Federal Register / Vol. 62, No. 204 / Wednesday, October 22, 1997 / Rules and Regulations 55771

comment would be impracticable

because of the limited time provided for

making this determination, and would

be contrary to the public interest

because it would divert agency

resources from the critical substantive

review of the section 126 petitions.

C. Effective Date Under the APA

Today’s action will be effective on

October 14, 1997. Under the APA, 5

U.S.C. 553(d)(3), agency rulemaking

may take effect before 30 days after the

date of publication in the Federal

Register if the agency has good cause to

mandate an earlier effective date.

Today’s action—a deadline extension—

must take effect immediately because its

purpose is to move back by one month

the October 14, 1997 deadlines for

several of the section 126 petitions, and

the deadlines for the other section 126

petitions that follow shortly thereafter.

Moreover, EPA intends to use

immediately the one-month extension

period to continue to develop an

appropriate schedule for ultimate action

on the section 126 petitions, and to

continue to develop the technical

analysis needed to develop the notice of

proposed rulemaking. These reasons

support an effective date prior to 30

days after the date of publication.

D. Executive Order 12866

The Office of Management and Budget

has exempted this regulatory action

from Executive Order 12866 review.

E. Unfunded Mandates

Under the Unfunded Mandates

Reform Act of 1995, 2 U.S.C. 1501 et

seq., EPA must undertake various

actions in association with proposed or

final rules that include a Federal

mandate that may result in estimated

costs of $100 million or more to the

private sector or to State, local, or tribal

governments in the aggregate. In

addition, before EPA establishes any

regulatory requirements that may

significantly or uniquely affect small

governments, EPA must have developed

a small government agency plan. EPA

has determined that these requirements

do not apply to today’s action because

this rulemaking (i) is not a Federal

mandate—rather, it simply extends the

date for EPA action on a rulemaking;

and (ii) contains no regulatory

requirements that might significantly or

uniquely affect small governments.

F. Regulatory Flexibility Act

Under the Regulatory Flexibility Act

(RFA), 5 U.S.C. 600 et seq., EPA must

propose a regulatory flexibility analysis

assessing the impact on small entities of

any rule subject to the notice-andcomment rulemaking requirements.

Because this action is exempt from such

requirements, as described above, it is

not subject to RFA.

G. Submission to Congress and the

General Accounting Office

Under 5 U.S.C. of the APA, 5 U.S.C.

801(a)(1)(A), as added by the Small

Business Regulatory Enforcement

Fairness Act of 1996 (SBREFA), EPA

submitted, by the date of publication of

this rule, 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. This rule is not a ‘‘major rule’’

as defined by 5 U.S.C. 804(2), as

amended.

H. Paperwork Reduction Act

This rule does not contain any

information collection requirements

which require OMB approval under the

Paperwork Reduction Act (44 U.S.C.

3501 et seq.)

I. Judicial Review

Under CAA section 307(b)(1), a

petition to review today’s action may be

filed in the Court of Appeals for the

District of Columbia within 60 days of

October 22, 1997.

Dated: October 14, 1997.

Carol M. Browner,

Administrator.

[FR Doc. 97–27977 Filed 10–21–97; 8:45 am]

BILLING CODE 6560–50–P

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Part 180

[OPP–300560; FRL–5746–6]

RIN 2070–AB78

Spinosad; Pesticide Tolerances for

Emergency Exemptions

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Final rule.

SUMMARY: This regulation establishes

time-limited tolerances for spinosad

(Factors A and D) in or on fruiting

vegetables (except cucurbits) crop group

(8), tomato paste, leafy vegetables

(except Brassica vegetables) crop group

(4), and Brassica (cole) leafy vegetables

crop group (5). This action is in

response to EPA’s granting of emergency

exemptions under section 18 of the

Federal Insecticide, Fungicide, and

Rodenticide Act authorizing use of the

pesticide on fruiting vegetables (except

cucurbits) crop group (8), leafy

vegetables (except Brassica vegetables)

crop group (4), and Brassica (cole) leafy

vegetables crop group (5). This

regulation establishes maximum

permissible levels for residues of

spinosad in these food commodities

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 tolerances

will expire and are revoked on

September 30, 1998.

DATES: This regulation is effective

October 22, 1997. Objections and

requests for hearings must be received

by EPA on or before December 22, 1997.

