The Biobased and Renewable Products Advocacy Group (BRAG) helps members develop and bring to market their innovative biobased and renewable chemical products through insightful policy and regulatory advocacy. BRAG is managed by B&C® Consortia Management, L.L.C., an affiliate of Bergeson & Campbell, P.C.

By Lynn L. Bergeson

On November 25, 2020, EPA announced the amendment of the Toxic Substances Control Act (TSCA) Chemical Data Reporting (CDR) regulations by extending the submission deadline for 2020 reports. CDR submissions are now due on January 29, 2021. According to EPA, this is the final extension, and it only applies to 2020 submissions. CDR regulations require manufacturers of certain chemical substances included on the TSCA Chemical Substance Inventory to report data on the manufacturing, processing, and use of chemical substances.

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 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 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.

Tags: TSCA, CDR, Deadline

 

We are pleased to announce that the American Bar Association (ABA) Section of Environment, Energy, and Resources published an article written by Lynn L. Bergeson and Eve C. Gartner entitled “The essentials of TSCA practice” in the November/December 2020 issue of Trends. According to the authors, legal practitioners should be aware of the commercial, legal, and reputational implications of TSCA as amended by the Frank R. Lautenberg Chemical Safety for the 21st Century Act in 2016. The authors state that TSCA’s expanded commercial reach “is an important, consequential, and growing practice area.” The authors note that “[c]ommunity organizations representing populations at greater risk of harm from chemicals should also be aware that TSCA may offer much-needed protections.”

Tags: TSCA, ABA

 

After reading the article below by Jeffery Morris, former Director of the U.S. Environmental Protection Agency’s (EPA) Office of Pollution Prevention and Toxics (OPPT), we were inspired to post it. We appreciate having the opportunity to share his analysis with our audience.

TSCA as a Gap-Filling Statute: Potentially Exposed and Susceptible Subpopulations

By Jeffery Morris, PhD

In its response to public comments on the scope documents for its next twenty chemical risk evaluations conducted under the Toxic Substances Control Act (TSCA), the US Environmental Protection Agency (EPA) has asserted that TSCA is a “gap-filling statute” for the regulation of chemical substances in the United States (US EPA, Summary of Public Comments Received on the Draft Scopes of the Risk Evaluations for Twenty Chemical Substances Under the Toxic Substances Control Act (TSCA), August 2020, p. 13). This assertion relates to the regulatory nexus between TSCA and other federal statutes. At issue regarding regulatory nexus is whether TSCA’s role is to: (1) fill gaps where issues are not addressed by other laws that regulate chemicals1, (2) serve as the nation’s primary and preeminent statute for chemicals, or (3) operate somewhere between these two positions. Inherent in the TSCA-as-gap-filler position is the view that federal laws should work together to advance the public welfare, and that different environmental statutes have their own strengths in how they govern the impact of chemicals on people and the environment.

TSCA requires the consideration of potentially exposed or susceptible subpopulations in the EPA’s evaluation of chemicals. While TSCA is not the only environmental law with provisions for susceptible or vulnerable subpopulations, the direct, repeated emphasis across multiple sections of the law that the EPA consider potentially exposed or susceptible subpopulations may be unique in US environmental law. Therefore, how the EPA meets this requirement with respect to other laws’ treatment of such populations is an important consideration for regulatory nexus. Key questions regarding regulatory nexus and TSCA’s role are how to go about identifying whether other statutes leave gaps in this area for TSCA to fill and if they do, how those gaps should be filled in the EPA’s chemical evaluations.

The recently released final scope documents and the accompanying response-to-comments document do not fully answer these questions, including regarding comments that have been raised about how the EPA will apply exposure and susceptibility considerations to people living in communities located near high concentrations of chemicals-related activity. My hope is that exploring these questions now can help inform a path forward for further addressing comments the EPA has received on potentially exposed or susceptible subpopulations as the twenty draft risk evaluations are developed, as well as in scope documents for future chemicals brought into the TSCA prioritization process.

