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.

By Lynn L. Bergeson and Carla N. Hutton
 
As reported in our March 25, 2022, blog item, the U.S. Environmental Protection Agency (EPA) announced on March 24, 2022, that it issued a second round of test orders under Section 4 of the Toxic Substances Control Act (TSCA) to obtain additional data on eight of the next 20 chemicals undergoing risk evaluation. In April 2022, EPA issued corrections to the following test orders:

  • 1,1,2-Trichloroethane: EPA amended Appendix D -- Order Recipient Selection. According to EPA, Appendix D referred to p-dichlorobenzene, although it should have referred to 1,1,2-trichloroethane. Appendix D only explains the process for identifying order recipients. EPA states that this correction does not change the obligations that apply to manufacturers and processors of 1,1,2-trichloroethane, pursuant to TSCA Section 4(a)(2). EPA identified the recipients of the order through those sources related to manufacturers and processors of 1,1,2-trichloroethane.
     
  • 1,2-Dichloroethane: EPA amended Appendix D -- Order Recipient Selection. According to EPA, Appendix D referred to p-dichlorobenzene, although it should have referred to 1,2-dichloroethane. Appendix D only explains the process for identifying order recipients. EPA states that the correction does not change the obligations that apply to manufacturers and processors of 1,2-dichloroethane, pursuant to TSCA Section 4(a)(2). EPA identified the recipients of the order through those sources related to manufacturers and processors of 1,2-dichloroethane.
     
  • 1,2-Dichloropropane: EPA amended Appendix D -- Order Recipient Selection. Appendix D referred to p-dichlorobenzene, although it should have referred to 1,2-dichloropropane. Appendix D only explains the process for identifying order recipients. The correction does not change the obligations that apply to manufacturers and processors of 1,2-dichloropropane, pursuant to TSCA Section 4(a)(2). EPA identified the recipients of the order through those sources related to manufacturers and processors of 1,2-dichloropropane.
     
  • 4,4'-(1-Methylethylidene)bis[2,6-dibromophenol] (TBBPA): EPA states that it amended the list of recipients to replace INEOS USA LLC with INEOS Enterprises US Holdco LLC. The effective date for INEOS Enterprises US Holdco LLC is five days after April 20, 2022, the date the memorandum was signed. The effective date for the companies listed in the original order issued on March 24, 2022, will remain March 29, 2022. EPA amended Appendix D -- Order Recipient Selection. Appendix D referred to p-dichlorobenzene, although it should have referred to TBBPA. Appendix D only explains the process for identifying order recipients. The correction does not change the obligations that apply to manufacturers and processors of TBBPA, pursuant to TSCA Section 4(a)(2). EPA identified the recipients of the order through those sources related to manufacturers and processors of TBBPA.
     
  • o-Dichlorobenzene: EPA amended Appendix D -- Order Recipient Selection. EPA states that Appendix D referred to p-dichlorobenzene, although it should have referred to o-dichlorobenzene. Appendix D only explains the process for identifying order recipients. The correction does not change the obligations that apply to manufacturers and processors of o-dichlorobenzene, pursuant to TSCA Section 4(a)(2). EPA identified the recipients of the order through those sources related to manufacturers and processors of o-dichlorobenzene.
     
  • Phosphoric acid, triphenyl ester (TPP): EPA amended the list of recipients to replace Axalta Coating Systems LLC with ChemSpec Ltd. The effective date for ChemSpec Ltd is five days after April 20, 2022, the date the memorandum was signed. The effective date for the companies listed in the original order issued on March 24, 2022, will remain as March 29, 2022. EPA also amended Appendix D -- Order Recipient Selection. According to EPA, Appendix D referred to p-dichlorobenzene, although it should have referred to TPP. Appendix D only explains the process for identifying order recipients. The correction does not change the obligations that apply to manufacturers and processors of TPP, pursuant to TSCA Section 4(a)(2). EPA identified the recipients of the order through those sources related to manufacturers and processors of TPP.
     
