Johnson, who is working to shepherd a rule that allows limited third-party human pesticide exposure studies through the agency on an expedited basis, already faces pressure following similar concerns raised by congressional leaders and environmentalists‚ the agency is moving to allow submission of studies involving human subjects from other realms, such as academia or industry.
Risk Policy Report
November 1, 2005
EPA’s children’s health advisers are recommending that the agency examine and remove possible loopholes in the agency’s proposal to ban pesticide studies that intentionally dose pregnant women and children. The Children’s Health Protection Advisory Committee (CHPAC) drafted a letter Oct. 26 to EPA Administrator Stephen Johnson outlining “a number of weaknesses and ambiguities” in the proposed ban that they say will undercut the ban’s intent.
Johnson, who is working to shepherd a rule that allows limited third-party human pesticide exposure studies through the agency on an expedited basis, already faces pressure following similar concerns raised by congressional leaders and environmentalists. However, EPA has, in many cases, been unresponsive to CHPAC’s concerns.
At an Oct. 25-26 meeting, CHPAC members opted to strengthen an earlier draft letter encouraging EPA to remove language that they say could allow dose-response tests on children and fetuses. The letter also recommends the agency remove language that CHPAC says gives the EPA administrator unchecked authority to waive the ban. Relevant documents are available on InsideEPA.com.
EPA’s proposal seeks to address how the agency will handle third-party pesticide studies that include human test subjects. The agency does not conduct any tests on humans, nor does it fund such tests. However, the agency is moving to allow submission of studies involving human subjects from other realms, such as academia or industry, after Congress included language in the agency’s fiscal year 2006 spending law requiring the agency to issue a rule on acceptable test procedures.
One controversial part of EPA’s proposed rule considers the intentional dose studies, in which volunteers are exposed to pesticides in order to determine any potential health risks. The agency included in the proposal several measures designed to ensure tests are ethical. For example, the agency has proposed to create an internal review board to examine the studies to be sure they correspond to ethics guidelines.
However, Democratic lawmakers and environmentalists have voiced concern that the rule, if enacted, would open the door to studies that could put children at risk. This prompted the agency to issue a proposed ban on any studies involving pregnant women or children.
Now, CHPAC members say that in its current format, the proposed ban fails to block such studies because several provisions in the rule undercut the ban. For example, the Oct. 26 draft letter states that the proposed ban could still allow “studies involving pregnant women, fetuses or children, as long as the tests are not conducted with the ‘intention’ of submitting them to EPA” under the Federal Insecticide, Fungicide & Rodenticide Act (FIFRA) or the Federal Food, Drug & Cosmetic Act (FFDCA), which dictate tolerance levels for pesticides and the registration process.
“As such, intentional dosing studies of pesticides which are conducted for the purposes of review by a foreign government or a state could be conducted and subsequently submitted to EPA for review under FIFRA or FFDCA, without running afoul of the new regulations,” the draft CHPAC letter states.
CHPAC says that one solution to this concern is for EPA to “extend the prohibition of third-party intentional dosing studies of pesticides using pregnant women and children as subjects to studies conducted for any purpose and submitted to EPA under any statutory authority,” according to the letter.
The draft letter also outlines other criticisms, including a provision in the proposed ban that gives the EPA administrator broad authority to waive any protective measures contained in the language of the regulation.
CHPAC notes that the agency’s proposal empowers the administrator to waive any or all of the restrictions. The ban language states, “In appropriate circumstances, the Administrator may, under [section] 26.101(e) waive the applicability of some or all of the requirements of these regulations for research of this type.” The committee urges the agency to remove such “sweeping authority” from the administrator when the studies involve children.
The draft letter also addresses concerns over the ethics of any studies involving children, saying the committee “could not foresee any situations in which it would be ethical to intentionally dose pregnant women, fetuses or children.” CHPAC also encouraged EPA to grant “a degree of authority” to the Human Studies Review Board, an internal board EPA is considering creating to handle ethical issues involved in human pesticide test data.
EPA officials did not return calls seeking comment on the effect a letter from CHPAC might have on the proposal.
CHPAC has weighed in on other issues before but has had little success in winning change at EPA. For example, committee members were highly critical of EPA’s power plant mercury rule. Johnson asked CHPAC to review guidance documents for the mercury rule when he served as assistant administrator for the agency. But EPA has yet to respond to two letters, dated Nov. 8, 2004, and Jan. 4, 2005, which stem from that request. However, most letters written since 2000 have at least received an official response, according to the agency’s Web site.
The committee will work to finalize the language of the letter before it is sent to Johnson.