ADDRESSES: Written objections and

hearing requests, identified by the

docket control number, [OPP–300560],

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–

300560], must also be submitted to:

Public Information and Records

Integrity Branch, Information Resources

and Services 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 control number [OPP–

300560]. 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: Pat Cimino, Registration Division

(7505C), Office of Pesticide Programs,

Environmental Protection Agency, 401
55772 Federal Register / Vol. 62, No. 204 / Wednesday, October 22, 1997 / Rules and Regulations

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

Office location, telephone number, and

e-mail address: Crystal Mall #2, 1921

Jefferson Davis Hwy., Arlington, VA,

(703) 308–9357, e-mail:

cimino.pat@epamail.epa.gov.

SUPPLEMENTARY INFORMATION: EPA, on

its own initiative, 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 insecticide

spinosad (Factors A and D) in or on

fruiting vegetables (except cucurbits)

crop group (8), tomato paste, leafy

vegetables (except Brassica vegetables)

crop group (4), and Brassica (cole) leafy

vegetables crop group (5) at 0.25, 0.50,

10.0 and 10.0 parts per million (ppm)

respectively. These tolerances will

expire and are revoked on September

30, 1998. EPA will publish a document

in the Federal Register to remove the

revoked tolerances from the Code of

Federal Regulations.

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) of the

FFDCA 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 and in

residential settings, 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) of the FFDCA

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. Such

tolerances can be established without

providing notice or period for public

comment.

Because decisions on section 18-

related tolerances must proceed before

EPA reaches closure on several policy

issues relating to interpretation and

implementation of the FQPA, EPA does

not intend for its actions on such

tolerances to set binding precedents for

the application of section 408 and the

new safety standard to other tolerances

and exemptions.

II. Emergency Exemption for Spinosad

on Fruiting Vegetables (except

Cucurbits) Crop Group (8), Leafy

Vegetables (except Brassica Vegetables)

Crop Group (4), and Brassica (Cole)

Leafy Vegetables Crop Group (5) and

FFDCA Tolerances

Florida Department of Agriculture &

Consumer Services submitted a regional

specific exemption request for Florida,

Georgia and Arkansas for the use of

spinosad (Spintor 2SC) to control

Western Flower Thrips, Frankliniella

occidentalis, on tomatoes, peppers,

eggplant and other members of fruiting

vegetable (excluding cucurbits) crop

group (8). Season long control measures

for western flower thrip and the disease

that it vectors, tomato spotted wilt virus,

are currently not available and

significant economic losses have already

occurred.

On July 15, 1997 the Arizona

Department of Agriculture requested a

specific exemption for use of spinosad

(Success) to control beet armyworm on

leafy vegetables (except Brassica) crop

group (4) and Brassica leafy vegetables

crop group (5). A specific exemption

request for use of tebufenozide

(Confirm) to control this pest on these

crops in Arizona was granted earlier this

year; however, the state indicates that

tebufenozide alone will not provide

adequate control of beet armyworm in

the fall-season planted crops due to high

pest pressure. Beet armyworm pest

pressure on Arizona’s fall-season

planted crops is, on average, three times

greater than pressure on its winterseason planted crops. Arizona indicates

that both pesticides are needed for the

fall-season planting and is

recommending the following Integrated

Pest Management (IPM) program for use

of both pesticides: (1) spinosad and

tebufenozide may be used where

resistance to currently registered

pesticides is occurring; (2) a total of

three applications per crop of spinosad

are permitted and may be used from

plant emergence to thinning when beet

armyworm populations exceed 1 larva

per 100 plants and after head formation

begins (and comparable susceptibility

stage for non-head forming vegtables in

these crop groups); a total of three

applications per crop of tebufenozide

are permitted from plant emergence to

thinning if beet armyworm populations

are less than 1 larva per 100 plants and

from thinning to head formation. After

having reviewed the requests, EPA

concurs: that emergency conditions

exist for the states and; with Arizona’s

IPM recommendations for use of both

tebufenozide and spinosad for beet

armyworm control under emergency

exemption specifications.

