Food Safety: USDA's Role Under the National Residue Program Should Be
Reevaluated (Chapter Report, 09/26/94, GAO/RCED-94-158).
The Agriculture Department's National Residue Program, which monitors
chemical residues in meat and poultry, has weaknesses in testing and
sampling as well as in the support it receives from regulatory agencies.
The Agriculture Department does not adjust its testing of imported meat
and poultry in response to known problems with heavy metal residues or
animal drug and pesticide compounds not allowed in the United States but
used by exporting nations. Thus, the Agriculture Department does not
know the extent to which potentially harmful residues may or not affect
the meat and poultry supply. In addition, because thousands of
agricultural chemicals and new compounds are introduced annually, the
Agriculture Department may not always have complete information on
chemical residues or the potential hazard such residues may present to
consumers. These weaknesses could be overcome if some processes were
strengthened. Any improvements made, however, would not address the
basic problem with the program: reliance on detecting residues at the
end of the production process to ensure safety rather than on preventing
these problems from occurring in the first place.
--------------------------- Indexing Terms -----------------------------
REPORTNUM: RCED-94-158
TITLE: Food Safety: USDA's Role Under the National Residue Program
Should Be Reevaluated
DATE: 09/26/94
SUBJECT: Contaminated foods
Consumer protection
Quality assurance
Statistical methods
Food inspection
Meat packing industry
Hazardous substances
Pesticide regulation
Product safety
Agricultural chemicals
IDENTIFIER: USDA National Residue Program
USDA Compound Evaluation System
USDA Residue Violation Information System
USDA Meat and Poultry Inspection Program
FDA Contamination Response System
FSIS Hazard Analysis and Critical Control Point System
Beef Quality Assurance Program
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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 - USDA'S ROLE UNDER
THE NATIONAL RESIDUE PROGRAM
SHOULD BE REEVALUATED
GAO/RCED-94-158
Reevaluating the National Residue Program
Abbreviations
=============================================================== ABBREV
ARS - Agricultural Research Service
CES - Compound Evaluation System
CSRS - Cooperative State Research Service
EPA - Environmental Protection Agency
FDA - Food and Drug Administration
FSIS - Food Safety and Inspection Service
GATT - General Agreement on Tariffs and Trade
HACCP - Hazard Analysis and Critical Control Point
HHS - Department of Health and Human Services
NRP - National Residue Program
RVIS - Residue Violation Information System
USDA - U.S. Department of Agriculture
Letter
=============================================================== LETTER
B-256719
September 26, 1994
The Honorable Edolphus Towns
Chairman, Human Resources and Intergovernmental
Relations Subcommittee
Committee on Government Operations
House of Representatives
Dear Mr. Chairman:
In response to your request, this report examines the effectiveness
of the U.S. Department of Agriculture's National Residue Program.
This program is intended to ensure that the nation's meat and poultry
supply is free of potentially harmful chemical residues.
This report makes recommendations for improving the program to the
Secretary of Agriculture and presents an alternative approach for the
Congress to consider to increase the program's effectiveness in
detecting and controlling potentially harmful residues.
As arranged with your office, unless you publicly announce its
contents earlier, we plan no further distribution of this report
until 7 days after the date of this letter. At that time, we will
send copies to the appropriate congressional committees, departmental
secretaries, agency heads, and other interested parties. Copies will
also be made available on request.
This work was performed under the direction of John W. Harman,
Director of Food and Agriculture Issues, who can be reached at (202)
512-5138 if you or your staff have any questions. Other major
contributors to this report are listed in appendix V.
Sincerely yours,
Keith O. Fultz
Assistant Comptroller General
EXECUTIVE SUMMARY
============================================================ Chapter 0
PURPOSE
---------------------------------------------------------- Chapter 0:1
Meat and poultry can contain residues of drugs and pesticides used in
agricultural production, as well as industrial chemicals that find
their way into the food chain through environmental pollution. To
ensure that hazardous levels of these compounds do not contaminate
meat and poultry, the Food Safety and Inspection Service (FSIS)
within the Department of Agriculture (USDA) administers the National
Residue Program.
At the request of the Chairman, Human Resources and Intergovernmental
Relations Subcommittee, House Committee on Government Operations, GAO
examined whether (1) FSIS' National Residue Program can assure the
public that the nation's meat and poultry supply is free of
potentially hazardous chemical residues and (2) assistance from the
Environmental Protection Agency (EPA) and the Food and Drug
Administration (FDA) within the Department of Health and Human
Services (HHS) is adequate to support the National Residue Program's
needs. As agreed with the Chairman's office, GAO also examined the
value of a different regulatory approach--one that requires industry
to have residue prevention, detection, and control programs that are
monitored by the federal government.
BACKGROUND
---------------------------------------------------------- Chapter 0:2
FSIS, which is responsible for ensuring that both domestic and
imported meat and poultry products are safe and free of potentially
harmful chemical residues, conducts thousands of residue tests to
ensure that U.S. standards are met. The National Residue Program is
designed to identify and select chemical compounds that could present
health-based concerns to consumers of meat and poultry, sample and
test meat and poultry for residues of these compounds, and take
enforcement action against those who market products that contain
potentially hazardous levels of these compounds. To operate the
program, FSIS relies on assistance from other agencies, primarily
EPA, which sets residue limits and provides other information for
pesticides approved for domestic use, and FDA, which does the same
for approved animal drugs. FSIS, in turn, collects samples of meat
and poultry from slaughter plants and at ports of entry throughout
the United States and analyzes them against established residue
limits. Violations are referred to FDA for investigation and
enforcement action at the farm/producer level.
RESULTS IN BRIEF
---------------------------------------------------------- Chapter 0:3
Testing conducted under the National Residue Program each year is not
comprehensive, and the methodology used to select samples is flawed.
Also, FSIS does not adjust its testing of imported meat and poultry
to encompass known problems with heavy metal residues or animal drug
and pesticide compounds not allowed in the United States but used by
exporting nations. Thus, FSIS does not know the extent to which
potentially harmful residues may or may not exist in the meat and
poultry supply.
In addition, because thousands of agricultural chemicals are used
worldwide and new compounds are introduced annually, FSIS may not
always have complete information on chemical residues or the
potential hazard such residues may present to consumers. For
example, there are gaps in knowledge about the health and
environmental effects of some compounds previously approved for use
under less stringent scientific standards. Also, although FDA is
principally responsible for investigating and taking enforcement
action on the residue violations referred by FSIS, resource
constraints and legislative restrictions limit FDA's ability to do
so.
While steps can be taken to strengthen the National Residue Program,
recent industry initiatives suggest that a risk-based approach to
residue prevention, detection, and control that is an integral part
of the production process may better ensure the safety of meat and
poultry than the current approach that relies on testing end
products. FSIS recognizes the value of this approach and has begun
to design systems incorporating it. However, FSIS' resources might
be more effectively used if, subject to FSIS' assistance and
oversight, industry were responsible for establishing and operating
quality assurance systems for preventing, detecting, and controlling
residues. FSIS could selectively monitor the effectiveness of
industry programs and assist industry by developing information on
compounds in use and test methods.
PRINCIPAL FINDINGS
---------------------------------------------------------- Chapter 0:4
NRP IS NOT COMPREHENSIVE AND
IS FLAWED
-------------------------------------------------------- Chapter 0:4.1
To obtain reliable results from the National Residue Program, FSIS
must ensure that compounds presenting the greatest potential concern
are identified, ranked in terms of potential threat, and tested on a
priority basis. However, about two-thirds of the 367 compounds
already identified as being of potential concern have not been ranked
because insufficient resources have been dedicated to the task. USDA
now states that the list of compounds needs to be updated and that
FSIS plans to devote more resources to the ranking task. However, it
will still take many years to rank the remaining compounds.
Furthermore, only 24 of the 56 compounds tested in 1992 were high
priority. Also, while certain exporting countries periodically
report to FSIS that they have found high numbers of heavy metal
residue violations in their testing, no U.S. regulatory limits have
been established for heavy metal residues in meat and poultry, and
FSIS does not routinely test either imported or domestic products for
these residues. In addition, FSIS limits its residue testing of
imported meat and poultry to the same animal drug and pesticide
compounds it tests for domestically--even though exporting nations
may use compounds not approved or banned for use in the United
States.
To provide credible results, FSIS must test product samples that are
selected randomly using commonly accepted statistical techniques.
However, FSIS does not consistently follow random sampling
procedures. FSIS also does not adjust its sampling of some species
to compensate for climatic/geographic and seasonal changes in
slaughter rates and animal drug use. Other inconsistencies in FSIS'
sampling of different animal species and chemical compounds
potentially skew test results. Consequently, the National Residue
Program's test results are not necessarily representative of the true
situation with residues.
LIMITATIONS EXIST IN THE
SUPPORT PROVIDED BY OTHER
AGENCIES
-------------------------------------------------------- Chapter 0:4.2
EPA and FDA are not able to provide all the information and
assistance FSIS needs for the National Residue Program. For example,
questions have been raised about the health and environmental effects
of many of the pesticides previously approved by EPA, as well as
about the regulatory limits set for their residues in
foods--including meat and poultry. Although EPA is reevaluating
these pesticide products on the basis of current scientific
standards, EPA estimates that it will take until 2006 to finish the
reregistration process. Also, because of limited resources, FDA
investigated only about 20 percent of the 21,439 violations reported
to it by FSIS from 1989 through 1992. Only one prosecution resulted
from these investigations.
AN ALTERNATIVE REGULATORY
APPROACH MIGHT PROVE MORE
EFFECTIVE
-------------------------------------------------------- Chapter 0:4.3
Rather than rely on the present federal system of testing end
products, some sectors of the meat and poultry industry have
integrated residue prevention, detection, and control programs as a
quality control function at critical points throughout their
production processes. These process-oriented, risk-based systems are
designed to guard against potentially hazardous residues in products
from the farm through the slaughterhouse. FSIS recognizes the value
of this approach and now intends to incorporate it into the federal
meat and poultry inspection program. However, it is currently
uncertain whether FSIS would retain the responsibility for day-to-day
residue detection. Alternatively, FSIS could delegate this
responsibility to industry and adopt an oversight role, much as FDA
has done in regulating canning operations for low-acid foods.
Although FDA conducts limited testing and reviews program records,
the canning industry is responsible for day-to-day testing and for
otherwise ensuring that the canning methods used prevent
contamination from the bacterium that causes botulism.
RECOMMENDATIONS
---------------------------------------------------------- Chapter 0:5
While improvements to the National Residue Program could
incrementally increase its effectiveness, GAO believes that
fundamental changes to the basic regulatory approach now used are
needed. GAO believes that a risk-based approach, established by
industry with FSIS' assistance and oversight, and operated by
industry with FSIS' monitoring, would be a more effective
alternative. However, such a fundamental change requires
congressional approval before it can be implemented. To strengthen
the existing program in the interim, GAO makes recommendations to the
Secretary of Agriculture in the areas of compound selection,
sampling, testing, and reporting. (See ch. 2.)
MATTERS FOR CONGRESSIONAL
CONSIDERATION
---------------------------------------------------------- Chapter 0:6
An industry-operated, risk-based system that integrates residue
prevention, detection, and quality control from the farm through the
slaughterhouse, established with FSIS' assistance and oversight,
would be more effective than the current federal program. Therefore,
the Congress may wish to direct FSIS to adopt such an approach while
maintaining an oversight role to monitor the effectiveness of
industry programs. To ensure that FSIS could effectively carry out
these responsibilities, the Congress may also wish to provide FSIS
with additional access to industry records and enforcement authority.
AGENCY COMMENTS
---------------------------------------------------------- Chapter 0:7
GAO obtained written comments on a draft of this report from USDA,
HHS, and EPA. GAO also obtained the views of officials from two
industry trade groups that collectively represent over 80 percent of
the meat and poultry industry. All three agencies and the industry
trade groups fundamentally agreed that a process-oriented, risk-based
approach that tries to prevent residue problems from occurring would
be more effective than the current system that relies on limited
testing of end products to detect residues after the fact. USDA
disagreed with GAO's conclusion on the reliability of the current
program, stating that for individual animal species and compounds,
the results may be reliable. However, GAO's main point was that
since their actual reliability is unknown, these results should not
be aggregated in a manner that suggests they are representative of
the entire meat and poultry supply. USDA agreed on this point. HHS
stated that the report took a narrow view of FDA's enforcement
actions and cited the use of injunctions against repeat violators as
an example of its preferred approach. GAO disagrees with HHS on this
point because FDA's own data show that few investigations are
actually done and that only 12 injunctions were obtained in 4 years
even though almost 2,300 repeat violators were reported during that
period. Changes were made throughout the report in response to
technical comments provided by all three agencies. In addition, the
agencies' comments are presented in their entirety, along with GAO's
responses, in appendixes II, III, and IV. Industry endorsed the use
of a process-oriented, risk-based system and noted that it was
already moving in this direction. Industry's views are discussed in
chapter 4.
