[Federal Register Volume 82, Number 12 (Thursday, January 19, 2017)]
[Proposed Rules]
[Pages 7464-7533]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-01222]
[[Page 7463]]
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
[[Page 7464]]
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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 202-564-0140; email
address: [email protected]. 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: 202-564-4830; email
address: [email protected].
For general information contact: The TSCA-Hotline, ABVI-Goodwill,
422 South Clinton Ave., Rochester, NY 14620; telephone number: (202)
554-1404; email address: [email protected].
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
[[Page 7465]]
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
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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
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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
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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
[[Page 7469]]
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
[[Page 7470]]
(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 437-002-1052, 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
[[Page 7471]]
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):
[[Page 7472]]
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
[[Page 7473]]
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
[[Page 7474]]
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.
[[Page 7475]]
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,
[[Page 7476]]
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
[[Page 7477]]
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).
[[Page 7478]]
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
[[Page 7479]]
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
[[Page 7480]]
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
[[Page 7481]]
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
chloride in paint and coating removal.
d. Requiring a respiratory protection program, including PPE, air
monitoring, and either a supplied-air respirator of APF 1,000 or 10,000
or an air exposure limit of 1 part per million (ppm) achieved through
engineering controls or ventilation, 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.
Another regulatory option that EPA considered for the commercial uses
of methylene chloride for paint and coating removal proposed for
regulation was to require risk reduction through an occupational
respiratory protection program, which would include air monitoring,
medical monitoring, and respiratory protection through use of a
supplied-air respirator with an APF of 1,000 or 10,000, depending on
the methods used for paint and coating removal with methylene chloride
and other workplace characteristics, with a performance-based
alternative of meeting an air concentration level of 1 ppm as an
exposure limit for methylene chloride. A full-facepiece (or helmet/
hood) self-contained breathing apparatus (SCBA) when used in the
pressure demand mode or other positive pressure mode has an APF of
10,000. EPA's analysis showed that use of a SCBA with an APF of 10,000
would, in all scenarios evaluated, control the exposure of methylene
chloride to levels that allow for meeting the benchmarks for non-cancer
and cancer risks. Exposures in most workplaces proposed for regulation
could be reduced with an APF of 1,000 to exposure levels that reduce
risks to benchmark levels (Ref. 19). It is important to note that
current OSHA requirements for dermal and eye protection when using
methylene chloride in any way would be maintained under this approach,
in addition to other requirements for work practices, training, and
hazard communication put forth in OSHA's Methylene Chloride Standard
(29 CFR 1910.1052). It is also important to note that any respirator
used would need to be a supplied-air respirator, since methylene
chloride can clog or damage filters or cartridges for air-purifying
respirators, rendering them non-protective (Ref. 19).
Although respirators, specifically SCBAs, could reduce exposures to
levels that are protective of non-cancer and cancer risks, not all
workers may be able to wear respirators. Individuals with impaired lung
function due to asthma, emphysema, or chronic obstructive pulmonary
disease, for example, may be physically unable to wear a respirator.
Determination of adequate fit and annual fit testing is required for
tight fitting full-face piece respirators to provide the required
protection. Individuals with facial hair, like beards or sideburns that
interfere with a proper face-to-respirator seal, cannot wear tight
fitting respirators. In addition, respirators may also present
communication problems, vision problems, worker fatigue, and reduced
work efficiency (63 FR 1152, January 8, 1998). According to OSHA,
``improperly selected respirators may afford no protection at all (for
example, use of a dust mask against airborne vapors), may be so
uncomfortable as to be intolerable to the wearer, or may hinder vision,
communication, hearing, or movement and thus pose a risk to the
wearer's safety or health.'' (63 FR 1189-1190). Nonetheless, OSHA views
respiratory protection as a backup method which is used to protect
employees from toxic materials in those situations where feasible
engineering controls and work practices are not available or are
insufficient to protect employee health (63 FR 1156-1157). The OSHA
respiratory protection standard (29 CFR 1910.134) requires employers to
establish and implement a respiratory protection program to protect
their respirator-wearing employees. This OSHA standard contains several
requirements, e.g., for program administration; worksite-specific
procedures; respirator selection; employee training; fit testing;
medical evaluation; respirator use; respirator cleaning, maintenance,
and repair; and other provisions.
In addition, OSHA adopted a hierarchy of controls established by
the industrial hygiene community and used to protect employees from
hazardous airborne contaminants, such as methylene chloride (29 CFR
1910.1052). According to this hierarchy, substitution of less toxic
substances, engineering controls, administrative controls, and work
practice controls are the preferred method of compliance for protecting
employees from airborne contaminants and are to be implemented first,
before respiratory protection is used. OSHA permits respirators to be
used where engineering controls are not feasible or during an interim
period while such controls are being implemented.
Given equipment costs and the costs of establishing a respiratory
protection program, which involves training, respirator fit testing,
and the establishment of a medical monitoring program, EPA anticipates
that most companies would choose to switch to substitutes instead of
adopting a program for this type of PPE to continue using methylene
chloride for paint and coating removal because this type of PPE program
is not cost-effective. Further, even if cost were not an impediment,
there are many limitations to the successful implementation of
respirators with an APF of 1,000 or 10,000 in a workplace. As
recommended by the SBAR panel, EPA is requesting comment on and
information about workplace experience with respiratory protection
programs and air monitoring for methylene chloride (Ref. 27).
Specifically, EPA seeks comment on whether companies would opt to
substitute an alternate chemical or process instead of implementing a
worker protection program for PPE. EPA also requests comment on the
scientific and technical support used for development of the 1 ppm air
exposure limit (Ref. 21) for methylene chloride and the feasibility of
implementing and enforcing this performance-based approach.
Additionally, EPA is requesting comment on the cost to achieve reduced
exposures in the workplace or to transition to alternative chemicals or
technologies.
EPA also considered requiring a combination of local exhaust
ventilation and supplied-air respirators with APF of 1,000 or 50, with
a performance-based alternative to the respirator of an air exposure
limit of 1 ppm as an eight-hour TWA. When properly executed, this
option would reduce risks to the health benchmarks for workers and
bystanders (Refs. 19, 21, and 38). However, while this option has the
benefit of incorporating engineering controls and the use of
respirators with a lower APF, the limitations to successful
implementation of the use of supplied-air respirators in the workplace
discussed previously are still present. EPA is requesting comment on
[[Page 7482]]
whether this alternate option of allowing industrial use at specified
exposure levels and with appropriate personal protective equipment
should be adopted. Specifically, EPA seeks information on whether this
alternative approach would incentivize industry to eliminate methylene
chloride use in paint and coating removal wherever technically feasible
while minimizing disruptive impacts to those processes where
technically feasible substitutes are currently unavailable.
Furthermore, neither of the variations of relying upon respiratory
protection for commercial paint and coating removal with methylene
chloride addresses consumer risks. EPA does not have the authority to
require that consumers change use practices or wear PPE. Even if this
approach were coupled with a TSCA section 6(a)(2) prohibition on the
manufacture, processing and distribution in commerce of methylene
chloride for consumer use in paint and coating removal, this would not
protect consumers because they would foreseeably continue to buy and
use paint and coating removal products containing methylene chloride
intended for commercial users, e.g., via the Internet or home
improvement or automotive supply retailers. Consumers would continue to
be exposed far above the established health benchmarks when using
methylene chloride for paint and coating removal (Ref. 20).
Therefore, considering the increased complexity of a respiratory
protection program involving supplied-air respirators as well as the
general inability to require that consumers adhere to a respiratory
protection program resulting in little mitigation of risks to
consumers, an option focusing on respiratory protection would not
address the unreasonable risks presented by these uses.
D. Adverse Health Effects and Related Impacts That Would Be Prevented
by the Proposed Option
The proposed option would prevent exposure to methylene chloride
from paint and coating removal and thus would prevent the risks of
adverse effects and associated impacts. As discussed in Unit II.C., the
range of adverse health effects includes effects on the nervous system,
liver, respiratory system, kidneys, and reproductive systems (Ref. 2).
These health effects associated with exposure to methylene chloride are
serious and can have impacts throughout a lifetime. The following is a
discussion of the impacts of significant acute, chronic non-cancer, and
cancer effects associated with methylene chloride exposure during paint
and coating removal, including the severity of the effect, the
manifestation of the effect, and how the effect impacts a person during
their lifetime.
1. Nervous system effects--acute exposures. The methylene chloride
risk assessment and EPA's 2011 IRIS assessment identified nervous
system effects as the critical effect of greatest concern for acute
exposure to methylene chloride. Specifically, these assessments
identified sensory impairment and incapacitation (loss of
consciousness) as the critical effect of acute exposures (Refs. 2 and
5). Exposure to methylene chloride can rapidly cause death as a result
of nervous system depression, but even exposures that may in some cases
result only in dizziness or fainting can be fatal if the individual who
is disoriented or has fainted is alone. Several individuals have died
after becoming incapacitated during paint and coating removal with
methylene chloride; after losing consciousness, their nervous system is
overcome by the continued accumulation of volatile fumes. As described
in a recent report on deaths caused by methylene chloride, ``. . . the
danger posed by methylene chloride is its one-two punch when fumes
accumulate. Because it turns into carbon monoxide in the body, it can
starve the heart of oxygen and prompt an attack. The chemical also acts
as an anesthetic at high doses: Its victims slump over, no longer
breathing, because the respiratory centers of their brains switch
off.'' (Ref. 7).
There are increased risks of death and nervous system effects for
many of the approximately 17,600 workers in 8,600 commercial facilities
or companies that use methylene chloride for paint and coating removal
for the commercial uses proposed to be regulated, as well as for the
estimated 1.3 million consumers and residential bystanders who use or
are exposed to paint and coating removers containing methylene chloride
each year (Ref. 4).
Although the fact that deaths occur as a result of exposure to
methylene chloride is well documented, the exact number of deaths
specifically attributable to methylene exposure is unclear. In 2012,
the Centers for Disease Control and Prevention Morbidity and Mortality
Weekly Report (MMWR) published results of an investigation into deaths
among bathtub refinishers using methylene chloride. The authors of the
investigation and the MMWR editors emphasized that the reported number
of deaths due to methylene chloride is an underestimate and subject to
at least three limitations: A lack of reporting to the OSHA incident
database by self-employed individuals, no equivalent database to track
consumer incidents and fatalities, and the likelihood that deaths due
to methylene chloride exposures are misattributed to heart disease,
since the pathology is similar (Ref. 33).
Based on data from OSHA, CPSC, state records, and publicly reported
information, EPA has identified 49 fatalities since 1976 resulting from
consumer or commercial worker exposure to methylene chloride during
paint and coating removal, including for uses not proposed for
regulation. However, as described earlier, this is likely an
underestimate of the deaths that have occurred. As highlighted in the
MMWR report from 2012 and OSHA alert from 2016, health effects from
methylene chloride exposure are often misattributed to other causes
(Refs. 32 and 33). For example, in several cases, workers were seen in
hospital emergency rooms with symptoms of solvent exposure, were not
properly diagnosed, and were sent back to the same work that ultimately
killed them (Ref. 32).
Thus, EPA is unable to quantify the precise number or frequency of
deaths that occur as a result of exposure to methylene chloride during
paint and coating removal. However, the sporadically-occurring deaths
outside of bathtub refinishing that have been documented as caused by
methylene chloride, and the undocumented deaths that have been
misattributed to heart disease should not be ignored merely because
they cannot be monetized. Death following exposure to methylene
chloride during paint and coating removal are characterized by family
members as suddenly tragic, particularly when the deceased is young. In
1986 in Colorado, a worker died two hours into his first day on the job
using methylene chloride to remove coatings from furniture (Ref. 40).
In 2014 in New York, a 20-year old worker died while helping his father
with a job refinishing a hotel bathtub (Ref. 41).
Fatalities have also occurred among more experienced workers. In
1990 in Georgia, a worker died while repairing a plastic-coated metal
rack; he was found to have fainted and fallen into the tank of
methylene chloride the company used to strip rack coatings (Ref. 7). In
several instances, pairs of workers were killed while working on the
same paint removal project with methylene chloride, such as renovating
a squash court or the floor tile of a bathroom in a federal office
building (Ref. 40).
In other cases, workers died when helping co-workers in distress.
In South Carolina, in 1986, several workers were
[[Page 7483]]
killed or hospitalized in one incident: Two workers went to check on a
colleague in a basement using a paint remover with methylene chloride;
all three died. Five emergency responders arrived at the scene, and
three were hospitalized due to inhalation of fumes (Ref. 7).
These sudden, unexpected deaths are not limited to commercial users
or occupational bystanders exposed to methylene chloride during paint
and coating removal. Consumer fatalities have been recorded, such as
the woman who died in her house in 1990 in Ohio after removing paint
from furniture with methylene chloride, as reported to the American
Association of Poison Control Centers (Ref. 7). Consistent with the
underreporting of commercial deaths, EPA estimates there are unreported
consumer deaths due to exposure to methylene chloride during paint and
coating removal.
These deaths clearly have a significant impact on families,
workplaces, and communities, and yet not all of them can be monetized.
Similarly, the serious health effects and lifetime impacts on workers
who do not die but who are hospitalized with heart failure, coma, or
other effects also cannot be quantified or monetized. However, the
impacts of these effects should not be ignored. One example is a case
in 2012 in California, where one man attempted to save a co-worker who
had collapsed while cleaning a paint-mixing tank. The collapsed worker
died, and the man attempting to rescue him was incapacitated within
several seconds and lost consciousness. Though he survived, he required
resuscitation, hospitalization for four days, and lengthy follow-up
treatments (Ref. 7). The impacts on workers with severe but non-fatal
nervous system impacts include monetary, personal health, and emotional
suffering costs that cannot be quantified or monetized, but again,
should not be ignored. These severe nervous system impacts can include
coma and heart failure (Ref. 2).
Even when less severe, the nervous system effects of acute exposure
to methylene chloride can have considerable adverse consequences on an
individual, particularly if one is exposed as a bystander who is
unaware of why these nervous system effects are occurring. Commercial
and consumer users as well as bystanders in workplaces and residences
are at risk of dizziness and sensory impairment during most uses of
methylene chloride for paint and coating removal. Similarly, chronic
exposure to methylene chloride presents risks to the nervous system of
commercial users, consumer users, and bystanders exposed to methylene
chloride in paint and coating removal.
2. Nervous system effects--chronic exposures. The methylene
chloride risk assessment identified nervous system effects as adverse
effects of chronic exposure to methylene chloride exposure in paint and
coating removal. There are increased health risks for nervous system
effects for many of the approximately 17,600 workers in 8,600
commercial facilities or companies that use methylene chloride for
paint and coating removal for the commercial uses proposed to be
regulated (Ref. 4).
Chronic exposures in occupational settings put users and bystanders
at risk of cognitive impairment (affecting eye-hand coordination,
tracking tasks, auditory vigilance); adverse effects on autonomic,
neuromuscular, and sensorimotor functions (Ref. 2); and long-term
effects on specific cognitive-neurological measures (i.e., attention
and reaction time) (Ref. 5).
3. Liver toxicity. The methylene chloride risk assessment
identified liver toxicity and liver cancer as adverse effects of
chronic exposure to methylene chloride exposure in paint and coating
removal. There are increased health risks for liver toxicity and liver
cancer for many of the approximately 17,600 workers in 8,600 commercial
facilities or companies that use methylene chloride for paint and
coating removal for the commercial uses proposed to be regulated (Ref.
4).
Specific effects to the liver include hepatic vacuolation and non-
alcoholic fatty liver disease (NAFLD) (Ref. 2). Some form of liver
disease impacts at least 30 million people, or 1 in 10 Americans.
Included in this number is at least 20% of those with NAFLD. NAFLD
tends to impact people who are overweight/obese or have diabetes.
However, an estimated 25% do not have any risk factors. The danger of
NAFLD is that it can cause the liver to swell, which may result in
cirrhosis over time and could even lead to liver cancer or failure
(Ref. 42). The most common known causes to this disease burden are
attributable to alcoholism and viral infections, such as hepatitis A,
B, and C. These known environmental risk factors of hepatitis infection
may result in increased susceptibility of individuals exposed to
organic chemicals such as methylene chloride.
Chronic exposure to methylene chloride can also lead to liver
cancers including hepatocellular carcinomas (HCC), hepatocellular
adenomas, and biliary tract cancer (Ref. 2). The monetizable benefits
associated with reducing the risk of liver cancers associated with
methylene chloride exposure are discussed in Unit VII.B. However, the
impacts of these cancers should not be measured only as dollar
valuations. For example, because HCC is frequently diagnosed only after
an individual's health has deteriorated, survival is usually measured
in months. As a result, ``HCC is responsible for a large proportion of
cancer deaths worldwide . . . HCC classically arises and grows in
silent fashion, making its discovery challenging prior to the
development of later stage disease'' (Ref. 43). Recommended treatments
are aggressive interventions such as the removal of the tumors or
sections of the liver; the life expectancy of patients with HCC is a
mean survival rate of 6 to 20 months. Advanced cases can metastasize to
any organ system, and tends to spread to bones and lungs. Bone pain
related to metastasis is frequently the initial presenting symptom of
HCC (Ref. 43).
Additional medical and emotional costs are associated with cancer
and non-cancer liver toxicity following chronic exposure to methylene
chloride in paint and coating removal, although these costs cannot be
quantified. These costs include medical visits and medication costs. In
some cases, the ability to work can be affected, which in turn impacts
the ability to get proper medical care. Liver toxicity can lead to
jaundice, weakness, fatigue, weight loss, nausea, vomiting, abdominal
pain, impaired metabolism, and liver disease.
Depending upon the severity of the jaundice, treatments can range
significantly. Simple treatment may involve avoiding exposure to
methylene chloride and other solvents; however, this may impact an
individual's ability to continue to work. In severe cases, liver
toxicity can lead to liver failure, which can result in the need for a
liver transplant. Even if a donor is available, liver transplantation
is expensive (with an estimated cost of $575,000) and there are
countervailing risks for this type of treatment (Ref. 44). The mental
and emotional toll on an individual and their family as they try to
identify the cause of sickness and possibly experience an inability to
work, as well as the potential monetary cost of medical treatment
required to regain health, are significant.
4. Hematopoietic cancers. EPA's 2011 IRIS assessment for methylene
chloride found that it is a likely human carcinogen. Chronic inhalation
exposure to methylene chloride such as during paint and coating removal
has been shown to result in increased risk for non[hyphen]Hodgkin's
lymphoma (NHL) or multiple myeloma in workers (Ref. 5). There are
increased risks for NHL or
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multiple myeloma for many of the approximately 17,600 workers in 8,600
commercial facilities or companies that use methylene chloride for
paint and coating removal for the commercial uses proposed to be
regulated (Ref. 4).
NHL is a form of cancer that originates in the lymphatic system.
Approximately 19 new cases per 100,000 adults per year are diagnosed,
with approximately 6.2 deaths per 100,000 adults annually (Ref. 45).
NHL is the seventh most common form of cancer (Ref. 46). Other factors
that may increase the risk of NHL are medications that suppress a
person's immune system, infection with certain viruses and bacteria, or
older age (Ref. 47).
Symptoms of NHL are swollen lymph nodes in the neck, armpits or
groin, abdominal pain or swelling, chest pain, coughing or trouble
breathing, fatigue, fever, night sweats, and weight loss. Depending on
the rate at which the NHL advances, treatment may consist of
monitoring, chemotherapy, radiation, stem cell transplant, medications
that enhance the immune system's ability to fight cancer, or
medications that deliver radiation directly to cancer cells (Ref. 47).
Multiple myeloma is a related hematopoietic cancer, formed by
malignant plasma cells. Multiple myeloma is characterized by low blood
counts, bone and calcium problems, infections, kidney problems, light
chain amyloidosis, and various forms of abnormal plasma cell growth.
Often, multiple myeloma has no clinical symptoms until it reaches an
advanced stage (Ref. 48).
Treatments for NHL or multiple myeloma result in substantial costs
for hospital and doctors' visits in order to treat the cancer.
Treatments for NHL or multiple myeloma can also have countervailing
risks and can lead to patients' higher susceptibility for secondary
malignancies (Refs. 47 and 48). The emotional and mental toll from
wondering whether a treatment will be successful, going through the
actual treatment, and inability to do normal activities, or work will
most likely be high (Ref. 49). This emotional and mental toll could
extend to the person's family and friends as they struggle with the
diagnosis and success and failure of a treatment regime.
5. Brain cancer. EPA's 2011 IRIS assessment for methylene chloride
found that it is a likely human carcinogen. Chronic inhalation exposure
to methylene chloride has been shown to result in brain cancer (Ref.
5). There are increased risks for brain cancer for many of the
approximately 17,600 workers in 8,600 commercial facilities or
companies that use methylene chloride for paint and coating removal for
the commercial uses proposed to be regulated (Ref. 4).
Researchers at the National Cancer Institute found that
``associations of astrocytic brain cancer were observed with likely
exposure to carbon tetrachloride, methylene chloride,
tetrachloroethylene, and trichloroethylene, but were strongest for
methylene chloride. . . . Risk of astrocytic brain tumors increased
with probability and average intensity of exposure, and with duration
of employment in jobs considered exposed to methylene chloride . . .
These trends could not be explained by exposures to the other
solvents'' (Ref. 50).
Cancers that originate in the brain, which include astrocytic brain
cancers, are relatively rare. Astrocytic brain cancers are estimated to
have an incidence of approximately 10 cases per 1 million people per
year, depending on how these types of cancers are defined (Ref. 51).
Astrocytic tumors are characterized by varying degrees of growth
potential and infiltration into nearby tissues. They include tumors
that can spread quickly through the brain stem (brain stem gliomas);
affect the pineal gland, which controls the sleeping and waking cycle
(pineal astrocytic tumors); grow slowly and can be relatively easily
cured (pilocytic astrocytoma); grow slowly but often spread into nearby
tissues (diffuse astrocytoma); grow quickly and spread into nearby
tissues (anaplastic astrocytoma); and grow quickly, spread quickly into
nearby tissues, and usually cannot be cured (glioblastoma) (Ref. 51).
For astrocytic brain cancers, like other primary malignant brain
tumors, initial clinical symptoms are frequently headaches and
seizures. Lower-grade tumors may persist undetected for years, whereas
the faster-growing or faster-spreading tumors may rapidly provoke
neurological decline. Other symptoms may include nausea, vomiting,
headache, and confusion as a result of increased intracranial pressure
(Ref. 51).
Treatment for astrocytic brain cancers varies by the type and stage
of the tumor; it can include pharmacological treatment (for many
patients, this includes steroids and anti-convulsants if they are
experiencing seizures), surgery (depending on location of the tumor,
they may be removed or separated from the brain), chemotherapy, hormone
modulation, or combinations of these treatments (Ref. 51). Like most
cancer treatments, these can have countervailing risks. Additionally,
the emotional and mental tolls described in earlier sections are
relevant to these cancer treatments as well (Ref. 49).
6. Lung cancer. EPA's 2011 IRIS assessment for methylene chloride
found that it is a likely human carcinogen. Chronic inhalation exposure
to methylene chloride has been shown to result in bronchoalveolar
carcinomas (BAC) or bronchoalveolar adenomas, which are forms of lung
cancer (Ref. 5). There are increased risks for these lung cancers for
many of the approximately 17,600 workers in 8,600 commercial facilities
or companies that use methylene chloride for paint and coating removal
for the commercial uses proposed to be regulated (Ref. 4).
BAC is a small percent of lung cancers (between 2% to 4%) and has
unique characteristics. It is notable for its weak relationship with
cigarette smoking; about one-third of patients in the United States
with BAC were never smokers. Additionally, because it rarely spreads
outside the lungs, it is often initially diagnosed as pneumonia or
other lung inflammations (Ref. 52). Most patients do not present
clinical symptoms (Ref. 52) and are only diagnosed following
radiography or biopsy. Treatment requires surgery (Ref. 52). This has
clear countervailing risks, and even if successful in removing any
tumors present, the BAC may return.
7. Mammary tumors. Exposure to methylene has been shown to result
in significant increases in the incidence of adenomas, fibroadenomas,
or fibromas in or near the mammary gland (Refs. 2 and 5). These are
largely benign tumors (Ref. 2). Though many benign tumors do not
require invasive procedures, doctors recommend removing fibroadenomas.
Patients need to undergo a biopsy to identify the carcinogenic risk of
the tumor, and have the tumors removed if they continue to grow, change
the shape of the breast, or are carcinogenic (Ref. 53). If removal is
necessary, the procedure may also require the removal of nearby healthy
mammary tissue, resulting in scarring and changed shape and texture of
the breast (Ref. 53). Women with fibroadenomas and adenomas also have
an increased risk of breast cancer, estimated to be approximately 1.5
to 2.0 times the risk of women with no breast changes (Ref. 54).
8. Reproductive effects. EPA's 2011 IRIS assessment for methylene
chloride found that exposure can have reproductive effects that include
testicular and ovarian atrophy (Ref. 5). At very high exposures,
chronic inhalation of methylene chloride during paint and coating
removal can result in these reproductive effects, which are related to
decreased fertility (Ref. 55).
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There are increased risks for these reproductive effects for many of
the approximately 17,600 workers in 8,600 commercial facilities or
companies that use methylene chloride for paint and coating removal for
the commercial uses proposed to be regulated (Ref. 4). Similar to
effects discussed previously, while neither the precise reduction in
individual risk of developing this disorder from reducing exposure to
methylene chloride or the total number of cases avoided can be
estimated, EPA still considers their impact.
9. Kidney toxicity. EPA's 2011 IRIS assessment for methylene
chloride identified kidney effects from exposure to methylene chloride;
these effects include renal tubular degeneration (Ref. 5). At very high
exposures, chronic inhalation exposure to methylene chloride during
paint and coating removal can result in kidney toxicity. There are
increased risks for these kidney effects for many of the approximately
17,600 workers in 8,600 commercial facilities or companies that use
methylene chloride for paint and coating removal for the commercial
uses proposed to be regulated (Ref. 4).
Exposure to methylene chloride can lead to changes in the proximal
tubules of the kidney. This damage may result in signs and symptoms of
acute kidney failure that include; decreased urine output, although
occasionally urine output remains normal; fluid retention, causing
swelling in the legs, ankles or feet; drowsiness; shortness of breath;
fatigue; confusion; nausea; seizures or coma in severe cases; and chest
pain or pressure. Sometimes acute kidney failure causes no signs or
symptoms and is detected through lab tests done for another reason.
Kidney toxicity means the kidney has suffered damage that can
result in a person being unable to rid their body of excess urine and
wastes. In extreme cases where the kidney is impaired over a long
period of time, the kidney could be damaged to the point that it no
longer functions. When a kidney no longer functions, a person needs
dialysis and ideally a kidney transplant. In some cases, a non-
functioning kidney can result in death. Kidney dialysis and kidney
transplantation are expensive and incur long-term health costs if
kidney function fails (Ref. 56).
The monetary cost of kidney toxicity varies depending on the
severity of the damage to the kidney. In less severe cases, doctor
visits may be limited and hospital stays unnecessary. In more severe
cases, a person may need serious medical interventions, such as
dialysis or a kidney transplant if a donor is available, which can
result in high medical expenses due to numerous hospital and doctor
visits for regular dialysis and surgery if a transplant occurs. The
costs for hemodialysis, as charged by hospitals, can be upwards of
$100,000 per month (Ref. 57).
Depending on the severity of the kidney damage, kidney disease can
impact a person's ability to work and live a normal life, which in turn
takes a mental and emotional toll on the patient. In less severe cases,
the impact on a person's quality of life may be limited while in
instances where kidney damage is severe, a person's quality of life and
ability to work would be affected. While neither the precise reduction
in individual risk of developing kidney toxicity from reducing exposure
to methylene chloride during paint or coating removal or the total
number of cases avoided can be estimated, these costs must still be
considered because they can significantly impact those exposed to
methylene chloride.
10. Disproportionate impacts on environmental justice communities.
An additional factor that cannot be monetized is the disproportionate
impact on environmental justice communities. As described in Unit
VI.C.1.b., Hispanic and foreign-born workers, who may have limited
English proficiency, are disproportionately over-represented in
construction trades (Ref. 4), in which methylene chloride is used for
paint and coating removal. Because they are disproportionately over-
represented in this industry, these populations are disproportionately
exposed to methylene chloride during paint and coating removal, and are
disproportionately at risk to the range of adverse health effects
described in this unit.
E. Availability of Alternatives
For almost every situation in which methylene chloride is used to
remove paints or coatings, EPA is aware of technically and economically
feasible chemical substitutes or alternative methods that are
reasonably available. The two situations for which EPA does not know of
technically and economically feasible alternatives are the uses that
EPA proposes are critical for national security, described in more
detail in Unit VIII., and commercial furniture refinishing, discussed
in more depth in Unit XI. With respect to the specific coating removal
uses that EPA proposes are critical for national security, described in
Unit VIII., EPA does not believe that technically and economically
feasible alternatives are reasonably available at this time. With
respect to the furniture refinishing uses described in Unit XI., EPA is
still investigating whether economically feasible alternatives are
reasonably available.
EPA considered chemical substitutes and alternative methods
consistent with the requirements of TSCA section 6(c)(2)(C) and as
similarly recommended by the SBAR panel (Ref. 27). A full industry
profile characterizing manufacturers, processors and end users of
methylene chloride for paint and coating removal and a use and
substitutes analysis are included in sections 2 and 3 of EPA's economic
assessment (Ref. 4). As described below, EPA proposes that alternatives
are technologically feasible, economically feasible, reasonably
available, and present fewer hazards to human health than methylene
chloride in paint and coating removal. EPA requests comment on whether
its conclusion that substitutes for methylene chloride identified are
available and technically and economically feasible is accurate and
whether its consideration of alternatives was sufficient to satisfy the
requirements of TSCA section 6(c)(2)(C).
Research into the efficacy of chemical substitutes has identified
products currently available for commercial and consumer users of
methylene chloride for paint and coating removal, for a variety of
coatings on numerous substrates (Refs. 58 and 59). Research by the
European Association for Safer Coating Removal in 2006 found that for
every use that was studied of methylene chloride in paint and coating
removal, there was a suitable substitute (Ref. 60). Other non-chemical
methods of paint removal are also available (Ref. 31). Additionally, in
most commercial sectors, users have voluntarily adopted substitute
chemicals or methods, either due to financial considerations, customer
requests, concern for worker or individual health and safety, decreased
discharges to air and water, reduced clean-up costs, or reduced cost of
protective equipment and respiratory protection programs (Ref. 22).
Many producers of paint and coating removal products containing
methylene chloride also produce paint and coating removal products with
substitute chemicals (Ref. 4). This was emphasized by a small business
who makes such products (Ref. 22); other small businesses separately
described the limitations of many alternatives (Ref. 27). Thus, there
is already precedent for producers reformulating products to meet
demand from commercial or individual customers. Additionally, methylene
chloride is prohibited from use in graffiti removal in California,
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Connecticut, Delaware, the District of Columbia, Illinois, Indiana,
Maine, Maryland, Massachusetts, Michigan, New York, and Rhode Island
(Ref. 12). The fact that 11 states and the District of Columbia have
specifically prohibited the use of methylene chloride in graffiti
removal supports a finding that it is not critical for this use and
that there are efficacious substitutes.
Based on the frequent use of substitute chemicals or alternative
methods for paint and coating removal in all industries discussed here,
and the formulation and distribution of substitute chemicals for paint
and coating removal by all formulators of products containing methylene
chloride (Ref. 4), EPA finds that technically and economically feasible
alternatives to methylene chloride are reasonably available for all
uses proposed for regulation.
Primary chemical substitutes for methylene chloride in paint and
coating removal include products formulated with benzyl alcohol;
dibasic esters; acetone, toluene, and methanol (collectively ATM); and
caustic chemicals. EPA evaluated these products for efficacy, toxicity,
relative hazards compared to methylene chloride, and other hazards that
might be introduced by use of these products (such as environmental
toxicity, increased global warming potential, and increased
flammability or other hazards to users). Overall, while the efficacies
of the substitutes are comparable to the efficacy of methylene
chloride, none of the substitute chemicals already available has the
level of toxicity associated with methylene chloride.
Products based on benzyl alcohol formulations have been identified
as efficacious paint and coating removers in various industry sectors
(Refs. 22 and 27). Consumer products containing benzyl alcohol are
available for sale (Refs. 22, 27, 35, 58, 59, and 61). There are fewer
hazard concerns compared to methylene chloride-based products, and the
levels at which benzyl alcohol causes toxicity are higher than for
methylene chloride, suggesting lower toxicity (Ref. 34). The relative
inhalation exposure potential is lower for benzyl alcohol than for
methylene chloride. The relative dermal exposure potential of benzyl
alcohol is similar to methylene chloride (Ref. 34). Benzyl alcohol-
based paint removers are expected to result in lower risks than
methylene chloride products, primarily due to lower toxicity (Ref. 29).
Dibasic ester products can include dimethyl succinate, dimethyl
glutarate and dimethyl adipate. They are generally viewed as
efficacious products by commercial users in several sectors, though,
because they evaporate slowly, they require a longer dwell time than
methylene chloride (Ref. 22, 27). In general, the hazards associated
with dibasic esters are less severe and occur at concentrations higher
than methylene chloride (Ref. 34). Regarding differential exposures
between dibasic esters and methylene chloride, the relative inhalation
exposure potential is lower for dibasic esters than for methylene
chloride (Ref. 34). The relative dermal exposure potentials of dibasic
esters are similar to methylene chloride. Taken together, dibasic
ester-based paint removers are expected to result in lower risks than
methylene chloride products, primarily due to lower toxicity (Ref. 34).
ATM products contain acetone, toluene, and methanol. Products
containing these chemicals may remove coatings very quickly, but may
not be effective on every type of coating (Refs. 22 and 27). Acetone,
toluene, and methanol evaporate quickly and are very flammable (Ref.
62). However, it is important to note that acetone, toluene, and/or
methanol are present in most paint removers that contain methylene
chloride, as co-solvents (Ref. 34). As a result, the main difference
between paint removers that contain methylene chloride (and typically
also contain acetone, toluene, and/or methanol) and ATM products is the
absence of methylene chloride. Acetone is readily absorbed via
inhalation and the relative inhalation exposure potential is similar to
methylene chloride (Ref. 34). Acetone in particular is significantly
less toxic than methylene chloride. Toluene and methanol are readily
absorbed via inhalation, but the relative inhalation exposure potential
is lower than for methylene chloride (Ref. 34). Dermal exposure to
acetone, toluene and methanol is slightly less than for methylene
chloride (Ref. 34). Taken together, ATM-based paint removers are
expected to result in lower cancer risks (Ref. 36).
Products with caustic chemicals typically include calcium hydroxide
or magnesium hydroxide. In many uses, they can be effective products,
particularly when multiple coatings are being removed from a substrate.
