Federal Register / Vol. 65, No. 86 / Wednesday, May 3, 2000 / Rules and Regulations 25655

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 FIFRA

section 18 petition under FFDCA

section 408, 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 FFDCA section 408(n)(4).

V. 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 25, 2000.

James Jones,

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.

§ 180.516 [Amended]

2. In § 180.516, by amending the table

in paragraph (b) by changing the date for

apricots, nectarines, peaches, and plums

from ‘‘12/31/99’’ to read ‘‘12/31/01’’.

[FR Doc. 00–11031 Filed 5–2–00; 8:45 am]

BILLING CODE 6560–50–F

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.

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: GilesParker.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:

Categories NAICS

codes

Examples of 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

25656 Federal Register / Vol. 65, No. 86 / Wednesday, May 3, 2000 / Rules and Regulations

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 KI 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-dioxo4-(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-oxido5-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

Federal Register / Vol. 65, No. 86 / Wednesday, May 3, 2000 / Rules and Regulations 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

25658 Federal Register / Vol. 65, No. 86 / Wednesday, May 3, 2000 / Rules and Regulations

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.

Federal Register / Vol. 65, No. 86 / Wednesday, May 3, 2000 / Rules and Regulations 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: 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).

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

25660 Federal Register / Vol. 65, No. 86 / Wednesday, May 3, 2000 / Rules and Regulations

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:

§ 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

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Part 180

[OPP–300984; FRL–6497–4]

RIN 2070–AB78

Harpin Protein; Exemption From the

Requirement of a Tolerance

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Final rule.

SUMMARY: This regulation establishes an

exemption from the requirement of a

tolerance for residues of the biochemical

pesticide harpin protein on all food

commodities when applied/used in

agricultural fields and greenhouses for

the management of plant diseases, the

significant improvement in growth and

yields, and the suppression of certain

insects and other pests. EDEN

Bioscience Corporation submitted a

petition to EPA under the Federal Food,

Drug, and Cosmetic Act, as amended by

the Food Quality Protection Act of 1996,

requesting an exemption from the

requirement of a tolerance. This

regulation eliminates the need to

establish a maximum permissible level

for residues of harpin protein.

DATES: This regulation is effective May

3, 2000. Objections and requests for

hearings, identified by docket control

number OPP–300984, must be received

by EPA, on or before July 3, 2000.

ADDRESSES: Written objections and

hearing requests may be submitted by

mail, electronically, or in person. Please

follow the detailed instructions for each

method as provided in Unit IX. of the

SUPPLEMENTARY INFORMATION. To ensure

proper receipt by EPA, your objections

and hearing requests must identify

docket control number OPP–300984 in

the subject line on the first page of your

response.

FOR FURTHER INFORMATION CONTACT: By

mail: Diana M. Horne, Biopesticides and

Pollution Prevention Division (7511C),

Environmental Protection Agency, Ariel

Rios Bldg., 1200 Pennsylvania Ave.,

NW., Washington, DC 20460; telephone

number: (703) 308–8367; and e-mail

address: horne.diana@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:

CategoriesNAICS

codes

Examples of 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