39824 Federal Register / Vol. 87, No. 127 / Tuesday, July 5, 2022 / Notices 

reduce potential exposure and risk to 

aquatic plant communities from atrazine 

via runoff from agricultural uses in field 

corn, sweet corn, sorghum and 

sugarcane. 

TABLE—REGISTRATION REVIEW FOR PROPOSED REVISIONS TO THE ATRAZINE INTERIM DECISION

Registration review case name and No. Pesticide docket ID No. Chemical review manager, telephone No., email address 

Atrazine, Case Number 0062 ................. EPA–HQ–OPP–2013–0266 ...... Alex Hazlehurst, (202) 566–2249, Hazlehurst.alexander@epa.gov. 

The registration review docket for a 

pesticide includes earlier documents 

related to the registration review of the 

case. For example, the review opened 

with a Summary Document, containing 

a Preliminary Work Plan, for public 

comment. A Final Work Plan was 

placed in the docket following public 

comment on the initial docket. The 

documents in the dockets describe 

EPA’s rationales for conducting 

additional risk assessments for the 

registration review of the pesticide 

included in the table in Unit II.A., as 

well as the Agency’s subsequent 

findings and consideration of possible 

risk mitigation measures. The proposed 

revisions to the atrazine interim 

registration review decision are 

supported by the rationales included in 

those documents. Following public 

comment, the Agency will issue the 

‘‘Revisions to the Atrazine Interim 

Registration Review Decision, Case 

0062’’ memorandum for products 

containing atrazine. 

The regulation at 40 CFR 155.58(a) 

provides for a minimum 60-day public 

comment period on all proposed interim 

and/or final registration review 

decisions. This comment period is 

limited to the proposed revisions to the 

interim registration review decision. 

The Agency is not soliciting comment 

on any other aspects of the atrazine ID 

other than those specifically identified 

in the proposed revisions to the atrazine 

ID memorandum All comments should 

be submitted using the methods in 

ADDRESSES, and must be received by 

EPA on or before the closing date. These 

comments will become part of the 

docket for atrazine. Comments received 

after the close of the comment period 

will be marked ‘‘late.’’ EPA is not 

required to consider these late 

comments. 

The Agency will carefully consider all 

comments related to the proposed 

revisions to the atrazine ID received by 

the closing date and will provide a 

‘‘Response to Comments Memorandum’’ 

in the docket. The revisions to the 

atrazine interim registration review 

decision memorandum will explain the 

effect that any comments had on the 

revisions to the atrazine interim 

registration review decision and provide 

the Agency’s response to significant 

comments. 

Background on the registration review 

program is provided at: https://

www.epa.gov/pesticide-reevaluation. 

Links to earlier documents related to the 

registration review of this pesticide are 

provided at: https://

www.regulations.gov/docket/EPA-HQOPP-2013-0266. 

Authority: 7 U.S.C. 136 et seq. 

Dated: June 23, 2022. 

Mary Reaves, 

Director, Pesticide Re-Evaluation Division, 

Office of Pesticide Programs. 

[FR Doc. 2022–14255 Filed 7–1–22; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

[EPA–HQ–OPPT–2016–0742 FRL–9946–01– 

OCSPP] 

Methylene Chloride; Draft Revision to 

Toxic Substances Control Act (TSCA) 

Risk Determination; Notice of 

Availability and Request for Comment 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Notice. 

SUMMARY: The Environmental Protection 

Agency (EPA) is announcing the 

availability of and seeking public 

comment on a draft revision to the risk 

determination for the methylene 

chloride risk evaluation issued under 

TSCA. The draft revision to the 

methylene chloride risk determination 

reflects the announced policy changes 

to ensure the public is protected from 

unreasonable risks from chemicals in a 

way that is supported by science and 

the law. In this draft revision to the risk 

determination EPA finds that methylene 

chloride, as a whole chemical 

substance, presents an unreasonable risk 

of injury to health when evaluated 

under its conditions of use. In addition, 

this revised risk determination does not 

reflect an assumption that all workers 

always appropriately wear personal 

protective equipment (PPE). EPA 

understands that there could be 

occupational safety protections in place 

at workplace locations; however, not 

assuming use of PPE reflects EPA’s 

recognition that unreasonable risk may 

exist for subpopulations of workers that 

may be highly exposed because they are 

not covered by OSHA standards, or their 

employers are out of compliance with 

OSHA standards, or because many of 

OSHA’s chemical-specific permissible 

exposure limits largely adopted in the 

1970’s are described by OSHA as being 

‘‘outdated and inadequate for ensuring 

protection of worker health,’’ or because 

the OSHA permissible exposure limit 

(PEL) alone may be inadequate for 

ensuring protection of worker health. 

This revision, when final, would 

supersede the condition of use-specific 

no unreasonable risk determinations in 

the June 2020 methylene chloride risk 

evaluation (and withdraw the associated 

order) and would make a revised 

determination of unreasonable risk for 

methylene chloride as a whole chemical 

substance. 

DATES: Comments must be received on 

or before August 4, 2022. 

ADDRESSES: Submit your comments, 

identified by docket identification (ID) 

number EPA–EPA–HQ–OPPT–2016– 

0742, using the Federal eRulemaking 

Portal at https://www.regulations.gov. 

Follow the online instructions for 

submitting comments. Do not submit 

electronically any information you 

consider to be Confidential Business 

Information (CBI) or other information 

whose disclosure is restricted by statute. 

Additional instructions on commenting 

and visiting the docket, along with more 

information about dockets generally, is 

available at https://www.epa.gov/ 

dockets. 

FOR FURTHER INFORMATION CONTACT: For 

technical information contact: Ingrid 

Feustel, Office of Pollution Prevention 

and Toxics (7404M), Environmental 

Protection Agency, 1200 Pennsylvania 

Ave. NW, Washington, DC 20460–0001; 

telephone number: (202) 564–3199; 

email address: feustel.ingrid@epa.gov. 

