Food Safety: Changes Needed to Minimize Unsafe Chemicals in Food (Chapter
Report, 09/26/94, GAO/RCED-94-192).
GAO identified five basic weaknesses in the overall federal structure
and systems for monitoring chemicals in food. First, fragmentation of
responsibility among multiple agencies results in inefficiencies and
gaps in federal monitoring activities. Second, chemicals posing similar
risks may be regulated differently under different laws. Third, federal
agencies rely on programs to detect unsafe chemicals in food rather than
preventing these problems from developing. Fourth, agencies lack strong
enforcement authorities to adequately deter or penalize violators.
Fifth, similar problems exist for imported foods, over which the United
States has even less control. GAO summarized this report and
GAO/RCED-94-158 in testimony before Congress; see: Food Safety:
Fundamental Changes Needed to Improve Monitoring of Unsafe Chemicals in
Food, by John W. Harman, Director of Food and Agriculture Issues, before
the Subcommittee on Human Resources and Intergovernmental Relations,
House Committee on Government Operations. GAO/T-RCED-94-311, Sept. 28,
1994 (seven pages).
--------------------------- Indexing Terms -----------------------------
REPORTNUM: RCED-94-192
TITLE: Food Safety: Changes Needed to Minimize Unsafe Chemicals in
Food
DATE: 09/26/94
SUBJECT: Food inspection
Food and drug law
Contaminated foods
Product safety
Health hazards
Consumer protection
Import regulation
Food supply
Agricultural products
Toxic substances
IDENTIFIER: USDA Coordinated Pesticide Data Program
USDA National Residue Program
HNIS Nationwide Food Consumption Survey
USDA Continuing Survey of Food Intakes by Individuals
Dept. of Commerce Seafood Contamination Risk Information
System
FSIS Hazard Analysis and Critical Control Point System
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Cover
================================================================ COVER
Report to the Chairman, Human Resources and Intergovernmental
Relations Subcommittee, Committee on Government Operations, House of
Representatives
September 1994
FOOD SAFETY - CHANGES NEEDED TO
MINIMIZE UNSAFE CHEMICALS IN FOOD
GAO/RCED-94-192
Minimizing Unsafe Chemicals in Foods
Abbreviations
=============================================================== ABBREV
AMS - Agricultural Marketing Service
CFSAN - Center for Food Safety and Applied Nutrition
CVM - Center for Veterinary Medicine
CWA - Clean Water Act
EPA - Environmental Protection Agency
FDA - Food and Drug Administration
FFDCA - Federal Food, Drug, and Cosmetic Act
FGIS - Federal Grain Inspection Service
FIFRA - Federal Insecticide, Fungicide, and Rodenticide Act
FMIA - Federal Meat Inspection Act
FSIS - Food Safety and Inspection Service
HACCP - Hazard Analysis and Critical Control Point
NAS - National Academy of Sciences
NASS - National Agricultural Statistics Service
NMFS - National Marine Fisheries Service
NRP - National Residue Program
OIG - Office of Inspector General
PDP - Pesticide Data Program
PMIA - Pesticide Monitoring Improvements Act
PPIA - Poultry Products Inspection Act
TSCA - Toxic Substances Control Act
USDA - U.S. Department of Agriculture
Letter
=============================================================== LETTER
B-257040
September 26, 1994
The Honorable Edolphus Towns
Chairman, Human Resources and
Intergovernmental Relations
Subcommittee
Committee on Government Operations
House of Representatives
Dear Mr. Chairman:
This report examines the underlying causes of deficiencies in the
federal government's programs to ensure that food does not include
harmful chemical residues. We are recommending that the Congress
take actions to fundamentally change the federal approach to
monitoring chemicals in food to increase the effectiveness of federal
programs to prevent and control unsafe chemicals in food.
As agreed with your office, unless you publicly announce its contents
earlier, we plan no further distribution of this report until 7 days
from the date of this letter. At that time, we will send copies of
this report to other appropriate congressional committees and
subcommittees; the Secretary of Agriculture; the Secretary of Health
and Human Services; the Administrator, Environmental Protection
Agency; the Commissioner, Food and Drug Administration; the Secretary
of Commerce; the Director, Office of Management and Budget; and other
interested parties. We will also make copies available to others on
request.
This work was performed under the direction of John W. Harman,
Director, Food and Agriculture Issues, who can be reached on (202)
512-5138. Other major contributors to this report are listed in
appendix VIII.
Sincerely yours,
Keith O. Fultz
Assistant Comptroller General
EXECUTIVE SUMMARY
============================================================ Chapter 0
PURPOSE
---------------------------------------------------------- Chapter 0:1
Although the use of chemicals has helped to improve the quality and
quantity of the U.S. food supply, concerns remain about the health
implications of chemical residues in food. Over the last two
decades, GAO and others have reported recurring problems in the
federal government's programs to ensure that only safe chemicals are
approved for and used in food production. GAO undertook this review
to determine the underlying causes of the deficiencies in the current
system. Specifically, this report addresses four issues pertaining
to the federal government's efforts to monitor chemicals in food:
(1) the methodologies and data used to identify chemical risks, (2)
the legal and regulatory structure, (3) the federal enforcement
processes, and (4) the safety of imported foods. Because of an
ongoing interest in food safety issues, the Chairman, Human Resources
and Intergovernmental Relations Subcommittee, House Committee on
Government Operations, asked GAO to report its findings to the
Subcommittee.
BACKGROUND
---------------------------------------------------------- Chapter 0:2
Potentially unsafe chemicals may enter the food supply from a variety
of sources, including chemical residues and environmental
contaminants. Chemical residues may occur in food from the use of
pesticides, animal drugs, and food additives. Food-use chemicals
must be approved by a federal agency before they can be used legally
in the United States. A food may legally contain a number of
chemical residues as long as they are within allowable levels
(tolerances). Environmental contaminants (such as lead and mercury),
unlike chemical residues, are not intentionally used in food
production but enter the food supply because they occur in the
environment, naturally or as a result of pollution. The
responsibility for monitoring chemical residues and environmental
contaminants in domestic and imported food is fragmented. The
primary responsibility rests with the Food and Drug Administration
(FDA), the U.S. Department of Agriculture (USDA), and the
Environmental Protection Agency (EPA). These responsibilities are
imposed by a variety of laws that provide federal agencies with the
authority to (1) approve food-use chemicals before they can be used,
(2) sample and test food products to ensure their safety (end-product
testing), and (3) take regulatory actions when violations occur.
Federal agencies spend about $150 million annually to monitor
chemicals in food.
RESULTS IN BRIEF
---------------------------------------------------------- Chapter 0:3
Fundamental weaknesses exist in the federal programs to monitor
chemicals in food. Because of fragmented responsibility, federal
efforts to assess the risks posed by chemicals are inconsistent.
Also, chemicals posing similar risks may be regulated differently
under different laws. Moreover, illegal residues in food are often
not detected because of the weak federal enforcement system, which
relies principally on end-product testing and interagency referrals
for action against identified violations. Finally, the problems we
have identified for domestic foods are also relevant for imported
products. A unified federal system for monitoring chemicals in food
would overcome many of the structural weaknesses identified.
PRINCIPAL FINDINGS
---------------------------------------------------------- Chapter 0:4
IDENTIFYING UNSAFE CHEMICALS
-------------------------------------------------------- Chapter 0:4.1
Federal agencies responsible for ensuring that food is safe from
harmful chemicals do not assess risk in the same way; as a result,
they may arrive at different risk estimates for the same chemical.
This inconsistency raises questions about the reliability of
agencies' decisions on which chemicals and what levels of chemicals
may be in food. These decisions are also debatable because they may
be made without essential information on food consumption and actual
chemical levels in foods.
AGENCIES' EFFORTS TO REDUCE
RISKS
-------------------------------------------------------- Chapter 0:4.2
Different standards in the laws regulating the approval and use of
chemicals in food present several problems in ensuring that the
safety net for food is intact. Because of these problems, chemicals
posing similar risks may be regulated differently under different
laws. Also, federal law does not generally require agencies to
periodically reevaluate compounds approved in the past against the
most current scientific standards. Moreover, unapproved and
potentially hazardous chemicals may be in food because agencies'
emergency use provisions have resulted in the long-term, widespread
use of these compounds. Finally, while about 60,000 industrial
chemicals are used in the United States and have some potential to
enter the food supply through air, water, and soil pollution, no food
safety law specifically requires federal agencies to monitor
environmental contaminants in food.
FEDERAL ENFORCEMENT
MECHANISMS
-------------------------------------------------------- Chapter 0:4.3
Federal agencies' current enforcement mechanisms--end-product testing
and interagency referrals--cannot detect and prevent contaminated
food products from entering the food supply and do not effectively
penalize violators and deter future violations. End-product testing
requires extensive resources to (1) obtain comprehensive information
on chemicals in use for all products and (2) develop test methods to
detect all chemicals of concern. However, agencies have limited
resources that cannot adequately satisfy the needs of end-product
testing. To overcome the limitations of end-product testing, some
sectors of the food industry have developed and adopted a new
approach--Hazard Analysis and Critical Control Point--that better
ensures safety and quality from the very start of food production.
This new approach is based on the principle of identifying and
controlling hazards at critical points throughout the production
process. While federal agencies have begun to acknowledge the
relevance of this new approach, they have put into place only a few
such programs. However, even if end-product testing is replaced by
this new approach, FDA will still lack adequate enforcement tools,
such as detention of food products and civil penalty authorities.
CHEMICALS IN IMPORTED FOODS
-------------------------------------------------------- Chapter 0:4.4
Because federal agencies have less control over imported foods than
over domestic foods, ensuring the safety of these products is often
more problematic. Although meat and poultry can be imported only
from countries with equivalent inspection systems, no such
requirement is in place for other types of food products. As a
result, the federal government has limited assurance that many of
these imported products have been adequately inspected in the country
of origin. Moreover, federal resources to test imported foods have
not kept pace with their growing volume. Even the testing that does
occur cannot ensure that the most critical compounds of concern are
examined because (1) agencies often lack data on the chemicals used
in exporting countries and (2) some import-testing programs focus
only on domestic compounds of concern. Finally, as with domestic
food products, FDA lacks the authority to effectively deter or
prosecute violators.
RECOMMENDATIONS TO THE CONGRESS
---------------------------------------------------------- Chapter 0:5
Because the problems associated with the current fragmented system
cannot be solved by individual agencies' efforts, the Congress
should, at a minimum, take steps to (1) enact uniform food safety
laws that resolve differences in chemical standards and provide
agencies with adequate oversight authorities and (2) direct agencies
to develop systems that prevent, rather than simply identify,
chemical problems. The Congress should also consider requiring that
all foods eligible for import be produced under equivalent food
safety systems, as is required for meat and poultry. Ideally, as GAO
has stated in the past, food safety would be better ensured if the
Congress created a single agency responsible for carrying out the
requirements of a cohesive set of food safety laws.
AGENCY COMMENTS
---------------------------------------------------------- Chapter 0:6
GAO received comments on a draft of this report from USDA, the
Department of Commerce, EPA, and FDA. USDA generally concurred with
GAO's conclusions and recommendations. The Department of Commerce
did not fully agree with GAO's conclusions and believes that better
interagency coordination can rectify the deficiencies of the current
system; however, it agreed with GAO's recommendations. EPA disagreed
with GAO's recommendation on the need for a single food safety agency
and suggested the creation of an interagency council. However, GAO
disagrees that improved interagency coordination can resolve all of
the inefficiencies of the current system or the problems caused by
inconsistent legislation. FDA did not concur with the report and
stated that the information contained in the report is outdated and
does not support the conclusions and recommendations. GAO disagrees
with FDA's comments. The widespread recognition of the problems with
the current system is evidenced by over 90 reports that GAO and
others have issued over the past 20 years. Many of the problems
identified in this review were compiled from reports issued between
1990 and 1994, and only the most current available program-specific
data were used. Furthermore, as GAO has stated in this report and in
the past, the imbalances in the current regulatory system are
primarily the result of the fragmented legal structure that divides
responsibility among multiple federal agencies. This fragmentation
has resulted in gaps and duplication in federal food monitoring
activities. GAO believes that a unified food safety system that
allocates resources according to the greatest human health threats is
needed.
All four agencies suggested several technical revisions that have
been incorporated in the report. (See apps. IV through VII for the
full text of the comments received from each agency and GAO's
specific responses.) GAO also contacted organizations that represent
various sectors of the food industry, to obtain their views on the
effectiveness of the current federal system and alternative
approaches to improve it. The views of these officials have been
incorporated in the report.
INTRODUCTION
============================================================ Chapter 1
The success of U.S. agriculture is, to an important degree,
attributable to the effective use of chemicals that have improved
both the quantity and quality of the nation's food supply. However,
this heavy reliance on chemicals raises many concerns about the
presence of unsafe chemicals in food and their potential threat to
human health. Although chemical hazards generally fall below
biological hazards when ranked in importance as public health issues,
the long-term and chronic effects of these hazards represent an
important public health concern. Moreover, consumers perceive the
risks from chemical contamination in food as their major food safety
concern. For example, a 1993 nationwide poll found that almost 70
percent of Americans were very concerned about the health effects on
young children of chemicals used to grow food. Similarly, a 1994
study reported that residues, such as pesticides and herbicides,
continued to be rated as the preeminent health hazard by 72 percent
of those surveyed, and antibiotics and hormones in meat and poultry
were considered a serious health hazard by 50 percent of those
surveyed.\1
--------------------
\1 Trends in The United States: Consumer Attitudes and the
Supermarket 1994 (Food Marketing Institute, Washington, D.C.).
SOURCES OF CHEMICAL RESIDUES
AND ENVIRONMENTAL CONTAMINANTS
IN FOODS
---------------------------------------------------------- Chapter 1:1
Potentially unsafe chemicals can enter the food supply from a variety
of sources, including chemical residues and environmental
contaminants. Chemical residues can result in food from the use of
pesticides, animal drugs, and chemical additives during food
production. These chemicals must be approved by a federal agency
before they can be legally used in the United States. If a chemical
leaves a residue in food, the cognizant agency is responsible for
establishing a tolerance level--the amount of residue that can
legally remain in or on raw and processed foods.\2
A food may legally contain a variety of chemical residues as long as
they are within allowable levels. Some chemical residues in excess
of their tolerance levels may have serious health consequences for
consumers. For example, some pesticides may cause cancer, and some
animal drugs may produce allergic reactions in sensitive persons.
Environmental contaminants are another source of potentially unsafe
chemicals that can enter the food supply. Unlike chemical residues,
these chemicals are not intentionally used in food production but
enter the food supply through their occurrence in the environment.
Pesticides (including herbicides, insecticides, rodenticides,
fungicides, nematicides, acaracides, disinfectants, fumigants, and
plant growth regulators) are used widely for both agricultural and
nonagricultural purposes in the United States. Pesticides kill or
control undesired insects, weeds, rodents, fungi, bacteria, or other
organisms. Approximately 440 pesticides (active ingredients) have
been registered for use on food and animal feed in the United States.
Every year the Environmental Protection Agency (EPA) approves between
10 and 15 new pesticides for use in the United States. In 1991, an
estimated 817 million pounds of pesticides (active ingredients)
valued at over $6 billion were used for agricultural application.
Animal drugs, including prescription drugs dispensed by licensed
veterinarians, nonprescription (over-the-counter) drugs, medicated
feeds, and veterinary medical devices, are used to treat a large
percentage of U.S. livestock and poultry for therapeutic,
reproductive, and production purposes. Animal drugs may be used in
more than one species and are often administered to whole herds or
flocks. In 1993, 748 animal drugs had been approved for use on
food-producing animals in the United States. Every year the Food and
Drug Administration (FDA) approves about 17 new drugs for use in
food-producing animals. In 1992, sales of animal health products
were estimated at $2.3 billion.
Environmental contaminants are chemicals that either occur in the
environment naturally or are introduced into the environment in the
form of air, water, or soil pollution. Some chemicals, such as
mercury and lead, naturally occur at trace levels in the environment,
and some, such as selenium, may in fact be essential nutrients at
these levels, but when they concentrate at higher levels--for
example, because of pollution or groundwater contamination--they may
become a public health concern. In addition, the improper or illegal
disposal of industrial wastes may result in water and soil pollution,
and industrial emissions may result in dangerous air-borne elements
that may also be absorbed into food produced in polluted areas. Over
60,000 industrial chemicals are used in the United States.
--------------------
\2 Some chemicals may have a zero tolerance level, and therefore no
residues of the chemical are allowed in food, while others may not
require a tolerance.
FEDERAL APPROACH TO MONITORING
CHEMICALS IN FOOD
---------------------------------------------------------- Chapter 1:2
Monitoring chemical residues in food can generally be divided into
three broad phases.\3 The initial phase involves approving a chemical
for use and setting acceptable levels of that chemical's residues
(tolerances) in food. The federal agencies' decisions to approve a
chemical and set tolerances for it are based on (1) an analysis of
the available scientific data and (2) a determination that the
chemical does not present a risk above acceptable levels to human
health and/or the environment (see chs. 2 and 3). The second phase
involves sampling and testing the food supply to ensure that it is
free from illegal residues. Illegal residues include those of
approved chemicals that exceed their established tolerance levels or
any unapproved or banned chemicals. The final phase of federal food
monitoring involves enforcement activities, when violative residues
are discovered. These activities are designed to identify the cause
of contamination and ensure that future violations do not occur (see
ch. 4). A number of federal agencies, in cooperation with state
agencies, are responsible for implementing the government's program
to monitor chemical residues in food. These federal and state
responsibilities are discussed in greater detail below.
Federal agencies do not monitor environmental contaminants in the
same way that they monitor chemical residues. The difference exists
because unlike chemical residues, environmental chemicals are not
intentionally added to food and therefore do not have to receive a
pre-market clearance like other food-use chemicals. As a result,
tolerances are set and the food supply is sampled and tested for
environmental contaminants only when a public health concern arises.
(This issue is discussed in greater detail in ch. 3.)
--------------------
\3 For this report, we defined "monitoring" in its broadest sense to
denote any activity conducted by a federal agency that has an impact
on ensuring that food is free of chemical contamination. This
includes, among other things, pre-market reviews and evaluations of
chemicals, food sample collection, laboratory analysis of food
samples, follow-up on violations of chemical use, enforcement
actions, and research and development activities.
MULTIPLE FEDERAL AGENCIES
ARE RESPONSIBLE FOR
MONITORING CHEMICAL RESIDUES
AND ENVIRONMENTAL
CONTAMINANTS IN FOODS
-------------------------------------------------------- Chapter 1:2.1
The responsibility for monitoring chemical residues and environmental
contaminants in food is split among many different agencies. Primary
responsibility rests with FDA, in the Department of Health and Human
Services; several agencies in the U.S. Department of Agriculture
(USDA); and EPA. In addition, the National Marine Fisheries Service
provides a voluntary fee-for-service inspection program for fish
products. These responsibilities are imposed by a variety of laws
designed to (1) ensure that food-use chemicals receive a pre-market
review by a federal agency before they are legally marketed and used
in the United States, (2) provide federal agencies with oversight
authority to sample and test products to ensure that they are not
contaminated with chemical residues and/or environmental
contaminants, and (3) provide federal agencies with the authority to
take regulatory actions when a contaminated food product or
chemical-use violation is detected. Because the laws divide the
authority and responsibility for monitoring chemicals in food among
various agencies, one agency may be responsible for approving a
chemical's use, while a second agency may be responsible for
monitoring the presence of that chemical's residue in the food
supply. Furthermore, state agencies may be ultimately responsible
for taking regulatory enforcement action for misuse of the chemical.
The federal government spends about $157 million annually to monitor
chemical residues and environmental contaminants in food. (Table 1.1
provides an overview of the responsibilities of various food safety
agencies and the laws that regulate them, and table 1.2 is a list of
funds allocated by the primary agencies for monitoring chemicals in
food.)
