[Federal Register Volume 70, Number 184 (Friday, September 23, 2005)]
[Rules and Regulations]
[Pages 55748-55752]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-19061]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-2005-0017; FRL-7736-4]
Kasugamycin; Pesticide Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation establishes a tolerance forresidues of
kasugamycin in or on fruiting vegetables, crop group 8. Arysta
Lifescience North American Corporation (previously know as Arvesta
Corporation), agent for Hokko Chemical Industry Corporation, 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 23, 2005. Objections and
requests for hearings must be received on or before November 22, 2005.
ADDRESSES: To submit a written objection or hearing request follow the
detailed instructions as provided in Unit VI. of theSUPPLEMENTARY
INFORMATION. EPA has established a docket for this action under Docket
identification (ID) number OPP-2005-0017. 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 Mall2, 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 affected entities may include, but are not limited to:
Crop production (NAICS 111), e.g., agricultural workers;
greenhouse, nursery, and floriculture workers; farmers.
Animal production (NAICS 112), e.g., cattle ranchers and
farmers, dairy cattle farmers, livestock farmers.
Food manufacturing (NAICS 311), e.g., agricultural
workers; farmers; greenhouse, nursery, and floriculture workers;
ranchers; pesticide applicators.
Pesticide manufacturing (NAICS 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/.
To access the OPPTS Harmonized Guidelines referenced in this document,
go directly to the guidelines at http://www.epa.gpo/opptsfrs/home/guidelin.htm/.
II. Background and Statutory Findings
In the Federal Register of April 8, 2005 (70 FR 17997) (FRL-7704-
2), 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
3E6579) by Arysta Lifescience North American Corporation, 100 First
Street, Ste. 1700; San Fransisco, CA 94105; agent for Hokko Chemical
Industry Corporation Ltd., 4-20, Nihonbashi Hongochkucho 4 Chome, Chuo-
Ku, Tokyo 103-8341, Japan. The petition requested that 40 CFR part 180
be amended by establishing a tolerance for residues of the fungicide
kasugamycin, 1L-1,3,4/2,5,6-1-deoxy-2,3,4,5,6-pentahydroxy-cyclohexyl-
2-amino-2,3,4,6-tetradeoxy-4-([[alpha]]-iminoglycino)-[[alpha]]-D-
arabino-hexapyranoside, in or on fruiting vegetables (Crop Group 8) at
0.04 parts per million (ppm), tomato juice at 0.06 ppm, tomato puree at
0.06 ppm, and tomato paste at 0.25 ppm. That notice included a summary
of the petition prepared by Arysta Life Science North American
Corporation, agent for Hokko Chemical Industry Corporation, LLC, 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, see http://
[[Page 55749]]
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 kasugamycin on
fruiting vegetables(Crop Group 8) at 0.04 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 kasugamycin 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 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 of EPA uses in risk
characterization at http://www.epa.gov/oppfead1/trac/science/.
A summary of the toxicological endpoints for kasugamycin used for
human risk assessment is shown in Table 1 of this unit:
Table 1.--Summary of Toxicological Dose and Endpoints for kasugamycin for Use in Human Risk Assessment
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Dose Used in Risk
Assessment, Special FQPA SF and
Exposure/Scenario Interspecies and Level of Concern for Study and Toxicological
Intraspecies and any Risk Assessment Effects
Traditional UF
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Acute dietary (females 13-50 years of None None Not Selected
age and general population including No appropriate dose and
infants and children) endpoint could
beidentified for these
population groups
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Chronic dietary (all populations) NOAEL = 11.3 mg/kg/day Special FQPA SF = 1 Combined chronic
UF = 100............... cPAD = chronic RfD/ toxicity/oncogenicity
Chronic RfD = 0.113 mg/ Special FQPA SF = study in rats
kg/day. 0.113 mg/kg/day. LOAEL = 116 mg/kg/day
based on increased
testicular softening
and atrophy
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Cancer (oral, dermal, inhalation) Classification: No oncogenic potential was noted in the mouse
oncogenicity or in the rat combined chronic/carcinogenicity studies;
additionally, no mutagenic potential was noted in any of the five
mutagenicity studies. Classification of kasugamycin is ``not likely to
be carcinogenic to humans.''
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C. Exposure Assessment
1. Dietary exposure from food and feed uses. This final rule
reflects the establishment of the first tolerance for kasugamycin.
Since there are no registered uses in the United States, the only
exposure expected is from imported foods. Risk assessments were
conducted by EPA to assess dietary exposures from kasugamycin 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
kasugamycin; therefore, a quantitative acute dietary exposure
assessment is unnecessary. No appropriate dose or endpoint could be
identified for acute dietary exposure in the general population or any
population subgroup.
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\), 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.
The following assumptions were made for the chronic exposure
assessments: The analysis is based on tolerance-level residues
(modified by DEEM default processing factors for tomato processed
commodities) and the assumption that 100% of the crop will be treated.
iii. Cancer. The Agency classified kasugamycin as ``not likely to
be carcinogenic to humans,'' based on the lack of evidence of
carcinogenicity in mice and rats. Therefore, a quantitative cancer
exposure assessment was not conducted.
2. Dietary exposure from drinking water. There is no expectation
that kasugamycin residues would occur in surface or ground water
sources of drinking water. There are no registered uses of kasugamycin
in the United States.
3. From non-dietary exposure. The term ``residential exposure'' is
used in this document to refer to non-
[[Page 55750]]
occupational, non-dietary exposure (e.g., for lawn and garden pest
control, indoor pest control, termiticides, and flea and tick control
on pets).
Kasugamycin 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.''
