April 28, 2015

TO: JPA Members

FROM: Patricia Faison

RE: JPA Regulatory Update: FDA Seeks Comments on the Food Facility Registration Proposed Rule (Input Requested by the Close of Business on May 12, 2015)

On April 10, 2015, JPA notified members that the Food and Drug Administration (FDA) had issued a proposed rule in the Federal Register (80 FR 19160; April 9, 2015) available here, to amend the Registration of Food Facilities regulation (Title 21 Code of Federal Regulations Part 1, Subpart H). The regulation requires food facilities (domestic and foreign) that manufacture, process, pack or hold food for human or animal consumption in the U.S. to register with the FDA. It was noted that the food facility registration regulation was implemented as part of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism Act). There are a number of provisions mandated by FSMA related to facility registration, and the proposed rule, once finalized, would amend the regulation. The proposed rule would add new provisions to the current regulations to codify certain provisions of FSMA that were effective upon enactment of FSMA and would also add new requirements to the regulation.

The FDA seeks input regarding a list of proposed requirements. For your convenience, attached is a document highlighting the issues raised by the Agency. The attachment is lengthy as background information is included for clarification purposes. If you believe JPA should submit comments to the FDA regarding this proposed rule, please provide your detailed input to me by the close of business on May 12, 2015. The deadline to submit comment to the FDA is June 8, 2015.

JPA’s FSMA Task Force will also be considering whether comments should be submitted to the Agency.

Patricia Faison

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