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By Lynn L. Bergeson and Carla N. Hutton

On August 20, 2019, the U.S. Environmental Protection Agency (EPA) published in the Federal Register final significant new use rules (SNUR) under the Toxic Substances Control Act (TSCA) for 145 chemical substances that are the subject of premanufacture notices (PMN).  84 Fed. Reg. 43266.  According to EPA, the chemical substances are subject to orders issued by EPA pursuant to TSCA Section 5(e).  The final SNURs require persons who intend to manufacture (defined by statute to include import) or process any of the 145 chemical substances for an activity that is designated as a significant new use by the rule to notify EPA at least 90 days before commencing that activity.  The required notification initiates EPA’s evaluation of the use, under the conditions of use for that chemical substance, within the applicable review period.  Persons 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 taken such actions as are required by that determination.  The final SNURs will take effect October 21, 2019.

EPA notes that the final SNURs may also affect certain entities through pre-existing import certification and export notification rules under TSCA.  Chemical importers are subject to TSCA Section 13 import certification requirements.  Chemical importers must certify that the shipment of the chemical substance complies with all applicable rules and orders under TSCA.  Importers of chemicals subject to the SNURs must certify their compliance with the SNUR requirements. Any persons who export or intend to export a chemical substance that is the subject of the SNURs on or after September 19, 2019, are subject to the export notification provisions of TSCA Section 12(b) and must comply with export notification requirements.

Tags: SNUR

 

By Lynn L. Bergeson and Carla N. Hutton
 
Section 5(g) of the Toxic Substances Control Act (TSCA) requires the U.S. Environmental Protection Agency (EPA) to publish a statement of its findings after its review of TSCA Section 5(a) notices when EPA makes a finding that a new chemical substance or significant new use is not likely to present an unreasonable risk of injury to health or the environment.  On August 12, 2019, EPA published a statement of its findings for June 2019.  84 Fed. Reg. 39828.  EPA notes that such statements apply to premanufacture notices (PMN), microbial commercial activity notices (MCAN), and significant new use notices (SNUN) submitted to EPA under TSCA Section 5.  In the Federal Register notice, EPA provides the following information (to the extent that such information is not claimed as confidential business information (CBI)) on the PMNs, MCANs, and SNUNs for which, during this period, EPA has made findings under TSCA Section 5(a)(3)(C) that the new chemical substances or significant new uses are not likely to present an unreasonable risk of injury to health or the environment:  EPA case number assigned to the TSCA Section 5(a) notice; chemical identity (generic name, if the specific name is claimed as CBI); and website link to EPA’s decision document describing the basis of the “not likely to present an unreasonable risk” finding made by EPA under TSCA Section 5(a)(3)(C). 


 

By Lynn L. Bergeson and Carla N. Hutton

The U.S. Environmental Protection Agency (EPA) announced on August 1, 2019, that it is making additional information about new chemical notices available on its website.  The new web page, “Statistics for the New Chemicals Review Program under TSCA,” allows users to view and search monthly updates for any active Premanufacture Notice (PMN), Significant New Use Notice (SNUN) and Microbial Commercial Activity Notice (MCAN) of interest by case number.  Users can also download a spreadsheet with a list of all active cases and each case’s status.  More information and commentary is available in our August 5, 2019, memorandum, "EPA Improves Transparency for New Chemicals Review Program under TSCA."


 

Bergeson & Campbell, P.C. (B&C®) is pleased to present the complimentary webinar “New TSCA at 3: Key Implementation Issues.” The webinar will drill down on key implementation challenges facing industry and the U.S. Environmental Protection Agency (EPA) three years into navigating the legal, regulatory, and science policy issues arising under the Frank R. Lautenberg Chemical Safety for the 21st Century Act (Lautenberg Act). Alexandra Dapolito Dunn, Assistant Administrator, EPA Office of Chemical Safety and Pollution Prevention (OCSPP); Lynn L. Bergeson, Managing Partner, B&C; and Richard E. Engler, Ph.D., Director of Chemistry, B&C, will present. Register online now.


 

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

On April 5, 2019, the U.S. Environmental Protection Agency (EPA) issued a final rule that will establish final significant new use rules (SNUR) under the Toxic Substances Control Act (TSCA) for 13 chemical substances that are the subject of premanufacture notices (PMN).  84 Fed. Reg. 13531. The final rule is significant because the 13 chemical substances are not also subject to consent orders.  During the review, EPA identified certain reasonably foreseen conditions of use that it designated as significant new uses in the final SNURs.  The final SNURs effectively prohibit the designated new use unless a person submits a notice to EPA, EPA makes a determination, and it takes any necessary action to mitigate any identified potential risk.  The final rule will become effective on June 4, 2019.  Please see our full memorandum for more information on this final rule.