Caustic products have been reported to remove up to 30 coats in 24
hours, and in some cases, they have no increased dwell time compared to
methylene chloride (Ref. 23). In contrast to methylene chloride-based
products, there are no cancer or other repeat dose endpoints of concern
associated with caustic products (Ref. 34). Caustic products pose acute
concerns due to their physical chemical properties and can cause
chemical burns (Ref. 36). It is important to note that products
containing methylene chloride may also cause chemical burns.
Additionally, the risks associated with caustic-based products are
entirely acute, and can be mitigated by appropriate protective
equipment more easily than the acute and chronic risks presented by
methylene chloride.
In summary, when NMP is excluded from consideration, the most
likely chemical substitutes for methylene chloride in paint and coating
removal do not pose a risk of cancer to users, generally have lower
exposure potential than methylene chloride, and when acute risks are
present, as in the case of caustic chemicals, those risks are self-
limiting by the nature of the adverse effects (since a user
experiencing those effects is likely to take immediate action to
mitigate or cease the effect of the caustic chemical). The chemical
formulations that seem to present some risks of concern are ATM
products, since they contain toluene and methanol. However, these
chemicals are also present in most paint removers that contain
methylene chloride, as co-solvents. As a result, no additional risks
would be introduced were users to substitute a typical methylene
chloride product (which would likely contain acetone, toluene, and/or
methanol as co-solvents) with ATM products.
In addition to examining toxicity to humans, EPA reviewed available
data on the chemicals in the baseline and alternative products for
aquatic toxicity, persistence and bioaccumulation data, as a basis for
examining potential environmental toxicity. Only one chemical evaluated
(citrus terpenes) may have significant impacts on aquatic toxicity,
with concern for environmental persistence and/or bioaccumulation. This
chemical is contained in NMP-based paint removal products (Ref. 34).
EPA is also mindful of the risks that may be introduced by
substitute chemicals or methods to increase global warming, and has
examined the global warming potential of the chemical components of
likely chemical substitutes for methylene chloride in paint and coating
removal. Methylene chloride presents concerns for global warming; it
has a GWP of 8.7 (see Unit II.D.2.). The GWP values of likely
substitute chemicals in paint and coating removal are: 0 GWP (benzyl
alcohol, ATM) or not assessed (caustics, dibasic esters) (Ref. 23). As
such, EPA has not identified any increased risk of global warming that
would be introduced by use of chemical products
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as substitutes for methylene chloride in paint and coating removal.
In addition to human and environmental toxicity, other hazards
associated with chemical methods for paint and coating removal are
risks of fire due to flammability of the chemical product, and
poisoning or acute injury. Risks of fire are serious when using
solvents such as paint and coating removal chemicals. The flammability
of methylene chloride is lower than some of the substitute organic
solvents. However, many paint and coating removal products containing
methylene chloride also contain more flammable chemicals as part of the
formulation (Ref. 34). Paint and coating removal products sold to
consumers that contain methylene chloride frequently have flammability
warnings prominently on them (Ref. 35). Other chemical paint and
coating removal products, such as those based on benzyl alcohol and
dibasic esters, have low flammability and do not present an increased
risk of fire from products containing methylene chloride (Ref. 23).
Even among products that fall within the same general product
composition category, there is meaningful variability in the specific
formulations of paint remover products, and thus in their flammability.
Furthermore, it is impracticable for EPA to predict the specific
product formulations for which use will increase as a result of
prohibitions on methylene chloride in paint and coating removal. It is
therefore impracticable for EPA to forecast whether the flammability of
popular paint and coating removers would generally increase or decrease
as a result of the proposed rule.
In addition to using substitute chemical products, non-chemical
methods for paint and coating removal are frequently used. These
include thermal removal, sanding, hydroblasting, abrasive blasting, and
laser removal (Refs. 22 and 31). Acute and chronic physical hazards
(e.g., burns, injuries to bodily parts) to workers and consumers can
occur, in addition to any lead-related risks that should be considered
when using these methods with lead-based paint.
In this overview, when considering alternatives to methylene
chloride that would be available, NMP generally was not considered
because, under the first co-proposed option for NMP in this proposed
rule, this chemical would also be prohibited from use in paint and
coating removal. However, under the second co-proposed approach for
reducing the risks of NMP in paint and coating removal, products
containing NMP would be available for commercial and consumer paint and
coating removal, with restrictions. Details of the two co-proposed
options are in Unit XVI.3. EPA identified developmental risks following
acute exposures for consumers and acute and chronic exposures for
commercial users of paint and coating removal products containing NMP
following exposure through dermal contact, inhalation, and vapor-
through-skin. More information on the risks EPA identified related to
NMP are in Unit XVI.B.1.
F. Impacts of the Proposed and Alternative Regulatory Options
This unit describes the estimated costs of the proposed and
alternative regulatory actions that EPA considered for methylene
chloride in paint and coating removal. More information on the benefits
and costs of this proposal as a whole can be found in Unit XXIII.
1. Proposed approach for methylene chloride in paint and coating
removal. The costs of the proposed approach are estimated to include
product reformulation costs, downstream notification costs,
recordkeeping costs, and Agency costs. The costs of paint and coating
removal product reformulations are estimated to be approximately
$10,000 to $20,000 per year (annualized at 3% over 20 years) and
$14,000 to $24,000 (annualized at 7% over 20 years). The cost for
reformulation includes a variety of factors such as identifying the
appropriate substitute chemical for methylene chloride in the
formulation, assessing the efficacy of the new formulation and
determining shelf-life. Under the first co-proposed approach for NMP,
where the manufacturing, processing, distribution, and commercial use
of paint and coating removal products containing NMP would be
prohibited, the costs to users of paint and coating removers containing
methylene chloride are $4,217,000 to $23,436,000 using a 3% discount
rate and $4,592,000 to $23,485,000 at the 7% discount rate (both rates
annualized over 20 years). The costs of downstream notification and
recordkeeping on an annualized basis over 20 years are $40 and $60
using 3% and 7% discount rates respectively (Ref. 4). Agency costs for
enforcement are estimated to be approximately $114,401 and $111,718
annualized over 20 years at 3% and 7%, respectively. The total cost of
the proposed approach for paint and coating removers containing
methylene chloride under the first co-proposed approach for NMP is
estimated to be $4,247,000 to $23,446,000 and $4,612,000 to $23,495,000
annualized over 20 years at 3% and 7%, respectively (Ref. 4). Under the
second co-proposed approach for NMP, where paint and coating removal
products containing NMP would be available with some restrictions, the
costs to users of paint and coating removers containing methylene
chloride are $67,087,960 to $68,726,960 using a 3% discount rate and
$67,369,940 to $69,006,940 at the 7% discount rate (both rates
annualized over 20 years). The costs of downstream notification and
recordkeeping on an annualized basis over 20 years are the same as
under the first co-proposed approach for NMP. Agency costs for
enforcement are estimated to be the same as under the first co-proposed
approach for NMP. The total cost of the proposed approach for paint and
coating removers containing methylene chloride under the second co-
proposed approach for NMP is estimated to be $67,098,000 to $68,747,000
and $67,384,000 to $69,034,000 annualized over 20 years at 3% and 7%,
respectively (Refs. 4 and 127).
2. Options that require personal protective equipment for methylene
chloride in paint and coating removal. Given equipment costs and the
requirements associated with establishing a respiratory protection
program which involves training, respirator fit testing and the
establishment and maintenance of a medical monitoring program, EPA
considers the proposed approach more cost-effective than options that
require person protective equipment. This is because EPA anticipates
that companies would choose to switch to substitute chemicals instead
of adopting a program for PPE, including with a performance-based
option of meeting an air concentration level of 1 ppm as an exposure
limit for methylene chloride in paint and coating removal. The
estimated annualized costs of switching to a respiratory protection
program requiring PPE of APF 1,000 are $13,775,000 to $26,535,000 at 3%
and $14,202,000 to $26,708,000 at 7% over 20 years (Ref. 4). In
addition, there would be higher EPA administration and enforcement
costs with a respiratory protection program under the proposed
approach.
3. Options that exclude downstream notification. For those options
that exclude downstream notification, the options are less effective
and more to challenging to implement. The downstream notification
(e.g., via SDS) provides additional information on the prohibitions
under the proposed option for processors and distributors of methylene
chloride or products containing methylene chloride other than paint and
coating removers, and
[[Page 7488]]
provides an efficient way for those entities to recognize themselves as
affected by the regulation, which contributes to a more effective
regulation (Ref. 63). In this way, the downstream notification
component of the supply chain approach contributes to the use no longer
presenting an unreasonable risk because it streamlines and aids in
compliance and implementation (Ref. 64).
G. Summary
The proposed approach is necessary so that methylene chloride in
paint and coating removal no longer presents an unreasonable risk. It
is also more cost effective than other regulatory options the Agency
identified as potentially reducing risks so that they are no longer
unreasonable, because it achieves the benefits of reducing the
unreasonable risks so they are no longer unreasonable for a lower cost
than the primary alternative option. For more information, see section
6 in the Economic Analysis (Ref. 4).
As stated previously in this notice, the proposed approach
includes:
Prohibiting manufacturing (including import), processing,
and distribution in commerce of methylene chloride for consumer paint
and coating removal and commercial paint and coating removal for the
uses proposed for regulation;
Prohibiting commercial use of methylene chloride for paint
and coating removal for the uses proposed for regulation;
Requiring that any products containing methylene chloride
intended or used for paint and coating removal be distributed in
volumes no less than 55-gallon containers;
Requiring downstream notification of the prohibition on
manufacturing (including import) processing, and distribution of
methylene chloride for paint and coating removal for the prohibited
uses; and
Requiring limited recordkeeping.
Technically and economically feasible substitutes to methylene
chloride for paint and coating removal are reasonably available for the
uses proposed to be regulated. The supply chain approach ensures
protection of consumers from the unreasonable risk by precluding the
off-label purchase of commercial products by consumers.
The proposed approach is relatively easy to enforce because key
requirements are directly placed on a small number of suppliers and
because the supply chain approach minimizes to the greatest extent the
potential for methylene chloride products to be intentionally or
unintentionally misdirected into the prohibited uses. Enforcement under
the other options would be much more difficult since the key
requirements are directly placed on the large number of product users.
As described in a recent article on designing more effective rules and
permits, ``the government can implement rules more effectively and
efficiently when the universes of regulated sources are smaller and
better-defined. This is because, other factors being equal, governments
can more easily identify, monitor, and enforce against fewer, rather
than more, entities'' (Ref. 63). Under other options, enforcement
activities must target firms that might perform the activity where a
use of methylene chloride is restricted or prohibited. Identifying
which establishments might use paint and coating removers is difficult
because paint and coating removal is not strictly specific to any
industry (Ref. 4).
VII. Costs and Monetized Benefits of the Methylene Chloride Component
of the Proposed Rule, the Alternatives EPA Considered, and Comparison
of Costs and Benefits
EPA proposes that the identified risks from methylene chloride and
in paint and coating removal are unreasonable risks. Apart from that
proposed determination, EPA has evaluated the potential costs and
benefits of the proposed approach and alternative approaches.
A. Costs
The details of the costs of the proposed approach for use of
methylene chloride in paint and coating removal by consumers and in
commercial uses proposed for regulation are discussed in Unit I.E. and
in the Economic Analysis (Ref. 4). Under the proposed option for
methylene chloride and the first co-proposed option for NMP, costs to
users of paint and coating removal products containing methylene
chloride are $4,217,000 to $23,436,000 annualized for 20 years at a
discount rate of 3% and $4,592,000 to $23,485,000 at a discount rate of
7%. Costs of paint and coating removal product reformulations are
estimated to be approximately $10,000 to $20,000 per year (annualized
at 3% over 20 years) and $14,000 to $24,000 (annualized at 7% over 20
years). Costs of downstream notification and recordkeeping on an
annualized basis over 20 years are $40 and $60 using 3% and 7% discount
rates respectively. Agency costs for enforcement are estimated to be
approximately $114,401 and $111,718 annualized over 20 years at 3% and
7%, respectively (Ref. 4).
Total costs of the proposed rule relevant to methylene chloride in
paint and coating removal under the first co-proposed option for NMP
are estimated to be $4,247,000 to $23,446,000 annualized over 20 years
at 3% and $4,612,000 to $23,495,000 annualized over 20 years at 7%
(Ref. 4).
Under the proposed option for methylene chloride and the second co-
proposed option for NMP, costs to users of paint and coating removal
products containing methylene chloride are $67,087,960 to $68,726,960
annualized for 20 years at a discount rate of 3% and $67,369,940 to
$69,006,940 at a discount rate of 7%. Costs of paint and coating
removal product reformulations, costs of downstream notification, and
Agency costs for enforcement are estimated to be the same as under the
first co-proposed option for NMP (Refs. 4 and 127).
Total costs of the proposed rule relevant to methylene chloride in
paint and coating removal under the second co-proposed option for NMP
are estimated to be $67,098,000 to $68,747,000 annualized over 20 years
at 3% and $67,384,000 to $69,034,000 annualized over 20 years at 7%
(Refs. 4 and 127).
Alternatives that EPA considered include the use of PPE as well as
an option that would prohibit the use of methylene chloride in paint
and coating removal for consumers and for the commercial uses proposed
for regulation without the companion prohibition on manufacture,
processing, or distribution in commerce for these uses or the
downstream notification requirements. As discussed in Unit VI.C.3., EPA
found that PPE options did not address the risks presented by methylene
chloride in paint and coating removal so that the risks would no longer
be unreasonable. This is because consumers could not be required to
adopt PPE, resulting in a significant gap in protection for consumers.
In addition, EPA also assumed that no commercial users would adopt PPE
because the per-facility costs were prohibitively expensive.
EPA also found that a use prohibition alone without downstream
notification requirements would not address the unreasonable risks. EPA
estimated the costs of this option to be $4,239,000 to $23,442,000
annualized over 20 years at 3% and $4,604,000 to $23,491,000 annualized
over 20 years at 7% (Ref. 4).
B. Benefits
EPA is not fully able to quantify the full monetary benefits that
would accrue from preventing all deaths due to methylene chloride in
paint and coating
[[Page 7489]]
removal. Similarly, EPA is not able to monetize the benefits that would
accrue from preventing non-fatal and non-cancer effects from exposure
to methylene chloride in paint and coating removal. The subset of
benefits that can be monetized from mitigating the risks from methylene
chloride in paint and coating removal for consumer uses and for the
commercial uses proposed for regulation are estimated to be $14,363,000
to $14,565,000 (annualized at 3% over 20 years) and $13,796,000 to
$13,921,000 (annualized at 7% over 20 years) (Ref. 4). Although the
alternatives considered are unlikely to result in the same health
benefits as the proposed option, EPA was unable to quantify the
differences.
C. Comparison of Benefits and Costs
The monetized subset of benefits for preventing the risks resulting
from methylene chloride in paint and coating removal by consumers and
by commercial workers for the uses proposed for regulation do not
outweigh the estimated monetary costs. EPA believes that the balance of
costs and benefits cannot be fairly described without considering the
additional, non-monetized benefits of mitigating the non-cancer adverse
effects as well as cancer. As discussed previously, the multitude of
potential adverse effects associated with methylene chloride in paint
and coating removal can profoundly impact an individual's quality of
life. Some of the adverse effects associated with methylene chloride
exposure can be immediately experienced and can result in sudden death;
others can have impacts that are experienced for a shorter portion of
life, but are nevertheless significant in nature. While the risk of
non-cancer health effects associated with methylene chloride exposure
during paint and coating removal cannot all be quantitatively
estimated, the qualitative discussion highlights how some of these non-
cancer effects may be as severe as cancer and thus just as life
altering. These effects include not only medical costs but also
personal costs such as emotional and mental stress that are impossible
to accurately measure. Considering only monetized benefits would
significantly underestimate the impacts of methylene chloride-induced
non-cancer adverse outcomes on a person's quality of life.
Thus, considering costs; the subset of benefits that can be
monetized (risk of cancer and risk of death in some sectors); and the
remaining benefits that cannot be quantified and subsequently monetized
(risk of nervous system effects, liver toxicity, reproductive effects,
and kidney toxicity), including benefits related to the severity of the
effects and the impacts on a person throughout a lifetime in terms of
medical costs, effects on earning power and personal costs, emotional
and psychological costs, and the disproportionate impacts on Hispanic
communities and individuals with limited English proficiency; the
benefits of preventing exposure to methylene chloride in paint and
coating removal by an estimated 1.3 million consumers and estimated
17,600 commercial workers for the uses proposed for regulation outweigh
the costs.
D. Impacts on the National Economy, Small Businesses, Technological
Innovation, the Environment, and Public Health
As described in Unit V.B. and in the Economic Analysis, EPA
considered the anticipated effects of this proposal on the national
economy. While the impacts of this rule as a whole are described in
Unit XXIII.C. and the impacts of the methylene chloride component of
this proposal are described in more detail in Unit VII.A. and in
Section 9.3 of the Economic Analysis (Ref. 4), EPA does not anticipate
these impacts having an effect on the overall national economy. EPA
anticipates that a majority of small businesses will have cost impacts
of less than one percent of the annual revenue, and the majority of
small business bathtub refinishing facilities and professional
contractors will have cost impacts greater than one percent of annual
revenue.
The proposed approach is anticipated to drive technological
innovation by formulators of paint and coating removal products
containing methylene chloride, as they continue to develop substitute
products, and refine such products already available. It is also
anticipated to drive technological innovation by formulators of
chemical paint and coating removal products with different chemistries
as well as manufacturers and retailers of alternative methods of paint
and coating removal. See also section 9.3 in the Economic Analysis
(Ref. 4).
The proposed approach is anticipated to have a positive impact on
public health, as described in Unit VI.D. There is anticipated to be a
positive impact on the environment, as a result of decreased use of
methylene chloride, which is a hazardous air pollutant, as described in
Unit III.A.
VIII. Uses of Methylene Chloride for Paint and Coating Removal Critical
for National Security
As part of interagency collaboration with the Department of Defense
(DOD) on this proposed rule, EPA is aware that there are specific
military uses for which methylene chloride is essential for paint and
coating removal and for which there are no technically feasible
alternatives currently available. The military readiness of DOD's
warfighting capability is paramount to ensuring national security,
which includes ensuring the maintenance and preservation of DOD's
warfighting assets. DOD has identified mission-critical uses for
methylene chloride for ensuring military aviation and vessel readiness.
These mission-critical items require the use of methylene chloride for
the removal of coatings from mission-critical corrosion-sensitive
components on military aviation and vessels, including safety-critical
components made of specialty metallic, nonmetallic, and composite
materials. As described in this section, EPA proposes to exempt these
uses from the regulations proposed on methylene chloride in paint and
coating removal. This exemption is proposed for an initial ten-year
period from the publication date of a final rule. EPA will engage with
DOD to identify any potential extension that may need to be granted, by
further rulemaking, after those ten years.
DOD has actively sought to reduce its use of methylene chloride in
paint and coating removal since 1990. DOD has replaced most of its
usage of methylene chloride for paint and coating removal with
mechanical methods, benzyl alcohol products, other solvents, and laser
ablation. For instance, the Navy's Fleet Readiness Center Southwest has
undertaken a successful 20-year effort and eliminated all but a single
use on safety-critical components. In an effort to reduce the use of
all HAPs such as methylene chloride, the Army has conducted tests to
identify and test the effectiveness of HAP-free paint and coating
removers on military high-performance coatings (Ref. 61). In another
example, the Air Force in December 2015 significantly reduced the use
of methylene chloride for removing coatings on flight control parts and
is now using substitute chemical products, primarily those with benzyl
alcohol formulations (Ref. 65). This phase-out was driven by worker
safety concerns and the destructive impact the methylene chloride
product had on the installation's industrial wastewater treatment
processes. The Air Force
[[Page 7490]]
sought alternatives for this use of methylene chloride for paint and
coating removal in this industrial process and was successful at
qualifying an alternative that met technical requirements (Ref. 65).
In light of these efforts to identify and adopt alternative
chemicals or methods, it is unlikely that DOD has overlooked potential
substitutes. DOD continues and will continue to pursue potential
substitutes. However, for mission-critical corrosion-sensitive
components on military aviation and vessels, including safety-critical
components, DOD has found that currently available substitute chemicals
for paint and coating removal have one or more technical limitations.
In these critical and essential applications, currently available
substitute chemicals cannot completely remove specific military high
performance or chemical resistant coatings, resulting in improperly
applied, incompletely adhering replacement coatings. The impacts of
this are early coating failure, corrosion of underlying critical parts,
shortened service life for critical components (some of which are no
longer manufactured), and reduced availability and mission readiness of
military aircraft and vessels.
Substitute chemicals currently available are also incompatible with
underlying metallic, nonmetallic and composite materials, resulting in
material damage to critical components (e.g. hydrogen embrittlement)
creating immediate damage or longer-term susceptibility to stress
fracturing and corrosion. The impacts of this are shortened service
life for critical components (some of which are no longer
manufactured), reduced availability and mission readiness of military
aircraft and vessels, and an increased risk of catastrophic failure of
safety critical parts.
Additionally, substitute chemicals or methods currently available
do not support the coating removal requirements of safety inspection,
non-destructive inspection, material assessment, or field repair
processes. This results in an inability to properly perform safety
inspections for critical components, leading to undetected fractures
and defects. The impacts of this are increased risk of catastrophic
failure of safety critical parts.
Under TSCA section 6(g)(1)(B), EPA may grant an exemption from a
requirement of a TSCA section 6(a) rule for a specific condition of use
of a chemical substance or mixture if compliance with the requirement
would significantly disrupt the national economy, national security, or
critical infrastructure. Based on discussions and information provided
by DOD, EPA has analyzed the need for the exemption and concurs with
DOD that compliance with the proposed regulations on the use of
methylene chloride in paint and coating removal would significantly
impact national security. DOD has demonstrated that the reduced mission
availability of aircraft and vessels for military missions or, in the
worst case, the loss of individual military aircraft and vessels, are
potential impacts to military readiness that could result from the
proposed prohibition of methylene chloride in paint and coating
removal. Due to the importance of these military systems for national
security, EPA has determined that these uses of methylene chloride for
removal of specialized coatings from military aviation and vessel
mission-critical corrosion-sensitive components, including safety-
critical components, is critical for national security and the safety
of personnel and assets. EPA includes in this exemption corrosion-
sensitive military aviation and vessel mission-critical components such
as landing gear, gear boxes, turbine engine parts, and other military
aircraft and vessel components composed of metallic materials
(specifically high-strength steel, aluminum, titanium, and magnesium)
and composite materials that not only require their coatings be removed
for inspection and maintenance but also would be so negatively affected
by the use of technically incompatible, substitute paint removal
chemicals or methods that the safe performance of the vessel or
aircraft could be compromised.
EPA proposes to grant this exemption for a period of 10 years from
the date of promulgation of a final rule, with a potential for
extension, by further rulemaking, after review by EPA in consultation
with DOD. The conditions for this exemption would be: (1) The use of
methylene chloride for coating removal by DOD or its contractors
performing this work only for DOD projects is limited to the mission-
critical corrosion-sensitive components on military aviation and
vessels, including safety-critical components; and (2) this paint and
coating removal must be conducted at DOD installations, at Federal
industrial facilities, or at DOD contractor facilities performing this
work only for DOD projects. This exemption granted under
TSCA(6)(g)(1)(B) does not impact or lessen any requirements for
compliance with other statutes under which the use, disposal, or
emissions of methylene chloride is regulated.
As described in Unit VI.C.3., under the proposed approach, any
paint and coating removal products containing methylene chloride would
be required to be distributed in packaged volumes no less than 55-
gallon containers. As part of the exemption for uses identified as
critical for national security, for those formulations specifically
manufactured for DOD, suppliers may provide paint and coating removal
products containing methylene chloride to DOD in containers with a
volume no less than 5 gallons. Allowing selective use for national
security purposes does not disrupt the efficacy of the supply chain
approach described in Unit VI.C.3.
In addition to the exemption described in this unit, EPA will
consider granting additional time-limited exemptions, under the
authority of TSCA section 6(g), for a specific condition of use for
which EPA can obtain documentation: that the specific condition of use
is a critical or essential use for which no technically and
economically feasible safer alternative is available, taking into
consideration hazard and exposure; that compliance with the proposed
rule would significantly disrupt the national economy, national
security, or critical infrastructure. To this end, EPA requests comment
on a process for receiving and evaluating petitions and requesting EPA
promulgate critical-use exemption rules. Under this process, entities
who believe that their specific condition of use is a critical or
essential use under TSCA section 6(g) would submit a petition for an
exemption rulemaking with supporting documentation that they believe
demonstrates that the use meets the statutory criteria. EPA would
review the petition for completeness and, if the documentation warrants
further action, respond to the petition by publishing a proposal in the
Federal Register inviting comment on a proposed exemption. EPA would
consider the comments received, along with any additional information
reasonably available, and then take final action on the proposed
exemption. EPA requests comment on the specific kinds of documentation
that should be required from entities seeking an exemption rulemaking
in order to facilitate EPA's and later, the public's review. EPA also
requests comment on the appropriate timeframes for EPA action, given
that the documentation for any given use could be technical and
extensive, and that EPA may also need to develop additional
information, such as economic estimates, in order to promulgate an
exemption rule under TSCA section 6(g). Finally, members of
[[Page 7491]]
the potentially regulated community who believe that their operation is
a critical or essential use should provide as much detail as possible
to EPA about their operation during this comment period, including
information on any evaluations of alternatives, the costs to transition
to another chemical or process, and any other relevant information.
This would assist EPA in reviewing the specific condition of use, as
well as in establishing provisions for future exemption petitions.
IX. Overview of Uncertainties for Methylene Chloride in Paint and
Coating Removal
A discussion of the uncertainties associated with this proposed
rule can be found in the methylene chloride risk assessment (Ref. 2)
and in the additional analyses for methylene chloride in commercial and
consumer paint and coating removal (Refs. 19, 20, and 38). A summary of
these uncertainties follows.
EPA used a number of assumptions in the methylene chloride risk
assessment and supporting analysis to develop estimates for
occupational and consumer exposure scenarios and to develop the hazard/
dose[hyphen]response and risk characterization. EPA recognizes that the
uncertainties may underestimate or overestimate actual risks. These
uncertainties include the likelihood that releases of and exposures to
methylene chloride vary from one paint and coating removal project to
the next. EPA attempted to quantify this uncertainty by evaluating
multiple scenarios to establish a range of releases and exposures. In
estimating the risk from methylene chloride in paint and coating
removal, there are uncertainties in the number of workers, bystanders,
and consumers exposed to methylene chloride and in the inputs to the
models used to estimate exposures.
In addition to the uncertainties in the risks, there are
uncertainties in the cost and benefits. The uncertainties in the
benefits are most pronounced in estimating the benefits from preventing
deaths due to methylene chloride that have been underreported in most
commercial sectors. Additional significant uncertainties in benefits
include the entirety of prevention of the non-cancer adverse effects,
including underreported deaths (described in Unit VI.E.), because these
benefits generally cannot be monetized due to the lack of concentration
response functions in humans leading to the ability to estimate the
number of population-level non-cancer cases and limitations in
established economic methodologies. Additional uncertainties in benefit
calculations arose from EPA's use of a forecast from an industry expert
to estimate the categories of alternatives that users might choose to
adopt and the potential risks for adverse health effects that the
alternatives may pose. While there are no products or methods that have
comparable cancer or lethal risks, these substitute products and
alternative methods do present hazards. Without information on what
alternative methods or chemicals users of methylene chloride for paint
and coating removal are likely to switch to, and estimates of the
exposures for those alternatives, EPA is unable to quantitatively
estimate any change in non-cancer risks due to use of substitute
chemicals or alternative methods instead of using methylene chloride
for commercial or consumer paint and coating removal.
Additional uncertainties include any benefits accrued by commercial
users of methylene chloride for paint and coating removal who would
benefit from using substitute chemicals and alternative processes.
These users would be able to reduce or eliminate costs incurred for
emissions control, hazardous waste disposal, or wastewater treatment,
which are all required for commercial users of methylene chloride for
any purpose.
In addition to these uncertainties related to benefits, there are
uncertainties related to the cost estimates. As noted earlier, there is
uncertainty in EPA's estimates of which chemical substitutes or
alternative methods users may adopt instead of methylene chloride for
paint and coating removal, which in turn produces uncertainty as to the
cost of those substitutes or methods. EPA has estimated the cost of
substitute chemicals, and, in some sectors, some increase in costs due
to increased labor required by some substitute methods, but is not able
to fully characterize the total costs to all sectors for using
substitute chemicals or alternative products. It is possible that some
users with paint removal projects that require removing multiple layers
of coatings may ultimately save time by switching to a substitute
chemical that is more effective than methylene chloride for this
particular use. However, changes in time gained or lost during paint
and coating removal projects cannot be estimated for all users
potentially affected by this proposed rule. In addition, under certain
assumptions EPA's economic analysis estimates that some users of
methylene chloride for paint and coating removal will see a cost
savings when switching to substitutes. Standard economic theory
suggests that financially rational companies would choose technologies
that maximize profits so that regulatory outcomes would not typically
result in a cost savings for the regulated facilities. There could be
several reasons that cost savings might occur in the real world.
Potential reasons include lack of complete information or barriers to
obtaining information on the cost savings associated with alternatives
as well as investment barriers or higher interest rates faced by firms.
Additionally, there may be costs associated with these alternatives
that are not adequately accounted for in the analysis. To evaluate the
effect of this uncertainty, EPA has included a sensitivity analysis
that sets the cost savings to zero for these compliance alternatives
(Ref. 4 at Section 7). EPA also recognizes that these firms might
experience positive costs of compliance rather than zero costs, so that
the actual total costs could be higher than those in the sensitivity
analysis. However, EPA has no current basis to estimate these
potentially higher costs, since the available data appear to show that
there are lower cost substitutes available. EPA requests comments on
these assumptions.
Additionally, there are uncertainties due to the estimates of the
number of affected commercial and consumer users, and for numbers of
processors and distributors of methylene chloride-containing products
not prohibited by the proposed rule who are required to provide
downstream notification and/or maintain records.
EPA will consider additional information received during the public
comment period. This includes scientific publications and other input
submitted to EPA during the comment period.
X. Major Provisions and Enforcement of the Proposed Rule for Methylene
Chloride in Paint and Coating Removal
This proposal relies on general provisions in the proposed Part
751, Subpart A, which can be found at 81 FR 91592 (December 16, 2016).
A. Prohibitions and Requirements
The rule, when final, would (1) prohibit the manufacturing,
processing, and distribution in commerce of methylene chloride for
paint and coating removal for consumer uses and for all commercial uses
excluding for commercial furniture refinishing (see Unit XI.) and
exempting those defined as critical for national security (see Unit
VIII.); (2) prohibit commercial use of methylene chloride for paint and
coating removal except for commercial
[[Page 7492]]
furniture refinishing and for uses defined as critical for national
security; (3) require any paint and coating removal products containing
methylene chloride to be distributed in containers with a volume no
less than 55-gallons, except for formulations manufactured specifically
for the Department of Defense; (4) require manufacturers, processors,
and distributors of methylene chloride and all products containing
methylene chloride, excluding retailers, to provide downstream
notification of the prohibitions; and (5) require recordkeeping
relevant to these prohibitions. As described in Unit XI., EPA intends
to issue separately a proposal to regulate the risks presented by
methylene chloride in commercial furniture refinishing so that those
risks are no longer unreasonable; EPA intends to finalize that separate
proposal and this proposal together.
The prohibition on manufacturing, processing, and distributing in
commerce methylene chloride for consumer paint and coating removal
would take effect 180 days after publication of a final rule.
Similarly, the prohibition on manufacturing, processing, and
distributing in commerce methylene chloride for any non-prohibited
paint and coating removal commercial uses in containers with volumes
less than 55 gallons would take effect 180 days after publication of a
final rule. The prohibition on commercial use of methylene chloride for
paint and coating removal except in furniture refinishing or for
critical national security uses would take effect 270 days after
publication of a final rule. These are reasonable transition periods
because, as noted in Unit VI.E. and by the small businesses
participating in the SBAR process, many formulators of paint and
coating removers containing methylene chloride also manufacture
products for this use that do not contain methylene chloride (Ref. 27).
In addition, alternative paint removal products exist at comparable
expense for users to purchase. Six months from publication of the final
rule is sufficient time to allow for existing stocks to move through
the market place and to allow manufacturers, processers and
distributors and users to plan for and implement product substitution
strategies.
B. Downstream Notification
EPA has authority under TSCA section 6 to require that a substance
or mixture or any article containing such substance or mixture be
marked with or accompanied by clear and adequate minimum warnings and
instructions with respect to its use, distribution in commerce, or
disposal or with respect to any combination of such activities. Many
manufacturers and processors of methylene chloride are likely to
manufacture or process methylene chloride or products containing
methylene chloride for other uses that would not be regulated under
this proposed rule. Other companies may be strictly engaged in
distribution in commerce of methylene chloride, without any
manufacturing or processing activities, to customers for uses that are
not regulated. EPA is proposing a requirement for downstream
notification by manufacturers, processors, and distributors of
methylene chloride for any use to ensure compliance with the
prohibition on manufacture, processing, distribution in commerce, and
commercial use of methylene chloride for the uses proposed for
regulation. Downstream notification is necessary for effective
enforcement of the rule because it provides a record, in writing, of
notification on use restrictions throughout the supply chain, likely
via modifications to the Safety Data Sheet. Downstream notification
also increases awareness of restrictions on the use of methylene
chloride for paint and coating removal, which is likely to decrease
unintentional uses of methylene chloride by these entities. Downstream
notification represents minimal burden and is necessary for effective
enforcement of the rule. The estimated cost of downstream notification
on an annualized basis over 20 years is $40 and $60 using 3% and 7%
discount rates respectively (Ref. 4).
The effective date of the requirement for this notification would
be 45 days after publication of the final rule. This is a reasonable
transition period because regulated entities would only need to provide
additional information on their SDS, which are routinely produced and
updated.
C. Enforcement
Section 15 of TSCA makes it unlawful to fail or refuse to comply
with any provision of a rule promulgated under TSCA section 6.
Therefore, any failure to comply with this proposed rule when it
becomes effective would be a violation of section 15 of TSCA. In
addition, section 15 of TSCA makes it unlawful for any person to: (1)
Fail or refuse to establish and maintain records as required by this
rule; (2) fail or refuse to permit access to or copying of records, as
required by TSCA; or (3) fail or refuse to permit entry or inspection
as required by section 11 of TSCA.
Violators may be subject to both civil and criminal liability.
