Appendices to Final Report of the Small
Business Advocacy Review Panel on Toxic
Substances Control Act (TSCA) Section 6(a)
Rulemaking for N-Methylpyrrolidone
(NMP)
Appendix Al: Materials Shared with Sir ;presentatives for the Pre-Panel
Outreach Meeting, March 28, 2023
Appendi J • I luteirials Shared with Sin i Hill I ni if I epresentatives for the Panel
Outreach Meeting, May
Appenc i Comments Submitted by Small Entity Representatives
following tin I ii« II -I,'1 ii'll in si Outreach Meeting
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Final Report of the Small Business Advocacy Review Panel on Toxic Substances Control Act (TSCA)
Section 6(a) Rulemaking for N-Methylpyrrolidone (NMP)
Appendix Al: Materials Shared with Sin !! If 11 r i r > If ,, |jreseiitatlv'j> t> a* the
If11 -" II \ -I i ' cli Meeting, Mar. 11 " ' 11"
Table of Contents
Agenda Al-2
Panel Process Presentation Al-7
Pre-Panel Rulemaking Presentation Al-17
Industry Sectors with Small Entities Potentially Affected by the Rule Al-105
Related Regulations (EPA, Federal, State, and International) Al-114
SER Questions for Discussion Al-123
Personal Protective Equipment Respirator System Per Worker Unit Cost Breakdown Al-132
Potential Regulatory Options and Estimated Costs Al-138
Information on Weight Fractions of NMP Evaluated in the 2020 Risk Evaluation Al-145
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Agenda
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EPA's SBAR Pre-Panel Outreach Meeting with Small Entity Representatives on the
Proposed Rulemaking for n-Methylpyrrolidone (NMP) under TSCA Section 6(a)
March 28, 2023, l:00pm-4:00pm, Eastern time zone
Agenda
1:00 Welcome and Opening Remarks
• Bill Nickerson (EPA Small Business Advocacy Chair / Office of Policy)
• Brian Symmes (Acting Director, Existing Chemicals Risk Management Division, EPA
Office of Chemical Safety and Pollution Prevention)
• Tayyaba Zeb (Small Business Administration, Office of Advocacy)
• Austin Mudd (Office of Management and Budget, Office of Information and Regulatory
Affairs)
1:15 SER Introductions
1:25 Presentation on Panel process (Bill Nickerson, EPA SB AC)
1:35 Presentation on proposed rulemaking for NMP under TSCA section 6(a) (Office of
Chemical Safety and Pollution Prevention)
• Consultations with Small Entity Representatives (SERs)
• Overview of the unreasonable risk determinations in the risk evaluation and the risk
management requirements under TSCA
• Overview of conditions of use in the rulemaking and basis for unreasonable risk
determination
• Section 6 risk management overview: EPA's authority to regulate occupational and
consumer risks, key "tools in the toolbox" for managing unreasonable risks
• Potential regulatory options
2:05 Discussion on conditions of use (COU) with unreasonable risk determinations. (See list at
endfor all conditions of use by group).
• Detailed description of NMP use
• Your experience with exposure control and risk reduction
• Possible risk management actions
• Cost associated with implementations
• Available alternatives
• Other implementation considerations
NMP COU Group 1: Manufacturers, Repackaging/Recycling, and Disposal
NMP COU Group 2: Commercial Processing and Formulation Uses
NMP - March 28, 2023 1
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2:50 Break
3:00 Discussion (continued)
NMP COU Group 3: Industrial and Commercial Paint, Coating, and Solvent Uses
NMP COU Group 4: Industrial and Commercial Uses in Manufacturing of Electronic
Parts, Semiconductors, and Lithium Ion Batteries
NMP COU Group 5: Consumer Uses
3:45 Closing session
• Closing remarks from EPA, SBA, and OMB
• Wrap up and next steps (what to expect next)
4:00 Adjourn
NMP - March 28, 2023
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Condition of Use Discussion Groups
Group 1: Manufacturing, Repackaging/Recycling, and Disposal
- Includes the following conditions of use:
• Manufacturing (domestic manufacture)
• Manufacturing (import)
• Processing: repackaging in wholesale and retail trade
• Processing: recycling
• Disposal
Group 2: Commercial Processing and Formulation Uses
- Includes the following conditions of use:
• Processing - as a reactant or intermediate in plastic material and resin manufacturing and
other non-incorporative processing
• Processing - Incorporation into a formulation, mixture or reaction product in multiple
industrial sectors
• Processing - Incorporation into articles in lubricants and lubricant additives in machinery
manufacturing
• Processing - Incorporation into articles as a solvent (which becomes part of a product
formulation or mixture) including in textiles, apparel and leather manufacturing
• Processing - Incorporation into articles in paint additives and coating additives not
described by other codes in transportation equipment manufacturing
• Processing - Incorporation into articles in other sectors, including in plastic product
manufacturing
Group 3: Industrial and Commercial Paint, Coating, and Solvent Uses
- Includes the following conditions of use:
• Industrial and commercial use in paints, coatings and adhesive removers
• Industrial and commercial use in paints and coatings in lacquers, stains, varnishes,
primers and floor finishes and powder coatings in surface preparation
• Industrial and commercial use in in paint additives and coating additives not described by
other codes in multiple manufacturing sectors
• Industrial and commercial use in ink, toner and colorant products in printer ink and inks
in writing equipment
• Industrial and commercial use in processing aids, specific to petroleum production in
petrochemical manufacturing, in other uses in oil and gas drilling, extraction and support
activities, and in functional fluids (closed systems)
• Industrial and commercial use in adhesives and sealants including binding agents, single
component glues and adhesives, including lubricant adhesives, and two-component glues
and adhesives including some resins
• Industrial and commercial use in other uses in soldering materials
NMP - March 28, 2023
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• Industrial and commercial use in other uses in anti-freeze and de-icing products,
automotive care products, and lubricants and greases
• Industrial and commercial use in other uses in metal products not covered elsewhere, and
lubricant and lubricant additives including hydrophilic coatings
• Industrial and commercial use in other uses in laboratory chemicals
• Industrial and commercial use in other uses in cleaning and furniture care products,
including wood cleaners and gasket removers
• Industrial and commercial use in other uses in fertilizer and other agricultural chemical
manufacturing, processing aids and solvents
Group 4: Industrial and Commercial Uses in Manufacturing of Electronic Parts,
Semiconductors, and Lithium Ion Batteries
- Includes the following condition of use:
• Industrial and commercial use in paint additives and coating additives not described by
other codes in computer and electronic product manufacturing for use in semiconductor
manufacturing
• Industrial and commercial use in paint additives and coating additives not described by
other codes in computer and electronic product manufacturing in electronic parts
manufacturing
• Industrial and commercial use as a solvent (for cleaning or degreasing) in electrical
equipment, appliance and component manufacturing
• Industrial and commercial use as a solvent (for cleaning or degreasing) in electrical
equipment, appliance and component manufacturing for use in semiconductor
manufacturing
• Industrial and commercial uses in other uses in lithium ion battery manufacturing
Group 5: Consumer Use
- Includes the following condition of use:
• Consumer use in adhesives and sealants in glues and adhesives, including lubricant
adhesives and sealants
NMP - March 28, 2023
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Panel Process Presentation
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An Overview of the Small Business Advocacy
Review (SBAR) Panel Process
March 2023
Bill Nickerson, EPA's Small Business Advocacy Chair
Office of Regulatory Policy and Management
Office of Policy
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Why does EPA convene an SBAR Panel?
The Regulatory Flexibility Act (RFA) as amended
by the Small Business Regulatory Enforcement
Fairness Act (SBREFA), requires agencies to:
"assure that small entities have been given an opportunity to
participate in the rulemaking process" for any rule "which will
have a significant economic impact on a substantial
number of small entities."
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What is an SBAR Panel?
An EPA Small Business Advocacy Review (SBAR) Panel is
made up of four managers from three federal agencies:
EPA's Small Business Advocacy Chair (EPA's SBAC is from OP)
A manager from the EPA program responsible for writing the rule
^ [5 A U.S. Small Business
#\ Administration
¦ 1
K&ys
The Small Business Administration's Chief Counsel for Advocacy
The Administrator of the Office of Management and Budget's
(OMB's) Office of Information and Regulatory Affairs (OIRA)
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What does an SBAR Panel do?
The RFA tasks the Panel with reviewing the material the Agency
has available concerning the rulemaking, and collecting advice
and recommendations from small entity representatives (SERs)
on issues related to the following four elements:
• Who are the small entities to which the proposed rule will apply?
• What are the anticipated compliance requirements of the upcoming proposed
rule?
• Are there any existing federal rules that may overlap or conflict with the
regulation?
• Are there any significant regulatory alternatives that could minimize the impact
on small entities?
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SERs Participation in the Pre-panel and Panel process
SERs are invited to 2 meetings: Pre-panel Outreach meeting and
Panel Outreach meeting
• At each meeting, SERs participate in the discussion about how the rule
might impact them and provide suggestions about how to minimize that
impact.
• Panel Outreach meeting will focus on further refining SER advice and
recommendations from the Pre-panel Outreach
SERs are invited to supplement the verbal meeting discussions with
written comments (due 2 weeks after each meeting)
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SER FAQ webpage https://www.epa.gov/reg-flex/frequent-questions-small-entities.
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Where does the Panel process fit within the rulemaking process?
EPA's Pre-
Panel Outreach
Meeting with
SERs
Panel Outreach
Meeting with
SERs
Panel Report
to EPA's
Administrator
Notice of
Proposed
Rulemaking
Public
Comment
Period
Final Rule
It is EPA's goal to host SBAR Panels well before a proposed rule
is written so there is adequate time to incorporate Panel
recommendations into senior management decision-making about
the proposed rule
SER participation in the Pre-panel and Panel Outreach meetings
does not preclude or take the place of participation in the normal
public comment period at the time the rule is proposed
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What does the Panel do with the information,
advice, and recommendations from SERs?
The Panel prepares a Panel Report
• SER comments are summarized, and written comments are
included as an appendix
• SER information, advice, and recommendations are synthesized
into a set of Panel recommendations
• Submitted to the EPA Administrator
• Considered during senior-management decision-making prior to
the issuance of the proposed rule
• Placed in the rule's docket when the proposed rule is published
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Thank You
We realize that small entities make significant
sacrifices to participate in this process
Thank you for taking time and effort away from
your business or organization to assist the Panel in
this important work
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Contact Information for SBAC Staff
Lanelle Wiggins, RFA/SBREFA Team Leader
EPA Office of Policy
202-566-2372
wiaQins.lanelle@epa.Qov
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Pre-Panel Rulemaking Presentation
AM 7
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N-Methylpyrrolidone (NMP)
Small Entity Consultation
Proposed Rulemaking under TSCA Section 6
Office of Pollution Prevention and Toxics
U.S. Environmental Protection Agency
Pre-Panel Outreach Meeting with Small Entity Representatives
March 28, 2023
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Overview
• SERs and the regulatory process
• Findings from the risk evaluation for NMP
• Overview of conditions of use (COU) in the rulemaking
• Basis for unreasonable risk determination
• Risk management requirements under TSCA
• EPA's authority and "tools in the toolbox"
• Potential regulatory options
• Additional discussion with Small Entity Representatives
• Closing remarks
U.S. Environmen^l^rotectiori Agency
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Consultation with Small Entity Representatives
• EPA is interested in not only information, but also advice and
recommendations from the small entity representatives (SERs)
• EPA will use this information to inform the agency's decision on potential
regulatory options and to develop a regulatory flexibility analysis, which
becomes part of the record for the potential regulation
U.S. Environmen^l^rotection Agency
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Consultation with Small Entity Representatives
• Key elements in this regulatory flexibility analysis:
- Number of small entities to which the potential rule would apply
- Projected compliance requirements of the potential rule
- Identification of all relevant Federal rules which may duplicate, overlap or conflict
with the potential rule
- Any significant alternatives to the potential rule which accomplish the stated
objectives, and which minimize significant economic impact of the potential rule on
small entities
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Potentially Affected Entities
• The potentially affected industries/sectors for this proposed rule are identified by NAICS code, SBA
thresholds and U.S. Census Bureau Statistics of U.S. Business datasets, published annually
• 244 industries/sectors and their associated NAICS code have been identified although not all of the
small firms indicated in the attachment are necessarily expected to be impacted by the proposed rule
• SBA size standards vary greatly by NAICS code and range from $8 - $47 million and 100-1,500
employees
• The attachment "Industry Sectors with Small Entities Potentially Affected by the Rulemaking" provides
small firm statistics (size standard or number of smalls) for each industry/sector or use category
• EPA estimates 95% of firms are small entities that may be impacted by the proposed rule
• As more specific information about each entity is identified, it is possible that some entities could be
dropped from the list
U.S. EnvironmenJ^IJgrotection Agency
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SERs and the Regulatory Process
• We are seeking information on how the options presented might impact
your business or organization
- Provide specific examples of impacts
- Provide cost data, if available
- Please see detailed questions in a separate handout
U.S. Environmen^l^rotection Agency
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SERs and the Regulatory Process
• We are also seeking alternative methods of regulating unreasonable risks
identified for NMP
- Suggest other relevant options, including data costs and information on how to ensure
compliance
- Suggest ways that small businesses could benefit from flexibilities, such as different
compliance timetables, simplified reporting requirements, and exemptions
• We would like to minimize duplication
- Provide information on any duplicative or contradictory federal, state, county, or city
regulations you are aware of
- For a list of existing regulations, please see summary of related regulations
U.S. Environmen^l^rotection Agency
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Overview of the Risk Evaluation for NMP
• Risk evaluation published December 30, 2020:
- 37 conditions of use were evaluated
- Risk evaluation follows a series of opportunities for public input into EPA's NMP risk
evaluation activities
- NMP draft risk evaluation: December 2019; NMP problem formulation: June 2018;
NMP scope document: June 2017
U.S. Environmen^l^rotection Agency
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Overview of the Risk Evaluation for NMP
• Public comments arid external scientific peer review informed the final risk
evaluation
- 35 public comments received on the draft risk evaluation (comment period closed
January 21, 2020)
- Peer review: EPA's Science Advisory Committee on Chemicals (SACC) met to review
the draft evaluation (December 2019)
• The risk evaluation and supplemental materials are in docket
, with additional materials supporting the risk evaluation process in
docket EPA-HQ-QPPT-2016-0743. on www.reaulations.gov
U.S. Environmen^l^rotection Agency
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Determination of Unreasonable Risk
• In the December 2020 risk evaluation, EPA determined that NMP presented unreasonable
risk to health and the environment. In that risk evaluation, EPA determined that 26 of the 37
conditions of use (COU) of NMP presented unreasonable risk
• With EPA's policy change to a whole chemical approach, EPA has issued a revised whole
chemical unreasonable risk determination without presuming use of PPE. The changes from
that revised determination are included in this presentation and available at
https://www.epa.qov/assessinq-and-manaqinq-chemicals-under-tsca/final-risk-evaluation-n-
methvlpyrrolidone-nmp
• There may be some conditions of use that EPA has determined do not drive the
unreasonable risk but may still be subject to regulation due to uses elsewhere in the supply
chain that drive the unreasonable risk
U.S. Environmen^l^rotectiori Agency
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Recent Changes to the Risk Determination
EPA released for public comment a draft revision to the unreasonable risk determination for NMP on
July 1, 2022
EPA published the final revised risk determination on December 19, 2022
Incorporates policy changes announced in June 2021
Specifically, EPA has determined that:
- Making an unreasonable risk determination for NMP as a whole chemical substance, rather than unreasonable
risk determinations separately on each individual condition of use in the risk evaluation, is the most appropriate
approach to NMP under the statute and implementing regulations
- The risk determination does not rely on assumptions regarding the use of personal protective equipment (PPE)
in making the unreasonable risk determination under TSCA section 6, even though some facilities might be
using PPE as one means to reduce workers' exposures; rather, the use of PPE would be considered during risk
management as appropriate
U.S. Environmental Protection Agency
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Recent Changes to the Risk Determination
Removing the assumption that workers always and appropriately wear PRE in making the whole
chemical risk determination for NMP result in:
- Three additional conditions of use that drive the unreasonable risk determination for NMP:
• Industrial and commercial use in ink, toner, and colorant products;
• Industrial and commercial use in other uses soldering materials;
• Industrial and commercial use in other uses in fertilizer and other agricultural chemical
manufacturing—processing aids and solvents
U.S. Environmen^lj^rotectiori Agency
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Recent Changes to the Risk Determination Cont.
• Additionally, removing the assumption that workers always and appropriately wear PPE in
making the whole chemical risk determination for NMP result in risks for acute non-cancer
effects from inhalation and dermal exposures also driving the unreasonable risk in five
conditions of use (where previously those conditions of use were identified as presenting
unreasonable risk from chronic non-cancer effects):
- Processing for incorporation into articles in paint additives and coating additives not described by other codes in
transportation equipment manufacturing;
- Industrial and commercial use in paints, coatings, and adhesive removers;
- Industrial and commercial use in paints and coatings in lacquers, stains, varnishes, primers, and floor finishes,
powder coatings (surface preparation);
- Industrial and commercial use paint additives and coating additives in multiple manufacturing sectors; and
- Industrial and commercial use in adhesives and sealants including binding agents, single component glues and
adhesives, including lubricant additives, two-component glues, and adhesives including some resins.
U.S. Environmen^l^rotection Agency
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Recent Changes to the Risk Determination Cont.
• Overall, 29 conditions of use out of 37 EPA evaluated drive the NMP whole chemical
unreasonable risk determination
• EPA has not conducted new scientific analysis on NMP; the risk evaluation continues to
characterize risks associated with individual conditions of use
• The final risk determination is in docket E 3A-HQ-OPP -2016-0743 at regulations.gov
U.S. Environmen^l^rotection Agency
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Recent Changes to the Risk Determination
Separately, EPA is conducting a screening approach to assess potential risks from the air and water
pathways for several of the first 10 chemicals, including NMP
- This screening analysis was presented to the SACC in March and EPA is currently incorporating comments from
the SACC and public commenters on revisions to the analysis
Exposure pathways that were or could be regulated under another EPA-administered statute were
excluded from the 2020 NMP risk evaluation, resulting in certain air and water pathways not being fully
assessed
EPA's screening approach will identify if there are risks that were unaccounted for in the risk evaluation
for NMP
If the results suggest there is additional risk, EPA will determine if the risk management approach being
contemplated for NMP will protect against these risks or if the risk evaluation will need to be formally
supplemented or revised
U.S. Environmen^y|rotection Agency
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NMP Manufacturing and Processing Uses that Drive the
Unreasonable Risk
Manufacturing (domestic manufacturing)
Manufacturing (import)
Processing: As a reactant/intermediate in plastic material and resin manufacturing and other non-
incorporative processing
Processing: Incorporation into formulation, mixture or reaction product in multiple industrial sectors
Processing: Incorporation into articles in lubricants and lubricant additives in machinery manufacturing
Processing: Incorporation into articles in paint additives and coating additives not described by other codes in
transportation equipment manufacturing
Processing: Incorporation into articles as a solvent (which becomes part of a product formulation or mixture)
including in textiles, apparel and leather manufacturing
Processing: Incorporation into articles in other sectors, including in plastic product manufacturing
Processing: Repackaging in wholesale and retail trade
Processing: Recycling
U.S. Environmental Protection Agency 16
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NMP Industrial and Commercial Uses that Drive the Unreasonable
Risk
Industrial and commercial use in paints, coatings and adhesive removers
Industrial and commercial use in paints and coatings in lacquers, stains, varnishes, primers and floor finishes and
powder coatings in surface preparation
Industrial and commercial use in paint additives and coating additives not described by other codes in computer and
electronic product manufacturing in electronic parts manufacturing
Industrial and commercial use in paint additives and coating additives not described by other codes in computer and
electronic product manufacturing for use in semiconductor manufacturing
Industrial and commercial use in in paint additives and coating additives not described by other codes in multiple
manufacturing sectors
Industrial and commercial use as a solvent (for cleaning or degreasing) in electrical equipment, appliance and
component manufacturing
U.S. Environmental Protection Agency
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NMP Industrial and Commercial Uses that Drive the Unreasonable Risk
Industrial and commercial use as a solvent (for cleaning or degreasing) in electrical equipment, appliance and
component manufacturing for use in semiconductor manufacturing
Industrial and commercial use in ink, toner and colorant products in printer ink and inks in writing equipment
Industrial and commercial use in processing aids, specific to petroleum production in petrochemical
manufacturing, in other uses in oil and gas drilling, extraction and support activities, and in functional fluids
(closed systems)
Industrial and commercial use in adhesives and sealants including binding agents, single component glues
and adhesives, including lubricant adhesives, and two-component glues and adhesives including some resins
Industrial and commercial use in other uses in soldering materials
U.S. Environment^ Protection Agency
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NMP Industrial and Commercial Uses and Disposal that Drive the
Unreasonable Risk
Industrial and commercial use in other uses in anti-freeze and de-icing products, automotive care products, and
lubricants and greases
Industrial and commercial use in other uses in metal products not covered elsewhere, and lubricant and lubricant
additives including hydrophilic coatings
Industrial and commercial use in other uses in laboratory chemicals
Industrial and commercial uses in other uses in battery manufacturing
Industrial and commercial use in other uses in cleaning lithium-ion and furniture care products, including wood
cleaners and gasket removers
Industrial and commercial use in other uses in fertilizer and other agricultural chemical manufacturing, processing
aids and solvents
Disposal
U.S. Environment^ Protection Agency
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NMP Consumer Uses that Drive the Unreasonable Risk
Consumer use in adhesives and sealants in glues and adhesives, including lubricant adhesives and sealants
U.S. Environmen^l^rotection Agency
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Basis for Unreasonable Risk Determination: Workers
• The unreasonable risk determination for workers is based on the following health hazards
during occupational exposures to NMP:
- Developmental effects from acute inhalation and dermal exposures
- Reproductive effects from chronic inhalation and dermal exposures
• Consideration of Personal Protective Equipment (PPE):
- EPA does not assume that workers are always provided or appropriately wear PPE, for the purposes of unreasonable
risk determination
- EPA does not assume that it is a standard industry practice that workers in some small commercial facilities (e.g., those
performing cleaning or degreasing, using automotive care products, soldering materials, or commercial printing and
copying) have a respiratory protection program or regularly employ dermal protection; therefore, the use of respirators
and gloves is assumed to be unlikely for workers in these facilities
- When no PPE is assumed to be in place, 29 of the 37 COUs drive the unreasonable risk
- As previously noted, this assumption results in three additional COUs driving the unreasonable risk determination, and
five conditions of use with acute effects in addition to chronic affects driving the unreasonable risk determination
U.S. Environmen^l^rotection Agency
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Basis for Unreasonable Risk Determination: Consumers
• The unreasonable risk determinations for consumers is based on the following health
hazards during consumer exposures to NMP:
- Developmental toxicity from acute inhalation and dermal exposure
• The unreasonable risk determinations were based on the high intensity risk estimates for
consumers
• EPA did not evaluate chronic exposures to NMP for consumer users because EPA
considered the frequency of consumer product use to be too low to create chronic risk
concerns
U.S. Environmen^l^rotection Agency
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Related Regulations and TSCA Section 6 Authority
• NMP is subject to several federal laws and regulations in the United States and is also subject
to regulatory actions by states
- See separate document "Related Regulations (EPA, other Federal, State, and International)" for more information
on the regulatory history of NMP
• EPA determined that NMP presents an unreasonable risk to workers and consumers in the
TSCA risk evaluation
• Therefore, EPA is required to develop risk management actions under TSCA to address the
unreasonable risk
• TSCA Section 9 allows EPA to use statutory authorities to a sufficient extent by action taken
under a Federal law not administrated by the Administrator to reduce or eliminate identified risk
to health or the environment
U.S. Environm^!^ Protection Agency
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Risk Management Requirements
• Under TSCA, EPA is required to take action, to the extent necessary, to address chemicals
that pose unreasonable risks to human health or the environment
• EPA must issue a TSCA section 6(a) rule following risk evaluation to address all identified
unreasonable risks within two years:
- Proposed rule one year after risk evaluation
- Final rule two years after risk evaluation
• Specific requirements on consideration of alternatives, selecting among options and
statement of effects apply to risk management rules
• Input from stakeholders is critical to the process and EPA is seeking stakeholder input now
during the SBAR process and during the public comment period following the proposed rule
U.S. Environmen^lJ^rotection Agency
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TSCA 6a Rule Requirements (15 U.S.C 2605(c)(2)):
(A) Statement of effects
- In proposing and promulgating a rule under subsection (a) with respect to a chemical substance or mixture, the Administrator shall consider and
publish a statement based on reasonably available information with respect to—
- (i) the effects of the chemical substance or mixture on health and the magnitude of the exposure of human beings to the chemical substance or
mixture;
- (ii) the effects of the chemical substance or mixture on the environment and the magnitude of the exposure of the environment to such substance
or mixture;
- (iii) the benefits of the chemical substance or mixture for various uses; and
- (iv) the reasonably ascertainable economic consequences of the rule, including consideration of—
• (I) the likely effect of the rule on the national economy, small business, technological innovation, the environment, and public health;
• (II) the costs and benefits of the proposed and final regulatory action and of the 1 or more primary alternative regulatory actions considered
by the Administrator; and
• (III) the cost effectiveness of the proposed regulatory action and of the 1 or more primary alternative regulatory actions considered by the
Administrator.
(B) Selecting requirements
- In selecting among prohibitions and other restrictions, the Administrator shall factor in, to the extent practicable, the considerations under
subparagraph (A) in accordance with subsection (a).
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TSCA Section 6(a)
• TSCA provides EPA with authority to address unreasonable risks, and to regulate entities
including:
- Manufacturers (including importers and importers of articles) afl4
- Processors (e.g., formulators)
- Distributors
- Commercial users (workplaces and workers)
- Entities disposing of chemicals for commercial purposes
• Cannot directly regulate consumer users
- Under TSCA, EPA has authority to regulate at the manufacturing, processing and distribution
levels in the supply chain to eliminate or restrict the availability of chemicals and chemical-
containing products for consumer use
- These authorities allow EPA to regulate at key points in the supply chain to effectively address
unreasonable risks to consumers
U.S. Environmen^^Protection Agency 26
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TSCA Section 6(a) Regulatory Options
• Prohibit, limit or otherwise restrict manufacture, processing or distribution in commerce
• Prohibit, limit or otherwise restrict manufacture, processing or distribution in commerce for
particular use or for use above a set concentration
• Require minimum warnings and instructions with respect to use, distribution, and/or disposal
• Require recordkeeping, monitoring or testing
• Prohibit or regulate manner or method of commercial use
• Prohibit or regulate manner or method of disposal by certain persons
• Direct manufacturers/processors to give notice of the unreasonable risk determination to
distributors, users, and the public and replace or repurchase
U.S. Environmen^^Protection Agency 27
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Availability of Alternatives: TSCA Section 6(c)(2)(C)
• TSCA section 6(c)(2)(C) requires EPA.. 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...to the extent practicable, whether technically and economically
feasible alternatives that benefit health or the environment, compared to the
use so proposed to be prohibited or restricted, will be reasonably available as a
substitute when the proposed prohibition or other restriction takes effect"
- Substitute products and methods vary by condition of use
- For example, alternatives to NMP in paint and coating removal include solvent-based alternatives like
n-ethylpyrrolidone (NEP), benzyl alcohol, and other methyl acetate-based stripping formulations, or
process-based alternatives like heat and sanding (
content/uploads/sites/31/2019/09/Final-NMP-Paint-Stripper-Graffiti-Remover Profile.pdf)
U.S. Environm^it^ Protection Agency 28
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Effective Dates: TSCA Section 6(d)
• TSCA section 6(d) describes effective dates and compliance dates for TSCA section 6(a) rules
• In these rules, EPA must specify an effective date, which must be as soon as practicable
• Except for uses exempted under TSCA section 6(g), EPA must:
- Specify mandatory compliance dates for all rule requirements, no later than five years after
promulgation of the rule, or, in the case of a ban or phase-out:
• Specify mandatory compliance dates for the start of a ban or phase-out requirements, which shall be as
soon as practicable and no later than five years after promulgation of the rule, and
• Specify mandatory compliance dates for full implementation of a ban or phase-out requirements, which
shall be as soon as practicable
• EPA must also provide for a reasonable transition period
U.S. Environmen^lJJrotection Agency
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Critical or Essential Uses: TSCA Section 6(g)
TSCA Section 6(g) allows EPA to grant, by rule, a time-limited exemption from a section 6(a) rule for a specific condition of use
• EPA can provide an exemption under three conditions:
— The specific condition of use is a critical or essential use for which no technically and economically feasible safer alternative is available;
— Compliance with the rule would significantly disrupt the national economy, national security, or critical infrastructure; or
— The specific condition of use, as compared to alternatives, provides a substantial benefit to health, the environment, or public safety
In granting an exemption, EPA must:
— Provide a time limit for the exemption
— Analyze the need for the exemption and make the analysis public
— Include conditions, such as recordkeeping, monitoring, and reporting requirements, to the extent EPA determines they are necessary to protect health and the
environment while achieving the purposes of the exemption
EPA appreciates any information to inform whether it would be appropriate to propose an exemption under section 6(g), such as:
— How the exemption request for a COU would meet one or more of the criteria under section 6(g) and information on specific impacts if the chemical were not available
— Whether the chemical is used to meet requirements or specifications from other regulations, describe the process, timeline, and challenges for obtaining
industry/government approval for use of an alternative substance or method
— Description of how long a potential section 6(g) exemption would be needed and why
U.S. Environ^jejiJal Protection Agency
30
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Hierarchy of Controls
EPA is considering the NIOSH/OSHA
hierarchy of controls when developing risk
management actions
- As described by NIOSH
(https://www.cdc.gov/niosh/topics/hierarchv/default.html),
the hierarchy of controls can be used to implement
feasible and effective controls to protect workers
- It typically includes elimination, substitution, engineering
controls, administrative controls, and PRE on a scale of
most to least protective
Any regulatory requirement can be used alone or
in combination to the extent necessary so that
NMP no longer presents an unreasonable risk
under its conditions of use
Most
effective
Hierarchy of Controls
¦
Least
effective
Elimination
Substitution
Engineering
Controls
Administrative
Controls
PPE f—
f
¥
Physically remove
the hazard
Replace
the hazard
Isolate people
from the hazard
Change the way
people work
Protect the worker with
Personal Protective Equipment
image by NIOSH
b ttps-J/www. cdc gov/niosh/topics/h ierarchy/defa u It. h tm I
U.S. Environm^t|^ Protection Agency
31
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Potential Regulatory Options
• EPA has considered several regulatory options under TSCA section 6(a), and a wide range of risk
reduction practices and options
• Through Agency review and stakeholder input, the following potential options have been identified
as reducing exposures, so NMP no longer presents an unreasonable risk of injury to health
• These options are currently being considered and evaluated by EPA, and are not final at this time.
EPA has not made a decision at this point about what regulatory options to propose
• Regulatory requirements could be used alone or in combination to the extent necessary so that
NMP no longer presents an unreasonable risk under its conditions of use
- Additionally, under TSCA section 6(g), EPA may propose a time-limited exemption for a specific condition
of use under three circumstances, as discussed previously on slide 30
U.S. Environm^it|^ Protection Agency
32
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Potential Regulatory Options
Prohibit use above a set concentration (concentration limits)
Prescriptive PPE controls
Prescriptive administrative controls
Prescriptive engineering controls
Combination of controls (non-prescriptive)
Prohibit or restrict manufacturing, processing, and distribution
Prohibit or restrict manufacturing, processing, and distribution for a particular
Regulatory options applied broadly with other restrictions
- Recordkeeping and downstream notification
- Monitoring and labeling
- Training, certification, and limited access program
U.S. Environmen^y^rotection Agency
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Potential Regulatory Options, cont.
• EPA has not decided on the primary regulatory options to propose in the rule.
• Nonetheless, EPA's primary performance metric for eliminating the unreasonable risk
of injury to human health is to eliminate or reduce significantly direct dermal contact
with NMP. EPA is considering the following regulatory options and seeking feedback
on the impacts of applying one or more of the following regulatory options to address
the unreasonable risk from NMP.
• Unlike some of the other chemicals currently undergoing risk management under
TSCA section 6, EPA is not considering an airborne concentration limit for NMP and is
focusing on dermal protection measures. The 2020 risk evaluation for NMP and
revised unreasonable risk determination found that the unreasonable risk of injury to
human health is driven by direct dermal contact with liquid NMP.
U.S. Environmen^l^rotectiori Agency
34
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Potential Regulatory Options, cont.
• For processing, industrial, and commercial uses (occupational exposures) EPA is considering the following
regulatory options to address the unreasonable risk:
- Concentration Limit
• A risk management option that would restrict the concentration or weight fraction within the formulation.
• For example, if scientific analysis supported it, EPA could limit the percentage amount of the chemical in the
formulation if that percentage addressed the unreasonable risk and the formulation was still efficacious.
• In the 2020 Risk Evaluation for NMP, EPA identified the expected weight fraction of NMP in liquid products based
on publicly available information, public comments, and available products on the market. If ranges of NMP in
formulations were identified, EPA generally assessed the lower bound of the range as the central tendency and the
upper bound of the range as the high end.
- Example: EPA identified and assessed the commercial use of NMP in paints, coatings, adhesives and sealants based on
products with 2-53% NMP. At the high-end concentration, in the expected occupational exposure scenarios, these conditions
of use drive the unreasonable risk.
- Example: EPA identified and assessed the commercial use of NMP in metal finishing products with 60-90% NMP. At these
concentrations, in the expected occupational exposure scenarios, this condition of use drives the unreasonable risk.
• There is uncertainty if lowering the concentration limit may impact efficacy of the products. For a concentration or
weight fraction limit to address the unreasonable risk, it would need to be lower than those that drove the
unreasonable risk in the risk evaluation.
U.S. Environmen^l^rotectiori Agency
35
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Potential Regulatory Options, cont.
• Prescriptive Engineering Controls
- Would reduce worker exposure by requiring specific physical changes to the workplace to
eliminate or reduce direct dermal contact
- Examples: installing additional or different equipment, such as enclosed transfer liquid lines,
closed loop container systems or a laboratory type fume hood, to reduce the exposure to the
chemical
• Prescriptive Administrative Controls
- Would reduce worker exposure by requiring processes or procedures in the workplace to eliminate
or reduce direct dermal contact
- Examples: Limit access to work areas (restricted areas) or confining operations (enclosed areas)
- EPA's confidence that the unreasonable risk from NMP can be addressed is highest for highly
standardized and industrialized settings, such as where NMP is used in a closed-loop system
U.S. Environmen^y^rotectiori Agency
36
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Potential Regulatory Options, cont
• Prescriptive PPE Controls
- A risk management option that would require the use of specific PPE to minimize exposure. This may limit flexibility for the regulated entity
Some examples of potential PPE that could contribute to reducing the unreasonable risk are listed separately in Appendix F of the 2020 final risk evaluation, as well
as the Potential Costs of Regulatory Options table later in this presentation
- Requiring the use of dermal and inhalation PPE that provides an impervious barrier in combination with a set concentration limit of NMP
would allow more flexibility for regulated entities to mitigate unreasonable risk
- EPA anticipates that PPE would need to be combined with training and other controls in order to address the unreasonable risk from NMP
Combination of Controls (non-prescriptive)
- A combination of risk management approaches for conditions of use where strict industrial practices may already exist. Enables users to
determine how to most effectively separate, distance, physically remove, or isolate workers from direct handling of NMP or from contact
with equipment/materials for which NMP may exist based on what works best for their workplace and the ability to combine prescriptive
controls
- Would eliminate direct dermal contact in accordance with the Pollution Prevention Act and NIOSH hierarchy of controls
- Could include engineering or administrative controls to reduce or eliminate exposure
- If direct dermal contact could not be eliminated using elimination, substitution, engineering controls, or administrative controls, could
require personal protective equipment that provides an impervious barrier
- Examples: Automation, barriers, or design of tools
U.S. Environmen^y^rotectiori Agency
37
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Potential Regulatory Options, cont.
• Prohibition
- EPA could include prohibition on manufacturing, processing, distribution, use, or disposal for
specific conditions of use or the chemical as a whole
- EPA requests data and feedback about availability and viability of NMP alternatives, testing and
analysis that SERs have completed of potential alternatives, the cost impacts of SERs
switching to alternatives, and the overall impacts to SERs' businesses if NMP is prohibited.
U.S. Environmen^l^rotection Agency
38
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Potential Regulatory Options, cont.
