[Federal Register Volume 82, Number 12 (Thursday, January 19, 2017)]
[Proposed Rules]
[Pages 7464-7533]
[FR Doc No: 2017-01222]

Vol. 82

Thursday,

No. 12

January 19, 2017

Part XV

 Environmental Protection Agency

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40 CFR Part 751

 Methylene Chloride and N-Methylpyrrolidone; Regulation of Certain Uses
Under TSCA Section 6(a); Proposed Rule

Federal Register / Vol. 82 , No. 12 / Thursday, January 19, 2017 /
Proposed Rules

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 751

[EPA-HQ-OPPT-2016-0231; FRL-9958-57]
RIN 2070-AK07

Methylene Chloride and N-Methylpyrrolidone; Regulation of Certain
Uses Under TSCA Section 6(a)

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: Methylene chloride, also called dichloromethane, is a volatile
chemical that has a variety of uses, including paint and coating
removal. N-methylpyrrolidone (NMP) is a solvent used in a variety of
applications, including paint and coating removal. For each of these
chemicals, EPA has identified risks of concern associated with their
use in paint and coating removal. EPA proposes a determination that
these are unreasonable risks. EPA is proposing to prohibit the
manufacture (including import), processing, and distribution in
commerce of methylene chloride for consumer and most types of
commercial paint and coating removal under section 6 of the Toxic
Substances Control Act (TSCA). EPA is also proposing to prohibit the
use of methylene chloride in these commercial uses; to require
manufacturers (including importers), processors, and distributors,
except for retailers, of methylene chloride for any use to provide
downstream notification of these prohibitions throughout the supply
chain; and to require recordkeeping. EPA is proposing an initial ten-
year time-limited exemption from these proposed regulations on
methylene chloride for coating removal uses critical for national
security. First, EPA is proposing to prohibit the manufacture
(including import), processing, and distribution in commerce of NMP for
all consumer and commercial paint and coating removal; to prohibit the
use of NMP for all commercial paint and coating removal; to require,
consistent with methylene chloride restrictions, downstream
notification of these prohibitions throughout the supply chain; to
require recordkeeping; and to provide a time-limited exemption from
these proposed regulations on NMP for coating removal uses critical for
national security. For NMP, as an alternate proposal, EPA is proposing
that (1) commercial users of NMP for paint and coating removal
establish a worker protection program for dermal and respiratory
protection and not use paint and coating removal products that contain
greater than 35 percent NMP by weight (except for product formulations
destined to be used by DoD or its contractors performing work only for
DOD projects); and (2) processors of products containing NMP for paint
and coating removal reformulate products such that these products do
not exceed a maximum of 35 percent NMP by weight, identify gloves that
provide effective protection for the formulation, and provide warning
and instruction labels on the products.

DATES: Comments must be received on or before April 19, 2017.

ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPPT-2016-0231, at http://www.regulations.gov.
Follow the online instructions for submitting comments. Once submitted,
comments cannot be edited or withdrawn. EPA may publish any comment
received to its public docket. Do not submit electronically any
information you consider to be Confidential Business Information (CBI)
or other information whose disclosure is restricted by statute.
Multimedia submissions (audio, video, etc.) must be accompanied by a
written comment. The written comment is considered the official comment
and should include discussion of all points you wish to make. EPA will
generally not consider comments or comment contents located outside of
the primary submission (i.e., on the web, cloud, or other file sharing
system). For additional submission methods (e.g., mail or hand
delivery), the full EPA public comment policy, information about CBI or
multimedia submissions, and general guidance on making effective
comments, please visit http://www2.epa.gov/dockets/commenting-epa-dockets.
    Docket. Docket number EPA-HQ-OPPT-2016-0231 contains supporting
information used in developing the proposed rule, comments on the
proposed rule, and additional supporting information. 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: Ana
Corado, Chemical Control Division, Office of Pollution Prevention and
Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave. NW.,
Washington, DC 20460-0001; telephone number<PHONE_NUMBER>; email
address<EMAIL_ADDRESS>For other information contact: Niva
Kramek, Chemical Control Division, Office of Pollution Prevention and
Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave. NW.,
Washington, DC 20460-0001; telephone number:<PHONE_NUMBER>; email
address<EMAIL_ADDRESS>    For general information contact: The TSCA-Hotline, ABVI-Goodwill,
422 South Clinton Ave., Rochester, NY 14620; telephone number: (202)
554-1404; email address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Executive Summary

A. Does this action apply to me?

    You may potentially be affected by this proposed action if you
manufacture (defined under Toxic Substances Control Act (TSCA) to
include import), process, distribute in commerce, or use methylene
chloride or NMP for paint and coating removal. Paint and coating
removal, also referred to as paint stripping, is the process of
removing paint or other coatings from a surface. 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).
 Ship building and repairing (NAICS code 336611)
 Aircraft manufacturing (NAICS code 336411)
 Museums (NAICS code 712110)
 Independent Artists, Writers, and Performers (NAICS code
711510)
 Reupholster and furniture repair (NAICS code 811420)
 Automotive body, paint, and interior repair and maintenance
(NAICS code 811121)
 Flooring contractors (NAICS code 238330)
 Painting and wall covering contractors (NAICS code 238320)

    This action may also affect certain entities through pre-existing
import certification and export notification rules under TSCA. Persons
who import any chemical substance governed by a final TSCA section 6(a)
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 the shipment of the chemical substance 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 that is the subject of this proposed rule 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
proposed 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
after risk evaluation 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 to the risk evaluation, 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)) expressly authorizes EPA to issue rules
under TSCA section 6(a) that are consistent with the scope of the
completed risk assessment and consistent with the other applicable
requirements of TSCA section 6. Methylene chloride and NMP are such
chemical substances (Ref. 1). They are listed in the 2014 update to the
TSCA Work Plan and the completed risk assessments were published in
2014 and 2015, respectively. The scope of each completed risk
assessment includes consumer and commercial paint and coating removal.

C. What action is the Agency taking?

    EPA proposes a determination that the uses of methylene chloride or
NMP in paint and coating removal present an unreasonable risk of injury
to health. Accordingly, for methylene chloride, EPA is proposing under
section 6 of TSCA to prohibit the manufacture (including import),
processing, and distribution in commerce of methylene chloride for all
consumer and for most types of commercial paint and coating removal
uses. EPA is also proposing under TSCA section 6 to prohibit the use of
methylene chloride for commercial paint and coating removal in the
specified sectors, which include painting and decorating, floor
refinishing, automotive refinishing, civilian aircraft refinishing,
graffiti removal, renovations and contracting, bridge repair and
repainting, and marine craft refinishing and repair. EPA is not
proposing at this time to regulate the use of methylene chloride in
commercial furniture refinishing, also referred to as furniture
stripping or refinishing conducted by professionals or commercial
workers. EPA is also proposing to exempt certain uses of methylene
chloride for coating removal that EPA proposes are critical for
national security.
    EPA is also proposing to require that any paint or coating removal
products containing methylene chloride that continue to be distributed
be packaged in containers with a volume no less than 55 gallons, except
for formulations specifically manufactured for the Department of
Defense, which may be distributed in containers with volumes no less
than 5 gallons. EPA is also proposing to require 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; and to require limited recordkeeping. More details on
this supply chain approach are in Unit VI.C.3.
    EPA intends to issue a separate proposal on methylene chloride in
paint and coating removal in commercial furniture refinishing, but
plans to issue one final rule covering both this proposal and the
future proposed rule on methylene chloride in paint and coating removal
in commercial furniture refinishing. More information on such a future
proposal that would directly address methylene chloride in paint and
coating removal in furniture refinishing is in Unit XI.
    For NMP, EPA is co-proposing two different options to reduce the
unreasonable risks presented by NMP in paint and coating removal for
consumers and commercial users. EPA is co-proposing these two options
because the Agency is interested in public consideration of these
approaches, and is soliciting comments regarding the extent to which
these approaches could reduce the unreasonable risks the Agency has
identified.
    Under the first approach co-proposed for NMP (option 1), EPA is
proposing to prohibit the manufacture (including import), processing,
and distribution in commerce of NMP for all consumer and commercial
paint and coating removal, with exemptions for certain coating removal
uses that EPA proposes are critical to national security. EPA is also
proposing to prohibit the commercial use of NMP for paint and coating
removal, with exemptions for certain coating removal uses that EPA
proposes are critical to national security. These exemptions include
the condition that any exempt paint and coating removal products
containing NMP be packaged in containers with a volume no less than 5
gallons. Unlike the option proposed for methylene chloride, these
exemptions do not include the use of NMP in furniture refinishing. EPA
is also proposing to require manufacturers (including importers),
processors, and distributors, except for retailers, of NMP for any use
to provide downstream notification of these prohibitions throughout the
supply chain; and to require limited recordkeeping.
    Under the second approach proposed for NMP, EPA is proposing a
reformulation, PPE, and labeling approach. This would require product
reformulation to limit the concentration of NMP in paint and coating
removal products; testing of product formulations to identify
specialized gloves that provide protection; relabeling of products to
provide additional information to consumers; an occupational dermal and
respiratory protection program for commercial use of NMP in paint and
coating removal, downstream notification when distributing NMP for
other uses, and limited recordkeeping. Under this approach, no
exemption is proposed for coating removal identified as critical for
national security because paint and coating removal products containing
NMP would continue to be available for these national security uses
under this option, even without establishing a national security
exemption.
    EPA is requesting public comment on these proposals.

D. Why is the Agency taking this action?

    Based on EPA's analysis of worker and consumer populations'
exposures to methylene chloride and NMP in paint and coating removal,
EPA proposes a determination that methylene chloride and NMP in paint
and coating removal present an unreasonable risk to human

health. For methylene chloride, the health impacts of its use in paint
and coating removal include death (due to asphyxiation), liver
toxicity, kidney toxicity, reproductive toxicity, specific cognitive
impacts, and cancers such as brain cancer, liver cancer, certain lung
cancers, non-Hodgkin's lymphoma, and multiple myeloma (Ref. 2). Some of
these effects result from a very short, acute exposure; others follow
years of occupational exposure. For NMP, these health effects include
developmental toxicity (e.g., fetal death or decreased infant birth
weight), neurotoxicity, immunotoxicity, liver and kidney toxicity, and
reproductive toxicity (Ref. 3).
    It is important to note that while both methylene chloride and NMP
are used in paint and coating removal, products containing NMP have in
recent years become increasingly popular substitutes for users
interested in avoiding the health effects or odors known to be
associated with products containing methylene chloride. While exposures
to these chemicals have been assessed using different health endpoints,
EPA proposes a determination that the use of either methylene chloride
or NMP in paint and coating removal presents unreasonable risks. For
this reason, EPA proposes to address the unreasonable risks presented
by both chemicals in one rule.
    Although EPA proposes to determine that the identified risks to
workers exposed to methylene chloride in commercial furniture
refinishing are unreasonable, EPA is not proposing to regulate these
risks at this time. EPA intends to issue a separate proposal addressing
the use of methylene chloride in paint and coating removal in
commercial furniture refinishing. See Unit XI.
    As discussed in Unit V.C., EPA is not proposing to prohibit all
manufacturing, processing, distribution in commerce, and use of
methylene chloride or NMP, of which paint and coating removal is
estimated to comprise 25% and 9% of the use of each chemical,
respectively (Refs. 2 and 3).

