Overview
On June 22, 2016, The Frank R. Lautenberg Chemical Safety for the 21st Century Act was signed and went into effect, substantially amending the Toxic Substances Control Act (“TSCA”) of 1976. Prior to the revision, the United States Environmental Protection Agency (“EPA” or “the Agency”) had the ability, but not the obligation to review the safety of chemicals, and had no deadlines for completing actions. The new law requires EPA to review chemicals through a more structured process, imposes strict deadlines, provides new funding, and gives the Agency authority to require the development of chemical information. The overall goal is to eliminate unreasonable risks to the public health and the environment.
The New Review Process
EPA is now required to prioritize and evaluate risk using a new risk-based safety standard for all chemicals, whether they are new to the market or have been used for decades. Previously, EPA was required to balance cost and benefit in its risk analysis. Under the new law, risk is considered without cost or any other non-risk issue. The safety of susceptible and highly exposed populations must be considered.
For existing chemicals, EPA must determine whether the chemicals are “high” or “low” priority. “High priority” means that the chemical may present an unreasonable risk to health and the environment; “low priority” means that the chemical does not present an unreasonable risk. Before EPA designates a chemical as high priority, stakeholders will have an opportunity to submit information. A manufacturer may also request a high priority designation. For chemicals already listed by EPA, the manufacturer must pay 50% of the cost of the evaluation. If the chemical is not already listed, the manufacturer must pay 100%. Once a chemical is designated high priority, the evaluation must be complete in three years. For all new chemicals, including those that are imported into the United Sates, a priority determination must be made before it may enter the market. There is an exemption process for chemicals that are determined to be critical or essential, which means that if the chemical is removed from the market, it would disrupt national economy, security or critical infrastructure and there are no reasonable alternatives.
If EPA determines that the chemical presents an unreasonable risk, may present an unreasonable risk, or if the information provided to EPA is insufficient, EPA must take action to address the risk. Unlike the priority determination, cost and availability of alternatives are considered in the risk management action. Actions include the EPA applying to the federal court to ban or to issue an injunction limiting a chemical’s use. Additionally, EPA may restrict the chemical’s use with an immediately effective rule, or with an order (usually issued by consent). If EPA finds the chemical is not likely to present an unreasonable risk, EPA will publish this determination.
By June 2017, EPA must be in the process of evaluating at least 10 high priority chemicals. By December 2019, there must be 20 risk evaluations underway and EPA must have made at least 20 low priority designations. Chemicals that are being reviewed as a result of manufacturer’s petition do not count towards this number, but EPA may not evaluate more than 30 high priority chemicals at a time.
The draft procedural rules for the review process must be published by December 2016, and then will be open for public comment for a limited period of time. The final rule must be published by June 2017.
Other Important Changes
1. Preemption
If the EPA determines a chemical does not pose an unreasonable risk, State rules on that chemical are preempted. States are also prohibited from enacting laws relating to chemicals that are currently being evaluated by EPA under TSCA, but there are certain exceptions to this prohibition. All state restrictions in effect before May 2016 are exempt from preemption. There are a handful of additional prospective carve outs, such as California’s Proposition 65.
2. Confidential business information
The new law requires companies to substantiate their confidentiality claims. EPA must review all past confidentiality claims, and those for new chemicals. In the past, EPA only reviewed approximately 10-20% of such claims. In other words, 80-90% of past confidentiality claims may be re-opened for review. Confidential claims also expire after ten years, so a manufacturer must re-assert confidentiality claims after ten years if it wishes the information to remain confidential.
3. Testing
In the past, rulemaking under TSCA would last three years or longer. Under the new law, EPA can quickly require manufacturers or processors to develop chemical information under an EPA order, or manufacturers may volunteer to do so. This will both expedite the process, and shift the financial burden of testing to manufacturers of high priority chemicals both currently in commerce and attempting to come into the United States.
Copyright © 2016 by N.W. Bernstein & Associates, LLC. This notice is for general information purposes only and does not provide legal advice or create an attorney/client relationship with any recipient. It may be considered Attorney Advertising under New York ethical rules. Prior results do not guarantee a similar outcome.
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