              OFFICE OF CHEMICAL SAFETY
AND POLLUTION PREVENTION
                 UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
                            WASHINGTON, D.C.  20460

MEMORANDUM

DATE:		August 22, 2012

SUBJECT:	Preliminary Human Health Assessment for the Registration Review of Cytokinins (as Kinetin) [Chemical Name, 1-H-Purin-6-amine, N-(2-furanylmethyl)-].

            Registration Review Case Number: 4107
            Chemical Class:	Biochemical
            PC Codes: 116801 and 116802
            CAS Number: 525-79-1
            Active Ingredient Tolerance Exemption: 40 CFR § 180.1157
            Type of Review: Human Health Assessment

FROM:		Colin G. Walsh, M.S., Biologist  /s/  08/22/2012
            Biochemical Pesticides Branch
            Biopesticides & Pollution Prevention Division (7511P)

TO:			Leonard Cole, Senior Regulatory Action Leader
            Biochemical Pesticides Branch
            Biopesticides & Pollution Prevention Division (7511P)

ACTION REQUESTED

The following scoping document contains the preliminary human health assessment for the biopesticide, cytokinins (as kinetin), in support of the development of the Registration Review Preliminary Work Plan.

Executive Summary

Based on the available data and information, the Agency does not foresee the need for new data or for new risk assessments for this active ingredient, cytokinins (as kinetin). Hazard and exposure information as well as Agency risk assessments on cytokinins (as kinetin) were evaluated against current safety standards established by the Agency's scientific policies and regulations and it was determined that there is no need to conduct additional risk assessments. The active ingredient is naturally occurring, has a non-toxic mode of action, is of low toxicity, and has very low use rates. There is reasonable certainty of no harm to the general population from exposure to this chemical in pesticide products when it is used according to label instructions.

I. Background

Cytokinin is comprised of the following four naturally occurring cytokinins derived from aqueous extract of seaweed meal: zeatin, N[6]-methylaminopurine, N[6]-dimethylaminopurine, and N[6]-isopentenylaminopurine (EPA, 1995). Kinetin [chemical name, 1-H-Purin-6-amine, N-(2-furanylmethyl)-] is a synthetic version of cytokinin and acts as a plant growth regulator (PGR) that is used to enhance the growth and development of plants. Cytokinins are used on growing crops, young trees, ornamentals, and golf courses to increase fruit size, yield, blossoms, branching, healthy appearance, and other desirable growth effects (EPA, 1995). Historically, the Agency has classified kinetin as a synthetic cytokinin; however, more recent data indicate that the chemical is naturally occurring in plants and animals (Barciszewski et al., 2000; EPA, 2001).

The active ingredient was first registered by the Agency in 1978. There are currently 50 registered products containing the active ingredient (PC Codes 118601 and 118602). Three of these products are manufacturing-use products (MPs); the remaining 47 are end-use products (EPs). Of the 47 EPs, 19 contain cytokinins (as kinetin) as the sole active ingredient; the remaining 28 contain the active ingredient along with another active ingredient(s). In general, cytokinins (as kinetin) are found in very low concentrations in EPs with the highest concentration at 1.11% (42 of 47 EPs at an a.i. concentration of less than 0.15%).

The chemical is currently not approved for use as an inert ingredient in pesticide products.

II. Tolerances

Cytokinins (specifically: aqueous extract of seaweed meal and kinetin) are exempt from the requirement of a tolerance under 40 CFR § 180.1157 in or on all food commodities when used as plant regulators on plants, seeds, or cuttings and on all food commodities after harvest in accordance with good agricultural practices. [64 FR 31505, June 11, 1999]

III. Incidents

According to the Incident Data System, there have been no reported incidents from the use of EPA-registered products that contain the active ingredient, cytokinins, between January 1, 1992 and August 15, 2012.

IV. Toxicity Profile

Sufficient data have been provided to fulfill the biochemical pesticide data requirements under 40 CFR § 158.2050 for the current use patterns for this active ingredient, cytokinins (as kinetin).  The data available to the Agency are summarized in Table 1 below.

Table 1: Human Health Assessment Data Requirements for Cytokinins (40 CFR § 158.2050)
                           Study/OCSPP Guideline No.
                                    Results
                         Toxicity Category/Description
                                     MRID
Acute oral toxicity (rat)
(870.1100)
           LD50 > 5,000 mg/kg body weight in male and female rats
                             Toxicity Category IV
                                   45453301
Acute dermal toxicity (rat)
(870.1200)
           LD50 > 5,000 mg/kg body weight in male and female rats
                             Toxicity Category IV
                                   45453302
Acute inhalation toxicity	 (rat)
(870.1300)
                  LC50 > 2.09 mg/L in male and female rats
                             Toxicity Category IV
                                   45453303
Primary eye irritation (rabbit)
(870.2400)
One hour after test substance instillation, all three treated eyes exhibited conjunctivitis and at 24 hours two eyes exhibited corneal opacity. The overall incidence and severity of irritation decreased with time. All animals were free of ocular irritation by 72 hours. Test substance is classified as mildly irritating to the eye.
                             Toxicity Category III
                                   45453304
Primary dermal irritation (rabbit)
(870.2500)
Animals did not exhibit any dermal irritation at any test site during the study. Test substance is classified as non-irritating to the skin.
                             Toxicity Category IV
                                   45453305
Dermal sensitization  (guinea pig)
(870.2600)
                  Test substance is not a dermal sensitizer.
                                       -
                                   45453306
90-Day oral toxicity
(870.3100)
The data requirement has been historically waived because of low acute mammalian toxicity and very low use rates which would not significantly increase dietary intake over natural consumption in foods. The historical information to support the data requirement is adequate.
                                       -
                                EPA RED (1995)
90-Day dermal toxicity
(870.3250)
The Agency has historically concluded that these occupational exposures and subsequent risks will be negligible because of the low acute mammalian toxicity and very low use rates. In addition, any unlikely dermal exposure will be mitigated on the label by precautionary statements and PPE requirements. The historical information to support the data requirement is adequate.
                                       -
                                EPA RED (1995)
90-Day inhalation toxicity
(870.3465)
The Agency has historically concluded that these occupational exposures and subsequent risks will be negligible because of the low acute mammalian toxicity and very low use rates. In addition, any unlikely inhalation exposure will be mitigated on the label by precautionary statements and PPE requirements. The historical information to support the data requirement is adequate.
                                       -
                                EPA RED (1995)
Developmental toxicity
 (870.3700)
The data requirement has been historically waived because of low acute mammalian toxicity and very low use rates which would not significantly increase dietary intake over natural consumption in foods. The historical information to support the data requirement is adequate.
                                       -
                                EPA RED (1995)
Mutagenicity
(870.5100, 5300 and 5375)
The data requirement has been historically waived because of low acute mammalian toxicity and very low use rates which would not significantly increase dietary intake over natural consumption in foods. The historical information to support the data requirement is adequate.
                                       -
                                EPA RED (1995)

V. References

Barciszewski, J, G. Siboska, SIS. Rattan. 2000. Occurrence, biosynthesis and properties of kinetin (N-6-furfuryladenine). Plant Growth Regulation. Vol. 32(2-3): 257-265.

EPA. 1995. Reregistration Eligibility Document (RED) for Cytokinin and R.E.D. Fact Sheet for Cytokinin, Kinetin, and N[6]-Benzyladenine. U.S. Environmental Protection Agency Office of Prevention, Pesticides and Toxic Substances. December 1995.
	http://www.epa.gov/oppsrrd1/REDs/4107.pdf
	http://www.epa.gov/pesticides/biopesticides/ingredients/factsheets/factsheet_116801.htm

EPA. 2001. Biopesticides Fact Sheet for Cytokinin. U.S. Environmental Protection Agency Office of Prevention, Pesticides and Toxic Substances. December 2001.
	http://www.epa.gov/opp00001/chem_search/reg_actions/registration/fs_G-29_01-Dec-01.pdf

cc: Colin G. Walsh, Leonard Cole, BPPD Science Review File, IHAD/ARS, Colin G. Walsh, FT, PY-S, August 22, 2012


[Federal Register Volume 80, Number 96 (Tuesday, May 19, 2015)]
[Notices]
[Pages 28621-28622]
[FR Doc No: 2015-12061]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0802]

Exploring Naloxone Uptake and Use; Public Meeting; Request for
Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public meeting; request for comments.

