2612 Federal Register / Vol. 5, No. 11 / Tuesday, January 18, 2000 / Notices

Force was created to offer advice to the

Administrator on the long-term strategy

for the effluent guidelines program, and

particularly to provide

recommendations on a process for

expediting the promulgation of effluent

guidelines. The Task Force generally

does not discuss specific effluent

guideline regulations currently under

development.

The meeting is open to the public,

and limited seating for the public is

available on a first-come, first-served

basis. The public may submit written

comments to the Task Force regarding

improvements to the Effluent

Guidelines Program. Comments should

be sent to Beverly Randolph at the

above address. Comments submitted by

January 21, 2000 will be considered by

the Task Force at or subsequent to the

meeting.

Dated: January 11, 2000.

Geoffrey H. Grubbs,

Director, Office of Science and Technology.

[FR Doc. 00–1065 Filed 1–14–00; 8:45 am]

BILLING CODE 6560–50–P

ENVIRONMENTAL PROTECTION

AGENCY

[PF–913; FRL–6486–4]

Notice of Filing a Pesticide Petition to

Establish a Tolerance for Certain

Pesticide Chemicals in or on Food

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 docket

control number PF–913, must be

received on or before February 17, 2000.

ADDRESSES: Comments may be

submitted by mail, electronically, or in

person. Please follow the detailed

instructions for each method as

provided in Unit I.C. of the

‘‘SUPPLEMENTARY INFORMATION.’’

To ensure proper receipt by EPA, it is

imperative that you identify docket

control number PF–913 in the subject

line on the first page of your response.

FOR FURTHER INFORMATION CONTACT: By

mail: Shaja R. Brothers, Registration

Division (7505C), Office of Pesticide

Programs, Environmental Protection

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

DC 20460; telephone number: (703)

308–3194; e-mail address:

brothers.shaja@epa.gov.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

You may be affected by this action if

you are an agricultural producer, food

manufacturer or pesticide manufacturer.

Potentially affected categories and

entities may include, but are not limited

to:

CategoriesNAICS

codes

Examples of potentially affected entities

Industry 111 Crop production

112 Animal production

311 Food manufacturing

32532 Pesticide manufacturing

This listing is not intended to be

exhaustive, but rather provides a guide

for readers regarding entities likely to be

affected by this action. Other types of

entities not listed in the table could also

be affected. The North American

Industrial Classification System

(NAICS) codes have been provided to

assist you and others in determining

whether or not this action might apply

to certain entities. If you have questions

regarding the applicability of this action

to a particular entity, consult the person

listed under ‘‘FOR FURTHER

INFORMATION CONTACT.’’

B. How Can I Get Additional

Information, Including Copies of this

Document and Other Related

Documents?

1. Electronically. You may obtain

electronic copies of this document, and

certain other related documents that

might be available electronically, from

the EPA Internet Home Page at http://

www.epa.gov/. To access this

document, on the Home Page select

‘‘Laws and Regulations’’ and then look

up the entry for this document under

the ‘‘Federal Register--Environmental

Documents.’’ You can also go directly to

the Federal Register listings at http://

www.epa.gov/fedrgstr/.

2. In person. The Agency has

established an official record for this

action under docket control number PF–

913. The official record consists of the

documents specifically referenced in

this action, any public comments

received during an applicable comment

period, and other information related to

this action, including any information

claimed as confidential business

information (CBI). This official record

includes the documents that are

physically located in the docket, as well

as the documents that are referenced in

those documents. The public version of

the official record does not include any

information claimed as CBI. The public

version of the official record, which

includes printed, paper versions of any

electronic comments submitted during

an applicable comment period, is

available for inspection in the Public

Information and Records Integrity

Branch (PIRIB), Rm. 119, Crystal Mall 2

(CM 2), 1921 Jefferson Davis Highway,

Arlington, VA, from 8:30 a.m. to 4 p.m.,

Monday through Friday, excluding legal

holidays. The PIRIB telephone number

is (703) 305–5805.

C. How and to Whom Do I Submit

Comments?

You may submit comments through

the mail, in person, or electronically. To

ensure proper receipt by EPA, it is

imperative that you identify docket

control number PF–913 in the subject

line on the first page of your response.

1. By mail. Submit your comments to:

Public Information and Records

Integrity Branch (PIRIB), Information

Resources and Services Division

(7502C), Office of Pesticide Programs

(OPP), Environmental Protection

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

DC 20460.

2. In person or by courier. Deliver

your comments to: Public Information

and Records Integrity Branch (PIRIB),

Information Resources and Services

Division (7502C), Office of Pesticide

Programs (OPP), Environmental

Protection Agency, Rm. 119, CM 2, 1921

Jefferson Davis Highway, Arlington, VA.

