
[Federal Register Volume 84, Number 59 (Wednesday, March 27, 2019)]
[Rules and Regulations]
[Pages 11420-11436]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-05666]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 751

[EPA-HQ-OPPT-2016-0231; FRL-9989-29]
RIN 2070-AK07


Methylene Chloride; Regulation of Paint and Coating Removal for 
Consumer Use Under TSCA Section 6(a)

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: Methylene chloride, also called dichloromethane, is a volatile 
chemical used in paint and coating removal products. In this final 
rule, EPA has determined that the use of methylene chloride in consumer 
paint and coating removal presents an unreasonable risk of injury to 
health due to acute human lethality. In order to address the 
unreasonable risk, EPA is prohibiting the manufacture (including 
import), processing, and distribution in commerce of methylene chloride 
for consumer paint and coating removal, including distribution to and 
by retailers; requiring manufacturers (including importers), 
processors, and distributors, except for retailers, of methylene 
chloride for any use to provide downstream notification of these 
prohibitions; and requiring recordkeeping. While EPA proposed a 
determination of unreasonable risk from the use of methylene chloride 
in commercial paint and coating removal, EPA is not finalizing that 
determination in this rule. EPA is soliciting comment, through an 
advance notice of proposed rulemaking (ANPRM) published elsewhere in 
this issue of the Federal Register, on questions related to a potential 
training, certification, and limited access program as an option for 
risk management for all of the commercial uses of methylene chloride in 
paint and coating removal.

DATES: This final rule is effective May 28, 2019.

ADDRESSES: The docket for this action, identified by docket 
identification (ID) number EPA-HQ-OPPT-2016-0231, is available at 
http://www.regulations.gov. A public version of the docket is available 
for inspection and copying between 8:30 a.m. and 4:30 p.m., Monday 
through Friday, excluding Federal holidays, at the U.S. Environmental 
Protection Agency, EPA Docket Center Reading Room, WJC West Building, 
Room 3334, 1301 Constitution Avenue NW, Washington, DC 20004. A 
reasonable fee may be charged for copying.

FOR FURTHER INFORMATION CONTACT: 
    For technical information contact: Joel Wolf, Chemical Control 
Division, Office of Pollution Prevention and Toxics, Environmental 
Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-
0001; telephone number: (202) 564-0432; email address: 
MCConsumerPR@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: 

I. Executive Summary

A. Does this action apply to me?

    You may potentially be affected by this final action if you 
manufacture (including import), process, or distribute in commerce 
methylene chloride (CASRN 75-09-2). 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:

 Chemical and Allied Products Manufacturers (NAICS code 32411)
 Chemical and Allied Products and Merchants Wholesalers (NAICS 
code 4246)
 Building Materials and Supplies Dealers (NAICS code 4441)

    This action may also affect certain entities through pre-existing 
import certification and export notification rules under TSCA. Persons 
who import

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any chemical substance governed by a final TSCA section 6 rule are 
subject to the TSCA section 13 (15 U.S.C. 2612) import certification 
requirements and the corresponding regulations at 19 CFR 12.118 through 
12.127; see also 19 CFR 127.28. Those persons must certify that a 
shipment of the chemical substance (in this case, methylene chloride) 
complies with all applicable rules and orders under TSCA. The EPA 
policy in support of import certification appears at 40 CFR part 707, 
subpart B. In addition, any persons who export or intend to export a 
chemical substance subject to regulation under section 6 (in this case, 
methylene chloride) are subject to the export notification provisions 
of TSCA section 12(b) (15 U.S.C. 2611(b)), and must comply with the 
export notification requirements in 40 CFR part 707, subpart D.
    If you have any questions regarding the applicability of this final 
action to a particular entity, consult the technical information 
contact listed under FOR FURTHER INFORMATION CONTACT.

B. What is the Agency's authority for taking this action?

    Under TSCA section 6(a) (15 U.S.C. 2605(a)), if EPA determines that 
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 identified as relevant, under the conditions 
of use, EPA must by rule apply one or more requirements to the extent 
necessary so that the chemical substance or mixture no longer presents 
such risk.
    With respect to a chemical substance listed in the 2014 update to 
the TSCA Work Plan for Chemical Assessments for which a completed risk 
assessment was published prior to the date of enactment of the Frank R. 
Lautenberg Chemical Safety for the 21st Century Act, TSCA section 
26(l)(4) (15 U.S.C. 2625(l)(4)) provides that EPA ``may publish 
proposed and final rules under [TSCA section 6(a)] that are consistent 
with the scope of the completed risk assessment and consistent with 
other applicable requirements of [TSCA section 6].'' Methylene chloride 
is such a chemical substance. It is listed in the 2014 update to the 
TSCA Work Plan and the 2014 final risk assessment includes consumer 
uses of paint and coating removal, among other uses (Refs. 1 and 2). 
EPA is publishing this final rule under TSCA section 6(a) in accordance 
with that discretionary statutory authority.

C. What action is the Agency taking?

    EPA is making a final determination that the use of methylene 
chloride in consumer paint and coating removal presents an unreasonable 
risk of injury to health due to acute human lethality. Accordingly, EPA 
is issuing a final rule under section 6(a) of TSCA to prohibit the 
manufacture (including import), processing, and distribution in 
commerce of methylene chloride for consumer paint and coating removal 
(including distribution to and by retailers). This final rule also 
requires manufacturers (including importers), processors, and 
distributors, except for retailers, of methylene chloride for any use 
to provide downstream notification of the prohibitions throughout the 
supply chain; and requires limited recordkeeping. More details on these 
requirements are in Unit III.B.
    In the proposed rule for methylene chloride in paint and coating 
removal (Ref. 3), EPA proposed an unreasonable risk determination for 
methylene chloride in commercial paint removal uses. In addition, EPA 
proposed to regulate under TSCA section 6(a) manufacture (including 
import), processing, distribution in commerce and use of methylene 
chloride in paint and coating removal for certain commercial uses. As 
noted previously, exercising its discretion under section 26(l)(4), EPA 
is not finalizing the proposed unreasonable risk determination and the 
proposed regulation for commercial uses of methylene chloride in paint 
and coating removal in this final action. Rather, EPA is soliciting 
comment, through an ANPRM published elsewhere in this issue of the 
Federal Register, on questions related to a potential training, 
certification, and limited access program as an option for risk 
management for all of the commercial uses of methylene chloride in 
paint and coating removal. More details on the proposed rule are in 
Unit II.B.2.
    In the proposed rule for methylene chloride in paint and coating 
removal, EPA also proposed to regulate under TSCA section 6(a) N-
methylpyrrolidone (NMP) in paint and coating removal. EPA is not 
finalizing the proposed regulation for NMP as part of this action. NMP 
use in paint and coating removal will be incorporated into the risk 
evaluation currently being conducted under TSCA section 6(b). More 
information about the proposed rule and NMP is in Unit II.B.2.

D. Why is the Agency taking this action?

    Based on EPA's analysis of consumer exposures to methylene chloride 
in paint and coating removal, EPA is making a final determination that 
the use of methylene chloride in consumer paint and coating removal 
presents an unreasonable risk of injury to health due to acute human 
lethality. This final rule addresses the unreasonable risk, which may 
include death due to asphyxiation, in a manner that results in the 
chemical no longer presenting that unreasonable risk. Effects from 
acute exposure during use of methylene chloride in paint and coating 
removal may include neurological impacts such as dizziness, 
incapacitation, loss of consciousness, coma, and death (Ref. 2).
    As noted in Unit III.A., EPA is regulating certain conditions of 
use of methylene chloride related to consumer paint and coating 
removal, which is estimated to comprise less than 10% of the total use 
of the chemical (Ref. 4).

E. What are the estimated impacts of this action?

    As described in more detail in the Economic Analysis (Ref. 4), 
EPA's analysis of the cost of this rule is estimated to be $3.8 to 
$13.6 million annualized over 20 years at a 3% discount rate and $3.8 
to $13.7 million annualized over 20 years at a 7% discount rate. 
Because the costs estimated in this rule are variable, the values at 
the different discount rates are similar. Unquantified costs include 
potential loss of producer and consumer surplus associated with 
possible reductions in paint and coating removal activity. There may 
also be unquantified costs associated with performance of alternatives 
including longer time for products to work and countervailing hazards 
from alternative chemicals including potentially higher flammability 
and exposure to other toxic chemicals.
    Preventing exposure to methylene chloride in consumer paint and 
coating removal results in monetized benefits, as well as non-monetized 
benefits. Monetized benefits include the prevention of deaths resulting 
from acute adverse effects that occur at a known rate among consumer 
users. Non-monetized benefits result from the prevention of some non-
cancer adverse effects to the nervous system. Thus, there is not a 
quantification or monetary valuation estimate for the overall total 
benefits. Based on the benefits that EPA can monetize, the benefits for 
this rule are approximately $3.5 million per year over 20 years at 3% 
and 7% discount rate (Ref. 4).

F. Children's Environmental Health

    This action is consistent with the 1995 EPA Policy on Evaluating 
Health

[[Page 11422]]

Risks to Children (http://www.epa.gov/children/epas-policy-evaluating-risk-children). In its TSCA Work Plan Risk Assessment for methylene 
chloride, EPA identified risks from inhalation exposure to children who 
may be present as bystanders in homes where consumer paint and coating 
removal occurs. These risks may include neurological effects such as 
cognitive impairment, sensory impairment, dizziness, incapacitation, 
and loss of consciousness (leading to risks of falls, concussion, and 
other injuries). Supporting information on the health effects of 
methylene chloride exposure to children is available in the 
Toxicological Review of Methylene Chloride (Ref. 5) and the Final Risk 
Assessment on Methylene Chloride (Ref. 2), as well as Unit II.A.

