Federal Register / Vol. 86, No. 3 / Wednesday, January 6, 2021 / Rules and Regulations 469 

amount, instead of electing a direct 

rollover of the remaining account 

balance. 

(2) The amount of the distribution 

received by Employee A is $10,000 

($3,000 relating to the plan loan offset 

and $7,000 relating to the cash 

distribution). Because the amount of the 

$3,000 plan loan offset amount 

attributable to the loan is included in 

determining the amount of the eligible 

rollover distribution to which 

withholding applies, withholding in the 

amount of $2,000 (20 percent of 

$10,000) is required under section 

3405(c). The $2,000 is required to be 

withheld from the $7,000 to be 

distributed to Employee A in cash, so 

that Employee A actually receives a 

cash amount of $5,000. 

(3) The $3,000 plan loan offset 

amount is a qualified plan loan offset 

amount within the meaning of 

paragraph (a)(2)(iii)(B) of this section. 

Accordingly, Employee A may roll over 

up to the $3,000 qualified plan loan 

offset to an eligible retirement plan 

within the period that ends on the 

Employee A’s tax filing due date 

(including extensions) for the taxable 

year in which the offset occurs. In 

addition, Employee A may roll over up 

to $7,000 (the portion of the distribution 

that is not related to the offset) within 

the 60-day period provided in section 

402(c)(3). 

(E) Example 5. (1) The facts are the 

same as in paragraph (a)(2)(v)(D) of this 

section (Example 4), except that the 

$7,000 distribution to Employee A after 

the offset consists solely of employer 

securities within the meaning of section 

402(e)(4)(E). 

(2) No withholding is required under 

section 3405(c) because the distribution 

consists solely of the $3,000 plan loan 

offset amount and the $7,000 

distribution of employer securities. This 

is the result because the total amount 

required to be withheld does not exceed 

the sum of the cash and the fair market 

value of other property distributed, 

excluding plan loan offset amounts and 

employer securities. 

(3) Employee A may roll over up to 

the $7,000 of employer securities to an 

eligible retirement plan within the 60- 

day period provided in section 

402(c)(3). The $3,000 plan loan offset 

amount is a qualified plan loan offset 

amount within the meaning of 

paragraph (a)(2)(iii)(B) of this section. 

Accordingly, Employee A may roll over 

up to the $3,000 qualified plan loan 

offset amount to an eligible retirement 

plan within the period that ends on 

Employee A’s tax filing due date 

(including extensions) for the taxable 

year in which the offset occurs. 

(F) Example 6. (1) Employee B, who 

is age 40, has an account balance in Plan 

Z. Plan Z provides for no after-tax 

employee contributions. In 2022, 

Employee B receives a loan from Plan Z, 

the terms of which satisfy section 

72(p)(2), and which is secured by 

elective contributions subject to the 

distribution restrictions in section 

401(k)(2)(B). 

(2) Employee B fails to make an 

installment payment due on April 1, 

2023, or any other monthly payments 

thereafter. In accordance with § 1.72(p)– 

1, Q&A–10, Plan Z allows a cure period 

that continues until the last day of the 

calendar quarter following the quarter in 

which the required installment payment 

was due (September 30, 2023). 

Employee B does not make a plan loan 

installment payment during the cure 

period. On September 30, 2023, 

pursuant to section 72(p)(1), Employee 

B is taxed on a deemed distribution 

equal to the amount of the unpaid loan 

balance. Pursuant to § 1.402(c)–2, Q&A– 

4(d), the deemed distribution is not an 

eligible rollover distribution. 

(3) Because Employee B has not 

severed from employment or 

experienced any other event that 

permits the distribution under section 

401(k)(2)(B) of the elective contributions 

that secure the loan, Plan Z is 

prohibited from executing on the loan. 

Accordingly, Employee B’s account 

balance is not offset by the amount of 

the unpaid loan balance at the time of 

the deemed distribution. Thus, there is 

no distribution of an offset amount that 

is an eligible rollover distribution on 

September 30, 2023. 

(G) Example 7. (1) The facts are the 

same as in in paragraph (a)(2)(v)(F) of 

this section (Example 6), except that 

Employee B has a severance from 

employment on November 1, 2023. On 

that date, Employee B’s unpaid loan 

balance is offset against the account 

balance on distribution. 

(2) The plan loan offset amount is not 

a qualified plan loan offset amount. 

Although the offset occurred within 12 

months after Employee B severed from 

employment, the plan loan does not 

meet the requirement in paragraph 

(a)(2)(iii)(B) of this section (that the plan 

loan meet the requirements of section 

72(p)(2) immediately prior to Employee 

B’s severance from employment). 

Instead, the loan was taxable on 

September 30, 2023 (prior to Employee 

B’s severance from employment on 

November 1, 2023), because of the 

failure to meet the level amortization 

requirement in section 72(p)(2)(C). 

Accordingly, Employee B may roll over 

the plan loan offset amount to an 

eligible retirement plan within the 60- 

day period provided in section 

402(c)(3)(A) (rather than within the 

period that ends on Employee B’s tax 

filing due date (including extensions) 

for the taxable year in which the offset 

occurs). 

(b)(1) Q–2. When are the rules in this 

section applicable to plan loan offset 

amounts, including qualified plan loan 

offset amounts? 

(2) A–2. The rules provided in 

paragraph (a) of this section are 

applicable to plan loan offset amounts, 

including qualified plan loan offset 

amounts, treated as distributed on or 

after January 1, 2021. However, 

taxpayers (including a filer of a Form 

1099–R) may choose to apply the 

regulations in this section with respect 

to plan loan offset amounts, including 

qualified plan loan offset amounts, 

treated as distributed on or after August 

20, 2020. 

Sunita Lough, 

Deputy Commissioner for Services and 

Enforcement. 

Approved: December 1, 2020. 

David J. Kautter, 

Assistant Secretary of the Treasury (Tax 

Policy). 

[FR Doc. 2020–27151 Filed 1–5–21; 8:45 am] 

BILLING CODE 4830–01–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 30 

[EPA–HQ–OA–2018–0259; FRL–10019–07– 

ORD] 

RIN 2080–AA14 

Strengthening Transparency in Pivotal 

Science Underlying Significant 

Regulatory Actions and Influential 

Scientific Information 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This action establishes how 

the Environmental Protection Agency 

(EPA) will consider the availability of 

dose-response data underlying pivotal 

science used in its significant regulatory 

actions and influential scientific 

information. When promulgating 

significant regulatory actions or 

developing influential scientific 

information for which the conclusions 

are driven by the quantitative 

relationship between the amount of 

dose or exposure to a pollutant, 

contaminant, or substance and an effect, 

the EPA will give greater consideration 

to studies where the underlying doseVerDate Sep<11>2014 16:19 Jan 05, 2021 Jkt 253001 PO 00000 Frm 00031 Fmt 4700 Sfmt 4700 E:\FR\FM\06JAR1.SGM 06JAR1

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470 Federal Register / Vol. 86, No. 3 / Wednesday, January 6, 2021 / Rules and Regulations 

1Consistent with OMB guidance, this rule would 

not apply to the following regulatory actions: 

Individual party adjudications, enforcement 

activities, site-specific actions, or permit 

proceedings. 

response data are available in a manner 

sufficient for independent validation. 

This action also requires the EPA to 

identify and make publicly available the 

science that serves as the basis for 

informing a significant regulatory action 

at the proposed or draft stage to the 

extent practicable; reinforces the 

applicability of peer review 

requirements for pivotal science; and 

provides criteria for the Administrator 

to exempt certain studies from the 

requirements of this rulemaking. 

DATES: This final rule is effective on 

January 6, 2021. 

ADDRESSES: The EPA has established a 

docket for this action under Docket ID 

No. EPA–HQ–OA–2018–0259. All 

documents in the docket are listed on 

the http://www.regulations.gov website. 

Although listed in the index, some 

information is not publicly available, 

e.g., confidential business information 

(CBI) information 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 in the 

EPA Docket Center, WJC West Building, 

Room 3334, 1301 Constitution Avenue 

NW, Washington, DC 20004. The Docket 

Center’s hours are 8:30 a.m. to 4:30 

p.m., Monday through Friday (except 

Federal Holidays). Publicly available 

docket materials are available 

electronically through http://

www.regulations.gov. 

FOR FURTHER INFORMATION CONTACT: 

Bennett Thompson, Office of Science 

Advisor, Policy and Engagement 

(8104R), Environmental Protection 

Agency, 1200 Pennsylvania Ave. NW, 

Washington, DC 20460; telephone 

number: (202) 564–1071; email address: 

osp_staff@epa.gov. 

SUPPLEMENTARY INFORMATION: 

Table of Contents 

I. General Information 

A. Does this action apply to me? 

B. What action is the Agency taking? 

C. What is the Agency’s authority for 

taking this action? 

II. Background 

A. Summary of 2018 Proposed Rule 

B. Summary of 2020 Supplemental Notice 

of Proposed Rulemaking 

III. Description of Final Rule and Responses 

to Significant Comments 

A. Purpose and Effect of the Action 

1. Purpose 

2. Effect of This Rule on the Studies the 

EPA Uses To Support Significant 

Regulatory Actions and Influential 

Scientific Information 

3. Effect of This Rule on Human Health 

and Environmental Protection 

B. Dose-Response Data 

C. Definitions 

1. Capable of Being Substantially 

Reproduced, Independent Validation, 

and Reanalyze 

2. Data and Models 

3. Dose-Response Data 

4. Influential Scientific Information 

5. Pivotal Science 

6. Publicly Available 

7. Research Data 

8. Significant Regulatory Actions 

9. Science That Serves as the Basis for 

Informing a Significant Regulatory 

Action 

D. Applicability of the Rule 

E. Availability of Dose-Response Data 

F. Proposed 40 CFR 30.6 

G. Administrator’s Exemption 

H. Peer Review 

I. Changes to 40 CFR 30.4 ‘‘What 

requirements apply to EPA’s use of 

studies in significant regulatory 

actions?’’ 

J. Benefits and Costs 

K. Proposed 40 CFR 30.8 ‘‘How is EPA to 

account for cost under this subpart?’’ 

IV. References 

V. Statutory and Executive Orders Reviews 

A. Executive Order 12866: Regulatory 

Planning and Review and Executive 

Order 13563: Improving Regulation and 

Regulatory Review 

B. Executive Order 13771: Reducing 

Regulations and Controlling Regulatory 

Costs 

C. Paperwork Reduction Act (PRA) 

D. Regulatory Flexibility Act (RFA) 

E. Unfunded Mandates Reform Act 

(UMRA) 

F. Executive Order 13132: Federalism 

G. Executive Order 13175: Consultation 

and Coordination With Indian Tribal 

Governments 

H. Executive Order 13045: Protection of 

Children From Environmental Health 

Risks and Safety Risks 

I. Executive Order 13211: Actions 

Concerning Regulations That 

Significantly Affect Energy Supply, 

Distribution or Use 

J. National Technology Transfer and 

Advancement Act (NTTAA) 

K. Executive Order 12898: Federal Actions 

To Address Environmental Justice in 

Minority Populations and Low-Income 

Populations 

L. Congressional Review Act (CRA) 

I. General Information 

A. Does this action apply to me? 

This final rule does not regulate any 

entity outside the EPA. Rather, the 

requirements modify the EPA’s internal 

procedures regarding the transparency 

of pivotal science underlying significant 

regulatory actions 1 and influential 

scientific information. However, the 

Agency recognizes that any entity 

interested in the EPA’s regulations may 

be interested in this final rule. For 

example, this final rule may be of 

interest to entities that conduct research 

or another scientific activity that is 

likely to be relevant to the EPA’s 

regulatory activity or development of 

influential scientific information. This 

rule has no retrospective effect on either 

final significant regulatory actions or 

influential scientific information. 

B. What action is the Agency taking? 

The EPA is issuing this final rule to 

help strengthen the transparency of the 

dose-response data underlying certain 

EPA actions and to set the overarching 

structure and principles for 

transparency of pivotal science in 

significant regulatory actions and 

influential scientific information. This 

rule has a much narrower scope than 

the 2018 proposed rule (Ref. 5) and the 

2020 supplemental notice of proposed 

rulemaking (Ref. 7). The rule describes 

how the EPA will determine the 

consideration to afford pivotal science 

of the EPA’s significant regulatory 

actions and influential scientific 

information for which the conclusions 

are driven by the quantitative 

relationship between the amount of 

dose or exposure to a pollutant, 

contaminant, or substance and an effect 

based on the availability of the 

underlying dose-response data and 

other applicable factors. This rule builds 

upon prior EPA actions in response to 

Government-wide data access and 

sharing policies. 

First, the EPA is requiring that, when 

promulgating significant regulatory 

actions or developing influential 

scientific information, the Agency will 

determine which studies constitute 

pivotal science and give greater 

consideration to those studies 

determined to be pivotal science for 

which the underlying dose-response 

data are available in a manner sufficient 

for independent validation. 

Second, the EPA is establishing 

provisions for how the requirements of 

this part will apply. This rule sets the 

overarching structure and principles for 

transparency of pivotal science in 

significant regulatory actions and 

influential scientific information. The 

final rule provides that if implementing 

the rule results in any conflict between 

this rule and the environmental statutes 

that the EPA administers, and their 

implementing regulations, this rule will 

yield and the statutes and regulations 

will be controlling. 

Third, this rule requires that the EPA 

shall clearly identify all science that 

serves as the basis for informing a 

significant regulatory action. The EPA 

shall make all such science that serves 

as the basis for informing a significant 


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Federal Register / Vol. 86, No. 3 / Wednesday, January 6, 2021 / Rules and Regulations 471 

2Chrysler Corp. v. Brown, 441 U.S. 281, 309 

(1979). 3 Id. at 310. 

4Authority of EPA to Hold Employees Liable for 

Negligent Loss, Damage, or Destruction of 

Government Personal Property, 32 O.L.C. 79, 2008 

WL 4422366 at *4 (May 28, 2008) (‘‘OLC Opinion’’). 

regulatory action publicly available to 

the extent practicable using standards 

for protecting identifiable information. 

Fourth, the EPA is establishing 

requirements for the independent peer 

review of pivotal science. 

Fifth, the EPA is finalizing a provision 

that provides criteria for the 

Administrator to consider when 

granting case-by-case exemptions to the 

requirements of this rule. 

The EPA is also defining the 

following terms for the purposes of this 

rule: ‘‘data,’’ ‘‘dose-response data,’’ 

‘‘independent validation,’’ ‘‘influential 

scientific information,’’ ‘‘pivotal 

science,’’ ‘‘publicly available,’’ 

‘‘reanalyze,’’ ‘‘science that serves as the 

basis for informing a significant 

regulatory action,’’ and ‘‘significant 

regulatory actions.’’ 

Finally, the EPA intends to issue 

implementation guidelines that will 

help execute this final rule consistently 

across programs. This may include the 

process for designating key studies as 

pivotal science, documenting the 

availability of dose-response data, and 

requesting an Administrator’s 

exemption. 

C. What is the Agency’s authority for 

taking this action? 

The EPA is authorized to issue this 

rule under its authority to promulgate 

housekeeping regulations governing its 

internal affairs (hereinafter, 

‘‘housekeeping authority’’). This final 

rule describes how the EPA will 

determine the consideration to afford 

pivotal science of the EPA’s final 

significant regulatory actions and 

influential scientific information based 

on the availability of the underlying 

dose-response data and other applicable 

factors. This rule exclusively pertains to 

the internal practices of the EPA and 

does not regulate the conduct or 

determine the rights or obligations of 

any entity outside the Federal 

Government. 

The Federal Housekeeping Statute (5 

U.S.C. 301) provides that ‘‘[t]he head of 

an Executive department or military 

department may prescribe regulations 

for the government of his department, 

the conduct of its employees, the 

distribution and performance of its 

business, and the custody, use, and 

preservation of its records, papers, and 

property.’’ As the Supreme Court 

discussed in Chrysler Corp. v. Brown, 

the intended purpose of section 301 was 

to grant early Executive departments the 

authority ‘‘to govern internal 

departmental affairs.’’ 2 As the Supreme 

Court further explained, section 301 

authorizes ‘‘what the [Administrative 

Procedure Act] terms ‘rules of agency 

organization, procedure or practice’ as 

opposed to substantive rules.’’ 3

While the EPA is not one of the 

‘‘Executive departments’’ referred to in 

5 U.S.C. 101, the EPA gained 

housekeeping authority equivalent to 

that granted to Executive departments in 

section 301 through the Reorganization 

Plan No. 3 of 1970, 84 Stat. 2086 (July 

9, 1970), which created the EPA. The 

Reorganization Plan established the 

Administrator as ‘‘head of the agency,’’ 

transferred functions and authorities of 

various agencies and Executive 

departments to the EPA, and gave the 

EPA the authority to promulgate 

regulations to carry out the transferred 

functions. 

Section 2(a)(1)–(8) of the 

Reorganization Plan transferred to the 

EPA functions previously vested in 

several agencies and Executive 

departments including the Departments 

of the Interior and Agriculture. Section 

2(a)(9) also transferred so much of the 

functions of the transferor officers and 

agencies ‘‘as is incidental to or 

necessary for the performance by or 

under the Administrator of the 

functions transferred’’ and provided that 

‘‘[t]he transfers to the Administrator 

made by this section shall be deemed to 

include the transfer of [ ] authority, 

provided by law, to prescribe 

regulations relating primarily to the 

transferred functions.’’ The Federal 

Housekeeping Statute was existing law 

at the time the Reorganization Plan was 

enacted. Further, the Reorganization 

Plan does not limit the authority to 

promulgate regulations only to the 

transferred functions, but rather it 

transfers all authority that ‘‘relate[s]’’ to 

the transferred functions. Housekeeping 

authority is ancillary to the transferred 

functions because it allows the EPA to 

establish standard, internal procedures 

that are necessary to carry out and 

support those functions. Accordingly, 

the concomitant Federal housekeeping 

authority to issue procedural rules was 

transferred to the EPA. 

The Office of Legal Counsel has 

opined that the Reorganization Plan 

‘‘convey[s] to the [EPA] Administrator 

all of the housekeeping authority 

available to other department heads 

under section 301’’ and demonstrates 

that ‘‘Congress has vested the 

Administrator with the authority to run 

EPA, to exercise its functions, and to 

issue regulations incidental to the 

performance of those functions.’’ 4

Courts have recognized the EPA as an 

agency with Federal housekeeping 

authority. The U.S. Court of Appeals for 

the Second Circuit, in EPA v. General 

Elec. Co., 197 F.3d 592, 595 (2nd Cir. 

1999), found that ‘‘the Federal 

Housekeeping Statute, 5 U.S.C. 301, 

authorizes government agencies such as 

the EPA to adopt regulations regarding 

‘the custody, use, and preservation of 

[agency] records, papers, and 

property.’ ’’ The U.S. Court of Appeals 

for the Fourth Circuit, in Boron Oil Co. 

v. Downie, 873 F.2d 67, 69 (4th Cir. 

1989), held that the district court had 

exceeded its jurisdiction when it had 

compelled testimony contrary to duly 

promulgated EPA regulations, which the 

EPA argued were authorized by section 

301. The Second and Fourth Circuits 

did not directly address whether the 

EPA was an ‘‘Executive department,’’ 

but rather recognized that the EPA has 

the authority to issue regulations 

governing its internal affairs and 

assumed that authority comes from 

section 301. Indeed, if the EPA did not 

possess housekeeping authority, the 

EPA would not be able to efficiently 

carry out its daily functions, which 

would in turn compromise the EPA’s 

ability to exercise its duties as a Federal 

regulatory agency. 

On April 30, 2018, the EPA published 

the Strengthening Transparency in 

Regulatory Science Proposed 

Rulemaking (‘‘2018 proposed rule,’’ Ref. 

5). The 2018 proposed rule cites as 

authority several environmental statutes 

that the EPA administers: The Clean Air 

Act (CAA); the Clean Water Act (CWA); 

the Safe Drinking Water Act (SDWA); 

the Resource Conservation and 

Recovery Act (RCRA); the 

Comprehensive Environmental 

Response, Compensation, and Liability 

Act (CERCLA); the Federal Insecticide, 

Fungicide, and Rodenticide Act 

(FIFRA); the Emergency Planning and 

Community Right-To-Know Act 

(EPCRA); and the Toxic Substances 

Control Act (TSCA). Subsequently, on 

May 25, 2018, the EPA published a 

document extending the comment 

period and announced a public hearing 

on the 2018 proposed rule to be held on 

July 18, 2018 (Ref. 6). That document 

identified 5 U.S.C. 301 as a source of 

authority in addition to those statutes 

cited in the 2018 proposed rule. 

On March 18, 2020, in the Federal 

Register at 85 FR 15396, the EPA 


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472 Federal Register / Vol. 86, No. 3 / Wednesday, January 6, 2021 / Rules and Regulations 

5Chrysler Corp., 441 U.S. 281 at 301–02. 