Table 1.1
The Federal Chemical Residue and
Environmental Contaminants Monitoring
System
Animal drug Environmental
Pesticide residues residues contaminants
------------------ ------------------ ------------------ --------------------
Chemical may occur All foods--raw and Meat, poultry, All foods--raw and
in processed, eggs, seafood, and processed, imported
imported and dairy products, and domestic--and in
domestic--and in both imported and drinking water
drinking water domestic
Principal laws Federal Federal Food, Federal Food, Drug,
Insecticide, Drug, and and Cosmetics Act;
Fungicide, and Cosmetics Act; Federal Insecticide,
Rodenticide Act; Federal Meat Fungicide, and
Federal Food, Inspection Act; Rodenticide Act;
Drug, and Cosmetic Poultry Products Toxic Substances
Act; Federal Meat Inspection Act; Control Act; Clean
Inspection Act; Egg Products Water Act; Federal
Poultry Products Inspection Act Meat Inspection Act;
Inspection Act; Poultry Products
Egg Products Inspection Act; Safe
Inspection Act; Drinking Water Act
Pesticide
Monitoring
Improvements Act
Pre-market Yes Yes No
approval required
for use on food?
Agency responsible Environmental Food and Drug Food and Drug
for setting Protection Agency Administration Administration for
tolerances or food and the
standards Environmental
Protection Agency
for water quality
Agency responsible Department of Department of Department of
for testing food Agriculture for Agriculture for Agriculture for
for chemicals meat, poultry, and meat, poultry, and meat, poultry, and
egg products; Food egg products; Food egg products; Food
and Drug and Drug and Drug
Administration for Administration for Administration for
all other foods all other foods all other foods
Agency with Environmental Food and Drug Environmental
enforcement Protection Agency Administration in Protection Agency
authority to in cooperation cooperation with
ensure proper use with state state agencies
of chemicals agencies
--------------------------------------------------------------------------------
Table 1.2
Estimated Expenditures by Primary
Federal Agencies on Monitoring Chemicals
in Food, Fiscal Year 1993
Planne
d
expend
itures
for
fiscal
year
Primary department/agency 1993
------------------------------------------------------------------------ ------
U.S. Department of Agriculture
--------------------------------------------------------------------------------
Food Safety and Inspection Service $28,53
4,000
Federal Grain Inspection Service 200,50
0
Agricultural Marketing Service (Dairy Division) 25,000
Agricultural Marketing Service (Science Division) 190,00
0
Agricultural Marketing Service (Poultry Division) 22,000
Agricultural Marketing Service (Pesticide Data Program) 11,563
,000
Agricultural Research Service 23,700
,000
National Agricultural Statistics Service (Pesticide Usage 3,500,
Data) 000
Department of Commerce
--------------------------------------------------------------------------------
National Marine Fisheries Service 1,475,
000
Food and Drug Administration
--------------------------------------------------------------------------------
All Centers 63,615
,000
Environmental Protection Agency
--------------------------------------------------------------------------------
Office of Water 595,00
0
Office of Pesticide Programs 3,908,
000
Office of Research and Development 19,700
,000\a
================================================================================
Total $157,0
27,500
--------------------------------------------------------------------------------
\a This amount includes estimated expenditures on drinking water
safety.
FOOD AND DRUG
ADMINISTRATION
------------------------------------------------------ Chapter 1:2.1.1
FDA is the primary federal regulatory agency for ensuring the safety
of all domestic and imported foods, excluding meat and poultry, and
some egg products. It carries out its responsibilities primarily
under the Federal Food, Drug, and Cosmetic Act (FFDCA), as amended,
and is responsible for enforcing the provisions of the act. FDA is
also responsible for carrying out the provisions of the Pesticide
Monitoring Improvements Act (PMIA).
The FFDCA is designed to ensure that food sold in interstate
commerce, including imported food, is safe, sanitary, wholesome, and
properly labeled. The FFDCA requires FDA to control foods
adulterated by added substances as well as those occurring naturally.
The FFDCA also regulates pesticides, food and color additives, and
new animal drugs. The act requires (1) the establishment of a
maximum acceptable level of pesticide residues in food and animal
feed and (2) pre-market approval for food and color additives, new
animal drugs, and additives to animal feed. Under FFDCA, foods are
considered adulterated if they contain pesticides, animal drugs, or
other chemical residues above established tolerance levels.
To implement FFDCA, FDA (1) enforces pesticide residue tolerances for
a wide variety of raw agricultural and processed foods, and animal
feeds; (2) ensures that environmental contaminants in food and animal
feed are within safe levels; (3) regulates the use of animal drugs,
including approving new animal drugs and enforcing their proper use.
To address the first two objectives, FDA monitors foods by sampling
and testing domestic and imported products under its various
compliance programs to determine whether they contain chemical
residues and/or environmental contaminants above the established
tolerance levels. FDA's Center for Food Safety and Applied Nutrition
(CFSAN) is responsible for developing and overseeing the regulation
and enforcement of the food safety, quality, and labeling
requirements of the FFDCA. Relevant CFSAN activities include
developing analytical methods for measuring residues in foods,
determining the incidence and level of occurrence of pesticides and
chemical contaminants in food, carrying out field-monitoring programs
for selected contaminants, and taking regulatory action as
appropriate.
For the third objective, FDA's Center for Veterinary Medicine (CVM)
is responsible for approving, regulating, and ensuring the safety of
animal drugs and livestock feeds marketed in interstate commerce.
CVM's two major projects are (1) the pre-approval evaluation of new
animal drugs and food additives to ensure that they are safe and
effective for their intended use and (2) the monitoring of animal
drugs, feeds, and medical devices marketed in interstate commerce to
ensure that they are safe and effective, and not adulterated or
misbranded, and that harmful residues do not enter the human food
supply.
Under the PMIA, FDA also (1) develops data management systems to
track, summarize, and evaluate pesticide-monitoring data, (2) enters
into cooperative agreements with foreign countries to obtain
pesticide usage data in these countries for crops exported to the
United States, and (3) develops a plan to guide the development of
methods to improve the efficiency of food monitoring.
DEPARTMENT OF AGRICULTURE
------------------------------------------------------ Chapter 1:2.1.2
Several agencies within USDA have programs that monitor chemical
residues and environmental contaminants in foods--primarily in meat,
poultry, and egg products. The Food Safety and Inspection Service
(FSIS) is responsible for ensuring that meat and poultry products
sold for human consumption are safe and wholesome and properly
marked, labeled, and packaged. FSIS operates under the authorities
of the Federal Meat Inspection Act (FMIA), as amended, and the
Poultry Products Inspection Act (PPIA), as amended. These laws were
enacted to ensure that domestic and imported meat and poultry
products are wholesome and properly labeled. Generally, the acts
prohibit adulteration and misbranding of meat and poultry products
and require FSIS to perform antemortem and postmortem inspections of
meat and poultry sold in interstate commerce as well as inspections
of slaughter and processing facilities for sanitation. Under the
acts, adulterated meat and poultry products include those that
contain poisonous or deleterious substances that may render the
product injurious to health. These include pesticides, animal drug
residues, and environmental contaminants above established
tolerances. The FMIA and PPIA also require that imported meat and
poultry be produced under inspection systems that are at least equal
to that of the United States. Imported products must meet
inspection, sanitary, quality, species verification, and residue
standards applied to domestic meat and poultry.
The Agricultural Marketing Service (AMS) has similar responsibilities
for eggs under the Egg Products Inspection Act, as amended. AMS
inspects egg product processing plants and firms marketing eggs to
ensure that egg products are wholesome, unadulterated, and truthfully
labeled. Inspections of egg products include chemical residue tests
for various industrial and environmental contaminants, trace
elements, and drug residues.
Other USDA agencies with chemical residue monitoring responsibilities
include the Federal Grain Inspection Service (FGIS) and the National
Agricultural Statistics Service (NASS). FGIS is responsible for
ensuring that U.S. grain for export and domestic consumption is safe
and of high quality. FGIS' current chemical residue monitoring
activities include testing grains for about 19 pesticide residues.
NASS, in conjunction with AMS, monitors chemical residues in foods
through the Pesticide Data Program. Under the Pesticide Data
Program, AMS collects statistically valid information on some
pesticide residues in certain fruits and vegetables, and NASS
collects data from farmers on their pesticide use on fruits,
vegetables, nuts, and field crops.
Two other agencies within USDA, the Agricultural Research Service and
the Cooperative State Research Service, are also involved in
providing research support to USDA. Their activities primarily focus
on developing new, rapid, and improved analytical test methods to
detect harmful chemicals in food.
ENVIRONMENTAL PROTECTION
AGENCY
------------------------------------------------------ Chapter 1:2.1.3
EPA's primary responsibilities for chemical residues and
environmental contaminants in food are to (1) register pesticides for
use in the United States after ensuring that their use will not cause
an unreasonable risk to the environment or people; (2) establish the
legal maximum level of pesticide residues allowed in each specific
food or animal feed product for those pesticides that will leave a
residue; and (3) obtain information on industrial chemical effects
and for chemicals that present an unreasonable risk to people and the
environment, take steps to control their manufacturing, processing,
distribution, use, and disposal. EPA has no direct responsibility to
enforce pesticide residue or environmental contaminant levels in
food. Therefore, the agency conducts only limited monitoring of
pesticides and industrial chemicals in food as part of its monitoring
of these contaminants in the environment.
EPA conducts its pesticide registrations under the authority of the
Federal Insecticide, Fungicide, and Rodenticide Act, as amended
(FIFRA). The act requires the registration of pesticides with EPA
before they can be marketed for use in the United States. EPA is
also authorized to specify the terms and conditions of use and remove
unreasonably hazardous pesticides from the marketplace. The act
requires EPA to take into account the economic, social, and
environmental costs and benefits in making decisions about pesticide
usage.
EPA is also responsible for establishing the criteria used by the
states to develop water quality standards. Although water quality
standards are only indirectly linked to food safety, some of EPA's
responsibilities directly affect the safety of seafood and freshwater
fish, especially fish consumed intrastate and not covered by FDA
under the FFDCA. One of the important environmental laws that affect
water quality and seafood that EPA administers is the Clean Water
Act. Under the Clean Water Act, as amended, EPA has the authority to
set water quality standards with the objective of restoring and
maintaining the integrity of the nation's waters and protecting and
propagating fish, shellfish, and wildlife. EPA is also responsible
for regulating and establishing enforcement standards for
contaminants in drinking water under the Safe Drinking Water Act.
In addition, under the Toxic Substances Control Act (TSCA), EPA is
responsible for reviewing and maintaining an inventory of industrial
chemicals that may pose an unreasonable risk to health and the
environment and can be used in the United States. TSCA was enacted
to provide a safeguard against the introduction of additional
contaminants into the environment and to address the risks posed by
existing ones. Under this act, EPA may require chemical
manufacturers and processors to test potentially harmful chemicals
for the purpose of assessing their health and environmental effects.
EPA has the authority to ban or restrict the use of chemicals that
pose an unreasonable risk. In addition, EPA can issue advisories to
warn the public of chemical dangers.
NATIONAL MARINE FISHERIES
SERVICE
------------------------------------------------------ Chapter 1:2.1.4
The National Marine Fisheries Service (NMFS), of the National Oceanic
and Atmospheric Administration, within the Department of Commerce,
conducts a voluntary seafood inspection program that includes
inspection of seafood processing plants, fishing vessels, and seafood
products for microbial and chemical contamination. Because FDA has
regulatory responsibility for ensuring seafood safety, it set up an
Office of Seafood in 1991 to cooperate with NMFS in overseeing
seafood inspections. NMFS applies FDA's standards during its
voluntary inspections of seafood and seafood processing plants. NMFS
also administers a Product Quality and Safety Research Program that
conducts research on issues affecting the optimum use of living
marine resources. The safety efforts of this research program
address concerns about the impact of environmentally and
process-induced contamination of seafood on consumers and the fishing
industry.
FEDERAL-STATE COOPERATIVE
AGREEMENTS
-------------------------------------------------------- Chapter 1:2.2
A number of food safety programs are also administered by the states
in cooperation with federal agencies.\4 For example, FDA has a
memorandum of understanding with the National Conference on
Interstate Milk Shipments (a voluntary organization of state
officials), under which the states are allowed to carry out most of
the monitoring, enforcement, and other regulatory functions to ensure
the safety and wholesomeness of fresh milk and cream in the United
States. This organization is also responsible for testing milk and
cream for animal drug residues. FDA also has a cooperative program
with many states to ensure the safety and sanitation of shellfish,
which includes testing the quality of water where shellfish are
harvested for known or suspected contaminants. In addition, FDA
contracts with the states to obtain assistance in inspecting food
firms that are under FDA's jurisdiction. Some of these contracts
include programs to monitor pesticide residues in foods, drug
residues in edible animal tissue, and toxins in shellfish.
To help conduct their programs, EPA, FSIS, and NMFS also have
cooperative arrangements with various state agencies. For example,
EPA has cooperative agreements with states and Indian tribes for
enforcing pesticide-use violations and for training and certifying
those who apply pesticides; FSIS has a federal-state cooperative
inspection program in which FSIS monitors state inspection programs
for meat and poultry that will be sold only in intrastate commerce;
and NMFS has cooperative agreements with some states to perform
voluntary inspection services for seafood products, which NMFS
oversees.
--------------------
\4 The primary focus of this report is on the monitoring activities
of federal agencies, not the activities of state agencies. However,
because many federal programs rely on cooperation with the state
agencies, where appropriate, references have been included to
identify the role of the states in ensuring that the food supply is
safe from chemical residues and environmental contaminants.
PROBLEMS WITH FEDERAL
MONITORING OF CHEMICALS IN FOOD
HAVE BEEN WIDELY RECOGNIZED
---------------------------------------------------------- Chapter 1:3
Problems with federal efforts to monitor chemical contamination in
food have been identified for decades in many previous reports by GAO
and others. Over the years, federal agencies have been unsuccessful
in completely addressing the many specific problems identified by
GAO, the Offices of Inspector General, the Office of Technology
Assessment, the National Academy of Sciences, and others.
Since the 1970s, GAO and others have issued about 90 reports that
have identified systemic problems that question the effectiveness of
the federal system to monitor chemical contamination in food. (See
app. III for related reports by GAO and others.) The significant
problems that we have identified in the past cover a host of issues,
such as the lack of interagency coordination and cooperation, the
limitations associated with end-product testing, limited sampling and
program coverage, and the ineffective use of deterrents to prevent
future occurrences. The National Academy of Sciences, the Office of
Technology Assessment, and the Offices of Inspector General have also
raised similar concerns about various aspects of the system.
In response to such criticisms, the responsible federal agencies have
implemented numerous corrective actions to improve program
operations. However, while some problems have been resolved, many
are as significant today as they were in the 1970s and continue to
weaken the system. For example, in 1978 we identified major concerns
with EPA's special pesticide registration provisions. In particular,
we noted that EPA has allowed the extensive and recurrent use of
unapproved pesticides under its emergency pesticide exemption
provisions. We questioned the emergency nature of many of these
special exemptions and reported that this practice may allow
pesticides of unknown safety to be used over long periods of time
(see ch. 3). When we revisited these issues in 1981 and again in
1991, we found that problems still persisted.\5 Similarly, in 1979 we
identified problems with USDA's ability to prevent the distribution
to U.S. consumers of meat and poultry containing harmful chemical
residues.\6 In 1985, the National Academy of Sciences found that
while USDA had taken some corrective actions, improvements were still
needed. Between 1986 and 1991, USDA's Office of Inspector General
also issued a series of reports on this same issue and found that
program improvements were still needed. This year, we again reported
that USDA's National Residue Program continues to suffer from many of
the problems identified in 1979 (see ch. 4).\7
--------------------
\5 Special Pesticide Registration by the Environmental Protection
Agency Should Be Improved (CED-78-9, Jan. 9, 1978); Stronger
Enforcement Needed Against Misuse of Pesticides (CED-82-5, Oct. 15,
1981); Pesticides: EPA's Repeat Emergency Exemptions May Provide
Potential for Abuse (GAO/T-RCED-91-83, July 23, 1991).
\6 Problems in Preventing the Marketing of Raw Meat and Poultry
Containing Potentially Harmful Residues (HRD-79-10, Apr. 17, 1979).
\7 Food Safety: USDA's Role Under the National Residue Program
Should Be Reevaluated (RCED-94-158, Sept. 26, 1994).
OBJECTIVES, SCOPE, AND
METHODOLOGY
---------------------------------------------------------- Chapter 1:4
Given the widespread recognition of problems with the federal system
to monitor chemical residues and environmental contaminants in food,
we sought to identify the underlying causes for deficiencies in the
current system. This report addresses the (1) methodologies and data
used to identify risk, (2) legal and regulatory structure, (3)
federal enforcement processes, and (4) safety of imported foods.
Because of his ongoing interest in food safety issues the Chairman,
Human Resources and Intergovernmental Relations Subcommittee, House
Committee on Government Operations, requested that we report our
results to the Subcommittee.
To obtain information on the federal requirements in place to control
chemical residues and environmental contaminants in food, we reviewed
pertinent laws and regulations. To obtain information on
deficiencies identified in the past, we obtained and reviewed about
90 reports by GAO, the Congressional Research Service, the Office of
Technology Assessment, the Offices of Inspector General, the National
Academy of Sciences, and others. To obtain information on the
corrective actions taken over time and the current status of various
aspects of federal chemical residue and environmental contaminants
monitoring programs, we obtained documents and interviewed officials
at the Food and Drug Administration; the U.S. Department of
Agriculture's Agricultural Marketing Service, Agricultural Research
Service, Food Safety and Inspection Service, Federal Grain Inspection
Service, Human Nutrition Information Service, and National
Agricultural Statistics Service; the Environmental Protection Agency;
and the National Marine Fisheries Service. We also obtained
information on industry programs through trade journals and
conferences as well as from trade associations, such as the National
Turkey Federation and the Animal Health Institute. To obtain an
industry perspective on the adequacy of the current federal system
and alternative approaches to monitoring chemicals in food, we
interviewed officials at the American Meat Institute, Food Marketing
Institute, National Broiler Council, National Fisheries Institute,
and the National Food Processors Association.
We conducted our review between January 1993 and July 1994, in
accordance with generally accepted government auditing standards.
INCONSISTENT METHODOLOGIES AND
INCOMPLETE DATA IMPEDE
IDENTIFICATION OF CHEMICALS POSING
RISK
============================================================ Chapter 2
To identify chemicals that pose a risk to human health in food,
federal agencies rely on risk assessments. Although risk assessments
are inherently uncertain, federal agencies compound this uncertainty.
First, they employ inconsistent methodologies that may produce
different estimates of risk for the same compound. Second, the
agencies often lack essential data, such as current food consumption
patterns and actual residue levels in food.
DIFFERENCES IN AGENCIES'
METHODOLOGIES CAUSE VARIATIONS
IN CHEMICAL RISK ESTIMATES
---------------------------------------------------------- Chapter 2:1
Risk assessment--the use of factual information to define the health
effects of exposure of individuals or populations to hazardous
chemicals or situations--is inherently uncertain. (See app. I for a
detailed discussion of the risk assessment process.) But problems
with how federal agencies conduct risk assessments exacerbate the
uncertainties and leave open to debate the results of risk
assessments. Specifically, because agencies lack uniform guidelines,
risk assessments for the same chemical may vary from agency to
agency.
In assessing federal agencies' risk assessment efforts, in 1983 the
National Academy of Sciences (NAS) concluded that "agency guidelines
[governing risk assessment methodologies] have varied markedly in
form and content. Without a deliberate coordinating effort, there is
no reason to assume that guidelines will become more nearly uniform."
The report went on to conclude that uniform guidelines are feasible
and desirable for federal agencies conducting risk assessments.
