On September 29, 2014, the Food and Drug Administration (FDA) published in the Federal Register for public comment four supplemental notices of proposed rules addressing specific provisions of the Food Safety Modernization Act from the various original proposals, based on comments reviewed so far.

The four Supplemental Notices of Proposed Rulemaking are:

1. Supplemental Notice of Proposed Rulemaking for the Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption. Docket number FDA-2011-N-0921 (http://www.gpo.gov/fdsys/pkg/FR-2014-09-29/pdf/2014-22447.pdf.) This is the produce/farm rule and also impacts produce packinghouses located on farms.


2. Supplemental Notice of Proposed Rulemaking for the Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food. Docket number FDA-2011-N-0920 (http://www.gpo.gov/fdsys/pkg/FR-2014-09-29/pdf/2014-22446.pdf.) This is the manufacturing/processing rule and also impacts produce packinghouses not located on farms.


3. Supplemental Notice of Proposed Rulemaking for the Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Food for Animals. Docket number FDA-2011-N-0922 (http://www.gpo.gov/fdsys/pkg/FR-2014-09-29/pdf/2014-22445.pdf.) This is the manufacturing/processing rule for animal food.


4. Supplemental Notice of Proposed Rulemaking for the Foreign Supplier Verification Program for Importers of Food for Humans and Animals. Docket number FDA-2011-N-0143 (http://www.gpo.gov/fdsys/pkg/FR-2014-09-29/pdf/2014-22448.pdf.) 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.

Stakeholders 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 (http://www.regulations.gov) by the due date of December 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.

Should you have questions about FDA's supplemental proposed rules or any other FDA-related issue, contact FDA at FSMA@fda.hhs.gov.

Article written by Rob Neenan, President/CEO, California League of Food Processors