FDA Issues Proposed Rules And Explanatory Fact Sheets For FSMA


On January 4, 2013, the Food and Drug Administration (FDA) issued two long-awaited proposed rules implementing important aspects of the 2011 Food Safety Modernization Act (FSMA).  These rules are intended to help prevent foodborne illnesses by ensuring stricter and more effective preventive and protective measures in key areas of the food supply chain.  On January 9, 2013, the FDA issued fact sheets providing summaries, background and highlights of the proposed rules.

One of the proposed rules addresses food safety issues for facilities that manufacture, process, pack or hold human food.  These rules would require each facility to prepare a food safety plan to prevent contamination and to be prepared to respond in the event of contamination.  These plans would be similar to the HACCP (Hazard Analysis and Critical Control Points) plans currently required for juice and seafood facilities.  

The other proposed rule concerns food safety issues for produce and addresses growing, harvesting, packing and holding of produce for human consumption.  Specific issues addressed by the proposed rule include:  agricultural water; biological soil amendments; health and hygiene; animals in the growing area; and equipment and facilities.  In addition, the FDA issued a draft qualitative risk assessment for food production activities that are co-located on farms. 

The proposed rules include certain exemptions and delayed phase-in periods for smaller businesses.  Companies would generally have one year to comply with the manufacturing safety rules and two years to comply with the produce safety rules.  Accounting for delays in issuing the final rules for the FDA to consider and respond to filed comments, compliance with the final rules may not be required until late 2014 and 2015, respectively, or even later. 

Comments on the two proposed rules and the draft risk assessment are due within 120 days. 

The FDA will issue additional proposed rules in the near future, including rules requiring companies to verify that their foreign suppliers are meeting safety standards.

The full text of the proposed rules can be found at:

The fact sheets for the proposed rules can be found at:

Contact counsel for more information about these proposed rules or assistance in filing comments.

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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