Despite this recommendation, differences in methodology persist
between agencies. For example, when extrapolating the results of
animal studies to humans for carcinogenic risk assessments, EPA and
FDA use different cross-species scaling factors.\1 This difference in
methodology is one of the chief causes of variation among estimates
of a chemical's potential human risk, even when the assessments are
based on the same data. EPA's cross-species scaling factor relates
the data on metabolic rates and toxicity to body surface area, while
FDA's approach relates these data to average body weight. According
to FDA and EPA officials, EPA's method provides a more conservative
risk assessment than FDA's and may result in differences in estimates
between the two agencies by a factor of as high as 10. An
interagency work group was established to address this difference.
Although no final action had been taken as of July 1994, this work
group's draft report, published in the Federal Register in June 1992,
provides a unified approach for the agencies to use when
extrapolating results from animal studies to humans. This new
approach combines aspects of both EPA's and FDA's strategies.
Similarly, the agencies apply different methodologies to determine
how the high doses administered to animals in laboratory tests
correlate to the low doses that humans may be exposed to. Because
humans are not exposed to the high levels of chemicals used in
laboratory experiments, federal agencies must determine how the
animal test data correlate to human dietary exposure. However, the
differences in low-dose extrapolation methods between agencies may
result in different low-dose estimates of a chemical for the same
level of risk, according to an FDA official. For example, EPA's and
FDA's low-dose extrapolations for a given chemical at a given level
of risk may vary by a factor as much as 2.
Finally, some agencies balance benefits and risks in determining
whether to approve a chemical compound as part of their regulatory
responsibility, while others do not. As a result, decisions about a
chemical's safety may also vary between agencies.
--------------------
\1 Scaling is the mathematical process used to adjust the dosage of
chemicals administered to one size or species of animals to achieve
comparable effects in another size or species of animals.
AGENCIES' DECISIONS ARE OFTEN
BASED ON INCOMPLETE HUMAN
EXPOSURE DATA
---------------------------------------------------------- Chapter 2:2
The uncertainty in the risk assessment process is further compounded
by the federal government's lack of crucial data, such as the types
and levels of food consumed by American consumers and the chemical
residues in food. Even the data collected often cannot be used by
multiple agencies, or within the same agency, because of limitations
in federal data management practices. As a result, the agencies'
decisions on chemical approval and use may not be as informed as they
need to be.
DESPITE NUMEROUS PROGRAMS,
AGENCIES LACK ADEQUATE DATA
-------------------------------------------------------- Chapter 2:2.1
Despite ongoing programs to collect reliable and accurate data, some
of the data elements critical to the risk assessment process are not
available to federal agencies. For example, to estimate human
dietary exposure to chemicals, the agencies need, among other things,
accurate food consumption data for the general population and
subpopulations, as well as reliable data on chemical residue and
environmental contaminant levels in food. The quality of exposure
estimates is directly linked to the quality of both of these data
sets. However, quality data for both sets are generally unavailable
because the cognizant agencies lack a coordinated strategy to collect
these data.
For example, USDA is responsible for collecting food consumption data
through its Nationwide Food Consumption Survey--a household and
individual food intake survey conducted every 10 years. However,
USDA's last survey, conducted in 1987-88, was so flawed that federal
agencies were unable to use the information collected, according to
FDA and EPA officials. Consequently, federal agencies have had to
base their exposure assessments on the results of USDA's 1977-78
survey, which cannot provide current and accurate food consumption
patterns for the national population. According to USDA officials,
the agency is trying to overcome its data collection problems. But
until it does so, FDA and EPA officials told us that their risk
assessments are not as definitive as they could be.
Moreover, when determining exposure to chemical residues and
environmental contaminants, federal agencies must consider the
differences in the levels of consumption of food by certain
subpopulations. These subpopulations may be at greater risk to some
chemical residues because of differences in their dietary patterns.
However, neither the Nationwide Food Consumption Surveys nor USDA's
new Continuing Survey of Food Intake of Individuals adequately
represents the food consumption patterns of subpopulations or special
food classes, such as seafood consumption, according to agency
officials. We and others have in the past identified the lack of
adequate consumption data on subpopulations--such as infants and
children and pregnant women--as a critical deficiency in the federal
risk assessment process. Agency officials told us that inadequate
resources constrain their efforts to collect these essential data
elements. Similarly, the federal government lacks data on
consumption patterns for special food items like seafood and ethnic
foods, which are consumed in larger quantities than the national
average by some subgroups. Officials from EPA, FDA, and the National
Marine Fisheries Service told us that no comprehensive or reliable
national seafood consumption survey has been conducted since the
1970s. As a result, the agencies often have to make inferences on
consumption levels from a variety of information sources that may be
inconsistent, may have collected data at different times, and may
have used different methodologies.
In commenting on a draft copy of this report, the Department of
Commerce told us that to overcome the lack of data on consumption and
contaminants in seafood, it is developing a Seafood Contamination
Risk Information System that will incorporate data on contaminants in
and consumption of seafood.
To assess human exposure, the agencies also need reliable data on the
actual level of chemical residues in food. Without such data,
agencies such as EPA have to assume that residues will occur in food
at the maximum level, which may not realistically represent the
actual residues consumed.\2 Although FDA and USDA have ongoing
programs to collect data on residues in food, they can provide EPA
with statistically valid data for only about a dozen fruits and
vegetables and for only a limited number of pesticides. Not only has
the fragmentation of food safety responsibility led to such gaps in
data, but it has also resulted in duplicate federal data collection
programs. USDA and FDA are both spending over $35 million annually
to collect pesticide residue information that may be duplicative. In
1992 we reported that USDA's Pesticide Data Program (PDP), which
collects statistically based data on fruits and vegetables, may be
duplicating the efforts of FDA's pesticide surveillance activities.\3
EPA officials who use the PDP information for pesticide regulatory
decisions believe that the USDA data has filled a void that could not
be filled by either FDA's surveillance and compliance programs or the
Total Diet Study Program.
Although both USDA and FDA, in commenting on a draft of this report,
deny any duplication in their programs, citing differences in their
objectives and missions, we continue to question the need for two
separate federal efforts for collecting pesticide residue data on
fruits and vegetables. We are especially concerned because FDA has
recently started its own pilot program to collect statistically based
residue data, as well. Under this pilot program, FDA is conducting
statistically based testing of selected fruits and vegetables at an
estimated cost of $1 million per commodity per year, according to
agency officials. These officials told us that the data from the
pilot program will provide a basis for comparison and allow them to
determine if any significant differences exist in the results of
their nonstatistically based surveillance sampling and their
statistically valid sampling. We question why, in June 1992, FDA
implemented sampling and testing under this pilot effort without
first comparing its surveillance residue data with the PDP residue
data available from USDA. FDA officials could not provide us with
any rationale for continuing with their pilot program beyond the fact
that they had committed to this effort long before USDA's PDP was
implemented.
--------------------
\2 In its comments on a draft of this report, EPA stated that when
maximum residue levels are used for risk assessment and result in a
determination that the risk is acceptable, then no value is added by
obtaining actual residue data. Therefore, using maximum residue
levels as a "first cut" in the dietary risk assessment process may
minimize the generation of unnecessary data.
\3 Food Safety: USDA Data Program Not Supporting Critical Pesticide
Decisions (GAO/IMTEC-92-11, Jan. 31, 1992).
INADEQUATE FEDERAL DATA
MANAGEMENT PRACTICES FURTHER
LIMIT DATA'S USEFULNESS
-------------------------------------------------------- Chapter 2:2.2
Generally, federal agencies' data management practices limit the
usefulness of the extensive amounts of data that they do collect.
Neither EPA nor FDA has designed or managed information systems to
promote access to and/or use of the available data. For example, we
reported in November 1992 that EPA has had difficulty in identifying
needed information from pesticide data that may be scattered
throughout its various data management systems or kept in paper
files.\4 Consequently, EPA cannot develop a comprehensive and
reliable profile of a given pesticide's review status. After 3 years
of effort and $14 million invested in a system to track the pesticide
reregistration process, EPA still could not easily assemble accurate,
reliable, and complete information on chemicals in the reregistration
process. These problems largely result from inadequate system
planning and poor data management practices. We concluded that
compiling information about pesticides undergoing reregistration
remains difficult, labor-intensive, and time-consuming.
Without reasonable access to data, a regulatory agency may be unable
to respond effectively in an emergency situation. For example, when
a hazardous pesticide--metam-sodium--spilled into the Sacramento
River in the summer of 1991, EPA was not even aware that it had
received information that the pesticide metam- sodium could cause
birth defects.\5 Because it lacked adequate tracking and data
management systems, EPA had not identified, reviewed, or acted upon
relevant studies and therefore could not issue appropriate warnings
to pregnant women and others at risk. Although we did not review the
adequacy of EPA's actions, the agency has taken steps to prevent such
incidents from occurring in the future.
We found similar problems with FDA's data management and information
systems. In January 1992, we reported that because of weaknesses in
FDA's management information system for inspection data on new animal
drugs, FDA reviewers and management could not obtain reliable and
adequate inspection information to assist in approving new animal
drugs or in efficiently allocating limited inspection resources.\6
The data in FDA's data base were inconsistent and incomplete, and the
agency lacked formal policies and procedures to ensure the
reliability of the information in this data base. Similarly, in its
1991 report on FDA,\7 the Advisory Committee on the Food and Drug
Administration (also known as the Edwards Committee) stated that
deficiencies in the agency's information systems were "acutely
apparent, and FDA has frequently been unable to respond in a timely
fashion to the most fundamental questions from Committee members.
Some responses to the most basic questions had to be tabulated
manually." Furthermore, the Committee stated that FDA's current
management information systems preclude the effective use of
available resources and that fundamental changes are critical.
Although FDA recognizes the need for better management information
systems, because of resource constraints, the agency has been unable
to develop such systems.
--------------------
\4 Pesticides: Information Systems Improvements Essential for EPA's
Reregistration Efforts (GAO/IMTEC-93-5, Nov. 23, 1992).
\5 Pesticides: EPA Lacks Assurance That All Adverse Effects Data
Have Been Reviewed (GAO/T-RCED-92-16, Oct.30, 1991).
\6 Food Safety and Quality: FDA Needs Stronger Controls Over the
Approval Process for New Animal Drugs (GAO/RCED-92-63, Jan. 17,
1992).
\7 Final Report of the Advisory Committee on the Food and Drug
Administration (Washington, D.C., May 1991).
PROBLEMS IN THE LEGAL AND
REGULATORY STRUCTURE COMPROMISE
AGENCIES' EFFORTS TO REDUCE RISK
============================================================ Chapter 3
Chemicals posing similar risks may be regulated differently under
different laws. Chemicals not allowed under one law or regulation
may be allowed under another and may therefore enter the food supply.
Moreover, unapproved chemicals may be in food because agencies'
regulatory policies that allow the emergency use of such compounds
are misused, and chemicals intended for infrequent use become
commonplace. Finally, many highly toxic chemicals, present in the
environment from industrial pollution (environmental contaminants),
are not specifically required to be regulated by federal food safety
laws.
DIFFERENT LEGAL STANDARDS
RESULT IN DIFFERENCES IN
ALLOWABLE CHEMICALS
---------------------------------------------------------- Chapter 3:1
Differences in federal food safety laws have resulted in different
standards for chemicals posing similar risks. Consequently,
consumers may be exposed to chemicals that at least one agency,
operating under one act, considers allowable, but which another
agency, operating under different legislation, may not consider
allowable. Also, federal agencies are generally not required to
periodically reevaluate chemicals approved in the past against
current scientific standards.
SOME LAWS ESTABLISH
DIFFERENT STANDARDS FOR
CHEMICALS POSING SIMILAR
RISKS
-------------------------------------------------------- Chapter 3:1.1
No matter how successfully agencies identify chemical risks through
the scientific risk assessment process, they may have to regulate
chemicals presenting similar risks differently. This happens because
(1) some provisions of the laws allow agencies to consider both risks
and benefits while others do not and (2) federal laws prescribe
different standards of acceptable risk for chemicals that otherwise
pose similar risks.
Agencies may differ in their determination of what is an allowable
chemical because some provisions of the federal laws may allow one
agency to consider both risks and benefits but not allow another
agency to do so. For example, under the Clean Water Act, EPA issues
water quality criteria that state agencies may use to determine if
the levels of contamination in water render the fish harvested from
it harmful to consumers' health. EPA is required only to consider
risks to human health and aquatic life when conducting water quality
assessments. However, under the FFDCA, FDA is responsible for
setting tolerance levels for chemical contamination in fish and
shellfish that move in interstate commerce. FFDCA allows FDA to
consider both health risks and benefits in establishing tolerances
for chemical contaminants in food. Therefore, FDA's standards for
some chemicals are often less stringent than those developed by EPA,
according to EPA officials.
These differences in EPA's and FDA's standards result in much
confusion for the state agencies that are ultimately responsible for
monitoring the safety of local fish and for issuing fish consumption
advisories. According to a 1990 EPA study, states do not use
consistent risk assessment methodologies or agree on the levels of
fish consumption considered safe in a given situation. For example,
while 34 states use FDA's methodology to determine the level of
concern in fish, 10 use EPA's, and 8 have developed their own
methods. Therefore, situations may arise in which one state may ban
consumption of fish from a certain body of water, while a neighboring
state, using a different federal approach, may allow consumption of
fish from the same body of water. For example, Minnesota--using
EPA's criteria--advises fishermen not to consume certain fish from a
20-mile stretch of the St. Croix River between Stillwater,
Minnesota, and Prescott, Wisconsin. But Wisconsin--using FDA-based
criteria--does not consider fish from the same body of water a health
risk and permits their consumption.
Concerned about the differences in EPA's and FDA's guidance, state
officials have requested that the federal government provide them
with consistent risk assessment guidelines. Nevertheless, EPA and
FDA continue to provide separate guidance documents based on their
differing legislation. For example, EPA is currently working on a
four-volume set of comprehensive guidance documents to help states
assess chemical contaminant data for use in determining the need for
fish advisories. The first volume on Fish Sampling and Analysis was
published in August 1993, the second volume on Risk Assessment and
Fish Consumption Limits was published in July 1994, and two other
volumes on Risk Management and Risk Communication are currently being
developed. In 1993, FDA also issued five contaminant-specific
documents to the states to help them determine the need for fish
advisories and has plans to issue another seven documents in the near
future. Both EPA and FDA officials justified pursuing these separate
efforts because of the need to fulfill the requirements of their
separate legal mandates.
Similarly, as we recently reported, section 409 of the FFDCA contains
a general food safety clause that requires agencies to determine
whether the use of an additive to food "will be safe." However, EPA
and FDA interpret this clause differently. EPA believes that this
clause allows it to consider both risks and benefits when setting
tolerances for noncarcinogenic pesticide residues. FDA, on the other
hand, believes that this clause allows only a risk-based standard and
therefore does not consider any benefits when approving and setting
tolerances for other food additives, including animal drugs.
Furthermore, some federal laws prescribe different standards for
chemicals that otherwise pose similar risks. As a result, EPA may
allow the use of a chemical on certain foods but disallow it on other
foods. EPA may approve a carcinogenic pesticide that presents a
negligible risk for use on food under FIFRA and establish a tolerance
for this pesticide's residue on raw agriculture products under
section 408 of the FFDCA. The FFDCA also allows this carcinogenic
residue to remain in processed food as long as it does not
concentrate to a level above the raw food tolerance and as long as
the pesticide is not added during or after processing. However,
section 409 of the FFDCA, which applies to all pesticides that
concentrate in processed foods or that are added to foods during or
after processing, includes a different provision--the Delaney
Clause--for carcinogenic compounds. Under the Delaney Clause, EPA
must use a zero-risk standard for carcinogenic pesticide residues
that concentrate in processed food or are added to food during or
after processing, no matter how negligible the risk. Therefore, EPA
may issue a tolerance for a carcinogenic pesticide on raw tomatoes if
the risk is negligible, and a tolerance for canned tomatoes if the
pesticide's residues do not concentrate above the raw tomato
tolerance. But it may not issue a tolerance for tomato paste if the
pesticide's residues concentrate above the raw food tolerance. As we
recently reported, this difference in standards has resulted in EPA's
approving tolerances under section 408 for pesticides that it found
to be potentially more carcinogenic to humans than other pesticides
for which it has not been able to issue a tolerance under section
409.\1
In 1987, the National Academy of Sciences recommended that consistent
standards be set for all pesticide residues in foods. To overcome
this difference, EPA established in 1988 a negligible risk standard
to regulate all pesticide residues, including those covered by the
Delaney Clause. Under this standard, EPA could approve a
carcinogenic pesticide and set a 409 tolerance if its use results in
negligible risk or a cancer risk of 1 in 1 million from a lifetime of
exposure. However, EPA's policy was overturned by the Ninth Circuit
Court of Appeals in July 1992 as incompatible with the Delaney
Clause. In response to the court's ruling, EPA has identified about
30 pesticides approved since 1988, under the negligible risk
standard, whose tolerances may have to be revised to bring them into
compliance with the Delaney provision of section 409. These
compounds are used in about 100 different raw and processed food
applications.
For almost a decade, we and others have concluded that the Congress
should reconsider the differences between the FFDCA's sections 408
and 409 and FIFRA. Over the last few years, a number of policy
options have emerged to resolve the differences in the federal
pesticide laws. The three policy options proposed are
allowing a zero risk of cancer with no consideration of benefits,
allowing a negligible risk with no consideration of benefits, and
allowing a negligible risk with limited consideration of benefits.
In April 1994, the administration proposed comprehensive pesticide
policy reform legislation that includes, among other things, amending
the FFDCA to require EPA to set tolerances for pesticide residues in
all types of food in accordance with a health-based safety standard.
This standard would require a reasonable certainty of no harm to
consumers and would establish a negligible risk for carcinogens.
--------------------
\1 Pesticides: Options to Achieve a Single Regulatory Standard
(GAO/RCED-94-57, May 13, 1994).
NOT ALL AGENCIES REQUIRED TO
REEVALUATE COMPOUNDS
APPROVED UNDER EARLIER
SCIENTIFIC STANDARDS
-------------------------------------------------------- Chapter 3:1.2
Although advances in scientific knowledge may raise questions about
the safety of compounds approved in the past, federal law does not
generally require the agencies to periodically and systematically
reevaluate these compounds. Only EPA is required by FIFRA to update
information on all pesticides approved under less stringent
government standards and to reregister those chemicals that meet
current standards. FDA has no such requirement for animal drugs and
reviews and/or withdraws approved drugs only if a problem comes to
its attention.
To meet its FIFRA requirement, EPA has developed a formal system to
reevaluate the pesticide products approved in the past against
current scientific standards. Although the Congress has mandated
that EPA complete the reregistration process for about 20,000
pesticide products generally by 1998, we reported in May 1993 that
this formidable and complex task may not be completed before the year
2006. EPA still needs to review a large number of studies to allow
pesticides to be fully reassessed.\2 In the interim, previously
registered pesticides may continue to be used on food under their
existing registrations and tolerances. Since EPA began the
reregistration process, hundreds of pesticides have been voluntarily
canceled by pesticide registrants because the fees and costs of
developing new data to meet EPA's current pesticide requirements
would outweigh the expected income from sales.
Recognizing the importance of reevaluating approved pesticides
against current scientific standards, in its April 1994 proposed
pesticide reform legislation, the administration recommends, among
other things, a "sunset provision." Under this provision, a
pesticide's registration would expire after 15 years, unless EPA
approved a registrant's new application. The new application would
have to meet the current scientific standards for safety. In our
October 1993 comments on these provisions, we said that such a
provision would help ensure that pesticides not meeting the most
current scientific standards would be taken off the market.\3
In contrast, FDA has not undertaken such a reevaluation of approved
animal drugs because it is not required to do so. FDA officials told
us that while they had considered the need to reassess older animal
drugs on a cyclical basis in the past, they did not have the
resources to implement such a program. Therefore, FDA reassesses
approved compounds only on a causal basis--as the need arises.
