[Federal Register: January 22, 2010 (Volume 75, Number 14)]
[Notices]
[Page 3738-3739]
[DOCID:fr22ja10-58]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-N-0246]

Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Establishing and
Maintaining a List of U.S. Dairy Product Manufacturers/Processors With
Interest in Exporting to Chile

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice.

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SUMMARY:  The Food and Drug Administration (FDA) is announcing that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995.

DATES: Fax written comments on the collection of information by
February 22, 2010.

ADDRESSES:  To ensure that comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer,
FAX:<PHONE_NUMBER>, or e-mailed to<EMAIL_ADDRESS>All
comments should be identified with the OMB control number 0910-0509.
Also include the FDA docket number found in brackets in the heading of
this document.

FOR FURTHER INFORMATION CONTACT: Denver Presley Jr., Office of
Information Management (HFA-710), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.

Establishing and Maintaining a List of U.S. Dairy Product
Manufacturers/Processors With Interest in Exporting to Chile (OMB
Control Number 0910-0509)--Extension

    As a direct result of discussions that have been adjunct to the
U.S./Chile Free Trade Agreement, Chile has recognized FDA as the
competent U.S. food safety authority and has accepted the U.S.
regulatory system for dairy inspections. Chile has concluded that it
will not require individual inspections of U.S. firms by Chile as a
prerequisite for trade, but will accept firms identified by FDA as
eligible to export to Chile. Therefore, in the Federal Register of June
22, 2005 (70 FR 36190), FDA announced the availability of a revised
guidance document entitled ``Establishing and Maintaining a List of
U.S. Dairy Product Manufacturers/Processors With Interest in Exporting
to Chile.'' The guidance can be found at http://www.cfsan.fda.gov/
guidance.html. The guidance document explains that FDA has established
a list that is provided to the government of Chile and posted on http:/
/

www.cfsan.fda.gov/~comm/expcllst.html, which identifies U.S. dairy
product manufacturers/processors that have expressed interest to FDA in
exporting dairy products to Chile, are subject to FDA jurisdiction, and
are not the subject of a pending judicial enforcement action (i.e., an
injunction or seizure) or a pending warning letter. The term ``dairy
products,'' for purposes of this list, is not intended to cover the raw
agricultural commodity raw milk. Application for inclusion on the list
is voluntary. However, Chile has advised that dairy products from firms
not on this list could be delayed or prevented by Chilean authorities
from entering commerce in Chile. The guidance explains what information
firms should submit to FDA in order to be considered for inclusion on
the list and what criteria FDA intends to use to determine eligibility
for placement on the list. The document also explains how FDA intends
to update the list and how FDA intends to communicate any new
information to Chile. Finally, the guidance notes that FDA considers
the information on this list, which is provided voluntarily with the
understanding that it will be posted on FDA's Web site and communicated
to, and possibly further disseminated by, Chile, to be information that
is not protected from disclosure under 5 U.S.C. 552(b)(4). Under the
guidance, FDA recommends that U.S. firms that want to be placed on the
list send the following information to FDA: (1) Name and address of the
firm and the manufacturing plant; (2) name, telephone number, and e-
mail address (if available) of the contact person; (3) a list of
products presently shipped and expected to be shipped in the next 3
years; (4) identities of agencies that inspect the plant and the date
of last inspection; (5) plant number and copy of last inspection
notice; and (6) if other than an FDA inspection, copy of last
inspection report. FDA requests that this information be updated every
2 years.
    In the Federal Register of June 4, 2009 (74 FR 26867), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. FDA received two letters in response, each
containing one or more comments. The comments were outside the scope of
the comment request in the notice.
    FDA estimates the burden of this collection of information as
follows:

                                 Table 1.--Estimated Annual Reporting Burden\1\
----------------------------------------------------------------------------------------------------------------
                    No. of        Annual Frequency      Total Annual
  Activity       Respondents        per Response          Responses       Hours per  Response     Total Hours
----------------------------------------------------------------------------------------------------------------
New written                  15                  1                    15                  1.5                 23
 requests to
 be placed
 on the list
----------------------------------------------------------------------------------------------------------------
Biannual                     88                  1                    88                  1.0                 88
 update
----------------------------------------------------------------------------------------------------------------
Occasional                   25                  1                    25                  0.5                 13
 updates
----------------------------------------------------------------------------------------------------------------
Total                                                                                124
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital or operating and maintenance costs associated with this collection of information.

    The estimate of the number of firms that will submit new written
requests to be placed on the list, biannual updates and occasional
updates is based on the FDA's experience maintaining the list over the
past 4 years. The estimate of the number of hours that it will take a
firm to gather the information needed to be placed on the list or
update its information is based on FDA's experience with firms
submitting similar requests. FDA believes that the information to be
submitted will be readily available to the firms.
    To date, over 175 producers have sought to be included on the list.
FDA estimates that, each year, approximately 15 new firms will apply to
be added to the list. We estimate that a firm will require 1.5 hours to
read the guidance, gather the information needed, and to prepare a
communication to FDA that contains the information and requests that
the firm be placed on the list for a total of 22.5 hours, rounded to
23. Under the guidance, every 2 years each producer on the list must
provide updated information in order to remain on the list. FDA
estimates that each year approximately half of the firms on the list,
88 firms (175 x 0.5 = 87.5, rounded to 88), will resubmit the
information to remain on the list. We estimate that a firm already on
the list will require 1.0 hours to biannually update and resubmit the
information to FDA, including time reviewing the information and
corresponding with FDA, for a total of 88 hours. In addition, FDA
expects that, each year, approximately 25 firms will need to submit an
occasional update and each firm will require 0.5 hours to prepare a
communication to FDA reporting the change, for a total of 12.5 hours,
rounded to 13.

    Dated: January 15, 2010.
David Dorsey
Acting Deputy Commissioner for Policy, Planning and Budget.
[FR Doc. 2010-1153 Filed 1-21-10; 8:45 am]
BILLING CODE 4160-01-S


[Federal Register Volume 80, Number 121 (Wednesday, June 24, 2015)]
[Rules and Regulations]
[Pages 36239-36242]
[FR Doc No: 2015-15458]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R03-OAR-2014-0886; FRL-9929-40-Region-3]

Approval and Promulgation of Air Quality Implementation Plans;
Pennsylvania; Revision to Allegheny County Regulations for Establishing
Permit Fees

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: The Environmental Protection Agency (EPA) is approving a State
Implementation Plan (SIP) revision submitted by the Commonwealth of
Pennsylvania. This revision pertains to the Air Pollution Control
portion of the Allegheny County Health Department (ACHD) rules and
regulations and consists of changes to the regulations establishing
installation permit application and administration fees and open
burning permit application fees. EPA is approving these revisions to
Pennsylvania's SIP in accordance with the requirements of the Clean Air
Act (CAA).

