[Federal Register Volume 84, Number 59 (Wednesday, March 27, 2019)]
[Rules and Regulations]
[Pages 11420-11436]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-05666]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 751
[EPA-HQ-OPPT-2016-0231; FRL-9989-29]
RIN 2070-AK07
Methylene Chloride; Regulation of Paint and Coating Removal for
Consumer Use Under TSCA Section 6(a)
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: Methylene chloride, also called dichloromethane, is a volatile
chemical used in paint and coating removal products. In this final
rule, EPA has determined that the use of methylene chloride in consumer
paint and coating removal presents an unreasonable risk of injury to
health due to acute human lethality. In order to address the
unreasonable risk, EPA is prohibiting the manufacture (including
import), processing, and distribution in commerce of methylene chloride
for consumer paint and coating removal, including distribution to and
by retailers; requiring manufacturers (including importers),
processors, and distributors, except for retailers, of methylene
chloride for any use to provide downstream notification of these
prohibitions; and requiring recordkeeping. While EPA proposed a
determination of unreasonable risk from the use of methylene chloride
in commercial paint and coating removal, EPA is not finalizing that
determination in this rule. EPA is soliciting comment, through an
advance notice of proposed rulemaking (ANPRM) published elsewhere in
this issue of the Federal Register, on questions related to a potential
training, certification, and limited access program as an option for
risk management for all of the commercial uses of methylene chloride in
paint and coating removal.
DATES: This final rule is effective May 28, 2019.
ADDRESSES: The docket for this action, identified by docket
identification (ID) number EPA-HQ-OPPT-2016-0231, is available at
http://www.regulations.gov. A public version of the docket is available
for inspection and copying between 8:30 a.m. and 4:30 p.m., Monday
through Friday, excluding Federal holidays, at the U.S. Environmental
Protection Agency, EPA Docket Center Reading Room, WJC West Building,
Room 3334, 1301 Constitution Avenue NW, Washington, DC 20004. A
reasonable fee may be charged for copying.
FOR FURTHER INFORMATION CONTACT:
For technical information contact: Joel Wolf, Chemical Control
Division, Office of Pollution Prevention and Toxics, Environmental
Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-
0001; telephone number: (202) 564-0432; email address:
[email protected].
For general information contact: The TSCA-Hotline, ABVI-Goodwill,
422 South Clinton Ave., Rochester, NY 14620; telephone number: (202)
554-1404; email address: [email protected].
SUPPLEMENTARY INFORMATION:
I. Executive Summary
A. Does this action apply to me?
You may potentially be affected by this final action if you
manufacture (including import), process, or distribute in commerce
methylene chloride (CASRN 75-09-2). The following list of North
American Industrial Classification System (NAICS) codes is not intended
to be exhaustive, but rather provides a guide to help readers determine
whether this document applies to them. Potentially affected entities
may include:
Chemical and Allied Products Manufacturers (NAICS code 32411)
Chemical and Allied Products and Merchants Wholesalers (NAICS
code 4246)
Building Materials and Supplies Dealers (NAICS code 4441)
This action may also affect certain entities through pre-existing
import certification and export notification rules under TSCA. Persons
who import
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any chemical substance governed by a final TSCA section 6 rule are
subject to the TSCA section 13 (15 U.S.C. 2612) import certification
requirements and the corresponding regulations at 19 CFR 12.118 through
12.127; see also 19 CFR 127.28. Those persons must certify that a
shipment of the chemical substance (in this case, methylene chloride)
complies with all applicable rules and orders under TSCA. The EPA
policy in support of import certification appears at 40 CFR part 707,
subpart B. In addition, any persons who export or intend to export a
chemical substance subject to regulation under section 6 (in this case,
methylene chloride) are subject to the export notification provisions
of TSCA section 12(b) (15 U.S.C. 2611(b)), and must comply with the
export notification requirements in 40 CFR part 707, subpart D.
If you have any questions regarding the applicability of this final
action to a particular entity, consult the technical information
contact listed under FOR FURTHER INFORMATION CONTACT.
B. What is the Agency's authority for taking this action?
Under TSCA section 6(a) (15 U.S.C. 2605(a)), if EPA determines that
a chemical substance presents an unreasonable risk of injury to health
or the environment, without consideration of costs or other non-risk
factors, including an unreasonable risk to a potentially exposed or
susceptible subpopulation identified as relevant, under the conditions
of use, EPA must by rule apply one or more requirements to the extent
necessary so that the chemical substance or mixture no longer presents
such risk.
With respect to a chemical substance listed in the 2014 update to
the TSCA Work Plan for Chemical Assessments for which a completed risk
assessment was published prior to the date of enactment of the Frank R.
Lautenberg Chemical Safety for the 21st Century Act, TSCA section
26(l)(4) (15 U.S.C. 2625(l)(4)) provides that EPA ``may publish
proposed and final rules under [TSCA section 6(a)] that are consistent
with the scope of the completed risk assessment and consistent with
other applicable requirements of [TSCA section 6].'' Methylene chloride
is such a chemical substance. It is listed in the 2014 update to the
TSCA Work Plan and the 2014 final risk assessment includes consumer
uses of paint and coating removal, among other uses (Refs. 1 and 2).
EPA is publishing this final rule under TSCA section 6(a) in accordance
with that discretionary statutory authority.
C. What action is the Agency taking?
EPA is making a final determination that the use of methylene
chloride in consumer paint and coating removal presents an unreasonable
risk of injury to health due to acute human lethality. Accordingly, EPA
is issuing a final rule under section 6(a) of TSCA to prohibit the
manufacture (including import), processing, and distribution in
commerce of methylene chloride for consumer paint and coating removal
(including distribution to and by retailers). This final rule also
requires manufacturers (including importers), processors, and
distributors, except for retailers, of methylene chloride for any use
to provide downstream notification of the prohibitions throughout the
supply chain; and requires limited recordkeeping. More details on these
requirements are in Unit III.B.
In the proposed rule for methylene chloride in paint and coating
removal (Ref. 3), EPA proposed an unreasonable risk determination for
methylene chloride in commercial paint removal uses. In addition, EPA
proposed to regulate under TSCA section 6(a) manufacture (including
import), processing, distribution in commerce and use of methylene
chloride in paint and coating removal for certain commercial uses. As
noted previously, exercising its discretion under section 26(l)(4), EPA
is not finalizing the proposed unreasonable risk determination and the
proposed regulation for commercial uses of methylene chloride in paint
and coating removal in this final action. Rather, EPA is soliciting
comment, through an ANPRM published elsewhere in this issue of the
Federal Register, on questions related to a potential training,
certification, and limited access program as an option for risk
management for all of the commercial uses of methylene chloride in
paint and coating removal. More details on the proposed rule are in
Unit II.B.2.
In the proposed rule for methylene chloride in paint and coating
removal, EPA also proposed to regulate under TSCA section 6(a) N-
methylpyrrolidone (NMP) in paint and coating removal. EPA is not
finalizing the proposed regulation for NMP as part of this action. NMP
use in paint and coating removal will be incorporated into the risk
evaluation currently being conducted under TSCA section 6(b). More
information about the proposed rule and NMP is in Unit II.B.2.
D. Why is the Agency taking this action?
Based on EPA's analysis of consumer exposures to methylene chloride
in paint and coating removal, EPA is making a final determination that
the use of methylene chloride in consumer paint and coating removal
presents an unreasonable risk of injury to health due to acute human
lethality. This final rule addresses the unreasonable risk, which may
include death due to asphyxiation, in a manner that results in the
chemical no longer presenting that unreasonable risk. Effects from
acute exposure during use of methylene chloride in paint and coating
removal may include neurological impacts such as dizziness,
incapacitation, loss of consciousness, coma, and death (Ref. 2).
As noted in Unit III.A., EPA is regulating certain conditions of
use of methylene chloride related to consumer paint and coating
removal, which is estimated to comprise less than 10% of the total use
of the chemical (Ref. 4).
E. What are the estimated impacts of this action?
As described in more detail in the Economic Analysis (Ref. 4),
EPA's analysis of the cost of this rule is estimated to be $3.8 to
$13.6 million annualized over 20 years at a 3% discount rate and $3.8
to $13.7 million annualized over 20 years at a 7% discount rate.
Because the costs estimated in this rule are variable, the values at
the different discount rates are similar. Unquantified costs include
potential loss of producer and consumer surplus associated with
possible reductions in paint and coating removal activity. There may
also be unquantified costs associated with performance of alternatives
including longer time for products to work and countervailing hazards
from alternative chemicals including potentially higher flammability
and exposure to other toxic chemicals.
Preventing exposure to methylene chloride in consumer paint and
coating removal results in monetized benefits, as well as non-monetized
benefits. Monetized benefits include the prevention of deaths resulting
from acute adverse effects that occur at a known rate among consumer
users. Non-monetized benefits result from the prevention of some non-
cancer adverse effects to the nervous system. Thus, there is not a
quantification or monetary valuation estimate for the overall total
benefits. Based on the benefits that EPA can monetize, the benefits for
this rule are approximately $3.5 million per year over 20 years at 3%
and 7% discount rate (Ref. 4).
F. Children's Environmental Health
This action is consistent with the 1995 EPA Policy on Evaluating
Health
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Risks to Children (http://www.epa.gov/children/epas-policy-evaluating-risk-children). In its TSCA Work Plan Risk Assessment for methylene
chloride, EPA identified risks from inhalation exposure to children who
may be present as bystanders in homes where consumer paint and coating
removal occurs. These risks may include neurological effects such as
cognitive impairment, sensory impairment, dizziness, incapacitation,
and loss of consciousness (leading to risks of falls, concussion, and
other injuries). Supporting information on the health effects of
methylene chloride exposure to children is available in the
Toxicological Review of Methylene Chloride (Ref. 5) and the Final Risk
Assessment on Methylene Chloride (Ref. 2), as well as Unit II.A.
II. Background
A. Methylene Chloride, Health Effects, Risks, and Other Regulatory
Actions
Methylene chloride (CASRN 75-09-2) is a solvent used in a variety
of industrial, commercial and consumer use applications, including
adhesives, pharmaceuticals, metal cleaning, chemical processing, and
feedstock in the production of refrigerant hydrofluorocarbon-32 (Ref.
2). According to the 2016 Chemical Data Reporting (CDR) information,
approximately 264 million pounds of methylene chloride were
domestically manufactured or imported into the United States in 2015,
with the bulk of the volume domestically manufactured (Ref. 6). Most
methylene chloride is produced and used for purposes other than paint
and coating removal, which represents less than 10% of total use of
methylene chloride (Ref. 4). In terms of environmental releases, 271
facilities reported a total of 3.4 million pounds of releases of
methylene chloride to the 2015 Toxics Release Inventory (Ref. 7).
Individuals are exposed to methylene chloride from industrial/
commercial and consumer sources in different settings, such as homes
and workplaces, and through multiple routes (inhalation, dermal, and
ingestion).
Methylene chloride is acutely lethal, a neurotoxicant, and a likely
human carcinogen. This final rule is specifically intended to prevent
the unreasonable risks of injury to health due to acute human lethality
from use of methylene chloride for consumer paint and coating removal.
The risk assessment presents a detailed description of the range of
adverse acute and chronic health effects associated with methylene
chloride (Ref. 2).
The primary target organ of methylene chloride acute toxicity is
the brain, and neurological effects result from either direct narcosis
or the formation of carbon monoxide. The accumulation of
carboxyhemoglobin in the blood can lead to sensory impairment,
dizziness, incapacitation, loss of consciousness, heart failure, and
death. The neurotoxic and cardiovascular effects may be exacerbated in
fetuses and in infants with higher residual levels of fetal hemoglobin
when exposed to high concentrations of methylene chloride (Ref. 2).
Based on data from the Occupational Safety and Health
Administration (OSHA), the Consumer Product Safety Commission (CPSC),
state records, and publicly reported information, EPA identified 49
fatalities from 1976 to 2016 (Ref. 3 at p. 7482) resulting from
consumer or commercial worker exposure to methylene chloride during
paint and coating removal. However, this may be an underestimate of the
deaths that have occurred (Refs. 7 and 8). More details are provided in
the proposed rule (Ref. 3 at p. 7468).