• For consumer uses, EPA is considering the following regulatory options to address the
unreasonable risk:
- Regulation at key points in the supply chain (manufacturing, processing, and/or distribution) to address
unreasonable risks to consumers
• Example: March 2019 rule to address unreasonable risks to consumers from methylene chloride in
paint and coating removal prohibited manufacture (including import), processing, and distribution in
commerce of methylene chloride for this use (including distribution to and by retailers)
- Potential regulatory options:
• Prohibition
• Concentration Limits
• Container size
U.S. Environmen^y^rotection Agency
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Potential Regulatory Options, cont
Regulatory options applied broadly with other restrictions
- Recordkeeping - example: ordinary business records to demonstrate compliance
(for example not selling products to consumers)
- Downstream notification - example: modify the SDS to indicate that the product
should not be used in consumer products or indicate other regulatory requirements
- Monitoring - example: monitor for compliance or concentration limits
- Labeling - example: labeling products to indicate that they should not be used by
consumers or to describe other regulatory requirements
- Container size - example: a minimum or maximum container size (e.g., 32 ounce
container, 55 gallon drum) to reduce likelihood of purchase by certain types of users
(consumers or commercial users)
- Limited access program - example: access only to users with certain equipment or
types of faci I ities u 3 ^
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Cost of Regulatory Options
Option/Type of Cost
Estimated Compliance
Cost
Notes
Prohibition of manufacturing,
processing, and distribution
Prohibition of Use
Varies with condition of use
Varies with condition of use
Cost will vary by condition of use. Potential activities could
include changes in process and equipment, costs of alternatives,
reformulation (see below), and more. Requires input from
potentially regulated entities.
Cost will vary by condition of use. Potential activities could
include changes in process and equipment, costs of alternatives,
reformulation (see below), and more. Requires input from
potentially regulated entities.
Reformulation of product to
reduce NMP concentration
$17,000 per product
Costs reflect dilution reformulation approach.
Reformulation of product to
eliminate NMP concentration
Costs will vary by condition of use and will be dependent on
$60,000-$102,000 per product reformulation approach. Requires input from potentially regulated
entities.
U.S. Environmen^l^rotectiori Agency 41
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Cost of Regulatory Options, cont.
Option/Type of Cost
Engineering/
Administrative Controls
Personal Protective Equipment
(PPE) - (e.g., respirators)
Estimated Compliance Cost
Varies by control type and needs of
user
APF10: $1,800
APF25: $1,300
APF50: $1,700
APF 1000: $1,100
APF 10000: $2,000
Personal Protective Equipment
(PPE) (dermal)
Reusable gloves: $6-$55
Disposable gloves: $0.50
Reusable apron:$25-$34
Disposable apron: $4
A1-59
U.S. Environmental Protection Agency
Notes
Requires input from potentially regulated entities
Annualized costs are per person and include
purchase of equipment (including filters), training, fit-
testing, and medical clearance. The unit costs include
a written respiratory program and equipment
cleaning. Does not include existing PPE use nor PPE
replacement due to employee turn-over. Includes
both purified and supplied air respirators.
Reusable glove costs are per pair of butyl, laminated
polyethylene, neoprene, and natural rubber/latex
gloves. Disposable glove costs are per pair of nitrile
gloves. Disposable nitrile gloves are not used alone,
but in combination with the reusable gloves.
Reusable apron costs are per nitrile and neoprene
apron. Disposable apron costs are per polyethylene
apron.
-------
Cost of Regulatory Options, cont.
Option/Type of Cost
Combination of controls (non-
prescriptive)
Estimated Compliance Cost
Annualized costs of Exposure control
plan:
$560-$630 per facility costs
$35 per worker costs
One-time costs of Exposure control plan:
- 40 hours one time cost to develop plan:
$3,730 per facility
- 4 hours annual cost for regular
inspections: $370 per facility per year
- 0.43 hours annual recordkeeping: $40
per facility per year
Notes
Non-prescriptive approach would likely include
development of an exposure control plan. Costs include
costs for conducting regular inspections, PRE program
plan documentation, records of plan implementation,
and records of dermal exposure. Includes both per-
facility and per-worker costs. Costs will depend on
baseline PRE and dermal exposure control plan
activities.
Costs of engineering controls,
monitoring, or PPE varies by control type
and needs of user
See PPE costs for glove and apron costs
A1-60
U.S. Environmental Protection Agency
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Cost of Regulatory Options, cont.
Option/Type of Cost
Estimated Compliance Cost
Notes
Product Label or Warnings
$830- $8,900 per product, one time cost
Costs will vary by condition of use. Potential
activities may nclude graphic design changes,
plate changes, discarded inventory, and labor.
Container Sizes
$9,500-$47,500 per product, one time cost
A change in container size would lead to costs at
the lower end while a packaging material change
would likely result in costs at the higher end.
Substitute Products (average per
ounce)
Varies with condition of use
Would vary by price of NMP per ounce vs.
substitutes, as well as the differences in efficacy of
the substitute products.
Substitute Methods
Varies by job labor rate
This will primarily be labor cost and cost of
alternative equipment.
U.S. Environmen^l^rotection Agency
44
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Cost of Regulatory Options, cont.
Option/Type of Cost
Estimated Compliance Cost
Notes
Recordkeeping
$218-$340 per firm
Ongoing annual labor and material costs
associated with documentation of ordinary
business records.
Downstream Notification
$121 -$138 per product, one time cost
Costs are per product and include labor and
material costs to update a product's safety data
sheet (SDS).
Limited Access Program
Varies with condition of use and type of
distributor
Would vary by type of requirements for
certification and any distribution processes or
restrictions already in place.
U.S. Environmen^y|rotectiori Agency
45
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In-Depth Discussion on Conditions of Use for NMP
1. Manufacturing, repackaging/recycling, and disposal
2. Commercial processing and formulation uses
3. Industrial and commercial paint, coating, and solvent uses
4. Industrial and commercial uses in manufacturing of
electronic parts, semiconductors, and lithium-ion batteries
5. Consumer uses
U.S. Environmen^y^rotectiori Agency
46
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NMP Group 1: Manufacturers, Repackaging/Recycling,
and Disposal
Relevant conditions of use:
- Manufacturing (domestic manufacture)
- Manufacturing (import)
- Processing: repackaging in wholesale and retail trade
- Processing: recycling
- Disposal
What is NMP used for? How is it applied?
- NMP is domestically manufactured, imported, and repackaged from bulk containers to smaller containers; NMP is
loaded and unloaded into different containers
- NMP waste streams are collected and transported to third-party sites for disposal, treatment, or recycling
U.S. Environmental Protection Agency
47
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Potential Regulatory Options for NMP Group 1:
Manufacturing, Repackaging/Recycling, and Disposal
As noted previously EPA is considering the following regulatory options and is seeking your
feedback. Any regulatory requirement could be used alone or in combination to the extent
necessary so that NMP no longer presents an unreasonable risk under its conditions of use:
• Prescriptive Controls (Engineering, Administrative, PPE)
• Combination of Controls (Non-Prescriptive)
• Prohibition
• Regulatory options applied broadly with other restrictions
- Recordkeeping and downstream notification
- Monitoring and labeling
U.S. Environmental Protection Agency
48
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Discussion with Small Entity Representatives
Please provide your comments or questions regarding:
• Number and types of small entities affected
• Potential reporting, recordkeeping and compliance
requirements
• Related Federal rules
• Regulatory flexibility alternatives
U.S. Environmen^y^rotection Agency
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Discussion - Your Business and NMP
• How does your organization use NMP?
• Can you describe the specific use, as well as the workplace and workplace
setting where it is used?
• What is the trend of NMP use in your organization?
• How important to your business is the function that NMP provides?
• Are there potential critical or essential uses?
• Are there uses for which there are no available technically or economically
feasible alternatives?
U.S. Environmen^y^rotection Agency 50
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Discussion - Workplace Exposure
• What is your experience with exposure control and risk reduction?
• How many employees are exposed to NMP, and for how long (days/years and hours/day)?
• What is the concentration of NMP in the product you use?
• What routine worker activities result in worker exposure to NMP and what type of exposure?
• What engineering controls are used to minimize exposure to NMP? Are additional controls
feasible?
• What administrative controls and training do you use to minimize exposure to NMP?
• What respiratory and dermal PPE is regularly worn by workers to minimize exposure to NMP?
U.S. Environmen^y^rotection Agency
51
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Discussion - Regulatory Options
• What regulatory approach should EPA take?
• Are there concerns about the ability to comply with any of the
potential regulatory options?
• What advice do you have for reducing impacts on small
businesses?
• What timeframe would your business need to comply with
potential new regulations or restrictions?
U.S. Environmen^y^rotectiori Agency
52
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NMP Group 2: Processors
Relevant conditions of use
- Processing - as a reactant or intermediate in plastic material and resin manufacturing and other non-incorporative
processing
- Processing - Incorporation into a formulation, mixture or reaction product in multiple industrial sectors
- Processing - Incorporation into articles in lubricants and lubricant additives in machinery manufacturing
- Processing - Incorporation into articles as a solvent (which becomes part of a product formulation or mixture) including
in textiles, apparel and leather manufacturing
- Processing - Incorporation into articles in paint additives and coating additives not described by other codes in
transportation equipment manufacturing
- Processing - Incorporation into articles in other sectors, including in plastic product manufacturing
What is NMP used for? How is it applied?
- NMP is commonly used as a feedstock in the production of other chemicals products and may be incorporated into
various products and formulations at varying concentrations for further distribution
- These uses entail use of NMP as an intermediate, as a media for synthesis, processing, and purification
- NMP may be used for maintenance, bottling, shipping, sampling and loading into or unloading from containers
U.S. Environmen^Lf^rotection Agency
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Potential Regulatory Options for NMP Group 2: Processors
As noted previously EPA is considering the following regulatory options and is seeking your
feedback. Any regulatory requirement could be used alone or in combination to the extent
necessary so that NMP no longer presents an unreasonable risk under its conditions of use:
• Concentration Limit
• Prescriptive Controls (Engineering, Administrative, PPE)
• Combination of Controls (Non-Prescriptive)
• Prohibition
• Regulatory options applied broadly with other restrictions
- Recordkeeping and downstream notification
- Monitoring and labeling
U.S. Environmen^L^rotection Agency
54
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Discussion with Small Entity Representatives
Please provide your comments or questions regarding:
• Number and types of small entities affected
• Potential reporting, recordkeeping and compliance
requirements
• Related Federal rules
• Regulatory flexibility alternatives
U.S. Environmen^Lf^rotectiori Agency
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Discussion - Your Business and NMP
• How does your organization use NMP?
• Can you describe the specific use, as well as the workplace and workplace
setting where it is used?
• What is the trend of NMP use in your organization?
• How important to your business is the function that NMP provides?
• Are there potential critical or essential uses?
• Are there uses for which there are no available technically or economically
feasible alternatives?
U.S. Environmen^L^rotection Agency 56
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Discussion - Workplace Exposure
• What is your experience with exposure control and risk reduction?
• How many employees are exposed to NMP, and for how long (days/years and hours/day)?
• What is the concentration of NMP in the product you use?
• What routine worker activities result in worker exposure to NMP and what type of exposure?
• What engineering controls are used to minimize exposure to NMP? Are additional controls
feasible?
• What administrative controls and training do you use to minimize exposure to NMP?
• What respiratory and dermal PPE is regularly worn by workers to minimize exposure to NMP?
U.S. Environmen^Lf^rotection Agency
57
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Discussion - Formulators of Products Containing NMP
• Product reformulation
- How often do you reformulate your products?
- What is the typical cost of reformulating your products?
- What might reformulation costs be if you needed to reformulate your products
without NMP? (For example, costs might include R&D, testing, capital costs of
production changes, packaging, labeling)
• Product relabeling
- How often do you relabel your products?
- What is the typical cost of relabeling?
U.S. Environmen^Lf^rotection Agency
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Discussion - Formulators of Products Containing NMP (Cont.)
• Alternatives
- Do you sell another product that does not contain NMP that is designed for
the same use or application as the NMP product?
• If yes, what solvent replaces NMP in the alternative product? How does the alternative
product compare in terms of safety, efficacy, and cost?
• If no, if you needed to reformulate this product with a lower concentration of NMP, what would
the implications be for the product in terms of cost and efficacy? What solvent would replace
NMP? How do you think the alternative would compare in terms of efficacy and cost?
- Are there any restrictions or other limitations that prescribe the use of NMP
to perform your services (e.g., for aerospace or DOD customers)?
- Is there a subset of uses for your product where using a product formulated
without NMP would be problematic?
U.S. Environmen^Lf^rotectiori Agency
59
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Discussion - Regulatory Options
• What regulatory approach should EPA take?
• Are there concerns about the ability to comply with any of the
potential regulatory options?
• What advice do you have for reducing impacts on small
businesses?
• What timeframe would your business need to comply with
potential new regulations or restrictions?
U.S. Environmen^Lf^rotectiori Agency
60
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NMP Group 3: Industrial and Commercial Paint and
Coating and Solvent Uses
• Relevant conditions of use:
- Industrial and commercial use in paints, coatings, and adhesive removers
- Industrial and commercial use in paints and coatings in lacquers, stains, primers and floor finishes and powder coatings in
surface preparation
- Industrial and commercial use in paint additives and coating additives not described by other codes in multiple manufacturing
sectors
- Industrial and commercial use in ink, toner and colorant products in printer ink and inks in writing equipment
- Industrial and commercial use in processing aids, specific to petroleum production in petrochemical manufacturing, in other uses
in oil and gas drilling, extraction and support activities, and in functional fluids (closed systems)
- Industrial and commercial use in adhesives and sealants including binding agents, single component glues and adhesives,
including lubricant adhesives, and two-component glues and adhesives including some resins
- Industrial and commercial use in soldering materials
- Industrial and commercial use in anti-freeze and de-icing, automotive care products, and lubricants and greases
- Industrial and commercial use metal products, lubricant and lubricant additives including hydrophilic coatings
- Industrial and commercial use in laboratory chemicals
- Industrial and commercial use in cleaning and furniture care products, including wood cleaners and gasket removers
- Industrial and commercial use in fertilizer and other agricultural chemical manufacturing, processing aids, and solvents
61
U.S. Environmental Prc&MSon Agency
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NMP Group 3: Industrial and Commercial Paint and
Coating and Solvent Uses
• What is NMP used for? How is it applied?
- NMP is used in paints and coatings, in paint/coating additives and as a solvent for cleaning and
degreasing to remove a variety of contaminants and materials in a variety of businesses
- NMP is used in processing aids in petroleum production in petrochemical manufacturing, in other
uses in oil and gas drilling, extraction and support activities and in functional fluids in a closed
system
- NMP is also used in adhesives and sealants and in various automotive care products including anti-
freeze, de-icing products and lubricants and greases
- NMP is also used in metal products
- Activities include loading/unloading, analytical and maintenance activities
U.S. Environmental Pro^ci^on Agency
62
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Potential Regulatory Options for NMP Group 3: Industrial
and Commercial Paint and Coating and Solvent Uses
As noted previously EPA is considering the following regulatory options and is seeking your feedback.
Any regulatory requirement could be used alone or in combination to the extent necessary so that NMP
no longer presents an unreasonable risk under its conditions of use:
• Concentration Limit
• Prescriptive Controls (Engineering, Administrative, PPE)
• Combination of Controls (Non-Prescriptive)
• Prohibition
• Regulatory options applied broadly with other restrictions
- Recordkeeping and downstream notification
- Monitoring and labeling
- Container size
U.S. Environmen^l^rotection Agency
63
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Discussion with Small Entity Representatives
Please provide your comments or questions regarding:
• Number and types of small entities affected
• Potential reporting, recordkeeping and compliance
requirements
• Related Federal rules
• Regulatory flexibility alternatives
U.S. Environmen^l^rotection Agency
-------
Discussion - Your Business and NMP
• How does your organization use NMP?
• Can you describe the specific use, as well as the workplace and workplace
setting where it is used?
• What is the trend of NMP use in your organization?
• How important to your business is the function that NMP provides?
• Are there potential critical or essential uses?
• Are there uses for which there are no available technically or economically
feasible alternatives?
-------
Discussion - Workplace Exposure
• What is your experience with exposure control and risk reduction?
• How many employees are exposed to NMP, and for how long (days/years and hours/day)?
• What is the concentration of NMP in the product you use?
• What routine worker activities result in worker exposure to NMP and what type of exposure?
• What engineering controls are used to minimize exposure to NMP? Are additional controls
feasible?
• What administrative controls and training do you use to minimize exposure to NMP?
• What respiratory and dermal PPE is regularly worn by workers to minimize exposure to NMP?
U.S. Environmen^y^rotection Agency 66
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Discussion - Users of Products Containing NMP
• What chemicals or processes have you considered as an alternative to using
NMP or a product containing NMP?
• Do you currently use any alternatives to NMP or products containing NMP?
• Did you try to switch to another chemical, process, or product, only to switch
back? If so, what did you switch to, why did you switch back, and what made you
switch in the first place?
• Are there any restrictions or other limitations that prescribe the use of NMP to
perform your services (e.g., for aerospace or DOD customers)?
• What are the relative advantages and disadvantages of different substitutes
and/or processes that you have considered, including in terms of exposure, cost,
and hazard?
U.S. Environmental Protection Agency
67
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Discussion - Regulatory Options
• What regulatory approach should EPA take?
• Are there concerns about the ability to comply with any of the
potential regulatory options?
• What advice do you have for reducing impacts on small
businesses?
• What timeframe would your business need to comply with
potential new regulations or restrictions?
U.S. Environmen^l^rotection Agency
68
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NMP Group 4: Industrial and Commercial Uses in
Manufacturing of Electronic Parts, Semiconductors, and
Lithium-Ion Batteries
• Relevant conditions of use:
• Industrial and commercial use in paint additives and coating additives not described by other codes in computer
and electronic product manufacturing in electronic parts manufacturing
• Industrial and commercial use in paint additives and coating additives not described by other codes in computer
and electronic product manufacturing for use in semiconductor manufacturing
• Industrial and commercial use as a solvent (for cleaning or degreasing) in electrical equipment, appliance
and component manufacturing
• Industrial and commercial use as a solvent (for cleaning or degreasing) in electrical equipment, appliance
and component manufacturing for use in semiconductor manufacturing
• Industrial and commercial uses in other uses in lithium-ion battery manufacturing
• What is NMP used for? How is it applied?
- NMP is used as a paint additive and coating additive and as a solvent in cleaning and degreasing in manufacturing of
electronic parts and semiconductors
- NMP is used in lithium-ion battery manufacturing in cathode coating, cathode mixing, and other activities
U.S. Environmen^y^rotection Agency 69
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Potential Regulatory Options for NMP Group 4: Industrial
and Commercial Uses in Manufacturing of Electronic Parts,
Semiconductors, and Lithium-Ion Batteries
As noted previously EPA is considering the following regulatory options and is seeking your
feedback. Any regulatory requirement could be used alone or in combination to the extent
necessary so that NMP no longer presents an unreasonable risk under its conditions of use:
• Prescriptive Controls (Engineering, Administrative, PPE)
• Combination of Controls (Non-Prescriptive)
• Prohibition
• Regulatory options applied broadly with other restrictions
- Recordkeeping and downstream notification
- Monitoring and labeling
U.S. Environmen^y^rotection Agency
70
-------
Discussion with Small Entity Representatives
Please provide your comments or questions regarding:
• Number and types of small entities affected
• Potential reporting, recordkeeping and compliance
requirements
• Related Federal rules
• Regulatory flexibility alternatives
U.S. Environmen^l^rotection Agency
-------
Discussion - Your Business and NMP
• How does your organization use NMP?
• Can you describe the specific use, as well as the workplace and workplace
setting where it is used?
• What is the trend of NMP use in your organization?
• How important to your business is the function that NMP provides?
• Are there potential critical or essential uses?
• Are there uses for which there are no available technically or economically
feasible alternatives?
U.S. Environmen^y^rotection Agency 72
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Discussion - Workplace Exposure
• What is your experience with exposure control and risk reduction?
• How many employees are exposed to NMP, and for how long (days/years and hours/day)?
• What is the concentration of NMP in the product you use?
• What routine worker activities result in worker exposure to NMP and what type of exposure?
• What engineering controls are used to minimize exposure to NMP? Are additional controls
feasible?
• What administrative controls and training do you use to minimize exposure to NMP?
• What respiratory and dermal PPE is regularly worn by workers to minimize exposure to NMP?
U.S. Environmen^y^rotection Agency
73
-------
Discussion - Users of Products Containing NMP
• What chemicals or processes have you considered as an alternative to using
NMP or a product containing NMP?
• Do you currently use any alternatives to NMP or products containing NMP?
• Did you try to switch to another chemical, process, or product, only to switch
back? If so, what did you switch to, why did you switch back, and what made you
switch in the first place?
• Are there any restrictions or other limitations that prescribe the use of NMP to
perform your services (e.g., for aerospace or DOD customers)?
• What are the relative advantages and disadvantages of different substitutes
and/or processes that you have considered, including in terms of exposure, cost,
and hazard?
U.S. Environmental Protection Agency
74
-------
Discussion - Regulatory Options
• What regulatory approach should EPA take?
• Are there concerns about the ability to comply with any of the
potential regulatory options?
• What advice do you have for reducing impacts on small
businesses?
• What timeframe would your business need to comply with
potential new regulations or restrictions?
U.S. Environmen^lJ|rotectiori Agency
75
-------
NMP Group 5: Consumer Uses
• Relevant condition of use:
- Consumer use in adhesives and sealants in glues and adhesives, including
lubricant adhesives and sealants
U.S. Environmental Protection Agency
-------
Potential Regulatory Options for NMP Group 5: Consumer
Uses
As noted previously EPA is considering the following regulatory options and is seeking your
feedback. Any regulatory requirement could be used alone or in combination to the extent
necessary so that NMP no longer presents an unreasonable risk under its conditions of use :
• Prohibition of manufacturing, processing or distribution of products for consumer use
• Concentration limit
• Regulatory options applied broadly with other restrictions
- Recordkeeping and downstream notification
- Monitoring and labeling
- Container size
U.S. Environmen^y^rotection Agency
77
-------
Discussion with Small Entity Representatives
Please provide your comments or questions regarding:
• Number and types of small entities affected
• Potential reporting, recordkeeping and compliance
requirements
• Related Federal rules
• Regulatory flexibility alternatives
U.S. Environmen^lJ^rotectiori Agency
-------
Discussion - Your Business and NMP
• How does your organization use NMP?
• Can you describe the specific use, as well as the workplace and workplace
setting where it is used?
• What is the trend of NMP use in your organization?
• How important to your business is the function that NMP provides?
• Are there potential critical or essential uses?
• Are there uses for which there are no available technically or economically
feasible alternatives?
-------
Discussion - Distributors and Retailers
• What is your experience with exposure control and risk reduction?
• If you could no longer sell products containing NMP, how would this impact your
business?
• Are there particular challenges to small business doing distribution of products
containing NMP that are different from large distributors?
• What is your preferred method of downstream notification?
• If you were required to limit sales of NMP containing products to only persons
who were certified to purchase it, what activities and costs would be involved?
What guidance would be helpful from the Agency?
U.S. Environmen^y^rotection Agency 80
-------
Discussion - Regulatory Options
• What regulatory approach should EPA take?
• Are there concerns about the ability to comply with any of the
potential regulatory options?
• What advice do you have for reducing impacts on small
businesses?
• What timeframe would your business need to comply with
potential new regulations or restrictions?
U.S. Environmen^lJ^rotectiori Agency
81
-------
Closing Session
• Closing remarks from EPA, SBA, and OMB
• Next steps
- Written comments by April 11, 2023
- The risk evaluation and supplemental materials are in docket EPA-
HQ-OPPT-2019-0236, with additional materials supporting the risk
evaluation process and the revised unreasonable risk determination
in docket EPA-HQ-OPPT-2016-0743, on www.requlations.gov
U.S. Environmen^y^rotectiori Agency
-------
Additional Information
• General TSCA: https://www.epa.aov/assessina-and-manaaina-chemicals-under-tsca/frank-r-
lautenbera-chemical-safetv-21st-centurv-act
• Current Chemical Risk Management Activities: https://www.epa.gov/assessina-and-manaaing-
¦ -J. •:.; =.-5c -;: ^ y„ -\
chemicals-under-tsca/current-chemical-risk-management-activities
• NMP Risk Management: https://www.epa.gov/assessing-and-managing-chemicals-under-
tsca/risk-management-n-methvlpvrrolidone-nmp
• June 2021 Policy Changes: https://www.epa.gov/newsreleases/epa-announces-path-forward-
tsca-chemical-risk-evaluations
• NMP: Clara Hull (Hull.Clara@epa.gov. 202-564-3954)
U.S. Environment^protection Agency
83
-------
Contact Information
• EPA SBAR contact: Lanelle Wiggins (Wiqqins.Lanelle@epa.gov)
• EPA NMP: Clara Hull (Hull.0 ara@epa.gov)
• SBA Advocacy: Tabby Zeb ( "avvaba.Zeb@sba.gov)
• OMB OIRA: Austin Mudd (Austin.B.Mudd@omb.eop.gov)
U.S. Environment^protection Agency
-------
Appendix
• Pre-Panel Outreach SER Questions for Discussion (separate document)
• Related Regulations (EPA, other Federal, state, and international)
(separate document)
• Industry Sectors with Small Entities Potentially Affected by the
Rulemaking (separate document)
• Personal Protective Equipment Respirator System Per Worker Unit Cost
Breakdown (separate document)
• Example: OSHA Respiratory Protection Table (Slide 86)
• Dermal Personal Protective Equipment Unit Cost (Slide 87)
U.S. Environment^protection Agency
85
-------
Example: OSHA Respiratory Protection Table
Minimum Requirements for Respiratory Protection for Airborne Methylene Chloride
Methylene Chloride Airborne
Concentration (ppm) or Condition of Use
Minimum Respirator Required
Continuous flow suppiied-air respirator, hood, or helmet
(1) Full facepiece supplied-air respirator operated in negative-pressure
(demand) mode
(2) Fuil facepiece self-contained breathing apparatus (SCBA) operated in
negative-pressure (demand) mode
(1) Continuous flow supplied-air respirator, full facepiece
(2) Pressure demand supplied-air respirator, full facepiece
(3) Positive-pressure full facepiece SCBA
(1) Positive-pressure full facepiece SCBA
(2) Full facepiece pressure (demand) supplied-air respirator with an
auxiliary self-contained air supply
Up to 625 ppm (25 X PEL)
Up to 1,250 ppm (50 X PEL)
Up to 5,000 ppm (200 X PEL)
Unknown concentration, or above 5,000
ppm (Greater than 200 X PEL)
Firefighting
Positive-pressure full facepiece SCBA
Emergency Escape
(1) Any continuous flow or pressure-demand SCBA
(2) Gas mask with organic vapor canister
https://www.osha.gov/sites/default/files/publicatiQris/osha3144.pdf
-------
Dermal Personal Protective Equipment Unit Cost
Glove Material
Butyl
Natural Rubber/Latex
Neoprene
Laminated Polyethylene
Nitrile
Apron Material
Polyethylene
Neoprene
Nitrile
Type
Reusable
Reusable
Reusable
Reusable
Disposable
Average Price Per Useful Life (pairs
Pair (2021$)
$54.53
$6.16
$11.25
$7.48
$0.56
per year)
4
4
4
4
260
Type
Disposable
Reusable
Reusable
Average Price per Useful Life (per
Apron (2021$) year)
$3.64 260
$33.87 4
$25.13 4
U.S. Environment^ gptection Agency
87
-------
Industry Sectors with Small Entities Potentially Affected by the Rule
AM 05
-------
EPA's SBAR Pre-Panel Outreach Meeting with Small Entity Representatives on Proposed
Rulemaking for n-Methylpyrrolidone (NMP) under TSCA Section 6(a)
Industry Sectors with Small Entities Potentially Affected by the Rulemaking
Entities potentially regulated by this rulemaking to address the unreasonable risks from NMP include
those entities relevant to the conditions of use of NMP that EPA evaluated, including domestic
manufacturing, import, processing uses of NMP, repackaging and recycling, industrial and commercial
uses of NMP (such as solvents for cleaning or degreasing, adhesives and sealants, lubricants and greases,
paints and coatings, and in a variety of cleaning products), consumer uses (including adhesives and
sealants), and disposal. Entities may include manufacturers (including importers), processors,
formulators, industrial and commercial users, or distributors (such as retailers) of NMP or products
containing NMP within the scope of this rulemaking.
Potentially affected entities will include both employer and non-employer firms and establishments
identified within these sectors by the U.S. Census for each applicable North American Industry
Classification System (NAICS) code. Since the Small Business Administration (SBA) size standard varies by
NAICS code, they are also included in the table below. NAICS codes of potentially affected entities may
include but are not limited to those in Table 1 below. Table 2 shows the estimated number of small firms
by condition of use (COU).
