FDA to Start Inspections for Food Defense Plan Compliance in March of 2020

As part of the Food Safety Modernization Act, or FSMA, FDA's Rule Mitigation Strategies to Protect Food Against Intentional Adulteration, or IA Rule, requires facilities to write and implement a Food Defense Plan.  For facilities not considered small or very small,  the compliance date begins on July 2019.  Small facility compliance date will be the next year.  The list of exempted companies is listed below.

FDA announced this past week that it will begin to conduct compliance inspections in March of 2020.  The rule requires the facility "to develop and implement a food defense plan that identifies vulnerabilities and mitigation strategies for those vulnerabilities. These facilities will then be required to ensure that the mitigation strategies are working".

In March of this year, FDA released an updated draft guidance titled Mitigation Strategies to Protect Food Against Intentional Adulteration: Guidance for Industry.  A summary of that document is provided here.  Penn State will be conducting basic workshops on developing a Food Defense Plan.

FDA Food Safety Modernization Act (FSMA)
https://www.fda.gov/fsma
FDA Announces Intentional Adulteration Inspections to Begin March 2020
April 17, 2019
The U.S. Food and Drug Administration announced during a public meeting that routine inspections to verify compliance with the Intentional Adulteration (IA) rule will begin in March 2020.

The FSMA final rule on intentional adulteration is designed to address hazards that may be intentionally introduced to foods, including by acts of terrorism, with the intent to cause wide-spread harm to public health. Unlike the other FSMA rules that address specific foods or hazards, the IA rule requires the food industry to implement risk-reducing strategies for processes in food facilities that are significantly vulnerable to intentional adulteration.

Food facilities covered by the rule will be required to develop and implement a food defense plan that identifies vulnerabilities and mitigation strategies for those vulnerabilities. These facilities will then be required to ensure that the mitigation strategies are working. The first compliance date arrives in July 2019.

FDAhas heard from stakeholders that due to the novel nature of the IA rule and its requirements, they believe more time is needed to develop a fully compliant food defense plan. We are working hard to provide resources, including the final portion of draft guidance, which may be helpful to industry. To allow industry time with the forthcoming materials, tools, and trainings, and because the IA rule represents new regulatory territory for all of us, we will be starting routine IA rule inspections in March 2020.

Keeping the compliance dates ensures industry will put in place measures that protect public health while FDA makes additional guidance and resources available. More information about the upcoming compliance date, the recently released draft guidance, and other resources is available in an updated conversation piece featuring FDA food defense experts Ryan Newkirk and Jon Woody.

For More Information

•Protecting the Food Supply from Intentional Adulteration, Such as Acts of Terrorism
•Constituent Update: FDA Publishes Second Installment of Intentional Adulteration Draft Guidance
• Draft Guidance for Industry: Mitigation Strategies to Protect Food Against Intentional Adulteration
•FSMA Final Rule on Intentional Adulteration

FDA FSMA Summary Sheet

https://www.fda.gov/downloads/Food/GuidanceRegulation/FSMA/UCM503566.pdf

KEY REQUIREMENTS:

FSMA Final Rule for Mitigation Strategies to Protect Food Against Intentional Adulteration

EXEMPTIONS [from rule]

¢¢A very small business. While exempt, the business would be required to provide to FDA, upon request, documentation to demonstrate that the business is very small.

¢¢The holding of food, except the holding of food in liquid storage tanks

¢¢The packing, re-packing, labeling or re-labeling of food where the container that directly contacts the food remains intact

¢¢Activities that fall within the definition of “farm”

¢¢Manufacturing, processing, packing, or holding of food for animals

¢¢Alcoholic beverages under certain conditions ¢¢On-farm manufacturing, processing, packing, or

holding by a small or very small business of certain foods identified as having low-risk production

practices. The exemption applies if such activities are the only activities conducted by the business

subject to the rule. These foods include certain types of eggs, and certain types of game meats.