Federal Register / Vol. 87, No. 33 / Thursday, February 17, 2022 / Rules and Regulations 8953 

1 62 FR 27968 (May 22, 1997). 

this preamble. EPA has made, and will 

continue to make, these materials 

generally available through https://

www.regulations.gov and at the EPA 

Region 10 Office (please contact the 

person identified in the FOR FURTHER

INFORMATION CONTACT section of this 

preamble for more information). 

Therefore, these materials have been 

approved by EPA for removal from the 

Alaska SIP, have been removed from 

incorporation by reference by EPA into 

that plan, are no longer federally 

enforceable under sections 110 and 113 

of the CAA as of the effective date of the 

final rule of the EPA’s approval, and 

incorporation by reference will be 

removed by the Director of the Federal 

Register in the next update to the SIP 

compilation.1

IV. Statutory and Executive Order 

Review 

Under the CAA, the Administrator is 

required to approve a SIP submission 

that complies with the provisions of the 

CAA and applicable Federal regulations. 

42 U.S.C. 7410(k); 40 CFR 52.02(a). 

Thus, in reviewing SIP submissions, the 

EPA’s role is to approve state choices, 

provided that they meet the criteria of 

the CAA. Accordingly, this action 

merely approves state law as meeting 

Federal requirements and does not 

impose additional requirements beyond 

those imposed by state law. For that 

reason, this action: 

• Is not a ‘‘significant regulatory 

action’’ subject to review by the Office 

of Management and Budget under 

Executive Orders 12866 (58 FR 51735, 

October 4, 1993) and 13563 (76 FR 3821, 

January 21, 2011); 

• Does not impose an information 

collection burden under the provisions 

of the Paperwork Reduction Act (44 

U.S.C. 3501 et seq.); 

• Is certified as not having a 

significant economic impact on a 

substantial number of small entities 

under the Regulatory Flexibility Act (5 

U.S.C. 601 et seq.); 

• Does not contain any unfunded 

mandate or significantly or uniquely 

affect small governments, as described 

in the Unfunded Mandates Reform Act 

of 1995 (Pub. L. 104–4); 

• Does not have federalism 

implications as specified in Executive 

Order 13132 (64 FR 43255, August 10, 

1999); 

• Is not an economically significant 

regulatory action based on health or 

safety risks subject to Executive Order 

13045 (62 FR 19885, April 23, 1997); 

• Is not a significant regulatory action 

subject to Executive Order 13211 (66 FR 

28355, May 22, 2001); 

• Is not subject to requirements of 

section 12(d) of the National 

Technology Transfer and Advancement 

Act of 1995 (15 U.S.C. 272 note) because 

application of those requirements would 

be inconsistent with the Clean Air Act; 

and 

• Does not provide EPA with the 

discretionary authority to address, as 

appropriate, disproportionate human 

health or environmental effects, using 

practicable and legally permissible 

methods, under Executive Order 12898 

(59 FR 7629, February 16, 1994). 

The Alaska SIP does not apply on any 

Indian reservation land in or in any 

other area where EPA or Indian tribe has 

demonstrated that a tribe has 

jurisdiction. In those areas of Indian 

country, this rulemaking does not have 

tribal implications as specified by 

Executive Order 13175 (65 FR 67249, 

November 9, 2000), nor will it impose 

substantial direct costs on tribal 

governments or preempt tribal law. 

The Congressional Review Act, 5 

U.S.C. 801 et seq., as added by the Small 

Business Regulatory Enforcement 

Fairness Act of 1996, generally provides 

that before a rule may take effect, the 

agency promulgating the rule must 

submit a rule report, which includes a 

copy of the rule, to each House of the 

Congress and to the Comptroller General 

of the United States. EPA will submit a 

report containing this action and other 

required information to the U.S. Senate, 

the U.S. House of Representatives, and 

the Comptroller General of the United 

States prior to publication of the rule in 

the Federal Register. A major rule 

cannot take effect until 60 days after it 

is published in the Federal Register. 

This action is not a ‘‘major rule’’ as 

defined by 5 U.S.C. 804(2). 

Under section 307(b)(1) of the CAA, 

petitions for judicial review of this 

action must be filed in the United States 

Court of Appeals for the appropriate 

circuit by April 18, 2022. Filing a 

petition for reconsideration by the 

Administrator of this final rule does not 

affect the finality of this action for the 

purposes of judicial review nor does it 

extend the time within which a petition 

for judicial review may be filed, and 

shall not postpone the effectiveness of 

such rule or action. This action may not 

be challenged later in proceedings to 

enforce its requirements. (See section 

307(b)(2)). 

