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By Lynn L. Bergeson and Carla N. Hutton
 
On March 3, 2022, the White House Office of Science and Technology Policy (OSTP) published a request for information (RFI) to support the development of a federal scientific integrity policy framework. 87 Fed. Reg. 12165. According to OSTP, the framework will include assessment criteria that OSTP and agencies can use to inform, review, and improve the content and implementation of agency scientific integrity policies. To support this framework, OSTP seeks information on: (1) how scientific integrity policies can address important and emergent issues, including diversity, equity, inclusion, and accessibility; new technologies; emerging modes of science; and coordination with related policy domains; (2) the criteria to evaluate scientific integrity policy content, implementation, outcomes, and impacts in the Executive Branch; (3) how to ensure that scientific integrity evaluation findings lead to effective iterative improvement of federal scientific integrity policy and practices; and (4) how to ensure the long-term viability and implementation of federal scientific integrity policies, practices, and culture through future administrations. Comments are due April 4, 2022.
 
OSTP states that this effort builds on the Scientific Integrity Task Force’s review of existing scientific integrity policies and practices, released in the January 11, 2022 report, Protecting the Integrity of Government Science. As reported in our January 13, 2022, blog item, the scientific integrity principles and best practices identified in the report “aim to ensure that science is conducted, managed, communicated, and used in ways that preserve its accuracy and objectivity and protect it from suppression, manipulation, and inappropriate influence -- including political interference.”


 

By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) announced on February 4, 2022, the release of a “new and improved” Framework for the Assessment of Environmental Performance Standards and Ecolabels for Federal Purchasing under its Environmentally Preferable Purchasing (EPP) program, as well as a webpage highlighting ecolabel criteria that address per- and polyfluoroalkyl substances (PFAS). EPA states that “[t]hese actions are a key step in implementing President Biden’s Executive Order on Catalyzing Clean Energy Industries and Jobs through Federal Sustainability and the accompanying Federal Sustainability Plan.
 
According to EPA, the EPP program helps federal government purchasers use private sector standards and ecolabels to identify and procure environmentally preferable products and services via the Recommendations of Specifications, Standards, and Ecolabels for Federal Purchasing. The updated Framework provides a streamlined, transparent, and consistent approach to assessing marketplace standards and ecolabels for environmental sustainability and for inclusion into the Recommendations.
 
EPA states that the updates to the Framework reflect lessons learned during the last five years of implementation and a desire to address a broader range of purchase categories with a more streamlined set of criteria. In addition, EPA updated the eligibility criteria for standards and ecolabels to support further their implementation across the federal government. EPA will use the Framework to update and expand the Recommendations to support the Biden Administration’s priorities and the Federal Sustainability Plan. The Recommendations currently include more than 40 private sector environmental performance standards and ecolabels in 25 purchase categories.
 
EPA will hold a webinar on March 2, 2022, at 2:00 p.m. (EST) to provide more information on the updated Framework and initial plans to expand the Recommendations. Stakeholders can register for the webinar and provide questions in advance.
 
EPA notes that the webpage highlighting how EPA’s Recommendations of Specifications, Standards, and Ecolabels address PFAS “is an important step toward providing federal purchasers with tools to avoid procurement of products containing PFAS.” The release of the webpage is concurrent with work to identify products and purchase categories that are known to be associated with key PFAS uses, as well as outreach to ecolabel and standard organizations regarding addressing PFAS.


 

By Lynn L. Bergeson and Margaret R. Graham

On December 18, 2018, the U.S. Court of Appeals for the Ninth Circuit (Ninth Circuit) issued an order granting in part respondent U.S. Environmental Protection Agency’s (EPA) motion for partial voluntary remand of certain provisions of its final rule on Procedures for Chemicals Risk Evaluation under the Toxic Substances Control Act (TSCA).  Specifically, EPA’s motion for partial voluntary remand, filed August 6, 2018, sought remand with vacatur of 40 C.F.R. Section 702.31(d) (Penalty Provision) and remand without vacatur of 40 C.F.R. Sections 702.37(b)(4) (Relevancy Provision) and 702.37(b)(6) (Consistency Provision).  The Ninth Circuit granted EPA’s motion to remand and to vacate the Penalty Provision, but referred EPA’s motion to remand without vacatur for the Relevancy and Consistency Provisions.  The Penalty Provision states that “[s]ubmission to EPA of inaccurate, incomplete, or misleading information pursuant to a risk evaluation … is a prohibited act … subject to penalties.”

