Federal Register / Vol. 62, No. 228 / Wednesday, November 26, 1997 / Rules and Regulations 62979

408(d), such as the 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 Advocacy of the

Small Business Administration.

VIII. 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: November 14, 1997.

Stephen L. Johnson,

Acting Director, Office of Pesticide Programs.

Therefore, 40 CFR chapter I is

amended as follows:

PART 180—[AMENDED]

1. The authority citation for part 180

continues to read as follows:

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

2. By adding a new § 180.517 to read

as follows:

§ 180.517 Fipronil; tolerances for residues.

(a) General. Therefore, tolerances are

established for combined residues of the

insecticide fipronil, (5-amino-1-[2,6-

dichloro-4-(trifluoromethyl)phenyl]-4-

[(1R,S)-(trifluoromethyl)sulfinyl]-1Hpyrazole-3-carbonitrile) and its

metabolites 5-amino-1-[2,6-dichloro-4-

(trifluoromethyl)phenyl]-4-

[(trifluoromethyl) sulfonyl]-1Hpyrazole-3-carbonitrile and 5-amino-1-

[2,6-dichloro-4-(trifluoromethyl)

phenyl]-4-[(trifluoromethyl)thio]-1Hpyrazole-3-carbonitrile in or on the

following items at the levels specified:

Commodity

Parts

per million

Corn, field, grain .............................. 0.02

Corn, field, stover ............................. 0.30

Corn, field, forage ............................ 0.15

Eggs ................................................. 0.03

Fat of cattle, goat, horse and sheep 0.40

Hog Fat ............................................ 0.04

Hog Liver .......................................... 0.02

Hog Meat ......................................... 0.01

Hog Meat Byproducts (except liver) 0.01

Liver of cattle, goat, horse and

sheep.

0.10

Milk, fat (reflecting 0.05 ppm in

whole milk).

1.50

Meat Byproducts (except liver) of

cattle, goat, horse and sheep.

0.04

Meat of cattle, goat, horse and

sheep.

0.04

Poultry Fat ........................................ 0.05

Poultry Meat ..................................... 0.02

Poultry Meat Byproducts .................. 0.02

(b) Section 18 emergency exemptions.

[Reserved]

(c) Tolerances with regional

registrations. [Reserved]

(d) Indirect or inadvertent residues.

[Reserved]

[FR Doc. 97–30949 Filed 11–25–97; 8:45 am]

BILLING CODE 6560–50–F

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Part 180

[OPP–300569; FRL–5751–1]

RIN 2070–AB78

Tebufenozide; Pesticide Tolerances for

Emergency Exemptions

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Final rule.

SUMMARY: This regulation establishes a

time-limited tolerance for residues of

tebufenozide in or on sugarcane. 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

sugarcane. This regulation establishes a

maximum permissible level for residues

of tebufenozide 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 December

31, 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–300569],

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–

300569], 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, Crystal Mall #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–

300569]. No Confidential Business

Information (CBI) should be submitted

through e-mail. Electronic copies of

objections and hearing request 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: CM #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
62980 Federal Register / Vol. 62, No. 228 / Wednesday, November 26, 1997 / Rules and Regulations

a tolerance for residues of the

insecticide tebufenozide, in or on

sugarcane at 0.3 part per million (ppm).

This tolerance will expire and be

revoked on December 31, 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

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

tolerance to set binding precedents for

the application of section 408 and the

new safety standard to other tolerances

and exemptions.

II. Emergency Exemption for

Tebufenozide on Sugarcane and FFDCA

Tolerances

On March 27, 1997, EPA received a

request from the Louisiana Department

of Agriculture and Forestry, requesting

that EPA authorize emergency use of

tebufenozide (Confirm 2F Agricultural

Insecticide, EPA Registration No. 707–

238, registered by Rohm and Haas Co.)

on sugarcane to control sugarcane borer,

under provisions of section 18 of FIFRA.

Louisiana’s request for this pesticide use

asserted that the population of

sugarcane borer has chronically attained

levels that can inflict significant damage

to the sugarcane crop. In the past the

preferred method of control had been

with the chemical azinphos-methyl.

However, due to large-scale fish kills

which have resulted from use of

azinphos-methyl, EPA has restricted

that chemical’s use. Although Louisiana

describes their efforts to develop an

integrated pest management program to

control sugarcane borer, they still

require use of chemicals for this

program to succeed. The state requested

use of tebufenozide on up to 60,000

acres of sugarcane, at application rates

of 0.12 lbs. active ingredient per acre,

per application, with a maximum of two

applications allowed during the use

season of June 15 - September 15, 1997.

