New chemical review process
slows, while states remain active
Regulatory Review is a regular column featuring updates on regulatory
matters concerning oils- and fats-related industries.
The US Environmental Protection Agency’s
(EPA’s) apparent policy to stop using “non- 5(e)
Snurs” under the new Toxic Substances Control
Act (TSCA) is delaying products from coming to
market and stifling innovation of safer alternatives, according to some chemical manufacturers and industry consultants.
Under the reformed TSCA, the new chemicals review
process has slowed, and the percentage of substances subject
to consent orders has risen sharply. With these changes, it
appears that the EPA has also discontinued its use of so-called
non- 5(e) Snurs to manage potentially concerning uses outside
of those enumerated in a pre-manufacture notice (PMN).
But the agency’s website indicates that “a small subset of
PMNs that previously would have been “dropped” from review
and for which a non-section 5(e) Snur would have been issued
... will now be subject to [ 5(e)] orders.”
LIFE HAS CHANGED
At an American Chemistry Council GlobalChem conference
held earlier in the year, Marcia Levinson, regulatory affairs specialist at chemicals firm Covestro, said that “life has changed
for industry” as far as new chemicals are concerned.
The advent of the EPA no longer using non- 5(e) Snurs
means that now new substance manufacturers must frequently enter into a consent order for “something that they did
not even foresee in their PMN application,” she said.
And while the order is being written, the manufacturer
must wait beyond the 90-day PMN review period before their
new substance can go to market—a process she says takes a
minimum of 60 days. The resulting consent order may also
contain testing requirements for foreseeable uses.
“This definitely has an impact on our innovative spirit,”
Further, she said that it is more challenging to sell a regulated product than a non-regulated one.
“The perception is that a regulated chemical is much
more hazardous than a non-regulated chemical,” said Levison.
“Therefore, we’ve got a discrepancy in terms of the perception
of the impact of this regulation.”
Even if companies are able to work with customers to
explain that this is simply the new way of doing business, there
is still the added burden of managing a regulated chemical,
such as recordkeeping requirements, export notifications,
lower chemical data reporting (CDR) rule reporting thresholds,
or changes to existing hazcom practices.
For these reasons, she said, “it’s hard to get customers to
go toward these new chemicals.”
Lisa Marie Nespoli, also of Covestro, agreed: “We’re cre-
ating safer models that are more sustainable, and nobody
wants to buy them because they have the recordkeeping
“That is our biggest concern for our innovation pipeline—
we are creating things that are better, this is what everybody
wants—but yet we can’t get them through, and I don’t know
how we fix that.”
US STATE LEGISLATIVE ACTIVITY
Meanwhile, state legislative activity on chemicals remains as
high as ever despite the passage of the Lautenberg Chemical
Safety Act, according to industry groups.
Many in industry had looked to the Toxic Substances
Control Act (TSCA) reform to stem the growth of state-level
legislation on chemicals in products, but state activity appears