Fluazinam; Pesticide Tolerances, 3026-3029 [2011-1019]
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Federal Register / Vol. 76, No. 12 / Wednesday, January 19, 2011 / Rules and Regulations
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[FR Doc. 2011–484 Filed 1–18–11; 8:45 am]
BILLING CODE 6560–50–P
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
[EPA–HQ–OPP–2009–0032; FRL–8859–3]
Fluazinam; Pesticide Tolerances
Environmental Protection
Agency (EPA).
ACTION: Final rule.
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AGENCY:
This regulation establishes
tolerances for residues of fluazinam in
or on multiple commodities which are
identified and discussed later in this
document. Interregional Research
Project Number 4 (IR–4) requested these
SUMMARY:
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tolerances under the Federal Food,
Drug, and Cosmetic Act (FFDCA).
DATES: This regulation is effective
January 19, 2011. Objections and
requests for hearings must be received
on or before March 21, 2011, and must
be filed in accordance with the
instructions provided in 40 CFR part
178 (see also Unit I.C. of the
SUPPLEMENTARY INFORMATION).
ADDRESSES: EPA has established a
docket for this action under docket
identification (ID) number EPA–HQ–
OPP–2009–0032. All documents in the
docket are listed in the docket index
available at https://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
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the Internet and will be publicly
available only in hard copy form.
Publicly available docket materials are
available in the electronic docket at
https://www.regulations.gov, or, if only
available in hard copy, at the OPP
Regulatory Public Docket in Rm. S–
4400, One Potomac Yard (South Bldg.),
2777 S. Crystal Dr., Arlington, VA. The
Docket Facility is open from 8:30 a.m.
to 4 p.m., Monday through Friday,
excluding legal holidays. The Docket
Facility telephone number is (703) 305–
5805.
FOR FURTHER INFORMATION CONTACT:
Laura Nollen, Registration Division
(7505P), Office of Pesticide Programs,
Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington,
DC 20460–0001; telephone number:
(703) 305–7390; e-mail address:
nollen.laura@epa.gov.
SUPPLEMENTARY INFORMATION:
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Federal Register / Vol. 76, No. 12 / Wednesday, January 19, 2011 / Rules and Regulations
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.
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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 https://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–2009–0032 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 March 21, 2011. 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
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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–2009–0032, by one of
the following methods:
• Federal eRulemaking Portal: https://
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
(703) 305–5805.
II. Summary of Petitioned-For
Tolerance
In the Federal Register of August 19,
2009 (74 FR 41898) (FRL–8426–7), EPA
issued a notice pursuant to section
408(d)(3) of FFDCA, 21 U.S.C.
346a(d)(3), announcing the filing of two
pesticide petitions: PP 9E7570 by
Interregional Research Project Number 4
(IR–4), 500 College Rd. East, Suite 201
W, Princeton, NJ 08540; and PP 9F7571
by ISK Biosciences Corporation, 7470
Auburn Rd., Suite A, Concord, OH
44077. PP 9E7570 requested that 40 CFR
180.574 be amended by establishing
tolerances for residues of the fungicide
fluazinam, (3-chloro-N-[3-chloro-2,6dinitro-4-(trifluoromethyl)phenyl]-5(trifluoromethyl)-2-pyridinamine), in or
on carrot, root at 0.8 parts per million
(ppm). PP 9F7571 requested that 40 CFR
180.574 be amended by establishing
tolerances for residues of the fungicide
fluazinam and the metabolite AMGT, (3[[4-amino-3-[[3-chloro-5(trifloromethyl)-2-pyridinyl]amino]-2nitro-6-(trifluoromethyl) phenyl] thio]-2(beta-D-glucopyranosyloxy) propionic
acid), in or on the raw agricultural
commodity apple at 1.7 ppm and wet
apple pomace at 5.0 ppm, and by
establishing tolerances for the combined
residues of fluazinam and its
metabolites, DAPA and AMPA, in the
following animal tissues and meat
byproducts at 0.03 ppm: Cattle, fat;
cattle, kidney; cattle, liver; cattle, meat;
cattle, meat byproducts; goat, fat; goat,
kidney; goat, liver; goat, meat; goat,
meat byproducts; horse, fat; horse,
kidney; horse, liver; horse, meat; horse,
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meat byproducts; milk; sheep, fat;
sheep, kidney; sheep, liver; sheep, meat;
and sheep, meat byproducts. PP 9E7570
referenced a summary of the petition
prepared on behalf of IR–4 by ISK
Biosciences, the registrant; PP 9F7571
referenced a summary of the petition
prepared by the registrant, ISK
Biosciences. Petition summaries are
available in the docket, https://
www.regulations.gov. There were no
comments received in response to the
notices of filing.