This use was also requested and

authorized by EPA during the growing

season of 1996. EPA allowed the

Louisiana Department of Agriculture

and Forestry to exercise its authority to

authorize the use of tebufenozide on

sugarcane for control of sugarcane borer

in Louisiana under crisis provisions of

section 18, described in 40 CFR 166.40–

160.53, on June 13, 1997.

As part of its assessment of this

emergency exemption, EPA assessed the

potential risks presented by residues of

tebufenozide in or on sugarcane. 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 December 31,

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 sugarcane

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 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 tebufenozide meets EPA’s

registration requirements for use on

sugarcane 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

tebufenozide 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 Louisiana 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 tebufenozide, 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.
Federal Register / Vol. 62, No. 228 / Wednesday, November 26, 1997 / Rules and Regulations 62981

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 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
62982 Federal Register / Vol. 62, No. 228 / Wednesday, November 26, 1997 / Rules and Regulations

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-nursing infants) 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 tebufenozide and to make a

determination on aggregate exposure,

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

time-limited tolerance for residues of

tebufenozide on sugarcane at 0.3 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 tebufenozide are

discussed below.

1. Acute toxicity. No acute dietary risk

endpoint was identified by EPA, and is

not of concern in this risk assessment.

2. Chronic toxicity. EPA has

established the RfD for tebufenozide at

0.018 milligrams/kilogram/day (mg/kg/

day). This RfD is based on a 1–year

feeding study in dogs with a NOEL of

1.8 mg/kg/day. An uncertainty factor of

100 was used to account for both the

interspecies extrapolation and

intraspecies variability. The LEL of 8.7

mg/kg/day was based on hematopoietic

findings (decreased red blood cells,

hematocrit, hemoglobin levels, and

increased heinz bodies, MCV, MCH,

reticulocytes, and platelets).

3. Carcinogenicity. Tebufenozide has

been classified as a Group E, ‘‘no

evidence of carcinogenicity for

humans,’’ chemical by EPA.

B. Exposures and Risks

1. From food and feed uses.

Tolerances have been established (40

CFR 180.482) for the residues of

tebufenozide, in or on a variety of raw

agricultural commodities. The residue

of concern in sugarcane is the parent

compound, tebufenozide per se, as

specified in 40 CFR 180.482. A

permanent tolerance is established for

the residues of tebufenozide in/on

walnuts at 0.1 ppm and a time-limited

tolerance in/on peppers at 0.5 ppm. A

permanent tolerance at 1.0 ppm has also

previously been established for

imported apples. EPA has recently taken

actions to establish time-limited

tolerances in connection with section 18

uses on domestic apples (and timelimited tolerances on associated animal

commodities), on cottonseed at 0.2 ppm,

leafy vegetables (except Brassica) at 5.0

ppm, Brassica (cole) leafy vegetables at

5.0 ppm, sugar beets at 0.3 ppm, and

turnip tops at 5.0 ppm. Risk assessments

were conducted by EPA to assess

dietary exposures and risks from

tebufenozide 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. Since an

acute dietary endpoint has not been

identified in EPA’s toxicology database,

an assessment of acute dietary risk was

not conducted for this Section 18

request.

ii. Chronic exposure and risk. In

conducting this exposure assessment,

EPA has made very conservative

assumptions -- 100% of sugarcane and

all other commodities having

tebufenozide tolerances will contain

tebufenozide residues and those

residues would be at the level of the

tolerance -- which 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 existing

tebufenozide tolerances (published,

pending, and including the necessary

section 18 tolerances) result in a

Theoretical Maximum Residue

Contribution (TMRC) that is equivalent

to the following percentages of the RfD:

Population Subgroup TMRCfood (mg/kg/day) %RfD

U.S. Population - 48 States .................................................... 0.005516 ................................................................................ 31%

Nursing Infants (<1 year old) .................................................. 0.007384 ................................................................................ 41%

Non-Nursing Infants (<1 year old) .......................................... 0.014348 ................................................................................ 80%

Children (1–6 years old) ......................................................... 0.010646 ................................................................................ 59%

Children (7–12 years old) ....................................................... 0.007595 ................................................................................ 42%

Non-Hispanic Blacks .............................................................. 0.006063 ................................................................................ 34%

Non-Hispanic Others .............................................................. 0.007358 ................................................................................ 41%

Western Region ...................................................................... 0.006033 ................................................................................ 34%

The subgroups listed above are: (1)

the U.S. population (48 States); (2) those

for infants and children; and, (3) the

other subgroups for which the

percentage of the RfD occupied is

greater than that occupied by the

subgroup U.S. population (48 States).

