Comment Period Extended for Two Proposed Rules and One Risk Assessment Relating to Food Safety

The FDA has extended the comment period on two proposed rules and one draft risk assessment, all published in the Federal Register on January 16, 2013. The proposed rules and draft guidance covered various food safety issues. The proposed rules’ original comment deadline of May 16, 2013, has been extended to September 16, 2013. The comment period for the draft risk assessment originally closed on February 15, 2013, was reopened on March 13, 2013, and will now remain open until September 16, 2013. The deadlines were extended based on requests from the industry for more time. The corresponding information collection provisions are also extended.

The first proposed rule, titled “Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption” would establish regulations on: (1) worker training and health hygiene; (2) agricultural water; (3) biological soil amendments; (4) domesticated and wild animal access to growing areas; (5) equipment, tools, buildings; and (5) sprouts. The second proposed rule, titled “Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food” would put requirements on facilities to establish and implement hazard and risk-based preventative controls. Facilities that manufacture, process, pack, or hold food and are required to register under section 415 of the Federal Food, Drug and Cosmetic Act (FD&CAct) would be required to comply with these regulations, unless they were exempt.

The corresponding draft risk assessment, titled “Draft Qualitative Risk Assessment of Risk of Activity/Food Combinations for Activities (Outside the Farm Definition) Conducted in a Facility Co-Located on a Farm” is intended to provide a science-based risk analysis of activity and food combinations that would be considered low risk. The FDA is seeking comments that can be used to improve: (1) the approach used; (2) the assumptions made; (3) the data used; and (4) the transparency of the draft risk assessment.