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 (EPA) announced on October 15, 2021, that it is updating the confidential status of 377 chemical identities and will include these chemical identities on the next update of the Toxic Substances Control Act (TSCA) Inventory, planned for winter 2022. The TSCA Inventory is a list of all existing chemical substances manufactured, processed, or imported in the United States. According to EPA, the Inventory contains 86,607 chemicals, of which 41,953 are active in U.S commerce.

As reported in our April 30, 2021, blog item, in April 2021, EPA announced its review of 390 specific chemical identities that were expected to lose their confidential status on the TSCA Inventory. Of the 390 chemicals under review, EPA states that it found that 13 accession numbers corresponded to substances that are already on the public portion of the Inventory or to substances reported using an invalid accession number (which was later corrected and/or the confidentiality claim was withdrawn). The remaining 377 chemical identities were reported as non-confidential by one or more manufacturers during the 2012, 2016, and/or 2020 Chemical Data Reporting (CDR) periods -- “meaning that at least one manufacturer did not request that each of these chemical identities be kept confidential, effectively saying it is not a secret that the chemical is in U.S. commerce. Therefore, these substances are no longer eligible for continued confidential Inventory status.”


 

By Lynn L. Bergeson and Carla N. Hutton
 
On August 23, 2021, the U.S. Environmental Protection Agency (EPA) announced the availability of and solicited public comment on guidance on two petition processes applicable to the Toxic Substances Control Act (TSCA) Chemical Data Reporting (CDR) regulations. 86 Fed. Reg. 47102. The guidance covers petitions for full exemption of byproduct substances that are recycled or otherwise used within site-limited, physically enclosed systems and petitions for partial exemption of chemicals for which the CDR processing and use information has been determined to be of “low current interest” by EPA. EPA states that the guidance “is designed to elucidate the process and requirements of CDR-specific petitions and is consistent with both existing regulations and guidance.” The CDR regulations require manufacturers (including importers) of certain chemical substances included on the TSCA Chemical Substance Inventory (TSCA Inventory) to report data on the manufacturing, processing, and use of the chemical substances. According to EPA, the guidance identifies and clarifies examples of the types of information submitters can provide to EPA in support of petitions for full or partial exemption from CDR rule requirements. EPA expects the guidance to make the requirements and process of submitting a CDR-specific petition “more comprehensible,” enabling petitioners to determine if a petition is appropriate and to provide better a petition containing the information needed for EPA to reach a determination. Comments on the guidance are due December 21, 2021.


 

By Lynn L. Bergeson and Carla N. Hutton

The U.S. Environmental Protection Agency (EPA) met with the Environmental Defense Fund (EDF) on August 5, 2021, to clarify concepts from the July 27, 2021, tiered data reporting (TDR) webinar. EPA’s meeting summary states that EDF representatives requested clarification on the following issues discussed during the webinar:

  • Whether EPA intends to scale back the Chemical Data Reporting (CDR) requirements with respect to the amount of information collected per chemical or to the number of chemicals reported.
    • EPA responded that the changes to CDR discussed in the webinar presentation would reduce the data collected per chemical and would not impact which chemicals were required to be reported under CDR.
  • Whether the data expected to be used to inform the identification of potential candidate chemicals for prioritization was limited to CDR.
    • EPA responded that the webinar presentation was not intended to identify all sources of information that would be used for the various steps of the overall existing chemicals process, including informing the identification of the pool of potential candidate chemicals for the prioritization process. Rather, the intent was to identify the data that would be available from either CDR or TDR for use for each step in the process.
  • Reasoning behind EPA’s decisions regarding timing of the collection tiers and selected data elements.
    • EPA responded that the specifics of what data elements would be included in which collection tiers was under development and that the Agency is interested in comments from EDF or other stakeholders to help inform the TDR proposal.
  • Whether EPA had any more details about the post-risk management stage, which was included in the webinar presentation as “TBD.”
    • EPA responded that there were no additional details at this time.

According to the meeting summary, EDF provided additional comments during the meeting, including concern about scaling back CDR; belief that data should be collected earlier in the existing chemicals process to be more useful and enable EPA to make better use of TSCA Section 4; and a request to make the reported data publicly available in a timely manner to inform public comment. EDF “also reiterated their concern with the length of the comment period following the webinar.” The meeting summary states that EPA will accept supplemental comments after August 16, 2021, that are e-mailed to Susan Sharkey (.(JavaScript must be enabled to view this email address)), but that such comments should be provided as soon as possible. EPA noted that interested parties could comment during interagency review and following the publication of the proposal.

