[Federal Register Volume 77, Number 76 (Thursday, April 19, 2012)]
[Notices]
[Page 23471]
[FR Doc No: 2012-9366]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[ Project Nos. 2758-010 and 2770-009]

The City of Holyoke Gas & Electric Department; Notice of
Application Accepted for Filing, Soliciting Comments, Motions To
Intervene, and Protests

    Take notice that the following hydroelectric application has been
filed with the Commission and is available for public inspection:
    a. Type of Application: Surrender of License.
    b. Project Nos.: 2758-010 and 2770-009.
    c. Date Filed: March 09, 2012.
    d. Applicant: The City of Holyoke Gas & Electric Department.
    e. Name of Project: Cocker Mill A/B & Crocker Mill (C Wheel).
    f. Location: On the Holyoke Canal, in Hampden County,
Massachusetts.
    g. Filed Pursuant to: 18 CFR 6.1.
    h. Applicant Contact: Mr. Paul Ducheney, Superintendent--Electric
Production, Holyoke Gas & Electric Department, 99 Suffolk Street,
Holyoke, MA 01040,<PHONE_NUMBER>, ducheney@hged@com; Nancy J. Skancke,
Law Offices of GKRSE, 1500 K St. NW., Suite 330, Washington, DC 20005,
(202) 408-5400<EMAIL_ADDRESS>    i. FERC Contact: Ms. Krista Sakallaris,<PHONE_NUMBER>,
<EMAIL_ADDRESS>    j. Deadline for filing comments, motions to intervene, and
protests, is 30 days from the issuance date of this notice. All
documents may be filed electronically via the Internet. See, 18 CFR
385.2001(a)(1)(iii) and the instructions on the Commission's Web site
at http://www.ferc.gov/docs-filing/efiling.asp. If unable to be filed
electronically, documents may be paper-filed. To paper-file, an
original and seven copies should be mailed to: Secretary, Federal
Energy Regulatory Commission, 888 First Street NE., Washington, DC
20426. Commenters can submit brief comments up to 6,000 characters,
without prior registration, using the eComment system at http://www.ferc.gov/docs-filing/ecomment.asp. You must include your name and
contact information at the end of your comments.
    Please include the project numbers (P-2758-010 & P-2770-009) on any
comments, motions, or protests filed.
    k. Description of Request: The applicant proposes to surrender the
license and decommission the generating facilities for the Crocker Mill
(A/B Wheels) Project (P-2758) and the Crocker Mill (C Wheel) Project
(P-2770). The applicant states that the projects are in poor condition
due to deterioration and partial demolition already performed. The
applicant proposes to shut off and secure the shared gated intake rack
structure; secure the penstocks, tailrace, and gate; disconnect the
generating equipment; and secure all other project works.
    l. Locations of the Application: A copy of the application is
available for inspection and reproduction at the Commission's Public
Reference Room, located at 888 First Street NE., Room 2A, Washington,
DC 20426, or by calling<PHONE_NUMBER>. This filing may also be viewed
on the Commission's Web site at http://www.ferc.gov/docs-filing/elibrary.asp. Enter the docket number excluding the last three digits
in the docket number field to access the document. You may also
register online at http://www.ferc.gov/docs-filing/esubscription.asp to
be notified via email of new filings and issuances related to this or
other pending projects. For assistance, call 1-866-208-3676 or email
<EMAIL_ADDRESS>for TTY, call<PHONE_NUMBER>. A copy is
also available for inspection and reproduction at the address in item
(h) above.
    m. Individuals desiring to be included on the Commission's mailing
list should so indicate by writing to the Secretary of the Commission.
    n. Comments, Protests, or Motions to Intervene: Anyone may submit
comments, a protest, or a motion to intervene in accordance with the
requirements of Rules of Practice and Procedure, 18 CFR 385.210, .211,
.214. In determining the appropriate action to take, the Commission
will consider all protests or other comments filed, but only those who
file a motion to intervene in accordance with the Commission's Rules
may become a party to the proceeding. Any comments, protests, or
motions to intervene must be received on or before the specified
comment date for the particular application.
    o. Filing and Service of Responsive Documents: Any filing must (1)
bear in all capital letters the title ``COMMENTS'', ``PROTEST'', or
``MOTION TO INTERVENE'' as applicable; (2) set forth in the heading the
name of the applicant and the project number of the application to
which the filing responds; (3) furnish the name, address, and telephone
number of the person protesting or intervening; and (4) otherwise
comply with the requirements of 18 CFR 385.2001 through 385.2005. All
comments, motions to intervene, or protests must set forth their
evidentiary basis and otherwise comply with the requirements of 18 CFR
4.34(b). All comments, motions to intervene, or protests should relate
to project works which are the subject of the license surrender.
Agencies may obtain copies of the application directly from the
applicant. A copy of any protest or motion to intervene must be served
upon each representative of the applicant specified in the particular
application. If an intervener files comments or documents with the
Commission relating to the merits of an issue that may affect the
responsibilities of a particular resource agency, they must also serve
a copy of the document on that resource agency. A copy of all other
filings in reference to this application must be accompanied by proof
of service on all persons listed in the service list prepared by the
Commission in this proceeding, in accordance with 18 CFR 4.34(b) and
385.2010.

    Dated: April 12, 2012.
Kimberly D. Bose,
Secretary.
[FR Doc. 2012-9366 Filed 4-18-12; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 78, Number 164 (Friday, August 23, 2013)]
[Proposed Rules]
[Pages 52465-52467]
[FR Doc No: 2013-20585]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2013-0699; Directorate Identifier 2012-NM-198-AD]
RIN 2120-AA64

Airworthiness Directives; Fokker Services B.V. Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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SUMMARY: We propose to adopt a new airworthiness directive (AD) for
certain Fokker Services B.V. Model F.28 Mark 0070 and 0100 airplanes.
This proposed AD was prompted by three reports of cracking in the rear
pressure bulkhead (RPBH) web. This proposed AD would require inspecting
the RPBH web for cracking, and repairing if necessary. We are proposing
this AD to detect and correct cracking of the RPBH web, which could
result in in-flight decompression of the airplane and possible injury
to the occupants.

DATES: We must receive comments on this proposed AD by October 7, 2013.

ADDRESSES: You may send comments by any of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov. Follow the instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE., Washington, DC 20590.
     Hand Delivery: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE., Washington, DC, between 9 a.m. and 5 p.m., Monday
through Friday, except Federal holidays.
    For service information identified in this proposed AD, contact
Fokker Services B.V., Technical Services Dept., P.O. Box 1357, 2130 EL
Hoofddorp, the Netherlands; telephone +31 (0)88-6280-350; fax +31
(0)88-6280-111; email<EMAIL_ADDRESS>Internet http://www.myfokkerfleet.com. You may review copies of the referenced service
information at the FAA, Transport Airplane Directorate, 1601 Lind
Avenue SW., Renton, WA. For information on the availability of this
material at the FAA, call<PHONE_NUMBER>.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://www.regulations.gov; or in person at the Docket Operations office
between 9 a.m. and 5 p.m., Monday through Friday, except Federal
holidays. The AD docket contains this proposed AD, the MCAI, the
regulatory evaluation, any comments received, and other information.
The street address for the Docket Operations office (telephone (800)
647-5527) is in the ADDRESSES section. Comments will be available in
the AD docket shortly after receipt.

