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

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  EPA also released draft guidance to assist in developing and submitting draft risk evaluations.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will provide feedback on the final rules in upcoming memoranda on each final rule, as well as a memorandum on the draft guidance on developing risk evaluations.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.


 

By Lynn L. Bergeson and Margaret R. Graham

On June 13, 2017, the White House Office of Management and Budget (OMB) received a notice from the U.S. Environmental Protection Agency (EPA) submitting its draft Guidance to Assist Interested Persons in Developing and Submitting Draft Risk Evaluations Under the Toxic Substances Control Act (TSCA) (RIN 2070-ZA18) for review and approval.  Under Section 26(l)(5), EPA is required, “[n]ot later than 1 year after the date of enactment … [to] develop guidance to assist interested persons in developing and submitting draft risk evaluations which shall be considered by the Administrator.”  While the “framework rules” have been the subject of considerable focus since last June, this guidance is as important, subject to the one year deadline, and likely to provide significant insights into EPA’s thinking on risk evaluations.  EPA must publish the final rule in the Federal Register by June 22, 2017.

More information on the final rule on Procedures for Evaluating Existing Chemical Risks under TSCA is available in our memorandum EPA Releases Proposed Chemical Risk Evaluation Process under New TSCA.


 

By Lynn L. Bergeson and Margaret R. Graham

The U.S. Environmental Protection Agency (EPA) has released a pre-publication version of its direct final rule signed on April 5, 2017, which states that EPA will be promulgating significant new use rules (SNUR) under the Toxic Substances Control Act (TSCA) for 37 chemical substances which were the subject of premanufacture notices (PMN).  This action will require persons who intend to manufacture or process any of these 37 chemical substances for an activity that is designated as a significant new use (SNU) by this rule to notify EPA at least 90 days before commencing that activity.  This final rule will become effective 60 days after publication in the Federal Register.  We note that all of these substances were reviewed under old TSCA, prior to June 22, 2016.  The 37 chemical substances are:

  • PMN Number P-05-436:  Ethylene glycol ester of an aromatic substituted propenoic acid (generic);
  • PMN Number P-10-504:  Phosphoric acid, metal salt (generic);
  • PMN Number P-13-289:  Alkanoic acid, tetramethylheteromonocycle ester (generic); PMN Number P-13-908:  Polyether polyester urethane phosphate (generic);
  • PMN Number P-14-129; CAS Number: 35123:  Propanamide, 2-hydroxy-N,N-dimethyl-. -06-9;
  • PMN Number P-14-260; CAS Number: 1514-82-5:  1-Propene, 2-bromo-3,3,3-trifluoro-
  • PMN Number P-14-759:  Pyrolysis oil product (generic);
  • PMN Number P-15-279; CAS Number: 1613320-81-2:  1-Octanamine, 7 (or 8)-(aminomethyl);
  • PMN Number P-15-409: Substituted alkanolamine ether (generic);
  • PMN Number P-15-583:  Butanedioic acid, alkyl amine, dimethylbutyl ester (generic);
  • PMN Number P-15-672:  Carbon nanotube (generic);
  • PMN Number P-15-678: Metal salt of mineral acid, reaction products with alumina, aluminum hydroxide, aluminum hydroxide oxide (Al(OH)O), silica, titanium oxide (TiO2) and 3-(triethoxysilyl)-1-propanamine (generic);
  • PMN Numbers P-15-766 and P-15-767: Halogenated bisphenol A, polymer with epichlorohydrin, alkenoate (generic) (P-15-766); and Halogenated bisphenol A, polymer with bisphenol A diglycidyl ether and epoxidized phenol-formaldehyde resin, alkenoate (generic) (P-15-767); 
  • PMN Number P-16-14:  Silicon, tris[dialkyl phenyl]-dialkyl-dioxoalkane-naphthalene disulfonate (generic);
  • PMN Number P-16-40: Tar acids fraction (generic);
  • PMN Numbers P-16-59 and P-16-60: Dialkyl fattyalkylamino propanamide alkylamine (generic) (P-16-59) and Fattyalkylaminopropanoate ester (generic) (P-16-60);
  • PMN Number P-16-70; CAS Number: 200443-98-7: Boron sodium oxide (B5NaO8), labeled with boron-10;
  • PMN Number P-16-94: Perfluoropolyether modified organosilane (generic);
  • PMN Number P-16-95: Modified phenol-formaldehyde resin (generic);
  • PMN Number P-16-101: Disubstituted benzene alkanal (generic);
  • PMN Number P-16-102:  Phthalic anhydride, polymer with alkylene glycol and alkanepolyol, acrylate (generic);
  • PMN Number P-16-104; CAS Number: 1546765-39-2:  2-Pyridinecarboxylic acid, 4,5-dichloro-6-(4-chloro-2-fluoro-3-methoxyphenyl)-;
  • PMN Numbers P-16-136, P-16-139, and P-16-140:  Dialkylamino alkylamide inner salt (generic);
  • PMN Number P-16-170:  Nanocarbon (generic);
  • PMN Number P-16-177; CAS Number: 1440529-21-4:  Barium molybdenum niobium tantalum tellurium vanadium zinc oxide;
  • PMN Number P-16-179:  Alkanoic acids, esters with alkanetriol (generic);
  • PMN Number P-16-182:  (1) Manganese, tris[.mu.-(2-ethylhexanoato-.kappa.O:.kappa.O’)]bis(octahydro-1,4,7-trimethyl-1H-1,4,7-triazonine-.kappa.N1,.kappa.N4,.kappa.N7)di- (CAS Number 2020407-62-7; Chemical A); (2) Manganese, [.mu.-(acetato-.kappa.O:.kappa.O’)]bis[.mu.-(2-ethylhexanoato-.kappa.O:.kappa.O’)]bis(octahydro-1,4,7-trimethyl-1H-1,4,7-triazonine.kappa.N1,.kappa.N4,.kappa.N7)di- (CAS Number 2020407-63-8; Chemical B); (3) Manganese, bis[.mu.-(acetato-.kappa.O:.kappa.O’)][.mu.-(2-ethylhexanoato-.kappa.O:.kappa.O’)]bis(octahydro-1,4,7-trimethyl-1H-1,4,7-triazonine-.kappa.N1,.kappa.N4,.kappa.N7)di- (CAS Number 2020407-64-9; Chemical C); and (4) Manganese, tris[.mu.-(acetato-.kappa.O:.kappa.O’)]bis(octahydro-1,4,7-trimethyl-1H-1,4,7-triazonine-.kappa.N1,.kappa.N4,.kappa.N7)di- (CAS Number 2020407-65-0; Chemical D);
  • PMN Number P-16-190:  Aryl polyolefin (generic);
  • PMN Number P-16-260:  Melamine nitrate (generic); and
  • PMN Number P-16-272; CAS Number: 308068-11-3:  Lecithins, soya, hydrogenated.
Tags: PMN, SNUR, EPA

