Presentations
How the Residue
Monitoring Program Will Change - Presented by Gary Stefan, Deputy Director (former), Animal Production Food Safety Staff,
Food Safety and Inspection Service, USDA,
Leman Swine Conference, September 21, 1998
The laws and regulatory system for ensuring food safety that serve as the underpinnings
of our food production system have been evolving since 1906. This system has served well
to protect the public from foodborne hazards and has resulted in the United States food
supply being among the safest in the world. However, maintaining the wholesomeness and
safety of the food supply requires continued vigilance and the flexibility to adapt to
changing conditions.
The prevention of unsafe levels of chemical residues in the food supply is an integral
aspect of maintaining a high level of food safety. High consumer expectations necessitate
that the United States be able to thoroughly document the safety of our meat, poultry, and
egg products. In addition, issues related to chemical residues in food may be used as
trade barriers to hinder the import and export of food products. There is evidence that
human illness such as allergic reactions, hypersensitivity, and toxicity have resulted
from drug residues in animal tissues. Similarly, violative levels of pesticide residues
are also known to have toxic effects. Expanding scientific evidence demonstrates that
antimicrobial- resistant bacteria can result from both subtherapeutic and therapeutic use
of antimicrobials in food animals and these antimicrobial-resistant bacteria are
subsequently transmitted from animals to humans. A vigilant chemical residue prevention
program, therefore, is essential to fostering the prudent use of drugs and pesticides in
animals that enter the human food supply.
Elements Of The Current Residue Monitoring Program
Under the present FSIS national residue program, Agency inspectors collect samples of
meat, poultry, and egg products at domestic slaughter establishments and egg processing
plants under FSIS and State inspection authority. These samples are then analyzed for
violative residue concentrations, either by one of three FSIS technical service
laboratories or by a laboratory under contract to FSIS. Violative residue concentrations
are determined by reference to residue limits established by the Environmental Protection
Agency for pesticides and by the Food and Drug Administration for animal drugs and
environmental contaminants. Residue samples may be collected under two separate
initiatives, monitoring and enforcement. Monitoring involves the sampling of specified
animal populations to provide information about the occurrence of residue violations on an
annual, national basis. Compounds considered usually have established residue limits, that
is, tolerances or action levels. Monitoring information is obtained through a
statistically based random selection of specimens of normal-appearing tissues from passed
carcasses. The carcass is not held after the sample is taken. Specific compounds, or
compound classes, are considered in specific slaughter classes. Each combination is known
as a compound/slaughter class pair. Generally for a specific pair, the number of specimens
chosen provides a 95 percent probability of detecting at least one violation when one
percent of the animal population is violative. The results are also used to identify
producers or other entities marketing animals with violative concentrations of residues.
When such producers subsequently offer animals for slaughter, the animals may be subjected
to enforcement testing until compliance is demonstrated. Enforcement testing consists of
the analysis of specimens collected by FSIS inspectors from suspect animals based upon
their observations of clinical signs or their knowledge of the history of the animals or
the supplier. Testing is performed to detect individual animals with violative
concentrations of residues and the number of violative residues does not reflect a
statistically valid incidence within the entire slaughter class. In-plant, rapid screening
methods are a key tool used in support of enforcement testing. It is emphasized in problem
(high prevalence) populations and used as a mechanism to prevent residues from entering
the food supply. It is also used to follow up on producers and others who have been
identified as marketing animals with violative concentrations of residues. Slaughter
classes now being sampled are horses, bulls, beef cows, dairy cows, heifers, steers, bob
veal calves, formula-fed veal calves, non-formula-fed veal calves, heavy calves, sheep,
lambs, goats, market hogs, boars, sows, young chickens, mature chickens, young turkeys,
mature turkeys, ducks, rabbits, geese, roaster pigs, and egg products. Compounds currently
sampled under the Monitoring Plan are antibiotics, chlorinated hydrocarbons and
chlorinated organophosphates, sulfonamides, arsenicals, halofuginone, carbadox, and
ivermectin. The compounds currently sampled as Special Projects are clenbuterol in
formula-fed veal calves and tranquilizers in bulls.
