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

By Richard E. Engler, Ph.D. and Margaret R. Graham

On May 17, 2018, the U.S. Environmental Protection Agency (EPA) issued a notice releasing statements of findings on new chemical substances made on Toxic Substances Control Act (TSCA) Section 5(a) notices during the period from February 1, 2018, to March 31, 2018.  83 Fed. Reg. 22978.  EPA is required to do so per TSCA Section 5(g) after its review of TSCA Section 5(a) notices when it 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.  EPA posted these determinations on its website when they were made.  The statements of findings, all related to premanufacture notices (PMN), and their website links are:

  • EPA Case Number:  P-16-0415; chemical name:  generic:  polyurethane; polymer exemption flag (generic name); intended uses:  coating for oil and gas industry; known and reasonably foreseen use(s):  paint additive and coating additive. 
  • EPA Case Number:  P-18-0002; chemical name:  generic:  phosphinic acid, P,P-alkyl-, salt (generic name); intended use(s) (specific):  chemical intermediate for a non-halogenated flame retardant; known and reasonably foreseen use(s):  chemical intermediate; flame retardant. 
  • EPA Case Number:  P-18-0021; chemical name:  generic: dicarboxylic acids, polymers with substituted poly (substituted alkendiyl), 3-hydroxy-2-(hydroxyalkyl)-2-alkylalkenoic acid, 5-substituted-1-(substituted alkyl)-1,3,3-trialkyl carbomonocyle, alkanediol, alkane-triol, alcohol blocked compounds with aminoalcohol; polymer exemption flag (generic name); intended use(s) (generic):  paint; known and reasonably foreseen use(s):  adhesive and sealant chemical.
  • EPA Case Numbers:  P-18-0044 - 0045:
    • P-18-0044:  chemical name:  generic:  fatty acids (generic name); intended use(s) (generic):  intermediate species known and reasonably foreseen use(s):  chemical intermediate; lubricant and lubricant additive; viscosity adjustor; coating.
    • P-18-0045:  chemical name:  generic:  fatty acids, alkyl esters; intended use(s) (generic):  application coating; known and reasonably foreseen use(s):  lubricant intermediate; mold release agent; plasticizer; processing aid.
  • EPA Case Number:  P-18-0083; chemical name:  specific:  2-propenoic acid, telomers with bualc.-2-[(2-propen-1-yloxy)methyl]oxirane reaction products, sodium bisulfite and sodium 2-hydroxy-3-(2-propen-1-yloxy)-1-propanesulfonate(1:1), sodium salts, peroxydisulfuric acid([(HO)S(O)2]2O2) sodium salt (1:2)-initiated. (CASRN: 2118944-42-4); intended use(s) (generic):  dispersant additive; known and reasonably foreseen use(s):  chelating agent.

Commentary

P-18-0044, P-18-0045, and P-18-0083 are notable in that EPA identified a hazard other than “low hazard” for health or the environment and nevertheless concluded that exposures were low enough that the substances are not likely to present an unreasonable risk under the reasonably foreseeable conditions of use.  In the cases of P-18-0044 and P-18-0045, EPA identified health hazards, but EPA expects that exposures to the general population will be low and that there will not be consumer uses.  Furthermore, EPA expects that workers will “use adequate personal protective equipment.”  In the case of P-18-0083, EPA identified acute and chronic aquatic toxicity concentrations of concern of >20,000 and >1,000 parts per billion, respectively.  Even though these do not meet EPA’s thresholds for “low hazard,” EPA does not expect releases to exceed those thresholds.

More information on TSCA’s implementation is available on our TSCA Reform News & Information web page. 


 

By Charles M. Auer and Richard E. Engler, Ph.D.

The U.S. Environmental Protection Agency’s (EPA) Office of Pollution Prevention and Toxics (OPPT or the Office) has decided to delay its pending reorganization to take and consider staff comments on the revised reorganization.  The new plan proposes a six division structure that has separate new and existing chemical risk management divisions complemented by separate new and existing chemical risk assessment divisions.  OPPT’s other functions are proposed to be distributed into a mission operations division and a division that sweeps together chemical right-to-know, economics, information reporting, and the Safer Choice/Design for the Environment (DfE) program.  In an internal memo, OPPT Director Jeffery Morris, Ph.D., noting the thoughtful and insightful staff comments received on the earlier proposed reorganization, provides a two-week internal commenting period for the new proposal ending on May 9, 2018.

