Federal Register / Vol. 63, No. 115 /Tuesday, June 16, 1998 /Rules and Regulations 32753

c. In paragraph (a), remove the phrase

‘‘on-site records of the maximum design

capacity’’ and add, in its place ‘‘on-site

records of the design capacity report

which triggered § 60.752(b)’’;

d. Add paragraph (f) to read as

follows:

§ 60.758 Recordkeeping Requirements.

* * * * *

(f) Landfill owners or operators who

convert design capacity from volume to

mass or mass to volume to demonstrate

that landfill design capacity is less than

2.5 million megagrams or 2.5 million

cubic meters, as provided in the

definition of ‘‘design capacity’’, shall

keep readily accessible, on-site records

of the annual recalculation of sitespecific density, design capacity, and

the supporting documentation. Off-site

records may be maintained if they are

retrievable within 4 hours. Either paper

copy or electronic formats are

acceptable.

14. Amend § 60.759 as follows:

a. In paragraph (a)(3)(iii), remove the

sentence ‘‘The values for k, LO, and

CNMOC determined in field testing shall

be used, if field testing has been

performed in determining the NMOC

emission rate or the radii of influence.’’

and add, in its place, the sentence ‘‘The

values for k and CNMOC determined in

field testing shall be used, if field testing

has been performed in determining the

NMOC emission rate or the radii of

influence (the distance from the well

center to a point in the landfill where

the pressure gradient applied by the

blower or compressor approaches

zero).’’

b. In paragraph (a)(3)(iii), remove the

sentence ‘‘If field testing has not been

performed, the default values for k, LO,

and CNMOC provided in § 60.754(a)(1)

shall be used’’ and add, in its place, the

sentence ‘‘If field testing has not been

performed, the default values for k, LO

and CNMOC provided in § 60.754(a)(1)

or the alternative values from

§ 60.754(a)(5) shall be used.

[FR Doc. 98–15007 Filed 6–15–98; 8:45 am]

BILLING CODE 6560–50–P

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Parts 180, 185 and 186

[OPP–300663; FRL–5793–5]

RIN 2070–AB78

Quizalofop-p ethyl ester; Pesticide

Tolerance

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Final rule.

SUMMARY: This regulation establishes

tolerances for combined residues of

quizalofop-p ethyl ester [ethyl (R)-(2-[4-

((6-chloroquinoxalin-2-yl)oxy)phenoxyl]

propanoate), and its acid metabolite

quizalofop-p [(R)-(2-[4-((6-

chloroquinoxalin-2-

yl)oxy)phenoxyl]propionate) and the S

enantiomers of the ester and the acid, all

expressed as quizalofop-p ethyl ester in

or on canola seed, canola meal,

peppermint tops and spearmint tops.

DuPont Agricultural Products requested

the tolerances for canola and the

Interregional Research Project Number 4

(IR-4) requested the tolerances for

peppermint and spearmint. These

tolerances were requested under the

Federal Food, Drug, and Cosmetic Act,

as amended by the Food Quality

Protection Act of 1996 (Pub. L. 104-170).

DATES: This regulation is effective June

16, 1998. Objections and requests for

hearings must be received by EPA on or

before August 17, 1998.

ADDRESSES: Written objections and

hearing requests, identified by the

docket control number, [OPP–300663],

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–

300663], 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 [OPP–

300663]. 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: Sidney Jackson, 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) 305-7610; e-mail:

jackson.sidney@epamail.epa.gov.

SUPPLEMENTARY INFORMATION: In the

Federal Register published on October

29, 1997 (62 FR 56176 (mint)) (FRL–

5749–7) and December 17, 1997, 62 FR

66080 (canola)) (FRL–5758–3), EPA,

issued notices pursuant to section 408

of the Federal Food, Drug, and Cosmetic

Act (FFDCA), 21 U.S.C. 346a(e)

announcing the filing of pesticide

petitions (PP) 6E4652 and 5F4545 for

tolerances by the IR-4 and DuPont

Agricultural Products, Wilmington,

Delaware. These notices included a

summary of the petitions prepared by

DuPont Agricultural Products,

Wilmington, Delaware, the registrant.

There were no comments received in

response to these notices of filing.

