Initiation of Prioritization Under the Toxic Substances Control Act (TSCA)
| Published date | 21 March 2019 |
| Citation | 84 FR 10491 |
| Record Number | 2019-05404 |
| Section | Notices |
| Court | Environmental Protection Agency |
Federal Register, Volume 84 Issue 55 (Thursday, March 21, 2019)
[Federal Register Volume 84, Number 55 (Thursday, March 21, 2019)]
[Notices]
[Pages 10491-10498]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-05404]
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ENVIRONMENTAL PROTECTION AGENCY
[EPA-HQ-OPPT-2019-0131; FRL-9991-06]
Initiation of Prioritization Under the Toxic Substances Control
Act (TSCA)
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice.
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SUMMARY: As required under the Toxic Substances Control Act (TSCA) and
related implementing regulations, EPA is initiating the prioritization
process for 20 chemical substances as candidates for designation as
High Priority Substances for risk evaluation and 20 chemical substances
as candidates for designation as Low Priority Substances for risk
evaluation. This document provides the identity of the chemical
substances being initiated for prioritization, a general explanation of
why the Agency chose these chemical substances and information on the
data sources that EPA plans to use to support the designation. EPA is
providing a 90-day comment period during which interested persons may
submit relevant information on these chemical substances.
DATES: Comments must be received on or before June 19, 2019.
ADDRESSES: Use one of the following methods to submit comments,
directing not related to a specific chemical, including comments on
Unit V., to docket identification (ID) number EPA-HQ-OPPT-2019-0131;
submit information on the 20 candidates for which EPA is initiating the
prioritization process before designation as High Priority Substances
for risk evaluation to the applicable chemical specific docket ID
number identified in Unit III.B.; and submit information on the 20
candidates for which EPA is initiating the prioritization process
before designation as Low Priority Substances for risk evaluation to
the applicable chemical specific docket ID number 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
candidates for high priority 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 technical information about the candidates for low priority
contact: Lauren Sweet, Chemistry, Economics and Sustainable Strategies
Division, Office of Pollution Prevention and Toxics, Office of Chemical
Safety and Pollution Prevention, Environmental Protection Agency
(Mailcode 7406M) 1200 Pennsylvania Ave. NW, Washington, DC 20460-0001;
telephone number: (202) 564-0376; 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].
SUPPLEMENTARY INFORMATION:
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, users, non-profit
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 initiating the prioritization process under the Toxic
Substances Control Act (TSCA), 15 U.S.C. 2601 et
[[Page 10492]]
seq., for 20 chemical substances as candidates for designation as High
Priority Substances for risk evaluation and 20 chemical substances as
candidates for designation as Low Priority Substances for risk
evaluation. This document includes the identity of the chemical
substances entering the prioritization process before designation, and
a general explanation of why the Agency chose to initiate
prioritization on these chemical substances. In addition, EPA is
providing a 90-day comment period during which interested persons may
submit relevant information on these chemical substances. Relevant
information might include, but is not limited to, any information that
may inform the prioritization screening review conducted pursuant to 40
CFR 702.9(a).
C. Why is the Agency taking this action?
TSCA section 6(b) requires that EPA initiate the prioritization
process for chemical substances that may be designated as high priority
and low priority for risk evaluation. Per TSCA section 6(b)(2)(B), EPA
must designate at least 20 low priority substances and 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).
The request for interested persons to submit relevant information on a
chemical substance for which EPA has initiated the prioritization
process is required by TSCA section 6(b)(1)(C)(i).
D. What is the Agency's authority for taking this action?
This document is issued pursuant to the authority in TSCA section
6(b)(1).
E. What are the estimated incremental impacts of this action?
This document identifies the 40 chemical substances for which EPA
is initiating the prioritization process, provides a general
explanation of why the Agency chose to initiate prioritization on these
chemical substances, and provides a 90-day comment period for
interested persons to submit relevant information. 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 information 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), as amended by the Frank R. Lautenberg
Chemical Safety for the 21st Century Act (Pub. L. 114-182), requires
EPA to prioritize chemical substances for risk evaluation and to
establish a process for prioritizing chemical substances. As required
by TSCA section 6(b) and described in 40 CFR 702.7, EPA is initiating
the prioritization process for 20 chemical substances as candidates for
High Priority Substances for risk evaluation and 20 chemical substances
as candidates for designation as Low Priority Substances.
Under the amended statute (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 Low Priority Substance is described as
a chemical that EPA concludes, based on information sufficient to
establish, without consideration of costs or other non-risk factors,
does not meet the statutory criteria for designation as a High Priority
Substance.
Initiation of prioritization for substances as High Priority
candidates is not a finding of risk. Rather, when prioritization is
complete, for those chemicals designated as high, the Agency will have
evidence that this substance 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 under the
conditions of use. A final designation of a Low Priority substance does
not require a finding of low or no risk; rather, it is sufficient to
show that the chemical does not meet the statutory criteria for a High
Priority substance and that risk evaluation is not warranted at this
time (40 CFR 702.15).
This document is intended to fulfill the TSCA section 6(b)(1)(C)(i)
requirement that the Administrator request interested persons to submit
relevant information on chemical substances that the Administrator has
identified as candidates for designation as High Priority and Low
Priority Substances for risk evaluation. As described in 40 CFR 702.7,
this document also initiates the prioritization process, and provides
90 days during which interested persons may submit relevant
information.
As described in 40 CFR 702.9(b) Information sources, in conducting
the screening review during the prioritization process, EPA will
consider sources of information relevant to the screening 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).
