Federal Register / Vol. 62, No. 70 / Friday, April 11, 1997 / Rules and Regulations 17723

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Parts 180, 185, and 186

[OPP–300469; FRL–5598–6]

Glyphosate; Pesticide Tolerances

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Final rule.

SUMMARY: This rule establishes

permanent tolerances for residues of the

herbicide glyphosate [N-

(phosphonomethyl)glycine] in or on the

raw agricultural commodities (RACs)

corn, field, grain; corn, field, stover;

corn, field, forage; aspirated grain

fractions; sorghum, grain; sorghum,

grain, stover; and oats. The residues

from the treatment of field corn include

residues in or on field corn varieties

which have been genetically modified to

be tolerant of glyphosate. Monsanto

Company submitted petitions to EPA

under the Federal Food, Drug, and

Cosmetic Act (FFDCA) as amended by

the Food Quality Protection Act of 1996

(Pub L. 104–179) requesting the

tolerances.

EFFECTIVE DATES: These regulations

become effective April 11, 1997. Written

objections must be submitted by June

10, 1997.

ADDRESSES: Written objection and

hearing requests, identified by the

docket control number, [OPP–300469;

PP 8F3672, 8F3673, 5F4555, 6E4645],

may be submitted to: Hearing Clerk

(1900), Environmental Protection

Agency, Rm. M3708, 401 M St., SW.,

Washington, DC 20460. Fees

accompanying objections shall be

labeled ‘‘Tolerance Petition Fees’’ and

forwarded to: EPA Headquarters

Accounting Operations Branch, OPP

(Tolerance Fees), P.O. Box 360277M,

Pittsburgh, PA 15251. A copy of any

objections and hearing request filed

with the Hearing Clerk should be

identified by the docket control number

and submitted to: Public Response and

Program Resources Branch, Field

Operations Division (7506C), Office of

Pesticide Programs, Environmental

Protection Agency, 401 M St., SW.,

Washington, DC 20460. In person, bring

a copy of objections and hearing

requests to: Rm. 1132, CM#2, 1921

Jefferson Davis Highway., Arlington, VA

22202.

A copy of objections and hearing

requests filed with the Hearing Clerk

may also be submitted electronically by

sending electronic mail (e-mail) to:

oppdocket@epamail.epa.gov. Copies of

objections and hearing requests must be

submitted as an ASCII file avoiding the

use of special characters and any form

of encryption. Copies of objections and

hearing requests will also be accepted

on disks in WordPerfect in 5.1 file

format or ASCII file format. All copies

of objections and hearing requests in

electronic form must be identified by

the docket number [OPP–300469; PP

8F3672, 8F3673, 5F4555, 6E4645]. No

Confidential Business Information (CBI)

should be submitted through e-mail.

Electronic copies of objections and

hearing requests on this rule may be

filed online at many Federal Depository

Libraries. Additional information on

electronic submission can be found in

Unit XIII. of this document.

FOR FURTHER INFORMATION CONTACT: By

mail, Philip V. Errico, Product Manager,

Registration Division (H7505C), Office

of Pesticide Programs, Environmental

Protection Agency, 401 M St., SW.,

Washington, DC 20460. Office location,

telephone number and e-mail address:

Rm. 241, CM #2, 1921 Jefferson Davis

Highway., Arlington, VA, (703)–305–

6027; e-mail:

errico.philip@epamail.epa.gov.

SUPPLEMENTARY INFORMATION: In the

Federal Register of December 24, 1996

(61 FR 67804)(FRL–5576–6), EPA issued

a Notice of Filing amending petitions PP

8F3672, 8F3673, 5F4555, 6E4645 to

bring the petitions into conformity with

the Food Quality Protection Act (FQPA

of 1996). The notice contained a

summary of the petitions prepared by

the petitioner and the summary

contained conclusions and arguments to

support its conclusion that the petitions

complied with FPQA. In that notice

Monsanto Company, 700 14th Street,

NW., Suite 1100, Washington, DC 20005

proposed amending 40 CFR 180.364 by

establishing a regulation to permit

residues of the herbicide glyphosate (N-

(phosphonomethyl)glycine) resulting

from the application of the

isopropylamine salt and/or the

monoammonium salt of glyphosate in or

on the raw agricultural commodities

(RACs) field corn grain at 1.0 ppm; field

corn forage at 1.0 ppm; field corn fodder

at 100 ppm; aspirated grain fractions at

200 ppm; grain sorghum at 15 ppm;

grain sorghum fodder at 40 ppm; and

oats at 20 ppm. The notice stated that

PP 5F4555 specifically related to field

corn which had been genetically

modified to be tolerant to glyphosate.

The Agency received one comment

opposing the tolerances. The

commentor‘s objection was based on

concerns of (1) Enhanced exposure of

the public to glyphosate and other

ingredients of the Roundup

formulations, (2) greater use of

Roundup/glyphosate which will result

in adverse effects to the environment

and human health, and (3) exposure of

the public to Roundup from

consumption of the corn or the animal

product from animals fed corn. EPA‘s

response to this comment is provided

below.

The Agency determined that the

terminology for field corn grain, field

corn, forage; field corn, fodder;

aspirated grain fractions; grain sorghum,

and grain sorghum, fodder; should be

corrected to read corn, field, grain; corn,

field, stover; corn, field, forage;

aspirated grain fractions; sorghum,

grain; and sorghum, grain, stover; The

subject regulation is therefore amended

accordingly.

The data submitted in the petitions

and other relevant material have been

evaluated. The glyphosate toxicological

data listed below were considered in

support of these tolerances.

I. Toxicological Profile

1. Several acute toxicology studies

placing technical-grade glyphosate in

Toxicity Category III and Toxicity

Category IV. Technical glyphosate is not

a dermal sensitizer.

2. A 1–year feeding study with dogs

fed dosage levels of 0, 20, 100, and 500

milligrams/kilogram/day (mg/kg/day)

with a no-observable-effect level (NOEL)

of 500 mg/kg/day.

3. A 2–year carcinogenicity study in

mice fed dosage levels of 0, 150, 750,

and 4,500 mg/kg/day with no

carcinogenic effect at the highest dose

tested (HDT) of 4,500 mg/kg/day.

4. A chronic feeding/carcinogenicity

study in male and female rats fed dosage

levels of 0, 3, 10, and 31 mg/kg/day

(males) and 0, 3, 11, or 34 mg/kg/day

(females) with no carcinogenic effects

observed under the conditions of the

study at dose levels up to and including

31 mg/kg/day HDT (males) and 34 mg/

kg/day HDT (females) and a systemic

NOEL of 31 mg/kg/day HDT (males) and

34 mg/kg/day HDT (females). Because a

maximum tolerated dose (MTD) was not

reached, this study was classified as

supplemental for carcinogenicity.