Based upon review of the data
supporting the petition, EPA has revised
several proposed tolerances and has
determined that several other proposed
tolerances are not necessary. 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 fluazinam
including exposure resulting from the
tolerances established by this action.
EPA’s assessment of exposures and risks
associated with fluazinam follows.
In the Federal Register of May 12,
2010 (75 FR 26662) (FRL–8824–5), EPA
published a Final Rule establishing
tolerances for residues of the fungicide
fluazinam in or on bushberry subgroup
13–07B at 7.0 pm; lettuce, head at 0.02
ppm; lettuce, leaf at 2.0 ppm; and onion,
bulb, subgroup 3–07A at 0.20 ppm,
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Federal Register / Vol. 76, No. 12 / Wednesday, January 19, 2011 / Rules and Regulations
associated with PP 8E7506. When the
Agency conducted the risk assessment
in support of the May 12, 2010 tolerance
action, it considered the use of
fluazinam in or on carrot, root (PP
9E7570), apples and wet apple pomace
(PP 9F7571), and fluazinam and its
metabolites AMPA and DAPA in the
following animal tissues and meat
byproducts: Cattle, fat; cattle, kidney;
cattle, liver; cattle, meat; cattle, meat
byproducts; goat, fat; goat, kidney; goat,
liver; goat, meat; goat, meat byproducts;
horse, fat; horse, kidney; horse, liver;
horse, meat; horse, meat byproducts;
milk; sheep, fat; sheep, kidney; sheep,
liver; sheep, meat; and sheep, meat
byproducts (PP 9F7571). However,
because of data deficiencies identified
during the course of review, EPA was
not able to recommend in favor of the
tolerances associated with PP 9E7570
and PP 9F7571. The deficiencies related
to an apple processing study, a cattle
feeding study, and the analytical
method for the metabolites AMPA and
DAPA in fat, liver, and kidney.
In response to the noted data
deficiencies, the registrant provided
additional data for the apple processing
study and a rebuttal to the cattle feeding
study; after further review, EPA has
determined that these studies are now
acceptable. Additionally, in response to
the analytical method data deficiency,
the registrant submitted a revised
analytical method and independent
laboratory validation, which EPA has
concluded is adequate as an
enforcement method for residues of
fluazinam, AMPA, and DAPA and their
sulfamate conjugates in kidney, liver,
and fat. Detailed considerations
regarding EPA’s resolution of these data
deficiencies are discussed in the
document, ‘‘Fluazinam, Petitions for the
Establishment of Tolerances and
Registration of New Uses on Apples and
Carrots. HED’s Conclusions Regarding
Registrant’s Response to Data
Deficiencies’’ which is available at
https://regulations.gov in docket EPA–
HQ–OPP–2009–0032.
