United States: Two Recent EPA Announcements Can Have Unexpected Consequences

Last Updated: July 22 2019
Article by Lawrence E. Culleen

The US Environmental Protection Agency (EPA) has been on an incredible roll during the past two years; publishing countless regulatory actions, framework rules, and operating policies that have enabled the agency to consistently meet the daunting deadlines imposed by the sweeping 2016 amendments to the Toxic Substances Control Act (TSCA). Chemical manufacturers, importers, processors, and users should pay close attention to two recent EPA announcements because the failure to appreciate their implications can have significant adverse consequences. The two announcements are: (1) the publication of a proposed rule that would regulate the production and use of four substances EPA considers to be persistent, bioacculmulative, toxic (PBT) chemicals as well as manufactured products that contain any one of these substances and (2) the announcement of a change in EPA's procedure for handling documents it receives which contain confidential business information (CBI).

The PBT rule. On the third anniversary of enactment of the 2016 amendments to TSCA, the agency announced its proposed TSCA Section 6 rule intended to reduce exposures to four substances EPA had determined in the fall of 2016 to be candidates for so-called "expedited' rulemaking. The substances are assessed by EPA to be persistent, bioaccumulative and toxic and, by implication, to potentially present risks for exposed populations including the general population, consumers and commercial uses, as well as certain susceptible subpopulations (such as workers, subsistence fishers, members of Native American tribes, and children). The amended Section 6(h) of TSCA requires EPA to propose such a rule no later than June 22, 2019 "to address the risks of injuries to health or the environment . . . and to reduce exposures to the substance to the extent practicable."  The final rule must follow no more than 18 months later (i.e., late December 2020). The four substances identified for risk mitigation actions in the proposed rule are:

  • Decabromodiphenyl ether (DecaBDE);
  • Phenol, isopropylated phosphate (3:1) or PIP (3:1);
  • 2,4,6-tris(tert-butyl)phenol (2,4,6-TTBP); and
  • Pentachlorothiophenol (PCTP).

Hexachlorobutadiene (HCBD) has been evaluated by EPA and the agency has announced it did not identify any practicable ways of further reducing human or environmental exposure to that substance. (HBCD is already regulated by EPA as a hazardous air pollutant under the Clean Air Act.) The proposed PBT rule prohibits the import or manufacture of the substances for specific uses and includes recordkeeping requirements for several of the chemicals and downstream notification requirements for one chemical. Read more about the rulemaking.

Important, and Often Overlooked, Implications of Proposed TSCA Section 6 Rules. Businesses in the US that export (or later develop the intent to export) products that contain any substance subject to a proposed Section 6 regulation must provide advance notification to EPA of export shipments containing even small concentrations of the substances. This requirement is imposed by operation of law when certain TSCA regulatory actions are barely commenced because Section 12(b) of TSCA requires any person who exports or intends to export a chemical substance or mixture subject to certain proposed TSCA regulations to notify EPA of the export activities.1 (EPA is expected to provide information about the exported chemical and EPA's related regulatory actions to the government of the destination country.) Because for the preceding 40 years, EPA has proposed very few TSCA Section 6 rules, not many companies fully appreciate that TSCA Section 6 rules are among those which trigger commencement of the export notification requirements when such a rule is merely proposed.2

To complicate matters, the export notification obligation does not apply solely to exports of bulk chemicals. The Section 12(b) obligation also applies to commercial and consumer products comprised of mixtures and solutions incorporating even small quantities of a regulated substance. Thus, an entity that exports a product that contains measurable quantities of decaBDE; PIP (3:1); 2,4,6-TTBP; or PCTP must determine as soon as possible whether it must provide notice to EPA of its export shipments.3  For substances or mixtures subject to TSCA Section 6 actions, exporters must notify EPA of the first export within each calendar year of export on a per chemical, per country basis. Moreover, export notices must be postmarked within seven days of forming the intent to export or on the date of export, whichever is earlier. Notification of export generally is not required for manufactured "articles" that contain one of the regulated substances  or those which contain the substance at levels below specified de minimis concentrations.4

New TSCA CBI Procedure. EPA has long-standing procedures concerning the identification, handling and storage of commercially sensitive information. Among the agency's more helpful and constructive practices has been notifying an entity that has asserted a CBI claim for a particular document when EPA has determined the manner in which the claim has been asserted and/or substantiated is deficient. A "deficiency" notice typically gave the recipient 30 days during which to perfect (typically the need to substantiate) its claim.

EPA appears to have abandoned that helpful practice and to be taking a more ruthless approach to instances in which an entity has failed to properly substantiated CBI claims. 

On July 16, 2019 EPA published a Federal Register notice announcing the agency will, commencing August 15th, stop sending notices of deficiency to businesses whose submissions do not meet all the statutory requirements. Read the Federal Register notice announcing this change. Instead, the agency will provide written notice to affected document submitters that because they submitted procedurally flawed CBI claims, including unsubstantiated CBI claims, those claims will be considered "invalid," and the underlying information will not be protected from disclosure under TSCA Section 14.

Unlike the notice of deficiency, the written notice EPA intends to provide going forward will not provide the affected business 30 calendar days to remedy their deficient CBI claims. Rather, the written notice will inform the entity that their procedurally-flawed CBI claims may be disclosed to the public without further notice (presumably, in response to a FOIA request or other circumstances).

On January 19, 2017, EPA announced it interprets the 2016 amendments to Section 14 to require that entities that want to protect information they submit from public disclosure must assert the claim for CBI protection concurrent with submission of the information, and provide "up front" substantiation of the claim.

The implications of this policy change could be staggering. If an entity inadvertently fails to enclose the full substantiation for its CBI claims at the time the information is provided to EPA (or an EPA staff person potentially has inadvertently lost or mislaid the substantiation document which the entity timely submitted), EPA could simply make the information claimed as CBI available to the general public and the entity's competitors. While the failure to assert a CBI claim does not lead to the potential liability for "violating" TSCA, the potential loss of control over valuable intellectual property and the company's competitive advantage nevertheless could be devastating to the business. For further information on how to timely assert and substantiate CBI claims, see Confidential Business Information under TSCA.

Summary. Recent and even seemingly routine announcements by EPA should be considered carefully by the regulated community to determine whether and how they could adversely affect your company's business. Be sure to follow our quarterly newsletter, The Chemical Compound, to keep current on regulatory, legislative and litigation developments of importance to your business.

  1. The export notification obligation arises for exporters of substances for which: The submission of data is required under TSCA sections 4 or 5(b); An order has been issued under TSCA section 5; A rule has been proposed or promulgated under TSCA sections 5 or 6; or An action is pending, or relief has been granted under TSCA sections 5 or 7.
  2. It is worth noting that EPA also proposed Section 6(a) regulations for Methylene Chloride, Trichloroethylene (TCE), andN-Methylpyrrolidone (NMP) prior to the inauguration of the Trump administration and has issued the Methylene Chloride regulation in final form earlier this year.
  3. At least one of the PBT substances, decaBDE, previously was subject to a proposed Significant New Use Rule, however, this announcement of the Section 6 PBT rule will change the frequency with which Section 12(b) notices must be given to EPA.
  4.  See 40 CFR 707.60(b) and 40 CFR 707.60(c). Because the proposed PBT regulation also addresses articles containing the substances in certain respects, the PBT rule proposal creates certain ambiguity in this regard.

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