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
 
On October 7, 2021, the Office of Management and Budget’s (OMB) Office of Information and Regulatory Affairs (OIRA) completed its review of a proposed rule on “Regulation of Persistent, Bioaccumulative, and Toxic Chemicals Under TSCA Section 6(h); Phenol, Isopropylated Phosphate (3:1); Further Compliance Date Extension.” The U.S. Environmental Protection Agency (EPA) announced on September 3, 2021, an extension of certain compliance dates for Phenol, Isopropylated Phosphate (3:1) (PIP (3:1)) to March 8, 2022, “to address the hardships inadvertently created by the original applicable compliance dates in the January 2021 final rule to ensure that supply chains are not disrupted for key consumer and commercial goods.” The proposed rule reviewed by OIRA is expected to propose further extensions to certain article-related compliance dates. More information on EPA’s September 3, 2021, announcement is available in our memorandum, “EPA Plans New Rulemaking for PBTs, Extends Compliance Dates for PIP (3:1) Rule.”


 

By Lynn L. Bergeson, Richard E. Engler, Ph.D., and Carla N. Hutton
 
The U.S. Government Accountability Office (GAO) posted a WatchBlog item entitled “Can Chemical Recycling Reduce Plastic Pollution?” on October 5, 2021. The item looks at GAO’s September 2021 Science & Tech Spotlight: Advanced Plastic Recycling. According to GAO, chemical recycling could reduce the amount of plastic that ends up in landfills, potentially reducing the release of chemicals into the environment. Chemical recycling can produce high-quality raw materials, decreasing the demand for fossil fuels and other natural resources. GAO states that the obstacles to using chemical recycling include process and technology challenges, high startup and operating costs, and limited incentives for recycling innovation and investment. GAO notes that new plastics produced from fossil fuels are typically cheaper to produce than recycled plastics, in part due to transportation costs and limited recycling infrastructure, making recycled plastics less marketable. Key questions for policymakers include:

  • What steps could the federal government, states, and other stakeholders take to further incentivize chemical recycling rather than disposal? What are the potential benefits and challenges of these approaches?
     
  • What steps could policymakers take to support a transition toward a circular economy -- one in which products are not disposed of but are recycled for reuse including innovation -- and investment in manufacturing and recycling capacity?
     
  • What might policymakers do to promote advanced recycling technologies while also reducing the hazards associated with existing plastic production and recycling methods?

One issue that GAO fails to consider is the regulatory status of depolymerized plastic. If a polymer cannot be reduced back to the exact starting monomers, the U.S. Environmental Protection Agency (EPA) views the depolymerized plastic as a substance that is different from the starting monomers. Furthermore, making a polymer with depolymerized plastic is, according to the Toxic Substances Control Act (TSCA) nomenclature rules, different than the virgin polymer. These nomenclature complications will likely be a barrier to the commercialization of the closed-loop chemical recycling of plastics.


 

By Lynn L. Bergeson and Carla N. Hutton
 
On August 2, 2021, the U.S. Environmental Protection Agency (EPA) received a petition under Section 21 of the Toxic Substances Control Act (TSCA) seeking a rule requiring cigarette manufacturers to eliminate the hazardous chemicals used and to develop new product designs that eliminate or reduce the cigarette butt disposal risks to the environment. Filed by William David Bush, the petition states that the more than 4,000 chemicals in cigarette smoke come from chemicals within the soil, the paper surrounding the tobacco column, and the manufacturing process, while others are deliberately added. According to the petition, cigarette butts endanger the health of the environment, comprising 30-40 percent of items collected in annual coastal/urban cleanups. Organic compounds “seep from cigarette butts into aquatic ecosystems, becoming acutely toxic to fish and microorganisms.” The petitioner asks EPA to:

  • Determine that the chemical mixtures contained within cigarettes present an unreasonable risk of injury to health and the environment;
  • Order by rule that cigarette manufacturers eliminate the hazardous chemicals used in a mixture with tobacco, including but not limited to the toxic substance inclusions resulting from tobacco growing or handling techniques;
  • Order by rule that cigarette manufacturers develop new product designs that eliminate or reduce the cigarette butt disposal risks to the environment.

EPA acknowledged receipt of Bush’s petition on September 9, 2021, stating that it will grant or deny the petition by October 31, 2021.
 
