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prohexadione-calcium Pesticide Tolerance 4/00

  


[Federal Register: May 3, 2000 (Volume 65, Number 86)]
[Rules and Regulations]
[Page 25655-25660]
>From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr03my00-15]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-300998; FRL-6555-2]
RIN 2070-AB78


Prohexadione Calcium; Pesticide Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes a tolerance for residues of
prohexadione calcium (calcium 3-oxido-5-oxo-4-propionylcyclohex-3-
enecarboxylate) in or on the raw agricultural commodities peanuts,
peanut hay, pome fruit group, kidney, and meat byproducts. K-I Chemical
U.S.A. Inc. requested this tolerance under the Federal Food, Drug, and
Cosmetic Act (FFDCA), as amended by the Food Quality Protection Act of
1996 (FQPA).

DATES: This regulation is effective May 3, 2000. Objections and
requests for hearings, identified by docket control number OPP-300998,
must be received by EPA on or before July 3, 2000.

ADDRESSES: Written objections and hearing requests may be submitted by
mail, in person, or by courier. Please follow the detailed instructions
for each method as provided in Unit VI. of the SUPPLEMENTARY
INFORMATION. To ensure proper receipt by EPA, your objections and
hearing requests must identify docket control number OPP-300998 in the
subject line on the first page of your response.

FOR FURTHER INFORMATION CONTACT: By mail: Cynthia Giles-Parker (PM 22),
Registration Division (7505C), Office of Pesticide Programs,
Environmental Protection Agency, Ariel Rios Bldg., 1200 Pennsylvania
Ave., NW.,Washington, DC 20460; telephone number: (703) 305-7740; and
e-mail address: Giles-Parker.Cynthia@epamail.epa.gov.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does This Action Apply to Me?

    You may be affected by this action if you are an agricultural
producer, food manufacturer, or pesticide manufacturer. Potentially
affected categories and entities may include, but are not limited to:

------------------------------------------------------------------------
                                                          Examples of
           Categories                 NAICS codes         potentially
                                                       affected entities
------------------------------------------------------------------------
Industry                          111                 Crop production.
                                  112                 Animal production.
                                  311                 Food
                                                       manufacturing.
                                  32532               Pesticide
                                                       manufacturing.
------------------------------------------------------------------------

    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 the table could also be
affected. The North American Industrial Classification System (NAICS)
codes have been provided to assist you and others in determining
whether or not this action might apply to certain entities. If you have
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 Additional Information, Including Copies of This
Document and Other Related Documents?

    1. Electronically. You may obtain electronic copies of this
document, and certain other related documents that might be available
electronically, from the EPA Internet Home Page at http://www.epa.gov/.
To access this document, on the Home Page select ``Laws and
Regulations'' and then look up the entry for this document under the
``Federal Register--Environmental Documents.'' You can also go directly
to

[[Page 25656]]

the Federal Register listings at http://www.epa.gov/fedrgstr/.
    2. In person. The Agency has established an official record for
this action under docket control number OPP-300998. The official record
consists of the documents specifically referenced in this action, and
other information related to this action, including any information
claimed as Confidential Business Information (CBI). This official
record includes the documents that are physically located in the
docket, as well as the documents that are referenced in those
documents. The public version of the official record does not include
any information claimed as CBI. The public version of the official
record, which includes printed, paper versions of any electronic
comments submitted during an applicable comment period is available for
inspection in the Public Information and Records Integrity Branch
(PIRIB), Rm. 119, Crystal Mall #2 (CM #2), 1921 Jefferson Davis Hwy.,
Arlington, VA, from 8:30 a.m. to 4 p.m., Monday through Friday,
excluding legal holidays. The PIRIB telephone number is (703) 305-5805.

