[Federal Register Volume 80, Number 123 (Friday, June 26, 2015)]
[Rules and Regulations]
[Pages 36710-36713]
[FR Doc No: 2015-15612]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2014-0524; Directorate Identifier 2014-NM-042-AD;
Amendment 39-18189; AD 2015-13-02]
RIN 2120-AA64

Airworthiness Directives; Bombardier, Inc. Airplanes

AGENCY: Federal Aviation Administration (FAA), Department of
Transportation (DOT).

ACTION: Final rule.

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SUMMARY: We are adopting a new airworthiness directive (AD) for certain
Bombardier, Inc. Model DHC-8-400 series airplanes. This AD was prompted
by reports of corrosion in the low-rate discharge tubes of the fire
protection system leading to the forward baggage compartment, and
perforation of one or more tubes. This AD requires repetitive checks
for leakage of the discharge tubes of the fire protection system. This
AD also mandates eventual replacement of all existing aluminum tube
assemblies with new, improved corrosion-resistant stainless steel tube
assemblies. We are issuing this AD to prevent perforation of the low-
rate discharge tubes, which could result in insufficient fire
extinguishing agent reaching the forward baggage compartment in the
event of a fire, which could result in damage to the airplane and
injury to the occupants.

DATES: This AD becomes effective July 31, 2015
    The Director of the Federal Register approved the incorporation by
reference of a certain publication listed in this AD as of July 31,
2015.

ADDRESSES: You may examine the AD docket on the Internet at http://www.regulations.gov/#!docketDetail;D=FAA-2014-0524 or in person at the
Docket Management Facility, U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE., Washington, DC.
    For service information identified in this AD, contact Bombardier,
Inc., Q-Series Technical Help Desk, 123 Garratt Boulevard, Toronto,
Ontario M3K 1Y5, Canada; telephone<PHONE_NUMBER>; fax<PHONE_NUMBER>;
email<EMAIL_ADDRESS>Internet http://www.bombardier.com. You may view this 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>. It is also available on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2014-
0524.

FOR FURTHER INFORMATION CONTACT: Fabio Buttitta, Aerospace Engineer,
Airframe and Mechanical Systems Branch, ANE-171, FAA, New York Aircraft
Certification Office (ACO), 1600 Stewart Avenue, Suite 410, Westbury,
NY 11590; telephone<PHONE_NUMBER>; fax<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Discussion

    We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR
part 39 by adding an AD that would apply to certain Bombardier, Inc.
Model DHC-8-400 series airplanes. The NPRM published in the Federal
Register on August 13, 2014 (79 FR 47384).
    Transport Canada Civil Aviation (TCCA), which is the aviation
authority for Canada, has issued Canadian Airworthiness Directive CF-
2014-06, dated January 21, 2014 (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:

    Corrosion has been reported in the fire protection system low
rate discharge tubes leading to the forward baggage compartment. In
some cases, this has led to perforation of one or more tubes.
    Perforation of forward baggage compartment fire protection
system tubes may result in decreased effectiveness of the fire
protection system in the event of a fire in the forward baggage
compartment.
    This [Canadian] AD mandates a repetitive integrity check of the
forward baggage compartment fire protection system tube assemblies,
and the replacement of aluminum forward baggage compartment fire
protection tube assemblies with corrosion resistant stainless steel
(CRES) tubes.

    The unsafe condition is perforation of the low-rate discharge
tubes, which could result in insufficient fire extinguishing agent
reaching the forward baggage compartment and reduce the capability of
the fire protection system to extinguish fires, possibly resulting in
damage to the

airplane and injury to occupants. You may examine the MCAI in the AD
docket on the Internet at http://www.regulations.gov/#!documentDetail;D=FAA-2014-0524-0004.

Comments

    We gave the public the opportunity to participate in developing
this AD. The following presents the comments received on the NPRM (79
FR 47384, August 13, 2014) and the FAA's response to each comment.

Request To Remove Certain Service Information Procedures

    Horizon Air requested that the language in paragraph (g) of the
NPRM (79 FR 47384, August 13, 2014) be changed to specify only required
actions. Instead of mandating the entire Accomplishment Instructions of
Bombardier Service Bulletin 84-26-15, Revision A, dated January 15,
2014, Horizon Air recommended mandating only the actions necessary to
correct the identified unsafe condition. Horizon Air stated that the
Accomplishment Instructions, Part A, ``Job Set-up,'' and Part C,
``Close Out,'' have nothing to do with correcting the unsafe condition.
Horizon Air reasoned that mandating operators to perform these actions
restricts operators' ability to perform other maintenance in
conjunction with incorporation of the required actions specified in
this AD.
    We agree with the commenter's request to exclude the ``Job Set-up''
and ``Close Out'' sections of the Accomplishment Instructions of
Bombardier Service Bulletin 84-26-15, Revision A, dated January 15,
2014, from this AD. We have revised the introductory text of paragraphs
(g) and (h) of this AD for clarification because there are two sections
in the service information which contain paragraph 3.B. ``Procedure.''
Accomplishment of the actions specified in paragraph 3.B.,
``Procedure,'' of Parts A and B, as applicable, of the Accomplishment
Instructions of Bombardier Service Bulletin 84-26-15, Revision A, dated
January 15, 2014, is required by this AD.

Second Alternative for Failed Integrity Check

    Horizon Air also asked that a second alternative for a failed
integrity check be included in paragraph (i) of the NPRM (79 FR 47384,
August 13, 2014). Horizon Air stated that, as an alternative to
replacing all tubes by incorporating Bombardier Service Bulletin 84-26-
15, Revision A, dated January 15, 2014, operators should be allowed the
option to replace only the leaking tubes using Bombardier Service
Bulletin 84-26-15, dated January 7, 2013. Horizon Air noted that it
would then repeat the integrity check required by the paragraph (g) of
the proposed AD. Horizon Air stated that disabling the forward baggage
compartment is not a viable option in its operation.
    We agree with the commenter. As an additional option for a failed
integrity check, operators may replace only the leaking tubes and
return the airplane to service if no additional leakage is found. We
have added a new paragraph (i)(2) to this AD to include this option in
lieu of disabling the forward baggage compartment. We have also re-
designated paragraphs (i)(1), (i)(2), and (i)(3) of the proposed AD to
paragraphs (i)(1)(i), (i)(1)(ii), and (i)(1)(iii) of this AD.

Request to Remove or Change Exception to Service Information

    All Nippon Airways requested that the exception to the electrical
bonding resistance check specified in paragraph (j) of the proposed AD
(79 FR 47384, August 13, 2014), be either removed or clarified. All
Nippon Airways stated that, if the electrical bonding resistance check
of the high rate discharge bottle was deleted from the referenced
service information, it should also be removed from the NPRM. If the
FAA disagrees, All Nippon Airways asked that we clarify the language in
paragraph (j) of the proposed AD.
    We agree that the electrical bonding resistance check of the high
rate discharge bottle was removed from Bombardier Service Bulletin 84-
26-15, Revision A, dated January 15, 2014. The electrical bonding
resistance check was identified in Bombardier Service Bulletin 84-26-
15, dated June 7, 2013, and was subsequently included in the exception
identified in the NPRM (79 FR 47384, August 13, 2014). Therefore, we
have removed paragraph (j) of the proposed AD from this final rule and
re-designated subsequent paragraphs accordingly. Instead, we have
included that exception in the Credit for Previous Actions specified in
paragraph (j) of this AD (identified as paragraph (k) of the proposed
AD).

Conclusion

    We reviewed the relevant data, considered the comments received,
and determined that air safety and the public interest require adopting
this AD with the changes described previously and minor editorial
changes. We have determined that these minor changes:
     Are consistent with the intent that was proposed in the
NPRM (79 FR 47384, August 13, 2014) for correcting the unsafe
condition; and
     Do not add any additional burden upon the public than was
already proposed in the NPRM (79 FR 47384, August 13, 2014).
    We also determined that these changes will not increase the
economic burden on any operator or increase the scope of this AD.

Related Service Information Under 1 CFR Part 51

    Bombardier, Inc. has issued Service Bulletin 84-26-15, Revision A,
dated January 15, 2014. The service information describes procedures
for repetitive checks for leakage of the discharge tubes of the fire
protection system. The service information also mandates eventual
replacement of all existing aluminum tube assemblies with new, improved
corrosion-resistant stainless steel tube assemblies. This service
information is reasonably available because the interested parties have
access to it through their normal course of business or by the means
identified in the ADDRESSES section of this AD.