According to FDA officials, about six older animal drugs have
actually been reassessed and their approvals withdrawn because of
safety and efficacy concerns. FDA officials told us that while some
compounds on the market have not been reevaluated since first
approved, they generally believe that the market share of these drugs
is relatively small; consequently, reevaluating them is a low
priority for FDA. However, without definitive evidence that this is
the case, we question FDA's low priority classification for
reevaluating animal drugs approved in the past.
--------------------
\2 Pesticides: Pesticide Reregistration May Not Be Completed Until
2006 (GAO/RCED-93-94, May 21, 1993).
\3 Pesticides: Reregistration Delays Jeopardize Success of Proposed
Policy Reforms (GAO/T-RCED-94-48, Oct. 29, 1993).
REGULATORY POLICIES WEAKEN
CONTROLS OVER UNAPPROVED
COMPOUNDS
---------------------------------------------------------- Chapter 3:2
Both EPA and FDA allow users of pesticides and animal drugs access to
unapproved compounds to address emergency situations. However, we
have questioned EPA's repeated use of emergency pesticide exemptions
and have reported that extra-label drug use\4
has been misused. As a result, the use of unapproved chemicals has
become a routine practice. The long-term, widespread use of these
policies also places chemical manufacturers that seek approval of
their products at a competitive disadvantage.
--------------------
\4 Under the FFDCA, if an animal drug is used in a manner other than
that specified on its FDA-approved label, it is considered to be an
extra-label use and is in violation of the act.
REPEAT EMERGENCY PESTICIDE
EXEMPTIONS MAY PROVIDE
POTENTIAL FOR ABUSE
-------------------------------------------------------- Chapter 3:2.1
Since 1978, we have reported several times that EPA repeatedly grants
emergency exemptions for pesticides, and we have questioned whether
some of these situations were true emergencies. Section 18 of FIFRA
allows EPA to grant emergency exemptions for unregistered pesticides
if emergency conditions exist that warrant such an exemption. Under
the EPA regulations, before the agency grants an emergency exemption,
it must judge, among other things, whether an emergency situation
exists, whether the pesticide will result in adverse health and
environmental effects, and, for repeat exemptions, whether reasonable
progress has been made toward registration.
In 1991, we reported that EPA generally tends to approve over 70
percent of the emergency exemption applications it receives every
year. Since 1978, almost 4,500 emergency exemptions have been
granted for unregistered pesticides.\5 Moreover, as we reported, EPA
has repeatedly granted emergency exemptions for the same pesticide
uses for several years; in one case, these exemptions had been
granted for as many as 12 years.
Part of our concern with repeat emergency exemptions stems from the
lack of specific criteria for defining emergencies and of complete
applications for registration. In June 1992, EPA issued guidance for
state and federal agencies that explains EPA's requirements for an
emergency exemption application, the documentation required, and the
policies and criteria that the agency uses when evaluating an
emergency application request. According to EPA officials, this
guidance should clarify the agency's requirements in the future.
Nevertheless, in a 1987 and 1988 report prepared by EPA's
Registration Division summarizing emergency exemptions, EPA
recognized that a repeat exemption "represents or at least gives the
appearance of circumvention" of the registration process. Two
principal concerns result from these exemptions. First, a greater
public health concern exists about these pesticides because they have
not gone through EPA's registration process, which would subject them
to a review of human health and environmental effects. Therefore,
the extent of their safety is not known. Second, these exemptions
may be placing companies that register pesticides and incur the cost
associated with registration at a competitive disadvantage with those
companies that are able to sell their chemicals for uses that are not
registered.
--------------------
\5 Pesticides: EPA's Repeat Emergency Exemptions May Provide
Potential for Abuse (GAO/T-RCED-91-83, July 23, 1991).
USE OF UNAPPROVED ANIMAL
DRUGS IS WIDESPREAD
-------------------------------------------------------- Chapter 3:2.2
Extra-label drug use is widespread and raises questions similar to
those posed by emergency pesticide exemptions. By allowing
extra-label drug use, FDA enables the users to bypass important
safeguards for tolerances and withdrawal times. FDA established an
extra-label use policy for animal drugs with the intention that such
uses would be rare--for emergency situations only. The extra-label
use policy allows veterinarians to treat animals with unapproved
drugs when certain conditions are met; FDA does not take enforcement
action in these situations.
We reported in 1992 that, contrary to FDA's intent, extra-label drug
use was not an uncommon or rare practice but was actually widespread
in dairy cows.\6 Several veterinarians who treat dairy cows told us
that between 40 percent and 85 percent of their dairy cow
prescriptions are for extra-label uses. The National Academy of
Sciences reported similar concerns about the unapproved use of animal
drugs in aquaculture. Although disease is a limiting factor in the
culture of aquatic animals, only five animal drugs have been approved
for use in aquaculture. Because of the lack of approved drugs, the
aquaculture industry is using in cultured fish about 50 animal drugs
approved for terrestrial food-producing animals.\7 This practice may
pose a risk to human health if residues persist in the edible tissue
of the fish. FDA has modified its drug approval program to help
expedite the approval of animal drugs for aquaculture, but it may be
many years before some of these drugs have adequate data to support
their safety and efficacy and are reviewed and approved for use by
FDA.
Moreover, the extra-label drug use policy, like EPA's pesticide
emergency exemption policy, may discourage animal drug manufacturers
from seeking approval for additional uses of their drugs. If
manufacturers know that they can sell the drugs without incurring any
additional regulatory costs or enforcement action, they are not
likely to incur the additional costs of seeking approval.
--------------------
\6 Food Safety and Quality: FDA Strategy Needed to Address Animal
Drug Residues in Milk (GAO/RCED-92-209, Aug. 5, 1992).
\7 FDA has classified 13 of the 50 unapproved drugs used in
aquaculture as having low regulatory priority.
CURRENT LAWS DO NOT ENCOURAGE
AGENCIES TO MONITOR
ENVIRONMENTAL CONTAMINANTS
---------------------------------------------------------- Chapter 3:3
Although over 60,000 industrial chemicals, regulated under the Toxic
Substances Control Act, are currently in use in the United States, no
food safety law specifically requires agencies to develop plans to
monitor the presence of these chemicals in food. Instead, action is
taken and resources allocated to these chemicals only when an
incident that may threaten human health, or even life, occurs. Even
if such laws were in place, federal agencies would require a
substantial investment in staff and funds to establish a risk-based
system to identify and monitor how many of this large number of
chemicals are in the food supply.
Any food-monitoring activities that FDA and USDA conduct for
environmental contaminants are authorized by the general food safety
provisions of their principal legislation. The FFDCA, FMIA, and PPIA
all specify that if any poisonous or deleterious substance is added
to food, it will render the food unsafe and unfit for human
consumption. FDA is the primary agency responsible for setting
tolerances for environmental contaminants in food. However, because
the FFDCA does not specifically require FDA to set these tolerances,
the agency has done so only when it believes that such tolerances are
necessary. For example, for seafood, FDA has set one formal
tolerance--for polychlorinated biphenyls,\8 a banned carcinogenic
industrial compound--and 15 informal residue standards for other
chemical contaminants.\9
Although FDA ranks environmental contaminants, such as lead and
mercury, as being a significant food safety concern, at least as
important as pesticide residues, it has established few tolerances
for these chemicals. According to FDA officials, unlike pesticides
and animal drugs, no sponsor is required to submit the data necessary
to establish tolerances for environmental contaminants. Therefore,
FDA must gather all the data itself, which is both costly and
time-consuming, especially if the agency has to gather data for all
possible environmental contaminants.
The lack of tolerances for some environmental contaminants--such as
heavy metals--affects other federal and state agencies' efforts to
look for these contaminants in the food they monitor. We recently
reported that USDA was not testing either domestic or imported meat
products for environmental contaminants, specifically heavy metals,
because these compounds did not have U.S. tolerances.\10 Although
USDA was aware that foreign countries were experiencing a problem
with some of these contaminants and had found violative residue
levels in their own domestic testing programs, USDA did not request
FDA to consider establishing regulatory standards for such
contaminants until 1994.
Given the large number of potential environmental contaminants that
could enter the food supply, developing a risk-based approach will be
critical to effectively monitoring these compounds in the food
supply. However, developing a risk-based system to monitor these
contaminants will require additional resources so that federal
agencies can obtain the necessary data and expertise to assess the
risks from these compounds. Monitoring environmental contaminants in
food is made even more complex by the fact that many of these
chemicals are a concern only at the local or regional level. FDA
officials told us that developing national standards and monitoring
programs for such chemicals may be an ineffective use of resources.
Given the highly toxic nature of some environmental contaminants, we
believe that setting national standards for these compounds should be
a high priority for the federal government and that monitoring
programs could be improved through greater federal-state cooperation
in this area.
--------------------
\8 Polychlorinated biphenyls include more than 200 different
compounds that were used in a variety of industrial applications
before they were banned in the late 1970s.
\9 When adequate data are not available to justify the setting of
formal tolerances, FDA may choose to set an informal standard for a
chemical; informal standards, unlike tolerances, are not binding on
the agency or industry.
\10 Food Safety: USDA's Role Under the National Residue Program
Should Be Reevaluated (GAO/RCED-94-158, Sept. 26, 1994).
FUNDAMENTAL WEAKNESSES IN FEDERAL
ENFORCEMENT PROCESSES
============================================================ Chapter 4
Under existing approaches, the federal government cannot ensure
compliance with the standards it has put in place for chemicals in
food. Federal agencies' efforts to test the food supply for the
presence of unsafe levels of chemicals are resource-intensive,
inefficient, and ultimately ineffective. Moreover, even when
violations are detected, responsive enforcement action often does not
occur. An alternative monitoring approach now being employed by food
processing companies could provide a more efficient avenue for future
federal efforts to ensure compliance.
END-PRODUCT TESTING IS
INEFFECTIVE AND DOES NOT USE
LIMITED RESOURCES EFFICIENTLY
---------------------------------------------------------- Chapter 4:1
Federal efforts to test the food supply for compliance with chemical
standards rely on the approach of end-product testing--testing
products during the final stage of production. To be effective, this
approach requires agencies to expend considerable resources to (1)
obtain comprehensive information on chemicals in use for all products
and (2) develop test methods that detect all chemical compounds of
concern. The agencies generally lack the resources to implement this
approach in the comprehensive fashion that is necessary for it to be
effective at the retail level.
AGENCIES RELY ON END-PRODUCT
TESTING TO ENSURE COMPLIANCE
-------------------------------------------------------- Chapter 4:1.1
To ensure that the U.S. food supply complies with federal standards,
FDA and the Food Safety and Inspection Service have historically
sampled and tested food products for the presence of chemical
residues and environmental contaminants before they are marketed.
While the compounds/commodities tested each year may vary, the
agencies have generally relied on the results of sample analysis to
assure consumers that the food supply is safe from harmful chemical
contamination.
Both FDA and FSIS use a two-pronged approach to their chemical
residue and environmental contaminants monitoring programs. FDA
monitors chemicals in food through (1) surveillance monitoring--used
when there is no reason to suspect a problem, and (2) compliance
monitoring--used for commodities where a violation has been found in
the past or is suspected. In fiscal year 1992, FDA had 10
chemical-monitoring programs through which it sampled and analyzed
over 17,000 domestic and imported food products for pesticides,
animal drugs, and industrial chemicals. (See app. II for a list of
FDA's compliance programs and assignments for fiscal year 1992.) FSIS
monitors chemical residues and environmental contaminants in meat and
poultry through its National Residue Program (NRP). The NRP has both
(1) a monitoring program to collect and analyze routine random
samples and (2) a surveillance program to test samples when
contamination is suspected.\1 In 1992, FSIS conducted almost 375,000
chemical residue analyses on domestic and imported meat and poultry
samples for pesticide and animal drug residues.\2 (See app. II for a
list of compounds that FSIS' NRP tested for in 1992.)
--------------------
\1 In addition, the NRP has exploratory and individual enforcement
testing programs as part of the overall program.
\2 FDA and FSIS do not track samples and analyses in the same manner.
FDA tracks the total number of physical samples that it collects, not
the number of chemical tests that a sample is analyzed for. FSIS, on
the other hand, tracks the total number of analyses performed, not
the total number of physical samples.
LACK OF USAGE DATA LIMITS
THE COMPREHENSIVENESS OF
END-PRODUCT TESTING
-------------------------------------------------------- Chapter 4:1.2
Generally, federal agencies have been unable to target their
inspection resources to the chemical/food combinations most likely to
be hazardous because they lack reliable and comprehensive data on the
chemicals used in food production. As a result, their nontargeted
testing efforts may not adequately cover all the chemicals of
concern.
The agencies are limited in their ability to obtain reliable
chemical-use data because of insufficient resources, according to
agency officials. In 1992, we found that FDA did not have reliable
information on the total number of animal drugs, both approved and
unapproved, that were being used on dairy cows. Consequently, the
number of animal drug residues that may be present in milk was
unknown. To develop a list of such drugs (82 in all),\3 GAO turned
to multiple sources, such as state surveys and market research data,
as well as our own interviews and observations at the farm level.
According to the Director of the Office of Surveillance and
Compliance in FDA's Center for Veterinary Medicine, reliable and
comprehensive drug usage information would (1) improve FDA's efforts
to monitor drug residues in milk and (2) help the agency provide
critical information to FSIS for its national residue program for
meat and poultry. In 1992, Center for Veterinary Medicine officials
told us that the agency is hampered in its efforts to collect
information from veterinarians/users of animal drugs because this is
a resource-intensive activity. According to these officials, FDA's
limited resources, the large number of users of animal drugs, and the
extensive paperwork involved has precluded the agency from collecting
drug-use information. The agency has largely relied on the purchase
of commercially available data as their primary source of drug-use
information.
Usage data have also been lacking until recently for pesticides used
on domestic crops. Since fiscal year 1990, as part of USDA's Water
Quality and Food Safety Initiatives, the National Agricultural
Statistics Service has been collecting such data for on-farm
pesticide use on fruits, vegetables, and field crops. According to
both EPA and FDA officials, this program has provided them with much
needed information, and they would like to see the program's limited
scope expanded to include data for pesticides used on all
agricultural commodities. In addition, an EPA official told us that
the agency would like to receive information on the pests being
targeted and on post-harvest chemical applications. Officials from
both agencies were concerned that while this program provides
critical data for their efforts to monitor chemical residues, no
assurance exists that the program would continue to receive funding
from USDA.
To overcome the limitations in usage data and resources, federal
agencies have set risk-based priorities for monitoring chemical
compounds. Although such a risk-based approach is the most logical
method for ensuring safety, these programs are not effective because
of implementation problems. As a result, monitoring of even those
chemicals the agencies consider most harmful is often incomplete.
More specifically, FSIS has been unable to monitor the chemical
compounds in meat and poultry that pose the greatest risk to human
health because it is backlogged in its evaluation of these compounds.
FSIS includes in its monitoring program those chemicals that have a
high priority based on the agency's evaluation of the chemical's
risk. However, we recently reported that of the 367 potential
compounds of concern that FSIS identified, 240 had not yet been
evaluated and ranked. As a result, these chemicals were not included
in the program for testing, and it is not known how many of them are
entering the meat and poultry supply.\4 Moreover, although FSIS'
criteria require that when no violative results appear after 1 to 3
years of testing, the compound should be a candidate to be cycled out
of the program, we reported that many of these compounds continued to
be included in the program. As a result, FSIS' limited testing
resources were being diverted to monitoring low-risk compounds.
FDA also has been unable to fully monitor its list of priority
pesticides because of competing demands for its limited testing
resources. In its 1990 plan for pesticide residues, FDA targeted for
its monitoring programs 225 priority agricultural pesticides. These
pesticides were identified from a master list of about 700 potential
pesticides used in the United States and abroad. However, FDA has
been unable to test all the chemicals identified in its 1990 plan,
according to FDA's Strategic Manager for Pesticides and Chemical
Contaminants. Outside pressures and unanticipated incidents have
required the agency to redirect resources to commodities/chemical
combinations not included in the plan.
--------------------
\3 FDA has since expanded this list to 85 drugs.
\4 Food Safety: USDA's Role Under the National Residue Program
Should Be Reevaluated (GAO/RCED-94-158, Sept. 26, 1994).
LACK OF MULTI-RESIDUE TEST
METHODS FURTHER LIMITS
EFFECTIVENESS OF END-PRODUCT
TESTING
-------------------------------------------------------- Chapter 4:1.3
The effectiveness of the federal government's end-product testing is
further compromised by the lack of adequate analytical test methods
to identify and quantify all chemical compounds of concern. While
chemical registrants/sponsors must provide an analytical method for
their compound, these methods are usually single-residue
methods--methods that can detect only one compound-- which federal
agencies prefer not to use for routine monitoring purposes.
Generally, federal agencies prefer to use multi-residue methods that
detect multiple compounds in a single test and are therefore more
cost-effective than single-residue methods. Federal agencies must
develop their own multi-residue methods because chemical sponsors
cannot be required to do so. However, the agencies are constrained
in their multi-residue test development, not only by resources but
also by differing regulatory needs and changing technology.
Because test method development requires extensive expenditures and
time, agencies have been unable to develop all the multi-residue
tests that they need. For example, FDA has five primary
multi-residue tests for pesticides. If all five tests are conducted
on a food product, they can detect only about half of the
approximately 300 pesticides with approved tolerances. Similarly,
FSIS has adequate detection methods for only about 36 of the 48
compounds identified as being highly hazardous to consumers of meat
and poultry.\5
To overcome resource constraints, FDA has in recent years taken two
actions to shift to chemical registrants/sponsors the responsibility
for developing test methods that will meet its needs. First, FDA
requested, and EPA implemented, a requirement that pesticide
registrants indicate whether a new pesticide is recoverable by any of
FDA's existing multi-residue methods. Second, FDA has developed
guidelines to shift the responsibility for test method
validation--proof of the test method's effectiveness to collect
analytical data--for animal feeds to the industry. Currently, the
federal government must maintain a complete laboratory infrastructure
to support method validation trials. If this program is successful,
FDA hopes to expand it to animal drugs.
Federal agencies could use resources more efficiently if they better
coordinated their efforts to develop test methods. Agency officials
told us that they need to develop test methods separately because
their regulatory needs for precision in test results differ.
However, we and others believe that a more coordinated federal test
method development program might use resources more efficiently and
foster the development of additional test methods. In 1988, the
Office of Technology Assessment concluded that the amount of
resources available for methods research for pesticide residues
increases the need for coordination between agencies. Similarly, in
its 1993 report, the Federal Coordinating Council for Science,
Engineering, and Technology concluded that to effectively meet future
research challenges, including methods development, federal
regulatory agencies would need the collective and coordinated policy
and resources of the federal government.
Interagency coordination and the efficient use of resources become
even more critical because advances in technology can also impede the
development of test methods. For example, changes in the chemical
structure of pesticides have impeded FDA's efforts to develop new
multi-residue tests. Newer pesticides are made from more chemically
diverse compounds than older pesticides, and they also degrade more
quickly. These characteristics significantly increase the scientific
task of developing adequate multi-residue methods, according to a
1987 study by the Congressional Research Service. To try to keep
pace with the changing technology, agencies such as FDA are
developing selective multi-residue methods, which detect only a few
compounds versus the 50 to 100 compounds detectable by traditional
multi-residue methods.
--------------------
\5 Food Safety: USDA's Role Under the National Residue Program
Should Be Reevaluated (GAO/RCED-94-158, Sept. 26, 1994).
END-PRODUCT TESTING IS NOT
STATISTICALLY REPRESENTATIVE
---------------------------------------------------------- Chapter 4:2
The results of end-product testing can be extrapolated to the total
food supply only if statistically representative sampling is
conducted. However, federal agencies either do not conduct such
sampling or have poorly implemented statistically representative
methodologies, thereby compromising their results.
