[Federal Register Volume 81, Number 79 (Monday, April 25, 2016)]
[Notices]
[Pages 24119-24120]
[FR Doc No: 2016-09557]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Docket ID FEMA-2007-0008]

National Advisory Council; Meeting

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Committee Management; Notice of Federal Advisory Committee
meeting.

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SUMMARY: The Federal Emergency Management Agency (FEMA) National
Advisory Council (NAC) will meet in person on May 10, 11, and 12, 2016
in San Antonio, TX. The meeting will be open to the public.

DATES: The NAC will meet on Tuesday, May 10, 2016, from 9:00 a.m. to
2:30 p.m., on Wednesday, May 11, 2016 from 8:30 a.m. to 5:30 p.m., and
on Thursday, May 12 from 8:30 a.m. to 10:20 a.m. Central Daylight Time
(CDT). Please note that the meeting may close early if the NAC has
completed its business.

ADDRESSES: The meeting will be held at The Menger Hotel located at 204
Alamo Plaza in San, Antonio, TX 78205. It is recommended that attendees
register with FEMA prior to the meeting by providing your name,
telephone number, email address, title, and organization to the person
listed in FOR FURTHER INFORMATION CONTACT below.
    For information on facilities or services for individuals with
disabilities or to request special assistance at the meeting, contact
the person listed in FOR FURTHER INFORMATION CONTACT below as soon as
possible.
    To facilitate public participation, members of the public are
invited to provide written comments on the issues to be considered by
the NAC. The ``Agenda'' section below outlines these

issues. Written comments must be submitted and received by 5:00 p.m.
CDT on May 9, 2016, identified by Docket ID FEMA-2007-0008, and
submitted by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments.
     Email<EMAIL_ADDRESS>Include the docket number
in the subject line of the message.
     Fax:<PHONE_NUMBER>.
     Mail: Regulatory Affairs Division, Office of Chief
Counsel, FEMA, 500 C Street SW., Room 8NE, Washington, DC 20472-3100.
    Instructions: All submissions received must include the words
``Federal Emergency Management Agency'' and the docket number for this
action. Comments received will be posted without alteration at http://www.regulations.gov, including any personal information provided.
    Docket: For access to the docket to read comments received by the
NAC, go to http://www.regulations.gov, and search for the Docket ID
listed above.
    A public comment period will be held on Wednesday, May 11 from 2:50
p.m. to 3:10 p.m. CDT. All speakers must limit their comments to 3
minutes. Comments should be addressed to the committee. Any comments
not related to the agenda topics will not be considered by the NAC. To
register to make remarks during the public comment period, contact the
individual listed below by May 9, 2016. Please note that the public
comment period may end before the time indicated, following the last
call for comments.

FOR FURTHER INFORMATION CONTACT: Alexandra Woodruff, Designated Federal
Officer, Office of the National Advisory Council, Federal Emergency
Management Agency, 500 C Street SW., Washington, DC 20472-3184,
telephone<PHONE_NUMBER>, fax<PHONE_NUMBER>, and email<EMAIL_ADDRESS>The NAC Web site is: http://www.fema.gov/national-advisory-council.

SUPPLEMENTARY INFORMATION: Notice of this meeting is given under the
Federal Advisory Committee Act, 5 U.S.C. Appendix.
    The NAC advises the FEMA Administrator on all aspects of emergency
management. The NAC incorporates state, local, and tribal government,
and private sector input in the development and revision of FEMA plans
and strategies. The NAC includes a cross-section of senior officials,
emergency managers, and emergency response providers from state, local,
and tribal governments, the private sector, and nongovernmental
organizations.
    Agenda: On Tuesday, May 10, the NAC will review FEMA's response
from the NAC's February 2016 recommendations, receive briefings from
FEMA Executive Staff (Office of Response and Recovery, National
Preparedness Directorate, and Federal Insurance and Mitigation
Administration), and a briefing on military support to FEMA.
    On Wednesday, May 11, the NAC will hear from a FEMA Regional
Administrator about activities in the FEMA Regions and engage in an
open discussion with the FEMA Administrator. The three NAC
subcommittees (Federal Insurance and Mitigation Subcommittee,
Preparedness and Protection Subcommittee, and Response and Recovery
Subcommittee) and the Spontaneous Volunteers Ad Hoc Subcommittee will
provide reports to the NAC about their work, whereupon the NAC will
deliberate on any recommendations presented in the subcommittees'
reports, and, if appropriate, vote on recommendations for the FEMA
Administrator. The subcommittee reports will be posted on the NAC Web
page by 8:30 a.m. on Wednesday, May 11. The NAC will receive a briefing
about Supply Chain Resiliency and engage in a facilitated discussion of
the status of previously submitted NAC recommendations.
    On Thursday, May 12, the NAC will review agreed upon
recommendations and confirm charges for the subcommittees as well as
engage in an open discussion with the FEMA Deputy Administrator.
    The full agenda and any related documents for this meeting will be
posted by Friday, May 6 on the NAC Web site at http://www.fema.gov/national-advisory-council.

    Dated: April 20, 2016.
W. Craig Fugate,
Administrator, Federal Emergency Management Agency.
[FR Doc. 2016-09557 Filed 4-22-16; 8:45 am]
 BILLING CODE 9111-48-P


[Federal Register Volume 77, Number 135 (Friday, July 13, 2012)]
[Notices]
[Pages 41412-41413]
[FR Doc No: 2012-17091]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-P-0081]

Determination That CHLOROMYCETIN (Chloramphenicol) Capsules, 250
Milligrams, Were Withdrawn From Sale for Reasons of Safety or
Effectiveness

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) has determined that
CHLOROMYCETIN (chloramphenicol) Capsules, 250 milligrams (mg), were
withdrawn from sale for reasons of safety or effectiveness. The Agency
will not accept or approve abbreviated new drug applications (ANDAs)
for chloramphenicol capsules, 250 mg.

FOR FURTHER INFORMATION CONTACT: Nikki Mueller, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6312, Silver Spring, MD 20993-0002, 301-
796-3601.

