New FSMA rules: Produce, Foreign Suppliers and Third-Party Accreditation

The U.S. Food and Drug Administration (FDA) has published three more final rules as part of implementing the Food Safety Modernization Act (FSMA). These new rules affect international and domestic produce growers, address import safety and outline guidance for food companies importing from foreign suppliers as well as outline a plan for establishing a comprehensive and reliable program for third‐party audits and certification of foreign food facilities. Here's a breakdown of each new rule with just a couple of the highlights:  

New Rules Affecting Produce Growers

• The new Produce Rule affects both international and domestic produce growers and 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.   

• 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.    

New Rules Surrounding 3rd-Party Accreditation 

• 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.    

• Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption (Produce Rule),   
• Foreign Supplier Verification Program (FSVP), and
• Accreditation of Third-Party Auditors/Certification Bodies to Conduct Food Safety Audits and to Issue Certifications (3rd-Party Accreditation). 

Sources: FDA, PMA