[Federal Register Volume 73, Number 147 (Wednesday, July 30, 2008)]
[Rules and Regulations]
[Pages 44164-44168]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-17480]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2007-0214; FRL-8373-2]


Pyraclostrobin; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for combined residues 
of pyraclostrobin and its desmethoxy metabolite in or on the following 
commodities: Borage, seed; castor oil plant, seed; chinese tallowtree, 
seed; crambe, seed; cuphea, seed; echium, seed; euphorbia, seed; 
evening primrose, seed; flax, seed; gold of pleasure, seed; hare's ear 
mustard, seed; jojoba, seed; lesquerella, seed; lunaria, seed; 
meadowfoam, seed; milkweed, seed; mustard, seed; niger seed, seed; oil 
radish, seed; poppy, seed; rapeseed, seed; rose hip, seed; safflower, 
seed; sesame, seed; stokes aster, seed; sweet rocket, seed; tallowwood, 
seed; tea oil plant, seed; and vernonia, seed. It also increases the 
existing tolerance for residues of pyraclostrobin and its desmethoxy 
metabolite in or on sunflower. BASF Corporation requested these 
tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective July 30, 2008. Objections and 
requests for hearings must be received on or before September 29, 2008, 
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-2007-0214. To access the 
electronic docket, go to http://www.regulations.gov, select ``Advanced 
Search,'' then ``Docket Search.'' Insert the docket ID number where 
indicated and select the ``Submit'' button. Follow the instructions on 
the regulations.gov website to view the docket index or access 
available documents. All documents in the docket are listed in the 
docket index available in 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

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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: Tony Kish, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone 
number: (703) 308-9443; e-mail address: [email protected].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

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

B. How Can I Access Electronic Copies of this Document?

    In addition to accessing an electronic copy of this Federal 
Register document through the electronic docket at http://www.regulations.gov, you may access this Federal Register document 
electronically through the EPA Internet under the ``Federal Register'' 
listings at http://www.epa.gov/fedrgstr. You may also access a 
frequently updated electronic version of EPA's tolerance regulations at 
40 CFR part 180 through the Government Printing Office's pilot e-CFR 
site at http://www.gpoaccess.gov/ecfr.

C. Can I File an Objection or Hearing Request?

    Under section 408(g) of FFDCA, 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-2007-0214 in the subject line on the first page of 
your submission. All requests must be in writing, and must be mailed or 
delivered to the Hearing Clerk as required by 40 CFR part 178 on or 
before September 29, 2008.
    In addition to filing an objection or hearing request with the 
Hearing Clerk as described in 40 CFR part 178, please submit a copy of 
the filing that does not contain any CBI for inclusion in the public 
docket that is described in ADDRESSES. Information not marked 
confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA 
without prior notice. Submit this copy, identified by docket ID number 
EPA-HQ-OPP-2007-0214, 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 (703) 305-5805.

II. Petition for Tolerance

    In the Federal Register of June 13, 2008 (73 FR 33814) (FRL-8367-
3), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21 
U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP 
6F7105) by BASF Corporation, 26 Davis Dr., Research Triangle Park, NC 
27709. The petition requested that 40 CFR 180.582 be amended by 
establishing tolerances for combined residues of the fungicide 
pyraclostrobin; carbamic acid, [2-[[[1-(4-chlorophenyl)-1H-pyrazol-3-
yl]oxy]methyl]phenyl]methoxy-, methyl ester and its desmethoxy 
metabolite; (methyl-N-[[[1-(4-chlorophenyl)-1H-pyrazol-3-
yl]oxy]methyl]phenylcarbamate, expressed as parent compound, in or on 
borage; castor oil plant; chinese tallowtree; crambe; cuphea; echium; 
euphorbia; evening primrose; flax seed; gold of pleasure; hare's ear 
mustard; jojoba; lesquerella; lunaria; meadowfoam; milkweed; mustard 
seed; niger seed; oil radish; poppy seed; rapeseed; rose hip; 
safflower; sesame; stokes aster; sunflower; sweet rocket; tallowwood; 
tea oil plant; and vernonia; each at 0.45 parts per million (ppm). That 
notice referenced a summary of the petition prepared by BASF 
Corporation, the registrant, which is available to the public in the 
docket, http://www.regulations.gov. There were no comments received in 
response to the notice of filing.
    No changes were made to the proposed tolerance levels; however, EPA 
modified the proposed commodity terms slightly (e.g., changing 
``borage'' to ``borage, seed'', ``cuphea'' to ``cuphea, seed'', etc.) 
to conform to current nomenclature recommendations.

