[Federal Register Volume 70, Number 28 (Friday, February 11, 2005)]
[Rules and Regulations]
[Pages 7177-7182]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-2715]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-2005-0015; FRL-7696-8]


Thiamethoxam; Pesticide Tolerances 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 thiamethoxam and its metabolite, (CGA-322704) in 
or on artichoke, globe. 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 use of the pesticide 
on artichoke. This regulation establishes a maximum permissible level 
for residues of thiamethoxam and its metabolite, (CGA-322704) in this 
food commodity. The tolerance will expire and is revoked on June 30, 
2008.

DATES: This regulation is effective February 11, 2005. Objections and 
requests for hearings must be received on or before April 12, 2005.

ADDRESSES: To submit a written objection or hearing request follow the 
detailed instructions as provided in Unit VII. of the SUPPLEMENTARY 
INFORMATION. EPA has established a docket for this action under Docket 
identification (ID) number OPP-2005-0015. All documents in the docket 
are listed in the EDOCKET index at http://www.epa.gov/edocket. Although 
listed in the index, some information is not publicly available, i.e., 
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 either electronically 
in EDOCKET or in hard copy at the Public Information and Records 
Integrity Branch (PIRIB), Rm. 119, Crystal Mall 2, 1801 S. 
Bell St., Arlington, VA. This docket facility is open from 8:30 a.m. to 
4 p.m., Monday through Friday, excluding legal holidays. The docket 
telephone number is (703) 305-5805.

FOR FURTHER INFORMATION CONTACT: Barbara Madden, Registration Division 
(7505C), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone 
number: (703) 305-6463; 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. To determine 
whether you or your business may be affected by this action, you should 
carefully examine the applicability provisions discussed above. 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 and Other 
Related Information?

    In addition to using EDOCKET (http://www.epa.gov/edocket/), you may 
access this Federal Register document electronically through the EPA 
Internet under the ``Federal Register'' listings at http://www.epa.gov/
fedrgstr/. A frequently updated electronic version of 40 CFR part 180 
is available at E-CFR Beta Site Two at http://www.gpoaccess.gov/ecfr/.

II. Background and Statutory Findings

    EPA, on its own initiative, in accordance with sections 408(e) and 
408(l)(6) of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 
U.S.C. 346a, is establishing a tolerance for combined

[[Page 7178]]

residues of the insecticide thiamethoxam, 3-[(2-chloro-5-
thiazolyl)methyl]tetrahydro-5-methyl-N-nitro-4H-1,3,5-oxadiazin-4-imine 
and its metabolite CGA-322704 (N-(2-chloro-thiazol-5-ylmethyl)-N`-
methyl-N'`-nitro-guanidine), in or on artichoke, globe at 0.40 parts 
per million (ppm). This tolerance will expire and is revoked on June 
30, 2008. EPA will publish a document in the Federal Register to remove 
the revoked tolerance from the Code of Federal Regulations.
    Section 408(l)(6) of the 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 tolerances to set binding precedents for the 
application of section 408 of the FFDCA and the new safety standard to 
other tolerances and exemptions. Section 408(e) of the 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 the 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 the 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 the 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 the 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.'' This 
provision was not amended by the Food Quality Protection Act of 1996 
(FQPA). EPA has established regulations governing such emergency 
exemptions in 40 CFR part 166.