List of Subjects in 40 CFR Part 52 

Environmental protection, Air 

pollution control, Carbon monoxide, 

Incorporation by reference, 

Intergovernmental relations, Lead, 

Nitrogen dioxide, Ozone, Particulate 

matter, Reporting and recordkeeping 

requirements, Sulfur oxides, Volatile 

organic compounds. 

Dated: February 10, 2022. 

Michelle L. Pirzadeh, 

Acting Regional Administrator, Region 10. 

For the reasons set forth in the 

preamble, 40 CFR part 52 is amended as 

follows: 

PART 52—APPROVAL AND 

PROMULGATION OF 

IMPLEMENTATION PLANS 

■ 1. The authority citation for part 52 

continues to read as follows: 

Authority: 42 U.S.C. 7401 et seq. 

Subpart C—Alaska 

§ 52.70 [Amended] 

■ 2. In § 52.70, the table in paragraph (c) 

is amended by removing the entry ‘‘18 

AAC 50.240’’ under the heading ‘‘18 

AAC 50—Article 2. Program 

Administration’’. 

[FR Doc. 2022–03303 Filed 2–16–22; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2021–0840; FRL–9416–01– 

OCSPP] 

[Oxirane, 2-(Phenoxymethyl)-, Polymer 

With Oxirane, Ether With 2,2′,2′′- 

Nitrilotris[Ethanol] (3:1), Diblock; 

Tolerance Exemption 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes an 

exemption from the requirement of a 

tolerance for residues of oxirane, 2- 

(phenoxymethyl)-, polymer with 

oxirane, ether with 2,2′,2′′- 

nitrilotris[ethanol] (3:1), diblock (CAS 

Reg. No. 2307555–89–9), when used as 

an inert ingredient in a pesticide 

chemical formulation. Spring 

Regulatory Sciences, on behalf of Stepan 

Company, submitted a petition to EPA 

under the Federal Food, Drug, and 

Cosmetic Act (FFDCA), requesting an 

exemption from the requirement of a 

tolerance. This regulation eliminates the 

need to establish a maximum 

permissible level for residues of oxirane, 

2-(phenoxymethyl)-, polymer with 

oxirane, ether with 2,2′,2′′- 

nitrilotris[ethanol] (3:1), diblock on food 

or feed commodities. 


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8954 Federal Register / Vol. 87, No. 33 / Thursday, February 17, 2022 / Rules and Regulations 

DATES: This regulation is effective 

February 17, 2022. Objections and 

requests for hearings must be received 

on or before April 18, 2022, and must 

be filed in accordance with the 

instructions provided in 40 CFR part 

178 (see also Unit I.C. of the 

SUPPLEMENTARY INFORMATION). 

ADDRESSES: The docket for this action, 

identified by docket identification (ID) 

number EPA–HQ–OPP–2021–0840, is 

available at https://www.regulations.gov 

or at the Office of Pesticide Programs 

Regulatory Public Docket (OPP Docket) 

in the Environmental Protection Agency 

Docket Center (EPA/DC), West William 

Jefferson Clinton Bldg., Rm. 3334, 1301 

Constitution Ave. NW, Washington, DC 

20460–0001. The Public Reading Room 

is open from 8:30 a.m. to 4:30 p.m., 

Monday through Friday, excluding legal 

holidays. The telephone number for the 

Public Reading Room is (202) 566–1744, 

and the telephone number for the OPP 

Docket is (703) 305–5805. 

Due to the public health concerns 

related to COVID–19, the EPA Docket 

Center (EPA/DC) and Reading Room is 

closed to visitors with limited 

exceptions. The staff continues to 

provide remote customer service via 

email, phone, and webform. For the 

latest status information on EPA/DC 

services and docket access, visit https:// 

www.epa.gov/dockets. 

FOR FURTHER INFORMATION CONTACT: 

Marietta Echeverria, Registration 

Division (7505P), Office of Pesticide 

Programs, Environmental Protection 

Agency, 1200 Pennsylvania Ave. NW, 

Washington, DC 20460–0001; main 

telephone number: (703) 305–7090; 

email address: RDFRNotices@epa.gov. 

