[Federal Register Volume 70, Number 182 (Wednesday, September 21, 2005)]
[Rules and Regulations]
[Pages 55277-55282]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-18828]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-2005-0074; FRL-7736-2]


Iprovalicarb; Pesticide Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes a tolerance for residues of 
Iprovalicarb in or on tomatoes. Bayer CropScience AG requested this 
tolerance under the Federal Food, Drug, and Cosmetic Act (FFDCA), as 
amended by the Food Quality Protection Act of 1996 (FQPA).

DATES: This regulation is effective September 21, 2005. Objections and 
requests for hearings must be received on or before November 21, 2005.

ADDRESSES: To submit a written objection or hearing request follow the 
detailed instructions as provided in Unit VI. of the SUPPLEMENTARY 
INFORMATION. EPA has established a docket for this action under Docket 
identification (ID) number OPP-2005-0074. All documents in the docket 
are listed in the EDOCKET index athttp://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: Mary L. Waller, Registration Division 
(7505C), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone 
number: (703) 308-9354; 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

[[Page 55278]]

affected entities may include, but are not limited to:
     Crop production (NAICS code 111), e.g., agricultural 
workers; greenhouse, nursery, and floriculture workers; farmers.
     Animal production (NAICS code 112), e.g., cattle ranchers 
and farmers, dairy cattle farmers, livestock farmers.
     Food manufacturing (NAICS code 311), e.g., agricultural 
workers; farmers; greenhouse, nursery, and floriculture workers; 
ranchers; pesticide applicators.
     Pesticide manufacturing (NAICS code 32532), e.g., 
agricultural workers; commercial applicators; farmers; greenhouse, 
nursery, and floriculture workers; residential users.
    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 underFOR 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

    In the Federal Register of April 8, 2005 (70 FR 18001) (FRL-7703-
8), 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 
3E6578) by Bayer CropScience AG, 2 T.W. Alexander Drive; Research 
Triangle Park, NC 27709. The petition requested that 40 CFR 180.581 be 
amended by establishing a tolerance for residues of the fungicide 
iprovalicarb, [1-methylethyl [(1S)-2-methyl-1-[[[1-(4-methylphenyl) 
ethyl] amino] carbonyl] propyl] carbamate], in or on tomatoes at 1.0 
parts per million (ppm). That notice included a summary of the petition 
prepared by Bayer CropScience AG, the registrant. Comments were 
received on the notice of filing. EPA's response to these comments is 
discussed in Unit IV.C. below.
    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. . . 
.''
    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, seehttp://www.epa.gov/pesticides/factsheets/riskassess.htm

III. Aggregate Risk Assessment and Determination of Safety

    Consistent with 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, consistent with section 
408(b)(2) of FFDCA, for a tolerance for residues of iprovalicarb on 
tomatoes at 1.0 ppm. EPA's assessment of exposures and risks associated 
with establishing the tolerance follows.

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered its 
validity, completeness, and reliability as well as the relationship of 
the results of the studies to human risk. EPA has also considered 
available information concerning the variability of the sensitivities 
of major identifiable subgroups of consumers, including infants and 
children. Specific information on the studies received and the nature 
of the toxic effects caused by iprovalicarb as well as the no observed 
adverse effect level (NOAEL) and the lowest observed adverse effect 
level (LOAEL) from the toxicity studies can be found at http://www.epa.gov/edocket.