6 Id. at 301 (quoting 5 U.S.C. 553(b), (d)). 

7 Id. at 302. 

published the Strengthening 

Transparency in Regulatory Science 

Supplemental Notice of Proposed 

Rulemaking (‘‘2020 SNPRM,’’ Ref. 7), in 

which the EPA clarified some of the 

citations in the 2018 proposed rule (Ref. 

5). However, because this is purely a 

procedural rule, the EPA is not relying 

on any substantive environmental 

statutes as authority. 

This action is a procedural rule 

within the scope of the EPA’s 

housekeeping authority. As the 

Supreme Court explained in Chrysler 

Corp., rules of internal agency 

management are considered procedural 

rules as opposed to substantive rules 

under the APA.5 Even if there could be 

downstream practical effects on the 

voluntary behavior of outside parties 

and on outside parties’ interactions with 

the EPA, such impacts do not render 

this procedural rule substantive. (See 

American Hosp. Ass’n v. Bowen, 834 

F.2d 1037, 1051 (D.C. Cir. 1987)— 

‘‘[A]gency rules that impose ‘derivative,’ 

‘incidental,’ or ‘mechanical’ burdens 

upon regulated individuals are 

considered procedural, rather than 

substantive.’’). As the Supreme Court 

explained in Chrysler Corp., ‘‘the central 

distinction among agency regulations 

found in the APA is that between 

‘substantive rules’ on the one hand and 

‘interpretive rules, general statements of 

policy, or rules of agency organization, 

procedure, or practice on the other.’ ’’ 6

The Supreme Court further clarified that 

unlike procedural rules, substantive 

rules have legal force and effect on 

individual rights and obligations, and 

noted that whether a rule affects 

individual rights and obligations is an 

‘‘important touchstone’’ for 

distinguishing substantive rules from 

other types of rules.7 This final rule 

does not regulate the rights and 

obligations of any party outside of the 

EPA let alone have legal force and effect 

on them. Any incidental impacts on 

voluntary behavior outside of the EPA 

do not render this a substantive rule. 

Some public commenters asserted 

that the EPA lacks the authority under 

the substantive environmental statutes 

that it administers to promulgate this 

rule. However, the EPA is relying 

exclusively on its housekeeping 

authority to promulgate this purely 

procedural rule. In this final procedural 

rule, the EPA does not interpret or apply 

provisions of a particular statute or 

statutes that it administers. The EPA 

will undertake such efforts in 

forthcoming actions, which will be 

either statute-specific science 

transparency regulations or 

programmatic regulations implementing 

this procedural rule. Some of these 

subsequent actions will be substantive 

rules issued under the associated 

environmental statutes and will be 

subject to judicial review. In this action, 

the EPA is finalizing a rule of internal 

agency procedures, including how the 

Agency will consider the availability of 

dose-response data underlying pivotal 

science used in its significant regulatory 

actions and influential scientific 

information for independent validation. 

Some public commenters nonetheless 

took the position that this rule is 

substantive because it will affect the 

Agency’s interactions with regulated 

parties. First, and as discussed above, 

this final rule does not regulate any 

party outside of the EPA but rather 

exclusively governs the EPA’s internal 

process for determining the 

consideration to afford pivotal science 

with respect to certain actions. This rule 

does not require any researcher or other 

outside entity to provide data or models 

to the EPA. Nor does the rule 

categorically exclude studies—even 

studies where the underlying doseresponse data are not available for 

independent validation—and therefore 

any incidental impact on researchers 

who are developing science and 

deciding whether to make the 

underlying dose-response data available 

is negligible. Instead, it governs internal 

agency procedures for determining the 

consideration to afford various studies 

according to factors that include data 

availability. In doing so, the final rule 

provides greater transparency on the 

consideration the EPA will give pivotal 

science where the underlying doseresponse data are or are not available for 

independent validation. 

Certain commenters stated that the 

final rule is substantive because they 

asserted it imposes burdens on 

scientists who endeavor to have their 

research considered by the EPA when it 

makes regulatory decisions or develops 

influential scientific information. The 

EPA notes, however, that procedural 

rules do not alter the rights or interests 

of parties but they ‘‘may alter the 

manner in which the parties present 

themselves or their viewpoints to the 

agency,’’ without thereby becoming 

substantive rules (James A. Hurson 

Assocs. v. Glickman, 229 F.3d 277, 280 

(D.C. Cir. 2000)). If researchers want to 

increase the likelihood that their studies 

receive greater consideration by the 

EPA, they may take steps to ensure that 

the underlying dose-response data are 

available to the greatest extent possible. 

But any such response to this final rule 

would be purely voluntary. It is not 

required by this rule. 

Some commenters also argued that 

this rule is not procedural because they 

asserted it conflicts with the substantive 

environmental statutes administered by 

the EPA. However, this final rule does 

not interpret or apply the provisions of 

any environmental statutes; such efforts 

will occur in the subsequent actions 

under the relevant statutes described 

above. As this rule makes clear, if 

implementing this procedural rule 

would result in conflicts with existing 

environmental statutes, and their 

implementing regulations, this rule will 

yield to the EPA statutes and 

regulations. 

This is a rulemaking of agency 

organization, procedure, or practice. 

This procedural rule would not regulate 

any person or entity outside the EPA 

and would not affect the rights or 

obligations of outside parties. As a rule 

of Agency procedure, this rule is exempt 

from the notice-and-comment and 

delayed effective-date requirements set 

forth in the Administrative Procedure 

Act. See 5 U.S.C. 553(a)(2), (b)(A), (d). 

Nonetheless, the Agency voluntarily 

sought public comment on the proposed 

rule because it believed that the 

information and opinions supplied by 

the public would inform the Agency’s 

views. Vt. Yankee Nuclear Power Corp. 

v. Nat. Res. Def. Council, Inc., 435 U.S. 

519, 524 (1978) (‘‘Agencies are free to 

grant additional procedural rights in the 

exercise of their discretion.’’) In 

addition, even assuming arguendo that 

the delayed effective-date requirement 

of the Act applied to this action, the 

EPA has determined that there would be 

good cause, consistent with 5 U.S.C. 

553(d)(3), for making this final rule 

effective immediately because 

immediate implementation of the rule, 

with its goals of ensuring transparency 

and consistency in how the agency 

considers dose-response data 

underlying pivotal science to be used in 

significant regulatory decisions and 

influential scientific information, is 

crucial for ensuring confidence in EPA 

decision-making. Because this is a 

procedural rule that only applies 

internally to ensure that the EPA 

consistently considers data availability, 

the rationale for delayed effectiveness to 

allow reasonable time for non-EPA 

regulated entities to adjust their 

behavior before and prepare for the 

effective date of the new requirements 

does not apply. See Omnipoint Corp. v. 

Fed. Commc’n Comm’n, 78 F.3d 620, 

630 (D.C. Cir. 1996); see also United 

States v. Gavrilovic, 551 F.2d 1099, 

1104 (8th Cir. 1977) (quoting legislative 

history). For these reasons, the Agency 


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Federal Register / Vol. 86, No. 3 / Wednesday, January 6, 2021 / Rules and Regulations 473 

finds that good cause exists under APA 

section 553(d)(3) to make this rule 

effective immediately upon publication. 

II. Background 

A. Summary of 2018 Proposed Rule 

In the 2018 proposed rule (Ref. 5), the 

EPA proposed adding 40 CFR part 30, 

which would direct the EPA to ensure 

that the pivotal regulatory science 

underlying its actions is publicly 

available in a manner sufficient for 

independent validation. The EPA 

proposed to take this action under the 

authority of the statutes it administers, 

including provisions providing general 

authority to promulgate regulations 

necessary to carry out the Agency’s 

functions under these statutes and 

provisions specifically addressing the 

Agency’s conduct of and reliance on 

scientific activity to inform those 

functions. 

In the 2018 proposed rule, the EPA 

defined ‘‘dose-response data and 

models,’’ ‘‘pivotal regulatory science,’’ 

‘‘regulatory decisions,’’ ‘‘regulatory 

science,’’ and ‘‘research data’’ (proposed 

40 CFR 30.2). 

Many of the provisions in proposed 

40 CFR part 30 applied to dose-response 

models and data, regardless of the 

source of funding or identity of the 

party who developed the model or 

generated the data. Specifically, the EPA 

proposed that the Agency would ensure 

that dose-response data and models 

underlying pivotal regulatory science 

were publicly available in a manner 

sufficient for independent validation, 

including releasing information 

necessary for the public to ‘‘understand, 

assess, and replicate findings’’ 

(proposed 40 CFR 30.5). The public 

release of such information would be 

consistent with law; protect privacy, 

confidentiality, and confidential 

business information (CBI); and be 

sensitive to national security interests. 

In addition to proposing requirements 

for ensuring that dose-response data and 

models were publicly available in a 

manner sufficient for independent 

validation, the EPA proposed additional 

requirements pertaining to the use of 

dose-response data and models 

underlying pivotal regulatory science. 

Proposed 40 CFR 30.6 would have 

required the EPA to: Describe and 

document any assumptions and 

methods used; clearly explain the 

scientific basis for each model 

assumption used and present analyses 

showing the sensitivity of the modeled 

results to alternative assumptions; 

evaluate the appropriateness of using 

default assumptions (e.g., assumptions 

of a linear, no-threshold dose-response) 

on a case-by-case basis; and when 

available, give explicit consideration to 

high-quality studies that explore: A 

broad class of parametric dose-response 

or concentration-response models, a 

robust set of potential confounding 

variables, nonparametric models that 

incorporate fewer assumptions, the use 

of various threshold models across the 

dose or exposure range, and models that 

investigate factors that might account 

for spatial heterogeneity. 

The 2018 proposed rule also included 

requirements that pertained more 

broadly to the use of studies in Agency 

actions and pivotal regulatory science. 

Proposed 40 CFR 30.4 would have 

required the EPA to clearly identify all 

studies relied upon when taking any 

final Agency action and make all such 

studies available to the public to the 

extent practicable. Proposed 40 CFR 

30.7 would have required the EPA to 

conduct independent peer review of all 

pivotal regulatory science used to justify 

regulatory decisions. As part of the peer 

review, the EPA would have been 

required to ask peer reviewers to 

articulate the strengths and weaknesses 

of the Agency’s justification for the 

assumptions applied and the 

implications of those assumptions for 

the results. 

Finally, the 2018 proposed rule would 

have allowed for the EPA Administrator 

to grant exemptions to the requirements 

of the rule when the Administrator 

determined that compliance would be 

impracticable because it was not 

feasible to either (1) ensure that all doseresponse data and models underlying 

pivotal regulatory science were publicly 

available in a manner sufficient for 

independent validation, in a fashion 

consistent with law; protective of 

privacy, confidentiality, and CBI; and 

sensitive to national security interests; 

or (2) conduct independent peer review 

on all pivotal regulatory science used to 

justify regulatory decisions for reasons 

outlined in Section IX of the OMB 

Bulletin for Peer Review (Ref. 8). 

The EPA solicited comment on the 

2018 proposed rule generally and on 

specific provisions in the proposal, 

including the legal authority for the 

proposed rule, the scope of the 

proposal, public access to dose-response 

data and models, and how the proposed 

rule should be implemented. 

B. Summary of 2020 Supplemental 

Notice of Proposed Rulemaking 

The 2020 SNPRM (Ref. 7) included 

clarifications, modifications, and 

additions to certain provisions in the 

2018 proposed rule. The 2020 SNPRM 

also revised the authority cited in 

proposed 40 CFR part 30; revised 

proposed 40 CFR 30.2, 30.3, 30.5, 30.6, 

30.7, and 30.9; and deleted proposed 40 

CFR 30.10. 

Through the 2020 SNPRM, the EPA 

modified proposed 40 CFR part 30 to 

expand the scope of the 2018 proposed 

rule, clarified the intent of the 2018 

proposed rule, and solicited public 

comment on two proposed approaches 

for how the Agency would consider data 

and model availability when evaluating 

studies. The 2020 SNPRM modified the 

scope of the 2018 proposed rule in two 

ways: (1) Expanded ‘‘dose-response data 

and models’’ to ‘‘data and models,’’ and 

(2) expanded the applicability of the 

proposed requirements to influential 

scientific information, which was 

defined in the 2020 SNPRM as the 

‘‘scientific information the Agency 

reasonably can determine will have or 

does have a clear and substantial impact 

on important public policies or private 

sector decisions,’’ consistent with the 

definition of ‘‘influential scientific 

information’’ provided in the OMB 

Final Information Quality Bulletin for 

Peer Review (Ref. 8). As a result of the 

2020 SNPRM, the provisions in 

proposed 40 CFR part 30 would have 

applied to data and models, regardless 

of the source of funding or identity of 

the party who developed the model or 

generated the data, underlying pivotal 

science or pivotal regulatory science. 

The EPA modified proposed 40 CFR 

30.2, 30.3, 30.6, and 30.9 to reflect this 

change in scope of the proposed 

rulemaking. 

With the expanded scope, the EPA 

proposed that data and models 

underlying pivotal regulatory science 

and pivotal science be available in a 

manner sufficient for independent 

validation. To clarify its intent, in the 

2020 SNPRM the EPA modified and 

added proposed definitions for key 

terminology, including ‘‘data,’’ 

‘‘model,’’ ‘‘publicly available,’’ and 

‘‘independent validation.’’ Specifically, 

the EPA clarified that ‘‘independent 

validation’’ of data and models, as 

proposed, meant the ‘‘reanalysis of 

study data by subject matter experts 

who have not contributed to the 

development of the study to 

demonstrate that the same analytic 

results reported in the study are capable 

of being substantially reproduced’’ 

(2020 SNPRM proposed 40 CFR 30.2). In 

the 2020 SNPRM, the EPA also 

proposed definitions for ‘‘reanalyze’’ 

and ‘‘capable of being substantially 

reproduced’’ to further clarify the intent 

of the rulemaking. 

In proposed 40 CFR 30.5, the EPA 

solicited public comment on two 

approaches for how the Agency would 

consider data and model availability 


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when evaluating studies underlying 

pivotal regulatory science and pivotal 

science. Under the first approach, the 

Agency would have only used pivotal 

regulatory science or pivotal science 

where the underlying data and models 

were either publicly available for 

independent validation or, in the case of 

restricted data and models (e.g., those 

that include CBI, proprietary data, or 

personally identifiable information (PII) 

that cannot be sufficiently de-identified 

to protect the data subjects), available 

through restricted access in a manner 

sufficient for independent validation. 

Under the second approach, the EPA 

would have, other things equal, given 

greater consideration to studies where 

the underlying data and models were 

either publicly available in a manner 

sufficient for independent validation or, 

in the case of restricted data and 

models, available through restricted 

access in a manner sufficient for 

independent validation. Proposed 40 

CFR 30.9 would have allowed the EPA 

Administrator to grant an exemption to 

the requirements in proposed 40 CFR 

part 30 if the Administrator determined 

that compliance was impracticable 

because technological barriers rendered 

sharing of the data or models infeasible; 

the development of the data or model 

was completed or updated before the 

effective date of this final rule; or by 

making the data and models publicly 

available, it would have conflicted with 

laws governing privacy, confidentiality, 

CBI, or national security interests. 

Finally, the EPA clarified in the 2020 

SNPRM that it is authorized to 

promulgate this rulemaking under its 

housekeeping authority and revised the 

authority cited in proposed 40 CFR part 

30 accordingly. The Agency solicited 

public comment on whether to use its 

housekeeping authority independently 

or in conjunction with the 

environmental statutory provisions 

cited as authority in the 2018 proposed 

rule, which were further clarified in the 

2020 SNPRM. 

III. Description of Final Rule and 

Responses to Significant Comments 

A. Purpose and Effect of the Action 

1. Purpose. The EPA is committed to 

its mission of protecting human health 

and the environment through sound 

policy decisions that are informed by 

robust scientific and technical research. 

Because of the potential impact of the 

EPA’s significant regulatory actions and 

influential scientific information on 

American lives and livelihoods, the 

American people deserve environmental 

decisions and policies that are based on 

the best scientific information. Only 

through continuous improvement to its 

procedures, especially those focused on 

transparency, can the EPA fully 

demonstrate that commitment. 

The purpose of this action is to 

increase transparency by codifying 

internal procedural requirements for 

how the EPA will consider the 

availability of the underlying doseresponse data that it relies upon to 

promulgate significant regulatory 

actions and develop influential 

scientific information. These 

requirements build upon open data 

initiatives in the Federal Government 

and scientific community and advance 

the EPA’s mission and commitment to 

the public by prioritizing transparency 

of the underlying dose-response data in 

pivotal science for the most impactful of 

EPA’s assessments and regulatory 

actions. Where underlying doseresponse data in pivotal science are 

available, subject matter experts could 

independently reanalyze the data to 

affirm original research conclusions, 

check for errors, test alternative 

assumptions, and better understand and 

evaluate the implications of the 

uncertainty used in the original 

analysis. Such independent reanalyses 

will subsequently enable the EPA to 

make stronger, data-driven decisions in 

future rulemakings or in revisions to 

existing rules or influential scientific 

information. This could occur through 

standard cyclical reviews (e.g., revisions 

to national ambient air quality 

standards, risk and technology reviews, 

national primary drinking water 

regulations), ad hoc revisions, or 

revisions through the information 

quality guidelines or other petition 

processes. Implementation of this rule 

will more effectively share pivotal 

science for external consideration and 

increase the opportunity for 

independent validation of pivotal 

science by subject matter experts. As 

data are better understood through 

independent reanalysis, the public will, 

if they so choose, be able to more 

effectively comment, engage, and hold 

the EPA accountable during the 

development of future significant 

regulatory actions and influential 

scientific information. 

The transparency provisions in this 

final rule are intended to build upon 

existing Federal Government efforts and 

provide incremental progress toward the 

Agency’s goal of greater transparency. 

The EPA and the Federal Government 

have long encouraged open data 

initiatives, as the principle of 

transparency in regulatory decisionmaking and the other operations of 

government agencies is a fundamental 

behavior of good government that is 

inherently valuable to the public. For 

example, in 2002 the Office of 

Management and Budget (OMB) 

released its Guidelines for Ensuring and 

Maximizing the Quality, Objectivity, 

Utility, and Integrity of Information 

Disseminated by Federal Agencies, 

which includes discussion of the 

importance of the reproducibility of 

analyses underlying influential 

information (Ref. 3). The EPA’s 2016 

Plan to Increase Access to Results of 

EPA-Funded Scientific Research noted 

that ‘‘transparency is a core EPA value’’ 

and that increased availability of 

research data would accelerate scientific 

breakthroughs that support the Agency’s 

mission and policymaking efforts (Ref. 

9). The EPA’s Open Government Plan 

5.0 (Ref. 10) also details the EPA’s 

progress in implementing the tenets of 

the numerous data transparency 

initiatives in the Federal Government 

prior to 2018, including the Office of 

Management and Budget (OMB) M–10– 

06 (Ref. 11), the Office of Science and 

Technology Policy Memorandum of 

February 22, 2013 (Ref. 12), and OMB 

M–13–13 (Ref. 4). In 2019, Congress 

passed the Foundations for EvidenceBased Policymaking Act of 2018 (or 

OPEN Government Data Act, Public Law 

115–435) into law, which included 

requirements for Federal agencies to 

prioritize making their data available to 

the public, and OMB has released 

additional guidance for implementing 

the act (Refs. 13, 14). 

The scientific community has also 

embraced greater data transparency, as 

evidenced by data sharing and 

availability requirements for many highimpact journals (Ref. 15) and the 

emergence of organizations, such as the 

Center for Open Science, and 

international initiatives like Findable, 

Accessible, Interoperable, and Reusable 

(FAIR) data principles; Facilitate Open 

Science Training in European Research 

(FOSTER); and Guidelines for 

Transparency and Openness Promotion 

(TOP) in Journal Policies and Practices 

that incentivize greater transparency in 

research (Refs. 16, 17). 

The EPA supports these efforts and is 

pursuing an incremental approach to 

maximizing transparency in the science 

that it relies upon to ensure that 

implementation is done in a thoughtful 

and deliberate way that focuses on the 

EPA’s most impactful actions, 

minimizes unintended consequences, 

and informs future transparency 

requirements. As further described in 

Section II.B of this preamble, the EPA is 

focusing on the underlying doseresponse data for this rulemaking 

because of the influence these data have 

on particularly impactful decisions at 


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8The NAS workshop on Reproducibility and 

Replicability in Science defines ‘‘reproducibility’’ 

to mean the extent to which a researcher can obtain 

consistent computational results using the same 

input data, computational steps, methods, code, 

and conditions of analysis. The use of 

‘‘reproducibility’’ by the NAS is consistent with the 

intent of the use of ‘‘independent validation’’ in this 

rule. 

the Agency. Risk assessments and 

regulations that target emissions and 

risk reduction of one or more pollutants, 

contaminants, or substances are integral 

to the Agency’s mission and the 

underlying dose-response data that 

inform the quantitative value used to 

evaluate and mitigate potential risk are 

critical to understanding the assessment 

or regulatory action. In addition, the 

data underlying the dose-response 

assessment are more distinct than the 

broad range of data informing an entire 

risk assessment. Therefore, the EPA is 

concentrating its current efforts to 

increase transparency on a well-defined 

step in the quantitative assessment of 

risk supporting specific Agency actions. 

