The Food and Drug Administration (FDA) has published notice of a 90-day extension, until June 30, 2014, of the comment period on its proposed rule addressing intentional adulteration of food and on an associated draft document, both published in the Federal Register on December 24, 2013 (see blog postings dated January 7, January 31, and February 21, 2014). 79 Fed. Reg. 16,251 (Mar. 25, 2014).
Under FDA’s proposed rule, entitled “Focused Mitigation Strategies to Protect Food Against Intentional Adulteration,” a food facility would be required to have a written food defense plan that addresses significant vulnerabilities in its food production process, and then would need to identify and implement strategies to address these vulnerabilities, establish monitoring procedures and corrective actions, verify that the system is working, ensure that personnel assigned to the vulnerable areas receive appropriate training, and maintain certain records. The proposed rule does not apply to farms and food for animals.
The comment period on the proposed rule, and an associated draft document entitled “Appendix 4 to Draft Qualitative Risk Assessment of Risk of Activity/Food Combinations for Activities (Outside the Farm Definition),” was extended in response to requests that conveyed concern that the original 100-day comment period did not allow time to thoroughly analyze the proposal, due to its inherent complexity and the unique nature of food defense issues.