EPA stated in its motion that its “request to remand the Penalty, Relevancy, and Consistency provisions is reasonable, timely, and will serve the interests of judicial economy,” but it has not yet decided on a specific course of action.  EPA sought remand to address the potential concerns that petitioners stated in their opening brief.  EPA stated that vacatur was only appropriate for the Penalty Provision, however, as “nothing in the proposed rule or rulemaking record gave any indication that EPA was contemplating extending the Penalty Provision beyond manufacturers, and EPA did not purport to make that change in response to public comments, the Penalty Provision is not a logical outgrowth of the proposed rule.” 

As for the Relevancy and Consistency Provisions, EPA stated that they should be remanded but not vacated for the following reasons:

  1. EPA believes that the concerns about these provisions can be addressed through modifications to the language of the regulations;
  2. The unintended consequences of the Relevancy and Consistency Provisions that Petitioners allege are not serious; even if a manufacturer were to rely on those provisions to withhold information, EPA has independent authority to collect that information or require development of new information as needed to conduct its risk evaluations; and
  3. The disruptive effects to EPA could be considerable if these regulations were vacated while EPA completes its remand process; if the provisions are vacated, manufacturers could (intentionally or unintentionally) submit junk science or irrelevant material, requiring EPA to consume limited resources and take time out of the statutorily-mandated schedule to review the information.  Further, vacatur of the Relevancy Provision would be particularly disruptive because it would eliminate altogether the affirmative requirement for manufacturers to submit lists of information when requesting risk evaluations; and could delay EPA’s information gathering if it had to request or order such information from the outset.

More information on the appeals to the TSCA framework rule on risk evaluation is available on our blog.


 

By Lynn L. Bergeson and Margaret R. Graham

On March 6, 2018, in the U.S. Court of Appeals for the D.C. Circuit, the Environmental Defense Fund (EDF) filed its Principal Brief in the litigation case that petitions for review the U.S. Environmental Protection Agency’s (EPA) Toxic Substances Control Act (TSCA) Inventory Notification (Active-Inactive) Requirements final rule (EDF v. EPA, No. 1701 (D.C. Cir.)).

EDF’s brief includes, among other required statements, a statement of the issues, a statement of the case, a summary of their argument, and their argument.  EDF’s arguments are as follows:

  1. The Inventory Rule withholds information on chemical substances manufactured or processed in the U.S. from the public; this information is required to be disclosed under amended TSCA; EDF has been harmed by EPA’s failure to disclose this information and to disclose unique identifiers for confidential chemicals; and the court can redress this harm.  
  2. The final rule illegally allows manufacturers and processors to assert certain new claims for nondisclosure of specific chemical identities based on other persons having asserted earlier claims, which is contrary to TSCA’s plain text and the relevant precedent governing confidentiality claims; and EPA’s rationale for its interpretation is arbitrary and capricious.
  3. The final rule violates both the substantive and procedural requirements of TSCA Section 14, Confidential Information, specifically that:  EPA refused to accept that TSCA Section 8, Reporting and Retention of Information, repeatedly incorporates Section 14 requirements for confidentiality claims; the final rule fails to implement one of the substantive requirements for confidentiality claims under Section 14; and the final rule fails to implement one of the substantive requirements for confidentiality claims under Section 14.
  4. The final rule fails to implement the unique identifier and other public information requirements in TSCA Section 8(b)(7)(B).
  5. The final rule exempts chemicals manufactured and processed solely for export from the reporting requirements, even though such chemicals are specifically not exempted from TSCA Section 8.
  6. Finally, EDF requests the court to set aside the rule in part, stating that vacatur, along with remand, is the appropriate remedy for EPA’s violations of the Administrative Procedure Act (APA).  EDF does not seek a complete vacatur, however, stating that “a complete vacatur would postpone the release of some of the very information that EDF seeks, since it would allow EPA to postpone publishing the Inventory based on the information it has already collected.  In addition, it would impose costs on the regulated community beyond those necessary to remedy EDF’s harms [and] those manufacturers and processors who have already filed notices without claims of confidentiality should not need to refile the notices.”  The portions of the final rule that EDF requests the court to vacate are as follows:  the exclusion for export-only manufacturers (40 C.F.R. Section 710.27(a)(4)); Confidentiality Claims (40 C.F.R. Section 710.37); and certain portions of the preamble. EDF states specific instructions on how it would like the court to order EPA to promulgate the regulation on remand that include revisions to regulations on confidentiality claims, public information requirements, and notifications of activities during the lookback period.

