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

As reported in our April 30, 2021, blog item, on April 29, 2021, the U.S. Environmental Protection Agency (EPA) announced the release of a list of 390 chemicals that it states are “expected to lose their confidential status and move to the public portion of the Toxic Substances Control Act (TSCA) Inventory, furthering the agency’s commitment to data transparency.” EPA announced on May 14, 2021, that it is extending the notification deadline to June 30, 2021. According to EPA, the American Chemistry Council and BASF requested additional time to review the list of 390 chemicals. EPA states that concerns were expressed over the potential that some of the chemicals overlap with those reported under the Active-Inactive rule and the perception that EPA relied only on 2020 Chemical Data Reporting (CDR) rule submissions to identify these chemicals.

According to EPA, in regard to the industry concerns that it relied solely on 2020 CDR submissions, it plans to declassify the specific identities of these chemicals because one or more manufacturers reported the chemicals as non-confidential during the 2012, 2016, and/or 2020 CDR reporting periods -- “meaning that at least one manufacturer did not request that each of the chemical identities be kept confidential, effectively saying it is not a secret that the chemical is in U.S. commerce.” EPA states that additionally, it did an “extensive review” of each individual instance in which confidential status was not requested for these chemical identities to confirm the accuracy of the list.

EPA acknowledges that some of the chemicals may also have been reported or subject to reporting under the Active-Inactive rule, which required companies to identify chemicals manufactured, imported, or processed in the United States during the ten-year time period ending on June 21, 2016. Although EPA is aware that there may have been submitter confusion and questions regarding confidentiality claims during the initial reporting period, it states that for each of the 390 chemicals, “there is also one or more independent CDR-based (and EPA-validated) reasons to consider the chemical identities to be no longer eligible for inclusion on the confidential portion of the Inventory.” EPA intends to update the TSCA Inventory listings for these chemicals to list the specific chemical identities on the public portion of the Inventory during summer 2021.

EPA states that stakeholders with interest, questions, or concerns about this change in confidential status may contact the EPA staff listed on its webpage no later than June 30, 2021. Stakeholders should review the list of substances and ensure that none of those substances is of critical importance to maintain confidential status.


 

By Lynn L. Bergeson and Carla N. Hutton

On April 29, 2021, the U.S. Environmental Protection Agency (EPA) announced the release of a list of 390 chemicals that it states are “expected to lose their confidential status and move to the public portion of the Toxic Substances Control Act (TSCA) Inventory, furthering the agency’s commitment to data transparency.”  According to EPA, the specific identities of these chemicals were reported as non-confidential during Chemical Data Reporting (CDR) cycles from the 2012, 2016, and/or 2020 reporting periods.  In accordance with the CDR rule and with TSCA Sections 8 and 14, EPA intends to update the TSCA Inventory listings for these chemicals to list the specific chemical identities on the public portion of the Inventory.  Stakeholders should check the list of substances and ensure that none of those substances is of critical importance to maintain confidential status.  Stakeholders with interest, questions, or concerns about this change in confidential status may contact the listed EPA staff no later than May 14, 2021.  EPA expects to include the specific chemical identities of these 390 chemicals in the next routine publication of the public TSCA Inventory, anticipated in late summer 2021.


 

By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) announced on March 15, 2021, a settlement requiring Western Reserve Chemical Corp. (WRCC) in Stow, Ohio, to pay a $357,000 civil penalty for violations of chemical data reporting regulations under the Toxic Substances Control Act (TSCA).  EPA claims that from 2012 to 2015, WRCC failed to submit data reports for 18 chemical substances as required by TSCA.  According to EPA, WRCC imports various chemicals for businesses that formulate rubber, plastics, adhesives, sealants, and coatings.  EPA states that the alleged violations “presented a potential harm to the Agency’s ability to maintain accurate and updated information regarding commercially-produced chemicals.”  EPA’s consent agreement and final order with WRCC resolves the alleged violations and requires the payment of a $357,000 civil penalty in installments within 18 months.
 
Information about chemical reporting is available on the TSCA Chemical Data Reporting web page.  EPA notes that the chemical data reports for 2016 to 2019 were due from industry manufacturers by January 29, 2021.  The Substance Registry Services web page offers a search function to find out if a specific chemical is on the TSCA Inventory.