5. A chronic feeding/carcinogenicity

study in male and female rats fed dosage

levels of 0, 89, 362, and 940 mg/kg/day

(males) and 1, 113, 457, and 1,183 mg/

kg/day (females) with no carcinogenic

effects noted under the conditions of the

study at dose levels up to and including

940/1,183 mg/kg/day (males/females)

HDT and a systemic NOEL of 362 mg/

kg/day (males) based on an increased

incidence of cataracts and lens

abnormalities, decreased urinary pH,

increased liver weight and increased

liver weight/brain ratio (relative liver
17724 Federal Register / Vol. 62, No. 70 / Friday, April 11, 1997 / Rules and Regulations

weight) at 940 mg/kg/day (males) HDT

and 457 mg/kg/day (females) based on

decreased body weight gain 1,183 mg/

kg/day (females) HDT.

6. A developmental toxicity study in

rats given doses of 0, 300, 1,000, and

3,500 mg/kg/day with a developmental

NOEL of 1,000 mg/kg/day based on an

increase in number of litters and fetuses

with unossified sternebrae, and decrease

in fetal body weight at 3,500 mg/kg/day,

and a maternal NOEL of 1,000 mg/kg/

day based on decrease in body weight

gain, diarrhea, soft stools, breathing

rattles, inactivity, red matter in the

region of nose, mouth, forelimbs, or

dorsal head, and deaths at 3,500 mg/kg/

day HDT.

7. A developmental toxicity study in

rabbits given doses of 0, 75, 175, and

350 mg/kg/day with a developmental

NOEL of 175 mg/kg/day (insufficient

litters were available at 350 mg/kg/day

to assess developmental toxicity); a

maternal NOEL of 175 mg/kg/day based

on increased incidence of soft stool,

diarrhea, nasal discharge, and deaths at

350 mg/kg/day HDT.

8. A multigeneration reproduction

study with rats fed dosage levels of 0,

3, 10, and 30 mg/kg/day with the

parental no-observed-effect level/lowest

observed effect level (NOEL/LOEL) 30

mg/kg/day HDT. The only effect

observed was an increased incidence of

focal tubular dilation of the kidney

(both unilateral and bilateral combined)

in the high-dose male F3b pups. Since

the focal tubular dilation of the kidneys

was not observed at the 1,500 mg/kg/

day level HDT in the rat reproduction

study discussed below, but was

observed at the 30 mg/kg/day level HDT

in the three-generation rat reproduction

study the latter was a spurious rather

than glyphosate-related effect.

Therefore, the parental and reproductive

(pup) NOELs are 30 mg/kg/day.

9. A two generation reproduction

study with rats fed dosage levels of 0,

100, 500, and 1,500 mg/kg/day with a

systemic NOEL of 500 mg/kg/day based

on soft stools in F0 and F1 males and

females at 1,500 mg/kg/day HDT and a

reproductive NOEL 1,500 mg/kg/day

HDT.

10. Mutagenicity data included

chromosomal aberration in vitro (no

aberrations in Chinese hamster ovary

cells were caused with and without S9

activation); DNA repair in rat

hepatocyte; in vivo bone marrow

cytogenic test in rats; rec-assay with B.

subtilis; reverse mutation test with S.

typhimurium; Ames test with S.

typhimurium; and dominant-lethal

mutagenicity test in mice (all negative).

II. Dose Assessment Response

1. Reference Dose (RfD). The RfD

represents the level at or below which

daily aggregate dietary exposure over a

lifetime will not pose appreciable risks

to human health. The RfD is determined

by using the toxicological end point or

the NOEL for the most sensitive

mammalian toxicological study. To

assure the adequacy of the RfD, the

Agency uses an uncertainly factor in

deriving it. The factor is usually 100,

based on the assumption that certain

segments of the human population

could be as much as 100 times more

sensitive than the species represented

by the toxicology. The Agency has

determined a RfD of 2.0 mg/kg/day

based on the maternal toxicity NOEL of

175 mg/kg/day from the developmental

study with rabbits. The LOEL of 350

mg/kg/day HDT was based on treatment

related findings of diarrhea, nasal,

discharge, and death (62.5% of the does

died by gestation day 21).

Developmental toxicity was not

observed at any dose tested.

2. Carcinogenicity classification. The

carcinogenic potential of glyphosate was

first considered by a panel, then called

the Toxicology Branch AD Hoc

Committee, in 1985. The Committee, in

a consensus review dated March 4,

1985, classified glyphosate as a Group C

carcinogen based on an increased

incidence of renal tumors in male mice.

The Committee also concluded that

dose levels tested in the 26–month rat

study were not adequate for assessment

of glyphosate’s carcinogenic potential in

this species. These findings, along with

additional information, including a

reexamination of the kidney slides from

the long-term mouse study, were

referred to the FIFRA Scientific

Advisory Panel (SAP). In its report

dated February 24, 1986, SAP classified

glyphosate as a Group D Carcinogen

(inadequate animal evidence of

carcinogenic potential). SAP concluded

that, after adjusting for the greater

survival in the high-dose mice

compared to concurrent controls, that

no statistically significant pairwise

differences existed, although the trend

was significant.

The SAP determined that the

carcinogenic potential of glyphosate

could not be determined from existing

data and proposed that the rat and/or

mouse studies be repeated in order to

classify these equivocal findings. On

reexamination of all information, the

Agency classified glyphosate as a Group

D Carcinogen and requested that the rat

study be repeated and that a decision on

the need for a repeat mouse study

would be made upon completion of

review of the rat study.

Upon receipt and review of the

second rat chronic feeding/

carcinogenicity study, all toxicological

findings for glyphosate were referred to

the Health Effects Division

Carcinogenicity Peer Review Committee

on June 26, 1991, for discussion and

evaluation of the weight of evidence on

glyphosate with particular emphasis on

its carcinogenic potential. The Peer

Review Committee classified glyphosate

as a Group E (evidence of

noncarcinogenicity for humans), based

upon lack of convincing carcinogenicity

evidence in adequate studies in two

animal species. This classification is

based on the following findings: (1)

None of the types of tumors observed in

the studies (pancreatic islet cell

adenomas in male rat, thyroid c-cell

adenomas and/or carcinomas in male

and female rats, hepatocellular

adenomas and carcinomas in male rats,

and renal tubular neoplasms in male

mice) were determined to be compound

related; (2) glyphosate was tested up to

the limit dose on the rat and up to levels

higher than the limit dose in mice; and

(3) there is no evidence of genotoxicity

for glyphosate.