How to organize OPPT has been a perpetual conundrum with shifting “best approaches” over time.  From our perspective, merging the existing chemicals function of the Chemical Control Division (CCD) with those of the National Program Chemicals Division (NPCD) into an Existing Chemicals Management Division makes sense.  The existing NPCD branches that cover legacy chemical issues (e.g., lead, polychlorinated biphenyls (PCB), mercury, and asbestos) will presumably become risk management branches tasked with overseeing risk management activities for those chemicals under the amended Toxic Substances Control Act (TSCA or new TSCA).  The other “first ten” risk evaluation chemicals that are currently being managed by the existing chemicals staff in CCD will become other risk management branches in the new structure.  Creating a separate New Chemicals Management Division also makes sense in light of the challenges encountered by the office in its early implementation of Section 5 under new TSCA.  Such a division will ensure a tight management focus on new chemicals issues without the need to also juggle complex existing chemicals issues.  While this could present concerns regarding divergent decisions and policies between the two divisions, this seems to be less of an issue since the requirements in Sections 5 and 6 differ so much.

More information and commentary on this reorganization is available in our memorandum.


 

By Lynn L. Bergeson and Margaret R. Graham

On March 6, 2018, in the U.S. Court of Appeals for the D.C. Circuit, the Environmental Defense Fund (EDF) filed its Principal Brief in the litigation case that petitions for review the U.S. Environmental Protection Agency’s (EPA) Toxic Substances Control Act (TSCA) Inventory Notification (Active-Inactive) Requirements final rule (EDF v. EPA, No. 1701 (D.C. Cir.)).

EDF’s brief includes, among other required statements, a statement of the issues, a statement of the case, a summary of their argument, and their argument.  EDF’s arguments are as follows:

  1. The Inventory Rule withholds information on chemical substances manufactured or processed in the U.S. from the public; this information is required to be disclosed under amended TSCA; EDF has been harmed by EPA’s failure to disclose this information and to disclose unique identifiers for confidential chemicals; and the court can redress this harm.  
  2. The final rule illegally allows manufacturers and processors to assert certain new claims for nondisclosure of specific chemical identities based on other persons having asserted earlier claims, which is contrary to TSCA’s plain text and the relevant precedent governing confidentiality claims; and EPA’s rationale for its interpretation is arbitrary and capricious.
  3. The final rule violates both the substantive and procedural requirements of TSCA Section 14, Confidential Information, specifically that:  EPA refused to accept that TSCA Section 8, Reporting and Retention of Information, repeatedly incorporates Section 14 requirements for confidentiality claims; the final rule fails to implement one of the substantive requirements for confidentiality claims under Section 14; and the final rule fails to implement one of the substantive requirements for confidentiality claims under Section 14.
  4. The final rule fails to implement the unique identifier and other public information requirements in TSCA Section 8(b)(7)(B).
  5. The final rule exempts chemicals manufactured and processed solely for export from the reporting requirements, even though such chemicals are specifically not exempted from TSCA Section 8.
  6. Finally, EDF requests the court to set aside the rule in part, stating that vacatur, along with remand, is the appropriate remedy for EPA’s violations of the Administrative Procedure Act (APA).  EDF does not seek a complete vacatur, however, stating that “a complete vacatur would postpone the release of some of the very information that EDF seeks, since it would allow EPA to postpone publishing the Inventory based on the information it has already collected.  In addition, it would impose costs on the regulated community beyond those necessary to remedy EDF’s harms [and] those manufacturers and processors who have already filed notices without claims of confidentiality should not need to refile the notices.”  The portions of the final rule that EDF requests the court to vacate are as follows:  the exclusion for export-only manufacturers (40 C.F.R. Section 710.27(a)(4)); Confidentiality Claims (40 C.F.R. Section 710.37); and certain portions of the preamble. EDF states specific instructions on how it would like the court to order EPA to promulgate the regulation on remand that include revisions to regulations on confidentiality claims, public information requirements, and notifications of activities during the lookback period.

EDF has done its usual thorough job and the brief is definitely a must read for TSCA stakeholders.  More information on this proceeding and the other challenges to the TSCA framework final rules is available on our blog under key words framework rules.


