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With a long list and short on money, FDA tackles food safety

This summer there has been a drumbeat of food-related illnesses. Strawberries containing E. coli killed one person in Oregon and sickened at least nine others. Ground turkey contaminated with salmonella poisoned more than 100 people nationwide, with one dead, and prompted one of the largest meat recalls ever. Imported papayas tainted with salmonella sickened at least 99. Sprouts grown in Idaho were linked to salmonella illnesses in five states.

The landmark food safety law passed by Congress in December is supposed to reduce the frequency and severity of food safety problems, but the roll call of recent cases underlines the magnitude of the task.

“It’s an enormous undertaking,” said Mike Taylor, the Food and Drug Administration’s deputy commissioner for foods, whose job it is to turn the far-reaching law into a coherent set of rules that farmers, food processors and importers can follow and regulators can enforce.

The agency is taking on the expanded mission at a time when Washington budget-slashing means that regulators have little hope of getting additional money and may instead have their budgets cut by Congress.

“We have to have the resources to implement this law,” Taylor said. “The stark choice is we either find the resources or we forgo implementing this law the way Congress intended. You can’t build something brand-new without the resources to do it.”

The agency is in the process of writing the food safety rules called for by the law, with the goal of preventing outbreaks like those this summer. (The nation’s meat and poultry supply was already regulated by the Agriculture Department and is unaffected by the new law.)

One of the most complex jobs involves setting standards for farmers to grow and harvest fruits and vegetables safely. The first draft of the farm rules is due early next year. The agency has not said what they will include, but they are expected to deal with basics like hand-washing stations for field workers, tests of irrigation water and measures to protect fields from wild animals that can track in bacteria.

Investigators in Oregon say they believe that deer may have brought E. coli into the strawberry fields there, so such federal rules could potentially help prevent future outbreaks of that kind.

Yet the standards must take into account a huge variety of crops, farming practices and farm sizes. The task is all the more delicate because the agency has never before had a major presence on American farms.

For a year and a half, well before Congress passed the food safety law, Taylor has been on a listening tour, visiting farmers around the country and seeking to allay their fears that an army of food safety bureaucrats will come storming through their fields telling them how to do their jobs.

Recently, he visited Long Island, where he tramped through the sandy fields of the 30-acre Deer Run lettuce farm of Bob Nolan in Brookhaven.

Nolan said he was initially anxious about the new law but was now eager to help the agency make it work for farmers. Taylor was joined by several agency employees involved in writing the farm rules, and Nolan told them he hoped the visit would help them better understand how a farm worked.

He went over steps he had taken to improve food safety, including creating a tracking system that linked every head of lettuce he sold to the section of field where it was grown and doing yearly tests of irrigation water for dangerous bacteria. And he asked for clear guidance in the rules for techniques like how to safely use composted horse manure to fertilize his fields.

The complexity of the FDA’s task became clear as the day went on. At the second stop, a potato farm in Riverhead, the owner, Jimmy Zilnicki, said he knew little about what the government expected of him.

“We’re all just trying to find out what this food safety thing is all about,” he said. Besides, he argued, potatoes were a safe crop and he questioned whether it was worth including them in food safety rules.

Taylor told him that the FDA’s job was to focus most of its efforts where the food safety risks were greatest.

The third stop was a 65-acre organic farm in Riverhead, run by Eve Kaplan-Walbrecht and her husband, Chris. They grow a dizzying array of crops, from arugula to zucchini, most of which they sell directly to customers through farmers’ markets and buying clubs.

They, too, had made costly improvements with an eye toward food safety, including building a large processing shed with a concrete floor, treated water, a bathroom and refrigerated storage. The new law exempts small farms that average less than $500,000 a year in sales and sell mostly to local customers. But Eve Kaplan-Walbrecht said that her farm, known as Garden of Eve, brings in too much money to qualify for the exemption.

She worried that the new law could become a burden for small farmers, either by adding paperwork or by unleashing regulators with little understanding of how a farm worked.

“If you’re going to be in fear that someone’s going to show up and there’s going to be a rabbit in your carrot patch and you’re going to get in trouble, then that’s a problem,” she said.

But while farmers worry that the rules will be too stringent, food safety advocates worry that budget cuts could render the law toothless.

The Congressional Budget Office has said the FDA will need hundreds of millions of dollars in new financing to execute the law, and there appears little chance that Taylor will get it.

The Republican-controlled House of Representatives has passed an appropriations bill that largely eliminates new money for the FDA. The Democrat-controlled Senate has not made its own proposal. But advocates fear that the new congressional supercommittee that is to propose cuts under the debt ceiling deal could further pare the agency’s finances.

A budget freeze or cuts would have the greatest impact on the ambitious increase in inspections called for under the new law, which ramp up each year.

“Writing rules is inexpensive; enforcing them is expensive,” said David W. Acheson, a former associate commissioner of the FDA who is now a food safety consultant. “There will be a public health impact because enforcement won’t be to the extent they want to do it.”

The agency has said that, without lots of new money, it won’t be able to conduct the thousands of foreign food inspections the law would require after a few years. Increasing domestic inspections would be difficult, too. The FDA has about 1,000 inspectors trained to visit food establishments but most of them also inspect drug and medical device facilities. Hiring new inspectors or retraining existing ones is costly.

So far, Taylor has won praise for the introduction of the new law. A lawyer and long-time official at the FDA and the Agriculture Department, he headed the USDA’s food safety office in 1994 when the agency declared it illegal to sell ground beef containing a toxic form of E. coli bacteria, a move that was fiercely opposed by the meat industry. He has also worked in the private sector, most recently as a vice president of public policy for Monsanto, the agricultural chemical and biotech company.

“I’ve never seen the agency go at anything with such enthusiasm,” said Carol L. Tucker Foreman, a food policy expert at the Consumer Federation of America. But she feared that without a higher budget, the agency would take shortcuts. The law requires the most frequent inspections at the riskiest facilities, and Tucker Foreman questioned whether the agency would simply classify fewer operations as high risk to make its job easier.

Taylor said that would not happen. “We’re not going to game the system,” he said.

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