Federal Register / Vol. 63, No. 144 /Tuesday, July 28, 1998 / Notices 40273

Name Case No.

Ben Salamoni Trucking Service Inc ............................................................................................................................................. RK272–01697

Clarke Oil Well Servicing Inc ....................................................................................................................................................... RK272–01871

Excel Specialty Products .............................................................................................................................................................. RK272–04762

Leggett & Platt, Incorporated ....................................................................................................................................................... RF272–4705

National Beverages, Inc. .............................................................................................................................................................. RK272–04677

Personnel Security Hearing ......................................................................................................................................................... VSO–0206

Petrolane Gas Service Ltd. Partnership ...................................................................................................................................... RF340–00169

Texaco Refining and Marketing, Inc. ........................................................................................................................................... RR340–0001

The Brindle Excavating Co., Inc. ................................................................................................................................................. RK272–01477

Weinberg Chemical & Supply Company ...................................................................................................................................... RK272–04716

200 Varick Street Associates ....................................................................................................................................................... RK272–04603

[FR Doc. 98–20128 Filed 7–27–98; 8:45 am]

BILLING CODE 6450–01–P

ENVIRONMENTAL PROTECTION

AGENCY

[PF–816; FRL–5799–3]

Notice of Filing of Pesticide Petitions

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Notice.

SUMMARY: This notice announces the

initial filing of pesticide petitions

proposing the establishment of

regulations for residues of certain

pesticide chemicals in or on various

food commodities.

DATES: Comments, identified by the

docket control number PF–816, must be

received on or before August 27, 1998.

ADDRESSES: By mail submit written

comments to: Public Information and

Records Integrity Branch, Information

Resources and Services Division

(7502C), Office of Pesticides Programs,

Environmental Protection Agency, 401

M St., SW., Washington, DC 20460. In

person bring comments to: Rm. 1132,

CM #2, 1921 Jefferson Davis Highway,

Arlington, VA.

Comments and data may also be

submitted electronically to: oppdocket@epamail.epa.gov. Follow the

instructions under ‘‘SUPPLEMENTARY

INFORMATION.’’ No confidential

business information should be

submitted through e-mail.

Information submitted as a comment

concerning this document may be

claimed confidential by marking any

part or all of that information as

‘‘Confidential Business Information’’

(CBI). CBI should not be submitted

through e-mail. Information marked as

CBI will not be disclosed except in

accordance with procedures set forth in

40 CFR part 2. A copy of the comment

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. All written

comments will be available for public

inspection in Rm. 1132 at the address

given above, from 8:30 a.m. to 4 p.m.,

Monday through Friday, excluding legal

holidays.

FOR FURTHER INFORMATION CONTACT: The

product manager listed in the table

below:

Product Manager Office location/telephone number Address

Bipin Gandhi (PM 21) .... Rm. 707A, CM #2, 703–308–8380, e-mail:gandhi.bipin@epamail.epa.gov. 1921 Jefferson Davis Hwy, Arlington, VA.

Cynthia Giles-Parker

(PM 22).

Rm. 247, CM #2, 703–305–7740, e-mail:giles-parker@epamail.epa.gov. 1921 Jefferson Davis

Hwy.,Arlington, VA.

SUPPLEMENTARY INFORMATION: EPA has

received pesticide petitions as follows

proposing the establishment and/or

amendment of regulations for residues

of certain pesticide chemicals in or on

various food commodities under section

408 of the Federal Food, Drug, and

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

EPA has determined that these petitions

contain data or information regarding

the elements set forth in section

408(d)(2); however, EPA has not fully

evaluated the sufficiency of the

submitted data at this time or whether

the data supports granting of the

petition. Additional data may be needed

before EPA rules on the petition.

The official record for this notice of

filing, as well as the public version, has

been established for this notice of filing

under docket control number [PF–816]

(including comments and data

submitted electronically as described

below). 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 official

record is located at the address in

‘‘ADDRESSES’’ at the beginning of this

document.

Electronic comments can 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. Comments and data will

also be accepted on disks in

Wordperfect 5.1 file format or ASCII file

format. All comments and data in

electronic form must be identified by

the docket number (insert docket

number) and appropriate petition

number. Electronic comments on notice

may be filed online at many Federal

Depository Libraries.

List of Subjects

Environmental protection,

Agricultural commodities, Food

additives, Feed additives, Pesticides and

pests, Reporting and recordkeeping

requirements.

Dated:July 9, 1998.

James Jones,

Director, Registration Division, Office of

Pesticide Programs.

Summaries of Petitions

Petitioner summaries of the pesticide

petitions are printed below as required

by section 408(d)(3) of the FFDCA. The

summaries of the petitions were

prepared by the petitioners and
40274 Federal Register / Vol. 63, No. 144 /Tuesday, July 28, 1998 / Notices

represent the views of the petitioners.

EPA is publishing the petition

summaries verbatim without editing

them in any way. The petition summary

announces the availability of a

description of the analytical methods

available to EPA for the detection and

measurement of the pesticide chemical

residues or an explanation of why no

such method is needed.

1. Fleming Laboratories, Inc.

PP 4G4276

EPA has received a pesticide petition

(PP 4G4276) from Fleming Laboratories,

Inc., P.O.Box 34384, Charlotte, NC

28234 proposing pursuant to section

408(d) of the Federal Food, Drug, and

Cosmetic Act, 21 U.S.C. 346a(d), to

amend 40 CFR part 180 by establishing

a tolerance for residues of (4-

methylphenyl)arsonic acid in or on the

raw agricultural commodity fresh

market grapefruit grown only in Florida

at 0.5 parts per million (ppm). EPA has

determined that the petition contains

data or information regarding the

elements set forth in section 408(d)(2) of

the FFDCA; however, EPA has not fully

evaluated the sufficiency of the

submitted data at this time or whether

the data supports granting of the

petition. Additional data may be needed

before EPA rules on the petition.