Since EPA considered the additional
uses proposed by PP 9E7570 and PP
9F7571 in its most recent risk
assessments, establishing tolerances on
these commodities will not change the
estimated aggregate risks resulting from
use of fluazinam, as discussed in the
May 12, 2010 (75 FR 26662) (FRL–8824–
5) Federal Register. Therefore, EPA
concludes that there is a reasonable
certainty that no harm will result to the
general population, and to infants and
children from aggregate exposure to
fluazinam residues. Refer to the May 12,
2010 Federal Register document,
available at https://www.regulations.gov,
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for a detailed discussion of the aggregate
risk assessments and determination of
safety. EPA relies upon those risk
assessments and the findings made in
the Federal Register document in
support of this action.
IV. Other Considerations
A. Analytical Enforcement Methodology
An adequate enforcement
methodology, gas chromatography with
electron capture detection (GC/ECD), is
available to enforce the tolerance
expression for plant commodities. For
livestock commodities, an adequate
enforcement method, liquid
chromatography/mass spectrometry/
mass spectrometry (LC/MS/MS), is
available to enforce the tolerance
expression for residues of fluazinam,
AMPA, and DAPA and their sulfamate
conjugates in bovine liver, fat, and milk.
The methods may be requested from:
Chief, Analytical Chemistry Branch,
Environmental Science Center, 701
Mapes Rd., Ft. Meade, MD 20755–5350;
telephone number: (410) 305–2905; email address: residuemethods@epa.gov.
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.
The Codex has not established MRLs
for fluazinam in or on apple or carrot.
However, these tolerance petitions have
been evaluated as a joint review with
Canada, and the United States and
Canada have agreed that the appropriate
tolerance levels for carrot, roots is 0.70
ppm and apple is 2.0 ppm.
C. Revisions to Petitioned-For
Tolerances
Based on analysis of the data
supporting the petitions, EPA has
revised the proposed tolerances in or on
carrot, roots from 0.8 ppm to 0.70 ppm;
apples from 1.7 ppm to 2.0 ppm; and
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the following proposed tolerances from
0.03 ppm to 0.05 ppm: Cattle, fat; cattle,
meat byproducts; goat, fat; goat, meat
byproducts; horse, fat; horse, meat
byproducts; sheep, fat; and sheep, meat
byproducts. EPA revised these tolerance
levels based on analysis of the residue
data using the Agency’s Tolerance
Spreadsheet in accordance with the
Agency’s ‘‘Guidance for Setting
Pesticide Tolerances Based on Field
Trial Data.’’
Additionally, based on the results of
an animal feeding study and the
calculated dietary burden for dairy
cattle, EPA has determined that the
proposed tolerances of 0.03 ppm for the
meat of cattle, goat, horse, and sheep are
not necessary. The Agency has further
determined that the proposed tolerances
of 0.03 ppm for the liver and kidney of
cattle, goat, horse, and sheep are not
necessary because tolerances are being
established for meat byproducts of
cattle, goat, horse, and sheep; EPA
previously determined that individual
tolerances are not needed for liver and
kidney when a tolerance is being
established for meat byproducts.
V. Conclusion
Therefore, tolerances are established
for residues of fluazinam, (3-chloro-N[3-chloro-2,6-dinitro-4(trifluoromethyl)phenyl]-5(trifluoromethyl)-2-pyridinamine), in or
on carrot, roots at 0.70 ppm; apple at 2.0
ppm; apple, wet pomace at 5.0 ppm;
and tolerances are established for
residues of fluazinam and its
metabolites AMPA and DAPA in or on
cattle, fat at 0.05 ppm; cattle, meat
byproducts at 0.05 ppm; goat, fat at 0.05
ppm; goat, meat byproducts at 0.05
ppm; horse, fat at 0.05 ppm; horse, meat
byproducts at 0.05 ppm; sheep, fat at
0.05 ppm; and sheep, meat byproducts
at 0.05 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
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Federal Register / Vol. 76, No. 12 / Wednesday, January 19, 2011 / Rules and Regulations
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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) (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
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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: January 7, 2011.
Daniel J. Rosenblatt,
Acting Director, Registration Division, Office
of Pesticide Programs.