EPA received a second TSCA Section 21 petition from Bush on August 16, 2021, seeking a determination that the chemical mixtures contained within cosmetics present an unreasonable risk of injury to public health and the environment. According to the petition, since 2009, almost 600 cosmetics manufacturers have reported using 88 chemicals in more than 73,000 products that have been linked to cancer, birth defects, or reproductive harm. The petition states that these toxic chemicals have been banned by the European Union (EU) “and many other nations.” The petition notes that Congress has not given the Food and Drug Administration (FDA) the authority to regulate the chronic risks posed by chemicals and contaminants in cosmetics and that FDA does not have the power to suspend registration or order recalls when products pose a risk of serious adverse health consequences or death. The petition asks that EPA order by rule that cosmetic manufacturers eliminate hazardous chemicals used in mixtures, stating that examples include formaldehyde, paraformaldehyde, methylene glycol, quaternium 15, mercury, dibutyl and diethylhexyl phthalates, isobutyl and isopropyl parabens, long-chain per- and polyfluoroalkyl substances (PFAS), and m- and o-phenylenediamine.

EPA acknowledged receipt of Bush’s second petition on September 20, 2021, stating that it will grant or deny the petition by November 14, 2021.


 

By Lynn L. Bergeson and Carla N. Hutton
 
On September 17, 2021, the U.S. Environmental Protection Agency (EPA) published a final rule amending the regulations applicable to phenol, isopropylated phosphate (3:1) (PIP (3:1)) promulgated under the Toxic Substances Control Act (TSCA). 86 Fed. Reg. 51823. Specifically, EPA is extending the compliance date applicable to the processing and distribution in commerce of certain PIP (3:1)-containing articles, and the PIP (3:1) used to make those articles, from March 8, 2021, to March 8, 2022. For such articles, EPA states that it is also extending the compliance date for the recordkeeping requirements applicable to manufacturers, processors, and distributors from March 8, 2021, to March 8, 2022. According to EPA, the articles covered by the amendment “include a wide range of key consumer and commercial goods such as cellular telephones, laptop computers, and other electronic and electrical devices and industrial and commercial equipment used in various sectors including transportation, life sciences, and semiconductor production.” The final rule is effective September 17, 2021. More information on the final PIP (3:1) rule and on EPA’s plan for a new rulemaking on persistent, bioaccumulative, and toxic (PBT) chemicals is available in our September 3, 2021, memorandum, “EPA Plans New Rulemaking for PBTs, Extends Compliance Dates for PIP (3:1) Rule.”


 

By Lynn L. Bergeson and Carla N. Hutton

The New York State Department of Environmental Conservation (NYS DEC) held a virtual public meeting on September 15, 2021, on its forthcoming regulations to implement the Toxic Chemicals in Children’s Products Law. New York’s Environmental Conservation Law (ECL) Article 37 Title 9 establishes an ingredient disclosure program and prohibits certain chemicals in children’s products. ECL Article 37 instructs NYS DEC to promulgate lists of chemicals of concern and high priority chemicals that must be disclosed if present in children's products by March 1, 2022. ECL Article 37 also prohibits the sale of children’s products containing benzene, asbestos, or tris(1,3-dichloro-2-propyl) phosphate effective January 1, 2023. NYS DEC has posted a list of chemicals under consideration and their practical quantification limits. The list includes the evidence that NYS DEC has identified to justify listing the chemicals. Comments may be submitted via e-mail to .(JavaScript must be enabled to view this email address) or via mail to:

Emily Dominiak
NYS DEC -- Division of Materials Management
625 Broadway
Albany, NY 12233-7252
Comments must be submitted by 5:00 p.m. (EDT) on October 15, 2021.

According to NYS DEC’s website, NYS DEC has made a recording of the September 15, 2021, meeting available for review. The website notes that NYS DEC “will hold a formal public comment period on the proposed rule at a later date, which will be published in the Environmental Notice Bulletin.”


 

By Lynn L. Bergeson and Carla N. Hutton
 
The New York State Department of Environmental Conservation (NYSDEC) will hold a virtual public meeting on September 15, 2021, on the toxic chemicals in children’s products law. NYSDEC will present the chemicals under consideration for listing as Chemicals of Concern and High Priority Chemicals and their practical quantification limits. NYSDEC will also re-present select topics from the May 26, 2021, public meeting, as some details have changed in response to feedback received. NYSDEC states that there will be time for stakeholders to discuss the information presented. Those who wish to attend the virtual public meeting must register. NYSDEC will record the meeting and post the recording afterward.
 
