FDA Denies Petition to Lift Interstate Ban on Raw Butter

As expected, the U.S. Food and Drug Administration has denied a citizen petition from the Farm-to-Consumer Legal Defense Fund (FTCLDF) and Organic Pastures Dairy Company (OPDC) to lift a ban on the interstate distribution and sale of raw butter.

In a February 27 letter to FTCLDF and OPDC, Mark Moorman, Director of FDA’s Office of Food Safety and Applied Nutrition, stated: “Your Petition does not contain facts demonstrating reasonable grounds…to allow the interstate delivery or sale or distribution of raw cream butter. Further, your petition does not substantially show that your proposal is in the public interest and will promote the public health objectives of FDA and the statutes we administer….”

Allowing access to a nutritious raw dairy product like butter is not a “public health objective” of FDA.

While FDA’s decision wasn’t a surprise, the weakness of its response to the petition was. At the end of the FDA letter was a five-page table on “Illnesses and deaths associated with butter not known to be pasteurized, (1908 to 2003).” There were 13 outbreaks during that 95-year timeframe attributed to raw butter consumption, with one of the outbreaks occurring in England.

Of those 13 outbreaks, all but one described the butter as “Not Specified but commonly unpasteurized” or “Not Specified.” The one entry listed as “Unpasteurized” is a 2001-2002 outbreak where 202 people in North Carolina allegedly became ill from butter. This entry is different from the CDC’s foodborne illness outbreak database, which attributes the illnesses to “other milk, unpasteurized”. According to published articles, homemade butter was served to elementary school students as part of a demonstration.

Seven of the 13 outbreaks fail to specify the “Total Number of Illnesses”; one shows “reports of consumer injuries” while six show “NA” (meaning, “Not Available / Not Reported”). One of the entries, a 1991 outbreak where 265 people became ill in California and Nevada, lists the implicated food as “blended butter and margarine products”. How often has raw butter been blended with margarine — ever?

Two of the 13 outbreaks indicate that someone was hospitalized — one person in one case, four in the other. The remainder indicate that no data is available. Only one of the 13 outbreaks specified whether there were any deaths (i.e., six in a 1913 Minnesota outbreak). Again, the remainder indicated that no data is available.

If a petitioner had submitted a graphic to FDA with data this incomplete, the agency would have rejected it out of hand. Even if FDA is correct on the number of outbreaks attributed to raw butter consumption, the total amounts to one outbreak every seven or eight years. If that is the standard for banning a food in interstate commerce, many foods would be illegal.

Much of FDA’s response consisted of disagreeing with the petitioners’ interpretation of various studies regarding butter and pathogenic bacteria, as well as citing challenge tests (such as studies in which butter is inoculated with pathogens, then observed to monitor what happens). Shouldn’t the ultimate determining factor be, from a scientific standpoint, how many people have gotten sick from consuming a food?

The CDC database on foodborne illness outbreaks from 1998-2016 that FTCLDF and OPDC used in their petition to FDA doesn’t blame a single outbreak on commercially produced raw butter, and only one outbreak is blamed on homemade raw butter [Utah in 2007].

FDA tried to downplay raw butter’s impressive safety track record by pointing to the 1987 interstate ban as the reason there have been almost no outbreaks. However, raw butter sales have been legal in California since the state’s inception. Mark McAfee, OPDC’s president, stated that his company has sold well over 2 million lbs. of raw butter the past 20 years without illness. About 10 other states allow the sale or distribution of raw butter.

Aside from the small number of foodborne illness outbreaks attributed legitimately or otherwise to raw butter consumption over the past 112 years, the FDA denial of the petition could be vulnerable to a court challenge in other areas.

The butter ban is illegal according to a statute (21 USC 341) in the Federal Food, Drug and Cosmetic Act that governs “standard of identity” for food which are requirements prescribing what a food product must contain to be marketed under a certain product name in interstate commerce. For instance, the standard of identity for milk requires that it be pasteurized or ultra-pasteurized and that it contain not less than 3-¼ percent milkfat [21 CFR 131.110]. The citizen petition notes that FDA addressed the question of requiring pasteurization as part of a standard of identity regarding milk and found that such health-based requirements were properly addressed as standards of identity stating: “The Commissioner rejects the contention that section 401 of the act does not permit provisions of a standard of identity to be promulgated for health reasons. [39 Fed. Reg. 42,351 (Dec. 5, 1974)]”

Congress has given FDA power to establish standard of identity requirements for most foods but specifically prohibits the agency from doing so for butter. In its response FDA justified its violation of the standard of identity by claiming the Public Health Service Act gives it authority to require pasteurization for butter as part of its power to regulate communicable disease, a stretch given the food safety track record of raw butter. FDA, in its response, argued that standard of identity was about protecting consumers against economic adulteration and reflecting consumer expectations about food, contradicting its earlier statement that health reasons can also be a factor in these regulations.

A second area where FDA is on weak ground is that, in the lawsuit that resulted in the court order to FDA to impose the ban [Public Citizen v. Heckler, 653 F. Supp. 1229 (D.C. District, 1987)], butter is not mentioned at all in the court record of the case. Butter, like cheese, is considered a manufactured milk product. The lawsuit sought the ban of all raw milk and raw milk products in interstate commerce. The definition of “milk products” in the FDA Pasteurized Milk Ordinance (PMO)–the governing document for the production and distribution of milk and milk products in interstate commerce–does not include butter or cheese.

The court record only discussed dairy products that were listed in the PMO definition of “milk product.” When the court ordered FDA to ban “raw milk’ and ‘raw milk products’, it was only those products under that definition. In its response, FDA claimed the court order banned all products made from raw milk but, if the agency is correct in its interpretation, aged raw milk cheeses wouldn’t be legal in the U.S. as they have always been. The impetus for the litigation that resulted in the court order was the lack of FDA enforcement on standard of identity regulations requiring pasteurization for milk and various milk products–because of the statutory prohibition, there is no standard of identity regulation for butter.

Farm-to-Consumer Legal Defense Fund (FTCLDF) is appealing the FDA denial to the federal district in court in the District of Columbia. The appeal to challenge FDA is likely to be costly as it will require paying scientific experts as well as attorneys. FTCLDF could really use your financial support. Overturning the butter ban is a big step toward a day when all raw dairy products will be legal in interstate commerce.

To donate specifically to support the case to overturn the FDA decision, you may donate online or call 703-208-3276.

Shortlinks: citizen petition – https://wp.me/a44gEP-2vE FDA response – https://wp.me/a44gEP-2vD

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