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 Kathleen M. Roberts

On October 12, 2017, the U.S. Environmental Protection Agency (EPA) issued a notice in the Federal Register announcing the cancellation of the fourth meeting of the Negotiated Rulemaking Committee for Chemical Data Reporting (CDR) requirements for inorganic byproducts (Reg Neg Committee) scheduled for October 25-26, 2017.  82 Fed. Reg. 47423. 

During their September 13-14, 2017, meeting, the members of the Reg Neg Committee concluded that further dialogue within the Committee context would be unproductive, and that the fourth meeting was not necessary.  EPA is, however, still providing the public an opportunity to weigh in on the legislative directive to reduce the CDR reporting burden for inorganic substances that are recycled, while maintaining EPA’s access to exposure information needed for risk assessment purposes.  The notice states that the Reg Neg Committee docket will remain open until December 11, 2017, to allow for public comment.

The Reg Neg Committee was established to respond to the legislative mandate under Section 8(a)(6)(A) of the Frank R. Lautenberg Chemical Safety for the 21st Century Act, which states:

The [EPA] Administrator shall enter into a negotiated rulemaking … to develop and publish … a proposed rule providing for limiting the reporting requirements, under this subsection, 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.

During the first set of Reg Neg Committee meetings, EPA stressed its desire to implement the outcome of the Reg Neg Committee work during the next CDR reporting cycle in 2020.  To achieve this timeline, the Committee would need to reach a consensus on an approach or approaches by the October 2017 meetings.   While several different stakeholder organizations offered proposals for consideration, it became clear to Committee members during the September 14-15, 2017, meeting that those proposals would not have consensus support because they either required considerable further refinement and discussion beyond the October 2017 timeframe; did not provide EPA with appropriate exposure information needed for risk assessment; or did not adequately achieve the mandated goal of limiting reporting requirements. 

It is unclear if EPA will be able to complete the myriad of tasks needed to take a proposal received during the public comment period to final implementation before the 2020 CDR reporting cycle, as this would require EPA to complete a thorough analysis of additional proposals, consider potential impacts to the EPA offices, develop a proposed rulemaking, obtain public review and comment on the proposal, issue a final rulemaking, and provide clear and detailed guidance on the new approaches for reporting on recycled inorganic products prior to the 2020 CDR reporting cycle. 

More information on the negotiated rulemaking process as related to inorganic byproducts is available on our blog under key phrases negotiated rulemaking and inorganic byproducts.


 

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.


 

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 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.  

 

By Lynn L. Bergeson and Margaret R. Graham

On July 20, 2017, the U.S. Environmental Protection Agency (EPA) published two of the three Toxic Substances Control Act (TSCA) framework final rules in the Federal Register:

These rules will become effective on September 18, 2017. The TSCA Inventory Notification (Active-Inactive) Reporting Requirements final rule has not yet been published.  EPA also published the notice of availability of its guidance to assist in developing and submitting draft risk evaluations:

More information on these final rules and the guidance are available in our memorandum EPA Issues Final TSCA Framework Rules.  


 

By Lynn L. Bergeson and Margaret R. Graham

On July 7, 2017, the U.S. Environmental Protection Agency (EPA) published a notice in the Federal Register announcing the availability of the scope documents for the risk evaluations of the first ten chemicals that it will be conducting under the amended Toxic Substances Control Act (TSCA).  82 Fed. Reg. 31592.  The notice states that each scope document includes “the hazards, exposures, conditions of use, and the potentially exposed or susceptible subpopulations the EPA expects to consider in conducting the risk evaluation.”  The direct links to the scope documents are available in our blog item EPA Issues Much Anticipated Three Final TSCA Framework Rules, Guidance on Draft Risk Evaluations, and Scoping Documents on Risk Evaluations of First Ten Chemicals under Revised TSCA.

The notice also reiterates that EPA is re-opening existing dockets for the first ten chemicals to “allow for the public to provide additional data or information that could be useful to the Agency in conducting problem formulation, the next step in the process of conducting the risk evaluations for these chemicals.”  More information on the reopening of the dockets for public comments, including links to the individual dockets, is available in our blog item EPA Opens Comment Period on Risk Evaluations for First Ten Chemicals under Revised TSCA.  As stated in the memo reopening the dockets, but curiously not stated in the published notice (no dates were included), comments are due September 19, 2017.


 

By Lynn L. Bergeson, Carla N. Hutton, Charles M. Auer, Oscar Hernandez, Ph.D., and Richard E. Engler, Ph.D.

On June 26, 2017, Bergeson & Campbell, P.C. (B&C®) issued a summary and analysis of the three final Toxic Substances Control Act (TSCA) framework rules released by the U.S. Environmental Protection Agency (EPA) on June 22, 2017, EPA Issues Final TSCA Framework Rules.  The final rules include the prioritization process rule, which establishes EPA’s process and criteria for identifying High-Priority chemicals for risk evaluation and Low-Priority chemicals for which risk evaluation is not warranted at this time; the risk evaluation process rule, which establishes EPA’s process for evaluating High-Priority chemicals to determine whether or not they present an unreasonable risk to health or the environment; and the TSCA Inventory active-inactive rule, which requires industry to report chemicals manufactured, imported, or processed in the U.S. over the past ten years.  EPA also published pre-publication notices concerning the scopes of the risk evaluations to be conducted for the first ten chemical substances under new TSCA and a guidance document to assist interested persons in developing and submitting draft risk evaluations.