Consistent with the approach in our A Working Approach for
Identifying Potential Candidate Chemicals for Prioritization (September
27, 2018) and prioritization process (40 CFR 702.7), EPA consulted with
other federal agencies and intends to continue to collaborate with them
to identify information that is useful throughout the prioritization
process.
[[Page 10493]]
III. High Priority Candidate Chemical Substances for Which EPA Is
Initiating Prioritization
A. Candidates for Which EPA Is Initiating Prioritization for
Designation as High Priority Substances for Risk Evaluation
EPA's working approach to selecting candidates for designation as
High Priority Substances for risk evaluation is outlined in the
document, A Working Approach for Identifying Potential Candidate
Chemicals for Prioritization, released to the public on September 27,
2018 (https://www.epa.gov/sites/production/files/2018-09/documents/preprioritization_white_paper_9272018.pdf). To identify candidates for
designation as High Priority Substances the Agency primarily looked to
the TSCA Work Plan for Chemical Assessments: 2014 Update (2014 TSCA
Work Plan). EPA surveyed the information and checked quality data
elements in a step-wise approach that ensured responsible and timely
completion of the process according to TSCA timelines. Additionally,
EPA opened dockets for each of the 2014 TSCA Work Plan chemicals, and
an additional docket for non-2014 TSCA Work Plan chemicals, to allow
for public comment on the prioritization of these chemicals.
The sources of information, as described in the document A Working
Approach for Identifying Potential Candidate Chemicals for
Prioritization, included:
1. Type 1 sources: Existing databases (and dashboards) that allow
the user to sift through information using a graphical user-interface,
a direct query such as Structured Query Language (SQL), or webservice
Application Programming Interface (APIs). EPA's National Center for
Computational Toxicology's Chemistry Dashboard (Chemistry Dashboard)
(https://comptox.epa.gov/dashboard) is one of the several examples of a
Type 1 source.
2. Type 2 sources: Additional details from existing information
from public and non-public (i.e., confidential business information)
sources that are maintained by competent authorities--this includes
supporting information from other EPA program offices, state and
federal agencies including assessments or evaluations from various U.S.
and international organizations (e.g., including but not limited to
EPA's Integrated Risk Information System (IRIS) Assessments, EPA's
Office of Water, EPA's Office of Air and Radiation, EPA's High
Production Volume Challenge Program, International Agency for Research
on Cancer (IARC), National Toxicology Program (NTP), National Institute
for Occupational Safety and Health (NIOSH), Organisation for Economic
Co-operation and Development (OECD), Agency for Toxic Substances and
Disease Registry (ATSDR), and California Environmental Protection
Agency (Cal EPA)).
3. Type 3 sources: Initial searches of additional sources of
information within the public and gray literature domains that are not
available from Type 1 and 2 sources (e.g., searches in PubMed, ToxNet,
other U.S. government and international websites).
After identifying evidence of information from reasonably available
sources, the information was evaluated across several data elements
including hazard, exposure, uses, and physicochemical, fate and
transport properties.
After reviewing the three types of data, as explained previously,
the chemical substances were reviewed for data availability across all
data elements (e.g., hazard, exposure, uses, and physicochemical, fate
and transport properties). Considerations were given for chemical
similarity, similar identified functions (e.g., solvents, phthalates,
flame retardants), existing OPPT work (e.g., experience gained from the
first ten chemicals to undergo risk evaluation) and other information
as identified in available risk assessments (e.g., IRIS, ECHA), and
public literature.
In the absence of measured data on chemicals being evaluated, EPA
may use alternative means or new approach methods (NAMs) to obtain
relevant data. These NAMs can reduce vertebrate testing, consistent
with TSCA section 4(h)(1)(A). EPA intends to use this approach to the
extent practicable and scientifically justified.
To identify chemical substances, EPA considered information such as
the 2016 CDR reported uses and products as a surrogate for complexity
of information to inform prioritization and risk evaluation. EPA
considered the release and use information for these chemicals and
screened them according to the types of industrial uses and types of
products where the chemicals were used, as reported in the 2016 CDR.
EPA considers a chemical with fewer unique uses as a lower work load
and a chemical with multiple uses reported as a higher work load.
EPA intends to update and refine its initial review based on data
sources identified by the public during the comment period (see EPA's
request for data in Unit V.) and, where permitted by TSCA section 14
and subject to EPA confidentiality regulations at 40 CFR part 2,
subpart B, intends to make this information publicly available for the
20 initiated chemicals when we publish the proposed priority
designation.
B. Chemicals Initiated
EPA is initiating the prioritization process for the following
twenty chemicals as candidates for designation as High Priority
Substance candidates.
1. 1,3-Butadiene, CAS RN 106-99-0, Docket number: EPA-HQ-OPPT-2018-
0451. This chemical was listed in the 2014 Work Plan Chemicals with a
hazard score of 3; an exposure score of 3; and a persistence and
bioaccumulation score of 1. Data regarding the use of this chemical was
reported to EPA in 2016. EPA also receives information annually on this
chemical through the Toxics Release Inventory. Information is available
from assessments by another federal agency and by other countries.
2. Butyl benzyl phthalate (BBP) (1,2-Benzenedicarboxylic acid, 1-
butyl 2-(phenylmethyl) ester), CAS RN 85-68-7, Docket number: EPA-HQ-
OPPT-2018-0501. This phthalate ester was listed in the 2014 Work Plan
Chemicals with a hazard score of 3; an exposure score of 3; and a
persistence and bioaccumulation score of 1. Data regarding the use of
this chemical was reported to EPA in 2016. EPA also receives
information annually on this chemical through the Toxics Release
Inventory. Information is available from assessments by other
countries.