-----------------------------------------------------------------------

    The Food and Drug Administration (FDA), Center for Drug Evaluation
and Research, in collaboration with the National Institutes on Drug
Abuse, the Centers for Disease Control and Prevention, the Substance
Abuse and Mental Health Services Administration, and the Health
Resources and Services Administration, will hold a public meeting to
discuss increasing the use of naloxone to reduce the incidence of
opioid drug overdose fatalities. During the meeting, academic and
government experts, industry representatives, and patient advocates
will discuss which populations are at-risk for opioid drug overdose and
how we can work together to encourage the use of naloxone to reduce the
risk of overdose from opioid drugs.
    Date and Time: The public meeting will be held on July 1, 2015,
from 8 a.m. to 5 p.m. and on July 2, 2015, from 8 a.m. to 3 p.m. The
open public hearing will be held between 1 p.m. and 2 p.m. on July 1,
2015, and between 1 p.m. and 2 p.m. on July 2, 2015, during which
speaker testimony will be accepted. We will try to accommodate all
persons who wish to testify; however, the duration of each speaker's
testimony may be limited by time constraints. Those wishing to
participate in the open public hearing should limit their remarks to
issues related to the uptake of naloxone both in conventional medical
settings and outside of those settings to reduce the incidence of
opioid drug overdose fatalities.
    Location: The public meeting will be held at the FDA White Oak
Campus, 10903 New Hampshire Ave., Building 31 Conference Center, the
Great Room (Rm. 1503), Silver Spring, MD 20993-0002.
    Contact Person: Mary Gross, Center for Drug Evaluation and
Research, Food and Drug Administration, 10903 New Hampshire Ave.,
Silver Spring, MD 20993-0002,<PHONE_NUMBER><EMAIL_ADDRESS>or
Georgiann Ienzi, Center for Drug Evaluation and Research, Food and Drug
Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002,
301-796-3515<EMAIL_ADDRESS>    Registration: If you wish to attend the public meeting or provide
testimony during the open public hearing, please email your
registration to<EMAIL_ADDRESS>by June 22, 2015. Those
without email access may register by contacting one of the contact
persons (see Contact Persons). When registering, please provide
complete contact information for each attendee, including name, title,
affiliation, address, email address, and telephone number. Registration
is free and will be on a first-come, first-served basis. Early
registration is recommended because seating is limited. Registrants
will receive confirmation once they have been accepted for the public
meeting. Onsite registration on the day of the public meeting will be
permitted based on space availability. If registration reaches maximum
capacity, FDA will post a notice closing registration for the public
meeting at: http://www.fda.gov/Drugs/NewsEvents/ucm442236.htm.
    Comments: Submit either electronic or written comments by September
1, 2015. Submit electronic comments to http://www.regulations.gov.
Submit written comments to the Division of Dockets Management (HFA
305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852. It is only necessary to send one set of comments.
Identify comments with the docket number found in brackets in the
heading of this document. Received comments may be seen in the Division
of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday,
and will be posted to the docket at http://www.regulations.gov. If you
need special accommodations due to a disability, contact Mary Gross or
Georgiann Ienzi (see Contact Persons) at least 7 days in advance of the
meeting.

SUPPLEMENTARY INFORMATION:

I. Introduction

    The number of prescriptions filled for opioid drugs has increased
drastically in recent years. In 2009 nearly 257 million prescriptions
were written for opioid drugs in the United States. This number rose to
nearly 260 million in 2012. The increased availability of opioid drugs
appears to be contributing significantly to abuse and overdose in the
United States. In 2013 there were approximately 16,235 deaths from
overdose involving opioid drugs. That same year, there were 8,257
deaths from overdose involving heroin.
    Naloxone, a mu-opioid antagonist, is a medication that can rapidly
reverse the overdose of both prescription opioid

drugs (e.g., OxyContin) and illicit opioid drugs (e.g., heroin). It is
currently the standard treatment for those experiencing overdose and is
commonly used by trained medical personnel in emergency departments and
on ambulances. Its use among nonmedical personnel has also increased in
recent years. The purpose of the public meeting is to explore issues
surrounding the uptake of naloxone to treat opioid drug overdose. The
meeting agenda will include topics on the clinical, regulatory, and
legal implications of making naloxone more widely available. FDA will
post the agenda and additional public meeting material approximately 2
days before the workshop at: http://www.fda.gov/Drugs/NewsEvents/ucm442236.htm.

II. Transcripts

    A transcript will be made available approximately 45 days after the
public meeting. It will be accessible at http://www.regulations.gov and
may be viewed at the Division of Dockets Management (see Comments). A
transcript will also be available in either hardcopy or on CD-ROM,
after submission of a Freedom of Information request. Written requests
are to be sent to Division of Freedom of Information (ELEM-1029), Food
and Drug Administration, 12420 Parklawn Dr., Element Bldg., Rockville,
MD 20857.

    Dated: May 13, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-12061 Filed 5-18-15; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register: June 21, 2006 (Volume 71, Number 119)]
[Notices]
[Page 35717-35718]
[DOCID:fr21jn06-154]

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SECURITIES AND EXCHANGE COMMISSION

Existing Collection; Comment Request

Upon Written Request, Copies Available From: Securities and Exchange
Commission, Office of Filings and Information Services, Washington,
DC 20549.

Extension: Rule 17g-1; SEC File No. 270-208; OMB Control No. 3235-
0213.

    Notice is hereby given that, pursuant to the Paperwork Reduction
Act of 1995 (44 U.S.C. 3501-3520), the Securities and Exchange
Commission (the ``Commission'') is soliciting comments on the
collection of information summarized below. The Commission plans to
submit this existing collection of information to the Office of
Management and Budget for extension and approval.
    Rule 17g-1 (17 CFR 270.17g-1) under the Investment Company Act of
1940 (the ``Act'') (15 U.S.C. 80a-17(g)) governs the fidelity bonding
of officers and employees of registered management investment companies
(``funds'') and their advisers. Rule 17g-1 requires, in part, the
following:
     Independent Directors' Approval.
    The form and amount of the fidelity bond must be approved by a
majority of the fund's independent directors at least once annually,
and the amount of any premium paid by the fund for any ``joint insured
bond,'' covering multiple funds or certain affiliates, must be approved
by a majority of the fund's independent directors.
     Terms and Provisions of the Bond.
    The amount of the bond may not be less than the minimum amounts of
coverage set forth in a schedule based on the fund's gross assets; the
bond must provide that it shall not be cancelled, terminated, or
modified except upon 60-days written notice to the affected party and
to the Commission; in the case of a joint insured bond, 60-days written
notice must also be given to each fund covered by the bond; a joint
insured bond must provide that the fidelity insurance company will
provide all funds covered by the bond with a copy of the agreement, a
copy of any claim on the bond, and notification of the terms of the
settlement of any claim prior to execution of that settlement; and a
fund that is insured by a joint bond must enter into an agreement with
all other parties insured by the joint bond regarding recovery under
the bond.
     Filings with the Commission.
    Upon the execution of a fidelity bond or any amendment thereto, a
fund must file with the Commission within 10