Costs of Compliance

    We estimate that this AD affects 82 airplanes of U.S. registry.
    We also estimate that it would take about 42 work-hours per product
to comply with the basic requirements of this AD. The average labor
rate is $85 per work-hour. Required parts will cost about $7,852 per
product. Based on these figures, we estimate the cost of this AD on
U.S. operators to be $936,604, or $11,422 per product.

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 AD will not have federalism implications
under Executive Order 13132. This AD will 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 that this AD:
    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.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://www.regulations.gov/#!docketDetail;D=FAA-2014-0524-0004; or in person
at the Docket Management Facility between 9 a.m. and 5 p.m., Monday
through Friday, except Federal holidays. The AD docket contains this
AD, the regulatory evaluation, any comments received, and other
information. The street address for the Docket Operations office
(telephone<PHONE_NUMBER>) is in the ADDRESSES section.

List of Subjects in 14 CFR Part 39

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

Adoption of the Amendment

    Accordingly, under the authority delegated to me by the
Administrator, the FAA amends 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 airworthiness
directive (AD):

2015-13-02 Bombardier, Inc.: Amendment 39-18189. Docket No. FAA-
2014-0524; Directorate Identifier 2014-NM-042-AD.

(a) Effective Date

    This AD becomes effective July 31, 2015.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to Bombardier, Inc. Model DHC-8-400, -401, and -
402 airplanes, certificated in any category, serial numbers 4001
through 4424 inclusive.

(d) Subject

    Air Transport Association (ATA) of America Code 26, Fire
protection.

(e) Reason

    This AD was prompted by reports of corrosion in the low-rate
discharge tubes of the fire protection system leading to the forward
baggage compartment, and perforation of one or more tubes. We are
issuing this AD to prevent perforation of the low-rate discharge
tubes, which could result in insufficient fire extinguishing agent
reaching the forward baggage compartment in the event of a fire,
which could result in damage to the airplane and injury to the
occupants.

(f) Compliance

    Comply with this AD within the compliance times specified,
unless already done.

(g) Repetitive Inspections

    At the applicable time specified in paragraph (g)(1) or (g)(2)
of this AD, perform an inspection (integrity check) for leakage of
the fire protection tube assemblies of the forward baggage
compartment, in accordance with paragraph 3.B., ``Procedure,'' of
Part A of the Accomplishment Instructions of Bombardier Service
Bulletin 84-26-15, Revision A, dated January 15, 2014. If no leakage
is found, repeat the inspection at intervals not to exceed 2,000
flight hours or 12 months, whichever occurs first. If any leakage is
found, before further flight, do the terminating action required by
paragraph (h) of this AD, except as provided by paragraph (i) of
this AD.
    (1) For airplanes that have accumulated 10,000 total flight
hours or more, or have been in service for 60 months or more as of
the effective date of this AD: Within 2,000 flight hours or 12
months after the effective date of this AD, whichever occurs first.
    (2) For airplanes that have accumulated less than 10,000 total
flight hours, and have been in service for less than 60 months, as
of the effective date of this AD: Before the accumulation of 12,000
total flight hours or 72 months in service, whichever occurs first.

(h) Terminating Action for Repetitive Inspections

    At the applicable time specified in paragraph (h)(1) or (h)(2)
of this AD: Replace all existing aluminum tube assemblies of the
forward baggage compartment with new, improved corrosion-resistant
stainless steel tube assemblies, in accordance with paragraph 3.B.,
``Procedure,'' of Part B of the Accomplishment Instructions of
Bombardier Service Bulletin 84-26-15, Revision A, dated January 15,
2014. Accomplishing this replacement terminates the repetitive
inspections required by paragraph (g) of this AD.
    (1) For airplanes that have accumulated 12,000 total flight
hours or more, or have been in service for 72 months or more, as of
the effective date of this AD: Within 6,000 flight hours or 36
months after the effective date of this AD, whichever occurs first.
    (2) For airplanes that have accumulated less than 12,000 total
flight hours, and have been in service for less than 72 months, as
of the effective date of this AD: Before the accumulation of 18,000
total flight hours or 108 months in service, whichever occurs first.

(i) Alternatives to Replacement for Failed Integrity Check

    (1) As an alternative to the immediate tube assembly replacement
following any failed inspection (integrity check) required by
paragraph (g) of this AD, the airplane may be returned to service
for a maximum of 10 days, provided the conditions specified in
paragraphs (i)(1)(i), (i)(1)(ii), and (i)(1)(iii) of this AD are
met.
    (i) The forward baggage compartment is empty. For ballast
purposes, the use of bags (made of glass fiber or Kevlar) of sand or
ingots of non-magnetic metals (such as lead) are acceptable.
    (ii) The flight compartment and forward baggage compartment are
placarded to indicate the forward baggage compartment is
inoperative.
    (iii) An appropriate entry in the aircraft maintenance log is
made.
    (2) As an alternative to the immediate tube assembly replacement
following any failed inspection (integrity check) required by
paragraph (g) of this AD, the airplane may be returned to service
for a maximum of 10 days provided no additional leakage is found.
Any tubes found with a leak are to be replaced before further
flight, in accordance with the Accomplishment Instructions of
Bombardier Service Bulletin 84-26-15, dated January 7, 2013.

(j) Credit for Previous Actions

    This paragraph provides credit for actions required by
paragraphs (g) and (h) of this AD, as applicable, if those actions
were performed before the effective date of this AD using Bombardier
Service Bulletin 84-26-15, dated June 7, 2013, which is not
incorporated by reference in this AD. The electrical bonding
resistance check of the high rate discharge bottle specified in
Bombardier Service Bulletin 84-26-15, dated June 7, 2013, is not
required.

(k) Other FAA AD Provisions

    The following provisions also apply to this AD:
    (1) Alternative Methods of Compliance (AMOCs): The Manager, New
York Aircraft Certification Office (ACO), ANE-170, 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 New York ACO, send it to ATTN: Program Manager,
Continuing Operational Safety, FAA, New York ACO, 1600 Stewart
Avenue, Suite 410, Westbury, NY 11590; telephone<PHONE_NUMBER>; fax

516-794-553. 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) Contacting the Manufacturer: For any requirement in this AD
to obtain corrective actions from a manufacturer, the action must be
accomplished using a method approved by the Manager, New York ACO,
ANE-170, Engine and Propeller Directorate, FAA; or Transport Canada
Civil Aviation (TCCA); or Bombardier, Inc.'s TCCA Design Approval
Organization (DAO). If approved by the DAO, the approval must
include the DAO-authorized signature.

(l) Related Information

    (1) Refer to Mandatory Continuing Airworthiness Information
(MCAI) Canadian Airworthiness Directive CF-2014-06, dated January
21, 2014, for related information. This MCAI may be found in the AD
docket on the Internet at http://www.regulations.gov/#!documentDetail;D=FAA-2014-0524-0004.
    (2) Service information identified in this AD that is not
incorporated by reference is available at the addresses specified in
paragraphs (m)(3) and (m)(4) of this AD.

(m) Material Incorporated by Reference

    (1) The Director of the Federal Register approved the
incorporation by reference (IBR) of the service information listed
in this paragraph under 5 U.S.C. 552(a) and 1 CFR part 51.
    (2) You must use this service information as applicable to do
the actions required by this AD, unless this AD specifies otherwise.
    (i) Bombardier Service Bulletin 84-26-15, Revision A, dated
January 15, 2014.
    (ii) Reserved.
    (3) For service information identified in this AD, contact
Bombardier, Inc., Q-Series Technical Help Desk, 123 Garratt
Boulevard, Toronto, Ontario M3K 1Y5, Canada; telephone<PHONE_NUMBER>;
fax<PHONE_NUMBER>; email<EMAIL_ADDRESS>Internet
http://www.bombardier.com.
    (4) You may view this 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
425-227-1221.
    (5) You may view this service information that is incorporated
by reference at the National Archives and Records Administration
(NARA). For information on the availability of this material at
NARA, call<PHONE_NUMBER>, or go to: http://www.archives.gov/federal-register/cfr/ibr-locations.html.

