An Opportunity Squandered With Total Impunity
| Author | Penelope Fenner-Crisp |
| Position | Independent consultant working with the Environmental Protection Network. She is a former division director in EPA's Office of Pollution Prevention and Toxics |
| Pages | 56-56 |
56 Reprinted by permission from The Environmental Forum®, May/June 2021.
Copyright © 2021, Environmental Law Institute®, Washington, D.C. www.eli.org.
THE DEBATE
sented an unreasonable risk.
e Environmental Protection
Network (and many others) submit-
ted comments on these drafts, as did
the agency’s own external Science
Advisory Committee on Chemicals.
ese comments identied missing
and awed information and analysis.
Among the most signicant blun-
ders was the use of an unvetted, ill-
conceived systematic review process
for study identication, selection,
grading, and evaluation.
e draft risk evaluations excluded
some existing and all legacy conditions
of use from evaluation. EPA failed to
employ Section 4 of the law to require
chemical sponsors to ll critical data
gaps. Furthermore, the agency did
not account for these data deciencies
when deriving benchmark margins of
exposure, a key metric in the determi-
nation of unreasonable risk.
Other deciencies led to underesti-
mation of risks to workers, consumers,
and bystanders. e agency refused
to incorporate ambient environmen-
tal exposures into the consumer/
bystander evaluations or to aggregate
inhalation, dermal, and oral exposures
in any evaluation. EPA further relied
on misguided assumptions in its occu-
pational risk determinations, claiming
workers would use personal protective
equipment. But the agency had little
assurance that companies provide PPE
routinely to workers, that the equip-
ment ts properly, and that it was
worn throughout the work shift.
Finally, not all risk evaluations in-
cluded detailed, specic ndings for
susceptible or higher-risk subpopula-
tions (e.g., children, pregnant women,
those with signicant health condi-
tions), as mandated in the law.
In a nal act of disregard, the
Trump EPA scheduled the scientic
peer reviews of the draft evaluations
during, rather than after, the public
review and comment period. is de-
prived the SACC’s independent expert
reviewers of valuable insights for their
consideration.
e nal risk evaluations for the 10
chemicals were released in late 2020
and early January 2021. But the agen-
cy repaired none of the aws in re-
sponse to public input. Furthermore,
it pursued no risk mitigation measures
in which the agency identied sig-
nicant acute risks of concern. EPA
brushed o requests to immediately
propose and promulgate rules under
Section 6(a) and use its authority
under Section 6(d) to expedite their
eective dates.
To add insult to injury, rules pro-
posed on three chemicals prior to
January 2017 gathered dust for four
years, only to be wiped o the agency’s
regulatory agenda in late December
2020, forcing EPA to start the rule-
making process all over again.
So, how can the agency rectify this
ignominious implementation of the
new TSCA program for existing chem-
icals? e good news is that the Biden
administration has already expressed its
commitment to review and overhaul
it. I believe it can be done without
having to revise the rules that govern
prioritization and risk evaluation. e
Ninth Circuit has held that exclusion
of legacy uses and associated disposal
contradicts TSCA’s plain language and,
therefore, they will be evaluated.
e recent report from the Na-
tional Academy of Sciences made it
clear that the systematic review guid-
ance requires signicant modication
and consistency of approach across the
agency. In a recent letter to EPA, the
Environmental Protection Network
recommended a path forward, using
Section 4 of the law, to ll critical data
gaps without compromising mandat-
ed timelines. Proper coordination of
peer review and public comment can
occur through better planning and
time management. e other aws
can be xed by revising internal risk
assessment guidance and practices.
Let’s hope, in the end, that Charlie
Brown’s tree will be reincarnated as a
blue spruce, after all.
and Toxics.
An Opportunity
Squandered With
Total Impunity
The headline above sums up
the Trump administration’s
implementation of the new
Toxic Substances Control
Act. While the law made some
modications to the process for
evaluating new chemicals prior to
their introduction into commerce,
the most signicant changes were to
EPA’s review of existing chemicals.
e new statute streamlines the
process for requesting new data
from the regulated community,
lowering the burden of proof for
identifying potential risk and replac-
ing rulemaking with test orders.
e law creates a three-step process:
priority setting, risk evaluation, and
risk management. e law carefully
separates risk evaluation, which de-
termines whether or not a chemical
poses an “unreasonable risk,” and
risk management. An “unreasonable
risk” nding then obliges the agency
to consider non-risk factors when
selecting risk management options.
So, what grade does the previous
administration earn for implementing
this new existing chemicals program?
In my view, a big, fat “F.” Here’s why.
e rules for prioritization and
risk evaluation were proposed in mid-
January 2017 and nalized after the
Trump administration took oce. By
then, the promise of transformation
into a majestic blue spruce looked
more like Charlie Brown’s woeful
Christmas tree, with drooping branch-
es bereft of needles.
is shift was not immediately
apparent but unfolded as the agency
released draft risk evaluations for the
rst 10 chemicals for review and com-
ment. Detailed scrutiny revealed what
had been stripped from the tree, dis-
closing the agency’s moves to identify
as few scenarios as possible that pre-
To continue reading
Request your trial