SUPPLEMENTARY INFORMATION: In 1984, Congress enacted the Drug Price
Competition and Patent Term Restoration Act of 1984 (Pub. L. 98-417)
(the 1984 amendments), which authorized the approval of duplicate
versions of drug products under an ANDA procedure. ANDA applicants
must, with certain exceptions, show that the drug for which they are
seeking approval contains the same active ingredient in the same
strength and dosage form as the ``listed drug,'' which is a version of
the drug that was previously approved. ANDA applicants do not have to
repeat the extensive clinical testing otherwise necessary to gain
approval of a new drug application (NDA). The only clinical data
required in an ANDA are data to show that the drug that is the subject
of the ANDA is bioequivalent to the listed drug.
    The 1984 amendments include what is now section 505(j)(7) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)(7)), which
requires FDA to publish a list of all approved drugs. FDA publishes
this list as part of the ``Approved Drug Products With Therapeutic
Equivalence Evaluations,'' which is known generally as the ``Orange
Book.'' Under FDA regulations, drugs are removed from the list if the
Agency withdraws or suspends approval of the drug's NDA or ANDA for
reasons of safety or effectiveness or if FDA determines that the listed
drug was withdrawn from sale for reasons of safety or effectiveness (21
CFR 314.162).
    A person may petition the Agency to determine, or the Agency may
determine on its own initiative, whether a listed drug was withdrawn
from sale for reasons of safety or effectiveness. This determination
may be made at any time after the drug has been withdrawn from sale,
but must be made prior to approving an ANDA that refers to the listed
drug (Sec.  314.161 (21 CFR 314.161)). FDA may not approve an ANDA that
does not refer to a listed drug.
    CHLOROMYCETIN (chloramphenicol) Capsules, 250 mg, are the subject
of ANDA 60-591, held by Parkedale Pharmaceuticals, and initially
approved on December 8, 1950. CHLOROMYCETIN is an antibiotic indicated
to treat only serious infections for which less potentially dangerous
drugs are ineffective or contraindicated.
    In a letter dated October 9, 2007, Parkedale Pharmaceuticals
requested withdrawal of ANDA 60-591 for CHLOROMYCETIN (chloramphenicol)
Capsules, 50 mg, 100 mg and 250 mg. In the Federal Register of February
11, 2009 (74 FR 6896), FDA announced that it was withdrawing approval
of ANDA 60-591, effective March 13, 2009, and moved the drug to the
``Discontinued Drug Product List'' section of the Orange Book.
    Armenpharm, Ltd., submitted a citizen petition dated February 7,
2011 (Docket No. FDA-2011-P-0081), under 21 CFR 10.30, requesting that
the Agency determine whether CHLOROMYCETIN (chloramphenicol) Capsules,
250 mg, were withdrawn from sale for reasons of safety or
effectiveness.
    After considering the citizen petition, and based on the
information we have at this time, FDA has determined under Sec.
314.161 that CHLOROMYCETIN (chloramphenicol) Capsules, 250 mg, were
withdrawn for reasons of safety or effectiveness. We have carefully
reviewed Agency records concerning the withdrawal of CHLOROMYCETIN
(chloramphenicol) Capsules, 250 mg, from sale. We have also
independently evaluated relevant literature and data for possible
postmarketing adverse events. At the time of the approval of
CHLOROMYCETIN (chloramphenicol) Capsules, 250 mg, there was significant
unmet medical need. With the approval of additional therapies with less
severe adverse drug effects, FDA has determined that the risks
associated with CHLOROMYCETIN (chloramphenicol) Capsules, 250 mg, as
currently labeled, outweigh the benefits. Most importantly,
CHLOROMYCETIN

(chloramphenicol) Capsules, 250 mg, may cause a number of adverse
reactions, the most serious being bone marrow depression (anemia,
thrombocytopenia, and granulocytopenia temporally associated with
treatment). A boxed warning in the prescribing information for both
chloramphenicol sodium succinate injection and chloramphenicol capsules
states that serious hypoplastic anemia, thrombocytopenia, and
granulocytopenia are known to occur after administration of
chloramphenicol. The drug product labeling recommends extensive safety
monitoring, including baseline blood studies followed by periodic blood
studies approximately every 2 days during therapy. The boxed warning
also describes fatal aplastic anemia associated with administration of
the drug and aplastic anemia attributed to chloramphenicol that later
terminated in leukemia. There is published literature which suggests
that the risk of fatal aplastic anemia associated with the oral
formulation of chloramphenicol may be higher than the risk associated
with the intravenous formation.
    FDA has also reviewed the latest approved labeling for the product
and has determined that this labeling is inadequate and a Risk
Evaluation and Mitigation Strategy (REMS) would be required to ensure
that the benefits of the drug outweigh its risks. The REMS may include
Elements to Assure Safe Use, including restricted distribution, and a
Medication Guide could be required as part of the labeling. FDA has
determined that additional nonclinical and possibly clinical studies of
safety and efficacy would be necessary before CHLOROMYCETIN
(chloramphenicol) Capsules, 250 mg, could be considered for
reintroduction to the market.
    Accordingly, the Agency will remove CHLOROMYCETIN (chloramphenicol)
Capsules, 250 mg, from the list of drug products published in the
Orange Book. FDA will not accept or approve ANDAs that refer to this
drug product.

    Dated: July 10, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-17091 Filed 7-12-12; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register Volume 87, Number 132 (Tuesday, July 12, 2022)]
[Notices]
[Pages 41308-41309]
[FR Doc No: 2022-14801]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. ID-8209-001]

Ancell, Dale; Notice of Filing

    Take notice that on July 6, 2022, Dale Ancell submitted for filing,
application for authority to hold interlocking positions, pursuant to
section 305(b) of the Federal Power Act, 16 U.S.C. 825d (b) and Part
45.1 and 45.8 of the Federal Energy Regulatory Commission's
(Commission) Rules of Practice and Procedure, 18 CFR 45.8.
    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. Such notices,
motions, or protests must be filed on or before the comment date. On or
before the comment date, it is not necessary to serve motions to
intervene or protests on persons other than the Applicant.
    In addition to publishing the full text of this document in the
Federal Register, the Commission provides all interested persons an
opportunity to view and/or print the contents of this document via the
internet through the Commission's Home Page (http://www.ferc.gov) using
the ``eLibrary'' link. Enter the docket number excluding the last three
digits in the docket number field to access the document. At this time,
the Commission has suspended access to the Commission's Public
Reference Room, due to the proclamation declaring a National Emergency
concerning the Novel Coronavirus Disease (COVID-19), issued by the
President on March 13, 2020. For assistance, contact the Federal Energy
Regulatory Commission at [email protected] or call toll-free,
(886) 208-3676 or TYY,<PHONE_NUMBER>.
    The Commission strongly encourages electronic filings of comments,
protests and interventions in lieu of paper using the ``eFiling'' link
at http://www.ferc.gov. Persons unable to file electronically may mail
similar pleadings to the Federal Energy Regulatory Commission, 888
First Street NE, Washington, DC 20426. Hand delivered submissions in
docketed proceedings should be delivered to

Health and Human Services, 12225 Wilkins Avenue, Rockville, Maryland
20852.
    Comment Date: 5:00 p.m. Eastern Time on July 27, 2022.

    Dated: July 6, 2022.
Kimberly D. Bose,
Secretary.
[FR Doc. 2022-14801 Filed 7-11-22; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register: September 30, 2010 (Volume 75, Number 189)]
[Rules and Regulations]
[Page 60327-60333]
[DOCID:fr30se10-11]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2007-0677; FRL-8845-7]

Fluoxastrobin; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of
fluoxastrobin in or on multiple commodities which are identified and
discussed later in this document. Arysta LifeScience North America, LLC
requested these tolerances under the Federal Food, Drug, and Cosmetic
Act (FFDCA).

DATES: This regulation is effective September 30, 2010. Objections and
requests for hearings must be received on or before November 29, 2010,
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-2007-0677. 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<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: John Bazuin, Registration Division
(7504P), 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 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://www.gpoaccess.gov/ecfr.

