EPA Seeks Public Comment on First Batch of Draft Scope Documents

The U.S. Environmental Protection Agency (EPA) announced on April 6, 2020, that the first set of draft scope documents for the next group of chemicals undergoing risk evaluation under the Toxic Substances Control Act (TSCA) is available for comment. EPA released draft scope documents for 13 of the next 20 chemicals undergoing risk evaluation, and stated that it will soon release and accept public comments on the seven remaining draft scope documents. According to EPA, the scope documents include the proposed conditions of use, hazards, exposures, and the potentially exposed or susceptible subpopulations that EPA expects to consider in the risk evaluations. The documents also include: a description of the reasonably available information and the science approaches that EPA plans to use, a conceptual model that outlines the potential hazards and exposures throughout the life cycle of the chemical, an analysis plan to identify the approaches and methods EPA plans to use to assess health and environmental factors, and a potential plan for peer review.

As reported in our December 20, 2019, memorandum, EPA designated these chemicals as a high priority for risk evaluation in December 2019. According to EPA, seeking public input on the conditions of use to be included in the risk evaluations for these chemicals is the next step in the process outlined in TSCA. EPA states that “[i‌]t is important to note that being designated as a high-priority chemical does not mean that a chemical is high risk.” EPA will publish a Federal Register notice announcing the availability of the draft scope documents for public comment. Publication of the notice will begin a 45-day comment period.

p-Dichlorobenzene

EPA states on its web page on p-dichlorobenzene that the primary uses for p-dichlorobenzene are as a processing agent in various types of manufacturing and as an odor agent and deodorizer. Information from the 2016 Chemical Data Reporting (CDR) for p-dichlorobenzene indicates the reported production volume is between 50 million and 100 million pounds per year (lbs/year).

According to the web page, EPA preliminarily identified conditions of use associated with the manufacturing (including import), processing, distribution, use, and disposal of p-dichlorobenzene. Uses include the following:

• In plastic material and resin manufacturing;
   
• During the process of manufacturing pesticides, fertilizers and other agricultural chemicals, and as odor agents in wholesale and retail trade;
   
• As a deodorizer or air freshener (including toilet and garbage deodorizers);
   
• In automotive care products and lubricants and greases (e.g., automotive fuel additives); and
   
• In plastic foam sealant or insulation.
   

1,2-Dichloroethane

According to EPA’s web page on 1,2-dichloroethane, the primary use of 1,2-dichloroethane is in plastic material manufacturing. Information from the 2016 CDR for 1,2-dichloroethane indicates the reported volume was between 20 and 30 billion lbs/year (manufacture and import).

EPA states that it preliminarily identified conditions of use associated with the manufacturing (including import), processing, distribution, use, and disposal of 1,2-dichloroethane. Uses include:

• In petrochemical, plastic material, and resin, and other basic organic chemical manufacturing;
   
• In the manufacturing of petroleum and coal products, pharmaceuticals and medicine, and petroleum production;
   
• In adhesives and heat transferring agents;
   
• In lubricants and greases;
   
• In solvents (for cleaning and degreasing);
   
• As an industrial oxidizing inhibitor;
   
• As a lead scavenger in fuels; and
   
• In plastic and rubber products.
   

trans-1,2- Dichloroethylene

EPA’s web page on trans-1,2- dichloroethylene states that the primary uses for trans-1,2-dichloroethylene are as a solvent in processing agents and incorporated into formulations for actions such as for cleaning and degreasing. Information from the 2016 CDR for trans-1,2-dichloroethylene indicates the reported production volume is between one million and 10 million lbs/year (manufacture and import).

According to EPA, it preliminarily identified conditions of use associated with the manufacturing (including import), processing, distribution, use, and disposal of trans-1,2-dichloroethylene. Uses include the following:

• As an intermediate in chemical product manufacture;
   
• As a solvent for cleaning and degreasing;
   
• As a propellant and blowing agent;
   
• As a plating and surface treating agent;
   
• In adhesives and sealants;
   
• In spot cleaners and stain removers;
   
• In lubricants and greases;
   
• In refrigerants;
   
• In spray lubricants and greases; and
   
• In aerosol degreasers.
   

o-Dichlorobenzene

According to EPA’s web page on o-dichlorobenzene, the primary uses for o-dichlorobenzene are in the manufacturing of dyes, paints, and pigments and in products used for cleaning, degreasing, and painting. Information from the 2016 CDR for o-dichlorobenzene indicates the reported production volume is between 100,000 and 500,000 lbs/year (manufacture and import).