Therefore, 40 CFR chapter I is
amended as follows:
PART 180—[AMENDED]
Parts per
million
Commodity
Cattle, fat ....................................
Cattle, meat byproducts .............
Goat, fat ......................................
Goat, meat byproducts ...............
Horse, fat ....................................
Horse, meat byproducts .............
Sheep, fat ...................................
Sheep, meat byproducts ............
*
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*
0.05
0.05
0.05
0.05
0.05
0.05
0.05
0.05
*
[FR Doc. 2011–1019 Filed 1–18–11; 8:45 am]
BILLING CODE 6560–50–P
DEPARTMENT OF THE INTERIOR
Fish and Wildlife Service
50 CFR Part 17
[Docket No. FWS–R6–ES–2008–0001;
92220–1113–0000–C6]
RIN 1018–AU67
1. The authority citation for part 180
continues to read as follows:
■
Authority: 21 U.S.C. 321(q), 346a and 371.
2. Section 180.574 is amended by
alphabetically adding the following
commodities to the table in paragraph
(a)(1), and by adding paragraph (a)(3) to
read as follows:
■
§ 180.574 Fluazinam; tolerances for
residues.
Endangered and Threatened Wildlife
and Plants; Removal of Erigeron
maguirei (Maguire Daisy) From the
Federal List of Endangered and
Threatened Plants; Availability of Final
Post-Delisting Monitoring Plan
Fish and Wildlife Service,
Interior.
ACTION: Final rule.
AGENCY:
We, the U.S. Fish and
Wildlife Service (Service/USFWS), are
removing the plant Erigeron maguirei
Parts per
Commodity
(commonly referred to as Maguire daisy)
million
from the List of Endangered and
Threatened Plants. The best scientific
Apple .........................................
2.0
and commercial data available indicate
Apple, wet pomace ...................
5.0
that this species has recovered and no
longer meets the definition of
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*
Carrot, roots ..............................
0.70 endangered or threatened under the
Endangered Species Act of 1973, as
amended (ESA). Our review of the
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*
status of this species shows that
populations are stable, threats are
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addressed, and adequate regulatory
(3) Tolerances are established for
mechanisms are in place so that the
residues of fluazinam (3-chloro-N-[3species is not currently, and is not likely
chloro-2,6-dinitro-4to again become, an endangered species
(trifluoromethyl)phenyl]-5within the foreseeable future in all or a
(trifluoromethyl)-2-pyridinamine),
significant portion of its range. Finally,
including its metabolites and
degradates, in or on the commodities in we announce the availability of the final
post-delisting monitoring plan for
the table below. Compliance with the
tolerance levels specified below is to be Maguire daisy.
DATES: This rule becomes effective on
determined by measuring only
fluazinam, AMPA (2-(6-amino-3-chloro- February 18, 2011.
a,a,a-trifluoro-2-nitro-p-toluidino)-3ADDRESSES: Copies of the final postchloro-5-(trifluoromethyl) pyridine),
delisting monitoring plan are available
DAPA (3-chloro-2-(2,6-diamino-3by request from the Utah Field Office
chloro-a,a,a.-trifluoro-p-toluidino)-5(see FOR FURTHER INFORMATION CONTACT)
(trifluoromethyl)pyridine), and their
or online at: https://www.fws.gov/
sulfamate conjugates.
mountain-prairie/species/plants/
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(a) General. (1) * * *
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SUMMARY:
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]]>Agencies
[Federal Register Volume 76, Number 12 (Wednesday, January 19, 2011)]
[Rules and Regulations]
[Pages 3026-3029]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-1019]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2009-0032; FRL-8859-3]
Fluazinam; Pesticide Tolerances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation establishes tolerances for residues of
fluazinam in or on multiple commodities which are identified and
discussed later in this document. Interregional Research Project Number
4 (IR-4) requested these tolerances under the Federal Food, Drug, and
Cosmetic Act (FFDCA).