Under the penalty provision of section 16 of TSCA, any person who
violates section 15 could be subject to a civil penalty for each
violation. Each day in violation of this proposed rule when it becomes
effective could constitute a separate violation. Knowing or willful
violations of this proposed rule when it becomes effective could lead
to the imposition of criminal penalties for each day of violation and
imprisonment. In addition, other remedies are available to EPA under
TSCA.
Individuals, as well as corporations, could be subject to
enforcement actions. Sections 15 and 16 of TSCA apply to ``any person''
who violates various provisions of TSCA. EPA may, at its discretion,
proceed against individuals as well as companies. In particular, EPA
may proceed against individuals who report false information or cause
it to be reported.
XI. Furniture Refinishing (Methylene Chloride)
At this time, following input from small entity representatives
received during the SBAR process, and based on the SBAR panel
recommendations, EPA is not proposing to regulate methylene chloride
when used in paint and coating removal in commercial furniture
refinishing, also referred to as professional furniture refinishing
(Ref. 27). Although EPA proposes to determine that risks to workers
using methylene chloride for commercial furniture refinishing are
unreasonable, EPA is seeking additional information about this industry
to inform development of future proposed restrictions on methylene
chloride in commercial furniture refinishing.
A. Description of Commercial Furniture Refinishing
Commercial furniture refinishing consists of several processes,
including but not limited to repair, reupholstery, repainting, and
depainting or removing paints and coatings, sometimes referred to as
furniture stripping. EPA has defined furniture stripping as paint and
coating removal from furniture; it includes application of a chemical
or use of another method to remove, loosen, or deteriorate any paint,
varnish, lacquer, graffiti, surface protectants, or other coating from
wood, metal, or other types of furniture, doors, radiators, or
cabinets. Furniture stripping can be conducted separately or as a part
of furniture refinishing. EPA has defined commercial furniture
stripping as furniture stripping conducted in a commercial facility
performed by an
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individual, government entity, or company for which an individual,
government entity, or company receives remuneration or other form of
payment.
As described in the methylene chloride risk assessment, to carry
out furniture stripping, or to remove paint, lacquer, varnish, or other
coatings from wood or metal furniture (or similar items such as doors,
radiators, and cabinets), chemical paint and coating removal products
may be applied to the furniture by either dipping the furniture in an
open tank containing the chemicals, brushing or spraying the product
onto the furniture surface, or manually applying the chemical product
with a brush, rag, or aerosol spray. Larger furniture refinishing
facilities conducting furniture stripping may pump the chemical product
through a brush. The application method depends on the size and
structure of the furniture as well as the capabilities of the facility
(Ref. 2). Some firms may use alternative methods of paint and coating
removal, such as sanding or heat/thermal guns, but EPA's information to
date indicates that paint and coating removal on furniture is primarily
conducted with chemical removers (Refs. 22, 27, 31, 66 and 27).
The area where furniture refinishing workers conducting furniture
stripping apply paint and coating removal chemicals typically has a
sloped surface to allow for collection and recycling of unused chemical
product. Larger facilities use a flow tray to apply the paint and
coating removal product or chemical to parts. The flow tray is a
sloped, shallow tank with a drain at the lower end. Some facilities may
use a dip tank to immerse whole pieces or parts of furniture in the
chemical product (Refs. 2 and 22).
After a worker applies the chemical product or immerses the piece
of furniture in it, the paint and coating remover is left to soak, or
``dwell,'' on the furniture surface to soften the paint, coating, or
varnish. Once soaking is complete, a worker manually scrapes or brushes
the unwanted coating from the furniture surface. The worker then
transfers the furniture to a washing area where they wash the waste
chemical and paint or coating sludge from the furniture. Workers can
wash the treated furniture with low-pressure washing operations or
high-pressure water jets or high-pressure wands. Wash water may contain
oxalic acid to brighten the wood surface. Wash water is collected and
either recycled or disposed of as waste. After washing, the worker
transfers the furniture to a drying area where it is allowed to dry
before being transferred to other refinishing processes (e.g., sanding,
painting, reupholstery) (Ref. 2).
Based on industry research and discussions with stakeholders, EPA
is aware that most commercial furniture refinishing firms primarily use
chemical methods for paint and coating removal, and that methylene
chloride or methylene chloride-based products are the types of chemical
paint removers primarily and, in some firms, exclusively, used. Some
commercial furniture refinishers, including some small businesses
participating in the SBAR process, have said that although they make
limited use of acetone for some types of furniture, they have not found
any workable substitutes for methylene chloride as a primary paint and
coating removal method (Refs. 22 and 27). More information on the
potential use of substitutes for furniture refinishing is provided in
Unit XI.E.
B. Risks Associated With Furniture Refinishing
The methylene chloride risk assessment and additional supplemental
analyses identified acute and chronic risks from inhalation of
methylene chloride during paint and coating removal by consumers,
commercial users, and bystanders in residences or workplaces
(individuals not using the paint and coating remover but nearby a user)
(Refs. 2, 19, 20, and 38). This includes an assessment of the risks
from methylene chloride when used in commercial furniture refinishing.
EPA estimates that, annually, there are approximately 15,000 workers at
4,900 commercial refinishing operations conducting paint and coating
removal with methylene chloride (Ref. 4).
1. Exposures assessed to methylene chloride during commercial
furniture refinishing and immersion stripping. Exposures assessed for
workers in commercial furniture refinishing include acute and chronic
exposures to methylene chloride for paint and coating removal, as
described in the methylene chloride risk assessment (Ref. 2). The
exposure pathways of interest included dermal contact and inhalation,
but, due to limitations described in the risk assessment, the
assessment was based only on the inhalation route of exposure.
Different exposure scenarios were evaluated for workers, occupational
bystanders, consumers, and residential bystanders (Ref. 2). Not
included in the assessment but important to note are bystanders in
commercial refinishing operations that are located in workshops or
other parts of residences; here, the bystanders may include not only
workers but also children and occupants of the home.
In addition to estimating likely exposures under current use
patterns, 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 varied between scenarios and
included engineering controls and use of personal protective equipment
(PPE), as 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 using local exhaust ventilation (LEV)
to improve ventilation near the activity of workers in furniture
refinishing operations, with an assumed 90% reduction in exposure
levels.
Overall, EPA evaluated several distinct exposure scenarios for
paint and coating removal with methylene chloride for commercial
furniture refinishing. Additionally, EPA evaluated several distinct
exposure scenarios for miscellaneous paint and coating removal
conducted by immersion of the object in vats or tanks of methylene
chloride (dip methods), since this has been reported as a method of
paint and coating removal during furniture refinishing (Refs. 19 and
27).
The results of these evaluations of exposure scenarios demonstrate
that the scenarios meeting all relevant health benchmarks for all
scenarios of methylene chloride in paint and coating removal in
commercial furniture refinishing requires: (1) A respiratory protection
program using a supplied-air respirator with APF of 1,000 or 10,000,
depending on type of method used for applying methylene chloride or
workplace characteristics, such as the size of the facility; (2)
reducing exposures with LEV that can achieve 90% efficiency in air flow
plus worker respiratory protection with APF 1,000; or (3) elimination
of exposure to methylene chloride by using an alternative method of
paint and coating removal (Ref. 19). Although non-cancer risks and
cancer risks were estimated using separate measures, exposure
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reduction that is protective against non-cancer risks from methylene
chloride is also protective against cancer risks.
2. Risks assessed from methylene chloride during commercial
furniture refinishing and immersion methods. Exposure to methylene
chloride is associated with death, neurotoxicity, liver toxicity, and
cancer in humans and animals. To estimate non-cancer risks for acute
and chronic exposures, the methylene chloride risk assessment used
MOEs. Exposure scenarios with MOEs below the benchmark MOE have risks
of concern, as explained in detail in the methylene chloride risk
assessment. For acute and chronic exposure scenarios, the benchmark MOE
is 10 (Ref. 2). The benchmark MOE identifies a risk of concern for a
given endpoint; it is obtained by multiplying the total uncertainty
factors associated with each health endpoint's point of departure. For
more information on uncertainty factors, see Unit IV.B.
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. A risk of concern was identified if the MOE estimate was less
than the benchmark MOE of 10 (Ref. 2).
EPA assessed acute risks for central nervous system effects from
inhalation for workers using methylene chloride for commercial
furniture refinishing and for immersion methods of paint and coating
removal for various objects, including furniture. Acute risks were
estimated in this sector, even in the presence of respirators with APF
10 or APF 25. MOEs for acute risks in commercial furniture refinishing
ranged from a central tendency of 0.08 to 0.035, with a high 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 125 times to greater than 1,500 times more than
those that are expected to produce no risks 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.
EPA also assessed risks of chronic exposure to workers using
methylene chloride for commercial furniture refinishing. The methylene
chloride risk assessment used liver toxicity as the critical endpoint
for chronic exposure. The selected exposure scenarios represented
inhalation exposures with a range of conservative assumptions. As
described earlier, the assumptions were then varied, such as use of PPE
(supplied-air or other respirator) and duration of time spent in
contact with the product (days and years). EPA assessed risks for liver
toxicity (with effects that include vacuolation and fatty liver) for
occupational and bystander exposure scenarios of paint and coating
removal with methylene chloride.
Workers and occupational bystanders in this industry were estimated
to be at risk of non-cancer liver toxicity as a result of chronic
exposure to methylene chloride during paint and coating removal under
typical exposure scenarios. When workers' exposures were estimated at
facilities repeatedly reporting moderate or high methylene chloride air
concentration levels, EPA estimated that there were risks of concern
for these workers, even for scenarios evaluated with workers wearing
respiratory protection with APF 50. Among all of the occupational
scenarios, the greatest risk of 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 those workers, MOEs for chronic exposures
were 0.025, or reflective of risks 400 times greater than the
benchmark. Even for workers assumed to have lower exposure, MOEs did
not reach 10. In most workplaces engaged in commercial furniture
refinishing, MOEs for chronic exposure ranged from a central tendency
of 0.60 to 0.3. Additionally, in EPA's risk assessment scenarios, which
are not necessarily reflective of industry-wide work practices, for
workers and bystanders assumed to have the lowest exposure (respirator
APF 50, limited exposure duration, and moderate air concentration),
MOEs for chronic exposure were 5, or one-half of the benchmark (Ref.
2).
For commercial users and bystanders, EPA also assessed cancer risks
as a result of chronic exposure to methylene chloride in paint and
coating removal in commercial furniture refinishing. Methylene chloride
is a likely human carcinogen; cancer risks determine the incremental
increased probability of an individual in an exposed population
developing cancer over a lifetime following exposure to the chemical
under specified use scenarios. Common cancer benchmarks used by EPA and
other regulatory agencies are an increased cancer risk of one in one
million or one in ten thousand (i.e., 1 x 10-\6\ or 1 x
10-\4\). Estimates of cancer risk should be interpreted as
the incremental increased probability of an individual in an exposed
population developing cancer over a lifetime as a result of exposure to
the potential carcinogen (i.e., incremental or excess individual
lifetime cancer risk) (Ref. 2).
In the methylene chloride risk assessment, when exposure for
workers and occupational bystanders was estimated in facilities
conducting commercial furniture refinishing, EPA identified excess
cancer risks if these workers and bystanders were exposed to paint and
coating removal with methylene chloride for 250 days per year for 40
years with no respiratory protection. Cancer risks ranged from 2 in
10,000 to 8 in 10,000, with a maximum of 5 in 1,000 (workplaces using
immersion methods) (Ref. 2).
For commercial users and occupational bystanders in commercial
furniture refinishing, acute and chronic risks were assessed based on
the typical occupational exposure parameters, which may include several
hours per day of exposure over several years of work. For these
reasons, any risk mitigation measures must address not only acute
risks, but also chronic risks, including both cancer and non-cancer
effects. For these reasons, the most sensitive endpoint for risk
mitigation must be considered, whether it derives from acute or chronic
exposure.
3. Impacts of the exposures. As discussed for other commercial uses
in Unit VI.E., exposure to methylene chloride in paint and coating
removal, when conducted in commercial furniture refinishing and for
other purposes, is associated with a range of adverse health effects,
which include impacts on the nervous system, liver, respiratory system,
kidneys, and reproductive systems. In some instances, these effects may
appear relatively mild, such as dizziness, which occurs early in
exposure and at low exposure levels. However, with increasing levels of
exposure or increasing duration, these effects can take the form of
generally irreversible health effects such as cognitive impairment,
sensory impairment, coma, heart failure, liver toxicity, brain cancer,
liver cancer, non-Hodgkin lymphoma, and multiple myeloma.
Acute exposure to methylene chloride during paint and coating
removal can be fatal; since 1980, at least seven workers have died
while using methylene chloride for commercial furniture refinishing.
Data from OSHA indicate that the circumstances of death vary. For
example, some workers collapse while conducting paint and coating
removal over or near dip tanks, frequently falling into the tanks and
subsequently dying. This was the case in 1985 in Pennsylvania, 1986 in
Colorado, 1990 in Connecticut, and
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2000 in Pennsylvania (Ref. 7). The worker in Connecticut earlier
complained that the vapors were making him dizzy, and shortly after
slumped into the dip tank and died; the worker in 2000 in Pennsylvania
was found face-down in the dip tank next to the shutters from which he
was attempting to remove paint (Ref. 7). Other workers in commercial
furniture refinishing facilities lose consciousness at their workplace,
but die sometime later, such as a worker in 1991 in Colorado, and in
1999 in Tennessee (Ref. 68).
These are likely not the only deaths in commercial furniture
refinishing due to methylene chloride; as discussed in Unit VI.E., many
deaths due to methylene chloride have not been recorded due to a lack
of reporting to the OSHA incident database by self-employed individuals
and the likelihood that deaths due to methylene chloride exposures are
misattributed to heart disease, since the pathology is similar (Ref.
33).
In addition to fatalities, methylene chloride exposure during
commercial wood refinishing has caused acute effects, such as the 1996
case of a cabinet manufacturer employee who experienced chronic
headaches found to be due to methylene chloride exposure when the doors
at his facility were closed in the winter months (Ref. 69).
In most commercial furniture refinishing facilities using methylene
chloride for paint and coating removal, worker and occupational
bystander exposure concentrations are orders of magnitude above what
would be necessary to achieve the benchmark MOE of 10 for acute and
chronic non-cancer effects. For acute health effects such as nervous
system impacts, EPA estimated an MOE of 0.08 for workers in commercial
furniture refinishing. For chronic non-cancer health effects such as
liver toxicity, workers in this industry have an MOE of 0.6 to 0.3
(Ref. 2). For a description of MOEs and their use in risk assessment,
see Unit IV.B.
In each case, workers in commercial furniture refinishing using
methylene chloride for paint and coating removal are exposed at a level
that is generally 125 to 1,500 times higher than what EPA has found to
be a level that would not present acute or chronic non-cancer risks of
concern. These risks of concern are for effects such as death, multiple
adverse chronic health effects, and the subsequent lifetime impacts
from these effects. Additionally, individuals occupationally exposed to
methylene chloride in paint and coating removal may also be impacted by
an increased risk for several types of cancer. The cancer risks to
workers in commercial furniture refinishing using methylene chloride
for paint and coating removal range from 8 cases in 10,000 people to 5
cases in 1,000 people (workplaces using immersion methods) (Ref. 2).
EPA's risk estimates are corroborated by research conducted
independently investigating working conditions at commercial furniture
refinishing and OSHA enforcement of their methylene chloride standard.
In 1990, as a result of several cases of methylene chloride poisoning
during paint and coating removal in commercial furniture refinishing in
Colorado, occupational medicine specialists from the University of
Colorado surveyed the 21 small shops in the Denver area engaged in
commercial furniture refinishing. These researchers found that of the
21 shops, no workers wore respirators at all in seven shops, and in 14
facilities, workers occasionally wore half-face respirators with
organic vapor cartridges (which do not provide respiratory or eye
protection from methylene chloride). In ten of the 21 shops, workers
experienced acute nervous system effects, such as dizziness or nausea
while working to remove coatings from furniture. The researchers
concluded that ``current safety practices in small-scale furniture-
stripping shops may be inadequate to keep methylene chloride exposure
levels in compliance with latest recommendations, and serious or fatal
overexposure can occur'' (Ref. 70).
When considering the benefits of preventing exposure to methylene
chloride in paint and coating removal in commercial furniture
refinishing, EPA considered the type of effect, the severity of the
effect, the duration of the effect, and costs and other impacts of the
health endpoint. The health endpoints associated with exposure to
methylene chloride are serious. Unit VI.E. presents a detailed
discussion of the impacts of the most significant acute, chronic non-
cancer, and cancer effects associated with methylene chloride exposure
during paint and coating removal, including the severity of the effect,
the manifestation of the effect, and how the effect impacts a person
during their lifetime. These effects include nervous system effects
resulting from acute exposures, such as sensory impairment,
incapacitation (loss of consciousness), and death; and effects
resulting from chronic, occupational exposures including liver toxicity
and liver cancer, hematopoietic cancers, brain cancer, lung cancer,
reproductive effects, and kidney toxicity.
There are increased risks of death, nervous system effects, and
liver, lung, brain, reproductive, and kidney effects for the
approximately 15,000 workers in 4,900 commercial facilities or
companies that use methylene chloride for paint and coating removal
during commercial furniture refinishing each year (Ref. 4).
C. Approaches That Could Reduce the Risks of Methylene Chloride Used in
Furniture Refinishing to Benchmark Levels
Although EPA is not proposing to regulate the use of methylene
chloride in paint and coating removal for commercial furniture
refinishing, EPA has identified potential requirements for methylene
chloride in paint and coating removal for commercial furniture
refinishing that could reduce exposures so that the risks presented
would no longer be unreasonable. EPA is providing advanced notice of
these potential approaches and is seeking comment on them.
1. Prohibition on manufacturing, processing, distribution, and use
of methylene chloride in commercial furniture refinishing. Similar to
the approach proposed for regulation of methylene chloride in other
commercial paint and coating removal (see Unit V.), EPA has identified
a prohibition on manufacturing, processing, distribution, and use of
methylene chloride in commercial furniture refinishing as an option for
reducing risks in this industry to benchmark levels, under TSCA
sections 6(a)(2) and 6(a)(5). This approach could also require
manufacturers, processors, and distributors to provide downstream
notification of the prohibitions under TSCA section 6(a)(3), and could
require recordkeeping relevant to these prohibitions under TSCA section
6(a)(4).
Under this approach, exposures to methylene chloride during paint
and coating removal in commercial furniture refinishing would be
completely eliminated. As a result, not only non-cancer risks, but also
cancer risks would be eliminated.
2. Requiring a respiratory protection program, including PPE, air
monitoring, and either a supplied-air respirator of APF 1,000 or 10,000
or an air exposure limit of 1 part per million (ppm) achieved through
engineering controls or ventilation, in commercial facilities for
furniture refinishing using methylene chloride for paint and coating
removal under TSCA section 6(a)(5). Another regulatory approach that
EPA has considered for the use of methylene chloride for paint and
coating removal in commercial furniture refinishing would be to require
risk reduction through an occupational respiratory
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protection program, which would include air monitoring, medical
monitoring, and respiratory protection through use of a supplied-air
respirator with an APF of 1,000 or 10,000, depending on the methods
used for paint and coating removal with methylene chloride and other
workplace characteristics, with a performance-based option of meeting
an air concentration level of 1 ppm as an exposure limit for methylene
chloride.
A full-face (or helmet/hood) self-contained breathing apparatus
(SCBA) when used in the pressure demand mode or other positive pressure
mode has an APF of 10,000. EPA's analysis found that use of a SCBA with
an APF of 10,000 would, in all scenarios evaluated, control the
methylene chloride exposure to levels that allow for meeting the
benchmarks for non-cancer and cancer risks. In some commercial
furniture refinishing facilities using methylene chloride for paint and
coating removal, workers with a supplied-air respirator with an APF of
1,000 would experience reduced exposures to methylene chloride such
that their risks would be reduced to benchmark levels (Ref. 19). It is
important to note that current OSHA requirements for dermal and eye
protection when using methylene chloride in any way would be maintained
under this approach, in addition to other requirements for work
practices, training, and hazard communication put forth in OSHA's
Methylene Chloride Standard (29 CFR 1910.1052).
EPA seeks comment on whether commercial furniture refinishing
operations have these types of respiratory protection programs in
place, any experiences in complying with the current OSHA methylene
chloride standard, methods of reducing costs associated with these
programs, and recommended approaches for small businesses considering a
respiratory protection program that would include supplied-air
respirators.
EPA also considered requiring a combination of local exhaust
ventilation and respirators with APF of 1,000 or 50, with a
performance-based option of an air exposure limit of 1 ppm as an eight-
hour TWA. When properly executed, this option would reduce risks to the
health benchmarks for workers and bystanders (Refs. 19 and 38).
However, while this option has the benefit of incorporating engineering
controls and the use respirators with a lower APF, the limitations to
successful implementation of the use of supplied-air respirators in the
workplace discussed previously are still present.
Further, this option would also require the use of prescriptive and
expensive engineering controls to ensure that the exposures are below
the benchmark cancer risks (Ref. 19). In an examination of the impacts
of its methylene chloride standard, OSHA in 2010 found that furniture
refinishing facilities in particular have not installed ventilation
systems that would lower worker exposures to methylene chloride (Ref.
68). OSHA's assessment found that this is largely due the fact that
most of these facilities are part of small businesses, and they tend to
be less able to have sufficient capital to purchase the ventilation
systems. Additionally, this type of ventilation requires make-up air
systems, which have an additional cost and which, in cold climates,
would need to heat the air and thus increase energy costs (Ref. 68).
Even if these engineering controls were installed, research
conducted by the National Institutes of Occupational Safety and Health
(NIOSH), as well as independent researchers, has indicated that
ventilation alone is generally not able to reduce methylene chloride
exposures below 25 ppm (Refs. 68 and 71), and there is no indication
that a level close to 1 ppm (an acceptable exposure limit) could be
reached.
3. Approaches that do not mitigate the risks of methylene chloride
in commercial furniture refinishing to benchmark levels. As described
in Units IV.B. and IV.C., EPA evaluated dozens of distinct exposure
scenarios across consumer and commercial uses of methylene chloride for
paint and coating removal, including in commercial furniture
refinishing. The results of EPA's evaluation indicate that regulatory
approaches for occupational exposures in commercial furniture
refinishing 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 for non-cancer endpoints for acute
and chronic exposures and standard cancer risk benchmarks for chronic
exposures (Refs. 26 and 29). The results also demonstrate that all risk
reduction options meeting the benchmark MOEs and cancer benchmarks for
methylene chloride in paint and coating removal in commercial furniture
refinishing require the use of a supplied-air respirator, whether used
alone or in conjunction with additional levels of protection.
Therefore, EPA found that setting a maximum concentration of methylene
chloride in products under section 6(a)(2) could not reduce exposures
so that risks from paint and coating removal with methylene chloride in
commercial furniture refinishing would be reduced to benchmark levels.
Options found not to meet the risk benchmarks are documented in EPA's
supplemental technical reports on methylene chloride in paint and
coating removal (Refs. 19, 20, 21, and 38).
D. Costs of EPA's Potential Approach for Regulation
EPA is at this time seeking additional information to inform its
consideration of the reasonably ascertainable economic consequences of
an action that would address the risks of commercial furniture
refinishing so that they are no longer unreasonable, as required under
TSCA section 6(c)(2)(A)(iv). This section presents the information EPA
currently has and identifies the information that EPA is seeking. While
the costs of potential risk management actions are not a legally
permissible basis for EPA to reassess its proposed unreasonable risk
determination, see TSCA section 6(b)(4)(A), costs are relevant to
deciding among alternative risk management approaches that reduce risk
so that a chemical substance no longer presents unreasonable risk and
in establishing compliance dates for a risk management approach that is
ultimately selected.
1. Information available to EPA. Based on industry research and
information provided by stakeholders, including during informal
discussions and more formally from small entity representatives
participating in the SBAR process (described in more detail in Unit
XXIII.), EPA has learned that there may not be any substitute chemicals
or alternative practices frequently in use for paint and coating
removal in commercial furniture refinishing other than chemical paint
and coating removal with methylene chloride (Refs. 22 and 27).
Primary chemical substitutes for methylene chloride in commercial
paint and coating removal more generally include products formulated
with benzyl alcohol; dibasic esters; acetone, toluene, and methanol
(ATM); and caustic chemicals. These substitute chemicals, their
hazards, and their environmental impacts are described in more detail
in Unit VI.E. EPA has learned that these chemicals are generally not
suitable for paint and coating removal in furniture refinishing since
they either are ineffective at removing particular coatings frequently
found on furniture (such as varnish, lacquer, or older paint
formulations in multiple layers); are formulated to include large
amounts of water and thus
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incompatible with wood objects that can become saturated and damaged
(as is the case with many products containing benzyl alcohol); or are
chemically incompatible with wood and can result in damage or raising
the grain on the object (as is the case with caustic paint and coating
removal products) (Refs. 22 and 27). Products that may be chemically
compatible with wood substrates or the paints, varnishes, or lacquers
to be removed were described by stakeholders as requiring too long a
dwell time to be efficacious for their business and thus are not used
(Refs. 22 and 27). Other than two commercial furniture refinishers who
remove paints and coatings on some solid wood objects with either
immersion in 100% acetone or an acetone-toluene-methanol blend, no
commercial wood finishing firms reported using substitute chemicals
routinely for paint and coating removal, and none felt they were able
to completely eliminate use of methylene chloride, despite being aware
of the worker health and environmental impacts (Refs. 22 and 27).
In addition to substitute chemical products, EPA has identified
non-chemical methods for commercial paint and coating removal that can
be used more generally as alternatives to methylene chloride.
Frequently-used alternative methods to chemical paint and coating
removal include thermal removal, sanding, hydroblasting, abrasive
blasting, and laser removal (Refs. 22 and 27). These methods are
already frequently in use in various industries for paint and coating
removal (Refs. 22, 27, and 31); they and their acute and chronic
hazards to workers are described in more detail in Unit VI.E.
For commercial furniture refinishing, EPA has learned that all
firms engage in varying amounts of mechanical or hand-sanding but do
not consider it a primary method of paint and coating removal (Refs. 22
and 27). Additionally, despite the hand scraping or brushing that is
required to remove waste paint from furniture and other objects for
which methylene chloride has been used to remove paint or coatings,
most stakeholders described sanding as too time consuming or labor
intensive to use routinely as a primary method of paint and coating
removal. Additionally, though many other commercial sectors have
adopted various soft media blasting techniques for delicate substrates,
such as using soda blasting on fiberglass vehicle parts, EPA has not
found this to be a practice used in commercial furniture refinishing
(Refs. 22 and 27).
EPA is seeking additional information to inform its consideration
of the impacts on commercial furniture refinishing if use of methylene
chloride as a paint and coating remover were prohibited or restricted.
2. Information sought. To aid in identifying the economic impacts
on commercial furniture refinishers of any potential prohibition or
restriction on methylene chloride for paint and coating removal, EPA is
seeking the following information related to the approach that would
prohibit the use of methylene chloride for paint and coating removal in
furniture refinishing:
What percent of business for firms in this sector is paint
and coating removal, versus furniture repair, reupholstery, or other
furniture refinishing functions?
How likely is it that firms in this sector would close if
methylene chloride were prohibited from use in paint and coating
removal in this sector?
What would the impact be on this sector if all firms were
prohibited from using methylene chloride for paint and coating removal,
and thus any changes in work processes or dwell time would be
universally experienced?
Have firms had any success with substitute chemicals or
alternative methods of paint and coating removal? If not, which aspects
of the chemical or method renders the substitute or alternative
ineffective?
Related to the approach that would require a respiratory protection
program, including either a supplied-air respirator with either APF
1,000 or APF 10,000, or engineering controls or ventilation to reach an
exposure limit of 1 ppm:
What is the current experience of firms in this sector
with supplied-air respirators and/or engineering controls?
What is the current experience of firms in this sector
with ventilation systems, makeup-air systems, and other engineering
controls?
What types of exposures do workers in firms in these
sectors currently experience?
EPA has found that commercial furniture refinishing primarily uses
methylene chloride for paint and coating removal and that no current
chemical substitutes are seen as useful alternatives. However, in
recent decades, substitute products have been developed for other types
of paint and coating removal, and it is possible that new substitute
chemicals or products could be developed to address the special
coatings or substrates involved in commercial furniture refinishing.
Several formulators and research organizations are exploring
possibilities for efficacious and cost-effective substitute chemicals.
Additionally, outside of the United States, commercial furniture
refinishers have adopted methods that are alternatives to chemical
paint and coating removal. For example, most paint and coating removal
in Sweden is conducted by thermal methods, such as heat guns or heat
lamps, including for commercial furniture refinishing (Ref. 72). In
Denmark, firms engaging in commercial furniture refinishing are
reported to use large microwave furnaces, which can hold large pieces
of furniture (Ref. 73).
These alternative methods and the research into substitute
chemicals indicate that it is now and in the future may increasingly be
possible to remove paint and coatings from furniture without methylene
chloride. If that were the case, EPA would be able to more
straightforwardly identify the costs and impacts of any proposed
regulation of methylene chloride for paint and coating removal in
commercial furniture refinishing. EPA is seeking additional information
on the use and development of substitute chemicals and alternative
methods that would be useful in commercial paint and coating removal on
furniture, including information on:
What are the current considerations when selecting a paint
and coating removal chemical for furniture refinishing or refinishing
of other wood objects or surfaces?
What are the current considerations when selecting a paint
and coating removal method for furniture refinishing or refinishing of
other wood objects or surfaces?
Are there substitute chemicals or alternative methods in
use beyond what EPA has identified in this notice?
Are any new paint and coating removal product formulations
or chemistries under development?
Are any new paint and coating removal methods in
development for furniture refinishing, or refinishing of other wood
objects or surfaces?
E. Public Engagement To Identify Impacts and Alternatives
To learn more about paint and coating removal in furniture
refinishing, foreseeable impacts of any proposed regulations, and
alternatives to methylene chloride, EPA plans to hold a series of
stakeholder meetings. These meetings will focus on current practices
related to methylene chloride for paint and coating removal in
commercial furniture refinishing; any substitute chemicals or
alternative methods currently in use or under development;
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and current and best practices related to respiratory protection
programs and exposure reduction.
EPA will announce dates and locations of these meetings in a future
notice in the Federal Register as well as on EPA's Web site. EPA will
provide some of these meetings electronically by Webinar to maximize
public participation.
F. Next Steps
EPA views this section as an Advanced Notice of Proposed
Rulemaking, and intends to issue a Notice of Proposed Rulemaking
following the series of stakeholder meetings and further analysis on
the cost impacts of regulatory action on this industry. Following that
proposal and public comment period, EPA intends to finalize together
the regulations proposed and the future proposal related methylene
chloride in commercial furniture refinishing.
XII. Overview of NMP and Uses Subject to This Proposed Rule
A. What chemical is included in the proposed rule?
This proposed rule would apply to N-methylpyrrolidone (Chemical
Abstract Services Registry Number (CASRN) 872-50-4) when used in paint
and coating removal.
B. What are the uses of NMP and how can people be exposed?
NMP is a solvent used in a variety of industrial, commercial and
consumer use applications, including (Ref. 3):
Petrochemical processing, acetylene recovery from cracked
gas, extraction of aromatics and butadiene, gas purification, lube oil
extraction;
Plastics engineering, as a reaction medium for the
production of high-temperature polymers such as polyethersulfones,
polyamideimides and polyaramids;
Use in coatings, as a solvent for acrylic and epoxy
resins, polyurethane paints, waterborne paints or finishes, printing
inks, synthesis/diluent of wire enamels, coalescing agent;
Production of agricultural chemicals: Solvent and/or co-
solvent for liquid formulations;
Electronics cleaning: Cleaning agent for silicon wafers,
photoresist stripper, auxiliary in printed circuit board technology;
and
Industrial and domestic cleaning, including as a component
in degreasers and paint removers.
According to the 2012 CDR information, approximately 180 million
pounds of NMP were produced or imported into the U.S. that year (Ref.
3).
Individuals, including workers, consumers, and the general
population are exposed to NMP from industrial/commercial and consumer
sources, in different settings such as homes and workplaces, and
through multiple routes (inhalation, dermal, and vapor-through-skin).
According to data in the 2014 TRI, 386 facilities reported releases
or transfers of NMP and the top 100 facilities disposed of or released
a total of 10.2 million pounds of NMP (Ref. 6).
The use assessed by EPA that is the subject of this proposal, NMP
in paint and coating removal, represents about 9% of total use of NMP
(Ref. 3). 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 coating from
a substrate. Substrates can include objects, vehicles, architectural
features, or structures. This use is discussed in detail in Unit XVI.A.
Although the TSCA Work Plan Chemical risk assessment for NMP
focused on the chemical's use in paint and coating removal, EPA
announced in December 2016 its designation of NMP as one of the ten
chemical substances that will undergo risk evaluation pursuant to TSCA
section 6(b)(2)(A) (81 FR 91927). The Agency is proceeding with this
proposed rule addressing NMP 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 NMP while preparing
to conduct a risk evaluation of remaining NMP conditions of use under
TSCA section 6(b).
C. What are the potential health effects of NMP?
NMP is a developmental toxicant (Ref. 3). A broad set of relevant
studies including animal bioassays in rats, mice, and rabbits show that
maternal NMP exposure is associated with dose-dependent adverse
developmental impacts on the fetus (including body weight reductions
and fetal death). Developmental toxicity is the most sensitive
endpoint. Other adverse impacts resulting from NMP exposure include
effects on maternal body weight; alterations in blood cell counts;
liver, kidney, splenic, thymus, and testicular effects; and
neurotoxicity.
Nearly every study that evaluated developmental toxicity of NMP
exposure identified some type of adverse effect depending on the route
of exposure and the internal dose achieved. Moreover, a review of
effect levels reveals that these effects are observed within a
comparable dose range when administered doses are converted to internal
doses for a series of gestational exposure studies in rats. The NOAELs
for these comparable developmental studies typically ranged from 100 to
200 mg/kg/day for oral exposure, 237 mg/kg/day for dermal exposure, and
479 to 612 mg/m\3\ for inhalation exposure. EPA applied a
physiologically-based pharmacokinetic model to derive internal doses
for these exposure scenarios to compare across routes and aggregate
exposures. Specifically, EPA identified a number of biologically
relevant, consistent, and sensitive effects, representing a continuum
of reproductive and developmental effects for consideration in
assessing human health risks, including decreased fetal and postnatal
body weight, delayed ossification, skeletal malformations, and
increased fetal and postnatal mortality. EPA identified a point of
departure for decreased fetal body weight based on the average blood
concentration of 411 mg/L. Studies have shown acute effects of NMP
exposure to include fetal mortality and indications of fetal
resorptions in rodents and a point of departure based on maximum blood
concentration of 216 mg/L. Fetal and postnatal mortality have also been
observed in oral and dermal studies (Ref. 3).