For general information contact: The 

TSCA-Hotline, ABVI-Goodwill, 422 

South Clinton Ave., Rochester, NY 

14620; telephone number: (202) 554– 

1404; email address: TSCA-Hotline@

epa.gov. 

SUPPLEMENTARY INFORMATION: 


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I. Executive Summary 

A. Does this action apply to me? 

This action is directed to the public 

in general. This action may, however, be 

of interest to those involved in the 

manufacture, processing, distribution, 

use, disposal, and/or the assessment of 

risks involving chemical substances and 

mixtures. You may be potentially 

affected by this action if you 

manufacture (defined under TSCA to 

include import), process (including 

recycling), distribute in commerce, use 

or dispose of methylene chloride, 

including methylene chloride in 

products. Since other entities may also 

be interested in this draft revision to the 

risk determination, EPA has not 

attempted to describe all the specific 

entities that may be affected by this 

action. 

B. What is EPA’s authority for taking 

this action? 

TSCA section 6, 15 U.S.C. 2605, 

requires EPA to conduct risk 

evaluations to determine whether a 

chemical substance presents an 

unreasonable risk of injury to health or 

the environment, without consideration 

of costs or other non-risk factors, 

including an unreasonable risk to a 

potentially exposed or susceptible 

subpopulation (PESS) identified as 

relevant to the risk evaluation by the 

Administrator, under the conditions of 

use. 15 U.S.C. 2605(b)(4)(A). TSCA 

sections 6(b)(4)(A) through (H) 

enumerate the deadlines and minimum 

requirements applicable to this process, 

including provisions that provide 

instruction on chemical substances that 

must undergo evaluation, the minimum 

components of a TSCA risk evaluation, 

and the timelines for public comment 

and completion of the risk evaluation. 

TSCA also requires that EPA operate in 

a manner that is consistent with the best 

available science, make decisions based 

on the weight of the scientific evidence, 

and consider reasonably available 

information. 15 U.S.C. 2625(h), (i), and 

(k). 

The statute identifies the minimum 

components for all chemical substance 

risk evaluations. For each risk 

evaluation, EPA must publish a 

document that outlines the scope of the 

risk evaluation to be conducted, which 

includes the hazards, exposures, 

conditions of use, and the potentially 

exposed or susceptible subpopulations 

that EPA expects to consider. 15 U.S.C. 

2605(b)(4)(D). The statute further 

provides that each risk evaluation must 

also: (1) integrate and assess available 

information on hazards and exposures 

for the conditions of use of the chemical 

substance, including information that is 

relevant to specific risks of injury to 

health or the environment and 

information on relevant potentially 

exposed or susceptible subpopulations; 

(2) describe whether aggregate or 

sentinel exposures were considered and 

the basis for that consideration; (3) take 

into account, where relevant, the likely 

duration, intensity, frequency, and 

number of exposures under the 

conditions of use; and (4) describe the 

weight of the scientific evidence for the 

identified hazards and exposures. 15 

U.S.C. 2605(b)(4)(F)(i) through (ii) and 

(iv) through (v). Each risk evaluation 

must not consider costs or other nonrisk factors. 15 U.S.C. 2605(b)(4)(F)(iii). 

EPA has inherent authority to 

reconsider previous decisions and to 

revise, replace, or repeal a decision to 

the extent permitted by law and 

supported by reasoned explanation. FCC 

v. Fox Television Stations, Inc., 556 U.S. 

502, 515 (2009); see also Motor Vehicle 

Mfrs. Ass’n v. State Farm Mutual Auto. 

Ins. Co., 463 U.S. 29, 42 (1983). Further, 

on July 14, 2021, the Ninth Circuit 

granted EPA’s motion for voluntary 

remand without vacatur, so that EPA 

may conduct reconsideration 

proceedings on the methylene chloride 

Risk Evaluation—particularly to 

reconsider the no unreasonable risk 

determinations made within. Neighbors 

for Environmental Justice et al., v. U.S. 

Environmental Protection Agency et al., 

(9th Cir. No. 20–72091). 

C. What action is EPA taking? 

EPA is announcing the availability of 

and seeking public comment on a draft 

revision to the risk determination for the 

risk evaluation for methylene chloride 

under TSCA, which was initially 

published in June 2020 (Ref. 1). EPA is 

specifically seeking public comment on 

the draft revision to the risk 

determination for the risk evaluation 

where the Agency intends to determine 

that methylene chloride, as a whole 

chemical, presents an unreasonable risk 

of injury to health when evaluated 

under its conditions of use. The 

Agency’s risk determination for 

methylene chloride is better 

characterized as a whole chemical risk 

determination rather than condition-ofuse-specific risk determinations. 

Accordingly, EPA would revise and 

replace section 5 of the risk evaluation 

for methylene chloride where the 

findings of unreasonable risk to health 

were previously made for the individual 

conditions of use evaluated. EPA would 

also withdraw the order issued 

previously for six conditions of use 

previously determined not to present 

unreasonable risk. 

This revision would be consistent 

with EPA’s plans to revise specific 

aspects of the first ten TSCA chemical 

risk evaluations in order to ensure that 

the risk evaluations better align with 

TSCA’s objective of protecting health 

and the environment. Under the draft 

revision, removing the assumption that 

workers always appropriately wear PPE 

(see Unit II.C.) in making the whole 

chemical risk determination for 

methylene chloride would mean that: 

five additional conditions of use in 

addition to the original 47 would drive 

the unreasonable risk determination for 

methylene chloride; inhalation risks to 

workers in addition to the previously 

identified inhalation risk to 

occupational non-users (ONUs) would 

drive the unreasonable risk in three 

conditions of use; and additional risk to 

workers for acute and chronic noncancer dermal exposures and for cancer 

from inhalation exposures would also 

drive the unreasonable risk in many of 

those 52 conditions of use (where 

previously those conditions of use were 

identified as presenting unreasonable 

risk only for chronic non-cancer effects 

and/or for acute effects) (Ref. 2 at pg. 