This final rule provides an important 

step in furthering the progress already 

being made toward maximizing 

transparency and will provide 

important insight for developing future 

statute-specific requirements. 

Most public commenters on the 

purpose of the 2018 proposed rule and 

the 2020 SNPRM supported the concept 

of greater transparency, but questioned 

the ‘‘problem’’ the EPA was trying to fix. 

Other commenters indicated that it was 

not clear how greater data availability 

would fix these perceived problems, 

given what they asserted were limited 

detail in the proposed rule. Some public 

commenters and members of the EPA’s 

Science Advisory Board (SAB) also 

suggested that issues related to 

transparency are or may be fixed with 

existing guidance, mechanisms, and 

other requirements. Other commenters 

questioned the motivation for the 

rulemaking, asserting that the 

rulemaking was the result of political 

interests, rather than scientific need; 

that it was biased to benefit industry; or 

that it was a deliberate attempt to 

suppress human health and climate 

studies. Some commenters contended 

that there was little evidence of a 

widespread reanalysis issue in science 

or, in particular, studies that would 

inform environmental policy. Other 

commenters contended that the 

rulemaking was at odds with the 

Agency’s mission and would result in 

decreased environmental and human 

health protections. Some commenters 

asserted that the rule would lead to 

increased litigation and limit the 

public’s trust in the EPA. Other 

commenters contended that the rule was 

inconsistent with practices in other 

Federal agencies and may adversely 

impact other Federal and state agencies 

that rely on EPA assessments. 

Commenters supporting the 

rulemaking generally asserted that the 

greater transparency provided in the 

proposal and SNPRM was necessary and 

important for developing sound and 

scientifically robust regulations. Some 

commenters stated that transparency is 

a principle of good government. Some 

commenters noted specific benefits to 

greater transparency, including more 

effective public scrutiny and scientific 

debate, less political rhetoric, and 

clearer, more efficient regulations. Some 

commenters provided specific examples 

of EPA regulations or risk assessments 

that have relied on incorrect data or 

would have been improved with greater 

transparency. Other commenters 

contended that greater transparency was 

consistent or complementary with 

research and publishing policies, 

Federal Government policies, and the 

scientific method, while other 

commenters asserted that the rule 

would be an important improvement to 

transparency at the EPA. 

The EPA continues to believe that 

codifying internal procedures aimed at 

prioritizing transparency in significant 

regulatory actions and influential 

scientific information into regulation 

will improve the opportunity for the 

public to access the EPA’s scientific 

analyses and resulting regulatory 

actions in a way that is beneficial to the 

scientific process, the Agency’s mission, 

and the public’s health and safety. This 

rule is designed to build upon OMB M– 

19–15 (Ref. 18), which highlights the 

need to characterize the sensitivity of an 

agency’s conclusions to analytic 

assumptions, as well as other Federal 

guidance documents that require greater 

data transparency (Ref. 18). The EPA’s 

attention to data transparency is also 

responsive to the broader interest in 

greater data and model transparency 

observed in the numerous transparency 

initiatives in the scientific community 

and Federal Government, as well as the 

criticism the EPA has received from 

members of the public, scientific 

community, and Congress on the 

transparency of the scientific basis for 

EPA’s decisions in previous influential 

scientific information assessments and 

regulatory actions (Refs. 19, 20, 21, 22, 

23). The EPA’s continued progress 

toward maximizing transparency is vital 

to building and maintaining trust with 

the public and credibility in the 

Agency’s decisions. 

The EPA disagrees with the 

contention that this rule is politically 

motivated, as transparency assumes no 

political ideology, nor is this rule likely 

to result in decreased human health or 

environmental protections, as the 

benefits of greater data transparency and 

the significance of reanalyzing and 

validating study results are welldocumented in scientific literature. 

McNutt (2014) noted, ‘‘reproducibility, 

rigor, transparency, and independent 

verification are cornerstones of the 

scientific method’’ (Ref. 24). The 

National Academies of Sciences, 

Engineering, and Medicine (NAS) 

workshop on Reproducibility and 

Replicability in Science also noted that 

‘‘certainly, reproducibility and 

replicability play an important role in 

achieving rigor and transparency’’ (Ref. 

16).8 Munafo` et al. (2017) state, ‘‘the 

credibility of scientific claims is rooted 

in the evidence supporting them, which 

includes the methodology applied, the 

data acquired, and the process of 

methodology implementation, data 

analysis and outcome interpretation. 

Claims become credible by the 

community reviewing, critiquing, 

extending and reproducing the 

supporting evidence. However, without 

transparency, claims only achieve 

credibility based on trust in the 

confidence or authority of the 

originator. Transparency is superior to 

trust’’ (Ref. 25). The 2019 NAS 

workshop on Reproducibility and 

Replicability in Science also concluded, 

‘‘the scientific enterprise depends on 

the ability of the scientific community 

to scrutinize scientific claims and to 

gain confidence over time in results and 

inferences that have stood up to 

repeated testing’’ (Ref. 16). Importantly, 

the workshop also concluded that 

researchers, funding institutions, and 

journals could make advancements to 

improve reproducibility, rigor, and 

transparency (Ref. 16). 

The EPA agrees that data transparency 

is vital for individuals who have not 

contributed to the study to be able to 

verify the quality and strength of 

published studies and agrees with 

commenters that the opportunity to 

independently validate the pivotal 

science that the EPA relies upon is 

important in furthering scientific 

understanding and the Agency’s 

mission. A presenter in a 2016 NAS 

workshop on Principles and Obstacles 

for Sharing Data from Environmental 

Health Research stated more directly 

that ‘‘for environmental policy making 

to be legitimate, the scientific reasoning 

behind a given decision—including the 

data supporting it—must be 

transparent’’ (NAS Workshop Report, 

Ref. 26). When data are widely 

available, researchers can validate 


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9The SAB also provided several constructive 

comments and recommendations, which have been 

considered in the development of this final rule. 

research results and help identify and 

correct unintended errors, as well as 

reanalyze the data for new and different 

purposes, examine novel questions, 

provide new scientific insights, and 

improve model development. In its 

April 24, 2020, letter to EPA 

Administrator Wheeler (Ref. 27), the 

EPA’s SAB noted that it 

‘‘recognizes the importance of this rule and 

its purpose, establishing transparency of the 

influential scientific information used for 

significant regulations and enhancing public 

access to scientific data and analytical 

methods to help ensure scientific integrity, 

consistency and robust analysis. 

Strengthening transparency by improving 

access to data can lead to an increase in the 

quantity and the quality of evidence that 

informs important regulatory and policy 

decisions. The scientific community is 

moving toward adopting the precept of 

sharing accurate data and information to 

increase credibility, high-quality outcomes 

and public confidence in science. The SAB 

supports the adoption of this precept.’’ 9

The EPA also agrees with commenters 

that the scientific community and 

government agencies are making great 

strides in data transparency; however, 

improvements can still be made over 

existing policies and mechanisms. Many 

scientific publications, for example, 

require authors to make a data 

availability or data access statement, 

which discloses where and under what 

conditions the underlying study data are 

available. Yet the EPA cannot solely rely 

on data availability statements made in 

published research because initiatives 

toward greater data sharing and 

transparency amongst scientific journals 

and international organizations are still 

being implemented, are inconsistently 

enforced, and the true accessibility of 

data in a public repository is still 

limited (Refs. 28, 29, 30, 31, 32, 33). For 

example, Christensen et al. (2019) 

evaluated 1,072 peer-reviewed articles 

and ‘‘found that rates of data availability 

for empirical articles published after 

journals adopted data-sharing policies 

differ widely between journals, from 0 

percent to 83 percent, with a mean of 35 

percent’’ (Ref. 32). Stodden et al. (2018) 

noted they were only able to retrieve the 

dataset and code for 44 percent of the 

204 computational studies published in 

Science in the 16 months after the 

publisher instituted its data availability 

requirements (Ref. 34). Therefore, the 

rule requirements for the EPA’s 

independent evaluation of the 

availability of data are necessary and 

critical to prioritizing data transparency 

in the pivotal science underlying its 

significant regulatory actions and 

influential scientific information. 

Finally, focusing the final rule 

requirements on the underlying doseresponse data is intended to address 

public comments concerning clarity of 

the rule, potential unintended 

consequences, and the potential for farreaching impacts. The requirements 

provide a workable framework for 

evaluating pivotal science in the context 

of the availability of its underlying doseresponse data, while balancing 

important technical considerations in 

order to ensure the Agency maintains a 

strong scientific basis for its decisionmaking. The incremental progress made 

possible by this rule provides an 

important step towards prioritizing 

transparency in particularly impactful 

EPA rules and assessments and will 

inform future statute-specific 

rulemakings. 

2. Effect of this rule on the studies the 

EPA uses to support significant 

regulatory actions and influential 

scientific information. The EPA received 

significant comment on the effect of the 

2018 proposed rule and 2020 SNPRM 

on the studies the Agency would be able 

to consider and use to support 

significant regulatory actions and 

influential scientific information. Many 

commenters asserted that the EPA’s 

action, if finalized, would limit the 

scientific studies the EPA could use 

because the EPA would exclude from 

consideration any studies where the 

underlying data and models could not 

be made publicly available or available 

in a manner sufficient for independent 

validation. 

As discussed in Section III.B of this 

preamble, based on a consideration of 

the public comments on the 2018 

proposed rule and the 2020 SNPRM, the 

EPA is finalizing internal procedural 

requirements for how the Agency will 

consider the availability of underlying 

dose-response data of pivotal science 

when promulgating a significant 

regulatory action or developing 

influential scientific information that 

relies on dose-response data. The EPA is 

also further clarifying how the Agency 

will determine the consideration to 

afford to pivotal science in either 

significant regulatory actions or 

influential scientific information. 

Consistent with existing Agency 

practice (Ref. 35), the EPA will review 

and evaluate all relevant scientific 

studies when developing significant 

regulatory actions and influential 

scientific information. The EPA will 

continue to use the following, 

established factors to assess the quality 

of studies used to develop significant 

regulatory actions and influential 

scientific information (Refs. 36, 37): 

• Soundness—The extent to which 

the scientific and technical procedures, 

measures, methods or models employed 

to generate the information are 

reasonable for, and consistent with, the 

intended application. 

• Applicability and Utility—The 

extent to which the information is 

relevant for the Agency’s intended use. 

• Clarity and Completeness—The 

degree of clarity and completeness with 

which the data, assumptions, methods, 

quality assurance, sponsoring 

organizations and analyses employed to 

generate the information are 

documented. 

• Uncertainty and Variability—The 

extent to which the variability and 

uncertainty (quantitative and 

qualitative) in the information or in the 

procedures, measures, methods or 

models are evaluated and characterized. 

• Evaluation and Review—The extent 

of independent verification, validation 

and peer review of the information or of 

the procedures, measures, methods or 

models. 

When evaluating potential links 

between exposure to a pollutant, 

contaminant, or substance and effects 

and the nature of the dose-response 

relationship, the EPA will follow best 

practices and rely on the highest 

quality, most relevant studies in 

determining the potential for hazard due 

to exposure to a pollutant, contaminant, 

or substance. Where there is convincing 

and well-substantiated evidence 

(consistent with Agency guidelines on 

hazard identification and dose-response 

assessment) to support a relationship 

between exposure and effect, the EPA 

will identify a subset of those studies for 

use in characterizing the quantitative 

relationship between the amount of 

dose or exposure to a pollutant, 

contaminant, or substance and an effect. 

This will be based on the exposure 

situation being addressed, the quality of 

the studies, the reporting adequacy, and 

the relevance of the endpoints. From 

that subset, the specific dose-response 

studies or analyses that drive the 

requirements, quantitative analyses, or 

both will be identified as pivotal science 

(see Section III.E of this preamble). 

Once the EPA has identified pivotal 

science—for either significant regulatory 

actions or influential scientific 

information—the EPA will then 

evaluate if the underlying dose-response 

data are available in a manner sufficient 

for independent validation. The EPA 

will give greater consideration to pivotal 

science for which the underlying doseresponse data are either publicly 

available in a manner sufficient for 


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independent validation or, in the case of 

PII, CBI, or proprietary data, available 

through restricted access that affords 

privacy in a manner sufficient for 

independent validation. 

The EPA acknowledges, and agrees 

with commenters, that there may be 

pivotal science for which the underlying 

dose-response data are not publicly 

available due to technological feasibility 

or cannot be made available in a secure 

environment that still allows for 

independent analysis. For example, 

dose-response data underlying older 

pivotal science may no longer be 

available or may not exist in a currently 

usable format. In these cases, the EPA 

may still use the pivotal science after 

either giving it lesser consideration or 

receiving an exemption from the 

requirements of this rule from the 

Administrator (see Section III.G of this 

preamble). See Section III.E of this 

preamble for a description of the factors 

the EPA will consider when 

determining the consideration to afford 

to pivotal science when the underlying 

dose-response data are not available for 

independent validation. 

The EPA expects to identify pivotal 

science, and the consideration afforded 

to pivotal science, in proposed 

significant regulatory actions and 

external review drafts of influential 

scientific information, which will allow 

the subject matter experts, if they so 

choose, to independently validate the 

pivotal science and provide comment to 

the EPA. The EPA believes that this 

approach will allow the public to more 

effectively comment, engage, and hold 

the EPA accountable during the future 

development of specific significant 

regulatory actions and influential 

scientific information. 

3. Effect of this rule on human health 

and environmental protection. Many 

commenters contended that the 2018 

proposed rule and the 2020 SNPRM 

would prevent the EPA from meeting its 

statutory obligations and performing its 

mission of protecting human health and 

the environment. Some commenters 

asserted that, by excluding studies 

based on data availability, the EPA 

would develop regulatory decisions that 

are: (1) Not based on high-quality 

studies or the best available science; and 

(2) potentially biased towards regulated 

parties. As a result, these commenters 

argued that human health and 

environmental protections would 

decrease. Several commenters 

contended that decreased human health 

and environmental protections would 

disproportionately affect communities 

of color, indigenous communities, and 

low-income communities because these 

communities are more likely to live or 

work near sources of pollution. 

The EPA considered these comments 

when finalizing this rule, and the EPA 

does not agree that its approach will 

lead to systematic bias towards certain 

types of stakeholder goals. As described 

above, the EPA is not categorically 

excluding any studies from 

consideration when promulgating 

significant regulatory actions or 

developing influential scientific 

information. Rather, the Agency will 

continue to evaluate the quality of all 

relevant studies, consistent with the 

intended use of the information. The 

EPA will also continue to rely on the 

highest quality, most relevant studies 

available in determining the potential 

for hazard due to exposure to a 

pollutant, contaminant, or substance. 

When characterizing the quantitative 

relationship between the amount of 

dose or exposure to a pollutant, 

contaminant, or substance and an effect, 

the EPA will identify pivotal science 

and give greater consideration to pivotal 

science for which the underlying doseresponse data are available in a manner 

sufficient for independent validation. 

Including this review of dose-response 

data availability for pivotal science is 

critical to the EPA’s progress toward 

increased transparency and providing 

increased opportunity for scientific 

reanalysis and review by independent 

third parties. This approach will result 

in significant regulatory actions and 

influential scientific information that 

are based on high quality studies that 

maximize transparency, leading to 

human health and environmental 

protections consistent with the statutes 

the EPA administers. 

In response to the 2018 proposed rule, 

the EPA received comments on 

perceived conflicts between the 

requirements included in the 2018 

proposed rule and statutory 

requirements that direct EPA to 

consider certain data and information 

when developing Agency actions. For 

example, some commenters contended 

that the requirements in the 2018 

proposed rule conflicted with the FIFRA 

pesticide registration requirements and 

associated implementing regulations, 

which require registrants to submit data 

and information to the EPA to enable 

the Agency to make its unreasonable 

adverse effects determinations. These 

commenters argued that, under the 2018 

proposed rule, the EPA would not be 

able to consider these data, which are 

often claimed as CBI, when evaluating 

the pesticide registrations because the 

data could not be made publicly 

available. In response to this comment 

and other similar comments, the EPA 

clarified in the 2020 SNPRM the 

relationship between this rulemaking, 

the environmental statutes and their 

implementing regulations by adding 

language to proposed 40 CFR 30.3 

stating that statutory requirements and 

corresponding implementing 

regulations would control in the event 

of any conflicts. 

With this final rule, the EPA is 

maintaining language from the 2020 

SNPRM in 40 CFR 30.3 stating that 

statutory requirements and 

corresponding implementing 

regulations will control in the event of 

any conflict, and clarifying in this 

preamble that the requirements in this 

final rule set the overarching structure 

and principles for transparency in 

significant regulatory actions and 

influential scientific information. The 

EPA plans to promulgate either statutespecific transparency regulations or 

programmatic actions implementing this 

procedural rule, as appropriate, to 

clarify how the Agency will implement 

the provisions from this final rule for 

specific programs authorized under the 

statutes the EPA administers. 

B. Dose-Response Data 

The 2018 proposed rule focused on 

dose-response data and models, 

although not consistently. For example, 

some parts of the proposed regulatory 

text appear to limit applicability of 

certain provisions to only dose-response 

models. In others, the proposed 

requirements would apply more 

broadly. Commenters noted this 

variability. As a result, in the 2020 

SNPRM, the EPA proposed a consistent, 

broader applicability to data and 

models. 

The EPA received significant 

comment on this proposed expansion of 

the applicability of the rulemaking to 

data and models. While some 

commenters supported this expansion, 

other commenters contended that the 

applicability to dose-response data and 

models was already very broad, and that 

the broader applicability would 

significantly limit the information that 

the EPA could consider in a broad 

ranges of assessments (e.g., 

bioaccumulation data, data on 

environmental releases, exposure 

estimates used by the EPA across the 

environmental statutes that it 

administers). Some commenters 

contended that the EPA did not provide 

sufficient rationale to support this 

expansion. 

Based on the comments on the 2018 

proposed rule and the 2020 SNPRM, 

taking into account the number of 

studies that would be subject to the rule, 

the EPA determined that the Agency 


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should pursue an incremental approach 

to maximizing transparency in the 

science that it relies upon by focusing 

the final rule requirements on doseresponse data and, in particular, only 

those studies that are integral to 

characterizing dose-response 

relationships (e.g., identifying candidate 

PODs). The EPA considered 

commenters’ assertions that the scope of 

the 2018 proposed rule would be so 

broad as to make implementation 

infeasible. The 2018 proposed definition 

of ‘‘dose-response data and models’’ 

would apply to dose-response data [and 

models] ‘‘used to characterize the 

quantitative relationship between the 

amount of dose or exposure to a 

pollutant, contaminant, or substance 

and the magnitude of a predicted health 

or environmental impact.’’ This 

relationship of the dose-response data to 

the magnitude of a predicted health or 

environmental impact would require the 

consideration of an array of studies 

beyond those that characterize doseresponse relationships, including, for 

example, studies that inform the doseresponse modeling (e.g., benchmark 

response selection); studies that identify 

data for toxicokinetic adjustments that 

inform calculation of a humanequivalent point of departure (POD); 

and studies that inform the selection of 

uncertainty factors. The number of 

studies that are used to establish the 

relationship between dose-response data 

and models and the magnitude of a 

predicted health or environmental 

impact can potentially be very large. 

This may make implementing the rule, 

as proposed, more challenging for at 

least some significant regulatory actions 

and influential scientific information. 

While transparency in EPA decisionmaking is the purpose of this action, the 

EPA prefers an incremental approach. 

Rather than having this final rule apply 

to all the studies that support the 

assessment of the relationship of a dose 

or exposure of a pollutant, contaminant, 

or substance to the magnitude of a 

predicted health or environmental 

impact, the EPA is balancing 

transparency and feasibility by focusing 

on those studies that describe the 

quantitative relationship between the 

dose or exposure of a pollutant, 

contaminant, or substance and an effect. 

Specifically, the scope of dose-response 

data in this final rule is those studies 

consisting of the data integral to 

characterizing dose-response 

relationships. In some instances, this 

group will consist of a handful of 

studies. In other instances, where there 

are multiple toxicity endpoints, there 

may be more studies that are crucial to 

characterizing dose-response 

relationships. In some other cases, there 

may be a large number of studies that 

are used to characterize a dose-response 

relationship (e.g., where the doseresponse is based on a meta-regression 

of epidemiology studies). However, not 

all of these studies would be considered 

pivotal science (see Section III.C.6 of 

this preamble for the definition of 

‘‘pivotal science’’). 

Based on comments and other 

considerations, the EPA is concentrating 

its efforts in the final rule to increase 

transparency on dose-response data, as 

the dose-response data are discrete and 

the dose-response assessment is a welldefined and impactful step in the 

quantitative assessment of risk. This 

final rule provides an important step in 

furthering progress toward maximizing 

transparency and will provide insight 

for future statute-specific requirements. 

Consistent with this targeted focus, the 

EPA is replacing the proposed 

definition of ‘‘dose-response data and 

models’’ at 40 CFR 30.2 with a 

definition of ‘‘dose-response data’’ (see 

Section III.C of this preamble). 