The PIRIB is open from 8:30 a.m. to 4

p.m., Monday through Friday, excluding

legal holidays. The PIRIB telephone

number is (703) 305–5805.

3. Electronically. You may submit

your comments electronically by e-mail

to: ‘‘opp-docket@epa.gov,’’ or you can

submit a computer disk as described

above. Do not submit any information

electronically that you consider to be

CBI. Avoid the use of special characters

and any form of encryption. Electronic

submissions will be accepted in

Wordperfect 6.1/8.0 or ASCII file

format. All comments in electronic form

must be identified by docket control

number PF–913. Electronic comments

may also be filed online at many Federal

Depository Libraries.

D. How Should I Handle CBI That I

Want to Submit to the Agency?

Do not submit any information

electronically that you consider to be

CBI. You may claim information that

you submit to EPA in response to this

document as CBI by marking any part or

all of that information as CBI.

Information so marked will not be

Federal Register / Vol. 5, No. 11 / Tuesday, January 18, 2000 / Notices 2613

disclosed except in accordance with

procedures set forth in 40 CFR part 2.

In addition to one complete version of

the comment that includes any

information claimed as CBI, a copy of

the comment that does not contain the

information claimed as CBI must be

submitted for inclusion in the public

version of the official record.

Information not marked confidential

will be included in the public version

of the official record without prior

notice. If you have any questions about

CBI or the procedures for claiming CBI,

please consult the person identified

under ‘‘FOR FURTHER INFORMATION

CONTACT.’’

E. What Should I Consider as I Prepare

My Comments for EPA?

You may find the following

suggestions helpful for preparing your

comments:

1. Explain your views as clearly as

possible.

2. Describe any assumptions that you

used.

3. Provide copies of any technical

information and/or data you used that

support your views.

4. If you estimate potential burden or

costs, explain how you arrived at the

estimate that you provide.

5. Provide specific examples to

illustrate your concerns.

6. Make sure to submit your

comments by the deadline in this

notice.

7. To ensure proper receipt by EPA,

be sure to identify the docket control

number assigned to this action in the

subject line on the first page of your

response. You may also provide the

name, date, and Federal Register

citation.

II. What Action is the Agency Taking?

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 petitions. Additional data may be

needed before EPA rules on the petition.

List of Subjects

Environmental protection,

Agricultural commodities, Feed

additives, Food additives, Pesticides

and pests, Reporting and recordkeeping

requirements.

Dated: January 6, 2000.

James Jones,

Director, Registration Division, Office of

Pesticide Programs.

Summaries of Petitions

The 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 petitioner and

represents the view of the petitioners.

EPA is publishing the petition

summaries verbatim without editing

them in any way. The petition

summaries announce 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. Interregional Project Number 4

9E6012 and 9E6021

EPA has received pesticide petitions

(9E6012 and 9E6021) from the

Interregional Project Number 4 (IR-4),

New Jersey Agricultural Experiment

Station, Rutgers University, New

Brunswick, New Jersey 08903

proposing, pursuant to section 408(d) of

the Federal Food, Drug, and Cosmetic

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

amend 40 CFR part 180 by establishing

a tolerance for residues of sethoxydim

in or on the raw agricultural

commodities (RAC) pistachio and

safflower at 0.2 and 15 parts per million

(ppm). EPA has determined that the

petitions contain 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 support

granting of the petitions. Additional

data may be needed before EPA rules on

the petitions. This notice includes a

summary of petitions prepared by BASF

Corporation Agricultural Products, P.O.

Box 13528, Research Triangle Park, NC

27709.

A. Residue Chemistry

1. Plant metabolism. The qualitative

nature of the residues in plants is

adequately understood for the purposes

of registration.

2. Analytical method. Analytical

methods for detecting levels of

sethoxydim and its metabolites 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 were submitted to EPA. The

proposed analytical method involves

extraction, partition, and clean-up.

Samples are then analyzed by gas

chromatography with sulfur-specific

flame photometric detection. The limit

of quantitation is 0.05 ppm.

B. Toxicological Profile

1. Acute toxicity. Based on the

available acute toxicity data,

sethoxydim does not pose any acute

dietary risks. A summary of the acute

toxicity studies are as follows:

i. Acute oral toxicity— Rat. Toxicity

Category III; lethal dose (LD50) = 3,125

milligrams/kilograms (mg/kg) male,

2,676 mg/kg female respectively.

ii. Acute dermal toxicity— Rat.

Toxicity Category III; LD50 > 5,000 mg/

kg (male and female).

iii. Acute inhalation toxicity— Rat.

Toxicity Category III; lethal

concentration (LC50) (4–hour) = 6.03

milligram/liter (mg/L) (male), 6.28 mg/

L (female) respectively.

iv. Primary eye irritation— Rabbit.

