Human Experiments  

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Date Title Source
September 12, 2005

Protections for Subjects in Human Research. Proposed Rule. US EPA.

This proposal, the first of several possible Agency actions, focuses on third-party intentional dosing human studies for pesticides, but invites public comment on alternative approaches with broader scope.

... This proposal, however, focuses on the most pressing of issues: defining appropriate ethical standards for investigator conduct and for Agency use of third-party intentional dosing human studies for pesticides.


B. Proposal
EPA proposes to extend the requirements of EPA's Common Rule (40
CFR 26.101 through 26.124) to third-party research conducted after the
effective date of the rule, which involves intentional exposure of
human subjects, if the researcher intended to submit the resulting
information to EPA, or to hold the information for later inspection by
EPA, under FIFRA or the FFDCA.


... In the United States, the National Commission for the Protection of
Human Subjects of Biomedical and Behavioral Research issued in 1978 The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research. This document can be found in the docket for this proposed rule and on the web at For many U. S. federal departments and agencies, the principles of the Belmont Report are
implemented through the Federal Policy for the Protection of Human Subjects (the Common Rule). The Common Rule, promulgated by 15 federal departments and agencies, including the EPA, on June 18, 1991 (56 FR 28003), applies to all research involving human subjects conducted, supported or otherwise subject to regulation by any federal department or agency that has adopted the Common Rule and has taken appropriate administrative action to make it applicable to such research. The Common Rule as promulgated by EPA (40 CFR part 26) has applied to human subjects research conducted or supported by EPA since it was put into place in 1991.


The World Medical Association, a voluntary federation of national medical associations, has developed and maintains ethical standards documented in the Declaration of Helsinki, first issued in 1964 and revised several times since then. The latest version of the Declaration is available at: These
standards apply internationally to research on the diagnosis and treatment of human disease, or that adds to understanding of the causes and development of disease.

Under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) (7 U.S.C. 136-136y), EPA requires pesticide companies to conduct studies needed to evaluate the safety of their products. While some studies involving human subjects are required, EPA has never required intentional dosing human toxicity studies with pesticides. EPA has, however, required studies to measure potential exposure to pesticides of users or of workers and others who re-enter areas legally treated with pesticides. Other required tests have evaluated the effectiveness of pesticide products intended to repel insects and other pests from human skin. In addition, EPA has required studies to define pesticide metabolism and metabolic products in humans, as a guide to interpretation of biomonitoring studies of agricultural workers and others to protect them from exposure to potentially dangerous levels of pesticide residues.

... Submission of these studies following FQPA elicited a strong expression of public concern. In response, EPA convened an advisory committee under the joint auspices of the EPA Science Advisory Board (SAB) and the FIFRA Scientific Advisory Panel (SAP) to address issues of the scientific and ethical acceptability of such research. This
advisory committee, known as the Data from Testing of Human Subjects Subcommittee (DTHSS), met in December 1998 and November 1999, and completed its report in September 2000. Their report is available in the docket for this proposed rulemaking, and on the web at:

Comments on the use of data from the testing of human subjects. A report by the Science Advisory Board and the FIFRA Scientific Advisory Panel. US EPA. Report No. EA-SAB-EC-00-017. September 2000. 67 pages

C. Topics for Public Comment
The Agency has considered a number of alternatives to the positions described and invites public comment on whether EPA should adopt any of these alternatives for the final rule:

1. Should EPA continue the case-by-case approach articulated in the February 8, 2005, Federal Register Notice, not adopting by rule ethical standards to guide decision-making with respect to completed, ethically problematic human studies?

2. Should a final rule establish the standard that EPA would rely on all scientifically sound data from covered intentional exposure human studies relevant to EPA decision-making, without regard to any ethical deficiencies in the studies?

3. Should a final rule establish a different criterion for acceptance of research conducted before the effective date of the rule than the criterion proposed in Sec. 26.601 of the regulatory text? Should a final rule identify specific factors to be considered or criteria to be applied in determining whether research was
``fundamentally unethical'' or ``significantly deficient with respect to prevailing standards''?

4. Should a final rule establish the standard that, in making decisions under FIFRA and FFDCA, EPA would never rely on data from a study involving intentional exposure of any human subject to a pesticide when a purpose of the study was to identify or measure toxic effects?

5. Should a final rule establish the standard that EPA would not rely on an intentional exposure human study covered under proposed subpart F if the study did not comply with the Common Rule, without regard to when the research was conducted?

6. Should a final rule establish the standard in NAS Recommendation 5-7 for all three categories of completed research covered by proposed subpart F of the regulatory text--i.e., (1) Research conducted before the rule becomes effective; (2) research conducted after the rule becomes effective and required to comply with EPA's Common Rule; and
(3) research conducted after the rule becomes effective but not required to comply with EPA's Common Rule?

7. Should a final rule apply a different standard to research conducted after the effective date of the final rule, depending on whether the research was subject to the requirements of EPA's proposed subparts A through D?

8. Should a final rule apply proposed subpart F to a different range of third-party human research, including any of the categories discussed in Unit IV., or apply different ethical standards to research in different categories within an altered scope?

9. Should a final rule apply a standard other than ``substantial'' compliance with the requirements in EPA's proposed subparts A through D, perhaps requiring ``full'' or ``complete'' compliance with those requirements? How should minor, administrative deficiencies be treated under an alternative standard?

10. Should a final rule permit use of the exception procedure in proposed Sec. 26.603 when research falling within the prohibitions of proposed Sec. 26.221 or Sec. 26.421--i.e., research involving intentional exposure of pregnant women or children--is deemed crucial to the protection of public health?