SUPPLEMENTARY INFORMATION: 

I. General Information 

A. Does this action apply to me? 

You may be potentially affected by 

this action if you are an agricultural 

producer, food manufacturer, or 

pesticide manufacturer. The following 

list of North American Industrial 

Classification System (NAICS) codes is 

not intended to be exhaustive, but rather 

provides a guide to help readers 

determine whether this document 

applies to them. Potentially affected 

entities may include: 

• Crop production (NAICS code 111). 

• Animal production (NAICS code 

112). 

• Food manufacturing (NAICS code 

311). 

• Pesticide manufacturing (NAICS 

code 32532). 

B. How can I get electronic access to 

other related information? 

You may access a frequently updated 

electronic version of 40 CFR part 180 

through the Office of the Federal 

Register’s e-CFR site at https://

www.ecfr.gov/current/title-40. 

C. Can I file an objection or hearing 

request? 

Under FFDCA section 408(g), 21 

U.S.C. 346a, any person may file an 

objection to any aspect of this regulation 

and may also request a hearing on those 

objections. You must file your objection 

or request a hearing on this regulation 

in accordance with the instructions 

provided in 40 CFR part 178. To ensure 

proper receipt by EPA, you must 

identify docket ID number EPA–HQ– 

OPP–2021–0840 in the subject line on 

the first page of your submission. All 

objections and requests for a hearing 

must be in writing and must be received 

by the Hearing Clerk on or before April 

18, 2022. Addresses for mail and hand 

delivery of objections and hearing 

requests are provided in 40 CFR 

178.25(b). 

In addition to filing an objection or 

hearing request with the Hearing Clerk 

as described in 40 CFR part 178, please 

submit a copy of the filing (excluding 

any Confidential Business Information 

(CBI)) for inclusion in the public docket. 

Information not marked confidential 

pursuant to 40 CFR part 2 may be 

disclosed publicly by EPA without prior 

notice. Submit the non-CBI copy of your 

objection or hearing request, identified 

by docket ID number EPA–HQ–OPP– 

2021–0840, by one of the following 

methods. 

• Federal eRulemaking Portal: 

https://www.regulations.gov. Follow the 

online instructions for submitting 

comments. Do not submit electronically 

any information you consider to be CBI 

or other information whose disclosure is 

restricted by statute. 

• Mail: OPP Docket, Environmental 

Protection Agency Docket Center (EPA/ 

DC), (28221T), 1200 Pennsylvania Ave. 

NW, Washington, DC 20460–0001. 

• Hand Delivery: To make special 

arrangements for hand delivery or 

delivery of boxed information, please 

follow the instructions at https://

www.epa.gov/dockets/contacts.html. 

Additional instructions on 

commenting or visiting the docket, 

along with more information about 

dockets generally, is available at https:// 

www.epa.gov/dockets. 

II. Background and Statutory Findings 

In the Federal Register of December 

21, 2021 (86 FR 72201) (FRL–8792–06), 

EPA issued a document pursuant to 

FFDCA section 408, 21 U.S.C. 346a, 

announcing the receipt of a pesticide 

petition (PP IN–11646) filed by Spring 

Regulatory Sciences (6620 Cypresswood 

Dr., Suite 250, Spring, TX 77379), on 

behalf of Stepan Company (22 W 

Frontage Rd., Northfield, IL 60093). The 

petition requested that 40 CFR 180.960 

be amended by establishing an 

exemption from the requirement of a 

tolerance for residues of oxirane, 2- 

(phenoxymethyl)-, polymer with 

oxirane, ether with 2,2′,2′′- 

nitrilotris[ethanol] (3:1), diblock (CAS 

Reg. No. 2307555–89–9). That document 

included a summary of the petition 

prepared by the petitioner and solicited 

comments on the petitioner’s request. 

The Agency did not receive any 

substantive public comments. 

Section 408(c)(2)(A)(i) of FFDCA 

allows EPA to establish an exemption 

from the requirement for a tolerance (the 

legal limit for a pesticide chemical 

residue in or on a food) only if EPA 

determines that the exemption is ‘‘safe.’’ 