II. Background

A. Methylene Chloride, Health Effects, Risks, and Other Regulatory 
Actions

    Methylene chloride (CASRN 75-09-2) is a solvent used in a variety 
of industrial, commercial and consumer use applications, including 
adhesives, pharmaceuticals, metal cleaning, chemical processing, and 
feedstock in the production of refrigerant hydrofluorocarbon-32 (Ref. 
2). According to the 2016 Chemical Data Reporting (CDR) information, 
approximately 264 million pounds of methylene chloride were 
domestically manufactured or imported into the United States in 2015, 
with the bulk of the volume domestically manufactured (Ref. 6). Most 
methylene chloride is produced and used for purposes other than paint 
and coating removal, which represents less than 10% of total use of 
methylene chloride (Ref. 4). In terms of environmental releases, 271 
facilities reported a total of 3.4 million pounds of releases of 
methylene chloride to the 2015 Toxics Release Inventory (Ref. 7). 
Individuals are exposed to methylene chloride from industrial/
commercial and consumer sources in different settings, such as homes 
and workplaces, and through multiple routes (inhalation, dermal, and 
ingestion).
    Methylene chloride is acutely lethal, a neurotoxicant, and a likely 
human carcinogen. This final rule is specifically intended to prevent 
the unreasonable risks of injury to health due to acute human lethality 
from use of methylene chloride for consumer paint and coating removal. 
The risk assessment presents a detailed description of the range of 
adverse acute and chronic health effects associated with methylene 
chloride (Ref. 2).
    The primary target organ of methylene chloride acute toxicity is 
the brain, and neurological effects result from either direct narcosis 
or the formation of carbon monoxide. The accumulation of 
carboxyhemoglobin in the blood can lead to sensory impairment, 
dizziness, incapacitation, loss of consciousness, heart failure, and 
death. The neurotoxic and cardiovascular effects may be exacerbated in 
fetuses and in infants with higher residual levels of fetal hemoglobin 
when exposed to high concentrations of methylene chloride (Ref. 2).
    Based on data from the Occupational Safety and Health 
Administration (OSHA), the Consumer Product Safety Commission (CPSC), 
state records, and publicly reported information, EPA identified 49 
fatalities from 1976 to 2016 (Ref. 3 at p. 7482) resulting from 
consumer or commercial worker exposure to methylene chloride during 
paint and coating removal. However, this may be an underestimate of the 
deaths that have occurred (Refs. 7 and 8). More details are provided in 
the proposed rule (Ref. 3 at p. 7468).
    Since the publication of the January 19, 2017, proposed rule, EPA 
has learned of four additional fatalities due to methylene chloride in 
paint and coating removal (Ref. 10). Two of the victims were 
independent contractors working for small or family-owned businesses, 
the third was a small business owner, and the fourth was a consumer who 
died while using a methylene chloride paint and coating removal product 
to remove paint (Ref. 10). Many of the victims used paint and coating 
removers easily available to consumers through retailers. This may not 
constitute an exhaustive list of fatalities, rather, those that were 
brought to the attention of the Agency since publication of the 
proposed rule.
    The use of methylene chloride in paint and coating removal presents 
an increased risk of death and nervous system effects for many of the 
estimated 1.3 million consumers and residential bystanders who use or 
are exposed to methylene chloride through consumer paint and coating 
removal each year (Ref. 4). Of particular concern is the potential for 
acute neurological impairment (central nervous system depressant 
effects) for consumers using methylene chloride for paint and coating 
removal. In the risk assessment, the upper-end scenarios for consumer 
users had 4-hour exposures of 233 parts per million (ppm). As described 
in the risk assessment, the Acute Exposure Guideline (AEGL-2), which is 
the threshold for disability for an 8-hour exposure, is 60 ppm. In 
humans, acute exposure to methylene chloride above 200 ppm results in 
acute neurobehavioral deficits measured in psychomotor tasks including: 
Tests of hand-eye coordination, visual evoked response changes, and 
auditory vigilance. In a few cases, cardiotoxic effects (i.e., 
evidenced by electrocardiogram changes) were reported in humans (Ref. 
2).
    Some populations are currently at disproportionate risk for the 
health effects associated with use of methylene chloride in paint and 
coating removal, including children present in homes where consumer 
paint and coating removal is conducted. EPA's full analysis, conducted 
as part of compliance with Executive Order 13166 (65 FR 50121, August 
11, 2000) and Executive Order 12898 (59 FR 7629, February 16, 1994) is 
described in the proposed rule (Ref. 3 at pp. 7476, 7525).
    While the primary concern has been human health, there is potential 
for methylene chloride exposures to adversely impact ecological 
receptors. Methylene chloride is mainly released to the environment in 
air, and to a lesser extent in water and soil, due to industrial/
commercial and consumer uses as a solvent, in aerosol products, and in 
paint and coating removal. Methylene chloride is moderately persistent 
and its bioaccumulation potential is low. Though volatile, methylene 
chloride has negligible atmospheric photochemical reactions, and is 
therefore exempt from being classified as a volatile organic compound 
(VOC) as defined at 40 CFR 51.100(c).
    The proposed rule presented a comprehensive overview of regulatory 
actions by EPA, other Federal agencies, and state and international 
agencies pertaining to methylene chloride use in paint and coating 
removal and actions addressing methylene chloride waste disposal, 
releases to air and contamination of groundwater, drinking water, and 
soils (Ref. 3 at p. 7469). EPA presents here a summary of those 
actions, with a focus on those that have changed since the proposed 
rule.
    EPA has issued several final rules and notices pertaining to 
methylene chloride under EPA's various authorities. Under the Clean Air 
Act, which designates methylene chloride as a hazardous air pollutant 
(HAP), EPA has promulgated several National Emissions Standards for 
Hazardous Air Pollutants (NESHAPs) addressing specific sources for 
methylene chloride emissions, including area sources engaged in paint 
stripping, surface coating of motor vehicles and mobile equipment, and 
miscellaneous surface coating

[[Page 11423]]

operations, and a 2015 update to a 1995 NESHAP for Aerospace 
Manufacturing and Rework Facilities (42 U.S.C. 7412(b)(1)) CAA). 
Methylene chloride is listed as a hazardous waste under the Resource 
Conservation and Recovery Act (RCRA) (Hazardous Waste No. U080, for 
discarded commercial products, and Waste Nos. F001, F002, for spent 
halogenated solvents including those halogenated solvents used in 
degreasing) and as a hazardous constituent in appendix VIII to 40 CFR 
part 261 (Ref. 2). The Emergency Planning and Community Right-to-Know 
Act, section 313, lists methylene chloride on the Toxics Release 
Inventory (TRI) (Ref. 2). The Safe Drinking Water Act requires EPA to 
determine the level of contaminants in drinking water at which no 
adverse health effects are likely to occur, with EPA setting a maximum 
contaminant level goal of zero and an enforceable maximum contaminant 
level for methylene chloride (dichloromethane) at 0.005 milligrams/
Liter (mg/L) or 5 parts per billion (ppb) (57 FR 31776, July 17, 1992).
    Other Federal agencies with regulations on methylene chloride 
include the Food and Drug Administration (FDA), which has banned 
methylene chloride as an ingredient in all cosmetic products (21 CFR 
700.19); OSHA, which has a permissible exposure limit (PEL) of 25 ppm 
as an eight-hour time-weighted average (TWA) and a 15-minute short-term 
exposure limit (STEL) of 125 ppm; and CPSC, which has updated its 
labeling policy for household products containing methylene chloride.
    In 2016, CPSC was petitioned by the Halogenated Solvents Industry 
Alliance to amend its guidance contained in the Statement of 
Interpretation and Enforcement Policy on the Labeling of Certain 
Household Products Containing Methylene Chloride; CPSC published that 
petition and requested public comments (81 FR 60298, September 1, 
2016). In response to that petition, CPSC updated the cautionary 
labeling policy for paint strippers containing methylene chloride to 
recommend the inclusion of language on the principal display panel of 
the label and on the back or other panel to specifically describe the 
risk of fatality from acute exposure in enclosed spaces (83 FR 12254, 
March 21, 2018; 83 FR 18219, April 26, 2018). CPSC's recommendations 
also included providing specific examples of spaces in which the 
product should not be used, incorporating precautionary information for 
indoor use, and warning against foreseeable inappropriate actions that 
are not sufficiently protective, such as use of a dust mask to provide 
protection against vapors. More information on CPSC's updates are in 
Unit III.A.4.
    Several states have taken actions to reduce or make the public 
aware of risks from methylene chloride. In November 2017, California 
EPA's Department of Toxic Substances Control (DTSC) proposed to list 
paint strippers with methylene chloride as a priority product under its 
Safer Consumer Products regulations (Ref. 11). Methylene chloride is on 
DTSC's list of candidate chemicals (Ref. 12). If finalized, 
California's regulation on methylene chloride in paint and coating 
removers would trigger notification requirements for responsible 
entities, such as manufacturers and importers to DTSC, and require 
those companies making paint strippers with methylene chloride to 
analyze alternatives to determine if methylene chloride is essential 
and whether there are available alternatives.

B. History of This Rulemaking

    This rule finalizes certain parts of the regulation proposed on 
January 19, 2017 (Ref. 3) with respect to methylene chloride use for 
consumer paint and coating removal. The proposed rule followed EPA's 
2014 final risk assessment of methylene chloride for paint and coating 
removal. The changes in this final rule from the proposal are discussed 
in Unit III.
    1. TSCA Work Plan and Methylene Chloride Risk Assessment. In 2012, 
EPA released the initial list of TSCA Work Plan chemicals identified 
for further assessment under TSCA as part of its chemical safety 
program (Ref. 1). The process for identifying these chemicals was based 
on a combination of hazard, exposure, and persistence and 
bioaccumulation characteristics, and is described in the ``TSCA Work 
Plan Chemicals: Methods Document'' (Ref. 13). Under the TSCA Work Plan 
chemical criteria, methylene chloride ranked high for health hazards 
and exposure potential. Methylene chloride also appeared in the 2014 
update of the TSCA Work Plan for Chemical Assessments.
    EPA finalized a TSCA Work Plan Chemical Risk Assessment for 
methylene chloride in paint and coating removal (methylene chloride 
risk assessment) in August 2014, following the 2013 peer review of the 
2012 draft methylene chloride risk assessment. The completed 2014 risk 
assessment and all documents from the peer review process are available 
in Docket Number EPA-HQ-OPPT-2012-0725.
    The 2014 methylene chloride risk assessment evaluated health risks 
to consumers, among others, from inhalation exposures from methylene 
chloride use in paint and coating removal. A more detailed discussion 
of the risk assessment is included in the proposed rule (Ref. 3 at p. 
7470). The risk assessment identified risks of concern following acute 
(short-term) exposures for consumers and others conducting paint 
removal with methylene chloride, as well as for exposed bystanders, 
including residents of homes in which paint removal is conducted. The 
acute risks identified include death; neurological impacts such as 
dizziness, incapacitation, loss of consciousness, and coma (Ref. 2).
    The assessment identified risks from acute exposures to methylene 
chloride when used for consumer paint and coating removal, including 
(Ref. 2):
     Acute risks of neurological effects for consumer users of 
methylene chloride as a paint remover.
     Acute risks of neurological effects for bystanders 
(including children) in the location in which paint removers containing 
methylene chloride are used by residents (i.e. consumer paint and 
coating removal). These risks are also present for exposures to 
methylene chloride in a location after the paint removal work is 
complete, because methylene chloride can remain in the air in spaces 
that are enclosed, confined, or lacking ventilation.
    Among the comments on the proposed rule, an overview of which is 
given in Unit II.B.3., EPA received 28 comments related to the 2014 
risk assessment. Twelve mass-mailing campaigns, resulting in over 
100,000 public comments, and four individual comments reiterated or 
supported the conclusions of the risk assessment. A separate individual 
comment provided a list of additional references documenting the health 
effects and deaths from methylene chloride use. Other commenters 
identified what they believe were shortcomings in the risk assessment, 
such as an underestimation of risk; lack of proper consideration of 
available data; deficiencies in risk estimation; an overestimation of 
risk; and lack of verification of data and fatality incident reports. 
Other comments included additional information from local governments 
regarding fatalities and adverse effects from use of methylene chloride 
in paint removers. There were also comments related to carcinogenicity.
    The Small Business Advocacy Review (SBAR) Panel convened in support 
of this action heard from several Small Entity Representatives (SERs) 
who expressed concerns about the underlying methylene chloride risk 
assessment (Ref. 14). Many of the

[[Page 11424]]

