18116 Federal Register / Vol. 62, No. 71 / Monday, April 14, 1997 / Notices

their business clients. They too are

developing industry-specific

compliance guides; however, an

essential first step in developing

industry-specific guides is knowing

what has already been developed and

what is underway. By serving as a focal

point for the distribution and

notification of sector-specific activities

throughout the nation, the compliance

assistance centers can potentially

prevent the duplication of efforts of

state and local assistance programs.

II. What Do the Centers Provide

Compliance Assistance Centers

function as communication centers

rather than physical ‘‘walk-ins.’’ Each

center provides some or all of the

following services via the Internet and

toll-free telephone numbers:

• Easy access to industry-specific,

multi-media federal regulations,

interpretations, and compliance guides;

also, certain state and local information;

• Compliance tools that can be used

by small business, regulators,

inspectors, and technical assistance

providers to audit, determine emissions

and wastes, and calculate the costs of

compliance;

• Process-specific training for

regulators and technical assistance

providers who seek more in-depth

knowledge of the businesses they

regulate;

• A place to ask questions and get

answers, through specialized

conferences and forums, and access to

experts who can answer compliance and

technical questions;

• Databases of technologies and

techniques that can help small

businesses come into compliance, with

an emphasis on pollution prevention

methods that save money.

III. How To Reach the Centers

Following are the Internet addresses

and contact names and telephone

numbers for the four existing centers:

a. National Metal Finishing Resource

Center

NMFRC provides technical assistance

and information on environmental

compliance and pollution prevention to

the metal finishing industry.

Internet: http://www.nmfrc.org

Contacts: National Center for

Manufacturing Science, Paul Chalmer,

313–995–4911; U.S. EPA, Scott Throwe,

202–564–7013.

b. Printer’s National Compliance

Assistance Center

PNEAC provides compliance

assistance and pollution prevention

information to the printing industry.

Internet: http://

www.hazard.uiuc.edu/pneac/

pneac.html

Contacts: Illinois Hazardous Waste

Research and Information Center, Gary

Miller, 217–333–8942; U.S. EPA, Doug

Jamieson, 202–564–7041.

c. GreenLinkTM—the Automotive

Compliance Information Assistance

Center.

GreenLinkTM provides compliance

assistance to the automotive service

industry. To obtain voice, facsimile, or

mailed information, call the center’s

toll-free number, 1–888–GRN–LINK.

Internet: http://www.ccargreenlink.org

Contacts: U.S. EPA, Everett Bishop,

202–564–7032; Coordinating Committee

for Automotive Repair, Sherman Titens,

816–561–8388.

d. National Agriculture Compliance

Assistance Center

This Center provides information to

help producers of agricultural

commodities and their supporting

businesses meet their environmental

requirements; prevent pollution before

it occurs; and reduce costs by

identifying flexible, common-sense

ways to achieve compliance.

Internet: http://es.inel.gov/oeca/ag/

aghmpg.html

Contacts: U.S. EPA, Ginah Mortensen,

913–551–7207 (fax: 913–551–7270).

IV. How to Get Involved With Future

Centers

EPA has developed partnerships for

the Transportation Compliance

Assistance Center and the Printed

Wiring Board Manufacturing Center. For

more information, contact Virginia

Lathrop (transportation) at 202–564–

7057 and Keith Brown (PWB

manufacturing) at 202–564–7124. EPA

is currently developing the Chemical

Manufacturing and Local Government

Centers. If you are interested in learning

more about the Chemical Manufacturing

Center please contact Emily Chow at

202–564–7071. For more information on

the Local Government Environmental

Network, which will provide a central

location for state and local access to

federally-developed compliance

assistance information related to local

governments, contact Wendy Miller at

202–564–7102 or John Dombrowski at

202–564–7036.

Dated: April 4, 1997.

Elaine Stanley,

Director, Office of Compliance.

[FR Doc. 97–9579 Filed 4–11–97; 8:45 am]

BILLING CODE 6560–50–P

ENVIRONMENTAL PROTECTION

AGENCY

[PF–730; FRL–5599–7]

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

agricultural commodities.

DATES: Comments, identified by the

docket control number PF–730, must be

received on or before May 14, 1997.

ADDRESSES: By mail submit written

comments to: Public Response and

Program Resources Branch, Field

Operations Divison (7505C), 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 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. 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: By

mail: Joanne Miller, PM-23, Registration

Division (7505C), Office of Pesticide

Programs, Environmental Protection

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

DC 20460. Office location and telephone

number: Rm. 237, Crystal Mall #2, 1921

Jefferson Davis Highway, Arlington, VA

22202, (703) 305-6224; e-mail:

miller.joanne@epamail.epa.gov.

SUPPLEMENTARY INFORMATION: EPA has

received pesticide petitions as follows

proposing the establishment and/or

amendment of regulations for residues
Federal Register / Vol. 62, No. 71 / Monday, April 14, 1997 / Notices 18117

of certain pesticide chemicals in or on

various raw agricultural 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 grantinig of

the petition. Additional data may be

needed before EPA rules on the petition.

The official record for this notice, as

well as the public version, has been

established for this notice of filing

under docket control number PF–730

(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 file format or ASCII file

format. All comments and data in

electronic form must be identified by

the docket control number (PF–730) and

appropriate petition number. Electronic

comments on this notice may be filed

online at many Federal Depository

Libraries.

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

List of Subjects

Environmental protection,

Agricultural commodities, Food

additives, Feed additives, Pesticides and

pests, Reporting and recordkeeping

requirements.