319 provides the risk estimates, and 

Table 5–1 in the risk determination (Ref. 

1) provides information related to the 

unreasonable risk). Overall, 52 

conditions of use out of 53EPA 

evaluated would drive the methylene 

chloride whole chemical unreasonable 

risk determination due to risks 

identified for human health. The full list 

of the conditions of use evaluated for 

the methylene chloride TSCA risk 

evaluation is in Tables 4–2 and 4–3 of 

the risk evaluation (Ref. 2). 

D. What should I consider as I prepare 

my comments for EPA? 

1. Submitting CBI. Do not submit this 

information to EPA through 

regulations.gov or email. Clearly mark 

the part or all of the information that 

you claim to be CBI. For CBI 

information in a disk or CD–ROM that 

you mail to EPA, mark the outside of the 

disk or CD–ROM as CBI and then 

identify electronically within the disk or 

CD–ROM the specific information that 

is claimed CBI. In addition to one 

complete version of the comment that 

includes information claimed as CBI, a 

copy of the comment that does not 

contain the information claimed as CBI 

must be submitted for inclusion in the 

public docket. Information so marked 

will not be disclosed except in 

accordance with procedures set forth in 

40 CFR part 2. 

2. Tips for preparing your comments. 

When preparing and submitting your 

comments, see the commenting tips at 


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https://www.epa.gov/dockets/ 

comments.html. 

II. Background 

A. Why is EPA re-issuing the risk 

determination for the methylene 

chloride risk evaluation conducted 

under TSCA? 

In 2016, as directed by TSCA section 

6(b)(2)(A), EPA chose the first ten 

chemical substances to undergo risk 

evaluations under the amended TSCA. 

These chemical substances are asbestos, 

1-bromopropane, carbon tetrachloride, 

C.I. Pigment Violet 29, HBCD, 1,4- 

dioxane, methylene chloride, nmethylpyrrolidone (NMP), 

perchloroethylene (PCE), and 

trichloroethylene (TCE). 

From June 2020 to January 2021, EPA 

published risk evaluations on the first 

ten chemical substances, including for 

methylene chloride in June 2020. The 

risk evaluations included individual 

unreasonable risk determinations for 

each condition of use evaluated. EPA 

issued determinations that particular 

conditions of use did not present an 

unreasonable risk by order under TSCA 

section 6(i)(1). 

In accordance with Executive Order 

13990 (Ref. 3) and other Administration 

priorities (Refs. 4, 5, and 6), EPA 

reviewed the risk evaluations for the 

first ten chemical substances, including 

methylene chloride, to ensure that they 

meet the requirements of TSCA, 

including conducting decision making 

in a manner that is consistent with the 

best available science. 

As a result of this review, EPA 

announced plans to revise specific 

aspects of the first ten risk evaluations 

in order to ensure that the risk 

evaluations appropriately identify 

unreasonable risks and thereby help 

ensure the protection of human health 

and the environment (Ref. 7). To that 

end, EPA is reconsidering two key 

aspects of the risk determinations for 

methylene chloride published in June 

2020. First, following a review of 

specific aspects of the June 2020 

methylene chloride risk evaluation, EPA 

proposes that making an unreasonable 

risk determination for HBCD as a whole 

chemical substance, rather than making 

unreasonable risk determinations 

separately on each individual condition 

of use evaluated in the risk evaluation, 

is the most appropriate approach to 

HBCD under the statute and 

implementing regulations. Second, EPA 

proposes that the risk determination 

should be explicit that it does not rely 

on assumptions regarding the use of 

personal protective equipment (PPE) in 

making the unreasonable risk 

determination under TSCA section 6, 

even though some facilities might be 

using PPE as one means to reduce 

workers exposures; rather, the use of 

PPE would be considered during risk 

management as appropriate. 

Separately, EPA is conducting a 

screening approach to assess potential 

risks from the air and water pathways 

for several of the first 10 chemicals, 

including this chemical. For methylene 

chloride the exposure pathways that 

were or could be regulated under 

another EPA administered statute were 

excluded from the final risk evaluation 

(see section 1.4.2 of the June 2020 

methylene chloride risk evaluation). 

This resulted in the surface water, 

drinking water, ambient air, and 

sediment pathways for methylene 

chloride not being assessed for human 

health exposures or the general 

population. The goal of the recentlydeveloped screening approach is to 

remedy this exclusion and to identify if 

there are risks that were unaccounted 

for in the methylene chloride risk 

evaluation. While this analysis is 

underway, EPA is not incorporating the 

screening-level approach into this draft 

revised unreasonable risk 

determination. If the results suggest 

there is additional risk, EPA will 

determine if the risk management 

approaches being contemplated for 

methylene chloride will protect against 

these risks or if the risk evaluation will 

need to be formally supplemented or 

revised. 

This action pertains only to the risk 

determination for methylene chloride. 

While EPA intends to consider and may 

take additional similar actions on other 

of the first ten chemicals, EPA is taking 

a chemical-specific approach to 

reviewing the risk evaluations and is 

incorporating new policy direction in a 

surgical manner, while being mindful of 

the Congressional direction on the need 

to complete risk evaluations and move 

toward any associated risk management 

activities in accordance with statutory 

deadlines. 

B. What is a whole chemical view of the 

unreasonable risk determination for the 

methylene chloride risk evaluation? 

TSCA section 6 repeatedly refers to 

determining whether a chemical 

substance presents unreasonable risk 

under its conditions of use. 

Stakeholders have disagreed over 

whether a chemical substance should 

receive: A single determination that is 

comprehensive for the chemical 

substance after considering the 

conditions of use, referred to as a wholechemical determination; or multiple 

determinations, each of which is 

specific to a condition of use, referred 

to as condition-of-use-specific 

determinations. 

