[Federal Register Volume 76, Number 12 (Wednesday, January 19, 2011)]
[Rules and Regulations]
[Pages 3026-3029]
From the Federal Register Online via the Government Publishing 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 http://www.regulations.gov. Although listed in the index, some information is 
not publicly available, e.g., Confidential Business Information (CBI) 
or other information whose disclosure is restricted by statute. Certain 
other material, such as copyrighted material, is not placed on the 
Internet and will be publicly available only in hard copy form. 
Publicly available docket materials are available in the electronic 
docket at http://www.regulations.gov, or, if only available in hard 
copy, at the OPP Regulatory Public Docket in Rm. S-4400, One Potomac 
Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The Docket 
Facility is open from 8:30 a.m. to 4 p.m., Monday through Friday, 
excluding legal holidays. The Docket Facility telephone number is (703) 
305-5805.

FOR FURTHER INFORMATION CONTACT: Laura Nollen, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone 
number: (703) 305-7390; e-mail address: [email protected].

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 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-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: 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 (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, http://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 http://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 http://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: 
[email protected].

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

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[FR Doc. 2011-1019 Filed 1-18-11; 8:45 am]
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