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
 
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,

 

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.

 

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.”


 

By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency’s (EPA) Toxic Substances Control Act Science Advisory Committee on Chemicals (TSCA SACC) will peer review EPA’s draft risk evaluation for 1-bromopropane (1-BP) on September 10-12, 2019.  The meeting will be held at the Hyatt Regency Crystal City at Reagan National Airport, 2799 Jefferson Davis Highway, Arlington, Virginia.  As reported in our August 9, 2019, blog item, EPA released the draft risk evaluation for 1-BP on August 9, 2019.  EPA made the following initial determinations on risk:

  • Unreasonable risks to workers, occupational non-users, and consumers under certain conditions of use.  EPA notes that these initial determinations are not its final determinations on whether 1-BP presents unreasonable risks under the conditions of use.  EPA states that it will use feedback received from the public and peer review processes to inform the final risk evaluations.
     
  • No unreasonable risk to the environment.  For all the conditions of use included in the draft risk evaluation, EPA found no unreasonable risks to the environment from 1-BP.

EPA requests comments on the draft risk evaluation by August 30, 2019, to allow SACC time to review and consider them before the peer review meeting.  Comments received after August 30, 2019, and prior to the end of the oral public comment period during the meeting will still be provided to the SACC for their consideration.  EPA will continue to accept comments on the draft risk evaluations until October 11, 2019.  EPA will consider all comments received on the draft risk evaluations by the October 11, 2019, deadline when developing the final risk evaluation.  More information is available in our August 12, 2019, memorandum, “EPA Draft Risk Evaluation for 1-BP Finds Unreasonable Risks to Workers, Occupational Non-Users, Consumers, and Bystanders under Certain Specific Uses.”


 

By Lynn L. Bergeson, Richard E. Engler, Ph.D., and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) published a Federal Register notice on May 15, 2019, announcing the availability of a signed action identifying chemical substances for inactive designation according to the Toxic Substances Control Act (TSCA) Inventory Notification (Active-Inactive) Requirements rule.  84 Fed. Reg. 21772.  The signed action, dated May 6, 2019, initiated a 90-day period after which substances identified as inactive will be designated as inactive.  Inactive designations for chemical substances on the TSCA Chemical Substance Inventory are effective on Monday, August 5, 2019.  Beginning August 5, 2019, manufacturers and processors will be required to notify EPA before reintroducing into commerce a substance currently identified as inactive on the TSCA Inventory.  Manufacturers and processors can notify EPA via a Notice of Activity (NOA) Form B, found in EPA’s Central Data Exchange (CDX).  Upon receiving such notification, EPA will change the designation of substances from inactive to active.  Our July 31 2019, memorandum, “EPA Posts NOA Form B Materials before TSCA Inventory Inactive Designations Take Effect August 5,” provides links to EPA materials intended to help manufacturers and processors prepare for the inactive designations taking effect, as well as a detailed commentary.  Companies with additional questions should contact .(JavaScript must be enabled to view this email address) or .(JavaScript must be enabled to view this email address)., for assistance.


 

By Lynn L. Bergeson and Carla N. Hutton
 
On July 29, 2019, the U.S. Environmental Protection Agency (EPA) published in the Federal Register 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 due September 27, 2019.  Our June 24, 2019, memorandum, “EPA Publishes Proposed PBT Chemicals Rule under TSCA,” provides a detailed review and analysis.


 

By Lynn L. Bergeson and Kathleen M. Roberts
 
In the March 27, 2019, Federal Register, the U.S. Environmental Protection Agency (EPA) issued its final regulatory rulemaking that prohibits the manufacture (including import), processing, and distribution of methylene chloride for consumer paint and coating removal. 84 Fed. Reg. 11420.  See Bergeson & Campbell, P.C.’s memorandum, “EPA Bans Consumer Sales of Methylene Chloride Paint Removers, Seeks Comment on Program for Commercial Uses.”
 