Section 408(c)(2)(A)(ii) of FFDCA 

defines ‘‘safe’’ to mean that ‘‘there is a 

reasonable certainty that no harm will 

result from aggregate exposure to the 

pesticide chemical residue, including 

all anticipated dietary exposures and all 

other exposures for which there is 

reliable information.’’ This includes 

exposure through drinking water and 

use in residential settings but does not 

include occupational exposure. Section 

408(b)(2)(C) of FFDCA requires EPA to 

give special consideration to exposure 

of infants and children to the pesticide 

chemical residue in establishing an 

exemption from the requirement of a 

tolerance and to ‘‘ensure that there is a 

reasonable certainty that no harm will 

result to infants and children from 

aggregate exposure to the pesticide 

chemical residue . . .’’ and specifies 

factors EPA is to consider in 

establishing an exemption. 

III. Risk Assessment and Statutory 

Findings 

EPA establishes exemptions from the 

requirement of a tolerance only in those 

cases where it can be shown that the 

risks from aggregate exposure to 

pesticide chemical residues under 

reasonably foreseeable circumstances 

will pose no appreciable risks to human 

health. To determine the risks from 

aggregate exposure to pesticide inert 

ingredients, the Agency considers the 

toxicity of the inert in conjunction with 

possible exposure to residues of the 

inert ingredient through food, drinking 

water, and through other exposures that 

occur as a result of pesticide use in 

residential settings. If EPA is able to 


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Federal Register / Vol. 87, No. 33 / Thursday, February 17, 2022 / Rules and Regulations 8955 

determine that a finite tolerance is not 

necessary to ensure that there is a 

reasonable certainty that no harm will 

result from aggregate exposure to the 

inert ingredient, an exemption from the 

requirement of a tolerance may be 

established. 

Consistent with FFDCA section 

408(b)(2)(D), EPA has reviewed the 

available scientific data and other 

relevant information in support of this 

action and considered its validity, 

completeness and reliability and the 

relationship of this information to 

human risk. EPA has also considered 

available information concerning the 

variability of the sensitivities of major 

identifiable subgroups of consumers, 

including infants and children. In the 

case of certain chemical substances that 

are defined as polymers, the Agency has 

established a set of criteria to identify 

categories of polymers expected to 

present minimal or no risk. The 

definition of a polymer is given in 40 

CFR 723.250(b) and the exclusion 

criteria for identifying these low-risk 

polymers are described in 40 CFR 

723.250(d). Oxirane, 2- 

(phenoxymethyl)-, polymer with 

oxirane, ether with 2,2′,2′′- 

nitrilotris[ethanol] (3:1), diblock (CAS 

Reg. No. 2307555–89–9) conforms to the 

definition of a polymer given in 40 CFR 

723.250(b) and meets the following 

criteria that are used to identify low-risk 

polymers. 

1. The polymer is not a cationic 

polymer nor is it reasonably anticipated 

to become a cationic polymer in a 

natural aquatic environment. 

2. The polymer does contain as an 

integral part of its composition at least 

two of the atomic elements carbon, 

hydrogen, nitrogen, oxygen, silicon, and 

sulfur. 

3. The polymer does not contain as an 

integral part of its composition, except 

as impurities, any element other than 

those listed in 40 CFR 723.250(d)(2)(ii). 

4. The polymer is neither designed 

nor can it be reasonably anticipated to 

substantially degrade, decompose, or 

depolymerize: An adequate 

biodegradation study (MRID 51712502) 

was submitted for oxirane, 2- 

(phenoxymethyl)-, polymer with 

oxirane, ether with 2,2′,2′′- 

nitrilotris[ethanol] (3:1), diblock 

showing lack of biodegradation (10.6% 

at 28 days, 13% at 90 days). 

5. The polymer is manufactured or 

imported from monomers and/or 

reactants that are already included on 

the Toxic Substances Control Act 

(TSCA) Chemical Substance Inventory 

or manufactured under an applicable 

TSCA section 5 exemption. 

6. The polymer is not a water 

absorbing polymer with a number 

average molecular weight (MW) greater 

than or equal to 10,000 daltons. 

7. The polymer does not contain 

certain perfluoroalkyl moieties 

consisting of a CF3- or longer chain 

length as listed in 40 CFR 723.250(d)(6). 

Additionally, the polymer also meets 

as required the following exemption 

criteria specified in 40 CFR 723.250(e). 

The polymer’s number average 

molecular weight is greater than or 

equal to 1,000 daltons and less than 

10,000 daltons (5483 daltons). Also, the 

polymer contains less than 2% 

oligomeric material below MW 500 

(2.0%) and less than 5% oligomeric 

material below MW 1,000 (3.5%). 