A. Residue Chemistry

1. Plant metabolism. A plant

metabolism study is being conducted at

the proposed use rate of 6.22 lbs active

ingredient (6.25 lbs product) per acre

and has revealed approximately 0.46

ppm total radioactive residue (TRR) in

whole fruit, of which 0.13 ppm or

29.2% of the TRR was parent

compound. Four of the 11 metabolites

isolated from whole fruit exceed 10% of

the TRR. Metabolite characterization

and identification is still in progress.

2. Analytical method. A High

Performance Liquid Chromatography

(HPLC) method is available to verify the

certified limits of arsanilic acid in the

end-use product.

Currently there is no validated

method for determining any of the

residues of arsanilic acid in/on

grapefruit. However, method

development is partially complete for an

analytical method to determine residues

of (4-aminophenyl)arsonic acid, per se,

the active ingredient of Pro-Gen(r), in or

on whole grapefruit. In principle, a 50

gram sample of grapefruit is extracted

by homogenization with water. The

extract is centrifuged, filtered,

concentrated by rotary evaporation,

cleaned up on a florisil column,

buffered to pH 4.5, then derivatized

with methyl thioglycolate. The

derivative is partitioned into toluene,

which is analyzed by gas

chromatography (GC) and an electron

capture detector (ECD). The anticipated

Limit of Quantitation (LOQ) is 0.05

ppm. Method development for the

metabolite residues will ensue as the

metabolites are identified.

3. Magnitude of residues. Field

residue trials are currently in progress at

several sites in Florida. Mature

grapefruit samples have been harvested

from trees treated with 6.25 lbs ProGen(r) per acre and are being stored

until residue analytical method

development is complete. However,

based on the data from the plant

metabolism study, total residues of

arsanilic acid in grapefruit are expected

to be less than 0.5 ppm.

B. Toxicological Profile

1. Acute toxicity. Pro-Gen(r)/arsanilic

acid is only moderately acutely toxic to

mammals. The rat acute oral LD50 values

were 1,411 mg/kg for males, 976 (646-

2883) mg/kg for females and 1,461 mg/

kg for males and females combined. A

study with New Zealand white rabbits

established acute dermal LD50 values of

922 mg/kg for males, 909 (445-1972)

mg/kg for females and 921 (577-1402)

mg/kg for males and females combined.

Arsanilic acid has caused minimal signs

of toxicity in rats following a 4 hour

inhalation exposure to a measured

atmospheric concentration of 5.35 mg/l.

The acute inhalation LC50 is greater than

5.35 mg/l. Arsanilic acid is slightly

irritant to rabbit eyes and is not irritant

to rabbit skin.

Arsanilic acid is not considered a skin

sensitizer. Arsanilic acid does not cause

sensitization in guinea pigs.

Additionally, arsanilic acid has been

manufactured and used since the 1940’s

as a medicinal feed additive for poultry

and swine with no reported incidents of

hypersensitivity among workers.

2. Genotoxicty. Arsanilic acid is not

mutagenic to five strains of Salmonella

typhimurium. In the mouse

micronucleus test, arsanilic acid (99.6%

purity) was devoid of micronucleus

inducing potential in the bone marrow

of male and female CD-1 mice when

tested to maximum tolerated doses.

Arsanilic acid was determined to be

weakly mutagenic in mouse lymphoma

L51178Y cells in the presence of S9

mix, when tested at concentrations

extending into the toxic range. However,

evidence of mutagenicity in the absence

of S9 mix was inconclusive.

3. Reproductive and developmental

toxicity. A review of three studies

detailing the effects of arsanilic acid on

reproduction in swine found no adverse

effects on the fertility, fecundity, or

health and survival of swine dams and

their offspring at an arsanilic acid feed

concentration of 100 ppm. Furthermore,

at the 100 ppm arsanilic acid feeding

level, no gross abnormalities or adverse

effects were found on organ weights or

pathology. To the contrary, arsanilic

acid in the diet improved the overall

health, improved weight gain, and

increased survival of swine.

No developmental effects were found

in rats exposed in utero to arsanilic acid

at levels up to and including that which

produced overt maternal toxicity.

Arsanilic acid was administered orally

by gavage to pregnant rats at nominal

dose levels of up to 60 mg/kg/day.

Reduced body weight gains early in the

treatment period, reduced food

consumption, and the presence clinical

signs (60 mg/kg/day group) were

considered evidence of maternal

toxicity. No developmental toxicity was

apparent at any dose level. A no

observable effect level (NOEL) for

maternal effects (reduced food

consumption) was considered to be less

than 6 mg/kg/day (based on a 60.0% of

target concentration analysis of the 10

mg/kg/day formulation used during the

first 5 days of dose administration). The

NOEL for maternal clinical signs was 30

mg/kg/day. The NOEL for

developmental toxicity of rats was 60

mg/kg/day.

No developmental effects were noted

in rabbits exposed in utero to arsanilic

acid (100%) at levels up to and

including that which produced overt

maternal toxicity. Arsanilic acid (ProGen(r)) was administered orally by

gavage to pregnant rabbits at nominal

dose levels up to 6 mg/kg/day. Maternal

effects were observed only in the 6 mg/

kg/day dosed dams and were limited to

reductions in mean body weight gain

and food consumption. No maternal

effects were apparent at dose levels of

1 and 3 mg/kg/day. No developmental

toxicity was expressed at any dose level.

