41720 Federal Register / Vol. 63, No. 150 /Wednesday, August 5, 1998 /Rules and Regulations

DEPARTMENT OF TRANSPORTATION

Coast Guard

33 CFR Part 117

[CGD 08–98–045]

Drawbridge Operating Regulation;

Dulac Bayou, LA

AGENCY: Coast Guard, DOT.

ACTION: Notice of temporary deviation

from regulations.

SUMMARY: The Commander, Eighth

Coast Guard District has issued a

temporary deviation from the regulation

in 33 CFR 117.5 governing the operation

of the SR 57 swing span drawbridge

across Dulac Bayou, mile 0.6, at Dulac,

Terrebonne Parish, Louisiana. This

deviation allows the Lousiana

Department of Transportation and

Development to close the bridge from 7

a.m. until noon and from 12:30 p.m.

until 3:30 p.m., on August 3, 4, 5, 10,

11, 12, 17, 18 and 19, 1998. The span

will open for the passage of traffic from

noon until 12:30 p.m. on each of these

days. The bridge will operate normally

at all other times. In the event of an

approaching tropical storm or hurricane,

the draw will return to normal operation

within 12 hours of notification by the

Coast Guard. This temporary deviation

is issued to allow for cleaning and

painting the swing span, an extensive

but necessary maintenance operation.

DATES: This deviation is effective from

7 a.m. on August 3 until 3:30 p.m. on

August 19, 1998.

FOR FURTHER INFORMATION CONTACT:

Mr. Phil Johnson, Bridge Administration

Branch, Commander (ob), Eighth Coast

Guard District, 501 Magazine Street,

New Orleans, Louisiana, 70130–3396,

telephone number 504–589–2965.

SUPPLEMENTARY INFORMATION: The SR 57

swing span drawbridge across Dulac

Bayou, mile 0.6, in Dulac, Terrebonne

Parish, Louisiana, has a vertical

clearance of 7 feet above high water in

the closed-to-navigation position and

unlimited clearance in the open-tonavigation position. Navigation on the

waterway consists of tugs with tows,

fishing vessels, sailing vessels, and

other recreational craft. The Louisiana

Department of Transportation and

Development requested a temporary

deviation from the normal operation of

the bridge in order to accommodate the

maintenance work. The maintenance

work involves cleaning and painting of

the swing span and is essential for the

continued operation of the draw span.

This deviation allows the draw of the

SR 57 swing span bridge across Dulac

Bayou, mile 0.6, at Dulac to remain in

the closed-to-navigation position

between 7 a.m. and noon and from

12:30 p.m. until 3:30 p.m., on August 3,

4, 5, 10, 11, 12, 17, 18 and 19, 1998. The

span will open for the passage of traffic

from noon until 12:30 on each of these

days. The bridge will operate normally

at all other times.

This deviation will be effective from

7 a.m. on August 3 until 3:30 p.m. on

August 19, 1998. Presently, the draw

opens on signal at any time.

Dated July 28, 1998.

A.L. Gerfin, Jr.

Captain, U.S. Coast Guard Commander, 8th

Coast Guard District.

[FR Doc. 98–20931 Filed 8–4–98; 8:45 am]

BILLING CODE 4910–15–M

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Part 180

[OPP–300689; FRL–6018–5]

RIN 2070-AB78

Buprofezin; Pesticide Tolerances for

Emergency Exemptions

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Final rule.

SUMMARY: This regulation establishes

time-limited tolerances for residues of

buprofezin in or on cucurbits, tomatoes

and tomato paste. 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 cucurbits and tomatoes.

This regulation establishes a maximum

permissible level for residues of

buprofezin in these food commodities

pursuant to section 408(l)(6) of the

Federal Food, Drug, and Cosmetic Act,

as amended by the Food Quality

Protection Act of 1996. These tolerances

will expire and are revoked on

December 31, 1999.

DATES: This regulation is effective

August 5, 1998. Objections and requests

for hearings must be received by EPA on

or before October 5, 1998.

ADDRESSES: Written objections and

hearing requests, identified by the

docket control number, [OPP–300689],

must be submitted to: Hearing Clerk

(1900), Environmental Protection

Agency, Rm. M3708, 401 M St., SW.,

Washington, DC 20460. Fees

accompanying objections and hearing

requests shall be labeled ‘‘Tolerance

Petition Fees’’ and forwarded to: EPA

Headquarters Accounting Operations

Branch, OPP (Tolerance Fees), P.O. Box

360277M, Pittsburgh, PA 15251. A copy

of any objections and hearing requests

filed with the Hearing Clerk identified

by the docket control number, [OPP–

300689], must also be submitted to:

Public Information and Records

Integrity Branch, Information Resources

and Services Division (7502C), Office of

Pesticide Programs, Environmental

Protection Agency, 401 M St., SW.,

Washington, DC 20460. In person, bring

a copy of objections and hearing

requests to Rm. 119, CM #2, 1921

Jefferson Davis Hwy., Arlington, VA.

A copy of objections and hearing

requests filed with the Hearing Clerk

may also be submitted electronically by

sending electronic mail (e-mail) to: oppdocket@epamail.epa.gov. Copies of

objections and hearing requests must be

submitted as an ASCII file avoiding the

use of special characters and any form

of encryption. Copies of objections and

hearing requests will also be accepted

on disks in WordPerfect 5.1/6.1 file

format or ASCII file format. All copies

of objections and hearing requests in

electronic form must be identified by

the docket control number [OPP300689]. No Confidential Business

Information (CBI) should be submitted

through e-mail. Electronic copies of

objections and hearing requests on this

rule may be filed online at many Federal

Depository Libraries.

