Pesticide Research in Human Subjects

2008-03-03: We're updating this page. We appreciate your patience.

Proposed Regulation

Environmental Protection Agency. 40 CFR Part 26 [OPP-2003-0132; FRL-7728-2] RIN 2070-AD57. Protections for Subjects in Human Research, Proposed rule. September 12, 2005: http://www.epa.gov/fedrgstr/EPA-GENERAL/2005/September/Day-12/g18010.htm

EPA Backgrounder: EPA Significantly Strengthens and Expands Protections for Human Studies Research. 2006-01-26: http://www.epa.gov/oppfead1/guidance/human-test.htm

EPA Human Studies Review Board

EPA Human Studies Review Board (HSRB) home page: http://www.epa.gov/OSA/hsrb/index.htm

EPA Human Studies Review Board (HSRB) roster of members: http://www.epa.gov/OSA/hsrb/members.htm

EPA Human Studies Review Board (HSRB) meeting page: http://www.epa.gov/OSA/hsrb/meetings.htm

To access EPA HSRB materials for the meeting of April 4-6, 2006:

1. Go to the search form at http://www.regulations.gov/fdmspublic/component/main?main=AdvancedDocument
2. Click the radio button for All Documents
3. Select Environmental Protection Agency in the Agency pull-down menu
4. Enter EPA-HQ-ORD-2006-0187 in the Keyword search form
5. Click the radio button for Exact Phrase (below the Keyword or ID search form)
6. Click the Submit button

Disable the pop-up blocker in your web browser (as applicable) or you won't be able to access the documents.

NB: the search results are less than ideal; to access documents of interest, select the Docket ID link. Don't forget to check the record count (often there is more than one screen of information). You can scroll through the entire list of documents (without getting lost) by changing the Number of Records to Display from 25 to 200.

To access documents and materials from other EPA HSRB meetings, go the EPA Human Studies Review Board (HSRB) meeting page: http://www.epa.gov/OSA/hsrb/meetings.htm; select one of the meeting links and follow instructions.

Comments on the Use of Data from Testing of Human Subjects. EOA-SAB-EC-00-0017. Environmental Protection Agency. 2000: http://www.epa.gov/sab/pdf/ec0017.pdf

Staff Background Paper for November 30, 1999 Meeting of SAB/SAP Joint Subcommittee on Data from Human Subjects. Environmental Protection Agency: http://www.epa.gov/scipoly/sap/1999/november/background-1130.pdf

Dramatis Personae

Inveresk Clinical Research: http://www.magicmultimedia.com/portfolio/icr/icrframe.htm

Inveresk Clinical Research: http://www.inveresk.com/

Lincoln Lab Is Only One in U.S. to Test Pesticides on Humans. Jake Thompson. Omaha World–Herald. 1999-12-19: http://www.sare.org/sanet-mg/archives/html-home/40-html/0390.html

Human testing faces ethical scrutiny. Brent Walth and Alex Pulaski. The Oregonian. 1999-12-08: http://ace.orst.edu/info/tox513/Oregonian_apple_articles/Human_testing_12-8-99.htm

He was used to test highly hazardous pesticides and then forgotten about. Jennifer Johnston. Sunday Herald. 2002-09-08: http://www.sundayherald.com/print27510

Charnley G, Patterson J. Review of Procedures for Protecting Human Subjects in Recent Clinical Studies of Pesticides. 2003-06-30: http://www.tera.org/pubs/humanstudiesmanuscript%20accepted.pdf

Reports and Publications

The English Patients Human Experiments and Pesticide Policy. Environmental Working Group. 1998-06: http://www.ewg.org/reports_content/english/English.pdf

Oleskey C, Fleischman A, Goldman L, Hirschhorn K, Landrigan PJ, Lappé M, Marshall MF, Needleman H, Rhodes R, McCally M. Pesticide Testing in Humans: Ethics and Public Policy. Environmental Health Perspectives. 2004;112(8):914-919. Available from http://www.ehponline.org/members/2004/6522/6522.pdf

Intentional Human Dosing Studies for EPA Regulatory Purposes: Scientific and Ethical Issues. Institute of Medicine, National Academies of Science. 2004. Accessed on 2006-04-20 at: http://darwin.nap.edu/books/0309091721/html

Ethical Considerations for Research on Housing-Related Health Hazards Involving Children. Institute of Medicine, National Academies of Science. 2005. Accessed on 2006-04-20 at: http://www.nap.edu/books/0309097266/html

Human Pesticide Experiments. United States House of Representatives, Committee on Government Reform—Minority Staff Special Investigations Division and United States Senate, Office of Senator Barbara Boxer, Environmental Staff. June, 2005. Accessed on 2006-04-20 at: http://www.democrats.reform.house.gov/Documents/20050627115401-68567.pdf

Litigation

CropLife America, et al., Petitioners vs. Environmental Protection Agency, Respondent. Natural Resources Defense Council and American Chemistry Council, Intervenors. On Petition for Review of an Order of the Environmental Protection Agency. Case No. 02-1057. United State Court of Appeals for the District of Columbia Circuit. 2003-06-03: http://pacer.cadc.uscourts.gov/cgi-bin/getopn.pl?OPINION=02-1057A.DC. Accessed on 2006-03-09.

Related Common Rule Faux-Pas

Meyer RJ. OHRP Determination Letter to Loma Linda University. 2002-11-14: http://www.hhs.gov/ohrp/detrm_letrs/YR02/nov02c.pdf

Meyer RJ. OHRP Determination Letter to Loma Linda University. 2003-01-23: http://www.hhs.gov/ohrp/detrm_letrs/YR03/jan03c.pdf

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Last Updated: 2008-03-03

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