The petitions requested that 40 CFR

180.441 be amended by establishing

tolerances for combined residues of the

herbicide quizalofop-p ethyl ester [ethyl

(R)-(2-[4-((6-chloroquinoxalin-2-

yl)oxy)phenoxyl] propanoate), and its

acid metabolite quizalofop-p [(R)-(2-[4-

((6-chloroquinoxalin-2-yl)oxy)phenoxyl]

propionate) and the S enantiomers of

the ester and the acid, all expressed as

quizalofop-p ethyl ester, in or on canola

seed at 1.0 part per million (ppm),

canola meal at 1.5 ppm, and peppermint

tops and spearmint tops at 2.0 ppm. .

I. Risk Assessment and Statutory

Findings

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
32754 Federal Register / Vol. 63, No. 115 /Tuesday, June 16, 1998 /Rules and Regulations

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. 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

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
Federal Register / Vol. 63, No. 115 /Tuesday, June 16, 1998 /Rules and Regulations 32755

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

was not regionally based.

II. 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 quizalofop-p ethyl ester and

to make a determination on aggregate

exposure, consistent with section

408(b)(2), for a tolerance for combined

residues of quizalofop-p-ethyl ester on

canola seed at 1.0 ppm, canola meal at

1.5 ppm, and peppermint tops and

spearmint tops at 2.0 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 quizalofop-p

ethyl ester are discussed below.

1. Acute toxicity. Acute toxicology

studies include: acute oral toxicity

(lethal dose) (LD50s) at 1,480 and 1,670

milligrams (mg)/kilogram (kg) for female

and male rats, respectively); eye

irritation (not an eye irritant); dermal

toxicity (LD50 > 5,000 mg/kg in rats);

inhalation toxicity (lethal concentration)

(LC50 = 5.8 mg/liter(L)in rats); and

dermal irritation (not a dermal

sensitizer).

2. Genotoxicity. Quizalofop ethyl was

negative in the following genotoxicity

tests: bacterial gene mutation assays

(Ames assay); chromosomal aberration

assays in Chinese hamster ovary (CHO)

cells; unscheduled DNA synthesis; and

combinant assays and reversion assay in

Salmonella.

3. Reproductive and developmental

toxicity. A developmental toxicity study

in rats administered dosage levels of 0,

30, 100, and 300 mg/kg/day. The

maternal toxicity NOEL was 30 mg/kg/

day and a developmental toxicity NOEL

was greater than 300 mg/kg/day, highest

dose tested (HDT). The maternal NOEL

was based on reduced food

consumption and body weight, and

increased liver weights. There were no

developmental effects observed.

A developmental toxicity study in

rabbits administered dosage levels of 0,

7, 20, and 60 mg/kg/day with no

developmental effects noted at 60 mg/

kg/day (HDT). The maternal toxicity

NOEL was established at 20 mg/kg/day

based on decreased food consumption

and body weight at 60/mg/kg/day

(HDT).

In a two-generation reproductive

toxicity study, Sprague-Dawley rats

were fed diets containing quizalofop-pethyl at 0, 25, 100, or 400 ppm (0, 1.25,

5.0, or 20 mg/kg/day respectively). The

parental NOEL was 100 ppm (5.0 mg/

kg/day) and the lowest-observed effect

level (LOEL) was 400 ppm (20 mg/kg/

day), based on decreased body weights

in males of both generations. The

developmental NOEL for effects on the

offspring was 25 ppm (1.25 mg/kg/day)

and the offspring developmental LOEL

was 100 ppm (5.0 mg/kg/day), based on

increased incidence of eosinophilic

changes in the livers of F2 weanling. In

addition, at 400 ppm (20 mg/kg/day),

reductions in litter size, survival, body

weights, and spleen weight were seen in

offspring.

4. Subchronic toxicity. A 90-day study

was conducted in rats fed diets

containing 0, 40, 128, 1,280 ppm (or

approximately 0, 2, 6.4 and 64 mg/kg/

day, respectively). The NOEL was 2 mg/

kg/day. This was based on increased

liver weights at 6.4 mg/kg.

A 90-day feeding study in mice was

conducted with diets that contained 0,

100, 316 or 1,000 ppm (or

approximately 0, 15, 47.4, and 150 mg/

kg/day, respectively). The NOEL was <

15 mg/kg/day (lowest dose tested) based

on increased liver weights and

reversible histopathological effects in

the liver at the lowest dose tested.

5. Chronic toxicity. An 18-month

carcinogenicity study was conducted in

CD-1 mice fed diets containing 0, 2, 10,

80 or 320 ppm (or approximately 0, 0.3,

1.5, 12, and 48 mg/kg/day, respectively).

