Source: https://www.federalregister.gov/documents/2013/02/14/2013-03456/protections-for-subjects-in-human-research-involving-pesticides
Timestamp: 2020-01-19 17:03:17
Document Index: 563766031

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Federal Register :: Protections for Subjects in Human Research Involving Pesticides
A Rule by the Environmental Protection Agency on 02/14/2013
This rule is effective April 15, 2013.
78 FR 10538
10538-10546 (9 pages)
FRL-9353-4
A. EPA's 2006 Rule
B. Petition for Review of the 2006 Rule and Settlement Agreement
C. Proposed Amendments to the 2006 EPA Rule
D. Retrospective Review of the Common Rule
IV. Public Comments on the Proposed Amendments
A. Comments on Proposal To Expand Scope To Include Research Submitted to EPA Under Any Regulatory Statute EPA Administers
B. Comments on Inclusion of NAS-Derived Considerations
C. Other Comments, Including Comments on Narrowing the Scope of the 2006 Rule To Include Only Intentional Dosing Studies
https://www.federalregister.gov/d/2013-03456 https://www.federalregister.gov/d/2013-03456
EPA is finalizing narrowly tailored amendments to the portions of its rules for the protection of human subjects of research applying to third parties who conduct or support research with pesticides involving intentional exposure of human subjects and to persons who submit the results of human research with pesticides to EPA. The amendments broaden the applicability of the rules to cover human testing with pesticides submitted to EPA under any regulatory statute it administers. The amendments also disallow participation in third-party pesticide studies by subjects who cannot consent for themselves. Finally, the amendments identify specific considerations to be addressed in EPA science and ethics reviews of proposed and completed human research with pesticides, drawn from the recommendations of the National Academy of Sciences (NAS). The amendments make no changes to the current Federal Policy for the Protection of Human Subjects (the “Common Rule”), which governs research with human subjects conducted or supported by EPA and many other Federal departments and agencies.
The docket for this action, identified by docket identification (ID) number EPA-HQ-OPP-2010-0785, is available at http://www.regulations.gov or at the OPP Docket in the Environmental Protection Agency Docket Center (EPA/DC), located in the EPA West Bldg., Rm. 3334, 1301 Constitution Ave. NW., Washington, DC 20460-0001. The Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The telephone number for the Public Reading Room is (202) 566-1744, and the telephone number for the OPP Docket is (703) 305-5805. Please review the visitor instructions and additional information about the docket available at http://www.epa.gov/​dockets.
Kelly Sherman, Immediate Office of the Director (7501P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone number: (703) 305-8401; fax number: (703) 308-4776; email address: sherman.kelly@epa.gov.
You may be potentially affected by this action if you conduct or sponsor research that may be submitted to EPA and which involves intentional exposure of human subjects. The following list of North American Industrial Classification System (NAICS) codes is not intended to be exhaustive, but rather provides a guide to help readers determine whether this document might apply to them. Although EPA has in the past received such third-party research from pesticide registrants, other entities could submit such information to EPA.
Pesticide and other Agricultural Chemical Manufacturing (NAICS code 325320) who sponsor or conduct human research with pesticides.
Other entities (NAICS code 541710) that sponsor or conduct human research with pesticides, and Institutional Review Boards (IRBs) who review human research with pesticides to ensure it meets applicable standards of ethical conduct. Under these new provisions, EPA must consider the ethical aspects and scientific validity and reliability of research in a manner that is consistent with the requirements of the Common Rule as codified in 40 CFR part 26, subpart A. The “Common Rule” is the name generally used to refer to the Federal Policy for the Protection of Human Subjects, which governs research with human subjects conducted or supported by EPA and many other Federal departments and agencies. EPA's codification of the Common Rule appears as subpart A in 40 CFR part 26.
The amendments contained in this final rule change the 2006 rule, published in the Federal Register issue of February 6, 2006 (71 FR 6138) (FRL-7759-8), subsequently amended in the Federal Register issue of June 23, 2006 (71 FR 36171) (FRL-8071-6), and codified at 40 CFR part 26, in the following substantive respects:
By broadening the applicability of 40 CFR part 26, subparts K, L, M, and Q, so these subparts would apply not only to research submitted to or considered by EPA under the pesticide Start Printed Page 10539laws, but also to research involving a “pesticide” (as defined in the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) (7 U.S.C. 136(u)) which is submitted to or considered by EPA under any other regulatory statute it administers.
