[Federal Register: November 8, 2006 (Volume 71, Number 216)]
[Notices]
[Page 65483-65484]
[DOCID:fr08no06-63]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings  1

November 1, 2006.
    Take notice that the Commission received the following electric
corporate filings:
    Docket Number: EC07-7-000.
    Applicants: TPG Generations Holdings, LLC; High Desert Power
Project; Holland Energy, LLC; Wolf Hills Energy, LLC; University Park
Energy, LLC; Big Sandy Peaker Plant, LLC.
    Description: TPF Generation Holdings, LLC, High Desert Power
Project, LLC et al. submit a section 203 application for indirect
transfer of various public utility owners of existing generation
facilities.
    Filed Date: 10/23/2006.
    Accession Number: 20061030-0196.
    Comment Date: 5 p.m. Eastern Time on Monday, November 13, 2006.

    Docket Number: EC07-8-000.
    Applicant: KGen Marshall LLC.
    Description: KGen Marshall LLC submits an Application requesting
approval of an expedited sale of jurisdictional assets, et al. to
Tennessee Valley Authority.
    Filed Date: 10/25/2006.
    Accession Number: 20061031-0067.
    Comment Date: 5 p.m. Eastern Time on Wednesday, November 15, 2006.

    Docket Number: EC07-9-000.
    Applicant: Dynegy Inc.
    Description: Dynegy, Inc et al. submits their application
requesting authorization to consummate a transaction by which the
interest in specific jurisdictional facilities.
    Filed Date: 10/26/2006.
    Accession Number: 20061101-0176.
    Comment Date: 5 p.m. Eastern Time on Monday, November 27, 2006.

    Docket Number: EC07-10-000.
    Applicants: Central Illinois Light Company; AmerenEnergy Resources
Generating Company.
    Description: Central Illinois Light Company and AmerenEnergy
Resources Gen Co. submits a joint Application for approval of the
Disposition of Jurisdictional Facilities under Section 203 of the FPA.
    Filed Date: 10/27/2006.
    Accession Number: 20061031-0156.
    Comment Date: 5 p.m. Eastern Time on Friday, November 17, 2006.
    Take notice that the Commission received the following electric
rate filings:
    Docket Number: ER00-3562-004.
    Applicant: Calpine Energy Services LP.
    Description: Calpine Energy Services, LP submits its updated
triennial market power analysis pursuant to FERC's 10/30/03 Order.
    Filed Date: 10/30/2006.
    Accession Number: 20061101-0168.
    Comment Date: 5 p.m. Eastern Time on Monday, November 20, 2006.

    Docket Numbers: ER02-999-004; ER05-320-002; ER97-2460-007; ER97-
2463-004.
    Applicants: Unitil Energy Systems, Inc.; Unitil Power Corporation;
Fitchburg Gas Company.
    Description: Unitil Energy Systems, Inc et al. submits their
updated market power analysis with respect to each company's authority
to make sales at market-based rate etc. pursuant to FERC's 2/2/05
Order.
    Filed Date: 10/30/2006.
    Accession Number: 20061101-0161.
    Comment Date: 5 p.m. Eastern Time on Monday, November 20, 2006.

    Docket Number: ER03-765-002.
    Applicant: Calpine Oneta Power, LP.
    Description: Calpine Oneta Power, LP submits its Amended Compliance
filing for Rate Schedule FERC 2.
    Filed Date: 10/27/2006.
    Accession Number: 20061030-0240.
    Comment Date: 5 p.m. Eastern Time on Friday, November 17, 2006.

    Docket Number: ER05-1179-006.
    Applicant: Berkshire Power Company, LLC.
    Description: Berkshire Power Company, LLC submits a Compliance
Electric Refund Report.
    Filed Date: 10/30/2006.
    Accession Number: 20061030-5101.
    Comment Date: 5 p.m. Eastern Time on Monday, November 20, 2006.

    Docket Number: ER06-192-001.
    Applicant: Midwest Independent Transmission System Operator, Inc.
    Description: Midwest Independent Transmission System Operator, Inc.
submits its 2006 Amended Compliance Filing and initial Compliance
Filing with regard to the requirements of Order 2006-A and 2006-B.
    Filed Date: 10/25/2006.
    Accession Number: 20061030-0185.
    Comment Date: 5 p.m. Eastern Time on Wednesday, November 15, 2006.

    Docket Number: ER06-1437-001.
    Applicants: Kentucky Utilities Company; Louisville Gas and Electric
Company.
    Description: E.ON US, LLC on behalf of Louisville Gas and Electric
Co. et al. submits an executed Firm Point-to-Point transmission service
agreement with Indiana Municipal Power Agency.
    Filed Date: 10/30/2006.
    Accession Number: 20061101-0145.
    Comment Date: 5 p.m. Eastern Time on Monday, November 20, 2006.

    Docket Number: ER07-45-001.
    Applicant: Horizon Power and Light LLC.
    Description: Horizon Power and Light LLC submits an amendment to
the petition for acceptance of initial rate schedule, waivers and
blanket authority.
    Filed Date: 10/27/2006.
    Accession Number: 20061101-0146.
    Comment Date: 5 p.m. Eastern Time on Friday, November 17, 2006.

    Docket Number: ER07-75-000.
    Applicant: Southern California Edison Company.
    Description: Southern California Edison Company submits revisions
to its Transmission Owner Tariff, FERC Electric Tariff, Second Revised
Volume 6 and to certain existing transmission contracts to reflect
change in Reliability Service Rates.
    Filed Date: 10/26/2006.
    Accession Number: 20061031-0006.
    Comment Date: 5 p.m. Eastern Time on Thursday, November 16, 2006.

    Docket Number: ER07-86-000.
    Applicant: Entergy Services Inc.
    Description: Entergy Services, Inc submits Revisions to its Open
Access Transmission Tariff, to its FERC Electric Tariff, Second Revised
Volume 3.
    Filed Date: 10/30/2006.
    Accession Number: 20061101-0153.
    Comment Date: 5 p.m. Eastern Time on Monday, November 20, 2006.

    Docket Number: ER07-87-000.
    Applicants: ISO New England Inc.; New England Participating

Transmission Owners, Maine Electric Power Company, and New England
Power Pool.
    Description: ISO New England, Inc et al. submits proposed
amendments on the standardization of small generator interconnection
agreements and procedures pursuant to FERC's Order 2006-B.
    Filed Date: 10/29/2006.
    Accession Number: 20061101-0154.
    Comment Date: 5 p.m. Eastern Time on Monday, November 20, 2006.

    Docket Numbers: ER07-92-000.
    Applicants: ISO New England Inc.; New England Power Pool
Participants Committee.
    Description: ISO New England Inc et al. submits its Price Finality
Market Package revisions.
    Filed Date: 10/30/2006.
    Accession Number: 20061101-0157.
    Comment Date: 5 p.m. Eastern Time on Monday, November 20, 2006.

    Docket Number: ER07-93-000.
    Applicant: Entergy Services Inc.
    Description: Entergy Operating Companies submits a new Schedule 9
and 10 to its Open Access Transmission Tariff and related amendments to
the transmission rate formulas for pt-to-pt, et al.
    Filed Date: 10/30/2006.
    Accession Number: 20061101-0160.
    Comment Date: 5 p.m. Eastern Time on Monday, November 20, 2006.

    Docket Number: ER07-94-000.
    Applicant: California Power Exchange Corporation.
    Description: California Power Exchange Corporation submits proposed
amendments to its Rate Schedule 1 in order to recover projected
expenses for the period of 1/1/07-6/30/07.
    Filed Date: 10/30/2006.
    Accession Number: 20061101-0159.
    Comment Date: 5 p.m. Eastern Time on Monday, November 20, 2006.

    Docket Number: ER07-95-000.
    Applicants: Michigan Electric Transmission Company, LLC; Midwest
Independent Transmission System Operator, Inc.
    Description: Midwest Independent Transmission System Operator, Inc
et al. submit proposed revisions to the Midwest ISO's OAT&EM Tariff,
Third Revised Volume 1.
    Filed Date: 10/30/2006.
    Accession Number: 20061101-0155.
    Comment Date: 5 p.m. Eastern Time on Monday, November 20, 2006.

    Docket Numbers: ER98-1734-012; ER07-98-000.
    Applicant: Commonwealth Edison Company.
    Description: Commonwealth Edison Co modifies its market based
tariff to remove the market behavior rules, delete the Code of Conduct
re Public Service Enterprise Group Inc and update identifying
information etc.
    Filed Date: 10/25/2006.
    Accession Number: 20061027-0003.
    Comment Date: 5 p.m. Eastern Time on Wednesday, November 15, 2006.
    Take notice that the Commission received the following public
utility holding company filings:
    Docket Number: PH07-3-000.
    Applicant: Enbridge Inc.
    Description: Enbridge Inc. submits an Exemption Notification
pursuant to 18 CFR sections 366.2, et al.
    Filed Date: 10/30/2006.
    Accession Number: 20061027-5093.
    Comment Date: 5 p.m. Eastern Time on Monday, November 20, 2006.

    Docket Number: PH07-4-000.
    Applicant: Sun Capital Partners III, LLC.
    Description: SUN CAPITAL PARTNERS III, LLC submits a petition for
waiver of the Commission's Regulations and PUHCA 2005.
    Filed Date: 10/31/2006.
    Accession Number: 20061031-5019.
    Comment Date: 5 p.m. Eastern Time on Tuesday, November 21, 2006.