EDF has done its usual thorough job and the brief is definitely a must read for TSCA stakeholders.  More information on this proceeding and the other challenges to the TSCA framework final rules is available on our blog under key words framework rules.


 

By Lynn L. Bergeson and Margaret R. Graham

On January 5, 2018, the Natural Resources Defense Council (NRDC) filed a Petition for Review in the U.S. Court of Appeals for the Second Circuit (Second Circuit) of what is characterized as a U.S. Environmental Protection Agency (EPA) “final rule” issued November 7, 2017, entitled “New Chemicals Decision-Making Framework:  Working Approach to Making Determinations under Section 5 of TSCA.”  The Framework Document, as it has come to be called, is the “final rule” at issue and was posted in EPA’s docket opened for comments related to its two Toxic Substances Control Act (TSCA) public meetings that took place in December. It is reasonable to assume that the Framework Document is not referred to by EPA as a final rule and was not published in the Federal Register as a final rule because EPA believes it is a document that outlines a conceptual approach to how EPA may go about making decisions on new chemicals.  EPA specifically states the document, referred to as a “draft” in the Federal Register notice that announced the two public meetings, “outlines EPA’s approach to making decisions on new chemical notices submitted to EPA under TSCA section 5, as amended by the Frank R. Lautenberg Chemical Safety for the 21st Century Act,” and includes EPA’s “general decision framework for new chemicals” and a breakdown of how EPA “intends to approach each of the five types of new-chemical determinations required under the statute.” 

The citizen action petition raises novel and interesting legal questions, and is quite different from the other petitions for review, one for each framework final rule, that are  pending. Whether the newest legal challenge will survive procedural motions that EPA can be expected to file to dismiss the action remains to be seen. More information on the framework rule petitions for review is available on our blog under key phrases framework rules and petition for review


 

By Lynn L. Bergeson and Margaret R. Graham

On December 11, 2017, in the U.S. Court of Appeals for the Fourth Circuit (Fourth Circuit) case on the petition for review of the Toxic Substances Control Act (TSCA) framework rule Procedures for Chemical Risk Evaluation under TSCA (Alliance of Nurses for Healthy Environments v. EPA, Case Nos. 17-1926, 17-2040, and 17-2244 (consolidated)), the Fourth Circuit granted the petitioners’ motions to transfer to the Ninth Circuit.  This was not entirely unexpected, as the U.S. Court of Appeals for the Ninth Circuit (Ninth Circuit) recently denied the U.S. Environmental Protection Agency’s (EPA or respondent) motions to transfer to the Ninth Circuit the consolidated cases on the petition for review of one of the other TSCA framework rules, Procedures for Prioritization of Chemicals for Risk Evaluation (Safer Chemicals, Healthy Families v. EPA, Case Nos. 17-72260, 17-72501, and 17-72968 (consolidated)) to the Fourth Circuit.  Now both of these cases will be decided in the Ninth Circuit.  In the U.S. Court of Appeals for the D.C. Circuit (D.C. Circuit) case on the petition for review of the TSCA framework rule TSCA Inventory Notification (Active-Inactive) Requirements (EDF v. EPA, Case No. 17-1201), neither the petitioner or the respondents have moved to transfer this case so it will in all likelihood stay in the D.C. Circuit.

More information on these petitions for review is available on our blog under key phrases framework rules and petition for review.


