FDA FSMA and Small Business

The FDA Food Safety Modernization Act (FSMA) recognizes the role of small businesses in the food industry and provides for various ways to assist small businesses in meeting the new food safety requirements of the law. Specifically for several key provisions, the law mandates “plain language” guidance documents and phased-in effective dates. These include:

Registration

• FDA will issue “plain language” guidance on registration procedures for small entities within 6 months of issuing registration rule. (Section 102 of FSMA)

Hazard Analysis and Preventive Controls

• FDA will issue “plain language” guidance for small entities within 6 months of issuing hazard analysis/preventive control rule. (Section 103 of FSMA)
• Hazard analysis/preventive control rule takes effect for small businesses 6 months after effective date, and for very small businesses 18 months after effective date. (Section 103 of FSMA)

Produce Safety

• FDA will issue “plain language” guidance for small businesses within 6 months of issuing produce safety rule. (Section 105 of FSMA)
• Produce safety rule takes effect for small businesses 1 year after effective date, and for very small businesses 2 years after effective date. (Section 105 of FSMA)

Tracking and Tracing

• FDA will issue “plain language” guidance for small businesses within 6 months of issuing rule on tracking and tracing food and recordkeeping. (Section 204 of FSMA)
• Rule on recordkeeping takes effect for small business 1 year after effective date, and for very small businesses 2 years after effective date. (Section 204 of FSMA)

Training and Education

• FDA will enter into agreement with USDA to establish 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 of FSMA)

Training

Food Safety Preventive Controls Alliance

FDA, in cooperation with the Institute for Food Safety and Health, has created the Food Safety Preventive Controls Alliance to develop training courses and materials to help industry, particularly small- and medium-sized companies, comply with the upcoming preventive control rules.

Fees

See Fees under the FSMA.

Guidance and Dockets

• Burden of Food and Drug Administration Food Safety Modernization Act Fee Amounts on Small Business
  Notice; Request For Comments
  Docket Number: FDA-2011-N-0529
• Food Safety Modernization Act Domestic and Foreign Facility Reinspections, Recall, and Importer Reinspection User Fee Rates for Fiscal Year 2012
  Notice; Request For Comments
  Docket Number: FDA-2011-N-0528, Correction Notice