Since the publication of the January 19, 2017, proposed rule, EPA
has learned of four additional fatalities due to methylene chloride in
paint and coating removal (Ref. 10). Two of the victims were
independent contractors working for small or family-owned businesses,
the third was a small business owner, and the fourth was a consumer who
died while using a methylene chloride paint and coating removal product
to remove paint (Ref. 10). Many of the victims used paint and coating
removers easily available to consumers through retailers. This may not
constitute an exhaustive list of fatalities, rather, those that were
brought to the attention of the Agency since publication of the
proposed rule.
The use of methylene chloride in paint and coating removal presents
an increased risk of death and nervous system effects for many of the
estimated 1.3 million consumers and residential bystanders who use or
are exposed to methylene chloride through consumer paint and coating
removal each year (Ref. 4). Of particular concern is the potential for
acute neurological impairment (central nervous system depressant
effects) for consumers using methylene chloride for paint and coating
removal. In the risk assessment, the upper-end scenarios for consumer
users had 4-hour exposures of 233 parts per million (ppm). As described
in the risk assessment, the Acute Exposure Guideline (AEGL-2), which is
the threshold for disability for an 8-hour exposure, is 60 ppm. In
humans, acute exposure to methylene chloride above 200 ppm results in
acute neurobehavioral deficits measured in psychomotor tasks including:
Tests of hand-eye coordination, visual evoked response changes, and
auditory vigilance. In a few cases, cardiotoxic effects (i.e.,
evidenced by electrocardiogram changes) were reported in humans (Ref.
2).
Some populations are currently at disproportionate risk for the
health effects associated with use of methylene chloride in paint and
coating removal, including children present in homes where consumer
paint and coating removal is conducted. EPA's full analysis, conducted
as part of compliance with Executive Order 13166 (65 FR 50121, August
11, 2000) and Executive Order 12898 (59 FR 7629, February 16, 1994) is
described in the proposed rule (Ref. 3 at pp. 7476, 7525).
While the primary concern has been human health, there is potential
for methylene chloride exposures to adversely impact ecological
receptors. Methylene chloride is mainly released to the environment in
air, and to a lesser extent in water and soil, due to industrial/
commercial and consumer uses as a solvent, in aerosol products, and in
paint and coating removal. Methylene chloride is moderately persistent
and its bioaccumulation potential is low. Though volatile, methylene
chloride has negligible atmospheric photochemical reactions, and is
therefore exempt from being classified as a volatile organic compound
(VOC) as defined at 40 CFR 51.100(c).
The proposed rule presented a comprehensive overview of regulatory
actions by EPA, other Federal agencies, and state and international
agencies pertaining to methylene chloride use in paint and coating
removal and actions addressing methylene chloride waste disposal,
releases to air and contamination of groundwater, drinking water, and
soils (Ref. 3 at p. 7469). EPA presents here a summary of those
actions, with a focus on those that have changed since the proposed
rule.
EPA has issued several final rules and notices pertaining to
methylene chloride under EPA's various authorities. Under the Clean Air
Act, which designates methylene chloride as a hazardous air pollutant
(HAP), EPA has promulgated several National Emissions Standards for
Hazardous Air Pollutants (NESHAPs) addressing specific sources for
methylene chloride emissions, including area sources engaged in paint
stripping, surface coating of motor vehicles and mobile equipment, and
miscellaneous surface coating
[[Page 11423]]
operations, and a 2015 update to a 1995 NESHAP for Aerospace
Manufacturing and Rework Facilities (42 U.S.C. 7412(b)(1)) CAA).
Methylene chloride is listed as a hazardous waste under the Resource
Conservation and Recovery Act (RCRA) (Hazardous Waste No. U080, for
discarded commercial products, and Waste Nos. F001, F002, for spent
halogenated solvents including those halogenated solvents used in
degreasing) and as a hazardous constituent in appendix VIII to 40 CFR
part 261 (Ref. 2). The Emergency Planning and Community Right-to-Know
Act, section 313, lists methylene chloride on the Toxics Release
Inventory (TRI) (Ref. 2). The Safe Drinking Water Act requires EPA to
determine the level of contaminants in drinking water at which no
adverse health effects are likely to occur, with EPA setting a maximum
contaminant level goal of zero and an enforceable maximum contaminant
level for methylene chloride (dichloromethane) at 0.005 milligrams/
Liter (mg/L) or 5 parts per billion (ppb) (57 FR 31776, July 17, 1992).
Other Federal agencies with regulations on methylene chloride
include the Food and Drug Administration (FDA), which has banned
methylene chloride as an ingredient in all cosmetic products (21 CFR
700.19); OSHA, which has a permissible exposure limit (PEL) of 25 ppm
as an eight-hour time-weighted average (TWA) and a 15-minute short-term
exposure limit (STEL) of 125 ppm; and CPSC, which has updated its
labeling policy for household products containing methylene chloride.
In 2016, CPSC was petitioned by the Halogenated Solvents Industry
Alliance to amend its guidance contained in the Statement of
Interpretation and Enforcement Policy on the Labeling of Certain
Household Products Containing Methylene Chloride; CPSC published that
petition and requested public comments (81 FR 60298, September 1,
2016). In response to that petition, CPSC updated the cautionary
labeling policy for paint strippers containing methylene chloride to
recommend the inclusion of language on the principal display panel of
the label and on the back or other panel to specifically describe the
risk of fatality from acute exposure in enclosed spaces (83 FR 12254,
March 21, 2018; 83 FR 18219, April 26, 2018). CPSC's recommendations
also included providing specific examples of spaces in which the
product should not be used, incorporating precautionary information for
indoor use, and warning against foreseeable inappropriate actions that
are not sufficiently protective, such as use of a dust mask to provide
protection against vapors. More information on CPSC's updates are in
Unit III.A.4.
Several states have taken actions to reduce or make the public
aware of risks from methylene chloride. In November 2017, California
EPA's Department of Toxic Substances Control (DTSC) proposed to list
paint strippers with methylene chloride as a priority product under its
Safer Consumer Products regulations (Ref. 11). Methylene chloride is on
DTSC's list of candidate chemicals (Ref. 12). If finalized,
California's regulation on methylene chloride in paint and coating
removers would trigger notification requirements for responsible
entities, such as manufacturers and importers to DTSC, and require
those companies making paint strippers with methylene chloride to
analyze alternatives to determine if methylene chloride is essential
and whether there are available alternatives.
B. History of This Rulemaking
This rule finalizes certain parts of the regulation proposed on
January 19, 2017 (Ref. 3) with respect to methylene chloride use for
consumer paint and coating removal. The proposed rule followed EPA's
2014 final risk assessment of methylene chloride for paint and coating
removal. The changes in this final rule from the proposal are discussed
in Unit III.
1. TSCA Work Plan and Methylene Chloride Risk Assessment. In 2012,
EPA released the initial list of TSCA Work Plan chemicals identified
for further assessment under TSCA as part of its chemical safety
program (Ref. 1). The process for identifying these chemicals was based
on a combination of hazard, exposure, and persistence and
bioaccumulation characteristics, and is described in the ``TSCA Work
Plan Chemicals: Methods Document'' (Ref. 13). Under the TSCA Work Plan
chemical criteria, methylene chloride ranked high for health hazards
and exposure potential. Methylene chloride also appeared in the 2014
update of the TSCA Work Plan for Chemical Assessments.
EPA finalized a TSCA Work Plan Chemical Risk Assessment for
methylene chloride in paint and coating removal (methylene chloride
risk assessment) in August 2014, following the 2013 peer review of the
2012 draft methylene chloride risk assessment. The completed 2014 risk
assessment and all documents from the peer review process are available
in Docket Number EPA-HQ-OPPT-2012-0725.
The 2014 methylene chloride risk assessment evaluated health risks
to consumers, among others, from inhalation exposures from methylene
chloride use in paint and coating removal. A more detailed discussion
of the risk assessment is included in the proposed rule (Ref. 3 at p.
7470). The risk assessment identified risks of concern following acute
(short-term) exposures for consumers and others conducting paint
removal with methylene chloride, as well as for exposed bystanders,
including residents of homes in which paint removal is conducted. The
acute risks identified include death; neurological impacts such as
dizziness, incapacitation, loss of consciousness, and coma (Ref. 2).
The assessment identified risks from acute exposures to methylene
chloride when used for consumer paint and coating removal, including
(Ref. 2):
Acute risks of neurological effects for consumer users of
methylene chloride as a paint remover.
Acute risks of neurological effects for bystanders
(including children) in the location in which paint removers containing
methylene chloride are used by residents (i.e. consumer paint and
coating removal). These risks are also present for exposures to
methylene chloride in a location after the paint removal work is
complete, because methylene chloride can remain in the air in spaces
that are enclosed, confined, or lacking ventilation.
Among the comments on the proposed rule, an overview of which is
given in Unit II.B.3., EPA received 28 comments related to the 2014
risk assessment. Twelve mass-mailing campaigns, resulting in over
100,000 public comments, and four individual comments reiterated or
supported the conclusions of the risk assessment. A separate individual
comment provided a list of additional references documenting the health
effects and deaths from methylene chloride use. Other commenters
identified what they believe were shortcomings in the risk assessment,
such as an underestimation of risk; lack of proper consideration of
available data; deficiencies in risk estimation; an overestimation of
risk; and lack of verification of data and fatality incident reports.
Other comments included additional information from local governments
regarding fatalities and adverse effects from use of methylene chloride
in paint removers. There were also comments related to carcinogenicity.
The Small Business Advocacy Review (SBAR) Panel convened in support
of this action heard from several Small Entity Representatives (SERs)
who expressed concerns about the underlying methylene chloride risk
assessment (Ref. 14). Many of the
[[Page 11424]]
concerns expressed by these SERs were already expressed in the public
comments and the peer review comments on the methylene chloride risk
assessment. The Summary of External Peer Review and Public Comments and
Disposition document in the risk assessment docket (EPA-HQ-OPPT-2012-
0725) explains how EPA responded to the comments received.
EPA appreciates the comments supporting the conclusions of the risk
assessment and those providing additional information. Some commenters
expressed concern about analytical shortcomings in the risk assessment.
However, the risk assessment relied on previous assessments that used
current hazard and risk assessment methodology documented in EPA
guidance. In particular, the hazard and dose response information in
the risk assessment were developed by reputable organizations and
subject to peer review processes and the cancer descriptor ``likely
carcinogenic in humans'' is based on EPA's Toxicological Review using a
weight of evidence approach (Ref. 5). The methylene chloride risk
assessment was also peer reviewed. The comments on the risk assessment
that were received during the comment periods on the proposed rule, and
EPA's responses, are in the Response to Comments document (Ref. 15).
2. EPA's proposed rule under TSCA Section 6(a) for methylene
chloride. EPA proposed to prohibit the manufacture (including import),
processing, and distribution in commerce of methylene chloride for all
consumer and most types of commercial paint removal, and to prohibit
most commercial use of methylene chloride for paint and coating
removal. Exercising its discretion under section 26(l)(4), EPA is not
finalizing the portion of the proposal relating to commercial paint and
coating removal today. EPA will address commercial paint and coating
removal in the future after soliciting comment, through an ANPRM
published elsewhere in this issue of the Federal Register, on questions
related to a potential training, certification, and limited access
program.
EPA proposed a determination of unreasonable risk from the use of
NMP in paint and coating removal. However, exercising its discretion
under section 26(l)(4), EPA is not finalizing the proposed unreasonable
risk determination for NMP in paint and coating removal at this time.
EPA intends to incorporate NMP use in paint and coating removal in the
risk evaluation for NMP. EPA has concluded that the Agency's assessment
of the potential risks from this widely used chemical will be more
robust if the potential risks from these conditions of use are
evaluated by applying standards and guidance under amended TSCA. In
particular, this includes ensuring the evaluation is consistent with
the scientific standards in Section 26 of TSCA, including using best
available science and systematic review approaches. Additional
information on the NMP risk evaluation process, including public
meetings, supporting documents, and public comments, is available in
Docket Number EPA-HQ-OPPT-2016-0743.