The NOEL for maternal effects was 3

mg/kg/day. The NOEL for

developmental toxicity was 6 mg/kg/

day.

4. Subchronic toxicity. No mortality

occurred during a 91-day feeding study

in which male and female rats were fed

nominal concentrations of up to 750

ppm arsanilic acid in the diet. Some

signs of toxicity (behavior, locomotion

and excreta) were observed at feeding

levels of 375 ppm and above. No

definite treatment effects were observed

in animals receiving 50 ppm arsanilic

acid in the diet. The NOEL was

determined to be 50 ppm (3.77 mg/kg/

day for males and 4.76 mg/kg/day for

females).
Federal Register / Vol. 63, No. 144 /Tuesday, July 28, 1998 / Notices 40275

No mortality occurred during a 90-day

feeding study in which male and female

beagles were fed arsanilic acid at up to

200 ppm in diet. No ophthalmoscopic

abnormalities were observed at any

level. Clinical signs of toxicity were

observed in some dogs receiving 200

ppm arsanilic acid in diet. While there

was no observable indication of toxicity

in animals receiving up to 100 ppm

arsanilic acid in the diet, microscopic

evaluation of the kidneys revealed doserelated abnormalities. The NOEL for

female beagle dogs was 50 ppm (1.7 mg/

kg/day). The NOEL for male beagle dogs

was 25 ppm (0.7 mg/kg/day).

5. Chronic toxicity. Arsanilic acid is

not carcinogenic to rats. Arsanilic acid

is approved by the FDA for use as a

medicinal feed supplement for swine

and poultry at concentrations up to

0.01% of the ration and has been

extensively used in commercial rations

since the 1940’s.

Arsanilic acid was fed to rats (two

separate studies) at concentration levels

of 100, 500 and 1,000 ppm in the diet

for 106 to 116-weeks. In both studies,

the presence of arsanilic acid in the diet

was reported to have caused no gross

abnormalities or adverse effects on

organ weights, pathology, incidence of

tumors or health of rats.

Long term feeding of 0.01% arsanilic

acid in pig feed for up to 51 months

during a multigeneration study resulted

in increased survival and overall

improved health of arsanilic acidtreated pigs.

6. Animal metabolism. Arsanilic acid

uniformly labeled with 14C in the

benzene ring was used to determine the

metabolic fate of arsanilic acid fed to

pigs and chickens. Arsanilic acid was

well absorbed by both species. Urine

was the predominant route of excretion.

The bile was a minor (<5% of the dose)

route of excretion in pigs (was not

measured in chickens). Arsanilic acid

and two other metabolites, Nacetylarsanilic acid and (4-

acetamidophenyl)dimethylarsine oxide,

were identified in the pig urine. In pigs,

somewhere between 17-39% of the

urinary 14C metabolites was excreted as

arsanilic acid, 15-29% as Nacetylarsanilic acid and <5% as (4-

acetamidophenyl)dimethylarsine oxide.

Only 2-5% of the radio-labeled arsanilic

acid dose remained in the carcass or

liver of pigs while less than 1%

remained in the chicken carcasses (liver

included). There was no evidence of any

biotransformation of arsanilic acid in

chickens. The study authors also note

that the results of this study corroborate

earlier research showing that chickens

rapidly excrete arsanilic acid with no

biotransformation.

7. Metabolite toxicology. There is no

known information about the toxicity of

any of the currently identified

metabolites of arsanilic acid.

8. Endocrine disruption. Arsanilic

acid is not considered to be an

endocrine disruptor. Several studies in

which different species were

administered high levels of arsanilic

acid have shown no effect on the timeto-mating or on mating and fertility

indices. Radiolabelled [14C]-arsanilic

acid fed to chickens (laying hens) had

no effect on the ability of the hens to

produce eggs. Multigeneration

reproduction studies in swine,

developmental toxicity studies in rats

and rabbits, chronic studies in rats plus

long term medicinal use in animal

husbandry amply demonstrates that

arsanilic acid does not affect the estrous

cycle, mating behavior, male or female

fertility, or male or female reproductive

tracts.

C. Aggregate Exposure

1. Dietary exposure—Food— i. From

medicinal feed additive use. Arsanilic

acid has been utilized under FDA

approval as a medicinal feed additive in

pig, chicken and turkey feeds since the

1940’s. However, the feed additive

tolerances established by the FDA are

expressed in terms of total residues of

combined arsenic (calculated as As)

instead of as arsanilic acid (21 CFR

558.62 and 556.60). Because arsanilic

acid may be the sole dietary contributor

that necessitates the feed additive

tolerances for arsenic, these tolerances

can be converted to total arsanilic acid

equivalents by using a conversion factor

of 2.9, the ratio of the molecular weight

of arsanilic acid (217.04) to that of its

arsenic content (74.92).

Total Residues as Arsenic (ppm)

Total Residues as

Arsanilic Acid

(ppm)

Commodity

0.5 .................................................................................................................................. 1.45 eggs, chicken

0.5 .................................................................................................................................. 1.45 muscle, chicken

2.0 .................................................................................................................................. 5.8 edible by-products, chicken

0.5 .................................................................................................................................. 1.45 eggs, turkey

0.5 .................................................................................................................................. 1.45 muscle, turkey

2.0 .................................................................................................................................. 5.8 edible by-products, turkey

2.0 .................................................................................................................................. 5.8 liver, swine

2.0 .................................................................................................................................. 5,8 kidney, swine

0.5 .................................................................................................................................. 1.45 muscle, swine

0.5 .................................................................................................................................. 1.45 by-products, swine

ii. From proposed use on fresh market

grapefruit grown only in Florida. In the

amended petition for a Saleable

Experimental Use Permit, the following

temporary tolerance is proposed for

total residues of arsanilic acid expressed

as arsanilic acid, per se, in or on fresh

market grapefruit.