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-2007-0677 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
November 29, 2010. 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-2007-0677, 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 Tolerances

    In the Federal Register of October 7, 2009 (74 FR 51597) (FRL-8792-
7), 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
9F7567) by Arysta LifeScience North America, LLC, 15401 Weston Parkway,
Suite 150, Cary, NC 27513. The petition requested that 40 CFR 180.609
be amended by establishing tolerances for residues of the fungicide
fluoxastrobin, (1E)-[2-[[6-(2-chlorophenoxy)-5-fluoro-4-
pyrimidinyl]oxy]phenyl](5,6-dihydro-1,4,2-dioxazin-3-yl)methanone O-
methyloxime and its Z isomer, (1Z)-[2-[[6-(2-chlorophenoxy)-5-fluoro-4-
pyrimidinyl]oxy]phenyl](5,6-dihydro-1,4,2-dioxazin-3-yl)methanone O-
methyloxime in or on aspirated grain fractions at 15 parts per million
(ppm); meat byproducts (cattle, goat, horse, sheep) at 0.2 ppm; sweet
corn, forage at 13 ppm; sweet corn (kernels plus cob with husks
removed) at 0.02 ppm; sweet corn, stover at 10 ppm; wheat, bran at 0.2
ppm; wheat, forage at 7.0 ppm; wheat, grain at 0.09 ppm; wheat, hay at
17 ppm; and wheat, straw at 11 ppm. The proposed tolerance in or on
aspirated grain fractions is actually a decrease in the pre-existing
tolerance for fluoxastrobin and its Z isomer in 40 CFR 180.609 of 20
ppm. The proposed meat byproduct tolerances are actually changes in the
tolerance expression from fluoxastrobin, its Z isomer, and its phenoxy-
hydroxypyrimidine metabolite, 6-(2-chlorophenoxy)-5-fluoro-4-
pyrimidinol to fluoxastrobin and its Z isomer and an increase in the
pre-existing tolerance levels in 40 CFR 180.609 of 0.10 ppm for meat
byproducts of cattle, goat, horse, and sheep. That notice referenced a
summary of the petition prepared by Arysta LifeScience North America,
LLC, 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 made
the following changes to the proposed fluoxastrobin tolerances. Minor
changes have been made to several commodity names to conform them to
the Agency's Food and Feed Commodity Vocabulary. The tolerance
expression for the meat byproduct commodities has been corrected to add
the phenoxy-hydroxypyrimidine metabolite. The proposed tolerance of
0.02 ppm in or on sweet corn, kernels plus cob with husks removed and
of 0.2 ppm in or on wheat, bran have been reduced and the proposed
tolerance of 15 ppm in or on aspirated grain fractions has been
increased. 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 fluoxastrobin including
exposure resulting from the tolerances established by this action.
EPA's assessment of exposures and risks associated with fluoxastrobin
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.
    Fluoxastrobin has a low order of acute toxicity via the oral,
dermal and inhalation routes of exposure. Fluoxastrobin is a moderate
eye irritant but is neither a dermal irritant nor a skin sensitizer.
    Fluoxastrobin appears to have mild or low toxicity following
repeated administration in all tested species other than the dog. In
both the 90-day and 1-year oral feeding dog studies, there was liver
toxicity in the form of cholestasis as evidenced by hepatocytomegaly
and cytoplasmic granular changes associated with increased liver weight
and increased serum liver alkaline phospatase (ALP). In addition,
several phase I and phase II liver drug metabolizing enzymes were
induced. Other toxicity in dogs included body weight loss or reduced
gain, decreased food efficiency, and effects on kidneys including
increased relative weight in females and degeneration of proximal
tubular epithelium in males. The no observed adverse effect level
(NOAEL) of 1.5 milligrams/kilograms/day (mg/kg/day) in the 1-year dog
study was used for setting the chronic reference dose (RfD).
    The liver appeared to be a target organ in other studies, as well,
but the toxicological relevance of liver findings in species other than
the dog is questionable. For example, among the changes noted in the
treated animals were increased liver weight in the mouse and rat, and
hypertrophy and cytoplasmic changes in the mouse, but there were no
increases in any of the serum liver enzymes including ALP.
    In the 90-day oral toxicity study in rats, the urinary system in
males was a target organ as evidenced by increased kidney weight and
histopathology findings in kidneys, urinary bladder, and urethra
including the presence of calculi in the urethra and kidneys. In
another rat study, there were markedly increased urinary pHs in males
in addition to increased urinary calcium excretion in the form of
calcium oxalate crystals. Kidney changes were also seen in a 90-day
mouse feeding study with increased kidney weights and tubular
hypertrophy in females. Following 90-day administration in dogs, there
was degeneration of the proximal tubular epithelium in males.
    The adrenal glands seem to be another target organ in males of the
90-day rat study where vacuolation was seen in the zona fasciculata of
the adrenal cortex. In another 30-day rat feeding study, adrenal
cortical cytomegaly with fine vacuolization was seen in all high dose
males and the responses were comparable between the groups treated with
the pure fluoxastrobin E- or 2:1 E/Z-isomers. The adrenal changes are
not likely to be endocrine related effects.
    In the rat and rabbit developmental toxicity studies and the 2-
generation reproduction rat study, there was no increased
susceptibility to prenatal or postnatal exposure to fluoxastrobin and
no effects on reproduction.
    Fluoxastrobin is not acutely neurotoxic in rats up to a single high
dose of 2,000 mg/kg/day or by repeated dietary feeding in the rat
subchronic neurotoxicity screening study where the top dose was nearly
half the limit dose of 1,000 mg/kg/day. Other studies in rats including
the subchronic, chronic toxicity/carcinogenicity, 2-generation
reproduction, and developmental toxicity were tested to or above the
limit dose with no indication of clinical signs, histopathology or
other signs of toxicity that could be attributed to neurotoxicity.
Also, in both the 90-day and 1-year dog studies, neurologic
examinations, including mental status/behavior, gait characteristics,
postural status and reactions, and spinal/cranial reflexes, were
carried out and were found to be within normal limits.
    Fluoxastrobin is not immunotoxic based on repeated dosing studies
in rats and mice. In the 90-day oral toxicity rat study, there was no
difference between the control and treated animals in spleen cell
count, macrophage activities after PMA stimulation and plaque-forming
cell assay after challenge with sheep erythrocytes. Slight decreases
were noted in IgG concentration in the high dose males but not females.
An unacceptable subchronic immunotoxicity study in mice found no
apparent decrease on B-cell activated, T-cell mediated IgM response to
sheep red blood cell (SRBC) at doses as high as 2,383 mg/kg/day.
    Fluoxastrobin and major metabolites were negative in a battery of
genotoxicity tests.
    The carcinogenic potential of fluoxastrobin was adequately tested
in rats and mice of both sexes. The results demonstrated a lack of
treatment-related increase in tumor incidence in rats or mice. There
was no mutagenicity concern and no structure activity relationship
alert. It was concluded that there was no incidence of carcinogenicity
for fluoxastrobin.
    Specific information on the studies received and the nature of the
adverse effects caused by fluoxastrobin as well as the NOAEL and the
lowest-observed-adverse-effect-level (LOAEL) from the toxicity studies
are discussed in the final rule published in the Federal Register of
September 16, 2005 (70 FR 54640) (FRL-7719-9).

