Order Code RL31853
CRS Report for Congress
Received through the CRS Web
Food Safety Issues in the 109th Congress
Updated February 4, 2005
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 109th 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 maintain that these estimates understate the problem
because many people do not seek medical help for foodborne illness and so those
episodes of illness are not included in official counts. 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 multistage 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.
Food safety issues consider food security, “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, egg safety, 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 . . . . . . . . . . . . . . . . . . . . . . 17
Other Food Safety Issues . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
Mad Cow Disease Threat . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
Enforcement Authorities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
Reorganization of the Federal Food Safety Regulatory Structure . . . . 22
Regulation and Labeling of Genetically Engineered Foods . . . . . . . . . 22
Antimicrobial Resistance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
School Meal Food Safety . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27
Safety of Fresh Produce . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29
Egg Safety . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30
Methylmercury and Fish . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30
List of Tables
Table 1. Food Safety, Security, and Defense for FY2002, FY2003,
FY2004, and FY2005 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12

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Food Safety Issues in the 109th 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, available 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, available at
[http://www.cdc.gov/mmwr/].
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, available at
[http://www.cdc.gov/mmwr/].

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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,” 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,” 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
7 “Economics of Foodborne Disease: Feature,” available 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
(continued...)

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monitors more than 5.4 million imported food entries annually at 90 ports of entry.
For this work, the agency has allocated 1,595 FTEs in FY2004.9 The agency has
increased its import examinations from 104,000 in FY2003 to 129,000 in FY2005,
due in large part to increased surveillance of imported food.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
8 (...continued)
Administration, before the Senate Committee on Governmental Affairs, Nov. 19, 2003.
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, Justification of Estimates for Appropriations Committees, Fiscal Year 2005.
11 21 U.S.C. § 321(s).

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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
USDA test and enforce those tolerances. 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. An 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 points 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
equivalent to conventional foods. The agency concluded that GE food should be
14 In December 2001, the U.S. Court of Appeals for the Fifth Circuit handed down a decision
prohibiting USDA from suspending inspections services based solely upon failure of the
salmonella performance standard. Supreme Beef Processors, Inc. v. USDA, 275 F.3d 432
(5th Cir., 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
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 109th 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 66 Federal Register 4706-4738, Jan. 18, 2001.
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, available at
[http://www.cdc.gov/mmwr/].
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, FY2004, and FY2005. Total funding for all
federal food safety activities increased 2.7% between FY2002 and FY2003, 2% from
FY2003 to FY2004, and 5.6% from FY2004 to FY2005. FSIS includes all its
20 U.S. Department of Health and Human Services, Centers for Disease Control and
Prevention, “Outbreak of Salmonella Serotype Enteritidis Infections Associated with Raw
Almonds — United States and Canada, 2003-2004,” Morbidity and Mortality Weekly
Report, vol. 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
inspection activity costs in its food safety appropriation, while 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 FDA appropriation for FY2005 for food safety and defense is $543.3
million, $35.2 million or 6.9% more than FDA’s FY2004 appropriation of $508.1
million. This increase far exceeds the 1.7% increase received in FY2003 and the
0.1% in FY2004. This total, however, is $34.6 million (6%) less than the $577.9
million requested by the President. The agency plans to use the 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.
The FSIS appropriation for FY2005 for food safety is $817.2 million, $37.3
million or 4.8% more than FSIS’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 $21.5 million (2.6%) 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 activities to coordinate the development
of infrastructure to prevent, prepare for, and respond to an intentional attack on the
U.S. food supply.22

