Today, the U.S. Food and Drug Administration (FDA) announced that they would extend for 120 days the comment period for two proposed rules that were promulgated as part of the implementation of the Food Safety Modernization Act (FSMA). The regulations, titled "Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food" (regarding preventive controls) and "Standards for Growing, Harvesting, Packing, and Holding of Produce for Human Consumption" (on produce safety), were published in the Federal Register on January 16, 2013. The comment period was originally scheduled to end on May 16, 2013, but the new, extended comment deadline ends September 16, 2013.
On April 11, over 120 industry organizations wrote to Commissioner Hamburg requesting an extension of time to comment, saying "it would be impossible for any interested party to meaningfully comment on these two proposed rules by the current deadline of May 16, 2013, given they propose such a substantial overhaul of the structure of food safety regulation."
The FDA conducted public meetings during February and March, during which time they heard from industry stakeholders and consumers about the importance of the regulations, objections to various aspects and the desire for more time to gather input and formulate substantive responses. During these meetings, stakeholders had asked FDA for the opportunity to comment on these two Proposed Rules, as well as three others yet to be released by the agency, as a "suite" of regulations. The FDA does not oppose this concept, but the remaining regulations have not been released. The regulations yet to be released include rules on a Foreign Supplier Verification Program, preventive controls for animal feed and accreditation of third parties to conduct food safety audits.
The FDA also has to take into account an April 22 California Federal Court decision criticizing the FDA for violating FSMA by not moving ahead more quickly to issue all the required rules. The court ordered the FDA to come up with new deadlines for rules by May 20, 2013. Given the complexity of the regulatory process, it is unclear how the court might force FDA to move faster.