FDA Rolls Out More FSMA Rules

November 16, 2015

By Ricardo Carvajal

FDA released pre-publication versions of the three final rules on foreign supplier verification program (FSVP), accredited third-party certification, and produce safety.   As with the recently issued rules on CGMPs and preventive controls for human and animal food (see our previous post here), FDA issued a variety of supporting materials.  For the FSVP rule, these include a fact sheet and a flow chart to help determine applicability.  For the third-party certification rule, FDA issued a fact sheet; the agency had previously issued draft guidance on model accreditation standards.  For the produce safety rule, FDA issued a fact sheet and a flow chart to help determine applicability, as well as the agency’s Final Environmental Impact Statement, and the Final Qualitative Assessment of Risk to Public Health From On Farm Contamination of Produce.  FDA also scheduled webinars to explain significant provisions of these three rules.

Compliance with the FSVP rule generally will be required 18 months after publication of the rule, but different compliance dates may apply in the case of (1) importation of food from a supplier subject to the preventive controls or produce safety rules and their staggered compliance dates, or (2) an importer that is subject to the supply-chain program requirements in the preventive controls final rules.  The implementation date for the third-party certification program remains uncertain because it hinges on the publication of a final guidance on Model Accreditation Standards and a final user fee rule.

The compliance dates for the produce safety rule are staggered according to business size and are explained in FDA’s fact sheet.  For larger businesses, the compliance date is two years after the effective date of the final rule (or one year in the case of covered activities involving sprouts), with a two-year extension for certain aspects of water quality standards and related provisions.  Small and very small businesses will be given an additional one and two years, respectively.  However, there are separate compliance dates for modified requirements for farms that are eligible for a qualified exemption.

The publication of these three rules leaves just two of the seven major rules pending, namely sanitary transportation (expected in March 2016) and intentional contamination (expected in May 2016).  Although publication of the rules is a significant milestone, the agency’s accompanying press release recognizes that much remains to be done – and reiterates a pitch for adequate funding to enable full implementation.