REGULATORY MEMORANDUM

EPA Releases Second Set of Draft Scope Documents for Remaining High-Priority Substances

On April 17, 2020, the U.S. Environmental Protection Agency (EPA) released the draft scope documents for the remaining seven of the 20 chemicals designated as high-priority substances for risk evaluation under the Toxic Substances Control Act (TSCA). The draft scope documents include the proposed conditions of use, hazards, exposures, and the potentially exposed or susceptible subpopulations 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 that EPA plans to use to assess health and environmental factors; and a potential plan for peer review.

EPA notes that one of the draft scope documents is for formaldehyde, “a chemical that has been studied by the agency for many years.” EPA states that it used work done under its Integrated Risk Information System (IRIS) program to select formaldehyde as a high priority for risk evaluation, “and today’s action represents the next step in the process required by TSCA.” According to EPA, moving forward, it will use the work done for IRIS to inform the formaldehyde risk evaluation.

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. Information on the first batch of draft scope documents is available in our April 7, 2020, memorandum.

Butyl Benzyl Phthalate (BBP) (1,2-Benzenedicarboxylic Acid, 1-Butyl 2-(Phenylmethyl) Ester)

EPA states on its web page on BBP that the primary use for BBP is as a plasticizer in adhesives and sealants, floor coverings, paints and coatings, and use in plastic and rubber products. Information from the 2016 Chemical Data Reporting (CDR) for BBP indicates the reported production volume is between 10 million and 50 million pounds per year (lbs/year) (manufacture and import).

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

  • In floor coverings;
     
  • In adhesive and sealant manufacturing and paint and coating manufacturing;
     
  • For laboratory chemicals; and
     
  • In commercial and consumer products, including adhesives and sealants, paints and coatings, floor coverings, furniture, fabric, textiles, and leather.
     

Dibutyl Phthalate (DBP) (1,2-Benzenedicarboxylic Acid, 1,2-Dibutyl Ester)

According to EPA’s web page on DBP, the primary use for DBP is as a plasticizer, in adhesives and sealants, and paints and coatings. Information from the 2016 CDR for DBP 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, processing, distribution, use, and disposal of DBP. Uses include the following:

  • In adhesives and sealants;
     
  • In paints and coatings;
     
  • For laboratory chemicals; and
     
  • In commercial and consumer products, including adhesives and sealants, paints and coatings, floor coverings, furniture, fabric, textiles, and leather.
     

Dicyclohexyl Phthalate (1,2-Benzenedicarboxylic Acid, 1,2-Dicyclohexyl Ester)

EPA states on its web page on dicyclohexyl phthalate that the primary use for dicyclohexyl phthalate is as a plasticizer in adhesives and plastic and rubber products and resins. Information from the 2016 CDR for dicyclohexyl phthalate indicates that the reported production volume is between 500,000 and 1 million lbs/year.

According to the web page, in the draft scope, EPA preliminarily identified conditions of use associated with the manufacturing, processing, distribution, use, and disposal of dicyclohexyl phthalate. Uses include the following:

  • As a plasticizer in adhesives, paints and coatings, plastic products, rubber products, and plastic resin manufacturing;
     
  • As a phlegmatizer (to improve safety and stability) in a variety of peroxide curing agent mixtures used in industrial and commercial applications, such as roofing systems, road markings, coatings, adhesives, and other composites;
     
  • In industrial and commercial automobile and aerospace products;
     
  • For laboratory chemicals; and
     
  • In commercial and consumer products, such as adhesives and sealants, and plastic and rubber products.
     

Diethylhexyl Phthalate (DEHP) (1,2-Benzenedicarboxylic Acid, 1,2-Bis(2-Ethylhexyl) Ester)

According to EPA’s web page on DEHP, DEHP is most commonly used as a plasticizer. As reported to EPA during the 2016 CDR period and described here as a range to protect production volumes that were claimed as confidential business information (CBI), aggregate production volume of DEHP in 2015 was between 100 million and 250 million lbs.

EPA states that it preliminarily identified conditions of use associated with the manufacturing, processing, distribution, use, and disposal of DEHP. Uses include the following:

  • In paint and coating manufacturing, and industrial polish;
     
  • Plasticizer in food, beverage, and tobacco product manufacturing; medical devices; and plastic material and resin manufacturing;
     
  • In industrial and commercial aircraft interiors and aerospace products and adhesives; and
     
  • In commercial and consumer products, including paints and coatings, fabric, lawn care, and textile and leather products.
     