FOR FURTHER INFORMATION CONTACT: Tom Rodriguez, Aerospace Engineer,
International Branch, ANM-116, Transport Airplane Directorate, FAA,
1601 Lind Avenue SW., Renton, Washington 98057-3356; telephone (425)
227-1137; fax<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Comments Invited

    We invite you to send any written relevant data, views, or
arguments about this proposed AD. Send your comments to an address
listed under the ADDRESSES section. Include ``Docket No. FAA-2013-0699;
Directorate Identifier 2012-NM-198-AD'' at the beginning of your
comments. We specifically invite comments on the overall regulatory,
economic, environmental, and energy aspects of this proposed AD. We
will consider all comments received by the closing date and may amend
this proposed AD based on those comments.
    We will post all comments we receive, without change, to http://www.regulations.gov, including any personal information you provide. We
will also post a report summarizing each substantive verbal contact we
receive about this proposed AD.

Discussion

    The European Aviation Safety Agency (EASA), which is the Technical
Agent for the Member States of the European Community, has issued EASA
Airworthiness Directive 2012-0219, dated October 19, 2012 (referred to
after this as the Mandatory Continuing Airworthiness Information, or
``the MCAI''), to correct an unsafe condition for the specified
products. The MCAI states:

    Three reports have been received of a crack in the rear pressure
bulkhead (RPBH) web, just below the horizontal beam XI between
buttock lines BL425L and BL425R, in the centre web bay below the
pressure relief valves.
    This condition, if not detected and corrected, could result in
an exponential crack growth rate, possibly leading to failure of the
affected RPBH web, resulting in in-flight decompression of the
aeroplane and possible injury to occupants.
    A repetitive inspection requirement has been published in issue
10 of Fokker Services [Airworthiness Limitations Section] ALS Report
SE-623 under task number 534106-00-05. The threshold to start this
ALS-task is 30,000 [total] flight cycles (FC). However, it is known
that many aeroplanes have already exceeded this threshold.
    For the reasons described above, this [EASA] AD requires a one-
time inspection [detailed visual or high frequency eddy current
inspection] of the affected RPBH web for cracks and, depending on
findings, accomplishment of a repair. The repair can also be applied
at any time as a modification, thereby exempting the aeroplane from
(further) repetitive ALS task 534106-00-05 inspections.

    You may obtain further information by examining the MCAI in the AD
docket.

Relevant Service Information

    Fokker Services B.V. has issued Fokker Service Bulletin SBF100-53-
120, dated May 15, 2012; and Fokker Service Bulletin SBF100-53-121,
dated May 15, 2012. The actions described in this service information
are intended to correct the unsafe condition identified in the MCAI.

FAA's Determination and Requirements of This Proposed AD

    This product has been approved by the aviation authority of another
country, and is approved for operation in the United States. Pursuant
to our bilateral agreement with the State of Design Authority, we have
been notified of the unsafe condition described in the MCAI and service
information referenced above. We are proposing this AD because we
evaluated all pertinent information and determined an unsafe condition
exists and is likely to exist or develop on other products of the same
type design.

Differences Between This Proposed AD and the MCAI or Service
Information

    The EASA AD 2012-0219, dated October 19, 2012, permits, under
certain conditions, postponement of crack repair. This proposed AD
would require repair before further flight for all cracking.

Costs of Compliance

    We estimate that this proposed AD affects 4 airplanes of U.S.
registry.
    We estimate the following costs to comply with this proposed AD:

                                                 Estimated Costs
----------------------------------------------------------------------------------------------------------------
                                                                                Cost per   Cost on U.S.
                 Action                              Labor cost             Parts cost    product     operators
----------------------------------------------------------------------------------------------------------------
Inspection..............................  5 work-hours x $85 per hour =            $0        $425        $1,700
                                           $425.
----------------------------------------------------------------------------------------------------------------

    We estimate the following costs to do any necessary repairs that
would be required based on the results of the proposed inspection. We
have no way of determining the number of aircraft that might need these
repairs:

                                               On-Condition Costs
----------------------------------------------------------------------------------------------------------------
                                                                                Cost per
                    Action                                    Labor cost                Parts cost     product
----------------------------------------------------------------------------------------------------------------
On-condition inspection and repair............  16 work-hours x $85 per hour = $1,360.         $0        $1,360
----------------------------------------------------------------------------------------------------------------

Authority for This Rulemaking

    Title 49 of the United States Code specifies the FAA's authority to
issue rules on aviation safety. Subtitle I, section 106, describes the
authority of the FAA Administrator. ``Subtitle VII: Aviation
Programs,'' describes in more detail the scope of the Agency's
authority.
    We are issuing this rulemaking under the authority described in
``Subtitle VII, Part A, Subpart III, Section 44701: General
requirements.'' Under that section, Congress charges the FAA with
promoting safe flight of civil aircraft in air commerce by prescribing
regulations for practices, methods, and procedures the Administrator
finds necessary for safety in air commerce. This regulation is within
the scope of that authority because it addresses an unsafe condition
that is likely to exist or develop on products identified in this
rulemaking action.

Regulatory Findings

    We determined that this proposed AD would not have federalism
implications under Executive Order 13132. This proposed AD would not
have 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.
    For the reasons discussed above, I certify this proposed
regulation:
    1. Is not a ``significant regulatory action'' under Executive Order
12866;
    2. Is not a ``significant rule'' under the DOT Regulatory Policies
and Procedures (44 FR 11034, February 26, 1979);
    3. Will not affect intrastate aviation in Alaska; and
    4. Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.
    We prepared a regulatory evaluation of the estimated costs to
comply with this proposed AD and placed it in the AD docket.

List of Subjects in 14 CFR Part 39

    Air transportation, Aircraft, Aviation safety, Incorporation by
reference, Safety.

The Proposed Amendment

    Accordingly, under the authority delegated to me by the
Administrator, the FAA proposes to amend 14 CFR part 39 as follows:

PART 39--AIRWORTHINESS DIRECTIVES

0
1. The authority citation for part 39 continues to read as follows:

    Authority:  49 U.S.C. 106(g), 40113, 44701.

Sec.  39.13  [Amended]

0
2. The FAA amends Sec.  39.13 by adding the following new AD:

Fokker Services B.V.: Docket No. FAA-2013-0699; Directorate
Identifier 2012-NM-198-AD.

(a) Comments Due Date

    We must receive comments by October 7, 2013.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to Fokker Services B.V. Model F.28 Mark 0070 and
0100 airplanes, certificated in any category, as identified in
Fokker Service Bulletin SBF100-53-120, dated May 15, 2012.

(d) Subject

    Air Transport Association (ATA) of America Code 53, Fuselage.

(e) Reason

    This AD was prompted by three reports of cracking in the rear
pressure bulkhead (RPBH) web. We are issuing this AD to detect and
correct cracking of the RPBH web, which could result in in-flight
decompression of the airplane and possible injury to the occupants.

(f) Compliance

    You are responsible for having the actions required by this AD
performed within the compliance times specified, unless the actions
have already been done.

