Base
Proposed RuleSignificant2020-201002020-09-23

Requirements for Additional Traceability Records for Certain Foods

Health and Human Services Department, Food and Drug Administration

Abstract

The Food and Drug Administration (FDA, the Agency, or we) is proposing to establish additional traceability recordkeeping requirements for persons that manufacture, process, pack, or hold foods the Agency has designated for inclusion on the Food Traceability List. The proposed rule would require these entities to establish and maintain records containing information on critical tracking events in the supply chain for these designated foods, such as growing, shipping, receiving, creating, and transforming the foods. The proposed requirements are intended to help the Agency rapidly and effectively identify recipients of foods to prevent or mitigate foodborne illness outbreaks and address credible threats of serious adverse health consequences or death resulting from foods being adulterated or misbranded. We are issuing this proposed rule in accordance with the FDA Food Safety Modernization Act (FSMA).

Action & Dates

Action
Proposed rule.
Dates
Submit either electronic or written comments on the proposed rule by January 21, 2021. Submit written comments (including recommendations) on the collection of information under the Paperwork Reduction Act of 1995 by November 23, 2020.

CFR References

Topics

CosmeticsDrugsExportsFood labelingImportsLabelingReporting and recordkeeping requirements

Public Comment

Comments Close
2021-01-21

Document Excerpt

Document Headings Document headings vary by document type but may contain the following: the agency or agencies that issued and signed a document the number of the CFR title and the number of each part the document amends, proposes to amend, or is directly related to the agency docket number / agency internal file number the RIN which identifies each regulatory action listed in the Unified Agenda of Federal Regulatory and Deregulatory Actions See the Document Drafting Handbook for more details. Department of Health and Human Services Food and Drug Administration 21 CFR Part 1 [Docket No. FDA-2014-N-0053] RIN 0910-AI44 AGENCY: Food and Drug Administration, HHS. ACTION: Proposed rule. SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is proposing to establish additional traceability recordkeeping requirements for persons that manufacture, process, pack, or hold foods the Agency has designated for inclusion on the Food Traceability List. The proposed rule would require these entities to establish and maintain records containing information on critical tracking events in the supply chain for these designated foods, such as growing, shipping, receiving, creating, and transforming the foods. The proposed requirements are intended to help the Agency rapidly and effectively identify recipients of foods to prevent or mitigate foodborne illness outbreaks and address credible threats of serious adverse health consequences or death resulting from foods being adulterated or misbranded. We are issuing this proposed rule in accordance with the FDA Food Safety Modernization Act (FSMA). DATES: Submit either electronic or written comments on the proposed rule by January 21, 2021. Submit written comments (including recommendations) on the collection of information under the Paperwork Reduction Act of 1995 by November 23, 2020. ADDRESSES: You may submit comments as follows. Please note that late, untimely filed comments will not be considered. The https://www.regulatio

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Related Documents

Other Federal Register documents from the same docket.

Full Document

Citation: 85 FR 59984