    Any person desiring to intervene or to protest in any of the above
proceedings must file in accordance with Rules 211 and 214 of the
Commission's Rules of Practice and Procedure (18 CFR 385.211 and
385.214) on or before 5 p.m. Eastern Time on the specified comment
date. It is not necessary to separately intervene again in a subdocket
related to a compliance filing if you have previously intervened in the
same docket. Protests will be considered by the Commission in
determining the appropriate action to be taken, but will not serve to
make protestants parties to the proceeding. Anyone filing a motion to
intervene or protest must serve a copy of that document on the
Applicant. In reference to filings initiating a new proceeding,
interventions or protests submitted on or before the comment deadline
need not be served on persons other than the Applicant.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper, using the FERC Online links at http://www.ferc.gov.
 To facilitate electronic service, persons with Internet

access who will eFile a document and/or be listed as a contact for an
intervenor must create and validate an eRegistration account using the
eRegistration link. Select the eFiling link to log on and submit the
intervention or protests.
    Persons unable to file electronically should submit an original and
14 copies of the intervention or protest to the Federal Energy
Regulatory Commission, 888 First St. NE., Washington, DC 20426.
    The filings in the above proceedings are accessible in the
Commission's eLibrary system by clicking on the appropriate link in the
above list. They are also available for review in the Commission's
Public Reference Room in Washington, DC. There is an eSubscription link
on the Web site that enables subscribers to receive e-mail notification
when a document is added to a subscribed dockets(s). For assistance
with any FERC Online service, please e-mail<EMAIL_ADDRESS>
or call<PHONE_NUMBER> (toll free). For TTY, call<PHONE_NUMBER>.

Magalie R. Salas,
Secretary.
[FR Doc. E6-18805 Filed 11-7-06; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 77, Number 226 (Friday, November 23, 2012)]
[Notices]
[Pages 70202-70203]
[FR Doc No: 2012-28384]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-68253; File No. SR-ICC-2012-20]

Self-Regulatory Organizations; ICE Clear Credit LLC; Notice of
Filing and Immediate Effectiveness of Proposed Rule Change to Amend
Schedule 502 of the ICC Rules to Update the Contract Reference
Obligation ISIN Associated With One Single Name Contract

November 16, 2012.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act'') \1\ and Rule 19b-4 thereunder,\2\ notice is hereby given that
on November 5, 2012, ICE Clear Credit LLC (``ICC'') filed with the
Securities and Exchange Commission (``Commission'') the proposed rule
change described in Items I, II, and III below, which items have been
prepared primarily by ICC. ICC filed the proposal pursuant to Section
19(b)(3)(A)(iii) of the Act \3\, and Rule 19b-4(f)(3)\4\ thereunder so
that the proposal was effective upon filing with the Commission. The
Commission is publishing this Notice to solicit comments on the
proposed rule change from interested persons.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ 15 U.S.C. 78s(b)(3)(A)(iii).
    \4\ 17 CFR 240.19b-4(f)(3).
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I. Self-Regulatory Organization's Statement of Terms of Substance of
the Proposed Rule Change

    The purpose of the proposed rule change is to update the Contract
Reference Obligation International Securities Identification Number
(``Contract Reference Obligation ISIN'') in Schedule 502 of the ICC
Rules in order to be consistent with the industry standard reference
obligation for one single name contract that ICC currently clears
(Nucor Corporation).

II. Self-Regulatory Organization's Statement of Purpose of, and
Statutory Basis for, the Proposed Rule Change

    In its filing with the Commission, ICC included statements
concerning the purpose of and basis for the proposed rule change and
discussed any comments it received on the proposed rule change. The
text of these statements may be examined at the places specified in
Item IV below. ICC has prepared summaries, set forth in sections A, B,
and C below, of the most significant aspects of such statements.\5\
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    \5\ The Commission has modified the text of the summaries
prepared by ICC.
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A. Self-Regulatory Organization's Statement of Purpose of, and
Statutory Basis for, the Proposed Rule Change

    ICC is updating the Contract Reference Obligation ISIN in Schedule
502 of the ICC Rules in order to be consistent with the industry
standard reference obligation for one single name contract that ICC
currently clears (Nucor Corporation). The Contract Reference Obligation
ISIN update does not require any changes to the ICC risk management
framework or the body of the ICC Rules. The only change being submitted
is the update to the Contract Reference Obligation ISIN for Nucor
Corporation in Schedule 502 of the ICC Rules.
    Section 17A(b)(3)(F) of the Act \6\ requires, among other things,
that the rules of a clearing agency be designed to promote the prompt
and accurate clearance and settlement of securities transactions and,
to the extent applicable, derivative agreements, contracts, and
transactions. ICC believes that the proposed rule change is consistent
with the requirements of the Act, and the rules and regulations
thereunder applicable to ICC, because the update to the Contract
Reference Obligation ISIN for Nucor Corporation will facilitate the
prompt and accurate settlement of securities transactions and
contribute to the safeguarding of securities and funds associated with
swap transactions, which are in the custody or control of ICC or for
which it is responsible, by ensuring that ICC's internal records are up
to date and reflect accurate information concerning a product that ICC
clears.
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    \6\ 15 U.S.C. 78q-1(b)(3)(F).
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B. Self-Regulatory Organization's Statement on Burden on Competition

    ICC does not believe that the proposed rule change will have any
impact or impose any burden on competition.

C. Self-Regulatory Organization's Statement on Comments on the Proposed
Rule Change Received From Members, Participants, or Others

    Written comments relating to the proposed rule change have not been
solicited or received. ICC will notify the Commission of any written
comments received by ICC.

III. Date of Effectiveness of the Proposed Rule Change and Timing for
Commission Action

    The foregoing rule change has become effective pursuant to Section
19(b)(3)(A)(iii) \7\ of the Act and Rule

19b-4(f)(3) \8\ thereunder because it is concerned solely with the
administration of the self-regulatory organization. At any time within
60 days of the filing of the proposed rule change, the Commission
summarily may temporarily suspend such rule change if it appears to the
Commission that such action is necessary or appropriate in the public
interest, for the protection of investors, or otherwise in furtherance
of the purposes of the Act.\9\
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    \7\ 15 U.S.C. 78s(b)(3)(A)(iii).
    \8\ 17 CFR 240.19b-4(f)(3).
    \9\ 15 U.S.C. 78s(b)(3)(C).
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IV. Solicitation of Comments

    Interested persons are invited to submit written data, views and
arguments concerning the foregoing, including whether the proposed rule
change is consistent with the Act. Comments may be submitted by any of
the following methods:

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml), or
     Send an email to<EMAIL_ADDRESS>Please include
File No. SR-ICC-2012-20 on the subject line.

Paper Comments

     Send paper comments in triplicate to Elizabeth M. Murphy,
Secretary, Securities and Exchange Commission, 100 F Street NE.,
Washington, DC, 20549-1090.

All submissions should refer to File Number SR-ICC-2012-20. This file
number should be included on the subject line if email is used. To help
the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml). Copies of the submission, all subsequent amendments, all
written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for Web site viewing and
printing in the Commission's Public Reference Room, 100 F Street NE.,
Washington, DC 20549 on official business days between the hours of
10:00 a.m. and 3:00 p.m. Copies of such filing also will be available
for inspection and copying at the principal office of ICE Clear Credit
and on ICE Clear Credit's Web site at https://www.theice.com/publicdocs/regulatory_filings/ICEClearCredit_110512.pdf.
    All comments received will be posted without change; the Commission
does not edit personal identifying information from submissions. You
should submit only information that you wish to make available
publicly. All submissions should refer to File Number SR-ICC-2012-20
and should be submitted on or before December 14, 2012.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\10\
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    \10\ 17 CFR 200.30-3(a)(12).
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Kevin M. O'Neill,
Deputy Secretary.
[FR Doc. 2012-28384 Filed 11-21-12; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 86, Number 235 (Friday, December 10, 2021)]
[Rules and Regulations]
[Pages 70378-70380]
[FR Doc No: 2021-26791]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket Number USCG-2021-0865]
RIN 1625-AA00

Safety Zone; Frantic Inc Chase Center Fireworks, San Francisco
Bay, San Francisco, CA

AGENCY: Coast Guard, DHS.

ACTION: Temporary final rule.

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SUMMARY: The Coast Guard is establishing a temporary safety zone on the
navigable waters of the San Francisco Bay near Chase Center in San
Francisco, CA in support of a fireworks display on December 19, 2021.
The safety zone is necessary to protect personnel, vessels, and the
marine environment from potential hazards created by pyrotechnics.
Unauthorized persons or vessels are prohibited from entering into,
transiting through, or remaining in the safety zone without the
permission of the Captain of the Port San Francisco or a designated
representative.

DATES: This rule is effective from 11 a.m. until 10:40 p.m. on December
19, 2021.

ADDRESSES: To view documents mentioned in this preamble as being
available in the docket, go to https://www.regulations.gov, type USCG-
2021-0865 in the search box and click ``Search.'' Next, in the Document
Type column, select ``Supporting & Related Material.''

FOR FURTHER INFORMATION CONTACT: If you have questions on this rule,
call or email Lieutenant Anthony I. Solares, U.S. Coast Guard District
11, Sector San Francisco, at<PHONE_NUMBER>, [email protected].

SUPPLEMENTARY INFORMATION:

I. Table of Abbreviations

CFR Code of Federal Regulations
DHS Department of Homeland Security
FR Federal Register
NPRM Notice of proposed rulemaking
Sec.  Section
U.S.C. United States Code

II. Background Information and Regulatory History

    The Coast Guard is issuing this temporary rule without prior notice
and opportunity to comment pursuant to authority under section 4(a) of
the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This
provision authorizes an agency to issue a rule without prior notice and
opportunity to comment when the agency for good cause finds that those
procedures are ``impracticable, unnecessary, or contrary to the public
interest.'' Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good
cause exists for not publishing a notice of proposed rulemaking (NPRM)
with respect to this rule because it is impracticable. The Coast Guard
did not receive final details for this event until November 10, 2021.
It is impracticable to go through the full notice and comment rule
making process because the Coast Guard must establish this safety zone
by December 19, 2021 and lacks sufficient time to provide a reasonable
comment period and to consider those comments before issuing the rule.
    Under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause
exists for making this rule effective less than 30 days after
publication in the Federal Register. Delaying the effective date of
this rule would be contrary to public interest because action is
necessary to protect personnel, vessels, and the marine environment
from the potential safety hazards associated with the fireworks display
near Chase Center in the San Francisco Bay on December 19, 2021.

III. Legal Authority and Need for Rule

    The Coast Guard is issuing this rule under authority 46 U.S.C.
70034 (previously 33 U.S.C. 1231). The Captain of the Port San
Francisco has determined that potential hazards associated with the
Frantic Inc Chase Center Fireworks on December 19, 2021, will be a
safety concern for anyone within a 100-foot radius of the fireworks
vessel during loading and staging, and anyone within a 700-foot radius
of the fireworks vessel starting 30 minutes before the fireworks
display is scheduled to commence and ending 30 minutes after the
conclusion of the fireworks display. For this reason, this temporary
safety zone is needed to protect personnel, vessels, and the marine
environment in the navigable waters around the fireworks vessel and
during the fireworks display.

