17710 Federal Register / Vol. 62, No. 70 / Friday, April 11, 1997 / Rules and Regulations

45. Section 21.344 is amended by

revising the authority citation to read as

follows:

§ 21.344 Facility offering training or

rehabilitation services.

* * * * *

(Authority: 38 U.S.C. 3110)

46. Section 21.390 is amended by

revising paragraph (c) to read as follows:

§ 21.390 Rehabilitation research and

special projects.

* * * * *

(c) Research by Vocational

Rehabilitation and Counseling (VR&C)

staff members. VA will encourage

research by VR&C staff members. This

research will address problems affecting

service delivery, initiation and

continuation in rehabilitation programs,

and other areas directly affecting the

quality of VR&C services to veterans.

(Authority: 38 U.S.C. 3119(a))

* * * * *

47. Section 21.410 is revised to read

as follows:

§ 21.410 Delegation of authority.

The Secretary delegates authority to

the Under Secretary for Benefits to make

findings and decisions under 38 U.S.C.

chapter 31 and regulations, precedents,

and instructions that affect vocational

rehabilitation services for disabled

veterans. The Under Secretary for

Benefits may further delegate this

authority to supervisory and nonsupervisory Vocational Rehabilitation

and Counseling staff members.

(Authority: 38 U.S.C. 512(a))

48. In § 21.430, paragraph (c) is

amended by revising the heading and

introductory text; and the authority

citation is revised to read as follows:

§ 21.430 Accountability for authorization

and payment of training and rehabilitation

services.

* * * * *

(c) Vocational Rehabilitation and

Counseling (VR&C) Officer’s review of

program costs. The VR&C Officer will

review the program costs for the

services in paragraphs (c)(1) through

(c)(3) of this section if the case

manager’s program cost estimate for a

calendar year exceeds $25,000. The

VR&C Officer may not delegate this

responsibility. The case manager will

neither sign a rehabilitation plan nor

authorize expenditures before the VR&C

Officer approves the program costs. The

services subject to this review are:

* * * * *

(Authority: 38 U.S.C. 3115(b)(4))

[FR Doc. 97–9022 Filed 4–10–97; 8:45 am]

BILLING CODE 8320–01–P

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Part 180

[OPP–300474; FRL–5600–5]

RIN 2070–AB78

Propiconazole; Pesticide Tolerances

for Emergency Exemptions

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Final rule.

SUMMARY: This regulation establishes

time-limited tolerances for combined

residues of the pesticide propiconazole

in or on the raw agricultural

commodities almonds and cranberries

in connection with EPA’s granting of

emergency exemptions under section 18

of the Federal Insecticide, Fungicide,

and Rodenticide Act authorizing use of

propiconazole on almonds in California

and cranberries in Wisconsin. This

regulation establishes maximum

permissible levels for residues of

propiconazole in these foods pursuant

to section 408(l)(6) of the Federal Food,

Drug and Cosmetic Act, as amended by

the Food Quality Protection Act of 1996.

DATES: This regulation becomes

effective April 11, 1997. Objections and

requests for hearings must be received

by EPA on or before June 10, 1997.

ADDRESSES: Written objections and

hearing requests, identified by the

docket control number, [OPP–300474],

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 docket control number, [OPP–

300474], must also 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. Such 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 control number [OPP–

300474]. 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: Olga Odiott, Registration Division

(7505W), Environmental Protection

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

DC 20460. Office location, telephone

number, and e-mail: Sixth Floor, Crystal

Station #1, 2800 Jefferson Davis

Highway, Arlington, VA 22202. (703)

308-6418, e-mail:

odiott.olga@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 tolerances for

residues of the pesticide propiconazole

(1-[[2-(2,4-dichlorophenyl)-4-propyl-1,3-

dioxolan-2-yl]methyl]-1H-1,2,4-triazole)

in or on almond nutmeats at 0.1 part per

million (ppm), in or on almond hulls at

2.5 ppm, and in or on cranberries at 1.0

ppm.

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 FR 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
Federal Register / Vol. 62, No. 70 / Friday, April 11, 1997 / Rules and Regulations 17711

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

exist which require such exemption.’’

This provision was not amended by

FQPA. EPA has established regulations

governing such emergency exemptions

in 40 CFR part 166.

Section 408(l)(6) requires EPA to

establish a time-limited tolerance or

exemption from the requirement for a

tolerance for pesticide chemical

residues in food that will result from the

use of a pesticide under an emergency

exemption granted by EPA under

section 18 of FIFRA. Section 408(l)(6)

also requires EPA to promulgate

regulations by August 3, 1997,

governing the establishment of

tolerances and exemptions under

section 408(l)(6) and requires that the

regulations be consistent with section

408(b)(2) and (c)(2) and FIFRA section

18.

Section 408(l)(6) allows EPA to

establish tolerances or exemptions from

the requirement for a tolerance, in

connection with EPA’s granting of

FIFRA section 18 emergency

exemptions, without providing notice or

a period for public comment. Thus,

consistent with the need to act

expeditiously on requests for emergency

exemptions under FIFRA, EPA can

establish such tolerances or exemptions

under the authority of section 408(e)

and (l)(6) without notice and comment

rulemaking.