  • Trans-1,2-dichloroethylene: EPA amended the list of recipients to add the companies listed below. The effective date for the order for these companies will be five days after April 20, 2022, when the modification was signed. The effective date of the order for the companies listed in the March 24, 2022, order will also have the effective date of five days from April 20, 2022, when the modification was signed (i.e., both the companies listed below and the companies in the order signed on March 24, 2022, for trans-1,2-dichloroethylene will have an effective date five days after April 20, 2022, the date the memorandum was signed):
    • Chemical Compounding Co;
    • Dow Inc;
    • MicroCare LLC;
    • Occidental Chemical Holding Corp;
    • Olin Corp; and
    • Versum Materials Inc.

EPA amended Appendix D -- Order Recipient Selection. Appendix D referred to p-dichlorobenzene, although it should have referred to trans-1,2-dichloroethylene. Appendix D only explains the process for identifying order recipients. EPA states that the correction does not change the obligations that apply to manufacturers and processors of trans-1,2- dichloroethylene, pursuant to TSCA Section 4(a)(2). EPA identified the recipients of the order through those sources related to manufacturers and processors of trans-1,2-dichloroethylene.


 

By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) announced on May 19, 2022, the availability of the meeting minutes and final report for the March 15-17, 2022, Science Advisory Committee on Chemicals (SACC) virtual meeting regarding EPA’s proposed Screening Level Approach for Assessing Ambient Air and Water Exposures to Fenceline Communities Version 1.0 under the Toxic Substances Control Act (TSCA). According to the meeting minutes and final report, SACC “agreed that the methodological document was well organized and generally well written.” SACC states that it “had difficulty reproducing results that were relevant to understanding and reviewing the document and indicated multiple limitations and uncertainties,” however. SACC suggested the methodology could only be used as part of a tiered approach to evaluate risk to fenceline communities and should not be used to evaluate risks in isolation. The screening level approach may be protective for the specific exposure pathways included, but it may not be protective overall because potential key exposure pathways are excluded and because it does not consider cumulative exposures, multiple source exposures, aggregate exposures, and double/aggregate and occupational exposures from workers living near and working at the facilities. Some SACC members also suggested that additional risk factors, such as stress, poverty, cultural practices, and diet, should be considered for a comprehensive assessment.
 
The meeting minutes and final report states that the accuracy and/or completeness of the data used to develop the screening analysis were not adequately supported in the document, and SACC decided it did not defensibly represent actual exposure of fenceline communities. Overall, SACC indicated the basis for several model inputs was insufficiently transparent and that, in particular, daily life activities of all communities disproportionately impacted by chemical exposures was missing in this current version. SACC recommended the term “fenceline” be refined to include the characteristics, behaviors, and realities of communities exposed through means that are not dependent on being within a limited radius from a chemical facility. SACC agreed that Version 1 of the screening tool for fenceline communities “is currently not adequate for evaluating potential exposures relevant to tribes, indigenous populations, subsistence lifestyles, cultural practices, or other unique circumstances. The pathways by which people in unique communities are exposed to chemicals of the contaminated areas are much broader than those represented in the current defining criteria of ‘Fenceline Communities.’” To make the tool applicable for any unique community, the meeting minutes and final report state that additional exposure scenarios and relevant data must be applied.
 
SACC recommended that knowledgeable community representatives “be intrinsically involved for perspective on how such information is applied in a screening endeavor, as well as the relevance and pedigree of values used to inform exposure algorithms, and relevance of default data and assumptions.” Complementary to this process is the need for enhanced and meaningful outreach to “fenceline communities” and all parties interested in these screens. SACC offered specific commentary and suggestions, along with a collection of references. A meeting transcript is available.