 

By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) announced on February 3, 2021, the latest update to the Toxic Substances Control Act (TSCA) Inventory, “a list of all existing chemical substances manufactured, processed, or imported” in the United States.  EPA states that this biannual update to the public TSCA Inventory is part of its regular posting of non-confidential TSCA Inventory data.  EPA plans to release the next regular update of the Inventory in summer 2021.  According to EPA, the Inventory contains 86,557 chemicals of which 41,864 are active in U.S commerce.  EPA notes that other updates to the TSCA Inventory include new chemical substance additions, commercial activity data, and regulatory flags, such as polymer exemptions, TSCA Section 4 test orders, and TSCA Section 5 significant new use rules (SNUR).


 

By Lynn L. Bergeson and Carla N. Hutton
 

The U.S. Environmental Protection Agency (EPA) announced on January 5, 2021, that it is reopening the reporting period under the Toxic Substances Control Act (TSCA) Inventory notification active-inactive rule where companies identified chemicals that were manufactured, imported, or processed in the United States during the ten-year time period ending on June 21, 2016.  As reported in our June 26, 2017, memorandum, “EPA Issues Final TSCA Framework Rules,” the final TSCA Inventory notification (active-inactive) rule 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, with provision to also allow notification by processors.  From August 11, 2017, through October 5, 2018, chemical manufacturers and processors provided information on which chemicals were manufactured, imported, or processed in the United States over the past ten years.  The reporting period included an opportunity for submitters to assert claims to retain specific chemical identities as confidential business information (CBI).  In May 2020, EPA posted an interim list of chemicals expected to lose their CBI status and move to the public portion of the TSCA Inventory.  In its January 5, 2021, announcement, EPA states that it since become aware of “submitter confusion and issues regarding CBI claims” during the initial reporting period.  EPA is allowing companies to submit, amend, or withdraw filings under the TSCA Inventory notification (active-inactive) rule to maintain existing CBI claims for specific chemical identity.  The reporting period will reopen 30 days after publication in the Federal Register and run for 60 days after that date.


 

By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) will soon announce that the Chemical Data Reporting (CDR) submission period has been extended from November 30, 2020, to January 29, 2021.  A Federal Register notice has been signed, and EPA expects to post a pre-publication version of the notice on its website.  To assist chemical manufacturers and processors with submitting CDR data, Bergeson & Campbell, P.C.’s (B&C®) affiliate The Acta Group (Acta®) developed CDR Cross-Check™, an ingenious and cost-efficient tool to identify whether a company’s chemicals are subject to CDR and, if so, at what reporting threshold.
 
CDR Cross-Check will identify:

  • Whether the chemical is listed as active or inactive;
  • Whether the chemical was subject to specific Toxic Substances Control Act (TSCA) regulatory actions in 2016;
  • Whether the chemical is exempt; and
  • What the reporting thresholds are based on the updated data released by EPA on May 29, 2020.

Visit the CDR Cross-Check page on the Acta website for a sample report and information on how to use CDR Cross-Check.


 

By Lynn L. Bergeson and Carla N. Hutton
 
On October 16, 2020, the U.S. Environmental Protection Agency (EPA) reminded companies that if they filed a retrospective activity notice (Notice of Activity (NOA) Form A) under the Toxic Substances Control Act (TSCA) Inventory Notification (Active-Inactive) Rule and claimed the specific chemical identity as confidential business information (CBI), they have until November 1, 2020, to submit or amend their CBI substantiations.  Companies that amend, update, or file new CBI substantiations must do so electronically via EPA’s Central Data Exchange.

Background

On March 6, 2020, EPA promulgated a final rule on procedures for review of CBI claims made under TSCA.  The final rule includes the requirements for regulated entities to substantiate certain CBI claims made under TSCA to protect the specific chemical identities of chemical substances on the confidential portion of the TSCA Inventory, and EPA’s plan for reviewing certain CBI claims for specific chemical identities.  The substantiation requirements describe the applicable procedures and provide instructions for regulated entities.  EPA sets out the review criteria and related procedures that it will use to complete the reviews within the five-year timeframe set in TSCA.  More information is available in our February 28, 2020, memorandum, “EPA Releases Final Rule on Procedures for Review of CBI Claims for the Identity of Chemicals on the TSCA Inventory.”

Tags: CBI, NOA, Inventory

 

By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) announced on June 1, 2020, the availability of the latest Toxic Substances Control Act (TSCA) Inventory.  EPA notes that this biannual update to the public TSCA Inventory is part of its regular posting of non-confidential TSCA Inventory data.  EPA plans the next regular update of the Inventory for early 2021.  According to EPA, the Inventory contains 86,405 chemicals, of which 41,587 are active in U.S commerce.  Other updates to the TSCA Inventory include updates to commercial activity data and updated regulatory flags, such as consent orders and significant new use rules (SNUR).