DATES: This final rule is effective on July 24, 2015.

ADDRESSES: EPA has established a docket for this action under Docket ID
Number EPA-R03-OAR-2014-0886. All documents in the docket are listed in
the www.regulations.gov Web site. Although listed in the electronic
docket, some information is not publicly available, i.e., 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 electronically through www.regulations.gov or in hard
copy for public inspection during normal business hours at the Air
Protection Division, U.S. Environmental Protection Agency, Region III,
1650 Arch Street, Philadelphia, Pennsylvania 19103. Copies of the State
submittal are available at the Pennsylvania Department of Environmental
Protection, Bureau of Air Quality Control, P.O. Box 8468, 400 Market
Street, Harrisburg, Pennsylvania 17105; Allegheny County Health
Department, Bureau of Environmental Quality, Division of Air Quality,
301 39th Street, Pittsburgh, Pennsylvania 15201.

FOR FURTHER INFORMATION CONTACT: Paul T. Wentworth, P.E. at: (215) 814-
2183, or by email at<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    On March 9, 2015 (80 FR 12374), EPA published a document in the
Federal Register (NPR) proposing to approve the August 30, 2010 SIP
revision submittal from the Commonwealth of Pennsylvania through the
Pennsylvania Department of Environmental Protection (PADEP). The SIP
revision pertains to the Air Pollution Control portion of ACHD's rules
and regulations and consists of changes to the ACHD regulations
establishing installation permit application and administration fees
and open burning permit application fees. EPA received one comment on
the NPR. A summary of the comment and EPA's response are provided in
Section III of this document.

II. Summary of SIP Revision

    The SIP revision consists of changes to ACHD regulations in Article
XXI for installation permit fees and open burning permit fees,
including revisions to section 2102.10, entitled ``Installation Permit
Application and Administration Fees,'' and to section 2105.50, entitled
``Open Burning and Administration Fees.'' The changes replace
provisions containing fixed monetary amounts for permit fees provided
for installation and open burning permits in sections 2102.10 and
2105.5 with language that

provides for the Allegheny County Council to establish the amount of
the given fee based on consideration of the degree of technical and
regulatory difficulty in processing each type of installation permit.
The revisions to Article XXI sections 2102.10 and 2105.50 include new
permit fee provisions for the following permit types: Permits required
by the Prevention of Significant Deterioration regulations; permits
issued for new major sources and for major modifications to sources
locating in or impacting a non-attainment area; permits required by
existing standards, such as the New Source Performance Standards and
the National Emission Standards for Hazardous Air Pollutants; permits
in which ACHD establishes the Maximum Achievable Control Technology for
a source; permits for any source requiring an installation permit but
not subject to any of the previous requirements; and general
installation permits. The specific revisions to requirements in Article
XXI sections 2102.10 and 2105.50 pertaining to fees for installation
and open burning permits in Allegheny County for proposed approval are
explained in the NPR and will not be restated here. See 80 FR at 12374.

III. Public Comments and EPA Responses

    EPA received one anonymous comment on the proposed approval for the
Pennsylvania SIP of revisions to ACHD's regulations. A summary of the
comment and our response follows.
    Comment: The commenter expresses support for the action proposed by
the EPA to include the revised Allegheny County regulations in the
Pennsylvania SIP; however, the commenter states that in section III of
the NPR, EPA's statement that section 110(a)(2)(L)(i) and (ii) requires
SIPs to include fees sufficient to cover the costs of reviewing and
acting upon a permit application is incorrect. The commenter points out
that CAA section 110(a)(2)(L)(i) and (ii) do not require SIPs to
``include'' fees; rather 110(a)(2)(L) states SIPs must require owners
and operators to ``pay'' fees. According to the commenter, if the
statement EPA made was correct, it would mean that the revisions EPA is
acting upon do not satisfy the requirements of section 110(a)(2)(L)(i)
and (ii) because the proposed revisions remove the fixed monetary fee
for certain permits and therefore the SIP would not include a fee and
thus would not meet section 110(a)(2)(L)(i) and (ii). To further
support the argument, the commenter cites the September 13, 2013
Memorandum from Stephen D. Page, Director, Office of Air Quality
Planning and Standards, Guidance on Infrastructure State Implementation
Plan Elements Under CAA Sections 110(a)(1) and 110(a)(2)
(Infrastructure SIP Guidance), in which EPA discusses section
110(a)(2)(L) and states that ``the fee program is not required to be
part of the EPA approved SIP.''
    Response: EPA appreciates the commenter's support for the action
approving this SIP revision. EPA also agrees with the commenter that
fee programs included in SIPs to comply with section 110(a)(2)(L) do
not have to require a specific dollar amount for a permit or other
approval. The Agency also agrees that the ACHD fee program provisions
that we approve into the SIP today are consistent with CAA section
110(a)(2)(L). We do not agree with the commenter's characterization of
the Agency's interpretation of the statute as explained below.
    CAA section 110(a)(2)(L) regarding permit fee requirements for SIPs
provides in pertinent part that the SIP shall ``require the owner and
operator of each major stationary source to pay the permitting
authority, as a condition of any permit required under this chapter, a
fee sufficient to cover'' the reasonable costs of reviewing and acting
on permit applications and the reasonable costs of implementing and
enforcing the terms and conditions of any such permits. Section
110(a)(2)(L) further requires such provisions for SIPs until the major
source fee requirements are superseded with respect to such sources by
EPA's approval of a fee program under Title V of the CAA.\1\
---------------------------------------------------------------------------

    \1\ EPA's Infrastructure SIP Guidance states that the EPA-
approved title V fee program is not required to be included in the
SIP and then refers state air agencies to EPA regional offices to
address section 110(a)(2)(L) requirements for permit fee programs
addressing permits required by Title I of the CAA, such as permits
required upon construction or modification of certain sources.
---------------------------------------------------------------------------

