FDA Gives Importers More Time to Comply with FSVP Written Assurance, Food Packaging Material Requirements
The Food and Drug Administration is pushing back certain compliance dates for its Food Safety Modernization Act regulations, including deadlines for some importers to comply with the Foreign Supplier Verification Program, it said in a notice (here). FDA will now give food facilities, farms and importers an extra two years to implement provisions that allow them to rely on downstream customers to control food safety hazards if they get written assurances from those customers. The agency will also give importers another two years to comply with FSVP requirements for food contact surfaces, and extend other deadlines for provisions of its preventive controls rules for human and animal food safety facilities and produce safety rule for farms.
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The extension of the customer written assurance deadline addresses concerns that complex product distribution chains “would require vastly more written assurances and consequently resources to comply with the requirement than anticipated by FDA,” the agency said. Under these provisions, a food manufacturer or processor, farm or importer does not have to control or verify control of a hazard if it provides documentation to its downstream customer that it does not control the hazard, and receives written assurance from the customer that the hazards are being addressed. According to the Grocery Manufacturers Association, which raised the issue with FDA in March, some distributors with many customers could require “hundreds or even thousands of written assurances.” The two-year delay gives time for FDA to consider “the best approach to address feasibility concerns,” the agency said.
Written assurance requirements for FSVP importers were originally set to take effect at the same time they were required to comply with other provisions of FSVP, i.e., the later of May 30, 2017, or six months after their supplier is required to comply with preventive controls or produce safety regulations (see 1511160014 and 1602120038). As a result of the extension, FSVP importers relying on customers to address food safety hazards will not have to comply with the written assurance requirement until May 28, 2019, at the earliest, or 30 months after their supplier is required to comply with preventive controls or produce safety regulations, whichever is later.
Similarly, compliance with written assurance requirements for facilities subject to the human food preventive controls regulations will now be required by Sept. 18, 2019, for small businesses and Sept. 19, 2018, for all other businesses. The compliance date for facilities subject to animal food preventive controls regulations will now be Sept. 17, 2020, for small businesses and Sept. 18, 2019, for all other businesses. Compliance with written assurance requirements for farms subject to FDA’s produce safety rule will not be required until Jan. 27, 2019, at the earliest for sprouts and Jan. 27, 2020, at earliest for other covered produce, depending on business size.
FDA is also giving importers of food contact substances an extra two years to comply with FSVP requirements, until May 28, 2019. After meeting with food packaging industry representatives, “FDA believes that compliance with the requirement to conduct verification activities under the FSVP regulation for food contact substances by May 30, 2017,” the original compliance date, “might not be feasible.”
FDA is also extending by about one year and four months compliance dates under the human and animal food preventive controls regulations for facilities solely engaged in packing or holding activities for produce raw agricultural commodities (RACs) or nuts and shells, and facilities that would qualify as second activities farms except for ownership of the facility. Facilities that color RACs will get an additional one year and four months to comply with the human food preventive controls rules, while facilities that only engage in the ginning of cotton will get an extra 16 months to comply with animal food preventive controls regulations. Grade “A” milk and milk products covered by the Pasteurized Milk Ordinance will now have until Sept. 17, 2018, to comply with all human food preventive controls requirements, FDA said. The agency’s notice also clarifies compliance dates for agricultural water requirements of the produce safety regulations.