FOR FURTHER INFORMATION CONTACT: By

mail: Andrew Ertman, Registration

Division (7505C), Office of Pesticide

Programs, Environmental Protection

Agency, 401 M St., SW., Washington,

DC 20460. Office location, telephone

number, and e-mail address: Crystal

Mall #2, 1921 Jefferson Davis Hwy.,

Arlington, VA, (703) 308–9367, e-mail:

ertman.andrew@epamail.epa.gov.

SUPPLEMENTARY INFORMATION: EPA, on

its own initiative, pursuant to section

408(e) and (l)(6) of the Federal Food,

Drug, and Cosmetic Act (FFDCA), 21

U.S.C. 346a(e) and (l)(6), is establishing

tolerances for residues of the insecticide

buprofezin, in or on cucurbits at 0.5

parts per million (ppm), tomatoes at 0.7

ppm, and tomato paste at 1.0 ppm.

These tolerances will expire and are

revoked on December 31, 1999. EPA

will publish a document in the Federal

Register to remove the revoked

tolerances from the Code of Federal

Regulations.

I. Background and Statutory Authority

The Food Quality Protection Act of

1996 (FQPA) (Pub. L. 104-170) was

signed into law August 3, 1996. FQPA

amends both the Federal Food, Drug,

and Cosmetic Act (FFDCA), 21 U.S.C.
Federal Register / Vol. 63, No. 150 /Wednesday, August 5, 1998 /Rules and Regulations 41721

301 et seq., and the Federal Insecticide,

Fungicide, and Rodenticide Act

(FIFRA), 7 U.S.C. 136 et seq. The FQPA

amendments went into effect

immediately. Among other things,

FQPA amends FFDCA to bring all EPA

pesticide tolerance-setting activities

under a new section 408 with a new

safety standard and new procedures.

These activities are described below and

discussed in greater detail in the final

rule establishing the time-limited

tolerance associated with the emergency

exemption for use of propiconazole on

sorghum (61 FR 58135, November 13,

1996)(FRL-5572-9).

New 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. . . .’’

Section 18 of FIFRA authorizes EPA

to exempt any Federal or State agency

from any provision of FIFRA, if EPA

determines that ‘‘emergency conditions

exist which require such exemption.’’

This provision was not amended by

FQPA. EPA has established regulations

governing such emergency exemptions

in 40 CFR part 166.

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 FIFRA. Such

tolerances can be established without

providing notice or period for public

comment.

Because decisions on section 18-

related tolerances must proceed before

EPA reaches closure on several policy

issues relating to interpretation and

implementation of the FQPA, EPA does

not intend for its actions on such

tolerance to set binding precedents for

the application of section 408 and the

new safety standard to other tolerances

and exemptions.

II. Emergency Exemption for

Buprofezin on Cucurbits and FFDCA

Tolerances

Buprofezin was requested for use on

cucurbits in Arizona to control

whiteflies. The applicant states that the

whitefly has been a major pest in

Arizona since the late 1980’s and has

caused significant economic loss in a

host of crops throughout the region. In

Arizona, without efficacious control of

whitefly, losses top $30 million

annually to the watermelon and

cantaloupe industries.

The host range for whitefly is broad

and includes such commercial crops as

cotton, melons and other cucurbit crops,

cole crops, tomatoes, leafy vegetables,

alfalfa and citrus. Urban ornamental

plantings (such as lantana, hibiscus,

brittlebush, rose, mints, etc.) and native

vegetation (cheeseweed, mallows, etc.)

are also host crops for the whitefly. The

year round availability of hosts provides

the foundation for an endemic

population of whitefly, given the right

environmental conditions and a lack of

effective registered pesticides to

suppress or control populations. What

makes Arizona an excellent area for the

commercial production of a variety of

agricultural crops also makes it ideal for

the annual survival of the whitefly.

Feeding whiteflies extract critical

crop nutrients causing defoliation,

stunting and yield losses. In addition,

quality losses are common in

commercial crops as the feeding

whitefly excretes a ‘‘sticky honeydew’’

that promotes the development of black

sooty mold. Both the mold development

and the ‘‘stickiness’’ result in quality

(economic) losses in addition to the

economic loss inherent in reduced

yields. Whiteflies are also vectors of

disease, cause physiological disorders,

and exacerbate a host of other

production problems including

increased plant stress leading to

increased water and nutrient needs. The

constant use of broad-spectrum

insecticides for the control of this pest

can lead to further damage by secondary

pests such as aphids and mites. Finally,

the continued and repeated use of the

same or similar classes of insecticides

has lead rapidly to the development of

resistance in whiteflies.

Buprofezin was also requested for use

on tomatoes in Florida to control the

silverleaf whitefly. Tomatoes are

produced and harvested year-round in

Florida. Tomato seedlings are grown in

planthouses and transplanted to fields.

Silverleaf whitefly is a key pest on

tomatoes from the seedling stage

through harvest in Florida year-round in

all production regions. High

populations feeding on plants cause

irregular ripening, reducing fruit value.

Whiteflies may also transmit tomato

mottle geminivirus (TMV) and tomato

yellow leaf curl virus (TYLCV) during

feeding. TYLCV was discovered in

tomatoes in Florida in the summer of

1997 and is, therefore, a new pestrelated problem. Because whitefly is

such a good vector of the virus and the

virus is so prevalent, only minimal

infestations of whitefly are required to

transmit TYLCV to tomato plants.

Alternative control practices include

cultural control methods, natural

enemies, and resistant varieties.

Removal of alternate and overwintering

host plants, use of trap crops, use of

reflective mulches, and planting of

windbreaks have not resulted in

adequate whitefly control. Natural

enemies suppress whitefly but, alone,

do not provide adequate control.

Buprofezin and pyriproxifen, because

they are IGRs that only affect immature

insect development or development of

eggs, are less detrimental to natural

enemies than are broad-spectrum

insecticides. Resistant tomato varieties

adapted to the Florida climate have not

been developed.