(g) Inspection

    Before the accumulation of 30,000 total flight cycles, or within
12 months after the effective date of this AD, whichever occurs
later: Do the actions specified in paragraph (g)(1) or (g)(2) of
this AD.
    (1) Do a detailed inspection for cracking of the rear side of
the RPBH web below beam XI between buttock line (BL) 425L and BL
425R, in accordance with PART 1 of the Accomplishment Instructions
of Fokker Service Bulletin SBF100-53-120, dated May 15, 2012.
    (2) Do a high frequency eddy current (HFEC) inspection for
cracking of the forward side of the RPBH web below beam XI between
BL 425L and BL 425R, in accordance with PART 2 of the Accomplishment
Instructions of Fokker Service Bulletin SBF100-53-120, dated May 15,
2012.

    Note 1 to paragraph (g) of this AD: Fokker Services All
Operators Message AOF100.176, dated May 15, 2012; and AOF100.178,
dated September 10, 2012; provide additional information concerning
the subject addressed by this AD.

(h) On-condition Inspection and Repair

    (1) If any cracking is found during the inspections specified in
paragraph (g)(1) or (g)(2) of this AD: Before further flight, repair
the cracking, in accordance with the Accomplishment Instructions of
Fokker Service Bulletin SBF100-53-121, dated May 15, 2012.
    (2) For any airplane inspected as specified in paragraph (g)(1)
of this AD and no cracking was found: Within 12 months after that
inspection, do the HFEC inspection specified in PART 2 of the
Accomplishment Instructions of Fokker Service Bulletin SBF100-53-
120, dated May 15, 2012. If any cracking is found: Before further
flight, repair

the cracking, in accordance with the Accomplishment Instructions of
Fokker Service Bulletin SBF100-53-121, dated May 15, 2012.

(i) Other FAA AD Provisions

    The following provisions also apply to this AD:
    (1) Alternative Methods of Compliance (AMOCs): The Manager,
International Branch, ANM-116, Transport Airplane Directorate, FAA,
has the authority to approve AMOCs for this AD, if requested using
the procedures found in 14 CFR 39.19. In accordance with 14 CFR
39.19, send your request to your principal inspector or local Flight
Standards District Office, as appropriate. If sending information
directly to the International Branch, send it to ATTN: Tom
Rodriguez, Aerospace Engineer, International Branch, ANM-116,
Transport Airplane Directorate, FAA, 1601 Lind Avenue SW., Renton,
Washington 98057-3356; telephone<PHONE_NUMBER>; fax<PHONE_NUMBER>.
Information may be emailed to<EMAIL_ADDRESS>
Before using any approved AMOC, notify your appropriate principal
inspector, or lacking a principal inspector, the manager of the
local flight standards district office/certificate holding district
office. The AMOC approval letter must specifically reference this
AD.
    (2) Airworthy Product: For any requirement in this AD to obtain
corrective actions from a manufacturer or other source, use these
actions if they are FAA-approved. Corrective actions are considered
FAA-approved if they are approved by the State of Design Authority
(or their delegated agent). You are required to assure the product
is airworthy before it is returned to service.

(j) Related Information

    (1) Refer to Mandatory Continuing Airworthiness Information
(MCAI) European Aviation Safety Agency (EASA) Airworthiness
Directive 2012-0219, dated October 19, 2012, for related
information, which can be found in the AD docket on the Internet at
http://www.regulations.gov.
    (2) For service information identified in this AD, contact
Fokker Services B.V., Technical Services Dept., P.O. Box 1357, 2130
EL Hoofddorp, the Netherlands; telephone +31 (0)88-6280-350; fax +31
(0)88-6280-111; email<EMAIL_ADDRESS>Internet http://www.myfokkerfleet.com. You may review copies of the referenced
service information at the FAA, Transport Airplane Directorate, 1601
Lind Avenue SW., Renton, WA. For information on the availability of
this material at the FAA, call<PHONE_NUMBER>.

    Issued in Renton, Washington, on August 16, 2013.
Jeffrey E. Duven,
Acting Manager, Transport Airplane Directorate, Aircraft Certification
Service.
[FR Doc. 2013-20585 Filed 8-22-13; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 86, Number 119 (Thursday, June 24, 2021)]
[Notices]
[Pages 33472-33473]
[FR Doc No: 2021-13447]

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DEPARTMENT OF TRANSPORTATION

Federal Railroad Administration

[Docket No. FRA-2021-0064]

Petition for Approval: Alaska Railroad Corporation Approval
Extension

AGENCY: Federal Railroad Administration (FRA), Department of
Transportation (DOT).

ACTION: Notice of conditional approval.

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SUMMARY:  FRA is issuing this notice of conditional approval to Alaska
Railroad Corporation (ARRC) in response to its August 29, 2020,
petition to extend FRA's approval authorizing ARRC's transport of
Liquefied Natural Gas (LNG) by rail in cryogenic portable tanks (T75,
UN cryogenic portable tanks or cryogenic ISO tanks).

DATES: Comments are requested no later than August 23, 2021. FRA will
consider comments received after that date to the extent possible,
without incurring additional expense or delay.

ADDRESSES: All communications concerning these proceedings should
identify the appropriate docket number and may be submitted by any of
the following methods:
     Website: http://www.regulations.gov. Follow the online
instructions for submitting comments.
     Email<EMAIL_ADDRESS>    Anyone can search the electronic form of any written communications
and comments received into any of our dockets by the name of the
individual submitting the comment (or signing the document, if
submitted on behalf of an association, business, labor union, etc.).
Under 5 U.S.C. 553(c), DOT solicits comments from the public to better
inform its processes. DOT posts these comments, without edit, including
any personal information the commenter provides, to http://www.regulations.gov/ gov/, as described in the system of records notice
(DOT/ALL-14 FDMS), which can be reviewed at https://www.transportation.gov/privacy. See also https://www.regulations.gov/privacyNotice for the privacy notice of regulations.gov.

FOR FURTHER INFORMATION CONTACT: Mark Maday, Staff Director--Hazardous
Materials Division, Office of Railroad Safety, FRA, telephone: (202)
493-0479 or email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: On August 29, 2020, ARRC petitioned FRA for
an extension of an Approval granted by the Associate Administrator for
Railroad Safety in accordance with 49 CFR 174.63 of the Hazardous
Materials Regulations. FRA assigned the petition Docket Number FRA-
2021-0064.
    Specifically, ARRC sought extension of the approval issued under
Sec.  174.63 to transport Methane, refrigerated liquid, UN 1972,
Division 2.1 (Flammable gas), also commonly referred to as LNG, by rail
in UN cryogenic portable tanks secured on flat cars via the following
routes: (1) Mainline service between Seward, AK and Fairbanks, AK, and
(2) branch line service of approximately 12 miles between the Port of
Whittier, AK, and milepost 64.3 of the ARRC mainline.
    ARRC notes in its petition that it has not begun to commercially
transport LNG under the terms of its approval. However, in its petition
ARRC also notes that there is still a need for a clean and affordable
energy source for interior Alaska. As a state-owned railroad operating
under a statutory mandate to provide safe, efficient, and economical
transportation to meet the overall needs of the state and its citizens,
the ARRC is positioned to facilitate the solution. Additionally, ARRC
suggests that demand for natural gas transportation is increasing,
citing the recent installation of a 5.2-million-gallon storage tank by
the natural gas distributor in Fairbanks, AK. ARRC describes ongoing
business negotiations and developments that could soon result in
opportunities to move LNG commercially by rail. Finally, ARRC projects
that once commercial operations commence under the terms of the
approval, there may be a need to move as much as 60 portable tanks of
product every 4 days, utilizing two portable tanks per flatcar and a
maximum of 30 flatcars per train.
    FRA first granted ARRC's petition in 2015. FRA's safety assessment
was based upon detailed information provided by the ARRC, including
results of assessments that were conducted by ARRC and evaluated by FRA
technical experts for the routes over which LNG would be moved. In
2017, FRA modified the approval to expand the authorization to include
the additional 12-mile branch line route from Port of