E. What are the estimated incremental impacts of this action?

    EPA proposes to determine that the identified risks from methylene
chloride and NMP in paint and coating removal are unreasonable. Apart
from that proposed determination, EPA has evaluated the potential costs
of the proposed approach of (1) prohibiting the manufacture (including
import), processing, and distribution in commerce of methylene chloride
for all consumer paint and coating removal in the sectors specified in
section I.C of this preamble, exempting specific uses critical to
national security; (2) prohibiting the commercial use of methylene
chloride for paint and coating removal in the specified sectors; (3)
requiring any paint and coating removal products containing methylene
chloride to be packaged for distribution in commerce in containers with
volumes no less than 55 gallons so as to reduce diversion to restricted
uses, except for formulations specifically manufactured for the
Department of Defense; (4) requiring manufacturers (including
importers), processors, and distributors, except for retailers, to
provide downstream notification of these prohibitions throughout the
supply chain; and (5) requiring associated recordkeeping requirements.
EPA has also evaluated the costs of the two co-proposed options for
NMP. Under the first option, this includes (1) prohibiting the
manufacture (including import), processing, and distribution in
commerce of NMP for all paint and coating removal, exempting specific
uses critical to national security; (2) prohibiting the commercial use
of NMP for paint and coating removal exempting specific uses critical
to national security; (3) requiring any paint and coating removal
products containing NMP to be packaged for distribution in commerce in
containers with a volume no less than 5 gallons; (4) requiring
manufacturers (including importers), processors, and distributors of
NMP for any use, except for retailers, to provide downstream
notification of these prohibitions throughout the supply chain; and (5)
requiring associated recordkeeping requirements. Under the second
option, this includes: (1) Prohibiting the manufacture, processing, and
distribution in commerce of paint and coating removal products
containing more than 35 percent NMP by weight except for products used
for critical national security uses; (2) Requiring product formulators
to test gloves for the product formulations being processed and
distributed in commerce for other than exempt critical national
security uses to identify specialized gloves that provide protection
for users and keep records relevant to these tests; (3) Requiring
product formulators to label products with information for consumers
about the risks presented by the products and how to reduce these risks
during use, including identifying which specialized gloves provide
protection against the specific formulation; (4) Requiring product
formulators to provide information for commercial users about reducing
risks when using the product, via product labels, SDS, and other
methods of hazard communication, and to keep records; (5) Prohibiting
the commercial use of paint and coating removal products that contain
more than 35 percent by weight of NMP, except for critical national
security uses; and (6) Requiring commercial users to establish worker
protection programs for dermal and respiratory protection, including
hazard communication and training, and to require their employees to
wear specialized gloves, impervious clothing that covers most of the
body, and a respirator with an assigned protection fact (APF) of 10 or
compliance with an alternative air exposure limit.
    This analysis, which is available in the docket, is discussed in
Units VII.A. and XVII.A., and is briefly summarized here.
    Costs of the proposed approach and relevant alternate approaches
for each chemical are discussed in Units VII.A. for methylene chloride
and XVII.A. for NMP. Costs for the whole proposal follow. Costs to
users of methylene chloride or NMP for paint and coating removal under
the first co-proposed approach for NMP are $2,517,000 to $50,801,000
annualized for 20 years at a discount rate of 3% and $3,114,000 to
$50,916,000 at a discount rate of 7%. Costs to users of methylene
chloride or NMP for paint and coating removal under the second co-
proposed approach for NMP are $114,164,860 to $124,893,000 annualized
for 20 years at a discount rate of 3% and $114,658,000 to $125,438,000
at a discount rate of 7%. As described in more detail in the Economic
Analysis (Ref. 4) and supplement to the Economic Analysis (Ref. 127),
there are estimated to be approximately 13,000 commercial firms and
2,002,000 consumers who use methylene chloride or NMP in paint and
coating removal that would be affected; costs per firm and for each
household are estimated to include costs of alternative formulations of
paint removal products, additional time spent applying or removing
paint with alternative methods or substitute products, and other cost
factors. For product processors and formulators, the costs of paint and
coating removal product reformulations for methylene chloride and NMP
under the first co-proposed approach for NMP are estimated to be
approximately $17,000 to $34,000 per year (annualized at 3% over 20
years) and $23,000 to $43,000 (annualized at 7% over 20 years). For
product processors and formulators, the costs of paint and coating
removal product reformulations for methylene

chloride and NMP under the second co-proposed approach for NMP are
estimated to be approximately $25,140 to $41,140 per year (annualized
at 3% over 20 years) and $34,160 to $55,160 (annualized at 7% over 20
years). Only 17 firms are estimated to be affected. For manufacturers,
processors, and distributors of methylene chloride or NMP under the
first co-proposed approach for NMP, the costs of downstream
notification and recordkeeping on an annualized basis over 20 years are
$140 and $160 using 3% and 7% discount rates respectively. For
manufacturers, processors, and distributors of methylene chloride or
NMP under the second co-proposed approach for NMP, the costs of
downstream notification and recordkeeping on an annualized basis over
20 years are $140 and $160 using 3% and 7% discount rates respectively
(the same as under the first co-proposed approach). Approximately 30
firms are estimated to be affected. Agency costs for enforcement for
each chemical, under the first co-proposed approach for NMP, are
estimated to be approximately $114,401 and $111,718 annualized over 20
years at 3% and 7%, respectively (Ref. 4). Total Agency costs for
enforcement, for both chemicals together under the first co-proposed
approach for NMP, are estimated to be approximately $228,802 and
$223,436 annualized over 20 years at 3% and 7%. Agency costs for
enforcement for each chemical, under the second co-proposed approach
for NMP, are estimated to be approximately $114,401 and $111,718
annualized over 20 years at 3% and 7%, respectively for methylene
chloride and $1,024,144 and $998,711 annualized over 20 years at 3% and
7% respectively for NMP (Ref. 127). Total Agency costs for enforcement,
for both chemicals together under the second co-proposed approach for
NMP, are estimated to be approximately $1,138,545 and $1,110,429
annualized over 20 years at 3% and 7%.
    In summary, total costs of the proposed rule under the first co-
proposed approach for NMP are estimated to be $2,763,000 to $51,070,000
annualized over 20 years at 3% and $3,361,000 to $51,163,000 annualized
over 20 years at 7% (Ref. 4). Total costs of the proposed rule under
the second co-proposed approach for NMP are estimated to be
$114,196,000 to $124,893,000 annualized over 20 years at 3% and
$114,658,000 to $125,438,000 annualized over 20 years at 7% (Ref. 127).
    Although methylene chloride in paint and coating removal can cause
a wide range of non-cancer adverse effects, cancer, and death and NMP
can cause a variety of developmental non-cancer adverse effects,
monetized benefits included only the subset of benefits associated with
reducing cancer risks or deaths that occur at a known rate among users
or bystanders. Methodological limitations prevent EPA from being able
to include a quantification or monetary valuation estimate of the other
non-cancer benefits at this time, and thus there is not a
quantification or monetary valuation estimate for the overall total
benefits. Based on the costs and benefits that EPA can estimate, the
monetized benefits for the proposed approach range from approximately
$14,354,000 to $14,558,000 on an annualized basis over 20 years at 3%
and $13,791,000 to $13,919,000 at 7% (Ref. 4). EPA also considered non-
monetized benefits that would result from the prevention of non-cancer
adverse effects associated with methylene chloride or NMP in paint and
coating removal, including nervous system effects, liver toxicity,
kidney toxicity, and reproductive effects from exposure to methylene
chloride in paint and coating removal; and developmental toxicity,
fetal death, fetal body weight reductions, kidney toxicity, liver
toxicity, immunotoxicity, and reproductive toxicity from exposure to
NMP in paint and coating removal (Refs. 2 and 3).

F. Children's Environmental Health

    This action is consistent with the 1995 EPA Policy on Evaluating
Health Risks to Children (http://www.epa.gov/children/epas-policy-evaluating-risk-children). In its risk assessments for methylene
chloride and NMP, EPA identified risks to children from exposure to
methylene chloride and NMP used in paint and coating removal. EPA has
also identified women of childbearing age as a potentially exposed or
susceptible subpopulation who may be at greater risk than the general
population of adverse health effects from exposure to NMP. EPA has
identified this subpopulation as relevant to EPA's risk assessment for
NMP due to NMP's effects on the developing fetus. Therefore, the risk
management standard under Section 6 of TSCA, with respect to NMP, is to
reduce the risk posed by NMP so that it no longer presents an
unreasonable risk (either to users in the general population or to
users who are women of childbearing age). 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
paint removal occurs. These risks include neurological effects such as
cognitive impairment, sensory impairment, dizziness, incapacitation,
and loss of consciousness (leading to risks of falls, concussion, and
other injuries). The supporting non-cancer risk analysis of children as
bystanders conducted in the TSCA Work Plan Risk Assessment for
methylene chloride meets the 1995 EPA Policy on Evaluating Health Risks
to Children. 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 Units VI.C.1. and VI.D.
    In the TSCA Work Plan Risk Assessment for NMP, EPA identified
developmental toxicity as the most sensitive endpoint for NMP exposure
(i.e., fetal death and decreased fetal birth weight) for the most
sensitive human life stages (i.e., women of childbearing age between
the ages of 16 and 49 years and the fetus) (Ref. 3). The supporting
non-cancer risk analysis of children and women of childbearing age
conducted in the TSCA Work Plan Risk Assessment for NMP meets the 1995
EPA Policy on Evaluating Health Risks to Children.

II. Overview of Methylene Chloride and Uses Subject to This Proposed
Rule

A. What chemical is included in the proposed rule?

    This proposed rule would apply to methylene chloride (CASRN 75-09-
2) when used in paint and coating removal except for several specified
uses, including as part of commercial furniture refinishing and uses
critical to national security.

B. What are the uses of methylene chloride?

    Methylene chloride is a solvent used in a variety of industrial,
commercial and consumer use applications, including (Ref. 2):

 Paint remover
 Adhesive
 Aerosol propellant
 Metal cleaner and degreaser
 Chemical processor for polycarbonate resins and cellulose
triacetate (photographic film)
 Feedstock in the production of the refrigerant
hydrofluorocarbon-32

    Minor uses of methylene chloride include (Ref. 2):
 Extraction solvent for oils, waxes, fats, spices, and hops
 Tablet coating for pharmaceuticals

    According to the 2012 Chemical Data Reporting (CDR) information,
approximately 260 million pounds of

methylene chloride were produced or imported into the United States
that year, with between 80% to 96% produced in the United States (Ref.
2). In terms of environmental releases, 277 facilities reported a total
of 3.2 million pounds of releases of methylene chloride to the 2014
Toxics Release Inventory (Ref. 6).
    Individuals, including workers, consumers, and the general
population, 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).
    The use assessed by EPA that is the subject of this proposal,
methylene chloride in paint and coating removal, represents about 25%
of total use of methylene chloride. This is a decrease from the 1980s,
when approximately 50% of the total methylene chloride market was
composed of paint removal use (Ref. 2). Paint and coating removal is
the application of a chemical or use of another method to remove,
loosen, or deteriorate any paint, varnish, lacquer, graffiti, surface
protectants, or other coatings from a substrate. Substrates can include
objects, vehicles, architectural features, or structures. This use is
discussed in detail in Unit VI.B.
    Although the TSCA Work Plan Chemical risk assessment for methylene
chloride focused on the chemical's use in paint and coating removal,
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). The Agency is
proceeding with this proposed rule addressing methylene chloride in
paint and coating removal in accordance with TSCA section 26(l) and
asks for comment on its decision to pursue risk management for specific
conditions of use of methylene chloride while preparing to conduct a
risk evaluation of remaining conditions of use of methylene chloride
under TSCA section 6(b).

