United States: 10 Key Revisions To EPA's Final TSCA Inventory Reset Rule: Trump Administration Provides Some Regulatory Relief

The US Environmental Protection Agency (EPA) has issued its final regulation governing the update of the nearly forty-year-old Toxic Substances Control Act (TSCA) list (the Inventory) of chemical substances manufactured, imported, or processed in the United States (TSCA Inventory Reset Rule).1 This advisory summarizes ten of the key differences between EPA's final and proposed TSCA Inventory Reset Rule that collectively should reduce entities' regulatory burden, although the extent of this regulatory relief will vary widely within the regulated community.


In 2016, Congress amended TSCA to, among other things, require EPA to (1) designate chemical substances on the Inventory as either "active" or "inactive" in US commerce; and (2) issue a final regulation by June 22, 2017 establishing the process by which manufacturers, importers, and processors must provide EPA the information needed to update the Inventory in this manner. The final TSCA Inventory Reset Rule follows the same general approach as the proposed rule about which we have previously written.

In brief, the final Rule imposes two new reporting requirements on chemical substance manufacturers, importers, and processors (e.g., companies that purchase and use chemical substances to blend or formulate other products that are distributed in U.S. commerce). First, the Rule requires "retrospective" reporting to confirm which substances have been "active" in US commerce at any time between June 21, 2006, and June 21, 2016 (the "lookback period"). Active substances include not only substances that have been manufactured in (or imported to) the US during that period, but also substances that were processed in the US at any time during that 10-year period. Such substances, once properly reported, will be placed on the "active" portion of the Inventory.

Second, for any substance that is not on the active portion of the Inventory, the Rule requires entities to provide "forward-looking" reports of the re-commencement of manufacturing or processing of such substances. If a chemical is placed on the "inactive" portion of Inventory, the continued manufacture (including import) or processing of the chemical in the United States for a nonexempt commercial purpose would be unlawful, unless a "forward-looking" report is provided to the EPA no more than 90 days before the anticipated date of resuming manufacturing (including importing) or processing of the substance. (Substances which do not appear on the Inventory at all are considered "new" chemical substances for which a different document, a pre-manufacture notification, must be provided to EPA before manufacture may commence for any non-exempt commercial purpose.)

The final TSCA Inventory Reset Rule seeks to efficiently manage a daunting task. The non-confidential portion of the Inventory included more than 67,000 substances as of January 2017,2 with tens of thousands more presumably on the confidential portion of the Inventory (listing substances the manufacturer or importer has asserted a confidential business information (CBI) claim). Businesses from across the country large and small will need to ensure that the substances they have used within the ten year lookback period that they either continue to manufacture, import, or process or plan to do so in the future are placed on the active portion of the TSCA Inventory to avoid any business disruptions and legal consequences from having a substance designated "inactive." EPA's initial list contains over 9,600 "active" substances based on the 2012 and 2016 CDR reports and Notices of Commencement (NOCs) filed during the ten-year lookback period and is available here.


Below are ten of the key revisions to the final TSCA Inventory Reset Rule that should provide some regulatory relief to entities seeking to comply with the Rule.

1. Both non-CBI and  CBI Substances Reported During the 2012 and 2016 CDR Reporting Cycles Are Exempt from Retrospective Reporting, If Entities Are Willing to Risk Waiving Existing CBI Claims.

In the proposed TSCA Inventory Reset Rule, EPA proposed that only those "substances on the non-confidential portion of the Inventory would be from reporting if" the substances were reported by any party in response to the 2012 or 2016 chemical data reporting (CDR).3 In response to numerous comments, EPA expanded the scope of this exemption to include substances with chemical identities claimed as CBI (CBI substances) listed on the confidential portion of the Inventory.4 Accordingly, under the final TSCA Inventory Reset Rule for substances on the non-confidential portion of the Inventory (non-CBI substances) and CBI substances, a manufacturer, importer, or processor need not submit retrospective reports. Importantly, however, an entity still must submit a retrospective report for CBI substances if it wants to maintain its CBI claim for a substance's specific chemical identity.5 Failure to do so would result in EPA moving the CBI substance "to the non-confidential portion of the Inventory," making the specific chemical identity public.