DATES: This regulation is effective January 19, 2011. Objections and
requests for hearings must be received on or before March 21, 2011, and
must be filed in accordance with the instructions provided in 40 CFR
part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).
ADDRESSES: EPA has established a docket for this action under docket
identification (ID) number EPA-HQ-OPP-2009-0032. All documents in the
docket are listed in the docket index available at https://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 https://www.regulations.gov, or, if only available in hard
copy, at the OPP Regulatory Public Docket in Rm. S-4400, One Potomac
Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The Docket
Facility is open from 8:30 a.m. to 4 p.m., Monday through Friday,
excluding legal holidays. The Docket Facility telephone number is (703)
305-5805.
FOR FURTHER INFORMATION CONTACT: Laura Nollen, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone
number: (703) 305-7390; e-mail address: nollen.laura@epa.gov.
SUPPLEMENTARY INFORMATION:
[[Page 3027]]
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 https://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-2009-0032 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
March 21, 2011. 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-2009-0032, by one of the following methods:
Federal eRulemaking Portal: https://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 (703) 305-5805.
II. Summary of Petitioned-For Tolerance
In the Federal Register of August 19, 2009 (74 FR 41898) (FRL-8426-
7), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21
U.S.C. 346a(d)(3), announcing the filing of two pesticide petitions: PP
9E7570 by Interregional Research Project Number 4 (IR-4), 500 College
Rd. East, Suite 201 W, Princeton, NJ 08540; and PP 9F7571 by ISK
Biosciences Corporation, 7470 Auburn Rd., Suite A, Concord, OH 44077.
PP 9E7570 requested that 40 CFR 180.574 be amended by establishing
tolerances for residues of the fungicide fluazinam, (3-chloro-N-[3-
chloro-2,6-dinitro-4-(trifluoromethyl)phenyl]-5-(trifluoromethyl)-2-
pyridinamine), in or on carrot, root at 0.8 parts per million (ppm). PP
9F7571 requested that 40 CFR 180.574 be amended by establishing
tolerances for residues of the fungicide fluazinam and the metabolite
AMGT, (3-[[4-amino-3-[[3-chloro-5-(trifloromethyl)-2-pyridinyl]amino]-
2-nitro-6-(trifluoromethyl) phenyl] thio]-2-(beta-D-glucopyranosyloxy)
propionic acid), in or on the raw agricultural commodity apple at 1.7
ppm and wet apple pomace at 5.0 ppm, and by establishing tolerances for
the combined residues of fluazinam and its metabolites, DAPA and AMPA,
in the following animal tissues and meat byproducts at 0.03 ppm:
Cattle, fat; cattle, kidney; cattle, liver; cattle, meat; cattle, meat
byproducts; goat, fat; goat, kidney; goat, liver; goat, meat; goat,
meat byproducts; horse, fat; horse, kidney; horse, liver; horse, meat;
horse, meat byproducts; milk; sheep, fat; sheep, kidney; sheep, liver;
sheep, meat; and sheep, meat byproducts. PP 9E7570 referenced a summary
of the petition prepared on behalf of IR-4 by ISK Biosciences, the
registrant; PP 9F7571 referenced a summary of the petition prepared by
the registrant, ISK Biosciences. Petition summaries are available in
the docket, https://www.regulations.gov. There were no comments received
in response to the notices of filing.
Based upon review of the data supporting the petition, EPA has
revised several proposed tolerances and has determined that several
other proposed tolerances are not necessary. 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 fluazinam including
exposure resulting from the tolerances established by this action.
EPA's assessment of exposures and risks associated with fluazinam
follows.