 

By Lynn L. Bergeson, Susan M. Kirsch, and Margaret R. Graham

On January 30, 2018, the Senate Committee on Environment and Public Works (EPW) convened an Oversight Hearing to Receive Testimony from U.S. Environmental Protection Agency (EPA) Administrator Scott Pruitt.  In a written statement submitted in advance of the hearing, Pruitt described implementation of the new Frank R. Lautenberg Chemical Safety for the 21st Century Act, or the “new” Toxic Substances Control Act (TSCA), as being of “significant importance” and a “top priority for ensuring the safety of chemicals in the marketplace.”  In opening remarks, Senator Tom Carper (Ranking Member of the EPW Committee) (D-DE)) challenged Pruitt’s record on implementing TSCA reform, stating that EPA has not truly used the authority bestowed on it through TSCA to declare that products being sold on the market are safe, therefore, consumers do not have the confidence that they deserve and that Congress intended in passing TSCA.  Pruitt did not respond to this comment, and did not go on to address TSCA implementation in his brief opening remarks.  Instead, Pruitt devoted the bulk of his opening statement to highlighting specific areas where EPA’s environmental protection goals dovetail well with opportunities for economic growth.  These issues/economic opportunities included:  investment in infrastructure to eradicate lead from drinking water within a decade; advancing initiatives that incentivize private companies to take on clean-up projects at abandoned mines; and remediation activities at “Superfund” sites -- hazardous waste sites regulated under the  Comprehensive Environmental Response, Compensation and Liability Act (CERCLA).

Senator Jeff Merkley (D-OR) expressed concern that EPA’s chemical reviews under TSCA were only focusing on new “items” (chemicals) being made, but overlooking “legacy” chemicals already in the environment (e.g., asbestos).  Merkley cited a report that claimed that review of the ten chemicals on the priority list were being “slow-walked.”  In response, Pruitt stated “it is an absolute priority during [EPA’s] first year,” the three TSCA final rules were issued consistent with the implementation schedule in the first year, and the backlog of chemical reviews has been addressed through the addition of resources. 

Senator Kirsten Gillibrand (D-NY) expressed her concerns regarding the toxic levels of perfluorooctanesulfonic acid (PFOS) and perfluorooctanoic acid (PFOA) that have been found throughout New York State, stating that EPA was not using its TSCA authority to regulate these chemicals, as the implementation final rules “ignored the public’s exposure to the past uses of chemicals called legacy uses” that could still have the potential to contaminate groundwater.  She also stated her concern that due to this oversight, EPA will not likely study the health risks of widespread exposure to chemicals such as PFOS/PFOS.  She requested of Pruitt to revise the TSCA implementation rules to address legacy issues, so that “all uses of a chemical, including legacy uses, are studied.”  Pruitt stated that as PFOA and PFOS have not been manufactured since early 2000, they are in fact legacy uses, and that EPA was “very much going to focus” on this issue.  Gillibrand appeared to be content with his answer, as she did not demand a further commitment from him.  In regards to the Hudson River, Gillibrand requested that data from the sediment sampling be integrated into EPA’s five year review plan regarding the effectiveness of dredging for removing polychlorinated biphenyl (PCB) from the Hudson River.  Pruitt stated that EPA was reviewing the samples currently and that there is more work to be done to get clarity on this issue.  Gillibrand requested Pruitt to personally review the final report to ensure that all issues have been addressed and Pruitt confirmed that he would.

Near the close of the hearing, Senator Carper further stated that EPA has failed to follow through on its proposed ban of three highly toxic chemicals that Congress gave it the authority to ban when it enacted TSCA reform:  specifically methylene chloride, tricholoroethylene (TCE), and methylpyrrolidone (NMP), and asked Pruitt to commit to using EPA’s authority to ban them within the next 30 days.  Pruitt responded that they are on the priority list and that he will confirm this with the agency (that they are priorities, not that they will be banned in 30 days).  EPA’s delay in finalizing the bans was among the failures cited in the Senate EPW Minority Staff report, released January 29, 2018, “Basically Backward:  How the Trump Administration is Erasing Decades of Air, Water and Land Protections and Jeopardizing Public Health.”