Whittier, AK, to milepost 64.3 of the ARRC mainline. The previous
approval includes conditions to reduce risks to public safety and the
environment. FRA's previous approval letters are available in this
public Docket for reference.
    Although ARRC hasn't yet moved any product commercially by rail,
under the terms of FRA's previous approval, LNG has been moved
commercially in portable tanks on other rail networks since 2017
without incident. FRA is basing this approval on risk assessments for
similar operations it has approved. An analysis under the National
Environmental Policy Act was conducted for this approval; it was
determined to be covered by the categorical exclusion in 23 CFR
771.116(c)(15).
    FRA recognizes that public interest involving the safe
transportation of petroleum products and specifically LNG is
heightened, given recent regulatory actions. On July 24, 2020, the
Pipeline and Hazardous Materials Safety Administration published a
final rule \1\ authorizing the transportation of LNG in cryogenic tank
cars with enhanced outer tanks (e.g., DOT-113C120W9). In the final
rule, PHMSA indicated that 445 comments were submitted to the docket
during the comment period.\2\ In light of the heightened public
interest in the safe transportation of petroleum products, FRA believes
it is appropriate to provide public notice and opportunity to comment
on FRA's approval, to ensure that it contains all necessary conditions
to ensure the safety of ARRC's LNG operations.
---------------------------------------------------------------------------

    \1\ 85 FR 44994.
    \2\ See Docket No. PHMSA-2018-0025 available at
www.regulations.gov.
---------------------------------------------------------------------------

    FRA approves ARRC's request conditioned on compliance with
appropriate safety measures. All conditions of FRA's prior approvals
for ARRC remain in effect, with additional conditions added to ensure
safe operations. Below, FRA has generally listed its conditions of
approval, but further details on thee conditions are available in FRA's
conditional approval letter in the public docket.
    1. Mandatory inspections.
    2. Mandatory trainings.
    3. Load limitations.
    4. Reporting requirements.
    5. Container number restrictions.
    6. Prohibition on double stacking.
    7. Train placement requirement.
    8. Speed restrictions.
    9. Regular oversight.
    10. Risk assessment.
    FRA's approval is effective through December 31, 2022. If ARRC
desires to continue operations under this approval after December 31,
2022, it must notify FRA of its intent to continue operations no later
than September 1, 2022. If ARRC desires to modify its operations from
those permitted by FRA's approval letter, it must obtain FRA's approval
before implementing the proposed modification(s).

    Issued in Washington, DC.
John Karl Alexy,
Associate Administrator for Railroad Safety Chief Safety Officer.
[FR Doc. 2021-13447 Filed 6-23-21; 8:45 am]
BILLING CODE 4910-06-P


[Federal Register Volume 83, Number 205 (Tuesday, October 23, 2018)]
[Notices]
[Pages 53465-53466]
[FR Doc No: 2018-23117]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 6115-015]

Pyrites Hydroelectric Project; Notice of Intent To File License
Application, Filing of Pre-Application Document, and Approving Use of
the Traditional Licensing Process

    a. Type of Filing: Notice of Intent to File License Application and
Request to Use the Traditional Licensing Process.
    b. Project No.: 6115-015.
    c. Date Filed: August 31, 2018.
    d. Submitted By: Pyrites Hydro, LLC.
    e. Name of Project: Pyrites Hydroelectric Project.
    f. Location: On the Grass River, a tributary to the St. Lawrence
River, near the Town of Canton in St. Lawrence County, New York. No
federal lands are occupied by the project works or located within the
project boundary.
    g. Filed Pursuant to: 18 CFR 5.3 of the Commission's regulations.
    h. Potential Applicant Contact: Mr. Kevin M. Webb, Hydro Licensing
Manager, Pyrites Hydro, LLC, 100 Brickstone Square, Suite 300, Andover,
MA 01810,<PHONE_NUMBER>; [email protected]
    i. FERC Contact: Chris Millard at<PHONE_NUMBER>; or email at
[email protected].
    j. Pyrites Hydro, LLC filed a request to use the Traditional
Licensing Process on August 31, 2018 and provided public notice of the
request on August 31, 2018. In a letter dated October 17, 2018, the
Director of the Division of Hydropower Licensing approved Pyrites
Hydro, LLC's request to use the Traditional Licensing Process.
    k. With this notice, we are initiating informal consultation with
the U.S. Fish and Wildlife Service and/or NOAA Fisheries under section
7 of the Endangered Species Act and the joint agency regulations
thereunder at 50 CFR, part 402; and NOAA Fisheries under section 305(b)
of the Magnuson-Stevens Fishery Conservation and Management Act and
implementing regulations at 50 CFR 600.920. We are

also initiating consultation with the New York State Historic
Preservation Officer, as required by section 106, National Historic
Preservation Act, and the implementing regulations of the Advisory
Council on Historic Preservation at 36 CFR 800.2.
    l. With this notice, we are designating Pyrites Hydro, LLC as the
Commission's non-federal representative for carrying out informal
consultation pursuant to section 7 of the Endangered Species Act and
section 106 of the National Historic Preservation Act.
    m. Pyrites Hydro, LLC filed a Pre-Application Document (PAD;
including a proposed process plan and schedule) with the Commission,
pursuant to 18 CFR 5.6 of the Commission's regulations.
    n. A copy of the PAD is available for review at the Commission in
the Public Reference Room or may be viewed on the Commission's website
(http://www.ferc.gov), using the ``eLibrary'' link. Enter the docket
number, excluding the last three digits in the docket number field to
access the document. For assistance, contact FERC Online Support at
[email protected],<PHONE_NUMBER> (toll free), or (202) 502-
8659 (TTY). A copy is also available for inspection and reproduction at
the address in paragraph h.
    o. The licensee states its unequivocal intent to submit an
application for a new license for Project No. 6115-015. Pursuant to 18
CFR 16.8, 16.9, and 16.10, each application for a new license and any
competing license applications must be filed with the Commission at
least 24 months prior to the expiration of the existing license. All
applications for license for this project must be filed by August 31,
2021.
    p. Register online at http://www.ferc.gov/docs-filing/esubscription.asp to be notified via email of new filing and issuances
related to this or other pending projects. For assistance, contact FERC
Online Support.

    Dated: October 17, 2018.
Kimberly D. Bose,
Secretary.
[FR Doc. 2018-23117 Filed 10-22-18; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register: January 9, 2008 (Volume 73, Number 6)]
[Rules and Regulations]
[Page 1512-1517]
[DOCID:fr09ja08-7]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2005-0268; FRL-8345-8]

Poly(hexamethylenebiguanide) hydrochloride (PHMB); Exemption from
the Requirement of a Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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

SUMMARY: This regulation establishes an exemption from the requirement
of a tolerance for residues of the insecticide,
Poly(hexamethylenebiguanide) hydrochloride (PHMB) on all food when
residues are the result of lawful application of a food contact surface
sanitizer containing PHMB as a sanitizer solution in food handling
establishments when applied as a sanitizer. Arch Chemicals Inc.
submitted a petition to EPA under the Federal Food, Drug, and Cosmetic
Act (FFDCA), as amended by the Food Quality Protection Act of 1996
(FQPA), requesting an exemption from the requirement of a tolerance.
This regulation eliminates the need to establish a maximum permissible
level for residues of PHMB.