The proposed risk evaluation 

procedural rule was premised on the 

whole chemical approach to making an 

unreasonable risk determination (Ref. 

8). In that proposed rule, EPA 

acknowledged a lack of specificity in 

statutory text that might lead to different 

views about whether the statute 

compelled EPA’s risk evaluations to 

address all conditions of use of a 

chemical substance or whether EPA had 

discretion to evaluate some subset of 

conditions of use (i.e., to scope out some 

manufacturing, processing, distribution 

in commerce, use, or disposal 

activities), but also stated that ‘‘EPA 

believes the word ‘the’ (in TSCA section 

6(b)(4)(A)) is best interpreted as calling 

for evaluation that considers all 

conditions of use.’’ (Ref. 8). 

The proposed rule, however, was 

unambiguous on the point that an 

unreasonable risk determination would 

be for the chemical substance as a 

whole, even if based on a subset of uses. 

(See Ref. 8 at pgs. 7565–66: ‘‘TSCA 

section 6(b)(4)(A) specifies that a risk 

evaluation must determine whether ‘a 

chemical substance’ presents an 

unreasonable risk of injury to health or 

the environment ‘under the conditions 

of use.’ The evaluation is on the 

chemical substance—not individual 

conditions of use—and it must be based 

on ‘the conditions of use.’ In this 

context, EPA believes the word ‘the’ is 

best interpreted as calling for evaluation 

that considers all conditions of use.’’). 

In the proposed regulatory text, EPA 

proposed to determine whether the 

chemical substance presents an 

unreasonable risk of injury to health or 

the environment under the conditions of 

use (Ref. 8 at pg. 7480). 

The final risk evaluation procedural 

rule (Ref. 9) stated: ‘‘As part of the risk 

evaluation, EPA will determine whether 

the chemical substance presents an 

unreasonable risk of injury to health or 

the environment under each condition 

of uses [sic] within the scope of the risk 

evaluation, either in a single decision 

document or in multiple decision 

documents.’’ (See also 40 CFR 702.47). 

For the unreasonable risk 

determinations in the first ten risk 

evaluations, EPA applied this provision 

by making individual risk 

determinations for each condition of use 

evaluated in each risk evaluation (i.e., 

the condition-of-use-specific approach 

to risk determinations). That approach 

was based on one particular passage in 

the preamble to the final risk evaluation 

procedural rule, which stated that EPA 

will make individual risk 


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determinations for all conditions of use 

identified in the scope. (Ref. 9 at pg. 

33744). 

In contrast to this portion of the 

preamble of the final risk evaluation 

procedural rule, the regulatory text itself 

and other statements in the preamble 

reference a risk determination for the 

chemical substance under its conditions 

of use, rather than separate risk 

determinations for each of the 

conditions of use of a chemical 

substance. In the key regulatory 

provision excerpted earlier from 40 CFR 

702.47, the text explains that ‘‘[a]s part 

of the risk evaluation, EPA will 

determine whether the chemical 

substance presents an unreasonable risk 

of injury to health or the environment 

under each condition of uses [sic] 

within the scope of the risk evaluation, 

either in a single decision document or 

in multiple decision documents’’ (Ref. 

9, emphasis added). Other language 

reiterates this perspective. For example, 

40 CFR 702.31(a) states that the purpose 

of the rule is to establish the EPA 

process for conducting a risk evaluation 

to determine whether a chemical 

substance presents an unreasonable risk 

of injury to health or the environment 

as required under TSCA section 

6(b)(4)(B). Likewise, there are recurring 

references to whether the chemical 

substance presents an unreasonable risk 

in 40 CFR 702.41(a). See, for example, 

40 CFR 702.41(a)(6), which explains 

that the extent to which EPA will refine 

its evaluations for one or more 

condition of use in any risk evaluation 

will vary as necessary to determine 

whether a chemical substance presents 

an unreasonable risk. Notwithstanding 

the one preambular statement about 

condition-of-use-specific risk 

determinations, the preamble to the 

final rule also contains support for a risk 

determination on the chemical 

substance as a whole. In discussing the 

identification of the conditions of use of 

a chemical substance, the preamble 

notes that this task inevitably involves 

the exercise of discretion on EPA’s part, 

and ‘‘as EPA interprets the statute, the 

Agency is to exercise that discretion 

consistent with the objective of 

conducting a technically sound, 

manageable evaluation to determine 

whether a chemical substance—not just 

individual uses or activities—presents 

an unreasonable risk.’’ (Ref. 8 at pg. 

33729). 

Therefore, notwithstanding EPA’s 

choice to issue condition-of-use-specific 

risk determinations to date, EPA 

interprets its risk evaluation regulation 

to also allow the Agency to issue wholechemical risk determinations. Either 

approach is permissible under the 

regulation. A panel of the Ninth Circuit 

Court of Appeals also recognized the 

ambiguity of the regulation on this 

point. Safer Chemicals v. EPA, 943 F.3d 

397, 413 (9th Cir. 2019) (holding a 

challenge about ‘‘use-by-use risk 

evaluations [was] not justiciable because 

it is not clear, due to the ambiguous text 

of the Risk Evaluation Rule, whether the 

Agency will actually conduct risk 

evaluations in the manner Petitioners 

fear’’). 

EPA plans to consider the appropriate 

approach for each chemical substance 

risk evaluation on a case-by-case basis, 

taking into account considerations 

relevant to the specific chemical 

substance in light of the Agency’s 

obligations under TSCA. The Agency 

expects that this case-by-case approach 

will provide greater flexibility in the 

Agency’s ability to evaluate and manage 

unreasonable risk from individual 

chemical substances. EPA believes this 

is a reasonable approach under TSCA 

and the Agency’s implementing 

regulations. 

