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:
- 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;
- 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;
- 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
- 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).
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.
The attorneys, scientists, policy experts, and regulatory advisors of Bergeson & Campbell, P.C. (B&C®), The Acta Group (Acta®), and B&C® Consortia Management, L.L.C. (BCCM) endeavor year-round to keep you informed on key developments as they happen, and prepared for looming changes and deadlines, to help you maintain compliance and competitive advantage as you market your products throughout the world. As the new year begins, we offer you this look back at the top stories of 2016 (as measured by clicks, reads, and shares by readers of our blogs and e-mails), a year that was full of surprises and dramatic shifts -- many of which will play out well into the new year.
June 22, 2016
TSCA Reform: An Analysis of Key Provisions and Fundamental Shifts in the Amended TSCA
September 22, 2016
Proposition 65: OEHHA Adopts Revisions to Its Proposition 65 Warning Regulations
August 8, 2016
TSCA Reform: Proposed Changes to SNUR Procedures Would, Perhaps Inadvertently, Result in Disclosure of CBI to Third Parties/Possible Competitors
June 29, 2016
TSCA Reform: EPA Publishes First Year Implementation Plan
April 8, 2015
K-REACH: List of Priority Existing Substances Submitted for Consultation
December 20, 2016
TSCA: EPA Amends Procedures for TSCA Section 6 Rulemaking
January 6, 2016
EPA Releases Preliminary Risk Assessment for Neonicotinoid Insecticide Imidacloprid
January 8, 2016
EPA Sued Over Guidance Classifying Seeds Coated with Neonicotinoid Insecticides as Treated Articles Exempt from Registration under FIFRA
February 10, 2016
Bayer Announces That It Will Not Submit Voluntary Cancellation Requests for Flubendiamide
October 19, 2016
Brazil Delays Promulgation of Final Industrial Chemicals Regulation
October 6, 2015
EPA Announces Revisions to Its Worker Protection Standard
September 28, 2016
EPA Announces Regulatory Determinations on MCANs and PMNs
January 13, 2016
EPA Denies SDA Nomenclature Petition, But Options for Adding Biobased Sources Remain Open
December 1, 2016
Brexit -- An Overview of Transformative Developments and Their Potential Impact on European Chemical Laws
Top Articles Authored by B&C:
Kathleen M. Roberts, Richard E. Engler, Ph.D., Charles M. Auer, Lynn L. Bergeson, "An Analysis of Section 8 of the New Toxic Substances Control Act," BNA Daily Environment Report, August 9, 2016.
Lynn L. Bergeson, Charles M. Auer, "An Analysis of TSCA Reform Provisions Pertinent to Industrial Biotechnology Stakeholders," Industrial Biotechnology, Volume 12, Issue 4, August 2016.
Charles M. Auer, "Old TSCA, New TSCA, and Chemical Testing," BNA Daily Environment Report, August 16, 2016.
L. Bergeson, B. Auerbach, L. Campbell, T. Backstrom, S. Dolan, J. Vergnes, R. Engler, J. Bultena, K. Baron, C. Auer, "The DNA of the U.S. Regulatory System: Are We Getting It Right for Synthetic Biology?," Woodrow Wilson International Center for Scholars Synthetic Biology Project Report, October 15, 2015.
Coming first quarter 2017 from ABA Books:
Lynn L. Bergeson, Charles M. Auer, New TSCA: A Guide to the Lautenberg Chemical Safety Act and Its Implementation, American Bar Association (2017).
