10538 Federal Register / Vol. 78, No. 31 / Thursday, February 14, 2013 / Rules and Regulations 

(2) * * * 

(iv) Prior to accessing a child’s or 

parent’s public benefits or insurance for 

the first time, and after providing 

notification to the child’s parents 

consistent with paragraph (d)(2)(v) of 

this section, must obtain written, 

parental consent that— 

(A) Meets the requirements of § 99.30 

of this title and § 300.622, which 

consent must specify the personally 

identifiable information that may be 

disclosed (e.g., records or information 

about the services that may be provided 

to a particular child), the purpose of the 

disclosure (e.g., billing for services 

under part 300), and the agency to 

which the disclosure may be made (e.g., 

the State’s public benefits or insurance 

program (e.g., Medicaid)); and 

(B) Specifies that the parent 

understands and agrees that the public 

agency may access the parent’s or 

child’s public benefits or insurance to 

pay for services under part 300. 

(v) Prior to accessing a child’s or 

parent’s public benefits or insurance for 

the first time, and annually thereafter, 

must provide written notification, 

consistent with § 300.503(c), to the 

child’s parents, that includes— 

(A) A statement of the parental 

consent provisions in paragraphs 

(d)(2)(iv)(A) and (B) of this section; 

(B) A statement of the ‘‘no cost’’ 

provisions in paragraphs (d)(2)(i) 

through (iii) of this section; 

(C) A statement that the parents have 

the right under 34 CFR part 99 and part 

300 to withdraw their consent to 

disclosure of their child’s personally 

identifiable information to the agency 

responsible for the administration of the 

State’s public benefits or insurance 

program (e.g., Medicaid) at any time; 

and 

(D) A statement that the withdrawal of 

consent or refusal to provide consent 

under 34 CFR part 99 and part 300 to 

disclose personally identifiable 

information to the agency responsible 

for the administration of the State’s 

public benefits or insurance program 

(e.g., Medicaid) does not relieve the 

public agency of its responsibility to 

ensure that all required services are 

provided at no cost to the parents. 

* * * * * 

[FR Doc. 2013–03443 Filed 2–13–13; 8:45 am] 

BILLING CODE 4000–01–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 26 

[EPA–HQ–OPP–2010–0785; FRL–9353–4] 

RIN 2070–AJ76 

Protections for Subjects in Human 

Research Involving Pesticides 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: 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 thirdparty 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. 

DATES: This rule is effective April 15, 

2013. 

ADDRESSES: 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. 

FOR FURTHER INFORMATION CONTACT: 

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. 

SUPPLEMENTARY INFORMATION: 

I. Executive Summary 

A. Does this action apply to me? 

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. 

B. What action is the agency taking? 

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 

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Federal Register / Vol. 78, No. 31 / Thursday, February 14, 2013 / Rules and Regulations 10539 

laws, 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 the definition of 

‘‘pesticide’’ from FIFRA, as a substance 

or mixture of substances intended for 

pesticidal effect. 

• By deleting from 40 CFR part 26, 

subpart K, all references to consent on 

behalf of a subject in research involving 

intentional exposure to a pesticide by a 

subject’s ‘‘legally authorized 

representative.’’ 

• 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. 

C. What is the agency’s authority for 

taking this action? 

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. 

D. What are the incremental costs and 

benefits of this action? 

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. 

II. Background 

A. EPA’s 2006 Rule 

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 (‘‘firstparty’’) 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. 

B. Petition for Review of the 2006 Rule 

and Settlement Agreement 

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. 

C. Proposed Amendments to the 2006 

EPA Rule 

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). 

D. Retrospective Review of the Common 

Rule 

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). 

III. The Final Rule 

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 

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10540 Federal Register / Vol. 78, No. 31 / Thursday, February 14, 2013 / Rules and Regulations 

§§ 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.’’ 

IV. Public Comments on the Proposed 

Amendments 

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. 

A. Comments on Proposal To Expand 

Scope To Include Research Submitted to 

EPA Under Any Regulatory Statute EPA 

Administers 

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. 