 

By Lynn L. Bergeson and Carla N. Hutton

On May 12, 2022, the U.S. Environmental Protection Agency (EPA) announced the publication of information collected during the 2020 Chemical Data Reporting (CDR) cycle to increase public awareness of chemicals being manufactured in communities and to enable citizen and stakeholder access and use of the reported information. The CDR rule requires manufacturers (including importers) of certain chemicals listed on the Toxic Substances Control Act (TSCA) Inventory to report data to EPA every four years. Manufacturers (including importers) are required to report if they meet certain production volume thresholds, generally 25,000 pounds or more of a chemical at any single site. CDR is the most comprehensive source of basic exposure-related information on chemicals in U.S. commerce. EPA states that the collection of CDR information “is essential to meeting the agency’s information needs, especially for prioritization, risk evaluation, and risk management of chemicals under TSCA.” According to EPA, CDR information enables it to develop an understanding of the types, amount, end uses, and possible human exposure to inform its identification, evaluation, and management of risks to human health and environmental risks.

The 2020 CDR information primarily covers manufacture, processing, and use activities for calendar year 2019. The data released include company and site information, manufacturing (including import) information, production volume, and processing and use data, as well as information on chemicals not included in previous releases. According to EPA, this includes chemicals that lost their confidential status on the TSCA Inventory because one or more manufacturers reported the chemical identities as non-confidential during the 2012, 2016, and/or 2020 CDR reporting periods. Therefore, the 2020 CDR database will include information related to those chemical identities that could not be revealed publicly in previous publications of CDR data.

The 2020 CDR data are available in downloadable files on EPA’s CDR web pages. EPA states that it will also soon make the data available in ChemView. Resources about using the CDR database and interpreting the CDR data are also available from EPA’s CDR website.

Tags: CDR

 

By Lynn L. Bergeson and Carla N. Hutton

On May 12, 2022, the U.S. Environmental Protection Agency (EPA) published a proposed rule relating to the assertion and maintenance of confidential business information (CBI) claims under the Toxic Substances Control Act (TSCA). 87 Fed. Reg. 29078. EPA states in its May 12, 2022, press release that the proposed rule includes new and amended requirements that, if made final, would increase transparency, modernize reporting and review procedures, and ensure consistency with the 2016 amendments to TSCA. In addition to providing increased clarity for TSCA submitters, EPA expects the changes to allow it to review and make determinations on CBI claims more efficiently, meeting the statutory review deadline in TSCA and more promptly making required notifications to submitters of claims. Comments are due July 11, 2022.

The proposed rule includes:

Provisions Intended to Increase Transparency

  • Changes intended to ensure that the existence and scope of a CBI claim is clear and limited to information the submitter views as confidential;
  • A provision to address inappropriate or overly broad CBI claims in public copies of TSCA submissions, especially health and safety related information, that specifies a process for the submitter to correct promptly those issues early in the CBI review and that EPA would promptly deny any remaining inappropriate claims. These changes are expected to remove ambiguity about the scope or validity of claims, permitting more rapid review of valid CBI claims and public access to non-CBI information.
  • Expanded requirements for electronic reporting and uniform requirements to provide publicly releasable copies of certain documents, such as scientific studies, both of which would make more data available to the public more quickly.
  • Requirements for electronic communication and maintaining current and accurate contact information to ensure more prompt delivery of required notices to submitters of CBI claims, thereby permitting EPA to make information for which CBI claims have been withdrawn, denied, or expired available to the public more quickly.

Provisions Intended to Modernize CBI Procedures and Ensure Consistency with Amended TSCA

  • Clear and uniform guidance on requirements for assertion and maintenance of CBI claims, including a standard set of substantiation questions used to support a CBI claim.
  • Requirements for electronic reporting of virtually all CBI claims, with enhancements to reporting tools that will prevent or mitigate common procedural errors EPA has observed to:
    • Ensure better procedural requirements for asserting a claim are met (with built-in certification and validation features for substantiation and generic names);
    • Articulate better and more narrowly the confidential information that is being claimed; and
    • Clarify CBI provisions that apply to individual data elements, such as where CBI claims are not permitted or where upfront CBI substantiation is not required to support a claim.
  • Establishment of a new section of the TSCA regulations to consolidate and standardize how TSCA CBI claims must be asserted and substantiated.
  • Requirements that health and safety information be submitted using an appropriate Organization for Economic Cooperation and Development (OECD) Harmonized Template (when available), a format that will allow data to be more readily used and shared within EPA while allowing submitters to indicate CBI claims more clearly for EPA consideration.

