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February 11, 2002
Dr. Stephen F. Sundlof
Dear Dr. Sundlof: The Center for Regulatory Effectiveness would like to commend you for your statement to the National Academy of Sciences last month regarding the European Union's new maximum residue levels (MRL) for dioxin in animal feed and, specifically, for noting that the new EU standards raise potentially serious trade implications for U.S. feed producers. As you indicated, beginning in July 2002 the EU plans to impose a new dioxin MRL of 0.75 parts per trillion, an extraordinarily low level which will exceed the detection capabilities of many laboratories. The 0.75 ppt level will impose huge new costs on feed producers, yet it is not at all clear that this low residue level is necessary to protect public health. The new EU standards go into effect at a time when the U.S. Environmental Protection Agency is preparing to issue its own conclusions regarding dioxin health risks. A final version of EPA's report, "Exposure and Human Health Reassessment of 2,3,7,8-Tetrachlorodibenzo-p-Dioxin (TCDD) and Related Compounds", is expected to be released later this year. The final EPA report, which has been underway for over a decade, will be widely viewed as the U.S. government's last word on dioxin risk. A key issue in the EPA dioxin reassessment, which the agency has yet to fully resolve, is whether to identify dioxin as "carcinogenic to humans", even in the absence of conclusive epidemiologic data. While rodent studies do show a strong relationship between dioxin exposure and cancer in animals, the human data are far less clear. In the event the EPA report does classify dioxin as "carcinogenic to humans", that finding could have a substantial impact on U.S. negotiations with Europe over a more appropriate MRL for animal feed. To date, the EPA dioxin reviews have been conducted largely at the technical level, with only indirect discussion of broader policy implications such as the foreign trade issue you have identified. Given that the confidence levels on dioxin's human carcinogenicity are so low, however, we believe there are strong public policy reasons for the U.S. government to refrain from proclaiming that it knows dioxin is "carcinogenic to humans". EPA has announced that its dioxin reassessment will undergo a formal interagency review by FDA and USDA prior to release. We urge you and other CVM officials to participate actively in this review and to take a firm stance against an EPA dioxin hazard characterization that would needlessly threaten U.S. animal feed exports, including exports to EU countries. Sincerely,
cc: Read FDA remarks to NAS on dioxin levels in animal feed |
