Multiple-Path Particle Dosimetry (MPPD) Model Software (MPPD EPA 2021 v.1.01) With Technical Support Documentation and User's Guide (External Review Draft), 15476-15477 [2021-05380]

Download as PDF 15476 Federal Register / Vol. 86, No. 54 / Tuesday, March 23, 2021 / Notices Secretary, Federal Energy Regulatory Commission, 12225 Wilkins Avenue, Rockville, Maryland 20852. The first page of any filing should include docket number P–15094–000. More information about this project, including a copy of the application, can be viewed or printed on the ‘‘eLibrary’’ link of Commission’s website at https:// www.ferc.gov/docs-filing/elibrary.asp. Enter the docket number (P–15094) in the docket number field to access the document. For assistance, contact FERC Online Support. Dated: March 17, 2021. Nathaniel J. Davis, Sr., Deputy Secretary. [FR Doc. 2021–05936 Filed 3–22–21; 8:45 am] BILLING CODE 6717–01–P DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Project No. 6903–036] Battenkill Hydro Associates; Notice of Intent to File License Application, Filing of Pre-Application Document, Approving Use of The Traditional Licensing Process a. Type of Filing: Notice of Intent to File License Application and Request to Use the Traditional Licensing Process. b. Project No.: 6903–036. c. Date Filed: February 1, 2021. d. Submitted By: Battenkill Hydro Associates (Battenkill Hydro). e. Name of Project: Middle Greenwich Hydroelectric Project. f. Location: On the Batten Kill, a tributary of the Hudson River in Washington County, New York. The project does not occupy any federal land. g. Filed Pursuant to: 18 CFR 5.3 of the Commission’s regulations. h. Potential Applicant Contact: Mr. Lewis Loon, General Manager, Operations and Maintenance—USA, Krueger Energy, 423 Brunswick Ave., Gardiner, ME 04345; (207) 203–3027; Lewis.Loon@kruger.com. i. FERC Contact: Andy Bernick at (202) 502–8660; or email at andrew.bernick@ferc.gov. j. Battenkill Hydro filed its request to use the Traditional Licensing Process on February 1, 2021. Battenkill Hydro provided public notice of its request on January 20, 2021. In a letter dated March 17, 2021, the Director of the Division of Hydropower Licensing approved Battenkill Hydro’s request to use the Traditional Licensing Process. k. With this notice, we are initiating informal consultation with the U.S. Fish VerDate Sep<11>2014 17:45 Mar 22, 2021 Jkt 253001 and Wildlife Service and/or NOAA Fisheries under section 7 of the Endangered Species Act and the joint agency regulations thereunder at 50 CFR part 402. We are also initiating consultation with the New York State Historic Preservation Officer, as required by section 106, National Historic Preservation Act, and the implementing regulations of the Advisory Council on Historic Preservation at 36 CFR 800.2. l. With this notice, we are designating Battenkill Hydro as the Commission’s non-federal representative for carrying out informal consultation pursuant to section 7 of the Endangered Species Act and consultation pursuant to section 106 of the National Historic Preservation Act. m. Battenkill Hydro filed a PreApplication Document (PAD; including a proposed process plan and schedule) with the Commission, pursuant to 18 CFR 5.6 of the Commission’s regulations. n. A copy of the PAD may be viewed and/or printed on the Commission’s website (https://www.ferc.gov), using the ‘‘eLibrary’’ link. Enter the docket number, excluding the last three digits in the docket number field, to access the document. At this time, the Commission has suspended access to the Commission’s Public Reference Room, due to the proclamation declaring a National Emergency concerning the Novel Coronavirus Disease (COVID–19), issued by the President on March 13, 2020. For assistance, contact FERC Online Support at FERCOnlineSupport@ferc.gov, (866) 208 3676 (toll free), or (202) 502–8659 (TTY). o. The licensee states its unequivocal intent to submit an application for a subsequent license for Project No. 6903. Pursuant to 18 CFR 16.8, 16.9, and 16.10 each application for a subsequent license and any competing license applications must be filed with the Commission at least 24 months prior to the expiration of the existing license. All applications for license for this project must be filed by April 30, 2024. p. Register online at https:// www.ferc.gov/docs-filing/ esubscription.asp to be notified via email of new filing and issuances related to this or other pending projects. For assistance, contact FERC Online Support. Dated: March 17, 2021. Kimberly D. Bose, Secretary. [FR Doc. 2021–05969 Filed 3–22–21; 8:45 am] BILLING CODE 6717–01–P PO 00000 Frm 00025 Fmt 4703 Sfmt 4703 ENVIRONMENTAL