3. Dibutyl phthalate (DBP) (1,2-Benzenedicarboxylic acid, 1,2-
dibutyl ester), CAS RN 84-74-2, Docket number: EPA-HQ-OPPT-2018-0503.
This phthalate ester was listed in the 2014 Work Plan Chemicals with a
hazard score of 3; an exposure score of 3; and a persistence and
bioaccumulation score of 1. Data regarding the use of this chemical was
reported to EPA in 2016. EPA also receives information annually on this
chemical through the Toxics Release Inventory. Information is available
from assessments by another federal agency and by other countries.
4. 1,1-Dichloroethane, CAS RN 75-34-3, Docket number: EPA-HQ-OPPT-
2018-0426. This chlorinated solvent was listed in the 2014 Work Plan
Chemicals with a hazard score of 2; an exposure score of 3; and a
persistence and bioaccumulation score of 2. Data regarding the use of
this chemical was reported to EPA in 2016. EPA also receives
information on this chemical through the Toxics Release Inventory.
Information is available from assessments by another federal agency.
[[Page 10494]]
5. 1,2-Dichloroethane, CAS RN 107-06-2, Docket number: EPA-HQ-OPPT-
2018-0427. This chlorinated solvent was listed in the 2014 Work Plan
Chemicals with a hazard score of 3; an exposure score of 3; and a
persistence and bioaccumulation score of 2. Data regarding the use of
this chemical was reported to EPA in 2016. EPA also receives
information annually on this chemical through the Toxics Release
Inventory. Information is available from assessments conducted by
another federal agency and another country.
6. 1,2-Dichloropropane, CAS RN 78-87-5, Docket number: EPA-HQ-OPPT-
2018-0428. This chlorinated solvent was listed in the 2014 Work Plan
Chemicals with a hazard score of 2; an exposure score of 3; and a
persistence and bioaccumulation score of 2. Data regarding the use of
this chemical was reported to EPA in 2016. EPA also receives
information annually on this chemical through the Toxics Release
Inventory. This chemical is also subject to other EPA regulations. In
addition, information is available from assessments by another federal
agency.
7. Dicyclohexyl phthalate (1,2-Benzenedicarboxylic acid, 1,2-
dicyclohexyl ester), CAS RN 84-61-7, Docket number: EPA-HQ-OPPT-2018-
0504. This phthalate ester was listed in the 2014 Work Plan Chemicals
with a hazard score of 3 (based solely on environmental toxicity); an
exposure score of 3; and a persistence and bioaccumulation score of 1.
Data regarding the use of this chemical was reported to EPA in 2016.
Information is available from assessment by another country.
8. Di-ethylhexyl phthalate (DEHP) (1,2-Benzenedicarboxylic acid,
1,2-bis(2-ethylhexyl) ester), CAS RN 117-81-7, Docket number: EPA-HQ-
OPPT-2018-0433. This phthalate ester was listed in the 2014 Work Plan
Chemicals with a hazard score of 3; an exposure score of 3; and a
persistence and bioaccumulation score of 1. Data regarding the use of
this chemical was reported to EPA in 2016. EPA also receives
information annually on this chemical through the Toxics Release
Inventory. Information is available from assessments by another federal
agency and by other countries.
9. Di-isobutyl phthalate (DIBP) (1,2-Benzenedicarboxylic acid, 1,2-
bis(2-methylpropyl) ester), CAS RN 84-69-5, Docket number: EPA-HQ-OPPT-
2018-0434. This phthalate ester was listed in the 2014 Work Plan
Chemicals with a hazard score of 1; an exposure score of 2; and a
persistence and bioaccumulation score of 1. Data regarding the use of
this chemical was reported to EPA in 2016. Information is available
from assessments by other countries.
10. Ethylene dibromide (Ethane, 1,2-dibromo-), CAS RN 106-93-4,
Docket number: EPA-HQ-OPPT-2018-0488. This chemical was listed in the
2014 Work Plan Chemicals with a hazard score of 3; an exposure score of
2; and a persistence and bioaccumulation score of 2. Data regarding the
use of this chemical was reported to EPA in 2016. EPA also receives
information annually on this chemical through the Toxics Release
Inventory. EPA released a screening-level hazard characterization in
2009. In addition, information is available from assessments by another
federal agency.
11. Formaldehyde, CAS RN 50-00-0, Docket number: EPA-HQ-OPPT-2018-
0438. This chemical was listed in the 2014 Work Plan Chemicals with a
hazard score of 3; an exposure score of 3; and a persistence and
bioaccumulation score of 1. Data regarding the use of this chemical was
reported to EPA in 2016. EPA also receives information on this chemical
annually through the Toxics Release Inventory. EPA published the
Formaldehyde Emission Standards for Composite Wood Products final rule
in 2016. Information is available from assessments by another federal
agency and other countries.
12. 1,3,4,6,7,8-Hexahydro-4,6,6,7,8,8-hexamethylcyclopenta [g]-2-
benzopyran (HHCB), CAS RN 1222-05-5, Docket number: EPA-HQ-OPPT-2018-
0430. This chemical was listed in the 2014 Work Plan Chemicals with a
hazard score of 2; an exposure score of 3; and a persistence and
bioaccumulation score of 2. Data regarding the use of this chemical was
reported to EPA in 2016. This chemical is also subject to other EPA
regulations. EPA completed a risk assessment of the ecological risks
from HHCB as fragrance ingredient in commercial and consumer products
in 2014. EPA released a screening-level hazard characterization in
2008. In addition, information is available from assessment by another
country.