No effective registered insecticides are

available in Florida to manage Silverleaf

Whitefly. In order to prevent spread of

TYLCV, whitefly populations must be

kept at a minimal level from

transplanted seedling stage through

harvest (up to 110 days). Systemic

imidacloprid was very effective for

controlling irregular ripening and TMV

caused by whitefly before TYLCV

became a problem in Florida. Because

imidacloprid is only applied once and

does not protect plants for the first two

weeks after transplanting or for the last

several weeks before harvest, it does not

provide whitefly control required to

prevent TYLCV infection of plants. Up

to two applications each of both

buprofezin and pyriproxifen will be

required for protection of plants for the

entire growing season. Field testing in

Florida has demonstrated that whitefly

has developed an unacceptable level of

resistance to recommended foliar

pyrethroids, methamidophos, and other

registered products. EPA has authorized

under FIFRA section 18 the use of

buprofezin on cucurbits for control of

whiteflies in Arizona and tomatoes for

control of the silverleaf whitefly in

Florida. After having reviewed the

submissions, EPA concurs that

emergency conditions exist for these

states.

As part of its assessment of this

emergency exemption, EPA assessed the
41722 Federal Register / Vol. 63, No. 150 /Wednesday, August 5, 1998 /Rules and Regulations

potential risks presented by residues of

buprofezin in or on cucurbits and

tomatoes. In doing so, EPA considered

the new safety standard in FFDCA

section 408(b)(2), and EPA decided that

the necessary tolerances under FFDCA

section 408(l)(6) would be consistent

with the new safety standard and with

FIFRA section 18. Consistent with the

need to move quickly on the emergency

exemptions in order to address an

urgent non-routine situation and to

ensure that the resulting food is safe and

lawful, EPA is issuing these tolerances

without notice and opportunity for

public comment under section 408(e), as

provided in section 408(l)(6). Although

these tolerances will expire and are

revoked on December 31, 1999, under

FFDCA section 408(l)(5), residues of the

pesticide not in excess of the amounts

specified in the tolerances remaining in

or on cucurbits, tomatoes, and tomato

paste after that date will not be

unlawful, provided the pesticide is

applied in a manner that was lawful

under FIFRA, and the residues do not

exceed a level that was authorized by

these tolerances at the time of that

application. EPA will take action to

revoke these tolerances earlier if any

experience with, scientific data on, or

other relevant information on this

pesticide indicate that the residues are

not safe.

Because these tolerances are being

approved under emergency conditions

EPA has not made any decisions about

whether buprofezin meets EPA’s

registration requirements for use on

cucurbits or tomatoes or whether

permanent tolerances for these uses

would be appropriate. Under these

circumstances, EPA does not believe

that these tolerances serve as a basis for

registration of buprofezin by a State for

special local needs under FIFRA section

24(c). Nor do these tolerances serve as

the basis for any State other than

Arizona and Florida to use this

pesticide on these crops under section

18 of FIFRA without following all

provisions of section 18 as identified in

40 CFR part 166. For additional

information regarding the emergency

exemption for buprofezin, contact the

Agency’s Registration Division at the

address provided above.

III. Risk Assessment and Statutory

Findings

EPA performs a number of analyses to

determine the risks from aggregate

exposure to pesticide residues. First,

EPA determines the toxicity of

pesticides based primarily on

toxicological studies using laboratory

animals. These studies address many

adverse health effects, including (but

not limited to) reproductive effects,

developmental toxicity, toxicity to the

nervous system, and carcinogenicity.

Second, EPA examines exposure to the

pesticide through the diet (e.g., food and

drinking water) and through exposures

that occur as a result of pesticide use in

residential settings.

A. Toxicity

1. Threshold and non-threshold

effects. For many animal studies, a dose

response relationship can be

determined, which provides a dose that

causes adverse effects (threshold effects)

and doses causing no observed effects

(the ‘‘no-observed effect level’’ or

‘‘NOEL’’).

Once a study has been evaluated and

the observed effects have been

determined to be threshold effects, EPA

generally divides the NOEL from the

study with the lowest NOEL by an

uncertainty factor (usually 100 or more)

to determine the Reference Dose (RfD).

The RfD is a level at or below which

daily aggregate exposure over a lifetime

will not pose appreciable risks to

human health. An uncertainty factor

(sometimes called a ‘‘safety factor’’) of

100 is commonly used since it is

assumed that people may be up to 10

times more sensitive to pesticides than

the test animals, and that one person or

subgroup of the population (such as

infants and children) could be up to 10

times more sensitive to a pesticide than

another. In addition, EPA assesses the

potential risks to infants and children

based on the weight of the evidence of

the toxicology studies and determines

whether an additional uncertainty factor

is warranted. Thus, an aggregate daily

exposure to a pesticide residue at or

below the RfD (expressed as 100% or

less of the RfD) is generally considered

acceptable by EPA. EPA generally uses

the RfD to evaluate the chronic risks

posed by pesticide exposure. For shorter

term risks, EPA calculates a margin of

exposure (MOE) by dividing the

estimated human exposure into the

NOEL from the appropriate animal

study. Commonly, EPA finds MOEs

lower than 100 to be unacceptable. This

100-fold MOE is based on the same

rationale as the 100-fold uncertainty

factor.

Lifetime feeding studies in two

species of laboratory animals are

conducted to screen pesticides for

cancer effects. When evidence of

increased cancer is noted in these

studies, the Agency conducts a weight

of the evidence review of all relevant

toxicological data including short-term

and mutagenicity studies and structure

activity relationship. Once a pesticide

has been classified as a potential human

carcinogen, different types of risk

assessments (e.g., linear low dose

extrapolations or MOE calculation based

on the appropriate NOEL) will be

carried out based on the nature of the

carcinogenic response and the Agency’s

knowledge of its mode of action.