Why The Program Is Changing
On July 25, 1996, the sweeping reform of the U. S. Department of Agriculture regulations
known as the Final Rule on Pathogen Reduction; Hazard Analysis and Critical Control Point
(HACCP) Systems was published. The principal focus of the rule, which complements existing
food safety laws and regulations, is to reduce both the pathogenic organisms on meat and
poultry products and the incidence of foodborne illness associated with these products.
The rule also provides a new framework for the modernization of the meat and poultry
inspection system. The rule requires meat and poultry establishments to develop and
implement a system of preventive measures designed to ensure the safety of their products.
In their HACCP plans, slaughter establishments must address all chemical, physical, and
microbial hazards that are reasonably likely to occur in the animals that enter their
plants. Part 417.2 of Title 9 of the Code of Federal Regulations requires that slaughter
establishments conduct a hazard analysis to determine the food safety hazards reasonably
likely to occur before, during, and after entry into the establishment. These hazards
include chemical residues resulting from use of or exposure to animal drugs, pesticides
and environmental contaminants. If the hazard analysis identifies chemical residues as a
food safety hazard reasonably likely to occur in the production process, then the
establishment must have a critical control point to prevent, control or eliminate the
hazard. A food safety hazard that is reasonably likely to occur is one for which a prudent
establishment would establish controls because it historically has occurred, or because
there is a reasonable possibility that it will occur in the particular type of product
being processed, in the absence of those controls. FSIS expects an establishment to
consider its history of chemical residue violations and the type of livestock or poultry
it is slaughtering in determining whether drug or chemical residues are a food hazard
reasonably likely to occur. Failure to develop and implement a HACCP plan or failure to
operate in accordance with 9 CFR 417 requirements may make products produced under those
conditions adulterated.
How The Residue Program Is Changing
In December of 1997, FSIS convened an inter-agency work group comprised of representatives
from the Food and Drug Administration, Centers for Disease Control and Prevention,
Environmental Protection Agency, and several USDA agencies to evaluate the national
residue program. Their charge was to develop a comprehensive risk-based approach to
chemical residues based upon slaughter establishments assuming full responsibility for
food safety under HACCP. In May of this year, the work group presented its report, the
National Cooperative Residue Program (NCRP), to FSIS management. In developing the NCRP,
the work group accomplished several tasks. First, it conducted a reassessment of FSIS'
efforts to prevent and control violative chemical residues, it developed recommendations
on how to conduct the residue program in a HACCP environment, and it produced a document
which describes for all interested parties how the U.S. carries out it national program.
In some respects, the NCRP is not radically different from the current FSIS residue
program. It utilizes most of the mechanisms developed to support the existing tissue
residue program because they continue to be effective. Some of the procedures have been
updated, and where necessary, new procedures have been developed to address new
situations. Some significant aspects of the NCRP are summarized below.
- The identification and selection of slaughter class/compound pairs has been restructured
to include unapproved drugs and pesticides, and criteria have been established for
prioritizing compounds and compound classes based upon their potential to appear at unsafe
levels in meat and poultry. With this information, FSIS can maximize the effectiveness of
its limited resources to sample and test for those compounds most likely to be present at
violative levels. FSIS has already begun implementing the process defined in the NCRP on a
pilot basis to develop the list of priority compounds for the 1999 residue program.
- The NCRP addresses how the results of all FSIS sampling will support verification of
both individual establishment's and the entire industry's success in addressing chemical
residues. The fact that FSIS will continue to conduct a comprehensive residue program
places increased pressure on slaughter establishments to assure that products are not
adulterated with chemical residues. This is because an FSIS finding of a violative residue
can be an indication of a failure of the establishment's HACCP plan, which can lead to
enforcement action.
- An analysis of the Agency's need to verify slaughter establishments' HACCP plans for
chemical residues and to structure a national residue program based upon public health
risk determined that both efforts were complementary and compatible with the basic
structure of the current residue effort.
