Federal Register / Vol. 66, No. 96 / Thursday, May 17, 2001 / Rules and Regulations 27463

EPA–APPROVED REGULATIONS IN THE DELAWARE SIP

State citation Title/subject State effective date EPA approval date Comments

*******

Regulation 39—Nitrogen Oxides (NOX) Budget Trading Program

Section 1 ............................ Purpose ................................................... 12/11/00 5/17/01 Federal Register

cite.

[Use this section as necessary to explain exceptions or limitations]

Section 2 ............................ Emission Limitation ................................. 12/11/00

Section 3 ............................ Applicability ............................................. 12/11/00

Section 4 ............................ Definitions ................................................ 12/11/00

Section 5 ............................ General Provisions .................................. 12/11/00

Section 6 ............................ NOX Authorized Account Representative

for NOX Budget Sources.

12/11/00

Section 7 ............................ Permits .................................................... 12/11/00

Section 8 ............................ Monitoring and Reporting ........................ 12/11/00

Section 9 ............................ NATS ....................................................... 12/11/00

Section 10 .......................... NOX Allowance Transfers ....................... 12/11/00

Section 11 .......................... Compliance Certification ......................... 12/11/00

Section 12 .......................... End-of-Season Reconciliation ................. 12/11/00

Section 13 .......................... Failure to Meet Compliance Requirements.12/11/00

Section 14 .......................... Individual Unit Opt-Ins ............................. 12/11/00

Section 15 .......................... General Accounts .................................... 12/11/00

Appendix ‘‘A’’ ...................... Allowance Allocations to NOX Budget

Units.

12/11/00

Appendix ‘‘B’’ ...................... Regulation No. 37—Regulation No. 39

Program Transition.

12/11/00

*******

[FR Doc. 01–12351 Filed 5–16–01; 8:45 am]

BILLING CODE 6560–50–P

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Part 180

[OPP–301126; FRL–6781–8]

RIN 2070–AB78

Cyfluthrin; Pesticide Tolerances for

Emergency Exemptions

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Final rule.

SUMMARY: This regulation establishes

time-limited tolerances for residues of

cyfluthrin in or on grapes and raisins;

grain of barley, oats, and wheat; and fat

of cattle, goats, hogs, horses and sheep.

This action is in response to EPA’s

granting of emergency exemptions

under section 18 of the Federal

Insecticide, Fungicide, and Rodenticide

Act authorizing use of the pesticide on

grapes and stored grain. This regulation

establishes maximum permissible levels

for residues of cyfluthrin in these food

commodities. These tolerances will

expire and are revoked on June 30,

2003.

DATES: This regulation is effective May

17, 2001. Objections and requests for

hearings, identified by docket control

number OPP–301126, must be received

by EPA on or before July 16, 2001.

ADDRESSES: Written objections and

hearing requests may be submitted by

mail, in person, or by courier. Please

follow the detailed instructions for each

method as provided in Unit VII. of the

SUPPLEMENTARY INFORMATION. To ensure

proper receipt by EPA, your objections

and hearing requests must identify

docket control number OPP–301126 in

the subject line on the first page of your

response.

FOR FURTHER INFORMATION CONTACT: By

mail: Stephen Schaible, Registration

Division (7505C), Office of Pesticide

Programs, Environmental Protection

Agency, 1200 Pennsylvania Ave., NW.,

Washington, DC 20460; telephone

number: 703–308–9362; and e-mail

address: schaible.stephen@epa.gov.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

You may be potentially affected by

this action if you are an agricultural

producer, food manufacturer, or

pesticide manufacturer. Potentially

affected categories and entities may

include, but are not limited to:

Categories NAICS Examples of Potentially Affected Entities

Industry 111 Crop production

112 Animal production

311 Food manufacturing

32532 Pesticide manufacturing

This listing is not intended to be

exhaustive, but rather provides a guide

for readers regarding entities likely to be

affected by this action. Other types of

entities not listed in the table could also

be affected. The North American

Industrial Classification System

(NAICS) codes have been provided to

assist you and others in determining

whether or not this action might apply

to certain entities. If you have questions

regarding the applicability of this action

to a particular entity, consult the person

listed under FOR FURTHER INFORMATION

CONTACT.

B. How Can I Get Additional

Information, Including Copies of This

Document and Other Related

Documents?

1. Electronically.You may obtain

electronic copies of this document, and

certain other related documents that

27464 Federal Register / Vol. 66, No. 96 / Thursday, May 17, 2001 / Rules and Regulations

might be available electronically,from

the EPA Internet Home Page at http://

www.epa.gov. To access this document,

on the Home Page select ‘‘Laws and

Regulations,’’ ‘‘Regulations and

Proposed Rules,’’ and then look up the

entry for this document under the

‘‘Federal Register—Environmental

Documents.’’ You can also go directly to

theFederal Register listings at http://

www.epa.gov/fedrgstr/. To access the

OPPTS Harmonized Guidelines

referenced in this document, go directly

to the guidelines at http://www.epa.gov/

opptsfrs/home/guidelin.htm. A

frequently updated electronic version of

40 CFR part 180 is available at http://

www.access.gpo.gov/nara/cfr/

cfrhtml_180/Title_40/40cfr180_00.html,

a beta site currently under development.

2.In person. The Agency has

established an official record for this

action under docket control number

OPP–301126. The official record

consists of the documents specifically

referenced in this action, and other

information related to this action,

including any information claimed as

Confidential Business Information (CBI).

This official record includes the

documents that are physically located in

the docket, as well as the documents

that are referenced in those documents.

The public version of the official record

does not include any information

claimed as CBI. The public version of

the official record, which includes

printed, paper versions of any electronic

comments submitted during an

applicable comment period is available

for inspection in the Public Information

and Records Integrity Branch (PIRIB),

Rm. 119, Crystal Mall #2, 1921 Jefferson

Davis Hwy., Arlington, VA, from 8:30

a.m. to 4 p.m., Monday through Friday,

excluding legal holidays. The PIRIB

telephone number is (703) 305–5805.

II. Background and Statutory Findings

EPA, on its own initiative, in

accordance with sections 408(e) and

408(l)(6) of the Federal Food, Drug, and

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

is establishing tolerances for residues of

the insecticide cyfluthrin, cyano[4-

fluoro-3-phenoxyphenyl]-methyl-3-[2,2-

dichloroethenyl]-2,2-dimethylcyclopropanecarboxylate, in or on grape

at 1.0 part per million (ppm); grape,

raisin at 1.5 ppm; grain of barley, oats,

and wheat at 2.0 ppm; and fat of cattle,

goats, hogs, horses and sheep at 6.0

ppm. These tolerances will expire and

are revoked on June 30, 2003. EPA will

publish a document in the Federal

Register to remove the revoked

tolerances from the Code of Federal

Regulations.

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. EPA does not intend for its

actions on section 18 related tolerances

to set binding precedents for the

application of section 408 and the new

safety standard to other tolerances and

exemptions. Section 408(e) of the

FFDCA allows EPA to establish a

tolerance or an exemption from the

requirement of a tolerance on its own

initiative, i.e., without having received

any petition from an outside party.

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 the Federal Insecticide,

Fungicide, and Rodenticide Act (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 the Food

Quality Protection Act (FQPA). EPA has

established regulations governing such

emergency exemptions in 40 CFR part

166.

