Regulatory Follow up: FDA FSMA Produce Safety – FINAL RULE

U.S. Food and Drug Administration (FDA) released final rules implementing Food Safety Modernization Act (FSMA), including the PRODUCE SAFETY RULE.

By Alesia Bock, AgriSystems International

After extensive public comment was received by FDA as part of their Proposed Produce Safety Rule earlier this year, the Final Rule as published in November 2015 appears to have been revised to reflect the unique needs of the Organic system. This is great news for organic producers.

Washington D.C. (November 2015)– OTA and it’s members were integrally involved over the last several months to ensure that member feedback on behalf of the Organic Industry was provided back to FDA regarding their proposed Produce Safety Rule. It was critical to provide this feedback, as several areas of the rule including Agricultural Water and Compost, will have direct impact on Organic producers.

Comments from OTA’s Laura Batcha, CEO/Executive Director:
“OTA worked hard to provide extensive input from the Organic Sector to help FDA formulate a new improved food safety system that meets the needs of both organic farmers and organic eaters, and will provide safe food for all Americans. We applaud the FDA for their commitment to this task. The organic sector supports regulations that ensure the safest food for all, and the final regulations demonstrate the confidence that the public should have in the organic production system.”

Regarding Manure and Compost:
FDA listened to the organic industry feedback, and revised the Final Rule to be consistent with the supplemental rule to eliminate the waiting time for properly produced compost, and defer the 9-month minimal interval requirement for untreated manure. Until further research on an appropriate interval is determined, organic producers will continue to follow the established USDA NOP regulations for application of raw manure.

Regarding Agricultural Water:
The final water standard reflects a more realistic risk-based approach to testing, which will minimize additional economic hardship on organic farmers.

Regarding Packing and Distribution Centers:
The final regulations supports a collaborative approach to local and regional agriculture, and reduces additional burdens for those operations that pack and distribute produce on their own farms or neighboring farms.

Regarding Biodiversity:
FDA’s final language states that these new regulations won’t require organic farmers to exclude animals from outdoor growing areas or destroy animal habitat, which would have been in direct conflict with USDA NOP’s requirement for farmers to maintain and improve natural resources and biodiversity on their farms.

We are very pleased that FDA requested public comment and listened to the feedback provided by Organic growers/producers. It will truly help to continue to build the organic industry while providing safe food for consumers.

Full OTA press release here:

FDA Food Safety Modernization Act

Alesia Bock is the Owner/ Managing Director of AgriSystems International, providing consulting services related to organic certification and sustainable business development for food growers and processors. Over her 25-year career in Quality & Regulatory in the food industry, she has dedicated the last 15 years to increasing the availability of natural/organic options for consumers. She can be reached at