Chronic effects of NMP exposure include fetal body weight
decreases. These effects were consistent among multiple studies with
different dosing regimens and across exposure routes. Reduced fetal
body weight is a sensitive endpoint that is considered a marker for
fetal growth restriction, which is often assumed to be representative
of chronic exposures. Decreases in fetal and postnatal body weights
occur at similar dose levels (Ref. 3).
There is one case report of the fetus of a pregnant woman dying in
utero at week 31 of pregnancy. The worker was exposed throughout
pregnancy to NMP by inhalation and dermal exposure, but the exposure
levels were unknown. The worker's tasks involved other chemicals,
including acetone and methanol. During week 16 of the pregnancy, the
worker cleaned up a spill of NMP using latex gloves that dissolved in
the NMP. She was ill for the next 4 days and experienced malaise,
headache, nausea and vomiting. While this study provides some evidence
that NMP may be fetotoxic, the lack of quantitative exposure data
precluded its use in the TSCA Work Plan Chemical Risk Assessment for
NMP (Ref. 3).
Chronic effects of NMP exposure include systemic effects following
[[Page 7499]]
maternal exposure, which include body weight reductions, alterations in
clinical chemistry and blood cell counts, liver and kidney toxicity,
neurotoxicity and thymic atrophy, with highly variable dose levels
where no observed adverse effects occurred (Ref. 3).
An additional effect of chronic NMP exposure is reproductive
toxicity, though these findings are significantly less frequent or
consistent than the occurrence of developmental effects. When observed,
reproductive effects were variable in occurrence and dose effect range.
Several rat studies identified some type of testicular effect,
including testicular lesions, atrophy or smaller testes. Similarly, a
small number of rat studies noted some effects related to developmental
neurotoxicity in postnatal development and behavior following maternal
exposure (Ref. 3).
In addition to developmental toxicity, exposure to NMP presents
other acute and chronic toxicity concerns. Acute effects include skin,
eye, and possible respiratory irritation. Human volunteer chamber
studies revealed some discomfort during exposure. Prolonged exposures
to neat (i.e., pure) NMP increases the permeability of the skin (Ref.
3).
D. What are the environmental impacts of NMP?
Section 6(c) of TSCA requires that EPA state the effects of NMP on
the environment and the magnitude of the exposure of the environment to
NMP. 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 NMP and are sufficient to support this proposed
action.
1. Environmental effects and impacts. Ecotoxicity studies for NMP
have been conducted in fish, aquatic invertebrates, aquatic plants and
birds. There were no acceptable studies identified for sediment or soil
dwelling organisms. Based on available data in the NMP risk assessment,
EPA concluded that NMP has low acute and chronic toxicity to aquatic
organisms (including plants) and birds (Ref. 3). Based on NMP's low
persistence, low bioaccumulation, and low hazard for environmental
toxicity, the magnitude of potential environmental impacts on
ecological receptors are judged to be low for the environmental
releases associated with the use of NMP in paint and coating removal.
2. What is the global warming potential of NMP? Global warming
potential (GWP) measures the potency of a greenhouse gas over a
specific period of time, relative to carbon dioxide, which has a GWP of
1 regardless of the time period used. No GWP has been developed for NMP
because of its very short atmospheric lifetime. Based on its very short
half-life, its GWP is expected to be very low (Ref. 3).
3. What is the ozone depletion potential of NMP? NMP is not an
ozone-depleting substance and is listed as acceptable under the
Significant New Alternatives Policy (SNAP) program for degreasing and
aerosols (Ref. 9).
4. Is NMP a volatile organic compound (VOC)? NMP is not 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.
5. Does NMP persist in the environment and bioaccumulate? NMP is
not persistent or bioaccumulative. Biodegradation studies have
consistently shown NMP to be readily biodegradable. Based on its vapor
pressure, NMP released to the atmosphere is expected to exist solely in
the vapor-phase. Vapor-phase NMP is degraded in air by reaction with
photochemically-produced hydroxyl radicals. The half-life of this
reaction is approximately 5.8 hours, assuming a hydroxyl radical
concentration of 1.5 x 10\6\ hydroxyl radicals/cm\3\ air over a 12-hr
day. NMP in the atmosphere can be expected to dissolve into water
droplets, where it will be removed by condensation or further reactions
with hydroxyl radicals (Ref. 3).
When released to water, NMP is not expected to adsorb to suspended
solids or sediment in the water column based upon its Koc value. Based
on its low soil organic carbon partitioning coefficient (log Koc =
0.9), NMP is expected to possess high mobility in soil; releases of NMP
to soil may volatilize from soil surfaces or migrate through soil and
contaminate groundwater (Ref. 3).
EPA was not able to locate measured bioconcentration studies for
NMP; however, the estimated bioaccumulation factor of 0.9 and estimated
bioconcentration factor of 3.16 suggest that bioaccumulation and
bioconcentration in aquatic organisms is low. Based on the available
environmental fate data, NMP is expected to have low bioaccumulation
potential and low persistence (Ref. 3).
XIII. Regulatory Actions Pertaining to NMP
This section summarizes current state, federal, and international
regulations and restrictions on NMP, with a focus on its use in paint
and coating removal. None of these actions imposes requirements to the
extent necessary so that NMP does not present the unreasonable risk
described in this proposed rule.
A. Federal Actions Pertaining to NMP
While many of the statutes that EPA is charged with administering
provide statutory authority to address specific sources and routes of
NMP exposure, none of these can address the serious human health risks
from NMP exposure that EPA is proposing to address under TSCA section
6(a).
NMP is listed on the Toxics Release Inventory (TRI) and is
therefore subject to reporting pursuant to Section 313 of the Emergency
Planning and Community Right-to-Know Act (EPCRA) (Ref. 6).
NMP is on The Clean Air Act (CAA) Section 111, Standards
of Performance for New Stationary Sources of Air Pollutants--Equipment
Leaks Chemical List (40 CFR 68.130)
NMP is currently approved for use by EPA as a solvent and
co-solvent inert ingredient in pesticide formulations for both food and
non-food uses and is exempt from the requirements of a tolerance limit
(Ref. 74).
In 2013, the Consumer Product Safety Commission issued a fact sheet
warning the public about hazards of paint sand coating removal
products, including those containing NMP, and included recommendations
for PPE when using products containing this chemical (Ref. 62).
B. State Actions Pertaining to NMP
Several states have taken actions to reduce or make the public
aware of risks from NMP. California has set worker protection
regulations that require workers to wear gloves when using NMP, and
workplace to meet a permissible exposure limit of 1 ppm as an eight-
hour time-weighted average (TWA) (Ref. 3). Additionally, NMP is listed
as an informational candidate on California's Safer Consumer Products
regulations candidate list of chemicals that exhibit a hazard trait and
are on an authoritative list and is also listed on California's
Proposition 65 list of chemicals known to cause cancer or birth defects
or other reproductive harm (Ref. 3).
In Washington, NMP is listed as a chemical of high concern under
the Children's Safe Product Act (Ref. 3). Minnesota classifies NMP as a
chemical of high concern and several other states have placed NMP on
similar chemical listings. Additional states have
[[Page 7500]]
recognized NMP as an air pollutant (Ref. 3).
C. International Actions Pertaining to NMP
NMP is currently on the candidate list of substances of very high
concern for authorization in the European Union. In August 2013, the
Dutch National Institute for Public Health and the Environment
submitted a proposal for the restriction of NMP to the European
Chemicals Agency under the Registration, Evaluation, Authorisation and
Restriction regulation. The Risk Assessment Committee modified the
restriction proposal and the combined opinion will be sent to the
European Commission for final decision. The Risk Assessment Committee
recommended using long-term exposure Derived No Effect Levels for
pregnant workers (the most sensitive population) for both inhalation
and dermal exposure (Ref. 3).
Other countries have also recognized the risks of NMP. When Canada
conducted a categorization of the Domestic Substances List for its
Chemicals Management Plan in 2006, NMP met Canada's human health
categorization criteria. NMP has been the subject of a Tier II health
risk assessment in Australia under that country's Inventory Multi-
tiered Assessment and Prioritisation. It is currently subject to
labeling and related requirements based on concern for skin, eye and
respiratory irritation and for reproductive toxicity. These government
assessments consider NMP to be of low environmental concern (Ref. 3).
Australia concluded that further risk management is required and
additional assessment (Tier III) is needed to determine if current
exposure controls are adequate to protect workers and the public when
NMP is used in domestic products (Ref. 3).
XIV. NMP Risk Assessment and Outreach
In 2013, EPA identified NMP in paint and coating removal as a
priority for risk assessment under the TSCA Work Plan. This unit
describes the development of the NMP 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
NMP in paint and coating removal can be found in Units XVI.B.1. and
XVI.D.
A. TSCA Work Plan for Chemical Assessments
Using the TSCA Work Plan chemical prioritization criteria,
discussed in Unit IV.A., NMP ranked high for health hazards and
exposure potential and was included on the initial list of TSCA Work
Plan chemicals for assessment. NMP appeared in the 2012 TSCA Work Plan
for Chemical Assessments and in the 2014 update of the TSCA Work Plan
for Chemical Assessments.
B. NMP Risk Assessment
EPA finalized a TSCA Work Plan Chemical Risk Assessment for NMP
(NMP risk assessment) in 2015, following the 2013 peer review of the
2012 draft NMP risk assessment. All documents from the 2013 peer review
of the draft NMP risk assessment are available in EPA Docket Number
EPA-HQ-OPPT-2012-0725. The completed risk assessment is included in
that docket.
The NMP risk assessment evaluated health risks to consumers,
workers, and bystanders from dermal and inhalation exposures to NMP
when used in paint and coating removal (Ref. 3). EPA assumes workers
and consumers would be adults of both sexes 16 years and older,
including pregnant women. EPA assumes bystanders in residential
settings would be individuals of any age group (e.g., children, adults,
and the elderly) nearby during product application. During scoping and
problem formulation for the risk assessment, EPA focused on
occupational and consumer paint and coating removal because of high NMP
content in products and potential high exposure to workers and
consumers. EPA selected these uses for the NMP risk assessment because
they were expected to involve frequent or routine use of NMP in high
concentrations and/or have high potential for human exposure (Ref. 3).
However, this does not mean that EPA determined that other uses not
included in the NMP risk assessment present low risk.
The NMP risk assessment characterized human health effects
associated with paint removal with NMP. Based on the physical-chemical
properties of NMP and the paint stripping use scenarios described in
the assessment, EPA views dermal exposure as the predominant route of
exposure to NMP during paint removal, including absorption of vapor-
through-skin.
The NMP risk assessment identified developmental risks of concern
following acute (short-term) and chronic (repeated) exposures for
workers conducting paint removal with NMP. Specifically, these
developmental effects include increased fetal resorptions (fetal death)
from acute exposures and decreased fetal body weight from chronic
exposures (Ref. 3). EPA identified acute risks of concern for consumers
using NMP for paint and coating removal in the more complete array of
scenarios described in the supplemental analyses, which used the same
modeling methods as the risk assessment (Refs. 75 and 76).
Margins of exposure (MOEs) were used in the risk assessment and
supplemental analyses to estimate non-cancer risks for acute and
chronic exposures. For an explanation of MOEs, see Unit IV.B. For NMP,
EPA identified acute or chronic non-cancer risks of concern if the MOE
estimates were less than the benchmark MOE of 30 (Ref. 3). The health
endpoint used for the benchmark MOE for acute exposure to NMP is fetal
death; the health endpoint used for the benchmark MOE for chronic
exposure to NMP is decreased infant birth weight. These are the most
sensitive adverse health effects from exposure to NMP.
The NMP risk assessment and supplemental analyses estimated acute
risks of fetal death for consumers from the use of paint and coating
removers containing NMP, and acute and chronic non-cancer risks of
decreased infant birth weight for workers from the use of paint and
coating removers containing NMP. Exposure scenarios with MOEs below the
benchmark MOE present risks of concern. Typically, non-cancer adverse
effects are more likely to result from exposure scenarios with MOEs
multiple orders of magnitude below the benchmark MOE. For non-cancer
effects, EPA estimated exposures that are significantly larger than the
point of departure (Ref. 3). Specifically, the assessment identified
risks of fetal death from acute exposures of:
Four or fewer hours per day, when gloves were not used.
Greater than 4 hours per day, and risks were not mitigated
by personal protective equipment such as respirators or gloves.
The assessment identified risks of decreased infant birth weight
from chronic (repeated) exposures of:
Four or fewer hours per day, when gloves were not used.
Greater than 4 hours per day, and risks were not mitigated
by personal protective equipment such as respirators or gloves.
Over the course of a work-week (5 days)
Given the risks identified in the NMP risk assessment, the agency
undertook further analysis to consider whether that use of NMP in paint
and coating removal poses an unreasonable risk.
C. Supplemental Analysis Consistent With the NMP Risk Assessment
Following the NMP risk assessment, EPA conducted supplemental
analyses
[[Page 7501]]
to inform risk management and to expand on the consumer exposure
scenarios. These analyses are consistent with the scope of the NMP risk
assessment and were based on the peer-reviewed methodology used in the
NMP risk assessment. They included identification of baseline and
central tendency exposure scenarios, impacts of reduced NMP content in
paint removers, addition of local exhaust ventilation (LEV), use of
personally protective equipment (PPE), and methods of monitoring to
ascertain workplace exposures. The results of EPA's analyses are
available in this rulemaking docket (Refs. 37, 75, and 76). Prior to
promulgation of the final rule, EPA will peer review the
``Recommendation for an Existing Chemical Exposure Limit (ECEL) for
Occupational Use of NMP and Workplace Air Monitoring Methods for NMP,''
``Respirator and Glove Specifications for Workers and Consumers Exposed
to N-methylpyrrolidone (NMP) in Paint and Coating Removal and Estimated
Fractions of Worker Population Vulnerable to the Acute Health Effect,''
and ``Supplemental Consumer Exposure and Risk Estimation Technical
Report for NMP in Paint and Coating Removal'' (Refs. 37, 75, and 76).
D. Outreach
In addition to the consultations described in Unit XXIII., EPA
initiated discussions with experts on and users of paint removers (Ref.
22). For more information on these discussions, see Unit IV.D.
XV. Regulatory Approach for NMP 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 EPA'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.
The 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 unreasonable risk so that
it no longer presents such risk. To do so, EPA initially analyzed
whether the regulatory options could reduce risks to levels below those
of concern, based on EPA's technical analysis of exposure scenarios.
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, EPA 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 impacted by environmental justice or children's
health concerns.
B. TSCA Section 6(c)(2) Considerations
As noted previously, 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, NMP) and the magnitude of human exposure to NMP;
Environmental effects of NMP and the magnitude of exposure
of the environment to NMP;
Benefits of NMP 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 health effects and magnitude of exposure to NMP
can be found in Units XIV.B., XVI.B. and XVI.C., which discuss the NMP
risk assessment and EPA's regulatory assessment of the use of NMP in
paint and coating removal. A discussion of the environmental effects of
NMP is in Unit XII.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). The regulatory options and consideration of TSCA section
6(c)(2) factors are discussed in more detail in Unit V for methylene
chloride in paint and coating removal and in Unit XV. for NMP in paint
and coating removal.
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., residual risk
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
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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 XVI.C. and XVII.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 the 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 XVI.E. and XVII.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 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 NMP in paint and coating removal are discussed in
Unit XVI.A., along with the availability of alternatives. The dates
that the proposed restrictions would take effect are discussed in Unit
XX. The availability of alternatives to methylene chloride in paint and
coating removal on those dates is discussed in Unit XVI.D.
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 NMP is likely to increase
demand for alternatives, which EPA expects would result in the
development of new alternatives. See 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
NMP or limit the amount of NMP which may be manufactured, processed or
distributed in commerce is not applicable because EPA is not proposing
to ban or limit the manufacture, processing or distribution in commerce
of NMP for uses other than paint and coating removal.
In addition, EPA reasoned 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 NMP disposal.
Another option EPA evaluated would be to only require warning
labels and instructions on paint and coating removal products
containing NMP, pursuant to section 6(a)(3) (Ref. 30). EPA reasoned
that warning labels and instructions alone could not mitigate the risks
as necessary so that NMP no longer presents an unreasonable risk
(either to users in the general population or to users who are women of
childbearing age). For a further discussion of why EPA believes that
labeling alone will not effectively mitigate the unreasonable risks,
see Unit V.C. EPA's general observations about labeling, described in
that unit, are also applicable in the case of NMP. Specifically
regarding NMP, effective personal protection resulting in risk
reduction would require not only the appropriate donning and doffing of
specialized gloves that are not easily available to consumers, but also
identification of which type of glove is protective against particular
formulations of paint and coating removal products containing NMP (Ref.
75). Any labeling aiming to reduce risks to consumer or commercial
users of these products would need to sufficiently and clearly explain
this, and would still leave the user with the problem of obtaining and
properly using the appropriate gloves and (in the case of commercial
users or consumers using the product for several days at a time) the
appropriate respirator. With respect to consumer risks in particular, a
label on a product that is easily available to consumers, that directs
the user to obtain and use safety equipment that is not easily
available to consumers, is especially unlikely to be correctly
followed.
A 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
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 NMP in paint and coating removal.
However, unlike the process for training and certification of
commercial workers required under the Lead Renovation, Repair, and
Paint Rule, effective risk reduction from commercial use of NMP 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 Renovation, Repair, and Paint 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 NMP for workers so
that those risks are no longer unreasonable.
XVI. Regulatory Assessment of NMP in Paint and Coating Removal
This unit describes the current use of NMP 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. NMP in Paint and Coating Removal
As described previously in Units I.A. and VI.B., paint and coating
removal, also referred to as paint stripping, is the process of
removing paint or other coatings from a surface of a substrate, such as
an object or structure (Ref. 3). More information on specific
techniques for paint removal in each industry and by consumers are in
the NMP risk assessment and supplemental materials (Refs. 3, 75, and
76).
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
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situations, such as bathtub refinishing (Refs. 11, 32, and 33). There
are no restrictions on using products intended for one specific type of
paint removal project in a different setting. Additionally, consumers
face no restrictions when using products intended for or marketed to
professional users.
EPA has identified 64 different products for paint and coating
removal that contain NMP, formulated by 21 different firms. This is
approximately 59% of the total number of paint and coating removal
products EPA identified (109 products) (Ref. 34). Though the number of
workers and consumers exposed to NMP during paint and coating removal
is uncertain, EPA has several estimates based on industry data. As
described in Unit VI.B., commercial uses 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. As described in more detail in the Economic Analysis, EPA
estimates that 30,300 workers annually are exposed to NMP during paint
and coating removal activities (Ref. 4).
Consumer use of NMP in paint and coating removal is similar to
commercial use, but occurs in consumer settings, such as homes,
workshops, basements, garages, and outdoors. Paint and coating removal
products containing NMP 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.
When consumers interested in DIY paint and coating removal choose
to use chemical paint removers (Ref. 77), they frequently receive
advice to use products that contain NMP, without any reference to the
risks presented by NMP or even solvents in general (Refs. 78 and 79).
Manufacturers and retailers of paint and coating removal products
containing NMP frequently sell them to consumers in small containers
with marketing language or labeling that state they are biodegradable,
`plant-based', or contain `no harsh fumes' and implies they are `green'
or `safe' (Ref. 35). Products containing NMP are not required to be
labeled with that information or any information about personal
protection or risk reduction. These products are frequently sold at
home improvement retailers or automotive supply stores that sell
products to consumers as well as professional users (Ref. 35).
Additionally, due to the wide availability of products available on the
Internet and through various additional suppliers that serve commercial
and consumer customers, consumers are able to purchase a variety of
paint and coating removal products containing NMP. EPA estimates that
the majority of users of paint and coating removal products containing
NMP are consumers, rather than occupational users. EPA estimates that
approximately 732,000 consumers annually use paint removal products
containing NMP (Ref. 4).
B. Analysis of Regulatory Options
In this section, EPA explains how it evaluated whether the
regulatory options considered would address the unreasonable risks
presented by the use of NMP in paint and coating removal. First, EPA
characterizes the unreasonable risks associated with the current use of
NMP in paint and coating removal. Then, EPA describes its initial
analysis of which regulatory options have the potential to achieve non-
cancer benchmarks. 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
NMP risk assessment and additional supplemental analyses identified
acute and chronic risks for consumers and commercial users of paint and
coating removal products containing NMP following exposure through
dermal contact, inhalation, and vapor-through-skin (Refs. 3, 75, and
76). EPA did not find risks for occupational or residential bystanders
(individuals not using the paint and coating remover, but near someone
who is). EPA estimates, having refined the numbers since the risk
assessment that, annually, there are approximately 30,300 workers at
4,300 commercial operations conducting paint and coating removal with
NMP, and approximately 732,000 consumers who use paint and coating
removal products containing NMP each year (Ref. 4).
b. Impacts on minority and other populations. While all consumers
and workers using paint and coating removal products containing NMP
would benefit from risk reduction, some populations are currently at
disproportionate risk for the health effects associated with NMP in
paint and coating removal. These are the same populations at
disproportionate risk for the health effects associated with methylene
chloride in paint and coating removal, and are described in Unit
VI.C.1.b.
c. Impacts on children. EPA has concerns for effects on the
developing fetus from acute and chronic worker and consumer maternal
exposures to NMP. The risk estimates focus on the most susceptible life
stages, which for NMP are women of childbearing age and their
developing fetus. However, because women may not know that they are
pregnant (Refs. 80 and 81) and short-term exposure to NMP may adversely
impact fetal development during a single day or single week of
exposure, the life stages of concern for risk assessment include all
women of childbearing age (i.e., women between the ages of 16 and 49
years) and the developing fetus. The impacts to children derive from
the pre-natal or maternal exposure; these impacts include decreased
fetal weight, decreased birth (post-natal) weight, and fetal death.
Details on the impacts of these health effects are described in Unit
XVI.C.
EPA assumed that consumer and commercial users would generally be
adults of both sexes (16 years old and older, including women of
childbearing age), although exposures by teenagers and even younger
individuals may be possible in consumer settings. However, risk
estimates focused on the most susceptible life stage, which are
pregnant women and their developing fetus, because developmental
toxicity is one of the most sensitive health effects associated with
NMP exposure (Ref. 3).
d. Exposures for this use. Exposures assessed for this in the risk
assessment and supplemental analyses use include acute and chronic (or
repeat-dose) exposures by commercial workers and acute exposures by
consumers engaging in paint and coating removal with NMP, as described
in the NMP risk assessment and additional analyses (Refs. 3 and 76).
The exposure pathways of interest included dermal contact, vapor-
through-skin, and inhalation. Acute scenarios assumed one day, or up to
eight hours, of exposure; chronic, or repeat-dose, scenarios assumed
five days of exposure per week, or one work week, with up to eight
hours per day of exposure (Refs. 3 and 76).
For exposures in commercial settings, EPA assessed exposure
scenarios under which the worker was presumed to work on either an
indoor project (such as work by professional contractors, furniture
stripping and other settings) or an outdoor or semi-enclosed space
(such as graffiti removal on the exterior of a building, outdoor
escalator, or elevator).
In the NMP risk assessment, EPA developed six occupational user
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exposure scenarios for assessment. The following factors were
considered in developing the exposure scenarios (Ref. 3):
The weight fraction of NMP in the paint and coating
removal product;
Skin surface area of the worker in contact with the paint
removal product; and
Duration of contact (in hours) with the paint removal
product.
Within each of the six workplace scenarios, EPA evaluated five
permutations, by modifying the parameters of the scenario to include
different combinations of personal protective equipment (PPE). These
permutations were (1) respirator with assigned protection factor (APF)
of 10, and gloves; (2) respirator APF 10 only; (3) gloves only; (4)
neither respirator nor gloves; and (5) not directly using the product
(nearby worker) (Ref. 3).
EPA used air concentration data and estimates found in literature
sources to serve as inhalation exposure concentration inputs to the
physiologically-based pharmacokinetic modeling for occupational
exposures to NMP. This modeling was used to derive internal dose
estimates for acute and chronic occupational exposures, and predicted
absorption of liquid or vapor by the individual in the scenario when
using the paint and coating removal product containing NMP (Ref. 3).
For consumer exposures, EPA assessed exposure scenarios under which
the individual was presumed to work on one of several types of paint
and coating removal projects (table and chairs, chest of drawers, or
bathtub), with inputs reflecting that consumers do not reliably use
personal protective equipment (effective gloves) or have access to
engineering controls (e.g., ventilation fan). In each scenario, the
consumer would be exposed via inhalation, dermal contact, and vapor-
through-skin (Ref. 3).
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. 3):
The type of application (i.e., brush-on or spray-on),
weight fraction of NMP 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 NMP 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 NMP emissions.
In the absence of representative air monitoring data for consumers
using paint and coating removal products containing NMP, EPA used the
Multi-Chamber Concentration and Exposure Model to estimate consumer
inhalation exposure concentrations. The predicted air concentrations
from the exposure modeling for users and non-users were inputs to the
physiologically-based pharmacokinetic modeling software and used to
define consumers' moment-by-moment air concentration inhaled and in
contact with unobstructed skin. The parameters and data sources for the
model are described in the NMP risk assessment (Ref. 3).
EPA's estimates of the exposures individuals experienced during the
acute and chronic scenarios of commercial or consumer use of paint and
coating removal products containing NMP were used to assess the risks
of these uses of NMP. The full exposure estimates and risk findings are
described in the NMP risk assessment; risk findings are also summarized
in Unit XVI.B.1.a.
In addition to estimating likely exposures under current use
patterns, for both commercial and consumer users, EPA assessed a number
of exposure scenarios associated with risk reduction options in order
to identify variations in NMP exposure. All variations in the scenarios
were 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
were varied between scenarios included material substitution, duration
of use, engineering controls, and use of PPE, as well as combinations
of these options (Refs. 37, 75, and 76), as follows:
The material substitution scenarios involved reducing the
concentration of NMP in the paint and coating removal product, with
concentrations varying from 5, 10, 25, 30, 35, 40, 62.5 and 100% by
weight in the product.
The duration of use scenarios involved, for consumers,
variations in the type of activity during which paint removal would be
conducted (for example, 7 hours of exposure to NMP when removing paint
from a table and 8 chairs; 0.5 hours of exposure to NMP when removing
paint from a coffee table). For commercial users, duration of exposure
to NMP in paint and coating removers was assessed as job time during a
work day (1 to 8 hours).
Under the PPE risk reduction option exposure scenarios,
EPA evaluated consumers wearing specialized gloves, and workers wearing
specialized gloves and/or respirators with APF 10.
For the engineering controls risk reduction option
exposure scenarios, EPA evaluated using LEV to improve ventilation near
the activity of workers in furniture refinishing operations, with an
assumed 90% reduction in exposure levels.
Additionally, EPA evaluated combinations of the options. For
consumers, this included material substitution, duration of exposure,
and PPE; for workers, this included material substitution, duration of
exposure, PPE, and LEV. Engineering controls are not assumed to be
practical for consumers as a method of exposure reduction. Overall, EPA
evaluated dozens of distinct exposure scenarios for both consumer and
commercial paint and coating removal with NMP.
e. Specific risks for this use. The assessment of acute risks used
developmental toxicity data to evaluate the acute risks for paint and
coating removal with NMP. EPA based its assessment of acute risks on
the endpoint most protective of health (i.e., fetal death (Ref. 3)),
representing the most sensitive human life stage (i.e., women of
childbearing age (greater than 16 years) and the fetus). Because fetal
effects were selected as key endpoints, risks were calculated for
pregnant women and women of childbearing age who may become pregnant.
As described in the risk assessment, exposures that do not result in
risks of concern for these particular lifestages are also found to be
protective of children and adult males. A risk of concern was
identified if the MOE estimate was less than the benchmark MOE of 30
(Ref. 3).
In the risk assessment and supplemental analyses, EPA evaluated
risks for fetal death from dermal contact, inhalation, and vapor-
through-skin for all consumer, occupational, and bystander exposure
scenarios of paint and coating removal with NMP. No risks were
identified for occupational or residential bystanders. Acute risks of
fetal death were identified for the
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consumer and commercial users of NMP for paint and coating removal in
several, although not all, scenarios. To identify what, if any, risks
may be present for consumers in different scenarios, EPA conducted
additional analyses consistent with the risk assessment to provide an
expanded understanding of consumer exposures (Ref. 76). Additionally,
it appears that consumers could engage in patterns of use comparable to
worker exposures that present risk; for example, any consumers engaging
in paint and coating removal with NMP for longer than four hours in one
day could be subject to the acute occupational risks identified (Ref.
3).
For commercial users, the occupational scenarios in which acute
risks were identified included four hours of paint removal in one day
with no gloves, with or without a respirator, indoors or outdoors,
assuming mid-range of the exposure parameters described earlier, such
as concentration of NMP in the product (MOEs range from 12 to 15); and
four hours of paint removal in one day with or without a respirator and
gloves, indoors or outdoors, assuming the higher exposure parameters
described earlier (MOEs range from 0.7 to 11.8) (Ref. 3). These risks
are present whether the worker is indoors or outdoors, and may be
present even in the presence of PPE or ventilation, depending on the
duration of use and the concentration of NMP in the product. Therefore,
EPA's proposed determination is that acute NMP exposures during paint
and coating removal present unreasonable risks.
EPA also assessed risks of chronic exposure to NMP by commercial
users, with a short-term chronic exposure that can be defined as a
repeat-dose scenario in which the individual is exposed over the course
of a work week, rather than over a lifetime. This chronic assessment
used decreased fetal body weight as the critical endpoint. EPA assessed
risks for decreased birth weight for occupational and bystander
exposure scenarios of paint and coating removal with NMP. In the risk
assessment, a risk of concern was identified if the MOE estimate was
less than the benchmark MOE of 30 for decreased birth weight (Ref. 3).
Risk of decreased birth weight was identified for commercial users
of NMP for paint and coating removal in several scenarios, including
four hours of paint removal during each day in a work week without
gloves, with or without a respirator, indoors or outdoors, assuming the
mid-range of the exposure parameters described earlier, such as
concentration of NMP in the product (MOEs range from 5.4 to 6.1); and
eight hours of paint removal during each day in a work week, with or
without a respirator or gloves, indoors or outdoors, assuming the
higher exposure parameters described earlier (MOEs range from 0.1 to
3.2) (Ref. 3). Though no risks were identified for occupational
bystanders, for workers, these risks are present whether the worker is
indoors or outdoors, and may be present even if PPE or ventilation is
used, depending on the duration of use and the concentration of NMP in
the product (Ref. 3). In some scenarios, this equates to estimated
exposures that are more than 10 times greater than those that would
produce the benchmark MOE for this endpoint, which assesses risks for
fetal death and decreased birth weight. Therefore, EPA's proposed
determination is that chronic NMP exposures during paint and coating
removal also present unreasonable risks.
The SBAR Panel convened in support of this action heard from
several SERs who expressed concerns about the underlying NMP 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 NMP 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 NMP in paint and coating removal were
unreasonable, EPA evaluated how regulatory options under section 6(a)
might reduce the risks so that they are 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 NMP in a product or advising the use of
specialized gloves or respirators individually could not achieve the
target MOE benchmarks for acute exposures (Ref. 76). Similarly, the
results of EPA's evaluation indicate that regulatory options for
occupational exposures such as reducing the concentration of NMP 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 for non-cancer endpoints for acute
and chronic exposures (Refs. 37 and 75). The results also demonstrate
that all risk reduction options meeting the benchmark MOEs for NMP in
paint and coating removal require the use of specialized gloves,
whether used alone or in conjunction with additional levels of
respiratory protection such as a respirator of APF 10 or the use of an
air exposure limit, even when the concentration of NMP in a product was
limited to 25 percent. Therefore, EPA found setting a maximum
concentration of NMP in products under TSCA section 6(a)(2) alone would
not reduce exposures to levels at which risks would be at or below the
risk benchmarks. Further, EPA's analysis found that even with
specialized gloves and a respirator, workers would be at risk of NMP
exposure if they used products with more than 25 percent NMP.
Additional exposure level estimates for various scenarios are available
in the supplemental analyses, which also document options that did not
meet the risk benchmarks and which do not, for purposes of this
proposal, address the identified unreasonable risks (Refs. 37, 75, and
76).
3. Assessment of whether regulatory options address the identified
unreasonable risks to the extent necessary so that NMP 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
NMP in paint and coating removal, which are reflected in EPA's
supporting analysis (Ref. 30). In assessing these options, EPA
considered a wide range of exposure scenarios (Refs. 75 and 76). These
include both baseline and risk reduction scenarios involving varying
factors such as concentration of NMP in paint and coating removal
products, LEV use, respirator and glove use, and duration of use. 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 the use of NMP in paint and coating removal as a
whole rather than as separate consumer and commercial uses. As
described earlier in Unit XVI.A., paint and coating removal products
containing NMP 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.
The Agency examined two main alternative approaches to addressing
the unreasonable risk from NMP in paint and coating removal under
current conditions of use by consumers and commercial users. These two
approaches are the supply chain approach (and its two primary
variations) and the reformulation, labeling, and PPE approach. These
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regulatory alternatives are the options that have the potential to
address the unreasonable risks presented by NMP when used for paint and
coating removal by consumers, commercial users, or for both. The two
options and their variations are described below.
(a) The first co-proposed approach (option 1) is a supply-chain
approach, which would include prohibiting the manufacturing,
processing, and distribution in commerce of NMP for paint and coating
removal under TSCA section 6(a)(2) except for certain uses critical to
national security; prohibiting the commercial use of NMP in paint and
coating removal under TSCA section 6(a)(5) except for certain uses
critical to national security; requiring that all paint and coating
removers containing NMP be distributed in containers with volumes no
less than 5 gallons under TSCA section 6(a)(2); requiring downstream
notification when distributing NMP for other uses under TSCA section
6(a)(3); and limited recordkeeping under TSCA section 6(a)(4);
(b) Variations on such a supply-chain approach, such as just
prohibiting the manufacturing, processing, and distribution in commerce
of NMP for paint and coating removal under TSCA section 6(a)(2) for
consumer and commercial use or just prohibiting the commercial use of
NMP for paint and coating removal under TSCA section 6(a)(5);
(c) Additional variations on such a supply-chain approach, such as
prohibiting the manufacturing, processing, and distribution in commerce
of NMP for paint and coating removal under TSCA section 6(a)(2) for
consumer and commercial use and requiring downstream notification
(e.g., via SDS) when distributing NMP for other uses under TSCA section
6(a)(3); and
(d) The second co-proposed approach (option 2), a reformulation,
PPE, and labeling approach, which would require (1) product
reformulation to limit the concentration of NMP in paint and coating
removal products under section 6(a)(2); (2) testing of product
formulations to identify specialized gloves that provide protection for
users and relevant recordkeeping under section 6(a)(4); (3) relabeling
of products intended for consumer use to provide additional information
to consumers under section 6(a)(3); (4) an occupational dermal and
respiratory protection program for commercial use of NMP in paint and
coating removal, including a requirement for hazard communication,
specialized gloves and an air exposure limit or respirator under
section 6(a)(5); (5) a prohibition on use of NMP above a concentration
of 35 percent for commercial paint and coating removal under 6(a)(5);
(6) downstream notification when distributing NMP for other uses under
TSCA section 6(a)(3); and (7) limited recordkeeping under TSCA section
6(a)(4). Under this co-proposed approach, EPA is not proposing an
exemption for coating removal uses identified as critical to 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.
