Order Code IB98009
CRS Issue Brief for Congress
Received through the CRS Web
Food Safety Issues
in the 107th Congress
Updated November 7, 2001
Donna U. Vogt
Domestic Social Policy Division
Congressional Research Service ˜ The Library of Congress
MOST RECENT DEVELOPMENTS
BACKGROUND AND ANALYSIS
Public Health Problems
Federal Regulatory Framework for Food Safety
Agency Regulatory Responsibilities
Establishing Guidance and Regulatory Requirements
Enforcing Compliance with Inspections and Sanctions
Approving Food Additives and Labeling
Tracking Food-borne Illnesses
Recent Initiatives to Reduce Food-borne Illnesses
The “Farm-to-Table” Food Safety Initiative
Appropriations for Food Safety
Congressional Oversight Structure for Food Safety
Do Federal Agencies Need More Authority and Resources?
A Reorganized Regulatory Structure for Federal Food Safety?
Should Bioengineered Foods Be Labeled and Regulated?
Is Antimicrobial Resistance a Growing Public Health Problem?
Food Safety Issues in the 107th Congress
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. Food-borne illness is a
serious public health problem. Often, people
do not seek medical help and their illness is not
officially reported. Yet consumers have become aware of the serious consequences of
illnesses linked to a growing variety of foods,
produced domestically or imported. Consumers want the government to regulate the food
supply, and industry is interested in producing
foods that are safe at a reasonable price. As a
result there is congressional interest 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 for human
consumption in the United States. The Federal
Food, Drug, and Cosmetic Act (FFDCA) gives
the Food and Drug Administration (FDA) in
the Department of Health and Human Services
(DHHS) authority to set and enforce standards
for safety of all domestic and imported foods,
except for meat and poultry. FDA also ensures that all animal drugs and feeds are safe,
are labeled properly, and produce no human
health hazard when used in food-producing
animals. Also under FFDCA, the Environmental Protection Agency (EPA) sets legal limits
(tolerances) on amounts of pesticide residues
that can be found in or on food. The Federal
Meat Inspection Act and the Poultry Products
Inspection Act authorize the U.S. Department
of Agriculture (USDA) to set and enforce
standards for the safety of red meats and
and monitoring the food supply. In response to
limited federal funding, FDA and USDA
adopted an approach to food safety and inspection known as the Hazard Analysis and
Critical Control Point (HACCP) system. It
identifies where hazards could enter food
during its preparation for market and steps that
can be taken to prevent hazards.
Given concerns about the safety of the
food supply after the September 11th tragedy,
the 107th Congress is debating a number of
proposals to protect the food supply against
intentional adulteration. A few bills would
extend to FDA new authorities to register,
recall, and monitor imports. Others want to
fund more research at USDA and the National
Institutes of Health. Two bills are proposing
to consolidate into a single agency all food
safety inspection and labeling activities, now
held by several agencies.
The 107th Congress had begun considering safe food proposals prior to the tragedy
earlier this year. Congress had passed a law
(P.L. 107-9) which requires reports on interagency activities to assess, prevent, and control “mad cow disease” and foot and mouth
disease. These diseases appear on lists of
potential threats to the food supply. Other
proposals would require mandatory labeling of
country-or-origin of foods, and two would
increase the number of inspections at the
border. In appropriations’ bills, both House
and Senate have supported funding for an
emerging public health problem: antimicrobial
resistance, a growing concern as more people
are taking antibiotics prophylacticly against the
treat of anthrax infection.
The food safety activities of these agencies consist of inspecting, testing, researching,
Congressional Research Service
˜ The Library of Congress
MOST RECENT DEVELOPMENTS
Since September 11th, growing concerns in Congress about the vulnerability of the U.S.
food supply to terrorism have challenged the Administration to reexamine and in some
instances reenforce the current regulatory system. Several bills introduced in the last month
would expand FDA’s and USDA’s authorities to detain and monitor food. Most of these
proposals build on the current structure for ensuring the safety of the food supply by
expanding resources and authorities available to the agencies. Some bills call for the
federal registration of food processing and handling facilities (H.R. 3184, S. 1551), and for
each food facility to keep records to allow for the recall of unsafe food (H.R. 3075, H.R.
3127, H.R. 3184, S. 1551). Others would set up a more thorough system for monitoring the
safety of imports with more inspectors, sampling and testing, and country-of-origin labeling
(H.R. 1605, H.R. 3075, H.R. 3184, S. 1551, S. 1563). One bill proposes user fees to pay for
this activity (H.R. 3075). Two other bills would reorganize the whole federal system for food
safety to create a single food safety system (H.R. 1671, S. 1501). Other bills would
strengthen the agencies’ enforcement powers by allowing agencies to levy civil monetary
penalties when infractions are found, and would fund greater research efforts for the
development of diagnostic tests (H.R. 3075, H.R. 3174, H.R. 3184, S. 1551, S. 1563). The
Administration has proposed a more modest set of changes and wants Congress to consider
giving the Secretary of Health and Human Services authority to detain violative food if
found through inspections at the border or domestically. It would like the authority to debar
“bad actor” importers who repeatedly violate U.S. laws, require food manufacturers to keep
records that FDA officials can then inspect and copy, and have importers notify FDA prior
to importing a food. While these proposals would extend the current system, the
Administration testified October 10, 2001, that it has confidence that it could respond to
intentional terrorist threats because, in the last 4 years, it has strengthened the federal food
safety system and has now in place systems to identify and respond quickly to foodborne
illness outbreaks. In addition, the different federal agencies have worked together to put
risk-based prevention programs into place for seafood, meat, poultry, and fruit and
vegetable juices. For these reasons, some in the Administration claim that extensive new
authorities are not needed to ensure a safe food supply.