EPA seeks public comment on all aspects of the proposed rule and the Economic Analysis prepared in support of it. In addition to specific requests for comment included throughout the proposed rule, EPA invites specific comment on:

  • EPA’s interpretation of the coverage of TSCA Section 14(a) (proposed Section 703.1) and how this may impact submitters of information to EPA under other statutes, such as the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). EPA states that it is particularly interested in comments on the treatment of FIFRA studies on inert ingredients under TSCA Section 14(b)(2).
  • The applicability of the proposed new or revised requirements to submissions received before the effective date of the subsequent final rule. Specifically, EPA requests comment on whether each proposed new or revised requirement should apply only to submissions received on or after the effective date of the final rule; to all submissions received on or after the effective date of the Frank R. Lautenberg Chemical Safety for the 21st Century Act (Lautenberg Act) amendments; or to all submissions regardless of submission date.
  • The proposed substantiation questions (proposed Section 703.5(b)), especially the proposal to omit a trade secrets-specific question; on how the patents question might be modified to elicit more pertinent information; and comment on the alternative substantial competitive harm question.
  • The proposed list of information that might be included with health and safety information, but that might be permissible to withhold as confidential (proposed Section 703.5(b)(6)). EPA is also interested in comment on alternatives to the proposal that might better ensure that health and safety information is not inappropriately treated as confidential.
  • The proposed approach to CBI claim deficiencies (proposed Section 703.5(e)) and on alternative approaches.
  • Whether submitting templated data should be required (proposed Section 703.5(g)).
  • The option of requiring TSCA submitters to update their original submission to reflect CBI claims that have been withdrawn or denied (proposed Section 703.5(j)).
  • Selection of the representative subset, including possible alternative representative selection methods (proposed Section 703.7).
  • Whether bona fide or pre-notice inquiries or correspondence should be considered part of a representative subset of TSCA submissions (proposed Section 703.7).
  • On the proposed approach to determining when a TSCA Section 14(g) CBI review period begins and how amendments to the submission are included in the review (proposed Section 703.7).
  • The proposed and alternative possible approaches to efficiently developing an acceptable generic name for purposes of listing on the TSCA Inventory, as described in proposed Sections 720.102 and 725.190.
  • On how to incorporate whether a substance may be readily reverse engineered into EPA’s substantive review criteria in proposed Section 703.7(f).

Our forthcoming memoranda will include a detailed summary of the proposed rule and an insightful commentary.

Tags: CBI

 

By Lynn L. Bergeson and Carla N. Hutton
 
On May 12, 2022, the White House Office of Science and Technology Policy’s (OSTP) National Science and Technology Council’s (NSTC) Strategy Team on Sustainable Chemistry will host the second webinar in a series regarding the team’s tasks of defining, assessing, and preparing a strategic plan in the area of sustainable chemistry in response to direction in the National Defense Authorization Act of 2020. The presenters in the webinar will discuss the science, technology, and innovation needs of the chemical industries, including carbon capture, sustainable process design, and chemical separation technologies. Speakers will include:

  • Dionisios (Dion) G. Vlachos, University of Delaware;
  • Joan F. Brennecke, University of Texas at Austin; and
  • Jennifer Wilcox, Principal Deputy Assistant Secretary in the Office of Fossil Energy and Carbon Management at the U.S. Department of Energy.

Registration is now open.