Table 1. Food Safety, Security, and Defense for FY2002,
FY2003, FY2004, and FY2005
(in millions)
Agency
FY2002
FY2003
FY2004
FY2005a
Food and Drug
$499.0
$507.6
$508.1
$543.3
Administration
Food Safety and
$730.1
$754.8
$779.9
$817.2
Inspection Service
Total
$1,229.1
$1,262.4
$1,288.0
$1,360.5
a. With the 0.8% rescission.
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.
22 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. In fact, Tommy Thompson, the Secretary of Health and Human
Services, as he announced his resignation, expressed concern about the possibility of
a terrorist attack on the nation’s food supply by saying “For the life of me, I cannot
understand why terrorists have not attacked our food supply because it is so easy to
do!” and pointed to vulnerabilities that infected food could be imported from the
Middle East.23 Others said that the theat is equally serious for domestically produced
food and that U.S. citizens could be poisoned and not know it was intentional.24
When Congress passed the Public Health Security and Bioterrorism
Preparedness and Response Act (P.L. 107-188) on June 12, 2002, it gave FDA
further 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.25 Among other provisions, the Act required that FDA
promulgate regulations for the registration of food processors; prior notification of
proposed food imports; and the establishment and maintenance of records. FDA has
published interim final rules but has not finalized these rules. It also allowed its
inspectors to flexibly enforce the rules (FDA calls this their “transitional compliance
policy”) while establishments and traders become accustomed to the new rules.26 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 Bioterrorism Act requires all
domestic and foreign facilities that manufacture, process, pack, or hold food for
human or animal consumption in the United States to register one-time with the FDA
by December 12, 2003. FDA published an interim final rule on October 10, 2003.
The exact date for final enforcement of this requirement has been not been set but is
expected by June 2005. The registering food facility gives the agency information
about the identities (brand names) and the general food categories under which
23 Robert Pear, “U.S. Health Chief, Stepping Down, Issues Warning,” New York Times, Dec.
4, 2004.
24 Elizabeth Becker, “Shared Nightmare over the Food Supply,” New York Times, Dec. 11,
2004.
25 All four proposed rules exempt firms and products regulated exclusively by USDA.
26 U.S. Department of Health and Human Services, Public Health Service, 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].

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CRS-14
business is conducted, and the addresses of all the companies’ facilities.27 The
agency is encouraging the information be submitted electronically rather than 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). 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.
On November 8, 2004, FDA published a revised compliance policy guide for
its inspectors which also announced the full implementation of the agency’s
registration policy for domestic food facilities. For foreign facilities, the registration
requirement will be enforced through the prior notice of imported food rule.28
Prior Notice of Imported Food Shipments. The Bioterrorism Act also
required food importers give advance electronic notification prior to importation of
food.29 FDA is to be notified within no fewer than two hours of arrival of shipments
by road, four hours by air or rail, and eight hours by water of a food shipment. 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 appear to 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. 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 allows FDA and CBP to target import inspections more
27 U.S. Department of Health and Human Services, Public Health Service, Food and Drug
Administration, “Notice: Compliance Policy Guide Sec. 110.300 — ‘Registration of Food
Facilities Under the Public Health Security and Bioterrorism Preparedness and Response
Act of 2002,’ Availability,” 68 Federal Register 58894-58973, Oct. 10, 2003.
28 U.S. Department of Health and Human Services, Public Health Service, Food and Drug
Administration, “Registration of Food Facilities Under the Public Health Security and
Bioterrorism Preparedness and Response Act of 2002,” Guidance for FDA Staff,
Compliance Policy Guide, Oct. 2004.
29 U.S. Department of Health and Human Services, Public Health Service, 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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effectively, according to FDA. Critics claim that the CBP system will be overloaded
with the amount of information that will be required.
On November 8, 2004, FDA published a revised compliance policy guide on
prior notice requirements for its inspectors. It will allow inspectors temporary
discretion (until the final rule takes effect) to make enforcement adjustments when
prior notices do not contain all the required information. This enforcement flexibility
will allow for the food industry to adjust to the requirements before the final prior
notice rule will be published in June 2005. For those shipments allowed entry
thereafter, 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.
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.
Establishment and Maintenance of Records. The Act also requires the
FDA to promulgate rules requiring food manufacturing establishments (which must
register) to keep production and distribution records. On December 6, 2004, FDA
published final regulations and issued draft guidance to FDA inspectors and the food
industry detailing how the agency will request the records.30 Companies will be
required to make the records available within 24 hours if the FDA has a reasonable
belief that an article of food presents a serious threat. Under this final rule, FDA
inspectors would have access to all processing, packing, transporting, receiving,
holding, importing, and distribution records (including lot, code number, or other
identifier if the information exists) 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 rule also will
permit access to the firm’s records kept to comply with other “federal, state, or local
laws or as a matter of business practice.” It requires companies to keep the required
information from 6 months to 2 years depending on the shelf life of the food. The
rule also allows firms to keep the information in any form that they prefer (i.e., paper
or electronic) and use existing records to satisfy the requirements. All but small
firms must comply within 12 months. Small businesses (under 499 employees) have
18 months to comply, and very small businesses (under 10 employees) have 24
months.

