38644 Federal Register / Vol. 63, No. 137 / Friday, July 17, 1998 / Notices

EIS No. 980264, Draft EIS, NOA, FL,

Guana, Tolomato, Matanizas, Site

Designation, National Estuarine

Research Reserve, Management Plan,

City of Jacksonville, St. Johns and

Flagler Counties, FL, Due: August 31,

1998. Contact: Stephanie Thornton

(301) 713–3125.

EIS No. 980265, Draft EIS, AFS, VT,

Mount Snow/Haystack Resort,

Expansion of Snowmaking Coverage

and Development of Alternative

Water Supplies, Special-Use-Permit

and COE Section 404 Permit, Green

Mountain National Forest,

Manchester Ranger District, Windham

County, VT, Due: August 31, 1998.

Contact: Nancy Burt (802) 747–6742.

EIS No. 980266, Draft EIS, UAF, NM,

University of New Mexico (UNM),

Construction of the Enchanted Skies

Park and Observatory on Horace Mesa

near Grants, Cibola County, NM, Due:

August 31, 1998. Contact: Julia

Cantrell (210) 536–3515.

EIS No. 980268, Draft Supplement, AFS,

AZ, Grand Canyon/Tusayan Growth

Area Improvements, Updated

Information on three New

Alternatives, General Management

Plan (GMP), Special-Use-Permit, Land

Exchange Options, Approval and

Licenses Issuance, Coconino County,

AZ, Due: September 02, 1998.

Contact: R. Dennis Lund (520) 635–

8200.

Dated: July 14, 1998.

William D. Dickerson,

Director, NEPA Compliance Division, Office

of Federal Activities.

[FR Doc. 98–19120 Filed 7–16–98; 8:45 am]

BILLING CODE 6560–50–U

ENVIRONMENTAL PROTECTION

AGENCY

[PF–820; FRL–6019–1]

BASF Corporation; Pesticide

Tolerance Petition Filing

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Notice.

SUMMARY: This notice announces the

initial filing of a pesticide petition

proposing the establishment of

regulations for residues of a certain

pesticide chemical in or on various food

commodities.

DATES: Comments, identified by the

docket control number PF–820, must be

received on or before August 17, 1998.

ADDRESSES: By mail submit written

comments to: Information and Records

Integrity Branch, Public Information and

Services Divison (7502C), Office of

Pesticides Programs, Environmental

Protection Agency, 401 M St., SW.,

Washington, DC 20460. In person bring

comments to: Rm. 119, CM #2, 1921

Jefferson Davis Highway, Arlington, VA.

Comments and data may also be

submitted electronically by following

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. 119 at the address

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

Monday through Friday, excluding legal

holidays.

FOR FURTHER INFORMATION CONTACT: Beth

Edwards, Insecticide Branch,

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:

Rm. 206, Crystal Mall #2, 1921 Jefferson

Davis Highway, Arlington, VA 22202,

(703) 305–5400; e-mail:

edwards.beth@epamail.epa.gov.

SUPPLEMENTARY INFORMATION: EPA has

received a pesticide petition as follows

proposing the establishment and/or

amendment of regulations for residues

of certain pesticide chemical 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 this petition

contains 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–820]

(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. Comment and data will

also be accepted on disks in

Wordperfect 5.1/6.1 file format or ASCII

file format. All comments and data in

electronic form must be identified by

the docket control number (PF–820) and

appropriate petition number. Electronic

comments on this notice may be filed

online at many Federal Depository

Libraries.

List of Subjects

Environmental protection,

Agricultural commodities, Feed

additives, Food additives, Pesticides

and pests, Reporting and recordkeeping

requirements.

Dated: July 13, 1998.

James Jones,

Director, Registration Division, Office of

Pesticide Programs.

Summary of Petition

The petitioner summary of the

pesticide petition is printed below as

required by section 408(d)(3) of the

FFDCA. The summary of the petition

was prepared by the petitioner and

represents the views of the petitioner.

EPA is publishing the petition summary

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.

BASF Corporation

PP 4E4411

EPA has received a pesticide petition

(PP 4E4411) from BASF Corporation,

Agricultural Products, P.O. Box 13528,

Research Triangle Park, NC 27709

proposing pursuant to section 408(d) of

the Federal Food, Drug, and Cosmetic

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

180.448 by establishing a tolerance for

residues of hexythiazox [trans-5-(4-

chlorophenyl)-N-cyclohexyl-4-methyl-2-

oxothiazolidine-3-carboxamide] and its

metabolites containing the (4-

chlorophenyl)-4-methyl-2-oxo-3-
Federal Register / Vol. 63, No. 137 / Friday, July 17, 1998 / Notices 38645

thiazolidine moiety (expressed as parts

per million (ppm) of the parent

compound), in or on the raw

agricultural commodity dried hops. The

proposed analytical method is gas

chromatography using Nitrogen

Phosphorous detection. 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 and animal metabolism.

