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Updated: FDA Releases Draft Guidance for Food Facilities Required to Protect Against Intentional Adulteration
Practical Law Legal Update w-002-5257 (Approx. 5 pages)
Updated: FDA Releases Draft Guidance for Food Facilities Required to Protect Against Intentional Adulteration
by Practical Law Commercial Transactions
| Published on 03 Jul 2018 • USA (National/Federal) |
On June 20, 2018, the Food and Drug Administration (FDA) released draft guidance for companies obligated to comply with the FDA's final rule published on May 27, 2016, which requires domestic and foreign food facilities to address vulnerabilities to intentional adulteration that could cause wide scale public health harm.
This resource was updated on July 3, 2018 to account for the Food and Drug Administration's (FDA) issuance of a draft of the first of three guidance documents for companies required to comply with the FDA's final rule regarding protection from intentional adulteration of food, published on May 27, 2016 (see Update).
On May 27, 2016, the Food and Drug Administration (FDA) published a final rule requiring food facilities to conduct assessments for vulnerabilities to intentional adulteration, and to take steps to mitigate the identified vulnerabilities (Mitigation Strategies to Protect Food Against Intentional Adulteration, 81 Fed. Reg. 34166-01 (May 27, 2016)). The FDA issued this rule under the Food Safety Modernization Act of 2011 (FSMA). It applies to facilities required to register under the Federal Food Drug and Cosmetic Act (FD&C).
Assessment and Mitigation Requirements
Under the final rule, owners, operators, and agents in charge of food facilities are required to protect against intentional adulteration of food by:
- Preparing and implementing a written food defense plan that includes:
- a vulnerability assessment to identify significant vulnerabilities; and
- identifies actions, strategies, and procedures for food defense monitoring, corrective actions, and verification.
- Conducting a vulnerability assessment for each type of food manufactured, processed, packed, or held at the facility using appropriate methods.
Using this vulnerability assessment, food facilities then must establish and implement:
- Mitigation strategies at each process step to minimize or prevent vulnerabilities, and provide a written explanation of how the strategy accomplishes its goal.
- Management components of the mitigation strategy to ensure proper implementation.
- Corrective action procedures if the mitigation strategies are not properly implemented.
- Specified food defense verification activities, as appropriate to the nature of the mitigation strategy and its role in the facility's food defense system.
To ensure these strategies function properly, food facilities are also required to:
- Conduct a reanalysis of the food defense plan as a whole at least once every three years, or whenever circumstances (including changes to the facility, new information, or emerging vulnerabilities) demand it.
- Ensure that all individuals who perform required food defense activities are qualified to perform their assigned duties.
Exempted Facilities and Activities
The following facilities and activities are exempted from the new requirements:
- Very small businesses (i.e. a business averaging less than $10 million in both sales of human food plus the market value of human food manufactured, processed, packed, or held without sale), except to provide documentation sufficient to show the facility qualifies for this exemption.
- Holding of food, except the holding of food in liquid storage tanks.
- Packing, re-packing, labeling, or re-labeling of food where the container that directly contains the food remains intact.
- Farms subject to section 419 of the FD&C (21 U.S.C.A. § 350h).
- Alcoholic beverages at a facility that meets certain conditions.
- Manufacturing, processing, packing, or holding of food for animals.
- On-farm manufacturing, processing, packing, or holding by a small or very small business of certain foods identified as having low-risk production practices, if such activities are the only activities conducted by the business.
Compliance Deadlines
This rule is effective July 26, 2016, but facilities have longer to comply, based on their size:
- Facilities that are not considered "small" or "very small" have until July 26, 2019 to comply.
- Small businesses (i.e. those employing fewer than 500 full-time equivalent employees) have until July 26, 2020 to comply.
- Very small businesses (i.e. a business averaging less than $10 million in both sales of human food plus the market value of human food manufactured, processed, packed, or held without sale) have until July 26, 2021 to provide documentation sufficient to show they are exempt from the rule.
For more general information on FDA regulations for the production and distribution of food products, see Practice Note, FDA Food and Dietary Supplement Regulations and FDA Food and Dietary Supplement Regulations Checklist.
Update
On June 20, 2018, the FDA released draft guidance for companies required to comply with 81 Fed. Reg. 34166-01 above. The guidance's purpose is to help develop and implement a food defense plan (FDP). The document provides guidance on the following items:
- Understanding the importance of each FDP component.
- How to conduct a vulnerability assessment to identify vulnerabilities and actionable process steps.
- How to identify and implement mitigation strategies for actionable process steps.
- How to identify and apply mitigation strategy management components.
- Understanding FDP reanalysis requirements.
- Understanding individual education, training, and experience needed to perform activities.
- Understanding FDP recordkeeping requirements.
This is the first of three planned guidance documents. The FDA is accepting electronic and written comments on its draft guidance until December 17, 2018.