31904 Federal Register / Vol. 65, No. 98 / Friday, May 19, 2000 / Notices

II. What Action is the Agency Taking?

EPA is making available preliminary

risk assessments that have been

developed as part of EPA’s process for

making reregistration eligibility

decisions for the organophosphate

pesticides and for tolerance

reassessments consistent with the

FFDCA, as amended by the FQPA. The

Agency’s preliminary human health and

ecological risk assessments for one

organophosphate pesticide are available

in the individual organophosphate

pesticide docket: Diazinon.

Included in the individual

organophosphate pesticide docket is the

Agency’s preliminary risk assessments.

As additional comments, reviews, and

risk assessment modifications become

available, these will also be docketed for

the one organophosphate pesticide

listed in this notice. The Agency

cautions that these risk assessments are

preliminary assessments only and that

further refinements of the risk

assessments will be appropriate for the

one organophosphate pesticide. These

documents reflect only the work and

analysis conducted as of the time they

were produced and it is appropriate

that, as new information becomes

available and/or additional analyses are

performed, the conclusions they contain

may change.

As the preliminary risk assessments

for the remaining organophosphate

pesticides are completed and registrants

are given a 30-day review period to

identify possible computational or other

clear errors in the risk assessments,

these risk assessments and registrant

responses will be placed in the

organophosphate pesticide docket for

diazinon. A notice of availability for

subsequent assessments will appear in

the Federal Register.

The Agency is providing an

opportunity, through this notice, for

interested parties to provide written

comments and data and input to the

Agency on the preliminary risk

assessments for the chemical specified

in this notice. Such comments and data

and input could address, for example,

the availability of additional data to

further refine the risk assessments, such

as percent crop treated information or

submission of residue data from food

processing studies, or could address the

Agency’s risk assessment methodologies

and assumptions as applied to this

specific chemicals. Comments and data

should be limited to issues raised

within the preliminary risk assessments

and associated documents. EPA will

provide other opportunities for public

comment and data on other science

issues associated with the

organophosphate pesticide tolerance

reassessment program. Failure to

comment on any such issues as part of

this opportunity will in no way

prejudice or limit a commenter’s

opportunity to participate fully in later

notice and comment processes. All

comments and data should be submitted

by July 18, 2000 at the address given

under Unit I. Comments and data will

become part of the Agency record for

this organophosphate pesticide.

List of Subjects

Environmental protection, Chemicals,

Pesticides and pests.

Dated: May 16, 2000.

Jack E. Housenger,

Acting Director, Special Review and

Reregistration Division, Office of Pesticide

Programs.

[FR Doc. 00–12676 Filed 5–18–00; 8:45 am]

BILLING CODE 6560–50–F

ENVIRONMENTAL PROTECTION

AGENCY

[PF–943; FRL–6558–2]

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 a pesticide petition

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–943, must be

received on or before June 19, 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–943 in the subject line on the first

page of your response.

FOR FURTHER INFORMATION CONTACT: By

mail: Joanne I. Miller, Registration

Division (7505C), Office of Pesticide

Programs, Environmental Protection

Agency, Ariel Rios Bldg., 1200

Pennsylvania Ave., NW., Washington,

DC 20460; telephone number: (703)

305–6224; e-mail address:

miller.joanne@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:

Categories NAICS 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–

943. 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

Federal Register / Vol. 65, No. 98 / Friday, May 19, 2000 / Notices 31905

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, 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–943 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, Ariel Rios Bldg., 1200

Pennsylvania Ave., NW., 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, Crystal

Mall #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–943. 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

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 a pesticide petition

as follows proposing the amendment of

the regulation for residues of

glufosinate-ammonium, a pesticide

chemical, in or on food commodities

derived from cotton under section 408

of the Federal Food, Drug, and Comestic

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

determined that this request contains

data or information regarding the

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

however, EPA has not evaluated the

submitted data at this time or whether

the data supports granting of the

petition. Additional data may be needed

before EPA rules on the petition.

