2018-21747. A Working Approach for Identifying Potential Candidate Chemicals for Prioritization; Notice of Availability

AGENCY:

Environmental Protection Agency (EPA).

ACTION:

Notice.

SUMMARY:

This Notice announces the availability of a document: A Working Approach for Identifying Potential Candidate Chemicals for Prioritization. The document lays out EPA's near-term approach for identifying potential chemicals for prioritization, the initial step in evaluating the safety of existing chemicals under the Toxic Substances Control Act (TSCA). The document also includes a longer-term risk-based approach for considering the larger TSCA active chemical universe. EPA is opening a public docket to accept comments on this approach, which will inform a public meeting to be held in early 2019. This docket will remain open until November 15, 2018. In a related but separate action, EPA is opening 74 public dockets, one for each of the 73 remaining chemicals on the 2014 Update to the TSCA Work Plan for Chemical Assessments that have not received manufacturer requests for EPA evaluation and an additional general docket for chemicals not on the Work Plan. These dockets will be open until December 1, 2019.

FOR FURTHER INFORMATION CONTACT:

 

For technical information on A Working Approach for Identifying Potential Candidate Chemicals for Prioritization document contact: Susanna Blair, Office of Pollution Prevention and Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-0001; telephone number: [phone]; email address: [e-mail].

For general information contact: The TSCA-Hotline, ABVI-Goodwill, 422 South Clinton Ave., Rochester, NY 14620; telephone number: [phone]; email address: [e-mail].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

This action is directed to the public in general, and may be of interest to a wide range of stakeholders including chemical manufacturers, processors and users, consumer product companies, non-profit organizations in the environmental and public health sectors, state and local government agencies, and members of the public interested in the environmental and human health assessment and regulation of chemical substances. Since others also may be interested, the Agency has not attempted to describe all the specific entities that may be affected by this action.

B. What action is the Agency taking?

EPA is taking three actions: Announcing the availability of a document, announcing the opening of a docket to accept comments on the longer-term strategy described in the document, and announcing the opening of chemical-specific public dockets and a general docket to collect information on potential candidate chemicals for prioritization for risk evaluation under TSCA.

This Notice announces the availability of a document: A Working Approach for Identifying Potential Candidate Chemicals for Prioritization. The document lays out EPA's near-term approach for identifying potential chemicals for prioritization, the initial step in evaluating the safety of existing chemicals under TSCA. The document also includes a longer-term approach for considering the larger TSCA active chemical universe. The document is available at EPA's website at https://www.epa.gov/​assessing-and-managing-chemicals-under-tsca/​prioritizing-existing-chemicals-risk-evaluation.

EPA is opening a public docket to accept comments on this longer-term approach, which will inform a public meeting to be held in early 2019. This docket, identified by docket ID EPA-HQ-OPPT-2018-0659, will remain open until November 15, 2018.

In a separate but related action, EPA is opening 74 public dockets, one for each of the 73 remaining chemicals on the 2014 Update to the TSCA Work Plan for Chemical Assessments that have not received manufacturer requests for EPA evaluation and an additional general docket for chemicals not on the Work Plan. These dockets will be open until December 1, 2019. More details about these dockets is in Unit II.B.

C. What is the Agency's authority for this action?

As amended in June 2016, TSCA requires that EPA prioritize and evaluate existing chemical substances and manage identified risks (15 U.S.C. 2605). This Notice is issued pursuant to the authority in TSCA section 6(b), 15 U.S.C. 2605(b).

II. Background

The Frank R. Lautenberg Chemical Safety for the 21st Century Act, amending the TSCA of 1976, was signed into law on June 22, 2016. The amendments required that EPA establish procedures for prioritizing and evaluating risks from existing chemical substances. EPA announced its final procedures on June 22, 2017 (see https://www.epa.gov/​assessing-and-managing-chemicals-under-tsca/​federal-register-notice-procedures-prioritization), and the final procedural rule addressing the prioritization process published in the Federal Register on July 20, 2017 (82 FR 33753) (FRL-9964-24).

