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, Carla N. Hutton, and Jessie Nguyen

On May 9, 2018, the Office of Information and Regulatory Affairs (OIRA) posted the Spring 2018 Unified Agenda and Regulatory Plan.  OIRA states that the semi-annual Unified Agenda and Regulatory Plan “provide uniform reporting of data on regulatory and deregulatory actions under development throughout the Federal government, covering over 60 departments, agencies, and commissions.”  Below are highlights of rulemakings from the U.S. Environmental Protection Agency’s (EPA) Office of Chemical Safety and Pollution Prevention (OCSPP) that are related to the Toxic Substances Control Act (TSCA):

  • Microorganisms:  General Exemptions From Reporting Requirements; Revisions of Recipient Organisms Eligible for Tier I and Tier II Exemptions (RIN 2070-AJ65):  EPA promulgated a final rule under TSCA Section 5 to establish notification procedures for review of certain new microorganisms before they are introduced into commerce.  EPA received petitions to add Trichoderma reesei and Bacillus amyloliquefaciens to the list of microorganisms that may be used as recipient microorganisms to qualify for the exemption from full notification and reporting.  Based on EPA’s evaluation of these petitions, EPA states that it made a preliminary determination that certain strains of both microorganisms 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, and issued a proposed rule.  EPA is developing a revised proposal that will address concerns raised by commenters, and is considering expanding the earlier proposal to prohibit the inclusion of antibiotic resistance genes in the introduced genetic material in microorganisms qualifying for the TSCA Section 5(h)(4) exemption.  EPA intended to issue a notice of proposed rulemaking (NPRM) in May 2018;
  • Long-Chain Perfluoroalkyl Carboxylate (LCPFAC) and Perfluoroalkyl Sulfonate (PFAS) Chemical Substances; Significant New Use Rule (SNUR) (RIN 2070-AJ99):  EPA is developing a SNUR under TSCA Section 5(a)(2) for LCPFAC chemical substances, and for perfluorooctanoic acid (PFOA) or its salts.  On January 21, 2015, EPA proposed to amend a SNUR for LCPFAC chemical substances by designating as a significant new use manufacturing (including importing) or processing of an identified subset of LCPFAC chemical substances for any use that will not be ongoing after December 31, 2015, and all other LCPFAC chemical substances for which there are currently no ongoing uses.  EPA also proposed to make inapplicable the exemption for persons who import LCPFAC chemical substances as part of articles.  In addition, EPA proposed to amend a SNUR for PFAS chemical substances that would make inapplicable the exemption for persons who import PFAS chemical substances as part of carpets.  EPA intended to issue a supplemental NPRM in May 2018 following changes to TSCA brought about by the Frank R. Lautenberg Chemical Safety for the 21st Century Act.  EPA plans to issue a final rule in July 2019;
  • Procedural Rule:  Review of Confidential Business Information (CBI) Claims for the Identity of Chemicals on the TSCA Inventory -- Amended TSCA Section 8(b)(4)(C) (RIN 2070-AK21):  EPA is developing a proposed rule to implement TSCA Section 8(b)(4)(C), which requires EPA to establish a plan to review all claims to protect the specific chemical identities of chemical substances on the confidential portion of the active  TSCA Inventory.  EPA intends to publish an NPRM in January 2019 and a final rule in December 2019;
  • TSCA Chemical Data Reporting (CDR) Revisions (RIN 2070-AK33):  EPA will revise the reporting requirements to align better with new TSCA requirements.  EPA intends to issue an NPRM in September 2018 and a final rule in September 2019;
  • Significant New Uses of Chemical Substances; Updates to the Hazard Communication Program and Regulatory Framework; Minor Amendments to Reporting Requirements for Premanufacture Notices (RIN 2070-AJ94):  On July 28, 2016, EPA issued a rule proposing changes to the applicable Significant New Uses of Chemical Substances regulations to align EPA’s regulations, where possible, with the final revisions to the Occupational Safety and Health Administration’s (OSHA) Hazard Communications Standards.  EPA intends to issue a final rule in September 2018;
  • Certain Nonylphenols (NP) and Nonylphenol Ethoxylates (NPE); SNUR (RIN 2070-AJ96):  On October 1, 2014, EPA issued a proposed SNUR under TSCA Section 5(a)(2) for certain NPs and NPEs.  EPA intends to issue a final SNUR in December 2018;
  • Mercury; Reporting Requirements for the TSCA Mercury Inventory (RIN 2070-AK22):  On October 26, 2017, EPA issued a rule proposing reporting requirements under TSCA Section 8(b)(10)(D) for applicable persons to provide information to assist in the preparation of an “inventory of mercury supply, use, and trade in the United States,” where mercury is defined as “elemental mercury” and “a mercury compound.”  EPA intends to issue a final rule in June 2018; and
  • Service Fees for the Administration of TSCA (RIN 2070-AK27):  On February 26, 2018, EPA issued a rule proposing to implement TSCA Section 26(b)(1), which authorizes EPA to issue a rule to establish fees to defray the cost of administering 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.  EPA intends to issue a final rule in August 2018.