concerns expressed by these SERs were already expressed in the public 
comments and the peer review comments on the methylene chloride risk 
assessment. The Summary of External Peer Review and Public Comments and 
Disposition document in the risk assessment docket (EPA-HQ-OPPT-2012-
0725) explains how EPA responded to the comments received.
    EPA appreciates the comments supporting the conclusions of the risk 
assessment and those providing additional information. Some commenters 
expressed concern about analytical shortcomings in the risk assessment. 
However, the risk assessment relied on previous assessments that used 
current hazard and risk assessment methodology documented in EPA 
guidance. In particular, the hazard and dose response information in 
the risk assessment were developed by reputable organizations and 
subject to peer review processes and the cancer descriptor ``likely 
carcinogenic in humans'' is based on EPA's Toxicological Review using a 
weight of evidence approach (Ref. 5). The methylene chloride risk 
assessment was also peer reviewed. The comments on the risk assessment 
that were received during the comment periods on the proposed rule, and 
EPA's responses, are in the Response to Comments document (Ref. 15).
    2. EPA's proposed rule under TSCA Section 6(a) for methylene 
chloride. EPA proposed to prohibit the manufacture (including import), 
processing, and distribution in commerce of methylene chloride for all 
consumer and most types of commercial paint removal, and to prohibit 
most commercial use of methylene chloride for paint and coating 
removal. Exercising its discretion under section 26(l)(4), EPA is not 
finalizing the portion of the proposal relating to commercial paint and 
coating removal today. EPA will address commercial paint and coating 
removal in the future after soliciting comment, through an ANPRM 
published elsewhere in this issue of the Federal Register, on questions 
related to a potential training, certification, and limited access 
program.
    EPA proposed a determination of unreasonable risk from the use of 
NMP in paint and coating removal. However, exercising its discretion 
under section 26(l)(4), EPA is not finalizing the proposed unreasonable 
risk determination for NMP in paint and coating removal at this time. 
EPA intends to incorporate NMP use in paint and coating removal in the 
risk evaluation for NMP. EPA has concluded that the Agency's assessment 
of the potential risks from this widely used chemical will be more 
robust if the potential risks from these conditions of use are 
evaluated by applying standards and guidance under amended TSCA. In 
particular, this includes ensuring the evaluation is consistent with 
the scientific standards in Section 26 of TSCA, including using best 
available science and systematic review approaches. Additional 
information on the NMP risk evaluation process, including public 
meetings, supporting documents, and public comments, is available in 
Docket Number EPA-HQ-OPPT-2016-0743.
    In the proposed rule, EPA described supplemental analyses used to 
inform certain aspects of risk management for methylene chloride in 
paint and coating removal (Ref. 3 at p. 7472). These analyses were 
consistent with the scope of the methylene chloride risk assessment and 
were based on the peer-reviewed methodology used in the risk assessment 
(Ref. 3 at p. 7521). While EPA stated in the proposed rule that these 
analyses would be peer reviewed prior to promulgation of a final rule 
and received one comment on the proposed rule to that effect, they will 
not be peer reviewed at this time because EPA is not finalizing 
regulatory approaches informed by the results of those analyses.
    In the proposed rule for methylene chloride in paint and coating 
removal (Ref. 3), EPA proposed an unreasonable risk determination for 
commercial uses of methylene chloride in paint and coating removal, 
including commercial furniture refinishing. EPA, in collaboration with 
the Small Business Administration's Office of Advocacy, conducted a 
workshop on furniture refinishing in Boston, MA on September 12, 2017 
(82 FR 41256, August 30, 2017) (FRL-9966-83). A transcript of the 
meeting and speaker presentations are available in Docket Number EPA-
HQ-OPPT-2017-0139.
    In the proposed rule, EPA requested comment on a process for 
receiving and evaluating petitions requesting EPA to promulgate 
statutory exemptions. While EPA is not finalizing an exemption process 
in this rule, EPA will take the commenters' suggestions into account as 
EPA considers how to proceed in the future with respect to exemptions 
under TSCA section 6(g).
    3. Public comments and other public input. The proposed rule 
provided for a 90-day comment period, ending on April 19, 2017; this 
comment period was extended until May 19, 2017, in response to public 
requests (82 FR 20310, May 1, 2017) (FRL-9961-66). Even though EPA 
received requests for a lengthier extension of the comment periods, the 
Agency concluded that a 30-day extension of the initial comment period 
was sufficient.
    EPA received more than 147,000 comments on the proposed rule. 
Commenters included private citizens, potentially affected businesses, 
trade associations, environmental and public health advocacy groups, 
state and local governments, and other Federal agencies. Most of the 
comments received through mass mail campaigns and individual public 
comments supported the rule and urged EPA to prohibit the use of 
methylene chloride in paint and coating removal to stop putting 
families, workers and communities at risk, citing the lethality of 
methylene chloride and fatalities due to paint and coating removal with 
methylene chloride. Other commenters opposed the rule, and questioned 
EPA's authority for issuing it. In this preamble, EPA has responded to 
many of the comments relevant to methylene chloride in consumer paint 
and coating removal; however, the more comprehensive version of EPA's 
response to comments related to this final action can be found in the 
Response to Comments document (Ref. 15). Public interest in the 
proposed rule extended beyond the comments received on the proposal and 
at a furniture refinishing workshop described earlier. EPA continued 
discussions with the public to receive clarification on comments 
received on the proposed rule. This included meetings requested by W. 
M. Barr, Breast Cancer Prevention Partners, Natural Resources Defense 
Council, and Safer Chemicals Healthy Families, to discuss their 
comments and by families who have lost relatives using methylene 
chloride in paint removal (Refs. 16, 17, 18 and 19). EPA staff also 
attended a demonstration hosted by W. M. Barr of various paint and 
coating removal products (Ref. 20). EPA also consulted with state 
officials to discuss methylene chloride deaths reported since the 
proposal. (Ref. 21 and. Ref. 15).
    4. Risk evaluation of methylene chloride. EPA announced in December 
2016 its designation of methylene chloride as one of the ten chemical 
substances that will undergo risk evaluation pursuant to section 
6(b)(2)(A) of TSCA (81 FR 91927, December 19, 2016) (FRL-9956-47). The 
purpose of the risk evaluation under section 6(b)(4)(A) is to determine 
whether methylene chloride presents an unreasonable risk of injury to 
health or the environment under the conditions of use. The scope of the 
methylene

[[Page 11425]]

chloride risk evaluation identifies, among other issues, the conditions 
of use, including manufacturing, processing, and other uses beyond 
paint removal, such as adhesives and degreasing. If EPA makes a 
determination of unreasonable risk in the final risk evaluation for any 
of the other methylene chloride conditions of use included in that risk 
evaluation, EPA will subsequently issue a section 6(a) rule applying 
risk management requirements to the extent necessary so that such 
unreasonable risk is no longer present.
    With respect to this final rule for methylene chloride in consumer 
paint and coating removal, although some commenters questioned EPA's 
authority to issue a final rule on methylene chloride in paint and 
coating removal without finalizing the peer review of the supplemental 
analysis and other commenters urged EPA to use its discretion not to 
finalize the rule and instead re-evaluate the paint and coating removal 
use under the risk evaluation under section 6(b)(4)(A), the Agency is 
exercising its discretion to proceed with this final rule addressing 
unreasonable risk from methylene chloride in consumer paint and coating 
removal in accordance with TSCA section 26(l)(4). TSCA section 26(l)(4) 
(15 U.S.C. 2625(l)(4)) provides that, for a chemical substance listed 
in the 2014 update to the TSCA Work Plan for Chemical Assessments for 
which a completed risk assessment was published prior to the date of 
enactment of the Frank R. Lautenberg Chemical Safety for the 21st 
Century Act, EPA ``may publish proposed and final rules'' under TSCA 
section 6(a) that are consistent with the scope of the completed risk 
assessment and with other applicable requirements of TSCA section 6. 
Methylene chloride was listed in the 2014 update to the TSCA Work Plan 
and the completed risk assessment was published in 2014. EPA is 
publishing this final rule under TSCA section 6(a) in accordance with 
that discretionary authority.
    EPA is conducting a risk evaluation of the other conditions of use 
of methylene chloride under TSCA section 6(b). Additional information 
regarding the risk evaluation for the other conditions of use of 
methylene chloride, including public meetings, supporting documents, 
and public comments, is available in Docket Number EPA-HQ-OPPT-2016-
0742.

III. Provisions of This Final Rule

    EPA carefully considered all the public comments related to 
consumer paint and coating removal, as well as other information 
reasonably available in order to develop this final rule. As indicated 
previously, in this final action EPA is only addressing methylene 
chloride in consumer paint and coating removal and will address 
methylene chloride in commercial paint and coating removal in the 
future after soliciting comment, through an ANPRM published elsewhere 
in this issue of the Federal Register, on questions related to a 
potential training, certification, and limited access program. The 
changes from the proposed action to this final action related to 
methylene chloride in consumer paint and coating removal are:
     Further clarification in the final rule that paint and 
coating removers containing methylene chloride cannot be distributed to 
or by retailers and clarification that a retailer includes a person 
that distributes in commerce or makes available a chemical substance, 
mixture or article to consumers, including via internet sales or 
distribution. Any distributor with at least one consumer client is 
considered a retailer;
     A decision not to finalize the proposal's requirement for 
the distribution in commerce of methylene chloride for paint and 
coating removal in containers with a volume of less than 55 gallons. 
This requirement would have imposed an additional mitigation measure to 
address the risks to consumers from methylene chloride in consumer 
paint and coating removal. However, in this final rule, by eliminating 
access to methylene chloride for consumer paint and coating removal, 
via the retailer distribution restrictions, the unreasonable risk from 
consumer paint and coating removal use is addressed:
     A change in the date that the requirements begin for 
recordkeeping and for downstream notification of the prohibitions in 
this rule, from 45 days to 90 days after the effective date of the 
rule;
     Clarification that the downstream notification requirement 
should be done through the safety data sheets (SDSs) and provision of 
language required in the SDSs; and
     A provision allowing required records to be kept either at 
a company's headquarters or at the facility for which the records were 
generated.
    In addition, this action finalizes the general provisions related 
to definitions, exports and imports requirements, and enforcement and 
inspections. These provisions were originally presented in another 
proposed rule, entitled ``Trichloroethylene; Regulation of Certain Uses 
Under TSCA section 6(a)'' (Ref. 23). As EPA is newly establishing 40 
CFR part 751 to address the regulation of certain chemical substances 
and mixtures under TSCA section 6, the Agency intended that the general 
provisions presented in Subpart A of the proposed rule on 
trichloroethylene apply to all TSCA section 6 chemical substance 
regulations presented in part 751 (Ref. 23 at p. 91623). EPA's proposed 
rule on methylene chloride and NMP use in paint and coating removal 
specifically proposed to build upon the proposed part 751 presented 
therein, stating that the ``proposal relies on general provisions in 
the proposed part 751, subpart A, which can be found at 81 FR 91592 
(December 16, 2016)'' (Ref. 3 at p. 7519), and that ``40 CFR part 751, 
as proposed to be added at 81 FR 91592 (December 16, 2016), is proposed 
to be further amended'' by adding proposed regulatory provisions 
addressing paint and coating removal uses of methylene chloride and NMP 
in subparts B and C, respectively (Ref. 3 at p. 7529). Since the 
trichloroethylene rule has not been finalized, the proposed general 
provisions are included in this final action with two modifications:
    1. Further elaboration of TSCA section 6(a) requirements; and
    2. A minor modification to clarify that inspections will be 
conducted at EPA discretion in accordance with TSCA section 11 and are 
not required under that authority.

A. Scope and Applicability

    In this final action, EPA is regulating the manufacture (including 
import), processing and distribution in commerce of methylene chloride 
for consumer paint and coating removal, including distribution of 
methylene chloride for consumer paint and coating removal to and by 
retailers. The details of the prohibitions and requirements of this 
final rule are in Unit III.B.
    1. Paint and coating removal products. Methylene chloride has been 
used for decades in paint and coating removal in products intended for 
both consumer and commercial uses. Paint and coating removal, also 
referred to as paint stripping, is the process of removing paint or 
other coatings from a surface. Coatings can include paint, varnish, 
lacquer, graffiti, polyurethane, or other high-performance or specialty 
coatings. Surfaces or substrates may be the interior or exterior of 
buildings, structures, vehicles, aircraft, marine craft, furniture, or 
other objects and include a variety of materials, such as wood, metals, 
plastics, concrete, and fiberglass. Paint and coating removal can be 
conducted in consumer or occupational settings (Ref. 2).

[[Page 11426]]