Toxicity Category IV; no irritation.

v. Primary dermal irritation— Rabbit.

Toxicity Category IV; no irritation.

vi. Dermal sensitization— Guinea pig.

Waived because no sensitization was

seen in guinea pigs dosed with the enduse product poast 18% active ingredient

(a.i.).

2. Genotoxicity. Ames assays were

negative for gene mutation in

Salmonella typhimurium strains TA98,

TA100, TA1535, and TA 1537, with and

without metabolic activity. A Chinese

hamster bone marrow cytogenetic assay

was negative for structural chromosomal

aberrations at doses up to 5,000 mg/kg

in Chinese hamster bone marrow cells

in vivo. Recombinant assays and

forward mutations tests in Bacillus

subtilis, Escherichia coli, and S.

typhimurium were all negative for

genotoxic effects at concentrations of

greater than or equal to 100%.

3. Reproductive and developmental

toxicity. A developmental toxicity study

in rats fed dosages of 0, 50, 180, 650, or

1,000 mg/kg/day with a maternal no

observed adverse effect level (NOAEL)

of 180 mg/kg/day and a maternal lowest

observed adverse effect level (LOAEL) of

650 mg/kg/day (irregular gait, decreased

activity, excessive salivation, and

anogenital staining); and a

developmental NOAEL of 180 mg/kg/

day, and a developmental LOAEL of 650

mg/kg/day (21 to 22% decrease in fetal

weights, filamentous tail, and lack of

tail due to the absence of sacral and/or

caudal vertebrae, and delayed

ossification in the hyoids, vertebral

centrum and/or transverse processes,

sternebrae and/or metatarsals, and

pubes).

2614 Federal Register / Vol. 5, No. 11 / Tuesday, January 18, 2000 / Notices

A developmental toxicity study in

rabbits fed doses of 0, 80, 160, 320, or

400 mg/kg/day with a maternal NOAEL

of 320 mg/kg/day and a maternal

LOAEL of 400 mg/kg/day (37%

reduction in body weight gain without

significant differences in group mean

body weights and decreased food

consumption during dosing) and a

developmental NOAEL greater than 400

mg/kg/day highest dose tested (HDT).

A 2-generation reproduction study

with rats fed diets containing 0, 150,

600, or 3,000 ppm (approximately 0, 7.5,

30, and 150 mg/kg/day) with no

reproductive effects observed under the

conditions of the study.

4. Subchronic toxicity. A 21–day

dermal study in rabbits with a NOAEL

of > 1,000 mg/kg/day limit dose. The

only dose-related finding was slight

epidermal hyperplasia at the dosing site

in nearly all males and females dosed at

1,000 mg/kg/day. This was probably an

adaptive response.

5. Chronic toxicity. A summary of the

chronic toxicity studies are as follows:

i. A 1–year feeding study with dogs

fed diets containing 0, 8.86/9.41, 17.5/

19.9, and 110/129 mg/kg/day (males/

females) with a NOAEL of 8.86/9.41 mg/

kg/day (males/females) based on

equivocal anemia in male dogs at the

17.5-mg/kg/day dose level.

ii. A 2–year chronic feeding/

carcinogenicity study with mice fed

diets containing 0, 40, 120, 360, or 1,080

ppm (equivalent to 0, 6, 18, 54, and 162

mg/kg/day) with a systemic NOAEL of

120 ppm (18 mg/kg/day) based on nonneoplastic liver lesions in male mice at

the 360-ppm (54 mg/kg/day) dose level.

There were no carcinogenic effects

observed under the conditions of the

study. The maximum tolerated dose

(MTD) was not achieved in female mice.

iii. A 2–year chronic feeding/

carcinogenic study with rats fed diets

containing 0, 2, 6, or 18 mg/kg/day with

a systemic NOAEL greater than or equal

to 18 mg/kg/day HDT. There were no

carcinogenic effects observed under the

conditions of the study. This study was

reviewed under current guidelines and

was found to be unacceptable because

the doses used were insufficient to

induce a toxic response and an MTD

was not achieved.

A second chronic feeding/

carcinogenic study with rats fed diets

containing 0, 360, or 1,080 ppm

(equivalent to 18.2/23.0, and 55.9/71.8

mg/kg/day (males/females)). The dose

levels were too low to elicit a toxic

response in the test animals and failed

to achieve an MTD or define a LOAEL.

Slight decreases in body weights in rats

at the 1,080-ppm dose level, although

not biologically significant, support a

free-standing NOAEL of 1,080 ppm

(55.9/71.8 mg/kg/day (males/females)).

There were no carcinogenic effects

observed under the conditions of the

study.