A discussion of the regulatory options that could reach the risk
benchmarks for consumer use, commercial use, or both is in this unit,
along with EPA's evaluation of how well those regulatory options would
address the unreasonable risks EPA has identified. EPA requests comment
on the two co-proposed regulatory options addressing the use of NMP in
paint and coating removal, particularly with regard to the advantages
and disadvantages of the different approaches, their potential
associated benefits, and whether such approaches would be consistent
with EPA's obligation under TSCA to address risks identified as
unreasonable.
a. First co-proposed approach: Supply-chain (option 1). The
proposed regulatory approach for NMP in consumer and commercial paint
and coating removal would prohibit the manufacturing, processing, and
distribution in commerce of NMP for consumer and commercial paint and
coating removal under TSCA section 6(a)(2), except for certain uses
critical to national security; would prohibit the commercial use of NMP
for paint and coating removal under TSCA section 6(a)(5), except for
certain uses critical to national security; would require any remaining
paint and coating removal products containing NMP to be distributed in
containers with a volume no less than 5 gallons, under TSCA section
6(a)(2); would require manufacturers, processors, and distributors of
NMP 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 earlier, a risk of concern was identified if the MOE
estimate was less than the benchmark MOE of 30. As described in Unit
XVI.B.1., the baseline risks for workers and consumers from paint and
coating removal with NMP were identified as ranging from two to 10
times below the benchmark MOEs of 30 for fetal death (the acute health
impact) or low birth weight (the chronic health impact). Under this
proposed option, exposures to NMP during paint and coating removal
would be eliminated for consumers and workers. As a result, acute and
chronic risks would be eliminated.
The first co-proposed approach would ensure that workers and
consumers from the general population (as well as workers and consumers
who are women of childbearing age) are no longer exposed to
unreasonable risks from NMP exposure during paint and coating removal.
Prohibiting the manufacturing, processing and distribution in commerce
of NMP for paint and coating removal would minimize the overall
availability of NMP for paint and coating removal. 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 NMP for paint and coating removal would reduce
commercial demand for NMP paint and coating removal products, reduce
the likelihood that other types of products formulated with NMP would
be used for paint and coating removal, and significantly reduce the
potential for consumer use of commercial paint and coating removal
products containing NMP. Workers would not be exposed to NMP for paint
and coating removal, except for those uses that are proposed to be
exempt because they are critical to national security. The risk to
consumers would be minimized because commercial paint and coating
removal products containing NMP would not be available outside of those
directly supplied to DOD for uses identified as critical to national
security.
The downstream notification of these restrictions ensures that
processors and distributors are aware of the manufacturing, processing,
distribution in commerce and use restrictions for NMP in paint and
coating removal, and enhances the likelihood that the risks associated
with this use of NMP 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 completely mitigates the risk to consumers and workers from
NMP in paint and coating removal.
b. Options that are variations of elements of the co-proposed
supply-chain approach (option 2). One
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variation of the proposed approach would be to prohibit manufacture,
processing, and distribution in commerce of NMP for consumer and
commercial paint removal for the uses proposed for regulation this
without the prohibition on commercial use of NMP 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 and
consumer users could obtain NMP (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 NMP 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. EPA requests comment on its
consideration of and conclusions regarding this option.
Another regulatory option that EPA considered was to prohibit only
the commercial use of NMP for paint and coating removal. This approach
would reduce 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 NMP for consumer and commercial
use, this approach would not address consumer risks as distributors of
paint and coating removal products containing NMP could continue to
distribute to consumers NMP 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, consumers would continue to be exposed far above the health
benchmarks and would not be protected from the unreasonable risks posed
by NMP. EPA requests comment on its consideration of and conclusions
regarding this option.
c. Prohibit the manufacturing, processing, and distribution in
commerce of NMP for consumer paint and coating removal under TSCA
section 6(a)(2) or prohibit the manufacturing, processing, and
distribution in commerce of NMP for consumer paint and coating removal
under TSCA section 6(a)(2) and require downstream notification when
distributing NMP for other uses under TSCA section 6(a)(3). EPA
considered prohibiting the manufacturing, processing, and distribution
in commerce of NMP only 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 NMP in paint and coating
removal. However, 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 NMP in paint
and coating removal. EPA requests comment on its consideration of and
conclusions regarding this option.
d. Second co-proposed approach: Reformulation, labeling, and PPE
approach. EPA is co-proposing two regulatory options for NMP. The
second co-proposed option would involve product reformulation, glove
testing, labeling, and worker protection. This approach has the
potential to reduce the risks presented by NMP during paint and coating
removal. EPA currently believes this potential is greater for workers
than for consumers. potential is greater for workers than for
consumers. EPA is considering this co-proposed regulatory option, and
may adopt it in the final rule; the Agency therefore solicits comment
on the option, as described below.
i. Description of second co-proposed approach. The second co-
proposed approach for NMP in commercial and consumer paint and coating
removal requires actions from commercial users and product formulators.
Under this approach, under section 6(a)(5), commercial users of NMP for
paint and coating removal would be required to establish a worker
protection program for dermal and respiratory protection, including
hazard communication, training, and requirements that workers wear
clothing covering most of the body, i.e., impervious long pants and
shirts with long sleeves, use gloves specified by product formulators
(described under formulator requirements below) and a respirator with
APF 10, with an alternative air exposure limit of 5 ppm achieved
through engineering controls or ventilation. Also under this approach,
formulators of products for either commercial or consumer use would be
required to (1) Reformulate products such that paint and coating
removal products containing NMP do not exceed a maximum of 35 percent
NMP by weight in product formulations under section 6(a)(2) (except for
product formulations destined to be used by DOD or its contractors
performing work only for DOD projects identified in Unit XVIII.); (2)
Test gloves for the product formulations being processed and
distributed in commerce to identify specialized gloves that provide
protection for users under section 6(a)(4); (3) Label products with
information for consumers about reducing risks when using the products,
including identifying which specialized gloves provide protection
against their specific formulation; and (4) Provide information for
commercial users about reducing risks when using the product, via
product labels, SDS, and other methods of hazard communication.
Variations of more than 1% in any component of a paint and coating
removal product containing NMP would be considered a separate
formulation.
Specifically, for labeling targeted to consumers under section
6(a)(3) formulators would be required to provide the following
information to consumers on product labels: A warning that irreversible
health effects such as fetal death may occur as a result of using the
product; instructions to not use the product without a new (i.e.,
replaced each time the product is used) pair of the formulation-
specific gloves identified on the label; instructions to either use the
product outdoors or to adequately ventilate the workspace by opening
windows and adding fans; instructions to not spray-apply the product;
instructions to wear clothing that covers exposed skin; and
instructions to use a respirator of APF 10, such as a NIOSH-certified
air-purifying elastomeric half-mask respirator equipped with N100,
R100, or P100 filters. The labeling requirement would also include
appropriate placement and font size for the label information.
EPA requests comments on the components of this co-proposal,
particularly on the maximum percent concentration that would be
permitted
[[Page 7508]]
in paint and coating removal products containing NMP. EPA notes that
the air exposure limit described earlier correlates with the
concentration of NMP in the product, and would necessarily change with
any corresponding change in NMP concentration (Ref. 37). EPA's
calculations for the estimated exposures from products at various
concentrations is in Ref. 75.
EPA also requests comment on the scientific and technical support
used for development of the 5 ppm air exposure limit (Ref. 37) for NMP
and the feasibility of implementing and enforcing this performance-
based approach. Additionally, EPA is requesting comment on the cost to
achieve reduced exposures in the workplace or to transition to
alternative chemicals or technologies. EPA is requesting comment on
whether this alternate option of allowing industrial use at specified
exposure levels and with appropriate personal protective equipment
should be adopted. Specifically, EPA seeks information on whether this
alternative approach would incentivize industry to eliminate NMP use in
paint and coating removal wherever technically feasible while
minimizing disruptive impacts to those processes where technically
feasible substitutes are currently unavailable. EPA also requests
comment on whether there should be a phase-in period, e.g., 3 years for
formulators to develop the new formulations of products containing NMP
at 35 percent. This would also allow users to make the transition. EPA
also requests comment on whether the 35% limit on the concentration of
NMP in the formulation is appropriate; whether EPA should specify a
higher, lower or no limit; and why. Finally, EPA requests comment on
the specific regulatory requirements for glove testing and for personal
protective equipment programs. EPA has identified two ASTM
International standards that are pertinent to glove testing, ASTM F739,
``Standard Test Method for Permeation of Liquids and Gases through
Protective Clothing Materials under Conditions of Continuous Contact,''
and ASTM F1194-99, ``Standard Guide for Documenting the Results of
Chemical Permeation Testing of Materials Used in Protective Clothing
Materials.'' EPA requests comment on whether these standards should
govern the mandatory glove testing, or whether there are other
standards or requirements that should be imposed. In addition, EPA is
proposing to require employers whose employees are exposed to NMP in
paint and coating removal products to develop and institute personal
protective equipment programs. These programs must be in writing,
specific to the affected workplace, and include provisions relating to
the proper selection, use, and maintenance of equipment. EPA requests
comment on whether the proposed requirements for personal protective
equipment programs are appropriate and complete, whether less
burdensome requirements would similarly allow risk to be reduced so
that it is no longer unreasonable, or whether EPA should cross
reference the OSHA regulations on personal protective equipment,
specifically 29 CFR 1910.132-134 and 29 CFR 1910.138.
ii. Risk reduction of second co-proposed approach. Reducing risks
to workers so that they would not be unreasonable requires a
combination of a concentration limitation and worker protection
programs that include PPE and hazard communication because
concentration limits or a worker protection program alone would not be
sufficient to reduce the risks to workers so that they are no longer
unreasonable. For this reason, the second co-proposal aims to reduce
the risks to workers by placing requirements on product formulators and
commercial users.
Reducing exposure to NMP requires consideration of routes of
exposure as well as user behaviors, such as wearing appropriate PPE
(i.e., specialized gloves that are effective for the specific
formulation used, impervious clothing and a respirator). The dermal
route is the primary contributor to exposures from NMP; however, vapor
deposition and subsequent absorption through skin and inhalation are
also important exposure pathways that must be considered in determining
a person's exposure to NMP. Even when wearing specialized gloves,
dermal absorption of NMP from the vapor phase typically contributes
significantly to human exposure. EPA's calculations for dermal exposure
are based on a person having up to 25 percent of exposed skin surface
(e.g., arms, head and neck), providing significant exposure to NMP even
with impervious glove use (Ref. 3). Thus, the use of impervious long
pants and shirts is needed to minimize the area of exposed skin and
thus reduce the risk associated with using NMP for paint and coating
removal. To address the exposures to NMP use in paint and coating
removal via dermal exposure from both direct contact and vapor
deposition, and via inhalation exposure, the following combination is
required: Specialized gloves that are effective for the specific
formulation used; a respirator with an APF of 10; and impervious
clothing covering the body. This combination, as part of a worker
protection program, will reduce occupational exposures so that the
benchmark MOE is exceeded, provided that the concentration of NMP in
the formulations used in paint and coating removals does not exceed 35
percent (Ref. 75). Therefore, EPA believes that any remaining
occupational risks would not be unreasonable.
Specialized gloves are an important component of reducing exposure
and, thus, must be effective. The presence of co-solvents in the paint
and coating removal product containing NMP can result in inadvertent
exposure to NMP. Most paint and coating removal products containing NMP
contain co-solvents (Ref. 34). Gloves proven to resist permeation or
breakthrough from pure NMP have been shown to experience degradation
and permeation with these co-solvents especially those that are small-
molecule, volatile solvents. For this reason, it is not possible to
know which type of glove provides adequate protection from products
containing NMP with any co-solvents without testing the formulation of
each product for glove breakthrough and permeation. When working with
formulated products, the chemical component with the shortest break-
through time must be considered when selecting the appropriate glove
type for protection against chemical hazards unless glove-specific test
data are available (Ref. 82). Risks may not be reduced if the
appropriate gloves are not identified through testing.
Consumers could have access to NMP formulations identical to those
available to commercial users. This co-proposed approach would attempt
to address the unreasonable risk to consumers through the combination
of labeling and product reformulation. The product reformulation would
be as discussed previously. If consumers using NMP formulations which
did not exceed 35% of NMP were to consistently follow all the warnings
on the label (specifically, if the consumer were to use a new pair of
the formulation-specific gloves identified on the label each time the
product is used; and were to adequately ventilate the workspace; and
not spray-apply the product; and if they were to wear clothing that
covers exposed skin; and properly fit and use a respirator of APF 10,
such as a NIOSH-certified air-purifying elastomeric half-mask
respirator equipped with N100, R100, or P100 filters) then the consumer
exposures to NMP would be expected to result in MOEs that approach the
benchmark MOE of 30 (Ref. 76).
[[Page 7509]]
Under real-world conditions, EPA expects that not all consumers
will adequately follow the label to reduce risk to a level above the
benchmark MOE. The Agency is requesting comment on whether incomplete
adherence to the label might still suffice to reduce risks presented by
NMP in paint and coating removal so that those risks are no longer
unreasonable. EPA also requests comment on whether the voluntary nature
of consumer use and the information provided on the label that would
allow consumers to avoid risk below the benchmark MOE if label
directions were followed should be a factor in determining whether any
remaining risk associated with this exposure scenario is unreasonable,
and if so, how.
EPA is also requesting comment on how labels may be constructed to
effectively communicate risk and instructions on how to use the
product, such as information on label content, placement of
information, pictures, and font size and color; how to construct a
label to effectively communicate and improve the user's understanding
of risk and protective measures. EPA requests that this be supported by
data demonstrating the effectiveness of a label approach, particularly
as it pertains to susceptible sub-populations or individuals with
limited English proficiency or low literacy in any language.
EPA requests comment on the efficacy of this co-proposed option,
including on individual components.
iii. Concerns regarding second co-proposed approach. EPA has
identified several concerns regarding this co-proposed option related
to risk reduction for commercial users and for consumers. For
commercial users, many of these concerns relate to the use of PPE.
Although respirators in conjunction with the use of appropriate
formulation-tested gloves could reduce exposures to levels that are
protective of acute and chronic risks, respirators are not EPA's
preferred approach to decrease exposures. Not all workers may be able
to wear respirators, even those with a lower APF. For a discussion of
the use of respirators and the associated respiratory protection
program, see Unit VI.C. Given equipment costs and the costs of
establishing a worker protection program, which involves training,
respirator fit testing and the establishment of a medical monitoring
program, EPA anticipates that most companies would choose to switch to
substitutes instead of adopting a program for this type of PPE to
continue using NMP in paint and coating removal. As recommended by the
SBAR panel, EPA is requesting comment on and information about
workplace experience with worker protection programs and air monitoring
for NMP (Ref. 27). Specifically, EPA seeks comment on whether companies
would opt to substitute an alternate chemical or process instead of
implementing a worker protection program for PPE. Additionally, EPA is
requesting comment on the cost to achieve reduced exposures in the
workplace or to transition to alternative chemicals or technologies.
Under this approach, risks to consumers are only addressed to the
extent that consumers understand and follow the required label
information. While the Agency expects that some number of consumers who
read the labels of paint and coating removal products containing NMP
would understand this information and take appropriate steps to reduce
their risks based on label information, as noted in Unit V.C., studies
have shown that consumers do not consistently pay attention to labels
for hazardous substances; consumers, particularly those with lower
literacy levels, often do not understand label information; consumers
often base a decision to follow label information on previous
experience and perceptions of risk; even if consumers 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 have varying
behavioral responses to warning labels.
Even for those consumers who understand and follow the label, EPA
expects some number will not follow the label instructions precisely or
may be unable to readily locate the specialized gloves or the
respirator indicated on the label (Ref. 28). Further, it is unlikely
that consumers would have the fit of their respirator tested, which is
important part of the proper use, and thus effectiveness, of a
respirator, or that they would wear a new pair of specialized gloves
for each use of the product containing NMP. EPA emphasizes that product
labels are not equivalent to worker protection programs in which risks
are reduced through, among other things, training programs,
requirements that include proper testing and use of respirators, and
requirements to use specialized gloves each time the product is used.
EPA is unable to determine how many consumers would read and take
all appropriate action based on label information, and to what extent
they could effectively carry out those actions such that their exposure
would be reduced.
As under the first co-proposed approach, manufacturers, processors,
and distributors would be required to provide downstream notification
of these requirements under TSCA section 6(a)(3), and limited
recordkeeping would be required under TSCA section 6(a)(4).
C. Adverse Health Effects and Related Impacts That Would Be Prevented
by the Proposed Options
EPA is co-proposing these options to prevent exposure to NMP from
paint and coating removal and thus prevent the risks of adverse effects
and associated impacts. As discussed in Unit XII.C., the range of
adverse health effects from NMP includes developmental toxicity
resulting in decreased birth weight or fetal death, kidney toxicity,
liver toxicity, immunotoxicity, and reproductive toxicity (Ref. 3).
These health effects associated with exposure to NMP are serious and
can have impacts throughout a lifetime. The following is a discussion
of the impacts of significant acute and chronic non-cancer effects
associated with NMP exposure during paint and coating removal,
including the severity of the effect, the manifestation of the effect,
and how the effect impacts a person during their lifetime.
1. Developmental effects--acute exposures. The NMP risk assessment
identified developmental effects as the most sensitive endpoint for
acute exposure to NMP. Specifically, this assessment identified fetal
death as the critical effect of acute exposures over the course of a
day. Fetal death or fetal mortality includes miscarriage, spontaneous
abortion, or stillbirth, depending on when in the pregnancy it occurs.
Fetal death may result from a single maternal exposure to NMP at a
developmentally critical period (Ref. 3). There are increased risks of
fetal death for pregnant women who use NMP for paint and coating
removal as consumers. EPA estimates that 732,000 consumers use NMP for
paint and coating removal each year; of them, approximately 38,000 are
estimated to be pregnant women. EPA estimates that approximately 11,300
of these pregnant women are estimated to experience acute exposure to
NMP at levels that would result in an MOE below the benchmark of 30.
Additionally, there are increased risks of fetal death for a subset of
pregnant women among the approximately 8,800 female workers in 4,300
commercial facilities or companies that use NMP for paint and
[[Page 7510]]
coating removal. Of these female workers, approximately 500 are
estimated to be pregnant, and, of them, approximately 160 are estimated
to have acute exposure to NMP at levels that would result in an MOE
below the benchmark of 30 for fetal death (Ref. 4). The basis for these
calculations are shown in section 5.2.1 of the Economic Analysis (Ref.
4).
Researchers aiming to improve early childhood health outcomes have
identified the most sensitive time in a pregnancy as the first few
weeks following conception, before a woman may be aware she is
pregnant. In the context of maternal welfare and risk reduction,
``women often delay assessing and improving their health until after
confirmation of pregnancy, putting their baby at risk during the
critical early developmental stages'' (Ref. 81). Approximately 35% of
pregnancies in the United States are unplanned (Ref. 83); consequently,
many women who are pregnant may not have taken or be prepared to take
steps to reduce risks to the developing fetus during early stages of
pregnancy. Maternal exposure to NMP in paint and coating removal may
occur before a woman realizes she is pregnant. As such, even if she is
aware of the risks of exposure to NMP, she may not take steps to reduce
risks of fetal death.
Even if they are aware of their pregnancy, women may not wish to
disclose this fact to their employers; although legal protections are
in place, many women ``feel they may lose their job, may not be
considered for a promotion, or may have a promotion taken away if they
announce they are pregnant'' (Ref. 81). Similarly, the American College
of Occupational and Environmental Medicine has found that ``while it is
illegal for an employer to terminate a worker because of pregnancy,
such fears may not be groundless for some workers'' (Ref. 83).
Consequently, pregnant women may attempt to ``minimize their
pregnancy'' (Ref. 81) and may not be vocal in their workplace about
reducing risks to their pregnancy. This could increase chances of
exposure to chemicals such as NMP that present a risk of fetal death.
Exposure to NMP in paint and coating removal during a single day
(over 8 hours) was found to present risks of fetal death (Ref. 3). The
impacts of fetal death, including miscarriage or stillbirth, include
emotional impacts on the woman experiencing the death of a fetus, and
also present significant emotional impacts for partners and spouses.
Emotional impacts and other mental health effects of miscarriage or
stillbirth can include depression, anxiety, grief, and guilt. Mental
health research has consistently identified both miscarriage (defined
as fetal death occurring before the 20th week of gestation) and
stillbirth (defined as fetal death occurring after the 20th week of
gestation) as a significant emotional burden that can persist for more
than a year and sometimes up to three years following the event of
fetal death (Ref. 84). Compared with their peers, women who have
experienced fetal death ``exhibit significantly elevated levels of
depression and anxiety in the weeks and months following the loss,
compared with samples of pregnant, community or postpartum women''
(Ref. 85). Psychologists see miscarriage and stillbirth as ``an
unanticipated, often physically as well as psychologically traumatic
event representing the death of a future child and disruption of
reproductive plans. Physiologically, it marks the end of a pregnancy,
and psychologically it may produce doubts about procreative
competence'' (Ref. 86). Other descriptions of fetal death similarly
characterize it as ``a significant psychosocial stressor that results
in a high level of dysphoria and grief'' (Ref. 87). Consequently, women
who experience the death of a fetus are at increased risk for
depression, anxiety, and other psychiatric disorders (Ref. 86).
Major depressive disorder has been identified in between 10% to 50%
of women after a miscarriage, depending on the measures used (Refs. 88
and 89). According to the National Institutes of Mental Health,
persistent depressive disorder is a depressed mood that lasts for at
least two years. Symptoms can include difficulty concentrating, sleep
pattern disruptions, appetite or weight change, thoughts of suicide or
suicide attempts, loss of interest in hobbies or activities, decreased
energy, and aches, headaches, or digestive problems without a clear
physical cause and that do not ease even with treatment (Ref. 90).
Depression can affect an individual's physical health and their ability
to work. Additionally, depression in one family member can also result
in increased instance of illness or morbidity in other family members
(Ref. 91). Treatment can require several types of attempted
pharmaceutical or psychological therapies, and, in the case of
depression following fetal death, can persist for years (Ref. 89).
Depression is not the only emotional impact of fetal death; many
women also experience intense and persistent anxiety. Researchers have
found that ``a significant percentage of women experience elevated
levels of anxiety after a miscarriage up until about 6 months post-
miscarriage, and they are at increased risk for obsessive-compulsive
and posttraumatic stress disorder'' (Ref. 89).
In addition to depression and anxiety, a primary component of the
emotional burdens presented by fetal death is guilt. As one researcher
explained, women search for answers to what they perceive as an
inexplicable trauma: ``They will spend enormous amounts of emotional
energy trying to explain why it happened . . .. They often blame
themselves, even when it is inaccurate, to help make sense of it. Women
may torment themselves with guilt and blame, rewriting the story, so to
speak: `If I hadn't gone to the grocery store' or `If I didn't stay up
so late.' It's a way of coping with the loss'' (Ref. 92).
Related to these emotional impacts, one study found that ``the mean
annual suicide rate within one year after miscarriage was significantly
higher (18.1 per 100.000) than the suicide rates both for women who
gave birth (5.9) and for women in the general population (11.3) in
Finland between 1987 and 1994'' (Ref. 86).
Women experiencing miscarriages or stillbirths are not the only
individuals affected by fetal death. Researchers have also documented
the ways in which the woman's partners are affected by the loss (Ref.
86). Recent research has found that male partners experience more grief
over miscarriages than previously assumed (Ref. 92) and that in 25% of
the cases studied, the intensity of fathers' grief exceeded that of the
mothers' (Ref. 93).
Additional burdens from fetal death can be felt throughout the
affected family, including by subsequent children, since the
depression, anxiety, and guilt initiated by fetal death may persist
during and after any subsequent successful pregnancy (Ref. 92). As a
result, future pregnancies and children can be adversely affected by
fetal death during the mother's previous pregnancies due to persistent
psychological impacts leading to maternal stress or depression that can
last up to three years (Refs. 94 and 85). As a result of this stress or
depression, complications during subsequent pregnancies can occur.
Maternal anxiety or depression during pregnancy is associated with pre-
term birth, decreased birth weight, and impacts on fetal brain
development as a result of abnormal uterine blood flow and increased
maternal cortisol levels (Ref. 94). Maternal anxiety and depression,
including that initiated by fetal death during a previous pregnancy, is
also
[[Page 7511]]
associated with a higher risk of maternal postpartum depression (Ref.
85), which can lead to poor infant care, and infant cognitive delay
(Ref. 94). For some children born to women who previously experienced
the death of a fetus, there may be disorganized or insecure maternal
attachment or bonding (Ref. 95), and maternal perinatal mood symptoms
that may alter a child's emotional or health outcomes (Refs. 85 and
86). For example, available data indicate that ``12-month-old infants
born following prenatal loss were reported to show higher rates of
disorganized attachment patterns to their mothers than children born
into families without a loss history. Thus, even if there is no
persistence of mood disturbance into the postnatal period, there may
still be adverse effects of a previous prenatal loss on the parent-
child relationship and child outcomes'' (Ref. 85). Similarly, maternal
post-partum depression or anxiety has been found to have ``deleterious
effects on maternal-child attachment, child behavior, and cognitive and
neuroendocrine outcomes that persist into adolescence'' (Ref. 85). In
this way, a single instance of fetal death may result in years of
emotional impacts for the mother and may potentially affect the health
and well-being of future children. In addition to depression and
anxiety, emotional impacts can take the form of grief, envy, or
isolation.
Similarly, a woman's attitude towards a pregnancy does not
necessarily correlate with the emotional impact resulting from fetal
death. Although ambivalence toward pregnancy was associated with
different emotional impacts (greater association with depressive
symptoms, rather than grief), they were found to be as intense as in
women who were not ambivalent about their pregnancy (Ref. 86).
As a result, fetal death at any stage of a pregnancy, even when
experienced by a woman who is ambivalent about that pregnancy, may
result in intense emotional impacts and psychological morbidities, for
both the mother and other family members; these impacts can include
depression and anxiety and, in many cases, could persist and
potentially impact future pregnancies and children.
Additionally, it is important to note that fetal death can present
health risks to the woman; in some cases, maternal death can result.
From 1981 to 1991, the Centers for Disease Control and Prevention (CDC)
recorded 62 cases of maternal mortality following spontaneous abortion
at or before 20 weeks of fetal gestational age (an overall case
fatality rate of 0.7 per 100,000 spontaneous abortions) (Ref. 96).
Leading causes of maternal mortality during these incidents of fetal
death were infection, hemorrhage, or embolism (Ref. 96). The CDC has
noted that this case fatality rate is likely the result of
underreporting, and that ``the true number of deaths related to
pregnancy might increase from 30% to 150% with active surveillance''
(Ref. 97).
Even when the effects of fetal death are less severe, a miscarriage
or stillbirth can have considerable adverse consequences on an
individual, family, or community. Commercial and consumer users of NMP
in paint and coating removal are at risk of fetal death from typical
use of products containing NMP; although EPA is unable to quantify the
precise number or frequency of fetal deaths that may occur as a result
of exposure to NMP during paint and coating removal, reducing the risks
of exposure would benefit women, their families, and the public at
large by reducing risks of fetal death in a population of approximately
12,000 pregnant individuals (consumers and workers) likely to
experience acute exposures that present risks of fetal death. Details
on how EPA estimated the number of individuals is in section 5.2.1 of
the Economic Analysis (Ref. 4).
2. Developmental effects--chronic exposures. The NMP risk
assessment identified developmental effects as the most sensitive
endpoint for chronic exposure to NMP. Specifically, the assessment
selected decreased birth weight as the critical effect resulting from
repeated exposures to women of child-bearing age. It is not known if
there is a window of exposure that may pose greater risks to the fetus;
therefore, any repeated exposure to NMP could increase risks to the
fetus for developmental effects.
Rather than accumulating over a lifetime, risks were found for
workers exposed to NMP during paint and coating removal over the course
of a workweek, or five days. Even when maternal exposure ceased, the
decreased fetal body weight was found to be a persistent adverse effect
(Ref. 3); consequently, a relatively brief period of maternal repeated
exposure to NMP in typical paint and coating removal can cause fetal
weight decreases, resulting in life-long impacts. There are increased
risks of decreased fetal weight for the subset of pregnant women among
the approximately 8,800 female workers in 4,300 commercial facilities
or companies that use NMP for paint and coating removal. EPA estimates
that there are approximately 500 pregnant women working in these
commercial facilities (Ref. 4). A subset of these 500 pregnant would
have chronic exposure to NMP at levels that would result in an MOE
below the benchmark of 30 for decreased fetal weight (Ref. 3).
Decreased fetal weight can lead to reduced or low birth weight,
which can have lifelong effects on a person and their family. Most
cases of reduced or low birth weight are pre-term or premature birth;
as a result, until recently, health impacts of reduced or low birth
weight have been difficult to separate from the effects due to
premature birth or gestational age. However, epidemiological, social,
and medical research in the past several decades has isolated several
health effects of reduced or low birth weight separate from gestational
age at birth. Full-term babies may be born at low or reduced birth
weights as a result of fetal growth restriction; these infants are
usually referred to as small for gestational age, and ``may have low
birth weight because something slowed or stopped their growth in the
womb'' (Ref. 98). Low birth weight is typically defined as birth weight
of less than 5.5 pounds, or 2,500 grams. Very low birth weight is
typically defined as less than 1,500 grams (Ref. 99).
Low birth weight can have significant impacts on childhood
development and the incidence of future diseases (Ref. 100); reduced
birth weight can cause serious health problems for some children (Ref.
98), as well as long-term impacts on their lives as adults (Ref. 101).
Health impacts of low or reduced birth weight can begin at birth.
According to the CDC, low birth weight infants may be more at risk for
many health problems as neonates (Ref. 99); other medical authorities
report that health impacts for infants with low birth weight include
low oxygen levels at birth, inability to maintain body temperature;
difficulty feeding and gaining weight; infection; breathing problems
such as respiratory distress syndrome; neurologic problems, such as
intraventricular hemorrhage (bleeding inside the brain);
gastrointestinal problems such as necrotizing enterocolitis (a serious
disease of the intestine), and a greater risk of Sudden Infant Death
Syndrome (Ref. 102). These effects and health impacts have clear
implications for the infant's future health and survival, and can cause
emotional stress and anguish for families of the infant.
Effects of reduced or low birth weight can persist beyond infancy.
It can affect growth: Low birth weight has been found to be ``a major
risk factor for children's physical growth in the early
[[Page 7512]]
years and there is no evidence of catch-up by age 2'' (Ref. 103). In
populations that may already be at risk for poor health outcomes,
children with reduced birth weight or who were small for gestational
age continued to be significantly smaller in all measures (height,
weight, and head circumference) than their normal birth weight
counterparts at age 3 (Refs. 104 and 105), and generally smaller
between ages 4 through 7 (although the differences were small) (Ref.
104).
A child's size is not the only potential effect of reduced or low
birth weight. Many studies have identified increased risk of cognitive,
behavioral, and neurological problems in children and adolescents who
had low birth weight or who were small for gestational age (Refs. 106
and 107). A large cohort study that followed infants born at full term
with reduced birth weight (small for gestational age) found that
``children of both genders who were born [small for gestational age]
are at higher risk of learning difficulties'' (Ref. 106), with girls
with the lowest birth weight experiencing an increased risk of
attention problems (Ref. 106).
Other studies have confirmed the impact of reduced or low birth
weight on academic success in childhood; researchers note that compared
to their normal birth weight siblings, low birth weight children are
less likely to be in excellent or very good health in childhood. They
also score significantly lower on reading, passage comprehension, and
math achievement tests. Low birth-weight children are roughly one-third
more likely to drop out of high school relative to other children (Ref.
100).
After childhood, the health, social, and financial impacts of
reduced or low birth weight can continue. In many cases, an
individual's size may continue to be affected. The difference in growth
during adolescence and early adulthood varies by sex. Female adults who
were very low birth weight infants tend to be the same size as their
peers of average birth weight by age 20, while male adults ``remain
significantly shorter and lighter than controls'' (Ref. 109). However,
this may have its own risks: ``Since catch-up growth may be associated
with metabolic and cardiovascular risk later in life, these findings
may have implications for the future adult health of [very low birth
weight] survivors'' (Ref. 109).
In terms of health effects, low birth weight can continue to have
significant negative effects on adults. Researchers have found that low
birth weight increases the probability of being in fair or poor health
as an adult. Specifically, ``low birth weight children are nearly twice
as likely as their normal birth-weight siblings to be in problematic
health by ages 37-52 (23% versus 12%) (Ref. 100). Specific risks
associated with low birth weight (separate from pre-term birth or
gestational age) include increased risk of renal disease (Ref. 110);
increased risk of asthma, diabetes, stroke, heart attack, or heart
disease by age 50 (compared to average weight siblings) (Ref. 100); and
increased risk of clinically verified hyperkinetic disorder, including
attention deficit hyperactivity disorder (Ref. 111). Adults who were
low birth weight babies may be more likely to have certain health
issues such as diabetes, heart disease, high blood pressure, metabolic
syndrome, and obesity (Ref. 98).
Additionally, there are financial implications for adults who were
low birth weight; low birth weight has been found to lower labor force
participation and labor market earnings over an individual's lifetime
(Ref. 100). Specifically, ``low birth weight is linked to a 10%
reduction in hourly wages from ages 18-26, compared to the wages of
normal birth-weight siblings, but a 22% reduction in wages from ages
37-52. Low birth-weight children, relative to their normal birth-weight
siblings, work 7.4% fewer hours in adulthood'' (Ref. 100).
Decreased fetal weight and low birth weight are strongly associated
with a number of adverse health effects in adults. The Barker
Hypothesis (Ref. 112) was among the first to identify a pattern between
neonatal health and cardiovascular disease. Subsequent research in
laboratory animals and in human epidemiological studies confirmed this
pattern and extended the observations to include the relationship
between delayed fetal growth, low birth weight and metabolic syndrome,
which encompasses a host of adverse outcomes, such as hypertension,
insulin resistance, obesity and type 2 diabetes mellitus (Refs. 113,
114, and 115). Diseases such as cardiovascular disease, hypertension,
obesity and diabetes mellitus have a tremendous impact on public
health. For example, according to the CDC, heart disease remains the
nation's leading cause of death (Ref. 116). In addition to causing
premature mortality, the monetary costs of cardiovascular disease were
estimated at $209.3 billion in direct costs and $142.5 billion in
indirect costs, for a total of $351.8 billion (Ref. 116). A number of
health disparities are associated with cardiovascular disease.