III. Non-Dietary (Residential and Other

Non-Occupational) Exposure

Assessment

Glyphosate is registered for use on

non-food sites such as around

ornamental, shade trees, shrubs, walks,

driveways, flowerbeds, home lawns,

farmsteads including building

foundations, along and in fences, in dry

ditches and canals, along ditchbanks,

farm roads, shelterbelts, forestry,

Christmas trees, and industrial sites and

other noncrop or industrial areas such

as airports, lumber yards, manufacturing

sites, utility substations, parking areas,

petroleum tank farms, and pumping

station.

Margins of Exposure (MOE’s) are

determined for non-dietary exposure

based on toxicological endpoints and

measured or estimated exposures. Since

glyphosate is a group E chemical

(evidence of non-carcinogenicity for

humans), the 21 day dermal study

lacked any observable effects at the limit

dose, and no adverse effects were

observed in developmental toxicity

studies in rats up to 1,000 mg/kg/day

and rabbits up to 175 mg/kg/day, no

toxicological endpoints are applicable.

Because available data indicated no

evidence of significant toxicity via the

dermal or inhalations routes, MOE‘s

were not calculated and risk

assessments are not required for nonoccupational (residential uses).
Federal Register / Vol. 62, No. 70 / Friday, April 11, 1997 / Rules and Regulations 17725

Some glyphosate end-use products

(non ‘‘homeowner’’ uses only) are in

Toxicity Categories I and II for dermal

and eye irritation and have been

associated with illness or injuries

related to skin or eye irritation. Under

the protective clothing requirements of

the Worker Protection Standards (WPS),

handlers of these products are expected

to be adequately protected.

IV. Dietary Exposure Assessment

The use of a pesticide may result

directly or indirectly, in residues in

food. Primary residues or indirect/

inadvertent residues in the agricultural

commodities harvested from the crop

cultured with the aid of pesticide are

determined by chemical analysis. To

account for the diversity of growing

conditions, culture practices, soil types,

climatic conditions, crop varieties and

method of use of the pesticide, data

from studies that represent the resulting

commodities are collected and

evaluated to determine an appropriate

level of the residue that would not be

exceeded if the pesticide is used as

represented in the studies. Available

field trial data for glyphosate support

these tolerances. However, because of

the recent imposition of additional field

trial data for specific geographical

representation, additional field trial data

are required for corn and grain sorghum.

Because insufficient time has elapsed

since imposition of these requirements

the petitioner is being granted

conditional registrations while

obtaining the data. The conduct of the

field trial and guidelines for

determining the residues are given in

EPA ‘‘OPPTS Test Guidelines, Series

860, Residue Chemistry, August 28,

1996. See Federal Register, 61 FR

44308–44311 for availability of

document.

The nature of the residue in plants

and animals is adequately understood

and consists of the parent, glyphosate.

The Agency has decided that only

glyphosate parent is to be regulated in

plant and animal commodities and that

the major metabolite, AMPA

(aminomethylphosphonic acid) is not of

toxicological concern regardless of its

levels in food.

Secondary residues in animal

commodities are expected from these

uses. However, the established livestock

tolerances are adequate to cover

secondary residues which may result

from feeding field corn (both

conventional and genetically modified),

and sorghum commodities with

residues of glyphosate to animals. Since

no U.S. registration has been proposed

for oats, it has been concluded that oat

feed items are not likely to enter

channels of trades in the United States.

V. International Harmonization

Codex MRL‘s for the residues of

glyphosate exist in maize and the straw

and fodder, dry cereal grains at 0.1 and

100 ppm respectively. Mexican limits

on maize exist at 0.1 ppm. Canadian

limits on all other food crops exist at 0.1

ppm. MRL‘s of 20 ppm, 10 ppm, and 0.1

ppm on oats are established/pending for

CODEX, Canada, and Mexico,

respectively. Codex MRLS were

established based on preplant/

preemergent use of glyphosate and are

identical to the existing tolerances for

these crops under the same us

conditions in the United States. The

increased tolerances now being

proposed on corn and sorghum are

based on new preharvest uses of

glyphosate in the United States. The

import tolerance being proposed for oats

is being proposed to harmonize with

other international MRL’s. The Agency

suggests the petitioner consider

providing all relevant studies to Codex

once the U.S. tolerances are established

in order that the Codex MRLs may be

amended to accommodate the use needs

of the United States.

Adequate enforcement methods are

available for analysis of residues of

glyphosate in or on plant commodities.

These methods include GLC (Method I

in Pesticides Analytical Manual (PAM)

II; the limit of detection is 0.05 ppm).

and HPLC with fluormetric detection.

Use of the GLC method is being

discouraged due to lengthiness of the

procedure. The HPLC method has

undergone successful Agency validation

and has been published in PAM II. A

GC/MS method for glyphosate in crops

has also been validated by the Agency.

This method has not yet been submitted

for publication in PAM II.

VI. Aggregate Exposure Assessment

1. Acute dietary. There is no concern

for acute effects due to dietary exposure

to glyphosate.

2. Chronic dietary. Using the Dietary

Risk Evaluation System (DRES), a

routine chronic exposure analysis was

performed for glyphosate. The chronic

analysis for glyphosate is a worst case

estimate of dietary exposure with all

residues at tolerance levels and 100% of

the commodities assumed to be treated

with glyphosate.

3. Drinking water. In examining

aggregate exposure, FQPA directs EPA

to consider available information

concerning exposures from the pesticide

residue in food and all other nonoccupational exposures. The primary

non-food sources of exposure the

Agency looks at include drinking water

(whether from groundwater or surface

water), and exposure through pesticide

use in gardens. lawns, or buildings

(residential and other indoor uses).

The lifetime health advisory and

maximum contaminant level (MCL), for

glyphosate are the same and given as

700 parts per billion in the U.S. EPA

Office of Drinking Water‘s ‘‘Drinking

Water Health Advisory; Pesticides.’’

Environmental Fate data for glyphosate

indicate little potential for the7

chemical to migrate to ground water, but

some potential for residues to migrate to

surface waters. Glyphosate is not highly

mobile and not persistent in a soil or

water environment. Because the Agency

lacks sufficient water-related exposure

data to complete a comprehensive

drinking water risk assessment for many

pesticides, EPA has commenced and

nearly completed a process to identify a

reasonable yet conservative bounding

figure for the potential contribution of

water related exposures to the aggregate

risk posed by a pesticide. In developing

the bounding figure, EPA estimated

residue levels in water for a number of

specific pesticides using various data

sources. The Agency then applied the

estimated residue levels, in conjunction

with appropriate toxicological

endpoints (RfD‘s or acute dietary

NOEL‘s) and assumptions about body

weight and consumption, to calculate,

for each pesticide, the increment of

aggregate risk contributed by

consumption of contaminated water.

