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 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 will be available in our forthcoming memorandum, which will be posted on our website.

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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By Lynn L. Bergeson, Richard E. Engler, Ph.D., and Kathleen M. Roberts

The cost of generating health and safety studies is considerable and data owners have every right to expect some protection from disclosure to preserve the value of their intellectual property.  This is no longer guaranteed as Lynn L. Bergeson, Richard E. Engler, Ph.D., and Kathleen M. Roberts wrote in a two-part article in Bloomberg Environment Insights. The authors propose that the U.S. Environmental Protection Agency’s (EPA) practice of disclosing entire health and safety studies voluntarily submitted under Toxic Substances Control Act (TSCA) Section 6 is based upon a misinterpretation of TSCA Section 14(b)(2)(A)(i) and should be reconsidered in light of a recent judicial decision and the pressing need to acknowledge the global relevance of health and safety studies. 
 
Many of the studies that will be relevant to EPA’s risk evaluations under TSCA Section 6 have significant monetary and competitive value, and data owners have every right to expect some protection from the disclosure of the study reports to preserve their value. If EPA as a matter of practice routinely posts entire study reports publicly, the reports would be rendered valueless for data compensation purposes. Some organizations have considered approaches that include the selective claiming of certain information elements in the study report as confidential to protect the value of the research while providing relevant information on the general findings and health and safety effects observed in the study. It is unclear, however, if this practice provides other stakeholders with sufficient information or if this practice is entirely effective in preserving the monetary and competitive value of the study report. EPA’s insistence that those who send in study reports accept the fact that the entire submission will be posted publicly also ignores the reality that many of these reports are jointly owned. Multiple entities often have title to the study as joint owners and its disclosure is generally subject to data sharing agreements that expressly prohibit its publication unless required by law.
 
Despite these concerns with the interpretation of TSCA Section 14(b)(2)(A)(i), submitters need to up their game, as it were, in identifying confidential business information (CBI) and certifying that release of such information would pose “substantial commercial harm.” For more information on the greater burden being placed on submitters, and for possible options to protect CBI, read the full article “Protecting the Value of Health, Safety Studies—Emerging TSCA Issues” online.


 
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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.”


 
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By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) announced on August 22, 2019, the appointment of Dennis Deziel as Regional Administrator for Region 1.  Mr. Deziel will oversee environmental protection efforts in the states of Maine, New Hampshire, Vermont, Massachusetts, Rhode Island, and Connecticut and in ten Tribal Nations.  According to EPA, Mr. Deziel has spent much of his life working in public service in Washington, D.C.  He most recently worked at Dow as the Director of Federal Government Affairs, where he focused on environment, energy, and regulatory affairs issues.  Prior to entering private industry, Mr. Deziel served as Deputy Assistant Secretary in the Office of Environmental Management at the U.S. Department of Energy from 2012 to 2014, leading budget, policy, and planning development for the largest environmental cleanup program in the United States.  He also managed chemical security issues at the U.S. Department of Homeland Security from 2004 to 2010, and prior to that, he served as a policy advisor for the Council for Environmental Quality from 2002 to 2004.  EPA notes that Mr. Deziel began his career working at EPA in the pesticides and chemicals program.


 
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By Lynn L. Bergeson and Carla N. Hutton

On August 23, 2019, the U.S. Environmental Protection Agency (EPA) published a Federal Register notice proposing to designate 20 chemical substances as high-priority substances for risk evaluation under the Toxic Substances Control Act (TSCA).  84 Fed. Reg. 44300.  The notice includes a summary of the approach used by EPA to support the proposed designations, the proposed designation for each of the chemical substances, and instructions on how to access the chemical-specific information, analysis, and basis used by EPA to make the proposed designation for each chemical substance.  Comments are due November 21, 2019.  More information is available in our August 26, 2019, memorandum, "EPA Proposes to Designate 20 Chemical Substances as High-Priority Substances for Risk Evaluation under TSCA."


