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).
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 and Margaret R. Graham
On October 17, 2018, the Trump Administration published its Unified Agenda of Regulatory and Deregulatory Actions (Regulatory Agenda). There are many interesting entries, some of which are flagged here.
Not surprisingly, the U.S. Environmental Protection Agency (EPA) listed implementing Toxic Substances Control Act (TSCA) amendments to enhance public health and chemical safety as one of its top priorities. According to EPA, the amendments to TSCA that were enacted in June 2016 require EPA “to evaluate existing chemicals on the basis of the health risks they pose -- including risks to vulnerable groups and to workers who may use chemicals daily as part of their jobs.” If unreasonable risks are found, EPA must then take steps to eliminate these risks but, “during the risk management phase, EPA must balance the risk management decision with potential disruption based on compliance to the national economy, national security, or critical infrastructure.” The following TSCA items were included.
The rules in the proposed rule stage are:
- Microorganisms: General Exemptions From Reporting Requirements; Revisions of Recipient Organisms Eligible for Tier I and Tier II Exemptions, 2070-AJ65. The Regulatory Agenda states that EPA is still 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 Section 5(h)(4) exemption. EPA was scheduled to issue a proposed rule by October 2018.
- Long-Chain Perfluoroalkyl Carboxylate (LCPFAC) and Perfluoroalkyl Sulfonate Chemical Substances; Significant New Use Rule (SNUR), 2070-AJ99. The Regulatory Agenda states that EPA is developing a supplemental proposal for part of a SNUR under TSCA Section 5(a)(2) for LCPFAC chemical substances to make inapplicable the exemption for persons who import a subset of LCPFAC chemical substances as part of certain articles. This rule was scheduled to be proposed by October 2018 and issued in final by November 2019. EPA’s initial proposed rule was issued on January 21, 2015.
- 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), 2070-AK21. The Regulatory Agenda states that EPA is developing a proposed rule that establishes 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 is scheduled to issue the proposed rule by January 2019 and the final rule by December 2019, as TSCA directs a final rule to be issued by December 16, 2019.
- TSCA Chemical Data Reporting Revisions and Small Manufacturer Definition Update for Reporting and Recordkeeping Requirements Under TSCA Section 8(a), 2070-AK33. The Regulatory Agenda states that before the next Chemical Data Reporting (CDR) period of 2020, EPA intends to revise the reporting requirements to better align with new statutory requirements resulting from TSCA, as amended, to address submitters' feedback following the 2016 submission period, and may consider reporting requirements for inorganic byproducts. EPA is also proposing amendments to the size standards for small manufacturers, which impacts certain reporting and recordkeeping requirements for TSCA Section 8(a) rules, including CDR. EPA is scheduled to issue the proposed rule by December 2018 and the final rule by October 2019.
- Regulation of Persistent, Bioaccumulative, and Toxic Chemicals Under TSCA Section 6(h), 2070-AK34. The Regulatory Agenda states that EPA is developing a proposed rule to implement TSCA Section 6(h), as amended, which directs EPA to issue regulations for certain persistent, bioaccumulative, and toxic (PBT) chemical substances that were identified in the 2014 update of the TSCA Work Plan. TSCA directs these regulations to be proposed by June 22, 2019, and issued in final form no later than 18 months after proposal. According to the Regulatory Agenda, EPA will issue a proposed rule by June 2019.
- Technical Issues; Formaldehyde Emission Standards for Composite Wood Products, 2070-AK47. EPA is proposing to amend the regulations promulgated in a final rule published on December 12, 2016, concerning formaldehyde emission standards for composite wood products, specifically to address certain technical issues and further align the final rule requirements with the California Air Resources Board (CARB) Airborne Toxic Control Measures (ATCM) Phase II program. EPA issued the proposed rule on November 1, 2018, in the Federal Register; comments are due by December 3, 2018. EPA expects to issue a final rule by March 2019.
The rules in the final rule stage are:
- Review of Dust-Lead Hazard Standards and the Definition of Lead-Based Paint, 2070-AJ82. EPA issued a proposed rule on July 2, 2018, that would lower the current dust-lead hazard standards (DLHS) from 40 mg/ft2 and 250 mg/ft2 to 10 mg/ft2 and 100 mg/ft2 on floors and window sills, respectively, per a final decision of the U.S. Court of Appeals for the Ninth Circuit. The Regulatory Agenda states that while EPA has proposed standards of 10 mg/ft2 and 100 mg/ft2 for floors and window sills respectively, EPA encouraged public comment on the full range of candidate standards analyzed as alternatives to the proposal, including the option not to change the current standard or to reduce the floor dust standard but leave the sill dust standard unchanged, since reducing floor dust lead has the greatest impact on children's health. EPA is scheduled to issue the final rule by June 2019. More information on the proposed rule is available in our memorandum “Recent Federal Developments -- July 2018.”