A. A Working Approach for Identifying Potential Candidate Chemicals for Prioritization

The document described in this Notice lays out EPA's near-term approach for identifying potential chemicals for prioritization, the initial step in evaluating the safety of existing chemicals under TSCA. Building on the Agency's commitment to work with the public to select the next chemicals for risk evaluation, this approach reflects public input received at a December 2017 meeting (82 FR 51415) (FRL-9970-34) and through the public docket for that meeting (EPA-HQ-OPPT-2017-0587). By December 2019, EPA must designate at least 20 chemical substances as High-Priority for risk evaluation, and 20 chemical substances as Low-Priority for which risk evaluation is not currently warranted.

The information set forth in the document, A Working Approach for Identifying Potential Candidate Chemicals for Prioritization, describes the general approaches EPA may consider for identifying existing chemicals as potential candidates for prioritization. The goal of these approaches is to identify potential candidates from which EPA will select candidates for prioritization, consistent with its regulations at 40 CFR 702.5.

The document describes the near-term approach that EPA anticipates using to inform the identification of potential candidates for the initial 20 High-Priority and 20 Low-Priority chemical substances that must be identified pursuant to TSCA section 6(b)(2)(B). The document also presents a longer-term approach that EPA is considering. EPA encourages public comments on these approaches and has opened dockets to receive public comments.

The document presents internal guidance for EPA, and neither constitutes rulemaking by EPA nor can be relied on to create a substantive or procedural right enforceable by any party in litigation with the United States. It provides recommendations and does not impose any legally binding requirements. Similarly, statements about what EPA expects or intends to do reflect general principles to guide EPA's activities and not judgments or determinations as to what EPA will do in any particular case.

B. Dockets To Collect Information on Potential Candidate Chemicals for Prioritization for Risk Evaluation

As explained in the Procedures for Prioritization of Chemicals for Risk Evaluation Under the Toxic Substances Control Act Final rule published in the Federal Register on July 20, 2017 (82 FR 33753) (FRL-9964-24), EPA intends to foster a dialogue with stakeholders by publishing a notice explaining why it chose to initiate the prioritization process on particular chemical substances and to seek relevant information from the public. In support of that intention, EPA is opening 74 public dockets, one for each of the 73 remaining chemicals on the 2014 Update to the TSCA Work Plan for Chemical Assessments that have not received manufacturer requests for EPA evaluation and an additional general docket for the public to suggest chemicals EPA should prioritize for risk evaluation.

By providing the public with a venue for submitting use, hazard, and exposure information on these chemicals, EPA is facilitating the sharing of information by stakeholders and the general public that could update the information EPA currently has on the chemicals on the 2014 Update to the TSCA Work Plan for Chemical Assessments. EPA will use this data to inform TSCA prioritization and risk evaluation for these chemicals.

EPA is also opening dockets for input on chemicals not on the 2014 Update to the TSCA Work Plan for Chemical Assessments. EPA expects that the dockets will increase transparency of the process.

The list of chemical dockets is in this section. Additional information, such as the docket numbers for each chemical, the chemical's Chemical Abstract Services Registry Number, and the EPA points of contact can be found at http://www.epa.govADDURLXXX. EPA is opening these dockets to receive information from the public. Information should be submitted by December 1, 2019. When you submit your information, please identify the docket identification (ID) number associated with the relevant chemical. Additional instructions on providing information or visiting the docket, along with more information about dockets generally, is available in each docket and at http://www.epa.gov/​dockets. When preparing and submitting your information, see the tips at http://www2.epa.gov/​dockets/​commenting-epa-dockets#tips.

The chemicals as listed on the 2014 Update to the TSCA Work Plan for Chemical Assessments and the respective docket numbers are:

