76244 Federal Register / Vol. 65, No. 235 / Wednesday, December 6, 2000 / Notices

compared to those described in PP

7F4842.

G. Existing Tolerances

Existing tolerances have been

established for L-glutamic acid, 40 CFR

part 180.1187.

H. International Tolerances

No Codex maximum residue levels

have been established for L-glutamic

acid.

PP 7F4843

In the Federal Register of October 29,

1997 (62 FR 57170, FRL–5751–3) EPA

issued a notice pursuant to section 408

of the FFDCA, 21 U.S.C. 346a(e)

announcing the filing of a pesticide

tolerance petition (PF–772) by Auxein

Corporation. This notice included a

summary of the petition prepared by the

petitioner and this summary contained

conclusions and arguments to support

its conclusion that the petition

complied with the FQPA of 1996. This

petition requested that 40 CFR 180 be

amended by establishing an exemption

from the requirement of a tolerance for

residues of the biological pest control

agent gamma aminobutyric acid in or on

all food commodities. The final rule

exempted the biochemical gamma

aminobutyric acid from the requirement

of a tolerance on all food commodities

when used as a plant growth enhancer

in accordance with good agricultural

practices. EPA published a final rule

establishing a tolerance exemption in

the Federal Register on January 7, 1998

(63 FR 676–679) (FRL–5764–5)

amending 40 CFR 1180.1188. Recent

research performed on this active

ingredient indicates the method of

protection is not restricted to growth

enhancement, and Auxein Corporation

wishes to delete the wording ‘‘when

used as a plant growth enhancer’’ from

the present exemption.

A. Product Name and Proposed Use

Practices

AuxiGro WP Plant Metabolic Primer.

When used as directed, AuxiGro has

been shown to increase yields and/or

quality of treated commodities, early

ripening in certain vegetables, increased

root growth, early flowering and fruit

set, faster seed germination and rooting.

B. Product Identity/Chemistry

1. Identity of the pesticide and

corresponding residues. Supporting data

for this section were submitted with PP

7F4843. Supporting product chemistry

data for the end-use product, AuxiGro

WP (EPA Reg. No. 70810–1) were

submitted on June 12, 1997 (MRID

44296801) and February 16, 1998 (MRID

44538701).

2. Magnitude of residue at the time of

harvest and method used to determine

the residue. Supporting data for this

section were submitted with PP 7F4843.

3. A statement of why an analytical

method for detecting and measuring the

levels of the pesticide residue are not

needed. Supporting data for this section

were submitted with PP 7F4843.

C. Mammalian Toxicological Profile

Supporting data for this section were

submitted with PP 7F4843.

D. Aggregate Exposure

1. Dietary exposure—i. Food. No

differences in exposure are expected

compared to those described in PP

7F4843.

ii. Drinking water. No differences in

exposure are expected compared to

those described in PP 7F4843.

2. Non-dietary exposure. No

differences in exposure are expected

compared to those described in PP

7F4843.

E. Cumulative Exposure

No differences in exposure are

expected compared to those described

in PP 7F4843.

F. Safety Determination

1. U.S. population. Based on its

abundance in nature and long history of

use by humans without deleterious

effects, there is reasonable certainty that

no harm will result from aggregate

exposure to the U.S. population,

including infants and children, to

residues of GABA. This includes all

anticipated dietary exposure and all

other exposures for which there is

reliable information. This is a

reasonable conclusion because exposure

to GABA resulting from label directed

use is inconsequential, does not cross

the blood-brain barrier, and is

consumed daily by the human

population from naturally occurring

sources.

2. Infants and children. No

differences in exposure are expected

compared to those described in PP

7F4843.

G. Existing Tolerances

Existing tolerances have been

extablished for gamma aminobutyric

acid (GABA), 40 CFR part 180.1188.

H. International Tolerances

No Codex maximum residue levels

have been established for gamma

aminobutyric acid (GABA)

[FR Doc. 00–30918 Filed 12–5–00; 8:45a.m.]

