Government shut down does not hinder FDA as inspectors are called on to inspect "high-risk" facilities.

 

FSMA Update
Jan. 16, 2019

Compliance Requirements Remain, Despite Government Shutdown
As the partial government shutdown continues, the American Feed Industry Association reminds animal food facilities that it is your responsibility to continue complying with the federal food safety regulations in the Federal Food, Drug and Cosmetic Act and specifically, the Food Safety Modernization Act.
During the shutdown, the Food and Drug Administration is limited in its activities to what is deemed "essential." Press reports and communication with officials indicate these activities are limited to issues related to human safety. In fact, inspections at foreign and domestic facilities have continued when they are deemed necessary for human safety. While the language strictly says human safety, AFIA presumes animal safety would also trigger necessary inspections and activities by the agency.
The FDA recently announced they are recalling 400 inspectors to start work without pay to conduct inspections at high-risk facilities. While directed to establish what is "high-risk" under FSMA, the agency has never finalized that work and is operating under its own factors and information to establish which human and animal food facilities will receive inspections under this provision.
While we are unable to predict if your facility will receive an inspection by state (under federal credentials) or FDA inspectors under these criteria, we remind members of their continued responsibility in complying with all applicable regulations. This reminder is offered as AFIA's crystal ball is unable to predict when the impasse over funding may end.
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:
  • 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.
The copyright law of the United States (Title 17, United States Code) governs the making of photocopies or other reproductions of copyrighted material. If you would like to photocopy, otherwise reproduce, or publish any of the foregoing material, please contact AFIA's Sarah Novak at (703) 524-0810 or Victoria Broehm at (703) 558-3579 for permission.
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