2. Differences in toxic effect due to

exposure duration. The toxicological

effects of a pesticide can vary with

different exposure durations. EPA

considers the entire toxicity data base,

and based on the effects seen for

different durations and routes of

exposure, determines which risk

assessments should be done to assure

that the public is adequately protected

from any pesticide exposure scenario.

Both short and long durations of

exposure are always considered.

Typically, risk assessments include

‘‘acute,’’ ‘‘short-term,’’ ‘‘intermediate

term,’’ and ‘‘chronic’’ risks. These

assessments are defined by the Agency

as follows.

Acute risk, by the Agency’s definition,

results from 1-day consumption of food

and water, and reflects toxicity which

could be expressed following a single

oral exposure to the pesticide residues.

High end exposure to food and water

residues are typically assumed.

Short-term risk results from exposure

to the pesticide for a period of 1-7 days,

and therefore overlaps with the acute

risk assessment. Historically, this risk

assessment was intended to address

primarily dermal and inhalation

exposure which could result, for

example, from residential pesticide

applications. However, since enaction of

FQPA, this assessment has been

expanded to include both dietary and

non-dietary sources of exposure, and

will typically consider exposure from

food, water, and residential uses when

reliable data are available. In this

assessment, risks from average food and

water exposure, and high-end

residential exposure, are aggregated.

High-end exposures from all three

sources are not typically added because

of the very low probability of this

occurring in most cases, and because the

other conservative assumptions built

into the assessment assure adequate

protection of public health. However,

for cases in which high-end exposure

can reasonably be expected from

multiple sources (e.g. frequent and

widespread homeowner use in a

specific geographical area), multiple

high-end risks will be aggregated and

presented as part of the comprehensive

risk assessment/characterization. Since

the toxicological endpoint considered in

this assessment reflects exposure over a

period of at least 7 days, an additional

degree of conservatism is built into the
Federal Register / Vol. 63, No. 150 /Wednesday, August 5, 1998 /Rules and Regulations 41723

assessment; i.e., the risk assessment

nominally covers 1-7 days exposure,

and the toxicological endpoint/NOEL is

selected to be adequate for at least 7

days of exposure. (Toxicity results at

lower levels when the dosing duration

is increased).

Intermediate-term risk results from

exposure for 7 days to several months.

This assessment is handled in a manner

similar to the short-term risk

assessment.

Chronic risk assessment describes risk

which could result from several months

to a lifetime of exposure. For this

assessment, risks are aggregated

considering average exposure from all

sources for representative population

subgroups including infants and

children.

B. Aggregate Exposure

In examining aggregate exposure,

FFDCA section 408 requires that EPA

take into account available and reliable

information concerning exposure from

the pesticide residue in the food in

question, residues in other foods for

which there are tolerances, residues in

groundwater or surface water that is

consumed as drinking water, and other

non-occupational exposures through

pesticide use in gardens, lawns, or

buildings (residential and other indoor

uses). Dietary exposure to residues of a

pesticide in a food commodity are

estimated by multiplying the average

daily consumption of the food forms of

that commodity by the tolerance level or

the anticipated pesticide residue level.

The Theoretical Maximum Residue

Contribution (TMRC) is an estimate of

the level of residues consumed daily if

each food item contained pesticide

residues equal to the tolerance. In

evaluating food exposures, EPA takes

into account varying consumption

patterns of major identifiable subgroups

of consumers, including infants and

children.The TMRC is a ‘‘worst case’’

estimate since it is based on the

assumptions that food contains

pesticide residues at the tolerance level

and that 100% of the crop is treated by

pesticides that have established

tolerances. If the TMRC exceeds the RfD

or poses a lifetime cancer risk that is

greater than approximately one in a

million, EPA attempts to derive a more

accurate exposure estimate for the

pesticide by evaluating additional types

of information (anticipated residue data

and/or percent of crop treated data)

which show, generally, that pesticide

residues in most foods when they are

eaten are well below established

tolerances.

Percent of crop treated estimates are

derived from federal and private market

survey data. Typically, a range of

estimates are supplied and the upper

end of this range is assumed for the

exposure assessment. By using this

upper end estimate of percent of crop

treated, the Agency is reasonably certain

that exposure is not understated for any

significant subpopulation group.

Further, regional consumption

information is taken into account

through EPA’s computer-based model

for evaluating the exposure of

significant subpopulations including

several regional groups, to pesticide

residues. For this pesticide, the most

highly exposed population subgroup

(children 1-6 years old) was not

regionally based.

IV. 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 buprofezin and to make a

determination on aggregate exposure,

consistent with section 408(b)(2), for

time-limited tolerances for residues of

buprofezin on cucurbits at 0.5 ppm,

tomatoes at 0.7 ppm, and tomato paste

at 1.0 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 buprofezin are

discussed below.

1. Acute toxicity. Acute RfD = 0.67

mg/kg/day; NOEL = 200 mg/kg/day. For

acute dietary risk assessment, the

Agency determined that the rat

developmental NOEL of 200 milligrams/

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

decreased fetal body weight and delayed

ossification, at the LOEL of 800 mg/kg/

day, from the rat developmental study

should be used for the acute dietary risk

assessment. This risk assessment will

evaluate developmental risks to females

13+ years of age. An MOE of 300 is

required (a factor of 3 for FQPA

considerations plus a factor of 100 to

account for inter-species extrapolation

and intra-species variability).

2. Short - and intermediate - term

toxicity. The Agency determined that

the maternal NOEL of 50 mg/kg/day in

the rabbit developmental study based on

decreases in body weight and food

consumption at the LOEL of 250 mg/kg/

day should be used for short and

intermediate-term exposure scenarios

for both dermal and inhalation

exposure. MOEs of 100 are required.