Several Senators indicated their intention to submit additional questions for the record.  Pruitt has until February 13, 2018, to submit written responses, which will be made available on the EPW Committee website.  The full hearing is available on the EPW Committee’s website.  


 

By Lynn L. Bergeson

Bergeson & Campbell, P.C.’s (B&C®) much anticipated and highly acclaimed annual Forecast, "Predictions and Outlook for U.S. Federal and International Chemical Regulatory Policy 2018," is now available.  In the Forecast, the lawyers, scientists, and chemical regulatory specialists at B&C and its affiliated consulting firm, The Acta Group (Acta®), offer comprehensive and highly useful observations on the fast-changing and nuanced area of domestic and global chemical legal, scientific, and regulatory issues expected to be hot topics in 2018.  This 38-page document is chock-full of insights, predictions, and useful information.

Happy New Year and enjoy reading our predictions!


 

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

On December 6, 2017, the U.S. Environmental Protection Agency’s (EPA) Office of Pollution Prevention and Toxics (OPPT) convened a much anticipated public meeting on implementing changes to the new chemicals review program under the amended Toxic Substances Control Act (TSCA).  EPA offered brief prepared remarks and previously solicited questions from stakeholders.  Stakeholders expressed their appreciation to EPA for developing the draft Points to Consider and related documents made available in advance of the meeting, and for OPPT’s continuing interest on new chemical issues.  For more information, see our blog “EPA Posts Agenda and Other Meeting Materials for December 6, 2017, New Chemicals Review Program Implementation Meeting.”  Below are some key takeaways regarding the meeting as related to EPA’s presentations and input from industry and non-governmental organizations (NGO).

Conditions of Use, SNURs, and PMNs:  EPA stated that one of its main concerns is when EPA does not identify unreasonable risk for intended use, but nonetheless has concerns with reasonably foreseen conditions of use. EPA stated that it will assess whether those concerns can be addressed through significant new use rules (SNUR) that it would promulgate prior to making its Section 5 finding.  EPA stated that, in identifying reasonably foreseeable uses, it will rely on knowledge, experience, and facts to support what is foreseen, not simply what is possible.  Several commenters requested clarification and examples on the information that will support such identifications.  This is plainly an area of intense interest and on which EPA pledged to clarify.

EPA confirmed that the SNUR would mirror the premanufacture notice (PMN) in a way that would clearly state what deviations would be permitted to ensure protections for portions of the PMN about which EPA had identified concerns.  In response to a direct question, Jeff Morris, Ph.D., OPPT Director, confirmed that he personally is looking at each new chemical notification decision to ensure a consistent and coherent approach to chemical reviews.  Dr. Morris assured stakeholders that his engagement would not slow down the PMN review process.

NGO groups, that were ably represented at the meeting, expressed disappointment that they were not a part of the pilot testing component of the new chemicals Points to Consider document. OPPT clarified that the purpose of the pilot was to have parties who are actually preparing PMNs pilot use of the document while preparing PMNs and that as a result, non-PMN submitters were not a part of the pilot.  Following a request from several NGOs, EPA stated that it would of course make the original and redline versions of the Points to Consider document publicly available to ensure full transparency.  Several NGOs also voiced concern with the delay of EPA getting PMN information posted online.  Commenters noted the need for access to more content related to the new chemicals review, such as detailed PMN determinations, as the determinations that are publicly available at this point are boilerplate. Interestingly, concerns were expressed on issues not germane to the workshop, such as existing and accidental releases of chemicals (not related to TSCA).

Of the parties that weighed in on the issue, industry representatives who addressed the issue were supportive of using SNURs to cover reasonably foreseeable conditions of use that are not reflected in the submitted PMNs.  Some NGOs were supportive of the use of SNURs to reduce consent orders, while others stated that SNURs are not an adequate substitute for consent orders and that Congress intended for Section 5(e) orders to come first and to trigger SNURs.  The concern over the use of SNURs rather than consent orders may relate to a concern of chemicals being introduced prior to the SNUR being published in final.  Industry representatives also suggested that EPA seek to scale its information needs appropriately.  For instance, less detailed exposure information should be required for EPA to determine that it has sufficient information on a low hazard chemical.  Similarly, EPA should adjust the hazard profile requirements for a chemical with low exposure.

