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Groups Want Proof of Cattle Drug’s Safety

(CN) - The FDA dragged its heels to produce documents about the safety of ractopamine, an animal feed additive that boosts lean muscle growth, activists claim in federal court.

The Animal Legal Defense Fund and Center for Food Safety - both nonprofit organizations - sued the Food and Drug Administration in U.S. District Court in San Francisco over Freedom of Information Act requests they claim have gone unanswered by the agency.

Both groups filed FOIA requests with the FDA, seeking documents regarding the agency's approval of the drug ractopamine for animal use. Ractopamine increases heartbeat and the contraction of cardiac tissue, according to the activists' complaint.

The meat industry uses ractopamine to enhance lean muscle growth and inhibit fat production in animals. However, the nonprofits say the drug is also linked to health problems in animals including cardiovascular stress, "downer" animals that are unable to get up or walk, hoof lesions and increased aggression.

"Many foreign jurisdictions, including the European Union, China, and Russia ban the importation of meat that contains any ractopamine residue," the groups say in their complaint.

Additionally, Tyson, Inc. - the world's second largest meat processor - recently announced that it would no longer accept cattle that have been fed the drug Zilmax, which is in the same class as ractopamine.

The Animal Legal Defense Fund claims it requested records from the FDA in August, 2012 regarding the "psychological, physiological and behavioral effects of the animal drug ractopamine on humans and non-human animals." According to the group, the FDA repeatedly promised delivery of the documents but "ultimately produced nothing."

In March of 2013, after the animal rights group appealed the FDA's non-production, the agency released "one half of one percent of the responsive documents the agency says it has collected - that were the exact same compilation of records produced for a reporter in 2011," the complaint states. (Emphasis in original.)

Shortly afterward, the FDA allegedly excused its delay by telling the group it was "in the process of securing additional staff to address the many requests in our backlog."

The Center for Food Safety says it requested similar FDA records "related to the environmental, human, and animal health effects of ractopamine" earlier this year, with a similar lack of results from the agency.

"In the eight months since the center submitted its request, it has received responses from three divisions within FDA, but an additional division with responsive records has offered repeated promises of forthcoming documents yet provided no estimated decision date and has ultimately produced nothing," the activists claim in the complaint.

So far, the Center for Food Safety says it has received nothing from that division in response to its request and nothing in response to its administrative appeals filed in March and April of 2013. Under FOIA, agencies have just 20 days to respond to initial requests and another 20 days to respond to appeals for more information.

"Courts have held that an eight-month delay following a request with 'no further information regarding the timeline for processing the request cannot be described as a model of due diligence," the groups say, citing Government Accountability Project v. U.S. Department of Health and Human Services.

The nonprofits seek a court order compelling the FDA to produce all records requested by plaintiffs as quickly as possible. They also want a declaration from the court declaring the FDA's foot-dragging as "unlawful."

The Animal Legal Defense Fund, based in Cotati, Calif., is represented by in-house counsel Carter Dillard. The Center for Food Safety is represented by in-house counsel Paige Tomaselli.

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