62986 Federal Register / Vol. 62, No. 228 / Wednesday, November 26, 1997 / Rules and Regulations

* * * * *

[FR Doc. 97–31100 Filed 11–25–97; 8:45 am]

BILLING CODE 6560–50–F

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Part 180

[OPP–300568; FRL–5750–9]

RIN 2070–AB78

Hexythiazox; Pesticide Tolerances for

Emergency Exemptions

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Final rule.

SUMMARY: This regulation establishes a

time-limited tolerance for combined

residues of hexythiazox (trans-5-(4-

chlorophenyl) -N-cyclohexyl-4-methyl2- oxothiazolidine-3-carboxamide) and

its metabolites containing the (4-

chlorophenyl)-4-methyl in or on cotton,

undelinted seed, and cotton gin

byproducts. This action is in response to

EPA’s granting of an emergency

exemption under section 18 of the

Federal Insecticide, Fungicide, and

Rodenticide Act authorizing use of the

pesticide on cotton in California. This

regulation establishes a maximum

permissible level for residues of

hexythiazox in this food commodity

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

Federal Food, Drug, and Cosmetic Act,

as amended by the Food Quality

Protection Act of 1996. The tolerance

will expire and be revoked on October

1, 1998.

DATES: This regulation is effective

November 26, 1997. Objections and

requests for hearings must be received

by EPA on or before January 26, 1998.

ADDRESSES: Written objections and

hearing requests, identified by the

docket control number, [OPP–300568],

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–

300568], must also be submitted to:

Public Information and Records

Integrity Branch, Information Resources

and Services Division (7502C), 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 5.1/6.1 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–

300568]. 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: David Deegan, 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) 308–9358, e-mail:

deegan.dave@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

a tolerance for combined residues of the

insecticide hexythiazox (trans-5- (4-

chlorophenyl) -N-cyclohexyl-4-methyl2- oxothiazolidine-3-carboxamide) and

its metabolites containing the (4-

chlorophenyl)-4-methyl, in or on cotton,

undelinted seed at 0.1 part per million;

and on cotton gin byproducts at 2.0 part

per million (ppm). This tolerance will

expire and be revoked on October 1,

1998. EPA will publish a document in

the Federal Register to remove the

revoked tolerance 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
Federal Register / Vol. 62, No. 228 / Wednesday, November 26, 1997 / Rules and Regulations 62987

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

hexythiazox on Cotton and FFDCA

Tolerances

The state of California submitted a

request to EPA on April 1, 1997 for a

specific exemption from the

requirements of FIFRA, allowed under

provisions of section 18 of FIFRA, for

the emergency use of hexythiazox on

cotton to control various spider mites

(strawberry spider mite Tetranychus

turkestani, twospotted spider mite T.

urticae, Pacific spider mite T. pacificus,

carmine spider mite T. cinabarinus).

The state contended that an emergency

condition was likely to develop during

the 1997 growing season, due to

conditions which have developed over

the past several years favoring spider

mite infestations on cotton. The state’s

request detailed the lack of effective

non-chemical control measures for this

pest. Additionally, three of the four mite

species have been shown to have

developed resistance to alternative

registered chemicals. Spider mites

attack plants primarily as foliage

feeders. This action reduces plant vigor

and growth, which can lead to reduced

yields and/or nonproductive crops.

During the last several years, wetter

than normal conditions have resulted in

more vegetation outside the irrigated

cotton fields. This habitat has supported

larger numbers of plant bugs, including

mites, which have inflicted increased

losses on cotton fields. On May 29, 1997

EPA allowed the state to invoke it’s

crisis authority under FIFRA section 18

for the use of hexythiazox on cotton for

control of spider mites in California.

After having reviewed the submission,

EPA concurs that emergency conditions

exist for this state.

As part of its assessment of this

emergency exemption, EPA assessed the

potential risks presented by residues of

hexythiazox in or on cotton. 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 this

tolerance without notice and

opportunity for public comment under

section 408(e), as provided in section

408(l)(6). Although this tolerance will

expire and be revoked on October 1,

1998, under FFDCA section 408(l)(5),

residues of the pesticide not in excess

of the amounts specified in the

tolerance remaining in or on cotton,

undelinted seed, and cotton gin

byproducts after that date will not be

unlawful, provided the pesticide was

applied in a manner that was lawful

under FIFRA while these tolerances

were in effect. EPA will take action to

revoke this tolerance earlier if any

experience with, scientific data on, or

other relevant information on this

pesticide indicate that the residues are

not safe.

