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.
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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.


 
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By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) Office of Enforcement and Compliance Assurance (OECA) issued a January 2022 enforcement alert entitled “Violations May Put Ski Wax Users at Risk from Illegal Perfluoroalkyl Substances.” According to the enforcement alert, EPA has identified several high-performance ski wax consumer products that contain perfluorinated chemicals that were not reviewed by EPA for health risks under the Toxic Substances Control Act (TSCA). EPA notes that these wax products are intended for use on sports equipment to enhance the performance of the equipment’s slick surfaces that are in contact with snow. The alert states that:

  • EPA is concerned that recently identified TSCA violations may be putting skiers and wax applicators at risk for exposure to certain persistent and bioaccumulative chemicals; and
     
  • EPA advises sellers of ski wax to ensure that the products they sell do not contain certain perfluorinated chemicals that are not on the TSCA Inventory or have prohibitions on their use in sporting goods.

The enforcement alert states that EPA identified several manufacturers, importers, and sellers that produced or sold ski wax products that included certain perfluorinated chemicals in violation of TSCA, which prohibits the manufacture, processing, or importation of a chemical that is not on the TSCA Inventory or otherwise exempt. TSCA requires anyone who intends to manufacture (including import) a new chemical substance for a non-exempt commercial purpose to submit a premanufacture notice (PMN) at least 90 days prior to the manufacture, import, or processing of the chemical. According to the alert, review of the risks from per- and polyfluoroalkyl substances (PFAS) in ski waxes “is particularly important in light of the potential for ski wax technicians and recreational skiers who apply waxes to the skis to be exposed to PFAS from handling the waxes and from vapors released when the waxes are melted and applied to skis.” The alert notes that PFAS may enter the environment from the use of waxed skis and from the ski wax shavings scraped off during application.
 
The enforcement alert describes the following best practices for assessing whether a wax product contains a new chemical substance: (1) reviewing the product’s safety data sheet (SDS) and comparing the chemical substances against the TSCA Inventory; (2) contacting manufacturers and suppliers for additional chemical identity information where there is uncertainty regarding whether a chemical is on the TSCA Inventory; and (3) contacting EPA via the TSCA Hotline if it remains unclear whether a chemical substance is on the TSCA Inventory.
 
The enforcement alert provides information on EPA’s Audit Policy, under which regulated entities that voluntarily discover, promptly disclose, expeditiously correct, and take steps to prevent recurrence of potential violations may be eligible for a reduction or elimination of any civil penalties that otherwise might apply. The alert states that most violations can be disclosed and processed via EPA’s automated online “eDisclosure” system. According to the alert, many states also offer incentives for self-policing, and EPA suggests checking with the appropriate state agency for more information.


 
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By Lynn L. Bergeson and Carla N. Hutton
 
On February 10, 2022, the U.S. Environmental Protection Agency (EPA) extended the comment period on the draft scope of a risk evaluation under the Toxic Substances Control Act (TSCA) for Asbestos Part 2: Supplemental Evaluation Including Legacy Uses and Associated Disposals of Asbestos. 87 Fed. Reg. 7833. As reported in our December 30, 2021, memorandum, in the Part 2 risk evaluation, EPA will evaluate the conditions of use of asbestos (including other types of asbestos fibers in addition to chrysotile) that EPA had excluded from Part 1 as legacy uses and associated disposals, as well as any conditions of use of asbestos in talc and talc-containing products. The draft scope includes the conditions of use, hazards, exposures, and the potentially exposed or susceptible subpopulations (PESS) that EPA plans to consider in conducting the risk evaluation for this chemical substance. EPA seeks additional data or information that could be useful to EPA in preparing the final scope of the risk evaluation. Comments are now due March 1, 2022.


 
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By Lynn L. Bergeson and Carla N. Hutton
 
On February 8, 2022, the U.S. Environmental Protection Agency (EPA) announced the availability of and solicited public comment on an Information Collection Request (ICR) that EPA is planning to submit to the Office of Management and Budget (OMB): “Notification of Substantial Risk of Injury to Health and the Environment under the Toxic Substances Control Act (TSCA),” identified by EPA ICR No. 0794.17 and OMB Control No. 2070-0046. 87 Fed. Reg. 7173. The ICR represents the renewal of an existing ICR that is currently approved through October 31, 2022. Before submitting the ICR to OMB for review and approval under the Paperwork Reduction Act (PRA), EPA is soliciting comments on specific aspects of the information collection activities and burden estimates. Comments are due April 11, 2022.
 
