United States: Understanding The Re-Vamped TSCA: Federal Preemption Gives Uniform Standards

The reformed Toxic Substances Control Act (TSCA) is the first major environmental law passed since 1990. President Barack Obama signed the Frank R. Lautenberg Chemical Safety for the 21st Century Act (H.R. 2576) into law on June 22, 2016. The bill radically amends TSCA after nearly 40 years of dormancy since TSCA first become law. Chemical industry associations and manufacturers praise the revamped legislation for providing regulatory certainty that the "old" TSCA failed to provide since states were free to pass their own laws. Now, federal preemption provides uniform standards and much-needed regulatory certainty.

Business Impact The amended TSCA will have significant impacts on chemical manufacturers, importers, distributors, processors and other downstream users. Important issues include the restriction and ban of chemicals, reporting of chemical data, chemical testing, CBI claims and access, and federal preemption.

Affected companies need to understand the revised statutory concepts in the bill in order to adapt to and comply with a new U.S. regulatory framework for chemical management. In addition, the legislation has early indicators of new regulations from the U.S. Environmental Protection Agency (EPA), which will have more practical day-to-day impacts on the industry. Lastly, as EPA prioritizes, evaluates for risks, gathers chemical information, and possibly restricts individual chemicals in the upcoming months and years, affected businesses should consider participating at each stage.

Specifics of the Legislation Under the revised TSCA, EPA must evaluate new and existing chemicals against a new risk-based standard that includes considerations for vulnerable populations (such as infants, children, pregnant women, workers, or the elderly). Under this new standard, EPA must designate as a high-priority substance, a chemical substance that EPA concludes – without consideration of costs or other nonrisk factors – may present an unreasonable risk of injury to health or the environment, including an unreasonable risk to vulnerable populations. EPA now has authority to require the testing and information collection necessary to support those evaluations. Notably, the new legislation eliminates a requirement that EPA must first make a preliminary finding about risk before EPA can require testing by manufacturers or processors.

Other key changes to TSCA relate to: (1) new EPA deadlines; (2) the treatment of confidential information; (3) expanded EPA authority for funding; and (4) federal preemption of state laws.

EPA Deadlines The reform bill establishes deadlines for the review of prioritized chemicals and action on identified risks. EPA has one year after the date of enactment of the bill to issue a rule establishing the risk evaluation process. In addition, EPA has 180 days after the date of enactment of the bill to ensure that risk evaluations are conducted on 10 priority chemical substances which were drawn from a 2014 update of the TSCA Work Plan for Chemical Assessments. Not later than three-and-a-half years after the date of enactment, EPA must ensure risk evaluations are being conducted on at least 20 high-priority substances, and at least 20 chemical substances have been designated as low-priority substances. Fifty percent of all chemical substances on which risk evaluations are being conducted by EPA must be drawn from the update of the TSCA Work Plan for Chemical Assessments.

Confidential Information The bill increases the public transparency of chemical information by limiting confidentiality claims and provides further clarity on what constitutes confidential information. For instance, information relating to safety assessments and safety determinations and banned or phased-out chemicals is not considered confidential information. Manufacturers or processors of a chemical substance must substantiate their claims that certain chemical identities of chemical substances should remain confidential in accordance to a specific procedure. EPA protection of disclosure of confidential business information is limited to 10 years, with extensions of 10 years. Some confidential information may be released to states, health and environmental professionals, and first responders in emergencies.

Funding and Fees EPA's authority under the amended TSCA allows it to collect fees to carry out its new responsibilities. EPA must establish a fee on manufacturers or processors of certain chemicals to annually defray certain costs of the bill. The fee amounts are not to be "more than reasonably necessary" to defray administrative costs and will be used to cover up to 25 percent of EPA's costs. The amounts generated by the fee must be deposited in a newly established TSCA Service Fee Fund. EPA's authority to collect fees terminates 10 years after the date of enactment of the new bill.

Preemption The new legislation significantly differs from the "old" TSCA on certain preemption issues. If EPA determines a chemical substance does not present an unreasonable risk and requires no regulatory action, EPA's decision preempts state laws that may contradict that finding. EPA's preemption authority is limited to the scope of EPA's risk evaluation. Further, states may not enforce statutes or administrative actions that require the development of information that would provide the same information required under EPA.