Because this tolerance is being

approved under emergency conditions

EPA has not made any decisions about

whether hexythiazox meets EPA’s

registration requirements for use on

cotton or whether a permanent tolerance

for this use would be appropriate.

Under these circumstances, EPA does

not believe that this tolerance serves as

a basis for registration of hexythiazox by

a State for special local needs under

FIFRA section 24(c). Nor does this

tolerance serve as the basis for any State

other than California 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 hexythiazox, 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
62988 Federal Register / Vol. 62, No. 228 / Wednesday, November 26, 1997 / Rules and Regulations

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 3 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 7 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 7

days of exposure. (Toxicity results at

lower levels when the dosing duration

is increased.)

Intermediate-term risk results from

exposure for 7 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.

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

nursing and non-nursing infants, <1

year old 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 hexythiazox and to make a

determination on aggregate exposure,

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

time-limited tolerance for combined

residues of hexythiazox (trans-5-(4-

chlorophenyl) -N-cyclohexyl -4-methyl2- oxothiazolidine-3-carboxamide) and

its metabolites containing the (4-

chlorophenyl)-4-methyl on cotton,

undelinted seed at 0.1 ppm, and cotton

gin byproducts at 2.0 ppm. 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 hexythiazox are

discussed below.

1. Acute toxicity. An acute dietary risk

assessment is not required, since EPA

did not identify an acute toxicological

endpoint.

2. Short - and intermediate - term

toxicity. For short and intermediateterm Margin of Exposure (MOE)

calculations, EPA recommended use of

the maternal NOEL of 240 mg/kg/day

from the developmental toxicity study

in rats. At the LEL of 740 mg/kg/day,

there was decreased food consumption,

decreased body weight and increased

ovarian weights.

3. Chronic toxicity. EPA has

established the RfD for hexythiazox at

0.025 milligrams/kilogram/day (mg/kg/

day). This RfD is based on a one year

feeding study in dogs with a NOEL of

2.5 mg/kg/day and an uncertainty factor
Federal Register / Vol. 62, No. 228 / Wednesday, November 26, 1997 / Rules and Regulations 62989

of 100. The LOEL of 12.5 mg/kg/day was

based on hypertrophy of the adrenal

cortex (both sexes).

4. Carcinogenicity. Hexythiazox has

been classified as a Group C chemical

(possible human carcinogen) by the

Cancer Peer Review Committee (CPRC),

based on an increased incidence of

female mouse liver tumors. The

Committee recommended using the Q1*

approach. The Q1* is 0.039 mg/kg/day–1.

B. Exposures and Risks

1. From food and feed uses.

Tolerances have been established (40

CFR 180.448) for the combined residues

of hexythiazox (trans-5-(4-chlorophenyl)

-N-cyclohexyl-4-methyl-2-

oxothiazolidine-3-carboxamide) and its

metabolites containing the (4-

chlorophenyl)-4-methyl, in or on a

variety of raw agricultural commodities.

Risk assessments were conducted by

EPA to assess dietary exposures and

risks from hexythiazox 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 one day or single exposure. The acute

dietary (food only) risk assessment is

not required for this pesticide use, as

the EPA did not identify an acute

dietary risk endpoint.

ii. Chronic exposure and risk. In

conducting this chronic dietary risk

assessment, EPA has made conservative

assumptions -- 100% of cotton seed

commodities (oil and meal) and apple

commodities will contain residues of

hexythiazox and its metabolites and

those residues will be at the level of the

tolerance. Percent crop treated data

were utilized for pear commodities.

These conservative assumptions result

in an overestimate of human dietary

exposure. Thus, in making a safety

determination for this tolerance, EPA is

taking into account this conservative

exposure assessment.

The published tolerances for the

regulated residue of hexythiazox, plus

this proposed Section 18 use result in a

Anticipated Residue Contribution (ARC)

that is equivalent to the following

percentages of the RfD:

U.S. Population <1%

Nursing Infants <1%

Non-Nursing Infants (<1 year old)

<1%

Children (1–6 years old) <1%

Children (7–12 years old) <1%

The subgroups listed above are: (1)

the U.S. population (48 states); and (2)

those for infants and children.