    Issued in Renton, Washington on June 17, 2015.
Michael Kaszycki,
Acting Manager, Transport Airplane Directorate, Aircraft Certification
Service.
[FR Doc. 2015-15612 Filed 6-25-15; 8:45 am]
 BILLING CODE 4910-13-P


[Federal Register Volume 78, Number 132 (Wednesday, July 10, 2013)]
[Notices]
[Pages 41392-41393]
[FR Doc No: 2013-16560]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. EL13-75-000]

Indicated Load-Serving Entities v. Midcontinent Independent
System Operator, Inc. and PJM Interconnection, L.L.C.; Notice of
Complaint

    Take notice that on July 2, 2013, the Indicated Load-Serving
Entities, (Indicated LSEs or Complainants) within the Midcontinent
Independent System Operator, Inc. (MISO) filed a formal complaint
against MISO and PJM Interconnection, L.L.C. (PJM or Respondents),
pursuant to sections 206, 306 and 309 of the Federal Power Act, 16 USC
824e, 825c, and 825h and 18 CFR 385.206 (2013), requesting that the
Commission direct PJM to repay monies to MISO, and MISO in turn, to
repay monies to the Indicated LSEs. The funds in question relate to an
after-the-fact Market to Market resettlement, the costs of which are
borne by the Indicated LSEs, under the MISO--PJM Joint Operating
Agreement (JOA), as more fully described in Indicated LSEs' complaint.
    The Indicated LSEs certify that copies of the complaint were served
on the contacts for PJM and MISO as listed on the Commission's list of
Corporate Officials.

    Any person desiring to intervene or to protest this filing must
file in accordance with Rules 211 and 214 of the Commission's Rules of
Practice and Procedure (18 CFR 385.211, 385.214). 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. Any person wishing to become a party must file a notice of
intervention or motion to intervene, as appropriate. The Respondent's
answer and all interventions, or protests must be filed on or before
the comment date. The Respondent's answer, motions to intervene, and
protests must be served on the Complainants.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper using the ``eFiling'' link at http://www.ferc.gov. Persons unable to file electronically should submit an
original and 5 copies of the protest or intervention to the Federal
Energy Regulatory Commission, 888 First Street NE., Washington, DC
20426.
    This filing is accessible on-line at http://www.ferc.gov, using the
``eLibrary'' link and is 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 email
notification when a document is added to a subscribed docket(s). For
assistance with any FERC Online service, please email
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For
TTY, call<PHONE_NUMBER>.
    Comment Date: 5:00 p.m. Eastern Time on July 22, 2013.

    Dated: July 3, 2013.
Kimberly D. Bose,
Secretary.
[FR Doc. 2013-16560 Filed 7-9-13; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 84, Number 172 (Thursday, September 5, 2019)]
[Notices]
[Pages 46720-46721]
[FR Doc No: 2019-19132]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings

    Take notice that the Commission has received the following Natural
Gas Pipeline Rate and Refund Report filings:

Filings Instituting Proceedings

    Docket Number: PR19-74-000.
    Applicants: DTE Gas Company.
    Description: Tariff filing per 284.123(b),(e)/: DTE Gas Company
Rate Filing to be effective 9/1/2019.
    Filed Date: 8/28/19.
    Accession Number:<PHONE_NUMBER>77.
    Comments/Protests Due: 5 p.m. ET 9/18/19.

    Docket Number: PR19-75-000.
    Applicants: DCP Raptor Pipeline, LLC.
    Description: Tariff filing per 284.123(b)(2)+(g): DCP Raptor
Pipeline, LLC Rate Case to be effective 9/1/2019.
    Filed Date: 8/28/19.
    Accession Number:<PHONE_NUMBER>38.
    Comments Due: 5 p.m. ET 9/18/19.
    284.123(g) Protests Due: 5 p.m. ET 10/28/19.

    Docket Numbers: RP19-1488-000.
    Applicants: Natural Gas Pipeline Company of America.
    Description: Sec.  4(d) Rate Filing: Amendment to a Negotiated Rate
Agreement--Macquarie to be effective 8/28/2019.
    Filed Date: 8/28/19.
    Accession Number: 20190828-5000.
    Comments Due: 5 p.m. ET 9/9/19.

    Docket Numbers: RP19-1489-000.
    Applicants: Texas Gas Transmission, LLC.
    Description: Sec.  4(d) Rate Filing: Filing to incorporate approved
changes (RP19-1057 into RP19-1387) to be effective 8/28/2019.
    Filed Date: 8/28/19.
    Accession Number: 20190828-5024.
    Comments Due: 5 p.m. ET 9/9/19.

    Docket Numbers: RP19-1490-000.
    Applicants: Algonquin Gas Transmission, LLC.
    Description: Sec.  4(d) Rate Filing: Negotiated Rate--Boston to SFE
799788 eff 9-1-19 to be effective 9/1/2019.
    Filed Date: 8/28/19.
    Accession Number: 20190828-5028.
    Comments Due: 5 p.m. ET 9/9/19.

    Docket Numbers: RP19-1491-000.
    Applicants: Algonquin Gas Transmission, LLC.
    Description: Sec.  4(d) Rate Filing: Negotiated Rate--BUG to Emera
799788 eff 9-1-19 to be effective 9/1/2019.
    Filed Date: 8/28/19.
    Accession Number: 20190828-5034.
    Comments Due: 5 p.m. ET 9/9/19.

    Docket Numbers: RP19-1492-000.
    Applicants: Florida Gas Transmission Company, LLC.
    Description: Sec.  4(d) Rate Filing: Fuel Filing on 8-28-19 to be
effective 10/1/2019.
    Filed Date: 8/28/19.
    Accession Number: 20190828-5097.
    Comments Due: 5 p.m. ET 9/9/19.

    The filings are accessible in the Commission's eLibrary system by
clicking on the links or querying the docket number.
    Any person desiring to intervene or protest in any of the above
proceedings must file in accordance with Rules 211 and 214 of the
Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00
p.m. Eastern time on the specified date(s). Protests may be considered,
but intervention is necessary to become a party to the proceeding.
    eFiling is encouraged. More detailed information relating to filing
requirements, interventions, protests, service, and qualifying
facilities filings can be found at: http://www.ferc.gov/docs-filing/efiling/filing-req.pdf. For other information, call<PHONE_NUMBER>
(toll free). For TTY, call<PHONE_NUMBER>.

    Dated: August 29, 2019.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2019-19132 Filed 9-4-19; 8:45 am]
 BILLING CODE 6717-01-P