BACKGROUND AND ANALYSIS
While most experts agree that the U.S. food supply is among the safest in the world,
every year food-borne pathogens in the food supply make many people ill. Consumers have
expressed increasing concerns about microbial and other contaminants in their foods and are
asking whether the federal regulatory system adequately deals with those problems. The
nation’s food safety system consists of activities carried out by several federal, state, and local
government agencies that inspect, test, research, and monitor the food supply. For the most
part, these agencies monitor whether food manufacturers are adhering to their legal
responsibility of assuring the production of safe food. However, reported occurrences of
outbreaks of food-borne illnesses have been increasing, and current safety efforts are not
providing the confidence in the food supply that U.S. consumers demand.
In response, in 1997, the Clinton Administration launched several efforts to correct and
augment the safeguards in the food safety system with a “farm-to-table” initiative. In 1998,
this Administration finalized guidance to the industry on the production, handling, and
processing of fresh fruits and vegetables. In January 2001, the President’s Council on Food
Safety released a long-term strategic plan which recommended that Congress, rather then
creating a single food safety agency, should ensure that coordination among agencies is
strengthened, that comprehensive legislation governing food safety is rewritten, and that the
allocation of resources is based on scientific and risk-based evidence. Some claim that
reorganizing the regulatory structure for food safety would better protect the public health.
On the other hand, the food industry and some government officials have resisted proposed
changes in the food safety structure claiming that the agencies need no new authority to
enforce food safety requirements and need only to better enforce current rules.
This issue brief characterizes the public health problems caused by food-borne pathogens
and other contaminants and describes activities of federal agencies charged with ensuring that
consumers can purchase “safe” food from appropriately regulated food companies. It briefly
discusses the President’s several food safety initiatives, and describes requested resources for
federal funding and for cooperation among federal agencies involved in food safety activities.
Public Health Problems
CDC estimates that food-borne diseases cause approximately 76 million illnesses,
325,000 hospitalizations, and 5,000 deaths each year in the United States. These estimates
are based on data from a variety of sources including new surveillance systems, death
certificates, and academic studies. Experts claim that rather than any changes in disease
frequencies, better surveillance data have contributed to the increased numbers. Often, victims
mistake food poisoning for some other illness and do not report it to a doctor. Some experts
estimate that over 40 million cases of food-borne illness go unreported each year. Different
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 food-borne
pathogens. While many food-borne illnesses are mild and non-life-threatening, 1-3% of those
afflicted develop secondary complications such as reactive arthritis, kidney failure, and
Guillain Barré Syndrome — a form of acute paralysis.
Officials of the Department of Health and Human Services (DHHS) note that there has
been a 20% decrease in illnesses due to the major bacterial food pathogens. They project,
however, that the reported incidence of food-borne disease may increase by 10-15% during
the next decade. Some postulate that changes in production practices, centralized product
distribution, environmental conditions, and food consumption patterns could be contributing
to the changes in old pathogens and the emergence of new microbial threats to health.
Several factors are contributing to the concern of public health officials about the
increased risk of getting ill from food. The U.S. population is aging and there are more people
living with compromised immune systems. The highly mechanized, efficient production and
distribution practices of the food industry make it possible for a contaminated product to be
quickly distributed nationally or even internationally. Long-distance distribution channels also
give more opportunity for time and temperature abuse. With people eating out frequently,
and more retail establishments processing foods on-site, there is more opportunity for a
contaminated food to cause illness in more people. In addition, more cases of illness from
pathogenic organisms on fresh fruits and vegetables have been reported as consumers eat
more produce for its nutritional benefits.
Food-borne diseases are caused primarily by bacteria, viruses, parasites, and fungi that
produce toxic substances. There also may be long-term health effects from chemical residues
or drug residues found in food. Nonpathogenic microorganisms may become pathogenic
when they mutate or adapt to changing environments. For instance, one strain of Escherichia
coli, a common, harmless bacteria found in intestines of all birds and mammals, has mutated
into a deadly form known as E. coli O157:H7 and into other serotypes. It is now found not
only in hamburger, but also in unpasteurized apple juice, alfalfa sprouts, and packaged lettuce.
A more virulent type of Salmonella Enteritidis (SE) called phage type 4, has been found in
chickens and dairy cows. Both pathogens have contributed to the growing number of food
USDA’s estimated costs associated with medical expenses and losses in productivity
from five major types of food-borne illnesses are $6.9 billion annually (in August 2000
dollars). These major food-borne illnesses include illnesses caused by Campylobacter, E. coli
O157:H7, Shiga toxin-producing strains of E. coli, Listeria monocytogenes, and Salmonella.
Adjusting for age of death lowers or raises the cost. For example, the annual cost of food
borne illnesses caused by Salmonella decreases from $3.7 billion to $2.4 billion when adjusted
for age of death because over 2/3rds of the deaths from salmonellosis occur in people over
65. Adjusting food borne illness costs for E. coli O157:H7 by age of death increases the
estimates by $68 million because most deaths occur in children under 5.
Federal Regulatory Framework for Food Safety
The food industry makes available to U.S. consumers a wide variety of food that is
produced domestically or imported. The federal government attempts to ensure that the food
supply is safe from the farm and ports to consumer tables under statutory mandates and
regulatory policies. Federal regulatory jurisdiction depends 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 the agencies’ overlapping jurisdictions and duplication of effort are wasting taxpayers’
money. Overlapping jurisdictional responsibilities inhibit efforts to focus where the risk of
adulteration and contamination is the greatest, they claim. Federal officials, however, argue
that by working cooperatively and through formal understandings among the agencies, federal
agencies now, for the most part, avoid duplicating efforts.
Agency Regulatory Responsibilities
Federal regulatory responsibilities for food safety vary. For example, the U.S.