Table 1: Potentially Affected Entities
NAICS
NAICS Description
SBA Size Standard
236115
New Single-family Housing Construction (Except For-Sale Builders)
$45.0 million
236116
New Multifamily Housing Construction (except For-Sale Builders)
$45.0 million
236117
New Housing For-Sale Builders
$45.0 million
236118
Residential Remodelers
$45.0 million
236210
Industrial Building Construction
$45.0 million
236220
Commercial and Institutional Building Construction
$45.0 million
237110
Water and Sewer Line and Related Structures Construction
$45.0 million
237120
Oil and Gas Pipeline and Related Structures Construction
$45.0 million
237130
Power and Communication Line and Related Structures Construction
$45.0 million
237310
Highway, Street, and Bridge Construction
$45.0 million
237990
Other Heavy and Civil Engineering Construction
$45.0 million
238110
Poured Concrete Foundation and Structure Contractors
$19.0 million
238120
Structural Steel and Precast Concrete Contractors
$19.0 million
238130
Framing Contractors
$19.0 million
238190
Other Foundation, Structure, and Building Exterior Contractors
$19.0 million
238210
Electrical Contractors and Other Wiring Installation Contractors
$19.0 million
238220
Plumbing, Heating, and Air-Conditioning Contractors
$19.0 million
238290
Other Building Equipment Contractors
$22.0 million
238310
Drywall and Insulation Contractors
$19.0 million
238320
Painting and Wall Covering Contractors
$19.0 million
238330
Flooring Contractors
$19.0 million
238910
Site Preparation Contractors
$19.0 million
238990
All Other Specialty Trade Contractors
$19.0 million
313210
Broadwoven Fabric Mills
1,000 employees
AM 08
-------
EPA's SBAR Pre-Panel Outreach Meeting with Small Entity Representatives on Proposed
Rulemaking for n-Methylpyrrolidone (NMP) under TSCA Section 6(a)
NAICS
NAICS Description
SBASize Standard
313320
Fabric Coating Mills
1,000 employees
316110
Leather and Hide Tanning and Finishing
500 employees
316210
Footwear Manufacturing
1,000 employees
321912
Cut Stock, Resawing Lumber, and Planing
500 employees
322220
Paper Bag and Coated and Treated Paper Manufacturing
750 employees
323111
Commercial Printing (except Screen and Books)
500 employees
323113
Commercial Screen Printing
500 employees
323117
Books Printing
1,250 employees
323120
Support Activities for Printing
500 employees
324110
Petroleum Refineries
1,500 employees
324191
Petroleum Lubricating Oil and Grease Manufacturing
750 employees
325110
Petrochemical Manufacturing
1,000 employees
325120
Industrial Gas Manufacturing
1,000 employees
325180
Other Basic Inorganic Chemical Manufacturing
1,000 employees
325199
All Other Basic Organic Chemical Manufacturing
1,250 employees
325199
All Other Basic Organic Chemical Manufacturing
1,250 employees
325211
Plastics Material And Resin Manufacturing
1,250 employees
325220
Artificial and Synthetic Fibers and Filaments Manufacturing
1,000 employees
325320
Pesticide and Other Agricultural Chemical Manufacturing
1,000 employees
325412
Pharmaceutical Preparation Manufacturing
1,250 employees
325510
Paint And Coating Manufacturing
1,000 employees
325520
Adhesive Manufacturing
500 employees
325611
Soap And Other Detergent Manufacturing
1,000 employees
325612
Polish and Other Sanitation Good Manufacturing
750 employees
325612
Polish and Other Sanitation Good Manufacturing
750 employees
All Other Miscellaneous Chemical Product And Preparation
325998
Manufacturing
500 employees
326150
Urethane and Other Foam Product (except Polystyrene) Manufacturing
750 employees
326199
All Other Plastics Product Manufacturing
750 employees
327390
Other Concrete Product Manufacturing
500 employees
327910
Abrasive Product Manufacturing
750 employees
331110
Iron and Steel Mills and Ferroalloy Manufacturing
1,500 employees
331210
Iron and Steel Pipe and Tube Manufacturing from Purchased Steel
1,000 employees
331221
Rolled Steel Shape Manufacturing
1,000 employees
331222
Steel Wire Drawing
1,000 employees
331313
Alumina Refining and Primary Aluminum Production
1,000 employees
331314
Secondary Smelting and Alloying of Aluminum
750 employees
331315
Aluminum Sheet, Plate, and Foil Manufacturing
1,250 employees
331318
Other Aluminum Rolling, Drawing, and Extruding
750 employees
331410
Nonferrous Metal (except Aluminum) Smelting and Refining
1,000 employees
331420
Copper Rolling, Drawing, Extruding, and Alloying
1,000 employees
Nonferrous Metal (except Copper and Aluminum) Rolling, Drawing, and
331491
Extruding
750 employees
AM 07
-------
EPA's SBAR Pre-Panel Outreach Meeting with Small Entity Representatives on Proposed
Rulemaking for n-Methylpyrrolidone (NMP) under TSCA Section 6(a)
NAICS
NAICS Description
SBASize Standard
Secondary Smelting, Refining, and Alloying of Nonferrous Metal
331492
(except Copper and Aluminum)
750 employees
331511
Iron Foundries
1,000 employees
331512
Steel Investment Foundries
1,000 employees
331513
Steel Foundries (except Investment)
500 employees
331523
Nonferrous Metal Die-Casting Foundries
500 employees
331524
Aluminum Foundries (except Die-Casting)
500 employees
331529
Other Nonferrous Metal Foundries (except Die-Casting)
500 employees
332111
Iron and Steel Forging
750 employees
332112
Nonferrous Forging
750 employees
332114
Custom Roll Forming
500 employees
332117
Powder Metallurgy Part Manufacturing
500 employees
332119
Metal Crown, Closure, and Other Metal Stamping (except Automotive)
500 employees
Metal Kitchen Cookware, Utensil, Cutlery, and Flatware (except
332215
Precious) Manufacturing
750 employees
332216
Saw Blade and Handtool Manufacturing
750 employees
332311
Prefabricated Metal Building and Component Manufacturing
750 employees
332312
Fabricated Structural Metal Manufacturing
500 employees
332313
Plate Work Manufacturing
750 employees
332321
Metal Window and Door Manufacturing
750 employees
332322
Sheet Metal Work Manufacturing
500 employees
332323
Ornamental and Architectural Metal Work Manufacturing
500 employees
332410
Power Boiler and Heat Exchanger Manufacturing
750 employees
332420
Metal Tank (Heavy Gauge) Manufacturing
750 employees
332431
Metal Can Manufacturing
1,500 employees
332439
Other Metal Container Manufacturing
500 employees
332510
Hardware Manufacturing
750 employees
332613
Spring Manufacturing
500 employees
332618
Other Fabricated Wire Product Manufacturing
500 employees
332710
Machine Shops
500 employees
332721
Precision Turned Product Manufacturing
500 employees
332722
Bolt, Nut, Screw, Rivet, and Washer Manufacturing
500 employees
332811
Metal Heat Treating
750 employees
Metal Coating, Engraving (except Jewelry and Silverware), and Allied
332812
Services to Manufacturers
500 employees
332813
Electroplating, Plating, Polishing, Anodizing, and Coloring
500 employees
332911
Industrial Valve Manufacturing
750 employees
332912
Fluid Power Valve and Hose Fitting Manufacturing
1,000 employees
332913
Plumbing Fixture Fitting and Trim Manufacturing
1,000 employees
332919
Other Metal Valve and Pipe Fitting Manufacturing
750 employees
332991
Ball and Roller Bearing Manufacturing
1,250 employees
332992
Small Arms Ammunition Manufacturing
1,250 employees
332993
Ammunition (except Small Arms) Manufacturing
1,500 employees
A1 -108
-------
EPA's SBAR Pre-Panel Outreach Meeting with Small Entity Representatives on Proposed
Rulemaking for n-Methylpyrrolidone (NMP) under TSCA Section 6(a)
NAICS
NAICS Description
SBASize Standard
332994
Small Arms, Ordnance, and Ordnance Accessories Manufacturing
1,000 employees
332996
Fabricated Pipe and Pipe Fitting Manufacturing
500 employees
332999
All Other Miscellaneous Fabricated Metal Product Manufacturing
750 employees
333111
Farm Machinery and Equipment Manufacturing
1,250 employees
Lawn and Garden Tractor and Home Lawn and Garden Equipment
333112
Manufacturing
1,500 employees
333120
Construction Machinery Manufacturing
1,250 employees
333131
Mining Machinery and Equipment Manufacturing
500 employees
333132
Oil and Gas Field Machinery and Equipment Manufacturing
1,250 employees
333241
Food Product Machinery Manufacturing
500 employees
333242
Semiconductor Machinery Manufacturing
1,500 employees
333243
Sawmill, Woodworking, and Paper Machinery Manufacturing
500 employees
Industrial and Commercial Fan and Blower and Air Purification
333413
Equipment Manufacturing
500 employees
333414
Heating Equipment (except Warm Air Furnaces) Manufacturing
500 employees
Air-Conditioning and Warm Air Heating Equipment and Commercial
333415
and Industrial Refrigeration Equipment Manufacturing
1,250 employees
333511
Industrial Mold Manufacturing
500 employees
333514
Special Die and Tool, Die Set, Jig, and Fixture Manufacturing
500 employees
333515
Cutting Tool and Machine Tool Accessory Manufacturing
500 employees
333517
Machine Tool Manufacturing
500 employees
333519
Rolling Mill and Other Metalworking Machinery Manufacturing
500 employees
333611
Turbine and Turbine Generator Set Units Manufacturing
1,500 employees
333612
Speed Changer, Industrial High-Speed Drive, and Gear Manufacturing
750 employees
333613
Mechanical Power Transmission Equipment Manufacturing
750 employees
333618
Other Engine Equipment Manufacturing
1,500 employees
333912
Air and Gas Compressor Manufacturing
1,000 employees
333914
Measuring, Dispensing, and Other Pumping Equipment Manufacturing
750 employees
333921
Elevator and Moving Stairway Manufacturing
1,000 employees
333922
Conveyor and Conveying Equipment Manufacturing
500 employees
333923
Overhead Traveling Crane, Hoist, and Monorail System Manufacturing
1,250 employees
333924
Industrial Truck, Tractor, Trailer, and Stacker Machinery Manufacturing
750 employees
333991
Power-Driven Handtool Manufacturing
500 employees
333992
Welding and Soldering Equipment Manufacturing
1,250 employees
333993
Packaging Machinery Manufacturing
500 employees
333994
Industrial Process Furnace and Oven Manufacturing
500 employees
333995
Fluid Power Cylinder and Actuator Manufacturing
750 employees
333996
Fluid Power Pump and Motor Manufacturing
1,250 employees
334111
Electronic Computer Manufacturing
1,250 employees
334112
Computer Storage Device Manufacturing
1,250 employees
Computer Terminal and Other Computer Peripheral Equipment
334118
Manufacturing
1,000 employees
334210
Telephone Apparatus Manufacturing
1,250 employees
A1-109
-------
EPA's SBAR Pre-Panel Outreach Meeting with Small Entity Representatives on Proposed
Rulemaking for n-Methylpyrrolidone (NMP) under TSCA Section 6(a)
NAICS
NAICS Description
SBASize Standard
Radio and Television Broadcasting and Wireless Communications
334220
Equipment Manufacturing
1,250 employees
334290
Other Communications Equipment Manufacturing
750 employees
334310
Audio and Video Equipment Manufacturing
750 employees
334413
Semiconductor And Related Device Manufacturing
1,250 employees
334510
Electromedical and Electrotherapeutic Apparatus Manufacturing
1,250 employees
Search, Detection, Navigation, Guidance, Aeronautical, and Nautical
334511
System and Instrument Manufacturing
1,250 employees
Automatic Environmental Control Manufacturing for Residential,
334512
Commercial, and Appliance Use
500 employees
Instruments and Related Products Manufacturing for Measuring,
334513
Displaying, and Controlling Industrial Process Variables
750 employees
334514
Totalizing Fluid Meter and Counting Device Manufacturing
750 employees
Instrument Manufacturing for Measuring and Testing Electricity and
334515
Electrical Signals
750 employees
334516
Analytical Laboratory Instrument Manufacturing
1,000 employees
334517
Irradiation Apparatus Manufacturing
1,000 employees
334519
Other Measuring and Controlling Device Manufacturing
500 employees
335210
Small Electrical Appliance Manufacturing
1,500 employees
335220
Major Household Appliance Manufacturing
1,500 employees
335311
Power, Distribution, and Specialty Transformer Manufacturing
750 employees
335312
Motor and Generator Manufacturing
1,250 employees
335313
Switchgear and Switchboard Apparatus Manufacturing
1,250 employees
335314
Relay and Industrial Control Manufacturing
750 employees
335921
Fiber Optic Cable Manufacturing
1,000 employees
335929
Other Communication and Energy Wire Manufacturing
1,000 employees
335931
Current-Carrying Wiring Device Manufacturing
500 employees
335932
Noncurrent-Carrying Wiring Device Manufacturing
1,000 employees
335991
Carbon and Graphite Product Manufacturing
750 employees
All Other Miscellaneous Electrical Equipment and Component
335999
Manufacturing
500 employees
336120
Heavy Duty Truck Manufacturing
1,500 employees
336211
Motor Vehicle Body Manufacturing
1,000 employees
336212
Truck Trailer Manufacturing
1,000 employees
336213
Motor Home Manufacturing
1,250 employees
336214
Travel Trailer and Camper Manufacturing
1,000 employees
336310
Motor Vehicle Gasoline Engine and Engine Parts Manufacturing
1,000 employees
336320
Motor Vehicle Electrical and Electronic Equipment Manufacturing
1,000 employees
Motor Vehicle Steering and Suspension Components (except Spring)
336330
Manufacturing
1,000 employees
336340
Motor Vehicle Brake System Manufacturing
1,250 employees
336350
Motor Vehicle Transmission and Power Train Parts Manufacturing
1,500 employees
336360
Motor Vehicle Seating and Interior Trim Manufacturing
1,500 employees
A1-110
-------
EPA's SBAR Pre-Panel Outreach Meeting with Small Entity Representatives on Proposed
Rulemaking for n-Methylpyrrolidone (NMP) under TSCA Section 6(a)
NAICS
NAICS Description
SBASize Standard
336370
Motor Vehicle Metal Stamping
1,000 employees
336390
Other Motor Vehicle Parts Manufacturing
1,000 employees
336411
Aircraft Manufacturing
1,500 employees
336412
Aircraft Engine and Engine Parts Manufacturing
1,500 employees
336413
Other Aircraft Parts and Auxiliary Equipment Manufacturing
1,250 employees
336413
Other Aircraft Part and Auxiliary Equipment Manufacturing7
1,250 employees
336414
Guided Missile and Space Vehicle Manufacturing
1,250 employees
Guided Missile and Space Vehicle Propulsion Unit and Propulsion Unit
336415
Parts Manufacturing
1,250 employees
Other Guided Missile and Space Vehicle Parts and Auxiliary Equipment
336419
Manufacturing
1,000 employees
336510
Railroad Rolling Stock Manufacturing
1,500 employees
337110
Wood Kitchen Cabinet and Counter Top Manufacturing
750 employees
337122
Nonupholstered Wood Household Furniture Manufacturing
750 employees
339112
Surgical and Medical Instrument Manufacturing
1,000 employees
339113
Surgical Appliance and Supplies Manufacturing
750 employees
339114
Dental Equipment and Supplies Manufacturing
750 employees
339115
Ophthalmic Goods Manufacturing
1,000 employees
339116
Dental Laboratories
500 employees
339950
Sign Manufacturing
500 employees
339999
All Other Miscellaneous Manufacturing
500 employees
423120
Motor Vehicle Supplies and New Parts Merchange Wholesalers
200 employees
423220
Home Furnishing Merchant Wholesalers
100 employees
423330
Roofing, Siding, and Insulation Material Merchant Wholesalers
225 employees
423390
Other Construction Material Merchant Wholesalers
100 employees
423490
Other Professional Equipment and Supplies Merchant Wholesalers
150 employees
Electrical Apparatus and Equipment, Wiring Supplies, and Related
423610
Equipment Merchant Wholesalers
200 employees
Electrical And Electronic Appliance, Television, And Radio Set Merchant
423620
Wholesalers
225 employees
423840
Industrial Supplies Merchant Wholesalers
125 employees
423850
Service Establishment Equipment and Supplies Merchant Wholesalers
125 employees
424690
Other Chemical And Allied Products Merchant Wholesalers
175 employees
424710
Petroleum Bulk Stations and Terminals
225 employees
Petroleum and Petroleum Products Merchant Wholesalers (except Bulk
424720
Stations and Terminals)
200 employees
441110
Automobile Dealers
200 employees
441110
New Car Dealers
200 employees
441120
Used Car Dealers
$30.5 million
488410
Motor Vehicle Towing
$9.0 million
531190
Lessors of Other Real Estate Property9
$34.0 million
541330
Engineering Services
$25.5 million
541380
Testing Laboratories
$19.0 million
A1-111
-------
EPA's SBAR Pre-Panel Outreach Meeting with Small Entity Representatives on Proposed
Rulemaking for n-Methylpyrrolidone (NMP) under TSCA Section 6(a)
NAICS
NAICS Description
SBASize Standard
561110
Office Administrative Services
$12.5 million
561210
Facilities Support Services
$47.0 million
561720
Janitorial Services
$22.0 million
561740
Carpet and Upholstery Cleaning Services
$8.5 million
562211
Hazardous Waste Treatment and Disposal
$47.0 million
562212
Solid Waste Landfill
$47.0 million
562213
Solid Waste Combustors and Incinerators
$47.0 million
562219
Other Nonhazardous Waste Treatment and Disposal
$47.0 million
562920
Materials Recovery Facilities
$25.0 million
711510
Independent Artists, Writers, and Performers
$9.0 million
712110
Museums
$34.0 million
811111
General Automotive Repair
$9.0 million
811121
Automotive Body, Paint, and Interior Repair and Maintenance
$9.0 million
811121
Automotive Body, Paint and Interior Repair and Maintenance
$9.0 million
811122
Automotive Glass Replacement Shops
$17.5 million
811191
Automotive Oil Change and Lubrication Shops
$11.0 million
811192
Car Washes
$9.0 million
811198
All Other Automotive Repair and Maintenance
$10.0 million
811412
Appliance Repair and Maintenance
$19.0 million
811420
Reupholstery and Furniture Repair
$9.0 million
811430
Footwear and Leather Goods Repair
$9.0 million
811490
Other Personal and Household Goods Repair and Maintenance
$9.0 million
812310
Coin-Operated Laundries and Drycleaners
$13.0 million
812320
Drycleaning and Laundry Services (except Coin-Operated)
$8.0 million
812331
Linen Supply
$40.0 million
812332
Industrial Launderers
$47.0 million
Source: U.S. Small Business Administration Table of Small Business Size Standards Available at:
https://www. sba.gov/document/suDDort-table-size-standards
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Rulemaking for n-Methylpyrrolidone (NMP) under TSCA Section 6(a)
Table 2: Small Entities Potentially Affected
Use Category
Estimated
Number of
Firms Using
NMP
Percent of
Firms That
Are Small
Estimated
Number of
Small Firms
Using NMP
Manufacture/Import
49
24%
12
Repackaging
32
95%
30
Processing: incorporation into a formulation, mixture
or reaction product
66
62%
41
Lithium ion battery manufacturing
55
87%
48
Waste handling, disposal, treatment, and recycling
1,787
91%
1,624
Plastic and resin product manufacturing
983
94%
922
Textiles, leather, and apparel manufacturing
33
95%
31
Processing aids in petrochemical manufacturing, oil
and gas activities, and functional fluids (closed
systems)
479
89%
428
Laboratory use
56
93%
51
Paints and coatings
13,574
97%
13,202
Paint, coating, and adhesive removers
4,296
91%
3,903
Electronic product and semiconductor manufacturing
3,473
94%
3,279
Adhesives and sealants
7,012
97%
6,816
Cleaning and furniture care products
2,702
99%
2,667
Ink, toner, and colorant products
114
99%
113
Soldering
2,768
98%
2,715
Fertilizer and other agricultural chemical
manufacturing
9
90%
8
Lubricants and lubricant additives
-
-
-
Anti-freeze and de-icing
-
-
-
Total
37,488
96%
35,892
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Related Regulations (ERA, Federal, State, and International)
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EPA's SBAR Pre-Panel Outreach Meeting with Small Entity Representatives on Proposed
Rulemaking for n-methylpyrrolidone (NMP) under TSCA Section 6(a)
Related Regulations (EPA, Federal, State, and International)
Table 1 - EPA Regulations
Si a 1 ii 1 es/Uegu la lions
Description of
Aiilhorily/Uegulalion
Description of Regulation
EPA Statutes/Regulations
Toxic Substances
Control Act (TSCA) -
Section 6(a)
Provides EPA with the authority to
prohibit or limit the manufacture
(including import), processing,
distribution in commerce, use or
disposal of a chemical if EPA
evaluates the risk and concludes
that the chemical presents an
unreasonable risk to human health
or the environment.
Proposed rule under section 6 of
TSCA to address the unreasonable
risk presented by NMP in paint and
coating removal (8!
January 19, 2017) The NMP portion
of the proposed rule was withdrawn
in 2021 (86 FR 3932. Januarv 15.
2021).
Toxic Substances
Control Act (TSCA) -
Section 6(b)
Directs EPA to promulgate
regulations to establish processes
for prioritizing chemical
substances and conducting risk
evaluations on priority chemical
substances. In the meantime, EPA
was required to identify and begin
risk evaluations on 10 chemical
substances drawn from the 2014
update of the TSCA Work Plan for
Chemical Assessments.
NMP is on the initial list of 10
chemical substances to be evaluated
for unreasonable risk of injury to
health or the environment (81 FR
91927, December 19, 2016)
Toxic Substances
Control Act (TSCA) -
Section8(a)
The TSCA Section 8(a) Chemical
Data Reporting (CDR) Rule
requires manufacturers (including
importers) to give EPA basic
exposure-related information on
the types, quantities and uses of
chemical substances produced
domestically and imported into the
US.
NMP manufacturing, importing,
processing and use information is
reported under the CDR rule (76 FR
50816, August 16, 2011).
Toxic Substances
Control Act (TSCA) -
Section8(b)
EPA must compile, keep current
and publish a list (the TSCA
Inventory) of each chemical
substance manufactured,
processed, or imported in the
United States.
NMP was on the initial TSCA
Inventory and therefore was not
subject to EPA's new chemicals
review process (60 FR 16309,
March 29, 1995).
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EPA's SBAR Pre-Panel Outreach Meeting with Small Entity Representatives on Proposed
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Si a 1 ii 1 es/Uegu la lions
Description of
Aiilhorily/Uegulalion
Description of Regulation
Toxic SubsUiiKvs
Control Act (TSCA) -
Section 8(e)
Maiuil'acUiivis (including
importers), processors and
distributors must immediately
notify EPA if they obtain
information that supports the
conclusion that a chemical
substance or mixture presents a
substantial risk of injury to health
or the environment.
Sc\cn nolilicalions of subslanlial
risk (Section 8(e)) received (2007 -
2010) (US EPA. ChemView.
Accessed April 13, 2017).
Toxic Substances
Control Act (TSCA) -
Section 4
Provides EPA with authority to
issue rules and orders requiring
manufacturers (including
importers) and processors to test
chemical substances and mixtures.
Six submissions from a test rule
(Section 4) received in the mid-
1990s. (US EPA. ChemView.
Accessed April 13, 2017).
Emergency Planning
and Community Right-
To-Know Act
(EPCRA)-Section 313
Requires annual reporting from
facilities in specific industry
sectors that employ 10 or more full
time equivalent employees and
that manufacture, process, or
otherwise use a TRI-listed
chemical in quantities above
threshold levels. A facility that
meets reporting requirements must
submit a reporting form for each
chemical for which it triggered
reporting, providing data across a
variety of categories, including
activities and uses of the chemical,
releases and other waste
management (e.g., quantities
recycled, treated, combusted) and
pollution prevention activities
(under Section 6607 of the
Pollution Prevention Act). This
data includes on-site and off-site
data as well as multimedia data
(i.e., air, land and water).
NMP is a listed substance subject to
reporting requirements under 40
CFR 372.65 effective as of January
1, 1995.
Federal Food, Drug and
Cosmetic Act (FFDCA)
- Section 408
FFDCA governs the allowable
residues of pesticides in food.
Section 408 of the FFDCA
provides EPA with the authority to
set tolerances (rules that establish
NMP is currently approved for use
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
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EPA's SBAR Pre-Panel Outreach Meeting with Small Entity Representatives on Proposed
Rulemaking for n-methylpyrrolidone (NMP) under TSCA Section 6(a)
Si a 1 ii 1 es/Uegu la lions
Description of
Aiilhorily/Uegulalion
Description of Regulation
maximum allowable residue
limits), or exemptions from the
requirement of a tolerance, for all
residues of a pesticide (including
both active and inert ingredients)
that are in or on food. Prior to
issuing a tolerance or exemption
from tolerance, EPA must
determine that the tolerance or
exemption is "safe." Sections
408(b) and (c) of the FFDCA
define "safe" to mean the Agency
has a reasonable certainty that no
harm will result from aggregate
exposures to the pesticide residue,
including all dietary exposure and
all other exposure (e.g., non-
occupational exposures) for which
there is reliable information.
Pesticide tolerances or exemptions
from tolerance that do not meet the
FFDCA safety standard are subject
to revocation. In the absence of a
tolerance or an exemption from
tolerance, a food containing a
pesticide residue is considered
adulterated and may not be
distributed in interstate commerce.
tolerance limit (40 CFR Part
180.920).
Clean Air Act (CAA) -
Section 111 (b)
Requires EPA to establish new
source performance standards
(NSPS) for any category of new or
modified stationary sources that
EPA determines causes, or
contributes significantly to, air
pollution which may reasonably be
anticipated to endanger public
health or welfare. The standards
are based on the degree of
emission limitation achievable
through the application of the best
system of emission reduction
which (considering the cost of
achieving reductions and non-air
NMP is subject to CAA Section 111
Standards of Performance for New
Stationary Sources of Air Pollutants
for volatile organic compound
(VOC) emissions from synthetic
organic chemical manufacturing
industry distillation operations (40
CFR Part 60, subpart NNN) and
reactor processes (40 CFR Part 60,
Subpart RRR). This rule applies
only to sources constructed after
1983 and includes the production of
NMP. EPA expects that facilities
included in the risk evaluation
already meet this standard.
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Rulemaking for n-methylpyrrolidone (NMP) under TSCA Section 6(a)
Si a 1 ii 1 es/Uegu la lions
Description of
Aiilhorily/Uegulalion
Description of Regulation
quality health and environmental
impacts and energy requirements)
EPA determines has been
adequately demonstrated.
Clean Air Act (CAA) -
Section 183(e)
Section 183(e) requires EPA to list
the categories of consumer and
commercial products that account
for at least 80 percent of all VOC
emissions in areas that violate the
National Ambient Air Quality
Standards for ozone and to issue
standards for these categories that
require "best available
controls." In lieu of regulations,
EPA may issue control techniques
guidelines if the guidelines are
determined to be substantially as
effective as regulations.
NMP is listed under the National
Volatile Organic Compound
Emission Standards for Aerosol
Coatings (40 CFR part 59, subpart
E). This is a content-based limit
confined to manufacturers of aerosol
coating products.
Clean Air Act (CAA) -
Section 612
Under Section 612 of the CAA,
EPA's Significant New
Alternatives Policy (SNAP)
program reviews substitutes for
ozone depleting substances within
a comparative risk framework.
EPA publishes lists of acceptable
and unacceptable alternatives. A
determination that an alternative is
unacceptable, or acceptable only
with conditions, is made through
rulemaking.
Under EPA's SNAP program, EPA
listed NMP as an acceptable
substitute for "straight organic
solvent cleaning (with terpenes,
C620 petroleum hydrocarbons,
oxygenated organic solvents such as
ketones, esters, alcohols, etc.)" for
metals, electronics and precision
cleaning and "Oxygenated organic
solvents (esters, ethers, alcohols,
ketones)" for aerosol solvents (59
FR, March 18, 1994).
Safe Drinking Water
Act (SDWA) - Section
1412 (b)
Every 5 years, EPA must publish a
list of contaminants (1) that are
currently unregulated, (2) that are
known or anticipated to occur in
public water systems, and (3)
which might require regulations
under SDWA. EPA must also
determine whether to regulate at
least five contaminants from the
list every 5 years.
NMP was identified on both the
Third (2009) and Fourth (2016)
Contaminant Candidate Lists (74 FR
51850, October 8, 2009) (81 FR
81099 November 17, 2016).
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EPA's SBAR Pre-Panel Outreach Meeting with Small Entity Representatives on Proposed
Rulemaking for n-methylpyrrolidone (NMP) under TSCA Section 6(a)
Table 2 - Other Federal Regulations
Matiilcs/Ucgulalions
Description of Aiilhorily/Ucgiilalion
Description of Regulation
Other Federal Statutes/Regulations
Occupational Safety
and Health Act
(OSHA)
Requires employers to provide their
workers with a place of employment free
from recognized hazards to safety and
health, such as exposure to toxic
chemicals, excessive noise levels,
mechanical dangers, heat or cold stress,
or unsanitary conditions.
Under the Act, OSHA can issue
occupational safety and health standards
including such provisions as Permissible
Exposure Limits (PELs), exposure
monitoring, engineering and
administrative control measures and
respiratory protection.
OSHA has not established a
PEL for NMP.
Federal Food, Drug
and Cosmetic Act
(FFDCA)
Provides the U.S Food and Drug
Administration (FDA) with authority to
oversee the safety of food, drugs and
cosmetics.
Food and Drug
Administration identifies
NMP as an "Indirect Additive
Used in Food Contact
Substances" specifically as:
1) an adjuvant substance in
the preparation of slimicides
(21 CFR 176.300),
2) an adjuvant substance in
the production of polysulfone
resin authorized for use as
articles intended for use in
contact with food (21 CFR
177.1655) and
3) a residual solvent in
polyetherone sulfone resins
authorized as articles for
repeated use in contact with
food (21 CFR 177.2440).
FDA also identifies NMP as a
Class 2 solvent, namely a
solvent that "should be limited
in pharmaceutical products
because of their inherent
toxicity."
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EPA's SBAR Pre-Panel Outreach Meeting with Small Entity Representatives on Proposed
Rulemaking for n-methylpyrrolidone (NMP) under TSCA Section 6(a)
Si a 1 ii 1 es/Uegu la lions
Description of Authority/Regulation
Description of Regulation
FDA established a
Permissible Daily Exposure
(PDE) for NMP of 5.3 mg/day
with a concentration limit of
530 ppm.
FDA's Center for Veterinary
Medicine developed a method
in 2011 for detection of the
residues of NMP in edible
tissues of cattle (21 CFR
500.1410)
Federal Hazardous
Material
Transportation Act
Section 5103 of the Act directs the
Secretary of Transportation to: Designate
material (including an explosive,
radioactive material, infectious
substance, flammable or combustible
liquid, solid or gas, toxic, oxidizing or
corrosive material and compressed gas)
as hazardous when the Secretary
determines that transporting the material
in commerce may pose an unreasonable
risk to health and safety or property.
Issue regulations for the safe
transportation, including security of
hazardous material in intrastate,
interstate and foreign commerce.
The Department of
Transportation (DOT) has
designated NMP as a
hazardous material, and there
are special requirements for
marking, labeling and
transporting it (49 CFR Part
171, 49 CFR 172, 40 CFR §
173.202 and 40 CFR §
173.242.
Table 3 - State Laws and Regulations
State Actions
Description of Action
State Air
Regulations
New Hampshire (Env-A 1400: Regulated Toxic Air Pollutants) lists NMP as
a regulated toxic air pollutant.
Vermont (Vermont Air Pollution Control Regulations, 5261) lists NMP as a
hazardous air contaminant.
Chemicals of
Concern to
Children
Several states have adopted reporting laws for chemicals in children's
products that include NMP including Oregon (OAR 333-016-2000), Vermont
(18 V.S.A. Sections 1771 to 1779) and Washington state (WAC 173-334-
130). Minnesota has listed NMP as a chemical of concern to children
(Minnesota Statutes 116.9401 to 116.9407).
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EPA's SBAR Pre-Panel Outreach Meeting with Small Entity Representatives on Proposed
Rulemaking for n-methylpyrrolidone (NMP) under TSCA Section 6(a)
State Actions
Description of Action
State
Permissible
Exposure
Limits
California PEL is 1 ppm as an 8hr TWA, along with a skin notation (Cal
Code Regs, title 8, Section 5155).
State Right-to-
Know Acts
Massachusetts (454 CMR 21.00), New Jersey (42 N.J.R. 1709(a)) and
Pennsylvania (Chapter 323. Hazardous Substance List).
Other
In California, NMP is listed on Proposition 65 (Cal. Code Regs. Title 27,
Section 27001) due to reproductive toxicity. California OEHHA lists a
Maximum Allowable Dose Level (MADL) for inhalation exposure =
3,200 |ig/day MADL for dermal exposure = 17,000 |ig/day.
The California Department of Toxic Substances Control (DTSC) Safer
Consumer Products Program lists NMP as a Candidate Chemical for
development toxicity and reproductive toxicity. In addition, DTSC is moving
to address paint strippers containing NMP and specifically cautioned against
replacing methylene chloride with NMP. In August 2018 the California
DTSC Safer Consumer Products program proposed to list Paint and Varnish
Strippers and Graffiti Removers Containing NMP as a priority product citing
(1) potential for human and other organism exposure to NMP in paint and
varnish strippers and graffiti removers; and (2) the exposure has the potential
to contribute to or cause significant or widespread adverse impacts. DTSC
published a Product-Chemical Profile for Paint and Varnish Strippers and
Graffiti Removers Containing NMP to support the listina. California
Department of Public Health's Hazard Evaluation System and Information
Service (HESIS) issued a Health Hazard Advisory on NMP in 2006 and
updated the Advisory in June 2014. The Advisory is aimed at workers and
employers at sites where NMP is used.
Table 4 - International Laws and Regulations
Country/Organization
Requirements and Restrictions
European Union
In 2011, NMP was listed on the Candidate list as a Substance of
Very High Concern (SVHC) under regulation (EC) No 1907/2006 -
REACH.
In March 2017, NMP was included in the public consultation of
chemicals recommended for inclusion in Annex XIV of the ECHA
under Annex (Authorisation list) of regulation (EC) No 1907/2006
- REACH.
In 2013. the Netherlands submitted a proposal under REACH to
restrict manufacturing and all industrial and professional uses of
NMP where workers' exposure exceeds a level specified in the
restriction ECHA database. Accessed November 4, 2022).
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EPA's SBAR Pre-Panel Outreach Meeting with Small Entity Representatives on Proposed
Rulemaking for n-methylpyrrolidone (NMP) under TSCA Section 6(a)
Country/Organi/ation
Requirements and Restrictions
On April 18. 2018. the European Union added NMP to REACH
Annex \ \ h. the restricted substances list. The action specifies
three conditions of restriction. The conditions are: 1) NMP shall not
be placed on the market as a substance on its own or in mixtures in
concentrations greater than 0.3% after May 9, 2020, unless
manufacturers, importers and downstream users have included
chemical safety reports and SDSs with Derived No-Effect Levels
(DNELs) relating to workers' exposures of 14,4 mg/m3 for exposure
by inhalation and 4,8 mg/kg/day for dermal exposure; 2) NMP shall
not be manufactured, or used, as a substance on its own or in
mixtures in a concentration equal to or greater than 0.3% after May
9, 2020 unless manufacturers and downstream users take the
appropriate risk management measures and provide the appropriate
operational conditions to ensure that exposure of workers is below
the DNELs specified above: and 3) the restrictions above shall
apply from May 9, 2024 to placing on the market for use, or use, as
a solvent or reactant in the process of coating wires.
Australia
NMP was assessed under Human Health Tier III of the Inventory
Multi-tiered Assessment and Prioritisation (IMAP) (National
Industrial Chemicals Notification and Assessment Scheme,
NICNAS, 2017, Human Health Tier III assessment for 2-
Pyrrolidinone, 1 methyl-. Accessed April, 18 2017).
Japan
NMP is regulated in Japan under the following legislation:
• Act on the Evaluation of Chemical Substances and
Regulation of their Manufacture, etc. (Chemical Substances
Control Law)
• Industrial Safety and Health Act
(National Institute of Technology and Evaluation (NITE) Chemical
Risk Information Platform (CHIRP). Accessed April 18, 2017).
European Union and
Australia, Austria,
Belgium, Canada
(Ontario), Denmark,
Finland, France,
Germany, Ireland, Italy,
Latvia, New Zealand,
Poland, Spain, Sweden,
Switzerland, The
Netherlands, Turkey and
the United Kingdom.
Occupational exposure limits (OELs) for NMP can be found by
searching for CAS No. 872-50-4, or N-Methyl-2-pyrrolidon, at
GESTIS International limit values for chemical agents (OELs)
database. Accessed April 18. 2017.
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SER Questions for Discussion
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EPA's SBAR Pre-Panel Outreach Meeting with Small Entity Representatives on Proposed
Rulemaking for n-Methylpyrrolidone (NMP) under TSCA Section 6(a)
Pre-Panel Outreach Small Entity Representative (SER) Questions for Discussion on NMP
For rules that may have a significant economic impact on a substantial number of small entities,
the Regulatory Flexibility Act (RFA) requires agencies to evaluate regulatory alternatives that
may minimize the burden on small entities expected to be regulated. The RFA notes that the
regulatory alternatives must be consistent with the stated objectives of applicable statutes (i.e.,
TSCA), and suggests significant alternatives such as:
the establishment of differing compliance or reporting requirements or timetables that
take into account the resources available to small entities;
the clarification, consolidation, or simplification of compliance and reporting
requirements under the rule for such small entities;
the use of performance rather than design standards; and
an exemption from coverage of the rule, or any part thereof, for such small entities.
To that end, these informal questions on your work practices and your experiences with n-
methylpyrrolidone (NMP) are aimed at guiding our discussion today, and your later written
feedback, towards ideas for minimizing the economic impact on your business while remaining
within the constraints of TSCA. We are not seeking a structured response on each question;
rather, we are interested in any feedback or details you can provide, and hope that these
questions let you know what type of information would be most useful as we consider advice
from the small entity representatives concerning TSCA regulation of NMP.
If you are interested in providing this or other information in writing, please see the contact
information below.
We ask that you refrain from providing Confidential Business information (CBI) during
the discussion or in email to EPA. If you choose to provide CBI, we will provide special
instructions.
Contact Information:
Lanelle Wiggins
Office of Regulatory Policy and Management
Office of Policy
Phone: (202) 566-2372
E-mail: wiggins.lanelle@epa.gov
1) Your business (All SERs)
a. How does your organization use NMP? How much NMP does your organization use?
b. Does your organization still use NMP? What is the trend of use? For example, has your
organization increased use of NMP? Has use remained constant? Is use decreasing? Is
your organization phasing out the use of NMP?
c. Can you describe the specific use, as well as the workplace and workplace setting where
NMP is used?
d. Why does your organization use NMP? What function does NMP provide?
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e. Where is your organization in the supply chain? (e.g., are you a processor - formulating
another product with NMP, a distributor, or final user of NMP in an application?) Do you
provide finished product to another small entity or to a large entity?
f. For what industries or applications do you provide products or services for? (e.g.,
aerospace, electronics, military, automotive, optics, museums/art restorations, academic,
commercial laboratory, consumers, other) Can you provide NAICs code(s) for the
products/services you provide?
g. For what process are you using NMP? (can be more than one, such as cleaning, drying,
inspection, etc.)
h. If NMP were not available, how would you adjust and what would the impacts be on
your business? What specific barriers would your business face in switching to an
alternative?
i. What are the benefits to your business of NMP? Are there specific benefits for small
businesses using NMP as compared to benefits for larger businesses?
j. If the concentration of NMP in a product was limited, would this impact the efficacy of
the product and/or increase the duration of use or exposure? For which particular uses?
2) Workplace exposure (All SERs)
a. How many employees, and what fraction of your employees, are exposed to NMP, and
for how long (days/year and hours/day)?
b. If you use a product containing NMP, what product do you use and what is the
concentration of NMP in the product?
c. What work activities result in worker exposure to NMP? And what type of exposure
(dermal, inhalation)?
d. For each activity, in what physical state and concentration is NMP?
e. Have you taken industrial hygiene monitoring data? If so, what was typical and high-end
exposure to NMP?
f. How do you measure whether and how much dermal exposure workers experience?
i. How are workers informed about potential dermal or inhalation exposure to NMP
ii. If workers experience an accidental exposure what procedures are followed?
g. What engineering controls are used to minimize exposure to NMP? How effective are
those controls?
i. Would it be feasible to use additional engineering controls to minimize exposure to
NMP? If so, what might those engineering controls be?
ii. What is your experience with equipment changes to reduce exposure or cross-
examination?
h. What administrative controls and training do you use to minimize exposure to NMP? Do
you use training to minimize exposure to NMP?
i. Is personal protective equipment (PPE) is regularly worn by workers to minimize
exposure to NMP?
i. If yes, could you provide more information regarding the type of PPE that is used?
And would it be feasible to use PPE that provided a level of protection beyond what
U.S. Environmental Protection Agency
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you are already using? Do you have experience with air supplied respirators? Do
you have experience with other respirators, or glove PPE?
ii. If no, would it be feasible to have workers wear PPE to minimize their exposure to
NMP? And what PPE would be feasible for workers to wear? Are there workers or
processes where the use of PPE would be impractical?
j. How many employees are located in the same room where the work activities related to
NMP are taking place but not necessarily handling NMP or NMP-containing products?
k. If applicable, what do you do to comply with Cal/OSHA standards for NMP?
1. If outside of California, what measures or specifications do you measure to for workplace
safety?
3) Regulatory options (All SERs)
a. Which of the regulatory options presented today would you recommend?
b. Cost estimates: In your experience, are the cost estimates reasonably representative? Do
you have additional information to improve the cost estimates?
c. What indirect costs to your organization do you estimate would occur as a result of this
regulation?
d. Recognizing that the cost estimates are only partial unit costs, can you provide any
additional information on potential costs or cost considerations the Agency should
consider when evaluating the costs of complying with potential regulatory options?
e. Can you think of ways to add flexibility to this rulemaking for your small businesses?
f. Are there other alternative regulatory options that the agency should consider to manage
the unreasonable risk identified for NMP?
g. How do you learn about EPA regulations and what you should do to comply?
h. What kind of additional information or resources would help you understand the
regulations and steps necessary to comply?
i. What is the best way to reach out to members of your industry?
j. Is there additional information on potential costs or cost considerations the Agency
should consider when evaluating the costs of complying with potential regulatory
options?
4) Additional questions for formulators of products containing NMP: substitutes and
alternatives
a. Product reformulation:
i. How often do you reformulate your products?
ii. What is the typical cost of reformulating your products?
iii. What might reformulation costs be if you needed to reformulate your products
without NMP? (e.g., costs associated with research and development, testing,
capital costs of production changes, packaging, labeling)
b. Product relabeling:
i. How often do you relabel your products?
ii. What is the typical cost of relabeling?
c. Alternatives:
U.S. Environmental Protection Agency
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i. Do you sell another product that does not contain NMP that is designed for the
same use or application as the NMP product?
If yes:
• What solvent replaces NMP in the alternative product?
• How does the alternative product compare in terms of safety, efficacy, and
cost?
If no:
• If you need to reformulate this product with a lower concentration of
NMP, what would be the implications for the product in terms of cost and
efficacy?
• If you need to reformulate this product without NMP, what solvent would
replace NMP in the alternative product? How do you think the alternative
product would compare in terms of efficacy and cost?
ii. Is there a subset of uses for your product where using a product formulated without
NMP would be problematic?
iii. Are there differences between products intended for consumer or commercial use
(such as formulation, labeling, container size)?
