April 30, 2019
In a continued commitment to the agency’s modernized risk-based approach to the regulation of animal food under the FDA Food Safety Modernization Act (FSMA), the U.S. Food and Drug Administration today withdrew three outdated Compliance Policy Guides (CPGs) pertaining to the use of certain animal-derived materials in animal food.
These CPGs originally were issued in 1979-80 to explain the FDA’s enforcement priorities regarding use of certain materials in animal food. Today’s action is intended to clarify FDA regulatory policy for manufacturers of animal food (including ingredients) and to remind industry about the agency’s expectations of manufacturers who use materials from “diseased animals and animals that died otherwise than by slaughter” under the the Federal Food, Drug & Cosmetic (FD&C) Act and the FSMA preventive controls for animal food (PCAF) regulations.
The FDA has decided to withdraw CPG Sec. 675.400 – Rendered Animal Feed Ingredients and CPG Sec. 690.300 – Canned Pet Food because of the additional regulatory tools gained through FSMA. Under FSMA and the PCAF regulation, many animal food facilities are now required to establish a food safety plan, including identifying and evaluating known or reasonably foreseeable hazards. Preventive control measures must then be put into place to significantly minimize or prevent hazards requiring preventive controls.
Some examples of known hazards in ingredients from such animals are identified in Draft Guidance for Industry #245 and include biological hazards, such as Salmonella, and chemical hazards, such as decomposed tissue and residues from drugs such as pentobarbital (used for euthanasia). The FDA has recently validated a method for detection of pentobarbital in tallow. The agency has published the method on its website to make it accessible to the animal food industry and reinforce the expectation that industry must make sure its products do not contain pentobarbital. Any presence of pentobarbital renders a food product adulterated under federal law.
Additionally, the FDA has decided to withdraw CPG Sec. 690.500 – Uncooked Meat for Animal Food because it simply restates the adulteration provision of section 402(a)(5) of the FD&C Act and the FDA’s existing ability to take action on uncooked animal food products derived from “diseased animals or animals that died otherwise than by slaughter.”
For those businesses that are not subject to the preventive controls regulation, the FDA continues to use a risk-based approach to regulate animal food under the adulteration and misbranding provisions in the FD&C Act.
Although the agency has withdrawn these three CPGs, the underlying risk-based approach to food safety has not changed. As always, the FDA will take action against animal food products when necessary to protect human and animal health. Recent examples of actions the FDA has taken to protect animal and human health can be found on the FDA’s Center for Veterinary Medicine Outbreaks and Advisories page.
FSMA Final Rule for Preventive Controls for Animal Food
Draft GFI #245: Hazard Analysis and Risk-Based Preventive Controls for Food for Animals
WITHDRAWN: CPG Sec. 675.400 – Rendered Animal Feed Ingredients
WITHDRAWN: CPG Sec. 690.300 – Canned Pet Food
WITHDRAWN: CPG Sec. 690.500 - Uncooked Meat for Animal Food
FDA Response to Citizen Petition FDA-2016-P-3578
Issued by FDA Center for Veterinary Medicine.
For questions, Contact CVM.