FDA issues FSMA final rule on intentional adulteration

FDA issues FSMA final rule on intentional adulteration; animal/pet food and grain storage facilities exempt

By Jess McCluer, Vice President of Safety and Regulatory Affairs; and Randy Gordon, President

The Food and Drug Administration (FDA) on May 26 released the final version of its regulations implementing the intentional adulteration provisions of the Food Safety Modernization Act (FSMA).  Details of the FDA final rule are available online.  The final rule’s requirements will take effect 60 days after it is published in the Federal Register, which is expected to occur May 27.  But the agency provides for a lengthy implementation period of three to five years for compliance by facilities covered under the rule.

Importantly, as recommended in comments submitted in 2014 by the NGFA and NAEGA, FDA’s final rule exempts from the intentional adulteration regulations facilities that manufacture, process, pack or stor animal feed and pet food.  In addition, the final rule exempts facilities, such as grain elevators, that solely store food that may be destined for human consumption.  The exemption also expressly applies to the storage of mineral oil in liquid storage tanks and its application to raw, whole grains or oilseeds, also reflecting NGFA and NAEGA’s recommendation to FDA.

NGFA and NAEGA submitted extensive comments to FDA urging that grain handling facilities be exempt from its proposed regulation on intentional adulteration of food or feed by modifying the definition of “holding” and “manufacturing.”  In addition, the associations expressed their strong support for FDA’s proposed exemption of animal feed and pet food from the regulation.

Further, the joint statement urged FDA to also exempt liquid storage tanks used by grain-handling facilities to store mineral oil that is used as an effective means to control dust during the handling of grain. The associations said the negligible amount of oil per thousand bushels of grain that is applied is minimal, and therefore does not pose a significant risk. Rather, NGFA and NAEGA recommended that the FDA include the use of mineral oil at a grain elevator as a type of activity that would be encompassed under the definition of “holding-” – a position with which FDA agreed in the final rule. Liquid storage associated with animal food also is exempted.  But the final rule does stipulate that facilities that store and apply mineral oil on other food products, such as baked goods, condiments, spices or confectionary products, evaluate mineral oil storage and use when conducting vulnerability assessments required under the final rule.

Under the final rule, facilities that are covered are required to conduct vulnerability assessments and implement mitigation strategies to minimize or prevent identified vulnerabilities, tailored to the facility and its procedures.  Such mitigation strategies also are required to be monitored and verified, with corrective actions taken when warranted.