BASF Corporation notes that

metabolism in plants and animals is

understood.

2. Analytical method. The proposed

analytical method involves methanol

extraction, clean-up by partition, and

detection of residues by gc with npd.

3. Magnitude of residues. Nine

residue trials were conducted in Bavaria

Germany. The method of detection had

a limit of detection of 0.05 ppm. After

kiln drying, hops residues ranged from

0.61 to 1.53 ppm and averaged

approximately 0.9 ppm.

B. Toxicological Profile

1. Acute toxicity. For the technical

grade active ingredient:

Acute oral toxicity—Rat. LD50 >5,000

milligram/killograms (mg/kg) (Tox

Category IV); Acute Dermal Toxicity

(rat) LD50 > 5,000 mg/kg (Tox Category

III); Acute Inhalation Toxicity (rat) LC50

> 2.0 mg/l (4 hrs) (Tox Category IV);

Primary Eye Irritation (rabbit) -

Hexythiazox is a mild ocular irritant

(Tox Category III); Primary Dermal

irritation (rabbit) - Hexythiazox is not a

dermal irritant (Tox Category IV);

Dermal Sensitization (guinea pig) -

Hexythiazox is not a dermal sensitizer.

2. Genotoxicty. All mutagenicity tests

were negative. Ames Testing. Negative

(Accession No. 072941). In vitro

cytogenicity (Chinese hamster ovary

cells): Negative (MRID 00156894). Rat

primary hepatocyte unscheduled DNA

synthesis assay (MRID 00156893).

Mammalian cell forward gene mutation

assay (MRID 00155154).

3. Reproductive and developmental

toxicity—i. Developmental toxicity—

Rat. The maternal toxicity NOEL was

determined to be 240 mg/kg/day. The

fetotoxicity NOEL was 240 mg/kg/day,

and the compound was not embryotoxic

at the highest dose tested (HDT), 2,160

mg/kg/day (MRID 00147578).

ii. Developmental toxicity— Rabbit.

No development or maternal toxicity

was observed at the HDT, 1,080 mg/kg/

day (MRID 00146555).

iii. Multi-generation reproduction—

Rat. The parental toxicity NOEL was

determined to be 20 mg/kg/day. No

reproductive effects were observed at

2,400 ppm (200 mg/kg/day), the HDT.

4. Chronic toxicity. The data

submitted in support of this tolerance

and other relevant material have been

reviewed. The toxicological and

metabolism data considered in support

of this tolerance are discussed in detail

in related documents published in the

Federal Registers of April 26, 1989 (54

FR 17947), and February 21, 1996 (61

FR 6552) (FRL-5350-6) .

5. Chronic toxicity non-rodent—Dog

and rodent—Rat. The NOEL for chronic

effects for hexythiazox is 2.5 mg/kg/day,

based upon a 1-year dog study, and the

RfD is 0.025 mg/kg/day (MRID

00146556, 00151359, and 00156895). A

2-year rat study showed a systemic

NOEL of 430 ppm (21.5 mg/kg/day,

MRID 00146559). No evidence of

oncogenicity was observed in this study.

6. Oncogenicity in the rodent—

Mouse. Hexythiazox produced an

oncogenic effect in the livers of female

mice (MRID 00147577, 00156896,

40328701, and 40328702) with a

systemic NOEL of 250 ppm (37.5 mg/kg/

day). The Agency has calculated an

oncogenic potential of Q* = 0.039 (mg/

kg/day)-1.

7. Hormonal effects. No specific

hormonal effects testing has been

conducted with hexythiazox, however,

the compound was tested in two

developmental bioassays and a multigeneration reproduction bioassay. No

hormonal effects were noted in these

relevant tests.

8. Threshold effects. A chronic dietary

exposure/risk assessment has been

performed for hexythiazox using the

established reference dose (RfD) of 0.025

mg/kg-bwt/day. The RfD was based on

a NOEL of 2.5 mg/kg/day from a 1-year

dog feeding study.