Another key difference is the "high-priority pause," which is a limited preemption of state laws that occurs when EPA is considering whether a chemical presents an unreasonable risk. The pause goes into effect as soon as EPA begins conducting its risk evaluation. It will end on the date when EPA's deadline for completion of the risk evaluation expires, or, on the date on which EPA publishes the risk evaluation (whichever is earlier).

However, states are not stripped entirely of their power to regulate chemical substances, and certain exceptions are in place to limit the scope of federal preemption. Key provisions and amendments are as follows:

  • Any state statutory or regulatory action taken before April 22, 2016, relating to a specific chemical substance is not subject to federal preemption. Further, state action taken pursuant to a state law that was in effect on August 31, 2003, is exempted from preemption.
  • States are free to implement reporting, monitoring, or other information obligations for chemical substances not otherwise required by EPA under the revised TSCA or any other federal law.
  • States are free to enact a new requirement that is identical to a requirement prescribed by EPA without being subject to preemption.
  • States may apply for waivers from federal preemption based on certain considerations, such as "compelling conditions" that warrant granting the waiver to protect health or the environment.
  • No later than 18 months after EPA initiates the prioritization process for a chemical substance or on the date EPA publishes the scope of the risk evaluation for a chemical substance (whichever is sooner), states may enact a statute or propose or finalize an administrative action intended to prohibit or restrict the manufacture, processing, distribution in commerce, or use of a chemical substance, without being subject to preemption while EPA evaluates the chemical.

If you have any questions or would like additional information on the material covered in this Alert, please contact one of the authors or the Reed Smith lawyer with whom you regularly work.

This article is presented for informational purposes only and is not intended to constitute legal advice.

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.

In association with
Related Video
Up-coming Events Search
Font Size:
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
Confirm Password
Mondaq Topics -- Select your Interests
 Law Performance
 Law Practice
 Media & IT
 Real Estate
 Wealth Mgt
Asia Pacific
European Union
Latin America
Middle East
United States
Worldwide Updates
Check to state you have read and
agree to our Terms and Conditions

Terms & Conditions and Privacy Statement

Mondaq.com (the Website) is owned and managed by Mondaq Ltd and as a user you are granted a non-exclusive, revocable license to access the Website under its terms and conditions of use. Your use of the Website constitutes your agreement to the following terms and conditions of use. Mondaq Ltd may terminate your use of the Website if you are in breach of these terms and conditions or if Mondaq Ltd decides to terminate your license of use for whatever reason.

Use of www.mondaq.com

You may use the Website but are required to register as a user if you wish to read the full text of the content and articles available (the Content). 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 & conditions or with the prior written consent of Mondaq Ltd. You may not use electronic or other means to extract details or information about Mondaq.com’s content, users or contributors in order to offer them any services or products which compete directly or indirectly with Mondaq Ltd’s services and products.


Mondaq Ltd and/or its respective suppliers make no representations about the suitability of the information contained in the documents and related graphics published on this server for any purpose. All such documents and related graphics are provided "as is" without warranty of any kind. Mondaq Ltd and/or its respective suppliers hereby disclaim all warranties and conditions with regard to this information, including all implied warranties and conditions of merchantability, fitness for a particular purpose, title and non-infringement. In no event shall Mondaq Ltd 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 or performance of information available from this server.

The documents and related graphics published on this server could include technical inaccuracies or typographical errors. Changes are periodically added to the information herein. Mondaq Ltd and/or its respective suppliers may make improvements and/or changes in the product(s) and/or the program(s) described herein at any time.


Mondaq Ltd requires you to register and provide information that personally identifies you, including what sort of information you are interested in, for three primary purposes:

  • To allow you to personalize the Mondaq websites you are visiting.
  • To enable features such as password reminder, newsletter alerts, email a colleague, and linking from Mondaq (and its affiliate sites) to your website.
  • To produce demographic feedback for our information providers who provide information free for your use.

Mondaq (and its affiliate sites) do not sell or provide your details to third parties other than information providers. The reason we provide our information providers with this information is so that they can measure the response their articles are receiving and provide you with information about their products and services.

If you do not want us to provide your name and email address you may opt out by clicking here .

If you do not wish to receive any future announcements of products and services offered by Mondaq by clicking here .