13. 4,4'-(1-Methylethylidene)bis[2, 6-dibromophenol] (TBBPA), CAS
RN 79-94-7, Docket number: EPA-HQ-OPPT-2018-0462. This halogenated
flame retardant was listed in the 2014 Work Plan Chemicals with a
hazard score of 2 (based solely on environmental toxicity); an exposure
score of 3; and a persistence and bioaccumulation score of 2. Data
regarding the use of this chemical was reported to EPA in 2016. EPA
also receives information annually on this chemical through the Toxics
Release Inventory. EPA released a problem formulation for TBBPA in
2015. Information is available from assessment by another country.
14. o-Dichlorobenzene (Benzene, 1,2-dichloro-), CAS RN 95-50-1,
Docket number: EPA-HQ-OPPT-2018-0444. This chlorinated solvent was
listed in the 2014 Work Plan Chemicals with a hazard score of 2; an
exposure score of 3; and a persistence and bioaccumulation score of 2.
Data regarding the use of this chemical was reported to EPA in 2016.
EPA also receives information on this chemical through the Toxics
Release Inventory. EPA completed a screening-level hazard
characterization of this chemical in 2009. Information is available
from assessments by another federal agency and other countries.
15. p-Dichlorobenzene (Benzene, 1,4-dichloro-), CAS RN 106-46-7,
Docket number: EPA-HQ-OPPT-2018-0446. This chlorinated solvent was
listed in the 2014 Work Plan Chemicals with a hazard score of 3; an
exposure score of 3; and a persistence and bioaccumulation score of 2.
Data regarding the use of this chemical was reported to EPA in 2016.
EPA also receives information annually on this chemical through the
Toxics Release Inventory. EPA identified information available from
assessments by another federal agency and other countries.
16. Phosphoric acid, triphenyl ester (TPP), CAS RN 115-86-6, Docket
number: EPA-HQ-OPPT-2018-0458. This halogenated flame retardant was
listed in the 2014 Work Plan Chemicals with a hazard score of 3 (based
solely on environmental toxicity); an exposure score of 3; and a
persistence and bioaccumulation score of 2. Data regarding the use of
this chemical was reported to EPA in 2016.
17. Phthalic anhydride (1,3-Isobenzofurandione), CAS RN 85-44-9,
Docket number: EPA-HQ-OPPT-2018-0459. This chemical was listed in the
2014 Work Plan Chemicals with a hazard score of 3; an exposure score of
3; and a persistence and bioaccumulation score of 1. Data regarding the
use of this chemical was reported to EPA in 2016. EPA also received
receives information on this chemical annually through the Toxics
Release Inventory.
18. trans-1,2- Dichloroethylene (Ethene, 1,2-dichloro-, (1E)-), CAS
RN 156-60-5, Docket number: EPA-HQ-OPPT-2018-0465. This chlorinated
solvent was listed in the 2014 Work Plan Chemicals with a hazard score
of 2; an exposure score of 3; and a persistence and bioaccumulation
score of 2. Data regarding the use of this chemical was reported to EPA
in 2016.
[[Page 10495]]
EPA completed a screening-level hazard characterization of this
chemical in 2015.
19. 1,1,2-Trichloroethane, CAS RN 79-00-5, Docket number: EPA-HQ-
OPPT-2018-0421. This chlorinated solvent was listed in the 2014 Work
Plan Chemicals with a hazard score of 3; an exposure score of 2; and a
persistence and bioaccumulation score of 2. Data regarding the use of
this chemical was reported to EPA in 2016. EPA also receives
information annually on this chemical through the Toxics Release
Inventory. Information is available from assessments by another federal
agency.
20. Tris(2-chloroethyl) phosphate (TCEP) (Ethanol, 2-chloro-,
1,1',1''-phosphate), CAS RN 115-96-8, Docket number: EPA-HQ-OPPT-2018-
0476. This halogenated flame retardant was listed in the 2014 Work Plan
Chemicals with a hazard score of 2; an exposure score of 2; and a
persistence and bioaccumulation score of 2. Data regarding the use of
this chemical was reported to EPA in 2016. EPA released a problem
formulation for TCEP in 2015. Information is available from assessment
by another country.
IV. Low Priority Candidate Chemical Substances for Which EPA Is
Initiating Prioritization
A. Candidates for Which EPA Is Initiating Prioritization for
Designation as Low Priority Substances for Risk Evaluation
1. EPA's working approach to selecting candidates for designation
as Low Priority Substances for risk evaluation is outlined in the
document, A Working Approach for Identifying Potential Candidate
Chemicals for Prioritization, released to the public on September 27,
2018 (https://www.epa.gov/sites/production/files/2018-09/documents/preprioritization_white_paper_9272018.pdf ).As elaborated in this unit,
EPA has taken steps to implement the approach outlined in the working
approach document.
Starting with over 30,000 chemicals from the April 2018 interim
update of the TSCA active inventory, EPA applied a series of filtering
steps to identify potential Low Priority Substance candidates. EPA's
goal was to select chemicals that are among the best-suited for
possible Low Priority Substance designation. EPA identified potential
Low Priority Substance candidates based on low-hazard, across a range
of endpoints, as the initial criterion since EPA knew the data on
hazard would be the most readily available.
