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 UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

 WASHINGTON, D.C. 20460 

OFFICE OF 

PREVENTION, PESTICIDES AND 

 TOXIC SUBSTANCES

December 5, 2008

MEMORANDUM 

SUBJECT: Ethics Review of Anti-Fouling Paint Study 

TO: Timothy Leighton 

 Antimicrobial Division 

FROM: Kelly Sherman 

 Human Research Ethics Reviewer 

 Office of Pesticide Programs 

REF: Anderson, I., Sherratt, R. (2005) Cruiser Uno: Determination of Dermal and 

Inhalation Exposure to Hazardous Substances During Amateur Use of Yacht 

Anti-Fouling Coatings. Unpublished study prepared by Inveresk under Study No. 

683732. 132 p. (MRID 46511801) 

 

I have reviewed the referenced document and determined that all applicable requirements 

of EPA’s Rule for the Protection of Human Subjects of Research (40 CFR Part 26) have been 

satisfied. 

Summary Characteristics of the Research 

In this research, 15 subjects applied copper-based antifouling paint to yachts using 

brushes and rollers, and 5 subjects wet-sanded the surface of a yacht previously treated with 

antifouling paint. Subjects wore whole body outer and inner dosimeters and personal air 

sampling pumps for monitoring dermal and inhalation exposure. The research was conducted in 

March 2004 at Port Edgar Marina, South Queensferry, Scotland. 
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1. Value of the Research to Society: The purpose of this study was to monitor and 

quantify copper exposure levels to “amateurs” (people who do not work on yachts or 

other water craft for their occupation) during application or sanding of anti-fouling paint 

on yachts. The study was funded by International Paint Limited. It contributes to the 

assessment of exposure due to applying and sanding anti-fouling paint on yachts and other 

similar types of water craft. 

2. Subject Selection: No information is provided about how the subjects were recruited or 

selected. The twenty subjects included 17 men and 3 women who ranged in age from 19 

to 77. The pregnancy and nursing status of the female subjects is not reported. There is 

no indication any subjects came from an especially vulnerable group. 

3. Risk-Benefit Ratio: Neither risks to the subjects nor actions taken to minimize those 

risks are reported. The report does not identify societal benefits of the research or how 

they would be distributed, or how the investigators weighed likely benefits of the 

research against the risks to individual subjects. 

4. Independent Ethics Review: The study does not report any independent ethics 

oversight or review of the protocol or of the conduct of the research. 

5. Informed Consent: The report states that each subject was provided with a full 

explanation of the study, its requirements, and potential risks, and signed a consent form 

prior to commencement of the research. 

6. Respect for Potential and Enrolled Subjects: There is no identifying information 

about any of the subjects in the report. It is not reported whether subjects were free to 

withdraw from the research.

Applicable Standards 

This research was initiated in March 2004, so the research occurred before the effective 

date of EPA’s amended Rule for the Protection of Human Subjects of Research on April 7, 2006. 

Because this research involved application of product provided by the sponsors at rates and 

under conditions specified by the investigators, it meets the definition of “research involving 

intentional exposure of a human subject” in the rule at 40 CFR §26.1102(i). 

The report of this research was submitted to EPA on March 30, 2005, before the effective 

date of EPA’s Amended Rule for the Protection of Human Subjects of Research, and thus it is 

not subject to the requirement of 40 CFR §26.1303 to document the ethical conduct of the 

research. 

 

The Agency’s rule defines standards that EPA must apply in deciding whether to rely on 

research—like this study—which may have involved intentional exposure of human subjects. 
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(See 40 CFR §26 subpart Q.) Because this study was initiated before the effective date of the 

rule, the applicable acceptance standards from 40 CFR §26 are these: 

§26.1703. Prohibition of reliance on research involving intentional exposure of 

human subjects who are pregnant women (and therefore their fetuses), nursing 

women, or children. Except as provided in §26.1706, in actions within the scope of 

§26.1701 EPA shall not rely on data from any research involving intentional exposure of 

any human subject who is a pregnant woman (and therefore her fetus), a nursing woman, 

or a child. 

§26.1704. Prohibition of reliance on unethical human research with nonpregnant 

adults conducted before April 7, 2006. Except as provided in §26.1706, in actions 

within the scope of §26.1701, EPA shall not rely on data from any research initiated 

before April 7, 2006, if there is clear and convincing evidence that the conduct of the 

research was fundamentally unethical (e.g., the research was intended to seriously harm 

participants or failed to obtain informed consent), or was significantly deficient relative 

to the ethical standards prevailing at the time the research was conducted. This 

prohibition is in addition to the prohibition in §26.1703. 

FIFRA §12(a)(2)(P) also applied to this research. This provision reads: 

In general, [i]t shall be unlawful for any person . . . to use any pesticide in tests on human 

beings unless such human beings (i) are fully informed of the nature and purposes of the 

test and of any physical and mental health consequences which are reasonably 

foreseeable therefrom, and (ii) freely volunteer to participate in the test. 

Compliance with Applicable Standards 

The twenty subjects in the study were all adults. The study is silent with respect to the 

pregnancy and nursing status of the three female subjects, but there is no indication that any of 

the subjects were pregnant or nursing women. In the absence of any information suggesting that 

pregnant or nursing women were among the subjects, the Agency’s interpretation is that reliance 

on the study is not prohibited by 40 CFR 26.1703. 

40 CFR §26.1704 forbids EPA to rely on data from pre-rule research—such as this 

study—if there is “clear and convincing evidence that the conduct of the research was 

fundamentally unethical..., or was significantly deficient relative to the ethical standards 

prevailing at the time the research was conducted.” Although there are significant gaps in the 

documentation of the ethical conduct of this research, these gaps do not in themselves amount to 

“clear and convincing evidence.” I found no evidence that this research was fundamentally 

unethical, or that its conduct was significantly deficient relative to standards prevailing when it 

was conducted. 40 CFR §26.1704 does not prohibit EPA reliance on this research. 
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FIFRA §12(a)(2)(P) requires that human subjects of research with pesticides be “fully 

informed of . . . any physical and mental health consequences which are reasonably foreseeable” 

from their participation in research. The reported descriptions of the consent process appear to 

meet the substantive requirements of FIFRA §12(a)(2)(P) for fully voluntary participation. 

Conclusion 

Although there are many significant gaps in the documentation of the ethical conduct of 

this study, there is no clear evidence that the research was intended to harm participants, or that 

it was fundamentally unethical in other ways. Deficient documentation does not itself constitute 

evidence that the ethical conduct of this study was deficient relative to standards prevailing when 

it was conducted. 

I find no barrier in law or regulation to reliance on MRID 46511801 in actions taken 

under FIFRA or §408 of FFDCA. I defer to others for a full review of the scientific validity of 

this study. If it were determined not to have scientific validity, it would also not be ethically 

acceptable.