Di-Isobutyl Phthalate (DIBP) (1,2-Benzenedicarboxylic Acid, 1,2-Bis(2-Methylpropyl) Ester)

EPA states on its web page on DIBP that the primary use for DIBP is a plasticizer in adhesive and sealant manufacturing. Information from the 2012 CDR indicates that the reported production volume was up to 500,000 lbs/year (manufacture and import). The production volume reported to EPA during the 2016 CDR reporting period is CBI.

According to the web page, EPA preliminarily identified conditions of use associated with the manufacturing, processing, distribution, use, and disposal of DIBP. Uses include the following:

  • In adhesives and sealants;
     
  • In paints and coatings;
     
  • In plastic and rubber products;
     
  • For laboratory chemicals; and
     
  • In commercial and consumer products, including adhesives and sealants, paints and coatings, plastic and rubber, fabric, textiles and leather, and inks, toner, and colorant.
     

Formaldehyde

According to EPA’s web page on formaldehyde, information from the 2016 CDR for formaldehyde indicates that the reported production volume is between 1 billion and 5 billion lbs/year (manufacture and import).

EPA states that it preliminarily identified conditions of use associated with the manufacturing, processing, distribution, use, and disposal of formaldehyde. There are many uses, including (but not limited to) the following:

  • Adhesives and sealants;
     
  • Pesticides and agricultural chemicals;
     
  • Lawn and garden products;
     
  • Personal care products;
     
  • Plastic materials;
     
  • Resins, glues, and binders;
     
  • Paper manufacturing;
     
  • Various petrochemical processes and products;
     
  • Wood product manufacturing; and
     
  • Textiles, apparel, and leather.
     

Phthalic Anhydride (1,3-Isobenzofurandione)

EPA states on its web page on phthalic anhydride that the primary use for phthalic anhydride is as a reactant used for processing. Information from the 2016 CDR indicates that the reported production volume is between 500 million and 750 million lbs (manufacture and import).

According to the web page, EPA preliminarily identified conditions of use associated with the manufacturing, processing, distribution, use, and disposal of phthalic anhydride. Uses include the following:

  • In adhesives, paints and coatings, plastic products, and resin manufacturing;
     
  • In industrial and commercial automobile interiors and aerospace products;
     
  • In commercial use of ink and toner products, water filtration applications, oil treatment of wood, and wire coating and insulation;
     
  • For laboratory chemicals; and
     
  • In consumer products, including paints and coatings and adhesives.
     

Commentary

In releasing the second set of draft scope documents, EPA has now completed draft scope documents for the first 20 substances designated as high priority for risk evaluation under TSCA. EPA is to be congratulated for achieving this goal under the stressful circumstances that exist. Under EPA’s TSCA risk evaluation rule at 40 C.F.R. Part 702, EPA must publish final scope documents no later than six months after initiation of the risk evaluation, or by June 20, 2020. In that EPA will be providing a 45-day comment period starting from the date the Federal Register notice announces the availability of the draft scope documents, timing will be tight to issue in final the scope documents by the June 20, 2020, deadline.

As with the draft scope documents for the first 13 substances, EPA appears to be addressing past uses that are no longer ongoing, so-called legacy uses, as conditions of use. In its development of the scope documents, EPA is also continuing to consider whether and how other EPA-administered statutes, and any associated regulatory programs, may already address the presence of the substances in exposure pathways falling under the jurisdiction of these other EPA-administered statutes.

Preparing these scope documents is a complex undertaking, especially considering the broad array of conditions of use EPA must address in them in anticipation of conducting the actual risk evaluation required under TSCA Section 6. For example, the scope of the diethylhexyl phthalate includes releases and exposures from articles, from contamination in air, water, soil, or sediment, as well as direct handling by workers and consumers.

Conversely, in the draft scope document for formaldehyde, EPA states that it will not cover within the scope of the risk evaluation certain composite wood products that are subject to Congressionally mandated emission standards as reflected in Formaldehyde Emissions Standards for Composite Wood Products Rule (40 C.F.R. Part 770). It is not clear if the 0.05 - 0.13 parts per million (ppm) formaldehyde content that is permissible in composite wood products covered by the composite wood rule might contribute meaningfully to the total exposure to formaldehyde from all uses. EPA will have to justify its exclusion of this potential source of formaldehyde from its risk evaluation. EPA’s preliminary decision not to impose further restrictions on manufactured wood during the risk management phase would be supported if during the risk management phase EPA were to find unreasonable risk across a variety of exposure pathways. If, however, such is not the case, EPA’s judgment will be questioned.

 
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