NEXT WEEK: FSMA Compliance Dates

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Courtesy of AFIA

Monday, Sept. 17, marks the next compliance date for the Food Safety Modernization Act’s animal food rule, with requirements set for both very small and small businesses.

On this date, very small businesses (those with less than $2.5 million in animal food sales or value) will need to be in compliance with the “Current Good Manufacturing Practice, Hazard Analysis and Risk-based Preventive Controls for Food for Animals” subpart B (the current good manufacturing practices) and related requirements. Small businesses (those with fewer than 500 employees across the entire business) will need to comply with nearly every other part of the regulation, including subpart C on hazard analysis and risk-based preventive controls and the completion of their facility’s animal food safety plan. Sept. 17 also marks the final phase-in granted by the Food and Drug Administration for the regulation, with all-sized facilities now complying with at least one of the regulation’s components.

In August, the FDA announced that routine preventive controls inspections will not begin until the fall of 2019 for small businesses. While the agency will delay its inspections, compliance is still required. Facilities must still have a written animal food safety plan, including a hazard analysis, and have it in operation by next week. The FDA reserves the right to take regulatory action if an animal food safety event occurs at a facility during this time, even amid delayed inspections.

Large businesses (those with more than 500 employees across the entire business) have already been in compliance with CGMPs and the hazard analysis and risk-based preventive controls since 2016 and 2017, respectively. These facilities should expect preventive controls inspections to start in October and for FDA to pair these new inspections with another CGMP inspection. This means inspectors will likely be in the facility for several days at a time.

We anticipate that very small businesses may also start receiving CGMP inspections at their facilities starting in October, when the new federal fiscal year begins.

Please see the American Feed Industry Association’s FSMA webpage for a list of all of the resources available to AFIA members to ensure your facility is in compliance with these and other FSMA regulations.

Contact AFIA

Visit the FDA’s FSMA webpage for the latest FSMA news and to sign up for email updates. For questions on any aspect of FSMA, please contact the AFIA staff:

  • Richard Sellers, senior vice president of public policy and education, (703) 558-3569
  • Leah Wilkinson, vice president of public policy and education, (703) 558-3560
  • Gina Tumbarello, director of international policy and trade, (703) 558-3561
  • Gary Huddleston, director of feed manufacturing and regulatory affairs, (703) 666-8854
  • Paul Davis, Ph.D., director of quality, animal food safety and education, (703) 650-0146
  • Louise Calderwood, director of regulatory affairs, (703) 558-3568

Signed into law Jan. 4, 2011, FSMA provides the Food and Drug Administration with sweeping new authorities and requirements for the animal food industry. The food and feed industries originally supported the bipartisan law, which, among other provisions, authorized the FDA to: promulgate new rules for preventive controls, develop performance standards, create new administrative detention rules, recall adulterated products and hire more than 4,000 new field staff. It is estimated that if fully implemented, the law will cost the U.S. feed and pet food industries more than $1 billion with little improvement to animal health, animal food safety or other real benefit. It is unclear whether Congress will provide sufficient funding authorization to fully implement the law.

Although the FDA has announced that the agency would not inspect facilities with more than 500 employees for hazard analysis and preventive controls compliance until late 2018, AFIA believes facilities must be in compliance with FSMA rules applicable to the firms’ sizes. For more information on required compliance dates, visit FDA’s website. Moreover, AFIA has urged the FDA to reopen the comment period to the animal food final rule and extend compliance dates, so that comments can be taken on the inapplicability of certain parts of the final rule to the feed industry.