New York’s Environmental Conservation Law (ECL) Article 37 Title 9 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 that must be disclosed if present in children's products by March 1, 2022. ECL Article 37 also prohibits the sale of children’s products containing benzene, asbestos, or tris(1,3-dichloro-2-propyl) phosphate effective January 1, 2023.
 
NYSDEC is in the process of developing a rule to implement portions of the law. According to NYSDEC, the rule is expected 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.


 

By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) announced on August 31, 2021, the availability of the latest Toxic Substances Control Act (TSCA) Inventory. EPA states that the biannual update to the public TSCA Inventory is part of its regular posting of non-confidential TSCA Inventory data. EPA plans the next regular update of the Inventory for winter 2022. According to EPA, the Inventory contains 86,607 chemicals of which 41,953 are active in U.S commerce. Other updates to the TSCA Inventory include new chemical substance additions, commercial activity data and regulatory flags, such as polymer exemptions, TSCA Section 4 test orders, and TSCA Section 5 significant new use rules (SNUR). In April 2021, EPA released a list of 390 chemicals expected to lose their confidential status and move to the public portion of the Inventory. EPA states that it continues to work on final declassifications for these chemicals and plans to include them in the next public posting of the TSCA Inventory.


 

By Lynn L. Bergeson and Carla N. Hutton
 
The White House Office of Science and Technology Policy (OSTP) announced on July 20, 2021, that it is organizing a series of three virtual listening sessions to hear about issues and concerns related to scientific integrity from members of the public who produce, communicate, and use scientific and technical information. 86 Fed. Reg. 38363. According to OSTP, it will use perspectives gathered during the virtual listening sessions to inform the assessment of federal agencies’ scientific-integrity policies and identification of best practices and lessons learned that the National Science and Technology Council’s Task Force on Scientific Integrity is preparing, pursuant to the January 2021 Presidential Memorandum on Restoring Trust in Government Through Scientific Integrity and Evidence-Based Policymaking.

Each of three listening sessions will be organized around a particular theme and audience:

  • Session 1 (Wednesday, July 28, 2021, 2:00 p.m. to 4:00 p.m. (EDT)): Communications, including using effective policies and practices to improve the communication of scientific and technological information, including for engagement of federal scientists and contractors with news media and on social media. The target audience includes individuals from news media, science writers, and science communicators;
     
  • Session 2 (Thursday, July 29, 2021, 11:00 a.m. to 1:00 p.m. (EDT)): Science and Education, including using effective policies and practices to support professional development of scientists and researchers of all genders, races, ethnicities, and backgrounds; to address scientific-integrity issues related to emerging technologies, such as artificial intelligence and machine learning, and evolving scientific practices, such as citizen science and community-engaged research; to improve training of scientific staff about scientific integrity; and to handle disagreements about scientific methods and conclusions. The target audience includes scientists, engineers, and educators from the federal and non-federal sectors; and
     
  • Session 3 (Friday, July 30, 2021, 2:00 p.m. to 4:00 p.m. (EDT)): Use of Scientific and Technical Information, including using the effectiveness of federal scientific integrity policies to promote trust in federal science and address concerns about a lack of scientific integrity impeding the equitable delivery of the federal government’s programs. The target audience includes individuals who use federal scientific and technical information for decision-making or provision of services; individuals from disadvantaged communities; and other consumers of science.

Participants in all sessions may also comment on the predominant challenges they perceive to scientific integrity in federal agencies and effective practices for minimizing political or other inappropriate interference in the conduct, communication, or use of federal science. Speakers will have up to two minutes each to make a comment. As many speakers will be accommodated as the scheduled time allows. Individuals unable to attend the listening sessions or who would like to provide more detailed information may respond to the Request for Information (RFI) to Improve Federal Scientific Integrity Policies. Comments on the RFI are due July 28, 2021. The registration deadline for the virtual listening sessions is July 23, 2021, at 5:00 p.m. (EDT).


