FDA has announced that it will extend for an additional 120 days the comment periods for two major proposed rules implementing the Food Safety Modernization Act (FSMA): preventive controls for human food (Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food) and produce safety standards (Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption). The extended comment period will close September 16, 2013.
The comment period extensions apply to the proposed rules, their information collection provisions, as well as the draft risk assessment FDA prepared for on-farm activity/food combinations deemed to be low-risk (Draft Qualitative Risk Assessment of Risk of Activity/Food Combinations for Activities (Outside of the Farm Definition) Conducted in a Facility Co-Located on a Farm).
Many companies and trade associations that are only beginning to get their arms around these complex and inter-related proposed regulations will breathe a sigh of relief. The reactions of consumer groups and certain members of Congress, such as Rep. Rosa DeLauro (D-CT), who have been pushing for speedy implementation of FSMA, are likely to be less enthusiastic.
The FDA announcement comes just two days after a federal court held that FDA had violated the Administrative Procedures Act by failing to meet the statutory deadlines set forth in FSMA. In a lawsuit in the Northern District of California, the district court ordered FDA to develop, in consultation with the two consumer groups that brought the suit, a new timetable for implementation of FSMA. FDA has not yet issued a public comment on the court order or indicated whether it intends to appeal. However, the comment period extension indicates that FDA leadership believes the foundational regulations implementing FSMA cannot be rushed.