The FDA made the historic announcement yesterday that they are withdrawing three of their most loathsome Compliance Policy Guides (CPGs), including the ones that allowed pet food manufacturers to use diseased animal tissue in pet food and animal feed with impunity for decades.
The agency is pulling the plug on the three policies which allowed for 4D (dead, dying, diseased and disabled) animal tissue in pet food and animal feed, specifically CPG 675.400 (“Rendered Animal Feed Ingredients”), CPG 690.300 (“Canned Pet Food”) and CPG 690.500 (“Uncooked Meat for Animal Food”)
The FDA says the reason for their withdrawal of the policies was that they were “outdated,” adding, they were in violation of part 507 of the Food Safety Modernization Act (FSMA) and were in violation of the adulteration provision of section 402(a)(5) of the Federal Food Drug and Cosmetic (FD&C) Acts.
The FDA put the animal feed, pet food, and rendering industries on notice, telling them that it is the agency’s “expectation” that if the industries use materials from “diseased animals and animals that died otherwise than by slaughter” they would be considered illegal under the FD&C Act and the FSMA preventive controls for animal food regulations.
Yesterday’s announcement came as a surprise, in sharp contrast to the agency’s staunch defense of the compliance policies. Since the inception of the policies, the FDA reasoned that the use of adulterated material – namely 4D meat – was acceptable because of the long history of safe use of the products in animal food. They explained, that when the compliance policies were originally released, the agency had no evidence of a disease or other illness resulting from rendered or canned ingredients, despite the use of tissues from diseased animals.
While the news that the FDA withdrew the compliance policies appeared to be a significant step forward, a darker truth emerged in a document replying to a citizen petition released along with yesterdays announcement. In reply to the petition, the agency wrote to the petitioner that “we do not believe that the use of diseased animals or animals that have died otherwise than by slaughter to make animal food poses a safety concern and we intend to use enforcement discretion where appropriate.”
But one of the problems with this belief system is how to address the nagging problem of pentobarbital popping up in pet food – the drug that’s used to euthanize companion animals such as cats, dogs, and horses. To help stem the flow of euthanized animals in pet food, and to identify pentobarbital contamination, the agency also announced they had validated a method for detection of pentobarbital in tallow. The agency published the method on its website to make it accessible to the animal food industry and to “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.”
Until now, there never has been a validated method for testing for the drug in animal fat, and renderers accepted dead animals whether they had been euthanized or not because there was no practical method of identifying euthanized animals from animals that had died from some other cause. The validation is an important step which provides instruction on the routine quantitative determination of pentobarbital in tallow.
It’s difficult to say how much impact yesterday’s announcements will have – if any – on the pet food industry or if it can repair the damage caused by a government that allowed diseased animals in pet food for decades. But for the pet parents whose animals suffered from the consequences of the FDA policies, their trust in a system that allowed 4D tissue in pet food is unlikely ever to be restored.
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
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