More information on EPA’s July 27, 2021, webinar is available in our July 29, 2021, memorandum. As reported in our August 6, 2021, blog item, EPA posted a memorandum in Docket ID EPA-HQ-OPPT-2021-0436 stating that it will not extend the August 16, 2021, comment period stemming from the July 27, 2021, public webinar.


 

By Lynn L. Bergeson and Carla N. Hutton
 

On July 27, 2021, the U.S. Environmental Protection Agency’s (EPA) Office of Chemical Safety and Pollution Prevention (OCSPP) will hold a public meeting to engage with interested stakeholders on the development of a proposed rule for implementing a tiered data collection strategy to help inform EPA’s prioritization, risk evaluation, and risk management activities for chemical substances or mixtures under the Toxic Substances Control Act (TSCA). According to EPA, it currently primarily collects exposure-related data through the TSCA Chemical Data Reporting (CDR) process. EPA is interested in ensuring that data collection strategies provide information to meet better its basic chemical data needs, such as information related to exposure, health, and ecotoxicity. To this end, EPA states that it is exploring a data reporting rule that is tiered to specific stages of the TSCA existing chemicals program: identifying a pool of substances as potential candidates for prioritization; selecting candidate chemicals for and completing the prioritization process; and assessing high-priority substances through a robust risk evaluation, which may be followed by risk management actions (depending on the outcome of the risk evaluation). According to EPA, feedback from the public meeting and comments received will help inform its development of a proposed rule. The meeting will be held virtually via WebEx on July 27, 2021, from 1:00 to 3:00 p.m. (EDT). Those who would like to make a comment during the meeting must register by 6:00 p.m. EDT on July 22, 2021. Those who would like to participate in listen-only mode must register by 6:00 p.m. EDT on July 26, 2021. Written comments are due August 15, 2021.


 

By Lynn L. Bergeson and Carla N. Hutton

The Center for Environmental Health (CEH) announced on June 29, 2021, that it filed suit against three companies in the U.S. District Court for the District of Columbia for alleged violations of the Chemical Data Reporting (CDR) rule. According to CEH, an investigation found that four companies imported 65 chemicals that are subject to reporting under the CDR rule. CEH states that the chemicals “include several recognized carcinogens, including benzene, butadiene, trichloroethylene, isoprene, di(2-ethylhexyl)phthalate, di-isononyl phthalate, carbon black and arsenic.” In February 2021, CEH notified the importers of the apparent violations in accordance with Section 20(b) of the Toxic Substances Control Act (TSCA). One of the four companies, Tribute Energy, “approached CEH and entered into an agreement to audit its operations and come into compliance. CEH is not taking legal action against Tribute in recognition of its good faith and commitment to following the law.” CEH filed suit against the other three companies under TSCA Section 20(a). The three companies are 3N International, Harwick Standard Distribution Corp., and Braskem Inc. CEH notes that the U.S. Environmental Protection Agency (EPA) has designated some of the chemicals as high-priority substances under TSCA and is conducting risk evaluations to determine whether they present an unreasonable risk to human health or the environment. CEH states that “CDR reporting is critical in determining these risks because, according to EPA, the ‘exposure information [reported] is an essential part of developing risk evaluations and . . . collecting this exposure information is critical to [EPA’s] mission of characterizing exposure [and] identifying potential risks.’” CEH asks that the court order the companies to report their imports in compliance with the CDR rule and restrain the companies from any other ongoing violations of CDR reporting requirements.


 

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
 
On March 2, 2021, the U.S. Environmental Protection Agency (EPA) announced that it reached a settlement agreement with Brenntag Pacific, Inc. for violations of the Toxic Substances Control Act (TSCA).  According to EPA, Brenntag Pacific, Inc. has corrected the violations and will pay a $128,265 fine.  EPA states that it discovered the violations following inspections at Brenntag Pacific, Inc. facilities in Fairbanks, Alaska, and in Santa Fe Springs, California.  EPA inspectors “found the company failed to submit accurate and timely reports and notification associated with the import and export of nine chemicals.”  According to EPA, between 2012 and 2015, Brenntag Pacific, Inc. failed to report properly the import production volumes and uses of five chemicals as required by the 2016 Chemical Data Reporting (CDR) Rule.  In addition, the company failed to produce first-time export notices for four chemicals between 2016 and 2017.  EPA notes that under TSCA, chemical importers and manufacturers are required to submit CDR information to EPA every four years.  EPA uses these data to track the chemicals being imported into the United States and to assess the potential human health and environmental effects of these chemicals.  In addition, EPA makes the non-confidential business information it receives available to the public.


 

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.


 
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