Tags: OSTP, NSTC, Webinar,

 

By Lynn L. Bergeson and Carla N. Hutton

On May 5, 2022, the U.S. Department of Justice (DOJ) and the U.S. Environmental Protection Agency (EPA) announced a series of actions intended to secure environmental justice for all Americans. In addition to launching a new Office of Environmental Justice within DOJ, Attorney General Garland also announced a new comprehensive environmental justice enforcement strategy to guide DOJ’s work and an interim final rule that will restore the use of supplemental environmental projects (SEP) in appropriate circumstances.

Consistent with President Biden’s Executive Order on Tackling the Climate Crisis at Home and Abroad, Associate Attorney General Vanita Gupta issued a comprehensive environmental justice enforcement strategy to guide DOJ’s litigators, investigators, and U.S. Attorneys’ Offices nationwide to advance the cause of environmental justice through the enforcement of federal laws. Developed by DOJ’s Environment and Natural Resources Division (ENRD) in partnership with EPA, the strategy will ensure that the entire DOJ “is using all available legal tools to promote environmental justice.”

DOJ also launched its first-ever Office of Environmental Justice (OEJ) within ENRD. According to DOJ, this new office will be a critical resource as DOJ implements the new comprehensive enforcement strategy. Cynthia Ferguson, an experienced ENRD attorney with more than a decade working on environmental justice issues, will be Acting Director.

Finally, DOJ announced an interim final rule, scheduled to be published in the May 10, 2022, Federal Register, that will restore the use of SEPs in appropriate circumstances and subject to guidelines and limitations set forth in a separate memorandum issued by the Attorney General. In its May 5, 2022, press release, EPA states that SEPs “are local projects that defendants can agree to undertake as part of an enforcement case settlement to help rectify environmental violations. SEPs help to fulfill the goals of the underlying statutes being enforced and can provide important environmental and public health benefits to communities that have been harmed by environmental violations.” SEPs are considered in accordance with EPA’s SEP Policy, which ensures there is a sufficient connection to the violation. The SEP Policy provides for consideration of a defendant’s willingness to implement a SEP as part of EPA’s decision about whether, and on what terms, to settle an enforcement matter, just as EPA has discretion to consider, as appropriate, a defendant’s good faith and cooperation when deciding on a penalty and other terms of a settlement. Publication of the interim final rule in the Federal Register will begin a 60-day comment period.


 

By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) announced on February 25, 2022, the proposed Toxic Substances Control Act (TSCA) New Chemicals Collaborative Research Program. 87 Fed. Reg. 10784. On March 10, 2022, EPA posted the draft document entitled “Modernizing the Process and Bringing Innovative Science to Evaluate New Chemicals Under TSCA.” The Office of Chemical Safety and Pollution Prevention (OCSPP) proposes to develop and implement a multi-year collaborative research program focused on approaches for performing risk assessments on new chemical substances under TSCA. On April 26, 2022, the TSCA New Chemicals Coalition (NCC) submitted comments to EPA expressing strong support for EPA’s proposed update to its approach to review and evaluate new chemicals under TSCA Section 5:

  • Research Area 1 -- Update and Refine Chemical Categories: The NCC suggests that EPA develop an Integrated Approach to Testing and Assessment (IATA) for each category, and that the IATA include New Approach Methodologies (NAM) both to set boundaries and to provide a tiered approach for testing;
     
  • Research Area 2 -- Develop and Expand Databases Containing TSCA Chemical Information: The NCC suggests that EPA include robust chemical structure information that is searchable by substructure and Markush representations, as appropriate, in the database. The NCC agrees that using IUCLID and the Organization for Economic Cooperation and Development (OECD) harmonized templates would be an efficient way to curate the data and would contribute to interoperability with other data systems (especially as data are transported from other regions that rely upon IUCLID);
     
  • Research Area 3 -- Develop and Refine Quantitative Structure-Activity Relationship and Predictive Models: The NCC suggests that EPA evaluate whether other existing models may serve EPA’s needs. The NCC also suggests that EPA update E-FAST with additional site-specific stream flows;
     
