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;

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

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

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

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

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

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

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

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

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

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

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).

    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

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

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

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.

    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.

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

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