By Lynn L. Bergeson, Charlie M. Auer, and Margaret R. Graham
On October 21, 2016, the U.S. Environmental Protection Agency (EPA) reopened the comment period on a proposed rule revising regulations governing significant new uses (SNU) of chemical substances under the Toxic Substances Control Act (TSCA), per a request from a commenter. EPA states in its Federal Register notice that this request was “reasonable and is therefore reopening the comment period … [for] all interested persons.” The proposed rule would amend the TSCA SNU regulations to align them with revisions to the Occupational Safety and Health Administration’s (OSHA) Hazard Communications Standard (HCS), as occasioned by OSHA's March 2012 final rule modifying the HCS to conform to the United Nations' (U.N.) Globally Harmonized System of Classification and Labelling of Chemicals (GHS), changes to OSHA’s Respiratory Protection Standard, and the National Institute for Occupational Safety and Health (NIOSH) respirator certification requirements pertaining to respiratory protection of workers from exposure to chemicals. The proposed rule would also amend regulations for SNU rules (SNUR) previously proposed and issued and make a “minor” change to reporting requirements for premanufacture notices (PMN) and other TSCA Section 5 notices.
The brief notice reopening the comment period does little to reinforce the magnitude and consequences of these proposed changes. Our memorandum TSCA: Proposed Revisions to Significant New Use Rules Reflect Current Occupational Safety and Health Standards provides a detailed account of the significant and complex issues that these changes raise, briefly reiterated here:
- The challenges in aligning labeling, as well as legal and regulatory ambiguities. EPA has devoted considerable effort to clarifying the application of HCS/GHS requirements to Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) but unresolved issues still remain. The implementation of these revisions will most likely present similar challenges.
- EPA’s use of the hierarchy of controls (HOC) approach in the significant new use provisions, even though Congress did not include this approach in new TSCA. The wisdom of the inclusion of the HOC approach, even though we recognize and appreciate the importance of HOC as an element in a system to manage or eliminate occupational risks, is questionable and inconsistent.
- Whether or not EPA's review considered the possibility that new TSCA may materially impact the content of the proposal. There are signs, such as EPA’s inclusion of old TSCA citations, that point to them not having done this review, and there are no reassurances from EPA that new TSCA’s potential impacts were considered.
Our memorandum TSCA Reform: Proposed Changes to SNUR Procedures Would, Perhaps Inadvertently, Result in Disclosure of CBI to Third Parties/Possible Competitors also brings to light another important legal issue, concerning interesting anomalies that appear in the proposal's discussion of bona fide requests and the disclosure of information potentially considered confidential. EPA proposes to modify the procedures for determining if a specific substance or chemical use is subject to a SNUR when the substance, production volume, or use is claimed as confidential business information (CBI). The source of EPA’s authority to disclose CBI in the ways described in the proposed rule is unclear, as neither old nor new TSCA specifies them, such as the statutory basis and rationale for informing a bona fide intent notice (BFN) submitter of confidential use or production volume conditions. Also, EPA does not justify why disclosure to the BFN submitter is necessary. The current proposed SNUR provides for neither equal disclosure nor equal confidentiality as a result of BFN submission.
Bergeson & Campbell, P.C. (B&C®) Managing Partner Lynn L. Bergeson and Senior Policy and Regulatory Advisor Charles M. Auer have recently published two articles on important issues as related to the amended Toxic Substances Control Act (TSCA):
The concept of “conditions of use” plays an important role in TSCA as amended by the Frank R. Lautenberg Chemical Safety for the 21st Century Act. Conditions of use is a centralizing concept under which the U.S. Environmental Protection Agency (EPA) determines how a chemical is made, processed, used, and disposed. The term is defined in TSCA Section 3 and also appears one or more times in the following Sections: 5, 6, 9, 14, 18, 21, and 26. The term is not used in Sections 4 and 8. B&C’s BNA article explores the use and application of conditions of use under Sections 5 and 6 and provides insights into the implications of what may be its unusual use in Section 5 in comparison to Section 6.
Among its other requirements and authorities, Section 5 of new TSCA generally requires that a company timely submit to EPA a notice of its intent to manufacture or process a new chemical or significant new use (NC/SNU). EPA is then required to conduct a review of the Section 5(a)(1) notice and make a determination on the NC/SNU and take required additional actions. Questions have been raised as to whether the review period is fixed and requires that EPA determinations and actions be completed within that period, or if the statute can be read to permit a more flexible review period along the lines of how it was interpreted and applied in old TSCA with the use of voluntary suspensions. Charles M. Auer and Lynn L. Bergeson’s September ABA article analyzes that question.
