The Food and Drug Administration published on Friday a proposed rule and a draft guidance document to support a new program under the FDA Food Safety Modernization Act (FSMA) that will help foreign entities demonstrate that imported food meets U.S. food safety requirements. The proposed rule would establish user fees for the third-party auditor accreditation program, and the draft guidance sets forth Model Accreditation Standards (MAS) for the program.
Audits and certifications for eligible foreign entities under this program will be used by importers applying for expedited review through the Voluntary Qualified Importer Program (VQIP). They may also be required by FDA as a condition of granting imported food admission into the United States when certain food safety risks have been identified.
The new documents relate to the proposed rule on third-party certification for imported foods that was issued July 29, 2013. FDA is under a court order to finalize that regulation by October 31, 2015, and comments on the proposed rule and draft guidance are due October 7, 2015.
FDA is considering several alternative approaches to assessing fees, including billing each applicant for the time FDA takes to review and evaluate the applicant’s initial or renewal application. The agency is requesting comments on this approach and asking whether it would result in higher quality submissions.
FDA would notify the public of the fee schedule annually prior to the beginning of the fiscal year in which the fees would apply. There would be no exemption or reduced fee for small businesses.
When finalized, FDA’s guidance on Model Accreditation Standards guidance will be a companion to the forthcoming final rule on third-party accreditation under FSMA. However, because the final rule has not yet been published, the draft guidance still references the requirements proposed by FDA in July 2013. Because the guidance will need to align with the final rule, IDFA expects revisions to the draft guidance after the final rule is issued.
Members may log in to read a detailed memorandum from Hogan Lovells, IDFA’s legal counsel, “FDA Proposes User Fees and Issues Model Standards for Third-Party Accreditation Under FSMA.”
Members with questions may contact John Allan, IDFA vice president of regulatory affairs and international standards, at firstname.lastname@example.org.