Food Safety And Standards (contaminants Toxins And Residues) Regulations 2022

[Klaudia Aricas]

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The NRP is an important component of the FSIS mission to protect the health and welfare of the consumers by regulating domestic and imported meat, poultry, and egg products and to prevent the distribution into commerce of any such products that are adulterated or misbranded.

An essential aspect of food safety in meat, poultry, and egg products is the control of residues that may result from the use of animal drugs and pesticides, or from exposure to environmental contaminants.

The NRP sampling plan guides the collection of domestic meat, poultry, and egg product samples and the import reinspection of meat, poultry, and egg products. The domestic sampling plan includes surveillance sampling, inspector-generated, and special project sampling in both federal and state-inspected slaughter facilities. The import reinspection sampling plan encompasses normal sampling, increased sampling, and intensified sampling. Details on FSIS residue sampling policy and procedures can be found in the following FSIS Directives:

Surveillance sampling is the scheduled sampling of specified slaughter subclasses [Animal Production Class Nomenclature (PDF Only)] at the time of slaughter, after a carcass has passed antemortem inspection. Carcasses are randomly selected within a given production class for sampling, with the goal of providing a nationally representative sample that can be used to determine baseline levels of chemical residues. The establishment must hold or control livestock carcasses selected for testing pending the test results. For poultry carcasses, FSIS recommends that the establishment holds the specific poultry carcasses selected for residue testing pending the test results.

FSIS inspectors conduct inspector-generated sampling when they suspect that animals may have violative levels of chemical residues. Currently, inspector-generated sampling targets individual suspect animals, suspect animal populations, and animals retained or condemned for specific pathologies.

When a necessary analytical project cannot be performed on samples that are already being collected as part of the surveillance or inspector-generated sampling, FSIS may collect special project samples. The duration of these sampling plans varies based on the situation.

Special project sampling may be specific to individual animals within a production class or may be conducted at a herd or flock level. An exploratory sampling program designed for livestock or flocks originating from the same farm or geographic region may be necessary to determine the level of exposure to one or more chemicals.

Whether an establishment must hold or control livestock carcasses subject to special project sampling depends on which chemical compounds are included in the testing and the regulatory decisions FSIS may take based on the test results.

Imported meat, poultry, and egg products are sampled through the point-of-entry Import Reinspection Sampling Plan, a chemical residue monitoring program conducted to verify the equivalence of inspection systems in exporting countries to U.S. standards. All imported products are subject to reinspection, and one or more Types of Inspection (TOI) are conducted on every lot of product before it enters the United States. The reinspection of imported products includes chemical residue testing. There are three levels of chemical residue reinspection:

The structure of the import reinspection sampling program is based on criteria used to develop the domestic plan. The estimated annual amount of product imported into the United States is used to assign the number of samples. The importer of record must maintain control of the imported product that is subject to normal and increased import reinspection sampling pending the test results. For intensified import sampling, FSIS retains the product lot pending test results.

The testing of samples collected from imported product is similar to the domestic plan, with two important exceptions. Raw product testing from samples collected at the U.S. point-of-entry is rare, because many countries ship only processed products due to restrictions based on the presence of foreign animal diseases. When the importation of raw products is allowed, the raw product typically consists of muscle tissue only. FSIS requires exporting countries to identify the animal species in each product but does not require them to identify the production class. Imported meat and poultry testing is categorized by species (e.g., poultry or porcine); egg products are distinguished as a separate category. For these reasons, the compounds selected for analysis in the import plan may not necessarily be the same as those in the U.S. domestic plan.

The range of chemical compounds evaluated for inclusion in the NRP is comprehensive in scope. Testing includes approved and unapproved veterinary drugs, pesticides, and environmental contaminants known or suspected to be present in food animals in the United States or in countries exporting products to the United States. These three broad categories of chemical residues and contaminants are described below. FSIS partners with the Food and Drug Administration (FDA) and the Environmental Protection Agency (EPA) to decide which specific chemical compounds to test for within each category.