Chemical Categories:  EPA reviewed the ongoing effort to develop four new chemical categories that could be used in future new chemical reviews.  These are:

  1. Lung Effects Categories:  Polycationic substances (cationic binding); general surfactants; waterproofing agents; and insoluble polymer lung overload;
  2. Photo-Acid Generators (PAG) Category;
  3. Tracer Chemical; and
  4. Perfluorinated Chemicals.

EPA asked for input and ideas on how to move forward with chemical categories -- either by updating existing categories or reviewing internal data to identify new categories -- and how the information should be presented (e.g., to publish separately or together in one document).

OSHA Focus:  On behalf of the TSCA New Chemicals Coalition (TSCA NCC), Richard E. Engler, Ph.D., Bergeson & Campbell, P.C., provided comments that included feedback to EPA that it needs to develop a consultation process with the U.S. Occupational Safety and Health Administration (OSHA) per the Section 5(f) legislative language.  Dr. Engler suggested that EPA’s assessments could be communicated to submitters and OSHA to inform both on the endpoints of concern and EPA’s assessments of safe exposure limits.  In this way, employers are obligated under the Occupational Safety and Health Act to assess hazards and exposures, provide information to workers, and ensure that exposures are controlled under OSHA’s authority, thereby satisfying EPA’s obligation to regulate “to the extent necessary” to protect such workers.

Sustainable Futures Program:  EPA asked for input as to whether it should continue the Sustainable Futures Program.  Some commenters supported the Sustainable Futures Program; no commenters spoke against it.

The presentations from the meeting are listed below and available online:

EPA’s next public meeting on TSCA’s implementation of Existing Chemicals Prioritization is coming up on December 11, 2017.  More information on this upcoming meeting is available on our blog under key phrase public meeting.


 

By Lynn L. Bergeson and Margaret R. Graham

On November 9, 2017, the U.S. Environmental Protection Agency (EPA) released the agenda and meeting materials for its December 6, 2017, New Chemicals Review Program Implementation meeting.  NOTE WELL: This is a critically important meeting for companies that innovate in the chemical space and are now preparing Toxic Substance Control Act (TSCA) Premanufacture Notifications (PMN) or will in the future.  EPA states that this meeting will update and engage with the public on EPA’s progress in implementing changes to the New Chemicals Review Program as a result of the 2016 amendments to TSCA, and will include a discussion of EPA’s draft New Chemicals Decision-Making Framework.  The meeting materials include:

  • Agenda for Public Meeting.  The Agenda includes the following topics: the decision-making framework; TSCA orders and Significant New Use Rules (SNUR) in the context of new chemicals review; the Points to Consider document as well as the pilot results and other questions; the decision guidelines manual; chemical categories; sustainable futures; a discussion of questions submitted in advance; and two public comment periods.  Featured speakers are Nancy Beck, Ph.D., Deputy Assistant Administrator for the Office of Chemical Safety and Pollution Prevention (OSCPP) and Jeff Morris, Ph.D., Director of the Office of Pollution Prevention and Toxics (OPPT).
  • New Chemicals Decision-Making Framework:  Working Approach to Making Determinations under Section 5 of TSCA.  EPA states that this document includes EPA’s general decision framework for new chemicals and a breakdown of how EPA intends to approach each of the five types of new-chemical determinations required.
  • Points to Consider When Preparing TSCA New Chemical Notifications (Draft).  This draft document, dated November 6, 2017, provides concise information to assist submitters in preparing a PMN, Significant New Use Notice (SNUN), or exemption notice (e.g., Low Volume Exemption or LVE) that (1) meets the requirements of TSCA Section 5 and applicable regulations; and (2) facilitates EPA’s review of Section 5 notices by ensuring that the information received accurately and completely reflects the intended manufacture, processing, distribution in commerce, use, and disposal of the new chemical substances subject to the Section 5 notice.  EPA states this is a draft published for comment, but does not specify a deadline for submitting comments.
  • Overview of Comments Received on the Draft "Points to Consider" Document.  This document summarizes 151 comments received on the draft Points to Consider document.  It organizes them by topic.  The topics addressed are aquatic haz/tox; chemistry; data; engineering; environmental release and disposal information; fate; a general category; human health haz/tox; regulatory; release to water; standard review; uses; risk; exposure; and prenotice meetings.  These comments have not been posted in the docket for this meeting.
  • New Chemicals Decision Guidelines Manual – Detailed Outline.  EPA states that this manual will summarize how EPA reviews new chemical submissions and the policies and decision guidelines used in making decisions under TSCA Section 5.  It will provide an overview of both risk assessment and risk management approaches. Further, it is intended to help stakeholders determine what forms of regulation and restrictions on the manufacture, distribution, use, and/or disposal of a new chemical substance may arise from an EPA determination.

