September 10, 2015  -  FDA has released the pre-publication texts in advance of the September 17 Federal Register Notices. Our professional regulatory-science readers will now be able to check the Final Rules for key changes from our anticipated revisions of the Proposed Rules. In the weeks ahead, you will see numerous articles in the general and business press, written primarily by unqualified individuals who will tell you “more than they know” about these major changes to long-established food industry practices. The pre-publication texts of the Human Food and Animal Feeds Final Rules run 930 pages and 666 pages respectively. These are science-based rules written by and for Food Scientists and experienced food plant-management personnel. Thus, articles or presentations on their interpretation written by non-credentialed scientists should viewed with great caution.

I have written two articles in past year on this subject and have oriented my course in “US Food Import Regulation” (taught at MSU in the past two academic years) to extremely narrow aspects of FSMA and the RBPC Rule. My forthcoming article, “Obligation of Food Importers to Ensure that Food Packaging is Compliant with FDA Food Contact Substance Regulations” will deal with another technical aspect of the new Final Rules.

Attached below are the 1,500 pages of the first two Final Rules. There are six more Final Rules to come, so our readers can look forward to more than 5,000 pages to study in the months ahead. Enjoy!

Appology to readers - files are too large - working on technical upload issues