Department of Agriculture (USDA) regulates red meat, poultry, and certain egg products
while the Food and Drug Administration (FDA) is responsible for the safety of all other
foods. Preventing and detecting food-borne contamination is currently the job of three federal
agencies: the Food Safety Inspection Service (FSIS) and the Animal Plant Health Inspection
Service (APHIS) of USDA; two centers within FDA (an agency of DHHS) — the Center for
Food Safety and Applied Nutrition (CFSAN) and the Center for Veterinary Medicine (CVM);
and the Office of Pesticide Programs (OPP) of the Environmental Protection Agency (EPA).
In addition, the Centers for Disease Control and Prevention (CDC), also part of DHHS,
tracks food-borne illness incidents and outbreaks, and provides data and information to the
other food safety agencies. Of the illnesses whose food source is known, about 85% are
associated with food products regulated by FDA such as fish, shellfish, fruits, vegetables and
salads. The remaining 15% are associated with meat and poultry, products under FSIS’s
Even with all these federal agencies playing a role in ensuring the safety of foods,
manufacturers, producers, and distributors of food have the primary responsibility of ensuring
that the food, when marketed in interstate commerce, is not harmful or unfit and does not
contain unacceptable chemical residues. To assist in this effort, federal agencies set standards
for producers, processors, and manufacturers that minimize food hazards. Federal agencies
then enforce these standards through inspections and verification of documents.
Federal laws mandate how each federal agency approaches its role in food safety, and
these laws dictate very different approaches. The Federal Food, Drug, and Cosmetic Act
(FFDCA) prohibits the entry into interstate commerce of adulterated or misbranded foods.
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 is responsible for
establishing guidance and regulatory requirements for assuring that food is safe and not
adulterated. FDA monitors through inspections whether food manufacturers adhere to their
legal responsibility of producing foods that are not found to be defective, unsafe, filthy, or
produced under unsanitary conditions. FDA also monitors more than 3.7 million imported
food entries annually. However, as noted below, these inspections occur infrequently. FDA
also is authorized to seize contaminated food and review petitions for approval of food and
color additives, among other things.
The meat and poultry acts mandate different inspection requirements. 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 at least for part of every
shift while a firm is processing meat products for human or animal consumption. Congress
instituted similar requirements for poultry in the 1957 Poultry Products Inspection Act,
amended by the 1968 Wholesome Poultry Products Act. Under these acts, USDA is
responsible for inspecting most meat, poultry, and processed egg products for safety,
wholesomeness, and proper labeling. USDA also has established a mandatory program called
Hazard Analysis and Critical Control Point (HACCP) for meat and poultry plants.
Under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), EPA regulates
pesticide products sale and use and weighs the products costs and benefits. Under the
“safety-only” clause, Section 408 of the FFDCA, EPA sets limits for pesticide residues (called
tolerances) in or on foods and animal feed. Foods with a residue of a pesticide for which there
is no tolerance established, or with a residue level exceeding an established tolerance limit,
are declared “unsafe” and “adulterated;” such foods cannot be sold in interstate commerce
in the United States. EPA has set over 9,000 pesticide residue tolerances. FDA and USDA
enforce those tolerances on their portions of the food supply. The Food Quality Protection
Act of 1996 (P.L. 104-170) changed the so-called “zero-risk” standard of Section 409 of the
FFDCA (the Delaney Clause) so that all food, both raw and processed, have tolerances set
under a standard that requires all residues be “safe,” and ensures that there is a “reasonable
certainty of no harm” from the pesticide residues.
State, county, and local public health and agriculture departments along with the CDC
play a major role in helping FDA and USDA carry out their responsibilities. Even though
federal law mandates the safety of all food, more than 3,000 state and local regulatory
agencies monitor most retail food establishments to ensure that consumers are protected from
unsafe food and are following procedures outlined in an FDA guidance manual called the
Food Code. U.S. retail establishments include approximately 57,000 food establishments.
CDC’s primarily assists state and local health departments in investigating outbreaks of illness
and in identifying the cause of the outbreak. State health departments send CDC reports of
confirmed food-borne illnesses for a national surveillance database.
Federal agencies carry out five activities to ensure that food is safe: 1) provide guidance
to industry about what is expected, and develop policies and regulations; 2) enforce
compliance by inspections and programs; 3) give pre-market approval to additives that will
be added to food and to be listed in the labeling; 4) track food-borne illnesses in the United
States and overseas; and 5) conduct research on all phases of food science including detection
methods for contaminants.
Establishing Guidance and Regulatory Requirements. FDA promulgates
regulations and issues guidance and advisories, known as “good manufacturing practices”
(GMPs), to food manufacturers and both FDA and USDA publish regulatory requirements
which food processors must meet. Standards and requirements are developed through a
public rule-making process. In developing GMPs, for example, FDA considers a variety of
sources, including advice from international organizations. 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 address layout and maintenance of facilities, personnel qualifications,
equipment and utensils, processes and controls, and other measures required to ensure basic
sanitation and cleanliness.
FDA and USDA have adopted a preventive approach called the “Hazard Analysis and
Critical Control Point” (HACCP) program to ensure the safety of food. FDA has been using
a similar program in its low-acid canned foods regulations for more than 30 years. FDA
instituted HACCP in December 1997 for seafood products and finalized a rule on January 18,
2001, requiring HACCP for fruit and vegetable juices, except citrus juice who had already
demonstrated processing procedures to FDA that reduced contaminants sufficiently. USDA
requires HACCP for red meat and poultry. The HACCP program for food safety gained
support in 1993, when President Clinton and Vice President Gore issued a report under the
National Performance Review initiative calling for a uniform science-based approach to food
safety, and favored giving more responsibility for assuring the safety of the food supply to the
food industry. A HACCP program typically applies seven principles, based on a scientific and
technical analysis of the production process. The seven principles are (1) analyze hazards;
(2) identify critical control points to control identified hazards; (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. Once the system is in
place, FDA and USDA review the records of monitoring at the critical control points to
ensure compliance and evaluate the products and facility.