EPA first narrowed the candidate pool to chemicals that had been
evaluated by a government body like the U.S. EPA or an OECD member
nation. EPA's Safer Chemicals Ingredients List (SCIL) and Chemical
Assessment Management Program (ChAMP), as well as the OECD Screening
Information Data Sets, served as sources of government-evaluated
chemicals. The SCIL (https://www.epa.gov/saferchoice/safer-ingredients)
is a continuously updated list of chemicals that meet low-concern Safer
Choice criteria (https://www.epa.gov/saferchoice/standard) for both
human health and ecological endpoints. Based on assessments used to
support their listing on the SCIL, EPA has found these chemicals to be
relatively rich in data on hazard. Under ChAMP, EPA scientists
performed interim evaluations of hazard, use, and exposure of high- and
medium-production volume chemicals. These screening-level risk
characterizations were interim evaluations that constituted neither a
final Agency determination on risk nor a determination as to whether
sufficient data were available to characterize risk. Screening
Information Dataset (SIDS) Initial Assessment Reports (SIARs) (https://hpvchemicals.oecd.org/ui/Default.aspx), prepared by OECD member
nations, represent a systematic investigation of the potential risks to
human health and the environment, and are most often associated with
high-production-volume (HPV) chemicals. SIARs include a base set of
hazard information, known as the SIDS elements, for each chemical
substance and incorporate available information on use patterns and
exposure to put hazard(s) into context (http://www.oecd.org/chemicalsafety/risk-assessment/1947541.pdf). Through public meetings
and comments, EPA stakeholders indicated support for use of SCIL, ChAMP
evaluations on chemicals of low concern, and relevant SIDS assessments
as a starting point for identifying Low Priority Substance candidates.
2. As a next filtering step and to increase confidence in the
information on hazard, conditions of use and exposure, EPA filtered the
pool of approximately 1,600 chemicals to approximately 200 substances
having discretely defined structures. Data on chemicals with discrete
structures, as opposed to those with variable structures, are more
reliable and easily compared because of the certainty a definitive
molecular structure provides in assessing hazard, conditions of use,
and exposure. EPA further filtered the chemicals with discrete
structures and selected those with the most available data, narrowing
the pool to about 75 chemicals with low-hazard status among an
internationally accepted set of endpoints. EPA applied a final screen
by conducting a literature search to update and verify candidate
information for reliability, completeness and consistency. With a set
of high-quality data relevant to a potential designation as a Low
Priority Substance, EPA reduced the candidate pool to the 20 chemical
substances being initiated today. EPA will make transparent literature
search documentation available at the proposal phase for the 20 Low
Priority Substance candidates. EPA intends to update and refine its
initial review based on data sources identified by the public during
the comment period (see EPA's request for data in Unit V.) and, where
permitted by TSCA section 14 and subject to EPA confidentiality
regulations at 40 CFR part 2, subpart B, intends to make this
information publicly available for the 20 initiated chemicals at
proposal. This unit contains information on the data sources EPA is
using to obtain reasonably available information for evaluating
candidate Low Priority Substances consistent with TSCA section
6(b)(1)(B) and implementing regulations. EPA encourages submission of
additional information relevant to Low Priority Substance designation
that stakeholders believe may not be found in the sources listed.
a. Data sources. EPA intends to search for and review literature
from primary literature databases and gray literature and additional
search strategies.
b. NAMs and Analogous chemical data. In the absence of measured
data on chemicals being evaluated, EPA may use alternative means or new
approach methods (NAMs) to obtain relevant data. These NAMs can reduce
vertebrate testing, consistent with TSCA section 4(h)(1)(A). EPA
intends to use this approach to the extent practicable and
scientifically justified.
EPA will consider closely related, analogous chemicals, or analogs,
and use data from these chemicals to demonstrate the suitability of a
chemical for proposal as a Low Priority Substance where appropriate.
The use of appropriate analogs in chemical assessment is a
scientifically valid, widely adopted practice. Governments worldwide
use analogs to fill data gaps in both regulatory and prioritization
contexts. Examples can be found in the OECD screening information
dataset (SIDS), the EU Registration, Evaluation, Authorisation and
Restriction of Chemicals (REACH), the Canadian
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Chemicals Management Plan (CMP), and the Australian National Industrial
Chemicals Notification and Assessment Scheme (NICNAS).
Suitable analogs will be chosen based on chemical biological
similarities (e.g., chemical structure, metabolic breakdown or likely
mechanistic/mode of action considerations). Information on the value of
analogs and guidance for identifying suitable analogs can be found in
OECD Series on Testing and Assessment No. 194 Guidance on Grouping of
Chemicals, Second Edition (2014). EPA will use expert judgment to
determine if the analog or model used is appropriate for the attribute
being evaluated. EPA will consider each case separately, make the
analog we have selected and the data we are using from it transparent,
and accept public comment on alternative approaches.
EPA will also consider modeled data from sources such as ECOSAR,
Oncologic, EPI Suite, and other models when determined to be within the
domain of applicability or supported by analog data.
B. Chemicals Initiated
EPA is initiating the prioritization process for the following
twenty chemicals as candidates for designation as Low Priority
Substance candidates.
1. 1-Butanol, 3-methoxy-, 1-acetate (CAS RN 4435-53-4), Docket ID
number: EPA-HQ-OPPT-2019-0106. EPA has selected 1-butanol, 3- methoxy-,
1-acetate for initiation as a candidate for potential designation as a
low priority substance because it has a comprehensive data set
demonstrating lower hazard, based on an internationally accepted set of
low-concern thresholds for a broad range of endpoints, and in view of
its known, intended and reasonably foreseen uses. Given the low-hazard
profile, EPA does not expect estimated exposures to alter the
assessment supporting its initiation as a candidate for potential
designation as a low priority substance.
2. D-gluco-Heptonic acid, sodium salt (1:1), (2.xi.)- (CAS RN
31138-65-5), Docket ID number: EPA-HQ-OPPT-2019-0107. EPA has selected
d-gluco-heptonic acid, sodium salt (1:1), (2.xi.)- for initiation as a
candidate for potential designation as a low priority substance because
it has a comprehensive data set demonstrating lower hazard, based on an
internationally accepted set of low-concern thresholds for a broad
range of endpoints, and in view of its known, intended and reasonably
foreseen uses. Given the low-hazard profile, EPA does not expect
estimated exposures to alter the assessment supporting its initiation
as a candidate for potential designation as a low priority substance.