INTRODUCTION
============================================================ Chapter 1
Modern agricultural practices--including the use of chemical
fertilizers, pesticides, and animal drugs--have enabled farmers to
produce a domestic food supply that is abundant, diverse, and
available to the consumer at relatively low cost. While beneficial
in many ways, these practices may leave chemical residues on or in
food. The safety of these residues has concerned consumers,
especially during the last 5 years. Chemical issues generally fall
below biological hazards, such as microbial contamination, when
public health issues are ranked by experts. While the health effects
of biological hazards are usually immediate and acute, chemical
hazards may take a lifetime to manifest themselves as disease or may
produce genetic changes in the next generation. Therefore, each is
recognized as a separate and important source of potential public
health problems and must be dealt with appropriately within the
context of a risk-based food safety program.
The federal government expends considerable effort and resources each
year on programs designed to monitor and control the levels of
chemical residues in the nation's food supply.\1 In fiscal year 1992,
the U.S. Department of Agriculture's (USDA) Food Safety and
Inspection Service (FSIS) spent about $30 million on its National
Residue Program (NRP), the principal federal effort to prevent
contamination from chemical residues in meat and poultry. Chemical
residues can get into meat and poultry when animals are exposed to
environmental contaminants, pesticides, or animal drugs used to
prevent or treat illnesses and/or promote growth.
--------------------
\1 FSIS carries out its meat and poultry inspection responsibilities
under the Federal Meat Inspection Act, as amended (21 U.S.C. 601 et
seq.) and the Poultry Products Inspection Act, as amended (21 U.S.C.
451 et seq.). In addition, under the Talmadge-Aiken Act of 1962 (7
U.S.C. 450), states may opt to perform their own inspections of meat
and poultry slaughtering and processing at plants within their own
borders. Such state inspections are performed in accordance with
federal standards by state employees under cooperative agreement with
FSIS. These plants are considered to be federally inspected and
therefore may sell their products in interstate commerce.
THE NATIONAL RESIDUE PROGRAM
---------------------------------------------------------- Chapter 1:1
Established in 1967, the NRP is designed to detect, measure, reduce,
and prevent potentially harmful residue levels of drugs, pesticides,
and other chemicals in meat and poultry products destined for human
consumption. Under the program, samples of domestic and imported
meat and poultry are collected at slaughtering establishments and
ports of entry throughout the United States and are analyzed for
residues of animal drugs, pesticides, and other chemical
contaminants. Each year, the NRP's results are presented in FSIS'
Domestic Residue Data Book and are reported to the Congress as part
of USDA's annual report on meat and poultry inspection. In calendar
year 1992, meat and poultry samples were tested for a total of 56
different chemical compounds, covering 14 classes of animal drugs and
pesticides. Overall, a total of 373,990 domestic and 18,171 import
residue analyses were performed.\2
FSIS' Compound Evaluation System (CES) is the primary basis for the
NRP. This system is used to determine (1) whether a compound is
likely to produce a potentially hazardous residue in meat and
poultry, (2) how great a hazard the residue might produce--on a scale
from A (high) to D (low), and (3) how likely humans are to be exposed
to the residue--on a scale from 1 (likely) to 4 (unlikely). A "Z"
designation is assigned to either (or both) the hazard and the
exposure category if there is insufficient information to rank a
compound. FSIS developed the CES in 1985 to focus NRP resources on
the most potentially important residue problems. FSIS' analysis of
these factors is based, in part, on such information as scientific
assessments and other data obtained from the Environmental Protection
Agency (EPA) and the Food and Drug Administration (FDA) in the
Department of Health and Human Services (HHS), as well as from other
USDA agencies.
The CES ranking serves two primary purposes. First, the ranking is
used to set priorities for the compounds to be included in the NRP
for testing. Second, the ranking is used to set priorities for the
compounds that need to have tests developed. The compounds selected
for testing in the monitoring portion of the program must (1) leave a
detectable residue in meat and poultry, (2) have regulatory limits
(tolerances) for the given residues in meat and poultry, (3) have a
CES ranking, and (4) have suitable regulatory test methods for
detecting, quantifying, and confirming the residues in question.
Under the monitoring portion of the NRP, tissue samples are to be
selected randomly from healthy-looking animals during the
slaughtering process. These tissue samples are analyzed for chemical
residues, and the results are used to develop profiles for given
animal species/populations and chemical compounds on a national,
annual basis. Monitoring, however, is not designed to stop meat and
poultry containing potentially hazardous residues from reaching the
food supply. The products tested under this program normally pass on
to market before their test results are known.
Although the monitoring program is not designed to stop meat and
poultry with potentially hazardous residues, producers identified as
residue violators during monitoring must submit a sample of their
animals (up to 15) for preclearance testing before any more can be
offered for food purposes. FSIS will continue to require
preclearance testing until it is satisfied that the violator has
demonstrated compliance with residue standards. Also, as animals go
through the slaughtering process, FSIS inspectors identify
ill-looking animals and animals with drug injection marks for
individual enforcement testing. These animals do not enter the food
supply until the results of residue testing are known. Individual
enforcement testing is also conducted on animal species with
suspected or known residue problems. For example, young calves
(known as bob calves) have a history of drug residue problems and are
therefore sampled more intensively.
Violators identified in any testing component of the NRP are notified
by FSIS of their violation by letter, and copies of these letters are
sent to EPA, FDA, and the states. Depending on the
nature/seriousness of the violations, EPA and FDA may initiate
investigative action and implement regulatory or educational efforts
of their own with identified violators. Information on violations is
also entered into FSIS' automated Residue Violation Information
System to assist FSIS in identifying repeat violators. FDA also has
access to this system.
--------------------
\2 The multiple-residue methods used by FSIS will generally provide
test results for a number of compounds within the same chemical
family. Therefore, the total number of analyses reported each year
significantly exceeds the number of meat and poultry samples actually
selected for testing under the NRP.
COORDINATION WITH OTHER
AGENCIES
---------------------------------------------------------- Chapter 1:2
While primarily responsible for the NRP and its day-to-day
operations, FSIS depends on other agencies to provide regulatory
limits for residues of chemical compounds, information, and support
for the NRP's efforts. For example, EPA is responsible for assessing
the potential health and environmental effects of pesticides marketed
for use in the United States under the Federal Insecticide,
Fungicide, and Rodenticide Act, as amended (7 U.S.C. 136 et seq.),
and for establishing allowable levels for their residues in
foods--including meat and poultry--under the Federal Food, Drug, and
Cosmetic Act, as amended (21 U.S.C. 301 et seq.). Similarly, as
part of its responsibilities under the Federal Food, Drug, and
Cosmetic Act, FDA ensures the accuracy and integrity of safety and
effectiveness data submitted by animal drug sponsors and establishes
tolerances (or other regulatory limits) for animal drug residues, as
well as for environmental contaminants, in foods, including meat and
poultry. FDA is also responsible for testing for residues in fruits,
vegetables, and other foods (except meat and poultry) and for taking
enforcement action against violators of established residue
regulatory levels. FSIS uses the regulatory levels established by
EPA and FDA as the standards against which it tests meat and poultry
for pesticide, animal drug, and other residues under the NRP.
EPA and FDA also assist FSIS in attempting to identify the chemical
compounds in use whose residues may present hazards to consumers of
meat and poultry. For instance, EPA and FDA participate in an annual
Surveillance Advisory Team meeting during which chemical compounds
are recommended for inclusion in the NRP. FDA also participates with
FSIS in the Interagency Residue Control Group, which deals with
residue issues in general, including animal drug residues in meat and
poultry. Also, both EPA and FDA are parties to a Memorandum of
Understanding with FSIS to coordinate regulatory activities on
pesticide, animal drug, and environmental contaminant residues in
foods.
OBJECTIVES, SCOPE, AND
METHODOLOGY
---------------------------------------------------------- Chapter 1:3
In connection with an ongoing investigation of chemical residues in
the U.S. food supply, the Chairman, Human Resources and
Intergovernmental Relations Subcommittee, House Committee on
Government Operations, asked GAO to examine whether (1) FSIS' NRP can
assure the public that the nation's meat and poultry supply is free
of potentially hazardous chemical residues and (2) program assistance
from EPA and FDA is adequate to support FSIS' NRP needs. Also, as
agreed with the Chairman's office, GAO examined the value of a
different regulatory approach--one that requires industry to have
residue prevention, detection, and control programs that are
monitored by the federal government.
To address these objectives, we interviewed and obtained
documentation from USDA, EPA, and FDA officials. We reviewed
legislation, policies, procedures, regulations, and agency documents
on meat and poultry inspection, as well as past reports by USDA's
Office of Inspector General, the National Research Council, the
Office of Technology Assessment, and the Congressional Research
Service. We also visited one FSIS area office, one FSIS regional
office, and one FSIS laboratory to discuss their activities under the
NRP, and eight meat and poultry plants across the nation to determine
how residue samples were taken.
To determine the extent to which assurances can be made on the basis
of the NRP's results, we interviewed program officials in FSIS and
obtained documentation on the universe of chemical compounds of
concern for meat and poultry; the process for identifying, setting
priorities for, and selecting specific compounds from that universe
for testing under the NRP; and the availability of acceptable test
methods for detecting those compounds and/or their chemical
by-products in meat and poultry. We also discussed test method
development needs and issues with FSIS, the Agricultural Research
Service, and the Cooperative State Research Service within USDA, and
FDA.
We used generally accepted statistical standards to assess the
adequacy of the NRP's sample size, the randomness of the program's
sample selection, and the limitations of the program's results. We
also compared the compounds selected for testing in calendar years
1989 through 1992 and their respective priority rankings with the
number and rankings of chemical residues of concern identified by
FSIS.
To determine whether the information and support provided by EPA and
FDA meets the NRP's needs, we reviewed the Memorandum of
Understanding among USDA, EPA, and FDA on activities for regulating
residues from pesticides, drugs, and environmental contaminants that
may adulterate meat and poultry; minutes from the Interagency Residue
Control Group and the Surveillance Advisory Team on the NRP's
operations, and information on the actions taken by EPA and FDA in
response to FSIS' residue violation referrals. We also interviewed
FSIS, EPA, and FDA officials on the NRP's process for selecting
chemical compounds, assessing their risks, and/or developing methods
of testing for them.
We obtained information on industry programs from interviews with
industry trade officials, conferences, trade journals, and other
publications. We also interviewed officials from the American Meat
Institute and the National Broiler Council to obtain industry views
on the need for industry-led, risk-based Hazard Analysis and Critical
Control Point (HACCP) systems for residue prevention and control, as
well as on the associated roles of industry and government under such
an approach. Together, these two organizations represent over 80
percent of the meat and poultry industry.
We obtained written comments on a draft of this report from USDA,
EPA, and FDA. These comments were summarized and incorporated into
the report as appropriate and are presented in their entirety, along
with GAO's responses, in appendixes II, III, and IV. We performed
our work between August 1992 and July 1994 in accordance with
generally accepted government auditing standards.
NATIONAL RESIDUE PROGRAM IS NOT
COMPREHENSIVE AND IS FLAWED
============================================================ Chapter 2
The NRP's test results cannot reliably be used to assure the public
that the meat and poultry supply is free of potentially hazardous
residues for two major reasons. First, the NRP's testing is not
comprehensive--only a relatively small number of the chemical
compounds identified as capable of leaving residues in meat and
poultry are tested for each year. Second, there are flaws in the
NRP's sampling methodology and implementation that may bias the
results obtained and reported for the compounds that are tested. As
a result, the information that USDA reports to the Congress each year
may not present an accurate picture of the extent to which
potentially hazardous residues exist in the meat and poultry supply.
MOST COMPOUNDS IDENTIFIED AS
CAPABLE OF LEAVING RESIDUES IN
MEAT AND POULTRY ARE NOT TESTED
---------------------------------------------------------- Chapter 2:1
The NRP's testing is adversely affected by many problems and does not
include most of the compounds identified by FSIS as capable of
leaving residues in meat and poultry. Over two-thirds of these
compounds have yet to be evaluated by FSIS under its Compound
Evaluation System (CES) to determine (1) the degree of hazard they
may present to consumers of meat and poultry and (2) the priority
they should receive under the NRP either in testing for their
presence or in developing test methods for them, if needed. At the
same time, tests are not conducted for the residues of some
high-priority compounds because acceptable tests do not exist.