C. Definitions 

The 2018 proposed rule included 

proposed definitions for ‘‘dose-response 

data and models,’’ ‘‘pivotal regulatory 

science,’’ ‘‘regulatory decisions,’’ 

‘‘regulatory science,’’ and ‘‘research 

data.’’ Some commenters stated that 

several of the proposed definitions were 

unclear, including some that seemed to 

overlap (e.g., ‘‘pivotal regulatory 

science’’ and ‘‘regulatory science’’). 

Some commenters also stated that 

certain terms used in the proposed 

regulatory requirements were not clear 

and should be defined. 

In response to these comments on the 

2018 proposed rule, the EPA proposed 

in the 2020 SNPRM definitions for 

‘‘capable of being substantially 

reproduced,’’ ‘‘data,’’ ‘‘independent 

evaluation,’’ ‘‘models,’’ ‘‘publicly 

available,’’ and ‘‘reanalyze.’’ In the 2020 

SNPRM, the EPA also proposed a 

definition of ‘‘influential scientific 

information’’ to comport with the 

proposed expansion of the applicability 

of the rulemaking to influential 

scientific information. 

Based on a consideration of the public 

comments on both the 2018 proposed 

rule and the 2020 SNPRM, the EPA is 

finalizing the definitions at 40 CFR 30.2 

as follows. 

1. Capable of being substantially 

reproduced, independent validation, 

and reanalyze. In the 2018 proposed 

rule, the EPA used the term ‘‘replicate’’ 

in the proposed regulatory text at 40 

CFR 30.5 but did not define it at 40 CFR 

30.2. Proposed 40 CFR 30.5 read, in 

pertinent part, ‘‘[i]nformation is 

considered ‘publicly available in a 

manner sufficient for independent 

validation’ when it includes the 

information necessary for the public to 

understand, assess, and replicate 

findings . . . .’’ Some commenters 

contended that the EPA was not clear 

about what it meant by the term 

‘‘replicate’’ and interpreted the term 

‘‘replicate’’ in several different ways. 

For example, some commenters asserted 

that the EPA used the term ‘‘replicate’’ 

but actually meant ‘‘reanalyze.’’ The 

EPA finds that these comments have 

merit and is clarifying that the intent of 

the term in the proposed regulatory text 

at 40 CFR 30.5 was ‘‘reanalyze’’ rather 

than ‘‘replicate.’’ In the 2020 SNPRM, 

the EPA proposed using the term 

‘‘reanalyze’’ instead of ‘‘replicate’’ and 

proposed at 40 CFR 30.2 a definition for 

‘‘reanalyze.’’ Given that proposed 40 

CFR 30.5 also included the term 

‘‘independent validation’’ and that this 

term directly relates to ‘‘replicate,’’ the 

EPA also proposed a definition at 40 

CFR 30.2 for this term. The proposed 

definition of ‘‘independent validation’’ 

included the term ‘‘capable of being 

substantially reproduced.’’ The EPA 

also defined this term because it was an 

important component of the definition 

of ‘‘independent validation.’’ 

While commenters generally 

supported the inclusion of the proposed 

definitions for ‘‘capable of being 

substantially reproduced,’’ 

‘‘independent validation,’’ and 

‘‘reanalyze,’’ some commenters 

addressed aspects of the proposed 

definitions and suggested modifications. 

One commenter suggested replacing the 

term ‘‘validation’’ with ‘‘verification’’ 

because they asserted the term 

‘‘validation’’ has specific meanings in 

the context of assay development and in 

the context of model development. The 

EPA understands that the term 

validation is used differently in some 

scientific disciplines than the EPA has 

defined it. However, for the purposes of 

this rule, the EPA has defined validation 

in terms of independent reanalysis. 

Another commenter contended that 

the proposed definition of ‘‘independent 

validation’’ was inconsistent with the 

remainder of the proposal because it 

restricts the concept of ‘‘independent 

validation’’ to ‘‘subject matter experts 

who have not contributed to the 

development of the study,’’ rather than 

the public as was the stated intent of the 

rule. Because this rule is about scientific 

data, the EPA finds it unlikely that 

without the necessary expertise, one 

could reasonably reanalyze the doseresponse data underlying pivotal 


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science. This final rule does not 

preclude the public from engaging 

subject matter experts to determine 

whether a study can be independently 

validated. Also, the definition cannot be 

considered solely in isolation. The 

regulatory text in which the term is used 

informs the extent of the availability of 

dose-response data underlying studies. 

Specifically, 40 CFR 30.5 requires, in 

part, that the dose-response data 

underlying studies that the EPA will 

consider as pivotal science be available 

in a manner sufficient for independent 

validation. Scientific information is 

considered available in a manner 

sufficient for independent validation 

when it includes the information 

necessary to understand, assess, and 

reanalyze findings. The efficacy of the 

reanalysis will depend on the expertise 

of the person conducting the reanalysis. 

One commenter noted that the term 

‘‘reproduced’’ in the proposed 

definition of ‘‘capable of being 

substantially reproduced’’ and the use 

of ‘‘capable of being substantially 

reproduced’’ in the proposed definition 

of ‘‘independent validation,’’ were 

inconsistent with the description of 

reproduce in the 2020 SNPRM preamble 

and the NAS Workshop Report (Ref. 26). 

The commenter contended that this 

adds confusion. Another commenter 

asserted that there is insufficient 

guidance or standards for what the term 

‘‘substantially’’ means or who will make 

the determination (e.g., scientific staff 

with oversight of an EPA scientific 

advisory panel). Another commenter 

stated that there were inconsistencies 

with the proposed definitions for the 

terms ‘‘capable of being substantially 

reproduced’’ and ‘‘reanalyze.’’ 

Commenters asserted that the former 

proposed definition specifies the use of 

‘‘identical methods,’’ whereas the latter 

proposed definition specifies the use of 

the ‘‘same or different’’ methods. 

The EPA finds that these comments 

have merit. The EPA is modifying the 

definition of ‘‘independent validation’’ 

in the final rule by replacing ‘‘capable 

of being substantially reproduced’’ with 

‘‘produced.’’ The EPA will not finalize 

the proposed 40 CFR 30.2 definition of 

‘‘capable of being substantially 

reproduced’’ because the term is not 

used in the final rule’s definition of 

‘‘independent validation’’ or elsewhere 

in 40 CFR 30. As a result, 

‘‘substantially’’ will not need to be 

defined or described in the final rule. 

The EPA is also modifying the 

definition of ‘‘reanalyze’’ to specify the 

use of the same methods because as 

proposed it specified the use of the 

‘‘same or different’’ methods. This 

change was made so that the definition 

would be consistent with the final rule’s 

definition of ‘‘independent validation.’’ 

2. Data and models. In the 2020 

SNPRM, the EPA proposed a definition 

of ‘‘data’’ in response to comments on 

the 2018 proposed rule, contending that 

a definition for this term was needed to 

clarify the applicability of the 

rulemaking. Commenters requested that 

the EPA clarify which stage of data 

would need to be available to allow for 

independent validation. The stage of 

data that the EPA identified in the 

proposed 40 CFR 30.2 definition of 

‘‘data’’ is based on the discussion of the 

different stages of data in the NAS 

Workshop Report (Ref. 26). The 2020 

SNPRM adapted the description of the 

stage of data from the NAS Workshop 

Report (Ref. 26) that was data at the 

appropriate level of detail to allow for 

independent validation via reanalysis. 

Several commenters asserted that the 

proposed definition of ‘‘data’’ was so 

broad that it could include potentially 

any information. One commenter 

contended that as published scientific 

results are often the final steps in a 

process involving several processing 

and analysis steps, the proposed 

definition of ‘‘data’’ definition did not 

identify what intermediate step of data 

processing would be subject to this rule. 

The commenter noted that determining 

which of the multiple data processing 

and analysis steps that should be used 

would differ from study to study. 

Another commenter suggested that the 

EPA should identify the actual final 

dataset used in statistical analysis as the 

appropriate stage of data to be made 

available. 

As the EPA described in the 2020 

SNPRM, there are different stages of 

data. The EPA presented the different 

stages described in the NAS Workshop 

Report (Ref. 26), ‘‘There are raw data, 

which come straight from the survey or 

the experiment. There are cleaned-up 

data, which consist of the raw data 

modified to remove obvious errors.’’ 

(These are the data that are ready to be 

analyzed to extract relevant 

information.) ‘‘There are processed data, 

which are data that have been computed 

and analyzed to extract relevant 

information. There is the final clean 

data set that is provided with a 

publication.’’ Since the purpose of 40 

CFR 30.5 is to determine the 

consideration to afford to studies based 

on, among other factors, the availability 

of the underlying dose-response data 

that would support independent 

validation via reanalysis of the data 

underlying pivotal science, the 

appropriate stage of data would not be 

the processed data (data that have been 

computed and analyzed to extract 

relevant information) or the final clean 

data set that is provided with a 

publication. At these two stages of data, 

the analysis has already been 

conducted, and the results have already 

been determined. In order to determine 

if these results are valid, data that had 

not already been computed and 

analyzed are needed. 

In this final rule, the EPA is not 

identifying a specific step in a multistep analysis as the stage of data that 

would be sufficient for independent 

validation through reanalysis because 

this would be overly prescriptive and 

not informative. As noted by 

commenters, the step at which the final 

clean data set will be generated will 

vary from study to study. The level of 

detail required would be that needed for 

a separate party to reanalyze the study. 

The appropriate step is where the data 

are ready to be analyzed to extract 

relevant information. 

One commenter requested that the 

EPA introduce and define a new term, 

‘‘validated data,’’ which are the data 

with the proper level of quality 

assurance. While the EPA routinely 

conducts quality assurance to ensure 

that data are acceptable for use, the EPA 

does not see the need to create a 

separate definition. The focus of this 

rulemaking is the independent 

validation of the results of studies 

underlying pivotal science, not the 

quality assurance of the data itself. 

Some commenters contended that the 

EPA should define ‘‘data’’ as the raw 

data in which obvious errors have not 

been removed. Other commenters stated 

that raw data in which obvious errors 

have not been removed would result in 

skewed analyses for third parties not 

familiar with the data collection 

process. Given concerns about 

potentially skewed analyses, the final 

definition of ‘‘data’’ maintains the stage 

of data in which obvious errors have 

been removed. 

Some commenters also requested that 

the EPA define ‘‘model’’ to clarify the 

applicability of the rulemaking. In the 

2020 SNPRM, the EPA proposed a 

definition of ‘‘model’’ at 40 CFR 30.2, 

but the Agency is not finalizing the 

definition of ‘‘model’’ because this 

regulation applies only to dose-response 

data (see Section III.B of this preamble). 

3. Dose-response data. In the 2018 

proposed rule, the EPA proposed a 

definition of ‘‘dose-response data and 

models.’’ The EPA did not receive 

significant comment on the definition of 

‘‘dose-response data and models’’ itself. 

However, as discussed in Section III.B 

of this preamble, this final rule applies 

to dose-response data, and thus the EPA 

is not finalizing a definition for ‘‘doseVerDate Sep<11>2014 16:19 Jan 05, 2021 Jkt 253001 PO 00000 Frm 00041 Fmt 4700 Sfmt 4700 E:\FR\FM\06JAR1.SGM 06JAR1

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10For example, see the Environmental Protection 

Agency Annual Report on Peer Review Fiscal Year 

2017 (October 1, 2016–September 30, 2017) that the 

Agency submitted to OMB, https://cfpub.epa.gov/ 

si/EPA%20FY%202017%20Annual%20Peer%20

Review%20Report.pdf. Each annual report 

identifies influential scientific information and 

highly influential scientific assessments. 

response data and models.’’ Rather, 

consistent with the applicability of this 

final rule, the EPA is finalizing a 

definition of ‘‘dose-response data’’ that 

is specific to the relationship between a 

dose or exposure and an effect. 

4. Influential scientific information. In 

the 2020 SNPRM, the EPA proposed 

expanding the scope of the 2018 

proposed rule to include influential 

scientific information and proposed to 

define ‘‘influential scientific 

information’’ as ‘‘scientific information 

the Agency reasonably can determine 

will have or does have a clear and 

substantial impact on important public 

policies or private sector decisions,’’ 

consistent with the definition of 

‘‘influential scientific information’’ 

provided in the OMB Final Information 

Quality Bulletin for Peer Review (Ref. 

8). 

The EPA received public comments in 

support of and against the Agency’s 

proposed 40 CFR 30.2 definition of 

‘‘influential scientific information.’’ 

Some commenters believed that the 

proposed definition was too broad to be 

useful and, as a result, would apply to 

all scientific documents produced by 

the EPA. Other commenters believed 

that the proposed definition was too 

narrow and would not adequately 

capture the types of information that 

may be considered influential. 

The EPA finds that these comments 

have merit, in part. The definition of 

‘‘influential scientific information’’ at 

proposed 40 CFR 30.2 in the 2020 

SNPRM is the same definition as in the 

OMB Final Information Quality Bulletin 

for Peer Review (Ref. 8). The EPA 

proposed to adopt this definition 

because it intended the scope to be 

consistent with how that term has been 

interpreted and applied in the context of 

peer review.10 Given that the definition 

is both established and has been 

routinely applied by the EPA, the EPA 

disagrees with the suggestion that the 

term is inherently too narrow or too 

broad. Rather than modify the proposed 

40 CFR 30.2 definition of ‘‘influential 

scientific information,’’ the EPA is 

modifying 40 CFR 30.3 in the final rule 

to clarify the Agency’s intent that the 

requirements in 40 CFR 30.3 apply to 

influential scientific information, unless 

the influential scientific information is 

exempted from peer review 

requirements as described in Section IX 

of the OMB Final Information Quality 

Bulletin for Peer Review (Ref. 8). 

Consistent with this approach, the EPA 

is finalizing the definition of 

‘‘influential scientific information’’ as 

proposed in the 2020 SNPRM. 

5. Pivotal science. In the 2020 

SNPRM, the EPA introduced the term 

‘‘pivotal science,’’ defined in proposed 

40 CFR 30.2 as ‘‘the specific scientific 

studies or analyses that underly [sic] 

influential scientific information.’’ This 

term was proposed as a parallel to 

‘‘pivotal regulatory science,’’ defined in 

40 CFR 30.2 of the 2018 proposed rule 

as ‘‘the specific scientific studies or 

analyses that drive the requirements 

and/or quantitative analysis of EPA 

significant regulatory decisions.’’ 

The EPA received comment on the 

use of ‘‘regulatory’’ in ‘‘pivotal 

regulatory science.’’ Some commenters 

contended that there is no such thing as 

science that is regulatory; rather, there 

is science used to support regulation. 

Some commenters also noted that the 

terms ‘‘pivotal science’’ and ‘‘pivotal 

regulatory science’’ have similar scopes. 

The EPA acknowledges that no 

scientific study is inherently regulatory; 

rather, the EPA uses science to inform 

its significant regulatory actions. In 

order to increase the clarity of this final 

rule, to take into account the similarities 

between the two definitions, and to 

more accurately describe the science 

that the EPA uses, the EPA is removing 

the term ‘‘pivotal regulatory science’’ 

and combining the definitions of 

‘‘pivotal science’’ and ‘‘pivotal 

regulatory science’’ under the single 

term ‘‘pivotal science’’ in 40 CFR 30.2. 

The EPA is responding to comments on 

both terms together. 

Some commenters noted that the 

scope of studies that could be 

considered ‘‘pivotal science’’ was 

unclear but appeared broad. Some 

commenters argued that since properly 

conducted science reviews the entire 

body of scientific evidence, nearly any 

study evaluated could be considered 

‘‘pivotal science.’’ The EPA’s SAB 

suggested that the Agency clarify 

whether ‘‘pivotal science’’ refers to all 

the hazard characterization and doseresponse models that the EPA evaluates 

and captures in its analysis (Ref. 27). 

Other commenters asserted that if the 

EPA interprets ‘‘pivotal science’’ 

broadly to include all studies involved 

in the development of significant 

regulatory actions or influential 

scientific information, implementing 

this rule would be infeasible. 

As discussed in Section III.B of this 

preamble, the EPA finds merit in 

comments that the proposed definition 

for ‘‘pivotal science’’ appeared too broad 

to feasibly implement in this rule. 

Because of the EPA’s commitment to 

basing its decisions on sound science, 

the EPA may review several hundred or 

thousands of scientific studies in the 

development of significant regulatory 

actions or influential scientific 

information. As such, the EPA agrees 

that determining data availability for all 

the studies EPA considers in significant 

regulatory actions and influential 

scientific information may be infeasible 

at this time. Future statute-specific 

rulemakings may be more expansive as 

the EPA continues to make incremental 

progress toward maximizing 

transparency. 

Further, although this rulemaking 

does not require reanalysis of a study’s 

underlying data, the EPA finds that 

limiting the scope of ‘‘pivotal science’’ 

will still provide meaningful and 

impactful opportunity for reanalysis. 

Lewandowsky et al. (2020) evaluated 

the cost-effectiveness of reanalysis 

studies under various scenarios and 

concluded that reanalysis studies are 

most cost-effective when they are 

focused on studies of the greatest 

interest to the scientific community (in 

this study, the number of citations was 

a surrogate for interest) (Ref. 38). This 

finding is consistent with results in 

other studies that found and encouraged 

narrowing the focus of attempted 

reanalysis studies to those studies of 

greater significance (Refs. 37, 39, 40, 

41). 

In this final rule, rather than 

considering all studies that support the 

assessment of the relationship of a dose 

or exposure of a pollutant, contaminant, 

or substance to the magnitude of a 

predicted health or environmental 

impact as ‘‘pivotal science,’’ the EPA is 

balancing transparency and feasibility 

by focusing on those studies that inform 

the quantitative relationship between 

the dose or exposure of a pollutant, 

contaminant, or substance and an effect. 

Thus, ‘‘pivotal science’’ includes only 

those studies that are integral to 

characterizing dose-response 

relationships (e.g., identifying candidate 

PODs). These are the studies that drive 

the requirements or quantitative 

analyses of EPA significant regulatory 

actions or influential scientific 

information. Although this rule takes an 

incremental approach and therefore 

does not include studies informing the 

dose-response modeling (e.g., 

benchmark response selection), studies 

identifying data for toxicokinetic 

adjustments, or studies informing the 

selection of uncertainty factors do not 

drive the requirements or quantitative 

analyses of EPA significant regulatory 

actions or influential scientific 


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information. Future statute-specific 

rulemakings may interpret ‘‘pivotal 

science’’ more broadly. 

This clarified definition of ‘‘pivotal 

science’’ in the final rule is also 

responsive to the SAB’s comments that 

pivotal science should be more focused 

(Ref. 27). Consistent with the intent of 

this rulemaking, the EPA intends to 

clearly identify the studies considered 

pivotal in the documentation at the 

proposed rule stage for significant 

regulatory actions and when influential 

scientific information is disseminated 

for peer review. 

Some commenters also expressed 

confusion regarding how ‘‘pivotal 

science’’ relates to ‘‘best available 

science.’’ One commenter recommended 

that if this rulemaking is intended to 

alter the EPA’s definition and use of the 

best available science, the EPA should 

issue further guidance for public 

comment. To be clear, this rulemaking 

is not intended to modify the Agency’s 

interpretations of ‘‘best available 

science.’’ The EPA will continue to 

consider all peer-reviewed science, 

consistent with existing study quality 

assessment factors and corresponding 

statutory mandates. The EPA will then 

identify and consider ‘‘pivotal science 

in accordance with the provisions of 

this rule,’’ unless the implementation of 

the rule conflicts with statutory 

requirements and associated 

implementing regulations. 

6. Publicly available. In the 2018 

proposed rule, the EPA used the term 

‘‘publicly available,’’ but did not 

propose a definition at 40 CFR 30.2 or 

describe it in the preamble to the 2018 

proposed rule. Some commenters on the 

2018 proposed rule asked the EPA to 

explain what it meant by the term. In 

the 2020 SNPRM, the EPA proposed a 

definition for ‘‘publicly available’’ at 40 

CFR 30.2. 

One commenter stated that the 

proposed definition was vague because 

it did not make clear whether the study 

data itself would proactively be made 

available to members of the public by 

data holders in government sources, 

media sources, or other online sources. 

The definition is not intended to 

describe the mechanism for making the 

information available (i.e., whether the 

information is made available 

proactively or is made available upon 

request). Rather, the definition describes 

whether, given the nature of the 

information, it can be, must be, or is 

already generally available (i.e., where 

the information can be made lawfully 

available from government records, is 

required to be made available by 

government law or regulation, or is 

information that is widely available to 

the general public). 

Another commenter requested that 

the EPA consider data and models to be 

publicly available when they are 

available through restricted access when 

the data includes CBI, proprietary data, 

or PII that cannot be sufficiently deidentified to protect the data subjects. 

The EPA disagrees with the commenter. 

The plain meaning of ‘‘publicly 

available’’ does not include availability 

through restricted access to data that 

includes CBI or PII because there are 

laws that preclude the disclosure of CBI 

or PII to those not authorized for its 

access. Thus, the general public cannot 

access the un-sanitized CBI data or nonanonymized PII data in a manner that 

will allow for independent validation 

through reanalysis. If the public cannot 

access such data, it is not publicly 

available. 