Cardiovascular disease causes more deaths in women than men, and in
black Americans, compared to white (Ref. 116). Years of potential life
lost before age 75 from heart disease is nearly double for Black or
African Americans relative to White, Non-Hispanic Americans (Ref. 116).
Several of these health effects associated with reduced fetal
growth and low birth weight fall within the definition of metabolic
syndrome, which is generally defined as the presence of 3 or more of
the following: Abdominal obesity (waist circumference >=88 cm in women
or >=102 cm in men); low HDL cholesterol (<50 mg/dL in women or <40 mg/
dL in men); elevated triglycerides (>=150 mg/dL); elevated fasting
blood glucose (>=100 mg/dL or use of oral hypoglycemic medication or
insulin or both); or elevated blood pressure (at least 1 of the
following: Systolic >=130 mmHg, diastolic >=85 mmHg, or use of
antihypertensive medication). Epidemiological studies indicate a
strong, consistent association between low birth weight and metabolic
syndrome (Ref. 113). The symptoms associated with metabolic syndrome
are in turn associated with increased risk of cardiovascular disease
and diabetes (Ref. 117).
Collectively, the sign, symptoms and diseases associated with
delayed fetal growth and small birth weight present an enormous burden
on public health. The extent that the development of adult disease is
rooted in reductions in fetal and neonatal growth could limit the
success of adult lifestyle changes in modifying these effects.
Therefore, prevention must be focused on assuring fetal and neonatal
health and preventing adverse impacts on growth rates.
Researchers highlight the fact that low birth weight can occur in
every demographic group, and that even though most babies with low
birth weight have normal outcomes, as a whole, infants with low birth
weight ``generally have higher rates of subnormal growth, illnesses,
and neurodevelopmental problems. These problems increase as the child's
birth weight decreases'' (Ref. 118). Additionally, by using sibling
comparisons and cohort studies, the effects of low birth weight have
been found to persist even when accounting for ``the independent
effects of birth order, mother's age at birth, birth year cohort, race/
ethnicity, family structure, parental income, and parental fertility
timing'' (Ref. 100).
Though most research has focused on infants with low or very low
birth weight, it is important to note that children with reduced, but
clinically normal, birth weights (2,500 to 2,999 grams) are also at
increased risk from the health, academic, social, and financial effects
described.
[[Page 7513]]
In this way, reduced or low birth weight resulting from maternal
exposure to NMP during paint and coating removal can have serious and
life-long impacts on individuals and their families, including their
future family members. Even when birth weight is not reduced to the
clinical definition of low, the decrease in fetal weight can have
significant impacts. Additionally, it is important to note that the
impacts of low birth weight go beyond affected individuals and their
families; reduced and low birth weight ``results in substantial costs
to the health sector and imposes a significant burden on society as a
whole'' (Ref. 101).
3. Body weight reductions--chronic exposures. While the impact of
decreased body weights in adult animals may be minimal, decreased body
weight gain in pregnant females, in particular, may contribute to
negative developmental outcomes as well as impacts on adult health
(Refs. 119 and 120).
4. Kidney toxicity--chronic exposures. There are increased health
risks for liver toxicity for many of the approximately 30,300 workers
in 4,300 commercial facilities or companies that use NMP for paint and
coating removal (Ref. 4). Exposure to NMP can cause kidney damage. This
damage may result in signs and symptoms of acute kidney failure that
include; decreased urine output, although occasionally urine output
remains normal; fluid retention, causing swelling in the legs, ankles
or feet; drowsiness; shortness of breath; fatigue; confusion; nausea;
seizures or coma in severe cases; and chest pain or pressure. Sometimes
acute kidney failure causes no signs or symptoms and is detected
through lab tests done for another reason.
Kidney toxicity means the kidney has suffered damage that can
result in a person being unable to rid their body of excess urine and
wastes. In extreme cases where the kidney is impaired over a long
period of time, the kidney could be damaged to the point that it no
longer functions. When a kidney no longer functions, a person needs
dialysis and ideally a kidney transplant. In some cases, a non-
functioning kidney can result in death. Kidney dialysis and kidney
transplantation are expensive and incur long-term health costs if
kidney function fails (Ref. 56).
The monetary cost of kidney toxicity varies depending on the
severity of the damage to the kidney. In less severe cases, doctor
visits may be limited and hospital stays unnecessary. In more severe
cases, a person may need serious medical interventions, such as
dialysis or a kidney transplant if a donor is available, which can
result in high medical expenses due to numerous hospital and doctor
visits for regular dialysis and surgery if a transplant occurs. The
costs for hemodialysis, as charged by hospitals, can be upwards of
$100,000 per month (Ref. 57).
Depending on the severity of the kidney damage, kidney disease can
impact a person's ability to work and live a normal life, which in turn
takes a mental and emotional toll on the patient. In less severe cases,
the impact on a person's quality of life may be limited while in
instances where kidney damage is severe, a person's quality of life and
ability to work would be affected. While neither the precise reduction
in individual risk of developing kidney toxicity from reducing exposure
to NMP during paint or coating removal or the total number of cases
avoided can be estimated, these costs must still be considered because
they can significantly impact those exposed to NMP.
5. Liver toxicity--chronic exposures. There are increased health
risks for liver toxicity for many of the approximately 30,300 workers
in 4,300 commercial facilities or companies that use NMP for paint and
coating removal (Ref. 4).
Some form of liver disease impacts at least 30 million people, or 1
in 10 Americans. Included in this number is at least 20% of those with
NAFLD. NAFLD tends to impact people who are overweight/obese or have
diabetes. However, an estimated 25% do not have any risk factors. The
danger of NAFLD is that it can cause the liver to swell, which may
result in cirrhosis over time and could even lead to liver cancer or
failure (Ref. 42). The most common known causes to this disease burden
are attributable to alcoholism and viral infections, such as hepatitis
A, B, and C. These known environmental risk factors of hepatitis
infection may result in increased susceptibility of individuals exposed
to organic chemicals such as NMP.
Additional medical and emotional costs are associated with liver
toxicity following chronic exposure to NMP in paint and coating
removal, although these costs cannot be quantified. These costs include
medical visits and medication costs. In some cases, the ability to work
can be affected, which in turn impacts the ability to get proper
medical care. Liver toxicity can lead to jaundice, weakness, fatigue,
weight loss, nausea, vomiting, abdominal pain, impaired metabolism, and
liver disease.
Depending upon the severity of the jaundice, treatments can range
significantly. Simple treatment may involve avoiding exposure to NMP
and other solvents; however, this may impact an individual's ability to
continue to work. In severe cases, liver toxicity can lead to liver
failure, which can result in the need for a liver transplant. Even if a
donor is available, liver transplantation is expensive (with an
estimated cost of $575,000) and there are countervailing risks for this
type of treatment (Ref. 44). The mental and emotional toll on an
individual and their family as they try to identify the cause of
sickness and possibly experience an inability to work, as well as the
potential monetary cost of medical treatment required to regain health,
are significant.
6. Reproductive toxicity. There are increased risks for these
reproductive effects for many of the approximately 30,300 workers in
4,300 commercial facilities or companies that use NMP for paint and
coating removal (Ref. 4). Similar to effects discussed previously,
while neither the precise reduction in individual risk of developing
this disorder from reducing exposure to NMP or the total number of
cases avoided can be estimated, EPA still considers their impact.
7. Disproportionate impacts on environmental justice communities.
An additional factor that cannot be monetized is the disproportionate
impact on environmental justice communities. As described in Units
VI.C.1.b. and XVI.B.1.b, Hispanic and foreign-born workers, who may
have limited English proficiency, are disproportionately over-
represented in construction trades (Ref. 4), in which NMP is used for
paint and coating removal. Because they are disproportionately over-
represented in this industry, these populations are disproportionately
exposed to NMP during paint and coating removal, and are
disproportionately at risk to the range of adverse health effects
described here.
D. Availability of Alternatives
For almost every situation in which NMP is used to remove paints or
coatings, EPA is aware of a cost-effective, economically feasible
chemical substitutes or alternative methods. The exception is for
critical corrosion-sensitive components of military aviation and
vessels, for which EPA proposes are critical for national security, and
for which EPA proposes an exemption, described in more detail in Unit
XVIII.
EPA considered chemical substitutes and alternative methods
consistent with the requirements of TSCA Section 6(c)(2)(C) and as
similarly recommended by the SBAR panel (Ref.
[[Page 7514]]
27). A full industry profile characterizing manufacturers, processors,
and end users of NMP for paint and coating removal and a use and
substitutes analysis are included in section 2 and 3 of EPA's economic
assessment. (Ref. 4). As described below, EPA proposes that
alternatives are technologically and economically feasible, reasonably
available, and present fewer hazards to human health than NMP in paint
and coating removal. EPA requests comment on whether its conclusion
that substitutes for NMP are available and technically and economically
feasible is accurate and whether its consideration of alternatives was
sufficient to satisfy the requirements of TSCA section 6(c)(2)(C).
Research into the efficacy of chemical substitutes has identified
products currently available for commercial and consumer users of NMP
for paint and coating removal, for a variety of coatings on numerous
substrates (Refs. 58 and 59). Additionally, in most commercial sectors,
NMP is not in widespread use; most sectors use substitute chemicals or
methods, either due to financial considerations, problems with the
efficacy of products containing NMP, or concern for worker or
individual health and safety (Ref. 22). This was emphasized by a small
business that manufactures such products (Ref. 22).
Many producers of paint and coating removal products containing NMP
also produce paint and coating removal products with substitute
chemicals (Ref. 4). This was emphasized by small businesses
participating in the SBAR process (Ref. 27). Thus, there is already
precedent for producers reformulating products to meet demand from
commercial or individual customers.
Based on the frequent use of substitute chemicals or alternative
methods for paint and coating removal in all industries discussed here,
and the formulation and distribution of substitute chemicals for paint
and coating removal by all formulators of products containing NMP (Ref.
4), EPA found that economically feasible alternatives to NMP are
reasonably available for all paint and coating removal uses. Primary
chemical substitutes for NMP in paint and coating removal include
products formulated with benzyl alcohol; dibasic esters; acetone,
toluene, and methanol (ATM); and caustic chemicals. EPA evaluated these
products for efficacy, toxicity, relative hazards compared to NMP, and
other hazards that might be introduced by use of these products (such
as environmental toxicity, increased global warming potential, and
increased flammability or other hazards to users).
EPA's analysis compared the hazard and exposure characteristics of
the chemical paint and coating removal chemicals and products presumed
to be already in use to NMP, to aid in ascertaining the impact on users
of moving to alternative products. EPA used authoritative sources to
characterize efficacy, hazard endpoints and identify effect and no
effect levels. Relative exposure potential was assessed based on
physical chemical parameters and concentrations in formulations, and
exposure potential was considered to be similar to NMP within an order
of magnitude. Product composition was based on publicly available
Safety Data Sheets for products advertised for paint and coating
removal (Ref. 36).
Products based on benzyl alcohol formulations have been identified
as efficacious paint and coating removers in various industry sectors
(Refs. 22 and 27). Consumer products containing benzyl alcohol are
available for sale (Refs. 22, 27, 35, 58, 59, and 61). Regarding
differential hazards between benzyl alcohol and NMP, there are fewer
hazard concerns compared to NMP-based products, and the benzyl alcohol
NOAELs are higher than for NMP, suggesting lower toxicity (Ref. 34).
Regarding differential exposures between benzyl alcohol and NMP, the
relative inhalation and dermal exposure potentials are similar to NMP
(Ref. 34). Taken together, benzyl alcohol-based paint removers are
expected to result in lower risks, primarily due to lower toxicity.
Dibasic ester products can include dimethyl succinate, dimethyl
glutarate and dimethyl adipate. Many NMP products contain dibasic
esters, and given the efficacy of these products users of these
products would not experience much inconvenience if switched to
substitute products that contain solely formulations based on dibasic
esters, without NMP (Ref. 34). Regarding differential hazards between
dibasic esters and NMP, in general, the hazards associated with dibasic
esters are less severe and occur at concentrations suggesting lower
toxicity (Ref. 34). Regarding differential exposures between dibasic
esters and NMP, the relative inhalation exposure potential is similar
to NMP. The relative dermal exposure potential for dibasic esters is
lower, but similar to, NMP (Ref. 34). Taken together, dibasic ester-
based paint removers are expected to result in lower risks, primarily
due to lower toxicity.
ATM products contain acetone, toluene, and methanol. Products
containing these chemicals may remove coatings very quickly, but may
not be effective on every type of coating (Ref. 27). ATM-based products
are composed of chemicals that exhibit a range of hazard
characteristics. Taken together, the components of ATM-based
formulations have comparable hazard concerns to NMP. Regarding
differential exposures between ATM and NMP, the relative inhalation
exposure potentials for acetone, toluene and methanol are higher than
NMP. The relative dermal exposure potentials for acetone, toluene and
methanol are lower, but similar to, NMP (Ref. 34).
Products with caustic chemicals typically include calcium hydroxide
or magnesium hydroxide. In many uses, they can be an effective product,
particularly when multiple coatings are being removed from a substrate.
In contrast to NMP-based products, there are no developmental or other
repeat dose endpoints of concern associated with caustic products (Ref.
34). Caustic products pose acute concerns due to their physical
chemical properties and can cause chemical burns (Ref. 34). The risks
associated with caustic-based products are acute, and may be mitigated
by appropriate and familiar protective equipment. The risks associated
with NMP-based products are both acute and long term (Ref. 3).
In summary, when methylene chloride is excluded from consideration,
the most likely chemical substitutes for NMP in paint and coating
removal do not pose a risk of acute or chronic developmental effects,
generally have lower or similar exposure potential than NMP, and when
acute risks are present, as in the case of caustic chemicals, those
risks are self-limiting by the nature of the adverse effects. The
chemical formulations that seem to present some risks of concern
contain toluene and methanol; however, risks from these chemicals can
be mitigated by the user more easily than risks presented by NMP.
Overall, exclusive use of substitute chemical products for paint and
coating removal instead of NMP would remove the risks of chronic
effects and acute developmental effects without introducing additional
substantial risks to human health.
In addition to examining toxicity to humans, EPA reviewed available
data on the chemicals in the baseline and alternative products for
aquatic toxicity, persistence and bioaccumulation, as a basis for
examining potential environmental toxicity. Only one chemical evaluated
may have significant impacts on aquatic toxicity, with concern for
environmental persistence and/or bioaccumulation. This chemical is
contained in NMP-based paint
[[Page 7515]]
removal products and thus is not considered further.
EPA is also mindful of the risks that may be introduced by
substitute chemicals or methods that increase global warming, and has
examined the global warming potential of the chemical components of
likely chemical substitutes for NMP in paint and coating removal. NMP
does not present concerns for global warming and has a global warming
potential (GWP) of 0 (Ref. 3). Similarly, the GWP values of likely
substitute chemicals in paint and coating removal are: 0 GWP (benzyl
alcohol, ATM) or not assessed (caustics, dibasic esters) (Ref. 24). As
such, EPA has not identified any increased risk of global warming that
would be introduced by use of chemical products as substitutes for NMP
in paint and coating removal.
In addition to human and environmental toxicity, other hazards
associated with chemical methods for paint and coating removal are
risks of fire due to flammability of the chemical product, and
poisoning or acute injury. Risks of fire are serious when using
solvents such as paint and coating removal chemicals. Even among
products that fall within the same general product composition
category, there is meaningful variability in the specific formulations
of paint remover products, and thus in their flammability. Furthermore,
it is impracticable for EPA to predict the specific product
formulations for which use will increase as a result of prohibitions on
NMP in paint and coating removal. It is therefore impracticable for EPA
to forecast whether the flammability of popular paint and coating
removers would generally increase or decrease as a result of the
proposed rule.
In addition to using substitute chemical products, EPA has
identified non-chemical methods for paint and coating removal that can
be used as alternatives to NMP. These methods are already frequently in
use in various industries or by consumers for paint and coating
removal, and are described in more detail in Unit VI.E.
EPA recognizes that all methods of paint and coating removal can
present some hazards. Most of these alternative methods are already in
frequent use, including by consumers and workers who currently use NMP
or other chemicals for some paint and coating removal. The risks
associated with each of these methods, while serious, are generally
acute, related to injury, and can be mitigated through readily
available and easy-to-implement standard safety practices; in contrast,
the acute risks presented by NMP, such as fetal death, require
specialized gloves and are not the type of hazard frequently
encountered when using household products.
E. Impacts of the Proposed and Alternative Regulatory Options
1. First co-proposed approach: Supply-chain approach. The costs of
the first co-proposed approach are estimated to include product
reformulation costs, downstream notification costs, recordkeeping
costs, and Agency costs. The costs of paint and coating removal product
reformulations are estimated to be approximately $7,000 to $14,000 per
year (annualized at 3% over 20 years) and $9,000 to $19,000 (annualized
at 7% over 20 years). The cost for reformulation includes a variety of
factors such as identifying the appropriate substitute chemical for NMP
in the formulation, assessing the efficacy of the new formulation and
determining shelf life. The costs to users of paint and coating
removers containing NMP are (-$1,477,000) to $27,617,000 at a discount
rate of 3% and (-$1,231,000) to $27,638,000 at a discount rate of 7%
(Ref. 4). The costs of downstream notification and recordkeeping on an
annualized basis over 20 years are $100 and $100 using 3% and 7%
discount rates respectively (Ref. 4). Agency costs for enforcement are
estimated to be approximately $114,401 and $111,718 annualized over 20
years at 3% and 7%, respectively. The total cost of the proposed
approach for paint and coating removers containing NMP is estimated to
be (-$1,484,000) to $27,624,000 and (-$1,251,000) to $27,668,000
annualized over 20 years at 3% and 7%, respectively (Ref. 4).
2. Second co-proposed approach: Reformulation, labeling, and PPE
approach. Reformulation costs are estimated to have less of an impact
than those associated with adoption of worker protection programs.
Given equipment costs and the requirements associated with establishing
a dermal and respiratory protection program which involves training,
purchase of specialized gloves, respirator fit testing and the
establishment and maintenance of a medical monitoring program, EPA
anticipates that companies would choose to switch to substitute
chemicals instead of adopting a program for PPE, including with a
performance-based option of meeting an air concentration level of 5 ppm
as an exposure limit for NMP in paint and coating removal, when these
products have a maximum concentration of 35% NMP by weight. The
estimated annualized costs to commercial and consumer users of
switching to this type of dermal and respiratory protection program are
$47,076,900 to $56,130,900 at 3% and $47,245,900 to $56,383,900 at 7%
over 20 years. In addition, there would be higher EPA administration
and enforcement costs under the second co-proposed approach than there
would be with an enforcement program under the first co-proposed
approach. Finally, this option requires that formulators of paint and
coating removal products containing NMP identify which gloves are non-
penetrable by NMP if used for an eight-hour shift; this requires that
the formulators or processors conduct testing, which can have costs of
$15,786 per product (Refs. 4 and 127).
3. Options that exclude downstream notification. For those options
that exclude downstream notification, the options are less effective
and more to challenging to implement. The downstream notification
(e.g., via SDS) provides additional information on the prohibitions
under the proposed option for processors and distributors of NMP or
products containing NMP other than paint and coating removers, and
provides an efficient way for those entities to recognize themselves as
affected by the regulation, which contributes to a more effective
regulation (Ref. 63). In this way, the downstream notification
component of the supply chain approach contributes to the use no longer
presenting an unreasonable risk because it streamlines and aids in
compliance and implementation (Ref. 64).
F. Summary
EPA is co-proposing these two options because the Agency believes
both deserve consideration by commenters. The first co-proposed
approach is necessary so that NMP in paint and coating removal no
longer presents an unreasonable risk to the general population or to
women of childbearing age. It is more cost effective than other
regulatory options EPA identified as potentially reducing risks so that
they are no longer unreasonable, because the proposed option achieves
the benefits of reducing the unreasonable risks so they are no longer
unreasonable for a lower cost than the second co-proposed approach. For
more information, see Section 6 in the Economic Analysis (Ref. 4). As
stated previously in this notice, the first co-proposed approach
includes:
Prohibiting manufacturing (including import), processing,
and distribution in commerce of NMP for use in consumer and commercial
paint
[[Page 7516]]
and coating removal, except for specified uses critical to national
security;
Prohibiting commercial use of NMP for paint and coating
removal, except for specified uses critical to national security;
Requiring that any products containing NMP intended or
used for paint and coating removal be distributed in containers with a
volume no less than 5 gallons;
Requiring downstream notification of the prohibition on
manufacturing (including import), processing, and distribution of NMP
for the prohibited uses; and
Requiring limited recordkeeping.
Technically and economically feasible alternatives to NMP for paint
and coating removal are reasonably available. The supply chain approach
ensures protection of consumers from the unreasonable risk by
precluding the off-label purchase of commercial products by consumers.
The first co-proposed approach is relatively easy to enforce
because key requirements are directly placed on a small number of
suppliers and because the supply chain approach minimizes to the
greatest extent the potential for NMP products to be intentionally or
unintentionally misdirected into the prohibited uses. Enforcement under
the other options would be much more difficult since the key
requirements are directly placed on the large number of product users.
As described in a recent article on designing more effective rules and
permits, ``the government can implement rules more effectively and
efficiently when the universes of regulated sources are smaller and
better-defined. This is because, other factors being equal, governments
can more easily identify, monitor, and enforce against fewer, rather
than more, entities'' (Ref. 63). Under other options, enforcement
activities must target firms that might perform the activity where a
use of NMP is restricted or prohibited. Identifying which
establishments might use paint and coating removers is difficult
because paint and coating removal is not strictly specific to any
industry (Ref. 4).
The second co-proposed approach would allow the continued use of
NMP in commercial and consumer paint and coating removal at up to 35
percent NMP by weight, except for exempt critical national security
uses which can be at any concentration, provided that commercial users
of NMP for paint and coating removal establish a worker protection
program for dermal and respiratory protection.
In addition, the co-proposed approach would require formulators of
products for either commercial or consumer uses other than critical
national security uses to: Reformulate products such that paint and
coating products containing NMP do not exceed a maximum of 35 percent
NMP by weight in product formulations; test gloves for the product
formulations being processed and distributed in commerce to identify
specialized gloves that provide protection for users; label products
with information for consumers and provide information for commercial
users about reducing risks when using the product. This approach would
effectively reduce risk for workers. EPA is requesting comment on
whether this co-proposed approach would be effective at reducing risks
for consumers so that the risks are no longer unreasonable.
XVII. Costs and Monetized Benefits of the NMP Component of the Proposed
Rule, the Alternatives EPA Considered, and Comparison of Costs and
Benefits
EPA proposes that the identified risks from NMP in paint and
coating removal are unreasonable. Apart from that proposed
determination, EPA has evaluated the potential costs and benefits of
the two co-proposed approach and their variations.
A. Costs of the First Co-Proposed Approach
The details of the costs of the first co-proposed approach for NMP
in commercial and consumer paint and coating removal are discussed in
Unit I.E. and in the Economic Analysis (Ref. 4). Under the first co-
proposed option, costs to users of paint and coating removal products
containing NMP are (-$1,477,000) to $27,617,000 at a discount rate of
3% and (-$1,231,000) to $27,638,000 at a discount rate of 7%. Costs of
paint and coating removal product reformulations are estimated to be
approximately $7,000 to $14,000 per year (annualized at 3% over 20
years) and $9,000 to $19,000 (annualized at 7% over 20 years). Costs of
downstream notification and recordkeeping on an annualized basis over
20 years are $100 and $100 using 3% and 7% discount rates respectively.
Agency costs for enforcement are estimated to be approximately $114,401
to $111,718 annualized over 20 years at 3% and 7%, respectively (Ref.
4). Under the first proposed approach, total costs of the proposed rule
relevant to NMP in paint and coating removal are estimated to be (-
$1,484,000) to $27,624,000 and (-$1,251,000) to $27,668,000 annualized
over 20 years at 3% and 7% respectively (Ref. 4).
EPA also found that a use prohibition alone without downstream
notification requirements would not address the unreasonable risks. EPA
estimated the costs of this option to be $5,164,000 to $30,702,000
annualized over 20 years at 3% and $5,409,000 to $30,839,000 annualized
over 20 years at 7% (Ref. 4).
B. Benefits of the First Co-Proposed Approach
As described in Unit XVII.B., there are no monetizable benefits
from mitigating the risks from NMP in consumer and commercial paint and
coating removal. Although the alternatives considered are unlikely to
result in the same health benefits as the first co-proposed option, EPA
was unable to quantify the differences.
C. Comparison of Benefits and Costs of the First Co-Proposed Approach
Based on the costs and benefits EPA can estimate, the monetized
subset of benefits for preventing the risks resulting from NMP in
consumer and commercial paint and coating removal do not outweigh the
estimated monetary costs. However, EPA believes that the balance of
costs and benefits of the proposed regulation of NMP cannot be fairly
described without considering the additional, substantial, non-
monetized benefits of mitigating the non-cancer adverse effects. As
discussed previously, the multitude of potential adverse effects
associated with NMP in paint and coating removal can profoundly impact
an individual's quality of life. Some of the adverse effects associated
with NMP exposure can be immediately experienced and can affect a
person from childhood throughout a lifetime (e.g., low birth weight and
associated impacts). Other adverse effects (e.g., adult immunotoxicity,
kidney and liver failure, or fetal death) can have impacts that are
experienced for a shorter portion of life, but are nevertheless
significant in nature.
While the benefits associated with avoiding the health effects
associated with NMP exposure during paint and coating removal cannot be
monetized or quantitatively estimated, the qualitative discussion
highlights how some of these effects may be as severe as more
traditionally monetizable effects and thus just as life-altering;
therefore the benefits of avoiding these effects are substantial. These
effects include not only medical costs but also personal costs such as
emotional and mental stress that are impossible to accurately measure.
Considering only monetized benefits would significantly underestimate
the benefits of avoiding
[[Page 7517]]
NMP-induced adverse outcomes on a person's quality of life.
Thus, considering costs and the benefits that cannot be quantified
and subsequently monetized (developmental effects, fetal death, adult
body weight reductions, kidney toxicity, liver toxicity, and
immunotoxicity), including benefits related to the severity of the
effects and the impacts on a person throughout a lifetime in terms of
medical costs, effects on earning power and personal costs, emotional
and psychological costs, and the disproportionate impacts on Hispanic
communities and individuals with limited English proficiency, the
benefits of preventing exposure to NMP in paint and coating removal by
an estimated 732,000 consumers and an estimated 30,300 commercial
workers outweigh the costs.
D. Impacts on the National Economy, Small Businesses, Technological
Innovation, the Environment, and Public Health of the First Co-Proposed
Approach
As described in Unit V.B. and in the Economic Analysis, EPA
considered the anticipated effects of this proposal on the national
economy. While the impacts of this rule as a whole are described in
Unit XXIII.C. and the impacts of the NMP component of this proposal are
described in more detail in Unit XVII.A. and in Section 9.3 of the
Economic Analysis (Ref. 4), EPA does not anticipate these impacts
having an effect on the overall national economy. EPA anticipates that
a majority of small businesses will have cost impacts of less than one
percent of the annual revenue, and the majority of small business
bathtub refinishing facilities and professional contractors will have
cost impacts greater than one percent of annual revenue.
The first co-proposed approach is anticipated to drive
technological innovation by formulators of paint and coating removal
products containing NMP, as they continue to develop substitute
products, and refine such products already available. It is also
anticipated to drive technological innovation by formulators of
chemical paint and coating removal products with different chemistries
as well as manufacturers and retailers of alternative methods of paint
and coating removal, particularly those with interest in appealing to
the consumer uses. See section 9.3 in the Economic Analysis (Ref. 4).
The first co-proposed approach is anticipated to have a positive
impact on public health, as described in Unit XVI.C. There is not
anticipated to be a significant impact on the environment, for the
reasons described in Unit XII.D.
E. Costs of the Second Co-Proposed Approach
The details of the costs of the second co-proposed approach for NMP
in commercial and consumer paint and coating removal are discussed in
Unit I.E. and in the supplement to the Economic Analysis (Ref. 127).
Under the second co-proposed option, costs to users of paint and
coating removal products containing NMP are $47,076,900 to $56,130,900
(annualized at 3% over 20 years) and $47,245,900 to $56,383,900
(annualized at 7% over 20 years). Costs of paint and coating removal
product reformulations are estimated to be approximately $15,100 to
$21,100 per year (annualized at 3% over 20 years) and $20,100 to
$28,100 (annualized at 7% over 20 years). Agency costs for enforcement
are estimated to be approximately $1,024,144 and $998,711 annualized
over 20 years at 3% and 7% respectively. Under the second proposed
approach, total costs of the proposed rule relevant to NMP in paint and
coating removal are estimated to be $47,098,000 to $56,146,000 and
$47,274,000 to $56,404,000 annualized over 20 years at 3% and 7%
respectively (Ref. 127).
F. Benefits of the Second Co-Proposed Approach
As described in Unit XVII.B., there are no monetizable benefits
from mitigating the risks from NMP in consumer and commercial paint and
coating removal. Although the second co-proposed option is unlikely to
result in the same health benefits as the first co-proposed option, EPA
was unable to quantify the differences.
G. Comparison of Benefits and Costs of the Second Co-Proposed Approach
Based on the costs and benefits EPA can estimate, the monetized
subset of benefits for preventing the risks resulting from NMP in
consumer and commercial paint and coating removal do not outweigh the
estimated monetary costs. However, EPA believes that the balance of
costs and benefits of the proposed regulation of NMP cannot be fairly
described without considering the additional, substantial, non-
monetized benefits of mitigating the non-cancer adverse effects. As
discussed previously, the multitude of potential adverse effects
associated with NMP in paint and coating removal can profoundly impact
an individual's quality of life. Considering only monetized benefits
would significantly underestimate the benefits of avoiding NMP-induced
adverse outcomes on a person's quality of life.
H. Impacts on the National Economy, Small Businesses, Technological
Innovation, the Environment, and Public Health of the Second Co-
Proposed Approach
As described in Unit V.B. and in the Economic Analysis, EPA
considered the anticipated effects of this proposal on the national
economy. While the impacts of this rule as a whole are described in
Unit XXIII.C. and the impacts of the NMP component of this proposal are
described in more detail in Unit XVII.A. and in the supplement to the
Economic Analysis (Ref. 127), EPA does not anticipate these impacts
having an effect on the overall national economy.
The second co-proposed approach is anticipated to drive
technological innovation by formulators of paint and coating removal
products containing NMP, as they continue to develop substitute
products, and refine such products already available. It is also
anticipated to drive technological innovation by formulators of
chemical paint and coating removal products with different chemistries
as well as manufacturers and retailers of alternative methods of paint
and coating removal, particularly those with interest in appealing to
the consumer uses. See the supplement to the Economic Analysis (Ref.
127).
The second co-proposed approach is anticipated to have a positive
impact on public health, as described in Unit XVI.C. There is not
anticipated to be a significant impact on the environment, for the
reasons described in Unit XII.D.
XVIII. Uses of NMP for Paint and Coating Removal Critical for National
Security
As part of interagency collaboration with the Department of Defense
(DOD) on this proposed rule, EPA is aware that there are specific
military uses for which NMP is essential for paint and coating removal
and for which there are no technically feasible alternatives currently
available. The military readiness of DOD's warfighting capability is
paramount to ensuring national security, which includes ensuring the
maintenance and preservation of DOD's warfighting assets. DOD has
identified mission-critical uses for NMP for ensuring military aviation
and vessel readiness. These mission-critical items require the use of
NMP for the removal of coatings from mission-critical corrosion-
sensitive components on military aviation and
[[Page 7518]]
vessels, including safety-critical components made of specialty
metallic, nonmetallic, and composite materials. As described in this
section, EPA proposes to exempt these uses from the regulations
proposed on NMP in paint and coating removal. This exemption is
proposed for an initial ten-year period from the publication date of a
final rule. EPA will engage with DOD to identify any potential
extension that may need to be granted, by further rulemaking, after
those ten years.
DOD continues and will continue to pursue potential substitutes for
NMP in paint and coating removal. However, for mission-critical
corrosion-sensitive components on military aviation and vessels,
including safety-critical components, DOD has found that currently
available substitute chemicals for paint and coating removal have one
or more technical limitations. These are the same technical limitations
described in Unit VIII., which outlines the proposed exemption for
methylene chloride for similar uses critical to national security.
Under TSCA section 6(g)(1)(B), EPA may grant an exemption from a
requirement of a TSCA section 6(a) rule for a specific condition of use
of a chemical substance or mixture if compliance with the requirement
would significantly disrupt the national economy, national security, or
critical infrastructure. Based on discussions and information provided
by DOD, EPA has analyzed the need for the exemption and concurs with
DOD that compliance with the proposed regulations on the use of NMP in
paint and coating removal would significantly impact national security.
DOD has demonstrated that the reduced mission availability of aircraft
and vessels for military missions or, in the worst case, the loss of
individual military aircraft and vessels, are potential impacts to
military readiness that could result from the proposed prohibition of
NMP in paint and coating removal. Due to the importance of these
military systems for national security, EPA has determined that these
uses of NMP for removal of specialized coatings from military aviation
and vessel mission-critical corrosion-sensitive components, including
safety-critical components, is critical for national security and the
safety of personnel and assets. EPA includes in this exemption
corrosion-sensitive military aviation and vessel mission-critical
components such as landing gear, gear boxes, turbine engine parts, and
other military aircraft and vessel components composed of metallic
materials (specifically high-strength steel, aluminum, titanium, and
magnesium) and composite materials that not only require their coatings
be removed for inspection and maintenance but also would be so
negatively affected by the use of technically incompatible, substitute
paint removal chemicals or methods that the safe performance of the
vessel or aircraft could be compromised.
EPA proposes to grant this exemption for a period of ten years from
the date of promulgation of a final rule, with a potential for
extension, by further rulemaking, after review by EPA in consultation
with DOD. The conditions for this exemption would be: (1) The use of
NMP at any concentration for coating removal by DOD or its contractors
performing this work only for DOD projects is limited to the mission-
critical corrosion-sensitive components on military aviation and
vessels, including safety-critical components; (2) this paint and
coating removal must be conducted at DOD installations, or at Federal
industrial facilities, or at DOD contractor facilities performing this
work only for DOD projects.
This exemption granted under TSCA(6)(g)(1)(B) does not impact or
lessen any requirements for compliance with other statutes under which
the use, disposal, or emissions of NMP is regulated.
