Bergeson & Campbell, P.C. (B&C®) is a Washington, D.C. law firm providing chemical and chemical product stakeholders unparalleled experience, judgment, and excellence in matters relating to TSCA, and other global chemical management programs.
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By Lynn L. Bergeson and Carla N. Hutton

 

The U.S. Environmental Protection Agency (EPA) announced on 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 will be available in our forthcoming memorandum.


 
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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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By Lynn L. Bergeson and Carla N. Hutton

The U.S. Environmental Protection Agency (EPA) announced on August 1, 2019, that it is making additional information about new chemical notices available on its website.  The new web page, “Statistics for the New Chemicals Review Program under TSCA,” allows users to view and search monthly updates for any active Premanufacture Notice (PMN), Significant New Use Notice (SNUN) and Microbial Commercial Activity Notice (MCAN) of interest by case number.  Users can also download a spreadsheet with a list of all active cases and each case’s status.  More information and commentary is available in our August 5, 2019, memorandum, "EPA Improves Transparency for New Chemicals Review Program under TSCA."


 
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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.


 
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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.


 
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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.”


 
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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.


 
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By Lynn L. Bergeson and Carla N. Hutton
 
The House Science, Space, and Technology Subcommittee on Research and Technology will hold a hearing on “Benign by Design:  Innovations in Sustainable Chemistry” on July 25, 2019.  Witnesses will include:

  • Dr. Tim Persons, Chief Scientist and Managing Director, Science, Technology Assessment, and Analytics, U.S. Government Accountability Office (GAO);
     
  • Dr. John Warner, President and Chief Technology Officer, Warner Babcock Institute for Green Chemistry;
     
  • Dr. Julie Zimmerman, Professor and Senior Associate Dean, School of Forestry and Environmental Studiesa and Deputy Director, Center for Green Chemistry and Green Engineering, Yale University;
     
  • Ms. Anne Kolton, Executive Vice President, Communications, Sustainability, and Market Outreach, American Chemistry Council; and
     
  • Mr. Mitchell Toomey, Director of Sustainability, BASF in North America.

 
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By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) has published statistics concerning its review of confidential business information (CBI) cases received between June 22 2016, and June 25, 2019.  The Frank R. Lautenberg Chemical Safety for the 21st Century Act, enacted in 2016, amended the CBI provisions of the Toxic Substances Control Act (TSCA).  Since then, EPA “has established numerous new processes, systems, and procedures to enable submitters to provide the information required when making confidentiality claims and to facilitate EPA's review, and where applicable, determinations on these claims.”  According to EPA, the statistics show EPA's progress toward meeting the requirements of TSCA Section 14(g).  EPA uses “case” to describe a submission made under a specific section of TSCA and all subsequent submissions and amendments by the same submitter that relate back to the first submission. 

CBI Review Statistics (cases received between June 22, 2016 and June 25, 2019)
Cases in which the specific chemical identity is subject to CBI review 2,177
Cases in which information other than the specific chemical identity is subject to CBI review 2,305
Cases in which both the specific chemical identity and information other than the specific chemical identity is subject to CBI review 587
Total cases subject to CBI review 5,069

 

Cases resulting in final CBI determinations
Cases with all CBI claims subject to review, approved 523
Cases with all CBI claims subject to review, denied 5
Cases with CBI claims subject to review, approved-in-part/denied-in-part 34
Cases with all CBI claims subject to review, denial - appeal period pending* 10
Total cases resulting in final CBI determinations 572

 * “Denial - appeal period pending” cases are those for which a CBI determination denying one or more CBI claims in a case has been issued to the submitter of the information, but for which the required 30-day notification period following receipt of the determination under TSCA Section 14(g)(2)(B) has not yet passed.

Cases reviewed with no final CBI determination necessary
Cases with all CBI claims screened and found to be exempt from review 1,068
Cases with all CBI claims withdrawn by submitter 415
Cases identified for CBI review, for which no determination required (e.g., in some instances, older EPA information systems do not specifically identify which information is claimed as CBI and upon review, it is determined that no claims require review) 1,012
Total cases reviewed/screened with no final CBI determination necessary 2,495

 

Cases currently undergoing CBI review
Cases currently undergoing CBI review 2,002

EPA states that later this year, it plans to publish a comprehensive list of cases subject to CBI review to be updated quarterly.  The table will include information showing the results of individual cases with completed reviews.