PROTECTION AGENCY [EPA–HQ–ORD–2020–0564; FRL 10020–77– ORD] Multiple-Path Particle Dosimetry (MPPD) Model Software (MPPD EPA 2021 v.1.01) With Technical Support Documentation and User’s Guide (External Review Draft) Environmental Protection Agency (EPA). ACTION: Notice; request for public comment. AGENCY: The Environmental Protection Agency (EPA) is announcing an external expert peer review and public comment for the EPA Multiple-Path Particle Dosimetry (MPPD) Model Software (MPPD EPA 2021 v. 1.01) and its associated ‘‘Technical Support Documentation and User’s Guide (External Review Draft)’’ ([EPA/600/R– 20/406]). The document was prepared by the Center for Public Health and Environmental Assessment (CPHEA) within EPA’s Office of Research and Development (ORD), with contributions from Applied Research Associates, Inc., and Fred J. Miller, LLC. EPA is releasing this draft model software version and associated document to seek review by external experts and the public. This external review draft document and model software (MPPD EPA 2021 v. 1.01) are not final and do not represent, and should not be construed to represent, any final Agency policy or views. When revising the document and the model software, EPA will consider any peer or public comments submitted during the public comment period specified in this document. DATES: The 30-day public comment period begins March 23, 2021 and ends April 22, 2021. Comments must be received on or before April 22, 2021. ADDRESSES: The EPA Multiple-Path Particle Dosimetry (MPPD) Model Software (MPPD EPA 2021 v. 1.01) and its associated ‘‘Technical Support Documentation and User’s Guide’’ (External Review Draft)’’ will be available from the contractor managing the external peer review, Eastern Research Group, Inc. (ERG). To obtain a copy of the external review draft or the associated MPPD software (EPA 2021 v. 1.01), contact ERG at email: peerreview@ erg.com with the Subject line: MPPD EPA 2021 Peer Review; Phone: 781– 674–7362. FOR FURTHER INFORMATION CONTACT: For information on the public comment period, contact the ORD Docket at the EPA Headquarters Docket Center; SUMMARY: E:\FR\FM\23MRN1.SGM 23MRN1 Federal Register / Vol. 86, No. 54 / Tuesday, March 23, 2021 / Notices phone: 202–566–1752; fax: 202–566– 9744; or email: ord.docket@epa.gov. For technical information, contact Annie M. Jarabek; phone: 919–637–6016; or email: jarabek.annie@epa.gov. SUPPLEMENTARY INFORMATION: I. Information About the Document and MPPD Model Software The EPA is undertaking an external peer review of an EPA version of the Multiple-Path Particle Dosimetry (MPPD) model (MPPD EPA 2021 v. 1.01) and its software, together with an EPA Technical Support Documentation and User’s Guide. The EPA introduced formal dosimetry modeling into its derivation procedures for risk assessment of inhaled materials with its 1994 document entitled ‘‘Methods for Derivation of Inhalation Reference Concentrations (RfCs) and Application of Inhalation Dosimetry’’ (US EPA, 1994). These methods relied upon the Regional Deposited Dose Ratio (RDDR) model and underwent two expert technical panel and two expert Science Advisory Board (SAB) reviews prior to finalization. The dosimetry adjustments were also subsequently incorporated into the Agency’s guidelines for carcinogen risk assessment (US EPA, 2005). The EPA RDDR model was an empirical model fit to a unique set of experimental data from inhalation studies across five laboratory animal species commonly used in testing for regulatory risk assessment as well as for humans. The model provided predictions of inhaled deposited dose in various regions of the respiratory tract, including the extrathoracic (ET), tracheobronchial (TB), pulmonary (PU), thoracic (TB + PU) or total respiratory tract (TOTAL). However, since 1994, mechanistic modeling of inhalation dosimetry for particles has matured. The MPPD model and its software include many modernized features, with some dose metric predictions now based on mechanistic descriptions instead of empirical fitting, the ability to address a wider range of particle size, providing prediction of retained mass for some species, and including some different test species. The EPA is convening this external peer review to evaluate the MPPD model. The model results provide dosimetry adjustment of inhalation exposures for the following purposes: Interspecies extrapolation, evaluation of intra-human variability, informing experimental design, and in vitro to in vivo (IVIVE) extrapolation. The EPA Multiple-Path Particle Dosimetry (MPPD) Model Software VerDate Sep<11>2014 17:45 Mar 22, 2021 Jkt 253001 (MPPD EPA 2021 v. 1.01) and its associated ‘‘Technical Support Documentation and User’s Guide (External Review Draft)’’ will be discussed at a virtual external expert peer review meeting, which will be open to the public. In addition to the opportunity to submit written comments during the public comment period announced in this notice, the public will have an opportunity to make brief oral comments during the virtual expert peer panel meeting. For more information about the peer review meeting, including information about how to register, please visit: https:// projects.erg.com/conferences/ peerreview/register-mppd.html. II. How To Submit Technical Comments to the Docket at www.regulations.gov Out of an abundance of caution for members of the public and our staff, the EPA Docket Center and Reading Room are closed to the public, with appointment only, to reduce the risk of transmitting COVID–19. Our Docket Center staff will continue to provide remote customer service via email, phone, and webform. We encourage the public to submit comments via the web at https://www.regulations.gov/ or via email at ord.docket@epa.gov, as there may be a delay in processing mail and faxes. Hand deliveries and couriers may be received by scheduled appointment only. For further information on EPA Docket Center services and the current status, please visit https://www.epa.gov/ dockets. Submit your materials identified by Docket ID No. EPA–HQ–ORD–2020– 0564 by one of the following methods: • www.regulations.gov: Follow the online instructions for submitting comments. • Email: ord.docket@epa.gov. • Fax: 202–566–9744. • Mail: Office of Research and Development (ORD) Docket (Mail Code: 28221T), U.S. Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460. The phone number is 202–566–1752. • Hand Delivery: The ORD Docket is located in EPA’s Headquarters Docket Center, Room 3334 EPA West Building, 1301 Constitution Ave. NW, Washington, DC. If you provide materials by mail or hand delivery, please submit three copies of these materials. For attachments, provide an index, number pages consecutively with the materials, and submit an unbound original and three copies. Instructions: Direct your comments to Docket ID No. EPA–HQ–ORD–2020– 0564. Please ensure that your comments are submitted within the specified PO 00000 Frm 00026 Fmt 4703 Sfmt 9990 15477 comment period. Comments received after the closing date will be marked ‘‘late,’’ and may only be considered if time permits. It is EPA’s policy to include all materials it receives in the public docket without change and to make the materials available online at www.regulations.gov, including any personal information provided, unless materials include information claimed to be Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. Do not submit information that you consider to be CBI or otherwise protected through www.regulations.gov or email. The www.regulations.gov website is an ‘‘anonymous access’’ system, which means EPA will not know your identity or contact information unless you provide it in the body of your comment. If you send an email directly to EPA without going through www.regulations.gov, your email address will be automatically captured and included as part of the materials that are placed in the public docket and made available on the internet. If you submit electronic materials, EPA recommends that you include your name and other contact information in the body of your materials and with any disk or CD–ROM you submit. If EPA cannot read your materials due to technical difficulties and cannot contact you for clarification, EPA may not be able to consider the materials you submit. Electronic files should avoid the use of special characters, any form of encryption, and be free of any defects or viruses. For additional information about EPA’s public docket, visit EPA’s Docket Center homepage at www.epa.gov/epahome/ dockets.htm. Docket: Documents in the docket are listed in the www.regulations.gov index. Although listed in the index, some information is not publicly available, e.g., CBI or other information whose disclosure is restricted by statute. Certain other materials, such as copyrighted material, are publicly available only in hard copy. Publicly available docket materials are available either electronically in www.regulations.gov or in hard copy at the ORD Docket in EPA’s Headquarters Docket Center. Authority: Pub. L. 94–475; Environmental Research, Development, and Demonstration Authorization Act of 1976. Dated: February 18, 2021. Vanessa Holt, Acting Director, Center for Public Health and Environmental Assessment (CPHEA). [FR Doc. 2021–05380 Filed 3–22–21; 8:45 am] BILLING CODE 6560–50–P E:\FR\FM\23MRN1.SGM 23MRN1