With regard to the specific 

circumstances of methylene chloride, as 

further explained in this notice, EPA 

proposes that a whole chemical 

approach is appropriate for methylene 

chloride in order to protect health and 

the environment. The whole chemical 

approach is appropriate for methylene 

chloride because there are benchmark 

exceedances for multiple conditions of 

use (spanning across most aspects of the 

chemical lifecycle—from manufacturing 

(including import), processing, 

commercial and industrial use, 

consumer use, and disposal) for health 

of workers, occupational non-users, 

consumers, and bystanders, and the 

irreversible health effects (specifically 

cancer, coma, hypoxia, and death) 

associated with methylene chloride 

exposures. Because these chemicalspecific properties cut across the 

conditions of use within the scope of 

the risk evaluation, a substantial amount 

of the conditions of use drive the 

unreasonable risk; therefore, it is 

appropriate for the Agency to make a 

determination for methylene chloride 

that the whole chemical presents an 

unreasonable risk. 

As explained later in this document, 

the revisions to the unreasonable risk 

determination (section 5 of the risk 

evaluation) would be based on the 

existing risk characterization section of 

the risk evaluation (section 4 of the risk 

evaluation) and would not involve 

additional technical or scientific 

analysis. The discussion of the issues 

presented in this Federal Register 

notice and in the accompanying draft 

revision to the risk determination would 

supersede any conflicting statements in 

the prior methylene chloride risk 

evaluation and the response to 

comments document (Ref. 10). With 

respect to the methylene chloride risk 

evaluation, EPA intends to change the 

risk determination to a whole chemical 

approach without considering the use of 

PPE and does not intend to amend, nor 

does a whole chemical approach require 

amending, the underlying scientific 

analysis of the risk evaluation in the risk 

characterization section of the risk 

evaluation. EPA views the peer 

reviewed hazard and exposure 

assessments and associated risk 

characterization as robust and 

upholding the standards of best 

available science and weight of the 

scientific evidence per TSCA sections 

26(h) and (i). 

EPA is announcing the availability of 

and seeking public comment on the 

draft superseding unreasonable risk 

determination for methylene chloride, 

including a description of the risks 

driving the unreasonable risk 

determination under the conditions of 

use for the chemical substance as a 

whole. For purposes of TSCA section 

6(i), EPA is making a draft risk 

determination on methylene chloride as 

a whole chemical. Under the proposed 

revised approach, the ‘‘whole chemical 

risk determination for methylene 

chloride would supersede the no 

unreasonable risk determinations for 

methylene chloride that were premised 

on a condition-of-use-specific approach 

to determining unreasonable risk. When 

finalized, EPA’s revised unreasonable 

risk determination would also contain 

an order withdrawing the TSCA section 

6(i)(1) order in section 5.4.1 of the June 

2020 methylene chloride risk 

evaluation. The draft revision to the risk 

determination would clarify that EPA 

does not rely on the assumed use of PPE 

when making the risk determination for 

the whole substance. EPA is requesting 

comment on this potential change. 

C. What revision does EPA propose 

about the use of PPE for the methylene 

chloride risk evaluation? 

In the risk evaluations for the first ten 

chemical substances, as part of the 

unreasonable risk determination, EPA 

assumed for several conditions of use 

that all workers were provided and 

always used PPE in a manner that 

achieves the stated assigned protection 

factor (APF) for respiratory protection or 

used impervious gloves for dermal 

protection. In support of this 

assumption, EPA considered reasonably 

available information such as public 

comments indicating that some 

employers, particularly in the industrial 


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setting, provide PPE to their employees 

and follow established worker 

protection standards (e.g., Occupational 

Safety and Health Administration 

(OSHA) requirements for protection of 

workers, specifically the existing OSHA 

standard for methylene chloride at 29 

CFR 1910.1052). 

For the June 2020 methylene chloride 

risk evaluation, EPA assumed based on 

reasonably available information, 

including public comment and safety 

data sheets, for methylene chloride that 

workers use PPE—specifically, 

respirators with an APF 25 to 50—for 26 

occupational conditions of use and 

gloves with PF 10 or 20 for 39 

occupational conditions of use. 

However, in the June 2020 methylene 

chloride risk evaluation, EPA 

determined that there was unreasonable 

risk to workers for 32 of those 

conditions of use. Overall, EPA 

determined that 36 of the 41 

occupational COUs present 

unreasonable risks to workers or 

occupational non-users. 

EPA is revising the assumption for 

methylene chloride that workers always 

or properly use PPE, although it does 

not question the information received 

regarding the occupational safety 

practices often followed by industry 

respondents, including as part of 

compliance with the OSHA methylene 

chloride standard. Notwithstanding that 

standard, when characterizing the risk 

to human health from occupational 

exposures during risk evaluation under 

TSCA, EPA believes it is appropriate to 

evaluate the levels of risk present in 

baseline scenarios where PPE is not 

assumed to be used by workers. This 

approach of not assuming PPE use by 

workers considers the risk to potentially 

exposed or susceptible subpopulations 

(workers and occupational non-users) 

who may not be covered by OSHA 

standards, such as self-employed 

individuals and public sector workers 

who are not covered by a State Plan. It 

should be noted that, in some cases, 

baseline conditions may reflect certain 

mitigation measures, such as 

engineering controls, in instances where 

exposure estimates are based on 

monitoring data at facilities that have 

engineering controls in place. 

In addition, EPA believes it is 

appropriate to evaluate the levels of risk 

present in scenarios considering 

applicable OSHA requirements (e.g., 

chemical-specific permissible exposure 

limits (PELs) and/or chemical-specific 

PELs with additional substance-specific 

standards) as well as scenarios 

considering industry or sector best 

practices for industrial hygiene that are 

clearly articulated to the Agency. 

Consistent with this approach, the June 

2020 methylene chloride risk evaluation 

characterized risk to workers both with 

and without the use of PPE. By 

characterizing risks using scenarios that 

reflect different levels of mitigation, 

EPA risk evaluations can help inform 

potential risk management actions by 

providing information that could be 

used during risk management to tailor 

risk mitigation appropriately to address 

any unreasonable risk identified, or to 

ensure that applicable OSHA 

requirements or industry or sector best 

practices that address the unreasonable 

risk are required for all potentially 

exposed or susceptible subpopulations 

(including self-employed individuals 

and public sector workers who are not 

covered by an OSHA State Plan). 

