Introduction
• Proposed rule addresses paint stripping with methylene
chloride (dichloromethane or DCM).
• Will be in first round of rulemaking under TSCA § 6 since
1989, among first rules to interpret “unreasonable risk”
under revised TSCA.
• SBAR meeting held June 15, 2016; EPA disclosed intent
to take over regulation of DCM in workplace/consumer
applications.
• Clearly raises novel legal or policy issues arising out of
legal mandates for purposes of E.O 12866.

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 Applicable TSCA § 6 Requirements
 TSCA § 6(c)(2)(C) – in adopting a specific condition of use EPA must
consider whether “technically and economically feasible alternatives”
that benefit health or the environment, compared to use to be
restricted, will be “reasonably available as a substitute when the
proposed prohibition or other restriction takes effect.”
 Given the information EPA has received from the small businesses
that rely on and use this chemical, it is clear that a true substitute is
not available at this time (and presumably will not be “reasonably
available as a substitute when the proposed prohibition or other
restriction takes effect”).
 TSCA § 26(l)(4) – where risk assessment completed prior to date of
enactment, § 6(a) rule must be consistent with “the scope of the
completed risk assessment for the chemical substance and
consistent with other applicable requirements of § 6.”

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 TSCA § 6 Requirements for Risk Assessments
 Under TSCA § 6(b)(4)(F) the risk evaluation must:
• “integrate and assess available information on hazards
and exposures for the conditions of use of the chemical
substance, including information that is relevant to specific
risks of injury to health or the environment . . .;”
• “take into account, where relevant, the likely duration,
intensity, frequency, and number of exposures under the
conditions of use of the chemical substance;” and
• “describe the weight of the scientific evidence for the
identified hazard and exposure.”

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 TSCA § 6 Requirements, cont.
§ 26(h): “In carrying out sections 4, 5, and 6, to the extent that the Administrator makes a decision
based on science, the Administrator shall use scientific information, technical procedures, measures,
methods, protocols, methodologies, or models, employed in a manner consistent with the best
available science, and shall consider as applicable—
 (1) the extent to which the scientific information, technical procedures, measures, methods,
protocols, methodologies, or models employed to generate the information are reasonable for and
consistent with the intended use of the information;
 (2) the extent to which the information is relevant for the Administrator’s use in making a decision
about a chemical substance or mixture;
 (3) the degree of clarity and completeness with which the data, assumptions, methods, quality
assurance, and analyses employed to generate the information are documented;
 (4) the extent to which the variability and uncertainty in the information, or in the procedures,
measures, methods, protocols, methodologies, or models, are evaluated and characterized; and
 (5) the extent of independent verification or peer review of the information or of the procedures,
measures, methods, protocols, methodologies, or models.”
§ 26(i): “The Administrator shall make decisions under sections 4, 5, and 6 based on the weight of
the scientific evidence.”
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 Cancer Hazard Assessment
 Characterization of DCM as “likely carcinogenic in humans” based entirely on
IRIS Assessment, but no discussion of concerns raised by HSIA and other
commenters.
 IRIS Assessment, like the IARC classification, used a “strength of the
evidence” approach; TSCA § 26(i) requires “decisions under sections 4, 5,
and 6 [to be] based on the weight of the scientific evidence.”
 Characterization ignores robust data base of five occupational cohort studies,
including an exhaustive study of Eastman Kodak employees: “In summary,
the Kodak research was well designed, thoughtfully conducted, and
appropriately expanded over time. Findings were consistently negative for
causes of death hypothesized to be related to methylene chloride exposure,
such as ischemic heart disease and cancers of the lung and liver, as well as
for any other specific cause of death.” Dell et al. (1999).
 The epi studies also do not support an association between DCM and brain
cancer. A recent comprehensive study found no association between
exposure to DCM and glioma risk. Ruder et al. (2014).
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 Noncancer Hazard Assessment
 Acute risk based on bathtub refinishing scenario, which was initial focus of
EPA concern. There have been 14 deaths associated with asphyxiation from
use of DCM refinishing bathtubs in spaces with little or no ventilation.
 Risk is being addressed by Consumer Product Safety Commission (CPSC),
which has invited comment on a petition submitted by HSIA, 81 Fed. Reg.
60298 (Sept. 1, 2016).
 HSIA’s petition asks the Commission to expand its 1987 Statement of
Interpretation and Enforcement Policy regarding labeling of household
products containing DCM, so that it addresses acute hazard as well as the
chronic hazard already addressed. The label submitted by HSIA went
beyond precautionary language and stated “Do Not Use To Strip Bathtubs,”
with a corresponding pictogram.
 CPSC staff has already approved the expanded cautionary language, which
formulators are using.
 Under the Federal Hazardous Substances Act, further regulation of these
household products is precluded absent a finding that the cautionary
language contained in the Commission’s Statement is ineffective.
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 Exposure Assessment
 Work Plan Assessment relies on incorrect baseline for exposure to DCM from
paint stripping, particularly the occupational exposure scenarios.
Inadequacies described in draft Assessment include:
 “The principal limitation of the worker exposure data is the uncertainty in
the representativeness of the data. EPA reviewed a number of published
exposure studies with inherent data limitations including: number of
facilities, job sites, or residences; most often, limited number of sites
investigated.”
 “An additional data limitation for occupational exposure estimation is the
age of the identified exposure studies. Most of the exposure studies were
conducted in the 1990s, with some pre-dating the 1990s; some studies
were more recent. Some references have discussed a trend to reduce the
use of DCM in paint stripping products (i.e., OSHA promulgated new
exposure limits for DCM in 1997). These factors can limit the
representativeness of 1990 and older data with regards to present day
workplace conditions and exposures.”