In the proposed rule, EPA described supplemental analyses used to
inform certain aspects of risk management for methylene chloride in
paint and coating removal (Ref. 3 at p. 7472). These analyses were
consistent with the scope of the methylene chloride risk assessment and
were based on the peer-reviewed methodology used in the risk assessment
(Ref. 3 at p. 7521). While EPA stated in the proposed rule that these
analyses would be peer reviewed prior to promulgation of a final rule
and received one comment on the proposed rule to that effect, they will
not be peer reviewed at this time because EPA is not finalizing
regulatory approaches informed by the results of those analyses.
In the proposed rule for methylene chloride in paint and coating
removal (Ref. 3), EPA proposed an unreasonable risk determination for
commercial uses of methylene chloride in paint and coating removal,
including commercial furniture refinishing. EPA, in collaboration with
the Small Business Administration's Office of Advocacy, conducted a
workshop on furniture refinishing in Boston, MA on September 12, 2017
(82 FR 41256, August 30, 2017) (FRL-9966-83). A transcript of the
meeting and speaker presentations are available in Docket Number EPA-
HQ-OPPT-2017-0139.
In the proposed rule, EPA requested comment on a process for
receiving and evaluating petitions requesting EPA to promulgate
statutory exemptions. While EPA is not finalizing an exemption process
in this rule, EPA will take the commenters' suggestions into account as
EPA considers how to proceed in the future with respect to exemptions
under TSCA section 6(g).
3. Public comments and other public input. The proposed rule
provided for a 90-day comment period, ending on April 19, 2017; this
comment period was extended until May 19, 2017, in response to public
requests (82 FR 20310, May 1, 2017) (FRL-9961-66). Even though EPA
received requests for a lengthier extension of the comment periods, the
Agency concluded that a 30-day extension of the initial comment period
was sufficient.
EPA received more than 147,000 comments on the proposed rule.
Commenters included private citizens, potentially affected businesses,
trade associations, environmental and public health advocacy groups,
state and local governments, and other Federal agencies. Most of the
comments received through mass mail campaigns and individual public
comments supported the rule and urged EPA to prohibit the use of
methylene chloride in paint and coating removal to stop putting
families, workers and communities at risk, citing the lethality of
methylene chloride and fatalities due to paint and coating removal with
methylene chloride. Other commenters opposed the rule, and questioned
EPA's authority for issuing it. In this preamble, EPA has responded to
many of the comments relevant to methylene chloride in consumer paint
and coating removal; however, the more comprehensive version of EPA's
response to comments related to this final action can be found in the
Response to Comments document (Ref. 15). Public interest in the
proposed rule extended beyond the comments received on the proposal and
at a furniture refinishing workshop described earlier. EPA continued
discussions with the public to receive clarification on comments
received on the proposed rule. This included meetings requested by W.
M. Barr, Breast Cancer Prevention Partners, Natural Resources Defense
Council, and Safer Chemicals Healthy Families, to discuss their
comments and by families who have lost relatives using methylene
chloride in paint removal (Refs. 16, 17, 18 and 19). EPA staff also
attended a demonstration hosted by W. M. Barr of various paint and
coating removal products (Ref. 20). EPA also consulted with state
officials to discuss methylene chloride deaths reported since the
proposal. (Ref. 21 and. Ref. 15).
4. Risk evaluation of methylene chloride. EPA announced in December
2016 its designation of methylene chloride as one of the ten chemical
substances that will undergo risk evaluation pursuant to section
6(b)(2)(A) of TSCA (81 FR 91927, December 19, 2016) (FRL-9956-47). The
purpose of the risk evaluation under section 6(b)(4)(A) is to determine
whether methylene chloride presents an unreasonable risk of injury to
health or the environment under the conditions of use. The scope of the
methylene
[[Page 11425]]
chloride risk evaluation identifies, among other issues, the conditions
of use, including manufacturing, processing, and other uses beyond
paint removal, such as adhesives and degreasing. If EPA makes a
determination of unreasonable risk in the final risk evaluation for any
of the other methylene chloride conditions of use included in that risk
evaluation, EPA will subsequently issue a section 6(a) rule applying
risk management requirements to the extent necessary so that such
unreasonable risk is no longer present.
With respect to this final rule for methylene chloride in consumer
paint and coating removal, although some commenters questioned EPA's
authority to issue a final rule on methylene chloride in paint and
coating removal without finalizing the peer review of the supplemental
analysis and other commenters urged EPA to use its discretion not to
finalize the rule and instead re-evaluate the paint and coating removal
use under the risk evaluation under section 6(b)(4)(A), the Agency is
exercising its discretion to proceed with this final rule addressing
unreasonable risk from methylene chloride in consumer paint and coating
removal in accordance with TSCA section 26(l)(4). TSCA section 26(l)(4)
(15 U.S.C. 2625(l)(4)) provides that, for a chemical substance listed
in the 2014 update to the TSCA Work Plan for Chemical Assessments for
which a completed risk assessment was published prior to the date of
enactment of the Frank R. Lautenberg Chemical Safety for the 21st
Century Act, EPA ``may publish proposed and final rules'' under TSCA
section 6(a) that are consistent with the scope of the completed risk
assessment and with other applicable requirements of TSCA section 6.
Methylene chloride was listed in the 2014 update to the TSCA Work Plan
and the completed risk assessment was published in 2014. EPA is
publishing this final rule under TSCA section 6(a) in accordance with
that discretionary authority.
EPA is conducting a risk evaluation of the other conditions of use
of methylene chloride under TSCA section 6(b). Additional information
regarding the risk evaluation for the other conditions of use of
methylene chloride, including public meetings, supporting documents,
and public comments, is available in Docket Number EPA-HQ-OPPT-2016-
0742.
III. Provisions of This Final Rule
EPA carefully considered all the public comments related to
consumer paint and coating removal, as well as other information
reasonably available in order to develop this final rule. As indicated
previously, in this final action EPA is only addressing methylene
chloride in consumer paint and coating removal and will address
methylene chloride in commercial paint and coating removal in the
future after soliciting comment, through an ANPRM published elsewhere
in this issue of the Federal Register, on questions related to a
potential training, certification, and limited access program. The
changes from the proposed action to this final action related to
methylene chloride in consumer paint and coating removal are:
Further clarification in the final rule that paint and
coating removers containing methylene chloride cannot be distributed to
or by retailers and clarification that a retailer includes a person
that distributes in commerce or makes available a chemical substance,
mixture or article to consumers, including via internet sales or
distribution. Any distributor with at least one consumer client is
considered a retailer;
A decision not to finalize the proposal's requirement for
the distribution in commerce of methylene chloride for paint and
coating removal in containers with a volume of less than 55 gallons.
This requirement would have imposed an additional mitigation measure to
address the risks to consumers from methylene chloride in consumer
paint and coating removal. However, in this final rule, by eliminating
access to methylene chloride for consumer paint and coating removal,
via the retailer distribution restrictions, the unreasonable risk from
consumer paint and coating removal use is addressed:
A change in the date that the requirements begin for
recordkeeping and for downstream notification of the prohibitions in
this rule, from 45 days to 90 days after the effective date of the
rule;
Clarification that the downstream notification requirement
should be done through the safety data sheets (SDSs) and provision of
language required in the SDSs; and
A provision allowing required records to be kept either at
a company's headquarters or at the facility for which the records were
generated.
In addition, this action finalizes the general provisions related
to definitions, exports and imports requirements, and enforcement and
inspections. These provisions were originally presented in another
proposed rule, entitled ``Trichloroethylene; Regulation of Certain Uses
Under TSCA section 6(a)'' (Ref. 23). As EPA is newly establishing 40
CFR part 751 to address the regulation of certain chemical substances
and mixtures under TSCA section 6, the Agency intended that the general
provisions presented in Subpart A of the proposed rule on
trichloroethylene apply to all TSCA section 6 chemical substance
regulations presented in part 751 (Ref. 23 at p. 91623). EPA's proposed
rule on methylene chloride and NMP use in paint and coating removal
specifically proposed to build upon the proposed part 751 presented
therein, stating that the ``proposal relies on general provisions in
the proposed part 751, subpart A, which can be found at 81 FR 91592
(December 16, 2016)'' (Ref. 3 at p. 7519), and that ``40 CFR part 751,
as proposed to be added at 81 FR 91592 (December 16, 2016), is proposed
to be further amended'' by adding proposed regulatory provisions
addressing paint and coating removal uses of methylene chloride and NMP
in subparts B and C, respectively (Ref. 3 at p. 7529). Since the
trichloroethylene rule has not been finalized, the proposed general
provisions are included in this final action with two modifications:
1. Further elaboration of TSCA section 6(a) requirements; and
2. A minor modification to clarify that inspections will be
conducted at EPA discretion in accordance with TSCA section 11 and are
not required under that authority.
A. Scope and Applicability
In this final action, EPA is regulating the manufacture (including
import), processing and distribution in commerce of methylene chloride
for consumer paint and coating removal, including distribution of
methylene chloride for consumer paint and coating removal to and by
retailers. The details of the prohibitions and requirements of this
final rule are in Unit III.B.
1. Paint and coating removal products. Methylene chloride has been
used for decades in paint and coating removal in products intended for
both consumer and commercial uses. Paint and coating removal, also
referred to as paint stripping, is the process of removing paint or
other coatings from a surface. Coatings can include paint, varnish,
lacquer, graffiti, polyurethane, or other high-performance or specialty
coatings. Surfaces or substrates may be the interior or exterior of
buildings, structures, vehicles, aircraft, marine craft, furniture, or
other objects and include a variety of materials, such as wood, metals,
plastics, concrete, and fiberglass. Paint and coating removal can be
conducted in consumer or occupational settings (Ref. 2).
[[Page 11426]]
Paint and coatings can be removed by chemical, mechanical, or
thermal means. Chemical paint removers can include solvents, such as
methylene chloride, or caustic chemicals. Solvents permeate the top of
the coating and dissolve the bond between the coating and the substrate
(Ref. 22). Following the application of the chemical paint remover, the
coating can be more easily peeled, scraped, or mechanically removed
from the substrate. Techniques for applying the paint remover chemical
include manual coating or brushing, tank dipping, flow-over systems,
spray applications (manually or through automation), pouring, and
wiping and rolling (manual or automated) (Ref. 2). Methylene chloride
has been used to remove paint and coatings from walls, trim, furniture,
architectural features, patios or decks, ceilings, bathtubs, floors,
civilian aircraft, marine craft, cars, trucks, railcars, tankers,
storage vessels, and other vehicles or their component parts to prepare
for new coatings. Methylene chloride is typically applied to the
surface using a hand-held brush, then left on to soften the old
coating, and once curing has occurred, the old coating is scraped or
brushed off to clean the surface. For bathtub refinishing, methylene
chloride is poured and brushed onto a bathtub using a paintbrush and
then scraped from the bathtub after leaving the remover to cure for 20
to 30 minutes (Ref. 4). Consumer use of methylene chloride in paint and
coating removal occurs in consumer settings, such as homes, workshops,
basements, garages, attics, and outdoors. More information on specific
paint removal techniques is in the methylene chloride risk assessment
(Ref. 2).
Though some users are switching to substitutes and alternative
methods, methylene chloride use continues because it is readily
available and works quickly and effectively on nearly all coatings
without damaging most substrates. In addition, some users prefer
methylene chloride because it is less flammable than some other
solvents; however, paint and coating removal products formulated with
methylene chloride tend to contain high concentrations of co-solvents
that are flammable (Ref. 24). Also, methylene chloride is extremely
volatile, has strong fumes, and evaporates quickly so that it must be
reapplied for each layer of paint or coating to be removed.
Products intended for one specific type of paint removal project
can be easily used in a different setting, including by consumers or
hobbyists (Refs. 8, 9, 10, and 25). Additionally, consumers can easily
use paint removal products intended for or marketed to professional
users since paint removal products are readily available at many big
box, local hardware, and paint specialty stores. It should be noted
that, while voluntary, several retailers have committed to phase out
methylene chloride paint and coating removal products. EPA identified
59 different products for paint and coating removal that contain
methylene chloride, formulated by 10 different firms. This is
approximately 54% of the total number of paint and coating removal
products EPA identified (109 products) (Ref. 24). Paint and coating
removers containing methylene chloride are frequently sold at stores
that sell products to consumers as well as professional users.
