The Food and Drug Administration has announced that routine inspections to verify compliance with the intentional adulteration rule will begin in March 2020.
Under a May 2016 final rule, foreign and domestic food facilities that manufacture, process, pack, or hold food for human or animal consumption in the U.S. and are required to register as food facilities (with some exceptions) must prepare and implement a written food defense plan that assesses significant vulnerabilities to deliberate contamination where the intent is to cause wide-scale harm to public health. These facilities must also identify and implement strategies to minimize or prevent these vulnerabilities and establish and implement food defense monitoring procedures, corrective actions, and verification activities.
Compliance with this rule will be required as of July 26, 2019, for facilities other than small businesses and July 26, 2020, for small businesses.
However, stakeholders have said they need more time to develop fully compliant food defense plans, and the FDA says it recognizes that the intentional adulteration rule represents “new regulatory territory for all of us.” In response, while the agency is not revising the compliance dates, it has agreed to not begin routine rule inspections until March 2020. The FDA believes this approach will ensure that industry members put in place measures that protect public health while giving them time with forthcoming materials, tools, and trainings.
For more information on these and other food facility requirements, please contact Shelly Garg at (305) 894-1043.
This article was originally published in the Sandler, Travis & Rosenberg Trade Report on April 25, 2019.