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 fluoxastrobin used for
human risk assessment can be found in ``Fluoxastrobin. Human Health
Risk Assessment for Proposed Uses on Sweet Corn, Field Corn/Sweet Corn
Grown for Seed, and Wheat; Revised Tolerances on Peanut and Refined
Peanut Oil Based on a Peanut Processing Study; and Label Revision
Allowing Homeowner Residential Application to Turf Grasses,'' p. 23 in
docket ID number EPA-HQ-OPP-2007-0677.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to fluoxastrobin, EPA considered exposure under the
petitioned-for tolerances as well as all existing fluoxastrobin
tolerances in 40 CFR 180.609. EPA assessed dietary exposures from
fluoxastrobin 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
fluoxastrobin; 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 Continuing Surveys
of Food Intake by Individuals (CSFII). As to residue levels in food,
EPA performed an unrefined (food and drinking water) exposure
assessment. The assumptions of this dietary assessment included
tolerance level residues and 100% crop treated. Based on processing
studies, the processing factors for tomato puree, potato chips, dry
potato (granules/flakes), and potato flour were reduced to 1. Separate
tolerances were set for peanut oil, wheat bran and tomato paste;
therefore, the processing factors for these commodities were set at 1.
For all other processed commodities, Dietary Exposure Evaluation Model
version 7.81 default processing factors were assumed.
    iii. Cancer. Based on the data summarized in Unit III.A., EPA has
concluded that fluoxastrobin 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 and/or PCT information in the
dietary assessment for floxastrobin. Tolerance level residues and 100
PCT were assumed for all food commodities.
    2. Dietary exposure from drinking water. The Agency used screening
level water exposure models in the dietary exposure analysis and risk
assessment for fluoxastrobin in drinking water. These simulation models
take into account data on the physical, chemical, and fate/transport
characteristics of fluoxastrobin. 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 fluoxastrobin for chronic
exposures for non-cancer assessments are estimated to be 33 parts per
billion (ppb) for surface water and less than 1 ppb for ground water.
The modeled estimates of drinking water concentrations were directly
entered into the dietary exposure model. 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).
    Fluoxastrobin has previously been registered for the following uses
that could result in post-application residential exposures: Turf,
including lawns and golf courses. However, applications to residential
turf have previously been restricted to certified pest control
operators. Under consideration in the current risk assessment is a
proposed label that would allow homeowner residential application to
turf, which would result in residential handler exposure. Residential
handlers may be exposed via loading and applying granular fluoxastrobin
for spot treatments and/or broadcast control of turf diseases.
    EPA assessed residential application exposure using the following
assumptions: Because of the potential for application four times per
year, exposure duration is expected to be short-term and intermediate-
term. A short-term dermal endpoint was not identified so only
intermediate-term dermal risks were assessed. Short- and intermediate-
term inhalation risks were also assessed. Homeowner residential
applicators are expected to be adults.
    There is also the potential for homeowners and their families (of
varying ages) to be exposed as a result of entering areas that have
previously been treated with fluoxastrobin. Exposure might occur on
areas such as lawns used by children or recreational areas such as golf
courses used by adults and youths. Potential routes of exposure include
dermal (adults and children) and incidental oral ingestion (children).
Since no acute hazard has been identified, an assessment of episodic
granular ingestion was not conducted. While it is assumed that most
residential use will result in short-term (1 to 30 days)
postapplication exposures, it is believed that intermediate-term
exposures (greater than 30 days up to 180 days) are also possible. The
best data and methodology currently available were used in the
fluoxastrobin residential assessment. Since chemical-specific data were
not available, the Agency used the current approaches for residential
assessment, many of which include recent upgrades to the standard
operating procedures (SOPs). For example, for the hand-to-mouth
calculations for children (three to less than six years old), a 5%
transferability factor was applied to calculate residue levels
appropriate for this exposure pathway. Overall, the Agency believes
that the calculated risks represent screening level estimates.
Estimates are thought to be conservative, even when measures of central
tendency (e.g., most transfer coefficients) are used, because values
that would be considered to be in the lower percentile aspect of any
input parameter have not been used in the calculations. In addition,
maximum application rates have been used for all scenarios. The risk
estimates also assume no dissipation of residues after day zero and do
not take into account the periodic growth and cutting of the grass.
Actual residues should be considerably lower, which is why
intermediate-term exposures are unlikely. Further, because a short-term
dermal toxicity endpoint was not identified, the intermediate-term

endpoint was used for all dermal risk estimates, even though the
residential exposure duration is believed to be mostly short-term based
on the use pattern. Finally, based on the Agency's current practices, a
quantitative post-application inhalation exposure assessment was not
performed at this time, primarily because fluoxastrobin has a very low
vapor pressure. Further information regarding EPA standard assumptions
and generic inputs for residential exposures may be found at http://
www.epa.gov/pesticides/trac/science/trac6a05.pdf.
    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 fluoxastrobin to share a common mechanism of
toxicity with any other substances, and fluoxastrobin does not appear
to produce a toxic metabolite produced by other substances. For the
purposes of this tolerance action, therefore, EPA has assumed that
fluoxastrobin 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 Food Quality
Protection Act (FQPA) Safety Factor (SF). In applying this provision,
EPA either retains the default value of 10X, or uses a different
additional SF when reliable data available to EPA support the choice of
a different factor.
    2. Prenatal and postnatal sensitivity. The toxicity database for
fluoxastrobin, including acceptable developmental toxicity studies in
rats and rabbits, as well as a 2-generation reproductive toxicity
study, provides no indication of prenatal and/or postnasal sensitivity.
    3. Conclusion. EPA has determined that reliable data show the
safety of infants and children is adequately protected if the FQPA SF
is reduced to 1X. That decision is based on the following findings:
    i. The toxicity database for fluoxastrobin is complete except for a
functional immunotoxicity study as required by the recent changes to
the pesticide data requirements. The Agency does have an immunotoxicity
study for fluoxastrobin but it has deficiencies that make it
unacceptable at this time. Nonetheless, the Agency does not believe
that conducting a new immunotoxicity study will result in a lower NOAEL
than the regulatory dose for risk assessment because available data
showed no apparent decrease in B-cell activated, T-cell mediated
immunoglobulin M (IgM) response to sheep red blood cells (SRBC) at
doses as high as 2,383 mg/kg/day. The Agency therefore believes that no
additional safety factor is needed to account for the lack of this
study, but the registrant will be required to upgrade it.
    ii. There is no indication that fluoxastrobin is a neurotoxic
chemical and there is no need for a developmental neurotoxicity study
or additional UFs to account for neurotoxicity.
    iii. There is no evidence that fluoxastrobin 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 chronic dietary food exposure assessments utilized
tolerance-level residues and 100 PCT information for all commodities.
Use of these screening-level assessment values helps ensure that
chronic exposures and risks will not be underestimated. EPA
additionally made conservative (protective) assumptions in the ground
and surface water modeling used to assess exposure to fluoxastrobin in
drinking water. EPA used similarly conservative assumptions to assess
residential post-application exposure of children as well as incidental
oral exposure of toddlers to fluoxastrobin. These assessments will not
underestimate the exposure and risks posed by fluoxastrobin.

