[Federal Register Volume 84, Number 164 (Friday, August 23, 2019)]
[Notices]
[Pages 44300-44303]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-18134]


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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPPT-2019-0131; FRL-9998-29]


Proposed High-Priority Substance Designations Under the Toxic 
Substances Control Act (TSCA); Notice of Availability and Request for 
Comment

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: As required under section 6(b) of the Toxic Substances Control 
Act (TSCA) and implementing regulations, EPA is proposing to designate 
20 chemical substances as High-Priority Substances for risk evaluation. 
This document and supporting docket materials identify the proposed 
designation for each of the chemical substances and instructions on how 
to access the chemical-specific information, analysis and basis used by 
EPA to support the proposed designation for each chemical substance. 
EPA is providing a 90-day comment period during which interested 
persons may provide comments on the proposed designations of High-
Priority Substances for risk evaluation.August 22, 2019

DATES: Comments must be received on or before November 21, 2019.

ADDRESSES: Use one of the following methods to submit comments. For 
comments not related to a specific chemical, including comments on Unit 
V., direct your comments to docket identification (ID) number EPA-HQ-
OPPT-2019-0131. For comments on one or more of the 20 chemical 
substances, use the applicable chemical specific docket ID number(s) 
identified in Unit IV.B.:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the online instructions for submitting comments. Do not submit 
electronically any information you consider to be Confidential Business 
Information (CBI) or other information whose disclosure is restricted 
by statute.
     Mail: Document Control Office (7407M), Office of Pollution 
Prevention and Toxics (OPPT), Environmental Protection Agency, 1200 
Pennsylvania Ave. NW, Washington, DC 20460-0001.
     Hand Delivery: To make special arrangements for hand 
delivery or delivery of boxed information, please follow the 
instructions at http://www.epa.gov/dockets/contacts.html.
    Additional instructions on commenting or visiting the docket, along 
with more information about dockets generally, is available at http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: For technical information about the 
High-Priority Substances contact: Ana Corado, Chemical Control 
Division, Office of Pollution Prevention and Toxics, Office of Chemical 
Safety and Pollution Prevention, Environmental Protection Agency 
(Mailcode 7408M), 1200 Pennsylvania Ave. NW, Washington, DC 20460-0001; 
telephone number: (202) 564-0140; email address: [email protected].
    For general information contact: The TSCA-Hotline, ABVI-Goodwill, 
422 South Clinton Ave., Rochester, NY 14620; telephone number: (202) 
554-1404; email address: [email protected].

I. Executive Summary

A. Does this action apply to me?

    This action is directed to the public in general and may be of 
interest to entities that currently or may manufacture (including 
import) a chemical substance regulated under TSCA (e.g., entities 
identified under North American Industrial Classification System 
(NAICS) codes 325 and 324110). The action may also be of interest to 
chemical processors, distributors in commerce, and users; non-
governmental organizations in the environmental and public health 
sectors; state and local government agencies; and members of the 
public. Since other entities may also be interested, the Agency has not 
attempted to describe all the specific entities and corresponding NAICS 
codes for entities that may be interested in or affected by this 
action.

B. What action is the Agency taking?

    EPA is proposing to designate 20 chemical substances as High-
Priority Substances for risk evaluation pursuant to section 6(b) of the 
Toxic Substances Control Act (TSCA), 15 U.S.C. 2605(b). This document 
includes a summary of the approach used by EPA to support the proposed 
designations, the proposed designation for each of the chemical

[[Page 44301]]

substances, and instructions on how to access the chemical-specific 
information, analysis and basis used by EPA to make the proposed 
designation for each chemical substance. EPA is providing a 90-day 
comment period during which interested persons may submit comments on 
the proposed designations.

