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55748 Federal Register / Vol. 70, No.

184 / Friday, September 23, 2005 / Rules and Regulations

Parts per holidays. The docket telephone number to the guidelines at http://www.epa.gpo/
Commodity million is (703) 305–5805. opptsfrs/home/guidelin.htm/.
FOR FURTHER INFORMATION CONTACT: II. Background and Statutory Findings
* * * * *
Pea, succulent .......................... 0.02 Mary L. Waller, Registration Division In the Federal Register of April 8,
* * * * * (7505C), Office of Pesticide Programs,
Salal .......................................... 3.0 Environmental Protection Agency, 1200
2005 (70 FR 17997) (FRL–7704–2), EPA
* * * * * Pennsylvania Ave., NW., Washington, issued a notice pursuant to section
Vegetable, fruiting, group 8 ...... 1.0 DC 20460–0001; telephone number: 408(d)(3) of FFDCA, 21 U.S.C.
(703) 308–9354; e-mail address: 346a(d)(3), announcing the filing of a
* * * * * waller.mary@epa.gov. pesticide petition (PP 3E6579) by Arysta
Lifescience North American
[FR Doc. 05–19062 Filed 9–22–05; 8:45 am] SUPPLEMENTARY INFORMATION: Corporation, 100 First Street, Ste. 1700;
BILLING CODE 6560–50–S
I. General Information San Fransisco, CA 94105; agent for
Hokko Chemical Industry Corporation
A. Does this Action Apply to Me? Ltd., 4-20, Nihonbashi Hongochkucho 4
ENVIRONMENTAL PROTECTION
You may be potentially affected by Chome, Chuo-Ku, Tokyo 103–8341,
AGENCY
this action if you are an agricultural Japan. The petition requested that 40
40 CFR Part 180 producer, food manufacturer, or CFR part 180 be amended by
pesticide manufacturer. Potentially establishing a tolerance for residues of
[OPP–2005–0017; FRL–7736–4] affected entities may include, but are the fungicide kasugamycin, 1L-1,3,4/
not limited to: 2,5,6-1-deoxy-2,3,4,5,6-pentahydroxy-
Kasugamycin; Pesticide Tolerance • Crop production (NAICS 111), e.g., cyclohexyl-2-amino-2,3,4,6-tetradeoxy-
agricultural workers; greenhouse, 4-([a]-iminoglycino)-[a]-D-arabino-
AGENCY: Environmental Protection nursery, and floriculture workers; hexapyranoside, in or on fruiting
Agency (EPA). farmers. vegetables (Crop Group 8) at 0.04 parts
ACTION: Final rule. • Animal production (NAICS 112), per million (ppm), tomato juice at 0.06
e.g., cattle ranchers and farmers, dairy ppm, tomato puree at 0.06 ppm, and
SUMMARY: This regulation establishes a tomato paste at 0.25 ppm. That notice
cattle farmers, livestock farmers.
tolerance forresidues of kasugamycin in • Food manufacturing (NAICS 311), included a summary of the petition
or on fruiting vegetables, crop group 8. e.g., agricultural workers; farmers; prepared by Arysta Life Science North
Arysta Lifescience North American greenhouse, nursery, and floriculture American Corporation, agent for Hokko
Corporation (previously know as workers; ranchers; pesticide applicators. Chemical Industry Corporation, LLC,
Arvesta Corporation), agent for Hokko the registrant. Comments were received
• Pesticide manufacturing (NAICS
Chemical Industry Corporation, on the notice of filing. EPA’s response
32532), e.g., agricultural workers;
requested this tolerance under the to these comments is discussed in Unit
commercial applicators; farmers;
Federal Food, Drug, and Cosmetic Act IV.C. below.
greenhouse, nursery, and floriculture
(FFDCA), as amended by the Food Section 408(b)(2)(A)(i) of FFDCA
