On Nov. 13, the U.S. Food and Drug Administration (FDA) published three final rules as part of implementing the Food Safety Modernization Act (FSMA). Below you will find links to each rules’ fact sheet and more information from FDA.
FDA has done a commendable job in gathering stakeholder input and providing an opportunity for the food industry to express their concerns and provide comments on proposed FSMA rules. As such, these three final rules reflect many, but not all, of the suggested amendments PMA and other leading food trade organizations have recommended in their comments to FDA over the last few years.
We are currently in the process of reading and assessing the hundreds of pages of text these rules encompass and will be developing educational outreach materials to assist PMA members in understanding and implementing these rules. Upon initial review, the following is a summary of key elements of the rules that we want to draw your attention to:
Produce Rule:
- This regulation affects both international and domestic produce growers, in that it establishes science-based standards focused on the growing, harvesting, packing and holding of produce on-farms.
- The key provision areas include agricultural-water quality standards and testing, standards for using raw manure and compost, training, control of domestic and wild animals, equipment, tools, buildings, sanitation as well as worker health and hygiene.
- This on-farm produce safety regulation is significant in that FDA will now put in place an enforceable implementing regulation that explicitly articulates on-farm standards of conduct for the safe growing, harvesting, packing and holding of fresh produce.
FSVP Rule:
- This regulation addresses import safety and is closely tied to the FSMA Preventive Controls for Human Foods Rule and Produce Rule requirements.
- Importers are required to verify that food imported into the U.S. has been produced to the same food safety standards that are required of U.S. producers.
- Food importers are required to develop Foreign Supplier Verification Programs (FSVP) that verify compliance with U.S. standards, including the FSMA Preventive Controls for Human Foods Rule and Produce Rule requirements.
3rd-Party Accreditation Rule:
- This regulation aims to establish a comprehensive, credible and reliable program of oversight based on third‐party audits and certification of foreign food facilities to help FDA make decisions regarding the admissibility of imported foods.
- This regulation does NOT set forth the exact criteria to which firms will be held accountable during audits. Those criteria will be specified in the FSMA Preventive Controls for Human Foods Rule and Produce Rule requirements.
Webinars help industry prepare
The publication of these final rules by FDA is a major FSMA implementation milestone for this landmark legislation. These rules will have a significant impact on produce businesses, in that they will affect how businesses operate on a daily basis and set definitive regulatory compliance expectations for FDA regulated businesses.
To that end, PMA and United Fresh Produce Association, in partnership with regional produce trade organizations, are once again working in partnership to provide free webinars to help industry members understand the final rules and implications for their businesses. Each of these 90-minute webinars will provide you with opportunities to interact with FDA and ask questions. Registration is now available online.
Looking ahead
As you likely know, FDA published the first of the final rules, the Preventive Controls for Human and Animal Food rules, in mid-September. Other final rules, such as the Mitigation of Intentional Adulteration Rule and Sanitary Transportation of Human and Animal Food Rule, are expected to be released in early 2016.
It’s also anticipated the agency will soon be issuing important companion guidance documents for all final FSMA rules that will provide more detailed information about coverage and compliance requirements. There will be an opportunity to provide comments on these upcoming draft guidance documents, so stay tuned.
In the meantime, PMA will continue to work closely with allied organizations, FDA and Congress to assure that FDA FSMA implementation is realistic and well-supported.