    In the NPR, EPA proposed to approve for the Pennsylvania SIP
certain revisions to Allegheny County's regulations which deleted fixed
fees for certain required installation permits and open burning permits
from the ACHD regulations and replaced such fixed fees with provisions
stating that installation and open burning permit fees required for
owners and operators of certain pollutant emitting stationary sources
would be set by Allegheny County factoring in the degree of technical
and regulatory difficulty for categories of installation permits. EPA
proposed to approve the revisions as meeting requirements for permit
fees in CAA section 110(a)(2)(L). In the proposal, EPA inadvertently
did not include the verbatim text of CAA section 110(a)(2)(L) in
providing the explanation for our proposed approval of Allegheny
County's regulations. However, the revisions to sections 2102.10 and
2105.50 of Article XXI of Allegheny County's regulations satisfy CAA
section 110(a)(2)(L) because the revised provisions in sections 2102.10
and 2015.50 clearly require the owner and operator of certain air
pollutant-emitting sources to pay to Allegheny County, the local
permitting authority, a fee sufficient to cover reasonable costs to
review and act upon permit applications and reasonable costs for
Allegheny County to implement and enforce permit terms and conditions.
The revisions to sections 2102.10 and 2105.50 simply remove a fixed
monetary fee that owners and operators of certain sources would need to
pay for installation and open burning permits and replace the fixed fee
with applicable criteria for Allegheny County to determine the value of
the fee for owners or operators to obtain required installation and
open burning permits. The provisions of Allegheny County's regulations
still require the payment of a fee for certain installation and open
burning permits which would meet requirements in section 110(a)(2)(L)
for SIPs to include provisions for payment of such fees.
    EPA is unsure of the relevance of the quote from EPA's
Infrastructure SIP Guidance included in the comment. The Infrastructure
SIP Guidance at pages 56-57 states: ``Currently, every state has an
EPA-approved fee program under CAA Title V. However, the fee program is
not required to be part of the EPA approved SIP.'' This language
clearly refers to the EPA-approved fee program under CAA Title V for
operating permits required by Title V of the CAA which may supersede
certain requirements for SIPs to include fee requirements for permits
required by the CAA. Pennsylvania has an EPA-approved Title V program
and an EPA-approved Title V fee program, but the Allegheny County
regulations we proposed to approve in the NPR are not part of the
Pennsylvania Title V program. Sections 2102.10 and 2105.50 of Article
XXI of Allegheny County's regulations relate to fees for certain
installation and open burning permits which are required by Allegheny
County prior to installation of certain pollutant emitting sources or
open burning operations. Such permits are required by Allegheny County
to implement requirements in Title I of the CAA, not Title V. These
fees provide funds for Allegheny County to review, implement and
enforce permits required

by Title I of the CAA that are not funded under the state's Title V
permit program. Thus, the language of the Infrastructure SIP Guidance
included in the comment is not applicable to this action. EPA proposed
in the NPR to approve the revisions to sections 2102.10 and 2105.50 of
Article XXI because the regulations require owners or operators of
certain stationary sources to pay permit fees as a precondition to
receiving an installation or open burning permit. These regulations
therefore satisfy requirements in section 110(a)(2)(L) that the SIP
require owners and operators to pay the permitting authority a fee
sufficient to cover reasonable costs of reviewing, acting on,
implementing and enforcing permits required by the CAA, including
installation or construction permits required by Title I of the CAA.

IV. Final Action

    EPA is approving as a revision to the Pennsylvania SIP the August
30, 2010 SIP submittal from PADEP consisting of changes to the ACHD
regulations establishing installation permit application and
administration fee requirements and open burning permit application fee
requirements in Allegheny County.

V. Incorporation by Reference

    In this, the EPA is finalizing regulatory text that includes
incorporation by reference. In accordance with requirements of 1 CFR
51.5, the EPA is finalizing the incorporation by reference of the
Allegheny County Regulations described in the amendments to 40 CFR part
52 set forth below. The EPA has made, and will continue to make, these
documents generally available electronically through
www.regulations.gov and/or in hard copy at the appropriate EPA office
(see the ADDRESSES section of this preamble for more information).

VI. Statutory and Executive Order Reviews

A. General Requirements

    Under the CAA, the Administrator is required to approve a SIP
submission that complies with the provisions of the CAA and applicable
Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in
reviewing SIP submissions, EPA's role is to approve state choices,
provided that they meet the criteria of the CAA. Accordingly, this
action merely approves state law as meeting Federal requirements and
does not impose additional requirements beyond those imposed by state
law. For that reason, this action:
     Is not a ``significant regulatory action'' subject to
review by the Office of Management and Budget under Executive Order
12866 (58 FR 51735, October 4, 1993);
     does not impose an information collection burden under the
provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);
     is certified as not having a significant economic impact
on a substantial number of small entities under the Regulatory
Flexibility Act (5 U.S.C. 601 et seq.);
     does not contain any unfunded mandate or significantly or
uniquely affect small governments, as described in the Unfunded
Mandates Reform Act of 1995 (Pub. L. 104-4);
     does not have Federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999);
     is not an economically significant regulatory action based
on health or safety risks subject to Executive Order 13045 (62 FR
19885, April 23, 1997);
     is not a significant regulatory action subject to
Executive Order 13211 (66 FR 28355, May 22, 2001);
     is not subject to requirements of Section 12(d) of the
National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272
note) because application of those requirements would be inconsistent
with the CAA; and
     does not provide EPA with the discretionary authority to
address, as appropriate, disproportionate human health or environmental
effects, using practicable and legally permissible methods, under
Executive Order 12898 (59 FR 7629, February 16, 1994).
    In addition, this rule does not have tribal implications as
specified by Executive Order 13175 (65 FR 67249, November 9, 2000),
because the SIP is not approved to apply in Indian country located in
the state, and EPA notes that it will not impose substantial direct
costs on tribal governments or preempt tribal law.

B. Submission to Congress and the Comptroller General

    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States. EPA will submit a report containing this action 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 the rule in the Federal Register. A major rule cannot
take effect until 60 days after it is published in the Federal
Register. This action is not a ``major rule'' as defined by 5 U.S.C.
804(2).

C. Petitions for Judicial Review

    Under section 307(b)(1) of the CAA, petitions for judicial review
of this action must be filed in the United States Court of Appeals for
the appropriate circuit by August 24, 2015. Filing a petition for
reconsideration by the Administrator of this final rule does not affect
the finality of this action for the purposes of judicial review nor
does it extend the time within which a petition for judicial review may
be filed, and shall not postpone the effectiveness of such rule or
action. This action pertaining to the Air Pollution Control portion of
the Allegheny County Rules and Regulations, which revises the
regulations establishing installation permit application and
administration fees, as well as open burning permit application fees
may not be challenged later in proceedings to enforce its requirements.
(See section 307(b)(2).)

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Carbon monoxide,
Incorporation by reference, Intergovernmental relations, Lead, Nitrogen
dioxide, Ozone, Particulate matter, Reporting and recordkeeping
requirements, Sulfur oxides, Volatile organic compounds.

    Dated: June 11, 2015.
William C. Early,
Acting Regional Administrator, Region III.