workers; residential users.
Quality Protection Act of 1996 (FQPA). allows EPA to establish a tolerance (the
This listing is not intended to be
DATES: This regulation is effective exhaustive, but rather provides a guide legal limit for a pesticide chemical
September 23, 2005. Objections and for readers regarding entities likely to be residue in or on a food) only if EPA
requests for hearings must be received affected by this action. Other types of determines that the tolerance is ‘‘safe.’’
on or before November 22, 2005. entities not listed in this unit could also Section 408(b)(2)(A)(ii) of FFDCA
ADDRESSES: To submit a written be affected. The North American defines ‘‘safe’’ to mean that ‘‘there is a
objection or hearing request follow the Industrial Classification System reasonable certainty that no harm will
detailed instructions as provided in (NAICS) codes have been provided to result from aggregate exposure to the
Unit VI. of theSUPPLEMENTARY assist you and others in determining pesticide chemical residue, including
INFORMATION. EPA has established a whether this action might apply to all anticipated dietary exposures and all
docket for this action under Docket certain entities. If you have any other exposures for which there is
identification (ID) number OPP–2005– questions regarding the applicability of reliable information.’’ This includes
0017. All documents in the docket are this action to a particular entity, consult exposure through drinking water and in
listed in the EDOCKET index athttp:// the person listed underFOR FURTHER residential settings, but does not include
www.epa.gov/edocket. Although listed INFORMATION CONTACT. occupational exposure. Section
in the index, some information is not 408(b)(2)(C) of FFDCA requires EPA to
publicly available, i.e., CBI or other B. How Can I Access Electronic Copies give special consideration to exposure
information whose disclosure is of this Document and Other Related of infants and children to the pesticide
restricted by statute. Certain other Information? chemical residue in establishing a
material, such as copyrighted material, In addition to using EDOCKET (http:// tolerance and to ‘‘ensure that there is a
is not placed on the Internet and will be www.epa.gov/edocket/), you may access reasonable certainty that no harm will
publicly available only in hard copy this Federal Register document result to infants and children from
form. Publicly available docket electronically through the EPA Internet aggregate exposure to the pesticide
materials are available either under the ‘‘Federal Register’’ listings at chemical residue. . . .’’
electronically in EDOCKET or in hard http://www.epa.gov/fedrgstr/. A EPA performs a number of analyses to
copy at the Public Information and frequently updated electronic version of determine the risks from aggregate
Records Integrity Branch (PIRIB), Rm. 40 CFR part 180 is available at E-CFR exposure to pesticide residues. For
119, Crystal Mall#2, 1801 S. Bell St., Beta Site Two at http:// further discussion of the regulatory
Arlington, VA. This docket facility is www.gpoaccess.gov/ecfr/. To access the requirements of section 408 of FFDCA
open from 8:30 a.m. to 4 p.m., Monday OPPTS Harmonized Guidelines and a complete description of the risk
through Friday, excluding legal referenced in this document, go directly assessment process, see http://

