[Federal Register Volume 73, Number 79 (Wednesday, April 23, 2008)]
[Rules and Regulations]
[Pages 21839-21843]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-8675]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2008-0003; FRL-8359-7]


Pyraclostrobin; Pesticide Tolerance for Emergency Exemptions

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes a time-limited tolerance 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) pyrazol-3-yl]oxy]o-tolyl]carbamate), expressed as parent 
compound, in or on Belgian endive. This action is in response to EPA's 
granting of an emergency exemption under section 18 of the Federal 
Insecticide, Fungicide, and Rodenticide Act (FIFRA) authorizing post 
harvest use of the pesticide on endive, Belgian to control the fungal 
pathogen, Sclerotinia sclerotiorum. This regulation establishes a 
maximum permissible level for residues of pyraclostrobin in this food 
commodity. The time-limited tolerance expires and is revoked on 
December 31, 2009.

DATES: This regulation is effective April 23, 2008. Objections and 
requests for hearings must be received on or before June 23, 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-2008-0003. 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

[[Page 21840]]

available either in the electronic docket at http://www.regulations.gov, or, if only available in hard copy, at the Office 
of Pesticide Programs (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: Stacey Groce, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone 
number: (703) 305-2505; 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:
     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 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 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 the Federal Food, Drug, and Cosmetic Act 
(FFDCA), as amended by the Food Quality Protection Act of 1996 (FQPA), 
any person may file an objection to any aspect of this regulation and 
may also request a hearing on those objections. The EPA procedural 
regulations which govern the submission of objections and requests for 
hearings appear in 40 CFR part 178. 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-2008-0003 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 on or 
before June 23, 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 your copies, identified by docket ID 
number EPA-HQ-OPP-2008-0003, 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. Background and Statutory Findings

    EPA, on its own initiative, in accordance with sections 408(e) and 
408(l)(6) of FFDCA, 21 U.S.C. 346a(e) and 346a(1)(6), is establishing a 
time-limited tolerance for combined residues of the fungicide, 
pyraclostrobin, in or on endive, Belgian at 11.0 parts per million 
(ppm). This time-limited tolerance expires and is revoked on December 
31, 2009. EPA will publish a document in the Federal Register to remove 
the revoked tolerance from the CFR.
    Section 408(l)(6) of FFDCA requires EPA to establish a time-limited 
tolerance or exemption from the requirement for a tolerance for 
pesticide chemical residues in food that will result from the use of a 
pesticide under an emergency exemption granted by EPA under section 18 
of FIFRA. Such tolerances can be established without providing notice 
or period for public comment. EPA does not intend for its actions on 
section 18 related time-limited tolerances to set binding precedents 
for the application of section 408 of FFDCA and the new safety standard 
to other tolerances and exemptions. Section 408(e) of FFDCA allows EPA 
to establish a tolerance or an exemption from the requirement of a 
tolerance on its own initiative, i.e., without having received any 
petition from an outside party.
    Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a time-
limited 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. . . 
.''
    Section 18 of FIFRA authorizes EPA to exempt any Federal or State 
agency from any provision of FIFRA, if EPA determines that ``emergency 
conditions exist which require such exemption.'' EPA has established 
regulations governing such emergency exemptions in 40 CFR part 166.

III. Emergency Exemption for Pyraclostrobin on Endive, Belgian and 
FFDCA Tolerances

    The California Environmental Protection Agency, Department of 
Pesticide Regulation, utilized the crisis