BILLING CODE 6560–50–S

ENVIRONMENTAL PROTECTION

AGENCY

[PF–985; FRL–6755–5]

Notice of Filing a Pesticide Petition to

Establish a Tolerance for a Certain

Pesticide Chemical 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 a certain

pesticide chemical in or on various food

commodities.

DATES: Comments, identified by docket

control number PF–985, must be

received on or before January 5, 2001.

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–985 in the subject line on the first

page of your response.

FOR FURTHER INFORMATION CONTACT: By

mail: James Tompkins, Registration

Support Branch, Registration Division

(7505C), Office of Pesticide Programs,

Environmental Protection Agency, 1200

Pennsylvania Ave., NW., Washington,

DC 20460; telephone number: (703)

305–5697; e-mail address:

tompkins.jim@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

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

Federal Register / Vol. 65, No. 235 / Wednesday, December 6, 2000 / Notices 76245

(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–

985. 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

control number PF–985 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, 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–985. 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 establishment

and/or amendment of regulations for

residues of a certain pesticide chemical

in or on various food commodities

under section 408 of the Federal Food,

Drug, and Comestic Act (FFDCA), 21

U.S.C. 346a. EPA has determined that

this petition contains data or

information regarding the elements set

forth in section 408(d)(2); however, EPA

has not fully evaluated the sufficiency

of the submitted data at this time or

whether the data support 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: November 21, 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 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.

76246 Federal Register / Vol. 65, No. 235 / Wednesday, December 6, 2000 / Notices

Dow AgroSciences

PP 4F4412

EPA has received a pesticide petition

(PP 4F4412) from Dow AgroSciences,

9330 Zionsville Road, Indianapolis, IN

46268–1054 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 extending the time–limited

tolerance for residues of picloram, 4-

amino-3,5,6-trichloropicolinic acid and

its potassium salt in or on in or on the

raw agricultural commodities (RACs)

sorghum grain at 0.3 parts per million

(ppm), sorghum grain forage at 0.2 ppm,

and sorghum stover at 0.5 ppm; and for

residues of picloram in or on the RAC

aspirated grain fractions at 4 ppm until

December 31, 2002. EPA issued a final

rule, published in the Federal Register

of January 5, 1999 (64 FR 418) (FRL–

6039–4), which announced that it

established a time–limited tolerance for

the indirect or inadvertent residues of

the herbicide picloram, 4-amino-3,5,6-

trichloropicolinic acid and its

potassium salt in or on sorghum grain

at 0.3 ppm, sorghum grain forage at 0.2

ppm, and sorghum stover at 0.5 ppm;

and for residues of picloram in or on the

RAC aspirated grain fractions at 4 ppm,

with an expiration date of December 31,

2000. A condition of this rule required

Dow AgroSciences to submit an

aspirated grain residue study before

December 31, 1999, which they did on

December 9, 1999. The extension of the

time–limited tolerances to December 31,

2002 will allow time for review of this

additional data and establishment of

final tolerances. EPA has determined

that the petition contains data or

information regarding the elements set

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

however, EPA has not fully evaluated

the sufficiency of the submitted data at

this time or whether the data supports

granting of the petition. Additional data

may be needed before EPA rules on the

petition.

A. Residue Chemistry

1. Plant metabolism. The qualitative

nature of the residue in plants is

understood based on a wheat

metabolism study. The residue of

concern in wheat forage, straw and grain

is conjugated picloram, which is

hydrolyzable by acid, base and Bglucosidase. The minor metabolites that

were identified in grain and straw were

4-amino-6-hydroxy-3,5-

dichloropicolinic acid and 4-amino2,3,5-trichloropyridine.

2. Analytical method. The analytical

portions of the magnitude of residue

studies were performed at Dow

AgroSciences in Midland, MI. The

analytical method utilized for the

determination of picloram residue levels

in the submitted studies was ACR

73.3.S2. There is a practical analytical

method for detecting and measuring

levels of picloram in or on food with a

limit of quantitation that allows

monitoring of food with residues at or

above the levels set in these tolerances.