There were no carcinogenic effects

observed under the conditions of the

study at levels up to and including 12

mg/kg/day. A marginal increase in the

incidence of hepatocellular tumors was

observed at 48 mg/kg/day, the highest

dose tested (HDT) which exceeded the

maximum tolerated dose (MTD).

A 2-year chronic toxicity/

carcinogenicity study was conducted in

rats fed diets containing 0, 25, 100 or

400 ppm (or 0, 0.9, 3.7, and 15.5 mg/kg/

day for males and 0, 1.1, 4.6, and 18.6

mg/kg/day for females, respectively).

There were no carcinogenic effects

observed under the conditions of the

study at levels up to and including 18.6

g/kg/day (HDT). The systemic NOEL

was 0.9 mg/kg/day based on altered red

cell parameters and slight/minimal

centrilobuler enlargement of the liver at

3.7 mg/kg/day.

A 1-year feeding study was conducted

in dogs fed diets containing 0, 25, 100

or 400 ppm (or approximately 0, 0.625,

2.5, or 10 mg/kg/day, respectively). The

NOEL was greater than 10 mg/kg/day,

the lowest dose tested (LDT).

B. Toxicological Endpoints

1. Acute toxicity. There were no

effects observed in oral toxicity studies

that could be attributable to a single

dose (exposure). Therefore, a dose and

an endpoint have not been identified for

this risk assessment. This risk

assessment is not required. .

2. Short - and intermediate - term

toxicity. In a 21-day dermal toxicity

study, New Zealand White rabbits (5/

sex/dose) received 15 repeated dermal

applications (aqueous paste) of

quizalofop-p-ethyl ester at doses of 0,

125, 600 or 2,000 mg/kg/day, 6 hours/

day, 5 days/week over a 21-day period.

There was no dermal or systemic

toxicity. The NOEL was 2,000 mg/kg/

day. In addition, no maternal or

developmental toxicity was observed

following in utero exposures in rats and

rabbits. These risk assessments are not

required.

3. Chronic toxicity. EPA has

established the RfD for quizalofop-p

ethyl ester at 0.009 mg/kg/day. This RfD

is based on the 2-year feeding study in

rats. Groups of male and female

Sprague-Dawley rats (50/sex/dose) were

fed diets containing quizalofop-p-ethyl

ester at 0, 25, 100 or 400 ppm for 104

weeks. For chronic toxicity, the NOEL
32756 Federal Register / Vol. 63, No. 115 /Tuesday, June 16, 1998 /Rules and Regulations

was 25 ppm (0.9 mg/kg/day) and the

LOEL was 100 ppm based on the

occurrence of generalized hepatocyte

enlargement in female rats and red

blood cell destruction in males. In

addition, there was generalized

hepatocyte enlargement and red blood

cell destruction in both sexes at 400

ppm.

RfD = 0.9 mg/kg/day (NOEL) = 0.009

mg/kg/day 100 (UF).

4. Carcinogenicity. OPP’s Health

Effects Division, Carcinogenicity Peer

Review Committee (CPRC) has

evaluated the rat and mouse cancer

studies for quizalofop-p ethyl ester

along with other relevant short-term

toxicity, mutagenicity studies, and

structure-activity relationships. The

CPRC has classified quizalofop-p ethyl

as a Group D carcinogen (not classifiable

as to human cancer potential). The

Group D classification is based on an

approximate doubling in the incidence

of mice liver tumors between controls

and the high dose. This finding was not

considered strong enough to warrant the

classification of a Category C (possible

human carcinogen): the increase was of

marginal statistical significance,

occurred at high dose which exceeded

the MTD, and occurred in a study in

which the concurrent control for liver

tumors was somewhat low as compared

to the historical controls, while the high

dose control group was at the upper end

of previous historical control groups. No

new cancer studies are required for

quizalofop-p ethyl ester at this time.

C. Exposures and Risks

1. From food and feed uses.

Tolerances have been established (40

CFR 180.441) for the combined residues

of quizalofop-p ethyl ester and its acid

metabolite quizalofop-p and the S

enantiomers of the ester and the acid, all

expressed as quizalofop-p ethyl ester in

or on a variety of raw agricultural

commodities. Tolerances are established

for cottonseed at 0.1 ppm, lentils at 0.05

ppm. Time-limited tolerances are

established for sugarbeet roots at 0.1

ppm, sugarbeet tops at 0.5 ppm, legume

vegetables crop group at 0.25 ppm, and

foliage of legume vegetables (except

soybeans) at 3.0 ppm. Risk assessments

were conducted by EPA to assess

dietary exposures and risks from

quizalofop-p ethyl ester 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. There are

no acute toxicological concerns for

quizalofop-p ethyl ester.

ii. Chronic exposure and risk. In

conducting this chronic dietary risk

assessment, EPA has made very

conservative assumptions -- 100% of

mint, canola, and all other commodities

having quizalofop-p-ethyl ester

tolerances will contain the regulable

residues and those residues will be at

the level of the tolerance. Thus, in

making a safety determination for these

tolerances, EPA is taking into account

this conservative exposure assessment.