Dated: April 2, 1997.

Stephen L. Johnson,

Director, Registration Division, Office of

Pesticide Programs.

Summaries of Petitions

Below summaries of the pesticide

petitions are printed. The summaries of

the petitions were prepared by the

petitioners. 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. K-I Chemical, U.S.A. Inc.

PP 7F4821

EPA has received a pesticide petition

(PP 7F4821) from K-I Chemical, U.S.A.

Inc., 11 Martine Avenue, 9th Floor,

White Plains, New York 10606,

proposing pursuant to section 408(d) of

the Federal Food, Drug and Cosmetic

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

40 CFR part 180 by establishing a

tolerance for residues of the herbicide

fluthiacet-methyl: Acetic acid, [[2-

chloro-4-fluoro-5-[(tetrahydro-3-oxo1H,3H-[1,3,4]thiadiazolo[3,4-a]

pyridazin-1-

ylidene)amino]phenyl]thio]-methyl

ester in or on the raw agricultural

commodites field corn grain and sweet

corn grain (K + CWHR) at 0.02 ppm and

corn forage and fodder at 0.05 ppm. The

proposed analytical method is gas

chromatography using a nitrogen

phosphorus detector and a large-bore

fused silica column.

A. Fluthiacet-methyl uses:

Fluthiacet-methyl, Acetic acid, [[2-

chloro-4-fluoro-5-[(tetrahydro-3-oxo1H,3H-[1,3,4]thiadiazolo[3,4-

a]pyridazin-1-

ylidene)amino]phenyl]thio]-methyl

ester, is a new herbicide active

ingredient in the imide chemistry class.

A petition for tolerance for fluthiacetmethyl in soybeans (Pesticide Petition

Number 6F04614) submitted by

Novartis Crop Protection, Inc. is

pending EPA review. K-I, Chemical,

U.S.A. has submitted a petition for

tolerance in corn. Fluthiacet-methyl will

be formulated as a 4.75% wettable

powder, packaged in water-soluble bags,

and sold under the trade name Action

herbicide. Action is a highly selective

herbicide for use in soybeans and corn

postemergence, and is particularly

effective in controlling velvetleaf.

Control of other broadleaf weeds in corn

and soybeans is enhanced and the

spectrum of control is broadened when

Action is tank mixed with other

postemergence herbicides registered for

use in these crops.

Action offers effective weed control at

extremely low use rates. The maximum

use rate per season is 0.0089 lb. active

ingredient (3 oz. of formulated product)

per acre consisting of a maximum of two

applications. There is a wide

application window extending in corn

from the 2-leaf stage (leaves fully

expanded with collars exposed) to 48

inches tall or prior to tasseling,

whichever comes first, and the amount

of Action to apply depends on the weed

species and weed height. Tank mixing

Action with other postemergence

herbicides further reduces the amount

required to control target weeds.

The purpose of this petition is to

establish a tolerance for fluthiacetmethyl in field and sweet corn. The

tolerance proposed in section

408(d)(2)(A)(vii) is:

Comodity Part per million

(ppm)

corn, sweet - grain (k +

CWHR)

0.02 ppm

corn, field - grain 0.02 ppm

corn - forage and fodder 0.05 ppm

B. Fluthiacet-methyl Safety

In support of the pending petition for

tolerance in soybeans, and hereby

referenced by K-I Chemical, Novartis

Crop Protection (Ciba) submitted a full

battery of toxicology studies including,

acute effects, chronic feeding,

oncogenicity, teratogenicity,

mutagenicity, and reproductive toxicity

tests. The studies indicate that

fluthiacet-methyl has a low order of

acute toxicity with acute effects in

catgegory III and IV, is not neurotoxic,

does not pose a genotoxicity hazard, and

is not a reproductive toxicant or a

teratogen.

Potential exposure to fluthiacetmethyl via the diet or drinking water

and through handling is very limited.

Because of rapid environmental

degradation, extremely low residues in

food crops, and water-soluble

packaging, considerable margins of

safety exist for dietary exposure for all

subgroups of the population and for

worker exposure as well.

The following mammalian toxicity

studies have been conducted to support

the proposed tolerance for fluthiacetmethyl:

A rat acute oral study with an LD50 >

5,000 mg/kg.

A rabbit acute dermal study with an

LD50 > 2,000 mg/kg.

A rat inhalation study with an LC50 >

5.05 mg/liter.

A primary eye irritation study in the

rabbit showing moderate eye irritation.

A primary dermal irritation study in

the rabbit showing no skin irritation.

A primary dermal sensitization study

in the Guinea pig showing no

sensitization.

28–day dermal toxicity study in rats

with a NOEL equal to or higher than the

limit dose of 1,000 mg/kg.

6–Week dietary toxicity study in dogs

with a NOEL of 162 mg/kg/day in males
18118 Federal Register / Vol. 62, No. 71 / Monday, April 14, 1997 / Notices

and 50 mg/kg/day in females based on

decreased body weight gain and modest

hematological changes.

90–day subchronic dietary toxicity

study in rats with a NOEL of 6.2 mg/kg/

day based on liver changes and

hematological effects.

24–month combined chronic toxicity/

carcinogenicity study in rats with a

NOEL of 2.1 mg/kg/day. Based on

reduced body weight development and

changes in bone marrow, liver, pancreas

and uterus the MTD was exceeded at

130 mg/kg/day.

A positive trend of adenomas of the

pancreas in male rats treated at 130 mg/

kg/day and above may be attributable to

the increased survival of the rats treated

at high doses.

