FDA to Hold Meeting on Food Safety Act's "New Paradigm" for Importers
The Food and Drug Administration will be holding a public meeting on March 29, 2011 on the implementation of the import safety provisions of the recently enacted FDA Food Safety Modernization Act (FSMA), called "a New Paradigm for Importers." Topics to be covered will include importer verification, the Voluntary Qualified Importer Program, import certifications for food, and third-party accreditation.
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Registration to attend the March 29 public meeting is due by March 22, 2011, and should be emailed here.
(See ITT’s Online Archives or 03/11/11 news, 11031125, for second FDA notice on a public hearing on March 30 and 31, 2011, to provide stakeholders the opportunity to discuss FDA’s use of international comparability assessments to enhance the safety of imported foods and animal, as well as FDA’s efforts to gather information from regulators in other countries.)
Meeting Will Cover FSMA’s Major Issues Affecting Importers
FDA states that the FSMA (Public Law 111-353) requires FDA to develop regulations, guidance, and to otherwise implement the following major import-related provisions, which will be the subject of discussion at the March 29 meeting:
Foreign Supplier Verification Program (FSVP). The FSVP requires importers to conduct risk-based foreign supplier verification activities to verify that imported food is not adulterated under section 402 of the FD&C Act (21 USC 342) or misbranded under section 403(w) of the FD&C Act (21 U.S.C. 343(w)) (relating to allergens) and is produced in compliance with FDA’s preventive controls requirements and produce safety standards, where applicable.
Facilities in compliance with FDA's seafood, juice, or low-acid canned food products requirements are exempted in whole or in part from the FSVP requirements.
The statute also directs FDA to exempt, by notice in the Federal Register, importers of food imported into the U.S. in small quantities for research uses or for personal consumption.
The statute further directs FDA to issue implementing regulations and guidance on FSVPs.
Voluntary qualified importer program (VQIP). The VQIP requires FDA to establish a voluntary, user-fee funded program to expedite entry into the U.S. of imported food from eligible, qualified importers. To be eligible to participate in VQIP, an importer must offer food for importation from a facility that has a certification by an accredited third party. FDA will qualify eligible importers to participate in VQIP based on risk considerations.
The statute directs FDA to issue guidance on participation in and compliance with VQIP.
Importer certifications. The authority to require import certifications for food authorizes FDA, based on risk considerations, to require an article of food offered for import into the United States to be accompanied by certifications or other assurances that the food complies with relevant provisions of the FD&C Act. Certifications may be issued by designated foreign governments or accredited third parties.
3rd party auditors. Accreditation of third-party auditors directs FDA to establish a system for the recognition of accreditation bodies that accredit third-party auditors to issue certifications for purposes of the import certification for food and VQIP provisions described previously in this document.
Foreign governments, foreign cooperatives, and any other third parties (including private entities) are eligible to be considered for accreditation as third-party auditors.
The statute further provides that if FDA has not, within a specified timeframe, identified and recognized an accreditation body to meet the requirements of this provision, FDA may directly accredit third party auditors.
The statute directs FDA to issue implementing regulations, including provisions on conflicts of interest, financial ties, and unannounced audits, as well as model accreditation standards, including requirements for regulatory audit reports.
FDA Also Offering Webcast of Meeting
In addition to being able to attend the meeting in person, FDA will be offering a webcast of the event available here.
(See ITT’s Online Archives or 03/07/11 news, 11030720, for BP summary of an FDA summary of the FSMA, including the above importer provisions.
See ITT’s Online Archives or 01/04/11 news, 11010426, for a comprehensive BP summary of the FSMA, including the above importer provisions as well as other provisions which will affect imports.
See ITT’s Online Archives or 03/04/11 news, 11030435, for BP summary of an FDA official describing the importer verification activities as similar to those now required for seafood as they will require importers to establish “standards and proof” of compliance.)
FDA contact: Patricia M. Kuntze 301-796-8641, Patricia.Kuntze@fda.hhs.gov .