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 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regarding review of EPA’s TSCA framework rule Procedures for Chemical Risk Evaluation under TSCA, the Fourth Circuit rescinded the briefing schedule.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.  


 

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.


 

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.                                       


 

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.


 

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


 

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.


 

By Lynn L. Bergeson and Margaret R. Graham

On August 11, 2017, the U.S. Environmental Protection Agency (EPA) published the third Toxic Substances Control Act (TSCA) framework final rule in the Federal Register, the TSCA Inventory Notification (Active-Inactive) Requirements.  This final rule is effective as of August 11, 2017 (the date of publication).

As further detailed in the final rulemaking, chemical manufacturers and importers are required to submit notifications for chemicals that were manufactured or imported over the ten year look-back period of June 21, 2006, to June 21, 2016.  Pursuant to the rulemaking, the retrospective reporting period for manufacturers begins on August 11, 2017, and ends on February 7, 2018.  The submission period for processors also begins on August 11, 2017, but processors have until October 5, 2018, to submit retrospective activity notifications.

More information on the final rule is available in our memorandum EPA Issues Final TSCA Framework Rules.


 

By Lynn L. Bergeson and Margaret R. Graham

On August 11, 2017, the U.S. Environmental Protection Agency (EPA) is scheduled to publish the third Toxic Substances Control Act (TSCA) framework final rule in the Federal Register, the TSCA Inventory Notification (Active-Inactive) Requirements.  This final rule is scheduled to become effective on August 11, 2017 (the date of publication).

This rule, signed by EPA on June 22, 2017, establishes, among other requirements:

  • A retrospective electronic notification of chemical substances on the TSCA Inventory that were manufactured (including imported) for nonexempt commercial purposes during the ten-year time period ending on June 21, 2016, with provision to also allow notification by processors;
  • Procedures for forward-looking electronic notification of chemical substances on the TSCA Inventory that are designated as inactive, if and when the manufacturing or processing of such chemical substances for nonexempt commercial purposes is expected to resume; and
  • Procedures regarding the manner in which such retrospective and forward-looking activity notifications must be submitted, the details of the notification requirements, exemptions from such requirements, and procedures for handling claims of confidentiality.

More information on this final rule is available in our memorandum EPA Issues Final TSCA Framework Rules.  


 

By Lynn L. Bergeson and Margaret R. Graham

On August 3, 2017, the U.S. Environmental Protection Agency (EPA) published a notice on further nominations to the Science Advisory Committee on Chemicals (SACC).  EPA’s notice provides the names and affiliations of 64 additional candidates currently under consideration for appointment to SACC.  Biographical sketches for these candidates will be are posted on EPA’s website

EPA will also be considering the 29 candidates for membership previously identified in the December 9, 2016, Federal Register notice -- their biographical sketches are available here.  EPA states that it “anticipates selecting approximately six additional SACC members with specific expertise and perspectives representing industry, labor, animal protection, government, public health, and public interest groups.”  EPA is inviting comments on the candidates to be used to assist in the selection process.  Comments are due September 5, 2017.

More information on these new nominations is available in our memorandum EPA Seeks Comment on Nominations to “Augmented” Science Advisory Committee on Chemicals.  More information on the SACC is available on our blog under key word SACC.


 

By Lynn L. Bergeson and Margaret R. Graham

On July 20, 2017, the Trump Administration released its 2017 Unified Regulatory Agenda.  The U.S. Environmental Protection Agency’s (EPA) Agency Rule List included many items under the Toxic Substances Control Act (TSCA), including six in the final rule stage, ten in the proposed rule stage, and one in the prerule stage.  The six items in the final rule stage are:

  1. RIN 2070-AK20:  Procedures for Evaluating Existing Chemical Risks Under the Toxic Substances Control Act.  This final rule has been issued in final and published in the Federal Register.  The effective date is September 18, 2017.  More information on this final rule is available in our memorandum EPA Issues Final TSCA Framework Rules.
  2. RIN 2070-AK23:  Procedures for Prioritization of Chemicals for Risk Evaluation Under the Toxic Substances Control Act.  This final rule has been issued in final and published in the Federal Register.  The effective date is September 18, 2017.  More information on this final rule is available in our memorandum EPA Issues Final TSCA Framework Rules.
  3. RIN 2070-AK24:  TSCA Inventory Notification Active-Inactive Reporting Requirements.  This rule has been issued in final but is still awaiting publication in the Federal Register.  The expected effective date is the date of publication.  More information on this final rule is available in our memorandum EPA Issues Final TSCA Framework Rules.
  4. RIN 2070-AJ54:  The Nanoscale Materials; Chemical Substances When Manufactured, Imported, or Processed as Nanoscale Materials; Reporting and Recordkeeping Requirements.  This final rule has been issued in final and published in the Federal Register.  The effective date listed in the Federal Register was May 12, 2017, but the effective date listed in the agenda is TBD.  More information on this final rule is available in our memorandum EPA Promulgates Final TSCA Reporting and Recordkeeping Rule for Nanoscale Materials
  5. RIN 2070-AJ91:  Significant New Use Rule for Toluene Diisocyanates (TDI) and Related Compounds.  The agenda states that EPA is developing a significant new use rule (SNUR) under Section 5(a)(2) of TSCA for 2,4-toluene diisocyanate, 2,6-toluene diisocyanate, toluene diisocyanate unspecified isomers and related compounds.  This rule is still awaiting issuance in final and publication in the Federal Register.  It was scheduled to be issued in June 2017.
  6. RIN 2070-AJ44:  Formaldehyde Emission Standards for Composite Wood Products.  The agenda states that this final rule implements the Formaldehyde Standards for Composite Wood Products Act, which added Title VI to TSCA, and its purpose is to reduce formaldehyde emissions from composite wood products.  This rule has been issued in final and published in the Federal Register.  Its effective date was delayed per a subsequent Federal Register notice to May 22, 2017, but is listed on the agenda as TBD.

The ten items in the proposed rule stage are:

  1. RIN 2070-AJ65:  Microorganisms: General Exemptions From Reporting Requirements; Revisions of Recipient Organisms Eligible for Tier I and Tier II Exemptions.  The agenda states that EPA is developing a revised proposal that will address concerns raised by commenters in response to its preliminary determination that certain strains of Trichoderma reesei and Bacillus amyloliquefaciens will not present an unreasonable risk of injury to health or the environment when used as a recipient microorganism, provided that certain criteria for the introduced genetic material and the physical containment conditions are met.  EPA is also considering expanding the earlier proposal to prohibit the inclusion of antibiotic resistance genes in the introduced genetic material in microorganisms qualifying for the TSCA 5(h)(4) exemption.  This second proposed rule was scheduled to be issued in June 2017.
  2. RIN 2070-AJ99:  Long-Chain Perfluoroalkyl Carboxylate and Perfluoroalkyl Sulfonate Chemical Substances; Significant New Use Rule.  The agenda states that EPA is re-proposing a significant new use rule (SNUR) under TSCA Section 5(a)(2) for long-chain perfluoroalkyl carboxylate (LCPFAC) chemical substances, and for perfluorooctanoic acid (PFOA) or its salts following changes under amended TSCA.  This second proposed rule is scheduled to be issued in October 2017 and is scheduled to be issued in final in October 2018.
  3. RIN 2070-AK07:  N-Methylpyrrolidone (NMP) and Methylene Chloride; Rulemaking Under TSCA Section 6(a).  The agenda states that EPA is developing a supplemental proposed rulemaking to address the risks from methylene chloride, specifically in commercial furniture refinishing as an industry.  This rulemaking is separate and apart from the proposed rule to ban certain uses of NMP and methylene chloride that was issued in January 2017.  The issuance of this supplemental proposed rule is TBD.
  4. RIN 2070-AK11:  Trichloroethylene (TCE); Rulemaking Under TSCA Section 6(a); Vapor Degreasing.  More information on this rulemaking is available in our blog item EPA Proposes Regulation of TCE Use in Vapor Degreasing under TSCA Section 6(a).  The comment period for this proposed rule ended in May 2017.  The issuance of the final rule is TBD. 
  5. RIN 2070-AK22:  Mercury; Reporting Requirements for the TSCA Mercury Inventory.  The agenda states that under amended TSCA, EPA is developing a proposed rule to implement TSCA Section 8(b)(10)(D) which requires EPA to issue a final rule no later than two years after the enactment of the TSCA amendments to establish reporting deadline(s) and information requirements for the purpose of assisting EPA's statutorily-mandated periodic update and publication of the inventory of mercury supply, use, and trade in the U.S.  This proposed rule is scheduled to be issued in October 2017 and is scheduled to be issued in final in June 2018.
  6. RIN 2070-AK27:  Service Fees for the Administration of the Toxic Substances Control Act.  The agenda states that under amended TSCA, EPA is developing a proposed rule to implement TSCA Section 26(b)(1) which authorizes EPA to issue a rule to establish fees to defray the cost of administering TSCA Sections 4, 5, and 6, and collecting, processing, reviewing, and providing access to and protecting from disclosure as appropriate under Section 14 information on chemical substances (including contractor costs incurred by the Agency).  More information on this rulemaking is available in our memoranda TSCA Reform:  An Analysis of Key Provisions and Fundamental Shifts in the Amended TSCA.  The proposed rule is scheduled to be issued in August 2017 and the final rule is scheduled to be issued in June 2018
  7. RIN 2070-AK31:  TSCA Chemical Data Reporting; Requirements for Inorganic Byproducts.  The agenda states that under amended TSCA, EPA is developing a proposed rule to implement TSCA Section 8(a)(6)(A) which requires EPA to enter into a negotiated rulemaking and develop and publish a proposed rule within three years of enactment that addressed chemical data reporting requirements for manufacturers of any inorganic byproducts, when such byproducts, whether by the byproduct manufacturer or by any other person, are subsequently recycled, reused, or reprocessed.  The proposed rule is scheduled to be issued in May 2018.
  8. RIN 2070-AK30:  Labeling Relief; Formaldehyde Emission Standards for Composite Wood Products.  On July 11, 2017, EPA issued a direct final rule and a parallel proposed rule that the agenda states “clarify requirements for labeling composite wood products and finished goods made entirely of composite wood products,” in response to stakeholders’ concerns that certain new requirements resulting from the implementation of the Formaldehyde Standards for Composite Wood Products Act (via final rule issued on December 12, 2016) may give rise to unintended supply chain disruptions as the compliance deadline established approaches.  The direct final rule is scheduled to become effective on August 25, 2017, unless adverse comments are received by July 26, 2017.  Comments on the proposed rule were due on July 26, 2017.
  9. RIN 2070-AK35:  Compliance Date Extension; Formaldehyde Emission Standards for Composite Wood Products.  On May 24, 2017, EPA issued a direct final rule and a parallel proposed rule that intended to extend the Formaldehyde Emission Standards for Composite Wood Products final rule (issued Dec. 12, 2016) compliance dates, and extend the California Air Resources Board Third Party Certifiers transitional period.  On July 6, 2017, EPA withdrew the direct final rule and the proposed rule after it received adverse comment.  The Federal Register notice withdrawing the final rule and the proposed rule states that EPA will proceed with a final rule based on the proposed rule after considering all public comments, but no further updates were provided.
  10. RIN 2070-AK36:  Voluntary Consensus Standards Update; Formaldehyde Emission Standards for Composite Wood Products.  The agenda states that EPA intends to issue a direct final rule and a parallel proposed rule to amend the December 2016 final rule on Formaldehyde Emission Standards for Composite Wood Products to correctly reference the current voluntary consensus standards as some of them have been updated, superseded or withdrawn.  The voluntary consensus standards that were incorporated in the final rule address a variety of topics, including material performance requirements and construction, test methods, and conformity assessments.  This proposed rule and direct final rule were scheduled to be issued in June 2017. 

The one item in the prerule stage is:

  • RIN 2070-AK29:  TSCA Reporting and Recordkeeping Requirements; Standards for Small Manufacturers and Processors.  The agenda states that under amended TSCA, EPA is developing an action to implement TSCA Section 8(a)(3)(C) which requires that EPA, after consultation with the Administrator of the Small Business Administration, to review the adequacy of the standards for determining the manufacturers and processors which qualify as small manufacturers and processors for purposes of TSCA Sections 8(a)(1) and 8(a)(3), and, after providing public notice and an opportunity for comment, make a determination as to whether revision of the standards is warranted.  More information on this action and the initial notice issued in December 2016 is available in our blog item EPA Requests Public Comment on Revision of Current Size Standard Definitions Under TSCA.  A second notice was scheduled to be issued in June 2017.  

 
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