The Dietary Risk Evaluation System

(DRES) was used for the chronic dietary

exposure analysis. The analysis

evaluates individual food consumption

as reported by respondents in the USDA

1977-78 Nationwide Food Consumption

Survey (NFCS) and accumulates

exposure to the chemical for each

commodity. Regional consumption

information is taken into account

through EPA’s computer-based model

for evaluating the exposure of

significant subpopulations including

several regional groups. Review of these

regional data allows the Agency to be

reasonably certain that no regional

population is exposed to residue levels

higher than those estimated by the

Agency.

Existing tolerances and this rule for

canola and mint result in a TMRC of

5.40 x 10-4 mg/kg/day for the U.S.

general population (48 States), which

represents 6.0% of the RfD. The use on

canola will add a TMRC of 7.7 x 10-5

mg/kg/day, which represents 0.9% of

the RfD for the U.S. population. The use

on mint will add a TMRC of 2 x 10-6 mg/

kg/day, which represents 0.016% of the

RfD. Existing tolerances and this rule

result in a TMRC of 1.7 x 10-3 mg/kg/

day for the highest exposed population

subgroup (non-nursing infants <1 year

old), which represents 19%. These

tolerances for canola and mint will not

contribute to the dietary burden of this

population subgroup. Based on the risk

estimates calculated, chronic dietary

exposure does not exceed EPA’s level of

concern.

2. From drinking water— i. Acute

exposure and risk. There are no acute

toxicological concerns for quizalofop-p

ethyl ester.

ii. Chronic exposure and risk.

Drinking water levels of concern

(DWLOC) were calculated for chronic

dietary exposure. To calculate the

DWLOC, chronic dietary food exposure

(from DRES analysis) was subtracted

from the RfD. DWLOC were then

calculated using default bodyweights

and drinking water consumption

figures. For adults, the estimate was

based on a body weight of 60 kg

(female)/70 kg(female) and consumption

of 2 liters of water per day. For children,

a body weight of 10 kg and a

consumption of 1 liter of water per day

were used. The DWLOC are calculated

at 296 parts per billion (ppb) for the U.S.

population, 256 ppb for females (13+

years old, not pregnant or nursing) and

73 ppb for infants and children. Agency

estimates for quizalofop-p ethyl ester

contamination is 8 ppb for surface water

and 0.15 ppb for groundwater. These

levels are significantly less than levels

of concern to EPA.

3. From non-dietary exposure.

Quizalofop-p ethyl ester is not

registered for residential use sites.

4. Cumulative exposure to substances

with common mechanism of toxicity.

Quizalofop-p ethyl is a member of the

oxyphenoxy acid ester class of

pesticides. Other members of this class

include fluazifop-butyl, diclofopmethyl, fenoxaprop-ethyl, and

haloxyfop-methyl.

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
Federal Register / Vol. 63, No. 115 /Tuesday, June 16, 1998 /Rules and Regulations 32757

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

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

quizalofop-p ethyl ester 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, quizalofop-p

ethyl ester 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 quizalofop-p ethyl ester

has a common mechanism of toxicity

with other substances.

5. Endocrine disruption. EPA is

required to develop a screening program

to determine whether certain substances

(including all pesticides and inerts)

‘‘may have an effect in humans that is

similar to an effect produced by a

naturally occurring estrogen, or such

other endocrine effect....’’

The Agency is currently working with

interested stakeholders, including other

government agencies, public interest

groups, industry and research scientists

in developing a screening and testing

program and a priority setting scheme to

implement this program. Congress has

allowed 3 years from the passage of

FQPA (August 3, 1999) to implement

this program. EPA may require further

testing of this active ingredient and end

use products for endocrine disrupter

effects.

D. Aggregate Risks and Determination of

Safety for U.S. Population

1. Acute risk. There are no acute

toxicological concerns for quizalofop-p

ethyl ester.