After considering these comments, 

EPA has decided to finalize the rule text 

relating to scope as it was proposed, i.e., 

expanding the scope to cover research 

involving intentional exposure of 

human subjects to pesticides where that 

research is submitted, or intended to be 

submitted, to EPA under any regulatory 

statute that EPA administers. As noted 

in EPA’s Response to Comments 

document, EPA no longer regards the 

2006 Appropriations Act as authority 

for this rule. Therefore, EPA believes it 

is unnecessary to address whether the 

2006 Appropriation Act either requires 

or does not allow EPA to establish a 

different scope for this rule. 

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. 

B. Comments on Inclusion of NASDerived Considerations 

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 

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Federal Register / Vol. 78, No. 31 / Thursday, February 14, 2013 / Rules and Regulations 10541 

is 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. 

C. Other Comments, Including 

Comments on Narrowing the Scope of 

the 2006 Rule To Include Only 

Intentional Dosing Studies 

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. 

V. Conclusion 

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. 

VI. Statutory and Executive Order 

Reviews 

A. Executive Order 12866: Regulatory 

Planning and Review and Executive 

Order 13563: Improving Regulation and 

Regulatory Review 

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. 

B. Paperwork Reduction Act (PRA) 

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. 

In its 2008 analysis supporting the 

most recent renewal of this ICR, EPA 

estimated that respondents would 

submit to the Agency some 34 proposals 

for or reports of research involving 

intentional exposure of human subjects 

each year. EPA estimated that 

preparation of information required by 

the 2006 rule would require about 598 

hours per study at a cost of $45,927 per 

study, for a total estimated annual 

burden for affected entities of 20,332 

hours at an estimated cost of $1,561,518. 

In addition, EPA estimated annual 

submission of 20 reports of research 

requiring only documentation of ethical 

conduct at a cost of 12 hours/$879 per 

report, or 240 hours/$17,580 per year. 

The total estimate of the annual 

respondent burden and cost was the 

sum of these two estimates, or 2,572 

hours/$1,579,098. 

These paperwork burden and cost 

estimates include activities related to 

initial rule familiarization, as well as 

activities that researchers would have to 

perform even without the Agency’s 

rulemaking in this area, such as 

developing a protocol and maintaining 

records. 

The average annual burden on EPA 

for reviewing each of the 34 study 

submissions was estimated to be 178 

hours/$16,850 per study, or 6,052 

hours/$572,900 per year. The average 

annual burden on EPA for reviewing 

each of the 20 additional submissions 

was estimated to be 44 hours/$3,158 per 

study, or 880 hours/$63,160 per year. 

The total estimate of the annual burden 

on EPA was the sum of these two 

estimates, or 6,932 hours/$636,000 per 

year. 

In no year since promulgation of the 

2006 rule have more than 7 protocols 

been submitted to EPA by industry; the 

average annual rate has been just over 

5 for the 5-year period of 2006–2010. 

Somewhat fewer completed reports 

have been submitted during this period, 

so the average of new protocols and 

finished studies has been about 11 per 

year, less than a third of the projected 

34 per year covered by the ICR. There 

is no evidence to suggest an upward 

trend, and nothing in these amendments 

is believed likely to lead to a significant 

change in the rate of protocol and study 

submissions. 

An agency may not conduct or 

sponsor, and a person is not required to 

respond to, a collection of information 

unless it displays a currently valid OMB 

control number. The OMB control 

numbers for EPA’s regulations in 40 

CFR are listed in 40 CFR part 9. 

C. Regulatory Flexibility Act (RFA) 

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, 

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10542 Federal Register / Vol. 78, No. 31 / Thursday, February 14, 2013 / Rules and Regulations 

small organizations, and small 

governmental jurisdictions. 

For purposes of assessing the impacts 

of this rule on small entities, small 

entity is defined as: 

1. A small business as defined by the 

Small Business Administration’s (SBA) 

regulations at 13 CFR 121.201, which is 

based on either the maximum number of 

employees or on the sales for small 

businesses in each industry sector, as 

defined by a 6-digit NAICS code, and for 

this rule is pesticide and other 

agricultural chemical manufacturers 

(NAICS code 325320) who sponsor or 

conduct human research with 

pesticides, or other entities (NAICS code 

541710) that sponsor or conduct human 

research with pesticides, and IRBs who 

review human research with pesticides 

to ensure it meets applicable standards 

of ethical conduct; 

2. A small governmental jurisdiction 

that is a government of a city, county, 

town, school district, or special district 

with a population of less than 50,000; or 

3. A small organization that is any 

not-for-profit enterprise which is 

independently owned and operated and 

is not dominant in its field. 