III. Emergency Exemptions for

Cyfluthrin on Grapes and Stored

Grains and FFDCA Tolerances

According to the South Dakota

Department of Agriculture, reports of

damage to stored grain from infestations

of lesser grain borer have increased in

recent years. Lesser grain borer is a

serious pest of stored grain because it is

capable of destroying whole, sound

grain. Storage of grain in larger, less

protective structures have caused grain

to be more vulnerable to infestations,

primarily because the grain remains

warmer, creating conditions favorable to

insect development. The Applicant

claims that there are not currently any

effective registered alternatives for

control of lesser grain borer. Reldan 4E

(chlorpyrifos-methyl) is registered for

use on wheat and sorghum but will not

control lesser grain borer. Most

malathion uses are no longer available,

but even if they were insect resistance

has built up to the point that this

chemical is not effective. Phosphine gas

is the primary fumigant of stored grain,

but lesser grain borer has begun to

demonstrate resistance. Storcide is a

combination product containing the

active ingredients chlorpyrifos-methyl

and cyfluthrin; while the chlorpyrifosmethyl component of this product

controls most insect pests in stored

grain, the cyfluthrin component is

necessary to control the lesser grain

borer. The Applicant predicts that

without the proposed use of Storcide,

between 33% and 50% of bushels could

be affected, resulting in $13.3 million in

economic losses.

The California Department of

Pesticide Regulation states that glassy

winged sharpshooters are a recently

introduced pest of grape production,

and serve as a vector of Pierce’s disease,

which is caused by the bacterium

Xylella fastidiosa. This disease can

destroy a vineyard within 12 months

and can still kill vines 2 to 3 years after

infection. Since 1998, growers have

observed a 25–30% reduction in vines,

with 80% of some vineyard blocks being

removed due to the disease. This same

infection process and bacterium are the

causal agents for other plant diseases in

peaches in the southeastern United

States and citrus in Brazil.

The required feeding time necessary

for the pest to successfully vector

bacterium for Pierce’s disease is not

known as of yet. Therefore, rapid

control of the glassy winged

sharpshooter may be essential to avoid

significant economic losses. Given this,

the Applicant claims that the available

alternatives, imidacloprid and

dimethoate, are not sufficient to provide

control of this pest throughout the 7–

month period of occurrence in

California vineyards. While

imidacloprid may provide some control

of this pest, the soil applied formulation

is slow acting and the foliar formulation

has little persistence (thus making

multiple applications necessary). The

pre-harvest interval for dimethoate

makes it impractical for use in grapes.

Because of its rapid population advance

Federal Register / Vol. 66, No. 96 / Thursday, May 17, 2001 / Rules and Regulations 27465

and ability to vector problem plant

diseases, glassy-winged sharpshooter is

now considered to be a significant threat

to California’s $2.8 billion/year wine,

raisin, table grape and citrus industries.

The California Department of Food and

Agriculture (CDFA) maintains that

Pierce’s disease is responsible for $12

million in losses of grapevines in

Temecula, California.

EPA has authorized under FIFRA

section 18 the uses of cyfluthrin on

grapes for control of glassy winged

sharpshooter in California and on stored

grain in South Dakota for control of

lesser grain borer and other insect pests.

After having reviewed these

submissions, EPA concurs that

emergency conditions exist for these

States.

As part of its assessment of these

emergency exemptions, EPA assessed

the potential risks presented by residues

of cyfluthrin in or on grapes, raisins,

and grain, and by secondary residues of

cyfluthrin in animal commodities as a

result of treated grain commodities

being used as feed items. In doing so,

EPA considered the safety standard in

FFDCA section 408(b)(2), and EPA

decided that the necessary tolerances

under FFDCA section 408(l)(6) would be

consistent with the safety standard and

with FIFRA section 18. Consistent with

the need to move quickly on the

emergency exemptions in order to

address urgent non-routine situations

and to ensure that the resulting food is

safe and lawful, EPA is issuing these

tolerances without notice and

opportunity for public comment as

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

these tolerances will expire and are

revoked on June 30, 2003, under FFDCA

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

pesticide not in excess of the amounts

specified in the tolerances remaining in

or on grapes and raisins; grain of barley,

oats, and wheat; and fat of cattle, goats,

hogs, horses and sheep after that date

will not be unlawful, provided the

pesticide is applied in a manner that

was lawful under FIFRA, and the

residues do not exceed the levels that

were authorized by these tolerances at

the time of those applications. EPA will

take action to revoke these tolerances

earlier if any experience with, scientific

data on, or other relevant information

on this pesticide indicate that the

residues are not safe.

Because these tolerances are being

approved under emergency conditions,

EPA has not made any decisions about

whether cyfluthrin meets EPA’s

registration requirements for use on

grapes or stored grain or whether

permanent tolerances for these uses

would be appropriate. Under these

circumstances, EPA does not believe

that these tolerances serve as a basis for

registration of cyfluthrin by a State for

special local needs under FIFRA section

24(c). Nor do these tolerances serve as

the basis for any State other than

California or South Dakota to use this

pesticide on these crops under section

18 of FIFRA without following all

provisions of EPA’s regulations

implementing section 18 as identified in

40 CFR part 166. For additional

information regarding the emergency

exemptions for cyfluthrin, contact the

Agency’s Registration Division at the

address provided under FOR FURTHER

INFORMATION CONTACT.

IV. Aggregate Risk Assessment and

Determination of Safety

EPA performs a number of analyses to

determine the risks from aggregate

exposure to pesticide residues. For

further discussion of the regulatory

requirements of section 408 and a

complete description of the risk

assessment process, see the final rule on

Bifenthrin Pesticide Tolerances (62 FR

62961, November 26, 1997) (FRL–5754–

7) .

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 cyfluthrin and to make a

determination on aggregate exposure,

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

time-limited tolerances for residues of

cyfluthrin in or on grape at 1.0 ppm;

grape, raisin at 1.5 ppm; grain of barley,

oats and wheat at 2.0 ppm; and fat of

cattle, goat, hogs, horses and sheep at

6.0 ppm. EPA’s assessment of the

dietary exposures and risks associated

with establishing these tolerances

follows.

A. Toxicological Endpoints

The dose at which no adverse effects

are observed (the NOAEL) from the

toxicology study identified as

appropriate for use in risk assessment is

used to estimate the toxicological

endpoint. However, the lowest dose at

which adverse effects of concern are

identified (the LOAEL) is sometimes

used for risk assessment if no NOAEL

was achieved in the toxicology study

selected. An uncertainty factor (UF) is

applied to reflect uncertainties inherent

in the extrapolation from laboratory

animal data to humans and in the

variations in sensitivity among members

of the human population as well as

other unknowns. An UF of 100 is

routinely used, 10X to account for

interspecies differences and 10X for

intraspecies differences.

For dietary risk assessment (other

than cancer) the Agency uses the UF to

calculate an acute or chronic reference

dose (acute RfD or chronic RfD) where

the RfD is equal to the NOAEL divided

by the appropriate UF (RfD = NOAEL/

UF). Where an additional safety factor is

retained due to concerns unique to the

FQPA, this additional factor is applied

to the RfD by dividing the RfD by such

additional factor. The acute or chronic

Population Adjusted Dose (aPAD or

cPAD) is a modification of the RfD to

accommodate this type of FQPA Safety

Factor.

For non-dietary risk assessments

(other than cancer) the UF is used to

determine the level of concern (LOC).

For example, when 100 is the

appropriate UF (10X to account for

interspecies differences and 10X for

intraspecies differences) the LOC is 100.

To estimate risk, a ratio of the NOAEL

to exposures (margin of exposure (MOE)

= NOAEL/exposure) is calculated and

compared to the LOC.

The linear default risk methodology

(Q*) is the primary method currently

used by the Agency to quantify

carcinogenic risk. The Q* approach

assumes that any amount of exposure

will lead to some degree of cancer risk.