2. From drinking water. Based on

information currently available to EPA,

hexythiazox is considered persistent in

soil. EPA’s current data also indicates

that hexythiazox and soil metabolites

are not likely to leach to groundwater.

There are no established Maximum

Contaminant Levels for residues of

hexythiazox in drinking water. No

health advisory levels for hexythiazox

in drinking water have been established.

Chronic exposure and risk. Because

the Agency lacks sufficient waterrelated 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 hexythiazox to exceed the

RfD if the tolerance being considered in

this document were granted. The

Agency has therefore concluded that the

potential exposures associated with

hexythiazox 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 is granted.

3. From non-dietary exposure.

Hexythiazox is not currently registered

for use on any residential non-food

sites. The Agency does not expect there

to be any meaningful non-dietary

residential exposure to hexythiazox.

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

hexythiazox 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,

hexythiazox does not appear to produce

a toxic metabolite produced by other

substances. According to information

evaluated related to this action,

hexythiazox is a member of the

thiazolidinone class of pesticides and

there are no other members of this class.

For the purposes of this tolerance

action, therefore, EPA has not assumed

that hexythiazox has a common

mechanism of toxicity with other

substances.
62990 Federal Register / Vol. 62, No. 228 / Wednesday, November 26, 1997 / Rules and Regulations

C. Aggregate Risks and Determination of

Safety for U.S. Population

1. Chronic risk. Using the

conservative exposure assumptions

described above, and taking into

account the completeness and reliability

of the toxicity data, EPA has concluded

that dietary exposure (food only) to

hexythiazox will utilize <1% of the RfD

for the U.S. population. The major

identifiable subgroup with the highest

aggregate exposure is non-nursing

infants. 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

hexythiazox in drinking water, 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 hexythiazox

residues.

2. 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. EPA believes that uses of

hexythiazox may constitute a shortand/or intermediate-term exposure

scenario. However, the Agency is not, at

this time, able to complete a

comprehensive residential risk

assessment for many pesticides,

including hexythiazox. Because there

are no residential non-food uses

registered for hexythiazox, and because

there are no other chemicals that share

its class, and based on the lack of an

identified acute toxicological endpoint

for hexythiazox, and the low percentage

(<1%) of the RfD occupied by food and

water, in the best scientific judgment of

EPA, short- and intermediate-term

aggregate risk will not exceed the

Agency’s level of concern.

D. Aggregate Cancer Risk for U.S.

Population

Based on published tolerances (none

are currently pending) and this

proposed section 18 use, an upper

bound lifetime dietary (food only)

cancer risk estimate of 5.9× 10–7 was

calculated for the hexythiazox regulated

residue. The calculation used the

conservative exposure assumptions

described above for generating ARC’s

and amortized the cancer risk over a 70-

year lifetime (i.e., 5/70, for this first year

section 18 use). This section 18 use

contributes 8.0 × 10–8 to the upper

bound lifetime dietary (food only)

cancer risk and 5.7 × 10–9 if the cancer

risk is amortized over a 70-year lifetime.

The cancer risk estimate for the

existing hexythiazox uses plus the

amortized risk estimate for cottonseed

commodities does not exceed EPA’s

level of concern. EPA believes the

registered uses do not constitute a

chronic exposure scenario. Thus, no

non-dietary, non-occupational chronic

exposure to hexythiazox is expected, or

is a factor in aggregate cancer risk.

E. Aggregate Risks and Determination of

Safety for Infants and Children

1. Safety factor for infants and

children. —i. In general. In assessing the

potential for additional sensitivity of

infants and children to residues of

hexythiazox, 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

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.

ii. Developmental toxicity studies— a.

Rats. In the rat developmental study, the

maternal (systemic) NOEL was 240 mg/

kg/day. The maternal LOEL of 720 mg/

kg/day was based on decreased food

consumption and decreased body

weight. The developmental (fetal) NOEL

was 240 mg/kg/day. The developmental

LOEL was based on slight delayed

ossification.

b. Rabbits. In the rabbit

developmental toxicity study, the

maternal (systemic) NOEL was 1,080

mg/kg/day at the highest dose tested

(HDT). The developmental (fetal) NOEL

was 1,080 mg/kg/day at the highest dose

tested.

iii. Reproductive toxicity study. Rats.

