WASHINGTON, Oct. 1, 2013 – The Food and Drug Administration said Monday that it is withdrawing prior approval for a number of arsenic-containing compounds that once were used as additives in feed for chickens, turkeys and hogs. In response to a petition filed four years ago by the Center for Food Safety and the Institute for Agriculture and Trade Policy, Deputy FDA Commissioner Michael Taylor said approvals for three such compounds are being cancelled at the request of the manufacturers but more study was needed before acting on a fourth.

Additives containing arsenic have not been important to the poultry industry for several years. “The only arsenical used as a feed additive in broiler production in the last 10 years, roxarsone, was suspended in 2011 and the product is no longer manufactured or used,” Ashley Peterson, National Chicken Council vice president of scientific and regulatory affairs, says. “No other feed additives containing arsenic are currently used in broiler meat production in the United States.”

Taylor’s response to the petition from the two interest groups characterizes the decision as the result of several years of “actively gathering additional information to enable us to more fully evaluate any potential concerns regarding the safety of those drugs.” Because the manufacturers of roxarsone, carbarsone and arsanilic acid have asked FDA to withdraw the approvals, the petition’s requests “are therefore moot,” Taylor’s letter said. The agency is in the process of formally withdrawing approval and amending its animal drug regulations accordingly.

“The scientific evidence at the time of the approval of all four arsenic-based animal drugs indicated that animals exposed to organic arsenic rapidly excrete the compound in its original form,” he explained. However, research in recent years began to question whether organic arsenic (which is not carcinogenic) could become the inorganic, potentially cancer-causing form.

Of the three chemicals, FDA said that carbarsone has not been marketed since at least 1996 and arsanilic acid has not been on the market in 2005. The agency began testing roxarsone, “the much more commonly used arsenic-based animal drug,” in 2009 and detected for the first time very low levels of inorganic arsenic, the potentially cancer-causing form, in chicken liver. For the fourth compound, nitarsone, FDA needs to evaluate its own research and comments from Zoetis, its manufacturer, before deciding whether to take action, Taylor said.

In a statement, CFS and IATP sought to portray the decision as “a major victory for consumers and the health of our food system” and claimed credit for bringing the legal pressure that spurred FDA action. “The actions by FDA and industry confirm what we’ve been saying for seven years, the use of arsenic in animal feed is not necessary and poses needless risk to public health,” says Ben Lilliston of IATP, who wants FDA to undertake “a more comprehensive evaluation of health risks associated with animal feed produced by the pharmaceutical industry.”


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