When undertaking unreasonable risk 

determinations as part of TSCA risk 

evaluations, however, EPA does not 

believe it is appropriate to assume as a 

general matter that an applicable OSHA 

requirement or industry practices 

related to PPE use is consistently and 

always properly applied. Mitigation 

scenarios included in the EPA risk 

evaluation (e.g., scenarios considering 

use of various PPE) likely represent 

what is happening already in some 

facilities. However, the Agency cannot 

assume that all facilities have adopted 

these practices for the purposes of 

making the TSCA risk determination. 

Therefore, EPA proposes to make its 

determination of unreasonable risk for 

methylene chloride from a baseline 

scenario that does not assume 

compliance with OSHA standards, 

including any applicable exposure 

limits or requirements for use of 

respiratory protection or other PPE. 

Making unreasonable risk 

determinations based on the baseline 

scenario should not be viewed as an 

indication that EPA believes there are 

no occupational safety protections in 

place at any location, or that there is 

widespread non-compliance with 

applicable OSHA standards. Rather, it 

reflects EPA’s recognition that 

unreasonable risk may exist for 

subpopulations of workers that may be 

highly exposed because they are not 

covered by OSHA standards, such as 

self-employed individuals and public 

sector workers who are not covered by 

a State Plan, or because their employer 

is out of compliance with OSHA 

standards, or because many of OSHA’s 

chemical-specific permissible exposure 

limits largely adopted in the 1970’s are 

described by OSHA as being ‘‘outdated 

and inadequate for ensuring protection 

of worker health,’’ (Ref. 11) or because 

the OSHA Permissible Exposure Limit 

alone may be inadequate to protect 

worker health, or because EPA finds 

unreasonable risk for purposes of TSCA 

notwithstanding OSHA requirements. 

In accordance with this approach, 

EPA is proposing the draft revision to 

the methylene chloride risk 

determination without relying on 

assumptions regarding the occupational 

use of PPE in making the unreasonable 

risk determination under TSCA section 

6; rather, information on the use of PPE 

as a means of mitigating risk (including 

information received from industry 

respondents about occupational safety 

practices in use) would be considered 

during the risk management phase as 

appropriate. This would represent a 

change from the approach taken in the 

2020 risk evaluation for methylene 

chloride and EPA invites comments on 

this draft change to the methylene 

chloride risk determination. As a 

general matter, when undertaking risk 

management actions, EPA intends to 

strive for consistency with applicable 

OSHA requirements and industry best 

practices, including appropriate 

application of the hierarchy of controls, 

when those measures would address an 

identified unreasonable risk including 

unreasonable risk to potentially exposed 

or susceptible subpopulations. 

Consistent with TSCA section 9(d), EPA 

will consult and coordinate TSCA 

activities with OSHA and other relevant 

Federal agencies for the purpose of 

achieving the maximum applicability of 

TSCA while avoiding the imposition of 

duplicative requirements. Informed by 

the mitigation scenarios and 

information gathered during the risk 

evaluation and risk management 

process, the Agency might propose rules 

that require risk management practices 

that may be already common practice in 

many or most facilities. Adopting clear, 

comprehensive regulatory standards 

will foster compliance across all 

facilities (ensuring a level playing field) 

and assure protections for all affected 

workers, especially in cases where 

current OSHA standards may not apply 

or be sufficient to address the 

unreasonable risk. 

Removing the assumptions that 

workers always and appropriately wear 

PPE in making the whole chemical risk 

determination for methylene chloride 

would add five additional conditions of 

use to the original 47 conditions of use 

that would drive EPA’s unreasonable 

risk determination for methylene 

chloride as a whole chemical. The five 

conditions of use affected by this change 

are: manufacturing (domestic 

manufacture); processing as a reactant; 

processing: recycling; industrial and 

commercial use as laboratory chemical; 

and disposal. Additionally, removing 


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Federal Register / Vol. 87, No. 127 / Tuesday, July 5, 2022 / Notices 39829 

this assumption would add inhalation 

risks to workers in addition to the 

previously identified inhalation risk to 

occupational non-users as driving the 

unreasonable risk in three conditions of 

use and would add risks to workers for 

acute and chronic non-cancer dermal 

exposures and for cancer from 

inhalation exposures as driving the 

unreasonable risk in many conditions of 

use (Ref. 2 at pg. 319 provides the risk 

estimates, and Table 5–1 in the risk 

determination (Ref. 1) provides 

information related to the unreasonable 

risk). 

D. What is methylene chloride? 

Methylene chloride, which is also 

called dichloromethane, is a volatile 

chemical that is produced and imported 

into the United States, with use 

estimated at over 260 million pounds 

per year. It is a solvent used in a variety 

of industries and applications, such as 

adhesives, paint and coating products, 

metal cleaning, chemical processing, 

and aerosols. In addition, it is used as 

a propellent, processing aid, or 

functional fluid in the manufacturing of 

other chemicals. A variety of consumer 

and commercial products use methylene 

chloride as a solvent including sealants, 

automotive products, and paint and 

coating removers. Methylene chloride is 

subject to federal and state regulations 

and reporting requirements. 

E. What conclusions did EPA reach 

about the risks of methylene chloride in 

the 2020 TSCA risk evaluation and what 

conclusions is EPA proposing to reach 

based on the whole chemical approach 

and not assuming the use of PPE? 