Thus, Oxirane, 2-(phenoxymethyl)-, 

polymer with oxirane, ether with 

2,2′,2′′-nitrilotris[ethanol] (3:1), diblock 

(CAS Reg. No. 2307555–89–9) meets the 

criteria for a polymer to be considered 

low risk under 40 CFR 723.250. Based 

on its conformance to the criteria in this 

unit, no mammalian toxicity is 

anticipated from dietary, inhalation, or 

dermal exposure to oxirane, 2- 

(phenoxymethyl)-, polymer with 

oxirane, ether with 2,2′,2′′- 

nitrilotris[ethanol] (3:1), diblock. 

IV. Aggregate Exposures 

For the purposes of assessing 

potential exposure under this 

exemption, EPA considered that 

oxirane, 2-(phenoxymethyl)-, polymer 

with oxirane, ether with 2,2′,2′′- 

nitrilotris[ethanol] (3:1), diblock could 

be present in all raw and processed 

agricultural commodities and drinking 

water, and that non-occupational nondietary exposure was possible. The 

minimum number average MW of 

oxirane, 2-(phenoxymethyl)-, polymer 

with oxirane, ether with 2,2′,2′′- 

nitrilotris[ethanol] (3:1), diblock is 5,300 

daltons. Generally, a polymer of this 

size would be poorly absorbed through 

the intact gastrointestinal tract or 

through intact human skin. Since 

oxirane, 2-(phenoxymethyl)-, polymer 

with oxirane, ether with 2,2′,2′′- 

nitrilotris[ethanol] (3:1), diblock 

conforms to the criteria that identify a 

low-risk polymer, there are no concerns 

for risks associated with any potential 

exposure scenarios that are reasonably 

foreseeable. The Agency has determined 

that a tolerance is not necessary to 

protect the public health. 

V. Cumulative Effects From Substances 

With a Common Mechanism of Toxicity 

Section 408(b)(2)(D)(v) of FFDCA 

requires that, when considering whether 

to establish, modify, or revoke a 

tolerance, the Agency consider 

‘‘available information’’ concerning the 

cumulative effects of a particular 

pesticide’s residues and ‘‘other 

substances that have a common 

mechanism of toxicity.’’ 

EPA has not found oxirane, 2- 

(phenoxymethyl)-, polymer with 

oxirane, ether with 2,2′,2′′- 

nitrilotris[ethanol] (3:1), diblock to 

share a common mechanism of toxicity 

with any other substances, and oxirane, 

2-(phenoxymethyl)-, polymer with 

oxirane, ether with 2,2′,2′′- 

nitrilotris[ethanol] (3:1), diblock does 

not appear to produce a toxic metabolite 

produced by other substances. For the 

purposes of this tolerance action, 

therefore, EPA has assumed that 

oxirane, 2-(phenoxymethyl)-, polymer 

with oxirane, ether with 2,2′,2′′- 

nitrilotris[ethanol] (3:1), diblock does 

not have a common mechanism of 

toxicity with other substances. For 

information regarding EPA’s efforts to 

determine which chemicals have a 

common mechanism of toxicity and to 

evaluate the cumulative effects of such 

chemicals, see EPA’s website at https:// 

www.epa.gov/pesticides/cumulative. 

VI. Additional Safety Factor for the 

Protection of Infants and Children 

Section 408(b)(2)(C) of FFDCA 

provides that EPA shall apply an 

additional tenfold margin of safety for 

infants and children in the case of 

threshold effects to account for prenatal 

and postnatal toxicity and the 

completeness of the data base unless 

EPA concludes that a different margin of 

safety will be safe for infants and 

children. Due to the expected low 

toxicity of oxirane, 

2-(phenoxymethyl)-, polymer with 

oxirane, ether with 2,2′,2′′- 

nitrilotris[ethanol] (3:1), diblock, EPA 

has not used a safety factor analysis to 

assess the risk. For the same reasons the 

additional tenfold safety factor is 

unnecessary. 

VII. Determination of Safety 

Based on the conformance to the 

criteria used to identify a low-risk 

polymer, EPA concludes that there is a 

reasonable certainty of no harm to the 

U.S. population, including infants and 

children, from aggregate exposure to 

residues of oxirane, 

2-(phenoxymethyl)-, polymer with 

oxirane, ether with 2,2′,2′′- 

nitrilotris[ethanol] (3:1), diblock. 

