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 Margaret R. Graham

On September 20, 2017, the U.S. Environmental Protection Agency (EPA) issued a notice in the Federal Register stating that it is extending the compliance date by which submitters of Toxic Substances Control Act (TSCA) submissions containing information claimed as Confidential Business Information (CBI) and filed between June 22, 2016, and March 21, 2017, had to submit to EPA the substantiation required by TSCA Section 14(c)(3) for all information claimed as confidential, other than information exempt from substantiation pursuant to TSCA Section 14(c)(2).  82 Fed. Reg. 43964.  The new deadline for substantiation of these claims is October 19, 2017.  EPA states that this extension is in response to “concerns raised by industry stakeholders regarding the ability for companies to meet the previous September 19, 2017, deadline due to recent severe weather events,” and that it is “providing this additional flexibility for stakeholders because of the impacts of hurricanes Harvey and Irma.”  Further, “because EPA published its interpretation that TSCA section 14(c)(3) requires up front substantiation after some companies had already asserted confidentiality claims subject to TSCA section 14(c)(3), the Agency set a future deadline for submission of substantiations pertaining to those submissions.” 

More information on the CBI substantiation process is available in our memorandum The September 19th CBI Substantiation Deadline Fast Approaching.

Also on September 20, 2017, EPA announced it was scheduling three webinars to assist the regulated community with reporting under the TSCA Inventory Notification (Active-Inactive) rule.  The webinars, scheduled for September 27, 2017, October 25, 2017, and November 29, 2017, from 1:00 p.m. - 3:00 p.m. (ET), will be identical and will include an overview of reporting requirements, a demo of the electronic reporting application (Central Data Exchange (CDX)), and will provide time for questions and answers.  Registration for the webinars is not required.  EPA’s TSCA Inventory webpage contains the information on how to access the webinar.

More information on the TSCA Inventory Notification (Active-Inactive) rule is available in our memorandum EPA Issues Final TSCA Framework Rules.


 
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By Lynn L. Bergeson

The hearing on the nominations of four U.S. Environmental Protection Agency (EPA) officials by the U.S. Senate Committee on Environment and Public Works (EPW) scheduled for September 20, 2017, has been postponed without any specific reasons; a new hearing date has not been provided.  Bergeson & Campbell, P.C. (B&C®) will be monitoring the Senate EPW Committee calendar for the new hearing date.

More information on the nominees is available in our blog item Senate EPW Committee to Hold Hearing on Nominations of EPA Officials.  


 
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By Lynn L. Bergeson and Margaret R. Graham

On September 14, 2017, the U.S. Environmental Protection Agency (EPA) filed a motion in the two Ninth Circuit Court of Appeals cases regarding review of the EPA Toxic Substances Control Act (TSCA) framework rule Procedures for Chemical Risk Evaluation under TSCA:  Safer Chemicals Healthy Families v. EPA, Case No. 17-72260 (filed August 10, 2017); and Environmental Defense Fund v. EPA, Case No. 17-72501 (filed September 6, 2017), requesting that the cases be transferred to the Fourth Circuit and to hold the cases in abeyance.  In the motion, EPA states three reasons why these cases should be transferred:

  1. "It is in the interest of judicial economy for the same court to hear the challenges to both EPA Rules,” and “[a]lthough the two Rules are distinct and have separate administrative records, the parties anticipate that there will be some overlap of issues.”
  2. “It would be more convenient for the parties and conserve travel resources for these cases to be heard in the Fourth Circuit, because all counsel of record are located in Washington, DC, or New York.”
  3. “The Fourth Circuit may be able to resolve the petitions for review more quickly than this Court given the respective complexity of the courts’ dockets.”

In this motion, EPA also requests for these cases to be held in abeyance as it “will conserve party resources to wait until resolution of EPA’s motion to transfer before completing any scheduled filings, particularly because the two have different schedules” and “the deadline for interested persons to file petitions for review of the Prioritization and Risk Evaluation Rules has not yet expired…. additional petitions for review … could be filed as late as October 2, 2017.” 

