On May 26, 2016, the U.S. Food and Drug Administration (FDA) published the final rule on “Focused Mitigation Strategies to Protect Food Against Intentional Adulteration
.” This final regulation requires is aimed at preventing intentional adulteration from acts intended to cause wide-scale harm to public health, including acts of terrorism targeting the food supply. Rather than targeting specific foods or hazards, this rule requires mitigation (risk-reducing) strategies for processes in certain registered food facilities.
The final rule targets larger food businesses (>$10 million total food sales), with vulnerable activities, to have a written food defense plan and develop and implement focused mitigation strategies to address vulnerabilities to deliberate contamination of the food supply. While the probability of intentional adulteration of the food supply to cause public health harm is low, the potential impact of such adulteration may be catastrophic and therefore warrants that firms with significant intentional adulteration vulnerabilities take appropriate steps to deter, detect or prevent intentional food adulteration. Acts of intentional adulteration may take on many forms including those where the intention is to cause large-scale public health harm; acts of disgruntled employees, consumers, or competitors; and economically motivated adulteration.
It’s anticipated the agency will soon be issuing important companion guidance documents for all final FSMA rules that will provide more detailed information about coverage and compliance requirements. There will be an opportunity to provide comments on these upcoming draft guidance documents, so stay tuned.
Who is covered?
- This rule applies to both domestic and foreign companies that are required to register with the FDA as food facilities under the Federal Food, Drug, and Cosmetic (FD&C) Act.
- This rule is designed to primarily cover large companies whose products reach many people, exempting smaller companies. There are 3,400 covered firms that operate 9,800 food facilities.
- It does not cover farms.
- A very small business. While exempt, the business would be required to provide to FDA, upon request, documentation to demonstrate that the business is very small.
- The holding of food, except the holding of food in liquid storage tanks
- The packing, re-packing, labeling or re-labeling of food where the container that directly contacts the food remains intact
- Activities that fall within the definition of “farm”
- Manufacturing, processing, packing, or holding of food for animals
- Alcoholic beverages under certain conditions
- On-farm manufacturing, processing, packing, or holding by a small or very small business of certain foods identified as having low-risk production practices. The exemption applies if such activities are the only activities conducted by the business subject to the rule. These foods include certain types of eggs, and certain types of game meats.
FSMA Final Rule Webinars
PMA hosted a webinar series with allied associations, featuring the FDA.