9. Non-threshold effects. The Agency

has classified hexythiazox as a class C

(possible human) carcinogen based on a

significantly increased incidence of

hepatocellular carcinomas (p=0.028),

and adenomas/carcinomas combined

(p=0.024) in female mice at the HDT

(1,500 ppm) when compared to the

controls as well as a significantly

increased (p> 0.001) incidence of

preneo-plastic hepatic nodules in both

males and females at the HDT (1,500

ppm). The decision supporting a

Category C classification (rather than a

Category B) was based primarily on the

fact that only one species was affected

(mouse), mutagenicity assays did not

support upgrading to a B classification,

and structure-activity relationship of

hexythiazox to other compounds

supported a C classification. In

classifying hexythiazox as a Category C

carcinogen, the Agency concluded that

a quantitative estimate of the

carcinogenic potential for humans

should be calculated because of the

increased incidence of malignant liver

tumors in the female mouse.

Thus, a Q* of 3.9 x 10-2 (mg/kg/day)-

1 in human equivalents has been

calculated. A full review of the data

indicates that although hexythiazox is a

carcinogen in mice, the risks would be

extremely small from the proposed use

on hops. Estimated dietary carcinogenic

risk to the general population based on

the highly conservative assumptions

that all imported hops are treated with

hexythiazox and would bear residues at

the proposed tolerance level is

estimated to be approximately 3 x10-7.

In fact, the Agency estimated in 1993,

that the most conservative estimate of

the percentage of beer containing

foreign grown hops (including imported

beer and domestic beer brewed with

imported hops) to be approximately

49%. In addition, the average residue

seen in the residue studies supporting

this tolerance was approximately 0.9

ppm. Incorporating this information

into the risk calculation the estimated

oncogenic risk from the proposed use is

reduced to approximately 7 x 10-8. Even

this is an overestimation, as the

calculations assume that the level of

hexythiazox in finished beer is the same

as the level in the dried hops. BASF has

supplied information which

demonstrates that finished beer brewed

with hops containing an average level of

1.16 ppm results in hexythiazox levels

of <0.05 ppm in the finished beer.

Assuming a level of 0.05 ppm in beer

produced from hops would further

reduce the theoretical risk to

approximately 4 x 10-9.

A chronic dietary exposure/risk

assessment has been performed for

hexythiazox using a RfD of 0.025 mg/kgbwt/day. The RfD was based on a NOEL

of 2.5 mg/kg/day from a 1-year dog

feeding study and a safety factor of 100.

The endpoint effect of concern was

hypertrophy of the adrenal cortex in

both sexes, decreased red blood cell

counts, hemoglobin content and

hematocrit in males. The analysis was

performed using tolerance level residues

and 100% crop treated information. The

exposure for established tolerances and

the current proposal utilizes <1% of the

RfD for the U.S.population.

C. Aggregate Exposure

1. Dietary exposure. The exposure for

established tolerances and the current
38646 Federal Register / Vol. 63, No. 137 / Friday, July 17, 1998 / Notices

proposal utilizes <1% of the RfD for the

U.S. population. Non-nursing infants <l

represent the most exposed subpopulation and the percent of the RfD

consumed by this group is <3%. BASF

has estimated the theoretical oncogenic

risk for the currently registered uses of

hexythiazox (apples and pears) to be

approximately 1.5 x 10-6. This risk

number includes the very conservative

assumptions that all apples and pears

are treated with hexythiazox and that all

resulting residues are at the tolerance

level. In its recent FR Notice

establishing the tolerance in apples the

Agency recognized these conservative

overestimations and concluded ‘‘in

reality, the Agency knows that all

apples would not be treated with this

pesticide and expect that even apples

receiving maximum treatment will have

residues far below tolerance level. For

example, in field trials conducted using

application rates 10 times the label

amount, residues in apples still did not

exceed the tolerance level. Further, the

maximum residue level (MRL) in apple

juice would be expected to be less than

50% of the residue level in whole fruit.

Based on an assessment of the cancer

risks of the proposed use of

hexythiazox, the Agency believes that

the proposed use of hexythiazox on

apples will pose an extremely small risk

to humans.’’ The current proposal will

not increase the theoretical oncogenic

risk significantly.

In addition, the Agency has

concluded that based on the residue and

feeding levels of spent hops ‘‘meat and

milk tolerances are not required for this

petition.’’

2. ‘‘Other’’ exposure. Other potential

sources of exposure of the general

population to residues of pesticides are

residues in drinking water and exposure

from non-occupational sources. Since

this tolerance is for an ‘‘imported use,’’

BASF does not anticipate exposure to

residues of hexythiazox in drinking

water. BASF has not estimated nonoccupational exposure for hexythiazox.