EPA has provided information on this

method to FDA. The method is available

to anyone who is interested in pesticide

residue enforcement.

3. Magnitude of residues

TABLE 1.–SUMMARY OF RESIDUES OF

PICLORAM (PPM) FOUND IN GRAIN

SORGHUM

Matrix Range

Grain ND a-0.23

Forage ND-0.17

Fodder ND-0.44

Aspirated grain fractionsND

a ND = less than one–half of the validated

lower limit of quantitation of 0.05 μg/g in grain,

0.1 μg/g in forage and fodder, and 0.25 μg/g

in aspirated grain fractions.

B. Toxicological Profile

1. Acute toxicity. Studies for acute

toxicity indicate that picloram is

classified as category III for acute oral

toxicity, category III for acute dermal

toxicity, category I/II (depending on

whether acid or salts) for acute

inhalation toxicity, category IV for skin

irritation potential, and category III for

eye irritation potential. The potassium

salt is classified as a skin sensitizer. In

addition, picloram has a low vapor

pressure.

Picloram potassium salt has low acute

toxicity. The rat oral LD50 is 3,536

milligram/kilogram (mg/kg) or greater

for males and females. The rabbit

dermal LD50 is > 2,000 mg/kg and the rat

inhalation LC50 is > 1.63 milligram/liter

(mg/L) air (the highest attainable

concentration). Picloram potassium salt

is a positive skin sensitizer in guinea

pigs but is not a dermal irritant.

Technical picloram potassium salt is a

moderate ocular irritant but ocular

exposure to the technical material

would not normally be expected to

occur to infants or children or the

general public. End use formulations of

picloram have similar low acute toxicity

profiles plus low ocular toxicity as well.

Therefore, based on the available acute

toxicity data, picloram does not pose

any acute dietary risks.

2. Genotoxicty. Picloram acid was

evaluated in the Ames test using

Salmonella typhimurium. Doses ranged

up to 5,000 μ g/plate, with and without

metabolic activation. The test substance

did not produce a mutagenic response

either in the presence or absence of

activation.

Picloram acid was evaluated for gene

mutation in mammalian cells (HGPRT/

CHO). As evaluated up to toxic levels

(1,750 gram/milliliter (μg/mL) without

metabolic activation; 4,500 μg/mL with

metabolic activation), the compound

was found to be negative for inducing

forward mutation in Chinese hamster

ovary (CHO) cells.

Picloram acid was evaluated for

cytogenetic effects on bone marrow cells

of rats via intra gastric administration at

dosage levels of 0 (vehicle), 20, 200 or

2,000 mg/kg. The test material did not

produce cytogenetic effects in the study.

Picloram acid was evaluated for

genotoxic potential as administered to

primary rat hepatocyte cultures at

concentrations of 0 (vehicle), 10, 33.3,

100, 333.3 or 1,000 g/mL. The test

material was negative for unscheduled

DNA synthesis (UDS, a measure of DNA

damage/repair) treated up to cytotoxic

levels of (1,000 μg/mL).

3. Reproductive and developmental

toxicity. The HED RfD Peer Review

Committee concluded that there was no

evidence, based on the available data,

that picloram and its salts were

associated with significant reproductive

or developmental toxicity under the

testing conditions.

In the following developmental

toxicity studies, the dose levels that

appear in parenthesis are picloram acid

equivalents where the conversion factor

employed was 0.86 as applied to doses

of potassium salt.

Picloram potassium salt was

administered to New Zealand rabbits by

oral gavage at dosage levels of 0, 40,

200, and 400 mg/kg/day (picloram acid

equivalents) during days 6 to 18 of

gestation. The maternal no observed

adverse effect level (NOAEL) is 40 (34)

mg/kg/day, where the lowest observed

adverse effect level (LOAEL) is 200

(172) mg/kg/day based on reduced

maternal weight gain during gestation.