III. Emergency Exemption for Thiamethoxam on Artichokes and FFDCA 
Tolerances

    The proba bug is a native insect and it normally occurs on coyote 
brush and Baccharis pilularis. It was first reported to cause crop 
damage to artichokes in 1996 on a localized field of Mulligan Hill 
Ranch in Castorville, California. The saliva of the proba bug contains 
phyto-toxins that are the primary cause of plant injury. The injury 
results in death of leaf tissue. Further, affected stalks are weakened 
and cannot support bud development causing the bud to drop. 
Methidathion, which is registered for use on artichokes, is highly 
effective in controlling proba bug however, its use is restricted to 
use on the vegetative stage of artichoke. The State has included a 
restriction not allowing applications of thiamethoxam to the vegetative 
stage of the plant. Other insecticides registered for use on artichokes 
have proven ineffective in controlling this pest. EPA has authorized 
under FIFRA section 18 the use of thiamethoxam on artichoke for control 
of proba bug in California. After having reviewed the submission, EPA 
concurs that emergency conditions exist for this State.
    As part of its assessment of this emergency exemption, EPA assessed 
the potential risks presented by residues of thiamethoxam and its 
metabolite, (CGA-322704) in or on artichoke. In doing so, EPA 
considered the safety standard in section 408(b)(2) of the FFDCA, and 
EPA decided that the necessary tolerance under section 408(l)(6) of the 
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 
tolerance without notice and opportunity for public comment as provided 
in section 408(l)(6) of the FFDCA. Although this tolerance will expire 
and is revoked on June 30, 2008, under section 408(l)(5) of the FFDCA, 
residues of the pesticide not in excess of the amounts specified in the 
tolerance remaining in or on artichoke after that date will not be 
unlawful, provided the pesticide is applied in a manner that was lawful 
under FIFRA, and the residues do not exceed a level that was authorized 
by this tolerance at the time of that application. EPA will take action 
to revoke this 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 tolerance is being approved under emergency 
conditions, EPA has not made any decisions about whether thiamethoxam 
and its metabolite, (CGA-322704) meets EPA's registration requirements 
for use on artichoke or whether a permanent tolerance for this use 
would be appropriate. Under these circumstances, EPA does not believe 
that this tolerance serves as a basis for registration of thiamethoxam 
by a State for special local needs under FIFRA section 24(c). Nor does 
this tolerance serve as the basis for any State other than California 
to use this pesticide on this crop under section 18 of FIFRA without 
following all provisions of EPA's regulations implementing FIFRA 
section 18 as identified in 40 CFR part 166. For additional information 
regarding the emergency exemption for thiamethoxam, contact the 
Agency's Registration Division at the address provided under FOR 
FURTHER INFORMATION CONTACT.

IV. Aggregate Risk Assessment and Determination of Safety

    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 the FFDCA and a complete 
description of the risk assessment process, see the final rule on 
Bifenthrin Pesticide Tolerances (62 FR 62961, November 26, 1997) (FRL-
5754-7).
    Consistent with section 408(b)(2)(D) of the 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 
thiamethoxam and its metabolite, CGA-32270 and to make a determination 
on aggregate exposure, consistent with section 408(b)(2) of the FFDCA, 
for a time-limited tolerance for combined residues of thiamethoxam and 
its metabolite, (CGA-322704) in or on artichoke, globe at 0.40 ppm.
    On January 5, 2005 the Agency published in the Federal Register (70 
FR 708) (FRL-7689-7), a Final Rule establishing tolerances for combined 
residues of thiamethoxam and its metabolite in or on legume vegetables, 
root vegetables (except sugar beet), strawberries, bushberries, 
juneberries, lingonberries, salal, cranberries, spearmint, peppermint, 
rapeseed, mustard, flax, safflower, crambe, borage, and potatoes. When 
the Agency conducted risk assessments to determine the potential human 
health risks from use of thiamethoxam and its

[[Page 7179]]