C. What are the potential health effects of methylene chloride?

    Methylene chloride is a likely human carcinogen, a neurotoxicant,
and acutely lethal. Acute and chronic exposures to methylene chloride
are primarily associated with neurological and hepatic effects. 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. Carbon monoxide is one of the metabolic
byproducts of methylene chloride, and reversibly binds to hemoglobin as
carboxyhemoglobin. Part of the effect of methylene chloride on the
central nervous system comes from the accumulation of carboxyhemoglobin
in the blood, which can lead to sensory impairment, dizziness,
incapacitation, loss of consciousness, heart failure, and death (Ref.
2). Hemoglobin in the fetus has a higher affinity for carbon monoxide
than does adult hemoglobin. Thus, 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).
    During acute exposures, methylene chloride primarily affects the
brain, though effects on lung, liver, and kidney have also been
reported in humans following acute exposures. Acute exposures to
methylene chloride can be fatal; acute lethality in humans following
inhalation exposure is related to central nervous system depressant
effects. Effects include loss of consciousness and respiratory
depression, resulting in irreversible coma, hypoxia, and eventual
death. Acute non-lethal effects in humans are similarly related to the
central nervous system and can include incapacitation, loss of
consciousness, heart failure, and coma. Other acute non-lethal effects
in humans include neurobehavioral deficits measured in psychomotor
tasks, such as tests of hand-eye coordination, visual evoked response
changes, and auditory vigilance (Ref. 2).
    Since 1976, more than 40 deaths have been attributed to methylene
chloride when used in paint and coating removal (Ref. 7); in some
cases, two or more individuals have died during a single job when air
concentrations quickly reached lethal levels, potentially in less than
10 minutes. In other situations, individuals have died when entering
rooms or facilities in which paint or coating removal was previously
conducted and air concentrations of methylene chloride remained
dangerously high (Ref. 7).
    Chronic exposures to methylene chloride are associated with cancer
and non-cancer hepatic effects. Methylene chloride is likely to be
carcinogenic in humans with a mutagenic mode of action. This mutagenic
mode of action is supported by the weight of evidence from multiple in
vivo and in vitro studies. There is a risk for some specific cancers,
including brain cancer, liver cancer, non-Hodgkin lymphoma, and
multiple myeloma. Additionally, several cancer bioassays in animals
have identified the liver and lung as the most sensitive target organs
for tumor development induced by methylene chloride (Ref. 2).
    Non-cancer effects of chronic exposure to methylene chloride are
primarily hepatic; the liver is the most sensitive target for non-
cancer toxicity. Lifetime exposure in rats dosed with different
concentrations is associated with hepatic vacuolation, degeneration, or
liver necrosis. Other non-cancer effects of chronic methylene chloride
exposure include renal tubular degeneration in rats and mice,
testicular atrophy in mice, and ovarian atrophy in mice (Ref. 2).

D. What are the environmental impacts of methylene chloride?

    Pursuant to TSCA section 6(c), EPA in this unit describes the
effects of methylene chloride on the environment and the magnitude of
the exposure of the environment to methylene chloride. The proposed
unreasonable risk determination, however, is based solely on risks to
human health since these risks are the most serious consequence of use
of methylene chloride and are sufficient to support this proposed
action.
    1. Environmental effects and impacts. Methylene chloride is mainly
released to the environment in air, and to a lesser extent in water and
soil, due to industrial and consumer uses as a solvent, in aerosol
products, and in paint and coating removal. Many chemical waste sites
contain methylene chloride and these might act as additional sources of
environmental contamination through spills, leaks, or evaporation.
Because methylene chloride evaporates readily, most releases enter the
air. In the air, it is broken down by sunlight and by reaction with
other chemicals present in the air. In the air, methylene chloride's
half-life is between 53 to 127 days (Ref. 8).
    Ecotoxicity studies for methylene chloride have been conducted in
fish, aquatic invertebrates, and aquatic plants. Based on available
data, in the methylene chloride risk assessment EPA concluded that
methylene chloride has low aquatic toxicity for fish, aquatic
invertebrates, and aquatic plants (Ref. 2).
    While methylene chloride is moderately persistent, given its low
bioaccumulation and low hazard for aquatic toxicity, the magnitude of
potential environmental impacts on ecological receptors is judged to be
low for the environmental releases associated with methylene chloride
in paint removal. This should not be misinterpreted to mean that
methylene chloride does not pose environmental

concerns. Through other regulations, EPA is addressing methylene
chloride releases to air and contamination of groundwater, drinking
water, and contaminated soils. While the primary concern with this
contamination has been human health, there is potential for methylene
chloride exposures to ecological receptors in some cases (Ref. 2). More
information about regulations to reduce environmental impacts of
methylene chloride is in Unit III.
    2. What is the global warming potential of methylene chloride?
Global warming potential (GWP) measures the potency of a greenhouse gas
over a specific period of time, relative to carbon dioxide, which has a
high GWP of 1 regardless of the time period used. Due to its
volatility, methylene chloride enters the atmosphere where it reacts
slowly enough to undergo atmospheric transport and act as a greenhouse
gas. Methylene chloride has been reported to the Intergovernmental
Panel on Climate Change as a global warming potential chemical with a
value of 8.7 GWP, or approximately 8.7 times more heat absorptive than
carbon dioxide (Ref. 2).
    3. What is the ozone depletion potential of methylene chloride?
Methylene chloride is not an ozone-depleting substance and is listed as
acceptable under the Significant New Alternatives Policy program for
metal and electronic cleaning (degreasing), aerosol solvents, foam
blowing agents, and other uses (59 FR 13044, March 18, 1994).
    4. Is methylene chloride a volatile organic compound (VOC)? Though
volatile, methylene chloride is exempt from being classified as a VOC
as defined at 40 CFR 51.100(c). A VOC is any compound of carbon,
excluding carbon monoxide, carbon dioxide, carbonic acid, metallic
carbides or carbonates, and ammonium carbonate, which participates in
atmospheric photochemical reactions. Because methylene chloride has
negligible atmospheric photochemical reactions, it is not classified as
a VOC (40 CFR 51.100(s)(1)).
    5. Does methylene chloride persist in the environment and
bioaccumulate? Due to its volatility, methylene chloride does not
significantly partition to solid phases. Therefore, releases of
methylene chloride to the environment are likely to evaporate to the
atmosphere, or if released to soil, migrate to groundwater. Methylene
chloride has been shown to biodegrade over a range of rates and
environmental conditions. Measured bioconcentration factors for
methylene chloride suggest its bioconcentration potential is low (Ref.
2).

III. Regulatory Actions Pertaining to Methylene Chloride

    This section summarizes current state, federal, and international
regulations and restrictions on methylene chloride, with a focus on its
use in paint and coating removal. None of these actions imposes
requirements to the extent necessary so that methylene chloride does
not present the unreasonable risk described in this proposed rule.

A. Federal Actions Pertaining to Methylene Chloride

    Methylene chloride has been the subject of U.S. federal regulations
by EPA, the Consumer Product Safety Commission (CPSC), the Food and
Drug Administration (FDA), and the Occupational Safety and Health
Administration (OSHA). EPA and other agencies have taken actions (see
below) to address the serious human health risks from specific sources
and routes of methylene chloride exposure, but none of these actions
sufficiently mitigate the risks that EPA is proposing to address under
TSCA section 6(a).
    EPA has issued several final rules and notices pertaining to
methylene chloride under EPA's various authorities.
     Clean Air Act: Methylene chloride is designated as a
hazardous air pollutant (HAP) under the Clean Air Act (42 U.S.C.
7412(b)(1))CAA). EPA issued a final rule in January 2008 that
promulgated National Emission Standards for Hazardous Air Pollutants
(NESHAP) for area sources engaged in paint stripping, surface coating
of motor vehicles and mobile equipment, and miscellaneous surface
coating operations. In this NESHAP, EPA listed ``Paint Stripping,''
``Plastic Parts and Products (Surface Coating),'' and ``Autobody
Refinishing Paint Shops'' as area sources of HAPs that contribute to
the risk to public health in urban areas. The final rule included
emissions standards that reflect the generally available control
technology or management practices in each of these area source
categories, and applies to paint stripping operations using methylene
chloride (73 FR 1738, January 9, 2008). In 2014, EPA issued a final
rule for Flexible Polyurethane Foam Manufacturing that banned the use
of methylene chloride as a foam-blowing agent (79 FR 48073, August 15,
2014). In 2015, EPA issued a final rule for Aerospace Manufacturing and
Rework Facilities, which updated a NESHAP from 1995 by adding
limitations to reduce organic and inorganic emissions HAPs, including
methylene chloride, from specialty coating application operations; and
removed exemptions for periods of startup, shutdown and malfunction so
that affected units would be subject to the emission standards at all
times (80 FR 76152, December 7, 2015).
     Solid Waste Disposal Act: Methylene chloride is listed as
a hazardous waste under the Resource Conservation and Recovery Act
(RCRA) (Code U080) (Ref. 2).
     Emergency Planning and Community Right-to-Know Act:
Methylene chloride is listed on the Toxics Release Inventory (TRI)
pursuant to section 313 of the Emergency Planning and Community Right-
to-Know Act (Ref. 2).
     Safe Drinking Water Act: The Safe Drinking Water Act
(SDWA) requires EPA to determine the level of contaminants in drinking
water at which no adverse health effects are likely to occur. EPA has
set a maximum contaminant level goal of zero and an enforceable maximum
contaminant level for methylene chloride at 0.005 mg/L or 5 parts per
billion (57 FR 31776, July 17, 1992).
    Regulation of methylene chloride by other agencies includes:
     In 1987, CPSC issued a statement of policy explaining that
CPSC considers household products containing methylene chloride to be
hazardous substances and providing guidance on labeling of such
products. Labels of products containing methylene chloride are required
to state that inhalation of methylene chloride vapor has caused cancer
in certain laboratory animals, and the labels must specify precautions
to be taken during use by consumers (52 FR 34698, September 14, 1987).
In 2016, CPSC was petitioned by the Halogenated Solvents Industry
Alliance to amend the statement of interpretation and enforcement
policy regarding labeling of household products containing methylene
chloride; CPSC published that petition for public comments (81 FR
60298, September 1, 2016).
     In 1989, FDA banned methylene chloride as an ingredient in
all cosmetic products because of its animal carcinogenicity and likely
hazard to human health (21 CFR 700.19). Before 1989, methylene chloride
had been used in aerosol cosmetic products, such as hairspray (54 FR
27328 (June 29, 1989)).
     OSHA has taken steps to reduce exposure to methylene
chloride in occupational settings. In 1997, OSHA lowered the
permissible exposure limit (PEL) for methylene chloride from an eight-
hour time-weighted average (TWA) of 500 parts per million (ppm) to an
eight-hour TWA of 25 ppm and a 15-minute short-term exposure limit

(STEL) of 125 ppm. This standard also includes provisions for initial
exposure monitoring, engineering controls, work practice controls,
medical monitoring, employee training, personal protective equipment,
and recordkeeping (29 CFR 1910.1052).
     The Department of Housing and Urban Development (HUD) has
prohibited methylene chloride and other hazardous chemicals for use in
removing lead-based paint by HUD contractors and anyone receiving
grants or engaging in the HOME Program, which was created by the
National Affordable Housing Act of 1990 (Ref. 9).
     The National Institute for Occupational Safety and Health
(NIOSH) considers methylene chloride a potential occupational
carcinogen and currently recommends an exposure limit of the ``lowest
feasible concentration'' of methylene chloride (Ref. 10). NIOSH and
OSHA in 2013 issued a hazard alert for bathtub refinishing with
methylene chloride, warning that methylene-chloride based products are
extremely dangerous and that the best way to prevent exposure is to use
products that do not contain methylene chloride (Ref. 11).

B. State Actions Pertaining to Methylene Chloride

    Several states have taken actions to reduce or make the public
aware of risks from methylene chloride. For example, since 2011
methylene chloride has been prohibited from use in graffiti removal in
the District of Columbia and 11 states (California, Connecticut,
Delaware, Illinois, Indiana, Maine, Maryland, Michigan, New Jersey, New
York, and Rhode Island) (Ref.12). Iowa, Indiana, South Carolina, and
other states have established detection monitoring regulations for
methylene chloride (567 IAC 113.15, 329 IAC 10-21-15, S.C. Code Regs.
16-107.198, Appx. III). In Alaska, methylene chloride is listed as a
carcinogenic hazardous substance (18 AAC 75.341). Methylene chloride is
listed on California's Safer Consumer Products regulations candidate
list of chemicals that exhibit a hazard trait and are on an
authoritative list of either chemical hazard traits or potential
exposure concerns (Ref. 13). Methylene chloride is also listed on
California's Proposition 65 list of chemicals known to cause cancer,
birth defects, or reproductive harm (Ref. 13). In Minnesota, it has
been found that methylene chloride may negatively affect the nervous
system and cause cancer (Minn. R. 4717.8200, Minn. R. 4717.8100). The
state of Washington has listed methylene chloride as a human carcinogen
and a chemical of high concern to children (WAC 296-62-07473, WAC 173-
334-130). In Pennsylvania, it is listed as an environmental and special
hazardous substance (34 Pa. Code XIII, Ch. 323.2(a)).
    All states have set PELs identical to the OSHA 25 ppm eight-hour
time weighted average (TWA) PEL (79 FR 61384, October 10, 2014),
however it is worth noting that California, Oregon, and Washington,
which have a state PEL identical to the OSHA PEL, have slightly
different requirements than OSHA for medical evaluation, fit testing
for respirators, and implementation timelines related to methylene
chloride (8 CCR 5502, OAR<PHONE_NUMBER>, WAC 296-62-07470). The OSHA PEL
is considerably higher than the levels at which EPA identified risks of
concern for methylene chloride in paint and coating removal and would
not be protective for the unreasonable risks identified.