- The headquarters initiated monitoring efforts provide a national assessment of the
public health risks associated with specific compounds and slaughter classes.
- The range of compounds and extent of sampling FSIS is able to conduct far exceed the
capability of an individual company, thereby assuring that a more complete picture of
residue concerns is obtained.
- The inspector-initiated enforcement sampling provides the ability to target suspect
animals based upon their clinical signs or supplier/herd history. It also provides FSIS
the discretionary ability to evaluate suspect product that may not be detected by an
establishment's HACCP plan for chemical residues.
- The NCRP identifies what actions FSIS will take when we detect a residue violation in
product a slaughter establishment has permitted into commerce. Even though each violation
will be handled on an individual basis, it also provides fundamental information that will
assist both government and industry personnel in determining appropriate resolution of the
particular situation.
- The NCRP provides an overview of the requirements from a chemical residue perspective
for importing meat, poultry, and egg products into the U.S.
- The NCRP provides options which slaughter establishments and egg processing plants can
take to prevent adulteration of products from chemical residues. This information will be
particularly useful to slaughter establishments in determining what actions, if any, may
be required in their HACCP plans to address chemical residues. It also will assist FSIS
staff in determining when slaughter establishments have taken appropriate corrective
actions following detection of a residue violation by FSIS.
- Prevention and control of chemical residues are issues which generate considerable
public interest. They are also areas in which increased public participation can benefit
FSIS. The NCRP identifies mechanisms for increasing public input into the residue program.
These include holding public meetings, including residue issues on the agenda of Federal
advisory committee meetings, and participating in conferences, symposia and seminars such
as the Leman Conference.
- The NCRP re-emphasizes the inter-Agency coordination that must take place among FDA,
EPA, FSIS, other USDA agencies, and State agencies in order for a national residue program
to be effective and successful.
- The NCRP does not require significant changes to existing residue program databases,
although several minor modifications were suggested which will significantly improve the
effectiveness of these systems.
A significant change that will occur under the NCRP is that enforcement actions can be
initiated against slaughter establishments (in addition to the animal supplier) when an
FSIS sample contains violative concentrations of residues. In determining the appropriate
enforcement actions, FSIS will consider such factors as the historic pattern of
violations, the magnitude of the violation, and the extent of potential public health
risk. For those slaughter establishments subject to 9 CFR 417, when an unexpected,
unforeseen event occurs the requirements of 9 CFR 417.3(b) must be followed. Under these
requirements, if an unforeseen hazard arises, the establishment must assess its HACCP plan
to determine whether the newly identified hazard should be incorporated into the HACCP
plan. With any violative residue, the establishment must perform a review of the affected
product to determine its acceptability for distribution and take action to ensure that no
adulterated product is distributed. Repeated residue violations indicate a HACCP system
failure which could result in suspension or withdrawal of inspection.
Potential Impact Of The Proposed Changes
Responsibility for residue prevention begins with animal production. The presence in food
of chemical residues above permitted levels causes the food to be adulterated under the
Federal Food, Drug, and Cosmetic Act (FFDCA). The Food and Drug Administration regards
live animals raised for food as "food" under the
FFDCA. Everyone involved in the production, handling, transporting, or manipulating of "food animals", and the animals themselves, come
under the jurisdiction of the FFDCA. A supplier who has shipped an animal with illegal
tissue residues to slaughter has violated the FFDCA, even if the slaughter establishment
rejects the animal for processing. If a slaughter establishment has knowledge that an
animal or carcass contains violative levels of chemical residues, it should report that
information to the FSIS inspector. The inspector will collect tissue samples (a live
animal may be held until the residues deplete to the tolerance) which will be forwarded to
an FDA laboratory to support possible enforcement action against the supplier of the
animal. FSIS has identified some potential options that slaughter establishments may
consider to assist them in preventing violative chemical residues in animals they accept
for processing. Plants are not required to implement the options presented here and may
institute other options they believe to be appropriate to prevent violative residues. A
key element in determining that an animal is free of violative residues is knowledge about
its production history. The 90 days immediately before slaughter is a critical period for
most residues. Slaughter establishments need to take strong, affirmative action to ensure
that the animals they slaughter do not bear violative residues. The following procedures
are offered for consideration:
- Rejecting animals that are assessed to be at risk of having violative residues
- Clearly defining the slaughter establishment's specifications for animals suitable for
processing for human consumption. Providing this information to food animal producers and
animal suppliers will reinforce the message regarding the importance of maintaining
product safety.
