Bergeson & Campbell, P.C. (B&C®) is a Washington, D.C. law firm providing chemical and chemical product stakeholders unparalleled experience, judgment, and excellence in matters relating to TSCA, and other global chemical management programs.

By Richard E. Engler, Ph.D. and Margaret R. Graham

On November 22, 2017, the U.S. Environmental Protection Agency (EPA) announced it was releasing a preliminary list of chemical substances reported under the Toxic Substances Control Act (TSCA) Inventory Notification (Active-Inactive) rule that includes substances reported to EPA through November 10, 2017, and that it will be updated approximately once per month.  EPA states that it is making this list available to help keep the stakeholder community informed of the status of reporting under the TSCA Inventory Notification (Active-Inactive) rule.  EPA is providing the list in a downloadable, searchable spreadsheet.  The total number of chemicals on the list is 10,730.  

This total adds substantially to the 13,209 substances that appear on EPA’s list of substances exempt from Form A reporting.  It is important to note that the new list is not an update to the list of interim active substances or to the list of substances exempt from Form A reporting; it is only a list of substances reported via Form A notices of activity through the specified date.  The new list of substances reported by Form As will be useful to processors, allowing them to ensure that key substances are reported as active, but it does not relieve manufacturers or importers from the Form A reporting obligations of the rule.

More information on the TSCA Inventory Notification (Active-Inactive) rule is available on our blog item under key phrase TSCA Inventory


 

By Lynn L. Bergeson and Margaret R. Graham

On September 20, 2017, the U.S. Environmental Protection Agency (EPA) issued a notice in the Federal Register stating that it is extending the compliance date by which submitters of Toxic Substances Control Act (TSCA) submissions containing information claimed as Confidential Business Information (CBI) and filed between June 22, 2016, and March 21, 2017, had to submit to EPA the substantiation required by TSCA Section 14(c)(3) for all information claimed as confidential, other than information exempt from substantiation pursuant to TSCA Section 14(c)(2).  82 Fed. Reg. 43964.  The new deadline for substantiation of these claims is October 19, 2017.  EPA states that this extension is in response to “concerns raised by industry stakeholders regarding the ability for companies to meet the previous September 19, 2017, deadline due to recent severe weather events,” and that it is “providing this additional flexibility for stakeholders because of the impacts of hurricanes Harvey and Irma.”  Further, “because EPA published its interpretation that TSCA section 14(c)(3) requires up front substantiation after some companies had already asserted confidentiality claims subject to TSCA section 14(c)(3), the Agency set a future deadline for submission of substantiations pertaining to those submissions.” 

More information on the CBI substantiation process is available in our memorandum The September 19th CBI Substantiation Deadline Fast Approaching.

Also on September 20, 2017, EPA announced it was scheduling three webinars to assist the regulated community with reporting under the TSCA Inventory Notification (Active-Inactive) rule.  The webinars, scheduled for September 27, 2017, October 25, 2017, and November 29, 2017, from 1:00 p.m. - 3:00 p.m. (ET), will be identical and will include an overview of reporting requirements, a demo of the electronic reporting application (Central Data Exchange (CDX)), and will provide time for questions and answers.  Registration for the webinars is not required.  EPA’s TSCA Inventory webpage contains the information on how to access the webinar.

More information on the TSCA Inventory Notification (Active-Inactive) rule is available in our memorandum EPA Issues Final TSCA Framework Rules.


 

By Lynn L. Bergeson and Margaret R. Graham

On September 1, 2017, the Environmental Defense Fund (EDF) filed a petition for review in the U.S Court of Appeals for the D.C. Circuit (No. 17-1201) of the U.S. Environmental Protection Agency’s (EPA) final Toxic Substances Control Act (TSCA) framework rule TSCA Inventory Notification (Active-Inactive) Requirements, published on August 11, 2017 (82 Fed. Reg. 37520). 