In the Federal Register of May 12, 2010 (75 FR 26662) (FRL-8824-5),
EPA published a Final Rule establishing tolerances for residues of the
fungicide fluazinam in or on bushberry subgroup 13-07B at 7.0 pm;
lettuce, head at 0.02 ppm; lettuce, leaf at 2.0 ppm; and onion, bulb,
subgroup 3-07A at 0.20 ppm,
[[Page 3028]]
associated with PP 8E7506. When the Agency conducted the risk
assessment in support of the May 12, 2010 tolerance action, it
considered the use of fluazinam in or on carrot, root (PP 9E7570),
apples and wet apple pomace (PP 9F7571), and fluazinam and its
metabolites AMPA and DAPA in the following animal tissues and meat
byproducts: Cattle, fat; cattle, kidney; cattle, liver; cattle, meat;
cattle, meat byproducts; goat, fat; goat, kidney; goat, liver; goat,
meat; goat, meat byproducts; horse, fat; horse, kidney; horse, liver;
horse, meat; horse, meat byproducts; milk; sheep, fat; sheep, kidney;
sheep, liver; sheep, meat; and sheep, meat byproducts (PP 9F7571).
However, because of data deficiencies identified during the course of
review, EPA was not able to recommend in favor of the tolerances
associated with PP 9E7570 and PP 9F7571. The deficiencies related to an
apple processing study, a cattle feeding study, and the analytical
method for the metabolites AMPA and DAPA in fat, liver, and kidney.
In response to the noted data deficiencies, the registrant provided
additional data for the apple processing study and a rebuttal to the
cattle feeding study; after further review, EPA has determined that
these studies are now acceptable. Additionally, in response to the
analytical method data deficiency, the registrant submitted a revised
analytical method and independent laboratory validation, which EPA has
concluded is adequate as an enforcement method for residues of
fluazinam, AMPA, and DAPA and their sulfamate conjugates in kidney,
liver, and fat. Detailed considerations regarding EPA's resolution of
these data deficiencies are discussed in the document, ``Fluazinam,
Petitions for the Establishment of Tolerances and Registration of New
Uses on Apples and Carrots. HED's Conclusions Regarding Registrant's
Response to Data Deficiencies'' which is available at https://regulations.gov in docket EPA-HQ-OPP-2009-0032.
Since EPA considered the additional uses proposed by PP 9E7570 and
PP 9F7571 in its most recent risk assessments, establishing tolerances
on these commodities will not change the estimated aggregate risks
resulting from use of fluazinam, as discussed in the May 12, 2010 (75
FR 26662) (FRL-8824-5) Federal Register. Therefore, EPA concludes that
there is a reasonable certainty that no harm will result to the general
population, and to infants and children from aggregate exposure to
fluazinam residues. Refer to the May 12, 2010 Federal Register
document, available at https://www.regulations.gov, for a detailed
discussion of the aggregate risk assessments and determination of
safety. EPA relies upon those risk assessments and the findings made in
the Federal Register document in support of this action.
IV. Other Considerations
A. Analytical Enforcement Methodology
An adequate enforcement methodology, gas chromatography with
electron capture detection (GC/ECD), is available to enforce the
tolerance expression for plant commodities. For livestock commodities,
an adequate enforcement method, liquid chromatography/mass
spectrometry/mass spectrometry (LC/MS/MS), is available to enforce the
tolerance expression for residues of fluazinam, AMPA, and DAPA and
their sulfamate conjugates in bovine liver, fat, and milk.
The methods may be requested from: Chief, Analytical Chemistry
Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD
20755-5350; telephone number: (410) 305-2905; e-mail address:
residuemethods@epa.gov.
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.
The Codex has not established MRLs for fluazinam in or on apple or
carrot. However, these tolerance petitions have been evaluated as a
joint review with Canada, and the United States and Canada have agreed
that the appropriate tolerance levels for carrot, roots is 0.70 ppm and
apple is 2.0 ppm.