Under TSCA Section 8(e), any person who manufactures (including imports), processes, or distributes in commerce a chemical substance or mixture and who obtains information that reasonably supports the conclusion that such substance or mixture presents a substantial risk of injury to health or the environment is required to inform EPA immediately of such information unless they have actual knowledge that EPA has been adequately informed of such information. There is also an option for those who wish to submit voluntarily “For Your Information” (FYI) notices. More information on TSCA Section 8(e) requirements is available in our TSCA frequently asked questions (FAQ).
 
EPA estimates that the total estimated number of potential respondents is 51 and that the total estimated average number of responses for each respondent is 343. There is a decrease of 3,847 hours from the last approval (from 21,412 to 17,565 hours). According to EPA, this reflects an overall decrease in the number of Section 8(e) and FYI submissions, which decreased from 408 to 343 Section 8(e) submissions and 13 to six FYI submissions, respectively. EPA has also increased the total annual costs due to an increase in the hourly wages and a change in the methodology to calculate loaded wages (wages plus fringe benefits and overhead).
 
EPA notes that in addition, OMB has requested that it move toward using the 18-question format for ICR Supporting Statements used by other federal agencies and departments that is based on the submission instructions established by OMB in 1995, replacing the alternate format developed by EPA and OMB prior to 1995. EPA states that it does not expect this change in format to result in substantive changes to the information collection activities or related estimated burden and costs.


 
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By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) announced on February 7, 2022, that registration is now open for the March 15-17. 2022, meeting of the Science Advisory Committee on Chemicals (SACC) to peer review EPA’s “Draft TSCA Screening Level Approach for Assessing Ambient Air and Water Exposures to Fenceline Communities Version 1.0” (screening level methodology). As reported in our January 24, 2022, memorandum, EPA will use the screening level methodology to evaluate potential chemical exposures and associated potential risks to fenceline communities in its Toxic Substances Control Act (TSCA) risk evaluations. EPA has extended the comment period to March 22, 2022, to give stakeholders additional time to provide input. EPA “encourages” written comments for consideration by SACC during its peer review be submitted by the original deadline of February 22, 2022. EPA states that it will provide comments submitted after this date to the SACC members, but notes that members “may not have adequate time to consider those comments prior to the meeting’s discussions.” While SACC is unable to consider comments submitted after the March 15-17, 2022, meeting, EPA will consider all comments submitted by March 22, 2022.
 
To provide oral comments during the virtual peer review meeting, registration must be received by 12:00 p.m. (EST) on February 25, 2022. Stakeholders may register as a listen-only attendee at any time until the end of the meeting on March 17, 2022.


 
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By Lynn L. Bergeson and Carla N. Hutton

The U.S. Environmental Protection Agency (EPA) announced on February 3, 2022, that it has resumed publishing notices of substantial risks provided by companies under Section 8(e) of the Toxic Substances Control Act (TSCA) to its ChemView database. EPA states that as the initial phase of its effort to develop an efficient and automated publication process, it started publishing notices received since the procedure lapsed in 2019 due to resource limitations. As resources allow, EPA will “continue to strive” to make non-confidential business information (CBI) versions of TSCA Section 8(e) notices publicly available in ChemView more quickly. EPA’s announcement includes the following questions and answers (Q&A):

What are TSCA section 8(e) notices?

Section 8(e) of TSCA states that “Any person who manufactures, imports, processes, or distributes in commerce a chemical substance or mixture and who obtains information which reasonably supports the conclusion that such substance or mixture presents a substantial risk of injury to health or the environment shall immediately inform the [EPA] Administrator of such information unless such person has actual knowledge that the Administrator has been adequately informed of such information.” 15 U.S.C. 2607(e). EPA guidance defines the term substantial-risk information as information which reasonably supports the conclusion that a chemical substance or mixture presents a substantial risk of injury to health or the environment and ‘‘substantial risk of injury to health or the environment’’ as a risk of considerable concern because of (a) the seriousness of the effect and (b) the fact or probability of its occurrence. Substantial Risk Notifications under TSCA section 8(e) should be submitted within 30 calendar days of obtaining substantial risk information.