VIII. Other Considerations 

A. Analytical Enforcement Methodology 

An analytical method is not required 

for enforcement purposes since the 

Agency is establishing an exemption 


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8956 Federal Register / Vol. 87, No. 33 / Thursday, February 17, 2022 / Rules and Regulations 

from the requirement of a tolerance 

without any numerical limitation. 

B. International Residue Limits 

In making its tolerance decisions, EPA 

seeks to harmonize U.S. tolerances with 

international standards whenever 

possible, consistent with U.S. food 

safety standards and agricultural 

practices. EPA considers the 

international maximum residue limits 

(MRLs) established by the Codex 

Alimentarius Commission (Codex), as 

required by FFDCA section 408(b)(4). 

The Codex Alimentarius is a joint 

United Nations Food and Agriculture 

Organization/World Health 

Organization food standards program, 

and it is recognized as an international 

food safety standards-setting 

organization in trade agreements to 

which the United States is a party. EPA 

may establish a tolerance that is 

different from a Codex MRL; however, 

FFDCA section 408(b)(4) requires that 

EPA explain the reasons for departing 

from the Codex level. 

The Codex has not established a MRL 

for oxirane, 2-(phenoxymethyl)-, 

polymer with oxirane, ether with 

2,2′,2′′-nitrilotris[ethanol] (3:1), diblock. 

IX. Conclusion 

Accordingly, EPA finds that 

exempting residues of oxirane, 2- 

(phenoxymethyl)-, polymer with 

oxirane, ether with 2,2′,2′′- 

nitrilotris[ethanol] (3:1), diblock from 

the requirement of a tolerance will be 

safe. 

X. Statutory and Executive Order 

Reviews 

This action establishes a tolerance 

under FFDCA section 408(d) in 

response to a petition submitted to the 

Agency. The Office of Management and 

Budget (OMB) has exempted these types 

of actions from review under Executive 

Order 12866, entitled ‘‘Regulatory 

Planning and Review’’ (58 FR 51735, 

October 4, 1993). Because this action 

has been exempted from review under 

Executive Order 12866, this action is 

not subject to Executive Order 13211, 

entitled ‘‘Actions Concerning 

Regulations That Significantly Affect 

Energy Supply, Distribution, or Use’’ (66 

FR 28355, May 22, 2001) or Executive 

Order 13045, entitled ‘‘Protection of 

Children from Environmental Health 

Risks and Safety Risks’’ (62 FR 19885, 

April 23, 1997). This action does not 

contain any information collections 

subject to OMB approval under the 

Paperwork Reduction Act (PRA) (44 

U.S.C. 3501 et seq.), nor does it require 

any special considerations under 

Executive Order 12898, entitled 

‘‘Federal Actions to Address 

Environmental Justice in Minority 

Populations and Low-Income 

Populations’’ (59 FR 7629, February 16, 

1994). 

Since tolerances and exemptions that 

are established on the basis of a petition 

under FFDCA section 408(d), such as 

the tolerance in this final rule, do not 

require the issuance of a proposed rule, 

the requirements of the Regulatory 

Flexibility Act (RFA) (5 U.S.C. 601 et 

seq.), do not apply. 

This action directly regulates growers, 

food processors, food handlers, and food 

retailers, not States or Tribes, nor does 

this action alter the relationships or 

distribution of power and 

responsibilities established by Congress 

in the preemption provisions of FFDCA 

section 408(n)(4). As such, the Agency 

has determined that this action will not 

have a substantial direct effect on States 

or Tribal Governments, on the 

relationship between the National 

Government and the States or Tribal 

Governments, or on the distribution of 

power and responsibilities among the 

various levels of government or between 

the Federal Government and Indian 

Tribes. Thus, the Agency has 

determined that Executive Order 13132, 

entitled ‘‘Federalism’’ (64 FR 43255, 

August 10, 1999) and Executive Order 

13175, entitled ‘‘Consultation and 

Coordination with Indian Tribal 

Governments’’ (65 FR 67249, November 

9, 2000) do not apply to this action. In 

addition, this action does not impose 

any enforceable duty or contain any 

unfunded mandate as described under 

Title II of the Unfunded Mandates 

Reform Act (UMRA) (2 U.S.C. 1501 et 

seq.). 

This action does not involve any 

technical standards that would require 

Agency consideration of voluntary 

consensus standards pursuant to section 

12(d) of the National Technology 

Transfer and Advancement Act 

(NTTAA) (15 U.S.C. 272 note). 

