give guidance, oversee safety
programs, monitor records of the critical control points kept by the company, and
determine whether the company has corrected any problems that are discovered.
Some in industry argue that the HACCP rules are cumbersome, layered on top of
existing regulations, and are expensive to implement. Consumer groups argue that
HACCP plans need to be combined with GMP rules for HACCP plans alone may not
provide adequate regulatory oversight to assure food safety.
Enforcing Compliance with Inspections and Legal Requirements.
FDA has certain enforcement tools which it uses to assure that food is safe.
Enforcement generally begins with inspection. FDA officials, and some state
officials under contract with FDA, are authorized to enter and inspect, at reasonable
times, any factory, warehouse, establishment in which foods are manufactured,
processed, packed, or held prior to introduction into interstate commerce or in a
vehicle transporting food. Inspections of the 57,000 food establishments under
FDA’s jurisdiction occur on average once every five years. If violations are found,
FDA has had the authority since June 2002 to order the detention of a food during an
inspection. The detention is possible only if an FDA district director finds credible
evidence showing the food presents “a threat of serious adverse health consequences
or death to humans or animals.” In addition, FDA can request that the Justice
Department initiate an injunction, seizure, or prosecution. However, to bring the case
to the Justice Department, FDA officials must have substantial evidence that the food
is adulterated. Some critics of the current policy suggest that FDA needs further
enforcement powers such as mandatory recall authority to prevent contamination in
the food supply.
FDA uses a number of other administrative tools to enforce its safety
requirements. It sends warning letters and other regulatory correspondence, if
evidence has turned up from its inspections. The agency also creates import alert
lists which name importers who have previously tried to import a contaminated food.
It requests voluntary recalls, if a food has been tested and determined not to meet the
criteria under the law. However, it has no power to mandate recalls, nor can FDA
inspectors look at records kept by the plant to meet a state’s record-keeping
requirements unless the facility permits it.

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CRS-9
In contrast, USDA has more day-to-day involvement with the foods for which
it is responsible. Under the authority of the Federal Meat Inspection Act and the
Poultry Products Inspection Act (as mentioned above), FSIS inspectors (more than
7,680) must be continuously present at all the meat and poultry slaughter plants. For
other processing plants, inspectors make daily visits. This latter group has summary
powers to withdraw inspection services (which stops processing operations),
condemn foods, and obtain plant records.14 FSIS compliance staff investigate any
alleged violations of the meat and poultry inspection acts. FSIS can detain the
product in the plant or institute a seizure action requesting a federal district court to
direct a U.S. marshall to take custody of the product. Similar to FDA, FSIS does not
have mandatory recall authority.15
Approving Food Additives and Labeling. As mentioned above, FDA has
statutory authority to review food additive petitions. In its petition review process,
FDA determines within 90 days of submission (with a possible 90-day extension) the
types of food in which an additive can be used, the maximum quantity of the additive
that can be used, and the information that must appear on the label. During the
review, the agency assesses the risk associated with an additive. If the petition
establishes an adequate basis for finding that the use of a substance is safe, the
agency publishes in the Federal Register a regulation prescribing safe conditions for
use. In addition, the statute permits use, without prior agency approval, of a
substance with a long history of use, if it is considered “generally-recognized-as-safe”
(GRAS) such as salt, pepper, vinegar, and baking powder — substances found on a
list maintained by FDA.
When FDA concludes that a non-food substance used in the manufacturing,
packing, packaging, transporting, or holding of food might reasonably be expected
to migrate into the food even though its risk to human health is extremely small, the
agency regulates the substance as a “food contact substance.” At one time, these
substances were regulated as food additives, but, since 1997, the sponsor or
manufacturer only has to notify the agency of the substance’s identity, and its
intended use, and submit all necessary information to show that the substance is safe.
Unless FDA specifically objects, the manufacturer can begin using the food contact
substance immediately.
Genetically engineered (GE) food (foods made from seeds altered by
biotechnology or foods developed by other processes) may be reviewed by FDA for
safety. There is no mandatory review because the agency has ruled these foods as
14 In Dec. 2001, the U.S. Court of Appeals for the Fifth Circuit handed down a decision in
the Supreme Beef Processors Inc. vs. USDA case prohibiting USDA from suspending
inspections services based solely upon failure of the salmonella performance standard.
[Supreme Beef Processors, Inc. v. USDA, 275 F.3d432(2001)] Despite the ruling, USDA
has maintained the ability to initiate a withholding, suspensions, or withdrawal action based
on sanitation or hazard analysis and critical control points (HACCP) violations. Sarah
Muirhead, “USDA Sets New Procedures for Salmonella Testing,” Feedstuffs, vol. 74, no.
34, Aug. 19, 2002, p. 3.
15 For further information see CRS Issue Brief IB10082, Meat and Poultry Inspection Issues,
by Jean M. Rawson.

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CRS-10
equivalent to conventional foods. The agency concluded that GE food should be
treated similarly to “food contact substances.” In January 2001, FDA proposed a rule
that would require a food company to notify the agency 120 days prior to marketing
this food and, at the same time, supply the agency with test data showing its safety.16
The rule has not been finalized and several consumer groups, worried about safety,
have been urging Congress to require FDA to create a more formal safety system for
GE foods. One bill has been introduced into the 108th Congress which would require
FDA to set up a system requiring approval prior to the release of a GE food onto the
market. (See below for a further discussion.)
Tracking Foodborne Illnesses. As mentioned above, CDC has estimated
that each year large numbers of people get sick as a result of foodborne illnesses.
Such estimates spurred the Department of Health and Human Services (DHHS) to
enhance its tracking systems of these illnesses in order to recognize outbreaks more
quickly and begin steps to prevent their spread. In 1996, the FoodNet surveillance
system began collecting information about laboratory-diagnosed cases of foodborne
illnesses caused by nine pathogens, the major microbial pathogens found in the U.S.
food supply.17 FoodNet was created by CDC, FDA, and USDA because public health
officials, who rely on epidemiology to identify and track the source of outbreaks of
foodborne illness, did not have an accurate accounting of foodborne illnesses. Under
this system, doctors and laboratories report to local health departments when certain
pathogenic organisms are found in samples from ill patients. States then collect these
data and send reports to CDC where officials can then update the national
surveillance database and track foodborne illnesses. The most recent findings of the
FoodNet program, preliminary data from 2003, suggest an encouraging track record
in preventing foodborne illness compared to 1996 when tracking began, with
incidence of illness from some major pathogens having decreased, while the
incidence from others, relatively minor pathogens, remaining unchanged.18
If an outbreak is identified by CDC’s FoodNet’s active surveillance system,
strains of foodborne pathogens can be analyzed by CDC’s PulseNet, an networked
computer system linking public health laboratories in 50 states, as well as seven FDA
laboratories, and eight Canadian laboratories.19 This shared network system is used
by laboratories to rapidly identify strains by matching DNA “fingerprints” of
pathogens found both in food and in people stricken with foodborne illness, allowing
officials to detect outbreaks that cross state lines and to identify and remove
contaminated foods from commerce. With the help of this network, in May 2004,
16 Federal Register, vol. 66, no. 12, Jan. 18, 2001, pp. 4706-4738.
17 Campylobacter, Cryptosporidium, Cyclospora, E. coli O157:H7, Listeria, Salmonella,
Shigella, Yersinia, and Vibrio.
18 U.S. Department of Health and Human Services, Centers for Disease Control and
Prevention, “Preliminary FoodNet Data on the Incidence of Infection with Pathogens
Transmitted Commonly Through Food — Selected Sites, United States, 2003,” Morbidity
and Mortality Weekly Report, vol. 53, no. 16, Apr. 30, 2004, pp. 338-343.
19 See [http://www.cdc.gov/ncidod/eid/vol7no3/swaminathanG4.htm].