5) Additional questions for NMP in commercial and consumer formulations:
a. What type of formulations do you use with NMP? In soldering, paints and coatings, inks,
paint and coating removers, or other formulations?
b. Current work practices:
i. Is this NMP formulation applied through a system (closed pipe or transfer
lines, heated recapture systems) or handheld applications (as an aerosol,
brush, or dip application)?
ii. What type of items do you apply the NMP formulation too?
iii. Is there a difference in commercial versus consumer grade product?
c. Current work practices:
i. How significant is this NMP formulation to your business overall? Does this
use seem representative of most small businesses?
ii. When do you use NMP in the process flow in your facility, are you using
other processes as well? For example, do you do aqueous cleaning in addition
to cleaning with NMP? Does aqueous cleaning happen before or after NMP
formulations are used?
d. How significant is this NMP formulation to your business overall? Does this use seem
representative of most small businesses?
6) Additional questions for users of products containing NMP: substitutes and alternatives
a. What chemicals or processes have you considered as an alternative to using NMP or a
product containing NMP? Why? How do these chemicals or processes compare to
current uses containing NMP? More specifically:
i. Do you currently use any alternatives to NMP (or product)?
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ii. Did you try to switch to another chemical, product, or process only to switch back?
What were the results? If so, what did you switch to, why did you switch back, and
what made you switch in the first place?
iii. If you have tried or switched to alternative chemicals or methods, how did they do?
how long did that process take? Did it require equipment modifications or new
equipment purchases?
iv. Is there any difference in terms of operation time for alternative products or
processes to you NMP formulation? For example, between a graffiti remover
containing NMP versus a cold cleaning process.
v. What are the relative advantages and disadvantages of different substitutes and/or
processes that you have considered, including in terms of exposure, cost, and
hazard?
vi. Provide specific information related to each substitute chemical, product, or process
related to the use of alternative chemicals/products and compare to NMP:
Identification of alternative chemical/product/process
How much of the alternative product/chemical would be needed to perform
same activity?
Capital costs including new equipment, retrofitting of old equipment, etc. of
using the alternative chemical/process, loss of use of existing equipment
- Number of workers required, amount of worker time required
- Number of workers exposed
Costs associated with transitioning to the alternative chemical (e.g.,
identifying and testing the alternative chemical/process, certifying or
otherwise ensuring customer or other required production standards are met,
production downtime during the transition, lost productivity while learning
how to use the alternative efficiently)
Process changes required (e.g., additional time to complete task, additional
steps, etc.)
Energy and other resource (e.g., water) usage
Other operation and maintenance costs (e.g., filters, tank cleanings, etc.)
Changes in production or output of operation
Releases of alternative chemicals/products
Waste and disposal costs associated with alternative chemical/process
Changes in your product/service quality
Training, medical surveillance, or other employee-related costs
Recordkeeping burden/costs
Monitoring and testing costs
Potential barriers/concerns with switching to alternatives
vii. Have you considered similar solvents like l-ethyl-2-pyrrolidone (NEP), or other
non-halogenated solvents or aqueous processes?
viii. Are you using NMP on some but not all products? If you use NMP or a substitute,
how did you decide which to use?
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If you have tried or switched to alternative chemicals or methods, how did
they do? how long did that process take? Did it require equipment
modifications or new equipment purchases?
Is there any difference in terms of operation time for alternative products or
processes to you NMP formulation? For example, between a graffiti remover
containing NMP versus a cold cleaning process.
ix. If NMP formulations could no longer be used for your use, or required to be used
at a lower concentration:
At what concentration of NMP is your formulation no longer effective?
Would the mix of alternative chemicals/methods be different for you as a
small businesses compared to larger businesses? For example, are there
particular alternatives that are more suitable for small businesses?
x. If you had to change your cleaning process to another somewhat similar solvent
like a NEP blend, can you give an estimate of costs?
Use equipment
Process development
Process verification and validation (including lab testing and/or third-party
verification), i.e., proving to yourself that the process works
Customer certification
Training
Insurance
Permitting
Facilities changes
Documentation
PPE requirements
xi. What if you needed to move your use to a different process like aqueous or
another non-similar solvent (modified alcohols, hydrocarbons, alcohols, other
blends)? Can you give an estimate of costs?
Use equipment
Process development
Process verification and validation (including lab testing and/or third-party
verification) (i.e., proving to yourself that the process works))
Customer certification
Training
Insurance
Permitting
Facilities changes
Documentation
PPE requirements
xii. If there is no technically and economically feasible alternative for NMP available
for your use, what are some consequences/impacts that your business may
experience?
xiii. What would be the cost to your business if your use of NMP was prohibited?
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7) Additional questions for electronics manufacturing, including capacitor, resistor, coil,
transformer, and other inductor manufacturing; semiconductor manufacturing;
lithium-ion cell manufacturing:
a. Facility information:
i. How long have you owned or worked at the electronics manufacturing facility?
ii. What is the status of your business (i.e., independently owned, family operation,
chain operation, or franchise)?
iii. What's the facility size in square feet and height? Who are your nearest neighbors
(e.g., residence, business, school, hospital, other)? Is your facility co-residential or
co-commercial?
iv. Do you have an industrial hygiene system in the electronics manufacturing
facility? If so, what type of exposure controls are implemented (e.g., restricted
access, pneumatic tools, enclosed machines, wall fan, powered exhaust ceiling
fan, non-powered exhaust ceiling fan, open door, open window, vapor barrier
room around the machine, or local ventilation system such as a fume hood or
shroud over machine)?
b. Work practices related to electronics manufacturing operations:
i. How many employees work at your electronics manufacturing operation full
time? Part time?
ii. How many days a week/year are you open? What are your operating hours?
iii. What is the location of your equipment (i.e., is it in a separate room, close to the
finishing equipment, etc.)?
b. Machine information:
i. Do you have a special model of machine? How many machines do you have?
ii. How much NMP do you purchase per month in gallons?
iii. How old is the equipment? When did you last update your system and what was
the nature of the update (e.g., new system/machinery, installation of emissions
devices, etc.)? What prompted this update?
iv. How often do you inspect the machine? What type of leak detector test do you
use?
c. Operating information:
i. From whom do you purchase your solvent or product containing NMP? How
much does it cost?
ii. How do you dispose of your waste (e.g., still bottoms, filter)?
d. Alternatives:
i. Why do you use NMP rather than other alternatives?
ii. Do you also use alternatives in addition to NMP? If so, what alternative do you
use?
iii. Are you using NMP on some but not all items? Are there items that you prefer to
use NMP on? If so, what items and why is NMP preferred?
iv. How did you decide which solvent to use?
e. If NMP could no longer be used for electronics manufacturing, would the mix of
alternative cleaning methods be different for you as a small business compared to larger
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businesses? For example, are there particular alternatives that are more suitable for small
businesses?
f. Questions regarding electronics manufacturing as an industry:
i. How many electronic manufacturers in the U.S. use NMP? What percentage of
these manufacturers using NMP are small businesses?
ii. How much NMP is used in the U.S. for electronic manufacturing every year?
8) Additional questions for distributors and retailers (for consumer uses)
a. How much of your business is supplying products containing NMP to consumers? How
much of your business is supplying products containing NMP to commercial or industrial
users?
b. If you could no longer sell products containing NMP, how would this impact your
business?
c. Do you also sell products designed for the same application or use that do not contain
NMP?
i. If yes, what is the relative share of sales for the product(s) containing NMP
compared to the products that do not contain NMP?
d. Are there particular challenges to small business doing distribution of products
containing NMP that are different from large distributors? Please describe.
e. What is your preferred method of downstream notification?
f. If you were required to limit sales of NMP-containing products to only persons who were
certified to purchase it, what activities and costs would be involved? What guidance
would be helpful from the Agency? Please identify any challenges you see with such a
limitation.
g. If restrictions (e.g., prohibition or limit to concentration of NMP in products or articles)
were placed on NMP in products or articles, how long would you need to notify
downstream users? How long would it take to clear channels or trade?
h. If restriction (e.g., restricted container size for NMP-containing products) were placed on
NMP in products, what activities and costs would be involved in repackaging activities?
How long would it take to implement and to clear channels or trade?
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Personal Protective Equipment Respirator System Per Worker Unit Cost
Breakdown
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EPA's SBAR Pre-Panel Outreach Meeting with Small Entity Representatives on Proposed
Rulemaking for n-Methylpyrrolidone (NMP) under TSCA Section 6(a)
Personal Protective Equipment Respirator System Per Worker Unit Cost Breakdown
OSHA's Respiratory Protection Standard (29 CFR 1910.134)1 identifies several types of respirators and
their Assigned Protection Factors (APFs). The APF denotes the level of respiratory protection that a given
respirator is expected to provide employees. Table 1 presents example annualized unit costs estimates for
respirators, respirator system components, training, fit testing, and medical clearance. Written respirator
program and cleaning costs are not present in this table. Actual costs will vary for each rule depending on
the affected industry and the analytical timeframe. Useful lives define the schedule used to discount each
cost component before the estimates are annualized.
Respirators are organized by their corresponding APF. Unit cost estimates for individual respirator system
components and kits are based on price data collected from retailer websites. Price data are averaged for
component and kit unit cost estimates that incorporate the price of more than one product brand.
Table 1: Example Annualized PPE Unit Costs per Worker, by Respirator System in 2021$
Respirator System
Component
Unit Cost
Useful
Life
Annualized Unit
Costs1
3% 7%
APF Factor 10
APR, Half Mask
Half Mask, (APR)
$21.53
2
$11
$11
Cartridge Filters (APR)
$19.48
0.01
$1,825
$1,780
Training
$123.00
1
$115
$112
Qualitative Fit-Testing
$62.00
1
$58
$57
Medical Clearance
$104.00
21
$6
$8
Total
$2,016
$1,968
APF Factor 25
PAPR, Loose-Fitting
Facepiece
Loose-Fitting Facepiece (PAPR)
$56.60
3
$20
$20
Cartridge Filters (PAPR)
$12.37
0.02
$580
$565
PAPR System
$1,126.63
3
$398
$404
Breathing Tube
$57.93
3
$20
$21
Training
$245.00
1
$230
$224
Medical Clearance
$104.00
21
$6
$8
Total
$1,254
$1,242
Loose-Fitting Facepiece (PAPR)
$56.60
3
$20
$20
1 The Respiratory Protection Standard (29 CFR 1910.134), promulgated by OSHA, contains requirements for
program administration, procedures for respirator selection, employee training, fit testing, medical evaluation,
respirator use, APFs and Maximum Use Concentrations (MUCs), as well as other provisions.
1
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EPA's SBAR Pre-Panel Outreach Meeting with Small Entity Representatives on Proposed
Rulemaking for n-Methylpyrrolidone (NMP) under TSCA Section 6(a)
Respirator System
Component
Unit Cost
Useful
Life
Annualized Unit
Costs1
3% 7%
SAR, Continuous Flow
Mode, Loose-Fitting
Facepiece
Breathing Tube
$157.55
3
$56
$56
Pump
$976.52
7
$182
$195
Pump Installation
$53.45
7
$10
$11
Pump Inlet Filter
$8.33
0.48
$16
$16
Pump Outlet Filter
$14.07
0.19
$69
$68
Training
$245.00
1
$230
$224
Medical Clearance
$104.00
21
$6
$8
Total
$589
$598
APF Factor 50
APR, Full Facepiece
Full Facepiece (APR)
$236.14
2
$118
$117
Cartridge Filters (APR)
$19.48
0.01
$1,825
$1,780
Training
$123.00
1
$115
$112
Qualitative Fit-Testing
$62.00
1
$58
$57
Medical Clearance
$104.00
21
$6
$8
Total
$2,123
$2,075
PAPR, Half Mask
Half Mask
$21.53
3
$8
$8
Cartridge Filters (PAPR)
$12.37
0.02
$580
$565
PAPR System Components Kit
$1,126.63
3
$398
$404
Breathing Tube and Airline Hose
$57.93
3
$20
$21
Training
$245.00
1
$230
$224
Quantitative Fit-Testing
$144.00
1
$135
$132
Medical Clearance
$104.00
21
$6
$8
Total
$1,376
$1,361
SAR, Continuous Flow
Mode, Half Mask
Half Mask
$21.53
3
$8
$8
Breathing Tube
$157.55
3
$56
$56
Pump
$976.52
7
$182
$195
Pump Installation
$53.45
7
$10
$11
Pump Inlet Filter
$8.33
0.48
$16
$16
2
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EPA's SBAR Pre-Panel Outreach Meeting with Small Entity Representatives on Proposed
Rulemaking for n-Methylpyrrolidone (NMP) under TSCA Section 6(a)
Respirator System Component
Pump Outlet Filter
$14.07
0.19
$69
$68
Training
$245.00
1
$230
$224
Quantitative Fit-Testing
$144.00
1
$135
$132
Medical Clearance
$104.00
21
$6
$8
Total
$712
$717
APF Factor 1000
Full Facepiece
$194.14
3
$69
$70
PAPR System
$1,126.63
3
$398
$404
Breathing Tube
$57.93
3
$20
$21
PAPR, Full Facepiece
Cartridge Filters (PAPR)
$12.37
0.02
$580
$565
Training
$245.00
1
$230
$224
Quantitative Fit-Testing
$144.00
1
$135
$132
Medical Clearance
$104.00
21
$6
$8
Total
$1,437
$1,423
Hood
$96.02
3
$34
$34
PAPR System Components Kit
$1,126.63
3
$398
$404
Breathing Tube
$57.93
3
$20
$21
PAPR, Helmet/Flood
Cartridge Filters (PAPR)
$12.37
0.02
$580
$565
Training
$245.00
1
$230
$224
Quantitative Fit-Testing
$144.00
1
$135
$132
Medical Clearance
$104.00
21
$6
$8
Total
$1,403
$1,388
Full Facepiece
$194.14
3
$69
$70
Pump (1/4 HP)
$976.52
7
$182
$195
SAR, Continuous Flow
Mode, Full Facepiece
Breathing Tube and Airline Hose
$157.55
3
$56
$56
Pump Installation
$53.45
7
$10
$11
Pump Inlet Filter
$8.33
0.48
$16
$16
Pump Outlet Filter
$14.07
0.19
$69
$68
Useful
Life
Annualized Unit
Costs1
3
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EPA's SBAR Pre-Panel Outreach Meeting with Small Entity Representatives on Proposed
Rulemaking for n-Methylpyrrolidone (NMP) under TSCA Section 6(a)
Respirator System Component
Training
$245.00
1
$230
$224
Quantitative Fit-Testing
$144.00
1
$135
$132
Medical Clearance
$104.00
21
$6
$8
Total
$773
$779
Hood
$96.02
3
$34
$34
Pump (3/4 HP)
$1,055.77
7
$197
$211
Breathing Tube and Airline Hose
$157.55
3
$56
$56
Pump Installation
$53.45
7
$10
$11
SAR, Continuous Flow
Mode, Helmet/Hood
Pump Inlet Filter
$12.53
0.48
$24
$24
Pump Outlet Filter
$14.07
0.19
$69
$68
Training
$245.00
1
$230
$224
Quantitative Fit-Testing
$144.00
1
$135
$132
Medical Clearance
$104.00
21
$6
$8
Total
$761
$768
APF Factor 10000
Positive-pressure SCBA System
(includes full facepiece):
$2,431.38
3
$859
$871
Air Compressor
$5,776.86
16
$669
$766
SCBA, Positive-pressure
Mode, Full Facepiece
Training
$490.00
$459
$448
Quantitative Fit-Testing
$144.00
$135
$132
Medical Clearance
$104.00
$6
$8
Total
$2,128
$2,225
Positive-pressure SCBA system
(includes hood)
$2,660.77
3
$940
$953
Air Compressor
$5,776.86
16
$669
$766
SCBA, Positive-pressure
Mode, Helmet/Flood
Training
$490.00
1
$459
$448
Quantitative Fit-Testing
$144.00
1
$135
$132
Medical Clearance
$104.00
21
$6
$8
Total
$2,209
$2,308
Useful
Life
Annualized Unit
Costs1
4
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EPA's SBAR Pre-Panel Outreach Meeting with Small Entity Representatives on Proposed
Rulemaking for n-Methylpyrrolidone (NMP) under TSCA Section 6(a)
Respirator System
Component
Unit Cost
Useful
Life
Annualized Unit
Costs1
3% 7%
1 Costs are annualized over a 20-year time period
Acronyms
• APF: Assigned Protection Factors
• APR: Air-Purifying Respirator
• OSHA: Occupational Safety and Health Administration
• PARP: Powered Air-Purifying Respirator
• PPE: Personal Protective Equipment
• SAR: Supplied-Air Respirator (SAR) or Airline Respirator
• SCBA: Self-Contained Breathing Apparatus
5
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Potential Regulatory Options and Estimated Costs
AM 38
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EPA's SBAR Pre-Panel Outreach Meeting with Small Entity Representatives on Proposed
Rulemaking for n-Methylpyrrolidone (NMP) under TSCA Section 6(a)
Potential Regulatory Options and Estimated Costs
Any regulatory requirement could be used alone or in combination to the extent necessary so
that NMP no longer presents an unreasonable risk under its condition of use. Additionally, under
TSCA section 6(g), EPA may propose a time-limited exemption for specific conditions of use
provided certain criteria are met.1
When considering practicability and a reasonable transition period, EPA works to account for
various factors such as supply chains, availability of alternatives, and time neededfor
recertification, testing, and retrofitting. Any information on historical timelines from industry on
replacing chemicals in the past are especially helpful in determining a reasonable transition
period, along with the information mentioned in the previous sentence.
Unlike some of the other chemicals currently undergoing risk management under TSCA section
6, EPA is not considering an airborne concentration limit for NMP and is focusing on dermal
protection measures. The 2020 risk evaluation for NMP and revised unreasonable risk
determination found that the unreasonable risk of injury to human health is driven by direct
dermal contact with liquid NMP.
EPA has not made a decision at this point about what regulatory options to propose.
Nonetheless, EPA 's primary performance metric for eliminating the unreasonable risk of injury
to human health is to eliminate or reduce significantly direct dermal contact with NMP. EPA is
considering the following regulatory options and seeking feedback on the impacts of applying
one or more of the following regulatory options to address the unreasonable risk from NMP.
Concentration Limit
• A risk management option that would restrict the concentration or weight fraction within
the formulation.
o For example, if scientific analysis supported it, EPA could limit the percentage
amount of the chemical in the formulation if that percentage addressed the
unreasonable risk and the formulation was still efficacious,
o In the 2020 Risk Evaluation for NMP, EPA identified the expected weight
fraction of NMP in liquid products based on publicly available information,
public comments, and available products on the market. If ranges of NMP in
formulations were identified, EPA generally assessed the lower bound of the
range as the central tendency and the upper bound of the range as the high end.
¦ Example: EPA identified and assessed the commercial use of NMP in
paints, coatings, adhesives and sealants based on products with 2-53%
1 In order to propose an exemption under TSCA section 6(g), EPA must find that the specific condition of use is a
critical or essential use for which no technically and economically feasible safer alternative is available; compliance
with the rule would significantly disrupt the national economy, national security, or critical infrastructure; or the
specific condition of use, as compared to alternatives, provides a substantial benefit to health, the environment, or
public safety. In proposing the exemption, EPA must provide a time limit for the exemption; analyze the need for
the exemption and make the analysis public; and include interim conditions to protect health and the environment.
AM 39
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EPA's SBAR Pre-Panel Outreach Meeting with Small Entity Representatives on Proposed
Rulemaking for n-Methylpyrrolidone (NMP) under TSCA Section 6(a)
NMP. At the high-end concentrations, in the expected occupational
exposure scenarios, this condition of use drives the unreasonable risk.
¦ Example: EPA identified and assessed the commercial use of NMP in
metal finishing products with 60-90% NMP. At these concentrations, in
the expected occupational exposure scenarios, this condition of use drives
the unreasonable risk.
• There is uncertainty if lowering the concentration limit may impact efficacy of the
products. For a concentration or weight fraction limit to address the unreasonable risk, it
would need to be lower than those that drove the unreasonable risk in the risk evaluation.
Prescriptive Engineering Controls
• A risk management option that would reduce worker exposure by requiring specific
physical changes to the workplace to eliminate or reduce direct dermal contact.
o Examples: installing additional or different equipment, such as enclosed
transfer liquid lines, closed loop container systems or a laboratory type fume
hood, to reduce the exposure to the chemical.
• EPA's confidence that the unreasonable risk from NMP can be addressed is highest for
highly standardized and industrialized settings, such as where NMP is used in a closed-
loop system.
Prescriptive Administrative Controls
• A risk management option that would reduce worker exposure by requiring processes or
procedures in the workplace to eliminate or reduce direct dermal contact.
o Examples: Limit access to work areas (restricted areas) or confining
operations (enclosed areas)
Prescriptive PPE Controls
• A risk management option that would require the use of specific PPE to minimize
exposure. This may limit flexibility for the regulated entity.
o Some examples of potential PPE that could contribute to reducing the
unreasonable risk are listed separately in in Appendix F of the 2020 final risk
evaluation, as well as the Potential Costs of Regulatory Options table later in this
document.
• Requiring the use of dermal and inhalation PPE that provides an impervious barrier in
combination with a set concentration limit of NMP would allow more flexibility for
regulated entities to mitigate unreasonable risk.
• EPA anticipates that PPE would need to be combined with training and other controls in
order to address the unreasonable risk from NMP.
2
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EPA's SBAR Pre-Panel Outreach Meeting with Small Entity Representatives on Proposed
Rulemaking for n-Methylpyrrolidone (NMP) under TSCA Section 6(a)
Combination of Controls (non-prescriptive)
• A combination of risk management approaches for conditions of use where strict
industrial practices may already exist. Enables users to determine how to most effectively
separate, distance, physically remove, or isolate workers from direct handling of NMP or
from contact with equipment/materials for which NMP may exist based on what works
best for their workplace and the ability to combine prescriptive controls
• This approach would eliminate direct dermal contact in accordance with the Pollution
Prevention Act and NIOSH hierarchy of controls.
• This approach could also include engineering and administrative controls to reduce
exposure.
• If direct dermal contact could not be eliminated using elimination, substitution,
engineering controls, or administrative controls, EPA could require personal protective
equipment that provides an impervious barrier.
• Examples: Automation, barriers, or design of tools
Prohibition
• EPA could include prohibition on manufacturing, processing, distribution, use, or
disposal for specific conditions of use or the chemical as a whole.
o For example, alternatives to NMP in paint and coating removal include solvent-
based alternatives like n-ethylpyrrolidone (NEP), benzyl alcohol, and other
methyl acetate-based formulations, or process-based alternatives like heat and
sanding.
¦ https://dtsc.ca.gov/wp-content/uploads/sites/31/2019/09/Final-NMP-Paint-
Stripper-Graffiti-Remover_Profile.pdf
• EPA requests data and feedback about availability and viability of NMP alternatives,
testing and analysis that SERs have completed of potential alternatives, the cost impacts
of SERs switching to alternatives, and the overall impacts to SERs' businesses if NMP is
prohibited.
Regulate the Manufacturing, Processing, and/or Distribution
• A risk management option for industrial, commercial, and consumer conditions of use.
These authorities allow EPA to regulate at key points, including the manufacturing,
processing, and distribution in commerce of a chemical or product in the supply chain.
Regulatory options applied broadly with other restrictions
• Recordkeeping and downstream notification
o For example, EPA could require manufacturers, processors, and distributors to
provide downstream notification to help ensure regulatory information {i.e.,
prohibition) reaches all users in the supply chain,
o Additionally, as an example, EPA could require manufacturers, processors, and
distributors to maintain ordinary business records and an exposure control plan.
3
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EPA's SBAR Pre-Panel Outreach Meeting with Small Entity Representatives on Proposed
Rulemaking for n-Methylpyrrolidone (NMP) under TSCA Section 6(a)
• Monitoring, labeling, and container sizes -
o For monitoring, EPA could require initial or periodic monitoring of occupational
exposure or for concentration limits.
o For labeling, EPA could require that a prominent label be securely attached to
each container with specific directions, limitation, and precautions, or that
describes the health endpoints. EPA could also require labeling products to
indicate that they should not be used by consumers or to describe other regulatory
requirements.
o For container sizes, EPA could require a minimum or maximum container size
(e.g., 32 ounce container, 55 gallon drum) to reduce likelihood of purchase by
certain types of users (consumers or commercial users)
• Limited access program
o For example, restrict distribution of a chemical or product only to certain users,
under a limited access program that could require training and certification, or
restrict distribution only to users with certain equipment or type of facilities.
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EPA's SBAR Pre-Panel Outreach Meeting with Small Entity Representatives on Proposed
Rulemaking for n-Methylpyrrolidone (NMP) under TSCA Section 6(a)
Potential Costs of Regulatory Options
Type of Cost
Estimated Compliance
Cost
Notes
Prohibition of manufacturing,
processing, and distribution
Varies with condition of
use
Cost will vary by condition of use. Potential
activities could include changes in process and
equipment, costs of alternatives2, reformulation (see
below), and more. Requires input from potentially
regulated entities.
Prohibition of Use
Varies with condition of
use
Cost will vary by condition of use. Potential
activities could include changes in process and
equipment, costs of alternatives, reformulation (see
below), and more. Requires input from potentially
regulated entities.
Reformulation of product to
reduce NMP concentration
$17,000 per product
Costs reflect dilution reformulation approach.
Reformulation of product to
eliminate NMP concentration
$60,000-$ 102,000 per
product
Costs will vary by condition of use and will be
dependent on reformulation approach. Requires
input from potentially regulated entities.
Engineering/Administrative
Controls
Varies by control type
and needs of user
Requires input from potentially regulated entities
Personal Protective Equipment
(PPE) for NMP (respirators)
APF 10: $1,800
APF25: $1,300
APF 50: $1,700
APF 1000: $1,100
APF 10000: $2,000
Annualized costs are per person and include
purchase of equipment (including filters), training,
fit-testing, and medical clearance. The unit costs
include a written respiratory program and equipment
cleaning. Does not include existing PPE use nor PPE
replacement due to employee turn-over. Includes
both purified and supplied air respirators.
Personal Protective Equipment
(PPE) for NMP (dermal)
Reusable gloves: $6-$55
Disposable gloves: $0.50
Reusable apron: $25-$34
Disposable apron: $4
Reusable glove costs are per pair of butyl, laminated
polyethylene, neoprene, and natural rubber/latex
gloves. Disposable glove costs are per pair of nitrile
gloves. Disposable nitrile gloves are not used alone,
but in combination with the reusable gloves.
Reusable apron costs are per nitrile and neoprene
apron. Disposable apron costs are per polyethylene
apron.
2 TSCA section 6(c)(2)(C) requires EPA "... 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.. .to the extent practicable, whether technically and economically feasible alternatives that
benefit health or the environment, compared to the use so proposed to be prohibited or restricted, will be reasonably
available as a substitute when the proposed prohibition or other restriction takes effect."
5
A1 -143
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EPA's SBAR Pre-Panel Outreach Meeting with Small Entity Representatives on Proposed
Rulemaking for n-Methylpyrrolidone (NMP) under TSCA Section 6(a)
Type of Cost
Estimated Compliance
Cost
Notes
Combination of controls (non-
Annualized costs of
Non-prescriptive approach would likely include
prescriptive)
Exposure control plan:
development of an exposure control plan. Costs
$560-$630 per facility
include costs for conducting regular inspections, PPE
costs
program plan documentation, records of plan
$35 per worker costs
implementation, and records of dermal exposure.
Includes both per-facility and per-worker costs.
One-time costs of
Costs would depend on baseline PPE and dermal
Exposure control plan:
exposure control plan activities.
40 hours one time cost to
develop plan: $3,730 per
facility
4 hours annual cost for
regular inspections: $370
per facility per year
0.43 hours annual
recordkeeping: $40 per
facility per year
Costs of engineering
controls, monitoring, or
PPE varies by control
type and needs of user
See PPE costs for glove
and apron costs
Product Label or Warnings
$830- $8,900 per
Costs will vary by condition of use. Potential
product, one time cost
activities may include graphic design changes, plate
changes, discarded inventory, and labor.
Container Sizes
$9,500-$47,500 per
A change in container size would lead to costs at the
product, one time cost
lower end while a packaging material change would
likely result in costs at the higher end.
Substitute Products (average per
Varies with condition of
Would vary by price of NMP per ounce vs.
ounce)
use
substitutes, as well as the differences in efficacy of
the substitute products.
Substitute Methods
Varies by job labor rate
This will primarily be labor cost and cost of
alternative equipment.
Recordkeeping
$218-$340 per firm
Ongoing annual labor and material costs associated
with documentation of ordinary business records.
Downstream Notification
$121-$138per product.
Costs are per product and include labor and material
one time cost
costs to update a product's safety data sheet (SDS).
Limited Access Program
Varies with condition of
Would vary by type of requirements for certification
use and type of
and any distribution processes or restrictions already
distributor
in place.
6
A1 -144
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Information on Weight Fractions of NMP Evaluated in the 2020 Risk
Evaluation
A1 -145
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EPA's SBAR Pre-Panel Outreach Meeting with Small Entity Representatives on Proposed Rulemaking for n-methylpyrrolidone
(NMP) under TSCA Section 6(a)
Information on Weight Fractions of NMP Evaluated in the 2020 Risk Evaluation
EPA's 2020 Risk Evaluation for NMP is available at https://www.epa.gov/assessing-and-managing-chemicals-under-tsca/final-risk-
evaluation-n-methvlpvrrolidone-nmp. The table below provides a summary of weight fractions (concentrations) of NMP evaluated for each
condition of use (COU) and location of that information in the risk evaluation (the Occupational Exposure Scenario (OES) number is also the
relevant section of the Risk Evaluation).
To support the Risk Evaluation, EPA determined the weight fraction of NMP in various products through information provided in the reasonably
available literature, previous risk assessments, and the 2017 NMP Market Profile (ABT, 2017). This Market Profile was prepared in part by
searching Safety Data Sheets (SDSs) of products that contain NMP and compiling the associated name, use, vendor and NMP concentration
associated with each of these products. Where multiple data points for a given type of product (e.g., paints and coatings) were available, EPA
estimated exposures using the central tendency (50th percentile, or CT) and high-end (95th percentile, or HE) NMP concentrations.
Condition of I so (COl )-
Occnpiilioiiiil Kxposure
Scenario (OKS)
Weigh I l*Y:u'(ion
r.\;ilu;ilcd (CI ;md IIK)
Domestic manufacture
2.4.1.2.1
100%
Evaluated pure NMP. This COU drives the unreasonable
risk (acute and chronic worker exposure).
Manufacture: import
2.4.1.2.2
100%
Evaluated pure NMP. This COU drives the unreasonable
risk (acute and chronic worker exposure).
Processing: as a reactant or intermediate
in plastic material and resin
manufacturing and other non-
incorporative processing
2.4.1.2.3
100%
Evaluated pure NMP. This COU drives the unreasonable
risk (acute and chronic worker exposure).
Processing: incorporation into a
formulation, mixture or reaction product
in multiple industrial sectors
2.4.1.2.4
100%
Evaluated pure NMP. This COU drives the unreasonable
risk (acute and chronic worker exposure).
Processing: incorporation into articles in
lubricants and lubricant additives in
machinery manufacturing
2.4.1.2.5
60-90%
Evaluated a range of NMP weight fractions. This COU
drives the unreasonable risk (acute worker exposure at
the high end and chronic worker exposure at the central
tendency and high end).
A1 -146
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EPA's SBAR Pre-Panel Outreach Meeting with Small Entity Representatives on Proposed Rulemaking for n-methylpyrrolidone
(NMP) under TSCA Section 6(a)
Condition of I so (COl )-
Occnpiilioiiiil Kxposure
Scenario (OKS)
Weigh I l*Y:u'(ion
r.\;ilu;ilcd (CI ;md IIK)
Processing: incorporation into articles in
paint additives and coating additives not
described by other codes in
transportation equipment manufacturing
2.4.1.2.6
2-53%
Evaluated a range of NMP weight fractions. This COU
drives the unreasonable risk (acute and chronic worker
exposure at the high end).EPA used data from public
comments, literature, and the Use and Market Profile for
n-Methylpyrrolidone to determine the NMP weight
fraction.
Processing: incorporation into articles as
a solvent (which becomes part of product
formulation or mixture), including in
textiles, apparel and leather
manufacturing
2.4.1.2.4
100%
Evaluated pure NMP. This COU drives the unreasonable
risk (acute and chronic worker exposure).
Processing: incorporation into articles in
other sectors, including in plastic product
manufacturing
2.4.1.2.3
100%
Evaluated pure NMP. This COU drives the unreasonable
risk (acute and chronic worker exposure).
Processing: repackaging in wholesale
and retail trade
2.4.1.2.2
100%
Evaluated pure NMP. This COU drives the unreasonable
risk (acute and chronic worker exposure).
Processing: recycling
2.4.1.2.7
92-100%
Evaluated a range of NMP weight fractions. This COU
drives the unreasonable risk (acute and chronic worker
exposure).
Industrial and commercial use in paints,
coatings, and, adhesive removers
2.4.1.2.8
31-70%
Evaluated a range of NMP weight fractions. This COU
drives the unreasonable risk (acute worker exposure at
the high end, and chronic worker exposure at the central
tendency and high end). EPA used data from public
comments, literature sources, and the Use and Market
Profile for n-Methylpyrrolidone to determine the NMP
weight fraction.
A1 -147
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EPA's SBAR Pre-Panel Outreach Meeting with Small Entity Representatives on Proposed Rulemaking for n-methylpyrrolidone
(NMP) under TSCA Section 6(a)
Condition of I so (COl )-
Occnpiilioiiiil Kxposure
Scenario (OKS)
Weigh I l*Y:u'(ion
r.\;ilu;ilcd (CI ;md IIK)
Industrial and commercial use in paints
and coatings in lacquers, stains,
varnishes, primers and floor finishes, and
powder coatings, surface preparation
2.4.1.2.6
2-53%
Evaluated a range of NMP weight fractions. This COU
drives the unreasonable risk (acute worker exposure at
the high end, and chronic worker exposure at the central
tendency and high end). EPA used data from public
comments, literature, and the Use and Market Profile for
n-Methylpyrrolidone to determine the NMP weight
fraction.
Industrial and commercial use in paint
additives and coating additives not
described by other codes in computer
and electronic product manufacturing in
electronic parts manufacturing
2.4.1.2.9
60-100%
Evaluated a range of NMP weight fractions. This COU
drives the unreasonable risk (acute and chronic worker
exposure at the central tendency and high end). EPA used
data from public comments, literature, and the Use and
Market Profile for n-Methylpyrrolidone to determine the
NMP weight fraction.
Industrial and commercial use in paint
additives and coating additives not
described by other codes in computer
and electronic product manufacturing for
use in semiconductor manufacturing
2.4.1.2.10
Container handling, small
containers 60-75%
Container handling,
drums 50-75%
Fab worker 2.5-5%
Maintenance 50-100%
Waste truck loading 92%
Evaluated a range of NMP weight fractions. This COU
drives the unreasonable risk (acute worker exposure at
the high end in most tasks, and chronic worker exposure
at the central tendency and high end). EPA used data
from public comments, literature, and the Use and
Market Profile for n-Methylpyrrolidone to determine the
NMP weight fraction.
Industrial and commercial use in in paint
additives and coating additives not
described by other codes in several
manufacturing sectors
2.4.1.2.6
2-53%
Evaluated a range of NMP weight fractions. This COU
drives the unreasonable risk (acute and chronic worker
exposure at the high end). EPA used data from public
comments, literature, and the Use and Market Profile for
n-Methylpyrrolidone to determine the NMP weight
fraction.
A1 -148
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EPA's SBAR Pre-Panel Outreach Meeting with Small Entity Representatives on Proposed Rulemaking for n-methylpyrrolidone
(NMP) under TSCA Section 6(a)
Condition of I so (COl )-
Occnpiilioiiiil Kxposure
Scenario (OKS)
Weigh I l*Y:u'(ion
r.\;ilu;ilcd (CI ;md IIK)
Industrial and commercial use as a
solvent (for cleaning or degreasing) use
in electrical equipment, appliance and
component manufacturing
2.4.1.2.9
60-100%
Evaluated a range of NMP weight fractions. This COU
drives the unreasonable risk (acute worker exposure at
the high end, and chronic worker exposure at the central
tendency and high end). EPA used data from public
comments, literature, and the Use and Market Profile for
n-Methylpyrrolidone to determine the NMP weight
fraction.