C. Why is the Agency taking this action?

    TSCA section 6(b) and EPA implementing regulations at 40 CFR 702.9 
require EPA to carry out a prioritization process for chemical 
substances that may be designated as high priority for risk evaluation. 
TSCA section 6(b)(2)(B) requires that EPA be conducting risk 
evaluations on at least 20 High-Priority Substances no later than three 
and one-half years after the date of enactment of the Frank R. 
Lautenberg Chemical Safety for the 21st Century Act (Pub. L. 114-182). 
EPA is proposing to designate as High-Priority Substances for risk 
evaluation the same 20 chemical substances for which EPA initiated the 
prioritization process required by TSCA section 6(b) on March 21, 2019 
(Ref. 1). EPA is providing a 90-day comment period during which the 
public may submit comments on EPA's proposed designations of High-
Priority Substances for risk evaluation, as required by TSCA section 
6(b)(1)(C)(ii) and implementing regulations (40 CFR 702.9(g)).

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

    This document is issued pursuant to TSCA section 6(b)(1).

E. What are the estimated incremental impacts of this action?

    This document identifies 20 chemical substances for proposed 
designation as High-Priority Substances for risk evaluation. This 
document does not establish any requirements on persons or entities 
outside of the Agency. No incremental impacts are therefore 
anticipated, and consequently, EPA did not estimate potential 
incremental impacts for this action.

F. What should I consider as I prepare my comments for EPA?

    1. Submitting Confidential Business Information (CBI). Do not 
submit this information to EPA through regulations.gov or email. 
Clearly mark the part or all of the information that you claim to be 
CBI. For CBI in a disk or CD-ROM that you mail to EPA, mark the outside 
of the disk or CD-ROM as CBI and then identify electronically within 
the disk or CD-ROM the specific information that is claimed as CBI. In 
addition to one complete version of the comment that includes 
information claimed as CBI, a copy of the comment that does not contain 
the information claimed as CBI must be submitted for inclusion in the 
public docket. Information so marked will not be disclosed except in 
accordance with procedures set forth in 40 CFR part 2.
    2. Tips for preparing your comments. When preparing and submitting 
your comments, see the commenting tips at http://www.epa.gov/dockets/comments.html.

II. Background

    TSCA section 6(b)(1) requires EPA to prioritize chemical substances 
for risk evaluation. As required by TSCA section 6(b) and described in 
40 CFR 702.7, on March 21, 2019 (Ref. 1) EPA initiated the 
prioritization process for 20 chemical substances identified as 
candidates for High-Priority Substance designation.
    Under TSCA section 6(b)(1)(B) and implementing regulations (40 CFR 
702.3), a High-Priority Substance is defined as a chemical substance 
that EPA determines, without consideration of costs or other non-risk 
factors, may present an unreasonable risk of injury to health or the 
environment because of a potential hazard and a potential route of 
exposure under the conditions of use, including an unreasonable risk to 
potentially exposed or susceptible subpopulations identified as 
relevant by EPA.
    A proposed designation of a substance as a High-Priority Substance 
is not a finding of unreasonable risk. Rather, when prioritization is 
complete, for those chemicals designated as High-Priority Substances, 
the Agency will have evidence that the substances may present an 
unreasonable risk of injury to health or the environment because of a 
potential hazard and a potential route of exposure under the conditions 
of use. Final designation of a High-Priority Substance initiates the 
risk evaluation process (40 CFR 702.17), which culminates in a finding 
of whether or not the chemical substance presents an unreasonable risk 
of injury to health or the environment under the conditions of use.
    This document is intended to fulfill the requirement in TSCA 
section 6(b)(1)(C)(ii) that the Administrator propose the designation 
of 20 chemical substances as High-Priority Substances for risk 
evaluation after conducting a review, as required by TSCA section 
6(b)(1)(A) (see also 40 CFR 702.9(a)). This document is also intended 
to fulfill the requirement in TSCA section 6(b)(1)(C)(ii) that the 
Administrator request public comments on proposed priority designations 
(see also 40 CFR 702.9(g)).
    EPA generally used reasonably available information to screen the 
candidate chemical substances against the following criteria and 
considerations (40 CFR 702.9(a)):
     The chemical substance's hazard and exposure potential;
     The chemical substance's persistence and bioaccumulation;
     Potentially exposed or susceptible subpopulations;
     Storage of the chemical substance near significant sources 
of drinking water;
     The chemical substance's conditions of use or significant 
changes in conditions of use;
     The chemical substance's production volume or significant 
changes in production volume; and
     Other risk-based criteria that EPA determines to be 
relevant to the designation of the chemical substance's priority.
    As described in 40 CFR 702.9(b), in conducting the review during 
the prioritization process, EPA considered sources of information 
relevant to the review criteria as outlined in the statute (TSCA 
section 6(b)(1)(A)) and implementing regulations (40 CFR 702.9(a)) and 
consistent with the scientific standards of TSCA section 26(h), 
including, as appropriate, sources for hazard and exposure data listed 
in Appendices A and B of the TSCA Work Plan Chemicals: Methods Document 
(February 2012). In addition, as required by 40 CFR 702.9, EPA 
considered the hazard and exposure potential of the chemical substances 
and did not consider costs or other non-risk factors in making a 
proposed priority designation.