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Federal Register / Vol. 70, No. 184 / Friday, September 23, 2005 / Rules and Regulations 55749

www.epa.gov/pesticides/factsheets/ considered available information was achieved in the toxicology study


riskassess.htm concerning the variability of the selected. An uncertainty factor (UF) is
sensitivities of major identifiable applied to reflect uncertainties inherent
III. Aggregate Risk Assessment and
subgroups of consumers, including in the extrapolation from laboratory
Determination of Safety
infants and children. Specific animal data to humans and in the
Consistent with section 408(b)(2)(D) information on the studies received and variations in sensitivity among members
of FFDCA, EPA has reviewed the the nature of the toxic effects caused by of the human population as well as
available scientific data and other kasugamycin as well as the no observed other unknowns.
relevant information in support of this adverse effect level (NOAEL) and the The linear default risk methodology
action. EPA has sufficient data to assess lowest observed adverse effect level (Q*) is the primary method currently
the hazards of and to make a (LOAEL) from the toxicity studies can used by the Agency to quantify non-
determination on aggregate exposure, be found at http://www.epa.gov/edocket. threshold hazards such as cancer. The
consistent with section 408(b)(2) of
Q* approach assumes that any amount
FFDCA, for a tolerance for residues of B. Toxicological Endpoints
of exposure will lead to some degree of
kasugamycin on fruiting
For hazards that have a threshold cancer risk, estimates risk in terms of
vegetables(Crop Group 8) at 0.04 ppm.
EPA’s assessment of exposures and risks below which there is no appreciable the probability of occurrence of
associated with establishing the risk, the dose at which no adverse additional cancer cases. More
tolerance follows. effects are observed (the NOAEL) from information can be found on the general
the toxicology study identified as principles of EPA uses in risk
A. Toxicological Profile appropriate for use in risk assessment is characterization at http://www.epa.gov/
EPA has evaluated the available used to estimate the toxicological level oppfead1/trac/science/.
toxicity data and considered its validity, of concern (LOC). However, the lowest A summary of the toxicological
completeness, and reliability as well as dose at which adverse effects of concern endpoints for kasugamycin used for
the relationship of the results of the are identified (the LOAEL) is sometimes human risk assessment is shown in
studies to human risk. EPA has also used for risk assessment if no NOAEL Table 1 of this unit:

TABLE 1.—SUMMARY OF TOXICOLOGICAL DOSE AND ENDPOINTS FOR KASUGAMYCIN FOR USE IN HUMAN RISK
ASSESSMENT
Dose Used in Risk Assess- Special FQPA SF and
ment, Interspecies and
Exposure/Scenario Level of Concern for Risk Study and Toxicological Effects
Intraspecies and any Tradi- Assessment
tional UF

Acute dietary (females 13–50 None None Not Selected


years of age and general No appropriate dose and endpoint could
population including infants beidentified for these population groups
and children)

Chronic dietary (all populations) NOAEL = 11.3 mg/kg/day Special FQPA SF = 1 Combined chronic toxicity/oncogenicity study
UF = 100 cPAD = chronic RfD/Spe- in rats
Chronic RfD = 0.113 mg/kg/ cial FQPA SF = 0.113 LOAEL = 116 mg/kg/day based on increased
day mg/kg/day testicular softening and atrophy

Cancer (oral, dermal, inhala- Classification: No oncogenic potential was noted in the mouse oncogenicity or in the rat combined chronic/
tion) 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.’’

C. Exposure Assessment therefore, a quantitative acute dietary residues (modified by DEEM default
exposure assessment is unnecessary. No processing factors for tomato processed
1. Dietary exposure from food and appropriate dose or endpoint could be commodities) and the assumption that
feed uses. This final rule reflects the identified for acute dietary exposure in 100% of the crop will be treated.
establishment of the first tolerance for the general population or any iii. Cancer. The Agency classified
kasugamycin. Since there are no population subgroup. kasugamycin as ‘‘not likely to be
registered uses in the United States, the ii. Chronic exposure. In conducting carcinogenic to humans,’’ based on the
only exposure expected is from the chronic dietary exposure assessment lack of evidence of carcinogenicity in
imported foods. Risk assessments were EPA used the Dietary Exposure mice and rats. Therefore, a quantitative
conducted by EPA to assess dietary Evaluation Model software with the cancer exposure assessment was not
exposures from kasugamycin in food as Food Commodity Intake Database conducted.
follows: (DEEM-FCIDTM), which incorporates 2. Dietary exposure from drinking
i. Acute exposure. Quantitative acute food consumption data as reported by water. There is no expectation that
dietary exposure and risk assessments respondents in the USDA 1994–1996 kasugamycin residues would occur in
are performed for a food-use pesticide, and 1998 Nationwide Continuing surface or ground water sources of
if a toxicological study has indicated the Surveys of Food Intake by Individuals drinking water. There are no registered
possibility of an effect of concern (CSFII), and accumulated exposure to uses of kasugamycin in the United
occurring as a result of a 1–day or single the chemical for each commodity. The States.
exposure. following assumptions were made for 3. From non-dietary exposure. The
No such effects were identified in the the chronic exposure assessments: The term ‘‘residential exposure’’ is used in
toxicological studies for kasugamycin; analysis is based on tolerance-level this document to refer to non-

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55750 Federal Register / Vol. 70, No. 184 / Friday, September 23, 2005 / Rules and Regulations