• Acetaldehyde (EPA-HQ-OPPT-2018-0497).
• Acrylonitrile (EPA-HQ-OPPT-2018-0449).
• tert-Amyl methyl ether (EPA-HQ-OPPT-2018-0463).
• Antimony and Antimony Compounds (EPA-HQ-OPPT-2018-0470).
• Arsenic and Arsenic Compounds (EPA-HQ-OPPT-2018-0472).
• Barium Carbonate (EPA-HQ-OPPT-2018-0473).
• Benzenamine (EPA-HQ-OPPT-2018-0474).
• Benzene (EPA-HQ-OPPT-2018-0475).
• Bisphenol A (BPA) (EPA-HQ-OPPT-2018-0500).
• 1,3-Butadiene (EPA-HQ-OPPT-2018-0451).
• Butanamide, 2,2′-[(3,3′- dichloro[1,1′- biphenyl]- 4,4′-diyl)bis(azo)]bis[N- (4-chloro-2,5 dimethoxyphenyl)-3-oxo- (Pigment Yellow 83) (EPA-HQ-OPPT-2018-0477).
• Butanamide, 2-[(4- methoxy-2-nitrophenyl) azo]-N-(2- methoxyphenyl)-3-oxo- (Pigment Yellow 65) (EPA-HQ-OPPT-2018-0478).
• Butyl benzyl phthalate (BBP) 1,2-Benzene- dicarboxylic acid, 1- butyl 2(phenylmethyl) ester (EPA-HQ-OPPT-2018-0501).
• 4-sec-Butyl-2,6-di-tert- butylphenol (EPA-HQ-OPPT-2018-0495).
• Cadmium and Cadmium Compounds (EPA-HQ-OPPT-2018-0479).
• Chromium and Chromium Compounds (EPA-HQ-OPPT-2018-0480).
• Cobalt and Cobalt Compounds (EPA-HQ-OPPT-2018-0481).
• Creosotes (EPA-HQ-OPPT-2018-0502).
• Cyanide Compounds (Limited to dissociable compounds) (EPA-HQ-OPPT-2018-0482).
• Dibutyl phthalate (DBP) (1,2-Benzene- dicarboxylic acid, 1,2- dibutyl ester) (EPA-HQ-OPPT-2018-0503).
• o-Dichlorobenzene (EPA-HQ-OPPT-2018-0444).
• p-Dichlorobenzene (EPA-HQ-OPPT-2018-0446).
• 3,3′-Dichlorobenzidine (EPA-HQ-OPPT-2018-0494).
• 3,3′-Dichlorobenzidine dihydrochloride (EPA-HQ-OPPT-2018-0493).
• 1,1-Dichloroethane (EPA-HQ-OPPT-2018-0426).
• 1,2-Dichloroethane (EPA-HQ-OPPT-2018-0427).
• trans-1,2- Dichloroethylene (EPA-HQ-OPPT-2018-0465).
• 1,2-Dichloropropane (EPA-HQ-OPPT-2018-0428).
• Dicyclohexyl phthalate (EPA-HQ-OPPT-2018-0504).
• Di-ethylhexyl phthalate (DEHP) (1,2-Benzene- dicarboxylic acid, 1,2- bis(2-ethylhexyl) ester (EPA-HQ-OPPT-2018-0433).
• Di-isobutyl phthalate (DIBP) (1,2-Benzene- dicarboxylic acid, 1,2- bis-(2methylpropyl) ester) (EPA-HQ-OPPT-2018-0434).
• Di-isodecyl phthalate (DIDP) (1,2-Benzene- dicarboxylic acid, 1,2- diisodecyl ester) (EPA-HQ-OPPT-2018-0435).
• Di-isononyl phthalate (DINP) (1,2-Benzene- dicarboxylic acid, 1,2- diisononyl ester) (EPA-HQ-OPPT-2018-0436).
• 1,2-Dimethoxyethane (Monoglyme) (EPA-HQ-OPPT-2018-0429).
• 2-Dimethylaminoethanol (EPA-HQ-OPPT-2018-0489).
• Di-n-octyl phthalate (DnOP) (1,2-Benzene- dicarboxylic acid, 1,2- dioctyl ester) (EPA-HQ-OPPT-2018-0437).
• Ethanone, 1- (1,2,3,4,5,6,7,8- octahydro-2,3,5,5- tetramethyl-2- naphthalenyl)- (EPA-HQ-OPPT-2018-0483).
• Ethanone, 1- (1,2,3,4,5,6,7,8- octahydro-2,3,8,8- tetramethyl-2- naphthalenyl)- (EPA-HQ-OPPT-2018-0484).
• Ethanone, 1- (1,2,3,4,6,7,8,8a-octahydro- 2,3,8,8- tetramethyl-2- naphthalenyl)- (EPA-HQ-OPPT-2018-0485).