C. International Actions Pertaining to Methylene Chloride

    Methylene chloride is also regulated internationally and industrial
and commercial sectors in certain other countries have moved to
alternatives.
    In Canada, the Canadian Minister of the Environment published in
2003 a Notice under Part 4 of the ``Canadian Environmental Protection
Act, 1999'' requiring the preparation and implementation of pollution
prevention plans for methylene chloride (Ref. 14). This Notice targets
persons involved in the use of methylene chloride for the following
activities: Aircraft paint stripping; flexible polyurethane foam
blowing; pharmaceuticals and chemical intermediates manufacturing and
tablet coating; industrial cleaning; and adhesive formulations. Also in
2003, Environment Canada published a Code of Practice for the reduction
of methylene chloride emissions from the use of paint and coating
removal products in commercial furniture refinishing and other
stripping applications (Ref. 14). This Code of Practice was developed
by a multi-stakeholder technical working committee, which consisted of
industry representatives (i.e., furniture refinishers, auto body shops,
formulators of paint and coating removal products, solvent recovery
firms), government personnel, and environmental non-governmental
organizations.
    In the European Union, the European Commission amended its
Registration, Evaluation, Authorization, and Restriction of Chemical
substances in 2010 to incorporate restrictions for the use of methylene
chloride in paint removers. Methylene chloride is banned in the
European Union from: (1) Placement on the market in a new product for
consumers/professionals after December 2010; (2) placement on the
market in any product for consumers/professionals after December 2011;
and (3) use by professionals after June 2012. Member States could allow
the use of methylene chloride if they have a program to license and
train professionals in the following: Awareness; evaluation and
management of risks; use of adequate ventilation; and use of
appropriate personal protective equipment (Ref. 15). The United Kingdom
has issued a derogation to allow professional use of methylene chloride
(Ref. 16). In addition, industrial installations using methylene
chloride must have effective ventilation, minimize evaporation from
tanks, and have measures for safe handling of methylene chloride in
tanks, adequate personal protective equipment, and adequate information
and training for operators. Paint and coating removers containing
methylene chloride in a concentration equal to or greater than 0.1% by
weight must include a label: ``Restricted to industrial use and to
professionals approved in certain EU Member States--verify where use is
allowed'' (Ref. 15).

IV. Methylene Chloride Risk Assessment and Outreach

    In 2013, EPA identified methylene chloride in paint and coating
removal as a priority for risk assessment under the TSCA Work Plan.
This unit describes the development of the methylene chloride risk
assessment and supporting analysis and expert input on the uses that
are the subject of this proposed rule. A more detailed discussion of
the risks associated with methylene chloride in paint and coating
removal can be found in Unit VI.C.1.

A. TSCA Work Plan for Chemical Assessments

    In 2012, EPA released the ``TSCA Work Plan Chemicals: Methods
Document'' in which EPA described the process the Agency intended to
use to identify potential candidate chemicals for near-term review and
assessment under TSCA (Ref. 17). EPA also 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 for further assessment
under TSCA 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. 17).
Using the TSCA Work Plan chemical prioritization criteria, methylene
chloride ranked high for health hazards and exposure potential and was
included on the initial list of TSCA Work Plan chemicals for
assessment. Methylene chloride appeared in the 2012 TSCA Work Plan for
Chemical Assessments and in the 2014 update of the TSCA Work Plan for
Chemical Assessments.

B. Methylene Chloride Risk Assessment

    EPA finalized a TSCA Work Plan Chemical Risk Assessment for
methylene chloride (methylene chloride risk assessment) in August 2014,
following the 2013 peer review of the 2012 draft methylene chloride
risk assessment. All documents from the 2013 peer review of the draft
methylene chloride risk assessment are available in EPA Docket Number
EPA-HQ-OPPT-2012-0725. The completed risk assessment is included in
that docket.
    The methylene chloride risk assessment evaluated health risks to
consumers, workers, and bystanders from inhalation exposures to
methylene chloride when used in paint and coating removal (Ref. 2). EPA
assumes workers and consumers would be adults of both sexes 16 and
older, including pregnant women. EPA assumes bystanders in commercial
or occupational settings would be worker non-users or adjacent workers,
while bystanders in residential settings would be individuals of any
age group (e.g., children, adults, the elderly) nearby during product
application. During scoping and problem formulation for the risk
assessment, EPA focused on paint and coating removal because it was
expected to involve frequent or routine use of methylene chloride in
high concentrations and/or have high potential for human exposure (Ref.
2). However, this does not mean that EPA found that other uses not
included in the methylene chloride risk assessment present low risk.
    The methylene chloride risk assessment characterized human health
effects associated with paint removal with methylene chloride. Based on
the physical-chemical properties of methylene chloride and the paint
and coating removal use scenarios described in the assessment, EPA
assessed inhalation as the predominant route of exposure to methylene
chloride during paint removal. Though highly volatile compounds such as
methylene chloride may also be absorbed through the skin, EPA does not
have the data nor the methodology to assess methylene chloride dermal
exposure during paint removal. As a result, the assessment may
underestimate total exposures to methylene chloride during paint
removal due to this inability to evaluate dermal exposure (Ref. 2).
    The methylene chloride risk assessment identified risks of concern
following acute (short-term) and chronic exposures for workers and
consumers conducting paint removal with methylene chloride, as well as
for exposed bystanders, including residents of homes in which paint
removal is conducted and worker non-users adjacent to other workers
conducting paint removal. The acute risks identified include death;
neurological impacts such as coma, incapacitation, loss of
consciousness, and dizziness; and liver effects. The chronic risks
identified include brain, liver, lung, and hematopoietic cancers and
liver damage (Ref. 2).
    Margins of exposure (MOEs) were used in this assessment to estimate
non-cancer risks for acute exposures (for consumers and workers) and
chronic exposures (for workers). The MOE is the point of departure (an
approximation of the no-observed adverse effect level (NOAEL)) for a
specific health endpoint divided by the exposure concentration for the
specific scenario of concern. The benchmark MOE accounts for the total
uncertainty in a point of departure, including: (1) The variation in
sensitivity among the members of the human population (i.e., interhuman
or intraspecies variability); (2) the uncertainty in extrapolating
animal data to humans (i.e., interspecies variability); (3) the
uncertainty in extrapolating from data obtained in a study with less-
than-lifetime exposure to lifetime exposure (i.e., extrapolating from
subchronic to chronic exposure); and (4) the uncertainty in
extrapolating from a lowest observed adverse effect level rather than
from a NOAEL (Ref. 18). MOEs provide a non-cancer risk profile by
presenting a range of estimates for different non-cancer health effects
for different exposure scenarios, and are a widely recognized method
for evaluating a range of potential non-cancer health risks from
exposure to a chemical. For non-cancer effects EPA estimated exposures
that are significantly larger than the point of departure, thus
resulting in MOEs that are significantly less than the benchmark MOE
(Ref. 2). For methylene chloride, EPA identified acute or chronic non-
cancer risks of concern if the MOE estimates were less than the
benchmark MOE of 10 (Ref. 2). The health endpoint used for the
benchmark MOE for acute exposure to methylene chloride is central
nervous system effects, such as dizziness or incapacitation; the health
endpoint used for the benchmark MOE for chronic exposure to methylene
chloride is liver toxicity. These are the most sensitive adverse health
effects from exposure to methylene chloride.
    Methylene chloride is a likely human carcinogen; cancer risks
determine the estimated incremental increased probability of an
individual in an exposed population developing cancer over a lifetime
following exposure to the chemical under specified use scenarios.
Standard cancer benchmarks used by EPA and other regulatory agencies
are an increased cancer risk of 1 in 1,000,000 ranging to 1 in 10,000
(i.e., 1 x 10-6 to 1 x 10-4). For cancer effects,
EPA estimated that workers and occupational bystanders exposed to
methylene chloride in paint and coating removal have an increase in
cancer risk that ranged from 10 times to almost 1,000 times greater
than a cancer benchmark of 1 in 1,000,000, depending on the specific
way paint or coating removal was conducted with methylene chloride
(Ref. 2).
    The levels of acute and chronic exposures estimated to present low
risk for non-cancer effects also result in low risk for cancer.
    The assessment identified the following risks from acute exposures
to methylene chloride when used in paint and coating removal (Ref. 2):
     Acute risks of incapacitation, coma, or death in workers
exposed to methylene chloride in paint removers when no respiratory
protection is used. In some industries with high exposure scenarios,
these risks of incapacitation or death are present even when
respiratory protection is used.
     Acute risks of neurological effects for most workers.
These risks are present even when respiratory protection is used.
     Acute risks of neurological effects for consumer users of
methylene chloride as a paint remover.
     Acute risks of neurological effects for bystanders
(including children and worker non-users) in the location in which
paint removers containing methylene are used by either residents or
commercial users. 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.
    Based on the risk assessment scenarios, EPA identified the
following non-cancer risks from chronic exposures to methylene chloride
in paint and coating removal (Ref. 2):

     Non-cancer risks for liver effects for most workers
(including worker non-users, or adjacent workers) in industries
conducting paint removal.
     Non-cancer risks occur for most workers (including
adjacent workers) when exposed to paint removers containing methylene
chloride even when wearing respiratory protection in the exposure
scenarios that predominantly demonstrate variations in exposure
conditions (i.e., exposure frequency and working years) in facilities
reporting central tendency or high-end air levels of methylene
chloride. Among all the occupational scenarios, the greatest risk of
concern is for workers engaging in long-term use of or exposure to
methylene chloride as a paint remover (i.e., 250 days/year for 40
years) with no respiratory protection.
    The assessment identified the following cancer risks from chronic
exposures to methylene chloride when used in paint removal (Ref. 2):
     Cancer risks for workers (including adjacent workers)
exposed to methylene chloride as a paint remover in various industries.
These cancer risks include liver cancer, lung cancer, brain cancer,
non-Hodgkin lymphoma, and multiple myeloma.
     The greatest cancer risks occur for workers exposed to
methylene chloride when used as a paint remover who have no respiratory
protection and are exposed for an extended period.

C. Supplemental Analysis Consistent With the Methylene Chloride Risk
Assessment

    Following the methylene chloride risk assessment, EPA conducted
supplemental analyses to inform risk management. These analyses are
consistent with the scope of the methylene chloride risk assessment and
were based on the peer-reviewed methodology used in the methylene
chloride risk assessment. They included identification of baseline and
central tendency exposure scenarios, impacts of reduced methylene
chloride content in paint removers, addition of local exhaust
ventilation (LEV), use of personal protective equipment (PPE),
additional consumer exposure scenarios, and methods of monitoring to
determine workplace exposures. The results of EPA's analyses are
available in this rulemaking docket (Refs. 19, 20, and 21). Prior to
promulgation of the final rule, EPA will peer review the ``Respirator
and Glove Specifications for Workers Exposed to Methylene Chloride in
Paint and Coating Removal,'' ``Supplemental Consumer Exposure and Risk
Estimation Technical Report for Methylene Chloride in Paint and Coating
Removal'', and ``Recommendation for an Existing Chemical Exposure
Concentration Limit (ECEL) for Occupational Use of Methylene Chloride
and Workplace Air Monitoring Methods for Methylene Chloride'' (Refs.
19, 20, 21).

D. Outreach

    In addition to the consultations described in Unit XXIII.C., EPA
engaged in discussions with experts on and users of paint removers
(Ref. 22). The purpose of these discussions was to hear from users,
academics, manufacturers, and members of the public health community
about practices related to paint removal in various industries and by
consumers; the importance of methylene chloride and NMP in paint
removal; frequently-used substitute chemicals or alternative paint
removal methods; engineering control measures and personal protective
equipment currently in use or feasibly adoptable for paint removal; and
other risk reduction approaches that may have already been adopted or
considered for commercial or consumer paint removal. Informed by these
discussions and by industry and other governmental research, EPA has
concluded that alternatives to methylene chloride and NMP are available
for nearly all paint removal uses.
    EPA is continuing to gather information, to the extent practicable,
regarding the availability of alternatives to methylene chloride for
furniture refinishing. EPA plans to continue to engage stakeholders to
identify what methods may be available as alternatives to methylene
chloride. After collecting the information, EPA expects to address this
use of methylene chloride so that the substance no longer poses an
unreasonable risk and intends to issue separately a proposal in the
future. Also see Unit XI.