DATES: This regulation is effective January 9, 2008. Objections and
requests for hearings must be received on or before March 10, 2008, and
must be filed in accordance with the instructions provided in 40 CFR
part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION.

ADDRESSES: EPA has established a docket for this action under docket
identification (ID) number EPA-HQ-OPP-2005-0268. To access the
electronic docket, go to http://www.regulations.gov, select ``Advanced

Search,'' then ``Docket Search.'' Insert the docket ID number where
indicated and select the ``Submit'' button. Follow the instructions on
the regulations.gov website to view the docket index or access
available documents. All documents in the docket are listed in the
docket index available in regulations.gov. Although listed in the
index, some information is not publicly available, e.g., Confidential
Business Information (CBI) or other information whose disclosure is
restricted by statute. Certain other material, such as copyrighted
material, is not placed on the Internet and will be publicly available
only in hard copy form. Publicly available docket materials are
available either in the electronic docket at http://www.regulations.gov
, or, if only

available in hard copy, at the Office of Pesticide Programs (OPP)
Regulatory Public Docket in Rm. S-4400, One Potomac Yard (South Bldg.),
2777 S. Crystal Dr., Arlington, VA. The hours of operation of this
Docket Facility are from 8:30 a.m. to 4 p.m., Monday through Friday,
excluding legal holidays. The Docket Facility telephone number is (703)
305-5805.

FOR FURTHER INFORMATION CONTACT: Adam Heyward, Antimicrobials Division
(7510P), Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460-0001; telephone number:<PHONE_NUMBER>; e-mail
address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
Potentially affected entities may include, but are not limited to:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).
    This listing is not intended to be exhaustive, but rather provides
a guide for readers regarding entities likely to be affected by this
action. Other types of entities not listed in this unit could also be
affected. The North American Industrial Classification System (NAICS)
codes have been provided to assist you and others in determining
whether this action might apply to certain entities. To determine
whether you or your business may be affected by this action, you should
carefully examine the applicability provisions in 40 CFR 180.940(a)
Tolerance exemptions for active and inert ingredients for use in
antimicrobial formulations (Food-contact surface sanitizing solutions.
If you have any questions regarding the applicability of this action to
a particular entity, consult the person listed under FOR FURTHER
INFORMATION CONTACT.

 B. How Can I Access Electronic Copies of this Document?

    In addition to accessing an electronic copy of this Federal
Register document through the electronic docket at http://www.regulations.gov
, you may access this Federal Register document

electronically through the EPA Internet under the ``Federal Register''
listings at http://www.epa.gov/fedrgstr. You may also access a

frequently updated electronic version of 40 CFR part 180 through the
Government Printing Office's pilot e-CFR site at http://www.gpoaccess.gov/ecfr
.

C. Can I File an Objection or Hearing Request?

    Under section 408(g) of FFDCA, as amended by FQPA, any person may
file an objection to any aspect of this regulation and may also request
a hearing on those objections. The EPA procedural regulations which
govern the submission of objections and requests for hearings appear in
40 CFR part 178. You must file your objection or request a hearing on
this regulation in accordance with the instructions provided in 40 CFR
part 178. To ensure proper receipt by EPA, you must identify docket ID
number EPA-HQ-OPP-2005-0268 in the subject line on the first page of
your submission. All requests must be in writing, and must be mailed or
delivered to the Hearing Clerk on or before March 10, 2008.
    In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing that does not contain any CBI for inclusion in the public
docket that is described in ADDRESSES. Information not marked
confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA
without prior notice. Submit your copies, identified by docket ID
number EPA-HQ-OPP-2005-0268, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.

Follow the on-line instructions for submitting comments.
     Mail: Office of Pesticide Programs (OPP) Regulatory Public
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460-0001.
     Delivery: OPP Regulatory Public Docket (7502P),
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only
accepted during the Docket's normal hours of operation (8:30 a.m. to 4
p.m., Monday through Friday, excluding legal holidays). Special
arrangements should be made for deliveries of boxed information. The
Docket Facility telephone number is<PHONE_NUMBER>.

II. Background and Statutory Findings

    In the Federal Register of December 21, 2005 (70 FR 75805) (FRL-
7745-8), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21
U.S.C. 346a(d)(3), announcing the filing of a pesticide tolerance
petition (PP 5F6975) by Arch Chemical Inc.,1955 Lake Park Drive, Suite
100, Smyrna, GA 30080. The petition requested that 40 CFR part 180 be
amended by establishing an exemption from the requirement of a
tolerance for residues of Poly(hexamethylenebiguanide) hydrochloride.
This notice included a summary of the petition prepared by the
petitioner Arch Chemical Inc. There were no comments received in
response to the notice of filing.
    Section 408(c)(2)(A)(i) of FFDCA allows EPA to establish an
exemption from the requirement for a tolerance (the legal limit for a
pesticide chemical residue in or on a food) only if EPA determines that
the tolerance is ``safe.'' Section 408(c)(2)(A)(ii) of FFDCA defines
``safe'' to mean that ``there is a reasonable certainty that no harm
will result from aggregate exposure to the pesticide chemical residue,
including all anticipated dietary exposures and all other exposures for
which there is reliable information.'' This includes exposure through
drinking water and in residential settings, but does not include
occupational exposure. Pursuant to section 408(c)(2)(B) of FFDCA, in
establishing or maintaining in effect an exemption from the requirement
of a tolerance, EPA must take into account the factors set forth in
section 408(b)(2)(C) of FFDCA, which requires EPA to give special
consideration to exposure of infants and children to the pesticide
chemical residue in establishing a tolerance and to ``ensure that there
is a reasonable certainty that no harm will result to infants and
children from aggregate exposure to the pesticide chemical
residue....''
    EPA performs a number of analyses to determine the risks from
aggregate exposure to pesticide residues. First, EPA determines the
toxicity of pesticides. Second, EPA examines exposure to the pesticide
through food, drinking water, and through other exposures that occur as
a result of pesticide use in residential settings.

III. Toxicological Profile

A. Toxic Effects

    Consistent with section 408(b)(2)(D) of FFDCA, EPA has reviewed the
available scientific data and other relevant information in support of
this action and considered its validity, completeness and reliability
and the relationship of this information to human risk. EPA has also
considered available information concerning the variability of the
sensitivities of major identifiable subgroups of consumers, including
infants and children. The

nature of the toxic effects are discussed in this unit.
    There are adequate toxicology data available to characterize the
toxicity of PHMB. PHMB is a severe eye irritant and is a moderate
dermal irritant and sensitizer. Acute oral, inhalation and dermal
toxicity are acute toxicity, category III, which requires the signal
word caution to appear on the product label as defined in 40 CFR
156.64(3).

B. Toxic Endpoints

    For hazards that have a threshold below which there is no
appreciable risk, the dose at which no adverse effects are observed
(NOAEL) from the toxicology study identified as appropriate for the
risk assessment is used to estimate the toxicological level of concern
(LOC).
    The Agency's level of concern for residential PHMB dermal,
inhalation and oral exposures is 100 (i.e. a margin of exposure (MOE)
less than 100 exceeds the Agency's level of concern). The level of
concern is based on 10x for interspecies extrapolation and 10x for
intraspecies variability. A summary of the toxic endpoints for PHMB is
listed in the following table.