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
30 U.S. Department of Health and Human Services, Public Health Service, Food and Drug
Administration, “Establishment and Maintenance of Records Under the Public Health
Security and Bioterrorism Preparedness and Response Act of 2002; Final Rules and Notice,
21 CFR Parts 1 and 11,” 69 Federal Register 71562-71655, Dec. 9, 2004. See also
[http://www.fda.gov/bbs/topics/news/2004/NEW01143.html].

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general context of protecting the public health. The rule 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
reemphasizes in instructions to agency 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.
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 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 should have required
information, within 24 hours after purchase, the sources and recipients of ingredients
at the most precise level possible.
Administrative Detention. On June 4, 2004, FDA finalized its rule on
administrative detention — the authority to detain food imports or hold them in place
— under certain conditions. Although this authority came into effect immediately
upon the Bioterrorism law’s signing, so far FDA has not used it. In the final rule,
FDA described the “credible evidence” needed to prove that a food presents a threat
of serious adverse health consequences or death to humans or animals.31 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
31 U.S. Department of Health and Human Services, Public Health Service, 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;
Final Rule,” 69 Federal Register 31659, June 4, 2004.

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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.32 The
agencies are also developing common 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 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.33 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
32 See [http://www.dhs.gov/dhspublic/interapp/press_release/press_release_0453.xml].
33 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 multidepartment,
multiagency national effort is an attempt to minimize disruption of economic activity and
travel. FDA News, Mar. 19, 2003, pp. 3-18.

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agent. Extensive testing revealed no problems, and the tip was a hoax. Several
agencies, the Coast Guard, FDA, USDA, and the state of New Jersey, were involved
in handling this situation.
On January 14, 2005, FDA announced a new Office of Food Safety, Defense,
and Outreach, combining many of the education and outreach activities with
counterrorism activities. In 2003, USDA had set up a special Office for Food
Security and Emergency Preparedness. Both offices increased the agencies’
surveillance and ability to test for pathogens related to bioterrorist threats. Both
agencies 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 Bureau of Directorate, Customs and Border
Protection, the Federal Bureau of Investigation, and other agencies involved in food
safety.34
Neither FDA nor USDA has the authority to impose security requirements on
a food processing facility. A February 2003 GAO report had defined “outside”
security activities for food establishments as physical precautions: perimeter fences,
guards, alarms, outside lighting, background checks on employees, and restricted
access for movement within food facilities.35 GAO concluded that neither agency
could assess the industries’ efforts to prevent or reduce their vulnerability to
deliberate contamination because they could not require baseline data on security
measures currently in place. The GAO report also concluded that employees in food
facilities had not been trained to respond if there were a threat.36
In part to assist industry with ensuring its safety, in January 2005 USDA created
a self-assessment check-list for food processing establishments to assess the extent
to which they have a secure establishment.
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.
34 See CRS Report RL32521, Agroterrorism: Threats and Preparedness, by Jim Monke.
35 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.
36 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.

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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.37
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
announced that 99% are complying with the 1997 ban.38 Additional safeguards have
been added through import restrictions and BSE surveillance.
When BSE was found in the United States, on December 30, 2003, the then-
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.39
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
37 See CRS Issue Brief IB10082, Meat and Poultry Inspection Issues, by Geoffrey S. Becker;
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 Geoffrey S. Becker and Sarah
Lister.
38 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/Newsroom/0451.03.html].
39 U.S. Department of Agriculture, Food Safety and Inspection Service, news release, “USDA
Issues New Regulations to Address BSE,” Jan. 8, 2004, at [http://www.fsis.usda.gov/
oa/news/2004/bseregs.htm].