C. Revisions to Petitioned-For Tolerances
Based on analysis of the data supporting the petitions, EPA has
revised the proposed tolerances in or on carrot, roots from 0.8 ppm to
0.70 ppm; apples from 1.7 ppm to 2.0 ppm; and the following proposed
tolerances from 0.03 ppm to 0.05 ppm: Cattle, fat; cattle, meat
byproducts; goat, fat; goat, meat byproducts; horse, fat; horse, meat
byproducts; sheep, fat; and sheep, meat byproducts. EPA revised these
tolerance levels based on analysis of the residue data using the
Agency's Tolerance Spreadsheet in accordance with the Agency's
``Guidance for Setting Pesticide Tolerances Based on Field Trial
Data.''
Additionally, based on the results of an animal feeding study and
the calculated dietary burden for dairy cattle, EPA has determined that
the proposed tolerances of 0.03 ppm for the meat of cattle, goat,
horse, and sheep are not necessary. The Agency has further determined
that the proposed tolerances of 0.03 ppm for the liver and kidney of
cattle, goat, horse, and sheep are not necessary because tolerances are
being established for meat byproducts of cattle, goat, horse, and
sheep; EPA previously determined that individual tolerances are not
needed for liver and kidney when a tolerance is being established for
meat byproducts.
V. Conclusion
Therefore, tolerances are established for residues of fluazinam,
(3-chloro-N-[3-chloro-2,6-dinitro-4-(trifluoromethyl)phenyl]-5-
(trifluoromethyl)-2-pyridinamine), in or on carrot, roots at 0.70 ppm;
apple at 2.0 ppm; apple, wet pomace at 5.0 ppm; and tolerances are
established for residues of fluazinam and its metabolites AMPA and DAPA
in or on cattle, fat at 0.05 ppm; cattle, meat byproducts at 0.05 ppm;
goat, fat at 0.05 ppm; goat, meat byproducts at 0.05 ppm; horse, fat at
0.05 ppm; horse, meat byproducts at 0.05 ppm; sheep, fat at 0.05 ppm;
and sheep, meat byproducts at 0.05 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
[[Page 3029]]
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) (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: January 7, 2011.
Daniel J. Rosenblatt,
Acting Director, Registration Division, 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 180.574 is amended by alphabetically adding the following
commodities to the table in paragraph (a)(1), and by adding paragraph
(a)(3) to read as follows:
Sec. 180.574 Fluazinam; tolerances for residues.
(a) General. (1) * * *
------------------------------------------------------------------------
Parts per
Commodity million
------------------------------------------------------------------------
Apple...................................................... 2.0
Apple, wet pomace.......................................... 5.0
* * * * *
Carrot, roots.............................................. 0.70
* * * * *
------------------------------------------------------------------------
* * * * *
(3) Tolerances are established for residues of fluazinam (3-chloro-
N-[3-chloro-2,6-dinitro-4-(trifluoromethyl)phenyl]-5-(trifluoromethyl)-
2-pyridinamine), including its metabolites and degradates, in or on the
commodities in the table below. Compliance with the tolerance levels
specified below is to be determined by measuring only fluazinam, AMPA
(2-(6-amino-3-chloro-[alpha],[alpha],[alpha]-trifluoro-2-nitro-p-
toluidino)-3-chloro-5-(trifluoromethyl) pyridine), DAPA (3-chloro-2-
(2,6-diamino-3-chloro-[alpha],[alpha],[alpha].-trifluoro-p-toluidino)-
5-(trifluoromethyl)pyridine), and their sulfamate conjugates.
------------------------------------------------------------------------
Parts per
Commodity million
------------------------------------------------------------------------
Cattle, fat................................................. 0.05
Cattle, meat byproducts..................................... 0.05
Goat, fat................................................... 0.05
Goat, meat byproducts....................................... 0.05
Horse, fat.................................................. 0.05
Horse, meat byproducts...................................... 0.05
Sheep, fat.................................................. 0.05
Sheep, meat byproducts...................................... 0.05
------------------------------------------------------------------------
* * * * *
[FR Doc. 2011-1019 Filed 1-18-11; 8:45 am]
BILLING CODE 6560-50-P