Furthermore, residues of animal drugs used in an extra-label\1
manner may not always be detected under the NRP. Finally, imported
meat and poultry are not tested for residues of heavy metals or
unapproved and/or banned compounds even though such residues may be
present in them.
--------------------
\1 The use of an animal drug in a manner other than that specified on
the FDA-approved label is called an extra-label use and is a
violation of the Federal Food, Drug, and Cosmetic Act.
RANKING PROCESS IS
BACKLOGGED
-------------------------------------------------------- Chapter 2:1.1
Under the NRP, compounds identified as having the potential to leave
residues in meat and poultry are evaluated and prioritized by FSIS
under the CES to determine the relative hazard and exposure threat
they present to consumers of meat and poultry. Then the compounds
are assigned rankings. The CES rankings are important because FSIS
uses them to set priorities for selecting and testing specific
residues under the NRP and to start developing tests for
high-priority compounds if acceptable tests are not available.\2
However, although 367 compounds have been identified by FSIS as
potentially presenting residue concerns for meat and poultry, 240
(almost two-thirds) had not been evaluated and assigned hazard and
exposure rankings under the CES as of the 1993 NRP plan.
The CES ranking effort has become backlogged because (1) ranking
chemical compounds according to hazard and exposure potential is
inherently difficult and time-consuming and (2) FSIS has not
dedicated the resources needed to complete the ranking in a timely
fashion. An FSIS official in the Residue Evaluation and Planning
Division told us that it can take as long as 5 months to rank a
compound under CES, depending on the volume and currency of the
scientific information available. However, at the time of our
review, only three FSIS personnel were assigned to perform the CES
rankings. Only six compounds were ranked for the 1992 NRP and three
for the 1993 NRP. FSIS also intends to develop CES rankings for two
compounds that were dropped from testing after no violations were
found for them in 5 consecutive years.
In written comments on this report, USDA questioned the importance of
testing many of the compounds currently included in the list of
compounds considered for NRP testing. According to USDA, there is
considerable duplication in the list; many unranked compounds are
detected by the multi-residue test methods used for other compounds;
some of the compounds are indistinguishable from compounds that
naturally occur in animals; and many of the unranked compounds are no
longer of concern for various reasons. This contention is
inconsistent with FSIS' expressed intention to increase the resources
dedicated to the CES ranking process so that 10 compounds can be
ranked each year. If USDA is correct, then the list needs to be
updated to remove compounds that are no longer considered important
and to add any new compounds that should be considered for ranking.
FDA and EPA together approve about 30 new compounds each year, many
of which have agricultural uses. As a result, even after updating
the list, FSIS may still take many years to rank the remaining
compounds on the list.
--------------------
\2 According to FSIS' criteria, compounds having CES rankings of A-1
through A-3, B-1, B-2, and C-1 are considered as "high priority" and
are to be selected for NRP testing--or for test development if an
acceptable method of testing for the compound does not exist.
LACK OF TEST METHODS LIMITS
TESTING FOR COMPOUNDS
-------------------------------------------------------- Chapter 2:1.2
According to FSIS, for the agency to select a compound for testing
during NRP monitoring, FSIS must be able to reliably detect its
residue in meat and poultry using a multiple-residue test method--a
test capable of simultaneously detecting several residues within the
same chemical family.\3 However, tests developed by compound
producers/sponsors to meet EPA's or FDA's approval requirements
usually detect only the residue of the compound for which they are
seeking approval in the commodity on which the compound is to be
used. In these cases, FSIS must modify the approved test or develop
a new test that is acceptable and practical for use in testing for
the compound during NRP monitoring.
FSIS officials said that test development is time-consuming and
resource-intensive, sometimes taking 18 months or more to complete
for each compound. FSIS officials told us that FSIS laboratories
cannot quickly address all NRP test development needs because of
resource constraints and competing priorities, such as analyzing
compounds for the NRP, analyzing microbiological hazards for FSIS,\4
and reviewing the performance of and the scientific standards used by
private laboratories under contract to FSIS.
However, despite the importance of test development and the scarcity
of resources available to develop tests, laboratory resources
available for the NRP are not always applied to the highest-priority
needs. For instance, of the 48 compounds that FSIS ranked as having
high priority for testing in the 1992 NRP, 12\5 did not have tests
that FSIS considered acceptable or practical. However, although 27
compounds were recommended for test method development during the
period from 1993 through 1998, only 2 are high priority. Of the
remaining 25 compounds, none meets FSIS' priority criteria for test
development, and 21 have not been ranked under the CES.
--------------------
\3 To be selected for monitoring testing, a compound should also have
an established tolerance or other regulatory limit, as well as a
high-priority CES ranking.
\4 FSIS does not have a routine, statistically based monitoring
program to test raw meat and poultry for microbiological hazards at
individual plants. However, in fiscal year 1993, FSIS established a
program to test about 3,000 samples for microbiological pathogens in
steers and heifers. This program, if implemented annually, could
further constrain the laboratory resources available to the NRP.
\5 In commenting on this report, USDA indicated that after issuing
the 1992 NRP, it developed tests for 2 of the 12 high-priority
compounds, was attempting to develop tests for 3 others, and no
longer considered 1 other compound a concern because FDA had revoked
its use.
RESIDUES FROM SOME
EXTRA-LABEL DRUG USES MAY
NOT BE DETECTED
-------------------------------------------------------- Chapter 2:1.3
Any use or intended use of an animal drug on a food-producing animal
in a manner other than that specified on the FDA-approved label is
considered an extra-label use and a violation of the Federal Food,
Drug, and Cosmetic Act. Veterinarians and others resort to
extra-label drug use in order to treat or prevent the suffering and
death of animals when approved products and dosages have proven
ineffective or simply do not exist for the medical problem at hand.
Because FDA believes that in some cases extra-label use may be the
only effective treatment, FDA allows the practice when it is
performed under a veterinarian's care and steps are taken to ensure
that unsafe residue levels do not result.
Studies have shown extra-label use to be widespread, frequently
occurring without a veterinarian's involvement. As a result, the
time needed to ensure the dissipation of potentially harmful residues
from animals treated in an extra-label manner is often not determined
or followed. Furthermore, as FDA stated in its January 1992 task
force report on extra-label use, "to compile a list of drugs which
might be used in an extra-label manner would encompass nearly all
drugs currently being marketed."\6 FDA is concerned about extra-label
use that goes beyond the parameters of its discretionary enforcement
policy because such use could endanger public health by exposing
consumers to residues that have not been shown to be safe.
Compounds are primarily selected for NRP monitoring on the basis of
the residues that are likely to result from their approved uses.
However, some extra-label uses are detected under NRP monitoring when
multi-residue test methods detect the residues of compounds not
approved for use in the species tested or when testing for a given
compound is extended to an unapproved species. Extra-label uses are
also detected when particular compounds are targeted for testing
under NRP exploratory programs. However, unless FSIS knows what
compounds are being used in an extra-label manner, as well as how,
where, and when they are being used, and specifically tests for those
uses, some extra-label residues are likely to go undetected. Such
information is not readily available to FSIS. It is therefore
unlikely that the current system of testing animals at the time of
slaughter could ever completely ensure that all residues from the
extra-label use of animal drugs are detected in meat and poultry.
--------------------
\6 Report of the Enforcement Task Force (Extra-Label Use), Department
of Health and Human Services, FDA (Jan. 17, 1992).
IMPORTED PRODUCTS ARE NOT
TESTED FOR SOME POTENTIAL
HAZARDS
-------------------------------------------------------- Chapter 2:1.4
Each year about 4 to 6 percent of the U.S. meat and poultry supply
is imported from other nations. FSIS requires the countries
exporting meat and poultry to the United States to test their
products for residues under programs that are at least equal to the
U.S. program.\7 FSIS also "reinspects" samples of imported meat and
poultry for residues when these products enter the United States to
monitor the effectiveness of foreign residue testing. These efforts,
however, do not encompass all potentially hazardous residues that may
be in imported meat and poultry because FSIS' testing is generally
limited to the same compounds tested for in domestic meat and poultry
under the NRP. Hence, unless included in domestic testing, FSIS'
import testing does not include (1) pesticide and animal drug
compounds used by foreign nations that are not approved for or are
banned from use in the United States and (2) heavy metal residues
that exporting nations have detected as a potential problem.
According to FSIS, foreign nations must identify compounds used in
agricultural production, including those that are not approved for or
are banned from use in the United States, as part of the initial
certification process that enables them to export meat and poultry to
the United States. However, rather than test imported meat for
unapproved and banned compounds, FSIS reviews the residue testing
programs, test methods, and other safeguards used by these countries,
as well as the test results, and if it is satisfied with these
programs, it relies on them to ensure that no residues of unapproved
or banned compounds are present in the meat and poultry exported to
the United States. FSIS personnel in the Foreign Programs Division
also told us that it would be difficult to test imports for these
residues because the internal organs used for such tests are
generally not exported with the meat; despite efforts to keep abreast
of the compounds being used, FSIS does not have complete knowledge of
these compounds; and tests are not available to detect many of them.
FSIS officials also told us that testing imported meat and poultry
for residues of compounds other than those tested for domestically
could cause international trade problems. According to these
officials, if FSIS tested for and found residues of unapproved or
banned compounds in imported shipments and rejected them, the same
treatment could be applied to U.S. exports, which may contain
compounds approved for use in the United States but not in other
countries.
With regard to heavy metal residues, from at least 1989 through 1992,
five of the largest meat and poultry exporting nations to the United
States have periodically reported to FSIS that their domestic testing
found heavy metal residues in excess of their domestic standards.
However, FSIS does not routinely test domestic or imported products
for heavy metal residues because no U.S. regulatory limits have been
established for them in meat and poultry,\8 and there is no official
basis for testing or taking action on them.
Domestic meat and poultry have periodically been "surveyed" under the
NRP for heavy metal residues, and an FSIS study of several types of
heavy metal residues published in 1992 concluded that, with the
possible exception of lead and cadmium, the need to establish
regulatory limits for domestic meat and poultry was questionable.\9
Nevertheless, the health hazards of heavy metals such as lead and
cadmium are well known. In fact, the United States has acted in
other areas to prevent the ingestion of these residues, banning the
use of lead in gasoline and drinking water systems and of cadmium
compounds in pesticides.\10 Restrictions have also been placed on the
use of lead in paint and on utensils used for food and drink.
As a result of our inquiries, FSIS asked FDA to review FSIS' past
findings on some heavy metal residues and assist FSIS in setting
regulatory limits for those residues in animal tissues, should FDA
determine that such limits are needed.\11 According to an FDA
Programs and Environmental Policy Division official, FDA is currently
developing risk-assessment information for FSIS on the heavy metal
residue data referred to it, as requested. This official also said
that while FDA would provide guidance and assistance, the actual
establishment of regulatory limits for these residues in meat and
poultry was an FSIS risk-management responsibility. However, in
commenting on this report, the Department of Health and Human
Services (HHS) stated that FDA is responsible for establishing
regulatory limits for heavy metal residues if such limits are needed.
HHS also stated that FDA could set action levels for such residues by
issuing compliance policy guides, rather than following the more
time-consuming process that requires public notice and comment for
regulatory limits established under the Administrative Procedures Act
(5 U.S.C. 553). However, action levels are not legally binding and
can, and have been, successfully challenged.
According to FSIS program documentation, the purpose of the import
testing program is to provide an independent check to ensure that
foreign residue detection and control efforts are operating
effectively. Although FSIS officials state that imported meat and
poultry would be difficult to test without the internal organs
typically used for residue testing, FSIS is able to test imported
meat and poultry for compounds included in the domestic testing
program and occasionally finds violative residues as a result.
However, because FSIS does not test for unapproved and/or banned
compounds, it cannot independently ensure that meat and poultry
exported to the United States by nations using such compounds contain
no residues of these compounds--as required by law. Under the
legislation governing federal responsibilities for ensuring food
safety, any food, domestic or imported, that contains any residue of
a compound that has been banned or whose safety has not been
determined and approved by the United States is considered to be
adulterated and cannot enter the food supply. Furthermore, without
testing imported meat and poultry for the residues of unapproved
and/or banned pesticides and animal drugs that exporting nations are
using, as well as for the heavy metal residues identified as a
potential problem, FSIS cannot independently ensure that potentially
hazardous levels of these residues are not entering the domestic meat
and poultry supply through imported products.