Several commenters contended that 

the proposed definition of ‘‘publicly 

available’’ would introduce a bias 

favoring industry data submitted to the 

EPA. They asserted that industrygenerated studies submitted to the EPA 

pursuant to FIFRA would be considered 

publicly available because they could be 

obtained by the public in response to a 

Freedom of Information Act (FOIA) 

request. However, this does not mean 

that these are immediately or easily 

available to the public. Some 

commenters cited the EPA’s Freedom of 

Information Act Annual Report Fiscal 

Year 2019 (2020), which lists a median 

response time for ‘‘expedited 

processing’’ of FOIA requests by the 

EPA as 493 days (Ref. 42). The EPA 

finds that such comments have merit 

and is modifying the definition in the 

final rule to add the following at the end 

of the definition: ‘‘‘‘the public must be 

able to access the information on the 

date of publication of the proposed rule 

for the significant regulatory action or 

dissemination of the draft influential 

scientific information for public review 

and comment.’’ 

7. Research data. Proposed 40 CFR 

30.2 in the 2018 proposed rule included 

a definition of ‘‘research data.’’ In the 

2020 SNPRM, the EPA deleted the 

proposed definition of ‘‘research data.’’ 

While one commenter on the 2020 

SNPRM noted that the exclusions in the 

proposed definition of ‘‘research data’’ 

of trade secrets and personal and 

medical information were not 

incorporated into the proposed 

definition of ‘‘data,’’ commenters did 

not request that the EPA maintain a 

definition of ‘‘research data.’’ The EPA 

is not including a definition of 

‘‘research data’’ in this final rule given 

that it is finalizing the definition of 

‘‘data.’’ 

8. Significant regulatory actions. In 

the 2018 proposed rule, the EPA defined 

the term ‘‘regulatory decisions’’ as final 

regulations determined to be significant 

regulatory actions under Executive 

Order (E.O.) 12866, Regulatory Planning 

and Review. Some commenters stated 

that the use of regulatory decisions was 

confusing given that the term was only 

intended to apply to a subset of 

regulations. The EPA agrees with these 

comments, and to clarify the definition, 

the Agency is changing the term from 

‘‘regulatory decisions’’ to ‘‘significant 

regulatory actions’’ in the final rule. 

9. Science that serves as the basis for 

informing a significant regulatory 

action. In the 2018 proposed rule, the 

EPA proposed to define the term 

‘‘regulatory science.’’ A number of 

commenters expressed confusion over 

both the meaning and scope of this 

proposed term. One commenter noted 

that other Federal agencies have defined 

‘‘regulatory science.’’ For example, the 

U.S. Food and Drug Administration 

(FDA) has described ‘‘regulatory 

science’’ as ‘‘the science of developing 

new tools, standards, and approaches to 

assess the safety, efficacy, quality, and 

performance of all FDA-regulated 

products’’ (Ref. 43).This commenter 

suggested that a simplified definition 

would be ‘‘regulatory science consists of 

the scientific segment of the regulatory 

process.’’ The EPA acknowledges that 

the term ‘‘regulatory science’’ may be 

confusing because it suggests either that 

the term refers to a scientific discipline 

of regulatory decision-making (akin to 

FDA’s description), or that the EPA 

considers some science inherently 

regulatory. Neither of these 

interpretations reflects the Agency’s 

intent in defining this term. The EPA 

considers the breadth of scientific 

evidence in its rulemakings; while this 

scientific evidence informs policy 

decisions, the EPA’s consideration of 

the science does not make it ‘‘regulatory 

science.’’ To reflect this fact, in the final 

rule the EPA is changing the proposed 

term ‘‘regulatory science’’ to ‘‘science 

that serves as the basis for informing a 

significant regulatory action.’’ 

In the 2018 proposed rule, the EPA 

defined regulatory science as ‘‘scientific 

information, including assessments, 

models, criteria documents, and 

regulatory impact analyses, that provide 

the basis for EPA final significant 

regulatory actions.’’ Several commenters 

claimed that this definition was vague 

and without discernable meaning. The 

EPA disagrees with the assertion that 

the proposed definition was without 

meaning, but in response to comments 


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is altering the final definition to 

increase clarity. For example, the EPA 

notes that the proposed definition for 

‘‘regulatory science’’ combined both 

general categories of scientific 

information, such as assessments and 

models, with specific examples of EPA 

scientific products, such as criteria 

documents and regulatory impact 

analyses. The EPA acknowledges that 

this may increase confusion and is 

therefore limiting the final definition to 

general categories. As such, the EPA is 

altering the definition of ‘‘science that 

serves as the basis for informing a 

significant regulatory action’’ in 40 CFR 

30.2 to mean ‘‘studies, analyses, models, 

and assessments of a body of evidence 

that provide the basis for EPA 

significant regulatory actions.’’ 

Examples of models include those used 

in regulatory impact analyses. Examples 

of assessments of a body of evidence 

include risk assessments, hazard 

identifications, Integrated Risk 

Information System (IRIS) assessments, 

and criteria documents. 

Other commenters expressed 

confusion over the scope of what 

constitutes science that serves as the 

basis for informing a final significant 

regulatory action, as defined in the 

proposed rule. One commenter asserted 

that the phrase ‘‘provides the basis’’ 

means that science that serves as the 

basis for informing a final significant 

regulatory action could be all the 

science considered, relied upon, and 

included in the administrative record of 

a rulemaking by the EPA. The EPA 

agrees with this and clarifies in the final 

rule that the scope of science that serves 

as the basis for informing a significant 

regulatory action is equivalent to the 

science included in the public docket as 

part of a rulemaking, but not all of that 

body of science would typically be 

considered ‘‘pivotal science.’’ 

D. Applicability of the Rule 

In the 2018 proposed rulemaking, the 

EPA proposed to apply the requirements 

of this rulemaking on significant 

regulatory decisions. The EPA then 

solicited comment on whether the 

requirements of this rulemaking should 

apply to (1) other stages of the 

rulemaking process; (2) a narrower 

scope of coverage; and (3) certain 

categories of regulatory actions, such as 

individual party adjudications, 

enforcement activities, or permit 

proceedings or other agency actions. In 

the 2020 SNPRM, the EPA proposed to 

expand the applicability of this 

rulemaking to include influential 

scientific information. 

The EPA received significant 

comment on the proposed applicability 

of this rulemaking to significant 

regulatory decisions and influential 

scientific information. Some 

commenters supported the proposed 

applicability, while other commenters 

disagreed with it. 

A few commenters addressed the 

potential for expansion or narrowing of 

the scope of the rule to include other 

actions in addition to final significant 

regulatory decisions and influential 

scientific information. Of the few 

commenters that explicitly addressed 

potential expansion beyond the 

proposed rulemaking, a majority 

focused on recommendations to include 

the science underlying Integrated 

Science Assessments (ISAs) and IRIS 

assessments. A few commenters 

expressed support to expand the 

proposed rulemaking to include one or 

more of the following: TSCA risk 

evaluations; CERCLA remedial actions; 

RCRA corrective actions; as well as 

assessments and actions under the 

CWA. Additional comments 

recommended expansion of the scope of 

the proposed rulemaking to include 

enforcement and permitting actions, as 

well as agency guidance documents. 

Some commenters supported applying 

the requirements of this rulemaking to 

proposed rules and advance notices of 

proposed rulemakings. Other 

commenters specifically opposed 

expanding the proposed rulemaking to 

include the aforementioned actions. 

Additionally, some commenters 

recommended narrowing the scope to 

only rulemakings subject to the 

Congressional Review Act or 

economically significant regulatory 

actions under E.O. 12866 (i.e., those 

rules that ‘‘have an annual effect on the 

economy of $100 million or more or 

adversely affect in a material way the 

economy, a sector of the economy, 

productivity, competition, jobs, the 

environment, public health or safety, or 

State, local, or tribal governments or 

communities’’). 

Some of the assessments that 

commenters suggested should be subject 

to the requirements of this rulemaking 

are categorized as influential scientific 

information. The EPA notes that many 

assessments categorized as influential 

scientific information support 

rulemakings and other actions under 

several environmental statutes that the 

EPA administers. For example, the ISA 

for lead and the IRIS assessment for 

trichloroethylene have been used in a 

variety of actions (including those that 

are not significant regulatory actions) 

under TSCA, RCRA, and the CAA. IRIS 

assessments are routinely used under 

the CAA, RCRA, and CERCLA. By 

finalizing the scope rule to include 

influential scientific information, the 

Agency is applying the applicability of 

the rule to an important category of 

scientific assessments that influence a 

wide range of EPA regulatory actions. 

The EPA sees no need to include the 

proposed rule stage of final significant 

regulatory actions in the regulatory text 

because as a practical matter proposed 

rules must comply with this final rule 

before being finalized. As a general 

matter, the EPA does not introduce the 

studies and analyses it relies on for a 

rulemaking at the final rule stage. The 

scientific basis for a rulemaking is 

provided for public review and 

comment in the public docket when the 

proposed rule is issued or, if 

subsequently added to the docket, 

through a separate opportunity for 

public comment. Advance notices of 

proposed rulemakings are not consistent 

with the purpose of this rule, given their 

preliminary nature and frequent focus 

on soliciting comments on a regulatory 

issue or approach. 

Transparency is important in ensuring 

that the decisions the EPA makes are 

based on sound science. The EPA is 

finalizing the applicability of this rule to 

significant regulatory actions and 

influential scientific information 

because of the potential broad impact of 

these actions and assessments on 

American lives and livelihoods. The 

EPA is not applying this rulemaking to 

permit proceedings, site-specific 

actions, or enforcement actions because 

these actions are typically focused on 

individual regulated entities. 

E. Availability of Dose-Response Data 

In the 2018 proposed rule, the EPA 

proposed to require at 40 CFR 30.5 that 

‘‘[w]hen promulgating final significant 

regulatory decisions, the Agency shall 

ensure that dose-response data and 

models underlying pivotal regulatory 

science are publicly available in a 

manner sufficient for independent 

validation.’’ The EPA received a large 

number of comments stating that the 

approach in the 2018 proposed rule 

would likely preclude the use of valid 

data and models from consideration as 

pivotal science. The comments 

indicated that the proposed requirement 

to ensure data and models are publicly 

available in a manner sufficient for 

independent validation would prevent 

the use of data and models that include 

CBI, proprietary data, and PII that 

cannot be sufficiently de-identified to 

protect the data subjects, as well as 

many older studies. In response to such 

comments, in the 2020 SNPRM, the EPA 

proposed a modified version of the 2018 

proposed regulatory text at 40 CFR 30.5. 

Proposed 40 CFR 30.5 would allow 


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agency consideration of studies with 

restricted access to data and models that 

have CBI, proprietary data, or PII that 

cannot be sufficiently de-identified to 

protect the data subjects. For all other 

studies, data and models should be 

publicly available if the studies were to 

be used as pivotal regulatory science or 

pivotal science. In the 2020 SNPRM, the 

EPA also proposed an alternative. Under 

the alternative 40 CFR 30.5 proposal, 

when promulgating significant 

regulatory decisions or developing 

influential scientific information, the 

Agency would, other things equal, give 

greater consideration to studies where 

the underlying data and models are 

available in a manner sufficient for 

independent validation either because 

the information is publicly available or 

available through tiered access when the 

data include CBI, proprietary data, or PII 

and appropriate techniques have been 

used to reduce the risk of reidentification. In the 2020 SNPRM, the 

Agency proposed that in developing the 

final significant regulatory decision or 

influential scientific information, the 

EPA would identify those studies that 

were given greater consideration and 

provide a short description of why and 

how greater consideration was given. 

A few commenters contended that 40 

CFR 30.5 as proposed in the 2018 

proposed rule was superior to proposed 

40 CFR 30.5 in the 2020 SNPRM and the 

alternative proposed 40 CFR 30.5 in the 

2020 SNPRM. The commenters asserted 

that privacy or confidentiality should 

not have priority over transparency. 

They further asserted that the 

approaches in the 2020 SNPRM would 

impose substantial limits on the effect of 

the rule since privacy, confidentiality, 

and restricted access are all concepts 

and practices that inhibit full 

transparency. 

Some commenters supported the 

categorical approach taken in proposed 

40 CFR 30.5 in the 2020 SNPRM in 

which pivotal science would need to be 

available for independent validation. A 

few commenters suggested that it be 

expanded to apply to all studies, not 

only those that are pivotal science. 

Other commenters contended the 

proposed 2020 SNPRM approach was 

flawed because it would exclude from 

consideration valid scientific studies for 

which the underlying data at the stage 

required by this regulation are 

unavailable, regardless of whether the 

studies have been peer reviewed or 

would be considered part of the ‘‘best 

available science’’ under the 

environmental statutes that EPA 

administers that require the use of ‘‘best 

available science.’’ These commenters 

stated that such a categorical exclusion 

is inconsistent with current scientific 

standards and the requirements of the 

environmental statutes that the EPA 

administers. Other commenters noted 

that there are a variety of reasons, 

including the age of a study, why the 

underlying data at the stage required by 

this rulemaking would not be available, 

publicly or otherwise, for independent 

validation. 

Some commenters supported and 

other commenters opposed alternate 

proposed 40 CFR 30.5 in which the 

Agency would, all else being equal, give 

greater consideration to studies where 

the underlying data and models are 

available in a manner sufficient for 

independent validation. Some 

commenters stated that this was a 

reasonable way to consider transparency 

because studies would be assessed on a 

case-by-case basis and valid studies 

would not be categorically excluded. 

Other commenters did not support 

alternate proposed 40 CFR 30.5 because 

they contended there is no scientific 

justification for a rule that directs the 

EPA to selectively give greater 

consideration to certain studies over 

others based on data availability. 

Upon consideration of the comments, 

the EPA agrees that it is important not 

to categorically exclude any study 

because the data underlying a study at 

the stage required by this rulemaking 

may not be available for independent 

validation. Therefore, the EPA is not 

finalizing the primary proposal in the 

2020 SNPRM that would have 

categorically required that for studies to 

be considered pivotal science, the 

underlying data would need to be 

available for independent validation. 

However, given that transparency is an 

important aspect of EPA’s regulatory 

actions and assessments, it should be an 

important consideration in how the 

Agency considers pivotal science. As 

described in 40 CFR 30.5 of the final 

rule, the EPA will rely on the highest 

quality, most relevant studies available 

in determining the potential for hazard 

due to exposure to a pollutant, 

contaminant, or substance. Where there 

is convincing and well substantiated 

evidence to support a relationship 

between exposure and effect, the EPA 

will identify those studies—based on 

the exposure situation being addressed, 

the quality of the studies, the reporting 

adequacy, and the relevance of the 

endpoints—that would inform a doseresponse assessment for those effect 

endpoints. From that subset, the specific 

dose-response studies or analyses that 

drive the requirements or quantitative 

analyses of an EPA significant 

regulatory action or influential scientific 

information will be identified as pivotal 

science. 

Further, the EPA is finalizing the 

approach that gives greater 

consideration to pivotal science whose 

underlying dose-response data are 

publicly available or available through 

restricted access. Restricted or tiered 

access in this final rule means that the 

underlying dose-response data are 

available through a data sharing 

mechanism, such as through an 

agreement with the originating author or 

institution, access to a refined or 

redacted dataset that anonymizes the 

more sensitive portions of the 

analyzable dataset, a restricted access 

data repository or secure data enclave, 

or some other mechanism (e.g., Data Use 

Agreements) that allows a qualified 

subject matter expert access to enough 

data to support independent validation 

while still protecting sensitive 

information. 

Some commenters argued that the 

EPA did not sufficiently explain how it 

will identify ‘‘pivotal science.’’ For 

example, one commenter stated that the 

EPA did not explained what it means 

for a study to ‘‘underly’’ [sic] influential 

scientific information or to ‘‘drive the 

requirements’’ of final significant 

regulatory actions. Some commenters on 

the 2018 proposed rule asked for the 

EPA to clarify in what stage of the 

review process the Agency would 

identify pivotal science. In the 2020 

SNPRM, the EPA explained, ‘‘under this 

[proposed] regulation EPA would 

continue to use standard processes for 

identifying, evaluating, and reviewing 

available data, models, and studies. 

When the Agency has potentially 

identified multiple key studies or 

models of similar quality that could 

drive its subsequent decisions, the 

Agency will investigate the availability 

of the underlying data.’’ In response to 

the 2020 SNPRM, one commenter 

suggested the EPA provide a transparent 

explanation of how and why studies are 

determined to be pivotal science over 

others. A commenter also argued that if 

the EPA interprets ‘‘pivotal science’’ 

narrowly (i.e., not as all the studies 

included in the weight of evidence), this 

would introduce risk of selecting 

‘‘pivotal science’’ in a biased manner 

without sufficient accountability. 

Another commenter recommended that 

the EPA establish criteria for 

designating studies as pivotal science. 

The EPA disagrees with the 

proposition that designating a set of key 

studies as ‘‘pivotal science’’ will 

necessarily be biased or without 

accountability. The EPA follows an 

objective, unbiased process for 

identifying and evaluating scientific 


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studies and already identifies key or 

pivotal studies in some of its actions 

(e.g., IRIS assessments). The EPA 

intends to issue implementation 

guidelines and statute-specific 

rulemakings that will further describe 

these criteria and how the EPA will 

identify pivotal science in its 

assessments and rulemakings. In 

general, the EPA will rely on the highest 

quality, most relevant studies available 

in determining the potential for hazard 

due to exposure to a pollutant, 

contaminant, or substance. Where there 

is convincing and well substantiated 

evidence to support a relationship 

between exposure and effect, the EPA 

will identify a subset of those studies 

based on the exposure situation being 

addressed, the quality of the studies, the 

reporting adequacy, and the relevance of 

the endpoints that would inform a doseresponse assessment for those effect 

endpoints and drive the requirements 

and/or quantitative analyses of an EPA 

final significant regulatory action or 

influential scientific information will be 

identified as pivotal science. 

Further, the EPA intends to 

promulgate regulations under the 

environmental statutes that the EPA 

administers to further clarify how the 

Agency will apply the definition of 

‘‘pivotal science’’ in specific programs 

authorized under those statutes (e.g., 

CAA, CWA, SDWA, RCRA, FIFRA, 

TSCA, EPCRA). The specific criteria for 

determining ‘‘pivotal science’’ may 

necessarily be specific to the 

authorizing statute, as well as the 

significant regulatory action or the 

influential scientific information. The 

EPA intends to explain in each 

significant regulatory action and for 

influential scientific information how 

the pivotal studies were identified. 

In response to comments on the 

meaning of ‘‘drive the requirements 

and/or quantitative analysis,’’ these are 

the studies that are integral to 

quantitatively characterizing doseresponse relationships for the toxicity 

endpoints that underlie the 

requirements or analyses of EPA 

significant regulatory actions or 

influential scientific information. The 

EPA may further interpret the meaning 

of ‘‘drive,’’ and describe the process for 

designating key studies as pivotal 

science in subsequent implementation 

guidelines and/or statute-specific 

rulemakings. 

Some commenters stated that the EPA 

did not explain what was meant by 

‘‘other things being equal.’’ Some of 

these commenters requested clarity on 

what factors in addition to transparency 

would be considered. Some specific 

suggestions from commenters include 

that EPA should give consideration to 

quality studies that evaluate a range of 

models, that are scientifically sound for 

the intended use, and that have study 

‘‘characteristics (e.g., sample size, 

confidence intervals of results, or 

overall methods validity) [that] may 

compensate for any lack of full 

transparency.’’ In consideration of these 

and other public comments, the EPA 

developed additional factors that clarify 

specific technical factors that it may 

consider in balancing study quality and 

data availability. Although the EPA is 

prioritizing transparency in pivotal 

science, the Agency also recognizes that 

there will be instances where the 

underlying dose-response data of 

pivotal science is unavailable for 

independent validation. In order to 

ensure that the Agency maintains a 

strong scientific basis for its decisionmaking, the availability of underlying 

dose-response data should be 

considered as long as other significant 

technical considerations can provide 

some level of certainty or confirmation 

of a study’s conclusions, importance, 

and applicability, even in the absence of 

maximum transparency. Though EPA’s 

list of factors herein is not exhaustive or 

exclusive, the EPA has identified 

several factors in 40 CFR 30.5(d) that 

balance some of the important technical 

considerations the EPA will consider in 

addition to data availability and that are 

particularly relevant to the stage of the 

analysis where dose-response data are 

used. These factors are intended to 

assist the EPA in determining the 

consideration to afford to pivotal 

science with underlying dose-response 

data that are not available for 

independent validation. The final rule 

requirements and the consideration of 

these factors apply to any data used in 

characterizing the relationship between 

the amount of dose or exposure to a 

pollutant, contaminant, or substance 

and an effect, regardless of the direction 

of that effect. Because study quality 

factors (including soundness, 

applicability and utility, clarity and 

completeness, uncertainty and 

variability, and evaluation and review) 

would have already been evaluated at 

an earlier stage in the assessment 

process (see 40 CFR 30.5(b)), the EPA 

envisions that at the stage of the 

evaluation that utilizes the factors 

described in 40 CFR 30.5(d), the studies 

to be evaluated would generally be of 

the highest quality available. 

