Proposed Food Safety Modernization Act Rules Open for Comment

The Food Safety and Modernization Act (FSMA), which was signed into law on January 4, 2011, directs the Food and Drug Administration (FDA) to draft rules to better protect public health by helping ensure the safety and security of the U.S. food supply. The first four significant FSMA rules have either been published in the Federal Register, or will be soon. These rules include:

  • Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventative Controls for Human Food (published January 16, 2013; 78 Fed. Reg. 3646);
  • Standards for the Growing, Harvesting, Packing and Holding of Produce for Human Consumption (published January 16, 2013; 78 Fed. Reg. 3503);
  • Foreign Supplier Verification Programs for Importers of Food for Humans and Animals; and
  • Accreditation of Third Parties to Conduct Food Safety Audits.

The preventative control rule has two major features. First, it contains new provisions requiring each owner, operator, or agent to comply with hazard analysis and risk-based preventative controls. Second, it would revise existing Current Good Manufacturing Practice (CGMPs) requirements by clarifying that certain existing CGMP provisions would also require protection against cross-contact of food by allergens. The proposed rule provides many small business exemptions. The rule takes effect 60 days after the final rule is published in the Federal Register; however, small businesses (defined as having less than 500 employees) have two additional years to comply, and very small businesses have three additional years to comply. (Three possible definitions of small businesses are proposed: entities having less than $250,000, $500,000, or $1 million in total food sales.)

In the produce rule, the FDA proposes to set standards associated with the identified routes of microbial contamination of produce, including:

  • agricultural water;
  • biological soil amendments of animal origin;
  • health and hygiene;
  • animals in the growing area; and
  • equipment, tools and buildings.

The rule would become final 60 days after final publication in the Federal Register. There are numerous small business exemptions. Small businesses (defined as entities with average annual food sales over the previous three years of no more than $500,000) would have three years to comply; very small businesses (average annual food sales over the previous three years of no more than $250,000) would have four years to comply.

The comment deadline for both rules is May 16, 2013. Submit electronic comments through the Federal eRulemaking Portal: www.regulations.gov.

—Linwood Rayford, Assistant Chief Counsel

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