Tags: CBI, Section14

 
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By Lynn L. Bergeson and Carla N. Hutton
 
Earlier this month, David Fischer joined the U.S. Environmental Protection Agency’s (EPA) Office of Chemical Safety and Pollution Prevention (OCSPP) as a Deputy Assistant Administrator.  Prior to joining EPA, Mr. Fischer was most recently a partner of legal and regulatory affairs at IBEX Partners LLC, a public affairs firm.  Before his partnership at IBEX, Mr. Fischer held several senior positions at the American Chemistry Council in its Office of General Counsel and Chemical Products and Technology Division, providing legal and policy counsel on a broad range of industrial, specialty chemical, and product defense matters.  Earlier in his career, Mr. Fischer was also the Director of Environmental Health at the Association of State and Territorial Health Officials, where he led the first national assessment of state activities in lead poisoning prevention. 


 
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By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) announced on July 15, 2019, that it will cease sending notices of deficiency to businesses that submit procedurally flawed confidential business information (CBI) claims under the Toxic Substances Control Act (TSCA).  This is a significant change from the interpretation EPA announced in January 2017, and a company’s failure to appreciate its consequences could prove damaging.  Effective August 15, 2019, EPA will provide written notice to affected business submitters that because they submitted procedurally flawed CBI claims, including unsubstantiated CBI claims, those CBI claims are invalid, and the underlying information is not protected from disclosure under TSCA Section 14.  EPA states in the Federal Register notice issued on July 16, 2019, that under its 2017 interpretation, it undertook a “non-statutorily required practice of sending a notice of deficiency to an affected business that submitted a non-exempt CBI claim without a substantiation, providing an opportunity to correct the deficiency.”  84 Fed. Reg. 33939.  Under the new policy, EPA will provide written notice to affected business submitters that because they submitted procedurally flawed CBI claims, including unsubstantiated CBI claims, those CBI claims are invalid, and the underlying information is not protected from disclosure under TSCA Section 14.  EPA notes that unlike the notice of deficiency, this written notice will not provide affected businesses 30 calendar days to remedy their deficient CBI claims.  Instead, the written notice will inform affected businesses that their “procedurally flawed” CBI claims may be disclosed to the public without further notice.  More information is available in our July 16, 2019, memorandum, “EPA Announces Important New Policy on TSCA CBI Claims of Deficiency.”


 
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By Lynn L. Bergeson and Carla N. Hutton
 
On June 28, 2019, the U.S. Environmental Protection Agency (EPA) filed its response to the non-governmental organizations’ (NGO) supplemental brief in a case challenging EPA’s prioritization and risk evaluation rules.  Safer Chemicals, Healthy Families v. EPA, No. 17-72260.  According to EPA, petitioners “have plausibly alleged standing to challenge only the definitional interpretation of ‘conditions of use’ and the two provisions still subject to EPA’s motion for voluntary remand.”  As to the remainder of petitioners’ claims, EPA maintains that their allegations “are based on hypotheticals and other non-final agency actions currently being considered by the agency.”  EPA argues that the court should dismiss petitioners’ challenges to:  (1) EPA’s preamble statements about the potential scope of future risk evaluations; (2) EPA’s regulatory provisions leaving the door open to issue early risk determinations; and (3) the remaining information-gathering provisions still at issue.  EPA states that if it “ever takes final agency actions based on the decisions Petitioners hypothesize, those would be the proper actions for Petitioners’ challenges.”
 
A coalition of industry associations filed a supplemental brief in support of EPA on June 28, 2019.  The coalition states:  “Although it is theoretically possible that EPA could exclude a use of a particular chemical that could affect the risk evaluation in a way that could cause the agency not to regulate some use of a chemical that could injure Petitioners’ members, that does not create a justiciable controversy now, before the Rules have been applied.”  (Emphasis in original.)  The coalition asks the court to dismiss the petitions for lack of jurisdiction.
 
As reported in our June 26, 2019, blog item, the U.S. Court of Appeals for the Ninth Circuit heard oral arguments on May 16, 2019, and afterward ordered petitioners to file a supplemental brief addressing why they should be allowed to bring a lawsuit against EPA.


 
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