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

On October 17, 2019, the House Committee on Science, Space, and Technology unanimously approved the Sustainable Chemistry Research and Development Act (H.R. 2051), a companion bill to legislation introduced in the Senate by Senators Chris Coons (D-DE), Susan Collins (R-ME), Amy Klobuchar (D-MN), and Shelley Moore Capito (R-WV).  Representative Dan Lipinski (D-IL) introduced the House bill on April 3, 2019.  It is co-sponsored by Representative John Moolenaar (R-MI).  The bill is intended to improve coordination of federal activities, including research and development of more sustainable chemicals, processes, and systems by establishing a coordinating entity under the National Science and Technology Council within the Office of Science and Technology Policy.  The legislation would allow the agencies involved in this entity to work, in consultation with qualified stakeholders, to assess the state of sustainable chemistry in the United States and encourage the validation of tools for assessment of sustainable chemistry processes or products.  The agencies would include the U.S. Environmental Protection Agency, the National Institute of Standards and Technology, the National Science Foundation, the Department of Energy, the Department of Agriculture, the Department of Defense, the National Institutes of Health, the Centers for Disease Control and Prevention, the Food and Drug Administration, and other related federal agencies, as appropriate.  The bill also supports improved education and training in sustainable chemistry.


 
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By Lynn L. Bergeson and Carla N. Hutton
 
Alexandra Dapolito Dunn, Assistant Administrator for the U.S. Environmental Protection Agency’s (EPA) Office of Chemical Safety and Pollution Prevention (OCSPP) stated on October 11, 2019, that EPA will provide more time for public comment on its draft risk evaluations before the Toxic Substances Control Act (TSCA) Science Advisory Committee on Chemicals (SACC) meets to peer review the draft documents.  According to Dunn, the new schedule will include a comment period of at least 30 days before SACC meets.  EPA plans to complete ten chemical risk evaluations by June 22, 2020.  To date, EPA has released four draft chemical risk evaluations, and SACC has peer reviewed them.  For the remaining six chemicals, EPA intends to release four of the draft risk evaluations for public comment by the end of 2019 and the other two in January 2020.  SACC will peer review two of the draft risk evaluations in 2019 and the remaining four in 2020.  Dunn stated that EPA will meet the Lautenberg Act’s deadline to release all ten risk evaluations by June 2020.


 
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By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) Office of Inspector General (OIG) announced on September 23, 2019, that it plans to begin an evaluation of EPA’s implementation of the 2009 Toxic Substances Control Act (TSCA) premanufacture notice (PMN) consent order with DuPont [Chemours].  According to OIG, its objective is to determine what actions EPA took to verify compliance with the requirements of the consent order to prevent release of the chemical GenX into the Cape Fear River basin.  OIG states that it plans to conduct work in headquarters within the Office of Enforcement and Compliance Assurance and the Office of Chemical Safety and Pollution Prevention, as well as Region 4.  The anticipated benefits of the project are to improve controls over TSCA PMN consent orders.

Tags: PMN, DuPont, Chemours,

 
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By Lynn L. Bergeson and Carla N. Hutton
 
On September 23, 2019, the U.S. Environmental Protection Agency (EPA) Office of Inspector General (OIG) announced that it plans to begin fieldwork on EPA’s Safer Choice program.  According to OIG, its objectives are to identify and assess the controls that EPA has in place to verify that the Safer Choice program meets its goals and achieves quality standards through its product qualification, renewal, and required audit process.  OIG states that Safer Choice “is a voluntary labeling program that helps consumers and commercial buyers find chemical-based products that are safer for human health and the environment.”  OIG plans to conduct work at headquarters and at various third-party assessor and auditor locations.  It will use applicable generally accepted government auditing standards in conducting its audit.  The anticipated benefits of the audit “are reducing the use of chemicals of concern and empowering consumers to protect their health.”

Tags: Safer Choice,

 
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By Lynn L. Bergeson and Carla N. Hutton
 
On September 30, 2019, the U.S. Environmental Protection Agency (EPA) announced the availability of the meeting minutes and final report for the June 18-21, 2019, meeting of the Toxic Substances Control Act (TSCA) Science Advisory Committee on Chemicals (SACC) on the draft risk evaluation for Pigment Violet 29 (PV29).  SACC’s report addresses the scientific issues being considered by EPA regarding the peer review for the draft risk evaluation.  As reported in our November 16, 2018, memorandum, “EPA Publishes First Draft TSCA Chemical Risk Evaluation,” the draft risk evaluation states that EPA considered all reasonably available data for PV29 to make a determination of whether the risk it poses is unreasonable.  EPA “concludes that C.I. Pigment Violet 29 does not present an unreasonable risk of injury to human health or the environment, without considering costs or other non-risk factors, including no unreasonable risk to potentially exposed and susceptible subpopulations identified as relevant, under the conditions of use.”  EPA requested SACC to provide advice and recommendations on questions concerning:

  • The overall content, organization, and presentation of the draft risk evaluation;
  • Systematic review;
  • Physical chemical properties/environmental fate;
  • Exposure and releases;
  • Environmental effects;
  • Human health;
  • Risk characterization/risk determination; and
  • Supplemental analysis.