B. Toxicological Endpoints

    For hazards that have a threshold below which there is no 
appreciable risk, the dose at which no adverse effects are observed 
(the NOAEL) from the toxicology study identified as appropriate for use 
in risk assessment is used to estimate the toxicological level of 
concern (LOC). However, the lowest dose at which adverse effects of 
concern are identified (the LOAEL) is sometimes used for risk 
assessment if no NOAEL was achieved in the toxicology study selected. 
An uncertainty factor (UF) is applied to reflect uncertainties inherent 
in the extrapolation from laboratory animal data to humans and in the 
variations in sensitivity among members of the human population as well 
as other unknowns.
    The linear default risk methodology (Q*) is the primary method 
currently used by the Agency to quantify non-threshold hazards such as 
cancer. The Q* approach which assumes that any amount of exposure will 
lead to some degree of cancer risk, estimates risk in terms of the 
probability of occurrence of additional cancer cases. More information 
can be found on the general principles that EPA uses in risk 
characterization at http://www.epa.gov/oppfead1/trac/science/.
    A summary of the toxicological endpoints for iprovalicarb used for 
human risk assessment is discussed in Unit III.B. of the final rule 
published in the Federal Register of August 22, 2002 (67 FR 54351) 
(FRL-7194-3).

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. A tolerance has been 
established (40 CFR 180.581) for the residues of iprovalicarb, in or on 
grapes. Risk assessments were conducted by EPA to assess dietary 
exposures from iprovalicarb in food as follows:
    i. Acute exposure. Quantitative acute dietary exposure and 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.
    No such effects were identified in the toxicological studies for 
iprovalicarb; therefore, a quantitative acute dietary exposure 
assessment is unnecessary.
    ii. Chronic exposure. In conducting the chronic dietary exposure 
assessment EPA used the Dietary Exposure Evaluation Model software with 
the Food Commodity Intake Database (DEEM-FCID\TM\), both of which 
incorporate food consumption data as

[[Page 55279]]

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. The following 
assumptions were made for the chronic exposure assessments: Assessments 
were based on tolerance-level residues in/on grape commodities, 
anticipated residue (AR) values for tomato commodities, DEEM default 
processing factors, and 100% crop treated (100% CT) assumptions. The AR 
used for tomatoes was 0.5 ppm, or half the proposed tolerance level of 
1.0 ppm for harmonization purposes.
    iii. Cancer. The cancer dietary exposure analysis was based on the 
same assumptions as the chronic dietary exposure analysis.
    iv. Anticipated residue and percent crop treated (PCT)information.
    Section 408(b)(2)(E) of the FFDCA authorizes EPA to use available 
data and information on the anticipated residue levels of pesticide 
residues in food and the actual levels of pesticide chemicals that have 
been measured in food. If EPA relies on such information, EPA must 
pursuant to section 408(f)(1) require that data be provided 5 years 
after the tolerance is established, modified, or left in effect, 
demonstrating that the levels in food are not above the levels 
anticipated. Following the initial data submission, EPA is authorized 
to require similar data on a time frame it deems appropriate. For the 
present action, EPA will issue such data call-ins for information 
relating to anticipated residues as are required by FFDCA section 
408(b)(2)(E) and authorized under FFDCA section 408(f)(1). Such Data 
Call-Ins will be required to be submitted no later than 5 years from 
the date of issuance of this tolerance.
    2. Dietary exposure from drinking water. There is no expectation 
that exposure to iprovalicarb residues would occur via drinking water. 
This action is for a tolerance on imported tomatoes only, and there are 
no registered uses of iprovalicarb in the United States.
    3. From non-dietary exposure. The term``residential exposure'' is 
used in this document to refer to non-occupational, non-dietary 
exposure (e.g., for lawn and garden pest control, indoor pest control, 
termiticides, and flea and tick control on pets). Iprovalicarb is not 
registered for use on any sites that would result in residential 
exposure.
    4. Cumulative effects from substances with a common mechanism of 
toxicity. Section 408(b)(2)(D)(v) of the FFDCA requires that, when 
considering whether to establish, modify, or revoke a tolerance, the 
Agency consider ``available information'' concerning the cumulative 
effects of a particular pesticide's residues and ``other substances 
that have a common mechanism of toxicity.''
    Although iprovalicarb is a carbamate compound, it is not a member 
of the class of insecticides known as the N-methyl carbamates for which 
the Agency is presently conducting a cumulative risk assessment. The 
common mechanism determination for the N-methyl carbamates was based on 
shared structural characteristics and their shared ability to cause 
neurotoxicity through the inhibition of acetylcholinesterase (AChE) by 
carbamylation of the serine hydroxyl group located in the active site 
of the enzyme. Iprovalicarb does not fit these characteristics and 
therefore should not be included in the N-methyl carbamate common 
mechanism group nor should it be included in the N-methyl carbamate 
cumulative risk assessment. The Agency has concluded that other 
subgroups of carbamates do not share a common mechanism of toxicity. 
For information regarding EPA's efforts to determine which chemicals 
have a common mechanism of toxicity and to evaluate the cumulative 
effects of such chemicals, see the policy statements released by EPA's 
Office of Pesticide Programs concerning common mechanism determinations 
and procedures for cumulating effects from substances found to have a 
common mechanism on EPA's website athttp://www.epa.gov/pesticides/cumulative/.