occupational, non-dietary exposure the use of traditional uncertainty factors TABLE 2.—AGGREGATE RISK ASSESS-
(e.g., for lawn and garden pest control, and/or special FQPA safety factors, as MENT FOR CHRONIC (NON-CANCER)
indoor pest control, termiticides, and appropriate. EXPOSURE TO KASUGAMYCIN
flea and tick control on pets). 2. Prenatal and postnatal sensitivity.
Kasugamycin is not registered for use Population/ cPAD (mg/ %cPAD
on any sites that would result in No increased quantitative or qualitative
Subgroup kg/day (Food)
residential exposure. susceptibility was observed in the
4. Cumulative effects from substances developmental rat or rabbit studies or in U.S. popu-
with a common mechanism of toxicity. the 2–generation reproduction study. No lation 0.113 <1
Section 408(b)(2)(D)(v) of the FFDCA offspring toxicity was observed at any of
the doses tested in these three studies. All Infants (< 1
requires that, when considering whether
yr) 0.113 <1
to establish, modify, or revoke a Reproductive toxicity was noted in the
tolerance, the Agency consider F1 generation of the 2–generation Children 1-2
‘‘available information’’ concerning the reproduction study. However, because yrs 0.113 <1
cumulative effects of a particular parental toxicity (decreased body
pesticide’s residues and ‘‘other weights and body weight gains) occured 3. Short-term risk. Short-term
substances that have a common at a lower dose than that which resulted aggregate exposure takes into account
mechanism of toxicity.’’ in effects on reproduction, there is no residential exposure plus chronic
Unlike other pesticides for which EPA increased quantitative or qualitative exposure to food and water (considered
has followed a cumulative risk approach susceptibility of the offspring. The to be a background exposure level.)
based on a common mechanism of toxicology database for kasugamycin is Kasugamycin is not registered for use
toxicity, EPA has not made a common on any sites that would result in
complete with respect to prenatal and
mechanism of toxicity finding as to residential exposure, and the tolerance
kasugamycin and any other substances postnatal toxicity and shows no
evidence of increased qualitative or in this rule is for imported fruiting
and kasugamycin does not appear to vegetables (crop group 8). No exposure
produce a toxic metabolite produced by quantitative susceptibility in the
offspring. Therefore, there are no is expected from drinking water.
other substances. For the purposes of Therefore, the aggregate risk is from
this tolerance action, therefore, EPA has residual uncertainties for prenatal and/
food only, and which does not exceed
not assumed that kasugamycin has a or postnatal toxicity.
the Agency’s level of concern.
common mechanism of toxicity with 3. Conclusion. There is a complete 4. Intermediate-term risk.
other substances. For information toxicity data base for kasugamycin and Intermediate-term aggregate exposure
regarding EPA’s efforts to determine exposure data are complete or are takes into account residential exposure
which chemicals have a common estimated based on data that reasonably plus chronic exposure to food and water
mechanism of toxicity and to evaluate accounts for potential exposures. (considered to be a background
the cumulative effects of such Additionally, a developmental exposure level).
chemicals, see the policy statements neurotoxicity study is not required Kasugamycin is not registered for use
released by EPA’s Office of Pesticide on any sites that would result in
because there was no evidence of
Programs concerning common residential exposure, and the tolerance
neurotoxicity in any studies. Based on
mechanism determinations and in this rule is for imported fruiting
procedures for cumulating effects from the above information, EPA concludes
that it has reliable data that supports the vegetables (crop group 8). No exposure
substances found to have a common is expected from drinking water.
mechanism on EPA’s website at http:// conclusion that it is safe to remove the
additional children’s safety factor. Therefore, the aggregate risk is from
www.epa.gov/pesticides/cumulative/. food only, and which does not exceed
D. Safety Factor for Infants and E. Aggregate Risks and Determination of the Agency’s level of concern.
Children Safety 5. Aggregate cancer risk for U.S.
1. In general. Section 408 of FFDCA population. Kasugamycin has not been
1. Acute risk. No appropriate dose or shown to be carcinogenic. Therefore,
provides that EPA shall apply an endpoint was identified for acute
additional tenfold margin of safety for kasugamycin is not expected to pose a
dietary exposure in the general cancer risk.
infants and children in the case of population or any population subgroup. 6. Determination of safety. Based on
threshold effects to account for prenatal Therefore, no acute risk is expected these risk assessments, EPA concludes
and postnatal toxicity and the
from exposure to Kasugamycin. that there is a reasonable certainty that
completeness of the data base on
2. Chronic risk. Using the exposure no harm will result to the general
toxicity and exposure unless EPA
assumptions described in this unit for population, and to infants and children
determines based on reliable data that a
chronic exposure, EPA has concluded from aggregate exposure to kasugamycin
different margin of safety will be safe for
that exposure to kasugamycin from food residues.
infants and children. Margins of safety
are incorporated into EPA risk will utilize < 1% of the cPAD for the IV. Other Considerations
assessments either directly through use U.S. population, < 1% of the cPAD for
A. Analytical Enforcement Methodology
of a margin of exposure analysis or all infants < 1–year, and < 1% of the
through using uncertainty (safety) cPAD for children 1-2 years. There are The analytical enforcement method
factors in calculating a dose level that no residential uses for kasugamycin that uses ion exchange resins for clean up
poses no appreciable risk to humans. In result in chronic residential exposure to and reverse-phase ion-pairing liquid
applying this provision, EPA either kasugamycin, and no exposure is chromatography with ultra-violet
retains the default value of 10X when expected from drinking water. EPA does detection (HPLC/UV). This method was
reliable data do not support the choice not expect the aggregate exposure validated by an independent laboratory.
of a different factor, or, if reliable data (dietary only) to exceed 100% of the The Agency’s laboratory also conducted
are available, EPA uses a different cPAD as shown in Table 2 of this unit. a laboratory trial of this method and has
additional safety factor value based on determined the method performance to