By incorporating into 40 CFR part 26, subparts P and Q, factors to be considered by EPA and the Human Studies Review Board (HSRB), in their review of proposed and completed human research, derived from the recommendations by the National Research Council of NAS in its 2004 Report entitled “Intentional Human Dosing Studies for EPA Regulatory Purposes: Scientific and Ethical Issues” (hereafter, 2004 NAS Report) to EPA.
Sections 3(a) and 25(a) of FIFRA (7 U.S.C. 136a(a) and 136w(a)) and section 408(e)(1)(C) of the Federal Food, Drug, and Cosmetic Act (FFDCA) (21 U.S.C. 364a(e)(1)(C)), provide the legal authority for these amendments to the 2006 rule on human research.
The incremental costs of these amendments both to industry and to EPA are expected to be negligible. EPA has not, therefore, prepared a new economic analysis for this rule. Because no research has been identified that is outside the scope of the 2006 rule but that would be within the scope of these amendments, EPA has no basis on which to revise the cost estimates that were provided in the economic analysis for the 2006 rule or those most recently provided in the 2008 renewal of the Information Collection Request (ICR) for the existing regulation at 40 CFR part 26. The estimates included in the ICR are summarized in Unit VI.B. and a copy of the ICR is available in the docket.
As required by section 201 of the Department of the Interior, Environment, and Related Agencies Appropriations Act, 2006 (2006 Appropriations Act), Public Law 109-54, 119 Stat. 531, EPA promulgated a rule in 2006 establishing a set of protections for people participating as subjects in third-party human research with pesticides in 40 CFR part 26. (In this context “third-party” research is research neither conducted (“first-party”) nor supported (“second-party”) by EPA or another Common Rule Federal department or agency.) The 2006 rule prohibits EPA from relying on third-party research on pesticides involving intentional exposure of children or of pregnant or nursing women, unless relying on the data is crucial to a decision that would impose a more stringent regulatory restriction that would improve protection of public health than could be justified without relying on the data. It further forbids EPA itself to conduct or support any research involving intentional exposure of pregnant or nursing women or of children to any substance.
In early 2006, the Natural Resources Defense Council, Inc.; Pesticide Action Network North American; Pineros y Campesinos Unido Del Noroeste; Physicians for Social Responsibility-San Francisco; Farm Labor Organizing Committee; ALF-CIO; and Migrant Clinicians Network petitioned for review of the 2006 rule in the United States Court of Appeals for the Second Circuit (Second Circuit Court of Appeals) (NRDC v. EPA, No. 06-0820-ag (2d Cir.)). The Petitioners argued that the 2006 rule violated the 2006 Appropriations Act because it did not bar all pesticide research with pregnant women and children, was inconsistent with the 2004 NAS Report, and was inconsistent with the Nuremburg Code.
After briefing and argument, but before a decision was rendered by the Second Circuit Court of Appeals, EPA and Petitioners entered a settlement agreement in which EPA agreed to conduct notice-and-comment rulemaking on the issue of whether the 2006 rule should be amended. EPA also agreed to propose, at a minimum, amendments to the 2006 rule that were substantially consistent with language negotiated between the parties and attached to the settlement agreement as Exhibit A. This agreement, including Exhibit A, is available in the docket for this action as described under ADDRESSES. The settlement agreement makes clear that EPA retained full discretion concerning what amendments were proposed, and what, if any, amendments are finalized.
Consistent with the settlement agreement, on January 18, 2011, EPA Administrator Lisa Jackson signed a notice of proposed rulemaking for proposed amendments to the 2006 rule. The proposed amendments were substantially consistent with the regulatory language negotiated with Petitioners. The notice of proposed rulemaking published in the Federal Register issue of February 2, 2011 (76 FR 5735) (FRL-8862-7).