0.5 ppm in/on grapefruit (whole fruit)

Because the treated fruit are

prohibited from being processed under

the amended Experimental Use Permit,

no dietary exposure is anticipated from

the processed commodities nor are any

temporary tolerances proposed for the

processed commodities, grapefruit juice,

dried grapefruit pulp or grapefruit citrus

oil.

iii. From livestock consumption of

treated grapefruit and/or processed

products. Under the amended petition

for Experimental Use Permits (EUP),

treated fruit may not be fed to livestock.

The amended EUP also restricts

livestock grazing or consumption of

forage or hay from Pro-Gen(r) treated

orchards. Therefore, no dietary exposure

to arsanilic acid is anticipated from

livestock consumption of Pro-Gen(r)

under the auspices of the proposed EUP.

2. Drinking water. No exposure to

arsanilic acid is expected from

consumption of drinking water.

Arsanilic acid is not proposed for

application to sources of drinking water.

Additionally, hydrolysis, soil

metabolism and soil adsorption/

desorption studies have shown that

arsanilic acid is stable to environmental

degradation and binds tightly and

irreversibly to the organic and mineral

fractions of soils. Any arsanilic acid that
40276 Federal Register / Vol. 63, No. 144 /Tuesday, July 28, 1998 / Notices

might be excreted by poultry or swine

administered arsanilic acid for

medicinal purposes will be tightly

bound to soil if incorporated in to the

soil as a fertilizer. Consequently,

potential exposure of surface and/or

ground water to arsanilic acid will be

minimized.

3. Non-dietary exposure. There are no

known sources of non-dietary exposure

to arsanilic acid, outside of occupational

exposure in the manufacturing and

packaging of Pro-Gen(r)/arsanilic acid in

its current usage in animal husbandry,

or in its proposed use in Florida fresh

market grapefruit production. There is

little concern that children would be

exposed to non-dietary sources of

arsanilic acid.

D. Cumulative Effects

For cumulative exposure

considerations, Fleming Laboratories

believes it is appropriate to consider

only the potential risks of arsanilic acid

noted in the discussion of aggregate

exposure (above), based on the current

approaches used by the FDA and EPA

for regulating organic arsenical

compounds in animal husbandry and

crop production.

Arsanilic acid is an organic arsenical

compound. FDA regulations have

established feed additive tolerances,

expressed as ppm total combined

arsenic, for the following medicinal

organoarsenical compounds, arsanilic

acid, arsanilate sodium, nitarsone,

carbarsone, and roxarsone.

Although FDA has authorized the use

of these compounds as medicinal feed

additives, only one of these

organoarsenicals may be used at a time

as the sole source of organic arsenic in

the feed. Therefore, there is no exposure

from multiple organic arsenicals in

animal feeds.

With regards to crop protection, the

only known organic arsenicals

registered in the U.S. are the herbicides:

cacodylic acid, a cotton defoliant; and

disodium or monosodium

methanearsonic acid, contact herbicides

used in cotton and citrus production.

With regard to residue tolerances for

these herbicides, residues of cacodylic

acid are regulated discretely for that

compound under 40 CFR 180.311.

While, residues of disodium and

monosodium methanearsonic acid are

regulated simultaneously as

methanearsonic acid under 40 CFR

180.289. Since these compounds are

regulated discretely, it can be assumed

that EPA considers them to have

distinct metabolic pathways and modes

of action.

Since arsanilic acid has a

considerably different chemical

structure (containing a phenyl ring)

from these other straight-chained

organic arsenical herbicides, it is

reasonable to assume that arsanilic acid

will have a unique mode of action

compared to the straight chain

herbicides. The proposed use of

arsanilic acid as a plant growth

regulator further illustrates the

differences when comparing arsanilic

acid to these herbicides.

Therefore, for cumulative exposure

considerations, Fleming Laboratories

believes it is appropriate to consider

only the potential risks of arsanilic acid

noted in the discussion of aggregate

exposure (above).

E. Safety Determination

U.S. population. The Acceptable

Daily Intake (ADI) is the amount of

pesticide residue that can be ‘‘safely’’

ingested by humans and still be

protective of the health of all segments

of the population. An ADI must be

established for any pesticide that results

in a residue on crops used for human

consumption. The ADI, sometimes

referred to as the Reference Dose (RfD),

is a mathematically derived figure based

on the NOEL of a chronic or subchronic

toxicity study and safety or uncertainty

factors. Uncertainty factors are used to

compensate for inter- and intra-species

differences, type of study, etc. when

extrapolating from toxicity data (animal

or human) to human risk assessments.