In Case No. 17-72260, Petitioners’ briefs are due October 30, 2017, and Respondent EPA’s briefs are due November 28, 2017.  A briefing schedule has not been scheduled yet in Case No. 17-72501.  On September 11, 2017, in Alliance of Nurses for Healthy Environments, et al. v. EPA, Case No. 17-1926, the Fourth Circuit case regarding review of EPA’s TSCA framework rule Procedures for Chemical Risk Evaluation under TSCA, the Fourth Circuit rescinded the briefing schedule.  A new briefing schedule has not been set. 

More information on these petitions for review is available on our blog under key phrases framework rules and petition for review.  


 
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By Lynn L. Bergeson and Margaret R. Graham

The U.S. Senate Committee on Environment and Public Works (EPW) has announced that it will hold a hearing on the following U.S. Environmental Protection Agency (EPA) nominations on Wednesday, September 20, 2017, from 10:00 a.m. to 12:00 p.m. (EDT):

  1. Michael Dourson, Ph.D., for Assistant Administrator of the Office of Chemical Safety and Pollution Prevention (OCSPP).  Dr. Dourson is a professor in the Risk Science Center, Environmental Health, at the University of Cincinnati, Ohio, College of Medicine.  He founded the nonprofit Toxicology Excellence for Risk Assessment and has previously worked at EPA as the Associate Director of the Environmental Criteria and Assessment Office, among other positions.  Dr. Dourson has served in multiple positions at the American Board of Toxicology, Society of Toxicology, Society for Risk Analysis, and Toxicology Education Foundation. 
  2. Matthew Leopold, Esquire, for General Counsel.  Mr. Leopold is currently Of Counsel at Carlton Fields Jorden Burt, P.A., and focuses on federal and state administrative cases, federal and state enforcement actions, natural resource matters, and pollution cleanup issues, especially as they relate to electric utilities.  He previously served as General Counsel for the Florida Department of Environmental Protection from 2013 to 2015 and as an attorney for the U.S. Department of Justice, Environment and Natural Resources Division, from 2007 to 2013. 
  3. David Ross, Esquire, for Assistant Administrator for Water.  Mr. Ross currently serves as the Director of the Environmental Protection Unit for the Wisconsin Department of Justice where he is responsible for representing the Wisconsin Department of Natural Resources and the State of Wisconsin in federal and state court, including defending agency decisions, prosecuting environmental enforcement cases, and providing legal and policy advice on environmental and natural resources issues.  Prior to this, he served as the Senior Assistant Attorney General in the Wyoming Attorney General’s Office from 2014 to 2016, and from 2002 to 2014, he practiced law at three Washington, D.C. law firms in their environmental groups.
  4. William L. Wehrum, Esquire, for Assistant Administrator for Air and Radiation.  This position’s jurisdiction includes climate change programs.  Mr. Wehrum is currently a Partner at Hunton & Williams LLP, and focuses on the regulation of oil and gas production and refining operations.  He has a long history with EPA, serving as Counsel to the Assistant Administrator for Air and Radiation from 2001 to 2005, and as the Acting Assistant Administrator for Air and Radiation from 2005 to 2007.  

 
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By Lynn L. Bergeson and Margaret R. Graham

On September 6, 2017, the U.S. Environmental Protection Agency (EPA) published a notice in the Federal Register extending the period for public comments on the candidates for consideration for the Science Advisory Committee on Chemicals from September 5, 2017, to September 17, 2017.  Comments can be submitted online in Docket Identification Number EPA-HQ-OPPT-2016-0713.

EPA is considering candidates for SACC membership listed in the August 26, 2016, Federal Register notice pool of requested nominees; the 29 candidates for membership identified in the December 9, 2016, Federal Register notice; and the additional candidates provided in the August 3, 2017, Federal Register notice.  More information on the background, qualification of members, and the process of obtaining nominees is available in our memorandum EPA Seeks Comment on Nominations to “Augmented” Science Advisory Committee on Chemicals.