Agencies

ENVIRONMENTAL PROTECTION AGENCY

[Federal Register Volume 86, Number 54 (Tuesday, March 23, 2021)]
[Notices]
[Pages 15476-15477]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-05380]


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-----------------------------------------------------------------------

ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-ORD-2020-0564; FRL 10020-77-ORD]


Multiple-Path Particle Dosimetry (MPPD) Model Software (MPPD EPA 
2021 v.1.01) With Technical Support Documentation and User's Guide 
(External Review Draft)

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice; request for public comment.

-----------------------------------------------------------------------

SUMMARY: The Environmental Protection Agency (EPA) is announcing an 
external expert peer review and public comment for the EPA Multiple-
Path Particle Dosimetry (MPPD) Model Software (MPPD EPA 2021 v. 1.01) 
and its associated ``Technical Support Documentation and User's Guide 
(External Review Draft)'' ([EPA/600/R-20/406]). The document was 
prepared by the Center for Public Health and Environmental Assessment 
(CPHEA) within EPA's Office of Research and Development (ORD), with 
contributions from Applied Research Associates, Inc., and Fred J. 
Miller, LLC. EPA is releasing this draft model software version and 
associated document to seek review by external experts and the public. 
This external review draft document and model software (MPPD EPA 2021 
v. 1.01) are not final and do not represent, and should not be 
construed to represent, any final Agency policy or views. When revising 
the document and the model software, EPA will consider any peer or 
public comments submitted during the public comment period specified in 
this document.

DATES: The 30-day public comment period begins March 23, 2021 and ends 
April 22, 2021. Comments must be received on or before April 22, 2021.

ADDRESSES: The EPA Multiple-Path Particle Dosimetry (MPPD) Model 
Software (MPPD EPA 2021 v. 1.01) and its associated ``Technical Support 
Documentation and User's Guide'' (External Review Draft)'' will be 
available from the contractor managing the external peer review, 
Eastern Research Group, Inc. (ERG). To obtain a copy of the external 
review draft or the associated MPPD software (EPA 2021 v. 1.01), 
contact ERG at email: [email protected] with the Subject line: MPPD 
EPA 2021 Peer Review; Phone: 781-674-7362.

FOR FURTHER INFORMATION CONTACT: For information on the public comment 
period, contact the ORD Docket at the EPA Headquarters Docket Center;

[[Page 15477]]

phone: 202-566-1752; fax: 202-566-9744; or email: [email protected]. 
For technical information, contact Annie M. Jarabek; phone: 919-637-
6016; or email: [email protected].

SUPPLEMENTARY INFORMATION:

I. Information About the Document and MPPD Model Software

    The EPA is undertaking an external peer review of an EPA version of 
the Multiple-Path Particle Dosimetry (MPPD) model (MPPD EPA 2021 v. 
1.01) and its software, together with an EPA Technical Support 
Documentation and User's Guide. The EPA introduced formal dosimetry 
modeling into its derivation procedures for risk assessment of inhaled 
materials with its 1994 document entitled ``Methods for Derivation of 
Inhalation Reference Concentrations (RfCs) and Application of 
Inhalation Dosimetry'' (US EPA, 1994). These methods relied upon the 
Regional Deposited Dose Ratio (RDDR) model and underwent two expert 
technical panel and two expert Science Advisory Board (SAB) reviews 
prior to finalization. The dosimetry adjustments were also subsequently 
incorporated into the Agency's guidelines for carcinogen risk 
assessment (US EPA, 2005).
    The EPA RDDR model was an empirical model fit to a unique set of 
experimental data from inhalation studies across five laboratory animal 
species commonly used in testing for regulatory risk assessment as well 
as for humans. The model provided predictions of inhaled deposited dose 
in various regions of the respiratory tract, including the 
extrathoracic (ET), tracheobronchial (TB), pulmonary (PU), thoracic (TB 
+ PU) or total respiratory tract (TOTAL).
    However, since 1994, mechanistic modeling of inhalation dosimetry 
for particles has matured. The MPPD model and its software include many 
modernized features, with some dose metric predictions now based on 
mechanistic descriptions instead of empirical fitting, the ability to 
address a wider range of particle size, providing prediction of 
retained mass for some species, and including some different test 
species.
    The EPA is convening this external peer review to evaluate the MPPD 
model. The model results provide dosimetry adjustment of inhalation 
exposures for the following purposes: Interspecies extrapolation, 
evaluation of intra-human variability, informing experimental design, 
and in vitro to in vivo (IVIVE) extrapolation.
    The EPA Multiple-Path Particle Dosimetry (MPPD) Model Software 
(MPPD EPA 2021 v. 1.01) and its associated ``Technical Support 
Documentation and User's Guide (External Review Draft)'' will be 
discussed at a virtual external expert peer review meeting, which will 
be open to the public. In addition to the opportunity to submit written 
comments during the public comment period announced in this notice, the 
public will have an opportunity to make brief oral comments during the 
virtual expert peer panel meeting. For more information about the peer 
review meeting, including information about how to register, please 
visit: https://projects.erg.com/conferences/peerreview/register-mppd.html.