A Q* is calculated and used to estimate

risk which represents a probability of

occurrence of additional cancer cases

(e.g., risk is expressed as 1 x 10∆6or one

in a million). Under certain specific

circumstances, MOE calculations will

be used for the carcinogenic risk

assessment. In this non-linear approach,

a ‘‘point of departure’’ is identified

below which carcinogenic effects are

not expected. The point of departure is

typically a NOAEL based on an

endpoint related to cancer effects

though it may be a different value

derived from the dose response curve.

To estimate risk, a ratio of the point of

departure to exposure (MOEcancer = point

of departure/exposures) is calculated. A

summary of the toxicological endpoints

for cyfluthrin used for human risk

assessment is shown in the following

Table 1:

27466 Federal Register / Vol. 66, No. 96 / Thursday, May 17, 2001 / Rules and Regulations

TABLE 1.—SUMMARY OF TOXICOLOGICAL DOSE AND ENDPOINTS FOR CYFLUTHRIN FOR USE IN HUMAN RISK ASSESSMENT

Exposure Scenario Dose (mg/kg bwt/day) Endpoint Study

Acute Dietary (All population) Developmental NOAEL =

20.0; LOAEL = 60.0

Increased numbers of resorption and percent incidence of postimplantation

loss in rabbits in a developmental toxicity study.

Developmental - rabbit (oral)

UF=300 (10x inter- and 10x

intra- and 3x FQPA considerations)

Acute Population Adjusted

Dose (aPAD)aPAD =

NOAEL/UF= 20/300 =

0.07 mg/kg bwt/day

Chronic Dietary NOAEL = 2.5; LOAEL = 6.2 Decreased body weight

gain in males, and inflammatory foci in kidneys of

female rats in a chronic

toxicity/ carcinogenicity

study.

2-year rat (oral)

UF = 300: 10X inter- and

10X intra and 3x FQPA

factor for all population

subgroups

Chronic Population Adjusted

Dose (cPAD) cPAD =

NOAEL/UF = 2.5/300 =

0.008 mg/kg bwt/day

Short, intermediate-Term (1–7

days) Occupational/Residential

Dermal NOAEL =20.0;

LOAEL =60.0 (Dermal absorption rate = 25%)

Increased numbers of resorption and percent incidence of postimplantation

loss in rabbits.

Developmental - rabbit (oral)

MOE = 300

Intermediate-Term (one week to

several months) Occupational/

Residential

Dermal NOAEL = 20.0;

LOAEL = 60.0 (Dermal

absorption rate = 25%)

Increased numbers of resorption and percent incidence of postimplantation

loss in rabbits. MOE =

300

Developmental - rabbit (oral)

Long-Term Dermal NOAEL = 2.5;

NOAEL = 6.2 (Systemic)

Dermal absorption rate =

25%

Decreased body weight in

male and inflammatory

foci in the kidney of female rats in a chronic

toxicity/ carcinogenicity

study. MOE=300

2–year rat (oral)

All time periods Inhalation: Short-Term:

NOAEL = 0.44 μg/L =

0.12 mg/kg/day;LOAEL=6

μg/L

Decreases in body and thymus weights, hypothermia

and clinical pathology in

rats in a 28–day study

(short-term) and behavioral effects in rats in a

90–day study

(intermediate/ chronic).

UF = 300

28–day rat inhalation study (short-term)

Intermediate/Chronic:

NOAEL = 0.09 μg/L =

0.024 mg/kg/

day;LOAEL=0.7 μg/L

The extrapolation method

was used in converting

the NOAEL from μg/L to

mg/kg/day

90-day rat inhalation study (intermediate/chronic)

Cancer Oral Cyfluthrin is classified as a

group E chemical. Carcinogenicity studies in

rats and mice were negative.

* The reference to the FQPA Safety Factor refers to any additional safety factor retained due to concerns unique to the FQPA.

B. Exposure Assessment

1. Dietary exposure from food and

feed uses. Tolerances have been

established (40 CFR 180.436) for the

residues of cyfluthrin, in or on a variety

of raw agricultural commodities.

Existing tolerances for aspirated grain

fractions (300 ppm), sorghum, grain (4

ppm); and meat and meat byproducts of

cattle, goats, hogs, horses, and sheep

(0.4 ppm for both meat and meat

byproducts) are sufficient to cover

residues resulting from the application

of cyfluthrin under the emergency

Federal Register / Vol. 66, No. 96 / Thursday, May 17, 2001 / Rules and Regulations 27467

exemption. The existing tolerance of 5.0

ppm for fat of cattle, goats, hogs, horses,

and sheep is insufficient to cover

residues resulting from section 18 use

on stored grains; the time-limited

tolerance of 6.0 ppm is therefore being

established. While time-limited

tolerances of 1.0 ppm for grapes and 1.5

ppm for raisins are required, no

concentration of residues occurs in

grape juice and a separate tolerance for

that commodity is not required. For

purposes of dietary risk assessment,

residue data generated from residue

field trials conducted at maximum

application rate and minimum

preharvest intervals were used, as were

processing data for grapes. To assess

secondary exposure from edible animal

commodities, animal dietary burdens

were calculated using mean field trial

residues, adjusted to take into account

percent of crop treated information, and

applying appropriate processing factors

for all feed items. Risk assessments were

conducted by EPA to assess dietary

exposures from cyfluthrin in food as

follows:

i. Acute exposure. Acute dietary risk

assessments are performed for a fooduse 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 Dietary

Exposure Evaluation Model (DEEM)

analysis evaluated the individual food

consumption as reported by

respondents in the USDA 1989–1992

nationwide Continuing Surveys of Food

Intake by Individuals (CSFII) and

accumulated exposure to the chemical

for each commodity. The following

assumptions were made for the acute

exposure assessments: anticipated

residues and percent of crop treated

refinements were used for existing

tolerances; anticipated residues and

100% of crop treated were assumed for

the proposed tolerances associated with

section 18 uses on stored grains and

grapes. Anticipated residues were also

assumed for meat, milk, poultry and egg

tolerances. This Tier 3 Monte Carlo

analysis is considered partially to highly

refined. Field trial residue distributions

were assumed for those foods identified

by EPA as single-serving commodities.

For those foods considered to be

blended or processed, mean field trial

residues were calculated, substituting

the full limit of detection (LOD) for

those samples for which residues were

reported below the LOD.

ii. Chronic exposure. In conducting

this chronic dietary risk assessment the

DEEM analysis evaluated the

individual food consumption as

reported by respondents in the USDA

1989–1992 nationwide CSFII and

accumulated exposure to the chemical

for each commodity. The following

assumptions were made for the chronic

exposure assessments: field trial

residues and percent of crop treated

refinements were used for the existing

tolerances; anticipated residues and

100% of crop treated were assumed for

the section 18 uses on stored grains and

grapes. Anticipated residues were also

assumed for meat, milk, poultry and egg

tolerances. This Tier 3 analysis is

considered partially to highly refined.

iii. Cancer. Cyfluthrin has been

classified as a not likely human

carcinogen (Group E chemical). A

cancer dietary risk assessment is not

required.

iv. Anticipated residue and percent

crop treated information. Section

408(b)(2)(E) authorizes EPA to use

available data and information on the

anticipated residue levels of pesticide

residues in food and the actual levels of

pesticide chemicals that have been

measured in food. If EPA relies on such

information, EPA must require that data

be provided 5 years after the tolerance

is established, modified, or left in effect,

demonstrating that the levels in food are

not above the levels anticipated.

Following the initial data submission,

EPA is authorized to require similar

data on a time frame it deems

appropriate. As required by section

408(b)(2)(E), EPA will issue a data callin for information relating to anticipated

residues to be submitted no later than 5

years from the date of issuance of this

tolerance.