 
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By Lynn L. Bergeson and Margaret R. Graham

On September 1, 2017, the Environmental Defense Fund (EDF) filed a petition for review in the U.S Court of Appeals for the D.C. Circuit (No. 17-1201) of the U.S. Environmental Protection Agency’s (EPA) final Toxic Substances Control Act (TSCA) framework rule TSCA Inventory Notification (Active-Inactive) Requirements, published on August 11, 2017 (82 Fed. Reg. 37520). 

This is the third and final challenge by EDF to the framework rules implementing amended TSCA (there are only three framework rules), but the seventh total challenge, as other parties have also petitioned for review.  On August 11, 2017, EDF petitioned for review of the TSCA framework rules Procedures for Chemical Risk Evaluation under TSCA and the final rule Procedures for Prioritization of Chemicals for Risk Evaluation, filed on August 11 (Second Cir. Case Nos. 17-2464 and 17-2403, respectively).  Per the Consolidation Orders of the United States Judicial Panel on Multidistrict Litigation, both of EDF’s August 11 petitions have now been consolidated with other petitions for review of the same orders.  Case No. 17-2464 was moved to the Fourth Circuit, and Case No. 2403 was moved to the Ninth Circuit. 

In the Fourth Circuit, the opening brief, record from agency, and the appendix are due September 20, 2017, and the response brief is due October 20, 2017.  In the Ninth Circuit, the Petitioners’ briefs are due October 30, 2017, and Respondent EPA’s briefs are due November 28, 2017.                                       


 
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By Lynn L. Bergeson and Carla N. Hutton

On August 17, 2017, the U.S. Environmental Protection Agency (EPA) submitted a proposed rule regarding reporting requirements for a mercury inventory to the Office of Management and Budget (OMB).  The proposed rule would establish reporting deadline(s) and information requirements for the purpose of assisting EPA’s periodic update and publication of the inventory of mercury supply, use, and trade in the U.S.  As required under the Frank R. Lautenberg Chemical Safety for the 21st Century Act, EPA must “carry out and publish in the Federal Register an inventory of mercury supply, use, and trade” in the U.S.  The Lautenberg Act defines mercury as “elemental mercury” or “a mercury compound.”  The inventory was to be published no later than April 1, 2017, and every three years thereafter, as supported by a rule authorized in the Lautenberg Act.  As reported in our March 29, 2017, blog item, EPA published an initial inventory report on March 29, 2017.  For subsequent inventories, EPA is authorized to promulgate a rule to “assist in the preparation of the inventory” so that “any person who manufactures mercury or mercury-added products or otherwise intentionally uses mercury in a manufacturing process shall make periodic reports to the Administrator, at such time and including such information as the Administrator shall determine.”  EPA expects future triennial inventories of mercury supply, use, and trade to include data collected directly from such persons.  In future inventories, EPA also will “identify any manufacturing processes or products that intentionally add mercury; and . . . recommend actions, including proposed revisions of Federal law or regulations, to achieve further reductions in mercury use.”  EPA must promulgate a final rule by June 22, 2018.


 
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By Lynn L. Bergeson and Carla N. Hutton

On September 6, 2017, at 10:00 a.m. (EDT), the House Science, Space, and Technology Subcommittees on Environment and on Oversight will hold a joint hearing on “Examining the Scientific and Operational Integrity of EPA’s IRIS Program.”  The following witnesses are scheduled to testify:

  • Dr. Kenneth Mundt, Principal, Ramboll Environ;
  • Dr. James Bus, Senior Managing Scientist, Exponent; and
  • Dr. Thomas Burke, former Deputy Assistant Administrator of the U.S. Environmental Protection Agency’s (EPA) Office of Research and Development (ORD) and EPA’s Science Advisor under former President Obama; Johns Hopkins University.