EPA states that it preliminarily identified conditions of use associated with the manufacturing (including import), processing, distribution, use, and disposal of o-dichlorobenzene. Uses include:

• In chemical product and preparation manufacturing;
   
• In the manufacturing of plastic, printing ink, paints and coatings, and synthetic dyes and pigments;
   
• In ink, toner, and colorant products;
   
• In paints and coatings (including paint thinners and paint removers); and
   
• In lubricants and greases (including degreasers).
   

1,1,2-Trichloroethane

EPA states on its web page for 1,1,2-trichloroethane that the primary use of 1,1,2-trichloroethane is in plastic and petrochemical manufacturing. Information from the 2016 CDR for 1,1,2-trichloroethane indicates the reported production volume is between 100 and 250 million lbs/year (manufacture and import).

According to EPA, it preliminarily identified conditions of use associated with the manufacturing (including import), processing, distribution, use, and disposal of 1,1,2-trichloroethane. Uses include:

• In plastic, petrochemical, and other chemical product and preparation manufacturing;
   
• In industrial adhesives and sealants; and
   
• As a laboratory chemical.
   

1,2-Dichloropropane

According to EPA’s web page on 1,2-dichloropropane, the primary use of 1,2-dichloropropane is in organic chemical manufacturing. Information from the 2016 CDR for 1,2-dichloropropane indicates the reported production volume for manufacturing (including import) has remained stable from 1986-2002 and withheld from 2006-2015. EPA states that it is withholding production volume of 1,2-dichloropropane to protect claims of confidential business information (CBI).

EPA states that it preliminarily identified conditions of use associated with the manufacturing (including import), processing, distribution, use, and disposal of 1,2-dichloropropane. Uses include:

• As an intermediate in basic organic chemical manufacturing and other chemical product and preparation manufacturing;
   
• As an industrial processing aid for paper sizing agents;
   
• As a laboratory chemical; and
   
• In cleaning and furniture care products.
   

1,1-Dichloroethane

EPA states on its web page for 1,1-dichloroethane that the primary use of 1,1-dichloroethane is in organic chemical manufacturing. Information from the 2016 CDR for 1,1-dichloroethane indicates the reported production volume manufactured decreased overall from 1986-2011, and was withheld from 2012-2015. EPA states that it is withholding production volume of 1,1-dichloroethane to protect CBI claims.

According to EPA, it preliminarily identified conditions of use associated with the manufacturing, processing, distribution, use, and disposal of 1,1-dichloroethane. Uses include the following:

• In organic chemical and other chemical product and preparation manufacturing; and
   
• As a laboratory chemical.
   

4,4′-(1-Methylethylidene)bis[2, 6-dibromophenol] (TBBPA)

According to EPA’s web page for TBBPA, the primary uses for TBBPA are as a reactant for flame retardants in plastic material and resin manufacturing and as a flame retardant incorporated into electrical equipment. Information from the 2016 CDR for TBBPA indicates the reported production volume is more than 50 million lbs/year.

EPA states that it preliminarily identified conditions of use associated with the manufacturing (including import), processing, distribution, use, and disposal of TBBPA. Uses include:

• As a flame retardant in plastic material and resin, electrical equipment, appliance and component, computer, and transportation equipment manufacturing;
   
• In adhesive manufacturing; and
   
• As a flame retardant in electrical and electronic products, batteries, and fabric, textile and leather products, laboratory chemicals, and building/construction materials for commercial and consumer uses.
   

Tris(2-Chloroethyl) Phosphate (TCEP)

EPA states on its web page for TCEP that the primary use for TCEP is as a flame retardant in paint and coating manufacturing. Information from the 2016 CDR for TCEP indicates the reported production volume is between 25,000 and 100,000 lbs/year (manufacture and import).

According to EPA, it preliminarily identified conditions of use associated with the manufacturing (including import), processing, distribution, use, and disposal of TCEP. Uses include the following:

• In paint and coating manufacturing, polyester resin, thermoplastics, and articles;
   
• In industrial and commercial aircraft interiors and aerospace products;
   
• For laboratory chemicals; and
   
• In commercial and consumer products, including paints and coatings, fabric, textile, and leather products.
   

Phosphoric Acid, Triphenyl Ester (TPP)

According to EPA’s web page on TPP, the primary uses for TPP are as a flame retardant or solvent in chemical and plastics manufacturing. Information from the 2016 CDR for TPP indicates the reported production volume is between 1 million and 10 million lbs/year (manufacture and import).

