Regulatory Update
July 2017 www.coatingsworld.com Coatings World | 105
With regard to DCM in paint stripping, EPA went even further, proposing to restrict sales to 55-gallon drums in order to
reduce consumer exposure. This would eliminate sale of DCM-based paint strippers to consumers at Lowe’s and Home Depot
and decimate the commercial refinishing market as well. Here
EPA proposed to act without reference to the Federal Hazardous
Substances Act, pursuant to which the Consumer Product Safety
Commission (CPSC) has issued a Statement of Enforcement
Policy that specifies uniform cautionary labelling for all household products containing methylene chloride. Further, in June
2017 the CPSC announced that it will be revising the Statement
of Enforcement Policy to strengthen the labelling requirements.
TSCA § 9
As originally enacted, and updated by the Lautenberg Act, TSCA §
9 requires EPA to consult and coordinate with other federal agencies “for the purpose of achieving the maximum enforcement of this
Act, while imposing the least burdens of duplicative requirements.”
It was clear from the outset that TSCA is to be used only
when other statutes fail to provide a remedy for unreasonable
risks. When TSCA was enacted in 1976, Representative James
Broyhill of North Carolina indicated that “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” (122
Cong. Rec. H11344 (Sept. 28, 1976)). TSCA Section 9(a) is substantively unchanged by the Lautenberg Act. The House Energy
and Commerce Committee Report states: “H.R. 2576 reinforces
TSCA’s original purpose of filling gaps in Federal law that otherwise did not protect against the unreasonable risks presented by
chemicals,” and further clarifies that “while Section 5 makes no
amendment to TSCA Section 9(a), the Committee believes that
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”
(H. Rep. No. 114-176 (114th Cong., 1st Sess.) at 28).
Colloquies on the floor of the House of Representatives
make this intent clear with specific reference to TCE and DCM.
Taking steps that may lead to the removal of products from the
marketplace, because workers or consumers failed to comply
with the existing legal requirements, is not consistent with the
original or revised version of TSCA.
New Science Requirements -- TSCA §§ 6, 26
EPA proposed to expand its authority into the workplace and
consumer uses even though TSCA § 9’s limits on this authority were strengthened. On the other hand, although significant
changes were made to ensure that EPA would employ the “best
available science” in its risk assessments, the EPA proposals rely
on remarkably sketchy and inadequate assessments.
The substantive “best available science” requirements of TSCA §§
6 and 26 include making decisions based on the weight of the scientific
evidence, taking into account peer review, and the like. Following enactment of the Lautenberg Act, it should be clear that a risk evaluation
that supports a TSCA § 6 rule must be more robust than the screening
level assessments that EPA conducted for TCE and DCM in 2014.
The numerous scientific deficiencies identified by peer review
and public comments include:
• the inappropriate use of default assumptions;
• ignoring contrary evidence or “cherry picking,” instead of
basing conclusions on the weight of the scientific evidence;
• reliance on inapposite exposure data;
• conclusions inconsistent with the evidence cited; and
• reliance on a study that is not reproducible.
Implications for Other Chemicals
There is nothing unique or unusual about TCE or DCM that
would limit EPA’s over-reaching to their uses. EPA initially targeted them because of concerns about consumers and small
workplaces, but is now looking at much broader regulation.
EPA has derived cancer potency factors for dozens of widely
used compounds. Most if not all such substances would effectively be banned from the workplace and consumer products
if the approach reflected in the proposed bans were adopted.
For example, the AEL for vinyl chloride using EPA’s approach
would be 0.7 ppb, for formaldehyde 0.5 ppb, in each case some
1500 times or more lower than the OSHA PEL.
Going forward, it is important that new approaches to the
accepted EPA methodology for cancer risk assessment be developed. This methodology is based on models developed to assess
cancer risk from ionizing radiation. Under this linearized non-threshold model, radiation is always considered harmful, there
is no safe exposure, and biological damage caused by ionizing
radiation (essentially the cancer risk) is directly proportional to
the amount of radiation exposure to the human body (response
linearity). The scientific basis for applying these assumptions to
low-level radiation is under review by the Nuclear Regulatory
Commission ( 80 Fed. Reg. 35870 (June 23, 2015), and consideration of the direct applicability of this approach to low-dose
chemical carcinogenesis is long overdue. More narrowly, the
circumstances in which non-linear or threshold mechanisms
may account for increased cancer incidence in high-dose cancer
bioassays, and species differences in metabolism and pharma-cokinetics, need to be carefully evaluated and, where relevant,
taken into account in EPA’s cancer risk assessments. CW
W. Caffey Norman is a partner in the Washington DC office of
Squire Patton Boggs. Caffey’s environmental practice focuses
on the regulation of hazardous chemicals by the Environmental
Protection Agency, the Occupational Safety and Health
Administration, the Consumer Product Safety Commission, and
various state regulatory agencies. He has been particularly active
in the subject areas of toxic substances, stratospheric ozone depletion, and global warming. For many years Caffey has developed
and successfully implemented strategies to defend products targeted for phase out or use reduction. He has participated in EPA
rulemakings to regulate hazardous substances under all the environmental statutes and has initiated legislative and judicial review
of a number of EPA regulations. Caffey also represents a number
of industry task forces in connection with pesticide registration
and the negotiation of test rules and testing consent orders.