Since the current registrations for

hexythiazox in the United States are

limited to commercial apple/pear

production, the potential for nonoccupational exposure to the general

population is considered to be

insignificant.

D. Cumulative Effects

BASF also considered the potential

for cumulative effects of hexythiazox

and other substances that have a

common mechanism of toxicity. BASF

is unaware of any conclusive data

regarding the potential for hexythiazox

to share a common mechanism for toxic

effects with any other compound. In

dietary assessment, the food factor for

hops is only 0.03%. Therefore, BASF

concluded that any concern regarding a

common mechanism of toxicity would

be insignificant.

E. Safety Determination

1. U.S. population. Using the

exposure assumptions described above,

BASF concludes that aggregate exposure

to hexythiazox will utilize

approximately <1% of the RfD for the

U.S. population. EPA generally has no

concern for exposures below 100% of

the RfD. In addition the calculated

theoretical oncogenic risk associated

with this use is more than 100 times less

than the Agency’s general level of

concern (1 x 10-6).

Therefore, based on the completeness

and reliability of the toxicity data and

the conservative exposure assessment,

BASF concludes that there is a

reasonable certainty that no harm will

result from aggregate exposure to

residues of hexythiazox, including all

anticipated dietary exposure and all

other non-occupational exposures.

2. Infants and children. The toxicity

database includes both developmental

and reproductive testing in which no

significant concerns were identified.

BASF therefore believes the established

RfD of 0.025 mg/kg/day is the

appropriate approach for assessing risk

in children. Based on the completeness

and reliability of the toxicity data and

the conservative exposure assessment,

BASF concludes that there is a

reasonable certainty that no harm will

result to infants and children from

aggregate exposure to the residues of

hexythiazox, including all anticipated

dietary exposure and all other nonoccupational exposures.

F. Other Considerations

The qualitative nature of the residues

in plants and animals is adequately

understood. There is a practical

analytical method for detecting and

measuring levels of hexythiazox in or on

food with a limit of detection that

allows monitoring of food with residues

at or above the levels set in these

tolerances.

G. International Tolerances

A maximum residue level has not

been established for hexythiazox by the

Codex Alimentarius Commission.

[FR Doc. 98–19247 Filed 7–16–98; 8:45 am]

BILLING CODE 6560–50–F

ENVIRONMENTAL PROTECTION

AGENCY

[FRL–6126–2]

Report on the Shrimp Virus Peer

Review Workshop

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Notice of availability of a draft

final report.

SUMMARY: This document announces the

availability of a draft final report of a

peer review and risk assessment

workshop, sponsored by the U.S.

Environmental Protection Agency

(EPA), National Center for

Environmental Assessment, on behalf of

the Joint Subcommittee on Aquaculture

(JSA), National Science and Technology

Council, held January 7–8, 1998. The

report entitled, ‘‘Report on the Shrimp

Virus Peer Review and Risk Assessment

Workshop: Developing a Qualitative

Risk Assessment’’ (EPA/630/R–98/

001A), was completed under contract to

the EPA. It develops a qualitative

ecological risk assessment describing

the potential risks of nonindigenous

pathogenic shrimp viruses on wild

shrimp populations in U.S. coastal

waters. Expert conclusions and

recommendations contained in the

report are currently undergoing an

independent scientific review. The

results of this independent review and

the draft final report will be used as the

basis for a risk management workshop

on shrimp viruses scheduled for July

28–29, 1998 in New Orleans (see 63 FR

36895–36896 (July 8, 1998)).

DATES: The report will be available on

or about July 24, 1998.

ADDRESSES: An electronic version of the

draft final report will be accessible on

the EPA National Center for

Environmental Assessment home page

at http://www.epa.gov/ncea/.

FOR FURTHER INFORMATION CONTACT: Dr.

H. Kay Austin, U.S. Environmental

Protection Agency, Office of Research

and Development, National Center for

Environmental Assessment (8601D), 401

M Street, SW, Washington, DC 20460;

telephone (202) 564–3328; fax: (202)

565–0066; e-mail austin.kay@epa.gov.

For technical assistance contact Dr. Tom

McIlwain, Chairperson of the JSA

Shrimp Virus Work Group, National

Marine Fisheries Service, 3209

Frederick Street, Pascagoula, MS 39567,

(601) 762–4591.

SUPPLEMENTARY INFORMATION: Public

concerns over the potential introduction

and spread of nonindigenous

pathogenic shrimp viruses to the wild

shrimp fishery and shrimp aquaculture