In its response to scope document comments, the EPA makes two important statements regarding the regulatory nexus issue as applied to potentially exposed or susceptible subpopulations. The first, on page 13, is that “EPA believes that coordinated action on exposure pathways and risks addressed by other EPA-administered statutes and regulatory programs is consistent with statutory text and legislative history, particularly as they pertain to TSCA’s function as a ‘gap-filling’ statute ….” In the second statement, also on page 13, the EPA adds that “[t]o the extent that specific exposure pathways are not under the jurisdiction of other EPA-administered statutes and associated regulatory programs, EPA plans to evaluate those exposures in the risk evaluations for the individual substances.”

The first statement’s focus on “coordinated action” between laws and regulations with respect to chemical evaluation and management is a crucial consideration for regulatory nexus. Coordination by the EPA’s Office of Chemical Safety and Pollution Prevention (OCSPP), which administers TSCA, with other EPA offices that manage statutes that address chemicals, as well as with other federal agencies that implement laws impacting chemicals, is good government practice. What is missing from the final scope documents, and therefore would be a valuable addition to the chemical-specific dockets, is a detailed description of the type of coordination cited in the response to comments. Ideally, this description would appear in the scope documents, but for these twenty chemicals an addition to the dockets would be helpful. For example, the EPA could strengthen its explanation of whether potential exposures or susceptibilities are based on geography (e.g., exposures are higher in a particular location), biology (e.g., a particular population has a genetic or otherwise biologically based predisposition to suffer adverse effects from exposure to a chemical), or cultural/societal factors (e.g., a cultural or community practice results in exposure potential greater than in the general population, or an attribute of the subpopulation’s location in society, such as having low income or poor access to health care, creates susceptibilities to adverse effects from chemical exposure).

Because some comments on community exposures refer specifically to 1,3-butadiene, it is a useful example to illustrate the challenges and opportunities presented by the coordination the EPA is conducting within the regulatory nexus construct; it also can illustrate what I mean by a detailed description of cross-office coordination on potentially exposed or susceptible subpopulations. This example looks at just one of 1,3-butadiene’s uses: in the production of tires. Under its Clean Air Act (CAA) authority, the EPA’s Office of Air and Radiation (OAR) conducted a Residual Risk Assessment for the Rubber Tire Manufacturing Source Category in Support of the 2020 Risk and Technology Review Final Rule (EPA-HQ-OAR-2019-0392-0047, February 2020) that includes 1,3-butadiene within this source category, among numerous other chemical substances designated as hazardous air pollutants (HAP). This assessment supports a July 24, 2020, final rule, National Emission Standards for Hazardous Air Pollutants: Rubber Tire Manufacturing Residual Risk and Technology Review (EPA-HQ-OAR-2019-0392; FRL 10008-48-OAR, 85 FR 44752, July 24, 2020).

The coordination challenge, therefore, is to crosswalk the CAA review, which covers numerous HAPs within one sector, with a TSCA risk evaluation covering the conditions of use of a single HAP chemical across multiple sectors. On page 49 of the 1,3-butadiene TSCA scope document, the EPA states that air emission pathways are covered under the CAA (Final Scope of the Risk Evaluation for 1,3-Butadiene, EPA Document # EPA-740-R-20-011, August 2020). It would be useful for the 1,3-butadiene record to include a table and/or narrative that describes how, for its TSCA coordination on the consideration of potentially exposed or susceptible subpopulations, OCSPP evaluated the 1,3-butadiene conditions of use against the respective source category-based and any other analyses conducted by OAR that included 1,3-butadiene. Such a crosswalk could serve as a best practice for application of regulatory nexus analysis in the implementation of TSCA. It would also aid in transparency to the public around a very complex but important concept: that although different environmental statutes may use different approaches (e.g., sector or source category versus individual chemical analysis), it is possible to coordinate their respective contributions to chemical evaluation and management so that, if gaps exist, TSCA can play its appropriate role in health and environmental protection.