III. Information and Comments Received

    The initiation of the prioritization process (Ref. 1) included a 
90-day comment period during which interested persons were able to 
submit relevant information on the 20 chemical substances identified as 
candidates for High-Priority Substance designation. EPA received 125 
submissions from commenters, including private citizens, potentially 
affected businesses, trade associations, environmental and public 
health advocacy groups, and academia. Comments addressed the overall 
prioritization process (e.g., the collection and consideration of 
relevant information), the review process (e.g., the use of data and 
approaches in risk evaluation), information specific to the candidate 
chemical substances (e.g.,

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relevant studies, assessments and conditions of use), and topics not 
germane to this prioritization process (e.g., scheduling future 
chemicals for prioritization and concerns about risk evaluation fees). 
To the extent that comments provided information on additional 
conditions of use for these candidate High-Priority chemical 
substances, those conditions of use are discussed in the proposed 
designation documents for each chemical substance. EPA will respond to 
those and any additional comments in conjunction with the final 
priority designation of these chemical substances.

IV. Chemical Substances for Which EPA Is Proposing a High-Priority 
Substance Designation for Prioritization

A. Information, Analysis and Basis Used To Support the Proposed High-
Priority Substance Designation

    EPA used reasonably available information, including public 
comments received during the 90-day comment period following initiation 
of the prioritization process (Ref. 1), to analyze the candidate 
chemical substances against the criteria and considerations in TSCA 
section 6(b)(1)(A) and 40 CFR 702.9 (see Unit III.). EPA developed a 
document for each substance to identify the information, analysis and 
basis used to support the proposed designations as a High-Priority 
Substance for risk evaluation. These documents are available in the 
docket of each of the chemical substances with a proposed designation 
as a High-Priority Substance for risk evaluation. The proposed 
designations and docket references are presented in Unit IV.B., along 
with the docket references.
    Also included in each document is an explanation of the approach 
used by EPA to conduct the review. Each of the documents includes an 
overview of the requirements in TSCA section 6(b)(1)(A) and the 
regulatory section addressing the following review criteria and 
considerations (40 CFR 702.9):
    1. Production volume or significant changes in production volume. 
EPA considered reasonably available information on the current volume 
or significant changes in volume of the chemical substance using 
reported information from manufacturers (including importers) under the 
Chemical Data Reporting (CDR) rule. EPA assembled information reported 
to the Agency from 1986 through 2016 on the production volume under the 
Inventory Update Rule (IUR) and CDR. The most recent principal 
reporting year for which CDR data are available is 2015 information, 
reported in 2016.
    2. Conditions of use or significant changes in conditions of use. 
EPA assembled information on conditions of use or significant changes 
in conditions of use of the chemical substance using reported CDR data, 
the Toxics Release Inventory (TRI) and chemical-specific information 
received from public commenters. TSCA section 3(4) defines the term 
``conditions of use'' to mean the circumstances, as determined by the 
Administrator, under which a chemical substance is intended, known, or 
reasonably foreseen to be manufactured, processed, distributed in 
commerce, used, or disposed of. For CDR data, EPA assembled information 
submitted by manufacturers (including importers) under the 2012 and 
2016 CDR reporting cycles. CDR requires manufacturers (including 
importers) to report information on the chemical substances they 