18–month oncogenicity study in mice

with a NOEL of 0.14 mg/kg/day. Based

on liver changes, the MTD was reached

at 1.2 mg/kg/day. The incidence of

hepatocellular tumors was increased in

males treated at 12 and 37 mg/kg/day.

Teratology study in rats with a

maternal and developmental NOEL

equal to or greater than 1,000 mg/kg/

day.

Teratology study in rabbits with a

maternal NOEL greater than or equal to

1,000 mg/kg/day and a fetal NOEL of

300 mg/kg based on a slight delay in

fetal maturation.

2–generation reproduction study in

rats with a NOEL of 36 mg/kg/day,

based on liver lesions in parental

animals and slightly reduced body

weight development in parental animals

and pups. The treatment had no effect

on reproduction or fertility.

Acute neurotoxicity study in rats.

Neurotoxic effects were not observed.

The NOEL was 2,000 mg/kg.

90–day subchronic neurotoxicity

study in rats. The NOEL was 0.5 mg/kg/

day based on reduced body weight gain.

No clinical or morphological signs of

neurotoxicity were detected at any dose

level.

In vitro gene mutation tests: Ames test

- negative; Chinese hamster V79 test -

negative; rat hepatocyte DNA repair test

- negative; E. Coli letal DNA damage test

- negative.

In vitro chromosomal aberration tests:

Chinese hamster ovary - positive at

cytotoxic doses; Chinese hamster lung -

positive at cytotoxic doses; human

lymphocyes - positive at cytotoxic

doses.

In vivo chromosome aberration tests:

Micronucleus assays in rat liver -

negative; mouse bone marrow test -

negative.

1. Threshold effects. Using the

Guidelines for Carcinogenic Risk

Assessment published September 24,

1986 (51 FR 33992), K-I Chemical

believes the Agency will classify

fluthiacet-methyl as a Group ‘‘C’’

carcinogen (possible human carcinogen)

based on findings of benign and

malignant liver tumors in male mice.

These tumors most likely resulted from

a chronic regenerative and proliferative

response of the affected epithelial cells.

This response is a non-genotoxic,

threshold effect which is due to the

accumulation of cytotoxic porphyrins. A

positive trend of proliferative pancreatic

changes in male rats is likely

attributable to the increased survival of

the rats in the high dose groups. The

lesions observed are not uncommon in

the rat strain used.

Because the effects observed are

threshold effects, K-I Chemical believes

that exposure to fluthiacet-methyl

should be regulated using a margin of

exposure approach. The RfD for

fluthiacet-methyl can be defined at

0.0014 milligrams (mg)/kilogram(kg)/

day based on an 18-month feeding study

in mice with a No-Observed Effect Level

(NOEL) of 0.14 mg/kg/day and an

uncertainty factor of 100.

2. Non-threshold effects. Based on the

results of an extensive program of

genotoxicity studies, fluthiacet-methyl

is not mutagenic in vivo. As outlined

above, effects observed in toxicology

studies are attributable to an epigenetic,

cytotoxic mechanism, resulting in

degenerative and inflammatory changes

in the target organs. It is therefore

justified that exposure to fluthiacetmethyl should be regulated using a

margin of exposure approach.

3. Aggregate exposure. In this

assessment, K-I Chemical has

conservatively assumed that 100% of all

soybeans and corn used for human

consumption would contain residues of

fluthiacet-methyl and all residues

would be at the level of the proposed

tolerances. The potential dietary

exposure to fluthiacet-methyl was

calculated on the basis of the proposed

tolerance which is based on an LOQ of

0.01 ppm in soybeans and 0.02 ppm in

corn (2x LOQ). The anticipated residues

in milk, meat and eggs resulting from

feeding the maximum allowable amount

of soybean and corn commodities to

cattle and poultry were calculated, and

the resulting quantities were well below

the analytical method LOQ. Therefore,

tolerances for milk, meat and eggs are

not required. Assuming 100% crop

treated values, the chronic dietary

exposure of the general U.S. population

to fluthiacet-methyl would correspond

to 2.3% of the RfD.

Other potential sources of exposure of

the general population to residues of

pesticides are residues in drinking

water. Although fluthiacet-methyl has a

slight to medium leaching potential; the

risk of the parent compound to leach to

deeper soil layers is negligible under

practical conditions in view of the fast

degradation of the product. For

example, the soil metabolism half-life

was extremely short, ranging from 1.1

days under aerobic conditions to 1.6

days under anaerobic conditions. Even

in the event of very heavy rainfalls

immediately after application, which

could lead to a certain downward

movement of the parent compound,

parent fluthiacet-methyl continues to be

degraded during the transport into

deeper soil zones.

Considering the low application rate

of fluthiacet-methyl, the strong soil

binding characteristics of fluthiacetmethyl and its degradates, and the rapid

degradation of fluthiacet-methyl in the

soil, there is no risk of ground water

contamination with fluthiacet-methyl or

its metabolites. Thus, aggregate riskof

exposure to fluthiacet-methyl does not

include drinking water.

Fluthiacet-methyl is not registered for

any other use and is only proposed for

use on agricultural crops. Thus, there is

no potential for non-occupational

exposure other than consumption of

treated commodities containing

fluthiacet-methyl residue.

K-I Chemical also considered the

potential for cumulative effects of

fluthiacet-methyl and other substances.

However, a cumulative exposure

assessment is not appropriate at this

time because there is no information

available to indicate that effects of

fluthiacet-methyl in mammals would be

cumulative with those of another

chemical compound. Thus K-I Chemical

is considering only the potential risk of

fluthiacet-methyl in its aggregate

exposure assessment.