Section 408(b)(2)(F) states that the

Agency may use data on the actual

percent of food treated for assessing

chronic dietary risk only if the Agency

can make the following findings:

Condition 1, that the data used are

reliable and provide a valid basis to

show what percentage of the food

derived from such crop is likely to

contain such pesticide residue;

Condition 2, that the exposure estimate

does not underestimate exposure for any

significant subpopulation group; and

Condition 3, if data are available on

pesticide use and food consumption in

a particular area, the exposure estimate

does not understate exposure for the

population in such area. In addition, the

Agency must provide for periodic

evaluation of any estimates used. To

provide for the periodic evaluation of

the estimate of percent crop treated

(PCT) as required by section

408(b)(2)(F), EPA may require

registrants to submit data on PCT.

The Agency used percent crop treated

(PCT) information as shown in the

following Table 2:

TABLE 2.—PERCENT OF CROP TREATED ESTIMATES FOR ACUTE AND

CHRONIC RISK ASSESSMENT

Site

Percent of Crop Treated

Weighted

Average

(Chronic)

Estimated

Maximum

(Acute)

Corn 1 3

Alfalfa 1 1

Orange 5 13

Sorghum 1 1

Sweet Corn 3 6

Tomato 3 5

The Agency believes that the three

conditions listed above have been met.

With respect to Condition 1, PCT

estimates are derived from Federal and

private market survey data, which are

reliable and have a valid basis. EPA uses

a weighted average PCT for chronic

dietary exposure estimates. This

weighted average PCT figure is derived

by averaging State-level data for a

period of up to 10 years, and weighting

for the more robust and recent data. A

weighted average of the PCT reasonably

represents a person’s dietary exposure

over a lifetime, and is unlikely to

underestimate exposure to an individual

because of the fact that pesticide use

patterns (both regionally and nationally)

tend to change continuously over time,

such that an individual is unlikely to be

exposed to more than the average PCT

over a lifetime. For acute dietary

exposure estimates, EPA uses an

estimated maximum PCT. The exposure

estimates resulting from this approach

reasonably represent the highest levels

to which an individual could be

exposed, and are unlikely to

underestimate an individual’s acute

dietary exposure. The Agency is

reasonably certain that the percentage of

the food treated is not likely to be an

underestimation. As to Conditions 2 and

3, regional consumption information

and consumption information for

significant subpopulations is taken into

account through EPA’s computer-based

model for evaluating the exposure of

significant subpopulations including

several regional groups. Use of this

consumption information in EPA’s risk

assessment process ensures that EPA’s

exposure estimate does not understate

exposure for any significant

subpopulation group and allows the

Agency to be reasonably certain that no

regional population is exposed to

residue levels higher than those

estimated by the Agency. Other than the

27468 Federal Register / Vol. 66, No. 96 / Thursday, May 17, 2001 / Rules and Regulations

data available through national food

consumption surveys, EPA does not

have available information on the

regional consumption of food to which

cyfluthrin may be applied in a

particular area.

2. Dietary exposure from drinking

water. The Agency lacks sufficient

monitoring exposure data to complete a

comprehensive dietary exposure

analysis and risk assessment for

cyfluthrin in drinking water. Because

the Agency does not have

comprehensive monitoring data,

drinking water concentration estimates

are made by reliance on simulation or

modeling taking into account data on

the physical characteristics of

cyfluthrin. Cyfluthrin is poorly mobile

and moderately persistent, and will

remain sorbed to the soil for weeks

following treatment. This suggests little

potential to leach and contaminate

groundwater, but high potential for

transport to surface water via particulate

run-off during rain events.

The Agency uses the Generic

Estimated Environmental Concentration

(GENEEC) or the Pesticide Root Zone/

Exposure Analysis Modeling System

(PRZM/EXAMS) to estimate pesticide

concentrations in surface water and SCIGROW, which predicts pesticide

concentrations in groundwater. In

general, EPA will use GENEEC (a tier 1

model) before using PRZM/EXAMS (a

tier 2 model) for a screening-level

assessment for surface water. The

GENEEC model is a subset of the PRZM/

EXAMS model that uses a specific highend runoff scenario for pesticides.

GENEEC incorporates a farm pond

scenario, while PRZM/EXAMS

incorporate an index reservoir

environment in place of the previous

pond scenario. The PRZM/EXAMS

model includes a percent crop area

factor as an adjustment to account for

the maximum percent crop coverage

within a watershed or drainage basin.

None of these models include

consideration of the impact processing

(mixing, dilution, or treatment) of raw

water for distribution as drinking water

would likely have on the removal of

pesticides from the source water. The

primary use of these models by the

Agency at this stage is to provide a

coarse screen for sorting out pesticides

for which it is highly unlikely that

drinking water concentrations would

ever exceed human health levels of

concern.

Since the models used are considered

to be screening tools in the risk

assessment process, the Agency does

not use estimated environmental

concentrations (EECs) from these

models to quantify drinking water

exposure and risk as a %RfD or %PAD.

Instead, drinking water levels of

comparison (DWLOCs) are calculated

and used as a point of comparison

against the model estimates of a

pesticide’s concentration in water.

DWLOCs are theoretical upper limits on

a pesticide’s concentration in drinking

water in light of total aggregate exposure

to a pesticide in food, and from

residential uses. Since DWLOCs address

total aggregate exposure to cyfluthrin

they are further discussed in the

aggregate risk sections below.

Based on the PRZM/EXAMS and SCIGROW models the estimated

environmental concentrations (EECs) of

cyfluthrin for acute exposures are

estimated to be 5.49 parts per billion

(ppb) for surface water and 0.006 ppb

for ground water. The EECs for chronic

exposures are estimated to be 2.18 ppb

for surface water and 0.006 ppb for

ground water. Because the Tier II

PRZM/EXAMS exposure estimates

exceed the solubility of cyfluthrin in

water, EPA used the value of 1.2 ppb,

the solubility of cyfluthrin in water, as

the acute and chronic EEC for the

surface water drinking water

assessment. This value represents that

maximum concentration of cyfluthrin

that would be found in surface water.

3. From non-dietary exposure. The

term ‘‘residential exposure’’ is used in

this document to refer to nonoccupational, non-dietary exposure

(e.g., for lawn and garden pest control,

indoor pest control, termiticides, and

flea and tick control on pets).

Cyfluthrin is currently registered for

use on the following residential nondietary sites: residential lawn and

gardens, inside households, carpets, and

as a termiticide. The termite control is

achieved by establishing a continuous

chemical barrier between the wood and

the termite colonies in the soil. Like

many other termite control chemicals,

cyfluthrin is normally applied to the

entire surface of soil or other substrate

to be covered by the slab before the

construction, or applied under the slab

after the construction. The potential of

dermal exposure is not expected.

However, some termite control

chemicals applied to the soil may

penetrate house foundation to become a

source for emission inside of the house.

Consequently, short-term and

intermediate-term as well as chronic

exposures via inhalation route may

occur. However, the vapor pressure of

cyfluthrin is 3.3 × 10 E-8 Torr which

indicates that the amount of emission

from this chemical is extremely limited.

For this reason, the potential of

inhalation exposure is also very limited.

Based on these considerations,

residential risk assessment was not

conducted for the termiticide use.