3. Chronic toxicity. EPA has

established the RfD for buprofezin at

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

a 2-year feeding study in dogs with a

NOEL of 2.0 mg/kg/day and an

uncertainty factor of 300 a factor of 3 for

FQPA considerations, due to inadequate

reproduction study, and a factor of 100

to account for inter-species

extrapolation and intra-species

variability based on a increased liver

weight, increased liver enzymes, and

bile duct hyperplasia at the LOEL of

20.0 mg/kg/day.

4. Carcinogenicity. Buprofezin has not

been evaluated by the OPP’s Hazard ID

Committee. However, buprofezin will be

likely be evaluated by the OPP Cancer

Peer Review Committee based on lung

and liver tumors in the mouse

carcinogenicity study. For the purposes

of these section 18 requests, the Agency

calculated the cancer risk for

buprofezin. The male mouse Q2* based

on combined lung tumors is 2.747 x

10-3. The female mouse Q1* on

combined tumors is 2.488 x 10-3.

B. Exposures and Risks

1. From food and feed uses. Section

18 time limited tolerances (40 CFR

180.511) have been established for the

residues of buprofezin at 1.0 ppm in or

on cotton seed; 2 ppm in citrus fruit; 10

ppm in dried citrus pulp; 20 ppm in

cotton gin byproducts; 0.5 ppm in meat

byproducts of cattle, goats, hogs, horse,

and sheep; 0.02 ppm in the meat and fat

of cattle, goats, hogs, horse, and sheep;

and 0.03 ppm in milk. No permanent

tolerances have been established. Risk

assessments were conducted by EPA to

assess dietary exposures and risks from

buprofezin 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 one day or single exposure. The acute

dietary (food only) risk assessment used

the TMRC. Since for acute dietary risk

assessment, the acute effect is based on

decreased fetal body weight and delayed

ossification, the population subgroup of

concern is females 13+ years of age. For

this subgroup, an MOE value of 20,000

(equivalent to 1.5% of the acute RfD)

was calculated using the high-end

exposure value of 0.01 mg/kg/day. This

result should be viewed as a

conservative risk estimate.
41724 Federal Register / Vol. 63, No. 150 /Wednesday, August 5, 1998 /Rules and Regulations

ii. Chronic exposure and risk. In

conducting this chronic dietary risk

assessment, EPA has made very

conservative assumptions — 100% of

cucurbits and tomatoes having

buprofezin tolerances will contain

buprofezin residues and those residues

would be at the level of the tolerance —

which result in an overestimation of

human dietary exposure. Thus, in

making a safety determination for this

tolerance, HED is taking into account

this conservative exposure assessment.

The existing buprofezin tolerances

(published, pending, and section 18

tolerances) include anticipated residues

for citrus commodities, and thus result

in an Anticipated Residue Contribution

(ARC) that is equivalent to the following

percentages of the RfD:

Population subgroup %RfD

U.S. Population (48 States) ...... 23.1%

U.S. Population - Summer Season ......................................... 26.0%

Nursing Infants (<1 year old) .... 12.4%

Non-Nursing Infants (<1 year

old) ........................................ 47.4%

Children (1-6 years old) ............ 48.2%

Children (7-12 years old) .......... 34.6%

Northeast Region ...................... 24.7%

North Central Region ................ 23.2%

Western Region ........................ 25.4%

Hispanics .................................. 25.4%

Non-Hispanic Whites ................ 23.7%

Non-Hispanic Others ................ 23.3%

Males (13-19 years old) ............ 23.5%

The subgroups listed above are: (1)

the U.S. population (48 states); (2) those

for infants and children; and, (3) the

other subgroups for which the

percentage of the RfD occupied is

greater than that occupied by the

subgroup U.S. population (48 states).

2. From drinking water. A Tier I

drinking water assessment of buprofezin

was conducted. This assessment

utilized GENEEC and SCI-GROW

screening models to provide estimates

of surface and ground water

contamination resulting from

applications of buprofezin. The

estimated environmental concentrations

(EECs) using the GENEEC model ranged

from a peak concentration of 2.82 parts

per billion (ppb) to a 21-day average of

1.31 ppb for aerial application. For

calculation of chronic DWLOCs, the

higher 21-day average value (i.e., aerial)

was used. Based on these screening

models, maximum concentrations are

not expected to exceed 3 ppb in surface

water and 0.013 ppb in ground water.

There are no established Maximum

Contaminant Level for residues of

buprofezin in drinking water. No health

advisory levels for buprofezin in

drinking water have been established.

Acute and chronic exposure and risk.

The ‘‘Interim Guidance for Conducting

Drinking Water Exposure and Risk

Assessments’’ issued on 24-NOV-1997

using the GENEEC and the SCI-GROW

models was used to produce estimates

of buprofezin concentrations in surface

and ground water respectively. The

primary use of these models is to

provide a coarse screen for sorting out

pesticides for which OPP has a high

degree of confidence that the true levels

of the pesticide in drinking water will

be less than the human health drinking

water levels of concern (DWLOCs). The

DWLOC is an upper limit above which

residues in drinking water would result

in an unacceptable aggregate risk.

The DWLOCacute is the concentration

in drinking water as part of the acute

aggregate exposure that occupies no

more than 100% of the RfD acute. The

DWLOCchronic is the concentration in

drinking water as part of the aggregate

chronic exposure that occupies no more

than 100% of the RfDchronic. The

Agency’s default body weights and

consumption values used to calculate

DWLOCs are as follows: 70 kg/2L (adult

male), 60 kg/2L (adult female), and 10

kg/1L (child).

For chronic (non-cancer) exposure to

buprofezin in surface and ground water,

the drinking water levels of concern are

23,000 μg/L for the U.S. Population,

19800 for females (13+ years), and 6,400

μg/L for children (1-6 yrs). To calculate

the DWLOC for acute exposure relative

to a acute toxicity endpoint, the acute

dietary food exposure (from DRES) was

subtracted from the acute RfD to obtain

the acceptable acute exposure to

buprofezin in drinking water. To

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

toxicity endpoint, the chronic dietary

food exposure (from DRES) was

subtracted from the chronic RfD to

obtain the acceptable chronic (noncancer) exposure to buprofezin in

drinking water. DWLOCs were then

calculated using default body weights

and drinking consumption figures.