The December 6, 2017, meeting will take place from 9:00 a.m. to 5:00 p.m. (EST) at the Ronald Reagan Building and International Trade Center, Horizon Ballroom, 1300 Pennsylvania Avenue, N.W., in Washington, D.C., and will be available by remote access for registered participants.  Online requests to participate must be received on or before December 5, 2017.  EPA states it plans to utilize the feedback it receives from the public meeting and comments received to improve policy and processes relating to the review of new chemicals under TSCA.  EPA will be accepting questions from the public in advance of the meeting, and will respond to these questions at the meeting as time allows, if such questions are received by November 20, 2017.  Questions and comments can be submitted in Docket No. EPA-HQ-OPPT-2017-0585 on www.regulations.gov with a copy to .(JavaScript must be enabled to view this email address)Registration for this meeting is available online.  In addition to hearing oral comments at the meeting, EPA is also accepting written comments and materials submitted to the docket for this meeting until January 20, 2018.

More information on the subsequent Approaches for Identifying Potential Candidates for Prioritization for Existing Chemical Risk Evaluations meeting on December 11, 2017, is available in our blog item EPA Schedules Two Meetings to Discuss TSCA Implementation Activities, Requests Comments.


 

By Lynn L. Bergeson and Margaret R. Graham

On November 6, 2017, the U.S. Environmental Protection Agency (EPA) is scheduled to publish a notice in the Federal Register in which it will announce two meetings to discuss implementation activities under the Toxic Substances Control Act (TSCA) as amended by the Frank R. Lautenberg Chemical Safety for the 20th Century Act, as well as request public comments.  The meetings are:

  • New Chemicals Review Program Implementation Meeting:  December 6, 2017, from 9:00 a.m. to 5:00 p.m. (EST).  EPA’s first meeting will update and engage with the public on EPA’s progress in implementing changes to the New Chemicals Review Program as a result of the 2016 amendments to TSCA, and will include a discussion of EPA’s draft New Chemicals Decision-Making Framework.  EPA will describe its review process for new chemical substances under the amended statute and interested parties will have the opportunity to provide input and to ask questions.  EPA states it plans to utilize the feedback it receives from the public meeting and comments received to improve policy and processes relating to the review of new chemicals under TSCA.  EPA will be accepting questions from the public in advance of the meeting, and will respond to these questions at the meeting as time allows, if such questions are received by November 20, 2017.  Questions and comments can be submitted in Docket No. EPA-HQ-OPPT-2017-0585 on www.regulations.govRegistration for this meeting is available online.
  • Approaches for Identifying Potential Candidates for Prioritization for Existing Chemical Risk Evaluations Meeting:  December 11, 2017, from 9:00 a.m. to 5:00 p.m. (EST).  EPA’s second meeting will focus on possible approaches for identifying potential candidate chemical substances for EPA’s prioritization process under TSCA.  As amended, TSCA required that EPA establish processes for prioritizing and evaluating risks from existing chemical substances.  EPA will describe and take comment on a number of possible approaches that could guide it in the identification of potential candidate chemical substances.  EPA will be accepting questions from the public in advance of the meeting, and will respond to these questions at the meeting as time allows, if such questions are received by November 20, 2017.  Questions and comments can be submitted in Docket No. EPA-HQ-OPPT-2017-0586 on www.regulations.govRegistration for this meeting is available online.

Online requests to participate in either meeting must be received on or before December 5, 2017.  Both meetings will be held at the Ronald Reagan Building and International Trade Center, Horizon Ballroom, 1300 Pennsylvania Avenue, N.W., in Washington, D.C., and will be available by remote access for registered participants. EPA states that more information on the specifics of the meetings will be made available in the dockets and on EPA’s website prior to the meeting.


 

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,

 

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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