Raw milk law amendment would not ‘mitigate’ dangers - FDA

By Mark ASTLEY contact

- Last updated on GMT

Related tags: Raw milk, Milk

Raw milk law amendment would not ‘mitigate’ dangers - FDA
The US Food and Drug Administration (FDA) has rejected a petition that sought an exception to the current ban on the inter-state sale of raw milk products – citing a lack of proof that the amendment would "adequately mitigate the dangers posed by raw milk."

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.

Related topics: Regulation & Safety, Fresh Milk

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7 comments

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FDA not the bogeyman

Posted by Richard,

The FDA does not have the powers implied below. Indeed for a regulation change the FDA must publish the propsed change in the Federal Register, a daily government publication open to everyone, and allow a waiting period of several months, which is often extended. The FDA is required by law to answer every comment and concern sent in on the new regulation. Then the regulation is revamped based on feedback and again it is published in the Federal Regester for review. Again the FDA receives and responds to feedback which leads to a new revamped regulation published in the Federal Regester. Regulation changes can take decades...

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Learn some history

Posted by eric,

Ever heard of tuberculosis, diptheria, brucellosis or scarlet fever. All reduced or prevented by pasteurization.

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Who or what will mitigate the dangers of the FDA?

Posted by bachcole,

Who or what will mitigate the dangers of the FDA? Separation of powers isn't working. Congress gave the FDA power to make it's own laws. The FDA regularly ignores court orders. Congress is too corrupt to care. The President thinks that it is just grand that government takes care of us. The Supreme Court seems to be oblivious to the separation of power doctrine. Who or what will mitigate the dangers of Big Government and in particular the FDA?

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