II. Background and Statutory Findings

    In the Federal Register of August 5, 1998 (63 FR 41828) (FRL-5799-
6) and August 24, 1999 (64 FR 46191) (FRL-6069-6), EPA issued notices
pursuant to section 408 of FFDCA, 21 U.S.C. 346a as amended by FQPA
(Public Law 104-170) announcing the filing of a pesticide petition (PP
8F4941) for tolerance by K-I Chemical U.S.A. Inc., Westchester
Financial Center, 11 Martine Avenue, 9th Floor, White Plains, NY,
10606. These notices included a summary of the petition prepared by K-I
Chemical U.S.A. Inc., the registrant. There were no comments received
in response to the notices of filing.
    The petition requested that 40 CFR 180 be amended by establishing a
tolerance for residues of the plant growth regulator, prohexadione
calcium (cyclohexanecarboxylic acid, 3, 5-dioxo-4-(1-oxopropyl)-,
ion(1-), calcium, calcium salt) in or on the raw agricultural
commodities peanut nutmeat at 1.0, peanut hay at 0.6, pome fruit at
3.0, and cattle meat byproduct (kidney) at 0.1 parts per million (ppm).
EPA is editorially correcting the tolerance expressions to read
prohexadione calcium (calcium 3-oxido-5-oxo-4-propionylcyclohex-3-
enecarboxylate) in or on the raw agricultural commodities peanuts at
1.0 ppm, peanut hay at 0.6 ppm, pome fruit crop group at 3.0 ppm,
kidney of cattle, goats, hogs, horses, and sheep at 0.10 ppm and meat
byproducts except kidney of cattle, goats, hogs, horses and sheep at
0.05 ppm.
    Section 408(b)(2)(A)(i) of the FFDCA allows EPA to establish a
tolerance (the legal limit for a pesticide chemical residue in or on a
food) only if EPA determines that the tolerance is ``safe.'' Section
408(b)(2)(A)(ii) defines ``safe'' to mean that ``there is a reasonable
certainty that no harm will result from aggregate exposure to the
pesticide chemical residue, including all anticipated dietary exposures
and all other exposures for which there is reliable information.'' This
includes exposure through drinking water and in residential settings,
but does not include occupational exposure. Section 408(b)(2)(C)
requires EPA to give special consideration to exposure of infants and
children to the pesticide chemical residue in establishing a tolerance
and to ``ensure that there is a reasonable certainty that no harm will
result to infants and children from aggregate exposure to the pesticide
chemical residue. . . .''
    EPA performs a number of analyses to determine the risks from
aggregate exposure to pesticide residues. For further discussion of the
regulatory requirements of section 408 and a complete description of
the risk assessment process, see the final rule on Bifenthrin Pesticide
Tolerances (62 FR 62961, November 26, 1997) (FRL-5754-7).

III. Aggregate Risk Assessment and Determination of Safety

    Consistent with section 408(b)(2)(D), EPA has reviewed the
available scientific data and other relevant information in support of
this action. EPA has sufficient data to assess the hazards of and to
make a determination on aggregate exposure, consistent with section
408(b)(2), for a tolerance for residues of prohexadione calcium
(calcium 3-oxido-5-oxo-4-propionylcyclohex-3-enecarboxylate) in or on
the raw agricultural commodities peanuts at 1.0 ppm, peanut hay at 0.60
ppm, pome fruit group at 3.0 ppm, kidney of cattle, goats, hogs,
horses, and sheep at 0.10 ppm and meat byproducts except kidney of
cattle, goats, hogs, horses and sheep at 0.05 ppm. EPA's assessment of
the dietary exposures and risks associated with establishing the
tolerance follows.

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered its
validity, completeness, and reliability as well as the relationship of
the results of the studies to human risk. EPA has also considered
available information concerning the variability of the sensitivities
of major identifiable subgroups of consumers, including infants and
children. The nature of the toxic effects caused by prohexadione
calcium are discussed in this unit.
    1. A rat acute oral study with a lethal dose50
(LD50) greater than 5,000 milligrams (mg)/kilogram (kg) for
males and females. None of the acute toxicity studies showed
significant toxicity in the battery of tests (acute toxicity categories
III and IV for all routes of exposure).
    2. A 90-day rat feeding study with a No Observed Adverse Effect
Level (NOAEL) of: 73.1 mg/kg/day for males and 80.4 mg/kg/day for
females and a Lowest Observed Adverse Effect Level (LOAEL) of 734 mg/
kg/day for males and 815 mg/kg/day for females based on squamous cell
hyperplasia of the forestomach.
    3. A 90-day mouse feeding study with a NOAEL of equal to or greater
than 10,244 mg/kg/day for males and equal to or greater than 11,916 mg/
kg/day for females, highest dose tested (HDT).
    4. A 90-day dog dietary study with a NOAEL of 80 mg/kg/day and a
LOAEL of 400 mg/kg/day based on moderate cortical areas of dilated
basophilic tubules in the kidneys and decreased potassium levels.
    5. A 1-year dog chronic feeding study with a NOAEL of 20 mg/kg/day
and a LOAEL of 200 mg/kg/day based on histopathological changes in the
kidneys and increased urinary volume and sodium concentrations.
    6. A rat chronic feeding/carcinogenicity study with a NOAEL for
systemic toxicity of 93.9 mg/kg/day and a LOAEL of 469 mg/kg/day based
on decreased white blood cells (WBC) in males. There is no evidence of
carcinogenicity under conditions of the study.
    7. A mouse carcinogenicity study with a NOAEL for systemic toxicity
of 279 mg/kg/day and a LOAEL of 2,847 mg/kg/day based on decreased body
weight gain and food utilization and microscopic changes in the
stomachs of males. There was no evidence of carcinogenicity under
conditions of the study.
    8. A 2-generation rat reproduction study with a parental systemic
NOAEL of 35.5 mg/kg/day and parental systemic LOAEL of 385 mg/kg/day
based on increased mortality and a reproductive NOAEL equal to or
greater than 3,850 mg/kg/day (HDT) and an offspring NOAEL of 385 mg/kg/
day and an offspring LOAEL of 3,850 mg/kg/day based on decreased pup
body weight.
    9. A rat developmental study with a maternal and developmental
NOAEL

[[Page 25657]]

equal to or greater than 1,000 mg/kg/day (HDT).
    10. A rabbit developmental study with a maternal NOAEL of 40 mg/kg/
day and a maternal LOAEL of 200 mg/kg/day based on increased mortality,
abortions, and decreased maternal body weight gain and a developmental
NOAEL equal to or greater than 200 mg/kg/day (HDT). A second rabbit
developmental study with a maternal and developmental NOAEL equal to or
greater than 150 mg/kg/day (HDT). A third rabbit developmental study
with a maternal NOAEL of 100 mg/kg/day and a maternal LOAEL of 350 mg/
kg/day based on premature deliveries and a developmental NOAEL equal to
or greater than 350 mg/kg/day (HDT).
    11. A acute neurotoxicity screening battery with a NOAEL equal to
or greater than 2,000 mg/kg (HDT). A subchronic neurotoxicity screening
battery with a NOAEL equal to or greater than 1,148 mg/kg/day for males
and 1,348 mg/kg/day for females (HDT).
    12. Prohexadione calcium was negative for mutagenic/genotoxic
effects in a Bacterial reverse mutation assay (Ames test), an In vitro
mammalian gene mutation assay, an In vitro mammalian chromosome
aberration (Chinese hampster ovary (CHO) cells) study, an In vivo
mammalian chromosome aberration (rat bone marrow cells) study, a
Mammalian erythrocyte micronucleus test, an unscheduled DNA synthesis
(UDS) in primary rat hepatocytes study, and a Rec assay with Bacillus
subtilis study.
    13. Following oral treatment of rats, prohexadione calcium was
rapidly absorbed with highest tissue/carcass concentrations obtained
within 30 minutes; however, absorption became saturated at the highest
dose. The test material did not accumulate in the tissues. For low dose
animals, renal excretion was the primary route of elimination. At the
high dose, fecal excretion became the primary route of elimination. The
primary excreta metabolite was identified as the free acid.

B. Toxicological Endpoints

    1. Acute toxicity. EPA could not identify any toxicological effects
that could be attributable to a single oral exposure (dose) in any of
the available toxicological studies.
    2. Chronic toxicity. EPA has established the Chronic Reference Dose
(cRfD) for prohexadione calcium at 0.80 mg/kg/day. This cRfD is based
on both the subchronic and chronic toxicity studies in dogs. Since a
similar endpoint of equal severity (minimal and moderate dilation of
basophilic tubules) was observed in both studies, the results of the
two studies can be evaluated using a single dose-response curve. The
NOAEL of 80 mg/kg/day from the subchronic study due to the wider dose
spread than in the 1-year study and an uncertainty factor of 100 (10x
for interspecies extrapolation, 10x for intraspecies variability) were
used to establish the cRfD. The NOAEL of 80 mg/kg/day was based on
histopathological changes (dilated basophilic tubules) in the kidneys
and clinical chemical changes seen at the LOAEL of 200 mg/kg/day. No
additional uncertainty factor is needed because there is no increase in
the severity of the lesions over time in the chronic study as compared
to the subchronic study. Since an FQPA safety factor of 1x is
applicable for chronic dietary risk assessment, the chronic population
adjusted dose (cPAD) is equivalent to the cRfD of 0.80 mg/kg/day.
    3. Carcinogenicity. The Health Effects Division HIARC has
classified prohexadione calcium as ``not likely to be carcinogenic to
humans'' based on the lack of carcinogenicity in rats and mice.

C. Exposures and Risks

    1. From food and feed uses. No tolerances have been previously
established (40 CFR part 180) for the residues of prohexadione calcium,
in or on raw agricultural commodities. Risk assessments were conducted
by EPA to assess dietary exposures from prohexadione calcium as
follows:
    Chronic exposure and risk. The cPAD for prohexadione calcium is 0.8
mg/kg/day. A chronic dietary exposure analysis for prohexadione calcium
was performed using the Dietary Exposure Evaluation Model
(DEEMTM). Tolerance level residues were used and 100% crop
treated was assumed for all pome fruit and peanut commodities. The
chronic analysis was conducted for the U.S. population and all
population subgroups. The chronic exposure estimates (food only) for
the U.S. population and all population subgroups were less than 5% of
the cPAD.
    2. From drinking water. The estimated environmental concentration
(EEC) for ground water is 0.001 part per billion (ppb) (from screening
concentration in ground water (SCI-GROW) modeling). The EECs for
surface water (from generic expected environmental concentration
(GENEEC) modeling) are 36 ppb for the acute (peak) concentration and
2.6 ppb for the 56-day value (with 3x adjustment factor).
    3. From non-dietary exposure. There are no non-food uses of
prohexadione calcium currently registered under the Federal
Insecticide, Fungicide, and Rodenticide Act (FIFRA), as amended. No
non-dietary exposures are expected for the general population.
    4. Cumulative exposure to substances with a common mechanism of
toxicity. Section 408(b)(2)(D)(v) requires that, when considering
whether to establish, modify, or revoke a tolerance, the Agency
consider ``available information'' concerning the cumulative effects of
a particular pesticide's residues and ``other substances that have a
common mechanism of toxicity.''
    EPA does not have, at this time, available data to determine
whether prohexadione calcium has a common mechanism of toxicity with
other substances or how to include this pesticide in a cumulative risk
assessment. Unlike other pesticides for which EPA has followed a
cumulative risk approach based on a common mechanism of toxicity,
prohexadione calcium does not appear to produce a toxic metabolite
produced by other substances. For the purposes of this tolerance
action, therefore, EPA has not assumed that prohexadione calcium has a
common mechanism of toxicity with other substances. For information
regarding EPA's efforts to determine which chemicals have a common
mechanism of toxicity and to evaluate the cumulative effects of such
chemicals, see the final rule for Bifenthrin Pesticide Tolerances (62
FR 62961, November 26, 1997).

D. Aggregate Risks and Determination of Safety for U.S. Population

    1. Acute risk. EPA could not identify any toxicological effects
that could be attributable to a single oral exposure (dose) in any of
the available toxicological studies.
    2. Chronic risk. Using the DEEM chronic exposure assumptions
described in this unit, EPA has concluded that aggregate exposure from
food will utilize less than 1% of the cPAD for the U.S. population. The
major identifiable subgroup with the highest aggregate exposure is all
infants ( 1 year old) which utilizes 2.3% of the cPAD. EPA generally
has no concern for exposures below 100% of the cPAD because the cPAD
represents the level at or below which daily aggregate dietary exposure
over a lifetime will not pose appreciable risks to human health. The
drinking water level of comparisons (DWLOCs) for chronic exposure to
prohexadione calcium in drinking water calculated for the U.S.
population was 28,000 ppb, for females, 13-50 years old, was 24,000 ppb
and for all infants the DWLOC was 8,000 ppb. The EEC for

[[Page 25658]]

ground water is 0.001 ppb (from SCI-GROW modeling). The EEC for surface
water (from GENEEC modeling) is 2.6 ppb for the 56-day value (with 3x
adjustment factor). EPA's chronic DWLOC are well above the estimated
exposures for prohexadione calcium in water for the subgroups of
concern. Conservative model estimates (GENEEC and SCI-GROW) of the
concentrations of prohexadione calcium in surface and ground water
indicate that exposure will be minimal.
    3. Short- and intermediate-term risk. Short- and intermediate-term
aggregate risk assessments were not performed because there are no
residential uses proposed for prohexadione calcium.
    4. Determination of safety. Based on these risk assessments, EPA
concludes that there is a reasonable certainty that no harm will result
from aggregate exposure to prohexadione calcium residues.

E. Aggregate Risks and Determination of Safety for Infants and Children

    1. Safety factor for infants and children. In assessing the
potential for additional sensitivity of infants and children to
residues of prohexadione calcium, EPA considered data from
developmental toxicity studies in the rat and rabbit and a 2-generation
reproduction study in the rat. The developmental toxicity studies are
designed to evaluate adverse effects on the developing organism
resulting from maternal pesticide exposure gestation. Reproduction
studies provide information relating to effects from exposure to the
pesticide on the reproductive capability of mating animals and data on
systemic toxicity.
    FFDCA section 408 provides that EPA shall apply an additional
tenfold margin of safety for infants and children in the case of
threshold effects to account for prenatal and postnatal toxicity and
the completeness of the data base unless EPA determines that a
different margin of safety will be safe for infants and children.
Margins of safety are incorporated into EPA risk assessments either
directly through use of a margin of exposure (MOE) analysis or through
using uncertainty (safety) factors in calculating a dose level that
poses no appreciable risk to humans. EPA believes that reliable data
support using the standard uncertainty factor (usually 100 for combined
interspecies and intraspecies variability) and not the additional
tenfold MOE/uncertainty factor when EPA has a complete data base under
existing guidelines and when the severity of the effect in infants or
children or the potency or unusual toxic properties of a compound do
not raise concerns regarding the adequacy of the standard MOE/safety
factor.
    The prenatal and postnatal toxicology data base for prohexadione
calcium is adequate. The results of these studies indicated no
quantitative or qualitative increase in susceptibility of rats or
rabbits to in utero and/or postnatal exposure to prohexadione. No
developmental effects were seen at doses up to the limit dose (1,000
mg/kg/day) in the rat developmental toxicity study or up to the highest
doses tested (150, 200, and 350 mg/kg/day) in three rabbit
developmental toxicity studies. In the 2-generation reproduction study
in rats, the effects in the offspring were observed only at treatment
levels which resulted in evidence of parental toxicity.
    A developmental neurotoxicity (DNT) study is not required. No
neuropathology or central nervous system (CNS) malformations were seen
in the developmental toxicity studies. In the 2-generation reproduction
study in rats, there were no findings in pups that were suggestive of
changes in neurological development, although no functional assessment
was performed. Additionally, there was no evidence of neurotoxicity in
either the acute or subchronic neurotoxicity studies in rats and no
evidence of neurotoxicity in other studies.
    The Agency concluded that an extra safety factor to protect infants
and children is not needed based on the following considerations:
    i. The prenatal and postnatal toxicology data base is complete,
there is no indication of increased susceptibility, and a developmental
neurotoxicity study is not required.
    ii. The dietary (food and drinking water) exposure assessments will
not underestimate the potential exposures for infants and children from
the use of prohexadione calcium (currently there are no proposed
residential uses and, therefore, non-occupational exposure is not
expected).
    2. Determination of safety. Based on these risk assessments, EPA
concludes that there is a reasonable certainty that no harm will result
to infants and children from aggregate exposure to prohexadione calcium
residues.

IV. Other Considerations

A. Metabolism in Plants and Animals

    The nature of the residue in peanuts, pome fruit crop group, and
livestock is adequately understood. The residues of concern for the
tolerance expression are parent. Based on the results of animal
metabolism studies, tolerances established for kidney and meat
byproducts will cover any secondary residues that would occur in animal
commodities from the use on peanuts and pome fruits.

B. Analytical Enforcement Methodology

    Adequate enforcement methodology (gas chromatography and mass
selective detector) is available to enforce the tolerance expression.
The method may be requested from: Calvin Furlow, PRRIB, IRSD (7502C),
Office of Pesticide Programs, Environmental Protection Agency, Ariel
Rios Bldg., 1200 Pennsylvania Ave., NW., Washington, DC 20460;
telephone number: (703) 305-5229; e-mail address:
furlow.calvin@epa.gov.

C. Magnitude of Residues

    The qualitative nature of the residue of prohexadione calcium in
plants is adequately understood for the purpose of this petition. The
metabolism of prohexadione calcium in apples and peanuts is similar.
Prohexadione calcium is rapidly metabolized to prohexadione and parent-
like oxidative intermediates and ultimately to tricarballylic acid
(TCA), citric acid, and other natural products from the plant carbon
pool. Only the parent compound needs to be included in the tolerance
expression for pome fruit and peanuts and is the only compound to be
included in the dietary risk assessments.

D. International Residue Limits

    There are no Codex Alimentarius Commission (Codex), Canadian, or
Mexican Maximum Residue Levels (MRLs) for prohexadione calcium.

E. Rotational Crop Restrictions

    No tolerances for inadvertent residues of prohexadione calcium are
required in rotational crops at this time.

V. Conclusion

    Therefore, the tolerances are established for residues of
prohexadione calcium (calcium 3-oxido-5-oxo-4-propionylcyclohex-3-
enecarboxylate) in or on the raw agricultural commodities peanuts at
1.0 ppm, peanut hay at 0.60 ppm, pome fruit crop group at 3.0 ppm,
kidney of cattle, goats, hogs, horses, and sheep at 0.10 ppm, and meat
byproducts except kidney of cattle, goats, hogs, horses and sheep at
0.05 ppm.

VI. 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.

[[Page 25659]]

Although the procedures in those regulations require some modification
to reflect the amendments made to the FFDCA by the FQPA of 1996, EPA
will continue to use those procedures, with appropriate adjustments,
until the necessary modifications can be made. The new section 408(g)
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), as was provided in the old FFDCA
sections 408 and 409. However, the period for filing objections is now
60 days, rather than 30 days.

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

    You must file your objection or request a hearing on this
regulation in accordance with the instructions provided in this unit
and in 40 CFR part 178. To ensure proper receipt by EPA, you must
identify docket control number OPP-300998 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 3,
2000.
    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 (1900),
Environmental Protection Agency, Ariel Rios Bldg., 1200 Pennsylvania
Ave., NW., Washington, DC 20460. You may also deliver your request to
the Office of the Hearing Clerk in Rm. C400, Waterside Mall, 401 M St.,
SW., Washington, DC. The Office of the Hearing Clerk is open from 8
a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The
telephone number for the Office of the Hearing Clerk is (202) 260-4865.
    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, Ariel Rios Bldg., 1200 Pennsylvania Ave., NW.,
Washington, DC 20460.
    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, Ariel Rios Bldg.,
1200 Pennsylvania Ave., NW., Washington, DC 20460.
    3. Copies for the docket. In addition to filing an objection or
hearing request with the Hearing Clerk as described in Unit VI.A., you
should also send a copy of your request to the PIRIB for its inclusion
in the official record that is described in Unit I.B.2. Mail your
copies, identified by docket control number OPP-300998, to: Public
Information and Records Integrity Branch, Information Resources and
Services Division (7502C), Office of Pesticide Programs, Environmental
Protection Agency, Ariel Rios Bldg., 1200 Pennsylvania Ave., NW.,
Washington, DC 20460. In person or by courier, bring a copy to the
location of the PIRIB described in Unit I.B.2. You may also send an
electronic copy of your request via e-mail to: opp-docket@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).

VII. Regulatory Assessment Requirements

    This final rule establishes a tolerance under FFDCA section 408(d)
in response to a petition submitted to the Agency. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled Regulatory Planning and
Review (58 FR 51735, October 4, 1993). 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 prior consultation as specified by Executive Order
13084, entitled Consultation and Coordination with Indian Tribal
Governments (63 FR 27655, May 19, 1998); special considerations as
required by Executive Order 12898, entitled Federal Actions to Address
Environmental Justice in Minority Populations and Low-Income
Populations (59 FR 7629, February 16, 1994); or require OMB review or
any Agency action under Executive Order 13045, entitled Protection of
Children from Environmental Health Risks and Safety Risks (62 FR 19885,
April 23, 1997). This action does not involve any technical standards
that would require Agency consideration of voluntary consensus
standards pursuant to section 12(d) of the National Technology Transfer
and Advancement Act of 1995 (NTTAA), Public Law 104-113, section 12(d)
(15 U.S.C. 272 note). Since tolerances and exemptions that are
established on the basis of a petition under FFDCA section 408(d), such
as the tolerance in this final rule, do not require the issuance of a
proposed rule, the requirements of the Regulatory Flexibility Act (RFA)
(5 U.S.C. 601 et seq.) do not apply. In addition, the Agency has
determined that this action will not have a substantial direct effect
on States, on the relationship between the national government and the
States, or on the distribution of power and

[[Page 25660]]

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 FFDCA section 408(n)(4).

VIII. Submission to Congress and the Comptroller General

    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: April 26, 2000.
Susan B. Hazen,
Acting Director, 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), (346a) and 371.

    2. Section 180.547 is added to read as follows:

Sec. 180.547  Prohexadione calcium; tolerances for residues.

    (a) General. Tolerances are established for residues of the plant
growth regulator, prohexadione calcium (calcium 3-oxido-5-oxo-4-
propionylcyclohex-3-enecarboxylate) in or on the following raw
agricultural commodities:

------------------------------------------------------------------------
                 Commodity                       Parts per  million
------------------------------------------------------------------------
Cattle, kidney............................  0.10
Cattle, mbyp (except kidney)..............  0.05
Goats, kidney.............................  0.10
Goats, mbyp (except kidney)...............  0.05
Hogs, kidney..............................  0.10
Hogs, mbyp (except kidney)................  0.05
Horses, kidney............................  0.10
Horses, mbyp (except kidney)..............  0.05
Peanuts...................................  1.0
Peanut hay................................  0.60
Fruit, pome, group........................  3.0
Sheep, kidney.............................  0.10
Sheep, mbyp (except kidney)...............  0.05
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]

[FR Doc. 00-11030 Filed 5-2-00; 8:45 am]
BILLING CODE 6560-50-F