  • Research Area 4 -- Explore New Ways to Integrate and Apply NAMs: The NCC strongly supports expanding the use of NAMs in the assessment of new chemicals. The NCC also strongly suggests that EPA develop and enforce internal policies about in vivo testing of irritating and corrosive substances;
     
  • Research Area 5 -- Develop a TSCA New Chemicals Decision Support Tool: The NCC supports developing such a decision support tool, but refers EPA to this function within IUCLID. The NCC supports improved transparency on risk assessments and suggests that EPA separate boilerplate explanations of hazard, exposure, and risk from the unique assessment results.

More information on EPA’s draft document is available in our March 14, 2022, memorandum.


 

Wednesday, May 18, 2022
12:00 p.m. - 1:00 p.m. (EDT)

Register Today

A circular economy requires new thinking about what products we make, from which materials we make them, and where products go at the end of their useful life. An important but often overlooked aspect of new product development is an understanding of the consequences of the product’s chemical composition and the end-of-life implications of the decisions made at the front end of the process. Working within this framework plays a critical role in building a resilient, dependable, and sustainable system that fosters innovation to develop a circular economy. Register now to join Lynn L. Bergeson, Richard E. Engler, Ph.D., Kate Sellers, and Mathy Stanislaus, as Bergeson & Campbell, P.C. (B&C®) presents “Domestic Chemical Regulation and Achieving Circularity.”

Topics Covered:

  • Achieving sustainability and the promise of the circular economy
  • Defining sustainable chemistry under the Sustainable Chemistry Research and Development Act
  • Federal policy and Toxic Substances Control Act (TSCA) regulatory shifts intended to support sustainability and circularity
  • Transitioning chemicals from research and development (R&D) platforms into the market
  • Changes to TSCA and the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) that affect chemical innovation

Speakers Include:

Lynn L. Bergeson, Managing Partner, B&C, has earned an international reputation for her deep and expansive understanding of how regulatory programs pertain to industrial biotechnology, synthetic biology, and other emerging transformative technologies. She counsels corporations, trade associations, and business consortia on a wide range of issues pertaining to chemical hazard, exposure and risk assessment, risk communication, minimizing legal liability, and evolving regulatory and policy matters.

Richard E. Engler, Ph.D., Director of Chemistry, B&C, is a 17-year veteran of the U.S. Environmental Protection Agency (EPA) and is one of the most widely recognized experts in the field of green chemistry, having served as senior staff scientist in EPA’s Office of Pollution Prevention and Toxics (OPPT) and leader of EPA’s Green Chemistry Program. His expansive understanding of the specific challenges and opportunities that TSCA presents for green and sustainable chemistry is a powerful asset for clients as they develop and commercialize novel chemistries.

Kate Sellers, Technical Fellow at ERM, leads a multi-disciplinary team of professionals dedicated to helping companies recognize the business value of product stewardship. Over the past year, Kate has seen an uptick in several product sustainability trends, including implementation of the TSCA life-cycle assessment, circular economy programs, and sustainability initiatives. In addition to her consulting work, Kate teaches “Product Stewardship and Chemical Sustainability” at Harvard University

Mathy Stanislaus, was recently appointed as Vice Provost and Executive Director of Drexel University’s Environmental Collaboratory, bringing interdisciplinary expertise in environmental sciences, engineering, law, health, business, economics, policy, and humanities to co-design transformative environmental solutions. Stanislaus joined Drexel from the Global Battery Alliance (GBA), a multi-stakeholder initiative established at the World Economic Forum (WEF), where he served as its first interim director and policy director with a focus on establishing a global transparent data authentication system to scale up electric mobility and clean energy. He also led the establishment of the Platform for Accelerating Circular Economy at WEF. Mathy served for eight years as the Senate-confirmed Assistant Administrator for EPA’s Office of Land & Emergency Management for the Obama Administration, leading programs to revitalize communities through the cleanup and redevelopment of contaminated sites, hazardous and solid waste materials management, chemical plant safety, and oil spill prevention and emergency response. During this Administration, he led the establishment of the G7 Alliance for Resource Efficiency that focused on the opportunities in the supply chain to drive circularity and de-carbonization.