    Paint and coatings can be removed by chemical, mechanical, or 
thermal means. Chemical paint removers can include solvents, such as 
methylene chloride, or caustic chemicals. Solvents permeate the top of 
the coating and dissolve the bond between the coating and the substrate 
(Ref. 22). Following the application of the chemical paint remover, the 
coating can be more easily peeled, scraped, or mechanically removed 
from the substrate. Techniques for applying the paint remover chemical 
include manual coating or brushing, tank dipping, flow-over systems, 
spray applications (manually or through automation), pouring, and 
wiping and rolling (manual or automated) (Ref. 2). Methylene chloride 
has been used to remove paint and coatings from walls, trim, furniture, 
architectural features, patios or decks, ceilings, bathtubs, floors, 
civilian aircraft, marine craft, cars, trucks, railcars, tankers, 
storage vessels, and other vehicles or their component parts to prepare 
for new coatings. Methylene chloride is typically applied to the 
surface using a hand-held brush, then left on to soften the old 
coating, and once curing has occurred, the old coating is scraped or 
brushed off to clean the surface. For bathtub refinishing, methylene 
chloride is poured and brushed onto a bathtub using a paintbrush and 
then scraped from the bathtub after leaving the remover to cure for 20 
to 30 minutes (Ref. 4). Consumer use of methylene chloride in paint and 
coating removal occurs in consumer settings, such as homes, workshops, 
basements, garages, attics, and outdoors. More information on specific 
paint removal techniques is in the methylene chloride risk assessment 
(Ref. 2).
    Though some users are switching to substitutes and alternative 
methods, methylene chloride use continues because it is readily 
available and works quickly and effectively on nearly all coatings 
without damaging most substrates. In addition, some users prefer 
methylene chloride because it is less flammable than some other 
solvents; however, paint and coating removal products formulated with 
methylene chloride tend to contain high concentrations of co-solvents 
that are flammable (Ref. 24). Also, methylene chloride is extremely 
volatile, has strong fumes, and evaporates quickly so that it must be 
reapplied for each layer of paint or coating to be removed.
    Products intended for one specific type of paint removal project 
can be easily used in a different setting, including by consumers or 
hobbyists (Refs. 8, 9, 10, and 25). Additionally, consumers can easily 
use paint removal products intended for or marketed to professional 
users since paint removal products are readily available at many big 
box, local hardware, and paint specialty stores. It should be noted 
that, while voluntary, several retailers have committed to phase out 
methylene chloride paint and coating removal products. EPA identified 
59 different products for paint and coating removal that contain 
methylene chloride, formulated by 10 different firms. This is 
approximately 54% of the total number of paint and coating removal 
products EPA identified (109 products) (Ref. 24). Paint and coating 
removers containing methylene chloride are frequently sold at stores 
that sell products to consumers as well as professional users. 
Additionally, due to the wide availability of products available on the 
internet and through various additional suppliers that serve commercial 
and consumer customers, consumers may foreseeably purchase a variety of 
paint and coating removal products containing methylene chloride. EPA 
estimated that approximately 1.3 million consumers and residential 
bystanders who use or are exposed to methylene chloride through 
consumer paint and coating removal each year (Ref. 4).
    2. Regulatory considerations. To identify the regulatory approach 
that would address the unreasonable risk presented by methylene 
chloride in paint and coating removal, EPA analyzed a wide range of 
regulatory options under section 6(a) in the proposed rule (Ref. 3 at 
pp. 7472, 7479).
    Section 6(c)(2)(A) of TSCA requires EPA, in proposing and 
promulgating section 6(a) rules, to include a statement addressing 
certain factors, including the costs and benefits and the cost 
effectiveness of the regulatory action and of the one or more primary 
alternative regulatory actions considered by the Administrator. In the 
proposed rule, EPA described its consideration of several alternative 
regulatory actions. One of the proposal's primary alternative 
regulatory actions consisted of: (i) An occupational respiratory 
protection program for the commercial uses proposed for regulation; 
(ii) a prohibition on distribution in commerce of methylene chloride 
for paint and coating removal in containers with a volume of less than 
55 gallons and 5 gallons for certain formulations as a means of 
limiting consumer access to methylene chloride paint and coating 
removal products (though it did not include restrictions on 
manufacturing, processing, or distribution of methylene chloride for 
consumer paint and coating removal); and (iii) required downstream 
notification.
    Since this final rule is not addressing commercial paint and 
coating removal, the primary alternative regulatory action considered 
in this final rule is slightly modified from the proposed rule, in that 
it does not include the occupational respiratory protection program for 
the commercial uses. Therefore, the primary alternative regulatory 
action for this final rule consists of: (a) Prohibition on distribution 
in commerce of methylene chloride for paint and coating removal in 
containers with a volume of less than 55 gallons and 5 gallons for 
certain formulations; and (b) downstream notification.
    This final regulatory action is consistent with the regulatory 
action proposed, which includes a prohibition on the manufacture, 
processing and distribution in commerce of methylene chloride for 
consumer paint and coating removal. The primary alternative regulatory 
action considered would have imposed additional mitigation measures to 
address the risk to consumers (i.e. 55-gallon containers) with 
additional burdens to processors and distributors; however, by 
eliminating access to methylene chloride for consumer paint and coating 
removal, via the retailer distribution restrictions, the unreasonable 
risk for consumer paint and coating removal use is addressed.
    The cost of the final rule is less than the cost of the primary 
alternative regulatory action considered. EPA's assessment of the costs 
and benefits of the primary alternative regulatory action are described 
in the Economic Analysis (Ref. 4) and in Unit III.A.3.
    3. TSCA section 6(c)(2) considerations. TSCA section 6(c)(2)(A) 
requires EPA to consider and publish a statement based on reasonably 
available information with respect to the chemical's effects on health 
and the magnitude of human exposure to the chemical. The following is 
EPA's statement with respect to this final rule.
    i. Health effects, exposure, and environmental effects. Methylene 
chloride is a neurotoxicant that can be acutely lethal. Exposure to 
methylene chloride can result in a range of adverse health effects, 
including effects on the nervous system, liver, respiratory system, 
kidneys, and reproductive systems. Methylene chloride is also a likely 
human carcinogen. The magnitude of exposure of human beings to 
methylene chloride use in consumer paint and coating removal is 
characterized by the number of users, in the case of this final action 
is estimated to be 1.3 million consumers and

[[Page 11427]]

residential bystanders who may not be engaged in paint and coating 
removal but who are exposed via inhalation to the chemical as a result 
of consumer paint and coating removal each year (Ref. 4). While 
methylene chloride is moderately persistent, given its low 
bioaccumulation and low hazard for aquatic toxicity (Ref. 2), the 
magnitude of potential environmental impacts on ecological receptors is 
judged to be low for the environmental releases associated with 
methylene chloride in consumer paint and coating removal (Ref. 3 at pp. 
7468, 7489).
    ii. The benefits of the chemical substance or mixture for various 
uses. Methylene chloride use in paint and coating removal provides 
benefits for some users because it is readily available and works 
quickly and effectively on nearly all coatings without damaging most 
substrates. In addition to paint and coating removal, methylene 
chloride is a solvent used in a variety of industrial, commercial and 
consumer use applications, including adhesives, pharmaceuticals, metal 
cleaning, chemical processing, and feedstock in the production of 
refrigerant hydrofluorocarbon-32 (Ref. 3 at p. 7467).
    iii. The reasonably ascertainable economic consequences of the 
rule. The reasonably ascertainable economic consequences of this rule 
include several components, all of which are described in the Economic 
Analysis for this final rule (Ref. 4). With respect to the anticipated 
effects of this rule on the national economy, EPA considered the number 
of businesses and workers that would be affected and the costs and 
benefits to those businesses and workers and did not find that there 
would be a significant impact on the national economy. In addition, EPA 
considered the employment impacts of this final rule, and found that 
the direction of change in employment is uncertain, but EPA expects the 
short-term and longer-term employment effects to be small. EPA 
estimates that impacts on small businesses are insignificant; EPA 
estimates that this final rule would affect approximately 7 small 
entities, with all small businesses having a cost impact of less than 
1% of the annual revenue.
    With respect to this rule's effect on technological innovation, EPA 
expects this rule to spur innovation, not hinder it. A prohibition on 
the manufacture, processing, and distribution of this use of methylene 
chloride is likely to increase demand for chemical substitutes. This 
rule is not likely to have significant effects on the environment, 
though it does present the potential for small reductions in air 
emissions and soil contamination associated with improper disposal of 
paint and coating removers containing methylene chloride. The effects 
of this rule on public health are estimated to be positive, due to the 
prevention of deaths from consumer exposure to methylene chloride when 
engaging in paint and coating removal with these products.
    The costs and benefits that can be monetized for this rule are 
described at length in Unit III.F and in the Economic Analysis (Ref. 
4). The costs for this rule are estimated to range from $3.8 to $13.6 
million annualized over 20 years at a 3% discount rate and $3.8 to 
$13.7 million annualized over 20 years at a 7% discount rate. The 
monetized benefits are estimated to be $3.5 million per year over 20 
years at 3% and 7% discount rate. This reflects the benefit to 
consumers.
    EPA considered the estimated costs to regulated entities as well as 
the cost to administer and enforce alternative regulatory actions. The 
primary alternative regulatory action would not include restrictions on 
manufacturing, processing, or distribution of methylene chloride for 
consumer paint and coating removal, but it would prohibit the 
distribution in commerce of methylene chloride for paint and coating 
removal in containers with a volume of less than 55 gallons, or 5 
gallons for certain formulations. In addition, downstream notification 
and recordkeeping would be required. The estimated annualized costs of 
this alternative regulatory action are $5.8 to $16.8 million at 3% and 
$5.8 to $16.8 million at 7% over 20 years (Ref. 4). The estimated 
annualized benefits of this alternative regulatory action are $13.0 to 
$13.1 million at 3% and $12.8 million at 7% over 20 years (Ref. 4). 
This reflects the $3.5 million per year benefits to consumers noted 
above and additional benefits to commercial users not targeted by the 
rule.
    The regulatory action finalized today is more cost effective than 
the primary alternative regulatory action because it achieves the 
necessary risk reduction for consumers and bystanders with estimated 
lower costs than the alternative regulatory action. The cost of the 
alternative regulatory action was estimated to be higher due to the 
cost of compliance with the container volume requirements which impact 
commercial users not targeted by the rule. However, the net benefits of 
the final regulatory action are estimated to be lower than the net 
benefits of the primary alternative regulatory action, since the 
primary alternative regulatory action includes benefits from preventing 
consumer users' exposure to methylene chloride in paint and coating 
removal, whereas the final regulatory action only includes benefits 
from eliminating consumer exposures to methylene chloride in paint and 
coating removal (Ref. 4).
    iv. Consideration of alternatives. In addition to the statement of 
effects and analysis of alternative regulatory actions required under 
TSCA section 6(c)(2)(A), section 6(c)(2)(C) requires EPA to consider, 
in deciding whether to prohibit or restrict in a manner that 
substantially prevents a specific condition of use, whether technically 
and economically feasible alternatives (e.g., substitute chemicals or 
alternative methods) that benefit health or the environment will be 
reasonably available as a substitute when the prohibition or 
restriction takes effect. In the proposed rule, EPA requested comment 
on the accuracy of its conclusion that identified substitutes for 
methylene chloride which are reasonably available and technically and 
economically feasible, and whether its consideration of chemical 
substitutes and alternative methods met the requirements of TSCA 
section 6(c)(2)(C). EPA received several comments on this subject. A 
majority of commenters indicated that effective, safer alternatives are 
already available for paint and coating removal, and that EPA has amply 
satisfied TSCA section 6(c)(2)(C) requirements by identifying a number 
of available, preferable substitutes, including non-chemical 
substitutes. Some commenters raised concerns regarding alternatives and 
claimed EPA failed to satisfy the requirements of TSCA section 
6(c)(2)(C) because the Agency erroneously concluded that technically 
and economically feasible alternative paint strippers exist. EPA 
disagrees with the comments that for consumer users, available 
alternative formulations are less safe and more expensive than products 
with methylene chloride, although EPA does recognize that many factors 
need to be considered when choosing the appropriate alternative. 
Substitute products currently are available for consumer users of 
methylene chloride for paint and coating removal, for a variety of 
coatings on numerous substrates (Refs. 26 and 27). None of the 
substitute chemicals already available has the level of toxicity 
associated with methylene chloride (Ref. 24). As EPA stated in the 
proposed rule, EPA is aware of technically and economically feasible 
chemical substitutes or alternative methods that are reasonably 
available to a consumer for almost every situation in

[[Page 11428]]