Tags: Inventory,

 

The Acta Group (Acta®) announced today the launch of CDR Cross-Check™, an ingenious yet simple tool developed and offered by Acta to assist companies in preparing for the 2020 Chemical Data Reporting (CDR) required by the U.S. Environmental Protection Agency (EPA). CDR Cross-Check utilizes the most recent CDR listing information publicly available provided by EPA (currently, 2016 lists) to identify whether all or some of a company’s inventory of chemical substances are subject to CDR under the Toxic Substances Control Act (TSCA) and, if so, at what reporting threshold. CDR Cross-Check will make CDR reporting easier.

CDR Cross-Check will identify whether chemicals are listed on the TSCA Inventory and, if so,

  • whether they are listed as active or inactive;
     
  • whether they were subject to specific TSCA regulatory actions in 2016;
     
  • whether they are exempt; and
     
  • what the 2020 reporting thresholds would be based on the 2016 data.

Sample CDR Cross-Check™ Report:

(Click image to enlarge.)

A CDR Cross-Check report prepared at this time will be extremely useful as a preliminary check in preparation for the 2020 CDR reporting. It will confirm regulatory statuses from the 2016 reporting cycle, so for those chemicals, users will know what the reporting threshold will be for 2020 and can determine now whether reporting is needed. It will also give users time to address potential issues well before the 2020 reports are due.

To access CDR Cross-Check, a customer will upload the list of chemicals to be evaluated by the CDR Cross-Check tool and pay the appropriate fee based on the number of chemicals to be evaluated. Fees are $3.00 (USD) per chemical for the first 750 chemicals plus $2.00 (USD) per chemical for additional chemicals over 750. The minimum fee is $400 (USD).

Acta anticipates that additional chemicals will be added to the regulatory lists in June 2020 that may result in lower reporting thresholds. The CDR Cross-Check will be updated at that time to include the new lists. Customers that have already used the CDR Cross-Check prior to the 2020 updates will receive a 50% discount for an updated list.

Visit the CDR Cross-Check website, https://cdr-cross-check.actagroup.com/, for more information and to order a CDR Cross-Check report.

More information on recent CDR developments is available in Acta’s March 19, 2020, memorandum “EPA Releases Final Amendments to CDR Rule, Extends Reporting Period.”

The Acta Group is a global scientific and regulatory consulting firm that assists companies with strategic commercialization planning and complex product registration and compliance matters in North America, South America, Europe, the Middle East, and Asia. Acta is the consulting affiliate of Washington, D.C., law firm Bergeson & Campbell, P.C.


 

By Lynn L. Bergeson and Carla N. Hutton
 
On March 30, 2020, the U.S. Environmental Protection Agency (EPA) published the 2020 Mercury Inventory Report on the supply, use, and trade of mercury in the United States.  The report presents aggregated data submitted on imported mercury, mercury manufactured in the United States, imported mercury-added products, mercury-added products made in the United States, and mercury used in manufacturing processes.  The inventory report also provides a broad view of U.S. mercury stored, sold, and exported, as well as industry sectors and countries involved in the supply, use, and trade of mercury.  According to EPA, highlights of the report include:

  • No indication of imports or exports of elemental mercury into or out of the United States during the reporting year;
     
  • Continuation of the overall steady decline in the use of mercury in products, indicative of the growing presence and use of effective alternatives;
     
  • A decrease in the amount of mercury used in switches and relays manufactured in or imported into the United States -- data submitted also fill a significant information gap;
     
  • Only a single mercury-based manufacturing process identified as ongoing in the United States; and
     
  • Information relevant for U.S. implementation of the Minamata Convention on Mercury.

EPA notes that the 2020 Mercury Inventory Report is the first inventory published under the 2018 rule requiring reporting from persons who manufacture (including import) mercury or mercury-added products, or otherwise intentionally use mercury in a manufacturing process.  According to EPA, this means that the data presented in the 2020 report come directly from the companies that are using, manufacturing, or importing mercury, providing EPA and the public with more reliable and complete information on the supply, use, and trade of mercury in the United States.  EPA states that the initial 2017 inventory, on the other hand, was limited to publicly available data.  In addition, the 2020 report incorporates data from contextual reporting requirements, resulting “in more extensive information on the industries that purchase mercury-added products, countries of origin and destination for imports and exports, and the specific ways that mercury is used in certain manufacturing processes.”  More information will be available in a forthcoming memorandum that will be posted on our website.


 
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