 

By Lynn L. Bergeson and Margaret R. Graham

On June 1, 2017, the U.S. Environmental Protection Agency (EPA) submitted its final rulemaking on the Procedures for Evaluating Existing Chemical Risks under the Toxic Substances Control Act (TSCA) to the Office of Management and Budget (OMB) for review and approval.  

EPA’s proposed rule describes a process for conducting risk evaluations to determine whether a chemical substance presents an unreasonable risk of injury to health or the environment, including an unreasonable risk to a potentially exposed or susceptible subpopulation, under the conditions of use; and identifies the steps of a risk evaluation process including scope, hazard assessment, exposure assessment, risk characterization, and finally a risk determination.  This process would be used for the first ten chemical substances to be evaluated from the 2014 update of the TSCA Work Plan for Chemical Assessments, chemical substances designated as High-Priority Substances during the prioritization process, and those chemical substances for which EPA has initiated a risk evaluation in response to manufacturer requests. Comments were due March 20, 2017; 87 comments were filed.  Pursuant to new TSCA, EPA must publish the final rule in the Federal Register by June 22, 2017

More information on the rule as proposed is available in our memorandum EPA Releases Proposed Chemical Risk Evaluation Process under New TSCA.


 

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 23, 2017, the U.S. Environmental Protection Agency (EPA) submitted its final rulemaking on the Procedures for Prioritization of Chemicals for Risk Evaluation Under the Toxic Substances Control Act (TSCA) to the Office of Management and Budget (OMB) for review and approval.  In the proposed rule, EPA describes the processes for identifying potential candidates for prioritization, selecting a candidate, screening that candidate against certain criteria, formally initiating the prioritization process, providing opportunities for public comment, and proposing and preparing final priority designations.  EPA also incorporates all of the elements required by new TSCA, but also supplements those requirements with additional criteria it expects to consider, some clarifications intended to provide greater transparency, and additional procedural steps to ensure effective implementation.  Comments were due March 20, 2017; 70 comments were filed.  Pursuant to new TSCA, EPA must publish the final rule in the Federal Register by June 22, 2017

More information on the rule as proposed is available in our memorandum EPA Proposes Procedures to Prioritize Chemicals for Risk Evaluation under TSCA.