The practical effect of this revision is that it provides relief to "a company, which had previously sought a CBI claim for a specific chemical identity, [but] may no longer view the CBI status as necessary or currently defensible"—i.e., companies that are willing to drop their CBI claim.6 Companies that want to maintain their CBI claim must still file retrospective reports. (New CBI claims for the specific identity of a substance already listed on the public Inventory may not be asserted in Inventory reset reports.) Based on EPA's initial list of over 9,600 "active" substances compiled from the 2012 and 2016 CDR reports and Notices of Commencement (NOCs) filed during the ten-year lookback period, approximately 820 are CBI substances for which retrospective reports are necessary, unless the CBI claim is to be waived.7

2. Substances with a Notice of Commencement Filed During the Lookback Period Also Are Exempt from Retrospective Reporting, but CBI Claims Should be Reasserted.

In response to comments, EPA also has revised the final TSCA Inventory Reset Rule to exempt from retrospective reporting those substances for which a NOC was filed with EPA during the ten-year lookback period. EPA reasoned that "[r]equiring retrospective reporting" of such substances "would be duplicative because EPA already has an equivalent report (the NOC itself) indicating that the substance was manufactured or processed during the lookback period."8 This exemption applies to substances that are manufactured or imported below the CDR report reporting volume thresholds, and therefore may not have been included in the 2012 or 2016 CDR reports. Accordingly, under the final Rule, relatively small volume substances for which a NOC was filed during the lookback period may be exempt from retrospective reporting, whereas they were not under the proposed rule.

As with the exemption noted for substances reported for the 2012 and 2016 CDR rules, an entity would be well advised to submit a retrospective report for a substance listed on the confidential portion of the Inventory to have certainty it will be able to maintain its claim for specific chemical identity, regardless of whether the substance was the subject of a NOC during the lookback period.9

3. EPA Adds Exemptions from Retrospective Reporting Substances Manufactured, Imported, or Processed Under the Existing PMN Exemptions for Test Marketing and Substances Manufactured or Processed Solely for Export.

TSCA Section 5 requires manufacturers, importers, or processors of new substances that are not on the Inventory to file a pre-manufacture notice (PMN). There are numerous exemptions to this PMN requirement (PMN exemptions). In the final TSCA Inventory Reset Rule, EPA confirmed that a substance manufactured, imported, or processed under a PMN exemption "and not listed on the Inventory" "is not subject to reporting under this" Rule.10

Some ambiguity arises for an entity that relies on a PMN exemption to manufacture for exempt purposes, but the substance nonetheless appears on the Inventory due to a listing sought by another entity who did not rely on the PMN exemption. In the proposed Rule, EPA exempted only those substances that met one of the following PMN exemptions: (1) small quantities for research and development; (2) imported as part of an article; and (3) those listed in 40 C.F.R. § 720.30(g) and (h). EPA retained these exemptions in the final Rule and added two more PMN exemptions: (4) "manufacturing or processing of a chemical substance solely for test marketing purposes;" and (5) "manufacturing or processing of a chemical substance solely for export from the United States as described in § 720.30(e) or § 721.3, except where" EPA has made an unreasonable risk finding under TSCA Section 12(a)(2).11

EPA declined, however, to add the so-called polymer exemption and the low release/low exposure exemption, contending that these exemptions "are predicated upon a risk determination," rather than the view that the activity at issue did not constitute commercial activity.12 The practical effect of this position is that, if (for example) an entity's exempt polymer also appears on the Inventory (because another company submitted a PMN for the polymer), the entity may want to file a retrospective report to ensure its polymer is not placed on the "inactive" portion of the Inventory, even if the entity continues to satisfy the polymer PMN exemption. More broadly, any entity that has relied upon one of the PMN exemptions for their substance will want to review the Inventory to determine whether such a substance is on the Inventory, and therefore whether it is at risk of being moved to the "inactive" portion if a retrospective report is not filed.