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.
    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,
fluoxastrobin 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
fluoxastrobin from food and water will utilize 42% of the cPAD for
children (1-2 years old), the population subgroup receiving the
greatest exposure. Based on the explanation in Unit III.C.3., regarding
residential use patterns, chronic residential exposure to residues of
fluoxastrobin is not expected.
    3. Short- and intermediate-term risk. Fluoxastrobin is currently
registered for uses that could result in both short- and intermediate-
term residential exposure and the Agency has determined that it is
appropriate to aggregate chronic exposure through food and water with
short- and intermediate-term residential exposures of adults and
children to fluoxastrobin. Short- and intermediate-term aggregate
exposure assessments take into account short-and intermediate-term
residential exposure, respectively, plus chronic exposure to food and
water (considered a background exposure level). Because all short- and
intermediate-term quantitative hazard assessments (via the dermal and
incidental oral routes) for fluoxastrobin are based on the same
endpoint, a screening-level, conservative aggregate risk assessment was
conducted that combined the short-term incidental oral and
intermediate-term exposure estimates (i.e., the highest exposure
estimates) in the risk assessments for adults. The Agency believes that
most residential exposure will be short-term, based on the use pattern.
    Using the exposure assumptions described in this unit for short-
term exposures, EPA has concluded that the combined short- and
intermediate-term food, water, and residential exposures result in
aggregate MOEs of 470 for adult males; 510 for adult females (13-

49 years old); 220 for children (1-2 years old), short-term; and 210
for children (1-2 years old), intermediate-term. Residential exposure
for adults is intermediate-term dermal exposure from application of the
product plus post-application dermal exposure plus short- and
intermediate-term inhalation exposure from application of the product.
Short-term residential exposure for children is incidental oral
exposure. Intermediate-term residential exposure for children is post-
application dermal exposure and post-application incidental oral
exposure. Because EPA's level of concern for fluoxastrobin is a MOE of
100 or below, these residential MOEs are not of concern.
    4. Aggregate cancer risk for U.S. population. As is explained in
Unit III.A., the Agency has concluded that fluoxastrobin is not likely
to be carcinogenic to humans. Therefore cancer risk is not of concern
for this chemical.
    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 fluoxastrobin residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology (liquid chromatography/mass
spectrometry/mass spectrometry) is available to enforce the tolerance
expression. Method No. 00604 is available for plant commodities and
Method No. 00691 is available for animal 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

    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 U.N. 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. There are currently no
Codex or Canadian maximum residue limits (MRLs) or tolerances for
fluoxastrobin in or on sweet corn or wheat.

C. Revisions to Petitioned-For Tolerances

    EPA converted ``aspirated grain fractions'' to ``grain, aspirated
grain fractions''; ``sweet corn (kernels plus cob with husks removed)''
to ``corn, sweet, kernel plus cob with husks removed''; ``sweet corn,
forage'' to ``corn, sweet, forage''; ``sweet corn, stover'' to ``corn,
sweet, stover''; ``meat byproducts (cattle, goat, horse, sheep)'' to
``cattle, meat byproducts'', ``goat, meat byproducts'', ``horse, meat
byproducts'', and ``sheep, meat byproducts'' to conform them to the
Agency's Food and Feed Commodity Vocabulary. EPA also corrected the
tolerance expression for the meat byproduct commodities from
fluoxastrobin and its Z isomer to fluoxastrobin, its Z isomer, and its
phenoxy-hydroxypyrimidine metabolite, 6-(2-chlorophenoxy)-5-fluoro-4-
pyrimidinol. The proposed tolerance of 0.02 ppm in or on sweet corn,
kernels plus cob with husks removed has been reduced to 0.01 ppm in or
on corn, sweet, kernel plus cob with husks removed, based on the
highest observed residues in the sweet corn crop field trials and the
limit of quantitation of the residue method of 0.01 ppm for combined
residues of fluoxastrobin and its Z isomer. The proposed tolerance of
0.2 ppm in or on wheat, bran has been reduced to 0.15 ppm and the
proposed tolerance of 15 ppm in or on aspirated grain fractions has
been increased to 60 ppm in or on grain, aspirated grain fractions
because the wheat field trials indicate that the highest average field
trial residue of 0.11 ppm for wheat grain is 0.11 ppm and the wheat
processing study indicates that residues of fluoxastrobin may
concentrate in wheat, bran (1.3x) and aspirated grain fractions (518x).
This is also an increase in the pre-existing tolerance of 20 ppm for
fluoxastrobin in or on aspirated grain fractions.

V. Conclusion

    Therefore, tolerances are established for residues of
fluoxastrobin, (1E)-[2[[6-(2-chlorophenoxy)-5-fluoro-4-
pyrimidinyl]oxy]phenyl](5,6-dihydro-1,4,2-dioxazin-3-yl)methanone O-
methyloxime and its Z isomer, (1Z)-[2[[6-(2-chlorophenoxy)-5-fluoro-4-
pyrimidinyl]oxy]phenyl](5,6-dihydro-1,4,2-dioxazin-3-yl)methanone O-
methyloxime, in or on corn, sweet, forage at 13 ppm; corn, sweet,
kernel plus cob with husks removed at 0.01 ppm; corn, sweet, stover at
10 ppm; wheat, bran at 0.15 ppm; wheat, forage at 7.0 ppm; wheat, hay
at 17 ppm; and wheat, straw at 11 ppm. A pre-existing tolerance for the
residues of fluoxastrobin and its Z isomer in or on grain, aspirated
grain fractions is increased from 20 ppm to 60 ppm. Pre-existing
tolerances are also increased for the residues of fluoxastrobin, its Z
isomer, and its phenoxy-hydroxypyrimidine metabolite, 6-(2-
chlorophenoxy)-5-fluoro-4-pyrimidinol, in cattle, meat byproducts from
0.10 ppm to 0.20 ppm; in goat, meat byproducts from 0.10 ppm to 0.20
ppm; in horse, meat byproducts from 0.10 ppm to 0.20 ppm; and in sheep,
meat byproducts from 0.10 ppm to 0.20 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: September 24, 2010.
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.

.6090
2. Section 180.609 is amended by:
    i. Removing ``Aspirated grain fractions'' in paragraph (a)(1) in
the table;
    ii. Adding alphabetically the following commodities to the table in
paragraph (a)(1); and
    iii. Revising the entries for Cattle, meat byproducts; Goat, meat
byproducts; Horse, meat byproducts; and Sheep, meat byproducts in the
table in paragraph (a)(2).
    The amendments read as follows:

Sec.  180.609  Fluoxastrobin; tolerances for residues.

    (a) General. (1) * * *

------------------------------------------------------------------------
                      Commodity                        Parts per million
------------------------------------------------------------------------
                                * * * * *
Corn, sweet, forage..................................                 13
Corn, sweet, kernel plus cob with husks removed......               0.01
Corn, sweet, stover..................................                 10
Grain, aspirated grain fractions.....................                 60
                                * * * * *
Wheat, bran..........................................               0.15
Wheat, forage........................................                7.0
Wheat, hay...........................................                 17
Wheat, straw.........................................                 11
------------------------------------------------------------------------

    (2) * * *

------------------------------------------------------------------------
                      Commodity                        Parts per million
------------------------------------------------------------------------
                                * * * * *
Cattle, meat byproducts..............................               0.20
                                * * * * *
Goat, meat byproducts................................               0.20
                                * * * * *
Horse, meat byproducts...............................               0.20
                                * * * * *
Sheep, meat byproducts...............................               0.20
------------------------------------------------------------------------

* * * * *

[FR Doc. 2010-24575 Filed 9-29-10; 8:45 am]
BILLING CODE 6560-50-S


[Federal Register: August 13, 2008 (Volume 73, Number 157)]
[Notices]
[Page 47186-47188]
[DOCID:fr13au08-75]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2008-0046; FRL-8375-8]

Notice of Receipt; Several Pesticide Petitions Filed for Residues
of Pesticide Chemicals in or on Various Commodities

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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

SUMMARY: This notice announces the Agency's receipt of several initial
filing of pesticide petitions proposing the establishment or
modification of regulations for residues of pesticide chemicals in or
on various commodities.