As part of its assessment of this

emergency exemption, EPA assessed the

potential risks presented by residues of

spinosad in or on fruiting vegetables

(except cucurbits) crop group (8),

tomato paste, leafy vegetables (except

Brassica vegetables crop group (4), and

Brassica (cole) leafy vegetables crop

group (5). In doing so, EPA considered

the new safety standard in FFDCA

section 408(b)(2), and EPA decided that

the necessary tolerance under FFDCA

section 408(l)(6) would be consistent

with the new safety standard and with

FIFRA section 18. Consistent with the

need to move quickly on the emergency

exemption in order to address an urgent

non-routine situation 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 in section 408(l)(6). Although

these tolerances will expire and are

revoked on September 30, 1998, under

FFDCA section 408(l)(5), residues of the

pesticide not in excess of the amounts

specified in the tolerances remaining in

or on fruiting vegetables (except

cucurbits) crop group (8), tomato paste,

leafy vegetables (except Brassica

vegetables crop group (4), and Brassica
Federal Register / Vol. 62, No. 204 / Wednesday, October 22, 1997 / Rules and Regulations 55773

(cole) leafy vegetables crop group (5)

after that date will not be unlawful,

provided the pesticide is applied in a

manner that was lawful under FIFRA.

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.

Because these tolerances are being

approved under emergency conditions

EPA has not made any decisions about

whether spinosad meets EPA’s

registration requirements for use on

fruiting vegetables (except cucurbits)

crop group (8), leafy vegetables (except

Brassica vegetables) crop group (4), and

Brassica (cole) leafy vegetables crop

group (5) or whether permanent

tolerances for these uses would be

appropriate. Under these circumstances,

EPA does not believe that these

tolerances serve as a basis for

registration of spinosad by a State for

special local needs under FIFRA section

24(c). Nor do these tolerances serve as

the basis for any State other than

Arizona, Florida, Georgia and Arkansas

to use this pesticide on this crop 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

exemption for spinosad, 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.

Second, EPA examines exposure to the

pesticide through the diet (e.g., food and

drinking water) and through exposures

that occur as a result of pesticide use in

residential settings.

A. Toxicity

1. Threshold and non-threshold

effects. For many animal studies, a dose

response 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

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 percent

or less of the RfD) is generally

considered acceptable by EPA. EPA

generally uses the RfD to evaluate the

chronic risks posed by pesticide

exposure. For shorter term risks, EPA

calculates a margin of exposure (MOE)

by dividing the estimated human

exposure into the NOEL from the

appropriate animal study. Commonly,

EPA finds MOEs lower than 100 to be

unacceptable. This 100-fold MOE is

based on the same rationale as the 100-

fold uncertainty factor.

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 weight

of the evidence review of all relevant

toxicological data including short-term

and mutagenicity studies and structure

activity relationship. Once a pesticide

has been classified as a potential human

carcinogen, different types of risk

assessments (e.g., linear low dose

extrapolations or MOE 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.

2. Differences in toxic effect due to

exposure duration. The toxicological

effects of a pesticide can vary with

different exposure durations. EPA

considers the entire toxicity data base,

and based on the effects seen for

different durations and routes of

exposure, determines which risk

assessments should be done to assure

that the public is adequately protected

from any pesticide exposure scenario.

Both short and long durations of

exposure are always considered.

Typically, risk assessments include

‘‘acute,’’ ‘‘short-term,’’ ‘‘intermediate

term,’’ and ‘‘chronic’’ risks. These

assessments are defined by the Agency

as follows:

Acute risk, by the Agency’s definition,

results from 1-day consumption of food

and water, and reflects toxicity which

could be expressed following a single

oral exposure to the pesticide residues.

High end exposure to food and water

residues are typically assumed.

Short-term risk results from exposure

to the pesticide for a period of 1–7 days,

and therefore overlaps with the acute

risk assessment. Historically, this risk

assessment was intended to address

primarily dermal and inhalation

exposure which could result, for

example, from residential pesticide

applications. However, since enaction of

FQPA, this assessment has been

expanded to include both dietary and

non-dietary sources of exposure, and

will typically consider exposure from

food, water, and residential uses when

reliable data are available. In this

assessment, risks from average food and

water exposure, and high-end

residential exposure, are aggregated.

High-end exposures from all three

sources are not typically added because

of the very low probability of this

occurring in most cases, and because the

other conservative assumptions built

into the assessment assure adequate

protection of public health. However,

for cases in which high-end exposure

can reasonably be expected from

multiple sources (e.g. frequent and

widespread homeowner use in a

specific geographical area), multiple

high-end risks will be aggregated and

presented as part of the comprehensive

risk assessment/characterization. Since

the toxicological endpoint considered in

this assessment reflects exposure over a

period of at least seven days, an

additional degree of conservatism is

built into the assessment; i.e., the risk

assessment nominally covers 1–7 days

exposure, and the toxicological

endpoint/NOEL is selected to be

adequate for at least seven days of

exposure. (Toxicity results at lower

levels when the dosing duration is

increased.)