III. Aggregate Risk Assessment and Determination of Safety

    Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a 
tolerance (the legal limit for a pesticide chemical residue in or on a 
food) only if EPA determines that the tolerance is ``safe.'' Section 
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a 
reasonable certainty that no harm will result from aggregate exposure 
to the pesticide chemical residue, including all anticipated dietary 
exposures and all other exposures for which there is reliable 
information.'' This includes exposure through drinking water and in 
residential settings, but does not include occupational exposure. 
Section 408(b)(2)(C) of FFDCA requires EPA to give special 
consideration to exposure of infants and children to the pesticide 
chemical residue in establishing a tolerance and to ``ensure that there 
is a reasonable certainty that no harm will result to infants and 
children from aggregate exposure to the pesticide chemical residue. . . 
.''
    Consistent with section 408(b)(2)(D) of FFDCA, and the factors 
specified in section 408(b)(2)(D) of FFDCA, EPA has reviewed the 
available scientific data and other relevant information in support of 
this action. EPA has sufficient data to assess the hazards of and to 
make a determination on aggregate exposure for the petitioned-for

[[Page 44166]]

tolerances for combined residues of pyraclostrobin and its desmethoxy 
metabolite on borage, seed; castor oil plant, seed; chinese tallowtree, 
seed; crambe, seed; cuphea, seed; echium, seed; euphorbia, seed; 
evening primrose, seed; flax, seed; gold of pleasure, seed; hare's ear 
mustard, seed; jojoba, seed; lesquerella, seed; lunaria, seed; 
meadowfoam, seed; milkweed, seed; mustard, seed; niger seed, seed; oil 
radish, seed; poppy, seed; rapeseed, seed; rose hip, seed; safflower, 
seed; sesame, seed; stokes aster, seed; sunflower, seed; sweet rocket, 
seed; tallowwood, seed; tea oil plant, seed; and vernonia, seed; each 
at 0.45 ppm. EPA's assessment of exposures and risks associated with 
establishing tolerances follows.
    On March 24, 2008 the Agency published a Final Rule (73 FR 15425, 
FRL-8355-4) establishing tolerances for residues of pyraclostrobin and 
its desmethoxy metabolite in or on avocado at 0.6 ppm; barley, grain at 
1.4 ppm; canistel at 0.6 ppm; mango at 0.6 ppm; oat, grain at 1.2 ppm; 
oat, hay at 18 ppm; oat, straw at 15 ppm; papaya at 0.6 ppm; sapodilla 
at 0.6 ppm; sapote, black at 0.6 ppm; sapote, mamey at 0.6 ppm; and 
star apple at 0.6 ppm. When the Agency conducted the risk assessments 
in support of this tolerance action it assumed that pyraclostrobin 
residues would be present on all of the oilseed commodities requested 
in this petition as well as on all foods covered by the proposed and 
established tolerances. Residues on oilseeds were included because 
there was a pending petition for pyraclostrobin tolerances on oilseed 
commodities at the time. The decision to establish tolerances on 
oilseed commodities was deferred until now because the original notice 
of filing of this petition contained errors requiring revision and re-
publication in the Federal Register. Since the oilseed commodities were 
included in the previous risk assessments, establishing the oilseed 
commodity tolerances will not change the most recent estimated 
aggregate risks resulting from use of pyraclostrobin, as discussed in 
the March 24, 2008 Federal Register. Refer to the March 24, 2008 
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.
    Based on the risk assessments discussed in the final rule published 
in the Federal Register of March 24, 2008 (73 FR 15425, FRL-8355-4), 
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 pyraclostrobin residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methods (an Liquid chromatography/mass/
spectrometry (LC/MS/MS) method (BASF Method D9808), and an high 
performance liquid chromatography/ultraviolet (HPLC/UV) method (BASF 
Method D9904)) are available to enforce the tolerance expression. 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

    No CODEX, Canadian or Mexican maximum residue limits (MRLs) have 
been established for residues of pyraclostrobin on the oilseed 
commodities associated with this petition.

