AFIA urges FDA to reduce regulatory burden

AFIA wants FDA to consider streamlining or removing several federal regulations and record-keeping requirements that are unclear, duplicative, antiquated or do nothing to enhance the safety of America’s animal food supply at the great expense of small and large animal food manufacturers.

Opportunity to provide feedback

AFIA submitted formal comments to the agency in response to its federal docket (FDA-2017-N-5104) requesting input from industry and other stakeholders on current human and animal food safety regulations and information collection requirements that could be improved upon or reduced. Upon submitting the letter to the FDA, Richard Sellers, AFIA’s senior vice president of public policy and education, said: “The American Feed Industry Association appreciates the opportunity to provide feedback to the Food and Drug Administration on several regulations impacting the animal food manufacturing industry and hopes the agency will review our comments in the spirit they are offered, mainly, as an effort to reduce the regulatory burden, both on the Center for Veterinary Medicine and regulated industry, while not compromising animal food safety.

AFIA hired several new staff during the last presidential administration just to keep up with the breadth and depth of new regulations impacting our industry and appreciates the current administration’s goal of rolling back unnecessary and burdensome regulations facing American manufacturers. As such, we hope our comments, and those of many others, are not stored somewhere and never reviewed. We believe the development of meaningful regulatory reform ideals would provide tremendous benefit in time and resources not just to the regulated industry, but also to the FDA, and urge the agency to seriously and swiftly review these comments and move toward a concerted effort to make positive changes in regulations.”

Several requests

AFIA’s letter outlines several requests for the FDA to consider in its effort to make its regulations more impactful, including:

Reducing the need for FDA inspectors to learn, and large feed mills to comply with, 2 sets of current good manufacturing practices (CGMPs), by aligning the Food Safety Modernization Act (FSMA) CGMPs with those of the medicated feed CGMPs, which have been in place for 40 years.

• More clearly defining when the FSMA written preventive controls and written supply-chain programs are or are not required to reduce the ambiguity facing animal food manufacturers and facilitate the better training of and inspections by state and federal regulators. As currently written, most facilities will assume they must follow preventive controls. These controls are estimated to cost the industry an excess of $ 800 million with very little benefit to animal food safety.
• Removing several elements of the FSMA hazard analysis (i.e., illness data, scientific reports and the assessment and determination of the probability of hazards), which would be overly cost-prohibitive for small animal food manufacturers to comply, with little indication that such egregious hazards exist.
• Establishing speedier and more consistent ingredient review processes that allow innovative products to come to market to benefit animal nutrition, animal food safety and human food safety.
• Eliminating several other unnecessary or duplicative written record-keeping requirements, including: under Part 11 Veterinary Feed Directive and medicated feed CGMPs, FSMA’s written assurances, and the FDA’s annual drug establishment registration for medicated feed mill license applications.