    40 CFR part 52 is amended as follows:

PART 52--APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS

0
1. The authority citation for part 52 continues to read as follows:

    Authority: 42 U.S.C. 7401 et seq.

Subpart NN--Pennsylvania

0
2. In Sec.  52.2020, the table in paragraph (c)(2) is amended by:
0
a. Under Part B, revising the entry for ``2102.10''; and
0
b. Under Part E, subpart 5, revising the entry for ``2105.50''.
    The revisions read as follows:

Sec.  52.2020  Identification of plan.

* * * * *
    (c) * * *
    (2) * * *

----------------------------------------------------------------------------------------------------------------
                                                            State                                 Additional
   Article XX or XXI citation         Title/Subject       effective     EPA Approval date     explanation/ Sec.
                                                             date                              52.2063 citation
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------
                                            Part B--Permits Generally
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
2102.10.........................  Installation Permit      7/26/2009  6/24/2015 [Insert
                                   Application And                     Federal Register
                                   Administration Fees.                citation].

                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------
                                 Part E--Source Emission and Operating Standards
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------
                              Subpart 5--Open Burning and Abrasive Blasting Sources
----------------------------------------------------------------------------------------------------------------
2105.50 (except paragraph .50.d)  Open Burning.........    7/26/2009  6/24/2015 [Insert
                                                                       Federal Register
                                                                       citation].

                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------

* * * * *
[FR Doc. 2015-15458 Filed 6-23-15; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register Volume 77, Number 45 (Wednesday, March 7, 2012)]
[Rules and Regulations]
[Pages 13502-13506]
[FR Doc No: 2012-5271]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2010-0659; FRL-9336-6]

Pyriofenone; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of
pyriofenone, (5-chloro-2-methoxy-4-methyl-3-pyridinyl)(2,3,4-
trimethoxy-6-methylphenyl) methanone, including its metabolites and
degradates, in or on grape and grape, raisin. ISK BioSciences
Corporation requested these tolerances under the Federal Food, Drug,
and Cosmetic Act (FFDCA).

DATES: This regulation is effective March 7, 2012. Objections and
requests for hearings must be received on or before May 7, 2012, 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-2010-0659. 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: Heather Garvie, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone
number:<PHONE_NUMBER>; email 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 get electronic access to other related information?

    You may access a frequently updated electronic version of EPA's
tolerance regulations at 40 CFR part 180 through the Government
Printing Office's e-CFR site at http://ecfr.gpoaccess.gov/cgi/t/text/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.

C. How can I file an objection or hearing request?

    Under FFDCA section 408(g), 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-2010-0659 in the subject line on the first
page of your submission. All objections and requests for a hearing must
be in writing, and must be received by the Hearing Clerk on or before
May 7, 2012. Addresses for mail and hand delivery of objections and
hearing requests are provided in 40 CFR 178.25(b).
    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. Information not marked confidential pursuant to 40 CFR part 2
may be disclosed publicly by EPA without prior notice. Submit a copy of
your non-CBI objection or hearing request, identified by docket ID
number EPA-HQ-OPP-2010-0659, 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. Summary of Petitioned-For Tolerance

    In the Federal Register of September 8, 2010 (75 FR 54629) (FRL-
8843-3), 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
0E7731) by ISK BioSciences Corporation, 7470 Auburn Rd., Suite A,
Concord, OH 44077. The petition requested that 40 CFR part 180 be
amended by establishing a tolerance for residues of the fungicide
pyriofenone (5-chloro-2-methoxy-4-methyl-3-pyridinyl)(2,3,4-trimethoxy-
6-methylphenyl) methanone, in or on grape at 0.2 parts per million
(ppm).
    That notice referenced a summary of the petition prepared by ISK
BioSciences Corporation, the registrant, which is available 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 the petition, EPA has
modified the petitioned for tolerance for pyriofenone by increasing the
tolerance level for grape and establishing a separate tolerance for
grape, raisin. The reasons for these changes are explained in Unit
IV.D.
    These are the first tolerances established for pyriofenone. There
are no registered uses for pyriofenone in the United States. The
tolerances were requested in connection with use of pyriofenone on
grapes grown overseas. These tolerances will allow grapes and processed
grape commodities containing pyriofenone residues to be imported to the
United States.

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 FFDCA section 408(b)(2)(D), and the factors
specified in FFDCA section 408(b)(2)(D), 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 pyriofenone including exposure
resulting from the tolerances established by this action. EPA's
assessment of exposures and risks associated with pyriofenone 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. The liver and kidney were affected by treatment with
pyriofenone, and although more effects were noted with increasing
duration of exposure, effects were generally not severe. These effects
included increased liver weight, microscopic changes, and clinical
chemistry changes in rats, mice, and/or dogs. Kidney effects included
increased organ weight, microscopic changes, and clinical chemistry
changes in rats and mice and an increased incidence of chronic
nephropathy in rats. Clinical signs included vomiting and loose stools
in dogs and peri-genital staining in mice. Also noted were skin changes
in the 2-year rat study (atrophy of hair follicles or perifolliculitis)
and increased cecal weight or distended cecum in rat studies.
Mutagenicity and carcinogenicity testing was negative and the cancer
classification for pyriofenone is ``not likely to be carcinogenic to
humans'' and therefore there is no cancer risk associated with exposure
to pyriofenone.
    No developmental or reproductive toxicity occurred in the rat
studies. Abortions were noted in the rabbit developmental study and
were associated with decreased maternal body weight gain and food
consumption. There was no evidence of neurotoxicity and a developmental
neurotoxicity study is not needed for pyriofenone. Immunotoxicity
testing in rats and mice was negative. Pyriofenone has a low acute
toxicity by the oral exposure route. Dermal toxicity, inhalation
toxicity, and ocular irritation studies are not available because these
exposure routes are not applicable to non-domestic uses. Specific
information on the studies received and the nature of the adverse
effects caused by pyriofenone as well as the no-observed-adverse-
effect-level (NOAEL) and the lowest-observed-adverse-effect-level
(LOAEL) from the toxicity studies can be found at http://www.regulations.gov in document ``Pyriofenone. Human-Health Risk
Assessment for the Establishment of Tolerances for Pyriofenone
Fungicide in/on Imported Grapes,'' dated November 1, 2011 at pp. 16-30
in docket ID number EPA-HQ-OPP-2010-0659.