 

By Lynn L. Bergeson and Margaret R. Graham

On November 27, 2017, in the U.S. Court of Appeals for the Ninth Circuit (Ninth Circuit) case on the petition for review of the Toxic Substances Control Act (TSCA) framework rule Procedures for Prioritization of Chemicals for Risk Evaluation (Safer Chemicals, Healthy Families v. EPA, Case Nos. 17-72260, 17-72501, and 17-72968 (consolidated)), the Ninth Circuit issued an order on several pending motions.  It granted the American Chemistry Council’s (ACC) (and other industry groups) motion to intervene on behalf of respondent U.S. Environmental Protection Agency (EPA); denied the respondents’ motions to transfer Case Nos. 17-72260 and 17-72501 to the U.S. Court of Appeals for the Fourth Circuit (Fourth Circuit); denied respondents’ requests to hold Case Nos. 17-72260 and 17-72501 in abeyance; granted the motions to consolidate Case Nos. 17-72260, 17-72501, and 17-72968; and set an amended briefing schedule.  The consolidated opening brief is now due January 23, 2018; the consolidated answering brief and the intervenors’ brief are due February 22, 2018; and the optional reply brief is due within 21 days after service of the answering and intervenors’ briefs.

In the Fourth Circuit case on the petition for review of the TSCA framework rule Procedures for Chemical Risk Evaluation under TSCA (Alliance of Nurses for Healthy Environments v. EPA, Case Nos. 17-1926, 17-2040, and 17-2244 (consolidated)), the petitioners’ motions to transfer to the Ninth Circuit are still pending; on November 21, 2017, the Fourth Circuit deferred the ruling until the Ninth Circuit ruled on its own pending motions to transfer.  As the Ninth Circuit has now denied the motions to transfer (per above), the Fourth Circuit will soon make a decision about whether this case should also be heard by the Ninth Circuit.  A new briefing schedule has not been set.

In the U.S. Court of Appeals for the D.C. Circuit (D.C. Circuit) case on the petition for review of the TSCA framework rule TSCA Inventory Notification (Active-Inactive) Requirements (EDF v. EPA, Case No. 17-1201), there are no current delays due to transfers or consolidations.  Respondent EPA filed a motion to extend time to file its brief on November 7, 2017; petitioner Environmental Defense Fund (EDF) filed its statement of intent regarding appendix deferral on November 8, 2017, and filed its initial submissions including the statement of issues on November 8-9, 2017; and respondent EPA filed the certified index to the record on November 27, 2017.  ACC and other industry groups were granted leave to intervene on behalf of respondent EPA on November 13, 2017.  The briefing schedule has not been set. 

More information on these petitions for review is available on our blog under key phrases framework rules and petition for review.


 

By Lynn L. Bergeson and Margaret R. Graham

On September 25, 2017, Petitioners Safer Chemicals Healthy Families and Environmental Defense Fund (EDF) (collectively Petitioners) in Ninth Circuit Case Nos. 17-72260 and 17-72501 (regarding review of the Toxic Substances Control Act (TSCA) framework rule Procedures for Prioritization of Chemicals for Risk Evaluation) filed a joint opposition to the U.S. Environmental Protection Agency’s (EPA) motion to transfer to the Fourth Circuit and hold cases in abeyance.  On September 14, 2017, EPA filed a motion for these Ninth Circuit cases to be moved to the Fourth Circuit where there is currently another challenge to a TSCA framework rule (Alliance of Nurses for Healthy Environments, et al. v. EPA, Case Nos. 17-1926, et al.; Petition for Review of Procedures for Chemical Risk Evaluation under TSCA).  Petitioners oppose EPA’s request for the case to be moved to the Fourth Circuit, stating that “Congress expressly gave Petitioners the right to select a forum” and “eleven of the fifteen Petitioners elected to file their petition in [the Ninth Circuit] … now believe that both sets of petitions should be consolidated in this Court.”  The Motion to Intervene of American Chemistry Council, et al. on EPA’s behalf is still pending.  On September 25, 2017, EPA filed a response to the motion to intervene stating that they took no position on it.  The Petitioner’s briefs in both cases are still due October 30, 2017.

On September 28, 2017, in Fourth Circuit Case Nos. 17-1796, et al. (referenced above), the court granted the Motion to Intervene on EPA’s behalf of American Chemistry Council, et al.  A new briefing schedule has still not been set. 

On September 29, 2017, in D.C. Circuit Case No. 17-1201 (EDF v. EPA; Petition for Review of TSCA Inventory Notification (Active-Inactive) Requirement), EPA filed a motion to extend deadlines in scheduling order, stating that “in light of the potential for other parties to file additional petitions in this Court until October 24, 2017, the parties now jointly request that the Court extend all deadlines in the Court’s September 5, 2017, order by an additional 35 days.”  The court has not ruled on EPA’s request yet; if it denies it, the briefing schedule will begin on October 5, 2017.