Industrial and commercial use as a
solvent (for cleaning or degreasing) in
electrical equipment, appliance and
component manufacturing for use in
semiconductor manufacturing
2.4.1.2.10
Container handling, small
containers 60-75%
Evaluated a range of NMP weight fractions. This COU
drives the unreasonable risk (acute worker exposure at
the high end in most tasks, and chronic worker exposure
at the central tendency and high end). EPA used data
from public comments, literature, and the Use and
Market Profile for n-Methylpyrrolidone to determine the
NMP weight fraction.
Container handling,
drums 50-75%
Fab worker 2.5-5%
Maintenance 50-100%
Virgin NMP truck
loading 100%
Waste truck loading 92%
Industrial and commercial use in ink,
toner, and colorant products in printer
ink and inks in writing equipment
2.4.1.2.11
Printing 5-7%
Evaluated a range of NMP weight fractions. This COU
drives the unreasonable risk (chronic worker exposure at
the high end). EPA used data from public comments and
the Use and Market Profile for n-Methylpyrrolidone to
determine the NMP weight fraction.
Writing 10-20%
A1 -149
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EPA's SBAR Pre-Panel Outreach Meeting with Small Entity Representatives on Proposed Rulemaking for n-methylpyrrolidone
(NMP) under TSCA Section 6(a)
Condition of I so (COl )-
Occnpiilioiiiil Kxposure
Scenario (OF.S)
Weigh I l*Y:u'(ion
r.\;ilu;ilcd (CI ;md IIK)
Industrial and commercial use in
processing aids, specific to petroleum
production in petrochemical
manufacturing, in other uses in oil and
gas drilling, extraction and support
activities, and in functional fluids (closed
systems)
2.4.1.2.3
100%
Evaluated pure NMP. This COU drives the unreasonable
risk (acute and chronic worker exposure).
Industrial and commercial use in
adhesives and sealants including binding
agents, single component glues and
adhesives, including lubricant adhesives,
and two-component glues and adhesives
including some resins
2.4.1.2.6
2-53%
Evaluated a range of NMP weight fractions. This COU
drives the unreasonable risk (acute and chronic worker
exposure at the high end). EPA used data from public
comments, literature, and the Use and Market Profile for
n-Methylpyrrolidone to determine the NMP weight
fraction.
Industrial and commercial use in other
uses in soldering materials
2.4.1.2.12
1-2.5%
Evaluated a range of NMP weight fractions. This COU
drives the unreasonable risk (chronic worker exposure at
the high end). EPA used data from public comments,
literature, and the Use and Market Profile for n-
Methylpyrrolidone to determine the NMP weight
fraction.
Industrial and commercial use in other
uses in anti-freeze and de-icing products,
automotive care products, and lubricants
and greases
2.4.1.2.13
2.5-33%
Evaluated a range of NMP weight fractions. This COU
drives the unreasonable risk (acute and chronic worker
exposure at the high end). EPA used data from public
comments, literature, and the Use and Market Profile for
n-Methylpyrrolidone to determine the NMP weight
fraction.
Industrial and commercial use in other
uses in metal products not covered
elsewhere, and lubricant and lubricant
additives including hydrophilic coatings
2.4.1.2.5
60-90%
Evaluated a range of NMP weight fractions. This COU
drives the unreasonable risk (acute and chronic worker
exposure at the central tendency and high end).
AM 50
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EPA's SBAR Pre-Panel Outreach Meeting with Small Entity Representatives on Proposed Rulemaking for n-methylpyrrolidone
(NMP) under TSCA Section 6(a)
Condition of Use (COU)*
Occupational Exposure
Scenario (OES)
Weight Fraction
Evaluated (CT and HE)
Notes
Industrial and commercial use in other
uses in laboratory chemicals
2.4.1.2.14
100%
Evaluated pure NMP. This COU drives the unreasonable
risk (acute and chronic worker exposure).
Industrial and commercial uses in other
uses in lithium ion battery manufacturing
2.4.1.2.15
Container handling, small
containers 99-100%
Evaluated a range of NMP weight fractions. This COU
drives the unreasonable risk (acute worker exposure at
the high end in most tasks, and chronic worker exposure
at the central tendency and high end). EPA used data
from public comments, literature, and the Use and
Market Profile for n-Methylpyrrolidone to determine the
NMP weight fraction.
Container handling,
drums 60-100%
Cathode coating 60%
Cathode mixing 60%
Research and
development 60-100%
Miscellaneous additional
activities 60-100%
Industrial and commercial use in other
uses in cleaning and furniture care
products, including wood cleaners and
gasket removers
2.4.1.2.16
Dip cleaning 85-100%
Evaluated a range of NMP weight fractions. This COU
drives the unreasonable risk (acute and chronic worker
exposure at the central tendency and high end). EPA used
data from public comments, literature sources, and the
Use and Market Profile for n-Methylpyrrolidone to
determine the NMP weight fraction.
Spray/wipe cleaning 31-
99%
Industrial and commercial use in other
uses in fertilizer and other agricultural
chemical manufacturing, processing aids
and solvents
2.4.1.2.17
0.1-7%
Evaluated a range of NMP weight fractions. This COU
drives the unreasonable risk (chronic worker exposure at
the high end). EPA used data from public comments,
literature sources, and the Use and Market Profile for n-
Methylpyrrolidone to determine the NMP weight
fraction.
A1-151
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EPA's SBAR Pre-Panel Outreach Meeting with Small Entity Representatives on Proposed Rulemaking for n-methylpyrrolidone
(NMP) under TSCA Section 6(a)
Condition of I se (C ()l )-
()cciip:ilion:il Kxposure
Scenario (OKS)
Weight l-Yiiction
K\2ilu;iled (C I :md UK)
Consumer use in adhesives and sealants
in glues and adhesives, including
lubricant adhesives and sealants
2.4.2.5 Adhesives and
Sealants
0.77-85%
Evaluated a range of NMP weight fractions. This COU
drives the unreasonable risk (consumer exposure (acute
only) at the high intensity).
Disposal
2.4.1.2.7
92-100%
Evaluated a range of NMP weight fractions. This COU
drives the unreasonable risk (acute and chronic worker
exposure).
* This table includes only conditions of use identified as driving the unreasonable risk for NMP. As a result, several consumer conditions of use and
distribution in commerce are not listed in this table, but risk estimates are provided in the Risk Evaluation.
Reference
(2017). Use and Market Profile for N-methylpyrrolidone (NMP). (EPA-HQ-OPPT-2016-0743-0060). Prepared for: Economic and
Policy Analysis Branch Chemistry, Economics, and Sustainable Strategies Division, Office of Chemical Safety and Pollution
Prevention, U.S. Environmental Protection Agency, https://www.regiilations.gov/docuinent?D=EPA-HO-OPP 1"~201 o-O "43-0060.
A1-152
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Final Report of the Small Business Advocacy Review Panel on Toxic Substances Control Act (TSCA) Section
6(a) Rulemaking for N-Methylpyrrolidone (NMP)
App nil Materials Shared with Sni III'n fir • F >, iiresentatlv^ t> a* the
If i' ach Meeting, May
Table of Contents
Agenda A2-2
Rulemaking Presentation (updated from Pre-Panel version) A2-7
Industry Sectors with Small Entities Potentially Affected by the Rulemaking (updated from Pre-Panel
version) A2-101
Related Regulations (EPA, Federal, State, and International) A2-112
SER Questions for Discussion A2-113
Personal Protective Equipment Respirator System Per Worker Unit Cost Breakdown A2-114
Potential Regulatory Options and Estimated Costs (updated from Pre-Panel version) A2-115
Information on Weight Fractions of NMP Evaluated in the 2020 Risk Evaluation A2-123
Key Takeaways from Pre-Panel Outreach Meeting A2-124
Pesticide Inert Ingredients Interpretation TSCA and FIFRA A2-131
A2-1
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Agenda
A2-2
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EPA's SBAR Panel Outreach Meeting with Small Entity Representatives on
Proposed Rulemaking for n-Methylpyrrolidone (NMP) under TSCA Section 6(a)
May 24, 2023, 12:30pm-3:00pm, Eastern time zone
Agenda
12:30 Welcome and Opening Remarks
• Bill Nickerson (EPA Small Business Advocacy Chair / Office of Policy)
• Eileen Murphy (Division Director, Existing Chemicals Risk Management Division, EPA
Office of Chemical Safety and Pollution Prevention)
• Tayyaba Zeb (Small Business Administration, Office of Advocacy)
• Mike Ciccarone (Office of Management and Budget, Office of Information and
Regulatory Affairs)
12:45 SER Introductions
12:55 Presentation on Panel process (Bill Nickerson, EPA SB AC)
1:05 Presentation on proposed rulemaking for NMP under TSCA section 6(a) (Office of
Chemical Safety and Pollution Prevention)
• Consultations with Small Entity Representatives (SERs)
• Key takeaways from the Pre-panel outreach meeting
• Overview of the unreasonable risk determinations in the risk evaluation and the risk
management requirements under TSCA
• Overview of conditions of use in the rulemaking and basis for unreasonable risk
determination
• Section 6 risk management overview: EPA's authority to regulate occupational and
consumer risks, key "tools in the toolbox" for managing unreasonable risks
• Potential regulatory options
1:25 Discussion on conditions of use (COU) with unreasonable risk determinations. (See list at
endfor all conditions of use by group).
• Detailed description of NMP use
• Your experience with exposure control and risk reduction
• Possible risk management actions
• Cost associated with implementations
• Available alternatives
• Other implementation considerations
NMP COU Group 1: Manufacturers, Repackaging/Recycling, and Disposal
NMP COU Group 2: Commercial Processing and Formulation Uses
NMP - May 24, 2023
A2-3
1
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2:10 Break
2:20 Discussion (continued)
NMP COU Group 3: Industrial and Commercial Paint, Coating, and Solvent Uses
NMP COU Group 4: Industrial and Commercial Uses in Manufacturing of Electronic
Parts, Semiconductors, and Lithium Ion Batteries
NMP COU Group 5: Consumer Uses
2:45 Closing session
• Closing remarks from EPA, SBA, and OMB
• Wrap up and next steps (what to expect next)
3:00 Adjourn
NMP - May 24, 2023
A2-4
2
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Condition of Use Discussion Groups
Group 1: Manufacturing, Repackaging/Recycling, and Disposal
- Includes the following conditions of use:
• Manufacturing (domestic manufacture)
• Manufacturing (import)
• Processing: repackaging in wholesale and retail trade
• Processing: recycling
• Disposal
Group 2: Commercial Processing and Formulation Uses
- Includes the following conditions of use:
• Processing - as a reactant or intermediate in plastic material and resin manufacturing and
other non-incorporative processing
• Processing - Incorporation into a formulation, mixture or reaction product in multiple
industrial sectors
• Processing - Incorporation into articles in lubricants and lubricant additives in machinery
manufacturing
• Processing - Incorporation into articles as a solvent (which becomes part of a product
formulation or mixture) including in textiles, apparel and leather manufacturing
• Processing - Incorporation into articles in paint additives and coating additives not
described by other codes in transportation equipment manufacturing
• Processing - Incorporation into articles in other sectors, including in plastic product
manufacturing
Group 3: Industrial and Commercial Paint, Coating, and Solvent Uses
- Includes the following conditions of use:
• Industrial and commercial use in paints, coatings and adhesive removers
• Industrial and commercial use in paints and coatings in lacquers, stains, varnishes,
primers and floor finishes and powder coatings in surface preparation
• Industrial and commercial use in in paint additives and coating additives not described by
other codes in multiple manufacturing sectors
• Industrial and commercial use in ink, toner and colorant products in printer ink and inks
in writing equipment
• Industrial and commercial use in processing aids, specific to petroleum production in
petrochemical manufacturing, in other uses in oil and gas drilling, extraction and support
activities, and in functional fluids (closed systems)
• Industrial and commercial use in adhesives and sealants including binding agents, single
component glues and adhesives, including lubricant adhesives, and two-component glues
and adhesives including some resins
• Industrial and commercial use in other uses in soldering materials
NMP - May 24, 2023
A2-5
3
-------
• Industrial and commercial use in other uses in anti-freeze and de-icing products,
automotive care products, and lubricants and greases
• Industrial and commercial use in other uses in metal products not covered elsewhere, and
lubricant and lubricant additives including hydrophilic coatings
• Industrial and commercial use in other uses in laboratory chemicals
• Industrial and commercial use in other uses in cleaning and furniture care products,
including wood cleaners and gasket removers
• Industrial and commercial use in other uses in fertilizer and other agricultural chemical
manufacturing, processing aids and solvents
Group 4: Industrial and Commercial Uses in Manufacturing of Electronic Parts,
Semiconductors, and Lithium Ion Batteries
- Includes the following condition of use:
• Industrial and commercial use in paint additives and coating additives not described by
other codes in computer and electronic product manufacturing for use in semiconductor
manufacturing
• Industrial and commercial use in paint additives and coating additives not described by
other codes in computer and electronic product manufacturing in electronic parts
manufacturing
• Industrial and commercial use as a solvent (for cleaning or degreasing) in electrical
equipment, appliance and component manufacturing
• Industrial and commercial use as a solvent (for cleaning or degreasing) in electrical
equipment, appliance and component manufacturing for use in semiconductor
manufacturing
• Industrial and commercial uses in other uses in lithium ion battery manufacturing
Group 5: Consumer Use
- Includes the following condition of use:
• Consumer use in adhesives and sealants in glues and adhesives, including lubricant
adhesives and sealants
NMP - May 24, 2023
A2-6
4
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Rulemaking Presentation (updated from Pre-Panel version)
A2-7
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N-Methylpyrrolidone (NMP)
Small Entity Consultation
Proposed Rulemaking under TSCA Section 6
Office of Pollution Prevention and Toxics
U.S. Environmental Protection Agency
Small Business Representative Panel Outreach Meeting
May 24, 2023
A2-8
-------
Overview
• SERs and the regulatory process
• Key Takeaways from Pre-Panel Outreach Meeting
• Findings from the risk evaluation for NMP
• Overview of conditions of use (COU) in the rulemaking
• Basis for unreasonable risk determination
• Risk management requirements under TSCA
• EPA's authority and "tools in the toolbox"
• Potential regulatory options
• Additional discussion with Small Entity Representatives
• Closing remarks
U.S. Environmental Protection Agency
-------
Consultation with Small Entity Representatives
• EPA is interested in not only information, but also advice and
recommendations from the small entity representatives (SERs)
• EPA will use this information to inform the agency's decision on potential
regulatory options and to develop a regulatory flexibility analysis, which
becomes part of the record for the potential regulation
U.S. Environmen^l^rotection Agency
3
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Consultation with Small Entity Representatives
• Key elements in this regulatory flexibility analysis:
- Number of small entities to which the potential rule would apply
- Projected compliance requirements of the potential rule
- Identification of all relevant Federal rules which may duplicate, overlap or conflict
with the potential rule
- Any significant alternatives to the potential rule which accomplish the stated
objectives, and which minimize significant economic impact of the potential rule on
small entities
U.S. Environmen^FjYotection Agency 4
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Potentially Affected Entities
• The potential affected industries/sectors for this proposed rule are identified by its NAICS code, SBA
thresholds and U.S. Census Bureau Statistics of U.S. Business datasets, published annually
• 302 industries/sectors and their associated NAICS code have been identified although not all of the
small firms indicated in the attachment are necessarily expected to be impacted by the proposed rule
• SBA size standards vary greatly by NAICS code and range from $8 - $47 million and 100-1,500
employees
• The attachment "Industry Sectors with Small Entities Potentially Affected by the Rulemaking" provides
small firm statistics (number of and employee size) for each industry/sector
• EPA estimates 97% of firms are small entities may be impacted by the proposed rule
• As more specific information about each entity is identified, it is possible that some entities could be
dropped from the list
U.S. Environmen^l^rotection Agency
5
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SERs and the Regulatory Process
• We are seeking information on how the options presented might impact
your business or organization
- Provide specific examples of impacts
- Provide cost data, if available
- Please see detailed questions in a separate handout
U.S. Environmengl^rotection Agency
6
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SERs and the Regulatory Process
• We are also seeking alternative methods of regulating unreasonable risks
identified for NMP
- Suggest other relevant options, including data costs and information on how to ensure
compliance
- Suggest ways that small businesses could benefit from flexibilities, such as different
compliance timetables, simplified reporting requirements, and exemptions
• We would like to minimize duplication
- Provide information on any duplicative or contradictory federal, state, county, or city
regulations you are aware of
- For a list of existing regulations, please see summary of Federal regulations
U.S. Environmen^il^rotection Agency
7
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Key Takeaways from Pre-Panel Outreach Meeting
• Participants: 9 SERs participated and one SER submitted written comments
• SERs discussed: Number and types of small entities affected
- Included how their products are used and identified uses of NMP
- Specifically, SERs described processing incorporation into formulation (in lawn care and
agricultural fertilizer, in pesticides, herbicides, and fungicides, in industrial cleaners), and as an
extraction solvent in re-refining used motor oil. SERs included descriptions of the concentrations
of NMP in the final product in industrial cleaners (1.5% to 15%) and in some pesticide products
(10% by weight or less)
- A processor SER explained that NMP is used as an extraction solvent in order to yield a higher
purity of re-refined oil, and their need NMP for its selectivity for polars and aromatics and low
flammability and volatility
- In written comments, a processor SER described their business as a "cleantech" company
advancing stability, and they described their expected benefits from their technology to re-refine
used motor oil based on reduction in carbon dioxide emissions from used motor oil currently being
disposed of improperly or burned as fuel
U.S. Environm^t^ Protection Agency 8
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Key Takeaways from Pre-Panel Outreach Meeting
• SERs discussed: potential reporting, recordkeeping and compliance
requirements
- SERs discussed their experience with:
• Engineering controls (Enclosed pipes and mixing vessels, vacuum suction pumps, ventilation
systems, carbon scrubbing systems, infrared product formulation verification, fume hoods)
• Personal protective equipment (PRE): Chemically-resistant gloves (standard and elbow-
length), lab coats, glasses/goggles, face shields, boots
• Other exposure controls (e.g., administrative controls and hazard communication): SDS
sheets, good laboratory practices, signs, specialized training
• Substitute chemicals, and their challenges using those substitutes, such as increased
degredation, safety concerns with use (flammable/explosive), less effective than NMP, or
regulatory concerns (are currently subject a TSCA section 5 Significant New Use Rule)
U.S. Environm^t^ Protection Agency
9
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Key Takeaways from Pre-Panel Outreach Meeting
• SERs discussed: potential reporting, recordkeeping and compliance requirements
- SERs discussed their perspective on potential prohibitions:
• In pesticides, herbicides, and fungicides, and industrial cleaners, SERs described how prohibition
on NMP could lead to significant costs for switching to alternatives, especially if pesticide
registrations were needed. SERs described increased costs (material degredation, internal
document revisions, and EPA FIFRA registration delays) associated with use of alternatives,
especially in the case of modified 1 -butyl-2-pyrrolidone or dimethyl sulfoxide
• In solvent extraction operations, a SER described their perspective that alternatives are not as
efficacious as NMP and how identifying those alternatives would lead to significant time delays for
research and development
• In the written comment the processor SER stated that as an extraction solvent NMP could
potentially be replaced by furfural or phenol (hydroxy benzene) but the SER describes these
chemicals as less effective than NMP at extracting polar and aromatic compounds, as well as how,
compared to those chemicals, NMP has a lower flammability, lower volatility, and greater thermal
stability
• SERs also discussed the challenges of identifying feasible alternatives and concern that they had
transitioned back to NMP after using known alternatives
U.S. Environm^t^ Protection Agency
10
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Key Takeaways from Pre-Panel Outreach Meeting
• SERs discussed: Related Federal rules
- Two SERs mentioned FIFRA registration requirements for NMP as an inert in pesticide
formulations. The SERs indicated that if NMP were prohibited there would be cost and
testing requirements associated with registration of a new formulation
- In written comments, while the processor SER did not mention related Federal rules, the
SER indicated they expect health and safety practices to be enforced as part of typical
health and safety protocols at refineries
U.S. Environm^t^ Protection Agency
11
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Key Takeaways from Pre-Panel Outreach Meeting
• SERs discussed: Regulatory flexibility alternatives
- A SER that formulates herbicides, fungicides, and pesticides preferred PPE
requirements; the SER described how PPE changes would be less burdensome for their
business, because engineering control requirements would incur capital costs
- In contrast, a SER who plans to use NMP as an extraction solvent in re-refining used
motor oil stated that administrative or engineering controls would be possible and
preferable. This SER expressed a strong preference for exposure controls that would
prevent a need for prohibition or reductions in concentration.
• In written comments, a processor SER stated that an inability to use NMP would
severely impair their planned business, since NMP is central to unique patented
process they have been developing for 15 years at a cost of over $50 million dollars
U.S. Environm^t^ Protection Agency
12
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Key Takeaways from Pre-Panel Outreach Meeting
SERs described considerations for timeframes for implementation of regulatory
restrictions:
• One SER that processes NMP into industrial cleaners stated that they expected
six to eight months to transition to a known substitute chemical due to
compliance with additional requirements for that chemical (it is subject to a
Significant New Use Rule under TSCA Section 5)
• One SER that processes NMP into pesticides stated that additional testing could
require one to two years; a different SER that processes NMP estimated that at
least two to three years plus additional time for pesticide registration updates
would be needed
• One SER who plans to use NMP as an extraction solvent in re-refining used
motor oil stated that in the event of a prohibition on NMP for this use, they
expected that 10 to 15 years of testing and investment would be needed to
identify an alternative U.S. Environm^jt^ Protection Agency 13
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Overview of the Risk Evaluation for NMP
• Risk evaluation published December 30, 2020:
- 37 conditions of use were evaluated
- Risk evaluation follows a series of opportunities for public input into EPA's NMP risk
evaluation activities
- NMP draft risk evaluation: December 2019; NMP problem formulation: June 2018;
NMP scope document: June 2017
U.S. Environmen^l^rotection Agency
14
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Overview of the Risk Evaluation for NMP
• Public comments arid external scientific peer review informed the final risk
evaluation
- 35 public comments received on the draft risk evaluation (comment period closed
January 21, 2020)
- Peer review: EPA's Science Advisory Committee on Chemicals (SACC) met to review
the draft evaluation (December 2019)
• The risk evaluation and supplemental materials are in docket
, with additional materials supporting the risk evaluation process in
docket EPA-HQ-QPPT-2016-0743. on www.reaulations.gov
U.S. Environmental Protection Agency
15
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Determination of Unreasonable Risk
• In the December 2020 risk evaluation, EPA determined that NMP presented unreasonable
risk to health and the environment. In that risk evaluation, EPA determined that 26 of the 37
conditions of use (COU) of NMP presented unreasonable risk
• With EPA's policy change to a whole chemical approach, EPA has issued a revised whole
chemical unreasonable risk determination without presuming use of PPE. The changes from
that revised determination are included in this presentation and available at
https://www.epa.qov/assessinq-and-manaqinq-chemicals-under-tsca/final-risk-evaluation-n-
methvlpyrrolidone-nmp
• There may be some conditions of use that EPA has determined do not drive the
unreasonable risk but may still be subject to regulation due to uses elsewhere in the supply
chain that drive the unreasonable risk
U.S. Environmentel^rotection Agency
16
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Recent Changes to the Risk Determination
EPA released for public comment a draft revision to the unreasonable risk determination for NMP on
July 1, 2022
EPA published the final revised risk determination on December 19, 2022
Incorporates policy changes announced in June 2021
Specifically, EPA has determined that:
- Making an unreasonable risk determination for NMP as a whole chemical substance, rather than unreasonable
risk determinations separately on each individual condition of use in the risk evaluation, is the most appropriate
approach to NMP under the statute and implementing regulations
- The risk determination does not rely on assumptions regarding the use of personal protective equipment (PPE)
in making the unreasonable risk determination under TSCA section 6, even though some facilities might be
using PPE as one means to reduce workers' exposures; rather, the use of PPE would be considered during risk
management as appropriate
U.S. Environmental Protection Agency
A2-24
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Recent Changes to the Risk Determination
Removing the assumption that workers always and appropriately wear PRE in making the whole
chemical risk determination for NMP result in:
- Three additional conditions of use that drive the unreasonable risk determination for NMP:
• Industrial and commercial use in ink, toner, and colorant products;
• Industrial and commercial use in other uses soldering materials;
• Industrial and commercial use in other uses in fertilizer and other agricultural chemical
manufacturing—processing aids and solvents
U.S. EnvironmentelJ?rotection Agency
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Recent Changes to the Risk Determination Cont
• Additionally, removing the assumption that workers always and appropriately wear PPE in
making the whole chemical risk determination for NMP result in risks for acute non-cancer
effects from inhalation and dermal exposures also driving the unreasonable risk in five
conditions of use (where previously those conditions of use were identified as presenting
unreasonable risk from chronic non-cancer effects):
- Processing for incorporation into articles in paint additives and coating additives not described by other codes in
transportation equipment manufacturing;
- Industrial and commercial use in paints, coatings, and adhesive removers;
- Industrial and commercial use in paints and coatings in lacquers, stains, varnishes, primers, and floor finishes,
powder coatings (surface preparation);
- Industrial and commercial use paint additives and coating additives in multiple manufacturing sectors; and
- Industrial and commercial use in adhesives and sealants including binding agents, single component glues and
adhesives, including lubricant additives, two-component glues, and adhesives including some resins.
U.S. EnvironmentelJJrotection Agency
19
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Recent Changes to the Risk Determination Cont.
• Overall, 29 conditions of use out of 37 EPA evaluated drive the NMP whole chemical
unreasonable risk determination
• EPA has not conducted new scientific analysis on NMP; the risk evaluation continues to
characterize risks associated with individual conditions of use
• The final risk determination is in docket at regulations.gov
U.S. Environmen^l^rotection Agency
20
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Recent Changes to the Risk Determination
Separately, EPA is conducting a screening approach to assess potential risks from the air and water
pathways for several of the first 10 chemicals, including NMP
- This screening analysis was presented to the SACC in March and EPA is currently incorporating comments from
the SACC and public commenters on revisions to the analysis
Exposure pathways that were or could be regulated under another EPA-administered statute were
excluded from the 2020 NMP risk evaluation, resulting in certain air and water pathways not being fully
assessed
EPA's screening approach will identify if there are risks that were unaccounted for in the risk evaluation
for NMP
If the results suggest there is additional risk, EPA will determine if the risk management approach being
contemplated for NMP will protect against these risks or if the risk evaluation will need to be formally
supplemented or revised
U.S. EnvironmentelJ^rotection Agency
21
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NMP Manufacturing and Processing Uses that Drive the
Unreasonable Risk
Manufacturing (domestic manufacturing)
Manufacturing (import)
Processing: As a reactant/intermediate in plastic material and resin manufacturing and other non-
incorporative processing
Processing: Incorporation into formulation, mixture or reaction product in multiple industrial sectors
Processing: Incorporation into articles in lubricants and lubricant additives in machinery manufacturing
Processing: Incorporation into articles in paint additives and coating additives not described by other codes in
transportation equipment manufacturing
Processing: Incorporation into articles as a solvent (which becomes part of a product formulation or mixture)
including in textiles, apparel and leather manufacturing
Processing: Incorporation into articles in other sectors, including in plastic product manufacturing
Processing: Repackaging in wholesale and retail trade
Processing: Recycling
U.S. Environm^t|^ Protection Agency
22
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NMP Industrial and Commercial Uses that Drive the Unreasonable
Risk
Industrial and commercial use in paints, coatings and adhesive removers
Industrial and commercial use in paints and coatings in lacquers, stains, varnishes, primers and floor finishes and
powder coatings in surface preparation
Industrial and commercial use in paint additives and coating additives not described by other codes in computer and
electronic product manufacturing in electronic parts manufacturing
Industrial and commercial use in paint additives and coating additives not described by other codes in computer and
electronic product manufacturing for use in semiconductor manufacturing
Industrial and commercial use in in paint additives and coating additives not described by other codes in multiple
manufacturing sectors
Industrial and commercial use as a solvent (for cleaning or degreasing) in electrical equipment, appliance and
component manufacturing
U.S. Environm^t^ Protection Agency
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NMP Industrial and Commercial Uses that Drive the Unreasonable Risk
Industrial and commercial use as a solvent (for cleaning or degreasing) in electrical equipment, appliance and
component manufacturing for use in semiconductor manufacturing
Industrial and commercial use in ink, toner and colorant products in printer ink and inks in writing equipment
Industrial and commercial use in processing aids, specific to petroleum production in petrochemical
manufacturing, in other uses in oil and gas drilling, extraction and support activities, and in functional fluids
(closed systems)
Industrial and commercial use in adhesives and sealants including binding agents, single component glues
and adhesives, including lubricant adhesives, and two-component glues and adhesives including some resins
Industrial and commercial use in other uses in soldering materials
U.S. Environm^t|j Protection Agency
24
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NMP Industrial and Commercial Uses and Disposal that Drive the
Unreasonable Risk
Industrial and commercial use in other uses in anti-freeze and de-icing products, automotive care products, and
lubricants and greases
Industrial and commercial use in other uses in metal products not covered elsewhere, and lubricant and lubricant
additives including hydrophilic coatings
Industrial and commercial use in other uses in laboratory chemicals
Industrial and commercial uses in other uses in lithium-ion battery manufacturing
Industrial and commercial use in other uses in cleaning and furniture care products, including wood cleaners and
gasket removers
Industrial and commercial use in other uses in fertilizer and other agricultural chemical manufacturing, processing
aids and solvents
Disposal
U.S. Environm^^ Protection Agency
25
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NMP Consumer Uses that Drive the Unreasonable Risk
Consumer use in adhesives and sealants in glues and adhesives, including lubricant adhesives and sealants
U.S. Environmen^l^rotection Agency 26
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Basis for Unreasonable Risk Determination: Workers
• The unreasonable risk determination for workers is based on the following health hazards
during occupational exposures to NMP:
- Developmental effects from acute inhalation and dermal exposures
- Reproductive effects from chronic inhalation and dermal exposures
• Consideration of Personal Protective Equipment (PPE):
- EPA does not assume that workers are always provided or appropriately wear PPE, for the purposes of unreasonable
risk determination
- EPA does not assume that it is a standard industry practice that workers in some small commercial facilities (e.g., those
performing cleaning or degreasing, using automotive care products, soldering materials, or commercial printing and
copying) have a respiratory protection program or regularly employ dermal protection; therefore, the use of respirators
and gloves is assumed to be unlikely for workers in these facilities
- When no PPE is assumed to be in place, 29 of the 37 COUs drive the unreasonable risk
- As previously noted, this assumption results in three additional COUs driving the unreasonable risk determination, and
five conditions of use with acute effects in addition to chronic affects driving the unreasonable risk determination
U.S. Environmen^y^rotection Agency
27
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Basis for Unreasonable Risk Determination: Consumers
The unreasonable risk determinations for consumers is based on the following health
hazards during consumer exposures to NMP:
- Developmental toxicity from acute inhalation and dermal exposure
The unreasonable risk determinations were based on the high intensity risk estimates for
consumers
EPA did not evaluate chronic exposures to NMP for consumer users because EPA
considered the frequency of consumer product use to be too low to create chronic risk
concerns
U.S. Environmen^l^rotection Agency
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Related Regulations and TSCA Section 6 Authority
• NMP is subject to several federal laws and regulations in the United States and is also subject
to regulatory actions by states
- See separate document "Related Regulations (EPA, other Federal, State, and International)" for more information
on the regulatory history of NMP
• EPA determined that NMP presents an unreasonable risk to workers and consumers in the
TSCA risk evaluation
• Therefore, EPA is required to develop risk management actions under TSCA to address the
unreasonable risk
• TSCA Section 9 allows EPA to use statutory authorities to a sufficient extent by action taken
under a Federal law not administrated by the Administrator to reduce or eliminate identified risk
to health or the environment
U.S. Environm^t^ Protection Agency
29
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Risk Management Requirements
• Under TSCA, EPA is required to take action, to the extent necessary, to address chemicals
that pose unreasonable risks to human health or the environment
• EPA must issue a TSCA section 6(a) rule following risk evaluation to address all identified
unreasonable risks within two years:
- Proposed rule one year after risk evaluation
- Final rule two years after risk evaluation
• Specific requirements on consideration of alternatives, selecting among options and
statement of effects apply to risk management rules
• Input from stakeholders is critical to the process and EPA is seeking stakeholder input now
during the SBAR process and during the public comment period following the proposed rule
U.S. Environmen^l^rotection Agency
30
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TSCA 6a Rule Requirements (15 U.S.C 2605(c)(2)):
(A) Statement of effects
- In proposing and promulgating a rule under subsection (a) with respect to a chemical substance or mixture, the Administrator shall consider and
publish a statement based on reasonably available information with respect to—
- (i) the effects of the chemical substance or mixture on health and the magnitude of the exposure of human beings to the chemical substance or
mixture;
- (ii) the effects of the chemical substance or mixture on the environment and the magnitude of the exposure of the environment to such substance
or mixture;
- (iii) the benefits of the chemical substance or mixture for various uses; and
- (iv) the reasonably ascertainable economic consequences of the rule, including consideration of—
• (I) the likely effect of the rule on the national economy, small business, technological innovation, the environment, and public health;
• (II) the costs and benefits of the proposed and final regulatory action and of the 1 or more primary alternative regulatory actions considered
by the Administrator; and
• (III) the cost effectiveness of the proposed regulatory action and of the 1 or more primary alternative regulatory actions considered by the
Administrator.
(B) Selecting requirements
- In selecting among prohibitions and other restrictions, the Administrator shall factor in, to the extent practicable, the considerations under
subparagraph (A) in accordance with subsection (a).
A2-38
31
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TSCA Section 6(a)
TSCA provides EPA with authority to address unreasonable risks, and to regulate entities
including:
- Manufacturers (including importers and importers of articles)
- Processors (e.g., formulators)
- Distributors
- Commercial users (workplaces and workers)
- Entities disposing of chemicals for commercial purposes
Cannot directly regulate consumer users
- Under TSCA, EPA has authority to regulate at the manufacturing, processing and distribution
levels in the supply chain to eliminate or restrict the availability of chemicals and chemical-
containing products for consumer use
- These authorities allow EPA to regulate at key points in the supply chain to effectively address
unreasonable risks to consumers
U.S. Environmen^l^rotection Agency 32
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TSCA Section 6(a) Regulatory Options
• Prohibit, limit or otherwise restrict manufacture, processing or distribution in commerce
• Prohibit, limit or otherwise restrict manufacture, processing or distribution in commerce for
particular use or for use above a set concentration
• Require minimum warnings and instructions with respect to use, distribution, and/or disposal
• Require recordkeeping, monitoring or testing
• Prohibit or regulate manner or method of commercial use
• Prohibit or regulate manner or method of disposal by certain persons
• Direct manufacturers/processors to give notice of the unreasonable risk determination to
distributors, users, and the public and replace or repurchase
U.S. Environmen^lj^rotection Agency 33
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Availability of Alternatives: TSCA Section 6(c)(2)(C)
• TSCA section 6(c)(2)(C) requires EPA.. 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...to the extent practicable, whether technically and economically
feasible alternatives that benefit health or the environment, compared to the
use so proposed to be prohibited or restricted, will be reasonably available as a
substitute when the proposed prohibition or other restriction takes effect"
- Substitute products and methods vary by condition of use
- For example, alternatives to NMP in paint and coating removal include solvent-based alternatives like
n-ethylpyrrolidone (NEP), benzyl alcohol, and other methyl acetate-based stripping formulations, or
process-based alternatives like heat and sanding (
content/uploads/sites/31/2019/09/Final-IMMP-Paint-Stripper-Graffiti-Remover Profile.pdf)
U.S. Environm^t|j Protection Agency 34
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Effective Dates: TSCA Section 6(d)
• TSCA section 6(d) describes effective dates and compliance dates for TSCA section 6(a) rules
• In these rules, EPA must specify an effective date, which must be as soon as practicable
• Except for uses exempted under TSCA section 6(g), EPA must:
- Specify mandatory compliance dates for all rule requirements, no later than five years after
promulgation of the rule, or, in the case of a ban or phase-out:
• Specify mandatory compliance dates for the start of a ban or phase-out requirements, which shall be as
soon as practicable and no later than five years after promulgation of the rule, and
• Specify mandatory compliance dates for full implementation of a ban or phase-out requirements, which
shall be as soon as practicable
• EPA must also provide for a reasonable transition period
U.S. Environmen^lj^rotection Agency
35
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Critical or Essential Uses: TSCA Section 6(g)
TSCA Section 6(g) allows EPA to grant, by rule, a time-limited exemption from a section 6(a) rule for a specific condition of use
• EPA can provide an exemption under three conditions:
— The specific condition of use is a critical or essential use for which no technically and economically feasible safer alternative is available;
— Compliance with the rule would significantly disrupt the national economy, national security, or critical infrastructure; or
— The specific condition of use, as compared to alternatives, provides a substantial benefit to health, the environment, or public safety
In granting an exemption, EPA must:
— Provide a time limit for the exemption
— Analyze the need for the exemption and make the analysis public
— Include conditions, such as recordkeeping, monitoring, and reporting requirements, to the extent EPA determines they are necessary to protect health and the
environment while achieving the purposes of the exemption
EPA appreciates any information to inform whether it would be appropriate to propose an exemption under section 6(g), such as:
— How the exemption request for a COU would meet one or more of the criteria under section 6(g) and information on specific impacts if the chemical were not available
— Whether the chemical is used to meet requirements or specifications from other regulations, describe the process, timeline, and challenges for obtaining
industry/government approval for use of an alternative substance or method
— Description of how long a potential section 6(g) exemption would be needed and why
U.S. Environmental Protection Agency
36
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Hierarchy of Controls
EPA is considering the NIOSH/OSHA
hierarchy of controls when developing risk
management actions
- As described by NIOSH
(https://www.cdc.gov/niosh/topics/hierarchv/default.html),
the hierarchy of controls can be used to implement
feasible and effective controls to protect workers
- It typically includes elimination, substitution, engineering
controls, administrative controls, and PRE on a scale of
most to least protective
Any regulatory requirement can be used alone or
in combination to the extent necessary so that
NMP no longer presents an unreasonable risk
under its conditions of use
Most
effective
Hierarchy of Controls
¦
Least
effective
Elimination
Substitution
Engineering
Controls
Administrative
Controls
PPE f—
f
¥
Physically remove
the hazard
Replace
the hazard
Isolate people
from the hazard
Change the way
people work
Protect the worker with
Personal Protective Equipment
image by NIOSH
b ttps-J/www. cdc gov/niosh/topics/h ierarchy/defa u It. h tm I
U.S. Environm^t||Protection Agency
37
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Potential Regulatory Options
EPA has considered several regulatory options under TSCA section 6(a), and a wide range of risk
reduction practices and options
Through Agency review and stakeholder input, the following potential options have been identified
as reducing exposures, so NMP no longer presents an unreasonable risk of injury to health
These options are currently being considered and evaluated by EPA, and are not final at this time.