While EPA has not yet pinpointed the

appropriate bounding figure for

consumption of contaminated water, the

ranges the Agency is continuing to

examine are all below the level that

would cause glyphosate to exceed the

RfD if the tolerances being considered in

this document were granted. The

Agency has therefore concluded that the

potential exposures associated with

glyphosate in water, even the higher

levels the Agency is considering as a

conservative upper bound, would not

prevent the Agency from determining

that there is a reasonable certainty of no

harm if the tolerance is granted.

4. Non occupational (residential) and

non-dietary. Glyphosate is registered for

residential uses. As part of the hazard

assessment process, the Agency reviews

the available toxicological database to

determine the endpoints of concern. For

glyphosate, the Agency does not have a

concern for acute, short-term, or

intermediate occupational or residential

risk since the available data do not

indicate any evidence of significant

toxicity by the dermal or inhalation

routes, or from a 1 day or single event

exposure by the oral route. Therefore, an
17726 Federal Register / Vol. 62, No. 70 / Friday, April 11, 1997 / Rules and Regulations

acute, a short-term, or intermediate-term

occupational or residential risk

assessment was not required.

As part of the hazard assessment

process it was determined that a chronic

residential assessment was not

necessary. The exposures which would

result from the use of glyphosate were

determined to be of an intermittent

nature. The frequency and duration of

these exposures do not exhibit a chronic

exposure pattern. The exposures do not

occur often enough to be considered a

chronic exposure i.e., a continuous

exposure that occurs for at least several

months. Therefore, residential

exposures were not aggregated with

dietary exposures in estimating chronic

risk.

6. Cumulative exposure to substances

with common mechanism of toxicity.

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.’’

The Agency believes that ‘‘available

information’’ in this context might

include not only toxicity, chemistry,

and exposure data, but also scientific

policies and methodologies for

understanding common mechanisms of

toxicity and conducting cumulative risk

assessments. For most pesticides,

although the Agency has some

information in its files that may turn out

to be helpful in eventually determining

whether a pesticide shares a common

mechanism of toxicity with any other

substances, EPA does not at this time

have the methodologies to resolve the

complex scientific issues concerning

common mechanism of toxicity in a

meaningful way. EPA has begun a pilot

process to study this issue further

through examination of particular

classes of pesticides. The Agency hopes

that the results of this pilot process will

increase the Agency‘s scientific

understanding of this question such that

EPA will be able to develop and apply

scientific principles for better

determining which chemicals have a

common mechanism of toxicity and

evaluating the cumulative effects of

such chemicals. The Agency anticipates,

however, that even as its understanding

of the science of common mechanisms

increases, decisions on specific classes

of chemicals will be heavily dependent

on chemical specific data, much of

which may not be presently available.

Although at present the Agency does

not know how to apply the information

in its files concerning common

mechanism issues to most risk

assessments, there are pesticides as to

which the common mechanisms issues

can be resolved. These pesticides

include pesticides that are

toxicologically and structurally

dissimilar to existing chemical

substances (in which the Agency can

conclude that it is unlikely that a

pesticide shares a common mechanism

of activity with other substances) and

pesticides that produce a common toxic

metabolite (in which case common

mechanism of activity will be assumed).

EPA does not have, at this time,

available data to determine whether

glyphosate 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

common mechanism of toxicity,

glyphosate does not appear to produce

a toxic metabolite produced by other

substances. For the purposes of this

tolerance action, therefore EPA has not

assumed that glyphosate has a common

mechanism of toxicity with other

substances. A condition of the

registrations associated with these

tolerances will be that the registrant will

provide common mechanism data in a

timely manner when and if the Agency

asks for it. After EPA develops

methodologies for more fully applying

common mechanism of toxicity issues

to risk assessments, the Agency will

develop a process (either as a part of the

periodic review of pesticides or

otherwise) to reexamine those tolerance

decisions made earlier.

VII. Determination of Safety for the U.S.

Population and Nonnursing Infants

Using the Dietary Risks Evaluation

System (DRES) a chronic analysis was

based on 100% of the crop treated and

all residues at tolerance levels. Based on

the dietary risk assessment the proposed

uses utilize 0.115% of the RfD for U.S.

population; 0.189% of the RfD for nonnursing infants under 1 year old; 0.84 of

the RfD for nursing infants under 1 year

old; 0.866% of the RfD for children 1 to

6 years old; and 0.443% of the RfD for

children 7 to 12 years old. Total

aggregate exposure from glyphosate

residues in food, taking into account

existing and proposed uses, uses 1% of

the RfD for the overall U.S. population

and nursing infants: 3% of the RfD for

nonnursing infants under 1 year old and

children 1 to 6 years old; 3%; and 2%

of the RfD for children 7 to 12 years old.

An additional risk assessment for

residential uses was not required

because of no evidence of significant

toxicology via dermal or inhalation

routes. Even though the Agency has not

pinpointed the appropriate bounding

figure for consumption of contaminated

water, the ranges the Agency is

continuing to examine are all below the

level that would cause glyphosate to

exceed the RfD. EPA concluded that

there is reasonable certainty that no

harm will occur from aggregate

exposure to glyphosate.

VIII. Determination of Safety for Infants

and Children

FFCDA section 408 provides that EPA

shall apply an additional tenfold margin

of exposure (safety) for infants and

children in the case of threshold effects

to account for pre-and post-natal

toxicity and the completeness of the

database unless EPA determines that a

different margin of exposure (safety)

will be safe for infants and children.

Margins or exposure (safety) are often

referred to as uncertainty (safety)

factors. EPA believes that reliable data

support using the standard margin of

exposure (usually 100x for combined

inter- and intra-species variability) and

not the additional tenfold margin of

exposure when EPA has a complete data

base under existing guidelines and

when the severity of the effect in infants

and children or the potency or unusual

toxic properties of a compound do not

raise concerns regarding the adequacy of

the standard margin of exposure.

Risk to infants and children was

determined by the use of two

developmental toxicity studies in rats

and rabbits and the two-generation

reproduction study in rats discussed

below. The developmental toxicity

studies evaluates the potential for

adverse effects on the developing

organism resulting from exposure

during prenatal development. The

reproduction study provides

information relating to effects from

exposure to the chemical on the

reproductive capability of both (mating)

parents and on systemic toxicity.