XI. Congressional Review Act 

Pursuant to the Congressional Review 

Act (5 U.S.C. 801 et seq.), EPA will 

submit a report containing this rule and 

other required information to the U.S. 

Senate, the U.S. House of 

Representatives, and the Comptroller 

General of the United States prior to 

publication of the rule in the Federal 

Register. This action is not a ‘‘major 

rule’’ as defined by 5 U.S.C. 804(2). 

List of Subjects in 40 CFR Part 180 

Environmental protection, 

Administrative practice and procedure, 

Agricultural commodities, Pesticides 

and pests, Reporting and recordkeeping 

requirements. 

Dated: February 8, 2022. 

Marietta Echeverria, 

Acting Director, Registration Division, Office 

of Pesticide Programs. 

Therefore, for the reasons stated in the 

preamble, EPA is amending 40 CFR 

chapter I as follows: 

PART 180—TOLERANCES AND 

EXEMPTIONS FOR PESTICIDE 

CHEMICAL RESIDUES IN FOOD 

■ 1. The authority citation for part 180 

continues to read as follows: 

Authority: 21 U.S.C. 321(q), 346a and 371. 

■ 2. In § 180.960, amend Table 1 to 

§ 180.960, by adding in alphabetical 

order the polymer ‘‘Oxirane, 2- 

(phenoxymethyl)-, polymer with 

oxirane, ether with 2,2′,2′′- 

nitrilotris[ethanol] (3:1), diblock, 

minimum number average molecular 

weight (in amu), 5,300’’ to read as 

follows: 

§ 180.960 Polymers; exemptions from the 

requirement of a tolerance. 

* * * * * 

TABLE 1 TO § 180.960 

Polymer CAS No. 

*******

Oxirane, 2-(phenoxymethyl)-, polymer with oxirane, ether with 2,2′,2′′-nitrilotris[ethanol] (3:1), diblock, minimum number average molecular weight (in amu), 5,300 ........................................................................................................................................... 2307555–89–9 

* * * * * * * 


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[FR Doc. 2022–03456 Filed 2–16–22; 8:45 am] 

BILLING CODE 6560–50–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

45 CFR Part 5b 

[Docket Number NIH–2016–0002] 

RIN 0925–AA62 

Privacy Act; Implementation 

AGENCY: Department of Health and 

Human Services. 

ACTION: Final rule. 

SUMMARY: The Department of Health and 

Human Services (HHS or Department) is 

issuing this final rule to make effective 

the exemptions that were previously 

proposed for a subset of records covered 

in a new Privacy Act system of records, 

No. 09–25–0165, NIH Loan Repayment 

Records, which is maintained by the 

National Institutes of Health (NIH). The 

system of records covers records used to 

manage and evaluate the Loan 

Repayment Programs (LRPs) at NIH. The 

exemptions are necessary to maintain 

the integrity of the NIH peer review and 

award processes by enabling NIH to 

protect the identities of reviewers. 

DATES: This final rule is effective 

February 17, 2022. 

FOR FURTHER INFORMATION CONTACT: 

Dustin Close, Office of Management 

Assessment, National Institutes of 

Health, 6705 Rockledge Drive, Suite 

601, Bethesda, Maryland 20892, 

telephone 301–402–6469, email 

privacy@mail.nih.gov. 

SUPPLEMENTARY INFORMATION: The NIH 

Loan Repayment Programs (LRPs) are 

administered by the Division of Loan 

Repayment (DLR) within NIH’s Office of 

Extramural Research. DLR provides 

repayment of student loans for approved 

applicants to encourage outstanding 

health professionals to pursue careers in 

biomedical, behavioral, social, and 

clinical research. Research health 

professionals who owe qualified 

educational debt and who meet 

eligibility criteria may apply for student 

loan repayment. A peer review process 

recommends applicants for loan 

repayments. The peer review process is 

committee-based, with a peer review 

group comprised of individual 

reviewers, referees, or other 

recommenders (hereafter collectively 

referred to as Reviewers). Reviewers are 

primarily non-government experts 

qualified by training and experience in 

scientific or technical fields, or as 

authorities knowledgeable in disciplines 

and fields related to the areas under 

review. Reviewers give DLR expert 

recommendations and materials (such 

as ratings, summaries, and 

communications) about applicants’ 

suitability, eligibility, or qualifications 

for student loan repayments under 

express promises that the Reviewers 

will not be identified as the sources of 

the information. DLR uses the 

information solely for the purpose of 

determining applicants’ suitability, 

eligibility, or qualifications for Federal 

loan repayment. System of records 09– 

25–0165 covers records about health 

professionals who apply for student 

loan repayments and about other 

categories of individuals who are related 

to the applications. These records 

include material that could reveal the 

identity of the Reviewers either directly 

or indirectly. 

