[Federal Register Volume 65, Number 86 (Wednesday, May 3, 2000)]
[Rules and Regulations]
[Pages 25655-25660]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-11030]


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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: <a href="/cdn-cgi/l/email-protection#3d7a5451584e106d5c4f56584f137e44534955545c7d584d5c505c545113584d5c135a524b"><span class="__cf_email__" data-cfemail="bcfbd5d0d9cf91ecddced7d9ce92ffc5d2c8d4d5ddfcd9ccddd1ddd5d092d9ccdd92dbd3ca">[email protected]</span></a>.

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 dose<INF>50</INF> 
(LD<INF>50</INF>) 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 
(DEEM<SUP>TM</SUP>). 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: 
<a href="/cdn-cgi/l/email-protection#c1a7b4b3adaeb6efa2a0adb7a8af81a4b1a0efa6aeb7"><span class="__cf_email__" data-cfemail="86e0f3f4eae9f1a8e5e7eaf0efe8c6e3f6e7a8e1e9f0">[email protected]</span></a>.

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 <a href="/cdn-cgi/l/email-protection#8cf8e3e1fce7e5e2ffa2e6e5e1cce9fceda2ebe3fa"><span class="__cf_email__" data-cfemail="c8bca7a5b8a3a1a6bbe6a2a1a588adb8a9e6afa7be">[email protected]</span></a>, 
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: <a href="/cdn-cgi/l/email-protection#1c736c6c3178737f7779685c796c7d327b736a"><span class="__cf_email__" data-cfemail="731c03035e171c10181607331603125d141c05">[email protected]</span></a>. 
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


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