Intermediate-term risk results from

exposure for seven days to several

months. This assessment is handled in

a manner similar to the short-term risk

assessment.

Chronic risk assessment describes risk

which could result from several months

to a lifetime of exposure. For this

assessment, risks are aggregated

considering average exposure from all

sources for representative population

subgroups including infants and

children.
55774 Federal Register / Vol. 62, No. 204 / Wednesday, October 22, 1997 / Rules and Regulations

B. Aggregate Exposure

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, residues in

groundwater or surface water that is

consumed as drinking water, and other

non-occupational exposures through

pesticide use in gardens, lawns, or

buildings (residential and other indoor

uses). 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. In

evaluating food exposures, EPA takes

into account varying consumption

patterns of major identifiable subgroups

of consumers, including infants and

children. 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.

Percent of crop treated estimates are

derived from federal and private market

survey data. Typically, a range of

estimates are supplied and the upper

end of this range is assumed for the

exposure assessment. By using this

upper end estimate of percent of crop

treated, the Agency is reasonably certain

that exposure is not understated for any

significant subpopulation group.

Further, regional consumption

information is taken into account

through EPA’s computer-based model

for evaluating the exposure of

significant subpopulations including

several regional groups, to pesticide

residues. For this pesticide, the most

highly exposed population subgroup

(non-hispanic other than black or

caucasian subgroup) was not regionally

based.

IV. Aggregate Risk Assessment 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,

EPA has sufficient data to assess the

hazards of spinosad and to make a

determination on aggregate exposure,

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

time-limited tolerances for spinosad

(Factors A and D) in or on fruiting

vegetables (except cucurbits) crop group

(8), tomato paste, leafy vegetables

(except Brassica vegetables) crop group

(4), and Brassica (cole) leafy vegetables

crop group (5) at 0.25, 0.50, 10.0 and

10.0 ppm, respectively. EPA’s

assessment of the dietary exposures and

risks associated with establishing the

tolerance follows.

A. Toxicological Profile

EPA has evaluated the available

toxicity data and considered its validity,

completeness, and reliability as well as

the relationship of the results of the

studies to human risk. EPA has also

considered available information

concerning the variability of the

sensitivities of major identifiable

subgroups of consumers, including

infants and children. The nature of the

toxic effects caused by spinosad are

discussed below.

1. Acute toxicity. None. For acute

dietary risk assessment, the Agency did

not select an endpoint based on

available data and determined that this

risk assessment is not required.

2. Short - and intermediate - term

toxicity. No short- or intermediate-term

toxicological endpoints have been

identified. Therefore, a short- or

intermediate-term aggregate risk

assessment is not required.

3. Chronic toxicity. EPA has

established the RfD for spinosad at

0.0268 milligrams/kilogram/day (mg/kg/

day). The RfD was established based on

a 1-year feeding study in dogs. The

NOEL was 2.68 mg/kg/day with an

uncertainty factor of 100. The LOEL of

8.22 mg/kg/day was based on increases

in serum alanine aminotransferase,

aspartate aminotransferase, and

triglycerides levels, and the presence of

tissue abnormalities including

vacuolated cell aggregations, arteritis,

and glandular cell vacuolation

(parathyroid).

4. Carcinogenicity. The Agency

determined that there was no evidence

of carcinogenicity in two species.

B. Exposures and Risks

1. From food and feed uses. A timelimited tolerance which expires

November 15, 1999 has been established

(40 CFR 180.495) for the residues of

spinosad (Factors A and D) in or on

cottonseed at 0.02 ppm. There are no

other tolerances established for

spinosad. Risk assessments were

conducted by EPA to assess dietary

exposures and risks from spinosad as

follows:

i. Acute exposure and risk. Acute

dietary risk assessments are performed

for a food-use pesticide if a toxicological

study has indicated the possibility of an

effect of concern occurring as a result of

a 1 day or single exposure. No acute

dietary endpoint of concern was

identified by the Agency, therefore this

risk assessment is not required.

ii. Chronic exposure and risk. In

conducting the chronic dietary risk

assessment, the Agency used

conservative TMRC assumptions as

follows: 100% of the leafy vegetables

(except Brassica vegetables) crop group

commodities, Brassica (cole) leafy

vegetables crop group commodities,

fruiting vegetable (except cucurbits)

crop group commodities, and cotton

commodities tolerances will contain

spinosad residues and those residues

will be at the level of the tolerance.