3. D-Gluconic acid (CAS RN 526-95-4), Docket ID number: EPA-HQ-
OPPT-2019-0108. EPA has selected d-gluconic acid for initiation as a
candidate for potential designation as a low priority substance because
it has a comprehensive data set demonstrating lower hazard, based on an
internationally accepted set of low-concern thresholds for a broad
range of endpoints, and in view of its known, intended and reasonably
foreseen uses. Given the low-hazard profile, EPA does not expect
estimated exposures to alter the assessment supporting its initiation
as a candidate for potential designation as a low priority substance.
While EPA will present an independent review if this chemical is
proposed as a Low Priority Substance, EPA notes that this chemical has
been evaluated and determined to be ``low priority for further work''
for human health and the environment in the OECD SIDS Initial
Assessment Report (April 2004).
4. D-Gluconic acid, calcium salt (2:1) (CAS RN 299-28-5), Docket ID
number: EPA-HQ-OPPT-2019-0109. EPA has selected d-gluconic acid,
calcium salt (2:1) for initiation as a candidate for potential
designation as a low priority substance because it has a comprehensive
data set demonstrating lower hazard, based on an internationally
accepted set of low-concern thresholds for a broad range of endpoints,
and in view of its known, intended and reasonably foreseen uses. Given
the low-hazard profile, EPA does not expect estimated exposures to
alter the assessment supporting its initiation as a candidate for
potential designation as a low priority substance. While EPA will
present an independent review if this chemical is proposed as a Low
Priority Substance, EPA notes that this chemical has been evaluated and
determined to be ``low priority for further work'' for human health and
the environment in the OECD SIDS Initial Assessment Report (April
2004).
5. D-Gluconic acid, .delta.-lactone (CAS RN 90-80-2), Docket ID
number: EPA-HQ-OPPT-2019-0110. EPA has selected d-gluconic acid,
.delta.-lactone for initiation as a candidate for potential designation
as a low-priority substance because it has a comprehensive data set
demonstrating lower hazard, based on an internationally accepted set of
low-concern thresholds for a broad range of endpoints, and in view of
its known, intended and reasonably foreseen uses. Given the low-hazard
profile, EPA does not expect estimated exposures to alter the
assessment supporting its initiation as a candidate for potential
designation as a low priority substance. While EPA will present an
independent review if this chemical is proposed as a Low Priority
Substance, EPA notes that this chemical has been evaluated and
determined to be ``low priority for further work'' for human health and
the environment in the OECD SIDS Initial Assessment Report (April
2004).
6. D-Gluconic acid, potassium salt (1:1) (CAS RN 299-27-4), Docket
ID number: EPA-HQ-OPPT-2019-0111. EPA has selected d-gluconic acid,
potassium salt (1:1) for initiation as a candidate for potential
designation as a low priority substance because it has a comprehensive
data set demonstrating lower hazard, based on an internationally
accepted set of low-concern thresholds for a broad range of endpoints,
and in view of its known, intended and reasonably foreseen uses. Given
the low-hazard profile, EPA does not expect estimated exposures to
alter the assessment supporting its initiation as a candidate for
potential designation as a low priority substance. While EPA will
present an independent review if this chemical is proposed as a Low
Priority Substance, EPA notes that this chemical has been evaluated and
determined to be ``low priority for further work'' for human health and
the environment in the OECD SIDS Initial Assessment Report (April
2004).
7. D-Gluconic acid, sodium salt (1:1) (CAS RN 527-07-1), Docket ID
number: EPA-HQ-OPPT-2019-0112. EPA has selected d-gluconic acid, sodium
salt (1:1) for initiation as a candidate for potential designation as a
low priority substance because it has a comprehensive data set
demonstrating lower hazard, based on an internationally accepted set of
low-concern thresholds for a broad range of endpoints, and in view of
its known, intended and reasonably foreseen uses. Given the low-hazard
profile, EPA does not expect estimated exposures to alter the
assessment supporting its initiation as a candidate for potential
designation as a low priority substance. While EPA will present an
independent review if this chemical is proposed as a Low Priority
Substance, EPA notes that this chemical has been evaluated and
determined to be ``low priority for further work'' for human health and
the environment in the OECD SIDS Initial Assessment Report (April
2004).
8. Decanedioic acid, 1,10-dibutyl ester (CAS RN 109-43-3), Docket
ID number: EPA-HQ-OPPT-2019-0113. EPA has selected decanedioic acid,
1,10-dibutyl ester for initiation as a candidate for potential
designation as a low priority substance because it has a comprehensive
data set demonstrating
[[Page 10497]]
lower hazard, based on an internationally accepted set of concern
thresholds for a broad range of endpoints, and in view of its known,
intended and reasonably foreseen uses. Given the low-hazard profile,
EPA does not expect estimated exposures to alter the assessment
supporting its initiation as a candidate for potential designation as a
low priority substance.
9. 1-Docosanol (CAS RN 661-19-8), Docket ID number: EPA-HQ-OPPT-
2019-0114. EPA has selected 1-docosanol for initiation as a candidate
for potential designation as a low-priority substance because it has a
comprehensive data set demonstrating lower hazard, based on an
internationally accepted set of low-concern thresholds for a broad
range of endpoints, and in view of its known, intended and reasonably
foreseen uses. Given the low-hazard profile, EPA does not expect
estimated exposures to alter the assessment supporting its initiation
as a candidate for potential designation as a low priority substance.
