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OMB Extends Review of FDA Proposed Rule on Foreign Supplier Verification

The Office of Management and Budget has extended its review of a Food and Drug Administration proposed rule that would establish regulations concerning the content of foreign supplier verification programs. The regulations would require that each importer have a foreign supplier verification program that is adequate to provide assurances that each foreign supplier produces food in compliance with: (1) processes and procedures that provide the same level of public health protection as those required under section 418 (concerning hazard analysis and risk-based preventative controls) or section 419 (concerning produce safety standards) of the Food Drug and Cosmetic (FD&C) Act; and (2) sections 402 (concerning adulteration) and 403(w) (concerning major food allergens) of the FD&C Act.

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(See ITT's Online Archives 12022414 for summary of the FDA Commissioner's remarks stating that the agency would 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. The third-party certification proposed rule was expected in March 2012.)