- Purchasing from suppliers who have implemented proper animal drug and pesticide use
procedures including animal identification and record keeping as identified in commodity
quality assurance and good production practices programs. To convince suppliers of the
importance of preventing violative residues, periodically visit suppliers or obtain
independent third party verification that good production practices are being implemented.
- Refusing to purchase animals from suppliers who have a history of providing animals with
violative residues.
- Requiring written assurance from suppliers that all animals meet the plant's contract
specifications. Each lot or shipment of animals may need a separate assurance, depending
on the source of supply.
- Market animals from a known source may be identified by a document covering the status
of the entire lot. For feedlots and regular producer sources, a certification program
could be tied into a national quality assurance program.
- In cases of animals from order-buyers, dealers, or others, when there is a non-uniform
lot without knowledge of individual sources, documentation would be required for each
individual animal/producer lot or an affidavit that such documentation is in the
possession of the seller and available for review.
- Periodically using analytical tissue residue tests that are appropriate for the
treatment history of the animals to be slaughtered to verify that the supplier information
is correct.
- Analytical tests are a reasonable technique to verify that residue critical control
points are under control. If a slaughter establishment decides to perform analytical
testing, only reliable methods should be used. Determination of tolerances set by FDA/CVM
for animal drugs is dependent upon a specific analytical method, target compound, and
target tissue. Determinations of residues of approved animal drugs should be performed
using the methods prescribed by the FDA, or by methods that have been demonstrated to be
comparable to the FDA or FSIS method.
- EPA sets tolerances for pesticides in meat, poultry and egg products using methods that
are performance-based. Methods used to determine residues of pesticides should be FSIS
methods or must be shown to provide results comparable to FSIS methods.
- There are some cases when unapproved drugs, pesticides, or new environmental
contaminants may be detected. In such a case, sound science is the only basis for choice
of an analytical method.
Methods used by FSIS are detailed in the Analytical Chemistry Laboratory Guidebook and
the Microbiology Laboratory Guidebook published respectively by the Chemistry and
Toxicology Division and Microbiology Division within OPHS, FSIS. The criteria used by FSIS
for performance of chemical methods are outlined in the FSIS Quality Assurance Manual and
FSIS Directive 10,110.1 Rev 1. While the final rule on Pathogen Reduction and HACCP has no
direct effect on animal producers, we believe that the adoption of HACCP and food safety
performance standards within the slaughter establishments will have a ripple effect on the
food animal production industry. As plants begin to implement HACCP plans, we believe that
they will need more information on incoming animals. Exactly what information suppliers
will need to provide and how they should make it available needs to be worked out by
animal producers and the plants that receive animals. Pork producers are fortunate to have
the guidance they will need to react to any of these changes readily available to them.
The National Pork Producers Council's Pork Quality Assurance program contains
state-of-the-industry information to address food safety concerns at the production level.
Producers who implement the practices described in the program will be doing the types of
things that can provide slaughter establishments with the assurance of the safety of
incoming animals.
Future Options For Consideration
Although there is not any mandatory requirement for slaughter establishments to conduct
analytical tests on meat and poultry products, some may choose to do so. The results of
these tests could potentially be used to supplement government testing programs and help
provide a more complete picture of the safety of the U.S. food supply. Such an initiative
would require coordination and planning to ensure that the data derived would be of
acceptable quality to support claims about product safety. Potential benefits would be
increased consumer confidence in the safety of meat, poultry, and egg products, and
improved export markets.
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