The petition was filed by raw milk product manufacturer, Organic Pastures, in 2008. The company requested an amendment to CFR 1240.61 – the regulation that prohibits the distribution of dairy products made from unpasteurised milk across US state lines.
The sale of raw milk for human consumption is currently legal within the borders of several US states, including Washington, California, Pennsylvania and Utah. In its petition to the FDA, California-based Organic Pastures requested an exception to the current inter-state ban on sales.
“Raw milk that is tested, state inspected, state regulated, carries a ‘government warning statement’ and labelled for retail sale in one state may be transported to another state if that state allows the sale of raw unpasteurised milk and or dairy products,” said the requested amendment.
In a 26 February 2013-dated letter, Michael M. Landa, director of the Center for Food Safety and Applied Nutrition (CFSAN) at the FDA, informed Organic Pastures CEO, Mark McAfee, that it was “denying” the petition.
According to Landa, the petition did not demonstrate “any reasonable grounds” to revise CFR 1240.61.
Advances do not “ensure safety of raw milk”
In its petition, Organic Pastures claimed that “advances in technology and microbiology now allow the production of sale raw milk to [become] a reality and not just random chance.”
In response, the FDA stated that it was “unaware of any advancement in the understanding of microbiology which would ensure the safety of raw milk.”
According to the agency, raw milk can harbour dangerous microorganisms such as Salmonella, E.coli, and Listeria. These microorganisms are responsible for causing numerous foodborne illnesses, according to the FDA.
“Based on its analysis of the materials you provided in your petition, along with other data and information, FDA has concluded that your petition fails to establish that current testing, state inspection, and state regulation programs can adequately mitigate the dangers posed by raw milk,” said the FDA letter.
“Your petition also fails to establish that a warning statement could adequately address the dangers posed by raw milk.”
“Furthermore, your petition does not substantially show that your proposal is in the public interest or will promote the objectives of FDA and the statutes it administers."
Organic Pastures was not immediately available to comment on the FDA decision.
Lawsuit forced FDA to take action
Late last year, Organic Pastures’ petition became the subject of a lawsuit.
In December 2012, Organic Pastures filed a lawsuit against the FDA alleging that the agency had repeatedly failed to respond to its December 2008 petition. The lawsuit sought a Writ of Mandamus ordering the FDA to take final action on the petition.
Under federal law, the FDA has up to 180 days – roughly half a year – to respond to a written petition. Nearly four years had passed since Organic Pastures filed its petition with the FDA.