The toxicological database for

evaluating pre- and post-natal toxicity

for glyphosate is considered to be

complete at this time. In the rabbits, no

developmental toxicity was observed at

doses where significant maternal

toxicity was noted (death and clinical

signs at 350 mg/kg/day, highest dose

tested HDT. In the rat developmental

toxicity study, maternal (systemic)

toxicity was noted at 3,500 mg/kg/day,

HDT as diarrhea, decreased mean body

weight gain, breathing rattles, inactivity,

red matter around the nose and mouth,

and on forelimbs and dorsal head,

decreases in total implantations/dam

and inviable fetuses/dam and death

(24% of the group). The developmental

(pup) NOEL is 1,000 mg/kg/day. The
Federal Register / Vol. 62, No. 70 / Friday, April 11, 1997 / Rules and Regulations 17727

developmental (pup) toxicity was

exhibited only in the high dose as

increased numbers of litters and fetuses

with unossified sternebrae, and

decreased mean fetal body weights.

However, these developmental effects

were assumed to be due to the extreme

maternal toxicity. No effects on

reproductive parameters were observed.

In the rat two-generation reproduction

study, parental toxicity was observed at

1,500 mg/kg/day as soft stools,

decreased food consumptions and body

weight gain. The developmental (pup)

toxicity was also only exhibited at 1,500

mg/kg/day as decreased body weight

gain of the F1a, F2a, and F2b male and

female pups during the second and

third weeks of lactation.

The RfD is based on the NOEL for

maternal toxicity in the rabbit

developmental study. No developmental

effects were noted in the study. In the

rat developmental study effects were

noted only at 20x higher than the NOEL

used for the RfD. No pre- or post-natal

effects were seen in any study absent

maternal toxicity. In the rat

reproduction study developmental

effects were noted at 5x the NOEL used

for the RfD. The Agency does not

believe the effects seen in these studies

are of such concern to require an

additional safety factor. Accordingly,

the Agency believes the RfD has an

adequate margin of protection for

infants and children. The percent RfD

utilized by glyphosate is from 1% for

nursing infants (less than 1 year old) to

3% for non-nursing infants and children

1 to 6 years old. EPA concluded that

there is reasonable certainty that no

harm will occur to infants and children

from aggregate exposure to glyphosate.

IX. Other Considerations

Endocrine effects. No specific tests

have been conducted with glyphosate to

determine whether the chemical may

have an effect in humans that is similar

to an effect produced by a naturally

occurring estrogen or other endocrine

effects. However, there are no

significant findings in other relative

toxicity studies, i.e., teratology and

multi-generation reproductive studies

which would suggest that glyphosate

produces these kinds of effects.

X. Data Gaps

Data desirable but lacking for these

tolerances include specific geographic

representative grain sorghum and corn

field residue trials. Because of

insufficient time since the imposition of

additional data requirements the

Agency is requiring that this data be

submitted as a condition of registration.

Based on the information cited above,

the Agency has determined that the

establishment of these tolerances by

amending 40 CFR part 180 will be safe,

therefore the tolerances are established

as set forth below.

In addition to the time-limited

tolerances being amended, since for

purposes of establishing tolerances

FQPA has eliminated all distinctions

between raw and processed food, EPA is

combining the tolerances that now

appear in §§ 185.3500 and 186.3500

with the tolerances in § 180.364 and is

eliminating §§ 185.3500 and 186.3500.

XI. Response to Comment

The one commenter raised several

concerns regarding these tolerances.

1. Increased exposure. The

commenter was concerned that approval

of these tolerances would lead to

increased exposure to glyphosate

because it would enhance Monsanto‘s

ability to market glyphosate-tolerant

corn and thus use glyphosate. The

commentor argued that therefore

approval of the tolerances would not

protect the public health rather it would

increase risk.

EPA response. Approval of these

tolerances may lead to higher exposure

the glyphosate residues. That is the case

when ever EPA approves a new

tolerance. The question before EPA in

ruling on a tolerance petition is whether

the tolerance meets the FFDCA‘s safety

standard. As detailed above, EPA has

concluded that these tolerances do meet

the reasonable certainty of no harm

standard. This standard requires

consideration of exposure to glyphosate

from existing uses as well as exposure

from the uses covered by the tolerances

in the petition before EPA.

2. Glyphosate residues in foods

derived from animals. The commenter

asked EPA to confirm that the major

route of exposure resulting from these

tolerances would be from foods derived

from animals. The commenter also

asked how the tolerances would effect

the level of glyphosate residues in

animal feeds and what percentage of

glyphosate treated corn would be

consumed by humans.

EPA response. The nature of

glyphosate residue in plants and

animals has been explored by various

studies that have been reviewed by the

Agency. A separate peer review

committee ‘‘Metabolism Committee’’

evaluated glyphosate plant and animal

commodities and decided that the major

metabolite is not of toxicological

concern regardless of its level in food.

Due to the use pattern of glyphosate,

secondary residues in animal

commodities are expected. Corn grain,

forage, fodder, and aspirated grain

fractions are animal feed items. Based

on the proposed tolerances on aspirated

grain fractions, corn stover, forage, and

grain, the dietary burden of at most 78

ppm glyphosate residue in/on corn

commodities, (if all corn commodities

(including corn genetically altered to be

tolerant to glyphosate) are fed)) will be

covered by the tolerances currently

established on meat, milk, eggs, and

livestock commodities including the

recently (April 5, 1996, 61 FR

15192)(FRL–5351–1), established

tolerances on kidney of cattle, goats,

hogs, horses, poultry, and sheep at 4

ppm. A chronic (long-term) dietary

exposure analysis (DRES) was

performed for the use of glyphosate in/

on corn. The Agency used the following

conservative (worst-case) assumptions:

all corn (including genetically altered

corn) would have the same tolerance

level residues, and that 100 percent of

the crop is treated. It is not believed that

actual residues would reach tolerance

levels, or that 100 percent of the total

corn crop would be treated with

glyphosate. The Agency feels that the

risk to human health does not exceed a

level of concern (100%) due to the

percent of the RfD using the ‘‘worst

case’’ assumptions. These dietary risk

numbers include corn consumed

directly by humans, plus meat, milk and

eggs from which animals consumed

corn raw agricultural commodities as

feed. Published and proposed

glyphosate tolerances result in the

following percents of the RfD used: 1%

for the overall U.S. population and

nursing infants, 2% for children (7 to 12

years old), and 3% non-nursing infants

less than 1 year old and children (1 to

6 years old).