DATES: Comments must be received on or before September 12, 2008.

ADDRESSES: Submit your comments, identified by docket identification
(ID) number and the pesticide petition number (PP) of interest as
identified in the body of this document, by one of the following
methods:
     Federal eRulemaking Portal:  http://www.regulations.gov.
Follow the on-line instructions for submitting comments.
     Mail: Office of Pesticide Programs (OPP) Regulatory Public
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460-0001.
     Delivery: OPP Regulatory Public Docket (7502P),
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only
accepted during the Docket's normal hours of operation (8:30 a.m. to 4
p.m., Monday through Friday, excluding legal holidays). Special
arrangements should be made for deliveries of boxed information. The
Docket Facility telephone number is<PHONE_NUMBER>.
    Instructions: Direct your comments to the docket ID number and the
pesticide petition number of interest as identified in the body of this
document. EPA's policy is that all comments received will be included
in the docket without change and may be made available on-line at
http://www.regulations.gov, including any personal information
provided, unless the comment includes information claimed to be
Confidential Business Information (CBI) or other information whose
disclosure is restricted by statute. Do not submit information that you
consider to be CBI or otherwise protected through regulations.gov or e-
mail. The regulations.gov website is an ``anonymous access'' system,
which means EPA will not know your identity

or contact information unless you provide it in the body of your
comment. If you send an e-mail comment directly to EPA without going
through regulations.gov, your e-mail address will be automatically
captured and included as part of the comment that is placed in the
docket and made available on the Internet. If you submit an electronic
comment, EPA recommends that you include your name and other contact
information in the body of your comment and with any disk or CD-ROM you
submit. If EPA cannot read your comment due to technical difficulties
and cannot contact you for clarification, EPA may not be able to
consider your comment. Electronic files should avoid the use of special
characters, any form of encryption, and be free of any defects or
viruses.
    Docket: All documents in the docket are listed in the docket index
available in http://www.regulations.gov. Although listed in the index,
some information is not publicly available, e.g., CBI or other
information whose disclosure is restricted by statute. Certain other
material, such as copyrighted material, is not placed on the Internet
and will be publicly available only in hard copy. Publicly available
docket materials are available electronically 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 hours of operation of this
Docket Facility are from 8:30 a.m. to 4 p.m., Monday through Friday,
excluding legal holidays. The Docket Facility telephone number is (703)
305-5805.

FOR FURTHER INFORMATION CONTACT: The person listed at the end of the
pesticide petition summary of interest, Office of Pesticide Programs,
Registration Division (7505P), Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington, DC 20460-0001.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
Potentially affected entities may include, but are not limited to:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).
    This listing is not intended to be exhaustive, but rather provides
a guide for readers regarding entities likely to be affected by this
action. Other types of entities not listed in this unit could also be
affected. The North American Industrial Classification System (NAICS)
codes have been provided to assist you and others in determining
whether this action might apply to certain entities. If you have any
questions regarding the applicability of this action to a particular
entity, consult the person listed at the end of the pesticide petition
summary of interest.

B. What Should I Consider as I Prepare My Comments for EPA?

     1. Submitting CBI. Do not submit this information to EPA through
regulations.gov or e-mail. Clearly mark the part or all of the
information that you claim to be CBI. For CBI information in a disk or
CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM as
CBI and then identify electronically within the disk or CD-ROM the
specific information that is claimed as CBI. In addition to one
complete version of the comment that includes information claimed as
CBI, a copy of the comment that does not contain the information
claimed as CBI must be submitted for inclusion in the public docket.
Information so marked will not be disclosed except in accordance with
procedures set forth in 40 CFR part 2.
     2. Tips for preparing your comments. When submitting comments,
remember to:
    i. Identify the document by docket ID number and other identifying
information (subject heading, Federal Register date and page number).
    ii. Follow directions. The Agency may ask you to respond to
specific questions or organize comments by referencing a Code of
Federal Regulations (CFR) part or section number.
    iii. Explain why you agree or disagree; suggest alternatives and
substitute language for your requested changes.
    iv. Describe any assumptions and provide any technical information
and/or data that you used.
    v. If you estimate potential costs or burdens, explain how you
arrived at your estimate in sufficient detail to allow for it to be
reproduced.
    vi. Provide specific examples to illustrate your concerns and
suggest alternatives.
    vii. Explain your views as clearly as possible, avoiding the use of
profanity or personal threats.
    viii. Make sure to submit your comments by the comment period
deadline identified.
    3. Environmental justice. EPA seeks to achieve environmental
justice, the fair treatment and meaningful involvement of any group,
including minority and/or low income populations, in the development,
implementation, and enforcement of environmental laws, regulations, and
policies. To help address potential environmental justice issues, the
Agency seeks information on any groups or segments of the population
who, as a result of their location, cultural practices, or other
factors, may have atypical or disproportionately high and adverse human
health impacts or environmental effects from exposure to the pesticides
discussed in this document, compared to the general population.

II. Docket ID Numbers

    When submitting comments, please use the docket ID number and the
pesticide petition number of interest, as shown in the table.

------------------------------------------------------------------------
                 PP Number                        Docket ID Number
------------------------------------------------------------------------
PP 8E7347                                   EPA-HQ-OPP-2008-0554
------------------------------------------------------------------------
PP 8E7365                                   EPA-HQ-OPP-2008-0556
------------------------------------------------------------------------
PP 5F4469                                   EPA-HQ-OPP-2008-0276
------------------------------------------------------------------------
PP 8F7369                                   EPA-HQ-OPP-2008-0526
------------------------------------------------------------------------
PP 8F7383                                   EPA-HQ-OPP-2008-0557
------------------------------------------------------------------------
PP 8E7347                                   EPA-HQ-OPP-2008-0554
------------------------------------------------------------------------

III. What Action is the Agency Taking?

    EPA is announcing its receipt of several pesticide petitions filed
under section 408 of the Federal Food, Drug, and Cosmetic Act (FFDCA),
21 U.S.C. 346a, proposing the establishment or modification of
regulations in 40 CFR part 180 for residues of pesticide chemicals in
or on various food commodities. EPA has determined that the pesticide
petitions described in this document contain the data or information
prescribed in FFDCA section 408(d)(2); however, EPA has not fully
evaluated the sufficiency of the submitted data at this time or whether
the data support granting of the pesticide petitions. Additional data
may be needed before EPA can make a final determination on these
pesticide petitions.
    Pursuant to 40 CFR 180.7(f), a summary of the petition that is the
subject of this notice, which was prepared by the petitioner as
required by 40 CFR 180.7(b)(1), is included in the docket for this
rulemaking at http://www.regulations.gov. As specified in

FFDCA section 408(d)(3), (21 U.S.C. 346a(d)(3)), EPA is publishing
notice of the petition so that the public has an opportunity to comment
on this request for the establishment or modification of regulations
for residues of pesticides in or on food commodities. Further
information on the petition may be obtained through the petition
summary referenced above.

