FSIS announces standardized approach to residues without established public health tolerances
The U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced that it is standardizing the approach it will take in instances when sample results from livestock or poultry carcasses reveal chemicals for which neither the U.S. Food and Drug Administration (FDA) nor the U.S. Environmental Protection Agency (EPA) have set tolerances or regulatory levels. Such instances are rare and previously have been addressed on a case by case basis. The Agency’s new policy will better protect public health when they do occur.
“Improved testing methodology in recent years has made it possible for FSIS to collect more information about each meat or poultry sample analyzed in our labs, including the presence of compounds that we previously could not detect,” said Deputy Under Secretary Al Almanza. “The new, structured approach we are announcing today is part of FSIS’ ongoing modernization efforts to implement science-based measures that fill gaps in existing public health policy.”
FSIS administers the National Residue Program (NRP), an interagency effort that identifies, ranks and tests for chemical contaminants in meat, poultry, and egg products. FDA and EPA establish the maximum legal limits of chemicals that may be present in foodstuffs, and FSIS then administers the NRP by testing a statistical sample size of meat, poultry and processed egg products for the presence of certain chemicals and compounds.
In addition to animal drugs and pesticide chemicals, there are other chemicals that do not have established tolerances or regulatory levels and that, because of improvements in testing methodologies, are occasionally found in FSIS-regulated products. This group of chemicals includes, but is not limited to, environmental contaminants, heavy metals, industrial chemicals and mycotoxins. Unlike animal drugs or pesticide chemicals, these chemicals are usually not intentionally administered to food-producing animals, but animals are exposed to them through their presence in water, soil or the air.
Under the new approach, FSIS will derive a de minimis level (DML) for the given chemical, below which FSIS is confident that any public health concern is nonexistent or negligible. If FSIS testing finds carcasses to contain levels of a chemical above the de minimislevel, FSIS will notify the slaughter or processing establishment, as well as suppliers of the source animals, about the presence of the chemical. FSIS will also notify the FDA, EPA, or other appropriate federal partners for possible trace-back investigations and consideration of potential mitigation actions.
If FSIS begins to find chemicals above the de minimis level on a more than occasional basis, the Agency will consider conducting regular, routine sampling for that chemical and will not apply the mark of inspection to that product until test results at or under the de minimis level are received by the Agency.
FSIS has taken this approach on ad hoc basis during chemical exposure incidents and is implementing it now on a regular basis in order to better address the potential human health risks that may be associated with the presence of environmental contaminants and other potential chemical hazards without tolerances in meat and poultry products.
This change builds on other recent FSIS efforts to improve its approach to residue testing. On July 6, 2012, FSIS announced that it was restructuring the NRP with respect to how samples are collected and analyzed for chemical compounds. The new methods and procedures that FSIS has adopted have strengthened the NRP by making it into an integrated chemical hazard identification, prioritization, and management program that supports the Agency’s ability to ensure that the U.S. supply of meat, poultry, and egg products is safe to eat. FSIS has implemented new, more efficient analytical methods in its laboratories that enable the Agency to detect a greater number of chemicals than had been the case, and, at the same time, FSIS has streamlined its process for collecting samples for analysis.
FSIS requests comments on the approach discussed in this document, and on how FSIS can further improve its management of environmental contaminants and other chemical hazards in meat and poultry products. Comments may be submitted via the Federal eRulemaking Portal at: www.regulations.gov or by mail addressed to: Docket Clerk, U.S. Department of Agriculture, Food Safety and Inspection Service, Patriots Plaza 3, 1400 Independence Avenue SW, Mailstop 3782, Room 8-163A, Washington, DC 20250-3700.
The Federal Register notice can be found online at: http://www.fsis.usda.gov/wps/portal/fsis/topics/regulations/federal-register/federal-register-notices