For arsanilic acid, the ADI will be

based on the results of the dog

subchronic feeding study. The ADI is

equal to the NOEL times a safety or

uncertainty factor (UF). It is customary

to use a UF of 100 fold (100x) to account

for the species differences from dog to

human, as well as for extrapolating from

a subchronic study to chronic exposure

of humans. Assuming that EPA concurs

with an uncertainty factor of 100x, the

ADI based on the most sensitive NOEL

can be calculated as follows:

NOEL = 25 ppm arsanilic acid in diet

of dogs = 0.75 mg/kg/day

Then the ADI or RfD = 0.75 mg/kg/

day x (1/100) = 0.0075 mg/kg/day

Based on EPA’s total diet survey,

sensitive populations, such as infants,

have little or no intake of grapefruit or

grapefruit juice. Therefore the ADI is

based on consumption of grapefruit and

grapefruit juice by 70 kg adult humans.

Therefore, if the ADI is 0.0075 mg/kg/

day, a 70 kg adult could safely consume

0.525 mg arsanilic acid /day (0.0075 mg/

kg/day x 70 kg).

F. Dietary Risk Assessment

The dietary risk assessment evaluates

how much of the ADI would be ‘‘used

up’’ when residue tolerances are

proposed for pesticide-bearing crop or

animal commodities that may be

consumed by humans. To conduct the

risk assessment for arsanilic acid under

the tenets of the proposed amended

Experimental Use Permit for Floridagrown, fresh market fruit only, one

needs to know how much grapefruit

would typically be consumed by

humans and the amount of arsanilic

acid residues in or on the fruit.

Additionally, human exposure from

consumption of swine and poultry

products from medicinally treated

animals must be considered.

For estimating grapefruit dietary

consumption, EPA’s Total Diet Study,

which is used to calculate exposure and

dietary risk for pesticides, reveals that

25-30 year-old men have the highest

consumption of grapefruit compared to

all other age and sex groupings.

Consumption rates in this group are

listed as 4.3 grams of grapefruit per day.

Consumption of whole grapefruit (4.3

grams/day) contributes to less than

0.08% of the total diet in this age and

sex category.

Dietary exposure from grapefruit

consumption will be reduced by the

limited use of Pro-Gen(r) to grapefruit

grown in Florida. According to the

Florida Citrus Summary 1993-94,

Florida produced 816,800 tons of

grapefruit in 1993-1994, which was

66.10% of the total U.S. production of

grapefruit. This means that grapefruit

grown in Florida would contribute to

less than 0.053% (i.e. 0.08% of diet x

66.1% of grapefruit = 0.053%) of the

total diet for the highest consumers of

grapefruit, 25-30 year-old men.

For estimating the dietary

consumption of swine and poultry

products, EPA’s Total Diet Study reveals

that 25-30 year-old men have the

highest consumption of pork (39.5

grams/day) and poultry (chicken plus

turkey; 28.7 grams/day). (Gram servings

of pork, chicken and turkey kidneys and

livers were not included). While 60-65

year old men have the highest

consumption of eggs, the 25-30 year-old

men have the second highest

consumption rate (31 grams/day). Total

consumption of pork, poultry and eggs

accounts for 3.23% of the diet of 25-20

year-old men. In comparison, the same

commodities comprise 3.1% of the diet

of 2 year-old children, 2.7 % for females

14-16 years-old, 2.9% for males 14-16

years-old and 2.8% for 25-30 year-old

women.

For conducting a dietary risk

assessment and to provide conservative

estimates: (1) the total consumption of

fruit has been adjusted up from an

estimated 4.3 grams to 5 grams

grapefruit consumed per day (2); total
Federal Register / Vol. 63, No. 144 /Tuesday, July 28, 1998 / Notices 40277

residues of arsanilic acid in or on whole

fruit are considered to be 0.5 ppm,

based on the proposed temporary

tolerance for total residues of Pro-Gen(r)

in or on treated grapefruit (3); the total

consumption of pork, poultry and eggs

has been adjusted from the estimated

39.5 grams/day to 40 grams/day; and (4)

total FDA allowed residues of arsanilic

acid in pork or poultry products (with

the exception of kidneys and liver) is

1.45 ppm. Since the estimated gram

quantities of pork and poultry organ

meats (kidneys and livers) were not

provided using the estimated daily

consumption of 2.8 g beef liver provides

an extremely conservative estimate for

pork and poultry livers with FDA

allowed arsanilic acid residues of 5.8

ppm.

If it is assumed that all grapefruit in

Florida are treated with Pro-Gen(r),

which results in total arsanilic acid

residue levels of 0.5 ppm in fruit, and

a 70 kg adult consumes 5 grams of

grapefruit per day of which 66.1% is

from Florida, then the total dietary

intake per day can be calculated as

follows:

5 grams/day grapefruit consumed =

0.005 kg/day grapefruit consumed

0.005 kg/day grapefruit x 0.661 =

0.00331 kg/day Florida fresh market

grapefruit consumed

Total residues of 0.5 ppm arsanilic

acid = 0.5 mg total arsanilic acid

residues /kg food

(Amount of Florida fruit consumed) x

(residue level) = 0.00331 kg fruit/day x

0.5 mg total arsanilic acid residues /kg

fruit = 0.00166 mg total arsanilic acid/

day in grapefruit

If it is assumed that all swine and

poultry received arsanilic acid-treated,

then the total dietary intake per day of

arsanilic acid from pork and poultry

products except organ meats, can be

calculated as follows:

40 grams/day pork, poultry and eggs

consumed = 0.04 kg/day animal

products consumed

X total residues of 1.45 ppm arsanilic

acid = 1.45 mg total arsanilic acid

residues /kg food

(Amount of pork, poultry and eggs

consumed) x (residue level) = 0.04 kg/

day x 1.45 mg total arsanilic acid

residues /kg food = 0.058 mg total

arsanilic acid/day in pork, poultry and

eggs.