- SNUR for Toluene Diisocyanates (TDI) and Related Compounds, 2070-AJ91. The Regulatory Agenda states that EPA is preparing the final version of a proposed SNUR issued on January 15, 2015, under TSCA Section 5(a)(2) for 2,4-toluene diisocyanate, 2,6-toluene diisocyanate, toluene diisocyanate unspecified isomers, and related compounds; and that there are no changes in the chemicals subject to the SNUR between the proposed and final rule. EPA is scheduled to issue the final rule in November 2018.
- Significant New Uses of Chemical Substances; Updates to the Hazard Communication Program and Regulatory Framework; Minor Amendments to Reporting Requirements for Premanufacture Notices, 2070-AJ94. On July 28, 2016, EPA issued a rule proposing changes to the applicable significant new uses of chemical substances regulations at 40 C.F.R. Part 721 to align EPA's regulations, where possible, with the final revisions to the U.S. Occupational Safety and Health Administration (OSHA) Hazard Communications Standard. The Regulatory Agenda states that EPA is reviewing the comments received and is planning to issue a final rule in February 2019.
- Certain Nonylphenols and Nonylphenol Ethoxylates; SNUR, 2070-AJ96. The Regulatory Agenda states that EPA is reviewing the comments received on the proposed SNUR issued on October 1, 2014, for certain chemical substances commonly known as nonylphenols (NP) and nonylphenol ethoxylates (NPE) and is planning to issue a final rule in September 2019. More information on the proposed SNUR is available in our memorandum “EPA Proposes SNUR for Nonylphenols and Nonylphenol Ethoxylates.”
- Methylene Chloride; Rulemaking Under TSCA Section 6(a), 2070-AK07. The Regulatory Agenda states that EPA is scheduled to issue the final rule prohibiting the consumer and commercial paint stripping uses for methylene chloride by December 2018. In a press release issued on May 10, 2018, EPA stated that it will not re-evaluate the paint stripping uses of methylene chloride and will rely on its previous risk assessments. See our memorandum “EPA Will Send Final Methylene Chloride Rule to OMB ‘Shortly’” for more information on the proposed rule.
- Asbestos; SNUR, 2070-AK45. The Regulatory Agenda states that EPA’s proposed SNUR under TSCA Section 5(a)(2) for certain uses of asbestos that are no longer in use in the United States is scheduled to be issued in final by January 2019. The proposed SNUR was issued on June 11, 2018, and the comment period ended on August 10, 2018. More information on the proposed rule is available in our memorandum “Monthly Update for June 2018.”
The following Long-Term Action was also listed:
- N-Methylpyrrolidone (NMP); Regulation of Certain Uses Under TSCA Section 6(a), RIN 2070-AK46. The Regulatory Agenda states that EPA’s two co-proposals for NMP that were proposed on January 19, 2017 (as part of RIN 2070-AK07), will be issued in final with a future date “To Be Determined.” The first co-proposal would prohibit the manufacture, processing, and distribution in commerce of NMP for all consumer and most commercial paint and coating removal and the use of NMP for most commercial paint and coating removal. The second co-proposal would require commercial users of NMP for paint and coating removal to establish a worker protection program and not use paint and coating removal products that contain greater than 35 percent NMP by weight, with certain exceptions; and require processors of products containing NMP for paint and coating removal to reformulate products such that they do not exceed 35 percent NMP by weight, to identify gloves that provide effective protection for the formulation, and to provide warnings and instructions on any paint and coating removal products containing NMP. For more information on the proposed rule, please see our memorandum "Monthly Update for February 2017."
For information on the TSCA items included in the Spring 2018 Regulatory Agenda, please see our blog item “EPA’s Spring 2018 Unified Agenda and Regulatory Plan Includes TSCA Rulemakings.”