--------------------
\7 In order to export meat and poultry to the United States, foreign
countries must have inspection/residue detection programs that, after
review, are deemed by FSIS to be at least equal to those of the
United States. As part of the effort to ensure this, FSIS requires
exporting nations to provide information about their agricultural
practices, chemical compounds used and tested for, and residue
testing program results. FSIS personnel also visit exporting nations
each year to review laboratory capabilities and procedures and sample
and perform residue testing at ports of entry to the United States on
imported meat and poultry. This testing is actually a "reinspection"
of products that have already been inspected and passed by the
foreign country. A recent U.S. Court of Appeals decision (992 F.2d
1359 (5th Cir., 1993)), which is to be reheard before the full court,
concluded that, for the purposes of the Poultry Products Inspection
Act, foreign countries must have programs that are identical to,
rather than at least equal to, U.S. programs.
\8 Official tolerances have been established for arsenic residues in
cattle, swine, horses, and poultry.
\9 "Chemical Contaminants Monitoring: Trace Metals in Edible Tissues
of Livestock and Poultry," AOAC International Journal, Vol. 75,
(Nov. 4, 1992).
\10 The use of lead-based paint is restricted/banned under the
Lead-Based Paint Poisoning Prevention Act, as amended (42 U.S.C.
4821 et seq.). Leaded gasoline is banned under the Clean Air Act, as
amended (42 U.S.C. 7545 (k)(2)(D)). The use of lead in public water
systems is banned under the Safe Drinking Water Act, as amended (42
U.S.C. 300g et seq.). The use of cadmium compounds in pesticides
for use on golf course fairways and home lawns was banned by EPA on
Aug. 19, 1987 (52 F.R. 31076).
\11 Under the Federal Food, Drug, and Cosmetic Act, as amended (21
U.S.C. 301 et seq.), FDA is responsible for approving and verifying
the safety and effectiveness of animal drugs and medicated feeds and
for establishing tolerances or other regulatory safety levels for
animal drug residues and environmental contaminants in foods,
including meat and poultry. FDA is also responsible for
investigating and taking enforcement action against those who violate
the residue standards it sets.
SAMPLING AND REPORTING FLAWS
---------------------------------------------------------- Chapter 2:2
The monitoring portion of the NRP may not provide reliable
information on the occurrence of residue violations in specific
animal populations on an annual, national basis because the NRP's
sampling practices and subsequent analyses do not always conform to
accepted statistical standards. We identified several problems with
the NRP sampling methodology: (1) random selection procedures are
not consistently followed; (2) climatic/geographic and seasonal
adjustments are not made for all affected species; and (3) similar
sampling rates are not used for all the species and compounds tested,
which may cause the violation rates calculated by FSIS to be skewed.
These sampling problems, when considered as a whole, raise questions
about the validity of the test results obtained through the NRP's
monitoring. Moreover, the program results that FSIS annually reports
to the Congress are misleading because test results that were
obtained by using dissimilar sampling rates are averaged to calculate
"overall" violation rates, import test results are omitted
altogether, and each year's program results are contrasted, without a
consistent basis of comparison, to imply year-to-year differences in
the overall violation rate found.
SAMPLE SELECTION IS NOT
CONSISTENTLY RANDOM
-------------------------------------------------------- Chapter 2:2.1
According to our observations of the selection of tissue samples at
several of the larger U.S. slaughtering plants, as well as follow-up
discussions with FSIS inspectors, samples are not always selected
randomly. When the selection is not random, or if the samples are
selected at a predictable time, the producer or the slaughterhouse
may be able to predetermine which animals will be sampled and thereby
undermine the accuracy of the random selection test results.
Although some FSIS inspectors had procedures for collecting random
samples, they did not always follow them because of their workload
and/or personnel shortages. For example, at some plants samples were
not collected within the time required by the random program; at
other plants, sampling was predictable--only in the morning or in the
afternoon. Also, some samples were selected on the basis of
individual judgment rather than random procedures (i.e., an inspector
randomly selected an animal lot but arbitrarily selected animals from
the lot). In addition, random sampling did not always occur
according to a plan because, in some cases, the plant was not
slaughtering the species to be sampled within the scheduled period.
Recognizing the problems associated with collecting random samples,
FSIS gives inspectors at federally inspected plants 7 days from the
date scheduled to take the sample; as long as the sample is taken
within the planned 7-day period, it is considered timely.
FSIS officials acknowledge that to the extent that some samples are
not selected randomly, or the time of sampling is predictable, test
results could be biased for some locations at given times. However,
they point out that the samples tested for the NRP are collected on
all species slaughtered, at numerous plants, in all regions, all year
long, and they question the degree to which these problems affect the
NRP's results overall.
CLIMATIC/GEOGRAPHIC AND
SEASONAL ADJUSTMENTS ARE NOT
MADE
-------------------------------------------------------- Chapter 2:2.2
The validity of the sampling results may be diminished because FSIS
does not adjust its sampling plan for climatic/geographic variations
in the use of some compounds or the seasonal slaughter of some
species. Climatic/geographic and seasonal considerations can be
important for some of the species tested by FSIS. For instance,
animal deworming compounds are used more frequently in warmer seasons
and regions of the country than in colder seasons and regions. In
addition, slaughter rates for some of the species sampled and tested
under FSIS' NRP monitoring plan can vary significantly by season.
Furthermore, the use of animal drugs to promote and maintain animal
health may be at its greatest during peak slaughter seasons.
FSIS officials said that making climatic/geographic adjustments for
all species would increase program costs, and they questioned whether
such adjustments would provide any significant additional information
about the population sampled. These officials also said that animals
are sometimes brought to slaughter plants from various geographic
regions, and it would therefore be difficult to adjust sampling rates
to compensate for the climatic/geographic use of compounds. Also,
USDA stated, in commenting on this report, that sampling adjustments
are made for some species when officials believe that they are
warranted by variations in seasonal slaughter rates. USDA stated
that such adjustments are not made for species whose seasonal
slaughter rates do not differ greatly. USDA recognized that this
could cause a "slight bias" in the test results but stated that this
possibility must be balanced against the need to stabilize laboratory
workloads, generate and distribute necessary forms, and attend to
other concerns.
Nevertheless, to the extent that sampling rates are not adjusted to
compensate for these factors, an overrepresentation of samples from
off-seasons and an underrepresentation of samples from peak seasons
can distort the test results for the species sampled.\12
--------------------
\12 The need to adjust meat and poultry sampling rates for seasonal
and geographic factors was discussed in Food Safety and Inspection
Service Meat and Poultry Inspection (MPI) Program, USDA, Office of
Inspector General (38607-1-At, 1986).
SMALL SAMPLE SIZES AND
DIFFERENT SAMPLING RATES MAY
SKEW TEST RESULTS
-------------------------------------------------------- Chapter 2:2.3
The sampling plan for the monitoring portion of the NRP does not
ensure that FSIS can detect residue violations for all species tested
with the same degree of reliability.\13 For example, FSIS generally
tested enough samples of heavily slaughtered (major) species, such as
beef cattle, to be 95-percent confident that residues in excess of
established regulatory limits would be detected if they existed in 1
percent or more of the animals slaughtered. However, FSIS generally
tested too few samples of less commonly slaughtered (minor) species,
such as geese, to detect a residue problem with this same degree of
confidence.
In addition, when testing for a given compound, FSIS did not select
samples at the same rate for each of the animal species tested.
Also, it did not select samples to test for different compounds in
the same animal species at the same rates. Consequently, the test
results obtained may contain large sampling errors for the compounds
and species tested.
--------------------
\13 FSIS' random sampling program is designed to provide a 95-percent
probability that at least one residue violation will be detected when
1 percent or more of the animal population sampled exceeds
established regulatory limits. Exceptions are made for minor
species.
REPORTING OF NRP DATA
-------------------------------------------------------- Chapter 2:2.4
In reporting the NRP's domestic test results, FSIS combines and
averages the test data it obtains on compounds from different
species. In doing this, FSIS ignores differences in the sampling
rates used for each compound/species pair. This approach is not
methodologically sound and may bias the estimated violation rate.
For example, as part of the NRP's monitoring for 1992, FSIS tested
294 bob calves and 256 sows for the presence of nine specific
antibiotic residues and found four and zero violative samples,
respectively (a 1.36-percent violation rate for bob calves and a
0.00-percent violation rate for sows). Under FSIS' methodology, the
1.36-percent violation rate is significant--a 1.00-percent violation
rate indicates, at the 95-percent confidence level, that a residue
problem exists in at least 1.00 percent of the population sampled.
However, under FSIS' procedure, the "overall" violation rate for
these two species is only 0.73 percent--less than significant. By
averaging test results for the two species, the violation rate for
bob calves is reduced, the rates for sows is increased, and the
existence of an antibiotic residue problem for bob calves is masked.
In fact, using this procedure, FSIS reported that it found an overall
violation rate of 0.42 percent for antibiotic residues under its 1992
NRP monitoring program. However, results for nine antibiotics tested
actually included violation rates as high as 1.36 percent for bob
calves and 1.83 percent for market hogs.
Furthermore, residue problems disguised by potentially biased results
are compounded when yearly residue data are used to determine an
overall violation rate, which is then compared with previous years'
data in order to imply a change in the overall violation rate found.
By ignoring differences in the sampling rates used for each
compound/species pair, FSIS calculates a potentially biased estimate
of the overall yearly violation rate. Also, FSIS does not sample
each compound/species at the same rate each year, so each year's
result could be biased in a different direction. Therefore, FSIS has
no statistically valid basis for comparing overall violation rates
from one year to the other.
Finally, the results of testing imported meat and poultry are not
included in program results, even though these foreign products
constitute 4 to 6 percent of the U.S. meat and poultry supply and
are tested for residues in the same way as domestic meat and poultry
products are.
Using its annual test results, FSIS has made public statements
suggesting that the incidence of potentially hazardous chemical
residues in the meat and poultry supply are declining. For example,
in its first briefing on NRP operations, FSIS reported that only 0.30
percent of the samples tested in its 1990 monitoring program showed
illegal residue levels and that fewer violations were being found
every year. Again, in a similar public briefing in June 1992, FSIS
reported that only 0.26 percent of the samples tested in its 1991
monitoring program showed illegal residues, versus 0.30 percent in
1990, and stated that "the trend for the overall violation rate
continues downward. We are moving ever closer to our goal of zero
illegal residues in meat and poultry." In its 1992 report to the
Congress, FSIS again stated that, for 1991, NRP monitoring had found
residue violations in only 0.26 percent of the samples tested versus
the 0.30 percent found in 1990. Given the problems discussed above,
the data on which these statements were based are questionable.
Furthermore, FSIS program officials agree that NRP monitoring data
cannot be used to estimate the overall incidence of violative
residues in the meat and poultry supply.
CONCLUSIONS
---------------------------------------------------------- Chapter 2:3
FSIS' ability to ensure that the most serious compounds of concern
are being targeted and detected under the NRP is impaired by problems
in several critical program areas. The majority of the chemical
residues identified as being of potential concern to consumers of
meat and poultry have yet to be ranked for testing and may not be
ranked for many years, given the level of resources currently planned
for this task. Also, lack of adherence to the NRP's established
priority system further weakens the program because it causes scarce
resources for testing and test development to be spent on compounds
of questionable significance.
Furthermore, FSIS can do more to ensure that imported meat and
poultry, which annually constitute about 4 to 6 percent of the U.S.
meat and poultry supply, are free of the potential problem residues
identified by exporting countries. In addition, shortcomings in the
procedures used to sample meat and poultry, as well as the omission
of test results obtained for foreign products, jeopardize the
reliability of the program's results. While FSIS has used the NRP
monitoring data to imply that there is a downward trend in the
presence of potentially hazardous residue levels, program officials
agree that the data cannot be used for that purpose.
We believe that fundamental changes need to be made to the basic
regulatory approach now used by FSIS to ensure that potentially
hazardous chemical residues are not in the nation's meat and poultry
supply. These changes are discussed in detail in chapter 4 of this
report. However, these changes will require congressional approval
before they can be implemented. In the interim, improvements in the
problem areas identified could make the NRP somewhat more effective.
RECOMMENDATIONS
---------------------------------------------------------- Chapter 2:4
To strengthen the NRP, the Secretary of Agriculture should direct the
Administrator of FSIS to
update the listing of compounds considered for NRP testing to
ensure that resources are not expended on inconsequential
compounds;
provide the resources necessary to complete the ranking of the
updated listing of NRP compounds within a reasonable time frame
and ensure that high-priority needs are addressed first when
plans for testing and test development are formulated for the
NRP;
modify port-of-entry residue testing for imported meat and poultry
to include residues that the domestic testing of the exporting
nation has shown to have high violation rates (such as heavy
metals), as well as the banned and unapproved compounds that the
exporting nation identifies as being used domestically, or
require that the exporting nation have programs to test
specifically for such residues prior to shipment;
strengthen the NRP methodology by ensuring that statistically valid
random sampling procedures are adhered to when meat and poultry
samples are selected for residue testing, the effects of
climatic/geographic and seasonal factors on slaughter rates and
compound use are considered for the species sampled, adequate
sample sizes are used for all of the species and compounds
tested, and the sampling rates used for each species/compound
pair are taken into account when analyzing the results.