which methylene chloride is used to remove paints or coatings (Ref. 3 
at p. 7485). A summary of comments related to substitute products, and 
EPA's response, is in the docket for this action (Ref. 15).
    4. TSCA section 9(a) analysis. Section 9(a) of TSCA describes the 
steps EPA must take if the EPA Administrator determines in his 
discretion that an unreasonable risk may be prevented or reduced to a 
sufficient extent by an action taken under a Federal law not 
administered by EPA. These steps include submitting a report to the 
agency administering that other law that describes the risk and the 
activities that present such risk. EPA has not made such a 
determination, and, in the proposed rule, EPA explained its reasoning. 
TSCA section 9(d) further instructs the Administrator to consult and 
coordinate TSCA activities with other Federal agencies for the purpose 
of achieving the maximum enforcement of TSCA while imposing the least 
burden of duplicative requirements. In the proposed rule, EPA described 
its consultations with CPSC and with OSHA, and letters documenting this 
consultation are in the docket (Refs. 28 and 29).
    CPSC's mission is to protect the public from unreasonable risks of 
injury or death associated with the use of consumer products under the 
agency's jurisdiction. CPSC recently updated its guidance on labeling 
for certain products containing methylene chloride to explain that 
covered products that do not bear a prominent warning about the risk of 
death in enclosed spaces are considered misbranded hazardous substances 
under the Federal Hazardous Substances Act, 15 U.S.C. 1261-1276. One of 
the specifically-stated purposes for the update was to provide more 
immediate guidance and clarity to consumers and industry regarding the 
acute hazards associated with using methylene chloride based paint 
removers while they remain on the market (83 FR 12254, March 21, 2018). 
In that guidance, CPSC specifically stated that, ``we do not suggest 
that labeling will address all hazards EPA identified in its proposed 
rulemaking'' regarding methylene chloride use in paint and coating 
removal products. While EPA believes that the updated CPSC labeling 
guidance, if properly implemented by industry, would prevent some users 
from using methylene chloride paint and coating removal products in an 
unsafe manner, for the reasons described in the proposal, it is 
unlikely to mitigate the unreasonable risks to consumers identified by 
EPA so that they are no longer unreasonable.
    OSHA's mission is to assure safe and healthful working conditions 
for working men and women by setting and enforcing standards and by 
providing training, outreach, education and assistance. OSHA's 
authority does not address unreasonable risk from methylene chloride in 
consumer paint and coating removal.
    In this final rule, EPA has not used its discretion to make a 
determination that unreasonable risks from the use of methylene 
chloride in consumer paint and coating removal may be prevented or 
reduced to a sufficient extent by an action taken under a Federal law 
not administered by EPA, and therefore there is no need to submit a 
report to CPSC or OSHA under TSCA section 9(a).
    More than 20 comments were received regarding issues generally 
related to TSCA section 9. Some commenters supported EPA's decision to 
not make a determination and submit a report to another agency under 
TSCA section 9(a). These commenters agreed with EPA's reasoning on the 
ability of other authorities to address the unreasonable risks 
identified by EPA. Other commenters contended that the OSHA regulations 
and the CPSC labeling guidance were sufficient to address the risks EPA 
identified, especially given the fact that CPSC was in the process of 
revising its labeling guidance for methylene chloride. Others thought 
that, to the extent that EPA had identified risks to consumers and 
others that were not adequately addressed by the current CPSC guidance 
or OSHA regulations, a report from EPA under TSCA section 9(a) would 
have alerted the other agencies to the potential deficiencies.
    In this case, EPA disagrees with those commenters who thought that 
EPA must make a determination that other authorities administered by 
other agencies could address the unreasonable risks identified by EPA.
    5. TSCA section 9(b) analysis. TSCA section 9(b) directs EPA to use 
other authorities administered by EPA to protect against a risk to 
health or the environment if EPA determines that such risk could be 
eliminated or reduced to a sufficient extent by actions taken under 
those authorities, unless EPA determines that it is in the public 
interest to protect against such risk by actions taken under TSCA.
    Although several EPA statutes have been used to limit methylene 
chloride exposure, as described in the proposed rule, the acute 
unreasonable risks EPA has identified could not be addressed through 
these other statutes.
    For this reason, the Administrator is not making a determination 
that the unreasonable risks of injury to health due to acute human 
lethality from the use of methylene chloride in consumer paint and 
coating removal could be eliminated or reduced to a sufficient extent 
by actions taken under other Federal laws administered in whole or in 
part by EPA. Another commenter stated that EPA failed to meet its 
obligations under TSCA section 9(b) because EPA did not compare the 
estimated costs and efficiencies of acting under TSCA or other statutes 
administered by EPA. EPA disagrees with this commenter's reading of 
TSCA section 9(b). The obligation to compare costs and efficiencies 
only arises after EPA has first determined that the identified 
unreasonable risks could be adequately addressed through action under 
another statute administered by EPA, and also determines that it is in 
the public interest to act under TSCA rather than the other statute. In 
this case, EPA has made neither of those determinations.
    6. TSCA section 26(h) considerations. EPA has used scientific 
information, technical procedures, measures, methods, protocols, 
methodologies, and models consistent with the best available science at 
the time the risk assessment for methylene chloride was conducted. 
These information sources supply information relevant to whether the 
use of methylene chloride in paint and coating removal would present an 
acute unreasonable risk. For example, the 2014 risk assessment used 
best available science and methods, was peer reviewed, and went through 
a public comment process (Ref. 2).
    The clarity and completeness of the data, assumptions, methods, 
quality assurance, and analyses employed in EPA's decision are 
documented, as applicable and to the extent necessary for purposes of 
this final rule, in the proposed rule (Ref. 3 at p. 7521) and in the 
references cited throughout the preamble of the proposed and this final 
rule. While EPA recognizes, based on the available information, that 
there is variability and uncertainty with regard to EPA's risk 
assessment of the use of methylene chloride in paint and coating 
removal, those uncertainties were identified in the proposed rule (Ref. 
3 at p. 7491) and were characterized and documented in the methylene 
chloride risk assessment (Ref. 2). The extent to which the various 
information, procedures, measures, methods, protocols, methodologies or 
models, as applicable, used in EPA's decision have

[[Page 11429]]

been subject to independent verification or peer review is adequate to 
justify their use, collectively, in the record for this rule. 
Additional information on the peer review and public comment process, 
such as the peer review plan, the peer review report, and EPA's 
response to comments, is in Docket Number EPA-HQ-OPPT-2012-0725.
    EPA received several public comments on the proposed rule relating 
to the scientific information, technical procedures, measures, methods, 
protocols, methodologies, and models used by EPA. Commenters disagreed 
on whether EPA's assessment of methylene chloride was scientifically 
rigorous, with some praising EPA for a strong scientific underpinning 
for the regulation and others stating that EPA did not use best 
available science by incorporating exposure data that were out of date 
or by not correctly using a weight-of-evidence for some findings. EPA 
disagrees with commenters that the exposure data should not be used, or 
that weight-of-evidence was applied incorrectly. This action based on 
acute unreasonable risks is supported by a risk assessment that 
underwent peer review and a public comment process. More details on 
these comments and EPA's response is in the Response to Comments 
document (Ref. 15).

B. Prohibitions and Requirements

    This final rule:
    1. Prohibits the manufacturing, processing, and distribution in 
commerce of methylene chloride for paint and coating removal for all 
consumer uses;
    2. Prohibits the distribution in commerce of methylene chloride in 
paint and coating removal products to and by retailers. A retailer is 
any person or business entity that distributes or makes available paint 
and coating removal products to consumers, including through ecommerce 
internet sales or distribution. If a person or business entity 
distributes or makes available any methylene chloride-containing paint 
or coating removal product to at least one consumer, then it is 
considered a retailer. For a distributor not to be considered a 
retailer, he/she must distribute or make available methylene chloride-
containing paint and coating removal products solely to commercial or 
industrial end users or businesses. This additional provision clarifies 
the proposed regulation and ensures that retailers will not be able to 
purchase for sale or distribution to consumers, or to make available to 
consumers, paint and coating removal products containing methylene 
chloride;
    3. Requires manufacturers, processors, and distributors of 
methylene chloride for any use, excluding retailers, to provide 
downstream notification of the prohibitions in this final rule through 
SDSs by adding to sections 1(c) and 15 of the SDS the following 
language: ``This chemical/product is not and cannot be distributed in 
commerce (as defined in TSCA section 3(5)) or processed (as defined in 
TSCA section 3(13)) for consumer paint or coating removal.''; and
    4. Requires recordkeeping relevant to these prohibitions.
    The prohibition on manufacturing, processing, and distribution in 
commerce of methylene chloride for consumer paint and coating removal, 
including distribution to and by retailers, will take effect 180 days 
after the effective date of this final rule. EPA believes this is a 
reasonable transition period and will not result in additional costs of 
collecting and disposal of any stranded products. EPA recognizes that 
some individual retailers might not be as efficient with their 
inventory management and that could result in stranded products and 
some additional cost for disposal of such products.
    Each person who manufactures, processes, or distributes in commerce 
methylene chloride is required to provide downstream notification of 
the restrictions in this rule through SDSs, effective 90 days following 
the effective date of this final rule. Downstream notification ensures 
that processors and distributors are aware of the restrictions for 
methylene chloride in paint and coating removal; enhances the 
likelihood that the risks associated with this use of methylene 
chloride are addressed throughout the supply chain; and also 
streamlines compliance and enhances enforcement, since compliance is 
improved when rules are clearly and simply communicated (Ref. 30).
    After 90 days following the effective date of this final rule, each 
person who manufactures, processes, or distributes in commerce 
methylene chloride must retain documentation of the entities to whom 
methylene chloride was shipped, a copy of the downstream notification 
provided, and the amount of methylene chloride shipped. The 
documentation must be retained for 3 years from the date of shipment. 
Based on a public comment, EPA added to the final rule a provision to 
keep the required records either at the company's headquarters or at 
the facility for which the records were generated.
    This final rule also includes a definition of retailers and 
consumer paint and coating removal in order to be responsive to 
comments received requesting EPA to provide more clarity regarding the 
regulated distribution to consumers.

C. Downstream Notification

    EPA received four comments related to downstream notification of 
methylene chloride restrictions, one of which took issue with EPA's 
approach. This commenter stated that EPA lacks the authority to require 
downstream notification and recordkeeping beyond the scope of the 
conditions of use identified in its unreasonable risk finding. While 
EPA recognizes there are companies likely manufacturing, processing, or 
distributing methylene chloride or products containing methylene 
chloride for uses that will not be regulated under this final rule, EPA 
disagrees with the commenter's reading of the statute that section 
6(a)(3) downstream notification requirements do not apply to conditions 
of use other than those for which EPA is addressing the unreasonable 
risk for a chemical substance.
    TSCA section 6(a) requires EPA to impose one or more of the 
specified requirements to the extent necessary so that a chemical 
substance no longer presents an unreasonable risk identified by EPA. 
Here, EPA has determined that the downstream notification provisions 
are necessary to prevent the identified unreasonable risk. Without 
downstream notification, manufacturers, processors, and distributors, 
are likely to be unfamiliar with the prohibitions against distribution 
of methylene chloride-containing paint and coating removal products to 
and by retailers. As such, the notification helps ensure that all 
downstream entities are aware of the prohibitions. Further, 
notification throughout the supply chain streamlines compliance and 
enhances enforcement, since compliance can be improved when rules are 
clearly and simply conveyed. Moreover, under section 6, EPA has 
authority to require reporting and recordkeeping related to the 
regulatory requirements imposed by EPA under section 6. See, e.g., 55 
FR 222 (EPA's section 6 action on hexavalent chromium in cooling 
towers).
    Some commenters requested more clarity from EPA regarding how to 
use the SDS for downstream notification. In this final rule, EPA is 
specifying the changes to the SDS needed for the downstream 
notification. Specifically, EPA is requiring the addition of the 
following language to sections 1(c) and 15 of the SDS: ``This chemical/
product is not and cannot be distributed in commerce (as defined in 
TSCA section

[[Page 11430]]

3(5)) or processed (as defined in TSCA section 3(13)) for consumer 
paint or coating removal.''
    The effective date of the requirement for this notification and the 
associated recordkeeping is 90 days after the effective date of this 
action. The proposed rule would have had these requirements take effect 
45 days after the effective date of this final rule. On further 
reflection, EPA has determined that 90 days is a more reasonable 
transition period. Regulated entities need only to provide additional 
information on their SDS, which is routinely produced and updated.

D. Import Certification

    Persons who import any chemical substance governed by a final TSCA 
section 6 rule are subject to the TSCA section 13 (15 U.S.C. 2612) 
import certification requirements and the corresponding regulations at 
19 CFR 12.118 through 12.127; see also 19 CFR 127.28. To comply with 
the import certification requirements, importers (or their agents) will 
be required to certify that the shipment of methylene chloride complies 
with all applicable rules and orders under TSCA. The EPA policy in 
support of import certification appears at 40 CFR part 707, subpart B. 
In addition, any persons who export or intend to export methylene 
chloride are subject to the export notification provisions of TSCA 
section 12(b) (15 U.S.C. 2611(b)), and must comply with the export 
notification requirements in 40 CFR part 707, subpart D.

E. Enforcement

    Section 15 of TSCA makes it unlawful to fail or refuse to comply 
with any provision of a rule promulgated under TSCA section 6. 
Therefore, any failure to comply with this rule when it becomes 
effective would be a violation of section 15 of TSCA. In addition, 
section 15 of TSCA makes it unlawful for any person to: (1) Fail or 
refuse to establish and maintain records as required by this rule; (2) 
fail or refuse to permit access to or copying of records, as required 
by TSCA; or (3) fail or refuse to permit entry or inspection as 
required by section 11 of TSCA.
    Violators may be subject to both civil and criminal liability. 
Under the penalty provision of section 16 of TSCA, any person who 
violates section 15 could be subject to a civil penalty for each 
violation. Each day in violation of this final rule, after the 
effective date could constitute a separate violation. Knowing or 
willful violations could lead to the imposition of criminal penalties 
for each day of violation and imprisonment. In addition, other remedies 
are available to EPA under TSCA.
    Individuals, as well as corporations, could be subject to 
enforcement actions. Sections 15 and 16 of TSCA apply to ``any person'' 
who violates various provisions of TSCA. EPA may, at its discretion, 
proceed against individuals as well as companies. In particular, EPA 
may proceed against individuals who report false information or cause 
it to be reported.

