Bergeson & Campbell, P.C. (B&C®) is a Washington, D.C. law firm providing chemical and chemical product stakeholders unparalleled experience, judgment, and excellence in matters relating to TSCA, and other global chemical management programs.

By Lynn L. Bergeson and Carla N. Hutton
 
The New York State Department of Environmental Conservation (NYSDEC) will hold a virtual public meeting on May 26, 2021, at 1:00 p.m. (EDT). NYSDEC will present topics for discussion related to implementation of the recently enacted law, which created ingredient disclosure requirements for children’s products.  Title 9 of Article 37 of the Environmental Conservation Law (ECL) establishes an ingredient disclosure program and prohibits certain chemicals in children’s products. ECL Article 37 instructs NYSDEC to promulgate lists of chemicals of concern and high-priority chemicals by March 1, 2022. It also prohibits the sale of children’s products containing benzene, asbestos, or tris(1,3-dichloro-2-propyl) phosphate effective January 1, 2023. NYSDEC states that it is in the process of developing a rule to implement portions of the law. NYSDEC expects the rule to address the specific product categories that are covered, what chemicals and supporting information must be disclosed, details on how to obtain a waiver from reporting or the sales prohibition, and the fees associated with reporting and applying for a waiver. NYSDEC notes that it will hold a formal public comment period on the proposed rule at a later date. Stakeholders must register to attend the virtual public meeting.


 

By Lynn L. Bergeson and Carla N. Hutton

On April 29, 2021, the U.S. Environmental Protection Agency (EPA) announced the release of a list of 390 chemicals that it states are “expected to lose their confidential status and move to the public portion of the Toxic Substances Control Act (TSCA) Inventory, furthering the agency’s commitment to data transparency.”  According to EPA, the specific identities of these chemicals were reported as non-confidential during Chemical Data Reporting (CDR) cycles from the 2012, 2016, and/or 2020 reporting periods.  In accordance with the CDR rule and with TSCA Sections 8 and 14, EPA intends to update the TSCA Inventory listings for these chemicals to list the specific chemical identities on the public portion of the Inventory.  Stakeholders should check the list of substances and ensure that none of those substances is of critical importance to maintain confidential status.  Stakeholders with interest, questions, or concerns about this change in confidential status may contact the listed EPA staff no later than May 14, 2021.  EPA expects to include the specific chemical identities of these 390 chemicals in the next routine publication of the public TSCA Inventory, anticipated in late summer 2021.


 

By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) published a Federal Register notice on April 28, 2021, announcing a 30-day comment period on the Toxic Substances Control Act (TSCA) Interagency Testing Committee’s (ITC) revisions to the Priority Testing List.  86 Fed. Reg. 22414.  In the 74th ITC Report, ITC revised the TSCA Section 4(e) Priority Testing List by adding the following 15 high-priority substances designated pursuant to TSCA Section 6(b) and 24 organohalogen flame retardants:

Chemical Substance Chemical Abstracts Service Registry Number
High-Priority Substances
1,3-Butadiene 106-99-0
Butyl benzyl phthalate (BBP) - 1,2-Benzene- dicarboxylic acid, 1- butyl 2(phenylmethyl) ester 85-68-7
Dibutyl phthalate (DBP) (1,2-Benzene- dicarboxylic acid, 1,2- dibutyl ester) 84-74-2
o-Dichlorobenzene 95-50-1
p-Dichlorobenzene 106-46-7
trans-1,2- Dichloroethylene 156-60-5
1,2-Dichloropropane 78-87-5
Dicyclohexyl phthalate 84-61-7
Di-ethylhexyl phthalate (DEHP) - (1,2-Benzene- dicarboxylic acid, 1,2- bis(2- ethylhexyl) ester) 117-81-7
Di-isobutyl phthalate (DIBP) - (1,2-Benzene- dicarboxylic acid, 1,2- bis-(2methylpropyl) ester) 84-69-5
Formaldehyde 50-00-0
1,3,4,6,7,8-Hexahydro-4,6,6,7,8,8-hexamethylcyclopenta [g]-2-benzopyran (HHCB) 1222-05-5
Phthalic anhydride 85-44-9
4,4'-(1-Methylethylidene)bis[2, 6-dibromophenol] (TBBPA) 79-94-7
1,1,2-Trichloroethane 79-00-5
Organohalogen Flame Retardants
Bis(hexachlorocyclopentadieno)cyclooctane 13560-89-9
1,2-Bis(2,4,6-tribromophenoxy)ethane 37853-59-1
1,1'-Ethane-1,2-diylbis(pentabromobenzene) 84852-53-9
2-(2-Hydroxyethoxy)ethyl 2-hydroxypropyl 3,4,5,6-tetrabromophthalate 20566-35-2
2,2'-[(1-Methylethylidene)bis[(2,6-dibromo-4,1-
phenylene)oxymethylene]]bis[oxirane]
3072-84-2
Mixture of chlorinated linear alkanes C14-17 with 45-52 % chlorine 85535-85-9
N,N-Ethylene-bis(tetrabromophthalimide) 32588-76-4
Pentabromochlorocyclohexane 87-84-3
(Pentabromophenyl)methyl acrylate 59447-55-1
Pentabromotoluene 87-83-2
Perbromo-1,4-diphenoxybenzene 58965-66-5
Phosphonic acid, (2-chloroethyl)-, bis(2-chloroethyl) ester 6294-34-4
Propanoic acid, 2-bromo-, methyl ester 5445-17-0
Tetrabromobisphenol A-bis(2,3-dibromopropyl ether) 21850-44-2
Tetrabromobisphenol A bis(2-hydroxyethyl) ether 4162-45-2
Tetrabromobisphenol A diallyl ether 25327-89-3
Tetrabromobisphenol A dimethyl ether 37853-61-5
2,4,6-Tribromoaniline 147-82-0
1,3,5-Tribromo-2-(prop-2-en-1-yloxy)benzene 3278-89-5
Tris(2-chloroethyl) phosphite 140-08-9
Tris(2,3-dibromopropyl) phosphate 126-72-7
1,3,5-Tris(2,3-dibromopropyl)-1,3,5-triazine-2,4,6(1H,3H,5H)-trione 52434-90-9
Tris(tribromoneopentyl)phosphate 19186-97-1
2,4,6-Tris-(2,4,6-tribromophenoxy)-1,3,5-triazine 25713-60-4

ITC requests that EPA add these chemical substances and the other five high-priority substances and six organohalogen flame retardants currently on the Priority Testing List to 40 C.F.R. Section 716.120(a), the list of substances subject to the TSCA Section 8(d) Health and Safety Data Reporting rule (40 C.F.R. Part 716).  The rule requires manufacturers (including importers) of chemical substances and mixtures added to the Health and Safety Data Reporting rule to submit lists and copies of unpublished health and safety studies to EPA.  Comments are due May 28, 2021.
 
EPA notes that in addition to the chemical substances being added to the Priority Testing List in the 74th ITC Report, the Priority Testing List includes two alkylphenols, 45 High Production Volume (HPV) Challenge Program orphan chemicals, cadmium, a category of cadmium compounds, six non-phthalate plasticizers, 25 phosphate ester flame retardants, two other flame retardants, nine chemicals to which children living near hazardous waste sites may be exposed, and 19 diisocyanates and related compounds.


 

By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) announced on April 8, 2021, that it is releasing an updated toxicity assessment for perfluorobutane sulfonic acid (PFBS), which is a member of the group of per- and polyfluoroalkyl substances (PFAS).  EPA states that this PFBS assessment is part of its commitment to restore scientific integrity to all of the Agency’s actions and increase the amount of research and information available to the public on PFAS.  According to EPA’s announcement, “EPA, federal agencies, states, tribes, and local communities can use the PFBS toxicity assessment, along with specific exposure and other relevant information, to determine if and when it is necessary to take action to address potential health risks associated with human exposures to PFBS under appropriate regulations and statutes.”  EPA notes that the updated assessment “has gone through all appropriate reviews, includes input EPA received from external peer review, upholds the tenants of scientific integrity, was authored by expert career scientists in EPA’s Office of Research and Development, and has not been compromised by political staff -- these were all issues with a version of the assessment that was posted during the previous administration.  The release of today’s PFBS assessment upholds the integrity of EPA’s science, which EPA, states, tribes, and more rely on to make decisions that protect the health of their communities.”
 
According to EPA’s fact sheet on the toxicity assessment, PFBS is a replacement chemical for perfluorooctanesulfonic acid (PFOS), a PFAS that was voluntarily phased out by the primary U.S. manufacturer by 2002.  PFBS has been identified in the environment and consumer products, including surface water, wastewater, drinking water, dust, carpeting and carpet cleaners, and floor wax.  The fact sheet states that the PFBS toxicity assessment is comparable to assessments developed under EPA’s Integrated Risk Information System (IRIS) and Provisional Peer-Reviewed Toxicity Value (PPRTV) Programs in that it provides hazard identification, dose-response information, and toxicity values.  EPA will continue to work with state, tribal, and local partners to provide technical assistance as they consider the final PFBS toxicity values in relevant exposure scenarios.  The fact sheet notes that at this time, EPA does not plan to issue a regulation for PFBS.