The Secretary should also ensure that NRP data are not reported as
representative of the meat and poultry supply in general, or as
indicative of trends in the occurrence of potentially harmful
chemical residues in meat and poultry.
We also recommend that, if regulatory limits for heavy metal residues
are found to be needed, the Secretary of HHS ensure that the
Commissioner of FDA establish such limits.
AGENCY COMMENTS AND OUR
RESPONSE
---------------------------------------------------------- Chapter 2:5
USDA questioned the value of FSIS' continuing to list compounds
identified as being of concern for meat and poultry because, among
other reasons, the list is outdated. At the same time, however, FSIS
intends to apply additional resources to speed up the ranking
process. If the list is outdated, FSIS should consider updating the
list before expending further resources on ranking compounds on the
list. Accordingly, we have changed our position to recommend that
USDA update the list of compounds as a needed first step in the
process of ranking the remaining compounds in a reasonable time
frame.
In commenting on our recommendation that HHS and USDA work together
to determine the need and set standards for heavy metals, HHS took
the position that FDA was solely responsible for establishing
tolerances for heavy metal residues, if needed. We agree and have
therefore addressed our recommendation to the Secretary of HHS.
ADDITIONAL SUPPORT FROM OTHER
AGENCIES IS NEEDED TO ENHANCE THE
NRP'S EFFECTIVENESS
============================================================ Chapter 3
FSIS depends on other agencies, both outside and within USDA, to
carry out portions of the NRP. However, these agencies are not able
to meet all of FSIS' needs. For example, FSIS relies on EPA's and
FDA's assistance to identify compounds whose residues may be found in
meat and poultry and to set regulatory limits for these residues.
However, thousands of agricultural chemicals are in use worldwide;
information on them and on the residues they leave is not always
complete; and new products are continually being introduced. Also,
health and other concerns have been raised about some of the older
compounds previously approved for use by EPA and FDA, as well as
about the regulatory limits set for their residues in
foods--including meat and poultry. EPA estimates that its efforts to
reevaluate pesticide compounds will not be completed until 2006.\1
Although FDA has reevaluated some older animal drug compounds, its
efforts are hampered by resource constraints and competing agency
priorities. FSIS also must rely on FDA to take enforcement action
against violators identified through the NRP. However, other
priorities and limited resources have restricted FDA's enforcement
actions against residue violators as well. Finally, FSIS has not
fully used USDA research agencies to meet its test method development
needs for the NRP. Because of these problems, the NRP is not as
effective as it might otherwise be in preventing chemical residues
from entering the meat and poultry supply.
--------------------
\1 Pesticides: Pesticide Reregistration May Not Be Completed Until
2006 (GAO/RCED-93-94, May 21, 1993).
POTENTIALLY HAZARDOUS COMPOUNDS
MAY NOT BE IDENTIFIED
---------------------------------------------------------- Chapter 3:1
Thousands of chemical compounds are used in agricultural production
worldwide, and new chemical compounds are introduced each year.
Despite the efforts of FSIS, EPA, and FDA to identify and evaluate
the safety of compounds in use,\2 information about the universe of
chemical compounds that could contaminate the meat and poultry supply
is not complete.\3 Also, less complete information is generally
available about chemical compounds used in foreign nations that may
directly or indirectly introduce residues to meat and poultry.
The safety of previously approved compounds may also be called into
question by more recent scientific information. For instance, many
of the pesticide compounds that EPA approved in the past for domestic
food uses on the basis of older, less stringent scientific standards
have not yet been fully evaluated according to today's standards for
their potential to cause cancer, reproductive disorders, birth
defects, and environmental damage. The Congress mandated time frames
for EPA to reevaluate these older pesticides. While some progress
has been made, EPA's efforts to reevaluate and reregister these
pesticide compounds according to newer, more rigorous standards have
been hampered by resource constraints, data gaps, and the arduous
nature of the reregistration process itself. Currently, about 15,000
food-use pesticide products await reassessment and reregistration.
Meanwhile, the use of these compounds and the regulatory residue
limits established for them will continue, although knowledge of
their health and environmental effects is incomplete. EPA's primary
focus is therefore on completing the reregistration process.
Similarly, FDA officials told us that some of the animal drugs
previously approved under older scientific standards should be
reevaluated. However, since FDA does not have the resources
necessary to perform reevaluation as a separate effort, these
compounds are reevaluated when approval is sought to allow their use
on additional species or to apply them in a different manner. These
officials also stated that while some of these compounds are no
longer commonly used, others still in use have not been reevaluated.
--------------------
\2 In addition to several past and present contract arrangements with
outside data sources to develop data bases for the identification of
chemical compounds in agricultural use, EPA, FDA, and USDA personnel
meet annually as members of the Surveillance Advisory Team to
identify compounds of concern to meat and poultry. Also, the
Interagency Residue Control Group, primarily hosted by FDA and USDA,
meets monthly to discuss residues from compounds and other issues of
concern associated with food-producing animals. The Pesticide
Residue Method Group, comprising scientific/technical personnel from
EPA, FDA, and USDA, also meets periodically throughout the year to
discuss pesticide issues.
\3 Pesticides: Limited Testing Finds Few Exported Unregistered
Pesticide Violations on Imported Food (GAO/RCED-94-1, Oct. 6, 1993);
Pesticides: Status of FDA's Efforts to Improve Import Monitoring and
Enforcement (GAO/T-RCED-93-55, June 6, 1993); Food Safety:
Difficulties in Assessing Pesticide Risks and Benefits
(GAO/T-RCED-92-33, Feb. 26, 1992); Food Safety and Quality: FDA
Needs Stronger Controls Over the Approval Process for New Animal
Drugs (GAO/RCED-92-63, Jan. 17, 1992); EPA's Pesticide Import
Program, EPA, Office of Inspector General (E1E67-06-0068-81660, Aug.
16, 1988).
LIMITED ENFORCEMENT ACTIONS MAY
NOT DETER FUTURE VIOLATIONS
---------------------------------------------------------- Chapter 3:2
According to FSIS officials, the agency is limited in its ability to
ensure compliance with the program's requirements because it does not
have the authority to investigate and take enforcement action at the
farm level--responsibilities currently assigned primarily to FDA.
Under its individual enforcement testing program, FSIS can require a
producer identified as having marketed animals containing residues in
excess of established regulatory limits to bring in a sample of
animals for "preclearance" testing before the producer can sell any
more animals for food. However, FSIS cannot go to the farm and
select the animals itself to ensure that the sample is representative
of the producer's herd. In fact, FSIS frequently cannot ensure that
the sample came from the producer's herd at all.
FSIS relies on EPA\4 and FDA to investigate the causes of residue
violations. FSIS sends copies of the notification letters it sends
to violators to EPA, FDA, and state authorities--both EPA and FDA use
cooperative agreements with the states to assist them in
investigative/enforcement efforts.\5 FDA is also notified of the
violations found by FSIS through shared access to the automated
Residue Violation Information System (RVIS) data base. FDA is most
heavily involved in taking action on these referrals because FDA is
responsible for investigating how residue violations occur at the
farm level. Also, most of the residue violations found and referred
for investigation by FSIS each year are from animal drugs rather than
pesticide compounds. In 1992, only 26 EPA-related violations were
detected and reported to EPA, while 4,325 animals found to contain
residues that exceeded regulatory limits were reported to FDA for
investigation.\6
According to FDA's Compliance Program Guidance Manual, FDA is to
conduct on-farm investigations for
first-time violators when (1) the residue levels reported greatly
exceed established regulatory limits--i.e., 10 times the
established tolerance, (2) unapproved drug residues are detected
in food animals, (3) residue violations are detected in the NRP
monitoring program, and (4) violative residue levels are
detected for approved drugs that are considered to pose a high
risk to human safety;
repeat violations; and
incidents reported under the Contamination Response System.\7
An FDA compliance officer told us that, given existing resource
constraints, priorities must be set for investigation and
enforcement. Therefore, FDA first investigates repeat violators,\8
residue violations that greatly exceed established regulatory limits,
and residue violations of certain drugs that are of particular
concern. Other cases are investigated by FDA and the states if and
when resources are available.
While we do not question FDA's setting of priorities, many important
investigations may not be getting done. In a January 17, 1992,
enforcement task force report,\9 FDA itself stated that
Even though illegal tissue residues are a concern of very high
priority to the Center, we are not able to accomplish nearly as
much as we should in this program area. For example, USDA
reported illegal drug residues in 6,607 animals sampled in FY 89
and in 6,180 animals sampled in FY 90. FDA and State resources
combined were able to conduct follow-up investigations in only
1,282 and 1,125 cases respectively.
A comparison between the violations reported and investigated for
each of these 2 years indicates that FDA and the states were able to
perform follow-up investigations for fewer than 20 percent of the
residue violations reported. In responding to the task force report,
FDA's Director, Center for Veterinary Medicine, said that an increase
in resources for FDA's investigative and enforcement activities was
"desperately" needed, but the prospects for receiving these increased
resources in fiscal year 1993 were "bleak" and the prospects for
fiscal year 1994 were unimproved. As a result, FDA planned to
conduct only 826 investigations in fiscal year 1993, although FSIS
refers more than 4,000 residue-violative animals to FDA for
investigation each year.
Furthermore, FDA has limited enforcement powers. For example, FDA
cannot impose civil penalties for residue violations and, like most
other federal agencies, must refer cases warranting injunction or
criminal prosecution to the Department of Justice.\10 During this
review, FDA officials expressed concern that Justice was reluctant to
prosecute these cases. However, in commenting on the report draft,
HHS stated that "in recent years" the Department of Justice has been
supportive of FDA's residue injunction recommendations.
Table 3.1 shows the number of (1) animals with residue violations
reported to FDA from RVIS for fiscal years 1989 through 1992, (2)
repeat violators, (3) investigations initiated by FDA, and (4)
different types of regulatory actions taken. These data were
obtained from FDA's Center for Veterinary Medicine, Office of
Surveillance and Compliance.
Table 3.1
Residue Violations Reported to FDA and
Regulatory Actions Taken, Fiscal Years
1989-92
Residue violations and FY FY FY FY Tota
actions taken 1989 1990 1991 1992 l
---------------------- ------ ------ ------ ------ ----
Violative animals
reported in RVIS\a 6,607 6,180 4,327 4,325 21,4
39
Repeat violators\b 681 840 517 236 2,27
4
Investigations\c 1,283 1,240 868 1,100 4,49
1
Warning letters 85 100 102 96 383
Injunctions/consent 1 0 2 9 12
decrees
Citations 0 0 2 0 2
Prosecutions 0 0 1 0 1
------------------------------------------------------------
\a FDA generally bases investigations of violative animals on repeat
violators and violations involving high residue levels.
\b Starting in fiscal year 1991, the criteria were modified for
identifying repeat violators--resulting in a decrease in the numbers
reported.
\c Fiscal year numbers may not include some investigations because of
late reporting.
As table 3.1 shows, from fiscal years 1989 through 1992, there was
only about a 20-percent chance overall that a residue violation
referral would be investigated (4,491 investigations out of 21,439
referrals) and there was less than a 9-percent chance that a
regulatory action would follow an investigation (398 regulatory
actions out of 4,491 investigations). The data also show that if FDA
did take action, there was better than a 96-percent chance overall
that it would issue a regulatory warning letter (383 warning letters
out of 398 regulatory actions). Thus, FDA tends to rely on issuing
warning letters to residue violators. However, warning letters carry
no penalties. Consequently, chronic violators can, and do, continue
to sell contaminated animals without fear of penalty. In fact, FDA's
data show that despite 2,274 repeat violations over the 4-year
period, only 12 injunctions/consent decrees, 2 citations, and 1
prosecution were obtained against violators for the entire 4-year
period.
--------------------
\4 Although EPA investigates instances when pesticides may have been
misused, the agency has no responsibility for enforcing pesticide
tolerances. Enforcement is carried out by FSIS, FDA, and the states.
\5 Under EPA-funded cooperative agreements, the states are primarily
responsible for taking investigative/enforcement action(s) in
response to pesticide use violations. State agencies also report
special incidents involving pesticide violations to EPA's regional
offices, which in turn report them to headquarters. In addition to
state efforts, for calendar years 1989 through 1993, FSIS referred a
total of 120 residue violations to EPA.
\6 EPA's figures are on a calendar year basis, while the figures
reported to FDA are on a fiscal year basis.
