Bergeson & Campbell, P.C. (B&C®) is a Washington, D.C., law firm providing biobased and renewable chemical product stakeholders unparalleled experience, judgment, and excellence in bringing innovative products to market.

By Lynn L. Bergeson

B&C, the Environmental Law Institute (ELI), and the George Washington University Milken Institute School of Public Health are pleased to present "TSCA Reform -- Four Years Later," on June 24, 2020. This complimentary virtual conference marks the fourth Toxic Substances Control Act (TSCA) Annual Conference, reflecting on the accomplishments and challenges since the implementation of the 2016 Lautenberg Amendments and where TSCA stands today.

Speakers include:

Panelists will dive into a host of topics, including the current impacts of TSCA on science policies, challenges faced by industry, and regulatory policies, especially those concerning ensuring compliance and enforcement. Mark your calendar to join ELI, B&C, the George Washington University Milken Institute School of Public Health, leading experts, and distinguished keynote speakers in a day-long exploration of the issues and regulations surrounding TSCA.


 

By Lynn L. Bergeson

From June 15 to 19, 2020, the American Chemical Society (ACS) will be hosting their annual Green Chemistry and Engineering (GC&E) Conference virtually. Richard E. Engler, Ph.D., Director of Chemistry at Bergeson & Campbell, P.C. (B&C®) will be proudly presenting a poster titled: “TSCA Tutor -- The Importance of Regulatory Awareness and Applications.” The poster presentation will highlight B&C’s complete suite of TSCA TutorTM regulatory training courses online and on-demand. This year’s conference registration is free, so check out B&C’s poster and contact us if you are interested in learning more about TSCA TutorTM.

Professionals seeking expert, efficient, essential training can preview and enroll in on-demand classes to complete at their own pace and timing. In addition to the newly released online e-learning courses, B&C’s TSCA TutorTM training platform offers live in-person training at a company’s site and customized live webinar training, so that companies can mix and match training modules and training approaches to provide the most suitable combination for their work needs.

TSCA awareness is a critically important element in the 21st century work environment for any business that involves industrial chemicals. The new normal requires awareness of TSCA’s application to a company’s operations to ensure consistent compliance with TSCA regulations and, importantly, to understand and anticipate how EPA’s ongoing implementation of new TSCA will affect a company’s industrial chemical selection and use processes.

TSCA TutorTM online training courses include:

  • Video lessons.
     
  • Detailed handout materials, including copies of all presentations and relevant course materials from EPA and other sources.
     
  • Customizable, yet detailed and ready-to-use Standard Operating Procedures (SOP) for the regulatory topic covered in the session.

The courses were developed and are presented by members of B&C’s renowned TSCA practice group, which includes six former senior EPA officials; an extensive scientific staff, including seven Ph.D.s; and a robust and highly experienced team of lawyers and non-lawyer professionals extremely well versed in all aspects of TSCA law, regulation, policy, compliance, and litigation.

Online courses are offered at $100 for one-hour modules and $200 for two-hour modules, or $1,400 for the full 12-module training. Courses can be completed at the learner’s own pace, and enrollment is valid for one full year. Interested professionals should visit www.TSCAtutor.com to view sample course segments and purchase modules. Volume discounts are available for companies wishing to purchase courses for multiple employees. Companies interested in live in-person or customized live webinar training should contact .(JavaScript must be enabled to view this email address) to schedule.

For more information about TSCA Tutor™, contact Heidi Lewis at .(JavaScript must be enabled to view this email address).

Tags: TSCA

 

By Lynn L. Bergeson

On April 10, 2020, the U.S. Environmental Protection Agency (EPA) published a quarterly update of the Toxic Substances Control Act (TSCA) confidential business information (CBI) review statistics. The data summarize the number of CBI cases under review and results of completed reviews through March 1, 2020. In addition, a spreadsheet showing the details of completed TSCA CBI determinations through March 1, 2020, is available. EPA states that making this information publicly available “continues to demonstrate the agency’s commitment to transparency while fulfilling its responsibilities under the Lautenberg Act amendments to TSCA.” According to EPA, it has established “numerous new processes, systems, and procedures to enable submitters to provide the information required when making confidentiality claims and to facilitate EPA’s review, and where applicable, determinations on these claims.” The updated statistics show EPA’s progress toward meeting these requirements.

Tags: EPA, TSCA, CBI

 

By Lynn L. Bergeson and Ligia Duarte Botelho, M.A.

On April 9, 2020, EPA issued a final rule amending the Toxic Substances Control Act (TSCA) Chemical Data Reporting (CDR) regulations by extending the 2020 report submission deadline to November 30, 2020. The extension applies to the 2020 submission period only. As many are aware, CDR regulations require manufacturers (including importers) of certain chemical substances to report data on the manufacturing, processing, and use of the chemical substances. This final rule is effective as of April 9, 2020.

This final rule has been published alongside EPA’s CDR Revisions final rule, which includes several changes to make regulatory updates that align with new statutory requirements of TSCA, improve the data collected, and potentially reduce the burden for chemical reporters. The CDR Revisions final rule will be effective on May 11, 2020.

Given the changes to become effective, The Acta Group (Acta®) announced on April 1, 2020, the launch of CDR Cross-Check™, an ingenious yet simple tool developed and offered by Acta to assist companies in preparing for the 2020 CDR required by 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 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.

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

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. (B&C®).