D. Safety Factor for Infants and Children

    1. In general. Section 408 of FFDCA provides that EPA shall apply 
an additional tenfold margin of safety for infants and children in the 
case of threshold effects to account for prenatal and postnatal 
toxicity and the completeness of the data base on toxicity and exposure 
unless EPA determines based on reliable data that a different margin of 
safety will be safe for infants and children. Margins of safety are 
incorporated into EPA risk assessments either directly through use of a 
margin of exposure analysis or through using uncertainty (safety) 
factors in calculating a dose level that poses no appreciable risk to 
humans. In applying this provision, EPA either retains the default 
value of 10X when reliable data do not support the choice of a 
different factor, or, if reliable data are available, EPA uses a 
different additional safety factor value based on the use of 
traditional uncertainty factors and/or special FQPA safety factors, as 
appropriate.
    2. Prenatal and postnatal sensitivity. There is no evidence for 
increased succeptability of fetuses to in utero exposure to 
iprovalicarb in either the rat developmental or rabbit developmental 
studies. There is qualitative evidence of susceptibility in the multi-
generation reproduction study in the rat. However, it was concluded 
that there is a low degree of concern (and no residual uncertainty) for 
the effects seen because:
    i. The increased susceptibility (decrease in pup survival) was seen 
only at the highest dose tested (2,074 milligram/kilogram/day (mg/kg/
day)) which is twice the limit dose.
    ii. The decrease in pup survival was seen only in 1-generation (F1, 
not replicated in F2).
    iii. There are clearly defined NOAELs/LOAELs for parental and 
offspring toxicity.
    iv. The effects seen in the offspring occurred at a much higher 
dose (192 mg/kg/day) than that used to establish the Chronic RfD (NOAEL 
of 2.62 mg/kg/day). Furthermore, the Agency concluded that a 
developmental neurotoxicity study is not required. No treatment-related 
toxicologically significant sign of neurotoxicity were observed in any 
available studies on iprovalicarb.
    3. Conclusion. There is a complete toxicity data base for 
iprovalicarb and exposure data are complete or are estimated based on 
data that reasonably accounts for potential exposures. Additionally the 
Agency concludes that there are reliable data that indicate there are 
no (residual) concerns for the prenatal and/or postnatal toxicity 
following exposure to iprovalicarb. Therefore, no additional safety 
factor (1X) is necessary to protect the safety of infants and children.

E. Aggregate Risks and Determination of Safety

    1. Acute risk. An endpoint attributable to a single dose was not 
identified for any population subgroups. Therefore, no acute risk is 
expected.
    2. Chronic risk. Using the exposure assumptions described in this 
unit for chronic exposure, EPA has concluded that exposure to 
iprovalicarb from food will utilize 8.4% of the cPAD for the U.S. 
population, [9.9 %] of the cPAD for all infants (< 1 year), and 37% of 
the cPAD for children (1-2 years). There are no residential uses for 
iprovalicarb that result in chronic residential exposure to 
iprovalicarb. In addition, there is no potential for chronic dietary 
exposure to iprovalicarb in drinking water. EPA does not expect the 
aggregate exposure (dietary only) to exceed 100% of the cPAD, as shown 
in Table of this unit:

[[Page 55280]]