If it is assumed that all swine and

poultry received arsanilic acid-treated,

then the total dietary intake per day of

arsanilic acid from pork and poultry

kidneys and liver can be calculated as

follows:

2.8 grams/day pork and poultry

organs consumed = 0.0028 kg/day

organs consumed

Total residues of 5.8 ppm arsanilic

acid = 5.8 mg total arsanilic acid

residues /kg food

(Amount of kidneys and liver

consumed) x (residue level) = 0.0028 kg

total arsanilic acid /day x 5.8 mg/kg =

0.016 mg total arsanilic acid/day in pork

and poultry kidneys and liver.

Total dietary intake of total arsanilic

acid = 0.00166 + 0.058 + 0.016 =

0.07566 mg total arsanilic acid residues

per day

This estimate of total dietary intake

represents only 14% of the allowable

daily consumption of 0.525 mg arsanilic

acid/day for a 70 kg adult, established

by a NOEL of 25 ppm and an ADI of

0.0075 mg/kg/day. The estimated

dietary intake of total arsanilic acid

residues from Pro-Gen(r)-treated fresh

market grapefruit is only 0.03% of the

ADI of 0.0075 mg/kg/day.

Infants and children. Based on EPA’s

total diet survey, sensitive populations,

such as infants, have little or no intake

of grapefruit or grapefruit juice.

Therefore, the proposed use of ProGen(r) on Florida grapefruit will pose no

additional risk of adverse effects to

infants or children beyond that which

already exists from consumption of

poultry and swine products from

animals medicinally treated with

arsanilic acid. Even so, it is appropriate

to consider the results of the

developmental, reproductive, and

chronic studies. The available data

clearly show that there is no increased

risk to neonates or young when arsanilic

acid is ingested. Therefore, Fleming

Laboratories concludes that

An additional safety factor for the

protection of infants and children is not

needed and

The ADI or RfD of 0.0075 mg/kg/day

is appropriate for assessing arsanilic

acid risks to infants and children.

G. International Tolerances

The Applicant is not aware of any

international tolerances or Codes

Maximum Residue Limits (MRLs) for

arsanilic acid on any crop or livestock

commodities. (Cynthia Giles-Parker)

2. ICI Surfactants

PP 8E4965

EPA has received a pesticide petition

(PP 8E4965) from ICI Surfactants, 3411

Silverside Road, Wilmington, DE,

proposing pursuant to section 408(d) of

the Federal Food, Drug, and Cosmetic

Act, 21 U.S.C. 346a(d), to amend 40 CFR

180.1001(c) and (e) to establish an

exemption from the requirement of a

tolerance for oxirane, methyl-, polymer

with oxirane, mono[2-(2-

butoxyethoxy)ethyl]ether (CAS Registry

No. 85637-75-8) when used as an inert

ingredient in pesticide formulations

applied to growing crops or to raw

agricultural commodities after harvest

or to animals. EPA has determined that

the petition contains data or information

regarding the elements set forth in

section 408(d)(2) of the FFDCA;

however, EPA has not fully evaluated

the sufficiency of the submitted data at

this time or whether the data supports

granting of the petition. Additional data

may be needed before EPA rules on the

petition.

A. Residue Chemistry

Magnitude of residues. No residue

chemistry data or environmental fate

data are presented in the petition as the

Agency does not generally require some

or all of the listed studies to rule on the

exemption from the requirement of a

tolerance for an inert ingredient.

B. Toxicological Profile

1. Acute toxicity. ICI believes

sufficient information was submitted in

the petition to assess the hazards of

oxirane, methyl-,polymer with oxirane,

mono[2-(2-butoxyethoxy)ethyl]ether. No

toxicology data were presented in the

petition as the Agency does not

generally require some or all of the

listed studies to rule on the exemption

from the requirement of a tolerance for

an inert ingredient. Based on this

polymer conforming to the definition of

a polymer and meeting the criteria of a

polymer under 40 CFR 723.250 ICI

believes there are no concerns for risks

associated with toxicity.

2. Endocrine disruption. ICI has no

information to suggest that oxirane,

methyl-, polymer with oxirane, mono[2-

(2- butoxyethoxy)ethyl]ether will have

an effect on the immune and endocrine

systems. EPA is not requiring

information on the endocrine effects of

this substance at this time; Congress has

allowed 3-years after August 3, 1996, for

the Agency to implement a screening

program with respect to endocrine

effects.

C. Cumulative Effects

ICI believes sufficient information

was submitted in the petition to assess

the hazards of oxirane, methyl-,polymer

with oxirane, mono[2-(2-

butoxyethoxy)ethyl]ether. Based on this

polymer conforming to the definition of

a polymer and meeting the criteria of a

polymer under 40 CFR 723.250 ICI

believes there are no concerns for risks

associated with cumulative effects.

D. Safety Determination

1. U.S. population. ICI believes

sufficient information was submitted in
40278 Federal Register / Vol. 63, No. 144 /Tuesday, July 28, 1998 / Notices

the petition to assess the hazards of

oxirane, methyl-,polymer with oxirane,

mono[2-(2-butoxyethoxy)ethyl]ether.

Based on this polymer conforming to

the definition of a polymer and meeting

the criteria of a polymer under 40 CFR

723.250 ICI believes there are no

concerns for risks associated with any

potential exposure to adults.

2. Infants and children. ICI believes

sufficient information was submitted in

the petition to assess the hazards of

oxirane, methyl-,polymer with oxirane,

mono[2-(2-butoxyethoxy)ethyl]ether.