Starting on August 26, 2019, which is 90 days after the effective date of the final rule, a company that manufactures, processes, or distributes in commerce methylene chloride is required to provide notification to downstream users of the consumer use paint remover restrictions via Safety Data Sheets (SDS).  We write to emphasize that this notification requirement applies to all manufacturers, processors, or distributors of methylene chloride and is not limited only to those companies engaged with paint remover products.  The EPA rulemaking provides the following specific text that must be included in the SDS:

  • SDS Section 1.(c):  “This chemical/product is not and cannot be distributed in commerce (as defined in TSCA section 3(5)) or processed (as defined in TSCA section 3(13)) for consumer paint or coating removal.”
     
  • SDS Section 15:  “This chemical/product is not and cannot be distributed in commerce (as defined in TSCA section 3(5)) or processed (as defined in TSCA section 3(13)) for consumer paint or coating removal.”

More information is available in our July 22, 2019, memorandum, “Communication and Recordkeeping Requirements Related to EPA Ban on Consumer Use Paint Removers Containing Methylene Chloride Go in Effect on August 26, 2019.”


 

Bergeson & Campbell, P.C. (B&C®) is pleased to present the complimentary webinar “New TSCA at 3: Key Implementation Issues.” The webinar will drill down on key implementation challenges facing industry and the U.S. Environmental Protection Agency (EPA) three years into navigating the legal, regulatory, and science policy issues arising under the Frank R. Lautenberg Chemical Safety for the 21st Century Act (Lautenberg Act). Alexandra Dapolito Dunn, Assistant Administrator, EPA Office of Chemical Safety and Pollution Prevention (OCSPP); Lynn L. Bergeson, Managing Partner, B&C; and Richard E. Engler, Ph.D., Director of Chemistry, B&C, will present. Register online now.


 

By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) published a Federal Register notice on June 28, 2019, announcing that the EPA Safer Choice Program is accepting submissions for its 2019 Safer Choice Partner of the Year Awards.  84 Fed. Reg. 31066.  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.”  Toward this end, according to EPA, the Safer Choice Program certifies products containing ingredients that have met the Program's “specific and rigorous human health and environmental toxicological criteria.”  The Safer Choice Program allows the use of its label on products that perform and contain safer ingredients, as determined by expert evaluation.  According to EPA, recognition by the Safer Choice Program represents a high level of achievement in formulating products that are safer for people and the environment.  EPA states that the purpose of the Partner of the Year Awards “is to recognize the leadership contributions of Safer Choice partners and stakeholders who, over the past year, have shown outstanding achievement in the design, manufacture, selection, and use of products with safer chemicals.”  All Safer Choice stakeholders and Program participants in good standing are eligible for recognition.  According to the notice, interested parties must inform the Program that they would like to be considered for an award and submit supporting information.  Submissions are due July 31, 2019.  EPA will recognize award winners at a Safer Choice Partner of the Year Awards ceremony in fall 2019.

Tags: Safer Choice,

 

By Lynn L. Bergeson and Carla N. Hutton
 
On June 28, 2019, a coalition of 11 state attorneys general filed a lawsuit in the U.S. District Court for the Northern District of California against the U.S. Environmental Protection Agency (EPA) for its failure to initiate an asbestos reporting rule under Section 8(a) of the Toxic Substances Control Act (TSCA).  The complaint argues that EPA wrongfully denied the states’ January 31, 2019, petition, filed under TSCA Section 21, to issue a rule for the reporting of the manufacture, import, and processing of asbestos.  More information on the petition is available in our February 1, 2019, blog item, and more information on EPA’s denial is available in our January 4, 2019, blog item.
 
According to the coalition, the rulemaking they requested is necessary under TSCA, and the denial of their petition was arbitrary and capricious and violates EPA’s obligations under TSCA.  The coalition asks the court to compel EPA to initiate a rulemaking and issue a new asbestos reporting rule to:

  • Eliminate “naturally occurring substance” as an exemption for asbestos reporting;
     
  • Require processors of asbestos, as well as manufacturers, including importers, of the chemical substance to adhere to reporting requirements;
     
  • Ensure that the impurities exemption in the Chemical Data Reporting (CDR) rule does not apply to asbestos; and
     
  • Require reporting with respect to imported articles that contain asbestos.

The coalition includes the Attorneys General of California, Connecticut, Hawaii, Maine, Maryland, Massachusetts, Minnesota, New Jersey, Oregon, Washington, and the District of Columbia.


 
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