IV. Discussion of the Rule

    This rule establishes a temporary safety zone from 11 a.m. until
10:40 p.m. on December 19, 2021, during the loading, staging, and
transit of the fireworks vessel in San Francisco Bay from Pier 50 to
1000 feet off Chase Center, San Francisco, CA, and until 30 minutes
after completion of the fireworks display. During the loading, staging,
and transit of the fireworks vessel scheduled to take place between 11
a.m. and 9:15 p.m. on December 19, 2021, until 30 minutes prior to the
start of the fireworks display, the safety zone will encompass the
navigable waters around and under the fireworks vessel, from surface to
bottom, within a circle formed by connection of all points 100 feet out
from the fireworks vessel. The fireworks display is scheduled to start
at 10:00 p.m. December 19, 2021 and end at approximately 10:10 p.m. on
December 19, 2021, 1,000 feet from Chase Center in San Francisco, CA.
    The fireworks vessel will remain at Pier 50 until the start of its
transit to the display location. Movement of the vessel from Pier 50 to
the display location is scheduled to take place from 8:45 p.m. to 9:15
p.m. on December 19, 2021, where it will remain until the conclusion of
the fireworks display.
    At 9:30 p.m. on December 19, 2021, 30 minutes prior to the
commencement of the 10-minute fireworks display, the safety zone will
increase in size and encompass the navigable waters around and under
the fireworks vessel, from surface to bottom, within a circle formed by
all connecting points 700 feet from the circle center at approximate
position 37[deg]46'02.82'' N, 122[deg]22'56.00'' W (NAD 83), or as
announced via Broadcast Notice to Mariners. The safety zone will
terminate at 10:40 p.m. on December 19, 2021.
    This regulation is necessary to keep persons and vessels away from
the immediate vicinity of the fireworks loading, staging, transit, and
display site. Except for persons or vessels authorized by the COTP or
the COTP's designated representative, no person or vessel may enter or
remain in the restricted area. A ``designated representative'' means a
Coast Guard Patrol Commander, including a Coast Guard coxswain, petty
officer, or other officer operating a Coast Guard vessel, or a Federal,
State, or local officer designated by or assisting the Captain of the
Port San Francisco (COTP) in the enforcement of the safety zone. This
regulation is necessary to ensure the safety of participants,
spectators, and transiting vessels.

V. Regulatory Analyses

    We developed this rule after considering numerous statutes and
Executive orders related to rulemaking. Below we summarize our analyses
based on a number of these statutes and Executive orders, and we
discuss First Amendment rights of protestors.

A. Regulatory Planning and Review

    Executive Orders 12866 and 13563 direct agencies to assess the
costs and benefits of available regulatory

alternatives and, if regulation is necessary, to select regulatory
approaches that maximize net benefits. This rule has not been
designated a ``significant regulatory action,'' under Executive Order
12866. Accordingly, this rule has not been reviewed by the Office of
Management and Budget (OMB).
    This regulatory action determination is based on the limited
duration and narrowly tailored geographic area of the safety zone.
Although this rule restricts access to the waters encompassed by the
safety zone, the effect of this rule will not be significant because
the local waterways users will be notified to ensure the safety zone
will result in minimum impact. The vessels desiring to transit through
or around the temporary safety zone may do so upon express permission
from the COTP or the COTP's designated representative.

B. Impact on Small Entities

    The Regulatory Flexibility Act of 1980, 5 U.S.C. 601-612, as
amended, requires Federal agencies to consider the potential impact of
regulations on small entities during rulemaking. The term ``small
entities'' comprises small businesses, not-for-profit organizations
that are independently owned and operated and are not dominant in their
fields, and governmental jurisdictions with populations of less than
50,000. The Coast Guard certifies under 5 U.S.C. 605(b) that this rule
will not have a significant economic impact on a substantial number of
small entities.
    While some owners or operators of vessels intending to transit the
safety zone may be small entities, for the reasons stated in section
V.A above, this rule will not have a significant economic impact on any
vessel owner or operator.
    Under section 213(a) of the Small Business Regulatory Enforcement
Fairness Act of 1996 (Pub. L. 104-121), we want to assist small
entities in understanding this rule. If the rule would affect your
small business, organization, or governmental jurisdiction and you have
questions concerning its provisions or options for compliance, please
call or email the person listed in the FOR FURTHER INFORMATION CONTACT
section.
    Small businesses may send comments on the actions of Federal
employees who enforce, or otherwise determine compliance with, Federal
regulations to the Small Business and Agriculture Regulatory
Enforcement Ombudsman and the Regional Small Business Regulatory
Fairness Boards. The Ombudsman evaluates these actions annually and
rates each agency's responsiveness to small business. If you wish to
comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR
(1-888-734-3247). The Coast Guard will not retaliate against small
entities that question or complain about this rule or any policy or
action of the Coast Guard.

C. Collection of Information

    This rule will not call for a new collection of information under
the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).

D. Federalism and Indian Tribal Governments

    A rule has implications for federalism under Executive Order 13132,
Federalism, if it has a substantial direct effect on the States, on the
relationship between the National Government and the States, or on the
distribution of power and responsibilities among the various levels of
government. We have analyzed this rule under that Order and have
determined that it is consistent with the fundamental federalism
principles and preemption requirements described in Executive Order
13132.
    Also, this rule does not have tribal implications under Executive
Order 13175, Consultation and Coordination with Indian Tribal
Governments, because it does not have a substantial direct effect on
one or more Indian tribes, on the relationship between the Federal
Government and Indian tribes, or on the distribution of power and
responsibilities between the Federal Government and Indian tribes.

E. Unfunded Mandates Reform Act

    The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538)
requires Federal agencies to assess the effects of their discretionary
regulatory actions. In particular, the Act addresses actions that may
result in the expenditure by a State, local, or tribal government, in
the aggregate, or by the private sector of $100,000,000 (adjusted for
inflation) or more in any one year. Though this rule will not result in
such an expenditure, we do discuss the effects of this rule elsewhere
in this preamble.

F. Environment

    We have analyzed this rule under Department of Homeland Security
Directive 023-01, Rev. 1, associated implementing instructions, and
Environmental Planning COMDTINST 5090.1 (series), which guide the Coast
Guard in complying with the National Environmental Policy Act of 1969
(42 U.S.C. 4321-4370f), and have determined that this action is one of
a category of actions that do not individually or cumulatively have a
significant effect on the human environment. This rule involves a
temporary safety zone in the navigable waters around the loading,
staging, transit, and display of fireworks near Pier 50 and 1,000 feet
off Chase Center in San Francisco Bay. It is categorically excluded
from further review under paragraph L60(a) of Appendix A, Table 1 of
DHS Instruction Manual 023-01-001-01, Rev. 1. A Record of Environmental
Consideration supporting this determination is available in the docket.
For instructions on locating the docket, see the ADDRESSES section of
this preamble.

G. Protest Activities

    The Coast Guard respects the First Amendment rights of protesters.
Protesters are asked to call or email the person listed in the FOR
FURTHER INFORMATION CONTACT section to coordinate protest activities so
that your message can be received without jeopardizing the safety or
security of people, places or vessels.

List of Subjects in 33 CFR Part 165

    Harbors, Marine safety, Navigation (water), Reporting and
recordkeeping requirements, Security measures, Waterways.

    For the reasons discussed in the preamble, the Coast Guard amends
33 CFR part 165 as follows:

PART 165--REGULATED NAVIGATION AREAS AND LIMITED ACCESS AREAS

0
1. The authority citation for part 165 continues to read as follows:

    Authority:  46 U.S.C. 70034, 70051; 33 CFR 1.05-1, 6.04-1. 6.04-
6, and 160.5; Department of Homeland Security Delegation No.
00170.1, Revision No. 01.2.

0
2. Add Sec.  165.T11-080 to read as follows:

Sec.  165.T11-080  Safety Zone; Frantic Inc Chase Center Fireworks, San
Francisco Bay, San Francisco, CA.

    (a) Location. This safety zone encompasses all navigable waters of
San Francisco Bay, from surface to bottom, within a circle formed by
connecting all points 100 feet out from the fireworks vessel during
loading and staging at Pier 50 in San Francisco, as well as transit and
arrival 1,000 feet off of Chase Center, San Francisco, CA. Between 9:30
p.m. on December 19, 2021 and 10:40 p.m. on December 19, 2021, the
safety zone will expand to all navigable waters, from surface to
bottom, within a circle formed by connection all points 700 feet out
from the fireworks vessel in approximate position 37[deg]46'02.82'' N,

122[deg]22'56.00'' W (NAD 83) or as announced via Broadcast Notice to
Mariners.
    (b) Definitions. As used in this section, ``designated
representative'' means a Coast Guard Patrol Commander, including a
Coast Guard coxswain, petty officer, or other officer operating a Coast
Guard vessel, or a Federal, State, or Local officer designated by or
assisting the Captain of the Port San Francisco (COTP) in the
enforcement of the safety zone.
    (c) Regulations. (1) Under the general safety zone regulations in
subpart C of this part, you may not enter the safety zone described in
paragraph (a) of this section unless authorized by the COTP or the
COTP's designated representative.
    (2) The safety zone is closed to all vessel traffic, except as may
be permitted by the COTP or the COTP's designated representative.
    (3) Vessel operators desiring to enter or operate within the safety
zone must contact the COTP or the COTP's designated representative to
obtain permission to do so. Vessel operators given permission to enter
or operate in the safety zone must comply with all lawful orders or
directions given to them by the COTP or the COTP's designated
representative. Persons and vessels may request permission to enter the
safety zone on VHF-23A or through the 24-hour Command Center at
telephone<PHONE_NUMBER>.
    (d) Enforcement period. This section will be enforced from 11 a.m.
until 10:40 p.m. on December 19, 2021.
    (e) Information broadcasts. The COTP or the COTP's designated
representative will notify the maritime community of periods during
which this zone will be enforced, in accordance with 33 CFR 165.7.