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197
Federal Register /Vol. 73, No. 1 /Wednesday, January 2, 2008 /Notices
Description of Respondents:
Respondents to this collection of
information are manufacturers, packers,
and distributors whose name (under
section 502(b)(1) of the act) appears on
the label of a nonprescription drug
marketed in the United States.
Burden Estimate: FDA is requesting
public comment on the estimated one-
time reporting burden from these
respondents, as required by Public Law
109
–462 and described in the draft
guidance. This guidance document
discusses the labeling requirements of
section 502(x) of the act (21 U.S.C.
352(x)), which was added by Public Law
109
–462.
Section 502(x) of the act requires the
label of an OTC drug product marketed
without an approved application in the
United States to include a domestic
address or domestic phone number
through which the responsible person
may receive a report of a serious adverse
event associated with the product. If the
label does not include the required
domestic address or phone number, the
drug product is misbranded. When the
responsible person chooses to provide a
domestic address (rather than a phone
number) for adverse event reporting,
FDA concludes that the statute requires
the product label to bear a full U.S.
mailing address that includes the street
address or P.O. Box, city, state, and zip
code of the responsible person (i.e., the
manufacturer, packer, distributor, or
retailer whose name appears on the
label). This labeling requirement helps
to ensure that any mailed adverse event
report will reach the responsible person.
Similarly, when the responsible person
chooses to provide a domestic phone
number for adverse event reporting,
FDA concludes that the statute requires
the phone number on the product label
to include the area code. Without the
area code, the phone number is
incomplete and does not serve its
intended purpose of enabling the
consumer to contact the responsible
person to report a serious adverse event.
In addition to discussing the statutory
requirement that labels include a
domestic address or a domestic phone
number, the draft guidance includes
recommendations about the location of
this information on the label and the
recommendation that the label make
clear the purpose of this information.
FDA estimates the burden of this
collection of information as follows:
TABLE 1.óESTIMATED ONE-TIME REPORTING BURDEN
1
No. of
Respondents
Frequency
per Response
Total
Responses
Hours Per
Response
Total Hours
Domestic address or phone number labeling requirement (21
U.S.C. 502(x)) and recommendation to clarify its purpose
200
500
100,000
4
400,000
1
There are no capital costs or maintenance and operating costs associated with this collection of information.
As indicated in Table 1 of this
document, we estimate that
approximately 200 manufacturers will
revise approximately 100,000 labels
total to add a full domestic address and
a domestic telephone number, and
should they choose to adopt the draft
guidanceís recommendation, to add a
statement identifying the purpose of the
domestic address or telephone number.
We specifically request comments on
these estimates. FDA believes that
designing the label change should not
take longer than 4 hours per label.
Automated printing of the labels should
only require a few seconds per label.
IV. Comments
Interested persons may submit to the
Division of Dockets Management (see
ADDRESSES
) written or electronic
comments regarding the draft guidance,
including comments regarding proposed
collection of information. Submit a
single copy of electronic comments or
two paper copies of any mailed
comments, except that individuals may
submit one paper copy. Comments are
to be identified with the docket number
found in brackets in the heading of this
document. The draft guidance and
received comments are available for
public examination in the Division of
Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday.
V. Electronic Access
Persons with access to the Internet
may obtain the document at either
http://www.fda.gov/cder/guidance/
index.htm or http://www.fda.gov/
ohrms/dockets/default.htm.
Dated: December 26, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 07ñ6267 Filed 12ñ27ñ07; 3:08 pm]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2007D–0491]
Draft Guidance for Industry: Questions
and Answers Regarding the Labeling
of Dietary Supplements as Required by
the Dietary Supplement and
Nonprescription Drug Consumer
Protection Act; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY:
The Food and Drug
Administration (FDA) is announcing the
availability of a draft guidance entitled
‘‘Questions and Answers Regarding the
Labeling of Dietary Supplements as
Required by the Dietary Supplement
and Nonprescription Drug Consumer
Protection Act.íí This draft guidance is
intended to assist the dietary
supplement industry in complying with
the labeling requirements prescribed for
dietary supplement manufacturers,
packers, and distributors by the Dietary
Supplement and Nonprescription Drug
Consumer Protection Act (the
DSNDCPA). Separate guidance, issued
by the Center for Drug Evaluation and
Research on labeling requirements for
nonprescription (over-the-counter)
human drugs marketed without an
approved application, is announced
elsewhere in this issue of the Federal
Register.
DATES:
Although you can comment on
any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the agency
considers your comment on this draft
guidance before it begins work on the
final version of the guidance, submit
written or electronic comments on the
draft guidance by March 3, 2008.
ADDRESSES:
Submit written requests for
single copies of the draft guidance to the
Office of Nutritional Products, Labeling,
and Dietary Supplements (HFSñ800),
Food and Drug Administration, 5100
Paint Branch Pkwy., College Park, MD
20740. Send one self-addressed
adhesive label to assist the office in
processing your request, or include a fax
number to which the draft guidance
may be sent. See the
SUPPLEMENTARY
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198
Federal Register /Vol. 73, No. 1 /Wednesday, January 2, 2008 /Notices
INFORMATION
section for electronic
access to the draft guidance.
Submit written comments on the draft
guidance, including comments
regarding proposed collection of
information, to the Division of Dockets
Management (HFAñ305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852. Submit
electronic comments to either http://
www.fda.gov/dockets/ecomments or
http://www.regulations.gov.
FOR FURTHER INFORMATION CONTACT:
Vasilios Frankos, Center for Food Safety
and Applied Nutrition (HFSñ810), Food
and Drug Administration, 5100 Paint
Branch Pkwy., College Park, MD 20740,
301
–436–2375.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of
a draft guidance entitled ëëGuidance for
Industry: Questions and Answers
Regarding the Labeling of Dietary
Supplements as Required by the Dietary
Supplement and Nonprescription Drug
Consumer Protection Act.íí On
December 22, 2006, the President signed
into law the DSNDCPA (Public Law
109
–462, 120 Stat. 3469). This law
amends the Federal Food, Drug, and
Cosmetic Act (the act) with respect to
serious adverse event reporting for
dietary supplements and non-
prescription drugs marketed without an
approved application. The draft
guidance document contains questions
and answers relating to the new labeling
requirements for dietary supplements
under the DSNDCPA.
The draft guidance is being issued
consistent with FDAís good guidance
practices regulation (21 CFR 10.115).
The draft guidance, when finalized, will
represent FDAís current thinking on this
topic. It does not create or confer any
rights for or on any person and does not
operate to bind FDA or the public. An
alternative approach may be used if
such approach satisfies the requirement
of the applicable statutes and
regulations.
II. Paperwork Reduction Act of 1995
Under the Paperwork Reduction Act
of 1995 (the PRA) (44 U.S.C. 3501ñ
3520), Federal agencies must obtain
approval from the Office of Management
and Budget (OMB) for each collection of
information they conduct or sponsor.
‘‘Collection of information’’ is defined
in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes agency requests
or requirements that members of the
public submit reports, keep records, or
provide information to a third party.
Section 3506(c)(2)(A) of the PRA (44
U.S.C. 3506(c)(2)(A)) requires Federal
agencies to provide a 60-day notice in
the Federal Register concerning each
proposed collection of information
before submitting the collection to OMB
for approval. To comply with this
requirement, FDA is publishing notice
of the proposed collection of
information set forth in this document.
With respect to the following
collection of information, FDA invites
comment on these topics: (1) Whether
the proposed collection of information
is necessary for the proper performance
of FDAís functions, including whether
the information will have practical
utility; (2) the accuracy of FDAís
estimate of the burden of the proposed
collection of information, including the
validity of the methodology and
assumptions used; (3) ways to enhance
the quality, utility, and clarity of the
information to be collected; and (4)
ways to minimize the burden of the
collection on respondents, including
through the use of automated collection
techniques, when appropriate, and other
forms of information technology.
Title: Dietary Supplement Labeling
Requirements and Recommendations
under the Dietary Supplement and
Nonprescription Drug Consumer
Protection Act.
Description of Respondents:
Respondents to this collection of
information are manufacturers, packers,
and distributors of dietary supplements
marketed in the United States.
The draft guidance is intended to
assist the dietary supplement industry
in complying with the dietary
supplement labeling requirements of
section 403(y) of the act (21 U.S.C.
343(y)), which was added by the
DSNDCPA.
Section 403(y) of the act requires the
label of a dietary supplement being
marketed in the United States to include
a domestic address or domestic
telephone number through which the
responsible person may receive a report
of a serious adverse event with such
dietary supplement. If the label does not
include the required domestic address
or telephone number, the dietary
supplement is misbranded. When the
responsible person chooses to provide a
domestic address (rather than a
telephone number) for adverse event
reporting, FDA concludes that the
statute requires the product label to bear
a full U.S. mailing address that includes
the street address or P.O. box, city, state,
and zip code of the responsible person
(i.e., the manufacturer, packer,
distributor, or retailer identified on the
dietary supplement label). This labeling
requirement helps to ensure that any
mailed adverse event report will reach
the responsible person. Similarly, when
the responsible person chooses to
provide a domestic telephone number
for adverse event reporting, FDA
concludes that the statute requires the
telephone number on the product label
to include the area code. Without the
area code, the telephone number is
incomplete and does not serve its
intended purpose of enabling the
consumer to contact the responsible
person to report a serious adverse event.
In addition to discussing the statutory
requirement for dietary supplement
labels to include a domestic address or
a domestic telephone number, the draft
guidance recommends that the label
bear a clear, prominent statement
informing consumers that the domestic
address or telephone number is for
reporting serious adverse events
associated with use of the product.
FDA estimates the burden of this
collection of information as follows:
TABLE 1.óESTIMATED ANNUAL REPORTING BURDEN
1
No. of
Respondents
Annual Frequency
per Response
Total Annual
Responses
Hours per
Response
Total Hours
Domestic address or telephone
number labeling requirement
(21 U.S.C. 343(y))
1,460
15.4616
22,574
4
90,296
FDA recommendation for label
statement explaining purpose
of domestic address or tele-
phone number
1,460
15.4616
22,574
4
90,296
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Federal Register /Vol. 73, No. 1 /Wednesday, January 2, 2008 /Notices
TABLE 1.óESTIMATED ANNUAL REPORTING BURDEN óContinued
1
No. of
Respondents
Annual Frequency
per Response
Total Annual
Responses
Hours per
Response
Total Hours
Total Burden Hours
180,592
1
There are no capital costs or operating and maintenance costs associated with this collection of information.
Using FDAís Labeling Cost Model,
FDA estimates that there are 22,574
stockkeeping units (SKUs) for unique
dietary supplement pills and liquids for
which labels would have to bear the
complete domestic address or domestic
telephone number of the responsible
person for that supplement. This
estimate of the number of SKUs for
dietary supplements is an underestimate
of the total number of dietary
supplements on the market because
dietary supplements are marketed in a
variety of forms other than pills and
liquids. However, this is the most
comprehensive estimate available to
FDA. FDA requests comments on the
total number of SKUs for dietary
supplements that are marketed in the
United States.
In the economic impact analysis of
the Dietary Supplement Good
Manufacturing Practices final rule (the
GMP final rule) FDA estimated that
there were about 1,460 dietary
supplement manufacturers, re-
packagers, re-labelers, and holders of
dietary supplements (June 25, 2007; 72
FR 34752 at 34920). Assuming the
22,574 SKUs are split equally among the
firms, then each firm would be
responsible for updating about 15 SKUs.
The estimate of the number of
manufacturers, re-packagers, re-labelers,
and holders of dietary supplements
from the GMP final rule is FDAís best
estimate of the number of firms that are
‘‘responsible persons’’ who must
comply with the new labeling
requirement added by the DSNDCPA;
however, it is not a precise estimate
because the number of dietary
supplement establishments covered by
the GMP final rule is likely to be larger
than the number of ëëresponsible
persons,íí where a ëëresponsible personíí
is a dietary supplement manufacturer,
packer, or distributor whose name is
listed on the label of a dietary
supplement associated with a serious
adverse event (see section 761(b)(1) of
the act (21 U.S.C. 379aañ1(b)(1)). Thus,
FDAís estimate for number of
respondents in table 1 of this document
may be over inclusive. FDA requests
comments on the number of firms that
would be subject to the labeling
requirements of the DSNDCPA.
FDA does not know how many of the
22,574 dietary supplement SKUs would
have to undergo a label change to
include the complete domestic address
or domestic telephone number of the
responsible person as required by the
DSNDCPA. Based on the agencyís
experience with regulating dietary
supplements, FDA believes that some
dietary supplement labels (SKUs)
already have the full domestic address
or telephone number of the responsible
person printed on the label and thus
will not need to be redesigned to
comply with section 403(y) of the act.
The agency does not have any
information on which to base a
quantitative estimate of the number of
labels that already meet the
requirements of section 403(y) of the
act, however. Therefore, FDA is
assuming conservatively that all labels
will need to be redesigned.
Assuming further that redesigning a