The developmental NOAEL is 400 (340)

mg/kg/day and the LOAEL was not

determined. The potassium salt of

picloram was administered to CD rats by

gastric intubation at dosage levels of 0,

35 (30), 174 (150) and 347 (298) mg/kg/

day during day 6–15 of gestation. The

test vehicle was distilled water. There

was no evidence of developmental

toxicity at doses up to and including the

high dose of 347 (298) mg/kg/day. The

maternal LOAEL is 347 (298) mg/kg/day

based upon excessive salivation in the

dams of the high dose group. Hence, the

developmental toxicity NOAEL is

Federal Register / Vol. 65, No. 235 / Wednesday, December 6, 2000 / Notices 76247

greater than or equal to 347 (298) mg/

kg/day. The maternal toxicity LOAEL is

347 (298) mg/kg/day and NOAEL is 174

(150) mg/kg/day.

Picloram acid was evaluated in a 2–

generation reproduction study in the CD

rat. Dosage levels employed were 0, 20,

200 or 1,000 mg/kg/day. The parental

LOAEL is 1,000 mg/kg/day based on

histopathological lesions in the kidney

of males of both generations and some

females. In males of both generations,

blood in the urine, decreased urine

specific gravity, increased absolute and

relative kidney weight, and increased

body weight gain was observed at the

high dose. The parental LOAEL is 1,000

mg/kg/day and the NOAEL is 200 mg/

kg/day. The reproductive LOAEL was

not identified and the NOAEL is 1,000

mg/kg/day.

4. Subchronic toxicity. In a 90–day

oral toxicity study, picloram acid was

administered via the diet to groups of 15

F344 rats/sex/dose at dosage levels of 0,

15, 50, 150, 300, or 500 mg/kg/day.

Based upon liver weight changes and

minimal microscopic changes in the

liver, the systemic LOAEL is 150 mg/kg/

day. The NOAEL is 50 mg/kg/day.

In a 1982 6–month dog dietary study,

picloram acid was evaluated at dosage

levels of 0, 7, 35 or 175 mg/kg/day. The

systemic NOAEL is 35 mg/kg/day and

the LOAEL is 175 mg/kg/day based on

decreases in body weight gain and food

consumption and increases in liver

weights (relative), alkaline phosphatase

and alanine transaminase. Increased

liver to body weight ratios and absolute

liver weights were observed in only two

males at the 35 mg/kg/day dosage level.

In a 21–day dermal toxicity study, the

potassium salt of picloram was

administered dermally to groups of five

New Zealand white rabbits of each sex

at doses of (vehicle control) 0, 75.3, 251,

or 753 mg/kg/day (0, 65, 217, or 650 mg/

kg/day picloram acid equivalents) for a

total of 15 applications over the 21–day

period. The NOAEL is greater than or

equal to 753 mg/kg/day for both sexes;

hence, a LOAEL was not established for

either sex. Although the limit dose of

1,000 mg/kg/day was not achieved,

practical difficulties precluded

administering more test material. The

study revealed the non–systemic effects

of dermal irritation and very slight to

well defined edema and/or erythema in

both sexes at all dose levels.

5. Chronic toxicity. In a 1988 1–year

chronic feeding study in the dog,

picloram acid was administered orally

via the diet at dosage levels of 0, 7, 35,

or 175 mg/kg/day. The LOAEL is 175

mg/kg/day based on increased liver

weight (absolute and relative). The

NOAEL is 35 mg/kg/day.

In a chronic toxicity/carcinogenicity

feeding study conducted in the F344 rat,

picloram acid (technical grade 93%

containing 197 ppm hexachlorobenzene

as an impurity) was evaluated at 0, 20,

60, or 200 mg/kg/day for two years. The

chronic toxicity LOAEL was 60 mg/kg/

day as evidenced by altered size and

tinctorial properties of centrilobular

hepatocytes and increased absolute and/

or relative liver weights in both sexes.