For instance, OAR’s 2020 final rule states that “the percentage of the population potentially impacted by Rubber Tire Manufacturing emissions is greater than its corresponding nationwide percentage for: African Americans (25 percent for the source category compared to 12 percent nationwide) and below the poverty level (21 percent for the source category compared to 14 percent nationwide)” (page 44759). Strong coordination between TSCA and the CAA would suggest that such information obtained through CAA activities would be helpful to OCSPP in determining how to address the “potentially exposed or susceptible subpopulations” considerations required under TSCA section 6, including as they may apply to TSCA’s gap-filler role in addressing comments to the 1,3-butadiene scope document concerning disproportionate exposure to communities located near high concentrations of chemicals-related activity.

This consideration leads to the EPA’s statement in its response-to-comments document that where there is not overlap with another regulatory jurisdiction, the EPA will evaluate the exposures. Using the above TSCA-CAA coordination example for 1,3-butadiene, a question for OCSPP could be whether the TSCA requirement that the EPA consider potentially exposed or susceptible subpopulations in its risk evaluations is covered by the work done by OAR on 1,3-butadiene, specifically with respect to commenters’ input on community-based impacts. One would assume “covered” to mean that this particular aspect of TSCA’s potentially exposed or susceptible subpopulations requirement has been evaluated and addressed in OAR’s CAA activities, and therefore can be excluded from the 1,3-butadiene risk evaluation. However, if the CAA has not addressed this particular TSCA requirement in a manner or to an extent intended by the best read of TSCA’s language regarding the consideration of those potentially exposed or susceptible subpopulations in a particular chemical risk evaluation, then there exists a gap that TSCA, as a gap-filling statute, should address.

The manner in which a TSCA risk evaluation fills any identified gaps is also important. This again will require careful and transparent coordination and analysis between statutes. In its chemical risk evaluations, EPA would presumably want to fill gaps in ways that meet the specific requirements of TSCA for potentially exposed or susceptible subpopulations, without doing so in a manner that is at odds with other statutes’ treatment of a chemical substance under TSCA evaluation. Not only would this careful gap filling be in general sound government practice, but it also would help avoid difficulties if the risk evaluation identifies unreasonable risks that the EPA determines, under TSCA section 9, should be addressed under a law other than TSCA.

The 1,3-butadiene example shows how greater explanation, preferably in scoping documents, on how the EPA coordinates among its offices and other agencies to make regulatory nexus decisions for TSCA risk evaluations can not only provide greater transparency to the public on individual chemical evaluations, but also can inform broader discussions on regulatory nexus by showing how such coordination can identify gaps that TSCA is best situated to fill. For some chemicals, it may be the case that other statutes have already adequately assessed the risks to potentially exposed or susceptible subpopulations, obviating the need for additional analysis in a TSCA risk evaluation. However, the mere existence of another statute with jurisdiction over a particular environmental pathway or human exposure scenario for a chemical substance subject to TSCA review should not lead to an a priori assumption that there is not an evaluation gap for TSCA to fill. Any assumptions about other statutes’ coverage of TSCA’s chemical evaluation requirements should be explored, tested, and fully described in TSCA chemical scope documents or elsewhere in the risk evaluation record. This is particularly important with potentially exposed or susceptible subpopulations, given TSCA’s unique approach to requiring their consideration in chemical prioritization, evaluation, and management. I would argue that a good starting point for articulating TSCA’s gap-filling role is in the application of these requirements to people living near high concentrations of chemicals-related activity.

1 By “chemicals” I refer in this article to chemicals regulated under TSCA, and not to chemicals that are regulated under other federal statutes, such as pesticides, drugs, and food additives.


