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.
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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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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.  


 
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By Lynn L. Bergeson and Margaret R. Graham

On July 10, 2017, the U.S. Environmental Protection Agency (EPA) issued a prepublication version of a direct final rule, Significant New Use Rule on Certain Chemical Substances, noting the  issuance of  significant new use rules (SNUR) under the Toxic Substances Control Act (TSCA) for 29 chemical substances that were the subject of premanufacture notices (PMN) and subject to consent orders under TSCA Section 5(e).  These are the first rules with consent orders negotiated under new TSCA.  Persons who intend to manufacture or process any of the chemicals for an activity that is designated as a significant new use (SNU) by this rule must notify EPA at least 90 days before commencing that activity, and the notification will initiate EPA’s evaluation of the intended use within the applicable review period.  Further, “[p]ersons may not commence manufacture or processing for the significant new use until EPA has conducted a review of the notice, made an appropriate determination on the notice, and has taken such actions as are required with that determination.”  EPA will be accepting comments on these SNURs; comments will be due 30 days after publication in the Federal Register.  If comment deemed adverse is submitted after the rules are published in the Federal Register as to any of the 29 chemical substances, EPA will withdraw the rule and propose it for comment.  Comment will be due 30 days after publication.

EPA states it is issuing these SNURs for specific chemical substances which have undergone premanufacture review because it wants to achieve the following objectives with regard to the SNUs designated in this rule:

  1. EPA will receive notice of any person's intent to manufacture or process a TSCA Inventory listed chemical substance for the described significant new use before that activity begins;
  2. EPA will have an opportunity to review and evaluate data submitted in a SNUN before the notice submitter begins manufacturing or processing a listed chemical substance for the described significant new use;
  3. EPA will be able to either determine that the prospective manufacture or processing is not likely to present an unreasonable risk, or to take necessary regulatory action associated with any other determination, before the described significant new use of the chemical substance occurs; and
  4. EPA will ensure that all manufacturers and processors of the same chemical substance that is subject to a TSCA Section 5(e) consent order are subject to similar requirements.

The 29 chemicals are:

  • PMN Number: P-15-310; Chemical name: 1,2,4-Benzenetricarboxylic acid, mixed decyl and octyl triesters;
  • PMN Numbers:  P-15-487, P-15-488, P-15-489, P-15-490, and P-15-491; Chemical names: Multi-walled carbon nanotubes (generic);
  • PMN Number:  P-16-165; Chemical name: Propanoic acid, iron (2+) salt (2:1);
  • PMN Numbers:  P-16-255, P-16-256, P-16-257, P-16-258, and P-16-259; Chemical names:  1-Butanaminium, N,N,N-tributyl-, carbonic acid (1:1) (P-16-255), 1-Butanaminium, N,N,N-tributyl-, methyl carbonate (1:1) (P-16-256), 1-Butanaminium,N,N,N-tributyl-, ethyl carbonate (1:1) (P-16-257), 1-Butanaminium, N,N,N-tributyl-,propyl carbonate (1:1) (P-16-258), 1-Butanaminium, N,N,N-tributyl-, and 1-methylethyl carbonate (1:1) (P-16-259); CAS numbers: 17351-62-1(P-16-255), 56294-05-2(P-16-256), 478796-04-2(P-16-257), 1338579-13-7(P-16-258), and 1803407-49-9(P-16-259);
  • PMN Number:  P-16-284; Chemical name:  Anilino substituted bis-triazinyl derivative of 4,4'-diaminostilbene-2,2'- disulfonic acid, mixed amine sodium salt (generic);
  • PMN Numbers:  P-16-309 and P-16-310; Chemical names:  12-Hydroxystearic acid, reaction products with alkylene diamine and alkanoic acid (generic);
  • PMN Number:  P-16-315; Chemical name:  Alkyldiene, polymer, hydroxy terminated alkoxysilylalkylcarbamate (generic);
  • PMN Number:  P-16-323; Chemical name: Alkylaldehyde, reaction products with substituted carbomonocyclesubstituted heteromonocycle-alkylene glycol bis[[[[substituted(oxoneoalkyl)oxy]alkyl] amino]alkyl] ether polymer and alkyl substituted alkanediamine, acetate salts (generic);
  • PMN Numbers:  P-16-330 and P-16-331; Chemical names:  Hydroxy functional triglyceride polymer with glycerol mono-ester and 1,1'-methylenebis[4-isocyanatobenzene] (P-16-330) and Hydroxy functional triglyceride polymer with glycerol mono-ester and 1,1'-methylenebis[isocyanatobenzene] (P-16-331) (generic);
  • PMN Number:  P-16-360; Chemical name:  Poly(oxy-1,2-ethanediyl),.alpha.-(1-oxodocosyl)-.omega.-[(1- oxodocosyl)oxy]-;
  • PMN Number:  P-16-361;  Chemical name: Pulp, cellulose, reaction products with lignin;
  • PMN Numbers:  P-16-365 and P-16-367; Chemical names:  Alkyl carbonate, polymer with, substituted alkanes and substituted heteromonocycle, substituted alkyl acrylate-blocked (generic) (P-16-365) and substituted heteromonocycle, polymer with substituted alkane and ethoxylated alkane, substituted heteromonocycle substituted alkyl ester-blocked (generic) (P-16-367);
  • PMN Number:  P-16-369; Chemical name:  Substituted heteromonocycle, telomer with substituted carbomonocycles, substituted alkyl ester (generic);
  • PMN Number:  P-16-387;  Chemical name:  Aliphatic polycarboxylic acid, polymer with alicyclic polyhydric alcohol and polyoxyalkylene (generic);
  • PMN Number:  P-16-455; Chemical name:  Sodium tungsten oxide;
  • PMN Number:  P-16-503; Chemical name:  Fatty acids, tall-oil, polymers with alkanoic acid, substituted carbomonocycle, alkyl peroxide-initiated (generic); and
  • PMN Number:  P-16-591; Chemical name:  Alkyl bisphenol (generic).

 
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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.


 
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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.


 
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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.”


 
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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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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.


 
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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

 
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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.


 
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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.


 
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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.


 
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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.


 
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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.


 
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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.”


 
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