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Congress Considers Further Delays in Food Safety Rules; FDA Extends Comment Period

Tuesday, November 19, 2013
Sandler, Travis & Rosenberg Trade Report

A number of regulations implementing the Food Safety Modernization Act could be further delayed if Congress approves a House-backed provision as part of the farm bill currently under consideration. This provision could make it more difficult for the FDA to comply with a federal court order directing the agency to issue all FSMA final rules no later than June 30, 2015. In the meantime the FDA has given interested parties an extra week to comment on two FSMA proposals.

In a Nov. 14 letter to the leaders of the House and Senate committees on agriculture, several lawmakers stated that the farm bill provision would prevent the FDA from enforcing any FSMA regulations until it publishes in the Federal Register a scientific and economic analysis on FSMA’s impact on a variety of kinds of farms and food processors. While this provision is apparently intended to address concerns about a rule on produce safety, the letter said, as written it would “needlessly delay” the enforcement of any FSMA rules, including pending regulations on the safety of imported foods, laboratory testing standards, and better traceability for high-risk foods. The use of rules already in force would be halted as well. The lawmakers therefore requested that this provision not be included in any farm bill conference report.

Earlier this year, the U.S. District Court for the Northern District of California ordered the FDA to conclude the process of proposing regulatory changes required by FSMA by Nov. 30. The comment periods on these proposed rules must close no later than March 31, 2014, and all associated 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. One of these would establish science-based minimum standards for the safe growing, harvesting, packing and holding of fruits and vegetables grown for human consumption, while another would apply to human food and require domestic and foreign facilities that are required to register under the Federal Food, Drug and Cosmetic Act to have written plans that identify hazards, specify the steps that will be put in place to minimize or prevent those hazards, monitor results, and act to correct problems that arise. Due to technical difficulties with a Web site where the public can submit comments on federal regulatory proposals, the FDA has extended the public comment period on these two proposals through Nov. 22.

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