6. Animal metabolism. In a rat

metabolism study, excretion was

extremely rapid and tissue

accumulation was negligible.

7. Metabolite toxicology. As a

condition to registration, BASF had

been asked to submit additional

toxicology studies for the hydroxymetabolites of sethoxydim. EPA agreed

with BASF’s recommendation to use the

most abundant metabolite, 5-OH-MSO2,

as surrogate for all metabolites. Based

on these data, it was concluded that the

toxicological potency of the plant

hydroxy-metabolites is likely to be equal

or less than that of the parent

compound. The tolerance expression for

sethoxydim and its metabolites

containing the 2-cyclohexen-1-one

moiety, measured as parent. Hence, the

hyrdroxy-metabolites are figured into all

tolerance calculations.

8. Endocrine disruption. No specific

tests have been performed with

sethoxydim to determine whether the

chemical may have an effect in humans

that is similar to an effect produced by

naturally-occurring estrogen or other

endocrine effects.

C. Aggregate Exposure

1. Dietary exposure—i. Food. For

purposes of assessing the potential

dietary exposure, BASF has estimated

aggregate exposure based on the

theoretical maximum residue

contribution (TMRC) from existing and

pending tolerances for sethoxydim. (The

TMRC is a ‘‘worst case’’ estimate of

dietary exposure since it is assumed that

100% of all crops for which tolerances

are established are treated and that

pesticide residues are at the tolerance

levels). The TMRC from existing

tolerances for the overall U.S.

population is estimated at

approximately 44% of the chronic

population adjusted dose (cPAD). BASF

estimates indicate that dietary exposure

will not exceed the cPAD for any

population subgroup for which EPA has

data. This exposure assessment relies on

very conservative assumptions 100% of

crops will contain sethoxydim residues

and those residues would be at the level

of the tolerance which results in an

overestimate of human exposure.

ii. Drinking water. Other potential

sources of exposure of the general

population to residues of pesticides are

residues in drinking water and exposure

from non-occupational sources. Based

on the available studies submitted to

EPA for assessment of environmental

risk, BASF does not anticipate exposure

to residues of sethoxydim in drinking

water. There is no established maximum

concentration level for residues of

sethoxydim in drinking water under the

Safe Drinking Water Act.

2. Non-dietary exposure. BASF has

not estimated non-occupational

exposure for sethoxydim. Sethoxydim is

labeled for use by homeowners on and

around the following use sites: flowers,

evergreens, shrubs, trees, fruits,

vegetables, ornamental groundcovers,

and bedding plants. Hence, the potential

for non-occupational exposure to the

general population exists. However,

these use sites do not appreciably

increase exposure. Protective clothing

requirements, including the use of

gloves, adequately protect homeowners

when applying the product. The

product may only be applied through

hose-end sprayers or tank sprayers as a

0.14% solution. Sethoxydim is not a

volatile compound so inhalation

exposure during and after application

would be negligible. Dermal exposure

would be minimal in light of the

protective clothing and the low

application rate. According to BASF,

post-treatment (re-entry) exposure

would be negligible for these use sites

as contact with treated surfaces would

be low. BASF concludes that the

potential for non-occupational exposure

to the general population is

insignificant.

D. Cumulative Effects

BASF also considered the potential

for cumulative effects of sethoxydim

and other substances that have a

common mechanism of toxicity. BASF

is aware of one other a.i. which is

structurally similar, clethodim.

However BASF believes that

consideration of a common mechanism

of toxicity is not appropriate at this

time. BASF does not have any reliable

information to indicate that toxic effects

produced by sethoxydim would be

cumulative with clethodim or any other

chemical; thus, BASF is considering

only the potential risks of sethoxydim in

its exposure assessment.

E. Safety Determination

1. U.S. population. Using the

conservative exposure assumptions

described above, BASF has estimated

that aggregate exposure to sethoxydim

will utilize 44% of the cPAD for the

U.S. population. EPA generally has no

concern for exposures below 100% of

the cPAD. 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

Federal Register / Vol. 5, No. 11 / Tuesday, January 18, 2000 / Notices 2615

no harm will result from aggregate

exposure to residues of sethoxydim,

including all anticipated dietary

exposure and all other non-occupational

exposures.