 

Bergeson & Campbell, P.C. (B&C®) is pleased to announce the publication of New TSCA: A Guide to the Lautenberg Chemical Safety Act and Its Implementation, released today by the American Bar Association (ABA).  This new book is a comprehensive guide to the substantial revisions to the Toxic Substances Control Act (TSCA) occasioned by enactment of the Frank R. Lautenberg Chemical Safety for the 21st Century Act on June 22, 2016, to produce “new TSCA,” amending and replacing “old TSCA” as of that date.  B&C Managing Partner Lynn L. Bergeson and Senior Regulatory and Policy Advisor Charles M. Auer are editors and co-authors, with contributions from B&C’s outstanding TSCA practice group, including Timothy D. Backstrom, Lisa R. Burchi, Lisa M. Campbell, Sheryl L. Dolan, Richard E. Engler, Ph.D., Margaret R. Graham, Oscar Hernandez, Ph.D., Carla N. Hutton, and Kathleen M. Roberts.
 
Readers of New TSCA: A Guide to the Lautenberg Chemical Safety Act and Its Implementation will gain an appreciation of the fundamental shifts in the requirements and approach to chemical management under new TSCA, and will benefit from thorough analysis of a number of the provisions, including those relating to definitions, testing, review and regulation of new and existing chemicals, information reporting, confidential business information (CBI), preemption, fees, and others.  A 15-page Executive Summary of the book is available on the ABA website.

Reflecting on the book, Ms. Bergeson stated:  “New TSCA: A Guide to the Lautenberg Chemical Safety Act and Its Implementation reflects the expert counsel and advice of seasoned scientific and regulatory professionals and, of course, the essential views of former U.S. Environmental Protection Agency regulators and scientists, each of whom knows intimately the law, policy, and science of TSCA. Collectively, there is no stronger, more experienced TSCA team in the country to assist the regulated community tackle the challenges posed and seize the opportunities presented by the new law."
 

New TSCA: A Guide to the Lautenberg Chemical Safety Act and Its Implementation is available for purchase via the ABA online bookstore.


 

By Lynn L. Bergeson and Margaret R. Graham

The U.S. Small Business Administration’s (SBA) Office of Advocacy (Advocacy) has announced that it will be hosting regional small business roundtables “to hear firsthand from small businesses facing regulatory burdens [on] … which federal agency regulations should be considered for reform or elimination,” and “which regulations are problematic for your business,” as a result of the recent Executive Orders 13771 and 13777 on regulatory reform.

The first two roundtables in this series will be held on June 7, 2017, and June 8, 2017, in Baton Rouge and New Orleans, Louisiana, respectively.  Several more are expected to be scheduled soon for Boise, Idaho, Phoenix, Arizona, and St. Louis, Missouri, among others.

The Advocacy website states that the purpose of regional regulatory roundtables is to:

  • Identify regional small business regulatory issues in order to assist agencies with regulatory reform and reduction in compliance with Executive Orders 13771 & 13777;
  • Compile crucial information for Advocacy’s new report on existing small business regulatory burdens across the nation, identifying specific recommendations for regulatory changes based upon first-hand accounts from small businesses across the country; and
  • Inform and educate the small business public as to how Advocacy and SBA can assist them with their small business.

Registration for the first two roundtables is available online:  Baton Rouge registration; New Orleans registration.  Advocacy is also accepting comments regarding regulatory reform via an online form.  More information on the Executive Orders and their implementation is available on our blog.


 

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

The U.S. Environmental Protection Agency (EPA) published a Federal Register notice on May 16, 2017, announcing the availability of and requesting public comment on a draft guidance document entitled “Guidance on EPA’s Section 8(a) Information Gathering Rule on Nanomaterials in Commerce.” 82 Fed. Reg. 22452.  The promised guidance provides answers to questions EPA has received from manufacturers (includes importers) and processors of certain chemical substances when they are manufactured or processed at the nanoscale as described in the January 12, 2017, final Toxic Substances Control Act (TSCA) Section 8(a) rule.  The final rule requires one-time reporting for existing discrete forms of certain nanoscale materials, and a standing one-time reporting requirement for new discrete forms of certain nanoscale materials.  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.”  EPA states that it will accept comments regarding the draft guidance, but not regarding the rule itself, “which has already been finalized.”  Comments are due June 15, 2017.

The 14-page draft guidance, in the form of questions and answers, addresses questions within the following categories:  what chemicals are reportable; who is required to report; information that is to be reported; when is reporting required; general questions; and confidentiality.  While the publication of draft guidance within four months of promulgation of the final rule is an achievement, the draft guidance does not significantly expand upon that which is already known, or make the rule clearer or easier with which to comply.  Companies subject to the reporting requirements of the final rule can expect to continue to struggle in sorting out what discrete forms are required to be reported.  More information regarding the draft guidance is available in our May 16, 2017, memorandum, “EPA Seeks Comment on Draft Guidance for Nanoscale Materials Reporting Rule.”


 
 1 2 3 >  Last ›