In the 2-generation reproductive toxicity

study in rats, the parental (systemic)

NOEL was 20 mg/kg/day. The LOEL of

120 mg/kg/day was based on decreased

body weight and decreased food

consumption. The developmental NOEL

was 20 mg/kg/day. The developmental

LOEL of 120 mg/kg/day was based on

decreased body weight and delayed

maturation. The reproductive NOEL was

120 mg/kg/day at the highest dose

tested.

iv. Pre- and post-natal sensitivity. The

pre- and post-natal toxicology data base

for hexythiazox is complete with respect

to current toxicological 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. In the

developmental study in rats, the

developmental NOEL and LOEL is the

same as the maternal NOEL and LOEL

demonstrating that no extra-sensitivity

for infants and children is present. In

rabbits, there are no maternal or

developmental effects up to the limit

dose of 1,080 mg/kg/day HDT. In the 2-

generation reproductive toxicity study

in rats, there are no pup effects at doses

below maternal effects and the common

effects in both pups and parental

animals decreased body weight also

demonstrates that there is no extrasensitivity for infants and children.

v. Conclusion. Based on the above,

EPA concludes that reliable data

support use of the standard 100-fold

uncertainty factor and that an the

additional safety factor is not needed to

protect the safety of infants and

children.

2. Chronic risk. Using the

conservative exposure assumptions

described above, EPA has concluded

that aggregate exposure to hexythiazox

from food will utilize is less than 1% of

the RfD for infants and children. 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 hexythiazox in drinking

water and from non-dietary, nonoccupational exposure, EPA does not
Federal Register / Vol. 62, No. 228 / Wednesday, November 26, 1997 / Rules and Regulations 62991

expect the aggregate exposure to exceed

100% of the RfD. Therefore, taking into

account the completeness and reliability

of the toxicity data, the conservative

exposure assessment and the fact that

residential uses do not fall under a

chronic exposure scenario, EPA

concludes that there is a reasonable

certainty that no harm will result to

infants and children from aggregate

exposure to hexythiazox residues.

V. Other Considerations

A. Metabolism In Plants and Animals

1. For the purpose of this section 18

request, the nature of the residue in

plants is adequately understood. The

residue of concern is hexythiazox and

its metabolites containing the (4-

chlorophenyl)-4-methyl-2-oxo-3-

thiazolidine moiety (as specified in 40

CFR 180.448).

2. Although no livestock commodity

tolerances are established, the nature of

the residue in animals is considered to

be understood. The residue of concern

is hexythiazox and its metabolites

containing the (4-chlorophenyl)-4-

methyl-2-oxo-3-thiazolidine moiety.

B. Analytical Enforcement Methodology

Adequate methods to enforce the

tolerance expression have been

submitted for publication in PAM II.

The approved method is designated as

AMR 985-87 which has been used in a

variety of commodities. This method is

available in PP 5F3254, and by request

from U.S. EPA, IRSD/PIRIB (7502C), 401

M St., SW., Washington DC 20460.

C. Magnitude of Residues

1. Residues of hexythiazox and its

metabolites containing the (4-

chlorophenyl)-4-methyl-2-oxo-3-

thiazolidine moiety (expressed as parent

compound) are not expected to exceed

0.10 ppm in/on cotton, undelinted seed.

A time-limited tolerance is being

established at this level.

2. It is unknown if residues will

concentrate in processed products of

cotton seed. Therefore, the tolerance

level for the RAC has been adjusted to

account for any possible concentration

of the residue. Additional tolerances on

processed products of cotton are not

required for this section 18 request.

3. Residue data are not available for

cotton gin byproducts. For the purpose

of this section 18 request, EPA has

estimated residue levels in cotton gin

byproducts. A search by EPA of the data

currently available indicates two

chemicals for which tolerances are

established on both cotton gin

byproducts and cotton seed. One use is

for an at-planting use of an insecticide.

The other cotton seed/cotton gin

byproducts tolerance pair, 6 ppm and

100 ppm respectively, was established

for a preharvest desiccant use of a

herbicide. Since this preharvest

desiccant use would be considered a

worst case scenario, the hexythiazox

residues on cotton gin byproducts will

be estimated based on the concentration

factor from that use, 16.6 × (100/6).

Thus, EPA estimates that the residue

level of hexythiazox on cotton gin

byproducts will be 2 ppm. A timelimited tolerance is being established at

2 ppm for hexythiazox residues in/on

cotton gin byproducts. EPA notes that

residue data for hexythiazox in/on

cotton gin byproducts will be required

for a section 3 registration decision to be

made.