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CRS-11
Oregon State officials identified Salmonella Enteritidis in raw almonds as the cause
of illness in 29 people over 12 states and Canada.20
Role of State and Local Agencies in Food Safety
More than 85 state and 3,000 local regulatory agencies, including public health
and agriculture departments, license and inspect more than 1 million retail food
establishments (grocery stores, restaurants, nursing homes, etc.) under state laws and
regulations to ensure that consumers are protected from unsafe food. Often these
government officials use an FDA guidance manual called the Food Code, a hands-on
model of standards for state and local agency officials to follow when they carry out
inspections to prevent foodborne illnesses and to ensure that the food is not a vehicle
for communicable disease.21 The Food Code does not have the status of a regulation
for it has never been put through a notice-and-comment period for regulations. It is,
however, filled with advice and guidance based on the latest science and is updated
every two years. It contains, for example, suggested time and temperature controls
for cooking hamburgers, pork, and poultry and safe practices for handling food to
prevent cross-contamination. Of the 56 states and territories, 44 (79%) have adopted
state food safety codes patterned after some version of the FDA Food Code. Many
other states are conducting the rule-making process to adopt a more recent version
of the Food Code.
Congressional Oversight Structure for Food Safety
Several committees share congressional oversight for food safety. In the Senate,
food safety issues are considered by the Committees on Agriculture, Nutrition, and
Forestry; Government Affairs; and Health, Education, Labor and Pensions. In the
House, food safety is considered by the Committees on Agriculture; Energy and
Commerce; Government Reform and Oversight; and Science. The Appropriations
Subcommittee on Agriculture, Rural Development, Food and Drug Administration,
and Related Agencies also serves an oversight role in how the major agencies carry
out policies affecting food safety.
Funding
Table 1 provides the total appropriations for food safety activities of both FDA
and FSIS/USDA for FY2002, FY2003, and FY2004, the President’s request for
FY2005, and the House-passed appropriation for FY2005. Total funding for all
federal food safety activities increased 2.7% between FY2002 and FY2003, and 2%
from FY2003 to FY2004. The House has proposed a 7.2% increase for FY2005.
FSIS includes all its inspection activity costs in its food safety appropriation, while
20 CDC, Outbreak of Salmonella Serotype Enteritidis Infections Associated with Raw
Almonds — United States and Canada, 2004-2004,” MMWR, 53 (Dispatch) June 4, 2004,
pp.1-3. See [http://www.cdc.gov/mmwr/preview/mmwrhtml/mm53d604a1.htm].
21 For further information see [http://www.cfsan.fda.gov/~ear/fcadopt.html].

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CRS-12
only parts of FDA’s total inspections are budgeted for food safety because FDA
inspectors also check on the production and marketing of drugs, biologics, etc.
The House-passed FDA appropriation for FY2005 for food safety is $556.2
million, $48.1 million or a 9.5% increase in appropriations over FDA’s FY2004
appropriation of $508.1 million. This increase would far exceed the 1.7% increase
received in FY2003 and the .1% in FY2004. This total, however, is $21.7 million
(3.8%) less than the $577.9 million requested by the President. The agency plans to
use the large increase in funding for food defense activities, including increasing
testing capacity for the Food Emergency Response Network (FERN, see below),
research, domestic and import food-related inspections, Emergency Response and
Operations Network development, and coordination of food surveillance activities
within the biosurveillance initiative, a proposed surveillance program for early
detection of bioterrorism, which would include data on food testing.

Table 1. Food Safety, Security, and Defense for FY2002,
FY2003, FY2004, the President’s Budget Request of FY2005,
and the House-passed Appropriation for FY2005
(in millions)
FY2005
FY2005
House-
Agency
FY2002
FY2003
FY2004
Request
passed
Food and Drug
$499.0
$507.6
$508.1
$577.9
$556.2
Administration
Food Safety and
$730.1
$754.8
$779.9
$838.7a
$824.7
Inspection Service
Total
$1,229.1
$1,262.4
$1,288.0
$1,416.6
$1,380.9
a. About $124 million of this total would come from a proposed user fee for inspector overtime
hours.22
Sources: Food and Drug Administration, Office of Budget and Program Analysis, Budget
Formulation and Presentation Division. U.S. Department of Agriculture, Office of Budget and
Program Analysis, Budget Control and Analysis Division.
The House-passed FSIS appropriation for FY2005 for food safety is $824.7
million, $44.8 million or a 5.7% increase in funding over FDA’s FY2004
appropriation of $779.9 million. This increase would also exceed the 3.4% increase
received in FY2003 and the 3.3% in FY2004. This total, however, is $14 million
(1.7%) less than the $838.7 million requested by the President. Part of FSIS’s
increase will support USDA’s Office of Food Security and Emergency Preparedness
to coordinate the development of infrastructure to prevent, prepare for and respond
to an intentional attack on the U.S. food supply.23
22 See CRS Report IB10082, Meat and Poultry Issues, by Geoff Becker.
23 U.S. Department of Homeland Security, “Fact Sheet: Strengthening the Security of Our
Nation’s Food Supply,” July 6, 2004, [http://www.dhs.gov/dhspublic]

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Recent Initiatives to Improve
Food Safety and Security
Food security is defined broadly as protecting the food supply from deliberate
contamination and is therefore a subset of food safety with which it shares many
common activities. Since the terror attacks of 2001, a greater awareness of the
possibility of intentional tampering at any point in the food production, processing
and distribution chain has led to increased efforts to define and implement specific
preventive measures. One of the most significant actions in food safety and security
taken by the 107th Congress and the Bush Administration was enactment of the
Public Health Security and Bioterrorism Preparedness and Response Act (P.L. 107-
188) on June 12, 2002. The act responded to long-standing concerns about whether
FDA has sufficient authorities and resources to assure the safety of food. In the act,
Congress authorized extensions of FDA authority over food, particularly imports, to
better ensure the prevention and tracking of potential food adulteration, and to give
the agency more information about the food supply.24 Among other provisions, the
act required that FDA promulgate regulations by December 12, 2003 for the
registration of food processors; prior notification of proposed food imports; and the
establishment and maintenance of records. FDA published two interim final rules
on October 10, 2003, to help domestic and foreign food establishments minimize the
risk that food under their control could be subject to intentional contamination. The
rules were implemented on December 12, 2003, but FDA has asked its inspectors to
flexibly enforce them (FDA calls this their “transitional compliance policy”) while
establishments and traders become accustomed to the new rules.25 In addition, the
agency has launched an extended education program here and abroad to inform
participants along the farm to table continuum about the new requirements.
Registration of Food Processors. The act requires FDA to establish a
one-time registration system for any domestic or foreign facility that manufactures,
processes, packs, and handles food in or for the United States. On October 10, 2003,
FDA issued proposed rules to require that all domestic and foreign food facilities
register with the FDA by December 12, 2003, giving the agency information about
the identities (brand names) and the general food categories under which business is
conducted, and the addresses of all the companies’ facilities.26 As of June 24, 2004,
208,277 facilities had registered with FDA (98,896 domestic and 109,381 foreign).27
The agency is encouraging the information to be submitted electronically rather than
24 All four proposed rules exempt firms and products regulated exclusively by USDA.
25 Food and Drug Administration, “FDA and CBP Announce their Transitional Compliance
Policy on Food Imports Under the Bioterrorism Act,” FDA News, Dec. 11, 2003, p.103 at
[http://www.fda.gov/bbs/topics/NEWS/2003/NEW00995.html].
26 Food and Drug Administration, “Registration of Food Facilities Under the Public Health
Security and Bioterrorism Preparedness and Response Act of 2002,” 68 Federal Register
58894-58973, Oct. 10, 2003.
27 Testimony of Acting Commissioner of the Food and Drug Administration Lester M.
Crawford in U.S. Congress, House Committee on Energy and Commerce, Subcommittee on
Health, Implementation of the Food Security Provisions of the Public Health Security and
Bioterrorism Preparedness and Response Act, hearing, 108th Cong., 2nd sess., June 25, 2004.
(Hereafter cited as Testimony of Acting Commissioner Crawford, June 25, 2004.)