The NOAEL was 20 mg/kg/day. The

study was negative for carcinogenicity,

but due to concerns that a MTD may not

have been achieved and the fact that the

test material contained 197 ppm

hexachlorobenzene impurity, the study

was not considered to fulfill adequately

the carcinogenicity testing requirement.

In response to the deficiencies cited

in the study above, an additional 2–year

dietary chronic/carcinogenicity study

was conducted (in 1992) using F344 rats

administered picloram acid at dosage

levels of 0, 250, or 500 mg/kg/day for

104 weeks. Chronic toxicity was

observed at 250 mg/kg/day among males

only (increased incidence and severity

of glomerulonephritis, blood in urine,

decreased specific gravity of urine,

increased size of hepatocytes that often

had altered staining properties). Among

females, there were chronic effects only

at 500 mg/kg/day (increased

glomerulonephropathy, increased

absolute and relative kidney weight).

There was no evidence of

carcinogenicity in this study. It should

be noted that use of the Osborne–

Mendel rat was waived due to lack of

availability of the strain of rat. In

addition, the level of

hexachlorobenzene in the test material

employed in this study was 12 ppm.

These two studies fulfill the guidelines

83–l(a) and 83–2(a) for rats.

In a 1992 2–year dietary

carcinogenicity study in B6C3F1 mice,

picloram acid was evaluated at doses of

0, 100, 500, or 1,000 mg/kg/day. The

systemic NOAEL in this study is 500

mg/kg/day based on a significant

increase in absolute and relative kidney

weights in males (at the high dose

level). No histopathological lesions were

found to corroborate these changes.

There was no evidence of

carcinogenicity.

The dose levels tested in the 1992

carcinogenicity studies in rats and mice

were considered adequate for

carcinogenicity testing. The treatment

did not alter the spontaneous tumor

profile in mice or different strains of rats

tested under the testing conditions. The

chemical was classified as a ‘‘Group E

- Evidence of Non–Carcinogenicity for

Humans.’’ This classification applies to

the picloram acid and potassium salt

forms for which acceptable

carcinogenicity studies were available

for review by the HED Carcinogenicity

Peer Review Committee (May 26, 1988).

Using its Guidelines for Carcinogen

Risk Assessment published September

24, 1986 (51 FR 33992), picloram is

classified as Group ‘‘E’’ for

carcinogenicity (no evidence of

carcinogenicity) based on the results of

the carcinogenicity studies. The dose

levels tested in the 1992 carcinogenicity

studies in rats and mice were

considered adequate for carcinogenicity

testing. The treatment did not alter the

spontaneous tumor profile in mice or

different strains of rats tested under the

testing conditions. The chemical was

classified as a ‘‘Group E - Evidence of

Non–Carcinogenicity for Humans.’’ This

classification applies to the picloram

acid and potassium salt forms for which

acceptable carcinogenicity studies were

available for review by the HED

Carcinogenicity Peer Review Committee

May 26, 1988). Thus, a cancer risk

assessment would not be appropriate.

Hexachlorobenzene (HCB), a

recognized impurity in picloram

compounds, is considered to be an

animal carcinogen and probable human

carcinogen as discussed in the 1988

Registration Standard for picloram. The

Q* is 1.02 (mg/kg/day)–1. The maximum

level of HCB in picloram is considered

to be 0.005%.

6. Animal metabolism. The

absorption, distribution, metabolism

and excretion of picloram acid was

evaluated in female rats administered a

single i.v. or oral gavage dose of 10 mg/

kg, an oral gavage dose of 1,000 mg/kg

14C–picloram, or 1 mg/kg/day unlabeled

picloram by gavage for 14 days followed

by a single oral gavage dose of 10 mg/

kg 14C–picloram on day 15. The study

demonstrates that 14C–picloram is

rapidly absorbed, distributed and

excreted following oral and i.v.

administration. This study alone is not

adequate; however, this study is

acceptable when considered in

conjunction with a male rat metabolism

study which yielded similar results.

