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Small Food Producers Question Greater FDA Powers

New food safety legislation aimed at big producers will impose costly record-keeping and testing burdens on small farmers and food producers

By David E. Gumpert | Business Week

There's a big push in Washington to pass new food safety legislation. The House has already passed a major bill, the Food Safety Enhancement Act of 2009, which would significantly expand the Food & Drug Administration's authority to oversee food companies, and the Senate is expected to act on a similar version once its recess ends after Labor Day. President Barack Obama has indicated he will sign whatever the legislators finally approve.

The intensive action is coming in response to a number of highly publicized food recalls involving everything from peanut butter to spinach to cookie dough to raw hamburger over the last three years. The new law would seem to reduce the chances of food contamination by clamping down on producers—requiring detailed, written, quality plans, more frequent FDA inspections, and tough penalties for violations.

But when you speak with small producers such as Pascal Destandau, you have to wonder if the government is taking a sledgehammer to a porcelain cup. His Pugs Leap Farm in California's Sonoma County produces goat cheese as well as vegetables, fruit, and nuts. It grosses in the neighborhood of $100,000 a year selling at farmers' markets and to restaurants.

HACCP: onerous testing and paperwork?

Under the legislation, food producers large and small will be required to "implement a food safety plan," which is commonly understood to be a cumbersome process known as a Hazard Analysis and Critical Control Points plan for each food product they sell. Destandau worked for many years in a large pharmaceutical and personal care company—and knows much about HACCP plans.

"Creating one plan would take me about 100 hours and maintaining it would [mean] two hours per day of production. Based on quotes I obtained in 2006 for laboratory testing, I estimate that I would need to budget $15,000/year just for the microbiological testing of the cheeses."

That's before the plans for the veggies, fruits, and nuts. He and his partner already each "work 75 to 80 hours a week. HACCP would add a few more hours to each day," he says.

Simply ignoring the requirements and hoping regulators don't notice would be a risky proposition. "The FDA can fine you $10,000 per infraction per day," Destandau notes. Doreen Hannes, who with her husband runs a small farm in Mountain Grove, Mo., that derives about 40% of its income from rabbits it raises for meat and sells to a distributor in Arkansas, has similar worries. "We're going to get killed by (H.R.) 2749," she says. "We'd have more paperwork and less time to do our jobs."

The FDA wants "these critical tools"

A number of small-farm supporters are strenuously objecting to the legislation. "Small farms and local food processors are part of the solution to food safety, yet H.R. 2749 takes a one-size-fits-all approach, subjecting local producers to the same regulations as industrial firms," says Pete Kennedy, head of the Farm-to-Consumer Legal Defense Fund.

Asked for a response, an FDA spokesperson writes this email: "As a general matter, consumers should be able to expect that food is safe, no matter the size of the company making it. Preventive controls are the modern way to produce safe food. The bill provides different effective dates for its preventive controls provision for large, small, and very small firms (the bill leaves defining these terms up to FDA) of 18 months, two years, and three years. Extended compliance dates for small businesses is a common method to reduce the cost of compliance for small firms. General rulemaking requirements will also require FDA to consider the impact of its regulations on small businesses."

What also bothers business owners such as Destandau and Hannes is that not only have they not had any food safety problems, but they aren't averse to being held responsible for their products. "We want to be accountable," Hannes says, saying that she feels her business should be accountable to its distributors and consumers—rather than to government bureaucrats.

Government officials talk frequently about what Representative John Dingell (D-Mich.), sponsor of the House legislation, considers "the ongoing food safety crisis." According to FDA food safety adviser Taylor in recent testimony: "Every year, millions of our friends and neighbors in the United States suffer from foodborne illness, hundreds of thousands are hospitalized, and thousands die."

foodborne illness outbreaks declined

Yet data issued by the U.S. Centers for Disease Control suggests that the number of illnesses from foodborne pathogens has remained constant—if not declining. A search of the CDC's web site shows that for at least the last 10 years it has been estimating that 76 million Americans are sickened by foodborne illness each year. (The large estimate is based on the assumption that most foodborne illnesses aren't formally reported to public health authorities.) The CDC's tabulations of actual illnesses from outbreaks shows that in 2007, the most recent year for which it has data, there were a total of 21,183 suspected or confirmed illnesses from food outbreaks, down 25% from the 28,239 reported in 2004.

What also upsets many small food producers is what Doreen Hannes refers to as "the Big Brother" aspects of the new legislation. For example, the FDA will have authority under the legislation to inspect the business records of food producers at any time, free of the current limitation that requires a reasonable belief that adulterated food is being sold. According to the Farm-to-Consumer Legal Defense Fund, "FDA would now be empowered to go on a 'fishing expedition' and search records without any evidence whatsoever that there has been a violation."

In response, the FDA spokesperson explains: "Routine access to records is a critical element to the shift to a modern preventive controls system. Looking at records is how FDA inspectors will assess compliance with preventive controls requirements. This authority will not be used for 'fishing expeditions'."

For Destandau, the latest federal efforts to crack down on food producers is part of a long-term trend. When he started in business in 2003, he had one inspector to deal with, from the California Food & Agriculture Dept. Now he deals with more frequent and costlier inspections from both the CDFA and the county health department. As Destandau contemplates the addition of FDA inspectors, he considers leaving the U.S. entirely. "Right now, we are seriously looking at moving to Australia," he says.

David Gumpert is a journalist who blogs regularly about the business of health and has written a number of books about small business and entrepreneurship, including "Burn Your Business Plan!" His new book, "The Raw Milk Revolution," is due out in November.

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