• Ethanone, 1- (1,2,3,5,6,7,8,8a-octahydro- 2,3,8,8- tetramethyl-2- naphthalenyl)- (EPA-HQ-OPPT-2018-0486).
• Ethylbenzene (EPA-HQ-OPPT-2018-0487).
• Ethylene dibromide (EPA-HQ-OPPT-2018-0488).
• bis(2-Ethylhexyl) adipate (EPA-HQ-OPPT-2018-0499).
• 2-Ethylhexyl 2,3,4,5- tetrabromobenzoate (TBB) (EPA-HQ-OPPT-2018-0491).
• bis(2-Ethylhexyl)-3,4,5,6-tetrabromophthalate (TBPH) (EPA-HQ-OPPT-2018-0498).
• Formaldehyde (EPA-HQ-OPPT-2018-0438).
• 2,5-Furandione (EPA-HQ-OPPT-2018-0471).
• 1-Hexadecanol (EPA-HQ-OPPT-2018-0469).
• 1,3,4,6,7,8-Hexahydro-4,6,6,7,8,8- hexamethylcyclopenta [g]-2-benzopyran (HHCB) (EPA-HQ-OPPT-2018-0430).
• 2-Hydroxy-4-(octyloxy) benzophenone (EPA-HQ-OPPT-2018-0492).
• Lead and Lead Compounds (EPA-HQ-OPPT-2018-0452).
• Long-chain chlorinated paraffins (C18-20) (EPA-HQ-OPPT-2018-0439).
• Medium-chain chlorinated paraffins (C14-17) (EPA-HQ-OPPT-2018-0440).
• 4,4′-Methylene bis(2- chloroaniline) (EPA-HQ-OPPT-2018-0464).
• 4,4′-(1-Methylethylidene)bis[2, 6-dibromophenol] (TBBPA) (EPA-HQ-OPPT-2018-0462).
• Molybdenum and Molybdenum Compounds (EPA-HQ-OPPT-2018-0453).
• Naphthalene (EPA-HQ-OPPT-2018-0454).
• 2- Naphthalenecarboxylic acid, 4-[(4-chloro-5- methyl-2-sulfophenyl) azo]-3-hydroxy-, calcium salt (1:1) (Pigment Red 52) (EPA-HQ-OPPT-2018-0460).
• Nickel and Nickel Compounds (EPA-HQ-OPPT-2018-0455).
• N-Nitroso- diphenylamine (EPA-HQ-OPPT-2018-0456).
• Nonylphenol and Nonylphenol Ethoxylates (NP/NPEs) (EPA-HQ-OPPT-2018-0442).
• Octamethylcyclotetra- siloxane (D4) (EPA-HQ-OPPT-2018-0443).
• 4-tert-Octylphenol (4-(1,1,3,3-Tetramethylbutyl)- phenol) (EPA-HQ-OPPT-2018-0496).
• p,p′- Oxybis(benzenesulfonyl hydrazide) (EPA-HQ-OPPT-2018-0457).
• Phosphoric acid, triphenyl ester (TPP) (EPA-HQ-OPPT-2018-0458).
• Phthalic anhydride (EPA-HQ-OPPT-2018-0459).
• Styrene (EPA-HQ-OPPT-2018-0461).
• Tribromomethane (Bromoform) (EPA-HQ-OPPT-2018-0466).
• 1,1,2-Trichloroethane (EPA-HQ-OPPT-2018-0421).
• Triglycidyl isocyanurate (EPA-HQ-OPPT-2018-0467).
• Tris(2-chloroethyl) phosphate (TCEP) (EPA-HQ-OPPT-2018-0476).
• Vinyl chloride (EPA-HQ-OPPT-2018-0448).
• m-Xylene (EPA-HQ-OPPT-2018-0441).
• o-Xylene (EPA-HQ-OPPT-2018-0445).
• p-Xylene (EPA-HQ-OPPT-2018-0447).

In addition, EPA is interested in the public's input on chemicals not on the 2014 Update to the TSCA Work Plan for Chemical Assessments for consideration as potential candidates for prioritization under TSCA. EPA welcomes the submittal of information to the docket that would support the consideration of the chemicals suggested, such as information on use, hazard, and exposure. EPA is opening docket number EPA-HQ-OPPT-2018-0592 for this purpose.

Authority: 15 U.S.C. 2601 et seq.

Dated: September 27, 2018.

Jeffery T. Morris,

Director, Office of Pollution Prevention and Toxics.