As described in Unit XVI.B.3., under the proposed approach, any
paint and coating removal products containing NMP would be required to
be distributed in containers with a volume no less than 5 gallons, as
part of the exemption for uses identified as critical for national
security. Allowing selective use for national security purposes does
not disrupt the efficacy of the supply chain approach described in Unit
XVI.B.3.
In addition to the exemption described in this unit, EPA will
consider granting additional time-limited exemptions, under the
authority of TSCA section 6(g). Details of EPA's request for comment on
such exemption are described in Unit VIII.
XIX. Overview of Uncertainties for NMP in Paint and Coating Removal
A discussion of the uncertainties associated with this proposed
rule can be found in the NMP risk assessment (Ref. 3) and in the
additional analyses for NMP in commercial and consumer paint and
coating removal (Refs. 75 and 76). A summary of these uncertainties
follows.
EPA used a number of assumptions in the NMP risk assessment and
supporting analysis to develop estimates for occupational and consumer
exposure scenarios and to develop the hazard/dose[hyphen]response and
risk characterization. EPA recognizes that the uncertainties may
underestimate or overestimate actual risks. These uncertainties include
the likelihood that exposures to NMP vary from one paint and coating
removal project to the next. EPA attempted to quantify this uncertainty
by evaluating multiple scenarios to establish a range of releases and
exposures. In estimating the risk from NMP in paint and coating
removal, there are uncertainties in the number of workers and consumers
exposed to NMP and in the model inputs and algorithms used to estimate
exposures.
In addition to the uncertainties in the risks, there are
uncertainties in the cost and benefits. The uncertainties in the
benefits are most pronounced in estimating the benefits from preventing
the entirety of the adverse effects (described in Unit XIV.C.) because
these non-cancer benefits generally cannot be monetized due to the lack
of concentration response functions in humans leading to the ability to
estimate the number of population-level non-cancer cases and
limitations in established economic methodologies. Additional
uncertainties in benefit calculations arose from EPA's use of a
forecast from an industry expert to estimate the categories of
alternatives that users might choose to adopt and the potential risks
for adverse health effects that the alternatives may pose. While there
are no products or methods that have comparable developmental or
similar risks, these substitute products and alternative methods do
present hazards. Without information on what alternative methods or
chemicals users of NMP for paint and coating removal are likely to
switch to, and estimates of the exposures for those alternatives. EPA
is unable to quantitatively estimate any change in non-cancer risks due
to use of substitute chemicals or alternative methods instead of using
NMP for commercial or consumer paint and coating removal.
In addition to these uncertainties related to benefits, there are
uncertainties related to the cost estimates. As noted earlier, there is
uncertainty in EPA's estimates of which chemical substitutes or
alternative methods users may adopt instead of NMP for paint and
coating removal, which in turn produces uncertainty as to the cost of
those substitutes or methods. EPA has estimated the cost of substitute
chemicals, but is not able to fully characterize or quantify the total
costs to all sectors for using substitute chemicals or alternative
products. In addition, under certain assumptions EPA's economic
analysis estimates that
[[Page 7519]]
some users of NMP for paint and coating removal will see a cost savings
when switching to substitutes. Standard economic theory suggests that
financially rational companies would choose technologies that maximize
profits so that regulatory outcomes would not typically result in a
cost savings for the regulated facilities. There could be several
reasons that cost savings might occur in the real world. Potential
reasons include lack of complete information or barriers to obtaining
information on the cost savings associated with alternatives as well as
investment barriers or higher interest rates faced by firms.
Additionally, there may be costs associated with these alternatives
that are not adequately accounted for in the analysis. To evaluate the
effect of this uncertainty, EPA has included a sensitivity analysis
that sets the cost savings to zero for these compliance alternatives
(Ref. 4 at Section 7). EPA also recognizes that these firms might
experience positive costs of compliance rather than zero costs, so that
the actual total costs could be higher than those in the sensitivity
analysis. However, EPA has no current basis to estimate these
potentially higher costs, since the available data appear to show that
there are lower cost substitutes available. EPA requests comments on
these assumptions.
Additionally, there are uncertainties due to in the estimates of
the number of affected commercial and consumer users, and for numbers
of processors and distributors of NMP-containing products not
prohibited by the proposed rule who are required to provide downstream
notification and/or maintain records.
EPA will consider additional information received during the public
comment period. This includes scientific publications and other input
submitted to EPA during the comment period.
XX. Major Provisions and Enforcement of the Proposed Rule for NMP in
Paint and Coating Removal
This proposal relies on general provisions in the proposed Part
751, Subpart A, which can be found at 81 FR 91592 (December 16, 2016).
A. Prohibitions and Requirements
Under the first co-proposed approach, the rule, when final, would
(1) prohibit the manufacturing, processing, and distribution in
commerce of NMP for consumer and commercial paint and coating removal,
exempting uses defined as critical for national security (see Unit
XVIII.); (2) prohibit the commercial use of NMP for paint and coating
removal, exempting for uses defined as critical for national security;
(3) require any paint and coating removal products containing NMP to be
distributed in containers with a volume no less than 5 gallons; (4)
require that any commercial use of NMP for paint and coating removal
for uses critical to national security include specific worker
protections; (5) require manufacturers, processors, and distributors of
NMP and all products containing NMP, excluding retailers, to provide
downstream notification of the prohibitions; (6) and require
recordkeeping relevant to these prohibitions. The prohibition on
manufacturing, processing, and distributing in commerce of NMP for all
consumer paint and coating removal would take effect 180 days after
publication of a final rule. Similarly, the prohibition on
manufacturing, processing, and distributing in commerce of NMP for any
paint and coating removal for uses other than those exempted as
critical for national security in volumes less than 5-gallon containers
would take effect 180 days after publication of a final rule. The
prohibition on commercial use of NMP for paint and coating removal
except for the exempted critical national security uses would take
effect 270 days after publication of a final rule. These are reasonable
transition periods because, as noted in Unit XVI.D. and by the small
businesses participating in the SBAR process, many formulators of paint
and coating removers containing NMP also manufacture products for this
use that do not contain NMP (Ref. 27). In addition, alternative paint
removal products exist at comparable expense for users to purchase. Six
months from publication of the final rule is sufficient time to allow
for existing stocks to move through the market place and to allow
manufacturers, processers and distributors and users to plan for and
implement product substitution strategies.
Under the second co-proposed approach, formulators of paint and
coating removal products for either commercial or consumer use would be
required to: (1) Ensure that their paint and coating removal products
containing NMP do not exceed a maximum of 35 percent NMP by weight in
product formulations exempting products used for critical national
security uses (see Unit XVIII.); (2) 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) Label products with information for consumers about the
risks presented by products that contain NMP and how to reduce these
risks when using the products, including identifying which specialized
gloves provide protection against the specific formulation; and (4)
Provide information for commercial users about reducing risks when
using the product, via product labels, SDS, and other methods of hazard
communication. Variations of more than 1% in any component of a paint
and coating removal product containing NMP would be considered a
separate formulation.
Under this co-proposal, commercial users of NMP for paint and
coating removal other than exempt critical national security uses would
be prohibited from using paint and coating removal products or
formulations that contain more than 35 percent by weight of NMP. They
would also be required to establish a worker protection program for
dermal and respiratory protection, including hazard communication,
training, and requirements that workers wear clothing covering most of
the body, i.e., impervious long pants and shirts with long sleeves, use
gloves specified by product formulators (described under formulator
requirements below) and a respirator with APF 10, with an alternative
air exposure limit of 5 ppm achieved through engineering controls or
ventilation.
B. Downstream Notification
EPA has authority under TSCA section 6 of TSCA to require that a
substance or mixture or any article containing such substance or
mixture be marked with or accompanied by clear and adequate minimum
warnings and instructions with respect to its use, distribution in
commerce, or disposal or with respect to any combination of such
activities. Many manufacturers and processors of NMP are likely to
manufacture or process NMP or products containing NMP for other uses
that would not be regulated under this proposed rule. Other companies
may be strictly engaged in distribution in commerce of NMP, without any
manufacturing or processing activities, to customers for uses that are
not regulated. Under both co-proposed approaches, EPA is proposing a
requirement for downstream notification by manufacturers, processors,
and distributors of NMP for any use to ensure compliance with the
prohibition on manufacture, processing,
[[Page 7520]]
distribution in commerce, and commercial use of NMP for the uses
proposed for regulation. Downstream notification is necessary for
effective enforcement of the rule because it provides a record, in
writing, of notification on use restrictions throughout the supply
chain, likely via modifications to the Safety Data Sheet. Downstream
notification also increases awareness of restrictions on the use of NMP
for paint and coating removal, which is likely to decrease
unintentional uses of NMP by these entities. Downstream notification
represents minimal burden and is necessary for effective enforcement of
the rule. The estimated cost of downstream notification on an
annualized basis over 20 years is $100 and $100 using 3% and 7%
discount rates respectively (Ref. 4).
The effective date of the requirement for this notification would
be 45 days after publication of the final rule. This is a reasonable
transition period because regulated entities would only need to provide
additional information on their SDS, which are routinely produced and
updated.
C. Enforcement
Section 15 of TSCA makes it unlawful to fail or refuse to comply
with any provision of a rule promulgated under TSCA section 6.
Therefore, any failure to comply with this proposed rule when it
becomes effective would be a violation of section 15 of TSCA. In
addition, section 15 of TSCA makes it unlawful for any person to: (1)
Fail or refuse to establish and maintain records as required by this
rule; (2) fail or refuse to permit access to or copying of records, as
required by TSCA; or (3) fail or refuse to permit entry or inspection
as required by section 11 of TSCA.
Violators may be subject to both civil and criminal liability.
Under the penalty provision of section 16 of TSCA, any person who
violates section 15 could be subject to a civil penalty for each
violation. Each day of operation in violation of this proposed rule
when it becomes effective could constitute a separate violation.
Knowing or willful violations of this proposed rule when it becomes
effective could lead to the imposition of criminal penalties for each
day of violation and imprisonment. In addition, other remedies are
available to EPA under TSCA.
Individuals, as well as corporations, could be subject to
enforcement actions. Sections 15 and 16 of TSCA apply to ``any person''
who violates various provisions of TSCA. EPA may, at its discretion,
proceed against individuals as well as companies. In particular, EPA
may proceed against individuals who report false information or cause
it to be reported.
XXI. Analysis for Methylene Chloride and NMP in Paint and Coating
Removal under TSCA Section 9 and Section 26(h) Considerations
A. TSCA Section 9(a) Analysis
Section 9(a) of TSCA provides that, if the Administrator determines
in her discretion that an unreasonable risk may be prevented or reduced
to a sufficient extent by an action taken under a Federal law not
administered by EPA, the Administrator must submit a report to the
agency administering that other law that describes the risk and the
activities that present such risk. If the other agency responds by
declaring that the activities described do not present an unreasonable
risk or if that agency initiates action under its own law to protect
against the risk within the timeframes specified by TSCA section 9(a),
EPA is precluded from acting against the risk under sections 6(a) or 7
of TSCA.
TSCA section 9(d) instructs the Administrator to consult and
coordinate TSCA activities with other Federal agencies for the purpose
of achieving the maximum enforcement of TSCA while imposing the least
burden of duplicative requirements. For this proposed rule, EPA has
consulted with OSHA and with CPSC. Both CPSC and OHSA have provided
letters documenting this consultation (Refs. 121 and 122).
CPSC protects the public from unreasonable risks of injury or death
associated with the use of consumer products under the agency's
jurisdiction. Though CPSC has provided guidance to consumers when using
products containing NMP, there are no CPSC regulations regarding NMP in
paint and coating removal. CPSC currently requires that household
products that can expose consumers to methylene chloride vapors must
bear appropriate warning labels (52 FR 34698, September 14, 1987). In a
letter regarding EPA's proposed rulemaking, CPSC stated that ``Some
paint removers are distributed for sale to, and use by, consumers and
thus would likely fall within CPSC's jurisdiction. However, because
TSCA gives EPA the ability to reach both occupational and consumer
uses, we recognize that EPA may address risks associated with these
chemicals in a more cohesive and coordinated manner given that CPSC
lacks authority to address occupational hazards'' (Ref. 121).
OSHA assures safe and healthful working conditions for working men
and women by setting and enforcing standards and by providing training,
outreach, education and assistance. OSHA's methylene chloride standard,
29 CFR 1910.1052, was issued in 1997 and applies to general industry,
construction, and shipyard employment. It sets the PEL for airborne
methylene chloride to an eight-hour TWA of 25 parts per ppm. OSHA has
not set a standard for NMP. OSHA recently published a Request for
Information on approaches to updating PELs and other strategies to
managing chemicals in the workplace (79 FR 61384, October 10, 2014).
OSHA's current regulatory agenda does not include revision to the
methylene chloride PEL, establishment of a PEL for NMP, or other
regulations addressing the risks EPA has identified when methylene
chloride or NMP are used in paint and coating removal (Ref. 122).
This proposed rule addresses risk from exposure to methylene
chloride and NMP during paint and coating removal in both workplace and
consumer settings. With the exception of TSCA, there is no Federal law
that provides authority to prevent or sufficiently reduce these cross-
cutting exposures. No other Federal regulatory authority, when
considering the exposures to the populations and within the situations
in its purview, can evaluate and address the totality of the risk that
EPA is addressing in this proposal and the prior proposal on TCE uses
(Ref. 1). For example, OSHA may set exposure limits for workers but its
authority is limited to the workplace and does not extend to consumer
uses of hazardous chemicals. Further, OSHA does not have direct
authority over state and local employees, and it has no authority at
all over the working conditions of state and local employees in states
that have no OSHA-approved State Plan under 29 U.S.C. 667. Other
Federal regulatory authorities, such as CPSC, have the authority to
only regulate pieces of the risks posed by methylene chloride and NMP,
such as when used in consumer products.
Moreover, recent amendments to TSCA, Public Law 114-182, alter both
the manner of identifying unreasonable risk under TSCA and EPA's
authority to address unreasonable risk under TSCA, such that risk
management under TSCA is increasingly distinct from analogous
provisions of the Consumer Product Safety Act (CPSA), the Federal
Hazardous Substances Act (FHSA), or the OSH Act. These changes to TSCA
reduce the likelihood that an action under the CPSA, FHSA, or the OSH
Act
[[Page 7521]]
would reduce the risk of methylene chloride and NMP in paint and
coating removal so that the risks are no longer unreasonable under
TSCA. Whereas (in a TSCA section 6 rule) an unreasonable risk
determination sets the objective of the rule in a manner that excludes
cost considerations, 15 U.S.C. 2605(a)(b)(4)(A), subject to time-
limited conditional exemptions for critical chemical uses and the like,
15 U.S.C. 2605(g), a consumer product safety rule under the CPSA must
include a finding that ``the benefits expected from the rule bear a
reasonable relationship to its costs.'' 15 U.S.C. 2058(f)(3)(E).
Additionally, recent amendments to TSCA reflect Congressional intent to
``delete the paralyzing `least burdensome' requirement,'' 162 Cong.
Rec. S3517 (June 7, 2016). However, a consumer product safety rule
under the CPSA must impose ``the least burdensome requirement which
prevents or adequately reduces the risk of injury for which the rule is
being promulgated.'' 15 U.S.C. 2058(f)(3)(F). Analogous requirements,
also at variance with recent revisions to TSCA, affect the availability
of action under the FHSA relative to action under TSCA. 15 U.S.C. 1262.
Gaps also exist between OSHA's authority to set workplace standards
under the OSH Act and EPA's amended obligations to sufficiently address
chemical risks under TSCA. To set PELs for chemical exposure, OSHA must
first establish that the new standards are economically feasible and
technologically feasible. 79 FR 61387 (2014). But under TSCA, EPA's
substantive burden under TSCA section 6(a) is to demonstrate that, as
regulated, the chemical substance no longer presents an unreasonable
risk, with unreasonable risk being determined without consideration of
cost or other non-risk factors.
TSCA is the only regulatory authority able to prevent or reduce
risks of methylene chloride or NMP exposure to a sufficient extent
across the range of uses and exposures of concern. In addition, these
risks can be addressed in a more coordinated, efficient and effective
manner under TSCA than under two or more different laws implemented by
different agencies. Furthermore, there are key differences between the
newly amended finding requirements of TSCA and those of the OSH Act,
CPSA, and the FHSA. For these reasons, in her discretion, the
Administrator does not determine that unreasonable risks from the use
of methylene chloride and NMP in paint and coating removal may be
prevented or reduced to a sufficient extent by an action taken under a
Federal law not administered by EPA. However, EPA is requesting public
comment on this issue (i.e., the sufficiency of an action taken under a
Federal law not administered by EPA).
B. TSCA Section 9(b) Analysis
If EPA determines that actions under other Federal laws
administered in whole or in part by EPA could eliminate or sufficiently
reduce an unreasonable risk, section 9(b) of TSCA instructs EPA to use
these other authorities unless the Administrator determines in the
Administrator's discretion that it is in the public interest to protect
against such risk under TSCA. In making such a public interest finding,
TSCA section 9(b)(2) states: ``the Administrator shall consider, based
on information reasonably available to the Administrator, all relevant
aspects of the risk . . . and a comparison of the estimated costs and
efficiencies of the action to be taken under this title and an action
to be taken under such other law to protect against such risk.''
Although several EPA statutes have been used to limit methylene
chloride or NMP exposure (Units III.A. and XII.A.), regulations under
these EPA statutes have limitations because they largely regulate
releases to the environment, rather than direct human exposure. SDWA
only applies to drinking water. CAA does not apply directly to worker
exposures or consumer settings where methylene chloride or NMP are
used. Under RCRA, methylene chloride that is discarded may be
considered a hazardous waste and subject to requirements designed to
reduce exposure from the disposal of methylene chloride to air, land
and water. RCRA does not address exposures during use of products
containing methylene chloride or NMP. Only TSCA provides EPA the
authority to regulate the manufacture (including import), processing,
and distribution in commerce, and use of chemicals substances.
For these reasons, the Administrator does not determine that
unreasonable risks from the use of methylene chloride and NMP in paint
and coating removal could be eliminated or reduced to a sufficient
extent by actions taken under other Federal laws administered in whole
or in part by EPA.
C. Section 26(h) Considerations
EPA has used scientific information, technical procedures,
measures, methods, protocols, methodologies, and models consistent with
the best available science. For example, EPA based its proposed
determination of unreasonable risk presented by the use of methylene
chloride and NMP in paint and coating removal on the completed risk
assessments, which each followed a peer review and public comment
process, as well as using best available science and methods (Refs. 2
and 3). Supplemental analyses were performed to better characterize the
exposed populations and estimate the effects of various control
options. These supplemental analyses were consistent with the methods
and models used in the risk assessment. These analyses were developed
for the purpose of supporting a future regulatory determination: To
determine either that particular risks are not unreasonable or that
those are risks are unreasonable. They were also developed to support
risk reduction by regulation under section 6 of TSCA, to the extent
risks were determined to be unreasonable. It is reasonable and
consistent to consider these supplemental analyses in this rulemaking
for such relevant purposes.
The extent to which the various information, procedures, measures,
methods, protocols, methodologies or models, as applicable, used in
EPA's decision have been subject to independent verification or peer
review is adequate to justify their use, collectively, in the record
for this rule. Additional information on the peer review and public
comment process, such as the peer review plan, the peer review report,
and the Agency's response to comments, can be found on EPA's
Assessments for TSCA Work Plan Chemicals Web page at https://www.epa.gov/assessing-and-managing-chemicals-under-tsca/assessments-tsca-work-plan-chemicals.
XXII. References
The following is a listing of the documents that are specifically
referenced in this document. The docket includes these documents and
other information considered by EPA, including documents referenced
within the documents that are included in the docket, even if the
referenced document is not physically located in the docket. For
assistance in locating these other documents, please consult the
technical person listed under FOR FURTHER INFORMATION CONTACT.
1. EPA (2014). TSCA Work Plan Chemicals. http://www.epa.gov/sites/production/files/2014-02/documents/work_plan_chemicals_web_final.pdf. Retrieved February 25, 2016.
2. EPA. TSCA Work Plan Chemical Risk Assessment Methylene Chloride:
Paint Stripping Use. CASRN 75-09-2. EPA Document # 740-R1-4003.
August 2014. Office of Chemical Safety and Pollution
[[Page 7522]]
Prevention. Washington, DC https://www.epa.gov/sites/production/files/2015-09/documents/dcm_opptworkplanra_final.pdf.
3. EPA. TSCA Work Plan Chemical Risk Assessment N-Methylpyrrolidone:
Paint Stripping Use. CASRN 872-50-5. EPA Document # 740-R1-5002.
March 2015. Office of Chemical Safety and Pollution Prevention.
Washington, DC https://www.epa.gov/sites/production/files/2015-11/documents/nmp_ra_3_23_15_final.pdf.
4. EPA. Economic Analysis of Proposed TSCA Section 6 Action on
Methylene Chloride and N-Methylpyrrolidone (NMP) in Paint and
Coating Removal (EPA Docket EPA-HQ-OPPT-2016-0231; RIN 2070-AK07).
Office of Pollution, Prevention, and Toxics. Washington, DC.
5. EPA. Toxicological Review of Methylene Chloride (CAS No.
75[hyphen]09[hyphen]2). EPA/635/R[hyphen]10/003F. Integrated Risk
Information System, Washington, DC. November 2011.
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Emergency Planning and Community Right to Know Act (EPCRA), Toxics
Release Inventory (TRI) Program, 40 CFR 372.65, July 1, 2002.
7. Hopkins, JS. The Center for Public Integrity. ``Common solvent
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PARLIAMENT AND THE COUNCIL DECISION No 455/2009/EC OF THE EUROPEAN
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17. EPA. TSCA Work Plan Chemicals: Methods Document. http://www.epa.gov/sites/production/files/2014-03/documents/work_plan_methods_document_web_final.pdf. Retrieved February 25,
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18. EPA. A Review of the Reference Dose and Reference Concentration
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19. EPA. Respirator and Glove Specifications for Workers Exposed to
Methylene Chloride in Paint and Coating Removal. 2016.
20. EPA. Supplemental Consumer Exposure and Risk Estimation
Technical Report for Methylene Chloride in Paint and Coating
Removal. 2016.
21. EPA. Recommendation for an Existing Chemical Exposure
Concentration Limit (ECEL) for Occupational Use of Methylene
Chloride and Workplace Air Monitoring Methods for Methylene
Chloride. 2016.
22. EPA. Summary of Stakeholder Engagement, Proposed Rule Under TSCA
Sec. 6 Methylene Chloride and NMP in Paint and Coating Removal.
2016.
23. EPA. Regulatory Options Analysis Matrix for Methylene Chloride
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24. EPA. Regulatory Options Analysis Matrix for N-Methylpyrrolidone
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25. OSHA. ``Respiratory Protection.'' https://www.osha.gov/SLTC/respiratoryprotection/index.html. Retrieved March 16, 2016.
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Safety for the 21st Century Act for Methylene Chloride and N-
Methylpyrrolidone (NMP) in Paint Removers. Office of Chemical Safety
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35. EPA. Consumer Paint and Coating Removers. 2016.
36. Halogenated Solvents Industry Alliance Inc. Petition to Amend
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38. EPA. TSCA Section 6(a)--Re-entry time after Methylene Chloride
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39. Giles, C. EPA. ``Next Generation Compliance.'' Environmental
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[[Page 7525]]
Paint Removers & TCE Rulemakings E.O. 13132: Federalism
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125. EPA. Notification of Consultation and Coordination on Proposed
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Chloride and n-Methylpyrrolidone in Paint Removers and 2)
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XXIII. Statutory and Executive Order Reviews
Additional information about these statutes and Executive Orders
can be found at http://www2.epa.gov/laws-regulations/laws-and-executive-orders.
A. Executive Order 12866: Regulatory Planning and Review and Executive
Order 13563: Improving Regulation and Regulatory Review
This action is an economically significant regulatory action that
was submitted to the Office of Management and Budget (OMB) for review
under Executive Order 12866 and Executive Order 13563 (76 FR 3821,
January 21, 2011). Any changes made in response to OMB recommendations
have been documented in the docket. EPA prepared an economic analysis
of the potential costs and benefits associated with this action, which
is available in the docket and summarized in Units I.E., VII.B., and
XVII.B. (Refs. 4 and 127).
B. Paperwork Reduction Act (PRA)
The information collection requirements in this proposed rule have
been submitted for approval to the Office of Management and Budget
(OMB) under the Paperwork Reduction Act, 44 U.S.C. 3501 et seq. The
Information Collection Request (ICR) document prepared by the EPA has
been assigned the EPA ICR number 2556.01. You can find a copy of the
ICR in the docket for this proposed rule (Ref. 123), and it is briefly
summarized here.
Under the proposed approach for methylene chloride and both co-
proposed approaches for NMP, the information collection activities
required under the proposed rule include a downstream notification
requirement and a recordkeeping requirement. The downstream
notification would require companies that ship methylene chloride or
NMP to notify companies downstream in the supply chain of the
prohibitions of methylene chloride or NMP in the proposed rule. The
proposed rule does not require the regulated entities to submit
information to EPA. The proposed rule also does not require
confidential or sensitive information to be submitted to EPA or
downstream companies. The recordkeeping requirement mandates companies
that ship methylene chloride or NMP to retain certain information at
the company headquarters for three years from the date of shipment.
These information collection activities are necessary in order to
enhance the prohibitions under the proposed rule by ensuring awareness
of the prohibitions throughout the methylene chloride or NMP supply
chain, and to provide EPA with information upon inspection of companies
downstream who purchased methylene chloride or NMP. EPA believes that
these information collection activities would not significantly impact
the regulated entities.
Under the second co-proposed approach for NMP, processors of paint
and coating removal products containing NMP must test gloves for
permeability for each formulation they process. One type of gloves may
not be appropriate for all NMP paint remover formulations because the
permeability of the product will vary based on the other solvents and
chemicals used in the formulation. The testing requirements for glove
permeability and the labeling requirements mandate that processors
paint removers containing perform glove permeability testing on each
paint remover product containing NMP and update their current product
labels to contain warnings and instructions for consumers on how to
reduce exposures to NMP. Without the reporting requirements, processors
of these products might not provide information about the specific
types of protective gloves to users. Requiring that labels of paint and
coating removal products containing NMP include information about which
specific types of gloves provide dermal protection from the specific
product formulation provides information that is essential for knowing
how to reduce exposures while carrying out paint and coating removal
with NMP. Requiring additional warnings and instructions to consumers
provides information about the risks presented by the product and how
those risks can be reduced. EPA believes that these information
collection activities would not significantly impact the regulated
entities.
Respondents/Affected Entities: Methylene chloride and NMP
manufacturers, processors, and distributors; commercial users of NMP
for paint and coating removal.
Respondent's Obligation to Respond: Respondents are not obligated
to respond or report to EPA.
Estimated Number of Respondents for the Proposed Approach for
Methylene Chloride and the First Co-Proposed Approach for NMP: 327.
Estimated Total Number of Potential Respondents for the Proposed
Approach for Methylene Chloride and the Second Co-Proposed Approach for
NMP: 327
Frequency of Response: On occasion to third parties as needed.
Total Estimated Burden for the Proposed Approach for Methylene
Chloride and the First Co-Proposed Approach for NMP: 163.5
Estimated Total Annual Burden for the Proposed Approach for
Methylene Chloride and the Second Co-Proposed Approach for NMP: 1,084
hours.
Total Estimated Cost for the Proposed Approach for Methylene
Chloride and the First Co-Proposed Approach for NMP: $7,904 (per year).
Estimated Total Annual Costs for the Proposed Approach for
Methylene Chloride and the Second Co-Proposed Approach for NMP:
$924,890 (per year).
An agency may not conduct or sponsor, and a person is not required
to respond to a collection of information unless it displays a
currently valid OMB control number. The OMB control numbers for the
EPA's regulations in 40 CFR are listed in 40 CFR part 9.
Submit your comments on the Agency's need for this information, the
accuracy of the provided burden estimates, and any suggested methods
for minimizing respondent burden to EPA using the docket identified at
the beginning of this proposed rule. You may also send your ICR-related
comments to OMB's Office of Information and Regulatory Affairs via
email to [email protected], Attention: Desk Officer for the
EPA. Since OMB is required to make a decision concerning the ICR
between 30 and 60 days after receipt, OMB must receive comments no
later than February 21, 2017. The EPA will respond to any ICR-related
comments in the final rule.
C. Regulatory Flexibility Act (RFA)
Pursuant to section 603 of the RFA, 5 U.S.C. 601 et seq., EPA
prepared an initial regulatory flexibility analysis (IRFA) (Ref. 26)
that examines the impact of the proposed rule on small entities along
with regulatory alternatives that could minimize that impact. The
complete IRFA is available for review in the docket and is summarized
here.
1. Need for the rule. Under TSCA section 6(a) (15 U.S.C. 2605(a)),
if EPA
[[Page 7526]]
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 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. Based on EPA's risk
assessments of methylene chloride (Ref. 2) and NMP (Ref. 3), EPA
proposes a determination that the use of methylene chloride and NMP in
paint and coating removal presents an unreasonable risk of injury to
human health. The provisions of this proposal are necessary to address
the risk so that it is no longer unreasonable.
2. Objectives and legal basis. In part, the legal basis for this
proposal is TSCA section 6(a), which provides authority for the
Administrator to apply requirements to the extent necessary so that a
chemical substance or mixture no longer presents an unreasonable risk
of injury to health or the environment. Additional legal basis for the
proposal is found at TSCA section 26(l)(4). With respect to chemical
substances such as methylene chloride and NMP (which are listed in the
2014 update to the TSCA Work Plan for Chemical Assessments and for
which completed risk assessments were published prior to the date of
enactment of the Frank R. Lautenberg Chemical Safety for the 21st
Century Act) TSCA section 26(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.
3. Small entities covered by this proposal. EPA estimates that the
proposal would affect approximately 10,300 small entities. The majority
of these entities are commercial users of methylene chloride or NMP in
paint and coating removal in a variety of occupational settings such as
bathtub refinishing, graffiti removal, autobody repair, and residential
renovations. This also includes a small number of formulators of paint
and coating removal products that contain methylene chloride and NMP,
for commercial or consumer uses (Refs. 4, 26, and 127).
4. Compliance requirements and the professional skills needed. For
methylene chloride, EPA is proposing under TSCA section 6 to prohibit
the manufacture (including import), processing, and distribution in
commerce of methylene chloride for all consumer and many types or uses
of commercial paint and coating removal, as described in the proposed
rule. EPA is also proposing under TSCA section 6 to prohibit the use of
methylene chloride for commercial paint and coating removal in these
several specified sectors. Additionally, EPA is proposing to require
that any paint or coating removal products containing methylene
chloride that continue to be distributed be packaged in volumes no less
than 55-gallon containers, except for formulations produced
specifically for DOD. 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.
For NMP, EPA is co-proposing two approaches. Under the first co-
proposed approach, 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, exempting uses
identified in the proposed rule as critical to national security; and
to prohibit the commercial use of NMP for paint and coating removal,
exempting uses identified as critical to national security. EPA is
proposing to require that any paint or coating removal products
containing NMP that continue to be distributed be packaged in no less
than 5-gallon containers. 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. For the second co-proposed approach for
NMP, commercial users would be required to implement and maintain a
detailed program for worker protection, including dermal and
respiratory protection. Additionally, product processors would be
required to carry out testing to identify gloves that are protective
against each product formulation, labeling product with that
information, and provide additional information on the label to
consumers regarding risks of using the product and instructions on how
to reduce those risks. As in the first co-proposal, 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. More details on these two
co-proposals are in Unit XVI.B.3.
Under the proposed approach for methylene chloride and first co-
proposed approach for NMP, complying with the prohibitions, the
downstream notification, and the recordkeeping requirements involve no
special skills. However, implementing the use of substitute chemicals
or alternative paint and coating removal processes may involve special
skills or expertise in the sector in which the paint and coating
removal is conducted.
For the second co-proposed approach for NMP, commercial users would
be required to implement and maintain a detailed program for worker
protection, which would involve special skills or expertise in
industrial hygiene. Similarly, product processors would be required to
carry out testing to identify gloves that are protective against each
product formulation, could involve special skills or expertise.
Labeling products to comply with new requirements would not involve
special skill, particularly since EPA proposes to identify specific
information for labels of paint and coating removal products containing
NMP. As in the first co-proposal for NMP, the downstream notification
and the recordkeeping requirements require no special skills.
5. Other Federal regulations. Other Federal regulations that affect
the use of methylene chloride or NMP in paint and coating removal are
discussed in Units III.A. and XIII.A. While many of the statutes that
EPA and other agencies are charged with administering provide statutory
authority to address specific sources and routes of methylene chloride
exposure, none of these can address the serious human health risks from
methylene chloride exposure that EPA is proposing to address under TSCA
section 6(a). Regarding methylene chloride, because the methylene
chloride NESHAPs were developed only to regulate emissions from certain
types of paint and coating removal operations, not to address worker or
consumer exposures, they are not duplicative with this proposal.
Similarly, regulations addressing methylene chloride disposal or water
contamination do not address worker or consumer exposures when
conducting paint and coating removal. This proposed rule does not
conflict with the NESHAP (or regulations addressing methylene chloride
disposal or water contamination): it neither prohibits any action
required by such
[[Page 7527]]
rules, nor requires any action prohibited by such rules.
OSHA's methylene chloride standard, 29 CFR 1910.1052, was issued in
1997 and applies to general industry, construction, and shipyard
employment. This proposal does not duplicate OSHA's methylene chloride
standard. Nor does the proposed rule conflict with the OSHA standard:
it would not prohibit actions required to meet OSHA's methylene
chloride standard and it would not require actions in violation OSHA's
methylene chloride standard.
CPSC requires that consumer products that contain methylene
chloride be labeled with a statement regarding the cancer risks
presented by inhalation of methylene chloride fumes. This proposal does
not impose requirements that would duplicate or conflict with CPSC's
labeling requirements for methylene chloride.
Regarding NMP, there are no OSHA or CPSC regulations. EPA's
proposal is not duplicative of other Federal rules nor does it conflict
with other Federal rules.
6. Regulatory alternatives considered. As described in Units V.C.,
VI.C., XV.C., and XVI.B., EPA considered a wide variety of risk
reduction options. The Economic Analysis (Ref. 4) examined several
alternative analytical options. However, most of the alternatives did
not address the risks presented by methylene chloride and NMP in paint
and coating removal as necessary so that they would no longer be
unreasonable, either to the general population or (in the case of NMP)
to women of childbearing age.