The nature and extent of information in TSCA section 8(e) notices varies greatly, ranging from short memos providing limited information to fully detailed laboratory study reports. TSCA 8(e) notices may provide very preliminary data, often on substances that have not yet made it into commercial production. As such, the data provided in TSCA section 8(e) notices can be sparse, incomplete, qualitative or quantitative, and as such, may or may not be amenable to robust review or suitable for use in hazard or risk assessments or regulatory decision-making.

How are TSCA section 8(e) notices obtained by EPA?

TSCA section 8(e) notices (and related “FYI” notices) -- those containing confidential business information (CBI) and non-CBI versions -- are submitted by companies to EPA either electronically via EPA’s Central Data Exchange (CDX) or in hard copy via mail. For more information on submitting TSCA section 8(e) notices: https://www.epa.gov/assessing-and-managing-chemicals-under-tsca/reporting-tsca-chemical-substantial-risk-notice[.]

What does EPA do when it receives a TSCA section 8(e) notice?

Upon receipt of a TSCA section 8(e) notice, these notices are uploaded to the internal Chemical Information System (CIS), EPA’s National Archives and Records Administration (NARA) approved e-record keeping system for TSCA records, including TSCA section 8(e) notices.

How do EPA Risk Assessors Access and Use TSCA section 8(e) notices?

TSCA section 8(e) notices are available to OPPT chemical risk assessors via an internal system, the Chemical Information System (CIS), that makes available any document that is submitted under TSCA to EPA staff. EPA assessors with requisite and up-to-date CBI training and clearance have access to both the CBI and non-CBI versions of TSCA section 8(e) notices as soon as they are uploaded to CIS -- electronically submitted notices are available immediately upon receipt, and paper submissions are typically available within 2 days of receipt. TSCA section 8(e) notices also undergo initial processing which includes entry of information such as effects/endpoint, type of effect, type of test, dose, duration, route of administration, species tested, etc. into an internal database. When the TSCA section 8(e) submission contains sufficient detail, EPA may task its contractor to summarize the human health or ecological hazard information for use in chemical assessments.

Data extracted from TSCA section 8(e) notices may also be incorporated into several internal CBI databases and computational tools (e.g., Analog Identification Methodology, ECOSAR) that are also available to EPA assessors.

EPA risk assessors routinely use the information included in TSCA section 8(e) notices in both TSCA new and existing chemical risk assessment activities. In the new chemicals program, chemicals with toxicity information that was submitted to the Agency via TSCA section 8(e) notices are often used as analogs to “read-across” to assess potential risks to new chemicals that have similar chemical structures but that lack test data. As described previously, TSCA section 8(e) data is also incorporated into AIM or ECOSAR, computational tools used routinely to assess potential risks of new chemicals.

For TSCA section 6 existing chemical risk evaluations, TSCA section 8(e) notices are an integral part of the information included within the TSCA Systematic Review process -- in the gray literature data stream identification and evaluation workflow. For example, the scopes of the risk evaluations for the 20 high priority substances and Manufacturer Requested Risk Evaluations (MRREs) currently underway clearly demonstrate where data from TSCA section 8(e) notices may be included (e.g., in the literature inventory trees and evidence maps). In addition, data contained in TSCA section 8(e) notices have also been used to inform the need for issuance of TSCA section 4 test orders to conduct testing of existing chemicals or to fill data gaps in lieu of conducting new testing.

How can the public access 8(e) notices?

Although not required by statute, EPA has a long history of making data contained in TSCA section 8(e) substantial risk notices publicly available. From 1976-2017, data from TSCA section 8(e) notices were compiled into the TSCATS (Toxic Substances Control Act Test Submissions) and TSCATS2 databases). The TSCATS database information was also made publicly available via the National Library of Medicine (NLM)’s TOXNET. When NLM discontinued TOXNET in December 2019, it made the TSCATS data publicly available for download (https://www.nlm.nih.gov/databases/download/toxlinesubset.html).

In 2013, EPA established its public-facing non-CBI ChemView portal, and began efforts to transfer electronically available non-CBI versions of TSCA section 8(e) notices and the data contained within them (i.e., from the TSCATS databases and/or TOXNET) into ChemView. However, beginning in 2019, EPA was not able to continue the regular publication of TSCA section 8(e) notices to the ChemView database. This heavily manual process was conducted by a single staff person who retired in December 2018. Other staff within the unit that would historically also do this type of work were fully occupied conducting other work to increase transparency associated with TSCA new chemicals submissions in response to a commitment made by the past EPA Administrator to Senator Carper (D-DE).