The most important and controversial step is the choice of the critical control points or
CCPs. CCPs are where control must be exercised because loss of control at a CCP is likely
to result in contamination of a food. An example of a CCP would be a heat treatment step
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. The federal government role is to give guidance, oversee safety programs, and
monitor records of those CCPs and to determine that the company corrected problems. FDA
is currently collecting information, through a voluntary pilot program, on how HACCP might
be implemented for food service and food retail establishments.
HACCP for Meat and Poultry. USDA’s final regulations for Pathogen Reduction/
HACCP in meat and poultry processing have four elements: (1) each plant had to develop
sanitation standard operating procedures (SSOPs); (2) all plants must meet performance
standards and keep records that ensure the Salmonella incidence rate is below the national
baseline level established by USDA; (3) every plant must test for the bacterium E. coli (all
strains, not specifically O157:H7) to verify that the process is controlling fecal contamination;
and (4) every meat and poultry plant must develop a critical control point under a HACCP
plan to identify where hazards occur and how to prevent them.
HACCP for Seafood. On December 18, 1997, FDA implemented HACCP regulations
for the seafood industry. Each seafood plant must have a HACCP plan available for FDA’s
review. Plant managers also must have monitoring records of its critical control points to
show whether the plan is being properly implemented. FDA is supposed to inspect all
domestic seafood processors to ensure compliance with this regulation. Critics, however,
charge that FDA has not inspected the plants on a regular basis. FDA officials state that,
although many plants need to take further action to comply with HACCP requirements, many
of the violations are minor and have no impact on the safety of the products.
Enforcing Compliance with Inspections and Sanctions. The FFDCA and
other statutes give FDA the responsibility to prohibit entry of adulterated or misbranded foods
and other products into interstate commerce. FDA regulates about 85% of food products
associated with food-borne illnesses. FDA officials (fewer than 700 and some state officials
under contract with FDA) are authorized to enter and inspect, at reasonable times, any
factory, warehouse, or establishment in which foods are manufactured, processed, packed,
or held prior to introduction into interstate commerce or in a vehicle transporting food.
Inspections of 57,000 food establishments under FDA’s jurisdiction occur on average once
every 5 years. If violations are found, FDA can request that the Justice Department initiate
an injunction, seizure, or prosecution. FDA also uses a number of administrative enforcement
tools. It sends warning letters and other regulatory correspondence, requests voluntary
recalls, creates import alert lists, detains imported foods, and prosecutes misdemeanors and
felonies through the Department of Justice. It has no power to mandate recalls or look at state
records kept by the plant. If further action is necessary, FDA requests the Department of
Justice to impound the contaminated foods.
FSIS inspectors, under the authority of the Federal Meat Inspection Act and the Poultry
Products Inspection Act, must be continuously present at all the 6,000 meat and poultry
plants while processing. FSIS inspectors (more than 7,500), who examine each meat and
poultry carcass slaughtered and are present in all meat and poultry processing plants daily,
have summary powers to withdraw their inspection services, which stops processing
operations, condemn foods, and obtain plant records. 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. It does not have mandatory recall authority. It is likely that
there will be legislation introduced into the 107th Congress that, if passed, would provide
FSIS with authority to require a recall of unsafe meat and poultry products and FDA with
recall authority over the products it regulates.
Approving Food Additives and Labeling. The FFDCA, Section 409 defines food
additives to include not only directly and indirectly added substances to foods but also certain
substances used in “producing, manufacturing, packing, processing, preparing, treating,
packaging, transporting, or holding food, and including any source of radiation intended for
any such use.” 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.” In its petition review
process, FDA determines 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 risks associated with the additives. 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).
Food Contact Substances. If FDA concludes that a substance used in
manufacturing, packing, packaging, transporting, or holding food might reasonably be
expected to migrate into the food, the substance is regulated as a “food contact substance.”
Most of the time, the risk from these substances is extremely small or de minimis. The
sponsor or manufacturer notifies the agency of the substances identity, and its intended use,
and submits all necessary information to show that the substance is safe. Unless FDA
specifically objects, the manufacturer can begin using the food contact substance. This
Premarket Notification Program (PMN) diminished the time the agency spent reviewing “food
contact substance” petitions for approval.
Food Irradiation. As shown above, the FFDCA definition of a food additive includes
the phrase “any source of radiation intended for any such use.” 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. In December 1999, USDA finalized its rule
governing the use of irradiation in raw meats and meat by-products to control disease-causing
microorganisms and to extend shelf life (64 FR 9089-9105). It extended the same rules to
poultry products. On July 20, 2000, FDA approved irradiation on eggs in shell to reduce the
level of pathogens, particularly Salmonella. The agency is currently reviewing 5 petitions that
would extend approval of the use of irradiation to ready-to-eat foods, shellfish, and processed
meats. The House report for the FY2002 agriculture appropriations bill asks FDA to meet
with stakeholders early in the process of developing petitions to irradiate foods, to speed up
the review of petitions once they are submitted, and to ensure that labeling of irradiated foods
can be understood by the general public.
Critics of irradiation are concerned that some producers, processors, and consumers will
have unrealistic assumptions about the safety of the products and, believing that their food
is safe, will not be careful with sanitary food-handling practices. Critics also say that
irradiation treatment of food kills helpful bacteria that aid digestion, may alter the nutritional
value of a food, and could cause genetic damage in animals, humans, or cell cultures.