3. Toxicology concerns. The

commenter challenged Monsanto’s

assertions that glyphosate was of low

toxicity. The commenter cited the fact

that glyphosate ranked number 3 in

California for acute illnesses in

agriculture from 1984–1990. The

commenter claimed that glyphosate is a

skin and eye irritant, a possible

carcinogen, a mutagen, and a

reproductive toxicant. In support of

glyphosate‘s carcinogenicity, the

commenter claimed that one of the

metabolites or breakdown products of

glyphosate is formaldehyde and the

commenter asserted that formaldehyde

is a carcinogen, mutagen, and

reproductive toxicant.

Additionally, the commenter claimed

that a study showed that glyphosate

decreased lung function and that studies

showed that glyphosate inhibits

enzymes involved in the detoxification

of chemicals.
17728 Federal Register / Vol. 62, No. 70 / Friday, April 11, 1997 / Rules and Regulations

4. Acute illnesses and skin and eye

irritation—EPA response. Data indicate

that technical-grade glyphosate is in

Toxicity Category III and Toxicity

Category IV and that technical

glyphosate is not a dermal sensitizer.

Some formulations of glyphosate are in

Category I and II where skin and eye

irritation were associated with acute

illnesses. Some of these formulations

are being phased out of the U.S. market.

Handlers and users of remaining

formulations in Category I and II are

expected to be adequately protected by

the protective clothing requirements of

the Worker Protection Standards (WPS).

Data reviewed by the Agency on current

formulations place these formulations in

Toxicity Category III and IV.

5. Carcinogen, mutagen and

reproductive toxicity—EPA response.

Data indicate that glyphosate is a group

E carcinogen (evidence of

noncarcinogenicity for studies in

humans, causes no pre- or post-natal

effects in any study absent maternal

toxicity, and is not a mutagen (refer to

toxicology discussion above for a

detailed discussion of carcinogenicity,

reproductive, developmental and

mutagenicity testing).

6. Formaldehyde—EPA response.

Available rat metabolism data, residue

data, and environmental data indicate

that the major metabolite of glyphosate

is AMPA which is further degraded by

soil microbes to CO2. The Agency has

determined that AMPA is not of

toxicological concern. (Glyphosate

Reregistration Eligibility Decision (RED)

issued by EPA September 1993).

Available data do not indicate that

formaldehyde is a metabolite or a

degradate of glyphosate.

7. Decreased lung function—EPA

response. Data reviewed by the Agency

for glyphosate formulations for acute

inhalation place most glyphosate

formulations in Toxicity Category III

and IV for acute inhalation. The Agency

believes that handlers of these

formulations and any formulations that

may be Toxicity Category I or II are

expected to be adequately protected by

the protective clothing required by

WPS.

8. Interference with enzymes—EPA

response. The mode of action for

glyphosate does involve interference

with enzymes that result in the death of

plants by inhibiting the biosynthesis of

aromatic amino acids which along with

other biochemical changes results in the

death of plants. This is a common mode

of action for various pesticides, but the

Agency has no information that

indicates that the handling or ingestion

of glyphosate in small amounts result in

interference with enzymes in the human

body.

9. Inert Ingredients. The commentor

also contended that EPA must examine

the toxicity of the inert ingredients in

glyphosate products in setting these

tolerances.

EPA response. These tolerances

establish maximum legal levels of

residues of the active ingredient

glyphosate that can be present in certain

foods. These tolerances do not legalize

any inert ingredients in glyphosate

products. If a pesticide product also

contains inert ingredients, those inert

ingredients must have tolerances or

exemptions from the requirement or

their presence in food will render the

food adulterated. Before approving a

pesticide registration under the Federal

Insecticide, Fungicide, and Rodenticide

Act, 7 U.S.C. 136 et seq., EPA checks to

make sure that all needed tolerances or

exemptions are in place. All inerts

present in current glyphosate

formulations for use on food crops

either have tolerances or exemptions

from tolerances. Additionally, under the

FIFRA registration process, EPA

evaluates the potential risks posed by

inert ingredients. The Agency requires a

full disclosure of inert ingredients for

each Roundup formulation to determine

acute toxicity such as acute eye, skin,

inhalation, and dermal sensitization.

Refer to previous discussions on skin,

eye, and acute inhalation for discussion

of formulations.

10. Persistence in soil. The

commenter claimed that glyphosate

persists in soils from 3 to 141 days.

EPA response. Data from background

field dissipation trials from eight sites

show that the median half-life (DT50)

for glyphosate applied at maximum use

rates was 13.9 days with a range of 2.6

(Texas) to 140.6 (Iowa) days. Acceptable

aerobic soil, aerobic aquatic, and

anaerobic aquatic metabolism studies

demonstrate that under those conditions

at 25 °C in the laboratory, glyphosate

degrades rapidly with half-lives of

approximately 2,7, and 8 days

respectively. The reported half-lives

from the field studies conducted in the

coldest climates, i.e. Minnesota, New

York, and Iowa, were the longest at 28.7

days, 127.8 days, and 140.6 days

respectively indicating that glyphosate

residues in the field are somewhat more

persistant in cooler climates as opposed

to milder ones (Georgia, California,

Arizona, Ohio, and Texas. AMPA was

the major degradate in all studies.

AMPA has been determined to not be of

toxicological concern. (Glyphosate

Reregistration Eligibility Decision (RED)

issued by EPA September, 1993).

11. Environmental effects. The

commenter also claimed that data was

lacking regarding glyphosate‘s toxicity

to soil invertebrates, reptiles, and

amphibians.

EPA response. Environmental Effects

are considered under FIFRA. In

examining glyphosate under FIFRA the

Agency required several tests with

mammals; acute tests to birds, fish,

aquatic invertebrates, and bees;

subacute dietary testing on birds; avian

reproduction; and chronic testing on

freshwater fish and freshwater

invertebrates. Data submitted to and

reviewed by the Agency indicate that

effects to birds, mammals, fish, and

invertebrates are minimal. (Glyphosate

Registration Eligibility Decision (RED)

issued by EPA September, 1993).

XII. Objections and Hearing Requests

The new FFDCA section 408 (g)

provides essentially the same process

for persons to ‘‘object’’ to a tolerance

regulation issued by EPA under the new

section 408 (e) and (1)(6) as was

provided in the old section 408 and

section 409. However, the period for

filing objections is 60 days rather than

30 days. EPA currently has procedural

regulations which governs the

submission of objections and hearing

requests. These regulations will require

some modification to reflect the new

law. However, until those modifications

can be made, EPA will continue to use

those procedural regulations with

appropriate adjustments to reflect the

new law.

Any person adversely affected by this

regulation may, by June 10, 1997, file

written objections to any aspect of this

regulation (including the automatic

revocation provision) and may also

request a hearing on those objections.