days a copy of the executed bond or any amendment to the bond, the
independent directors' resolution approving the bond, and a statement
as to the period for which premiums have been paid on the bond. In the
case of a joint insured bond, a fund must also file (i) a statement
showing the amount the fund would have been required to maintain under
the rule if it were insured under a single insured bond and (ii) the
agreement between the fund and all other insured parties regarding
recovery under the bond. A fund must also notify the Commission in
writing within five days of any claim or settlement on a claim under
the fidelity bond.
     Notices to Directors.
    A fund must notify by registered mail each member of its board of
directors of (i) any cancellation, termination, or modification of the
fidelity bond at least 45 days prior to the effective date, and (ii)
the filing or settlement of any claim under the fidelity bond when
notification is filed with the Commission.
    Rule 17g-1's independent directors' annual review requirements,
fidelity bond content requirements, joint bond agreement requirement
and the required notices to directors seek to ensure the safety of fund
assets against losses due to the conduct of persons who may obtain
access to those assets. These requirements also seek to facilitate
oversight of a fund's fidelity bond. The rule's required filings with
the Commission are designed to assist the Commission in monitoring
funds' compliance with the fidelity bond requirements.
    The Commission staff estimates that approximately 4033 funds are
subject to the requirements of rule 17g-1, and that on average a fund
spends approximately one hour per year complying with the rule's
paperwork requirements. The Commission staff therefore estimates the
total annual burden of the rule's paperwork requirements to be 4033
hours.
    These estimates of average burden hours are made solely for the
purposes of the Paperwork Reduction Act. These estimates are not
derived from a comprehensive or even a representative survey or study
of Commission rules. The collection of information required by rule
17g-1 is mandatory and will not be kept confidential. An agency may not
conduct or sponsor, and a person is not required to respond to, a
collection of information unless it displays a currently valid control
number.
    Written comments are requested on: (a) Whether the collection of
information is necessary for the proper performance of the functions of
the Commission, including whether the information has practical
utility; (b) the accuracy of the Commission's estimate of the burden of
the collection of information; (c) ways to enhance the quality, utility
and clarity of the information collected; and (d) ways to minimize the
burden of the collection of information on respondents, including
through the use of automated collection techniques or other forms of
information technology. Consideration will be given to comments and
suggestions submitted in writing within 60 days of this publication.
    Please direct your written comments to R. Corey Booth, Director/
Chief Information Officer, Securities and Exchange Commission, C/O
Shirley Martinson, 6432 General Green Way, Alexandria, Virginia, 22312;
or send an e-mail to<EMAIL_ADDRESS>
    Dated: June 14, 2006.
Nancy M. Morris,
Secretary.
 [FR Doc. E6-9689 Filed 6-20-06; 8:45 am]

BILLING CODE 8010-01-P


OMB Control Number: 2060 0498 Pending Expiration Date: 6/ 30/ 06 U. S. Environmental Protection Agency STRATOSPHERIC OZONE PROTECTION PROGRAM CLASS II CONTROLLED SUBSTANCE REQUEST FOR ADDITIONAL CLASS II CONSUMPTION ALLOWANCES ( Sec 82.20)

SECTION 1 EXPORTING COMPANY IDENTIFICATION 1.1 Date of Submission 1.2 Number of Transactions Reported 1.3 Number of Pages Submitted NOTE: ATTACH ALL BILLS OF LADING AND INVOICES SHOWING NET QUANTITY SHIPPED AND DOCUMENTING THE SALE 1.4 Exporting Company Company Name Street Address City State Zip Code Exporter EIN from Customs Form 7525 1.5 Company Contact Identification Reporting Company Contact Person Phone Number Fax Number E mail Address 1.6 Signature of Reporting Company Representative I certify under penalty of law that I have personally examined and am familiar with the information submitted in this and all attached documents, and that based on my inquiry of those individuals immediately responsible for obtaining the information, I believe that the submitted information is true, accurate, and complete. I am aware that there are significant penalties for submitting false information, including the possibility of fine and imprisonment.

Name Title Signature Date SEND COMPLETED FORMS TO: For U. S. Postal Service:

Tracking System Program Manager Stratospheric Protection Division U. S. EPA ( 6205J) 1200 Pennsylvania Avenue, NW Washington, DC 20460 For Private Courier:

Tracking System Program Manager Stratospheric Protection Division U. S. EPA ( 6205J) 1310 L Street, NW, 8th Floor Washington, DC 20005 The public reporting and recordkeeping burden for this collection of information is estimated to average 4.5 hours per response. Send comments on the Agency's need for this information, the accuracy of the provided burden estimates, and any suggested methods for minimizing respondent burden, including through the use of automated collection techniques to the Director, Collection Strategies Division, U. S. Environmental Protection Agency ( 2822T), 1200 Pennsylvania Ave., NW, Washington, D. C. 20460. Include the OMB control number in any correspondence. Do not send the completed form to this address.

Pending EPA ICR NUMBER 2014.03, Revised 4/ 06 OMB Control Number: 2060 0498 Pending Expiration Date: 6/ 30/ 06 U. S. Environmental Protection Agency STRATOSPHERIC OZONE PROTECTION PROGRAM CLASS II CONTROLLED SUBSTANCE REQUEST FOR ADDITIONAL CLASS II CONSUMPTION ALLOWANCES ( Sec 82.20)

SECTION 2 TRANSACTION RECORDS ( Reproduce additional sheets as needed) 2.1 Company Name 2.2 Transaction Summaries TRANSACTION #

Recipient Company Name Street Address City Country Postal Code Company Contact Person Phone Number Fax Number Quantity of Commodity Exported ( kg)

HCFC Chemical Exported Quantity of HCFC Exported ( kg)

Date of Export ( mm/ dd/ yy) Port of Export from the U. S.

Company that produced the HCFC with production and consumption allowances Select One: Country from which the HCFCs were imported and company that expended consumption allowances Date Purchased TRANSACTION #

Recipient Company Name Street Address City Country Postal Code Company Contact Person Phone Number Fax Number Quantity of Commodity Exported ( kg)

HCFC Chemical Exported Quantity of HCFC Exported ( kg)

Date of Export ( mm/ dd/ yy) Port of Export from the U. S.

Company that produced the HCFC with production and consumption allowances Select One: Country from which the HCFCs were imported and company that expended consumption allowances Date Purchased TRANSACTION #

Recipient Company Name Street Address City Country Postal Code Company Contact Person Phone Number Fax Number Quantity of Commodity Exported ( kg)

HCFC Chemical Exported Quantity of HCFC Exported ( kg)

Date of Export ( mm/ dd/ yy) Port of Export from the U. S.

Company that produced the HCFC with production and consumption allowances Select One: Country from which the HCFCs were imported and company that expended consumption allowances Date Purchased Pending EPA ICR NUMBER 2014.03, Revised 4/ 06 OMB Control Number: 2060 0498 Pending Expiration Date: 6/ 30/ 06 Pending EPA ICR NUMBER 2014.03, Revised 4/ 06 U. S. Environmental Protection Agency STRATOSPHERIC OZONE PROTECTION PROGRAM CLASS II CONTROLLED SUBSTANCE REQUEST FOR ADDITIONAL CLASS II CONSUMPTION ALLOWANCES ( Sec 82.20)

SECTION 3 COMPANY EXPORT TOTALS 3.1 Company Name 3.2 Company Request Summary A B Chemical Name ( Commodity Code) Total Consumption Allowances Requested ( kg)

HCFC 22 ( 2903.49.9010)

HCFC 141b ( 2903.49.0000)

HCFC 142b ( 2903.49.0000)


37759 Federal Register / Vol. 68, No. 122 / Wednesday, June 25, 2003 / Rules and Regulations proposed rule, the requirements of the Regulatory Flexibility Act ( RFA) ( 5 U. S. C. 601 et seq.) do not apply. In addition, the Agency has determined that this action will not have a substantial direct effect on States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132, entitled Federalism ( 64 FR 43255, August 10, 1999). Executive Order 13132 requires EPA to develop an accountable process to ensure `` meaningful and timely input by State and local officials in the development of regulatory policies that have federalism implications.'' `` Policies that have federalism implications'' is defined in the Executive order to include regulations that have `` substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.'' This final rule directly regulates growers, food processors, food handlers and food retailers, not States. This action does not alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of section 408( n)( 4) of the FFDCA. For these same reasons, the Agency has determined that this rule does not have any `` tribal implications'' as described in Executive Order 13175, entitled Consultation and Coordination with Indian Tribal Governments ( 65 FR 67249, November 6, 2000). Executive Order 13175, requires EPA to develop an accountable process to ensure `` meaningful and timely input by tribal officials in the development of regulatory policies that have tribal implications.'' `` Policies that have tribal implications'' is defined in the Executive order to include regulations that have `` substantial direct effects on one or more Indian tribes, on the relationship between the Federal Government and the Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes.'' This rule will not have substantial direct effects on tribal governments, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes, as specified in Executive Order 13175. Thus, Executive Order 13175 does not apply to this rule. IX. Congressional Review Act The Congressional Review Act, 5 U. S. C. 801 et seq., as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the 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 record keeping requirements.