This is the third and final challenge by EDF to the framework rules implementing amended TSCA (there are only three framework rules), but the seventh total challenge, as other parties have also petitioned for review.  On August 11, 2017, EDF petitioned for review of the TSCA framework rules Procedures for Chemical Risk Evaluation under TSCA and the final rule Procedures for Prioritization of Chemicals for Risk Evaluation, filed on August 11 (Second Cir. Case Nos. 17-2464 and 17-2403, respectively).  Per the Consolidation Orders of the United States Judicial Panel on Multidistrict Litigation, both of EDF’s August 11 petitions have now been consolidated with other petitions for review of the same orders.  Case No. 17-2464 was moved to the Fourth Circuit, and Case No. 2403 was moved to the Ninth Circuit. 

In the Fourth Circuit, the opening brief, record from agency, and the appendix are due September 20, 2017, and the response brief is due October 20, 2017.  In the Ninth Circuit, the Petitioners’ briefs are due October 30, 2017, and Respondent EPA’s briefs are due November 28, 2017.                                       


 

By Lynn L. Bergeson and Margaret R. Graham

On August 11, 2017, the U.S. Environmental Protection Agency (EPA) published the third Toxic Substances Control Act (TSCA) framework final rule in the Federal Register, the TSCA Inventory Notification (Active-Inactive) Requirements.  This final rule is effective as of August 11, 2017 (the date of publication).

As further detailed in the final rulemaking, chemical manufacturers and importers are required to submit notifications for chemicals that were manufactured or imported over the ten year look-back period of June 21, 2006, to June 21, 2016.  Pursuant to the rulemaking, the retrospective reporting period for manufacturers begins on August 11, 2017, and ends on February 7, 2018.  The submission period for processors also begins on August 11, 2017, but processors have until October 5, 2018, to submit retrospective activity notifications.

More information on the final rule is available in our memorandum EPA Issues Final TSCA Framework Rules.


 

By Lynn L. Bergeson and Margaret R. Graham

On August 11, 2017, the U.S. Environmental Protection Agency (EPA) is scheduled to publish the third Toxic Substances Control Act (TSCA) framework final rule in the Federal Register, the TSCA Inventory Notification (Active-Inactive) Requirements.  This final rule is scheduled to become effective on August 11, 2017 (the date of publication).

This rule, signed by EPA on June 22, 2017, establishes, among other requirements:

  • A retrospective electronic notification of chemical substances on the TSCA Inventory that were manufactured (including imported) for nonexempt commercial purposes during the ten-year time period ending on June 21, 2016, with provision to also allow notification by processors;
  • Procedures for forward-looking electronic notification of chemical substances on the TSCA Inventory that are designated as inactive, if and when the manufacturing or processing of such chemical substances for nonexempt commercial purposes is expected to resume; and
  • Procedures regarding the manner in which such retrospective and forward-looking activity notifications must be submitted, the details of the notification requirements, exemptions from such requirements, and procedures for handling claims of confidentiality.

More information on this final rule is available in our memorandum EPA Issues Final TSCA Framework Rules.  


 

By Lynn L. Bergeson

On March 15, 2017, the U.S. Environmental Protection Agency (EPA) announced it would be extending the comment period on the Toxic Substances Control Act (TSCA) Inventory Notification (Active-Inactive) proposed rule issued on January 13, 2017.  On March 16, 2017, however, EPA rescinded this extension, stating it was issued in error, but did state that it would “make every effort to consider comments received outside of the formal comment period, if provided by March 24, 2017.”  EPA is accepting comments in Docket ID EPA-HQ-OPPT-2016-0426 on the www.regulations.gov website.  More information on this proposed rule is available in our memorandum EPA Proposes Requirements for TSCA Inventory Notification (Active-Inactive).


 

By Lynn L. BergesonCarla N. Hutton, Charles M. Auer, and Richard E. Engler, Ph.D.