Additionally, due to the wide availability of products available on the
internet and through various additional suppliers that serve commercial
and consumer customers, consumers may foreseeably purchase a variety of
paint and coating removal products containing methylene chloride. EPA
estimated that approximately 1.3 million consumers and residential
bystanders who use or are exposed to methylene chloride through
consumer paint and coating removal each year (Ref. 4).
2. Regulatory considerations. To identify the regulatory approach
that would address the unreasonable risk presented by methylene
chloride in paint and coating removal, EPA analyzed a wide range of
regulatory options under section 6(a) in the proposed rule (Ref. 3 at
pp. 7472, 7479).
Section 6(c)(2)(A) of TSCA requires EPA, in proposing and
promulgating section 6(a) rules, to include a statement addressing
certain factors, including the costs and benefits and the cost
effectiveness of the regulatory action and of the one or more primary
alternative regulatory actions considered by the Administrator. In the
proposed rule, EPA described its consideration of several alternative
regulatory actions. One of the proposal's primary alternative
regulatory actions consisted of: (i) An occupational respiratory
protection program for the commercial uses proposed for regulation;
(ii) a prohibition on distribution in commerce of methylene chloride
for paint and coating removal in containers with a volume of less than
55 gallons and 5 gallons for certain formulations as a means of
limiting consumer access to methylene chloride paint and coating
removal products (though it did not include restrictions on
manufacturing, processing, or distribution of methylene chloride for
consumer paint and coating removal); and (iii) required downstream
notification.
Since this final rule is not addressing commercial paint and
coating removal, the primary alternative regulatory action considered
in this final rule is slightly modified from the proposed rule, in that
it does not include the occupational respiratory protection program for
the commercial uses. Therefore, the primary alternative regulatory
action for this final rule consists of: (a) Prohibition on distribution
in commerce of methylene chloride for paint and coating removal in
containers with a volume of less than 55 gallons and 5 gallons for
certain formulations; and (b) downstream notification.
This final regulatory action is consistent with the regulatory
action proposed, which includes a prohibition on the manufacture,
processing and distribution in commerce of methylene chloride for
consumer paint and coating removal. The primary alternative regulatory
action considered would have imposed additional mitigation measures to
address the risk to consumers (i.e. 55-gallon containers) with
additional burdens to processors and distributors; however, by
eliminating access to methylene chloride for consumer paint and coating
removal, via the retailer distribution restrictions, the unreasonable
risk for consumer paint and coating removal use is addressed.
The cost of the final rule is less than the cost of the primary
alternative regulatory action considered. EPA's assessment of the costs
and benefits of the primary alternative regulatory action are described
in the Economic Analysis (Ref. 4) and in Unit III.A.3.
3. TSCA section 6(c)(2) considerations. TSCA section 6(c)(2)(A)
requires EPA to consider and publish a statement based on reasonably
available information with respect to the chemical's effects on health
and the magnitude of human exposure to the chemical. The following is
EPA's statement with respect to this final rule.
i. Health effects, exposure, and environmental effects. Methylene
chloride is a neurotoxicant that can be acutely lethal. Exposure to
methylene chloride can result in a range of adverse health effects,
including effects on the nervous system, liver, respiratory system,
kidneys, and reproductive systems. Methylene chloride is also a likely
human carcinogen. The magnitude of exposure of human beings to
methylene chloride use in consumer paint and coating removal is
characterized by the number of users, in the case of this final action
is estimated to be 1.3 million consumers and
[[Page 11427]]
residential bystanders who may not be engaged in paint and coating
removal but who are exposed via inhalation to the chemical as a result
of consumer paint and coating removal each year (Ref. 4). While
methylene chloride is moderately persistent, given its low
bioaccumulation and low hazard for aquatic toxicity (Ref. 2), the
magnitude of potential environmental impacts on ecological receptors is
judged to be low for the environmental releases associated with
methylene chloride in consumer paint and coating removal (Ref. 3 at pp.
7468, 7489).
ii. The benefits of the chemical substance or mixture for various
uses. Methylene chloride use in paint and coating removal provides
benefits for some users because it is readily available and works
quickly and effectively on nearly all coatings without damaging most
substrates. In addition to paint and coating removal, methylene
chloride is a solvent used in a variety of industrial, commercial and
consumer use applications, including adhesives, pharmaceuticals, metal
cleaning, chemical processing, and feedstock in the production of
refrigerant hydrofluorocarbon-32 (Ref. 3 at p. 7467).
iii. The reasonably ascertainable economic consequences of the
rule. The reasonably ascertainable economic consequences of this rule
include several components, all of which are described in the Economic
Analysis for this final rule (Ref. 4). With respect to the anticipated
effects of this rule on the national economy, EPA considered the number
of businesses and workers that would be affected and the costs and
benefits to those businesses and workers and did not find that there
would be a significant impact on the national economy. In addition, EPA
considered the employment impacts of this final rule, and found that
the direction of change in employment is uncertain, but EPA expects the
short-term and longer-term employment effects to be small. EPA
estimates that impacts on small businesses are insignificant; EPA
estimates that this final rule would affect approximately 7 small
entities, with all small businesses having a cost impact of less than
1% of the annual revenue.
With respect to this rule's effect on technological innovation, EPA
expects this rule to spur innovation, not hinder it. A prohibition on
the manufacture, processing, and distribution of this use of methylene
chloride is likely to increase demand for chemical substitutes. This
rule is not likely to have significant effects on the environment,
though it does present the potential for small reductions in air
emissions and soil contamination associated with improper disposal of
paint and coating removers containing methylene chloride. The effects
of this rule on public health are estimated to be positive, due to the
prevention of deaths from consumer exposure to methylene chloride when
engaging in paint and coating removal with these products.
The costs and benefits that can be monetized for this rule are
described at length in Unit III.F and in the Economic Analysis (Ref.
4). The costs for this rule are estimated to range from $3.8 to $13.6
million annualized over 20 years at a 3% discount rate and $3.8 to
$13.7 million annualized over 20 years at a 7% discount rate. The
monetized benefits are estimated to be $3.5 million per year over 20
years at 3% and 7% discount rate. This reflects the benefit to
consumers.
EPA considered the estimated costs to regulated entities as well as
the cost to administer and enforce alternative regulatory actions. The
primary alternative regulatory action would not include restrictions on
manufacturing, processing, or distribution of methylene chloride for
consumer paint and coating removal, but it would prohibit the
distribution in commerce of methylene chloride for paint and coating
removal in containers with a volume of less than 55 gallons, or 5
gallons for certain formulations. In addition, downstream notification
and recordkeeping would be required. The estimated annualized costs of
this alternative regulatory action are $5.8 to $16.8 million at 3% and
$5.8 to $16.8 million at 7% over 20 years (Ref. 4). The estimated
annualized benefits of this alternative regulatory action are $13.0 to
$13.1 million at 3% and $12.8 million at 7% over 20 years (Ref. 4).
This reflects the $3.5 million per year benefits to consumers noted
above and additional benefits to commercial users not targeted by the
rule.
The regulatory action finalized today is more cost effective than
the primary alternative regulatory action because it achieves the
necessary risk reduction for consumers and bystanders with estimated
lower costs than the alternative regulatory action. The cost of the
alternative regulatory action was estimated to be higher due to the
cost of compliance with the container volume requirements which impact
commercial users not targeted by the rule. However, the net benefits of
the final regulatory action are estimated to be lower than the net
benefits of the primary alternative regulatory action, since the
primary alternative regulatory action includes benefits from preventing
consumer users' exposure to methylene chloride in paint and coating
removal, whereas the final regulatory action only includes benefits
from eliminating consumer exposures to methylene chloride in paint and
coating removal (Ref. 4).
iv. Consideration of alternatives. In addition to the statement of
effects and analysis of alternative regulatory actions required under
TSCA section 6(c)(2)(A), section 6(c)(2)(C) requires EPA to consider,
in deciding whether to prohibit or restrict in a manner that
substantially prevents a specific condition of use, whether technically
and economically feasible alternatives (e.g., substitute chemicals or
alternative methods) that benefit health or the environment will be
reasonably available as a substitute when the prohibition or
restriction takes effect. In the proposed rule, EPA requested comment
on the accuracy of its conclusion that identified substitutes for
methylene chloride which are reasonably available and technically and
economically feasible, and whether its consideration of chemical
substitutes and alternative methods met the requirements of TSCA
section 6(c)(2)(C). EPA received several comments on this subject. A
majority of commenters indicated that effective, safer alternatives are
already available for paint and coating removal, and that EPA has amply
satisfied TSCA section 6(c)(2)(C) requirements by identifying a number
of available, preferable substitutes, including non-chemical
substitutes. Some commenters raised concerns regarding alternatives and
claimed EPA failed to satisfy the requirements of TSCA section
6(c)(2)(C) because the Agency erroneously concluded that technically
and economically feasible alternative paint strippers exist. EPA
disagrees with the comments that for consumer users, available
alternative formulations are less safe and more expensive than products
with methylene chloride, although EPA does recognize that many factors
need to be considered when choosing the appropriate alternative.
Substitute products currently are available for consumer users of
methylene chloride for paint and coating removal, for a variety of
coatings on numerous substrates (Refs. 26 and 27). None of the
substitute chemicals already available has the level of toxicity
associated with methylene chloride (Ref. 24). As EPA stated in the
proposed rule, EPA is aware of technically and economically feasible
chemical substitutes or alternative methods that are reasonably
available to a consumer for almost every situation in
[[Page 11428]]
which methylene chloride is used to remove paints or coatings (Ref. 3
at p. 7485). A summary of comments related to substitute products, and
EPA's response, is in the docket for this action (Ref. 15).
4. TSCA section 9(a) analysis. Section 9(a) of TSCA describes the
steps EPA must take if the EPA Administrator determines in his
discretion that an unreasonable risk may be prevented or reduced to a
sufficient extent by an action taken under a Federal law not
administered by EPA. These steps include submitting a report to the
agency administering that other law that describes the risk and the
activities that present such risk. EPA has not made such a
determination, and, in the proposed rule, EPA explained its reasoning.
TSCA section 9(d) further instructs the Administrator to consult and
coordinate TSCA activities with other Federal agencies for the purpose
of achieving the maximum enforcement of TSCA while imposing the least
burden of duplicative requirements. In the proposed rule, EPA described
its consultations with CPSC and with OSHA, and letters documenting this
consultation are in the docket (Refs. 28 and 29).
CPSC's mission is to protect the public from unreasonable risks of
injury or death associated with the use of consumer products under the
agency's jurisdiction. CPSC recently updated its guidance on labeling
for certain products containing methylene chloride to explain that
covered products that do not bear a prominent warning about the risk of
death in enclosed spaces are considered misbranded hazardous substances
under the Federal Hazardous Substances Act, 15 U.S.C. 1261-1276. One of
the specifically-stated purposes for the update was to provide more
immediate guidance and clarity to consumers and industry regarding the
acute hazards associated with using methylene chloride based paint
removers while they remain on the market (83 FR 12254, March 21, 2018).
In that guidance, CPSC specifically stated that, ``we do not suggest
that labeling will address all hazards EPA identified in its proposed
rulemaking'' regarding methylene chloride use in paint and coating
removal products. While EPA believes that the updated CPSC labeling
guidance, if properly implemented by industry, would prevent some users
from using methylene chloride paint and coating removal products in an
unsafe manner, for the reasons described in the proposal, it is
unlikely to mitigate the unreasonable risks to consumers identified by
EPA so that they are no longer unreasonable.
OSHA's mission is to assure safe and healthful working conditions
for working men and women by setting and enforcing standards and by
providing training, outreach, education and assistance. OSHA's
authority does not address unreasonable risk from methylene chloride in
consumer paint and coating removal.
In this final rule, EPA has not used its discretion to make a
determination that unreasonable risks from the use of methylene
chloride in consumer paint and coating removal may be prevented or
reduced to a sufficient extent by an action taken under a Federal law
not administered by EPA, and therefore there is no need to submit a
report to CPSC or OSHA under TSCA section 9(a).