Some of the factors in 40 CFR 30.5(d) 

are intended to be evaluated for pivotal 

science with underlying data that are 

not available for independent validation 

relative to pivotal science with 

underlying data that are available for 

independent validation. For example, 

when assessing studies, the EPA may 

determine that greater consideration 

should be given to a study with 

underlying data that are unavailable for 

independent validation when that study 

is of higher quality compared to a 

medium-quality study with underlying 

data that are available for independent 

validation (factor 1), the conclusions of 

the significant regulatory action or 

influential scientific information are or 

are not highly sensitive to the exclusion 

of the study for which the underlying 

data are not available for independent 

validation (factor 3), the study with data 

unavailable for independent validation 

was better fit for the purpose of the EPA 

assessment (factor 4), or the results of 

the study for which the underlying data 

are not available are supported by other 

scientific evidence, such as mechanistic 

data (factor 6). 

Importantly, the factors in 40 CFR 

30.5(d) do not apply to other stages in 

the assessment process (although they 

are relevant to determining whether to 

grant an exemption under 40 CFR 30.7, 

as further explained below). For 

example, the consideration for 

exposures that were conducted at more 

environmentally relevant exposure 

concentrations (factor 5) does not 

suggest that epidemiological studies 

will automatically be given greater 

weight than laboratory studies. The EPA 

will continue to use established 

guidelines for identifying and 

integrating evidence and will use the 

factors in 40 CFR 30.5(d) only when 

evaluating the data availability 

requirements of this rule (or when 

determining whether to grant an 

exemption under 40 CFR 30.7, as further 

explained below). In addition, not all of 

these factors will be applicable to all 

studies or assessments. For example, 

some pollutants, chemicals, or 

substances may have unique scientific 

considerations (factor 7), such as the 

valence state of a metal compound or 

endogenous contributions to internal 

concentrations, that may not be relevant 

for other pollutants, chemicals, or 

substances. Therefore, the weight 

afforded to each factor by the EPA may 

vary by assessment, and how those 

factors were considered will be 

documented in the assessment. If two 

studies, one with and one without 

available data and are relatively equal 

with respect to the study quality factors 

in 40 CFR 30.5(b), the study where the 

underlying data is available will be 

given greater consideration and the 

weight of the other study will be based 

on an assessment of the factors in 40 


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CFR 30.5(d). In this way, the EPA will 

balance the importance of transparency 

with the need to maintain a strong 

scientific basis for its assessments. 

This final rule requires the 

consideration of the factors in 40 CFR 

30.5(d) when assessing pivotal studies 

for which the dose-response data are not 

available for independent validation. 

The EPA may adapt these factors in 

upcoming statute-specific rulemakings, 

as appropriate, for significant regulatory 

actions under the different 

environmental statutes that the EPA 

administers. How scientific information 

is to be considered varies among the 

different environmental statutes and 

sometimes within an individual statute. 

Interpretation of the assessment factors 

will be tailored to the specific 

circumstances and the specific 

environmental statutes. 

Some commenters asserted that the 

2018 proposed rule and the 2020 

SNPRM failed to explain how historical 

data, which may have been collected 

under different policies and procedures, 

will be treated. These commenters noted 

that underlying dose-response data may 

have been lost for older studies due to 

record retention schedules. Some 

commenters also contended that a 

significant amount of work would be 

required to locate, curate, and 

retrospectively make datasets available 

for public access. 

The EPA intends to determine the 

extent of the consideration that should 

be given to pivotal studies lacking 

available data on a case-by-case basis. 

The EPA will consider the 

circumstances specific to each such 

study when it applies the factors listed 

in 40 CFR 30.5(d) to that study. The age 

of the data is not a consideration under 

40 CFR 30.5(d), but could be the basis 

for a 40 CFR 30.7 exemption request. 

Some commenters stated that the EPA 

should not have the rulemaking apply 

retrospectively to studies given the 

potential difficulty accessing, reviewing, 

and making data available that were not 

originally intended to be disseminated, 

as would be required by this 

rulemaking. These commenters 

requested that the EPA apply the 

rulemaking provisions only to data and 

models underlying studies generated 

after the promulgation of this rule. 

This final rule applies prospectively 

to significant regulatory actions and 

influential scientific information and 

has no retrospective effect on existing 

(i.e., completed) significant regulatory 

actions or influential scientific 

information. For future, significant 

regulatory actions and influential 

scientific information, the final rule 

applies equally to all dose-response data 

underlying studies used as pivotal 

science, regardless of when the study or 

the data was created. Scientific 

transparency is important regardless of 

the age of the study or the dose-response 

data. 

Some commenters contended that a 

substantial amount of work would be 

required in order to make data 

underlying studies available for 

independent validation, but that the 

EPA has not identified a responsible 

party for this work, nor has it made 

clear the timelines, electronic data 

sharing mechanisms, or how public 

reporting of such availability would be 

achieved, archived, and maintained 

over time. The EPA would like to 

emphasize that this final rule does not 

impose requirements on any entity 

outside of the EPA. This is a rule of 

internal procedures and does not direct 

or require any outside entity or the EPA 

to establish data sharing mechanisms. 

Further, the final rule does not require 

the EPA to collect, store, or publicly 

disseminate dose-response data 

underlying pivotal science. 

Some commenters asserted that 

reproducing findings across similar 

studies is more informative than 

reanalyzing the data from a single study. 

Such commenters noted that confidence 

in the study findings is best gained 

when different groups are studying the 

same thing or are conducting similar 

studies. They asserted that the study 

results could then be averaged, 

compared, and further analyzed. One 

commenter noted that the ability to 

reanalyze the data from a study with 

very poor scientific quality does not 

strengthen the quality of the study. 

Commenters contended that 

reproducing studies (i.e., producing 

something that is very similar to that 

research, but it is in a different medium 

or context) is generally viewed as a 

more informative and resource efficient 

approach to validation of research than 

reanalyzing the data of a particular 

study. Some commenters contended 

that reanalysis of the data and models 

underlying studies is not how to 

determine the quality of a study; rather, 

there are other key aspects of studies 

that are integral to assessing the quality 

of a study. 

Other commenters supported the 

proposed requirement for independent 

validation by reanalysis of data and 

models underlying studies because they 

believe this is key to determining 

whether the science is accurate and of 

high quality. Some commenters 

contended that by reanalyzing the 

underlying data and models, 

independent researchers can evaluate 

the myriad of choices and assumptions 

the original researchers have made 

regarding the data and statistical models 

and the potential introduction of any 

sources of bias. 

While the availability of doseresponse data underlying a study in a 

manner sufficient for independent 

validation is an important component of 

determining the level of consideration 

to afford a study, the EPA agrees that 

availability by itself is not sufficient to 

determine study quality. As explained 

in 40 CFR 30.5(b), the EPA will use 

existing factors (including soundness, 

applicability and utility, clarity and 

completeness, uncertainty and 

variability, and evaluation and review) 

to evaluate study quality. Subsequently, 

after identifying the highest quality, 

most relevant studies that would inform 

a dose-response assessment and 

identifying the availability of pivotal 

science, the EPA would consider the 

additional applicable factors in 40 CFR 

30.5(d) when determining the level of 

consideration to give pivotal science 

where the underlying dose-response 

data are not available for independent 

validation. Further, although the EPA 

agrees with commenters that meaningful 

insights can be obtained through similar 

studies in different media or context, 

the EPA continues to find that 

independent validation of the study 

findings and conclusions driving the 

EPA’s dose-response assessments would 

provide important information. As 

detailed in Section III.A.1 of this 

preamble, there is scientific support for 

the usefulness of reanalyzing data, and 

the EPA finds this to be especially true 

for data that drive the quantitative 

requirements or analyses of EPA 

significant regulatory actions or 

influential scientific information. 

Implementation of this rule will 

increase transparency and, thus, the 

opportunity for independent subject 

matter experts to validate pivotal 

science, and as the dose-response data 

are better understood the public will, if 

they so choose, be able to more 

effectively comment, engage, and hold 

the EPA accountable during the 

development of future significant 

regulatory actions and influential 

scientific information. 

F. Proposed 40 CFR 30.6 

In the 2018 proposed rule, the EPA 

proposed requirements at 40 CFR 30.6 

specific to dose-response data and 

models. These proposed requirements 

directed the EPA to describe and 

document the assumptions and methods 

it used; to evaluate the appropriateness 

of using default assumptions, including 

assumptions of a linear, no threshold 

dose-response; to explain the scientific 


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basis for each model assumption used; 

and to show the sensitivity of the 

modeled results to alternative 

assumptions. These proposed 

requirements also directed the EPA to 

give explicit consideration to high 

quality studies that explore a broad 

class of parametric dose-response 

models, non-parametric models that 

incorporate fewer assumptions, various 

threshold models, and models that 

investigate factors that might account 

for spatial heterogeneity. 

The EPA received significant 

comment on the 2018 proposed rule 

regarding the proposed 40 CFR 30.6 

requirement that the EPA evaluate the 

appropriateness of using default 

assumptions, ‘‘including assumptions of 

a linear, no threshold dose-response.’’ 

The vast majority of commenters 

asserted that the EPA should not focus 

the requirement to evaluate the 

appropriateness of using default 

assumptions specifically on linear, no 

threshold dose-response. In the 2020 

SNPRM, in response to these comments, 

the EPA proposed a variation of the 

regulatory text which did not include 

the phrase ‘‘including assumptions of a 

linear, no threshold dose-response,’’ 

because this could imply that the 

regulation is specific to those particular 

assumptions. 

The EPA also received significant 

comment on the 2018 proposed rule 

about the proposed 40 CFR 30.6 

requirement to clearly explain the 

scientific basis for each model 

assumption used and to present 

analyses showing the sensitivity of the 

modeled results to alternative 

assumptions. Most commenters 

contended that such a requirement 

would be overly burdensome and 

unnecessary. They recommended that 

the EPA should present sensitivity 

analyses only on the most significant 

assumptions. 

Considering these comments, in the 

2020 SNPRM, the EPA clarified that the 

use of the terms ‘‘model assumptions,’’ 

‘‘assumptions’’ and ‘‘models’’ in the 

proposed regulatory text at 40 CFR 30.6 

apply to the critical assumptions that 

drive the model’s analytic results, not to 

each assumption used in the model. The 

EPA’s proposed revision of the 40 CFR 

30.6 regulatory text reflected this 

clarification. 

After considering comments on both 

the 2018 proposed rule and the 2020 

SNPRM, the EPA has determined that 

this rule should apply to dose-response 

data rather than dose-response data and 

models. Given the specificity of 40 CFR 

30.6 to dose-response data and models, 

and in particular dose-response models, 

the EPA is not finalizing 40 CFR 30.6. 

The EPA is adapting one provision of 40 

CFR 30.6 as a factor in 40 CFR 30.5 in 

determining the consideration to afford 

pivotal science for which the doseresponse data are not available for 

independent validation. Specifically, 

the EPA is finalizing as a factor in 40 

CFR 30.5 the consideration that the EPA 

would give to high quality studies that 

explore a broad class of parametric 

dose-response models, non-parametric 

models that incorporate fewer 

assumptions, various threshold models, 

and models that investigate factors that 

might account for spatial heterogeneity. 

Further, because the EPA is not 

finalizing any part of the provision that 

is specific to assumptions and methods 

associated with dose-response models, 

comments on the proposed 

requirements related to these issues are 

moot. However, while the EPA is not 

finalizing the provisions in 40 CFR 30.6 

that include the term uncertainty, the 

EPA is responding to these comments 

because the term uncertainty is used in 

40 CFR 30.5. The EPA is also 

responding to comments on the 

proposed 40 CFR 30.6 provision 

incorporated as part of 40 CFR 30.5. 

Some commenters contended that the 

EPA’s use of the term ‘‘uncertainty’’ at 

40 CFR 30.6 is vague. A few other 

commenters contended that the EPA 

should include specific requirements in 

40 CFR 30.6 as to the scope of an 

analysis of uncertainty. The EPA 

disagrees with the suggestion that the 

term ‘‘uncertainty’’ is vague or that there 

is significant ambiguity about what 

should be in the scope of a 

characterization of uncertainty. The 

characterization of uncertainty is a key 

factor in the assessments that the EPA 

conducts. It is a component of various 

EPA guidelines (e.g., Framework for 

Human Health Risk Assessment to 

Inform Decision Making, Ref. 36) that 

the EPA relies upon in conducting its 

assessments. The scope of the 

uncertainty analyses that the EPA 

conducts necessarily varies across 

assessments and actions. The intent of 

this regulation is not to force 

uncertainty analyses into a one-size-fitsall approach, as that is not practical, 

good policy, or good science. Thus, a 

regulation of internal procedures, such 

as this one, does not require a regulatory 

definition for a term that is already a 

key component of current EPA practices 

and guidelines and EPA’s assessment 

process. 

Several commenters contended that 

the proposed 40 CFR 30.6 requirement 

that the EPA give explicit consideration 

to high quality studies that explore a 

broad range of parametric dose-response 

or concentration-response models and 

to non-parametric models that 

incorporate fewer assumptions could 

force the EPA into situations in which 

it applies dose-response model(s) that 

are not appropriate for the data being 

assessed. The EPA notes that the final 

regulatory text in 40 CFR 30.5 does not 

require that a specific type of doseresponse model be applied to a 

particular situation. Rather, in 

determining the consideration to afford 

pivotal science for which the doseresponse data are not available for 

independent validation, the EPA will 

evaluate, as appropriate, the extent to 

which the study considered a broad 

range of parametric dose-response or 

concentration-response models, a robust 

set of potential confounding variables, 

nonparametric models that incorporate 

fewer assumptions, various threshold 

models across the dose or exposure 

range, and models that investigate 

factors that might account for spatial 

heterogeneity. 

G. Administrator’s Exemption 

In the 2018 proposed rule, the EPA 

proposed that the Administrator could 

grant case-by-case exemptions to the 

requirements in proposed 40 CFR part 

30 when compliance with those 

requirements is impracticable (proposed 

40 CFR 30.9). In the 2020 SNPRM, the 

EPA modified proposed 40 CFR 30.9 to 

be consistent with other changes 

proposed in the 2020 SNPRM, such that 

the Administrator could grant case-bycase exemptions to the requirements in 

proposed 40 CFR part 30 under specific 

conditions for which compliance with 

the requirements in proposed 40 CFR 

part 30 is impracticable. 

Some commenters supported the 

Administrator’s exemption provision in 

proposed 40 CFR 30.9 while others 

opposed it. Commenters expressing 

support for the exemption provision 

noted that exemptions may be needed to 

account for lawful and reasonable 

restrictions on underlying data and 

models. Commenters expressing 

opposition to the exemption provision 

raised concerns about the Administrator 

granting exemptions from the 

requirements in proposed 40 CFR part 

30. These commenters contended that 

the Administrator may lack the 

scientific expertise to make the 

appropriate exemption decisions and 

that the Administrator, as a political 

appointee, could be biased. Some public 

commenters recommended that the 

exemption process require formal 

consultation with EPA career scientists, 

the EPA’s SAB, or another Agency 

advisory committee. 

The EPA also received comment on 

the following proposed conditions 


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under which the Administrator could 

grant an exception in the 2020 SNPRM: 

Technological barriers render sharing of 

the data or models infeasible; the 

development of the data or model was 

completed or updated before the 

effective date of the final rule; or making 

the data and models available would 

conflict with laws governing privacy, 

confidentiality, CBI, or national 

security. Some commenters supported 

the condition that would allow the 

Administrator to grant an exemption 

based on the age of a study, noting that 

older studies may not have been 

conducted with the intention of 

providing access to underlying data and 

models for independent validation, 

particularly at the stage of data and 

models proposed in the 2020 SNPRM. 

Other commenters opposed this 

condition, contending that exempting 

studies based on the age of the study is 

unnecessary and undermines the goal of 

increasing transparency in the 

development of regulatory decisions. 

Some commenters noted it may be 

prohibitively expensive for researchers 

to make their data and models available. 

The EPA finds that these comments 

have merit, in part. The Agency agrees 

with retaining the Administrator’s 

exemption provision because there are 

conditions under which compliance 

with the requirements in 40 CFR part 30 

might be impracticable. For example, 

the underlying dose-response data for 

some studies, particularly older studies, 

may not be readily publicly available 

because of the technological barriers to 

data sharing (e.g., differences in data 

storage devices or data retention 

practices) that existed when they were 

developed. As a result, the EPA is 

finalizing the Administrator’s 

exemption provision as proposed in the 

2020 SNPRM, with additional 

conditions described here. Due to other 

changes described in this preamble, the 

Administrator’s exemption provision, 

which was previously in 40 CFR 30.9 in 

the 2018 proposed rule and the 2020 

SNPRM, is now 40 CFR 30.7 in the final 

rule. 

The EPA does not agree with the 

comments regarding the role of the 

Administrator in determining whether 

to grant an exemption and finds that the 

Administrator is the appropriate 

decision maker in this context. To 

ensure that the Administrator’s decision 

is appropriately transparent, in the final 

rule the EPA has included a provision 

in 40 CFR 30.7 that requires the Agency 

to document the rationale for any 

exemptions granted by the 

Administrator in the significant 

regulatory action or influential scientific 

information. This documentation would 

typically be provided as part of the 

proposed rulemaking, given that it 

would be part of the decision 

concerning what is the pivotal science 

for the rule. Regardless of what is 

provided in the proposed rule stage of 

the rulemaking, the final rulemaking 

will provide clear documentation. 

Some commenters and the EPA’s SAB 

(Ref. 27) also requested that the EPA 

include criteria that the Administrator 

will consider when determining 

whether to grant exemptions from the 

requirements in 40 CFR part 30. The 

EPA finds that these comments have 

merit and is including additional 

criteria in 30 CFR 30.7 that may be used 

by the Administrator when he or she is 

determining whether greater 

consideration should be afforded to 

pivotal science for which the underlying 

dose-response data are not available in 

a manner sufficient for independent 

validation. As a result, the 

Administrator may also determine that 

greater consideration is warranted when 

a third party has independently 

validated the underlying dose-response 

data through reanalysis or when the 

EPA’s evaluation of the factors in 40 

CFR 30.5(d) indicate that full 

consideration of the pivotal science is 

justified. 

To assist the Administrator in 

determining whether to grant an 

exemption, the EPA program or Region 

responsible for the significant regulatory 

action or influential scientific 

information and public commenters can 

provide input when the Administrator 

is considering an exemption. The EPA 

will document the rationale for the 

Administrator’s exemption in the 

significant regulatory action or 

influential scientific information. The 

EPA is confident that the above criteria 

provide sufficient clarity and 

boundaries for the Administrator to 

consider when granting an exemption 

under 40 CFR 30.7. 

H. Peer Review 

In the 2018 proposed rule and the 

2020 SNPRM, the EPA proposed to 

require independent peer review on 

pivotal regulatory science and pivotal 

science. The EPA also proposed to 

require that the Agency ask peer 

reviewers to opine on the strengths and 

weaknesses of the EPA’s justifications 

for the assumptions used in models. 

Some commenters on the 2018 

proposed rule and 2020 SNPRM 

specifically asked why the EPA would 

need to peer review health and 

scientific studies and scientific 

literature that had already undergone 

independent peer review. They stated 

that the EPA failed to explain why 

existing peer review requirements and 

mechanisms are insufficient. Such 

commenters also noted that in addition 

to being duplicative and unnecessary, 

the proposed requirement would cause 

unnecessary delays in the EPA actions 

and would result in increased costs for 

the Agency. One commenter noted that 

the EPA already has policies in place for 

peer review and referred to the EPA’s 

Peer Review Handbook (Ref. 44). 

Another commenter stated that, while it 

is certainly best practice to consider 

only science that has been 

independently peer reviewed when 

making regulatory decisions, that does 

not necessitate independent peer review 

by the EPA. The commenter noted that 

most scientific bodies and 

publications—including Nature, 

Science, the Bipartisan Policy Center, 

and Proceedings of the National 

Academy of Sciences—employ some of 

the most robust peer review practices 

and that they already apply to the types 

of studies which the proposed rule 

would require the EPA to peer review 

anew. Some commenters also stated that 

the proposed peer review requirements 

specific to assumptions used in models 

suggest that the 40 CFR 30.7 regulatory 

text would require that the EPA conduct 

peer review of the proposed Agency 

action itself, rather than of the science 

underlying that action. One of the 

commenters contended that it is entirely 

unclear how peer review could be 

applied to EPA’s reasoning itself, rather 

than the pivotal science supporting the 

regulatory decision. 