2. From drinking water. Based on

information in the EFED One-liner

Database (updated 5/6/97), spinosad is

not persistent and not mobile. There are

no established Maximum Contaminant

Levels (MCLs) for residues of spinosad

in drinking water. No health advisory

levels for spinosad in drinking water

have been established. There is no entry

for spinosad in EPA’s Pesticides in

Ground Water Database (9/92).

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

exposure from contaminated water, the

ranges the Agency is continuing to

examine are all below the level that

would cause spinosad to exceed the RfD
Federal Register / Vol. 62, No. 204 / Wednesday, October 22, 1997 / Rules and Regulations 55775

if the tolerance being considered in this

document were granted. The Agency

has therefore concluded that the

potential exposures associated with

spinosad 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 tolerance are granted.

3. From non-dietary exposure.

Spinosad is currently registered for

residential, outdoor, non-food sites,

which include: ornamental turf, and

ornamental herbaceous and woody

plants. Under current Agency

guidelines, these uses do not fall under

a chronic scenario, but may constitute a

short- and/or intermediate-term

exposure scenario. However, no shortor intermediate-term toxicological

endpoints of concern have been

identified and the risk assessment is not

required for short- and/or intermediateterm exposure.

4. 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

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

spinosad 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,

spinosad 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 spinosad has a common

mechanism of toxicity with other

substances.

C. Aggregate Risks and Determination of

Safety for U.S. Population

1. Acute risk. No acute dietary

endpoint of concern was identified by

the Agency, so this risk assessment is

not required.

2. Chronic risk. Using the

conservative TMRC exposure

assumptions described above, EPA has

concluded that aggregate exposure to

spinosad from food will utilize 20% of

the RfD for the U.S. population. The

major identifiable subgroup with the

highest aggregate exposure is nonhispanics other than blacks or

caucasians and aggregate exposure to

spinosad from food will utilize 32% of

the RfD for this subpopulation. 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 spinosad in drinking

water, EPA does not expect the

aggregate exposure to exceed 100% of

the RfD. Under current Agency

guidelines, the registered residential

non-dietary uses do not fall under a

chronic scenario. EPA concludes that

there is a reasonable certainty that no

harm will result from chronic aggregate

exposure to spinosad residues from food

and water.

3. Short- and intermediate-term risk.

Short- and intermediate-term aggregate

exposure takes into account chronic

dietary food and water (considered to be

a background exposure level) plus

indoor and outdoor residential

exposure.

Under current Agency guidelines, the

registered residential non-dietary uses

do not fall under a chronic scenario, but

may constitute a short- and/or

intermediate-term exposure scenario.

However, no short- or intermediate-term

toxicological endpoints have been

identified. Therefore, a short- or

intermediate-term aggregate risk

assessment is not required.

D. Aggregate Cancer Risk for U.S.

Population

The Agency determined that there

was no evidence of carcinogenicity in

two species. Therefore, a cancer risk

assessment is not required.

E. Aggregate Risks and Determination of

Safety for Infants and Children

1. Safety factor for infants and

children.— a. In general. In assessing

the potential for additional sensitivity of

infants and children to residues of

spinosad, 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.

FFDCA section 408 provides that EPA

shall apply an additional tenfold margin

of 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 safety will be safe for infants and

children. Margins of safety are

incorporated into EPA risk assessments

either directly through use of a MOE

analysis or through using uncertainty

(safety) factors in calculating a dose

level that poses no appreciable risk to

humans. EPA believes that reliable data

support using the standard MOE and

uncertainty factor (usually 100 for

combined inter- and intra-species

variability)) and not the additional

tenfold MOE/uncertainty factor when

EPA has a complete data base under

existing guidelines and when the
55776 Federal Register / Vol. 62, No. 204 / Wednesday, October 22, 1997 / Rules and Regulations

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 MOE/safety factor.

b. Developmental toxicity studies.— i.