 
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By Lynn L. Bergeson and Carla N. Hutton

The U.S. Environmental Protection Agency (EPA) posted an August 7, 2019, petition for rulemaking submitted by the Public Employees for Environmental Responsibility (PEER) under Section 21 of the Toxic Substances Control Act (TSCA).  PEER asks that oil refineries be prohibited from using hydrofluoric acid in their manufacturing processes and that oil refineries be required to phase out the use of hydrofluoric acid within two years.  According to PEER, TSCA and the Clean Air Act (CAA) regulate hydrofluoric acid and provide the statutory authority for EPA to issue a regulation prohibiting the use of hydrofluoric acid in oil refineries.  PEER states that under TSCA, EPA “possesses the power to promulgate rules banning chemicals that pose an unreasonable risk to human health.”  If the EPA Administrator determines that the “manufacture, processing, distribution in commerce, use, or disposal of a chemical substance . . . presents an unreasonable risk of injury to health or the environment,” TSCA Section 6(a) provides EPA the authority to prohibit or otherwise restrict “the manufacture, processing, or distribution in commerce of such substance or mixture for (i) a particular use.”  PEER argues that the EPA Administrator could ban the use of hydrofluoric acid in refineries if the Administrator found that its use in that context presented an unreasonable risk to health or the environment.  PEER maintains that the use of hydrofluoric acid presents such a risk.

EPA sent a letter to PEER on August 16, 2019, confirming receipt of its petition and noting that Section 21 provides the Administrator 90 days to grant or deny the petition.  If the EPA Administrator grants the petition, the Administrator will “promptly commence an appropriate preceding [sic].”  If the Administrator denies the petition, the Administrator will publish the reasons for the denial in the Federal Register.


 
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By Lynn L. Bergeson and Carla N. Hutton

On August 20, 2019, the U.S. Environmental Protection Agency (EPA) published in the Federal Register final significant new use rules (SNUR) under the Toxic Substances Control Act (TSCA) for 145 chemical substances that are the subject of premanufacture notices (PMN).  84 Fed. Reg. 43266.  According to EPA, the chemical substances are subject to orders issued by EPA pursuant to TSCA Section 5(e).  The final SNURs require persons who intend to manufacture (defined by statute to include import) or process any of the 145 chemical substances for an activity that is designated as a significant new use by the rule to notify EPA at least 90 days before commencing that activity.  The required notification initiates EPA’s evaluation of the use, under the conditions of use for that chemical substance, within the applicable review period.  Persons may not commence manufacture or processing for the significant new use until EPA has conducted a review of the notice, made an appropriate determination on the notice, and taken such actions as are required by that determination.  The final SNURs will take effect October 21, 2019.

EPA notes that the final SNURs may also affect certain entities through pre-existing import certification and export notification rules under TSCA.  Chemical importers are subject to TSCA Section 13 import certification requirements.  Chemical importers must certify that the shipment of the chemical substance complies with all applicable rules and orders under TSCA.  Importers of chemicals subject to the SNURs must certify their compliance with the SNUR requirements. Any persons who export or intend to export a chemical substance that is the subject of the SNURs on or after September 19, 2019, are subject to the export notification provisions of TSCA Section 12(b) and must comply with export notification requirements.

Tags: SNUR

 
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By Lynn L. Bergeson and Carla N. Hutton

The U.S. Environmental Protection Agency (EPA) announced on August 16, 2019, that it is opening a public comment period for manufacturer requests for the risk evaluations of diisodecyl phthalate (DIDP) and diisononyl phthalate (DINP), two chemicals used in plastic production.  EPA notes that the manufacturer-requested risk evaluations “are among the first such evaluations of this kind to be requested” under the Toxic Substances Control Act (TSCA).  EPA is also taking public comments on additional conditions of use it identified to include in the risk evaluations.  Upon publication of the Federal Register notices, comments may be submitted to Docket ID EPA-HQ-OPPT-2018-0435 for DIDP and Docket ID EPA-HQ-OPPT-2018-0436 for DINP for 45 days.  EPA encourages comments on any information not included in the manufacturer requests that commenters believe would be needed to conduct a risk evaluation.  EPA also welcomes any other information relevant to the proposed determinations of the conditions of use, including information on other conditions of use of the chemicals than those included in the manufacturer requests or in EPA’s proposed determinations.  After the comment period closes, EPA will review the comments and within 60 days either grant or deny the requests to conduct risk evaluations.  If these requests are granted, the manufacturers would be responsible for half the cost of the risk evaluations.  More information is available in our August 19, 2019, memorandum, "EPA Begins Comment Period on Manufacturer Requests for Risk Evaluation of DIDP and DINP, and Identifies Additional Conditions of Use."