However, TSCA section 8(e) notices have continued to be available to the public via EPA’s Docket Center. Anyone can make a request to receive non-CBI versions of TSCA section 8(e) notices received by the agency either in person or via email (.(JavaScript must be enabled to view this email address)). Upon request and compilation (which can take time, depending upon the complexity of the request) the docket center will provide the requestor the information via email or other electronic media (e.g., CD). The public may also view paper copies of non-CBI versions of TSCA section 8(e) notices received by the Agency in person at the Docket Center Reading Room (due to COVID, this option is currently by appointment only). Find information about contacting EPA’s docket center reading room.


 
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By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) announced on February 2, 2022, that it is inviting small businesses, governments, and not-for-profit organizations to participate as Small Entity Representatives (SER) for a Small Business Advocacy Review (SBAR) Panel. The Panel will focus on EPA’s development of a rule that would require reporting and recordkeeping for per- and polyfluoroalkyl substances (PFAS) from certain persons who have manufactured (including imported) a PFAS in any year since January 1, 2011.
 
As reported in our June 11, 2021, memorandum, the fiscal year 2020 (FY2020) National Defense Authorization Act (NDAA) amended the Toxic Substances Control Act (TSCA) to add Section 8(a)(7), mandating that EPA promulgate a rule “requiring each person who has manufactured a chemical substance that is a [PFAS] in any year since January 1, 2011” to report certain information. EPA’s proposed rule would require all manufacturers (including importers) of PFAS in any year since 2011 to report information related to chemical identity, categories of use, volumes manufactured and processed, byproducts, environmental and health effects, worker exposure, and disposal. EPA states that the proposed rule will help it better understand the sources and quantities of PFAS manufactured in the United States and support its research, monitoring, and regulatory efforts under the PFAS Strategic Roadmap. Comments on the proposed rule were due September 27, 2021.
 
EPA states that in response to public comments and additional information received during the comment period, it “is interested in convening an SBAR Panel.” The Panel will include federal representatives from the Small Business Administration (SBA), the Office of Management and Budget (OMB), and EPA. According to EPA, the Panel members will ask a selected group of SERs to provide advice and recommendations on behalf of their companies, communities, or organizations to inform the Panel about the potential impacts of the proposed rule on small entities.
 
EPA seeks self-nominations directly from the small entities that may be subject to the rule requirements. Other representatives, such as trade associations that exclusively or at least primarily represent potentially regulated small entities, may also serve as SERs. Self-nominations must be received by February 16, 2022.


 
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Bergeson & Campbell, P.C.’s (B&C®) January 26, 2022, webinar “What to Expect in Chemicals in 2022” is now available for on-demand viewing at https://attendee.gotowebinar.com/recording/864194569862780944. During the 1-hour webinar, Lynn L. Bergeson, Managing Partner, B&C; Richard E. Engler, Ph.D., Director of Chemistry, B&C; and James V. Aidala, Senior Government Affairs Consultant, B&C offered their best informed judgment as to the trends and key developments chemical industry stakeholders should expect to see from the U.S. Environmental Protection Agency (EPA) in 2022.
 
Momentous changes initiated in 2021 will continue to influence policy development and rulemakings in 2022. For EPA’s Office of Chemical Safety and Pollution Prevention (OCSPP), emphasis on science integrity, reviewing decisions made by the Trump Administration in both the pesticide and industrial chemicals programs, meeting statutory deadlines looming over the work of both programs, and dealing with the constant problem of EPA-wide competing priorities will drive the OCSPP program budget and regulatory priorities. We encourage you to view the webinar and read our comprehensive Forecast for U.S. Federal and International Chemical Regulatory Policy 2022 to learn more about these competing priorities for which companies should now prepare.