EPA states that it preliminarily identified conditions of use associated with the manufacturing (including import), processing, distribution, use, and disposal of TPP. Uses include the following:

• The flame retardant is processed as a reactant, incorporated into a formulation, mixture, or reaction products, and incorporated into articles;
   
• TPP is reportedly used in commercial paints and coatings and for plastic and rubber products; and
   
• Several consumer uses were reported, including foam seating and bedding products.
   

Ethylene Dibromide

EPA states on its web page for ethylene dibromide that the primary uses for ethylene dibromide are as an additive in processing petroleum and coal products manufacturing and in fuel and related products. Information from the 2016 CDR for ethylene dibromide indicates the reported production volume is between 1 million and 10 million lbs/year (manufacture and import).

According to EPA, it preliminarily identified conditions of use associated with the manufacturing (including import), processing, distribution, use, and disposal of ethylene dibromide. Uses include the following:

• Fuels and related products, as an additive in aviation and racing fuels for commercial and consumer use; and
   
• Laboratory chemical for commercial use.
   

1,3-Butadiene

According to EPA’s web page on 1,3-butadiene, the primary use of 1,3-butadiene is in the manufacturing of plastic and rubber products. Information from the 2016 CDR for 1,3-butadiene indicates the reported production volume is between one and five billion lbs/year (manufacture and import).

EPA states that it preliminarily identified conditions of use associated with the manufacturing (including import), processing, distribution, use, and disposal of 1,3-butadiene. Uses include the following:

• In the manufacturing of adhesive, synthetic rubber, organic fiber, plastic material and resin, paints and coatings, and other chemical product and preparation manufacturing;
   
• In the manufacturing of petroleum, petrochemical, and solid rocket fuels;
   
• In adhesives and sealants;
   
• In fuels and related products;
   
• In automotive care products;
   
• In lubricants and lubricant additives;
   
• In paints and coatings; and
   
• In plastics and rubber products (including rubber tires).
   

1,3,4,6,7,8-Hexahydro-4,6,6,7,8,8-Hexamethylcyclopenta [g]-2-Benzopyran (HHCB)

EPA states on its web page for HHCB that the primary use of HHCB is as an odor agent for fragrances, for instance, air care products and cleaning products. Total production volume of HHCB in 2015 was between one million and ten million pounds.

According to EPA, it preliminarily identified conditions of use associated with the manufacturing (including import), processing, distribution, use, and disposal of HHCB. Uses include the following:

• In air care products (e.g., aroma chemicals, air fresheners in motor vehicles, scented candles, aerosols and spays);
   
• In cleaning and furnishing care products (e.g. all-purpose cleaners and bathroom cleaners);
   
• In laundry and dishwashing products (e.g., laundry detergent and fabric softener);
   
• In plastic and rubber products; and
   
• In paper products.
   

Commentary

EPA is to be commended for releasing approximately 1,000 pages of documents and doing so in just a few months after designating each as high priority — months that include both the December holidays and the disruptions due to coronavirus. EPA has yet to release draft scoping documents for the seven phthalate esters, phthalic anhydride, and formaldehyde; all are likely more complex due to the very wide array of conditions of use. EPA still has over two months to issue those scoping documents, although those months will undoubtedly be busy for EPA as it completes the risk evaluations of the first ten chemicals.

As is the case on all TSCA Section 6 actions taken by EPA, the scoping documents released yesterday are substantial documents that will require thorough review by stakeholders. This is especially true if any of the 13 substances is in a company’s supply chain. It is vital that EPA have an accurate picture of the conditions of use for each so that it can make an accurate assessment.

We note that EPA indicates that in complying with TSCA, as stated in the draft scoping document on o-diclorobenzene, for example, it plans to use EPA resources efficiently, avoid duplicating efforts taken pursuant to other EPA programs, maximize scientific and analytical efforts, and meet the statutory deadline for completing risk evaluations. We note further that EPA is continuing to consider whether and how other EPA-administered statutes and associated regulatory programs address the presence of the chemicals undergoing risk evaluation scoping in exposure pathways falling under the jurisdiction of these EPA statutes. We look forward to seeing how EPA addresses regulation under TSCA Section 6 in light of regulation under other EPA authorities. In addition, EPA seems to be considering exposures related to disposal of products that contain the substances (so-called legacy uses) in addition to releases and exposures of on-going uses. It remains to be seen whether these scoping documents satisfy the Ninth Circuit court ruling in Safer Chemicals, Healthy Families v. EPA.

As a point of interest, we note that upon EPA’s defining the scope of the risk evaluations, under TSCA Section 18(b), as amended by the Frank R. Lautenberg Chemical Safety for the 21st Century Act, state actions could be preempted under the “pause preemption” provision. Whether this provision comes into play in the current set of scope documents remains to be seen.