4. Safety to the U.S. population.

Using the very conservative exposure

assumptions described above coupled

with toxicity data for fluthiacet-methyl,

K-I Chemical calculated that aggregate,

chronic exposure to fluthiacet-methyl

will utilize no more than 2.3% of the

RfD for the U.S. population. Because the

actual anticipated residues are well

below tolerance levels and the percent

crop treated with fluthiacet-methyl is

expected to be less than 25% of planted

corn or soybeans, a more realistic

estimate is that dietary exposure will

likely be at least 20 times less than the

conservative estimate previously noted

(the margins of exposure will be

accordingly higher). Exposures below

100 percent of the RfD are generally not

of concern because the RfD represents

the level at or below which daily

aggregate dietary exposure over a
Federal Register / Vol. 62, No. 71 / Monday, April 14, 1997 / Notices 18119

lifetime will not pose appreciable risks

to human health.

Also the acute dietary risk to

consumers will be far below any

significant level; the lowest NOEL from

a short term exposure scenario comes

from the teratology study in rabbits with

a NOEL of 300 mg/kg. This NOEL is

2,000-fold higher than the chronic

NOEL which provides the basis for the

RfD (see above). Acute dietary exposure

estimates which are based on a

combined food survey from 1989 to

1992 predict margins of exposure of at

least one million for 99.9% of the

general population and for women of

child bearing age. Margins of exposure

of 100 or more are generally considered

satisfactory.

Therefore, K-I Chemical concludes

that there is a reasonable certainty that

no harm will result from aggregate

exposure to fluthiacet-methyl residues.

5. Safety to infants and children. In

assessing the potential for additional

sensitivity of infants and children to

residues of fluthiacet-methyl, K-I

Chemical considered data from

developmental toxicity studies in the rat

and rabbit and a 2-generation

reproduction study in the rat. A slight

delay in fetal maturation was observed

in a teratology study in rabbits at a daily

dose of 1,000 mg/kg. In a 2-generation

reproduction study fluthiacet-methyl

did not affect the reproductive

performance of the parental animals or

the physiological development of the

pups. The NOEL was 500 ppm for

maternal animals and their offspring,

which is 50,000 fold higher than the

RfD.

Reference dose. Using the same

conservative exposure assumptions as

was used for the general population, the

percent of the RfD that will be utilized

by aggregate exposure to residues of

fluthiacet-methyl is as follows: 1.5% for

nursing infants less than 1 year old,

5.9% for non-nursing infants, and 5.2%

for children 1-6 years old. K-I Chemical

concludes that there is a reasonable

certainty that no harm will result to

infants and children from aggregate

exposure to residues of fluthiacetmethyl.

6. Estrogenic effects. Based on the

results of short-term, chronic, and

reproductive toxicity studies there is no

indication that fluthiacet-methyl might

interfere with the endocrine system.

Considering further the low

environmental concentrations and the

lack of bioaccumulation, there is no risk

of endocrine disruption in humans or

wildlife.

7. Chemical residue. There are no

Codex maximum residue levels

established for residues of fluthiacetmethyl on corn. The nature of the

residues in corn and animals (goat and

hen) is adequately understood following

application of fluthiacet-methyl.

Residues do not concentrate in

processed commodities. K-I Chemical

has submitted practical analytical

methods (AG-603B and AG-624) for

detecting and measuring the level of

fluthiacet-methyl in or on corn and corn

commodities and in animal tissues with

a limit of detection that allows

monitoring residues at or above the

levels set for the proposed tolerance.

The limit of quantitation of the crop

method is 0.01 ppm in corn and corn

commodities, 0.05 ppm in animal

tissues and 0.01 ppm in milk. The crop

method involves extraction, filtration,

and solid phase clean up. Residue levels

of fluthiacet-methyl are determined by

gas chromatographic analysis utilizing a

nitrogen phosphorus detector and a

fused-silica column. The animal tissue

method involves extraction, filtration,

and partition. Determination of residue

levels in animal tissues is by HPLC with

UV detection via column switching

using C1 and C18 columns. The analyte

of interest in animal tissues and milk is

the major animal metabolite CGA300403. EPA can provide information

on these methods to FDA. The methods

will be available to anyone who is

interested in pesticide residue

enforcement from the Field Operations

Division, EPA Office of Pesticide

Programs.

The residue of concern in corn is

fluthiacet-methyl per se. Twenty one

field residue studies were conducted

with corn grown in nineteen states.

Fifteen of the studies were on field corn

and six on sweet corn. Residues of

fluthiacet-methyl in treated corn grain

and ears were less than the method LOQ

(<0.01 ppm). Residues in forage after the

day of application were less than the

proposed tolerance of 0.05 ppm. The

proposed tolerances of 0.02 ppm in

grain and 0.05 ppm in forage and fodder

are adequate to cover residues likely to

occur when Action herbicide is applied

to corn as directed.

A feeding study in cattle has been

submitted and tolerances for residues of

fluthiacet-methyl in meat and milk will

not be requested. The results from hen

and goat metabolism studies, wherein

fluthiacet-methyl was fed at exaggerated

rates, showed that the transfer of

fluthiacet-methyl residues from feed to

tissues, milk and eggs is extremely low.

