• planning for increased costs;
• communicating early and often with the EPA, particularly around what assumptions it is using in its evaluations, or on the data gaps it faces;
• increased testing, including possibly expanding capacity
to run phys-chem properties;
• preparing for increased controls and restrictions follow-
ing the review process, including educating customers
that significant new use rules (Snurs) and orders are the
way of the future; and
• collaborating within industry, including sharing case
Gainey also said that companies may consider alternative
uses for existing substance already on the inventory, while the
new chemicals process continues to mature.
Under the new law, the EPA must now make an affirmative
finding of safety on both the known and “reasonably foreseen”
uses of a substance.
Morris said the agency’s interpretation of the law is that
“known uses” are those included in a PMN. The EPA is currently interpreting “reasonably foreseen” to mean the known
uses of similar substances.
“If there are uses associated with a close analog to this
chemical—a chemical that seems that it’s closely related and
could likely be used in the same way as the PMN substance—
and [these uses] are not on the PMN form, then we have to
make our determination not only on the uses that are in the
PMN form, but also on those reasonably foreseen uses.”
In the past, he said, a minority of submitters received con-
sent orders but “that’s going to change now.” The agency will
need to issue an order and a significant new use rule (Snur) to
articulate what protections would be needed to address a find-
ing for not only the known use, but also for those reasonably
In many cases, the order might just bind the submitter to
the conditions outlined in its PMN. But, said Morris, “it’s still an
order, and it’s still something new.”
Regarding the law’s new insufficient information finding, Morris
said this is also a new area for industry and the EPA alike. As
“most PMN submissions do not come with a full battery of information that would allow us to make a determination,” in many
cases, the EPA will rely on analogous substances, he said.
But “it’s not clear that in a lot of those cases that just
going from an analogy—without a full body of information
from a PMN submission—is going to allow us to move past that
designation of ‘insufficient information.’”
This raises several questions, said Morris, such as:
• what are the testing implications for insufficient
• what information does the law require the agency to
ask for beyond what it has previously requested for new
• should the EPA require tests that the regulated com-
munity is familiar with, or should the agency be explor-
ing more ‘creative’, or alternative ways that it can
use to gather the information it needs to make its
Evonik’s Gainey said that for some early PMN determinations, the agency’s upfront testing requests have apparently
been “pretty significant.” Some have included 90–day inhalation studies, for example.
“It will be clear very soon,” said Morris, that the discussion
around the testing implications of the changes to Section 5 of
TSCA will be “very important” to how the EPA operates.
Kelly Franklin is editor, North America, for Chemical Watch .
©2016. Reproduced from Chemical Watch by permission of CW
Research Ltd. www.chemicalwatch.com