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FDA to revise FSMA rules

Michael Taylor

Michael Taylor

Reacting to criticism from the farm community, the Food and Drug Administration will revise two Food Safety Modernization Act rules and will seek comment on them, FDA Deputy Commissioner for Foods and Veterinary Medicine Michael Taylor announced Thursday.

“Based on our discussions with farmers, the research community and other input we have received, we have learned a great deal, and our thinking has evolved,” Taylor said.

The provisions to be changed include water quality standards and testing, standards for using raw manure and compost, certain provisions affecting mixed-use facilities, and procedures for withdrawing the qualified exemption for certain farms.

“We have heard the concern that these provisions, as proposed, would not fully achieve our goal of implementing the law in a way that improves public health protections while minimizing undue burden on farmers and other food producers,” Taylor said.

FDA plans to propose revised rule language by early summer 2014 and seek comment on it, “allowing the public the opportunity to provide input on our new thinking,” Taylor said.

But he added, “We will accept additional comments only on those sections of the proposed rules that have been revised. FDA remains under a court order regarding the timelines for finalizing these rules. FDA recognizes that completing these rules is essential to protecting the public health and is committed to completing them as quickly as possible.”

Taylor noted that FDA had held meetings around the country, but still there has been criticism that FDA has not sought comment widely enough.
Rep. Chellie Pingree, D-Maine

Rep. Chellie Pingree, D-Maine
Rep. Chellie Pingree, D-Maine, called the announcement “a major victory for farmers in Maine and across the country.”

“The one-size-fits-all approach the FDA was pursuing was overkill for thousands of small farmers and would have put many of them out of business,” Pingree said in a news release. “The size of the regulation just didn't match the size of the risk.”

Pingree said she’s reserving judgment until the new rules come out, but said the FDA’s announcement was a good sign.

She noted that she helped organized a public hearing in Augusta last summer in which more than 150 farmers and producers turned out to urge top FDA officials not to follow through with rules that would cripple smaller operations.
Sen. Jon Tester, D-Mont.

Sen. Jon Tester, D-Mont.
Sen. Jon Tester, D-Mont., also welcomed the FDA’s news.

“Small growers and producers selling straight to local consumers don’t require the same rules as large producers, and I’m glad the FDA is finally catching on,” Tester said in a news release. “I look forward to making sure the new rules better protect the small producers who feed our families and deserve better than one-size-fits-all regulations.”

The National Sustainable Agriculture Coalition praised FDA for announcing the new approach, but said there are other issues that need revision.

“For example, the on-farm co-management of conservation and food safety practices, including wildlife habitat protections, is a critical issue,” NSAC said.

“So too is defining farms to include usual and customary farming activities, as well as counting only regulated food and not all farm products in determining eligibility for modified requirements. Moreover, rules must be written and included in this second public comment period to clarify that direct marketing operations are not subject to food facility registration, a clarification Congress told FDA to make.”

The American Feed Industry Association said, “No rule is perfect, but AFIA acknowledges FDA’s intent to make these rules well suited for everyone involved in various industry segments. This is a positive sign for the future of FSMA. AFIA will continue to work hand-in-hand with FDA as we move forward in this process.”

The United Fresh Produce Association also applauded the announcement.

“We are encouraged that FDA took seriously the extensive input they received from produce farmers and others in the agricultural sector with respect to the proposed Produce Safety and Preventive Controls rules,” said David Gombas, senior vice president of food safety and technology.

“We appreciate FDA’s willingness to rethink these provisions and propose requirements that are more science and risk based. It is critical that FDA gets these FSMA rules right, and we believe this is a step in the right direction.”