In establishing section 18-related

tolerances and exemptions during this

interim period before EPA issues the

section 408(l)(6) procedural regulation

and before EPA makes its broad policy

decisions concerning the interpretation

and implementation of the new section

408, EPA does not intend to set

precedents for the application of section

408 and the new safety standard to other

tolerances and exemptions. Rather,

these early section 18 tolerance and

exemption decisions will be made on a

case-by-case basis and will not bind

EPA as it proceeds with further

rulemaking and policy development.

EPA intends to act on section 18-related

tolerances and exemptions that clearly

qualify under the new law.

II. Emergency Exemptions for

Propiconazole on Almonds and on

Cranberries and FFDCA Tolerances

The California EPA Department of

Pesticide Regulation availed itself of the

authority to declare the existence of a

crisis situation within the state on

February 3, 1997, thereby authorizing

use under FIFRA Section 18 of

propiconazole on almonds to control

anthracnose (Colletotrichum acutatum).

California has also requested a specific

exemption for this use of propiconazole.

California stated that an emergency

situation was present due to persistent

and extended periods of rainfall during

1991 to 1995, which caused anthracnose

levels to reach epidemic proportions in

the northern and central almond

growing areas of the state. California

also stated that the causal organism is

relatively insensitive to registered

pesticides and that significant

production and revenue losses are

expected to occur without the

availability of propiconazole. After

having reviewed their submission, EPA

concurs that an emergency condition

exists.

The Wisconsin Department of

Agriculture, Trade and Consumer

Protection have requested a specific

exemption for the use of propiconazole

on cranberries to control cottonball

disease. Production and distribution of

triforine (Funginex), the only fungicide

registered for control of cottonball

disease, has been discontinued by its

manufacturer. Most growers depleted

their supplies of Funginex during the

1996 growing season. Wisconsin states

that the lack of a fungicide to control

cottonball disease can have devastating

effects on cranberry growers’ production

and revenue. After having reviewed

their submission, EPA concurs that an

emergency condition exists.

As part of its assessment, EPA

assessed the potential risks presented by

residues of propiconazole in or on

almonds nutmeats, in or on almond

hulls, and in or on cranberries. In doing

so, EPA considered the new safety

standard in FFDCA section 408(b)(2),

and EPA decided to grant the section 18

exemptions only after concluding that

the necessary tolerances under FFDCA

section 408(l)(6) would clearly be

consistent with the new safety standard

and with FIFRA section 18. These

tolerances for propiconazole will permit

the marketing of almonds and

cranberries treated in accordance with

the provisions of the section 18

emergency exemptions. Consistent with

the need to move quickly on the

emergency exemptions and to ensure

that the resulting food is safe and

lawful, EPA is issuing these tolerances

without notice and opportunity for

public comment under section 408(e) as

provided for in section 408(l)(6).

Although these tolerances will expire as

intended in the table, under FFDCA

section 408(l)(5), residues of

propiconazole not in excess of the

amount specified in the tolerances

remaining in or on almonds after that

date will not be unlawful, provided the

pesticide is applied during the term of,

and in accordance with all the

conditions of, the emergency

exemption. EPA will take action to

revoke these tolerances earlier if any

experience with, scientific data on, or

other relevant information on this

pesticide indicate that the residues are

not safe.

EPA has not made any decisions

about whether propiconazole meets the

requirements for registration under

FIFRA section 3 for use on almonds and

cranberries, or whether permanent

tolerances for propiconazole for these

commodities would be appropriate.

This action by EPA does not serve as a

basis for registration of propiconazole

by a State for special local needs under

FIFRA section 24(c). Nor does this

action serve as the basis for any State

other than California and Wisconsin to

use this product on these crops under

section 18 of FIFRA without following

all provisions of section 18 as identified

in 40 CFR part 166. For additional

information regarding the emergency

exemptions for propiconazole, contact

the Agency’s Registration Division at the

address provided above.

III. Risk Assessment and Statutory

Findings

EPA performs a number of analyses to

determine the risks from aggregate

exposure to pesticide residues. First,

EPA determines the toxicity of

pesticides based primarily on

toxicological studies using laboratory

animals. These studies address many

adverse health effects, including (but

not limited to) reproductive effects,

developmental toxicity, toxicity to the

nervous system, and carcinogenicity.

For many of these studies, a doseresponse relationship can be

determined, which provides a dose that

causes adverse effects (threshold effects)

and doses causing no observed effects

(the ‘‘no-observed effect level’’ or

‘‘NOEL’’).

Once a study has been evaluated and

the observed effects have been

determined to be threshold effects, EPA

generally divides the NOEL from the

study with the lowest NOEL by an
17712 Federal Register / Vol. 62, No. 70 / Friday, April 11, 1997 / Rules and Regulations

uncertainty factor (usually 100 or more)

to determine the Reference Dose (RfD).