Other B&C articles on amended TSCA and other regulatory issues of interest are available on our website.
On July 28, 2016, the U.S. Environmental Protection Agency (EPA) proposed to update the Toxic Substances Control Act (TSCA) Significant New Use Rule (SNUR) procedures. 81 Fed. Reg. 49598. As discussed in our previous memorandum on this proposed rule, Proposed Revisions to Significant New Use Rules Reflect Current Occupational Safety and Health Standards, while some of the proposed changes are not consequential, other changes, such as those related to workplace protections, are more clearly consequential. An issue that was noted but not discussed in detail in our previous memorandum is EPA's proposal to modify the procedures for determining if a specific substance or chemical use is subject to a SNUR when the substance, production volume, or use is claimed as confidential business information (CBI). Specifically, EPA has proposed changes to 40 C.F.R. § 721.11 to address these procedures. Below, we review the current procedures and then address how the proposed language would change those procedures -- changes of which stakeholders should be aware.
To put the changes into context, we first consider the current regulations relating to establishing a bona fide intent to manufacture (bona fide intent) a substance that has confidential identity or confidential conditions in a SNUR. Under the current procedure, determining if a specific substance is listed on the confidential portion of the TSCA Inventory (Inventory) and if the substance is subject to a SNUR requires the submission of a bona fide intent notice (BFN), according to the procedures codified at 40 C.F.R. § 721.11(b). If EPA determines that the submitter has established a bona fide intent, EPA will inform the submitter that the substance is listed on the Inventory and provide "which section in subpart E of this part [40 C.F.R. § 721] applies." This provision would not necessarily reveal any CBI information regarding use or production volume restrictions that are conditions of the SNUR, only the specific 40 C.F.R. § 721 citation.
Whether the identity of a substance is confidential or not, the substance may have SNUR restrictions applied to it that are considered CBI. In particular, production volume and/or specific use(s) may be considered CBI and be part of a SNUR imposed on the substance. The procedures for determining the confidential SNUR restrictions are similar to the procedures to determine if a substance is listed on the confidential portion of the Inventory. It requires submitting a BFN to EPA. In the past, when EPA needed to refer to the procedures for submitting a BFN to determine the confidential SNUR conditions, it referred to the procedures codified at 40 C.F.R. § 721.1725(b)(1). This is in contrast to the BFN procedures for determining if a specific substance is subject to a SNUR listed in 40 C.F.R. § 721.11(b).
To put these changes in context, let us first examine the current procedures for EPA's response to a BFN submitted to determine the CBI provisions of a SNUR. 40 C.F.R. § 721.1725(b)(1)(iv) states:
If EPA determines that the person has a bona fide intent to manufacture, import, or process the chemical substance, EPA will tell the person whether the use for which the person intends to manufacture, import, or process the substance is a significant new use [(SNU)] under paragraph (a)(2)(i) of this section. If EPA tells the person that the intended use is not a significant new use under paragraph (a)(2)(i) of this section, EPA will tell the person what activities would constitute a significant new use under paragraph (a)(2)(ii) of this section.
This means that upon making its determination that a submitter has demonstrated a bona fide intent, EPA either:
- Tells the BFN submitter that the use specified in the BFN is a SNU, in which case the submitter must prepare and submit a Significant New Use Notice (SNUN) at least 90 days prior to manufacturing the substance for the particular use of the substance; or
- Tells the BFN submitter that the use specified in the BFN is not a SNU, in which case EPA tells the submitter what activities would constitute a SNU for the substance.