For end-product testing to accurately depict the level of chemical
residues and environmental contaminants in the food supply, federal
agencies would have to conduct statistically representative sampling
and testing. The results of a statistically representative sample
could be projected to determine the level of a given chemical in the
entire food supply. However, statistically representative sampling
does not generally occur. Most of FDA's testing is conducted under
its surveillance program, which does not have a statistically based
sampling process. FDA cites a lack of resources and competing
priorities as factors inhibiting its ability to conduct statistically
representative testing of the food supply. For example, for
pesticide residues alone, a statistically representative monitoring
program for all commodities would cost over $45 million annually,
according to FDA's estimates. Currently FDA allocates between $20
and $30 million annually to monitoring both pesticides and industrial
chemicals in food.
Even FSIS, which has a statistically representative residue
monitoring program for meat and poultry, has implementation problems
that compromise the validity of its test results. We and USDA's
Office of Inspector General have found examples of FSIS inspectors'
improperly implementing the sampling plan. Most recently,\6 we found
that (1) random selection procedures were not followed consistently
by FSIS inspectors when selecting samples for testing, (2)
climatic/geographic and seasonal adjustments were not made for all
affected species, and (3) different animal species were not sampled
at the same rate for the same compound, nor were the same species
sampled at the same rate for different compounds.
Despite these problems with their sampling plans, federal agencies
tend to make broader conclusions about the level of chemical residues
in the food supply than their test results warrant. For example, in
1990 we reported that FDA could not support its conclusion that the
milk supply was free of harmful drug residues.\7 We found that the
three surveys on which FDA had based its conclusion were only
"snapshots" in time and that the limitations in methodology should
have precluded FDA from reaching its conclusion.
Similarly, FSIS has made statements about the trends of residues in
meat and poultry that we and others have questioned. As we recently
reported, to reach its conclusion FSIS combines and averages the test
results for the different residues tested. However, this approach is
not a valid one because it assumes that a sample contaminated with
one kind of residue will not contain any other kind of chemical
contamination. In the past, we estimated that the true violation
rate for meat and poultry is probably closer to the sum of the
violation rates for all residues tested.
--------------------
\6 Food Safety: USDA's Role Under the National Residue Program
Should Be Reevaluated (GAO/RCED-94-158, Sept. 26, 1994).
\7 Food Safety and Quality: FDA Surveys Not Adequate to Demonstrate
Safety of Milk Supply (GAO/RCED-91-26, Nov. 1, 1990).
NEWER MONITORING APPROACHES
THAT COULD OVERCOME THE
INEFFICIENCIES OF END-PRODUCT
TESTING HAVE NOT BEEN
IMPLEMENTED
---------------------------------------------------------- Chapter 4:3
End-product testing, by itself, is not an efficient approach to
ensuring food safety. It does not prevent problems from occurring.
It only detects them after they have developed and after they may
have entered the food supply. Newer approaches, generally based on
the Hazard Analysis and Critical Control Points (HACCP) approach,
could overcome the weaknesses inherent in end-product testing. Some
food organizations have voluntarily adopted HACCP-based approaches to
ensuring food safety. However, the federal government has made
little progress in encouraging or requiring the use of such programs.
SOME FOOD COMPANIES ARE
USING HACCP
-------------------------------------------------------- Chapter 4:3.1
Some food companies and industries are voluntarily using monitoring
plans--often based on the HACCP approach--that serve as an
alternative to the traditional system of end-product inspection.
HACCP is a systems approach to contaminant control and management and
is as applicable to chemical residues as it is to microbial
contamination--the contaminant that HACCP was originally developed to
control. By emphasizing a complete-systems approach and ensuring
quality and safety from the very start of the food process, the HACCP
concept overcomes many of the weaknesses that are inherent in a
safety system that depends on end-product testing. The HACCP
approach has three fundamental components:
identifying the hazards and assessing the risk associated with each
stage of food production, including growing, harvesting,
processing, marketing, preparation, and use;
determining the critical points where the identified hazards can be
controlled; and
establishing procedures to monitor these critical control points.
We found numerous examples of food industry establishments and
organizations using or promoting the use of residue control programs
that move away from end-product testing as the primary quality
control mechanism. These programs focus on (1) controlling the
proper use of chemicals through good manufacturing practices so that
raw materials used by processors contain acceptable levels of
residues and (2) ensuring that the final product is in compliance
with federal food safety standards. These plans also contain a
critical element of the HACCP approach--moving to the industry the
responsibility for pre-market testing of food products for compounds
of concern.
For example, the National Turkey Federation has developed a program
to avoid pesticide and drug residues and environmental contaminants
in turkey production so that "the tissue of turkeys produced and
slaughtered in the United States will not contain any chemical
residues which may adversely affect the health of the consuming
public." The plan calls for good manufacturing procedures, including
specific requirements for feed, farm site, water, medication, and
vaccines. It also emphasizes the proper and controlled use of
chemicals as well as accurate recordkeeping and flock identification
systems to help trace the source of violations when violative
residues are found. Turkey producers are also required to test their
products for violative residues of polychlorinated biphenyls,
pesticides, chlorinated hydrocarbons, and drugs.
Similarly, the Campbell Soup Company has taken a total systems
approach to pesticide control that is premised on "Know thy supplier"
as the key to effective pesticide management. This plan controls the
presence of illegal pesticide residues in the company's products by
(1) controlling pesticide application and requiring suppliers to use
approved pesticides at the appropriate concentrations and application
rates, (2) emphasizing the use of integrated pest management
strategies to reduce overall pesticide use on crops, (3) requiring
companies to sample and test products for pesticides before
processing to ensure that they are free of any unacceptable residues,
and (4) emphasizing the need for proper lot identification and
recordkeeping in case a problem is discovered.
FEDERAL GOVERNMENT MAKING
SLOW PROGRESS IN
IMPLEMENTING THE HACCP
APPROACH
-------------------------------------------------------- Chapter 4:3.2
Although the federal government realizes the relevance of the HACCP
approach to controlling residues in foods, little progress has been
made toward implementing such programs. The only federal HACCP
programs currently in place are an FDA-mandated plan to control
microbial contamination in low-acid canned foods and a voluntary
fee-for-service plan for NMFS-inspected seafood establishments. FDA
developed and implemented the low-acid canned food regulations in
1974, after an outbreak of botulism from canned mushrooms. NMFS
announced the availability of its voluntary fee-for-service
inspection program, based on HACCP principles, in July 1992. This
program includes measures to identify and control chemical hazards in
seafood. USDA and FDA are developing other HACCP-based programs.
USDA is developing a plan to implement a mandatory HACCP-based system
for meat and poultry inspection that will address microbial,
physical, and chemical hazards.\8 However, even though the Secretary
of Agriculture announced in May 1993 that USDA would announce its
HACCP plans within 90 days, these plans were still unavailable as of
August 1994. FDA has also drafted a HACCP-based mandatory seafood
inspection plan. This plan was published for public comment in
January 1994.
Federal officials we spoke to agree that a HACCP-based approach is a
logical and cost-effective method of controlling contamination in
food and that it is a movement away from the federal government's
traditional approach for monitoring food safety. Under federal
plans, the federal government would oversee industry-based HACCP
programs. The food industry would be required to have in place
adequate programs to monitor the safety of its products as well as
conduct and document day-to-day monitoring activities. The
Commissioner, FDA, stated in January 1994, when announcing the
proposed mandatory HACCP plan for seafood:
"It's time to overhaul the system. . . .the best way to
provide safe food is to build safety into food products during
the production process. Under the current federal system, food
products are simply examined for safety after the fact."
Similar concerns were echoed by the Secretary of Agriculture, when
announcing USDA's plans to institute a mandatory HACCP program for
the meat industry. The Secretary stated that it "was necessary to
modernize and revolutionize an archaic system that must do a better
job of protecting consumers. We cannot continue to run a system
based on 1933 standards and procedures in 1993."
A shift to a HACCP-based approach may not be easily accomplished,
according to FDA officials and others. The officials we spoke to
said that the effective implementation of a HACCP plan would require
legislative changes to grant them authorities that they currently do
not have, such as access to industry records. Some public interest
groups have also raised concerns that without additional authorities
and funding, the government's effort to implement HACCP will be
ineffective in improving the safety of the U.S. food supply.
--------------------
\8 Physical hazards include hair, bone, and other such contaminants
that may occur in meat and poultry.
ENFORCEMENT MECHANISMS DO NOT
PREVENT DISTRIBUTION OF
CONTAMINATED FOOD OR DETER
FUTURE VIOLATIONS
---------------------------------------------------------- Chapter 4:4
Compliance with federal standards for chemical residues in food is
also not ensured because of problems in the enforcement mechanisms
available to federal food agencies. The enforcement system generally
requires monitoring agencies to report violations to FDA, the
enforcing agency, for follow-up action (interagency referrals).
However, responsive enforcement action often does not occur.
Moreover, because FDA lacks the authority to detain products or
assess civil penalties, it cannot effectively prevent the
distribution of violative products to consumers or prevent future
violations from occurring.
RELIANCE ON INTERAGENCY
REFERRALS IS INEFFECTIVE
-------------------------------------------------------- Chapter 4:4.1
Enforcement agencies do not always act on violations referred by
other agencies. For example, FSIS reports over 4,000 illegal drug
residue violations every year to FDA. However, according to a 1992
report by FDA's Extra-Label Use Task Force, because of limited
resources, FDA is unable to conduct follow-up investigations on the
majority of these referrals. In 1992, FDA and state agencies
together were able to investigate only about 1,100 (or 25 percent) of
USDA's referrals for illegal drug residues in meat and poultry. This
lack of follow-up on referrals clearly reduces the effectiveness of
federal efforts to enforce compliance with chemical residue
standards.
Federal agencies could investigate more violations if they made
better use of state resources in overseeing the safety of many food
products. In 1991, we reported that FDA could improve its oversight
over bottled water by using state inspection testing results, which
would eliminate the duplication of inspection efforts and free up
limited FDA resources for other activities.\9
Similarly, in 1992 we reported that FDA lacks a comprehensive
strategy to monitor drugs in milk that optimizes the state's and
industry's monitoring efforts.\10 Finally, according to a National
Academy of Sciences study on seafood, inspection efforts by FDA and
various state and local public health agencies are designed to ensure
safety but are insufficient to ensure in all cases that the
regulatory guidelines defined by FDA and EPA are not being
exceeded.\11 The report also stated that "recognizing the advantages
of regional/local control and surveillance is essential" to ensure
seafood safety.
--------------------
\9 Food Safety and Quality: Stronger FDA Standards and Oversight
Needed for Bottled Water (GAO/RCED-91-67, Mar. 12, 1991).
\10 Food Safety and Quality: FDA Strategy Needed to Address Animal
Drug Residues in Milk (GAO/RCED-92-209, Aug. 5, 1992).
\11 Seafood Safety (Food and Nutrition Board, Institute of Medicine,
National Academy of Sciences, 1991).
ABILITY TO PREVENT THE
DISTRIBUTION OF VIOLATIVE
PRODUCTS IS INCONSISTENT
-------------------------------------------------------- Chapter 4:4.2
The ability of FDA and USDA to prevent the distribution of
contaminated products to consumers is inconsistent. As we reported
in 1992, the FFDCA does not give FDA the authority to prohibit the
marketing of domestic products without a court order.\12 As a result,
while FDA is obtaining a court order for seizure, potentially unsafe
foods can be shipped and sold to consumers. In contrast, FSIS and
AMS have the authority to temporarily hold suspect food for up to 20
days without a court order.
In the past, we and others have reported on the need to provide FDA
with detention authority. In our 1984 report on FDA's enforcement
authorities and again in 1986, we asked the Congress to consider
providing FDA with the authority to detain products suspected of
being adulterated.\13 Similarly, a 1991 report from the Department of
Health and Human Services' Office of Inspector General concluded that
FDA's lack of immediate detention authority can allow adulterated
foods to enter the marketplace.
--------------------
\12 Food Safety and Quality: Uniform, Risk-Based Inspection System
Needed to Ensure Safe Food Supply (GAO/RCED-92-152, June 26, 1992).
\13 Legislative Changes and Administrative Improvements Should Be
Considered for FDA to Better Protect the Public From Adulterated Food
Products (GAO/HRD-84-61, Sept. 26, 1984); Need to Enhance FDA's
Ability to Protect the Public from Illegal Residues (GAO/RCED-87-7,
Oct. 27, 1986).
ENFORCEMENT AUTHORITY
AGAINST VIOLATORS IS OFTEN
INSUFFICIENT
-------------------------------------------------------- Chapter 4:4.3
Federal agencies also lack adequate authority to take enforcement
action against violators. This happens because FDA, which has
primary enforcement responsibility for most residue violations in
food, lacks the authority to assess civil penalties. As a result,
FDA must rely on the Department of Justice to follow through with
criminal charges. However, criminal charges are rarely assessed
because they take considerable time and significant resources to
pursue. Without the authority to assess civil penalties, FDA is
unable to deter future violations from occurring because producers
know that penalties will rarely be assessed, even in those instances
when violations are detected.
The number of cases pursued under the criminal law is minuscule. In
fiscal years 1989 through 1992, FDA investigated only about 4,500
cases of the over 21,000 violative residues in meat and poultry
referred to it. Of those cases investigated, 383 resulted in FDA
warning letters and 15 cases resulted in criminal proceedings--either
an injunction, citation, or prosecution. The Edwards Committee
stated in its 1990 report on FDA that the number of formal court
enforcement actions pursued by FDA had declined sharply since the
1970s. In the past, we and others have asked the Congress to
consider providing FDA with additional enforcement authorities,
including civil penalty authority, to effectively deter the marketing
of food with illegal residues and overcome the difficulties
associated with pursuing criminal penalties. The April 1994
pesticide reform bill introduced by the administration proposes
granting FDA additional enforcement authorities for pesticide
violations, including the authority to assess civil penalties.
In contrast, EPA, the federal agency responsible for following up on
pesticide-use violations, has under FIFRA a broader array of
enforcement authorities than FDA, including the assessment of civil
penalties up to $5,000 for each violation of the act. According to
EPA's Enforcement Response Policy, "A civil penalty is the preferred
enforcement remedy for most violations." The majority of pesticide
violation follow-up actions are conducted by state agencies under
EPA's federal-state cooperative agreement program. However, for
about 70 percent of those cases for which it was responsible in
fiscal year 1992, EPA assessed civil penalties.
FEWER CONTROLS EXIST FOR IMPORTED
FOODS
============================================================ Chapter 5
U.S. agencies have no jurisdiction over food producers in exporting
countries. As a result, to ensure compliance with U.S. food safety
standards, federal agencies must rely on the adequacy of exporting
countries' food safety systems and/or U.S. inspection and testing of
imported products at the port of entry. However, federal agencies
have limited assurance that exporting nations adequately inspect food
shipped to the United States, and FDA's inspection resources cannot
keep pace with the growing volume of imported food. Moreover,
federal agencies may not test some imported products for compounds
that are used in exporting countries but are not approved for use in
the United States. This occurs because (1) the agencies may have
incomplete data on these chemicals and/or (2) some U.S. inspection
programs focus only on domestic compounds of concern. Finally, as a
result of weaknesses in its regulatory authorities, FDA has been
unable to prevent the distribution of contaminated products to U.S.
consumers.
EXPORTING COUNTRIES' INSPECTION
SYSTEMS MAY NOT BE ADEQUATE
---------------------------------------------------------- Chapter 5:1
Although the United States relies only in part on the adequacy of
exporting nations' inspection systems to ensure the safety of food
imports, even such limited reliance is not always appropriate. We
reported in 1990 that exporting nations' monitoring of chemicals,
such as pesticides, is limited and may not provide assurances that
food exported to the United States is safe. For example, although
many exporting countries consider EPA's pesticide registration and
cancellation actions when making their own decisions, some chemicals
that have been canceled in both countries continue to be sold and
used in exporting countries even 15 years later.
Moreover, some exporting governments are not testing for chemicals
that are used in their countries but that are not registered for use
in the United States. For example, in 1990 we found that four out of
the five Latin American countries that we reviewed had limited
government monitoring and enforcement activities for pesticide
residues.\1 These countries lacked the resources not only to monitor
pesticide distribution and perform field sampling and testing, but
also to obtain information on U.S. requirements.\2 We found similar
problems in 1992 when we reviewed Mexican pesticide testing standards
and enforcement practices.\3 We reported that the Mexican government
had limited capabilities for monitoring the safety of exported
produce and did not have a program to monitor produce grown for
domestic consumption. The Mexican government generally expects the
private sector to monitor exported produce for pesticide residues.
Deficiencies have also been documented for exporting countries' meat
inspection systems. In 1989, USDA's Office of Inspector General
(OIG) reported deficiencies in some exporting countries' (1) ability
to detect certain key hazardous drug residues, (2) product sampling
plans, and (3) quality assurance programs to ensure the accuracy of
test results. Moreover, the OIG reported that two of the five
countries it reviewed lacked adequate control and accountability over
U.S. export certificates, which could result in the exportation of
meat that did not meet U.S. standards. According to USDA, all of
these problems have been rectified. However, the OIG is conducting a
follow-up review to determine if corrective actions have indeed been
taken by the countries involved.
--------------------
\1 The United States imports about 2.5 million metric tons of fruits
and vegetables annually from these five countries.
\2 Five Latin American Countries' Controls Over the Registration and
Use of Pesticides (GAO/T-RCED-90-57, Mar. 28, 1990).
\3 Pesticides: Comparison of U.S. and Mexican Pesticide Standards
and Enforcement (GAO/RCED-92-140, June 17, 1992).
FDA'S INSPECTION RESOURCES HAVE
NOT EXPANDED WITH GROWING
IMPORTS
---------------------------------------------------------- Chapter 5:2
FDA's inspections have not kept pace with the growing volume of
imported foods. For example, we reported in 1992 that FDA-regulated
shipments of imported food increased by 140 percent, from 500,000 in
1973 to 1.2 million in 1990, and now account for almost 10 percent of
the total U.S. food supply. In contrast to the 140-percent increase
in import volume, FDA staff devoted to monitoring shipments increased
by only 2 percent, from 355 in 1973 to 363 in 1990.\4 Because of this
disparity between available FDA resources and the increasing volume
of food imports, we and others have been concerned for many years
that FDA's limited inspection and testing cannot ensure that
contaminated imports are not entering the United States.
Historically, FDA has been able to test only a small percentage of
all imported shipments for chemical contamination--currently this
rate is about 1 percent. Inadequate resources is a primary reason
that the agency has not tested a larger percentage of imported foods,
according to FDA officials.
--------------------
\4 Pesticides: Adulterated Imported Foods Are Reaching U.S. Grocery
Shelves (GAO/RCED-92-205, Sept. 24, 1992).
LIMITATIONS IN U.S. TESTING OF
IMPORTED PRODUCTS
---------------------------------------------------------- Chapter 5:3
Imported products are not tested for all the compounds of concern
that may leave residues in these products. FDA and USDA are often
unable to obtain the data they need to direct their testing to those
compounds that are used in exporting countries. In addition, federal
agencies sometimes limit their import testing to compounds that are
of domestic concern only in the United States.
AGENCIES CANNOT OBTAIN
EXPORTING COUNTRIES'
CHEMICAL-USE INFORMATION
-------------------------------------------------------- Chapter 5:3.1
U.S. agencies cannot direct their limited testing resources to the
commodity/chemical combinations of greatest concern. This happens
because exporting nations may use chemicals that the United States
has not registered for use on food or for which it has not
established a tolerance. For example, we reported in 1993 that 58
food-use pesticides had Mexican tolerances for some commodities but
no comparable U.S. tolerances and that 17 pesticides had food-use
tolerances in Mexico but not in the United States.\5 To obtain
exporting countries' pesticide usage data, FDA relies on a variety of
information sources, including trade and professional journals,
commercial market data, informal contacts with exporting governments,
and the results of its own residue testing. In its comments on a
draft of this report, FDA stated that for the past several years it
has purchased worldwide pesticide usage data and conducted other
intelligence-gathering activities. As a result, FDA is directing its
testing to those commodities/chemicals of greatest concern. However,
according to a September 1993 report from the Keystone Center,\6 this
information has not been of much value to FDA in targeting its
pesticide testing. The Keystone Center report recommended that FDA
pursue additional avenues to collect better information on exporting
countries' pesticide use, to help improve the targeting of FDA's
enforcement efforts for imported foods.