Tags: TSCA, CDR

 

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

The U.S. Environmental Protection Agency (EPA) announced on March 25, 2020, that it will consider a proposed rule that would look at providing exemptions to the Toxic Substances Control Act (TSCA) fees rule in response to stakeholder concerns about implementation challenges. EPA states that by considering a proposal to narrow the broad scope of the current requirements, it “could significantly reduce burden on potentially thousands of businesses across the country while maintaining the ability to successfully implement the Lautenberg Act amendments” to TSCA to protect human health and the environment. According to EPA, it plans to initiate a new rulemaking process to consider proposing exemptions to the current rule’s self-identification requirements associated with EPA-initiated risk evaluations for manufacturers that:

  • Import the chemical substance in an article;
  • Produce the chemical substance as a byproduct; or
  • Produce or import the chemical substance as an impurity.

EPA states that it may also consider proposing other changes to the rule during this process consistent with TSCA’s requirement to reevaluate the fees rule every three years. EPA notes that it believes that considering exempting certain entities from self-identification requirements will not impede the ability to collect fully the necessary fees and will still allow it to achieve the ultimate objective of the TSCA fees rule and the statute -- “to defray a portion of EPA’s TSCA implementation costs.” EPA intends to issue proposed amendments to the current fees rule later in 2020, with the goal of promulgating the amendments in 2021.

EPA states that additionally, “in light of the extremely unusual circumstances of this situation and the undue hardship imposed on certain businesses who would be required to collect and report information” under the TSCA fees rule, EPA issued a “no action assurance” for the three categories of manufacturers at this time. More specifically, EPA “will exercise its enforcement discretion regarding the self-identification requirement for the three categories of manufacturers” for which EPA intends to propose an exemption.

EPA suggests that businesses that are erroneously on the preliminary lists of fee payers or fall into one of the three categories discussed above should see its frequently asked questions (FAQ) for more information about how to certify as such to EPA and to avoid fee obligations. EPA posted more information on its announcement, as well as a copy of the no-action assurance, on its website. More information is available in our March 9, 2020, blog item, “EPA Extends Deadline to Self-Identify as a Manufacturer or Importer of a High-Priority Chemical to May 27.”


 

By Lynn L. Bergeson

EPA published a Federal Register notice on March 20, 2020, inviting the public to nominate scientific experts from a diverse range of disciplines to be considered for appointment to the TSCA Science Advisory Committee on Chemicals (SACC). 85 Fed. Reg. 16094. EPA is seeking nominations of individuals who have demonstrated high levels of expertise in scientific and/or technical fields relevant to chemical safety and risk assessment, including, but not limited to: human health and ecological risk assessment, biostatistics, epidemiology, pediatrics, physiologically based pharmacokinetics, toxicology and pathology, and the relationship of chemical exposures to women, children, and other potentially exposed or susceptible subpopulations. In addition, nominees should have backgrounds and experiences that would contribute to the diversity of scientific viewpoints on the committee, including professional experiences in government, labor, public health, public interest, animal protection, industry, and other groups, as the EPA Administrator determines to be advisable (e.g., geographic location, social and cultural backgrounds, and professional affiliations). Any interested person or organization may nominate qualified persons to be considered for appointment to SACC. Individuals also may self-nominate. The preferred method for submitting nominations is via e-mail to Steven Knott, the SACC’s Designated Federal Officer (.(JavaScript must be enabled to view this email address)). Nominations are due no later than April 20, 2020.

Tags: TSCA, SACC

 

By Lynn L. Bergeson

On March 17, 2020, the U.S. Environmental Protection Agency (EPA) announced the availability of a final rule amending the Chemical Data Reporting (CDR) rule. According to EPA, the amendments are intended to reduce the burden for certain CDR reporters, improve the quality of CDR data collected, and align reporting requirements with the Frank R. Lautenberg Chemical Safety for the 21st Century Act’s (Lautenberg Act) amendments to the Toxic Substances Control Act (TSCA). 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 making 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. The reporting period will still begin on June 1, 2020. EPA will host a webinar on Tuesday, March 31, 2020, to discuss the revised reporting requirements, provide an overview of the 2020 CDR submission period, and to give an introduction to the updated e-CDR web reporting tool. EPA has posted pre-publication versions of the final rules amending the CDR rule and extending the reporting period. More information will be available in a forthcoming memorandum that will be posted on our website.

Tags: CDR, TSCA

 

By Lynn L. Bergeson

The U.S. Environmental Protection Agency (EPA) announced on March 11, 2020, the availability of the latest Toxic Substances Control Act (TSCA) Inventory. EPA states that this biannual update to the public TSCA Inventory is part of its regular posting of non-confidential TSCA Inventory data. According to EPA, this update adds 81 new chemicals, and the Inventory as a whole now contains 86,405 chemicals, of which 41,484 are active in U.S commerce. Other updates to the TSCA Inventory include:

  • Updates to commercial activity data, or active/inactive status;
     
  • Updated regulatory flags, such as consent orders and significant new use rules (SNUR); and
     
  • Additional unique identifiers.
     

EPA notes that the TSCA inventory is a list of all existing chemical substances manufactured, processed, or imported in the United States that do not qualify for an exemption or exclusion under TSCA. More information on the TSCA Inventory is available on EPA’s website.


 

By Lynn L. Bergeson

On March 6, 2020, EPA published its final rule on procedures for review of confidential business information (CBI) claims made under TSCA. 85 Fed. Reg. 13062. 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. EPA sets out the review criteria and related procedures that it will use to complete the reviews within the five-year time frame set in TSCA. The substantiation requirements describe the applicable procedures and provide instructions for regulated entities. The final rule is effective on May 5, 2020. For more information, please read the full B&C memorandum.

Tags: CBI, TSCA

 
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