Information Collection and Use

We require site users to register with Mondaq (and its affiliate sites) to view the free information on the site. We also collect information from our users at several different points on the websites: this is so that we can customise the sites according to individual usage, provide 'session-aware' functionality, and ensure that content is acquired and developed appropriately. This gives us an overall picture of our user profiles, which in turn shows to our Editorial Contributors the type of person they are reaching by posting articles on Mondaq (and its affiliate sites) – meaning more free content for registered users.

We are only able to provide the material on the Mondaq (and its affiliate sites) site free to site visitors because we can pass on information about the pages that users are viewing and the personal information users provide to us (e.g. email addresses) to reputable contributing firms such as law firms who author those pages. We do not sell or rent information to anyone else other than the authors of those pages, who may change from time to time. Should you wish us not to disclose your details to any of these parties, please tick the box above or tick the box marked "Opt out of Registration Information Disclosure" on the Your Profile page. We and our author organisations may only contact you via email or other means if you allow us to do so. Users can opt out of contact when they register on the site, or send an email to unsubscribe@mondaq.com with “no disclosure” in the subject heading

Mondaq News Alerts

In order to receive Mondaq News Alerts, users have to complete a separate registration form. This is a personalised service where users choose regions and topics of interest and we send it only to those users who have requested it. Users can stop receiving these Alerts by going to the Mondaq News Alerts page and deselecting all interest areas. In the same way users can amend their personal preferences to add or remove subject areas.


A cookie is a small text file written to a user’s hard drive that contains an identifying user number. The cookies do not contain any personal information about users. We use the cookie so users do not have to log in every time they use the service and the cookie will automatically expire if you do not visit the Mondaq website (or its affiliate sites) for 12 months. We also use the cookie to personalise a user's experience of the site (for example to show information specific to a user's region). As the Mondaq sites are fully personalised and cookies are essential to its core technology the site will function unpredictably with browsers that do not support cookies - or where cookies are disabled (in these circumstances we advise you to attempt to locate the information you require elsewhere on the web). However if you are concerned about the presence of a Mondaq cookie on your machine you can also choose to expire the cookie immediately (remove it) by selecting the 'Log Off' menu option as the last thing you do when you use the site.

Some of our business partners may use cookies on our site (for example, advertisers). However, we have no access to or control over these cookies and we are not aware of any at present that do so.

Log Files

We use IP addresses to analyse trends, administer the site, track movement, and gather broad demographic information for aggregate use. IP addresses are not linked to personally identifiable information.


This web site contains links to other sites. Please be aware that Mondaq (or its affiliate sites) are not responsible for the privacy practices of such other sites. We encourage our users to be aware when they leave our site and to read the privacy statements of these third party sites. This privacy statement applies solely to information collected by this Web site.

Surveys & Contests

From time-to-time our site requests information from users via surveys or contests. Participation in these surveys or contests is completely voluntary and the user therefore has a choice whether or not to disclose any information requested. Information requested may include contact information (such as name and delivery address), and demographic information (such as postcode, age level). Contact information will be used to notify the winners and award prizes. Survey information will be used for purposes of monitoring or improving the functionality of the site.


If a user elects to use our referral service for informing a friend about our site, we ask them for the friend’s name and email address. Mondaq stores this information and may contact the friend to invite them to register with Mondaq, but they will not be contacted more than once. The friend may contact Mondaq to request the removal of this information from our database.


This website takes every reasonable precaution to protect our users’ information. When users submit sensitive information via the website, your information is protected using firewalls and other security technology. If you have any questions about the security at our website, you can send an email to webmaster@mondaq.com.

Correcting/Updating Personal Information

If a user’s personally identifiable information changes (such as postcode), or if a user no longer desires our service, we will endeavour to provide a way to correct, update or remove that user’s personal data provided to us. This can usually be done at the “Your Profile” page or by sending an email to EditorialAdvisor@mondaq.com.

Notification of Changes

If we decide to change our Terms & Conditions or Privacy Policy, we will post those changes on our site so our users are always aware of what information we collect, how we use it, and under what circumstances, if any, we disclose it. If at any point we decide to use personally identifiable information in a manner different from that stated at the time it was collected, we will notify users by way of an email. Users will have a choice as to whether or not we use their information in this different manner. We will use information in accordance with the privacy policy under which the information was collected.

How to contact Mondaq

You can contact us with comments or queries at enquiries@mondaq.com.

If for some reason you believe Mondaq Ltd. has not adhered to these principles, please notify us by e-mail at problems@mondaq.com and we will use commercially reasonable efforts to determine and correct the problem promptly.