By Lynn L. Bergeson and Carla N. Hutton
On August 27, 2018, the U.S. Environmental Protection Agency (EPA) issued two direct final rules promulgating significant new use rules (SNUR) under the Toxic Substances Control Act (TSCA). The first direct final rule promulgates SNURs for ten chemical substances that were the subject of premanufacture notices (PMN). 83 Fed. Reg. 43527. The second direct final rule promulgates SNURs for 19 chemical substances that were the subject of PMNs. 83 Fed. Reg. 43538. In each rule, EPA notes that the chemical substances are subject to consent orders issued by EPA pursuant to TSCA Section 5(e). The direct final rules require persons who intend to manufacture (defined by statute to include import) or process any of these 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 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. Both direct final rules will be effective on October 26, 2018. Written adverse comments on one or more of the SNURs must be received by September 26, 2018. If EPA receives written adverse comments, on one or more of these SNURs before September 26, 2018, EPA will withdraw the relevant sections of the direct final rules before their effective date. In addition to the direct final rules, EPA published proposed rules for both the direct final rules. 83 Fed. Reg. 43606, 83 Fed. Reg. 43607. Comments on the proposed rules are due September 26, 2018.
By Lynn L. Bergeson and Margaret R. Graham
On June 1, 2018, the U.S. Environmental Protection Agency (EPA) released the much anticipated first ten problem formulation documents; its systematic review approach document; and a significant new use rule (SNUR) proposal enabling it to prevent new uses of asbestos for public comment. Links and short summaries are provided below.
EPA states that the problem formulation documents refine the conditions of use, exposures, and hazards presented in the scope of the risk evaluations for the first ten chemicals to be evaluated under the Toxic Substances Control Act (TSCA) and present refined conceptual models and analysis plans that describe how EPA expects to evaluate the risks and that they are an important interim step prior to completing and publishing the final risk evaluations by December 2019. Comments on the problem formulation documents will be due 45 days after these documents are published in the Federal Register. The problem formulation documents are:
- 1-Bromopropane (1-BP);
- Carbon Tetrachloride;
- Cyclic Aliphatic Bromide Cluster (HBCD Cluster);
- Methylene Chloride;
- N-Methylpyrrolidone (NMP);
- Pigment Violet 29; and
- Trichloroethylene (TCE).
EPA states the systematic review approach document will guide its selection and review of studies in addition to providing the public with continued transparency regarding how the Agency plans to evaluate scientific information. Comments will be due 45 days after publication in the Federal Register. Also included on the systematic review web page is EPA’s Response to Public Comments Related to the Supplemental Files Supporting the TSCA Scope Documents for the First Ten Risk Evaluations.
For asbestos, EPA is proposing an asbestos SNUR for certain uses of asbestos (including asbestos-containing goods) that would require manufacturers and importers to receive EPA approval before starting or resuming manufacturing, and importing or processing of asbestos. EPA states that this review process, the first such action on asbestos ever proposed, would provide EPA with the opportunity to evaluate the intended use of asbestos and, when necessary, take action to prohibit or limit the use. Comments will be due 60 days after publication in the Federal Register.
More information on the first ten chemical evaluations is available on our blog. A more detailed analysis will be available next week on our regulatory developments webpage.
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 Richard E. Engler, Ph.D., Lynn L. Bergeson, Kathleen M. Roberts, and Lauren M. Graham, Ph.D.
On December 6, 2017, the U.S. Environmental Protection Agency’s (EPA) Office of Pollution Prevention and Toxics (OPPT) convened a much anticipated public meeting on implementing changes to the new chemicals review program under the amended Toxic Substances Control Act (TSCA). EPA offered brief prepared remarks and previously solicited questions from stakeholders. Stakeholders expressed their appreciation to EPA for developing the draft Points to Consider and related documents made available in advance of the meeting, and for OPPT’s continuing interest on new chemical issues. For more information, see our blog “EPA Posts Agenda and Other Meeting Materials for December 6, 2017, New Chemicals Review Program Implementation Meeting.” Below are some key takeaways regarding the meeting as related to EPA’s presentations and input from industry and non-governmental organizations (NGO).
Conditions of Use, SNURs, and PMNs: EPA stated that one of its main concerns is when EPA does not identify unreasonable risk for intended use, but nonetheless has concerns with reasonably foreseen conditions of use. EPA stated that it will assess whether those concerns can be addressed through significant new use rules (SNUR) that it would promulgate prior to making its Section 5 finding. EPA stated that, in identifying reasonably foreseeable uses, it will rely on knowledge, experience, and facts to support what is foreseen, not simply what is possible. Several commenters requested clarification and examples on the information that will support such identifications. This is plainly an area of intense interest and on which EPA pledged to clarify.