List of Subjects

Environmental protection,

Agricultural commodities, Feed

additives, Food additives, Pesticides

and pests, Reporting and recordkeeping

requirements.

Dated: May 9, 2000.

James Jones,

Director, Registration Division, Office of

Pesticide Programs.

Summary of Petition

The petitioner summary of the

pesticide petition is printed below as

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

FFDCA. The summary of the petition

was prepared by the petitioner and

represents the view of the petitioners.

EPA is publishing the petition summary

verbatim without editing it in any way.

The summary identifies an analytical

method available to EPA for the

detection and measurement of the

residues of glufosinate-ammonium in or

on cotton commodities.

Aventis CropScience USA

PP 0F6140

EPA has received a pesticide petition

(PP 0F6140) from Aventis CropScience

USA, PO Box 12014, 2 T. W. Alexander

Drive, Research Triangle Park, NC

27709, 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

180.473(a)(1) by establishing tolerances

for residues of the herbicide glufosinateammonium (butanoic acid, 2-amino-4-

(hydroxymethylphosphinyl)-,

monoammonium salt) and its

metabolite, 3-methylphosphinicopropionic acid, expressed as 2-amino-4-

(hydroxymethylphosphinyl)butanoic

acid equivalents in or on the raw

agricultural commodities derived from

cotton: undelinted seed at 3.5 parts per

million (ppm) and gin byproducts at

12.0 ppm. Aventis CropScience also

proposes to amend 40 CFR part

180.473(c) by establishing tolerances for

residues of the herbicide glufosinateammonium (butanoic acid, 2-amino-4-

(hydroxymethylphosphinyl)-,

monoammonium salt) and its

metabolites, 3-methylphosphinicopropionic acid, and 2-acetamido-4-

methylphosphinico-butanoic acid

expressed as 2-amino-4-

(hydroxymethylphosphinyl)butanoic

acid equivalents in or on the raw

agricultural commodities derived from

transgenic cotton tolerant to glufosinateammonium: Undelinted seed at 3.5 ppm

and gin byproducts at 12.0 ppm. EPA

has determined that the petition

contains data or information regarding

the elements set forth in section

408(d)(2) of the FFDCA; however, EPA

has not fully evaluated the sufficiency

of the submitted data at this time or

whether the data supports granting of

31906 Federal Register / Vol. 65, No. 98 / Friday, May 19, 2000 / Notices

the petition. Additional data may be

needed before EPA rules on the petition.

A. Residue Chemistry

1. Plant metabolism. The metabolism

of glufosinate-ammonium in plants has

been investigated and is understood.

The crop residue profile following

selective use of glufosinate-ammonium

on transgenic crops is different from

that found in conventional crops. The

crop residue observed after nonselective use is the metabolite 3-

methylphosphinico-propionic acid

which is found only in trace amounts.

The principal residue identified in the

metabolism studies after selective use of

glufosinate-ammonium on transgenic

crops is the acetylated derivative of

parent material, 2-acetamido-4-

methylphosphinico-butanoic acid with

lesser amounts of 3-methylphosphinicopropionic acid observed.

2. Analytical method. The

enforcement analytical method utilizes

gas chromatography for detecting and

measuring levels of glufosinateammonium and metabolites with a

general limit of quantification of 0.05

ppm. This method allows detection of

residues at or above the proposed

tolerances.

3. Magnitude of residues. Field

residue trials were conducted across the

five major regions of cotton production

in the U.S. Two different treatment

regimes were examined to represent use

patterns which are the most likely to

result in the highest residues.

Glufosinate-ammonium derived

residues did not exceed 3.4 ppm in

undelinted cotton seed and 11.6 ppm in

cotton gin byproducts (trash) when

sampled at 70 days or more after the last

treatment. No significant concentration

of the residues occurred in the

processed cotton commodities meal and

hull and in refined oil the residues were

less than the limit of quantitation (LOQ)

of the analytical method. Thus,

tolerances are not being proposed for

the processed commodities from cotton.

