FDA has published its last major regulation implementing the
Food Safety and Modernization Act ("FSMA"): a final rule on mitigation strategies to protect
food against intentional adulteration. This rule 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. Under the new rule, both domestic and
foreign food facilities, for the first time, are required to
complete and maintain a risk-reducing written food defense plan
that assesses potential vulnerabilities and mitigation strategies,
establish food defense monitoring procedures and corrective
actions, verify the system is working, and ensure personnel
assigned to the vulnerable areas receive appropriate training and
maintain certain records. The final rule requires companies to
perform a vulnerability assessment based on the evaluation of: (i)
the severity and scale of the potential public health impact; (ii)
the degree of physical access to the product; and (iii) the ability
to successfully contaminate the product, which represents a change
as compared to the proposed rule. In addition, the final rule
extends the list of exempt facilities. It also give those companies
subject to the rule more time to comply. For instance, most
companies have three years to comply with the new rule, small
companies (500 employees or less) have four years, and very small
companies (sales of less than $10 million per year during three
consecutive years) must comply in five.
FDA has published a summary of the final rule covering key
requirements and a diagram intended to assist companies in
understanding whether the new rule applies to them. Additionally,
FDA will host a webinar on the topic on June 21, 2016.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.
