It has been approximately 16 months since passage for the Food Safety Modernization Act (FSMA), yet key rulemaking provisions of the law are currently being held up at the White House’s Office of Management and Budget (OMB), even though President Obama has been a strong supporter to the legislation. Moreover, a number of industry groups, including the Grocery Manufacturers Association (GMA), Produce Marketing Association and Pew Health Group, have recently written the White House urging full and timely implementation of the law by the U.S. Food and Drug Administration (FDA). OMB has responded to the criticism by saying it is working as “expeditiously as possible” to implement the legislation.

The FSMA is intended to provide FDA with additional regulatory tools to prevent food-borne illnesses. In part, provisions of the law require produce farmers, food-processing facilities and animal-food plants to put in place safety measures to help the food industry identify and combat food-safety hazards. The law also requires food imports to comply with the same safety standards as domestically produced food products. To put these provisions in place, the OMB must approve rulemakings drafted by FDA, which are then submitted to the public for comment before being finalized. By executive order, OMB has 90 days to review proposed regulations. However, the target deadline for finalizing the food imports rule (January 4, 2012) past several months ago, and the food safety provisions covering produce are also behind schedule. While it is not uncommon for OMB to extend its review, the noted draft food safety rules have now been sitting at OMB for six months or longer.

One question currently being discussed here in Washington, DC is who, if anyone is currently opposing further implementation of FSMA? Some believe that OMB has raised concerns about FDA’s cost/benefit analysis related to implantation of the law. FDA itself has noted that it has conducted numerous meetings with affected parties and believes opposition from industry is minimal at this point. Others point to the fact that 2012 is a Presidential election year, which can often complicate the passage and implementation of new laws and regulations. For additional information of this issue, please contact Georgia C. Ravitz, James R. Ravitz, or James Hartten at Arent Fox.