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. 

D. Unfunded Mandates Reform Act 

(UMRA) 

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. 

E. Executive Order 13132: Federalism 

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. 

F. Executive Order 13175: Consultation 

and Coordination With Indian Tribal 

Governments 

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. 

G. Executive Order 13045: Protection of 

Children From Environmental Health 

Risks and Safety Risks 

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. 

H. Executive Order 13211: Actions 

Concerning Regulations That 

Significantly Affect Energy Supply, 

Distribution, or Use 

This action is not a ‘‘significant 

regulatory action’’ as defined in 

Executive Order 13211 (66 FR 28355, 

May 22, 2001), because it is not likely 

to have a significant adverse effect on 

the supply, distribution, or use of 

energy. 

I. National Technology Transfer and 

Advancement Act (NTTAA) 

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. 

J. Executive Order 12898: Federal 

Actions To Address Environmental 

Justice in Minority Populations and 

Low-Income Populations 

Executive Order 12898 (59 FR 7629, 

February 16, 1994) establishes Federal 

executive policy on environmental 

justice. Its main provision directs 

Federal agencies, to the greatest extent 

practicable and permitted by law, to 

make environmental justice part of their 

mission by identifying and addressing, 

as appropriate, disproportionately high 

and adverse human health or 

environmental effects of their programs, 

policies, and activities on minority 

populations and low-income 

populations in the United States. 

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. 

VII. Congressional Review Act 

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 

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Federal Register / Vol. 78, No. 31 / Thursday, February 14, 2013 / Rules and Regulations 10543 

report 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). 

List of Subjects in 40 CFR Part 26 

Environmental protection, 

Administrative practice and procedures, 

Human research, Pesticides and pests. 

Dated: February 8, 2013. 

Lisa P. Jackson, 

Administrator. 

Therefore, 40 CFR chapter I is 

amended as follows: 

PART 26—[AMENDED] 

■ 1. The authority citation for part 26 is 

revised to read as follows: 

Authority: 5 U.S.C. 301; 7 U.S.C. 136a(a) 

and 136w(a)(1); 21 U.S.C. 346a(e)(1)(C); sec. 

201, Pub. L. 109–54, 119 Stat. 531; and 42 

U.S.C. 300v–1(b). 

■ 2. In § 26.1101: 

■ a. Remove paragraphs (a), (c), and (g). 

■ b. Redesignate paragraph (b) as (c), (f) 

as (g), (e) as (f), and (d) as (e). 

■ c. Add new paragraphs (a), (b), and 

(d). 

The amendments read as follows: 

§ 26.1101 To what does this subpart 

apply? 

(a) Except as provided in paragraph 

(c) of this section, this subpart applies 

to all research initiated on or after April 

15, 2013 involving intentional exposure 

of a human subject to: 

(1) Any substance if, at any time prior 

to initiating such research, any person 

who conducted or supported such 

research intended either to submit 

results of the research to EPA for 

consideration in connection with any 

action that may be performed by EPA 

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 to hold 

the results of the research for later 

inspection by EPA under FIFRA or 

section 408 of FFDCA; or 

(2) A pesticide if, at any time prior to 

initiating such research, any person who 

conducted or supported such research 

intended either to submit results of the 

research to EPA for consideration in 

connection with any action that may be 

performed by EPA under any regulatory 

statute administered by EPA other than 

those statutes designated in paragraph 

(a)(1) of this section, or to hold the 

results of the research for later 

inspection by EPA under any regulatory 

statute administered by EPA other than 

those statutes designated in paragraph 

(a)(1) of this section. 

(b) For purposes of determining a 

person’s intent under paragraph (a) of 

this section, EPA may consider any 

available and relevant information. EPA 

must rebuttably presume the existence 

of intent if: 

(1) The person or the person’s agent 

has submitted or made available for 

inspection the results of such research 

to EPA; or 

(2) The person is a member of a class 

of people who, or whose products or 

activities, are regulated by EPA and, at 

the time the research was initiated, the 

results of such research would be 

relevant to EPA’s exercise of its 

regulatory authority with respect to that 

class of people, products, or activities. 

* * * * * 

(d) The EPA Administrator retains 

final judgment as to whether a 

particular activity is covered by this 

subpart. 