President Trump’s proposed budget request for fiscal year 2018 would have eliminated EPA’s Integrated Risk Information System (IRIS) Program, although the IRIS Program is included in the final budget request.  The EPA Science Advisory Board’s (SAB) August 29-30, 2017, meeting included an update from ORD’s National Center for Environmental Assessment on the IRIS Program.  According to the presentation, IRIS is working to increase transparency and full implementation of systematic review; modernize the IRIS Program; modularize product lines; and enhance accessibility.  Other IRIS improvements include implementing “next generation IRIS” and improved management practices.  During the meeting, the SAB agreed to send a letter to EPA Administrator Scott Pruitt in support of the IRIS Program.

Tags: IRIS, SAB, Hearing,

 
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By Lynn L. Bergeson and Carla N. Hutton

As reported in our August 25, 2017, blog item, the U.S. Environmental Protection Agency (EPA) will hold a webinar on September 7, 2017, on its process for gathering use and exposure information on five persistent, bioaccumulative, and toxic (PBT) chemicals under the amended Toxic Substances Control Act (TSCA).  EPA will provide background on new requirements for regulating certain PBT chemicals and explain how interested parties can provide use information to EPA on these five chemicals:

  • Decabromodiphenyl ethers (DecaBDE), used as a flame retardant in textiles, plastics, wiring insulation, and building and construction materials;
  • Hexachlorobutadiene (HCBD), used as a solvent in the manufacture of rubber compounds and as hydraulic, heat transfer, or transformer fluid;
  • Pentachlorothiophenol (PCTP), used as a mercaptan (sulfur) cross-linking agent to make rubber more pliable in industrial uses;
  • Phenol, isopropylated, phosphate (3:1), used as a flame retardant in consumer products and as lubricant, hydraulic fluid, and other industrial uses; and
  • 2,4,6-Tris(tert-butyl) phenol, an antioxidant that can be used as a fuel, oil, gasoline, or lubricant additive.

Due to significant interest in the webinar, EPA is requesting information from participants who would like to offer public input following the EPA presentation, in an effort to accommodate as many commenters as possible.  If you would like to speak following the presentation, please send an e-mail to .(JavaScript must be enabled to view this email address) by Tuesday, September 5, 2017, that includes the following information:

  • Your name;
  • The organization you represent; and
  • The PBT chemical on which you will speak.

EPA has established public dockets for each of the chemicals to facilitate receipt of information on exposure and use that may be useful to EPA’s rulemaking effort.  EPA requests that any information be submitted to the dockets by December 9, 2017, so that the information can inform any regulatory action.


 
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By Lynn L. Bergeson and Carla N. Hutton

The U.S. Environmental Protection Agency (EPA) will hold a September 7, 2017, webinar to explain its process for gathering use and exposure information on five persistent, bioaccumulative, and toxic (PBT) chemicals under the amended Toxic Substances Control Act (TSCA).  EPA states that the webinar will provide background on new requirements for regulating certain PBT chemicals and explain how interested parties can provide use information to EPA on these five chemicals:

  • Decabromodiphenyl ethers (DecaBDE), used as a flame retardant in textiles, plastics, wiring insulation, and building and construction materials;
  • Hexachlorobutadiene (HCBD), used as a solvent in the manufacture of rubber compounds and as hydraulic, heat transfer, or transformer fluid;
  • Pentachlorothiophenol (PCTP), used as a mercaptan (sulfur) cross-linking agent to make rubber more pliable in industrial uses;
  • Phenol, isopropylated, phosphate (3:1), used as a flame retardant in consumer products and as lubricant, hydraulic fluid, and other industrial uses; and
  • 2,4,6-Tris(tert-butyl) phenol, an antioxidant that can be used as a fuel, oil, gasoline, or lubricant additive.

Under TSCA Section 6(h), EPA is required to take expedited regulatory action to address risks and exposures from certain PBT chemicals.  By June 22, 2019, EPA must propose rules for the above five PBT chemicals that have been identified under TSCA Section 6(h)(1).  EPA is currently identifying where these chemicals are used and how people are exposed to them.  Following EPA’s presentation, participants will have an opportunity to provide their comments on uses of these five chemicals.