More than 20 comments were received regarding issues generally
related to TSCA section 9. Some commenters supported EPA's decision to
not make a determination and submit a report to another agency under
TSCA section 9(a). These commenters agreed with EPA's reasoning on the
ability of other authorities to address the unreasonable risks
identified by EPA. Other commenters contended that the OSHA regulations
and the CPSC labeling guidance were sufficient to address the risks EPA
identified, especially given the fact that CPSC was in the process of
revising its labeling guidance for methylene chloride. Others thought
that, to the extent that EPA had identified risks to consumers and
others that were not adequately addressed by the current CPSC guidance
or OSHA regulations, a report from EPA under TSCA section 9(a) would
have alerted the other agencies to the potential deficiencies.
In this case, EPA disagrees with those commenters who thought that
EPA must make a determination that other authorities administered by
other agencies could address the unreasonable risks identified by EPA.
5. TSCA section 9(b) analysis. TSCA section 9(b) directs EPA to use
other authorities administered by EPA to protect against a risk to
health or the environment if EPA determines that such risk could be
eliminated or reduced to a sufficient extent by actions taken under
those authorities, unless EPA determines that it is in the public
interest to protect against such risk by actions taken under TSCA.
Although several EPA statutes have been used to limit methylene
chloride exposure, as described in the proposed rule, the acute
unreasonable risks EPA has identified could not be addressed through
these other statutes.
For this reason, the Administrator is not making a determination
that the unreasonable risks of injury to health due to acute human
lethality from the use of methylene chloride in consumer paint and
coating removal could be eliminated or reduced to a sufficient extent
by actions taken under other Federal laws administered in whole or in
part by EPA. Another commenter stated that EPA failed to meet its
obligations under TSCA section 9(b) because EPA did not compare the
estimated costs and efficiencies of acting under TSCA or other statutes
administered by EPA. EPA disagrees with this commenter's reading of
TSCA section 9(b). The obligation to compare costs and efficiencies
only arises after EPA has first determined that the identified
unreasonable risks could be adequately addressed through action under
another statute administered by EPA, and also determines that it is in
the public interest to act under TSCA rather than the other statute. In
this case, EPA has made neither of those determinations.
6. TSCA section 26(h) considerations. EPA has used scientific
information, technical procedures, measures, methods, protocols,
methodologies, and models consistent with the best available science at
the time the risk assessment for methylene chloride was conducted.
These information sources supply information relevant to whether the
use of methylene chloride in paint and coating removal would present an
acute unreasonable risk. For example, the 2014 risk assessment used
best available science and methods, was peer reviewed, and went through
a public comment process (Ref. 2).
The clarity and completeness of the data, assumptions, methods,
quality assurance, and analyses employed in EPA's decision are
documented, as applicable and to the extent necessary for purposes of
this final rule, in the proposed rule (Ref. 3 at p. 7521) and in the
references cited throughout the preamble of the proposed and this final
rule. While EPA recognizes, based on the available information, that
there is variability and uncertainty with regard to EPA's risk
assessment of the use of methylene chloride in paint and coating
removal, those uncertainties were identified in the proposed rule (Ref.
3 at p. 7491) and were characterized and documented in the methylene
chloride risk assessment (Ref. 2). The extent to which the various
information, procedures, measures, methods, protocols, methodologies or
models, as applicable, used in EPA's decision have
[[Page 11429]]
been subject to independent verification or peer review is adequate to
justify their use, collectively, in the record for this rule.
Additional information on the peer review and public comment process,
such as the peer review plan, the peer review report, and EPA's
response to comments, is in Docket Number EPA-HQ-OPPT-2012-0725.
EPA received several public comments on the proposed rule relating
to the scientific information, technical procedures, measures, methods,
protocols, methodologies, and models used by EPA. Commenters disagreed
on whether EPA's assessment of methylene chloride was scientifically
rigorous, with some praising EPA for a strong scientific underpinning
for the regulation and others stating that EPA did not use best
available science by incorporating exposure data that were out of date
or by not correctly using a weight-of-evidence for some findings. EPA
disagrees with commenters that the exposure data should not be used, or
that weight-of-evidence was applied incorrectly. This action based on
acute unreasonable risks is supported by a risk assessment that
underwent peer review and a public comment process. More details on
these comments and EPA's response is in the Response to Comments
document (Ref. 15).
B. Prohibitions and Requirements
This final rule:
1. Prohibits the manufacturing, processing, and distribution in
commerce of methylene chloride for paint and coating removal for all
consumer uses;
2. Prohibits the distribution in commerce of methylene chloride in
paint and coating removal products to and by retailers. A retailer is
any person or business entity that distributes or makes available paint
and coating removal products to consumers, including through ecommerce
internet sales or distribution. If a person or business entity
distributes or makes available any methylene chloride-containing paint
or coating removal product to at least one consumer, then it is
considered a retailer. For a distributor not to be considered a
retailer, he/she must distribute or make available methylene chloride-
containing paint and coating removal products solely to commercial or
industrial end users or businesses. This additional provision clarifies
the proposed regulation and ensures that retailers will not be able to
purchase for sale or distribution to consumers, or to make available to
consumers, paint and coating removal products containing methylene
chloride;
3. Requires manufacturers, processors, and distributors of
methylene chloride for any use, excluding retailers, to provide
downstream notification of the prohibitions in this final rule through
SDSs by adding to sections 1(c) and 15 of the SDS the following
language: ``This chemical/product is not and cannot be distributed in
commerce (as defined in TSCA section 3(5)) or processed (as defined in
TSCA section 3(13)) for consumer paint or coating removal.''; and
4. Requires recordkeeping relevant to these prohibitions.
The prohibition on manufacturing, processing, and distribution in
commerce of methylene chloride for consumer paint and coating removal,
including distribution to and by retailers, will take effect 180 days
after the effective date of this final rule. EPA believes this is a
reasonable transition period and will not result in additional costs of
collecting and disposal of any stranded products. EPA recognizes that
some individual retailers might not be as efficient with their
inventory management and that could result in stranded products and
some additional cost for disposal of such products.
Each person who manufactures, processes, or distributes in commerce
methylene chloride is required to provide downstream notification of
the restrictions in this rule through SDSs, effective 90 days following
the effective date of this final rule. Downstream notification ensures
that processors and distributors are aware of the restrictions for
methylene chloride in paint and coating removal; enhances the
likelihood that the risks associated with this use of methylene
chloride are addressed throughout the supply chain; and also
streamlines compliance and enhances enforcement, since compliance is
improved when rules are clearly and simply communicated (Ref. 30).
After 90 days following the effective date of this final rule, each
person who manufactures, processes, or distributes in commerce
methylene chloride must retain documentation of the entities to whom
methylene chloride was shipped, a copy of the downstream notification
provided, and the amount of methylene chloride shipped. The
documentation must be retained for 3 years from the date of shipment.
Based on a public comment, EPA added to the final rule a provision to
keep the required records either at the company's headquarters or at
the facility for which the records were generated.
This final rule also includes a definition of retailers and
consumer paint and coating removal in order to be responsive to
comments received requesting EPA to provide more clarity regarding the
regulated distribution to consumers.
C. Downstream Notification
EPA received four comments related to downstream notification of
methylene chloride restrictions, one of which took issue with EPA's
approach. This commenter stated that EPA lacks the authority to require
downstream notification and recordkeeping beyond the scope of the
conditions of use identified in its unreasonable risk finding. While
EPA recognizes there are companies likely manufacturing, processing, or
distributing methylene chloride or products containing methylene
chloride for uses that will not be regulated under this final rule, EPA
disagrees with the commenter's reading of the statute that section
6(a)(3) downstream notification requirements do not apply to conditions
of use other than those for which EPA is addressing the unreasonable
risk for a chemical substance.
TSCA section 6(a) requires EPA to impose one or more of the
specified requirements to the extent necessary so that a chemical
substance no longer presents an unreasonable risk identified by EPA.
Here, EPA has determined that the downstream notification provisions
are necessary to prevent the identified unreasonable risk. Without
downstream notification, manufacturers, processors, and distributors,
are likely to be unfamiliar with the prohibitions against distribution
of methylene chloride-containing paint and coating removal products to
and by retailers. As such, the notification helps ensure that all
downstream entities are aware of the prohibitions. Further,
notification throughout the supply chain streamlines compliance and
enhances enforcement, since compliance can be improved when rules are
clearly and simply conveyed. Moreover, under section 6, EPA has
authority to require reporting and recordkeeping related to the
regulatory requirements imposed by EPA under section 6. See, e.g., 55
FR 222 (EPA's section 6 action on hexavalent chromium in cooling
towers).
Some commenters requested more clarity from EPA regarding how to
use the SDS for downstream notification. In this final rule, EPA is
specifying the changes to the SDS needed for the downstream
notification. Specifically, EPA is requiring the addition of the
following language to sections 1(c) and 15 of the SDS: ``This chemical/
product is not and cannot be distributed in commerce (as defined in
TSCA section
[[Page 11430]]
3(5)) or processed (as defined in TSCA section 3(13)) for consumer
paint or coating removal.''
The effective date of the requirement for this notification and the
associated recordkeeping is 90 days after the effective date of this
action. The proposed rule would have had these requirements take effect
45 days after the effective date of this final rule. On further
reflection, EPA has determined that 90 days is a more reasonable
transition period. Regulated entities need only to provide additional
information on their SDS, which is routinely produced and updated.
D. Import Certification
Persons who import any chemical substance governed by a final TSCA
section 6 rule are subject to the TSCA section 13 (15 U.S.C. 2612)
import certification requirements and the corresponding regulations at
19 CFR 12.118 through 12.127; see also 19 CFR 127.28. To comply with
the import certification requirements, importers (or their agents) will
be required to certify that the shipment of methylene chloride complies
with all applicable rules and orders under TSCA. The EPA policy in
support of import certification appears at 40 CFR part 707, subpart B.
In addition, any persons who export or intend to export methylene
chloride are subject to the export notification provisions of TSCA
section 12(b) (15 U.S.C. 2611(b)), and must comply with the export
notification requirements in 40 CFR part 707, subpart D.
E. Enforcement
Section 15 of TSCA makes it unlawful to fail or refuse to comply
with any provision of a rule promulgated under TSCA section 6.
Therefore, any failure to comply with this rule when it becomes
effective would be a violation of section 15 of TSCA. In addition,
section 15 of TSCA makes it unlawful for any person to: (1) Fail or
refuse to establish and maintain records as required by this rule; (2)
fail or refuse to permit access to or copying of records, as required
by TSCA; or (3) fail or refuse to permit entry or inspection as
required by section 11 of TSCA.
Violators may be subject to both civil and criminal liability.
Under the penalty provision of section 16 of TSCA, any person who
violates section 15 could be subject to a civil penalty for each
violation. Each day in violation of this final rule, after the
effective date could constitute a separate violation. Knowing or
willful violations could lead to the imposition of criminal penalties
for each day of violation and imprisonment. In addition, other remedies
are available to EPA under TSCA.
Individuals, as well as corporations, could be subject to
enforcement actions. Sections 15 and 16 of TSCA apply to ``any person''
who violates various provisions of TSCA. EPA may, at its discretion,
proceed against individuals as well as companies. In particular, EPA
may proceed against individuals who report false information or cause
it to be reported.
F. Costs, Benefits, and Impacts
EPA evaluated the costs and benefits of this final action, which is
presented in the Economic Analysis (Ref. 4) and summarized in this
unit.
1. Overview of public comments. Of the nine comments received
related to the Economic Analysis, three comments supported EPA's
Economic Analysis. One commenter stated that EPA conducted a thorough
cost-benefit analysis, and appropriately provided an in depth
qualitative description of health benefits. Other commenters pointed
out perceived shortcomings of the Economic Analysis conducted by the
Agency, with one commenter calling for the underlying Economic Analysis
data to be more comprehensive, accurate, and reflective of current
industry practices. These comments, and EPA's response, are in the
Response to Comments document in this docket (Ref. 15).
2. Costs. The details of the costs of this final rule are
summarized in Unit I.E and discussed in the Economic Analysis (Ref. 4).