* * * * * 

■ 3. In § 26.1102, revise paragraphs (a) 

and (c) and add new paragraph (k) to 

read as follows: 

§ 26.1102 Definitions. 

(a) Administrator means the 

Administrator of the Environmental 

Protection Agency (EPA) and any other 

officer or employee of EPA to whom 

authority has been delegated. 

* * * * * 

(c) Pesticide means any substance or 

mixture of substances meeting the 

definition in 7 U.S.C. 136(u) (Federal 

Insecticide, Fungicide, and Rodenticide 

Act, section 2(u)). 

* * * * * 

(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. 

§ 26.1111 [Amended] 

■ 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: 

§ 26.1116 General requirements for 

informed consent. 

No investigator may involve a human 

being as a subject in research covered by 

this subpart unless the investigator has 

obtained the legally effective informed 

consent of the subject. An investigator 

must seek such consent only under 

circumstances that provide the 

prospective subject sufficient 

opportunity to consider whether or not 

to participate and that minimize the 

possibility of coercion or undue 

influence. The information that is given 

to the subject must be in language 

understandable to the subject. No 

informed consent, whether oral or 

written, may include any exculpatory 

language through which the subject is 

made to waive or appear to waive any 

of the subject’s legal rights, or releases 

or appears to release the investigator, 

the sponsor, the institution or its agents 

from liability for negligence. 

* * * * * 

■ 6. Revise § 26.1117 to read as follows: 

§ 26.1117 Documentation of informed 

consent. 

(a) Informed consent must be 

documented by the use of a written 

consent form approved by the IRB and 

signed by the subject. A copy shall be 

given to the subject. 

(b) The consent form may be either of 

the following: 

(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 

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10544 Federal Register / Vol. 78, No. 31 / Thursday, February 14, 2013 / Rules and Regulations 

be given to the subject, in addition to a 

copy of the short form. 

■ 7. Revise the heading for subpart L to 

read as follows: 

Subpart L—Prohibition of Third-Party 

Research Involving Intentional 

Exposure to a Pesticide of Human 

Subjects Who Are Children or 

Pregnant or Nursing Women 

■ 8. Revise § 26.1201 to read as follows: 

§ 26.1201 To what does this subpart 

apply? 

This subpart applies to any research 

subject to subpart K of this part. 

■ 9. Revise § 26.1301 to read as follows: 

§ 26.1301 To what does this subpart 

apply? 

This subpart applies to any person 

who submits to EPA on or after April 

15, 2013 either of the following: 

(a) A report containing the results of 

any human research for consideration in 

connection with an action that may be 

performed by EPA under FIFRA (7 

U.S.C. 136–136y) or section 408 of 

FFDCA (21 U.S.C. 346a). 

(b) A report containing the results of 

any human research on or with a 

pesticide for consideration in 

connection with any action that may be 

performed by EPA under any regulatory 

statute administered by EPA. 

§ 26.1302 [Amended] 

■ 10. In § 26.1302, remove the word 

‘‘shall.’’ 

§ 26.1502 [Amended] 

■ 11. In § 26.1502: 

■ a. Remove in the first sentence of 

paragraph (a), the period after the 

phrase ‘‘during an inspection’’ and add 

in its place a comma. 

■ b. Remove in the second sentence of 

paragraph (a), the phrase ‘‘The agency’’ 

and add in its place ‘‘EPA.’’ 

■ c. Remove in the last sentence of the 

introductory text of paragraph (b), the 

phrase ‘‘the Agency’’ and add in its 

place ‘‘EPA.’’ 

§ 26.1505 [Amended] 

■ 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 [Amended] 

■ 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 To what does this subpart 

apply? 

This subpart applies to both of the 

following: 

(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 Definitions. 

The definitions in § 26.1102 also 

apply to this subpart. 

■ 16. In newly redesignated § 26.1603: 

■ a. Remove paragraphs (a) and (e). 

■ b. Redesignate paragraphs (b) through 

(d) as (e) through (g). 

■ c. Add new paragraphs (a), (b), (c), (d), 

and (h). 

The amendments read as follows: 

§ 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: 

(1) Whether the research would be 

likely to produce data that address an 

important scientific or policy question 

that cannot be resolved on the basis of 

animal data or human observational 

research. 

(2) Whether the proposed research is 

designed in accordance with current 

scientific standards and practices to: 

(i) Address the research question. 

