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On June 22, 2016, President Obama signed the "Frank R. Lautenberg Chemical Safety for the 21st Century Act" into law, making comprehensive changes to the Toxic Substances Control Act (TSCA).
On June 22, 2016, President Obama signed the "Frank R.
Lautenberg Chemical Safety for the 21st Century Act" into law,
making comprehensive changes to the Toxic Substances Control Act
(TSCA). This step comes after years of congressional attempts to
update the Act.
The changes to TSCA will have sweeping effects on various
industries and manufacturers, as the law regulates a wide variety
of household, commercial, and industrial chemicals. In the past,
TSCA had been criticized in part due to its piecemeal regulation of
only certain industries and chemicals, and the regulation of
certain chemicals only through more stringent state-enacted rules.
The new law provides more certainty for regulated parties and
grants the U.S. Environmental Protection Agency (U.S. EPA) broader
authority to regulate chemicals currently in the stream of
commerce.
Preemption
Under the new law, the EPA rules implementing the Act preempt
many new state rules related to chemicals. However, state chemical
limitations passed prior to April 22, 2016, as well as any new
actions taken under a state law that existed prior to August 31,
2003, are "grandfathered" and enforceable by the state,
including, notably, California's Proposition 65. Additionally,
under the new TSCA, states may not enact new more stringent rules
than existing EPA rules, and thus, the law sets a national
framework for chemical regulation rather than a state-by-state
scheme. The preemption elements of the law were hotly contested
throughout the legislative process, and the outcome is generally
seen as a benefit to industry that will result in more universally
consistent regulation.
Expanded Agency Authority
The changes to TSCA also grant the EPA greater testing authority
and allow the Agency to test chemicals of concern without first
proceeding through the lengthy rulemaking process. Under the
previous Act, the EPA could only test a new chemical for its
toxicity after issuing a notice-and-comment rulemaking, which is a
resource intensive and complex process. The new law allows the EPA
to order the testing of new chemicals without a rulemaking.
Another significant change is that the new TSCA requires the EPA
to review all chemicals that are in active commerce for
safety— prioritizing review of the most dangerous chemicals
first. The EPA is required to conduct a risk evaluation of all
chemicals that are already in the stream of commerce. This is a
significant change in the Act. Previously, TSCA required the EPA to
demonstrate that a chemical posed a risk before it could require
the manufacturer of the chemical to provide information, perform
testing, or perform any risk analysis. Now, TSCA gives the EPA
broad authority to require companies to provide health and safety
data for previously untested chemicals, and the authority to keep
new products out of the marketplace if they pose a risk to health
or safety. In addition to the EPA's greater authority to
require testing and evaluation of chemicals, this new TSCA also
requires that companies provide an upfront justification for
treating information that is submitted to the EPA as confidential
business information, including data and testing information.
Revised Criteria for Chemical Review
The new law also establishes revised criteria for how the EPA
designates chemicals and issues new rules. Under the previous Act,
the EPA was required to conduct a cost-benefit analysis,
considering the financial impacts and compliance costs, of
regulating a new chemical. Ultimately, under the prior law, the EPA
was required to regulate a chemical in the least burdensome manner.
TSCA still permits EPA to consider economic effects, but mandates
that any restrictions be based on the environmental, health, and
safety effects of a chemical in the risk evaluation. This
health-based standard is a significant change from the previous
law. In this vein, the new TSCA is also sensitive to particularly
susceptible classes of individuals such as chemical workers,
pregnant women, children, and disadvantaged communities, and
prioritizes chemicals stored near drinking water and those that are
highly toxic.
Mandated Chemical Evaluation – Timing
The EPA is subject to several timing components under the new
law. The EPA has one year after the law is enacted to establish a
rule implementing a risk evaluation process for existing listed
chemicals. Within six months of the law's enactment the EPA
must identify ten "high-priority" chemicals for risk
evaluation. Within three and a half years, twenty
"high-priority" chemicals and twenty
"low-priority" chemicals must be identified by the EPA.
Once the EPA finds that a chemical poses an unreasonable risk, the
agency must propose a rule to manage the chemical and its risks
within one year.
Overall, a comprehensive change to the way chemicals are
regulated in this country has been enacted and the new TSCA will
have broad implications for a wide variety of businesses as
thousands of previously untested chemicals may now be subject to
testing and information disclosure requirements. However, the Act
is not retroactive and will take effect 180 days after the date of
enactment, or December 19, 2016.
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