Dated: June 12, 2003. Peter Caulkins, Acting Director, Registration Division, Office of Pesticide Programs.

 Therefore, 40 CFR chapter I is amended as follows:

PART 180   [ AMENDED]

 1. The authority citation for part 180 continues to read as follows:

Authority: 21 U. S. C. 321( q), 346( a) and 371.

 2. Section 180.527 is amended by revising paragraphs ( a) and ( d) to read as follows:

§ 180.527 N( 4 fluorophenyl) N( 1 methylethyl) 2[( 5( trifluoromethyl) 1,3,4 thiadiazol 2 yl) oxy] acetamide; tolerances for residues.

( a) General. Tolerances are established for the combined residues of the herbicide N( 4 fluorophenyl) N( 1 methylethyl) 2[( 5( trifluoromethyl) 1,3,4 thiadiazol 2 yl) oxy] acetamide and its metabolites containing the 4 fluoro N methylethyl benzenamine moiety in or on the following raw agricultural commodities:

Commodity Parts per million Corn, field, forage 0.4 Corn, field, grain ... 0.05 Corn, field, stove .. 0.4 Soybean, seed ...... 0.1 * * * * * ( d) Indirect or inadvertent residues. Tolerances are established for indirect or inadvertent residues of the herbicide N( 4 fluroophenyl) N( 1 methylethyl) 2 [( 5( trifluoromethyl) 1,3,4 thiadiazol 2 yl) oxy] acetamide and its metabolites containing the 4 fluoro N methylethyl benzenamine moiety in or on the raw agricultural commodities listed in paragraph ( a) of this section.

Commodity Parts per million Alfalfa, forage ....... 0.1 Alfalfa, hay ............ 0.1 Alfalfa, seed .......... 0.1 Clover, forage ....... 0.1 Clover, hay ........... 0.1 Grain, cereal, group 15, except rice .................... 0.1 Grain, cereal, forage fodder, and straw, group 16, except rice ......... 0.1 Grass, forage, fodder and hay, group 17 ............ 0.1 [ FR Doc. 03   15905 Filed 6   24   03; 8: 45 am]

BILLING CODE 6560   50   S ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [ OPP   2003   0179; FRL   7311   5]

Extension of Tolerances for Emergency Exemptions ( Multiple Chemicals)

AGENCY: Environmental Protection Agency ( EPA). ACTION: Final rule.

SUMMARY: This regulation extends timelimited tolerances for the pesticides listed in Unit II. of the SUPPLEMENTARY INFORMATION. These actions are in response to EPA's granting of emergency exemptions under section 18 of the Federal Insecticide, Fungicide, and Rodenticide Act ( FIFRA) authorizing use of these pesticides. Section 408( l)( 6) of the Federal Food, Drug, and Cosmetic Act ( FFDCA) requires EPA to establish a time limited tolerance or exemption from the requirement for a tolerance for pesticide chemical residues in food that will result from the use of a pesticide under an emergency exemption granted by EPA. DATES: This regulation is effective June 25, 2003. Objections and requests for hearings, identified by docket ID number OPP   2003   0179, must be received by EPA on or before July 25, 2003. ADDRESSES: Written objections and hearing requests may be submitted electronically, by mail, or through hand VerDate Jan< 31> 2003 15: 29 Jun 24, 2003 Jkt 200001 PO 00000 Frm 00067 Fmt 4700 Sfmt 4700 E:\ FR\ FM\ 25JNR1. SGM 25JNR1 37760 Federal Register / Vol. 68, No. 122 / Wednesday, June 25, 2003 / Rules and Regulations delivery/ courier. Follow the detailed instructions as provided in Unit I. of the SUPPLEMENTARY INFORMATION. FOR FURTHER INFORMATION CONTACT: See the table in this unit for the name of a specific contact person. The following information applies to all contact persons: Emergency Response Team, Registration Division ( 7505C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460   0001.

Pesticide/ CFR cite Contact person Maneb; § 180.110 Desmedipham; § 180.353 Hydramethylnon; § 180.395 Propiconazole; § 180.434 Libby Pemberton Sec 18 Mailbox@ epamail. epa. gov Phone number ( 703) 308   9364 Terbacil; § 180.209 Myclobutanil; § 180.443 Carfentrazone ethyl; § 180.515 Methoxyfenozide; § 180.544 Barbara Madden Sec 18 Mailbox@ epamail. epa. gov Phone number ( 703) 305   6463 Fludioxonil; § 180.516 Andrew Ertman Sec 18 Mailbox@ epamail. epa. gov Phone number ( 703) 308   9367 Tebuconazole; § 180.474 Difenoconazole; § 180.475 Fenbuconazole; § 180.480 Pyriproxyfen; § 180.510 Tetraconazole; § 180.557 Andrea Conrath Sec 18 Mailbox@ epamail. epa. gov Phone number ( 703) 308   9356 SUPPLEMENTARY INFORMATION:

I. General Information A. Does this Action Apply to Me?

You may be potentially affected by this action if you are a Federal or State Government Agency involved in administration of environmental quality programs ( i. e., Departments of Agriculture, Environment, etc). Potentially affected entities may include, but are not limited to:   Federal or State Government Entity, ( NAICS 9241), i. e., Departments of Agriculture, Environment, etc. This listing is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be affected by this action. Other types of entities not listed in this unit could also be affected. The North American Industrial Classification System ( NAICS) codes have been provided to assist you and others in determining whether this action might apply to certain entities. If you have any questions regarding the applicability of this action to a particular entity, consult the person listed under FOR FURTHER INFORMATION CONTACT.

B. How Can I Get Copies Of this Document and Other Related Information?

1. Docket. EPA has established an official public docket for this action under docket identification ID number OPP   2003   0179. The official public docket consists of the documents specifically referenced in this action, any public comments received, and other information related to this action. Although a part of the official docket, the public docket does not include Confidential Business Information ( CBI) or other information whose disclosure is restricted by statute. The official public docket is the collection of materials that is available for public viewing at the Public Information and Records Integrity Branch ( PIRIB), Rm. 119, Crystal Mall # 2, 1921 Jefferson Davis Hwy., 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. 2. Electronic access. 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 http:// www. access. gpo. gov/ nara/ cfr/ cfrhtml_ 00/ Title_ 40/ 40cfr180_ 00. html, a beta site currently under development. An electronic version of the public docket is available through EPA's electronic public docket and comment system, EPA Dockets. You may use EPA Dockets at http:// www. epa. gov/ edocket/ to submit or view public comments, access the index listing of the contents of the official public docket, and to access those documents in the public docket that are available electronically. Although not all docket materials may be available electronically, you may still access any of the publicly available docket materials through the docket facility identified in Unit I. B. 1. Once in the system, select `` search,'' then key in the appropriate docket ID number.

II. Background and Statutory Findings EPA published a final rule in the Federal Register for each chemical/ commodity listed below. The initial issuance of these final rules announced that EPA, on its own initiative, under section 408 of the FFDCA, 21 U. S. C. 346a, as amended by the Food Quality Protection Act of 1996 ( FQPA) ( Public Law 104   170) was establishing timelimited tolerances. EPA established the tolerances because section 408( l)( 6) of the FFDCA requires EPA to establish a time limited tolerance or exemption from the requirement for a tolerance for pesticide chemical residues in food that will result from the use of a pesticide under an emergency exemption granted by EPA under FIFRA section 18. Such tolerances can be established without providing notice or time for public comment. EPA received requests to extend the use of these chemicals for this year's growing season. After having reviewed these submissions, EPA concurs that emergency conditions exist. EPA assessed the potential risks presented by residues for each chemical/ commodity. In doing so, EPA considered the safety standard in section 408( b)( 2) of the FFDCA, and decided that the necessary tolerance under section 408( l)( 6) of the FFDCA would be consistent with the safety standard and with FIFRA section 18.