No detectable residues of fluthiacetmethyl (or metabolite CGA-300403)

would be expected in meat, milk,

poultry, or eggs after feeding the

maximum allowable amount of treated

corn and soybeans. This conclusion is

based on residue data from the corn and

soybean metabolism and field residue

chemistry studies coupled with the

residue transfer from feed to tissues,

milk and eggs obtained in the goat and

hen metabolism studies.

In studies with processed corn

fractions, no concentration of fluthiacetmethyl was observed and tolerances in

processed commodities will not be

required. In addition, confined

rotational crop studies indicated that

fluthiacet-methyl will not be taken up

by rotational crops.

Analytical Method AG-603B has been

submitted for analysis of residues of

fluthiacet-methyl in soybeans and in

corn and its processed fractions. This

method can be provided to the FDA.

Residue levels of fluthiacet-methyl are

determined by gas chromatography and

the limit of detection for the method is

0.01 ppm.

8. Environmental fate. Action

degraded rapidly under laboratory and

field conditions. Laboratory hydrolysis

under basic conditions was T1/2 5

hours at pH 9 and stable under acidic

conditions (T1/2 485 days at pH 5). The

soil metabolism half-life was extremely

short, ranging from 1.1 days under

aerobic conditions to 1.6 days under

anaerobic conditions. Photodegradation

was rapid in soil (T1/2 0.5 days) and

moderate in solution at pH 5 (5 days).

Because of the extremely low use rate

and very short half-life in the field, field

dissipation experiments were conducted

with radiolabeled chemical. After bareground application, the half-life of

Action was 1 day in sandy loam and 1.8

days in clay loam. All degradates

identified in the field were also

identified in the laboratory studies.

Parent and aged leaching laboratory

experiments showed that the mobility of

Action ranged from slight to medium by

soil type. Based on estimates of relative

mobility (Koc), Action was classified as

having medium mobility in sand and

low mobility in loam, silt loam and clay.

The major degradation products of

Action were found to have high to low

mobility classifications based on Koc

estimations. Although the data suggest

that some of the degradates are highly

mobile a high degree of soil binding is

expected based on results of the

laboratory and the field experiments.

Since weeds and crop will intercept the

majority of this product when it is

applied, and given the extremely low

use rate and high degree of soil binding,

Action herbicide is not expected to

leach into groundwater.
18120 Federal Register / Vol. 62, No. 71 / Monday, April 14, 1997 / Notices

2. Novartis Crop Protection

PP 6F4751

EPA has received a pesticide petition

(PP 6F4751) from Novartis Crop

Protection, Inc., P. O. Box 18300,

Greensboro, North Carolina 27419,

proposing pursuant to section 408(d) of

the Federal Food, Drug and Cosmetic

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

180.368 by establishing a tolerance for

residues of the herbicide metolachlor in

or on the raw agricultural commodity

tomatoes at 0.1 ppm. The proposed

analytical method is available for

enforcement purposes. Pursuant to

section 408(d)(2)(A)(i) of the FFDCA, as

amended, Novartis Crop Protection has

submitted the following summary of

information, data and arguments in

support of their pesticide petition. This

summary was prepared by Novartis

Crop Protection and EPA has not fully

evaluated the merits of the petition. EPA

edited the summary to clarify that the

conclusions and arguments were the

petitioners and not necessarily EPA’s

and to remove certain extraneous

material.

A. Metolachlor Uses

Metolachlor is a chloroacetanilide

herbicide registered primarily for grass

control on a wide variety of crops. It is

proposed for use on tomatoes at a

maximum rate of 3 lbs. active ingredient

per acre depending on soil texture and

organic matter content. One application

may be made preplant incorporated,

preplant before transplanting, postdirected or post-over-the-top. A 90–day

preharvest interval is to be observed.

B. Metabolism and Analytical Method

1. Metabolism. The qualitative nature

of the metabolism of metolachlor in

plants and animals is well understood.

Metabolism in plants involves

conjugation of the chloroacetyl side

chain with glutathione, with subsequent

conversion to the cysteine and thiolactic

acid conjugates. Oxidation to the

corresponding sulfoxide derivatives

occurs and cleavage of the side chain

ether group, followed by conjugation

with glucose. In animals, metolachlor is

rapidly metabolized and almost totally

eliminated in the excreta of rats, goats,

and poultry. Metabolism in plants and

animals proceeds through common

Phase 1 intermediates and glutathione

conjugation.

2. Analytical methodology. Novartis

Crop Protection has submitted a

practical analytical method involving

extraction by acid reflux, filtration,

partition and cleanup with analysis by

gas chromatography using Nitrogen/

Phosphorous (N/P) detection. The

methodology converts residues of

metolachlor into a mixture of CGA37913 and CGA-49751. The limit of

quantitation (LOQ) for the method is

0.03 ppm for CGA-37913 and 0.05 ppm

for CGA-49751.

C. Magnitude of Residue

Thirteen field trials were conducted

in major tomato production areas across

the United States. Both tomato and its

processed fractions were analyzed for

residues of metolachlor, measured as

CGA-37913 and CGA-49751. One

application of metolachlor at 3.0 lbs. ai/

A (1X) was made post-foliar to tomato

transplants. Exaggerated rate

applications (2X, 3X and 5X) were also

made. Two of the 13 trials were used for

processing into tomato commodity

products. No residues (LOQ of 0.08

ppm) were found at the 1X rate in the

RAC tomatoes. In processed

commodities at the 1X rate of 3.0 lbs ai/

A, residues of metolachlor were found

below the method LOQ in tomato puree

(0.4 ppm) and above the method LOQ in

dry pomace and tomato paste (0.16 and

0.13 ppm, respectively). Because

residues in tomato puree and paste

(commodities listed in Table 1 of

OPPTS 860.1000 as processed

commodities of tomatoes) are less than

2X the LOQ of 0.08 ppm, tolerances are

not required according to OPPTS

860.1520 (f)(3). No transfer of residues

to beef and dairy cattle or poultry is

expected from the use of metolachlor on

tomatoes.