Under this final rule, costs to users of paint and coating removal
products containing methylene chloride are approximately $3.8 to $13.6
million annualized for 20 years at a discount rate of 3% and $3.8 to
$13.7 million at a discount rate of 7%. Costs to manufacturers of
methylene chloride are $50 and $60 annualized for 20 years at a
discount rate of 3% and 7% respectively. Costs for processors,
including those associated with reformulation, downstream notification
and label changes, on an annualized basis over 20 years are $ 15,000 to
$25,000 using 3% and $20,000 to $34,000 using 7% discount rates. Agency
costs for enforcement are estimated to be approximately $147,000 and
$145,000 annualized over 20 years at 3% and 7%, respectively. Total
costs of this final rule are estimated to be approximately $3.8 to
$13.6 million annualized over 20 years at 3% and $3.8 to $13.7 million
annualized over 20 years at 7%.
3. Benefits. EPA is not fully able to quantify the full monetary
benefits that would accrue from preventing all consumer deaths due to
methylene chloride in paint and coating removal and the impacts of the
substitution effect by switching from methylene chloride to alternative
chemicals and methods. Similarly, EPA is not able to monetize the
benefits that would accrue from preventing non-fatal and non-cancer
effects from exposure to methylene chloride in paint and coating
removal. The subset of benefits that can be monetized from mitigating
the risks from methylene chloride in paint and coating removal for
consumers finalized by this rule are potential avoidance of fatalities
and are estimated to be approximately $3.5 million (annualized at 3%
and 7% over 20 years) (Ref. 4).
4. Comparison of benefits and costs. The monetized subset of
benefits from preventing the risks resulting from methylene chloride in
consumer paint and coating removal are less than the estimated monetary
costs.
5. Impacts on the national economy, small businesses, technological
innovation, the environment, and public health. As summarized in Unit
I.E and III.A.3 and described in the Economic Analysis (Ref. 4), EPA
considered the anticipated effects of this final rule. With respect to
the national economy, as EPA indicated in the proposed rule (Ref. 3 at
p. 7489), EPA considered the number of businesses and workers that
would be affected and the costs and benefits to those businesses and
workers. EPA did not find that there would be a significant impact on
the national economy (Ref. 4). In addition, EPA considered the
employment impacts of this final rule, and found that the direction of
change in employment is uncertain, but EPA expects the short term and
longer-term employment effects to be small (Ref. 4). EPA estimates that
impacts on small businesses are insignificant; EPA estimates that this
final rule would affect approximately 7 small entities, with all small
businesses having a cost impact of less than 1% of the annual revenue,
(Ref. 4). As EPA indicated in the proposed rule, with respect to this
rule's effect on technological innovation, EPA expects this action to
spur innovation, not hinder it. A prohibition on the manufacturing,
processing, and distribution in commerce of methylene chloride for
consumer paint and coating removal is likely to increase demand for
alternatives (Ref. 4). This rule is not likely to have significant
effects on the environment, though it does present the potential for
small reductions in air emissions and soil contamination associated
with improper disposal of paint and coating removers containing
[[Page 11431]]
methylene chloride. The effects of this rule on public health are
estimated to be positive, due to the prevention of deaths and nonlethal
adverse health effects due to consumer exposure to methylene chloride
when engaging in paint and coating removal (Ref. 3 at p. 7489).
6. Impacts of the final and alternative regulatory actions. The
costs of this final rule are estimated to include costs to users of
paint and coating removal products containing methylene chloride,
product reformulation costs, downstream notification costs,
recordkeeping costs, and Agency costs.
The primary alternative regulatory action considered by EPA would
not include restrictions on manufacturing, processing, or distribution
of methylene chloride for consumer paint and coating removal, but it
would require the distribution in commerce of methylene chloride for
paint and coating removal in containers with a volume of no less than
55 gallons, or 5 gallons for certain formulations. In addition,
downstream notification and recordkeeping would be required. As
required under TSCA section 6(c), EPA analyzed the costs and benefits
of this primary alternative action and found that this approach would
introduce additional burdens to processors and distributors who would
bear the cost of ensuring products are in 55- and 5-gallon containers,
as appropriate. In addition, the 55-gallon volume restriction would
effectively bar most commercial users in the professional contractor,
bathtub refinishing, and graffiti removal sectors given the increased
cost and, for some users, impracticality of using large containers.
The regulatory action finalized today is more cost effective
because it achieves the necessary risk reduction for consumers and
bystanders with estimated lower costs than the alternative regulatory
action. The cost of the alternative regulatory action was estimated to
be higher due to the cost of compliance with the container volume
requirements. However, the net benefits of the final regulatory action
are estimated to be lower than the net benefits of the primary
alternative regulatory action, since the primary alternative regulatory
action includes benefits from preventing consumer users' exposure,
whereas the final regulatory action only includes benefits from
eliminating consumer exposures to methylene chloride in paint and
coating removal. A summary of the findings of this analysis are in
III.A.3 and in the Economic Analysis (Ref. 4).
IV. References
The following is a listing of the documents that are specifically
referenced in this document. The docket includes these documents and
other information considered by EPA, including documents referenced
within the documents that are included in the docket, even if the
referenced document is not physically located in the docket. For
assistance in locating these other documents, please consult the
technical person listed under FOR FURTHER INFORMATION CONTACT.
1. EPA. TSCA Work Plan for Chemical Assessments: 2014 Update.
https://www.epa.gov/sites/production/files/2015-01/documents/tsca_work_plan_chemicals_2014_update-final.pdf. Retrieved December
4, 2018.
2. EPA. TSCA Work Plan Chemical Risk Assessment Methylene Chloride:
Paint Stripping Use. CASRN 75-09-2. EPA Document# 740-R1-4003.
August 2014. Office of Chemical Safety and Pollution Prevention.
Washington, DC https://www.epa.gov/sites/production/files/2015-09/documents/dcm_opptworkplanra_final.pdf. Retrieved December 4, 2018.
3. EPA. Methylene Chloride and N-Methylpyrrolidone; Regulation of
Certain Uses Under TSCA Section 6(a); Proposed Rule. Federal
Register (82 FR 7464, January 19, 2017) (FRL-9958-57).
4. EPA. Economic Analysis of Final Rule TSCA Section 6 Action on
Methylene Chloride in Paint and Coating Removal (EPA Docket EPA-HQ-
OPPT-2016-0231; RIN 2070-AK07). Office of Pollution Prevention and
Toxics. Washington, DC.
5. EPA. Toxicological Review of Methylene Chloride (CAS No. 75-09-
2). EPA/635/R-10/003F. Integrated Risk Information System,
Washington, DC. November 2011.
6. EPA. Public Database 2016 Chemical Data Reporting (May 2017
Release). Washington, DC: US Environmental Protection Agency, Office
of Pollution Prevention and Toxics. Retrieved from https://www.epa.gov/chemical-data-reporting.
7. EPA. Scope of the Risk Evaluation for Methylene Chloride
(Dichloromethane, DCM) EPA-HQ-OPPT-2016-0742-0061. Office of
Pollution Prevention and Toxics. Washington, DC. June 2017.
8. OSHA. ``Lethal Exposure to Methylene Chloride during Bathtub
Refinishing.'' OSHA Fatal Facts. 2016. https://www.osha.gov/Publications/OSHA3883.pdf.
9. Centers for Disease Control and Prevention (CDC). ``Fatal
Exposure to Methylene Chloride Among Bathtub Refinishers--United
States, 2000-2011.'' Morbidity and Mortality Weekly Report. February
24, 2012. Vol 61(7), p 119-122.
10. EPA. Memo: Methylene Chloride Paint and Coating Removal
Fatalities: 2017-2018. (EPA Docket EPA-HQ-OPPT-2016-0231). Office of
Pollution Prevention and Toxics. Washington, DC.
11. California Code of Regulations. ``Proposal to List Paint or
Varnish Strippers Containing Methylene Chloride as a Priority
Product.'' Proposed Regulation Text. November 2017. https://calsafer.dtsc.ca.gov/cms/commentpackage/?rid=12734.
12. ``Proposition 65 Law and Regulations.'' Nov 14, 2016. http://www.oehha.ca.gov/prop65/law/P65law72003.html.
13. EPA. TSCA Work Plan Chemicals: Methods Document. http://www.epa.gov/sites/production/files/2014-03/documents/work_plan_methods_document_web_final.pdf. Retrieved February 25,
2016.
14. EPA. Final Report of the Small Business Advocacy Review Panel on
EPA's Planned Proposed Rule on the Toxic Substances Control Act
(TSCA) Section 6(a) as amended by the Frank R. Lautenberg Chemical
Safety for the 21st Century Act for Methylene Chloride and N-
Methylpyrrolidone (NMP) in Paint Removers. Office of Chemical Safety
and Pollution Prevention. Washington, DC. 2016.
15. EPA. Response to Comments on the Final Methylene Chloride Rule;
Regulation of Certain Uses Under TSCA Section 6(a) (EPA Docket EPA-
HQ-OPPT-2016-0231). Office of Pollution Prevention and Toxics.
Washington, DC.
16. EPA. Outreach Meeting with W. M. Barr and EPA to discuss the
Methylene Chloride in Paint and Coating Removal. (EPA Docket EPA-HQ-
OPPT-2016-0231). Office of Pollution Prevention and Toxics.
Washington, DC.
17. EPA Outreach Meeting with Breast Cancer Prevention Partners
(BCPP) and Safer Chemicals Healthy Families (SCHF) and EPA to
discuss the Methylene Chloride in Paint and Coating Removal. (EPA
Docket EPA-HQ-OPPT-2016-0231) Office of Pollution Prevention and
Toxics. Washington, DC.
18. EPA Outreach Meeting with Natural Resources Defense Council and
Safer Chemicals Healthy Families (SCHF) and EPA to discuss the
Methylene Chloride in Paint and Coating Removal. (EPA Docket EPA-HQ-
OPPT-2016-0231) Office of Pollution Prevention and Toxics.
Washington, DC.
19. EPA Meeting with families who have lost relatives using
methylene chloride in paint removal. (EPA Docket EPA-HQ-OPPT-2016-
0231) Office of Pollution Prevention and Toxics. Washington, DC.
20. EPA. Demonstration of Paint Removing products by W.M. Barr. (EPA
Docket EPA-HQ-OPPT-2016-0231) Office of Pollution Prevention and
Toxics. Washington, DC.
21. EPA. Outreach Meeting with Federal and State Agencies on Recent
Methylene Chloride Fatalities. (EPA Docket EPA-HQ-OPPT-2016-0231).
Office of Pollution Prevention and Toxics. Washington, DC.
22. ``Paint Strippers, Types of Strippers.'' PaintPRO, Vol. 3, No.
3. June 2000. http://www.paintpro.net/Articles/PP303/PP303_strippers.cfm.
[[Page 11432]]
23. EPA. Trichloroethylene; Regulation of Certain Uses Under TSCA
Section 6(a); Proposed Rule. Federal Register (81 FR 91592, December
16, 2016) (FRL-9949-86).
24. EPA. Analysis Report of Chemical Alternatives for Use of
Methylene Chloride[hyphen] and N-Methylpyrrolidone[hyphen]based
Paint Removers: Hazard and Exposure Concerns. 2016.
25. National Institute for Occupational Safety and Health (NIOSH)
and Occupational Safety and Health Administration (OSHA). Hazard
Alert: Methylene Chloride Hazards for Bathtub Refinishers. January
2013. http://www.cdc.gov/niosh/docs/2013-110/Accessed April 14,
2016.
26. Morris, M.; Wolf, K. Institute for Research and Technical
Assistance. ``Methylene Chloride Consumer Product Paint Strippers:
Low-VOC, Low Toxicity Alternatives Prepared For: Cal-EPA's
Department of Toxic Substances Control.'' May 2006. http://www.irta.us/Methylene%20Chloride%20Consumer%20Product%20Paint%20Strippers%20REPORT%20ONLY.pdf.
27. Jacobs, Molly; Bingxuan Wang, Mark Rossi. ``Alternatives to
Methylene Chloride in Paint and Varnish Strippers.'' BizNGO. (2015):
1-44. http://www.bizngo.org/resources/entry/resource-methylene.