 

By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) announced on April 1, 2021, that it is extending the public comment period for a manufacturer-requested risk evaluation of octahydro-tetramethyl-naphthalenyl-ethanone (OTNE), a category of chemical substances consisting of four inseparable individual isomers.  As reported in our February 18, 2021, blog item, EPA notes that two chemicals in the OTNE category are considered persistent, bioaccumulative, and toxic (PBT) chemicals under the Toxic Substances Control Act (TSCA), “meaning they are toxic, can remain in the environment for long periods of time, and can build up or accumulate in the body.”  EPA “welcomes all public comments,” particularly on the following:

  • Any information not included in the manufacturer request that commenters believe EPA would need to conduct a risk evaluation;
  • Additional conditions of use EPA is proposing to include in the risk evaluation; and
  • Information on conditions of use not included in the manufacturer request or in the additional conditions of use EPA proposes to include in the risk evaluation, specifically the inclusion of any additional conditions of use and potentially exposed or susceptible subpopulations.  EPA states that it “is in the process of broadly re-examining how it intends to implement these and other provisions of the amended [TSCA] including determining how new executive orders will be addressed.  This process would benefit greatly from stakeholder feedback.”

Comments were due April 5, 2021, but EPA is extending the comment period an additional 30 days.  After the comment period closes, EPA will review the comments and either grant or deny the request to conduct a risk evaluation within 60 days.  If EPA grants the request, the manufacturers would be responsible for half the cost of the risk evaluation.  International Flavors and Fragrances, Inc., Privi Organics USA Corporation, and DRT America, Inc. formally requested the risk evaluation through the OTNE Consortium managed by B&C® Consortia Management, L.L.C. (BCCM).


 

This week's All Things Chemical™ Podcast will be of interest to readers of the TSCAblog™. A brief description of the episode written by Lynn L. Bergeson is below.

This week I sat down with Karin Baron, Senior Regulatory Consultant to B&C and our affiliated consultancy, The Acta Group, to discuss the European Union’s (EU) Commission Regulation issued last June relating to the completion of safety data sheets (SDS).  As listeners know, SDSs are critically important commercial documents that describe the hazards identified with a particular chemical product or mixture as it makes  its way in commerce.  While this is an EU rule, Karin explains why the new regulation has important consequences for U.S. businesses.

ALL MATERIALS IN THIS PODCAST ARE PROVIDED SOLELY FOR INFORMATIONAL  AND ENTERTAINMENT PURPOSES. THE MATERIALS ARE NOT INTENDED TO CONSTITUTE LEGAL ADVICE OR THE PROVISION OF LEGAL SERVICES. ALL LEGAL QUESTIONS SHOULD BE ANSWERED DIRECTLY BY A LICENSED ATTORNEY PRACTICING IN THE APPLICABLE AREA OF LAW.

©2021 Bergeson & Campbell, P.C.  All Rights Reserved


 

By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) announced on March 15, 2021, a settlement requiring Western Reserve Chemical Corp. (WRCC) in Stow, Ohio, to pay a $357,000 civil penalty for violations of chemical data reporting regulations under the Toxic Substances Control Act (TSCA).  EPA claims that from 2012 to 2015, WRCC failed to submit data reports for 18 chemical substances as required by TSCA.  According to EPA, WRCC imports various chemicals for businesses that formulate rubber, plastics, adhesives, sealants, and coatings.  EPA states that the alleged violations “presented a potential harm to the Agency’s ability to maintain accurate and updated information regarding commercially-produced chemicals.”  EPA’s consent agreement and final order with WRCC resolves the alleged violations and requires the payment of a $357,000 civil penalty in installments within 18 months.
 
Information about chemical reporting is available on the TSCA Chemical Data Reporting web page.  EPA notes that the chemical data reports for 2016 to 2019 were due from industry manufacturers by January 29, 2021.  The Substance Registry Services web page offers a search function to find out if a specific chemical is on the TSCA Inventory.


