On Sept. 29, the Food and Drug Administration published in the Federal Register for public comment four supplemental proposed rules addressing specific provisions from the various original proposals, based on comments reviewed so far.
The United States Department of Agriculture has no formal role in the development or implementation of the proposed rules for the FDA Food Safety Modernization Act.
The four Supplemental Notices of Proposed Rulemaking are:
- Supplemental Notice of Proposed Rulemaking for the Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption. This is the produce/farm rule and also impacts produce packinghouses located on farms.
- Supplemental Notice of Proposed Rulemaking for the Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food. This is the manufacturing/processing rule and also impacts produce packinghouses not located on farms.
- Supplemental Notice of Proposed Rulemaking for the Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Food for Animals. This is the manufacturing/processing rule for animal food.
- Supplemental Notice of Proposed Rulemaking for the Foreign Supplier Verification Program for Importers of Food for Humans and Animals. This is the importer rule.
These supplemental proposed rules are key components of the preventive approach to food safety established by FSMA. They only include the major areas where FDA is re-proposing new language from the original proposal, so areas that are not being re-proposed are not being published again. FDA continues to review all comments received on the original proposals and will take them into account as they move forward in the rulemaking process, including new comments submitted on these four supplemental proposed rules.
The produce industry, other stakeholders, and the general public are being asked to participate in the rulemaking process by reviewing the supplemental proposed rules and submitting comments to FDA or at the regulations.gov portal by the due date of Dec. 15, 2014. The regulations for these four rules will become effective only after the final rules are published in the Federal Register along with established compliance dates.
Food and Drug Administration