The RfD is a level at or below which

daily aggregate exposure over a lifetime

will not pose appreciable risks to

human health. An uncertainty factor

(sometimes called a ‘‘safety factor’’) of

100 is commonly used since it is

assumed that people may be up to 10

times more sensitive to pesticides than

the test animals, and that one person or

subgroup of the population (such as

infants and children) could be up to 10

times more sensitive to a pesticide than

another. In addition, EPA assesses the

potential risks to infants and children

based on the weight of the evidence of

the toxicology studies and determines

whether an additional uncertainty factor

is warranted. Thus, an aggregate daily

exposure to a pesticide residue at or

below the RfD (expressed as 100% or

less of the RfD) is generally considered

by EPA to pose a reasonable certainty of

no harm.

Lifetime feeding studies in two

species of laboratory animals are

conducted to screen pesticides for

cancer effects. When evidence of

increased cancer is noted in these

studies, the Agency conducts a weightof-the-evidence review of all relevant

toxicological data including short-term

and mutagenicity studies and structureactivity relationships. Once a pesticide

has been classified as a potential human

carcinogen, different types of risk

assessments (e.g., linear low-dose

extrapolations or margin of exposure

calculation based on the appropriate

NOEL) will be carried out based on the

nature of the carcinogenic response and

the Agency’s knowledge of its mode of

action.

In examining aggregate exposure,

FFDCA section 408 requires that EPA

take into account available and reliable

information concerning exposure from

the pesticide residue in the food in

question, residues in other foods for

which there are tolerances, and other

non-occupational exposures, such as

where residues leach into groundwater

or surface water that is consumed as

drinking water. Dietary exposure to

residues of a pesticide in a food

commodity are estimated by

multiplying the average daily

consumption of the food forms of that

commodity by the tolerance level or the

anticipated pesticide residue level. The

Theoretical Maximum Residue

Contribution (TMRC) is an estimate of

the level of residues consumed daily if

each food item contained pesticide

residues equal to the tolerance. The

TMRC is a ‘‘worst case’’ estimate since

it is based on the assumptions that food

contains pesticide residues at the

tolerance level and that 100% of the

crop is treated by pesticides that have

established tolerances. If the TMRC

exceeds the RfD or poses a lifetime

cancer risk that is greater than

approximately one in a million, EPA

attempts to derive a more accurate

exposure estimate for the pesticide by

evaluating additional types of

information (anticipated residue data

and/or percent of crop treated data)

which show, generally, that pesticide

residues in most foods when they are

eaten are well below established

tolerances.

IV. Aggregate Risk Assessments,

Cumulative Risk Discussion, and

Determination of Safety

Consistent with section 408(b)(2)(D),

EPA has reviewed the available

scientific data and other relevant

information in support of this action.

Propiconazole is registered by EPA for

use on pecans for control of scab, and

on stone fruits for control of brown rot.

At this time EPA is not in possession of

a registration application for

propiconazole on almonds or on

cranberries. However, based on

information submitted to the Agency,

EPA has sufficient data to assess the

hazards of propiconazole and to make a

determination on aggregate exposure,

consistent with section 408(b)(2), for the

time-limited tolerances for residues of

propiconazole in or on almond

nutmeats at 0.1 part per million (ppm),

in or on almond hulls at 2.5 ppm, and

in or on cranberries at 1.0 ppm. EPA’s

assessment of the dietary exposures and

risks associated with establishing these

tolerances follows.

A. Toxicological Profile

1. Chronic toxicity. Based on the

available chronic toxicity data, the

Office of Pesticide Programs (OPP) has

established the RfD for propiconazole at

0.013 mg/kg/day. The RfD is based on

a one-year feeding study in dogs with a

NOEL of 1.25 mg/kg/day and an

uncertainty factor (UF) of 100. The

lowest effect level (LEL) of 6.25 mg/kg/

day was based on mild irritation of the

gastric mucosa.

2. Acute toxicity. Based on the

available acute toxicity data, OPP has

determined that the NOEL of 30 mg/kg/

day from a developmental toxicity study

in rats should be used to assess risks

from acute toxicity. The developmental

LEL of 90 mg/kg/day was based on the

increased incidence of unossified

sternebrae, rudimentary ribs, and

shortened or absent renal papillae. This

risk assessment evaluates acute dietary

risk to females 13+ years.

3. Short- and intermediate-term

toxicity. Based on the available data,

OPP has determined that a NOEL of 30

mg/kg/day from a developmental

toxicity study in rats should be used to

assess risks from short- and

intermediate-term dermal toxicity. At

the developmental LEL of 90 mg/kg/day,

there were increased incidences of

unossified sternebrae, rudimentary ribs,

and shortened or absent renal papillae.

For short- and intermediate-term

inhalation toxicity, OPP has determined

that a NOEL of 92.8 mg/kg/day (0.5 mg/

L), the highest dose tested from a 5-day

inhalation toxicity study in rats should

be used to assess risks for occupational

and residential exposure scenarios.

4. Carcinogenicity. Using its

Guidelines for Carcinogen Risk

Assessment published September 24,

1986 (51 FR 33992), EPA has classified

propiconazole as a Group C, ‘‘possible

human carcinogen’’, chemical. The OPP

Carcinogenicity Peer Review Committee

(CPRC) recommended using the RfD

approach for quantification of human

risk.

B. Aggregate Exposure

In examining aggregate exposure,

FQPA directs EPA to consider available

information concerning exposures from

the pesticide residue in food and all

other non-occupational 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).

