United States: A Bi-Partisan Agreement To Expand EPA Authority To Regulate Toxic Substances

Last Updated: May 16 2017
Article by Amy P. Wang

Rarely do both sides of the legislative aisle in Washington join in overwhelming approval to expand the authority of the Environmental Protection Agency ("EPA").  Recently, the House of Representatives and Senate did just that, and President Obama joined them on June 22, 2016, by signing into law the Frank R. Lautenberg Chemical Safety for the 21st Century Act ("TSCA Reform Act") to update the Toxic Substances Control Act ("TSCA").

In 1976, Congress enacted the TSCA to regulate toxic and chemical substances to prevent "unreasonable risk of injury to health or the environment."  Unlike other environmental laws, the TSCA focused on pollution prevention through regulation of products rather than by regulation of the disposal of wastes.  The idea behind the TSCA was to reduce and prevent unreasonable risks to human health by making industry develop data on the environmental effects of chemicals produced, but without stymieing technological innovation or business growth.  Under the TSCA, the EPA could require manufacturers to test substances prior to introducing a new chemical substance into the market for a "significant new use."  However, the TSCA's balance between environmental protection and economics meant that the EPA was limited to applying the "least burdensome requirement" when restricting the use of harmful chemicals, and this manner of regulating the manufacture, import, processing, distribution, and use of chemicals under the TSCA remained unchanged for 40 years.

The TSCA Reform Act removes the "least burdensome requirement" from the regulation of toxic chemicals to allow the EPA to restrict or ban the use of those substances posing unreasonable risks.  Other significant changes to the TSCA that will affect manufacturers, processors, suppliers, and importers of chemicals include:

  • Risk Assessment and Prioritization:  The EPA will evaluate new and existing chemicals to determine whether they present an "unreasonable risk of injury to health or the environment," and will designate them as high or low priority.  These affirmative determinations are to be made without consideration of cost or other non-risk factors when evaluating harm.  The EPA can issue unilateral orders (in addition to the more common consent agreements already available under the TSCA) to elicit testing from manufacturers on existing chemicals to make its determinations.
  • Reduction of Animal Testing:  The EPA must promote the development and implementation of alternative methods and strategies to reduce the use of vertebrate animals in chemical testing.
  • Pre-Manufacture Notification ("PMN"):  The TSCA mandates that manufacturers submit a PMN to the EPA 90 days prior to commencement of the manufacture or import of a new chemical substance demonstrating that there is no unreasonable risk of injury to health or the environment.  Prior to the TSCA Reform Act, the EPA did not have to make a safety determination, so the manufacture or import of a chemical substance could proceed if there was no response to the PMN from the EPA.  The TSCA Reform Act, however, requires the EPA to review each PMN and make an affirmative determination on the risk of injury from the chemical substance.
  • Preemption:  The TSCA Reform Act is intended to provide a uniform federal scheme preempting and invalidating inconsistent state laws.  The TSCA Reform Act partially precludes states from passing or enforcing laws or regulations that are inconsistent with the TSCA.  The prohibitions differ depending on the chemical subject to restriction, type of state requirements, when the state statute or regulation was put into place, and whether the EPA is undertaking a risk evaluation.  State laws enacted prior to April 2016 are grandfathered.
  • Confidential Business Information ("CBI"): Claims to protect CBI from disclosure to the public will be significantly curtailed under the TSCA amendments.  CBI claims will be limited to 10 years.  Companies must request a renewal for CBI protection and substantiate the need for the continued treatment.  
  • Increased Costs, Penalties, and Prison Terms:  The EPA is now authorized to charge higher fees for its chemical review process.  In addition, the caps on civil and criminal penalties have been increased.  The risk of imprisonment for certain willful and knowing violations brings the TSCA in line with other environmental statutes.   
  • Rules Implementation: The TSCA Reform Act requires the EPA to develop rules to implement its processes and requirements such as those mentioned above with various policies, procedures, and guidance documents over the next one to two years.  The EPA has published a FAQ's sheet to address initially how it plans for this to occur.

The implications of TSCA reform and the EPA's expanded regulation of the manufacture and sale of chemicals will be felt by a community used to more benign oversight.  There will be an increased burden on manufacturers and processors to gather information and conduct analyses to prepare for the EPA's restrictions on chemical and toxic substances based on the risk designations.  It will now take longer for companies to introduce new chemicals into commerce because of the EPA's required affirmative determination on PMNs.  Protection of CBI, limitation of public accessibility to such information, and renewal of protective claims may oblige companies to develop stronger management of data and information produced when developing new chemicals.  In this new age of the reformed TSCA, staying abreast of the EPA's implementation of its new authority will be critical to understanding and compliance.

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.

Similar Articles
Relevancy Powered by MondaqAI
In association with
Related Topics
Similar Articles
Relevancy Powered by MondaqAI
Related Articles
Related Video
Up-coming Events Search
Font Size:
Mondaq on Twitter
Mondaq Free Registration
Gain access to Mondaq global archive of over 375,000 articles covering 200 countries with a personalised News Alert and automatic login on this device.
Mondaq News Alert (some suggested topics and region)
Select Topics
Registration (please 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.


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.


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