D. Codex Alimentarius Commission

(CODEX)

There are no maximum residue levels

(MRL’s) established for residues of

metolachlor in or on raw agricultural

commodities.

E. Toxicological Profile of Metolachlor

1. Acute toxicity. Metolachlor has a

low order of acute toxicity. The

combined rat oral LD50 is 2,877 mg/kg.

The acute rabbit dermal LD50 is > 2,000

mg/kg and the rat inhalation LD50 is >

4.33 mg/L. Metolachlor is not irritating

to the skin and eye. It has been shown

to be positive in guinea pigs for skin

sensitization. End use formulations of

metolachlor also have a low order of

acute toxicity and cause slight skin and

eye irritation.

2. Subchronic toxicity. Metolachlor

was evaluated in a 21–day dermal

toxicity study in the rabbit and a 6–

month dietary study in dogs; NOELs of

100 mg/kg/day and 7.5 mg/kg/day were

established in the rabbit and dog,

respectively. The liver was identified as

the main target organ.

3. Chronic toxicity. A 1–year dog

study was conducted at dose levels of 0,

3.3, 9.7, or 32.7 mg/kg/day. The Agencydetermined RfD for metolachlor is based

on the 1 year dog study with a NOEL of

9.7 mg/kg/day. The RfD for metolachlor

is established at 0.1 mg/kg/day using a

100-fold uncertainty factor. A combined

chronic toxicity/oncogenicity study was

also conducted in rats at dose levels of

0. 1.5, 15 or 150 mg/kg/day. The NOEL

for systemic toxicity was 15 mg/kg/day.

4. Developmental/Reproduction. The

developmental and teratogenic potential

of metolachlor was investigated in rats

and rabbits. The results indicate that

metolachlor is not embyrotoxic or

teratogenic in either species at

maternally toxic doses. The NOEL for

developmental toxicity for metolachlor

was 360 mg/kg/day for both the rat and

rabbit while the NOEL for maternal

toxicity was established at 120 mg/kg/

day in the rabbit and 360 mg/kg/day in

the rat. A 2–generation reproduction

study was conducted with metolachlor

in rats at feeding levels of 0, 30, 300 and

1,000 ppm. The reproductive NOEL of

300 ppm (equivalent to 23.5 to 26 mg/

kg/day) was based upon reduced pup

weights in the F1a and F2a litters at the

1,000 ppm dose level(equivalent to 75.8

to 85.7 mg/kg/day). The NOEL for

parental toxicity was equal to or greater

than the 1,000 ppm dose level.

5. Carcinogenicity. An evaluation of

the carcinogenic potential of

metolachlor was made from two sets of

oncogenicity studies conducted with

metolachlor in rats and mice. Using the

Guidelines for Carcinogenic Risk

Assessment published September 24,

1986 (51 FR 33992) and the results of

the November, 1994 Carcinogenic Peer

Review, EPA has classified metolachlor

as a Group C carcinogen and

recommended using a Margin of

Exposure (MOE) approach to quantify

risk. This classification is based upon

the marginal tumor response observed

in livers of female rats treated with a

high (cytotoxic) dose of metolachlor

(3,000 ppm). The two studies conducted

in mice were negative for oncogenicity.

6. Genotoxicity. Assays for

genotoxicity were comprised of tests

evaluating metolachlor’s potential to

induce point mutations (Salmonella

assay and an L5178/TK+/- mouse

lymphoma assay), chromosome

aberrations (mouse micronucleus and a

dominant lethal assay) and the ability to

induce either unscheduled or scheduled

DNA synthesis in rat hepatocytes or

DNA damage or repair in human

fibroblasts. The results indicate that

metolachlor is not mutagenic or

clastogenic and does not provoke

unscheduled DNA synthesis.
Federal Register / Vol. 62, No. 71 / Monday, April 14, 1997 / Notices 18121

F. Threshold Effects

1. Chronic effects. Based on the

available chronic toxicity data, EPA has

established the RfD for metolachlor at

0.1 mg/kg/day. The RfD for metolachlor

is based on a 1–year feeding study in

dogs with a No-Observed Effect Level

(NOEL) of 9.7 mg/kg/day and an

uncertainty factor of 100.

2. Acute toxicity. Based on the

available acute toxicity data, it is

believed metolachlor does not pose any

acute dietary risks.

G. Non-threshold Effects

Carcinogenicity. Using its Guidelines

for Carcinogenic Risk Assessment

published September 24, 1986 (51 FR

33992), EPA has classified metolachlor

as Group ‘C’ for carcinogenicity

(possible human carcinogen) based on

findings of a carcinogenic effect in the

liver of the female rat. Because this

carcinogenic response was only

observed at the high dose of 3,000 ppm,

a dose associated with evidence of liver

damage, it is likely that this response

occurred via a non-genotoxic, thresholdbased mechanism. Therefore, EPA is

regulating exposure to metolachlor

using a margin of exposure approach. A

NOEL of 15 mg/kg/day from the 2 year

rat feeding study was determined to be

appropriate for use in the Margin of

Exposure carcinogenic risk assessment.

However, because the chronic reference

dose is lower (9.7 mg/kg/day) than the

oncogenic NOEL (15 mg/kg/day), the

EPA is using the Reference Dose for

quantification of human risk.