2. Infants and children—i.

Developmental toxicity. Developmental

toxicity was observed in a

developmental toxicity study using rats

but was not seen in a developmental

toxicity study using rabbits. In the

developmental toxicity study in rats a

maternal NOAEL of 180 mg/kg/day and

a maternal LOAEL of 650 mg/kg/day

(irregular gait, decreased activity,

excessive salivation, and anogenital

staining) was determined. A

developmental NOAEL of 180 mg/kg/

day and a developmental LOAEL of 650

mg/kg/day (21 to 22% decrease in fetal

weights, filamentous tail and lack of tail

due to the absence of sacral and/or

caudal vertebrae, and delayed

ossification in the hyoids, vertebral

centrum and/or transverse processes,

sternebrae and/or metatarsals, and

pubes). Since developmental effects

were observed only at doses where

maternal toxicity was noted, the

developmental effects observed are

believed to be secondary effects

resulting from maternal stress.

ii. Reproductive toxicity. A 2-

generation reproduction study with rats

fed diets containing 0, 150, 600, or 3,000

ppm (approximately 0, 7.5, 30, and 150

mg/kg/day) produced no reproductive

effects during the course of the study.

Although the dose levels were

insufficient to elicit a toxic response,

the registrant has considered this study

usable for regulatory purposes and has

established a free-standing NOAEL of

3,000 ppm (approximately 150 mg/kg/

day).

iii. Chronic population adjusted dose.

Based on the demonstrated lack of

significant developmental or

reproductive toxicity, BASF believes

that the cPAD used to assess safety to

children should be the same as that for

the general population, 0.09 mg/kg/day.

Using the conservative exposure

assumptions described above, BASF has

concluded that the most sensitive child

population is that of children ages 1 to

6 years old. BASF calculates the

exposure to this group to be

approximately 95% of the cPAD for all

uses (including those proposed in this

document). 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

sethoxydim, including all anticipated

dietary exposure and all other nonoccupational exposures.

F. International Tolerances

A maximum residue level has not

been established for sethoxydim on

pistachio and safflower by the Codex

Alimentarius Commission.

2. Interregional Research Project

Number 4

9E6059

EPA has received a pesticide petition

(9E6059) from the Interregional

Research Project Number 4 (IR-4), New

Jersey Agricultural Experiment Station,

P. O. Box 231 Rutgers University, New

Brunswick, NJ 08903 proposing,

pursuant to section 408(d) of the

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

CFR part 180 by establishing a tolerance

for residues of prometryn in or on the

raw agricultural commodity cilantro at

0.1 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 support

granting of the petition. Additional data

may be needed before EPA rules on the

petition. This notice includes a

summary of the petition prepared by IR4.

A. Residue Chemistry

1. Plant metabolism. The metabolism

of prometryn in plants is adequately

understood for purposes of this

tolerance.

2. Analytical method. Method, gas

chromatography is available in PAM

Vol. II for plants to enforce the tolerance

expression.

3. Magnitude of residues. The nature

of the residue in plants is adequately

understood for the purposes of this

tolerance. Secondary residues in animal

commodities are not expected to exceed

existing tolerances as result of this use.

B. Toxicological Profile

1. Acute toxicity. A rat acute oral

study with a LD50 of 1,802 mg/kg for

males and a LD50 of 2,076 mg/kg for

females.

2. Genotoxicity. An Ames salmonella

test, prometryn was negative for gene

mutation up to cytotoxic solubility

limits (1,000-2,000 μg/plate). A

chromosomal aberration in vivo Chinese

hamster bone marrow test, prometryn

was negative for nuclear anomalies

(micronuclei) when animals were dosed

orally up to 5,000 mg/kg. Prometryn was

negative for bacterial DNA repair and

gene mutation up to precipitating levels

(1,000 μg/plate). In an unscheduled

DNA synthesis test, prometryn was

negative (measured as UDS) in rat

hepatocytes cultured in vitro up to

cytotoxic levels (156.25 μg/mL).

3. Reproductive and developmental

toxicity. A developmental toxicity study

in rats with a maternal and

developmental NOAEL of 50 mg/kg and

a maternal LOAEL of 250 mg/kg based

on salivation and decreases in body

weight and food consumption. The

developmental LOAEL is 250 mg/kg/day

based on significantly decreased and

incomplete ossification in the sternebrae

and metacarpals. A developmental

toxicity study in rabbits with a maternal

and developmental NOAEL of 12 mg/

kg/day and a maternal LOAEL of 72 mg/

kg based on decreased food

consumption, and the developmental

LOAEL of 72 mg/kg/day, based on

increased fetal resorption.

A 2–generation reproduction study in

rats with a parental systemic NOAEL of

0.6 mg/kg/day in males and 0.7 mg/kg/

day in females and a parental systemic

LOAEL of 47.8 mg/kg/day in males and

53.6 mg/kg/day in females based on

decreased food consumption, body

weight and body weight gain. The

reproductive systemic NOAEL is 0.65

mg/kg/day and the reproductive

systemic LOAEL is approximately 50

mg/kg/day, based on decreased pup

weight.

4. Subchronic toxicity. A 28–day mice

pilot feeding study with a NOAEL of

450 mg/kg/day and a LOAEL of 1,500

mg/kg/day based on decreased body

weights.

