EPA Proposes Rules to Implement TSCA Reform

by Jones Day

Jones Day

The Frank R. Lautenberg Chemical Safety for the 21st Century Act was signed into law on June 22, 2016. We previously summarized that bill's key changes to the Toxic Substances Control Act ("TSCA"). This Commentary highlights several rules that the United States Environmental Protection Agency ("EPA") recently proposed to implement the new law. Comments on each of these rules are due in March, with final rules to be issued by summer 2017.

Inventory Reset Rule

On January 13, 2017, EPA proposed the TSCA Inventory Notification (Active-Inactive) Requirements rule ("Inventory Reset Rule"). The Inventory Reset Rule stems from the mandate in the amended TSCA for EPA to designate chemical substances on the TSCA Inventory as either "active" or "inactive" in United States commerce. Under the proposed rule, manufacturers will be required, and processors have the option, to report each chemical substance on the TSCA Inventory that they manufactured or processed for nonexempt commercial purposes during the 10 years between June 21, 2006, and June 21, 2016. Chemicals not reported will be designated as "inactive." Going forward, a person who wants to manufacture or process a chemical designated as inactive would be required to notify EPA in advance. All reporting under this rule must be submitted electronically through EPA's Central Data Exchange portal, and there is a five-year recordkeeping requirement for those that submit any notices under the rule. For active chemicals on the confidential portion of the TSCA Inventory, if those submitting notices want to keep information about the chemical confidential, they must substantiate the need for continued treatment as confidential. Comments on the Inventory Reset Rule are due by March 14, 2017. The Inventory Reset Rule is expected to be finalized by summer 2017, with manufacturer notices due within 180 days and processor notices due within 360 days of publication of the final rule in the Federal Register. If a chemical substance is designated as "active" it is eligible for consideration under the Prioritization Rule.

Prioritization Rule

EPA proposed a rule entitled Procedures for Prioritization of Chemicals for Risk Evaluation Under the Toxic Substances Control Act ("Prioritization Rule") on January 17, 2017. Comments on the Prioritization Rule are due by March 20, 2017. The Prioritization Rule will establish the process and criteria that EPA will use to identify chemical substances as either "high priority" or "low priority." High priority chemicals will then be subject to risk evaluation. EPA proposes that the prioritization process would include the following steps: pre-prioritization; initiation; proposed designation; and final designation. 

In the pre-prioritization stage, EPA would consider whether the chemical substance meets one or more of the following criteria: persistent, bioaccumulative, and toxic; used in children's products; used in consumer products; detected in human and/or ecological biomonitoring programs; potentially of concern for children's health; high acute and chronic toxicity; probable or known carcinogen; neurotoxicity; and other emerging exposure and hazard concerns to human health or the environment. EPA would then perform a screening review using the following considerations: hazard exposure potential; persistence and bioaccumulation; potentially exposed or susceptible subpopulations; storage near significant sources of drinking water; conditions of use; production volume; and any other relevant risk-based criteria. Pursuant to the amendments to TSCA, EPA may not consider costs or other non-risk factors at any point in this process.

The initiation phase would involve publication of the results of EPA's screening review in the Federal Register to allow for a 90-day public comment period. EPA would then publish a proposed designation in the Federal Register and commence another 90-day comment period. Any comments on proposed designations of chemicals as low priority must be submitted during this window or will be considered waived. Lastly, EPA would issue a final designation between 9 and 12 months following publication of the screening review in the Federal Register.

EPA has noted that the bar for prioritizing a chemical as low priority is relatively high, and that if EPA has insufficient information to designate a chemical as low priority, it will be designated as high priority. The proposed rule also states that EPA may revise a final designation of low priority to high priority at any time if it receives information suggesting the need for such a change. Under the Prioritization Rule, a low priority designation would be considered final agency action subject to judicial review. A high priority designation would not be subject to judicial review, but would trigger the obligation for EPA to commence an assessment under the Risk Evaluation Rule.

Risk Evaluation Rule

Under the revised TSCA, EPA must perform risk evaluations for certain chemicals, including chemicals designated as high priority,[1] to determine whether they present an unreasonable risk of injury to health or the environment. On January 19, 2017, EPA proposed a rule outlining how it will conduct such risk evaluations: Procedures for Chemical Risk Evaluation Under the Toxic Substances Control Act ("Risk Evaluation Rule").[2] EPA proposes that risk evaluations would include the following components: scope, including a conceptual model and analysis plan; hazard assessment; exposure assessment; risk characterization; and risk determination. 

The scope would be based on various factors, including conditions of use (actual and reasonably foreseeable), potentially exposed populations, and life cycle of the chemical. EPA plans to publish proposed scopes in the Federal Register for public review and comment no later than three months after initiating a risk evaluation. Comments on scope not made during the 30-day comment period will be considered waived. After the final scope is published in the Federal Register, EPA would conduct a hazard assessment by evaluating potential human and environmental hazard endpoints. EPA would then conduct an exposure assessment and develop a risk characterization, which would be peer reviewed. (EPA has, however, requested comments on whether there are circumstances where peer review is not warranted.) EPA would then publish a draft risk assessment in the Federal Register and provide the opportunity for public review and comment. All comments that could be raised regarding the draft risk assessment must be made during this comment period or will be considered waived.