In the 2020 risk evaluation, EPA 

determined that methylene chloride 

presents an unreasonable risk to health 

under the following conditions of use: 

• Manufacture (import); 

• Processing into a formulation, 

mixture, or reaction product; 

• Repackaging; 

• Industrial and commercial use as 

solvent for batch vapor degreasing; 

• Industrial and commercial use as 

solvent for in-line vapor degreasing; 

• Industrial and commercial use as 

solvent for cold cleaning; 

• and commercial use as a solvent for 

aerosol spray degreasers/cleaners; 

• Industrial and commercial use in 

adhesives, sealants, and caulks; 

• Industrial and commercial use in 

paints and coatings; 

• Industrial and commercial use in 

paint and coating removers; 

• Industrial and commercial use in 

adhesive and caulk removers; 

• Industrial and commercial use as 

metal aerosol degreasers; 

• Industrial and commercial use in 

metal non-aerosol degreasers; 

• Industrial and commercial use in 

finishing products for fabric, textiles, 

and leather; 

• Industrial and commercial use in 

automotive care products (functional 

fluids for air conditioners); 

• Industrial and commercial use in 

automotive care products (interior car 

care); 

• Industrial and commercial use in 

automotive care products (degreasers); 

• Industrial and commercial use in 

apparel and footwear care products; 

• Industrial and commercial use in 

spot removers for apparel and textiles; 

• Industrial and commercial use in 

liquid lubricants and greases; 

• Industrial and commercial use in 

spray lubricants and greases; 

• Industrial and commercial use in 

aerosol degreasers and cleaners; 

• Industrial and commercial use in 

non-aerosol degreasers and cleaners; 

• Industrial and commercial use in 

cold pipe insulations; 

• Industrial and commercial use as 

solvent that becomes part of a 

formulation or mixture; 

• Industrial and commercial use as a 

processing aid; 

• Industrial and commercial use as 

propellant and blowing agent; 

• Industrial and commercial use for 

electrical equipment, appliance, and 

component manufacturing; 

• Industrial and commercial use for 

plastic and rubber products 

manufacturing; 

• Industrial and commercial use for 

cellulose triacetate film production; 

• Industrial and commercial use as 

anti-spatter welding aerosol; 

• Industrial and commercial use for 

oil and gas drilling, extraction, and 

support activities; 

• Industrial and commercial uses for 

toys, playgrounds, and sporting 

equipments (including novelty articles); 

• Industrial and commercial use for 

carbon removers, wood floor cleaners, 

and brush cleaners; 

• Industrial and commercial use as a 

lithographic printing plate cleaner; 

• Consumer use as a solvent in an 

aerosol cleaner/degreaser; 

• Consumer use in adhesives and 

sealants; 

• Consumer use in paints and 

coatings (brush cleaners for paints and 

coatings); 

• Consumer use in adhesives/caulk 

removers; 

• Consumer use in aerosol and nonaerosol metal degreasers; 

• Consumer use in automotive 

functional fluids (air conditioners 

refrigerant, treatment, leak sealer); 

• Consumer use in automotive 

degreasers (gasket remover, 

transmission cleaners, carburetor); 

• Consumer use in aerosol and nonaerosol lubricants and greases, 

consumer use in cold pipe insulation; 

• Consumer use in aerosol and nonaerosol lubricants/greases and aerosol 

and non-aerosol degreaser/cleaners; 

• Consumer use in cold pipe 

insulation; 

• Consumer use in crafting glue and 

cement/concrete; 

• Consumer use in anti-adhesive 

agent—anti-spatter welding aerosol; and 

• Consumer use in carbon remover 

and brush cleaner. 

Under the proposed whole chemical 

approach to the methylene chloride risk 

determination, the unreasonable risk 

from methylene chloride would 

continue to be driven by risk from those 

same condition of use. In addition, by 

removing the assumption of PPE use in 

making the whole chemical risk 

determination for methylene chloride, 

five conditions of use in addition to the 

original 47 would drive the draft 

unreasonable risk determination: 

• Manufacturing (domestic 

manufacture); 

• Processing as a reactant; 

• Processing: recycling; 

• Industrial and commercial use as 

laboratory chemical; and 

• Disposal. 

Overall, 52 conditions of use out of 

the 53 EPA evaluated would drive the 

methylene chloride whole chemical 

unreasonable risk determination. 

III. Revision of the June 2020 Risk 

Evaluation 

A. Why is EPA proposing to revise the 

risk determination for the methylene 

chloride risk evaluation? 

EPA is proposing to revise the risk 

determination for the methylene 

chloride risk evaluation pursuant to 

TSCA section 6(b) and consistent with 

Executive Order 13990, (‘‘Protecting 

Public Health and the Environment and 

Restoring Science to Tackle the Climate 

Crisis’’) and other Administration 

priorities (Refs. 3, 4, and 6). EPA is 

revising specific aspects of the first ten 

TSCA existing chemical risk evaluations 

in order to ensure that the risk 

evaluations better align with TSCA’s 

objective of protecting health and the 

environment. For the methylene 

chloride risk evaluation, this includes 

the draft revision: (1) making the risk 

determination in this instance based on 

the whole chemical substance instead of 

by individual conditions of use, and (2) 

emphasizing that EPA does not rely on 

the assumed use of PPE when making 

the risk determination. 


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39830 Federal Register / Vol. 87, No. 127 / Tuesday, July 5, 2022 / Notices 

B. What are the draft revisions? 

EPA is releasing a draft revision of the 

risk determination for the methylene 

chloride risk evaluation pursuant to 

TSCA section 6(b). Under the draft 

revised determination, EPA 

preliminarily concludes that methylene 

chloride, as evaluated in the risk 

evaluation as a whole, presents an 

unreasonable risk of injury to health 

under its conditions of use. This 

revision would replace the previous 

unreasonable risk determinations made 

for methylene chloride by individual 

conditions of use, supersede the 

determinations (and withdraw the 

associated order) of no unreasonable 

risk for the conditions of use identified 

in the TSCA section 6(i)(1) no 

unreasonable risk order, and clarify the 

lack of reliance on assumed use of PPE 

as part of the risk determination. 

