FDA to Issue Guidance on FSMA Food Safety Rules for Small Entities
The Food and Drug Administration has announced that it will provide guidance documents and phased-in effective dates for several key provisions of the Food Safety Modernization Act (FSMA) to assist small businesses in the food industry in meeting the new safety requirements of the law.
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(The FSMA (Public Law No. 111-353) was enacted on January 4, 2011 and provides FDA with new enforcement authorities to help it achieve higher rates of compliance with prevention- and risk-based food safety standards and to better respond to and contain problems when they do occur. The law also gives FDA new tools to better ensure the safety of imported foods and directs FDA to build an integrated national food safety system in partnership with state and local authorities. See ITT’s Online Archives or 01/04/11 news, 11010426, for comprehensive BP summary of the law.)
Guidance Documents Will be Issued on Registration, Tracking & Tracing, Etc.
FDA states that it will issue "plain language" guidance documents and effective dates for the following key provisions of the FSMA:
Registration. FDA will issue guidance on registration procedures for small entities within 6 months of issuing a registration rule. (Section 102)
Hazard Analysis and Preventive Controls. FDA will issue guidance for small entities within 6 months of issuing a hazard analysis/preventive control rule. The hazard analysis/preventive control rule will take effect for small businesses 6 months after the effective date, and for very small businesses, 18 months after the effective date. (Section 103)
Produce Safety. FDA will issue guidance for small businesses within 6 months of issuing a produce safety rule. The produce safety rule will take effect for small businesses 1 year after the effective date, and for very small businesses, 2 years after the effective date. (Section 105)
Tracking and Tracing. FDA will issue guidance for small businesses within 6 months of issuing a rule on tracking and tracing food and recordkeeping. The rule on recordkeeping will take effect for small business 1 year after the effective date, and for very small businesses, 2 years after the effective date. (Section 204)
Training and Education. FDA will enter into an agreement with the U.S. Department of Agriculture to establish a competitive grant program within the National Institute for Food and Agriculture to provide food safety training, education, extension, outreach, and technical assistance to farmers, small food processors and small fruit and vegetable merchant wholesalers. (Section 209)
(See ITT's Online Archives or 08/09/11 news, 11080916, for BP summary of FDA outlining the import safety mandates of the FSMA and listing the provisions of the FSMA that have been implemented as of August 2011.)