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CRS-20
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.
In March 2004, the Secretary of Agriculture, referring to the recommendations
of the Advisory Committee, announced details for an expanded surveillance effort
for BSE.40 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 220,000 animals, a ten-fold increase over prior annual surveillance efforts.
Since the expanded testing began in June 2004, about 121,000 cattle have been
tested. This fall, three animals have yielded positive or “inconclusive” findings on
screening tests but were all found to be negative for BSE on the confirmatory tests.
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.
Some argue that the 220,000 testing goal is still insufficient to ensure the safety of
the meat supply.
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.41 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)42 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. There has been no further action as of December 2004. 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
40 U.S. Department of Agriculture, “Veneman Announces Expanded BSE Surveillance
Program,” Press Release No. 0105.04, Mar. 15, 2004.
41 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.
42 69 Federal Register 42288, July 14, 2004.

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CRS-21
FDA has not delivered on its January 2004 promise to prohibit blood and blood
products, poultry litter,43 and restaurant plate waste as feed ingredients for ruminants,
and should have finalized these measures.44
On January 4, 2005, USDA published a final rule that will permit the import of
Canadian cattle under 30 months of age, among other commodities, effective March
7. However, some in Congress have protested this implementation citing in part the
fact that Canada announced on January 2, 2005, it had a second case of BSE, in a
dairy cow born before a 1997 ban on feeding most ruminant material to ruminants.
Then on January 11, 2005, Canada announced a third BSE case found in a beef cow
born in March 1998, after the feed ban was implemented. Canada has pledged to
review the feed bans’ effectiveness.(See CRS Issue Brief IB10127, Mad Cow
Disease: Agricultural Issues for Congress, by Geoff Becker).
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
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. 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.
Language in the FY2005 agricultural appropriations conference agreement
requires both FSIS and FDA now list all their recall press releases the website
address of the manufacturer of the recalled product, if any, and, if it would assist
consumers and the media in identification of the product, a photograph of the recalled
product or label.
43 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
one an 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.
44 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-22
In previous Congresses, bills were introduced to require mandatory notification
of the regulatory agency when a federally inspected establishment believes that its
food product was adulterated or misbranded, and issues a recall of the product. In
addition, other bills would have given 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.45
Reorganization of the Federal Food Safety Regulatory Structure.
For many decades there has been a debate about the effectiveness of the federal
regulatory structure for food safety 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. In the 108th Congress, the Safe Food Act
of 2004 (H.R. 5259 [DeLauro] and its companion bill S. 2910 [Durbin]) was
introduced on October 7, 2004. This bill would have placed several centers and
functions of USDA, FDA, the Department of Commerce, and EPA together in a
single Food Safety Administration. To be moved from USDA would have been FSIS,
the shell eggs surveillance services of AMS, and the food safety and animal feed
research of the Research, Education, and Economics area. To be moved from FDA
would have been CFSAN, CVM, the functions of the Office of Regulatory Affairs
(ORA) related to inspections of food establishments and imports, and the resources
and facilities of the FDA Commissioner’s office for CFSAN, CVM, and ORA. The
seafood inspection program of the Department of Commerce’s National Marine
Fisheries Service (NMFS) and EPA’s resources and facilities used to control and
regulate pesticide resides in foods would have moved to the new entity. 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, and increasing levels of food imports. They maintain that a
single agency would result in a more consistent and efficient system for regulating
food. It would eliminate, for example, the inefficiences of FDA inspecting the
cheese pizza and USDA inspecting the meat pizza in the same establishment.
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.
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
45 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-23
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.46 Other GE food crops planted and
marketed by U.S. farmers include canola, tomatoes, potatoes, papaya, squash, and
sunflowers.47
On January 18, 2001, FDA published a proposed rule,48 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.
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
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.49
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
46 See CRS Report RS21381, Adoption of Genetically Modified Agricultural Products, by
Geoffrey S. Becker (out of print: available from author: 7-7287).
47 For more information, see CRS Report RL30198, Food Biotechnology in the United
States: Science, Regulation, and Issues, by Donna U. Vogt and Mickey Parrish.
48 66 Federal Register 4706, Jan. 18, 2001.
49 See CRS Report RS20507, Labeling of Genetically Modified Foods, by Donna U. Vogt.