 

By Lynn L. Bergeson and Margaret R. Graham

On April 19, 2018, the Office of Management and Budget’s (OMB) Office of Information and Regulatory Affairs (OIRA) received the U.S. Environmental Protection Agency’s (EPA) proposed rule entitled “Strengthening Transparency and Validity in Regulatory Science.”  This new proposed rule, item 2080-AA14, has not been published in the regulatory agenda; the only information available concerning the content of this rule is its title.

 On April 11, 2018, OIRA received an advanced notice of proposed rulemaking from EPA entitled “Increasing Consistency and Transparency in Considering Costs and Benefits in the Rulemaking Process.”  The OIRA 2017 Fall Regulatory Agenda for this rulemaking, item RIN 2010-AA12, states that EPA is considering “developing implementing regulations that would increase consistency across EPA divisions and offices, increase reliability to affected stakeholders, and increase transparency during the development of regulatory actions,” and that by developing implementing regulations through a notice-and-comment rulemaking process “it will provide the public with a better understanding on how EPA is evaluating costs when developing a regulatory action and allow the public to provide better feedback to EPA on potential future proposed rules.”

 More information on regulatory agenda items is available on our blog under key phrase regulatory agenda.


 

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 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 Margaret R. Graham

On June 5, 2017, the U.S. Environmental Protection Agency (EPA) is scheduled to publish in the Federal Register a notice of public meetings and a notice regarding the establishment of the Negotiated Rulemaking Committee (NRC).  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.”  The prepublication version is available online.  

EPA’s notice lists the stakeholder groups from which EPA plans to invite representatives to participate as members of the Committee -- all of whom have been “identified as having a definable stake in the outcome of the proposed requirements”: 

  • Inorganic chemical manufacturers and processors, including metal mining and related activities;
  • Recyclers, including scrap recyclers;
  • Industry advocacy groups;
  • Environmental advocacy groups; and
  • Federal, State, and Tribal governments.

The first meeting will be held on June 8, 2017, from 9 a.m. to 5 p.m. (EDT) and on June 9, 2017, from 9 a.m. to 3:00 p.m. (EDT).  The second Committee meeting will be held on August 16, 2017, from 9 a.m. to 5 p.m. (EDT) and on August 17, 2017, from 9 a.m. to 3:00 p.m. (EDT).  Both meetings will be held at EPA’s Headquarters in Washington, D.C.

More information on the NRC is available on our blog under key phrase negotiated rulemaking.


 

By Lynn L. Bergeson and Margaret R. Graham

On May 2, 2017, the U.S. Environmental Protection Agency (EPA) announced it would convene a public meeting to clarify and discuss the process of negotiated rulemaking on changes to Chemical Data Reporting (CDR) requirements for inorganic byproducts.  The meeting will be held on May 9, 2017, from 9:00 a.m. to 5:00 p.m. (EDT) and on May 10, 2017, from 9:00 a.m. to 3:00 p.m. (EDT), in Washington, D.C. at the Capital Hilton, 1001 16th Street, N.W, in the General Session Room (South American AB). 

On December 15, 2017, EPA published a notice in the Federal Register of its intention to establish a Negotiated Rulemaking Committee (NRC) under the Federal Advisory Committee Act (FACA) and the Negotiated Rulemaking Act.  81 Fed. Reg. 90843.  The NRC will implement the amended Toxic Substances Control Act (TSCA) Section 8(a)(6) requirement that EPA “enter into a negotiated rulemaking … to develop and publish, not later than 3 years after the date of enactment … a proposed rule providing for limiting the reporting requirements under this subsection for manufacturers of any inorganic byproducts, if the byproducts, whether by the byproduct manufacturer or by any other person, are subsequently recycled, reused, or reprocessed.”  EPA states that it is holding this public meeting prior to the establishment of that NRC to “exchange information and clarify a number of aspects of inorganic byproduct identification and reporting.”

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 May 8, 2017.  Parties interested in making an oral presentation at the meeting should submit requests by e-mail to .(JavaScript must be enabled to view this email address) no later than May 8, 2017, to be placed on the list of public speakers.  As there are many questions about the scope of the negotiated rulemaking and the process that the initiative will follow, interested stakeholders are urged to participate.