(ii) Include representative study 

populations for the endpoint in 

question. 

(iii) Have adequate statistical power to 

detect appropriate effects. 

(3) Whether the investigator proposes 

to conduct the research in accordance 

with recognized good research practices, 

including, when appropriate, good 

clinical practice guidelines and 

monitoring for the safety of subjects. 

(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: 

(1) Whether adequate information is 

available from prior animal studies or 

from other sources to assess the 

potential risks to subjects in the 

proposed research. 

(2) Whether the research proposal 

adequately identifies anticipated risks to 

human subjects and their likelihood of 

occurrence, minimizes identified risks 

to human subjects, and identifies likely 

benefits of the research and their 

distribution. 

(3) Whether the proposed research 

presents an acceptable balance of risks 

and benefits. In making this 

determination for research intended to 

reduce the interspecies uncertainty 

factor in a pesticide risk assessment, the 

EPA Administrator will also consider 

the process laid out and the attendant 

discussion for evaluating that type of 

study as provided in Recommendation 

4–1 of the 2004 Report from the 

National Research Council of the 

National Academy of Sciences (NAS), 

entitled ‘‘Intentional Human Dosing 

Studies for EPA Regulatory Purposes: 

Scientific and Ethical Issues.’’ 

(4) Whether subject selection will be 

equitable. 

(5) Whether subjects’ participation 

would follow free and fully informed 

consent. 

(6) Whether an appropriately 

constituted IRB or its foreign equivalent 

has approved the proposed research. 

(7) If any person from a vulnerable 

population may become a subject in the 

proposed research, whether there is a 

convincing justification for selection of 

such a person, and whether measures 

taken to protect such human subjects 

are adequate. 

(8) If any person with a condition that 

would put them at increased risk for 

adverse effects may become a subject in 

the proposed research, whether there is 

a convincing justification for selection 

of such a person, and whether measures 

taken to protect such human subjects 

are adequate. 

(9) Whether any proposed payments 

to subjects are consistent with the 

principles of justice and respect for 

persons, and whether they are so high 

as to constitute undue inducement or so 

low as to be attractive only to 

individuals who are socioeconomically 

disadvantaged. 

(10) Whether the sponsor or 

investigator would provide needed 

medical care for injuries incurred in the 

proposed research, without cost to the 

human subjects. 

(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 

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Administrator, are necessary for the 

protection of human subjects. 

* * * * * 

(h) EPA must provide the submitter of 

the proposal copies of the EPA and 

Human Studies Review Board reviews. 

■ 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. 

In commenting on reports of 

completed research submitted to it by 

EPA, the Human Studies Review Board 

must consider the scientific merits and 

ethical aspects of the completed 

research, and must apply the 

appropriate standards in subpart Q of 

this part. 

■ 19. Revise the heading for subpart Q 

to read as follows: 

Subpart Q—Standards for Assessing 

Whether To Rely on the Results of 

Human Research in EPA Actions 

■ 20. Revise §§ 26.1701 through 26.1705 

to read as follows: 

* * * * * 

Sec. 

26.1701 To what does this subpart apply? 

26.1702 Definitions. 

26.1703 Prohibitions applying to all 

research subject to this subpart. 

26.1704 Prohibition of reliance on unethical 

human research with non-pregnant, nonnursing adults. 

26.1705 Prohibition of reliance on unethical 

human research with non-pregnant, nonnursing adults initiated after April 7, 

2006. 

* * * * * 

§ 26.1701 To what does this subpart 

apply? 

(a) For decisions under FIFRA (7 

U.S.C. 136–136y) or section 408 of 

FFDCA (21 U.S.C. 346a), this subpart 

applies to research involving intentional 

exposure of human subjects to any 

substance. 

(b) For decisions under any regulatory 

statute administered by EPA other than 

those statutes designated in paragraph 

(a) of this section, this subpart applies 

to research involving intentional 

exposure of human subjects to a 

pesticide. 

§ 26.1702 Definitions. 

The definitions in § 26.1102 and 

§ 26.1202 also apply to this subpart. 

§ 26.1703 Prohibitions applying to all 

research subject to this subpart. 