              Table 1.--Aggregate Risk Assessment for Chronic (Non-Cancer) Exposure to Iprovalicarb
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                 Population/Subgroup                        cPAD (mg/kg/day)                % cPAD (Food)
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U.S. population                                                              0.026                           8.4
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All Infants (< 1 yr)                                                         0.026                           9.9
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Children 1-2 yrs                                                             0.026                            37
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    3. Short-term risk. Iprovalicarb 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.
    4. Intermediate-term risk. Iprovalicarb 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.
    5. Aggregate cancer risk for U.S. population. The lifetime cancer 
risk from iprovalicarb dietary exposure is determined for the U.S. 
population (total) only. The estimated exposure to iprovalicarb is 
0.002189 mg/kg/day. Applying the Q1* of 4.47 x 10-\4\ (mg/kg/day)-\1\ 
to the exposure value results in a cancer risk estimate of 9.74 x 10-
\7\. This risk is negligible, and does not exceed the Agency's level of 
concern.
    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 iprovalicarb residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology (HLPC/MS) 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

    Iprovalicarb is not in the Codex system. There are no MRLs in 
Mexico. The Agency is recommending a 1.0 ppm tolerance on tomatoes in 
order to harmonize with the existing 1.0 mg/kg provisional maximum 
residue limit (MRL) for iprovalicarb on tomatoes in the European Union.

C. Response to Comments

    Comments were received from a private citizen on April 17, 2005 
objecting to the sale and use of this product. The comments further 
stated that no long term or combined tests have been done to show 
complete safety. The Agency response is as follows: The petitioner did 
not request registration of iprovalicarb in the U.S. The petitioner is 
seeking an import tolerance which would allow tomatoes treated in 
foreign countries to be imported into the U.S. The U.S. cannot regulate 
the sale and the use of a pesticide in a foreign country. The Agency 
had sufficient data, including chronic, long-term data, to support a 
determination that there is reasonable certainty that no harm will 
result from dietary exposure to residues of iprovalicarb.

V. Conclusion

    Therefore, the tolerance is established for residues of 
iprovalicarb, [[1-methylethyl [(1S)-2-methyl-1-[[[1-(4-methylphenyl) 
ethyl] amino] carbonyl] propyl carbamate, in or on tomatoes at 1.0 ppm.

VI. Objections and Hearing Requests

    Under section 408(g) of FFDCA, as amended by 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 FFDCA by FQPA, EPA 
will continue to use those procedures, with appropriate adjustments, 
until the necessary modifications can be made.The new section 408(g) of 
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 FFDCA, as was provided in the 
old sections 408 and 409 of 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-2005-0074 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 November 
21, 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 178.25). If a hearing is requested, the 
objections must include a statement of the factual issue(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 14\th\ 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 VI.A., you 
should also send a copy of your request to the PIRIB for its inclusion 
in the official record that is described in ADDRESSES. Mail your 
copies, identified by docket ID number OPP-2005-0074, to: Public 
Information

[[Page 55281]]

and Records Integrity Branch, Information Technology and Resource 
Management 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 issue(s) in the manner sought 
by the requestor would be adequate to justify the action requested (40 
CFR 178.32).

VII. Statutory and Executive Order Reviews

    This final rule establishes a tolerance 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 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 
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. 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 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.

VIII. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801et 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 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: September 12, 2005.
Meredith F. Laws,
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 180.581 is amended by alphabetically adding ``tomatoes'' in 
the table in paragraph (a) and by revising footnote 1 to read as 
follows:


Sec.  180.581  Iprovalicarb; tolerances for residues.

    (a) * * *

[[Page 55282]]



------------------------------------------------------------------------
                   Commodity                        Parts per million
------------------------------------------------------------------------
                                * * * * *
Tomatoes\1\....................................                      1.0
------------------------------------------------------------------------
\1\There is no U.S. registration as of September 1, 2005.

* * * * *

[FR Doc. 05-18828 Filed 9-20-05; 8:45 am]
BILLING CODE 6560-50-S