To overcome the lack of data on pesticide use in foreign countries,
the Congress required FDA to collect pesticide usage data through
cooperative agreements with exporting countries under the Pesticide
Monitoring Improvements Act. Despite FDA's efforts, the agency has
been unable to obtain these data. FDA contacted 37 high-volume
exporting countries to obtain their pesticide-use data; however, only
9 complete responses were returned to FDA. According to FDA's
Strategic Manager for Pesticides and Chemical Contaminants, the
agency was unable to use much of the information provided because it
either was not what FDA had asked for, was of questionable accuracy,
or was in a foreign language. This official told us that the
response also reflected the exporting countries' lack of reliable and
sophisticated systems to collect this information and/or a perception
that such data collection activities were an attempt by the United
States to erect nontariff trade barriers. FDA has had more success
in obtaining pesticide usage data as well as ensuring compliance with
U.S. standards when it has worked directly with exporting
governments in a bilateral manner, which is less formal than the
PMIA's memorandum-of-understanding requirements.
USDA has similar problems in obtaining information on the chemicals
used in exporting countries that could result in residues in meat.
For example, we and USDA's OIG have raised concerns about USDA's lack
of information on drugs that have been approved for use in exporting
countries but that may have been banned or are not approved for use
in the United States. In 1989, USDA's OIG reported that four out of
five countries that it reviewed had approved animal drugs not
approved for use in the United States. Similarly, in 1992, although
our review was not comprehensive, we found at least seven drugs that
were approved for food-producing animals in Canada but not the United
States. These drugs represent varying degrees of potential risk to
human health and safety.\7
--------------------
\5 Pesticides: U.S. and Mexican Fruit and Vegetable Pesticide
Programs Differ (GAO/T-RCED-93-9, Feb. 18, 1993).
\6 The Keystone Center, a nonprofit organization, published a report
in September 1993 that summarizes the discussions that took place
during a meeting it held on food safety and pesticides.
\7 Food Safety and Quality: USDA Improves Inspection Program for
Canadian Meat, but Some Concerns Remain (GAO/RCED-92-250, Aug. 26,
1992).
EXPORTING COUNTRIES'
CHEMICAL USE MAY NOT BE
REFLECTED IN U.S. IMPORT
TESTING
-------------------------------------------------------- Chapter 5:3.2
U.S. agencies may not test some imported products for those
chemicals that are used in exporting countries but not in the United
States. Instead, some U.S. import testing programs test imports
only for chemicals used in the United States. For example, although
meat and poultry can be imported into the United States only from
countries that meet U.S. standards, these countries may be using
pesticides or animal drugs not approved or banned in the United
States. Because USDA's equivalency determination does not include a
review of chemicals approved and used in the exporting country but
not in the United States, a country may be eligible to export
products to the United States that contain residues of unapproved or
banned compounds. However, under the FFDCA, FMIA, and PPIA, any
residue of a compound not approved or banned in the United States is
considered an adulteration and cannot enter the food supply. As a
result, meat and poultry containing such residues are considered
adulterated and if detected must be condemned. However, we reported
this year that USDA's import inspection program tests only for
chemicals monitored under the U.S. domestic meat inspection program
and does not test for compounds used in exporting countries.\8 Even
when USDA was aware of potential chemical contamination problems in
exporting countries, it did not modify its import testing program to
reflect these concerns.
According to FSIS officials, testing imported meat and poultry for
compound residues other than those tested for domestically would
cause international trade problems. If USDA rejected imports, then
exporting countries might also reject U.S. products that contain
compounds approved in the United States but not in other countries.
While we agree that foreign trade concerns may be legitimate, several
facts remain: (1) U.S. food safety laws do not allow such
unapproved or banned chemical residues in meat and poultry and (2)
other countries have disallowed U.S. meat exports because U.S.
producers use chemicals not approved in these countries.
Similarly, in its 1991 study of seafood safety, the National Academy
of Sciences reported that many countries were using animal drugs in
aquaculture that were not approved in the United States. The report
stated that chloramphenicol, an animal drug banned in the United
States because it has been found to cause cancer, was being used in
foreign shrimp production. However, FDA was not testing foreign or
domestic aquaculture products for drug residues at that time and had
no information on the levels of these residues entering the food
supply. This practice could have widespread consequences because
imported cultured seafood accounts for a growing percentage of the
total seafood consumed in the United States. For example, over 140
million pounds of cultured shrimp are imported from China and
Ecuador, which do not regulate the use of chemotherapeutic agents in
cultured seafood. Similarly, more than 40 million pounds of cultured
salmon are imported annually from countries that lack tolerance
levels for residues. FDA did not begin testing imported and domestic
cultured shrimp for chloramphenicol until fiscal years 1992 and 1993,
respectively. According to FDA, the agency is restricted in its
testing of animal drugs in aquaculture because of inadequate
detection methods. FDA is developing additional test methods for
drug residues in aquaculture that will allow the agency to expand its
drug testing in this area.
--------------------
\8 Food Safety: USDA's Role Under the National Residue Program
Should Be Reevaluated (GAO/RCED-94-158, Sept. 26, 1994).
INADEQUATE AUTHORITY IMPEDES
FDA'S ENFORCEMENT EFFORTS
AGAINST VIOLATIVE FOOD IMPORTS
---------------------------------------------------------- Chapter 5:4
Contaminated imported foods that are regulated by FDA may be more
likely to enter the food supply than are those foods regulated by
USDA. The difference occurs because FDA's authorities are not as
strong as USDA's in the areas of enforcement and deterrents.
The FFDCA does not provide FDA with enforcement authorities that are
as powerful as those authorities directing USDA's enforcement
efforts. For example, FDA must rely on voluntary agreements with
exporting countries to comply with U.S. food standards, while USDA
has the authority to review and certify that an exporting country's
meat inspection system is equivalent to the U.S. system, before that
country can ship products to the United States.
In addition, importers retain possession of an imported shipment if
FDA decides to conduct residue testing of the shipment.
Consequently, adulterated products, especially perishable products
like fruits and vegetables, may be shipped to their destination and
may be consumed before the results of the tests are known. In 1992,
we reported that 60 percent of perishable foods and 38 percent of
nonperishable foods that FDA found adulterated with illegal
pesticides were released into U.S. markets and not returned to the
Customs Service for destruction or reexport, as required by FDA's
regulations. On the other hand, USDA must inspect and approve every
imported shipment of meat and poultry before it is released for
distribution. Therefore, each shipment is held by the Customs
Service until it is transferred to a USDA-approved facility for
inspection.
Finally, FDA has no control over rejected shipments and must depend
on the Customs Service to ensure that rejected shipments were
properly reexported or destroyed. But when USDA finds an
unacceptable imported meat shipment, it immediately places that
shipment in a controlled area, and rejected goods are released only
to a bonded carrier for reexport or destruction.
FDA lacks the authority to fine importers who distribute adulterated
food shipments. As a result, FDA cannot effectively deter illegal
distribution or prevent future occurrences. FDA must rely on a bond
agreement between the Customs Service and the importer as its
principal deterrent. The bond agreement requires the importer to pay
all duties, taxes, and charges; to retain control over the shipment;
and to properly dispose of the shipment if it is found to be
unacceptable. The bond amount is based on the value of the imported
shipment and may be assessed at up to three times the value of the
shipment. However, even a tripled bond value is often far less than
the price of the goods in U.S. markets. Moreover, when the importer
does not comply with the bond agreement, the collection of damages by
the Customs Service is often uneven and uncertain. In 1992, we
reported that the Customs Service assessed damages for only 27
percent of improper distribution cases in the four districts that we
reviewed. No damages were assessed for 73 percent of the cases
because (1) the importer had no bond, (2) the Customs Service had
already released the bond, and (3) FDA had made errors, such as not
communicating test results promptly.
Because FDA lacks civil penalty authority and must rely on the
importer's bond agreement with the Customs Service, it has been
unable to provide an adequate economic disincentive to the
distribution of adulterated imports for a long time. Moreover,
illegal distribution of adulterated imports is concentrated in a
small number of repeat offenders.\9 We reported in 1992 that in
fiscal years 1988 through 1990, importers at four locations had
distributed 336 (34 percent) of the 989 shipments found adulterated
with pesticides. Although this rate was lower than the rates of 50
percent and 45 percent that we found in 1979 and 1988, respectively,
it indicated that adulterated imports continue to be distributed to
American consumers.
In its comments on a draft of this report, FDA disagreed with our
statements that the agency lacks adequate deterrent authority for
imported products. FDA stated that it tests for far more chemicals
than USDA does and has the authority to detain products offered for
import, deny entry, or require reconditioning prior to entry. While
we agree that FDA tests more products than USDA, this testing is
FDA's primary assurance that imported products are safe. USDA's
testing of imported meat and poultry at the port of entry is only a
secondary level of assurance because USDA has mechanisms in place to
ensure product quality in the country of origin. Moreover, while
FDA's detention authority is a powerful tool, it alone is not
adequate. FDA must still rely on the Customs Service to ensure that
enforcement actions have been taken against violators. As we have
reported in the past, this often does not happen.
--------------------
\9 Pesticides: Adulterated Imported Foods Are Reaching U.S. Grocery
Shelves (GAO/RCED-92-205, Sept. 24, 1992).
CONCLUSIONS AND RECOMMENDATIONS
============================================================ Chapter 6
CONCLUSIONS
---------------------------------------------------------- Chapter 6:1
Ensuring the safety of the food supply becomes a greater challenge
each year as the number of chemicals in use continues to expand and
as additional environmental contaminants become concerns. While
federal agencies have improved their assessment and oversight of
risk, these efforts have not, or cannot, overcome five basic
structural weaknesses in the food safety system:
A fragmented federal effort to identify chemicals that pose a risk
to human health, which results in inconsistent assessments of
chemical risks.
A legal and regulatory infrastructure that permits the use of
unapproved chemicals in food.
A resource-intensive and inefficient compliance monitoring system
that by itself cannot detect all chemicals of concern.
An enforcement system that does not adequately deter or penalize
violators.
An import inspection system that cannot ensure that foods with
unapproved or banned compounds are not entering the United
States.
Although risk assessment is inherently difficult, the fragmented
agency structure for assessing risk exacerbates this problem.
Because FDA, EPA, and USDA have different food safety
responsibilities, their priorities for the data that should be
collected, their methods for analyzing these data, and their
conclusions about risk levels often do not coincide. Although each
agency's effort is hampered by a lack of sufficient resources, the
fragmented structure sometimes results in gaps and duplication that
the agencies can ill afford.
Even if completely reliable information were available, the basic
laws and regulations that govern chemicals in food do not support the
agencies' efforts to control chemical risks. This occurs because
these laws and regulations, established in response to emerging
concerns, do not always work in concert with each other. As a
result, a chemical not allowed under one act may be permitted under
another act because different agencies are allowed to apply different
risk standards. Equally important, federal laws do not require the
agencies to regularly reevaluate approved chemicals against current
scientific standards. Finally, while these laws do address the risks
posed by pesticide and animal drug residues in food, they do not
address the critical risk posed by environmental contaminants in
food.
The federal approach to monitoring chemicals in food--end-product
testing--is ineffective because it is essentially reactive. This
approach tries to catch problems after they have occurred because it
is resource-intensive. Reliance on this approach requires an
ever-increasing amount of resources both to test food for all of the
commodity/chemical combinations of concern and to develop all the
multi-residue tests needed to detect these residues. Newer
approaches to ensure food safety--such as HACCP--recognize these
difficulties and seek to build safeguards into food production.
Under such an approach, end-product testing becomes a secondary
rather than the primary method of ensuring that unsafe levels of
chemical residues and environmental contaminants do not remain in
food products. While the benefits of HACCP-based systems are
generally recognized, implementing such systems is a daunting task
that will require extensive support from the federal government, the
private sector, and consumers. In addition, federal enforcement
efforts do not provide the backup that is necessary to ensure
compliance with federal food safety standards when violations occur.
Finally, U.S. federal agencies have even less leverage in addressing
these problems in imported foods. Consequently, chemicals that are a
concern because they are used in exporting countries, but not in the
United States, may be entering the domestic food supply.
RECOMMENDATIONS TO THE CONGRESS
---------------------------------------------------------- Chapter 6:2
To overcome the fundamental weaknesses in the federal government's
programs for monitoring chemical residues and environmental
contaminants in food, the Congress should, at a minimum:
Enact a uniform set of food safety laws that include consistent
standards for chemical residues and contaminants in food and
provide the federal agencies with the authorities needed to
effectively carry out their oversight responsibilities.
Revise the nature of the federal government's role for ensuring
food safety by moving it away from end-product testing to
preventing contamination from occurring. Under such an
approach, the government would, among other things, (1) continue
to approve chemicals and set tolerances; (2) oversee a
mandatory, HACCP-based, industry-run food safety assurance
program; and (3) assist industry in developing adequate test
methods.
In addition, we believe that the Congress should consider the
feasibility of requiring that all food eligible for import to the
United States--not just meat and poultry--be produced under
equivalent food safety systems.
We also believe that the problems associated with the current
fragmented system cannot be solved by individual agencies' efforts to
respond to internal and external critics. Instead, these problems
can be best addressed by a complete restructuring of the federal food
safety system for chemical residues and environmental contaminants.
As we have stated in other reports and testimonies,\1
food safety would be better assured if the Congress created a single
food safety agency responsible for carrying out the requirements of
cohesive food safety laws.
--------------------
\1 Food Safety and Quality: Uniform, Risk-Based Inspection System
Needed to Ensure Safe Food Supply (GAO/RCED-92-152, June 26, 1992);
Food Safety: A Unified, Risk-Based Food Safety System Needed
(GAO/T-RCED-94-233, May 25, 1994); Food Safety: A Unified,
Risk-Based System Needed to Enhance Food Safety (GAO/T-RCED-94-71,
Nov. 4, 1993).
AGENCY COMMENTS AND OUR
EVALUATION
---------------------------------------------------------- Chapter 6:3
We sought and received comments on a draft of this report from the
Environmental Protection Agency, the Food and Drug Administration,
the Department of Agriculture, and the Department of Commerce. USDA
generally agreed with the conclusions and recommendations presented
in this report. Commerce did not fully agree with our conclusions
and stated that better interagency coordination can rectify the
deficiencies of the current system. However, Commerce did agree with
our recommendations. Although EPA generally concurred with the
report's conclusions and findings, it did not agree that a single
food safety agency was needed to overcome the problems mentioned in
the report. EPA believes that an interagency council with working
groups can resolve these issues. We disagree with EPA that an
interagency council can resolve the structural weaknesses that we
have identified. While this council may be used as an interim
measure to improve communication between agencies, we have seen
little evidence to suggest that interagency working groups have been
effective in overcoming problems in the past. We therefore continue
to believe that a single food safety agency is the best approach.
All three agencies provided us with additional technical comments
that have been incorporated, as appropriate, throughout the report.
(Apps. IV, VI, and VII contain the full text of comments received
from these agencies and our response.)
The fourth agency that commented on a draft of this report, FDA, did
not concur with our conclusions and recommendations. FDA believes
that this report is based on outdated information and opinions and
perpetuates the public's misperception that the food supply may be
unsafe. We disagree with FDA's observations about this report.
While it is true that this report reiterates many of GAO's and
others' previously reported positions, the deficiencies identified in
this report were compiled largely from reports that were issued
during the last 4 years. Every effort was also made to obtain and
use the most current program-specific information available from the
agencies--either for fiscal year 1992 or 1993. Moreover, the purpose
of this report was to identify the structural and systemic weaknesses
in the federal legal and regulatory structure for monitoring
chemicals in food that have persisted over the past 2 decades, and
not to comment on the safety of specific chemicals or foods. The
deficiencies we have highlighted continue to exist today, despite
federal agencies' efforts to improve their programs. Many of these
problems are the result of the very laws that provide the framework
for the food safety system. These problems can never be completely
addressed by the agencies responsible for monitoring food and
ultimately have to be addressed by the Congress. FDA also provided
us with technical comments that have been incorporated throughout the
report, as appropriate. (See app. V for the full text of FDA's
comments and our response.)
We also contacted five organizations that represent various sectors
of the food production and marketing industry for their views on the
current federal system to monitor chemicals in food. Officials that
we spoke to at these organizations included the Senior Vice President
for Regulatory Affairs, American Meat Institute; the Vice President
of Technology and Science, Food Marketing Institute; the Technical
Adviser, National Broiler Council; the Executive Vice President,
National Fisheries Institute; and the Senior Vice President, National
Food Processors Association. Officials from these organizations told
us that monitoring chemicals in food should generally be an industry
responsibility. These officials provided us with numerous examples
of how the food industry has developed and implemented many
HACCP-based programs, although the federal government did not require
it to do so. They generally believed that the current system is
adequate and did not think that any major changes were necessary to
better ensure the safety of the food supply. While the industry
officials concurred with our conclusions and recommendation on the
need to have industry-implemented HACCP programs, we disagree with
their comments that this should be solely an industry responsibility
with little federal government involvement. We believe that without
federal government oversight, consumers have no assurance that the
food industry has implemented effective HACCP plans that will
adequately ensure food safety.
RISK ASSESSMENT PROCESS
=========================================================== Appendix I
Risk assessment is a relatively new discipline; federal agencies did
not start conducting regular risk assessments until the late 1970s.
In 1983, the National Academy of Sciences (NAS) published a risk
assessment paradigm,\1 which is generally accepted by federal
agencies as a valuable approach to conducting risk assessments. The
NAS paradigm defines four fields of analysis of risk assessment: (1)
hazard identification--the determination of whether a particular
chemical is or is not causally linked to a particular health effect;
(2) dose-response assessment--the determination of the relationship
between the magnitude of exposure and the probability of occurrence
of the health effects in question; (3) exposure assessment--the
determination of the extent of human exposure before or after the
application of regulatory controls; and (4) risk
characterization--the description of the nature and magnitude of
human risk, including the attendant uncertainty, based on an analysis
of the first three fields.
Each phase of the risk assessment process relies on a different set
of information, and each consists of a number of decision points when
inferences must be made from available evidence on the risks to human
health. The inferences that an agency makes are based on both
scientific judgment and policy choices. The final conclusions of the
risk assessment process are ultimately based on the data, analysis,
and inferences made during each of the four phases. Figure I.1 shows
the process and data applied at every step for chemicals used on
food.
Figure I.1: The Risk
Assessment and Agency
Decision-Making Processes
(See figure in printed
edition.)
Even under the best conditions, risk assessment decisions are fraught
with scientific uncertainty because of inherent limitations in
knowledge and methodologies. These limitations result in uncertain
estimates of risk even with the most complete, accurate, and reliable
data. Some limitations occur because ethical considerations prevent
deliberate human experimentation with potentially dangerous
chemicals; therefore, the current methodology used to determine
chemical risk is based on the extrapolation of animal studies to
humans. However, projection from animal studies is an uncertain
process at best because (1) interspecies differences must be
considered when extrapolating results from animals to humans; (2)
higher doses are used in animal tests than humans are expected to
ingest and therefore these results must be extrapolated to lower
doses that correspond to anticipated human exposure levels; (3)
susceptibility to toxic effects varies from individual to individual;
and (4) there may be a need to extrapolate from the route of exposure
used in the laboratory experiment to a different, more likely route
of human exposure. Consequently, risk assessors must rely on
numerous assumptions when extrapolating animal studies to humans.