Register Now


 

By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) held a virtual public meeting on April 20-21, 2022, to provide an overview of the Toxic Substances Control Act (TSCA) New Chemicals Collaborative Research Program and give stakeholders an opportunity to provide input. As described in EPA’s draft document entitled “Modernizing the Process and Bringing Innovative Science to Evaluate New Chemicals Under TSCA,” the Office of Chemical Safety and Pollution Prevention (OCSPP) proposes to develop and implement a multi-year collaborative research program focused on approaches for performing risk assessments on new chemical substances under TSCA. EPA has posted the following presentations from the April 20-21, 2022, meeting:

More information on the meeting is available in our April 22, 2022, memorandum, and more information on EPA’s draft document is available in our March 14, 2022, memorandum. Written comments on the draft document are due May 10, 2022.


 

On May 4-5, 2022, the U.S. Environmental Protection Agency (EPA) Board of Scientific Counselors (BOSC) Executive Committee will meet to review the Office of Research and Development’s (ORD) six Strategic Research Action Plans (StRAP) for fiscal years (FY) 2023-2026. The meetings are open to the public. 87 Fed. Reg. 23861. BOSC will consider comments on the draft StRAPs that are submitted by May 3, 2022. Requests for the draft agenda or making a presentation at the meeting will be accepted until May 3, 2022. The meeting is open to the public. Registration is required.

The draft StRAPs outline the leading-edge research strategies necessary to provide the scientific foundation for EPA to execute its mandate to protect human health and the environment. ORD organized the StRAPs around each of its six National Research Programs and developed them through a series of listening sessions, workshops, and consultations with EPA partners; state, tribal, and local partners; and community groups. EPA plans to release the final StRAPs later this year. The draft StRAPs for ORD’s six National Research Programs include:

According to the draft CSS StRAP, “[a] key issue with current chemical safety assessment is that traditional approaches have been unable to keep pace with innovations in chemical design, synthesis, and use.” The draft StRAP states that CSS will continue to:

  • Develop the science needed to reduce, refine, and replace vertebrate animal testing consistent with EPA policies;
  • Accelerate the pace of chemical assessment to enable its partners to make informed and timely decisions concerning the potential impacts of environmental chemicals on human health and the environment; and
  • Provide leadership to transform chemical testing, screening, prioritization, and risk assessment practices.

While continuing its core research activities, ORD envisions that CSS will further incorporate cross-cutting research priorities. To be effective over the course of the StRAP, CSS will not only develop robust scientific data and innovative tools, but also interpretative frameworks.

According to the draft HERA StRAP, HERA “develops a portfolio of fit-for-purpose human health or environmental assessment products and assessment-related research to meet EPA’s wide-ranging statutory and regulatory needs.” HERA identifies, evaluates, and integrates existing and emerging information from diverse scientific disciplines to characterize human or environmental hazards. The draft StRAP states that HERA advances the science and practice of assessment through methods development, case studies, models, and tools that are tethered to assessment needs.

HERA “will continue as a leader in innovating and applying systematic review methods, including evidence integration and mapping.” According to the draft StRAP, areas of new or increasing emphasis will incorporate research relevant to children’s environmental health, equity and environmental justice, climate change, and cumulative risk. The draft StRAP states that HERA’s strategic direction “culminates in a program structured to facilitate efficient construction and production of high-quality, transparent, state-of-the-science assessment research that maximizes resources to address priority statutory, regulatory, and programmatic needs.”

Tags: ACE, BOSC, CSS, HERA, HS, ORD, SHC, SSWR, StRAP

 
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