Pressure Points
TSCA Prioritization:
STEVE BENNETT, Ph.D.
SVP, Scientific What is it good for? Affairs, HCPA
The U.S. Environmental Protection Agency (EPA) recently
designated 20 High Priority chemicals under the Toxic
Substances Control Act (TSCA).1 This is the latest implementation
step in the multi-year process of changes required by
the amendments to TSCA by the Frank R. Lautenberg Chemical
Safety Act of 2016 signed into law by then President Obama. So,
what does prioritization mean? What, if anything, should interested
parties do?
The High Priority designation is a new process within the reformed
TSCA in which EPA identifies potential chemicals for risk
evaluation. Chemicals designated as High Priority are identified
by using (1) hazard and exposure potential or a category of chemical
(including consideration of persistence and bioaccumulation,
potentially exposed or susceptible subpopulations and storage
near significant sources of drinking water), (2) the conditions of
use or significant changes in the conditions of use of the chemical
and (3) the volume or significant changes in the volume of the
chemical manufactured or processed. High Priority chemicals
can also be selected from the remaining chemicals on EPA’s 2014
Work Plan.
It is important to note that the High Priority designation is not
a finding of unreasonable risk. Rather, it means that the identified
chemical shall have its conditions of use evaluated for determination
of unreasonable risk. It is critical that the information
EPA has on a chemical is accurate and complete to ensure robust
decisions. Incomplete or missing information will undoubtably
lead to less than ideal decisions or excessively conservative risk
estimates, neither of which are in the best interest of EPA or
the industry. In addition to leading to robust and defensible
decisions, comprehensive information will allow EPA to focus
resources effectively and appropriately.
EPA is required to select at least 50% of the High Priority
chemicals from the 2014 Work Plan, which uses hazard, exposure
and a persistent and bioaccumulation screening criterion, until
that list is depleted. This time, EPA identified all 20 High Priority
chemicals exclusively from the 2014 Work Plan—a prudent decision
at this time, but not one to expect for future High Priority
designations since available screening tools will likely improve.
While the information gathered in 2014 was as accurate and
complete as possible at that time, it has not been significantly
updated since, and, in some cases, may be based upon relatively
old information.
Many of the 20 High Priority chemicals have experienced
considerable scrutiny—the phthalates come to mind—and market
usage has shifted noticeably for these chemicals. It would certainly
benefit interested parties to provide relevant information that can
help fill any data gaps, and to reflect any changes in the conditions
of use or markets since the original identification. Interested
parties should provide information to EPA as an individual
company via a trade association or consortium.
EPA will utilize this information to formally designate a chemical
as High Priority. This activity officially starts the three-year
clock to complete the risk evaluation for all the conditions of use
of the chemical. If any of the conditions of use pose an unreasonable
risk during evaluation, the chemical will move to risk
management. Alternatively, the evaluation can show that no unreasonable
risk is identified, as is the case with the first draft risk
evaluation of Pigment Violet 29. Risk management will ascertain
if the condition(s) of use can have the unreasonable risk mitigated
through label guidance, personal protective equipment or a wide
range of restriction options to include prohibitions of use.
A couple of chemicals on the High Priority list deserve special
attention and interested parties will very likely provide information
to assist EPA in their data gathering efforts, specifically
HHCB (galaxolide) and trans-1,2-dichloroehtylene.
HHCB is particularly interesting because this common fragrance
component was the first completed risk assessment of the
2014 Work Plan chemicals.2 The previous risk assessment focused
on the human health impacts, of which it found none, but did
note the “inability to assess potential risks to terrestrial invertebrates
and plants is a major uncertainty.” Therefore, HHCB will
most likely undergo an updated environmental assessment to
address these concerns.
Trans-1,2-dichloroethylene has been living on borrowed time
since it was expected to be evaluated within the First Ten Chemicals
currently under evaluation—many of which are also chlorinated
solvents. Interested parties should carefully consider providing
information to EPA regarding the conditions of use, markets of
use and other stewardship activities of trans-1,2-dichloroethylene.
There may also be interest in eliciting ideas from EPA’s recent
proposal for a Certification and Limited Access Program for Commercial
Paint and Coating Removal uses of methylene chloride.3
In conjunction with announcing the 20 High Priority chemicals,
EPA also announced the first 20 Low Priority chemicals.
These chemicals were identified primarily from EPA’s Safer
Chemical Ingredient List (SCIL)4 and mostly indicate that all
conditions of use do not present unreasonable risk. Similarly,
interested parties are encouraged to provide information to EPA
supporting (or refuting) this designation. If a chemical is designated
as Low Priority, it would be of considerable interest for
formulators and manufacturers to utilize this chemical.
Considering all of this, interested parties should carefully
review the list of 20 High Priority and 20 Low Priority chemicals
and submit relevant information such as the current uses, hazards
and exposure information for these chemicals. There is little
doubt that several chemicals in these two lists are going to be of
interest to the aerosol industry—and likely of direct interest to
you. You are encouraged to determine if and how to best submit
relevant information to EPA to assist in making appropriate
designations. Spray
10 Spray June 2019
1 https://www.epa.gov/assessing-and-managing-chemicals-under-tsca/list-chemicals-undergoing
prioritization
2 https://www.epa.gov/assessing-and-managing-chemicals-under-tsca/tsca-work-plan-chemicalrisk
assessment-hhcb-134678
3 https://www.regulations.gov/document?D=EPA_FRDOC_0001-23647
4 https://www.epa.gov/saferchoice/safer-ingredients