EPA has not made a decision at this point about what regulatory options to propose
Regulatory requirements could be used alone or in combination to the extent necessary so that
NMP no longer presents an unreasonable risk under its conditions of use
- Additionally, under TSCA section 6(g), EPA may propose a time-limited exemption for a specific condition
of use under three circumstances, as discussed previously on slide 30
U.S. Environm^t^ Protection Agency
38
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Potential Regulatory Options
Prohibit use above a set concentration (concentration limits)
Prescriptive PPE controls
Prescriptive administrative controls
Prescriptive engineering controls
Combination of controls (non-prescriptive)
Prohibit or restrict manufacturing, processing, and distribution
Prohibit or restrict manufacturing, processing, and distribution for a particular
Regulatory options applied broadly with other restrictions
- Recordkeeping and downstream notification
- Monitoring and labeling
- Training, certification, and limited access program
U.S. Environmen^l^rotection Agency
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Potential Regulatory Options, cont.
• EPA has not decided on the primary regulatory options to propose in the rule.
• Nonetheless, EPA's primary performance metric for eliminating the unreasonable risk
of injury to human health is to eliminate or reduce significantly direct dermal contact
with NMP. EPA is considering the following regulatory options and seeking feedback
on the impacts of applying one or more of the following regulatory options to address
the unreasonable risk from NMP.
• Unlike some of the other chemicals currently undergoing risk management under
TSCA section 6, EPA is not considering an airborne concentration limit for NMP and is
focusing on dermal protection measures. The 2020 risk evaluation for NMP and
revised unreasonable risk determination found that the unreasonable risk of injury to
human health is driven by direct dermal contact with liquid NMP.
U.S. Environmen^lJ^rotection Agency
40
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Potential Regulatory Options, cont.
For processing, industrial, and commercial uses (occupational exposures) EPA is considering the following regulatory
options to address the unreasonable risk:
- Concentration Limit
• A risk management option that would restrict the concentration or weight fraction within the formulation.
• For example, if scientific analysis based on the 2020 Risk Evaluation supported it, EPA could limit the percentage amount
of the chemical in the formulation if that percentage addressed the unreasonable risk and the formulation was still
efficacious.
• In the 2020 Risk Evaluation for NMP, EPA identified the expected weight fraction of NMP in liquid products based on
publicly available information, public comments, and available products on the market (see separate handout: Information
on Weight Fractions of NMP Evaluated in the 2020 Risk Evaluation). If ranges of NMP in formulations were identified, EPA
generally assessed the lower bound of the range as the central tendency and the upper bound of the range as the high
end.
- Example: EPA identified and assessed the commercial use of NMP in paints, coatings, adhesives and sealants based on
products with 2-53% NMP. At the high-end concentration, in the expected occupational exposure scenarios, these conditions
of use drive the unreasonable risk.
- Example: EPA identified and assessed the commercial use of NMP in metal finishing products with 60-90% NMP. At these
concentrations, in the expected occupational exposure scenarios, this condition of use drives the unreasonable risk.
• There is uncertainty if lowering the concentration limit may impact efficacy of the products. For a concentration or weight
fraction limit to address the unreasonable risk, it would need to be lower than those that drove the unreasonable risk in the
risk evaluation.
U.S. Environmen^l^rotection Agency
41
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Potential Regulatory Options, cont.
• Prescriptive Engineering Controls
- Would reduce worker exposure by requiring specific physical changes to the workplace to
eliminate or reduce direct dermal contact
- Examples: installing additional or different equipment, such as enclosed transfer liquid lines,
closed loop container systems or a laboratory type fume hood, to reduce the exposure to the
chemical
• Prescriptive Administrative Controls
- Would reduce worker exposure by requiring processes or procedures in the workplace to eliminate
or reduce direct dermal contact
- Examples: Limit access to work areas (restricted areas) or confining operations (enclosed areas)
- EPA's confidence that the unreasonable risk from NMP can be addressed is highest for highly
standardized and industrialized settings, such as where NMP is used in a closed-loop system
U.S. Environmen^l^rotection Agency
42
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Potential Regulatory Options, cont.
Prescriptive PRE Controls
- A risk management option that would require the use of specific PRE to minimize exposure. This may limit flexibility for
the regulated entity
Some examples of potential PPE that could contribute to reducing the unreasonable risk are listed separately in Appendix F of the 2020 final risk
evaluation, as well as the Potential Costs of Regulatory Options table later in this presentation
- Requiring the use of dermal and inhalation PPE that provides an impervious barrier in combination with a set
concentration limit of NMP would allow more flexibility for regulated entities to mitigate unreasonable risk
- EPA anticipates that PPE would need to be combined with training and other controls in order to address the
unreasonable risk from NMP
Combination of Controls (non-prescriptive)
- A combination of risk management approaches for conditions of use where strict industrial practices may already exist.
Enables users to determine how to most effectively separate, distance, physically remove, or isolate workers from direct
handling of NMP or from contact with equipment/materials for which NMP may exist based on what works best for their
workplace and the ability to combine prescriptive controls
- Would eliminate direct dermal contact in accordance with the Pollution Prevention Act and NIOSH hierarchy of controls
- Could include engineering or administrative controls to reduce or eliminate exposure
- If direct dermal contact could not be eliminated using elimination, substitution, engineering controls, or administrative
controls, could require personal protective equipment that provides an impervious barrier
- Examples: Automation, barriers, or design of tools
U.S. Environmental Protedtion Agency
43
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Potential Regulatory Options, cont.
• Prohibition
- EPA could include prohibition on manufacturing, processing, distribution, use, or disposal for
specific conditions of use or the chemical as a whole
- EPA requests data and feedback about availability and viability of NMP alternatives, testing and
analysis that SERs have completed of potential alternatives, the cost impacts of SERs
switching to alternatives, and the overall impacts to SERs' businesses if NMP is prohibited.
U.S. Environmen^l^rotection Agency
44
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Potential Regulatory Options, cont.
• For consumer uses, EPA is considering the following regulatory options to
address the unreasonable risk:
- Regulation at key points in the supply chain (manufacturing, processing, and/or
distribution) to address unreasonable risks to consumers
• Example: March 2019 rule to address unreasonable risks to consumers from
methylene chloride in paint and coating removal prohibited manufacture (including
import), processing, and distribution in commerce of methylene chloride for this use
(including distribution to and by retailers)
- Potential regulatory options:
• Prohibition
• Concentration Limits
• Container size
U.S. Environmental Protedtjon Agency
-------
Potential Regulatory Options, cont.
• Regulatory options applied broadly with other restrictions
- Recordkeeping - example: ordinary business records to demonstrate compliance
(for example not selling products to consumers)
- Downstream notification - example: modify the SDS to indicate that the product
should not be used in consumer products or indicate other regulatory requirements
- Monitoring - example: monitor for compliance or concentration limits
- Labeling - example: labeling products to indicate that they should not be used by
consumers or to describe other regulatory requirements
- Container size - example: a minimum or maximum container size (e.g., 32 ounce
container, 55 gallon drum) to reduce likelihood of purchase by certain types of users
(consumers or commercial users)
- Limited access program - example: access only to users with certain equipment or
types of facilities
U.S. EnvironmemaJ53rotection Agency
-------
Cost of Regulatory Options
Option/Type of Cost
Prohibition of manufacturing,
processing, and distribution
Prohibition of Use
Reformulation of product
to eliminate NMP
Substitute Products (price per
ounce)
Estimated Compliance Cost
Varies with condition of use
Varies with condition of use
$60,000-$102,000 per product
Varies with condition of use
DMSO:
$0.73/ounce (vol)
Furfural:
$0.70/ounce (vol)
Phenol (hydroxy benzene):
$1.30/ounce (wt)
Notes
Cost will vary by condition of use. Potential activities could
include changes in process and equipment, costs of alternatives,
reformulation (see below), and more. Requires input from
potentially regulated entities.
Cost will vary by condition of use. Potential activities could
include changes in process and equipment, costs of alternatives,
reformulation (see below), and more. Requires input from
potentially regulated entities.
Costs will vary by condition of use and will be dependent on
reformulation approach. Requires input from potentially regulated
entities.
Would vary by price of NMP per ounce vs. substitutes, as well as the
differences in efficacy of the substitute products. This is only a material
cost and excludes changes in equipment, technology, training, testing,
etc. Example prices are from a scientific retailer. Requires input from
potentially regulated entities.
Reformulation of product to $17,000 per product t 47
reduce NMP concentration
U.S. Environmental Protection Agency
Costs reflect dilution reformulation approach. Requires input from
A2-s4Dotentially regulated entities.
-------
Cost of Regulatory Options, cont.
Option/Type of Cost
Engineering/
Administrative Controls
Personal Protective Equipment
(PPE) - (e.g., respirators)
Personal Protective Equipment
(PPE) (dermal)
Estimated Compliance Cost
Notes
user
APF 10:
$1,800
APF 25:
$1,300
APF 50:
$1,700
APF 1000:
$1,100
APF 10000:
$2,000
Varies by control type and needs of Requires input from potentially regulated entities
Annualized costs are per person and include purchase
of equipment (including filters), training, fit-testing, and
medical clearance. The unit costs include a written
respiratory program and equipment cleaning. Does not
include existing PPE use nor PPE replacement due to
employee turn-over. Includes both purified and supplied
air respirators.
Reusable glove costs are per pair of butyl, laminated
polyethylene, neoprene, and natural rubber/latex
gloves. Disposable glove costs are per pair of nitrile
gloves. Disposable nitrile gloves are not used alone, but
in combination with the reusable gloves. Reusable
apron costs are per nitrile and neoprene apron.
Disposable apron costs are per polyethylene apron.
A2-55
U.S. Environmental Protection Agency
Reusable gloves: $6-$55
Disposable gloves: $0.50
Reusable apron:$25-$34
Disposable apron: $4
-------
Cost of Regulatory Options, cont.
Option/Type of Cost
Combination of controls (non-
prescriptive)
Estimated Compliance Cost
Annualized costs of Exposure control
plan:
$560-$630 per facility costs
$35 per worker costs
One-time costs of Exposure control plan:
- 40 hours one time cost to develop plan:
$3,730 per facility
- 4 hours annual cost for regular
inspections: $370 per facility per year
- 0.43 hours annual recordkeeping: $40
per facility per year
Notes
Non-prescriptive approach would likely include
development of an exposure control plan. Costs include
costs for conducting regular inspections, PRE program
plan documentation, records of plan implementation,
and records of dermal exposure. Includes both per-
facility and per-worker costs. Costs will depend on
baseline PRE and dermal exposure control plan
activities.
Costs of engineering controls,
monitoring, or PPE varies by control type
and needs of user
See PPE costs for glove and apron costs
U.S. Environmental Protection Agency
-------
Cost of Regulatory Options, cont.
Option/Type of Cost
Estimated Compliance Cost
Notes
Product Label or Warnings
$830- $8,900 per product, one time cost
Costs will vary by condition of use. Potential
activities may nclude graphic design changes,
plate changes, discarded inventory, and labor.
Container Sizes
$9,500-$47,500 per product, one time cost
A change in container size would lead to costs at
the lower end while a packaging material change
would likely result in costs at the higher end.
Substitute Methods
Varies by job labor rate
This will primarily be labor cost and cost of
alternative equipment.
U.S. Environmen^l^rotection Agency
50
-------
Cost of Regulatory Options, cont.
Option/Type of Cost
Estimated Compliance Cost
Notes
Recordkeeping
$218-$340 per firm
Ongoing annual labor and material costs
associated with documentation of ordinary
business records.
Downstream Notification
$121 -$138 per product, one time cost
Costs are per product and include labor and
material costs to update a product's safety data
sheet (SDS).
Limited Access Program
Varies with condition of use and type of
distributor
Would vary by type of requirements for
certification and any distribution processes or
restrictions already in place.
U.S. EnvironmentelProte©tjon Agency
51
-------
In-Depth Discussion on Conditions of Use for NMP
1. Manufacturing, repackaging/recycling, and disposal
2. Commercial processing and formulation uses
3. Industrial and commercial paint, coating, and solvent uses
4. Industrial and commercial uses in manufacturing of
electronic parts, semiconductors, and lithium-ion batteries
5. Consumer uses
U.S. EnvironmentelProte©tjon Agency
52
-------
NMP Group 1: Manufacturers, Repackaging/Recycling,
and Disposal
Relevant conditions of use:
- Manufacturing (domestic manufacture)
- Manufacturing (import)
- Processing: repackaging in wholesale and retail trade
- Processing: recycling
- Disposal
What is NMP used for? How is it applied?
- NMP is domestically manufactured, imported, and repackaged from bulk containers to smaller containers; NMP is
loaded and unloaded into different containers
- NMP waste streams are collected and transported to third-party sites for disposal, treatment, or recycling
U.S. Environmental Protection Agency
53
-------
Potential Regulatory Options for NMP Group 1:
Manufacturing, Repackaging/Recycling, and Disposal
As noted previously EPA is considering the following regulatory options and is seeking your
feedback. Any regulatory requirement could be used alone or in combination to the extent
necessary so that NMP no longer presents an unreasonable risk under its conditions of use:
• Prescriptive Controls (Engineering, Administrative, PPE)
• Combination of Controls (Non-Prescriptive)
• Prohibition
• Regulatory options applied broadly with other restrictions
- Recordkeeping and downstream notification
- Monitoring and labeling
U.S. Environmental Protection Agency
54
-------
Discussion with Small Entity Representatives
Please provide your comments or questions regarding:
• Number and types of small entities affected
• Potential reporting, recordkeeping and compliance
requirements
• Related Federal rules
• Regulatory flexibility alternatives
U.S. Environmental Protedtjon Agency
-------
Discussion - Your Business and NMP
• How does your organization use NMP?
• Can you describe the specific use, as well as the workplace and workplace
setting where it is used?
• What is the trend of NMP use in your organization?
• How important to your business is the function that NMP provides?
• Are there potential critical or essential uses?
• Are there uses for which there are no available technically or economically
feasible alternatives?
U.S. Environmen^y^rotection Agency 56
-------
Discussion - Workplace Exposure
• What is your experience with exposure control and risk reduction?
• How many employees are exposed to NMP, and for how long (days/years and hours/day)?
• What is the concentration of NMP in the product you use?
• What routine worker activities result in worker exposure to NMP and what type of exposure?
• What engineering controls are used to minimize exposure to NMP? Are additional controls
feasible?
• What administrative controls and training do you use to minimize exposure to NMP?
• What respiratory and dermal PPE is regularly worn by workers to minimize exposure to NMP?
U.S. Environmengl^rotection Agency
57
-------
Discussion - Regulatory Options
• What regulatory approach should EPA take?
• Are there concerns about the ability to comply with any of the
potential regulatory options?
• What advice do you have for reducing impacts on small
businesses?
• What timeframe would your business need to comply with
potential new regulations or restrictions?
U.S. Environmentel^rotection Agency
58
-------
NMP Group 2: Processors
Relevant conditions of use
- Processing - as a reactant or intermediate in plastic material and resin manufacturing and other non-incorporative
processing
- Processing - Incorporation into a formulation, mixture or reaction product in multiple industrial sectors
- Processing - Incorporation into articles in lubricants and lubricant additives in machinery manufacturing
- Processing - Incorporation into articles as a solvent (which becomes part of a product formulation or mixture) including
in textiles, apparel and leather manufacturing
- Processing - Incorporation into articles in paint additives and coating additives not described by other codes in
transportation equipment manufacturing
- Processing - Incorporation into articles in other sectors, including in plastic product manufacturing
What is NMP used for? How is it applied?
- NMP is commonly used as a feedstock in the production of other chemicals products and may be incorporated into
various products and formulations at varying concentrations for further distribution
- These uses entail use of NMP as an intermediate, as a media for synthesis, processing, and purification
- NMP may be used for maintenance, bottling, shipping, sampling and loading into or unloading from containers
U.S. Environmental Protection Agency
59
-------
Potential Regulatory Options for NMP Group 2: Processors
As noted previously EPA is considering the following regulatory options and is seeking your
feedback. Any regulatory requirement could be used alone or in combination to the extent
necessary so that NMP no longer presents an unreasonable risk under its conditions of use :
Concentration Limit
Prescriptive Controls (Engineering, Administrative, PPE)
Combination of Controls (Non-Prescriptive)
Prohibition
Regulatory options applied broadly with other restrictions
- Recordkeeping and downstream notification
- Monitoring and labeling
U.S. Environmen^y^rotection Agency 60
-------
Discussion with Small Entity Representatives
Please provide your comments or questions regarding:
• Number and types of small entities affected
• Potential reporting, recordkeeping and compliance
requirements
• Related Federal rules
• Regulatory flexibility alternatives
U.S. Environmental Protedtjon Agency
-------
Discussion - Your Business and NMP
• How does your organization use NMP?
• Can you describe the specific use, as well as the workplace and workplace
setting where it is used?
• What is the trend of NMP use in your organization?
• How important to your business is the function that NMP provides?
• Are there potential critical or essential uses?
• Are there uses for which there are no available technically or economically
feasible alternatives?
U.S. Environmen^y^rotection Agency 62
-------
Discussion - Workplace Exposure
• What is your experience with exposure control and risk reduction?
• How many employees are exposed to NMP, and for how long (days/years and hours/day)?
• What is the concentration of NMP in the product you use?
• What routine worker activities result in worker exposure to NMP and what type of exposure?
• What engineering controls are used to minimize exposure to NMP? Are additional controls
feasible?
• What administrative controls and training do you use to minimize exposure to NMP?
• What respiratory and dermal PPE is regularly worn by workers to minimize exposure to NMP?
U.S. EnvironmengLf^rotection Agency
63
-------
Discussion - Formulators of Products Containing NMP
• Product reformulation
- How often do you reformulate your products?
- What is the typical cost of reformulating your products?
- What might reformulation costs be if you needed to reformulate your products
without NMP? (For example, costs might include R&D, testing, capital costs of
production changes, packaging, labeling)
• Product relabeling
- How often do you relabel your products?
- What is the typical cost of relabeling?
U.S. Environmen^L^rotection Agency
-------
Discussion - Formulators of Products Containing NMP (Cont.)
• Alternatives
- Do you sell another product that does not contain NMP that is designed for
the same use or application as the NMP product?
• If yes, what solvent replaces NMP in the alternative product? How does the alternative
product compare in terms of safety, efficacy, and cost?
• If no, if you needed to reformulate this product with a lower concentration of NMP, what would
the implications be for the product in terms of cost and efficacy? What solvent would replace
NMP? How do you think the alternative would compare in terms of efficacy and cost?
- Are there any restrictions or other limitations that prescribe the use of NMP
to perform your services (e.g., for aerospace or DOD customers)?
- Is there a subset of uses for your product where using a product formulated
without NMP would be problematic?
U.S. Environmen^|[l^rotection Agency
65
-------
Discussion - Regulatory Options
• What regulatory approach should EPA take?
• Are there concerns about the ability to comply with any of the
potential regulatory options?
• What advice do you have for reducing impacts on small
businesses?
• What timeframe would your business need to comply with
potential new regulations or restrictions?
U.S. Environmen^L^rotection Agency
66
-------
NMP Group 3: Industrial and Commercial Paint and
Coating and Solvent Uses
• Relevant conditions of use:
- Industrial and commercial use in paints, coatings, and adhesive removers
- Industrial and commercial use in paints and coatings in lacquers, stains, primers and floor finishes and powder coatings in surface
preparation
- Industrial and commercial use in paint additives and coating additives not described by other codes in multiple manufacturing
sectors
- Industrial and commercial use in ink, toner and colorant products in printer ink and inks in writing equipment
- Industrial and commercial use in processing aids, specific to petroleum production in petrochemical manufacturing, in other uses in
oil and gas drilling, extraction and support activities, and in functional fluids (closed systems)
- Industrial and commercial use in adhesives and sealants including binding agents, single component glues and adhesives, including
lubricant adhesives, and two-component glues and adhesives including some resins
- Industrial and commercial use in soldering materials
- Industrial and commercial use in anti-freeze and de-icing, automotive care products, and lubricants and greases
- Industrial and commercial use metal products, lubricant and lubricant additives including hydrophilic coatings
- Industrial and commercial use in laboratory chemicals
- Industrial and commercial use in cleaning and furniture care products, including wood cleaners and gasket removers
- Industrial and commercial use in fertilizer and other agricultural chemical manufacturing, processing aids, and solvents
67
U.S. Environmental Prot&taton Agency
-------
NMP Group 3: Industrial and Commercial Paint and
Coating and Solvent Uses
• What is NMP used for? How is it applied?
- NMP is used in paints and coatings, in paint/coating additives and as a solvent for cleaning and
degreasing to remove a variety of contaminants and materials in a variety of businesses
- NMP is used in processing aids in petroleum production in petrochemical manufacturing, in other
uses in oil and gas drilling, extraction and support activities and in functional fluids in a closed
system
- NMP is also used in adhesives and sealants and in various automotive care products including anti-
freeze, de-icing products and lubricants and greases
- NMP is also used in metal products
- Activities include loading/unloading, analytical and maintenance activities
U.S. Environmental Pro||(^on Agency
68
-------
Potential Regulatory Options for NMP Group 3: Industrial
and Commercial Paint and Coating and Solvent Uses
As noted previously EPA is considering the following regulatory options and is seeking your feedback.
Any regulatory requirement could be used alone orTn combination to the extent necessary so that NMP
no longer presents an unreasonable risk under its conditions of use:
• Concentration Limit
• Prescriptive Controls (Engineering, Administrative, PPE)
• Combination of Controls (Non-Prescriptive)
• Prohibition
• Regulatory options applied broadly with other restrictions
- Recordkeeping and downstream notification
- Monitoring and labeling
- Container size
U.S. Environmen^L^rotection Agency
69
-------
Discussion with Small Entity Representatives
Please provide your comments or questions regarding:
• Number and types of small entities affected
• Potential reporting, recordkeeping and compliance
requirements
• Related Federal rules
• Regulatory flexibility alternatives
U.S. Environmen^Lf^rotection Agency
-------
Discussion - Your Business and NMP
• How does your organization use NMP?
• Can you describe the specific use, as well as the workplace and workplace
setting where it is used?
• What is the trend of NMP use in your organization?
• How important to your business is the function that NMP provides?
• Are there potential critical or essential uses?
• Are there uses for which there are no available technically or economically
feasible alternatives?
U.S. Environmen^LJ^rotection Agency 71
-------
Discussion - Workplace Exposure
• What is your experience with exposure control and risk reduction?
• How many employees are exposed to NMP, and for how long (days/years and hours/day)?
• What is the concentration of NMP in the product you use?
• What routine worker activities result in worker exposure to NMP and what type of exposure?
• What engineering controls are used to minimize exposure to NMP? Are additional controls
feasible?
• What administrative controls and training do you use to minimize exposure to NMP?
• What respiratory and dermal PPE is regularly worn by workers to minimize exposure to NMP?
U.S. Environmen^Lf^rotection Agency 72
-------
Discussion - Users of Products Containing NMP
• What chemicals or processes have you considered as an alternative to using
NMP or a product containing NMP?
• Do you currently use any alternatives to NMP or products containing NMP?
• Did you try to switch to another chemical, process, or product, only to switch
back? If so, what did you switch to, why did you switch back, and what made you
switch in the first place?
• Are there any restrictions or other limitations that prescribe the use of NMP to
perform your services (e.g., for aerospace or DOD customers)?
• What are the relative advantages and disadvantages of different substitutes
and/or processes that you have considered, including in terms of exposure, cost,
and hazard?
U.S. Envirormmi-e® Protection Agency
73
-------
Discussion - Regulatory Options
• What regulatory approach should EPA take?
• Are there concerns about the ability to comply with any of the
potential regulatory options?
• What advice do you have for reducing impacts on small
businesses?
• What timeframe would your business need to comply with
potential new regulations or restrictions?
U.S. Environmen^l^rotection Agency
74
-------
NMP Group 4: Industrial and Commercial Uses in
Manufacturing of Electronic Parts, Semiconductors, and
Lithium-Ion Batteries
• Relevant conditions of use:
• Industrial and commercial use in paint additives and coating additives not described by other codes in computer
and electronic product manufacturing in electronic parts manufacturing
• Industrial and commercial use in paint additives and coating additives not described by other codes in computer
and electronic product manufacturing for use in semiconductor manufacturing
• Industrial and commercial use as a solvent (for cleaning or degreasing) in electrical equipment, appliance
and component manufacturing
• Industrial and commercial use as a solvent (for cleaning or degreasing) in electrical equipment, appliance
and component manufacturing for use in semiconductor manufacturing
• Industrial and commercial uses in other uses in lithium-ion battery manufacturing
• What is NMP used for? How is it applied?
- NMP is used as a paint additive and coating additive and as a solvent in cleaning and degreasing in manufacturing of
electronic parts and semiconductors
- NMP is used in lithium-ion battery manufacturing in cathode coating, cathode mixing, and other activities
U.S. Environmen^y^rotection Agency 75
-------
Potential Regulatory Options for NMP Group 4: Industrial
and Commercial Uses in Manufacturing of Electronic Parts,
Semiconductors, and Lithium-Ion Batteries
As noted previously EPA is considering the following regulatory options and is seeking your
feedback. Any regulatory requirement could be used alone or in combination to the extent
necessary so that NMP no longer presents an unreasonable risk under its conditions of use :
• Prescriptive Controls (Engineering, Administrative, PPE)
• Combination of Controls (Non-Prescriptive)
• Prohibition
• Regulatory options applied broadly with other restrictions
- Recordkeeping and downstream notification
- Monitoring and labeling
U.S. Environmen^y^rotection Agency 76
-------
Discussion with Small Entity Representatives
Please provide your comments or questions regarding:
• Number and types of small entities affected
• Potential reporting, recordkeeping and compliance
requirements
• Related Federal rules
• Regulatory flexibility alternatives
U.S. Environmen^l^rotection Agency
-------
Discussion - Your Business and NMP
• How does your organization use NMP?
• Can you describe the specific use, as well as the workplace and workplace
setting where it is used?
• What is the trend of NMP use in your organization?
• How important to your business is the function that NMP provides?
• Are there potential critical or essential uses?
• Are there uses for which there are no available technically or economically
feasible alternatives?
U.S. Environmen^l^rotection Agency 78
-------
Discussion - Workplace Exposure
• What is your experience with exposure control and risk reduction?
• How many employees are exposed to NMP, and for how long (days/years and hours/day)?
• What is the concentration of NMP in the product you use?
• What routine worker activities result in worker exposure to NMP and what type of exposure?
• What engineering controls are used to minimize exposure to NMP? Are additional controls
feasible?
• What administrative controls and training do you use to minimize exposure to NMP?
• What respiratory and dermal PPE is regularly worn by workers to minimize exposure to NMP?
U.S. Environmentel^rotection Agency
79
-------
Discussion - Users of Products Containing NMP
• What chemicals or processes have you considered as an alternative to using
NMP or a product containing NMP?
• Do you currently use any alternatives to NMP or products containing NMP?
• Did you try to switch to another chemical, process, or product, only to switch
back? If so, what did you switch to, why did you switch back, and what made you
switch in the first place?
• Are there any restrictions or other limitations that prescribe the use of NMP to
perform your services (e.g., for aerospace or DOD customers)?
• What are the relative advantages and disadvantages of different substitutes
and/or processes that you have considered, including in terms of exposure, cost,
and hazard?
U.S. Environmsafefl Protection Agency
80
-------
Discussion - Regulatory Options
• What regulatory approach should EPA take?
• Are there concerns about the ability to comply with any of the
potential regulatory options?
• What advice do you have for reducing impacts on small
businesses?
• What timeframe would your business need to comply with
potential new regulations or restrictions?
U.S. Environmentel^rotection Agency
81
-------
NMP Group 5: Consumer Uses
• Relevant condition of use:
- Consumer use in adhesives and sealants in glues and adhesives, including
lubricant adhesives and sealants
U.S. Environmental Protection Agency
-------
Potential Regulatory Options for NMP Group 5: Consumer
Uses
As noted previously EPA is considering the following regulatory options and is seeking your
feedback. Any regulatory requirement could be used alone or in combination to the extent
necessary so that NMP no longer presents an unreasonable risk under its conditions of use :
• Prohibition of manufacturing, processing or distribution of products for consumer use
• Concentration limit
• Regulatory options applied broadly with other restrictions
- Recordkeeping and downstream notification
- Monitoring and labeling
- Container size
U.S. EnvironmenglgS^rotection Agency
83
-------
Discussion with Small Entity Representatives
Please provide your comments or questions regarding:
• Number and types of small entities affected
• Potential reporting, recordkeeping and compliance
requirements
• Related Federal rules
• Regulatory flexibility alternatives
U.S. Environmen^l^rotection Agency
-------
Discussion - Your Business and NMP
• How does your organization use NMP?
• Can you describe the specific use, as well as the workplace and workplace
setting where it is used?
• What is the trend of NMP use in your organization?
• How important to your business is the function that NMP provides?
• Are there potential critical or essential uses?
• Are there uses for which there are no available technically or economically
feasible alternatives?
U.S. Environmen^lJ^rotection Agency 85
-------
Discussion - Distributors and Retailers
• What is your experience with exposure control and risk reduction?
• If you could no longer sell products containing NMP, how would this impact your
business?
• Are there particular challenges to small business doing distribution of products
containing NMP that are different from large distributors?
• What is your preferred method of downstream notification?
• If you were required to limit sales of NMP containing products to only persons
who were certified to purchase it, what activities and costs would be involved?
What guidance would be helpful from the Agency?
U.S. Environmen^lJ^rotection Agency 86
-------
Discussion - Regulatory Options
• What regulatory approach should EPA take?
• Are there concerns about the ability to comply with any of the
potential regulatory options?
• What advice do you have for reducing impacts on small
businesses?
• What timeframe would your business need to comply with
potential new regulations or restrictions?
U.S. Environmen^|[lg[^rotection Agency
87
-------
Closing Session
• Closing remarks from EPA, SBA, and OMB
• Next steps
- Written comments by June 7, 2023
- The risk evaluation and supplemental materials are in docket EPA-
HQ-OPPT-2019-0236, with additional materials supporting the risk
evaluation process and the revised unreasonable risk determination
in docket EPA-HQ-OPPT-2016-0743, on www.reaulations.gov
U.S. Environmen^|[lg!^rotection Agency
-------
Additional Information
• General TSCA: https://www.epa.aov/assessina-and-manaaina-chemicals-under-tsca/frank-r-
lautenbera-chemical-safetv-21st-centurv-act
• Current Chemical Risk Management Activities: https://www.epa.gov/assessina-and-manaaing-
¦ -J. •:.; =.-5c -;: ^ y„ -\
chemicals-under-tsca/current-chemical-risk-management-activities
• NMP Risk Management: https://www.epa.gov/assessing-and-managing-chemicals-under-
tsca/risk-management-n-methvlpvrrolidone-nmp
• June 2021 Policy Changes: https://www.epa.gov/newsreleases/epa-announces-path-forward-
tsca-chemical-risk-evaluations
• NMP: Clara Hull (Hull.Clara@epa.gov. 202-564-3954)
U.S. EnvironmenglgS^rotection Agency
89
-------
Contact Information
• EPA SBAR contact: Lanelle Wiggins (Wiqqins.Lanelle@epa.gov)
• EPA NMP: Clara Hull (Hull.0 ara@epa.gov)
• SBA Advocacy: Tabby Zeb ( "avvaba.Zeb@sba.gov)
• OMB OIRA: Mike Ciccarone (Michael.i.Ciccarone2@omb.eop.gov)
U.S. Environmen^lJ^rotection Agency
-------
Appendix
• Panel Outreach SER Questions for Discussion (separate document)
• Related Regulations (EPA, other Federal, state, and international)
(separate document)
• Industry Sectors with Small Entities Potentially Affected by the
Rulemaking (separate document)
• Personal Protective Equipment Respirator System Per Worker Unit Cost
Breakdown (separate document)
• NMP Weight Fraction Table (separate document)
• Pesticide Inert Ingredients Interpretation (separate document)
• Example: OSHA Respiratory Protection Table (Slide 92)
• Dermal Personal Protective Equipment Unit Cost (Slide 93)
U.S. Environmen^lgFjJrotection Agency 91
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Dermal Personal Protective Equipment Unit Cost
Glove Material
Butyl
Natural Rubber/Latex
Neoprene
Laminated Polyethylene
Nitrile
Apron Material
Polyethylene
Neoprene
Nitrile
Type
Reusable
Reusable
Reusable
Reusable
Disposable
Average Price Per Useful Life (pairs
Pair (2021$)
$54.53
$6.16
$11.25
$7.48
$0.56
per year)
4
4
4
4
260
Type
Disposable
Reusable
Reusable
Average Price per Useful Life (per
Apron (2021$) year)
$3.64 260
$33.87 4
$25.13 4
U.S. Environmental Protection Agency
93
-------
Industry Sectors with Small Entities Potentially Affected by the
Rulemaking (updated from Pre-Panel version)
A2-101
-------
EPA's SBAR Panel Outreach Meeting with Small Entity Representatives on Proposed
Rulemaking for n-Methylpyrrolidone (NMP) under TSCA Section 6(a)
Industry Sectors with Small Entities Potentially Affected by the Rulemaking
Entities potentially regulated by this rulemaking to address the unreasonable risks from NMP include
those entities relevant to the conditions of use of NMP that EPA evaluated, including domestic
manufacturing, import, processing uses of NMP, repackaging and recycling, industrial and commercial
uses of NMP (such as solvents for cleaning or degreasing, adhesives and sealants, lubricants and greases,
paints and coatings, and in a variety of cleaning products), consumer uses (including adhesives and
sealants), and disposal. Entities may include manufacturers (including importers), processors,
formulators, industrial and commercial users, or distributors (such as retailers) of NMP or products
containing NMP within the scope of this rulemaking.
Potentially affected entities will include both employer and non-employer firms and establishments
identified within these sectors by the U.S. Census for each applicable North American Industry
Classification System (NAICS) code. Since the Small Business Administration (SBA) size standard varies by
NAICS code, they are also included in the table below. NAICS codes of potentially affected entities may
include but are not limited to those in Table 1 below. Table 2 shows the estimated number of small firms
by condition of use (COU).