V. Regulatory Approach for Methylene Chloride in Paint and Coating
Removal

A. TSCA Section 6(a) Unreasonable Risk Analysis

    Under TSCA section 6(a), if the Administrator 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 to the Agency's risk
evaluation, 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.
    TSCA section 6(a) requirements can include one or more, or a
combination of, the following actions:
     Prohibit or otherwise restrict the manufacturing,
processing, or distribution in commerce of such substances (Sec.
6(a)(1)).
     Prohibit or otherwise restrict the manufacturing,
processing, or distribution in commerce of such substances for
particular uses or for uses in excess of a specified concentration
(Sec.  6(a)(2)).
     Require minimum warning labels and instructions (Sec.
6(a)(3)).
     Require recordkeeping or testing (Sec.  6(a)(4)).
     Prohibit or regulate any manner or method of commercial
use (Sec.  6(a)(5)).
     Prohibit or otherwise regulate any manner or method of
disposal (Sec.  6(a)(6)).
     Direct manufacturers and processors to give notice of the
determination to distributors and the public and replace or repurchase
substances (Sec.  6(a)(7)).
    EPA analyzed a wide range of regulatory options under section 6(a)
for each use in order to select the proposed regulatory approach (Refs.
23 and 24). For each use, EPA considered whether a regulatory option
(or combination of options) would address the identified unreasonable
risks so that the chemical substance no longer presents such risks. EPA
found that an option that could reduce exposures such that they would
achieve the benchmark MOE for the most sensitive non-cancer endpoint
would address the risk of concern for other non-cancer endpoints.
Additionally, EPA's assessments for methylene chloride in paint and
coating removal found that exposures that meet the benchmark MOE for
the most sensitive non-cancer endpoint would also not result in cancer
risks of concern.
    After the technical analysis, which represents EPA's assessment of
the potential for the regulatory options to achieve risk benchmarks
based on analysis of exposure scenarios, EPA then considered how
reliably the regulatory options would actually reach these benchmarks.
For the purposes of this proposal, EPA found that an option addressed
the risk so that it was no longer unreasonable if the option could
achieve the benchmark MOE or cancer benchmark for the most sensitive
endpoint. In considering whether a regulatory option would ensure the
chemical no longer presents the unreasonable risk, the Agency
considered whether the option could be realistically implemented or
whether there were practical limitations on how well the option would
mitigate the risks

in relation to the benchmarks, as well as whether the option's
protectiveness was influenced by concerns related to environmental
justice, children's health, and potentially exposed or susceptible
subpopulations identified as relevant to the Agency's risk evaluation.
B. TSCA Section 6(c)(2) Considerations
    TSCA section 6(c)(2) requires EPA to consider and publish a
statement based on reasonably available information with respect to
the:
     Health effects of the chemical substance or mixture (in
this case, methylene chloride) and the magnitude of human exposure to
methylene chloride;
     Environmental effects of methylene chloride and the
magnitude of exposure of the environment to methylene chloride;
     Benefits of methylene chloride for various uses;
     Reasonably ascertainable economic consequences of the
rule, including: The likely effect of the rule on the national economy,
small business, technological innovation, the environment, and public
health; the costs and benefits of the proposed and final rule and of
the one or more primary alternatives that EPA considered; and the cost-
effectiveness of the proposed rule and of the one or more primary
alternatives that EPA considered.
    In addition, in selecting among prohibitions and other restrictions
available under TSCA section 6(a), EPA must factor in, to the extent
practicable, these considerations. Further, in deciding whether to
prohibit or restrict in a manner that substantially prevents a specific
condition of use of a chemical substance or mixture, and in setting an
appropriate transition period for such action, EPA must also consider,
to the extent practicable, whether technically and economically
feasible alternatives that benefit health or the environment will be
reasonably available as a substitute when the proposed prohibition or
other restriction takes effect.
    EPA's analysis of the health effects and magnitude of exposure to
methylene chloride can be found in Units IV.B., VI.C.1. and VI.D.,
which discuss the methylene chloride risk assessment and EPA's
regulatory assessment of methylene chloride in paint and coating
removal. A discussion of the environmental effects of methylene
chloride is in Unit II.D.
    With respect to the costs and benefits of this proposal and the
alternatives EPA considered, as well as the impacts on small
businesses, the full analysis is presented in the Economic Analysis
(Ref. 4). To the extent information was reasonably available, EPA
considered the benefits realized from risk reductions (including
monetized benefits, non-monetized quantified benefits, and qualitative
benefits), offsets to benefits from countervailing risks (e.g., risks
from chemical substitutions and alternative practices), the relative
risk for environmental justice populations and children and other
potentially exposed or susceptible subpopulations (as compared to the
general population), the cost of regulatory requirements for the
various options, and the cost effectiveness of the proposed action and
the one or more primary alternate regulatory options. A discussion of
the benefits EPA considered can be found in Units VI.D. and VII.B. as
well as in the Economic Analysis (Ref. 4).
    EPA considered the estimated costs to regulated entities as well as
the cost to administer and enforce the options. For example, an option
that includes use of a respirator would include inspections to evaluate
compliance with all elements of a respiratory protection program (Ref.
25). In understanding the burden, EPA took into account reasonably
available information about the functionality and performance efficacy
of the regulatory options and the ability to implement the use of
chemical substitutes or other alternatives. Reasonably available
information included the existence of other Federal, state, or
international regulatory requirements associated with each of the
regulatory options as well as the commercial history for the options. A
discussion of the costs EPA considered and a discussion of the cost-
effectiveness of the proposal and the primary alternate regulatory
options that EPA considered is in Units VI.F. and VII.A. In addition, a
discussion of the impacts on small businesses is in Unit XXIII. and in
the Initial Regulatory Flexibility Analysis and Report from the Small
Business Advocacy Review Panel (Refs. 26 and 27).
    With respect to the anticipated effects of this proposal 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. In addition, EPA considered the employment impacts of this
proposal, as discussed in section 9.2 of the Economic Analysis (Ref.
4). EPA found that the direction of change in employment is uncertain,
but EPA expects the short term and longer-term employment effects to be
small.
    The benefits of methylene chloride in paint and coating removal are
discussed in Unit VI.B., along with the availability of alternatives.
The dates that the proposed restrictions would take effect are
discussed in Unit X. The availability of alternatives to methylene
chloride in paint and coating removal on those dates is discussed in
Unit VI.E.
    Finally, with respect to this proposal's effect on technological
innovation, EPA expects this action to spur innovation, not hinder it.
An impending prohibition on this use of methylene chloride is likely to
increase demand for alternatives, which EPA expects would result in the
development of new alternatives. See also section 9.3 in the Economic
Analysis (Ref. 4).

C. Regulatory Options Receiving Limited Evaluation

    EPA analyzed a wide range of regulatory options under TSCA section
6(a). There are a range of regulatory options under TSCA; only those
pertaining to these risks were evaluated in detail. An overview of the
regulatory options not evaluated in detail follows.
    First, EPA reasoned that the TSCA section 6(a)(1) regulatory option
to prohibit the manufacture, processing or distribution in commerce of
methylene chloride or limit the amount of methylene chloride which may
be manufactured, processed or distributed in commerce is not germane
because EPA is not proposing to ban or limit the manufacture,
processing or distribution in commerce of methylene chloride for uses
other than paint and coating removal.
    In addition, EPA determined that the TSCA section 6(a)(6)
regulatory option to prohibit or otherwise regulate any manner or
method of disposal of the chemical is not applicable since EPA did not
assess risks associated with methylene chloride disposal.
    Another option EPA evaluated would require warning labels and
instructions on paint and coating removal products containing methylene
chloride, pursuant to TSCA section 6(a)(3) (Ref. 28). However, EPA
reasoned that warning labels and instructions alone could not
significantly mitigate the unreasonable risks presented by methylene
chloride in paint and coating removal. EPA based its reasoning on an
analysis of 48 relevant studies or meta-analyses, which found that
consumers and professionals do not consistently pay attention to labels
for hazardous substances; consumers, particularly those with lower
literacy levels, often do not understand label information; consumers
and professional users often base a decision to follow label
information on previous experience and perceptions of risk; even if
consumers

and professional users have noticed, read, understood, and believed the
information on a hazardous chemical product label, they may not be
motivated to follow the label information, instructions, or warnings;
and consumers and professional users have varying behavioral responses
to warning labels, as shown by mixed results in studies (Ref. 28).
Additionally, workers being exposed may not be in a position to
influence their employer's decisions about the type of paint removal
method, or ensure that their employer provides appropriate PPE and an
adequate respiratory protection program.
    These conclusions are based on the weight-of-evidence analysis that
EPA conducted of the available literature on the efficacy of labeling
and warnings. This analysis indicates that a label's effectiveness at
changing user behavior to comply with instructions and warnings depends
on the attributes of the label and the user, and how those interact
during multiple human information processing stages, including
attention, comprehension, judgement, and action (Ref. 28).
    Numerous studies have found that product labels and warnings are
effective to some degree. However, the extent of the effectiveness has
varied considerably across studies and some of the perceived
effectiveness may not reflect real-world situations. This is because
interactions among labels, users, the environment, and other factors
greatly influence the degree of a label's effectiveness at changing
user behavior (Ref. 28). In addition, while some studies have shown
that certain components of labels and warnings tend to have some
influence, it is less clear how effective labels and warnings are
likely to be over time, as users become habituated to both the labels
and the products.
    Presenting information about methylene chloride on a product label
would not adequately address the unreasonable risk presented by this
use of this chemical because the nature of the information the user
would need to read, understand, and act upon is extremely complex. When
the precaution or information is simple or uncomplicated (e.g., do not
mix this cleaner with bleach or do not mix this cleaner with ammonia),
it is more likely the user will successfully understand and follow the
direction. In contrast, it would be challenging to most users to follow
the complex product label instructions required to explain how to
reduce exposures to the extremely low levels needed to minimize the
risk from methylene chloride. Rather than a simple message, the label
would need to explain a variety of inter-related factors, including but
not limited to the use of local exhaust ventilation, respirators and
assigned protection factor, and effects to bystanders. Currently,
though some paint removers containing methylene chloride are labeled
with information about its fatal effects if used without ``adequate
ventilation'' (Ref. 28) and this information appears on the product
safety data sheet, deaths continue to occur. It is unlikely that label
language changes for this use of methylene chloride will result in
widespread, consistent, and successful adoption of risk reduction
measures by users.
    Any use of labels to promote or regulate safe product use should be
considered in the context of other potential risk reduction techniques.
As highlighted by a 2014 expert report for the Consumer Product Safety
Commission (CPSC), ``safety and warnings literature consistently
identify warnings as a less effective hazard-control measure than
either designing out a hazard or guarding the consumer from a hazard.
Warnings are less effective primarily because they do not prevent
consumer exposure to the hazard. Instead, they rely on persuading
consumers to alter their behavior in some way to avoid the hazard''
(Ref. 29). Specifically regarding methylene chloride, effective
personal protection resulting in risk reduction would require this
altered behavior to include the appropriate use of a supplied-air
respirator. Consumer users are particularly unlikely to acquire and
correctly use such an apparatus in response to reading a warning label
(Ref. 19). Any labeling aiming to reduce risks to consumer or
commercial users of these products would need to sufficiently and
clearly explain the importance of the supplied-air respirator, and
would still leave the user with the problem of obtaining and properly
using the supplied-air respirator, which is a particularly expensive
piece of equipment (Ref. 4). Further, for the effective use of a
respirator, particularly an air-supplied respirator, there would need
to be fit-testing of the respirator and training in its use.
    While EPA reasons that revised labeling will not address the
unreasonable risk presented by methylene chloride in paint and coating
removal, as a result of recommendations from the Small Business
Advocacy Review (SBAR) Panel to solicit information from the public
about the potential efficacy of labeling, following advice from the
small entity representatives who participated in the SBAR process (Ref.
27), EPA requests public comments on enhanced labeling requirements for
consumer paint and coating removal products containing methylene
chloride as a method for reducing exposure to methylene chloride in
these products. More information about the SBAR process, the Panel
recommendations, and advice from small businesses related to this
proposal are in Unit XXIII. and in the Panel Report (Ref. 27).
    While this regulatory option alone would not adequately address the
unreasonable risks, EPA recognizes that the TSCA section 6(a)(3)
warnings and instruction requirement can be an important component of
an approach that addresses unreasonable risks associated with a
specific use prohibition. EPA has included a downstream notification
requirement as part of the proposed rule to ensure that users would be
made aware of the prohibition on the use of methylene chloride in paint
and coating removal.
    An additional regulatory option receiving limited evaluation was a
training and certification program for commercial paint and coating
removers, similar to the certification process required under EPA's
Lead-Based Paint Renovation, Repair, and Painting Rule (73 FR 21692,
April 22, 2008). This option was recommended by the small entity
representatives as part of the SBAR process (Ref. 27). EPA considered
this option as an approach to reducing risks from methylene chloride in
paint and coating removal. However, unlike the process for training and
certification of commercial workers required under the Lead-Based Paint
Renovation, Repair, and Painting Rule, effective risk reduction from
commercial use of methylene chloride for paint and coating removal
would require additional regulation of distributors of these products.
When considering this approach, given the Agency's experience with the
training and certification program under the Lead-Based Paint
Renovation, Repair, and Painting Rule, EPA viewed the costs and
challenges involved in regulating distributors and ensuring that only
trained and certified commercial users are able to access these paint
and coating removal products as a significant limitation for this
approach. EPA seeks public comment on the feasibility of such a program
and its potential to reduce risks of exposure to methylene chloride for
workers and bystanders so that those risks are no longer unreasonable.

