Judge Grants Summary Judgment in Favor of Butter Pasteurization Regulations

In a Monday opinion, a District of Columbia District Court judge found in favor of the Food and Drug Administration in a motion for summary judgment opinion. The plaintiffs, Mark McAfee and the Farm-to-Consumer Legal Defense Fund, brought the case to challenge whether the rules requiring pasteurization of dairy products sold across state lines should apply to butter as well.

The judge recounted the history of the pasteurization requirement, first proposed in 1972 but not enacted until 1987, after objections were raised by the dairy industry. The FDA found that the requirement to pasteurize would help prevent disease outbreaks.

According to the opinion, the plaintiffs petitioned the FDA to make an exemption to these requirements for butter, and argued both that the agency lacks the authority to regulate butter and that there is no scientific basis for doing so.

The judge sided with the FDA as to their authority to regulate. The plaintiffs conceded that the Public Health Services Act “would seem to give the FDA authority to mandate pasteurization,” the opinion read, but argued instead that the Food, Drug and Cosmetic Act (FDCA) prohibits that mandate for butter. The FDCA, the plaintiffs argued, contains a statutory carve-out barring the creation of a “standard of identity” for butter specifically, and the mandate violates that carve-out.

The court did not find a conflict between the two laws, holding that “[T]here is no reason to suggest that the FDCA’s statutory definition of butter blocks the PHSA’s operation as Plaintiffs say it does,” as one statute concerns the spread of disease while the other concerns how food is presented to consumers. The judge also did not agree that the pasteurization mandate constitued a standard of identity for butter.

The court also rejected the plaintiffs’ arguments that the agency arbitrarily rejected their petition, instead finding that the agency’s finding was scientific, resulting in a “high level of deferrence.”

The plaintiffs were represented by Thom Ellingson PLLP.