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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.”


 

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). 


 

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."


 

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.


 

By Lynn L. Bergeson and Carla N. Hutton

On June 28, 2019, the U.S. Environmental Protection Agency (EPA) released the draft risk evaluations for cyclic aliphatic bromide cluster (HBCD) and 1,4-dioxane, two of the first ten chemicals undergoing risk evaluation under the amended Toxic Substances Control Act (TSCA).  In its June 28, 2019, press release, EPA states in the draft risk evaluation for HBCD, it did not find unreasonable risk to the general population, consumers, workers, or the environment.  According to EPA, in the draft risk evaluation for 1,4-dioxane, EPA did not find unreasonable risk to the environment, but the data “show there could be unreasonable risks to workers in certain circumstances.”  EPA states:  “It is important to note that for the general population, including children, environmental statutes administered by EPA such as the Clean Air Act, the Safe Drinking Water Act, the Clean Water Act, and the Resource Conservation and Recovery Act, adequately assess and effectively manage risks from 1,4-dioxane.”

On Monday, July 1, 2019, EPA will publish a Federal Register notice announcing the availability of the draft risk evaluations and beginning a 60-day comment period.  The draft risk evaluations will be peer reviewed by the Science Advisory Committee on Chemicals (SACC) on July 29- August 2, 2019.  SACC will hold a preparatory virtual meeting to discuss the scope and clarity of the draft charge questions on July 10, 2019.


 

By Lynn L. Bergeson and Carla N. Hutton
 
On May 16, 2019, the U.S. Court of Appeals for the Ninth Circuit heard oral arguments in a case filed by non-governmental organizations (NGO) challenging the U.S. Environmental Protection Agency’s (EPA) prioritization and risk evaluation rules.  Safer Chemicals, Healthy Families v. EPA, No. 17-72260.  During oral arguments, the court asked the Natural Resources Defense Council (NRDC) whether it had standing to be before the court.  NRDC responded that it does, arguing that EPA’s rules violate the statutory requirements of the Frank R. Lautenberg Chemical Safety for the 21st Century Act.  The court suggested that petitioners could wait to see whether EPA will ignore certain uses of chemicals in its risk evaluations.  EPA maintained that petitioners were raising a challenge to a hypothetical scenario and that EPA has the legal discretion to study whichever chemical uses it sees fit.  Following oral argument, on May 16, 2019, the court ordered petitioners to file a supplemental brief addressing why they should be allowed to bring a lawsuit against EPA.  The petitioners filed their supplemental brief on June 3, 2019, arguing that they have standing because the Toxic Substances Control Act (TSCA) Framework Rules threaten their members’ concrete interests in minimizing toxic chemical exposures; they have information standing for each of their challenges to the Framework Rules; and their claims are ripe.  EPA was granted an extension and its response is due June 28, 2019.


 

By Lynn L. Bergeson and Margaret R. Graham, M.S.

On June 14, 2019, the U.S. Environmental Protection Agency (EPA) announced that on May 24, 2019, EPA received manufacturer requests for EPA to conduct risk evaluations of diisodecyl phthalate (DIDP) from ExxonMobil Chemical Company and diisononyl phthalate (DINP) from ExxonMobil Chemical Company, Evonik Corporation, and Teknor Apex, both through the American Chemistry Council’s High Phthalates Panel.  EPA states that both DIDP and DINP belong to a family of chemicals commonly referred to as phthalates, which are used as plasticizers in the production of plastic and plastic coatings to increase flexibility and were identified in the 2014 Update to the Toxic Substances Control Act (TSCA) Work Plan.

Within 15 business days of receiving a facially complete request (i.e., submission appears to be consistent with rule requirements), EPA states that it must notify the public of receipt of this request under 40 C.F.R. Section 702.37(e)(2); and within 60 business days of receipt of a facially complete request, EPA will submit for publication the receipt of the request in the Federal Register, open a public docket for the request, and provide no less than 45 calendar days for public comment.  After the comment period closes, EPA has up to 60 days to either grant or deny the request to conduct a risk evaluation under 40 C.F.R. Section 702.37(e)(6).  More information on Manufacturer Requests is available on EPA’s website.


 

By Lynn L. Bergeson and Margaret R. Graham, M.S.

