United States: EPA Proposes Rules To Implement TSCA Reform

Last Updated: February 27 2017
Article by Jane Borthwick Story, Alina Fortson, Mary Beth Deemer and Kevin Holewinski

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. 

Footnotes

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.

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

To print this article, all you need is to be registered on Mondaq.com.

Click to Login as an existing user or Register so you can print this article.

Authors
Jane Borthwick Story
Kevin Holewinski
Similar Articles
Relevancy Powered by MondaqAI
Arnold & Porter
Arnold & Porter
Arnold & Porter
Smith Gambrell & Russell LLP
 
In association with
Related Topics
 
Similar Articles
Relevancy Powered by MondaqAI
Arnold & Porter
Arnold & Porter
Arnold & Porter
Smith Gambrell & Russell LLP
Related Articles
 
Related Video
Up-coming Events Search
Tools
Print
Font Size:
Translation
Channels
Mondaq on Twitter
 
Register for Access and our Free Biweekly Alert for
This service is completely free. Access 250,000 archived articles from 100+ countries and get a personalised email twice a week covering developments (and yes, our lawyers like to think you’ve read our Disclaimer).
 
Email Address
Company Name
Password
Confirm Password
Position
Mondaq Topics -- Select your Interests
 Accounting
 Anti-trust
 Commercial
 Compliance
 Consumer
 Criminal
 Employment
 Energy
 Environment
 Family
 Finance
 Government
 Healthcare
 Immigration
 Insolvency
 Insurance
 International
 IP
 Law Performance
 Law Practice
 Litigation
 Media & IT
 Privacy
 Real Estate
 Strategy
 Tax
 Technology
 Transport
 Wealth Mgt
Regions
Africa
Asia
Asia Pacific
Australasia
Canada
Caribbean
Europe
European Union
Latin America
Middle East
U.K.
United States
Worldwide Updates
Registration (you must scroll down to set your data preferences)

Mondaq Ltd requires you to register and provide information that personally identifies you, including your content preferences, for three primary purposes (full details of Mondaq’s use of your personal data can be found in our Privacy and Cookies Notice):

  • To allow you to personalize the Mondaq websites you are visiting to show content ("Content") relevant to your interests.
  • To enable features such as password reminder, news alerts, email a colleague, and linking from Mondaq (and its affiliate sites) to your website.
  • To produce demographic feedback for our content providers ("Contributors") who contribute Content for free for your use.

Mondaq hopes that our registered users will support us in maintaining our free to view business model by consenting to our use of your personal data as described below.

Mondaq has a "free to view" business model. Our services are paid for by Contributors in exchange for Mondaq providing them with access to information about who accesses their content. Once personal data is transferred to our Contributors they become a data controller of this personal data. They use it to measure the response that their articles are receiving, as a form of market research. They may also use it to provide Mondaq users with information about their products and services.

Details of each Contributor to which your personal data will be transferred is clearly stated within the Content that you access. For full details of how this Contributor will use your personal data, you should review the Contributor’s own Privacy Notice.

Please indicate your preference below:

Yes, I am happy to support Mondaq in maintaining its free to view business model by agreeing to allow Mondaq to share my personal data with Contributors whose Content I access
No, I do not want Mondaq to share my personal data with Contributors

Also please let us know whether you are happy to receive communications promoting products and services offered by Mondaq:

Yes, I am happy to received promotional communications from Mondaq
No, please do not send me promotional communications from Mondaq
Terms & Conditions

Mondaq.com (the Website) is owned and managed by Mondaq Ltd (Mondaq). Mondaq grants you a non-exclusive, revocable licence to access the Website and associated services, such as the Mondaq News Alerts (Services), subject to and in consideration of your compliance with the following terms and conditions of use (Terms). Your use of the Website and/or Services constitutes your agreement to the Terms. Mondaq may terminate your use of the Website and Services if you are in breach of these Terms or if Mondaq decides to terminate the licence granted hereunder for any reason whatsoever.

Use of www.mondaq.com

To Use Mondaq.com you must be: eighteen (18) years old or over; legally capable of entering into binding contracts; and not in any way prohibited by the applicable law to enter into these Terms in the jurisdiction which you are currently located.

You may use the Website as an unregistered user, however, you are required to register as a user if you wish to read the full text of the Content or to receive the Services.

You may not modify, publish, transmit, transfer or sell, reproduce, create derivative works from, distribute, perform, link, display, or in any way exploit any of the Content, in whole or in part, except as expressly permitted in these Terms or with the prior written consent of Mondaq. You may not use electronic or other means to extract details or information from the Content. Nor shall you extract information about users or Contributors in order to offer them any services or products.