Estimated average concentrations of

buprofezin in surface and ground water

are 0.013 ppb and 1.31 ppb,

respectively. The estimated average

concentrations of buprofezin in surface

and ground water are less than OPP’s

level of concern for buprofezin in

drinking water as a contribution to

chronic aggregate exposure. Therefore,

taking into account present uses and

uses proposed in this action, OPP

concludes with reasonable certainty that

residues of buprofezin in drinking water

(when considered along with other

sources of exposure for which OPP has

reliable data) would not result in

unacceptable levels of aggregate human

health risk at this time.

3. From non-dietary exposure.

Buprofezin is an unregistered active

ingredient. Section 18 emergency

exemptions have been approved for use

on cotton, citrus, and tomatoes. An

experimental use permit (EUP) has been

granted for use on greenhouse

ornamental plants. There are no

registered residential uses for this

chemical.

4. Cumulative exposure to substances

with 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.’’

The Agency believes that ‘‘available

information’’ in this context might

include not only toxicity, chemistry,

and exposure data, but also scientific

policies and methodologies for

understanding common mechanisms of

toxicity and conducting cumulative risk

assessments. For most pesticides,

although the Agency has some

information in its files that may turn out

to be helpful in eventually determining

whether a pesticide shares a common

mechanism of toxicity with any other

substances, EPA does not at this time

have the methodologies to resolve the

complex scientific issues concerning

common mechanism of toxicity in a

meaningful way. EPA has begun a pilot

process to study this issue further

through the examination of particular

classes of pesticides. The Agency hopes

that the results of this pilot process will

increase the Agency’s scientific

understanding of this question such that

EPA will be able to develop and apply

scientific principles for better

determining which chemicals have a

common mechanism of toxicity and

evaluating the cumulative effects of

such chemicals. The Agency anticipates,

however, that even as its understanding

of the science of common mechanisms

increases, decisions on specific classes

of chemicals will be heavily dependent

on chemical specific data, much of

which may not be presently available.

Although at present the Agency does

not know how to apply the information

in its files concerning common

mechanism issues to most risk

assessments, there are pesticides as to

which the common mechanism issues

can be resolved. These pesticides

include pesticides that are

toxicologically dissimilar to existing

chemical substances (in which case the

Agency can conclude that it is unlikely
Federal Register / Vol. 63, No. 150 /Wednesday, August 5, 1998 /Rules and Regulations 41725

that a pesticide shares a common

mechanism of activity with other

substances) and pesticides that produce

a common toxic metabolite (in which

case common mechanism of activity

will be assumed).

EPA does not have, at this time,

available data to determine whether

buprofezin 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,

buprofezin 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 buprofezin has a common

mechanism of toxicity with other

substances.

C. Aggregate Risks and Determination of

Safety for U.S. Population

1. Acute risk. For the subpopulation

group of concern, females 13+ years, the

acute dietary exposure to buprofezin

from food will utilize 1.5 % of the acute

RfD (calculated MOE is 20,000). The

maximum concentrations of buprofezin

in surface and ground water are less

than OPP’s levels of concern for

buprofezin in surface and ground water

as a contribution to acute aggregate risk.

Therefore, the aggregate acute risk (food

+ water) is not expected to exceed the

Agency’s level of concern for acute

dietary exposure.

2. Chronic risk. Using the ARC

exposure assumptions described above,

EPA has concluded that aggregate

exposure to buprofezin from food will

utilize 23.1% of the RfD for the U.S.

population. The major identifiable

subgroup with the highest aggregate

exposure is discussed below. 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 buprofezin in drinking

water and from non-dietary, nonoccupational exposure, EPA does not

expect the aggregate exposure to exceed

100% of the RfD. EPA concludes that

there is a reasonable certainty that no

harm will result from aggregate

exposure to buprofezin 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. There are no registered

residential uses for buprofezin,

therefore, the potential short and

intermediate-term aggregate risks are

adequately addressed by the chronic

aggregate dietary (food + water)

assessment.

D. Aggregate Cancer Risk for U.S.

Population

Based on the buprofezin Q2*, the

dietary cancer risk for the U.S.

population is 2.7 x 10 -7.

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

buprofezin, 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 during

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 10-fold margin

of safety for infants and children in the

case of threshold effects to account for

pre-and post-natal 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 MOE

analysis or through using uncertainty

(safety) factors in calculating a dose

level that poses no appreciable risk to

humans. In either case, EPA generally

defines the level of appreciable risk as

exposure that is greater than 1/100 of

the no observed effect level in the

animal study appropriate to the

particular risk assessment. This 100-fold

uncertainty (safety) factor/MOE (safety)

is designed to account for inter-species

extrapolation and intra-species

variability. HED believes that reliable

data support using the 100-fold margin/

factor, rather than the 1,000-fold

margin/factor, when EPA has a

complete data base under existing

guidelines, and when the severity of the

effect in infants or children, the potency

or unusual toxic properties of a

compound, or the quality of the

exposure data do not raise concerns

regarding the adequacy of the standard

margin/factor.

ii. Developmental toxicity studies. In

a developmental study in rats, the

maternal (systemic) NOEL was 200 mg/

kg/day, based on mortality, decreased

pregnancy rates, and increased

resorptions at the LOEL of 800 mg/kg/

day. The developmental (fetal) NOEL

was 200 mg/kg/day, based on increased

incidence of delayed ossifications and

decreased pup weight at the LOEL of

800 mg/kg/day.