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Federal Register / Vol. 70, No. 184 / Friday, September 23, 2005 / Rules and Regulations 55751

be useful as an enforcement method section 408(d) of FFDCA, as was Ave., NW., Washington, DC 20460–
with the incorporated revisions provided in the old sections 408 and 0001. In person or by courier, bring a
recommended by the petitioner. 409 of FFDCA. However, the period for copy to the location of the PIRIB
The method (HPLC/UV) may be filing objections is now 60 days, rather described in ADDRESSES. You may also
requested from: Chief, Analytical than 30 days. send an electronic copy of your request
Chemistry Branch, Environmental via e-mail to: opp-docket@epa.gov.
A. What Do I Need to Do to File an
Science Center, 701 Mapes Rd., Ft. Please use an ASCII file format and
Objection or Request a Hearing?
Meade, MD 20755–5350; telephone avoid the use of special characters and
number: (410) 305–2905; e-mail address: You must file your objection or any form of encryption. Copies of
residuemethods@epa.gov. request a hearing on this regulation in electronic objections and hearing
accordance with the instructions requests will also be accepted on disks
B. International Residue Limits provided in this unit and in 40 CFR part in WordPerfect 6.1/8.0 or ASCII file
There are currently no established 178. To ensure proper receipt by EPA, format. Do not include any CBI in your
Codex, Canadian, or Mexican MRLs for you must identify docket ID number electronic copy. You may also submit an
kasugamycin. OPP–2005–0017 in the subject line on electronic copy of your request at many
the first page of your submission. All Federal Depository Libraries.
C. Response to Comments requests must be in writing, and must be
Comments were received from a mailed or delivered to the Hearing Clerk B. When Will the Agency Grant a
private citizen on the notice of filing for on or before November 22, 2005. Request for a Hearing?
kasugamycin on April 17, 2005 1. Filing the request. Your objection A request for a hearing will be granted
objecting to this proposed tolerance. must specify the specific provisions in if the Administrator determines that the
The comments further stated that not the regulation that you object to, and the material submitted shows the following:
enough tests have been completed (long grounds for the objections (40 CFR There is a genuine and substantial issue
term or tests on how it combines) and 178.25). If a hearing is requested, the of fact; there is a reasonable possibility
that there is little indication of safety. objections must include a statement of that available evidence identified by the
The Agency response is as follows: the factual issue(s) on which a hearing requestor would, if established resolve
The Agency has a complete toxicity is requested, the requestor’s contentions one or more of such issues in favor of
database on kasugamycin, including on such issues, and a summary of any the requestor, taking into account
several long-term or chronic studies. evidence relied upon by the objector (40 uncontested claims or facts to the
Further, EPA has not made a common CFR 178.27). Information submitted in contrary; and resolution of the factual
mechanism of toxicity finding as to connection with an objection or hearing issue(s) in the manner sought by the
kasugamycin and any other substances request may be claimed confidential by requestor would be adequate to justify
and kasugamycin does not appear to marking any part or all of that the action requested (40 CFR 178.32).
produce a toxic metabolite produced by information as CBI. Information so
marked will not be disclosed except in VII. Statutory and Executive Order
other substances. The commenter
accordance with procedures set forth in Reviews
submitted no scientific information or
contention in support of the 40 CFR part 2. A copy of the This final rule establishes a tolerance
commenter’s claims. information that does not contain CBI under section 408(d) of FFDCA in
must be submitted for inclusion in the response to a petition submitted to the
V. Conclusion public record. Information not marked Agency. The Office of Management and
Therefore, the tolerance is established confidential may be disclosed publicly Budget (OMB) has exempted these types
for residues of kasugamycin, [3-O-[2- by EPA without prior notice. of actions from review under Executive
amino-4-[(carboxyiminomethyl)amino]- Mail your written request to: Office of Order 12866, entitled Regulatory
2,3,4,6-tetradeoxy-a-D-arabino- the Hearing Clerk (1900L), Planning and Review (58 FR 51735,
hexopyranosyl]-D-chiro-inositol]], in or Environmental Protection Agency, 1200 October 4, 1993). Because this rule has
on fruiting vegetables (Crop Group 8) at Pennsylvania Ave., NW., Washington, been exempted from review under
0.04 ppm. DC 20460–0001. You may also deliver Executive Order 12866 due to its lack of
your request to the Office of the Hearing significance, this rule is not subject to
VI. Objections and Hearing Requests Clerk in Suite 350, 1099 14th St., NW., Executive Order 13211, Actions
Under section 408(g) of FFDCA, as Washington, DC 20005. The Office of Concerning Regulations That
amended by FQPA, any person may file the Hearing Clerk is open from 8 a.m. Significantly Affect Energy Supply,
an objection to any aspect of this to 4 p.m., Monday through Friday, Distribution, or Use (66 FR 28355, May
regulation and may also request a excluding legal holidays. The telephone 22, 2001). This final rule does not
hearing on those objections. The EPA number for the Office of the Hearing contain any information collections
procedural regulations which govern the Clerk is (202) 564–6255. subject to OMB approval under the
submission of objections and requests 2. Copies for the Docket. In addition Paperwork Reduction Act (PRA), 44
for hearings appear in 40 CFR part 178. to filing an objection or hearing request U.S.C. 3501 et seq., or impose any
Although the procedures in those with the Hearing Clerk as described in enforceable duty or contain any
regulations require some modification to Unit VI.A., you should also send a copy unfunded mandate as described under
reflect the amendments made to FFDCA of your request to the PIRIB for its Title II of the Unfunded Mandates
by FQPA, EPA will continue to use inclusion in the official record that is Reform Act of 1995 (UMRA) (Public
those procedures, with appropriate described in ADDRESSES. Mail your Law 104–4). Nor does it require any
adjustments, until the necessary copies, identified by docket ID number special considerations under Executive
modifications can be made. The new OPP–2005–0017, to: Public Information Order 12898, entitled Federal Actions to
section 408(g) of FFDCA provides and Records Integrity Branch, Address Environmental Justice in
essentially the same process for persons Information Technology and Resource Minority Populations and Low-Income
to ‘‘object’’ to a regulation for an Management Division (7502C), Office of Populations (59 FR 7629, February 16,
exemption from the requirement of a Pesticide Programs, Environmental 1994); or OMB review or any Agency
tolerance issued by EPA under new Protection Agency, 1200 Pennsylvania action under Executive Order 13045,