 
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By Lynn L. Bergeson and Carla N. Hutton

On August 22, 2017, the U.S. Environmental Protection Agency (EPA) Office of Inspector General (OIG) announced that it plans to begin preliminary research to assess Chemical Data Reporting (CDR) under the Toxic Substances Control Act (TSCA).  According to OIG’s Project Notification, the specific objectives for this evaluation are to determine:  (1) how EPA is ensuring that companies are compliant with CDR requirements under TSCA; and (2) whether EPA is using CDR data to prioritize imported and manufactured chemicals for the purpose of identifying the potential for human health and environmental risks.  The Project Notification asks Wendy Cleland-Hamnett, Acting Assistant Administrator for the Office of Chemical Safety and Pollution Prevention, and Lawrence Starfield, Acting Assistant Administrator for the Office of Enforcement and Compliance Assurance, to provide the following information:

  • Policies, procedures, and guidance on how CDR data are used in the prioritization of chemicals for TSCA risk evaluations and/or other assessments;
  • Policies, procedures, and guidance regarding the quality assurance/quality control of CDR data; and
  • Enforcement response policy and guidance for CDR violations.

The Project Notification states that the anticipated benefits of the project are “reduced risks to human health and the environment from the monitoring and oversight of TSCA chemicals subject to the CDR rule reporting requirements.”


 
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By Lynn L. Bergeson and Margaret R. Graham

On August 18, 2017, the U.S. Environmental Protection Agency (EPA) announced that it would be holding a public workshop on the use of the paint remover methylene chloride in furniture refinishing on September 12, 2017, from 9:00 a.m. to 4:00 p.m. (EDT) at its Region 1 Headquarters in Boston, Massachusetts.  It is holding the workshop in collaboration with the Small Business Administration (SBA) Office of Advocacy.  The meeting aims to “facilitate an exchange of information on existing use practices and furniture refinishers’ experience, in general, with paint removal products and methods.”

EPA’s January 19, 2017, proposed rule proposed to prohibit the manufacture (including import), processing, and distribution in commerce of methylene chloride for consumer and most types of commercial paint and coating removal under Section 6 of the Toxic Substances Control Act (TSCA).  EPA states that this workshop will allow “[f]ederal and state governments, industry professionals, furniture refinishing experts, non-government organizations, and academic experts, among others, [to] discuss the role of methylene chloride in furniture refinishing, potential alternatives, economic impacts, and other issues identified in EPA’s January 2017 proposed rule on methylene chloride,” and information learned from this workshop will allow it to “better understand current work practices and obtain additional information on the economic considerations involved in selecting chemical products for paint and coating removal in the furniture refinishing sector.”

EPA will open a docket at www.regulations.gov in Docket ID EPA-HQ-OPPT-2017-0139 upon publication of the notice of the meeting in the Federal Register, and will be accepting comments until November 12, 2017Registration for the meeting is available online.  Registrants can choose to attend in-person, via webinar, or via phone.

 

 


 
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By Lynn L. Bergeson and Margaret R. Graham

On August 18, 2017, the U.S. Environmental Protection Agency (EPA) is scheduled to publish a notice in the Federal Register stating that it will be holding the third and fourth committee meetings of the Negotiated Rulemaking Committee (NRC) on September 13, 2017, from 9:00 a.m to 5:00 p.m. (EDT) to September 14, 2017, from 9:00 a.m to 3:00 p.m. (EDT); and on October 25, 2017, from 9:00 a.m. to 5:00 p.m. (EDT) to October 26, 2017, from 9:00 a.m. to 3:00 p.m. (EDT).  The third meeting will take place at the Ronald Reagan Building and International Trade Center, Oceanic Suite, 1300 Pennsylvania Avenue N.W., Washington, D.C. 20004, while the fourth meeting will be held at the William Jefferson Clinton East Building, Room 1153, 1201 Constitution Avenue N.W., Washington, D.C. 20004.  Both meetings are open to the public.