 

By Lynn L. Bergeson 

On August 17, 2020, EPA’s Office of Inspector General (OIG) published a report entitled Lack of Planning Risks EPA’s Ability to Meet Toxic Substances Control Act Deadlines. OIG conducted an audit to determine whether EPA met the deadlines already imposed by the Frank R. Lautenberg Chemical Safety for the 21st Century Act (Lautenberg Act) in 2016, which amended the Toxic Substances Control Act (TSCA), and whether EPA has the staff, resources, and management controls in place to meet future statutory deadlines. OIG found that while EPA met several of its TSCA deadlines, it did not complete all ten required existing chemical risk evaluations by the June 19, 2020, deadline. OIG recommends that the assistant administrator for Chemical Safety and Pollution Prevention publish the annual existing chemical plan, including the anticipated implementation efforts and required resources; conduct a workforce analysis to assess the Office of Pollution Prevention and Toxics’ (OPPT) capability to implement the TSCA requirements; and specify what skill gaps must be filled in fiscal year 2021 to meet the TSCA requirements. More information is available in our August 18, 2020, blog item.

Tags: OIG, TSCA

 

By Lynn L. Bergeson

From June 15-19, 2020, the American Chemical Society (ACS) will be hosting its annual Green Chemistry and Engineering (GC&E) Conference virtually. On June 15, 2020, from 1:00 p.m. to 4:30 p.m. (EDT), during the “Enabling a Circular Economy for Materials in the Consumer Goods Industry,” Richard E. Engler, Ph.D., B&C’s Director of Chemistry, will proudly present his abstract titled “Road-map for Innovators - Commercialization in a Circular Economy.”

In addition, Engler will present a poster titled “TSCA Tutor -- The Importance of Regulatory Awareness and Applications” on each day of the conference, from 12:00 p.m. to 12:55 p.m. (EDT). The poster presentation will highlight B&C’s complete suite of TSCA Tutor® regulatory training courses online and on-demand. This year’s conference registration is free, so check out Engler’s abstract and poster presentations!

B&C will also have a virtual exhibitor booth concurrent with the poster session mentioned above where attendees can learn more about B&C’s services, BRAG, and B&C’s affiliates The Acta Group and BCCM. Join us during our live sessions to discover more! If those times do not work for you, check us out during one of the conference’s networking breaks daily from 2:45 p.m. to 3:05 p.m. (EDT).


 

By Lynn L. Bergeson

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 the United States commerce. Other updates to the TSCA Inventory include updates to commercial activity data and regulatory flags, such as consent orders and significant new use rules (SNUR).


 

By Lynn L. Bergeson

On May 28, 2020, the U.S. Environmental Protection Agency (EPA) announced the issuance of the final rule amending the definition of small manufacturer, including a new definition for small government in accordance with the Toxic Substances Control Act (TSCA). Effective June 29, 2020, these amendments affect certain reporting and recordkeeping requirements in the Chemical Data Reporting (CDR) rule under TSCA.

Tags: TSCA, CDR

 

From the current impacts of the Toxic Substances Control Act (TSCA) on science policies to challenges faced by industry, Lautenberg Implementation continues to evolve even four years after becoming law. B&C, The Environmental Law Institute (ELI), and the George Washington University (GWU) Milken Institute School of Public Health are pleased to present “TSCA Reform -- Four Years Later,” a complimentary virtual seminar bringing together government and industry officials to reflect on the accomplishments and challenges since the implementation of the 2016 Lautenberg Amendments and where TSCA stands today.

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. Confirmed speakers include:

  • Alexandra Dapolito Dunn, Assistant Administrator, Office of Chemical Safety and Pollution Prevention (OCSPP), EPA
  • Eve C. Gartner, Managing Attorney, Toxic Exposure & Health Program, Earthjustice
  • Lynn R. Goldman, Michael and Lori Milken Dean and Professor, Environmental and Occupational Health, Milken Institute School of Public Health, GWU
  • Jennifer Sass, Senior Scientist, Healthy People & Thriving Communities Program, Natural Resources Defense Council (NRDC)

Mark your calendar for Wednesday, June 24, 2020, 9:30 a.m. - 4:30 p.m. (EDT),to join ELI, B&C, the GWU Milken Institute School of Public Health, leading experts, and distinguished keynote speakers in a day-long exploration of the issues and regulations surrounding TSCA. Registration is free and open to the public, but an ELI account (no charge) is required.

Tags: TSCA, Seminar, B&C

 

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

 
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