Based on this polymer conforming to

the definition of a polymer and meeting

the criteria of a polymer under 40 CFR

723.250 ICI believes there are no

concerns for risks associated with any

potential exposure to infants and

children. (Bipin Gandhi)

3. KIM-C1, LLC

PP 7G4906

EPA has received a pesticide petition

(PP 7G4906) from KIM-C1, LLC, 6333

East Liberty Avenue, Fresno, CA 93727

proposing pursuant to section 408(d) of

the Federal Food, Drug, and Cosmetic

Act, 21 U.S.C. 346a(d), to amend 40 CFR

part 180 by establishing a tolerance for

residues of N-(2-chloro-4-pyridinyl)-Nphenylurea in or on the raw agricultural

commodities grape, kiwi, almond,

apple, blueberries, cranberries, figs,

plums, pears, and olives at 0.01 parts

per million (ppm). EPA has determined

that the petition contains data or

information regarding the elements set

forth in section 408(d)(2) of the FFDCA;

however, EPA has not fully evaluated

the sufficiency of the submitted data at

this time or whether the data supports

granting of the petition. Additional data

may be needed before EPA rules on the

petition.

A. Residue Chemistry

1. Plant metabolism. The qualitative

nature of the residues of CPPU in

almonds, apples, blueberries,

cranberries, figs, grapes, kiwis, olives,

pears and plums are adequately

understood. Three 14C radiolabeled

plant metabolism studies conducted in

apples, grapes and kiwis shows CPPU

leaves the same residue pattern in all

three crops, representing three unrelated

botanical species. These studies show

that the residue is in the low parts per

billion (ppb) range at harvest and that

the residue is primarily associated with

the skin. CPPU does not translocate any

significant distance in the plant, not

moving from the leaves to the fruit nor

from the fruit to the leaves. The use

level of 10 to 20 grams of CPPU per acre

assures that only low residues will

occur. Residue analysis on grapes and

kiwis confirm the radiolabel findings. In

grapes and kiwis the residue level was

below the level of quantification (LOQ)

in all cases and generally below the

level of validated detection. The LOQ in

whole grape was 0.01 ppm; the level of

detection (LOD) was 0.003 ppm. In

grape juice, the LOQ was 0.002 ppm and

the LOD was 0.0007 ppm (0.7 ppb). In

raisins the LOQ was 0.01 ppm and the

LOD was 0.003 ppm.

2. Analytical method. The analytical

method extracted the parent material

and analyzed it using HPLC analysis

with UV fluorescence at wavelength 265

nm.

3. Magnitude of residues. The

magnitude of the residues in the crops

are anticipated to be below the level of

quantification which, based on whole

fruit, will be 0.01 ppm.

B. Toxicological Profile

1. Acute toxicity. Based on EPA

criteria, CPPU would be placed in EPA

toxicity Category III generally, while the

dermal irritation results would be

placed in EPA Category IV.

Acute Oral 81-1 LD50 4.9 gr/kg

Acute Dermal 81-2 LD50 >2000 mg/

kg

Acute Inhalation 81-3 LC50 >3.0 mg/l

(the higest

conc achievable)

Eye Irritation 81-4 Mildly irritating;

No corneal or

iridial irritation

noted

Dermal Irritation 81-5 Non-irritating

Skin Sensitization 81-6 Non-sensitizing

2. Genotoxicity. The results from a

battery of three genetic toxicity tests

with CPPU show that this compound is

not mutagenic or genotoxic.

Gene mutation - Ames: Slightly

Positive

In-vivo structural chromosomal

aberration assay: Negative

In-vivo micronucleus aberration assay:

Negative

3. Reproductive and developmental

toxicity. Results of these studies

indicate that CPPU is not a reproductive

toxicant, developmental toxicant, or a

teratogen.

Teratology in rats: NOAEL (maternal)

= 100 mg/kg/day; no observed adverse

effect level (NOAEL) (fetal/

development) = 200 mg/kg/day

Teratology in rabbits: NOAEL

(maternal) = 25 mg/kg/day; NOAEL

(fetal/development) = 100 mg/kg/day

2-Generation reproduction in rats:

NOAEL (parental) = 150 ppm; NOAEL

(reproductive) = 2,000 ppm (115 mg/kg/

day - males) (205 mg/kg/day - females).

4. Subchronic toxicity. No treatmentrelated adverse effects were noted in

subchronic toxicity studies at the

highest doses tested.

28 - Day dietary in rats: NOEL 1,000

ppm

13 - Week dietary in rats: NOEL 200

ppm

28 - Day dietary in dogs: NOEL 2,500

ppm

13 - Week Dietary in dogs: NOAEL

500 ppm 13 - Week dietary in mice:

NOAEL 3,500 ppm.

5. Chronic toxicity 1-year chronic

toxicity in dogs: not required for EUP;

Test initiated.

18 -month chronic toxicity and

carconogeniscity in mice: not required

for EUP will be initiated section 3 reg.

24-month chronic toxicity and

carcinogenicity in rats: NOAEL 150 ppm

(8 mg/kg/day); NOAEL 7,500 ppm (435

mg/kg/day).

6. Animal metabolism. Study will be

completed prior to section 3 registration

requirement. (Not required for an

Experiment Use Permit.)

7. Metabolite toxicology. Metabolites

occur at levels below 0.1 ppm and

therefore are below levels required to be

assayed in animal testing. The 14C

radiolabel plant studies show

metabolites to be glucosides of the

parent material.