VI. Regulatory Assessment of Methylene Chloride in Paint and Coating
Removal

    This unit describes the current use of methylene chloride in paint
and coating removal, the unreasonable risks presented by this use, and
how EPA identified which regulatory options reduce the risks so that
they are no longer unreasonable.

A. Methylene Chloride Uses That Are the Focus of This Regulation

    The methylene chloride uses that are the focus of this action are:
    1. Any consumer use of methylene chloride for paint and coating
removal, and
    2. Any commercial use of methylene chloride for paint and coating
removal except for commercial furniture refinishing, which EPA intends
to address in a separate proposal, as described in Unit XI. While EPA
proposes to determine that the identified risks from methylene chloride
in commercial furniture refinishing are unreasonable, EPA plans to
continue public engagement before proposing regulations for methylene
chloride in this industry. Additional information is in Unit XI. This
is one of the recommendations from SBAR Panel (Ref. 27),
    EPA proposes to exempt specific paint and coating removal with
methylene chloride from critical corrosion-sensitive components of
military aviation and vessels, which the Department of Defense
identified as critical for national security purposes. The details of
this national security use are in Unit VIII.

B. Methylene Chloride in Paint and Coating Removal

    Methylene chloride has been used for decades in paint and coating
removal in products intended for both commercial and consumer 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
coatings sometimes referred to as high-performance or specialty
coatings; surfaces may be the interior or exterior of buildings,
structures, vehicles, aircraft, marine craft, furniture, or other
objects. Paint and coating removal can be conducted in occupational or
consumer settings. These surfaces, or substrates, include a variety of
materials, such as wood, metals, plastics, concrete, and fiberglass. A
variety of industries include paint and coating removal in their
business activities, including professionals involved in renovations,
bathtub refinishing, automotive refinishing, furniture refinishing, art
restoration and conservation, aircraft repair, marine craft repair, and
graffiti removers (Ref. 3).
    Paint and coatings can be removed by chemical, mechanical, or
thermal means. Chemical paint removers can include solvents, such as
methylene chloride or NMP, caustic chemicals, or other categories of
chemicals. Solvents aid in removing paints and coatings by permeating
the top of the coating and dissolving the bond between the coating and
the substrate (Ref. 30). 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, and spray applications (manually or through
automation). Pouring, wiping and rolling are also possible application
techniques and application can be manual or automated (Ref. 3).
    In the construction trades, methylene chloride is used to remove
paint and coatings from walls, trim, architectural features, patios or
decks, ceilings, bathtubs, floors, etc. to prepare them for new
coatings during residential and commercial building renovation.
Methylene chloride is typically applied to the surface using a hand-
held brush. It is then left on to soften the old coating (Ref. 4). Once
curing has occurred, the old coating is scraped or brushed off and the
surface is cleaned. 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). Consumers use methylene chloride in similar ways.
    Commercially, methylene chloride is also used to remove paint and
coatings from civilian aircraft, marine craft, cars, trucks, railcars,
tankers, storage vessels, and other vehicles or their component parts
to prepare for new coatings. Similar to the constructions trades,
applications in the transportation industry tend to be brushed on and
scraped off. More information on specific techniques for commercial
paint removal and by consumers are in the methylene chloride risk
assessment and supplemental materials (Refs. 2, 19, 20, 21, and 31).
    Though many users are switching to substitutes and alternative
methods, methylene chloride use persists because it is readily
available and works quickly on nearly all coatings without damaging
most substrates. In addition, some users may prefer methylene chloride
because it is less flammable than some other solvents. However, it 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.
Additionally, paint and coating removal products formulated with
methylene chloride tend to contain high concentrations of co-solvents
that are flammable, reducing one perceived advantage of methylene
chloride products.
    Chemical products for paint and coating removal are used across
several industries as well as by consumers or hobbyists, and products
intended for one type of use--such as aircraft renovation--have been
used in other situations, such as bathtub refinishing (Refs. 11, 32,
and 33). Products intended for one specific type of paint removal
project can be easily used in a different setting. Additionally,
consumers can easily use products intended for or marketed to
professional users since paint removal products are readily available
at big box and local hardware stores, as well as paint specialty
stores.
    EPA has 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. 34).
Commercial uses of these products include automotive refinishing,
furniture refinishing, art conservation and restoration, pleasure craft
building and repair, aircraft paint removal, graffiti removal, bathtub
refinishing, and renovations in residences or other buildings. Though
the number of workers and consumers exposed to methylene chloride
during paint and coating removal is uncertain, EPA has several
estimates based on industry data and information gathered for
rulemakings promulgated previously under other statutes, such as the
Clean Air Act, intended to address different risks. As described in
more detail in the Economic Analysis, EPA estimates that 32,600 workers
annually are exposed to methylene chloride during paint and coating
removal activities (Ref. 4). Of them, 15,000 are estimated to be
exposed during furniture refinishing; 17,600 are estimated to be
exposed during other commercial paint and coating removal processes
(Ref. 4).
    Consumer use of methylene chloride in paint and coating removal is
similar to commercial use but is carried out by do-it-yourself (DIY)
consumers and occurs in consumer settings, such as homes, workshops,
basements, garages,

and outdoors. Paint and coating removal products containing methylene
chloride are the same as those used in many commercial settings, and
the process consumers use is similar to commercial methods of brushing
or spraying on the paint and coating removal product, allowing time to
pass for the product to penetrate the coating, and then scraping the
loosened coating from the surface. Manufacturers and retailers of paint
and coating removal products containing methylene chloride frequently
sell them to consumers in small containers with marketing language or
labeling that state they are easy to use and work on a variety of
paints, coatings, and surfaces (Ref. 35). Products intended for
consumers containing methylene chloride must meet minimum labeling
requirements prescribed by CPSC that the product contains methylene
chloride and that it may cause cancer (52 FR 34698, September 14,
1987). Information about risks of death as a result of acute exposure
or methods to reduce exposure through personal protective equipment or
ventilation are not required and frequently are not present on products
containing methylene chloride (Refs. 35 and 36). Paint and coating
removers containing methylene chloride are frequently sold at home
improvement retailers or automotive supply 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 estimates that a
large percentage of users of paint and coating removal products
containing methylene chloride are consumers, rather than occupational
users. EPA estimates that approximately 1.3 million consumers annually
use paint removal products containing methylene chloride (Ref. 4).

C. Analysis of Regulatory Options

    In this unit, EPA explains how it evaluated whether the regulatory
options considered would address the risks presented by this use as
necessary so that the risks are no longer unreasonable. First, EPA
characterizes the unreasonable risks associated with the current use of
methylene chloride in paint and coating removal. Then, EPA describes
its initial analysis of which regulatory options have the potential to
achieve standard non-cancer and cancer benchmarks. The levels of acute
and chronic exposures estimated to present no risks of concern for non-
cancer effects also result in no risks of concern for cancer. Lastly,
this section evaluates how well those regulatory options would address
the unreasonable risk in practice.
    1. Risks associated with the current use.
    a. General impacts. The methylene chloride risk assessment and
supplemental analyses identified acute and chronic risks from
inhalation of methylene chloride during paint and coating removal by
consumers and bystanders in residences; and commercial users and
occupational bystanders in workplaces (individuals not using the paint
and coating remover but nearby a user) (Refs. 2 and 19). EPA estimates,
having refined the numbers since the risk assessment, that, annually,
there are approximately 17,600 direct users at 8,600 commercial
operations conducting paint and coating removal with methylene chloride
for the uses proposed for regulation that will potentially benefit from
the risk reduction resulting from this proposed regulation. EPA
estimates that approximately 1.3 million consumers who use paint and
coating removal products containing methylene chloride each year that
will also potentially benefit from risk reduction resulting from this
proposal (Ref. 4).
    b. Impacts on minority and other populations. While all consumers
and workers using paint and coating removal products containing
methylene chloride would benefit from risk reduction, some populations
are currently at disproportionate risk for the health effects
associated with use of methylene chloride in paint and coating removal.
In the construction trades, Hispanic workers (of all races) and
foreign-born workers are over-represented (Ref. 4). In the U.S.
population, 16% of adults are Hispanic, whereas in the construction
trades, 35% of workers are Hispanic (Ref. 4). Due to their
overrepresentation in the construction trades, Hispanic workers are
disproportionately at risk of exposure to methylene chloride when used
in paint and coating removal.
    Similarly, foreign-born workers are overrepresented in the
construction trades. In the U.S. population overall, 17% of workers in
all industries are foreign-born, whereas in the construction trades,
28% of workers are foreign-born (Ref. 4). As a result, they may
primarily speak a language other than English and could be
characterized as having limited English proficiency. Under Executive
Order 13166, EPA and other agencies are charged with examining and
identifying the needs of individuals with limited English proficiency
(65 FR 50121, August 11, 2000). Like Hispanic workers, foreign-born
workers are disproportionately at risk of exposure to methylene
chloride when used in paint and coating removal in the construction
trades.
    EPA's identification of the current disproportionate risks of
methylene chloride exposure faced by Hispanic and foreign-born workers
in the construction trades is part of the analysis conducted as part of
EPA's efforts towards environmental justice. Executive Order 12898 (59
FR 7629, February 16, 1994) establishes federal executive policy on
environmental justice; EPA's compliance with this executive order is
detailed in Unit XXIII.
    c. Impacts on children. In the methylene chloride risk assessment,
EPA examined acute risks for bystanders to consumer use of methylene
chloride in paint and coating removal in residential settings. Although
EPA expects that users of methylene chloride in paint and coating
removal would be adult individuals (16 years old and older), bystanders
could be individuals of any age group (e.g., children, adults, and the
elderly) who are elsewhere in the house during product application and
in the hours following application (Ref. 2). In most scenarios, EPA
found acute risks of concern for central nervous system effects for
other residents of the house, including children, in which paint and
coating removal with methylene chloride was conducted (Ref 2). EPA
found risks of concern not only during the application of the product,
but also for several hours following (Ref. 2).
    Although EPA anticipates that most consumers conducting paint and
coating removal with methylene chloride would likely exclude children
from the room in which the project was being carried out, it is unclear
if they would exclude them from the house overall during and after the
product application. Additionally, if the project involved removing the
coating from a bathtub, households with only one bathroom would present
challenges for bystander exclusion for several hours. As a result,
children present in homes where paint and coating removal is being
conducted, by family members or by professionals, face acute risks of
central nervous system impacts.
    EPA was not able to model scenarios in which paint and coating
removal was conducted in an apartment building, hotel, or other
residence or place in which children may be present other than single-
family homes. However, the findings related to bystander exposure
suggest risks for children and other