This category includes veterinary drugs that are regulated by the FDA under the Federal Food, Drug, and Cosmetic Act (FFDCA). FDA has established tolerance levels in meat, poultry, and egg products for many veterinary drugs, which can be found in Title 21 of the Code of Federal Regulations (CFR). The current list of veterinary drugs included in the NRP, as well as the numbers and types of meat, poultry, and egg product samples tested for veterinary drugs, can be found in the List of Chemical Residues by Category / Class document.

This category includes pesticide chemicals regulated by EPA, under the FFDCA and the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). EPA has established tolerance levels for many registered pesticides, which can be found in Title 40 of the CFR. The current list of pesticides included in the NRP, as well as the numbers and types of meat, poultry, and egg product samples tested for pesticides, can be found in the Pesticide Prioritization Framework for the U.S. National Residue Program document.

This category includes any chemical compound included in the NRP that is not a veterinary drug or a pesticide chemical. The current list of contaminants included in the NRP, as well as the numbers and types of meat, poultry, and egg product samples tested for contaminants, can be found in the List of Chemical Residues by Category / Class document.

FSIS partners with the Food and Drug Administration (FDA) and the Environmental Protection Agency (EPA) as the primary Federal agencies that manage the NRP. This program requires the cooperation and collaboration of these and other agencies for its successful design and implementation.

The sampling plan design begins with a list of residues that may occur in meat, poultry, and egg products and are of concern to human health. FSIS coordinates an annual meeting of the SAT members to identify and prioritize chemical compounds of public health concern. FSIS combines this information with historical data on violation rates for each chemical compound to develop the domestic sampling and import reinspection plans. These sampling plans guide the allocation of FSIS laboratory, supply, and inspection resources.

The SAT has provided a risk-based prioritization of pesticides, as described in the Pesticide Prioritization Framework for the U.S. National Residue Program document, which informs future decisions to add additional pesticides to its analytical method. FSIS is currently evaluating an approach to identify and prioritize veterinary drugs associated with FSIS-regulated products.

For example, NRP results inform the agencies about veterinary drug and pesticide use in the food animal industry, compliance with regulations governing veterinary drug and pesticide use, and information on the presence of environmental contaminants that may affect the food supply. Residue testing data are used by the regulated establishment to make decisions about its food safety program, including its suppliers of live animals. In many cases, particularly for veterinary drugs and pesticides, the test results reported by FSIS laboratories are compared to a quantitative acceptable level (i.e., tolerance or action level) to verify that meat, poultry, and egg products tested are safe and wholesome and do not contain levels of a chemical compound that would render the product in question adulterated under the FMIA, PPIA, or EPIA.

A violation occurs when an FSIS laboratory detects a chemical compound at a level that exceeds an established tolerance or action level for that compound, or if the specific type of chemical compound detected renders the product adulterated in the absence of an established tolerance. FSIS enters information about residue violations into the Residue Violator Tracking (RVT) system, an FSIS-FDA interagency database. FSIS provides establishment and the designated FSIS inspection program personnel (IPP) with the analysis results and notifies the producer via certified letter. Under best practices, the establishment also notifies the producer that an animal from that business has been identified as having a residue violation.

In addition, FSIS shares the violation data with EPA and FDA, where the latter agency has on-farm jurisdiction. FDA and cooperating State agencies investigate producers linked to residue violations and, if conditions leading to residue violations are not corrected, can enforce legal action.

To notify the public and the industry of repeated residue violations by the same producer, FSIS posts a weekly Residue Repeat Violators List on its website that identifies producers with more than one violation on a rolling 12-month period. The list provides helpful information to the USDA AMS School Lunch Program processors and producers who are working to avoid illegal levels of residues, serves as a deterrent for violators, and enables FSIS and FDA to make better use of resources (list for processors and producers). Because FSIS updates are posted weekly, FDA may not have investigated each violation at the time of publication.

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