4. Tolerances for secondary residues

of hexythiazox in livestock commodities

are not established. Livestock feedstuffs

for cattle (dairy and beef), poultry

(discussed below)and swine are derived

from cotton (meal,seed, and hulls). The

maximum dietary burden from

established tolerances on apples and

this time-limited tolerance are 0.53 ppm

for beef cattle, and 0.51 ppm for dairy

cattle. EPA has previously reviewed a

hexythiazox feeding study in dairy

cows, in which the only measurable

residues were in kidney and liver. For

the purpose of this time-limited

tolerance, EPA has translated these data

to swine commodities. Based upon

available data, EPA would not expect

detectable residues of hexythiazox and

its metabolites in commodities derived

from cattle (beef and dairy), and swine.

5. Poultry feedstuffs are derived from

cotton (cotton seed meal). Data

concerning the potential for secondary

residues in poultry are available. The

maximum dietary burden from poultry,

resulting from use associated with this

time-limited tolerance is 0.02 ppm.

Hexythiazox tolerances are not

established on other poultry feed items.

Based upon the total radioactive residue

levels from the poultry metabolism

study, tolerances for secondary residues

of hexythiazox in poultry commodities

are not required for this section 18

request.

D. International Residue Limits

There are no Codex, Canadian or

Mexican maximum residue limits

established for hexythiazox and its

metabolites on cotton seed. Thus,

harmonization is not an issue for this

time-limited tolerance.

E. Rotational Crop Restrictions

As hexythiazox is not registered for

use on crops that are typically rotated,

rotational crop data are not available

and rotation crop restrictions are not

present on the hexythiazox label.

Therefore, EPA cannot determine the

potential for uptake of residues into

crops that may be rotated into

hexythiazox treated fields. In the

absence of data, the following rotational

crop restriction has been added to the

section 18 product label: ‘‘In order to

avoid illegal residues, do not rotate

treated fields to crops, other than cotton,

for one year following application of

hexythiazox. After one year following

application of Hexythiazox, any crops

may be rotated into treated fields.’’

VI. Conclusion

Therefore, the tolerance is established

for combined residues of hexythiazox

(trans-5-(4-chlorophenyl) -N-cyclohexyl4-methyl-2- oxothiazolidine-3-

carboxamide) and its metabolites

containing the (4-chlorophenyl)-4-

methyl in cotton, undelinted seed at 0.1

ppm, and on cotton gin byproducts at

2.0 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 January 26, 1998

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
62992 Federal Register / Vol. 62, No. 228 / Wednesday, November 26, 1997 / Rules and Regulations

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

The official record for this

rulemaking, as well as the public

version, has been established for this

rulemaking under docket control

number [OPP–300568] (including

comments and data submitted

electronically as described below). 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 official rulemaking record

is located at the Virginia address in

‘‘ADDRESSES’’ at the beginning of this

document.

Electronic comments can 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. Comment and data will

also be accepted on disks in

Wordperfect 5.1/6.1 or ASCII file

format. All comments and data in

electronic form must be identified by

the docket control number [OPP–

300568]. Electronic comments on this

rule may be filed online at many Federal

Depository Libraries.

IX. Regulatory Assessment

Requirements

This final rule establishes a tolerance

under FFDCA section 408(d). 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 this tolerance does

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 29, 1997.

Peter Caulkins,

Acting Director, Registration Division, 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. Section 180.448 is amended as

follows:

i. By designating the existing text as

paragraph (a) and adding a heading.

ii. Adding paragraph (b) with a

heading.

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

and reserved with headings.

§ 180.448 Hexythiazox; tolerances for

residues.

(a) General. * * *

(b) Section 18 emergency exemptions.

Time-limited tolerances are established

for the combined residues of the

insecticide hexythiazox and its

metabolites containing the (4-

chlorophenyl)-4-methyl in connection

with use of the pesticide under section

18 emergency exemptions granted by

EPA. These tolerances will expire and

are revoked on the dates specified in the

following table.

Commodity Parts per million Expiration/Revocation Date

cotton seed, undelinted ....................................................................... 0.1 10/1/98

cotton gin byproducts .......................................................................... 2.0 10/1/98
Federal Register / Vol. 62, No. 228 / Wednesday, November 26, 1997 / Rules and Regulations 62993

(c) Tolerances with regional

registrations. [Reserved]

(d) Indirect or inadvertent residues.