    Dated: December 6, 2021.
Taylor Q. Lam,
Captain, U.S. Coast Guard, Captain of the Port, San Francisco.
[FR Doc. 2021-26791 Filed 12-9-21; 8:45 am]
BILLING CODE 9110-04-P


Page 1 of 20 UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D. C. 20460 OFFICE OF PREVENTION, PESTICIDES AND TOXIC SUBSTANCES MEMORANDUM June 21, 2006 SUBJECT: I. D. No. TRED 0024 26059: Boric Acid/ Sodium Salts of Boric Acid. Phase 4: Response to Public Comments for the Health Effects Division ( HED) Chapter of the Tolerance Reassessment Eligibility Decision ( TRED) Decision Document.

PC Codes: 011001 ( boric acid), 011102 ( sodium tetraborate decahydrate), 011110 ( sodium tetraborate pentahydrate), 011112 ( sodium tetraborate anhydrous), 011103 ( disodium octaborate tetrahydrate), 011107 ( disodium octaborate anhydrous), 011104 ( sodium metaborate) DP Barcodes: D320882, D320893 FROM: Linnea J. Hansen, Ph. D., Biologist Toxicology Branch Health Effects Division ( 7509P) AND Jeff Evans, Senior Biologist Chemistry and Exposure Branch Health Effects Division ( 7509P)

TO: Nathan Mottl/ Laura Parsons ( RM 51) Reregistration Branch I Reregistration Division ( 7508P)

THROUGH: Louis Scarano, Ph. D. Chief, Toxicology Branch Health Effects Division ( 7509P)

I. CONCLUSIONS The Health Effects Division ( HED) of the EPA Office of Pesticide Programs ( OPP) has reviewed public comments submitted during the Phase 3 public comment period on the HED Chapter of the Tolerance Reassessment Eligibility Decision ( TRED) document on boric acid and sodium salts of boric acid ( Docket ID # EPA HQ OPP 2005 0062). Responses to specific comments are provided below under the Discussion Section of this memorandum. The comments pertinent to the hazard characterization have been addressed by Linnea Hansen and comments on exposure have been addressed by Jeff Evans. Page 2 of 20 A number of revisions to the HED TRED document per the submitted comments have been made, as appropriate. A more detailed response to comments is given below under the Discussion Section. The risk assessment endpoints and overall characterization of toxicity remain unchanged at this time. Revised MOEs have been calculated for some of the exposure scenarios and assessments of hand to mouth postapplication exposures resulting from wood treatment uses have been added.

Toxicology data requirements have been amended from the original TRED document posted for public comment and no further studies are required at this time. HED has determined that a 28 day inhalation toxicity study in the rat is not required, but may be required at a later date if sufficient inhalation exposure concerns are raised from new uses or new incident/ epidemiology data. It is requested, however, that any new toxicity studies on boric acid/ sodium borates that may be conducted at the request of other regulatory agencies also be submitted to the US EPA for review.

Additional data are requested to refine risk estimates for post application uses having MOEs below 100.

II. ACTION REQUESTED The Health Effects Division ( HED) was requested to respond to comments received on the HED Chapter of the Tolerance Reassessment Eligibility Decision ( TRED) for boric acid and sodium salts of boric acid. This document was available for public comment from February 22, 2006 through April 24, 2006. Comments were received from numerous registrants of products containing boric acid and/ or sodium borate salts, as well as from the Canadian Pesticide Management Regulatory Agency ( PMRA).

III. DISCUSSION COMMENTS ON THE HAZARD CHARACTERIZATION Comments on the hazard characterization portion of the HED TRED Chapter were submitted by the Canadian PMRA, US Borax and Nisus Corporation. Where similar comments from different sources were received, they are addressed in a single response.

1. Comment need for quantitative risk assessment: Nisus Corporation questioned the need to conduct a quantitative risk assessment for boric acid and sodium borates, based on several criteria ( low acute toxicity, low dermal absorption, lack of significant bioaccumulation, rapid mammalian excretion, lack of well documented human chronic toxicity).

Agency response: The Agency recognizes that boric acid and sodium borates meet many of the criteria of low risk chemicals, as outlined above. Furthermore, boron is a naturally occurring element found in food and drinking water and to which humans are constantly exposed at low levels. However, in multiple experimental animal species, boron has shown the potential to cause significant reproductive toxicity, including testicular atrophy, and developmental toxicity Page 3 of 20 in multiple experimental animal species. Developmental toxicity has been observed at doses that do not cause maternal toxicity and effects have been reported following single exposures. Effects to the male reproductive tract in experimental animals have been induced following short term exposures. Based on these findings, the Agency therefore determined that a quantitative risk assessment should be prepared to evaluate the contribution of pesticidal and other consumer use to total boron exposure.

2. Comment additional boric acid studies and published studies: US Borax and PMRA noted that the TRED document and the 1994 Reregistration Eligibility Decision document did not include several studies on boric acid in the toxicology profile. Other published studies were also mentioned.

Agency response: Summaries of additional studies on boric acid have been incorporated into the document and other studies considered in this response phase.

3. Comment use of dog dietary studies for endpoint: US Borax and PMRA disagreed with the EPA's decision to use the older dog dietary studies on boric acid and borax as the basis for toxicity endpoints, based on poor quality of the studies and uncertainties regarding the NOAEL/ LOAEL.

Agency response: The Agency concurs that the dog 38 week and 2 year dietary studies, conducted in the 1960' s prior to current study conduct guidelines, do not meet the current standards for guideline studies and are problematic to interpret. In evaluating the data for endpoint selection, the decision to use the dog study was based on joint consideration of the available dog studies, the toxicology database as a whole and the levels of dietary background exposure for humans relative to risk assessment endpoint values. The dog studies used to derive the endpoints in this assessment were used by IRIS in the evaluation conducted prior to the 2004 review, when a newer, well conducted rat developmental toxicity endpoint was selected as the basis for the RfD. In 1995, the HED RfD Committee also reviewed boric acid/ sodium borate salts and determined that the dog studies should be used for the RfD, with the developmental toxicity study in the rat as a co critical study. The NOAELs identified in these studies are similar ( 8.8 mg/ kg/ day for the dog study and 9.6 mg/ kg/ day for the rat study). Although interpretation of the dog studies was clearly complicated by the small number of animals evaluated and background effects, testicular effects could be reasonably established in the 38 week and 90 day studies. The NOAEL of 8.8 mg/ kg/ day identified by the study authors in the 2 year dog studies was used in this assessment ( see also comment 4 regarding rationale).

If EPA had chosen to consider the dog study unacceptable and use another study, an additional uncertainty factor would need to be added to the endpoint selected to account for lack of a major guideline study that may be the most sensitive species for testicular toxicity. For example, an additional factor of 3 for database uncertainty added to the rat reproductive NOAEL of 25 27 and the standard 100X uncertainty factor would achieve a value essentially the same as the endpoint identified in this TRED. Assessment of boron hazard also requires consideration of background intake via diet and drinking water. Use of an uncertainty factor of 1000, or identification of a lower NOAEL, would provide a value for risk assessment comparable to current estimates of daily dietary intake for humans. Although additional boron intake via diet Page 4 of 20 and drinking water was not accounted for in the test animals of the available studies, and would effectively increase the NOAEL, EPA did not consider it appropriate to establish an RfD falling within the range of normal moderate human dietary intake.

4, Comment consistency with EPA IRIS endpoint: US Borax and PMRA noted that the 2004 Agency IRIS review of boron selected a rat developmental toxicity as the critical study for the RfD. US Borax considered the IRIS RfD the appropriate endpoint to use for this risk assessment based on the Agency's stated goals of achieving consistency in risk assessments among programs.

Agency response: HED selected the testicular effects in the dog as the critical study for risk assessment ( 1) to allow characterization of potential risks to different subpopulations that may not include pregnant females at different durations of exposure and ( 2) to establish a conservative, but not unrealistic endpoint for such assessments. PMRA and other reviewing agencies ( e. g., EPA IRIS, WHO) have elected to use the rat developmental toxicity study in support of the RfD for boron due to its higher quality as a study. However, as pointed out by US Borax, the NOAELs used are essentially the same ( 8.8 mg/ kg/ day vs. 9.6 mg/ kg/ day), with differences in the uncertainty factors used ( IRIS used 66, whereas this assessment uses 100).

5. Comment database uncertainty: PMRA added an extra uncertainty factor of 10 in calculation of their RfD to account for uncertainties in the database from study inadequacy and increased sensitivity of offspring in the developmental toxicity studies.

Agency response: EPA chose what it considers a reasonable endpoint, that is probably somewhat conservative, to conduct its hazard assessment. It is noted that PMRA used an incremental RfD approach to assess additional exposure to boron via pesticidal and consumer products containing boric acid/ sodium borate salts that is above dietary background levels, whereas EPA values for risk assessment were inclusive of background exposure levels. Addition of a 3 10x database uncertainty factor to EPA's endpoint would result in a risk assessment value similar to calculated ranges of human normal daily dietary intake, which EPA considers unreasonably low. In contrast, since PMRA is using an incremental approach, acceptable additional boron exposure levels from such products would be expected to be relatively small.

5. Comment revised boron intake values for dog studies: US Borax noted that boron equivalent intake values for the dog studies were determined using standard dietary conversion factors. For the dog 38 week and 2 year studies used in deriving the endpoint, US Borax prepared boron average daily intake values derived from food consumption and body weight data from the original study report, resulting in slightly higher values than the original NOAEL of 8.8 mg/ kg/ day ( mean for the endpoint is 9.6 mg/ kg/ day and 10.9 mg/ kg/ day for borax and boric acid, respectively).

Agency response: The recalculated boron intake values provided by US Borax are noted by the Agency, but no changes were made to the current assessment since the differences from the original NOAEL are small and do not significantly affect the conclusions of the assessment. However, the data calculations prepared by US Borax were submitted and will be reviewed; the new values may be used for future risk assessments. Page 5 of 20 6. Comment endpoint for child risk assessment: US Borax questioned whether use of the testicular effects endpoint was appropriate for a child risk assessment.