B. Toxicological Profile

1. Acute toxicity. Glufosinateammonium has been classified as

toxicity category III for acute oral,

dermal and inhalation toxicity. It is

toxicity category III for eye irritation. It

is not a dermal irritant (toxicity category

IV) nor is it a dermal sensitizer. The oral

LD50 is 2 gram/kilogram (g/kg) in male

rats and 1.62 g/kg in female rats.

2. Genotoxicity. Based on results of a

complete genotoxicity database, there is

no evidence of mutagenic activity in a

battery of studies, including: Salmonella

spp., E. coli, in vitro mammalian cell

gene mutation assays, mammalian cell

chromosome aberration assays, in vivo

mouse bone marrow micronucleus

assays, and unscheduled DNA synthesis

assays.

3. Reproductive and developmental

toxicity. In a developmental toxicity

study, groups of 20 pregnant female

Wistar rats were administered

glufosinate-ammonium by gavage at

doses of 0, 0.5, 2.24 10, 50 and 250 mg/

kg/day from days 7 to 16 of pregnancy.

The no observed adverse effect level

(NOAEL) for maternal toxicity is 10 mg/

kg/day; the lowest observed adverse

effect level (LOAEL) is 50 mg/kg/day

based on vaginal bleeding and

hyperactivity in dams. In the fetus, the

NOAEL is 50 mg/kg/day, based on

dilated renal pelvis observations at the

LOAEL of 250 mg/kg/day.

In a developmental toxicity study,

groups of 15 pregnant female Himalayan

rabbits were administered glufosinateammonium by gavage at doses of 0, 2.0,

6.3 or 20.0 millgrams/kilogram/day (mg/

kg/day) from days 7 to 19 of pregnancy.

In maternal animals, decreases in food

consumption and body weight gain

were observed at the 20 mg/kg/day dose

level. The NOAEL for both maternal and

developmental toxicity was 6.3 mg/kg/

day.

In a multi-generation reproduction

study, glufosinate-ammonium was

administered to groups of 30 male and

30 female Wistar/Han rats in the diet at

concentrations of 0, 40, 120 or 360 ppm.

The LOAEL for systemic toxicity is 120

ppm based on increased kidney weights

in both sexes and generations. The

systemic toxicity NOAEL is 40 ppm.

The LOAEL for reproductive/

developmental toxicity is 360 ppm

based on decreased numbers of viable

pups in all generations. The NOAEL is

120 ppm.

4. Subchronic toxicity. In a subchronic oral toxicity study, glufosinateammonium was administered to 10

NMRI mice/sex/ dose in the diet at

levels of 0, 80, 320 or 1,280 ppm

(equivalent to 0, 12, 48, or 192 mg/kg/

day) for 13 weeks. Significant (p< 0.05)

increases were observed in serum

aspartate aminotransferase and in

alkaline phosphatase in high-dose (192

mg/kg/day) males. Also observed were

increases in absolute and relative liver

weights in mid-(48 mg/kg/day) and

high-dose males. The NOAEL is 12 mg/

kg/day, the LOAEL is 48 mg/kg/day

based on the changes in clinical

biochemistry and liver weights.

5. Chronic toxicity. In a combined

chronic toxicity/oncogenicity study,

glufosinate-ammonium was

administered to 50 Wistar rats/sex/dose

in the diet for 130 weeks at dose levels

of 0, 40, 140, or 500 ppm (mean

compound intake in males was 0, 1.9,

6.8, and 24.4 mg/kg/day and for females

was 0, 2.4, 8.2 and 28.7 mg/kg/day,

respectively). A dose-related increase in

mortality was noted in females at 140

and 500 ppm, whereas in males

increased absolute and relative kidney

weights were noted at 140 ppm and 500

ppm. The NOAEL was considered to be

40 ppm. No treatment-related oncogenic

response was noted.

