FDA to Soon Issue FSMA 3rd-Party Cert, Supplier Verification Proposed Rules
In remarks at the Global Food Safety Conference in Orlando, FL on February 16, 2012, Food and Drug Administration Deputy Commissioner for Foods Michael R. Taylor stated that the FDA will soon be publishing several proposed rules to implement parts of the Food Safety Modernization Act (FSMA). The five highest priority rules will relate to third-party certification, foreign supplier verification, preventative controls at human food and animal feed production facilities, and produce safety. Taylor stated that the FDA hopes to publish the third-party certification proposed rule in March.
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Proposed Rules to Lay Framework for FSMA Changes on Food Safety
According to Taylor, the upcoming proposed rules will reveal the basic framework the FDA has in mind for the new food safety system, and how they expect the FSMA will work in practice. The five highest priority rules include:
Third-Party Certification. This proposed rule will address accredited third-party certification, in which the FDA will recognize accrediting bodies and set standards for accreditation of third-party certification bodies and auditors aimed at ensuring the rigor, objectivity, and transparency of third-party audits. According to Taylor, FDA hopes to publish proposed this rule in March.
Foreign Supplier Verification. Rather than placing primary reliance on FDA inspectors detecting and correcting problems at the port of entry, FSMA makes importers accountable for verifying, in a manner transparent to FDA, that the food they import has been produced in accordance with U.S. standards, or modern preventative controls that provide the same level of public health protection. This proposed rule will lay out how importers can meet this new requirement.
Preventative Controls at Human Food Facilities. FDA will propose that facilities that process human food be required to establish modern preventative controls that are consistent with internationally recognized principles of Hazard Analysis and Critical Control Points (HACCP) and address supplier verification activities that relate to the safety of food.
Preventative Controls at Animal Feed Facilities. Animal Feed Facilities are also subject to the preventative controls mandate but will be addressed in a separate but similar proposed rule that takes into account some differences in how preventative controls would work in human and animal feed facilities.
Produce Safety. The produce safety proposed rule will set out science- and risk-based standards for the safe production and harvesting of fruits and vegetables, addressing such areas as water quality, employee hygiene, soil amendments, and animal intrusion in growing fields.
(See ITT’s Online Archives 11010426 for a comprehensive summary of FSMA, including the stipulation that FDA issue regulations to provide for the content of the foreign supplier verification program no later than one year after enactment of FSMA (January 4, 2012), a target date that was not met. See also ITT’s Online Archives 11092234 for summary of a report by an FDA official that the issuance of foreign supplier verification regulations will be delayed to coincide with the issuance of the preventative controls rules, which is required to be completed by July 4, 2012.)