Organic Pastures, the nation’s largest raw milk dairy, has launched a lawsuit against the U.S. Food and Drug Administration for allegedly turning its back on the dairy’s request for the agency to change its current law banning sales of raw milk across state lines.
Raw milk is milk that hasn’t been pasteurized to kill potentially harmful, and at times deadly, pathogens such as E. coli, Listeria, Salmonella and Campylobacter, all of which have been been linked to raw milk food poisoning outbreaks in a number of states across the nation.
The Fresno-based dairy submitted its request to the agency back in December 2008. According to statute, the FDA is supposed to respond to this sort of request — referred to by the agency as a “citizen petition” — in 180 days. The FDA promotes this administrative procedure as a way to examine issues such as this to see if changes should be made.
In a similar lawsuit filed last year by the Farm-to-Consumer Legal Defense Fund, which focused on the agency’s ban on interstate sales of raw milk, FDA faulted the defense fund for bypassing this administrative procedure. It told the court that filing a citizen petition allows the FDA “to consider and address plaintiffs’ concerns and could potentially resolve those concerns, or at the very least might crystalize the issues in contention.” The federal court dismissed the case in April 2012.
Time to Get On with It
Organic Pastures’ lawsuit against the FDA was filed on Dec. 12, 2012 in U.S. District Court in the Eastern District of California. It names Secretary of Health and Human Services Kathleen Sebelius and U.S. Food and Drug Administration Commissioner Margaret Hamburg – as well as the agencies they head – as defendants.
As far as the dairy’s owner, Mark McAfee, is concerned, it’s high time for the feds to stop dragging their bureaucratic heels on this issue.
McAfee told Food Safety News that the agency did send him a notice 90 days after he sent the request (citizen petition) in 2008, but it was just to let him know that it had received it. And that was it, said McAfee. But after some recent prodding on his behalf by Gary Cox, general counsel for the Farm-to-Consumer Legal Defense Fund, the FDA said they were “working on it,” but that it wasn’t a priority. McAfee said that was about six months ago and that nothing has happened since.
“The time is ripe now,” he said, referring to increasing consumer demand for raw milk and why he wants some action on his request.
Pure and simple, said McAfee, all that Organic Pastures is asking for is that the agency promptly come up with a ruling on the petition. As part of the legal action, the dairy is also seeking to recover legal fees.
McAfee said he would like the current ban against interstate sales of raw milk for human consumption, which was adopted in 1987, to be changed so that raw milk that is produced legally in one state can be shipped across state lines to another state that also allows sales of raw milk. California and Arizona, both of which allow sales of raw milk for human consumption, would be an example of states that would participate in this sort of interstate commerce.
In McAfee’s case, demand for raw milk in nearby Arizona is driving his interest in seeing the ban on interstate sales lifted. He said that with about two raw milk dairies in Arizona, the state is “really short of raw milk.”
As an example of that, Sprouts stores, a retail chain that sells Organic Pastures’ milk in its California stores, is hearing from its stores in Arizona that their customers are clamoring for raw milk. That same growing demand is being seen in many other parts of the nation.
According to the FDA, 20 states explicitly prohibit sales of raw milk in one form or another and 30 allow it. Among the states that allow it, California, Arizona, Maine, New Hampshire, Nevada, Pennsylvania, Utah and Washington state currently have very strict standards for the milk’s cleanliness. Bottom line, they have a coliform standard (amount of bacteria in the milk) of no more than 10 coliform bacteria per milliliter and no pathogens. This standard is equivalent to the national and some international standards for pasteurized milk.
FDA does not interfere with state laws regarding intrastate sales (sales within states) of raw milk.
McAfee was quick to say that he’s not asking for raw milk to be allowed across every state line in all cases because “sloppily produced raw milk can be dangerous.” He even goes so far as to say that he thinks there should be some universal standards for raw milk.
“It’s about food safety standards and good practices,” he said. “I’m a big advocate for food safety planning. It orients the farmers’ mind to the way things need to be done to produce safe milk.”
Bringing Down the Wall
McAfee sees his latest legal action against the FDA as an attack on what he refers to as “the Berlin Wall — a wall that’s separating farmers from consumers.”
“Once you take one brick out of the wall, the wall weakens, and there’s a better chance of bringing it down,” he said. “I want to tear down the wall.”