In an oncogenicity study, glufosinateammonium was administered to 50

NMRI mice/sex/dose in the diet at dose

levels of 0, 80, 160 (males only) or 320

(females only) ppm for 104 weeks. The

NOAEL for systemic toxicity is 80 ppm

(10.82/16.19 mg/kg/day in males/

females (M/F)), and the LOAEL is 160/

320 ppm (22.60/63.96 mg/kg/day in M/

F), based on increased mortality in

males, increased glucose levels in males

and females, and changes in glutathione

levels in males. No increase in tumor

incidence was found in any treatment

group.

In a chronic feeding study,

glufosinate-ammonium technical was

fed to male and female beagle dogs for

12 months in the diet at levels of 2.0,

5.0 or 8.5 mg/kg/day. The NOAEL is 5.0

mg/kg/day based on clinical signs of

toxicity, reduced weight gain and

mortality 8.5 mg/kg/day.

In a rat oncogenicity study,

glufosinate-ammonium was

administered to Wistar rats (60/sex/

group) for up to 24 months at 0, 1,000,

5,000, or 10,000 ppm (equivalent to 0,

45.4, 228.9, or 466.3 mg/kg/day in males

and 0, 57.1, 281.5, or 579.3 mg/kg/day

in females). The LOAEL for chronic

toxicity is 5,000 ppm (equivalent to

228.9 mg/kg/day for male rats and 281.5

mg/kg/day for females), based on

increased incidences of retinal atrophy.

The chronic NOAEL is 1,000 ppm.

Under the conditions of this study, there

was no evidence of carcinogenic

potential. Dosing was considered

adequate based on the increased

incidence of retinal atrophy.

6. Animal metabolism. Studies

conducted in rats using 14C-glufosinateammonium have shown that the

compound is poorly absorbed (5-10%)

after oral administration and is rapidly

eliminated primarily as the parent

compound. The highest residue levels

were found in liver and kidney tissues.

The metabolic profile and the

quantitative distribution of metabolites

was very similar in both goat and hen.

The vast majority of the dose was

excreted, primarily as parent

compound. The very limited residues

found in edible tissues, milk and eggs

were comprised principally of

glufosinate and 3-methylphosphinicoVerDate 11<MAY>2000 18:59 May 18, 2000 Jkt 190000 PO 00000 Frm 00033 Fmt 4703 Sfmt 4703 E:\FR\FM\19MYN1.SGM pfrm11 PsN: 19MYN1
Federal Register / Vol. 65, No. 98 / Friday, May 19, 2000 / Notices 31907

propionic acid (Hoe 061517), with lesser

amounts of N-acetyl-L-glufosinate (Hoe

099730) and 2-methylohosphinicoacetic acid (Hoe 064619).

7. Metabolite toxicology. Additional

testing has been conducted with the

major metabolites, Hoe 061517 and Hoe

099730, as well as the L-isomer of

glufosinate-ammonium, identified as

Hoe 058192. Based on sub-chronic and

developmental toxicity study results, a

profile of similar or less toxicity

compared to the parent compound,

glufosinate-ammonium, was observed.

8. Endocrine disruption. No special

studies have been conducted to

investigate the potential of glufosinateammonium to induce estrogenic or

other endocrine effects. However, no

evidence of estrogenic or other

endocrine effects have been noted in

any of the toxicology studies that have

been conducted with this product and

there is no reason to suspect that any

such effects would be likely.