The NRC’s objective is to “negotiate a proposed rule that would limit chemical data reporting requirements under Section 8(a) of the Toxic Substances Control Act (TSCA), [as amended], for manufacturers of any inorganic byproduct chemical substances when such byproduct chemical substances are subsequently recycled, reused, or reprocessed.”  Kathleen M. Roberts, Vice President of B&C® Consortia Management, L.L.C. (BCCM), an affiliate of Bergeson & Campbell, P.C. (B&C®), is on the NRC on behalf of a BCCM client.  EPA states that written comments can be submitted at any time during the negotiated rulemaking process, but is asking for written comments to be e-mailed to .(JavaScript must be enabled to view this email address) no later than one week prior to the meeting dates (September 6, 2017; and October 19, 2017).  Information about attending these meetings and their agendas will be posted to the NRC website.   More information regarding the NRC is available on our blog under key phrase Negotiated Rulemaking


 
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By Lynn L. Bergeson

On August 14, 2017, Bergeson & Campbell, P.C. (B&C®) announced it would be forming a Toxic Substances Control Act (TSCA) New Chemicals Coalition.  That the U.S. Environmental Protection Agency (EPA) is now required to make a determination on all new chemicals (or significant new uses of existing chemicals) is at the heart of the changes in EPA’s review of new chemicals, and the new policies and practices that have emerged since June of 2016.  What is less clear is how EPA is making these determinations.  The coalition’s mission is to prepare meaningful comments and offer constructive, helpful, and informed improvements to the new chemicals review process. 

Joining the coalition is easy.  We are asking for a flat fee of $1,000 per company for a 12 month period.  We are not currently allowing trade associations to join.  The chemical community has participated in ad hoc coalitions for years, so the drill is familiar.  Dues will be used to:

  • Convene meetings and calls;
  • Develop advocacy positions on crucial issues to be decided and prioritized, including preparing for EPA’s Fall 2017 release of documents on how it reviews new chemicals; and
  • Provide informed and effective comment on these issues and meet with EPA leadership to advocate for the Coalition’s views on these issues.

More information is available in our memorandum Bergeson & Campbell, P.C. Forms “TSCA New Chemicals Coalition.”


 
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By Lynn L. Bergeson and Carla N. Hutton

On August 14, 2017, as the final Toxic Substances Control Act (TSCA) Section 8(a) information gathering rule on nanomaterials took effect, the U.S. Environmental Protection Agency (EPA) published “working guidance” intended to assist stakeholders in complying with the rule.  The working guidance notes that it “will not provide answers to all of the potential questions that will arise as manufacturers and processors seek to comply with the rule.  Commenters to the draft guidance asked several questions that would require more details or information before EPA could respond to their question.”  If the guidance does not answer questions about the rule, companies are directed to contact Jim Alwood, Chemical Control Division, Office of Pollution Prevention and Toxics, .(JavaScript must be enabled to view this email address).  EPA states that it will answer questions on a case-by-case basis.  EPA intends to add further questions/answers and revisions to the guidance based on questions identified by persons who may be subject to the rule. 

As reported in our January 11, 2017, blog item, the January 12, 2017, final rule establishes reporting and recordkeeping requirements for certain discrete forms of chemical substances that are manufactured or processed at the nanoscale.  Under the rule, manufacturers and processers, or persons who intend to manufacture or process these chemical substances must report certain information to EPA.  The information to be reported includes, insofar as known to or reasonably ascertainable by the person making the report, the specific chemical identity, production volume, methods of manufacture and processing, exposure and release information, and existing information concerning environmental and health effects.  Persons who manufacture or process a discrete form of a reportable chemical substance at any time during the three years prior to August 14, 2017, the effective date of the final rule, must report to EPA one year after the effective date of the final rule.  There is also a standing one-time reporting requirement for persons who intend to manufacture or process a discrete form of a reportable chemical substance on or after the effective date of the rule.  These persons must report to EPA at least 135 days before manufacture or processing of that discrete form.  More information regarding the final rule is available in our January 12, 2017, memorandum EPA Promulgates Final TSCA Reporting and Recordkeeping Rule for Nanoscale Materials.


 
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