Table 1: Potentially Affected Entities
NAICS
NAICS Description
SBA Size Standard
111110
Soybean Farming
$2.3 million
111120
Oilseed (except Soybean) Farming
$2.3 million
111130
Dry Pea and Bean Farming
$2.8 million
111140
Wheat Farming
$2.3 million
111150
Corn Farming
$2.5 million
111160
Rice Farming
$2.5 million
111191
Oilseed and Grain Combination Farming
$2.3 million
111199
All Other Grain Farming
$2.3 million
111211
Potato Farming
$4.3 million
111219
Other Vegetable (except Potato) and Melon Farming
$3.8 million
111310
Orange Groves
$4.0 million
111320
Citrus (except Orange) Groves
$4.3 million
111331
Apple Orchards
$4.5 million
111332
Grape Vineyards
$4.0 million
111333
Strawberry Farming
$5.5 million
111334
Berry (except Strawberry) Farming
$3.8 million
111335
Tree Nut Farming
$3.8 million
111336
Fruit and Tree Nut Combination Farming
$5.0 million
111339
Other Noncitrus Fruit Farming
$3.5 million
111411
Mushroom Production
$4.5 million
111419
Other Food Crops Grown Under Cover
$4.5 million
111421
Nursery and Tree Production
$3.3 million
111422
Floriculture Production
$3.8 million
111910
Tobacco Farming
$2.5 million
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EPA's SBAR Panel Outreach Meeting with Small Entity Representatives on Proposed
Rulemaking for n-Methylpyrrolidone (NMP) under TSCA Section 6(a)
NAICS
NAICS Description
SBASize Standard
111920
Cotton Farming
$3.3 million
111930
Sugarcane Farming
$5.0 million
111940
Hay Farming
$2.5 million
111991
Sugar Beet Farming
$2.5 million
111992
Peanut Farming
$2.5 million
111998
All Other Miscellaneous Crop Farming
$2.5 million
236115
New Single-family Housing Construction (Except For-Sale Builders)
$45.0 m
llion
236116
New Multifamily Housing Construction (except For-Sale Builders)
$45.0 m
11 ion
236117
New Housing For-Sale Builders
$45.0 m
llion
236118
Residential Remodelers
$45.0 m
llion
236210
Industrial Building Construction
$45.0 m
llion
236220
Commercial and Institutional Building Construction
$45.0 m
llion
237110
Water and Sewer Line and Related Structures Construction
$45.0 m
llion
237120
Oil and Gas Pipeline and Related Structures Construction
$45.0 m
llion
237130
Power and Communication Line and Related Structures Construction
$45.0 m
llion
237310
Highway, Street, and Bridge Construction
$45.0 m
llion
237990
Other Heavy and Civil Engineering Construction
$45.0 m
llion
238110
Poured Concrete Foundation and Structure Contractors
$19.0 m
llion
238120
Structural Steel and Precast Concrete Contractors
$19.0 m
llion
238130
Framing Contractors
$19.0 m
llion
238190
Other Foundation, Structure, and Building Exterior Contractors
$19.0 m
llion
238210
Electrical Contractors and Other Wiring Installation Contractors
$19.0 m
llion
238220
Plumbing, Heating, and Air-Conditioning Contractors
$19.0 m
llion
238290
Other Building Equipment Contractors
$22.0 m
llion
238310
Drywall and Insulation Contractors
$19.0 m
llion
238320
Painting and Wall Covering Contractors
$19.0 m
llion
238330
Flooring Contractors
$19.0 m
llion
238910
Site Preparation Contractors
$19.0 m
llion
238990
All Other Specialty Trade Contractors
$19.0 m
llion
313210
Broadwoven Fabric Mills
1,000 employees
313320
Fabric Coating Mills
1,000 employees
316110
Leather and Hide Tanning and Finishing
800 employees
316210
Footwear Manufacturing
1,000 employees
321912
Cut Stock, Resawing Lumber, and Planing
500 employees
322220
Paper Bag and Coated and Treated Paper Manufacturing
750 employees
323111
Commercial Printing (except Screen and Books)
650 employees
323113
Commercial Screen Printing
500 employees
323117
Books Printing
1,250 employees
323120
Support Activities for Printing
550 employees
324110
Petroleum Refineries
1,500 employees
324191
Petroleum Lubricating Oil and Grease Manufacturing
900 employees
325110
Petrochemical Manufacturing
1,300 employees
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EPA's SBAR Panel Outreach Meeting with Small Entity Representatives on Proposed
Rulemaking for n-Methylpyrrolidone (NMP) under TSCA Section 6(a)
NAICS
NAICS Description
SBASize Standard
325120
Industrial Gas Manufacturing
1,200 employees
325180
Other Basic Inorganic Chemical Manufacturing
1,000 employees
325199
All Other Basic Organic Chemical Manufacturing
1,250 employees
325199
All Other Basic Organic Chemical Manufacturing
1,250 employees
325211
Plastics Material And Resin Manufacturing
1,250 employees
325220
Artificial and Synthetic Fibers and Filaments Manufacturing
1,050 employees
325311
Nitrogenous Fertilizer Manufacturing
1,050 employees
325412
Pharmaceutical Preparation Manufacturing
1,300 employees
325510
Paint And Coating Manufacturing
1,000 employees
325520
Adhesive Manufacturing
550 employees
325611
Soap And Other Detergent Manufacturing
1,100 employees
325612
Polish and Other Sanitation Good Manufacturing
900 employees
325612
Polish and Other Sanitation Good Manufacturing
900 employees
All Other Miscellaneous Chemical Product And Preparation
325998
Manufacturing
650 employees
Urethane and Other Foam Product (except Polystyrene)
326150
Manufacturing
750 employees
326199
All Other Plastics Product Manufacturing
750 employees
327390
Other Concrete Product Manufacturing
500 employees
327910
Abrasive Product Manufacturing
900 employees
331110
Iron and Steel Mills and Ferroalloy Manufacturing
1,500 employees
331210
Iron and Steel Pipe and Tube Manufacturing from Purchased Steel
1,000 employees
331221
Rolled Steel Shape Manufacturing
1,000 employees
331222
Steel Wire Drawing
1,000 employees
331313
Alumina Refining and Primary Aluminum Production
1,300 employees
331314
Secondary Smelting and Alloying of Aluminum
750 employees
331315
Aluminum Sheet, Plate, and Foil Manufacturing
1,400 employees
331318
Other Aluminum Rolling, Drawing, and Extruding
750 employees
331410
Nonferrous Metal (except Aluminum) Smelting and Refining
1,000 employees
331420
Copper Rolling, Drawing, Extruding, and Alloying
1,050 employees
Nonferrous Metal (except Copper and Aluminum) Rolling, Drawing,
331491
and Extruding
900 employees
Secondary Smelting, Refining, and Alloying of Nonferrous Metal
331492
(except Copper and Aluminum)
850 employees
331511
Iron Foundries
1,000 employees
331512
Steel Investment Foundries
1,050 employees
331513
Steel Foundries (except Investment)
700 employees
331523
Nonferrous Metal Die-Casting Foundries
700 employees
331524
Aluminum Foundries (except Die-Casting)
550 employees
331529
Other Nonferrous Metal Foundries (except Die-Casting)
500 employees
332111
Iron and Steel Forging
750 employees
332112
Nonferrous Forging
950 employees
332114
Custom Roll Forming
600 employees
A2-104
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EPA's SBAR Panel Outreach Meeting with Small Entity Representatives on Proposed
Rulemaking for n-Methylpyrrolidone (NMP) under TSCA Section 6(a)
NAICS
NAICS Description
SBASize Standard
332117
Powder Metallurgy Part Manufacturing
550 employees
Metal Crown, Closure, and Other Metal Stamping (except
332119
Automotive)
500 employees
Metal Kitchen Cookware, Utensil, Cutlery, and Flatware (except
332215
Precious) Manufacturing
1,000 employees
332216
Saw Blade and Handtool Manufacturing
750 employees
332311
Prefabricated Metal Building and Component Manufacturing
750 employees
332312
Fabricated Structural Metal Manufacturing
500 employees
332313
Plate Work Manufacturing
750 employees
332321
Metal Window and Door Manufacturing
750 employees
332322
Sheet Metal Work Manufacturing
500 employees
332323
Ornamental and Architectural Metal Work Manufacturing
500 employees
332410
Power Boiler and Heat Exchanger Manufacturing
750 employees
332420
Metal Tank (Heavy Gauge) Manufacturing
750 employees
332431
Metal Can Manufacturing
1,500 employees
332439
Other Metal Container Manufacturing
600 employees
332510
Hardware Manufacturing
750 employees
332613
Spring Manufacturing
600 employees
332618
Other Fabricated Wire Product Manufacturing
500 employees
332710
Machine Shops
500 employees
332721
Precision Turned Product Manufacturing
500 employees
332722
Bolt, Nut, Screw, Rivet, and Washer Manufacturing
600 employees
332811
Metal Heat Treating
750 employees
Metal Coating, Engraving (except Jewelry and Silverware), and Allied
332812
Services to Manufacturers
600 employees
332813
Electroplating, Plating, Polishing, Anodizing, and Coloring
500 employees
332911
Industrial Valve Manufacturing
750 employees
332912
Fluid Power Valve and Hose Fitting Manufacturing
1,000 employees
332913
Plumbing Fixture Fitting and Trim Manufacturing
1,000 employees
332919
Other Metal Valve and Pipe Fitting Manufacturing
750 employees
332991
Ball and Roller Bearing Manufacturing
1,250 employees
332992
Small Arms Ammunition Manufacturing
1,300 employees
332993
Ammunition (except Small Arms) Manufacturing
1,500 employees
332994
Small Arms, Ordnance, and Ordnance Accessories Manufacturing
1,000 employees
332996
Fabricated Pipe and Pipe Fitting Manufacturing
550 employees
332999
All Other Miscellaneous Fabricated Metal Product Manufacturing
750 employees
333111
Farm Machinery and Equipment Manufacturing
1,250 employees
Lawn and Garden Tractor and Home Lawn and Garden Equipment
333112
Manufacturing
1,500 employees
333120
Construction Machinery Manufacturing
1,250 employees
333131
Mining Machinery and Equipment Manufacturing
900 employees
333132
Oil and Gas Field Machinery and Equipment Manufacturing
1,250 employees
333241
Food Product Machinery Manufacturing
500 employees
A2-105
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EPA's SBAR Panel Outreach Meeting with Small Entity Representatives on Proposed
Rulemaking for n-Methylpyrrolidone (NMP) under TSCA Section 6(a)
NAICS
NAICS Description
SBASize Standard
333242
Semiconductor Machinery Manufacturing
1,500 employees
333243
Sawmill, Woodworking, and Paper Machinery Manufacturing
550 employees
333244
Printing Machinery and Equipment Manufacturing
750 employees
333249
Other Industrial Machinery Manufacturing
750 employees
333314
Optical Instrument and Lens Manufacturing
1,000 employees
333316
Photographic and Photocopying Equipment Manufacturing
1,000 employees
333318
Other Commercial and Service Industry Machinery Manufacturing
1,000 employees
Industrial and Commercial Fan and Blower and Air Purification
333413
Equipment Manufacturing
500 employees
333414
Heating Equipment (except Warm Air Furnaces) Manufacturing
500 employees
Air-Conditioning and Warm Air Heating Equipment and Commercial
333415
and Industrial Refrigeration Equipment Manufacturing
1,250 employees
333511
Industrial Mold Manufacturing
500 employees
333514
Special Die and Tool, Die Set, Jig, and Fixture Manufacturing
500 employees
333515
Cutting Tool and Machine Tool Accessory Manufacturing
500 employees
333517
Machine Tool Manufacturing
500 employees
333519
Rolling Mill and Other Metalworking Machinery Manufacturing
500 employees
333611
Turbine and Turbine Generator Set Units Manufacturing
1,500 employees
333612
Speed Changer, Industrial High-Speed Drive, and Gear Manufacturing
750 employees
333613
Mechanical Power Transmission Equipment Manufacturing
750 employees
333618
Other Engine Equipment Manufacturing
1,500 employees
333912
Air and Gas Compressor Manufacturing
1,000 employees
Measuring, Dispensing, and Other Pumping Equipment
333914
Manufacturing
750 employees
333921
Elevator and Moving Stairway Manufacturing
1,000 employees
333922
Conveyor and Conveying Equipment Manufacturing
500 employees
Overhead Traveling Crane, Hoist, and Monorail System
333923
Manufacturing
1,250 employees
Industrial Truck, Tractor, Trailer, and Stacker Machinery
333924
Manufacturing
900 employees
333991
Power-Driven Handtool Manufacturing
950 employees
333992
Welding and Soldering Equipment Manufacturing
1,250 employees
333993
Packaging Machinery Manufacturing
600 employees
333994
Industrial Process Furnace and Oven Manufacturing
500 employees
333995
Fluid Power Cylinder and Actuator Manufacturing
800 employees
333996
Fluid Power Pump and Motor Manufacturing
1,250 employees
333997
Scale and Balance Manufacturing
700 employees
333999
All Other Miscellaneous General Purpose Machinery Manufacturing
700 employees
334111
Electronic Computer Manufacturing
1,250 employees
334112
Computer Storage Device Manufacturing
1,250 employees
Computer Terminal and Other Computer Peripheral Equipment
334118
Manufacturing
1,000 employees
334210
Telephone Apparatus Manufacturing
1,250 employees
A2-106
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EPA's SBAR Panel Outreach Meeting with Small Entity Representatives on Proposed
Rulemaking for n-Methylpyrrolidone (NMP) under TSCA Section 6(a)
NAICS
NAICS Description
SBASize Standard
Radio and Television Broadcasting and Wireless Communications
334220
Equipment Manufacturing
1,250 employees
334290
Other Communications Equipment Manufacturing
800 employees
334310
Audio and Video Equipment Manufacturing
750 employees
334413
Semiconductor And Related Device Manufacturing
1,250 employees
334510
Electromedical and Electrotherapeutic Apparatus Manufacturing
1,250 employees
Search, Detection, Navigation, Guidance, Aeronautical, and Nautical
334511
System and Instrument Manufacturing
1,350 employees
Automatic Environmental Control Manufacturing for Residential,
334512
Commercial, and Appliance Use
650 employees
Instruments and Related Products Manufacturing for Measuring,
334513
Displaying, and Controlling Industrial Process Variables
750 employees
334514
Totalizing Fluid Meter and Counting Device Manufacturing
850 employees
Instrument Manufacturing for Measuring and Testing Electricity and
334515
Electrical Signals
750 employees
334516
Analytical Laboratory Instrument Manufacturing
1,000 employees
334517
Irradiation Apparatus Manufacturing
1,200 employees
334519
Other Measuring and Controlling Device Manufacturing
600 employees
334613
Blank Magnetic and Optical Recording Media Manufacturing
1,250 employees
334614
Software and Other Prerecorded Compact Disc, Tape, and Record
Reproducing
1,250 employees
335110
Electric Lamp Bulb and Part Manufacturing
1,250 employees
335121
Residential Electric Lighting Fixture Manufacturing
750 employees
335122
Commercial, Industrial and Institutional Electric Lighting Fixture
Manufacturing
600 employees
335129
Other Lighting Equipment Manufacturing
1,250 employees
335210
Small Electrical Appliance Manufacturing
1,500 employees
335220
Major Household Appliance Manufacturing
1,500 employees
335311
Power, Distribution, and Specialty Transformer Manufacturing
800 employees
335312
Motor and Generator Manufacturing
1,250 employees
335313
Switchgear and Switchboard Apparatus Manufacturing
1,250 employees
335314
Relay and Industrial Control Manufacturing
750 employees
335911
Storage Battery Manufacturing
1,250 employees
335912
Primary Battery Manufacturing
1,250 employees
335921
Fiber Optic Cable Manufacturing
1,000 employees
335929
Other Communication and Energy Wire Manufacturing
1,000 employees
335931
Current-Carrying Wiring Device Manufacturing
600 employees
335932
Noncurrent-Carrying Wiring Device Manufacturing
1,000 employees
335991
Carbon and Graphite Product Manufacturing
900 employees
All Other Miscellaneous Electrical Equipment and Component
335999
Manufacturing
600 employees
336111
Automobile Manufacturing
1,500 employees
336112
Light Truck and Utility Vehicle Manufacturing
1,500 employees
A2-107
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EPA's SBAR Panel Outreach Meeting with Small Entity Representatives on Proposed
Rulemaking for n-Methylpyrrolidone (NMP) under TSCA Section 6(a)
NAICS
NAICS Description
SBASize Standard
336120
Heavy Duty Truck Manufacturing
1,500 employees
336211
Motor Vehicle Body Manufacturing
1,000 employees
336212
Truck Trailer Manufacturing
1,000 employees
336213
Motor Home Manufacturing
1,250 employees
336214
Travel Trailer and Camper Manufacturing
1,000 employees
336310
Motor Vehicle Gasoline Engine and Engine Parts Manufacturing
1,050 employees
336320
Motor Vehicle Electrical and Electronic Equipment Manufacturing
1,000 employees
Motor Vehicle Steering and Suspension Components (except Spring)
336330
Manufacturing
1,000 employees
336340
Motor Vehicle Brake System Manufacturing
1,250 employees
336350
Motor Vehicle Transmission and Power Train Parts Manufacturing
1,500 employees
336360
Motor Vehicle Seating and Interior Trim Manufacturing
1,500 employees
336370
Motor Vehicle Metal Stamping
1,000 employees
336390
Other Motor Vehicle Parts Manufacturing
1,000 employees
336411
Aircraft Manufacturing
1,500 employees
336412
Aircraft Engine and Engine Parts Manufacturing
1,500 employees
336413
Other Aircraft Parts and Auxiliary Equipment Manufacturing
1,250 employees
336413
Other Aircraft Part and Auxiliary Equipment Manufacturing7
1,250 employees
336414
Guided Missile and Space Vehicle Manufacturing
1,300 employees
Guided Missile and Space Vehicle Propulsion Unit and Propulsion Unit
336415
Parts Manufacturing
1,250 employees
Other Guided Missile and Space Vehicle Parts and Auxiliary
336419
Equipment Manufacturing
1,050 employees
336510
Railroad Rolling Stock Manufacturing
1,500 employees
337110
Wood Kitchen Cabinet and Counter Top Manufacturing
750 employees
337122
Nonupholstered Wood Household Furniture Manufacturing
750 employees
339112
Surgical and Medical Instrument Manufacturing
1,000 employees
339113
Surgical Appliance and Supplies Manufacturing
800 employees
339114
Dental Equipment and Supplies Manufacturing
750 employees
339115
Ophthalmic Goods Manufacturing
1,000 employees
339116
Dental Laboratories
500 employees
339950
Sign Manufacturing
500 employees
339999
All Other Miscellaneous Manufacturing
550 employees
423120
Motor Vehicle Supplies and New Parts Merchange Wholesalers
200 employees
423220
Home Furnishing Merchant Wholesalers
100 employees
423330
Roofing, Siding, and Insulation Material Merchant Wholesalers
225 employees
423390
Other Construction Material Merchant Wholesalers
100 employees
423490
Other Professional Equipment and Supplies Merchant Wholesalers
150 employees
Electrical Apparatus and Equipment, Wiring Supplies, and Related
423610
Equipment Merchant Wholesalers
200 employees
Electrical And Electronic Appliance, Television, And Radio Set
423620
Merchant Wholesalers
225 employees
423840
Industrial Supplies Merchant Wholesalers
125 employees
A2-108
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EPA's SBAR Panel Outreach Meeting with Small Entity Representatives on Proposed
Rulemaking for n-Methylpyrrolidone (NMP) under TSCA Section 6(a)
NAICS
NAICS Description
SBASize Standard
423850
Service Establishment Equipment and Supplies Merchant Wholesalers
125 employees
423990
Other Miscellaneous Durable Goods Merchant Wholesalers
100 employees
424690
Other Chemical And Allied Products Merchant Wholesalers
175 employees
424710
Petroleum Bulk Stations and Terminals
225 employees
424720
Petroleum and Petroleum Products Merchant Wholesalers (except
Bulk Stations and Terminals)
200 employees
424910
Farm Supplies Merchant Wholesalers
200 employees
441110
Automobile Dealers
200 employees
441110
New Car Dealers
200 employees
441120
Used Car Dealers
$30.5 million
441310
Automotive Parts and Accessories Stores
$28.5 million
442110
Furniture Stores
$25 million
453310
Used Merchandise Stores
$14 million
453920
Art Dealers
$16.5 million
453998
All Other Miscellaneous Store Retailers (Except Tobacco Stores)
$11.5 million
488410
Motor Vehicle Towing
$9.0 million
523930
Investment Advice
$47 million
531190
Lessors of Other Real Estate Property9
$34.0 million
541330
Engineering Services
$25.5 million
541380
Testing Laboratories
$19.0 million
561110
Office Administrative Services
$12.5 million
561210
Facilities Support Services
$47.0 million
561720
Janitorial Services
$22.0 million
561740
Carpet and Upholstery Cleaning Services
$8.5 million
562211
Hazardous Waste Treatment and Disposal
$47.0 million
562212
Solid Waste Landfill
$47.0 million
562213
Solid Waste Combustors and Incinerators
$47.0 million
562219
Other Nonhazardous Waste Treatment and Disposal
$47.0 million
562920
Materials Recovery Facilities
$25.0 million
711510
Independent Artists, Writers, and Performers
$9.0 million
712110
Museums
$34.0 million
811111
General Automotive Repair
$9.0 million
811112
Automotive Exhaust System Repair
$9 million
811113
Automotive Transmission Repair
$9 million
811118
Other Automotive Mechanical and Electrical Repair and Maintenance
$9 million
811121
Automotive Body, Paint, and Interior Repair and Maintenance
$9.0 million
811121
Automotive Body, Paint and Interior Repair and Maintenance
$9.0 million
811122
Automotive Glass Replacement Shops
$17.5 million
811191
Automotive Oil Change and Lubrication Shops
$11.0 million
811192
Car Washes
$9.0 million
811198
All Other Automotive Repair and Maintenance
$10.0 million
811412
Appliance Repair and Maintenance
$19.0 million
A2-109
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EPA's SBAR Panel Outreach Meeting with Small Entity Representatives on Proposed
Rulemaking for n-Methylpyrrolidone (NMP) under TSCA Section 6(a)
NAICS
NAICS Description
SBASize Standard
811420
Reupholstery and Furniture Repair
$9.0 million
811430
Footwear and Leather Goods Repair
$9.0 million
811490
Other Personal and Household Goods Repair and Maintenance
$9.0 million
812310
Coin-Operated Laundries and Drycleaners
$13.0 million
812320
Drycleaning and Laundry Services (except Coin-Operated)
$8.0 million
812331
Linen Supply
$40.0 million
812332
Industrial Launderers
$47.0 million
Source: U.S. Small Business Administration Table of Small Business Size Standards Available at:
https://www. sba.gov/document/suDDort-table-size-standards
A2-110
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EPA's SBAR Panel Outreach Meeting with Small Entity Representatives on Proposed
Rulemaking for n-Methylpyrrolidone (NMP) under TSCA Section 6(a)
Table 2: Small Entities Potentially Affected
Use Category
Estimated
Number of
Firms Using
NMP
Percent of
Firms That
Are Small
Estimated
Number of
Small Firms
Using NMP
Manufacture/Import
49
24%
12
Repackaging
32
95%
30
Processing: incorporation into a formulation, mixture
or reaction product
70
59%
41
Lithium ion battery manufacturing
55
91%
50
Waste handling, disposal, treatment, and recycling
1,787
91%
1,620
Plastic and resin product manufacturing
983
93%
917
Textiles, leather, and apparel manufacturing
33
95%
31
Processing aids in petrochemical manufacturing, oil
and gas activities, and functional fluids (closed
systems)
479
89%
427
Laboratory use
56
93%
51
Paints and coatings
13,574
97%
13,198
Paint, coating, and adhesive removers
4,296
90%
3,886
Electronic product and semiconductor manufacturing
3,473
94%
3,266
Adhesives and sealants
7,012
97%
6,814
Cleaning and furniture care products
2,702
99%
2,665
Ink, toner, and colorant products
114
99%
113
Soldering
2,768
98%
2,711
Fertilizer and other agricultural chemical
manufacturing
26,265
99%
26,017
Lubricants and lubricant additives
-
-
-
Anti-freeze and de-icing
-
-
-
Total
63,748
97%
61,850
A2-111
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Related Regulations (ERA, Federal, State, and International)
Same as Pre-Panel version, see Appendix Al, p.114
A2-112
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SER Questions for Discussion
Same as Pre-Panel version, see Appendix Al, p.123
A2-113
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Personal Protective Equipment Respirator System Per Worker Unit Cost
Breakdown
Same as Pre-Panel version, see Appendix Al, p.132
A2-114
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Potential Regulatory Options and Estimated Costs (updated from Pre-
Panel version)
A2-115
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EPA's SBAR Panel Outreach Meeting with Small Entity Representatives on Proposed
Rulemaking for n-Methylpyrrolidone (NMP) under TSCA Section 6(a)
Potential Regulatory Options and Estimated Costs
Any regulatory requirement could be used alone or in combination to the extent necessary so
that NMP no longer presents an unreasonable risk under its condition of use. Additionally, under
TSCA section 6(g), EPA may propose a time-limited exemption for specific conditions of use
provided certain criteria are met.1
When considering practicability and a reasonable transition period, EPA works to account for
various factors such as supply chains, availability of alternatives, and time neededfor
recertification, testing, and retrofitting. Any information on historical timelines from industry on
replacing chemicals in the past are especially helpful in determining a reasonable transition
period, along with the information mentioned in the previous sentence.
Unlike some of the other chemicals currently undergoing risk management under TSCA section
6, EPA is not considering an airborne concentration limit for NMP and is focusing on dermal
protection measures. The 2020 risk evaluation for NMP and revised unreasonable risk
determination found that the unreasonable risk of injury to human health is driven by direct
dermal contact with liquid NMP.
EPA has not made a decision at this point about what regulatory options to propose.
Nonetheless, EPA 's primary performance metric for eliminating the unreasonable risk of injury
to human health is to eliminate or reduce significantly direct dermal contact with NMP. EPA is
considering the following regulatory options and seeking feedback on the impacts of applying
one or more of the following regulatory options to address the unreasonable risk from NMP.
Concentration Limit
• A risk management option that would restrict the concentration or weight fraction within
the formulation.
o For example, if scientific analysis based on the 2020 Risk Evaluation2 supported
it, EPA could limit the percentage amount of the chemical in the formulation if
that percentage addressed the unreasonable risk and the formulation was still
efficacious.
o In the 2020 Risk Evaluation for NMP, EPA identified the expected weight
fraction of NMP in liquid products based on publicly available information,
public comments, and available products on the market (see separate handout:
Information on Weight Fractions of NMP Evaluated in the 2020 Risk Evaluation).
If ranges of NMP in formulations were identified, EPA generally assessed the
1 In order to propose an exemption under TSCA section 6(g), EPA must find that the specific condition of use is a
critical or essential use for which no technically and economically feasible safer alternative is available; compliance
with the rule would significantly disrupt the national economy, national security, or critical infrastructure; or the
specific condition of use, as compared to alternatives, provides a substantial benefit to health, the environment, or
public safety. In proposing the exemption, EPA must provide a time limit for the exemption; analyze the need for
the exemption and make the analysis public; and include interim conditions to protect health and the environment.
2 Available at https://www.regulations.gov/document/EPA-HQ-OPPT-2019-0236-0081.
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lower bound of the range as the central tendency and the upper bound of the range
as the high end.
¦ Example: EPA identified and assessed the commercial use of NMP in
paints, coatings, adhesives and sealants based on products with 2-53%
NMP. At the high-end concentrations, in the expected occupational
exposure scenarios, this condition of use drives the unreasonable risk.
¦ Example: EPA identified and assessed the commercial use of NMP in
metal finishing products with 60-90% NMP. At these concentrations, in
the expected occupational exposure scenarios, this condition of use drives
the unreasonable risk.
• There is uncertainty if lowering the concentration limit may impact efficacy of the
products. For a concentration or weight fraction limit to address the unreasonable risk, it
would need to be lower than those that drove the unreasonable risk in the risk evaluation.
Prescriptive Engineering Controls
• A risk management option that would reduce worker exposure by requiring specific
physical changes to the workplace to eliminate or reduce direct dermal contact.
o Examples: installing additional or different equipment, such as enclosed
transfer liquid lines, closed loop container systems or a laboratory type fume
hood, to reduce the exposure to the chemical.
• EPA's confidence that the unreasonable risk from NMP can be addressed is highest for
highly standardized and industrialized settings, such as where NMP is used in a closed-
loop system.
Prescriptive Administrative Controls
• A risk management option that would reduce worker exposure by requiring processes or
procedures in the workplace to eliminate or reduce direct dermal contact.
o Examples: Limit access to work areas (restricted areas) or confining
operations (enclosed areas)
Prescriptive PPE Controls
• A risk management option that would require the use of specific PPE to minimize
exposure. This may limit flexibility for the regulated entity.
o Some examples of potential PPE that could contribute to reducing the
unreasonable risk are listed separately in in Appendix F of the 2020 final risk
evaluation, as well as the Potential Costs of Regulatory Options table later in this
document.
• Requiring the use of dermal and inhalation PPE that provides an impervious barrier in
combination with a set concentration limit of NMP would allow more flexibility for
regulated entities to mitigate unreasonable risk.
2
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• EPA anticipates that PPE would need to be combined with training and other controls in
order to address the unreasonable risk from NMP.
Combination of Controls (non-prescriptive)
• A combination of risk management approaches for conditions of use where strict
industrial practices may already exist. Enables users to determine how to most effectively
separate, distance, physically remove, or isolate workers from direct handling of NMP or
from contact with equipment/materials for which NMP may exist based on what works
best for their workplace and the ability to combine prescriptive controls
• This approach would eliminate direct dermal contact in accordance with the Pollution
Prevention Act and NIOSH hierarchy of controls.
• This approach could also include engineering and administrative controls to reduce
exposure.
• If direct dermal contact could not be eliminated using elimination, substitution,
engineering controls, or administrative controls, EPA could require personal protective
equipment that provides an impervious barrier.
• Examples: Automation, barriers, or design of tools
Prohibition
• EPA could include prohibition on manufacturing, processing, distribution, use, or
disposal for specific conditions of use or the chemical as a whole.
o For example, alternatives to NMP in paint and coating removal include solvent-
based alternatives like n-ethylpyrrolidone (NEP), benzyl alcohol, and other
methyl acetate-based formulations, or process-based alternatives like heat and
sanding.
¦ https://dtsc.ca.gov/wp-content/uploads/sites/31/2019/09/Final-NMP-Paint-
Stripper-Graffiti-Remover_Profile.pdf
• EPA requests data and feedback about availability and viability of NMP alternatives,
testing and analysis that SERs have completed of potential alternatives, the cost impacts
of SERs switching to alternatives, and the overall impacts to SERs' businesses if NMP is
prohibited.
Regulate the Manufacturing, Processing, and/or Distribution
• A risk management option for industrial, commercial, and consumer conditions of use.
These authorities allow EPA to regulate at key points, including the manufacturing,
processing, and distribution in commerce of a chemical or product in the supply chain.
Regulatory options applied broadly with other restrictions
• Recordkeeping and downstream notification
o For example, EPA could require manufacturers, processors, and distributors to
provide downstream notification to help ensure regulatory information {i.e.,
prohibition) reaches all users in the supply chain.
3
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o Additionally, as an example, EPA could require manufacturers, processors, and
distributors to maintain ordinary business records and an exposure control plan.
• Monitoring, labeling, and container sizes -
o For monitoring, EPA could require initial or periodic monitoring of occupational
exposure or for concentration limits.
o For labeling, EPA could require that a prominent label be securely attached to
each container with specific directions, limitation, and precautions, or that
describes the health endpoints. EPA could also require labeling products to
indicate that they should not be used by consumers or to describe other regulatory
requirements.
o For container sizes, EPA could require a minimum or maximum container size
(e.g., 32 ounce container, 55 gallon drum) to reduce likelihood of purchase by
certain types of users (consumers or commercial users)
• Limited access program
o For example, restrict distribution of a chemical or product only to certain users,
under a limited access program that could require training and certification, or
restrict distribution only to users with certain equipment or type of facilities.
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Potential Costs of Regulatory Options
Type of Cost
Estimated Compliance
Cost
Notes
Prohibition of manufacturing,
processing, and distribution
Varies with condition of
use
Cost will vary by condition of use. Potential
activities could include changes in process and
equipment, costs of alternatives3, reformulation (see
below), and more. Requires input from potentially
regulated entities.
Prohibition of Use
Reformulation of product to
eliminate NMP
Varies with condition of
use
$60,000-$ 102,000 per
product
Cost will vary by condition of use. Potential
activities could include changes in process and
equipment, costs of alternatives, reformulation (see
below), and more. Requires input from potentially
regulated entities.
Costs will vary by condition of use and will be
dependent on reformulation approach. Requires input
from potentially regulated entities.
Substitute Products (price per
ounce)
Varies with condition of
use
DMSO:
$0.73/ounce (vol)
Furfural:
$0.70/ounce (vol)
Phenol (hydroxy
benzene):
$1.30/ounce (wt)
Would vary by price of NMP per ounce vs.
substitutes, as well as the differences in efficacy of
the substitute products. This is only a material cost
and excludes changes in equipment, technology,
training, testing, etc. Example prices are from a
scientific retailer. Requires input from potentially
regulated entities.
Reformulation of product to
reduce NMP concentration
$17,000 per product
Costs reflect dilution reformulation approach.
Requires input from potentially regulated entities.
Engineering/Administrative
Controls
Varies by control type
and needs of user
Requires input from potentially regulated entities
Personal Protective Equipment
(PPE) for NMP (respirators)
APF 10: $1,800
APF25: $1,300
APF 50: $1,700
APF 1000: $1,100
APF 10000: $2,000
Annualized costs are per person and include
purchase of equipment (including filters), training,
fit-testing, and medical clearance. The unit costs
include a written respiratory program and equipment
cleaning. Does not include existing PPE use nor PPE
replacement due to employee turn-over. Includes
both purified and supplied air respirators.
3 TSCA section 6(c)(2)(C) requires EPA "... 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.. .to the extent practicable, whether technically and economically feasible alternatives that
benefit health or the environment, compared to the use so proposed to be prohibited or restricted, will be reasonably
available as a substitute when the proposed prohibition or other restriction takes effect."
5
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Type of Cost
Estimated Compliance
Cost
Notes
Personal Protective Equipment
(PPE) for NMP (dermal)
Reusable gloves: $6-$55
Disposable gloves: $0.50
Reusable apron: $25-$34
Disposable apron: $4
Reusable glove costs are per pair of butyl, laminated
polyethylene, neoprene, and natural rubber/latex
gloves. Disposable glove costs are per pair of nitrile
gloves. Disposable nitrile gloves are not used alone,
but in combination with the reusable gloves.
Reusable apron costs are per nitrile and neoprene
apron. Disposable apron costs are per polyethylene
apron.
Combination of controls (non-
prescriptive)
Annualized costs of
Exposure control plan:
$560-$630 per facility
costs
$35 per worker costs
One-time costs of
Exposure control plan:
40 hours one time cost to
develop plan: $3,730 per
facility
4 hours annual cost for
regular inspections: $370
per facility per year
0.43 hours annual
recordkeeping: $40 per
facility per year
Costs of engineering
controls, monitoring, or
PPE varies by control
type and needs of user
See PPE costs for glove
and apron costs
Non-prescriptive approach would likely include
development of an exposure control plan. Costs
include costs for conducting regular inspections, PPE
program plan documentation, records of plan
implementation, and records of dermal exposure.
Includes both per-facility and per-worker costs.
Costs would depend on baseline PPE and dermal
exposure control plan activities.
Product Label or Warnings
$830- $8,900 per
product, one time cost
Costs will vary by condition of use. Potential
activities may include graphic design changes, plate
changes, discarded inventory, and labor.
Container Sizes
$9,500-$47,500 per
product, one time cost
A change in container size would lead to costs at the
lower end while a packaging material change would
likely result in costs at the higher end.
Substitute Methods
Varies by job labor rate
This will primarily be labor cost and cost of
alternative equipment.
Recordkeeping
$218-$340 per firm
Ongoing annual labor and material costs associated
with documentation of ordinary business records.