In your use of the Website and/or Services you shall: comply with all applicable laws, regulations, directives and legislations which apply to your Use of the Website and/or Services in whatever country you are physically located including without limitation any and all consumer law, export control laws and regulations; provide to us true, correct and accurate information and promptly inform us in the event that any information that you have provided to us changes or becomes inaccurate; notify Mondaq immediately of any circumstances where you have reason to believe that any Intellectual Property Rights or any other rights of any third party may have been infringed; co-operate with reasonable security or other checks or requests for information made by Mondaq from time to time; and at all times be fully liable for the breach of any of these Terms by a third party using your login details to access the Website and/or Services

however, you shall not: do anything likely to impair, interfere with or damage or cause harm or distress to any persons, or the network; do anything that will infringe any Intellectual Property Rights or other rights of Mondaq or any third party; or use the Website, Services and/or Content otherwise than in accordance with these Terms; use any trade marks or service marks of Mondaq or the Contributors, or do anything which may be seen to take unfair advantage of the reputation and goodwill of Mondaq or the Contributors, or the Website, Services and/or Content.

Mondaq reserves the right, in its sole discretion, to take any action that it deems necessary and appropriate in the event it considers that there is a breach or threatened breach of the Terms.

Mondaq’s Rights and Obligations

Unless otherwise expressly set out to the contrary, nothing in these Terms shall serve to transfer from Mondaq to you, any Intellectual Property Rights owned by and/or licensed to Mondaq and all rights, title and interest in and to such Intellectual Property Rights will remain exclusively with Mondaq and/or its licensors.

Mondaq shall use its reasonable endeavours to make the Website and Services available to you at all times, but we cannot guarantee an uninterrupted and fault free service.

Mondaq reserves the right to make changes to the services and/or the Website or part thereof, from time to time, and we may add, remove, modify and/or vary any elements of features and functionalities of the Website or the services.

Mondaq also reserves the right from time to time to monitor your Use of the Website and/or services.

Disclaimer

The Content is general information only. It is not intended to constitute legal advice or seek to be the complete and comprehensive statement of the law, nor is it intended to address your specific requirements or provide advice on which reliance should be placed. Mondaq and/or its Contributors and other suppliers make no representations about the suitability of the information contained in the Content for any purpose. All Content provided "as is" without warranty of any kind. Mondaq and/or its Contributors and other suppliers hereby exclude and disclaim all representations, warranties or guarantees with regard to the Content, including all implied warranties and conditions of merchantability, fitness for a particular purpose, title and non-infringement. To the maximum extent permitted by law, Mondaq expressly excludes all representations, warranties, obligations, and liabilities arising out of or in connection with all Content. In no event shall Mondaq and/or its respective suppliers be liable for any special, indirect or consequential damages or any damages whatsoever resulting from loss of use, data or profits, whether in an action of contract, negligence or other tortious action, arising out of or in connection with the use of the Content or performance of Mondaq’s Services.

General

Mondaq may alter or amend these Terms by amending them on the Website. By continuing to Use the Services and/or the Website after such amendment, you will be deemed to have accepted any amendment to these Terms.

These Terms shall be governed by and construed in accordance with the laws of England and Wales and you irrevocably submit to the exclusive jurisdiction of the courts of England and Wales to settle any dispute which may arise out of or in connection with these Terms. If you live outside the United Kingdom, English law shall apply only to the extent that English law shall not deprive you of any legal protection accorded in accordance with the law of the place where you are habitually resident ("Local Law"). In the event English law deprives you of any legal protection which is accorded to you under Local Law, then these terms shall be governed by Local Law and any dispute or claim arising out of or in connection with these Terms shall be subject to the non-exclusive jurisdiction of the courts where you are habitually resident.

You may print and keep a copy of these Terms, which form the entire agreement between you and Mondaq and supersede any other communications or advertising in respect of the Service and/or the Website.

No delay in exercising or non-exercise by you and/or Mondaq of any of its rights under or in connection with these Terms shall operate as a waiver or release of each of your or Mondaq’s right. Rather, any such waiver or release must be specifically granted in writing signed by the party granting it.

If any part of these Terms is held unenforceable, that part shall be enforced to the maximum extent permissible so as to give effect to the intent of the parties, and the Terms shall continue in full force and effect.

Mondaq shall not incur any liability to you on account of any loss or damage resulting from any delay or failure to perform all or any part of these Terms if such delay or failure is caused, in whole or in part, by events, occurrences, or causes beyond the control of Mondaq. Such events, occurrences or causes will include, without limitation, acts of God, strikes, lockouts, server and network failure, riots, acts of war, earthquakes, fire and explosions.

By clicking Register you state you have read and agree to our Terms and Conditions