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 Exposure Assessment, cont.
 It is remarkable that EPA would even consider using pre-1997 exposure data
in an assessment of occupational exposures to DCM.
 In that year OSHA adopted a standard under § 6(b)(5) of the Occupational
Safety and Health Act lowering the workplace exposure limit for DCM from
500 parts per million (ppm) to 25 ppm as an 8-hour time-weighted average
(TWA), a 95% reduction.
 The statement “it is not known, but it is possible, that actual exposure
distributions could be declining during the monitoring period considered in
this assessment” is puzzling, considering that entire applications of DCM
were lost as a result of the lower workplace limit,
 In sum, where DCM continues to be used, including in paint stripping,
exposures must be kept below 12.5 ppm to avoid triggering the action level.
There is no basis for EPA to assume that DCM is being used throughout the
United States in what would be flagrant violation of the OSHA standard.

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 Exposure Assessment, cont.
 NESHAP for Paint Stripping and Miscellaneous Surface Coating Operations
at Area Sources, 40 C.F.R. Part 63, Subpart HHHHHH, requires paint
stripping operations using DCM to:
 Institute management practices to (i) ensure there is a need for paint
stripping; (ii) ensure there is no alternative paint stripping technology that
can be used; (iii) reduce inhalation exposure from paint strippers; (iv)
optimize application conditions to reduce DCM evaporation; and (v)
practice proper storage and disposal of paint strippers
 Develop and implement a written plan to minimize the use and emissions
of DCM (if facility uses more than one ton of DCM annually)
 Maintain copies of annual usage of DCM paint strippers on site at all times
 Maintain a copy of current DCM minimization plan on site at all times (if
facility uses more than one ton of DCM annually)

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 Exposure Assessment, cont.
 The exposure data in the assessment predate the compliance dates
of the NESHAP (ranging from January 2008 to January 2011). Most
significantly, the assessment seems to have been conducted without
reference to the extensive reporting and recordkeeping requirements
of the NESHAP.
 Under the NESHAP, every facility must make initial notification and
report annually to EPA the location of each paint stripping operation,
identifying the method employed and substrates stripped, whether
the source is in compliance, and whether it plans to use more than
one ton of DCM post-compliance.
 Even more extensive information on DCM content and usage are
required to be maintained by the operator and accessible to EPA.
 It is remarkable that the Work Plan assessment was apparently
compiled without utilizing the data already in the hands of EPA and
other permitting authorities.
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 Screening Level Assessment

 The Assessment uses a screening level modeling
approach to assess hazard and exposure.
 This does not meet OMB Information Quality Act
guidelines for a ‘‘highly influential scientific
assessment’’ to support TSCA § 6 rulemaking.
Screening level assessments are considered
inappropriate to support regulations intended to
reduce risk because they do not accurately
estimate risk or quantify exposures.