F. Costs, Benefits, and Impacts

    EPA evaluated the costs and benefits of this final action, which is 
presented in the Economic Analysis (Ref. 4) and summarized in this 
unit.
    1. Overview of public comments. Of the nine comments received 
related to the Economic Analysis, three comments supported EPA's 
Economic Analysis. One commenter stated that EPA conducted a thorough 
cost-benefit analysis, and appropriately provided an in depth 
qualitative description of health benefits. Other commenters pointed 
out perceived shortcomings of the Economic Analysis conducted by the 
Agency, with one commenter calling for the underlying Economic Analysis 
data to be more comprehensive, accurate, and reflective of current 
industry practices. These comments, and EPA's response, are in the 
Response to Comments document in this docket (Ref. 15).
    2. Costs. The details of the costs of this final rule are 
summarized in Unit I.E and discussed in the Economic Analysis (Ref. 4). 
Under this final rule, costs to users of paint and coating removal 
products containing methylene chloride are approximately $3.8 to $13.6 
million annualized for 20 years at a discount rate of 3% and $3.8 to 
$13.7 million at a discount rate of 7%. Costs to manufacturers of 
methylene chloride are $50 and $60 annualized for 20 years at a 
discount rate of 3% and 7% respectively. Costs for processors, 
including those associated with reformulation, downstream notification 
and label changes, on an annualized basis over 20 years are $ 15,000 to 
$25,000 using 3% and $20,000 to $34,000 using 7% discount rates. Agency 
costs for enforcement are estimated to be approximately $147,000 and 
$145,000 annualized over 20 years at 3% and 7%, respectively. Total 
costs of this final rule are estimated to be approximately $3.8 to 
$13.6 million annualized over 20 years at 3% and $3.8 to $13.7 million 
annualized over 20 years at 7%.
    3. Benefits. EPA is not fully able to quantify the full monetary 
benefits that would accrue from preventing all consumer deaths due to 
methylene chloride in paint and coating removal and the impacts of the 
substitution effect by switching from methylene chloride to alternative 
chemicals and methods. Similarly, EPA is not able to monetize the 
benefits that would accrue from preventing non-fatal and non-cancer 
effects from exposure to methylene chloride in paint and coating 
removal. The subset of benefits that can be monetized from mitigating 
the risks from methylene chloride in paint and coating removal for 
consumers finalized by this rule are potential avoidance of fatalities 
and are estimated to be approximately $3.5 million (annualized at 3% 
and 7% over 20 years) (Ref. 4).
    4. Comparison of benefits and costs. The monetized subset of 
benefits from preventing the risks resulting from methylene chloride in 
consumer paint and coating removal are less than the estimated monetary 
costs.
    5. Impacts on the national economy, small businesses, technological 
innovation, the environment, and public health. As summarized in Unit 
I.E and III.A.3 and described in the Economic Analysis (Ref. 4), EPA 
considered the anticipated effects of this final rule. With respect to 
the national economy, as EPA indicated in the proposed rule (Ref. 3 at 
p. 7489), EPA considered the number of businesses and workers that 
would be affected and the costs and benefits to those businesses and 
workers. EPA did not find that there would be a significant impact on 
the national economy (Ref. 4). In addition, EPA considered the 
employment impacts of this final rule, and found that the direction of 
change in employment is uncertain, but EPA expects the short term and 
longer-term employment effects to be small (Ref. 4). EPA estimates that 
impacts on small businesses are insignificant; EPA estimates that this 
final rule would affect approximately 7 small entities, with all small 
businesses having a cost impact of less than 1% of the annual revenue, 
(Ref. 4). As EPA indicated in the proposed rule, with respect to this 
rule's effect on technological innovation, EPA expects this action to 
spur innovation, not hinder it. A prohibition on the manufacturing, 
processing, and distribution in commerce of methylene chloride for 
consumer paint and coating removal is likely to increase demand for 
alternatives (Ref. 4). This rule is not likely to have significant 
effects on the environment, though it does present the potential for 
small reductions in air emissions and soil contamination associated 
with improper disposal of paint and coating removers containing

[[Page 11431]]

methylene chloride. The effects of this rule on public health are 
estimated to be positive, due to the prevention of deaths and nonlethal 
adverse health effects due to consumer exposure to methylene chloride 
when engaging in paint and coating removal (Ref. 3 at p. 7489).
    6. Impacts of the final and alternative regulatory actions. The 
costs of this final rule are estimated to include costs to users of 
paint and coating removal products containing methylene chloride, 
product reformulation costs, downstream notification costs, 
recordkeeping costs, and Agency costs.
    The primary alternative regulatory action considered by EPA would 
not include restrictions on manufacturing, processing, or distribution 
of methylene chloride for consumer paint and coating removal, but it 
would require the distribution in commerce of methylene chloride for 
paint and coating removal in containers with a volume of no less than 
55 gallons, or 5 gallons for certain formulations. In addition, 
downstream notification and recordkeeping would be required. As 
required under TSCA section 6(c), EPA analyzed the costs and benefits 
of this primary alternative action and found that this approach would 
introduce additional burdens to processors and distributors who would 
bear the cost of ensuring products are in 55- and 5-gallon containers, 
as appropriate. In addition, the 55-gallon volume restriction would 
effectively bar most commercial users in the professional contractor, 
bathtub refinishing, and graffiti removal sectors given the increased 
cost and, for some users, impracticality of using large containers.
    The regulatory action finalized today is more cost effective 
because it achieves the necessary risk reduction for consumers and 
bystanders with estimated lower costs than the alternative regulatory 
action. The cost of the alternative regulatory action was estimated to 
be higher due to the cost of compliance with the container volume 
requirements. However, the net benefits of the final regulatory action 
are estimated to be lower than the net benefits of the primary 
alternative regulatory action, since the primary alternative regulatory 
action includes benefits from preventing consumer users' exposure, 
whereas the final regulatory action only includes benefits from 
eliminating consumer exposures to methylene chloride in paint and 
coating removal. A summary of the findings of this analysis are in 
III.A.3 and in the Economic Analysis (Ref. 4).

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 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 
technical person listed under FOR FURTHER INFORMATION CONTACT.

1. EPA. TSCA Work Plan for Chemical Assessments: 2014 Update. 
https://www.epa.gov/sites/production/files/2015-01/documents/tsca_work_plan_chemicals_2014_update-final.pdf. Retrieved December 
4, 2018.
2. EPA. TSCA Work Plan Chemical Risk Assessment Methylene Chloride: 
Paint Stripping Use. CASRN 75-09-2. EPA Document# 740-R1-4003. 
August 2014. Office of Chemical Safety and Pollution Prevention. 
Washington, DC https://www.epa.gov/sites/production/files/2015-09/documents/dcm_opptworkplanra_final.pdf. Retrieved December 4, 2018.
3. EPA. Methylene Chloride and N-Methylpyrrolidone; Regulation of 
Certain Uses Under TSCA Section 6(a); Proposed Rule. Federal 
Register (82 FR 7464, January 19, 2017) (FRL-9958-57).
4. EPA. Economic Analysis of Final Rule TSCA Section 6 Action on 
Methylene Chloride in Paint and Coating Removal (EPA Docket EPA-HQ-
OPPT-2016-0231; RIN 2070-AK07). Office of Pollution Prevention and 
Toxics. Washington, DC.
5. EPA. Toxicological Review of Methylene Chloride (CAS No. 75-09-
2). EPA/635/R-10/003F. Integrated Risk Information System, 
Washington, DC. November 2011.
6. EPA. Public Database 2016 Chemical Data Reporting (May 2017 
Release). Washington, DC: US Environmental Protection Agency, Office 
of Pollution Prevention and Toxics. Retrieved from https://www.epa.gov/chemical-data-reporting.
7. EPA. Scope of the Risk Evaluation for Methylene Chloride 
(Dichloromethane, DCM) EPA-HQ-OPPT-2016-0742-0061. Office of 
Pollution Prevention and Toxics. Washington, DC. June 2017.
8. OSHA. ``Lethal Exposure to Methylene Chloride during Bathtub 
Refinishing.'' OSHA Fatal Facts. 2016. https://www.osha.gov/Publications/OSHA3883.pdf.
9. Centers for Disease Control and Prevention (CDC). ``Fatal 
Exposure to Methylene Chloride Among Bathtub Refinishers--United 
States, 2000-2011.'' Morbidity and Mortality Weekly Report. February 
24, 2012. Vol 61(7), p 119-122.
10. EPA. Memo: Methylene Chloride Paint and Coating Removal 
Fatalities: 2017-2018. (EPA Docket EPA-HQ-OPPT-2016-0231). Office of 
Pollution Prevention and Toxics. Washington, DC.
11. California Code of Regulations. ``Proposal to List Paint or 
Varnish Strippers Containing Methylene Chloride as a Priority 
Product.'' Proposed Regulation Text. November 2017. https://calsafer.dtsc.ca.gov/cms/commentpackage/?rid=12734.
12. ``Proposition 65 Law and Regulations.'' Nov 14, 2016. http://www.oehha.ca.gov/prop65/law/P65law72003.html.
13. EPA. TSCA Work Plan Chemicals: Methods Document. http://www.epa.gov/sites/production/files/2014-03/documents/work_plan_methods_document_web_final.pdf. Retrieved February 25, 
2016.
14. EPA. Final Report of the Small Business Advocacy Review Panel on 
EPA's Planned Proposed Rule on the Toxic Substances Control Act 
(TSCA) Section 6(a) as amended by the Frank R. Lautenberg Chemical 
Safety for the 21st Century Act for Methylene Chloride and N-
Methylpyrrolidone (NMP) in Paint Removers. Office of Chemical Safety 
and Pollution Prevention. Washington, DC. 2016.
15. EPA. Response to Comments on the Final Methylene Chloride Rule; 
Regulation of Certain Uses Under TSCA Section 6(a) (EPA Docket EPA-
HQ-OPPT-2016-0231). Office of Pollution Prevention and Toxics. 
Washington, DC.
16. EPA. Outreach Meeting with W. M. Barr and EPA to discuss the 
Methylene Chloride in Paint and Coating Removal. (EPA Docket EPA-HQ-
OPPT-2016-0231). Office of Pollution Prevention and Toxics. 
Washington, DC.
17. EPA Outreach Meeting with Breast Cancer Prevention Partners 
(BCPP) and Safer Chemicals Healthy Families (SCHF) and EPA to 
discuss the Methylene Chloride in Paint and Coating Removal. (EPA 
Docket EPA-HQ-OPPT-2016-0231) Office of Pollution Prevention and 
Toxics. Washington, DC.
18. EPA Outreach Meeting with Natural Resources Defense Council and 
Safer Chemicals Healthy Families (SCHF) and EPA to discuss the 
Methylene Chloride in Paint and Coating Removal. (EPA Docket EPA-HQ-
OPPT-2016-0231) Office of Pollution Prevention and Toxics. 
Washington, DC.
19. EPA Meeting with families who have lost relatives using 
methylene chloride in paint removal. (EPA Docket EPA-HQ-OPPT-2016-
0231) Office of Pollution Prevention and Toxics. Washington, DC.
20. EPA. Demonstration of Paint Removing products by W.M. Barr. (EPA 
Docket EPA-HQ-OPPT-2016-0231) Office of Pollution Prevention and 
Toxics. Washington, DC.
21. EPA. Outreach Meeting with Federal and State Agencies on Recent 
Methylene Chloride Fatalities. (EPA Docket EPA-HQ-OPPT-2016-0231). 
Office of Pollution Prevention and Toxics. Washington, DC.
22. ``Paint Strippers, Types of Strippers.'' PaintPRO, Vol. 3, No. 
3. June 2000. http://www.paintpro.net/Articles/PP303/PP303_strippers.cfm.