 
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By Lynn L. Bergeson and Carla N. Hutton
 
On January 20, 2022, the U.S. Environmental Protection Agency (EPA) submitted a proposed rule to the Office of Management and Budget (OMB) concerning the procedures for submitting information subject to business confidentiality claims under the Toxic Substances Control Act (TSCA). According to an item in the fall 2021 Unified Agenda, EPA is considering proposing new and amended rules concerning the assertion and maintenance of claims of business confidentiality (i.e., confidential business information (CBI)) under TSCA. The 2016 Frank R. Lautenberg Chemical Safety for the 21st Century Act (Lautenberg Act) amendments included several new provisions concerning the assertion and EPA review and treatment of confidentiality claims. The Unified Agenda item states that EPA is considering procedures for submitting and supporting such claims in TSCA submissions, including substantiation requirements, exemptions, electronic reporting enhancements, and maintenance or withdrawal of confidentiality claims. EPA is also considering whether the proposed rule should also elaborate on its procedures for reviewing and communicating with TSCA submitters about confidentiality claims. EPA expects the proposed rule to include new provisions, as well as revisions to existing rules on asserting confidentiality claims to conform to the 2016 TSCA amendments.


 
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By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) announced on January 24, 2022, the automatic addition of four per- and polyfluoroalkyl substances (PFAS) to the Toxics Release Inventory (TRI) list. The Fiscal Year 2020 National Defense Authorization Act (NDAA) provides the framework for adding additional PFAS to the TRI each year. For TRI Reporting Year 2022 (reporting forms due by July 1, 2023), reporting is required for four additional PFAS. NDAA Section 7321(c) identifies certain regulatory activities that automatically add PFAS or classes of PFAS to the TRI beginning January 1 the following year, and EPA states that its development of a final toxicity value is one of the triggering actions. In April 2021, EPA issued a final toxicity value for perfluorobutane sulfonic acid (PFBS) and potassium perfluorobutane sulfonate; therefore, these substances have been added to TRI. According to EPA, PFBS-based compounds are replacement chemicals for perfluorooctane sulfonic acid (PFOS), a chemical that was voluntarily phased out by the primary U.S. manufacturer by 2002. PFBS has been identified in the environment and consumer products, including surface water, wastewater, drinking water, dust, carpeting and carpet cleaners, and floor wax.
 
EPA notes that it previously updated the Code of Federal Regulations with PFAS that were added to the TRI on January 1, 2021, pursuant to NDAA Section 7321(c) and their being regulated by an existing significant new use rule (SNUR) under the Toxic Substances Control Act (see 40 C.F.R. § 721.10536). EPA states that it has since determined that one additional PFAS, Chemical Abstracts Service Registry Number (CAS RN) 65104-45-2, is designated as “active” on the TSCA Inventory and is covered by the SNUR. Therefore, this substance has also been added to the TRI pursuant to the NDAA.
 
Additionally, under NDAA Section 7321(e), EPA must review confidential business information (CBI) claims before adding any PFAS to the TRI list whose identity is subject to a claim of protection from disclosure under 5 U.S.C. Section 552(a). EPA previously identified one PFAS, CAS RN 203743-03-7, for addition to the TRI list based on the NDAA’s provision to include certain PFAS upon the NDAA’s enactment (Section 7321(b)(1)); due to a CBI claim related to its identity, this PFAS was not included on the TRI list until EPA completed its review of the CBI claim. EPA included this PFAS in updates to the confidential status of chemicals on the TSCA Inventory published in October 2021, and thus added it to the TRI list due to the CBI declassification.
 
EPA states that as of January 1, 2022, facilities that are subject to reporting requirements for these chemicals should start tracking their activities involving these PFAS as required by Section 313 of the Emergency Planning and Community Right-to-Know Act (EPCRA). Reporting forms for these PFAS will be due to EPA by July 1, 2023, for calendar year 2022 data.


 
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By Lynn L. Bergeson and Carla N. Hutton
 
On January 21, 2022, the U.S. Environmental Protection Agency (EPA) announced a new effort under the Toxic Substances Control Act (TSCA) to streamline the review of new chemicals that could be used to displace current, higher greenhouse gas (GHG) emitting transportation fuels. The Office of Chemical Safety and Pollution Prevention’s (OCSPP) New Chemicals Division (NCD) has implemented a “robust, consistent, and efficient process to assess the risk and apply mitigation measures, as appropriate, for substitutes to petroleum-based fuels and fuel additives that use biobased or waste-derived sources to produce biofuels.” EPA states that this effort supports its goals under the Renewable Fuel Standard (RFS) program, as well as its 2021 Climate Adaptation Action Plan. According to the announcement, EPA has received over 30 biofuel premanufacture notices (PMN) “that collectively describe plans for close to 800 million gallons per year of production of advanced biofuels, that could contribute to annual volume mandates under the RFS program and help support the goals of energy security through increasing domestic production” within the United States.
 