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provision under section 18 of FIFRA for emergency use of pyraclostrobin 
as a post harvest treatment on chicory roots to control fungal growth 
of Sclerotinia sclerotiorum during cold storage. According to the 
applicant, portions of the dormant roots are periodically removed from 
cold storage and propagated in sheds within a controlled environment in 
order to stimulate bud development. These edible buds are known as 
Belgian endives, and are marketed. Based on information provided in the 
submission, an emergency situation exists because the pathogen, 
Sclerotinia sclerotiorum, resides in field soils and can grow on the 
chicory root during cold storage, which makes the produce unmarketable. 
The state's application asserts there are currently no other fungicides 
registered for the post harvest treatment of chicory root to control 
fungal growth. Further, the State claims that good agricultural 
practices are not sufficient to suppress this fungal pathogen. EPA has 
authorized a crisis exemption for the California Department of 
Pesticide Regulation under FIFRA section 18 for the use of 
pyraclostrobin on endive, Belgian for control of Sclerotinia 
sclerotiorum. The crisis exemption program ended on January 31, 2008.
    As part of its evaluation of the emergency exemption application, 
EPA assessed the potential risks presented by residues of 
pyraclostrobin in or on endive, Belgian. In doing so, EPA considered 
the safety standard in section 408(b)(2) of FFDCA, and EPA decided that 
the necessary time-limited tolerance under section 408(l)(6) of FFDCA 
would be consistent with the safety standard and with FIFRA section 18. 
Consistent with the need to move quickly on the emergency exemption in 
order to address an urgent non-routine situation and to ensure that the 
resulting food is safe and lawful, EPA is issuing this time-limited 
tolerance without notice and opportunity for public comment as provided 
in section 408(l)(6) of FFDCA. Although this time-limited tolerance 
expires and is revoked on December 31, 2009, under section 408(l)(5) of 
FFDCA, residues of the pesticide not in excess of the amounts specified 
in the tolerance remaining in or on endive, Belgian after that date 
will not be unlawful, provided the pesticide was applied in a manner 
that was lawful under FIFRA, and the residues do not exceed a level 
that was authorized by these time-limited tolerances at the time of 
that application. EPA will take action to revoke this time-limited 
tolerance earlier if any experience with, scientific data on, or other 
relevant information on this pesticide indicate that the residues are 
not safe.
    Because this time-limited tolerance is being approved under 
emergency conditions, EPA has not made any final decisions about 
whether pyraclostrobin meets FIFRA's registration requirements for use 
on endive, Belgian or whether a permanent tolerance for this use would 
be appropriate. Under these circumstances, EPA does not believe that 
this time-limited tolerance decision serves as a basis for registration 
of pyraclostrobin by a State for special local needs under FIFRA 
section 24(c). Nor does this time-limited tolerance serve as the basis 
for persons in any State other than California to use this pesticide on 
this crop under FIFRA section 18 absent the issuance of an emergency 
exemption applicable within that State. For additional information 
regarding the emergency exemption for pyraclostrobin, contact the 
Agency's Registration Division at the address provided under FOR 
FURTHER INFORMATION CONTACT.