 

By Lynn L. Bergeson and Carla N. Hutton

The Center for Environmental Health (CEH) announced on June 29, 2021, that it filed suit against three companies in the U.S. District Court for the District of Columbia for alleged violations of the Chemical Data Reporting (CDR) rule. According to CEH, an investigation found that four companies imported 65 chemicals that are subject to reporting under the CDR rule. CEH states that the chemicals “include several recognized carcinogens, including benzene, butadiene, trichloroethylene, isoprene, di(2-ethylhexyl)phthalate, di-isononyl phthalate, carbon black and arsenic.” In February 2021, CEH notified the importers of the apparent violations in accordance with Section 20(b) of the Toxic Substances Control Act (TSCA). One of the four companies, Tribute Energy, “approached CEH and entered into an agreement to audit its operations and come into compliance. CEH is not taking legal action against Tribute in recognition of its good faith and commitment to following the law.” CEH filed suit against the other three companies under TSCA Section 20(a). The three companies are 3N International, Harwick Standard Distribution Corp., and Braskem Inc. CEH notes that the U.S. Environmental Protection Agency (EPA) has designated some of the chemicals as high-priority substances under TSCA and is conducting risk evaluations to determine whether they present an unreasonable risk to human health or the environment. CEH states that “CDR reporting is critical in determining these risks because, according to EPA, the ‘exposure information [reported] is an essential part of developing risk evaluations and . . . collecting this exposure information is critical to [EPA’s] mission of characterizing exposure [and] identifying potential risks.’” CEH asks that the court order the companies to report their imports in compliance with the CDR rule and restrain the companies from any other ongoing violations of CDR reporting requirements.


 

By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) published a final rule on June 29, 2021, that requires manufacturers (including importers) of 50 specified chemical substances to report certain lists and copies of unpublished health and safety studies to EPA. 86 Fed. Reg. 34147. EPA is issuing the final rule pursuant to Section 8(d) of the Toxic Substances Control Act (TSCA) and the TSCA Health and Safety Data Reporting rule codified at 40 C.F.R. Part 716. The chemical substances subject to the rule consist of the 20 designated by EPA as high-priority substances and the 30 organohalogen flame retardants being evaluated for risks by the Consumer Product Safety Commission (CPSC) under the Federal Hazardous Substances Act (FHSA). EPA states that it is taking this action because the TSCA Interagency Testing Committee (ITC) added these chemical substances to the TSCA Section 4(e) Priority Testing List through its 69th and 74th Reports. EPA will use the submitted information to inform the risk evaluations currently underway for 20 high-priority substances and for future prioritization.
 
The table below lists the high-priority substances and organohalogen flame retardants included in the final rule.
 

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
1,1-Dichloroethane 75-34-3
1,2-Dichloroethane 107-06-2
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(2-methylpropyl) ester) 84-69-5
Ethylene dibromide 106-93-4
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
4,4'-(1-Methylethylidene)bis[2,6-dibromophenol] (TBBPA) 79-94-7
Phosphoric acid, triphenyl ester (TPP) 115-86-6
Phthalic anhydride 85-44-9
1,1,2-Trichloroethane 79-00-5
Tris(2-chloroethyl) phosphate (TCEP) 115-96-8
Organohalogen Flame Retardants
Bis(2-ethylhexyl) tetrabromophthalate 26040-51-7
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-Ethylhexyl-2,3,4,5-tetrabromobenzoate 183658-27-7
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
Phosphoric acid, 2,2-bis(chloromethyl)-1,3-propanediyl tetrakis(2-chloroethyl) ester 38051-10-4
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(1-chloro-2-propyl)phosphate 13674-84-5
Tris(2-chloro-1-propyl)phosphate 6145-73-9
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(1,3-dichloro-2-propyl)phosphate 13674-87-8
Tris(tribromoneopentyl)phosphate 19186-97-1
2,4,6-Tris-(2,4,6-tribromophenoxy)-1,3,5-triazine 25713-60-4

 
The final rule will be effective July 29, 2021. Requests to withdraw a chemical substance from the final rule pursuant to 40 C.F.R. Section 716.105(c) must be received by July 13, 2021. Information specified in the final rule is due to EPA by September 27, 2021. Detailed information about the final rule is available in our June 29, 2021, memorandum, “Manufacturers and Importers of 20 High-Priority Chemicals and 30 Organohalogen Flame Retardants Must Submit Data to EPA.”


 
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