[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