7. Endocrine disruption. An

evaluation of the potential effects on the

endocrine systems of mammals has not

been determined. However, no evidence

of such effects were reported in the

chronic or reproductive toxicology

studies described above. There was no

observed pathology of the endocrine

organs in these studies. There is no

evidence at this time that picloram

causes endocrine effects.

C. Aggregate Exposure

1. Dietary exposure.–i. Food. For

purposes of assessing the potential

76248 Federal Register / Vol. 65, No. 235 / Wednesday, December 6, 2000 / Notices

dietary exposure under these tolerances,

aggregate exposure is estimated based

on the TMRC from the existing and

future potential tolerances for picloram

on food crops. The TMRC is obtained by

multiplying the tolerance level residues

(existing and proposed) by the

consumption data which estimates the

amount of those food products eaten by

various population subgroups. Exposure

of humans to residues could also result

if such residues are transferred to meat,

milk, poultry or eggs. The following

assumptions were used in conducting

the HED exposure assessment: 100% of

the crops were treated, the RAC residues

would be at the level of the tolerance,

and some refinements were made based

on marketing information previously

supplied to HED by BEAD. This

screening level analysis results in an

overestimate of human exposure and a

conservative assessment of risk.

The chronic dietary exposure/risk

estimates for picloram are extremely

low. For the United States population as

a whole, the Theoretical Maximum

Residue Contribution (TMRC) is 0.0011

mg/kg bw/day, < 1 of the reference dose

(RfD). The subgroup with the greatest

routine chronic exposure is Non–

nursing Infants (Less Than 1–Year Old),

which has a TMRC of 0.0042 mg/kg bw/

day (2% of the RfD).

There is currently no form of sorghum

observed in human consumption

surveys utilized by EPA in their dietary

risk evaluation model (DRES)

assessments. Furthermore, residues of

picloram in sorghum do not increase the

dietary burden of picloram in animal

feeds. Therefore, sorghum tolerances

will have no effect on the human dietary

consumption of picloram, and the

proposed action, as well as existing

tolerances, pose no concern with

regards to chronic dietary exposure to

food residues of picloram.

The estimated carcinogenic dietary

risk for HCB as an impurity in picloram

only for the U.S. population is 1.5 X10–

7 which is less than the 1.0 X10–6 point

below which risk is generally

considered to be negligible.

ii. Drinking water. An additional

potential source of dietary exposure to

residues of pesticides are residues in

drinking water. The Maximum

Contaminant Level for residues of

picloram in drinking water has been

established at 500 μg/L and a 1–10 day

Health Advisory of 20,000 μg/L.

The Agency has published screening

methods for estimating chemical

residues in both ground water (SCI–

GROW2) and surface water (GENEEC).

Employing these methods yields the

following 56–day Expected

Environmental Concentrations (EEC) for

a range of application rates:

TABLE 2.–EXPECTED ENVIRONMENTAL CONCENTRATIONS

Application rate (lb. acidequivalent/acre) and

use SCI–GROW2EEC (μg/L) GENEECEEC (μg/L)

0.023 (wheat, barley,and oats use rate) 4.4 1.2

1 (maximum broadcastrate in label) 189 51.3

2(maximum spottreatment rate in label) 379 103.1

The 56–day value is an appropriate

endpoint to employ for the chronic

exposure scenario. Default, conservative

inputs were used for the models, as

described in July 27, 1998 memorandum

from EPA to Dow AgroSciences.