Agency response: The Agency considered this issue in the determination of endpoints for different populations. It was concluded that the endpoint should be retained for exposure to children because there was uncertainty as to the potential effects of boron on the immature reproductive organs ( male or female) and on the development of the reproductive tract.

7. Comment adequacy of database: In addition to the dog studies, PMRA considered numerous other studies inadequate for hazard characterization and identified different NOAELs/ LOAELs for several studies. Problems with the reproductive toxicity studies and evaluation of sensitivity of reproductive organs of offspring were discussed: PMRA did not concur with EPA's conclusion that offspring do not appear to show increased sensitivity to testicular effects.

Agency response: EPA agrees with PMRA that many of the studies on boric acid/ sodium borate were not performed to current standards. In considering the entire database, EPA determined that a reasonable assessment of toxicity could be conducted for regulatory purposes using this data, despite the inadequacies in these studies. Many were classified as nonguideline/ acceptable, using the current HED study acceptability nomenclature, to indicate that although the studies did not meet guideline standards, there was sufficient data to provide a reasonable hazard characterization for use in risk assessment. In lieu of requesting additional data, which the Agency does not consider likely to provide a lower endpoint value ( although new studies would, of course, be useful to establish certain NOAELs/ LOAELs in these studies), an endpoint was selected ( 8.8 mg/ kg/ day in the dog) that is considered reasonable for assessment of risk. EPA identified different NOAELs/ LOAELs than PMRA for some of the studies, for example, based on lack of a clear dose response or different interpretation of other findings in the study reports.

EPA concurs with PMRA that there were significant deficiencies in the rat reproductive toxicity studies. However, new studies, which may provide important information regarding offspring and parental reproductive effects and relative sensitivities of males and females, are unlikely to identify a significantly lower endpoint compared to the current dog endpoint used in this assessment. EPA considers the mouse study by NTP, which included crossover mating evaluations, supportive of lack of a significantly increased risk to offspring based on lack of a lower reproductive LOAEL for the later generations. Additionally, the NOAEL for all generations is approximately 2.5 fold higher than the dog endpoint. Within the context of the data limitations outlined by PMRA, the data support lack of significantly increased risk to offspring.

8. Comment increased fetal sensitivity in rabbit: PMRA considered agenesis of the gallbladder, seen in the developmental toxicity study on rabbits, to be a treatment related effect and determined that increased fetal sensitivity was observed, based on this finding at a dose below the maternally toxic dose. In the review of this study, HED did not consider this effect to be treatment related. Page 6 of 20 Agency response: HED has revisited this study, conducted by NTP. Doses tested were 0, 62.5, 125 or 250 mg/ kg/ day boric acid. Agenesis of the gall bladder was not observed in control or low dose fetuses but was seen in 3/ 153 fetuses ( 20 litters examined) at the mid dose and 2/ 14 fetuses at high dose ( 6 litters examined). The incidence can be considered to be increased at high dose, while at mid dose, the increase is marginal. Other malformations were observed at the high dose in this study. The study authors noted the gallbladder effects as " potentially" related to boric acid treatment, but did not use this finding to establish a developmental LOAEL, stating that " No definitive evidence of developmental toxicity was observed at 125 mg/ kg/ day. The low dose ( 62 mg/ kg/ day) was clearly nontoxic to both the maternal animal and the developing conceptus. Thus, the maternal and developmental NOAELs were considered to be 125 mg/ kg/ day."

Agenesis of the gallbladder in rabbits is a relatively uncommon malformation in rabbit, but is occasionally observed in untreated animals. At this time, the Agency will retain the developmental toxicity NOAEL at the mid dose, but will note the finding in the study summary.

9. Comment cancer classification: PMRA disagreed with the classification of boric acid/ sodium borates as " not likely to be carcinogenic to humans" and supported the classification of " inadequate information for classification of carcinogenicity to humans" based on study inadequacy. PMRA noted that the rat studies by Hazleton Laboratories on boric acid and borax did not contain a complete tissue evaluation and did not provide a tabulated evaluation of neoplastic findings and the mouse National Toxicology Program ( NTP) study tested two dose levels and showed increased mortality in males in the treated groups. In addition, the US EPA IRIS review of boron in 2004 also considered the data inadequate to make a determination.

Agency response: In assessing whether boric acid/ sodium borates were likely to be carcinogenic to humans, HED made a weight of the evidence determination based on the available carcinogenicity data in experimental animals ( the NTP mouse study and 2 year dietary studies on boric acid and sodium metaborate in the rat by Hazleton Laboratories), together with other information, such as genotoxicity data and human exposure. HED considered the NTP mouse study adequate for evaluation of carcinogenicity. Although only two test levels were conducted, toxicity was sufficient to achieve the MTD and HED did not consider the increased mortality in treated males to be of sufficient magnitude to affect conclusions. NTP concluded that there was no evidence of carcinogenicity to mice in this study.

While the rat studies on boric acid and borax were not performed to standard carcinogenicity testing guidelines, both studies did examine most tissues typically evaluated in a cancer study. The NTP, in deciding to test only mice, also made the determination that rats had already been adequately tested in that study. There is no evidence that boron has genotoxic potential and boron is rapidly excreted following ingestion. Human epidemiology data are limited, but the constant exposure via diet and drinking water to this naturally occurring element with no evidence of an increase in the incidence of neoplasia suggests that boron is not likely to be a carcinogen to humans or to other species.

10. Comment characterization of hematological findings: US Borax considered decreases in red blood cell parameters noted as anemia in some studies to be subclinical and possibly Page 7 of 20 secondary to other toxicity. Standardization of terminology throughout the TRED was requested ( referred to in different parts of the document as " anemia," " slight anemia" or " mild anemia").

Agency response: Terminology for the effects on red blood cells has been changed to either " slight hematological changes" or a description of the affected parameters. The Agency generally considers reductions exceeding 10% in red blood cell parameters to be potentially adverse. Effects on red blood cell parameters were identified at dose levels showing other, more significant effects and by themselves were not used to determine study LOAELs.

11. Comment rat maternal toxicity LOAEL selection: PMRA noted that one of the rat developmental toxicity studies identified the maternal toxicity LOAEL based on decreased gravid weight, which was probably due to fetal loss.

Agency response: EPA concurs with PMRA and the maternal LOAEL has been changed to a NOAEL.

12. Comment need for repeat exposure inhalation toxicity study: US Borax questioned the need for a 28 day inhalation toxicity study. They cited acute inhalation studies ( MRIDs 43500701, 44383601) showing that boric acid was in toxicity category III rather than II ( highest dose tested was 2000 mg/ L, the limit dose).

Agency response: HED has reconsidered this data requirement. At this time, a 28 day inhalation toxicity study in the rat will not be required, based on consideration of the Registrant's comments, and will retain use of an oral study for inhalation exposure risk assessment. However, should new uses and/ or other inhalation epidemiologic, experimental or incident data suggest that additional inhalation toxicity data is needed to better assess hazard from inhalation exposure, this study requirement may then be reconsidered.

13. Comment upgrade of UDS study: US Borax submitted experimental data in support of the unscheduled DNA synthesis study ( MRID 42038903) to upgrade it to Guideline Acceptable.

Agency response: HED has reviewed the submitted information and has upgraded the study to acceptable. A new study is not required.

14. Comment relevancy of HOX gene alterations to humans: US Borax did not consider alteration of the HOX gene in published rodent developmental toxicity studies to be relevant to human risk assessment based on observation of the effect at high dose levels ( 500 mg/ kg/ day).

Agency response: The effect of boric acid on HOX gene expression during development was not evaluated for dose response and lower dose levels were not evaluated. The LOAEL and NOAEL for this finding are therefore not known at this time. HED will add a statement to the TRED noting this fact.

15. Comment characterization of endocrine disruptor potential: US Borax and PMRA do not consider boric acid/ sodium borates to have the potential to disrupt the endocrine system. US Page 8 of 20 Borax noted lack of epidemiological support for this effect; both US Borax and PMRA noted published data suggesting lack of endocrine disruption as the mechanism of testicular toxicity and inhibited spermiation ( Fail et al., 1998).

Agency response: The current language on endocrine disruption will be retained due to lack of conclusive data regarding effects on endocrine hormones. Although the Fail et al. paper suggests that the testicular hormonal effects in male rats are secondary to cytotoxicity, this mechanism has not been established and there is also no data on other endocrine hormones, e. g., estrogens. This section is intended to reflect uncertainties in the available information, rather than to suggest that boron is an endocrine disruptor.

16. Comment vomiting in acute oral study in dog: US Borax noted that for the acute oral toxicity study in the dog ( MRID 40692304), it should be noted that dosing in dogs appears to be limited by vomiting at higher dose levels.

Agency response: HED has noted this in the TRED document.

17. Comment dermal irritation of sodium metaborate: US Borax requested that in Section <IP_ADDRESS> of the TRED document, it should be noted that sodium metaborate, but not boric acid or other sodium borate salts, is a dermal irritant.

Agency response: HED has made this change in the TRED document.

18. Comment additional boron dietary intake values: US Borax requested consideration of a reference by Rainey et al. ( 1999) regarding daily boron intake in the United States.

Agency response: HED has reviewed this article and provided values for boron intake from the article in Section 3.2 of the TRED document.

19. Comment correction of boron equivalent calculations: PMRA noted corrections to be made in the boron equivalent calculations in the mouse carcinogenicity study on boric acid and chronic rat study on borax.

Agency response: EPA has made corrections as appropriate.

COMMENTS ON THE EXPOSURE ASSESSMENT Comments on the exposure assessment for this tolerance reassessment were received by US Borax, Nisus, MeadWestvaco, Searles Valley Minerals, Industrial Minerals Association, Biolab, Inc., National Pest Management Association, McIntyre Associates, Cole Research and Development and Canadian PMRA.

1. PMRA Comment: 9444 150 ( aerosol cans): The density was used to convert 14 ounces to pounds ai, assuming fluid ounces. However, based on the product label, the can appears to be Page 9 of 20 14 ounces ( mass), 397 g ( i. e., unit of mass not volume). Based on conversions of ounces ( mass), 397 g product * 20% * 79.4 g ai use per day of 0.17 lb ai, rather than 0.27 lb ai.

