90. Environmental Protection Agency (EPA) Regulations for Human Research
Updated September 28, 2023
Federal Regulations for EPA Research Involving Human Participants
The EPA has adopted the Common Rule under 40 CFR 26 Subpart A §26.101-124: Basic EPA Policy for Protection of Subjects in Human Research Conducted or Supported by EPA. Order 1000.17A, Policy and Procedures on Protection of Human Subjects in EPA Conducted or Supported Research (updated on 09/29/2022) further codifies EPA requirements for the protection of human research participants in research conducted or supported by EPA.
EPA Subparts B, C, D, K, L, M, and Q describe prohibitions involving the intentional exposure of a pregnant or nursing woman or child in research conducted or supported by EPA; prohibitions of relying on the results of said research; and criteria and procedures for the EPA to rely on otherwise unacceptable data. See the specific subparts listed below for details.
Subpart B §26.201-203: Prohibition of Research Conducted or Supported by EPA Involving Intentional Exposure of Human Subjects Who Are Children or Pregnant or Nursing Women
Subpart C §26.301-305: Observational Research: Additional Protections for Pregnant Women and Fetuses Involved as Subjects in Observational Research Conducted or Supported by EPA
Subpart D §26.401-406: Observational Research: Additional Protections for Children Involved as Subjects in Observational Research Conducted or Supported by EPA
Subpart K §26.1101-1125: Basic Ethical Requirements for Third-party Human Research for Pesticides Involving Intentional Exposure of Non-pregnant, Non-nursing Adults
Subpart L §26.1201-1203: Prohibition of Third-party Research Involving Intentional Exposure to a Pesticide of Human Subjects Who Are Children or Pregnant or Nursing Women
Subpart M §26.1301-1303: Requirements for Submission of Information on the Ethical Conduct of Completed Human Research
Subpart Q §26.1701-1706: Standards for Assessing Whether to Rely on the Results of Human Research in EPA Actions
Additional EPA Requirements for IRB Review and Approval
In addition to the Common Rule, University IRBs will comply with the following additional requirements before approving research invoking EPA regulations.
- The IRB will not approve research involving intentional exposure of pregnant women or children to any substance. This includes research not yet submitted to the EPA.
- The IRB will review and approve observational research involving pregnant women and fetuses only if the IRB finds and documents that the research is consistent with 45 CFR 46 Subpart B (for details, see IRB policy for research involving pregnant women and fetuses).
- The IRB will review and approve observational EPA research involving children that does not involve greater than minimal risk only if the IRB finds and documents that the research is consistent with 45 CFR 46 Subpart D and that adequate provisions are made for soliciting the assent of the children and the permission of their parents or guardians (see IRB policy for research involving children for information about permission and assent requirements).
- The IRB will review and approve observational EPA research involving children that poses greater than minimal risk only if the IRB finds and documents that:
- the research is consistent with 45 CFR 46 Subpart D, including adequate provisions to obtain parent permission and child assent,
- the intervention or procedure holds out the prospect of direct benefit to the individual participant or is likely to contribute to the participant’s well-being,
- the risk is justified by the anticipated benefit to the participants, and
- risk-to-benefit ratio of the research is at least as favorable to the participants as that of available alternative approaches.
Additional Requirement for EPA Review and Approval Following IRB Approval
Per the EPA regulations at 40 CFR 26, after obtaining IRB approval and before initiating human research subject to EPA regulations at §26.1101(a), investigators must submit to EPA the information required at §26.1125.
EPA Order 1000.17A further specifies that all human subjects research conducted or supported by EPA must either be approved or be acknowledged as exempt research by the EPA Human Subjects Research Review Official (HSRRO) before any work involving human subjects research can begin. To obtain approval of human subject research by the HSRRO, researchers must submit all materials submitted to the IRB, documentation of the approval or exemption, and any correspondence between the IRB and the researchers to the EPA Program Official.
To verify compliance with this requirement, the UNR IRB will issue Conditional Approval for studies subject to EPA requirements when all UNR IRB requirements for approval have been met, and request confirmation of HSRRO approval as a condition for granting full Approval. The Conditional Approval letter will include the following instructions:
“All human subjects research conducted or supported by EPA must either be approved or be acknowledged as exempt research by the EPA Human Subjects Research Review Official (HSRRO) before any work involving human subjects research can begin. To obtain approval of human subject research by the HSRRO, researchers must submit all materials submitted to the IRB, documentation of the approval or exemption, and any correspondence between the IRB and the researchers to the EPA Program Official. Please see the EPA General Terms and Conditions (Human Subjects section) in effect at the time of the award for more information. Documentation of EPA HSRRO approval must be forwarded to Research Integrity prior to engaging with human subjects, including recruitment.”
EPA Prohibitions for Human Research
Research conducted or supported by EPA, or intended for submission to the EPA, the University IRB recognizes that research involving the intentional exposure of pregnant women or children is prohibited and will not approve such research. This prohibition extends to intentional exposure by third parties on behalf of the University and to research not conducted or supported a federal agency.
Additional Requirements for Human Research Involving Intentional Exposure to Pesticides
NOTE: The following applies to intentional exposure by third parties on behalf of the University and to research not conducted or supported a federal agency.
Unless the research is exempt under Department of Health and Human Services (DHHS) regulations (45 CFR 46.104, EPA requirements a §26.1101 (i.e., Subpart K) apply to research involving intentional exposure of non-pregnant, non-nursing adults that was initiated on or after April 15, 2013, to:
- any substance* if the person who conducted or supported the research intended either to submit results to EPA or hold the results for later EPA inspection by EPA for consideration of an EPA action under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) (7 U.S.C. 136-136y) or section 408 of the Federal Food, Drug, and Cosmetic Act (FFDCA) (21 U.S.C. 346a); or
- a pesticide if the person who conducted or supported the research intended either to submit results to EPA or hold the results for later EPA inspection by EPA for consideration in connection with any EPA-regulated action other than FIFRA or section 408 of FFDCA.
The IRB and EPA may consider any available and relevant information to assess a person's intent as described above. The existence of intent will be presumed if the person conducting or supporting the research, or her/his agent:
- has submitted or made available for inspection the results of such research to EPA; or
- is a member of a class of people who, or whose products or activities, are regulated by EPA and the results of the research would be relevant to EPA's regulatory authority?
University and Affiliate investigators must also comply with applicable foreign laws/regulations providing additional protections to human research participants and the Nevada Pesticide Act (NRS Chapter 586). The Act includes requirements for registration of brands of pesticides which are or will be distributed, sold or offered for sale within Nevada, or delivered for transportation or transported in intrastate commerce or between points within Nevada through any point outside Nevada.
Additional EPA Requirements for Submission of Information to EPA for Completed Research
After completing research subject to EPA regulations for human research, investigators must comply with EPA regulations at §26.1303 by providing the EPA with the following information (when not previously provided to the EPA):
- Copies of all records relevant to the research (e.g., IRB applications; scientific evaluations, if any; approved sample consent documents; progress and problem reports, and IRB approvals.
- Copies of all of records relevant to the requirement for EPA approval following IRB approval (at §26.1125).
For three years following the closure of the research project, investigators and the IRB will maintain the records as specified in §26.1115, item (a).
NOTE: If any of this information is not provided, the PI must describe the efforts made to obtain the information.