The report notes that this first SACC peer review is the first time the TSCA program is making non-TSCA confidential business information (CBI) available to peer reviewers.  According to the report, EPA requested comment on the process, integration, and clarity related to the use of the CBI that was provided.  EPA provided SACC members TSCA CBI training, and they were permitted to review the full studies as part of their peer review.  The report states that upon a comparison of the full (unredacted) studies with the redacted studies, SACC reached consensus that the nature of the redactions do not materially impact the draft risk characterization.  SACC agreed that the summary statistics provided in the unredacted version of the reproduction/development study were consistent with the animal data in the redacted version of the study.  SACC made recommendations to EPA about how to process CBI information for use by SACC and the public for future assessments.


 
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By Lynn L. Bergeson, Charles M. Auer, and Carla N. Hutton
 
On September 25, 2019, the U.S. Environmental Protection Agency (EPA) submitted a proposed significant new use rule (SNUR) on long-chain perfluoroalkyl carboxylate (LCPFAC) and perfluoroalkyl sulfonate (PFAS) chemical substances to the Office of Management and Budget (OMB) for review.  The item on the rulemaking in EPA’s Spring 2019 Regulatory Agenda states that in 2015, EPA proposed amending the SNURs under Section 5(a)(2) of the Toxic Substances Control Act (TSCA) for LCPFAC chemical substances and for perfluorooctanoic acid (PFOA) or its salts.  80 Fed. Reg. 2885 (Jan. 21, 2015).  Specifically, EPA proposed to amend the SNUR for LCPFAC chemical substances by designating as a significant new use manufacturing (including importing) or processing of an identified subset of LCPFAC chemical substances for any use that will not be ongoing after December 31, 2015, and all other LCPFAC chemical substances for which there are currently no ongoing uses.  EPA also proposed to make inapplicable the exemption for persons who import LCPFAC chemical substances as part of articles.  In addition, EPA proposed to amend the SNUR for PFAS chemical substances that would make inapplicable the exemption for persons who import PFAS chemical substances as part of carpets.  Persons subject to these SNURs would be required to notify EPA at least 90 days before commencing such manufacture or processing.  The required notifications would initiate EPA’s evaluation of the intended use within the applicable review period.  Manufacture and processing for the significant new use would be unable to commence until EPA has conducted a review of the notice, made an appropriate determination on the notice, and taken such actions as are required in association with that determination.
 
EPA states that it is developing a supplemental proposal for the LCPFAC SNUR amendments to make inapplicable the exemption for persons who import a subset of LCPFAC chemical substances as part of certain articles.  According to EPA, this supplemental proposal is necessary to be responsive to the article consideration provision in TSCA Section 5(a)(5) that was added with the 2016 amendments to TSCA.  Under the provision, articles can be subject to notification requirements as a significant new use provided that EPA makes an affirmative finding in a rule that the reasonable potential for exposure to a chemical from an article or category of articles justifies notification.  Insofar as this new provision has not been used previously for chemical substances with a history of prior import in articles, EPA’s approach to and its arguments in making this required affirmative finding will be important for all stakeholders to consider carefully.


 
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By Lynn L. Bergeson and Carla N. Hutton
 
On September 25, 2019, the U.S. Environmental Protection Agency (EPA) recognized 14 Safer Choice Partner of the Year award winners for outstanding achievement in 2018 for the design, manufacture, selection, and use of products with safer chemicals for use in households and facilities nationwide.  The Safer Choice program partners with businesses and others to help consumers and commercial buyers identify products with safer chemical ingredients, without sacrificing quality or performance.  According to EPA’s press release, the 2019 Partner of the Year award winners represent businesses -- including woman-owned and small- and medium-sized -- local government, and associations.  The following organizations from seven EPA regions are being awarded this year:


