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.

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 Heather J. Blankinship, Senior Manager with B&C® Consortia Management (BCCM), a Bergeson & Campbell (B&C®) affiliate, and Richard E. Engler, Ph.D., B&C’s Director of Chemistry, to discuss chemical testing under the Toxic Substances Control Act (TSCA). Since Congress amended TSCA in 2016, the U.S. Environmental Protection Agency (EPA) has been slowly ratcheting up required chemical testing under TSCA Section 4. Congress gave EPA expanded testing authority under the 2016 Amendments, and EPA is exercising its new authority to compel chemical data production. These test orders authorize EPA to demand the production of new test data by the manufacturers and sometimes processors of the chemical substances at issue. Transactionally, this means that competitors in the marketplace band together to generate the data EPA seeks. We discuss the reality of quickly forming these consortia and the business and scientific challenges consortia managers face in complying with these federally enforceable test orders. It is not as easy as you may think!

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 May 7, 2021, that it is partnering with the People for the Ethical Treatment of Animals (PETA) Science Consortium International, Unilever, and Syngenta on a three-part virtual workshop series on “Using In Silico and In Vitro Approaches for Next Generation Risk Assessment of Potential Respiratory Toxicants.”  EPA states that this webinar series supports its commitment “to collaborate with partners and stakeholders to reduce, refine, or replace vertebrate animal testing, as outlined in the Strategic Plan to Promote the Development and Implementation of Alternative Test Methods within the [Toxic Substances Control Act (TSCA)] Program.”  The webinars will take place on May 19, May 26, and June 2, 2021, from 8:00 a.m. to 10:00 a.m. (EDT).  Each webinar will feature three speakers.  The meeting agenda and registration information are available at www.thepsci.eu/inhalation-webinars.  Attendees must register for each of the three webinars individually.


 

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 February 3, 2021, the latest update to the Toxic Substances Control Act (TSCA) Inventory, “a list of all existing chemical substances manufactured, processed, or imported” in the United States.  EPA states that this biannual update to the public TSCA Inventory is part of its regular posting of non-confidential TSCA Inventory data.  EPA plans to release the next regular update of the Inventory in summer 2021.  According to EPA, the Inventory contains 86,557 chemicals of which 41,864 are active in U.S commerce.  EPA notes that 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).


 

By Lynn L. Bergeson and Carla N. Hutton

The U.S. Environmental Protection Agency (EPA) announced on January 15, 2021, that it has issued test orders under Section 4 of the Toxic Substances Control Act (TSCA) to obtain additional data on nine of the next 20 chemicals undergoing risk evaluation.  EPA states that after reviewing the available data on these chemicals, it determined additional data are needed and is using its TSCA test order authority to require companies to develop and submit information on environmental hazard and inhalation and dermal exposures for workers.  According to EPA, companies subject to the test orders may provide EPA with existing data or conduct new tests.  Companies may also form consortia to consolidate costs and burden and to avoid unnecessary duplication of testing.  The nine chemicals subject to the Section 4 test orders are:

  • Chlorinated Solvents:
    • 1,1,2-Trichloroethane;
    • 1,1-Dichloroethane;
    • 1,2-Dichloroethane;
    • 1,2-Dichloropropane;
    • Trans-1,2-Dichloroethylene;
    • o-Dichlorobenzene; and
    • p-Dichlorobenzene;
  • Flame Retardants:
    • 4,4ʹ-(1-Methylethylidene)bis[2,6-dibromophenol] (TBBPA); and
    • Phosphoric acid, triphenyl ester (TPP).

EPA states that the orders and any data submitted in response to the orders will be made publicly available on EPA’s website and in applicable dockets on www.regulations.gov.  More information will be available in a forthcoming memorandum that will be posted on our website.


 

By Lynn L. Bergeson and Carla N. Hutton
 

On October 14, 2020, a coalition of North Carolina non-governmental organizations (NGO) petitioned the U.S. Environmental Protection Agency (EPA) for a Toxic Substances Control Act (TSCA) Section 4 test rule for 54 per- and polyfluoroalkyl substances (PFAS) manufactured by The Chemours Company (Chemours) at its chemical production facility in Fayetteville, North Carolina.  The petition, filed under TSCA Section 21, seeks issuance of a rule or order under TSCA Section 4 compelling Chemours to fund and carry out testing under the direction of a panel of independent scientists.  EPA states in its letter acknowledging receipt of the petition that under TSCA Section 21, it has 90 days after the date the petition is filed to grant or deny the petition (January 11, 2021, in this case).  If the Administrator grants the petition, the Administrator shall promptly commence an appropriate proceeding.  If the Administrator denies the petition, the Administrator shall publish the reasons for such a denial in the Federal Register.  The petition was filed by Center for Environmental Health, Cape Fear River Watch, Clean Cape Fear, Democracy Green, the NC Black Alliance, and Toxic Free NC.  More information will be available in a forthcoming memorandum that will be posted on our website.