           Table 1--Toxicological Endpoints for Assessing Occupational and Residential Exposures/Risk*
----------------------------------------------------------------------------------------------------------------
                                                                 Special FQPA SF and
          ExposureScenario               Dose Used in Risk      Level of Concern for    Study and Toxicological
                                           Assessment, UF          Risk Assessment              Effects
----------------------------------------------------------------------------------------------------------------
Acute Dietary (Females 13-50 years    NOAEL = 20 mg/kg/day     FQPA SF = 1             Rabbit Developmental
 of age)                              UF = 100...............  aPAD = acute RfD /       Study (MRID 42865901)
                                      Acute RfD = 0.2 mg/kg/    FQPA SF= 0.2 mg/kg/    LOAEL = 40 mg/kg/day
                                       day.                     day.                    based on a reduced
                                                                                number of litters and
                                                                                skeletal abnormalities.
----------------------------------------------------------------------------------------------------------------
Acute Dietary (General population          No appropriate single dose effect was identified for the general
 including infants and children)                                      population.
----------------------------------------------------------------------------------------------------------------
Chronic Dietary (All populations)     NOAEL = 20 mg/kg/day     FQPA SF = 1             Rabbit Developmental
                                      UF = 100...............  cPAD = chronic RfD /     Study (MRID 42865901)
                                      Chronic RfD = 0.2 mg/kg/  FQPA SF= 0.2 mg/kg/    LOAEL = 40 mg/kg/day
                                       day.                     day.                    Based on increased
                                                                                mortality, reduced food
                                                                                consumption, and
                                                                                clinical toxicity;
                                                                                Mouse Developmental Study
                                                                                (Report No. CTL/P/335,
                                                                                1977 (cited in Report
                                                                                No. 003810, 1978.
                                                                                Section C-9))
                                                                                LOAEL = 40 mg/kg/day
                                                                                Based on reduced body
                                                                                weight gain; and
                                                                                Rat Developmental Study
                                                                                (Report No. CTL/P/1262,
                                                                                1976 (cited in Report
                                                                                No. 003810, 1978.
                                                                                Section C-11))
                                                                                LOAEL = 50 mg/kg/day
                                                                                Based on reduced food
                                                                                consumption.
----------------------------------------------------------------------------------------------------------------
Short-Term Incidental Oral (1-30      NOAEL = 20 mg/kg/day     Residential LOC for     Rabbit Developmental
 days)                                UF = 100...............   MOE = 100               Study (MRID 42865901)
                                                                                LOAEL = 40 mg/kg/day
                                                                                Based on the increased
                                                                                mortality, reduced food
                                                                                consumption, and
                                                                                clinical toxicity;
                                                                                Mouse Developmental Study
                                                                                (Report No. CTL/P/335,
                                                                                1977 (cited in Report
                                                                                No. 003810, 1978.
                                                                                Section C-9))
                                                                                LOAEL = 40 mg/kg/
                                                                                day;Based on reduced
                                                                                body weight gain; and
                                                                                Rat Developmental Study
                                                                                (Report No. CTL/P/1262,
                                                                                1976 (cited in Report
                                                                                No. 003810, 1978.
                                                                                Section C-11))
                                                                                LOAEL = 50 mg/kg/day
                                                                                Based on reduced food
                                                                                consumption.
----------------------------------------------------------------------------------------------------------------
Intermediate-Term Incidental Oral (1  NOAEL = 20 mg/kg/day     Residential LOC for     See Short-Term Incidental
 - 6 months)                          UF = 100...............   MOE = 100               Oral Endpoint
----------------------------------------------------------------------------------------------------------------
Short-Term, Intermediate-Term and     Dermal (or oral) study   Residential LOC for     80-Week Skin Painting
 Long-Term Dermal Exposure            NOAEL= 150 mg/kg/day...   MOE = 100               Study - Mouse (MRIDs
                                      UF =<PHONE_NUMBER>5 and 00104796)
                                      (Relative dermal                                 LOAEL = 750 mg/kg/day
                                       absorption rate =100%).                          based on decreased body
                                                                                weight and liver tumors.
----------------------------------------------------------------------------------------------------------------
Short-Term, Intermediate-Term and      An appropriate route-specific inhalation study is not available. The oral
 Long-Term Inhalation Exposure            endpoint of 20 mg/kg/day with a target MOE of 100 (10x inter-species
                                         extrapolation, 10x intra-species variation) is used. An additional 10x
                                          route-to-route extrapolation is used to determine if a confirmatory
                                                        inhalation toxicity study is warranted.
----------------------------------------------------------------------------------------------------------------
Cancer (oral, dermal)                  EPA has classified PHMB as having suggestive evidence of carcinogenicity
                                        but the evidence was too weak to warrant quantification of human cancer
                                                                          risk

----------------------------------------------------------------------------------------------------------------
*UF = uncertainty factor, FQPA SF = FQPA safety factor, NOAEL = no observed adverse effect level, LOAEL = lowest
  observed adverse effect level, PAD = acute population adjusted dose (a = acute, c = chronic) RfD = reference
  dose, LOC = level of concern, MOE = margin of exposure

IV. Aggregate Exposures

    In examining aggregate exposure, FFDCA section 408 directs EPA to
consider available information concerning exposures from the pesticide
residue in food and all other non-occupational exposures, including
drinking water from ground water or surface water and exposure through
pesticide use in gardens, lawns, or buildings (residential and other
indoor uses).

A. Dietary Exposure

    PHMB is an antimicrobial that is used as a hard surface sanitizer
and may be in or on food processing equipment, premises of food
processing plants, milk processing equipment, milk processing plants,
eating establishments, food contact surfaces, adhesives, and slurries.
The use of PHMB as an antimicrobial product on these various surfaces
may result in pesticide residues in human food. Residues from treated
surfaces can migrate to food that comes into contact with the treated
surfaces which then can result in human ingestion.
    1. Food. The Agency assessed acute and chronic dietary exposure
from the use of PHMB as a disinfectant and food contact sanitizer on
direct and indirect food-contact surfaces. This assessment calculated
the Daily Dietary Dose (DDD) and the Estimated Daily Intake (EDI) using
an FDA model (``Sanitizing Solutions: Chemical Guidelines for Food
Additives Petition, January 1993''). The FDA model takes into account
application rates, residual solution, area of the treated surface which
comes into contact with food, pesticide migration fraction, and body
weight of the population exposed.
    To calculate the EDI (estimated daily intake) values for PHMB when
it is used as a sanitizer in public eating spaces, it was assumed that
PHMB would be used at a concentration of 550 parts per million (ppm),
the thickness of the PHMB residues on surfaces would be 1 mg per square
centimeter of treated surface, and the surface area of the food contact
surface being sanitized to which a person would be exposed on a daily
basis is 4,000 cm2 (which includes contact with treated
silverware, china, and glass used by an individual who regularly eats
three meals per day at an institutional or public facility). It was
also assumed that 100% of the pesticide would migrate to food.
    To calculate the EDI (estimated daily intake) values for PHMB when
it is used in the food processing industry, it was also assumed to be
used at a concentration of 550 ppm. However, specific to this scenario,
the exposure estimates were calculated using the milk truck model that
is described in the FDA document, ``Sanitizing Solutions: Chemistry
Guidelines For Food Additive Petitions.'' This includes the assumption
that estimates of sanitary exposure from use in dairy processing plants
significantly exceed estimates based on other uses with food processing
equipment and utensils. For the purpose of assessing risks stemming
from food processing uses, parameters assuming a sanitized milk truck
were used as the worst case scenario. The various input parameters,
such as the size of the truck, internal surface area, residual
thickness, and application rate of PHMB were used to calculate
potential residues present in the truck per liter of food (i.e. milk).
    For each dietary exposure assessment it was assumed that adults
(both male and female) consume 3,000 grams of food a day and a child,
1,500 grams. This allowed for an estimation of the amount of PHMB that
is anticipated to be present in an average adult's or child's daily
intake from these uses, and in turn, the calculation of a daily dietary
dose.
    2. Drinking water exposure. The uses of PHMB are not expected to
significantly contaminate drinking water sources. As provided in the
PHMB Reregistration Eligibility Document, ``none of the uses associated
with PHMB are expected to impact either surface or ground water
resources.'' Therefore, the PHMB contributions for drinking water
exposure are considered to be negligible and are not quantified.