Objections and hearing requests must be

filed with the Hearing Clerk, at the

address given below (40 CFR 178.20). A

copy of the objections and/or hearing

requests filed with the Hearing Clerk

should be submitted to the OPP docket

for this rulemaking. The objections

submitted must specify the provisions

of the regulation deemed objectionable

and the grounds for the objections (40

CFR 178.25). Each objection must be

accompanied by the fee prescribed by

40 CFR 180.33(i). If a hearing is

requested, the objections must include a

statement of the factual issue(s) on

which the hearing is requested, the

requestor‘s contentions on each such

issue, and a summary of any evidence

relied upon by the objector (40 CFR

178.27). A request for a hearing will be

granted if the Administrator determines

that the material submitted shows the

following: There is a genuine and
Federal Register / Vol. 62, No. 70 / Friday, April 11, 1997 / Rules and Regulations 17729

substantial issue of fact; there is a

reasonable possibility that available

evidence identified by the requestor

would, if established, resolve one or

more issues in favor of the requestor,

taking into account uncontested claims

or facts to the contrary; and resolution

of the factual issue(s) in the manner

sought by the requestor would be

adequate to justify the action requested.

(40 CFR 178.32). Information submitted

in connection with an objection or

hearing request may be claimed

confidential by marking any or all of

that information as ‘‘Confidential

Business Information’’ (CBI).

Information marked as CBI will not be

disclosed except in accordance with

procedures set forth in 40 CFR part 2,

A copy of the information 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.

XIII. Public Docket

EPA has established a record for this

rulemaking under docket number [OPP–

300469; PP 8F3672, 8F3673, 5F4555,

6E4645] (including any comments and

data submitted electronically). 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 public record is located in

Room 1132 of the Public Response and

Program Resources Branch, Field

Operations Division (7506C), Office of

Pesticide Programs, Environmental

Protection Agency, Crystal Mall #2,

1921 Jefferson Davis Highway,

Arlington, VA.

Electronic comments may 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.

The official record for this

rulemaking, as well as the public

version, as described above will be kept

in paper form. Accordingly, EPA will

transfer any copies of objections and

hearing requests received electronically

into printed, paper form as they are

received and will place the paper copies

in the official rulemaking record which

will also include all comments

submitted directly in writing. The

official rulemaking record is the paper

record maintained at the address in

ADDRESSES at the beginning of this

document.

XIV. Regulatory Assessments

Requirements

Under Executive Order 12866 (58 FR

51735, October 4, 1993), this action is

not a ‘‘significant regulatory action’’

and, since this action does not impose

any information collection requirements

subject to approval under the Paperwork

Reduction Act, 44 U.S.C. 3501 et seq.,

it is not subject to review by the Office

of Management and Budget. In addition,

this action does not impose any

enforceable duty, or contain any

‘‘unfunded mandates’’ as described in

Title II of the Unfunded Mandates

Reform Act of 1995 (Pub. L. 104–4), or

require prior consultation as specified

by Executive Order 12875 (58 FR 58093,

October 28, 1993), or special

consideration as required by Executive

Order 12898 (59 FR 7629, February 16,

1994).

Because tolerances established on the

basis of a petition under section 408(d)

of FFDCA do not require issuance of a

proposed rule, the regulatory flexibility

analysis requirements of the Regulatory

Flexibility Act (RFA), 5 U.S.C. 604(a),

do not apply. Prior to the recent

amendment of the FFDCA, EPA had

treated such rulemakings as subject to

the RFA; however, the amendments to

the FFDCA clarify that no proposal is

required for such rulemakings and

hence that RFA is inapplicable.

Nonetheless, the Agency has previously

assessed whether establishing tolerances

or exemptions from tolerance, raising

tolerance levels, or expanding

exemptions adversely impact small

entities and concluded, as a generic

matter, that there is no adverse impact.

(46 FR 24950, May 4, 1981).

Pursuant to 5 U.S.C. 801 (a)(1)(A),

EPA submitted a report containing this

rule and other required information to

the U.S. Senate, the U.S. House of

Representatives and the Comptroller

General of the General Accounting

Office prior to publication of this rule in

today‘s Federal Register. This rule is

not a major rule as defined by 5 U.S.C.

804(2).

List of Subjects

40 CFR Part 180

Environmental protection,

Administrative practice and procedure,

Agriculatural commodities, Pesticides

and pest, Reporting and recordkeeping

requirements.

40 CFR Part 185

Environmental protection, Food

additives, Pesticides and pests.

40 CFR Part 186

Environmental protection, Animal

feeds, Pesticides and pests.

Dated: March 28, 1997.

Peter Caulkins,

Acting Director, Registration Division, Office

of Pesticide Programs.

Therefore, chapter I of title 40 of the

Code of Federal Regulations is amended

as follows:

PART 180—[AMENDED]

1. In part 180:

a. The authority citation for part 180

continues to read as follows:

Authority: 21 U.S.C. 346a and 371.

b. Section 180.364 is amended as

follows:

i. By adding a paragraph heading to

paragraph (a), and in the table by

revising the entry ‘‘Grain crops (except

wheat)’’ and alphabetically adding the

commodities: aspirated grain fractions;

corn, field, forage; corn, field, grain;

corn, field, stover; oats; sorghum, grain;

and sorghum, grain, stover.

ii. In paragraph (b) by transferring the

entries in the table and alphabetically

adding them to the table in paragraph

(a), by removing the remaining text of

paragraph (b), by adding a paragraph

heading and reserving paragraph (b).

iii. In paragraph (d) by transferring the

entries in the table and alphabetically

adding them to the table in paragraph

(a), by removing the remaining text of

paragraph (d).

iv. In paragraph (c) is amended by

adding a paragraph heading, ‘‘Indirect

and inadvertent residues’’, and

redesignating the amended paragraph

(c) as new paragraph (d), and by adding

a heading and reserving new paragraph

(c).

§ 180.364 Glyphosate, tolerances for

residues.

(a) General. * * *

Commodity

Parts Per

Million

(ppm)

* * * * *

Aspirated grain fractions ........... 200.0

* * * * *

Corn, field, forage ..................... 1.0

Corn, field, grain ....................... 1.0

Corn, field, stover ..................... 100.0

* * * * *

Grain crops (except wheat,

corn, oats, and grain sorghum) .................................... 0.010

* * * * *

Oats, grain ................................ 20.0

* * * * *

Sorghum, grain ......................... 15.0

Sorghum, grain, stover ............. 40.0
17730 Federal Register / Vol. 62, No. 70 / Friday, April 11, 1997 / Rules and Regulations

Commodity

Parts Per

Million

(ppm)

* * * * *

(b) Section 18 emergency exemptions.