On July 26, 2011, after issuance of EPA's proposed rule, the Department of Health and Human Services (HHS), in coordination with the Office of Science and Technology Policy (OSTP), issued an advance notice of proposed rulemaking concerning modernization of the Common Rule which governs research with human subjects conducted or supported by EPA and many other Federal departments and agencies (76 FR 44512, July 26, 2011). HHS and OSTP sought comment on “how to better protect human subjects who are involved in research, while facilitating valuable research and reducing burden, delay, and ambiguity for investigators.” Id. HHS and OSTP identified seven areas of concern regarding the Common Rule. Most relevant to EPA's proposed amendments to the 2006 rule, was a concern with “the multiple, differing regulatory requirements that can apply to a single research study * * * .” These requirements, according to HHS and OSTP, “have been criticized as complex, inconsistent, and lacking in clarity,” and can result in “unwarranted variability across institutions and their [Institutional Review Boards] in how the requirements are interpreted and implemented” (76 FR at 45514). HHS and OSTP stressed the importance of clarifying and harmonizing human subject protections across the Federal Government and sought comment on the means by which this could be accomplished (76 FR at 44528).
EPA is finalizing the amendments to the 2006 rule as proposed. This includes changes to the scope and consent provisions, and the incorporation of selected individual recommendations from the 2004 NAS Report as the specific ethical and scientific factors to be considered by EPA and the HSRB in reviewing proposed and completed human research (i.e., proposed Start Printed Page 10540§§ 26.1603 and 26.1703, see 76 FR 5745-5749).
The amendments finalized in this rule are consistent with the recommendations in the 2004 NAS Report and EPA practice under the 2006 rule. That practice has been modeled primarily on EPA's practice under its Common Rule. Sections 26.109, 26.111, 26.116, and 26.117 of EPA's Common Rule explicitly address most of the specific ethical considerations included in the amendments to the 2006 rule, including whether risks to subjects are minimized (compare § 26.1603(c)(2) with existing § 26.111(a)(2)); whether risks are reasonable in comparison to benefits (compare § 26.1603(c)(3) with § 26.111(a)(2)); whether subject selection would be equitable (compare § 26.1603(c)(4) with existing § 26.111(a)(3)); whether consent will be free and voluntary (compare § 26.1603(c)(5) with existing §§ 26.116 and 26.117); whether an appropriately constituted institutional review board (IRB) has reviewed the proposed research (compare § 26.1603(c)(6) with § 26.109); and whether the “special problems” of research involving vulnerable populations are taken into account (compare § 26.1603(c)(7) and (8) with existing § 26.111(a)(3)). Other considerations are implicitly addressed.
The Common Rule's requirement to “minimize risks” in § 26.111(a)(1) necessitates consideration of whether adequate animal data is available to assess potential risks to subjects (see § 26.1603(c)(1)). It would involve consideration of whether medical care is to be provided for injuries incurred in the proposed research (see § 26.1603(c)(10)). Section 26.111(b)'s requirement that additional safeguards be in place to protect against undue influence of “economically” disadvantaged persons ensures that consideration of whether any proposed payments are so high as to constitute undue inducement or so low as to be attractive only to individuals who are socioeconomically disadvantaged (see § 26.1603(c)(9)). Although scientific considerations are not addressed in similar detail in the Common Rule requirements, nonetheless, the requirement to consider scientific validity and reliability and the Common Rule's emphasis on the need for “sound research design” in § 26.111(a)(1) and the need to take “the importance of the knowledge that may reasonably be expected to result” from the study into account, mandate that EPA focus on considerations addressing scientific validity such as those included in §§ 26.1603 and 26.1703. At a minimum, NAS Recommendations 3-1, 4-1, 5-1, 5-2, 5-3, and 5-5 are critical to proper consideration of the Common Rule's ethical requirements and its requirement for “sound research design.”
