Tag Archives: draft guidance

FDA

FDA’s Offers Answers on Food Facility Registration

By Food Safety Tech Staff
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FDA

FDA has released a draft guidance to help food facilities that manufacture, process, pack or hold food for consumption in the United States. Aptly titled “Questions and Answers Regarding Food Facility Registration (Seventh Edition): Draft Guidance for Industry”, the document is a 15-section Q&A addresses Food Facility Registration, of which the renewal period began on October 1 and ends December 31. The seventh edition of the guidance also adds information related to the Amendments to Registration of Food Facilities final FSMA rule.

The agency is accepting comments on the draft guidance until February 6, 2017.

FSMA

FDA Addresses Hazards Requiring Control in New Draft Guidance

By Food Safety Tech Staff
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FSMA

Today FDA released a new draft guidance related to FSMA: Draft Guidance for Industry, Describing a Hazard That Needs Control in Documents Accompanying the Food as Required by Four Rules Implementing the FDA Food Safety Modernization Act (FSMA) details the agency’s current thinking related to “disclosure statements made by an entity, in documents accompanying food, that certain hazards have not been controlled by that entity as required by certain provisions in four final rules”. These rules are the PC rules for human and animal food, the Produce rule and the Foreign Supplier Verification Program.

“This guidance provides our current thinking on how to describe the hazard under each of the four rules and which documents we consider to be “documents of the trade” for the purpose of the statements accompanying the food,” according to an FDA release.

The draft is available on the Federal Register and is open for comment 180 days after publication (October 31).

FSMA, Food Safety Tech, FDA

Draft Guidance for Qualified Facilities under FSMA PC Rules Released

By Food Safety Tech Staff
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FSMA, Food Safety Tech, FDA

Today FDA published a draft guidance to help qualified facilities in complying with the FSMA Preventive Controls (PC) for Human and Animal Food rules. Businesses that are defined as qualified facilities are subject to modified requirements of the PC rules, which can be met by submitting a form to FDA confirming that the site is implementing PCs to address hazards related to its food or is in compliance with non-Federal food safety laws and regulations.

The draft guidance, “Qualified Facility Attestation Using From FDA 3942a (for Human Food) or Form FDA 3942b (for Animal Food)” discusses how to determine whether a business meets the “qualified facility” definition and how to submit the form that demonstrates this status.

The Federal Register is scheduled to publish the document on May 16, at which point the draft guidance will be available for public comment for 180 days.

FDA Proposed Rule, Draft Guidance to Ensure Safe Imported Foods

By Food Safety Tech Staff
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The agency wants to establish a user fee program to facilitate audits.

About 15% of the U.S. food supply is imported. And within that figure nearly 80% of seafood, 50% of fresh fruit, and 20% of vegetables come from outside the United States, according to FDA. Under FSMA, the commitment to ensuring the safety of imported foods is a high priority. FDA is releasing a proposed rule, and a companion draft guidance document, to aid foreign entities in proving that they are meeting food safety import requirements.

The proposed rule, “User Fee Program to Provide for Accreditation of Third-Party Auditors/Certification Bodies to Conduct Food Safety Audits and to Issue Certifications”, is scheduled for publication Friday, July 24. FDA has named the following key groups that would be charged fees:

  • Accreditation bodies (ABs) submitting applications or renewal applications for recognition in the third-party accreditation program
  • Recognized ABs and accredited CBs that are participating in the third-party accreditation program and subject to FDA monitoring
  • Certification bodies (CBs) submitting applications or renewal applications for direct accreditation

In addition to naming those subject to the user fee, the proposed rule defines how the fees would be computed and collected, the agency’s public notification process, and what happens if those subject to the fee do not pay it (i.e., suspension of recognition).

In the draft guidance, “Third-Party Auditor/Certification Body Accreditation for Food Safety Audits: Model Accreditation Standards”, FDA makes recommendations on third-party auditor/certification body qualifications.  If finalized, the document will remain a companion guidance to the final rule.