As mentioned above, cyfluthrin is

also registered for use on residential

lawns and carpets (fogger). Under

current Office of Pesticide Programs’

(OPP) guidelines, these uses do not

present a chronic exposure scenario;

because exposure to cyfluthrin may

occur as a result of inhalation or contact

from indoor and outdoor uses, these

uses do constitute a short- and/or

intermediate-term exposure scenario. A

residential exposure assessment for

those uses of cyfluthrin was conducted

in conjunction with the EPA’s risk

assessment supporting the extension of

tolerances for synthetic pyrethroids. The

exposure data (in mg/kg/day) from this

assessment are summarized in the

following tables 3 and 4:

TABLE 3.—EXPOSURE ASSESSMENT DATA FROM CYFLUTHRIN USE ON LAWNS

Scenario Individual Inhalation Dermal Oral

Lawn Application Adult not conducted not conducted not conducted

Post-Application Lawn Adult 1.16E-05 1.39E-03 not conducted

Post-Application Lawn Child (1–6) 2.78E-05 2.63E-03 2.85E-04

Post-Application Lawn Infant (<1) 3.56E-05 2.72E-03 3.03E-04

This product for lawns is a restricted

use pesticide, and therefore, required to

be applied by professional lawn care

operators only. Thus, from the

applicator perspective, this lawn

scenario is considered out of EPA’s

Federal Register / Vol. 66, No. 96 / Thursday, May 17, 2001 / Rules and Regulations 27469

scope for purposes of residential

exposure.

TABLE 4.—EXPOSURE ASSESSMENT DATA FROM CYFLUTHRIN USE ON CARPET

Scenario Individual Inhalation Dermal Oral

Carpet (fogger) Application Adult not conducted 8.84E-03 not conducted

Post-Application Carpet Adult 3.40E-05 1.63E-03 not conducted

Post-Application Carpet Child (1-6) 8.56E-06 4.20E-03 3.60E-04

Post-Application Carpet Infant (<1) 1.04E-05 4.65E-03 3.84E-04

4. Cumulative exposure to substances

with a 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.’’

EPA does not have, at this time,

available data to determine whether

cyfluthrin 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,

cyfluthrin 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 cyfluthrin has a common

mechanism of toxicity with other

substances. For information regarding

EPA’s efforts to determine which

chemicals have a common mechanism

of toxicity and to evaluate the

cumulative effects of such chemicals,

see the final rule for Bifenthrin Pesticide

Tolerances (62 FR 62961, November 26,

1997).

C. Safety Factor for Infants and Children

1. Safety factor for infants and

children—-i. In general. 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 prenatal

and postnatal toxicity and the

completeness of the database on toxicity

and exposure 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 margin of exposure (MOE) analysis

or through using uncertainty (safety)

factors in calculating a dose level that

poses no appreciable risk to humans.

ii. Developmental toxicity studies. In

the rat developmental study, neither a

maternal LOAEL nor a developmental

LOAEL was observed. The maternal

NOAEL was >10 mg/kg/day (the highest

dose tested), as was the developmental

NOAEL. The previously conducted

range finding study supported the dose

selection which was used in the

developmental study, and the rat study

is classified as an Acceptable guideline.

In the rabbit developmental study, the

maternal LOAEL was 60 mg/kg/day,

based on decreased body weight gain

and food consumption during the

dosing period. The maternal NOAEL

was 20 mg/kg/day. The developmental

LOAEL was 60 mg/kg/day, based on

increased numbers of resorptions and

percent incidence of postimplantation

loss. The developmental NOAEL is 20

mg/kg/day.

Two rat developmental toxicity

studies via the inhalation route of

exposure were also conducted. In the

first study, maternal effects were

observed at 4.7 mg/M3 and above, and

effects in the pups were observed at 1.1

mg/M3 and above. At 1.1 mg/M3 and

above, a dose-related increase in the

incidence of runts and skeletal

anomalies in the sternum were

observed. At 4.7 mg/M3 and above,

increases in post-implantation losses

and decreases in pup weights were

observed. At 23.7 mg/M3, increased

incidences of late embryonic deaths and

in skeletal anomalies in the extremities,

pelvis and skull were observed as well

as microphthalmia. The maternal

NOAEL is 1.1 mg/M3 and the maternal

LOAEL is 4.7 mg/M3, based on reduced

motility, dyspnea, piloerection,

ungroomed coats and eye irritation. The

developmental NOAEL is 0.59 mg/M3

and the developmental LOAEL is 1.1

mg/M3, based on increases in the

incidence of runts and skeletal

anomalies in the sternum (1.1 mg/M3

and above), increases in postimplantation losses and decreases in

pup weights (4.7 mg/M3 and above), and

increased incidences of late embryonic

deaths, in skeletal anomalies in the

extremities, pelvis and skull and in

microphthalmia (23.7 mg/M3).

In the second study, the maternal

NOAEL and LOAEL were < 0.46 mg/M3,

based on decreased body weight gain

and reduced relative food efficiency.

The developmental NOAEL was 0.46

mg/M3 and the developmental LOAEL

was 2.55 mg/M3, based on reduced fetal

and placental weight, and reduced

ossification in the phalanx, metacarpals,

and vertebrae.

iii. Reproductive toxicity study. In the

3-generation rat reproduction study, the

LOAEL for parental toxicity was 22.5

mg/kg/day, based on decreased body

weight gains; the NOAEL was 7.5 mg/

kg/day. The LOAEL for reproductive

toxicity was 7.5 mg/kg/day based on

decreased viability and lactational

indices and decreased pup body weight

gains. The NOAEL was 2.5 mg/kg/day.

iv. Prenatal and postnatal sensitivity.

There are no data gaps for reproductive

and developmental toxicity studies.

Evidence of increased sensitivity of

young rats following pre- and/or postnatal exposure to cyfluthrin was

observed in the three-generation

reproduction study in rats. There was

suggestive sensitivity of rats to in utero

exposure based on bradypnea seen in

dams in the developmental inhalation

studies. In addition, the reproductive

NOAEL of 2.5 mg/kg/day and the

LOAEL of 7.5 mg/kg/day established in

the three-generation reproduction study

in rats are identical to the systemic

NOAEL/LOAEL of 2.5/7.5 mg/kg/day

established in the chronic toxicity/

carcinogenicity study in rats. This

NOAEL (2.5 mg/kg/day) and a UF of 100

was used in deriving the RfD (0.025 mg/

kg/day) and the RfD does not provide

protection for infants and children.

v. Conclusion. There is a complete

toxicity database for cyfluthrin and

exposure data are complete or are

estimated based on data that reasonably

accounts for potential exposures. Based

on the considerations above, EPA

determined that the tenfold FQPA safety

factor should be replaced with an

uncertainty factor of three for acute,

27470 Federal Register / Vol. 66, No. 96 / Thursday, May 17, 2001 / Rules and Regulations

short- and intermediate-term, and

chronic risk assessments. While

evidence of increased sensitivity of

young rats following pre- and/or postnatal exposure to cyfluthrin was

observed in the three-generation

reproduction study in rats, an

uncertainty factor of 3 was selected

because of the lack of severity of effects

(reduced body weight gain in males in

chronic toxicity study and decreased

body weight gain in parental animals in

the reproduction study) and the

availability of acceptable reproduction

(rat) and developmental (rats and

rabbits) toxicity studies.

D. Aggregate Risks and Determination of

Safety

To estimate total aggregate exposure

to a pesticide from food, drinking water,

and residential uses, the Agency

calculates DWLOCs which are used as a

point of comparison against the model

estimates of a pesticide’s concentration

in water (EECs). DWLOC values are not

regulatory standards for drinking water.

DWLOCs are theoretical upper limits on

a pesticide’s concentration in drinking

water in light of total aggregate exposure

to a pesticide in food and residential

uses. In calculating a DWLOC, the

Agency determines how much of the

acceptable exposure (i.e., the PAD) is

available for exposure through drinking

water e.g., allowable chronic water

exposure (mg/kg/day) = cPAD - (average

food + chronic non-dietary, nonoccupational exposure). This allowable

exposure through drinking water is used

to calculate a DWLOC.

A DWLOC will vary depending on the

toxic endpoint, drinking water

consumption, and body weights. Default

body weights and consumption values

as used by the USEPA Office of Water

are used to calculate DWLOCs: 2L/70 kg

(adult male), 2L/60 kg (adult female),

and 1L/10 kg (child). Default body

weights and drinking water

consumption values vary on an

individual basis. This variation will be

taken into account in more refined

screening-level and quantitative

drinking water exposure assessments.