IV. Aggregate Risk Assessment and Determination of Safety

    Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a time-
limited 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. . . 
.''
    EPA performs a number of analyses to determine the risks from 
aggregate exposure to pesticide residues. For further discussion of the 
regulatory requirements of section 408 of FFDCA and a complete 
description of the risk assessment process, see http:www.epa.gov/fedrgstr/EPA-PEST/1997/November/Day-26/p30948.htm.
    Consistent with 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 expected as a result of this emergency exemption request and 
the time-limited tolerance for combined residues of pyraclostrobin on 
endive, Belgian at 11.0 ppm. EPA's assessment of exposures and risks 
associated with establishing a time-limited tolerance follows.
    In the Federal Register of September 26, 2007 (72 FR 54564, FRL-
8148-6), EPA published a final rule establishing tolerances for the 
combined residues of pyraclostrobin and its desmethoxy metabolite in or 
on berry, group 13; cotton, undelinted seed; and cotton, gin 
byproducts. When the Agency conducted the risk assessments in support 
of the above referenced tolerance action, EPA also assessed data 
submitted in the California Department of Environmental Protection 
emergency exemption request from trials that used backpack sprayers in 
both pre-cold storage and pre-forcing trays. This assessment determined 
that the backpack sprayer trials reflected the worse-case scenario and 
that the Agency could support the section 18 request and grant a time-
limited tolerance of 11 ppm on Belgian endive.
    This time-limited tolerance is expected to adequately cover any 
pyraclostrobin residues using the backpack sprayer application method. 
The values for combined pyraclostrobin residues were used to calculate 
the appropriate tolerance for Belgian endive. A detailed summary of 
this evaluation can be found in the document dated May 30, 2007 
entitled, ``Pyraclostrobin. Amendment. Petition for Tolerance on 
Belgian endive. Additional Discussion of Residue Data and Its Use For 
Adjustment of Previous Tolerance Recommendation'' by going to http://www.regulations.gov. The referenced document is available in the docket 
established by this action, which is described under ADDRESSES, and is 
identified as EPA-HQ-OPP-2008-0003 in that docket. Locate and click on 
the hyperlink for docket ID number EPA-HQ-OPP-2008-0003. Double-click 
on the document to view the referenced information of page 2 of 8.
    Since EPA calculated a time-limited tolerance of 11.0 ppm for 
Belgian endive in the May 30, 2007 amendment, the establishment of this 
time-limited tolerance will not change the estimated aggregate risks 
resulting from use of pyraclostrobin as discussed in the final rule 
published in the Federal Register on September 26, 2007. Refer to this 
Federal Register document available at http://www.regulations.gov for a 
more

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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 as well as 
the amendment dated May 30, 2007 referenced in Unit. IV. Refer to 
docket ID number EPA-HQ-OPP-2008-0003 at http://www.regulations.gov for 
a detailed review of this document.
    Based on the risk assessments discussed in the final rule published 
in the Federal Register on September 26, 2007, (72 FR 54564, FRL-8148-
6), and the document ``Pyraclostrobin. Amendment. Petition for 
Tolerance on Belgian endive. Additional Discussion of Residue Data and 
Its Use For Adjustment of Previous Tolerance Recommendation,'' EPA 
concludes that there is reasonable certainty that no harm will result 
to the general population and to infants and children from aggregate 
exposure to the combined residues of pyraclostrobin.

V. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology (a liquid chromatography/mass 
spectrometry (LC/MS/MS) method (BASF Method D9808), and a high 
performance liquid chromatography/ultraviolet (HPLC/UV) method (BASF 
Method D9904)) is 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

    There are no established or proposed Codex Maximum Residue Limits 
(MRLs) for pyraclostrobin. There are no Canadian or Mexican MRLs 
established for Belgian endive.

VI. Conclusion

    Therefore, a time-limited tolerance is 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) pyrazol-3-
yl]oxy]o-tolyl]carbamate), expressed as parent compound, in or on 
endive, Belgian at 11.0 ppm. This tolerance expires and is revoked on 
December 31, 2009.

VII. Statutory and Executive Order Reviews

    This final rule establishes tolerances under sections 408(e) and 
408(l)(6) 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 rule 
has been exempted from review under Executive Order 12866, this 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 in accordance 
with sections 408(e) and 408(l)(6) of FFDCA, such as the tolerances 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 rule. In addition, this 
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).

VIII. 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: April 7, 2008.
Donald R. Stubbs,
Acting 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 alphabetically adding text to 
paragraph (b) after the paragraph heading to read as follows:


Sec.  180.582  Pyraclostrobin; tolerances for residues.

* * * * *
    (b)* * * A time-limited tolerance is established 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) 
pyrazol-3-yl]oxy]o-tolyl]carbamate) in connection with use of the 
pesticide under section 18 emergency exemptions granted by EPA. The 
time-limited tolerance will expire and is revoked on the date specified 
in the following table.

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                                                                                          Expiration/revocation
                           Commodity                               Parts per million               date
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Endive, Belgian...............................................                     11.0                 12/31/09
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[FR Doc. E8-8675 Filed 4-22-08; 8:45 am]
BILLING CODE 6560-50-S