C. Aggregate Exposure

1. Dietary exposure. Tolerances have

been established (40 CFR part 180.473)

for the combined residues of

glufosinate-ammonium and metabolites

in or on a variety of raw agricultural

commodities. No appropriate

toxicological endpoint attributable to a

single exposure was identified in the

available toxicity studies. EPA,

therefore, has no, established an acute

reference dose (RfD) for the general

population including infants and

children. An acute RfD of 0.063 mg/kg/

day was established, however, for the

females 13+ subgroup. An acute

analysis was conducted for the subpopulation of females 13+. Chronic

dietary analysis was conducted for the

usual populations.

i. Food. An acute dietary analysis was

conducted using the Dietary Exposure

Evaluation Model (DEEM) software and

the 1994-1996 CSFII consumption data

base. The analysis assumed tolerance

level residues for all commodities and

100% of crop treated. This Tier One

analysis resulted in an exposure of

0.007432 mg/kg bw/day (95th

percentile) for the female 13+ subpopulation (the only population of

concern) representing 35% utilization of

the acute reference dose (RfD).

Chronic dietary analysis was

conducted to estimate exposure to

potential glufosinate-ammonium

residues in or on registered and

proposed commodities. The DEEM

software and the 1994-1996 USDA food

consumption data were used. Tolerance

level residues were assumed for all

commodities and conservative percent

crop treated values were incorporated

for major crops (25% corn, 15%

soybean, 10% potatoes, 20% cotton),

whereas 100% of the crop was assumed

to be treated for all other registered or

pending uses. Chronic dietary exposure

estimates from residues of glufosinateammonium for the US Population

utilized approximately 25% of the

chronic RfD. The sub-population with

the highest exposure was children 1-6

utilizing approximately 67% of the

chronic RfD. This analysis was based on

highly conservative assumptions. The

Agency has no concerns with RfD

utilization up to 100%.

ii. Drinking water. US EPA’s Standard

Operating Procedure (SOP) for Drinking

Water Exposure and Risk Assessments

was used to perform the drinking water

assessment. The models screening

concentrations in ground water (SCIGROW) and EPA’s Pesticide Root Zone

Model (PRZM)-EXAMS were used to

estimate the concentration of

glufosinate-ammonium which might

occur in water. The acute drinking

water level of comparison (DWLOC) for

females 13+ is 408 parts per billion

(ppb). In comparison, the acute drinking

water estimated concentrations (DWEC)

calculated by Generic expected

environmental concentration (GENEEC)

is 45 ppb, nearly an order of magnitude

below the DWLOC.

The chronic DWLOC calculated for

adults is 184 ppb and that for children/

toddlers is 24 ppb. The chronic DWEC

calculated using a worst case scenario is

11 ppb (GENEEC). Thus, the drinking

water estimated concentration

represents only 11% of the DWLOC for

adults and 46% of that for children/

toddlers. The DWLOC are based on

highly conservative dietary (food)

exposures and are expected to be much

higher in real world situations reducing

further the percent utilization of the

DWLOC even more favorable.

2. Non-dietary exposure. Glufosinateammonium is currently registered for

use on the following non-food sites:

areas around ornamentals, shade trees,

Christmas trees, shrubs, walks,

driveways, flower beds, farmstead

buildings, in shelter belts, and along

fences. It is also registered for use as a

post-emergent herbicide on farmsteads,

areas associated with airports,

commercial plants, storage and lumber

yards, highways, educational facilities,

fence lines, ditch banks, dry ditches,

schools, parking lots, tank farms,

pumping stations, parks, utility rightsof-way, roadsides, railroads, and other

public areas and similar industrial and

non-food crop areas. It is also registered

for lawn renovation uses.

The EPA has determined that there

are no acute or chronic non-dietary

exposure scenarios. Further, the Agency

has determined that it is not appropriate

to aggregate short- and intermediateterm non-dietary exposure with dietary

exposures in risk assessments because

the end-points are different.

D. Cumulative Effects

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

when considering whether to establish,

modify, or revoke a tolerance, the

Agency consider ‘‘available

information’’ concerning the cumulative

effects of a particular pesticide’s

residues and ‘‘other substances that

have a common mechanism of toxicity.’’