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 TSCA Requirements/DCM Assessment
 Take into account exposure under
the conditions of use
 Describe weight of the scientific
evidence for identified hazard and
exposure
 Use of scientific information,
employed in a manner consistent
with the best available science
 Consider variability and uncertainty
in the information
 Consider extent of independent
verification or peer review of the
information

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 Screening level assessment
 Hazard assessment based on
“strength of evidence” as opposed
to “weight of evidence”
 Exposure assessment based on
workplace limits in effect 20 years
ago that are 20 times higher than
current limits, and ignores available
EPA data
 No formal or informal uncertainty
analysis

12

  

Acceptable Exposure Limit (AEL):
Methylene chloride

Existing chemical acceptable exposure limit (AEL) is:

- Derived from the lowest risk estimate and appropriate UF to provide margin of safety

- Calculated for acute and chronic exposures and non-cancer and cancer effects

- Selected to be protective of all risks (for methylene chloride this is based on cancer risk)

Non-cancer
POD(acute or Chronic)

0E benchmark (acute or Chronic)

 

Duration Adjustment

AELWWcancers for acute exposures 1.3 
for chronic exposures 2 

 

 

Cancer
Cancer benchmark(10'5) Lifetime(24-hrs 365duys 70 yrs)
AEL 0.2 
cancer I UR Working Career(8hrsX 250days 40 yrs) pp

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Exposure Estimates: Methylene Chloride
Industry

Acceptable
exposure limit
(8 hr TWA,
ppm)

Acute highend estimated
exposure
(8 hr TWA,
ppm)

Chronic high-end
estimated
exposure
(8 hr TWA ppm)

Professional Contractors

0.2

858

431

Automotive Refinishing

0.2

120

64

Furniture Refinishing

0.2

364

169

Aircraft Paint Stripping

0.2

1,095

551

Graffiti Removal

0.2

342

139

Other workplace settings
(immersion stripping)

0.2

2,015

1009

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 EPA’s Authority to Regulate Occupational Risks
• SERs were interested in more information about EPA’s authority to
regulate occupational hazards and risks, compared to OSHA
• OSHA authority extends only to private sector employers
– Public sector employees conducting paint removal are not subject to OSHA

• TSCA restrictions are consistent with OSHA hierarchy of hazard
control (eliminate/substitute hazard; engineering controls; best
practices administrative controls; personal protective equipment)
• TSCA authority can address the risks form methylene chloride and
NMP in paint removal that cut across worker, public sector and
consumer settings
• EPA is working closely with OSHA; both agencies feel TSCA is the
appropriate authority to address the risks that EPA has identified,
including those that occur in workplaces
– See letter of support from Department of Labor in Appendix E
15

 OSHA Letter
 “OSHA lacks direct jurisdiction over state and local
government workers.”
 “OSHA does not cover self-employed workers, military
personnel and uniquely military equipment, systems, and
operations, and workers whose occupational safety and
health hazards are regulated by another federal agency.”
 “[S]ince 1976, there has been an annual rider to OSHA's
appropriation that prohibits the agency from expending
appropriated funds to issue standards for or conduct
enforcement activities against certain small farming
operations.”

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 Potential Regulatory Options - Methylene Chloride
1.
2.
•

Regulatory Option #1: Prohibit manufacturing, distribution, and use of methylene
chloride as a paint remover
Regulatory Option #2: Allow certain commercial uses with worker protections and
other requirements to protect the public
Worker protections: Personal protective equipment (PPE) or air exposure limit
–

PPE:
•
•
•

–

As an alternative, work places could meet an air exposure limit of 0.2 ppm
•

•

APF 1,000 would be in most scenarios, with APF 10,000 when immersion methods of paint removal are
used. APF is the workplace level of respiratory protection that a respirator or class of respirators is
expected to provide to employees.
A respiratory protection program includes training, medical monitoring, re-fitting, and other components
of respirator protection programs
Workers nearby (occupational bystanders) would be required to wear respirators as well, or be
excluded from the area
Potentially could use engineering controls such as ventilation to reduce the respirator APF needed