28. United States Consumer Product Safety Commission (CPSC). Letter
to James J. Jones from Patricia H. Adkins. April 19, 2016.
29. U.S. Department of Labor--Occupational Safety and Health
Administration (OSHA). Letter to James J. Jones from David Michaels,
Ph.D., MPH. March 31, 2016.
30. Giles, C. EPA. ``Next Generation Compliance.'' Environmental
Forum. October 2013, p 22-26. Washington, DC.
31. EPA. Final Regulatory Flexibility Analysis for Methylene
Chloride; Regulation of Certain Uses Under TSCA Section 6(a); Final
Rule; RIN 2070-AK07. Office of Chemical Safety and Pollution
Prevention. Washington, DC. 2019.
32. EPA. Supporting Statement for an Information Collection Request
(ICR) Under the Paperwork Reduction Act (PRA). March 2019.
33. EPA. Section 6(a) Rulemakings under the Toxic Substances Control
Act (TSCA) Paint Removers & TCE Rulemakings E.O. 13132: Federalism
Consultation. May 13, 2015.
34. EPA. Notification of Consultation and Coordination on Proposed
Rulemakings under the Toxic Substances Control Act for 1) Methylene
Chloride and n-Methylpyrrolidone in Paint Removers and 2)
Trichloroethylene in Certain Uses. April 8, 2015.
35. EPA. Paint Removers: Methylene Chloride and N-
Methylpyrrolidone--Community Webinar. May 28, 2015.
V. Statutory and Executive Order Reviews
Additional information about these statutes and Executive Orders
can be found at http://www2.epa.gov/laws-regulations/laws-and-executive-orders.
A. Executive Order 12866: Regulatory Planning and Review and Executive
Order 13563: Improving Regulation and Regulatory Review
This action is a significant regulatory action that was submitted
to the Office of Management and Budget (OMB) for review under Executive
Order 12866 (58 FR 51735, October 4, 1993) and Executive Order 13563
(76 FR 3821, January 21, 2011). Any changes made in response to OMB
recommendations have been documented in the docket. EPA prepared an
economic analysis of the potential costs and benefits associated with
this action, which is available in the docket and summarized in Units
I.E., III.A.3., and III.G. (Ref. 4).
B. Executive Order 13771: Reducing Regulation and Controlling
Regulatory Costs
This action is subject to the requirements for regulatory actions
specified in Executive Order 13771 (82 FR 9339, February 3, 2017).
Details on the estimated costs of this final rule can be found in EPA's
analysis (Ref. 4) of the potential costs and benefits associated with
this action, which is available in the docket and is summarized in Unit
III.F.
C. Paperwork Reduction Act (PRA)
The information collection requirements in this rule have been
submitted for approval to OMB under the PRA, 44 U.S.C. 3501 et seq. The
Information Collection Request (ICR) document prepared by EPA has been
assigned EPA ICR No. 2556.02 and OMB Control No. 2070-0204. You can
find a copy of the ICR in the docket for this rule (Ref. 32), and it is
briefly summarized here. This rule does not require the regulated
entities to submit information to EPA.
The information collection activities required by this rule include
a downstream notification requirement and a recordkeeping requirement.
The downstream notification would require companies that ship methylene
chloride to notify companies downstream in the supply chain through the
SDS of the prohibitions described in this final rule. The recordkeeping
requirement mandates companies that ship methylene chloride to retain
certain information at the company headquarters, or at the facility for
which the records were generated, for three years from the date of
shipment. These information collection activities are necessary in
order to enhance the prohibitions under this rule by ensuring awareness
of the prohibitions throughout the methylene chloride supply chain, and
to provide EPA with information upon inspection of companies downstream
who purchased methylene chloride. This rule does not require
confidential or sensitive information to be submitted to EPA or
downstream companies. EPA believes that these information collection
activities would not significantly impact the regulated entities as the
downstream notification requirements is a simple modification to the
SDS and recordkeeping requirements include information that is part of
the normal course of business.
Respondents/affected entities: Methylene chloride manufacturers,
processors, and distributors.
Respondent's obligation to respond: Respondents are not obligated
to respond or report to EPA, but must notify downstream users and
maintain required records.
Estimated number of respondents: 138.
Frequency of response: On occasion to third parties as needed.
Total estimated annual burden: 69 hours. Burden is defined at 5 CFR
1320.3(b).
Total estimated annual cost: $3,712.
An agency may not conduct or sponsor, and a person is not required
to respond to, a collection of information unless it displays a
currently valid OMB control number. The OMB control numbers are
displayed either by publication in the Federal Register or by other
appropriate means, such as on the related collection instrument or
form, if applicable. The OMB control numbers for certain EPA
regulations are listed in 40 CFR part 9.
D. Regulatory Flexibility Act (RFA)
Pursuant to sections 603 and 609(b) of the RFA, EPA prepared an
initial regulatory flexibility analysis (IRFA) for the proposed
rulemaking and convened a Small Business Advocacy Review (SBAR) Panel
to obtain advice and recommendations from small entity representatives
that potentially would be subject to the rule's requirements. Summaries
of the IRFA and Panel recommendations are presented in the proposed
rulemaking (Ref. 3).
As required by section 604 of the RFA, EPA prepared a final
regulatory flexibility analysis (FRFA) for this action (Ref. 31). The
FRFA addresses the issues raised by public comments on the IRFA for the
proposed rulemaking. The
[[Page 11433]]
complete FRFA is available for review in the docket and is summarized
here.
1. Statement of need and rule objectives. The purpose of this
action is to prevent acute fatalities from the use of methylene
chloride in consumer paint and coating removal. Under TSCA section 6(a)
(15 U.S.C. 2605(a)), if EPA determines that a chemical substance
presents an unreasonable risk of injury to health or the environment,
without consideration of costs or other non-risk factors, including an
unreasonable risk to a potentially exposed or susceptible subpopulation
identified as relevant, under the conditions of use, EPA must by rule
apply one or more requirements to the extent necessary so that the
chemical substance no longer presents such risk.
With respect to a chemical substance listed in the 2014 update to
the TSCA Work Plan for Chemical Assessments for which a completed risk
assessment was published prior to the date of enactment of the Frank R.
Lautenberg Chemical Safety for the 21st Century Act (which includes
methylene chloride), TSCA section 26(l)(4) (15 U.S.C. 2625(l)(4))
provides that EPA ``may publish proposed and final rules'' under TSCA
section 6(a) that are consistent with the scope of the completed risk
assessment and consistent with other applicable requirements of TSCA
section 6. EPA is publishing this final rule under TSCA section 6(a) in
accordance with that discretionary statutory authority.
Based on EPA's analysis of consumer population exposures to
methylene chloride in paint and coating removal, EPA is making a final
determination that the use of methylene chloride in consumer paint and
coating removal presents an unreasonable risk of injury to health due
to acute human lethality. This final rule addresses that unreasonable
risk.
EPA believes this rule will be effective in preventing unreasonable
risk from the use of methylene chloride in consumer paint and coating
removal. This final rule is informed by the TSCA Work Plan Chemical
Risk Assessment Methylene Chloride: Paint Stripping Use, as well as
information gathered from the comments on the proposed rulemaking, SBAR
panel, and public meetings. For more information on the proposed
rulemaking, SBAR panel and outreach efforts for this action, see the
docket for this rulemaking (Docket ID Number EPA-HQ-OPPT-2016-0231).
2. Significant comments on the IRFA. EPA received no comments on
the IRFA. However, EPA did receive comments related to the regulatory
options selected, alternative regulatory actions, and impacts on small
businesses. The comments received on the proposed rule and EPA's
responses as they relate to this final action are summarized in Unit
II.B.3 and in further detail in the Response to Comment Document in the
docket (Ref. 15).
3. SBA Office of Advocacy comments and EPA response. EPA received
no comments from SBA on the IRFA. SBA, however, did provide comments on
the proposed rule. Because EPA is not finalizing the proposed
regulations on NMP, EPA is not responding to the comments received
regarding NMP at this time and will take them into consideration during
the risk evaluation for that chemical. SBA's comments which pertain to
methylene chloride consumer paint and coating removal, and EPA's
responses, are in the Response to Comments document for this rule (Ref.
15) and in the FRFA (Ref. 31).
4. Estimate of the number of small entities to which the final rule
applies. EPA estimates that this final rule would affect approximately
7 small entities, specifically, a small number of formulators of paint
and coating removal products that contain methylene chloride (Ref. 32).
The cost to these small businesses will be the cost of reformulating
products sold to consumer users and the cost of complying with the
downstream notification requirements. In addition, cost impacts of a
prohibition on sale of paint and coating remover products containing
methylene chloride for consumer uses on retailers of such products is
not included in this analysis, as EPA is uncertain about the effect of
possible increased sales of alternative paint and coatings removal
products. Some of the affected retailers may be small businesses and
these retailers are not included in this discussion.
Some small business may be negatively affected by the rule.
Negative impacts may include increasing production of substitute
chemicals to replace some of the production of methylene chloride, or
updating SDS sheets, etc. EPA does not expect these impacts to be
costly but as they are tasks that will take time, effort, and resources
the firms would not otherwise expend in such a manner, EPA sees them as
negative impacts on the firms. Another negative impact may include a
small business formulator exiting the paint and coating removal product
market entirely.
5. Projected reporting, recordkeeping and other compliance
requirements of the final rule. i. Compliance requirements. To address
the unreasonable risks that EPA has identified for methylene chloride
in consumer paint and coating removal, EPA is finalizing under section
6 of TSCA regulations that prohibit the manufacture (including import),
processing, and distribution in commerce of methylene chloride for all
consumer paint and coating removal. The prohibition on distribution in
commerce of methylene chloride in paint and coating removal for all
consumer uses includes a prohibition on the distribution of methylene
chloride for paint and coating removal to and by retailers. EPA is also
requiring manufacturers (including importers), processors, and
distributors, except for retailers, of methylene chloride for any use
to provide downstream notification of these requirements and
prohibitions throughout the supply chain via simple modifications to
the SDS; and requiring limited recordkeeping.
ii. Classes of small entities subject to the compliance
requirements. The small entities that are potentially directly
regulated by this rule are small entities that are formulators of paint
and coating removal products that contain methylene chloride.
iii. Professional skills needed to comply. For this rule, complying
with the prohibitions, the downstream notification, and the
recordkeeping requirements involve no special skills.
6. Steps taken to minimize economic impact to small entities. i.
Small Business Advocacy Review Panel. As required by section 609(b) of
the RFA, EPA also convened an SBAR Panel during the development of the
proposed rule to obtain advice and recommendations from small entity
representatives that potentially would be subject to the rule's
requirements. The SBAR Panel evaluated the assembled materials and
small-entity comments on issues related to elements of an IRFA. A copy
of the full SBAR Panel Report (Ref. 14) is available in the rulemaking
docket. The Panel recommended that EPA seek additional information in
five specific areas: Exposure information, regulatory options,
alternatives, cost information, and risk assessment. The comments
received on the proposed rule and EPA's responses as they pertain to
consumer paint and coating removal are summarized in Unit II.B.3 and in
further detail in the Response to Comments Document in the docket (Ref.
15).
ii. Alternatives considered. EPA considered a wide variety of risk
reduction options. The primary alternative regulatory action would not
include restrictions on manufacturing, processing, or distribution of
methylene chloride for consumer paint and coating
[[Page 11434]]
removal, but it would require the distribution in commerce of methylene
chloride for paint and coating removal in containers with volumes no
less than 55 gallons, or 5 gallons for certain formulations. In
addition, downstream notification and recordkeeping would be required.
As required under TSCA section 6(c), EPA analyzed the costs and
benefits of the alternative regulatory action (Ref. 4). EPA finds that
the primary alternative regulatory action would introduce additional
burdens to processors and distributors who would bear the costs of
ensuring products are in 55 and 5-gallon containers, as appropriate. In
addition, the 55-gallon volume restriction would effectively bar most
commercial users in the professional contractor, bathtub refinishing,
and graffiti removal sectors given the increased cost. The final rule
is more cost effective than the primary alternative regulatory action
considered. A summary of the findings of this analysis are in III.A.3
and in the Economic Analysis (Ref. 4).