[Reserved]

[FR Doc. 97–31104 Filed 11–25–97; 8:45 am]

BILLING CODE 6560–50–F

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Parts 180 and 185

[OPP–300584; FRL–5756–2]

RIN 2070–AB78

Deltamethrin and Tralomethrin;

Pesticide Tolerances

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Final rule.

SUMMARY: This regulation establishes

tolerances for residues of deltamethrin

and tralomethrin in or on: deltamethrin-

-cottonseed at 0.04 parts per million

(ppm) and cottonseed oil at 0.2 ppm;

and tralomethrin--broccoli at 0.50 ppm,

cottonseed at 0.02 ppm, lettuce, head at

1.00 ppm, lettuce, leaf at 3.00 ppm,

soybeans at 0.05 ppm, sunflower seed at

0.05 ppm and cottonseed oil at 0.20

ppm. It also removes time limitations

for tolerances for residues of

deltamethrin and tralomethrin on the

same commodities that expire on

November 15, 1997. AgrEvo USA

Company 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). These tolerances were

established under petition numbers PP

2F4055, PP 6F3436, PP 4F2993, and PP

6F3309.

DATES: This regulation is effective

November 26, 1997. Objections and

requests for hearings must be received

by EPA on or before January 26, 1998.

ADDRESSES: Written objections and

hearing requests, identified by the

docket control number, OPP–300584,

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–

300584, must also be submitted to:

Public Information and Records

Integrity Branch, Information Resources

and Services Division (7502C), 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 5.1/6.1 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–300584.

No Confidential Business Information

(CBI) should be submitted through email. 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: John Hebert, 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) 308–3068, e-mail:

hebert.john@epamail.epa.gov.

SUPPLEMENTARY INFORMATION: On August

16, 1995 and September 15, 1985, EPA

established time limited tolerances

under section 408 of the Federal Food

Drug and Cosmetic Act (FFDCA), 21

U.S.C. 346 a(d) and 348 for residues of

deltamethrin (60 FR 42455) (FRL–4966–

3) and tralomethrin (50 FR 37851)

respectively, on cottonseed. These

tolerances expire on November 15,

1997. AgrEvo USA Company, on

September 15, 1997, requested that the

time limitation for tolerances

established for residues of the

insecticides deltamethrin on cottonseed

at 0.04 ppm and cottonseed oil at 0.2

ppm; and tralomethrin on broccoli at

0.50 ppm, cottonseed at 0.02 ppm,

lettuce, head at 1.00 ppm, lettuce, leaf

at 3.00 ppm, soybeans at 0.05 ppm,

sunflower seed at 0.05 ppm and

cottonseed oil at 0.20 ppm, be removed

based on ecological and environmental

effects data that they had submitted as

a condition of the registration and timelimited tolerances. AgrEvo USA

Company also submitted a summary of

its petition as required under the

FFDCA as amended by the Food Quality

Protection Act (FQPA) of 1996 (Pub. L.

104–170). In the Federal Register of

September 25, 1997 (62 FR 50337)

(FRL–5848–2), 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) for a

tolerance by AgrEvo USA Company.

This notice included a summary of the

petition prepared by AgrEvo USA

Company (acting as registered US agent

for Hoechst Schering AgrEvo, S. A.,

Little Falls Centre, 2711 Centerville

Road, Wilmington, DE 19808, the

registrant. There were no comments

received in response to the notice of

filing.

The basis for time limited tolerances

that expire November 15, 1997, was

given in the October 20, 1993 Federal

Register (58 FR 54094). These timelimited tolerances were predicated on

the expiration of pesticide product

registrations that were made conditional

due to lack of certain ecological and

environmental effects data. The

rationale for using time-limited

tolerances was to encourage pesticide

manufacturers to comply with the

conditions of registration in a timely

manner. There is no regulatory

requirement to make tolerances timelimited due to the conditional status of

a product registration under the Federal

Insecticide, Fungicide, Rodenticide Act

(FIFRA) as amended. It is current EPA

policy to no longer establish time

limitations on tolerance(s) with

expiration dates if none of the

conditions of registration have any

bearing on human dietary risk. The

current petition action meets that

condition and thus the expiration dates

associated with specific crop tolerances

are being deleted.

Deltamethrin and tralomethrin are

being combined for analysis under

FQPA because tralomethrin is rapidly

metabolized by animals to deltamethrin

as a result of debromination. Results of

the rat metabolism study supports this

action.

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