The primary alternative considered by EPA for methylene chloride in
paint and coating removal was to allow the commercial use of methylene
chloride in paint and coating removal and require a respiratory
protection program, including PPE, air monitoring, and either a
supplied-air respirator of APF 1,000 or 10,000 or an air exposure limit
achieved through engineering controls or ventilation in commercial
facilities where methylene chloride is used for paint and coating
removal. Depending on air concentrations and proximity to the paint and
coating removal, other employees in the area would also need to wear
respiratory protection equipment. While this option would address the
risks presented by methylene chloride in paint and coating removal, so
that they would no longer be unreasonable, the Economic Analysis
indicates that this option is more expensive than switching to a
substitute chemical or alternative paint and coating removal method
(Ref. 4). However, as recommended by the SBAR panel, EPA is seeking
comment on and additional information about air monitoring and the use
of supplied-air respirators in firms conducting paint and coating
removal with methylene chloride (Ref. 27).
EPA is co-proposing two approaches to address risks presented by
NMP in commercial and consumer paint and coating removal. Those
approaches are described above. EPA considers both of these approaches
to be primary regulatory alternatives.
As required by section 609(b) of the RFA, EPA also convened a SBAR
Panel to obtain advice and recommendations from small entity
representatives that potentially would be subject to the rule's
requirements. The SBAR Panel evaluated the assembled materials and
small-entity comments on issues related to elements of an IRFA. A copy
of the full SBAR Panel Report (Ref. 27) is available in the rulemaking
docket.
The Panel recommended that EPA seek additional information in five
specific areas: Exposure information, regulatory options, alternatives,
cost information, and risk assessment. Specifically, the Panel
recommendations were: (1) Exposure information: EPA should request
workplace monitoring information during the comment period for worker
exposure levels from companies for methylene chloride and NMP in paint
and coating removal. EPA should request additional information
regarding the frequency of use currently of PPE, and consider that
information when weighing alternative options in the proposed
rulemaking for methylene chloride and NMP in paint and coating removal.
(2) Regulatory options: EPA should consider and seek public comments on
enhanced labeling requirements for consumer paint removal products
containing methylene chloride or NMP to reduce exposure to methylene
chloride and NMP. EPA should consider and seek public comments on a
control option such as a certification program similar to the Lead
Renovation, Repair and Painting program with increased training and
education for commercial users of paint removers. EPA should delay any
proposed regulatory action on methylene chloride for the commercial
furniture refinishing industry while it gathers additional information
to characterize the impacts on this industry of restrictions on use of
methylene chloride in paint and coating removal. EPA should request
comment on current practices in the furniture refinishing industry on
limiting exposure to methylene chloride used in paint and coating
removal. EPA should request comment on the feasibility of methylene
chloride only being sold in 30-55- gallon drums. EPA should address the
proposed regulatory actions as distinctly as possible in the one
proposed rulemaking addressing both methylene chloride and NMP in paint
and coating removal. (3) Alternatives: EPA should ensure that its
analysis of the available alternatives to methylene chloride and NMP in
paint and coating removal comply with the requirements of TSCA section
6(c)(2)(C) and include consideration, to the extent legally permissible
and practicable, of whether technically and economically feasible
alternatives that benefit health or the environment, compared to the
use being prohibited or restricted, will be reasonably available as a
substitute when the proposed requirements would take effect.
Specifically, EPA should evaluate the feasibility of using
alternatives, including the cost, relative safety, and other barriers;
and take into consideration the current and future planned regulation
of compounds the agency has listed as alternatives. (4) Cost
information: EPA should request additional information on the cost to
achieve reduced exposures in the workplace or to transition to
alternative chemicals or technologies. (5) Risk assessments: EPA should
recognize the concerns that the SERs had on the risk assessments by
referring readers to the risk assessments and the Agency's Summary of
External Peer Review and Public Comments and Disposition document for
each risk assessment, which addresses those concerns, in the preamble
of the proposed rulemaking.
Throughout this preamble, EPA has requested information with
respect to these and other topics.
D. Unfunded Mandates Reform Act (UMRA)
This action does not contain an unfunded mandate of $100 million or
more as described in UMRA, 2 U.S.C. 1531-1538, and does not
significantly or uniquely affect small governments. The requirements of
this action would primarily affect manufacturers, processors, and
distributors of methylene chloride or NMP. The total estimated
annualized cost of the proposed rule under the first co-proposed
approach for NMP is $4,185,000 to $23,423,000 and $4,550,000 to
$23,472,000 annualized over 20 years at 3% and 7%, respectively (Ref.
4). The total estimated annualized cost of the proposed rule under the
second co-proposed approach for NMP is $114,196,000 to $125,893,000 and
$114,658,000 to $125,438,000 annualized over 20 years
[[Page 7528]]
at 3% and 7%, respectively (Ref. 127), which does not exceed the
inflation-adjusted unfunded mandate threshold of $154 million.
E. Executive Order 13132: Federalism
The EPA has concluded that this action has federalism implications,
as specified in Executive Order 13132 (64 FR 43255, August 10, 1999),
because regulation under TSCA section 6(a) may preempt state law. EPA
provides the following federalism summary impact statement. The Agency
consulted with state and local officials early in the process of
developing the proposed action to permit them to have meaningful and
timely input into its development. EPA invited the following national
organizations representing state and local elected officials to a
meeting on May 13, 2015, in Washington DC: National Governors
Association; National Conference of State Legislatures, Council of
State Governments, National League of Cities, U.S. Conference of
Mayors, National Association of Counties, International City/County
Management Association, National Association of Towns and Townships,
County Executives of America, and Environmental Council of States. A
summary of the meeting with these organizations, including the views
that they expressed, is available in the docket (Ref. 124). Although
EPA provided these organizations an opportunity to provide follow-up
comments in writing, EPA received no written follow-up.
F. Executive Order 13175: Consultation and Coordination With Indian
Tribal Governments
This action does not have tribal implications, as specified in
Executive Order 13175 (65 FR 67249, November 9, 2000). This rulemaking
would not have substantial direct effects on tribal government because
methylene chloride or NMP are not manufactured, processed, or
distributed in commerce by tribes. Tribes do not regulate methylene
chloride or NMP, and this rulemaking would not impose substantial
direct compliance costs on tribal governments. Thus, EO 13175 does not
apply to this action. EPA nevertheless consulted with tribal officials
during the development of this action, consistent with the EPA Policy
on Consultation and Coordination with Indian Tribes.
EPA met with tribal officials in a national informational webinar
held on May 12, 2015 concerning the prospective regulation of methylene
chloride and NMP in paint and coating removal under TSCA section 6, and
in another teleconference with tribal officials on May 27, 2015 (Ref.
125). EPA also met with the National Tribal Toxics Council (NTTC) in
Washington, DC and via teleconference on April 22, 2015 (Ref. 125). In
those meetings, EPA provided background information on the proposed
rule and a summary of issues EPA explored. These officials expressed
support for EPA regulation to reduce the risks presented by methylene
chloride and NMP in paint and coating removal.
G. Executive Order 13045: Protection of Children From Environmental
Health Risks and Safety Risks
This action is subject to Executive Order 13045 because it is an
economically significant regulatory action as defined by Executive
Order 12866, and the EPA believes that the environmental health or
safety risk addressed by this action has a disproportionate effect on
children, specifically on the developing fetus. Accordingly, we have
evaluated the environmental health or safety effects of methylene
chloride and NMP in paint and coating removal on children. This
action's health and risk assessment of exposure by children to
methylene chloride and NMP in paint and coating removal are contained
in Units I.F., VI.C.1.c., and XVI.B.1.c. of this preamble. Supporting
information on methylene chloride and NMP exposures and the health
effects of methylene chloride or NMP exposure by children is available
in the Toxicological Review of Methylene Chloride (Ref. 5), the NMP
risk assessment (Ref. 3), and the methylene chloride risk assessment
(Ref. 2).
H. Executive Order 13211: Actions Concerning Regulations That
Significantly Affect Energy Supply, Distribution in Commerce, or Use
This proposed rule is not subject to Executive Order 13211 (66 FR
28355, May 22, 2001), because this action is not expected to affect
energy supply, distribution in commerce, or use. This rulemaking is
intended to protect against risks from methylene chloride and NMP in
paint and coating removal, and does not affect the use of oil, coal, or
electricity.
I. National Technology Transfer and Advancement Act (NTTAA)
This proposed rulemaking does not involve technical standards, and
is therefore not subject to considerations under NTTAA section 12(d),
15 U.S.C. 272 note. However, under one of the co-proposals for NMP
discussed in Unit XVI, EPA is proposing to require processors of paint
and coating removal products that contain NMP to identify, through
testing, gloves that provide an impervious barrier to dermal exposure
during normal and expected duration and conditions of exposure. EPA has
identified two potentially-applicable voluntary consensus standards for
this process: ASTM International Standard F739, ``Standard Test Method
for Permeation of Liquids and Gases through Protective Clothing
Materials under Conditions of Continuous Contact,'' and ASTM
International F1194-99, ``Standard Guide for Documenting the Results of
Chemical Permeation Testing of Materials Used in Protective Clothing
Materials.'' EPA is not proposing specific provisions for conducting
and documenting glove testing, nor is EPA proposing to incorporate
these voluntary consensus standards by reference. EPA requests comment
on whether the regulation should include additional requirements on
glove testing for processors and, if so, how that should be
accomplished.
J. Executive Order 12898: Federal Actions To Address Environmental
Justice in Minority Populations and Low-Income Populations
Executive Order 12898 (59 FR 7629, February 16, 1994) establishes
federal executive policy on environmental justice. Its main provision
directs federal agencies, to the greatest extent practicable and
permitted by law, to make environmental justice part of their mission
by identifying and addressing, as appropriate, disproportionately high
and adverse health or environmental effects of their programs, policies
and activities on minority populations and low-income populations in
the U.S. Units VI.C.1.b.,VI.D.10., XVI.B.1.b., and XVI.C.6. of this
preamble address public health impacts from methylene chloride and NMP
in paint and coating removal. This proposed rule would address the
current disproportionate risk to Hispanic workers (of all races) and
foreign-born workers in the construction trades, where these two
populations are overrepresented compared to the general U.S. adult
population (Ref. 4). Though this proposed rule would eliminate risks of
exposure to NMP and methylene chloride when used in paint and coating
removal in the construction trades, because workers in these two
populations currently are overrepresented in this trade, these
populations would disproportionately benefit from this risk reduction.
The EPA places particular emphasis on the public health and
environmental conditions affecting minority populations, low-income
populations,
[[Page 7529]]
and indigenous peoples. In recognizing that these populations
frequently bear a disproportionate burden of environmental harms and
risks, EPA works to protect them from adverse public health and
environmental effects (Ref. 126).
List of Subjects in 40 CFR Part 751
Environmental protection, Chemicals, Export notification, Hazardous
substances, Import certification, Recordkeeping.
Dated: January 12, 2017.
Gina McCarthy,
Administrator.
Therefore, 40 CFR part 751, as proposed to be added at 81 FR 91592
(December 16, 2016), is proposed to be further amended as follows:
PART 751--REGULATION OF CERTAIN CHEMICAL SUBSTANCES AND MIXTURES
UNDER SECTION 6 OF THE TOXIC SUBSTANCES CONTROL ACT
0
1. The authority citation for part 751 is revised to read as follows:
Authority: 15 U.S.C. 2605, 15 U.S.C. 2625(l)(4).
0
2. Add Subpart B to read as follows:
Subpart B--Methylene Chloride
Sec.
751.101 General.
751.103 Definitions.
751.105 Consumer Paint and Coating Removal.
751.107 Commercial Paint and Coating Removal in Specified Industries
or for Specified Uses.
751.109 Downstream Notification.
751.111 Recordkeeping.
Subpart B--Methylene Chloride
Sec. 751.101 General.
This subpart sets certain restrictions on the manufacture
(including import), processing, distribution in commerce, and uses of
methylene chloride (CASRN 75-09-2) to prevent unreasonable risks to
health associated with human exposure to methylene chloride for the
specified uses.
Sec. 751.103 Definitions.
The definitions in subpart A of this part apply to this subpart
unless otherwise specified in this section. In addition, the following
definitions apply:
Commercial furniture stripping means furniture stripping conducted
in a commercial facility performed by an individual, government entity,
or company for which an individual, government entity, or company
receives remuneration or other form of payment.
Commercial paint and coating removal means paint and coating
removal performed by an individual, government entity, or company, for
which an individual, government entity, or company receives
remuneration or other form of payment.
Critical corrosion-sensitive components of military aviation and
vessels means parts that directly enable or support warfighting assets
of the Department of Defense (DOD) and include ``safety critical
items'' identified by DOD in accordance with DOD policies and
requirements for ensuring safety and performance. These include
corrosion-sensitive aviation and vessel safety-critical components such
as landing gear, gear boxes, turbine engine parts, and other military
aircraft and vessel components composed of metallic materials
(specifically high-strength steel, aluminum, titanium, and magnesium)
and composite materials that not only require their coatings be removed
for inspection and maintenance but also would be so negatively affected
by the use of paint removal chemicals or methods other than methylene
chloride that the safety of the system could be compromised.
Distribute in commerce has the same meaning as in section 3 of the
Act, except that the term does not include retailers for purposes of
Sec. 751.109 and Sec. 751.111.
Furniture stripping means paint and coating removal from furniture
and includes application of a chemical or use of another method to
remove, loosen, or deteriorate any paint, varnish, lacquer, graffiti,
surface protectants, or other coating from wood, metal, or other types
of furniture, doors, radiators, or cabinets. Furniture stripping
includes paint and coating removal from furniture that occurs
separately from or as part of furniture refinishing.
Paint and coating removal means application of a chemical or use of
another method to remove, loosen, or deteriorate any paint, varnish,
lacquer, graffiti, surface protectants, or other coating from a
substrate, including objects, vehicles, architectural features, or
structures.
Retailer means a person or business who distributes in commerce a
chemical substance, mixture, or article to consumer end users.
Sec. 751.105 Consumer Paint and Coating Removal.
After [date 180 calendar days after the date of publication of the
final rule], all persons are prohibited from manufacturing, processing,
and distributing in commerce methylene chloride for consumer paint and
coating removal.
Sec. 751.107 Commercial Paint and Coating Removal in Specified
Industries or for Specified Uses.
(a) After [date 180 calendar days after the date of publication of
the final rule], all persons are prohibited from manufacturing,
processing, and distributing in commerce methylene chloride for
commercial paint and coating removal except for commercial furniture
stripping or for paint and coating removal from critical corrosion-
sensitive components of military aviation and vessels as defined in
Sec. 751.103. After [date 10 years after the date of publication of
the final rule], all persons are prohibited from manufacturing,
processing, and distributing in commerce methylene chloride for paint
and coating removal from critical corrosion-sensitive components of
military aviation and vessels.
(b) After [date 180 calendar days after the date of publication of
the final rule], all persons are prohibited from distributing in
commerce methylene chloride for paint and coating removal in containers
with a volume less than 55 gallons except for formulations specifically
manufactured for the Department of Defense, which may be distributed in
commerce in containers with a volume no less than 5 gallons.
(c) After [date 270 calendar days after the date of publication of
the final rule], all persons are prohibited from commercial use of
methylene chloride for paint and coating removal except for commercial
furniture stripping or for paint and coating removal from critical
corrosion-sensitive components of military aviation and vessels as
defined in Sec. 751.103. After [date 10 years after the date of
publication of the final rule], all persons are prohibited from
commercial use of methylene chloride for paint and coating removal from
critical corrosion-sensitive components of military aviation and
vessels.
(d) Any paint and coating removal from critical corrosion-sensitive
components of military aviation and vessels must be conducted under the
following restrictions:
(1) All paint and coating removal from critical corrosion-sensitive
components of military aviation and vessels using methylene chloride
must be conducted at DOD installations, or at deployed locations under
the control of DOD organizations, or at locations of DOD contractors
performing coating removal work from corrosion-sensitive components of
military aviation and vessels for DOD.
[[Page 7530]]
Sec. 751.109 Downstream Notification.
Each person who manufactures, processes, or distributes in commerce
methylene chloride for any use after [date 45 calendar days after the
date of publication of the final rule] must, prior to or concurrent
with the shipment, notify companies to whom methylene chloride is
shipped, in writing, of the restrictions described in this subpart.
Sec. 751.111 Recordkeeping.
(a) Each person who manufactures, processes, or distributes in
commerce any methylene chloride after [date 45 calendar days after the
date of publication of final rule] must retain in one location at the
headquarters of the company documentation showing:
(1) The name, address, contact, and telephone number of companies
to whom methylene chloride was shipped;
(2) A copy of the notification provided under Sec. 751.109; and
(3) The amount of methylene chloride shipped.
(b) The documentation in (a) must be retained for 3 years from the
date of shipment.
0
3. Add Subpart C as follows:
Subpart C--N-Methylpyrrolidone.
Sec.
751.201 General.
751.203 Definitions. [option 1]
751.205 Manufacture, processing, and distribution of NMP for
consumer paint and coating removal.
751.207 Manufacture, Processing, and Distribution of NMP for
Commercial Paint and Coating Removal
751.209 Downstream Notification.
751.211 Recordkeeping. [option 2]
751.205 Paint and Coating Removal for Specified Uses.
751.209 Downstream Notification.
751.211 Recordkeeping.
Subpart C--N-Methylpyrrolidone
Sec. 751.201 General.
This subpart sets certain restrictions on the manufacture
(including import), processing, distribution in commerce, and uses of
N-methylpyrrolidone (NMP) (CASRN 872-50-4) to prevent unreasonable
risks to health associated with human exposure to NMP for the specified
uses.
Sec. 751.203 Definitions.
The definitions in subpart A of this part apply to this subpart
unless otherwise specified in this section. In addition, the following
definitions apply:
Commercial paint and coating removal means paint and coating
removal performed by an individual, government entity, or company, for
which an individual, government entity, or company receives
remuneration or other form of payment.
Critical corrosion-sensitive components of military aviation and
vessels means parts that directly enable or support warfighting assets
of the Department of Defense (DOD) and include ``safety critical
items'' identified by DOD in accordance with DOD policies and
requirements for ensuring safety and performance. These include
corrosion-sensitive aviation and vessel safety-critical components such
as landing gear, gear boxes, turbine engine parts, and other military
aircraft and vessel components composed of metallic materials
(specifically high-strength steel, aluminum, titanium, and magnesium)
and composite materials that not only require their coatings be removed
for inspection and maintenance but also would be so negatively affected
by the use of paint removal chemicals or methods other than NMP that
the safety of the system could be compromised.
Distribute in commerce has the same meaning as in section 3 of the
Act, except that the term does not include retailers for purposes of
Sec. 751.209 and Sec. 751.211.
Formulation is a mixture of active and other ingredients.
Paint and coating removal means application of a chemical or other
method to remove, loosen, or deteriorate any paint, varnish, lacquer,
graffiti, surface protectants, or other coatings from a substrate,
including objects, vehicles, architectural features, or structures.
Retailer means a person or business who distributes in commerce a
chemical substance, mixture, or article to consumer end users.
[OPTION 1 PROPOSED REGULATORY TEXT FOR Sec. Sec. 751.205, 751.207,
751.209, and 751.211: Co-Proposal 1: NMP--Banning the Manufacture,
Processing, Distribution, and Use Except for a Critical Use Exemption]
Sec. 751.205 Manufacture, Processing, and Distribution of NMP for
Consumer Paint and Coating Removal.
After [date 180 calendar days after the date of publication of the
final rule], all persons are prohibited from manufacturing, processing,
and distributing in commerce NMP for consumer paint and coating
removal.
Sec. 751.207 Manufacture, Processing, and Distribution of NMP for
Commercial Paint and Coating Removal.
(a) After [date 180 calendar days after the date of publication of
the final rule], all persons are prohibited from manufacturing,
processing, and distributing in commerce NMP for commercial paint and
coating removal except for paint and coating removal from critical
corrosion-sensitive components of military aviation and vessels as
defined in Sec. 751.203. After [date 10 years after the date of
publication of the final rule], all persons are prohibited from
manufacturing, processing, and distributing in commerce NMP for paint
and coating removal from critical corrosion-sensitive components of
military aviation and vessels.
(b) After [date 180 calendar days after the date of publication of
the final rule], all persons are prohibited from distributing in
commerce NMP for paint and coating removal in containers with a volume
less than 55 gallons except for formulations specifically manufactured
for the Department of Defense, which may be distributed in commerce in
containers with a volume no less than 5 gallons.
(c) After [date 270 calendar days after the date of publication of
the final rule], all persons are prohibited from commercial use of NMP
for paint and coating removal except for paint and coating removal from
critical corrosion-sensitive components of military aviation and
vessels as defined in Sec. 751.203. After [date 10 years after the
date of publication of the final rule], all persons are prohibited from
commercial use of NMP for paint and coating removal from critical
corrosion-sensitive components of military aviation and vessels.
(d) Any paint and coating removal from critical corrosion-sensitive
components of military aviation and vessels must be conducted under the
following restrictions:
(1) All paint and coating removal from critical corrosion-sensitive
components of military aviation and vessels using NMP must be conducted
at DOD installations; DOD owned, contractor operated locations; or
contractor owned, contractor operated locations performing paint and
coating removal from critical corrosion-sensitive components of
military aviation and vessels for DOD.
(2) [Reserved].
Sec. 751.209 Downstream notification.
Each person who manufactures, processes, or distributes in commerce
NMP for any use after [date 45 calendar days after the date of
publication of the final rule] must, prior to or concurrent with the
shipment, notify companies to whom NMP is shipped, in writing, of the
restrictions described in this subpart.
[[Page 7531]]
Sec. 751.211 Recordkeeping.
(a) Each person who manufactures, processes, or distributes in
commerce any NMP after [date 45 calendar days after the date of
publication of final rule] must retain in one location at the
headquarters of the company documentation showing:
(1) The name, address, contact, and telephone number of companies
to whom NMP was shipped;
(2) A copy of the notification provided under Sec. 751.209; and
(3) The amount of NMP shipped.
(b) The documentation in (a) must be retained for 3 years from the
date of shipment.
[OPTION 2 PROPOSED REGULATORY TEXT FOR Sec. Sec. 751.205, 751.209, and
751.211: Co-Proposal 2: NMP--Continued Use with Requirements for
Product Reformulation, Labeling, and PPE]
Sec. 751.205 Paint and Coating Removal for Specified Uses.
(a) Processors. (1) Formulations of NMP for paint and coating
removal that contain more than 35 percent by weight of NMP must not be
manufactured, processed, or distributed in commerce after [date 180
calendar days after the date of publication of the final rule], except
for product formulations destined to be used by DOD or contractors
performing work only on DOD projects for paint and coating removal from
critical corrosion-sensitive components of military aviation and
vessels as defined in Sec. 751.203 and subsection (b)(1).
(2) Conduct glove testing for each separate formulation of NMP,
with a variation of more than 1 percent in any component of a paint and
coating removal product containing NMP considered a separate
formulation.
(i) The processor must be able to demonstrate that the gloves
provide an impervious barrier to prevent dermal exposure during normal
and expected duration and conditions of exposure.
(ii) The processor must subject the gloves to the expected
conditions of exposure, including the likely combinations of chemical
substances to which the gloves may be exposed in the work area.
(3) Provide a label securely attached to each NMP paint and coating
removal product and not in the form of a booklet or other pull off type
labeling. Label information must be prominently displayed and in an
easily readable font size. Each separate NMP paint and coating removal
product must be labeled with the following information:
(i) A notice that 40 CFR 751.205 requires commercial users of NMP
paint and coating removal products to establish an occupational dermal
and respiratory protection program, including the use of specialized
gloves and an air exposure limit or respirator.
(ii) A warning to consumers that fetal death and other irreversible
health effects may occur as a result of using the NMP product;
(iii) An identification of the formulation-specific gloves that
will provide protection from the NMP product and a direction to use a
new pair of those gloves for each time the NMP product is used;
(iv) A direction for consumers to either use the product outdoors
or adequately ventilate the workspace by opening windows and adding
fans;
(v) A warning for consumers to not apply the product as a spray;
(vi) A direction to wear clothing that covers exposed skin;
(vii) A direction to use a respirator with an Assigned Protection
Factor (APF) of 10. Refer to Sec. 751.205(c)(3)(ii) for respirators
having an APF of 10 or greater;
(b) Commercial users. Each person or company engaged in any
commercial NMP paint and coating removal activities [date 180 calendar
days after the date of publication of the final rule] is prohibited
from using paint and coating removal products or formulations that
contain more than 35 percent by weight of NMP and must institute a
worker protection program that includes the requirements of Sec.
751.205(c) and (e) except for product formulations destined to be used
for paint and coating removal from critical corrosion-sensitive
components of military aviation and vessels as defined in Sec.
751.203. After [date 10 years after the date of publication of the
final rule], all persons are prohibited from using paint and coating
removal products or formulations that contain more than 35 percent by
weight of NMP and must institute a worker protection program that
includes the requirements of Sec. 751.205(c) and (e).
(1) Any paint and coating removal from critical corrosion-sensitive
components of military aviation and vessels must be conducted under the
following restrictions:
(i) All paint and coating removal from critical corrosion-sensitive
components of military aviation and vessels using NMP must be conducted
at DOD installations; or at government owned, contractor operated
locations; or at contractor owned and contractor operated locations
performing paint and coating removal from critical corrosion-sensitive
components of military aviation and vessels for DOD.
(ii) [Reserved].
(2) [Reserved].
(c) Personal protective equipment (PPE).
(1) General. (i) Protective equipment that is of safe design and
construction for the work to be performed must be provided, used, and
maintained in a sanitary, reliable, and undamaged condition. The
employer must select PPE that properly fits each affected employee and
communicate PPE selections to each affected employee.
(ii) Training. The employer must provide training to each employee
required to use PPE.
(A) Each affected employee must be trained to know at least the
following:
(1) When PPE is necessary.
(2) What PPE is necessary.
(3) How to properly don, doff, adjust, and wear PPE.
(4) The limitations of the PPE.
(5) The proper care, maintenance, useful life and disposal of the
PPE.
(B) Each affected employee must demonstrate an understanding of
these elements and the ability to use PPE properly before being allowed
to perform work requiring the use of PPE.
(C) Retraining is required when previous training is rendered
obsolete, whether due to changes in the workplace or the type of PPE,
or when the employer has reason to believe that a previously-trained
employee does not have the understanding and skill required by this
subparagraph.
(2) Dermal protective equipment. (i) General. Each person who is
reasonably likely to be dermally exposed in the work area to an NMP
paint and coating removal product through direct handling of the
substance or through contact with equipment or materials on which the
substance may exist, or because the substance becomes airborne must be
provided with, and required to wear, personal protective equipment that
provides a barrier to prevent dermal exposure to the substance in the
specific work area where it is selected for use.
(ii) Specific dermal protective equipment. The required dermal
protective equipment includes, but is not limited to, the following
items:
(A) Formulation-specific gloves as indicated on the NMP paint and
coating removal product label. A new pair must be supplied and worn
each time the NMP product is used.
(B) Impervious clothing covering the exposed areas of the body
(e.g. long pants, long shirt).
(iii) Demonstration of imperviousness. The employer must
demonstrate that each item of chemical protective clothing selected
provides an impervious barrier to prevent dermal exposure during normal
and expected
[[Page 7532]]
duration and conditions of exposure within the work area by any one or
a combination of the following:
(A) Testing the material used to make the chemical protective
clothing and the construction of the clothing to establish that the
protective clothing will be impervious for the expected duration and
conditions of exposure. The testing must subject the chemical
protective clothing to the expected conditions of exposure, including
the likely combinations of chemical substances to which the clothing
may be exposed in the work area.
(B) Evaluating the specifications from the manufacturer or supplier
of the chemical protective clothing, or of the material used in
construction of the clothing, to establish that the chemical protective
clothing will be impervious to the chemical substance alone and in
likely combination with other chemical substances in the work area.
(3) Respiratory protection. (i) General. Each person who is
reasonably likely to be exposed in the workplace to the use of NMP in
paint and coating removal products must be provided with and is
required to wear, at a minimum, a NIOSH-certified respirator with an
APF of 10. All respirators must be issued, used, and maintained in
accordance with an appropriate written respiratory protection program
that is specific to the workplace and that includes the following:
(A) Procedures for selecting respirators for use in the workplace.
(B) Medical evaluations of employees required to use respirators.
(C) Fit testing procedures.
(D) Procedures for proper use of respirators.
(E) Procedures and schedules for cleaning, disinfecting, storing,
inspecting, repairing, discarding, and otherwise maintaining
respirators.
(F) Procedures to ensure adequate air quality, quantity, and flow
of breathing air for atmosphere-supplying respirators.
(G) Procedures for regularly evaluating the effectiveness of the
program.
(H) Recordkeeping.
(ii) Authorized respirators. The following NIOSH-certified
respirators meet the minimum requirements of this section:
(A) Any NIOSH-certified air-purifying elastomeric half-mask
respirator equipped with N100 (if oil aerosols absent), R100, or P100
filters;
(B) Any appropriate NIOSH-certified N100 (if oil aerosols absent),
R100, or P100 filtering facepiece respirator;
(C) Any NIOSH-certified air-purifying full facepiece respirator
equipped with N100 (if oil aerosols absent), R100, or P100 filters. A
full facepiece air-purifying respirator, although it has a higher APF
of 50, is required to provide full face protection because the PMN
substance presents significant exposure concern for mucous membranes,
eyes, or skin;
(D) Any NIOSH-certified negative pressure (demand) supplied-air
respirator equipped with a half-mask; or
(E) Any NIOSH-certified negative pressure (demand) self-contained
breathing apparatus (SCBA) equipped with a half mask.
(d) Alternative to respirator requirement. Commercial users of NMP
products for paint and coating removal may use an existing chemical
exposure limit (ECEL) as a means of controlling inhalation exposures
whenever practicable rather than respirators.
(1) Existing Chemical Exposure Limit (ECEL). The employer must
ensure that no person is exposed to an airborne concentration of NMP in
excess of 20 mg/m\3\ (the ECEL) as an 8-hour time-weighted average
(TWA) without using a respirator. For non-8-hour work-shifts, the ECEL
for that work-shift (ECELn) must be determined by the following
equation: ECELn = ECEL x (8/n) x [(24-n)/16], where n = the number of
hours in the actual work-shift.
(2) Verification of method validity. An independent accredited
reference laboratory must verify the validity of the analytical method
for NMP in paint and coating removal products. The sampling and
analytical method, and all exposure monitoring data relied on by the
employer, must be accurate to within 25% at a 95% confidence level for
concentrations of NMP ranging from one half the ECEL to twice the ECEL.
(3) Exposure monitoring. The employer must collect samples that are
representative of the potential exposure of each person who is
reasonably likely to be exposed to airborne concentrations of NMP.
(i) Initial monitoring. Before the employer may deviate from the
respirator requirements in subsection (d) of this section, the employer
must conduct initial exposure monitoring to accurately determine the
airborne concentration of NMP for each exposure group in which persons
are reasonably likely to be exposed.
(ii) Results. (A) Employees whose exposures are represented by
initial monitoring results below the ECEL need not wear the respirators
required in subsection (d) of this section.
(B) Employees whose exposures are represented by initial monitoring
results above the ECEL must continue to wear the respirators required
in subsection (d) of this section until such time as two monitoring
results below the ECEL, sampled at least 24 hours apart, are obtained.
(C) Within 15 days of the date exposure monitoring results are
received, the employer must provide the results to each person whose
exposure is represented by the monitoring. If the result is above the
ECEL, the employer must also provide the employee with information on
the actions the employer will take to reduce employee exposures to the
ECEL or below.
(iii) Periodic monitoring. The employer must repeat exposure
monitoring:
(A) Every 6 months for those employees whose initial monitoring
results are between 0.5 ECEL and the ECEL, until such time as 2 results
below 0.5 ECEL, from samples collected at least 24 hours apart, are
obtained,
(B) Every 3 months for those employees whose initial monitoring
results are at or above the ECEL. If 2 results below the ECEL, from
samples collected at least 24 hours apart, are obtained, then frequency
may be reduced to every 6 months. If 2 results below 0.5 ECEL, from
samples collected at least 24 hours apart, are obtained, then exposure
monitoring under this subsection need not be repeated unless there is a
process, equipment, environment, or personnel change.
(C) At any time when process, equipment, environment, or personnel
changes may reasonably cause new or additional exposures to NMP.
(e) Hazard communication program. Each employer that performs
commercial NMP paint and coating removal activities must develop and
implement a written hazard communication program for the substance in
each workplace. The written program will, at a minimum, describe how
the requirements of this section for labels, SDSs, other forms of
warning material, and employee information and training will be
satisfied. The employer must make the written hazard communication
program available, upon request, to all employees, contractor
employees, and their designated representatives. The employer may rely
on an existing hazard communication program that satisfies the
requirements of this paragraph.
(1) General. The written program must include the following:
(i) A list of each NMP paint and coating removal product present in
the work area. The list must be maintained in the work area and must
use the identity provided on the appropriate
[[Page 7533]]
SDS. The list may be compiled for the workplace or for individual work
areas.
(ii) The methods the employer will use to inform contractors of the
presence of NMP paint and coating removal products in the employer's
workplace and of the provisions of this part applicable to the NMP
products if employees of the contractor work in the employer's
workplace and are reasonably likely to be exposed to the NMP products
while in the employer's workplace.
(2) Employee information and training. Each employer must ensure
that employees are provided with information and training on NMP paint
and coating removal products. This information and training must be
provided at the time of each employee's initial assignment to using an
NMP paint and coating removal product.
(i) Information provided to employees under this paragraph must
include:
(A) The requirements of this section.
(B) The location and availability of the written hazard
communication program.
(ii) Training provided to employees must include:
(A) The potential human health hazards of the NMP paint and coating
removal products as specified on the label.
(B) The measures employees can take to protect themselves from the
NMP paint and coating removal products, including specific procedures
the employer has implemented to protect employees from exposure to the
substance, including appropriate work practices, emergency procedures,
personal protective equipment, engineering controls, and other measures
to control worker exposure.
(3) Existing hazard communication program. The employer need not
take additional actions if existing programs and procedures satisfy the
requirements of this section.
Sec. 751.209 Downstream notification.
Each person who manufactures, processes, or distributes in commerce
NMP for any use after [date 45 calendar days after the date of
publication of the final rule] must, prior to or concurrent with the
shipment, notify companies to whom NMP is shipped, in writing, of the
restrictions described in this subpart.
Sec. 751.211 Recordkeeping.
(a) Each person who manufactures, processes, or distributes in
commerce any NMP after [date 45 calendar days after the date of
publication of final rule] must retain in one location at the
headquarters of the company documentation showing:
(1) The name, address, contact, and telephone number of companies
to whom NMP was shipped;
(2) A copy of the notification provided under Sec. 751.209; and
(3) The amount of NMP shipped.
(b) The documentation in (a) must be retained for 3 years from the
date of shipment.
[FR Doc. 2017-01222 Filed 1-18-17; 8:45 am]
BILLING CODE 6560-50-P