EPA confirmed that the SNUR would mirror the premanufacture notice (PMN) in a way that would clearly state what deviations would be permitted to ensure protections for portions of the PMN about which EPA had identified concerns. In response to a direct question, Jeff Morris, Ph.D., OPPT Director, confirmed that he personally is looking at each new chemical notification decision to ensure a consistent and coherent approach to chemical reviews. Dr. Morris assured stakeholders that his engagement would not slow down the PMN review process.
NGO groups, that were ably represented at the meeting, expressed disappointment that they were not a part of the pilot testing component of the new chemicals Points to Consider document. OPPT clarified that the purpose of the pilot was to have parties who are actually preparing PMNs pilot use of the document while preparing PMNs and that as a result, non-PMN submitters were not a part of the pilot. Following a request from several NGOs, EPA stated that it would of course make the original and redline versions of the Points to Consider document publicly available to ensure full transparency. Several NGOs also voiced concern with the delay of EPA getting PMN information posted online. Commenters noted the need for access to more content related to the new chemicals review, such as detailed PMN determinations, as the determinations that are publicly available at this point are boilerplate. Interestingly, concerns were expressed on issues not germane to the workshop, such as existing and accidental releases of chemicals (not related to TSCA).
Of the parties that weighed in on the issue, industry representatives who addressed the issue were supportive of using SNURs to cover reasonably foreseeable conditions of use that are not reflected in the submitted PMNs. Some NGOs were supportive of the use of SNURs to reduce consent orders, while others stated that SNURs are not an adequate substitute for consent orders and that Congress intended for Section 5(e) orders to come first and to trigger SNURs. The concern over the use of SNURs rather than consent orders may relate to a concern of chemicals being introduced prior to the SNUR being published in final. Industry representatives also suggested that EPA seek to scale its information needs appropriately. For instance, less detailed exposure information should be required for EPA to determine that it has sufficient information on a low hazard chemical. Similarly, EPA should adjust the hazard profile requirements for a chemical with low exposure.
Chemical Categories: EPA reviewed the ongoing effort to develop four new chemical categories that could be used in future new chemical reviews. These are:
- Lung Effects Categories: Polycationic substances (cationic binding); general surfactants; waterproofing agents; and insoluble polymer lung overload;
- Photo-Acid Generators (PAG) Category;
- Tracer Chemical; and
- Perfluorinated Chemicals.
EPA asked for input and ideas on how to move forward with chemical categories -- either by updating existing categories or reviewing internal data to identify new categories -- and how the information should be presented (e.g., to publish separately or together in one document).
OSHA Focus: On behalf of the TSCA New Chemicals Coalition (TSCA NCC), Richard E. Engler, Ph.D., Bergeson & Campbell, P.C., provided comments that included feedback to EPA that it needs to develop a consultation process with the U.S. Occupational Safety and Health Administration (OSHA) per the Section 5(f) legislative language. Dr. Engler suggested that EPA’s assessments could be communicated to submitters and OSHA to inform both on the endpoints of concern and EPA’s assessments of safe exposure limits. In this way, employers are obligated under the Occupational Safety and Health Act to assess hazards and exposures, provide information to workers, and ensure that exposures are controlled under OSHA’s authority, thereby satisfying EPA’s obligation to regulate “to the extent necessary” to protect such workers.
Sustainable Futures Program: EPA asked for input as to whether it should continue the Sustainable Futures Program. Some commenters supported the Sustainable Futures Program; no commenters spoke against it.
The presentations from the meeting are listed below and available online:
- New Chemical Review under Amended TSCA -- Jeff Morris, Ph.D., Director, OPPT
- Points to Consider (PtC) When Preparing TSCA New Chemical Notifications -- David A. Tobias, Ph.D., Risk Assessment Division, OPPT
- New Chemicals Decision Guidelines Manual Detailed Outline
- Chemical Categories -- Tala R. Henry, Ph.D., Director, Risk Assessment Division, OPPT
- Other Advance Questions -- Tanya Hodge Mottley, Acting Deputy Director of Programs, OPPT
EPA’s next public meeting on TSCA’s implementation of Existing Chemicals Prioritization is coming up on December 11, 2017. More information on this upcoming meeting is available on our blog under key phrase public meeting.
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.