5. Chronic toxicity. A 102–week

chronic feeding/carcinogenicity study in

mice with a systemic NOAEL of 100 mg/

kg/day for females and a systemic

LOAEL of 300 mg/kg/day for females

based on decreased body weight gain.

No effects were observed in males.

A 2–year rat chronic feeding/

carcinogenicity study with a systemic

NOAEL of 29.45 mg/kg/day for males

and 37.25 mg/kg/day for females and a

systemic LOAEL of 60.88 mg/kg/day for

males and 80.62 mg/kg/day for females

based on decreased body weight and

body weight gain and an increase in the

incidence of renal lesions (mineralized

concretions) in males. Prometryn was

not carcinogenic under the conditions of

the study.

6. Animal metabolism. The

metabolism of prometryn in animals is

adequately understood for purposes of

this tolerance.

7. Metabolite toxicology. Rat

metabolism studies showed that radio

labeled prometryn is distributed in

blood greater than spleen greater than

lungs (the three highest tissues

measured). Distribution is not dosageVerDate 04<JAN>2000 23:09 Jan 14, 2000 Jkt 190000 PO 00000 Frm 00041 Fmt 4703 Sfmt 4703 E:\FR\FM\18JAN1.XXX pfrm03 PsN: 18JAN1
2616 Federal Register / Vol. 5, No. 11 / Tuesday, January 18, 2000 / Notices

dependant. It is extensively metabolized

with less than 2% of recovered 14C

radioactivity representing the parent

compound. Twenty–eight metabolites

were identified in the urine, and 28 in

the feces. Ten metabolites were

identified in both urine and feces.

Prometryn is excreted predominantly in

the urine and feces, with slightly higher

concentrations in the urine. The 7–day

recovery of 14C radioactivity averaged

95% for all dosing groups.

C. Aggregate Exposure

1. Dietary exposure—Acute exposure

and risk. Acute dietary risk assessments

are performed for a pesticide if a

toxicological study has indicated the

possibility of an effect of concern

occurring as a result of a 1–day or single

exposure. The margin of exposure

(MOE) value for females (13 years and

older) was 1,200,000. This value is

significantly higher than the Agency’s

level of concern.

2. Chronic exposure and risk.

Assuming 100% of the crop are treated

and residues are at tolerance levels, the

theoretical maximum residue

contribution (TMRC) from the

established and proposed tolerances is

0.000056 mg/kg/day and utilizes less

than 1% of the chronic population

adjusted dose (cPAD) for the U.S.

population. For exposure of the most

highly exposed subgroup in the

population, non-nursing infants, the

TMRC is 0.0016 mg/kg/day which

utilizes less than 1% of the cPAD.

i. Food. Tolerances have been

established 40 CFR 180.222(a) for the

residues of prometryn, 2,4-

bis(isopropylamino)-6-methylthio-striazine, in celery at 0.5 ppm; corn

forage, fresh corn, and corn grain at 0.25

ppm; cotton at 1 ppm; cottonseed at

0.25 ppm; and pigeon peas at 0.25 ppm.

Tolerances with regional registration

have been established 40 CFR

180.222(b) for the residues of prometryn

in dill at 0.3 ppm and parsley at 0.1

ppm.

ii. Drinking water. Despite the

potential for exposure through drinking

water, the percentage of the cPAD that

will be utilized by dietary exposure

(including drinking water exposure) to

residues of prometryn does not exceed

100% for any of the population

subgroups. Considering food only, the

population subgroup with the largest

percentage of the cPAD occupied is

0.0000056 mg/kg/day at < 1% of the

cPAD. Therefore taking into account the

completeness and reliability of the

toxicity data and the conservative

exposure assessment, there is a

reasonable certainty that no harm will

result to infants and children from

aggregate exposure to prometryn

residues.

2. Non-dietary exposure. Prometryn is

currently not registered for residential

use such as turf and ornamentals.

Therefore, there is no expectation of

non-occupational residential exposures.

D. Cumulative Effects

Cumulative exposure to substances

with a common mechanism of toxicity.

Prometryn is a member of the triazine

class of pesticides. Other members of

this class include atrazine, simazine,

cyanazine, prometon, propazine,

metribuzin, hexazinone, ametryn,

terbutryne, dipropetryn, and ethiozin.

Section 408(b)(2)(D)(v) requires that,

when considering whether to establish,

modify, or revoke a tolerance, the

Agency considers ‘‘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. IR-4 does not have, at this

time, available data to determine

whether prometryn has a common

mechanism of toxicity with other

substances or how to include this

pesticide in a cumulative risk

assessment. Since there are not

metabolites of toxicological concern

associated with prometryn, IR-4 has not

assumed that prometryn has a common

mechanism of toxicity with other

substances.

