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®: CRE Regulatory Action of the Week

FDA Sees EU Dioxin Limits as Source of Trade Dispute
The FDA has announced that the European Union's new and extraordinarily low limits for dioxin levels in animal feed, which are set to be enforced starting July 1, 2002, could lead to a major U.S.-EU trade dispute. The EU recently set acceptable dioxin levels in animal feed at 0.75 parts per trillion (ppt), and Stephen Sundlof, Director of FDA's Center for Veterinary Medicine, told a National Academy of Sciences panel in January that he is uncertain that U.S. producers can meet this standard. According to a February 8, 2002 FDA Week report, U.S. industry is likewise concerned that detecting dioxin at such low levels is simply not feasible.

The threatened trade war looms as EPA wrestles with the bottom line of its long awaited dioxin risk assessment, and litigation over the reassessment continues. In 2000, EPA released a draft version of the report stating that dioxin posed cancer risks as high as 1 in 100 for some individuals. Last year EPA's Science Advisory Board cast doubt on the agency's draft report, however, with a majority of the SAB members voting against classifying dioxin as carcinogenic to humans.

CRE Board Member Jim Tozzi and other plaintiffs have sued EPA over the dioxin report, and the new trade dispute will raise the stakes in that suit for both the FDA and industry. A final EPA dioxin reassessment classifying the chemical as "carcinogenic to humans" would significantly undermine arguments of the FDA and others challenging the severity of the EU's new regulations.

Tozzi has written to CVM Director Sundlof to alert him to the potential negative effects of the EPA dioxin reassessment on U.S. feed exports. Tozzi's letter urges Sundlof and CVM to participate actively in the upcoming interagency review of the EPA dioxin reassessment and to oppose issuance of the alarming "carcinogenic to humans" hazard classification.

  • Read Tozzi letter to CVM Director Stephen Sundlof
  • Read FDA remarks to NAS on dioxin levels in animal feed
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  • View past CRE Regulatory Action of the Week items