B&C states that on the whole, the final rules improve upon the proposed rules, adding clarity and specificity where needed, and eliminating provisions and or preamble text that, in our view, enhance the clarity of the rules.  Not everyone will be happy, however, as the rules reconsider, revise, and in some instances retreat from positions taken in the proposed rules issued under the Obama Administration. Our analysis identifies these changes.


 

By Lynn L. Bergeson

As required by the amended Toxic Substances Control Act (TSCA), on June 22, 2017, one year after passage of the Frank R. Lautenberg Chemical Safety for the 21st Century Act, the U.S. Environmental Protection Agency (EPA) has issued the three framework rules in final.  EPA also released draft guidance to assist in developing and submitting draft risk evaluations.  The final rules are:

  1. Procedures for Chemical Risk Evaluation;
  2. Procedures for Prioritization of Chemicals for Risk Evaluation; and
  3. TSCA Inventory Notification (Active-Inactive) Requirements

EPA also released scoping documents of the risk evaluations and supplemental resources on the first ten chemicals under amended TSCA, as it stipulated in its annual report on risk evaluations.  Links to the scoping documents for these ten chemicals, as well as strategies for conducting literature searches, are below:

  1. 1, 4-Dioxane;
  2. Methylene Chloride;
  3. 1-Bromopropane;
  4. N-Methylpyrolidone (NMP);
  5. Asbestos;
  6. Pigment Violet 29;
  7. Carbon Tetrachloride;
  8. Trichloroethylene;
  9. Cyclic Aliphatic Bromide Cluster (HBCD); and
  10. Tetrachloroethylene (perchloroethylene).

Administrator Scott Pruitt signed them and they were released to the general public shortly thereafter.  They are expected to be effective 60 days after publication in the Federal Register.  Bergeson & Campbell, P.C. (B&C®) will provide feedback on the final rules in upcoming memoranda on each final rule, as well as a memorandum on the draft guidance on developing risk evaluations.  Please look for these memoranda on our website under “Regulatory Developments.”


 

By Lynn L. Bergeson and Margaret R. Graham

On June 19, 2017, the U.S. Environmental Protection Agency posted a memo authorizing the opening of comment periods for the public to comment on the risk evaluation process for the first ten chemicals it is evaluating under the revised Toxic Substances Control Act (TSCA) to determine whether they “present an unreasonable risk of injury to health or the environment.”  Specifically, EPA states it is interested in “information from the public that could be useful to the Agency in conducting problem formulation,” which is the “next step in the process of conducting the required risk evaluations for these chemicals.”  Comments are due September 19, 2017.

EPA’s 2017 Annual Report on Risk Evaluations issued in February stated that it expected to issue a scoping document on each of the individual chemicals by June 19, 2017, which must include “the hazard(s), exposure(s), condition(s) of use, and the potentially exposed or susceptible subpopulation(s) the Administrator expects to consider in the evaluation.”  EPA has not yet issued the scoping documents, but is expected to do so soon. After the scoping documents have been published, EPA stated that it would “continue with the risk evaluation process as described in the statute and the associated Risk Evaluation Rule [to be issued in final on June 22, 2017], with the expectation to complete the risk evaluation in the 3-3.5 year timeframe required by law.”

The list of ten chemicals and their corresponding docket ID numbers are:

  1. 1, 4 Dioxane, EPA-HQ-OPPT-2016-0723;
  2. Methylene Chloride, EPA-HQ-OPPT-2016-0742;
  3. 1-Bromopropane, EPA-HQ-OPPT-2016-0741;
  4. N-Methylpyrolidone (NMP), EPA-HQ-OPPT-2016-0743;
  5. Asbestos, EPA-HQ-OPPT-2016-0736;
  6. Pigment Violet 29, EPA-HQ-OPPT-2016-0725;
  7. Carbon Tetrachloride, EPA-HQ-OPPT-2016-0733;
  8. Trichloroethylene, EPA-HQ-OPPT-2016-0737;
  9. Cyclic Aliphatic Bromide Cluster (HBCD), EPA-HQ-OPPT-2016-0735; and
  10. Tetrachloroethylene, EPA-HQ-OPPT-2016-0732.

Revised TSCA requires that the three framework rules, which include the procedures for evaluating existing chemical risks rule (Risk Evaluation Rule), the procedures to prioritize chemicals for risk evaluation rule, and the requirements for TSCA Inventory notification (active-inactive) rule, be issued in final by June 22, 2017.   

More information on these framework rules will be available on our blog after they are issued in final.


 
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