Rats. In the developmental study in rats,

both the maternal (systemic) NOEL and

the developmental (fetal) NOEL were ≥

200 mg/kg/day at the highest dose

tested.

ii. Rabbits. In the developmental

toxicity study in rabbits, both the

maternal (systemic) NOEL and the

developmental (fetal) NOEL were ≥ 50

mg/kg/day at the highest dose tested.

The Agency concluded that spinosad is

not a developmental toxicant.

c. Reproductive toxicity study. Rats.

In the 2-generation reproductive toxicity

study in rats, the parental (systemic)

NOEL was 10 mg/kg/day. The parental

(systemic) LOEL of 100 mg/kg/day was

based on increases in heart, kidney,

liver, spleen, and thyroid weights (both

sexes). In addition, histopathological

lesions were found in the lungs and

mesenteric lymph nodes (both sexes),

stomach (females), and prostate, and

increased incidence of dystocia and/or

vaginal bleeding after parturition with

associated increases in mortality in the

dams. The NOEL for reproductive

toxicity was 10 mg/kg/day. The LOEL

for reproductive toxicity of 100 mg/kg/

day was based on decreases in litter

size, survival (F2 litters), and body

weights in the offspring.

d. Pre- and post-natal sensitivity. The

toxicological data base for evaluating

pre- and post-natal toxicity for spinosad

is complete with respect to current data

requirements. There are no pre- or postnatal toxicity concerns for infants and

children, based on the results of the rat

and rabbit developmental toxicity

studies and the 2-generation rat

reproductive toxicity study.

e. Conclusion. Based on the data

examined above, the Agency concludes

that reliable data support use of the

standard 100-fold uncertainty factor and

that an additional uncertainty factor is

not needed to protect infants and

children.

2. Acute risk. No endpoint of concern

was identified by the Agency, so this

risk assessment is not required.

3. Chronic risk. Using the

conservative exposure assumptions

described above, EPA has concluded

that percentage of the RfD that will be

utilized by dietary exposure to residues

of spinosad from food ranges from 2

percent for nursing infants less than 1

year old, up to 23% for children 7-12

years old. 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

spinosad in drinking water, EPA does

not expect the aggregate exposure to

exceed 100% of the RfD. Under current

Agency guidelines, the registered

residential non-dietary uses do not fall

under a chronic scenario. EPA

concludes that there is a reasonable

certainty that no harm will result to

infants and children from chronic

aggregate (food plus water) exposure to

spinosad residues.

4. Short- or intermediate-term risk.

Short- and intermediate-term aggregate

exposure takes into account chronic

dietary food and water (considered to be

a background exposure level) plus

indoor and outdoor residential uses.

Under current Agency guidelines, the

registered residential non-dietary uses

do not fall under a chronic scenario, but

may constitute a short- and/or

intermediate-term exposure scenario.

However, no short- or intermediate-term

toxicological endpoints have been

identified. Therefore, a short- or

intermediate-term aggregate risk

assessment is not required.

F. Endocrine Disrupter Effects

EPA is required to develop a

screening program to determine whether

certain substances (including all

pesticides and inerts) ‘‘may have an

effect in humans that is similar to an

effect produced by a naturally occurring

estrogen, or such other endocrine

effect...’’ The Agency is currently

working with interested stakeholders,

including other government agencies,

public interest groups, industry and

research scientists in developing a

screening and testing program and a

priority setting scheme to implement

this program. Congress has allowed 3

years from the passage of FQPA (August

3, 1999) to implement this program. At

that time, EPA may require further

testing of this active ingredient and end

use products for endocrine disrupter

effects.

V. Other Considerations

A. Metabolism In Plants and Animals

The nature of the residue in plants is

adequately understood based on

acceptable metabolism studies on

cotton, apples, cabbage, tomatoes, and

turnips. The results of the metabolism

studies have not yet been reviewed by

the Agency’s Metabolism Committee

but, for the purposes of these section

18s only, the residues of concern are the

parent compounds (Factors A and D)

only, as specified in 40 CFR 180.495.

B. Analytical Enforcement Methodology

For the purposes of these section 18

requests, DowElanco method GRM

95.04 high pressure liquid

chromatography/ultraviolet (HPLC/UV)

should be adequate to enforce the

tolerance expression for the fruiting

vegetable (except cucurbits) crop group,

and method GRM 94.22 (HPLC/UV)

should be adequate to enforce the

tolerance expression for the leafy

vegetables (except Brassica vegetables)

crop group and Brassica (cole) leafy

vegetables crop subgroup.