For chronic dietary risk to

tebufenozide, the population subgroup

with the largest percentage of the RfD

occupied is non-nursing infants (<1 year

old) at 80% of the RfDs.

2. From drinking water. Submitted

environmental fate studies suggest that

tebufenozide is moderately persistent to

persistent and mobile; thus,

tebufenozide could potentially leach to

ground water and runoff to surface

water under certain environmental

conditions. There is no established

Maximum Contaminant Level (MCL) for

residues of tebufenozide in drinking

water. No drinking water Health

Advisories have been issued for

tebufenozide. There is no entry for

tebufenozide in the ‘‘Pesticides in

Groundwater Database’’ (EPA 734–12–

92–001, September 1992).

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
Federal Register / Vol. 62, No. 228 / Wednesday, November 26, 1997 / Rules and Regulations 62983

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 tebufenozide 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

tebufenozide 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.

Tebufenozide is not currently registered

for any indoor or outdoor residential

uses; therefore, no non-dietary

residential exposure is anticipated.

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

tebufenozide 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,

tebufenozide 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 tebufenozide has a

common mechanism of toxicity with

other substances.

C. Aggregate Risks and Determination of

Safety for U.S. Population

1. Chronic risk. Using the TMRC

exposure assumptions described above,

EPA has concluded that aggregate

exposure to tebufenozide from food will

utilize 31% of the RfD for the U.S.

population. The major identifiable

subgroup with the highest aggregate

exposure is infants or children, which is

discussed below. 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

tebufenozide in drinking water and from

non-dietary, non-occupational exposure,

EPA does not expect the aggregate

exposure to exceed 100% of the RfD.

Since there are no non-dietary nonoccupational exposure scenarios for

tebufenozide, there are no additional

exposure from those routes. EPA

concludes that there is a reasonable

certainty that no harm will result from

aggregate exposure to tebufenozide

residues.

2. Short- and intermediate-term risk.

Since there were no toxicity endpoints

identified by the TES Committee for

tebufenozide and no indoor/outdoor

residential uses, no short- or

intermediate-term risk assessment was

required.

D. Aggregate Cancer Risk for U.S.

Population

Since tebufenozide has been classified

as a Group E chemical, ‘‘no evidence of

carcinogenicity for humans,’’ no cancer

risk assessment was required.

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

tebufenozide, EPA considered data from

developmental toxicity studies in the rat

and rabbit and a two-generation

reproduction study in the rat. This is

generally the case -- edit if different

studies. 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.
62984 Federal Register / Vol. 62, No. 228 / Wednesday, November 26, 1997 / Rules and Regulations

ii. Developmental toxicity studies —

a. Rats. In the developmental toxicity

study in rats, the maternal (systemic)

NOEL was 250 mg/kg/day. The LOEL

was 1,000 mg/kg/day, based on

decreased body weight and food

consumption. The developmental (pup)

NOEL was >1,000 mg/kg/day (HDT).

b. Rabbits. In the developmental

toxicity study in rabbits, the maternal

and developmental NOELs were >1,000

mg/kg/day (HDT).

c. Pre-Natal Sensitivity. EPA has

concluded that the developmental

NOELs of >1,000 mg/kg/day (HDT) from

the developmental toxicity studies in

rats and rabbits demonstrate that there

is no developmental (prenatal) toxicity

present for tebufenozide. Additionally,

these developmental NOELs are greater

than 500-fold higher than the NOEL of

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

study in dogs which was the basis of the

RfD.

iii. Reproductive toxicity study —

Rats. In the multigeneration

reproductive toxicity study in rats, the

parental (systemic) NOEL was 0.85 mg/

kg/day. Splenic pigmentation changes

and extramedullary hematopoiesis

occurred at the LOEL of 12.1 mg/kg/day

(male, female; F0, F1). In addition to

these effects, decreased body weight

gain and food consumption occurred at

171.1 mg/kg/day. The reproductive

(pup) NOEL was 125 mg/kg/day. The

reproductive LOEL of 171.1 mg/kg/day,

based on a slight increase in the number

of pregnant females that either did not

deliver or had difficulty and had to be

sacrificed (F1). Additionally at the

LOEL, in F1 dams, the length of

gestation increased and implantation

sites decreased significantly. Finally,

the number of pups per litter decreased

on Lactation Day (LD) 4 to 90% of the

controls for the F1 and on LD’s 0 and 4

to 80% for the second generation.

iv. Pre- and post-natal sensitivity. In

the reproductive toxicity study in rats,

the reproductive NOEL (12.1 mg/kg/

day) is 14-fold higher than the parental

NOEL (0.85 mg/kg/day) and indicates

that post-natal toxicity in the

reproductive studies occurs only in the

presence of significant parental toxicity.

