- FDA has issued a final rule that pushes back compliance dates and clarifies technical issues for select provisions in four of its seven FSMA rules.
- The agency said it is "providing more time for manufacturers to meet requirements related to certain assurances that their customers must provide, more time for importers of food contact substances, and other extensions to align compliance dates for various other food operations or provide time for FDA to resolve specified issues."
- Additional chapters of draft guidance for public comment will continue to roll out as completed with the FDA planning to release all chapters by early 2018.
The compliance date extensions impact provisions involving written customer assurances, food contact substances under the foreign supplier verification rule, Grade A milk products, and several others that deal specifically with agricultural facilities. The preventive controls rule for human food will go into effect for all but small businesses on Sept. 19.
The industry, through groups like Food Marketing Institute, has already expressed appreciation for additional guidance and time to comply with the rules, as many manufacturers and trade groups have approached the agency for clarification on certain provisions.
Changes needed to comply with the regulations have varied among facilities, ranging from additional documentation to entire overhauls of systems following thorough risk-based hazard analysis. But at times, manufacturers may have still been out of compliance because they needed clarification on the rules. This makes guidance all the more valuable as facilities work to reach compliance for the first rule, preventive controls, over the next month.
Depending on the survey, anywhere from 25% to 61% of manufacturers felt their facilities were FSMA compliant earlier this year. The preventive controls rule is arguably the most extensive, so once manufacturers prepare for that rule first, the other six rules may not involve as many changes.