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EPA TO OKAY HUMAN TESTS OF PESTICIDES
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" T T Ι Ι Ι Ι Ι Ι ί ! ί ί Μ Ι Ι Ι Ι ïfeËggg RESEARCH ETHICS EPA TO OKAY HUMAN TESTS OF PESTICIDES Draft rule omits some safeguards sought by National Research Council A LEAKED DRAFT EPA RULE on using human volunteers for tests of pesticides and toxic chemicals has drawn a sharp response from Congress. The proposal follows some of the recommendations of a Feb- ruary 2004 National Research Council report on the subject. But the draft omits several safe- guards and allows certain exper- iments that NRC said should be prohibited. For example, the draft pro- posal allows exposure studies on children if conducted during chil- dren's normal activities and not used to identify a toxic effect. NRC, in contrast, concluded that studies on pregnant women, as well as children, newborns, and prisoners, would generally be un- ethical. NRC also recommend- ed that EPA establish a review board to evaluate all human dos- ing studies, but the EPA propos- al does not require such a board. The agency says a review board "would unnecessarily confine EPA's discretion." EPAs controversial proposal has led to conflicting amendments being passed in the Senate. On June 29, the Senate addressed pes- ticide testing in two amendments to the appropriations bill for in- terior and related agencies. One measure, by Sen. Barbara Boxer (D-Calif), prohibits EPA from spending any funds to consider third-party pesticide studies— those conducted by industry or outside organizations—in which humans are intentionally dosed. The second measure, by Sen. Conrad Burns (R-Mont.), in- structs EPA to conduct a thor- ough review of human pesticide dosing studies and to issue a final rule on the conduct of such stud- ies within 180 days. Last month, the House ap- proved a measure similar to the Boxer amendment. EPAsays the draft proposal has not been reviewed by Adminis- trator Stephen L. Johnson and that the agency had not planned to re- lease the proposal until August. "EPAis taking the historic step of regulating, for the first time, sci- entific and ethical standards for accepting third-party human stud- ies, and it's unfortunate that mem- bers of Congress have chosen to politicize this important issue," the agency says in a statement. Human clinical trials with pes- ticides have been controversial for nearly a decade. To protect chil- dren, the 1986 Food Quality Protection Act established an addition- al 10-fold margin of safe- ty to be applied to pesti- cide exposures when extrapolating from ani- mal to human data Soon after that, EPAbegan re- ceiving the results of human pes- ticide tests from companies. If tests showed that humans were not more sensitive to a pesticide than experimental lab animals, the agency could eliminate the 10-fold safety factor for extrapolating from animals to humans, making it easier for companies to get their products approved. In 1998, EPAstopped accept- ing such studies, but in 2001, it began considering them on a case-by-case basis and asked for guidance from NRC. CropLife America, which rep- resents major pesticide manu- facturers, "believes that sound science and public health pro- tections have affirmed the safe- ty and ethics of human data stud- ies."-BETTEHILEMAN DOSING Pesticide spews from the back of a mosquito control truck in Miami Dade County, Fla. PHILANTHROPY Gates Foundation Awards 43 Grants For Global Health Research A global health initiative that was launched in 2003 by the Bill & Melinda Gates Foun- dation has awarded 43 grants totaling $436 million for a broad range of innovative re- search projects designed to prevent, treat, and cure diseases of the developing world. The 43 projects are grouped under seven ma- jor goals: • Develop improved childhood vaccines that do not require refrigeration, needles, or multi- ple doses. • Create new vaccines to prevent malaria, tu- berculosis, and HIV infection. • Develop new ways to prevent insects from transmitting diseases such as dengue. • Discover ways to prevent drug resistance in infectious microorganisms. • Create therapies to cure latent and chronic infections such as tuberculosis. • Develop technologies to diagnose and track diseases more accurately in poor countries. • Grow more nutritious versions of staple crops such as rice and cassava to combat mal- nutrition. "It's shocking how little research is directed toward the diseases of the world's poorest countries," says Bill Gates, cofounder of the Gates Foundation. The Grand Challenges in Global Health initiative, he believes, "can trans- form health in the developing world and save millions of lives." The initiative is supported by a $450 million commitment from the foundation, with addi- tional funding of $31.6 million from the Well- come Trust and the Canadian Institutes of Health Research. The 43 projects that have been funded were selected from more than 1,500 projects pro- posed by scientists in 75 countries. Some pro- posals are still under review and may be award- ed grants later this year, the foundation says.-RON DAGANI WWW.CEN-0NLINE.ORG C&EN / JULY A, 2005 9 NEWS OF
Transcript of EPA TO OKAY HUMAN TESTS OF PESTICIDES
" T T Ι Ι Ι Ι Ι Ι ί ! ί ί Μ Ι Ι Ι Ι ïfeËggg R E S E A R C H E T H I C S
EPA TO OKAY HUMAN TESTS OF PESTICIDES Draft rule omits some safeguards sought by National Research Council
A LEAKED DRAFT EPA RULE
on using human volunteers for tests of pesticides and
toxic chemicals has drawn a sharp response from Congress.