This unit discusses, in general terms, the public comments on the proposed amendments and EPA's responses to those comments. EPA received a total of 10 public comments on the proposed amendments during the 60-day comment period. Comments were submitted by 4 individual citizens and 6 different entities—the Agricultural Handler Exposure Task Force, the American Chemistry Council (on behalf of the Antimicrobial Exposure Assessment Task Force II), Beyond Pesticides, CropLife America, Natural Resources Defense Council, and SC Johnson & Son, Inc. The docket (under docket ID number EPA-HQ-OPP-2010-0785) includes all of the comments submitted to EPA on the proposed amendments, as well as EPA's Response to Comments document, which provides detailed responses to all comments received.
Two comments addressed the proposed changes to the scope of the 2006 rule. One commenter stated that the 2006 Appropriations Act did not permit an expansion of scope beyond pesticide studies performed in the FIFRA and FFDCA context, and another argued that the 2006 Appropriations Act required that the scope of the rule be further expanded beyond studies submitted, or intended for submission, to EPA.
Nevertheless, EPA regards FIFRA as providing adequate legal authority for the scope of research covered by this final rule. Sections 3(a) and 25(a) of FIFRA provide EPA with authority to regulate pesticides, including research involving intentional exposure of a human subject to a substance, when the substance is being tested as a “pesticide.” That includes research intended for submission to EPA, whether under FIFRA, FFDCA, or any of EPA's other regulatory authorities. EPA believes it makes sense to apply the same standards to all human studies involving pesticides submitted to EPA. On the other hand, EPA believes that it is not in the public interest to extend the prohibition against research involving intentional exposure of children or pregnant women to pesticides beyond the scope delineated in the proposed rule because such a prohibition, if enforceable, could have the unintended effect of prohibiting valuable research.
Two commenters questioned whether new regulatory text proposed at § 26.1603(b)(2)(ii) and (iii) would change the ways in which EPA has been reviewing proposed studies to measure exposures experienced by people who mix, load, or apply pesticides. As proposed, EPA would have been required to consider whether the proposed research includes representative study populations for the endpoint in question and has adequate statistical power to detect appropriate effects. These commenters expressed the same concern regarding the proposed regulatory text at § 26.1703(a)(2) and (3), which would require EPA to consider these factors in determining whether to rely on the research. As explained in more detail in EPA's Response to Comments document, EPA does not believe that the adoption of the specific ethical and scientific factors will impose any additional burden on sponsors of exposure studies or on the types of exposure studies referenced by the commenters.
As explained previously, EPA has decided to finalize the proposed text detailing specific scientific and ethical aspects of proposed and completed research—including the text proposed at § 26.1603(b)(2)(ii) and (iii) and at § 26.1703(a)(2) and (3)—that EPA and the HSRB must consider when reviewing such research. EPA also notes that, under the 2006 rule as amended through this final rule, EPA does not intend to change the way in which it reviews exposure research with respect to the inclusion of representative populations or the statistical power of the study, although EPA will consider whether further guidance on this issue Start Printed Page 10541is needed. In addition, EPA does not believe the codification of the specific ethical and scientific factors derived from the 2004 NAS Report represents a material change in the way a particular pesticide study would have been reviewed. Thus, EPA believes that particular pesticides studies that have been approved under the 2006 rule, would also meet the standards reflected in this final rule.
The remainder of the public comments addressed issues beyond the scope of the proposed amendments. These comments included arguments that the burden of the requirements of the 2006 rule (as opposed to any burden connected to this amendment) are unjustified, and assertions that EPA's interpretation in the 2006 rule of the language “research involving intentional exposure of a human subject” incorrectly expanded the scope of the rule beyond that required in the 2006 Appropriations Act, which addressed only “intentional dosing human toxicity studies.” The commenters are referring to § 26.1101(a) of the 2006 rule, which defines the scope of the rule as applying to “all research initiated after April 7, 2006 involving intentional exposure of a human subject * * *.” As EPA explained in the preamble to the proposal for the 2006 rule, this scope was intended to capture “all intentional dosing human studies intended for submission to EPA under the pesticide laws”, i.e., studies involving intentional dosing to measure a toxic effect and studies involving intentional dosing to measure other scientific endpoints, like exposure (Federal Register issue of September 12, 2005 (70 FR at 53845) (FRL-7728-2)). Additional discussion in the preambles to the proposal for the 2006 rule and 2006 rule further explains what studies EPA intended to be included within the scope of the 2006 rule (70 FR at 53845-53847; 71 FR 6138, 6146, 6149-6150).
