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 Lynn L. Bergeson, Richard E. Engler, Ph.D., and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) published a Federal Register notice on May 15, 2019, announcing the availability of a signed action identifying chemical substances for inactive designation according to the Toxic Substances Control Act (TSCA) Inventory Notification (Active-Inactive) Requirements rule.  84 Fed. Reg. 21772.  The signed action, dated May 6, 2019, initiated a 90-day period after which substances identified as inactive will be designated as inactive.  Inactive designations for chemical substances on the TSCA Chemical Substance Inventory are effective on Monday, August 5, 2019.  Beginning August 5, 2019, manufacturers and processors will be required to notify EPA before reintroducing into commerce a substance currently identified as inactive on the TSCA Inventory.  Manufacturers and processors can notify EPA via a Notice of Activity (NOA) Form B, found in EPA’s Central Data Exchange (CDX).  Upon receiving such notification, EPA will change the designation of substances from inactive to active.  Our July 31 2019, memorandum, “EPA Posts NOA Form B Materials before TSCA Inventory Inactive Designations Take Effect August 5,” provides links to EPA materials intended to help manufacturers and processors prepare for the inactive designations taking effect, as well as a detailed commentary.  Companies with additional questions should contact .(JavaScript must be enabled to view this email address) or .(JavaScript must be enabled to view this email address)., for assistance.


 

By Lynn L. Bergeson and Margaret R. Graham, M.S.

On May 9, 2019, the U.S. Environmental Protection Agency (EPA) announced that it would soon be making available a signed action signed on May 6, 2019, that identifies chemical substances for inactive designation according to the Toxic Substances Control Act (TSCA) Inventory Notification (Active-Inactive) Requirements rule.  The pre-publication version of the notice is available here.  Specifically, EPA states that the signed action is a companion to the first version of the TSCA Chemical Substance Inventory with all listings designated as active or identified as inactive, which was posted on the EPA TSCA Inventory web page on February 19, 2019, and it will initiate a 90-day period after which substances identified as inactive will be designated as inactive.  Because the action was signed on May 6, 2019, inactive designations will become effective on Monday, August 5, 2019.  

Starting on August 5, 2019, manufacturers and processors are required to notify EPA before reintroducing into commerce a substance designated as inactive on the TSCA Inventory.  Manufacturers and processors can notify EPA via a Notice of Activity Form B, found in EPA's Central Data Exchange (CDX).  Upon receiving such notification, EPA will change the designation of substances from inactive to active.

For more information, visit EPA’s TSCA Inventory Notification (Active-Inactive) Rule site.


 

By Lynn L. Bergeson and Margaret R. Graham, M.S.

On April 26, 2019, the U.S. Court of Appeals for the D.C. Circuit (D.C. Circuit) issued its order on petition for review of the U.S. Environmental Protection Agency’s (EPA) final rule on the Toxic Substances Control Act (TSCA) Inventory Notification (Active-Inactive) Requirements (82 Fed. Reg. 37520 (Aug. 11, 2017)), which denied the petition for review on all but one claim.  Petitioner Environmental Defense Fund (EDF) challenged five distinct features of the Inventory final rule:  (i) EPA’s exclusion of substantiation questions regarding reverse engineering; (ii) the final rule’s criteria for “maintaining” a confidentiality claim; (iii) EPA’s choice not to incorporate certain regulatory requirements into the final rule; (iv) EPA’s failure to implement the Act’s “unique identifier” requirements in this rulemaking; and (v) the final rule’s exemption of exported chemicals from its notification requirements. 

The D.C. Circuit’s order states that only the first claim succeeds past the standard of review required under both the Administrative Procedure Act (APA) and TSCA, however; specifically, EPA acted arbitrarily and capriciously via its “omission of any inquiry into a chemical identity’s susceptibility to reverse engineering [which] effectively excised a statutorily required criterion from the substantiation process.”  Even though EPA included several substantiation questions to address reverse engineering in the proposed rule, EPA did not include any “substantiation questions related to the requirement that a substance’s chemical identity not be susceptible to reverse engineering” and declined altogether to “‘secure answers’ substantiating a company’s ‘assertion’ that its chemical product cannot be reverse engineered” in the final rule.  The court states that this error was “fatal” and remands this issue back to EPA for EPA to “address its arbitrary elimination of substantiation questions regarding reverse engineering.”

Regarding the other four claims that it denied, the court made the following statements:

  1. “EPA acted well within its discretion in concluding that, as part of the Inventory update, any manufacturer or processor of a chemical substance can file a claim to maintain the chemical substance’s confidentiality”;
  2. “There is nothing facially troubling about the failure to copy every relevant statutory obligation into the regulation”;
  3. “Agencies need not address all regulatory obligations ‘in one fell swoop’ … nothing in [TSCA] requires the EPA to develop and implement the unique identifier system alongside its Inventory review process”; and
  4. “EPA’s decision [to exclude export-only chemicals from the final rule’s requirement that chemical companies notify EPA of chemical substances being manufactured or processed] reflected a reasonable interpretation of [TSCA].”

 

By Lynn L. Bergeson and Margaret R. Graham

On April 24, 2018, the U.S. Environmental Protection Agency (EPA) announced that it would be presenting a webinar to assist processors with reporting under the Toxic Substances Control Act (TSCA) Inventory Notification (Active-Inactive) Rule, published in the Federal Register on August 11, 2017.  This webinar, scheduled for May 23, 2018, from 1:00 p.m. to 4:00 p.m. (EDT) will “include an overview of reporting requirements for processors, a demonstration of the electronic reporting application (Central Data Exchange, or CDX), and will provide time for questions and answers.”  Registration for the webinar is not required.  The webinar will be available through the following link on May 23: http://epawebconferencing.acms.com/tsca_inventory/.  A link to access the TSCA Inventory is available here.  The upcoming deadline for voluntary submission of a Notice of Activity Form A by processors is October 5, 2018.