While EPA will present an independent review if this chemical is
proposed as a Low Priority Substance, EPA notes that this chemical has
been evaluated and determined to be ``low priority for further work''
for human health and the environment in the OECD SIDS Initial
Assessment Report (April 2006). 1-docosanol was also evaluated by EPA's
ChAMP program.
10. 1-Eicosanol (CAS RN 629-96-9), Docket ID number: EPA-HQ-OPPT-
2019-0115. EPA has selected 1-eicosanol for initiation as a candidate
for potential designation as a low priority substance because it has a
comprehensive data set demonstrating lower hazard, based on an
internationally accepted set of low-concern thresholds for a broad
range of endpoints, and in view of its known, intended and reasonably
foreseen uses. Given the low-hazard profile, EPA does not expect
estimated exposures to alter the assessment supporting its initiation
as a candidate for potential designation as a low priority substance.
While EPA will present an independent review if this chemical is
proposed as a Low Priority Substance, EPA notes that this chemical has
been evaluated and determined to be ``low priority for further work''
for human health and the environment in the OECD SIDS Initial
Assessment Report (April 2006). 1-eicosanol was also evaluated by EPA's
ChAMP program.
11. 1,2-Hexanediol (CAS RN 6920-22-5), Docket ID number: EPA-HQ-
OPPT-2019-0116. EPA has selected 1,2-hexanediol for initiation as a
candidate for potential designation as a low priority substance because
it has a comprehensive data set demonstrating lower hazard, based on an
internationally accepted set of low-concern thresholds for a broad
range of endpoints, and in view of its known, intended and reasonably
foreseen uses. Given the low-hazard profile, EPA does not expect
estimated exposures to alter the assessment supporting its initiation
as a candidate for potential designation as a low priority substance.
12. 1-Octadecanol (CAS RN 112-92-5), Docket ID number: EPA-HQ-OPPT-
2019-0117. EPA has selected 1-octadecanol for initiation as a candidate
for potential designation as a low priority substance because it has a
comprehensive data set demonstrating lower hazard, based on an
internationally accepted set of low-concern thresholds for a broad
range of endpoints, and in view of its known, intended and reasonably
foreseen uses. Given the low-hazard profile, EPA does not expect
estimated exposures to alter the assessment supporting its initiation
as a candidate for potential designation as a low priority substance.
While an OECD SIDS Initial Assessment Report (August 2002) indicated a
need to examine anaerobic biodegradability and potential long-term fish
toxicity, the follow-on SIDS Initial Assessment Report (April 2006)
concludes, based on new information, that fatty acids with chain
lengths greater than 16, like 1-octadecanol, have low solubility (and
hence low bioavailability), limiting potential chronic toxicity as well
as limiting the need for further research.
13. Propanol, [2-(2-butoxymethylethoxy)methylethoxy]- (CAS RN
55934-93-5), Docket ID number: EPA-HQ-OPPT-2019-0118. EPA has selected
propanol, [2-(2-butoxymethylethoxy)methylethoxy]- for initiation as a
candidate for potential designation as a low priority substance because
it has a comprehensive data set demonstrating lower hazard, based on an
internationally accepted set of low-concern thresholds for a broad
range of endpoints, and in view of its known, intended and reasonably
foreseen uses. Given the low-hazard profile, EPA does not expect
estimated exposures to alter the assessment supporting its initiation
as a candidate for potential designation as a low priority substance.
14. Propanedioic acid, 1,3-diethyl ester (CAS RN 105-53-3), Docket
ID number: EPA-HQ-OPPT-2019-0119. EPA has selected propanedioic acid,
1,3-diethyl ester for initiation as a candidate for potential
designation as a low priority substance because it has a comprehensive
data set demonstrating lower hazard, based on an internationally
accepted set of low-concern thresholds for a broad range of endpoints,
and in view of its known, intended and reasonably foreseen uses. Given
the low-hazard profile, EPA does not expect estimated exposures to
alter the assessment supporting its initiation as a candidate for
potential designation as a low priority substance. While EPA will
present an independent review if this chemical is proposed as a Low
Priority Substance, EPA notes that this chemical has been evaluated and
determined to be ``low priority for further work'' for human health and
the environment in the OECD SIDS Initial Assessment Report (April
2005).
15. Propanedioic acid, 1,3-dimethyl ester (CAS RN 108-59-8), Docket
ID number: EPA-HQ-OPPT-2019-0120. EPA has selected propanedioic acid,
1,3-dimethyl ester for initiation as a candidate for potential
designation as a low priority substance because it has a comprehensive
data set demonstrating lower hazard, based on an internationally
accepted set of low-concern thresholds for a broad range of endpoints,
and in view of its known, intended and reasonably foreseen uses. Given
the low-hazard profile, EPA does not expect estimated exposures to
alter the assessment supporting its initiation as a candidate for
potential designation as a low priority substance. While EPA will
present an independent review if this chemical is proposed as a Low
Priority Substance, EPA notes that this chemical has been evaluated and
determined to be ``low priority for further work'' for human health and
the environment in the OECD SIDS Initial Assessment Report (April
2005).
16. Propanol, 1(or 2)-(2-methoxymethylethoxy)-, acetate (CAS RN
88917-22-0), Docket ID number: EPA-HQ-OPPT-2019-0121. EPA has selected
propanol, 1(or 2)-(2-methoxymethylethoxy)-, acetate for initiation as a
candidate for potential designation as a low priority substance because
it has a comprehensive data set demonstrating lower hazard, based on an
internationally accepted set of low-concern thresholds for a broad
range of endpoints, and in view of its known, intended and reasonably
foreseen uses. Given the low-hazard profile, EPA does not expect
estimated exposures to alter the assessment supporting its initiation
as a candidate for potential designation as a low priority substance.