metabolite to support the tolerances on legume vegetables, root 
vegetables (except sugar beet), strawberries, bushberries, juneberries, 
lingonberries, salal, cranberries, spearmint, peppermint, rapeseed, 
mustard, flax, safflower, crambe, borage, and potatoes (PP  
2E6363, 3E6781, 3E6800, 3E6805, 3E6806, 3E6807, 4E6819), these risk 
assessments also assessed the use of thiamethoxam on artichokes under 
section 18 of FIFRA. Therefore, establishing the artichoke tolerance 
will not change the most recent estimated aggregate risks resulting 
from use of thiamethoxam, as discussed in the January 5, 2005 Federal 
Register (70 FR 708). Refer to the January 5, 2005 Federal Register (70 
FR 708) document 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. Below is a brief summary of the aggregate risk 
assessments.
    Acute dietary risk assessments are performed for a food-use 
pesticide, if a toxicological study has indicated the possibility of an 
effect of concern occurring as a result of a 1-day or single exposure.
    In conducting the acute dietary risk assessment EPA used the 
Dietary Exposure Evaluation Model software with the Food Commodity 
Intake Database (DEEM-FCID\T\), which incorporates food consumption 
data as reported by respondents in the United States Department of 
Agriculture (USDA) 1994-1996 and 1998 Nationwide Continuing Surveys of 
Food Intake by Individuals (CSFII), and accumulated exposure to the 
chemical for each commodity. For the acute exposure assessments the 
residues of concern are thiamethoxam and its metabolite (CGA-322704) 
also know as clothianidin. The assessment for thiamethoxam assumed that 
100% of the registered and proposed crops were treated and that all 
treated crops and livestock had residues of concern at the tolerance 
level. The general U.S. population and all population subgroups have 
exposure and risk estimates which are below the Agency's level of 
concern (i.e., the aPADs are all below 100%). The most highly exposed 
subgroup is children 1 to 2 years of age. The exposure estimate for 
children 1 to 2 years of age is 0.01099 milligram/kilogram (mg/kg)/day, 
which is equivalent to 11% of the aPAD. In addition, there is potential 
for acute dietary exposure to thiamethoxam in drinking water. After 
calculating drinking water levels of comparison (DWLOCs) and comparing 
them to the estimated environmental concentrations (EECs) for surface 
water and ground water, EPA does not expect the aggregate exposure to 
exceed 100% of the aPAD, as shown in Table 1 of this unit:

                     Table 1.--Aggregate Risk Assessment for Acute Exposure to Thiamethoxam
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                                                                             Surface       Ground
              Population Subgroup                 aPAD (mg/     % aPAD/     Water EEC/   Water EEC/  Acute DWLOC/
                                                     kg)         (Food)       (ppb)        (ppb)        (ppb)
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General U.S. population                                  0.1            4         11.4            5         3400
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All infants < 1 year old                                 0.1           10         11.4            5          900
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Children 1-2 years old                                   0.1           11         11.4            5          890
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Females 13-49 years old                                  0.1            2         11.4            5         2900
----------------------------------------------------------------------------------------------------------------

    In conducting the chronic dietary risk assessment EPA used DEEM-
FCID\TM\, which incorporates food consumption data as reported by 
respondents in the USDA 1994-1996 and 1998 Nationwide Continuing 
Surveys of Food Intake by Individuals (CSFII), and accumulated exposure 
to the chemical for each commodity. For the chronic exposure 
assessments the residues of concern are thiamethoxam and its metabolite 
clothianidin. The chronic analysis for thiamethoxam was based on 
anticipated residues in the form of average field trial residue values, 
and the analysis included percent crop estimates. The general U.S. 
population and all population subgroups have exposure and risk 
estimates which are below the Agency's level of concern (i.e., the 
cPADs are all below 100%). The most highly exposed subgroup is children 
1 to 2 years of age. The exposure estimate for children 1 to 2 years of 
age is 0.000103 mg/kg/day, which is equivalent to 17% of the cPAD. 
There are no residential uses for thiamethoxam that result in chronic 
residential exposure. In addition, there is potential for chronic 
dietary exposure to thiamethoxam in drinking water. After calculating 
DWLOCs and comparing them to the EECs for surface water and ground 
water, EPA does not expect the aggregate exposure to exceed 100% of the 
cPAD, as shown in Table 2 of this unit:

              Table 2.--Aggregate Risk Assessment for Chronic (Non-Cancer) Exposure to Thiamethoxam
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                                                                             Surface      Ground/
              Population/Subgroup                cPAD/mg/kg/    %/cPAD/     Water EEC/   Water EEC/    Chronic/
                                                     day         (Food)       (ppb)        (ppb)     DWLOC (ppb)
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U.S. Population                                       0.0006            6         0.77         1.94           20
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All infants < 1 year old                              0.0006           11         0.77         1.94          5.4
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Children 1-2 years old                                0.0006           17         0.77         1.94            5
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Females 13-49 years old                               0.0006            5         0.77         1.94           17
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[[Page 7180]]

    Short-term and intermediate-term aggregate exposure takes into 
account residential exposure plus chronic exposure to food and water 
(considered to be a background exposure level). Thiamethoxam is not 
registered for use on any sites that would result in residential 
exposure. Therefore, the aggregate risk is the sum of the risk from 
food and water, which do not exceed the Agency's level of concern.
    Thiamethoxam has been classified as a likely carcinogen for humans 
based on increased incidence of hepatocellular adenomas and carcinomas 
in male and female mice. Quantification of risk based on most potent 
unit risk: Male mouse liver adenoma and/or carcinoma combined tumor 
rate. The upper bound estimate of unit risk, Q1* (mg/kg/
day)-\1\ is 3.77 x 10-\2\ in human equivalents. 
The residue of concern for the cancer analysis is thiamethoxam, per se. 
The residues of its metabolite clothianidin were removed from the 
cancer analysis because the metabolite was found to be ``not likely to 
be carcinogenic to humans'' when it was evaluated as an active 
ingredient. The cancer analysis was based on average field trial 
residue values as well as percent crop treated estimates. The estimated 
dietary exposure to the U.S. population is 0.000263 mg/kg/day. In 
conducting the aggregate cancer risk assessment, only dietary and 
drinking water pathways of exposure were considered. At this time, 
there are no uses for thiamethoxam that would result in any non-
occupational, non-dietary exposure (i.e., there are no dermal or 
inhalation routes of exposure that should be included in an aggregate 
assessment). A DWLOC was derived for the general U.S. population based 
on EPA's level of concern for cancer or a risk in the range of 1 in 1 
million. The DWLOC is compared to the estimated environmental 
concentrations of thiamethoxam in surface water and ground water and is 
used to determine whether or not aggregate cancer exposures are likely 
to result in risk estimates that exceed EPA's level of concern. Table 3 
of this unit summarizes the drinking water estimated concentrations of 
thiamethoxam in surface water and ground water and the associated DWLOC 
for cancer:

                     Table 3.--Aggregate Risk Assessment for Cancer Exposure to Thiamethoxam
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                                                                Maximum/
                                      Maximum/      Food/        Water/      Cancer/      Ground/      Surface/
        Population/Subgroup         Exposure/mg/ Exposure/mg/ Exposure/mg/  DWLOC/ppb    Water/EEC/   Water/EEC/
                                       kg/day       kg/day       kg/day                     ppb          ppb
----------------------------------------------------------------------------------------------------------------
General U.S. population              7.96 x 10-   7.96 x 10-   7.96 x 10-         1.87         1.94         0.31
                                            \5\          \5\          \5\
----------------------------------------------------------------------------------------------------------------

    For cancer, the DWLOC is slightly less than the ground water EEC. 
However, the cancer DWLOC is based on a conservative estimate of 
dietary exposure. Available information from actual prospective ground 
water monitoring data demonstrates that actual thiamethoxam residues in 
groundwater occur at or below 0.05 ppb. This interim analysis suggests 
that actual long-term residues of thiamethoxam in ground water will be 
significantly less than the levels predicted by the screening 
concentration in ground water (SCIGROW) model. A significant decrease 
in the level of thiamethoxam in drinking water results in an aggregate 
risk estimate that is unlikely to exceed EPA's level of concern for 
cancer. Further, the DWLOC numerical computation was done using a 
cancer risk figure of 1 in 1 million although EPA has repeatedly found 
that risk figures marginally higher than 1 in 1 million fall within the 
range of a 1 in 1 million risk.
    6. Determination of safety. Based on these risk assessments, EPA 
concludes that there is a reasonable certainty that no harm will result 
to the general population, and to infants and children from aggregate 
exposure to thiamethoxam residues.

V. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology (aqueous acetonitrile solvent 
extraction, liquid-liquid partitioning and solid-phase extraction 
cleanup, and high pressure liquid concentration/ultraviolet (HPLC/UV) 
analysis) is available to enforce the tolerance expression. The method 
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 international residue limits for thiamethoxam.

VI. Conclusion

    Therefore, the tolerance is established for combined residues of 
thiamethoxam, 3-[(2-chloro-5-thiazolyl)methyl]tetrahydro-5-methyl-N-
nitro-4H-1,3,5-oxadiazin-4-imine and its metabolite (N-(2-chloro-
thiazol-5-ylmethyl)-N`-methyl-N'`-nitro-guanidine), in or on artichoke, 
globe at 0.40 ppm.

VII. Objections and Hearing Requests

    Under section 408(g) of the FFDCA, as amended by the 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. Although the procedures in those 
regulations require some modification to reflect the amendments made to 
the FFDCA by the FQPA, EPA will continue to use those procedures, with 
appropriate adjustments, until the necessary modifications can be made. 
The new section 408(g) of the FFDCA provides essentially the same 
process for persons to ``object'' to a regulation for an exemption from 
the requirement of a tolerance issued by EPA under new section 408(d) 
of the FFDCA, as was provided in the old sections 408 and 409 of the 
FFDCA. However, the period for filing objections is now 60 days, rather 
than 30 days.

A. What Do I Need to Do to File an Objection or Request a Hearing?

    You must file your objection or request a hearing on this 
regulation in accordance with the instructions provided in this unit 
and in 40 CFR part 178. To ensure proper receipt by EPA, you must 
identify docket ID number OPP-2005-0015 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 April 12, 
2005.
    1. Filing the request. Your objection must specify the specific 
provisions in the regulation that you object to, and the grounds for 
the objections (40 CFR

[[Page 7181]]

178.25). If a hearing is requested, the objections must include a 
statement of the factual issues(s) on which a hearing is requested, the 
requestor's contentions on such issues, and a summary of any evidence 
relied upon by the objector (40 CFR 178.27). Information submitted in 
connection with an objection or hearing request may be claimed 
confidential by marking any part or all of that information as CBI. 
Information so marked will not be disclosed except in accordance with 
procedures set forth in 40 CFR part 2. A copy of the information that 
does not contain CBI must be submitted for inclusion in the public 
record. Information not marked confidential may be disclosed publicly 
by EPA without prior notice.
    Mail your written request to: Office of the Hearing Clerk (1900L), 
Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460-0001. You may also deliver your request to the 
Office of the Hearing Clerk in Suite 350, 1099 14th St., NW., 
Washington, DC 20005. The Office of the Hearing Clerk is open from 8 
a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The 
telephone number for the Office of the Hearing Clerk is (202) 564-6255.
    2. Copies for the Docket. In addition to filing an objection or 
hearing request with the Hearing Clerk as described in Unit VII.A., you 
should also send a copy of your request to the PIRIB for its inclusion 
in the official record that is described inADDRESSES. Mail your copies, 
identified by the docket ID number OPP-2005-0015, to: Public 
Information and Records Integrity Branch, Information Resources and 
Services Division (7502C), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001. In person or by courier, bring a copy to the location of the 
PIRIB described in ADDRESSES. You may also send an electronic copy of 
your request via e-mail to: [email protected]. Please use an ASCII 
file format and avoid the use of special characters and any form of 
encryption. Copies of electronic objections and hearing requests will 
also be accepted on disks in WordPerfect 6.1/8.0 or ASCII file format. 
Do not include any CBI in your electronic copy. You may also submit an 
electronic copy of your request at many Federal Depository Libraries.