[Federal Register Volume 87, Number 78 (Friday, April 22, 2022)]
[Notices]
[Pages 24152-24153]
[FR Doc No: 2022-08552]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. CD22-5-000]

City of Portland, Oregon; Notice of Preliminary Determination of
a Qualifying Conduit Hydropower Facility and Soliciting Comments and
Motions To Intervene

    On April 12, 2022, as supplemented on April 13, 2022, the City of
Portland, Oregon, through its Water Bureau, filed a notice of intent to
construct a qualifying conduit hydropower facility, pursuant to section
30 of the Federal Power Act (FPA). The proposed Washington Park
Reservoir Hydroelectric Project would have an installed capacity of 30
kilowatts (kW), and would be located along an existing 24-inch pipeline
at the applicant's Washington Park Reservoir in Portland, Multnomah
County, Oregon.
    Applicant Contact: Susan Priddy, InPipe Energy, 920 SE 6th Ave 12th
Floor, Portland, OR 97204,<PHONE_NUMBER>, [email protected].
    FERC Contact: Christopher Chaney,<PHONE_NUMBER>,
[email protected].
    Qualifying Conduit Hydropower Facility Description: The proposed
project would consist of: (1) One 30 kW turbine/generator unit; (2) 10-
inch-diameter intake and discharge pipes; and (3) appurtenant
facilities. The proposed project would have an estimated annual
generation of approximately 77 megawatt-hours.
    A qualifying conduit hydropower facility is one that is determined
or deemed to meet all the criteria shown in the table below.

                          Table 1--Criteria for Qualifying Conduit Hydropower Facility
----------------------------------------------------------------------------------------------------------------
           Statutory provision                                  Description                      Satisfies (Y/N)
----------------------------------------------------------------------------------------------------------------
FPA 30(a)(3)(A)..........................  The conduit the facility uses is a tunnel, canal,                  Y
                                            pipeline, aqueduct, flume, ditch, or similar
                                            manmade water conveyance that is operated for the
                                            distribution of water for agricultural, municipal,
                                            or industrial consumption and not primarily for the
                                            generation of electricity.
FPA 30(a)(3)(C)(i).......................  The facility is constructed, operated, or maintained               Y
                                            for the generation of electric power and uses for
                                            such generation only the hydroelectric potential of
                                            a non-federally owned conduit.
FPA 30(a)(3)(C)(ii)......................  The facility has an installed capacity that does not               Y
                                            exceed 40 megawatts.
FPA 30(a)(3)(C)(iii).....................  On or before August 9, 2013, the facility is not                   Y
                                            licensed, or exempted from the licensing
                                            requirements of Part I of the FPA.
----------------------------------------------------------------------------------------------------------------

    Preliminary Determination: The proposed Washington Park Reservoir
Hydroelectric Project will not alter the primary purpose of the
conduit, which is to transport water for municipal use. Therefore,
based upon the above criteria, Commission staff preliminarily
determines that the proposal satisfies the requirements for a
qualifying conduit hydropower facility, which is not required to be
licensed or exempted from licensing.
    Comments and Motions to Intervene: Deadline for filing comments
contesting whether the facility meets the qualifying criteria is 30
days from the issuance date of this notice.
    Deadline for filing motions to intervene is 30 days from the
issuance date of this notice.
    Anyone may submit comments or a motion to intervene in accordance
with the requirements of Rules of Practice and Procedure, 18 CFR
385.210 and 385.214. Any motions to intervene must be received on or
before the specified deadline date for the particular proceeding.
    Filing and Service of Responsive Documents: All filings must (1)
bear in all capital letters the ``COMMENTS CONTESTING QUALIFICATION FOR
A CONDUIT HYDROPOWER FACILITY'' or ``MOTION TO INTERVENE,'' as
applicable; (2) state in the heading the name of the applicant and the
project number of the application to which the filing responds; (3)
state the name, address, and telephone number of the person filing; and
(4) otherwise comply with the requirements of sections 385.2001 through
385.2005 of the Commission's regulations.\1\ All comments contesting
Commission staff's preliminary determination that the facility meets
the qualifying criteria must set forth their evidentiary basis.
---------------------------------------------------------------------------

    \1\ 18 CFR 385.2001-2005 (2021).
---------------------------------------------------------------------------

    The Commission strongly encourages electronic filing. Please file
motions to intervene and comments using the Commission's eFiling system
at http://www.ferc.gov/docs-filing/efiling.asp. 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. For assistance, please contact FERC Online
Support at [email protected],<PHONE_NUMBER> (toll free), or
(202) 502-8659 (TTY). In lieu of electronic filing, you may send a
paper copy. Submissions sent via the U.S. Postal Service must be
addressed to: Kimberly D. Bose, Secretary, Federal Energy Regulatory
Commission, 888 First Street NE, Room 1A, Washington, DC 20426.
Submissions sent via any other carrier must be addressed to: Kimberly
D. Bose, Secretary, Federal Energy Regulatory Commission, 12225 Wilkins
Avenue, Rockville, MD 20852. 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 385.2010.
    Locations of Notice of Intent: The Commission provides all
interested

persons an opportunity to view and/or print the contents of this
document via the internet through the Commission's website at http://www.ferc.gov/docs-filing/elibrary.asp. Enter the docket number (i.e.,
CD22-5) 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. Copies of the notice of intent can be obtained
directly from the applicant. For assistance, call toll-free 1-866-208-
3676 or email [email protected]. For TTY, call<PHONE_NUMBER>.

    Dated: April 15, 2022.
Debbie-Anne A. Reese,
Deputy Secretary.
[FR Doc. 2022-08552 Filed 4-21-22; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register: October 16, 2009 (Volume 74, Number 199)]
[Rules and Regulations]
[Page 53174-53179]
[DOCID:fr16oc09-14]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2009-0076; FRL-8794-4]

Azoxystrobin; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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

SUMMARY: This regulation amends the established tolerances for residues
of azoxystrobin in or on barley bran; barley grain; and barley straw.
Interregional Research Project Number 4 (IR-4) requested these
tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective October 16, 2009. Objections and
requests for hearings must be received on or before December 15, 2009,
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-2009-0076. All documents in the
docket are listed in the docket index available at http://
www.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 in the electronic
docket at http://www.regulations.gov, or, if only available in hard
copy, at the OPP Regulatory Public Docket in Rm. S-4400, One Potomac
Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The Docket
Facility is open 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: Laura Nollen, Registration Division
(7505P), Office of Pesticide Programs, 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 those
engaged in the following activities:
     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 to
provide 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. 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 electronically available documents 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 EPA's tolerance regulations
at 40 CFR part 180 through the Government Printing Office's e-CFR cite
at http://www.gpoaccess.gov/ecfr.