Tolerances have been established (40

CFR 180.434) for the combined residues

of propiconazole (1-[[2-(2,4-

dichlorophenyl)-4-propyl-1,3-dioxolan2-yl]methyl]-1H-1,2,4-trizole) and its

metabolites determined as 2,4-

dichlorobenzoic acid (DCBA) and

expressed as parent compound, in or on

certain raw agricultural commodities

ranging from 0.05 ppm in milk to 60

ppm in grass (seed screenings). For

purposes of these Section 18 uses, the

nature of the residue in plants and

animals is adequately understood.

Almond hulls (proposed tolerance, 2.5

ppm) is not fed to poultry or swine, but

can be fed up to 10% of the diet of beef

and dairy cattle. This is a negligible

contribution, comparatively speaking,

and is not expected to increase the daily

dietary burden to livestock. Secondary

residues in animal commodities are not

expected to exceed existing tolerances

as a result of these Section 18 uses.

1. Chronic exposure. Given the

emergency nature of these requests for

the use of propiconazole and the
Federal Register / Vol. 62, No. 70 / Friday, April 11, 1997 / Rules and Regulations 17713

resulting need for a timely analysis and

risk assessment, the chronic dietary

(food only) risk assessment was partially

refined using anticipated residue levels

and percent crop-treated values for

selected commodities. Further

refinement using anticipated residue

levels and percent crop-treated values

for all commodities would result in

lower dietary exposure estimates.

Based on available studies used in

EPA’s assessment of environmental risk,

propiconazole is soluble in water but

relatively immobile in most soils and

fairly persistent in the environment. No

Maximum Concentration Level has been

established for residues of

propiconazole in drinking water. No

Health Advisory Levels for

propiconazole in drinking water have

been established.

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

exposure 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 propiconazole 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 propiconazole in water,

even at 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

tolerances are granted.

Propiconazole is registered for

residential usage as a preservative for

finished wood (fences, window

moldings) and for ornamental turf/

lawns. Lawn care usage data available to

the Agency indicates that there is no

reported usage of propiconazole

products by homeowners. Two sources

reported usage by lawn care operators

and landscapers. Based on acres treated

information, between 3,850 to 6,725

households are estimated to be

potentially treated with propiconazole.

This represents between 0.004% to

0.007% of all households nationally.

Based on the nature of the outdoor

and indoor residential uses of

propiconazole, OPP has concluded that

a chronic residential exposure scenario

does not exist for outdoor residential

use. A chronic residential exposure

scenario may exist for indoor residential

use. The indoor residential use (window

moldings) will be assumed to account

for 5% of the total aggregate chronic risk

until additional data are provided. This

value is considered conservative and

protective of the public health. The

aggregate chronic risk is equal to the

sum of the chronic risk from food +

water + residential (indoor and outdoor)

uses. In the best scientific judgment of

OPP, this aggregate chronic risk for

propiconazole does not exceed our level

of concern.

2. Acute exposure. The acute dietary

(food only) risk assessment used

tolerance level residues and 100% croptreated information. Thus, the acute

dietary risk estimate is an over-estimate

of exposure and it is considered to be

protective of any acute exposure

scenario.

In the best scientific judgment of OPP,

the aggregate acute risk (food and water)

from the currently registered, and this

proposed Section 18 uses of

propiconazole, do not exceed our level

of concern. While EPA has not yet

pinpointed the appropriate bounding

figure for consumption of contaminated

water, the potential exposures

associated with propiconazole in water,

even at 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 from

acute aggregate exposure.

3. Short- and intermediate-term

aggregate risk assessment. Short- and

intermediate-term aggregate risk

estimates take into account exposure

from chronic dietary food and water

(considered to be a background

exposure level) plus potential indoor

and outdoor residential exposures.

Considering the nature of the outdoor

residential uses, OPP has concluded

that a short- to intermediate-term

outdoor residential exposure scenario

could exist. The contribution from

indoor residential inhalation exposure

resulting from propiconazole-treated

window moldings to the short- and

intermediate-term aggregate risk would

be negligible, and has not been included

in this risk characterization. The

chronic food and water exposure

estimates for the aggregate short- and

intermediate-term risk assessments are

considered conservative for the reasons

mentioned above.

In the absence of data, and until

further data are provided, risks from

residential uses will be assumed to

account for 10% (5% each for outdoor

and indoor residential usage) of the total

allowable aggregate short- and

intermediate-term risk. OPP considers

this estimate of total aggregate shortand intermediate-term exposure as

conservative and protective of the

public health. In the best scientific

judgment of OPP, the shortand

intermediate-term aggregate risks from

the currently registered, and the

proposed Section 18 uses of

propiconazole, do not exceed our level

of concern.

4. Cancer risk. Based on the OPP

Carcinogenicity Peer Review

Committee’s (CPRC) recommendation

that the RfD approach be used to assess

cancer risk, a quantitative cancer risk

assessment was not performed. Human

health risk concerns due to long-term

exposure to propiconazole residues are

adequately addressed by the aggregate

chronic exposure analysis using the

RfD.