B. Toxicological Points of Departure/Levels of Concern

    Once a pesticide's toxicological profile is determined, EPA
identifies toxicological points of departure (POD) and levels of
concern to use in evaluating the risk posed by human exposure to the
pesticide. For hazards that have a threshold below which there is no
appreciable risk, the toxicological POD is used as the basis for
derivation of reference values for risk assessment. PODs are developed
based on a careful analysis of the doses in each toxicological study to
determine the dose at which no adverse effects are observed (the NOAEL)
and the lowest dose at which adverse effects of concern are identified
(the LOAEL). Uncertainty/safety factors are used in conjunction with
the POD to calculate a safe exposure level--generally referred to as a
population-adjusted dose (PAD) or a reference dose (RfD)--and a safe
margin of exposure (MOE). 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 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 used for human risk assessment is shown in the Table of
this unit.
    In risk assessments for import commodities, endpoints are typically
selected for dietary exposure only. Endpoints for incidental oral,
dermal, and inhalation exposures are not

selected for import tolerances due to lack of potential occupational or
residential exposure. No adverse effects attributable to a single
exposure were identified for pyriofenone; therefore, an acute dietary
endpoint was not selected for pyriofenone.
    Consideration was given to selecting abortions/premature delivery
from the rabbit developmental study as an endpoint for assessing acute
dietary risk. Typically, abortions observed early in the pregnancy in a
developmental toxicity study are assumed to be attributable to a single
exposure and thus appropriate for acute dietary risk assessment.
    In the rabbit developmental toxicity study, abortions occurred in 2
does on gestation day 18 at the highest dose tested (300 milligram/
kilogram/day (mg/kg/day). In this case the abortions were determined
not to be attributable to a single exposure since the abortions
occurred late in gestation (GD 18) and prior to which both does had
significantly lower-food consumption resulting in lower body weight or
body weight gain. In the range-finding study, abortions and premature
delivery seen in 2 does also showed an association to the lower body
weight and food consumption. Thus, the potential nutrient deficiency
and maternal toxicity resulting from loss in body weight and lower food
consumption were assumed to result in the abortions/premature delivery
rather than the test compound.
    For the chronic dietary risk assessment, a NOAEL of 9 mg/kg/day was
selected based on the increased incidence of chronic nephropathy seen
in female rats at 46 mg/kg/day (LOAEL) in the 2-year carcinogenicity
study. Typically, chronic nephropathy occurs as spontaneous lesions in
geriatric rats and in some cases, exposure to a chemical may exacerbate
this kidney lesion. In this case, however, chronic nephropathy was
considered to be adverse because the incidences of this lesion was
significantly increased in females at 46 mg/kg/day (30/35) and also at
the next higher dose of 254 mg/kg/day (36/45, p<0.005). In the chronic
study with dogs, the effects (e.g., clinical signs, alterations in
clinical pathology, organ weights, or histopathology) were determined
to be not adverse since the findings were isolated, highly variable,
and/or there was a lack of dose-response or a clear target organ for
toxicity.

   Table--Summary of Toxicological Doses and Endpoints for Pyriofenone for Use in Human Health Risk Assessment
----------------------------------------------------------------------------------------------------------------
                                        Point of departure and
          Exposure/scenario               uncertainty/safety     RfD, PAD, LOC for risk  Study and toxicological
                                               factors                 assessment                 effects
----------------------------------------------------------------------------------------------------------------
Acute dietary........................  An acute dietary endpoint was not selected because toxicity from a single
                                        dose was not identified in the hazard database.
----------------------------------------------------------------------------------------------------------------
Chronic dietary (All populations)....  NOAEL= 9 mg/kg/day.....  Chronic RfD = 0.09.....  Chronic toxicity/
                                       UFA = 10x..............  mg/kg/day..............   carcinogenicity study--
                                       UFH = 10x..............  cPAD = 0.09............   rat
                                       FQPA SF = 1x...........  mg/kg/day..............  NOAEL = 9 mg/kg/day
                                                                                based on increased
                                                                                nephropathy seen in
                                                                                female rats at LOAEL =
                                                                                46 mg/kg/day.
                                      --------------------------------------------------------------------------
Cancer (Oral, dermal, inhalation)....  Classification: ``Not likely to be Carcinogenic to Humans''.
----------------------------------------------------------------------------------------------------------------
FQPA SF = FQPA Safety Factor. LOAEL = lowest observed adverse effect level.
LOC = Level of Concern. mg/kg/day = milligram/kilogram/day. NOAEL = no observed adverse effect level. PAD =
  population adjusted dose (a = acute, c = chronic). RfD = reference dose. UFA = extrapolation from animal to
  human (intraspecies). UFH = potential variation in sensitivity among members of the human population
  (interspecies).

    Specific information on the toxicological endpoints for pyriofenone
can be found at http://www.regulations.gov in document ``Pyriofenone.
Human-Health Risk Assessment for the Establishment of Tolerances for
Pyriofenone Fungicide in/on Imported Grapes,'' dated November 1, 2011
at pp.16-30 in docket ID number EPA-HQ-OPP-2010-0659.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to pyriofenone, EPA considered exposure under the petitioned-
for tolerances. EPA assessed dietary exposures from pyriofenone 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. No such effects were
identified in the toxicological studies for pyriofenone; therefore, a
quantitative acute dietary exposure assessment is unnecessary.
    ii. Chronic exposure. In conducting the chronic dietary exposure
assessment EPA used the food consumption data from the United States
Department of Agriculture (USDA) 1994-1996 and 1998 Nationwide
Continuing Surveys of Food Intakes by Individuals (CSFII). As to
residue levels in food, EPA conducted an unrefined, screening-level
chronic dietary risk assessment assuming tolerance level residues for
grapes, raisins, and all other processed grape commodities; and 100% of
all grapes are treated with pyriofenone.
    iii. Cancer. Based on the data summarized in Unit III.A., EPA has
concluded that pyriofenone does not pose a cancer risk to humans.
Therefore, a dietary exposure assessment for the purpose of assessing
cancer risk is unnecessary.
    iv. Anticipated residue and percent crop treated (PCT) information.
EPA did not use anticipated residue information in the dietary
assessment for pyriofenone. Tolerance level residues and/or 100 PCT
were assumed for all food commodities.
    2. Dietary exposure from drinking water. Pyriofenone is not
registered for use in the United States; therefore, exposure to
pyriofenone in drinking water is not expected.
    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). Pyriofenone is not
registered for any specific use patterns that would result in
residential exposure.
    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 pyriofenone to share a common mechanism of
toxicity with any other substances, and pyriofenone does not appear to
produce a toxic metabolite produced by other substances. For the
purposes of this tolerance assessment action, therefore, EPA has not
assumed that pyriofenone 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 the policy statements
released by EPA's OPP concerning common mechanism determinations and
procedures for cumulating effects from substances found to have a
common mechanism on EPA's Web site 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 Safety
Factor (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 toxicological database
for pyriofenone is complete with regard to pre- and postnatal toxicity,
and there are no residual uncertainties. As the data summarized in Unit
III.A. showed, pyriofenone exposure did not result in quantitative or
qualitative increased sensitivity in the young.
    3. Conclusion. EPA has determined that reliable data show the
safety of infants and children would be adequately protected if the
FQPA SF were reduced to 1x. That decision is based on the following
findings:
    i. The toxicity database for pyriofenone is complete.
    ii. There is no indication that pyriofenone is a neurotoxic
chemical and there is no need for a developmental neurotoxicity study
or additional uncertainty factors (UFs) to account for neurotoxicity.
    iii. There is no evidence that pyriofenone results in increased
susceptibility in in utero rats or rabbits in the prenatal
developmental studies or in young rats in the 2-generation reproduction
study.
    iv. There are no residual uncertainties identified in the exposure
databases. The dietary food exposure assessment was performed based on
the assumptions of 100 PCT and tolerance-level residues. This
assessment will not underestimate the exposure and risks posed by
pyriofenone.