EPA has indicated that, at this time, the

Agency does not have available data to

determine whether glufosinateammonium has a common mechanism

of toxicity with other substances or how

to include this pesticide in a cumulative

risk assessment. Unlike other pesticides

for which EPA has followed a

cumulative risk approach based on a

common mechanism of toxicity,

glufosinate-ammonium does not appear

to produce a toxic metabolite produced

by other substances. For the purposes of

this tolerance petition, therefore, it has

not been assumed that glufosinateammonium has a common mechanism

of toxicity with other substances.

E. Safety Determination

1. U.S. population. Using the

conservative assumptions described

above, based on the completeness and

reliability of the toxicity data, it is

concluded that chronic dietary exposure

to the registered and proposed uses of

glufosinate-ammonium will utilize at

most 25% of the chronic RfD for the US

Population. The actual exposure is

likely to be much less as more realistic

data and models are developed.

Exposures below 100% of the RfD are

generally assumed to be of no concern

because the RfD represents the level at

or below which daily aggregate

exposure over a lifetime will not pose

appreciable risk to human health.

The acute population of concern,

female 13+ utilizes 35% of the acute

RfD. This is a Tier One highly

conservative assessment and actual

exposure is likely to be far less. DWLOC

based on dietary exposures are greater

than highly conservative estimated

levels, and would be expected to be well

below the 100% level of the RfD, if they

occur at all.

EPA has concluded that it is not

appropriate to aggregate non-dietary

exposures with dietary exposures in a

risk assessment because the toxicity

end-points are different.

Therefore, there is a reasonable

certainty that no harm will occur to the

31908 Federal Register / Vol. 65, No. 98 / Friday, May 19, 2000 / Notices

US Population from aggregate exposure

(food, drinking water and

nonresidential) to residues of

glufosinate-ammonium and metabolites.

2. Infants and children. The

toxicological data base is sufficient for

evaluating prenatal and postnatal

toxicity for glufosinate-ammonium.

There are no prenatal or postnatal

susceptibility concerns for infants and

children, based on the results of the rat

and rabbit developmental toxicity

studies and the 2-generation

reproduction study. Based on clinical

signs of neurological toxicity in short

and intermediate dermal toxicity studies

with rats, EPA has determined that an

added FQPA safety factor of 3x is

appropriate of assessing the risk of

glufosinate-ammonium derived residues

in crop commodities.

Using the conservative assumptions

described in the exposure section above,

the percent of the chronic reference

dose that will be used for exposure to

residues of glufosinate-ammonium in

food for children 1-6 (the most highly

exposed sub group) is 67%. Infants

utilize 43% of the chronic RfD. As in

the adult situation, DWLOC are higher

than the worst case drinking water

estimated concentrations and are

expected to use well below 100% of the

RfD, if they occur at all.

Therefore, there is a reasonable

certainty that no harm will occur to

infants and children from aggregate

exposure to residues of glufosinateammonium.

F. International Tolerances

Maximum residue limits (Codex

MRLs) for glufosinate-ammonium and

metabolites in or on cotton commodities

have not been established by the Codex

Alimentarius Commission.

[FR Doc. 00–12651 Filed 5–18–00; 8:45 am]

BILLING CODE 6560–50–F

ENVIRONMENTAL PROTECTION

AGENCY

[PF–912A; FRL–6559–1]

Amended 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

amended filing of a pesticide petition

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–912A, must be

received on or before June 19, 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 section. To

ensure proper receipt by EPA, it is

imperative that you identify docket

control number PF–912A in the subject

line on the first page of your response.

FOR FURTHER INFORMATION CONTACT: By

mail: Cynthia Giles-Parker, Fungicide

Branch, Registration Division (7505C),

Office of Pesticide Programs,

Environmental Protection Agency, 1200

Pennsylvania Ave., NW., Washington,

DC 20460; telephone number: (703)

305–7740; and e-mail address: gilesparker.cynthia@.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:

Categories NAICS Examples of potentially affected entities

Industry 111

112

311

32532

Crop production

Animal production

Food manufacturing

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 in the FOR FURTHER INFORMATION

CONTACT section.

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–

912A. 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, 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