Information about attending this meeting and its agenda will be posted to the NRC website.  More information on the establishment of the NRC is available in our blog item EPA To Establish Negotiated Rulemaking Committee Under Amended TSCA.


 

By Lynn L. Bergeson and Charles M. Auer

On December 21, 2016, the U.S. Environmental Protection Agency (EPA) published a final rule regarding procedures for rulemaking under Section 6 of the Toxic Substances Control Act (TSCA) in the Federal Register.  Under TSCA Section 6, EPA has the authority to address risks from chemical substances, and Section 6 includes procedures that EPA must follow.  As amended by the Frank R. Lautenberg Chemical Safety for the 21st Century Act, TSCA no longer mandates certain procedural requirements, and this rulemaking removes the regulations specifying those procedures. The final rule is effective on the date of publication, December 21, 2016.

The final rule appears to amend the Section 6 procedural requirements such that they align with the amended requirements under new TSCA.  While the procedural simplifications in new TSCA were a useful change that should better enable regulatory action on existing chemicals, EPA will need to exercise care in its future rulemaking to meet the procedural requirements that remain in Section 6, as well as satisfy the relevant provisions in Section 26.  More information regarding this final rule is available in our memorandum TSCA:  EPA Amends Procedures for TSCA Section 6 Rulemaking.


 

By Lynn L. Bergeson, Charles M. Auer, Kathleen M. Roberts, and Margaret R. Graham

On December 15, 2016, the U.S. Environmental Protection Agency (EPA) published a notice in the Federal Register of its intention to establish a Negotiated Rulemaking Committee (NRC) under the Federal Advisory Committee Act (FACA) and the Negotiated Rulemaking Act.  81 Fed. Reg. 90843.  The NRC will implement the amended Toxic Substances Control Act (TSCA) Section 8(a)(6) requirement that EPA “enter into a negotiated rulemaking … to develop and publish, not later than 3 years after the date of enactment … a proposed rule providing for limiting the reporting requirements under this subsection for manufacturers of any inorganic byproducts, if the byproducts, whether by the byproduct manufacturer or by any other person, are subsequently recycled, reused, or reprocessed.”

In a webinar presented by Bergeson & Campbell, P.C. (B&C®) earlier this fall, we noted the significance of this rulemaking for many entities subject to reporting requirements under TSCA’s Chemical Data Reporting (CDR) provisions under Section 8(a).  A “byproduct” is defined as a chemical substance produced without a separate commercial intent during the manufacture, processing, use, or disposal of another chemical substance or mixture.  EPA is of the view that byproducts without a separate commercial value are nonetheless produced for the purpose of obtaining commercial advantage since they are part of the manufacture of a chemical substance produced for commercial purpose.  Accordingly, byproducts are considered manufactured substances under TSCA and must be listed on the TSCA Inventory and, therefore, reportable under the CDR -- unless they are exempt.  Byproducts are exempt from Inventory listing and CDR reporting if their only commercial purpose is use by public or private organizations that burn it as a fuel, dispose of it as a waste, or extract component chemical substances from it for commercial purposes.

EPA has interpreted “extract component chemical substances from it” narrowly and has determined the exemption is voided if an extraction process involves a chemical reaction.  Stakeholders have long asserted that this interpretation discourages recycling programs that necessarily involve a chemical reaction, processes that are frequently used to extract commercially valuable metals or other materials from byproducts that would otherwise be destined for disposal.  The speed with which EPA has moved to implement this provision reflects EPA’s interest in ensuring this regulatory disconnect is addressed before the next CDR reporting cycle in 2020.

The notice states that the main purpose of the NRC is to conduct discussions in a good faith attempt to reach consensus on proposed regulatory language.  The notice provides a clear and comprehensive discussion of the negotiated rulemaking process and procedures, initially identifies specific parties that may be interested in participation, and requests comment on the extent to which the approaches described in the notice are adequate and appropriate.  The notice should be carefully reviewed by any entity having an interest in this issue.  Comments are due by January 17, 2017

We note in addition that the notice specifically discusses the Section 8(a) CDR rule as being relevant to the negotiation.  While we agree that the CDR is clearly of interest, we note that the negotiation as structured applies to any rule under Section 8(a), such as the Preliminary Assessment Information Rule (PAIR) (40 C.F.R. Part 712) and any chemical-specific Section 8(a) rules (40 C.F.R. Part 711).  At the same time, the negotiation as described in new TSCA is limited to Section 8(a) and does not address the issues of Inventory listing and potentially associated Section 5 notification requirements for inorganic byproducts.  We note also that as a FACA Committee, the NRC can consider and, by consensus, determine its interest in also picking up these closely related issues for discussion and attempt to develop a consensus approach.