 
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By Carla N. Hutton, Richard E. Engler, Ph.D., and Amanda Bland
 
On August 13, 2019, the U.S. Environmental Protection Agency (EPA) released the list of 20 chemical substances that it proposes to designate as low-priority substances for which risk evaluation under the Toxic Substances Control Act (TSCA) is not warranted at this time.  EPA’s August 15, 2019, proposed rule provides a summary of the approach used by EPA to support the proposed designations, the proposed designations for each of the chemical substances, and instructions on how to access the chemical-specific information, analysis, and basis used by EPA to make the proposed designation for each chemical substance.  84 Fed. Reg. 41712.  EPA published its Approach Document for Screening Hazard Information for Low-Priority Substances Under TSCA (Approach Document), which describes the literature review process for the information used in the screening review for each proposed low-priority chemical substance.  Comments on the proposed designations and on EPA’s Approach Document are due November 13, 2019.

Commentary

As expected, EPA has formally proposed as low-priority substances the 20 substances that EPA proposed in March as potential low-priority substances.  Stakeholders will have 90 days to comment on whether EPA has met the statutory obligation to have information “sufficient to establish” that the substances do not meet the standard for high-priority substances (that the substances may present an unreasonable risk).  Comments were filed on only seven of the 20 substances initially identified as low priority, and all comments supported the designations as low priority. 
 
More information is available in our August 14, 2019, memorandum, “EPA Proposes to Designate 20 Chemical Substances as Low-Priority Substances.”


 
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By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) has named Dr. Lynn Dekleva as Associate Deputy Assistant Administrator for New Chemicals.  Dr. Dekleva joined EPA in October 2018 as a Science Advisor, working to streamline and improve EPA’s processes and timeliness concerning the review of new chemicals under the Frank R. Lautenberg Chemical Safety for the 21st Century Act.  Dr. Dekleva is an environmental engineer with degrees in environmental microbiology, medical technology, and biology.  Her contributions are expected to help EPA meet the ambitious mandates of the amended Toxic Substances Control Act (TSCA).


 
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By Lynn L. Bergeson and Carla N. Hutton
 
Section 5(g) of the Toxic Substances Control Act (TSCA) requires the U.S. Environmental Protection Agency (EPA) to publish a statement of its findings after its review of TSCA Section 5(a) notices when EPA makes a finding that a new chemical substance or significant new use is not likely to present an unreasonable risk of injury to health or the environment.  On August 12, 2019, EPA published a statement of its findings for June 2019.  84 Fed. Reg. 39828.  EPA notes that such statements apply to premanufacture notices (PMN), microbial commercial activity notices (MCAN), and significant new use notices (SNUN) submitted to EPA under TSCA Section 5.  In the Federal Register notice, EPA provides the following information (to the extent that such information is not claimed as confidential business information (CBI)) on the PMNs, MCANs, and SNUNs for which, during this period, EPA has made findings under TSCA Section 5(a)(3)(C) that the new chemical substances or significant new uses are not likely to present an unreasonable risk of injury to health or the environment:  EPA case number assigned to the TSCA Section 5(a) notice; chemical identity (generic name, if the specific name is claimed as CBI); and website link to EPA’s decision document describing the basis of the “not likely to present an unreasonable risk” finding made by EPA under TSCA Section 5(a)(3)(C). 


 
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By Lynn L. Bergeson and Carla N. Hutton

The U.S. Environmental Protection Agency (EPA) released on August 9, 2019, the draft risk evaluation for 1-bromopropane (1-BP), the fourth of the first ten chemicals undergoing risk evaluation under the amended Toxic Substances Control Act (TSCA).  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 states that these initial determinations may change as its evaluation becomes more refined through the public and peer review process.  The draft risk evaluation, including initial risk determinations as to whether the chemical under the conditions of use presents an unreasonable risk to human health or the environment, is not final.  If unreasonable risk is found for one or more conditions of use in a final risk evaluation, EPA will propose actions to address those risks within the timeframe required by TSCA.

The TSCA Science Advisory Committee on Chemicals (SACC) will peer review the draft risk evaluation at a September 10-12, 2019, meeting.  EPA will hold a preparatory virtual meeting on August 21, 2019, to discuss the scope and clarity of the draft charge questions to SACC.  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."


 
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