Federal Register / Vol. 65, No. 86 / Wednesday, May 3, 2000 / Rules and Regulations 25647

Taking of Private Property

This rule will not effect a taking of

private property or otherwise have

taking implications under E.O. 12630,

Governmental Actions and Interference

with Constitutionally Protected Property

Rights.

Civil Justice Reform

This rule meets applicable standards

in sections 3(a) and 3(b)(2) of E.O.

12988, Civil Justice Reform, to minimize

litigation, eliminate ambiguity, and

reduce burden.

Protection of Children

We have analyzed this rule under E.O.

13045, Protection of Children from

Environmental Health Risks and Safety

Risks. This rule is not an economically

significant rule and does not concern an

environmental risk to health or risk to

safety that may disproportionately affect

children.

Environment

The Coast Guard considered the

environmental impact of this rule and

concluded that under figure 2–1,

paragraph (32)(e), of Commandant

Instruction M16475.lC, this rule is

categorically excluded from further

environmental documentation. A

‘‘Categorical Exclusion Determination’’

is available in the docket for inspection

or copying where indicated under

ADDRESSES.

List of Subjects in 33 CFR Part 117

Bridges

Temporary Regulations.

For the reasons discussed in the

preamble, the Coast Guard amends 33

CFR part 117 as follows:

PART 117—[AMENDED]

1. The authority citation for part 117

continues to read as follows:

Authority: 33 U.S.C. 499; 49 CFR 1.46; 33

CFR 1.05–1(g); section 117.255 also issued

under the authority of Pub. L. 102–587, 106

Stat. 5039.

2. From 7:25 a.m. through 8:15 a.m.

on May 21, 2000, in § 117.261,

paragraphs (u) and (v) are suspended

and new paragraphs (rr) and (ss) are

added to read as follows:

§ 117.261 Atlantic Intracoastal Waterway

from St. Marys River to Key Largo.

* * * * *

(rr) Flagler Memorial (SR A1A) bridge,

mile 1021.9 at Palm Beach. The draw

shall open on signal; except that, from

7:25 a.m. to 7:45 a.m. on May 21, 2000,

the draw need not open.

(ss) Royal Park (SR 704) bridge, mile

1022.6 at Palm Beach. The draw shall

open on signal; except that, from 7:25

a.m. to 8:15 a.m. on May 21, 2000, the

draw need not open.

Dated: April 18, 2000.

T.W. Allen

Rear Admiral, U.S. Coast Guard, Commander,

Seventh Coast Guard District.

[FR Doc. 00–10943 Filed 5–2–00; 8:45 am]

BILLING CODE 4910–15–U

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Part 180

[OPP–300989; FRL–6550–9]

RIN 2070–AB78

Pyridate; Pesticide Tolerance

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Final rule.

SUMMARY: This regulation establishes

tolerances for combined residues of

pyridate in or on peppermint tops,

spearmint tops, Brassica, head and stem

subgroup, and collards. The

Interregional Research Project Number 4

and Novartis Crop Protection, Inc.,

requested these tolerances under the

Federal Food, Drug, and Cosmetic Act,

as amended by the Food Quality

Protection Act of 1996.

DATES: This regulation is effective May

3, 2000. Objections and requests for

hearings, identified by docket control

number OPP–300989, 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–300989 in

the subject line on the first page of your

response.

FOR FURTHER INFORMATION CONTACT: By

mail: Shaja R. Brothers, Registration

Division (7505C), Office of Pesticide

Programs, Environmental Protection

Agency, Ariel Rios Bldg., 1200

Pennsylvania Ave., NW., Washington,

DC 20460; telephone number: (703)

308–3194; and e-mail address:

brothers.shaja@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

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

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–300989. 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

25648 Federal Register / Vol. 65, No. 86 / Wednesday, May 3, 2000 / Rules and Regulations

and Records Integrity Branch (PIRIB),

Rm. 119, Crystal Mall #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 January 24,

2000 (65 FR 3682) (FRL–6399–6), and

August 5, 1998 (63 FR 41835) (FRL–

6017–1), EPA issued notices pursuant to

section 408 of the Federal Food, Drug,

and Cosmetic Act (FFDCA), 21 U.S.C.