VerDate Jan< 31> 2003 15: 29 Jun 24, 2003 Jkt 200001 PO 00000 Frm 00068 Fmt 4700 Sfmt 4700 E:\ FR\ FM\ 25JNR1. SGM 25JNR1 37761 Federal Register / Vol. 68, No. 122 / Wednesday, June 25, 2003 / Rules and Regulations The data and other relevant material were evaluated and discussed in the final rule originally published to support these uses. Based on that data and information considered, the Agency reaffirms that extension of these timelimited tolerances will continue to meet the requirements of section 408( l)( 6) of the FFDCA. Therefore, the time limited tolerances are extended until the date listed. EPA will publish a document in the Federal Register to remove the revoked tolerances from the Code of Federal Regulations ( CFR). Although these tolerances will expire and are revoked on the date listed, under section 408( l)( 5) of the FFDCA, residues of the pesticide not in excess of the amounts specified in the tolerance remaining in or on the commodity after that date will not be unlawful, provided the residue is present as a result of an application or use of a pesticide at a time and in a manner that was lawful under FIFRA, the tolerance was in place at the time of the application, and the residue does not exceed the level that was authorized by the tolerance. EPA will take action to revoke these tolerances earlier if any experience with, scientific data on, or other relevant information on this pesticide indicate that the residues are not safe. Tolerances for the use of the following pesticide chemicals on specific commodities are being extended: 1. Carfentrazone ethyl. EPA has authorized under FIFRA section 18 the use of carfentrazone ethyl on hops for control of hops sucker growth to indirectly control powdery mildew in Idaho, Oregon, and Washington. This regulation extends a time limited tolerance for combined residues of the herbicide carfentrazone ethyl, ( ethyl a 2 dichloro 5[ 4( difluoromethyl) 4,5 dihydro 3 methyl 5 oxo 1H 1,2,4 triazol 1 yl] 4 fluorobenzenepropanoate) and its metabolite carfentrazonechloropropionic acid ( a, 2 dichloro 5[ 4 ( difluoromethyl) 4,5 dihydro 3 methyl 5 oxo 1H 1,2,4 triazol 1 yl] 4 fluorobenzenepropanoic acid) in or on hop, dried cone at 0.30 ppm for an additional 2   year period. This tolerance will expire and is revoked on June 30, 2005. A time limited tolerance was originally published in the Federal Registerof August 1, 2001 ( 66 FR 39640) ( FRL   6792   2) 2. Desmedipham. EPA has authorized under FIFRA section 18 the use of desmidipham on garden beets for control of various weed pests in New York. This regulation extends a timelimited tolerance for residues of the herbicide desmedipham in or on red beet roots at 0.2 ppm and red beet tops at 15 ppm for an additional 18   month period. These tolerances will expire and are revoked on June 30, 2005. Timelimited tolerances were originally published in the Federal Register on August 29, 1997 ( 62 FR 45741) ( FRL   5738   5). 3. Difenoconazole. EPA has authorized under FIFRA section 18 the use of difenoconazole on sweet corn seed for control of damping off and dieback diseases in Idaho and Colorado. This regulation extends time limited tolerances for residues of the fungicide difenoconazole ( 1(( 2( 2 chloro 4( 4 chlorophenoxy) phenyl) 4 methyl 1,3 dioxolan 2 yl) methyl) 1H 1,2,4 triazole) in or on corn, sweet ( kernel + corn with husk removed); corn, sweet, forage; and corn, sweet, stover at 0.1 ppm for an additional 2   year period. These tolerances will expire and are revoked on December 31, 2005. The time limited tolerances were originally published in the Federal Register of September 1, 1999 ( 64 FR 47680) ( FRL   6094   3). 4. Fenbuconazole. EPA has authorized under FIFRA section 18 the use of fenbuconazole on grapefruit for control of greasy spot disease in Florida. This regulation extends time limited tolerances for combined residues of the fungicide fenbuconazole, ( a[ 2 4 chlorophenyl) ethyl] a phenyl 3( 1H 1,2,4 triazole) 1 propanenitrile] and its metabolites cis 5( 4 chlorophenyl) dihydro 3 phenyl 3( 1H 1,2,4 triazole 1 ylmethyl) 2 3H furanone and trans 5( 4 chlorophenyl) dihydro 3 phenyl 3 ( 1H1,2,4 triazole 1 ylmethyl 2 3Hfuranone in or on fat, meat, and meat byproducts of cattle, goats, hogs, horses, and sheep at 0.01 ppm; grapefruit at 0.5 ppm; grapefruit oil at 35 ppm; and grapefruit dried pulp at 4 ppm for an additional 2   year period. These tolerances will expire and are revoked on December 31, 2005. The time limited tolerances were originally published in the Federal Register of January 29, 1999 ( 64 FR 4577) ( FRL   6054   3). 5. Fludioxonil. EPA has authorized under FIFRA section 18 the use of fludioxonil on pomegranates for control of gray mold in California. This regulation extends a time limited tolerance for combined residues of the fungicide fludioxonil, 4( 2,2 difluoro 1,3 benzodioxol 4 yl) 1H pyrrole 3 carbonitrile), in or on pomegranates at 5.0 ppm for an addtionional 3   year period. This tolerance will expire and is revoked on June 30, 2006. The timelimited tolerance was originally published in the Federal Register of September 12, 2001 ( 66 FR 47403) ( FRL   6797   5). 6. Hydramethylnon. EPA has authorized under FIFRA section 18 the use of hydramethylnon on pineapple for control of big headed and Argentine ants in Hawaii. This regulation extends a time limited tolerance for residues of the insecticide hydramethylnon; tetrahydro 5,5 dimethyl 2( 1H) pyrimidinoine ( 3( 4 trifluoromethyl) phenyl) 1[ 2 [ 4( trifluoromethyl) phenyl] ethenyl) 2 propenylidene) hydrazone] in or on pineapple at 0.05 ppm for an additional 2   year period. This tolerance will expire and is revoked on June 30, 2005. A time limited tolerance was originally published in the Federal Register of March 4, 1998 ( 63 FR 10537) ( FR   5767   1). 7. Maneb. EPA has authorized under FIFRA section 18 the use of maneb on walnuts for control of bacterial blight in California. This regulation extends a time limited tolerance for combined residues of the fungicide maneb ( manganous ethylenebisdithiocarbamate) calculated as zinc ethylenebisdithiocarbamate, and its metabolite ethylenethiourea in or on walnuts at 0.05 ppm for an additional 2   year period. This tolerance will expire and is revoked on December 31, 2005. A time limited tolerance was originally published in the Federal Register of March 17, 1999 ( 64 FR 13097) ( FRL   6067   9) 8. Methoxyfenozide. EPA has authorized under FIFRA section 18 the use of methoxyfenozide on soybeans for control of soybean loopers and salt marsh catepillars in Mississippi. This regulation extends a time limited tolerance for residues of the insecticide methoxyfenozide, benzoic acid, 3 methoxy 2 methyl 2( 3,5 dimethylbenzoyl) 2( 1,1 dimethylethyl) hydrazide in or on soybean aspirated grain fractions at 20 ppm, soybean seed at 0.04 ppm, soybean forage at 10 ppm, soybean hay at 75 ppm and soybean oil at 1.0 ppm for an additional 2   year period. These tolerances will expire and are revoked on December 31, 2005. A time limited tolerance was originally published in the Federal Register of November 2, 2001 ( 66 FR 55585) ( FRL   6806   4) 9. Myclobutanil. EPA has authorized under FIFRA section 18 the use of myclobutanil on hops for control of powdery mildew in Idaho, Oregon, and Washington. This regulation extends a time limited tolerance for combined residues of the fungicide myclobutanil, a butyl a( 4 chlorophenyl) 1H 1,2,4 triazole 1 propanenitrile and its alcohol metabolite a( 3 hydroxybutyl) a( 4 chlorophenyl) 1H 1,2,4 triazole 1 propanenitrile ( free and bound) in or on hops at 5.0 ppm for an additional 2   year period. This tolerance will expire and is revoked on December 31, 2005. A time