Different populations will have different

DWLOCs. Generally, a DWLOC is

calculated for each type of risk

assessment used: acute, short-term,

intermediate-term, chronic, and cancer.

When EECs for surface water and

groundwater are less than the calculated

DWLOCs, OPP concludes with

reasonable certainty that exposures to

cyfluthrin in drinking water (when

considered along with other sources of

exposure for which OPP has reliable

data) would not result in unacceptable

levels of aggregate human health risk at

this time. Because OPP considers the

aggregate risk resulting from multiple

exposure pathways associated with a

pesticide’s uses, levels of comparison in

drinking water may vary as those uses

change. If new uses are added in the

future, OPP will reassess the potential

impacts of cyfluthrin on drinking water

as a part of the aggregate risk assessment

process.

1. Acute risk. Using the exposure

assumptions discussed in this unit for

acute exposure, the acute dietary

exposure from food to cyfluthrin at the

99.9th percentile will occupy 59% of

the aPAD for the U.S. population, 28%

of the aPAD for females age 13–50 years,

89% of the aPAD for infants and 80%

of the aPAD for children aged 1 through

6 years. In addition, despite the

potential for acute dietary exposure to

cyfluthrin in drinking water, after

calculating DWLOCs and comparing

them to conservative model estimated

environmental concentrations of

cyfluthrin in surface and ground water,

EPA does not expect the aggregate

exposure to exceed 100% of the aPAD,

as shown in the following Table 5:

TABLE 5.—AGGREGATE RISK ASSESSMENT FOR ACUTE EXPOSURE TO CYFLUTHRIN

Population Subgroup aPAD (mg/

kg/day)

% aPAD

(Food)

Surface

Water EEC

(ppb)

Ground

Water EEC

(ppb)

Acute

DWLOC

(ppb)

U.S. population 0.07 59 1.2 0.006 1,000

All infants < 1 yr. 0.07 89 1.2 0.006 1500

Children 1–6 yrs. 0.07 80 1.2 0.006 140

Female 13–50 yrs. 0.07 28 1.2 0.006 80

2. Chronic risk. Using the exposure

assumptions described in this unit for

chronic exposure, EPA has concluded

that exposure to cyfluthrin from food

will utilize 30% of the cPAD for the

U.S. population, 26% of the cPAD for

infants < 1 yr. and 73% of the cPAD for

children 1 through 6 years. Based on the

use pattern, chronic residential

exposure to residues of cyfluthrin is not

expected. In addition, despite the

potential for chronic dietary exposure to

cyfluthrin in drinking water, after

calculating DWLOCs and comparing

them to conservative model estimated

environmental concentrations of

cyfluthrin in surface and ground water,

EPA does not expect the aggregate

exposure to exceed 100% of the cPAD,

as shown in the following Table 6:

TABLE 6.—AGGREGATE RISK ASSESSMENT FOR CHRONIC (NON-CANCER) EXPOSURE TO CYFLUTHRIN

Population Subgroup cPAD mg/

kg/day

% cPAD

(Food)

Surface

Water EEC

(ppb)

Ground

Water EEC

(ppb)

Chronic

DWLOC

(ppb)

U.S. Population 0.008 30 1.2 0.006 200

All infants < 1 yr. 0.008 26 1.2 0.006 79

Children 1–6 yrs. 0.008 73 1.2 0.006 22

Federal Register / Vol. 66, No. 96 / Thursday, May 17, 2001 / Rules and Regulations 27471

3. Short-term risk. Short-term

aggregate exposure takes into account

residential exposure plus chronic

exposure to food and water (considered

to be a background exposure level).

Cyfluthrin is currently registered for

uses that could result in short-term

residential exposure and the Agency has

determined that it is appropriate to

aggregate chronic food and water and

short-term exposures for cyfluthrin.

Using the exposure assumptions

described in this unit for short-term

exposures, EPA has concluded that food

and residential exposures aggregated

result in aggregate MOEs of 1,500 for

adults, 1,400 for children 1 through 6

years old, and 1,600 for infants < 1 year

old. These aggregate MOEs do not

exceed the Agency’s level of concern for

aggregate exposure to food and

residential uses. In addition, short-term

DWLOCs were calculated and compared

to the EECs for chronic exposure of

cyfluthrin in ground water and surface

water. After calculating DWLOCs and

comparing them to the EECs for surface

and ground water, EPA does not expect

short-term aggregate exposure to exceed

the Agency’s level of concern, as shown

in the following Table 7:

TABLE 7.—AGGREGATE RISK ASSESSMENT FOR SHORT-TERM EXPOSURE TO CYFLUTHRIN

Population Subgroup

Aggregate

MOE (Food

+ Residential)

Aggregate

Level of

Concern

(LOC)

Surface

Water EEC

(ppb)

Ground

Water EEC

(ppb)

Short-Term

DWLOC

(ppb)

Adult (male) 1,500 300 1.2 0.006 1,900

Adult (female) 1,500 300 1.2 0.006 1,600

Child 1–6 yrs. 1,400 300 1.2 0.006 530

Infant < 1 yr. 1,600 300 1.2 0.006 540

4. Intermediate-term risk.

Intermediate-term aggregate exposure

takes into account non-dietary, nonoccupational exposure plus chronic

exposure to food and water (considered

to be a background exposure level).

Cyfluthrin is currently registered for

use(s) that could result in intermediateterm residential exposure and the

Agency has determined that it is

appropriate to aggregate chronic food

and water and intermediate-term

exposures for cyfluthrin.

Using the exposure assumptions

described in this unit for intermediateterm exposures, EPA has concluded that

food and residential exposures

aggregated result in aggregate MOEs of

460 for adults, 530 for children 1

through 6, and 470 for infants < 1 year.

These aggregate MOEs do not exceed the

Agency’s level of concern for aggregate

exposure to food and residential uses. In

addition, intermediate-term DWLOCs

were calculated and compared to the

EECs for chronic exposure of cyfluthrin

in ground water and surface water. After

calculating DWLOCs and comparing

them to the EECs for surface and ground

water, EPA does not expect

intermediate-term aggregate exposure to

exceed the Agency’s level of concern, as

shown in the following Table 8:

TABLE 8.— AGGREGATE RISK ASSESSMENT FOR INTERMEDIATE-TERM EXPOSURE TO CYFLUTHRIN

Population Subgroup

Aggregate

MOE (Food

+ Residential)

Aggregate

Level of

Concern

(LOC)

Surface

Water EEC

(ppb)

Ground

Water EEC

(ppb)

IntermediateTerm

DWLOC

(ppb)

Adult (male) 460 300 1.2 0.006 800

Adult (female) 460 300 1.2 0.006 690

Children 1–6 yrs. 530 300 1.2 0.006 290

Infants < 1 yr. 470 300 1.2 0.006 240

5. Aggregate cancer risk for U.S.

population. Cyfluthrin has been

classified as a not likely human

carcinogen (Group E chemical). A

cancer dietary risk assessment is not

required.

6. Determination of safety. Based on

these risk assessments, EPA concludes

that there is a reasonable certainty that

no harm will result to the general

population, and to infants and children

from aggregate exposure to cyfluthrin

residues.

V. Other Considerations

A. Analytical Enforcement Methodology

Adequate enforcement methodology

(gas/liquid chromatography with an

electron capture detector) is available to

enforce the tolerance expression. The

method may be requested from: Calvin

Furlow, PIRIB, IRSD (7502C), Office of

Pesticide Programs, Environmental

Protection Agency, 1200 Pennsylvania

Ave., NW, Washington, DC 20460;

telephone number: (703) 305–5229; email address: furlow.calvin@epa.gov.