2. Chronic risk. Using the TMRC

exposure assumptions described above,

EPA has concluded that aggregate

exposure to quizalofop-p ethyl ester

from food will utilize 6.0% of the RfD

for the U.S. population. The major

identifiable subgroup with the highest

aggregate exposure is non-nursing

infants <1 year old at 19% of the RfD.

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

quizalofop-p ethyl ester 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 quizalofop-p ethyl ester

residues.

E. Aggregate Cancer Risk for U.S.

Population

The Agency has classified quizlopfopp ethyl as a Category D chemical (not

classifiable as to human cancer

potential) based on results of rat and

mouse cancer studies along with other

relevant short-term toxicity,

mutagenicity studies, and structureactivity relationships. The Group D

classification is based on an

approximate doubling in the incidence

of mice liver tumors between controls

and the high dose. This finding was not

considered strong enough to warrant the

classification of a Category C (possible

human carcinogen): the increase was of

marginal statistical significance,

occurred at high dose which exceeded

the MTD, and occurred in a study in

which the concurrent control for liver

tumors was somewhat low as compared

to the historical controls, while the high

dose control group was at the upper end

of previous historical control groups.

Based on results of the above adequate

studies and the Category D

classification, the Agency believes that

any cancer risk posed by quizalofop-p

ethyl is negligible and there is

reasonable certainty that no harm will

result from exposure to residue of

quizalofop-p ethyl.

F. 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

quizalofop-p ethyl ester, EPA

considered data from developmental

toxicity studies in the rat and rabbit and

a two-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

pre-and post-natal toxicity and the

completeness of the database 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. EPA believes that reliable data

support using the standard uncertainty

factor (usually 100 for combined interand intra-species 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.

Developmental toxicity studies showed

no increased sensitivity in fetuses as

compared to maternal animals following

in utero exposures in rats and rabbits.

iii. Reproductive toxicity study. In a

two generation reproductive toxicity

study, rats were fed diets of 0, 1.25, 5.0

or 20 mg/kg/day of quizalofop-p ethyl.

The parental NOEL was 5.0 mg/kg/day

and the LOEL was 20 mg/kg/day, based

on decreased body weights in males of

both generations. The developmental

NOEL for effects on the offspring was

1.25 mg/kg/day and the offspring

developmental LOEL was 5.0 mg/kg/

day, based on increased incidence of

eosinophilic changes in the livers of F2

weanling. In addition, at 20 mg/kg/day,

reductions in litter size, survival, body

weights, and spleen weight were seen in

the offspring.

iv. Pre- and post-natal sensitivity. The

histopathology data for F2 weanlings in

the two-generation reproductive toxicity

study suggested an increased sensitivity

to the offspring. In that study, an

increase in the incidence of eosinophilic

changes in the liver were noted in the

F2 weanlings, and the offspring NOEL

was less than the parental systemic

NOEL. However, the significance of

these observations in the two-generation

reproductive toxicity study is rendered

questionable due to: (a) The changes in

the weanling livers were not well

characterized; (b) the biological

significance of this endpoint was not

known; (c) the precise dose of test

substance to 21-day old weanlings

cannot be determined with any

accuracy, but it is likely to exceed that

of the adults; (d) this endpoint
32758 Federal Register / Vol. 63, No. 115 /Tuesday, June 16, 1998 /Rules and Regulations

(eosinophilic changes), in adults, would

not be considered appropriate for use in

regulation of a chemical because of the

questionable biological significance of

this effect; and, (e) previous

toxicological studies show the liver as

the target organ in rats. No particular

significance to the offspring is attributed

to the liver effects.

v. Conclusion. The database is

complete and the weight of the evidence

reveals no special susceptibility to

developmental toxicity. Therefore, EPA

has determined that reliable data

support use of the standard 100-fold

safety factor. An additional ten-fold

safety factor is not necessary to protect

the safety of infants and children.

2. Acute aggregate risk. There are no

acute toxicological concerns for

quizalofop-p ethyl ester.

3. Chronic aggregate risk. Using the

conservative exposure assumptions

described above, EPA has concluded

that aggregate exposure to quizalofop-p

ethyl ester from food will utilize 19% of

the RfD for the highest exposed

population subgroup (non-nursing

infants <1 year 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. Because there are no

indoor or outdoor residential uses for

quizalofop-p ethyl, and the estimates of

quizalofop-p ethyl chronic residues in

drinking water are much less (estimated

at 8.08 ppb) than the 73 ppb concern

level, aggregate (food, water, and

residential) chronic exposure for

infants, children, and adults will not

exceed the Agency’s level of concern.