More information on TSCA Inventory issues is available on our blog under key phrase TSCA Inventory and in our memorandum “EPA Issues Final TSCA Framework Rules.”


 

By Lynn L. Bergeson and Carla N. Hutton

The U.S. Environmental Protection Agency’s (EPA) April 2018 Toxic Substances Control Act (TSCA) Chemical Substance Inventory is now available.  For the first time, the Inventory includes a field designating substances that are “active” in U.S. commerce based on the following:

  • Reporting from the 2012 and 2016 Chemical Data Reporting cycles;
  • Notices of Commencement received by EPA since June 21, 2006; and
  • Notice of Activity Form A’s received by EPA through the February 7, 2018, deadline, per the TSCA Inventory Notification (Active-Inactive) Rule.

EPA states that it “carefully processed and conducted a quality check of the data to ensure duplicate entries and confidential business information were removed” from the large number of notices received under the Active-Inactive Rule.  EPA also posted a list of substances reported in a Notice of Activity Form A from February 8 through March 30, 2018.  According to EPA, this list should assist processors in determining which of their substances on the Inventory have not yet been designated as “active” to date.  Based on our review, the Inventory lists approximately 38,303 total active substances, or about 44.5 percent.  The deadline for voluntary submission of a Notice of Activity Form A by processors is October 5, 2018.

If your company is having trouble reporting through EPA’s Central Data Exchange (CDX), please contact Richard E. Engler, Ph.D. or Lynn L. Bergeson to obtain a copy of our comprehensive Guidance Materials for TSCA Inventory Notification Rulemaking.  Our TSCA experts would be pleased to assist you with the reporting process!

More information on the TSCA Inventory rulemaking and TSCA Inventory issues is available on our blog under the key phrase TSCA Inventory and on our TSCA Reform News & Information web page.  More information on EPA’s Final TSCA Inventory Notification (Active-Inactive) Rule is available in our memorandum, “EPA Issues Final TSCA Framework Rules.”  Specific information on changes in the CDX system is available in our blog item, “EPA Updates eNOA Template in CDX System.”


 

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

On February 7, 2018, manufacturers that manufactured (including imported) chemicals for nonexempt commercial purposes during the ten-year time period ending on June 21, 2016, will be required to report to the U.S. Environmental Protection Agency (EPA) for the retrospective reporting period that began on August 11, 2017, per the Toxic Substances Control Act (TSCA) Inventory Notification (Active/Inactive) Requirements final rule that established a retrospective electronic notification of chemical substances on the TSCA Inventory.

If your company is having trouble reporting through EPA’s Central Data Exchange (CDX), please contact Richard E. Engler, Ph.D. or Lynn L. Bergeson to obtain a copy of our comprehensive Guidance Materials for TSCA Inventory Notification Rulemaking.  Our TSCA experts would be pleased to assist you with the reporting process!

More information on the TSCA Inventory rulemaking and TSCA Inventory issues is available on our blog under key phrase TSCA Inventory and on our TSCA Reform News & Information webpage.  Specific information on the upcoming reporting deadline and changes in the CDX system is available in our blog items EPA Offers Assistance to Manufacturers Reporting for the TSCA Inventory February 7, 2018, Deadline and EPA Updates eNOA Template in CDX System.


 

By Lynn L. Bergeson and Margaret R. Graham

On January 18, 2018, the U.S. Environmental Protection Agency (EPA) posted additional documents on its website, specifically materials from two webinars, designed to assist manufacturers reporting for the Toxic Substances Control Act (TSCA) Inventory Notification (Active-Inactive) Requirements final rule that became effective on August 11, 2017.  The rule, which established 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, requires manufacturers to report to EPA by February 7, 2018, for the retrospective reporting period that began on August 11, 2017 (180 days after the final rule was published in the Federal Register).  The webinar slides and transcripts posted have three general sections:  (1) an overview of the new reporting requirements; (2) a demonstration of the electronic reporting application in CDX; and (3) a question and answer session, where technical questions related to the reporting requirements and the electronic reporting application were addressed.  These materials are:

An additional helpful development for manufacturers is the recent launch of the American Chemistry Council’s (ACC) TSCA Inventory Reset CDX Receipt Database.  The database allows manufacturers, importers, and processers under TSCA to upload and share Central Data Exchange (CDX) receipts.  Further, it is being reported that EPA will also be providing and updating a list of frequently asked questions prior to the February 7 deadline. 

Following this retrospective reporting for manufacturers, EPA will include the active designations, determined by the notices received, on a draft of the Inventory.  EPA will publish the draft Inventory with the active designations “as soon as is practicable” following the close of the 180-day submission period.  The draft Inventory will not have the legal effect of actually designating any chemical substance as inactive, however, and EPA does not construe it as the list with “designations of active substances and inactive substances” from which forward-looking reporting commences.  EPA states that it concludes that new TSCA is referring to the completed product of the initial cycle of sorting between active and inactive substances, not the preliminary product of the initial cycle of such sorting.

More information on the TSCA Inventory rulemaking and TSCA Inventory issues is available on our blog under key phrase TSCA Inventory and on our TSCA Reform News & Information webpage.


 

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 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.  


 
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