FDA has published as part of the Food Safety Modernization Act (FSMA) a final rule concerning mitigation strategies to protect food against intentional adulteration. The rule will require domestic and foreign food facilities that are required to register as food facilities under the Federal Food, Drug, and Cosmetic Act (FFDCA) to address hazards that may be introduced with the intention to cause wide scale public health harm. More specifically, under this regulation, both domestic and foreign food facilities are required to complete and maintain a written food defense plan that assesses their potential vulnerabilities to deliberate contamination where the intent is to cause wide-scale public health harm. Facilities will now 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 the vulnerable areas receive appropriate training and maintain certain records.
Potential product recall situations rank among the most stressful that a producer can face. Things move fast and decisions must be made with less-than-perfect information. While no preparation will render such situations easy or routine, a producer can reduce the stress level and help navigate this “worst-case” scenario by understanding the process and taking certain steps to prepare. The article linked below aims to familiarize producers with the recall processes and situations while suggesting areas where preparation can help.
FDA to Propose Rules to Address Foreign Supplier Verification Programs and Accreditation of Third-Party Auditors
On Monday, July 29, 2013, U.S. Food and Drug Administration (FDA) will publish two proposed regulations to implement parts of the Food Safety Modernization Act (FSMA). The proposed rules will address: (A) Foreign Supplier Verification Programs (FSVP); and (B) the accreditation of third-party auditors. The comment period for these proposed rules runs 120 days, putting the comment deadline on or about November 26, 2013.
A. FSVP: In brief, the FSVP proposed regulations would require importers to help ensure that food imported into the United States is produced in compliance with processes and procedures equivalent to those domestically under the Federal Food, Drug, and Cosmetic Act (FD&C Act). These processes and procedures include reasonably appropriate risk-based preventive controls, hazard analysis and risk-based preventive controls, and standards for produce safety. Moreover, controls should ensure the food is not adulterated or misbranded.
B. Accreditation of Third-Party Auditors: Under the accreditation rule, FDA will recognize accreditation bodies, which would in turn accredit third-party auditors to, among other things, conduct food safety audits and issue certifications for foreign facilities and food under specified programs. Importers will not generally be required to obtain certifications, but in certain circumstances FDA may use certifications from accredited auditors in determining whether to admit certain imported food into the United States that FDA has determined poses a food safety risk. FDA may also use accreditation to determine whether an importer is eligible to participate in a voluntary program now under development for expedited review and entry of food.
These two new proposed rules are part of several FDA initiatives to implement the FSMA. Previously, FDA published proposed rules for produce safety and preventative controls for human food. The comment period for those two proposed rules ends on September 16, 2013.
In addition, FDA has three other regulations to propose in connection with FSMA: (1) preventative controls for animal feed; (2) protection against intentional adulteration; and (3) sanitary transportation of food.
By Court order, all of FDA’s FSMA rules must be proposed by November, 30, 2013, the comment period must end by March 31, 2014, and FDA must publish all final regulations no later than June 30, 2015.