(a) Prohibition of reliance on 

scientifically invalid research. EPA 

must not rely on data from research 

subject to this subpart unless EPA 

determines that the data are relevant to 

a scientific or policy question important 

for EPA decisionmaking, that the data 

were derived in a manner that makes 

them scientifically valid and reliable, 

and that it is appropriate to use the data 

for the purpose proposed by EPA. In 

making such determinations, EPA must 

consider: 

(1) Whether the research was 

designed and conducted in accordance 

with appropriate scientific standards 

and practices prevailing at the time the 

research was conducted. 

(2) The extent to which the research 

subjects are representative of the 

populations for the endpoint or 

endpoints in question. 

(3) The statistical power of the data to 

support the scientific conclusion EPA 

intends to draw from the data. 

(4) In a study that reports only a No 

Observed Effect Level (NOEL) or a No 

Observed Adverse Effect Level 

(NOAEL), whether a dose level in the 

study gave rise to a biological effect, 

thereby demonstrating that the study 

had adequate sensitivity to detect an 

effect of interest. 

(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 Prohibition of reliance on 

unethical human research with nonpregnant, non-nursing adults. 

(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: 

(1) 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 

(2) The conduct of the research was 

deficient relative to the ethical 

standards prevailing at the time the 

research was conducted in a way that 

placed participants at increased risk of 

harm (based on knowledge available at 

the time the study was conducted) or 

impaired their informed consent. 

(c) The prohibition in this section is 

in addition to the prohibitions in 

§ 26.1703. 

§ 26.1705 Prohibition of reliance on 

unethical human research with nonpregnant, non-nursing adults initiated after 

April 7, 2006. 

(a) This section applies to research 

subject to this subpart, that: 

(1) Was initiated after April 7, 2006. 

(2) Was subject, at the time it was 

conducted, either to subparts A through 

L of this part, or to the codification of 

the Common Rule by another Federal 

department or agency. 

(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: 

(1) All applicable provisions of 

subparts A through L of this part, or the 

codification of the Common Rule by 

another Federal department or agency; 

or 

(2) If the research was conducted 

outside the United States, with 

procedures at least as protective of 

subjects as those in subparts A through 

L of this part, or the codification of the 

Common Rule by another Federal 

department or agency. 

(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 

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10546 Federal Register / Vol. 78, No. 31 / Thursday, February 14, 2013 / Rules and Regulations 

1Areas designated as mandatory Class I Federal 

areas consist of national parks exceeding 6000 

acres, wilderness areas and national memorial parks 

exceeding 5000 acres, and all international parks 

that were in existence on August 7, 1977. 42 U.S.C. 

7472(a). In accordance with section 169A of the 

Clean Air Act, EPA, in consultation with the 

Department of Interior, promulgated a list of 156 

areas where visibility is identified as an important 

value. 44 FR 69122 (November 30, 1979). The 

extent of a mandatory Class I area includes 

subsequent changes in boundaries, such as park 

expansions. 42 U.S.C. 7472(a). Although states and 

tribes may designate as Class I additional areas 

which they consider to have visibility as an 

important value, the requirements of the visibility 

program set forth in section 169A of the Clean Air 

Act apply only to ‘‘mandatory Class I Federal 

areas.’’ Each mandatory Class I Federal area is the 

responsibility of a ‘‘Federal Land Manager.’’ 42 

U.S.C. 7602(i). When we use the term ‘‘Class I area’’ 

in this action, we mean a ‘‘mandatory Class I 

Federal area.’’ 

study 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 [Amended] 

■ 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] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 52 

[EPA–R10–OAR–2011–0367; FRL–9756–8] 

Approval and Promulgation of 

Implementation Plans; State of Alaska; 

Regional Haze State Implementation 

Plan 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: EPA is approving a State 

Implementation Plan (SIP) submittal 

from the State of Alaska as meeting the 

requirements of Clean Air Act (CAA) 

sections169A and 169B and federal 

regional haze regulations. The SIP 

implements a regional haze program in 

the State of Alaska for the first regional 

haze planning period, through July 31, 

2018. This submittal addresses the 

requirements of the Clean Air Act (CAA) 

and EPA’s rules that require states to 

prevent any future and remedy any 

existing manmade impairment of 

visibility in mandatory Class I areas 

caused by emissions of air pollutants 

from numerous sources located over a 

wide geographic area (also referred to as 

the ‘‘regional haze program’’). In this 

action, EPA is approving all provisions 

of Alaska’s Regional Haze SIP 

submission, including the requirements 

for the calculation of baseline and 

natural visibility conditions, statewide 

inventory of visibility-impairing 

pollutants, best available retrofit 

technology (BART), Reasonable Progress 

Goals (RPGs), and Long-Term Strategy 

(LTS). Additionally, EPA is approving 

the Alaska Department of 

Environmental Conservation Best 

Available Retrofit Technology 

regulations, and amendments to 

Alaska’s Area Wide Pollution Control 

Program for Regional Haze. 