C. Can I File an Objection or Hearing Request?

    Under section 408(g) of FFDCA, 21 U.S.C. 346a, any person may file
an objection to any aspect of this regulation and may also request a
hearing on those objections. 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-2009-0076 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 as required by 40 CFR part 178
on or before December 15, 2009.
    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 this copy, identified by docket ID number
EPA-HQ-OPP-2009-0076, 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 Facility'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. Petition for Tolerance

    In the Federal Register of April 8, 2009 (74 FR 15971) (FRL-8407-
4), 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 petition (PP
8E7474) by Interregional Research Project Number 4 (IR-4), IR-4 Project
Headquarters, 500 College Rd. East, Suite 201 W., Princeton, NJ 08540.
The petition requested that 40 CFR 180.507 be amended by increasing
established tolerances for residues of the fungicide azoxystrobin,
[methyl( E )-2-(2-(6-(2-cyanophenoxy) pyrimidin-4-yloxy)phenyl)-3-
methoxyacrylate] and the Z-isomer of azoxystrobin, [methyl( Z )-2-(2-
(6-(2-cyanophenoxy)pyrimidin-4-yloxy)phenyl)-3 methoxyacrylate], in or
on barley, grain from 0.1 parts per million (ppm) to 3.0 ppm and
barley, straw from 4.0 ppm to 7.0 ppm. That notice referenced a summary
of the petition prepared on behalf of IR-4 by Syngenta Crop Protection,
Inc., the registrant, which is available to the public in the docket,
http://www.regulations.gov. There were no comments received in response
to the notice of filing.
    Based upon review of the data supporting these petitions, EPA has
determined that the currently established tolerance in or on barley
bran should also be increased and has

determined that the tolerance expression should be revised. The reasons
for these changes are explained in Unit IV.C.

III. Aggregate Risk Assessment and Determination of Safety

    Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish 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(b)(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.
Section 408(b)(2)(C) of FFDCA 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....''
    Consistent with section 408(b)(2)(D) of FFDCA, and the factors
specified in section 408(b)(2)(D) of FFDCA, EPA has reviewed the
available scientific data and other relevant information in support of
this action. EPA has sufficient data to assess the hazards of and to
make a determination on aggregate exposure for the petitioned-for
tolerances for residues of azoxystrobin on barley bran at 6.0 ppm;
barley grain at 3.0 ppm; and barley straw at 7.0 ppm. EPA's assessment
of exposures and risks associated with establishing tolerances follows.

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered its
validity, completeness, and reliability as well as the relationship of
the results of the studies 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.
    Azoxystrobin has a low acute toxicity via the oral, dermal and
inhalation routes of exposure. It is not an eye or skin irritant and is
not a skin sensitizer. Dietary administration of azoxystrobin to rats
resulted in decreased body weights, decreased food intake and
utilization, increased diarrhea and other clinical toxicity
observations (increased urinary incontinence, hunched postures and
distended abdomens). In dogs, effects on liver/biliary function were
found after oral administration. In the acute neurotoxicity study in
rats, increased incidence of diarrhea was observed at all dose levels
tested including the lowest-observed-adverse-effect-level (LOAEL).
Decreased body weight/weight gain and food utilization was noted in the
rat subchronic neurotoxicity study. There were no consistent
indications of treatment-related neurotoxicity in either the acute or
subchronic neurotoxicity studies.
    In the rat developmental toxicity study, diarrhea, urinary
incontinence and salivation were observed in maternal animals; in the
rabbit developmental toxicity study, maternal animals exhibited
decreased body weight gain. No adverse treatment-related developmental
effects were seen in either study. In the rat reproduction study,
offspring and parental effects (decreased body weights and increased
adjusted liver weights) were observed at the same dose.
    There was no evidence of carcinogenicity in rats and mice at
acceptable dose levels. As a result, EPA has classified azoxystrobin as
``not likely to be carcinogenic to humans.'' Azoxystrobin induced a
weak mutagenic response in the mouse lymphoma assay, but the activity
expressed in vitro is not expected to be expressed in whole animals.
    Specific information on the studies received and the nature of the
adverse effects caused by azoxystrobin as well as the no-observed-
adverse-effect-level (NOAEL) and the LOAEL from the toxicity studies
can be found at http://www.regulations.gov in document ``Azoxystrobin.
Human Health Risk Assessment for a Section 3 Amendment to Reduce the
Preharvest Interval for Barley Grain and Straw and to Add Seed
Treatment Uses on Head and Stem Brassica Vegetables (Subgroup 5A) and
Sorghum, Grain.'', pages 48-51 in docket ID number EPA-HQ-OPP-2009-
0076.

B. Toxicological Endpoints

    For hazards that have a threshold below which there is no
appreciable risk, a toxicological point of departure (POD) is
identified as the basis for derivation of reference values for risk
assessment. The POD may be defined as the highest dose at which no
adverse effects are observed (the NOAEL) in the toxicology study
identified as appropriate for use in risk assessment. However, if a
NOAEL cannot be determined, the lowest dose at which adverse effects of
concern are identified (the LOAEL) or a Benchmark Dose (BMD) approach
is sometimes used for risk assessment. Uncertainty/safety factors (UFs)
are used in conjunction with the POD to take into account uncertainties
inherent in the extrapolation from laboratory animal data to humans and
in the variations in sensitivity among members of the human population
as well as other unknowns. Safety is assessed for acute and chronic
dietary risks by comparing aggregate food and water 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 POD by all applicable UFs. Aggregate short-term,
intermediate-term, and chronic-term risks are evaluated by comparing
food, water, and residential exposure to the POD to ensure that the
margin of exposure (MOE) called for by the product of all applicable
UFs is not exceeded. This latter value is referred to as the Level of
Concern (LOC).
    For non-threshold risks, the Agency assumes that any amount of
exposure will lead to some degree of risk. Thus, the Agency estimates
risk in terms of the probability of an occurrence of the adverse effect
greater than that expected in a lifetime. For more information on the
general principles EPA uses in risk characterization and a complete
description of the risk assessment process, see http://www.epa.gov/
pesticides/factsheets/riskassess.htm.
    A summary of the toxicological endpoints for azoxystrobin used for
human risk assessment can be found at http://www.regulations.gov in
document ``Azoxystrobin. Human Health Risk Assessment for a Section 3
Amendment to Reduce the Preharvest Interval for Barley Grain and Straw
and to Add Seed Treatment Uses on Head and Stem Brassica Vegetables
(Subgroup 5A) and Sorghum, Grain.'', pages 19-20 in docket ID number
EPA-HQ-OPP-2009-0076.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to azoxystrobin, EPA considered exposure under the petitioned-
for tolerances as well as all existing azoxystrobin tolerances in 40
CFR 180.507. EPA assessed dietary exposures from azoxystrobin in food
as follows:
    i. Acute exposure. Quantitative acute dietary exposure and risk
assessments are performed for a food-use pesticide, if a toxicological
study has indicated the possibility of an effect of concern occurring
as a result of a 1-day or single exposure.