Agency Response: The Agency agrees and will make the appropriate changes to the TRED. It should be noted that the source document for the TRED ( Exposure and Risk Assessment on Lower Risk Pesticide Chemicals, Boric Acid and its Sodium Salts) will also need to be corrected.

2. PMRA Comment: In the Exposure Table of Appendix 3, the source of the inhalation unit exposure value is not clear. The PHED aerosol inhalation unit exposure value of 1300 µ g/ lb ai was not used. The source of the value of 2400 µ g/ lb ai handled should be indicated.

Agency Response: The PHED value of 1300 µ g/ lb ai handled is an occupational inhalation PHED value while the residential value ( also from PHED) of 2400 µ g/ lb ai is from the aerosol spray subset.

3. PMRA Comment: 70908 3 and 48369 2 ( dust via shaker can): the source of the inhalation unit exposure value for shaker can ( value 870 µ g/ lb ai) which is found in the Exposure Table of Appendix 3.0 should be presented. A default approach for shaker can scenarios may involve assuming a percentage of total amounts applied ( as outlined in the Residential SOPs), however, it appears that other data were used in this assessment.

Agency Response: A unit exposure value was taken from a proprietary study ( applying dusts with a shaker can) and will be identified in the revised TRED. The study is Merricks, D. Larry ( 2001) Determination of Dermal ( hands and forearms) and Inhalation Exposure to Disulfoton Resulting from Residential Applications of Bayer Advanced Garden 2 in 1 Systemic Rose and Flower Care to Shrubs. MRID 45333401 February 8, 2001.

4. PMRA Comment: 1677 191 ( granular bait dispersed by hand): The density was used to convert ounces to a mass of product applied, however, the product label indicates that the product is " 12 ounces of 340 g." At ½ a can ( or 170 g), the amount handled per day is 170 g * 54% = 91.8 g or 0.202 lb ai.

Agency Response: The Agency agrees and will make the appropriate changes to the TRED. It should be noted that the source document for the TRED ( Exposure and Risk Assessment on Lower Risk Pesticide Chemicals, Boric Acid and its Sodium Salts) will also need to be corrected.

5. PMRA Comment: 5185 461 ( m/ l granular via spoon of cup): The source of the inhalation unit exposure value is not clear. In the Exposure Table of Appendix 3.0, it is cited as 45 µ g/ lb ai, whereas in PHED surrogate tables for granular open mixing/ loading, inhalation unit exposure value is 1.7 µ g/ lb ai.

Agency Response: The 1.7 value is for occupational assessments. The Agency relied on a proprietary study to assess the residential use of applying a granular via spoon or cup. The study used was: Fipronil, Worker Exposure Study During Application of Regent 20GR in Banana Plantation. [ MRID 452507 02]', P. Pontal, 1996. The TRED will be revised to include this citation. Page 10 of 20 6. PMRA Comment: 1083 1, 64405 6, 79628 1 ( trigger pump sprayer): Source of inhalation unit exposure value for trigger pump sprayer on Table 3.0, page 71, is not clear.

Agency Response: The Agency has relied on a proprietary study to assess this use. The study, Carbaryl Mixer/ Loader/ Applicator Exposure Study During Application of RP 2 Liquid ( 21%), Sevin Ready to Use Insect Spray or Sevin 10 Dust to Home Garden Vegetables. MRID 444598 01 D. Merricks. ( 1997). The TRED will be revised to include this citation.

7. PMRA Comment: Product 79628 1 is a wood preservative product in which pretreatment may take place to wood foam composite structural components as such, it is not anticipated that a trigger sprayer is a representative application method. PMRA also noted this product contains 99.98% active ingredient Agency Response: The Agency agrees and will remove the scenario from the revised assessment.

8. PMRA Comment: 71635 5 ( m/ l/ a with paint brush): The label for this product ( a wood preservative) indicates that it may also be applied by spray application however this application wasn't included for this product.

Agency Response: Paint brush scenario results in higher exposures and lower MOEs. Because the MOE for the paint brush scenario was greater than 100,000, the other scenario was not included.

9. PMRA Comment: Inputs of 1hour/ event ( adult and 2 hours/ event ( child)) are not consistent with the Residential SOP 90th percentile value ( 5 hours/ event for both children and adults) It was noted that the Swimmodel inputs in the TRED that 1 hr/ event was a 90th percentile value.

Agency Response: The draft Children's Specific Exposure Factors Handbook recommends an exposure duration of 60 minutes per event ( based on one event per month) for contact with water while swimming. This value is described as " upper" while a 0.5 hours per event was described as " central". These values are for people responding to the NHAPS Survey question " in the past month, did you swim in a freshwater pool?".

10. PMRA Comment: The contact rate ( water ingested) of 2.5E 2 L/ hr ( adults) is not consistent with the Residential SOP; Residential SOP recommends 0.05 L/ hr for both adults and children. Clarification of the source of the alternative value for adults is recommended. Page 11 of 20 Agency Response: The following input values are in the current SWIMODEL:

Ingestion rate ( mL/ hr) Competitive Non competitive Child ( 7 10 years) 25 ( 1/ 2 the rate for noncompetitive swimmers, as recommended by the American Chemistry Council ( ACC), 2002) 50 EPA, 1989 and 1997; ACC, 2002 based on an EPA pilot study)

Child ( 11 14) 25 ( 1/ 2 the rate for noncompetitive swimmers, as recommended by the ACC, 2002) 50 EPA, 1989 and 1997; ACC, 2002 based on an EPA pilot study)

Adults 12.5 ( 1/ 2 the rate used for non competitive swimmers as recommended by ACC, 2002) 25 ( ACC, 2002   based on EPA pilot study)

11. PMRA Comment: Inhalation rate for adults for moderate activity is 1.6 m3/ hr, based on revisions to the Residential SOPs ( Feb, 2001); 1.0 m3/ hr was used for adults in the TRED.

Agency Response: It was assumed that the use of boric acid as an algaecide was primarily intended for residential swimming pools. The following table presents the inhalation rates in the current version of the SWIMODEL:

Inhalation rate ( m3/ hr) Competitive Non competitive Child ( 7 10 years) 1.9 ( Table 5 23 of the Exposure Factors Handbook ( EFH); short term exposures, heavy activity) 1.0 ( Table 5 23 of EHF; short term exposures, light activity)

Child ( 11 14) 1.9 ( Table 5 23 of the EFH; short term exposures, heavy activity ) 1.0 ( Table 5 23 of EFH: short term exposures, light activity)

Adults 3.2 ( Table 5 23 of the EFH: short term exposures, heavy duty) 1.0 ( Table 5 23 of EHF; short term exposures, light activity) Page 12 of 20 Given the low vapor pressure of Boric Acid compounds ( as pointed out by other commenters), the Agency did not include the inhalation route for this scenario in the revised TRED.

12. PMRA Comment: The 90th percentile for body weight was used for the swimming assessments; it would be useful to identify why a 90th percentile was chosen for this parameter.

Agency Response: In the revised TRED a body weight of 70 kg will be used for males/ females.

13. PMRA Comment: Child physiology values ( inhalation and body weight) are based on child aged 7 10 or 11 14. It is recommended to include an assessment of a child aged 6 to determine the risk associated with this age group or lower, as lower body rates and similar water ingestion rates are anticipated to result in low MOEs.

Agency Response: The actual SWIMODEL does not include a default for children aged 6 years or younger. However, since a dermal assessment is not needed and inhalation MOEs are sufficiently high ( range) the resultant risk estimates are unlikely to be significantly different. For inhalation in particular since these compounds have low vapor pressures.

14. PMRA Comment: The water concentration for spa appears to be higher than that of a pool. An assessment for a spa may be warranted due to differences in concentration ( inputs such as water ingestion and time spent may be justified to be different between spas and pools) or a justification for not including this scenario should be provided.

Agency Response: A maximum application rate of 0.0045 lb ai/ gal is applied to pools ( label 5185 461) and a maximum application rate of 0.0031 lb ai/ gal is made to spas ( label 5185 492). HED believes there is less potential for swimming ( and subsequent ingestion of water) for the spa scenario. Its inclusion does not appear to be justified at this time.

15. PMRA Comment: In the case of the boric acid inert, the source of the value for chemical concentration of boric acid in water was not clear.

Agency Response: It was assumed that the concentrations for the inert products were 1% of the application rate for boric acid when used as an algaecide. We note an error in Table 6.3c indicating a water concentration of 54,000 µ g/ L. The value should be 540,000 µ g/ L. The latter value was used as an input value to the SWIMODEL. Therefore, the exposure calculations are correct ( likewise, the inert source should be 5,380 µ g/ L).

16. PMRA Comment: It is difficult to match the scenarios and use rates presented in Table 6.3d with the application scenarios under Table 63a, as the references to product labels are not listed as in Table 6.3a.

It appears that the use rates used in this post application assessment reflect rates examined in the applicator assessment. It was not clear whether other products, used by commercial applicators, may result in high use rates per unit area and possibly result in higher post application exposure potential. Page 13 of 20 Agency Response: It is believed that exemplary labels representing all uses were presented in the document.

17. PMRA Comment: Based on comments on application rate in the handler exposure assessment ( i. e. application rate calculations base on ounces in mass rather than volume), the application rate used in the children's exposure assessment for the aerosol application and the granular bait dispersed by hand may be different.

It appears that the application rate for the first carpet spray for disodium octaborate tetrahydrate ( based on 64405) should be 0.003 lb ai/ ft2 rather than 0.0003 lb ai/ ft2, based on the following equation:

1 gallon/ 750 ft2 * 0.32 g/ mL * 1000 mL/ L * 3.78 L/ gallon * 2.2 lb/ kg * 1 kg/ 1000 g = 0.0035 ft2 Agency Response: The above equation does not take into account the percent active ingredient ( 8.5%).

18. PMRA Comment: Footnote c is missing in the table; it appears that footnote e should be footnote d and footnote in the table should be c.

Agency Response: The Agency agrees with this comment and will make the corrections.

19. PMRA Comment: The scenarios under disodium octaborate and disodium octaborate tetrahydrate scenarios are confusing as they are identified as a spray carpet scenario, however, these products ( 71653 5, 79629 1) are wood preservation products. These scenarios should be clarified and the applicability/ uncertainty associated with the inputs derived from carpet/ hard surface scenarios should be describe ( this may be corrected in the memo specific to wood preservation uses).