346a as amended by the Food Quality

Protection Act of 1996 (FQPA) (Public

Law 104–170) announcing the filing of

pesticide petitions (PP) 9E6025 and

6F4754 for tolerances by the

Interregional Research Project Number

4, New Jersey Agricultural Experiment

Station, Rutgers University, New

Brunswick, NJ 08903, and Novartis Crop

Protection Inc., 18300 Greensboro, NC

27419–8300, respectively. These notices

included a summary of petitions

prepared by Novartis Crop Protection

Inc., the registrant. There were no

comments received in response to the

notice of filing.

These petitions requested that 40 CFR

180.462 be amended by establishing

tolerances for combined residues of the

herbicide pyridate, [O-(6-chloro-3-

phenyl-4-pyridazinyl)-S-octylcarbonothioate and the metabolite CL–

9673 (6-chloro-3-phenyl-pyradazine-4-

ol), and conjugates of CL–9673], in or on

peppermint tops and spearmint tops at

0.20, Brassica, head and stem subgroup,

and collards at 0.03 parts per million

(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 tolerances for

combined residues of pyridate on

peppermint tops and spearmint tops at

0.20 ppm, Brassica, head and stem

subgroup, and collards at 0.03 ppm.

EPA’s assessment of the dietary

exposures and risks associated with

establishing the tolerances 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 pyridate are

discussed in Unit II.A. of the Final Rule

on Pyridate Pesticide Tolerance

published in the Federal Register on

October 7, 1998 (63 FR 53837) (FRL

6036–2).

B. Toxicological Endpoints

1. Acute toxicity. The acute dietary

endpoint selected for the acute dietary

risk assessment was 20 milligrams/

kilogram/day (mg/kg/day) based on the

subchronic (90–day) dog study with a

no observed adverse effect level

(NOAEL) of 20 mg/kg/day. The lowest

observed adverse effect level (LOAEL)

was 60 mg/kg/day based on ataxia and

emesis observed within 1–3 hours of

dosing beginning on the first day. An

uncertainty factor of 100 (10X for

interspecies extrapolation and 10X for

intraspecies variations) was used to

determine the acute Reference Dose

(RfD) of 0.2 mg/kg/day. The acute

Population Adjusted Dose (aPAD) is

equal to the acute RfD divided by the

FQPA Safety Factor. Since the FQPA

Safety Factor was reduced to 1X, the

aPAD is equal to the acute RfD.

2.Chronic toxicity. EPA has

established the chronic RfD for pyridate

at 0.11 mg/kg/day. This RfD is based on

a NOAEL of 10.8 mg/kg/day from the

chronic/carcinogenicity study in rats

where decreased body weight gain was

reported at the LOAEL of 67.5 mg/kg/

day. This dose was supported by the

results of the 3-generation reproduction

toxicity study. The NOAEL was 10.8

mg/kg/day based on the reported

decrease in pup weights at 67.5 mg/kg/

day on postnatal day 14 and 21 in both

generations. An uncertainty factor of

100 (10X for interspecies extrapolation

and 10X for intraspecies variation) was

used to determine the chronic Reference

Dose (cRfD) of 0.11 mg/kg/day. The

chronic Population Adjusted Dose

(cPAD) is equal to the chronic RfD

divided by the FQPA Safety Factor.

Since the FQPA Safety Factor was

reduced to 1X, the cPAD is equal to the

chronic RfD.

3. Carcinogenicity. Pyridate is not

carcinogenic in either the rat or the

mouse. Therefore, no carcinogenic

endpoint was selected.

C. Exposures and Risks

1. From food and feed uses.

Tolerances have been established (40

CFR 180.462) for the combined residues

of pyridate, in or on a variety of raw

agricultural commodities. Permanent

tolerances are established for combined

residues of pyridate, the metabolite CL–

9673, and conjugates of CL–9673 in/on

cabbage, corn, and peanut at 0.03 ppm.

Risk assessments were conducted by

EPA to assess dietary exposures from

pyridate as follows:

i. Acute exposure and risk. Acute

dietary risk assessments are performed

for a food-use pesticide if a toxicological

study has indicated the possibility of an

effect of concern occurring as a result of

a 1–day or single exposure. Tier 1 acute

dietary exposure analyses from food for

pyridate were performed with the

Dietary Exposure Evaluation Model

(DEEMTM) using published and

proposed tolerance level residues and

100% crop treated (CT) for all

commodities. Therefore, the acute risk

was analyzed at the 95th percentile. The

acute dietary risk estimates from food

are less than 1% of the aPAD for the

general U.S. population and all

population subgroups. The results of the

analyses indicate that the acute dietary

risks from food associated with the

existing and proposed uses of pyridate

do not exceed EPA’s level of concern for

the U.S. population or any population

subgroup.

ii. Chronic exposure and risk. Tier 1

chronic dietary exposure analyses from

food for pyridate were performed with

the DEEMTM using published and

proposed tolerance level residues and

Federal Register / Vol. 65, No. 86 / Wednesday, May 3, 2000 / Rules and Regulations 25649

100% CT for all commodities. The

chronic dietary risk from food estimates

are less than 1% of the cPAD for the

general U.S. population and all

population subgroups. The results of the

analyses indicate that the chronic

dietary risks from food associated with

the existing and proposed uses of

pyridate do not exceed EPA’s level of

concern for the U.S. population or any

population subgroup

2. From drinking water. Although

pyridate does not possess the

environmental fate parameters

associated with a compound that could

leach to ground water, the fate

parameters of its degradate CL–9673

seem to indicate that it has the potential

to leach to ground water especially in

soils of low organic matter. In unusual

conditions such as flooding, where an

aerobic conditions exist in the top soil

layers for up to 60 days, CL–9673 could

persist and possibly leach to ground

water or run off to surface water.

Pyridate is not listed in the EPA

Pesticides in Ground Water Database,

nor is there an EPA Maximum

Contaminant Level or health advisory.

The Agency uses the Generic

Estimated Environmental Concentration

(GENEEC) or the Pesticide Root Zone/

Exposure Analysis Modeling System

(PRZM/EXAMS) to estimate pesticide

concentrations in surface water and

SCI–GROW, which predicts pesticide

concentrations in ground water. In

general, EPA will use GENEEC (a tier 1

model) before using PRZM/EXAMS (a

tier 2 model) for a screening-level

assessment for surface water.

The GENEEC model is a subset of the

PRZM/EXAMS model that uses a

specific high-end run off scenario for

pesticides. GENEEC incorporates a farm

pond scenario, while PRZM/EXAMS

incorporate an index reservoir

environment in place of the previous

pond scenario. The PRZM/EXAMS

model includes a percent crop area

factor as an adjustment to account for

the maximum percent crop coverage

within a watershed or drainage basin.

None of these models include

consideration of the impact processing

(mixing, dilution, or treatment) of raw

water for distribution as drinking water

would likely have on the removal of

pesticides from the source water. The

primary use of these models by the

Agency at this stage is to provide a

coarse screen for sorting out pesticides

for which it is highly unlikely that

drinking water concentrations would

ever exceed human health levels of

concern.

Since the models used are considered

to be screening tools in the risk

assessment process, the Agency does

not use the estimates environmental

concentration (EECs) from these models

to quantify drinking water exposure and

risk as a %RfD or %PAD. Instead

drinking water levels of comparisons

(DWLOCs) are calculated and used as a

point of comparison against the model

estimates of a pesticide’s concentration

in water. DWLOCs are theoretical upper

limits on a pesticide’s concentration in

drinking water in light of total aggregate

exposure to a pesticide in food, and

from residential uses. Since DWLOCs

address total aggregate exposure to

pyridate, they are further discussed in

the aggregate risk sections below.

EPA has calculated DWLOCs for both

acute and chronic risks. To calculate the

DWLOC for acute exposure relative to

an acute toxicity endpoint, the acute

dietary food exposure (from DEEM was

subtracted from the aPAD to obtain the

acceptable acute exposure to pyridate in

drinking water. To calculate the

DWLOC for chronic (non-cancer)

exposure relative to a chronic toxicity

endpoint, the chronic dietary food

exposure (from DEEM) was subtracted

from the cPAD to obtain the acceptable

chronic (non-cancer) exposure to

pyridate in drinking water. DWLOCs

were then calculated using default body

weights and drinking water

consumption figures.

i. Acute exposure. Based on the

GENEEC and SCI–GROW models the

EECs of pyridate in drinking water for

acute exposures are estimated to be 97

parts per billion (ppb) for surface water

and 5 ppb for ground water.

ii.Chronic exposure. Based on the

GENEEC and SCI–GROW models the

EECs in drinking water for chronic

exposures are estimated to be 25 ppb for

surface water and 5 pbb for ground

water.

3. From non-dietary exposure. There

are no residential or non- occupational

uses for pyridate; therefore, residential

exposures are not expected.

