Human Studies Review Board Reviews Pesticides and Nanosilver Issues
On October 19-20, 2011, The U.S. EPA's Human Studies Review Board will meet to advise the Agency on EPA's scientific and ethical reviews of research with human subjects. The HSRB's meeting agenda includes several pesticide and nanosilver issues. This meeting is open to the public, and the public may submit comments on or before Wednesday, October 12, 2011.
The HSRB is a Federal advisory committee operating in accordance with the Federal Advisory Committee Act (FACA) 5 U.S.C. App.2 9. The HSRB provides advice, information, and recommendations to EPA on issues related to scientific and ethical aspects of human subjects research. The major objectives of the HSRB are to provide advice and recommendations on: (1) Research proposals and protocols; (2) reports of completed research with human subjects; and (3) how to strengthen EPA's programs for protection of human subjects of research. The HSRB
reports to the EPA Administrator through EPA's Science Advisor.
At its meeting on October 19 and 20, 2011, the HRB will consider scientific and ethical issues surrounding these topics:
a. A new scenario design and associated protocol from the Antimicrobials Exposure Assessment Task Force II, describing proposed research to monitor the dermal and inhalation of workers while pouring liquid antimicrobial pesticide products from both conventional and reduced-splash containers. EPA requests the advice of the HSRB concerning whether, if it is revised as suggested in EPA's review and if it is performed as described, this research is likely to generate scientifically reliable data, useful for assessing the exposure of those who pour liquid antimicrobial pesticide products from conventional and reduced-splash containers, and to meet the applicable requirements of 40 CFR part 26, subparts K and L.
b. A new scenario design and associated protocol from the Agricultural Handler Exposure Task Force describing proposed research to measure dermal and inhalation exposure to workers who load liquid pesticides with closed system equipment. EPA requests the advice of the HSRB concerning whether, if it is revised as suggested in EPA's review and if it is performed as
described, this research is likely to generate scientifically reliable data, useful for assessing the exposure of those who load liquid pesticides with closed system equipment, and to meet the applicable requirements of 40 CFR part 26, subparts K and L.
c. The unpublished report of the completed Carroll-Loye Biological Research, Inc. study No. Mas-003 to evaluate in the field the repellent efficacy against mosquitoes of a product containing 16% para-methane3,8-diol and 2% lemongrass oil. The protocol for this study was reviewed favorably by the HSRB at their meeting in October 2010. EPA seeks the advice of the HSRB on the scientific soundness of this completed study for use to estimate the duration of complete protection against mosquitoes provided by the tested repellent, and on whether available information supports a determination that the study was conducted in substantial compliance with subparts K and L of 40 CFR part 26.
d. A published report by Moiemen et al. (2010) of an intentional exposure human study measuring dermal absorption of silver from the use of nanosilver-containing wound dressings to treat major burns. EPA seeks the advice of the HSRB on the scientific soundness of this completed study for use in support of an assessment of the absorption of nanosilver particles through the skin, and on whether there is adequate information to determine that the study was conducted in substantial compliance with procedures at least as protective as those in subparts A-L of EPA's regulation at 40 CFR part 26.
Click here to read Federal Register notice of HSRB meeting