Agency Response: The post application assessment for disodium octaborate tetrahydrate is for product 64405 6 ( carpet treatment). When the TRED and source document were prepared, the post application exposure potential for exposure to the wood preservative products appeared to be low. Although the labels suggest that the types of materials to be treated are for interior construction such as framing and siding materials, there is a possibility that some of these products may end up being used in decking.

20. PMRA Comment: The handler exposure and risk calculation only examines one product ( 72468 2). Based on the labels cited in the HED chapter, other wood preservative products were assessed however these products were not discussed in the supplementary memo ( i. e. products 71653 5, 79628 1). It is not clear whether the product which is presented in this supplementary assessment is representative of all other wood preservative labels ( e. g. has highest rate per unit area of application). Based on the label, it appears possible that this product may be applied by methods other than low pressure spray ( for example it appears that paintbrush may be another method of application), alternative methods of application could also be considered. Page 14 of 20 Only product 72468 2 was included in this toddler post application assessment, with only one rate being examined ( the label appears to be ambiguous about rates for various methods of treatment). It is not clear if this assessment is to be representative of all other wood preservative products containing boron.

The toddler post application assessment only assesses exposure associated with consumer application of boron products. Several of the products identified in the assessment ( including 72468 2, 79628 1 and 71653 5) include pressure treatment uses, which are not relevant for the residential handler exposure assessment, but may result in residential post application exposure. It is not clear if the assessment which is presented is lonely meant to cover spray/ surface applications or if it is meant to address pressure treatment applications. If it is meant to address pressure treatment applications, further discussions of the uncertainties associated with extrapolating exposure from a surface application rate to a product which penetrates the wood is required.

Agency Response: The post application assessment of wood treatments was not conducted in the source document for the TRED ( Exposure and Risk Assessment on Lower Risk Pesticide Chemicals, Boric Acid and its Sodium Salts). This oversight was not identified until late in the TRED process. In the revised TRED, the worst case scenario ( in situ deck treatment) will be used to assess both pressure treated lumber and decks. It is believed that data already generated by the registrants can be used to refine these scenarios. These data will need to be submitted and reviewed.

21. Industry Minerals Association   North America; U. S. Borax Inc.; Nisus Corporation Comment: Carpet Crack and Crevice Assessment The assessments for carpet applications must be distinguished from crack and crevice applications. This is necessary because the methods of use ( and resulting exposure) differ significantly. The different methods of use are incorporated into the official pesticide registration and the required labels. The risk assessments should be based on the labels as currently registered and should consider the label instructions.

Regarding carpet applications, we agree that there are insufficient data to properly characterize exposures. In the absence of data, we agree that conservative assumptions should be utilized. The request for data on carpet/ hand transfer in Section 10.3 should be helpful in reducing uncertainties.

Regarding crack and crevice applications, we do not agree that the resulting exposure is excessive or that additional data would be useful to reduce uncertainties. The assessment should be revised to reflect the following issues:

  Crack and crevice applications are not broadcast over large surface areas;   Labels for crack and crevice treatment clearly indicate removal of all visible product by brushing into cracks or sweeping up;   Additionally, the application rates used for estimating crack and crevice exposure are based on rate and methods for carpet application ( lbs/ sf);   Data from carpet/ hand transfers would not clarify crack and crevice exposures; and Page 15 of 20   Two of the labels referenced in the carpet/ crack and crevice risk assessment are inappropriate for consideration.

Based on the label instruction for crack and crevice applications as currently required by EPA, exposure to boron is mitigated by removal of all visible product. Additionally, label instruction to limit application to areas which are inaccessible to children and pets further mitigates exposure concerns. Consideration of these factors would result in a more accurate assessment of exposure to boron from crack and crevice applications.

Agency Response: See response to Comment # 22 below.

22. U. S. Borax Inc. Comment: U. S. Borax provided comments similar to those provided by IMA NA. However, U. S. Borax noted that label directions instruct users of crack and crevice products to " not apply in living spaces accessible to children and pets." They assert that this language was imposed by the 1993 Boric Acid RED and as such would result in minimal amounts of product to be available for exposure to animals or pets.

Agency Response: The Agency believes that a simple study can be conducted to address both broadcast and crack and crevice applications. Crack and crevice applications result in deposition patterns ranging from high ( e. g., along baseboards) to low ( center of the room). Thus, a young child has the potential to come in contact with both concentrations. Hand removal efficiency data in the form a wipe or hand press study would be very helpful to refine both scenarios. HED believes that label language directing the user to remove visible residues ( e. g. brushing into cracks or sweeping up) will reduce but not eliminate residues ( likewise common sense language to apply the product to areas inaccessible to children and pets). At a minimum, surface wipe and or hand press ( cotton gloves over latex) residue study based on compliance with broadcast and crack and crevice label directions should be sufficient to address both uses.

23. Industry Minerals Association   North America Comment: The risk assessment should distinguish between the application of a ready to use solution by brush or spray to decks in situ ( which is the scenario addressed by the TRED assessment) and pressure impregnation treatments of dimensional lumber done by producers of treated wood. Lumber treatment is carried out at specifically designed facilities with pressure chambers that directly drive the preservative into the wood using conditions of temperature, pressure and vacuum. This different mode of treatment limits the amount of surface residues available for potential exposure. A simple acknowledgement that the TRED scenario addresses the application of ready to use solutions but not the commercial pressure impregnation treatment scenario would help avoid confusion about the scope of the assessment.

The assessment should be revised to reflect the following issues:   Dislodgability (%) of the active ingredient from the deck surface;   Penetration of the preservative into wood;   Sealant mitigation of exposure; and   Calculation of toddler exposure from sprayed decks. Page 16 of 20 Based on the label instruction exposure to boron is mitigated by absorption into the wood and, as indicated by EPA, sealing the wood. Consideration of these factors would result in a more accurate assessment of exposure to boron from disodium octaborate tetrahydrate treated wood by spray application.

Agency Response: A post application assessment was not conducted for the wood treatment products in either the Exposure and Risk Assessment on Lower Risk Pesticide Chemicals  Boric Acid and its Sodium Salts or the TRED. This oversight was not identified until late in the TRED process and addressed minimally in a follow up memorandum dated January 6, 2006. When post application data addressing non dietary ingestion pathways ( for both the pressure treated and in situ wood treatments) are submitted, these scenarios can then be refined.

Regarding the presumption that sealants mitigate exposure potential, HED has recently learned from the Antimicrobials Division that they are not considering the impact of coatings/ sealants in wood treatment risk assessments. It is believed that the wipe data presented by various commenters would be helpful in addressing these exposure scenarios. We encourage that these or other similar data be submitted.

24. Industrial Minerals Association   North American Comment: The assessment of swimming pool applications should be revised to reflect appropriate use of the residential postapplication exposure model, concentrations of active ingredients and relevant acute end points.

The assessment should be revised to reflect the following issues:   Description of products and application methods;   Dermal and inhalation pathways   MOE Calculation based on potential dose rate ( PDR) vs. average daily dose ( ADD).

The application rate input into the model ( 5,400,000 µ g/ liter) is off by a factor of 10, one decimal place. This computational error increases the margin of exposure ( MOE) to an acceptable level. The TRED assessment should acknowledge that the calculations are based on maximal conditions   100% active with the highest application rate, and therefore incorporates a conservative approach to the estimated risk. Appendix 6.0 for the exposure scenario for swimmers should not include the dermal and inhalation pathways. Recalculation of the ADD demonstrates the MOE for this broadcast application of sodium tetraborate pentahydrate ( 100% a. i.) using conservative Tier 1 based exposure screening tool ( SWIMODEL) is well above the minimum value of 100 in the TRED.

Agency Response: The application input to the SWIMODEL was 5.4 E+ 05 and was further adjusted by percent boron in the label specific active ingredient statement ( 14.85% boron in sodium tetraborate pentahydrate) in Table 6.3c. We previously noted the typographical error in Table 6.3c indicating a concentration of 54,000 µ g/ L.

A non dietary ingestion endpoint was selected for short term exposure ( 1 to 30 days). Therefore a single day exposure ( the PDR) must be used in lieu of the amortized value ( ADD) generated by the SWIMODEL. Page 17 of 20 25. MeadWestvaco Comment: The commenter submitted measurements of boron in/ on lumber ( yellow pine deck boards) pressure treated with a boric acid compound. These measurements coupled with the exposure assumptions presented in the addendum to the Boric Acid TRED indicate Margins of Exposure ( MOE) above 100 for post application exposure.

Surface Boron Concentrations and Margin of Exposure for Toddlers Measurement units Protected Boards 5 Month Weathered Boards Mass concentration1, ppb B 4,960 450 Surface conc. 2 µ g B/ sq ft 10,340 940 MOE3, dimensionless 580 6,400 1. Inductively coupled plasma ( ICP) analysis of a thin ( 1/ 16 in) slice of wood from upper surface; 2. One fiber diameter depth ( 40 µ m) and density of treated wood ( 35/ ft2) used in calculations; 3. Margin of Exposure for Toddler Non Dietary Ingestion using EPA estimation method reported in their 25Jan06 document " supplement to HED Chapter " which uses a 10% dislodgeable estimate.

The commenters acknowledge the lack of data available to address the pressure treated wood uses and in situ wood surface treatments. In the table shown above, they assert that MOEs greater than 100 can be achieved if the Agency relies on the surface concentration measurements indicated by footnote two, and the 10 percent dislodgeable estimate used in the TRED ( indicated by footnote three).

In a separate letter dated April 21, 2006, MeadWestvaco indicated non dietary ingestion MOEs ranging from ~ 5800 to 210,000 for exposure to pressure treated lumber when relying on data presented in J. D. Lloyd's hand press study ( 1996).

Agency Response: The Agency welcomes the opportunity to review the data, however we note that both the data addressing the pressure treated wood and the in situ treatments are only presented in the comments in summary form. Both studies need to be submitted for review. In addition, the dislodgeable data discussed in J. D. Lloyd's paper will need to undergo a human subject's review. The study is reportedly based on a study involving intentional human exposure ( bare hand press) to solutions containing and wood treated with a boric acid compound. The Agency will use dislodgeable estimates presented in the aforementioned studies and will consider the submissions as confirmatory.