These developmental and reproductive

studies indicate that tebufenozide does

not have additional post-natal

sensitivity for infants and children in

comparison to other exposed groups.

2. Chronic risk. Using the

conservative exposure assumptions

described above, HED has concluded

that the percentage of the RfD that will

be utilized by dietary (food only)

exposure to residues of tebufenozide

ranges from 41% for nursing infants (<

1 year old) up to 80% for non-nursing

infants (< 1 year 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 tebufenozide in drinking

water and from non-dietary, nonoccupational exposure, 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 to infants and children

from aggregate exposure to tebufenozide

residues.

V. Other Considerations

A. Metabolism In Plants and Animals

The metabolism of tebufenozide in/on

plants is adequately understood. The

residue of concern is the parent

compound, tebufenozide per se, as

specified in 40 CFR 180.482.

The metabolism of tebufenozide in

animals is not adequately understood.

However, for the purpose of this section

18 exemption only, EPA considers the

residue of concern to be the parent

compound, tebufenozide per se.

B. Analytical Enforcement Methodology

The HPLC/UV analytical method, TR

34–94–38 is adequate to detect residues

of the parent compound in sugarcane to

support this section 18 request. There is

also an available extraction and GC/MS

confirmatory technique described in the

Rohm and Haas rice metabolism study.

There are no analytical methods

available to the Agency, at this time, to

detect secondary residues in animal

matrices likely as a result of the

proposed use.

C. Magnitude of Residues

Residues of tebufenozide per se are

not expected to exceed the following

levels as a result of this section 18 use:

Commodity Parts per million

sugarcane ................. 0.3

A time-limited tolerance for the

residues of tebufenozide per se should

be established at this level.

The summation of a sugarcane

processing study submitted with this

action indicates that residues of

tebufenozide do not concentrate in

sugarcane refined sugar (0.03x) or

molasses (1.1x). Thus, tolerances for the

residues of tebufenozide per se are not

needed on these commodities. However,

the following levels were used for the

DRES analysis which EPA performed:

Commodity Parts per million

sugar, refined ............ 0.01

sugar cane molasses 0.35

Based on the summary data provided,

residues of tebufenozide in ruminant

commodities (cattle, sheep, horse, and

goat) will not exceed the levels

established for the use of tebufenozide

on apples.

There are no poultry or swine feed

items associated with these uses;

consequently secondary residues of

tebufenozide are not expected in poultry

or swine commodities.

D. International Residue Limits

There are currently no CODEX,

Canadian, or Mexican listings for

tebufenozide residues, therefore there

are no harmonization issues for this

action.

E. Rotational Crop Restrictions

Sugarcane is not rotated to other

crops, therefore a discussion of

rotational crop restrictions is not

germane to this action.

VI. Conclusion

Therefore, the tolerance is established

for residues of tebufenozide in

sugarcane at 0.3 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
Federal Register / Vol. 62, No. 228 / Wednesday, November 26, 1997 / Rules and Regulations 62985

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–300567] (including any

comments and data submitted

electronically). A public version of this

record, including printed, paper

versions of electronic comments, which

does not include any information

claimed as CBI, is available for

inspection from 8:30 a.m. to 4 p.m.,

Monday through Friday, excluding legal

holidays. The public record is located in

Room 1132 of the Public Information

and Records Integrity Branch,

Information Resources and Services

Division (7502C), Office of Pesticide

Programs, Environmental Protection

Agency, CM #2, 1921 Jefferson Davis

Hwy., 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 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 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 acations 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: November 10, 1997.

James Jones,

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. In § 180.482(b), by adding

alphabetically the following entry to the

table:

§ 180.482 Tebufenozide; tolerances for

residues.

* * * * *

(b)* * *

Commodity Parts per million Expiration/Revocation Date

* * * * *

Sugarcane ........................................................................................... 0.03 December 31, 1998

* * * * *
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