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CRS-24
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.50 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.51
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.52 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.
On November 8, 2004, the Secretariat of the North American Commission for
Environmental Cooperation (CEC) released a report titled Maize and Biodiversity:
The Effects of Transgenic Maize in Mexico. Prepared under a side-agreement of the
North American Free Trade Agreement, this report looked at how Mexico could
preserve its corn biodiversity. GM corn had spread through cross-pollination with
local varieties. It is illegal to plant and grow GM corn anywhere in Mexico, although
50 68 Federal Register 11337, Mar. 10, 2003.
51 See CRS Report RS21418, Regulation of Plant-Based Pharmaceuticals, by Geoffrey S.
Becker and Donna Vogt.
52 National Academy of Sciences, National Research Council, Safety of Genetically
Engineered Foods: Approaches to Assessing Unintended Health Effects (Washington:
National Academies Press, July 28, 2004).

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CRS-25
it can legally be consumed as food. The report recommended much greater
surveillance of cross-pollination in plants by the Mexican government and long-term
testing to ensure safety. It also recommended that all imported U.S. corn be milled
at the border. USTR and EPA called the report “flawed and unscientific” in a press
release, saying it failed to consider the benefits of biotechnology and contained no
economic analysis of its recommendations.
Also in November 2004, FDA published a draft guidance describing procedures
that it recommends be used to assess the safety of new proteins in plant varieties
intended for food. The draft addresses the potential of a new protein to cause an
allergic reaction in susceptible people or be toxic to people or animals. The agency
is recommending that sponsors of new food plant varieties consult with FDA prior
to when the plant protein might be planted and inadvertently enter the food supply.53
Under the proposal, developers would provide FDA with information about the food
safety of the new protein at a relatively early stage of development of the crop. Once
a developer decides to commercialize a particular crop, the developer would still be
expected to participate in FDA’s voluntary premarket consultation process. The
agency also stated that any potential risk from the low-level presence of GM material
in the food supply would be limited to the possibility that it would contain or consist
of a new protein that might be an allergen or toxin. Critics of the draft complain that
it is vague, fails to specify when safety evaluations must be submitted, what toxins
and allergens should be evaluated, and whether crops can be planted while FDA
assesses their safety.54
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.55
Although antimicrobial agents are used to treat illnesses both in humans and
animals, these agents are also used in food animals for nontherapeutic purposes.
53 See [http://www.cfsan.fda.gov/~dms/bioprgui.html].
54 “FDA Guidance on Early Safety-Evaluation of Biotech Food Lacks Detail,” Inside Health
Policy, Nov. 29, 2004.
55 Associated Press, “Drug-Resistant Bacteria Spread in France,” New York Times, Dec. 11,
2003.

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CRS-26
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
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.
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.56 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.
56 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
Following the review process of Guidance #152, an FDA animal health advisory
board decided, in October 2004, that a new macrolide antibiotic, Draxxin
(tulthromycin), had a low risk of contributing to antimicrobial resistance in humans
and could be used in food animals. The drug is injected into swine and cattle to treat
their respiratory disease. Critics are concerned that this board did not apply the risk-
assessment finding to all uses of macrolides in animal agriculture. Other critics
expressed concern that the risk assessment took over a year to complete.
In the 108th Congress one bill, the Preservation of Antibiotics for Medical
Treatment Act of 2003 would have provided for a phased elimination of the routine
feeding to food-producing animals the same antimicrobial drugs also used in humans.
The bill would have required that manufacturers show that their nontherapeutic use
in food animals does not pose a threat to public health. The bill would have allowed
therapeutic use of the drugs to treat sick animals and pets. In addition, the bill would
have required manufacturers of antimicrobial drugs used routinely in animal feed to
report annual sales information. Supporters claim that scientific experts have shown
that the overuse of antibiotics in human 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.57 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.
On November 24, 2004, FDA published a draft risk assessment of the
streptogramin-class animal drug virginiamycin, used to promote growth and to
prevent or control disease in chickens, turkeys, swine, and cattle. It estimates a low
risk of humans acquiring a resistant bacterial infection that could be resistant to
Synercid, a human drug chemically similar to virginiamycin.
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
57 65 Federal Register 64954, Oct. 31, 2000.

