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OPP Requirements for Pesticide Testing with Human Subjects
November 9, 1998 Disclaimer: "Links to Web sites outside the U.S. EPA Web site are for the convenience of the user. The Standards of Ethical Conduct do not permit the U.S. EPA to endorse any private sector Web site, product, or service. The U.S. EPA does not exercise any editorial control over the information you may find at this location. These links are being provided consistent with the intended purpose of the EPA Web site."
- Both were published before the EPA Common Rule,
- Both cite the rule issued by the Department of Health and Human
Services ( OPP
Requirements for Pesticide Testing with Human Subjects)
- Both cite Section 12(a)(2)(P) of the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA), which defines as an unlawful act "to use any pesticide in tests on human beings unless such human beings (i) are fully informed of the nature and purpose of the test..., and (ii) freely volunteer to participate...," and
- Both make reference to the need for approval of the research by "the appropriate human studies committee for the state" or "the appropriate institutional review board."
These guidelines are currently being reconsidered as part of OPP's efforts to harmonize its test guidelines with other countries, and the revised guidelines are expected to cite the EPA common rule (40 CFR Part 26) directly.
Extracts from
Pesticide Assessment Guidelines
Subdivision U
Applicator Exposure Monitoring
U.S. Environmental Protection Agency
Washington, DC
1987
A very important consideration that must be kept in mind when selecting methods for exposure monitoring is that the monitoring method should not subject the participants to any more exposure than is absolutely necessary. For instance, if the pesticide label specifies that respirators that have been approved by the National Institute for Occupational Safety and Health (NIOSH) must be worn during application, no method may require a participant to wear a respirator that would provide less protection. Every monitoring method must be chosen to ensure that human safety will not be compromised.
A very important consideration that must be kept in mind when selecting methods for exposure monitoring is that the monitoring method should not subject the participants to any more exposure than is absolutely necessary. For instance, if the pesticide label specifies that respirators that have been approved by the National Institute for Occupational Safety and Health (NIOSH) must be worn during application, no method may require a participant to wear a respirator that would provide less protection. Every monitoring method must be chosen to ensure that human safety will not be compromised.
A. Dermal exposure monitoring
- Monitoring of exposure to all areas of the body except the hands
The amount of pesticide potentially available for absorption through the skin of a worker can be estimated by trapping the material before it contacts the skin, or by removing material that has contacted the skin before it has been absorbed. This is done using various types of pads or articles of clothing to trap impinging residues, or by removing residues from the skin by swabbing or rinsing with an appropriate solvent....
§230 General Information and Exposure Methodology
Common to Sections 231 through 236
[...]
It cannot be overemphasized that investigations carried out according to these guidelines must be properly designed to provide for maximum protection of the study subject's health. Studies conducted to obtain human exposure data must not violate Section 12(a)(2)(P) of FIFRA. Informed consent should be obtained in writing from all subjects who will be exposed as a result of these studies, and proposed protocols may need to be approved by the appropriate human studies committee for the state in which the exposure will occur. Also, Guidelines for the Protection of Human Subjects of the Department of Health and Human Services should be considered for the design of such studies (Health and Human Services, 1981)
Proper administration is vital for successful exposure monitoring studies, as well as to ensure the safety of the workers being studied. It is most important that field studies have professional supervision by persons who are knowledgeable and experienced in exposure assessment. Investigators who are inexperienced are strongly urged to arrange to accompany an experienced investigator during an entire exposure study before attempting a study on their own.
All conditions specified on the label for legal application of registered pesticides must be observed. Existing or proposed labels with inappropriate information concerning protective clothing will be addressed on a case by case basis as protocols are submitted. Chemical resistant gloves, NIOSH approved respirators, or any other protective gear that is required, must not be removed during the exposure monitoring period. Also, any protective clothing and equipment required for the workers must not be altered in any manner that would result in decreased protection....
Extracts from
Pesticide Assessment Guidelines
Subdivision K
Exposure: Reentry Monitoring
U.S. Environmental Protection Agency
Washington, DC
1984
§133-2 Requirements for exposure data.
Scientific Advisory Panel (SAP)(a) Purpose and scope. (1) The purpose of this section is to delineate the requirements for developing and submitting data relating to human exposure for purposes of supporting reentry intervals proposed according to §134-2. The registration applicant should understand that useful exposure studies using surrogate chemicals-often other pesticides-may already exist and may be cited to meet the requirements of 40 CFR §158.140 discussed in this section; actual conduct of the study may be unnecessary if these data are cited. Therefore, the applicant should consult with the Agency before undertaking such studies. The submission and use of extant human exposure data on a surrogate pesticide is encouraged by the Agency and is acceptable if the registrant submits descriptions demonstrating that the sites and human activities for which the surrogate exposure data were obtained produce exposure which is greater than or substantially similar to those for which the reentry interval is being proposed.
(2) A registration applicant should not undertake or authorize development of information to meet the requirements of this section in such a manner as to pose a hazard to people assigned to perform activities in the study. The Guidelines for Protection of Human Subjects (40 CFR 46) promulgated by the U. S. Department of Health, Education, and Welfare contains information that should be considered for design of such studies. Before conducting any such studies, registration applicants should submit study protocols for approval by the appropriate institutional review board or public health department in states where the studies are to be performed.
(3) Any studies or monitoring conducted pursuant to this section must not violate FIFRA sec. 12(a)(2)(P) which provides that "...it shall be unlawful for any person in any State to use any pesticide in tests on human beings unless such human beings (i) are fully informed of the nature and purpose of the test....., and (ii) freely volunteer to participate in the test."
and Science Advisory Board (SAB) December 1998 Meeting