C. 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 the 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
17714 Federal Register / Vol. 62, No. 70 / Friday, April 11, 1997 / Rules and Regulations

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 mechanism issues

can be resolved. These pesticides

include pesticides that are

toxicologically dissimilar to existing

chemical substances (in which case 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

propiconazole has a common

mechanism of toxicity with other

substances or how to include this

pesticide in a cumulative risk

assessment. Unlike other pesticides for

which EPA has followed a cumulative

risk approach based on a common

mechanism of toxicity, propiconazole

does not appear to produce a toxic

metabolite produced by other

substances. For the purposes of this

tolerance action EPA has not assumed

that propiconazole has a common

mechanism of toxicity with other

substances.

D. Determination of Safety for U.S.

Population

1. Chronic risk. Using the

conservative exposure assumptions

described above, taking into account the

completeness and reliability of the

toxicity data, EPA has concluded that

dietary exposure to propiconazole will

utilize 6% of the RfD for the U.S.

population. EPA generally has no

concern for exposures below 100% of

the RfD because the RfD represents the

level at or below which daily aggregate

dietary exposure over a lifetime will not

pose appreciable risks to human health.

Despite the potential for exposure to

propiconazole from drinking water and

indoor uses, EPA does not expect the

aggregate exposure to exceed 100% of

the RfD. EPA concludes that there is a

reasonable certainty that no harm will

result from aggregate exposure to

propiconazole residues.

2. Acute risk. For the population

subgroup of concern, females 13+ years

(accounts for both maternal and fetal

exposure), the calculated Margins of

Exposure (MOE) value is 3,000. This

MOE value does not exceed the

Agency’s level of concern for acute

dietary exposure. Despite the potential

for exposure to propiconazole from

drinking water EPA concludes that the

aggregate acute risk from the currently

registered uses of propiconazole does

not exceed the Agency’s level of

concern.

3. Short- and intermediate-term risk.

For propiconazole, EPA does not have

concerns for short- and intermediateterm dietary exposure because of the

very high values calculated for the

MOE. The calculated MOE value is

37,000 for the U.S. population. Despite

the potential for exposure to

propiconazole from drinking water EPA

concludes that there is a reasonable

certainty that no harm will result from

aggregate exposure to propiconazole

residues.

E. Determination of Safety for Infants

and Children

In assessing the potential for

additional sensitivity of infants and

children to residues of propiconazole,

EPA considered data from

developmental toxicity studies in the rat

and rabbit, and a two-generation

reproduction study in the rat. The

developmental toxicity studies are

designed to evaluate adverse effects on

the developing organism resulting from

pesticide exposure during prenatal

development to one or both parents.

Reproduction studies provide

information relating to effects from

exposure to the pesticide on the

reproductive capability of mating

animals and data on systemic toxicity.

The developmental toxicity NOELs

were 30 mg/kg/day in rats and 400 mg/

kg/day (HDT) in rabbits. Developmental

toxicity was observed in rats at 90 mg/

kg/day; these effects occurred in the

presence of maternal toxicity. In rabbits,

no developmental delays or alterations

were noted; however, increased

abortions were observed at the

maternally toxic dose of 400 mg/kg/day.

The developmental NOELs are more

than 24- and 320-fold higher in rats and

rabbits, respectively, than the NOEL of

1.25 mg/kg/day from the 1-year feeding

study in dogs, which is the basis of the

RfD. In the two-generation reproductive

toxicity study in rats, the reproductive

(pup) toxicity NOEL of 25 mg/kg/day

was greater than the parental (systemic)

toxicity NOEL (<5 mg/kg/day; LDT).

The NOEL of 25 mg/kg/day for

reproductive (pup) toxicity was 20-fold

higher than the NOEL of 1.25 mg/kg/day

from the 1-year feeding study in dogs,

which is the basis of the RfD. The

reproductive (pup) LEL of 125 mg/kg/

day was based on decreased offspring

survival of second generation (F2) pups,

and on decreased body weight

throughout lactation, and an increase in

the incidence of hepatic cellular

swelling for both generations of

offspring (F1 and F2 pups). Because

these reproductive effects occurred in

the presence of parental (systemic)

toxicity, these data do not suggest

increased pre- or post-natal sensitivity

to infants and children (that infants and

children might be more sensitive than

adults) to propiconazole exposure.

1. Chronic risk. Using the

conservative exposure assumptions

described above, EPA has concluded

that the percent of the RfD that will be

utilized by exposure to residues of

propiconazole ranges from 8% for

children 7 - 12 years old, up to 20% for

non-nursing infants (the most highly

exposed population subgroup). Despite

the potential for exposure to

propiconazole from drinking water and

indoor uses, EPA does not expect the

aggregate exposure to exceed 100% of

the RfD. Therefore, taking into account

the completeness and reliability of the

toxicity data and the conservative

exposure assessment, EPA concludes

that there is a reasonable certainty that

no harm will result to infants and

children from aggregate exposure to

propiconazole residues.

2. Acute risk. For the population

subgroup of concern, females 13+ years,

an MOE value of 3,000 was calculated

using the high end exposure value of

0.01 mg/kg/day. Tolerance level

residues and 100% crop-treated

information were used in conducting

the analysis. Thus, this acute dietary

risk estimate is considered conservative.