More information on these petitions for review is available on our blog under key phrases framework rules and petition for review.   


 

By Lynn L. Bergeson and Margaret R. Graham

On September 20, 2017, the U.S. Environmental Protection Agency (EPA) issued a notice in the Federal Register stating that it is extending the compliance date by which submitters of Toxic Substances Control Act (TSCA) submissions containing information claimed as Confidential Business Information (CBI) and filed between June 22, 2016, and March 21, 2017, had to submit to EPA the substantiation required by TSCA Section 14(c)(3) for all information claimed as confidential, other than information exempt from substantiation pursuant to TSCA Section 14(c)(2).  82 Fed. Reg. 43964.  The new deadline for substantiation of these claims is October 19, 2017.  EPA states that this extension is in response to “concerns raised by industry stakeholders regarding the ability for companies to meet the previous September 19, 2017, deadline due to recent severe weather events,” and that it is “providing this additional flexibility for stakeholders because of the impacts of hurricanes Harvey and Irma.”  Further, “because EPA published its interpretation that TSCA section 14(c)(3) requires up front substantiation after some companies had already asserted confidentiality claims subject to TSCA section 14(c)(3), the Agency set a future deadline for submission of substantiations pertaining to those submissions.” 

More information on the CBI substantiation process is available in our memorandum The September 19th CBI Substantiation Deadline Fast Approaching.

Also on September 20, 2017, EPA announced it was scheduling three webinars to assist the regulated community with reporting under the TSCA Inventory Notification (Active-Inactive) rule.  The webinars, scheduled for September 27, 2017, October 25, 2017, and November 29, 2017, from 1:00 p.m. - 3:00 p.m. (ET), will be identical and will include an overview of reporting requirements, a demo of the electronic reporting application (Central Data Exchange (CDX)), and will provide time for questions and answers.  Registration for the webinars is not required.  EPA’s TSCA Inventory webpage contains the information on how to access the webinar.

More information on the TSCA Inventory Notification (Active-Inactive) rule is available in our memorandum EPA Issues Final TSCA Framework Rules.


 

By Lynn L. Bergeson and Margaret R. Graham

On September 14, 2017, the U.S. Environmental Protection Agency (EPA) filed a motion in the two Ninth Circuit Court of Appeals cases regarding review of the EPA Toxic Substances Control Act (TSCA) framework rule Procedures for Chemical Risk Evaluation under TSCA:  Safer Chemicals Healthy Families v. EPA, Case No. 17-72260 (filed August 10, 2017); and Environmental Defense Fund v. EPA, Case No. 17-72501 (filed September 6, 2017), requesting that the cases be transferred to the Fourth Circuit and to hold the cases in abeyance.  In the motion, EPA states three reasons why these cases should be transferred:

  1. "It is in the interest of judicial economy for the same court to hear the challenges to both EPA Rules,” and “[a]lthough the two Rules are distinct and have separate administrative records, the parties anticipate that there will be some overlap of issues.”
  2. “It would be more convenient for the parties and conserve travel resources for these cases to be heard in the Fourth Circuit, because all counsel of record are located in Washington, DC, or New York.”
  3. “The Fourth Circuit may be able to resolve the petitions for review more quickly than this Court given the respective complexity of the courts’ dockets.”

In this motion, EPA also requests for these cases to be held in abeyance as it “will conserve party resources to wait until resolution of EPA’s motion to transfer before completing any scheduled filings, particularly because the two have different schedules” and “the deadline for interested persons to file petitions for review of the Prioritization and Risk Evaluation Rules has not yet expired…. additional petitions for review … could be filed as late as October 2, 2017.” 

In Case No. 17-72260, Petitioners’ briefs are due October 30, 2017, and Respondent EPA’s briefs are due November 28, 2017.  A briefing schedule has not been scheduled yet in Case No. 17-72501.  On September 11, 2017, in Alliance of Nurses for Healthy Environments, et al. v. EPA, Case No. 17-1926, the Fourth Circuit case regarding review of EPA’s TSCA framework rule Procedures for Chemical Risk Evaluation under TSCA, the Fourth Circuit rescinded the briefing schedule.  A new briefing schedule has not been set. 

More information on these petitions for review is available on our blog under key phrases framework rules and petition for review.  


 
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