W. Caffey Norman, Contributing Writer
EPA last regulated a chemical under Toxic Substances Control Act (TSCA) § 6, which provides for regulation of existing as opposed to new chemicals, in 1989. This 28-
year hiatus may be coming to an end, with the proposal of three
such rules in the month before the inauguration of President
Trump. While the new Administration may never adopt the
proposed rules, the approach to implementing § 6 that they reflect should be of great concern to formulators, chemical manufacturers, and manufacturing industry generally.
Proposed Rules
First, EPA proposed to ban the use of trichloroethylene (TCE) in
aerosol degreasing and in spot cleaning by dry cleaning facilities
( 81 Fed. Reg. 91592 (Dec. 16, 2016)). Thereafter, on the day
before inauguration, EPA proposed to ban use of TCE in vapor
degreasing ( 82 Fed. Reg. 7432 (Jan. 19, 2017) and to ban use of
methylene chloride (dichloromethane or DCM) in paint stripping ( 82 Fed. Reg. 7464 (Jan. 19, 2017).
Each of these rules was proposed under the authority of TSCA
§ 6(a), as amended in June 2016 by the Frank R. Lautenberg
Chemical Safety for the 21st Century Act (“Lautenberg Act”),
based on risk assessments completed in 2014. While EPA is authorized under TSCA § 26(l)( 4) to regulate based on a risk assessment completed before TSCA was revised, the statute is very clear
that any such rule must fall within the scope of the assessment
and that EPA must comply with all “applicable” requirements of
TSCA § 6. Industry commenters have detailed the deficiencies
in these proposals, and recommended that EPA instead consider
these uses as part of mandated risk assessments beginning later
this year for ten priority compounds recently designated by EPA
under TSCA § 6(b)(2)(A), which include TCE and DCM. The
concern is that adoption of these proposals would greatly expand
EPA’s authority and would be inconsistent with the “best available science” requirements of the Lautenberg Act.
Occupational and Consumer Exposure
Surprisingly, the proposed rules focus on occupational and
consumer exposures, long considered to be the province of the
Occupational Safety and Health Administration (OSHA) and
the Consumer Product Safety Commission (CPSC), respectively.
The basis for EPA’s broad assertion of jurisdiction over occupa-
tional and consumer uses is unclear. The Lautenberg Act elimi-
nated the requirement in TSCA § 6(a) that EPA protect “against
[unreasonable] risk using the least bur-
densome requirements,” and included
a new requirement that EPA determine
whether a chemical substance presents
an unreasonable risk of injury to health
or the environment. . . including an un-
reasonable risk to a potentially exposed
or susceptible subpopulation,” defined
to include workers. But the Lautenberg
Act did not materially change the exist-
ing framework that requires unreason-
able risk to be addressed under statutory
authority other than TSCA wherever possible.
Based on the 2014 assessments, EPA identified many oc-
cupational exposure scenarios that exceeded its target cancer
risk range. For TCE, EPA derived an acceptable exposure lim-
it (AEL) of 0.4 parts per billion (ppb) as an eight-hour time-
weighted average (TWA). This is 250,000 times lower than the
current OSHA permissible exposure limit (PEL) of 100 ppm.
For DCM, EPA derived a cancer AEL of 0.2 ppm, over 100
times lower than the 25 ppm limit set by OSHA when it adopted
a comprehensive standard for the substance.
EPA’s asserted justification for this newfound authority to
regulate occupational hazards was that OSHA’s jurisdiction
does not extend to all state and local government employees,
self-employed workers, military personnel and certain other
employees. EPA produced a letter from David Michaels, then
Assistant Secretary for Occupational Safety and Health, to
James Jones, then EPA Assistant Administrator for Chemical
Safety and Pollution Prevention, which stated “[g]iven [these]
limitations imposed on OSHA’s authority under the OSH Act,
this agency believes TSCA provides the EPA with a means of
eliminating or reducing the risks associated with these chemical
uses in a more coordinated fashion, across both consumer and
occupational settings.”
While OSHA’s jurisdiction has been so limited since enact-
ment of the Occupational Safety and Health Act in 1970, which
preceded enactment of TSCA by six years, it had not been previ-
ously suggested that this limitation on OSHA’s authority gives
EPA jurisdiction over hazardous chemicals in the workplace.
Moreover, as these limitations are universally applicable, EPA
would supplant OSHA’s workplace authority over use of all
hazardous chemicals in the workplace.
EPA Implementation of TSCA § 6
Poses Risks for Coatings Industry
W. Caffey Norman