Employing these values, a worst–case

drinking water risk assessment can be

performed as summarized below:

TABLE 3.–DRINKING WATER RISK ASSESSMENT

Population subgroup1 RfD (mg/kg/

day)

Food exposure (mg/kg/

day)

Maximum water

exposure(mg/

kg/day)2

DWLOC(μg/L)3 SCI–GROW2EEC (μg/L) GENEEC EEC

(μg/L)

U.S population 0.2 0.0011 0.2 7,000 379 103.1

Females(13–19, not nursing orpregnant)0.2 0.00090 0.2 6,000 379 103.1

Non–Nursing infants(< 1

yr. old)

0.2 0.0043 0.2 2,000 379 103.1

1 Population subgroups chosen in EPA memorandum of July/27/98. 2=RfD - ARC from DRES (cited above)

3 Drinking water level of concern, based on default water body weights and water consumption of: 70 kg/2L (adult males), 60 kg/2L (adult female), 10 kg/1L (infant).

This tables shows that for even the

most highly exposed population,

exposure from water is below HED’s

DWLOC for chronic dietary exposure.

Further refinement is also possible

based on monitoring data. Monitoring

data available from the Pesticides in

Ground Water Data base indicate that

picloram has been detected in ground

water at concentrations ranging up to 30

μg/L. Results reported in this database

typically were focused on highly

vulnerable areas and, in many cases, the

database reports information from

poorly constructed or damaged wells.

These wells are at high risk because of

the potential for surface residues to be

carried directly down the casing into the

ground water. Recognizing these high

risk situations, an analysis of this

database shows that less than 3% of the

wells sampled were found to contain

picloram. No distinction has been made

between point and non point sources of

material. Many of the detections are

known to be related to point source

contamination including spills at

mixing/loading sites, near wells and

back siphoning events. Of the detections

which may have resulted from non–

point sources, none are documented to

occur on sites where application would

be recommended based on current

labeling. Nearly 99% of the ground

water detections are at levels of less

than 1% of the Maximum Contaminant

Level (i.e., <5 μg/L) established for

human consumption by the EPA Office

of Drinking Water. The STORET data

base maintained by the USEPA Office of

Drinking Water indicates that picloram

has been reported in surface water

Federal Register / Vol. 65, No. 235 / Wednesday, December 6, 2000 / Notices 76249

samples before 1988. Of these

detections, 85% were at concentrations

0.13 μg/L or lower and the maximum

was 4.6 μg/L. The maximum

concentration reported was 4.6 μg/L.

Comparing these values to the DWLOC

shows an even greater degree of

protection for all of the population

subgroups.

HCB contamination of ground water

resources is relatively unlikely due to its

high binding potential. Based on

monitoring data and fate properties it is

unlikely that long term HCB

concentrations in surface water would

exceed 10 ppt. Therefore, exposure from

water is below EPA’s drinking water

level of concern of 34 ppt for chronic

dietary exposure to HCB for the U.S.

population.

In summary, these data on potential

water exposure indicate insignificant

additional dietary intake and risk for

picloram.

2. Non–dietary exposure. This is a

restricted use chemical that has no

residential uses at this time; therefore,

there are no human risks associated

with residential uses. Entry into a

treated area soon after the application of

picloram is expected to be rare given the

cultural practices typically associated

with the use sites (rights–of–way,

forestry, pastures, range lands, and

small grains) defined by the picloram

labels at this time. Furthermore, if entry

should occur, the potential exposures

are expected to be minimal due to the

characteristics of those use–sites.

D. Cumulative Effects

The potential for cumulative effects of

picloram and other substances that have

a common mechanism of toxicity was

considered. The mammalian toxicity of

picloram is well defined. However, the

biochemical mechanism of toxicity of

this compound is not well known. No

reliable information exists to indicate

that toxic effects produced by picloram

would be cumulative with those of any

other chemical compounds. Therefore,

consideration of a common mechanism

of toxicity with other compounds is not

appropriate. Thus, only the potential

risks of picloram are considered in the

aggregate exposure assessment.

