Chemical notification process
“very different” under new TSCA
Regulatory Review is a regular column featuring updates on regulatory
matters concerning oils- and fats-related industries.
Bringing a new chemical to the market under
the new Toxic Substances Control Act (TSCA)
will be a very different process to that which
manufacturers have grown accustomed to.
As amended by the Lautenberg Chemical
Safety Act, TSCA now requires an “affirmative
finding” of safety for pre-manufacture notices
(PMNs). If the agency decides a substance
poses an unreasonable risk, it must issue an
order to prohibit or restrict it—and these are
already on the rise in the program’s early days.
According to Jeffrey Morris, deputy director for programs at Office of Pollution Prevention and Toxics (OPPT), this
requirement is a very big change to the new chemicals process.
And Lynn Bergeson, managing partner at Bergeson &
Campbell, said she’s not sure industry appreciates “just how
significantly the ballgame has changed.”
EVOLVE AND DEVELOP
Morris said the new TSCA will evolve and develop through
“It’s going to be a lot of working through particular cases
and learning from them. We’re going to have to look at what
we’ve done and realize—maybe we should have done this a
different way, and make adjustments. That’s just going to be
the nature of implementing a significant change to the law.”
But Bergeson pointed out that it’s not incumbent on just
the US Environmental Protection Agency (EPA) to manage the
change. PMN submissions, she said, will now require more
strategic review, and companies should more closely consider
available information that can be submitted “to rebut certain
inferences that otherwise might follow.”
OBSERVATIONS ON THE GROUND
Sharing her perspectives as a product stewardship manager,
Shannon Gainey, from global specialty chemicals company
Evonik Corporation, said companies will need a couple of years
to “weather the storm” of the new chemicals process.
Regarding the affirmative determination, Gainey said in
her experience, unless a new substance being notified has a
low human health hazard and low environmental hazard, there
will be a hazard consideration. And, unless the exposure to this
substance is essentially zero, the EPA will likely identify a risk.
Bearing in mind how the EPA evaluates new chemistries,
she said, the agency’s models “will predict a very conserva-
tive number in terms of how potentially toxic something is, and
the models generally will overestimate the quantity potentially
released to the environment,” based on manufacturing, pro-
cessing and uses described in the PMN.
So in situations where a chemical has predicted toxicity—
especially ecotoxicity—a PMN submitter, she said, may benefit
from producing data. This is particularly the case for chronic
toxicity, as this is an area where data gaps may force the EPA to
rely on the outcome of models instead.
Further considerations for businesses, she said, include:
• allowing for, and communicating to customers, a longer
lead time to bring new substances to the market;