Your New TSCA Rules Breakdown

Posted on 6/14/2016 by James Griffin

Update 06/22/16: Today, President Obama signed the new TSCA reform bill into law. "If we can get this bill done," the President said, "it means somewhere out there on the horizon, we can make our politics less toxic as well."

Earlier this month, both chambers of the US Congress passed a long awaited reform bill to re-work the nation's premier chemical law, the Toxic Substances Control Act (TSCA). With the "new" TSCA now set to become law, it's time to take look at exactly what Congress passed, and what new regulations chemical manufacturers, importers, and processors should expect EPA to create to enact new requirements in the law.

The "Old TSCA"

Under the old TSCA of 1976, EPA could only limit the commercial use of "new" chemicals, and even then only immediately after the chemicals were introduced in commerce. Once a chemical substance established itself in the commercial world, EPA could only restrict new uses of the substance. Thus, EPA's powers under TSCA were very limited compared to its authority under other environmental laws of that era.

The old TSCA officially forbid EPA from regulating any of the tens of thousands of chemicals already in commerce before 1976, except as specifically directed by Congress (for example, lead in paint and gasoline, PCB transformers, etc.), and effectively prohibited regulation of new chemicals by imposing significant procedural and evidentiary burdens on the Agency.

The "New TSCA"

Under the New TSCA of 2016, EPA does have the authority and responsibility to proactively evaluate the risks of all chemical substances. This will be a multi-step process of:
  • Developing a screening process to identify high-priority chemical substances,
  • Designating chemical substances as high- or low-priority,
  • Evaluating the risks of high-priority substances,
  • Determining whether they present an unreasonable risk, and
  • Issuing rules to restrict the use of substances that present an unreasonable risk.

TSCA chemical management and reporting

A Risk-based Screening Process

Once the law officially enters into force, EPA will have one year to establish regulations for a risk-based screening process to designate chemical substances as either high- or low-priority. The priority assignment/designation has to happen before EPA can begin evaluating the risks of the high-priority substances.

The screening process must include consideration of a substance's hazards and its exposure potential (including potential for persistence in the environment, bioaccumulation, storage near significant sources of drinking water, and potential exposure of susceptible subpopulations); the conditions of its use; and the volume that is manufactured or processed.

A substance will be designated a high-priority substance if EPA concludes that it may present an unreasonable risk of injury to health or the environment because of a potential hazard and a potential route of exposure under the conditions of use, including an unreasonable risk to an identified potentially exposed or susceptible subpopulation.

Priority Designations

To reiterate, a high-priority substance is one that has an inherent hazardous property and may in its ordinary manner of use present an unreasonable risk to the environment generally, to public health generally, or to the health of a particular exposed subpopulation.

All other substances are designated low priority for risk evaluation.

EPA is not to consider costs or other non-risk factors when designating a substance as high or low priority.

Priority designations are supposed to take between 9 and 12 months per chemical and include a public notice-and-comment period before and after designation announcement.

Designations may be revised upon the receipt of new information.

Risk Evaluations

Once the law officially enters into force, EPA will have one year to establish regulations for the risk-evaluation process.

Once a chemical substance is designated as a high-priority substance, EPA must begin a risk evaluation for that substance. Risk evaluations must proceed on a timely schedule, with a public notice of the scope of the evaluation between 3 and 12 months after the chemical substance is identified as a high-priority substance.

When evaluating the risk of a high-priority chemical substance, EPA must consider publicly available information on the substance's hazards, uses, and exposures.

Risk evaluations aren't supposed to take longer than 3 years between designation as high priority and completion. Risk evaluations must close with a Federal Register public notice-and-comment period. Risk evaluations aren't supposed to consider public or private costs.

Promulgation of Rules

If, upon completion of a risk evaluation, EPA determines that a chemical substance presents an unreasonable risk of injury to health or the environment, EPA must issue rules to protect human health and the environment by restricting the commercial use of that chemical substance.

Proposed regulations must be issued no later than 1 year after the conclusion of the risk evaluation, and final rules must be issued no later than a year after the proposal.

When issuing rules limiting the use of a dangerous chemical substance, EPA is supposed to consider the costs of any restrictions. Consideration of costs includes a measure of the benefits of the uses of the chemical substance and its mixtures, the likely effect of any rule on the national economy and the environment, and the availability of alternative substances.

Initial Schedule of Works

Initial deadlines include:
  • 180 days after enactment, EPA must have at least ten risk evaluations underway.
    • An initial list of high-priority chemicals was identified in the 2014 TSCA Work Plan for Chemical Assessments.
  • 3.5 years after enactment, EPA must have at least 20 high-priority risk evaluations underway (at least half of them from the 2014 Work Plan) and at least 20 substances designated as low priority.
  • 3 years after enactment, EPA must propose rules restricting the use of certain persistent and bioaccumulative substances already identified as presenting unreasonable risks.
    • Final rules must be issued no later than 18 months after initial proposals.
We've just scratched the surface of new TSCA chemical testing procedures. There's much more in the law, including how EPA nad chemical manufacturers will share the costs of testing, how confidential business informaiton (CBI) will be managed, and when and how EPA must report its progress to the public. In addition, the new TSCA law:

  • Raises the baseline penalty amount for violations of TSCA law from $25,000 to $37,500 or $50,000;
  • Modifies the imminent hazard provisions of TSCA Section 7  to ignore cost considerations from hazard determinations;
  • Sets up a periodic small business review panel for chemical inventory and other reporting under section 8 of TSCA (15 USC 2607);
  • Restricts and places conditions on the storage and disposal of  mercury compounds , including a prohibition on the export of mercury effective January 1, 2020; and
  • Prempts state or local authorities from creating new laws or rules governing chemicals which would conflict with federal TSCA laws & rules.

Lion Technology will continue to track and report updates to TSCA and other major US EPA regulatory programs—the Clean Air Act, Clean Water Act, EPCRA, FIFRA, RCRA, and more—here at Lion News.

TSCA Training for Chemical Reporting, Recordkeeping, and Management

The 2016 TSCA reporting period started on June 1. Be confident you know the latest rules! The TSCA Regulations Online Course is designed to help chemical industry professionals identify the chemicals subject to the regulations, navigate the complex management rules for handling, storing, processing, and producing chemicals (including PCBs), and understand the TSCA reporting and recordkeeping requirements.

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