Other requirements:
–
–
–

Downstream notification by manufacturers, processors, and distributors of the prohibitions for
this use
Packaging of paint removers containing methylene chloride in volumes no less than
55-gallon drums
Bystanders (such as residents of homes) must stay out for up to 24 hours after work is
completed

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 Legal Authority – TSCA § 9
 § 9(a) – Laws not administered by EPA:
If unreasonable risk can be sufficiently reduced under a law not administered by
EPA, EPA shall publish and submit to the other agency a report and request it to
determine if it can reduce the risk under such other law. The other agency must
respond to EPA and publish its response.
 Other agency must either decide that there is no such risk or initiate rulemaking
within 90 days of its response


 § 9(b) – Laws administered by EPA:
If risk can be sufficiently reduced under another law administered by EPA, then EPA
must use that other authority unless it determines that it is in the public interest to
proceed under TSCA.
 In making public interest determination, EPA must compare the estimated costs and
efficiencies of the actions to be taken under TSCA and action to be taken under
such other law.


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 Occupational and Consumer Regulation
• In 1985 EPA initiated a priority review of risks of cancer from DCM, using its
authority under TSCA § 4(f), and made referrals to OSHA and the CPSC,
under whose jurisdictions fall worker and consumer health and safety,
respectively.
• This comprehensive regulatory framework provides adequate protections
with respect to the same potential adverse impacts and potential exposure
pathways targeted by the current EPA initiative. Taking action that would lead
to the removal of products from the marketplace on the false assumption
that workers and consumers fail to comply with existing requirements is not
consistent with TSCA as initially enacted or as revised.
• As noted above, OSHA has regulated occupational exposure to DCM for
many years. Following the § 4(f) review, OSHA adopted a standard lowering
the workplace exposure limit for DCM from 500 ppm to 25 ppm.
• Under the Federal Hazardous Substances Act, further regulation of DCMbased household products is precluded absent a finding that the cautionary
language contained in the Commission’s Policy Statement is ineffective.
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 Legislative History
 Original history is clear: “it was the intent of the conferees that the Toxic
Substance [Control] Act not be used, when another act is sufficient to
regulate a particular risk.”
 Recent House report: “TSCA's original purpose [is] filling gaps in Federal law
that otherwise did not protect against the unreasonable risks presented by
chemicals,” and “the Administrator should respect the experience of, and
defer to other agencies that have relevant responsibility such as the
Department of Labor in cases involving occupational safety.” Colloquy:
 “Mrs. BLACKBURN. It is my understanding that, as a unified whole, this language, old and new,
limits the EPA's ability to promulgate a rule under § 6 of TSCA to restrict or eliminate the use of a
chemical when the Agency either already regulates that chemical through a different statute under
its own control and that authority sufficiently protects against a risk of injury to human health or the
environment, or a different agency already regulates that chemical in a manner that also
sufficiently protects against the risk identified by EPA. Would the chairman please confirm my
understanding of § 9?
 “Mr. SHIMKUS. The gentlewoman is correct in her understanding.
 “Mrs. BLACKBURN. As the EPA's early-stage efforts to regulate methylene chloride and TCE
under TSCA § 6 illustrate, they are also timely. EPA simply has to account for why a new regulation
for methylene chloride and TCE under TSCA is necessary. . . .”
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 Environmental Regulation
 As already noted, under the Clean Air Act EPA has adopted
regulations for DCM in paint stripping that protect public health
with an ample margin of safety.
 Strangely, the Assessment appears to have been conducted
without reference to the NESHAP, resulting in great uncertainty
in its estimates of DCM releases, exposures, and population
exposed, all of which could be eliminated by using data
required to be reported to EPA under the NESHAP.
 Has EPA compared the estimated costs and efficiencies of the
actions to be taken under TSCA against the NESHAP or any
action that might be taken to strengthen the NESHAP?

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 Conclusion
OMB should not clear proposed rule:
 Assessment does not comply with TSCA §§ 6, 26:
 Not best available science or based on weight of
scientific evidence
 Screening level hazard/exposure assessments
 Exposure assessment greatly overstates exposure/risk
 No justification for usurping OSHA authority over
workplace and CPSC jurisdiction over consumer
products, or ignoring existing EPA regulation of same
sources

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