While EPA will present an independent review if this chemical is
proposed as a Low Priority Substance, EPA notes that this chemical has
been evaluated and determined to be ``low priority for further work''
for human health and the
[[Page 10498]]
environment in the OECD SIDS Initial Assessment Report (November 2003).
17. Propanol, [(1-methyl-1,2-ethanediyl)bis(oxy)]bis- (CAS RN
24800-44-0), Docket ID number: EPA-HQ-OPPT-2019-0122. EPA has selected
propanol, [(1-methyl-1,2-ethanediyl)bis(oxy)]bis- for initiation as a
candidate for potential designation as a low priority substance because
it has a comprehensive data set demonstrating lower hazard, based on an
internationally accepted set of low-concern thresholds for a broad
range of endpoints and in view of its known, intended and reasonably
foreseen uses. Given the low-hazard profile, EPA does not expect
estimated exposures to alter the assessment supporting its initiation
as a candidate for potential designation as a low priority substance.
While EPA will present an independent review if this chemical is
proposed as a Low Priority Substance, EPA notes that this chemical has
been evaluated and determined to be ``low potential risk and low
priority for further work'' in the OECD SIDS Initial Assessment Report
(July 1994).
18. 2-Propanol, 1,1'-oxybis- (CAS RN 110-98-5), Docket ID number:
EPA-HQ-OPPT-2019-0123. EPA has selected 2-propanol, 1,1'-oxybis- for
initiation as a candidate for potential designation as a low priority
substance because it has a comprehensive data set demonstrating lower
hazard, based on an internationally accepted set of low-concern
thresholds for a broad range of endpoints and in view of its known,
intended and reasonably foreseen uses. Given the low-hazard profile,
EPA does not expect estimated exposures to alter the assessment
supporting its initiation as a candidate for potential designation as a
low priority substance. While EPA will present an independent review if
this chemical is proposed as a Low Priority Substance, EPA notes that
this chemical has been evaluated and determined to be ``low priority
for further work'' in the OECD SIDS Initial Assessment Report (January
2001).
19. Propanol, oxybis- (CAS RN 25265-71-8), Docket ID number: EPA-
HQ-OPPT-2019-0124. EPA has selected propanol, oxybis- for initiation as
a candidate for potential designation as a low priority substance
because it has a comprehensive data set demonstrating lower hazard,
based on an internationally accepted set of low-concern thresholds for
a broad range of endpoints and in view of its known, intended and
reasonably foreseen uses. Given the low-hazard profile, EPA does not
expect estimated exposures to alter the assessment supporting its
initiation as a candidate for potential designation as a low priority
substance. While EPA will present an independent review if this
chemical is proposed as a Low Priority Substance, EPA notes that this
chemical has been evaluated and determined to be ``low priority for
further work'' in the OECD SIDS Initial Assessment Report (January
2001).
20. Tetracosane, 2,6,10,15,19,23-hexamethyl- (CAS RN 111-01-3),
Docket ID number: EPA-HQ-OPPT-2019-0125. EPA has selected tetracosane,
2,6,10,15,19,23-hexamethyl- for initiation as a candidate for potential
designation as a low priority substance because it has a comprehensive
data set demonstrating lower hazard, based on an internationally
accepted set of low-concern thresholds for a broad range of endpoints
and in view of its known, intended and reasonably foreseen uses. Given
the low-hazard profile, EPA does not expect estimated exposures to
alter the assessment supporting its initiation as a candidate for
potential designation as a low priority substance.
V. Relevant Information
Through this initiation of prioritization for a chemical substance,
EPA is providing a 90-day comment period as required by the statute
(TSCA section 6(b)(1)(C)(i)) and implementing regulations (40 CFR
702.7(d)), and requests that interested persons voluntarily submit
relevant information. Relevant information might include, but is not
limited to, information that may inform the screening review conducted
pursuant to 40 CFR 702.9(a) and consistent with the scientific standard
of TSCA section 26(h), as follows:
The chemical substance's hazard and exposure potential;
The chemical substance's persistence and bioaccumulation;
Potentially exposed or susceptible subpopulations which
the submitter believes are relevant to the prioritization;
Whether there is any storage of the chemical substance
near significant sources of drinking water, including the storage
facility location and the nearby drinking water source(s);
The chemical substance's conditions of use or significant
changes in conditions of use, including information regarding trade
names;
The chemical substance's production volume or significant
changes in production volume; and
Any other information relevant to the potential risks of
the chemical substance that might be relevant to the designation of the
chemical substance's priority for risk evaluation.
If the information is publicly available, citations are sufficient
(including, but not limited to: Title, author, date of publication,
publication source), and the submission does not need to include copies
of the information.
A person seeking to protect from disclosure as ``confidential
business information'' any information that person submits under TSCA
must assert and substantiate a claim for protection from disclosure
concurrent with submission of the information in accordance with the
requirements of TSCA section 14. While EPA may consider confidential
business information when conducting its review under 40 CFR 702.9(a),
the Agency encourages submitters to minimize claims for protection from
disclosure wherever possible to maximize transparency in EPA's
screening review. More information on asserting and substantiating
confidential business information claims under TSCA can be found at
https://www.epa.gov/tsca-cbi.
Authority: 15 U.S.C. 2601 et seq.
Dated: March 18, 2019.
Andrew R. Wheeler,
Administrator.
[FR Doc. 2019-05404 Filed 3-20-19; 8:45 am]
BILLING CODE 6560-50-P