One agency official told us that the risk assessment process is more
art than science and does not guarantee the same results every time.
Additional limitations in the risk assessment process result from the
lack of information on the synergistic effects of separate chemical
substances. Generally, agencies do not determine whether the
simultaneous action of separate substances produces a health effect
that is greater than the sum of the individual ingredients. The
potential risks to humans from multiple exposure to many different
chemicals is also believed to be of some concern. It is conceivable
that relatively safe chemicals may interact, even at low doses, to
form a new substance that is toxic. However, federal agencies do not
take these joint exposures into account when approving a chemical for
use on food. According to the Environmental Protection Agency (EPA),
the immense number of possible chemical residue combinations that
could be ingested by people eating different diets makes this a
difficult task.
--------------------
\1 Risk Assessment in the Federal Government: Managing the Process,
(National Research Council, National Academy Press, Washington, D.C.,
1983).
RESULTS OF FDA'S AND USDA'S
CHEMICAL MONITORING PROGRAMS
========================================================== Appendix II
This appendix provides a list of the Food and Drug Administration's
(FDA) chemical monitoring programs for fiscal year 1992 and the total
number of samples that were tested and found violative under each
program. This appendix also provides a list of the number of
compounds tested for by the Food Safety and Inspection Service (FSIS)
under its National Residue Program (NRP) for meat and poultry in
calendar year 1992, the number of analyses performed, and the results
of the analyses. In addition, the appendix includes the residue
testing results from the Agricultural Marketing Service's (AMS)
Pesticide Data Program (PDP).
Table II.1
FDA's Compliance Programs and
Assignments, Fiscal Year 1992
Analyz Violat Analyz Violat
Compliance program/assignment ed ive ed ive
------------------------------------------------ ------ ------ ------ ------
Pesticides and industrial chemicals in domestic 7,784 180
foods
Pesticides in Mexican produce 2,653 173
Pesticides and industrial chemicals in 210 2
aquaculture products
Incidence and level monitoring for pesticide \a \a \a \a
residues in domestic/imported pears
Incidence and level monitoring for pesticide \a \a \a \a
residues in domestic/imported tomatoes
Pesticides in imported cocoa products 38 1
Chemical contaminants in bottom-dwelling seafood 107 4
from Massachusetts Bay
Pesticides and industrial chemicals in imported 6,118 269
foods
Survey of imported tiger shrimp for 49 2
chloramphenicol
Methylmercury in fresh/frozen shark and 83/36 29/8 31/70 2/21
swordfish
================================================================================
Total 8,220 223 8,959 468
--------------------------------------------------------------------------------
\a These two assignments were issued in June 1992. Because it was
late in the fiscal year, FDA did not include the samples taken for
these programs.
Table II.2
FSIS' Testing Results for Chemicals in
Meat and Poultry, Calendar Year 1992
Analyz Violat Analyz Violat
Chemical tested for ed ive ed ive
------------------------------------------------ ------ ------ ------ ------
Antibiotics and sulfanomides 356,53 4,647 9,420 7
4
Arsenic 1,180 4 744 0
Benzimidazoles 2,627 0 1,765 0
Carbadox 650 0 342 0
Carbamates 1,092 0 12 0
Chlorinated hydrocarbons & organophosphates 7,329 10 3,683 0
Clenbuterol 1 0 0 0
Diethylstilbestrol 10 0 12 0
Halofuginone 623 1 16 0
Ivermectin 3,273 9 1,823 0
Nitroimidazoles 0 0 30 0
Pyrethrins 663 0 390 1
Zeranol 8 0 11 0
================================================================================
Total 373,99 4,671 18,248 8
0
--------------------------------------------------------------------------------
\a The number of samples analyzed and found violative for each
compound includes samples analyzed under all three NRP
programs--surveillance, monitoring, and individual enforcement
testing.
Table II.3
Results of AMS' Statistically Based
Residue Testing for Pesticides in Fruits
and Vegetables, Calendar Year 1992
Number
of Number
Number Number sample of
of of s with sample
pestic sample positi s that
ides s ve were
detect analyz residu violat
Commodity ed ed es ive
---------------------------- ------ ------ ------ ------
Apples 25 567\a 502 4
Bananas 4 564\a 209 5
Celery 21 508 409 17
Green beans 24 466\a 279 22
Grapefruit 9 567 260 0
Grapes 21 552 381 5
Lettuce 19 565 201 5
Oranges 11 569 329 0
Peaches 22 360 307 4
Broccoli 7 153 54 0
Carrots 10 153 88 1
Potatoes 16 568 404 0
============================================================
Total 49\b 5,592 3,423 63
------------------------------------------------------------
\a An additional 158 samples were tested for benomyl/thiabendazole
only: 51 samples of apples, 51 samples of bananas, and 56 samples of
green beans.
\b This number represents the total number of different pesticides
detected.
GAO AND OTHER PRODUCTS ON THE
FEDERAL CHEMICAL MONITORING SYSTEM
========================================================= Appendix III
GAO REPORTS AND TESTIMONIES
------------------------------------------------------- Appendix III:1
Total Diet Study And Other Pesticide and Residue Surveillance
Programs (B-164031(2), Feb. 23, 1972).
Lack of Authority Limits Consumer Protection: Problems in
Identifying and Removing From the Market Products Which Violate the
Law (B-164031(2), Sep. 14, 1972).
Federal Pesticide Registration Program: Is It Protecting the Public
and the Environment Adequately From Pesticide Hazards?
(GAO/RED-76-42, Dec. 4, 1975).
Use of Cancer-Causing Drugs in Food-Producing Animals May Pose Public
Health Hazard: The Case of Nitrofurans (GAO/MWD-76-85, Feb. 25,
1976).
Federal Efforts to Protect the Public From Cancer-Causing Chemicals
Are Not Very Effective (GAO/MWD-76-59, June 16, 1976).
Need to Establish Safety and Effectiveness of Antibiotics Used in
Animal Feeds (GAO/HRD-77-81, June 27, 1977).
Food and Drug Administration's Program for Regulating Imported
Products Needs Improving (GAO/HRD-77-72, July 5, 1977).
Special Pesticide Registration by the Environmental Protection Agency
Should Be Improved (GAO/CED-78-9, Jan. 9, 1978).
Federal Efforts to Regulate Pesticide Residues in Food (105119, Feb.
14, 1978).
Problems in Preventing the Marketing of Raw Meat and Poultry
Containing Potentially Harmful Residues (GAO/HRD-79-10, Apr. 17,
1979).
Better Regulation of Pesticide Exports and Pesticide Residues in
Imported Food Is Essential (GAO/CED-79-43, June 22, 1979).
Need for Comprehensive Pesticide Use Data (GAO/CED-80-145, Sept. 30,
1980).
Further Federal Action Needed to Detect and Control Environmental
Contamination of Food (GAO/CED-81-19, Dec. 31, 1980).
Stronger Enforcement Needed Against Misuse of Pesticides
(GAO/CED-82-5, Oct. 15, 1981).
Improved Management of Import Meat Inspection Program Needed
(GAO/RCED-83-81, June 15, 1983).
Legislative Changes and Administrative Improvements Should Be
Considered for FDA to Better Protect the Public From Adulterated Food
Products (GAO/HRD-84-61, Sept. 26, 1984).
Imported Wines: Identifying and Removing Wines Contaminated With
Diethylene Glycol (GAO/RCED-86-112, Mar. 4, 1986).
Pesticides: EPA's Formidable Task to Assess and Regulate Their Risks
(GAO/RCED-86-125, Apr. 18, 1986).
Pesticides: Better Sampling and Enforcement Needed on Imported Food
(GAO/RCED-86-219, Sept. 26, 1986).
Pesticides: Need to Enhance FDA's Ability to Protect the Public From
Illegal Residues (GAO/RCED-87-7, Oct. 27, 1986).
Federal Regulation of Pesticide Residues in Food (GAO/T-RCED-87-21,
Apr. 30, 1987).
Imported Meat and Livestock: Chemical Residue Detection and the
Issue of Labeling (GAO/RCED-87-142, Sept. 30, 1987).
Seafood Safety: Seriousness of Problems and Efforts to Protect
Consumers (GAO/RCED-88-135, Aug. 10, 1988).
Imported Foods: Opportunities to Improve FDA's Inspection Program
(GAO/HRD-89-88, Apr. 28, 1989).
Reregistration and Tolerance Reassessment Remain Incomplete for Most
Pesticides (GAO/T-RCED-89-40, May 15, 1989).
Guidelines Needed for EPA's Tolerance Assessments of Pesticide
Residues in Food (GAO/T-RCED-89-35, May 17, 1989).
Domestic Food Safety: FDA Could Improve Inspection Program to Make
Better Use of Resources (GAO/HRD-89-125, Sept. 27, 1989).
Food Safety and Quality: Five Countries' Efforts to Meet U.S.
Requirements on Imported Produce (GAO/RCED-90-55, Mar. 22, 1990).
Five Latin American Countries' Controls Over the Registration and Use
of Pesticides (GAO/T-RCED-90-57, Mar. 28, 1990).
Food Safety: Issues USDA Should Address Before Ending Canadian Meat
Inspections (GAO/RCED-90-176, July 6, 1990).
Food Safety and Quality: FDA Surveys Not Adequate to Demonstrate
Safety of Milk Supply (GAO/RCED-91-26, Nov. 1, 1990).
U.S. Food Exports: Five Countries' Standards and Procedures for
Testing Pesticide Residues (GAO/NSIAD-91-90, Dec. 20, 1990).
Food Safety and Quality: Who Does What in the Federal Government
(GAO/RCED-91-19B, Dec. 21, 1990).
Pesticides: EPA's Use of Benefit Assessments in Regulating
Pesticides (GAO/RCED-91-52, Mar. 7, 1991).
Food Safety and Quality: Stronger FDA Standards and Oversight Needed
for Bottled Water (GAO/RCED-91-67, Mar. 12, 1991).
Pesticides: Food Consumption Data of Little Value to Estimate Some
Exposures (GAO/RCED-91-125, May 22, 1991).
Pesticides: EPA's Repeat Emergency Exemptions May Provide Potential
for Abuse (GAO/T-RCED-91-83, July 23, 1991).
Nutrition Monitoring: Mismanagement of Nutrition Surveys Has
Resulted in Questionable Data (GAO/RCED-91-117, July 26, 1991).
Pesticides: EPA Lacks Assurance That All Adverse Effects Data Have
Been Reviewed (GAO/T-RCED-92-16, Oct. 30, 1991).
Pesticides: Better Data Can Improve the Usefulness of EPA's Benefit
Assessments (GAO/RCED-92-32, Dec. 31, 1991).
Food Safety and Quality: FDA Needs Stronger Controls Over the
Approval Process for New Animal Drugs (GAO/RCED-92-63, Jan. 17,
1992).
Food Safety: USDA Data Program Not Supporting Critical Pesticide
Decisions (GAO/IMTEC-92-11, Jan. 31, 1992).
Food Safety: Difficulties in Assessing Pesticide Risks and Benefits
(GAO/T-RCED-92-33, Feb. 26, 1992).
Food Safety: USDA's Data Program Not Supporting Critical Pesticide
Decisions (GAO/T-IMTEC-92-9, Mar. 11, 1992).
Pesticides: USDA's Pesticides Residue Research Project
(GAO/T-RCED-92-38, Mar. 11, 1992).
Pesticides: Comparison of U.S. and Mexican Pesticide Standards and
Enforcement (GAO/RCED-92-140, June 17, 1992).
Food Safety and Quality: Uniform, Risk-Based Inspection System
Needed to Ensure Safe Food Supply (GAO/RCED-92-152, June 26, 1992).
Pesticides: 30 Years Since Silent Spring--Many Long-Standing
Concerns Remain (GAO/T-RCED-92-77, July 23, 1992).
Food Safety and Quality: FDA Strategy Needed to Address Animal Drug
Residues in Milk (GAO/RCED-92-209, Aug. 5, 1992).
Food Safety and Quality: USDA Improves Inspection Program for
Canadian Meat, but Some Concerns Remain (GAO/RCED-92-250, Aug. 26,
1992).
Pesticides: Adulterated Imported Foods Are Reaching U.S. Grocery
Shelves (GAO/RCED-92-205, Sep. 24, 1992).
Pesticides: Information Systems Improvements Essential for EPA's
Reregistration Efforts (GAO/IMTEC-93-5, Nov. 23, 1992).
Pesticides: U.S. and Mexican Fruit and Vegetable Pesticide Programs
Differ (GAO/T-RCED-93-9, Feb. 18, 1993).
Food Safety: Inspection of Domestic and Imported Meat Should Be
Risk-Based (GAO/T-RCED-93-10, Feb. 18, 1993).
Food Safety: Building a Scientific, Risk-Based Meat and Poultry
Inspection System (GAO/T-RCED-93-22, Mar. 16, 1993).
Pesticides: Pesticide Reregistration May Not Be Completed Until 2006
(GAO/RCED-93-94, May 21, 1993).
Pesticides: Limited Testing Finds Few Exported Unregistered
Pesticide Violations on Imported Foods (GAO/RCED-94-1, Oct. 6,
1993).
Pesticides: Reregistration Delays Jeopardize Success of Proposed
Policy Reforms (GAO/T-RCED-94-48, Oct. 29, 1993).
Food Safety: A Unified, Risk-Based System Needed to Enhance Food
Safety (GAO/T-RCED-94-71, Nov. 4, 1993).
Pesticides: Options to Achieve a Single Regulatory Standard
(GAO/RCED-94-57, May 13, 1994).
Food Safety: A Unified, Risk-Based Food Safety System Needed
(GAO/T-RCED-94-233, May 25, 1994).
Food Safety and Quality: USDA's Role Under the National Residue
Program Should Be Reevaluated (GAO/RCED-94-158, Sept. 26, 1994).
USDA'S OFFICE OF INSPECTOR
GENERAL REPORTS
------------------------------------------------------- Appendix III:2
Food Safety and Inspection Service: Meat and Poultry Inspection
Program (Audit Report No. 38607-1-At, Sept. 26, 1986).
Food Safety and Inspection Service: Audit of the Imported Meat
Process (Audit Report No. 38002-2-Hy, Jan. 14, 1987).
Food Safety and Inspection Service: Monitoring and Controlling
Pesticide Residues in Domestic Meat and Poultry Products (Audit
Report No. 38609-1-At, Nov. 1989).
Food Safety and Inspection Service: Follow-Up Audit of the Imported
Meat Process (Audit Report No. 38002-4-Hy, Mar. 29, 1989).
Food Safety and Inspection Service: Monitoring of Drug Residues
(Audit Report No. 24600-1-At, Sept. 30, 1991).
STUDIES BY CONGRESS, SCIENTIFIC
ORGANIZATIONS, AND OTHERS
------------------------------------------------------- Appendix III:3
Risk Assessment in the Federal Government: Managing the Process
(Commission on Life Sciences, National Research Council, Mar. 1,
1983).
Meat and Poultry Inspection: The Scientific Basis of the Nation's
Program (Commission on Life Sciences, National Research Council,
1985).
Antibiotic Use in Animals and Humans: Health Implications
(Congressional Research Service, Order Code IB85076, Dec. 16, 1985).
Poultry Inspection: The Basis for a Risk Assessment Approach
(Commission on Life Sciences, National Research Council, 1987).
Wastes in Marine Environments (Office of Technology Assessment,
Report No. OTA-0-334, Apr. 1987).
Pesticide Monitoring Program: Developing New Methods to Detect
Pesticide Residues in Food (Congressional Research Service, Report
No. 87-413 SPR, Apr. 24, 1987).
Regulating Pesticides in Food: The Delaney Paradox (Board on
Agriculture, National Research Council, May 20, 1987).
Meat and Poultry Inspection: Background and Current Issues
(Congressional Research Service, Report No. 89-448 ENR, Aug. 1,
1989).
Pesticide Residues in Food: Technologies for Detection (Office of
Technology Assessment, Report No. OTA-F-398, Oct. 1988).
Intolerable Risk: Pesticides in Our Children's Food (Natural
Resources Defense Council, Feb. 27, 1989).
Federal Food Safety Laws and Activities (Congressional Research
Service, Report No. 89-607 ENR, Nov. 7, 1989).
Final Report of the Advisory Committee on the Food and Drug
Administration (Advisory Committee of the Food and Drug
Administration, U.S. Department of Health and Human Services, May
1991).
Seafood Safety (Food and Nutrition Board, Institute of Medicine,
National Academy of Sciences, 1991),
The Safety of Imported Foods (Congressional Research Service, Report
No. 91-644 SPR, Sept. 16, 1991).
HACCP (Hazard Analysis and Critical Control Point) in Meat, Poultry,
and Seafood Inspection (Congressional Research Service, Report No.
91-832 ENR, Oct. 22, 1991).
Proposed Changes to Policies Governing Pesticide Residues in Foods
(Congressional Research Service, Report No. 92-179 SPR, Feb. 14,
1992).
A New Technological Era for American Agriculture (Office of
Technology Assessment, Report No. OTA-F-474, Aug. 1992).
Seafood Inspection Issues in the 102d Congress (Congressional
Research Service, Order Code IB92079, Oct. 15, 1992).
The Delaney Clause: The Dilemma of Regulating Health Risk for
Pesticide Residues (Congressional Research Service, Report No.
92-800 SPR, Nov. 9, 1992).
An Overview of Federal Food Safety Research: Including Research
Needs for the Future (Committee on Food, Agricultural, and Forestry
Research, Federal Coordinating Council for Science, Engineering, and
Technology, Jan. 7, 1993).
Pesticides in Children's Food (Environmental Working Group,
Washington, D.C., 1993).
What Americans Think About Agrichemicals--A Nationwide Survey on
Health, Environment, and Public Policy (Public Voice for Food and
Health Policy, Washington, D.C., Apr. 1993).
Pesticides in the Diets of Infants and Children (Board on Agriculture
and Board on Environmental Studies and Toxicology, Commission on Life
Sciences, National Research Council, 1993).
Issues in Risk Assessment (Board on Environmental Studies and
Toxicology, Commission on Life Sciences, National Research Council,
1993).
Researching Health Risks (Office of Technology Assessment, Report No.
OTA-BBS-571, Nov. 1993).
(See figure in printed edition.)Appendix IV
COMMENTS FROM THE ENVIRONMENTAL
PROTECTION AGENCY
========================================================= Appendix III
The following are GAO's comments on the Environmental Protection
Agency's letter dated August 23, 1994.
GAO COMMENTS
------------------------------------------------------- Appendix III:4
1. We have modified the report on the basis of the technical
comments that we received from EPA, as appropriate.
2. While we agree with EPA that establishing a single food safety
agency is no small task, we believe that this is the preferred
approach to effectively ensure the safety of the food supply. We
disagree with EPA's suggestion that an interagency council with
working groups can resolve the issues we have raised in this report.
An interagency council, by itself, cannot eliminate the
inefficiencies caused by fragmentation or eliminate the problems that
result from the inconsistent legal patchwork that undergirds the
current food safety system. Moreover, the persistent nature of the
problems we have identified and the limited evidence of successful
past attempts at setting up interagency bodies raises questions about
the feasibility of this approach. During our review, we found
examples of interagency working groups that had been set up in the
past to improve coordination and cooperation between agencies, but
which either lapsed into inaction because of a lack of commitment or
resources by the agencies involved or just became forums to
facilitate the exchange of information between agencies. Interagency
groups worked effectively only when they were established to respond
to urgent and life-threatening situations. As we have stated in this
and past reports, the preferred approach for better ensuring food
safety would be to create a single food safety agency and revise the
food safety laws to make them uniform and consistent.
(See figure in printed edition.)Appendix V
COMMENTS FROM THE FOOD AND DRUG
ADMINISTRATION
========================================================= Appendix III
(See figure in printed edition.)
(See figure in printed edition.)
(See figure in printed edition.)