Because these comments were directed at provisions in the 2006 rule that EPA did not reopen for reconsideration as part of the proposed amendments, these comments are beyond the scope of this final rule, and no response to them is required to finalize this rule. Nonetheless, EPA appreciates the concerns expressed by the commenters with regard to the burdens imposed by the 2006 rule and recognizes that there may be value in considering further amendments to the 2006 rule in a way that reduces the burdens on investigators, e.g., by limiting the types of research that are subject to particular requirements of the rule.
EPA received relatively few comments on the proposed rule, and many of the comments received did not address the amendments in the proposal. For the reasons noted previously, the comments that did address the proposal do not merit any change to the amendments as proposed. Accordingly, EPA is finalizing the amendments as proposed for the reasons stated herein and in the preamble to the proposed rule.
Under Executive Order 12866 (58 FR 51735, October 4, 1993), this action is a “significant regulatory action,” because the Office of Management and Budget (OMB) determined that it would raise novel legal or policy issues arising out of legal mandates, the President's priorities, or the principles set forth in the Executive Order. Accordingly, EPA submitted this action to OMB for review under Executive Orders 12866 and 13563 (76 FR 3821, January 21, 2011). Any changes made in response to OMB recommendations have been documented in the docket for this rulemaking as required by the Executive Order.
This action does not impose any new information collection burden that would require additional review or approval by OMB. However, OMB has previously approved the information collection requirements contained in the existing regulations at 40 CFR part 26 under the provisions of PRA (44 U.S.C. 3501 et seq.), and has assigned OMB Control No. 2070-0169 (EPA ICR No. 2195). The OMB control numbers for EPA's regulations in 40 CFR are listed in 40 CFR part 9.
RFA (5 U.S.C. 601 et seq.), generally requires an agency to prepare a regulatory flexibility analysis of any rule subject to notice and comment rulemaking requirements under the Administrative Procedure Act (5 U.S.C. 551-553) or any other statute unless the agency certifies that the rule will not have a significant economic impact on a substantial number of small entities. Small entities include small businesses, Start Printed Page 10542small organizations, and small governmental jurisdictions.
After considering the economic impacts of this final rule on small entities, I certify that this action will not have a significant economic impact on a substantial number of small entities. Because no small entities have been identified that are directly regulated by these amendments, EPA has not attempted to reduce the impact of this final rule on small entities. Public comments were explicitly invited on all aspects of the proposal and its impacts on small entities, but no such comments were received.
Title II of UMRA (2 U.S.C. 1531-1538) establishes requirements for Federal agencies to assess the effects of their regulatory actions on State, local, and tribal governments and the private sector. This rule does not contain a Federal mandate that may result in expenditures of $100 million or more for State, local, and tribal governments, in the aggregate, or the private sector in any 1 year. Thus, this rule is not subject to the requirements of UMRA sections 202 or 205. This rule is also not subject to the requirements of UMRA section 203, because it contains no regulatory requirements that might significantly or uniquely affect small governments. These amendments are unlikely to affect State, local, and tribal governments at all, and are likely to affect the private sector only trivially.
This action does not have federalism implications because it will not have substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132 (64 FR 43255, August 10, 1999). It makes marginal changes in the scope of an existing rule applying to sponsors and investigators conducting certain kinds of research involving human subjects, and refines the standards for EPA oversight of and reliance on such research. Thus, Executive Order 13132 does not apply to this action.
This action does not have tribal implications as specified in Executive Order 13175 (65 FR 67249, November 9, 2000). This action will not have substantial direct effects on Indian Tribes, will not significantly or uniquely affect the communities of Indian tribal governments, and does not involve or impose any requirements that affect Indian Tribes. Thus, Executive Order 13175 does not apply to this action.