7. Small Business Compliance Guides. EPA is preparing a Small
Entity Compliance Guide to help small entities comply with this rule.
EPA expects that this guide will be made available on the EPA website
prior to the effective date of this final rule.
E. Unfunded Mandates Reform Act (UMRA)
This action does not contain an unfunded mandate of $100 million or
more as described in UMRA, 2 U.S.C. 1531-1538, and does not
significantly or uniquely affect small governments. The requirements of
this action would primarily affect manufacturers, processors, and
distributors of methylene chloride. The total estimated annualized cost
of this final rule are $3.8 to $13.6 million and $3.8 to $13.7 million
annualized over 20 years at 3% and 7%, respectively (Ref. 4), which
does not exceed the inflation-adjusted unfunded mandate threshold of
$154 million.
F. Executive Order 13132: Federalism
EPA has concluded that this action does not have federalism
implications, as specified in Executive Order 13132 (64 FR 43255,
August 10, 1999). This regulation will not preempt state law. It will
not have substantial direct effects on the states, on the relationship
between the national government and the states, or on the distribution
of power and responsibilities among the various levels of government.
Neither pause preemption nor permanent preemption apply to the
restrictions proposed or to this final regulation, because this TSCA
section 6(a) rule is promulgated under TSCA section 26(l)(4). In
accordance with section 26(l)(4), this rulemaking is consistent with
the scope of the 2014 risk assessment of methylene chloride for paint
and coating removal, as well as other applicable requirements of TSCA
section 6, and is not based on a risk evaluation conducted under TSCA
section 6(b). Therefore, EPA believes that this rule will not preempt a
state law or action on methylene chloride for consumer paint and
coating removal under either section 18(a)(1)(B) (under which the
extent of permanent preemption is ``consistent with the scope of the
risk evaluation under section (6)(b)(4)(D)'') or section 18(b) (under
which the extent of pause preemption is tied to the ``scope of the risk
evaluation pursuant to section 6(b)(4)(D)'').
Although this rule does not have federalism implications, the
Agency consulted with state and local officials early in the process of
developing the proposed action to permit them to have meaningful and
timely input into its development. EPA invited the following national
organizations representing state and local elected officials to a
meeting on May 13, 2015, in Washington DC: National Governors
Association; National Conference of State Legislatures, Council of
State Governments, National League of Cities, U.S. Conference of
Mayors, National Association of Counties, International City/County
Management Association, National Association of Towns and Townships,
County Executives of America, and Environmental Council of States. A
summary of the meeting with these organizations, including the views
that they expressed, is available in the docket (Ref. 33).
G. Executive Order 13175: Consultation and Coordination With Indian
Tribal Governments
This action does not have tribal implications, as specified in
Executive Order 13175 (65 FR 67249, November 9, 2000). This rulemaking
would not have substantial direct effects on tribal government because
methylene chloride is not manufactured, processed, or distributed in
commerce by tribes. EPA did not receive any information during the
public comment period to alter EPA's understanding that this action has
no substantial direct effects on tribal governments. Tribes do not
regulate methylene chloride, and this rulemaking would not impose
substantial direct compliance costs on tribal governments. Thus, E.O.
13175 does not apply to this action. EPA nevertheless consulted with
tribal officials during the development of this action, consistent with
the EPA Policy on Consultation and Coordination with Indian Tribes
(Ref. 34).
H. Executive Order 13045: Protection of Children From Environmental
Health Risks and Safety Risks
This action is not subject to Executive Order 13045 (62 FR 19885,
April 23, 1997) because it is not economically significant as defined
in Executive Order 12866, and because EPA does not believe the
environmental health or safety risks addressed by this action present a
disproportionate risk to children. This action's health and risk
assessment of exposure by children to methylene chloride in paint and
coating removal is contained in the proposed rule (Ref. 3 at pp. 7462,
7476, and 7503). Supporting information on methylene chloride exposures
and the health effects of methylene chloride exposure by children is
available in the Toxicological Review of Methylene Chloride (Ref. 5)
and the methylene chloride risk assessment (Ref. 2).
I. Executive Order 13211: Actions Concerning Regulations That
Significantly Affect Energy Supply, Distribution in Commerce, or Use
This final rule is not subject to Executive Order 13211 (66 FR
28355, May 22, 2001), because this action is not expected to affect
energy supply, distribution in commerce, or use. This rule is intended
to protect against risks from methylene chloride in paint and coating
removal, and does not affect the use of oil, coal, or electricity.
J. National Technology Transfer and Advancement Act (NTTAA)
This final rule does not involve technical standards, and is
therefore not subject to considerations under NTTAA section 12(d), 15
U.S.C. 272.
K. Executive Order 12898: Federal Actions To Address Environmental
Justice in Minority Populations and Low-Income Populations
Executive Order 12898 (59 FR 7629, February 16, 1994) establishes
Federal executive policy on environmental justice. Its main provision
directs Federal agencies, to the greatest extent practicable and
permitted by law, to make environmental justice part of their mission
by identifying and addressing, as appropriate, disproportionately high
and adverse health or environmental effects of their programs, policies
and activities on minority populations and low-income populations in
the U.S. EPA places particular emphasis on the public
[[Page 11435]]
health and environmental conditions affecting minority populations,
low-income populations, and indigenous peoples. In recognizing that
these populations frequently bear a disproportionate burden of
environmental harms and risks, EPA works to protect them from adverse
public health and environmental effects (Ref. 35).
L. Congressional Review Act (CRA)
This action is subject to the CRA, and the EPA will submit a rule
report to each House of the Congress and to the Comptroller General of
the United States. This action is not a ``major rule'' as defined by 5
U.S.C. 804(2).
List of Subjects in 40 CFR Part 751
Environmental protection, Chemicals, Export notification, Hazardous
substances, Import certification, Reporting and recordkeeping
requirements.
Dated: March 15, 2019.
Andrew Wheeler,
Administrator.
0
Therefore, add 40 CFR part 751 to read as follows:
PART 751--REGULATION OF CERTAIN CHEMICAL SUBSTANCES AND MIXTURES
UNDER SECTION 6 OF THE TOXIC SUBSTANCES CONTROL ACT
Subpart A--General Provisions
Sec.
751.1 Purpose.
751.5 Definitions.
751.7 Exports and imports.
751.9 Enforcement and inspections.
Subpart B--Methylene Chloride
751.101 General.
751.103 Definitions.
751.105 Consumer paint and coating removal.
751.107 Downstream notification.
751.109 Recordkeeping.
Subpart C--[Reserved]
Authority: 15 U.S.C. 2605, 15 U.S.C. 2625(l)(4).
Subpart A--General Provisions
Sec. 751.1 Purpose.
This part sets forth requirements under section 6(a) of the Toxic
Substances Control Act, 15 U.S.C. 2605(a), regulating the manufacture
(including import), processing, distribution in commerce, use, or
disposal of certain chemical substances and mixtures in order to
address unreasonable risks to the extent necessary so that the chemical
substance or mixture no longer presents such risk.
Sec. 751.5 Definitions.
The definitions in section 3 of the Toxic Substances Control Act,
15 U.S.C. 2602, apply to this part except as otherwise established in
any subpart under this part.
Act or TSCA means the Toxic Substances Control Act, 15 U.S.C. 2601
et seq.
CASRN means Chemical Abstracts Service Registry Number.
EPA means the U.S. Environmental Protection Agency.
Person means any natural person, firm, company, corporation, joint
venture, partnership, sole proprietorship, association, or any other
business entity; any State or political subdivision thereof; any
municipality; any interstate body; and any department, agency, or
instrumentality of the Federal government.
Sec. 751.7 Exports and imports.
(a) Exports. Persons who intend to export a chemical substance
identified in any subpart under this part are subject to the export
notification provisions of section 12(b) of the Act. The regulations
that interpret section 12(b) appear at 40 CFR part 707, subpart D.
(b) Imports. Persons who import a substance identified in any
subpart under this part are subject to the import certification
requirements under section 13 of the Act, which are codified at 19 CFR
12.118 through 12.127. See also 19 CFR 127.28.
Sec. 751.9 Enforcement and inspections.
(a) Enforcement. (1) Failure to comply with any provision of this
part is a violation of section 15 of the Act (15 U.S.C. 2614).
(2) Failure or refusal to establish and maintain records or to
permit access to or copying of records, as required by the Act, is a
violation of section 15 of the Act (15 U.S.C. 2614).
(3) Failure or refusal to permit entry or inspection as required by
section 11 of the Act (15 U.S.C. 2610) is a violation of section 15 of
the Act (15 U.S.C. 2614).
(4) Violators may be subject to the civil and criminal penalties in
section 16 of the Act (15 U.S.C. 2615) for each violation.
(b) Inspections. EPA may conduct inspections under section 11 of
the Act (15 U.S.C. 2610) to ensure compliance with this part.
Subpart B--Methylene Chloride
Sec. 751.101 General.
This subpart sets certain restrictions on the manufacture
(including import), processing, and distribution in commerce of
methylene chloride (CASRN 75-09-2) for consumer paint and coating
removal to prevent unreasonable risks of injury to health due to acute
human lethality.
Sec. 751.103 Definitions.
The definitions in subpart A of this part apply to this subpart
unless otherwise specified in this section. In addition, the following
definitions apply:
Consumer paint and coating removal means paint and coating removal
performed by any natural person who uses a paint and coating removal
product for any personal use without receiving remuneration or other
form of payment.
Distribute in commerce has the same meaning as in section 3 of the
Act, except that the term does not include retailers for purposes of
Sec. Sec. 751.107 and 751.109.
Paint and coating removal means application of a chemical or use of
another method to remove, loosen, or deteriorate any paint, varnish,
lacquer, graffiti, surface protectants, or other coating from a
substrate, including objects, vehicles, architectural features, or
structures.
Retailer means a person who distributes in commerce or makes
available a chemical substance or mixture to consumer end users,
including e-commerce internet sales or distribution. Any distributor
with at least one consumer end user customer is considered a retailer.
A person who distributes in commerce or makes available a chemical
substance or mixture solely to commercial or industrial end users or
solely to commercial or industrial businesses is not considered a
retailer.
Sec. 751.105 Consumer paint and coating removal.
(a) After November 22, 2019, all persons are prohibited from
manufacturing, processing and distributing in commerce methylene
chloride for consumer paint and coating removal.
(b) After November 22, 2019, all persons are prohibited from
distributing in commerce methylene chloride, including any methylene
chloride containing products, for paint and coating removal to
retailers.
(c) After November 22, 2019, all retailers are prohibited from
distributing in commerce methylene chloride, including any methylene
chloride containing products, for paint and coating removal.
[[Page 11436]]
Sec. 751.107 Downstream notification.
Each person who manufactures, processes, or distributes in commerce
methylene chloride for any use after August 26, 2019 must, prior to or
concurrent with the shipment, notify companies to whom methylene
chloride is shipped, in writing, of the restrictions described in this
subpart. Notification must occur by inserting the following text in the
Safety Data Sheet (SDS) provided with the methylene chloride or with
any methylene chloride containing product:
(a) SDS Section 1.(c): ``This chemical/product is not and cannot be
distributed in commerce (as defined in TSCA section 3(5)) or processed
(as defined in TSCA section 3(13)) for consumer paint or coating
removal.''
(b) SDS Section 15: ``This chemical/product is not and cannot be
distributed in commerce (as defined in TSCA section 3(5)) or processed
(as defined in TSCA section 3(13)) for consumer paint or coating
removal.''
Sec. 751.109 Recordkeeping.
(a) Each person who manufactures, processes, or distributes in
commerce any methylene chloride after August 26, 2019 must retain in
one location at the headquarters of the company, or at the facility for
which the records were generated, documentation showing:
(1) The name, address, contact, and telephone number of companies
to whom methylene chloride was shipped;
(2) A copy of the notification provided under Sec. 751.107; and
(3) The amount of methylene chloride shipped.
(b) The documentation in paragraph (a) of this section must be
retained for 3 years from the date of shipment.
Subpart C--[Reserved]
[FR Doc. 2019-05666 Filed 3-26-19; 8:45 am]
BILLING CODE 6560-50-P