 

By Lynn L. Bergeson, Richard E. Engler, Ph.D., and Margaret R. Graham

On February 1, 2019, Lynn Vendinello, Acting Director, Chemical Control Division, of the U.S. Environmental Protection Agency’s (EPA) Office of Pollution Prevention and Toxics (OPPT) signed the pre-publication version of a notice announcing that, due to the recent lapse of appropriations and the Agency shutdown, EPA is extending the review periods for all Toxic Substances Control Act (TSCA) Section 5 Premanufacture Notices (PMN), Significant New Use Notices (SNUN), Microbial Commercial Activity Notices (MCAN), and exemption notices that were submitted to the Agency under TSCA Section 5 before December 29, 2018, and for which the review period had not expired as of December 29, 2018.  

Due to a lack of authorized funding, from December 29, 2018, until EPA operations for the TSCA New Chemicals operations fully resumed on January 31, 2019, certain EPA functions were suspended including the processing of submissions made through the Central Data Exchange (CDX), e-PMN, or other methods.  Further, no review work was performed on the TSCA section 5 notifications received by EPA on or before December 29, 2018, and for which the review period had not yet expired as of December 29, 2018.  Consequently, the review period for any TSCA Section 5 notice submitted during the shutdown did not begin until TSCA New Chemical operations fully resumed on January 31, 2019.

EPA states that the duration of the extension period will be a total of 33 days, which is equivalent to the duration of the time period from December 29, 2018 (the date on which certain EPA operations shutdown) and the date on which EPA operations for the TSCA New Chemicals Program fully resumed (January 31, 2019).  The notice states that EPA requires an extension of the review periods to complete its risk assessments, to examine its regulatory options, and to prepare the necessary documents associated with the relevant determination under TSCA Section 5(a)(3).  


 

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

The U.S. Environmental Protection Agency (EPA) issued on October 16, 2018, a proposed rule that would establish significant new use rules (SNUR) under the Toxic Substances Control Act (TSCA) for 13 chemical substances that are the subject of premanufacture notices (PMN).  83 Fed. Reg. 52179.  The proposed rule is significant.  Unlike other recent SNURs (i.e., those enacted since entry into force of amended TSCA), the 13 chemical substances are not also subject to consent orders.  For this reason, the preamble contains novel language to address the new circumstances and legal issues encountered in the proposed rule.  The proposed SNURs would require persons who intend to manufacture (defined by statute to include import) or process any of the 13 chemical substances for an activity that is designated as a significant new use to notify EPA at least 90 days before commencing that activity.  The required notification will initiate EPA’s evaluation of the intended use within the applicable review period.  Persons may not commence the 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.  Comments on the proposed SNURs are due November 15, 2018.

Please see the full memorandum for more information on the proposed rule and an illuminating commentary.


 

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 Carla N. Hutton

The U.S. Environmental Protection Agency (EPA), Environment and Climate Change Canada (ECCC), and Health Canada (HC) have released an educational primer on U.S. and Canadian regulations regarding chemical substances.  EPA states that the purpose of the primer is to compile easy-to-use information for stakeholders potentially regulated under similar U.S. and Canadian regulations -- Significant New Use Rules (SNUR) in the U.S. and Significant New Activity (SNAc) provisions in Canada.  EPA, ECCC, and HC previously collaborated in the implementation of a Regulatory Cooperation Council (RCC) Work Plan on Chemicals Management that focused on SNURs and SNAcs.  The primer states that an overarching issue identified during the roundtable discussions was the need for improved outreach and education, ranging from the basics of the SNUR/SNAc programs to specific requirements for various stakeholders, especially for potentially less-informed stakeholder groups, such as foreign suppliers, and small, niche companies in the U.S. and Canada.  According to EPA, information in the primer will assist the regulated community to determine how to comply and engage their supply chains to help facilitate compliance for meeting SNUR and SNAc requirements.  The primer notes that it does not substitute for any SNUR or SNAc provisions, nor is it a rule itself.  The primer does not impose legally binding requirements on the regulated community or on EPA, ECCC, or HC.


 

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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