The large acute dietary MOE calculated

for females 13+ years old provides

assurance that there is a reasonable

certainty of no harm from aggregate

exposures to females 13+ years and the

pre-natal development of infants.

3. Short- and intermediate-term risk.

For the most highly exposed population

subgroup (non-nursing infants less than

1 year old), a short- and intermediateterm MOE of 12,000 was calculated. The

large MOE calculated for non- nursing

infants provides assurance that there is

a reasonable certainty of no harm for

infants and children from short- and

intermediate-term aggregate exposures

to propiconazole residues.

FFDCA section 408 provides that EPA

shall apply an additional tenfold margin

of exposure (safety) for infants and

children in the case of threshold effects
Federal Register / Vol. 62, No. 70 / Friday, April 11, 1997 / Rules and Regulations 17715

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 of 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

or children or the potency or unusual

toxic properties of a compound do not

raise concerns regarding the adequacy of

the standard margin of exposure. Based

on current toxicological data

requirements, the database for

propiconazole relative to pre- (provided

by rat and rabbit developmental studies)

and post-natal (provided by the rat

reproduction study) toxicity is

complete.

Further, as noted above, the acute

dietary MOE for children 13+ years is

3,000. This large MOE demonstrates that

the prenatal exposure to infants is not

a toxicological concern at this time, and

the additional uncertainty factor is not

needed to protect the safety of infants

and children.

The acute dietary risk assessment

used tolerance level residues and 100%

crop-treated information. Further

refinement using anticipated residue

levels and percent crop-treated values

would result in a lower dietary exposure

estimate.

The chronic dietary risk assessment

was partially refined using anticipated

residue levels and percent crop-treated

values for selected commodities. This

risk estimate should be viewed as

conservative; further refinement using

anticipated residue levels and percent

crop-treated values for all commodities

included in the analysis would result in

lower dietary exposure estimates.

Therefore, EPA concludes that there is

reasonable certainty that no harm will

result to infants and children from

aggregate exposure to propiconazole

residues.

V. Other Considerations

The metabolism of propiconazole in

plants and animals is adequately

understood for the purposes of these

tolerance actions. There is a Codex

maximum residue level (MRL) of 0.05

ppm for residues of propiconazole in/on

almonds. The Section 18 tolerance on

almond nut meats is proposed at 0.1

ppm and that on almond hulls at 2.5

ppm. The available field trial data on

almonds do not support harmonization

with the Codex MRL of 0.05 ppm

because they indicate that residues used

under the use patterns approved for the

emergency exemption could exceed 0.05

ppm. There are no Canadian or Mexican

levels established for residues of

propiconazole on almonds. There are no

Mexican, Canadian, or Codex MRLs

established for residues of

propiconazole on cranberries. There are

practical analytical methods for

detecting and measuring levels of

propiconazole in or on food with a limit

of detection that allows monitoring of

food with residues at or above the levels

set in these tolerances. EPA has

provided information on these method

to FDA. These methods have been

approved for publication in PAM II for

enforcement purposes, but have not yet

appeared in PAM II. In the interim, a

copy of the methods is available to

anyone who is interested in pesticide

residue enforcement from: By mail,

Calvin Furlow, Public Response and

Program Resources Branch, Field

Operations Division (7506C), Office of

Pesticide Programs, Environmental

Protection Agency, 401 M St. SW.,

Washington, DC 20460. Office location

and telephone number: Crystal Mall #2,

Rm 1128, 1921 Jefferson Davis Hwy.,

Arlington, VA, 703-305-5805.

VI. Conclusion

Therefore, time-limited tolerances in

connection with the FIFRA section 18

emergency exemptions are established

for residues of propiconazole in or on

almond nutmeats at 0.1 part per million

(ppm), in or on almond hulls at 2.5 ppm

and in on or cranberries at 1.0 ppm.

VII. 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 new

section 408(e) and (l)(6) as was provided

in the old section 408 and in section

409. However, the period for filing

objections is 60 days, rather than 30

days. EPA currently has procedural

regulations which govern 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 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 above (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 issues on which

a hearing is requested, the requestor’s

contentions on such issues, and a

summary of any evidence relied upon

by the requestor (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 genuine and substantial issue

of fact; there is a reasonable possibility

that available evidence identified by the

requestor would, if established, resolve

one or more of such issues in favor of

the requestor, taking into account

uncontested claims or facts to the

contrary; and resolution of the factual

issues 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 part or all of that information as

Confidential Business Information (CBI).

Information so marked 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.

VIII. Public Docket

A record has been established for this

rulemaking under docket control

number [OPP–300474]. A public version

of this record, which does not include

any information claimed as CBI, is

available for inspection from 8 a.m. to

4:30 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.

The official record for this

rulemaking, as well as the public

version, as described above, is kept in

paper form. Accordingly, in the event

there are objections and hearing

requests, EPA will transfer any copies of

objections and hearing requests received
17716 Federal Register / Vol. 62, No. 70 / Friday, April 11, 1997 / Rules and Regulations

electronically into printed, paper form

as they are received and will place the

paper copies in the official rulemaking

record. The official rulemaking record is

the paper record maintained at the

address in ‘‘ADDRESSES’’ at the

beginning of this document.

