Document ID: EPA-HQ-OPPT-2016-0231-0001
Agency: epa
Document Type: Proposed Rule
Title: Regulation of Certain Uses under Toxic Substances Control Act: Methylene Chloride and N-Methylpyrrolidone
Posted Date: 2017-01-19T05:00Z

[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: corado.ana@epa.gov. 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: kramek.niva@epa.gov.
    For general information contact: The TSCA-Hotline, ABVI-Goodwill, 
422 South Clinton Ave., Rochester, NY 14620; telephone number: (202) 
554-1404; email address: TSCA-Hotline@epa.gov.

SUPPLEMENTARY INFORMATION: 

I. Executive Summary

A. Does this action apply to me?

    You may potentially be affected by this 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

[[Page 7466]]

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

[[Page 7467]]

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

[[Page 7468]]

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

[[Page 7484]]

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).

[[Page 7485]]

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,

[[Page 7486]]

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

[[Page 7487]]

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

[[Page 7493]]

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

[[Page 7494]]

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

[[Page 7495]]

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

[[Page 7496]]

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

[[Page 7497]]

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;

[[Page 7498]]

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

[[Page 7502]]

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

[[Page 7503]]

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

[[Page 7504]]

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

[[Page 7505]]

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

[[Page 7506]]

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

[[Page 7507]]

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.
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115. Skogen, JC; Overland, S. ``The fetal origins of adult disease: 
a narrative review of the epidemiological literature.'' Journal of 
the Royal Society of Medicine. 2012, Vol 3. Bergen, Norway.
116. Centers for Disease Control and Prevention. ``The Health 
Effects of Overweight and Obesity.'' 2015. http://www.cdc.gov/healthyweight/effects/. Accessed May 17, 2016
117. American Heart Association. ``What is Metabolic Syndrome?'' 
Answers by Heart. 2015.
118. Hack, M.; Klein, NK; Taylor, HG. ``Long-term developmental 
outcomes of low birth weight infants.'' The Future of Children. 
Spring 1995, Vol 5(1), p 176-96.
119. EPA (US Environmental Protection Agency). 1991b. Guidelines for 
Developmental Toxicity Risk Assessment. EPA/600/FR-91/001. Risk 
Assessment Forum, Washington, DC. http://www.epa.gov/raf/publications/pdfs/DEVTOX.pdf.
120. ECHA (European Chemicals Agency). Annex XV Dossier. Proposal 
for Identification of a Substance as a Category 1a or 1b CMR, PBT, 
Vpvb or a Substance of an Equivalent Level of Concern, 1-Methyl-2-
Pyrrolidone. 2011. Helsinki, Finland.
121. United States Consumer Product Safety Commission (CPSC). Letter 
to James J. Jones from Patricia H. Adkins. April 19, 2016.
122. U.S. Department of Labor- Occupational Safety and Health 
Administration (OSHA). Letter to James J. Jones from David Michaels, 
Ph.D., MPH. March 31, 2016.
123. EPA. Supporting Statement for an Information Collection Request 
(ICR) Under the Paperwork Reduction Act (PRA). July 6, 2016.
124. EPA. Section 6(a) Rulemakings under the Toxic Substances 
Control Act (TSCA)

[[Page 7525]]

Paint Removers & TCE Rulemakings E.O. 13132: Federalism 
Consultation. May 13, 2015.
125. EPA. Notification of Consultation and Coordination on Proposed 
Rulemakings under the Toxic Substances Control Act for 1) Methylene 
Chloride and n-Methylpyrrolidone in Paint Removers and 2) 
Trichloroethylene in Certain Uses. April 8, 2015.
126. EPA. Paint Removers: Methylene Chloride and N-
Methylpyrrolidone--Community Webinar. May 28, 2015.
127. EPA. Economic Analysis of Second Co-Proposal for N-
Methylpyrrolidone. 2016.

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 oira_submission@omb.eop.gov, 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