V. Conclusion

    Therefore, tolerances are established for combined residues of 
pyraclostrobin carbamic acid, [2-[[[1-(4-chlorophenyl)-1H-pyrazol-3-
yl]oxy]methyl]phenyl]methoxy-, methyl ester and its desmethoxy 
metabolite; methyl-N-[[[1-(4-chlorophenyl)-1H-pyrazol-3-
yl]oxy]methyl]phenylcarbamate, expressed as parent compound, in or on 
borage, seed; castor oil plant, seed; chinese tallowtree, seed; crambe, 
seed; cuphea, seed; echium, seed; euphorbia, seed; evening primrose, 
seed; flax, seed; gold of pleasure, seed; hare's ear mustard, seed; 
jojoba, seed; lesquerella, seed; lunaria, seed; meadowfoam, seed; 
milkweed, seed; mustard, seed; niger seed, seed; oil radish, seed; 
poppy, seed; rapeseed, seed; rose hip, seed; safflower, seed; sesame, 
seed; stokes aster, seed; sweet rocket, seed; tallowwood, seed; tea oil 
plant, seed; and vernonia, seed; each at 0.45 ppm. The existing 
tolerance for combined residues of pyraclostrobin and its desmethoxy 
metabolite on sunflower at 0.3 ppm is revised to read ``sunflower, 
seed'' at 0.45 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, 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

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(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: July 10, 2008.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.

0
Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

0
1. The authority citation for part 180 continues to read as follows:

    Authority: 21 U.S.C. 321(q), 346a and 371.

0
2. Section 180.582 is amended by revising the entry for sunflower to 
read sunflower, seed, and alphabetically adding the following 
commodities to the table in paragraph (a)(1) to read as follows:


Sec.  180.582  Pyraclostrobin; tolerances for residues.

    (a) General. (1) * * *

------------------------------------------------------------------------
              Commodity                        Parts per million
------------------------------------------------------------------------
                                * * * * *
Borage, seed........................                                0.45
                                * * * * *
Castor oil plant, seed..............                                0.45
Chinese tallowtree, seed............                                0.45
                                * * * * *
Crambe, seed........................                                0.45
Cuphea, seed........................                                0.45
Echium, seed........................                                0.45
Euphorbia, seed.....................                                0.45
Evening primrose, seed..............                                0.45
Flax, seed..........................                                0.45
                                * * * * *
Gold of pleasure, seed..............                                0.45
                                * * * * *
Hare's ear mustard, seed............                                0.45
                                * * * * *
Jojoba, seed........................                                0.45
Lesquerella, seed...................                                0.45
Lunaria, seed.......................                                0.45
                                * * * * *
Meadowfoam, seed....................                                0.45
Milkweed, seed......................                                0.45
Mustard, seed.......................                                0.45
Niger seed, seed....................                                0.45
                                * * * * *
Oil radish, seed....................                                0.45
                                * * * * *
Poppy, seed.........................                                0.45
                                * * * * *
Rapeseed, seed......................                                0.45
Rose hip, seed......................                                0.45
                                * * * * *
Safflower, seed.....................                                0.45
                                * * * * *
Sesame, seed........................                                0.45
                                * * * * *
Stokes aster, seed..................                                0.45
                                * * * * *
Sunflower, seed.....................                                0.45
Sweet rocket, seed..................                                0.45
Tallowwood, seed....................                                0.45
Tea oil plant, seed.................                                0.45
                                * * * * *
Vernonia, seed......................                                0.45
                                * * * * *
------------------------------------------------------------------------


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[FR Doc. E8-17480 Filed 7-29-08; 8:45 am]
BILLING CODE 6560-50-S