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CRS-14
by mail, although mail-in registrations will be accepted. Restaurants, certain retail
stores, non-profit feeding establishments, fishing vessels, trucks and other motor
carriers, and farms are exempt from these registration requirements. The act protects
registry data and any registration documents from public disclosure under Section
552 of Title V, U.S. Code (the Freedom of Information Act). In February 2004, FDA
issued its third guidance regarding registration of food facilities.28 It stressed that
firms must register even if a food firm does not know that its product will be used in
a food. Supporters believe the registration system will permit FDA to obtain an
accurate inventory of its regulatory purview and will enhance the agency’s capability
to trace intentionally and unintentionally contaminated food. Critics argue, however,
that this method of registration creates an enormous record keeping burden for FDA
without evidence that it would help facilities respond in an emergency.
Prior Notice of Imported Food Shipments. Also on October 10, 2003,
FDA published an interim final rule, effective December 12, 2003, requiring that
food importers give advance electronic notification prior to importation of food.29
The interim final rule states that the FDA must be notified and certify receipt within
no fewer than two hours of arrival of shipments by road, four hours by air or rail, and
eight hours by water. The shipment must have a U.S.-located agent accompany it.
If the agent accompanies the food into the country, the notification period will
depend on his/her mode of transportation. Such time frames must provide FDA with
sufficient time to review, evaluate and assess the information and determine whether
to inspect the imported food shipment. If notice is not given, the food will be refused
entry and be held at the port or in secure storage. The intent is that the notification
will protect U.S. consumers from unscrupulous importers and will help FDA ensure
that imports comply with U.S. regulations. A few critics are concerned that the
administrative cost of staff hours for complying with these new rules may raise the
price of food. However, with the phased in enforcement process, supporters argue
that the earlier anxiety has diminished as shipments have not been held up as
anticipated.
As part of the interim final rule, FDA and the Bureau of Customs and Border
Protection (CBP, part of the Department of Homeland Security) announced that they
have integrated their information systems so food importers, when filing prior notice
of imports, will be able to provide the required information using the CBP’s existing
Automated Commercial System. The prior notice for importers will allow FDA and
CBP to target import inspections more effectively, according to FDA. Critics claim
that the CBP system will be overloaded with the amount of information that will be
required.
At a June 25, 2004 hearing, FDA Acting Commissioner Lester Crawford stated
that on August 13, 2004, FDA will begin, with Customs, the “full enforcement” of
28 Food and Drug Administration, “Questions and Answers Regarding the Interim Final Rule
on Registration of Food Facilities (Edition 3),” at [http://www.fda.gov/oc/
bioterrorism/bioact.html].
29 Food and Drug Administration, “Prior Notice of Imported Foods Under the Public Health
Security and Bioterrorism Preparedness and Response Act of 2002,” 68 Federal Register,
58974-59073, Oct. 10, 2003.

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CRS-15
the registration and prior notice requirements.30 On that day, FDA will no longer
permit any imports without a complete prior notification. On those shipments
allowed entry, the agency will apply risk assessment findings to target its inspections
to those shipments deemed highest risk. FDA is expected to be able to inspect 2%
of all shipments in this way. Industry representatives complain that FDA should
exempt from the requirements food samples imported solely for research and
development use (such as a new cereal of a competitor) because the importer often
cannot secure needed registration numbers. On June 23, 2004, Representative
Conyers introduced H.R. 4665, the Importation of Safe Food Act of 2004, which
would prohibit the automatic rejection of food at U.S. borders solely on the basis of
an incomplete notice unless there is evidence of a threat to health.
Establishment and Maintenance of Records. The act also requires the
FDA to promulgate rules requiring food manufacturing establishments to keep two
years of production and distribution records. FDA published a proposed rule on May
9, 2003;31 it has not been finalized. Under this proposed rule, FDA inspectors would
have access to all processing, packing, transporting, receiving, holding, importing,
and distribution records in the event of a suspected food safety problem (including
terrorism-related contamination). The records must document the “immediate
previous source” of the food as it enters the facility and “immediate subsequent
distribution point” of the food as it leaves the facility. The proposal also would allow
companies to keep the required information in any form that they prefer and use
existing records to satisfy the requirements.
Access to these records is important because of the multi-staged nature of food
production, according to the agency. Such rules will allow the FDA to better track
and control a food product suspected of being used in a biological attack or in the
general context of protecting the public health. The act limits access to records that
may contain trade secrets or confidential information on recipes, and financial,
pricing, personnel, research, and sales data; it directs the Secretary to ensure that
there are effective procedures to prevent the unauthorized disclosure of any trade
secret or confidential information that is obtained during review of records. FDA, in
its proposed rule, reemphasizes in instructions to FDA personnel the importance of
current protections and legal requirements against the unauthorized disclosure of any
trade secret or confidential information. As with facility registration, access to
industry data is expected to make it easier for the agency to determine the cause and
scope of distribution of an adulterated or misbranded food and allow FDA to address
credible threats of serious adverse health consequences or death to humans or
animals. FDA also is allowed to reduce the record requirements for small businesses
and to exempt farms, restaurants, and fishing vessels not engaged in processing.32
30 Testimony of Acting Commissioner Crawford, June 25, 2004.
31 Food and Drug Administration, “Establishment and Maintenance of Records Under the
Public Health Security and Bioterrorism Preparedness and Response Act of 2002,” 68
Federal Register, 25188-25240, May 9, 2003.
32 21 USC §350c.

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CRS-16
Statutes governing meat and poultry inspection allow FSIS to inspect slaughter
and processing plant records, FDA has never before had the authority to either
require that food processors keep records or to inspect them. Opponents are
concerned that the proposed records inspection requirements could force a company
to retain lot numbers for each article it sends or receives, a costly activity because,
pallets often contain lots from multiple-sources so this would require breaking pallets
open to record lot numbers. They suggest instead that the agency require information,
within 24-hours after purchase, the sources and recipients of ingredients at the most
precise level possible.
Administrative Detention. The act gives FDA the authority to detain food
imports — hold them in place — under certain conditions. Although this authority
came into effect immediately upon the law’s signing, so far FDA has not used it. The
FDA finalized its related rule on June 4, 2004, in which it described the “credible
evidence” needed to prove that a food presents a threat of serious adverse health
consequences or death to humans or animals.33 An FDA district director or a more
senior official can now order the detention of a suspected food for up to 30 days, if
necessary. The owners must pay the expense of moving any detained food to secure
storage. Perishable foods (fruits, vegetables and seafood, for example) will be
subject to an expedited detention process with a fast appeals process.
Other Food Safety and Security Provisions in P.L. 107-188. The act
prohibits any importer who is a convicted felon for offenses related to the importation
of food, or has a pattern of importing adulterated food, from presenting any further
shipments for entry into the United States. It also authorizes the Secretary of HHS
to commission officials of other federal agencies to conduct examinations,
inspections, investigations, and related activities at facilities jointly regulated by HHS
and another agency. (FDA has already begun to do so with CBP officials.) The act
also authorizes appropriations to be used for additional food bioterrorism activities.
Proponents contend that this funding is needed because of the cost of preparing for
a bioterrorist attack. Critics of these provisions point out that FDA, together with the
food industry, has developed and promoted, since the 9/11 attack, the adoption of
“best practices” for the security of manufacturing facilities (see below). Some food
industry representatives claim that the industry needs no further funding, guidance,
or inspection to ensure facility safety.
Other Food Security Activities and Issues. On February 3, 2004, the
Department of Homeland Security made public “Homeland Security Presidential
Directive #9" (HSPD#9) requiring improved coordination by all the food safety
agencies to improve surveillance systems, and to complete vulnerability assessments
and plans for response and recovery in the event of a terrorist incident.34 The
agencies are also developing common screening and inspection procedures for
imported agriculture and food items. In a July 6, 2004 fact sheet from DHS, both
FDA and USDA announced that by working together many of their current food
33 Food and Drug Administration, “Administrative Detention of Food for Human or Animal
Consumption Under the Public Health Security and Bioterrorism Preparedness and
Response Act of 2002,” 69 Federal Register 31659, June 4, 2004.
34 See [http://www.dhs.gov/dhspublic/interapp/press_release/press_release_0453.xml].