11. Should a final rule identify additional factors EPA will consider in deciding whether to rely on a completed human study that does not meet the appropriate standard in proposed Sec. 26.601 or Sec. 26.602 of the regulatory text?

Federal Register.
Docket No. OPP-2003-0132
August 29, 2005

Memorandum to the File: Consisency of EPA's Proposed Human Studies Rule with the Nuremberg Code.

This memorandum discusses the basis for EPA’s conclusion that its proposed rule, Protections for Subjects in Human Research, is consistent with the principles of the Nuremberg Code. After quoting each of the ten principles in the Code (in italics), the Agency sets forth its analysis of how the proposed rule is consistent with the principle.

Federal Register Docket OPP-2003-0132-0247
August 25, 2005

Economic analysis of proposed rule: protectionsfor human research participants.

... For human studies not involving intentional dosing exposure, the Agency is not currently requiring third parties to submit information pertaining to the ethical conduct of completed human studies. Third parties are not required to comply with the Common Rule for such human studies, although many are generally responsive to the EPA’s guideline requirements which often refer to the Common Rule. The economic analysis focuses on the cost and benefits to industry and the Agency associated with human studies performed after publication of the rule. Using the current practice as the baseline for estimating the potential impact of the proposed rule, the incremental costs and benefits were analyzed for the four options. ... 45 pages

Biological and Economic Analysis Division, Office of Pesticide Programs, US EPA

Federal Register Docket OPP-2003-0132-0245

August 24, 2005

Memorandum: Request for Waiver of the FIFRA Scientific Advisory Panel's Review of the Proposed Rule Entitled: "Protections for Test Subjects in Human Research."

This document contains:

A July 2005 request to the FIFRA panel from Jim Jones" "... I am requesting that the Scientific Advisory Panel [SAP] waive its review of this proposed rule... EPA believes that additional review by the SAP at this time will not contribute measurably to the resolution of the scientific and ethical policy issues raised..."

An August 2005 response from the FIFRA SAP: "Attached please find the concurrence for the requested waiver of the FIFRA Scientifc Advisory Panel's Review of the proposed rule that addresses protections for test sujbects in human research."

From: Larry C. Dorsey, Executive Secretary, Scientific Advisory Panel

To: Jim Jones, Director,
Office of Pesticide Programs (7501C)

Federal Register Docket OPP-2003-0132-0244

August 11, 2005 EPA PROPOSES ONLY HALF-STEPS ON HUMAN CHEMICAL TESTING — Proposed Rule Riddled With Loopholes; Would Not Bar Infamous “CHEERS” Study Public Employees for Environmental Responsibility (PEER)
June 30, 2005 Limits sought on testing for pesticides. By a 60-to-37 vote, a bipartisan measure introduced by Senator Barbara Boxer, Democrat of California, and a dozen others would place a one-year moratorium on any government-sponsored testing programs on humans.
By a 57-to-40 vote, a measure sponsored by three Republicans, Senators Conrad Burns of Montana, Saxby Chambliss of Georgia and James M. Inhofe of Oklahoma, would require a review by third-party groups of all human testing programs conducted for the government, to identify and quantify their toxic effects. It also gives the E.P.A. six months to develop new regulations on pesticide testing.
By Michael Janofsky. New York Times.
June 28, 2005 EPA Proposal Would Allow Human Tests Of Pesticides
Draft Rule Omits Some Recommended Safeguards
By Juliet Eilperin
The Washington Post
June 16, 2005 EPA ENCOURAGING PESTICIDE COMPANIES TO CONDUCT HUMAN STUDIES — Proposed New Rules Lack Any Ethical Protections for Study Subjects

Public Employees for Environmental Responsibility (PEER)

May 9, 2005 PEER's submission to US EPA re: Human Testing; Proposed Plan and Description of Review Process

Federal Register
Docket No. OPP-2003-0132

Public Employees for Environmental Responsibility (PEER)

Feb 8, 2005

US EPA: Human Testing; Proposed Plan and Description of Review Process

Docket No. OPP-2003-0132

Federal Register

pages 6661 - 6667



Full report: Intentional Human Dosing Studies for EPA Reguatory Purposes: Scientific and Ethical Issues.

ISBN: 0-309-09172-1, 226 pages

National Research Council,
Committee on the Use of Third Party Toxicity Research with Human Research Participants Science.

The US EPA CHEERS Study in Duval County, Florida

Overview of CHEERS

Media reports and documents

A US EPA "Children's Environmental Exposure Research Study" (CHEERS) was approved to assess children's exposure to pesticides in Jacksonville, Duval County, Florida. The two-year study was designed to monitor developmental changes in babies, from birth to age 3, who are exposed to pesticides in their homes.

This study was cancelled in April 2005. According to a report in the New York Times:

Stephen L. Johnson, the acting administrator of the Environmental Protection Agency, said on Friday that he was canceling a study of the effects of pesticides on infants and babies, a day after two Democratic senators said they would block his confirmation if the research continued...

Included in the pesticides and chemicals that were to be monitored were the fluorinated pesticides:

BifenthrinFipronilLambda-cyhalothrinCyfluthrin I, II, III, IV, total;

and the fluorinated chemicals:

4-fluoro-3-phenoxybenzoic acid and the perfluorinated PFOS and PFOA.


• To learn why their workers were becoming ill on the job, DuPont conducted human experiments with Teflon-laced cigarettes. Nine out of ten volunteers who smoked 0.4 milligrams of Teflon developed “Polymer Fume Fever”.
Ref: Clayton JW. 1967. Fluorocarbon toxicity and biological action. In Fluorine Chemistry Reviews. 1(2),197-252.

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