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Safe Food Transport Rule Delayed, Intentional Adulteration Rule Still Due by Nov. 30

Friday, August 16, 2013
Sandler, Travis & Rosenberg Trade Report

The Food and Drug Administration has been given an additional two months to issue a proposed rule on the sanitary transportation of food products, but the agency’s bid for a longer delay for a proposed rule on protection against intentional food adulteration was rejected.

Earlier this summer, the U.S. District Court for the Northern District of California ordered the FDA to conclude the process of proposing regulatory changes required by the Food Safety Modernization Act by Nov. 30. The comment periods on these proposed rules must close no later than March 31, 2014, and all association final regulations must be published in the Federal Register no later than June 30, 2015.

The FDA has already published four of seven proposed regulations to implement FSMA provisions. The first two set forth procedures to ensure safe produce and require domestic and foreign food facilities to establish plans to identify and respond to food safety hazards. The second two would implement requirements regarding the Foreign Supplier Verification Program and the accreditation of third parties to conduct audits of foreign food facilities. The FDA anticipates issuing a fifth proposed rule prior to the court-ordered Nov. 30 deadline.

However, the FDA argued before the court that it needs more time to issue the two other proposed rules on sanitary transportation and intentional adulteration because of the complexity of the issues and the amount of work required. Specifically, the FDA anticipates publishing the sanitary transport rule by Jan. 31, 2014, but believes it will not be able to publish the intentional adulteration proposal until the second half of 2015, with a final rule not likely until the second half of 2017.

An FDA official said the intentional adulteration rule in particular will require additional time because this is an area the agency has not previously regulated. The FDA therefore prefers to begin by issuing an advance notice of proposed rulemaking (which is currently under review within the agency) to ask industry for information about how vulnerability is currently assessed and what measures are currently in place to guard against intentional adulteration. The Center for Food Safety (the plaintiff in the case before the court) responded by asserting that the FDA is in fact actively involved in issues involving food safety vulnerability, among other things regularly holding workshops on food security awareness and defense and publishing expert reports on the subject. Further, the CFS said, where health and safety are involved, the issuance of an ANPR is the least responsive course short of inaction and the FDA should not be permitted to slow down the rulemaking process by adding an unnecessary step.

The court agreed to extend the deadline for publication of the proposed sanitary transport rule by 60 days, to Jan. 31, 2014, and to extend the comment period on that rule for 60 days as well, through May 31, 2014. The deadline for publication of the final rule remains June 30, 2015.

However, the court denied the FDA’s request to extend the deadline for issuing the intentional adulteration proposal. While the court “understands the FDA’s position, and is in sympathy with it,” it is “unwilling to grant extension after extension, or to permit the FDA to continually delay publication of this rule, in the face of the clear Congressional directive that this be a closed-end process.”

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