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CRS-17
safety activities are being modified to comply with HSPD#9. For example, both
agencies have conducted vulnerability assessments to determine where intentional
contamination could cause illness or death, or simply disrupt the food supply to U.S.
consumers. These assessments have not been made public for security reasons. As
described above, the path that food travels is complex and food is often not carefully
watched or controlled. Both agencies have issued various guidelines on how the food
industry can prepare itself to identify and respond to bioterrorist threats. In March
2003, FDA finalized two guidance documents — for operators of domestic food
establishments and food importers — giving criteria on how they could lower the risk
of intentional contamination.35 The guidelines identify actions the food operators can
take to minimize the risk that the food they produce or manufacture could be
contaminated. For example, all the documents suggest that the food processing
plant’s management develop a recall strategy and plans to pre-screen staff before a
suspicious event and to investigate suspicious activity, to restrict access to certain
areas, inspect visitors and delivery personnel, and to secure the facility with fencing
or other appropriate barriers. On the same day, FDA released draft guidance for
retail food stores and food service establishments which gave similar suggestions.
On the other hand, on July 6, 2004, Secretaries Ridge and Veneman announced
awards to the University of Minnesota and Texas A&M University to become
“Centers of Excellence” on studying activities for food defense.
FDA and USDA/FSIS also have set up FERN, the Food Emergency Response
Network, to integrate 72 state and federal laboratories to analyze food samples
implicated in threats, terrorist events, or contamination. It links local, state, and
federal information to allow officials to prevent or respond to incidents of
contaminated food. A recent event showed that the agencies are combining resources
to ensure the safety of imported foods when intentional contamination is suspected.
On July 29, 2004, USDA received an anonymous email stating that a shipment of
lemons on an Argentine container ship had been contaminated with a bioterrorism
agent. Extensive testing revealed no problems, and the tip now appears to be a hoax.
News reports indicate involvement of the Coast Guard, FDA, USDA, and the state
of New Jersey in this incident.
While FDA established an Office of Crisis Management, USDA set up a special
Office for Food Security and Emergency Preparedness that will increase both
agencies’ surveillance and ability to test for pathogens related to bioterrorist threats.
Both have special homeland security teams trained to recognize threats to the food
system and others who coordinate agency activities with each other, the Department
of Homeland Security’s Customs and Border Protection, the Federal Bureau of
Investigation, and other agencies involved in food safety.36
35 These guidances are part of FDA’s support of Operation Liberty Shield, a comprehensive
national plan designed to increase the protections for U.S. citizens and infrastructure, while
maintaining the free flow of goods and people across U.S. borders. This multi-department,
multi-agency national effort is an attempt to minimize disruption of economic activity and
travel. FDA News, Mar. 19, 2003, pp. 3-18.
36 See CRS Electronic Briefing Book 73: Agroterrorism and Homeland Security, by Jim
Monke, Apr. 27, 2004.

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CRS-18
Even with these specific guidelines, neither FDA nor USDA has the authority
to impose security requirements on a food processing facility. A February 2003
GAO report defined these “outside” security activities as physical precautions:
perimeter fences, guards, alarms, outside lighting, background checks on employees,
and restricted access for movement within food facilities.37 GAO concluded that
neither agency could assess the industries’ efforts to prevent or reduce their
vulnerability to deliberate contamination because they could not require this baseline
data. The report also concluded that employees in food facilities had not been trained
to respond if there were a threat.38
Other Food Safety Issues
Although Congress has addressed certain food safety related issues in the
context of bioterrorism legislation, some observers argue that other and larger
reforms are necessary to improve the overall performance of the nation’s food safety
system.
Mad Cow Disease Threat. Since December 23, 2003, when a single U.S.
dairy cow was identified as having bovine spongiform encephalopathy (BSE), the
safety of the meat supply has been questioned. Although experts claim that the risk
to human health from consumption of meat from this BSE infected cow is minimal,
some have urged the Administration to carry out additional activities to safeguard the
food supply.39
BSE was first recognized in British cattle in 1986. Experts believe that feed,
made from rendered ruminant animal parts left after slaughter, was the source of
infection in cattle. To prevent an outbreak of BSE in the United States, FDA in 1997
instituted a ban on feeding certain rendered animal protein products to ruminants.
Since then FDA has made regular inspections of all renderers and feed mills and
37 U.S. General Accounting Office, Food-Processing Security: Voluntary Efforts Are Under
Way, but Federal Agencies Cannot Fully Assess Their Implementation, GAO-03-342, Feb.
2003.
38 Letter to Ann M. Veneman, Secretary, U.S. Department of Agriculture, and Tommy G.
Thompson, Secretary, U.S. Department of Health and Human Services, from Senator
Richard J. Durbin, Ranking Democratic Member, Subcommittee on Oversight of
Government Management, the Federal Workforce, and the District of Columbia, Senate
Committee on Governmental Affairs, and Senator Tom Harkin, Ranking Democratic
Member, Senate Committee on Agriculture, Nutrition, and Forestry, Mar. 13, 2003.
39 See CRS Issue Brief IB10127, Mad Cow Disease: Agriculture Issues for Congress, by
Geoffrey S. Becker; CRS Report RL32269, Transmissible Spongiform Encephalopathies
(TSEs), Including “Mad Cow Disease”: Public Health and Scientific Issues, by Sarah Lister
and Judy Johnson, and CRS Report RL32199, Bovine Spongiform Encephalopathy (BSE,
or ‘Mad Cow Disease’): Current and Proposed Safeguards, by Geoff Becker and Sarah
Lister.

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announced that 99% are complying with the 1997 ban.40 Additional safeguards have
been added through import restrictions and BSE surveillance.
When BSE was been found in the United States, on December 30, 2003,
Secretary of Agriculture Anne Veneman announced an immediate ban on the use of
any non-ambulatory or “downer” cattle in human food. On January 8, 2004, USDA
published final rules requiring that any animal tested for BSE could not be marked
“inspected and passed” until a negative test result were received; prohibiting use in
the food supply any skull, brain, or other neurological matter from cattle over 30
months of age; prohibiting the inclusion of any spinal cord tissue in advanced meat
recovery systems; and prohibiting the killing of cattle with air injection stunning to
ensure that portions of the brain are not dislodged into the tissues of the carcass.41
Supporters of these policies had wanted to see such department actions taken long
ago, but critics were concerned that removing downer cattle from the surveillance
systems at the slaughter houses may make it more difficult to detect cattle with BSE
if they are present in the population.
In February 2004, the USDA Secretary’s Advisory Committee on Foreign
Animal and Poultry Diseases recommended a one-year enhanced surveillance
program targeting cattle from the populations considered at highest risk for the
disease (cattle showing symptoms of central nervous system disease, non-ambulatory
cattle, and cattle that die on farms); and increasing the random sampling of
apparently normal, aged animals. The Committee also stated that a system should
be implemented to facilitate the collection of samples from dead and non-ambulatory
cattle, and federal funding assistance for their safe disposal. The Committee also
recommended the establishment of a verifiable national animal identification and
tracking system; federal support to approve additional regional laboratories to
conduct rapid screening tests for BSE; and the dissemination of accurate BSE
information to the media and members of the public.
On March 15, 2004, the Secretary of Agriculture, referring to the
recommendations of the Advisory Committee, announced details for an expanded
surveillance effort for BSE.42 The goal is to test as many cattle as possible in the
high-risk population, as well as a sample of older healthy animals (including some
that were born before the feed ban took effect), over a 12 to 18 month period. USDA
expects to test more than 200,000 animals, a ten-fold increase over prior annual
surveillance efforts. Approximately 36 million cattle are slaughtered annually in the
United States, though most are younger than the age (30 months) at which BSE is
thought to manifest.
40 Technical briefing and Webcast with U.S. government officials on BSE case. Comments
made by Dr. Lester Crawford, Deputy Commissioner of the Food and Drug Administration
Dec. 30, 2003 at [http://www.usda.gov/news/releases/2003/12/0451.htm].
41 USDA news release, USDA Issues New Regulations to Address BSE, found at
[http://www.fsis.usda.gov/oa/news/2004/bseregs.htm].
42 U.S. Department of Agriculture, “Veneman Announces Expanded BSE Surveillance
Program,” press release no. 0105.04, Mar. 15, 2004.