produce domestically or import into the United States, generally more 
than 25,000 lbs per site. For candidate priority chemicals included on 
the TRI chemical list, information disclosed by reporting facilities in 
part II Section 3 (``Activities and Uses of the Toxic Chemical at the 
Facility'') of their TRI Form R reports was used to supplement the CDR 
information on conditions of use. In addition to the information 
disclosed in part II Section 3 of the TRI Form R, information 
pertaining to waste management activities (e.g., disposal, treatment, 
recycling) disclosed in other sections of the TRI Form R was also used 
to supplement the CDR information on conditions of use. Based on the 
manufacturing information, industrial processing and use information, 
and consumer and commercial use information reported under CDR and TRI 
as well as information associated with waste management activities 
reported under TRI, as well as chemical-specific information received 
from public commenters, EPA developed a list of conditions of use from 
data reported during the 2012 and 2016 CDR reporting cycles and the 
2011, 2015, and 2017 TRI reporting cycles, as appropriate. Should the 
Agency decide to make a final decision to designate a chemical 
substance as a high-priority substance for risk evaluation, further 
characterization of relevant TSCA conditions of use will be identified 
during the risk evaluation process as part of EPA's scope document.
    3. Potentially exposed or susceptible subpopulations. In this 
review, EPA considered reasonably available information to identify 
potentially exposed or susceptible subpopulations. At this stage, EPA 
analyzed information regarding children, women of reproductive age, and 
workers (note that consumers are considered as part of the criterion 
for ``7. Exposure potential''):
     For children, EPA evaluated the chemical substance's use 
in products and articles regulated under TSCA and intended for 
children, using CDR information reported during the 2012 and 2016 CDR 
cycles. EPA presented information regarding those commercial and 
consumer uses where the chemical substance was used in products 
intended for children. EPA also identified the potential for 
developmental hazards that could negatively impact children.
     For women of reproductive age (e.g., pregnant women) EPA 
identified exposure conditions and hazard information for the chemical 
substance which indicated potential for reproductive or developmental 
adverse effects.
     For workers, EPA identified the potential for occupational 
exposures to workers based on the conditions of use of each chemical.
    4. Persistence and bioaccumulation. EPA considered reasonably 
available information of the chemical substance and assessed physical-
chemical properties for persistence and bioaccumulation based on best 
available science. EPA presented a summary of the physical and chemical 
properties and the environmental fate characteristics of each chemical 
substance.
    5. Storage near significant sources of drinking water. To support 
the proposed designation, EPA analyzed each chemical substance, under 
its conditions of use, with respect to the seven criteria in TSCA 
section 6(b)(1)(A) and 40 CFR 702.9. The statute specifically requires 
the Agency to consider the chemical substance's storage near 
significant sources of drinking water, which EPA interprets as 
direction to focus on the chemical substance's potential human health 
hazard and exposure. EPA reviewed reasonably available information, 
specifically looking to identify certain types of existing regulations 
or protections for the proposed chemical substances. EPA considered the 
chemical substance's potential human health hazards, including to 
potentially exposed or susceptible subpopulations, by identifying 
existing National Primary Drinking Water Regulations (40 CFR part 141) 
and other regulations under the CWA (40 CFR 401.15). In addition, EPA 
considered the consolidated list of chemicals subject to reporting 
requirements under the EPCRA (Section 302 Extremely Hazardous 
Substances

