Federal Register / Vol. 65, No. 111 / Thursday, June 8, 2000 / Rules and Regulations 36367

Industry and EPA

hazardous waste

No.

Hazardous waste Hazard

code

*******

F037 ................... Petroleum refinery primary oil/water/solids separation sludge—Any sludge generated from the gravitational separation of oil/water/solids during the storage or treatment of process wastewaters and oil cooling wastewaters from

petroleum refineries. