24392 Federal Register / Vol. 65, No. 81 / Wednesday, April 26, 2000 / Rules and Regulations

Subpart G—Significant New

Alternatives Policy Program

* * * * *

Appendix I to Subpart G—Substitutes

Subject to Use Restrictions, Listed in

the April 26, 2000, Final Rule, Effective

May 26, 2000

FIRE SUPPRESSION AND EXPLOSION PROTECTION—TOTAL FLOODING AGENTS

[Substitutes Acceptable Subject to Use Conditions]

End Use Substitute Decision Conditions Comments

Halon 1301 Total Flooding Systems.IG–100 Acceptable ......... IG–100 systems should be designed to

maintain an oxygen level of 10%. A

design concentration of less than

10% may only be used in normally

unoccupied areas and in areas where

egress is possible within 30 seconds.

If it is not possible to egress an area

within one minute, IG–100 systems

must be designed to maintain an oxygen level of 12%

If the possibility exists for oxygen levels

to drop below 10%, employees must

be evacuated prior to such oxygen

depletion.

IG–100 systems must include alarms

and warning mechanisms.

Workplace personnel and employees

should not remain in or re-enter the

area after system discharge (even if

such discharge is accidental) without

appropriate personal protective equipment.

See additional comments 1, 2, 3.

Additional Comments: 

1. Should conform with OSHA 29 CFR 1910, Subpart L, Section 1910.160.

2. Per OSHA requirements, protective gear (SCBA) should be available in the event personnel must re-enter the area.

3. EPA has no intention of duplicating or displacing OSHA coverage related to the use of personal protective equipment (e.g., respiratory protection), fire protection, hazard communication, worker training or any other occupational safety and health standard with respect to EPA’s regulation of halon substitutes.

FIRE SUPPRESSION AND EXPLOSION PROTECTION—STREAMING AGENTS

[Substitutes Acceptable Subject to Narrowed Use Limits]

End Use Substitute Decision Limitations Comments

Halon 1211 Streaming

Agents.

HCFC Blend E ... Acceptable ......... Nonresidential uses only As with other streaming agents, EPA recommends that potential risks of combustion byproducts be labeled on the extinguisher (see

UL 2129).

See additional comments 1, 2.

Additional Comments: 

1. Discharge testing and training should be strictly limited only to that which is essential to meet safety or performance requirements.

2. The agent should be recovered from the fire protection system in conjunction with testing or servicing, and recycled for later use or

destroyed.

[FR Doc. 00–10422 Filed 4–25–00; 8:45 am]

BILLING CODE 6560–50–U

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Part 180

[OPP–300992; FRL–6554–4]

RIN 2070–AB78

Fenpropathrin; Pesticide Tolerance

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Final rule.

SUMMARY: This regulation establishes a

tolerance for residues of fenpropathrin

in or on the cucumber/squash crop

subgroup. The Interregional Research

Project Number 4 (IR–4) 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 April

26, 2000. Objections and requests for

hearings, identified by docket control

number OPP–300992, must be received

by EPA on or before June 26, 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–300992 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:

Categories NAICS

codes

Examples of potentially affected

entities

Industry 111 Crop production.

112 Animal production.

Federal Register / Vol. 65, No. 81 / Wednesday, April 26, 2000 / Rules and Regulations 24393

Categories NAICS

codes

Examples of potentially affected entities

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–300992. 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 December 3,

1999 (64 FR 679054) (FRL–6392–6),

EPA issued a notice pursuant to section

408 of the FFDCA, 21 U.S.C. 346a as

amended by the FQPA (Public Law 104–

170) announcing the filing of a pesticide

petition (PP 9E6042) for tolerance by

IR–4, Rutgers State University, North

Brunswick, NJ 08902–3390. This notice

included a summary of the petition

prepared by Valent USA Company, 1333

North California Boulevard, Suite 600,

Walnut Creek, CA 94596–8025, the

registrant. There were no comments

received in response to the notice of

filing.

The petition requested that 40 CFR

180.466 be amended by establishing a

tolerance for residues of the insecticide

fenpropathrin, (alpha-cyano-3-phenoxybenzyl 2,2,3,3- tetramethylcyclopropanecarboxylate), in or

on the cucurbit vegetable group at 0.5

part per million (ppm). The petition was

subsequently amended by IR–4 to

propose a tolerance for the squash/

cucumber subgroup at 0.5 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 fenpropathrin on the

cucumber/squash crop subgroup at 0.5

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 fenpropathrin are

discussed in this unit.

B. Toxicological Endpoints

1. Acute toxicity. An acute reference

dose (RfD) of 0.06 mg/kg/day was

established based on clinical signs of

neurotoxicity on the day of dosing in

dams during a developmental toxicity

study in rats. The no observed adverse

effect level (NOAEL) was 6.0

milligrams/kilograms/day (mg/kg/day).

An uncertainty factor of 100 (10X for

interspecies extrapolation and 10X for

intraspecies variations) was used to

determine the acute RfD. The acute

Population Adjusted Dose (PAD) is

equal to the acute RfD divided by the

FQPA Safety Factor. Since the FQPA

Safety Factor was reduced to 1X, the

acute PAD is equal to the acute RfD.

2.Chronic toxicity. EPA has

established the RfD for fenpropathrin at

0.025 mg/kg/day. This RfD is based on

the observance of tremors in dogs in the

1-year oral feeding study. The NOAEL

was 2.5 mg/kg/day. An uncertainty

factor of 100 (10X for interspecies

extrapolation and 10X for intraspecies

variation) was used to determine the

chronic RfD. The chronic PAD is equal

to the chronic RfD divided by the FQPA

Safety Factor. Since the FQPA Safety

Factor was reduced to 1X, the chronic

PAD is equal to the chronic RfD.

3. Carcinogenicity. As no indication of

carcinogenicity was seen in rats or mice,

no carcinogenic endpoint was selected.

C. Exposures and Risks

1. From food and feed uses.

Tolerances have been established (40

24394 Federal Register / Vol. 65, No. 81 / Wednesday, April 26, 2000 / Rules and Regulations

CFR 180.466) for the residues of

fenpropathrin, in or on a variety of raw

agricultural commodities. Permanent

tolerances are established for the

residues of fenpropathrin in/on pome

fruit crop group at 5.0 ppm; grapes at

5.0 ppm and the processed product

raisins at 10 ppm; citrus fruit crop group

at 2.0 ppm and the processed product

citrus oil at 75.0 ppm and dried citrus

pulp at 4.0 ppm; head and stem brassica

crop group at 3.0 ppm and the melons

crop group at 0.5 ppm. Risk assessments

were conducted by EPA to assess

dietary exposures from fenpropathrin 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 3 acute

dietary exposure analyses for

fenpropathrin were performed with the

Dietary Exposure Evaluation Model

(DEEMTM) using field trial values and

percent crop treated estimates. The

acute risk was analyzed at the 99.9th

percentile using the 1989–1992 food

consumption survey. The U.S.

population and population subgroups

(with the exception of nursing infants,

all infants, and children) acute dietary

risk estimates are below EPA’s level of

concern. The acute dietary risk

estimates for subgroups of nursing

infants, all infants, and children were

above EPA’s level of concern. In the

1989–1992 survey, there is a

consumption value associated with

grapes which can be considered to be

aberrant. There were only 4 nursing

infants in the 1989–1992 survey who

reportedly ate grapes. A single 10-month

old nursing infant consumed 2/3 of a

pound of grapes in 1 day. This is an

unusually high quantity of grapes for an

infant to consume in 1 day. Because of

the aberrant data point, the acute dietary

exposure analysis was conducted using

the 1994–1996 food consumption

survey.

ii. Chronic exposure and risk. A

DEEMTM chronic dietary exposure

analysis was performed using

anticipated residues (field trial data)

and percent crop treated data. The

FQPA 10X safety factor was removed.

As a result, the chronic PAD is

equivalent to the chronic RfD: 0.025 mg/

kg/day. Based on the 1989–1992 data

base, the most highly exposed subgroup

(children 1–6 years) utilized 9% of the

chronic PAD. As a result, exposure to

fenpropathrin of the U.S. population

and all population subgroups is below

EPA’s level of concern.

2. From drinking water.

Fenpropathrin is persistent and

immobile. There are no established

maximum contaminant level for

residues of fenpropathrin in drinking

water. Neither has any health advisory

levels for fenpropathrin in drinking

water been established.

The Agency lacks sufficient waterrelated exposure data to complete a

comprehensive dietary exposure

analysis and risk assessment for

fenpropathrin in drinking water.

Because the Agency does not have

comprehensive monitoring data,

drinking water concentration estimates

must be made by reliance on some sort

of simulation or modeling. The Agency

is currently relying on GENEEC (Generic

Estimated Environmental

Concentration) and PRZM/EXAMS for

surface water, which are used to

produce estimates of pesticide

concentrations in a farm pond and SCI–

GROW (Screening Concentration in

Ground Water), which predicts

pesticide concentrations in ground

water. None of these models include

consideration of the impact processing

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 estimates are

used as screening tools in the risk

assessment process, the Agency does

not use the estimates from GENEEC,

PRZM/EXAMS and SCI–GROW to

quantify drinking water exposure and

risk as a %RfD or %PAD. Instead

drinking water levels of comparison

(DWLOC) 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, drinking

water, and residential uses. Different

populations have different DWLOCs.

EPA uses DWLOCs internally in the risk

assessment process as a surrogate

measure of potential exposure

associated with pesticide exposure

through drinking water. In the absence

of monitoring data for pesticides, it is

used as a point of comparison against

conservative model estimates of a

pesticide’s concentration in water.

DWLOC values are not regulatory

standards for drinking water. They do

have an indirect regulatory impact

through aggregate exposure and risk

assessments.

The Agency used its SCI–GROW and

GENEEC screening models and

environmental fate data to determine

the estimated environmental

concentration (EEC) for fenpropathrin in

ground water and surface water

respectively. EPA reported ground water

EEC of 0.006 parts per billion (ppb) and

surface water EECs of 2.72 ppb (acute)

and 0.34 ppb (chronic) for

fenpropathrin.

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 acute PAD to obtain

the acceptable acute exposure to

fenpropathrin in drinking water. To

calculate the DWLOC for chronic (noncancer) exposure relative to a chronic

toxicity endpoint, the chronic dietary

food exposure (from DEEM) was

subtracted from the chronic PAD to

obtain the acceptable chronic (noncancer) exposure to fenpropathrin in

drinking water. DWLOCs were then

calculated using default body weights

and drinking water consumption

figures.

i. Acute exposure and risk. The

drinking water EEC for dietary

exposures at the 99.9th percentile

exceeds the DWLOC for the population

subgroups all infants, nursing infants,

and children 1–6 years. The DWLOCs,

which were calculated based on the

exposure values at the 99.5th percentile

of exposure for nursing infants and at

the 99.75th percentile of exposure for all

infants and for children 1–6 years, were

above the drinking water EEC. The same

is true for the DWLOCs calculated based

on the 99.9th percentile exposure values

from the 1994–1996 food consumption

survey. For the reasons discussed in

Unit C.1.i. EPA has chosen to use data

from the 1994–1996 food consumption

survey for these three population

subgroups (and for this risk assessment

only). Although the dietary exposure

estimates are highly refined, EPA notes

that 100% crop treated was used for the

following crops: cucurbit group, grapes,

pome fruit group, citrus group, and head

and stem Brassica vegetable subgroup.

Based on percent crop treated values for

registered uses, the percent crop treated

for these uses will probably be

significantly less than 100%.

ii.Chronic exposure and risk. EPA

generally reduces GENEEC model

values by a factor of 3 when

determining whether or not a chronic

level of comparison has been exceeded.

If the GENEEC model value is ≤ 3 times

the DWLOC, the pesticide is considered

to have passed the screen and no further

assessment is needed.

Based on the chronic dietary (food)

exposure estimates, chronic DWLOC for

Federal Register / Vol. 65, No. 81 / Wednesday, April 26, 2000 / Rules and Regulations 24395

fenpropathrin have been calculated. The

lowest DWLOC is 230 ppb for both

nursing infants and children 1–6 years.

The highest EEC for fenpropathrin in

surface water is from the application of

fenpropathrin to pears and citrus fruits

(0.34 ppb) and is substantially lower

than the DWLOCs calculated. Therefore,

chronic exposure to fenpropathrin

residues in drinking water are not

expected to exceed EPA’s level of

concern.

3. From non-dietary exposure. There

are no residential or non-occupational

uses for fenpropathrin; 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

fenpropathrin 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, fenpropathrin

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 fenpropathrin 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. For this risk assessment,

the acute aggregate risk is equivalent to

the risk from (food + water). Using the

1994–96 food consumption survey, it is

estimated that acute exposure to

fenpropathrin from food for the most

highly exposed population subgroup,

children (1–6 years), will utilize 76% of

the acute PAD at the 99.9 percentile of

exposure (see discussion in Unit III.C.).

An acute dietary exposure (food +

water) of 100% or less of the acute PAD

is needed to protect the safety of all

population subgroups. The EECs of

fenpropathrin in surface and ground

water for acute exposure are below the

DWLOCs. Thus, the acute aggregate risk

of exposure to fenpropathrin from food

and drinking water is below EPA’s level

of concern for the U.S. population and

all population subgroups.

2. Chronic risk. For this risk

assessment, the chronic aggregate risk is

equivalent to the risk from (food +

water). Chronic residential exposure to

fenpropathrin residues is not expected.

In addition, no chronic dermal or

inhalation endpoints were identified. As

discussed above, EPA has concluded

that exposure to fenpropathrin from

food for the most highly exposed

subgroup (children 1–6 years) will

utilize 9% of the chronic PAD. EPA

generally has no concern for exposure

below 100% of the chronic PAD because

the chronic PAD represents the level at

or below which daily aggregate dietary

exposure over a lifetime will not pose

appreciable risks to human health. The

highest EEC for fenpropathrin in

drinking water (0.34 ppb) is

substantially lower than the lowest

DWLOC (230 ppb). Therefore, chronic

aggregate risk does not exceed EPA’s

level of concern.

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. Since there is no expected

residential exposure to residues of

fenpropathrin, the short- and

intermediate-term aggregate risk does

not exceed EPA’s level of concern.

4. Aggregate cancer risk for U.S.

population. The Agency has determined

that there is no evidence of

carcinogenicity in studies in either the

mouse or rat.

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 fenpropathrin 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

fenpropathrin, 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. In

a developmental toxicity study in rats,

pregnant female rats were dosed by

gavage on gestation days 6–15 at 0 (corn

oil control), 0.4, 1.5, 2.0, 3.0, 6.0, or 10.0

mg/kg/day. The maternal NOAEL is 6

mg/kg/day; maternal LOAEL is 10 mg/

kg/day based on death, moribundity,

ataxia, sensitivity to external stimuli,

spastic jumping, tremors, prostration,

convulsions, hunched posture, squinted

eyes, chromodacryorrhea, and

lacrimation; developmental NOAEL is >

10 mg/kg/day. There were no

developmental effects observed under

the conditions of the study.

In a developmental toxicity study in

rabbits, pregnant female New Zealand

rabbits were dosed by gavage on

gestation days 7 through 19 at 0, 4, 12,

or 36 mg/kg/day. Maternal NOAEL is 4

mg/kg/day; maternal LOAEL is 12 mg/

kg/day based on grooming, anorexia,

flicking of the forepaws; developmental

NOAEL is > 36 mg/kg/day highest dose

tested. There were no developmental

effects observed under the conditions of

the study.

iii. Reproductive toxicity study. A 3-

generation reproduction study was

performed in rats. Rats were dosed with

fenpropathrin at concentrations of 0, 40,

120, or 360 ppm (0, 3.0, 8.9, or 26.9 mg/

kg/day in males; 0, 3.4, 10.1, or 32.0 mg/

kg/day in females, respectively). Parents

(male/female): Systemic NOAEL = 40

ppm (3.0/3.4 mg/kg/day). Systemic

LOAEL = 120 ppm (8.9/10.1 mg/kg/day)

based on body tremors with spasmodic

muscle twitches, increased sensitivity

24396 Federal Register / Vol. 65, No. 81 / Wednesday, April 26, 2000 / Rules and Regulations

and maternal lethality; reproductive

NOAEL = 120 ppm (8.9/10.1 mg/kg/

day). Reproductive LOAEL = 360 ppm

(26.9/32.0 mg/kg/day) based on decrease

mean F1B pup weight, increased F2B

loss. Pups (male/female):

Developmental NOAEL = 40 ppm (3.0/

3.4 mg/kg/day). Developmental LOAEL

= 120 ppm (8.9/10.1 mg/kg/day) based

on body tremors, and increased

mortality.

iv. Prenatal and postnatal sensitivity.

There is no evidence of sensitivity to

young rats or rabbits following prenatal

or postnatal exposure to fenpropathrin.

v. Conclusion. There is a complete

toxicity data base for fenpropathrin, and

exposure data are complete or are

estimated based on data that reasonably

accounts for potential exposures. Based

on the above, EPA concludes that

reliable data support use of the 100-fold

uncertainty factor and that an additional

uncertainty factor is not needed to

protect the safety of infants and

children.

2. Acute risk. (food + water) The

percentages of the acute PAD utilized

(by food alone) at the 99.9 percentile

exposure are 56% for infants and 77%

for children (1–6 years), the most highly

exposed population subgroup. The EEC

for fenpropathrin in drinking water is

below the DWLOC. The Agency has no

cause for concern if total acute exposure

is 100% or less of the acute PAD.

Therefore, the Agency has no acute

aggregate concern due to exposure to

fenpropathrin through food and

drinking water.

3. Chronic risk. Using the exposure

assumptions described in this unit, EPA

has concluded that aggregate exposure

to fenpropathrin from food will utilize

5% of the RfD for infants and 9% of the

RfD for children. EPA generally has no

concern for exposures below 100% of

the RfD because the RfD 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

fenpropathrin in drinking water and

from non-dietary, non-occupational

exposure, EPA does not expect the

aggregate exposure to exceed 100% of

the RfD.

4. Short- or intermediate-term risk. No

uses of fenpropathrin have been

identified for residential exposures,

therefore, fenpropathin need not be

evaluated for short- or intermediateterm risk resulting from residential

exposure.

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

fenpropathrin residues.

IV. Other Considerations

A. Metabolism in Plants and Animals

The nature of the residue in plants

and animals is adequately understood.

B. Analytical Enforcement Methodology

EPA concludes that adequate

methodology is available for

enforcement of the proposed tolerances.

Method RM–22–4 can be used for the

analysis of fenpropathrin in cucurbits.

Residues are extracted with acetone/

hexane, cleaned up with silica gel and

C18 Sep Pak chromatography and

detection is by gas chromatography. The

limit of detection is 0.01 ppm.

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

Adequate residue field trials reflecting

the prosed use rate were submitted to

EPA to demonstrate that tolerances for

cucumber/squash crop subgroup will

not be exceeded when fenpropathrin

products labeled for these uses are used

as directed.

V. Conclusion

Therefore, the tolerance is established

for residues of fenpropathrin, (alphacyano-3-phenoxy-benzyl 2,2,3,3-tetramethylcyclopropanecarboxylate), in or

on the cucumber/squash crop subgroup

at 0.5 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–300992 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 June 26, 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

Federal Register / Vol. 65, No. 81 / Wednesday, April 26, 2000 / Rules and Regulations 24397

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–300992, 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

issue(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

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 11, 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 § 180.466, amend paragraph (a)

by alphabetically adding the following

entry to the table to read as follows:

§ 180.466 Fenpropathrin; tolerances for

residues.

(a) General. * * *

24398 Federal Register / Vol. 65, No. 81 / Wednesday, April 26, 2000 / Rules and Regulations

Commodity Parts

per million

*****

Squash/cucumber subgroup ... 0.5

*****

*****

[FR Doc. 00–10042 Filed 4–25–00; 8:45 am]

BILLING CODE 6560–50–F

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Part 180

[OPP–300993; FRL–6554–6]

RIN 2070–AB78

Thiabendazole; Extension of Tolerance

for Emergency Exemptions

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Final rule.

SUMMARY: This regulation extends a

time-limited tolerance for residues of

the fungicide thiabendazol and its

metabolites in or on lentils at 0.1 part

per million (ppm) for an additional 20–

month period. This tolerance will expire

and is revoked on December 31, 2001.

This action is in response to EPA’s

granting of emergency exemptions

under section 18 of the Federal

Insecticide, Fungicide, and Rodenticide

Act authorizing use of the pesticide on

lentils. Section 408(l)(6) of the Federal

Food, Drug, and Cosmetic Act requires

EPA to establish a time-limited

tolerance or exemption from the

requirement for a tolerance for pesticide

chemical residues in food that will

result from the use of a pesticide under

an emergency exemption granted by

EPA under section 18 of the Federal

Insecticide, Fungicide, and Rodenticide

Act.

DATES: This regulation is effective April

26, 2000. Objections and requests for

hearings, identified by docket control

number OPP–300993, must be received

by EPA on or before June 26, 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 III. of the

SUPPLEMENTARY INFORMATION. To ensure

proper receipt by EPA, your objections

and hearing requests must identify

docket control number OPP–300993 in

the subject line on the first page of your

response.

FOR FURTHER INFORMATION CONTACT: By

mail: Andrea Beard, Registration

Division (7505C), Office of Pesticide

Programs, Environmental Protection

Agency, Ariel Rios Bldg., 1200

Pennsylvania Ave., NW., Washington,

DC 20460; telephone number: (703)

308–9356; and e-mail address:

beard.andrea@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–300993. 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, 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

EPA issued a final rule, published in

the Federal Register of February 25,

1998 (63 FR 9435) (FRL–5767–6), which

announced that on its own initiative

under 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), it established a

time-limited tolerance for the residues

of thiabendazole and its metabolites in

or on lentils at 0.1 ppm. Subsequently,

EPA extended that tolerance, published

in the Federal Register of December 4,

1998 (63 FR 66994) (FRL–6044–5) with

an expiration date of April 30, 2000.

EPA established the tolerance because

section 408(l)(6) of the FFDCA requires

EPA to establish a time-limited

tolerance or exemption from the

requirement for a tolerance for pesticide

chemical residues in food that will

result from the use of a pesticide under

an emergency exemption granted by

EPA under section 18 of the Federal

Insecticide, Fungicide, and Rodenticide

Act (FIFRA). Such tolerances can be

established without providing notice or

period for public comment.

EPA received a request to extend the

use of thiabendazole on lentils for this

year’s growing season due to the

situation remaining an emergency. The

Applicants (Idaho, Washington, North

Dakota, and Montana) state that the

ascochyta blight fungus has only

occurred in the United States in recent

years, and presently available fungicides

do not adequately control its spread in

lentils, to prevent significant economic

loss. Additionally, a recently-discovered

sexually-reproducing strain is of even

greater concern, as this sexual stage

releases spores, capable of traveling long

distances on the wind. This disease was