New Tolerances

     1. PP 8E7347. Interregional Research Project Number 4 (IR-4), IR-4
Project Headquarters, Rutgers, The State University of New Jersey, 500
College Rd. East, Suite 201 W, Princeton, NJ 08450, proposes to
establish a tolerance for residues of the insecticide etoxazole, 2-
(2,6-difluorophenyl)-4-[4-(1,1-dimethylethyl)-2-ethoxyphenyl]-4,5-
dihydrooxazole, in or on food commodities fruit, stone, group 12,
except plum at 1.0 parts per million (ppm); plum at 0.12 ppm; plum,
prune, dried at 0.4 ppm; cucumber at 0.02 ppm; tomato at 0.25 ppm;
spearmint, tops at 10 ppm; peppermint, tops at 10 ppm; peppermint, oil
at 20 ppm; and spearmint, oil at 20 ppm. Practical analytical methods
for detecting and measuring levels of etoxazole have been developed and
validated in/on all appropriate agricultural commodities and respective
processing fractions. The level of quantitation (LOQ) of etoxazole in
the methods is 0.02 ppm which will allow monitoring of food with
residues at the levels proposed for the tolerances. Contact: Sidney
Jackson,<PHONE_NUMBER><EMAIL_ADDRESS>     2. PP 8E7365. IR-4, IR-4 Project Headquarters, Rutgers, The State
University of New Jersey, 500 College Rd. East, Suite 201 W, Princeton,
NJ 08450, proposes to establish a tolerance for residues of the
insecticide fenpyroximate, (E)-1,1-dimethylethyl 4-[[[[(1,3-dimethyl-5-
phenoxy-1H-pyrazol-4-yl) methylene] amino]oxy]methyl] benzoate and its
Z-isomer, (Z)-1,1-dimethylethyl 4-[[[[(1,3-dimethyl-5-phenoxy-1H-
pyrazol-4-yl)methylene] amino]oxy] methyl]benzoate] in or on food
commodities vegetables, fruiting, group 08 at 0.20 ppm; okra at 0.20
ppm; melon subgroup 09A at 0.03 ppm; and cucumber at 0.05 ppm. Based
upon the metabolism of fenpyroximate in plants and the toxicology of
the parent and metabolites, quantification of the parent, fenpyroximate
and the z-isomer, combined as fenpyroximate is sufficient to determine
toxic residues in plants. As a result, an enforcement method has been
developed which involves extraction of fenpyroximate from crops with
acetone, filtration, partitioning and cleanup, and analysis by gas
chromatography using a nitrogen/phosphorous detector. The method has
undergone independent laboratory validation as required by PR Notice
88-5 and 96-1. This summary has been prepared by Nichino America, Inc.,
Wilmington, DE 19808, the registrant. Contact: Sidney Jackson, (703)
305-7610<EMAIL_ADDRESS>     3. PP 5F4469. Syngenta Crop Protection, Inc., PO Box 18300,
Greensboro, NC 27419, proposes to establish a tolerance for residues of
the herbicide prosulfuron, 1-(4-methoxy-6-methyl-triazin-2-yl)-3-[2-
(3,3,3-trifluoropropyl)-phenylsulfonyl]-urea] in or on food commodities
field and popcorn grain, fodder and forage at 0.01 ppm; cereal grains
group (except rice and wild rice), fodder at 0.01 ppm; forage at 0.10
ppm; grain at 0.01 ppm; hay at 0.20 ppm; straw at 0.02 ppm; cattle,
goat, hog, horse, sheep fat, kidney, liver, meat, and meat byproducts
at 0.05 ppm; and milk at 0.01 ppm. Adequate analytical methods exist
for the detection and measurement of residue levels of prosulfuron in
or on raw and processed commodities of cereal grains, and for meat,
milk and eggs. The LOQ is 0.01 ppm for crop commodities, processed
fractions and milk, and 0.05 ppm for meat and eggs. The method is based
on commodity-specific cleanup procedures followed by determination by
high performance liquid chromatography (HPLC) with ultraviolet (UV)
detection. Contact: Hope Johnson,<PHONE_NUMBER><EMAIL_ADDRESS>     4. PP 8F7369. Dow AgroSciences, LLC., 9330 Zionsville Rd.,
Indianapolis, IN 46268, proposes to establish a tolerance for residues
of the herbicide penoxsulam in or on food commodities nut, tree, group
14 at 0.01 ppm; grape at 0.01 ppm; almond, hulls at 0.01 ppm; and
pistachio at 0.01 ppm. In the Magnitude of Residue (MOR) studies
conducted in grapes, almonds and pecans to support tolerances proposed
in this petition, residues of penoxsulam were determined using the
analytical method GRM 04.09. The final solution was analyzed by liquid
chromatography with positive-ion electrospray tandem mass spectrometry
(LC/MS/MS). The limit of detection (LOD) and LOQ are 0.003 [micro]g/g
and 0.010 [micro]g/g, respectively. Contact: Philip Errico, (703) 305-
6663<EMAIL_ADDRESS>     5. PP 8F7383. Gowan Company, PO Box 5569, Yuma, AZ, 85366-5569,
proposes to establish a tolerance for residues of the insecticide
phosmet in or on food commodities almond and pistachio nutmeats at 0.3
ppm; almond hulls at 50 ppm. Appropriate data collection and
enforcement analytical methods are available to detect phosmet and its
oxygen analog in plant and animal commodities. The Pesticide Analytical
Manual (PAM) lists a gas chromatography method with flame photometric
detection (GC/FPD) and a GC method with flame ionization as Methods II
and III, respectively, for tolerance enforcement. Contact: Ann Sibold,
(703) 305-6502<EMAIL_ADDRESS>
Amendment to Existing Tolerance

     1. PP 8E7347. IR-4, IR-4 Project Headquarters, Rutgers, The State
University of New Jersey, 500 College Rd. East, Suite 201 W, Princeton,
NJ 08450, proposes to amend the tolerance in 40 CFR 180.593 for
residues of the insecticide etoxazole, 2-(2,6-difluorophenyl)-4-[4-
(1,1-dimethylethyl)-2-ethoxyphenyl]-4,5-dihydrooxazole, in or on the
food commodity cherry at 1.0 ppm after the tolerance for fruit, stone,
group 12, except plum at 1.0 ppm is established for residues of
etoxazole. Contact: Sidney Jackson,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
List of Subjects

    Environmental protection, Agricultural commodities, Feed additives,
Food additives, Pesticides and pests, Reporting and recordkeeping
requirements.