[[Page 11432]]

23. EPA. Trichloroethylene; Regulation of Certain Uses Under TSCA 
Section 6(a); Proposed Rule. Federal Register (81 FR 91592, December 
16, 2016) (FRL-9949-86).
24. EPA. Analysis Report of Chemical Alternatives for Use of 
Methylene Chloride[hyphen] and N-Methylpyrrolidone[hyphen]based 
Paint Removers: Hazard and Exposure Concerns. 2016.
25. National Institute for Occupational Safety and Health (NIOSH) 
and Occupational Safety and Health Administration (OSHA). Hazard 
Alert: Methylene Chloride Hazards for Bathtub Refinishers. January 
2013. http://www.cdc.gov/niosh/docs/2013-110/Accessed April 14, 
2016.
26. Morris, M.; Wolf, K. Institute for Research and Technical 
Assistance. ``Methylene Chloride Consumer Product Paint Strippers: 
Low-VOC, Low Toxicity Alternatives Prepared For: Cal-EPA's 
Department of Toxic Substances Control.'' May 2006. http://www.irta.us/Methylene%20Chloride%20Consumer%20Product%20Paint%20Strippers%20REPORT%20ONLY.pdf.
27. Jacobs, Molly; Bingxuan Wang, Mark Rossi. ``Alternatives to 
Methylene Chloride in Paint and Varnish Strippers.'' BizNGO. (2015): 
1-44. http://www.bizngo.org/resources/entry/resource-methylene.
28. United States Consumer Product Safety Commission (CPSC). Letter 
to James J. Jones from Patricia H. Adkins. April 19, 2016.
29. U.S. Department of Labor--Occupational Safety and Health 
Administration (OSHA). Letter to James J. Jones from David Michaels, 
Ph.D., MPH. March 31, 2016.
30. Giles, C. EPA. ``Next Generation Compliance.'' Environmental 
Forum. October 2013, p 22-26. Washington, DC.
31. EPA. Final Regulatory Flexibility Analysis for Methylene 
Chloride; Regulation of Certain Uses Under TSCA Section 6(a); Final 
Rule; RIN 2070-AK07. Office of Chemical Safety and Pollution 
Prevention. Washington, DC. 2019.
32. EPA. Supporting Statement for an Information Collection Request 
(ICR) Under the Paperwork Reduction Act (PRA). March 2019.
33. EPA. Section 6(a) Rulemakings under the Toxic Substances Control 
Act (TSCA) Paint Removers & TCE Rulemakings E.O. 13132: Federalism 
Consultation. May 13, 2015.
34. EPA. Notification of Consultation and Coordination on Proposed 
Rulemakings under the Toxic Substances Control Act for 1) Methylene 
Chloride and n-Methylpyrrolidone in Paint Removers and 2) 
Trichloroethylene in Certain Uses. April 8, 2015.
35. EPA. Paint Removers: Methylene Chloride and N-
Methylpyrrolidone--Community Webinar. May 28, 2015.

V. Statutory and Executive Order Reviews

    Additional information about these statutes and Executive Orders 
can be found at http://www2.epa.gov/laws-regulations/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 under Executive 
Order 12866 (58 FR 51735, October 4, 1993) and Executive Order 13563 
(76 FR 3821, January 21, 2011). Any changes made in response to OMB 
recommendations have been documented in the docket. EPA prepared an 
economic analysis of the potential costs and benefits associated with 
this action, which is available in the docket and summarized in Units 
I.E., III.A.3., and III.G. (Ref. 4).

B. Executive Order 13771: Reducing Regulation and Controlling 
Regulatory Costs

    This action is subject to the requirements for regulatory actions 
specified in Executive Order 13771 (82 FR 9339, February 3, 2017). 
Details on the estimated costs of this final rule can be found in EPA's 
analysis (Ref. 4) of the potential costs and benefits associated with 
this action, which is available in the docket and is summarized in Unit 
III.F.

C. Paperwork Reduction Act (PRA)

    The information collection requirements in this rule have been 
submitted for approval to OMB under the PRA, 44 U.S.C. 3501 et seq. The 
Information Collection Request (ICR) document prepared by EPA has been 
assigned EPA ICR No. 2556.02 and OMB Control No. 2070-0204. You can 
find a copy of the ICR in the docket for this rule (Ref. 32), and it is 
briefly summarized here. This rule does not require the regulated 
entities to submit information to EPA.
    The information collection activities required by this rule include 
a downstream notification requirement and a recordkeeping requirement. 
The downstream notification would require companies that ship methylene 
chloride to notify companies downstream in the supply chain through the 
SDS of the prohibitions described in this final rule. The recordkeeping 
requirement mandates companies that ship methylene chloride to retain 
certain information at the company headquarters, or at the facility for 
which the records were generated, for three years from the date of 
shipment. These information collection activities are necessary in 
order to enhance the prohibitions under this rule by ensuring awareness 
of the prohibitions throughout the methylene chloride supply chain, and 
to provide EPA with information upon inspection of companies downstream 
who purchased methylene chloride. This rule does not require 
confidential or sensitive information to be submitted to EPA or 
downstream companies. EPA believes that these information collection 
activities would not significantly impact the regulated entities as the 
downstream notification requirements is a simple modification to the 
SDS and recordkeeping requirements include information that is part of 
the normal course of business.
    Respondents/affected entities: Methylene chloride manufacturers, 
processors, and distributors.
    Respondent's obligation to respond: Respondents are not obligated 
to respond or report to EPA, but must notify downstream users and 
maintain required records.
    Estimated number of respondents: 138.
    Frequency of response: On occasion to third parties as needed.
    Total estimated annual burden: 69 hours. Burden is defined at 5 CFR 
1320.3(b).
    Total estimated annual cost: $3,712.
    An agency may not conduct or sponsor, and a person is not required 
to respond to, a collection of information unless it displays a 
currently valid OMB control number. The OMB control numbers are 
displayed either by publication in the Federal Register or by other 
appropriate means, such as on the related collection instrument or 
form, if applicable. The OMB control numbers for certain EPA 
regulations are listed in 40 CFR part 9.

D. Regulatory Flexibility Act (RFA)

    Pursuant to sections 603 and 609(b) of the RFA, EPA prepared an 
initial regulatory flexibility analysis (IRFA) for the proposed 
rulemaking and convened a Small Business Advocacy Review (SBAR) Panel 
to obtain advice and recommendations from small entity representatives 
that potentially would be subject to the rule's requirements. Summaries 
of the IRFA and Panel recommendations are presented in the proposed 
rulemaking (Ref. 3).
    As required by section 604 of the RFA, EPA prepared a final 
regulatory flexibility analysis (FRFA) for this action (Ref. 31). The 
FRFA addresses the issues raised by public comments on the IRFA for the 
proposed rulemaking. The

[[Page 11433]]

complete FRFA is available for review in the docket and is summarized 
here.
    1. Statement of need and rule objectives. The purpose of this 
action is to prevent acute fatalities from the use of methylene 
chloride in consumer paint and coating removal. Under TSCA section 6(a) 
(15 U.S.C. 2605(a)), if EPA determines that 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 
identified as relevant, under the conditions of use, EPA must by rule 
apply one or more requirements to the extent necessary so that the 
chemical substance no longer presents such risk.
    With respect to a chemical substance listed in the 2014 update to 
the TSCA Work Plan for Chemical Assessments for which a completed risk 
assessment was published prior to the date of enactment of the Frank R. 
Lautenberg Chemical Safety for the 21st Century Act (which includes 
methylene chloride), TSCA section 26(l)(4) (15 U.S.C. 2625(l)(4)) 
provides that EPA ``may publish proposed and final rules'' under TSCA 
section 6(a) that are consistent with the scope of the completed risk 
assessment and consistent with other applicable requirements of TSCA 
section 6. EPA is publishing this final rule under TSCA section 6(a) in 
accordance with that discretionary statutory authority.
    Based on EPA's analysis of consumer population exposures to 
methylene chloride in paint and coating removal, EPA is making a final 
determination that the use of methylene chloride in consumer paint and 
coating removal presents an unreasonable risk of injury to health due 
to acute human lethality. This final rule addresses that unreasonable 
risk.
    EPA believes this rule will be effective in preventing unreasonable 
risk from the use of methylene chloride in consumer paint and coating 
removal. This final rule is informed by the TSCA Work Plan Chemical 
Risk Assessment Methylene Chloride: Paint Stripping Use, as well as 
information gathered from the comments on the proposed rulemaking, SBAR 
panel, and public meetings. For more information on the proposed 
rulemaking, SBAR panel and outreach efforts for this action, see the 
docket for this rulemaking (Docket ID Number EPA-HQ-OPPT-2016-0231).
    2. Significant comments on the IRFA. EPA received no comments on 
the IRFA. However, EPA did receive comments related to the regulatory 
options selected, alternative regulatory actions, and impacts on small 
businesses. The comments received on the proposed rule and EPA's 
responses as they relate to this final action are summarized in Unit 
II.B.3 and in further detail in the Response to Comment Document in the 
docket (Ref. 15).
    3. SBA Office of Advocacy comments and EPA response. EPA received 
no comments from SBA on the IRFA. SBA, however, did provide comments on 
the proposed rule. Because EPA is not finalizing the proposed 
regulations on NMP, EPA is not responding to the comments received 
regarding NMP at this time and will take them into consideration during 
the risk evaluation for that chemical. SBA's comments which pertain to 
methylene chloride consumer paint and coating removal, and EPA's 
responses, are in the Response to Comments document for this rule (Ref. 
15) and in the FRFA (Ref. 31).
    4. Estimate of the number of small entities to which the final rule 
applies. EPA estimates that this final rule would affect approximately 
7 small entities, specifically, a small number of formulators of paint 
and coating removal products that contain methylene chloride (Ref. 32). 
The cost to these small businesses will be the cost of reformulating 
products sold to consumer users and the cost of complying with the 
downstream notification requirements. In addition, cost impacts of a 
prohibition on sale of paint and coating remover products containing 
methylene chloride for consumer uses on retailers of such products is 
not included in this analysis, as EPA is uncertain about the effect of 
possible increased sales of alternative paint and coatings removal 
products. Some of the affected retailers may be small businesses and 
these retailers are not included in this discussion.
    Some small business may be negatively affected by the rule. 
Negative impacts may include increasing production of substitute 
chemicals to replace some of the production of methylene chloride, or 
updating SDS sheets, etc. EPA does not expect these impacts to be 
costly but as they are tasks that will take time, effort, and resources 
the firms would not otherwise expend in such a manner, EPA sees them as 
negative impacts on the firms. Another negative impact may include a 
small business formulator exiting the paint and coating removal product 
market entirely.
    5. Projected reporting, recordkeeping and other compliance 
requirements of the final rule. i. Compliance requirements. To address 
the unreasonable risks that EPA has identified for methylene chloride 
in consumer paint and coating removal, EPA is finalizing under section 
6 of TSCA regulations that prohibit the manufacture (including import), 
processing, and distribution in commerce of methylene chloride for all 
consumer paint and coating removal. The prohibition on distribution in 
commerce of methylene chloride in paint and coating removal for all 
consumer uses includes a prohibition on the distribution of methylene 
chloride for paint and coating removal to and by retailers. EPA is also 
requiring manufacturers (including importers), processors, and 
distributors, except for retailers, of methylene chloride for any use 
to provide downstream notification of these requirements and 
prohibitions throughout the supply chain via simple modifications to 
the SDS; and requiring limited recordkeeping.
    ii. Classes of small entities subject to the compliance 
requirements. The small entities that are potentially directly 
regulated by this rule are small entities that are formulators of paint 
and coating removal products that contain methylene chloride.
    iii. Professional skills needed to comply. For this rule, complying 
with the prohibitions, the downstream notification, and the 
recordkeeping requirements involve no special skills.
    6. Steps taken to minimize economic impact to small entities. i. 
Small Business Advocacy Review Panel. As required by section 609(b) of 
the RFA, EPA also convened an SBAR Panel during the development of the 
proposed rule to obtain advice and recommendations from small entity 
representatives that potentially would be subject to the rule's 
requirements. The SBAR Panel evaluated the assembled materials and 
small-entity comments on issues related to elements of an IRFA. A copy 
of the full SBAR Panel Report (Ref. 14) is available in the rulemaking 
docket. The Panel recommended that EPA seek additional information in 
five specific areas: Exposure information, regulatory options, 
alternatives, cost information, and risk assessment. The comments 
received on the proposed rule and EPA's responses as they pertain to 
consumer paint and coating removal are summarized in Unit II.B.3 and in 
further detail in the Response to Comments Document in the docket (Ref. 
15).
    ii. Alternatives considered. EPA considered a wide variety of risk 
reduction options. The primary alternative regulatory action would not 
include restrictions on manufacturing, processing, or distribution of 
methylene chloride for consumer paint and coating

[[Page 11434]]

removal, but it would require the distribution in commerce of methylene 
chloride for paint and coating removal in containers with volumes no 
less than 55 gallons, or 5 gallons for certain formulations. In 
addition, downstream notification and recordkeeping would be required. 
As required under TSCA section 6(c), EPA analyzed the costs and 
benefits of the alternative regulatory action (Ref. 4). EPA finds that 
the primary alternative regulatory action would introduce additional 
burdens to processors and distributors who would bear the costs of 
ensuring products are in 55 and 5-gallon containers, as appropriate. In 
addition, the 55-gallon volume restriction would effectively bar most 
commercial users in the professional contractor, bathtub refinishing, 
and graffiti removal sectors given the increased cost. The final rule 
is more cost effective than the primary alternative regulatory action 
considered. A summary of the findings of this analysis are in III.A.3 
and in the Economic Analysis (Ref. 4).
    7. Small Business Compliance Guides. EPA is preparing a Small 
Entity Compliance Guide to help small entities comply with this rule. 
EPA expects that this guide will be made available on the EPA website 
prior to the effective date of this final rule.