Supporters, however, irradiation as giving the industry another “safety” tool to control foodborne pathogens. Irradiation may become a primary tool in ensuring the safety of fresh
produce such as alfalfa sprouts. The FY2001 agriculture appropriations report language
directed FDA to finalize regulations by March 1, 2002 to make the size of the label
(disclosing that a product had been subjected to ultraviolet irradiation) not larger than the
Tracking Food-borne Illnesses. In 1998, the Administration initiated PulseNet,
a system for linking electronically investigators at CDC, FDA, and USDA to public health
laboratories in 46 states (by the end of 2001.) This network of state and local laboratories is
designed to rapidly identify strains of all food-borne pathogens by matching DNA
“fingerprints” of pathogens found both in food and in people stricken with gastro-intestinal
illness. These data are collected in addition to data under FoodNet, a cooperative active
surveillance project for food-borne disease in eight targeted locations in the United States.
FoodNet, also supported by CDC, FDA, and USDA, began in 1995 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 outbreaks. Many times, when people
are diagnosed with a food-borne illness, their doctor or the laboratory that detects a
pathogenic organism in a fecal sample may or may not report the incident to the local county
health department. That department only reports periodically cases that it knows about to the
state department of health. States collect local data and send reports to CDC which updates
a national surveillance database. Preliminary data from FoodNet for 2000 indicate a decline
of 20% in food borne illnesses caused by the nine most common pathogens during 19961999. There is substantial regional and year-to-year variation in food borne illnesses.
Research. Discovery of food-borne microorganisms that have acquired pathogenic
characteristics raises concerns over whether the current food safety system is adequate to
detect and identify new pathogens and their sources before they reach consumers. In January
2001, the Clinton Administration released a Public Health Action Plan to Combat
Antimicrobial Resistance. According to the plan, the numbers and susceptibility of bacteria
that resist antibiotics are growing and the plan gives a blueprint for coordinated federal
actions to address the emerging threat of antimicrobial resistance. One goal is to increase
basic and clinical research on the physiology, genetics, and mechanisms of resistance. In fact,
the Antibiotic Resistance Prevention Act of 2001 (H.R. 1771) introduced May 9, 2001 by
Representative Sherrod Brown would provide funding for the top priority action items in this
interagency public health action plan that has been developed in response to the problem of
antimicrobial resistance. However, the bill limits the authorization to those activities involved
are within the jurisdiction of the Department of Health and Human Services.
Recent Initiatives to Reduce Food-borne Illnesses
Food-borne disease outbreaks have recently received much media attention and have
shaken public confidence in food safety. Between 1995 and 2000, over 10 food borne illness
outbreaks were associated with sprouted seeds. Since 1997, there has been a series of highly
publicized outbreaks of food-borne illness: Hepatitis A associated with frozen, sliced and
sugared strawberries from Mexico in a school lunch program, Cyclospora associated with
lettuce, basil, and Guatemalan raspberries, E. coli O157:H7 in frozen beef patties from a
packing plant, and Salmonella Agona in dry oat cereal in 11 states. In late May 2000, illnesses
caused by E. coli O157:H7, found in the city drinking water of Walkerton, Ontario, Canada,
caused 7 people to die, most of whom were aged 56 to 92. The same pathogen caused 27
cases of illness in Minnesota in November 2000, attributed to the consumption of ground beef
patties and forcing a recall of 1.1 million pounds of beef. Between May to December 2000,
29 illnesses caused by Listeria monocytogenes were identified in 10 states and linked to deli
turkey meat. Infections from Listeria causes an estimated 2,500 illnesses and 500 deaths each
year. This pathogen can lead to premature delivery or miscarriage.
The “Farm-to-Table” Food Safety Initiative
The Clinton Administration’s Food Safety Initiative, with support from the last two
Congresses, has improved the methods of tracking and preventing microbial food-borne
illnesses. A May 1997 report, entitled Food Safety From Farm to Table, laid out six major
areas for federal activity: an early warning system for food-borne disease surveillance,
coordination of response to interstate outbreaks, risk assessment, research, improved
inspections and compliance, and education. With appropriated resources, the agencies
expanded FoodNet, Pulsenet, and eLexNET, national early warning systems. The initiative
increased resources for research to develop tests that detect microbes that cause food-borne
illness, to expand inspections to improve compliance, and to support educational programs,
such as “Fight BAC,” which stresses four key points: clean hands and surfaces often; keep
hot foods hot; keep cold foods cold; separate foods and don’t cross contaminate.
Appropriations for Food Safety
For the last 4 years, both FDA and USDA have requested funding for food safety under
six categories of activities of the National Food Safety Initiative: surveillance, emergency
outbreak coordination, inspections and compliance, risk assessment, education, and research.
The Bush Administration no longer tracks funding for food safety in the same way as the
Clinton Administration. It has broadened the definition of what is included in activities related
to food safety so that food safety not only includes the prevention of microbial contamination,
but also the tracking of pesticide residues and other chemical hazards found in foods. The
broader definition also includes the entire appropriation for USDA’s Food Safety Inspection
Service (FSIS) rather than having a separate accounting for activities under the Initiative.
The Clinton Administration did not include funding for FSIS inspections under the Initiative
because these inspections included a variety of other responsibilities and were not strictly
focused on eliminating microbial pathogens in the U.S. food supply. Consequently, with
different definitions, it is impossible to compare this year’s recommended funding levels with
previous years funding levels.
