Regulatory Developments

Amendments to Human Subject Regs Proposed by EPA

The EPA has proposed a set of amendments to regulations governing the protection of human research subjects. These regulations at 40 Code of Federal Regulations (CFR) Part 26 comprise multiple subparts that can be divided into two groups—Subpart A is the Common Rule federal agencies have adopted to ensure the protection of human subjects involved in research; the second group comprises nine additional subparts promulgated by the EPA specifically to address research involving human subjects conducted or sponsored by the EPA or submitted to the EPA for regulatory purposes.

The proposal seeks to harmonize the EPA-specific regulations with revisions to the Common Rule to resolve discrepancies. The major proposed revision affects Subpart K—Basic Ethical Requirements for Third-Party Human Research for Pesticides Involving Intentional Exposure of Nonpregnant, Nonnursing Adults.

The Common Rule

In 1991, fifteen federal departments and agencies, including the EPA, adopted the Common Rule, which was intended to create a uniform body of regulations across the federal government for the protection of human subjects involved in research. The Common Rule regulations were subsequently promulgated into each federal department or agency’s own set of regulations; these regulations are implemented and enforced at the individual department or agency level. Subsequently, all Common Rule agencies adopted revisions to the rule, most recently in 2017 to “modernize, strengthen, and make [the Common Rule] more effective.” The 2017 revisions take effect January 21, 2019.

EPA’s Regulations

The EPA promulgated its separate set of subparts in 2006 in response to a congressional mandate that banned the Agency from using certain appropriated funds until it issued a rule addressing reliance on third-party intentional dosing human toxicity studies for pesticides. Among the subparts are B through D, which prohibit any EPA-conducted or EPA-sponsored research involving intentional exposure to any substance of human subjects who are children or pregnant or nursing women. Subparts K through Q govern third-party pesticide research and the EPA’s reliance on research involving intentional exposure of human subjects. As noted, Subpart K extended the Common Rule provisions to third-party human research involving intentional exposure of nonpregnant, nonnursing adults relevant to pesticide regulatory decision-making.

The proposed revisions would apply to Subparts C, D, K, and M.

Subparts C and D

These two proposed revisions would update the EPA’s regulations to match changes that were made to the Common Rule. The changes involve certain activities that are exempt from the Common Rule and an update that clarifies that the Common Rule does not affect any state or local laws or regulations and particularly tribal law passed by the official governing body of an American Indian or Alaska Native tribe.

Absent the exemptions, the types of studies addressed by the regulations would be greatly complicated while providing no commensurate benefit to subjects, says the Agency.

Subpart K

The proposed revisions here are also intended to ensure harmonization with the Common Rule and, furthermore, are based on the EPA’s belief that it is appropriate for third-party research to be held to ethical standards that are equivalent to standards for research conducted or supported by the EPA. The proposed revisions would:

  • Add a statement to clarify and confirm that the option to obtain broad consent for the limited purposes of storage, maintenance, and secondary research use of identifiable private information or identifiable biospecimens is not a replacement for obtaining full informed consent for the primary research involving intentional exposure of a human subject that is subject to Subpart K.
  • Add a new paragraph clarifying that research initiated before the effective date of the final rule would be subject to the standards of the EPA’s regulations that were in effect at the time the research was initiated. The intent here is to avoid retrospective application of newer regulatory requirements.

The final amendment, which affects Subpart M, would correct a typographical error.

The EPA’s proposal was published in the December 6, 2018, Federal Register (FR).