The proposal follows some of the recommendations of a February 2004 National Research Council report on the subject. But the draft omits several safeguards and allows certain experiments that NRC said should be prohibited.
For example, the draft proposal allows exposure studies on children if conducted during children's normal activities and not used to identify a toxic effect. NRC, in contrast, concluded that studies on pregnant women, as well as children, newborns, and prisoners, would generally be unethical. NRC also recommended that EPA establish a review board to evaluate all human dosing studies, but the EPA proposal does not require such a board. The agency says a review board "would unnecessarily confine EPA's discretion."
EPAs controversial proposal has led to conflicting amendments being passed in the Senate. On June 29, the Senate addressed pesticide testing in two amendments to the appropriations bill for interior and related agencies. One measure, by Sen. Barbara Boxer (D-Calif), prohibits EPA from spending any funds to consider third-party pesticide studies— those conducted by industry or outside organizations—in which humans are intentionally dosed. The second measure, by Sen. Conrad Burns (R-Mont.), instructs EPA to conduct a thorough review of human pesticide dosing studies and to issue a final
rule on the conduct of such studies within 180 days.
Last month, the House approved a measure similar to the Boxer amendment.
EPAsays the draft proposal has not been reviewed by Administrator Stephen L. Johnson and that the agency had not planned to release the proposal until August. "EPAis taking the historic step of regulating, for the first time, scientific and ethical standards for accepting third-party human studies, and it's unfortunate that members of Congress have chosen to politicize this important issue," the agency says in a statement.
Human clinical trials with pesticides have been controversial for nearly a decade. To protect chil
dren, the 1986 Food Quality Protection Act established an additional 10-fold margin of safety to be applied to pesticide exposures when extrapolating from animal to human data Soon after that, EPAbegan receiving the results of human pesticide tests from companies. If tests showed that humans were not more sensitive to a pesticide than experimental lab animals, the agency could eliminate the 10-fold safety factor for extrapolating from animals to humans, making it easier for companies to get their products approved.
In 1998, EPAstopped accepting such studies, but in 2001, it began considering them on a case-by-case basis and asked for guidance from NRC.
CropLife America, which represents major pesticide manufacturers, "believes that sound science and public health protections have affirmed the safety and ethics of human data stud-ies."-BETTEHILEMAN
DOSING Pesticide spews from the back of a mosquito control truck in Miami Dade County, Fla.
P H I L A N T H R O P Y
Gates Foundation Awards 43 Grants For Global Health Research
A global health initiative that was launched in 2003 by the Bill & Melinda Gates Foundation has awarded 43 grants totaling
$436 million for a broad range of innovative research projects designed to prevent, treat, and cure diseases of the developing world.
The 43 projects are grouped under seven major goals:
• Develop improved childhood vaccines that do not require refrigeration, needles, or multiple doses.
• Create new vaccines to prevent malaria, tuberculosis, and HIV infection.
• Develop new ways to prevent insects from transmitting diseases such as dengue.
• Discover ways to prevent drug resistance in infectious microorganisms.
• Create therapies to cure latent and chronic infections such as tuberculosis.
• Develop technologies to diagnose and track diseases more accurately in poor countries.
• Grow more nutritious versions of staple crops such as rice and cassava to combat malnutrition.
"It's shocking how little research is directed toward the diseases of the world's poorest countries," says Bill Gates, cofounder of the Gates Foundation. The Grand Challenges in Global Health initiative, he believes, "can transform health in the developing world and save millions of lives."
The initiative is supported by a $450 million commitment from the foundation, with additional funding of $31.6 million from the Wellcome Trust and the Canadian Institutes of Health Research.
The 43 projects that have been funded were selected from more than 1,500 projects proposed by scientists in 75 countries. Some proposals are still under review and may be awarded grants later this year, the foundation says.-RON DAGANI
W W W . C E N - 0 N L I N E . O R G C&EN / JULY A, 2005 9
NEWS OF