VerDate Jan< 31> 2003 15: 29 Jun 24, 2003 Jkt 200001 PO 00000 Frm 00069 Fmt 4700 Sfmt 4700 E:\ FR\ FM\ 25JNR1. SGM 25JNR1 37762 Federal Register / Vol. 68, No. 122 / Wednesday, June 25, 2003 / Rules and Regulations limited tolerance was originally published in the Federal Register of July 10, 1998 ( 63 FR 37289) ( FRL   5798   6). 10. Myclobutanil. EPA has authorized under FIFRA section 18 the use of myclobutanil on peppers for control of powdery mildew in California. This regulation extends a time limited tolerance for combined residues of the fungicide myclobutanil a butyl a( 4 chlorophenyl) 1H 1,2,4 triazole 1 propanenitrile and its alcohol metabolite ( a( 3 hydroxybutyl) a( 4 chlorophenyl) 1H 1,2,4 triazole 1 propanenitrile ( free and bound) in or on pepper at 1.0 ppm for an additional 2   year period. This tolerance will expire and is revoked on June 30, 2005. A timelimited tolerance was originally published in the Federal Register of September 16, 1998 ( 63 FR 49472) ( FRL   6025   1). 11. Propiconazole. EPA has authorized under FIFRA section 18 the use of propiconazole on dry beans for control of rust in Colorado, Kansas, Minnesota, Nebraska, and North Dakota. This regulation extends a time limited tolerances for combined residues of the fungicide propiconazole 1[[ 2( 2,4 dichlorophenyl) 4 propyl 1,3 dioxolan 2 yl] methyl] 1H 1,2,4 triazole and its metabolite determined as 2,4 dichlorobenzoic acid in or on dry beans at 0.5 ppm, dry bean forage at 8 ppm, and dry bean hay at 8 ppm for an additional 2   year period. These tolerances will expire and are revoked on December 31, 2005. The time limited tolerances for dry bean commodities were originally published in the Federal Register of June 13, 1997 ( 62 FR 32224) ( FRL   5718   8). 12. Propiconazole. EPA has authorized under FIFRA section 18 the use of propiconazole on cranberry for control of cottonball disease in Wisconsin. This regulation extends a time limited tolerance for combined residues of the fungicide propiconazole, 1[[ 2( 2,4 dichlorophenyl) 4 propyl 1,3 dioxolan 2 yl] methyl] 1H 1,2,4 triazole and its metabolites determined as 2,4 dichlorobenzoic acid and expressed as parent compound in or on cranberry at 1.0 ppm for an additional 2   year period. This tolerance will expire and is revoked on December 31, 2005. A timelimited tolerance was originally published in the Federal Register of April 11, 1997 ( 62 FR 17710) ( FRL   5600   5). 13. Propiconazole. EPA has authorized under FIFRA section 18 the use of propiconazole on grain sorghum for control of sorghum ergot in Kansas, New Mexico and Texas. This regulation extends a time limited tolerance for combined residues of the fungicide propiconazole, 1[[ 2( 2,4 dichlorophenyl) 4 propyl 1,3 dioxolan 2 yl] methyl] 1H 1,2,4 triazole and its metabolites determined as 2,4 dichlorobenzoic acid and expressed as parent compound in or on grain sorghum, grain at 0.2 ppm; grain sorghum, stover at 1.5 ppm; and sorghum aspirated grain fractions at 20 ppm for an additional 18   month period. These tolerances will expire and are revoked on June 30, 2005. Time limited tolerances were originally published in the Federal Register of August 13, 1997 ( 62 FR 43284) ( FRL   5735   2) EPA has received objections to tolerances it established for propiconazole on different food commodities. The objections were filed by the Natural Resources Defense Council ( NRDC) and raised several issues regarding aggregate exposure estimates and the additional safety factor for the protection of infants and children. Although these objections concern separate rulemaking proceedings under the FFDCA, EPA has considered whether it is appropriate to extend the emergency exemption tolerances for propiconazole while the objections are still pending. Factors taken into account by EPA included how close the Agency is to concluding the proceedings on the objections, the nature of the current action, whether NRDC's objections raised frivolous issues, and extent to which the issues raised by NRDC had already been considered by EPA. Although NRDC's objections are not frivolous, the other factors all support extending these tolerances at this time. First, the objections proceeding is unlikely to conclude prior to when action is necessary on this petition. NRDC's objections raise complex legal, scientific, policy, and factual matters and EPA initiated a 60 day public comment period on them in the Federal Register of June 19, 2002 ( 67 FR 41628) ( FRL   7167   7). That comment period was extended until October 16, 2002 ( September 17, 2002 ( 67 FR 58536) ( FRL   7275   3)), and EPA is now examining the extensive comments received. Second, the nature of the current actions are extremely timesensitive as they address emergency situations. Third, the issues raised by NRDC are not new matters but questions that have been the subject of considerable study by EPA and comment by stakeholders. Accordingly, EPA is proceeding with extending the tolerances for propiconazole. 14. Pyriproxyfen. EPA has authorized under FIFRA section 18 the use of pyriproxyfen on beans for control of whiteflies in Florida. This regulation extends a time limited tolerance for residues of the insecticide pyriproxyfen, 2[ 1 methyl 2( 4 phenoxyphenoxy) ethoxypyridine in or on bean, succulent at 0.1 ppm for an additional 2   year period. This tolerance will expire and is revoked on June 30, 2005. A time limited tolerance was originally published in the Federal Register of September 5, 2001 ( 66 FR 46390) ( FRL   6798   6). 15. Tebuconazole. EPA has authorized under FIFRA section 18 the use of tebuconazole on garlic for control of rust in California. This regulation extends a time limited tolerance for residues of the fungicide tebuconazole, ( a[ 2( 4 chlorophenyl) ethyl] a( 1,1 dimethylethyl) 1H 1,2,4 triazole 1 ethanol) in or on garlic at 0.1 ppm for an additional 2   year period. This tolerance will expire and is revoked on December 31, 2005. A time limited tolerance was originally published in the Federal Register of May 26, 1999 ( 64 FR 28377) ( FRL   6079   1). 16. Tebuconazole. EPA has authorized under FIFRA section 18 the use of tebuconazole on wheat for control of fusarium head blight in Michigan, Minnesota, North Dakota, and South Dakota. This regulation extends a timelimited tolerance for residues of the fungicide tebuconazole ( a[ 2( 4 chlorophenyl) ethyl] a( 1,1 dimethylethyl) 1H 1,2,4 triazole 1 ethanol) in or on wheat hay at 15.0 ppm and wheat straw at 2.0 ppm for an additional 18   month period. These tolerances will expire and are revoked on June 30, 2005. Time limited tolerances were originally published in the Federal Register of June 20, 1997 ( 62 FR 33550) ( FRL   5725   7). 17. Tebuconazole. EPA has authorized under FIFRA section 18 the use of tebuconazole on barley for control of fusarium head blight in Minnesota, North Dakota, and South Dakota. This regulation extends timelimited tolerances for residues of the fungicide tebuconazole ( a[ 2( 4 chlorophenyl) ethyl] a( 1,1 dimethylethyl) 1H 1,2,4 triazole 1 ethanol) in or on barley grain at 2.0 ppm, barley hay at 20.0 ppm, and barley straw at 20.0 ppm for an additional 18   month period. These tolerances will expire and are revoked on June 30, 2005. Time limited tolerance were originally published in the Federal Register of June 20, 1997 ( 62 FR 33550) ( FRL   5725   7). 18. Terbacil. EPA has authorized under FIFRA section 18 the use of terbacil on watermelon for control of morningglory and other annual broadleaf weeds in Virginia. This VerDate Jan< 31> 2003 15: 29 Jun 24, 2003 Jkt 200001 PO 00000 Frm 00070 Fmt 4700 Sfmt 4700 E:\ FR\ FM\ 25JNR1. SGM 25JNR1 37763 Federal Register / Vol. 68, No. 122 / Wednesday, June 25, 2003 / Rules and Regulations regulation extends a time limited tolerance for combined residues of the herbicide terbacil ( 3 tert Butyl 5 chloro 6 methyluracil and its three metabolites 3 tert butyl 5 chloro 6 hydroxymethyluracil, 6 chloro 2,3 dihydro 7 hydroxymethyl 3,3 dimethyl 5H oxazolo ( 3,2 a) pyrimidin 5 one, and 6 chloro 2,3 dihydro 3,3,7 trimethyl 5H oxazolo ( 3,2 a) pyrimidin 5 one) which are calculated as terbacil in or on watermelon at 4.0 ppm for an additional 2   year period. This tolerance will expire and is revoked on June 30, 2005. A time limited tolerance was originally published in the Federal Register of June 20, 1997 ( 62 FR 33557) ( FRL   5718   7) 19. Tetraconazole. EPA has authorized under FIFRA section 18 the use of tetraconazole on sugar beets for control of cercospora leaf spot in Colorado, Montana, Nebraska, and Wyoming. This regulation extends timelimited tolerances for residues of the fungicide tetraconazole, [(+/) 2( 2,4 dichlorophenyl) 3( 1H 1,2,4 triazol 1 yl) propyl 1, 1,2,2 tetrafluoroethyl ether] in or on sugarbeets, and sugarbeet related commodities, and for secondary residues of triazole on animal commodities from livestock fed sugarbeet by products] at 0.10 part per million in/ on sugarbeet, 6.0 ppm in/ on sugarbeet top, 0.20 ppm in/ on sugarbeet dried pulp, 0.30 ppm in/ on sugarbeet molasses, 0.050 ppm in milk, 0.030 ppm in cattle, meat and meat byproducts except kidney and liver, 0.20 ppm in kidney, 6.0 ppm in liver, and 0.60 ppm in fat for an additional 2   year period. These tolerances will expire and are revoked on December 31, 2005. The time limited tolerances were originally published in the Federal Register of December 6, 1999 ( 64 FR 68046) ( FRL   6384   1).

III. Objections and Hearing Requests Under section 408( g) of the FFDCA, as amended by the FQPA, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. The EPA procedural regulations which govern the submission of objections and requests for hearings appear in 40 CFR part 178. Although the procedures in those regulations require some modification to reflect the amendments made to the FFDCA by the FQPA, EPA will continue to use those procedures, with appropriate adjustments, until the necessary modifications can be made. The new section 408( g) of the FFDCA provides essentially the same process for persons to `` object'' to a regulation for an exemption from the requirement of a tolerance issued by EPA under new section 408( d) of the FFDCA, as was provided in the old sections 408 and 409 of the FFDCA. However, the period for filing objections is now 60 days, rather than 30 days.

A. What Do I Need to Do to File an Objection or Request a Hearing? You must file your objection or request a hearing on this regulation in accordance with the instruction provided in this unit and in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number OPP   2003   0179 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 July 25, 2003. 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 issues( s) on which a hearing is requested, the requestor's contentions on such issues, and a summary of any evidence relied upon by the objector ( 40 CFR 178.27). Information submitted in connection with an objection or hearing request may be claimed confidential by marking any part or all of that information as CBI. Information so marked will not be disclosed except in accordance with procedures set forth in 40 CFR part 2. A copy of the information that does not contain CBI must be submitted for inclusion in the public record. Information not marked confidential may be disclosed publicly by EPA without prior notice. Mail your written request to: Office of the Hearing Clerk ( 1900C), 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 Rm. 104, Crystal Mall # 2, 1921 Jefferson Davis Hwy., Arlington, VA. 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 ( 703) 603   0061. 2. Tolerance fee payment. If you file an objection or request a hearing, you must also pay the fee prescribed by 40 CFR 180.33( i) or request a waiver of that fee pursuant to 40 CFR 180.33( m). You must mail the fee to: EPA Headquarters Accounting Operations Branch, Office of Pesticide Programs, P. O. Box 360277M, Pittsburgh, PA 15251. Please identify the fee submission by labeling it `` Tolerance Petition Fees.'' EPA is authorized to waive any fee requirement `` when in the judgement of the Administrator such a waiver or refund is equitable and not contrary to the purpose of this subsection.'' For additional information regarding the waiver of these fees, you may contact James Tompkins by phone at ( 703) 305   5697, by e mail at tompkins. jim@ epa. gov, or by mailing a request for information to Mr. Tompkins at Registration Division ( 7505C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460   0001. If you would like to request a waiver of the tolerance objection fees, you must mail your request for such a waiver to: James Hollins, Information Resources and Services Division ( 7502C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460   0001. 3. Copies for the Docket. In addition to filing an objection or hearing request with the Hearing Clerk as described in Unit III. A., you should also send a copy of your request to the PIRIB for its inclusion in the official record that is described in Unit I. B. 1. Mail your copies, identified by docket ID number OPP   2003   0179, to: Public Information and Records Integrity Branch, Information Resources and Services Division ( 7502C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460   0001. In person or by courier, bring a copy to the location of the PIRIB described in Unit I. B. 1. You may also send an electronic copy of your request via e mail to: oppdocket epa. gov. 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 file format or ASCII file format. Do not include any CBI in your electronic copy. You may also submit an electronic copy of your request at many Federal Depository Libraries.

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

VerDate Jan< 31> 2003 15: 29 Jun 24, 2003 Jkt 200001 PO 00000 Frm 00071 Fmt 4700 Sfmt 4700 E:\ FR\ FM\ 25JNR1. SGM 25JNR1 37764 Federal Register / Vol. 68, No. 122 / Wednesday, June 25, 2003 / Rules and Regulations IV. Statutory and Executive Order Reviews This final rule establishes timelimited tolerances under section 408 of the FFDCA. The Office of Management and Budget ( OMB) has exempted these types of actions from review under Executive Order 12866, entitled Regulatory Planning and Review ( 58 FR 51735, October 4, 1993). Because this rule has been exempted from review under Executive Order 12866 due to its lack of significance, this rule is not subject to Executive Order 13211, Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use ( 66 FR 28355, May 22, 2001). This final rule does not contain any information collections subject to OMB approval under the Paperwork Reduction Act ( PRA), 44 U. S. C. 3501 et seq., or impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act of 1995 ( UMRA) ( Public Law 104   4). Nor does it require any special considerations under Executive Order 12898, entitled Federal Actions to Address Environmental Justice in Minority Populations and Low Income Populations ( 59 FR 7629, February 16, 1994); or OMB review or any Agency action under Executive Order 13045, entitledProtection 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 under section 408( l)( 6) of the FFDCA in response to an exemption under FIFRA section 18, such as the tolerances in this final rule, do not require the issuance of a proposed rule, the requirements of the Regulatory Flexibility Act ( RFA) ( 5 U. S. C. 601 et seq.) do not apply. In addition, the Agency has determined that this action will not have a substantial direct effect on States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132, entitled Federalism ( 64 FR 43255, August 10, 1999). Executive Order 13132 requires EPA to develop an accountable process to ensure `` meaningful and timely input by State and local officials in the development of regulatory policies that have federalism implications. `` Policies that have federalism implications'' is defined in the Executive Order to include regulations that have `` substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.'' This final rule directly regulates growers, food processors, food handlers and food retailers, not States. This action does not alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of section 408( n)( 4) of the FFDCA. For these same reasons, the Agency has determined that this rule does not have any `` tribal implications'' as described in Executive Order 13175, entitledConsultation 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.

V. Congressional Review Act The Congressional Review Act, 5 U. S. C. 801 et seq., as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the 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: June 16, 2003. Debra Edwards, Director, Registration Division, Office of Pesticide Programs.

 Therefore, 40 CFR chapter I is amended as follows:

PART 180   [ AMENDED]

 1. The authority citation for part 180 continues to read as follows:

Authority: 21 U. S. C. 321( q), 346( a) and 371.