residents of apartments or hotel rooms adjacent to units in which paint
and coating removal is being conducted. In these situations, it is even
less likely that children would be excluded from all affected areas in
order to protect them from acute risks. As a result, methylene chloride
is likely to present acute risks to children as bystanders to paint and
coating removal with methylene chloride, even if they are excluded from
the areas in which work is conducted (Ref. 2).
    d. Exposures for this use. Exposures assessed for this use include
acute exposures to methylene chloride in paint and coating removal by
consumers and residential bystanders, and acute and chronic exposures
by commercial workers and occupational bystanders, as described in the
methylene chloride risk assessment (Ref. 2). In some cases where
commercial paint and coating removal is conducted, such as in workshops
or facilities that are within residences (for example, in the case of
some small businesses) (Ref. 27), exposed bystanders may include family
members, such as children. The exposures assessed included some
commercial furniture refinishing, which is not proposed for regulation.
Different exposure scenarios were evaluated for workers, occupational
bystanders, consumers, and residential bystanders (Ref. 2)
    For exposures in commercial settings, EPA assessed acute risks and
chronic risks, including cancer risks. For acute risks, EPA assessed
four occupational scenarios based on eight-hour TWA exposure
concentrations and different variations in exposure conditions, such as
presence or absence of respirators and the protection factor of any
respirator used. For each commercial use evaluated in the assessment,
EPA modeled scenarios using assumed parameters similar to typical use
conditions within those industries, such as whether work was conducted
indoors or outdoors and what quantity of methylene chloride was
estimated to be used. For these acute workplace estimates, the acute
methylene chloride exposure concentration evaluated for risk was the
eight-hour TWA air concentration in milligrams per cubic meter reported
for the various relevant industries. In the risk assessment, EPA
assumed that some workers could be rotating tasks and not necessarily
carrying out paint and coating removal tasks using methylene chloride
on a daily basis. This type of exposure was characterized as acute in
this assessment because the worker's body was estimated to have
sufficient time to remove methylene chloride and its metabolites before
the next encounter with methylene chloride during paint and coating
removal (Ref. 2).
    For chronic exposure scenarios, EPA varied not only the parameters
described above, but also the number of working days exposed to
methylene chloride during paint and coating removal (ranging from 125
to 250 days per year) and exposed working years (varying the number of
years the worker was assumed to be exposed) (Ref. 2). Overall, EPA
evaluated cancer and chronic non-cancer risks for 16 occupational
scenarios.
    Worker inhalation exposure data were taken from peer-reviewed
literature sources, as cited in the risk assessment (Ref. 2). These
data sources often did not indicate whether monitored exposure
concentrations were for occupational users or bystanders. Therefore,
EPA assumed that these exposure concentrations were for a combination
of users and bystanders. EPA evaluated scenarios both with and without
respirator use and a range of respirator assigned protection factors
(APFs), but did not estimate the overall frequency of respirator use
because supporting data on the prevalence of respirator use for these
commercial uses was unavailable. Similarly, EPA made assumptions about
the exposure frequencies and working years because data were not found
to characterize these parameters, and estimated various exposure
frequencies (125 and 250 days per year) and working years (20 and 40
years). Thus, EPA evaluated occupational risks by developing
hypothetical scenarios under the varying exposure conditions described
previously (Ref. 2).
    It is important to note that EPA relied on monitoring data for
these occupational exposure estimates. Many air concentrations reported
and used in the risk assessment exceeded the current OSHA PEL of 25
ppm; in some industries where paint and coating removal was conducted
by immersion in tanks or vats of methylene chloride, air concentrations
were measured at above 7,000 milligrams per cubic meter, or 2,016 ppm.
Even in industries with lower expected exposures, air concentrations
frequently were reported in excess of 250 milligrams per cubic meter,
or 72 ppm, such as during graffiti removal and automotive refinishing
(Ref. 2). The risks associated with these dramatically high air
concentrations are discussed in Unit VI.C.1.e.
    For consumer and residential bystander exposures, EPA assessed
exposure scenarios under which the individual user was presumed to work
on one of several types of paint and coating removal projects (coffee
table, chest of drawers, or bathtub). These scenarios take into account
that consumers do not reliably use personal protective equipment
(respirators) or have access to engineering controls (e.g., exhaust
ventilation), since these methods are costly, technically challenging,
and not easily available to consumers (Ref. 2). EPA used product label
information to establish the time durations (in minutes) that the user
would require to complete each step of the paint or coating removal
process. User breaks during wait periods were assumed; the scenarios
varied the location of where the user rested (in the work space or
elsewhere). In addition, back-to-back projects were modeled because it
is likely that the user would take breaks during the wait periods
specified on product labels. It was further assumed that the paint
scrapings were removed from the house as soon as scraping was
completed. In each scenario, the bystander was assumed to be somewhere
else in the house, and exposed via inhalation to some of the methylene
chloride from the workspace (Ref. 2).
    EPA developed seven consumer exposure scenarios for the assessment.
Similar to the worker exposure assessment, the following factors were
considered in developing the exposure scenarios (Ref. 2):
     The type of application (i.e., brush-on or spray-on),
weight fraction of methylene chloride in the paint and coating removal
product, application rate by the user, surface area of object from
which the paint or coating was being removed, and emission rate of the
chemical, which can affect the amount of methylene chloride that
ultimately is released to the indoor environment;
     The location where the product is applied, which relates
to exposure factors such as the room volume and its air exchange rate
with outdoor air;
     The house volume and air exchange rate, for reasons
similar to those for the product use location; and
     Precautionary behaviors such as opening windows in the
application room, the user leaving the application room during the wait
period, related changes to the air exchange rates, and the proximity of
the user to the source of methylene chloride emissions.
    In the absence of representative air monitoring data for consumer
users and residential bystanders using paint and coating removal
products containing methylene chloride, EPA used the Multi-Chamber
Concentration and Exposure Model to estimate consumer and bystander
inhalation exposure concentrations (Ref. 2).

    EPA's estimates of the exposures during paint and coating removal
with methylene chloride experienced by commercial users and bystanders
and consumer users and bystanders were used to assess the risks of this
use of methylene chloride. The full exposure estimates and risk
findings are described in the methylene chloride risk assessment; risk
findings are also summarized in Unit VI.C.1.e.
    In addition to estimating likely exposures under current use
patterns (baseline exposures), for both commercial and consumer users,
EPA assessed a number of exposure scenarios associated with risk
reduction options in order to identify variations in methylene chloride
exposure during paint and coating removal. All variations in the
scenarios were applied to industry-specific exposure inputs and
evaluated with exposure parameters that were modified to reflect either
a reasonable worst-case scenario (also called the baseline) or a
scenario in which exposures were moderated by several factors (also
called the central tendency scenario). The risk reduction options that
varied between scenarios included engineering controls, use of PPE, and
well as combinations of these options (Ref. 19).
     Under the PPE risk reduction option exposure scenarios,
EPA evaluated respirators with APF 10 to 10,000 for acute and chronic
risks, including cancer risks.
     For the engineering controls risk reduction option
exposure scenarios, EPA evaluated exposures using local exhaust
ventilation (LEV) to improve ventilation near the activity of workers
(using furniture refinishing operations as a model), with an assumed
90% reduction in exposure levels.
    Overall, EPA evaluated dozens of distinct exposure scenarios for
commercial paint and coating removal with methylene chloride; exposure
reductions for consumer users are expected to be similar to the acute
risk evaluations for professional contractors or workers in furniture
refinishing operations, since these commercial activities are most
similar to the types of projects in which consumers would engage (Refs.
19 and 20).
    e. Specific risks for this use. The acute inhalation risk
assessment used central nervous system effects to evaluate the acute
risks for occupational, consumer, and bystander exposure during paint
and coating removal with methylene chloride. In the risk assessment, a
risk of concern was identified if the MOE estimate was less than the
benchmark MOE of 10 for acute central nervous system effects (Ref. 2).
    EPA assessed acute risks for central nervous system effects from
inhalation for all consumer, occupational, and bystander exposure
scenarios of paint and coating removal with methylene chloride. For
consumers, EPA identified risks of concern for all scenarios, with some
consumer scenarios demonstrating risks within the first hour of product
use when paint and coating removal was conducted indoors (such as in a
workshop or bathroom), regardless of whether the product formulation
was brush or spray. Risks for incapacitating nervous system effects
were found in some indoor scenarios (such as in a bathroom) within four
hours of product use. MOEs for consumer acute risks from exposures of
one hour or less ranged from 1.6 to 0.2; this equates to estimated
exposures that are between six and 50 times greater than those that are
expected to produce no risks of concern (Ref. 2).
    For residential bystanders, EPA identified risks of concern for all
scenarios, even assuming that any bystander in the house was not in the
room where the paint and coating removal occurred. Depending on the
parameters of the scenario, MOEs for acute risks ranged from 2.9 to
0.5, or between three and 20 times greater than those that are expected
to produce no risks of concern (Ref. 2).
    For commercial users, the occupational scenarios in which acute
risks for central nervous system effects were identified included
nearly all occupational scenarios, irrespective of the absence or
presence of respirators, and in both the central-tendency and worst-
case assumed air concentrations of methylene chloride. Additionally,
EPA found acute risks for incapacitating central nervous system effects
for workers who had no respiratory protection in most industries, or
with respirators with APFs of 10 or 25 in the industries with highest
likely exposures, such as professional contractors, aircraft
refinishers, and workers using immersion methods for paint and coating
removal in several industries. MOEs for acute risks ranged from an
average of 0.11 (automotive refinishing) to 0.037 (graffiti removal),
with a lowest end of 0.0063 (workplaces engaged in paint and coating
removal using immersion methods). In general, these workplaces are
estimated to present exposure levels between 100 times to greater than
1,000 times more than those that are of concern. Not only workers, but
also occupational bystanders, or workers engaged in tasks other than
paint and coating removal, would be at acute risk for central nervous
system effects (Ref. 2). Therefore, EPA's proposed determination is
that acute methylene chloride exposures during paint and coating
removal present unreasonable risks.
    In the risk assessment, EPA also assessed risks of chronic exposure
to methylene chloride during paint and coating removal by commercial
users and occupational bystanders (Ref. 2). The methylene chloride risk
assessment used liver toxicity as the critical endpoint for chronic
exposure. EPA assessed risks for liver toxicity for occupational and
bystander exposure scenarios of paint and coating removal with
methylene chloride.
    Workers and occupational bystanders in most industries evaluated
were identified as at risk for non-cancer liver toxicity as a result of
chronic exposure to methylene chloride during paint and coating removal
under typical exposure scenarios. When workers were exposed repeatedly
at facilities they were at risk, even for scenarios evaluated with
workers wearing respiratory protection with APF 50 (Ref. 2). The
concern is for workers engaging in long-term use of the product (i.e.,
250 days/year for 40 years) with no respiratory protection.
    For commercial users and bystanders, EPA also assessed cancer risks
as a result of chronic exposure to methylene chloride in paint and
coating removal. Workers and occupational bystanders showed were
estimated to have an excess cancer risk greater than 1 in 1,000,000 for
all of the commercial scenarios evaluated if exposed to paint and
coating removal with methylene chloride for 250 days per year for 40
years with no respiratory protection. Depending on industry, cancer
risks ranged from 6 in 10,000 (graffiti removal) to 2.5 in 1,000
(aircraft refinishing), with a maximum of 4 in 1,000 (workplaces using
immersion methods, such as dip tanks for miscellaneous metal items).
Workers in all industries showed a relative reduction in cancer risks
when estimated to be working for 125 days per year for 20 years with a
respirator with APF 50, with cancer risks in some industries estimated
to be below benchmark levels in these scenarios. Therefore, EPA's
proposed determination is that chronic methylene chloride exposures
during paint and coating removal present unreasonable risks.
    The SBAR Panel convened in support of this action heard from
several SERs who expressed concerns about the underlying methylene
chloride risk assessment (Ref. 27). Many of the 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.
    2. Initial analysis of potential regulatory options. Having
determined that the risks from methylene chloride in paint and coating
removal were unreasonable, EPA evaluated whether regulatory options
under section 6(a) could reduce the risk (non-cancer and cancer) so
that it is no longer unreasonable.
    The results of EPA's assessment of consumer uses, exposures, and
risks indicate that regulatory options for consumer uses such as
reducing the concentration of methylene chloride or advising the use of
respirators could not achieve the target MOE benchmarks for acute
exposures (benchmark MOE is 10). Similarly, the results of EPA's
evaluation indicate that regulatory options for occupational exposures
such as reducing the concentration of methylene chloride in products
used for paint and coating removal and using local exhaust ventilation
to improve ventilation, in the absence of PPE, could not achieve the
target MOE benchmarks (benchmark MOE is 10) for non-cancer endpoints
for acute and chronic exposures and common cancer risk benchmarks for
chronic exposures (Refs. 19 and 20). The results also demonstrate that
all risk reduction options meeting the benchmark MOEs and common cancer
benchmarks for methylene chloride in paint and coating removal require
the use of a respirator, whether used alone or in conjunction with
additional levels of protection or the use of an air exposure limit.
Therefore, EPA found the options of setting a maximum concentration of
methylene chloride in products under TSCA section 6(a)(2) unable to
reduce exposures to the risk benchmarks. Options found not to meet the
risk benchmarks and, for the purposes of this proposal, found unable to
address the unreasonable risk, are documented in EPA's supplemental
technical reports on methylene chloride in paint and coating removal
(Refs. 19 and 20).
    3. Assessment of whether regulatory options address the identified
unreasonable risk so that methylene chloride in paint and coating
removal no longer presents such risk. As discussed earlier, EPA
considered a number of regulatory options under TSCA section 6(a) for
methylene chloride in paint and coating removal for the uses proposed
for regulation. In assessing these options, EPA considered a wide range
of exposure scenarios (Refs. 19, 20, and 38). These include both
baseline and risk reduction scenarios involving varying factors such as
exposure concentration percentiles, LEV use, respirator use, working
lifetimes, etc. As part of this analysis, EPA considered the impacts of
regulatory options on consumer users and commercial users separately.
However, EPA is proposing to address paint and coating removal with
methylene chloride for consumer uses together with many commercial
uses, rather than as separate consumer and commercial uses. As
described earlier, in Unit VI.B., paint and coating removal products
containing methylene chloride frequently are available in the same
distribution channels to consumers and professional users. Products are
marketed for a variety of projects, and cannot be straightforwardly
restricted to a single type of project or user. As highlighted in the
investigation into recent deaths among bathtub refinishers using
methylene chloride, ``ten different products were associated with the
13 deaths [from 2000-2011]. Six of the products were marketed for use
in the aircraft industry, the rest for use on wood, metal, glass, and
masonry. None of the product labels mentioned bathtub refinishing''
(Ref. 33).
    The options that had the potential to address the unreasonable
risks presented by methylene chloride when used for paint and coating
removal by consumers, or within the commercial uses proposed for
regulation, or for both consumer and these commercial uses included:
    a. A supply-chain approach, which would include prohibiting the
manufacturing (including import), processing, and distribution in
commerce of methylene chloride for paint and coating removal under TSCA
section 6(a)(2) for the consumer and commercial uses proposed for
regulation; prohibiting the commercial use of methylene chloride in
paint and coating removal under TSCA section 6(a)(5) for the commercial
uses proposed for regulation; requiring that all paint and coating
removers containing methylene chloride be distributed in volumes no
less than 55-gallon containers under TSCA section 6(a)(2); requiring
downstream notification when distributing methylene chloride under TSCA
section 6(a)(3); and limited recordkeeping under TSCA section 6(a)(4);
    b. Variations on such an approach, such as just prohibiting the
manufacturing, processing, and distribution in commerce of methylene
chloride for paint and coating removal under TSCA section 6(a)(2) for
consumer use and for the commercial uses proposed for regulation or
just prohibiting the commercial use of methylene chloride for paint and
coating removal under TSCA section 6(a)(5) for the commercial uses
proposed for regulation;
    c. Additional variations on such an approach, such as prohibiting
the manufacturing, processing, and distribution in commerce of
methylene chloride for paint and coating removal under TSCA section
6(a)(2) for the consumer and commercial uses proposed for regulation
and requiring downstream notification (e.g., via a Safety Data Sheet
(SDS)) when distributing methylene chloride for other uses under TSCA
section 6(a)(3); and
    d. Requiring a respiratory protection program, including PPE (a
supplied-air respirator with APF 1,000 or 10,000) with an alternative
air exposure limit of 1 part per million (ppm) achieved through
engineering controls or ventilation alone or in combination with a
supplied-air respirator at a lower APF, in commercial facilities where
methylene chloride is used for paint and coating removal under TSCA
section 6(a)(5) for the commercial uses proposed for regulation.
    A discussion of the regulatory options that could potentially reach
the risk benchmarks for consumer use, commercial uses proposed for
regulation, or both is in this unit, along with EPA's evaluation of how
well those regulatory options would address the unreasonable risks in
practice.
    a. Proposed approach. The proposed regulatory approach for
methylene chloride in paint and coating removal for the uses proposed
for regulation would prohibit the manufacturing, processing, and
distribution in commerce of methylene chloride for paint and coating
removal under TSCA section 6(a)(2) for consumer uses and for the
commercial uses proposed for regulation; would prohibit the commercial
use of methylene chloride for paint and coating removal under TSCA
section 6(a)(5) for the uses proposed for regulation; would require any
remaining paint and coating removal products containing methylene
chloride to be distributed in packaged volumes no less than 55-gallon
containers, under TSCA section 6(a)(2); would require manufacturers,
processors, and distributors to provide downstream notification of the
prohibitions under TSCA section 6(a)(3), and would require
recordkeeping relevant to these