Under the Privacy Act of 1974, as 

amended (Privacy Act, 5 U.S.C. 552a, or 

‘‘Privacy Act’’), individuals have a right 

of access to records about themselves in 

Federal agency systems of records, and 

other rights with respect to those 

records (such as notification, 

amendment, and an accounting of 

disclosures), but the Act permits certain 

types of systems of records (identified in 

section 552a(j) and (k)) to be exempted 

from certain requirements of the Act. 

Subsection (k)(5) permits the head of an 

agency to promulgate rules to exempt 

from the requirements in subsections 

(c)(3) and (d)(1) through (4) of the Act 

investigatory material compiled solely 

for the purpose of determining 

suitability, eligibility, or qualifications 

for Federal contracts, to the extent that 

the disclosure of such material would 

reveal the identity of a source who 

furnished information to the Federal 

Government under an express promise 

that the identity of the source would be 

held in confidence. 

In accordance with the Privacy Act, 

HHS/NIH proposed to exempt material 

that would identify a confidential 

source in system of records 09–25–0165 

from the notification, access, and 

amendment requirements of the Act 

pursuant to subsection (k)(5) of the Act, 

as described in a notice of proposed 

rulemaking (NPRM) published in the 

Federal Register (86 FR 2633) for public 

comment on January 13, 2021. The 

agency also published a modified notice 

describing system of records 09–25– 

0165 (SORN) in the Federal Register (86 

FR 2677) for public comment the same 

day. The 60-day public comment period 

provided for both the SORN and the 

NRPM expired March 15, 2021. Thirteen 

comments were received on the NPRM 

and no comments were received on the 

SORN. The comments received 

applauded NIH’s efforts to exempt 

material that would identify Reviewers 

contained within the system of records 

as specified in the notice. Additionally, 

none of the commentors recommended 

any changes to the proposed exemptions 

or the SORN. Therefore, HHS/NIH has 

made no changes to the proposed 

exemptions in the NPRM or to the 

SORN. 

NIH believes the exemptions are 

necessary to maintain the integrity of 

the NIH peer review and award 

processes. Protecting Reviewer 

identities as the sources of the 

information they provide protects them 

from harassment, intimidation, and 

other attempts to improperly influence 

award outcomes, and ensures that they 

are not reluctant to provide sensitive 

information or frank assessments. Case 

law has held that exemptions 

promulgated under subsection (k)(5) 

may protect source-identifying material 

even where the identity of the source is 

known. Therefore, NIH solicits 

Reviewers to assess applicants for loan 

repayment programs under an express 

promise of confidentiality. 

The specific rationales that support 

the exemptions concerning each 

affected Privacy Act provision, are as 

follows: 

• Subsection (c)(3). An exemption 

from the requirement to provide an 

accounting of disclosures to record 

subjects is needed to protect the identity 

of any Reviewer who is expressly 

promised confidentiality. Providing an 

accounting of disclosures to an 

applicant could identify specific 

Reviewers as sources of 

recommendations or evaluative input 

received, or to be received, on the 

application. Inappropriately revealing 

the Reviewers’ identities in association 

with the nature and scope of their 

assessments or evaluations could lead 

them to alter or destroy their 

assessments or evaluations or subject 

them to harassment, intimidation, or 

other improper influence, which would 

impede or compromise the fairness and 

objectivity of the loan repayment 

application review process; constitute 

an unwarranted invasion of the personal 

privacy of the Reviewer; and violate the 

express promise of confidentiality made 

to the Reviewer. 

• Subsection (d)(1). An exemption 

from the access requirement is needed 

both during and after an application 

review proceeding to avoid 

inappropriately revealing the identity of 

the Reviewers. Protecting the Reviewers’ 

identities from access by record subjects 

is necessary to maintain the integrity of 

the review process. It ensures Reviewers 

provide candid assessments or 


lotter on DSK11XQN23PROD with RULES1