The announcement includes:
 
New Chemicals Division Integrated Approach to Biofuels
 
Under this effort, NCD formed a dedicated team to collaborate on the review of PMNs for biobased or waste-derived feedstocks used to make transportation fuel substitutes with the goals to use the best available science while creating a consistent and efficient review process. EPA states that NCD developed a standardized process for the way biofuel PMNs are reviewed. For example, the same dedicated team will be conducting reviews for all biofuels PMNs, helping to ensure the assessments and determinations are consistent and aligned with requirements. Further, NCD will generate one report for biofuels PMNs that combines the six different risk assessments typically conducted for PMNs, helping to provide a clearer summary explanation of how EPA conducted its assessment and made its determination.
 
For risk management actions, NCD will apply appropriate mitigation measures to address any potential for unreasonable risk identified in an efficient and consistent manner within TSCA consent orders and significant new use rules (SNUR).
 
Outreach and Training
 
According to the announcement, OCSPP is launching outreach and training for interested stakeholders in the biofuels sector to review TSCA requirements, outline the streamlined approaches for risk assessments and risk management actions, and provide information on how to navigate the new chemicals PMN process.
 
OCSPP will hold a kick-off meeting on February 9, 2022, to provide an overview of this initiative and answer questions from stakeholders. Registration for the meeting is open.
 
Other planned outreach and training related to this biofuels initiative include webinars on:

  • TSCA requirements and the PMN process;
  • The TSCA Inventory, nomenclature, and Bona Fide process;
  • New chemicals risk assessments, including applications of the tools, models, and databases; and
  • New chemicals risk management actions, including TSCA Section 5 orders and SNURs.

EPA states that it may add additional outreach and training sessions, including training opportunities applicable to all new chemical submitters, based on stakeholder interest and feedback.


 
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By Lynn L. Bergeson and Carla N. Hutton

On January 21, 2022, the U.S. Environmental Protection Agency (EPA) announced that it will hold a virtual peer review meeting of the Science Advisory Committee on Chemicals (SACC) to consider and review the “Draft TSCA Screening Level Approach for Assessing Ambient Air and Water Exposures to Fenceline Communities Version 1.0.” 87 Fed. Reg. 3294. The meeting will be held March 15-17, 2022, and will be open to the public. Along with presenting the methodology, EPA will also present results of applying the screening methodology (case studies) to 1-bromopropane (1-BP) (air pathway), N-methylpyrrolidone (NMP) (water pathway), and methylene chloride (MC) (air and water pathway). In addition, EPA announced the availability of and solicited public comments on the draft approach, which will be presented as a screening level methodology for assessing potential air and water chemical exposures to fenceline communities. Comments are due February 22, 2022.

EPA's background documents, related supporting materials, and draft charge questions to the SACC are available in Docket ID EPA-HQ-OPPT-2021-0415 and on the SACC website. EPA will provide additional background documents (e.g., SACC members and consultants participating in this meeting and the meeting agenda) as the materials become available. Registration is required to receive the webcast meeting link and audio teleconference information. EPA states that it intends to announce registration instructions on the SACC website by early February 2022.

More information and a detailed commentary will be available in a forthcoming memorandum that will be posted on our website.


 
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By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) announced on January 13, 2022, that it is accepting public comments on candidates under consideration for selection as ad hoc peer reviewers assisting the Science Advisory Committee on Chemicals (SACC) with its review of the Draft Systematic Review Protocol Supporting TSCA Risk Evaluations for Chemical Substances. This comment period follows a previous 30-day call for nominations that ended on November 17, 2021. EPA will use comments on the potential candidates to assist it in selecting approximately six to eight ad hoc reviewers, depending on a balance of experience, to assist SACC with its review. Biographies of the candidates are available at regulations.gov. Comments are due January 28, 2022, to Docket ID EPA-HQ-OPPT-2021-0414.
 
As reported in our December 21, 2021, memorandum, the draft protocol incorporates changes to address recommendations from the National Academies of Sciences, Engineering, and Medicine, as well as comments received from SACC and the public. The SACC review of the protocol will take place during a public meeting April 19-21, 2022. According to EPA, this review “will provide a transparent process to ensure that the protocol follows sound science and incorporates independent scientific advice and recommendations.” EPA will announce registration instructions on the SACC website in early March.