 
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By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) announced on September 20, 2019, that it will extend the public comment period for its proposed rule intended to reduce exposures to certain chemicals that are persistent, bioaccumulative, and toxic (PBT).  84 Fed. Reg. 36728.  EPA identified five chemicals pursuant to Section 6(h) of the Toxic Substances Control Act (TSCA):  decabromodiphenyl ether (DecaBDE); phenol, isopropylated phosphate (3:1) (PIP (3:1)), also known as tris(4-isopropylphenyl) phosphate; 2,4,6-tris(tert-butyl)phenol (2,4,6-TTBP); hexachlorobutadiene (HCBD); and pentachlorothiophenol (PCTP).  The proposed rule would restrict or prohibit manufacture (including import), processing, and distribution in commerce for many uses of all of the chemicals except HCBD, for which EPA is proposing no regulatory action.  For the other four chemicals, the proposed rule includes recordkeeping requirements, as well as additional downstream notification requirements for PIP (3:1).  Comments are now due October 28, 2019.  EPA is required to issue a final rule by December 2020.  Our June 24, 2019, memorandum, “EPA Publishes Proposed PBT Chemicals Rule under TSCA,” provides a detailed review and analysis.

Tags: PBT, Section 6,

 
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By Lynn L. Bergeson, Richard E. Engler, Ph.D., and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) announced on September 19, 2019, that it posted the first public Toxic Substances Control Act (TSCA) Inventory to include unique identifier (UID) information.  EPA states that the UID is a numerical identifier assigned to a chemical substance when EPA approves a confidential business information (CBI) claim for specific chemical identity.  When EPA approves such a claim, it assigns a UID to that chemical identity; applies the UID to other information or submissions concerning the same substance; and ensures that any non-confidential information received by EPA identifies the chemical substance using the UID while the specific chemical identity of the chemical substance is protected from disclosure.
 
EPA notes that this is the first time that the public version of the TSCA Inventory includes both a field containing a UID for those chemical substances with approved confidentiality claims for specific chemical identity and a field containing the ten-year expiration date from the assertion of such approved claims.  EPA states that the UIDs provide the public with a way to connect the specific chemical identity previously listed on the confidential portion of the TSCA Inventory with other relevant information in EPA’s holdings. 

Commentary

EPA’s goal is to publish an up-to-date version of the TSCA Inventory about every six months.  With the version published on September 19, 2019, EPA has taken another positive step in implementing its obligations under TSCA.  The Inventory now includes two new fields: UI (for the unique identifier or UID) and EX (indicating the expiration date of the CBI claim).  EPA continues to work through CBI identities, so only a few of the CBI substances have a UID.  We expect that EPA will begin to assign UIDs to CBI substances that are newly added to the Inventory (e.g., through a Notice of Commencement submitted going forward).  We also expect that EPA will assign UIDs to substances that were claimed as CBI on a Form A as EPA works through reviewing the almost 8,000 substances listed as active on the confidential portion of the Inventory.  A more detailed commentary is available in our September 20, 2019, memorandum, “EPA Includes Unique Identifier Information on Updated TSCA Inventory.”

Tags: Inventory, UID, CBI,

 
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By Lynn L. Bergeson and Carla N. Hutton
 
The Environmental Defense Fund (EDF) published a September 16, 2019, blog item entitled “EPA’s latest move to deflect criticism of its TSCA risk evaluations: Muzzle its science advisors.”  EDF notes that it has opposed a number of recent decisions made by the U.S. Environmental Protection Agency (EPA) “that aim to limit the risks it finds when evaluating the safety of chemicals under the Toxic Substances Control Act (TSCA),” including:

  • Excluding from its analysis known human and environmental exposures to a chemical, based on the assumption that those exposures are adequately managed by other statutes;
     
  • Claiming without support that workers are protected by assuming universal and universally effective use of personal protective equipment throughout chemical supply chains and the adequacy of the Occupational Safety and Health Administration (OSHA) regulations that either do not apply or are out of date;
     
  • Arbitrarily loosening EPA’s longstanding risk standards governing when cancer incidences are deemed unacceptably high; and
     
  • Choosing not to exercise its enhanced authorities under TSCA to require submission of robust information on chemicals’ hazard and exposures, instead making “questionable assumptions and relying on voluntarily submitted industry data that are unrepresentative or of poor or indeterminate quality.”