IX. Regulatory Assessment

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

as defined by the Paperwork Reduction

Act, 44 U.S.C. 3501 et seq., it is not

subject to review by the Office of

Management and Budget.

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), entitled Enhancing

the Intergovernmental Partnership, or

special consideration as required by

Executive Order 12898 (59 FR 7629,

February 16, 1994).

Because FFDCA section 408(l)(6)

permits establishment of this regulation

without a notice of proposed

rulemaking, the regulatory flexibility

analysis requirements of the Regulatory

Flexibility Act, 5 U.S.C. 604(a), do not

apply. 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

generic matter, that there is no adverse

impact. (46 FR 24950, May 4, 1981).

Under 5 U.S.C. 801(a)(1)(A) of the

Small Business Regulatory Enforcement

Fairness Act of 1996 (Title II of Pub. L.

104-121, 110 Stat. 847), 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 the 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 in 40 CFR Part 180

Environmental protection,

Administrative practice and procedure,

Agricultural commodities, Pesticides

and pests, Reporting and recordkeeping

requirements.

Dated:April 4, 1997.

Penelope A. Fenner-Crisp,

Acting Director, Office of Pesticide Programs.

Therefore, 40 CFR chapter I is

amended as follows:

PART 180—[AMENDED]

1. The authority citation for part 180

continues to read as follows:

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

2. By revising § 180.434 to read as

follows:

§ 180.434 1-[[2-(2,4-dichlorophenyl)-4-

propyl-1,3-dioxolan-2-yl]methyl]-1H-1,2,4-

triazole; tolerances for residues.

(a) General. Tolerances are

established for the combined residues of

the fungicide 1-[[2-(2,4-dichlorophenyl)-

4-propyl-1,3-dioxolan-2-yl] methyl]-1H1,2,4-triazole and its metabolites

determined as 2,4-dichlorobenzoic acid

and expressed as parent compound in or

on the following commodities:

Commodity Parts per

million

Expiration

Date

Apricots ......... 1.0 None

Bananas ........ 0.2 None

Barley, grain .. 0.1 None

Barley, straw 1.5 None

Cattle, fat ....... 0.1 None

Cattle, kidney 2.0 None

Cattle, liver .... 2.0 None

Cattle, mbyp

(except kidney and

liver) ........... 0.1 None

Cattle, meat ... 0.1 None

Celery ............ 5.0 None

Corn, fodder .. 12 December 31,

1998

Corn, forage .. 12 December 31,

1998

Corn, grain .... 0.1 December 31,

1998

Corn, sweet

(kernels,

plus cobs

with husks

removed) ... 0.1 December 31,

1998

Eggs .............. 0.1 None

Goats, fat ...... 0.1 None

Goats, kidney 2.0 None

Goats, liver .... 2.0 None

Goats, mbyp

(except kidney and

liver) ........... 0.1 None

Goats, meat .. 0.1 None

Grass, forage 0.5 None

Grass, hay

(straw) ........ 40 None

Grass, seed

screenings 60 None

Hogs, fat ........ 0.1 None

Hogs, kidney 2.0 None

Hogs, liver ..... 2.0 None

Commodity Parts per

million

Expiration

Date

Hogs, mbyp

(except kidney and

liver) ........... 0.1 None

Hogs meat ..... 0.1 None

Horses, fat ..... 0.1 None

Horses, kidney ............. 2.0 None

Horses, liver .. 2.0 None

Horses, mbyp

(except kidney and

liver) ........... 0.1 None

Horses, meat 0.1 None

Milk ................ 0.05 None

Mushrooms ... 0.1 None

Nectarines ..... 1.0 None

Oats, forage .. 10.0 None

Oats, grain .... 0.1 None

Oats, hay ....... 30.0 None

Oats, straw .... 1.0 None

Peaches ........ 1.0 None

Peanuts ......... 0.2 December 31,

1998

Peanuts, hay 20.0 December 31,

1998

Peanuts, hulls 1.0 December 31,

1998

Pecans .......... 0.1 None

Pineapple ...... 0.1 December 31,

1998

Pineapple,

fodder ........ 0.1 December 31,

1998

Plums ............ 1.0 None

Poultry, fat ..... 0.1 None

Poultry, kidney 0.2 None

Poultry, liver .. 0.2 None

Poultry, mbyp

(except kidney and

liver) ........... 0.1 None

Poultry, meat 0.1 None

Prunes, fresh 1.0 None

Rice, grain ..... 0.1 None

Rice, straw .... 3.0 None

Rye, grain ...... 0.1 None

Rye, straw ..... 1.5 None

Sheep, fat ...... 0.1 None

Sheep, kidney 2.0 None

Sheep, liver ... 2.0 None

Sheep, mbyp

(except kidney and

liver) ........... 0.1 None

Sheep, meat .. 0.1 None

Stonefruit

group ......... 1.0 None

Wheat, grain .. 0.1 None

Wheat, straw 1.5 None

(b) Section 18 emergency exemptions.

