FDA ramps up scrutiny on a new area: Cheese
By Lyndsey Layton,
In a filing in federal court two weeks ago, the U.S. attorney in Sacramento named as the defendant 97 wedges of Gouda cheese. The co-defendant was 14 blocks of white cheddar, including the sage, white pepper and onion varieties.
It was an apt, if odd, quirk in an arcane legal process, as the government took steps to seize the cheese - 40 tons of it. The Gouda and cheddar were made by Bravo Farms, a small artisanal cheesemaker whose award-winning morsels were linked to an outbreak of E. coli O157:H7 illness that sickened at least 38 people. By invoking civil forfeiture law, the government could take immediate possession of the suspect cheese and prevent it from entering the food supply.
Cheese, it turns out, has been on the defensive increasingly over the past year, as federal regulators rachet up their scrutiny of a growing segment of the food business: artisanal cheesemakers.
Since April, the Food and Drug Administration has increased inspections of cheesemaking facilities, launched a review of its regulations and been reassessing the health risks posed by specialty cheeses.
Regulators say they are trying to prevent and reduce serious illnesses caused by contaminated cheese. Over the past five years, according to the FDA, outbreaks involving raw-milk cheese made more than 400 people ill, leading to 87 hospitalizations, a stillbirth and two miscarriages.
"The primary message is that food has to be made safely, no matter where it's made," said Donald Kraemer, deputy director at the FDA's Center for Food Safety and Applied Nutrition. "We don't expect the small artisan cheese manufacturer to look like a Kraft facility. But the fundamental things which make food safe must be in place."
But artisanal cheesemakers, and their boosters in the local-food movement, say they are being unfairly targeted. They say the FDA does not understand their craft and is trying to impose standards better suited for industrial food companies.
Taste vs. safety
The conflict is emerging particularly around cheese made from raw milk, especially soft cheeses - the kind that have inspired devotion from foodies and can garner $27 a pound in high-end markets.
"There's extra depth of complexity in raw cheeses, particularly soft ripened cheeses," said Roy Breiman, a chef and culinary director at Cedarbrook Lodge in Seattle, who uses artisanal cheeses on his menu. "Watch the flavor on the palate and you get all the different nuances, from fruits to nuts to grass to milk." By contrast, most cheese made from pasteurized milk tastes dull, he said.
Artisanal cheesemakers make their products by hand in small batches, following practices hundreds of years old. Many raise the cows or goats that produce the milk for the cheese, overseeing every step from raw ingredient to finished product.
But because cheese made from raw milk is not heated, regulators worry that the lack of a "kill step" means greater risk of contamination from pathogens that can cause illness.
To address that, federal law requires cheese made from raw milk to be aged for at least 60 days. The theory is that two months is long enough for the acids and salts in the cheese to kill off harmful bacteria such as listeria, salmonella and E. coli.
But that standard was set in 1949, and research in the mid-1990s found that listeria and other bacteria can survive in cheese beyond 60 days.
As part of its new emphasis on cheese safety, the FDA is reexamining its rules on raw-milk cheese and is likely to propose changes within the next several months, Kraemer said.
Although no one keeps exact statistics, estimates put the number of artisanal cheesemakers in the United States at roughly 450, and their ranks are growing, said Heather Paxson, an associate professor of anthropology at MIT, who is writing a book on the subject. The business dates to the late 1970s, launched by hippies, dairy farmers chasing supplemental income and well-heeled professionals seeking a back-to-the-land second career, Paxson said. Many are in rural areas of Washington state, California, Vermont, Wisconsin and New York.
The FDA sees greater food-safety risks when food is made on a farm.
"There's no question there are more challenges," Kraemer said. "The employees are the same ones who are milking the cows. Ensuring there is a separation from inherently dirty operations is a challenge."
Inspections ramp up
Since April, the agency has inspected 120 cheesemaking firms, large and small, and found that one-quarter were contaminated with listeria monocytogenes, bacteria that can cause serious illness in the elderly, children, pregnant women or those with compromised immune systems. The agency did not report whether the contamination was more common among the artisanal operations.
Listeria is ubiquitous in the environment, but the FDA has a zero-tolerance rule for it in ready-to-eat food such as cheese. If the bacteria are present, the food is considered adulterated and cannot be sold. Some countries, including cheese-loving France, tolerate minute amounts of listeria in food.
The attention from regulators has unsettled small cheesemakers. The American Cheese Society, a trade group, surveyed its members recently, and 74 percent of the respondents reported that they had been inspected by the FDA in 2010, compared with 8 percent in 2009. Next week, the group is holding its first Internet seminar for cheesemakers on food safety.
"Everybody's bottom line is that we want safe food," said Christine Hyatt, president of the board at the cheese society. "However, we need to support this fledgling industry that's providing a product that people are just loving. Cheese can be more than a sliced single."
Family farm in spotlight
Many of those who see an unjust federal crackdown have made a cause celebre of the Estrella Family Creamery, a small family dairy in Montesano, Wash., that makes about 20 cheeses from raw cow's and goat's milk.
A year ago, state inspectors detected listeria in the dairy's cheese and its facility. Kelli Estrella and her husband, Anthony, recalled some products and cleaned their operation. But by August, FDA inspectors had visited the operation and found the same strain of listeria in the cheese.
The FDA, which had no authority at the time to force a recall, asked the Estrellas to voluntarily pull their products from the market.
Kelli Estrella refused. She said that listeria had been confirmed only in her soft cheeses, that no illnesses had been reported and that her hard cheeses were safe. "I've got long-aged cheeses, and they never tested positive" for bacteria, she said. "To make us throw it all away, without any valid proof at all, without any illnesses, is just wrong."
In October, the FDA got a court order to seize all the Estrella cheese, which is now impounded at the family creamery. The company's operations have been idled; it cannot resume cheesemaking without approval from the FDA.
Other farmers have been donating feed for the Estrellas' cows and goats, and friends launched a Web site - "Help the Estrella Family Creamery" - to collect contributions.
Kelli Estrella said the FDA sent her a 21-page document outlining changes she must make before she can resume making cheese. "They're treating us as if we were Kraft," she said.
The FDA declined to discuss the Estrella case because it is ongoing.
William Marler, a Seattle attorney for 11 people sickened by Bravo Farms cheese, said the government is not singling out small cheesemakers. "The FDA isn't beating up on artisanal cheesemakers," he said. "It's doing its job, which is to protect public health."
Bravo Farms has been cooperating with federal officials. The cheese seized by regulators sits in storage in Bravo's aging caves, under the control of the federal government. Microbial testing has not identified the source of the E. coli contamination, said Robert Nelms, an attorney for the company.
"We believe the facility always meets or exceeds the standards for production," Nelms said.
With approval from the FDA, Bravo resumed making cheese. But it is using only pasteurized milk.