In a developmental toxicity study in

rabbits, the maternal (systemic) NOEL

was 50 mg/kg/day, based on body

weight and food consumption and

possibly increased fetal loss at the LOEL

of 250 mg/kg/day. The developmental

(pup) NOEL was 250 mg/kg/day (highest

dose tested).

iii. Reproductive toxicity study. The 2-

generation reproductive toxicity in rats

does not satisfy guideline requirements

for a reproduction study and is

considered a data gap.

iv. Pre- and post-natal sensitivity. The

toxicological data base for evaluating

pre- and post-natal toxicity for

buprofezin is not complete with respect

to current data requirements, since there

is no adequate reproduction study.

There are no pre- or post-natal toxicity

concerns for infants and children, based

on the results of the rat and rabbit

developmental toxicity studies, but the

Agency recommends an additional

FQPA factor of 3 due to the absence of

the reproduction study and the possible

incomplete assessment of extrasensitivity to infants and children.

v. Conclusion. Based on the above, the

Agency concludes that reliable data

support use of a 300-fold margin of

exposure/uncertainty factor, rather than

the standard 1,000-fold margin/factor, to

protect infants and children for acute

dietary MOE requirements and the

determination of the RfD.

2. Acute risk. For females 13+ years,

the acute dietary exposure (maternal

and fetal) to buprofezin from food will

utilize 1.5% of the acute RfD (calculated

MOE is 20,000). These calculations are

based on a developmental NOEL in rats

of 200 mg/kg/day. This risk assessment

assumed 100% crop treated with

tolerance level residues on all treated

crops consumed, resulting in a

significant overestimate of dietary

exposure. The maximum concentrations

of buprofezin in surface and ground

water are less than OPP’s levels of

concern for buprofezin in surface and

ground water as a contribution to acute

aggregate risk. Therefore, the aggregate

acute risk (food + water) is not expected

to exceed OPP’s level of concern for

acute dietary exposure.

3. Chronic risk. Using the

conservative exposure assumptions

described above, EPA has concluded

that aggregate exposure to buprofezin

from food ranges from 12.4% of the RfD
41726 Federal Register / Vol. 63, No. 150 /Wednesday, August 5, 1998 /Rules and Regulations

for nursing infants less than 1 years old,

up to 48.2% of the RfD for children 1-

6 years old. 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.

The estimated average concentrations of

buprofezin in surface and ground water

are less than OPP’s levels of concern for

buprofezin in surface and ground water

as a contribution to chronic aggregate

risk. Under current HED guidelines, the

non-dietary uses of buprofezin do not

constitute a chronic exposure scenario.

4. Short- or 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 uses.

There are no registered residential uses

for buprofezin, therefore the potential

short and intermediate-term aggregate

risks are adequately addressed by the

chronic aggregate dietary (food + water)

risk assessment.

V. Other Considerations

A. Metabolism In Plants and Animals

The nature of the residue in plants is

adequately understood for purposes of

this section 18 only. Studies conducted

in tomatoes, lettuce, cotton, and citrus

indicate that the residue of concern is

the parent buprofezin (BF1, 2-tertbutylimino-3-isopropyl-5-

phenylperhydro-1,3,5-thiadizinan-4-

one) only. The nature of the residue in

animals (rats and fish) is consistent with

that determined for crops.

B. Analytical Enforcement Methodology

Adequate enforcement methodology

(gas chromatography using a nitrogenphosphorous detector) is available to

enforce the proposed tolerance on

cucurbits and tomatoes. The method

was validated by an independent

laboratory using lettuce, tomato, and

cucumber as the test matrices. Samples

of the test matrices were fortified with

buprofezin at 0.1 ppm, 0.5 ppm, and 1.0

ppm. Recoveries were reported as 90%,

94%, and 82% for lettuce, tomato, and

cucumber respectively. In addition,

methodology for buprofezin and its

metabolites in cottonseed and gin trash

is summarized in the report

‘‘Determination of Buprofezin and BF 12

residues in Cottonseed and Gin Trash,’’

Method BF-96-01, AgrEvo Corporation,

Wilmington, Delaware. The limit of

detection for buprofezin is 0.01 ppm

and the limit of quantitation is 0.02

ppm.

C. Magnitude of Residues

Residues of buprofezin are not

expected to exceed 0.5 ppm in/on

cucurbits or 0.7 ppm in/on tomatoes

and 1.0 ppm in tomato paste as a result

of these section 18 uses.

D. International Residue Limits

A temporary Codex MRL of 1.0 mg/kg

has been established for buprofezin on

tomatoes (pending additional data

submission). There are no Canadian or

Mexican MRLs for buprofezin on

tomatoes. Therefore, compatibility

problems may exist (i.e., the Codex MRL

is higher than the U.S. tolerance) which

will need to be addressed when a

permanent section 3 tolerance for

buprofezin on tomatoes is granted.

E. Rotational Crop Restrictions

The following plant-back restrictions

are required: - 30 days for brassica and

non-brassica leafy vegetables, small

grains, and radishes - 120 days for all

other crops.

VI. Conclusion

Therefore, the tolerance is established

for residues of buprofezin in cucurbits

at 0.5 ppm, tomatoes at 0.7 ppm, and

tomato paste at 1.0 ppm.

VII. Objections and Hearing Requests

The new FFDCA section 408(g)

provides essentially the same process

for persons to ‘‘object’’ to a tolerance

regulation issued by EPA under new

section 408(e) and (l)(6) as was provided

in the old section 408 and in section

409. However, the period for filing

objections is 60 days, rather than 30

days. EPA currently has procedural

regulations which govern the

submission of objections and hearing

requests. These regulations will require

some modification to reflect the new

law. However, until those modifications

can be made, EPA will continue to use

those procedural regulations with

appropriate adjustments to reflect the

new law.

