United States
W Lai I Environmental Protection Agency
December 2020
Office of Chemical Safety and
Pollution Prevention
n-Methylpyrrolidone (2-Pyrrolidinone, 1-Methyl-)
(NMP) Final Risk Evaluation
Non-technical Summary
CASRN: 872-50-4
December 2020
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ACTION
• EPA is releasing the final risk evaluation on n-methylpyrrolidone (NMP). After evaluating 37
conditions of use of NMP, EPA has determined that NMP presents an unreasonable risk
under 26 conditions of use. This includes an unreasonable risk to workers when domestically
manufacturing or importing the chemical, processing the chemical for a variety of uses, and
when used in a variety of industrial and commercial conditions of use. This also includes an
unreasonable risk to consumers from one consumer use. NMP does not pose an unreasonable
risk under distribution in commerce or in a variety of industrial and commercial and
consumer applications. EPA also determined that NMP does not present an unreasonable risk
to the environment and general population.
• This final risk evaluation is conducted pursuant to the Toxic Substances Control Act (TSCA),
as amended by the Frank R. Lautenberg Chemical Safety for the 21st Century Act, which
requires EPA to prioritize and evaluate the safety of existing chemicals to determine whether
a chemical presents an unreasonable risk of injury to health or the environment under the
conditions of use. Under TSCA, if a chemical is determined to present an unreasonable risk,
then EPA must regulate the substance to address the unreasonable risk.
• The final risk evaluation and supplemental materials can be found in docket EPA-HQ-
OPPT-2019-0236 on www.regulations.gov.
• NMP was selected in 2016 as one of the first 10 chemicals for risk evaluation under section 6
of TSCA.
• Public comments and external scientific peer review informed the development of the NMP
final risk evaluation. EPA published the NMP draft risk evaluation in November 2019, the
NMP problem formulation document in June 2018, and the scope document in June 2017.
KEY POINTS
• After evaluating 37 conditions of use of NMP, EPA determined that NMP presents an
unreasonable risk under 26 conditions of use. This includes an unreasonable risk of injury to
health of workers during occupational exposures, and to consumers during one consumer use.
• These unreasonable risks of injury to health include developmental effects from acute
inhalation and dermal exposures, and reproductive effects from chronic inhalation and
dermal exposures.
• The conditions of use with unreasonable risks include domestic manufacturing and import;
processing as a reactant or intermediate or into a formulation, mixture or reaction product; in
articles; repackaging and recycling; a variety of industrial and commercial uses including as
a paint and coating additive and solvent for cleaning or degreasing, adhesives and sealants,
anti-freeze and de-icing products, metal products including hydrophilic coatings, lithium ion
battery manufacturing, laboratory chemicals, and cleaning and furniture care products;
and consumer use in adhesives and sealants.
• The conditions of use that EPA determined do not present an unreasonable
risk include distribution in commerce; industrial and commercial use in ink, toner, and
colorant products; soldering; fertilizer and other agricultural chemical manufacturing, and
consumer use in paint and coating removers; adhesive removers; lacquers, stains, varnishes,
primers and floor finishes; paint and coating additives; automotive care products; cleaning
and furniture care products; and lubricant and lubricant additives including hydrophilic
coatings.
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• EPA released the draft risk evaluation for NMP in November 2019 for a 60-day public
comment period. Additionally, EPA held a peer review meeting of the Science Advisory
Committee on Chemicals on the draft risk evaluation of NMP on December 5-6, 2019. The
report is in the TSCA Science Advisory Committee on Chemicals docket (EPA-HQ-OPPT-
2019-0236). Along with the final risk evaluation, EPA is releasing a document that provides
a response to public and peer review comments.
BACKGROUND
• NMP has a wide range of uses in industry and consumer and commercial products. NMP is
widely used as a solvent in the manufacture and production of electronics, petroleum
products, pharmaceuticals, polymers and other specialty chemicals. The total aggregate
production volume reported under the Chemical Data Reporting rule for the 2016 period
indicates over 160 million pounds of NMP were manufactured (including imports) in the
United States.