EDF states that through these decisions, EPA increases the likelihood that it will either not find unreasonable risk and thereby avoid regulating the chemical, or find risks that are low enough that it can impose few restrictions.  According to EDF, in response to each of these decisions, EPA received critical comments on its draft risk evaluations from state and local governments, labor and health groups, environmental non-governmental organizations (NGO), and members of the scientific community.  EDF reports that during the first several peer reviews conducted by EPA’s Scientific Advisory Committee on Chemicals (SACC), many of the SACC members raised similar concerns.  According to EDF, EPA has directed SACC “that these issues are off-limits to the peer reviewers because they represent policy decisions that are beyond the charge given to the SACC.”  EDF states that “[t]his is beyond the pale” for the following reasons:

  1. Such issues fall squarely within SACC’s charge.  EPA’s charge questions to SACC for its most recent peer review of 1-bromopropane (1-BP) “specifically (and appropriately) call on the SACC to comment on the ‘assumptions, uncertainties and data limitations in the methodology used to assess risks from 1-BP’”;
     
  2. It is “absolutely” SACC’s role and responsibility to comment on the scientific consequences of EPA’s decisions that directly affect its characterization of exposure, hazard, and risk; and
     
  3. With respect to the adequacy of the information on which EPA relies, EPA “has recently made an additional claim to the SACC:  that EPA has no choice but to use the data it has readily at hand, however limited they are.”

EDF concludes that EPA’s direction to SACC “is but the latest in a series of moves to limit the scientific information and scientific advice that EPA can obtain and use to make decisions.”


 
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By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) announced on September 18, 2019, that it is now accepting nominations for the 2020 Green Chemistry Challenge Awards for companies or institutions that have developed a new process or product that helps protect public health and the environment.  EPA defines green chemistry as the design of chemical products and processes that reduce both the generation and use of chemicals that are hazardous to the environment and people’s health.  Nominations for innovative technologies featuring the design of greener chemicals and products, greener chemical syntheses and reactions, or greener chemical processes are due to EPA by December 31, 2019.  EPA states that it anticipates giving awards to outstanding green chemistry technologies in five categories in June 2020.  According to EPA, since the inception of the awards more than two decades ago, it has received more than 1,600 nominations and presented awards to 118 technologies that reduced the use or generation of hundreds of millions of pounds of hazardous chemicals and saved billions of gallons of water and trillions of BTUs in energy.  An independent panel of technical experts convened by the American Chemical Society Green Chemistry Institute will formally judge the 2020 nominations and make recommendations to EPA for the 2020 winners.


 
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By Lynn L. Bergeson and Carla N. Hutton

On September 3, 2019, Earthjustice filed with the U.S. Environmental Protection Agency (EPA) a notice of intent to sue EPA under Section 20(a)(2) of the Toxic Substances Control Act (TSCA) for “EPA’s repeated and ongoing failures to comply with TSCA’s nondiscretionary mandates to disclose to the public information about new chemical substances reviewed by EPA.”  According to Earthjustice, EPA “routinely fails to disclose” certain information regarding the submission and review of new chemical applications under the premanufacture notification (PMN) and test marketing exemption (TME) provisions.  Earthjustice states that these violations impede the ability of the listed parties -- the Environmental Defense Fund, Center for Environmental Health, Environmental Health Strategy Center, Natural Resources Defense Council, Sierra Club, and the United Steel, Paper and Forestry, Rubber, Manufacturing, Energy, Allied Industrial Service Workers International Union, AFL-CIO/CLC -- “to be meaningfully informed of and able to participate in EPA’s review of new chemicals.”  Earthjustice asks that EPA immediately cease further violations of TSCA’s disclosure requirements for new chemicals and disclose the information to which the listed parties are legally entitled in the mandated time frames. A detailed analysis and commentary on the notice are available in our September 17, 2019, memorandum, “Earthjustice Notifies EPA of Intent to Sue for Failure to Disclose Information about New Chemical Substances.”

Tags: NOI, PMN, TME

 
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By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) issued a press release on September 10, 2019, announcing that EPA Administrator Andrew Wheeler signed a directive to prioritize efforts to reduce animal testing.  Administrator Wheeler also announced $4.25 million in funding to five universities to research the development and use of alternative test methods and strategies that reduce, refine, and/or replace vertebrate animal testing.  Administrative Wheeler directs the Office of Chemical Safety and Pollution Prevention (OCSPP) and the Office of Research and Development (ORD) “to prioritize ongoing efforts and to direct existing resources toward additional activities that will demonstrate measurable impacts in the reduction of animal testing while ensuring protection of human health and the environment.”  The directive states that EPA “will reduce its requests for, and [its] funding of, mammal studies by 30 percent by 2025 and eliminate all mammal study requests and funding by 2035.  Any mammal studies requested or funded by the EPA after 2035 will require Administrator approval on a case-by-case basis.”  Administrative Wheeler requests that OCSPP and ORD hold a joint animal conference on new approach methods (NAM), with the first conference to be held in 2019
 