EPA concludes that there is a reasonable

certainty that no harm will result to

infants and children from aggregate

exposure to quizalofop-p ethyl ester

residues.

4. Short- or intermediate-term risk.

Because no toxicological endpoints have

been identified for short-, intermediate-

, and/or chronic-term dermal or

inhalation exposures, the Agency

believes there is reasonable certainty

that no harm will result from exposure

to quizalofop-p ethyl due to approved

tolerances.

III. Other Considerations

A. Metabolism In Plants and Animals

The Agency has previously concluded

that the nature of the quizalofop-p ethyl

residue in plants is adequately

understood. The residues of concern are

quizalofop-p ethyl ester and its acid

metabolite, quizalofop-p, and the S

enantiomers of both the ester and the

acid, all expressed as quizalofop-p (40

CFR 180.441(c)). In animals, the

residues of concern are slightly different

and include quizalofop ethyl,

quizalofop methyl, and quizalofop acid,

all expressed as quizalofop-ethyl (40

CFR 180.441(b)).

B. Analytical Enforcement Methodology

An adequate enforcement method for

determination of quizalofop-p-ethyl and

related regulated residues is available in

PAM II.

C. Magnitude of Residues

The maximum residues detected on

fresh mint foliage at the proposed

labeled level of DuPont’s product,

Assure, of 0.2 pounds(lbs) active

ingredient(ai) per acre (1x) applied 30

days before harvest were 0.22, 0.46, and

1.0 ppm for Indiana, Oregon and

Washington, respectively. The largest

residue found on fresh mint foliage, 2.6

ppm, was detected in a Washington

sample treated with 0.4 lbs. per acre (2x)

29 days before harvest, twice the

maximum yearly rate allowed. At the

Level of Quantitation (LOQ) of 0.05

ppm, there were no detectable residues

in the mint oil, either at the proposed

label rate of 0.2 lbs. ai/acre(A), or at the

exaggerated rate of 0.4 lbs. ai/A,

indicating that quizalofop-p ethyl and

its acid metabolite are not concentrated

during the oil distillation process.

Adequate residue data were provided to

support a tolerance of 2.0 ppm for mint.

There are no livestock feedstuffs

associated with mint.

Adequate residue data were provided

to support proposed tolerances canola

seed and canola meal. Processing data

provided for canola seed indicated

concentration in canola meal. Based on

the concentration factor of 2.3x and the

highest average field trial (HAFT)

residue level of 0.65 ppm for canola

seed, a tolerance at 1.5 ppm for canola

meal is considered adequate.

Results of a ruminant feeding study

lead to the conclusion that the

established quizalofop and quizalofop-p

ethyl tolerance in milk, and in fat, meat,

and meat by-products of cattle, goats,

hogs, horse, and sheep are adequate and

need not be increased from the

additional use on canola. Additionally,

the established tolerances of quizalofop

and quizalofop-p ethyl in eggs, and in

fat, meat, and meat by-products of

poultry are adequate and need not be

changed from the additional use on

canola.

D. International Residue Limits

There are no Codex, Canadian, or

Mexican Maximum Residue Limits

(MRLs) for quizalofop-p ethyl residues

in/on mint. Since there are no Mexican

or Codex MRLs/tolerances for

quizalofop-p-ethyl in/on canola seed,

compatibility is not a problem at this

time. Compatibility cannot be achieved

with the Canadian negligible residue

types limit at 0.1 ppm as the U.S. use

pattern had findings of real residues

above 0.1 ppm. Additionally, the

Canadian MRL is in terms of parent

only, thus the tolerance expressions are

not compatible.

E. Rotational Crop Restrictions

Available data support a 120 day

plant back interval.

IV. Conclusion

Therefore, tolerances are established

for combined residues of quizalofop-p

ethyl ester [ethyl (R)-(2[4-((6-

chloroquinoxalin-2-yl)oxy)phenoxyl]-

propanoate), and its acid metabolite

quizalofop-p [R-(2-[4-((6-

chloroquinoxalin-2-

yl)oxy)phenoxyl)propionate and the S

enantiomers of the ester and the acid, all

expressed as quizalofop-p ethyl ester in

or on canola seed at 1.0 ppm, canola

meal at 1.5 ppm, and peppermint tops

and spearmint tops at 2.0 ppm.

V. 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 August 17, 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
Federal Register / Vol. 63, No. 115 /Tuesday, June 16, 1998 /Rules and Regulations 32759

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.