These draft revisions do not alter any 

of the underlying technical or scientific 

information that informs the risk 

characterization, and as such the 

hazard, exposure, and risk 

characterization sections are not 

changed except to the extent that 

statements about PPE assumptions in 

section 2.4.1.1 (Consideration of 

Engineering Controls and PPE) of the 

methylene chloride risk evaluation 

would be superseded. The discussion of 

the issues in this notice and in the 

accompanying draft revision to the risk 

determination would supersede any 

conflicting statements in the prior 

executive summary and section 2.4.1.1 

from the methylene chloride risk 

evaluation and the response to 

comments document (Refs. 2 and 10). 

Additional policy changes to other 

chemical risk evaluations, including any 

consideration of potentially exposed or 

susceptible subpopulations and/or 

inclusion of additional exposure 

pathways, are not necessarily reflected 

in these draft revisions to the risk 

determination. 

C. Will the draft revised risk 

determination be peer reviewed? 

The risk determination (section 5 in 

the June 2020 risk evaluation) was not 

part of the scope of the peer reviews of 

the methylene chloride risk evaluation 

by the Science Advisory Committee on 

Chemicals (SACC). Thus, consistent 

with that approach, EPA does not 

intend to conduct peer review for the 

draft revised unreasonable risk 

determination of the methylene chloride 

risk evaluation because no technical or 

scientific changes will be made to the 

hazard or exposure assessments or the 

risk characterization. 

D. What are the next steps for finalizing 

revisions to the risk determination? 

EPA will review and consider public 

comment received on the draft revised 

risk determination for the methylene 

chloride risk evaluation and, after 

considering those public comments, 

issue the revised final methylene 

chloride risk determination. If finalized 

as drafted, EPA would also issue a new 

order to withdraw the TSCA section 

6(i)(1) no unreasonable risk order issued 

in Section 5.4.1 of the 2020 methylene 

chloride risk evaluation. This final 

revised risk determination would 

supersede the June 2020 risk 

determinations of no unreasonable risk. 

Consistent with the statutory 

requirements of TSCA section 6(a), the 

Agency would then propose risk 

management actions to address the 

unreasonable risk determined in the 

methylene chloride risk evaluation. 

IV. References 

The following is a listing of the 

documents that are specifically 

referenced in this document. The docket 

includes these documents and other 

information considered by EPA, 

including documents that are 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. EPA. Draft Revised Unreasonable Risk 

Determination for methylene chloride, 

Section 5, July 2022. 

2. EPA. Risk Evaluation for Methylene 

Chloride (MC). EPA Document #740–R1– 

8010. January 2021. https://

www.regulations.gov/document/EPAHQ-OPPT-2019-0437-0107. 

3. Executive Order 13990. Protecting Public 

Health and the Environment and 

Restoring Science to Tackle the Climate 

Crisis. Federal Register. 86 FR 7037, 

January 25, 2021. 

4. Executive Order 13985. Advancing Racial 

Equity and Support for Underserved 

Communities Through the Federal 

Government. Federal Register. 86 FR 

7009, January 25, 2021. 

5. Executive Order 14008. Tackling the 

Climate Crisis at Home and Abroad. 

Federal Register. 86 FR 7619, February 

1, 2021. 

6. Presidential Memorandum. Memorandum 

on Restoring Trust in Government 

Through Scientific Integrity and 

Evidence-Based Policymaking. Federal 

Register. 86 FR 8845, February 10, 2021. 

7. EPA Press Release. EPA Announces Path 

Forward for TSCA Chemical Risk 

Evaluations. June 2021. https://

www.epa.gov/newsreleases/epaannounces-path-forward-tsca-chemicalrisk-evaluations. 

8. EPA. Proposed Rule; Procedures for 

Chemical Risk Evaluation Under the 

Amended Toxic Substances Control Act. 

Federal Register. 82 FR 7562, January 

19, 2017 (FRL–9957–75). 

9. EPA. Final Rule; Procedures for Chemical 

Risk Evaluation Under the Amended 

Toxic Substances Control Act. Federal 

Register. 82 FR 33726, July 20, 2017 

(FRL–9964–38). 

10. EPA. Summary of External Peer Review 

and Public Comments and Disposition 

for Methylene Chloride (MC); Response 

to Support Risk Evaluation of Methylene 

Chloride (MC). EPA Document# EPA– 

740–R2–0022. June 2020. https://

www.regulations.gov/document/EPAHQ-OPPT-2019-0437-0083. 

11. Occupational Safety and Health 

Administration. Permissible Exposure 

Limits—Annotated Tables. Accessed 

June 13, 2022. https://www.osha.gov/ 

annotated-pels. 

Authority: 15 U.S.C. 2601 et seq. 

Dated: June 28, 2022. 

Michal Freedhoff, 

Assistant Administrator, Office of Chemical 

Safety and Pollution Prevention. 

[FR Doc. 2022–14163 Filed 7–1–22; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

[EPA–HQ–OLEM–2018–0317; FRL–9905– 

01–OLEM] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Criteria for 

Classification of Solid Waste Disposal 

Facilities and Practices (Renewal), EPA 

ICR No. 1745.10, OMB Control No. 

2050–0154 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Notice. 

SUMMARY: The Environmental Protection 

Agency (EPA) is planning to submit the 

information collection request (ICR), 

Criteria for Classification of Solid Waste 

Disposal Facilities and Practices, 

Recordkeeping and Reporting 

Requirements (EPA ICR No. 1745.10, 

OMB Control No. 2050–0154) to the 

Office of Management and Budget 

(OMB) for review and approval in 

accordance with the Paperwork 

Reduction Act (PRA). Before doing so, 

the EPA is soliciting public comments 

on specific aspects of the proposed 

information collection as described in 

SUPPLEMENTARY INFORMATION. This is a 

proposed extension of the ICR, which is 

currently approved through February 

28, 2023. An Agency may not conduct 

or sponsor and a person is not required 

to respond to a collection of information 


lotter on DSK11XQN23PROD with NOTICES1