B. Other Non-Occupational Exposure

    The residential exposure assessment considers all potential non-
occupational pesticide exposure, other than exposure due to residues in
food or in drinking water. Exposures may occur during and after
application as a hard surface disinfectant (e.g. walls, floors, tables,
fixtures) and to swimming pools. Each route of exposure is assessed,
where appropriate, and risk is expressed as a margin of exposure (MOE),
which is the ratio of estimated exposure to an appropriate NOAEL.
    Residential exposure may occur during application of PHMB to indoor
hard surfaces (e.g., mopping, wiping, trigger pump sprays) and to
swimming pools. The residential handler scenarios were assessed to
determine dermal and inhalation exposures. Surrogate dermal and
inhalation unit exposure values were estimated using Pesticide Handler
Exposure Database (PHED) data and the Chemical Manufactures Association
Anitmicrobial Exposure Assessment Study (USEPA, 1999) and the SWIMODEL
3.0 was utilized to conduct exposure assessments of pesticides found in
swimming pools and spas (Versar, 2003). Note that for this assessment,
EPA assumed that residential users complete all elements of an
application (mix/load/apply) without the use of personal protective
equipment.
    The duration for most residential exposures is believed to be best
represented by short-term duration (1 to 30 days). The short-term
duration was chosen for this assessment because the residential handler
and post-application scenarios are assumed to be performed on an
episodic, not a daily basis.
    Based on toxicological criteria and the potential for exposure, the
Agency has conducted incidental oral, dermal and inhalation exposure
assessments for PHMB residential use. As noted previously, MOEs greater
than or equal to 100 are considered adequately protective for the
residential exposure assessment.
    Specific information on the residential exposure for PHMB can be
found at http://www.regulations.gov, docket ID No. EPA-HQ-OPP-2005-

0268.

V. Cumulative Effects

    Section 408(b)(2)(D)(v) of the FFDCA requires that, when
considering whether to establish, modify, or revoke a tolerance, the
Agency consider ``available information'' concerning the cumulative
effects of a particular pesticide's residues and ``other substances
that have a common mechanism of toxicity.''
    Unlike other pesticides for which EPA has followed a cumulative
risk approach based on a common mechanism of toxicity, EPA has not made
a common mechanism of toxicity finding as to PHMB and any other
substances and PHMB does not appear to produce a toxic metabolite
produced by other substances. For the purposes of this tolerance
action, therefore, EPA has not assumed that PHMB has a common mechanism
of toxicity with other substances. For information regarding EPA's
efforts to determine which chemicals have a common mechanism of
toxicity and to evaluate the cumulative effects of such chemicals, see
EPA's website at http://www.epa.gov/pesticides/cumulative.

VI. Safety Factor for Infants and Children

    1. In general. Section 408 of FFDCA provides that EPA shall apply
an additional (``10x'') tenfold margin of safety for infants and
children in the

case of threshold effects to account for prenatal and postnatal
toxicity and the completeness of the data base on toxicity and exposure
unless EPA determines based on reliable data that a different margin of
safety will be safe for infants and children. This additional margin of
safety is commonly referred to as the FQPA safety factor. In applying
this provision, EPA either retains the default value of 10x when
reliable data do not support the choice of a different factor, or, if
reliable data are available, EPA uses a different additional FQPA
safety factor value based on the use of traditional uncertainty/safety
factors and/or special FQPA safety factors, as appropriate.
    2. Prenatal and postnatal sensitivity. There is no quantitative or
qualitative evidence of increased susceptibility to the fetus following
in utero exposure to PHMB in the prenatal developmental toxicity
studies, and no quantitative or qualitative evidence of increased
susceptibility to the offspring when adults are exposed to PHMB in the
two-generation reproductive study. In each study, any development/
reproductive effect observed occurred at doses equal to or higher than
the doses at which maternal toxicity was observed. This, together with
the nature of the effects seen in the studies has led the Agency to
conclude that there is no evidence of increased susceptibility.
    EPA has determined that reliable data show that it would be safe
for infants and children to reduce the FQPA safety factor to 1x. That
decision is based on the following findings:
    i. The toxicity database for Poly(hexamethylenebiguanide)
hydrochloride (PHMB) is complete for assessing risk to infants and
children under the FFDCA.
    ii. There is no indication that PHMB is a neurotoxic chemical and
there is no need for a developmental neurotoxicity study or additional
uncertainty factors to account for neurotoxicity.
    iii. There is no evidence that PHMB results in increased
susceptibility in in utero rats or rabbits in the prenatal
developmental studies or in young rats in the two-generation
reproduction study.
    iv. There are no residual uncertainties identified in the exposure
databases. The dietary food exposure assessments were performed based
on 100% crop treated (CT) and tolerance-level residues and will not
underestimate the exposure and risk. Conservative ground and surface
water modeling estimates were used. Similarly conservative Residential
SOPs were used to assess post-application exposure to children as well
as incidental oral exposure of toddlers. These assessments will not
underestimate the exposure and risks posed by PHMB.