Downstream Notification
$121-$138per product,
one time cost
Costs are per product and include labor and material
costs to update a product's safety data sheet (SDS).
6
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Tj pc iif Cosl
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Notes
Limited Access Program
Varies with condition of
use and type of
distributor
Would vary by type of requirements for certification
and any distribution processes or restrictions already
in place.
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Information on Weight Fractions of NMP Evaluated in the 2020 Risk
Evaluation
Same as Pre-Panel version, see Appendix Al, p.145
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Key Takeaways from Pre-Panel Outreach Meeting
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Key Takeaways from Pre-Panel Outreach Meeting
On March 28, 2023, EPA conducted a Pre-Panel outreach meeting with potential small entity
representatives (SERs). Representatives from the Small Business Administration (SBA) and
Office of Management and Budget (OMB) also participated. A total of 9 potential SERs
participated in the meeting. EPA presented an overview of the Small Business Advocacy Review
(SBAR) Panel process and Section 6 of the Toxic Substances Control Act (TSCA), an
explanation of the forthcoming rulemaking, potential regulatory approaches, and cost estimates.
EPA also provided opportunities for questions and feedback. EPA asked the potential SERs to
provide written comments by April 11, 2023. One SER submitted a written comment.
At the Pre-Panel outreach meeting, SERs provided information on the number and type of
entities that would be affected; including descriptions of their processing and/or use of NMP,
their customer base, how their products are used; potential compliance requirements (including
exposure and monitoring reduction, anticipated changes due to future requirements, and
considerations for substitute chemicals), related Federal rules, and potential regulatory flexibility
alternatives (including descriptions of challenges for small businesses and questions for EPA
regarding the regulatory approach). Discussion from SERs focused on several conditions of use
(processing into formulations for pesticides, herbicides, and fungicides and industrial cleaners,
and using NMP as an extraction solvent in re-refining used motor oil); for most of the other
industrial, commercial, and consumer uses of NMP, SERs did not express concerns regarding
restrictions or prohibitions.
Summary of Comments from Potential Small Entity Representatives
Number and Types of Entities Affected
SERs discussed their import, manufacture, processing, and/or use of NMP, their customer base,
and how their products are used. Specifically, SERs described:
• One SER described their business as a lawn care and agricultural fertilizer business that
sells several products that contain NMP. The SER indicated they were looking to phase
NMP out of their products.
• A chemical processor SER described their use of NMP in industrial cleaners. The SER
described how, generally, NMP is blended into industrial cleaners with a final
concentration of 1.5 to 15% NMP in the formula by weight. The SER also described how
they can formulate products to specific consumer requests. The SER estimated that on a
monthly basis, they process about four drums, or 2,000 lbs of NMP.
• Another chemical processor SER described their use of NMP in herbicides, fungicides,
and pesticides. The SER provided an example of how they use NMP in six products
registered under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) with
concentrations of NMP in formulation of some products up to 10% by weight. For other
products, the NMP may be present in the formulation in small amounts. Several of these
U.S. Environmental Protection Agency 1
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products are applied in the field in water-based solutions. The SER described how they
test small volume formulations in a laboratory to complete specified consumer requests.
• A third chemical processor SER described their patented planned use of NMP as an
extraction solvent in re-refining used motor oil. The SER is a start-up company and
described their investment in the process that will use NMP; the investment described
was over $50 million dollars and the SER emphasized how critical NMP is to the planned
re-refining process, in order to yield a higher purity of re-refined oil.
o In a written comment, this SER described in more detail their planned use of
NMP as an extraction solvent in their patented technology that will enable used
motor oil to be re-refined to produce base oils of high purity. The SER described
their business as a "cleantech" company advancing sustainability. The SER in
their comment quantified expected benefits from their technology to re-refine
used motor oil based on expected reductions in carbon dioxide emissions from
used motor oil currently being disposed of improperly of burned as a fuel. The
SER described that in their patented process, NMP is critical, and they are
expecting that it would be used at any future facilities.
Potential Reporting. Recordkeeping, and Compliance Requirements
SERs described their exposure monitoring and reduction practices, anticipated changes due to
potential requirements from EPA, and considerations for substitute chemicals or processes.
Specifically, SERs described, for themselves or their customers:
• One SER who processes NMP into industrial cleaners described their exposure
control practices, which include PPE and engineering controls.
o PPE: The SER described how workers receiving and unloading the NMP (in
55-gallon drums), wear PPE to reduce exposures. The SER described this
PPE as an industrial uniform with standard boots, safety glasses and gloves
for NMP. For other chemicals, the SER described how PPE may include
face shields and chemically-resistant elbow-length gloves.
o Engineering controls: The SER described how, once received, the NMP is
pumped through tubes or vacuum suction devices (such as a diaphragm
pump) into large mixing vessels/tanks (approximately 800 gallons). Once
blended, the formulations are then pumped into totes (standard size is 275
gallons) or drums (55 gallons). The SER noted that outgoing products are
checked with Fourier transform infrared when necessary to identify the
components in the mixture and measure NMP concentration by weight,
rather than manual sampling by workers. This SER indicated their pumps
are cleaned after use by water rinse or emulsifier to remove any remaining
NMP.
U.S. Environmental Protection Agency 2
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• One SER who formulates herbicides, fungicides, and pesticides with NMP
described exposure reduction practices that include PPE, engineering controls, and
administrative controls. The SER also provided insight on potential challenges for
reformulation, and their feedback on potential compliance requirements.
o Exposure controls: The SER described how they receive NMP in 55-gallon
drums. The NMP is transferred to a blending tank that has vents that lead to
carbon scrubbing filters. The SER described how worker protection is
guided by SDS sheets, and that this provides guidance on chemically
resistant material (e.g., barrier PPE) to NMP. The SER explained how
within their internal laboratories, staff use standard PPE such as gloves,
glasses, and lab coats, as well as additional control measures such as fume
hoods. Staff are trained to follow good laboratory practices, and workers all
have undergraduate degrees and experience working in labs. The SER also
described how annual retraining is required.
o Compliance requirements: This SER indicated PPE requirements would be
the least burdensome option for their operations, because engineering
control requirements would incur capital costs. This SER indicated that
reformulating to avoid use of NMP would require additional laboratory
testing and internal document revisions, which would require potentially
one to two years. They indicated concern over the length of time required
for EPA FIFRA registration, which they stated would need to be updated if
their formulation changed.
• One SER who plans to use NMP as an extraction solvent in re-refining used motor
oil described their planned use of pure NMP in what they characterized as a closed
loop system. They expect to achieve this through engineering controls, operations
staff training, reduced entry to the area where NMP is used and the use of warning
signs. They expect to have operations that run continuously unless routine
maintenance is required. The SER described how the NMP would be received in a
large truck, held in a small onsite storage tank, and recycled within their system.
o This SER stated that prohibitions on NMP would have significant negative
impacts on their business, and would require an additional 10 to 15 years of
testing and investment to identify an alternative.
o In a written comment, the SER provided more details. While the SER did
not describe the impact of potential reporting, recordkeeping, and
compliance requirements, the SER did provide information on expected
exposures and plans for minimization of worker risk. In the written
comment, the SER detailed their expected operations and maintenance
manual to track how many employees would be exposed to NMP and for
how long. Re-refinery equipment, including a 60,000 gallon storage tank,
are outside with open ventilation. The SER described how NMP is used in a
Scheibel extraction column to extract low-quality products, aromatics and
polar components from the used motor oil; these components are then
distilled and separated from the desired output. The NMP is regenerated for
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storage and reuse. The SER expects the facility to have four persons per
shift with two outside operators, and that one person per shift would be in
the area with the tank containing NMP. The SER estimated that the person
in the area with the tank would be in that area for no more than one hour a
day, and did not expect inhalation or dermal exposures during normal
operations.
o The SER also plans to maintain industrial hygiene programs and regular
occupational exposure evaluations as part of their worker health and safety
protection plan. The comment further detailed expected protocols for
engineering controls, which would be focused on a closed loop design using
vapor recovery and spill containment systems. Additional engineering
controls would include fully automated processing equipment.
Administrative controls would be implemented through a standard
operating procedure and written instructions for any activity with NMP to
restrict access to the area where NMP is being used. PPE would be fitted
and available to workers, and industrial hygiene programs and regular
occupational exposure evaluations implanted.
• Several SERs discussed alternatives to NMP, and the challenges of using those
alternatives if NMP were prohibited:
o Two SERs (a chemical processor of industrial cleaners, and a chemical
processor of herbicides, fungicides, and pesticides) each identified 1-butyl-
2-pyrrolidone (or n-butylpyrrolidone (NBP), CASRN 3470-98-2)) as an
alternative chemical for NMP but noted that it was less effective than NMP
and required more product, degraded faster than NMP, and is subject to a
TSCA section 5 Significant New Use Rule (SNUR). The SER indicated that
using the chemical subject the SNUR required additional time (with an
estimate of approximately 6-8 months delay to their process). Both SERs
indicated that while they had used this alternative, they returned to using
NMP.
o A chemical processor SER also identified dimethyl sulfoxide (DMSO)
(CASRN 67-68-5) as an alternative to NMP in herbicide and fungicide
formulations, and stated their view that it is not as good as NMP at carrying
chemicals across barriers or solubilizing organic chemicals. This SER noted
it would be challenging to phase out of NMP because it would require lab
work to develop a replacement formulation, two to three years of field and
toxicology testing, and additional time if the reformulated products would
need to be registered under FIFRA. This SER said their products are
intended to have two to three year service lives. The SER estimated the cost
of reformulation could be around $500,000.
o A chemical processor SER noted that generally NMP was the chemical
many processors in the industry had transitioned to as a replacement for
other solvents they described as presenting higher hazards or other concerns
(regrettable substitutes).
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o In a written comment, a SER stated that their use of NMP as an extraction
solved used to upgrade crude oil to base oil could be replaced with other
solvents like furfural (CASRN 98-01-1) or phenol (hydroxy benzene)
(CASRN 108-95-2). The SER described how these alternatives are less
effective than NMP at extracting polar and aromatic compounds, as well as
how, compared to those chemicals, NMP has a lower flammability, lower
volatility, and greater thermal stability. For these reasons, according to the
SER, NMP is essential for their planned process. The SER described
extensive development of their unique process, during which they have
been testing NMP for fifteen years at a cost of over $50 million. Similar to
their comments at the pre-Panel outreach meeting, in written comments the
SER described how prohibition or restriction in concentration of NMP for
this use would severely impair their planned business, and would require 10
to 15 years to identify and integrate alternative chemical into their
extraction and re-refining process.
Related Federal Rules
During the meeting, two SERs mentioned FIFRA registration requirements for NMP as an inert
ingredient in pesticide formulations. The SERs indicated that if NMP were prohibited there
would be cost and testing requirements associated with registration of a new formulation.
In the written comment the chemical processing SER did not mention related Federal rules. The
SER indicated they expect health and safety practices to be enforced as part of typical health and
safety protocols at refineries.
Regulatory Flexibility Alternatives
SERs identified several potential regulatory flexibility alternatives, challenges for small
businesses, and provided recommendations:
• A SER that formulates herbicides, fungicides, and pesticides with NMP stated a
preference for PPE requirements to address unreasonable risks; the SER described
how PPE changes would be less burdensome for their business, because
engineering control requirements would incur capital costs.
• In contrast, a SER who plans to use NMP as an extraction solvent in re-refining
used motor oil stated that administrative or engineering controls would be possible
and preferable. This SER expressed a strong preference for exposure controls that
would prevent a need for prohibition or reductions in concentration.
o In the written comment, this SER advised that EPA should focus the
proposed regulation of NMP on engineering and administrative controls and
PPE requirements instead of prohibitions, imposed concentration limits, or
volume restrictions. This SER stated they did not believe additional
requirements for their facility were needed, due to site specific operating
protocols for health and safety practices including a closed loop system,
engineering controls, rigorous operating procedures, employee/contractor
training, appropriate PPE (including chemically impervious gloves),
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warning signs, restrictions for at-risk personnel.
• Two SERs described considerations for timeframes for implementation of
regulatory restrictions:
o One SER that processes NMP as an inert ingredient in pesticides stated that
reformulating to avoid use of NMP would require additional laboratory
testing and internal document revisions, which would require potentially
one to two years. They indicated concern over the length of time required
for EPA FIFRA registration, which they stated would need to be updated if
their formulation changed.
o A different SER that processes NMP into pesticides provided a separate
estimate of time that would be needed to reformulate products, which would
include lab work to develop a replacement formulation, two to three years
of field and toxicology testing, and additional time if the reformulated
products would need to be registered under FIFRA.
o One SER who plans to use NMP as an extraction solvent in re-refining used
motor oil stated that in the event of a prohibition on NMP for this use, they
expected that 10 to 15 years of testing and investment would be needed to
identify an alternative.
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Pesticide Inert Ingredients Interpretation TSCA and FIFRA
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Pesticide Inert Ingredients Interpretation
This document contains:
1. A letter from EPA to Mark Duvall discussing EPA's interpretation of pesticide inert ingredients
subject to the Toxic Substances Control Act prior to use as an ingredient in pesticide products
regulated separately under the Federal Insecticide, Fungicide, and Rodenticide Act.
2. 42 FR 64586 (Comment 39) from 42 FR 64,572, 64,586 (Dec. 23 1977) available online at
https://www.govinfo.gov/content/pke t ^ I I _ _ o ^ * * _ _ i- If
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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, D.C. 20460
OFFICE OF CHEMICAL SAFETY
AND POLLUTION PREVENTION
Mark N. Duval 1
Beveridge & Diamond
1900 N Street, NW, Suite 100
Washington, DC 20036
Dear Mr. Duvall:
Thank you for your letter of April 26, 2021 requesting clarification as to whether the rule
adopted by the U.S. Environmental Protection Agency (EPA) under the Toxic Substances
Control Act (TSCA) for Phenol, Isopropylated Phosphate (3:1) (PIP (3:1)) is intended to
preclude the processing and distribution of PIP (3:1) for use as an inert ingredient in pesticide
products regulated separately under the Federal Insecticide, Fungicide, and Rodenticide Act
(FIFRA). The citation for the final rule is: 40 C.F.R. §751.407; Phenol, Isopropylated Phosphate
(3:1) (PIP 3:1); Regulation of Persistent, Bioaccumulative, and Toxic Chemicals Under TSCA
section 6(h), 86 Fed. Reg. 894 (January 6, 2021).
In your letter you note that PIP (3:1) is an approved inert ingredient under FIFRA but that such
use of PIP (3:1) as an inert ingredient in a registered pesticide product is not addressed in the
alternative deadlines or exclusions adopted at 40 C.F.R. §751.407(a)(2) or (b). You further note,
citing discussion in the preamble of an EPA 1977 rule, that EPA has taken the position that a
substance intended for use as an inert ingredient in a pesticide product is subject to TSCA, not
FIFRA, until it is actually formulated into the pesticide. You, however, state that "use of PIP
(3:1) by a pesticide formulator as an inert ingredient in a registered pesticide product should not
be directly affected by § 75 1.407, since EPA adopted that rule under TSCA, while pesticide
products are excluded from TSCA regulation and instead subject exclusively to FIFRA." You
cite the exclusion from the definition of "chemical substance" for "any pesticide when
manufactured, processed or distributed in commerce for use as a pesticide" at TSCA §
As you correctly note in your letter, EPA has a longstanding interpretation of TSC A § 3(2)(B)(ii)
that pesticide inert ingredients are subject to TSCA jurisdiction until becoming part of the
pesticide product. See 42 Fed. Reg. 64,572, 64,586 (Dec. 23, 1977) (Comment 39, taking the
position that a raw material, intermediate, or inert ingredient which is not itself a pesticide would
be a chemical substance within the jurisdiction of TSC A and "would come within the jurisdiction
of FIFRA when it becomes a component of a pesticide product"); 5 1 Fed. Reg. 15,096, 15,098
(Apr. 22, 1986) (reaffirming this position). This interpretation has not changed. Thus, the
processing and distribution of PIP (3:1) prior to use by a pesticide formulator as an inert
3(2)(B)(ii).
internet Address (URL) ~ http://www.epa.gov
Recycled/Recyclable ~ Printed with Vegetable Oil Based inks on 100% Postconsumer, Process Chiorine Free Recycled Paper
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ingredient in a registered pesticide product is subject to the newly adopted TSCA regulation for
PIP (3:1).
Again, thank you for your letter. I hope this information has been helpful to you. If you have
additional questions, please contact me, or you can contact Tanya Hodge Mottley, the Director of
the Existing Chemical Risk Management Division at (202) 564-3152.
Sincerely,
Hart man Digitally signed by
ridI Lilian, Hartman,Mark
M a r Date: 2021 -05-25
IVIdllS. 11:26:21 -04'00'
Mark A. Hartman
Deputy Office Director
CC: Tanya Hodge Mottley, EPA/OPPT
A2-134
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6ISH6
RULES AND REGULATIONS
would normally be uuiiit* u situations Bl-
ew ring significant exposure. (a lb* ism of s
iwnri-ii chemical which besomes it psistlelde
Ibm* latter iup»- at conr«m would be ad-
dr«'.l 10e. (40 CFR l«34ib)|3)). an Inter-
mediate substance Intended lot U\r produe-
Una of a pesriude product by chemical rnc-
Won with other substances » not •<»a«id«ed
r pesticide 140 CTH Ifca 4lc)l«) I
The legislative history of TBCA also sup-
port* this in* T5-CA .•,» enacted to pro-
vide protection from harmful chemicals
where legal authority *m previously inade-
quate cumbersome «t Inefficient Congxrss
intended to avoid the possibility that the
n»U from a chemical • ould not be nubjact
to regulation S. H#J> No 64 OM. U4th Cong,.
5edlate, or inert Incredleul which la not
itaelf « peatlclde would, accordingly, be a
chemical (obataii.ee within tbe Jurisdiction of
TftCA. It would come within the Jurisdiction
c* dual
JUilMlctlon of TSCA and l'TKRA That per-
son will mU> be rubject to TSCA TUe luaim-
locr.trer. proc*it»«r. and dlttributof of the
raw material, luterntediata. or inert ingredi-
ent who also miuuractiiret the peetlcide
product will be subject to the JurUtdictlun of
both KU TSCA and >U taflalative history
uontemplaiea 4 a pmu.:lde prcduct. Aa a matter of policy,
hdwever. WA doe* twit intend to tmpoo>
dupiicauv* r«quirement» on thee* tub-
¦uiuom
Comment 40 A substance thould be con-
aide red a loud, food additive, drug. coametlO
or device al the lime that tlic rood and
Dru« Administration irDA| regulate* tbe
»ubatano«.
Reapouae- The Adminiatratc.r agree* wltt^
thia comment. Aa aoon aa the FDA regulates
u product it* manufacture procaaaing, or
dlatributton in commerce solely for a FDA
regulated u*e *111 be excluded from the Jurta-
dlctton of TSCA The FDA Rl<«a aa examples
at auch polnu irt lime when an application
for exemption tor an InvMtlgaUoaal ua«> of
« new drug la submitted iFFDCA &tt&(a);
41 CTH Part 3)2); when an application for
exemption for Invaatlgatlonal uae of a oew
animal drug la submitted iFFDCA 6121a):
31 CFR Fart Si I); and when an application
for exemption for UivaaUgaUoum ,uu> or •
device <* ftubutitted (FFUCA A3(l(gi. 31
CFU Part 81i. *~ propoaed 41 FR M3«.
Auguat 30. 1070).
ComNieai «l [utermedlau. and citajyau
intended solely for uae in the production of a
food, food additive, drug, coametic, or device
are excluded from regulation under TSCA
Response. The Administrator agrees with
thta comment The deOUillona of tlie FFDC'A
provKte that chemical aub In response to this comment. M pro-
vided In a note to the definition. If a «uti-
fttaoce Is manufactured ur imported In
quantitle* of leas tba.ii one thousand pound"
annually. II will be presumed to be for re-
search and development purpcoes if a mar.
ufaelurer wlabas to report for Inclusion on
the inventory a chemical substance which li
manufactured for commercial purposes In
quantities of leas than cme thousand pound-
annually, he must be able to certify that sbs
substance Is used for purposes other than for
rrwaarch snd development. After tbe pubis
cation of the revised Inventory. In oeder to
qualify as a " small quantity for research nr
development ' these quantities munt bs tuted
by, or directly under the supervision of. a
technically qualified individual.
Comment 4S The exemption for "sms'
quantities'* thould not extend to research or
analysis of chemical substances tor the de-
velopment (if a product. TUe c-xeroptli
xl.-uid apply only to rrvearch In a labor*to:
una not to situations where prodoctl.
v .,rleers are at|>ossd-
Response; The Administrator (Usaere
Wllb this comment. The legislative hlsto
of tbe Act msksa clear that Con grew in-
tended the exemption for small quantities
CO exumd to chemical substances in the d«:
vaiopmantal period and nut only to research
chemical* In a laboratory H R Rep. No, (M
1341, 94th Cong,. 3d Sees 38-30 (tlTIfli Th-
Oonirreea contemplated that during the re-
search and cvirelopmcnt phase, a chemi si
substance would be xrlthln the control
lechulcally qualified individual* a'ho would
•ooreclstc the risks from exposure to tt>«
¦tibsuuice and be able U mlnlmlte such rlsin
Tbe regulations provide that a cocnpcmnd v>1l|
only qualify lot the "small quatiiities" c
e-Tit"tlon If It Is used by. or directly under th#
ann^rvision of. technically quslifisd mo
vtdusKs). The Agency experts Hits require
ntent tc orovlde workers In the developnunt
of a orodoct the same protections as worse"
In Uve laboratory. In addition, section 5(1' <
131 of (he Act sDscificallr provide* that In
order lui a substance to bs esempted from
the rvqulr-iTietile of premaDufartwrv nolir
MUM) all persons handling the chsDu-
•ul "lance for the manufacturer or pros'
eor must be nutlDed of any risk to he* t
Which the msnufacturer. processor nr »!,•¦
Adminiiitrator has reason to bslleve mav
swsoclsied w| tb It.
Comment M; Tlie exemption for 9B*U
quiiitlUsi" should out extend to ohemi
substances distributed In commerce
Reaponse. The Administrator dUm
»lib iIds comment Oongrsw recopnlvved thsi
IfOCKAl ttCIMtf. VOt. 43. NO. J4»—»KI0Ay. 0tCtM«(* J3, 1477
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Final Report of the Small Business Advocacy Review Panel on Toxic Substances Control Act (TSCA)
Section 6(a) Rulemaking for N-Methylpyrrolidone (NMP)
APPEK1 1 • ^ * hk-o >Hnaitted by Small Entity
Representatives following the Pre-Panel ^ N oach
Meetings
Appendix B is a compilation of all written comments submitted by SERs following the Pre-Panel
Outreach meeting on March 28, 2023, contained in a separate attachment. One SER submitted written
comments: ReGen III Corp.
No written comments were received following the Panel Outreach meeting.
B-1
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ReG^n1"
O/Ref: REG-GE0-HS-LTR-0001
April 10, 2023
Ms. Lanelle Wiggins
RFA/SBREFA Team Leader 5
U.S. Environmental Protection Agency
1200 Pennsylvania Ave NW
Washington, D.C. 20460
Re: Response to the Environmental Protection Agency Regarding the Pre-Panel Outreach Meeting
on TSCA6a NMP Rulemaking (March 28, 2023)
Dear Ms. Wiggins,
This letter is regarding the U.S. Environmental Protection Agency (EPA) meeting on TSCA6a NMP
Rulemaking, conducted on March 28, 2023. At this meeting, the EPA raised questions related to NMP and
its use. Please find attached ReGen Ill's written responses to the questions provided in the meeting
material.
ReGen III is a cleantech company, building a green project that is profitable, non-reliant on government
subsidies, and sustainable. ReGen III owns a portfolio of patented technologies that enable used motor
oil (UMO) to be re-refined to produce base oils at a higher value product mix than traditional methods
provide. Not only does recycling of UMO produce high value products, it is also environmentally
responsible because it replaces supply of base oils produced by traditional refining methods, which are
substantially more energy intensive. Re-refining UMO also prevents it from being disposed improperly or
burned as a fuel. The life-cycle assessment study estimates that C02e emissions from the ReGen III
process are 82% lower than comparable, traditionally produced refined base oils that are later used as
fuel at end of life. Furthermore, our proposed facility in Texas is projected to reduce up to 903,000 mt
C02e / year from entering the atmosphere, the equivalent of removing 195,000 passenger vehicles from
the road.
ReGen III is a start-up company that has been developing its process over the last fifteen years. ReGen
III has invested over$50M during those years in research, testing and engineering, and are on the cusp
of proceeding with our first full-size facility that will see over 1 million person-hours in direct construction
labor as well as 40-50 full time jobs during operation.
At the heart of the process is the use of NMP. NMP was chosen and has been tested exclusively over the
last fifteen years primarily because of its selectivity for polars and aromatics, compounds that must be
removed to produce higher quality base oils. Alternative solvents do not provide the required level of
selectivity.
The ReGen III UMO re-refinery is being designed with high standards for health and safety, typical of
refineries. ReGen III will incorporate the following to manage exposure to NMP:
• A closed loop system to limit exposure pathways to NMP
• Incorporation of engineering controls to limit releases
• Development of rigorous operating procedures
• Extensive training for employees/contractors regarding the risks associated with NMP
• Provision of the appropriate PPE
• Placement of warning signs
• Restrictions for at-risk personnel entering the NMP area
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ReGEil
ReGen III is a pre-revenue start-up and the project will be severely impaired, if developed at all, if NMP is
prohibited or if a concentration limit is imposed. ReGen III will manage the NMP exposure with a closed
loop design, engineering controls and operating procedures.
Tom Lawlor, P.Eng
Chief Operating Officer
ReGen III (USGC) Corporation
tlawlor@reaeniii.com
720.201.3815
Attachment
Sincerely,
B-3
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ReGEn'"
ATTACHMENT
Questions raised in NMP Pre-Panel Presentation
1. Discussion - Your Business and NMP
• How does your organization use NMP?
ReGen III is building a facility to recycle used motor oil into Group II/II+ and high-value Group III base oils.
Base oils are the foundation for several types of lubricants such as lubricating greases, motor oils, metal
processing fluids, and miscellaneous lubricants. All lubricants require a base oil and automotive engine
oils typically consist of 75% base oil and 25% additives. The majority of traditional refiners produce Group
I and Group II base oils which are used to formulate motor oils for older passenger car engines or for use
in some industrial applications. Approximately 70% of new cars require fully synthetic or blend oil, which
utilize Group III or higher quality base oil. ReGen Ill's technology produces a 53% yield of Group III base
oil. Group III base oil is the fastest growing group of base oils as more automakers require the use of
better-quality motor oils.
The UMO re-cycling facility is a three-stage process. See Figure 1 for a block flow diagram.
UMO
Secured through
feedstock agreements by
approved collectors
across North America
ReCen Process Differentiator
Contaminant
Separation Unit ("CSU")
Molecular
Separation Unit ("MSU")
Molecular
Treatment Unit ("MTU")
Multi-stage distillation
evaporation to
remove contaminants
and produce VCO
Solvent extraction to
separate high quality base
oil from low quality base oil
Hydro-finishing
treatment of
lower quality base oil
53% Yield
Croup III Base Oil
22% Yield
Group II+ Base Oil
Figure 1. ReGen III Process Block Flow Diagram.
Stage 1 removes lighter hydrocarbons and contaminants such as metals and water. Stage 2 uses solvent
extraction (with NMP) to remove aromatics and polars to produce Group III base oil. Stage 3 hydrotreats
the extract from Stage 2 to produce Group II/II+ base oil.
Stage 2, or the Molecular Separation Unit (MSU), is designed to continually process the product of Stage
1 (vacuum gas oil, VGO). The system begins with the Scheibel® extraction column, which uses agitation
and solvent extraction to purify the oil into two liquid streams, defined as the raffinate and the extract. The
solvent. N-Methvl 2-Pvrrolidinone (NMP), has been selected to extract the low-quality products, aromatics
and polar components.
In the extraction column, the VGO enters at the bottom of the tower while the NMP flows counter currently
from the top of the tower. The extract stream, which contains the majority of the NMP and the lower
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ReG^n1"
quality base oil (polars and aromatics are concentrated in this stream), is distilled under vacuum to and
then further steam stripped to remove the NMP. The low-quality base oil is transferred to the 3rd stage for
hydrotreating. The raffinate stream, having had the undesirable components (polars and aromatics) of the
VGO removed by the NMP, flows to a stripper column and uses steam to remove the residual NMP. The
bottoms product from this stripper is the primary product of the process, Group III base oil.
The NMP, removed from both the raffinate and extract streams, is regenerated in a closed system,
returned to the storage tank where it is circulated back to the extraction column. The NMP circulation rate
is approximately 330 usgpm and the storage tank (designed to API 650), with nitrogen blanketing,
contains approximately 60,000 gallons.
• Can you describe the specific use, as well as the workplace and workplace setting where it is
used?
The specific use is described in the previous answer.
The re-refinery will be constructed on a 10-acre plot in Texas City (Advario Texas City site, located at
2800 Loop 197 S, Texas City, Texas), within an existing industrial site, on land previously occupied by
DOW Chemicals and leased to ReGen III by Advario. In a partnership with Advario, ReGen III will design,
build, own, and operate the re-refinery. Advario will be the Terminal Services Provider, responsible for
receiving, storage and shipping UMO and products via truck, rail and barge, with their facilities split
between their Advario Galveston and Advario Texas City sites.
All re-refinery equipment is installed outside with open ventilation. All areas where NMP is present will be
bunded. All areas that use NMP (Stage 2 exclusively), will have specific safe operating procedures that
include PPE requirements and restrictions for personnel from entering the NMP use area. Signs will be
installed throughout the stage 2 facilities reminding workers of their training regarding risks to NMP
exposure.
The ReGen III Process Safety Management system will include NMP considerations in the Process
Safety Information, while conducting Process Hazards Analysis, in written operating and maintenance
procedures, and as part of the mechanical integrity program.
• What is the trend of NMP use in your organization ?
NMP will remain the solvent of choice for all future facilities as the process technology is dependent on
this solvent for its selectivity for polar and aromatic compounds which must be removed to generate
Group III.
• How important to your business is the function that NMP provides?
NMP was chosen and has been tested exclusively over the last fifteen years primarily because of its
selectivity for polars and aromatics; compounds critical for removal to produce the higher quality base
oils. Alternative solvents do not provide that required level of selectivity.
ReGen III is a pre-revenue start-up and the project will not severely impaired if NMP is prohibited or if
there is a concentration limit imposed. ReGen III will manage the NMP exposure with a closed loop
design, engineering controls and operating procedures.
• Are there potential critical or essential uses?
No.
• Are there uses for which there are no available technically or economically feasible
alternatives?
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ReGEn1
North American Group III production is dominated by virgin crude refining, which is more energy intensive
and less environmentally friendly. The ReGen III patented process has much lower C02e emissions,
being 82% lower than comparable, traditionally refined base oils produced from crude oil and
subsequently combusted at end of life. The ReGen III process saves 3.4 kg C02e emissions per kg of
base oil produced compared to the traditional method of producing base oil from crude oil and burning
UMO as fuel. Furthermore, ReGen Ill's proposed 5,600 bpd Texas facility is estimated to reduce up to
903,000 mt C02e / year from entering the atmosphere by preventing combustion at end-of-life and by
producing base oils more efficiently than the equivalent production from virgin crude oil. This would be the
equivalent of removing 195,000 passenger vehicles from the road for a year according to the EPA.
In addition, the ReGen III process has a much lower ecotoxicity rating at 27.7% less than the ecotoxicity
of traditional methods of producing base oils and combusting UMO and 99.7% less than the ecotoxicity of
traditional methods of producing base oil and disposal of UMO inappropriately at end of life.
2. Discussion - Workplace Exposure
• What is your experience with exposure control and risk reduction?
Engineering controls will be focussed on the closed loop design of the process and ensuring any potential
releases are eliminated by using vapour recovery and spill containment systems. In addition, the
processing equipment that uses NMP will be fully automated.
Administrative controls will be implemented including developing standard operating procedures and
written working instructions for any activity that involves NMP with an aim to separate the worker from
harm by restricting access to the area and ensuring workers are trained and fully aware of the risks.
Personal Protective Equipment (PPE) will be fitted and available for all workers that are required to work
in the area where NMP is present.
Industrial hygiene programs and regular occupational exposure evaluations will be implemented as part
of the worker health and safety protection plan.
• How many employees are exposed to NMP, and for how long (days/years and hours/day)?
Although the Operations and Maintenance Manual is not finalized yet, the expected crew complement is 4
persons per shift with 2 outside operators managing the facility at any one time. It is expected that one
person per shift will be in the Stage 2 area (where NMP is used) for less than 1 hour a day.
Note that the Stage 2 process area contains NMP in a closed loop system with no inhalation or dermal
exposure risks during normal operations.
• What is the concentration of NMP in the product you use?
100%
• What routine worker activities result in worker exposure to NMP and what type of exposure?
Dermal exposure will be negligible given that NMP is contained in closed process equipment and workers
will be required to wear chemical impervious gloves when conducting maintenance on equipment.
There is no routine work that could result in worker exposure to NMP however there may be infrequent
activities where a breakdown in the primary mitigation occurs such as when human error happens, or a
piece of equipment fails. These would be considered non-routine. In the unlikely case of there being
exposure to NMP, PPE would protect the worker.
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ReG^n1"
• What engineering controls are used to minimize exposure to NMP? Are additional controls
feasible?
The NMP is circulated throughout the process system in a closed loop. There will be a vapour recovery,
spill containment and fully automated systems included in the design. There will be signs restricting
access to the area with warning signs reminding workers of their training on NMP exposure risks.
• What administrative controls and training do you use to minimize exposure to NMP?
See above.
• What respiratory and dermal PPE is regularly worn by workers to minimize exposure to NMP?
Given the facility is currently conducting FEL-3 engineering, the details of PPE have not been fully
developed. However, ReGen III will implement best practices, consult the REACH guidance and adhere
to any EPA requirements.
3. Discussion -Users of Products Containing NMP
• What chemicals or processes have you considered as an alternative to using NMP or a
product containing NMP?
The ReGen III technology of recycling used motor oil did not consider alternatives to NMP. All pilot testing
and engineering studies over the last 15 years have been conducted exclusively on NMP due it its
selectivity for polar and aromatic compounds which must be removed to produce Group III base oil.
However, there are a couple of different solvents used in upgrading crude oil to base oil that could be
used in a solvent extraction process.
• Furfural
• Phenol (hydroxy benzene)
Furfural is less effective than NMP at extracting polar and aromatic compounds with a yield of base oil of
20 to 35% less than with NMP. In addition, the base oil produced with furfural does not meet the viscosity
index specification for Group III base oil. Furfural also forms an azeotrope with water making regeneration
of the solvent very difficult.
Phenols are less effective at extracting polar and aromatic compounds compared to both NMP and
Furfural.
NMP has a lower flammability, lower volatility and greater thermal stability than both furfural and phenol.
NMP is also less toxic than phenol.
• Do you currently use any alternatives to NMP or products containing NMP?
No
• Did you try to switch to another chemical, process, or product, only to switch back? If so,
what did you switch to, why did you switch back, and what made you switch in the first place?
No
• Are there any restrictions or other limitations that prescribe the use of NMP to perform your
services (e.g., for aerospace or DOD customers)?
No
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ReGEn1
• What are the relative advantages and disadvantages of different substitutes and/or processes
that you have considered, including in terms of exposure, cost, and hazard?
N/A
4. Discussion - Regulatory Options
• What regulatory approach should EPA take?
It is ReGenlll's opinion that there is no need for additional requirements from the EPA. Health and safety
practices should be enforced as part of the typical health and safety protocols at a refinery. Site specific
operating protocols will exist within the broader framework of the hazard management and safety
programs. No restrictions on volume or concentration should be placed.
The project will be in serious jeopardy if NMP is prohibited or if there is a concentration limit imposed.
• Are there concerns about the ability to comply with any of the potential regulatory options?
The Project will face severe challenges if NMP is prohibited or if there is a concentration limit imposed.
• What advice do you have for reducing impacts on small businesses?
ReGen III advises that the EPA should limit its rule on NMP to engineering and administrative controls.
• What timeframe would your business need to comply with potential new regulations or
restrictions?
It is difficult for ReGen to assess the impact of any new restrictions. We are confident that we can quickly
adopt PPE, administrative or engineering control requirements. A reduction of NMP concentration or its
prohibition would set the company back 5-10 years.
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