\7 The Contamination Response System is designed to facilitate quick
regulatory response to residues that indicate a widespread
contamination problem may exist (i.e., accidental contamination of
livestock feed with industrial chemicals).
\8 FSIS' Guidelines for Regional Residue Officers define a repeat
violator as someone who, on one or more occasions, presents animals
for slaughter for food purposes, which contain violative tissue
residue concentrations of drugs, pesticides, or other chemical
residues, within 12 months following the issuance of a FSIS violation
notification letter. Also, a repeat violation can occur with a
closed or open case for different residue and/or slaughter class or
species, within the designated 12 months.
\9 Report of the Enforcement Task Force (Extra-Label Use), HHS, FDA,
Jan. 17, 1992.
\10 Pesticides: Adulterated Imported Foods Are Reaching U.S.
Grocery Shelves (GAO/RCED-92-205, Sept. 24, 1992).
BETTER USE OF OTHER USDA
RESEARCH AGENCIES COULD ENHANCE
TEST DEVELOPMENT FOR THE NRP
---------------------------------------------------------- Chapter 3:3
According to FSIS officials, FSIS laboratories cannot meet all of the
NRP's needs for test methods in a timely fashion because of resource
constraints and competing priorities. These officials said that FSIS
laboratories must also respond to a host of other requirements, such
as performing analyses to support FSIS' chemical and microbiological
testing programs and the certification of contract laboratories.
Although FSIS laboratories may be unable to meet the NRP's needs for
test methods, additional research and development capability exists
within USDA's Agricultural Research Service (ARS) and Cooperative
State Research Service (CSRS).\11 However, FSIS has made little use
of these additional resources to meet the NRP's needs for test
development.
According to FSIS officials, ARS assists in developing test methods
for the NRP by developing analytical methods for specific compounds
and developing new technologies and methodologies that FSIS can use
to develop multi-residue tests or apply to specific compounds.
However, for fiscal years 1989 through 1992, FSIS requested ARS to
undertake only three projects on method development--all of which
were still ongoing as of December 1993. Only one of these projects
was for the actual development of test methods and involved two
compounds. Furthermore, CSRS officials could not recall any
instances when FSIS had asked them to develop test methods.
--------------------
\11 The current administration proposes combining the CSRS, ARS, the
Extension Service, and the National Agricultural Library under the
Agricultural Research and Education Service.
AGENCY COMMENTS AND OUR
RESPONSE
---------------------------------------------------------- Chapter 3:4
In commenting on a draft of this report, HHS said that informal
activities, such as educational visits to violative producers, are
frequently more effective than taking official regulatory action.
HHS also said that, in other cases, warning letters were usually
sufficient to correct a problem and cited a decline in the number of
repeat violators as evidence to support this comment. We agree that
educational efforts can be effective in gaining compliance. However,
we do not agree that a decline in the number of repeat violators can
be used as evidence of the effectiveness of issuing warning letters.
This decline is a function of changes made in 1991 in the criteria
for identifying repeat violators that excluded middlemen with
trace-back systems from being counted as repeat violators.
HHS also commented that we were inaccurate in concluding from FDA's
data that FDA investigates only a small number of the residue
violations referred to it each year because several related
violations may be covered by one investigation. This assertion may
or may not be accurate; FDA was unable to provide data to support its
claim.
AN INTEGRATED, RISK-BASED APPROACH
TO RESIDUE PREVENTION WOULD BETTER
ENSURE FOOD SAFETY
============================================================ Chapter 4
Even if FSIS corrected the NRP deficiencies previously discussed in
this report, the program would still be faced with a fundamental
difficulty under its current approach: reliance on testing thousands
of end products at slaughter to ensure the residue safety of meat and
poultry. Federal regulatory agencies, the food industry, and the
international community have recognized that systemwide, risk-based,
preventive approaches would do more to ensure food safety and are
beginning to move in that direction. One such approach that has
gained widespread acceptance is known as the Hazard Analysis and
Critical Control Point (HACCP) system. This system employs
scientific, risk-based principles to prevent, detect, and control
various food safety hazards, including residues, throughout the
entire production process.
FSIS is currently working with industry and others to design a
risk-based HACCP system approach to ensure safer meat and poultry.
At this time, FSIS has not decided on the roles and responsibilities
for government and industry in detecting and controlling residues.
Consumer groups' concerns about food safety and industry's concerns
about additional government regulation under the new program also
have to be addressed.
CURRENT APPROACH IS
INCREASINGLY INFEASIBLE
---------------------------------------------------------- Chapter 4:1
Currently, FSIS relies heavily on the day-to-day testing of meat and
poultry products prior to retail marketing to ensure that they are
free of potentially hazardous residues. But the effectiveness of
this reactive approach is questionable, given the magnitude of the
meat and poultry supply, the hundreds of chemical compounds of
concern that need to be tested for, and the comparatively limited
number and variety of tests that FSIS can perform by itself.
Furthermore, the usefulness of this approach is likely to diminish
even more because FSIS' current resources cannot keep pace with the
industry's growth. For example, in line with federal initiatives to
control spending, FSIS' staff resources have remained relatively
constant since 1981. However, poultry production has continued to
increase at 4 percent each year and is expected to continue to do so
for at least the next several years. New chemical compounds also
continue to enter the agricultural marketplace each year, adding to
FSIS' already backlogged compound assessment, test development, and
testing needs.
RISK-BASED APPROACH IS GAINING
ACCEPTANCE
---------------------------------------------------------- Chapter 4:2
There is a growing recognition that to more effectively guard against
the potential hazards in today's food supply, inspection and testing
programs need to be (1) based on scientific risk assessments and (2)
integrated throughout the production cycle. In 1985, the National
Academy of Sciences recommended that risk-based inspection and
testing be incorporated into the meat and poultry production cycle.\1
In June 1992, GAO reported that a uniform, risk-based inspection
system was needed to ensure the safety of the food supply.\2 The
HACCP system approach, developed in the 1960s, incorporates
risk-based principles and is used by many in the meat and poultry
industry. While the HACCP system's advantages and disadvantages are
still debated, the approach is supported by the major trading
partners of the United States under the General Agreement on Tariffs
and Trade (GATT).
--------------------
\1 Meat and Poultry Inspection: The Scientific Basis of the Nation's
Program (Washington, D.C.: National Academy Press, 1985).
\2 Food Safety and Quality: Uniform, Risk-based Inspection System
Needed to Ensure Safe Food Supply (GAO/RCED-92-152, June 26, 1992).
A WIDELY ACCEPTED
SCIENTIFIC, RISK-BASED
INSPECTION SYSTEM ORIGINATED
IN THE 1960S
-------------------------------------------------------- Chapter 4:2.1
One scientific, risk-based approach to controlling microbiological,
physical, and chemical residue food safety hazards--known as the
HACCP system--has gained widespread acceptance by federal food safety
agencies, many sectors of the domestic food industry, and the
international community. The HACCP system approach evolved from
Modes of Failure concepts designed to provide "absolutely" safe food
for the 1960s manned space flight program. A major food processor
successfully used the concept to fulfill its space program contract
and subsequently adopted the HACCP system approach for use in all of
its food operations. HACCP systems have since been established by
other major food processors and retailers.
Under the HACCP system approach, producers and processors are
responsible for designing and operating risk-based quality control
systems for avoiding and/or detecting the presence of identified
hazards and for meeting the established compliance criteria set for
them throughout the production process. First, potential food safety
hazards and critical points in the production process for controlling
them are identified. Second, methods to control the identified
hazards are developed, and compliance criteria are established for
these control points. Third, the control points are then monitored
against the established criteria to ensure effective implementation.
When a control point is determined to be ineffective, the process is
stopped and corrective actions are taken. Fourth, monitoring results
and corrective actions are documented.
HACCP SYSTEM APPROACH IS
USED BY MANY IN THE MEAT AND
POULTRY SECTOR
-------------------------------------------------------- Chapter 4:2.2
Meat and poultry trade associations have recommended the HACCP system
approach and have made model HACCP plans available to their
membership. While the HACCP system approach has not been universally
adopted, voluntary programs, such as the following, are now in use
throughout substantial portions of the industry to prevent, detect,
and control chemical residues:
With the support of the National Cattlemen's Association, beef
producers have introduced the Beef Quality Assurance Program.
Originally used for residue avoidance, this program has grown to
include national producer education programs that deal with many
facets of the beef industry, including microbiological concerns.
The National Pork Producers Council reports that farmers in their
organization have voluntarily implemented HACCP programs to
avoid residue problems with their animals.
The National Turkey Federation sponsors the Chemical Residue
Avoidance Program for turkey products. This program educates
farmers about residues, including the sources of various
residues and the critical points at which they are introduced
into the production process; establishes good manufacturing
practices to avoid introducing residues during production; and
advises the industry to test its products for drug residues
before the products enter the marketplace.
The federal government has also assisted the food industry in
establishing risk-based HACCP system programs to control various food
safety threats, as in the following instances:
USDA's Animal and Plant Health Inspection Service has established
voluntary risk-based programs with egg producers in order to
control Salmonella enteritidis in egg-laying flocks.
Since 1973, FDA has regulated the production of low-acid canned
foods under a mandatory HACCP-based system. In this instance,
the HACCP system approach was successfully employed by the
canning industry to control contamination from Clostridium
botulinum, the bacterium that causes botulism. Under the
program, the industry established the risk-based quality control
and testing procedures necessary to ensure that its product is
processed according to government-approved good manufacturing
practices. FDA reviews the industry's program records and
conducts limited testing to ensure that the programs operate
effectively.
FSIS has entered into voluntary, HACCP-type joint agreements with
some individual producers in order to control recurring
antibiotic and environmental contaminant residue problems with
their animals.
Two other federal initiatives are also under way. Specifically, FDA
is establishing a mandatory, risk-based HACCP program with the
seafood industry in order to better ensure the safety and quality of
its products.\3 FSIS is currently working with the domestic meat and
poultry industry and others to design a scientific, risk-based
HACCP-type approach for use in controlling microbiological pathogens,
chemical residues, and physical hazards.
--------------------
\3 The National Marine Fisheries Service has had a voluntary HACCP
program with the seafood industry since July 29, 1992.
ADVANTAGES AND DISADVANTAGES
OF HACCP SYSTEMS ARE OFTEN
DEBATED
-------------------------------------------------------- Chapter 4:2.3
The cost-effectiveness of risk-based programs such as HACCP has often
been debated. Detailed training is required for the personnel
involved, and concerns have been voiced that this approach requires
higher staffing levels, increased recordkeeping, and higher costs.
But according to companies with pre-existing quality control systems,
the HACCP system approach does not require additional personnel
because any additional monitoring tasks can be integrated into the
existing quality control functions throughout the manufacturing
process. Furthermore, while additional training and recordkeeping
costs may be associated with the approach, the benefits that such
training and increased documentation provide also need to be
considered. Companies that have implemented HACCP programs report
that they incur fewer production problems.
The detailed documentation compiled under HACCP systems is also
available to attest to the quality and safety of a product, should
the need arise. For example, in one instance, a major food producer
with a HACCP system was able to avoid a nationwide recall of its
product because detailed program records proved to the satisfaction
of regulatory agencies that accusations of contamination were
unfounded.
Moreover, in comparison with risk-based HACCP systems that more
comprehensively attest to the residue safety of a product, the
present system of federal testing by itself may be too limited to
offset public concerns in a publicized residue incident. For
example, despite federal statements attesting to the residue safety
of its products, the apple industry incurred large marketplace losses
when consumer groups and the media publicized health concerns about
the chemical Alar and its approved use on apples. Without internal
programs to comprehensively attest to the residue safety of their
products, apple growers lost millions of dollars--whether or not the
chemical had been used on their product.\4
Similarly, federal residue testing only encompasses a small portion
of the meat and poultry supply, and despite federal efforts, chemical
residues remain a high concern for consumers.\5 Yet the welfare of
the meat and poultry industry depends upon the consuming public's
confidence in its products. One member of the 1993 World Congress on
Meat and Poultry Inspection emphasized this point:\6
I would like to emphasize here that residue control is
indispensable, not just by reason of the possible direct risk to
public health when applying undesired substances during the
fattening period, but also because of the indirect risk of
plummeting sales resulting from possible consumer boycotts.\7
Finally, the use of risk-based HACCP systems is supported by GATT, a
multilateral organization that establishes rules for international
trade. The 115 nations that subscribe to GATT--including the United
States--together account for nearly 90 percent of all world trade.
Most of the largest markets for U.S. exports--Japan, Europe, and
Canada--are moving toward risk-based HACCP inspection systems. Since
comparable food safety inspection systems are required between
trading partners, these scientific, risk-based systems may soon
become essential in order to remain competitive in international
trade.