B. When Will the Agency Grant a Request for a Hearing?

    A request for a hearing will be granted if the Administrator 
determines that the material submitted shows the following: There is a 
genuine and substantial issue of fact; there is a reasonable 
possibility that available evidence identified by the requestor would, 
if established resolve one or more of such issues in favor of the 
requestor, taking into account uncontested claims or facts to the 
contrary; and resolution of the factual issues(s) in the manner sought 
by the requestor would be adequate to justify the action requested (40 
CFR 178.32).

VIII. Statutory and Executive Order Reviews

    This final rule establishes a time-limited tolerance under section 
408 of the FFDCA. 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 due to its lack of significance, 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). 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., or 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). 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); 
or OMB review or any Agency action under Executive Order 13045, 
entitled Protection of Children from Environmental Health Risks and 
Safety Risks (62 FR 19885, April 23, 1997). 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). Since 
tolerances and exemptions that are established on the basis of a FIFRA 
section 18 exemption under section 408 of the 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. In addition, the Agency has 
determined that this action will not have a substantial direct effect 
on States, on the relationship between the national government and the 
States, or on the distribution of power and responsibilities among the 
various levels of government, as specified in Executive Order 13132, 
entitled Federalism (64 FR 43255, August 10, 1999). Executive Order 
13132 requires EPA to develop an accountable process to ensure 
``meaningful and timely input by State and local officials in the 
development of regulatory policies that have federalism implications.'' 
``Policies that have federalism implications'' is defined in the 
Executive order to include regulations that have ``substantial direct 
effects on the States, on the relationship between the national 
government and the States, or on the distribution of power and 
responsibilities among the various levels of government.'' This final 
rule directly regulates growers, food processors, food handlers, and 
food retailers, not States. This action does not alter the 
relationships or distribution of power and responsibilities established 
by Congress in the preemption provisions of section 408(n)(4) of the 
FFDCA. For these same reasons, the Agency has determined that this rule 
does not have any ``tribal implications'' as described in Executive 
Order 13175, entitled Consultation and Coordination with Indian Tribal 
Governments (65 FR 67249, November 6, 2000). Executive Order 13175, 
requires EPA to develop an accountable process to ensure ``meaningful 
and timely input by tribal officials in the development of regulatory 
policies that have tribal implications.'' ``Policies that have tribal 
implications'' is defined in the Executive order to include regulations 
that have ``substantial direct effects on one or more Indian tribes, on 
the relationship between the Federal Government and the Indian tribes, 
or on the distribution of power and responsibilities between the 
Federal Government and Indian tribes.'' This rule will not have 
substantial direct effects on tribal governments, on the relationship 
between the Federal Government and Indian tribes, or on the 
distribution of power and responsibilities between the Federal 
Government and Indian tribes, as specified in Executive Order 13175. 
Thus, Executive Order 13175 does not apply to this rule.

IX. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the 
Small Business Regulatory Enforcement Fairness Act of 1996, generally 
provides that before a rule may take effect, the agency promulgating 
the rule must submit a rule report, which includes a copy of the rule, 
to each House of the

[[Page 7182]]

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 30, 2005.
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 180.565 is amended by alphabetically adding the commodity 
``Artichoke'' to the table in paragraph (b) to read as follows:


Sec.  180.565   Thiamethoxam; tolerances for residues.

* * * * *
    (b) * * *

------------------------------------------------------------------------
                                                          Expiration/
             Commodity              Parts per million   revocation date
------------------------------------------------------------------------
Artichoke, globe..................               0.40            6/30/08
                               * * * * * *
------------------------------------------------------------------------

* * * * *

[FR Doc. 05-2715 Filed 2-10-05; 8:45 am]
BILLING CODE 6560-50-S