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By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) announced on September 8, 2021, the availability of the draft scope of the risk evaluation to be conducted for octamethylcyclotetra-siloxane (D4). 86 Fed. Reg. 50347. As reported in our October 7, 2020, blog item, through the American Chemistry Council’s Silicones Environmental, Health, and Safety Center, Dow Silicones Corporation, Elkem Silicones USA Corporation, Evonik Corporation, Momentive Performance Materials, Shin-Etsu Silicones of America, Inc., and Wacker Chemical Corporation requested a risk evaluation of D4 pursuant to Section 6 of the Toxic Substances Control Act (TSCA). The draft scope document includes the conditions of use, hazards, exposures, and the potentially exposed or susceptible subpopulations that EPA plans to consider in conducting the risk evaluation for this chemical substance. EPA is also opening a 45-calendar day comment period on the draft scope to allow for the public to provide additional data or information that could be useful in preparing the final scope document. Comments are due October 25, 2021.
 
EPA plans to evaluate manufacturing (including importing); processing; distribution in commerce; industrial, commercial, and consumer uses; and disposal of D4 in the risk evaluation. According to the draft scope document, D4 is manufactured (including imported) in the United States. The chemical is processed as a reactant; incorporated into a formulation, mixture, or reaction product; and incorporated into articles. The draft scope document states that the identified processing activities also include the repackaging and recycling of D4. D4 is primarily used to make other silicone chemicals and as an ingredient in consumer products regulated by the Federal Food, Drug, and Cosmetic Act (FFDCA). Commercial uses include adhesives and sealants, automotive care products, paints and coatings, and other plastic and rubber products. Additional consumer uses include adhesives and sealants, automotive care products, laundry and dishwashing products, paints and coatings, and other plastic and rubber products.
 
EPA notes that some of these conditions of use were identified in the manufacturer request as circumstances on which EPA was requested to conduct a risk evaluation. EPA identified other conditions of use from information reported to EPA through Chemical Data Reporting (CDR), published literature, and consultation with stakeholders for both uses currently in production and uses whose production may have ceased. EPA presented the proposed additions of these EPA-identified conditions of use and the basis for these proposed additions, along with the manufacturer request, for a 45-day comment period in June 2020.


 

By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) granted on October 6, 2020, a manufacturer request for a risk evaluation of octamethylcyclotetra-siloxane (D4), a chemical used to make other silicone chemicals and as an ingredient in some personal care products.  Through the American Chemistry Council’s Silicones Environmental, Health, and Safety Center, Dow Silicones Corporation, Elkem Silicones USA Corporation, Evonik Corporation, Momentive Performance Materials, Shin-Etsu Silicones of America, Inc., and Wacker Chemical Corporation requested a risk evaluation of D4 pursuant to Section 6 of the Toxic Substances Control Act (TSCA).  For manufacturer-requested risk evaluations under TSCA Section 6, the manufacturers requesting the risk evaluation are responsible for payment of the associated fees.  The fee for a manufacturer-requested risk evaluation of a chemical included in the 2014 update to the TSCA Work Plan is 50 percent of total actual costs, with a $1,250,000 initial payment.  D4 is included in the 2014 update to the TSCA Work Plan.  EPA notes that if the request is not withdrawn within 30 days, D4 will enter the TSCA risk evaluation process.


 

By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) announced on June 12, 2020, that it is opening a public comment period for a manufacturer-requested risk evaluation of octamethylcyclotetra-siloxane (D4), a chemical used to make other silicone chemicals and as an ingredient in some personal care products.  EPA states that the manufacturer-requested risk evaluation of D4 is the third evaluation of this kind to be requested under the amended Toxic Substances Control Act (TSCA).  EPA will publish a notice in the Federal Register announcing the public comment period and beginning a 45-day comment period.  EPA “welcomes all public comments on this request, particularly on the following”:

  • Any information not included in the manufacturer request that the commenters believe EPA would need to conduct a risk evaluation;
  • Additional conditions of use the Agency 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 is proposing to include in the risk evaluation.

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.  EPA has opened Docket ID EPA-HQ-OPPT-2018-0443 for the request.


 

By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) announced on April 8, 2020, that it received a complete manufacturer request for EPA to conduct a risk evaluation of octamethylcyclotetrasiloxane (D4) from Dow Silicones Corporation, Elkem Silicones USA Corporation, Evonik Corporation, Momentive Performance Materials, Shin-Etsu Silicones of America, Inc., and Wacker Chemical Corporation through the American Chemistry Council’s Silicones Environmental, Health, and Safety Center.  EPA states that D4 is used to make other silicone chemicals and as an ingredient in some personal care products.  D4 was identified in the 2014 Update to the TSCA Work Plan.
 
EPA notes that within 15 business days of receiving a facially complete request (i.e., submission appears to be consistent with rule requirements), it must notify the public of receipt of this request under 40 C.F.R. Section 702.37(e)(2).  Within 60 business days of receipt of a facially complete request, EPA will submit for publication the receipt of the request in the Federal Register, open a public docket for the request, and provide no less than 45 calendar days for public comment.  According to EPA, the docket will contain the manufacturer request, EPA’s proposed additions of conditions of use, and the basis for those proposed additions.  During the public comment period, the public may comment on the request, as well as the additional conditions of use EPA proposes for inclusion.  After the comment period closes, EPA has up to 60 days to either grant or deny the request to conduct a risk evaluation under 40 C.F.R. Section 702.37(e)(6).