Five universities were awarded grants through EPA’s Science to Achieve Results Program.  According to EPA, the research focuses on advancing the development and use of alternative test methods and strategies to reduce, refine, and/or replace vertebrate animal testing.  The grantees are advancing the science of non-vertebrate alternative test methods and strategies in chemical hazard assessment.  The grantees include:

  • Johns Hopkins University to develop a human-derived brain model to assess the mechanism by which environmental chemicals might cause developmental neurotoxicity;
     
  • Vanderbilt University to test their organ-on-a-chip to study the blood brain barrier and potential brain injury after organophosphate exposure;
     
  • Vanderbilt University Medical Center to use their Endo Chip technology to research how preexisting diseases affect cellular responses to environmental toxicants with a focus on reproductive disorders in women;
     
  • Oregon State University to develop in vitro test methods for fish species to screen chemicals in complex environmental mixtures; and
     
  • University of California Riverside to use human cells to develop a cost-effective end point to characterize potential skeletal embryotoxicants.

 
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By Lynn L. Bergeson and Carla N. Hutton
 
On September 4, 2019, the U.S. Environmental Protection Agency (EPA) released new guidance intended to help methylene chloride processors and distributors comply with EPA’s March 2019 rule issued under Section 6(a) of the Toxic Substances Control Act (TSCA) prohibiting the manufacture (including import), processing, or distribution in commerce of methylene chloride for consumer paint and coating removal.  The final rule became effective on May 28, 2019.  Each person who manufactures, processes, or distributes in commerce methylene chloride for any use after August 26, 2019, must comply with the requirements for downstream notification and recordkeeping.  The guidance describes the requirements EPA established to address unreasonable risks from the use of methylene chloride in consumer paint and coating removal.  The guidance also:

  • Defines key terms;
  • Identifies the regulated entities;
  • Describes the required or prohibited activities; and
  • Summarizes the downstream notification and recordkeeping requirements.

EPA notes that the small entities directly regulated by the rule include:

  • Processors (since they formulate paint and coating removers containing methylene chloride);
  • Distributors of methylene chloride;
  • Distributors of paint and coating removers containing methylene chloride; and
  • Retailers.

EPA states that the rule is fully effective on November 22, 2019, when prohibitions on manufacturing (including importing), processing, or distributing methylene chloride for consumer paint and coating removal go into effect.  This ban includes a prohibition on distributing any methylene chloride for paint and coating removal to or by retailers, including e-commerce retailers.  More information on EPA’s final rule is available in our March 20, 2019, memorandum, “EPA Bans Consumer Sales of Methylene Chloride Paint Removers, Seeks Comment on Program for Commercial Uses.”


 
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By Lynn L. Bergeson and Lisa R. Burchi
 
In a significant victory for industry, on August 27, 2019, the State of New York Supreme Court invalidated the New York Department of Environmental Conservation (NYDEC) Household Cleansing Product Information Disclosure Program (Disclosure Program).  Information related to NYDEC’s prior delay of its enforcement of its Disclosure Program is available here, and general information regarding the Program and its extensive requirements for manufacturers of certain consumer cleaning products to disclose information regarding the ingredients in those products is available here.
 
Two trade associations, the Household and Commercial Cleaning Products Association (HCPA) and the American Cleaning Institute (ACI) (Petitioners), filed the lawsuit last October.  Petitioners sought declaratory relief and a judgment invalidating the Disclosure Program on the basis that the Program was a “rule” for which NYDEC did not comply with its State Administrative Procedure Act (SAPA) rulemaking procedures.  Petitioners also argued that the Program was established in violation of Article IV Section 8 of the New York State Constitution, was issued in excess of NYDEC’s statutory authority, and was arbitrary and irrational.
 
The court found that the Disclosure Program was established in violation of SAPA and the New York State Constitution.  In making this finding, the court held that the Program was a “rule” as argued by Petitioners and not “guidance” for which adherence to SAPA was not required, as argued by NYDEC.  The court also found that “since there is no opt out provision whereby petitioners may choose to deviate from the program, the Disclosure Program is not mere guidance.”  The Disclosure Program is thus “null and void and the matter is remitted back to DEC with the directive to comply with SAPA.” Since the decision was reached based on violations of SAPA, the court did not address the other bases upon which Petitioners sought to invalidate the Program.  A more detailed analysis and commentary are available in our August 30, 2019, memorandum, “NY Department of Environmental Conservation Household Cleansing Product Information Disclosure Program Ruled ‘Null and Void.’”


 
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