Tuesday 20 February 2018

Final Comment Period Extension for Preventative Controls and Produce Safety Rule

The US FDA today issued Federal Register notices to extend the comment periods on the proposed rules for Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food  (a/k/a “Preventative Controls” or “HARPC” rule) and Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption (a/k/a Produce Safety Rule) 60 days until November 15, 2013. This is the second and final extension of the comment period for the two rules. The extension of the comment period also applies to the information collection provisions associated with the proposed rules.

FDA is taking this action to allow interested persons the opportunity to consider the interrelationships between these two proposals, which were published on January 16, 2013, and the two new proposed rules that published on July 29, 2013, Foreign Supplier Verification Programs for Importers of Food for Humans and Animals and the Accreditation of Third-Party Auditors/Certification Bodies to Conduct Food Safety Audits and to Issue Certifications.

The announcement not sets a final date to measure the date when the rule will be come effective. The Rules are effective 60 days after the comment period ends, in this case January 15, 2014. Enforcement of the new rules won’t take place for another year after that and in some cases longer depending on the approach taken by the rule. Most facilities will be expected to comply with the rule by January 15, 2015.

Also, recall the DC Circuit decision earlier this year dismissing a challenge to a USDA rule (read the post here). In that case the challenger, a California farmer, failed to comment on the proposed rule leading the court to rule the farmer waives their right to challenge the rule. As enforcement begins challenges no doubt will be brought, but those challenges will be quickly dismissed if there was no comment submitted during the comment period. Time is running out – be sure to comment!

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