FDA answers questions about produce safety rule in Wooster


WOOSTER, Ohio — One by one, produce growers and industry representatives approached a panel of Food and Drug Administration staff Tuesday afternoon with questions about new rules coming their way.

About a third of the FDA’s public listening session, held at the Ohio Agricultural Research and Development Center, was devoted to question and answer, following opening comments by FDA staff and Ohio’s Agriculture Director David Daniels.

The new rule will meet the requirements of the broad-sweeping Food Safety Modernization Act, signed into law Jan. 4, 2011. It will make many of the current Good Agricultural Practices used on produce farms into enforceable standards.

Questions included guidelines for applying manure, who is exempt from the rule, what will it cost, when will it take effect and how will it be enforced.


Michael Taylor, deputy commissioner for foods at FDA, said the rule “is for the first time setting enforceable standards for practices on farms that can affect the safety of produce.”

Many of the practices are already being followed, several producers said, but the rule will make the standards a requirement.

Taylor and others who spoke said the focus is on setting standards that work for producers, as well as consumers.

“The first principal in all of this is that we have to confirm and rely upon the primary role that you, the people that produce food, play,” he said. “This is the frontline of food safety.”

Samir Assar, director of food safety staff at FDA, said there will be a strong focus on educating growers how to comply, including the formation of a technical assistance network on produce safety.

FDA has produced multiple public summaries of the legislation, which growers said will be useful as they review what all is included. The policy broadly covers standards for all aspects of unprocessed fruits and vegetables sold off a farm. It covers such specifics as agricultural water, biological soil amendments of animal origin, health and hygiene, animals in the growing area and equipment, tools and buildings.

Several Amish growers attended the listening session, one who said producers should be educated at the simplest level possible. He reminded FDA that many of the Amish growers have only an eighth-grade education.

“I always was able to accomplish more in the form of education than in the form of regulation,” said Raymond Yoder, of Yoder’s Produce Supply in Fredericksburg.

Who it covers

The proposed rule does not treat all producers the same. Farmers who grow produce for use on their own farm would be exempt, as well as those who grow and sell less than $25,000 in food annually from their farm.

Taylor said the exemption was heavily debated, but officials ultimately decided it would not be economically feasible to enforce the standard on the very smallest of producers.

Producers who sell up to $250,000 of food products a year would be considered a “Very Small Business.” These farms would have four years after the rule’s effective date to comply; for some of the water requirements, they would have six years.

Producers whose sales range from $250,000-$500,000 would be considered a “Small Business.” These farms would have three years after the effective date to comply; for some of the water requirements, they would have five years.

Manure application

Multiple farmers asked about the rule’s standard for raw manure application, which requires a nine-month minimum waiting period before harvest, if the manure is applied in a way that it comes into contact with the produce plants.

The National Organic Program sets the standard at just 120 days — a much shorter period. But FDA officials said they did not have sufficient science that the 120-day period was enough time.

However, farmers were told they could apply manure whenever they wanted and till it into the ground, or avoid contact with produce plants, essentially with a zero-day wait.

Animals for work

Several farmers asked about using horses and other animals in the growing area.

Joy Johanson, another FDA panelist, said the main thing is that the worker “minimize direct contact with covered produce while they’re working with the animal.”

Stark County produce grower Alex Dragovich specifically asked, “You are in no way going to eliminate us from the use of horses, correct?

Assar assured him, “We are not putting forth requirements that would forbid the use of animals.”

What will it cost?

The exact cost is not yet known, but would depend in part on what practices the farm already is following. If a produce safety plan already is in place, and the equipment and facility are in good repair, the burden of meeting the new rule would be lessened.

Two or three organic farmers said they thought the rules might be cost-prohibitive, and they testified that the new rules might put them out of business.

“If the FDA does not address the cost concerns of the proposed rule, many farmers may risk … going out of business,” said MacKenzie Bailey, a spokesperson for the Ohio Ecological Food and Farm Association.

But Yoder, who has worked cooperatively with FDA throughout the process and invited them to his farm, said most of what they want farmers to do is common sense — something they can afford.

“If they (farmers) tried to use common sense, it won’t put them out of business,” he said.

To comment

You can comment on the rule electronically at the Federal Register website. You can fax your comments to the FDA at 301-827-6870, or by mail at Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, MD 20852.


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