B. International Residue Limits

There are no Codex tolerances

established for cyfluthrin on grapes,

raisins, or grains. Nor have any

tolerances been established by Canada

or Mexico for cyfluthrin on grapes,

raisins, or grains (of barley, oat, or

wheat).

VI. Conclusion

Therefore, the tolerances are

established for residues of cyfluthrin,

cyano[4-fluoro-3-phenoxyphenyl]-

methyl-3-[2,2-dichloroethenyl]-2,2-

27472 Federal Register / Vol. 66, No. 96 / Thursday, May 17, 2001 / Rules and Regulations

dimethyl-cyclopropanecarboxylate, in

or on grape at 1.0 ppm; grape, raisin at

1.5 ppm; grain of barley, oat, and wheat

at 2.0 ppm; and fat of cattle, goat, hog,

horse, and sheep at 6.0 ppm.

VII. Objections and Hearing Requests

Under section 408(g) of the FFDCA, as

amended by the FQPA, any person may

file an objection to any aspect of this

regulation and may also request a

hearing on those objections. The EPA

procedural regulations which govern the

submission of objections and requests

for hearings appear in 40 CFR part 178.

Although the procedures in those

regulations require some modification to

reflect the amendments made to the

FFDCA by the FQPA of 1996, EPA will

continue to use those procedures, with

appropriate adjustments, until the

necessary modifications can be made.

The new section 408(g) provides

essentially the same process for persons

to ‘‘object’’ to a regulation for an

exemption from the requirement of a

tolerance issued by EPA under new

section 408(d), as was provided in the

old FFDCA sections 408 and 409.

However, the period for filing objections

is now 60 days, rather than 30 days.

A. What Do I Need to Do to File an

Objection or Request a Hearing?

You must file your objection or

request a hearing on this regulation in

accordance with the instructions

provided in this unit and in 40 CFR part

178. To ensure proper receipt by EPA,

you must identify docket control

number OPP–301126 in the subject line

on the first page of your submission. All

requests must be in writing, and must be

mailed or delivered to the Hearing Clerk

on or before July 16, 2001.

1. Filing the request. Your objection

must specify the specific provisions in

the regulation that you object to, and the

grounds for the objections (40 CFR

178.25). If a hearing is requested, the

objections must include a statement of

the factual issues(s) on which a hearing

is requested, the requestor’s contentions

on such issues, and a summary of any

evidence relied upon by the objector (40

CFR 178.27). Information submitted in

connection with an objection or hearing

request may be claimed confidential by

marking any part or all of that

information as 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.

Mail your written request to: Office of

the Hearing Clerk (1900), Environmental

Protection Agency, 1200 Pennsylvania

Ave., NW., Washington, DC 20460. You

may also deliver your request to the

Office of the Hearing Clerk in Rm. C400,

Waterside Mall, 401 M St., SW.,

Washington, DC 20460. The Office of

the Hearing Clerk is open from 8 a.m.

to 4 p.m., Monday through Friday,

excluding legal holidays. The telephone

number for the Office of the Hearing

Clerk is (202) 260–4865.

2. Tolerance fee payment. If you file

an objection or request a hearing, you

must also pay the fee prescribed by 40

CFR 180.33(i) or request a waiver of that

fee pursuant to 40 CFR 180.33(m). You

must mail the fee to: EPA Headquarters

Accounting Operations Branch, Office

of Pesticide Programs, P.O. Box

360277M, Pittsburgh, PA 15251. Please

identify the fee submission by labeling

it ‘‘Tolerance Petition Fees.’’

EPA is authorized to waive any fee

requirement ‘‘when in the judgement of

the Administrator such a waiver or

refund is equitable and not contrary to

the purpose of this subsection.’’ For

additional information regarding the

waiver of these fees, you may contact

James Tompkins by phone at (703) 305–

5697, by e-mail at

tompkins.jim@epa.gov, or by mailing a

request for information to Mr. Tompkins

at Registration Division (7505C), Office

of Pesticide Programs, Environmental

Protection Agency, 1200 Pennsylvania

Ave., NW., Washington, DC 20460.

If you would like to request a waiver

of the tolerance objection fees, you must

mail your request for such a waiver to:

James Hollins, Information Resources

and Services Division (7502C), Office of

Pesticide Programs, Environmental

Protection Agency, 1200 Pennsylvania

Ave., NW., Washington, DC 20460.

3.Copies for the Docket. In addition to

filing an objection or hearing request

with the Hearing Clerk as described in

Unit VII.A., you should also send a copy

of your request to the PIRIB for its

inclusion in the official record that is

described in Unit I.B.2. Mail your

copies, identified by the docket control

number OPP–301126, to: Public

Information and Records Integrity

Branch, Information Resources and

Services Division (7502C), Office of

Pesticide Programs, Environmental

Protection Agency, 1200 Pennsylvania

Ave., NW., Washington, DC 20460. In

person or by courier, bring a copy to the

location of the PIRIB described in Unit

I.B.2. You may also send an electronic

copy of your request via e-mail to: oppdocket@epa.gov. Please use an ASCII

file format and avoid the use of special

characters and any form of encryption.

Copies of electronic objections and

hearing requests will also be accepted

on disks in WordPerfect 6.1/8.0 or

ASCII file format. Do not include any

CBI in your electronic copy. You may

also submit an electronic copy of your

request at many Federal Depository

Libraries.

B. When Will the Agency Grant a

Request for a Hearing?

A request for a hearing will be granted

if the Administrator determines that the

material submitted shows the following:

There is a 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(s) in the manner sought by the

requestor would be adequate to justify

the action requested (40 CFR 178.32).

VIII. Regulatory Assessment

Requirements

This final rule establishes time

limited tolerances under FFDCA section

408. 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) (Public

Law 104–4). Nor does it require any

special considerations under Executive

Order 12898, entitled Federal Actions to

Address Environmental Justice in

Minority Populations and Low- Income

Populations (59 FR 7629, February 16,

1994); or OMB review or any Agency

action under Executive Order 13045,

entitled Protection of Children from

Environmental Health Risks and Safety

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

This action does not involve any

technical standards that would require

Agency consideration of voluntary

consensus standards pursuant to section

12(d) of the National Technology

Transfer and Advancement Act of 1995

(NTTAA), Public Law 104–113, section

12(d) (15 U.S.C. 272 note). Since

tolerances and exemptions that are

established on the basis of a FIFRA

section 18 exemption under FFDCA

section 408, such as the tolerance in this

final rule, do not require the issuance of

a proposed rule, the requirements of the

Federal Register / Vol. 66, No. 96 / Thursday, May 17, 2001 / Rules and Regulations 27473

Regulatory Flexibility Act (RFA) (5

U.S.C. 601 et seq.) do not apply. In

addition, the Agency has determined

that this action will not have a

substantial direct effect on States, on the

relationship between the national

government and the States, or on the

distribution of power and

responsibilities among the various

levels of government, as specified in

Executive Order 13132, entitled

Federalism (64 FR 43255, August 10,

1999). Executive Order 13132 requires

EPA to develop an accountable process

to ensure ‘‘meaningful and timely input

by State and local officials in the

development of regulatory policies that

have federalism implications.’’ ‘‘Policies

that have federalism implications’’ is

defined in the Executive Order to

include regulations that have

‘‘substantial direct effects on the States,

on the relationship between the national

government and the States, or on the

distribution of power and

responsibilities among the various

levels of government.’’ This final rule

directly regulates growers, food

processors, food handlers and food

retailers, not States. This action does not

alter the relationships or distribution of

power and responsibilities established

by Congress in the preemption

provisions of FFDCA section 408(n)(4).