DATES: This final rule is effective March 

18, 2013. 

ADDRESSES: EPA has established a 

docket for this action under Docket ID 

No. EPA–R10–OAR–2011–0367. All 

documents in the docket are listed on 

the www.regulations.gov Web site. 

Although listed in the index, some 

information is not publicly available, 

e.g., Confidential Business Information 

(CBI) or other information whose 

disclosure is restricted by statute. 

Certain other material, such as 

copyrighted material, is not placed on 

the Internet and will be publicly 

available only in hard copy form. 

Publicly available docket materials are 

available either electronically through 

www.regulations.gov or in hard copy at 

the State and Tribal Air Programs Unit, 

Office of Air Waste and Toxics, EPA 

Region 10, 1200 Sixth Avenue, Seattle, 

WA 98101. EPA requests that if at all 

possible, you contact the individual 

listed in the FOR FURTHER INFORMATION

CONTACT section to view the hard copy 

of the docket. You may view the hard 

copy of the docket Monday through 

Friday, 8:00 a.m. to 4:00 p.m., excluding 

Federal holidays. 

FOR FURTHER INFORMATION CONTACT: 

Keith Rose, EPA Region 10, Suite 900, 

Office of Air, Waste and Toxics, 1200 

Sixth Avenue, Seattle, WA 98101, (206) 

553–1949. 

SUPPLEMENTARY INFORMATION: 

Definitions 

For the purpose of this document, we 

are giving meaning to certain words or 

initials as follows: 

(i) The words or initials Act, CAA, or 

Clean Air Act mean or refer to the Clean 

Air Act, unless the context indicates 

otherwise. 

(ii) The words EPA, we, us or our 

mean or refer to the United States 

Environmental Protection Agency. 

(iii) The initials SIP mean or refer to 

State Implementation Plan. 

(iv) The words Alaska and State mean 

the State of Alaska. 

Table of Contents 

I. Background Information 

II. Response to Comments 

III. Final Action 

IV. Statutory and Executive Orders Review 

I. Background Information 

In the CAA Amendments of 1977, 

Congress established a program to 

protect and improve visibility in the 

national parks and wilderness areas. See 

CAA section 169A. Congress amended 

the visibility provisions in the CAA in 

1990 to focus attention on the problem 

of regional haze. See CAA section 169B. 

EPA promulgated regulations in 1999 to 

implement sections 169A and 169B of 

the Act. These regulations require states 

to develop and implement plans to 

ensure reasonable progress toward 

improving visibility in mandatory Class 

I Federal areas 1 (Class I areas). 64 FR 

35714 (July 1, 1999); see also 70 FR 

39104 (July 6, 2005) and 71 FR 60612 

(October 13, 2006). 

On February 24, 2012, EPA published 

a Notice of Proposed Rulemaking (NPR) 

for the State of Alaska. See 77 FR 11022. 

In the NPR, EPA proposed approval of 

the Alaska SIP submittal that addresses 

regional haze for the planning period 

2008 through 2018. The Regional Haze 

Plan was submitted to EPA on April 4, 

2011. Specifically, EPA proposed to 

approve all provisions of Alaska’s April 

4, 2011 Regional Haze SIP submission. 

In this action, EPA is approving all 

provisions of Alaska’s Regional Haze 

SIP submission, including the 

requirements for the calculation of 

baseline and natural visibility 

conditions, statewide inventory of 

visibility-impairing pollutants, best 

available retrofit technology (BART), 

Reasonable Progress Goals (RPGs), LongTerm Strategy (LTS), ADEC’s BART 

regulations in 18 AAC 50.260, and the 

amendments to 18 AAC 50.030 which 

adopts by reference Volume II, Section 

III. F. Open Burning; Volume II, Section 

III. K. Area Wide Pollution Control 

Program for Regional Haze; and Volume 

II, Appendices to Volume II. 

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