    Dated: August 4, 2008.
Donald R. Stubbs,
Acting Director, Registration Division, Office of Pesticide Programs.
[FR Doc. E8-18609 Filed 8-12-08; 8:45 am]

BILLING CODE 6560-50-S


[Federal Register Volume 84, Number 101 (Friday, May 24, 2019)]
[Notices]
[Pages 24136-24137]
[FR Doc No: 2019-10904]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OAR-2014-0738 and EPA-HQ-OAR-2010-0682; FRL-9993-82-OAR]

Notice of Final Approval for an Alternative Means of Emission
Limitation at Shell Oil Products U.S. Martinez Refinery

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice; final approval.

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

SUMMARY: This document announces our approval of the alternative means
of emission limitation (AMEL) request under the Clean Air Act (CAA)
submitted by Shell Oil Products U.S. Martinez Refinery (Shell Martinez)
to operate a multi-point ground flare (MPGF) at a refinery in Martinez,
California. The EPA received one non-substantive comment that appears
to support the request; we received no adverse comment on the request.
This approval document specifies the operating conditions and
monitoring, recordkeeping, and reporting requirements that these
facilities must follow to demonstrate compliance with the approved
AMEL.

DATES: The approval of the AMEL request from Shell Martinez to operate
an MPGF at the Shell Martinez refinery, as specified in this document,
is approved on May 24, 2019.

ADDRESSES: The Environmental Protection Agency (EPA) has established a
docket for this action under Docket ID No. EPA-HQ-OAR-2014-0738. All
documents in the docket are listed on the https://www.regulations.gov/
website. Although listed, some information is not publicly available,
e.g., Confidential Business Information 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 https://www.regulations.gov/ or in hard copy at the EPA Docket Center, EPA WJC
West Building, Room Number 3334, 1301 Constitution Ave. NW, Washington,
DC. The Public Reading Room hours of operation are 8:30 a.m. to 4:30
p.m.

Eastern Standard Time (EST), Monday through Friday. The telephone
number for the Public Reading Room is<PHONE_NUMBER>, and the telephone
number for the Docket Center is<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: For questions about this final action,
contact Ms. Angie Carey, Sector Policies and Programs Division (E143-
01), Office of Air Quality Planning and Standards, U.S. Environmental
Protection Agency, Research Triangle Park, North Carolina 27711;
telephone number:<PHONE_NUMBER>; fax number:<PHONE_NUMBER>; and email
address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:
    Preamble acronyms and abbreviations. We use multiple acronyms and
terms in this preamble. While this list may not be exhaustive, to ease
the reading of this preamble and for reference purposes, the EPA
defines the following terms and acronyms here:

AMEL alternative means of emission limitation
BTU/scf British thermal units per standard cubic foot
CFR Code of Federal Regulations
DCU delayed coking unit
EPA Environmental Protection Agency
MACT maximum achievable control technology
MPGF multi-point ground flare
NESHAP national emission standards for hazardous air pollutants

    Organization of this document. The information in this document is
organized as follows:

I. Background
    A. Summary
    B. Regulatory Flare Requirements
II. Summary of Public Comments on the AMEL Request
III. AMEL for the MPGF

I. Background

A. Summary

    In a Federal Register document dated March 11, 2019, the EPA
provided public notice and solicited comment on the request under the
CAA by Shell Martinez to operate an MPGF at a refinery in Martinez,
California (see 84 FR 8715). In that document, the EPA solicited
comment on all aspects of the AMEL request, including the operating
conditions specified in that document that are necessary to achieve a
reduction in emissions of volatile organic compounds and organic
hazardous air pollutants at least equivalent to the reduction in
emissions required by the maximum achievable control technology (MACT)
requirements for Petroleum Refineries at 40 CFR 63.670(d) that apply to
emission sources that would be controlled by this MPGF. Shell Martinez
requested the AMEL for its MPGF that controls emissions from its
delayed coking unit (DCU). Shell Martinez submitted an AMEL request to
operate a flare with tip exit velocities greater than those allowed in
40 CFR 63.670(d) while achieving >= 96.5-percent combustion efficiency
and 98-percent destruction efficiency.
    This action provides a summary of our approval of this AMEL
request.

B. Regulatory Flare Requirements

    Shell Martinez provided the information specified in the flare AMEL
framework set forth in the Petroleum Refinery MACT at 40 CFR 63.670(r)
to support its AMEL request. Shell Martinez is seeking an AMEL to
operate its MPGF during upset emergency conditions. This DCU is subject
to the Petroleum Refinery MACT, 40 CFR part 63, subpart CC;
accordingly, the request followed the AMEL framework specified in 40
CFR part 63, subpart CC, at 40 CFR 63.670(r).

II. Summary of Public Comments on the AMEL Request

    The Agency received one non-substantive comment that appears to
support the initial notice. No adverse comment was received on the
request.

III. AMEL for the MPGF

    The EPA is approving the AMEL request by Shell Martinez to operate
an MPGF with tip exit velocities greater than those allowed in 40 CFR
63.670(d) while achieving >=96.5-percent combustion efficiency and 98-
percent destruction efficiency. We are also establishing in this notice
the operating conditions for this MPGF as part of this approval. These
operating conditions, which are the same as those set forth in the
March 11, 2019, document, will ensure that this flare will achieve
emission reductions at least equivalent to those achieved by flares
complying with the relevant requirements in the Petroleum Refinery
MACT. The operating conditions are as follows:
    (1) The MPGF must be operated according to the requirements of the
Petroleum Refinery MACT, including 40 CFR 63.670 and 63.671, except
that all references to a combustion zone heating value of 270 British
thermal units per standard cubic feet (BTU/scf) are replaced with a
value of 800 BTU/scf and the flare tip velocity requirements of 40 CFR
63.670(d) do not apply.
    (2) Each stage that cross-lights must have at least two pilots with
a continuously lit pilot flame.
    (3) The operator of the DCU MPGF system shall install and operate
pressure monitor(s) on the main flare header, as well as a valve
position indicator monitoring system capable of monitoring and
recording the position for each staging valve to ensure that the flare
operates at normal maximum operating pressure of 15 pounds per square
inch gauge as described in the AMEL application. The pressure monitor
shall meet the requirements in Table 13 of 40 CFR 63, subpart CC.
    (a) The owner or operator of the Shell Martinez DCU MPGF shall meet
the reporting requirements in the Petroleum Refinery MACT in 40 CFR
63.655(g)(11)(i)-(iii). In addition, the Shell Martinez MPGF
notification shall also include records specified in sections (i)-(ii)
below.
    (i) Records of when the pressure monitor(s) on the main flare
header show the flare burners are operating outside the range of tested
conditions or outside the range of the manufacturer's specifications.
Indicate the date and time for each period, the pressure measurement,
the stage(s) and number of flare burners affected, and the range of
tested conditions or manufacturer's specifications.
    (ii) Records of when the staging valve position indicator
monitoring system indicates that a stage of the flare should not be in
operation and is, or that a stage of the flare should be in operation
and is not. Indicate the date and time for each such period, whether
the stage was supposed to be open but was closed, or vice versa, and
the stage(s) and number of flare burners affected.

    Dated: May 20, 2019.
Panagiotis Tsirigotis,
Director, Office of Air Quality Planning and Standards.
[FR Doc. 2019-10904 Filed 5-23-19; 8:45 am]
 BILLING CODE 6560-50-P