For these same reasons, the Agency

has determined that this rule does not

have any ‘‘tribal implications’’ as

described in Executive Order 13175,

entitled Consultation and Coordination

with Indian Tribal Governments (65 FR

67249, November 6, 2000). Executive

Order 13175, requires EPA to develop

an accountable process to ensure

‘‘meaningful and timely input by tribal

officials in the development of

regulatory policies that have tribal

implications.’’ ‘‘Policies that have tribal

implications’’ is defined in the

Executive Order to include regulations

that have ‘‘substantial direct effects on

one or more Indian tribes, on the

relationship between the Federal

government and the Indian tribes, or on

the distribution of power and

responsibilities between the Federal

government and Indian tribes.’’ This

rule will not have substantial direct

effects on tribal governments, on the

relationship between the Federal

government and Indian tribes, or on the

distribution of power and

responsibilities between the Federal

government and Indian tribes, as

specified in Executive Order 13175.

Thus, Executive Order 13175 does not

apply to this rule.’’

IX. Submission to Congress and the

Comptroller General

The Congressional Review Act, 5

U.S.C. 801 et seq., as added by the Small

Business Regulatory Enforcement

Fairness Act of 1996, generally provides

that before a rule may take effect, the

agency promulgating the rule must

submit a rule report, which includes a

copy of the rule, to each House of the

Congress and to the Comptroller General

of the United States. EPA will submit 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 United

States prior to publication of this final

rule in the Federal Register. This final

rule is not a ‘‘major rule’’ as defined by

5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

Environmental protection,

Administrative practice and procedure,

Agricultural commodities, Pesticides

and pests, Reporting and recordkeeping

requirements.

Dated: May 3, 2001.

James Jones,

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. 321(q), 346(a) and

371.

2. Section 180.436 is amended by

adding paragraph (b) to read as follows:

§ 180.436 Cyfluthrin; tolerances for

residues.

* * * * *

(b)Section 18 emergency exemptions.

Time-limited tolerances are established

for residues of the insecticide

cyfluthrin, cyano[4-fluoro-3-

phenoxyphenyl]-methyl-3-[2,2-

dichloroethenyl]-2,2-dimethylcyclopropanecarboxylate 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

Barley, grain ................................................................................................................................................. 2.0 6/30/03

Cattle, fat ..................................................................................................................................................... 6.0 6/30/03

Goat, fat ....................................................................................................................................................... 6.0 6/30/03

Grape ........................................................................................................................................................... 1.0 6/30/03

Grape, raisin ................................................................................................................................................ 1.5 6/30/03

Hog, fat ........................................................................................................................................................ 6.0 6/30/03

Horse, fat ..................................................................................................................................................... 6.0 6/30/03

Oat, grain ..................................................................................................................................................... 2.0 6/30/03

Sheep, fat .................................................................................................................................................... 6.0 6/30/03

Wheat, grain ................................................................................................................................................ 2.0 6/30/03

* * * * *

[FR Doc. 01–12440 Filed 5–16–01; 8:45 am]

BILLING CODE 6560–50–S

27474 Federal Register / Vol. 66, No. 96 / Thursday, May 17, 2001 / Rules and Regulations

DEPARTMENT OF DEFENSE

Defense Logistics Agency

48 CFR Parts 5433 and 5452

DLA Acquisition Directive: Alternative

Dispute Resolution

AGENCY: Defense Logistics Agency

(DLA), Defense.

ACTION: Final rule.

SUMMARY: This final rule adds a new

provision to DLA solicitations

concerning the use of alternative

dispute resolution (ADR). The purpose

is to establish ADR as the initial dispute

resolution method, except for certain

circumstances, to increase cooperative

problem solving and reduce litigation.

The provision is optional for offerors;

however, if they agree to the provision,

both the contractor and DLA will be

committed to use of ADR except in

limited circumstances. Increased use of

ADR is consistent with the

Administrative Dispute Resolution Act,

the Federal Acquisition Regulation

(FAR), and Departmental policy.

EFFECTIVE DATE: May 17, 2001.

FOR FURTHER INFORMATION CONTACT: Ms.

Mary Massaro, Procurement Analyst,

Defense Logistics Agency, DLA/J–336, at

(703) 767–1366, or via email to

mary_massaro@hq.dla.mil.

SUPPLEMENTARY INFORMATION:

A. Background

DLA is pursuing several initiatives to

increase the use of ADR in resolving

contract disputes. One way to increase

use of ADR is for the parties to agree,

as part of the contract, that they will use

ADR before initiating litigation. This

type of approach is used by DoD in

partnering agreements and Agencycontractor ADR pacts.

The provision provides a vehicle for

both parties to agree to use ADR.

Offerors can opt out of the provision by

checking the box if they do not want it

in their contract in the event of award.

Offerors can also propose alternate

wording to tailor the language while

retaining the concept.

A proposed rule was published in the

Federal Register on May 16, 2000.

Sixteen commenters submitted

comments. Changes were made to the

proposed rule to clarify or simplify the

language, and to reference existing FAR

and DLA requirements. The language of

the final rule, as revised, appears below.

B. Regulatory Flexibility Act

This final rule does not have a

significant economic impact on a

substantial number of small entities

within the meaning of the Regulatory

Flexibility Act, 5 U.S.C. 601 et seq. An

initial regulatory flexibility analysis was

not performed.

C. Paperwork Reduction Act

This rule does not impose any new

reporting or recordkeeping requirements

that require the approval of OMB under

44 U.S.C. 3501 et seq.

List of Subjects in 48 CFR Parts 5433

and 5452

Government procurement.

For the reasons set forth above, the

Defense Logistics Agency amends 48

CFR Chapter 54 as follows:

1. Part 5433 is added to read as

follows:

PART 5433—PROTESTS, DISPUTES

AND APPEALS

Authority: 10 U.S.C. Chapter 137.

5433.214. Alternative Dispute Resolution

(ADR).

The contracting officer shall insert the

provision in 5452.233 in all solicitations

unless the conditions at FAR 33.203(b)

apply.

PART 5452—SOLICITATION

PROVISIONS AND CONTRACT

CLAUSES

2. The authority citation for Part 5452

continues to read as follows:

Authority: 10 U.S.C. Chapter 137.

3. Part 5452 is amended by adding

solicitation provision 5452.233–9001 to

read as follows:

5452.233–9001 Disputes: Agreement to

Use Alternative Dispute Resolution (ADR).

As prescribed in 5433.214, insert the

following provision:

Disputes: Agreement to Use Alternative

Dispute Resolution (ADR) (Apr 2001)—

DLAD

(a) The parties agree to negotiate with each

other to try to resolve any disputes that may

arise. If unassisted negotiations are

unsuccessful, the parties will use alternative

dispute resolution (ADR) techniques to try to

resolve the dispute. Litigation will only be

considered as a last resort when ADR is

unsuccessful or has been documented by the

party rejecting ADR to be inappropriate for

resolving the dispute.

(b) Before either party determines ADR

inappropriate, that party must discuss the

use of ADR with the other party. The

documentation rejecting ADR must be signed

by an official authorized to bind the

contractor (see FAR 52.233–1), or, for the

Agency, by the contracting officer, and

approved at a level above the contracting

officer after consultation with the ADR

Specialist and with legal counsel. Contractor

personnel are also encouraged to include the

ADR Specialist in their discussions with the

contracting officer before determining ADR to

be inappropriate.

(c) If you wish to opt out of this clause,

check here [ ]. Alternate wording may be

negotiated with the contracting officer.

William J. Kenny,

Executive Director, Logistics Policy and

Acquisition Management.

[FR Doc. 01–12450 Filed 5–16–01; 8:45 am]

BILLING CODE 3620–01–M