 

By Lynn L. Bergeson and Carla N. Hutton
 
On September 30, 2020, the U.S. Environmental Protection Agency (EPA) will hold a webinar on “Identification of NAMs for Placement on the TSCA Section 4(h)(2)(C) List:  A Proposed NAM Nomination Form.”  The Frank R. Lautenberg Chemical Safety for the 21st Century Act (Lautenberg Act) amended Section 4(h)(2)(c) of the Toxic Substances Control Act (TSCA) to require EPA to develop a list of alternative test methods or strategies that are “scientifically reliable, relevant, and capable of providing information of equivalent or better scientific reliability and quality to that which would be obtained from vertebrate animal testing.”  The current TSCA Section 4(h)(2)(C) List is available on the EPA website.  EPA’s 2018 Strategic Plan to Promote the Development and Implementation of Alternative Test Methods Within the TSCA Program provides initial criteria for considering scientific reliability and relevance of new approach methodologies (NAM) to be eligible for placement on the List.  EPA states that it “envisions that any party interested in proposing a NAM for placement on the List would use a nomination form.”  The webinar will walk through the proposed nomination form.
 
The webinar is co-organized by the People for the Ethical Treatment of Animals (PETA) International Science Consortium, EPA, and the Physicians for Responsible Medicine (PCRM).  EPA notes that it does not necessarily endorse the views of the speakers.


 
By Lynn L. Bergeson and Carla N. Hutton
 
On August 3, 2020, the U.S. Environmental Protection Agency (EPA) announced $3,980,782 in funding to five academic research teams to develop New Approach Methods (NAM) for evaluating chemical toxicokinetics.  According to EPA, compared to traditional animal testing, NAMs allow researchers better to predict potential hazards for risk assessment purposes without the use of traditional methods that rely on animal testing.  EPA is providing a grant of up to $800,000 to each research team through its Science to Achieve Results (STAR) Program.  EPA states that the projects will address gaps in ways to obtain data for informing chemical toxicokinetics and exposure-related factors not currently considered.  The five recipients include:
  • Purdue University to create an integrated blood brain barrier computer model to help determine if a chemical may cause neurotoxicity;
     
  • Texas A&M University to help integrate different types of chemical safety testing for more robust results;
     
  • University of Nevada to develop better estimations of the bioavailability of chemicals to assess the significance of public exposure;
     
  • Vanderbilt University to work on methods to refine organ-on-chip devices for chemical testing; and
     
  • Woods Hole Oceanographic Institution to determine how zebrafish metabolism can be better correlated to the human metabolism to improve models for chemical toxicity testing.

 

By Lynn L. Bergeson and Carla N. Hutton
 
On June 24, 2020, the U.S. Environmental Protection Agency (EPA) released a New Approach Methods (NAM) Work Plan that will “serve[] as a roadmap for meeting its animal testing reduction goals set forth in Administrator Andrew Wheeler’s 2019 Directive.”  According to EPA’s June 24, 2020, press release, the Work Plan describes how EPA plans to develop, test, and apply chemical safety testing approaches that reduce or replace the use of animals.  EPA states that compared to traditional animal testing, NAMs allow researchers better to predict potential hazards for risk assessment purposes without the use of traditional methods that rely on animal testing.  The objectives of the Work Plan include:

  • Evaluating regulatory flexibility for the use of NAMs;
     
  • Establishing baselines and metrics for assessing progress;
     
  • Developing NAMs that fill critical information gaps;
     
  • Establishing scientific confidence in NAMs;
     
  • Demonstrating NAMs application to regulatory decisions; and
     
  • Engaging with stakeholders to incorporates their knowledge and address their concerns regarding EPA’s phaseout of mammalian testing.

EPA states that the Work Plan will evolve as EPA’s knowledge and experience grow and as outside experts offer their perspectives and contributions.  EPA will regularly review the Work Plan to ensure that the efforts involved provide the best path to success.  More information on the 2019 directive to prioritize efforts to reduce animal testing is available in our September 11, 2019, blog item, “EPA Administrator Signs Directive Intended to Reduce Animal Testing, Awards $4.25 Million for Research on Alternative Methods to Animal Testing.”
 


 

By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) announced on January 15, 2020, that it is partnering with People for the Ethical Treatment of Animals (PETA) and Physicians for Responsible Medicine (PCRM) to host public webinars on various topics related to reducing, refining, or replacing vertebrate animal testing.  A webinar will be held on January 22, 2020, covering the use and application of the Collaborative Acute Toxicity Modeling Suite (CATMoS), a free resource for screening organic chemicals for acute oral toxicity.  Drs. Nicole Kleinstreuer and Kamel Mansouri will discuss the development of and demonstrate CATMoS, which was developed during a project in which the National Toxicology Program (NTP) Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM) and the EPA National Center for Computational Toxicology (NCCT) collected a large body of rat oral acute toxicity data and made these data available to project participants.  Participants built several models that were then used to generate consensus predictions for the acute oral toxicity endpoints of interest to regulatory agencies.  The webinar will offer a walk-through of how to use the modeling suite to generate acute oral toxicity predictions for chemicals of interest.  EPA notes that it “does not necessarily endorse the views of the speakers.”


 
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