The EPA finds that these comments 

have merit, in part. However, in this 

rule, the EPA is not changing the preexisting requirements of the OMB Final 

Information Quality Bulletin for Peer 

Review (Ref 8). The preamble of the 

Bulletin states that ‘‘the intensity of peer 

review is highly variable across 

journals’’ and ‘‘prior peer review and 

publication is not by itself sufficient 

grounds for determining that no further 

review is necessary’’ (Ref. 8). Peer 

review does not typically include 

reanalysis of the underlying data (i.e., 

the proper stage of data where the data 

that are ready to be analyzed to extract 

relevant information) and, thus, peer 

review is not considered a replacement 

for the data availability requirements of 

this rule. 

The EPA is, therefore, finalizing the 

language at 40 CFR 30.6 (formerly 40 

CFR 30.7 in the 2018 proposed rule and 

the 2020 SNPRM) to clarify that the 

Agency will evaluate whether or not to 

initiate peer review, consistent with the 

OMB Final Information Quality Bulletin 

for Peer Review (Ref. 8) and the EPA’s 

Peer Review Handbook (Ref. 44), of 


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individual studies identified as pivotal 

science if the studies have already 

undergone journal peer review. If the 

Agency conducts peer review on pivotal 

science, the EPA shall ask peer 

reviewers to articulate the strengths and 

weaknesses of the justification for the 

assumptions applied in analyzing doseresponse data and the implications of 

those assumptions for the results. 

I. Changes to 40 CFR 30.4 ‘‘What 

requirements apply to EPA’s use of 

studies in significant regulatory 

actions? ’’ 

In the 2018 proposed rule, the EPA 

proposed to require at 40 CFR 30.4 that 

‘‘EPA shall clearly identify all studies 

(or other regulatory science) relied upon 

when it takes any final action. The EPA 

should make all such studies available 

to the public to the extent practicable.’’ 

Some commenters expressed concern 

that proposed 40 CFR 30.4 would 

permit the Agency to exclude valid 

studies from consideration on the basis 

of the availability of underlying data or 

models. Another commenter noted that 

this section would apply to any final 

agency action, rather than regulatory 

decisions. In response to these 

comments, the EPA notes that this 

section does not require the EPA to 

exclude studies from consideration 

when developing final significant 

regulatory actions either on the basis of 

the availability of underlying data or 

models, or depending on the 

practicability of making these studies 

available to the public. 

The EPA agrees with the commenter 

that the scope of 40 CFR 30.4 should be 

limited to significant regulatory actions, 

which are defined in 40 CFR 30.2 as 

‘‘final regulations determined to be 

‘significant regulatory actions’ by the 

Office of Management and Budget 

pursuant to Executive Order 12866.’’ 

The EPA is finalizing additional 

changes to the title and body of 40 CFR 

30.4 by using terms defined in 40 CFR 

30.2. In the title of 40 CFR 30.4, the EPA 

is replacing ‘‘taking final action’’ with 

‘‘significant regulatory actions’’ to 

improve clarity and specificity, since 

the latter term is defined. In the body of 

40 CFR 30.4, the EPA is replacing ‘‘all 

studies (or other regulatory science) 

relied upon when it takes any final 

agency action’’ with ‘‘science that serves 

as the basis for informing a significant 

regulatory action’’ to improve 

specificity, since the latter language is 

defined; replacing ‘‘should’’ with 

‘‘shall;’’ ‘‘studies’’ with ‘‘science that 

serves as the basis for informing a 

significant regulatory action’’ to 

improve specificity, since the latter term 

is defined; and ‘‘available to the public’’ 

with ‘‘publicly available’’ to improve 

specificity, since the latter term is 

defined. Together, these changes are 

meant to clarify that the requirements of 

40 CFR 30.4 are consistent with the 

EPA’s existing practice of making 

science that serves as the basis for 

informing a significant regulatory action 

available in the public docket as part of 

the rulemaking. 

J. Benefits and Costs 

In the 2018 proposed rule, as part of 

its E.O. 12866 and E.O. 13563 reviews, 

the EPA stated that the benefits of the 

proposal justify the costs. The EPA’s 

rationale was that the rule would 

facilitate expanded data sharing and 

exploration of key data sets, improve the 

ability to independently validate 

analyses underlying significant 

regulatory actions, and would be 

implemented in a cost-effective way. 

The 2020 SNPRM did not provide 

additional characterizations of benefits 

and costs. A number of commenters 

noted that the EPA did not provide an 

economic assessment to support the 

Agency’s benefit-cost claims. 

Commenters also noted that the EPA did 

not characterize costs to the Agency, 

including administrative costs to 

ascertain the public availability of 

underlying data, costs for additional 

analyses required, and costs to ensure 

that PII and CBI are not disclosed. Other 

commenters noted that the EPA had not 

adequately explained the benefits of this 

rule, including enabling increased 

secondary analyses by third party 

researchers. 

The EPA agrees that neither the 2018 

proposed rule nor the 2020 SNPRM 

included a characterization of costs to 

the Agency. The EPA emphasizes that 

this is a rule of internal procedure 

promulgated under the EPA’s 

housekeeping authority. However, the 

EPA has identified some incremental 

costs that the Agency may incur as a 

result of this final rule. As stated in 

Section III.A.2 of this preamble, the EPA 

will continue its current practice of 

conducting extensive review of 

scientific studies during the 

development of significant regulatory 

actions and influential scientific 

information. The additional procedures 

required by this rule apply only to 

pivotal science, which is a subset of the 

total number of studies that the EPA 

would evaluate. Given the costs of the 

current robust process for identifying 

and reviewing scientific studies and 

documentation that are existing Agency 

practice, as well as that the 

determination of dose-response data 

availability is limited to pivotal science 

underlying significant regulatory actions 

and influential scientific information, 

the EPA anticipates that the incremental 

costs of this rule will be small. The 

Agency may also incur other 

administrative costs to perform analyses 

and evaluations to support activities 

such as exemption decisions made by 

the Administrator, and documenting 

these or other decisions made pursuant 

to the requirements of the final rule. 

Again, the Agency anticipates that the 

incremental costs for these activities 

will be small relative to current 

administrative costs for developing 

significant regulatory actions or 

influential scientific information. 

Finally, this final rule does not require 

the EPA to disclose or host data, but to 

determine if dose-response data are 

available and to give greater 

consideration to those studies for which 

such data are available. Hence, this rule 

does not impose costs on the EPA or any 

other party to make data available, 

including costs to ensure that PII and 

CBI are not disclosed. The Agency may 

opt, at its discretion, to incur the costs 

associated with making data available 

when it is in the public interest to do 

so, but that will be decided on a caseby-case basis and is not a requirement 

of the final rule. 

The EPA also agrees that the benefits 

of the rule were not fully characterized 

in the 2018 proposed rule or the 2020 

SNPRM. The EPA emphasizes, however, 

that this is a rule of internal procedure 

promulgated under the EPA’s 

housekeeping authority. As discussed in 

Section III.A.1 of this preamble, the 

main benefits of this rule spring from 

greater transparency in significant 

regulatory actions and influential 

scientific information. By placing 

greater emphasis on the availability of 

dose-response data underlying pivotal 

science, the rule will allow for greater 

scientific scrutiny as EPA decision 

makers are developing significant 

regulatory actions and influential 

scientific information and increases the 

likelihood that any errors will be 

identified and corrected. Greater 

transparency is also inherently valuable 

as a principle of good government and 

provides benefits to the public at large, 

including reducing the risk of errors in 

EPA analyses and in the science such 

analyses rely upon. The ability for 

independent subject matter experts to 

validate pivotal science will facilitate 

more effective comment and 

engagement with the public during 

development of future significant 

regulatory actions and influential 

scientific information. 

Some commenters further argued that 

the EPA failed to account for costs 

external to the EPA as consequence of 


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this rule, including costs to third party 

researchers and their institutions to 

make their raw data available and 

protect PII/CBI through data-masking, 

de-identification, or deposition in 

public data repositories. The EPA 

disagrees with the argument that this 

rule would impose costs on third-party 

researchers. This is a rule of internal 

procedure that does not impose 

requirements on any party other than 

the EPA. This rule imposes no costs on 

researchers or their institutions, and the 

EPA will consider and evaluate all 

relevant and appropriate science in its 

significant regulatory actions and 

influential scientific information. The 

EPA recognizes that researchers and 

other third parties may voluntarily 

consider the EPA’s position on data 

availability, as described in this rule, as 

they make their own decisions about 

how to conduct research and the extent 

to which they make data and models 

available. Researchers may choose to 

make more data and models available, 

but the EPA recognizes that these 

parties will weigh their own benefits 

and costs and make choices that they 

deem appropriate. 

Some commenters argued the 2018 

proposed rule and the 2020 SNPRM 

would impose costs on third parties 

because it would prohibit the EPA from 

using necessary science where the 

underlying data and models are not 

publicly available, which would prevent 

the EPA from meeting its statutory 

obligations and performing its mission 

of protecting human health and the 

environment. Some commenters also 

contended that the proposed rule 

requirements would impose costs to the 

public by delaying EPA regulatory 

actions that protect human health and 

the environment. 

As described earlier, the EPA 

acknowledges and agrees with 

commenters that there may be pivotal 

science where the underlying data are 

not publicly available or available 

through restricted access. The final rule 

is limited to dose-response data and, as 

no studies are categorically excluded 

from consideration, the EPA will 

continue to rely on the full body of the 

highest quality, most relevant studies 

available in determining the potential 

for hazard due to exposure to a 

pollutant, contaminant, or substance. 

Consistent with the requirements of this 

rule, the EPA will identify a subset of 

those studies based on the exposure 

situation being addressed, the quality of 

the studies, the reporting adequacy, and 

the relevance of the endpoints that 

would inform a dose-response 

assessment, and will give greater 

consideration to pivotal science for 

which the underlying dose-response 

data are available. The EPA disagrees 

with commenters that the requirements 

of this rule will result in any meaningful 

delay in promulgating regulations. 

While this final rule requires the 

Agency to evaluate the availability of 

dose-response data for pivotal science, 

the incremental burden to the Agency to 

carry out these requirements is expected 

to be small given (1) the extensive 

scientific review the EPA already 

conducts regularly and (2) that the 

requirement is limited to pivotal science 

(i.e., typically a small, though highly 

important, subset of the studies the EPA 

would review). Further, with this final 

rule, the EPA is maintaining language in 

40 CFR 30.3 stating that the statutes that 

the EPA administers, or their 

implementing regulations, will control 

in the event of any conflicts with the 

requirements of this rule. The Agency 

will continue to comply with and abide 

by the requirements in those statutes 

and implementing regulations, 

including regulatory deadlines. 

K. Proposed 40 CFR 30.8 ‘‘How is EPA 

to account for cost under this subpart?’’ 

In 2018, the EPA proposed in 40 CFR 

30.8 that ‘‘EPA shall implement the 

provisions of this subpart in a manner 

that minimizes costs.’’ A number of 

commenters argued that this statement 

was vague and that the 2018 proposed 

rule neither explained what costs this 

rule would incur, nor how they would 

be minimized. One commenter further 

raised concern that, in order to 

minimize costs, proposed 40 CFR 30.8 

may require the EPA to exclude valid 

data from consideration rather than take 

potentially expensive steps to protect 

CBI, proprietary data, and PII. Still other 

commenters interpreted proposed 40 

CFR 30.8 as requiring the EPA to base 

its final significant regulatory actions 

and influential scientific information on 

cost. Commenters expressed concern 

that this would be at the exclusion of 

considerations such as the best available 

science and public health. A commenter 

further argued that the EPA does not 

have the statutory authority to base its 

assessment of science on cost without 

consideration of public health and 

environmental costs and benefits and 

privacy-related costs and benefits, and 

that doing so would be irrational and 

arbitrary. 

As explained in Section III.J of this 

preamble, this rule of internal procedure 

is anticipated to incur small incremental 

costs related to the additional review of 

data availability, as compared to the 

Agency’s existing costs for extensive 

review and documentation as part of the 

development of significant regulatory 

actions and influential scientific 

information. In consideration of the 

public comments, however, the EPA is 

not finalizing proposed 40 CFR 30.8 

‘‘How is EPA to account for cost under 

this subpart?’’ This rule is not intended 

to require the EPA to exclude valid data 

from consideration on the basis of cost, 

nor interpret the EPA’s statutory 

authority to consider costs in significant 

regulatory actions or influential 

scientific information. Given the EPA’s 

existing commitment to fulfill its duties 

in a cost-effective manner, the EPA has 

determined not to finalize proposed 40 

CFR 30.8. 

IV. References 

The following is a listing of the 

documents that are specifically 

referenced in this notice. The docket 

includes these documents and other 

information considered by EPA, 

including documents referenced within 

the documents that are included in the 

docket, even if the referenced document 

is not physically located in the docket. 

For assistance in locating these other 

documents, please consult the person 

listed under FOR FURTHER INFORMATION

CONTACT. 

1. E.O. 13777, Enforcing the Regulatory 

Reform Agenda, 82 FR 12285 (March 1, 

2017), available at https://

www.federalregister.gov/documents/ 

2017/03/01/2017-04107/enforcing-theregulatory-reform-agenda. 

2. E.O. 13783, Promoting Energy 

Independence and Economic Growth, 82 

FR 16093 (March 31, 2017), available at 

https://www.federalregister.gov/ 

documents/2017/03/31/2017-06576/ 

promoting-energy-independence-andeconomic-growth. 

3. Office of Mgmt. & Budget, Exec. Office of 

the President, Guidelines for Ensuring 

and Maximizing the Quality, Objectivity, 

Utility, and Integrity of Information 

Disseminated by Federal Agencies, 67 FR 

8451 (February 22, 2002), available at 

https://www.federalregister.gov/ 

documents/2002/02/22/R2-59/ 

guidelines-for-ensuring-and-maximizingthe-quality-objectivity-utility-andintegrity-of-information. 

4. Office of Mgmt. & Budget, Exec. Office of 

the President, Open Data Policy— 

Managing Information as an Asset, OMB 

M–13–13 (May 9, 2013), available at 

https://www.whitehouse.gov/sites/ 

whitehouse.gov/files/omb/memoranda/ 

2013/m-13-13.pdf. 

5. U.S. EPA. Strengthening Transparency in 

Regulatory Science; Proposed Rule, 83 

FR 18768 (April 30, 2018) (FRL–9977– 

40), available at https://

www.federalregister.gov/documents/ 

2018/04/30/2018-09078/strengtheningtransparency-in-regulatory-science. 

6. U.S. EPA. Strengthening Transparency in 

Regulatory Science; Proposed Rule, 83 

FR 24255 (May 25, 2018) (FRL–9978–31), 


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2018-11316/strengthening-transparencyin-regulatory-science-extension-ofcomment-period-and-notice-of-public. 

7. U.S. EPA. Strengthening Transparency in 

Regulatory Science; Supplemental 

Notice of Proposed Rulemaking, 85 FR 

15396 (March 18, 2020) (FRL–10004–72– 

ORD), available at https://www.federal

register.gov/documents/2020/03/18/ 

2020-05012/strengthening-transparencyin-regulatory-science. 

8. Office of Mgmt. & Budget, Exec. Office of 

the President, Final Information Quality 

Bulletin for Peer Review, 70 FR 2664 

(January 14, 2005), available at https://

www.federalregister.gov/documents/ 

2005/01/14/05-769/final-informationquality-bulletin-for-peer-review. 

9. U.S. EPA. (2016). Plan to Increase Access 

to Results of EPA-Funded Scientific 

Research. (EPA/601–R–16–005). 

Washington, DC: U.S. Environmental 

Protection Agency. Available at https:// 

www.epa.gov/sites/production/files/ 

2016-12/documents/epascientific

researchtransperancyplan.pdf. 

10. U.S. EPA. (2018). Open Government Plan 

5.0. Washington, DC: U.S. Environmental 

Protection Agency. Available at https:// 

www.epa.gov/sites/production/files/ 

2018-10/documents/epaopengovplan

version5_0final.pdf. 

11. Office of Mgmt. & Budget, Exec. Office of 

the President, OMB M–10–06, Open 

Government Directive (December 8, 

2009), available at https://

www.whitehouse.gov/sites/ 

whitehouse.gov/files/omb/memoranda/ 

2010/m10-06.pdf. 

12. Office of Science and Technology Policy. 

(2013). Memorandum for the Heads of 

Executive Departments and Agencies: 

Increasing Access to the Results of 

Federally Funded Scientific Research. 

Available at https://www.epa.gov/sites/ 

production/files/2015-01/documents/ 

ostp_memo_increasing_public_

access.pdf. 

13. Office of Mgmt. & Budget, Exec. Office of 

the President, OMB M–19–23, Phase 1 

Implementation of the Foundations for 

Evidence-Based Policymaking Act of 

2018—Learning Agendas, Personnel, and 

Planning Guidance (July 10, 2019), 

available at https://www.whitehouse.

gov/wp-content/uploads/2019/07/M-19- 

23.pdf. 

14. Office of Mgmt. & Budget, Exec. Office of 

the President, OMB M–20–12, Phase 4 

Implementation of the Foundations for 

Evidence-Based Policymaking Act of 

2018—Program Evaluation Standards 

and Practices (March 10, 2020), available 

at https://www.whitehouse.gov/wpcontent/uploads/2020/03/M-20-12.pdf. 

15. McNutt, M. (2016). Taking up TOP. 

Science 352, 1147. Available at https:// 

doi.org/10.1126/science.aag2359. 

16. NAS (National Academies of Sciences, 

Engineering, and Medicine). (2019). 

Reproducibility and replicability in 

science. Washington, DC: The National 

Academies Press. Available at https://

www.nationalacademies.org/our-work/ 

reproducibility-and-replicability-inscience. 

17. Nosek, B.A. et al. (2015). Promoting an 

open research culture. Science 348, 

1422–1425. Available at https://doi.org/ 

10.1126/science.aab2374. 

18. Office of Mgmt. & Budget, Exec. Office of 

the President, OMB M–19–15, Improving 

Implementation of the Information 

Quality Act (April 24, 2019), available at 

https://www.whitehouse.gov/wp-content/ 

uploads/2019/04/M-19-15.pdf. 

19. Calabrese, E.J. (2019). EPA transparency 

proposal: Testimony of Edward J. 

Calabrese, Ph.D., October 3, 2018. J Cell 

Commun Signal. 13(1): 145–147. https:// 

doi.org/10.1007%2Fs12079-018-0497-8. 

20. Perrone, J. (2014). Secrets are no fun. The 

Hill. Available at https://thehill.com/ 

blogs/congress-blog/energy-environment/ 

224583-secrets-are-no-fun. 

21. U.S. Congress. (2010). Current Science on 

Public Exposures to Toxic Chemicals: 

Hearing before the Subcommittee on 

Superfund, Toxics and Environmental 

Health of the Committee on Environment 

and Public Works, 111th Congress. 

Available at https://www.govinfo.gov/ 

content/pkg/CHRG-111shrg21160/html/ 

CHRG-111shrg21160.htm. 

22. U.S. Congress. (2010). Letter to EPA 

Administrator Jackson. Available at 

https://assets.documentcloud.org/ 

documents/1202768/letter-fromcongress-to-lisa-jackson-on-arsenic.pdf. 

23. U.S. Congress. (2011). EPA’s IRIS 

Program: Evaluating the Science and 

Process Behind Chemical Risk 

Assessment: Hearing before the 

Subcomm. on Oversight & Investigations 

of the H. Comm. on Science, Space, & 

Technology, 112th Cong. Available at 

https://www.govinfo.gov/content/pkg/ 

CHRG-112hhrg67255/html/CHRG112hhrg67255.htm. 

24. McNutt, M. (2014). Journals unite for 

reproducibility. Science 346(6210): 679. 

Available at https://doi.org/10.1126/ 

science.aaa1724. 

25. Munafo`, M.R. et al. (2017). A manifesto 

for reproducible science. Nature Human 

Behaviour 1(0021). Available at https:// 

doi.org/10.1038/s41562-016-0021. 

26. NAS (National Academies of Sciences, 

Engineering, and Medicine). (2016). 

Principles and obstacles for sharing data 

from environmental health research: 

Workshop summary. Washington, DC: 

The National Academies Press. Available 

at https://doi.org/10.17226/21703. 

27. U.S. EPA’s Science Advisory Board. 

(2020). Science Advisory Board 

Consideration of the Scientific and 

Technical Basis of EPA’s Proposed Rule 

Titled ‘‘Strengthening Transparency in 

Regulatory Science.’’ EPA–SAB–20–005. 

Available at https://yosemite.epa.gov/ 

sab/sabproduct.nsf/LookupWebProjects

CurrentBOARD/2DB3986BB8390

B308525855800630FCB/$File/EPA-SAB20-005.pdf. 

28. Alsheikh-Ali, A.A., Qureshi, W., AlMallah, M.H., and Ioannidis, J.P. (2011). 

Public availability of published research 

data in high-impact journals. PloS ONE 

6, e24357. Available at https://doi.org/ 

10.1371/journal.pone.0024357. 

29. Iqbal, S.A., Wallach, J.D., Khoury, M.J., 

Schully, S.D., and Ioannidis, J.P. (2016). 

Reproducible research practices and 

transparency across the biomedical 

literature. PLoS Biol. 14, e1002333. 

Available at https://doi.org/10.1371/ 

journal.pbio.1002333. 