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To prevent the spread of prion infected materials, FDA published an interim
final rule on July 14, 2004, prohibiting specified risk material and other cattle
materials from being used in human food, dietary supplements, and cosmetics.43 It
also proposed a rule that would require manufacturers and processors of food and
cosmetics to keep records for two years showing that products do not contain the
prohibited cattle materials. On the same day, together with USDA, FDA published
an advance notice of proposed rulemaking (ANPR)44 that summarizes the Advisory
Committee’s February findings and solicits comments on its recommendations and
whether to prohibit specified risk material from all animal feed including pet food to
control the risk of cross-contamination; to prohibit the feeding of mammalian and
poultry products to other ruminants; to prohibit the use in animal feed of materials
from nonambulator disabled cattle and dead stock; and to further minimize the
possibility of cross-contamination of ruminant and non-ruminant animal feed by
requiring equipment, facilities or production lines to be dedicated to non-ruminant
animal feeds. Critics claim that some of these animal feed measures, now in the
ANPR, should have been finalized rather than published for comment for they would
significantly strengthen the multiple firewalls that protect U.S. consumers from BSE.
Critics also say that FDA has not delivered on its January 2004 promise when the
agency promised to prohibit blood and blood products, poultry litter,45 and restaurant
plate waste as feed ingredients for ruminants, and should have finalized these
measures.46
Enforcement Authorities. Recall authority and civil monetary penalties are
also receiving the attention of Congress and the Administration. Well-publicized
recalls of food products (including 27.4 million pounds of fresh and frozen poultry
luncheon meats considered at risk of containing Listeria monocytogenes; and green
onions (scallions) associated with hepatitis A outbreaks) have raised concerns over
whether the two major food safety agencies, the USDA and the FDA, have enough
authority to prevent contaminated food products from reaching consumers. Under
43 See 69 Federal Register 42256, July 14, 2004. Specified risk material is the brain, skull,
eyes, trigeminal ganglia, spinal cord, vertebral column and dorsal root ganglia of cattle 30
months and older and the tonsils and distal ileum of the small intestine of all cattle.
Prohibited cattle materials include small intestine of all cattle, material from nonambulatory
disabled cattle, cattle materials not inspected and passed for human consumption and
mechanically separated beef.
44 69 Federal Register 42288, July 14, 2004.
45 Poultry litter consists of bedding, spilled feed, feathers, and fecal matter that are collected
from living quarters where poultry is raised. This material is then used in cattle feed in
some areas of the country where cattle and large poultry raising operations are located near
each other. Poultry feed may legally contain protein that is prohibited in ruminant feed,
such as bovine meat and bone meal. The concern is that spillage of poultry feed in the
chicken house occurs and that poultry feed (which may contain protein prohibited in
ruminant feed) is then collected as part of the poultry litter and added to ruminant feed.
46 Plate waste consists of uneaten meat and other meat scraps that are currently collected
from some large restaurant operations and rendered into meat and bone meal for animal
feed. The use of plate waste confounds FDA’s ability to analyze ruminant feeds for the
presence of prohibited proteins, compromising the Agency’s ability to fully enforce the
animal feed rule.

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CRS-21
current statutes, both agencies must ask food firms to voluntarily recall any
hazardous product. Observers have charged that companies may be hesitant to issue
a recall in a timely manner, or may not recall as much product as food safety experts
suspect is contaminated. Some Members have suggested giving the regulatory
agencies mandatory recall authority in order to obtain a speedier response from the
food companies and to better protect consumers. An amendment to the House-
passed FY2005 agricultural appropriations bill (H.R. 4766) would require that FDA
and USDA jointly develop a website, to show pictures of the recalled product and the
email contact for the company that has announced the recall. Critics of mandatory
recall authority assert that such recalls would be costly to industry without necessarily
resulting in public health benefits. Critics also are concerned that the government
might take action before obtaining sufficient proof of adulteration, which could cause
economic harm to a company even if the recall subsequently turned out to be
unnecessary.
Several bills have been introduced to require mandatory notification when a
federally inspected establishment believes that its food product was adulterated or
misbranded, and issues a recall of the product. In addition, some bills would give
FDA and USDA the authority to suspend food processing by issuing a cease and
desist order, and impose civil penalties on plants that do not comply after they are
notified.47 The Meat and Poultry Inspection Accountability Act (H.R. 1003) would
authorize both FDA and USDA to assess up to $100,000 in civil monetary penalties
for a meat and poultry product if the manufacturer’s not complying with the agency
request to voluntarily recall unsafe food. Another bill, the Unsafe Meat and Poultry
Act (H.R. 2273) would amend the Federal Meat Inspection Act and the Poultry
Products Inspection Act to authorize the Secretary of Agriculture to order the recall
of meat and poultry that is adulterated, misbranded, or otherwise unsafe. A third bill,
the Safe and Fair Enforcement and Recall for Meat, Poultry, and Food Act (H.R.
3547, also called the SAFER Meat, Poultry, and Food Act) would not only extend
recall authority for meat and poultry, but would amend the FFDCA to also extend
recall authority over all food under the jurisdiction of FDA, and authorize a
maximum of $100,000 in civil monetary penalties. Consumer groups and food safety
advocacy groups have testified in favor of obtaining this new enforcement tool.
Interest in authorizing mandatory recall and penalties could increase with the
publicity surrounding the November 2003 outbreak of hepatitis A linked to green
onions imported from Mexico (see below).
Reorganization of the Federal Food Safety Regulatory Structure.
For many decades there has been a debate about the federal regulatory structure and
whether it should be changed. Some have proposed that the several different federal
agencies having responsibility for food safety be consolidated into a single entity.
Bills introduced into the 107th Congress would have placed USDA’s and FDA’s food
47 U. S. General Accounting Office, Food Safety — Actions Needed by USDA and FDA to
Ensure That Companies Promptly Carry Out Recalls, GAO 01-222, Aug. 2002. The report
criticized the agencies’ efforts in making sure that companies carry out recalls quickly and
efficiently, particularly of products that may carry severe risk of illness. GAO also stated
that neither FDA nor FSIS compiles sufficient information on companies’ recall schedules
or methods, and that determining the need for mandatory recall authority could not be done
until such data were available.

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CRS-22
regulatory agencies (FSIS, CFSAN, and CVM) and the Department of Commerce’s
National Marine Fisheries Service into a single independent food safety agency.
Proponents of the single agency concept charge that the current system is fragmented
and ill-equipped for meeting challenges from potential terrorist acts, as well as from
emerging pathogens, aging populations, and increasing levels of food imports.
Supporters say that a single agency would result in a more consistent and efficient
system for regulating food and that it would eliminate overlapping inspections of
foods such as cheese and meat pizza. Opponents maintain that a reshuffling of
bureaucracies would not necessarily provide safer food or the additional resources
needed for proper inspections. They also claim that food companies are producing
and distributing safe food and that the U.S. system is held up around the world as a
model for food safety.
At a March 30, 2004 hearing on food inspection, the General Accounting Office
(GAO) restated its long-standing criticism of the current food inspection system48 and
reemphasized the National Academy of Sciences’s (NAS’s) 1998 report calling for
greater coordination and statutory reform.49 At the same hearing in testimony given
by FDA’s food center director, Robert Brackett asserted that FDA and other food
safety agencies are effectively working together sharing information, scoping out
food safety research needs, and coordinating with many of the public health
initiatives of the Bush Administration.50 The Farm Security and Rural Investment
Act of 2002 (the 2002 farm bill), which the President signed into law on May 13,
2002, (P.L. 107-171), contains a provision creating a 15-member Food Safety
Commission that would review all the existing recommendations to improve food
safety and within one year, deliver a report to the President and Congress making
comprehensive recommendations for enhancing the U.S. food safety system. Neither
the FY2003, or the FY2004 appropriations bills nor the President’s request for a
FY2005 appropriation contain funding for the commission. There were no proposals
to reorganize the federal food safety agencies under the new Department of
Homeland Security. However, the HSPD #9 (mentioned above) would have FDA
and USDA coordinate plans and activities related to potential bioterrorist attacks.
The Directive appears to be the latest method of requiring the food safety agencies
to work together.
48 Testimony of Lawrence J.Dyckman, Director, Natural Resources and Environment, U.S.
General Accounting Office, Federal Food Safety and Security System: Fundamental
Restructuring is Needed to Address Fragmentation and Overlap, GAO-04-588T, in U.S.
Congress, House Committee on Government Reform, Subcommittee on Civil Service and
Agency Organization, hearings, 108th Cong., 2nd sess., Mar. 30, 2004.
49 See Ensuring Safe Food from Production to Consumption, available on the National
Academy website at [http://books.nap.edu/catalog/6163.html].
50 Statement of Robert E. Brackett, Director, Center for Food Safety and Applied Nutrition,
Food and Drug Administration, before the House Committee on Government Reform,
Subcommittee on Civil Service and Agency Organization, hearings, 108th Cong., 2nd sess.,
Mar. 30, 2004.