For FY2002, the House passed its agriculture appropriations bill (H.R. 2330) July 11,
2001, while the Senate passed its bill (S. 1191), October 25, 2001. For FDA appropriations,
the House began its discussions with a newly defined category for “food safety” which led to
an expanded FY2001 base figure of $335.3 million. It then added $22.7 million to this base
for a total recommendation of $358 million for food safety activities in FY2002. The Senate
began with last year’s appropriations of $216.674 million, added $18.133 million, and has
now set $234.807 million for food safety activities. The difference in the increased funding
recommendation is not large; it is $4.6 million (the House with $22.7 million and the Senate,
$18.1 million). The difference in the total recommended appropriation is $123.2 million; it
is large because the Senate uses the much narrower definition. The bills are now in
Congressional Oversight Structure for Food Safety
Congressional oversight for food safety is shared among several committees. In the
Senate, food safety issues are considered by the Committees on Agriculture, Nutrition, and
Forestry; Energy and Commerce; Science, and Transportation; Environment and Public
Works; 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 Committees also serve an oversight
role in how the major agencies set and carry out policies affecting the safety of foods.
Do Federal Agencies Need More Authority and Resources?
There is a growing concern among many Members of Congress that contamination from
acts of bioterrorism that could have an impact on the safety of food animals, produce, and
imported foods. Currently under discussion in the Senate is a comprehensive bioterrorism bill
that is likely to have new authorities and funds to ensure safe food. In addition, there is
concern about whether agencies currently have adequate authority and resources to monitor
for food-borne disease problems domestically and at the border. Some in Congress would like
more resources be directed to federal agencies to prevent any contaminated food product
from entering the food chain: Food Supply Protection Act (H.R. 3174); the Agricultural
Bioterrorism Countermeasures Act of 2001 (S. 1563); and Protecting the Food Supply from
Bioterrorism (H.R. 3184, S. 1551) or from being imported into the United States (Imported
Food Safety Act of 2001, H.R. 3075 and H.R. 3184, S. 1551). Others bills (Unsafe Meat and
Poultry Recall Act of 2001, H.R. 3127; H.R. 3184, S. 1551, and S. 1563) are interested in
authorizing recall authority to allow the agencies to act quickly in response to terrorist acts
or to require more coordination among academia, industry, and government. Others are
concerned about the potential spread of Bovine Spongiform Encephalopathy (BSE) or “mad
cow disease”and foot-and-mouth disease (FMD).
A Reorganized Regulatory Structure for Federal Food Safety?
Recently, in light of the September 11th tragedy, Members of Congress are questioning
whether the current monitoring and inspection systems of USDA and FDA are capable of
safeguarding the nation’s food supply. At an October 10, 2001 hearing GAO recommended
that a single food safety agency be responsible for administering laws needed to deal with
emerging food safety issues including deliberate acts of contamination. (See GAO-02-47T,
Food Safety and Security: Fundamental Changes Needed to Ensure Safe Food.
The January 2001 strategic plan of the Council on Food Safety supported a unified
framework for food safety and laid out 3 recommendations: 1) to include risk analyses to
support decisions about reform; 2) to streamline the existing system where overlapping
jurisdictions occur; and 3) to develop a plan that addresses food safety functions that could
comply with a unified statute. There was support of a single federal official to be responsible
for federal food safety policy but not for a single agency.
Several Members of Congress are also rethinking the current organizational structure
for food safety activities within the Federal Government. Some want a single food safety
agency to undertake all food safety responsibilities as currently mandated in the statutes. The
Safe Food Act of 2001 (H.R. 1671 and S. 1501) proposes to consolidate into a single
independent agency all current responsibilities regarding food safety, labeling, and inspection
now divided among FSIS, FDA, and the Department of Commerce. It does not propose
changing the statutes that today authorize current food safety regulatory activities.
Supporters claim reorganization will address the problem of several agencies performing
food safety functions which, they assert, at times overlap and at times leave undone necessary
activities to protect the public health from food-borne illness. Supporters point to the fact
that meat pizzas must be inspected by USDA, whereas other pizzas without meat yet made
in the same plant come under FDA inspectors purview. Supporters say that a single food
safety agency can identify the most serious public health risks, respond quickly to outbreaks,
research testing methodologies, conduct risk assessments, and identify the most cost-effective
interventions without regard to the type of food or to bureaucratic “turf.” Critics of reform
believe that the time is not right for major reform because of fear that a new agency would
cause dislocation and upheaval. Parent agencies would need to relinquish their current budget
authority and control. Other opponents claim that reorganization proposals do not address
the flaws in the fundamental regulatory structure for food safety created by current statute.
Should Bioengineered Foods Be Labeled and Regulated?
Questions have been raised in the 107th Congress, 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 of living organisms. These techniques allow scientists
to identify and isolate genes of interest from any organism and put them into other organisms.
All the food safety agencies, FDA, USDA, and EPA, are involved in the regulatory process
for GE foods. EPA has recently proposed and finalized rules for GE crops that produce their
own pesticides, called Plant-Incorporated Protectants or PIPs. Currently, GE food crops
planted and marketed by U.S. farmers include 45 kinds of corn, canola, tomatoes, potatoes,
soybeans, and sunflowers. (For more information, see CRS Report RL30198, Food
Biotechnology in the United States: Science, Regulation, and Issues).
On January 18, 2001, FDA published a proposed rule, 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 agency 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 will be needed. After
reviewing the submitted data, FDA will either issue a letter to the company saying it has no
safety concerns or expressing why the product should not be marketed.
Currently, FDA does not require labeling of GE foods. However, on January 18, 2001,
FDA published in the Federal Register a “Draft Guidance for Industry: Voluntary Labeling
Indicating Whether Foods Have or Have Not Been Developed Using Bioengineering.” (It has
been reported that the agency has received over 84,000 comments on this draft guidance.) In
this document, FDA reaffirmed that it believes most genetically engineered foods are
substantially equivalent to their conventional counterparts, and it 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 “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.(See CRS Report RS20507,
Labeling of Genetically Modified Foods.)
H.R. 115, named the “Food Biotechnology Information Initiative Act,” would require
the development of a program to tell consumers about the scientific basis of the safety of
foods produced with biotechnology and provide $10 million for research to address economic
and environmental impacts of biotechnology on the food supply.