H. Aggregate Exposure

1. Dietary exposure. For purposes of

assessing the potential dietary exposure

to metolachlor, aggregate exposure has

been estimated based on the TMRC from

the use of metolachlor in or on raw

agricultural commodities for which

tolerances have been previously

established (40 CFR 180.368). The

incremental effect on dietary risk

resulting from the addition of tomatoes

to the label was assessed by

conservatively assuming that exposure

would occur at the proposed tolerance

level of 0.1 ppm with 100% of the crop

treated. The TMRC is obtained by

multiplying the tolerance level residue

for all these raw agricultural

commodities by the consumption data

which estimates the amount of these

products consumed by various

population subgroups. Some of these

raw agricultural commodities (e.g. corn

forage and fodder, peanut hay) are fed

to animals; thus exposure of humans to

residues in these fed commodities might

result if such residues are transferred to

meat, milk, poultry, or eggs. Therefore,

tolerances of 0.02 ppm for milk, meat

and eggs and 0.2 ppm for kidney and

0.05 ppm for liver have been established

for metolachlor. In conducting this

exposure assessment, it has been

conservatively assumed that 100% of all

raw agricultural commodities for which

tolerances have been established for

metolachlor will contain metolachlor

residues and those residues would be at

the level of the tolerance--which results

in an overestimation of human

exposure.

2. Drinking water. Another potential

source of exposure of the general

population to residues of pesticides are

residues in drinking water. Based on the

available studies used by EPA to assess

environmental exposure, it is not

anticipated that exposure to residues of

metolachlor in drinking water will

exceed 20% of the RfD (0.02 mg/kg/

day), a value upon which the Health

Advisory Level of 70 ppb for

metolachlor is based. In fact, based on

experience with metolachlor, it is

believed that metolachlor will be

infrequently found in groundwater (less

than 5% of the samples analyzed), and

when found, it will be in the low ppb

range.

3. Non-dietary exposure. Although

metolachlor may be used on turf and

ornamentals in a residential setting, that

use represents less than 0.1 percent of

the total herbicide market for residential

turf and landscape uses. Currently, there

are no acceptable, reliable exposure data

available to assess any potential risks.

However, given the small amount of

material that is used, it is concluded

that the potential for non-occupational

exposure to the general population is

unlikely.

I. Cumulative Effects

The potential for cumulative effects of

metolachlor and other substances that

have a common mechanism of toxicity

has also been considered. It is

concluded that consideration of a

common mechanism of toxicity with

other registered pesticides in this

chemical class (chloroacetamides) is not

appropriate. Since EPA itself has

concluded that the carcinogenic

potential of metolachlor is not the same

as other registered chloroacetamide

herbicides, based on differences in

rodent metabolism (EPA Peer Review of

metolachlor, 1994), it is believed that

only metolachlor should be considered

in an aggregate exposure assessment.

J. Safety Determinations

1. U.S. population in general. Using

the conservative exposure assumptions

described above, based on the

completeness and reliability of the

toxicity data, it is concluded that

aggregate exposure to metolachlor will

utilize 1.4 percent of the RfD for the

U.S. population. EPA generally has no

concern for exposures below 100

percent of the RfD because the RfD

represents the level at or below which

daily aggregate dietary exposure over a

lifetime will not pose appreciable risks

to human health. Therefore, it is

concluded that there is a reasonable

certainty that no harm will result from

aggregate exposure to metolachlor or

metolachlor residues.

2. Infants and children. In assessing

the potential for additional sensitivity of

infants and children to residues of

metolachlor, data from developmental

toxicity studies in the rat and rabbit and

a 2–generation reproduction study in

the rat have been considered. The

developmental toxicity studies are

designed to evaluate adverse effects on

the developing organism resulting from

chemical exposure during prenatal

development to one or both parents.

Reproduction studies provide

information relating to effects from

exposure to a chemical on the

reproductive capability of mating

animals and data on systemic toxicity.

Developmental toxicity (reduced

mean fetal body weight, reduced

number of implantations/dam with

resulting decreased litter size, and a

slight increase in resorptions/dam with

a resulting increase in post-implantation

loss) was observed in studies conducted

with metolachlor in rats and rabbits.

The NOEL’s for developmental effects in

both rats and rabbits were established at

360 mg/kg/day. The developmental

effect observed in the metolachlor rat

study is believed to be a secondary

effect resulting from maternal stress

(lacrimation, salivation, decreased body

weight gain and food consumption and

death) observed at the limit dose of

1,000 mg/kg/day.

A 2-generation reproduction study

was conducted with metolachlor at

feeding levels of 0, 30, 300 and 1,000

ppm. The reproductive NOEL of 300

ppm (equivalent to 23.5 to 26 mg/kg/

day) was based upon reduced pup

weights in the F1a and F2a litters at the

1,000 ppm dose level (equivalent to 75.8

to 85.7 mg/kg/day). The NOEL for

parental toxicity was equal to or greater

than the 1,000 ppm dose level. FFDCA

section 408 provides that EPA may

apply an additional safety factor for

infants and children in the case of

threshold effects to account for pre- and

post-natal toxicity and the completeness

of the database. Based on the current

toxicological data requirements, the

database relative to pre- and post-natal
18122 Federal Register / Vol. 62, No. 71 / Monday, April 14, 1997 / Notices