E. Aggregate Risks and Determination of Safety

    EPA determines whether acute and chronic dietary pesticide
exposures are safe by comparing aggregate exposure estimates to the
acute PAD (aPAD) and chronic PAD (cPAD). For linear cancer risks, EPA
calculates the lifetime probability of acquiring cancer given the
estimated aggregate exposure. Short-, intermediate-, and chronic-term
risks are evaluated by comparing the estimated aggregate food, water,
and residential exposure to the appropriate PODs to ensure that an
adequate MOE exists. For this action there is potential exposure to
pyriofenone from food only.
    1. Acute risk. An acute aggregate risk assessment takes into
account acute exposure estimates from dietary consumption of food and
drinking water. No adverse effect resulting from a single oral exposure
was identified and no acute dietary endpoint was selected. Therefore,
pyriofenone is not expected to pose an acute risk.
    2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that chronic exposure to
pyriofenone from food only will utilize 1% of the cPAD for children (1-
2 years old), the population group receiving the greatest exposure.
There are no residential uses for pyriofenone. Based on the explanation
in Unit III.C.3., regarding residential use patterns, chronic
residential exposure to residues of pyriofenone is not expected.
    3. Aggregate cancer risk for U.S. population. Based on the lack of
evidence of carcinogenicity in two adequate rodent carcinogenicity
studies, pyriofenone is classified as ``not likely to be carcinogenic
to humans.'' EPA does not expect pyriofenone to pose a 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 pyriofenone residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    A liquid chromatography/mass spectrometry/mass spectrometry (LC/MS/
MS) method based on the proposed enforcement method (Method ISK 0341/
074208, Revision 4) was used to determine residues of
pyriofenone in or on grapes (Raw Agricultural Commodity (RAC)) and its
processed fractions for the crop field trial and grape processing
studies associated with this petition. The validated limit of
quantitation (LOQ) is 0.01 ppm. This method was adequately validated
for data collection purposes and a successful independent laboratory
validation study was conducted. Therefore, the LC/MS/MS method is
acceptable for use as an enforcement method.
    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>; email address:
<EMAIL_ADDRESS>
B. International Residue Limits

    In making its tolerance decisions, EPA seeks to harmonize U.S.
tolerances with international standards whenever possible, consistent
with U.S. food safety standards and agricultural practices. EPA
considers the international maximum residue limits (MRLs) established
by the Codex Alimentarius Commission (Codex), as required by FFDCA
section 408(b)(4). The Codex Alimentarius is a joint United Nations
Food and Agriculture Organization/World Health Organization food
standards program, and it is recognized as an international food safety
standards-setting organization in trade agreements to which the United
States is a party. EPA may establish a tolerance that is different from
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain
the reasons for departing from the Codex level MRL.
    The Codex has not established a MRL for pyriofenone. However,
review of this tolerance on imported grapes is being conducted with
Canada, and the U.S. and Canada are harmonized on the residue
definition and recommended tolerances.

C. Revisions to Petitioned-For Tolerances

    The tolerance level for grape being established by EPA differs from
that

proposed in the tolerance petition submitted by the ISK Biosciences
Corporation. The Agency used the Organization for Economic Cooperation
and Development tolerance calculation procedures to determine that the
tolerance level of 0.30 ppm is needed. The petitioner did not propose a
separate tolerance for grape, raisin, but processing studies showed
that residues could concentrate, necessitating a higher tolerance of
0.50 ppm. Finally, EPA has revised the tolerance expression to clarify
that:
    1. As provided in FFDCA section 408(a)(3), the tolerance covers
metabolites and degradates of pyriofenone not specifically mentioned.
    2. Compliance with the specified tolerance levels is to be
determined by measuring only the specific compounds mentioned in the
tolerance expression.

V. Conclusion

    Therefore, tolerances are established (without U.S. registrations)
for residues of the fungicide, pyriofenone, including its metabolites
and degradates, in or on grape at 0.30 ppm and grape, raisin at 0.50
ppm.

VI. Statutory and Executive Order Reviews

    This final rule establishes tolerances under FFDCA 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 FFDCA section 408(d), 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 FFDCA section 408(n)(4). 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) (Pub. L. 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: February 17, 2012.
Steven Bradbury,
Director, Office of Pesticide Programs.

    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 180.660 is added to subpart C to read as follows:

Sec.  180.660  Pyriofenone; tolerances for residues.

    (a) General. Tolerances are established for residues of the
fungicide pyriofenone, including its metabolites and degradates, in or
on the following commodities listed in the table. Compliance with the
tolerance levels specified in the table is to be determined by
measuring only pyriofenone, (5-chloro-2-methoxy-4-methyl-3-
pyridinyl)(2,3,4-trimethoxy-6-methylphenyl) methanone, in or on the
following commodities:

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Grape \1\....................................................       0.30
Grape, raisin \1\............................................       0.50
------------------------------------------------------------------------
\1\ There are no U.S. registrations for grape and grape, raisin.

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]

[FR Doc. 2012-5271 Filed 3-6-12; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 86, Number 230 (Friday, December 3, 2021)]
[Rules and Regulations]
[Pages 68564-68566]
[FR Doc No: 2021-26309]

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

DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket Number USCG-2021-0808]
RIN 1625-AA00

Safety Zone; Tchefuncte River, Madisonville, LA

AGENCY: Coast Guard, DHS.

ACTION: Temporary final rule.