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CRS-23
Regulation and Labeling of Genetically Engineered Foods. Questions
have been raised in various Congresses as to whether genetically modified or
bioengineered foods are safe, and whether they should be labeled. Bioengineered
foods, or genetically engineered foods (GE foods), refer to the use of recombinant
DNA and related techniques to alter the genetic makeup in plants or living
organisms. These techniques allow scientists to identify and isolate genes of interest
from any organism and put them into other organisms. Scientists have developed
several types of engineered crops that contain traits making them either herbicide
tolerant (HT) or insect resistant because they contained the gene for the pesticide
produced by Bacillus thuringiensis (Bt), a natural pesticide. U.S. farmers have
rapidly adopted varieties of these crops. In 2003, 81% of the total soybean acreage
was planted with HT soybeans; 73% of the cotton acreage was planted with HT
cotton; and 40% was planted with HT corn.51 Other GE food crops planted and
marketed by U.S. farmers include canola, tomatoes, potatoes, papaya, squash, and
sunflowers.52
On January 18, 2001, FDA published a proposed rule,53 supported by the
industry, that would require that a food company notify the agency 120 days prior to
marketing a bioengineered food and, at that time, supply the agency with safety test
data. The proposed rule also strongly urged companies to consult the agency prior
to the mandated notification deadline in order to ensure agreement on the types of
safety testing that would be needed. After reviewing the submitted data, FDA would
either issue a letter to the company saying it has no safety concerns or expressing why
the product should not be marketed. FDA has not finalized this rule.
To encourage that some action would be taken, on June 17, 2004, Senator
Richard Durbin introduced the Genetically Engineered Foods Act (S. 2546) to require
premarket consultation and approval with respect to genetically engineered foods.
The producer must submit information that would allow the Secretary to detect the
modified gene and is adequate to enable the Secretary to assess the food’s safety.
The determination must be made publicly available and the agency must make the
notice, application, summaries submitted by the producer, and research, test results,
and other information referenced by the producer publicly available.
Currently, FDA does not require labeling of GE foods. In the same January
2001 Federal Register, FDA published a draft guidance for industry on voluntary
labeling of foods developed using bioengineering. In this document, FDA reaffirmed
that it believes, as it did in its 1992 regulatory guidance, that most genetically
engineered foods are substantially equivalent to their conventional counterparts. The
agency decided it would not require special labeling of all bioengineered foods
because it believes that the use of bioengineering, or its absence, does not itself cause
a material difference in the food. However, the agency did suggest that because of
51 See CRS Report RS21381, Adoption of Genetically Modified Agricultural Products, by
Geoffrey S. Becker.
52 For more information, see CRS Report RL30198, Food Biotechnology in the United
States: Science, Regulation, and Issues, by Donna U. Vogt and Mickey Parrish.
53 66 Federal Register 4706, Jan. 18, 2001.

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CRS-24
the strongly divergent views on labeling, manufacturers may consider providing more
information on the label about bioengineered food. The information given, however,
must be truthful and not misleading. To avoid false or misleading statements about
the absence of bioengineered ingredients (because there are no established threshold
levels of bioengineered constituents or ingredients in foods), or to avoid implying
that one food is superior to others, FDA suggests not using statements such as
“genetically modified (GM) free” or “biotech free.” The agency does suggest the
word “biotechnology” is preferred by some consumers over “genetic engineering” or
“genetic modification.” It also claims that if validated testing is available, it can be
used to verify whether the label is truthful. Or manufacturers could keep records to
document the reasons why a food’s label is truthful.54
Supporters of labeling have used the StarLink episode as being illustrative of the
need for truthful labeling. In 1998, EPA approved a gene-altered variety of yellow
corn called StarLink for use only as animal feed and set a zero-tolerance level for its
use in human food. The corn contains a naturally occurring bacterium (Bacillus
thuringiensis, or Bt.). Bt does not break down easily in the human digestive system,
is heat resistant, and could prove allergenic. A group supporting the labeling of GE
foods detected StarLink corn in taco shells in September 2000. The agencies took
quick action and millions of pounds of corn suspected of contamination were
destroyed. No illnesses nor allergic reactions from eating the food made with
Starlink corn were confirmed.
Since then, USDA has strengthened field-testing requirements for permits on
genetically engineered traits in plants that are not intended for food production, such
as pharmaceuticals and veterinary biologics. The agency added new safeguards as
a condition for all permits allowing the confined release of such products into the
environment.55 These specific safeguards include confinement procedures,
performance standards, and required monitoring/auditing practices for ensuring that
out-crossing or commingling with other seeds and commodities are prevented. The
new requirements are intended to prevent any pollen drift that could bring with it
intermittent low levels of genetically engineered-genes in food and feed crops under
development until all appropriate safety standards are met. These new requirements
took on a new urgency when one firm, ProdiGene, failed to manage former test sites
in Iowa and Nebraska. Corn containing an enzyme that was used to make a
pharmaceutical was mixed with soybeans and led to the destruction of 500,000
bushels of soybeans thought to be contaminated with the plant-based pharmaceutical.
The company has been fined $250,000 and is required to pay for the cost of
destroying the soybeans. The incident has caused the food industry to call for a
complete separation of plant-based pharmaceutical production from the food
supply.56
54 See CRS Report RS20507, Labeling of Genetically Modified Foods, by Donna U. Vogt.
55 68 Federal Register 11337, Mar. 10, 2003.
56 See CRS Report RS21418, Regulation of Plant-based Pharmaceuticals, by Geoffrey S.
Becker and Donna Vogt.

