The U.S. Food and Drug Administration (FDA) released two more proposals in July 2013 outlining how it will implement the Food Safety Modernization Act (FSMA). The newest proposed rules, which address foreign suppliers and third-party auditors, join proposals on preventive controls and produce safety. These rules would impact several aspects of the fresh produce supply chain, so it’s important to be informed. Here are the basics that the retail community should know:
What would the proposed foreign supplier rule require?
About 60 percent of the fresh fruits and vegetables sold in the United States are imported. This law proposes how to implement the preventive controls and produce safety rules requirement that imported food meet the same public health standard as domestically produced food. This rule would require importers to verify that by establishing and following Foreign Supplier Verification Programs (FSVPs). Unless your company is a direct importer, complying with this rule will fall to your importing suppliers.
Very small importers or foreign suppliers — those with annual sales under $500,000 — will be subject to modified requirements, not exemption.FSVP requirements would go into effect 60 days after the rule’s finalisation, though FDA is proposing that importers be given additional time — in general, 18 months later, depending upon compliance dates for the preventive controls and produce safety rules.
What would be required by the proposed rule on accreditation and certification of third-party auditors?
The food industry currently employs third parties to conduct food safety audits and certify foreign food facilities, but FDA doesn’t oversee them, and audits vary greatly. This rule proposes to change that, so retailers who currently require third-party audits from foreign suppliers should follow this rule closely.
The rule’s name is a misnomer, as its scope is broader than just audits. FDA proposes to recognise accreditation bodies, which in turn accredit third-party auditors, aka certification bodies. Moreover, the agency proposes to require direct notification of serious public health risks.
While importers generally wouldn’t be required to obtain certification, the rule proposes that FDA can request certification of high-risk foods, including foods from countries with inadequate public health protections or foods seeking expedited U.S. entry under a not-yet-established programme. Optionally, companies can seek certification to satisfy the FSVP rule’s on-site audit requirement.
Consumer groups are already opposing outsourcing of inspections, while an oversight program placed over existing third-party audit programmes will be challenging the rule. FDA intends to implement this programme as soon as possible after releasing its final rule and the separate model accreditation standards.
Learn more about all four proposed rules at www.pma.com/fsma, and please share your views with your trade associations, including PMA, so that we can ensure we are representing you in our work.
About the Author
Tom O’Brien is a representative of the Produce Marketing Association in Washington, D.C.