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 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.


 

By Charles M. Auer and Richard E. Engler, Ph.D.

The U.S. Environmental Protection Agency (EPA) has updated its eNOA upload template that was initially released in 2017 to assist filers with the Central Data Exchange (CDX) system.  The eNOA, or electronic Notice of Activity (NOA) Form, is used for retrospective reporting under the amended Toxic Substances Control Act’s (TSCA) Inventory notification requirements.  The eNOA template, available for download from within the eNOA system on CDX, assists users to upload many substance identities in a batch.  The template file is a comma separated value (CSV) file, CSV-NAA.csv, that is readable by most spreadsheet and database programs.  The change means that if submitters attempt to use the old template, the CSV file will not upload properly and will generate errors in CDX. 

The template was updated by adding a new field name.  The new field name that will be added to the CSV file is “Isjoint,” and the field explanation is “NOA is joint with another submitter;” which permits filers to upload and start multiple joint submissions in a batch.  The field names required, along with their field explanations, are: 

  • Isjoint: NOA is joint with another submitter.
  • CASRN:  CASRN with our without dashes; after upload, dashes will be present.  Must be “TRUE” or “FALSE”;
  • Accession Number:  Accession number for substances listed on the confidential portion of the Inventory;      
  • Chemical Cbi:  Submitter seeking to maintain CBI claim for substance identity.  Must be “TRUE” or “FALSE”;
  • Submitter Cbi: Submitter claiming CBI for submitter identity.  Must be “TRUE” or “FALSE”;
  • Company Details Cbi: Submitter claiming CBI for submitting company details.  Must be “TRUE” or “FALSE”;
  • Technical [Contact] Cbi:  Submitter claiming CBI for technical contact identity.  NB: “Contanct” is misspelled in the template.  Must be “TRUE” or “FALSE”;
  • Substantiation CBI:  Submitter claiming CBI for substantiation statement(s).  Must be “TRUE” or “FALSE”; and
  • ShowCbiQuestions:  Set to TRUE to substantiate CBI claims.  This is required for submitter, company, and technical contact claims.  Must be “TRUE” or “FALSE.” 

 

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.  


 
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