C. Magnitude of Residues

Residues of spinosad (Factors A and

D) are not expected to exceed 0.25 ppm

in/on the fruiting vegetable (except

cucurbits) crop grouping and 0.50 ppm

in/on tomato paste as a result of this

section 18 use. Residues are not

expected to concentrate in/on tomato

puree. Residues of spinosad (Factors A

and D) are not expected to exceed 10

ppm in/on the leafy vegetables (except

Brassica vegetables) crop group and 10

ppm in/on the Brassica (cole) leafy

vegetables crop group as a result of this

section 18 use. Secondary residues are

not expected in animal commodities as

no feed items are associated with these

section 18 uses.

D. International Residue Limits

No Codex, Canadian, and/or Mexican

MRLs tolerances have been established

for spinosad.

E. Rotational Crop Restrictions

The results of a confined rotational

crop study indicate that the parent

compound does not appear to be taken

up and/or be translocated within the

plants tested (wheat, lettuce, and

radish). Pending review of the plant

metabolism and confined rotational

crop studies by the Agency’s

Metabolism Committee, rotational crop

field studies and rotational crop

tolerances will not need to be

established to support future section 3

permanent tolerance requests. For the

purposes of these section 18 requests,

the residues of concern in plants are the

parent compounds (Factors A and D)

only, and rotational crop restrictions

and/or tolerances will not be needed.

VI. Conclusion

Therefore, tolerances are established

for residues of spinosad (Factors A and

D) in or on fruiting vegetables (except

cucurbits) crop group (8), tomato paste,

leafy vegetables (except Brassica

vegetables) crop group (4), and Brassica

(cole) leafy vegetables crop group (5) at

0.25, 0.50, 10.0 and 10.0 ppm

respectively.
Federal Register / Vol. 62, No. 204 / Wednesday, October 22, 1997 / Rules and Regulations 55777

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 December 22,

1997, file written objections to any

aspect of this regulation 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 Record and Electronic

Submissions

EPA has established a record for this

rulemaking under docket control

number [OPP–300560] (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

Rm. 1132 of the Public Information and

Records Integrity Branch, Information

Resources and Services 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 Virginia

address in ‘‘ADDRESSES’’ at the

beginning of this document.

IX. Regulatory Assessment

Requirements

This final rule establishes a timelimited tolerance under FFDCA section

408(d) in response to a petition

submitted to the Agency. The Office of

Management and Budget (OMB) has

exempted these types of actions from

review under Executive Order 12866,

entitled Regulatory Planning and

Review (58 FR 51735, October 4, 1993).

This final rule does not contain any

information collections subject to OMB

approval under the Paperwork

Reduction Act (PRA), 44 U.S.C. 3501 et

seq., or impose any enforceable duty or

contain any unfunded mandate as

described under Title II of the Unfunded

Mandates Reform Act of 1995 (UMRA)

(Pub. L. 104–4). Nor does it require any

prior consultation as specified by

Executive Order 12875, entitled

Enhancing the Intergovernmental

Partnership (58 FR 58093, October 28,

1993), or special considerations as

required by Executive Order 12898,

entitled Federal Actions to Address

Environmental Justice in Minority

Populations and Low-Income

Populations (59 FR 7629, February 16,

1994), or require OMB review in

accordance with Executive Order 13045,

entitled Protection of Children from

Environmental Health Risks and Safety

Risks (62 FR 19885, April 23, 1997).

In addition, since these tolerances and

exemptions that are established on the

basis of a petition under FFDCA section

408 (d), such as the time-limited

tolerance in this final rule, do not

require the issuance of a proposed rule,

the requirements of the Regulatory

Flexibility Act (RFA) (5 U.S.C. 601 et

seq.) do not apply. Nevertheless, the

Agency has previously assessed whether

establishing tolerances, exemptions

from tolerances, raising tolerance levels

or expanding exemptions might

adversely impact small entities and

concluded, as a generic matter, that

there is no adverse economic impact.

The factual basis for the Agency’s

generic certification for tolerance

actions published on May 4, 1981 (46

FR 24950), and was provided to the

Chief Counsel for Advocacy of the Small

Business Administration.

X. Submission to Congress and the

General Accounting Office

Under 5 U.S.C. 801(a)(1)(A), as added

by the Small Business Regulatory

Enforcement Fairness Act of 1996, the

Agency has 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 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: October 1, 1997.