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entitled Protection of Children from Government and the Indian tribes, or on Commodity Parts per million
Environmental Health Risks and Safety the distribution of power and
Risks (62 FR 19885, April 23, 1997). responsibilities between the Federal Vegetable, fruiting group
This action does not involve any Government and Indian tribes.’’ This 81 ................................. 0.04
technical standards that would require rule will not have substantial direct 1There is no U.S. registration as of Sep-
Agency consideration of voluntary effects on tribal governments, on the tember 1, 2005.
consensus standards pursuant to section relationship between the Federal (b) Section 18 emergency exemptions.
12(d) of the National Technology Government and Indian tribes, or on the [Reserved]
Transfer and Advancement Act of 1995 distribution of power and (c) Tolerances with regional
(NTTAA), Public Law 104–113, section responsibilities between the Federal registrations. [Reserved]
12(d) (15 U.S.C. 272 note). Since Government and Indian tribes, as (d) Indirect or inadvertent residues.
tolerances and exemptions that are specified in Executive Order 13175. [Reserved]
established on the basis of a petition Thus, Executive Order 13175 does not [FR Doc. 05–19061 Filed 9–22–05; 8:45 am]
under section 408(d) of FFDCA, such as apply to this rule. BILLING CODE 6560–50–S
the tolerance in this final rule, do not
require the issuance of a proposed rule, VIII. Congressional Review Act
the requirements of the Regulatory ENVIRONMENTAL PROTECTION
Flexibility Act (RFA) (5 U.S.C. 601 et The Congressional Review Act, 5
U.S.C. 801et seq., as added by the Small AGENCY
seq.) do not apply. In addition, the
Agency has determined that this action Business Regulatory Enforcement
40 CFR Part 180
will not have a substantial direct effect Fairness Act of 1996, generally provides
on States, on the relationship between that before a rule may take effect, the [OPP–2005–0185; FRL–7736–3]
the national government and the States, agency promulgating the rule must
submit a rule report, which includes a Amicarbazone; Pesticide Tolerance
or on the distribution of power and
responsibilities among the various copy of the rule, to each House of the AGENCY: Environmental Protection
levels of government, as specified in Congress and to the Comptroller General Agency (EPA).
Executive Order 13132, entitled of the United States. EPA will submit a ACTION: Final rule.
Federalism(64 FR 43255, August 10, report containing this rule and other
1999). Executive Order 13132 requires required information to the U.S. Senate, SUMMARY: This regulation establishes
EPA to develop an accountable process the U.S. House of Representatives, and tolerances for combined residues of
to ensure ‘‘meaningful and timely input the Comptroller General of the United amicarbazone and its metabolites in or
by State and local officials in the States prior to publication of this final on field corn and livestock commodities
development of regulatory policies that rule in the Federal Register. This final and indirect or inadvertent residues of
have federalism implications.’’ ‘‘Policies rule is not a ‘‘major rule’’ as defined by amicarbazone and its metabolites in
that have federalism implications’’ is 5 U.S.C. 804(2). alfalfa, cotton, soybean and wheat.
defined in the Executive Order to Arysta Lifescience North American
include regulations that have List of Subjects in 40 CFR Part 180 Corporation (perviously known as
‘‘substantial direct effects on the States, Arvesta Corporation) requested this
Environmental protection, tolerance under the Federal Food, Drug,
on the relationship between the national
Administrative practice and procedure, and Cosmetic Act (FFDCA), as amended
government and the States, or on the
Agricultural commodities, Pesticides by the Food Quality Protection Act of
distribution of power and
and pests, Reporting and recordkeeping 1996 (FQPA).
responsibilities among the various
requirements. DATES: This regulation is effective
levels of government.’’ This final rule
directly regulates growers, food Dated: September 15, 2005. September 23, 2005. Objections and
processors, food handlers and food James Jones, requests for hearings must be received
retailers, not States. This action does not Director, Office of Pesticide Programs.
on or before November 22, 2005.
alter the relationships or distribution of ADDRESSES: To submit a written
power and responsibilities established ■Therefore, 40 CFR chapter I is objection or hearing request follow the
by Congress in the preemption amended as follows: detailed instructions as provided in
provisions of section 408(n)(4) of Unit VI. of the SUPPLEMENTARY
FFDCA. For these same reasons, the PART 180—AMENDED INFORMATION. EPA has established a
Agency has determined that this rule docket for this action under Docket
does not have any ‘‘tribal implications’’ ■ 1. The authority citation for part 180 identification (ID) number OPP–2005–
as described in Executive Order 13175, continues to read as follows: 0185. All documents in the docket are
entitled Consultation and Coordination Authority: 21 U.S.C. 321(q), 346a and 371. listed in the EDOCKET index at http://
with Indian Tribal Governments (65 FR www.epa.gov/edocket. Although listed
67249, November 6, 2000). Executive ■ 2. Section 180.614 is added to read as in the index, some information is not
Order 13175, requires EPA to develop follows: publicly available, i.e., CBI or other
an accountable process to ensure § 180.614 Kasugamycin; tolerances for
information whose disclosure is
‘‘meaningful and timely input by tribal residues. restricted by statute. Certain other
officials in the development of material, such as copyrighted material,
regulatory policies that have tribal (a) General. Tolerances are is not placed on the Internet and will be
implications.’’ ‘‘Policies that have tribal established for residues of kasugamycin, publicly available only in hard copy
implications’’ is defined in the 3-O-[2-amino-4- form. Publicly available docket
Executive Order to include regulations [(carboxyiminomethyl)amino]-2,3,4,6- materials are available either
that have ‘‘substantial direct effects on tetradeoxy-a-D-arabino-hexopyranosyl]- electronically in EDOCKET or in hard
one or more Indian tribes, on the D-chiro-inositol in or on the following copy at the Public Information and
relationship between the Federal raw agricultural commodity: Records Integrity Branch (PIRIB), Rm.

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