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
 

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.


 

Chemical manufacturers and processors have just over four months to submit Chemical Data Reporting (CDR) data by the November 30, 2020, close of the reporting period. To assist companies in that process, Bergeson & Campbell, P.C. (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 reporting 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 TSCA regulatory actions in 2016;
     
  • Whether the chemical is exempt; and
     
  • What the reporting thresholds are based on the updated data released by the U.S. Environmental Protection Agency (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 May 29, 2020, the U.S. Environmental Protection Agency (EPA) released updated data collected during the 2016 Chemical Data Reporting (CDR) period.  EPA notes that the updated 2016 CDR data now include information that was previously classified as confidential business information (CBI), such as aggregate production volumes and site-specific production volumes.  EPA published an initial release of the 2016 CDR data in May 2017.  The Frank R. Lautenberg Chemical Safety for the 21st Century Act (Lautenberg Act) amendments to the Toxic Substances Control Act (TSCA) were signed into law during the 2016 CDR submission period and changed CDR CBI reporting requirements.  EPA states that as a result, it conducted “a thorough substantiation and verification process with companies that submitted 2016 CDR data.”  According to EPA, this process allowed it to determine which claims met the new legal standard and ensure that valid CBI claims remained protected.

Background

On March 17, 2020, EPA announced the availability of a final rule amending the CDR rule.  EPA states that some of the key revisions include simplifying reporting, including allowing manufacturers to use certain processing and use data codes already in use by many chemical manufacturers as part of international codes developed through the Organization for Economic Cooperation and Development (OECD); updating requirements for asserting confidentiality claims to align with the requirements in amended TSCA; and adding reporting exemptions for specific types of byproducts manufactured in certain equipment.  Additionally, EPA is extending the reporting period for CDR data submitters from September 30, 2020, to November 30, 2020, to provide additional time for the regulated community to familiarize themselves with the amendments and to allow time for reporters to familiarize themselves with an updated public version of the reporting tool.  More information is available in our March 19, 2020, memorandum, “EPA Releases Final Amendments to CDR Rule, Extends Reporting Period.”

Our May 13, 2020, blog item, “New Reporting Procedure for Co-Manufacturers under TSCA CDR Rule May Catch Certain Manufacturers Off Guard,” notes that EPA has changed the way that toll manufacturing must be reported.  In this cycle, EPA will not accept reporting from only the contracting manufacturer in situations where a company contracts with another company (i.e., a toll manufacturer) for the production of chemicals.  In 2020, EPA has stated in multiple fora that for the 2020 reporting period, EPA will only accept manufacturing details from the actual producers, even if manufacturing was contracted by another company.  This change may come as a surprise, especially to producing companies that heretofore may not have reported under the CDR rule and instead relied on the contracting company to do so.

Tags: CBI, CDR

 

By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) will host a webinar on May 19, 2020, from 1:00 to 3:00 p.m. (EDT) to provide an overview of the 2020 Chemical Data Reporting (CDR) requirements.  The 2020 CDR submission period is from June 1, 2020, to November 30, 2020.  The webinar will include information about the revised reporting requirements, including:

  • New requirements for making confidential business information (CBI) claims;
  • Reporting refinements related to byproducts, including exemptions;
  • Phasing in certain processing and use data codes; and
  • Process improvements for reporting co-manufacturing.

The webinar will also introduce the updated e-CDRweb reporting tool.  EPA notes that the presentation will be similar to the webinars EPA hosted on March 31 and April 9, 2020.
 
EPA states that although registration is not required, it is preferred.  Details on how to access the webinar and slides will be sent to participants after registering via Eventbrite.com.  Participants should follow along with the webinar slides and use the following call-in number to access the audio:  (866) 609-6049; Conference ID:  2499985.  EPA will provide webinar materials, including transcripts and recordings, on its CDR website following the webinar.

Tags: CDR, Webinar, CBI

 
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