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

SUMMARY: The Coast Guard is establishing a temporary safety zone for a
fireworks display on December 4, 2021 from 9 p.m. through 10 p.m. The
safety zone is needed to protect people and the environment on these
navigable waters of the Tchefuncte River, LA. This proposed rulemaking
would prohibit persons and vessels from entering the safety zone unless
authorized by the Captain of the Port (COTP) Sector New Orleans or a
designated representative.

DATES: This rule is effective from 9 p.m. to 10 p.m. on December 4,
2021.

ADDRESSES: To view documents mentioned in this preamble as being
available in the docket, go to https://www.regulations.gov, type USCG-
2021-0808 in the search box and click ``Search.'' Next, in the Document
Type column, select ``Supporting & Related Material.''

FOR FURTHER INFORMATION CONTACT: If you have questions about this
proposed rulemaking, call or email Lieutenant Commander William A.
Stewart, Waterways Management Division Chief, U.S. Coast Guard;
telephone<PHONE_NUMBER>, email [email protected].

SUPPLEMENTARY INFORMATION:

I. Table of Abbreviations

BNM Broadcast Notice to Mariners
CFR Code of Federal Regulations
COTP Captain of the Port
DHS Department of Homeland Security
FR Federal Register
LNM Local Notice to Mariners
NPRM Notice of proposed rulemaking
Sec.  Section
U.S.C. United States Code

II. Background Information and Regulatory History

    On October 19, 2021, the Coast Guard received a marine event permit
application for a fireworks display on December 4, 2021 from 9 p.m.
through 10 p.m. Fireworks display will be launched from a barge in the
Tchefuncte River in the approximate position 30 23-52.4 N, 90 09-14.48
W. In response, on November 10, 2021, the Coast Guard published a
notice of proposed rulemaking (NPRM) titled ``Safety Zone; Tchefuncte
River, Madisonville, LA'' (86 FR 62500). There we stated why we issued
the NPRM, and invited comments on our proposed regulatory action
related to this fireworks display. During the comment period that ended
November 22, 2021, we received no comments.
    Under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause
exists for making this rule effective less than 30 days after
publication in the Federal Register. Delaying the effective date of
this rule would be impracticable because immediate action is needed to
respond to the potential safety hazards associated with this fireworks
display.

III. Legal Authority and Need for Rule

    The Coast Guard is issuing this rule under authority in 46 U.S.C.
70034 (previously 33 U.S.C. 1231). The COTP New Orleans has determined
that potential hazards associated with the fireworks to be used in this
December 4, 2021 display will be a safety concern for anyone within a
200 yard radius of the barge on the Tchefuncte River at 30 23-52.4 N,
90 09-14.48 W. The purpose of this rule is to ensure safety of vessels
and the navigable waters in the safety zone before, during, and after
the scheduled event.

IV. Discussion of Comments, Changes, and the Rule

    As noted above, we received no comments on our NPRM published on
November 10, 2021. There are no changes in the regulatory text of this
rule from the proposed rule in the NPRM.
    This rule establishes a safety zone from 9 p.m. to 10 p.m. on
December 4, 2021. The safety zone will cover all navigable waters
within 200 yards of a barge on the Tchefuncte River located at 30 23-
52.4 N, 90 09-14.48 W. The duration of the zone is intended to ensure
the safety of vessels and these navigable waters before, during, and
after the scheduled 9:30 p.m. to 9:40 p.m. fireworks display. No vessel
or person will be permitted to enter the safety zone without obtaining
permission from the COTP or a designated representative.

V. Regulatory Analyses

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

A. Regulatory Planning and Review

    Executive Orders 12866 and 13563 direct agencies to assess the
costs and benefits of available regulatory alternatives and, if
regulation is necessary, to select regulatory approaches that maximize
net benefits. This rule has not been designated a ``significant
regulatory action,'' under Executive Order 12866. Accordingly, this
rule has not been reviewed by the Office of Management and Budget
(OMB).
    This regulatory action determination is based on establishing a
temporary safety zone within a 200 yard radius of the deck barge
located on the Tchefuncte River at 30 23-52.4 N, 90 09-14.48 W on
December 4, 2021 from 9 p.m. to 10 p.m. Moreover, the rule would allow
vessels to seek permission to enter the zone.

B. Impact on Small Entities

    The Regulatory Flexibility Act of 1980, 5 U.S.C. 601-612, as
amended, requires Federal agencies to consider the potential impact of
regulations on small entities during rulemaking. The term ``small
entities'' comprises small businesses, not-for-profit organizations
that are independently owned and operated and are not dominant in their
fields, and governmental jurisdictions with populations of less than
50,000. The Coast Guard received no comments from the Small Business
Administration on this rulemaking. The Coast Guard certifies under 5
U.S.C. 605(b) that this rule will not have a significant economic
impact on a substantial number of small entities.
    While some owners or operators of vessels intending to transit the
safety zone may be small entities, for the reasons stated in section
V.A above, this rule will not have a significant economic impact on any
vessel owner or operator.
    Under section 213(a) of the Small Business Regulatory Enforcement
Fairness Act of 1996 (Pub. L. 104-121), we want to assist small
entities in understanding this rule. If the rule would affect your
small business, organization, or governmental jurisdiction and you have
questions concerning its provisions or options for compliance, please
call or email the person listed in the FOR FURTHER INFORMATION CONTACT
section.
    Small businesses may send comments on the actions of Federal
employees who enforce, or otherwise determine compliance with, Federal
regulations to the Small Business and Agriculture Regulatory
Enforcement Ombudsman and the Regional Small Business Regulatory
Fairness Boards. The Ombudsman evaluates these actions annually and
rates each agency's responsiveness to small business. If you wish to
comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR
(1-888-734-3247). The Coast Guard will not retaliate against small
entities that question or complain about this rule or any policy or
action of the Coast Guard.

C. Collection of Information

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

D. Federalism and Indian Tribal Governments

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

E. Unfunded Mandates Reform Act

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

F. Environment

    We have analyzed this rule under Department of Homeland Security
Directive 023-01, Rev. 1, associated implementing instructions, and
Environmental Planning COMDTINST 5090.1 (series), which guide the Coast
Guard in complying with the National Environmental Policy Act of 1969
(42 U.S.C. 4321-4370f), and have determined that this action is one of
a category of actions that do not individually or cumulatively have a
significant effect on the human environment. This rule involves a
safety zone lasting one hour that would prohibit entry within a 200
yard radius around the deck barge located on the Tchefuncte River at 30
23-52.4 N, 90 09-14.48 W. It is categorically excluded from further
review under paragraph L60 (a) of Appendix A, Table 1 of DHS
Instruction Manual 023-01-001-01, Rev. 1. A Record of Environmental
Consideration supporting this determination is available in the docket.
For instructions on locating the docket, see the ADDRESSES section of
this preamble.