Any person may, by October 5, 1998,

file written objections to any aspect of

this regulation and may also request a

hearing on those objections. Objections

and hearing requests must be filed with

the Hearing Clerk, at the address given

above (40 CFR 178.20). A copy of the

objections and/or hearing requests filed

with the Hearing Clerk should be

submitted to the OPP docket for this

rulemaking. The objections submitted

must specify the provisions of the

regulation deemed objectionable and the

grounds for the objections (40 CFR

178.25). Each objection must be

accompanied by the fee prescribed by

40 CFR 180.33(i). If a hearing is

requested, the objections must include a

statement of the factual issues on which

a hearing is requested, the requestor’s

contentions on such issues, and a

summary of any evidence relied upon

by the requestor (40 CFR 178.27). A

request for a hearing will be granted if

the Administrator determines that the

material submitted shows the following:

There is 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 in the manner sought by the

requestor would be adequate to justify

the action requested (40 CFR 178.32).

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.

VIII. Public Record and Electronic

Submissions

EPA has established a record for this

rulemaking under docket control

number [OPP–300689] (including any

comments and data submitted

electronically). A public version of this

record, including printed, paper

versions of electronic comments, which

does not include any information

claimed as CBI, is available for

inspection from 8:30 a.m. to 4 p.m.,

Monday through Friday, excluding legal

holidays. The public record is located in

Room 119 of the Public Information and

Records Integrity Branch, Information

Resources and Services Division

(7502C), Office of Pesticide Programs,

Environmental Protection Agency,

Crystal Mall #2, 1921 Jefferson Davis

Highway, Arlington, VA.

Electronic comments may be sent

directly to EPA at:

opp-docket@epamail.epa.gov.

Electronic comments must be

submitted as an ASCII file avoiding the

use of special characters and any form

of encryption.

The official record for this

rulemaking, as well as the public

version, as described above will be kept

in paper form. Accordingly, EPA will

transfer any copies of objections and

hearing requests received electronically
Federal Register / Vol. 63, No. 150 /Wednesday, August 5, 1998 /Rules and Regulations 41727

into printed, paper form as they are

received and will place the paper copies

in the official rulemaking record which

will also include all comments

submitted directly in writing. The

official rulemaking record is the paper

record maintained at the Virginia

address in ‘‘ADDRESSES’’ at the

beginning of this document.

IX. Regulatory Assessment

Requirements

This final rule establishes tolerances

under FFDCA section 408(l)(6). 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) (Pub. L.

104-4). Nor does it require any prior

consultation as specified by Executive

Order 12875, entitled Enhancing the

Intergovernmental Partnership (58 FR

58093, October 28, 1993), or 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 in

accordance with Executive Order 13045,

entitled Protection of Children from

Environmental Health Risks and Safety

Risks (62 FR 19885, April 23, 1997).

In addition, since these tolerances and

exemptions that are established under

FFDCA section 408 (l)(6), 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. Nevertheless, the

Agency has previously assessed whether

establishing tolerances, exemptions

from tolerances, raising tolerance levels

or expanding exemptions might

adversely impact small entities and

concluded, as a generic matter, that

there is no adverse economic impact.

The factual basis for the Agency’s

generic certification for tolerance

acations published on May 4, 1981 (46

FR 24950), and was provided to the

Chief Counsel for Advocacy of the Small

Business Administration.

X. 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 the rule in

the Federal Register. This 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: July 16, 1998.

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. 346a and 371.

2. Section 180.511 is amending

paragraph (b) by alphabetically adding

the following entries to the table to read

as follows:

§ 180.511 Buprofezin; tolerances for

residues

* * * * *

(b) * * *

Commodity Parts per

million

Expiration/

Revocation

Date

* * * * *

Cucurbits ........... 0.5 12/31/99

* * * * *

Tomatoes .......... 0.7 12/31/99

Tomato paste .... 1.0 12/31/99

* * * * *

[FR Doc. 98–20906 Filed 8–4–98; 8:45 am]

BILLING CODE 6560–50–F

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Part 180

[OPP–300688; FRL–6018–4]

RIN 2070–AB78

Fluroxypyr 1-Methylheptyl Ester;

Pesticide Tolerances for Emergency

Exemptions

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Final rule.

SUMMARY: This regulation establishes

time-limited tolerances for the

combined residues of fluroxypyr 1-

methylheptyl ester and its metabolite

fluroxypyr in or on wheat, barley, field

corn, and sweet corn. 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 wheat, barley, field corn,

and sweet corn. This regulation

establishes a maximum permissible

level for residues of fluroxypyr 1-

methylheptyl ester and its metabolite

fluroxypyr in these food commodities

pursuant to section 408(l)(6) of the

Federal Food, Drug, and Cosmetic Act,

as amended by the Food Quality

Protection Act of 1996. These tolerances

will expire and are revoked on

December 1, 1999.

DATES: This regulation is effective

August 5, 1998. Objections and requests

for hearings must be received by EPA on

or before October 5, 1998.

ADDRESSES: Written objections and

hearing requests, identified by the

docket control number, [OPP–300688],

must be submitted to: Hearing Clerk

(1900), Environmental Protection

Agency, Rm. M3708, 401 M St., SW.,

Washington, DC 20460. Fees

accompanying objections and hearing

requests shall be labeled ‘‘Tolerance

Petition Fees’’ and forwarded to: EPA

Headquarters Accounting Operations

Branch, OPP (Tolerance Fees), P.O. Box

360277M, Pittsburgh, PA 15251. A copy

of any objections and hearing requests

filed with the Hearing Clerk identified

by the docket control number, [OPP–

300688], must also be submitted to:

Public Information and Records

Integrity Branch, Information Resources

and Services Division (7502C), Office of

Pesticide Programs, Environmental

Protection Agency, 401 M St., SW.,

Washington, DC 20460. In person, bring

a copy of objections and hearing

requests to Rm. 119, CM #2, 1921

Jefferson Davis Hwy., Arlington, VA.