VI. Public Record and Electronic

Submissions

EPA has established a record for this

rulemaking under docket control

number [OPP–300663] (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

Hwy., 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

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.

VII. Regulatory Assessment

Requirements

This final rule establishes tolerances

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) (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 on the

basis of a petition under FFDCA section

408(d), 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 actions published on May 4,

1981 (46 FR 24950) and was provided

to the Chief Counsel for Advocacy of the

Small Business Administration.

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 rule in

the Federal Register. This rule is not a

‘‘major rule’’ as defined by 5 U.S.C.

804(2).

List of Subjects

40 CFR Part 180

Environmental protection,

Administrative practice and procedure,

Agricultural commodities, Pesticides

and pests, Reporting and recordkeeping

requirements.

40 CFR Part 185

Environmental protection, Food

additives, Pesticides and pests.

40 CFR Part 186

Environmental protection, Animal

feeds, Pesticides and pests.

Dated: May 28, 1998.

Peter Caulkins,

Acting 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 180.441 is revised to read

as follows:

§ 180.441 Quizalofop ethyl; tolerances for

residues.

(a) General. (1) Tolerances are

established for the combined residues of

the herbicide quizalofop (2-[4-(6-

chloroquinoxalin-2-yl

oxy)phenoxy]propanoic acid) and

quizalofop ethyl (ethyl-2-[4-(6-

chloroquinoxalin-2-yl

oxy)phenoxy]propanoate), all expressed

as quizalofop ethyl, in or on the

following agricultural commodities:

Commodity Parts per

million

Soybean flour .............................. 0.5

Soybean hulls ............................. 0.02

Soybean meal ............................. 0.5

Soybean soapstock .................... 1.0

Soybeans .................................... 0.05
32760 Federal Register / Vol. 63, No. 115 /Tuesday, June 16, 1998 /Rules and Regulations

(2) Tolerances are established for the

combined residues of the herbicide

quizalofop (2-[4-(6-chloroquinoxalin-2-

yl oxy)phenoxy]propanoic acid),

quizalop-ethyl (ethyl-2-[4-(6-

chloroquinoxalin-2-yl

oxy)phenoxy]propanoate), and

quizalofop-methyl (methyl 2-[4-(6-

chloroquinoxalin-2-yloxy)phenoxy]propanoate, all expressed

as quizalofop ethyl, as follows:

Commodity Parts per

million

Cattle, fat .................................... 0.05

Cattle, meat ................................ 0.02

Cattle, mbyp ................................ 0.05

Eggs ............................................ 0.02

Goats, fat .................................... 0.05

Goats, meat ................................ 0.02

Goats, mbyp ............................... 0.05

Hogs, fat ..................................... 0.05

Hogs, meat ................................. 0.02

Hogs, mbyp ................................. 0.05

Horses, fat .................................. 0.05

Horses, meat .............................. 0.02

Horses, mbyp .............................. 0.05

Milk .............................................. 0.01

Milk, fat ....................................... 0.05

Poultry, fat ................................... 0.05

Poultry, meat ............................... 0.02

Poultry, mbyp .............................. 0.05

Sheep, fat ................................... 0.05

Sheep, meat ............................... 0.02

Sheep, mbyp ............................... 0.05

(3) Tolerances are established for the

combined residues of the herbicide

quizalofop-p ethyl ester [ethyl (R)-(2-[4-

((6-chloroquinoxalin-2-

yl)oxy)phenoxy)propanoate], and its

acid metabolite quizalofop-p [R-(2-(4-

((6-quinoxalin-2-

yl)oxy)phenoxy)propanoic acid], and

the S enantiomers of both the ester and

the acid, all expressed as quizalofop-pethyl ester, in or on the following raw

agricultural commodities;

Commodity Parts per

million

Canola, meal ............................... 1.5

Canola, seed ............................... 1.0

Cottonseed .................................. 0.1

Lentils .......................................... 0.05

Peppermint, tops ......................... 2.0

Spearmint, tops ........................... 2.0

(4) Time limited tolerances to expire

on June 14, 1999 are established for the

combined residues of the herbicide

quizalofop-p ethyl ester (ethyl (R)-(2-(4-

((6-chloroquinoxalin-2-

yl)oxy)phenoxy)propanoate) and it acid

metabolite quizalofop-p [R-(2-(4-((6-

chloroquinoxalin-2-

yl)oxy)phenoxy)propanoic acid), and

the S enantiomers of both the ester and

the acid, all expressed as quizalofop-pethyl ester in or on the following raw

agricultural commodities:

Commodities Parts per

million

Foliage of legume vegetables

(except soybeans) ................... 3.0

Legume vegetables (succulent or

dried) group ............................. 0.25

Sugarbeet molasses ................... 0.2

Sugarbeet, root ........................... 0.1

Sugarbeet, top ............................ 0.5

(b) Section 18 emergency exemptions.