E. Safety Determination

1. U.S. population— Acute risk. The

acute aggregate dietary MOE was

estimated to be greater than 1,000,000

for females age 13 and older (accounts

for both maternal and fetal exposure),

the population subgroup of concern.

The MOE calculations were based on

the developmental NOAEL in rabbits of

12 mg/kg. This risk assessment assumed

100% of the crop was treated with

tolerance level residues on all treated

crops consumed, resulting in a

significant over estimate of dietary

exposure. The large acute dietary MOE

calculated for females age 13 and older

provides assurance that there is a

reasonable certainty of no harm for

infants and children to prometryn.

2. Chronic risk. Using the

conservative exposure assumptions

described above, the aggregate exposure

to prometryn from food will utilize less

than 1% of the cPAD for infants and

children. EPA generally has no concern

for exposures below 100% of the cPAD

because the cPAD represents the level at

or below which daily aggregate dietary

exposure over a lifetime will not pose

appreciable risks to human health.

There are no chronic exposure scenarios

for non-dietary uses of prometryn which

would contribute to the aggregate risk.

Taking into account, the completeness

and reliability of the toxicity data and

the conservative exposure assessment,

IR-4 concludes that there is a reasonable

certainty that no harm will result from

aggregate exposure to prometryn

residue’s.

3. Infants and children-safety factor—

i. In general. In assessing the potential

for additional sensitivity of infants and

children to residues of prometryn, data

were considered from the

developmental toxicity studies in the rat

and rabbit and a 2–generation

reproduction study in the rat. The

developmental toxicity studies are

designed to evaluate adverse effects on

the developing organism resulting from

pesticide exposure during prenatal

development to one or both parents.

Reproduction studies provide

information relating to effects from

exposure to the pesticide on the

reproductive capability of mating

animals and data on systemic toxicity.

FFDCA section 408 provides that EPA

shall apply an additional tenfold margin

of safety for infants and children in the

case of threshold effects to account for

prenatal and postnatal toxicity and the

completeness of the data base unless

EPA determines that a different margin

of safety will be safe for infants and

children. Margins of safety are

incorporated into EPA risk assessments

either directly through use of a 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 MOE and

uncertainty factor (usually 100 for

interspecies and intraspecies variability)

and not the additional tenfold MOE/

uncertainty factor when EPA has a

complete data base under existing

guidelines and when the severity of the

effect in infants or children or the

potency or unusual toxic properties of a

compound do not raise concerns

regarding the adequacy of the standard

MOE/safety factor.

ii. Developmental and reproductive

toxicity studies. The prenatal and

postnatal toxicology data base for

prometryn is complete with respect to

current toxicological data requirements.

The results of these studies indicate that

infants and children are not more

sensitive to exposure, based on the

Federal Register / Vol. 5, No. 11 / Tuesday, January 18, 2000 / Notices 2617

results of the oral rat and rabbit

developmental toxicity studies and the

2-generation reproductive toxicity study

in rats. The developmental studies in

rats and rabbits demonstrate that no

prenatal extra sensitivity is present.

However, based on the developmental

effects observed in rabbits, an acute

dietary risk assessment was performed

for women age 13 and older. The MOE

was estimated greater than 1,000,000.

Therefore, IR-4 concludes that reliable

data support use of the standard 100-

fold MOE/uncertainty factor and that an

additional tenfold safety factor is not

needed to protect infants and children.

F. International Tolerances

There are no Codex or Mexican limits

for prometryn on cilantro. This proposal

will harmonize tolerances with 0.1 ppm

Canadian maximum limit for residues in

cilantro.

[FR Doc. 00–1064 Filed 1–14–00; 8:45 am]

BILLING CODE 6560–50–F

EQUAL EMPLOYMENT OPPORTUNITY

COMMISSION

Agency Information Collection

Activities: Submission for OMB

Review; Final Comment Request

AGENCY: Equal Employment

Opportunity Commission.

ACTION: Final Notice of Submission for

OMB Review; Final Comment Request

SUMMARY: In accordance with the

Paperwork Reduction Act, the Equal

Employment Opportunity Commission

(EEOC) has submitted a request for

clearance of the information collection

described below to the Office of

Management and Budget (OMB). A

notice that the EEOC would be

submitting this request was published

in the Federal Register on October 14,

1999, allowing for a 60-day public

comment period. No public comments

were received.

DATES: Written comments on this final

notice must be submitted on or before

February 17, 2000.

ADDRESSES: Comments on this final

notice should be submitted to the Office

of Information and Regulatory Affairs,

Attention: Stuart Shapiro, Desk Officer

for the U.S. Equal Employment

Opportunity Commission, Office of

Management and Budget, 725 17th

Street, NW, Room 10235, New

Executive Office Building, Washington,

DC 20503 or electronically mailed to

SSHAPIRO@OMB.EOP.GOV. Requests

for copies of the proposed information

collection request should be addressed

to Mr. Neckere at the address below.

