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

One of several changes to the Toxic Substance Control Act (TSCA) Chemical Data Reporting (CDR) rule, issued in final on April 9, 2020, is that in the 2020 cycle, 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. As in years’ past, EPA states in its final rule that if no report is filed, both the contracting and producing companies will be held liable if no reporting occurs. Under past CDR cycles, EPA would accept reporting from either the contracting manufacturer or the producing (formerly referred to as “toll”) manufacturer. 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.

EPA stated in the preamble to the final CDR rule that it chose to include two different reporting methodologies for a co-manufacturing situation, indicating that the methodologies are based on a desire to reduce reporting burden and maintain flexibility for both the contracting and producing company. EPA noted that the companies must work together to select between the methodologies for preparing their CDR methodologies. The two methodologies for reporting, codified at 40 C.F.R. Section 711.22(c), are:

(1) The contracting company initiates the required report for that site [defined by EPA at 40 C.F.R. §711.3 as the location where the chemical substance is physically manufactured for chemical substances co-manufactured] as the primary submitter. The contracting company must indicate on the report that this is a co-manufacturing situation, notify the producing company, and record the production volume domestically co-manufactured as set forth in §711.15(b)(3) and processing and use information set forth in §711.15(b)(4). Upon notification by the contracting company, the producing company must also record the production volume domestically co-manufactured and complete the rest of the report as prompted by e-CDRweb.

(2) Upon written agreement between the contracting company and the producing company, the producing company completes the full report for the co-manufactured chemical. The contracting company supplies the information not otherwise known to or reasonably ascertainable by the producing company.

In both cases, the producing company (toll manufacturer) must provide the manufacturing details. There is no mechanism for the contracting company to submit the entire Form U.

More information on the final CDR rule is available in our March 19, 2020, memorandum, “EPA Releases Final Amendments to CDR Rule, Extends Reporting Period.”

Tags: CDR, TSCA

 

By Lynn L. Bergeson

On May 12, 2020, EPA released the signed final rule updating the definition of small manufacturers, including a new definition of what is considered a small government, used to determine reporting and recordkeeping requirements under TSCA. According to EPA, the updated definitions will reduce reporting burdens on chemical manufacturers and small governments while maintaining the Agency’s ability to receive the information it needs to understand exposure to chemical substances manufactured in the United States. The final rule makes a technical correction to the small manufacturer reference at 40 C.F.R. Section 704.104 for hexafluoropropylene oxide, which only includes a rule-specific small processor definition and not a small manufacturer definition. When reviewing the small manufacturer size standards, EPA found this to be an “inadvertent error.” The final rule also updates the current small manufacturer definition in the Preliminary Assessment Information Rule (PAIR) at 40 C.F.R. Section 712.25 to align it with the updated small manufacturer definition at 40 C.F.R. Section 704.3.

EPA notes that the updated definitions will apply to the CDR rule reporting period beginning June 1, 2020, and will impact certain reporting and recordkeeping requirements for TSCA Section 8(a) rules. EPA states that the final rule is based on 2018 dollars to ensure that the definition is as up to date as possible at the time of promulgation. The final rule will be effective 30 days after publication in the Federal Register. EPA has posted the pre-publication version of the final rule on its website.

More information on CDR reporting is available in our May 13, 2020, blog item, “New Reporting Procedure for Co-Manufacturers under TSCA CDR Rule May Catch Certain Manufacturers Off Guard,” and our March 19, 2020, memorandum, “EPA Releases Final Amendments to CDR Rule, Extends Reporting Period.”

Tags: CDR, TSCA

 

By Lynn L. Bergeson

EPA will host a webinar on May 19, 2020, from 1:00 p.m. to 3:00 p.m. (EDT) to provide an overview of the 2020 CDR requirements. 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. 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, CBI, TSCA

 

By Lynn L. Bergeson

The 2020 GlobalChem webinar series addresses major developments in chemicals management and provides participants a chance to engage with policymakers and other key experts throughout the chemical industry value chain. On May 13, 2020, at 12:00 p.m. (EDT), Richard E. Engler, Ph.D., Director of Chemistry, Bergeson & Campbell, P.C. (B&C®), will present during the “TSCA New Chemicals” webinar. Other presenters include Lynn Dekleva, Ph.D., Associate Deputy Assistant Administrator for New Chemicals, U.S. Environmental Protection Agency (EPA) Office of Chemical Safety and Pollution Prevention (OCSPP), Tala Henry, Ph.D., Deputy Director, EPA Office of Pollution Prevention and Toxics (OPPT); Mike Walls, Vice President, Regulatory and Technical Affairs, American Chemistry Council (ACC); and Ritesh Tiwari, Chemical Engineer, EPA. The webinar will address key changes in the Section 5 program and challenges faced by EPA and submitters, including information requirements, assessment of risks, and practical tips. Register for the 10-part webinar series online. B&C is a proud sponsor.


 

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.”


 
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