EPA interprets Executive Order 13045 (62 FR 19885, April 23, 1997), as applying only to those regulatory actions that concern health or safety risks, such that the analysis required under section 5-501 of the Executive Order has the potential to influence the regulation. This action is not subject to Executive Order 13045, because it does not establish an environmental standard intended to mitigate health or safety risks, nor is it an “economically significant regulatory action” as defined in Executive Order 12866. The 2006 rule applies to the conduct and review of research involving intentional exposure of human subjects, and prohibits the conduct of or EPA reliance on any such research involving subjects who are children, or pregnant or nursing women. These provisions would not be affected by the amendments.
Section 12(d) of NTTAA (15 U.S.C. 272 note) directs EPA to use voluntary consensus standards in its regulatory activities unless to do so would be inconsistent with applicable law or otherwise impractical. Voluntary consensus standards are technical standards (e.g., materials specifications, test methods, sampling procedures, and business practices) that are developed or adopted by voluntary consensus standards bodies. NTTAA directs EPA to provide Congress, through OMB, explanations when the Agency decides not to use available and applicable voluntary consensus standards. This action does not involve any technical standards. Therefore, EPA did not consider the use of any voluntary consensus standards.
EPA has determined that this final rule will not have disproportionately high and adverse human health or environmental effects on minority or low-income populations, because it does not affect the level of protection provided to human health or the environment. This rule does not entail special considerations of environmental justice related issues. The strengthened protections for human subjects participating in covered research established in the 2006 rule will not be altered by these amendments.
The Congressional Review Act (5 U.S.C. 801 et seq.), generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and the Comptroller General of the United States. EPA will submit a Start Printed Page 10543report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of the rule in the Federal Register. A major rule cannot take effect until 60 days after it is published in the Federal Register. This action is not a “major rule” as defined by 5 U.S.C. 804(2).
2. In § 26.1101:
3. In § 26.1102, revise paragraphs (a) and (c) and add new paragraph (k) to read as follows:
(k) Common Rule refers to the Federal Policy for the Protection of Human Subjects that was established in 1991 by the Office of Science and Technology Policy and codified in 1991 by EPA and 14 other Federal departments and agencies (see the Federal Register issue of June 18, 1991 (56 FR 28003)) and subsequently codified by other Federal departments and agencies. The Common Rule contains a widely accepted set of standards for conducting ethical research with human subjects, together with a set of procedures designed to ensure that the standards are met. Once codified by a Federal department or agency, the requirements of the Common Rule apply to research conducted or sponsored by that Federal department or agency. EPA's codification of the Common Rule appears in 40 CFR part 26, subpart A.
4. In § 26.1111, remove from paragraph (a)(4) the phrase “or the subject's legally authorized representative.”
5. In § 26.1116, revise the introductory text of the section to read as follows:
6. Revise § 26.1117 to read as follows:
(1) A written consent document that embodies the elements of informed consent required by § 26.1116. This form may be read to the subject, but in any event, the investigator must give the subject adequate opportunity to read it before it is signed; or
(2) A short form written consent document stating that the elements of informed consent required by § 26.1116 have been presented orally to the subject. When this method is used, there must be a witness to the oral presentation. Also, the IRB shall approve a written summary of what is to be said to the subject. Only the short form itself is to be signed by the subject. However, the witness must sign both the short form and a copy of the summary, and the person actually obtaining consent must sign a copy of the summary. A copy of the summary must Start Printed Page 10544be given to the subject, in addition to a copy of the short form.
8. Revise § 26.1201 to read as follows:
§ 26.1201
9. Revise § 26.1301 to read as follows:
§ 26.1301
10. In § 26.1302, remove the word “shall.”
§ 26.1502
11. In § 26.1502:
§ 26.1505
12. In § 26.1505, remove from the last sentence, the citation “§ 26.1502(c)” and add in its place “§ 26.1502(b)(4).”
§ 26.1507
13. In § 26.1507, remove from the last sentence, the phrase “The Agency” and add in its place “EPA.”
§§ 26.1601 through 26.1603
[Redesignated as §§ 26.1603 through 26.1605]
14. Redesignate §§ 26.1601 through 26.1603 as §§ 26.1603 through 26.1605.
15. Add new §§ 26.1601 and 26.1602 to subpart P to read as follows:
§ 26.1601
(a) Reviews by EPA and by the Human Studies Review Board of proposals to conduct new research subject to § 26.1125.