The U.S. Environmental Protection Agency (EPA) is scheduled to publish a proposed rule on January 13, 2017, that would require a retrospective electronic notification of chemical substances on the Toxic Substances Control Act (TSCA) Inventory that were manufactured (including imported) for non-exempt commercial purposes during the ten-year time period ending on June 21, 2016.  EPA would also accept such notices for chemical substances that were processed.  The recent TSCA amendments require EPA to designate chemical substances on the TSCA Inventory as either “active” or “inactive” in U.S. commerce.  EPA states in the pre-publication version of the proposed rule that it would use these notifications to distinguish active substances from inactive substances.  EPA would include the active and inactive designations on the TSCA Inventory and as part of its regular publications of the Inventory.  EPA also proposes to establish procedures for forward-looking electronic notification of chemical substances on the TSCA Inventory that are designated as inactive, if and when the manufacturing or processing of such chemical substances for non-exempt commercial purposes is expected to resume.  According to the proposed rule, upon receipt of a valid notice, EPA would change the designation of the pertinent chemical substance on the TSCA Inventory from inactive to active.  The proposed rule includes the procedures to submit retrospective and forward-looking activity notifications, the details of the notification requirements, exemptions from such requirements, and procedures for handling claims of confidentiality.  Publication of the proposed rule will begin a 60-day comment period.  More information on the final rule will be available in our forthcoming memorandum, which will be available on our website under the key phrase TSCA.


 

By Lynn L. Bergeson and Richard E. Engler, Ph.D.

On September 12, 2016, Chemical Watch and Bergeson & Campbell, P.C. (B&C®) presented the third webinar in “The New TSCA:  What You Need To Know” webinar series:  “Webinar 3:  Inventory, CDR, and CBI (Sections 8 & 14).”  This webinar provided insight and information regarding Toxic Substances Control Act (TSCA) reform as it is being enacted and implemented, specifically related to Sections 8 and 14 of the reformed TSCA, which included the TSCA Inventory, chemical data reporting (CDR), and confidential business information (CBI).  Companies and trade groups who could not participate in the webinar can contact .(JavaScript must be enabled to view this email address) to request a recording and copy of the presentation slides.

The topics from Section 8 of TSCA, regarding reporting and retention of information, included:  Small Manufacturer Definition; Reporting by Processors; Inorganic Byproduct Rulemaking and Reporting; TSCA Inventory; and Nomenclature.  The key points from this portion included:

  • The sales thresholds for small manufacturers are likely to rise from the current level that was set in 1986;
  • TSCA Inventory “reset” will require companies to report for substances manufactured or imported in the last 10 years and there will be no exemptions for polymers or low volume substances;
  • EPA may impose different requirements for CDR reporting by manufacturers and processors;
  • EPA must enter into negotiated rulemaking to reduce CDR reporting for recycling and reprocessing inorganic byproducts; and
  • Interested parties should be aware of rulemaking on these issues as well as rules that EPA will be promulgating to implement other sections of TSCA. 

The topics from Section 14 of TSCA, regarding CBI, included:  Information Not Protected; Asserting CBI; Presumptive CBI; Requirements for CBI Claims; Exemptions to Protection from Disclosure; Review and Resubstantiation; Duties of Administrator; and Criminal Penalties.  The key points from this portion included:

  • Most CBI claims made prior to enactment of TSCA reform will not require substantiation, but claims going forward, including chemical identity for substances notified as “active” on the TSCA Inventory will require substantiation;
  • EPA must review all CBI claims for chemical identity;
  • CBI protection that requires substantiation will sunset after ten years; claimants may reassert and resubstantiate claims to continue protection for another ten year period;
  • EPA must disclose CBI upon request from state, municipal, and tribal officials who demonstrate the need for the information and agree to protect CBI;
  • EPA must also disclose CBI upon request from medical professionals if it is reasonable to believe the information is necessary to treat a patient; and
  • In most cases, EPA will notify CBI claimants prior to disclosing CBI to persons that are not federal employees or federal contractors.

The panel speakers were, from B&C: Charles M. Auer, Senior Regulatory and Policy Advisor, former Director of the Office of Pollution Prevention and Toxics (OPPT), U.S. Environmental Protection Agency (EPA); Lynn L. Bergeson, Managing Partner; Richard E. Engler, Ph.D., Senior Chemist, former senior staff scientist in OPPT and leader of EPA's Green Chemistry Program; and Kathleen M. Roberts, Vice President, B&C Consortia Management, L.L.C.; and from Chemical Watch:  Kelly Franklin, North America Reporter & Editor.

The fourth and final webinar in the series, “Other Provisions -- PBTs, Preemption, and Green/Sustainable Chemistry” will be presented on September 27, 2016.