To obtain industry views on the need for industry-led, risk-based
HACCP systems for residue prevention and control, we interviewed the
American Meat Institute's Senior Vice President for Regulatory
Affairs and Inspection Service Director, as well as the Technical
Adviser for the National Broiler Council. Together, these two
organizations represent over 80 percent of the meat and poultry
industry. In essence, the officials from these organizations
endorsed the use of risk-based HACCP system programs for residue
prevention, detection, and control from the farm to the table. They
said that much of the industry has already implemented HACCP-type
residue prevention programs without the government's assistance. In
their view, industry is much more effective at designing and
implementing HACCP programs to address residue prevention than is
government. These officials believed that the federal role under an
industry-led HACCP approach should be limited to identifying,
evaluating, and setting regulatory standards for compounds presenting
health-based concerns; developing tests; monitoring the industry's
residue prevention programs to verify the programs' effectiveness;
and conducting compliance activities. They also believed that the
government would require access to industry records in order to
effectively monitor industry programs, but they emphasized that such
access should be strictly limited to the records necessary to
evaluate the effectiveness of the residue prevention, detection, and
control programs implemented by the industry. We generally concur
with these industry views, including the need to protect proprietary
business data.
--------------------
\4 The apple industry was subsequently provided with approximately
$15 million in federal assistance to help offset the losses it
suffered from the Alar incident. Ultimately, Alar was voluntarily
removed from the market by the manufacturer.
\5 In a 1993 nationwide survey commissioned by Public Voice for Food
and Health Policy, 92 percent of the respondents expressed concern
over chemicals and pesticides used to grow food.
\6 The World Congress on Meat and Poultry Inspection was sponsored by
FSIS and hosted by Texas A&M University and met on October 10-14,
1993, at College Station, Texas. The Congress included international
regulatory officials, government and academic scientists, and
representatives of professional, trade, and consumer organizations.
\7 C.C.J.M. van der Meijs, D.V.M., Director, Veterinary Service,
Ministry of Agriculture, Nature Management and Fisheries, The Hague,
The Netherlands.
ROLES AND RESPONSIBILITIES FOR
RESIDUE DETECTION AND CONTROL
UNDER HACCP HAVE YET TO BE
DECIDED
---------------------------------------------------------- Chapter 4:3
Although FSIS has begun to move toward a mandatory risk-based HACCP
system approach for meat and poultry inspection, it is currently
unclear whether (1) HACCP programs will include requirements for
chemical residue testing and (2) the federal government or the
industry will have the primary responsibility for day-to-day residue
testing.
Concerns also exist about how the government will implement the HACCP
concept to meet its regulatory responsibilities for meat and poultry.
Government inspectors are concerned that the concept will be used to
justify reductions in personnel. Consumer groups are also concerned
about the government's implementation of the HACCP concept, but they
favor a preventive, rather than the present reactive, system of
control. Also, according to meat and poultry trade representatives,
the industry is concerned that HACCP may become yet another layer of
regulation, on top of current requirements.
These concerns might be addressed by developing a HACCP model based
on FSIS' oversight approach for testing imported meat and poultry
products. This oversight program relies on the exporting countries
to ensure that exported products meet U.S. standards. FSIS verifies
that the foreign residue programs are equivalent to the U.S. program
and performs limited residue testing at ports of entry to ensure that
the foreign programs are operating effectively. Although we believe
that FSIS needs to improve its procedure for selecting compounds to
be tested for under that program (see ch. 2), the basic approach to
residue testing under the program appears sound. Such an approach
could be adopted by FSIS for domestic meat and poultry under the
HACCP concept. However, for such an approach to work, the risk-based
HACCP concept would have to be implemented universally by the
industry, and FSIS would need access to the industry's residue
prevention, detection, and control program records in order to ensure
that the industry's actions are adequate. These requirements are
similar to the access that FDA now has to the canning industry's
records under the low-acid canned food program. FSIS may also need
more comprehensive enforcement authority in order to strengthen its
ability to ensure compliance with established residue limits,
particularly at the farm level (see ch. 3).
CONCLUSIONS
---------------------------------------------------------- Chapter 4:4
Federal resources to prevent, detect, and control chemical residues
in meat and poultry cannot keep pace with the industry's growth. At
the same time, many sectors of the industry have recognized that it
is in their own best interest to ensure the residue safety of their
products and to document that safety. A risk-based approach to food
safety appears to have widespread acceptance as the best means of
achieving these goals. Concurrently, the federal government is
moving toward a risk-based HACCP system approach for ensuring safer
meat and poultry. While many questions about implementing this
approach remain, the general structure and approach used by FSIS
under its current program to monitor chemical residues in imported
meat and poultry might be used for domestic meat and poultry as well.
MATTERS FOR CONGRESSIONAL
CONSIDERATION
---------------------------------------------------------- Chapter 4:5
To improve the prevention, detection, and control of chemical
residues in the domestic meat and poultry supply and more efficiently
use scarce regulatory resources, the Congress may wish to consider
requiring FSIS to establish scientific, risk-based HACCP systems
with the industry for residue prevention, detection, and
control;
having FSIS shift the primary responsibility for day-to-day residue
prevention, detection, and control to the industry; and
requiring FSIS to adopt a regulatory oversight role designed to
ensure the effectiveness of the industry's efforts.
As part of these deliberations, the Congress may wish to consider
whether additional authority should be provided to facilitate FSIS'
access to the industry's residue prevention, detection, and control
program records and to enhance FSIS' enforcement powers against
violators.
AGENCY COMMENTS
---------------------------------------------------------- Chapter 4:6
USDA and EPA agreed that a process-oriented, risk-based system would
be more effective than the current system in preventing residue
problems before they occur. While HHS did not specifically endorse
this point of view in its comments, FDA has previously endorsed such
a system and has recently adopted it for seafood processors under its
jurisdiction and has recently proposed that all parts of the food
industry have such systems.
COMPOUNDS INCLUDED IN THE NRP'S
MONITORING FROM 1988-92 WITH NO
RESIDUE VIOLATIONS FOR 3 OR MORE
CONSECUTIVE YEARS
=========================================================== Appendix I
Number of
consecutive years Included
in NRP monitoring in 1993
with no NRP
Ranked Ranked Not violations (1988- monitoring
Compound high\a low ranked 92) plan\b
------------------------- ------ ------ ------ ----------------- ----------
Albendazole A-2 5
Aldicarb A-4 3
Aldrin A-3 5 X
Benomyl and metabolite B-3 4
Carbadox A-3 4 X
Carbaryl B-2 5
Carbofuran and metabolite C-3 5
Carbophenothion X 5 X
Chlordane A-2 4\c X
2-chloro-1-(2, 4, 5- X 5 X
tri-chlorophenyl)
vinyl
dimethyl phosphate
(stirophos)
Cyano (3-phenoxyphenyl) D-3 3
methyl-4-chloro-a
(methylethyl)
benzeneacetate
(fenvalerate)
Cypermethrin B-3 3
Endosulfan X 4 X
Endrin A-3 5 X
Erythromycin X 4 X
Fenbendazole B-3 5\d
Flucythrinate X 3
HCB A-3 5 X
Lindane A-2 5 X
Linuron A-3 4 X
Methoxychlor D-4 5 X
Oxfendazole X 5\d
PCB A-4 5 X
Permethrin B-2 3
Phosalone X 4 X
Ronnel X 5 X
Sulfachloropyridazine X 5 X
Sulfaethoxpyridazine X 5 X
Thiabendazole B-2 5\d
Toxaphene A-2 5 X
Tylosin D-2 5 X
================================================================================
Total compounds in each 12 9 10 31 19
category
--------------------------------------------------------------------------------
\a FSIS considers compounds with CES rankings of A-1 through A-3,
B-1, B-2, and C-1 to be high priority.
\b According to FSIS criteria, compounds for which no residue
violations are found after 3 or more consecutive years of testing are
candidates for rotation out of the NRP's monitoring.
\c Three violations were found in 1992 under individual enforcement
residue testing.
\d The Benzimidazole family of compounds was removed from the 1993
monitoring plan because no residue violations were found for these
compounds in 3 to 5 consecutive years of previous testing. However,
at the insistence of FDA, FSIS plans to expend effort to rank
Cambendazole, Oxfendazole, and Febantel (another Benzimidazole) under
CES in 1993 and include the compounds in the NRP's 1994 monitoring
testing.
(See figure in printed edition.)Appendix II
COMMENTS FROM THE U.S. DEPARTMENT
OF AGRICULTURE
=========================================================== Appendix I
(See figure in printed edition.)
(See figure in printed edition.)
(See figure in printed edition.)
(See figure in printed edition.)
(See figure in printed edition.)
(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 (USDA) letter dated August 29, 1994.
GAO'S COMMENTS
--------------------------------------------------------- Appendix I:1
1. The specific animal tissues (or other animal media) that are
selected for use in residue testing are typically those identified as
being the most likely to hold the greatest concentration of the
specific residues being tested for, and/or those for which acceptable
test methods are available. Typically, animal liver, kidney, fat, or
muscle tissue is used. However, foreign nations may also test animal
feces and urine, depending on the residue involved. No matter which
test is conducted, the primary purpose of the test is to gauge, from
the results obtained, the likely level of residue present in the main
product of slaughter--the meat. Our point in the report is that
although exporting countries have been finding, through their
testing, heavy metal residues in excess of their regulatory standards
and have been reporting these results to the Food Safety Inspection
Service (FSIS), FSIS is not routinely testing the meat imported from
these nations to determine whether any health-based concerns exist.
We modified our report's language to clarify our point on this issue.
2. No change was made in response to this comment.
3. This statement was attributed to the monitoring program.
4. "Individual enforcement" was substituted for "surveillance," as
suggested.
5. USDA states in its comments that testing under the National
Residue Program (NRP) is not intended to be comprehensive and that
expending the "appallingly high" resources required for such
comprehensive testing would not be "fruitful." Nevertheless,
statements made by FSIS and other USDA officials in briefings, press
releases, and reports to the Congress have implied that this testing
is comprehensive. GAO takes the position that the program's results
cannot be used to provide an overall national estimate of all
chemicals occurring in the meat and poultry supply, partly because
the testing performed is not comprehensive. Accordingly, no change
has been made to the report in response to these comments.
6. In its comments, USDA downplays the significance of FSIS' "list
of compounds considered," stating that the list is more of a
compendium than a considered list. USDA also states that it would be
unreasonable to test for everything that could get into meat. GAO is
not suggesting that FSIS test for everything that could enter the
meat and poultry supply. However, FSIS' list of compounds
considered--or compendium--was compiled from the input of consumer
groups, industry, other regulatory agencies and from scientific
literature. While this list may require updating, it still serves as
an important starting point for assessing relative residue concerns,
identifying residues most likely to have the greatest impact on
public health, and marshalling NRP resources for testing and
developing test methods. No change has been made to the report in
response to this comment.
7. USDA states that the report overemphasizes the significance of
the 367 compounds in the "compounds considered" list. According to
USDA, there is tremendous duplication in the list; many unranked
compounds are detected by the multi-residue tests used for other
ranked compounds and therefore it would be a waste of resources to
rank them; some of the compounds listed are indistinguishable from
those naturally occurring in animals; and many of the unranked
compounds are no longer of concern for various reasons. USDA also
believes that most of the compounds on the list that are of concern
to public health have been ranked and tested. Further on, USDA
discounts the scientific credibility of some sources contributing to
the list and says that consideration has been given to eliminating
the list altogether because of its present limited usefulness.
Nevertheless, the need for an increase in resources to complete the
ranking process for listed compounds was emphasized by FSIS officials
throughout this review and in USDA's written comments on this report
as well. Furthermore, resources are currently being expended by FSIS
to rank compounds on the listing, and 21 compounds yet to be ranked
have been recommended for test method development during the 1993-98
time frame. On the basis of USDA's statements, GAO concludes that
FSIS could be expending scarce program resources on ranking and
developing tests for inconsequential compounds. Accordingly, in
addition to incorporating USDA's comments on this issue, GAO is
recommending that FSIS update its listing of compounds considered
before any additional resources are expended on compound ranking or
associated test method development.
8. The word "Branch" was changed to "Division," as suggested.
9. See comment 7.
10. See comment 7.
11. This footnote has been attributed to the monitoring program, as
suggested.
12. USDA's comments on the subsequent status of the 12 high-priority
compounds referred to as not having test methods as of the 1992 plan
have been summarized and footnoted in chapter 2 of the report. Also,
information about the NRP's test method development plans for 1993-98
is now depicted as "recommended" in response to USDA's comments.
13. This section of the report was deleted in response to USDA's
comments.