(b) Reviews by EPA on or after April 15, 2013 and, to the extent required by § 26.1604, by the Human Studies Review Board of reports of completed research subject to § 26.1701.
§ 26.1602
The definitions in § 26.1102 also apply to this subpart.
16. In newly redesignated § 26.1603:
b. Redesignate paragraphs (b) through (d) as (e) through ( g).
§ 26.1603
EPA review of proposed human research.
(a) EPA must review all proposals for new human research submitted under § 26.1125 in a timely manner.
(b) In reviewing proposals for new human research submitted under § 26.1125, the EPA Administrator must consider and make determinations regarding the scientific validity and reliability of the proposed research, including:
(c) In reviewing proposals for new research submitted under § 26.1125, the EPA Administrator must consider and make determinations regarding ethical aspects of the proposed research, including:
(d) With respect to any research or any class of research subject to this subpart, the EPA Administrator may recommend additional conditions which, in the judgment of the EPA Start Printed Page 10545Administrator, are necessary for the protection of human subjects.
17. In newly redesignated § 26.1604, revise paragraph (a) to read as follows:
§ 26.1604
EPA review of completed human research.
(a) When considering, under any regulatory statute it administers, data from completed research involving intentional exposure of humans to a pesticide, EPA must thoroughly review the material submitted under § 26.1303, if any, and other available, relevant information and document its conclusions regarding the scientific and ethical conduct of the research.
18. Add §§ 26.1606 and 26.1607 to subpart P to read as follows:
§ 26.1606
Human Studies Review Board review of proposed human research.
In commenting on proposals for new research submitted to it by EPA, the Human Studies Review Board must consider the scientific merits and ethical aspects of the proposed research, including all elements required in § 26.1603(b) and (c) and any additional conditions recommended pursuant to § 26.1603(d).
§ 26.1607
Human Studies Review Board review of completed human research.
20. Revise §§ 26.1701 through 26.1705 to read as follows:
§ 26.1701
§ 26.1702
The definitions in § 26.1102 and § 26.1202 also apply to this subpart.
§ 26.1703
(b) Prohibition of reliance on research subject to this subpart involving intentional exposure of human subjects who are pregnant women (and therefore their fetuses), nursing women, or children. Except as provided in § 26.1706, EPA must not rely on data from any research subject to this subpart involving intentional exposure of any human subject who is a pregnant woman (and therefore her fetus), a nursing woman, or a child.
§ 26.1704
(a) This section applies to research subject to this subpart that is not subject to § 26.1705.
(b) Except as provided in § 26.1706, EPA must not rely on data from any research subject to this section if there is clear and convincing evidence that:
(c) The prohibition in this section is in addition to the prohibitions in § 26.1703.
§ 26.1705
(b) Except as provided in § 26.1706, EPA must not rely on data from any research subject to this section unless EPA determines that the research was conducted in substantial compliance with either:
(c) Except as provided in § 26.1706, EPA must not rely on data from any research subject to this section unless EPA determines that the research was conducted in substantial compliance with either:
(1) A proposal that was found to be acceptable under § 26.1603(c), and no amendments to or deviations from that proposal placed participants at increased risk of harm (based on knowledge available at the time the Start Printed Page 10546study was conducted) or impaired their informed consent. If EPA discovers that the submitter of the proposal materially misrepresented or knowingly omitted information that would have altered the outcome of EPA's evaluation of the proposal under § 26.1603(c), EPA must not rely on that data.
(2) A proposal that would have been found to be acceptable under § 26.1603(c), if it had been subject to review under that section, and no amendments to or deviations from that proposal placed participants at increased risk of harm (based on knowledge available at the time the study was conducted) or impaired their informed consent.
(d) The prohibition in this section is in addition to the prohibitions in § 26.1703.
§ 26.1706
21. In § 26.1706, remove in paragraph (d) the word “publishes” and add in its place the phrase “has published.”
[FR Doc. 2013-03456 Filed 2-13-13; 8:45 am]