Washington Week Ahead: Produce standards, import regulations set for FDA release

By Philip Brasher

© Copyright Agri-Pulse Communications, Inc.



WASHINGTON, Nov. 8, 2015 - The Food and Drug Administration is expected to roll out a set of landmark rules this week that includes the first federal safety regulations for how fresh produce is grown and packed.

The new rules also will include foreign-supplier verification regulations aimed at improving the safety of all imported foods.

The rules were required under the Food Safety Modernization Act, which was enacted nearly five years ago in the wake of a series of deadly, nationwide outbreaks traced to produce and peanut butter.

Sandra Eskin, director of food safety at The Pew Charitable Trusts, said FDA's produce rule “is a game changer” that will have its biggest impact on medium and smaller size producers who haven't had to comply with industry standards that wholesalers and retailers impose on the largest growers and packers.

“The challenge for FDA is to make sure that people on the ground … understand what they need to do,” she said.

The House is in recess this week, and the Senate has an abbreviated schedule because of Veterans Day, Nov. 11. But congressional appropriators and their staff are at work on a government-wide fiscal 2016 spending bill, and leaders of the Senate Agriculture Committee are trying to wrap up negotiations on reauthorization of child nutrition programs.

< Together we can feed the Bees" p>Senate Agriculture Chairman Pat Roberts, R-Kan., wants to have the deal done before the Thanksgiving recess. “We're trying to get a bipartisan, budget-neutral agreement to move forward. … We're very close. I think we're going to get an agreement,” he said in an Agri-Pulse Open Mic interview.

“We need to protect the tremendous gains already achieved by many school districts that are doing a good job and provide assistance to others so that they can achieve that kind of success.”

State regulators appeal for FDA funding

The big question for FDA as it releases the new FSMA rules is how much money it will have to pay for funding the training of state regulators, farmers and others. Much of the enforcement responsibility will fall on states.

Groups representing states and local governments have appealed to the House and Senate Appropriations committees to provide FDA with the full $109.5 million funding increase that the White House requested for fiscal 2016.

“Delay in funding these important capacity investments will hamper our efforts to prepare for these new responsibilities and communicate regulatory certainty to the agricultural operators and food processors who already know and rely on state, local and tribal food safety agencies and educators,” according to a Nov. 5 letter signed by groups including the Association of Food and Drug Officials, Association of State and Territorial Health Officials and the National Association of State Departments of Agriculture.

“It is very important that FSMA not become an unfunded federal mandate to governments and educators already burdened with challenging fiscal environments and highly diverse regulatory and public safety responsibilities.”

The Senate's 2016 Agriculture appropriations bill provide an extra $45 million for FSMA implementation. The House version contains $41.5 million.

FDA said it needed $50 million for implementing the produce rule in 2016 and another $50 million for preventive control rules issued in September for food processors and feed manufacturers. The rest of the requested money is earmarked for increasing oversight of imports

Growers across the industry were sharply critical of the produce rule as FDA originally proposed it in 2013, but the agency significantly revised the regulations last year to address a variety of grower concerns, including that the restrictions were excessive on irrigation water and the use of manure as fertilizer.

The revised rule reduced the frequency of required water tests and would permit farmers to use water that exceeds microbial limits as long as they allow enough time before harvest for the pathogens to die off, the National Sustainable Agriculture Coalition noted in a recent analysis.

FDA also relaxed a proposed standard for how long manure had to be composted before it could be applied, and the agency decided that small farms that lost their exemption from the regulations if an outbreak was traced to their products could apply for reinstatement later.

A report released last week by the Centers for Disease Control and Prevention underscored the challenge facing FDA as it finalizes the new rules. FDA regulates about 80 percent of the food supply, or virtually everything except meat and poultry.

The CDC said multistate outbreaks of food-borne illnesses account for more than half of all deaths due to food-borne illnesses although they're responsible for only 3 percent of total outbreaks. The foods most implicated in the multistate outbreaks: fruits, vegetable row crops, beef and sprouts.


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Also this week, Friday is the deadline to respond with data and information relevant to the Obama administration's long-range review of the federal regulatory process for agricultural biotechnology.

The agencies are asking what biotech products should be regulated by which agency and what relevant data and information, including case studies, that the agencies need in the review.

USDA, EPA and FDA held their first public meeting on the review Oct. 31. The National Grain and Feed Association and the North American Export Grain Association urged the agencies to expand the review to ensure that the U.S. regulatory process is coordinated with foreign agencies so as to facilitate biotech trade.

Here's a list of agriculture- or rural-related events scheduled for this week in Washington and elsewhere:

Monday, Nov. 9

4 p.m. - USDA releases weekly Crop Progress report.

Tuesday, Nov. 10

Fourth Republican presidential debate, Milwaukee.

9 a.m. - Farm Foundation forum on how the sage grouse conservation plan and similar public-private efforts will shape future efforts to preserve species and enforcement of the Endangered Species Act, National Press Club.

9:45 a.m. Senate Foreign Relations Committee considers nomination of Linda Etim to be an assistant administrator of the Agency for International Development, 419 Dirksen.

Noon - USDA releases monthly Crop Production report and World Agricultural Supply and Demand Estimates.

Wednesday, Nov. 11

Veterans Day

Thursday, Nov. 12

10:30 a.m. - Forum sponsored by Foodtank on “The Real Cost of Food,” Founders Room, American University.

Friday, Nov. 13

Comment deadline on review of the Coordinated Framework for the Regulation of Biotechnology.

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