    In estimating acute dietary exposure, EPA used food consumption
information from the United States Department of Agriculture (USDA)
1994-1996 and 1998 Nationwide Continuing Surveys of Food Intake by
Individuals (CSFII). As to residue levels in food, EPA used tolerance-
level residues and assumed 100 percent crop treated (PCT).
    ii. Chronic exposure. In conducting the chronic dietary exposure
assessment EPA used the food consumption data from the USDA 1994-1996
and 1998 CSFII. As to residue levels in food, EPA used tolerance-level
residues, incorporated PCT data for some existing uses and assumed 100
PCT for the remaining crops including barley.
    iii. Cancer. Based on the absence of carcinogenicity in two
adequate rodent carcinogenicity studies, EPA has classified
azoxystrobin as ``not likely to be carcinogenic to humans;'' therefore,
a quantitative exposure assessment to evaluate cancer risk is
unnecessary.
    iv. Percent crop treated (PCT) information. Section 408(b)(2)(F) of
FFDCA states that the Agency may use data on the actual percent of food
treated for assessing chronic dietary risk only if:
     Condition a: The data used are reliable and provide a
valid basis to show what percentage of the food derived from such crop
is likely to contain the pesticide residue.
     Condition b: The exposure estimate does not underestimate
exposure for any significant subpopulation group.
     Condition c: Data are available on pesticide use and food
consumption in a particular area, the exposure estimate does not
understate exposure for the population in such area.
    In addition, the Agency must provide for periodic evaluation of any
estimates used. To provide for the periodic evaluation of the estimate
of PCT as required by FFDCA section 408(b)(2)(F), EPA may require
registrants to submit data on PCT.
    The Agency used PCT information as follows:
    Almonds, 25%; apricot, 15%; artichoke, 25%; asparagus, 2.5%;
blackberries, 5%; blueberries, 10%; broccoli, 5%; cabbage, 5%;
cantaloupes, 10%; carrot, 10%; cauliflower, 2.5%; celery, 10%; cherry,
5%; cottonseed, 5%; cucumber, 15%; dried beans/peas, 1%; field corn,
2.5%; filbert (hazelnut), 5%; garlic, 60%; grape, 5%; grapefruit, 25%;
green beans, 5% lettuce, 2.5%; mustard greens, 15%; onion, 10%; orange,
5%; green peas, 2.5%; peach, 5%; peanut, 15%; pecan, 2.5%; pepper, 15%;
pistachio, 20%; potato, 30%; pumpkin, 20%; raspberry, 5%; rice, 35%;
soybean, 2.5%; spinach, 10%; squash, 15%; strawberry, 30%; sugar beets,
5%; sweet corn, 10%; tangerine, 20%; tomato, 15%; walnut, 1%;
watermelon, 20%; and wheat, 2.5%.
    In most cases, EPA uses available data from USDA/National
Agricultural Statistics Service (USDA/NASS), proprietary market
surveys, and the National Pesticide Use Database for the chemical/crop
combination for the most recent 6 years. EPA uses an average PCT for
chronic dietary risk analysis. The average PCT figure for each existing
use is derived by combining available public and private market survey
data for that use, averaging across all observations, and rounding to
the nearest 5%, except for those situations in which the average PCT is
less than one. In those cases, 1% is used as the average PCT and 2.5%
is used as the maximum PCT. EPA uses a maximum PCT for acute dietary
risk analysis. The maximum PCT figure is the highest observed maximum
value reported within the recent 6 years of available public and
private market survey data for the existing use and rounded up to the
nearest multiple of 5%.
    The Agency believes that the three conditions discussed in Unit
III.C.1.iv. have been met. With respect to Condition a, PCT estimates
are derived from Federal and private market survey data, which are
reliable and have a valid basis. The Agency is reasonably certain that
the percentage of the food treated is not likely to be an
underestimation. As to Conditions b and c, regional consumption
information and consumption information for significant subpopulations
is taken into account through EPA's computer-based model for evaluating
the exposure of significant subpopulations including several regional
groups. Use of this consumption information in EPA's risk assessment
process ensures that EPA's exposure estimate does not understate
exposure for any significant subpopulation group and allows the Agency
to be reasonably certain that no regional population is exposed to
residue levels higher than those estimated by the Agency. Other than
the data available through national food consumption surveys, EPA does
not have available reliable information on the regional consumption of
food to which azoxystrobin may be applied in a particular area.
    2. Dietary exposure from drinking water. The Agency used screening
level water exposure models in the dietary exposure analysis and risk
assessment for azoxystrobin in drinking water. These simulation models
take into account data on the physical, chemical, and fate/transport
characteristics of azoxystrobin. Further information regarding EPA
drinking water models used in pesticide exposure assessment can be
found at http://www.epa.gov/oppefed1/models/water/index.htm.
    Based on the First Index Reservoir Screening Tool (FIRST) and
Screening Concentration in Ground Water (SCI-GROW) models, the
estimated drinking water concentrations (EDWCs) of azoxystrobin for
surface water are estimated to be 173 parts per billion (ppb) for acute
exposures and 33 ppb for chronic exposures. For ground water, the
estimated drinking water concentration is 3.1 ppb.
    Modeled estimates of drinking water concentrations were directly
entered into the dietary exposure model. For acute dietary risk
assessment, the water concentration value of 173 ppb was used to assess
the contribution to drinking water. For chronic dietary risk
assessment, the water concentration of value 33 ppb was used to assess
the contribution to drinking water.
    3. From non-dietary exposure. The term ``residential exposure'' is
used in this document to refer to non-occupational, non-dietary
exposure (e.g., for lawn and garden pest control, indoor pest control,
termiticides, and flea and tick control on pets).
    Azoxystrobin is currently registered for the following uses that
could result in residential exposures: Turf grass, ornamentals, indoor
surfaces, and treated paints (preservative incorporation). EPA assessed
residential exposure using the following assumptions: Adults were
assessed for short-term inhalation exposures when mixing, loading and
applying azoxystrobin. For short-term and intermediate-term
postapplication exposures, toddlers and children were assessed for
incidental oral exposure (hand-to-mouth exposure, object-to-mouth
exposure and exposure through incidental ingestion of soil) from
contact with treated foliage and surfaces. Adults were not assessed for
intermediate-term risk, as intermediate-term residential handler
scenarios are not expected to occur. A dermal exposure assessment was
not conducted for residential handlers or for postapplication
activities because no dermal endpoint was identified.
    4. Cumulative effects from substances with a common mechanism of
toxicity. Section 408(b)(2)(D)(v) of 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.''
    EPA has not found azoxystrobin to share a common mechanism of
toxicity with any other substances, and azoxystrobin does not appear to
produce a toxic metabolite produced by other substances. For the
purposes of this tolerance action, therefore, EPA has assumed that
azoxystrobin does not have 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.

D. Safety Factor for Infants and Children

    1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA
shall apply an additional tenfold (10X) 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 database 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 SF. In
applying this provision, EPA either retains the default value of 10X,
or uses a different additional safety factor when reliable data
available to EPA support the choice of a different factor.
    2. Prenatal and postnatal sensitivity. The prenatal and postnatal
toxicity database for azoxystrobin is complete and includes prenatal
developmental toxicity studies in rats and rabbits and a 2-generation
reproduction study in rats. In these studies, offspring toxicity was
observed at equivalent or higher doses than those resulting in parental
toxicity; thus, there is no evidence of increased susceptibility and
there are no residual uncertainties with regard to prenatal and/or
postnatal toxicity.
    3. Conclusion. EPA has reduced the FQPA SF to 3X in assessing acute
dietary risk. An additional safety factor is needed for acute risk
assessment to account for the use of a LOAEL from the acute
neurotoxicity study in rats in deriving the acute reference dose used
for assessing acute dietary exposure for all populations including
infants and children. EPA has determined that reliable data show that
it would be safe for infants and children to reduce the FQPA safety
factor to 1X. To account for the use of a LOAEL from the acute
neurotoxicity study in rats the Agency believes that a 3X FQPA SF (as
opposed to a 10X) will be adequate to extrapolate a NOAEL in assessing
acute risk and that no additional safety factor is needed for short-
term, intermediate-term, and chronic risk assessment based on the
following considerations:
    i. The concern is low for the use of a LOAEL to extrapolate a
NOAEL, given the relatively insignificant nature of the effect
(transient diarrhea seen in the rat); the fact that diarrhea was only
seen in studies involving gavage dosing in the rat but not in repeat
dosing through dietary administration in rats, mice, rabbits, and dogs;
the very high dose level needed to reach the acute oral lethal dose
(LD)50 (>5000 milligrams/kilogram (mg/kg)), and the overall
low toxicity of azoxystrobin. NOAELs were used for short-term,
intermediate-term, and chronic risk assessments.
    ii. The toxicity database for azoxystrobin is complete except for
immunotoxicity testing. Recent changes to 40 CFR part 158 make
immunotoxicity testing (OPPTS Guideline 870.7800) required for
pesticide registration; however, the existing data are sufficient for
endpoint selection for exposure/risk assessment scenarios, and for
evaluation of the requirements under the FQPA. There are no indications
in the available studies that organs associated with immune function,
such as the thymus and spleen, are affected by azoxystrobin and
azoxystrobin does not belong to a class of chemicals (e.g., the
organotins, heavy metals, or halogenated aromatic hydrocarbons) that
would be expected to be immunotoxic. Based on the above considerations
in this unit, EPA does not believe that conducting the immunotoxicity
study will result in a dose less than the point of departure already
used in this risk assessment, and an additional database uncertainty
factor for potential immunotoxicity does not need to be applied.
    iii. Clinical signs noted in the acute and subchronic neurotoxicity
studies were not considered treatment related because of a lack of
dose-response, inconsistency of observations at different time points,
variability of pretreatment values and/or small magnitude of response.
There is no need for a developmental neurotoxicity study or additional
UFs to account for neurotoxicity.
    iv. There is no evidence that azoxystrobin results in increased
susceptibility to in utero rats or rabbits in the prenatal
developmental studies or in young rats in the 2-generation reproduction
study.
    v. The acute and chronic dietary exposure assessments were
performed based on tolerance-level residues. The acute dietary
assessment incorporated 100 PCT information, and the chronic dietary
exposure assessment was somewhat refined using PCT information for
selected crops. EPA made conservative (protective) assumptions in the
ground and surface water modeling used to assess exposure to
azoxystrobin in drinking water. EPA used similarly conservative
assumptions to assess postapplication exposure of children as well as
incidental oral exposure of toddlers. These assessments will not
underestimate the exposure and risks posed by azoxystrobin.