Time-limited tolerances are established

permitting the combined residues of 1-

[[2-(2,4-dichlorophenyl)-4-propyl-1,3-

dioxolan-2-yl]methyl]-1H-1,2,4-triazole

and its metabolites determined as 2,4-

dichlorobenzoic acid and expressed as

parent compound, in connection with

use of the pesticide under section 18

emergency exemptions granted by EPA.
Federal Register / Vol. 62, No. 70 / Friday, April 11, 1997 / Rules and Regulations 17717

Residues in these commodities not in

excess of the established tolerances

resulting from the uses described in this

paragraph remaining after expiration of

the time-limited tolerances will not be

considered to be actionable if the

pesticide is applied during the term of

and in accordance with the provisions

of this paragraph. The tolerances are

specified in the following table. These

tolerances expire on the date specified

in the table.

Commodity Parts per

million

Expiration/

Revocation

Date

Almond hull ... 2.5 July 31, 1998

Almond nut

meats ......... 0.1 July 31, 1998

Cranberries ... 41.0 July 31, 1998

Grain sorghum .......... 0.1 October 31,

1998

Grain sorghum stover 1.5 October 31,

1998

(c) Tolerances with regional

registrations. A tolerance with regional

registration, as defined in § 180.1(n), is

established for residues of 1-[[2-(2,4-

dichlorophenyl)-4-propyl-1,3-dioxolan2-yl]methyl]-1H-1,2,4-triazole and its

metabolites determined as 2,4-

dichlorobenzoic acid and expressed as

parent compound, in or on the

following commodities:

Commodity Parts per

million

Mint, tops (leaves and stems) .. 0.3

Wild rice .................................... 0.5

(d) Indirect or inadvertent residues.

[Reserved]

[FR Doc. 97–9371 Filed 4–10–97; 8:45 am]

BILLING CODE 6560–50–F

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Part 180

[OPP–300463; FRL–5597–3]

RIN No. 2070–AB78

Phosphinothricin Acetyltransferase

and the Genetic Material Necessary for

Its Production in All Plants; Exemption

From the Requirement of a Tolerance

On All Raw Agricultural Commodities

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Final rule.

SUMMARY: This document establishes an

exemption from the requirement of a

tolerance for residues of the plantpesticide inert ingredients

Phosphinothricin Acetyltransferase

(PAT) and the genetic material

necessary for its production in all plants

when used as plant-pesticides in or on

all raw agricultural commodities

(RACs). Dekalb Genetics Corporation

submitted a petition to EPA under the

Federal Food, Drug, and Cosmetic Act

(FFDCA) as amended by the Food

Quality Protection Act of l996 (FQPA)

requesting the exemption from the

requirement of a tolerance. This

regulation eliminates the need to

establish a maximum permissible level

for residues of this plant-pesticides in or

on all RACS.

EFFECTIVE DATE: This regulation

becomes effective on April 11, 1997.

ADDRESSES: Written objections and

hearing requests, identified by the

docket control number, [OPP–300463],

may 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 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

copy of objections and hearing requests

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

Davis Highway., Arlington, VA. A copy

of objections and hearing requests filed

with the Hearing Clerk may also be

submitted electronically to the OPP 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 control number [OPP–

300463]. 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 submissions

can be found in Unit VIII. of this

preamble.

FOR FURTHER INFORMATION CONTACT: By

mail: Mike Mendelsohn, Biopesticides

and Pollution Prevention Division,

Office of Pesticide Programs, U. S.

Environmental Protection Agency, 401

M St., SW., Washington, DC 20460.

Office location, telephone number, and

e-mail address: 5th Floor CS, 2800

Crystal Drive, Arlington, VA 22202,

(703)–308–8715); email:

mendelsohn.mike@epamail.epa.gov.

SUPPLEMENTARY INFORMATION: In the

Federal Register of January 24, 1996 (62

FR 3682)(FRL–5380–2), EPA issued a

notice pursuant to section 408(d) of

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

the filing of a pesticide petition for an

exemption from the requirement for a

tolerance by Dekalb Genetics

Corporation (Dekalb), 3100 Sycamore

Road, Dekalb, IL 60115. The notice

contained 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

(Pub. L. 104–170). The petition

requested that an exemption from the

requirement of a tolerance be

established for the plant-pesticides PAT

and the genetic material necessary for

its production in plants in or on all raw

agricultural commodities (RACS). There

were no comments or requests for

referral to an advisory committee

received in response to the notice of

filing. The data submitted in the

petition and other relevant material

have been evaluated. The toxicology

and other data listed below were

considered in support of this exemption

from the requirement of a tolerance.

I. Toxicological Profile

The data submitted regarding

potential health effects of PAT include

information on the characterization of

the expressed protein in corn, the acute

oral toxicity of PAT, and in vitro

digestibility studies of the protein. The

results of these studies were determined

applicable to evaluate human risk and

the validity, completeness, and

reliability of the available data from the

studies were considered.

The acute oral toxicity test of

bacterially-derived PAT protein showed

no test substance related deaths at a

dose of 2,500 milligrams per kilogram

(mg/kg). Residue chemistry data were

not required for a human health effects

assessment of the subject plant-pesticide

inert ingredients because of the lack of

mammalian toxicity. Both (1) available

information concerning the dietary