The FDA on June 20 issued the first four chapters of a nine-chapter draft guidance titled “Mitigation Strategies to Protect Food Against Intentional Adulteration” (IA Draft Guidance). The IA Draft Guidance is intended to assist industry in developing and implementing a “food defense plan” (FDP) in accordance with the “Mitigation Strategies to Protect Food Against Intentional Adulteration” Final Rule (IA Rule). The IA Rule requires domestic and foreign food facilities that are required to register under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) to address hazards that may be introduced with the intention to cause wide-scale public health harm by developing said FDP.
As described in great detail in the IA Draft Guidance, the major components of an FDP are:
- Vulnerability assessment to identify significant vulnerabilities and actionable process steps, including an explanation of why each point, step, or procedure was or was not identified as an actionable process step
- Mitigation strategies for each actionable process step and written explanations of how each mitigation strategy sufficiently minimizes or prevents the significant vulnerability associated with the actionable process step
- Food defense monitoring procedures for the implementation of the mitigation strategies, as appropriate to the nature of the mitigation strategy and its role in the facility’s food defense system
- Food defense corrective action procedures that must be taken if mitigation strategies are not properly implemented, as appropriate to the nature of the actionable process step and the nature of the mitigation strategy
- Food defense verification procedures for verification activities, as appropriate to the nature of the mitigation strategy and its role in the facility’s food defense system
The IA Draft Guidance also discusses and suggests the potential hiring of individuals known as “Food Defense Qualified Individuals” (FDQI), with knowledge and expertise of the facility’s operations as well as general food defense principles to assist in the preparation and implementation of the FDP. Finally, the Appendix to the IA Draft Guidance provides sample worksheets that businesses can use as they start developing their FDP.
FSMA Déjà vu
If the aforementioned requirements sound familiar, it is probably because there is considerable overlap between the requirements for establishing the FDP and use of FDQI pursuant to the IA Final Rule, and the requirements for establishing a written “food safety plan” (FSP) and hiring of “Preventive Controls Qualified Individuals” (PCQI) pursuant to the Final Rule for Preventive Controls for Human Food (PC Final Rule). Despite this obvious overlap, very little discussion is dedicated in the 94 pages of the IA Draft Guidance to address what could be redundant regulatory compliance activities. As a result, the issuance of the IA Draft Guidance raises the following questions:
- Are businesses going to have to develop both an FDP as well as FSP?
- Are there opportunities for synergy between the activities conducted pursuant to an FDP and those for an FSP?
- Can the role of the FDQI be filled by the PCQI?
Comments on the IA Draft Guidance close December 17, 2018. Anyone can submit their comments by clicking here (Docket No. FDA-2018-D-1398).
If you have any questions or would like assistance in drafting comments or more information on the issues discussed in this blog, please contact any of the following Morgan Lewis lawyers:
Robert G. Hibbert
 21 CFR §§ 121.126, 121.30, 121.135, 121.140, 121.145, and 121.150.
 21 CFR § 117.126. Such requirements include: hazard analysis, preventive controls, oversight and management of preventive controls, supply-chain program, recall plan, corrective action procedures, and verification procedures, as appropriate to the nature of the preventive control and its role in the facility’s food safety system.