[[Page 44303]]

and Section 313 Toxic Chemicals), CERCLA (Hazardous Substances), and 
the CAA (Section 112(r) Regulated Chemicals for Accidental Release 
Prevention). Regulation by one of these authorities is an indication 
that the substance is a potential health or environmental hazard which, 
if released near a significant source of drinking water, could present 
unreasonable risk to health or the environment.
    6. Hazard potential. EPA considered reasonably available 
information to identify potential hazards for each chemical substance. 
EPA surveyed information from previous peer-reviewed assessments and 
databases and summarized the reasonably available information for 
potential human health and environmental hazards by endpoints of 
concern. If endpoint-specific hazard information was not available for 
the chemical substance subject to the review, then EPA considered 
isomer analog data.
    7. Exposure potential. EPA considered reasonably available 
information to identify potential environmental, worker/occupational, 
consumer, and general population exposures for each chemical substance:
     For environmental exposures, EPA considered the conditions 
of use and activities associated with those conditions of use and 
considered monitoring data and fate properties of each chemical 
substance to anticipate its presence in different environmental media.
     For worker or occupational exposure, EPA identified the 
conditions of use that are likely to result in workers exposures, such 
as manufacturing, processing, industrial and commercial use, 
distribution in commerce, and disposal.
     For consumer exposure, EPA identified consumer uses using 
CDR information, information from the NIH Household Products Database 
and the EPA's Chemical and Products Database (CPDat).
     For general population exposure, EPA considered releases 
from certain conditions of use as reported in TRI, such as 
manufacturing, that may result in general population exposures via 
drinking water ingestion and/or inhalation from air releases.
    8. Other risk-based criteria that EPA determined to be relevant to 
the designation of the chemical substance's priority. EPA did not 
identify other risk-based criteria relevant to the proposed 
designations of the candidate chemical substances as High-Priority 
Substance for risk evaluation.

B. Proposed Designation as High-Priority Substances for Risk Evaluation

    EPA is proposing to designate the 20 chemicals listed in Unit IV.C. 
as High-Priority Substances for risk evaluation. The proposed 
designations are based on the conclusion that the chemical substance 
satisfies the definition of High-Priority Substance in TSCA section 
6(b)(1)(B) and 40 CFR 702.3. As mentioned previously, a proposed 
designation of a chemical substance as a High-Priority Substance is not 
a finding of unreasonable risk; rather, when prioritization is 
complete, a final designation as a High-Priority Substance will 
initiate the risk evaluation for the chemical substance, which will 
culminate in a finding of whether or not the chemical substance 
presents an unreasonable risk to health or the environment under the 
conditions of use. Based on the information provided in the Proposed 
Designation documents, the Agency is proposing the chemical substances 
listed in Unit IV.C. as High-Priority Substances for risk evaluation. 
The chemical-specific designation documents containing the information, 
analysis and basis used to support the proposed designation are located 
in the docket for each chemical substance.

C. Request for Comments

    EPA is interested in comments that would inform the exposure and 
hazard assessments and the identification of conditions of use for the 
following chemicals:

    1. 1,3-Butadiene, CASRN 106-99-0, Docket ID number: EPA-HQ-OPPT-
2018-0451.
    2. Butyl benzyl phthalate (BBP) (1,2-Benzenedicarboxylic acid, 
1-butyl 2-(phenylmethyl) ester), CASRN 85-68-7, Docket ID number: 
EPA-HQ-OPPT-2018-0501.
    3. Dibutyl phthalate (DBP) (1,2-Benzenedicarboxylic acid, 1,2-
dibutyl ester), CASRN 84-74-2, Docket ID number: EPA-HQ-OPPT-2018-
0503.
    4. o-Dichlorobenzene (Benzene, 1,2-dichloro-), CASRN 95-50-1, 
Docket ID number: EPA-HQ-OPPT-2018-0444.
    5. p-Dichlorobenzene (Benzene, 1,4-dichloro-), CASRN 106-46-7, 
Docket ID number: EPA-HQ-OPPT-2018-0446.
    6. 1,1-Dichloroethane, CASRN 75-34-3, Docket ID number: EPA-HQ-
OPPT-2018-0426.
    7. 1,2-Dichloroethane, CASRN 107-06-2, Docket ID number: EPA-HQ-
OPPT-2018-0427.
    8. trans-1,2-Dichloroethylene (Ethene, 1,2-dichloro-, (1E)-), 
CASRN 156-60-5, Docket ID number: EPA-HQ-OPPT-2018-0465.
    9. 1,2-Dichloropropane, CASRN 78-87-5, Docket ID number: EPA-HQ-
OPPT-2018-0428.
    10. Dicyclohexyl phthalate (1,2-Benzenedicarboxylic acid, 1,2-
dicyclohexyl ester), CASRN 84-61-7, Docket ID number: EPA-HQ-OPPT-
2018-0504.
    11. Di-ethylhexyl phthalate (DEHP) (1,2-Benzenedicarboxylic 
acid, 1,2-bis(2-ethylhexyl) ester), CASRN 117-81-7, Docket ID 
number: EPA-HQ-OPPT-2018-0433.
    12. Di-isobutyl phthalate (DIBP) (1,2-Benzenedicarboxylic acid, 
1,2-bis(2-methylpropyl) ester), CASRN 84-69-5, Docket ID number: 
EPA-HQ-OPPT-2018-0434.
    13. Ethylene dibromide (Ethane, 1,2-dibromo-), CASRN 106-93-4, 
Docket ID number: EPA-HQ-OPPT-2018-0488.
    14. Formaldehyde, CASRN 50-00-0, Docket ID number: EPA-HQ-OPPT-
2018-0438.
    15. 1,3,4,6,7,8-Hexahydro-4,6,6,7,8,8-hexamethylcyclopenta [g]-
2-benzopyran (HHCB), CASRN 1222-05-5, Docket ID number: EPA-HQ-OPPT-
2018-0430.
    16. 4,4'-(1-Methylethylidene)bis[2, 6-dibromophenol] (TBBPA), 
CASRN 79-94-7, Docket ID number: EPA-HQ-OPPT-2018-0462.
    17. Phosphoric acid, triphenyl ester (TPP) CASRN 115-86-6, 
Docket ID number: EPA-HQ-OPPT-2018-0458.
    18. Phthalic anhydride (1,3-Isobenzofurandione), CASRN 85-44-9, 
Docket ID number: EPA-HQ-OPPT-2018-0459.
    19. 1,1,2-Trichloroethane, CASRN 79-00-5, Docket ID number: EPA-
HQ-OPPT-2018-0421.
    20. Tris(2-chloroethyl) phosphate (TCEP) (Ethanol, 2-chloro-, 
1,1',1''-phosphate), CASRN 115-96-8, Docket ID number: EPA-HQ-OPPT-
2018-0476.

V. References

    The following is a listing of the documents that are specifically 
referenced in this document. The docket includes these documents and 
other information considered by EPA, including documents that are 
referenced within the documents that are included in the docket, even 
if the referenced document is not physically located in the docket. For 
assistance in locating these other documents, please consult the 
technical person listed under FOR FURTHER INFORMATION CONTACT.

1. EPA. Initiation of Prioritization Under the Toxic Substances 
Control Act (TSCA). Notice. Federal Register. (84 FR 10491, March 
21, 2019) (FRL-9991-06).

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

    Dated: August 16, 2019.
Andrew R. Wheeler,
Administrator.
[FR Doc. 2019-18134 Filed 8-22-19; 8:45 am]
 BILLING CODE 6560-50-P