II. How To Submit Technical Comments to the Docket at 
www.regulations.gov

    Out of an abundance of caution for members of the public and our 
staff, the EPA Docket Center and Reading Room are closed to the public, 
with appointment only, to reduce the risk of transmitting COVID-19. Our 
Docket Center staff will continue to provide remote customer service 
via email, phone, and webform. We encourage the public to submit 
comments via the web at https://www.regulations.gov/ or via email at 
[email protected], as there may be a delay in processing mail and 
faxes. Hand deliveries and couriers may be received by scheduled 
appointment only. For further information on EPA Docket Center services 
and the current status, please visit https://www.epa.gov/dockets.
    Submit your materials identified by Docket ID No. EPA-HQ-ORD-2020-
0564 by one of the following methods:
     www.regulations.gov: Follow the online instructions for 
submitting comments.
     Email: [email protected].
     Fax: 202-566-9744.
     Mail: Office of Research and Development (ORD) Docket 
(Mail Code: 28221T), U.S. Environmental Protection Agency, 1200 
Pennsylvania Ave. NW, Washington, DC 20460. The phone number is 202-
566-1752.
     Hand Delivery: The ORD Docket is located in EPA's 
Headquarters Docket Center, Room 3334 EPA West Building, 1301 
Constitution Ave. NW, Washington, DC. If you provide materials by mail 
or hand delivery, please submit three copies of these materials. For 
attachments, provide an index, number pages consecutively with the 
materials, and submit an unbound original and three copies.
    Instructions: Direct your comments to Docket ID No. EPA-HQ-ORD-
2020-0564. Please ensure that your comments are submitted within the 
specified comment period. Comments received after the closing date will 
be marked ``late,'' and may only be considered if time permits. It is 
EPA's policy to include all materials it receives in the public docket 
without change and to make the materials available online at 
www.regulations.gov, including any personal information provided, 
unless materials include information claimed to be Confidential 
Business Information (CBI) or other information whose disclosure is 
restricted by statute. Do not submit information that you consider to 
be CBI or otherwise protected through www.regulations.gov or email. The 
www.regulations.gov website is an ``anonymous access'' system, which 
means EPA will not know your identity or contact information unless you 
provide it in the body of your comment. If you send an email directly 
to EPA without going through www.regulations.gov, your email address 
will be automatically captured and included as part of the materials 
that are placed in the public docket and made available on the 
internet. If you submit electronic materials, EPA recommends that you 
include your name and other contact information in the body of your 
materials and with any disk or CD-ROM you submit. If EPA cannot read 
your materials due to technical difficulties and cannot contact you for 
clarification, EPA may not be able to consider the materials you 
submit. Electronic files should avoid the use of special characters, 
any form of encryption, and be free of any defects or viruses. For 
additional information about EPA's public docket, visit EPA's Docket 
Center homepage at www.epa.gov/epahome/dockets.htm.
    Docket: Documents in the docket are listed in the 
www.regulations.gov index. Although listed in the index, some 
information is not publicly available, e.g., CBI or other information 
whose disclosure is restricted by statute. Certain other materials, 
such as copyrighted material, are publicly available only in hard copy. 
Publicly available docket materials are available either electronically 
in www.regulations.gov or in hard copy at the ORD Docket in EPA's 
Headquarters Docket Center.

    Authority: Pub. L. 94-475; Environmental Research, Development, 
and Demonstration Authorization Act of 1976.

    Dated: February 18, 2021.
Vanessa Holt,
Acting Director, Center for Public Health and Environmental Assessment 
(CPHEA).
[FR Doc. 2021-05380 Filed 3-22-21; 8:45 am]
BILLING CODE 6560-50-P

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