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CRS-28
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
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, identical bills, the Safe School Food Act
of 2003 (S. 506 and H.R. 1551), which would have amended 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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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) increased the number of required food safety inspections
(from a minimum of once-a-year to twice-a year), required that reports on recent
inspections be publicly available, mandated that states and the USDA “audit” the
inspection reports, and added 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 that it expects to offer, on a voluntary basis, irradiated
ground beef to schools in January/February 2005. The majority of ground beef used
in these feeding programs is provided by USDA. In response to this provision, bills
were introduced in the 108th Congress 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.58 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. In fact, CDC estimates that about 12% of foodborne-
outbreak associated illnesses were lined 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.
On October 18, 2004, FDA released its 2004 Produce Safety Action Plan. It has
four general objectives: (1) prevent contamination of produce; (2) minimize health
impact when produce gets contaminated; (3) educate producers, preparers, and
consumers about handling produce; and (4) support research. Critics were pleased to
see that the agency added ways to measure the plan’s impact; its draft plan, published
58 U.S. Department of Health and Human Services, Centers for Disease Control and
Prevention, “Hepatitis A Outbreak Associated with Green Onions at a Restaurant —
Monaca, Pennsylvania, 2003,” Morbidity and Mortality Weekly Report, vol. 52, no. 47,
Nov. 28, 2003, pp. 1155-1157.

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in June 2004, did not. (See CRS Report RL32746, Fruits, Vegetables, and Other
Specialty Crops: A Primer on Government Programs, by Jean Rawson.
Egg Safety. On September 22, 2004, FDA published a proposed rule on the
prevention of Salmonella Enteritidis (SE) in shell eggs.59 CDC data show that the
incidence of SE illnesses has remained steady for the past several years. FDA is
proposing that producers test the environment for SE in poultry houses. If found, the
eggs are to be diverted to locations where liquid eggs can be pasteurized or used in
other processed products. In addition, the proposed rule requires that a designated
person on each farm administer the prevention measures and keep records of testing.
Large producers (more than 3,000 laying hens) will have to treat eggs to get a
100,000-fold reduction in SE organisms. The proposal does not cover producers with
fewer than 3,000 hens. It also would require a pest and rodent control program, the
cleaning and disinfection of poultry houses that test positive for SE, and refrigerated
(below 45 degrees Fahrenheit) storage of eggs at the farm, among other things.
Industry claims that it is already following many of the recommendations and that
with proper storage and cooking most of the risks of SE are eliminated.
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 recreational caught fish. Many states also monitor the safety of fish within
their borders and issue consumption advisories for recreational-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 Sciences 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.”60 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
59 U.S. Department of Health and Human Services, Public Health Service, Food and Drug
Administration, “Prevention of Salmonella Enteritidis in Shell Eggs During Production;
Proposed Rule, 21 CFR Parts 16 and 118,” 69 Federal Register 56823-56906, Sept. 22,
2004, pp..
60 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.”

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advisory to limit exposure to MeHg in young children and in women who are
pregnant, nursing, or planning to become pregnant.61 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
carcinogens or reproductive toxins. MeHg has been listed as a reproductive toxin in
California since 1987.
On November 5, 2004, CDC summarized results of its 1999-2002 National
Health and Nutrition Examination Survey (NHANES). Although it found that blood
Hg levels in most young children and women of childbearing age were below levels
of concern, approximately 6% of childbearing-aged women had levels at or above a
reference dose, an estimated level assumed to be without appreciable harm.
Therefore, CDC recommended that women who are pregnant or who intend to become
pregnant should follow federal and state advisories on consumption of fish.62 Critics,
however, are vocal in their concerns about the neurological effect of mercury. The
Environmental Working Group (EWG) released its own year-long report on December
13, 2004. The report reviewed a study suggesting that some autistic children may
have a metabolic abnormality that would make them more susceptible to the effects
of toxins such as mercury. The EWG wants the federal government to do more to
control MeHg levels in fish.63
61 [http://www.fda.gov/oc/opacom/hottopics/mercury/backgrounder.html]
62 See the specific issue at [http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5343a5.htm].
63 See the EWG report at [http://www.ewg.org/reports/autism/execsumm.php].

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