E. Unfunded Mandates Reform Act (UMRA)

    This action does not contain an unfunded mandate of $100 million or 
more as described in UMRA, 2 U.S.C. 1531-1538, and does not 
significantly or uniquely affect small governments. The requirements of 
this action would primarily affect manufacturers, processors, and 
distributors of methylene chloride. The total estimated annualized cost 
of this final rule are $3.8 to $13.6 million and $3.8 to $13.7 million 
annualized over 20 years at 3% and 7%, respectively (Ref. 4), which 
does not exceed the inflation-adjusted unfunded mandate threshold of 
$154 million.

F. Executive Order 13132: Federalism

    EPA has concluded that this action does not have federalism 
implications, as specified in Executive Order 13132 (64 FR 43255, 
August 10, 1999). This regulation will not preempt state law. 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. 
Neither pause preemption nor permanent preemption apply to the 
restrictions proposed or to this final regulation, because this TSCA 
section 6(a) rule is promulgated under TSCA section 26(l)(4). In 
accordance with section 26(l)(4), this rulemaking is consistent with 
the scope of the 2014 risk assessment of methylene chloride for paint 
and coating removal, as well as other applicable requirements of TSCA 
section 6, and is not based on a risk evaluation conducted under TSCA 
section 6(b). Therefore, EPA believes that this rule will not preempt a 
state law or action on methylene chloride for consumer paint and 
coating removal under either section 18(a)(1)(B) (under which the 
extent of permanent preemption is ``consistent with the scope of the 
risk evaluation under section (6)(b)(4)(D)'') or section 18(b) (under 
which the extent of pause preemption is tied to the ``scope of the risk 
evaluation pursuant to section 6(b)(4)(D)'').
    Although this rule does not have federalism implications, the 
Agency consulted with state and local officials early in the process of 
developing the proposed action to permit them to have meaningful and 
timely input into its development. EPA invited the following national 
organizations representing state and local elected officials to a 
meeting on May 13, 2015, in Washington DC: National Governors 
Association; National Conference of State Legislatures, Council of 
State Governments, National League of Cities, U.S. Conference of 
Mayors, National Association of Counties, International City/County 
Management Association, National Association of Towns and Townships, 
County Executives of America, and Environmental Council of States. A 
summary of the meeting with these organizations, including the views 
that they expressed, is available in the docket (Ref. 33).

G. Executive Order 13175: Consultation and Coordination With Indian 
Tribal Governments

    This action does not have tribal implications, as specified in 
Executive Order 13175 (65 FR 67249, November 9, 2000). This rulemaking 
would not have substantial direct effects on tribal government because 
methylene chloride is not manufactured, processed, or distributed in 
commerce by tribes. EPA did not receive any information during the 
public comment period to alter EPA's understanding that this action has 
no substantial direct effects on tribal governments. Tribes do not 
regulate methylene chloride, and this rulemaking would not impose 
substantial direct compliance costs on tribal governments. Thus, E.O. 
13175 does not apply to this action. EPA nevertheless consulted with 
tribal officials during the development of this action, consistent with 
the EPA Policy on Consultation and Coordination with Indian Tribes 
(Ref. 34).

H. Executive Order 13045: Protection of Children From Environmental 
Health Risks and Safety Risks

    This action is not subject to Executive Order 13045 (62 FR 19885, 
April 23, 1997) because it is not economically significant as defined 
in Executive Order 12866, and because EPA does not believe the 
environmental health or safety risks addressed by this action present a 
disproportionate risk to children. This action's health and risk 
assessment of exposure by children to methylene chloride in paint and 
coating removal is contained in the proposed rule (Ref. 3 at pp. 7462, 
7476, and 7503). Supporting information on methylene chloride exposures 
and the health effects of methylene chloride exposure by children is 
available in the Toxicological Review of Methylene Chloride (Ref. 5) 
and the methylene chloride risk assessment (Ref. 2).

I. Executive Order 13211: Actions Concerning Regulations That 
Significantly Affect Energy Supply, Distribution in Commerce, or Use

    This final rule is not subject to Executive Order 13211 (66 FR 
28355, May 22, 2001), because this action is not expected to affect 
energy supply, distribution in commerce, or use. This rule is intended 
to protect against risks from methylene chloride in paint and coating 
removal, and does not affect the use of oil, coal, or electricity.

J. National Technology Transfer and Advancement Act (NTTAA)

    This final rule does not involve technical standards, and is 
therefore not subject to considerations under NTTAA section 12(d), 15 
U.S.C. 272.

K. Executive Order 12898: Federal Actions To Address Environmental 
Justice in Minority Populations and Low-Income Populations

    Executive Order 12898 (59 FR 7629, February 16, 1994) establishes 
Federal executive policy on environmental justice. Its main provision 
directs Federal agencies, to the greatest extent practicable and 
permitted by law, to make environmental justice part of their mission 
by identifying and addressing, as appropriate, disproportionately high 
and adverse health or environmental effects of their programs, policies 
and activities on minority populations and low-income populations in 
the U.S. EPA places particular emphasis on the public

[[Page 11435]]

health and environmental conditions affecting minority populations, 
low-income populations, and indigenous peoples. In recognizing that 
these populations frequently bear a disproportionate burden of 
environmental harms and risks, EPA works to protect them from adverse 
public health and environmental effects (Ref. 35).

L. Congressional Review Act (CRA)

    This action is subject to the CRA, and the EPA will submit a rule 
report to each House of the Congress and to the Comptroller General of 
the United States. This action is not a ``major rule'' as defined by 5 
U.S.C. 804(2).

List of Subjects in 40 CFR Part 751

    Environmental protection, Chemicals, Export notification, Hazardous 
substances, Import certification, Reporting and recordkeeping 
requirements.

    Dated: March 15, 2019.
Andrew Wheeler,
Administrator.

0
Therefore, add 40 CFR part 751 to read as follows:

PART 751--REGULATION OF CERTAIN CHEMICAL SUBSTANCES AND MIXTURES 
UNDER SECTION 6 OF THE TOXIC SUBSTANCES CONTROL ACT

Subpart A--General Provisions
Sec.
751.1 Purpose.
751.5 Definitions.
751.7 Exports and imports.
751.9 Enforcement and inspections.
Subpart B--Methylene Chloride
751.101 General.
751.103 Definitions.
751.105 Consumer paint and coating removal.
751.107 Downstream notification.
751.109 Recordkeeping.
Subpart C--[Reserved]

    Authority: 15 U.S.C. 2605, 15 U.S.C. 2625(l)(4).

Subpart A--General Provisions


Sec.  751.1   Purpose.

    This part sets forth requirements under section 6(a) of the Toxic 
Substances Control Act, 15 U.S.C. 2605(a), regulating the manufacture 
(including import), processing, distribution in commerce, use, or 
disposal of certain chemical substances and mixtures in order to 
address unreasonable risks to the extent necessary so that the chemical 
substance or mixture no longer presents such risk.


Sec.  751.5   Definitions.

    The definitions in section 3 of the Toxic Substances Control Act, 
15 U.S.C. 2602, apply to this part except as otherwise established in 
any subpart under this part.
    Act or TSCA means the Toxic Substances Control Act, 15 U.S.C. 2601 
et seq.
    CASRN means Chemical Abstracts Service Registry Number.
    EPA means the U.S. Environmental Protection Agency.
    Person means any natural person, firm, company, corporation, joint 
venture, partnership, sole proprietorship, association, or any other 
business entity; any State or political subdivision thereof; any 
municipality; any interstate body; and any department, agency, or 
instrumentality of the Federal government.


Sec.  751.7   Exports and imports.

    (a) Exports. Persons who intend to export a chemical substance 
identified in any subpart under this part are subject to the export 
notification provisions of section 12(b) of the Act. The regulations 
that interpret section 12(b) appear at 40 CFR part 707, subpart D.
    (b) Imports. Persons who import a substance identified in any 
subpart under this part are subject to the import certification 
requirements under section 13 of the Act, which are codified at 19 CFR 
12.118 through 12.127. See also 19 CFR 127.28.


Sec.  751.9   Enforcement and inspections.

    (a) Enforcement. (1) Failure to comply with any provision of this 
part is a violation of section 15 of the Act (15 U.S.C. 2614).
    (2) Failure or refusal to establish and maintain records or to 
permit access to or copying of records, as required by the Act, is a 
violation of section 15 of the Act (15 U.S.C. 2614).
    (3) Failure or refusal to permit entry or inspection as required by 
section 11 of the Act (15 U.S.C. 2610) is a violation of section 15 of 
the Act (15 U.S.C. 2614).
    (4) Violators may be subject to the civil and criminal penalties in 
section 16 of the Act (15 U.S.C. 2615) for each violation.
    (b) Inspections. EPA may conduct inspections under section 11 of 
the Act (15 U.S.C. 2610) to ensure compliance with this part.

Subpart B--Methylene Chloride


Sec.  751.101  General.

    This subpart sets certain restrictions on the manufacture 
(including import), processing, and distribution in commerce of 
methylene chloride (CASRN 75-09-2) for consumer paint and coating 
removal to prevent unreasonable risks of injury to health due to acute 
human lethality.


Sec.  751.103  Definitions.

    The definitions in subpart A of this part apply to this subpart 
unless otherwise specified in this section. In addition, the following 
definitions apply:
    Consumer paint and coating removal means paint and coating removal 
performed by any natural person who uses a paint and coating removal 
product for any personal use without receiving remuneration or other 
form of payment.
    Distribute in commerce has the same meaning as in section 3 of the 
Act, except that the term does not include retailers for purposes of 
Sec. Sec.  751.107 and 751.109.
    Paint and coating removal means application of a chemical or use of 
another method to remove, loosen, or deteriorate any paint, varnish, 
lacquer, graffiti, surface protectants, or other coating from a 
substrate, including objects, vehicles, architectural features, or 
structures.
    Retailer means a person who distributes in commerce or makes 
available a chemical substance or mixture to consumer end users, 
including e-commerce internet sales or distribution. Any distributor 
with at least one consumer end user customer is considered a retailer. 
A person who distributes in commerce or makes available a chemical 
substance or mixture solely to commercial or industrial end users or 
solely to commercial or industrial businesses is not considered a 
retailer.


Sec.  751.105   Consumer paint and coating removal.

    (a) After November 22, 2019, all persons are prohibited from 
manufacturing, processing and distributing in commerce methylene 
chloride for consumer paint and coating removal.
    (b) After November 22, 2019, all persons are prohibited from 
distributing in commerce methylene chloride, including any methylene 
chloride containing products, for paint and coating removal to 
retailers.
    (c) After November 22, 2019, all retailers are prohibited from 
distributing in commerce methylene chloride, including any methylene 
chloride containing products, for paint and coating removal.

[[Page 11436]]

Sec.  751.107  Downstream notification.

    Each person who manufactures, processes, or distributes in commerce 
methylene chloride for any use after August 26, 2019 must, prior to or 
concurrent with the shipment, notify companies to whom methylene 
chloride is shipped, in writing, of the restrictions described in this 
subpart. Notification must occur by inserting the following text in the 
Safety Data Sheet (SDS) provided with the methylene chloride or with 
any methylene chloride containing product:
    (a) SDS Section 1.(c): ``This chemical/product is not and cannot be 
distributed in commerce (as defined in TSCA section 3(5)) or processed 
(as defined in TSCA section 3(13)) for consumer paint or coating 
removal.''
    (b) SDS Section 15: ``This chemical/product is not and cannot be 
distributed in commerce (as defined in TSCA section 3(5)) or processed 
(as defined in TSCA section 3(13)) for consumer paint or coating 
removal.''


Sec.  751.109  Recordkeeping.

    (a) Each person who manufactures, processes, or distributes in 
commerce any methylene chloride after August 26, 2019 must retain in 
one location at the headquarters of the company, or at the facility for 
which the records were generated, documentation showing:
    (1) The name, address, contact, and telephone number of companies 
to whom methylene chloride was shipped;
    (2) A copy of the notification provided under Sec.  751.107; and
    (3) The amount of methylene chloride shipped.
    (b) The documentation in paragraph (a) of this section must be 
retained for 3 years from the date of shipment.

Subpart C--[Reserved]

[FR Doc. 2019-05666 Filed 3-26-19; 8:45 am]
 BILLING CODE 6560-50-P