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

pyridate 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,

pyridate 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 pyridate 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. A high-end exposure

estimate from residues in food was

calculated for the general U.S.

population and all population

subgroups. The acute dietary exposure

from food for all populations subgroups

(<1% aPAD) is below EPA’s level of

concern. The maximum EECs of

pyridate in surface and ground water are

less than EPA’s DWLOCs for pyridate as

a contribution to acute aggregate

exposure (Table 1).

TABLE 1. AGGREGATE RISK ASSESSEMENT FOR ACUTE EXPOSURE

Population Subgroups % aPAD

mg/kg/day

Food

Exposure

mg/kg/day

SCI–GROW

(ppb)

GENEEC

(ppb)

DWLOC

(ppb)

U.S. population (48 contiguous states) ................................................... <1 0.000151 5 97 7,000

Non-nursing infants .................................................................................. <1 0.000278 5 97 2,000

Children 1–6 yrs. old ................................................................................ <1 0.000303 5 97 2,000

Females 13+ yrs. old (nursing) (60 kg body weight assumed) ............... <1 0.000149 5 97 7,000

Males 13–19 yrs. old ............................................................................... <1 0.000141 5 97 7,000

25650 Federal Register / Vol. 65, No. 86 / Wednesday, May 3, 2000 / Rules and Regulations

Therefore, EPA concludes with

reasonable certainty that residues of

pyridate in drinking water do not

contribute significantly to the aggregate

acute human health risk at the present

time considering the present uses and

uses proposed in this action. Acute risk

estimates resulting from aggregate

exposure to pyridate in food and water

are below EPA’s level of concern for all

population subgroups.

2. Chronic risk. Using the Tier 1

exposure assumptions described in this

unit, EPA has concluded that aggregate

exposure to pyridate from food will

utilize <1% of the cPAD for the U.S.

population. The major identifiable

subgroup with the highest aggregate

exposure is infants or children. 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. Despite the

potential for exposure to pyridate in

drinking water, EPA does not expect the

aggregate exposure to exceed 100% of

the cPAD, as indicated in Table 2.

TABLE 2. CHRONIC (NON-CANCER) AGGREGATE RISK ASSESSMENT

cPAD

mg/kg/day

Food

Exposure

mg/kg/day

SCI–GROW

(ppb)

GENEEC

(ppb)

DWLOC

(ppb)

U.S. population (48 contiguous states) ................................................... <1 0.000048 5 25 3,900

Non-nursing infants .................................................................................. <1 0.000121 5 25 1,100

Children 1–6 yrs ...................................................................................... <1 0.000114 5 25 1,100

Females 13+ (nursing) ............................................................................. <1 0.000046 5 25 3,900

Males 13–19 yrs. ..................................................................................... <1 0.000057 5 25 3,900

EPA concludes that there is a

reasonable certainty that no harm will

result from aggregate chronic exposure

to pyridate residues.

3. Short- and intermediate-term risk.

Short- and intermediate-term aggregate

exposure takes into account chronic

dietary food and water (considered to be

a background exposure level) plus

indoor and outdoor residential

exposure. Because there are no uses of

pyridate that could result in residential

exposures, the short- and intermediateterm aggregate risk assessment for

pyridate takes into account exposure

estimates only from dietary

consumption of pyridate (food and

drinking water). EPA concludes that

there is a reasonable certainty that no

harm will result from aggregate shortand intermediate-term exposure to

pyridate residues.

4. Aggregate cancer risk for U.S.

population. Pyridate is not carcinogenic

in either the rat or the mouse, and

therefore is not expected to pose a

cancer risk to humans.

5. 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 pyridate residues.

E. Aggregate Risks and Determination of

Safety for Infants and Children

1. Safety factor for infants and

children—i. In general. In assessing the

potential for additional sensitivity of

infants and children to residues of

pyridate, 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.

ii. Developmental toxicity studies.

The developmental toxicity study in

Wistar HAN rats resulted in increased

incidences of missing and ossified

sternebrae and decreased fetal body

weight. Maternal toxicity was

characterized by a decrease in the mean

body weight and food consumption and

clinical signs which were indicative of

neurotoxicity (ventral body position,

dyspnea, sedation and loss of reaction to

external stimuli). Developmental and

maternal NOAELs were 165 mg/kg/day.

In the developmental toxicity study in

New Zealand White rabbits, no

developmental effects were reported at

the NOAEL of 600 mg/kg/day and

maternal toxicity was characterized by

decreased body weight and body weight

gain, decreased food consumption,

increased incidences of dried feces and

increased incidences of abortion at the

LOAEL of 600 mg/kg/day. The maternal

NOAEL was 300 mg/kg/day.

iii. Reproductive toxicity study. The

3–generation reproduction study in rats

resulted in a decrease in maternal body

weight gain and a decrease in pup

weight gain at postnatal days 14 and 21.

