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 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, EPA 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, Charles M. Auer, Richard E. Engler, Ph.D., and Carla N. Hutton

On April 23, 2019, the U.S. Environmental Protection Agency (EPA) issued a proposed rule regarding its plan to review certain confidential business information (CBI) claims to protect the specific chemical identities of substances on the confidential portion of the Toxic Substances Control Act (TSCA) Inventory.  84 Fed. Reg. 16826.  The CBI claims that would be reviewed under this plan are those that were asserted on Notice of Activity (NOA) Form A’s filed in accordance with the requirements in the Active-Inactive rule.  Comments are due June 24, 2019See the full memorandum for more information on the proposed rule. 


 

By Lynn L. Bergeson, Carla N. Hutton, and Margaret R. Graham

On February 19, 2019, the U.S. Environmental Protection Agency (EPA) announced that it was releasing an update to the Toxic Substances Control Act (TSCA) Inventory listing the chemicals that are actively being manufactured, processed and imported in the United States, which is required under amended TSCA.  Some of the highlights from EPA’s announcement are:

  • A key result of the update is that less than half of the total number of chemicals on the current TSCA Inventory (47 percent or 40,655 of the 86,228 chemicals) are currently in commerce; EPA states that this information will help it focus risk evaluation efforts on chemicals that are still on the market.
  • As recently as 2018, the TSCA Inventory showed over 86,000 chemicals available for commercial production and use in the U.S.  Until this update, EPA states that it was not known which of these chemicals on the TSCA Inventory were actually in commerce.
  • More than 80 percent (32,898) of the chemicals in commerce have identities that are not Confidential Business Information (CBI), increasing public access to additional information about them.  
  • For the less than 20 percent of the chemicals in commerce that have confidential identities, EPA states that it is developing a rule outlining how it will review and substantiate all CBI claims seeking to protect the specific chemical identities of substances on the confidential portion of the TSCA Inventory. 
  • From August 11, 2017, through October 5, 2018, chemical manufacturers and processors provided information on which chemicals were manufactured, imported or processed in the U.S. over the past ten years, the period ending June 21, 2016.  EPA received more than 90,000 responses, a significant reporting effort by manufacturers, importers and processors.

Look for our memorandum on this important development tomorrow; it will be posted to our Regulatory Developments webpage.  

On March 13, 2019, EPA will host a webinar to assist manufacturers (including importers) and processors with future reporting requirements.  Under the final TSCA Inventory notification (active-inactive) rule, a substance is not designated as an “inactive substance” until 90 days after EPA publishes the initial version of the Inventory with all listings identified as active or inactive.  EPA states that manufacturers and processors should be aware that if there is a substance that is listed as “inactive” that is currently being manufactured or processed, they have 90 days to file a Notice of Activity (NOA) Form B so that they can continue their current activity.  Manufacturers and processors that intend to manufacture or process an “inactive” substance in the future must submit an NOA Form B before they start their activity.

The webinar is scheduled for 1:00 p.m. - 4:00 p.m. (EDT) on Wednesday, March 13, 2019.  The webinar will include an overview of filing a NOA Form B, a demonstration of the electronic reporting application, and time for questions and answers.  Registration for the webinar is not required.

More information about the TSCA Inventory update and the webinar is available on EPA’s TSCA Chemical Substance Inventory webpage.


 

By Lynn L. Bergeson and Margaret R. Graham

On October 5, 2018, the U.S. Environmental Protection Agency (EPA) issued the general approaches that the Office of Pollution Prevention and Toxics (OPPT) may use to identify potential candidate chemicals for prioritization under TSCA.  83 Fed. Reg. 50366.  EPA notes that it will seek public comment on the approach document and on which chemicals should be identified as potential candidates for the initial 20 high-priority and 20 low-priority chemicals that must be identified pursuant to TSCA Section 6(b)(2)(B).  Comments are due by November 15, 2018

The document, A Working Approach for Identifying Potential Candidate Chemicals for Prioritization, lays out EPA’s thinking regarding a near-term approach for identifying potential chemicals for prioritization, the initial step in evaluating the safety of existing chemicals under TSCA.  The approach document also includes a longer-term risk-based strategy for managing the larger TSCA chemical landscape that, according to the portion of the TSCA Chemical Substance Inventory (Inventory) that includes the substances designated as active (TSCA Active Inventory), is expected to include over 38,000 chemicals reported as “active” under the TSCA Inventory Notification (Active-Inactive) Requirements final rule.  More information is available in our memorandum “EPA Releases Working Approach for Identifying Potential Candidate Chemicals for Prioritization under 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 Margaret R. Graham

On March 6, 2018, in the U.S. Court of Appeals for the D.C. Circuit, the Environmental Defense Fund (EDF) filed its Principal Brief in the litigation case that petitions for review the U.S. Environmental Protection Agency’s (EPA) Toxic Substances Control Act (TSCA) Inventory Notification (Active-Inactive) Requirements final rule (EDF v. EPA, No. 1701 (D.C. Cir.)).

EDF’s brief includes, among other required statements, a statement of the issues, a statement of the case, a summary of their argument, and their argument.  EDF’s arguments are as follows:

  1. The Inventory Rule withholds information on chemical substances manufactured or processed in the U.S. from the public; this information is required to be disclosed under amended TSCA; EDF has been harmed by EPA’s failure to disclose this information and to disclose unique identifiers for confidential chemicals; and the court can redress this harm.  
  2. The final rule illegally allows manufacturers and processors to assert certain new claims for nondisclosure of specific chemical identities based on other persons having asserted earlier claims, which is contrary to TSCA’s plain text and the relevant precedent governing confidentiality claims; and EPA’s rationale for its interpretation is arbitrary and capricious.
  3. The final rule violates both the substantive and procedural requirements of TSCA Section 14, Confidential Information, specifically that:  EPA refused to accept that TSCA Section 8, Reporting and Retention of Information, repeatedly incorporates Section 14 requirements for confidentiality claims; the final rule fails to implement one of the substantive requirements for confidentiality claims under Section 14; and the final rule fails to implement one of the substantive requirements for confidentiality claims under Section 14.
  4. The final rule fails to implement the unique identifier and other public information requirements in TSCA Section 8(b)(7)(B).
  5. The final rule exempts chemicals manufactured and processed solely for export from the reporting requirements, even though such chemicals are specifically not exempted from TSCA Section 8.
  6. Finally, EDF requests the court to set aside the rule in part, stating that vacatur, along with remand, is the appropriate remedy for EPA’s violations of the Administrative Procedure Act (APA).  EDF does not seek a complete vacatur, however, stating that “a complete vacatur would postpone the release of some of the very information that EDF seeks, since it would allow EPA to postpone publishing the Inventory based on the information it has already collected.  In addition, it would impose costs on the regulated community beyond those necessary to remedy EDF’s harms [and] those manufacturers and processors who have already filed notices without claims of confidentiality should not need to refile the notices.”  The portions of the final rule that EDF requests the court to vacate are as follows:  the exclusion for export-only manufacturers (40 C.F.R. Section 710.27(a)(4)); Confidentiality Claims (40 C.F.R. Section 710.37); and certain portions of the preamble. EDF states specific instructions on how it would like the court to order EPA to promulgate the regulation on remand that include revisions to regulations on confidentiality claims, public information requirements, and notifications of activities during the lookback period.

EDF has done its usual thorough job and the brief is definitely a must read for TSCA stakeholders.  More information on this proceeding and the other challenges to the TSCA framework final rules is available on our blog under key words framework rules.


 

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.


 
 1 2 >