James Jones,

Acting Director, Office of Pesticide Programs.

Therefore, 40 CFR Chapter I is

amended as follows:
55778 Federal Register / Vol. 62, No. 204 / Wednesday, October 22, 1997 / Rules and Regulations

PART 180—[AMENDED]

1. The authority citation for part 180

continues to read as follows:

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

2. Section 180.495 is amended as

follows:

a. By adding a heading to paragraph

(a).

b. In paragraph (b) by adding a

heading and alphabetically adding the

following commodities.

c. Paragraphs (c) and (d) are added

and reserved with headings.

§ 180.495 Spinosad; tolerances for

residues.

(a) General. [Reserved]

(b) Section 18 emergency exemptions.

* * *

Commodity Parts per million Expiration/Revocation Date

Brassica (Cole) Leafy Vegetables Crop Group (5) ............................. 10.0 9/30/98

* * * * * * *

Fruiting Vegetables (except Cucurbits) Crop Group (8) ..................... 0.25 9/30/98

Leafy Vegetables (except Brassica vegetables) Crop Group (4) ....... 10.0 9/30/98

Tomato paste ....................................................................................... 0.50 9/30/98

(c) Tolerances with regional

registrations. [Reserved]

(d) Indirect or inadvertent residues.

[Reserved]

[FR Doc. 97–27727 Filed 10–21–97; 8:45 am]

BILLING CODE 6560–50–F

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Part 180

[OPP–300548; FRL–5742–5]

RIN 2070–AB78

Pyrithiobac Sodium Salt; Time-Limited

Pesticide Tolerance

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Final rule.

SUMMARY: This regulation extends the

time-limited tolerance for residues of

the herbicide pyrithiobac sodium salt

(sodium 2-chloro-6-[(4,6-

dimethoxypyrimidin-2-yl)thio]benzoate)

in or on cottonseed at 0.02 parts per

million (ppm). E.I. du Pont de Nemours

& Co., Inc., requested this tolerance

under the Federal Food, Drug and

Cosmetic Act (FFDCA), as amended by

the Food Quality Protection Act of 1966

(Pub. L. 104–170). The tolerance will

expire on September 30, 1999.

DATES: This regulation is effective

October 22, 1997. Objections and

requests for hearings must be received

by EPA on or before December 22, 1997.

ADDRESSES: Written objections and

hearing requests, identified by the

docket control number, [OPP–300548],

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–

300548], must also be submitted to:

Public Information and Records

Integrity Branch, Information Resources

and Services 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 control number [OPP–

300548]. 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: James A. Tompkins, Registration

Division 7505C, Office of Pesticide

Programs, Environmental Protection

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

DC 20460. Office location, telephone

number, and e-mail address: Crystal

Mall #2, 1921 Jefferson Davis Hwy.,

Arlington, VA, (703) 305–5697, e-mail:

tompkins.james@epamail.epa.gov.

SUPPLEMENTARY INFORMATION: In the

Federal Register of July 11, 1997 (62 FR

37241)(FRL–5728–7), EPA, issued a

notice pursuant to section 408 of the

Federal Food, Drug, and Cosmetic Act

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

the filing of a pesticide petition (PP

4F4391) for tolerance by E.I. du Pont de

Nemours & Co., Inc., Barley Mill Plaza,

P.O. Box 80038, Wilmington, DE 19880–

0038. This notice included a summary

of the petition prepared by du Pont.

There were two comments received in

response to the notice of filing from

cotton growers urging the extension of

the time limited tolerance.

The petition requested that 40 CFR

180.487 be amended by extending the

time-limited tolerance for residues of

the herbicide pyrithiobac sodium salt

(sodium 2-chloro-6-[(4,6-

dimethoxypyrimidin-2-yl)thio]benzoate)

in or on cottonseed at 0.02 ppm. This

tolerance will expire on September 30,

1999.

In the Federal Register of October 25,

1995 (60 FR 54607)(FRL–4982–8), EPA

established a time limited tolerance for

residues of the herbicide pyrithiobac

sodium in or on cottonseed at 0.02 ppm.

The time limited tolerance will expire

on September 30, 1997.

I. Risk Assessment and Statutory

Findings

New section 408(b)(2)(A)(i) of the

FFDCA 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 and in

residential settings, but does not include

occupational exposure. Section

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