VII. Determination of Safety for U.S. Population, Infants and Children

    Safety is assessed for acute and chronic risks by comparing
aggregate exposure to the pesticide to the acute population adjusted
dose (``aPAD'') and chronic population adjusted dose (``cPAD''). The
aPAD and cPAD are calculated by dividing the LOC by all applicable
uncertainty/safety factors. For linear cancer risks, EPA calculates the
probability of additional cancer cases given aggregate exposure. Short-
, intermediate-, and long-term risks are evaluated by comparing
aggregate exposure to the LOC to ensure that the MOE called for by the
product of all applicable uncertainty/safety factors is not exceeded.
    1. Acute and chronic risk. EPA compares the estimated dietary
exposures to an aPAD and a cPAD, both of which are 0.2 mg/kg/day for
PHMB. Generally, a dietary exposure estimate that is less than 100% of
the aPAD or cPAD does not exceed the Agency's levels of concern.
    The antimicrobial indirect food use acute/chronic risk estimates
from exposure to treated utensils and countertops as well as from food
processing facility sanitation are below the Agency's level of concern.
For adults females of child bearing age (13 to 49 years old), the
cumulative (food utensils and food processing) acute and chronic
dietary exposure risk estimates are 18.8% of the acute and chronic
PADs. For children ages 3 to 5 years old, the most highly exposed
population subgroup, the cumulative chronic dietary risk estimates are
37.2% of chronic PAD (there are no effects anticipated for the acute
exposures). Therefore, dietary exposure estimates are below the
Agency's level of concern for all population subgroups. Based on the
information in this preamble, EPA concludes that there is a reasonable
certainty of no harm from aggregate exposure to residues. Accordingly,
EPA finds that exempting from the requirement of a tolerance will be
safe.
    2. Non-occupational risk. Aggregate exposure takes into account
residential exposure plus chronic exposure to food and water
(considered to be a background exposure level).
    Using the exposure assumptions described in this unit for other
non-occupational exposures, EPA has concluded that food, water, and
residential exposures aggregated result in aggregate MOEs greater than
or equal to 100 for the inhalation route of exposure and 100 for dermal
exposure. Therefore, these levels of exposure are not of concern.
    3. Aggregate cancer risk for U.S. population. EPA has classified
PHMB as having no greater than suggestive evidence of carcinogenicity.
The weight-of-the-evidence considerations for this classification are
as follows:
    i. A treatment-related statistically significant increase (trend
and pair-wise) in vascular tumors (mainly benign) was seen in female
rats at an oral dose that was considered to be adequate, but not
excessive. This was considered the strongest evidence on the Agency's
evaluation of PHMB.
    ii. Oral exposure to male and female mice also resulted in
treatment-related vascular tumors seen at an excessive dose. However,
at the next highest dose level, which was considered adequate but not
excessive, there was a slight, but not statistically significant,
increase in this same tumor, which added to the Agency's concern for
this tumor type.
    iii. It is noted that dermal exposure to female mice resulted in an
equivocal increase in vascular tumors seen at only an excessive dose.
    iv. No treatment-related increase in any tumors was seen in male
rats via the oral route or in male mice via the dermal route of
exposure.
    Based on the findings above, the Agency has determined that PHMB
posed no greater than a negligible cancer risk.
    4. Determination of safety. Based on these risk assessments, EPA
concludes that there is a reasonable certainty that no harm will result
to the general population or to infants and children from aggregate
exposure to PHMB. Accordingly, EPA finds that exempting PHMB from the
requirement of a tolerance will be safe.

VII. Other Considerations

A. Endocrine Disruptors

    EPA is required under the FFDCA, as amended by FQPA, to develop a
screening program to determine whether certain substances (including
all pesticide active and other ingredients) ``may have an effect in
humans that is similar to an effect produced by a naturally occurring
estrogen, or other such endocrine effects as the Administrator may
designate.'' Following the recommendations of its Endocrine Disruptor
Screening and Testing Advisory Committee (EDSTAC), EPA determined that
there was scientific basis for including, as part of the program, the
androgen and thyroid hormone systems, in addition to the estrogen
hormone system. EPA also

adopted EDSTAC's recommendation that the Program include evaluations of
potential effects in wildlife. For pesticide chemicals, EPA will use
the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), and,
to the extent that effects in wildlife may help determine whether a
substance may have an effect in humans, FFDCA has authority to require
the wildlife evaluations. As the science develops and resources allow,
screening of additional hormone systems may be added to the Endocrine
Disruptor Screening Program (EDSP).
    When the appropriate screening and/or testing protocols being
considered under the Agency's EDSP have been developed, PHMB may be
subjected to additional screening and/or testing to better characterize
effects related to endocrine disruption.

B. Analytical Method(s)

    An analytical method for food is not needed. Food contact
sanitizers are typically regulated by state health departments to
ensure that the food industry is using these products in compliance
with regulations in 40 CFR 180.940. The end use solution that is
applied to the food contact surface is analyzed not food items that may
come into contact with the treated surface. An analytical method is
available to analyze the use dilution that is applied to food contact
surfaces. The solution can be analyzed by use of the spectrophotometric
method.

C. Existing Tolerances

    There is no existing tolerance or exemption from tolerance for
PHMB.

D. International Tolerances

    No Codex, Canadian, or Mexican maximum residue limits (MRLs) have
been established for any food uses at this time.

VIII. Statutory and Executive Order Reviews

    This final rule establishes a tolerance under section 408(d) of
FFDCA in response to a petition submitted to the Agency. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled Regulatory Planning and
Review (58 FR 51735, October 4, 1993). Because this final rule has been
exempted from review under Executive Order 12866, this rule is not
subject to Executive Order 13211, Actions Concerning Regulations That
Significantly Affect Energy Supply, Distribution, or Use (66 FR 28355,
May 22, 2001) or Executive Order 13045, entitled Protection of Children
from Environmental Health Risks and Safety Risks (62 FR 19885, April
23, 1997). This final rule does not contain any information collections
subject to OMB approval under the Paperwork Reduction Act (PRA), 44
U.S.C. 3501 et seq., nor does it require any special considerations
under Executive Order 12898, entitled Federal Actions to Address
Environmental Justice in Minority Populations and Low-Income
Populations (59 FR 7629, February 16, 1994).
    Since tolerances and exemptions that are established on the basis
of a petition under section 408(d) of FFDCA, such as the tolerance in
this final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.) do not apply.
    This final rule directly regulates growers, food processors, food
handlers, and food retailers, not States or tribes, nor does this
action alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of section 408(n)(4) of FFDCA. As such, the Agency has determined that
this action will not have a substantial direct effect on States or
tribal governments, on the relationship between the national government
and the States or tribal governments, or on the distribution of power
and responsibilities among the various levels of government or between
the Federal Government and Indian tribes. Thus, the Agency has
determined that Executive Order 13132, entitled Federalism (64 FR
43255, August 10, 1999) and Executive Order 13175, entitled
Consultation and Coordination with Indian Tribal Governments (65 FR
67249, November 6, 2000) do not apply to this final rule. In addition,
this final rule does not impose any enforceable duty or contain any
unfunded mandate as described under Title II of the Unfunded Mandates
Reform Act of 1995 (UMRA) (Public Law 104-4).
    This action does not involve any technical standards that would
require Agency consideration of voluntary consensus standards pursuant
to section 12(d) of the National Technology Transfer and Advancement
Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272
note).

IX. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report to each House of the Congress and to
the Comptroller General of the United States. EPA will submit a report
containing this rule and other required information to the U.S. Senate,
the U.S. House of Representatives, and the Comptroller General of the
United States prior to publication of this final rule in the Federal
Register. This final rule is not a ``major rule'' as defined by 5
U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.

    Dated: December 18, 2007.
Betty Shackleford,
Acting Director, Antimicrobials Division, Office of Pesticide Programs.

0
Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

0
1. The authority citation for part 180 continues to read as follows:

    Authority: 21 U.S.C. 321(q), 346a and 371.

0
2. Section 180.1280 is added to subpart D to read as follows:

Sec.  180.1280  Poly(hexamethylenebiguanide) hydrochloride (PHMB)
exemption from the requirement of a tolerance.

    Poly(hexamethylenebiguanide) hydrochloride (PHMB)(CAS Reg. No.
32289-58-0) is exempt from the requirement of a tolerance for residues
of the antimicrobial in or on all food commodities when the residues
are the result of the lawful application of a food contact surface
sanitizer containing PHMB at 550 parts per million (ppm).

[FR Doc. E8-189 Filed 1-8-08; 8:45 am]

BILLING CODE 6560-50-S