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CRS-25
On July 28, 2004, the National Academies released another report concluding
that federal agencies should continue to assess the safety of foods, whether produced
by genetic engineering or by other genetic modification techniques, such as
conventional breeding for desirable traits, on a case-by-case basis to determine
whether unintended changes in their composition could adversely affect human
health.57 The report said that the risks from GE foods are not unique, information on
the composition of GE foods should be made public, and more post-market
surveillance of these foods could create a data base of health effects on humans.
Supporters claim that GE foods have been carefully tested by industry, and that,
in fact, genetic engineering is more precise than traditional cross-breeding, a
technique that often transfers unwanted genes to the food plant. However, critics
question whether the agencies have scrutinized properly the long-term effects of
these products on human and environmental health, including any potential for an
unlabeled allergen to become part of the product. These critics want mandatory
labeling and consultation with the agency prior to marketing.
Antimicrobial Resistance. Public health experts are concerned about the
increasing numbers of people who do not respond to standard medical treatment
because the microorganisms causing their illness are resistant to the antibiotics
normally used to treat the illness or disease. Antimicrobial resistance in bacteria
occurs when genetic changes of a microorganism makes it resistant to antibiotics.
Incidences are increasing; in December 2003, 112 people in 21 hospitals in France
are reported infected with a bacteria resistant to many antibiotics.58
Although antimicrobial agents are used to treat illnesses both in humans and
animals, these agents are also used in food animals for nontherapeutic purposes.
Nontherapeutic use is when producers of food animals put small amounts of
antibiotics in animal feed so their chickens, cattle, and pigs grow faster, use less feed,
and don’t get sick as often. These nontherapeutic uses were formally defined in
legislation proposed in the 107th Congress as growth promotion,/ feed efficiency and,
sometimes, disease prevention. Nontherapeutic uses are being questioned because
the drugs, when used in food animals, can also promote genetic changes that make
microorganisms resistant to antibiotics used to treat human illnesses. For some large
scale animal producers, a farm might not be commercially viable without the routine
use of these drugs in feed. Some think use of antimicrobials should be severely
constrained to limit antimicrobial resistance. Others think the link between
widespread use in animal feed and increased antimicrobial resistance in humans is
not strong enough to warrant the added costs to food production.
The FDA states that due to the diffuse use of antimicrobials, it is difficult to
assess precisely whether the growing resistance in foodborne pathogens is
attributable to the use of antimicrobial drugs in food producing animals or some other
57 National Academy of Sciences, National Research Council, Safety of Genetically
Engineered Foods: Approaches to Assessing Unintended Health Effects, July 28, 2004,
National Academy Press, Washington, D.C.
58 The Associated Press, “Drug-Resistant Bacteria Spread in France,” New York Times, Dec.
11, 2003.

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use. On October 23, 2003, FDA released a new guidance document outlining an
evidence-based approach to preventing antimicrobial resistance that may result from
the use of antimicrobial drugs in animals. The document, Guidance for Industry
(GFI) #152 (Evaluating the Safety of Antimicrobial New Animal Drugs with Regard
to their Microbiological Effects on Bacteria of Human Health Concern), is not a
regulation. Instead it explains a science-based process that drug sponsors may use
when they seek approval of an antimicrobial for use in food-producing animals. The
new guidance encourages drug sponsors to use a risk assessment process to
demonstrate that an antimicrobial drug used to treat food-producing animals will not
create a risk of antimicrobial resistant bacteria likely to lead to human health
problems. FDA states that this process can help prevent antimicrobial drugs with a
high risk of causing such problems from being improperly used in food producing
animals, and thereby potentially leading to antimicrobial resistance in humans.
Even given this guidance, GAO claimed in an April 2004 report that FDA and
other federal agencies lack data on antibiotic use in animals used for food to support
research in human health risks.59 In comments on the report, HHS suggested it needs
new rulemaking to get data from drug manufacturers that would actually show which
antibiotics are used in food animals. From this data, the agency could monitor
antimicrobial resistance to develop national policies.
Meanwhile, the animal drug industry has championed a study published in
December 2003 by human and veterinary medical experts who found little evidence
that antibiotic use in animals poses a significant risk to human health, and that their
use keeps animals healthy. The experts examined data from Europe’s experience
with banning the use of antibiotics for performance enhancement. Europe’s
experience shows the ban increased animal suffering and disease without decreasing
rates of antibiotic resistance in humans.
According to a July 21, 2004 report by the Infectious Disease Society of
America, the number of drug-resistant infections including foodborne infections
caused by Salmonella continues to rise, while the number of new antibiotics in the
pipeline to combat the infections is declining drastically.60 The report contains a
table showing that since 1998, only 2 novel antibiotics (linezolid and daptomycin)
have been approved by FDA, and only 5 new antibiotics are in the drug pipeline out
of more than 506 drugs in development. It called upon Congress to increase funding
to several federal agencies to increase the number and size of research grants; reduce
the cost of clinical trials by providing tax incentives; and establish liability
protections to reduce companies’ risks. In addition, according to the report, FDA
should develop a “wildcard patent extension” in which a company that creates a
priority antibiotic could extend the marketing exclusivity period of another
FDA-approved drug as long as the company commits to investing a portion of the
profits derived during the extension to antibiotic research and development.
59 U.S. General Accounting Office, “Antibiotic Resistance: Federal Agencies Need to Better
Focus Efforts to Address Risk to Humans from Antibiotic Use in Animals,” GAO-04-490,
Apr. 2004.
60 Infectious Diseases Society of America, Bad Bugs, No Drugs: Antibiotic Discovery
Stagnates ... A Public Health Crisis Brews, July 2004. See [http://www.idsociety.org].

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CRS-27
A year ago, on July 25, 2003, Representative S. Brown and Senator Kennedy
introduced the Preservation of Antibiotics for Medical Treatment Act of 2003 (H.R.
2932/S. 1460), which would provide for a phased elimination of the routine feeding
to food-producing animals the same antimicrobial drugs also used in humans. The
bills would require that manufacturers show that their nontherapeutic use in food
animals does not pose a threat to public health. The bills would allow therapeutic use
of the drugs to treat sick animals and pets. In addition, the bills would require
manufacturers of antimicrobial drugs used routinely in animal feed to report annual
sales information. S. 1460 also includes payments to livestock or poultry producers
to defray the costs of reducing such drugs’ use, with priority given to family-owned
or small farms and ranches, and authorizes grants for university research and
demonstration programs to phase out the nontherapeutic use of critical antimicrobial
animal drugs in livestock or poultry. Supporters claim that scientific experts have
shown that the overuse of antibiotics in medicine and livestock are the two chief
contributors to the growth in antibiotic resistance in this country. Critics claim that
other uses of antimicrobials are the major cause of resistance in humans.
In 2000, FDA decided to withdraw the approval of the use of a type of the
fluoroquinolone antibiotic called enrofloxacin (Baytril) in poultry.61 FDA determined
that this drug’s use (and sarafloxacin hydrochloride which was withdrawn
voluntarily) in poultry causes the development of fluoroquinolone-resistant
Campylobacter. FDA claimed that the resistant Campylorbacter is transferred to
humans in the food and had become a hazard to human health. The manufacturer of
Baytril, Bayer Corporation, argued before an administrative judge in 2003 that FDA
had not presented evidence showing Baytril was unsafe and that withdrawing the
drug would result in higher pathogen loads on poultry carcasses. The judge on
March 16, 2004, decided in favor of FDA and backed the agency’s plan to take
Baytril off the market. The Bayer Corporation appealed this decision, and after
several legal actions, the decision regarding withdrawal rests with the acting FDA
Commissioner.
The conferees on the FY2004 appropriations put in language similar to that
found in H.R. 3022 that strongly encourages the Secretary of Agriculture to ensure
that the school lunch programs do not purchase poultry that has been treated with
fluoroquinolones.62
School Meal Food Safety. The federal government supports
school-sponsored meal programs for children (e.g., the School Lunch and Breakfast
programs) with per-meal cash subsidies and federally donated food commodities.
More than 35 million meals a day are served through these programs. The
overwhelming majority of food items procured for these meals are purchased by
school food authorities; but 10%-20% is purchased and donated to schools by USDA.
All federally donated foods must meet federal procurement standards, and the
standards for food safety include mandatory recall requirements where there are
known health hazards. For foods purchased by schools themselves, local schools
establish their own procurement rules and are notified when USDA and FDA are
61 65 Federal Register 64954, Oct. 31, 2000.
62 Congressional Record, vol. 149, no. 174, (Nov. 25, 2003), p. H12446.

