August 21, 2013

FDA Orders Environmental Impact Statement on FSMA’s Produce Rule

From: Food Safety News

By Dan Flynn

The produce rule – one of seven specific regulations called for in the Food Safety Modernization Act – is first going to be subjected to a full-blown Environmental Impact Statement (EIS) before it takes effect. With at least one federal judge already breathing down the agency’s neck over completion deadlines contained in the FSMA, the U.S. Food and Drug Administration (FDA) is promising the easy-to-bog-down environmental process won’t delay the final rule.

“FDA is conducting the EIS because it has received information through comments and its own analysis that an environmental analysis is needed,” said an announcement issued on Aug. 16. “The agency is already assessing the issues that may give rise to significant impacts from the standpoint of the environment and the practicality of the rules and alternative ways to achieve the food safety goal.”

“Because FDA is paralleling its own assessment of the issues with the EIS process, the Agency doesn’t anticipate that the EIS will delay final deliberations but will help by generating additional data and analysis and processing opportunity for stakeholder engagement,” it added.

FDA recently extended the comment period on the proposed rule to Nov. 15, 2013.

FDA said it was beginning the “scoping process” for the EIS to determine the issues and extent of the environmental analysis that will be required. In addition to the public at large, the agency will be reaching out to other federal agencies, states and tribal governments.

Most of the visible action on FSMA rulemaking has occurred since President Obama was reelected in 2012. Although he signed the bill in January 2011, rulemaking was pretty much stalled in the White House’s regulatory shop in the Executive Office of Management and Budget (OMB) during the election year that followed.

By August 2012, some had outgrown their patience. The Center for Food Safety and Center for Environmental Health sued FDA because the deadlines for all the rules had been missed.

FDA has since published four of the regulations for review, including the produce rule. And U.S. District Court Judge Phyllis J. Hamilton ruled with the plaintiffs by imposing a schedule on FDA.

But FDA was back in the U.S. District Court for Northern California last month asking for a delay for completing the last two rules – one involving sanitary transport and the other about intentional adulteration. This time Hamilton, appointed to the federal bench by President Bill Clinton, split the difference.

She gave FDA a final deadline for the sanitary transport rule of May 31, 2014, a date requested by Michael R. Taylor, FDA’s deputy director for foods and veterinary medicine. In a declaration to the court, Taylor said FDA would not be able to propose an intentional adulteration rule until the second half of 2015, nor finish it until the second half of 2017. The judge, however, left the 2014 deadline intact for the intentional adulteration rule.

“The court understands FDA’s position, and is in sympathy with it, but remains of the opinion that the dispute here is between the FDA and Congress,” Hamilton said.

Comments for the EIS scoping process may be submitted electronically  on using the docket number FDA-2011-N-0921.

To submit comments by mail, send to FDA at: Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD, 20852. All submissions must include the agency name and docket number FDA-2011-N-0921.

For more information: Federal Register Notice: Notice of Intent to Prepare an Environmental Impact Statement for the Proposed Rule – Standards for Growing, Harvesting, Packing, and Holding of Produce for Human Consumption.


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