The Food Safety Modernization Act (FSMA), signed into law on January 4, 2011, requires the Food and Drug Administration (FDA) to undertake sweeping regulatory action to strengthen the safety of the nation’s food supply. Many of the items on FDA’s “to do” list require significant and swift action. Over the next two years, FDA must engage in a number of rulemakings and issue several guidance documents to implement the FSMA.
FDA must take certain actions in 2011, including:
- Issue guidelines regarding new dietary ingredients in dietary supplements
- Promulgate facility registration suspension guidelines
Several of FDA’s action items must be completed by January 4, 2012, including:
- Issue notice of proposed rulemaking regarding safe fruit and vegetable harvest and processing
- Designate high-risk foods requiring additional recordkeeping
- Promulgate rules establishing the foreign supplier verification program for importers
- Develop and publish a list of acceptable customer notification methods that grocery stores may use to post recall information
Other action items affecting a large portion of the food industry have a July 4, 2012 deadline:
- Promulgate regulations establishing science-based minimum standards for hazard analyses and preventive controls
- Promulgate rules regarding the sanitary transportation of food
Industry stakeholders should determine how the new law affects them and prepare to participate in the notice and comment process. For a copy of the Kelley Drye client advisory regarding the FSMA, please click here. For a timeline of all FDA actions required under the FSMA, please click here.