WASHINGTON — The Food and Drug Administration on April 17 announced it will begin routine inspections to verify compliance with the Final Rule for Mitigation Strategies to Protect Food Against Intentional Adulteration in March 2020. The announcement was made at a public meeting about the final rule held at the F.D.A.’s College Park, Md., campus.
Also on April 17, Frank Yiannas, deputy commissioner, food policy and response, notified food industry associations by letter that their request for a one-year extension of the compliance date for the rule, set for July 26, 2019, was denied.
The Food Safety Modernization Act (FSMA) final rule on intentional adulteration (I.A.) addresses hazards that may be intentionally introduced to foods, including by acts of terrorism, with the intent to cause widespread harm to public health.
Food facilities covered by the rule are required to develop and implement a food defense plan. Ryan Newkirk, senior adviser for intentional adulteration with the F.D.A.’s food defense and emergency coordination staff, explained defense plan components.
“First, facilities must conduct a vulnerability assessment, which means finding the points in their processes that pose the greatest risk for intentional adulteration,” Mr. Newkirk said. “Second, facilities must put in place mitigation, or preventive, strategies to address these vulnerabilities. Third, a system must be put in place for food defense monitoring, food defense corrective action and food defense verification, which together ensure the system is working as intended to address the vulnerabilities. Fourth is recordkeeping.”
Facility personnel working at the most vulnerable points in a facility, and their supervisors, also will be required to take food defense awareness training and undergo education and training in how to implement mitigation strategies.
The proposed Rule for Mitigation Strategies to Protect Food Against Intentional Adulteration was issued in December 2013, and the final rule was issued in May 2016.
The first compliance date for the final rule, July 26, applies to businesses with sales of $10 million or more per year and that have more than 500 full-time equivalent employees. The compliance date for small businesses, those with fewer than 500 full-time equivalent employees, is July 27, 2020. The compliance date for very small businesses is July 26, 2021. The latter businesses are exempt from the requirements of the rule with the exception that they must document that they meet the requirement to be exempt.
About 9,800 food facilities are covered by the intentional adulteration rule, the F.D.A. said. The rule also applies to facilities outside the country that meet coverage criteria and export food to the United States.
On March 12, 2019, 18 food industry associations, including the Grocery Manufacturers Association, the North American Millers’ Association and the American Bakers Association, wrote the F.D.A. to request the agency extend by one year its compliance deadline, stating that food companies do not have all the guidance and other supporting materials that the F.D.A. said it would provide and that food companies think they need in order to draft fully compliant food defense plans.
“Faced with an impending compliance date and without this critical information, our members are being forced to develop food defense plans and train employees not knowing if their efforts align with the agency’s expectations regarding compliance with this rule,” the food industry associations said. “These challenges are compounded by the fact that the I.A. rule is the first of its kind and requires significant investment beyond current industry practices. If food defense plans do not align with F.D.A.’s thinking on the subject, effective protection of the food supply will not have been advanced, and resources will have been spent unnecessarily. Simply put, we want our members to be in the best position to get this right the first time.”
Mr. Yiannas, on behalf of the F.D.A., responded, “Owing to the importance of the public health protections embodied in the I.A. rule, the availability of draft guidance and training courses on the I.A. rule, and due in part to the prolonged time period between publication of the final rule and the initial compliance date (three years), we deny your request to extend the compliance deadline.”
Mr. Yiannas continued, “As with other FSMA rules, our modus operandi as we commence I.A. rule inspections will be to ‘educate while we regulate.’ In the context of the I.A. rule, that means that our initial routine inspection activity for I.A. rule compliance will consist of straightforward ‘quick checks’ conducted during routine food safety surveillance inspections. Via the quick checks, we will verify that the facility has satisfied the basic requirements of the rule (e.g., ‘do you have a food defense plan?’). This approach is intended to serve both industry and the F.D.A. in identifying those areas of the I.A. rule that are most in need of additional educational emphasis.”
Mr. Yiannas added that the F.D.A. was “working hard” to provide additional training modules and other technical assistance materials sought by industry.