30. Peterson, E.D. and Rockhold, F.W. (2018). 

Finding means to fulfill the societal and 

academic imperative for open data 

access and sharing. JAMA Cardiology. 

Available at https://doi.org/10.1001/ 

jamacardio.2018.0129. 

31. Wicherts, J.M., Borsboom, D., Kats, J. and 

Molenaar, D. (2006). The poor 

availability of psychological research 

data for reanalysis. Am. Psychol. 61, 

726–728. Available at https://doi.org/ 

10.1037/0003-066x.61.7.726. 

32. Christensen, G., Dafoe, A., Miguel, E., 

Moore, D.A., and Rose, A.K. (2019). A 

study of the impact of data sharing on 

article citations using journal policies as 

a natural experiment. PLoS ONE 14(12): 

e0225883. Available at https://doi.org/ 

10.1371/journal.pone.0225883. 

33. Vasilevsky, N.A. et al. (2017). 

Reproducible and reusable research: Are 

journal data sharing policies meeting the 

mark? PeerJ 5:e3208. Available at https:// 

doi.org/10.7717/peerj.3208. 

34. Stodden V., Seiler J., and Ma Z. (2018). 

An empirical analysis of journal policy 

effectiveness for computational 

reproducibility. PNAS 115(11): 2584– 

2589. Available at https://doi.org/ 

10.1073/pnas.1708290115. 

35. U.S. EPA. (2002). Guidelines for Ensuring 

and Maximizing the Quality, Objectivity, 

Utility, and Integrity of Information 

Disseminated by the Environmental 

Protection Agency. (EPA/260R–02–008). 

Washington, DC: U.S. Environmental 

Protection Agency. Available at https:// 

www.epa.gov/sites/production/files/ 

2020-02/documents/epa-info-qualityguidelines_pdf_version.pdf. 

36. U.S. EPA. (2014). Framework for Human 

Health Risk Assessment to Inform 

Decision Making. (EPA/100/R–14/001). 

Washington, DC: U.S. Environmental 

Protection Agency, Office of the Science 

Advisor, Risk Assessment Forum. 

Available at https://www.epa.gov/sites/ 

production/files/2014-12/documents/ 

hhra-framework-final-2014.pdf. 

37. U.S. EPA. (2003). A Summary of General 

Assessment Factors for Evaluating the 

Quality of Scientific and Technical 

Information. (EPA 100/B–03/001). 

Washington, DC: U.S. Environmental 

Protection Agency. Available at https:// 

www.epa.gov/sites/production/files/ 

2015-01/documents/assess2.pdf. 

38. Lewandowsky, S. and Oberauer, K. 

(2020). Low replicability can support 

robust and efficient science. Nat 

Commun 11, 358. https://doi.org/ 

10.1038/s41467-019-14203-0. 

39. Mueller-Langer, F., Fecher, B., Harhoff, 

D., and Wagner, G.G. (2019). Replication 

studies in economics—How many and 

which papers are chosen for replication, 

and why? Research Policy 48: 62–83. 

Available at https://doi.org/10.1016/ 

j.respol.2018.07.019. 


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40. Field, S.M. et al. (2019). When and Why 

to Replicate: As Easy as 1, 2, 3? Collabra: 

Psychology, 5(1): 46. Available at https:// 

doi.org/10.1525/collabra.218. 

41. Hardwicke, T., Tessler, M., Peloquin, B., 

and Frank, M. (2018). A Bayesian 

decision-making framework for 

replication. Behavioral and Brain 

Sciences, 41, E132. Available at https:// 

doi.org/10.1017/s0140525x18000675. 

42. U.S. EPA. (2020). Freedom of Information 

Act Annual Report Fiscal Year 2019. 

Washington, DC: U.S. Environmental 

Protection Agency. Available at https:// 

www.epa.gov/foia/epa-foia-annualreport-2019. 

43. FDA (Food and Drug Administration). 

(2011). Advancing Regulatory Science at 

FDA. Available at https://www.fda.gov/ 

science-research/advancing-regulatoryscience/strategic-plan-regulatoryscience. 

44. U.S. EPA. (2015). Peer Review Handbook, 

4th Edition. (EPA/100/B–15/001). 

Washington, DC: U.S. Environmental 

Protection Agency. Available at https:// 

www.epa.gov/sites/production/files/ 

2020-08/documents/epa_peer_review_

handbook_4th_edition.pdf. 

V. Statutory and Executive Orders 

Reviews 

Additional information about these 

statutes and Executive orders can be 

found at https://www.epa.gov/lawsregulations/laws-and-executive-orders. 

A. Executive Order 12866: Regulatory 

Planning and Review and Executive 

Order 13563: Improving Regulation and 

Regulatory Review 

This action is a significant regulatory 

action that was submitted to the Office 

of Management and Budget (OMB) for 

review. Any changes made in response 

to OMB recommendations have been 

documented in the docket. The EPA 

does not anticipate that this rulemaking 

will have an economic impact on 

regulated entities. 

B. Executive Order 13771: Reducing 

Regulations and Controlling Regulatory 

Costs 

This action is not subject to Executive 

Order 13771 because this final rule is a 

rulemaking of agency organization, 

procedure, or practice. 

C. Paperwork Reduction Act (PRA) 

This action does not contain any 

information collection activities and 

therefore does not impose an 

information collection burden under the 

PRA. 

D. Regulatory Flexibility Act (RFA) 

I certify that this action will not have 

a significant economic impact on a 

substantial number of small entities 

under the RFA. This action will not 

impose any requirements on small 

entities. This action does not regulate 

any entity outside the Federal 

Government. 

E. Unfunded Mandates Reform Act 

(UMRA) 

This action does not contain any 

unfunded mandate as described in 

UMRA, 2 U.S.C. 1531–1538, and does 

not significantly or uniquely affect small 

governments. The action imposes no 

enforceable duty on any state, local or 

tribal governments or the private sector. 

F. Executive Order 13132: Federalism 

This action does not have federalism 

implications. 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. 

G. Executive Order 13175: Consultation 

and Coordination With Indian Tribal 

Governments 

This action does not have tribal 

implications as specified in Executive 

Order 13175. Thus, Executive Order 

13175 does not apply to this action. 

H. Executive Order 13045: Protection of 

Children From Environmental Health 

Risks and Safety Risks 

The EPA interprets Executive Order 

13045 as applying only to those 

regulatory actions that concern 

environmental health or safety risks that 

the EPA has reason to believe may 

disproportionately affect children, per 

the definition of ‘‘covered regulatory 

action’’ in section 2–202 of the 

Executive order. This action is not 

subject to Executive Order 13045 

because it does not concern an 

environmental health risk or safety risk. 

I. Executive Order 13211: Actions 

Concerning Regulations That 

Significantly Affect Energy Supply, 

Distribution or Use 

This action is not a ‘‘significant 

energy action’’ within the meaning of 

Executive Order 13211. It is not likely 

to have a significant adverse effect on 

the supply, distribution or use of 

energy, and it has not otherwise been 

designated as a significant energy action 

by the Administrator of the Office of 

Information and Regulatory Affairs 

(OIRA). 

J. National Technology Transfer and 

Advancement Act (NTTAA) 

This rulemaking does not involve 

technical standards. 

K. Executive Order 12898: Federal 

Actions To Address Environmental 

Justice in Minority Populations and 

Low-Income Populations 

The EPA believes that this action is 

not subject to Executive Order 12898 (59 

FR 7629, February 16, 1994) because it 

does not establish an environmental 

health or safety standard. 

L. Congressional Review Act (CRA) 

This rule is exempt from the CRA 

because it is a rule of agency 

organization, procedure or practice that 

does not substantially affect the rights or 

obligations of non-agency parties. 

List of Subjects in 40 CFR Part 30 

Environmental protection, 

Administrative practice and procedure, 

Reporting and recordkeeping 

requirements. 

Andrew Wheeler, 

Administrator. 

■ For the reasons set forth in the 

preamble, the EPA is adding 40 CFR 

part 30 to read as follows: 

PART 30—TRANSPARENCY IN 

SIGNIFICANT REGULATORY ACTIONS 

AND INFLUENTIAL SCIENTIFIC 

INFORMATION 

Sec. 

30.1 What is the purpose of this part? 

30.2 What definitions apply to this part? 

30.3 How do the provisions of this part 

apply? 

30.4 What requirements apply to the EPA’s 

use of studies in significant regulatory 

actions? 

30.5 What requirements apply to the EPA’s 

use of dose-response data underlying 

pivotal science? 

30.6 What role does independent peer 

review have in this part? 

30.7 May the EPA Administrator grant 

exemptions to this part? 

Authority: 5 U.S.C. App.; Pub. L. 98–80, 84 

Stat. 2086. 

§ 30.1 What is the purpose of this part? 

This part directs the EPA to give 

greater consideration to pivotal science 

when the underlying dose-response data 

are available in a manner sufficient for 

independent validation. 

§ 30.2 What definitions apply to this part? 

For the purposes of this part: 

Data means the set of recorded factual 

material commonly accepted in the 

scientific community as necessary to 

validate research findings in which 

obvious errors, such as keystroke or 

coding errors, have been removed and 

that is capable of being analyzed by 

either the original researcher or an 

independent party. 


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Dose-response data means the data 

used to characterize the quantitative 

relationship between the amount of 

dose or exposure to a pollutant, 

contaminant, or substance and an effect. 

Independent validation means the 

reanalysis of study dose-response data 

by subject matter experts who have not 

contributed to the development of the 

study to evaluate whether results 

similar to those reported in the study 

are produced. 

Influential scientific information 

means scientific information the Agency 

reasonably can determine will have or 

does have a clear and substantial impact 

on important public policies or private 

sector decisions. 

Pivotal science means the specific 

dose-response studies or analyses that 

drive the requirements or quantitative 

analyses of EPA significant regulatory 

actions or influential scientific 

information. 

Publicly available means lawfully 

available to the general public from 

Federal, state, or local government 

records; the internet; widely distributed 

media; or disclosures to the general 

public that are required to be made by 

Federal, state, or local law. The public 

must be able to access the information 

on the date of publication of the 

proposed rule (or, as appropriate, a 

supplemental notice of proposed 

rulemaking, or notice of availability) for 

the significant regulatory action or on 

the date of dissemination of the draft 

influential scientific information for 

public review and comment. 

Reanalyze means to analyze exactly 

the same dose-response data to 

determine whether a similar result 

emerges from the analysis by using the 

same methods, statistical software, 

models, or statistical methodologies that 

were used to analyze the dose-response 

data, as well as to assess potential 

analytical errors and variability in the 

underlying assumptions of the original 

analysis. 

Science that serves as the basis for 

informing a significant regulatory action 

means studies, analyses, models, and 

assessments of a body of evidence that 

provide the basis for EPA significant 

regulatory actions. 

Significant regulatory actions means 

final regulations determined to be 

‘‘significant regulatory actions’’ by the 

Office of Management and Budget 

pursuant to Executive Order 12866. 

§ 30.3 How do the provisions of this part 

apply? 

(a) The provisions of this part apply 

to science that serves as the basis for 

informing a significant regulatory action 

or influential scientific information, as 

well as to dose-response data 

underlying pivotal science, regardless of 

the source of funding or identity of the 

party conducting the science. The 

provisions of this part apply to 

significant regulatory actions for which 

a proposed rule was published in the 

Federal Register after January 6, 2021 

and influential scientific information 

submitted for peer review after January 

6, 2021. 

(b) The provisions of this part do not 

apply to physical objects (like laboratory 

samples), drafts, and preliminary 

analyses, and influential scientific 

information or pivotal science that meet 

one or more of the exemptions 

identified in Section IX of the OMB 

Final Information Quality Bulletin for 

Peer Review. In the event the 

procedures outlined in this part conflict 

with statutes the EPA administers, or 

their implementing regulations, the 

statutes and regulations will control. 

Except where explicitly stated 

otherwise, the provisions of this part do 

not apply to any other type of Agency 

action, including individual party 

adjudications, enforcement activities, 

site-specific actions, or permit 

proceedings. 

§ 30.4 What requirements apply to the 

EPA’s use of studies in significant 

regulatory actions? 

The EPA shall clearly identify the 

science that serves as the basis for 

informing a significant regulatory 

action. The EPA shall make all such 

science that serves as the basis for 

informing a significant regulatory action 

publicly available to the extent 

permitted by law. 

§ 30.5 What requirements apply to the 

EPA’s use of dose-response data 

underlying pivotal science? 

(a) When promulgating a significant 

regulatory action or developing 

influential scientific information that 

relies on dose-response data, the Agency 

shall follow best practices to evaluate 

potential links between exposure to a 

pollutant, contaminant, or substance 

and the effect and the nature of the 

dose-response relationship. 

(b) The EPA will use the following 

factors to assess the quality of studies 

identified in the systematic review: 

soundness, applicability and utility, 

clarity and completeness, uncertainty 

and variability, and evaluation and 

review. The EPA will rely on the highest 

quality, most relevant studies in 

determining the potential for hazard due 

to exposure to a pollutant, contaminant, 

or substance. Where there is convincing 

and well-substantiated evidence of a 

relationship between exposure and 

effect, the EPA will identify those 

studies based on the exposure situation 

being addressed, the quality of the 

studies, the reporting adequacy, and the 

relevance of the endpoints that would 

inform a dose-response assessment for 

those effect endpoints. From the subset 

in the preceding sentence, the specific 

dose-response studies or analyses that 

drive the requirements, quantitative 

analyses, or both of an EPA significant 

regulatory action or influential scientific 

information will be identified as pivotal 

science. 

(c) The EPA shall give greater 

consideration to pivotal science where 

the underlying dose-response data are 

publicly available in a manner sufficient 

for independent validation. The Agency 

shall also give greater consideration to 

pivotal science based on dose-response 

data that include confidential business 

information, proprietary information or 

personally identifiable information if 

these data are available through 

restricted access in a manner sufficient 

for independent validation. For pivotal 

science where there is no access to doseresponse data, or access is limited, the 

Agency may still consider these studies 

but will give them lesser consideration 

unless the Administrator grants an 

exemption under § 30.7. The Agency 

will identify the pivotal science that 

was given lesser consideration and 

provide a short description of why 

lesser consideration was given. 

(d) In determining the degree of 

consideration to afford pivotal science 

for which the dose-response data are not 

available for independent validation, 

the EPA shall consider the following 

factors and any other relevant factors, as 

applicable: 

(1) The quality of the study relative to 

other studies for which the doseresponse data are available; 

(2) The extent to which there are other 

studies for which the dose-response 

data are available; 

(3) The sensitivity of the conclusions 

in the significant regulatory action or 

influential scientific information based 

on the use of the study; 

(4) The extent to which the study is 

fit for the purpose or intended use 

relative to other pivotal science for 

which the dose-response data are 

available; 

(5) The use of exposures or doses in 

a range and duration that is relevant for 

the intended use and that minimizes the 

need for extrapolations; 

(6) The extent to which the study is 

supported by other scientific evidence; 

(7) The extent to which the study 

accounted for unique scientific 

considerations; 


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(8) The extent to which the study 

minimizes the use of defaults and 

assumptions, uses appropriate and 

strong statistical methods, and includes 

a robust representation of uncertainty 

and confidence intervals; and 

(9) The study’s consideration of a 

broad range of parametric dose-response 

or concentration-response models, a 

robust set of potential confounding 

variables, nonparametric models that 

incorporate fewer assumptions, various 

threshold models across the dose or 

exposure range, and models that 

investigate factors that might account 

for spatial heterogeneity. 

(e) The EPA shall also describe 

critical assumptions and methods used 

in its dose-response assessment and 

shall characterize the variability and 

uncertainty of the assessment. The EPA 

shall evaluate the appropriateness of 

using default assumptions on a case-bycase basis. The EPA shall clearly 

explain the scientific basis for critical 

assumptions used in the dose-response 

assessment that the EPA relied on for 

the significant regulatory action or 

influential scientific information. 

(f) Where the Agency is making doseresponse data publicly available, it shall 

do so in a fashion that is consistent with 

law, protects privacy, confidentiality, 

confidential business information, and 

is sensitive to national security. Doseresponse data is considered ‘‘publicly 

available in a manner sufficient for 

independent validation’’ when it 

includes the information necessary for 

the public to understand, assess, and 

reanalyze findings and may include, for 

example: 

(1) Data (data would be made 

available subject to access and use 

restrictions); 

(2) Associated protocols necessary to 

understand, assess, and extend 

conclusions; 

(3) Computer codes and models 

involved in the creation and analysis of 

such information; 

(4) Recorded factual materials; and 

(5) Detailed descriptions of how to 

access and use such information. 

(g) The provisions of this section 

apply to dose-response data underlying 

studies that are pivotal science, 

regardless of who funded or conducted 

the studies. The Agency shall make all 

reasonable efforts to explore 

methodologies, technologies, and 

institutional arrangements for making 

such data available before it concludes 

that doing so in a manner consistent 

with law and protection of privacy, 

confidentiality, national security is not 

possible. 

§ 30.6 What role does independent peer 

review have in this part? 

The EPA shall conduct independent 

peer review consistent with the 

requirements of the OMB Final 

Information Quality Bulletin for Peer 

Review and the exemptions described 

therein. The EPA will evaluate whether 

or not to conduct additional peer review 

of individual studies identified as 

pivotal science if the studies have 

already undergone journal peer review. 

Because transparency in pivotal science 

includes addressing issues associated 

with assumptions used in analyzing 

dose-response data, the EPA shall ask 

peer reviewers to articulate the strengths 

and weaknesses of the justification for 

the assumptions applied and the 

implications of those assumptions for 

the results. 

§ 30.7 May the EPA Administrator grant 

exemptions to this part? 

(a) The Administrator may grant an 

exemption to this part for a study on a 

case-by-case basis if he or she 

determines that greater consideration is 

warranted because: 

(1) Technological or other barriers 

render sharing of the dose-response data 

infeasible; 

(2) The development of the doseresponse data was completed or 

updated before January 6, 2021; 

(3) Making the dose-response data 

available would conflict with laws and 

regulations governing privacy, 

confidentiality, confidential business 

information, or national security; 

(4) A third-party has conducted 

independent validation of the study’s 

underlying dose-response data through 

reanalysis; or 

(5) The factors used in determining 

the consideration to afford to the pivotal 

science indicate full consideration is 

justified. 

(b) When making a decision to grant 

an exemption, the Administrator may 

consider input from EPA staff and 

public commenters. The EPA shall 

document the rationale for exemptions 

granted by the Administrator in the 

significant regulatory action or 

influential scientific information. 

[FR Doc. 2020–29179 Filed 1–5–21; 8:45 am] 

BILLING CODE 6560–50–P 

AGENCY FOR INTERNATIONAL 

DEVELOPMENT 

48 CFR Chapter 7 

RIN 0412–AA86 

Leave and Holidays for U.S. Personal 

Services Contractors, including Family 

and Medical Leave; Corrections 

AGENCY: Agency for International 

Development. 

ACTION: Correcting amendments; final 

rule. 

SUMMARY: On October 16, 2020, the U.S. 

Agency for International Development 

(USAID) issued a final rule revising 

provisions of the AID Acquisition 

Regulation (AIDAR) that pertain to the 

General Provision contract clause 5, 

entitled ‘‘Leave and Holidays’’ for U.S. 

personal services contractors (USPSCs.) 

This document corrects typographical 

errors in the final rule by revising the 

text of clause 5, adding the effective 

dates in the titles of clauses 6 and 16, 

and revising the authority citation. 

DATES: Effective January 6, 2021. 

FOR FURTHER INFORMATION CONTACT: 

Richard E. Spencer, Procurement 

Analyst, by phone at 202–916–2629, or 

email at rspencer@usaid.gov. All 

communications regarding this rule 

must cite AIDAR RIN No. 0412–AA86. 

SUPPLEMENTARY INFORMATION: USAID is 

correcting errors in the final rule 

entitled ‘‘Leave and Holidays for U.S. 

Personal Services Contractors, including 

Family and Medical Leave,’’ under 

AIDAR 48 CFR chapter 7, appendix D, 

which was published in the Federal 

Register on October 16, 2020 (85 FR 

65734). This document corrects the 

following typographical errors in 

AIDAR appendix D. In section 12 clause 

5, the title is revised to remove italics, 

and the last sentence of paragraph (a)(3) 

is revised because the final rule 

mistakenly included the word ‘‘either’’ 

twice, making the application of the 

sub-paragraphs (i) and (ii) illogical and 

impossible to apply. This document 

corrects the construction of this 

sentence in paragraph (a)(3) to ensure 

only one of the two sub-paragraphs (i) 

or (ii) may apply, and by using the 

matching terminology for ‘‘exceptional 

circumstances’’ that appears earlier in 

the paragraph. In the titles for clauses 6, 

‘‘Differential and Allowances,’’ and 16, 

‘‘Termination’’, the effective dates 

missing from the final rule are inserted 

for each clause. Lastly, the final rule 

mistakenly included an instruction to 

add a parenthetical authority citation at 

the end, unnecessarily creating a double 

citation. This document instead revises 


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