Draft Guidance for Industry: Describing a Hazard That Needs Control in Documents Accompanying the Food, as Required by Four Rules Implementing FSMA October 2016
Not for implementation. Contains non-binding recommendations.
- Docket Number:
- Issued by:
Guidance Issuing OfficeCenter for Veterinary MedicineCenter for Food Safety and Applied NutritionOffice of the Commissioner, Office of Policy, Legislation, and International Affairs, Office of Policy
This guidance concerns four of the seven foundational rules that we have established in Title 21 of the Code of Federal Regulations (21 CFR) as part of our implementation of the FDA Food Safety Modernization Act (FSMA; Pub. L. 111–353).
- Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food
- Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals
- Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption
- Foreign Supplier Verification Programs (FSVP) for Importers of Food for Humans and Animals
This guidance is intended for any entity that is subject to certain provisions (in part 117, part 507, the produce safety regulation, or the FSVP regulation) that require a disclosure statement, in documents accompanying food, that certain hazards have not been controlled by that entity. This guidance is not intended to address other requirements of part 117, part 507, the produce safety regulation, or the FSVP regulation.
FDA's guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe our current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in FDA guidances means that something is suggested or recommended, but not required.
This draft guidance, when finalized, will represent the current thinking of the Food and Drug Administration (FDA or we) on this topic. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. To discuss an alternative approach, contact FDA’s Technical Assistance Network by submitting a form.
You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))
If unable to submit comments online, please mail written comments to:
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All written comments should be identified with this document's docket number: FDA-2016-D-2841.