14. The section of the report describing the relationship between
multi-residue test methods and the inclusion of low-ranked compounds
in the NRP was deleted in response to comments provided by USDA.
As stated in the report, compounds are primarily selected for NRP
monitoring testing on the basis of the residues that are likely to
result from their approved uses. However, some extra-label uses are
detected when the multi-residue methods used incidentally detect
residues of compounds not approved for the animal species being
tested, or when testing for a given compound family is extended to an
unapproved species. Statements in the report were modified to
clarify this point.
USDA's comments about extra-label use and the exploratory program
essentially illustrate what is said in the report. Therefore, no
change has been made to the report in response to this comment.
15. Information on the requirements to be met by foreign nations and
on FSIS' Foreign Program Operations was brought forward in the report
in response to this comment. See also comment 1.
16. GAO does not dispute the validity of random sampling
methodology. However, unless sampling performed is truly random, the
possibility for bias does exist. Also, while GAO agrees with USDA
that the sampling performed in the monitoring program was not
designed to provide an overall national estimate of all chemical
residues occurring in the meat and poultry supply, FSIS has, in fact,
implied that the sampling can be used to do just that when the
information obtained is presented. No changes have been made to the
report in response to these comments.
In addition, while the results obtained for a specific
species/compound pair might be considered representative, without a
calculation of the sampling error the violation rate obtained might
be misinterpreted. For instance, the violation rate calculated from
a sample may imply that no residue problem exists for a specific
species/compound pair, but when the sampling error involved is
considered, there might not be enough information to really know.
This is particularly relevant to "minor" species for which the sample
size is usually small. Furthermore, GAO questions the value of
sampling compound/species pairs for minor species for which, because
of the small sample size, the probability of detecting a violation is
quite small. No changes have been made to the report in response to
these comments.
Unless the sampling design ensures that geographic areas and/or
seasons are not under/overrepresented, the differences in compounds
used across these areas, by season, may bias the results of the
sampling. For instance, if sampling for a compound predominantly
used during the summer is performed evenly throughout the year, the
level of residues for that compound could be underestimated. In
response to these comments, language was added to the report to
clarify USDA's position on seasonal adjustments.
The manner in which FSIS reports information on violations implies
that the agency is presenting an overall violation estimate.
Furthermore, although USDA states that the purpose of an overall
estimate is unclear, FSIS has, in fact, used this information to show
overall violation trends. In our opinion, the different sampling
rates used for each compound/species pair should either be weighted
properly in arriving at the estimate or the estimate should not be
reported at all. No changes have been made to the report in response
to these comments.
17. USDA's comments in this area essentially agree with GAO's
statements in the report. However, rate comparisons for
species/compound pairs should only be done if sampling errors are
taken into account. Specifically, using the example provided by
USDA, one could conclude that the 0.4-percent violation rate for sows
was about half that for market hogs. However, if sampling errors
were taken into account, any differences between these rates might be
impossible to detect. No changes to the report were necessary in
response to these comments.
18. If desired, a national estimate could be calculated, given the
current sampling design, with no appreciable additional expense, if
the sampling results were properly weighted using the sampling rates
for each species/compound pair. However, the estimate would be
representative only for the species/compound pairs that had a chance
of being sampled. The inclusion of statistical estimates and
confidence intervals would also prove useful, since most readers will
tend to interpret sampling results as universe estimates. No changes
to the report were necessary as a result of these comments.
19.USDA's comments have been addressed on the appropriate pages.
20. According to USDA, FSIS' own resources for test method
development are limited. FSIS has therefore asked the Agricultural
Research Service to assist it in meeting its test method development
needs. However, additional test method development assistance might
also be obtained from the Cooperative State Research Service, but
FSIS has not requested such assistance. No changes to the report
were required as a result of these comments.
21. USDA contends that "most" of the thousands of chemical compounds
used in agricultural production worldwide do not normally present
residue concerns for meat and poultry. However, as GAO points out,
some compounds that may present such residue concerns may not be
known because the knowledge base about them is incomplete.
Furthermore, depending on the specific scientific properties of the
compound and its ability to persist in the environment, the
insecticide "Temephos" in FSIS' example could well pose a residue
problem. For instance, in an effort to keep down undergrowth in the
orchard, food-producing animals might be allowed to graze around and
beneath the treated citrus trees. The animals would thereby consume
grasses and other vegetation that have been coincidentally sprayed or
have otherwise absorbed the insecticide, and residues of the compound
might be present in the meat of these animals. No changes were made
to the report as a result of these comments.
(See figure in printed edition.)Appendix III
COMMENTS FROM THE DEPARTMENT OF
HEALTH AND HUMAN SERVICES
=========================================================== Appendix I
(See figure in printed edition.)
(See figure in printed edition.)
(See figure in printed edition.)
(See figure in printed edition.)
The following are GAO's comments on the Department of Health and
Human Services' (HHS) letter dated August 8, 1994.
GAO'S COMMENTS
--------------------------------------------------------- Appendix I:2
1. GAO recognizes that, depending on the receptiveness of the
violative producer, informal activities such as educational visits to
violative producers (residue testing in slaughter plants is a
USDA/FSIS responsibility) may at times offer an effective alternative
to other regulatory options for ensuring future compliance with
regulations. However, the point of the discussion here is that, in
many cases, the investigation necessary to adequately make such a
determination in the first place often does not take place because of
resource constraints. Furthermore, GAO does not agree that the FSIS
residue violation data referred to FDA each year can be used to make
inferences about the effectiveness of warning letters or a decline in
the number of repeat offenders. According to FDA documents, the
criteria for identifying repeat violators were changed in 1991 and
this change resulted in a decline in the number of repeat violators.
HHS also states that "in many cases where warning letters are not
effective," an injunction may be obtained against an offender. In
addition, HHS says that injunctions have been FDA's "action of
choice," the Department of Justice has been generally supportive of
FDA's residue injunction recommendations "in recent years," and FDA
has had considerable success against repeat violators. However, data
obtained from FDA's Center for Veterinary Medicine, Office of
Surveillance and Compliance, show that from fiscal years 1989 through
1992, only 12 injunctions/consent decrees were obtained against
residue violators, despite a reported total of 2,274 repeat violators
during this same period. Also, during this review FDA personnel told
GAO that the Department of Justice required "coaxing" in order to get
it to accept residue cases for prosecution, and in the minutes of the
September 24, 1992, Interagency Residue Control Group meeting, an
attending FDA official was reported to have stated that some U.S.
attorneys and the Department of Justice are reluctant to take residue
violation cases. Therefore, while FDA's experience with Justice may
well have improved, the above data indicate that such improvement is
less than "several" years old.
HHS also maintains that GAO is "not accurate" in reporting that FDA
investigates only a small number of the residue violations that FSIS
refers to it each year. HHS says that several referrals can
frequently be covered under one investigation if the same producer is
involved and/or if the violations appear to be related to the same
causal incident. While this argument appears plausible, it conflicts
with the statements and data that FDA itself presented in its 1992
enforcement task force report. In this report, FDA states "Even
though illegal tissue residues are a concern of very high priority to
the Center, we are not able to accomplish nearly as much as we should
in this program area. For example, USDA reported illegal drug
residues in 6,607 animals sampled in fiscal year 1989 and in 6,180
animals sampled in fiscal year 1990. FDA and state resources
combined were able to conduct follow-up investigations in only 1,282
and 1,125 cases respectively." GAO based its statements on these same
data, as well as on similar information obtained for fiscal years
1991 and 1992 from FDA's Center for Veterinary Medicine, Office of
Surveillance and Compliance. In an effort to reconcile this issue,
GAO again contacted FDA's Office of Surveillance and Compliance.
However, personnel in that office were unable to provide reliable
data supporting the fact that FDA's current reporting system
substantially understates the number of residue referrals
investigated by FDA. We were told that current reporting systems do
not track information in the manner that would be required or that
could otherwise be used to estimate how much of an understatement
might be involved.
HHS' comments on FDA's investigative and enforcement activities and
GAO's position on them were summarized and incorporated into the
report. Also, since the effectiveness of FDA's enforcement
activities is currently the subject of an ongoing GAO review, HHS'
comments on FDA's investigative and enforcement activities were
forwarded for consideration during that review.
However, GAO does not agree that the report suggests that all FSIS'
residue violation referrals have an equal chance of being
investigated by FDA. In fact, FDA's statements about the impact of
resource constraints on investigative and enforcement activities, the
consequent need to set priorities for investigative/enforcement
activities, and the criteria used to set these priorities are all
presented in the report. Accordingly, no change has been made to the
report in response to these comments.
2. GAO clearly notes in the report that, according to provisions of
the Federal Food, Drug, and Cosmetic Act, FDA is responsible for
establishing regulatory safety levels for environmental contaminants
in meat and poultry. Statements in the report depicting controversy
over this responsibility and the applicability to the process of
public notice and comment rulemaking procedures emanate directly from
FDA and FSIS personnel. Furthermore, while FDA has used action
levels to regulate contaminants in certain species--i.e., mercury in
swordfish and aflatoxins in milk, grain, and peanuts--action levels
are not legally binding because they are not established through
public notice and comment procedures under the Administrative
Procedures Act (5 U.S.C. 553). The regulatory use of action levels
can therefore become cumbersome if these levels are challenged, since
in order to enforce compliance FDA must prove, in each case, that the
residue levels found would clearly be injurious to public health if
the commodity involved were consumed. Also, FDA's use of action
levels for aflatoxin was successfully challenged in court, requiring
FDA to begin the public notice and comment process in order to
establish legally binding regulatory limits. This section of the
report was revised to incorporate HHS' position on this issue, as
well as GAO's responses to HHS' comments.
HHS also attests to FDA's authority (and therefore responsibility)
for establishing heavy metal residue standards in meat and poultry.
GAO has therefore modified the report's recommendation on this issue
and addressed it solely to the Secretary of HHS.
3. This recommendation has been modified in response to HHS'
comments and has been directed to the Secretary of HHS alone (see
comment 2).
4. GAO was unable to obtain clarification from HHS on how this
comment relates to the report's matters for congressional
consideration. Therefore, no changes were made in response to this
comment.
5. FSIS has questioned the usefulness of its present listing of
compounds of concern and the importance of the compounds contained in
this listing. GAO is therefore now recommending that FSIS update the
listing before any additional program resources are used to rank
compounds and/or develop test methods for them. Hence, a detailed
breakout of the present listing of compounds would not be useful, and
no change has been made to the report.
6. This statement was modified as suggested.
7. See comment 2.
8. This statement was revised to say "FSIS must rely on FDA to take
enforcement action. . . ."
9. See comment 1.
10. References to the National Milk Producers Federation, the
American Veterinary Medical Association, and the Beef Residue
Prevention Protocol program were deleted from the report.
11. Documentation obtained from FSIS clearly shows that FSIS has
been concerned since at least October 1990 about the possible need
for a regulatory limit for lead residues in meat and poultry, and
because of these concerns, it has recently requested FDA's assistance
in determining the need for such a limit, as well as for limits for
other heavy metal residues (also see comments 2 and 3). Accordingly,
no change has been made to the report in response to these comments.
References to FDA's program for testing imported dishes for lead were
deleted from the report.
As stated in the report, with the exception of arsenic, there are no
domestic regulatory limits for heavy metals in meat and poultry, and
FSIS does not routinely test meat and poultry for heavy metal
residues. Thus, reports of such residues in meat and poultry are
likely to be "rare." Accordingly, no change was made to the report in
response to this comment.
(See figure in printed edition.)Appendix IV
COMMENTS FROM THE ENVIRONMENTAL
PROTECTION AGENCY
=========================================================== Appendix I
The following are GAO's comments on the Environmental Protection
Agency's (EPA) letter dated August 16, 1994.
GAO'S COMMENTS
--------------------------------------------------------- Appendix I:3
1. Technical comments provided by EPA under separate cover were
incorporated into the report, as appropriate.
MAJOR CONTRIBUTORS TO THIS REPORT
=========================================================== Appendix V
RESOURCES, COMMUNITY, AND
ECONOMIC DEVELOPMENT DIVISION,
WASHINGTON, D.C.
--------------------------------------------------------- Appendix V:1
Edward M. Zadjura, Assistant Director
Michael J. Rahl, Assignment Manager
Anu K. Mittal, Evaluator
Carol Herrnstadt Shulman, Reports Analyst
Sara A. Moessbauer, Statistical Analyst
CHICAGO REGIONAL OFFICE
--------------------------------------------------------- Appendix V:2
John A. Rose, Regional Manager's Representative
Jimmie Gilbert, Evaluator-in-Charge
Barbara A. Mulliken, Evaluator
Angela Pun, Evaluator
Francis M. Zbylski, Statistical Analyst