Supporters claim that GE foods have environmental benefits because there is less need
to use pesticides and farmers benefit from lower input costs. They also say these 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. These critics want mandatory
labeling and consultation with the agency prior to marketing.
Is Antimicrobial Resistance a Growing Public Health Problem?
Antimicrobials, a set of agents that include among others, antibiotics and disinfectants,
have benefitted the public health by treating diseases that were un-treatable earlier. Antibiotics
are also fed to farm animals to speed their growth, to promote the efficient use of the feed,
and they are sprayed on crops similar to pesticides. Their widespread use, particularly now
that several antibiotics are being used prophylactically against anthrax exposure, may in the
future cause some of these drugs to lose their ability to control disease, and some people to
become resistant to a number of antibiotics that are crucial for treatment of certain diseases
and infections. Although resistance to antibiotics has been noticed since they were introduced
in the 1940's, more tracking (surveillance) and publicity has recently raised concern among
some Members of Congress over this public health problem, particularly the use of antibiotics
in food animals to promote growth. Some experts expect resistance problems to worsen in
the future. (See CRS Report RL30814, Antimicrobial Resistance: An Emerging Public
Defining appropriate legislative responses is particularly difficult given the complexity
of the antimicrobial resistance problem, the lack of data to assess the problem, and the
disagreement over the seriousness of the extent of the health threat of resistance. Use of
antimicrobials in human medicine, for example, is thought to be the primary source of
resistance. Many public health officials are concerned about the trends in antibiotic use
following the scares from the threat of anthrax infection. For example, CDC has recently
urged physicians to be cautious about indiscriminately prescribing Cipro, particularly to
people who have no chance of having been exposed to anthrax, because of concerns about
the development of drug-resistant organisms.
Included in the debate are the uses of antibiotics in the agricultural sector. The conflict
there is over how much antibiotic use, both for treating disease and promoting growth, in
food-producing animals contributes to resistant strains of bacteria. A study by the Union of
Concerned Scientists, Hogging It: Estimates of Antimicrobial Abuse in Livestock, estimated
a total non-therapeutic use of 24.6 million pounds of antimicrobials in cattle, swine, and
poultry. The American Health Institute, representing drug manufacturers, has put the same
use at 17.8 million pounds. The AMA, at its annual meeting in June 17-21, 2001, passed a
resolution opposing the routine use of antimicrobial drugs in agriculture. The AMA resolution
called for increased surveillance of antimicrobial use and resistance in food animals.
On January 18, 2001, an Interagency Task Force on Antimicrobial Resistance, cochaired by CDC, FDA, and NIH, released a “Public Health Action Plan to Combat
Antimicrobial Resistance.” The Plan reflects a broad-based consensus of federal agencies1 on
what actions the government should take to combat antimicrobial resistance. The Plan
contains goals and 84 action items–13 of which are considered “top priority”:surveillance,
prevention and control, research, and product development. Each action item specifies the
coordinator, participating agencies, and timelines. It asks all federal agencies to standardize
detection methods, design and implement a national surveillance plan, and to monitor patterns
of antimicrobial drug use in human medicine, agriculture, and consumer products.
Currently, surveillance for resistance in both humans and animals is underway. However,
the surveillance of human drug use necessary to weigh which practices cause resistance is not
being conducted. This lack of use surveillance is partly due to the difficulties in collecting
such data. A system that tracked human use would require extensive linkages with
prescribing physicians, data from pharmacies, and insurance reimbursement data. For animal
use, where there is over-the-counter antibiotic use, the data is proprietary and drug companies
appear to be reluctant to share this information.
Members include: Agency for Healthcare Research and Quality (AHRQ), CDC, FDA, Health Care
Financing Administration (HCFA), NIH, and the Health Resources and Services Administration
(HRSA), several agencies of USDA, the Department of Defense (DoD), the Department of Veterans
Affairs (DVA), and the Environmental Protection Agency (EPA).
The Plan also calls for a public health education campaign to promote prudent
antimicrobial drug use. It advocates the use of vaccinations to prevent infections from
occurring in patients residing in nursing homes, among other places. It calls for the
implementation of the FDA framework for antibiotics in food animal production. It supports
research on resistance genes by public and private groups. Such research would develop
rapid diagnostic tests and novel therapies to better control resistance. It recommends the
creation of an interagency antimicrobial resistance product development working group to
identify and publicize public health needs for new products. It also calls upon the federal
government to identify incentives that can be used to promote the development of new human
and animal drugs and their judicious use.
On May 9, 2001, the Antibiotic Resistance Prevention Act of 2001 (H.R. 1771) was
introduced, which would authorize funding for the top priority action items in the interagency
public health action plan. It would only authorize activities and funding for the problems of
antimicrobial resistance within the jurisdiction of the Department of Health and Human
Services. An amendment to the FY2002 Appropriations Act requires that, of the total FDA
appropriation, $5 million be made available for carrying out the plan’s antibiotic activities.
P.L. 107-9 (S. 700)
Animal Disease Risk Assessment, Prevention, and Control Act of 2001. Directs
Secretary of Agriculture to submit a preliminary report to specified congressional committees
concerning: interagency measures to assess, prevent, and control the spread of foot and
mouth disease and bovine spongiform encephalopathy (“mad cow disease”) in the United
States; related federal information sources available to public; and the need for additional
legislative authority or product bans. Directs Secretary to submit a final report to such
committees that discusses such diseases’ economic impacts, public and animal health risks,
and related legislative authority or product bans. Introduced April 5, 2001; referred to
Committee on Agriculture, Nutrition, and Forestry. Passed Senate April 5, 2001; passed
House May 9, 2001; signed by President May 24, 2001.