[Reserved]

(c) Tolerances with regional

registrations. Tolerances with regional

registration, as defined in § 180.1(n), are

established for the combined residues of

the herbicide quizalofop-p ethyl ester

[ethyl (R)-2-[4-((6-chloroquinoxalin-2-

yl)oxy)phenoxy] propionate], its acid

metabolite quizalofop-p [R-(2-[4-((6-

chloroquinoxalin-2-yl)oxy)phenoxy])

propanoic acid], and the S enantiomers

of both the ester and the acid, all

expressed as quizalofop-p ethyl ester, in

or the raw agricultural commodities, as

follows:

Commodity Parts per

million

Pineapple .................................... 0.1

(d) Indirect or inadvertent residues.

[Reserved]

PART 185— [AMENDED]

3. In part 185:

a. The authority citation for part 185

continues to read as follows:

Authority: 21 U.S.C. 346a and 348.

§ 185.5250 [Removed]

b. Section § 185.5250 is removed.

PART 186— [AMENDED]

4. In part 186:

a. The authority citation for part 186

continues to read as follows:

Authority: 21 U.S.C. 342, 348, and 701.

§ 186.5250 [Removed]

b. Section § 186.5250 is removed.

[FR Doc. 98–15746 Filed 6–15–98; 8:45 am]

BILLING CODE 6560–50–F

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Part 300

[FRL–6111–2]

National Oil and Hazardous

Substances Pollution Contingency

Plan; National Priorities List Update

AGENCY: Environmental Protection

Agency.

ACTION: Notice of deletion of the

Southern Shipbuilding Corporation

Superfund site from the National

Priorities List.

SUMMARY: The Environmental Protection

Agency (EPA) Region 6 announces the

deletion of the Southern Shipbuilding

Corporation Superfund Site (the ‘‘Site’’)

from the National Priorities List (NPL).

The NPL, promulgated pursuant to

section 105 of the Comprehensive

Environmental Response,

Compensation, and Liability Act

(CERCLA) of 1980, as amended, is

codified at Appendix B to the National

Oil and Hazardous Substances Pollution

Contingency Plan (NCP), 40 CFR Part

300. EPA in consultation with the State

of Louisiana, through the Louisiana

Department of Environmental Quality

(LDEQ), has determined that no further

response is appropriate since all

federally funded actions specified in the

Record of Decision for Operable Units

One (1) and Two (2) have been

implemented. Consequently, the Site is

hereby deleted from the NPL.

EFFECTIVE DATE: June 16, 1998.

ADDRESSES: Comprehensive information

on the Site has been compiled in a

public deletion docket which may be

reviewed and copied during normal

business hours at the following

Southern Shipbuilding Corporation

Superfund Site information repositories:

U.S. EPA Region 6 Library (12th Floor),

1445 Ross Avenue, Dallas, Texas

75202–2733, 1–800–533–3508.

St. Tammany Parish Public Library,

Slidell Branch, 555 Robert Blvd.,

Slidell, Louisiana 70450, (504) 643–

4120.

FOR FURTHER INFORMATION CONTACT:

Mr. Mark A. Hansen, Remedial Project

Manager (6SF–LT), U.S.

Environmental Protection Agency,

Region 6 1445 Ross Avenue, Dallas,

Texas 75202–2733, (214) 665–7548

or

Mr. Duane Wilson, Louisiana

Department of Environmental Quality,

7290 Bluebonnet Road, Baton Rouge,

Louisiana 70809, (504) 765–0487.

SUPPLEMENTARY INFORMATION: The site to

be deleted from the NPL is the Southern

Shipbuilding Corporation Superfund

Site, Slidell, St. Tammany Parish,

Louisiana (EPA Site Spill No. 066Z;

CERCLIS No. LAD008149015). A Notice

of Intent to Delete (NOID) was

published on March 31, 1998 (63 FR

15346). The closing date for public

comment on the NOID was April 30,

1998. EPA received no public comments

and therefore, no Responsiveness

Summary was prepared.

The EPA identifies sites which appear

to present a significant risk to public

health, welfare, or the environment and