§ 180.110 [ Amended]

 2. In § 180.110, in the table to paragraph ( b), amend the entry for walnut by revising the expiration/ revocation date `` 12/ 31/ 03'' to read `` 12/ 31/ 05.''

§ 180.209 [ Amended]

 3. In § 180.209, in the table to paragraph ( b), amend the entry for watermelon by revising the expiration/ revocation date `` 6/ 30/ 03'' to read `` 6/ 30/ 05.''

§ 180.353 [ Amended]

 4. In § 180.353, in the table to paragraph ( b), amend the entry for red beet roots and red beet tops by revising the expiration/ revocation date `` 12/ 31/ 03'' to read `` 6/ 30/ 05.''

§ 180.395 [ Amended]

 5. In § 180.395, in the table to paragraph ( b), amend the entry for pineapple by revising the expiration/ revocation date `` 6/ 30/ 03'' to read `` 6/ 30/ 05.''

§ 180.434 [ Amended]

 6. In § 180.434, in the table to paragraph ( b), amend the entries for sorghum, aspirated grain fractions; sorghum, grain, grain; and sorghum, grain, stover by revising the expiration/ revocation date `` 12/ 31/ 03'' to read `` 6/ 30/ 05'' and amend the entries for cranberry; dry bean; dry bean forage; and dry bean hay by revising the expiration/ revocation date `` 12/ 31/ 03'' to read `` 12/ 31/ 05.''

§ 180.443 [ Amended]

 7. In § 180.443, in the table to paragraph ( b), amend the entries for pepper by revising the expiration/ revocation date `` 6/ 30/ 03'' to read `` 6/ 30/ 05'' and for hop, dried cone by revising the expiration/ revocation date `` 12/ 31/ 03'' to read `` 12/ 31/ 05.''

VerDate Jan< 31> 2003 15: 29 Jun 24, 2003 Jkt 200001 PO 00000 Frm 00072 Fmt 4700 Sfmt 4700 E:\ FR\ FM\ 25JNR1. SGM 25JNR1 37765 Federal Register / Vol. 68, No. 122 / Wednesday, June 25, 2003 / Rules and Regulations § 180.474 [ Amended]

 8. In § 180.474, in the table to paragraph ( b), amend the entries for barley, grain; barley, hay; barley, straw; wheat, hay; and wheat, straw by revising the expiration/ revocation date `` 12/ 31/ 03'' to read `` 6/ 30/ 05'' and amend the entry for garlic by revising the expiration/ revocation date `` 12/ 31/ 03'' to read. `` 12/ 31/ 05''

§ 180.475 [ Amended]

 9. In § 180.475, in the table to paragraph ( b), amend the entry for corn, sweet, kernel plus cob with husks removed; corn, sweet, forage; and, corn, sweet, stover by revising the expiration/ revocation date `` 12/ 31/ 03'' to read `` 12/ 31/ 05.''

§ 180.480 [ Amended]

 10. In § 180.480, in the table to paragraph ( b), amend the entries for cattle, fat; cattle, meat byproducts; cattle, meat; goat, fat; goat, meat byproducts; goat, meat; grapefruit; grapefruit, dried pulp; grapefruit, oil; hog, fat; hog, meat byproducts; hog, meat; horse, fat; horse, meat byproducts; horse, meat; sheep, fat; sheep, meat byproducts; sheep, meat by revising the expiration/ revocation date `` 12/ 31/ 03'' to read. `` 12/ 31/ 05.''

§ 180.510 [ Amended]

 11. In § 180.510, in the table to paragraph ( b), amend the entry for bean, succulent by revising the expiration/ revocation date `` 6/ 30/ 03'' to read `` 6/ 30/ 05.''

§ 180.515 [ Amended]

 12. In § 180.515, in the table to paragraph ( b), amend the entry for hop, dried cone by revising the expiration/ revocation date `` 6/ 30/ 03'' to read `` 6/ 30/ 05.''

§ 180.516 [ Amended]

 12. In § 180.516, in the table to paragraph ( b), amend the entry for pomegrante by revising the expiration/ revocation date `` 6/ 30/ 03'' to read `` 6/ 30/ 06.''

§ 180.544 [ Amended]

 13. In § 180.544, in the table to paragraph ( b), amend the entries for soybean, aspirated grain fractions; soybean, forage; soybean, hay; soybean, refined oil; soybean, seed by revising the expiration/ revocation date `` 12/ 31/ 03'' to read `` 12/ 31/ 05.''

§ 180.557 [ Amended]

 14. In § 180.515, in the table to paragraph ( b), amend the entries for beet, sugar, dried pulp; beet, sugar, molasses; beet, sugar, roots; beet, sugar, tops; cattle, fat; cattle, kidney; cattle, liver; cattle, meat; cattle, meat byproducts, except kidney and liver; and milk by revising the expiration/ revocation date `` 12/ 31/ 03'' to read `` 12/ 31/ 05.'' [ FR Doc. 03   15906 Filed 6   24   03; 8: 45 am]

BILLING CODE 6560   50   S ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [ OPP   2003   0136; FRL   7310   7]

Buprofezin; Pesticide Tolerance AGENCY: Environmental Protection Agency ( EPA). ACTION: Final rule.

SUMMARY: This regulation establishes tolerances for residues of buprofezin in or on bean, snap, succulent; logan; lychee; pistachio; pulasan; rambutan;, and spanish lime. Interregional Research Project Number 4 ( IR 4) requested these tolerances 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 June 25, 2003. Objections and requests for hearings, identified by docket ID number OPP   2003   0136, must be received on or before August 25, 2003. ADDRESSES: Written objections and hearing requests may be submitted electronically, by mail, or through hand delivery/ courier. Follow the detailed instructions as provided in Unit VI. of the SUPPLEMENTARY INFORMATION. FOR FURTHER INFORMATION CONTACT: By mail: Shaja R. Brothers, Registration Division ( 7050C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460   0001; telephone number: ( 703) 308   3194; e mail address: brothers. shaja@ epa. gov@ epa. gov. 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, and pesticide manufacturer. Potentially affected entities may include, but are not limited to:   Crop production ( NAICS 111)   Animal production ( NAICS 112)   Food manufacturing ( NAICS 311)   Pesticide manufacturing ( NAICS 32532) This listing is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be affected by this action. Other types of entities not listed in this unit could also be affected. The North American Industrial Classification System ( NAICS) codes have been provided to assist you and others in determining whether this action might apply to certain entities. If you have any questions regarding the applicability of this action to a particular entity, consult the person listed under FOR FURTHER INFORMATION CONTACT.

B. How Can I Get Copies of this Document and Other Related Information? 1. Docket. EPA has established an official public docket for this action under docket identification ID number OPP   2003   0136. The official public docket consists of the documents specifically referenced in this action, any public comments received, and other information related to this action. Although a part of the official docket, the public docket does not include Confidential Business Information ( CBI) or other information whose disclosure is restricted by statute. The official public docket is the collection of materials that is available for public viewing at the Public Information and Records Integrity Branch ( PIRIB), Rm. 119, Crystal Mall # 2, 1921 Jefferson Davis Hwy., 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. 2. Electronic access. 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 http:// www. access. gpo. gov/ nara/ cfr/ cfrhtml_ 00/ Title_ 40/ 40cfr180_ 00. html, a beta site currently under development. An electronic version of the public docket is available through EPA's electronic public docket and comment system, EPA Dockets. You may use EPA Dockets at http:// www. epa. gov/ edocket/ to submit or view public comments, access the index listing of the contents of the official public docket, and to access those documents in the public docket that are available electronically. Although not all docket materials may be available electronically, you may still access any of the publicly available docket materials through the docket facility identified in Unit I. B. 1. Once in the system, select `` search,'' then key in the appropriate docket ID number.

II. Background and Statutory Findings In the Federal Register of March 26, 2003 ( 68 FR 14619) ( FRL   7295   8), EPA issued a notice pursuant to section 408 VerDate Jan< 31> 2003 15: 29 Jun 24, 2003 Jkt 200001 PO 00000 Frm 00073 Fmt 4700 Sfmt 4700 E:\ FR\ FM\ 25JNR1. SGM 25JNR1