E. Safety Determination

1. U.S. population. In the meeting of

September 30, 1993, the OPP RfD Peer

Review Committee recommended that

the RfD for this chemical be based on a

NOAEL of 20 mg/kg/day for a dose–

related increase in size and altered

tinctorial properties of centrilobular

hepatocytes in males and females at 60

and 200 mg/kg/day in a chronic toxicity

study in rats. An uncertainty factor (UF)

of 100 was used to account for the inter–

species extrapolation and intra–species

variability. On this basis, the RfD was

calculated to be 0.20 mg/kg/day. The

theoretical maximum residue

contribution (TMRC) from existing

tolerances is 0.001845 mg/kg/day.

Existing tolerances utilize < 1% of the

RfD. It should be noted that no

regulatory value has been established

for this chemical by the World Health

Organization (WHO) up to this date. The

committee classified picloram as a

‘‘Group E’’ chemical, no evidence of

carcinogenicity for humans.

Using the conservative exposure

assumptions described above and based

on the completeness and reliability of

the toxicity data, it is concluded that

aggregate exposure to picloram will

utilize approximately 1% of the RfD for

the U.S. population. Generally,

exposures below 100% of the RfD are of

no concern because the RfD represents

the level at or below which daily

aggregate dietary exposure over a

lifetime will not pose appreciable risk to

human health. Thus, there is a

reasonable certainty that no harm will

result from aggregate exposure to

picloram residues.

2. Infants and children. In assessing

the potential for additional sensitivity of

infants and children to residues of

picloram, data from developmental

toxicity studies in the rat and rabbit and

a 2–generation reproduction study in

the rat were considered. The

developmental toxicity studies are

designed to evaluate adverse effects on

the developing organism during

prenatal development resulting from

pesticide exposure to one or both

parents. Reproduction studies provide

(i) information relating to effects from

exposure to the pesticide on the

reproductive capability of mating

animals and (ii) data on systemic

toxicity.

Developmental toxicity was studied

using rats and rabbits. The

developmental study in rats resulted in

a developmental NOAEL of > 298 mg/

kg/day and a maternal toxicity NOAEL

of 280 mg/kg/day. A study in rabbits

resulted in a maternal NOAEL of 34 mg/

kg/day and a developmental NOAEL of

344 mg/kg/day. Based on all of the data

for picloram, there is no evidence of

developmental toxicity at dose levels

that do not result in maternal toxicity.

In a 2–generation reproduction study

in rats, the NOAEL for parental systemic

toxicity is 200 mg/kg/day. There was no

effect on reproductive parameters at

1,000 mg/kg/day, nor was there an

adverse effect on the morphology,

growth or viability of the offspring.

Thus, the reproductive NOAEL is 1,000

mg/kg/day.

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–

natal and post–natal toxicity and the

completeness of the data base. Based on

the current toxicological data

requirements, the data base relative to

pre–natal and post–natal effects for

children is complete. Therefore, it is

concluded that an additional UF is not

warranted and that the RfD at 0.2 mg/

kg/day is appropriate for assessing

aggregate risk to infants and children.

Using the conservative exposure

assumption previously described, it is

concluded that the percent of the RfD

that will be utilized by aggregate

exposure to residues of picloram will be

less than 4% of the RfD for all

populations and subgroups. Since this

estimate represents the ‘‘worst case’’

exposure for a given population (Non–

nursing infants, < 1 year old), exposures

will be less for all other sub–

populations, e.g., children, 1–6 years.

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 picloram residues.

F. International Tolerances

There are no Codex maximum residue

levels established for residues of

picloram.

[FR Doc. 00–31057 Filed 12–5–00; 8:45 am]

BILLING CODE 6560–50–S

ENVIRONMENTAL PROTECTION

AGENCY

[PF–984; FRL–6755–4]

Notice of Filing a Pesticide Petition to

Establish a Tolerance for a Certain

Pesticide Chemical 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 a certain

pesticide chemical in or on various food

commodities.

DATES: Comments, identified by docket

control number PF–984, must be

received on or before January 5, 2001.

ADDRESSES: Comments may be

submitted by mail, electronically, or in

person. Please follow the detailed