On May 9, 2019, the U.S. Environmental Protection Agency (EPA) announced it will hold the first meeting of the Science Advisory Committee on Chemicals (SACC) under the Toxic Substances Control Act (TSCA), for Pigment Violet 29 (PV29), the first chemical of the initial ten chemicals undergoing review, on June 18-21, 2019, from 9:00 a.m. to 5:30 p.m. (EDT) at the Holiday Inn Rosslyn at Key Bridge, Rosslyn Ballroom, 1900 North Fort Myer Drive, Arlington, Virginia.  84 Fed. Reg. 20354.  The meeting may also be available via webcast.

EPA states that the purpose of the SACC meeting is for EPA “to get the independent review of the science underlying the PV29 risk assessment, including the hazard assessment, assessment of dose-response, exposure assessment, and risk characterization.”  Additionally, this meeting will include an orientation on TSCA and how EPA is evaluating chemicals in commerce as prescribed in amended TSCA.  EPA states that it will use the scientific advice, information, and recommendations from the SACC, as well as public comments, to inform the final risk evaluation.  Comments are still being collected on the PV29 risk assessment until May 17, 2019, in Docket No. EPA-HQ-OPPT-2018-0604 on www.regulations.gov.

More information about the June SACC meeting and peer review of PV29 is available on EPA’s website.


 

By Lynn L. Bergeson and Margaret R. Graham, M.S.

On April 17, 2019, the U.S. Environmental Protection Agency (EPA) announced the availability of updated systematic review supplemental files with data evaluation scoring sheets as supporting documents for the draft risk evaluation for Colour Index (C. I.) Pigment Violet 29 (PV29) under the Toxic Substances Control Act (TSCA).  84 Fed. Reg. 16011.  EPA states it is “seeking public comment on the draft risk evaluation for PV29 in light of the additional materials already made or being made publicly available.”  In her April 16, 2019, blog item, Alexandra Dapolito Dunn, Assistant Administrator, EPA Office of Chemical Safety and Pollution Prevention, described the updated systematic review documents for PV29 as “a tool that guides our review and selection of scientific studies used to evaluate chemicals,” and that the updates were made “based on public input we received during the initial comment period.” 

On March 22, 2019, EPA made 24 full study reports on PV29 available to the public, in some instances with information withheld as confidential business information (CBI) pursuant to EPA regulations.  EPA has considered these materials in the risk evaluation process of PV29 and has also submitted these materials to the TSCA Science Advisory Committee on Chemicals (SACC).  EPA states that comments submitted will be considered by the agency and also provided to the TSCA SACC peer review panel, which will have the opportunity to consider the comments during its discussions. 

The comment period for the draft risk evaluation of CI PV29 closed on January 14, 2019, but via this notice is being extended.  The Federal Register notice announcing the availability of the updated systematic review supplemental files lists a comment deadline of the same date as the notice -- April 17, 2019, but Docket ID EPA-HQ-OPPT-2018-0604-0038, however, lists a comment deadline of May 17, 2019; it is most likely that the docket is correct in this instance especially considering that follows what was stated by Ms. Dunn in her blog item that in light of the new and updated information EPA has recently released, "we will be reopening the public comment on the draft risk evaluation for PV29. It is important that the public have the opportunity to provide input on all of the information EPA is considering before our risk evaluation is finalized, so we invite you to provide us with your feedback. The public comment period will reopen for 30 days following publication in the Federal Register.” 


 

By Lynn L. Bergeson and Margaret R. Graham, M.S.

On March 22, 2019, the U.S. Environment Protection Agency (EPA) issued a memorandum stating that it was releasing 24 studies in the Colour Index (C.I.) Pigment Violet (PV) 29 docket (Docket No. EPA-HQ-OPPT-2018-0604) that were reviewed by EPA to develop its Draft Risk Evaluation for C.I. PV 29.  EPA states that these studies are being made available to the public prior to the Toxic Substances Control Act (TSCA) Science Advisory Committee on Chemicals (SACC) expert panel peer review of the draft risk evaluation.  That entirety of the reports was originally erroneously claimed to be confidential business information (CBI), therefore, the reports were not included in the public docket previously.   Fifteen of the study reports have been released without any redactions while nine reports were partially redacted.  EPA provides a full list of the studies and their confidential status in the memorandum.  The 24 study reports represent the following disciplines:  #1-17 Human Health; #18-20 Environmental Hazard; #21-22 Environmental Fate, and #23-24 Physical Chemical properties.  Twenty of the 29 studies made available in the dockets were summarized in the European Chemicals Agency’s (ECHA) registration dossier for C.I. PV 29; EPA refers to them as “robust summaries” and states that it has compared the information contained in the robust summaries against the information contained in the study reports for accuracy.  They were posted to the docket in November 2018. 


 
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