FOR FURTHER INFORMATION CONTACT:

Joachim Neckere, Director, Program

Research and Surveys Division, 1801 L

Street, NW, Room 9222, Washington,

DC 20507, (202) 663–4958 (voice) or

(202) 663–7063 TDD).

SUPPLEMENTARY INFORMATION: Collection

Title: Local Union Report (EEO–3).

OMB–Number: 3046–0006.

Frequency of Report: Biennial.

Type of Respondent: Referral local

unions with 100 or more members.

Description of Affected Public:

Referral local unions and independent

or unaffiliated referral unions and

similar labor organizations.

Number of Responses: 3,000.

Reporting Hours: 3,000 (4,500 hours

including recordkeeping).

Number of Forms: 1.

Federal Cost: $43,500.

Abstract: Section 709(c) of Title VII of

the Civil Rights Act of 1964, as

amended, 42 U.S.C. 2000e–8(c), requires

employers to make and keep records

relevant to a determination of whether

unlawful employment practices have

been or are being committed and to

make reports therefrom as required by

the EEOC. Accordingly, the EEOC has

issued regulations which set forth the

reporting requirements for various kinds

of labor organizations. Referral local

unions with 100 or more members have

been required to submit EEO–3 reports

since 1967 (biennially beginning in

1986).

EEO–3 data are used by the EEOC to

investigate charges of discrimination

against referral local unions. In

addition, the data are used to support

EEOC decisions and conciliations, and

for research. Pursuant to section 709(d)

of Title VII of the Civil Rights Act of

1964, as amended, EEO–3 data are also

shared with 86 State and local Fair

Employment Practices Agencies

(FEPAs).

Burden Statement: The respondent

burden for this information collection is

minimal. The estimated number of

respondents included in the biennial

EEO–3 survey is 3,000 referral unions.

Total biennial reporting is estimated to

be 3,000 hours, and total biennial

reporting and recordkeeping is 4,500

hours. Because referral local unions

often have small management staffs, the

use of filing the EEO–3 report by

diskette or magnetic tape, although

encouraged, has been less successful.

Dated: January 10, 2000.

Ida L. Castro,

Chairwoman.

[FR Doc. 00–1006 Filed 1–14–00; 8:45 am]

BILLING CODE 6150–01–M

FEDERAL HOUSING FINANCE BOARD

Sunshine Act Meeting

Announcing an Open Meeting of the

Board

TIME AND DATE: 10:00 A.M., Wednesday,

January 19, 2000.

PLACE: Board Room, Second Floor,

Federal Housing Finance Board, 1777 F

Street, N.W., Washington, D.C. 20006.

STATUS: The entire meeting will be open

to the public.

MATTERS TO BE CONSIDERED DURING

PORTIONS OPEN TO THE PUBLIC:

• Final Rule: Reorganization of

Finance Board Regulations

Proposed Rule: Calculation of

REFCorp Obligation

• Interim Final Rule: Amendments to

Election Regulation

CONTACT PERSON FOR MORE INFORMATION:

Elaine L. Baker, Secretary to the Board,

(202) 408–2837.

William W. Ginsberg,

Managing Director.

[FR Doc. 00–1167 Filed 1–13–00; 11:45 am]

BILLING CODE 6725–01–P

FEDERAL MARITIME COMMISSION

[Docket No. 00–01]

Kawasaki Kisen Kaisha, Ltd. v.

Intercontinental Exchange, Inc.; Notice

of Filing of Complaint and Assignment

Notice is given that a complaint was

filed by Kawasaki Kisen Kaisha, Ltd.

(‘‘Complainant’’), against

Intercontinental Exchange, Inc.

(‘‘Respondent’’). The complaint was

served on January 7, 2000. Complainant

alleges that Respondent, an ocean

transportation intermediary, violated

section 10(a)(1) of the Shipping Act of

1984, 46 U.S.C. app. section 1709(a)(1),

by incurring unpaid freight charges

pursuant a service contract in the

amount of $265,126.23, making false

representations, uttering checks without

funds, and presenting false Wire

Transfer Requests.

This proceeding has been assigned to

the office of Administrative Law Judges.

Hearing in this matter, if any is held,

shall commence within the time

limitations prescribed in 46 CFR 502.61,

and only after consideration has been

given by the parties and the presiding

officer to the use of alternative forms of

dispute resolution. The hearing shall

include oral testimony and crossexamination in the discretion of the

presiding officer only upon proper

showing that there are genuine issues of

material fact that cannot be resolved on