[Reserved]

(c) Tolerances with regional

registrations. [Reserved]

(d) Indirect or inadvertent

residues. * * *

PART 185—[AMENDED]

2. In part 185:

a. The authority citation for part 185

continues to read.

Authority: 21 U.S.C. 346a and 348.

§ 185.3500 [Removed]

b. In § 185.3500 by transferring the

entries in the tables to paragraphs (a)(1),

(2), and (3), and alphabetically adding

them to the table in paragraph (a) of

§ 180.364, and by removing the

remainder of § 185.3500.

PART 186—[AMENDED]

3. In part 186:

a. The authority citation for part 185

continues to read.

Authority: 21 U.S.C. 342, 348 and 701.

§ 186.3500 [Removed]

b. In § 186.3500 by transferring the

entries in the tables to paragraphs (a)

and (b) and alphabetically adding them

to the table in paragraph (a) of

§ 180.364, and by removing the

remainder of § 186.3500.

[FR Doc. 97–9231 Filed 4–10–97; 8:45 am]

BILLING CODE 6560–50–F

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Parts 180, 185 and 186

[OPP–300466; FRL–5597–9]

RIN 2070–AC78

Myclobutanil; Pesticide Tolerances for

Emergency Exemptions

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Final rule.

SUMMARY: This regulation establishes a

time-limited tolerance for residues of

the fungicide myclobutanil in or on the

raw agricultural commodity

strawberries in connection with EPA’s

granting of an emergency exemption

under section 18 of the Federal

Insecticide, Fungicide, and Rodenticide

Act authorizing use of myclobutanil on

strawberries in Florida. This regulation

establishes a maximum permissible

level for residues of myclobutanil in this

food pursuant to section 408(l)(6) of the

Federal Food, Drug and Cosmetic Act,

as amended by the Food Quality

Protection Act of 1996. The tolerance

will expire and be revoked by EPA on

March 31, 1998.

DATES: This regulation becomes

effective April 11, 1997. Objections and

requests for hearings must be received

by EPA on June 10, 1997.

ADDRESSES: Written objections and

hearing requests, identified by the

docket control number, [OPP ], must be

submitted to: Hearing Clerk (1900),

Environmental Protection Agency, Rm.

M3708, 401 M St., SW., Washington, DC

20460. Fees accompanying objections

and hearing requests shall be labeled

‘‘Tolerance Petition Fees’’ and

forwarded to: EPA Headquarters

Accounting Operations Branch, OPP

(Tolerance Fees), P.O. Box 360277M,

Pittsburgh, PA 15251. A copy of any

objections and hearing requests filed

with the Hearing Clerk identified by the

document control number, [OPP ],

should be submitted to: Public Response

and Program Resources Branch, Field

Operations Division (7506C), Office of

Pesticide Programs, Environmental

Protection Agency, 401 M St., SW.,

Washington, DC 20460. In person, bring

a copy of objections and hearing

requests to Rm. 1132, CM #2, 1921

Jefferson Davis Hwy., Arlington, VA.

A copy of objections and hearing

requests filed with the Hearing Clerk

may also be submitted electronically by

sending electronic mail (e-mail) to: oppdocket@epamail.epa.gov. Copies of

objections and hearing requests must be

submitted as an ASCII file avoiding the

use of special characters and any form

of encryption. Copies of objections and

hearing requests will also be accepted

on disks in WordPerfect 5.1 file format

or ASCII file format. All copies of

objections and hearing requests in

electronic form must be identified by

the docket number [OPP ]. No

Confidential Business Information (CBI)

should be submitted through e-mail.

Electronic copies of objections and

hearing requests on this rule may be

filed online at many Federal Depository

Libraries.

FOR FURTHER INFORMATION CONTACT: By

mail: Stephen Schaible, Registration

Division (7505W), Environmental

Protection Agency, 401 M St., SW.,

Washington, DC 20460. Office location,

telephone number, and e-mail address:

Sixth Floor, Crystal Station #1, 2800

Jefferson Davis Highway, Arlington, VA

22202. (703) 308–8337, e-mail:

schaible.stephen@epamail.epa.gov.

SUPPLEMENTARY INFORMATION: EPA,

pursuant to section 408(e) and (l)(6) of

the Federal Food, Drug, and Cosmetic

Act (FFDCA), 21 U.S.C. 346a(e) and

(l)(6), is establishing a tolerance for

residues of the fungicide myclobutanil

[alpha-butyl-alpha-(4-chlorophenyl)-1H1,2,4-triazole-1-propanenitrile] and its

metabolite alpha-(3-hydroxybutyl)-

alpha-(4-chlorophenol)-1H-1,2,4-

triazole-1-propanenitrile (free and

bound), hereafter referred to as

myclobutanil, in or on strawberries at

0.5 part per million (ppm). This

tolerance will expire and be revoked on

March 31, 1998.

I. Background and Statutory Authority

The Food Quality Protection Act of

1996 (FQPA) (Pub. L. 104–170) was

signed into law August 3, 1996. FQPA

amends both the Federal Food, Drug,

and Cosmetic Act (FFDCA), 21 U.S.C.

301 et seq., and the Federal Insecticide,

Fungicide, and Rodenticide Act

(FIFRA), 7 U.S.C. 136 et seq. The FQPA

amendments went into effect

immediately. Among other things,

FQPA amends FFDCA to bring all EPA

pesticide tolerance-setting activities

under a new section 408 with a new

safety standard and new procedures.

These activities are described below and

discussed in greater detail in the final

rule establishing the time-limited

tolerance associated with the emergency

exemption for use of propiconazole on

sorghum (61 CFR 58135, November 13,

1996)(FRL–5572–9).

New section 408(b)(2)(A)(i) allows

EPA to establish a tolerance (the legal

limit for a pesticide chemical residue in

or on a food) only if EPA determines

that the tolerance is ‘‘safe.’’ Section

408(b)(2)(A)(ii) defines ‘‘safe’’ to mean

that ‘‘there is a reasonable certainty that

no harm will result from aggregate

exposure to the pesticide chemical

residue, including all anticipated

dietary exposures and all other

exposures for which there is reliable

information.’’ This includes exposure

through drinking water, but does not

include occupational exposure. Section

408(b)(2)(C) requires EPA to give special

consideration to exposure of infants and

children to the pesticide chemical

residue in establishing a tolerance and

to ‘‘ensure that there is a reasonable

certainty that no harm will result to

infants and children from aggregate

exposure to the pesticide chemical

residue....’’

Section 18 of FIFRA authorizes EPA

to exempt any Federal or State agency

from any provision of FIFRA, if EPA

determines that ‘‘emergency conditions