 
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By Lynn L. Bergeson and Carla N. Hutton
 
On January 11, 2022, the White House Office of Science and Technology Policy (OSTP) released the report of its Scientific Integrity Task Force on protecting the integrity of government science. According to OSTP, 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.” The report finds that:

  • While violations of scientific integrity are small in number compared to the magnitude of the federal government’s scientific enterprise, they can significantly undermine federal decision-making and public trust in science;
  • Existing federal scientific integrity policies are responsive to previous Executive actions but need to be strengthened to deter better inappropriate influence in the conduct, management, communication, and use of science; and
  • Supporting scientific integrity requires attention to other policy areas, including greater transparency into research processes and outputs; clear guidelines for data and information that agencies release; and policies that promote safe, equitable workplaces free from harassment and discrimination.

OSTP notes that the Obama Administration identified six principles of scientific integrity in 2009. To not only restore, but to strengthen the integrity of federal science beyond the efforts of any previous Administration, the Task Force makes the following additional recommendations to guide policymaking and foster a culture of scientific integrity in federal agencies:

  • All federal agencies -- not just those that fund and conduct scientific research -- should develop, implement, and periodically update scientific integrity policies. Protecting scientific integrity is essential for any federal agency or entity that communicates or makes use of scientific and technical information in decision-making;
  • Scientific integrity policies should apply to all those in federal agencies who manage, communicate, or use science, not just to scientists and engineers who conduct research, and not just to career employees, but contractors and political appointees as well. All must be trained in scientific integrity and their roles in upholding it;
  • Scientific integrity policies should be modernized to address important, emergent issues. They must advance diversity, equity, inclusion, and accessibility; address new concerns arising from the use of emerging technologies such as artificial intelligence and machine learning; and apply to emerging modes of science, such as citizen science and community-engaged research with federal involvement;
  • There should be broader dissemination and adoption of good scientific integrity practices across the federal government, a task that could be facilitated by more formalized interagency collaboration; and
  • There should be widespread training for agency scientists so they can communicate scientific findings effectively to nonscientists in their agencies and to lay audiences, with the idea of helping to ensure that policies and actions are based on an accurate understanding of the science.

OSTP states that in the coming months, it will draw upon the findings of the Task Force to develop a plan for the regular assessment and iterative improvement of scientific integrity policies and practices. In addition, agency leadership, working closely with OSTP, will deploy this framework to ensure that their scientific integrity policies are informed by the Task Force report and adhere to scientific integrity principles.


 
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By Lynn L. Bergeson and Carla N. Hutton

Public Employees for Environmental Responsibility (PEER) announced on January 5, 2022, that it filed suit in the U.S. District Court for the District of Columbia to compel the U.S. Environmental Protection Agency (EPA) to disclose reports submitted pursuant to Section 8(e) of the Toxic Substances Control Act (TSCA). According to the complaint, PEER submitted a Freedom of Information Act (FOIA) request in November 2021 seeking records demonstrating how EPA deals with Section 8(e) reports. PEER states that it requested both Section 8(e) reports submitted to EPA and internal policies regarding publicly posting and using Section 8(e) reports. PEER notes that its FOIA request “built upon information reported in a November 2021 article in The Intercept noting that EPA had only posted one 8(e) report publicly since 2019 and describing disagreement over how the EPA processes 8(e) reports internally.”

In its announcement, PEER states that TSCA requires industry to notify EPA within 30 days when it obtains information that reasonably supports the conclusion that a chemical substance presents a substantial risk of injury to health or the environment. According to PEER, in early 2019, EPA stopped posting these industry reports in its public-facing database or on an easily searchable internal database. While industry submitted and EPA published more than 1,000 substantial risk reports from 2017 through 2018, PEER states that since 2019, EPA has posted only one to the public database. EPA scientists informed PEER that another approximately 1,240 reports have been received but sequestered.

PEER states that “[a]n EPA spokesperson told a news reporter that the person who had been responsible for posting these reports had retired in December 2018; and the agency lacked fundings to replace this single employee. However, at the same time, the agency finances an online tool enabling chemical companies to track their products through the approval process – internally called the ‘pizza tracker.’”

PEER asks the court to enter an order declaring that EPA wrongfully withheld requested documents and to issue a permanent injunction directing EPA to disclose all wrongfully withheld documents.


 
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