4. EPA Reduces the Amount of Information That Must Be Reported.

The final TSCA Inventory Reset Rule no longer requires entities to provide in their retrospective reports either: (1) a date range during which the substance was manufactured or imported; or (2) the type of activity (i.e., whether it was manufactured, imported, or processed).13 Instead, entities must simply affirm in the retrospective report that the substance was manufactured, imported, or processed at some time during the ten-year lookback period. Similarly, the forward-looking reports need not indicate the type of activity contemplated.14 These revisions should reduce entities' burden and expense of reviewing records to determine, for example, the precise start and stop dates of manufacturing, importing, or processing a substance—a task that would have been especially burdensome for substances manufactured, imported, or processed episodically or at the beginning of the lookback period. Companies may nonetheless still face challenges locating information required under the final Rule, including those companies that have undergone mergers and acquisitions within or after the lookback period.

5. EPA Adds Flexibility to the Time Period within which Forward-Looking Reports Must Be Submitted.

Under the proposed TSCA Inventory Reset Rule, EPA provided that entities must file their forward-looking reports no "more than 30 days before the actual date of manufacturing or processing."15 In the final Rule, EPA relaxed this deadline in two respects. First, entities must submit the forward-looking report reporting "the anticipated date of reintroduction of a chemical substance in US commerce, rather than the actual date.";16 EPA explained that this revision was necessary because reporting "in advance of actual commercialization is based on information and schedules that are subject to change, and providing an actual date of commercialization in advance, therefore, is not always practical."17 Second, instead of 30 days in advance, EPA extended the submission window to up to 90 days before the anticipated date of reintroducing the substance into US commerce.18

6. EPA Delays Effective Date for "Inactive" Designations By 90 Days

The final TSCA Inventory Reset Rule provides a 90 day grace period after EPA issues its "active" and "inactive" designations before forward-looking reports must be submitted. The Rule accomplishes this by delaying the effective date of the inactive designations by 90 days.19 Therefore, rather than risk having EPA unexpectedly declare an important raw material to be inactive upon publication of the final updated Inventory (and potentially rendering an entity in immediate non-compliance if it continued to manufacture, import, or process the substance), such an entity will now have 90 days to review the final "inactive" list and file a forward-looking report for any "inactive" substances. This will enable the entity to continue to manufacture, import, or process the substance uninterrupted.

7. Grace Period Within Which to Withdraw or Revise a Retrospective or a Forward-Looking Report Without Penalty.

EPA also added two grace periods within which submitters may withdraw or revise their reports without penalty. First, EPA will allow retrospective reporting notices submitted by manufacturers, importers, or processors "to be withdrawn not later than 420 days after the publication of the final rule in the Federal Register."20 Second, submitters may withdraw a forward-looking report "if EPA has not yet altered the Inventory status of the chemical substance in response to the original submission (i.e., EPA has neither redesignated the substance from inactive to active nor moved the substance from the confidential portion of the Inventory to the public portion of the Inventory as a result of a request in the original submission for a CBI claim to be withdrawn)."21

If the reports are not withdrawn during these periods, the filing of the "incorrect information would be considered a prohibited act under [TSCA] Section 15(1) and 15(3)."22 EPA advises entities making corrections after these grace periods should avail themselves of EPA's Self-Disclosure policies and timely and voluntarily disclose the violation.23

8. EPA Further Extends Processors' Deadline to File Retrospective Reports to 420 Days.

EPA added another 60 days to the proposed deadline for processors to file retrospective reports, increasing the deadline for processors' retrospective reports to 420 days after the final Rule is issued.24 That said, unlike manufacturers or importers, processors do not need to file retrospective reports. Instead, they may wait to see if the substances on which they rely are placed on the "inactive" list and, if so, then provide a forward-looking notice within the 90 day window to ensure processing of the substance lawfully may continue. We have written previously here regarding the challenge facing processors under this Rule.

9. Entities Need Not File a Retrospective Report If They Have a Specific Form of Evidence That Another Entity Has Filed Such A Report for the Same Substance.

Under the proposed TSCA Inventory Reset Rule, EPA required each manufacturer or importer of a substance to file a retrospective report (unless otherwise exempt) regardless of whether another entity also filed a retrospective report for the same substance.25 Several commentators urged EPA to publish frequent or "real time" updates to the "active" and "inactive" lists based on the retrospective reports EPA receives and to exempt manufacturers and importers from having to file duplicative reports if EPA already had received one.26 Although EPA declined to commit to making "real time" or frequent updates to the list out of feasibility concerns,27 it did exempt manufactures and importers from having to file a retrospective report for a substance if they have "evidence in the form of a CDX receipt, document EPA's receipt of a [retrospective report] from another manufacturer."28

This may provide some relief to a small subset of manufacturers and importers, but in reality few entities likely will avail themselves of this exemption due to a combination of several factors, including: (1) the practical difficulties of obtaining a CDX receipt from another manufacturer or importer of the same substance (and potentially a competitor); (2) the reduced amount of the information EPA now requires be submitted in a retrospective report; and (3) as EPA identified in the final Rule, by not submitting the retrospective report, an entity runs the risk that the submitter will withdraw the report and the substance will be moved to the inactive list.29 However, processors may begin to request certification of compliance from their suppliers, including copies of the CDX receipts.