Note that in the first scenario, where a SNUN is required, EPA does not inform the submitter of the existing confidential SNUR conditions. EPA subsequently makes a determination based on the information in the SNUN when submitted, and informs the SNUN submitter of any restrictions imposed to manage risks associated with the use described in the SNUN. The new restrictions could either be unique to the conditions of the SNUN or could result in a modification of the previously established CBI SNUR restrictions. Also, EPA could amend the confidential portion of the SNUR to include any new permissible activities as a result of the SNUN (e.g., add another CBI use) without informing either manufacturer of the other's confidential SNUR conditions.
In the second scenario, where EPA determines that the BFN submitter's use is not a SNU, EPA informs the BFN submitter of any restrictions associated with that use that might further restrict the BFN submitter or its customers (e.g., the BFN submitter's use is permitted, but that the production volume is capped by the SNUR). As a matter of practice, EPA informs the original submitter that another submitter has demonstrated a bona fide intent, but this practice is not codified in the C.F.R. Furthermore, the original submitter is not informed of the BFN submitter's intent, only that the BFN submitter's use was not a SNU, whereas the BFN submitter knows the heretofore confidential specific use and production volume ceiling (if any). These two outcomes are not aligned. The first scenario is more protective of both entities' CBI. The second scenario provides the BFN submitter some visibility of the original submitter's CBI, but not the reverse.
For example: Manufacturer 1 submits a premanufacture notice for a non-confidential chemical substance to be used as an intermediate to manufacture a pesticide and claims the use as confidential (with a generic use of "intermediate"). EPA makes a determination that the use specified in the PMN does not present an unreasonable risk to health or the environment, but other uses may present issues, so EPA imposes a SNUR invoking 40 C.F.R. § 721.80(j) limiting its use to the use listed in the PMN (intermediate to manufacture a pesticide). Manufacturer 1 then commences commercially manufacturing the substance and files a Notice of Commencement (NOC), placing the substance on the public portion of the Inventory. Some time later, Manufacturer 2 seeks to use the same substance as an intermediate to manufacture an anti-oxidant lubrication additive. Manufacturer 2 submits a BFN and EPA informs Manufacturer 2 that its use is a SNU. Manufacturer 2 then submits a SNUN for its use, also claiming the specific use as confidential and listing "intermediate" as the generic use. EPA evaluates the SNUN and determines that this particular use is not likely to present unreasonable risk to health or the environment, but other uses may present issues, so EPA adds the new use to the confidential uses permitted for the substance, but leaves the other SNUR provisions in place and neither manufacturer knows the specific use of the other.
We note that manufacturers must communicate SNUR restrictions to their customers. 40 C.F.R. § 721.5 requires that to avoid submitting a SNUN, each manufacturer must provide the SNUR conditions to its customer(s). 40 C.F.R. § 721.5(a)(2) requires that "[a] person who intends to manufacture, import, or process for commercial purposes a chemical substance [with a SNUR], and intends to distribute the substance in commerce" must submit a SNUN. Most manufacturers avoid this SNUN requirement by taking advantage of the provisions of 40 C.F.R. § 721.5(a)(2)(i) that state that a SNUN is not required if the manufacturer can document:
That the person [manufacturer] has notified the recipient [customer], in writing, of the specific section in subpart E of this part which identifies the substance and its designated significant new uses.
In the example above, each manufacturer notifies its own customers of the appropriate C.F.R. citation and SNUR restrictions (Manufacturer 1 informs its customer that the use is limited to use as an intermediate for a pesticide; Manufacturer 2 informs its customer that the use is limited to use as an intermediate for an antioxidant). The customers of each manufacturer remain in compliance with the SNUR and 40 C.F.R. § 721.5, assuming each customer restricts its use based on the information provided by the separate manufacturers. In this scenario, all four parties (both manufacturers and both customers) can be in compliance without EPA disclosing the confidential use of one manufacturer to the other.