E. Aggregate Risks and Determination of Safety

    EPA determines whether acute and chronic pesticide exposures are
safe by comparing aggregate exposure estimates to the aPAD and cPAD.
The aPAD and cPAD represent the highest safe exposures, taking into
account all appropriate SFs. EPA calculates the aPAD and cPAD by
dividing the POD by all applicable UFs. For linear cancer risks, EPA
calculates the probability of additional cancer cases given the
estimated aggregate exposure. Short-term, intermediate-term, and
chronic-term risks are evaluated by comparing the estimated aggregate
food, water, and residential exposure to the POD to ensure that the MOE
called for by the product of all applicable UFs is not exceeded.
    1. Acute risk. An acute aggregate risk assessment takes into
account exposure estimates from acute dietary consumption of food and
drinking water. Using the exposure assumptions discussed in this unit
for acute exposure, the acute dietary exposure from food and water to
azoxystrobin will occupy 70% of the aPAD for children 1-2 years old,
the population group receiving the greatest exposure.
    2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that chronic exposure to
azoxystrobin from food and water will utilize 9.6% of the cPAD for
children 1-2 years old, the population group receiving the greatest
exposure. Based on the explanation in Unit III.C.3., regarding
residential use patterns, chronic residential exposure to residues of
azoxystrobin is not expected.
    3. Short-term and intermediate-term risk. Short-term and
intermediate-term aggregate exposure takes into account short-term and
intermediate-term residential exposure plus chronic exposure to food
and water (considered to be a background exposure level). Azoxystrobin
is currently registered for uses that could result in short-term and
intermediate-term residential exposure and the Agency has determined
that it

is appropriate to aggregate chronic exposure through food and water
with short-term and intermediate-term residential exposures to
azoxystrobin.
    Using the exposure assumptions described in this unit for short-
term and intermediate-term exposures, EPA has concluded the combined
short-term food, water, and residential exposures result in an
aggregate MOE of 240 for children 1-2 years old (the population group
receiving the greatest exposure), and has concluded the combined
intermediate-term food, water, and residential exposures result in an
aggregate MOE of 340 for children 1-2 years old (the population group
receiving the greatest intermediate-term exposure). As the aggregate
MOEs for short-term and intermediate-term exposure are greater than 100
(the LOC) for all population subgroups assessed, short-term and
intermediate-term aggregate exposures to azoxystrobin are not of
concern to EPA.
    4. Aggregate cancer risk for U.S. population. Based on the lack of
evidence of carcinogenicity in mice and rats in two adequate
carcinogenicity studies, azoxystrobin was classified as ``not likely to
be carcinogenic to humans,'' and is not expected to pose a cancer risk
to humans.
    5. 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 azoxystrobin residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodologies are available to enforce the
tolerance expression and have been submitted to FDA for inclusion in
the Pesticide Analytical Manual (PAM) Volume II: A gas chromatography
method with nitrogen-phosphorus detection (GC/NPD), RAM 243/04, for the
enforcement of tolerances for residues of azoxystrobin and its Z-isomer
in crop commodities; and a GC/NPD method, RAM 255/01, for the
enforcement of tolerances of azoxystrobin in livestock commodities. The
method may be requested from: Chief, Analytical Chemistry Branch,
Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD 20755-5350;
telephone number:<PHONE_NUMBER>; e-mail address:
<EMAIL_ADDRESS>
B. International Residue Limits

    Codex Maximum Residue Limits (MRLs) have been established for
azoxystrobin in or on barley grain at 0.5 ppm; and straw and fodder of
cereal grains (except maize) at 15 ppm. The Codex MRLs for barley grain
and straw are based on field trials conducted in Europe and on residues
present at a 35-42 day pre-harvest interval (PHI). The recommended U.S.
tolerances on barley grain (3.0 ppm) and straw (7.0 ppm) are based on
residues present at a 14-day PHI. The U.S. tolerance for barley grain
is higher due to the shorter PHI; thus, the barley grain tolerance and
MRLs cannot be harmonized between the U.S. and Codex. Codex MRLs for
forages, straws and the like are set on a dry-weight basis, whereas
U.S. tolerances are set on an as-fed basis; therefore, the U.S.
tolerance on barley straw cannot be harmonized with the Codex MRL for
straw and fodder of cereal grains (including barley, oats, rice and
wheat data) at this time.

C. Revisions to Petitioned-For Tolerances

    Based upon review of the data supporting the petition, EPA has
revised the existing tolerance for barley bran from 0.2 ppm to 6.0 ppm.
Based on previously-submitted wheat processing data, a tolerance for
barley bran was established at 0.2 ppm; however, the proposed PHI
reduction for barley grain results in higher residues in barley grain
and the potential for increased residues in barley bran. Using the
highest average field trial data for barley grain harvested at the 14-
day PHI (1.85 ppm) and the concentration factor for wheat bran (3x),
expected residues in barley bran would be 5.55 ppm. The expected barley
bran residues exceed the proposed tolerance increase for barley grain
at 3.0 ppm and the existing tolerance for barley bran at 0.2 ppm.
Therefore, the Agency is increasing the established tolerance for
azoxystrobin in or on barley bran from 0.2 ppm to 6.0 ppm.
    Additionally, EPA has revised the tolerance expression to clarify:
    1. That, as provided in FFDCA section 408(a)(3), the tolerance
covers metabolites and degradates of azoxystrobin not specifically
mentioned; and
    2. That compliance with the specified tolerance levels is to be
determined by measuring only the specific compounds mentioned in the
tolerance expression. This change was made to both the tolerance
expressions for plant commodities and animal commodities because it
makes no substantive change to the meaning of the tolerance but rather
only clarifies the existing language.

V. Conclusion

    Therefore, established tolerances are amended for residues of
azoxystrobin, [methyl( E )-2-(2-(6-(2-cyanophenoxy) pyrimidin-4-
yloxy)phenyl)-3-methoxyacrylate] and the Z-isomer of azoxystrobin,
[methyl( Z )-2-(2-(6-(2-cyanophenoxy)pyrimidin-4-yloxy)phenyl)-3
methoxyacrylate], in or on barley, bran at 6.0 ppm; barley, grain at
3.0 ppm; and barley, straw at 7.0 ppm.

VI. Statutory and Executive Order Reviews

    This final rule establishes tolerances 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 final rule is
not subject to Executive Order 13211, entitled 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 9, 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).

VII. 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: October 7, 2009.
Lois Rossi,
Director, Registration 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 180.507 is amended in paragraph (a)(1) by revising the
introductory text and by revising the entries for ``Barley, bran'';
``Barley, grain''; and ``Barley, straw'' in the table; and in paragraph
(a)(2) by revising the introductory text to read as follows:

Sec.  180.507  Azoxystrobin; tolerances for residues.

    (a) General. (1) Tolerances are established for residues of the
fungicide, azoxystrobin, including its metabolites and degradates, in
or on the commodities in the following table. Compliance with the
tolerance levels specified in the table is to be determined by
measuring only the sum of azoxystrobin, [methyl( E )-2-(2-(6-(2-
cyanophenoxy) pyrimidin-4-yloxy)phenyl)-3-methoxyacrylate], and the Z-
isomer of azoxystrobin [methyl( Z )-2-(2-(6-(2-cyanophenoxy)pyrimidin-
4-yloxy)phenyl)-3 methoxyacrylate] in or on the commodity.

------------------------------------------------------------------------
                      Commodity                        Parts per million
------------------------------------------------------------------------
                                * * * * *
Barley, bran.........................................                6.0
                                * * * * *
Barley, grain........................................                3.0
                                * * * * *
Barley, straw........................................                7.0
                                * * * * *
------------------------------------------------------------------------

    (2) Tolerances are established for residues of the fungicide,
azoxystrobin, including its metabolites and degradates, in or on the
commodities in the following table. Compliance with the tolerance
levels specified in the table is to be determined by measuring only the
sum of azoxystrobin, [methyl( E )-2-(2-(6-(2-cyanophenoxy) pyrimidin-4-
yloxy)phenyl)-3-methoxyacrylate], and the Z-isomer of azoxystrobin
[methyl( Z )-2-(2-(6-(2-cyanophenoxy)pyrimidin-4-yloxy)phenyl)-3
methoxyacrylate] in or on the commodity.
* * * * *

[FR Doc. E9-24813 Filed 10-15-09; 8:45 am]

BILLING CODE 6560-50-S