• In 2015, prior to amended TSCA, EPA published an NMP risk assessment that covered a
subset of uses with high potential for exposure to consumers and workers. This NMP risk
assessment identified non-cancer risks. The final risk evaluation assesses a much broader
range of conditions of use than the prior risk assessment.
• Evaluation and risk management steps for the NMP final risk evaluation:
o EPA has issued the final risk evaluation for NMP, meeting the requirements set forth
in TSCA section 6. EPA is now initiating the process to address the unreasonable
risks identified in the final risk evaluation. EPA has two years following the issuance
of the final risk evaluation to address, by rule, the unreasonable risks identified.
• State actions on NMP:
o Some states have taken actions on NMP. New Hampshire regulates NMP as a toxic
air pollutant, and Vermont regulates NMP as a hazardous air contaminant. Several
states, including Washington, Vermont and Oregon have adopted reporting laws for
chemicals, including NMP, in children's products. Minnesota lists NMP as a
chemical of concern to children. Massachusetts, New Jersey and Pennsylvania list
NMP under their State Right-to-Know laws.
o California has taken several actions on NMP. California has a Permissible Exposure
Limit for NMP of 1 ppm as an 8-hour time-weighted average (TWA) along with a
skin notation. California lists NMP on Proposition 65 due to reproductive toxicity and
has established a Maximum Allowable Dose Level (MADL) for inhalation and for
dermal exposure. California Department of Toxic Substances Control's Safer
Consumer Products Program listed NMP as a Candidate Chemical for developmental
and reproductive toxicity and in 2018 proposed to list Paint and Varnish Strippers and
Graffiti Removers Containing NMP as a priority product.
NEXT STEPS
• EPA has issued the final risk evaluation for NMP, meeting the requirements set forth in
TSCA section 6(b). EPA is now initiating the process to address the unreasonable risks
identified. EPA has two years following the issuance of the final risk evaluation to address,
by rule, the unreasonable risks identified.
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SUMMARY OF UNREASONABLE RISK DETERMINATIONS
EPA has determined that the following conditions of use of NMP do not present an unreasonable
risk of injury to health or the environment. These determinations are considered final agency
action and are being issued by order pursuant to TSCA Section 6(i)(l).
C onditions ol" I so 1 h:il Do Not Present ;i 11 Inrensonnhle Kisk
• Distribution in commerce
• Industrial and commercial use in ink, toner and colorant products in printer ink and inks in
writing equipment
• Industrial and commercial use in other uses in soldering materials
• Industrial and commercial use in other uses in fertilizer and other agricultural chemical
manufacturing, processing aids and solvents
• Consumer use in paint and coating removers
• Consumer use in adhesive removers
• Consumer use in paints and coatings in lacquers, stains, varnishes, primers and floor finishes
• Consumer use in paint additives and coating additives not described by other codes in paints
and arts and crafts paints
• Consumer use in other uses in automotive care products
• Consumer use in other uses in cleaning and furniture care products, including wood cleaners
and gasket removers
• Consumer use in other uses in lubricant and lubricant additives, including hydrophilic
coatings
EPA has determined that the following conditions of use of NMP present an unreasonable risk of
injury to health or the environment. EPA will initiate TSCA Section 6(a) risk management
actions on these conditions of use as required under TSCA Section 6(c)(1). Pursuant to TSCA
Section 6(i)(2), the unreasonable risk determinations for these conditions of use are not
considered final agency action.
Msiniirsu'liiring llisil Presents sin Inrensonnble Kisk
• Domestic manufacture
• Import
Processing tlint Presents :i 11 Inrensonnble Kisk
• As a i caclaiil or intermediate in plastic material and resin manufacturing and other 11011-
incorporative processing
• Incorporation into a formulation, mixture or reaction product in multiple industrial sectors
• Incorporation into articles in lubricants and lubricant additives in machinery manufacturing
• Incorporation into articles in paint additives and coating additives not described by other codes
in transportation equipment manufacturing
• Incorporation into articles as a solvent (which becomes part of a product formulation or
mixture) including in textiles, apparel and leather manufacturing
• Incorporation into articles in other sectors, including in plastic product manufacturing
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• Repackaging in wholesale and retail trade
• Recycling
Intluslriiil :iii(I ( oinnicrcinl I scs
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