10. EPA Has Pre-Populated Its Electronic Reporting System with CBI Substances and Non-CBI Substances On the Inventory.

To expedite the submission of retrospective reports, "EPA expanded its electronic reporting system to include a pick list from which persons can select chemicals for reporting."30 "The pick list will include only reportable substances and will not include the specific chemical identities of CBI substances. Non-CBI substances will be listed by CASRNs and CA index names, as they appear on the Inventory, and CBI substances will be listed by EPA accession numbers and generic names, as they appear on public versions of the Inventory."31 This pre-populated list also may assist importers and processors who may not always know a substances' specific chemical identity and instead must rely upon the publicly available information provided to them by their supplier (e.g., EPA accession numbers; generic name).


EPA's stated intention has been to revise the final TSCA Inventory Reset Rule in part to provide some relief to regulated entities. The precise amount of relief experienced will likely vary for each manufacturer, importer, and processor of chemical substances affected by this Rule. Regardless, it remains the case that such entities must pay close attention to EPA's TSCA Inventory Reset Rule and EPA's active and inactive designations (both interim and final) to protect their existing CBI claims and their ability to continue to manufacture, import, and process chemical substances in US commerce.


1. As of the date of this advisory, the final TSCA Inventory Reset Rule was not yet printed in the Federal Register. See EPA's pre-publication version of the final TSCA Inventory Reset Rule.

2. EPA, How to Access the TSCA Inventory

3. TSCA Inventory Notification (Active-Inactive) Requirements. 82 Fed. Reg. 4,255, 4,259 (Jan. 13, 2017) (proposed rule).

4. Pre-Publication Version at 34 - 35.

5. Id.at 35.

6. Id.("In such circumstance, the company may take advantage of any retrospective reporting exemption for which it is eligible, and decline to submit a retrospective notice to EPA.").

7. EPA, Interim List of Active Substances

8. Pre-Publication Version at 36.

9. Id.at 37.

10. Id.at 28 (emphasis added).

11. Id.at 29.

12. Id.at 30.

13. Id.at 49 - 50

14. Id.at 50.

15. TSCA Inventory Notification (Active-Inactive) Requirements. 82 Fed. Reg. 4,255, 4,260 (Jan. 13, 2017) (proposed rule).

16. Pre-Publication Version at 43.

17. Id.

18. Id.at 43 - 44.

19. Id.at 48.

20. Id.at 56.

21. Id.at 57.

22. Id.;see also15 U.S.C § 2614 ("It shall be unlawful for any person to— (1) fail or refuse to comply with any requirement of this subchapter or any rule promulgated, order issued, or consent agreement entered into under this subchapter, or any requirement of subchapter II or any rule promulgated or order issued under subchapter II" . . . "(3) fail or refuse to (A) establish or maintain records, (B) submit reports, notices, or other information, or (C) permit access to or copying of records, as required by this chapter or a rule thereunder").

23. Pre-Publication Version at 57.

24. Id.at 42.

25. TSCA Inventory Notification (Active-Inactive) Requirements. 82 Fed. Reg. 4,255, 4,267 (Jan. 13, 2017) (proposed rule).

26. Pre-Publication Version at 39.

27. Id.at 38.

28. Id.at 40.

29. Id.

30. Id.at 58 - 59 ("Submitters can identify substances from the pick list and, therefore, do not have to manually enter chemical identity information.").

31. Id.at 58.

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.

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.


From time to time Mondaq may send you emails promoting Mondaq services including new services. You may opt out of receiving such emails by clicking below.

*** If you do not wish to receive any future announcements of services offered by Mondaq you may opt out by clicking here .


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.