But he’s actually looking farther afield than this lawsuit. If the agency doesn’t give him what he’s looking for when it responds to his request, he wants to press for a full-on jury trial.
“I want to bring in the experts to talk about this,” he said, referring to pasteurized milk as “the most allergenic food in America.” In contrast, he said, raw milk has important nutrients in it such as enzymes that kids need to be able to digest milk.
But when asked how far raw milk should be allowed to be shipped as part of interstate commerce, McAfee said he believes raw milk should be a local product available to consumers not too far from its source.
Organic Pastures, which is milking 450 cows on 500 acres of pasture, currently has 75,000 customers — up from 65,000 customers several years ago. Four hundred stores sell the dairy’s raw milk and raw-milk products.
“Every month we set new records,” McAfee said. “We’re almost at $10 million in annual sales right now.”
Yet even with California’s strict raw milk standards, harmful bacteria can get into the milk. This year in May, for example, the state ordered a recall and slapped a statewide quarantine on Organic Pastures’ raw-milk products (except for its cheeses) after inspectors confirmed the detection of Campylobacter bacteria in the dairy’s raw cream.
According to the state’s Public Health Department, at least 10 people who came down with Campylobacter from January through April 30 reported drinking Organic Pastures raw milk before becoming ill. The age range in that outbreak was from 9 months to 38 years, with six of the infected people under 18. None of the patients were hospitalized, and there were no deaths.
Then in September, state officials once again detected campylobacter in Organic Pastures’ raw cream samples. As a precautionary measure, the dairy also recalled its raw whole milk and raw skim milk even though they tested negative for Campylobacter. No illnesses were reported at that time.
In November 2011, a cluster of five young children infected with the potentially fatal E. coli O157:H7 reported drinking milk from Organic Pastures. In that outbreak, which was linked to the dairy by “genetic fingerprint patterns” of the E. coli the children were infected with and “genetic fingerprint patterns” found in samples collected at the dairy, led the state to issue a recall and quarantine of the dairy’s milk products (except for its cheeses).
The dairy has also been been involved in recalls and outbreaks in the past.
When asked about this, McAfee readily conceded that there’s still a lot to be learned about bacteria.
“The entire thing (producing raw milk) is a learning process,” he said. “No one completely understands bacteria and how they interplay with humans. But in the past 13 years, we’ve learned a lot. And as we tighten up our food-safety practices, we’re seeing problems with pathogens shrink. I think you’ll see more research being done to make raw milk more dependably safe.”
An Evolving Scene
As an example of how the production of raw milk is evolving, McAfee pointed to a recently developed test that will rapidly detect pathogens in raw milk.
“But it’s not available yet,” McAfee said. “We (raw-milk producers) are still a little behind the curve in getting the research money for this.”
Even so, he said he’s seeing the attitude toward raw milk within the conventional milk industry changing from outright antagonistic to neutral or even supportive.
“Even our governor (Jerry Brown) drinks raw milk,” McAfee said. “We’ve definitely seen a change in attitudes about raw milk in the past three years.”
FDA’s Enforcement Strategy
The FDA on Nov. 1, 2011 issued a press release reminding people of its approach to enforcement when it comes to individuals taking legally produced raw milk for their own consumption across state lines.
“FDA has never taken, nor does it intend to take, enforcement action against an individual who purchased and transported raw milk across state lines solely for his or her own personal consumption,” says the press release.
Even so, in the same press release the agency points out that since 1987 (through Nov. 2011), there had been 143 reported outbreaks of illness — some involving miscarriages, still births, kidney failure and deaths — associated with consumption of raw milk and raw milk products.
The press release also says that while raw milk puts all consumers at risk, it is the elderly, the immune-compromised, children and pregnant woman who are especially vulnerable to the hazards of consuming raw milk.
For the FDA, pasteurization of milk, which was adopted decades ago as a public health measure to kill dangerous bacteria and for the most part eliminate the risk of getting sick from drinking milk, was an important step because milk is one of the most important staples of the American diet.
And though raw milk advocates point to a range of health benefits such as curing asthma and immune-related problems, the FDA warns that those claims have not been scientifically substantiated and that the health risks associated with drinking raw milk are clear.
The agency’s position on raw milk lines up with the positions taken by the Centers for Disease Control and the American Academy of Pediatricians.
Go here for more information about raw milk. The site also provides information about outbreaks and illnesses from raw and pasteurized milk and dairy products from 1998 to the present.© Food Safety News