FDA Releases Supplemental Draft Guidance on Food Defense Regulation

FDA released a supplemental 'draft' guidance to support the IA Rule (Intentional Adulteration or Food Defense).  It is supplemental in that it adds content on elements not covered in the previous guidance issued last year (Draft Guidance for Industry: Mitigation Strategies to Protect Food Against Intentional Adulteration March 2019).

This supplemental guidance covers the elements for managing mitigation strategies - specifically corrective action, verification, and reanalysis.  It provides more detail on what FDA would be looking for when evaluating the mitigation strategies the facility has chosen.

As you know, the facility conducts a vulnerability assessment to determine which points in the process are most vulnerable, the actionable process steps.  For the actionable process steps, the facility must determine and implement mitigation strategies to reduce the vulnerability.  These strategies must be monitored, documented, verified, have corrective action, and be reanalyzed.

In general, the guidance allows a more basic and flexible approach than Preventive Controls regarding corrective action and verification activities. For example, if a mitigation strategy is having a tank hatch locked with a monitoring activity stated as checking the lock. The corrective action if a tank is not locked would be to lock it and retrain the employee.  Verification is simply checking records to make sure the lock check was taking place, and the corrective action of retraining the employee took place.  And of course, conducting analysis of the plan every 3 years (unless there is a process change or other special conditions).


https://www.fda.gov/regulatory-information/search-fda-guidance-documents/supplemental-draft-guidance-industry-mitigation-strategies-protect-food-against-intentional
GUIDANCE DOCUMENT
Supplemental Draft Guidance for Industry: Mitigation Strategies to Protect Food Against Intentional Adulteration 


February 2020
Docket Number:
FDA-2018-D-1398
Issued by:
Office of Foods and Veterinary Medicine, Center for Food Safety and Applied Nutrition
The FDA Food Safety Modernization Act (FSMA) added to the Federal Food, Drug, and Cosmetic Act (FD&C Act) several new sections that reference intentional adulteration.  For example, section 418 of the FD&C Act (21 U.S.C. 350g) addresses intentional adulteration in the context of facilities that manufacture, process, pack, or hold food, and that are required to register under section 415 (21 U.S.C. 350d).  Section 420 of the FD&C Act (21 U.S.C. 350i) addresses intentional adulteration in the context of high-risk foods and exempts farms except for farms that produce milk [1].
We implemented these intentional adulteration provisions through a rule entitled “Mitigation Strategies to Protect Food Against Intentional Adulteration” (IA rule).We published the final rule in the Federal Register of May 27, 2016.  (81 FR 34166).
This supplemental draft guidance adds to the draft guidance previously published in March 2019 with chapters covering topics focusing on food defense corrective actions, food defense verification, reanalysis, and recordkeeping. It also includes appendices on FDA’s mitigation strategies database and how businesses can determine Small and Very Small Businesses status under the IA rule.

[1] The IA rule did not include any requirements for farms that produce milk. As such, farms that produce milk are not covered under this draft guidance.