G. Protest Activities

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

List of Subjects in 33 CFR Part 165

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

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

PART 165--REGULATED NAVIGATION AREAS AND LIMITED ACCESS AREAS

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

    Authority:  46 U.S.C. 70034, 70051; 33 CFR 1.05-1, 6.04-1, 6.04-
6, and 160.5; Department of Homeland Security Delegation No. 0170.1,
Revision No. 01.2.

0
2. Add Sec.  165.T08-0808 to read as follows:

Sec.  165.T08-0808   Safety Zone; Tchefuncte River, Madisonville, LA.

    (a) Location. The following area is a safety zone: All navigable
waters within a 200 yard radius of the deck barge at position 30 23-
52.4 N, 90 09-14.48 W on the Tchefuncte River, Madisonville, LA.
    (b) Definitions. As used in this section, designated representative
means a Coast Guard Patrol Commander, including a Coast Guard coxswain,
petty officer, or other officer operating a Coast Guard vessel and a
Federal, State, and local officer designated by or assisting the
Captain of the Port Sector New Orleans (COTP) in the enforcement of the
safety zone.
    (c) Regulations. (1) Under the general safety zone regulations in
subpart C of this part, persons and vessels may not enter the safety
zone described in paragraph (a) of this section unless authorized by
the COTP or the COTP's designated representative.
    (2) To seek permission to enter, contact the COTP or the COTP's
representative by VHF-FM radio channels 16 or 67. Those in the safety
zone must comply with all lawful orders or directions given to them by
the COTP or the COTP's designated representative.
    (d) Enforcement period. This section will be enforced from 9 p.m.
through 10 p.m. on December 4, 2021.
    (e) Information broadcasts. The COTP or a designated representative
will inform the public of the enforcement times and date for this
safety zone through Broadcast Notices to Mariners (BNMs), Local Notices
to Mariners (LNMs), and/or Marine Safety Information Broadcasts (MSIBs)
as appropriate.

    Dated: November 29, 2021
W.E. Watson,
Captain, U.S. Coast Guard, Captain of the Port Sector New Orleans.
[FR Doc. 2021-26309 Filed 12-2-21; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register: November 9, 2006 (Volume 71, Number 217)]
[Notices]
[Page 65795]
[DOCID:fr09no06-71]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. RP07-45-000]

Northern Natural Gas Company; Notice of Proposed Chages in FERC
Gas Tariff

November 2, 2006.
    Take notice that on October 31, 2006, Northern Natural Gas Company
(Northern) tendered for filing to become part of its FERC Gas Tariff,
Fifth Revised Volume No. 1, Sixth Revised Sheet No. 54A, to be
effective on December 1, 2006.
    Northern further states that copies of the filing have been mailed
to each of its customers and interested state commissions.
    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 and 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. Such notices,
motions, or protests must be filed in accordance with the provisions of
Section 154.210 of the Commission's regulations (18 CFR 154.210).
Anyone filing an intervention or protest must serve a copy of that
document on the Applicant. Anyone filing an intervention or protest on
or before the intervention or protest date need not serve motions to
intervene or protests on persons other than the Applicant.
    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 14 copies of the protest or intervention to the Federal
Energy Regulatory Commission, 888 First Street, NE., Washington, DC
20426.
    This filing is accessible online 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 e-mail
notification when a document is added to a subscribed docket(s). For
assistance with any FERC Online service, please e-mail
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For

TTY, call<PHONE_NUMBER>.

Magalie R. Salas,
Secretary.
 [FR Doc. E6-18937 Filed 11-8-06; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register: October 4, 2005 (Volume 70, Number 191)]
[Notices]
[Page 57887]
[DOCID:fr04oc05-83]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[FEMA-1607-DR]

Louisiana; Amendment No. 2 to Notice of a Major Disaster
Declaration

AGENCY: Federal Emergency Management Agency, Emergency Preparedness and
Response Directorate, Department of Homeland Security.

ACTION: Notice.

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

SUMMARY: This notice amends the notice of a major disaster declaration
for the State of Louisiana (FEMA-1607-DR), dated September 24, 2005,
and related determinations.

EFFECTIVE DATE: September 27, 2005.

FOR FURTHER INFORMATION CONTACT: Magda Ruiz, Recovery Division, Federal
Emergency Management Agency, Washington, DC 20472,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: The notice of a major disaster declaration
for the State of Louisiana is hereby amended to include the following
areas among those areas determined to have been adversely affected by
the catastrophe declared a major disaster by the President in his
declaration of September 24, 2005:

The parishes of Allen, Lafourche, and Terrebonne for Individual
Assistance (already designated for debris removal and emergency
protective measures [Categories A and B] under the Public Assistance
program, including direct Federal assistance.)

(The following Catalog of Federal Domestic Assistance Numbers (CFDA)
are to be used for reporting and drawing funds: 97.030, Community
Disaster Loans; 97.031, Cora Brown Fund Program; 97.032, Crisis
Counseling; 97.033, Disaster Legal Services Program; 97.034,
Disaster Unemployment Assistance (DUA); 97.046, Fire Management
Assistance; 97.048, Individuals and Households Housing; 97.049,
Individuals and Households Disaster Housing Operations; 97.050
Individuals and Households Program-Other Needs, 97.036, Public
Assistance Grants; 97.039, Hazard Mitigation Grant Program.)

R. David Paulison,
Acting Under Secretary, Emergency Preparedness and Response, Department
of Homeland Security.
[FR Doc. 05-19811 Filed 10-3-05; 8:45 am]

BILLING CODE 9110-10-P


Ron Evans/RTP/USEPA/US

03/13/2008 10:27 AM

To

"King, Heidi R."<EMAIL_ADDRESS> cc

Lydia Wegman, Janet Cakir/RTP/USEPA/US@EPA, Tricia Crabtree/RTP/USEPA/US@EPA

Subject

meeting this afternoon scheduled

Heidi, per your voicemail, I have set aside 2 til 4 today to go over your final comments on the RIA.  I hope we don't need the full 2 hours, I presumed that we can also cover the final steps, ROCIS etc during that meeting as well.   Based on your voicemail it sounds hopeful that everything will be completed by 5:00pm.  Talk to you later.

Ron

P.S.  You indicated last evening that you may have comments already on the 2030 appendix.  If you have those in writing, either electronic or hand written, it would be helpful to get those earlier than 2:00 so we can get a headstart on addressing them.  Thanks.