Page 99 - Spring2020

RAW MILK UPDATES by Pete Kennedy, Esq.

FEDERAL: FDA DENIES RAW BUTTER PETITION
As expected, the U.S. Food and Drug Administration (FDA) 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 the 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 thirteen outbreaks during that ninety-five-year timeframe attributed to raw butter consumption,
with one of the outbreaks occurring in England.
Of those thirteen 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 two hundred two people
in North Carolina allegedly became ill from butter. This entry conflicts with 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 thirteen outbreaks fail to specify the “total number of illnesses”; one shows “reports of consumer
injuries” while six show “NA” (meaning “not available or not reported”).
One of the entries, a 1991 outbreak where two hundred sixty-five 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 thirteen outbreaks indicate that someone was hospitalized—one person in one case, four in the
other. The remainder indicate that no data are available. Only one of the thirteen outbreaks specified whether there
were any deaths (six in a 1913 Minnesota outbreak). Again, the remainder indicated that no data are 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, from a scientific
standpoint, be 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.
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 two million pounds of raw butter
over the past twenty years without illness. About ten 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 one hundred twelve years, the FDA denial of the petition could be vulnerable to a court
challenge in other areas.

NEW INFORMATION RESOURCE FOR WAPF MEMBERS

Consult with Pete Kennedy on state laws, regulations and policies including food freedom legislation and issues regarding
consumer access to raw milk, cottage foods and on-farm meat and poultry processing. (Pete cannot give individual legal
advice or recommend support for or opposition to pending legislation.) Contact Pete at pete@realmilk.com.

SPRING 2020 Wise Traditions 99