Food Defense FDA issues final rule on intentional adulteration of food
With the issuance of this rule, the FDA has finalized all seven major rules implementing the core of the FDA Food Safety Modernization Act (FSMA).
Under the new rule, both domestic and foreign food facilities, for the first time, will be required to complete and maintain a written food defense plan that assesses their potential vulnerabilities to deliberate contamination. Facilities will have to identify and implement mitigation strategies to address these vulnerabilities, establish food defense monitoring procedures and corrective actions, verify that the system is working, ensure that personnel assigned to these areas receive appropriate training and maintain certain records.
The rule was proposed in December 2013. The final version took into consideration more than 200 comments submitted by the food industry, government regulatory partners, consumer advocates and others.
Food manufacturers will be required to comply with the new rule within three to five years after its publication, depending on the size of the business. Businesses that are not small or very small and do not qualify for exemptions would have to comply no later than three years after the publication of the final rule. Small businesses, those employing fewer than 500 persons, would have four years to comply.
The rule does not apply to very small businesses, those averaging less than $10 mill. per year, except that such facilities would be required to provide for official review, on request, documentation to show that they qualify for this exemption. They will have to comply with these modified requirements within five years.