H.R. 115 (Holt)
Food Biotechnology Information Initiative Act. Amends Food, Agriculture,
Conservation, and Trade Act of 1990 to provide for a program to educate public regarding
use of biotechnology in producing food for human consumption, to support additional
scientific research regarding potential economic and environmental risks and benefits of using
biotechnology to produce food, and for other purposes. Introduced January 3, 2001; referred
to Committees on Agriculture and Energy and Commerce.
H.R. 713 (Tierney)
To require Secretary of Agriculture to complete a report regarding the safety and
monitoring of genetically engineered foods, and for other purposes. Introduced February 14,
2001; referred to the House Committee on Agriculture.
H.R. 1605 (Bono)
Produce Consumers’ Right-to-Know Act. Amends the Perishable Agricultural
Commodities Act, 1930 to require retailers to provide consumers with country of origin
labeling of perishable agricultural commodities. Exempts food service establishments from
such requirement. Authorizes fines for violations of such provisions. Introduced April 26,
2001; referred to Committee on Agriculture.
H.R. 1671 (DeLauro)
To consolidate in single independent agency in executive branch responsibilities
regarding food safety, labeling, and inspection currently divided among several Federal
agencies. Introduced May 1, 2001; referred to Committee on Agriculture, Subcommittee on
Department Operations, Oversight, Nutrition and Forestry, and Subcommittee on Livestock
and Horticulture, May 14, 2001. Referred to Committee Energy and Commerce, May 1,
2001, and referred to Subcommittee on Health, May 15, 2001.
H.R. 1771 (Brown)
Antibiotic Resistance Prevention Act of 2001. To provide for funding for top priority
action items in interagency public health action plan that has been developed in response to
problem of antimicrobial resistance, to extent the activities involved are within jurisdiction of
Department of Health and Human Services. Introduced May 9, 2001; referred to Committee
on Energy and Commerce.
H.R. 1817 (Pallone)
A bill to establish comprehensive program to ensure safety of food products intended
for human consumption which are regulated by FDA. Introduced May 10, 20001; referred
to Committee on Energy and Commerce.
H.R. 2051 (Smith)
Authorizes the National Science Foundation to make grants for the establishment of
regional plant genome and gene expression research and development centers. Introduced
June 15, 2001; referred to Committee on Science, Subcommittee on Research.
H.R. 2649 (Burr)
National Uniformity for food Act of 2001. Amends the FFDCA to provide for uniform
food safety warning notification requirements, and other purposes. Introduced July 26, 2001;
referred to Committee on Energy and Commerce.
H.R. 3075 (Dingell)
Imported Food Safety Act of 2001. Amends the FFDCA to improve border inspections,
increase the number of inspections and tests of imported food, requires that imported food
have country-of-origin labeling, establishes criminal penalties for adulterating imported food,
establishes user fees to pay for additional inspections, and provides FDA with new authority
and resources to inspect and detain food. Introduced October 10, 2001; referred to
Committee on Energy and Commerce.
H.R. 3127 (Udall)
Unsafe Meat and Poultry Recall Act of 2001. Amends the Federal Meat Inspection Act
and the Poultry Products Inspection Act to authorize the Secretary of Agriculture to order
the recall of meat and poultry that is adulterated, misbranded, or otherwise unsafe. Introduced
October 12, 2001; referred to Committee on Agriculture.
H.R. 3174 (Pomeroy)
Food Supply Protection Act. Authorizes additional appropriations to combat
bioterrorism. Introduced October 25, 2001; referred to Committee on Agriculture.
H.R. 3184 (DeLauro)
Protecting the Food Supply from Bioterrorism Act. (Identical to S. 1551) Amends the
FFDCA to add provisions regarding protecting the United States food supply. Introduced
October 30, 2001; referred to House Energy and Commerce Committee.
S. 1494 (Lincoln)
Amendment to the FFDCA to limit the use of the name “catfish” in marketing of only
fish from the family Ictalariidae. Introduced October 3, 2001; referred to Committee on
Health, Education, Labor, and Pensions.
S. 1501 (Durbin)
Safe Food Act of 2001. To consolidate in a single independent Executive Branch agency
the responsibilities regarding food safety, labeling, and inspection currently divided among
several Federal agencies. Introduced October 4, 2001; referred to Committee on
Governmental Affairs. Hearing held October 10, 2001 before Subcommittee on Oversight
of Government Management, Restructuring and the District of Columbia.
S. 1546 (Roberts)
Biological Chemical Attack bill. Directs the Secretary of the Treasury to provide
funding to the Secretary of Agriculture: (1) in FY2002 for specified bio-security initiatives,
bio-safety animal research facilities, Agricultural Research Service/Animal and Plant Health
Inspection Service facilities, an animal disease laboratory, and agroterrorism rapid detection
field test kits and training; and (2) in each of FY2002 through FY2011 for specified
counter-bioterrorism research initiatives. Introduced October 15, 2001; referred to Committee
on Agriculture, Nutrition, and Forestry.
S. 1551 (Clinton)
Protecting the Food Supply from Bioterrorism Act. (Identical to H.R. 3184) Amends
the FFDCA to add provisions to register food facilities with FDA, authorize detention and
record keeping, to recall unsafe food, to strengthen import inspections through standards and
notices of import, expand food security research and surveillance, and establish education and
information systems on foodborne bioterrorism, among other things. Introduced October 15,
2001; referred to Committee on Health, Education, Labor, and Pensions.
S. 1563 (Hutchison)
Agricultural Bioterrorism Countermeasures Act of 2001. The Act would expand
research on threats of agricultural bioterrorism, promote interagency and academic
collaboration and strengthen Federal regulatory capacities to respond to a bioterrorist attack.
Introduced October 17, 2001; referred to Committee on Agriculture, Nutrition, and Forestry.