(See figure in printed edition.)
See comment 7.
See comment 8.
See comment 10.
See comment 12.
(See figure in printed edition.)
See comment 17.
(See figure in printed edition.)
See comment 21.
(See figure in printed edition.)
(See figure in printed edition.)
See comment 32.
(See figure in printed edition.)
See comment 34.
See comment 36.
See comment 38.
(See figure in printed edition.)
See comment 39.
See comment 40.
See comment 41.
See comment 42.
See comment 44.
See comment 45.
See comment 46.
See comment 47.
(See figure in printed edition.)
The following are GAO's comments on the Food and Drug
Administration's letter dated August 5, 1994.
GAO COMMENTS
------------------------------------------------------- Appendix III:5
1. We disagree with the agency's statement that the information
contained in the report is outdated and does not support the
conclusions and recommendations. Although findings from over 90 GAO
and other investigations conducted over the past 20 years provide the
basis for much of this report, the issues highlighted in this report
were largely compiled from reports issued in the last 4 years. Every
effort was made to update the data and use only the most current
program-specific information available from the agencies--for either
fiscal year 1992 or 1993. In its written comments, FDA did not
provide us with any concrete examples of where we had used only
outdated information to support the conclusions of this report. We
also disagree with FDA's comment that the report does not reflect the
progress made by regulatory agencies. Throughout the report, we have
provided relevant examples of actions taken by federal agencies to
improve their programs.
Furthermore, while we recognize that all chemicals do not pose the
same level of risk, the intent of this report was not to address
chemical-specific issues or comment on the overall safety of the food
supply. It was also not the purpose of this report to "indict" all
federal programs, as FDA asserts. Instead, the objectives of this
review were to identify specific structural and systemic weaknesses
that hamper the effectiveness of the current federal food monitoring
system. Many of these weaknesses have persisted for over 2 decades,
despite the agencies' efforts to take corrective actions. The
persistence of these problems, as we point out in the report, is
indicative of fundamental weaknesses in the legal and regulatory
framework, which can only be overcome by congressional actions.
2. We have modified the report, as appropriate, to clarify the
differences between chemical residues and environmental contaminants.
3. GAO does not misunderstand the provisions of the FFDCA, as FDA
asserts. While we agree that the FFDCA places responsibility for
food safety on the industry, the law does not include requirements
for a HACCP-based monitoring system, as we have recommended to the
Congress. We believe that the Congress should amend the laws,
including the FFDCA, FMIA, and PPIA, to implement such a requirement.
Moreover, while we agree that FDA has been a key federal player in
the implementation of federal HACCP-based programs, we disagree with
FDA's assertion that it has been a leader in this area. We believe
that the food industry itself has taken the lead in developing and
implementing HACCP-based programs. A 20-year gap has occurred
between FDA's first implementation of a HACCP-based program for
low-acid canned foods and the 1994 proposal for a HACCP seafood
program. However, in the interim many sectors of the food industry
have developed and implemented HACCP-based systems as part of their
food production processes, without any mandatory requirements by the
federal government or FDA. Moreover, FDA's statement that it
requires a HACCP-based program for infant formula is incorrect.
According to an official in FDA's Division of Programs and
Enforcement Policy, Office of Special Nutritionals, the current
infant formula regulations are not HACCP-based. No change was made
to the report on the basis of FDA's comments on this issue.
4. We disagree with FDA's comment that it is "virtually impossible"
to require that all imported foods, not just meat and poultry, be
produced under equivalent food safety systems. Because we recognize
the differences in monitoring imported fruits and vegetables versus
meat and poultry, we have not suggested that the solutions to ensure
their safety must be identical, as FDA states. Rather, we believe
that given the unique problems of these types of foods, other
solutions are possible. For example, if FDA is seeking HACCP-based
systems for all domestic foods, as stated in its comments on this
report, then FDA will also have to require that imported products be
produced under HACCP-based systems. By implementing this
requirement, FDA is, in effect, ensuring that imported foods are
being produced under equivalent food safety systems. Otherwise,
imported products will not meet U.S. food safety standards.
5. We have modified the report to reflect FDA's comment.
6. We have modified the report to clarify this difference.
7. We disagree with FDA's comment that EPA is not a primary federal
agency responsible for monitoring chemicals in food. For this
report, we have defined the term "monitoring" in a much broader sense
than FDA has interpreted it; we include as part of this definition
all activities conducted by federal agencies to approve chemicals for
use in food; test food products for the presence of illegal
chemicals; enforce compliance with U.S. standards; and perform
research and development. In this context, EPA is a primary federal
agency responsible for monitoring chemicals in food because, among
other things, it ensures that only safe pesticides are approved for
and used on food and sets water quality standards that affect
drinking water and fish.
8. Changes made to the report under comment 6 should clarify this
statement.
9. We have modified the report to reflect FDA's comment.
10. We have modified the report to reflect FDA's comment.
11. See comment 3. We made no changes to the report on the basis of
FDA's comment on this issue.
12. This statement is a generalization of the facts reported in
chapter 5 of the report. The first part of the statement is valid
for all import programs, and we have qualified the second part of the
sentence because it applies only to some import programs.
13. See comment 6. We have also modified the report to include
FDA's other comments.
14. We have modified the report to reflect FDA's comment.
15. We have modified the report to reflect FDA's comment.
16. We have modified the report to reflect FDA's comment.
17. We have not changed the report because these facts are already
stated in chapter 1.
18. We have modified the report to reflect FDA's comment.
19. We disagree with FDA's statement that NASS and AMS do not have a
role in monitoring the food supply for illegal residues. As we have
explained in the report and in comment 7, our definition of
monitoring also includes the activities conducted by NASS and AMS.
In this context, NASS' pesticide usage data collection activities and
AMS' pesticide residue data collection and testing of egg products
for chemicals are relevant federal monitoring activities. We have
made no change to the report on the basis of FDA's comment on this
issue.
20. We disagree with FDA's comment that our statement on the
widespread recognition of problems with the current system is
unsubstantiated. As we point out in this report, GAO and other
organizations have been reporting for over 20 years on numerous
program-specific problems that continue to limit the effectiveness of
the current system. We also disagree with FDA's comment that this
report perpetuates "unfounded" concerns and will lead to further
regulatory imbalances and skewed resource allocation toward perceived
rather than real problems. As we have stated in this report and in
past reports, the imbalances in the current regulatory system are
primarily the result of the fragmented legal structure. This
fragmentation has resulted in the division of responsibility among
multiple federal agencies, which in turn has resulted in both gaps
and duplication in federal food safety monitoring activities.
Furthermore, in this report as in past reports, we continue to
emphasize the need for a uniform food safety system that is
risk-based and under which resources are allocated according to the
greatest risk. No changes were made to the report on the basis of
FDA's comments on this issue.
21. We disagree with FDA's new position that there is no duplication
between USDA's PDP and FDA's residue programs. Since no changes have
occurred in either agency's program, we do not believe that the
duplication has been eliminated. We have modified the report to
reflect this comment.
22. We have made no change to the report on the basis of FDA's
comment because, during our review, FDA could not provide us with any
evidence that the pilot program was started after the agency had
first compared the results of USDA's statistically based data program
with FDA's nonstatistical sampling program. Any comparisons that
were made after the pilot program was implemented do not change this
fact.
23. We disagree with FDA's comment that the section on Inadequate
Data Management Practices is incorrect. This section does not
discuss FDA's pesticide data management system, as asserted by the
agency. Instead, it reviews deficiencies in other specifically
mentioned data bases. The requirements of the Pesticide Monitoring
Improvements Act and FDA's fulfillment of these requirements are also
discussed in detail in chapter 5 of this report. No change was made
to the report on the basis of FDA's comment.
24. We recognize that the proposed legislation addresses this
concern and have referred to it, where appropriate, throughout
chapter 3. No change was made to the report on the basis of FDA's
comment.
25. We disagree with FDA's comment that the FFDCA provides a
specific standard to regulate environmental contaminants. As stated
in the report, although FDA may set tolerance levels for
environmental contaminants under the food safety provisions of the
FFDCA, it is not required to do so and, as a result, has established
few tolerances for these chemicals. We have modified the report to
clarify this issue.
26. We have made no changes to the report in response to FDA's
comment because this paragraph in the report is an introductory
paragraph. Greater detail and the examples suggested by FDA are
included in the relevant sections following the introductory
paragraph.
27. We have modified the report to reflect FDA's comment.
28. We have made no changes to the report in response to FDA's
comment because we believe that we have adequately identified the
differences in EPA's and FDA's legislative responsibilities in both
chapters 1 and 3. Furthermore, the purpose of this paragraph in the
report is to highlight the duplication between two agencies providing
similar kinds of information to the states. We recognize that both
agencies have different responsibilities for ensuring the safety of
fish, but we do not believe that these differences justify the lack
of a unified effort when the agencies are providing information to
the states.
29. We agree that this section of the report is a reiteration of
GAO's past positions on the issue, and we discuss the proposed
legislation at the end of this section, as it applies to these
concerns. However, until action is taken by the Congress on the
proposed legislation or any other bill that addresses these concerns,
we believe that these issues will continue to be relevant. No change
was made to the report on the basis of FDA's comment.
30. We disagree with FDA that this report and past reports have not
acknowledged that the intent of the extra-label drug use policy is to
provide for the emergency and rare use of unapproved animal drugs to
treat sick animals. Past GAO reports, and this one in chapter 4,
have all recognized the need for an extra-label drug use policy.
However, our concern has been and continues to be with FDA's
inability to prevent the widespread misuse of this policy by both
veterinarians and farmers. No changes were made to the report on the
basis of FDA's comment.
31. We recognize the problems that FDA faces in collecting the data
needed to support the establishment of tolerances for environmental
contaminants and have modified the report to include these concerns.
However, the purpose of this section of the report is to identify how
the lack of a specific legal requirement to set tolerances for
environmental contaminants has resulted in few tolerances for these
contaminants and that agencies generally respond to such hazards only
in life-threatening situations.
32. We have modified the report to reflect FDA's comment.
33. We disagree with FDA's comment that our conclusion about the
inability of federal agencies to test the food supply for unsafe
residues is unfounded. Chapter 4 of this report summarizes
significant deficiencies that continue to exist in the various
government programs in place to ensure that the food supply complies
with federal standards. We believe that as long as the federal
government continues to rely primarily on end-product testing as the
means of enforcing compliance with federal standards, federal
enforcement activities will continue to be inadequate and
inefficient. While it is true that FDA's testing results show a low
level of illegal residue violations for pesticides, these results may
not represent the true incidence of residues in the total food supply
because they are not statistically valid. Moreover, we do not
believe that low violation rates should justify the continuation of
the existing monitoring system that catches problems at the end of
the production process. To better ensure the safety of the food
supply, federal agencies should move toward HACCP-based approaches
that emphasize building safety into the whole production process. No
changes were made to the report on the basis of FDA's comment.
34. We have modified the report to reflect FDA's comment.
35. We disagree with FDA's comment that the report unfairly compares
FDA's and USDA's statistics. We have presented the facts in the same
manner that the agencies report the results of their testing programs
to the Congress and the public. In addition, the report notes that
these results are not comparable. We believe that FDA's attempt to
estimate a comparable number of pesticide analyses conducted every
year is misleading as well as inaccurate. According to data provided
to us by FDA, the six multi-residue methods that are used by the
agency's pesticide residue program individually can detect 13, 19,
24, 102, 128, and 258 pesticides, respectively. Without identifying
how many of the 12,000 samples were tested by each of these methods,
it is not possible to estimate the number of comparable pesticide
analyses that FDA performed. As we have reported in the past, most
samples are not tested for pesticides using all six multi-residue
methods. Moreover, about 8 percent of FDA's samples are tested using
single-residue or selective multi-residue methods, which are capable
of detecting only one or a few selected compounds. No changes were
made to the report on the basis of FDA's comment.
36. We have modified the report to reflect FDA's comment.
37. We have not made any changes to the report in response to FDA's
comment because the focus of this section is on domestic pesticide
usage data. A discussion of FDA's import pesticide usage data is
included in chapter 5 of the report.
38. We have modified the report to reflect FDA's comment.
39. We have made no change to the report on the basis of this
comment because we do not believe that the level of coordination that
currently exists addresses the concerns that we have highlighted in
the report. Although the officials that we spoke to were aware of
test method development activities ongoing in other agencies, we
found no evidence to suggest that they were cooperating in a manner
that would result in the more efficient use of resources and improve
the federal government's test method development efforts.
40. We have modified the report to reflect FDA's comment.
41. We have made no change to the report on the basis of FDA's
comment because this discussion focuses on the lack of statistically
valid data and on the limitations in using these data to project the
general safety of the food supply.
42. We have included this information in the report.
43. We have modified the report to reflect FDA's comment.
44. We have modified the report to reflect FDA's comment.
45. We have not modified the report on the basis of FDA's comment
because we believe that we have adequately qualified our statement.
The report states that some import programs do not test for chemicals
used in foreign countries, and we have provided details on the
programs we are referring to.
46. We have modified the report on the basis of FDA's comment.
However, while the report recognizes that FDA has multiple sources of
information on foreign pesticide use, we also note that a 1993 report
from the Keystone Center, a nonprofit organization, specifically
states that these data sources have not been of much value to FDA in
targeting its import pesticide testing and recommends that the agency
pursue alternative sources of information.
47. We have modified the report to reflect FDA's comment.
48. We disagree with FDA's comment that our conclusion about FDA's
inability to take adequate enforcement action against violative
imports is unfounded. We have recognized in this report and in past
reports that FDA needs not only additional resources to inspect and
test imports, but also greater enforcement authorities. While we
agree that FDA's detention authority is a very powerful enforcement
tool, it alone is not adequate, because FDA must still rely on the
Customs Service to ensure that enforcement actions have been taken
against violative imports. As we have reported in the past,
enforcement often does not happen for a variety of reasons, including
poor coordination and differing priorities between the agencies.
Moreover, while FDA may test for a greater number of chemicals than
USDA, this testing is FDA's primary assurance that imported foods
meet U.S. standards. USDA, on the other hand, relies on testing
products at the port of entry only as a secondary control, because it
has other mechanisms in place in the country of origin to ensure the
safety of imported meat and poultry.
49. No changes were made to the report on the basis of FDA's
comment. The data that we have provided in appendix II appear as
they were reported by USDA. Under the USDA program, a violation
occurs when a residue is found that exceeds the tolerance levels set
by EPA, or when a residue is found for which there is no tolerance
for a particular crop. We believe that this is consistent with the
requirements of the FFDCA. FDA's comment on the USDA's role under
the PDP and FDA's role in determining whether a product is violative
or not, raises questions about duplication and lack of cooperation
and coordination between federal agencies. We believe that FDA's
comment provides another example of the unnecessary problems that
exist and the confusion that arises from the fragmentation of
responsibility among numerous agencies under the current system.
(See figure in printed edition.)Appendix VI
COMMENTS FROM THE U.S. DEPARTMENT
OF AGRICULTURE
========================================================= Appendix III
(See figure in printed edition.)
See comment 6.
(See figure in printed edition.)
See comment 8.
(See figure in printed edition.)
(See figure in printed edition.)
(See figure in printed edition.)
(See figure in printed edition.)
See comment 13.
(See figure in printed edition.)
(See figure in printed edition.)
(See figure in printed edition.)
The following are GAO's comments on the U.S. Department of
Agriculture's letter dated August 29, 1994.
GAO COMMENTS
------------------------------------------------------- Appendix III:6
1. We agree with USDA's statement and believe that the fragmentation
of responsibility among various agencies has largely contributed to
these problems. However, these concerns are more relevant to our
discussion in chapter 4 on the ineffectiveness of end-product testing
for ensuring compliance with federal standards. No changes were made
to the report on the basis of USDA's comment.
2. We agree with USDA's statement and have included this information
in chapter 5, where we discuss imported products in greater detail.
3. While we agree with USDA's comment that many consumers may be
under the impression that the federal government tests the entire
food supply, we have not seen any research or studies that have
actually shown this to be a fact. We have therefore not included
this statement in the report.
4. While we agree with USDA's statement, we have not included this
information in the report because naturally occurring toxins were not
included within the scope of this review.
5. We have modified the report to clarify this point.
6. We have not included this information in the report because
naturally occurring toxins were not part of our review.
7. Although FDA has apparently changed its position on whether
USDA's Pesticide Data Program duplicates its own programs, we still
question the need for two separate federal programs in the area of
pesticide residue monitoring. We have modified the report to reflect
these changes.
8. We have included this information in the report.
9. In our report entitled Food Safety: USDA's Role Under The
National Residue Program Should Be Reevaluated (GAO/RCED-94-158,
Sept. 26, 1994), we discuss in greater detail many of the issues
that USDA raises in its comments. As we stated in that report, the
list of 367 compounds is significant because it provides the basis
for establishing priorities and allocating resources for the National
Residue Program. If this list contains duplicative and/or historical
data, we believe that FSIS should quickly update it so that it can
provide meaningful information for making program decisions. We have
made no change to the report on the basis of USDA's comment about the
relation between multi-residue tests and low-ranked compounds. This
relationship is not the focus of the report. Rather, the report
focuses on how the lack of adequate multi-residue methods has impeded
federal efforts to detect all compounds of concern. Because of this
deficiency, the current system, which relies on end-product testing,
cannot adequately ensure the safety of the food supply. We have
modified the report to clarify the criteria used by USDA when it
makes decisions to rotate chemicals out of the plan.
10. We have made no changes to the report on the basis of USDA's
comment because the purpose of this section is to discuss how the
lack of statistically based data prohibits extrapolations of the
incidence of chemicals to the whole food supply.
11. In our report entitled Food Safety: USDA's Role Under the
National Residue Program Should Be Reevaluated (GAO/RCED-94-158,
Sept. 26, 1994), we discuss in greater detail many of the issues
that USDA raises in its comments. As we stated in that report, the
flaws that we found in USDA's sampling plan could result in biases
that would affect the statistical validity of the sample results.
Moreover, we stated that we were concerned that the manner in which
FSIS was reporting information on violations implied an overall
violation estimate that the sampling plan is not designed to report.
As a result, no changes were made to the report on the basis of
USDA's comment.
12. We disagree with USDA's suggested change to the report.
End-product testing, by itself, does not prevent contamination from
occurring. We agree with USDA that while end-product testing may be
one of the preventive measures if done prior to consumption, by
itself it cannot prevent problems. We have made no changes to the
report on the basis of USDA's comment.
13. We have modified the report to reflect USDA's revised data.
(See figure in printed edition.)Appendix VII
COMMENTS FROM THE U.S. DEPARTMENT
OF COMMERCE/ NATIONAL OCEANIC AND
ATMOSPHERIC ADMINISTRATION
========================================================= Appendix III
(See figure in printed edition.)
(See figure in printed edition.)
Now on p. 43.
(See figure in printed edition.)
See comment 4.
See comment 6.
(See figure in printed edition.)
(See figure in printed edition.)
The following are GAO's comments on the Department of Commerce's
letter dated August 26, 1994.
GAO COMMENTS
------------------------------------------------------- Appendix III:7
1. We have modified the report to address this concern and no longer
use the term chemical residues to include environmental contaminants,
as appropriate.
2. We have included this information in the report to reflect
Commerce's comment.
3. We have modified the report to reflect Commerce's comment.
4. We have modified the report to reflect Commerce's comment.
5. We have modified the report to reflect Commerce's comment.
6. We have added this information to the report.
7. We have included this information in the report.
MAJOR CONTRIBUTORS TO THIS REPORT
======================================================== Appendix VIII
RESOURCES, COMMUNITY AND ECONOMIC
DEVELOPMENT DIVISION, WASHINGTON,
D.C.
Edward M. Zadjura, Assistant Director
Anu K. Mittal, Evaluator-in-Charge
Michael J. Rahl, Senior Evaluator
Carol Herrnstadt Shulman, Reports Analyst