effects for children is complete. Further,

for the chemical metolachlor, the NOEL

of 9.7 mg/kg/day from the metolachlor

chronic dog study, which was used to

calculate the RfD (discussed above), is

already lower than the developmental

NOEL’s of 360 mg/kg/day from the

metolachlor teratogenicity studies in

rats and rabbits. In the metolachlor

reproduction study, the lack of severity

of the pup effects observed (decreased

body weight) at the systemic LOEL

(equivalent to 75.8 to 85.7 mg/kg/day)

and the fact that the effects were

observed at a dose that is nearly 10

times greater than the NOEL in the

chronic dog study (9.7 mg/kg/day)

suggest there is no additional sensitivity

for infants and children. Therefore, it is

concluded that an additional

uncertainty factor is not warranted to

protect the health of infants and

children and that the RfD at 0.1 mg/kg/

day based on the chronic dog study is

appropriate for assessing aggregate risk

to infants and children from use of

metolachlor.

Using the conservative exposure

assumptions described above, the

percent of the RfD that will be utilized

by aggregate exposure to residues of

metolachlor including the proposed use

on tomatoes is 1.1 percent for nursing

infants less than 1 year old, 3.5 percent

for non-nursing infants, 3.0 percent for

children 1 to 6 years old and 2.2 percent

for children 7 to 12 years old. Therefore,

based on the completeness and

reliability of the toxicity data and the

conservative exposure assessment, it is

concluded that there is a reasonable

certainty that no harm will result to

infants and children from aggregate

exposure to metolachlor residues.

K. Estrogenic Effects

Metolachlor does not belong to a class

of chemicals known or suspected of

having adverse effects on the endocrine

system. There is no evidence that

metolachlor has any effect on endocrine

function in developmental or

reproduction studies. Furthermore,

histological investigation of endocrine

organs in the chronic dog, rat and

mouse studies conducted with

metolachlor did not indicate that the

endocrine system is targeted by

metolachlor, even at maximally

tolerated doses administered for a

lifetime. Although residues of

metolachlor have been found in raw

agricultural commodities, there is no

evidence that metolachlor

bioaccumulates in the environment.

[FR Doc. 97–9582 Filed 4–11–97; 8:45 am]

BILLING CODE 6560–50–F

FEDERAL HOUSING FINANCE BOARD

[No. 97–N–2]

Notice of Federal Home Loan Bank

Members Selected for Community

Support Review

AGENCY: Federal Housing Finance

Board.

ACTION: Notice.

SUMMARY: The Financial Institutions

Reform, Recovery, and Enforcement Act

of 1989 added a new Section 10(g) to the

Federal Home Loan Bank Act of 1932

requiring that members of the Federal

Home Loan Bank (FHLBank) System

meet standards for community

investment or service in order to

maintain continued access to long-term

FHLBank System advances. In

compliance with this statutory change,

the Federal Housing Finance Board

(Housing Finance Board) promulgated

Community Support regulations (12

CFR Part 936). Under the review process

established in the regulations, the

Housing Finance Board will select a

certain number of members for review

each quarter, so that all members that

are subject to the Community

Reinvestment Act of 1977, 12 U.S.C.

§ 2901 et seq., (CRA), will be reviewed

once every two years. The purpose of

this Notice is to announce the names of

the members selected for the fifth

quarter review (1996–97 cycle) under

the regulations. The Notice also conveys

the dates by which members need to

comply with the Community Support

regulation review requirements and by

which comments from the public must

be received.

DATES: Due Date For Member

Community Support Statements for

Members Selected in Fifth Quarter

Review: May 29, 1997.

Due Date For Public Comments on

Members Selected in Fifth Quarter

Review: May 29, 1997.

FOR FURTHER INFORMATION CONTACT:

Mitchell Berns, Director, Office of

Supervision, (202) 408–2562, Federal

Housing Finance Board, 1777 F Street,

NW., Washington, DC 20006. A

telecommunications device for deaf

persons (TDD) is available at (202) 408–

2579.

SUPPLEMENTARY INFORMATION:

A. Selection for Community Support

Review

The Housing Finance Board currently

reviews all FHLBank System members

that are subject to CRA approximately

once every two years. Approximately

one-eighth of the FHLBank members in

each district will be selected for review

by the Housing Finance Board each

calendar quarter. To date, only members

that are subject to CRA have been

reviewed. In selecting members, the

Housing Finance Board follows the

chronological sequence of the members’

CRA Evaluations post-July 1, 1990, to

the greatest extent practicable, selecting

one-eighth of each District’s

membership for review each calendar

quarter. However, the Housing Finance

Board will postpone review of new

members until they have been System

members for one year.

Selection for review is not, nor should

it be construed as, any indication of

either the financial condition or

Community Support performance of the

institutions listed.

B. List of FHLBank Members To Be Reviewed in the Fifth Quarter, Grouped by FHLBank District

Member City State

Federal Home Loan Bank of Boston—District 1

P.O. Box 9106

Boston, Massachusetts 02205–9106

Lafayette American Bank and Trust Company ................................................................... Bridgeport ..................................................... CT

People’s Bank ...................................................................................................................... Bridgeport ..................................................... CT

Maritime Bank and Trust Company .................................................................................... Essex ............................................................ CT

Farmington Savings Bank ................................................................................................... Farmington ................................................... CT

Glastonbury Bank & Trust ................................................................................................... Glastonbury .................................................. CT

Savings Bank of Manchester .............................................................................................. Manchester ................................................... CT

Liberty Bank ......................................................................................................................... Middletown ................................................... CT

Naugatuck Savings Bank .................................................................................................... Naugatuck .................................................... CT