As a final step, EPA would publish a final risk evaluation, determining whether the chemical poses an unreasonable risk of injury to health or the environment. EPA's finding would be published in the Federal Register no later than three years after the date on which the risk evaluation is initiated, with the potential for an extension of up to six months. If EPA concludes that the chemical does pose an unreasonable risk, the revised TSCA obligates the agency to draft rules designed to prevent such risk. A determination that a chemical does not pose an unreasonable risk, however, is considered a final agency action. Comments on the Risk Evaluation Rule are due by March 20, 2017. 

1 Other chemicals subject to risk evaluation are the first 10 chemicals selected by EPA from the update to the TSCA Work Plan and chemicals requested for risk evaluation by manufacturers. 

2 This proposed rule also lays out the steps for manufacturers that want to request a risk evaluation.

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

© Jones Day | Attorney Advertising

Written by:

Jones Day

Jones Day on:

Readers' Choice 2017
Reporters on Deadline

"My best business intelligence, in one easy email…"

Your first step to building a free, personalized, morning email brief covering pertinent authors and topics on JD Supra:
Sign up using*

Already signed up? Log in here

*By using the service, you signify your acceptance of JD Supra's Privacy Policy.
Custom Email Digest
Privacy Policy (Updated: October 8, 2015):

JD Supra provides users with access to its legal industry publishing services (the "Service") through its website (the "Website") as well as through other sources. Our policies with regard to data collection and use of personal information of users of the Service, regardless of the manner in which users access the Service, and visitors to the Website are set forth in this statement ("Policy"). By using the Service, you signify your acceptance of this Policy.

Information Collection and Use by JD Supra

JD Supra collects users' names, companies, titles, e-mail address and industry. JD Supra also tracks the pages that users visit, logs IP addresses and aggregates non-personally identifiable user data and browser type. This data is gathered using cookies and other technologies.

The information and data collected is used to authenticate users and to send notifications relating to the Service, including email alerts to which users have subscribed; to manage the Service and Website, to improve the Service and to customize the user's experience. This information is also provided to the authors of the content to give them insight into their readership and help them to improve their content, so that it is most useful for our users.

JD Supra does not sell, rent or otherwise provide your details to third parties, other than to the authors of the content on JD Supra.

If you prefer not to enable cookies, you may change your browser settings to disable cookies; however, please note that rejecting cookies while visiting the Website may result in certain parts of the Website not operating correctly or as efficiently as if cookies were allowed.

Email Choice/Opt-out

Users who opt in to receive emails may choose to no longer receive e-mail updates and newsletters by selecting the "opt-out of future email" option in the email they receive from JD Supra or in their JD Supra account management screen.


JD Supra takes reasonable precautions to insure that user information is kept private. We restrict access to user information to those individuals who reasonably need access to perform their job functions, such as our third party email service, customer service personnel and technical staff. However, please note that no method of transmitting or storing data is completely secure and we cannot guarantee the security of user information. Unauthorized entry or use, hardware or software failure, and other factors may compromise the security of user information at any time.

If you have reason to believe that your interaction with us is no longer secure, you must immediately notify us of the problem by contacting us at info@jdsupra.com. In the unlikely event that we believe that the security of your user information in our possession or control may have been compromised, we may seek to notify you of that development and, if so, will endeavor to do so as promptly as practicable under the circumstances.

Sharing and Disclosure of Information JD Supra Collects

Except as otherwise described in this privacy statement, JD Supra will not disclose personal information to any third party unless we believe that disclosure is necessary to: (1) comply with applicable laws; (2) respond to governmental inquiries or requests; (3) comply with valid legal process; (4) protect the rights, privacy, safety or property of JD Supra, users of the Service, Website visitors or the public; (5) permit us to pursue available remedies or limit the damages that we may sustain; and (6) enforce our Terms & Conditions of Use.

In the event there is a change in the corporate structure of JD Supra such as, but not limited to, merger, consolidation, sale, liquidation or transfer of substantial assets, JD Supra may, in its sole discretion, transfer, sell or assign information collected on and through the Service to one or more affiliated or unaffiliated third parties.

Links to Other Websites

This Website and the Service may contain links to other websites. The operator of such other websites may collect information about you, including through cookies or other technologies. If you are using the Service through the Website and link to another site, you will leave the Website and this Policy will not apply to your use of and activity on those other sites. We encourage you to read the legal notices posted on those sites, including their privacy policies. We shall have no responsibility or liability for your visitation to, and the data collection and use practices of, such other sites. This Policy applies solely to the information collected in connection with your use of this Website and does not apply to any practices conducted offline or in connection with any other websites.

Changes in Our Privacy Policy

We reserve the right to change this Policy at any time. Please refer to the date at the top of this page to determine when this Policy was last revised. Any changes to our privacy policy will become effective upon posting of the revised policy on the Website. By continuing to use the Service or Website following such changes, you will be deemed to have agreed to such changes. If you do not agree with the terms of this Policy, as it may be amended from time to time, in whole or part, please do not continue using the Service or the Website.

Contacting JD Supra

If you have any questions about this privacy statement, the practices of this site, your dealings with this Web site, or if you would like to change any of the information you have provided to us, please contact us at: info@jdsupra.com.

- hide
*With LinkedIn, you don't need to create a separate login to manage your free JD Supra account, and we can make suggestions based on your needs and interests. We will not post anything on LinkedIn in your name. Or, sign up using your email address.