Both parental and offspring toxicity

were reported at the high dose of 67.5

mg/kg/day.

iv. Prenatal and postnatal sensitivity.

The data demonstrated no indication of

increased sensitivity in utero and

postnatal exposure to pyridate.

v. Conclusion. There is a complete

toxicity data base for pyridate, and

exposure data are complete or are

estimated based on data that reasonably

accounts for potential exposures. The

Agency believes that reliable data

support using the standard 100-fold

safety factor for assessing sensitivity to

residues of pyridate and that an

additional 10-fold margin of safety for

infants and children is not warranted.

2. Acute risk. As presented in Table

1 above, EPA does not expect the

aggregate exposure to exceed 100% of

the aPAD.

3. Chronic risk. Using the exposure

assumptions described in this unit, EPA

has concluded that aggregate exposure

to pyridate from food will utilize <1%

of the cPAD for infants and children.

EPA generally has no concern for

exposures below 100% of the cPAD,

Federal Register / Vol. 65, No. 86 / Wednesday, May 3, 2000 / Rules and Regulations 25651

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.

Despite the potential for exposure to

pyridate in drinking water, EPA does

not expect the aggregate exposure to

exceed 100% of the cPAD.

4. Short- or intermediate-term risk.

Because there are no uses of pyridate

that could result in residential

exposures, the acute aggregate risk

assessment for pyridate takes into

account exposure estimates only from

dietary consumption of pyridate (food

and drinking water).

5. 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

pyridate residues.

IV. Other Considerations

A. Metabolism in Plants and Animals

The nature of the residue in plants

and ruminant animals is adequately

understood. The residue of concern in

plants consist of pyridate, the

metabolite CL–9673, and conjugates of

CL–9673, all expressed as pyridate.

B. Analytical Enforcement Methodology

The analytical method is a total

residue procedure using ultraviolet-high

pressure liquid chromotography. The

method has undergone validation in

EPA laboratories and is suitable to

enforce tolerances.

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. International Residue Limits

There is neither a Codex proposal, nor

Canadian or Mexican limits for residues

of pyridate in the subject crops.

Therefore, a compatibility issue is not

relevant to the proposed tolerances.

V. Conclusion

Therefore, the tolerance is established

for combined residues of pyridate and

its metabolite CL–9673 and conjugates

of CL–9673, in or on peppermint tops

and spearmint tops at 0.20 ppm,

Brassica, head and stem subgroup, and

collards at 0.03 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.

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–300989 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

20460. 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–300989, 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.

25652 Federal Register / Vol. 65, No. 86 / Wednesday, May 3, 2000 / Rules and Regulations

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 tolerances

under FFDCA section 408(d) in

response to the petitions 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

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 17, 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), (346a) and

371.

2. In § 180.462, by alphabetically

adding the following commodities to the

table in paragraph (a) to read as follows:

§ 180.462 Pyridate; tolerance for residues.

* * * * *

(a) * * *

Commodity Parts per

million

Brassica, head and stem subgroup ....................................... 0.03

*****

Collards ....................................... 0.03

*****

Peppermint tops ......................... 0.20

*****

Spearmint tops ........................... 0.20

* * * * *

[FR Doc. 00–10813 Filed 5–2–00; 8:45 am]

BILLING CODE 6560–50–F

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Part 180

[OPP–300996; FRL–6554–8]

RIN 2070–AB78

Fludioxonil; Re-Establishment of

Tolerance for Emergency Exemptions

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Final rule.

SUMMARY: This regulation re-establishes

time-limited tolerances for residues of

the fungicide fludioxonil in or on

apricots, nectarines, peaches, and plums

at 5.0 part per million (ppm) for an

additional 2-year period. These

tolerances will expire and are revoked

on December 31, 2001. This action is in

response to EPA’s granting of an

emergency exemption under section 18

of the Federal Insecticide, Fungicide,

and Rodenticide Act authorizing use of

the pesticide on apricots, nectarines,

peaches, and plums. Section 408(l)(6) of

the Federal Food, Drug, and Cosmetic

Act requires EPA to establish a timelimited tolerance or exemption from the

requirement for a tolerance for pesticide

chemical residues in food that will

result from the use of a pesticide under