prohibitions under TSCA section 6(a)(4).
    As discussed in Unit VI.C.1., the risks for exposure to consumers,
workers, and bystanders for methylene chloride in paint and coating
removal vary. The MOEs for non-cancer endpoints range from 50 to 1,000
times below the benchmark MOEs for central nervous system effects (the
acute health impact) or liver toxicity (the chronic health impact).
Similarly, the increased risk of cancer (including brain, liver, and
lung cancer) in some industries is 100 to nearly 1,000 times greater
than common cancer benchmarks (Ref. 2). Under this proposed option,
exposures to methylene chloride during paint and coating removal would
be completely eliminated. As a result, non-cancer and cancer risks
would be eliminated.
    The proposed approach would reduce the risks to workers, consumers,
and bystanders from methylene chloride in paint and coating removal for
the uses proposed for regulation so that those risks are no longer
unreasonable. Prohibiting the manufacturing, processing and
distribution in commerce of methylene chloride for paint and coating
removal for the uses proposed for regulation would minimize the overall
availability of methylene chloride for paint and coating removal for
these uses. Importantly, this proposed regulation is protective of
consumer users. EPA cannot regulate consumer use under TSCA section
6(a)(5). The prohibition of the commercial use of methylene chloride
for paint and coating removal in the uses proposed for regulation would
reduce commercial demand for methylene chloride paint and coating
removal products, reduce the likelihood that other types of products
formulated with methylene chloride would be used for paint and coating
removal, and significantly reduce the potential for consumer use of
commercial paint and coating removal products containing methylene
chloride. Workers and occupational bystanders would not be exposed to
methylene chloride for paint and coating removal in the uses proposed
for regulation, and the risk to consumers and residential bystanders
would be minimized because commercial paint and coating removal
products containing methylene chloride would not be available in
volumes smaller than 55-gallon containers. This large volume
requirement would ensure that consumers, who typically buy products in
much smaller volumes, would not be able to easily divert products from
the supply chain intended for commercial furniture refinishing or uses
proposed to be critical to national security. EPA seeks comment on the
impact to commercial furniture refinishers of a requirement that paint
and coating removal products containing methylene chloride be sold only
in 55-gallon containers for commercial paint and coating removal. This
request for comment is one of the recommendations of the SBAR Panel,
described earlier in Unit V.C. and in more detail in Unit XXIII.C.
(Ref. 27). Based on the recommendations from the SBAR Panel, EPA is
requesting comment on whether the rule should allow paint and coating
removal products containing methylene chloride to be sold in 30-gallon
containers, rather than limiting the volume to 55-gallon containers.
EPA is also requesting comment on the feasibility of implementing
appropriate industrial hygiene controls associated with 30- or 55-
gallon containers in order to minimize potential disruptive impacts to
those industrial processes where technically feasible substitutes are
currently unavailable. The downstream notification of these
restrictions ensures that processors and distributors are aware of the
manufacturing, processing, distribution in commerce and use
restrictions for methylene chloride in paint and coating removal, and
enhances the likelihood that the risks associated with this use of
methylene chloride are addressed throughout the supply chain.
Downstream notification also streamlines compliance and enhances
enforcement, since compliance is improved when rules are clearly and
simply communicated (Ref. 39). This integrated supply chain proposed
approach mitigates the risk to consumers and commercial workers and
occupational bystanders in the uses proposed for regulation from
methylene chloride in paint and coating removal.
    b. Options that are variations of elements of the proposed
approach. One variation of the proposed approach would be to prohibit
manufacture, processing, and distribution in commerce of methylene
chloride for consumer and commercial paint removal for the uses
proposed for regulation without the prohibition on commercial use of
methylene chloride for paint and coating removal and without the
downstream notification of any prohibitions. Without the accompanying
prohibition on commercial use and downstream notification that is
included in the proposed supply chain approach, this option would leave
open the likelihood that commercial users falling within the scope of
this proposed rule and consumer users could obtain methylene chloride
(which would continue to be available for other uses, such as
degreasing or solvent purposes) and use it for paint and coating
removal.
    Without downstream notification, unsophisticated purchasers in
particular are likely to be unfamiliar with the prohibitions regarding
this use and mistakenly use methylene chloride for paint and coating
removal, thereby exposing themselves and bystanders to unreasonable
risks. Thus, under these variations, EPA anticipates that many users
would not actually realize the risk benchmarks. Therefore, these
variations fail to protect against the unreasonable risks.
    Another regulatory option that EPA considered was to prohibit only
the commercial use of methylene chloride for paint and coating removal
in the uses proposed for regulation. This approach would reduce both
non-cancer and cancer risks for commercial settings, but it would not
reduce risks to consumers so that they are no longer unreasonable. By
prohibiting use in the commercial sector alone, without a prohibition
on the manufacture, processing, and distribution in commerce of paint
and coating removal products containing methylene chloride for consumer
and commercial use in the uses proposed for regulation, this approach
would not address consumer risks as distributors of paint and coating
removal products containing methylene chloride could continue to
distribute to consumers methylene chloride marked as a paint and
coating remover, including products labeled and marketed as
``professional strength'' or ``commercial grade'' products. Since it is
foreseeable that consumers would continue to purchase products labeled
and marketed in this fashion, and consumers would continue to be
exposed far above the health benchmarks, they would not be protected
from the unreasonable risks posed by methylene chloride.
    c. Prohibit the manufacturing, processing, and distribution in
commerce of methylene chloride for consumer paint and coating removal
under TSCA section 6(a)(2) or prohibit the manufacturing, processing,
and distribution in commerce of methylene chloride for consumer paint
and coating removal under TSCA section 6(a)(2) and require downstream
notification when distributing methylene chloride for other uses under
TSCA section 6(a)(3). EPA considered prohibiting the manufacturing,
processing, and distribution in commerce of methylene chloride for
consumer paint and coating removal including an option with a
requirement for downstream

notification of such prohibition. If such a prohibition were effective,
this option would mitigate the risks to consumers from methylene
chloride in paint and coating removal. However, EPA recognizes that
consumers can easily obtain products labeled for commercial use.
Indeed, for many consumers, identifying a product as being for
commercial use may imply greater efficacy. Coupled with the fact that
many products identified as commercial or professional are readily
obtainable in a variety of venues (e.g., the Internet, general
retailers, and specialty stores, such as automotive stores), EPA does
not find that this option would protect consumers. In addition, this
option alone would not address the risks to workers from methylene