 

By Lynn L. Bergeson and Carla N. Hutton
 
As reported in our March 9, 2021, blog item, the U.S. Environmental Protection Agency (EPA) announced on March 8, 2021, that “in accordance with Biden-Harris Administration executive orders and directives,” it is asking for additional public input on five final rules for persistent, bioaccumulative, and toxic (PBT) chemicals issued on January 6, 2021, under the Toxic Substances Control Act (TSCA).  On March 16, 2021, EPA announced that comments on the final rules are due May 17, 202186 Fed. Reg. 14398.  EPA seeks comment on:

  • Whether the rules sufficiently reduce exposure to these chemicals, including exposures to potentially exposed or susceptible subpopulations and the environment;
  • Newly raised compliance issues associated with the final rule on phenol, isopropylated phosphate (3:1) (PIP (3:1)), including the compliance dates for certain regulated articles; and
  • Whether to consider additional or alternative measures or approaches.

EPA will use the feedback received during the comment period to determine the best path forward, which could include amending the final rules to include additional or alternative exposure reduction measures or extending compliance dates for certain regulated products and articles.


 

By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) announced on March 8, 2021, that “in accordance with Biden-Harris Administration executive orders and directives,” it is asking for additional public input on five final rules for persistent, bioaccumulative, and toxic (PBT) chemicals issued on January 6, 2021, under the Toxic Substances Control Act (TSCA).  EPA states that as a first step in its efforts to review these rules immediately, EPA is opening a 60-day comment period for the public to provide new input on:

  • Whether the rules sufficiently reduce exposure to these chemicals, including exposures to potentially exposed or susceptible subpopulations and the environment;
  • Newly raised compliance issues associated with the final rule on phenol, isopropylated phosphate (3:1) (PIP (3:1)), including the compliance dates for certain regulated articles; and
  • Whether to consider additional or alternative measures or approaches.

EPA states that it will use the feedback received during the comment period to determine the best path forward, which could include amending the final rules to include additional or alternative exposure reduction measures or extending compliance dates for certain regulated products and articles.  Upon publication of the Federal Register notice, EPA will accept public comments for 60 days.
 
Stakeholders recently informed EPA that the prohibition on processing and distribution of PIP (3:1) could impact articles used in a wide variety of electronics, from cell phones, to robotics used to manufacture semiconductors, to equipment used to move COVID-19 vaccines and keep them at the appropriate temperature.  EPA states that stakeholders “note that the complexity of international supply chains makes locating the presence of, and finding alternatives to, PIP (3:1) in components challenging.”  According to EPA, stakeholders assert that an extension to the compliance deadline is necessary to avoid significant disruption to the supply chain for a wide variety of articles.  EPA states that it was not its intent during the development of the final rule to have such a broad disruptive impact.  Thus, EPA “is also announcing its expectation that this specific issue will be addressed as part of the broader re-examination of these rules.”  EPA “intends to extend compliance dates as necessary for the prohibitions on processing and distribution of PIP (3:1) for use in some articles, and some of the articles to which PIP (3:1) has been added.”
 
EPA states that for these same reasons, it is issuing a temporary 180-day “No Action Assurance” indicating that the agency will exercise its enforcement discretion regarding the prohibitions on processing and distribution of PIP (3:1) for use in articles, and the articles to which PIP (3:1) has been added.  EPA “is taking this action to ensure that the supply chain of these important articles is not interrupted while EPA continues to collect the information needed to best inform subsequent regulatory efforts and allow for the issuance of a final agency action to extend the March 8, 2021, compliance date as necessary.”


 

By Lynn L. Bergeson and Carla N. Hutton
 
On March 2, 2021, the U.S. Environmental Protection Agency (EPA) announced that it reached a settlement agreement with Brenntag Pacific, Inc. for violations of the Toxic Substances Control Act (TSCA).  According to EPA, Brenntag Pacific, Inc. has corrected the violations and will pay a $128,265 fine.  EPA states that it discovered the violations following inspections at Brenntag Pacific, Inc. facilities in Fairbanks, Alaska, and in Santa Fe Springs, California.  EPA inspectors “found the company failed to submit accurate and timely reports and notification associated with the import and export of nine chemicals.”  According to EPA, between 2012 and 2015, Brenntag Pacific, Inc. failed to report properly the import production volumes and uses of five chemicals as required by the 2016 Chemical Data Reporting (CDR) Rule.  In addition, the company failed to produce first-time export notices for four chemicals between 2016 and 2017.  EPA notes that under TSCA, chemical importers and manufacturers are required to submit CDR information to EPA every four years.  EPA uses these data to track the chemicals being imported into the United States and to assess the potential human health and environmental effects of these chemicals.  In addition, EPA makes the non-confidential business information it receives available to the public.


 
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