EPA has proposed incorporating the BFN procedures for determining whether an activity is a SNU under the confidential provisions of a SNUR into 40 C.F.R. § 721.11(a) (the proposed key changes are emphasized):
A person who intends to manufacture or process a chemical substance which is subject to a significant new use rule in subpart E of this part may ask EPA whether the substance or a proposed use is subject to the requirements of this part if that substance is described by a generic chemical name or if the significant new use is confidential and therefore not described specifically in the rule. EPA will answer such an inquiry only if EPA determines that the person has a bona fide intent to manufacture or process the chemical substance for commercial purposes.
This change is innocuous. It simply incorporates the two BFN procedures into a single paragraph. EPA's proposal on procedures for its response to such a BFN, proposed to be codified at 40 C.F.R. § 721.11(e) alters procedures for how EPA responds (again, proposed key changes emphasized):
If the manufacturer or processor has shown a bona fide intent to manufacture or process the substance and has provided sufficient unambiguous chemical identity information to enable EPA to make a conclusive determination as to the identity of the substance, EPA will inform the manufacturer or processor [the BFN submitter] whether the chemical substance is subject to this part and, if so, which section in subpart E of this part applies, and identify any confidential significant new use designations.
Under the proposed rule, once a submitter has established a bona fide intent, EPA will disclose to the BFN submitter any confidential significant new use designations, including specific use and production volume restrictions, whether or not those restrictions are relevant to or would limit the BFN submitter's commercial activity as proposed in the BFN. As proposed by EPA, this disclosure would be made to the BFN submitter without regard for the existing CBI claims on the information, and without informing the original entity holding the CBI claim before or after making this disclosure.
Importantly, this change means that EPA is switching from a presumption of protecting CBI in the SNUR to actively informing later submitters of information proprietary to the original submitter. While 40 C.F.R. § 721.11(f) states that informing later submitters of SNUR restrictions "will not be considered public disclosure of [CBI] under Section 14," it is an unavoidable fact that EPA's proposed approach involves disclosure of CBI to an additional party, one that could be a competitor to the original submitter (both are, after all, manufacturing the same substance), a fact pattern that is very likely to be of considerable concern to the original submitter.
We do not read provisions in either old or new TSCA to authorize EPA to disclose CBI in the way that is proposed in this notice. The CBI SNUR requirements do not fall into any of the information types discussed under Section 14(b) of new TSCA that concerns information not protected from disclosure. The BFN submitter cannot be considered to have official duties or needs related to those discussed at Section 14(d) of new TSCA, the provision that allows CBI disclosure under certain circumstances. The BFN submitter only needs to know if the proposed use is a SNU or not. If EPA informs the BFN submitter that the proposed use is not a SNU, the BFN submitter is effectively bound to the use terms laid out in the BFN and would need to submit a new BFN if other uses or changes in the initially proposed use are contemplated.
Based on the foregoing, with the proposed language, the second submitter is unavoidably privy to the CBI claimed by the first submitter, but there is no provision in the C.F.R to inform the first submitter of the conditions sought by the second submitter. This is in contrast to the provisions in 40 C.F.R. § 720.25(b)(6) in which the original submitter is notified if and when a second entity has demonstrated a bona fide intent that is listed on the CBI portion of the Inventory. Both the original submitter and the BFN submitter are informed that another entity is manufacturing the substance for a TSCA purpose.
EPA must provide the statutory basis and rationale for informing a BFN submitter of confidential use or production volume conditions. If EPA can provide the statutory basis for such disclosure, EPA must also explain why it must disclose such information to the BFN submitter. If EPA can somehow justify disclosing the CBI SNUR conditions, it should codify its obligation to notify the original CBI submitter that such disclosure has occurred. The current proposed SNUR provides for neither equal disclosure nor equal confidentiality as a result of BFN submission.
TSCA stakeholders should carefully consider commenting on the changes to 40 C.F.R. § 721.11 to be sure that EPA is acting within its statutory authority, justifying why disclosure is necessary, and providing for notification of the original CBI holder. While the consequences of these proposed provisions may be inadvertent, the proposed rule either needs to be withdrawn and re-proposed to reflect the law, or rationalized in a way that our careful reading of TSCA does not allow.