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CRS-28
monitoring voluntary recalls. While USDA requires a minimal number of food
safety inspections, and gives technical assistance to schools to help ensure that their
procurement and food preparation practices are safe, there is no comprehensive set
of federal school food safety requirements or standards.
At times, food served in school-sponsored meal programs has made children ill,
or resulted in death. In the 108th Congress, two identical bills, the Safe School Food
Act of 2003 (S. 506 and H.R. 1551), which amend the Richard B. Russell National
School Lunch Act, proposed to increase the number of school food safety
inspections. These bills also required that school food procurement policies
incorporate federal procurement practices and mandate pathogen testing; required
that schools develop food safety hazard management plans; authorized USDA to
promote voluntary recalls of unsafe food products distributed to schools and order
mandatory recalls; required that states designate school food safety coordinators; and
established an advisory committee to aid in setting up a food safety
information-sharing database to improve the purchase and inspection of food for
schools. Proponents have contended that public confidence in the safety of the U.S.
food supply and the safety of school meals would be bolstered by federal school food
safety requirements/standards and by providing more extensive information to
schools on the food safety history of entities providing the foods they buy. On the
other hand, there was concern that this initiative was too sweeping (e.g., giving
authority for mandatory recalls to USDA) and might prove to be very difficult to
carry out at the local level.
Another approach to ensuring the safety of school meals that has been discussed
would deal with the issue by focusing on the preparation of meals and the handling
of food in schools. On April 3, 2003, in testimony before the Senate Committee on
Agriculture, Nutrition and Forestry, Eric M. Bost, USDA’s Undersecretary for Food,
Nutrition and Consumer Services, stated that the Administration supports a healthy
school environment and recommends changes to the law regarding child nutrition
programs. Food safety is part of this environment. Consequently, he stated that, to
ensure the delivery of safe and nutritious food, the Administration recommended
requiring that school food authorities employ HACCP procedures in the preparation
and service of school meals. In May 2003, GAO published a report on school meal
programs, which stated that between 1990 and 1999, about 3% of a total of 7,390
U.S. reported foodborne outbreaks occurred in schools. To lower this percentage
further, the report recommended that (1) CDC modify its foodborne outbreak
reporting mechanism to allow states to report whether the outbreak involved foods
served in federal school meal programs; (2) USDA make its stringent purchasing
specifications more readily accessible; (3) USDA encourage training and certification
of school food service personnel; and (4) USDA consider donating only precooked
or irradiated meat and poultry to the school lunch program, although this latter
recommendation could increase the cost of these foods, according to critics. Critics
also are concerned that the recommendation to add questions about the location and
type of commodity of the outbreak to the reporting function by local health officials
may be onerous.

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CRS-29
Another, broader approach toward safe food was suggested with the introduction
of the National Food Safety Database Act of 2003 (H.R. 3628) on November 21,
2003 by Representative Schakowsky. This legislation proposes to set up an
electronic database containing information on adulterated and/or misbranded foods.
It would include agencies’ enforcement and recall actions, outbreaks of foodborne
illnesses, and reported food inspection problems. Designated state officials would
have access to this information to help the procurers of food for schools, hospitals,
nursing homes, and child care facilities.
The 108th Congress decided on the following approach to legislating in the area
of school food safety. Section 111 of the Child Nutrition and WIC Reauthorization
Act of 2004 (P.L. 108-265) increases the number of required food safety inspections
(from a minimum of once-a-year to twice-a year), requires that reports on recent
inspections be publicly available, mandates that states and the USDA “audit” the
inspection reports, and adds a requirement (as requested by the Administration) that
schools implement HACCP systems (designed by the Secretary of USDA).
A related issue is the irradiation of foods used in school meals. Food irradiation
is a process in which food products are exposed to radiant energy such as gamma
rays, electron beams, or x-rays in amounts that destroy foodborne disease-causing
bacteria. On December 2, 1997, FDA approved the use of irradiation of red meats.
Approval came after FDA examined the impact on the nutrient content of irradiated
products, potential toxicity concerns, and the death of microorganisms in or on
irradiated products By 2001, USDA had approved its use in raw meats, meat
by-products, poultry, and eggs in shells. Under the terms of the 2002 Farm Bill (P.L.
107-171), USDA announced it will offer on a voluntary basis irradiated ground beef
to schools in the near future. The majority of ground beef used in these feeding
programs is provided by USDA. In response to this provision, bills were introduced
(H.R. 3120 and H.R. 3416) to ensure that information about irradiated foods would
be provided to the school staff, parents, and students, and that all irradiated food
products would be distributed with a label saying it had been irradiated, and students
would always have the option of a meal choice of non-irradiated foods. Provisions
effectively incorporating these proposals and the existing rule for a voluntary offering
of irradiated foods were incorporated into the Child Nutrition and WIC
Reauthorization Act of 2004 (Section 118).
Safety of Fresh Produce. In November 2003, CDC reported a multi-state
outbreak of hepatitis A, a viral infection that caused hundreds of illnesses and three
deaths, and was linked to green onions imported from Mexico.63 The produce
industry is currently coping with hundreds of cases of illnesses caused by Salmonella
javiana found in Roma tomatoes in Pennsylvania, Ohio, West Virginia, and
Maryland as of July 22, 2004. These are only two examples of recent outbreaks
linked to fresh produce. Contaminated fresh produce may pose a risk of microbial
illness because it is often intended to be eaten raw. Also, both consumption and
importation of produce are on the rise.
63 CDC, “Hepatitis: A Outbreak Associated with Green Onions at a Restaurant — Monaca,
Pennsylvania, 2003,” MMWR 52(47); Nov. 28, 2003, pp. 1155-1157.

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In late June 2004, FDA shared with industry representatives a new draft
framework for produce safety which covers practices in the entire supply chain from
farm to table. The plan covers both domestic and imported fruits and vegetables.
Methylmercury and Fish. Concerns about exposure to methylmercury
(MeHg) from consumption of certain fish continue to prompt government action. FDA
is responsible for the safety of commercial fish, while EPA is responsible for the
safety of recreationally-caught fish. Many states also monitor the safety of fish within
their borders and issue consumption advisories for recreationally-caught fish. Mercury
occurs naturally in the environment and is released into the air through industrial
pollution. Mercury then falls from the air and accumulates in streams and oceans.
Bacteria in the water cause chemical changes that transform mercury into MeHg. Fish
absorb the MeHg as they feed in these waters. MeHG builds up more in some fish
than others depending on what they eat, how long they live, and how high up the food
chain they are.
Exposure in young children and fetuses to MeHg has been linked to
neurodevelopmental injury, mental retardation, and other effects. A controversial
study by the National Academy of Science in 2000 estimated that “each year about
60,000 children may be born in the United States with neurological problems that
could lead to poor school performance because of exposure to methylmercury in
utero.”64 Some were critical of numerous assumptions leading to that conclusion,
while others have argued that the health benefits of fish were ignored and that
consumers would avoid fish altogether.
Although each agency had previously issued separate statements on this food
safety concern, on March 19, 2004, FDA and EPA jointly announced a consumer
advisory to limit exposure to MeHg in young children and in women who are
pregnant, nursing, or planning to become pregnant.65 The advisory recommended, for
those groups, limiting the amount and type of fish consumed to those with lower
levels of mercury, while cautioning against any consumption of shark, swordfish, king
mackerel, or tilefish because they contain high levels. The advisory also urged
limiting consumption of albacore (“white”) tuna, which has more mercury than canned
light tuna, to six ounces (one average meal) per week. Consumers were also advised
to check local fish consumption advisories, and absent advice to the contrary, to limit
consumption of locally-caught fish as well.
Critics continue to debate the proper balance of negative consumer information
about MeHg and positive messages about fish consumption. Some are calling the
advisory “insufficiently protective” of certain population groups. On June 21, 2004,
the California Attorney General filed a suit against the three largest canned tuna
companies claiming that the businesses had failed to adequately warn consumers that
albacore and light tuna may contain MeHg. In doing so, the companies had violated
California’s Proposition 65, which requires companies to provide warnings of known
64 National Academy of Sciences, “EPA’s Methylmercury Guideline Is Scientifically
Justifiable For Protecting Most Americans, But Some May Be at Risk,” press release, July
11, 2000, accompanying the report, “Toxicological Effects of Methylmercury.”
65 See [http://www.fda.gov/oc/opacom/hottopics/mercury/backgrounder.html].

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carcinogens or reproductive toxins. MeHg has been listed as a reproductive toxin in
California since 1987.
On July 6, 2004, Representative Pallone introduced the Mercury Health Advisory
Act of 2004 (H.R. 4762) to require the Secretary of HHS to ensure that the public is
provided adequate notice and education on the effects of exposure to mercury through
the development and posting of health advisories at all businesses that sell fresh,
frozen, and canned fish and seafood when the potential for mercury exposure exists.

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