8. Endocrine disruption. Collective

weights and histopathological findings

from the 2-generation rat reproductive

study, as well as from the subchronic
Federal Register / Vol. 63, No. 144 /Tuesday, July 28, 1998 / Notices 40279

and chronic toxicity studies in two or

more animal species, demonstrate no

apparent effects on the endocrine

system. There is no information

available which suggests that CPPU

would be associated with endocrine

effects.

C. Aggregate Exposure

1. Dietary exposure—Food. A

reference dose (RfD) was calculated

using the most sensitive species data

available from the toxicological testing.

This RfD 0.08 mg/kg/day/based on a

temporary tolerance of 0.01 ppm, was

used to calculate the impact of the

estimated residue levels with results

from treatment of the indicated crops.

The table below shows the Theoretical

Maximum Residue Concentrations

(TMRC) of CPPU on or in the listed

crops requested in this EUP request.

Theoretical Maximum Residue

Concentrations for CPPU for the crops

listed in the EUP request.

All-Apples All+Apples

Total Exposure

mg/kg body wt/

day Percent of RfD

General U.S. Populations, all seasons .................................... 0.000005 0.000011 0.000016 0.02

Non-nursing infants .................................................................. 0.000029 0.000064 0.000093 0.12

Children 1 to 6-years of age .................................................... 0.000010 0.000048 0.000058 0.07

Children 7 to 12-years of age .................................................. 0.000005 0.000017 0.000022 0.03

The anticipated use rate of 17 grams

of CPPU per acre applied once per year

yielding residue levels in the very low

ppb range indicates that less than 1% of

the reference dose would be consumed

in aggregate with all of these crops. The

crop contributing greatest to the percent

of the reference dose related to the most

sensitive of the population i.e. all

nursing infants (less than 1-year old),

non-nursing infants (less than 1-year

old), children (1 to 6 years old) would

represent 1/10th of 1% of the reference

dose. Making the same risk exposure

calculations, it is shown that no

significant impact on reducing the RfD

by using blueberries, cranberries,

cranberry juice, grapes-raisins, pears,

pears dried, cherries, cherries dried,

cherry juice, plums (Damsons), plums as

prunes (dried), plum/prune juice, figs,

kiwifruit, grapes-wine and sherry,

cranberry juice concentrate, pear nectar

in aggregate. Combining the RfD

consumption from the large group of

crops with that of the apples would

exceed 1% of the reference dose only

slightly if the total acreage of all of these

crops were treated. The intention of this

experimental use permit is not to treat

all of the various crops listed; the table

below shows the requested acreage of

each crop.

Crop Acreage

Requested

% Total

Acreage

Grape 3,500 0.53

Kiwi 1,000 14.08

Almond 50 0.01

Apple 50 0.14

Blueberries 50

Cranberries 50

Figs 50 0.40

Plums 50 0.03

Pears 50 0.15

Olives 50 0.05

This program would permit

development of requisite data to assure

safe and efficacious use and, yet, not

subject any segment of the public to a

health risk.

2. Dietary exposure - drinking water.

The very low use rate of CPPU i.e. 17

grams or less per acre, if used constantly

for 20-years, would apply only 3/4 of a

pound of CPPU per acre during that 20-

year period. Computer modeling, using

the conservative pesticide root zone

model (PRZM) means of analysis has

shown that no CPPU would reach

ground water, even in sandy loam soils.

The results of this risk analysis

supported an unambiguous conclusion

of ‘‘essentially zero risk to ground

water’’ even under reasonable worst

case assumptions. Concentrations are

not predicted to exceed 15 to 20 ppb of

CPPU in the soil in the upper soil

horizons, even following yearly

applications for as long as 30 years. No

secondary exposure is anticipated as a

result of contamination of drinking

water.

3. Non-dietary exposure. No nondietary exposure is expected since

CPPU is not anticipated to be found in

the drinking water. It does not

translocate in plants and thus secondary

exposure through plants growing in soil

receiving CPPU is not anticipated. The

extremely low application rates will not

result in significant buildup in the

environment.

D. Cumulative Effects

There are no cumulative effects

expected since CPPU is not taken up by

plants from the soil. It slowly degrades

to mineral end points. Its low use rate

is not conducive to buildup in the

environment.

E. Safety Determination

1. U.S. population. As pointed out

above in dietary exposure-food the

percentage of the reference dose

consumed by treating the subject crops

represents only slightly more than 1%

of the estimated safe level for the most

sensitive segment of the population,

non-nursing infants.

2. Infants and children. No

developmental, reproductive or

fetotoxic effects have been associated

with CPPU. The calculation of safety

margins with respect to these segments

of the population were taken into

consideration in the TMRC estimates

with respect to the risk associated with

the percentage of the reference dose

being consumed.

F. International Tolerances

There is no Codex maximum residue

level established for CPPU. However,

CPPU is registered for use on grapes and

other crops in Japan, Chile, Mexico, and

South Africa. (Cynthia Giles-Parker)

[FR Doc. 98–20145 Filed 7–27–98; 8:45 am]

BILLING CODE 6560–50–F

ENVIRONMENTAL PROTECTION

AGENCY

[FRL–6131–5]

Notice of Proposed NPDES General

Permit for Discharges From ReadyMixed Concrete Plants, Concrete

Products Plants and Their Associated

Facilities in Texas (TXG110000)

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Notice of draft NPDES general

permit.

SUMMARY: EPA Region 6 is proposing to

issue a general NPDES permit

authorizing discharges of facility waste

water and contact storm water from

ready-mixed concrete plants, concrete

products plants and their associated

facilities in Texas. This permit covers

facilities having Standard Industrial

Classification (SIC) Codes 3273