Unlike other pesticides for which EPA has followed a cumulative
risk approach based on a common mechanism of toxicity, EPA has not made
a common mechanism of toxicity finding as to kasugamycin and any other
substances and kasugamycin does not appear to produce a toxic
metabolite produced by other substances. For the purposes of this
tolerance action, therefore, EPA has not assumed that kasugamycin has a
common mechanism of toxicity with other substances. 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 at http://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. No increased quantitative or
qualitative susceptibility was observed in the developmental rat or
rabbit studies or in the 2-generation reproduction study. No offspring
toxicity was observed at any of the doses tested in these three
studies. Reproductive toxicity was noted in the F1 generation of the 2-
generation reproduction study. However, because parental toxicity
(decreased body weights and body weight gains) occured at a lower dose
than that which resulted in effects on reproduction, there is no
increased quantitative or qualitative susceptibility of the offspring.
The toxicology database for kasugamycin is complete with respect to
prenatal and postnatal toxicity and shows no evidence of increased
qualitative or quantitative susceptibility in the offspring. Therefore,
there are no residual uncertainties for prenatal and/or postnatal
toxicity.
3. Conclusion. There is a complete toxicity data base for
kasugamycin and exposure data are complete or are estimated based on
data that reasonably accounts for potential exposures. Additionally, a
developmental neurotoxicity study is not required because there was no
evidence of neurotoxicity in any studies. Based on the above
information, EPA concludes that it has reliable data that supports the
conclusion that it is safe to remove the additional children's safety
factor.
E. Aggregate Risks and Determination of Safety
1. Acute risk. No appropriate dose or endpoint was identified for
acute dietary exposure in the general population or any population
subgroup. Therefore, no acute risk is expected from exposure to
Kasugamycin.
2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that exposure to
kasugamycin from food will utilize < 1% of the cPAD for the U.S.
population, < 1% of the cPAD for all infants < 1-year, and < 1% of the
cPAD for children 1-2 years. There are no residential uses for
kasugamycin that result in chronic residential exposure to kasugamycin,
and no exposure is expected from drinking water. EPA does not expect
the aggregate exposure (dietary only) 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
Kasugamycin
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cPAD (mg/kg/ %cPAD
Population/Subgroup day (Food)
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U.S. population 0.113 <1
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All Infants (< 1 yr) 0.113 <1
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Children 1-2 yrs 0.113 <1
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3. Short-term risk. Short-term aggregate exposure takes into
account residential exposure plus chronic exposure to food and water
(considered to be a background exposure level.)
Kasugamycin is not registered for use on any sites that would
result in residential exposure, and the tolerance in this rule is for
imported fruiting vegetables (crop group 8). No exposure is expected
from drinking water. Therefore, the aggregate risk is from food only,
and which does not exceed the Agency's level of concern.
4. Intermediate-term risk. Intermediate-term aggregate exposure
takes into account residential exposure plus chronic exposure to food
and water (considered to be a background exposure level).
Kasugamycin is not registered for use on any sites that would
result in residential exposure, and the tolerance in this rule is for
imported fruiting vegetables (crop group 8). No exposure is expected
from drinking water. Therefore, the aggregate risk is from food only,
and which does not exceed the Agency's level of concern.
5. Aggregate cancer risk for U.S. population. Kasugamycin has not
been shown to be carcinogenic. Therefore, kasugamycin is not expected
to pose a cancer 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 kasugamycin residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
The analytical enforcement method uses ion exchange resins for
clean up and reverse-phase ion-pairing liquid chromatography with
ultra-violet detection (HPLC/UV). This method was validated by an
independent laboratory. The Agency's laboratory also conducted a
laboratory trial of this method and has determined the method
performance to
[[Page 55751]]
be useful as an enforcement method with the incorporated revisions
recommended by the petitioner.
The method (HPLC/UV) 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 currently no established Codex, Canadian, or Mexican MRLs
for kasugamycin.
C. Response to Comments
Comments were received from a private citizen on the notice of
filing for kasugamycin on April 17, 2005 objecting to this proposed
tolerance. The comments further stated that not enough tests have been
completed (long term or tests on how it combines) and that there is
little indication of safety.
The Agency response is as follows: The Agency has a complete
toxicity database on kasugamycin, including several long-term or
chronic studies. Further, EPA has not made a common mechanism of
toxicity finding as to kasugamycin and any other substances and
kasugamycin does not appear to produce a toxic metabolite produced by
other substances. The commenter submitted no scientific information or
contention in support of the commenter's claims.
V. Conclusion
Therefore, the tolerance is established for residues of
kasugamycin, [3-O-[2-amino-4-[(carboxyiminomethyl)amino]-2,3,4,6-
tetradeoxy-[alpha]-D-arabino-hexopyranosyl]-D-chiro-inositol]], in or
on fruiting vegetables (Crop Group 8) at 0.04 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-2005-0017 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
22, 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-2005-0017, to: Public
Information 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,
[[Page 55752]]
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 15, 2005.
James Jones,
Director, 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 180.614 is added to read as follows:
Sec. 180.614 Kasugamycin; tolerances for residues.
(a) General. Tolerances are established for residues of
kasugamycin, 3-O-[2-amino-4-[(carboxyiminomethyl)amino]-2,3,4,6-
tetradeoxy-[alpha]-D-arabino-hexopyranosyl]-D-chiro-inositol in or on
the following raw agricultural commodity:
------------------------------------------------------------------------
Commodity Parts per million
------------------------------------------------------------------------
Vegetable, fruiting group 8\1\....................... 0.04
------------------------------------------------------------------------
\1\There is no U.S. registration as of September 1, 2005.
(b) Section 18 emergency exemptions. [Reserved]
(c) Tolerances with regional registrations. [Reserved]
(d) Indirect or inadvertent residues. [Reserved]
[FR Doc. 05-19061 Filed 9-22-05; 8:45 am]
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