26. U. S. Borax Inc.; Searles Valley Minerals Comment: The U. S. Borax Corporation provided information commonly understood in the wood preservative industry regarding the American Wood Preservers' Association ( AWPA) penetration standards for aqueous based or waterborne preservatives. For disodium octaborate tetrahydrate ( DOT) uses ( Formosan and non Formosan species of termites), the registrant asserts that retention depths of 0.4 inches ( non Formosan) and 0.6 inches ( Formosan), coupled with chemical retentions ( lbs/ ft3) are required. These retentions are 0.25 ( non Formosan) and 0.43 ( Formosan) when in accordance with the Page 18 of 20 AWPA standard. By using the minimum retention standard and the calculations presented in the TRED ( in situ) the commenters estimate that 75% of the amount applied is available on the surface ( rather than the 100% assumed in the TRED).

The U. S. Borax Corporation and Searles Valley Minerals also had issue with HED's statements regarding the effectiveness of wood sealants. They note that two contradictory statements regarding wood sealing were made:

In the exposure section; " the extent to which this sealing mitigates boron transfer to children's hands is unknown at this time"; and On Page 2 of the TRED " painting lumber is likely to mitigate exposure to borate products in treated wood."

Agency Response: The Agency will consider using the 25% reduction in surface availability based on the commenter's understanding of the penetration of topical wood treatments. The Agency also recognizes that sealing may impact the surface availability of the substance used to treat the wood. However at the time those statements were made, HED was not aware of any information or data demonstrating the impact of sealing. This uncertainty was captured in the two statements quoted by the commenter. Whether the two statements are contradictory to us seems to be a matter of judgment, however we regret any misunderstanding. More importantly, HED has learned that the Agency's Antimicrobial Division does not accept sealing as a means to mitigate exposure in risk assessments.

27. U. S. Borax Inc. Comment: The registrant recalculated non dietary ingestion risks using 75 percent surface availability, and the percent dislodgeablility values presented in J. Lloyd, 1996. Margins of exposure based on wet hand dislodgability and dry hand dislodgeablilty are 177 and 591 respectively.

Agency Response: The Agency will revise the assessment to include the 75 percent surface availability. Additional refinement will be made after the data are submitted and reviewed. These data will need to be formally submitted.

28. U. S. Borax Inc.; BioLab, Inc. Comment:

The registrants recalculated swimmer ingestion rates for children by using the SWIMODEL ADD estimates rather than the SWIMODEL PDR estimates used in the TRED. The PDR values are daily exposure estimates. The ADD estimates are amortized values based on number of days swimming per year times the number of years swimming divided by 365 days a year. They also assert that estimates of exposure for inhalation and dermal routes should not be made due to the low vapor pressure and low dermal absorption rate respectively. They present a number of MOE estimates for three different pool water concentrations. By using ADD estimates from the SWIMODEL and the different concentrations, MOEs ranged from ~ 1700 to 6200.

Agency Response: The Health Effects Division ( HED) uses PDR or daily exposure estimates when comparing exposure to short term endpoints ( 1 to 30 days). In the toxicology chapter the Page 19 of 20 toxicity study was determined to be appropriate for assessing short term exposures. Therefore HED will continue using the PDR instead of the ADD.

Dermal exposure was not assessed in the TRED although these estimates were displayed in the SWIMODEL output files. HED is reconsidering its decision to include the inhalation route in the revised assessment. However we note that the risk assessment showed these exposures to be of low concern.

HED will recalculate the non dietary ingestion values for other pool concentrations indicated by the commenters. It should be noted that we will be using standard body weights ( e. g., 70 kg for adults) will result in slightly higher PDRs.

29. U. S. Borax Inc.; BioLab, Inc.; Nisus Corporation; Comment: The commenters note that other registered products having lower percentages of Boron and recommendations for lower application rates were not show in the TRED. They assert that those shown represent the highest potential for incidental oral ingestion from swimming pool uses.

Agency Response: The source document for the Boric Acid TRED was ( Exposure and Risk Assessment on Lower Risk Pesticide Chemicals  Boric Acid and its Sodium Salts) originally meant to be a screening level assessment focusing on products having higher rates of exposure. Conceptually, if estimates of exposure from high application rates were determined to be of no or low concern, logic would suggest that exposure estimates for the lower rates would also be of no or low concern. Inert uses were estimated to be one percent of the high percentage active ingredient uses. The inert uses showed exposures of no or low concern. Since exposures of concern have been identified for products having high application rates, lower application rates will also be evaluated.

30. McIntyre Associates, Inc. Comment: Data exist in Agency files that would allow the amount of surface residues from the pressure treated borate systems to be approximated by consideration of the amount of residues from an analogous system. For example, wood pressure treated with CCA would be considered analogous to wood pressure treated with DOT both preservative formulations would be deeply impregnated into the wood and the actual surfaces would not have a significantly higher concentration of chemicals. In a review1 of wipe tests, data from 348 wipe samples from wood treated to a 0.40 pcf retention material with CCA had a mean value of 0.356 µ g/ cm2 of chrome. This is 331 µ g per square foot.

The amount of elemental chrome in 0.40 pounds of CCA is 0.099 pounds while the amount of elemental boron in 28 pounds of B2O3 is 0.087 pounds. Thus, one would expect that the amount of surface residue from wood pressure treated with borates would also be around 300 µ g per square foot.

As shown, the approximate amount of surface residue expected based on analogous science ( 300 µ g/ sf) is very small compared to the 462,470 µ g/ sf calculated by the topically applied route. In fact, it is 0.065% and a corresponding reduction in the ADD results in a MOE of over 20,000. This is well beyond the MOE of 100 required for residential exposure. Page 20 of 20 It should be noted that the surface residue data came from an Agency report and that the values chosen were the highest surface residues in that report. The data came from unsealed material and other data showed that various coatings significantly reduced the surface residues. Therefore, it seems reasonable to believe that this analogous method would represent a worst case scenario.

Agency Response: The exposure scenarios for wood treatment products were not identified until late in the TRED process. We agree to evaluate both pressure and in situ wood treatment uses in the revision.

In general, HED prefers chemical specific data The Antimicrobials Division was responsible for the CCA treated wood assessment and HED will defer to that division whether the wipe data for CCA. They do not rely on the CCA data for use ( generically) for other wood treatment chemicals. We note that other commenters including Dr. McIntyre suggest the Agency rely on boron levels in surface wafers cut from treated boards that were presented in several other TRED comment packages. The Agency agrees to consider these surface wafer data.

31. Nisus Corporation Comment: Nisus suggests a review of available data and draws the Agency's attention to Study Title: Evaluation of Human Exposure Potential of Boric Acid Carpet Treatment for Fleas ( 48 p.) DPR Study ID Number: 143425 Laboratory: University of California, Riverside Dept. of Entomology Report Date: 11/ 01/ 1995 Received at DPR: 12/ 27/ 1995. They suggest that a risk assessment on this type of application would be similar for wood treatments. They assert that although reviewers are seeking data to support the safety of each application, it is important that safe methods ( such as using Boric Acid products) are not eliminated based on assumptions of misuse and where modified labeling provides reduced exposure.

Agency Response: The Agency is in contact with the California Department of Pesticide Regulation ( DPR) regarding the above referenced assessment. According to DPR, the study is proprietary. However, we note that the assessment is likely to be based on similar study design as the draft study referenced in the TRED   Human Disodium Octaborate Tehrahydrate Exposure Following Carpet Flea Treatment is Not Associated with Significant Dermal Absorption. At the time the TRED was being prepared, a draft of the study was in our possession. Recently, one of the authors has provided a copy of the study as presented in the Journal of Exposure Analysis and Environmental Epidemiology, Vol. 6, No. 3, 1996. In the study report are discussions of the transfer of DOT residues. These kinds of measurements are useful for dermal exposure; however for non dietary ingestion assessments, these types of data require adjustment for the increased transfer efficiency due to wet hands. In addition, the study does not address the powder/ dust formulations. The Agency is confident this data gap will be easily fulfilled.


[Federal Register Volume 85, Number 227 (Tuesday, November 24, 2020)]
[Notices]
[Page 75008]
[FR Doc No: 2020-25929]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. EL21-5-000]

Lone Tree Wind, LLC; Notice of Institution of Section 206
Proceeding and Refund Effective Date

    On November 17, 2020, the Commission issued an order in Docket No.
EL21-5-000, pursuant to section 206 of the Federal Power Act (FPA), 16
U.S.C. 824e (2018), instituting an investigation into whether Lone Tree
Wind, LLC's proposed Rate Schedule may be unjust, unreasonable, unduly
discriminatory or preferential, or otherwise unlawful. Lone Tree Wind,
LLC, 173 FERC 61,144 (2020).
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pursuant to section 206(b) of the FPA, will be the date of publication
of this notice in the Federal Register.
    Any interested person desiring to be heard in Docket No. EL21-5-000
must file a notice of intervention or motion to intervene, as
appropriate, with the Federal Energy Regulatory Commission, 888 First
Street NE, Washington, DC 20426, in accordance with Rule 214 of the
Commission's Rules of Practice and Procedure, 18 CFR 385.214 (2020),
within 21 days of the date of issuance of the order.
    In addition to publishing the full text of this document in the
Federal Register, the Commission provides all interested persons an
opportunity to view and/or print the contents of this document via the
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the eLibrary link. Enter the docket number excluding the last three
digits in the docket number field to access the document. At this time,
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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 at
<EMAIL_ADDRESS>or call toll-free,<PHONE_NUMBER> or TYY,
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paper copy. Submissions sent via the U.S. Postal Service must be
addressed to: Kimberly D. Bose, Secretary, Federal Energy Regulatory
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Submissions sent via any other carrier must be addressed to: Kimberly
D. Bose, Secretary, Federal Energy Regulatory Commission, 12225 Wilkins
Avenue, Rockville, Maryland 20852.

    Dated: November 18, 2020.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2020-25929 Filed 11-23-20; 8:45 am]
BILLING CODE 6717-01-P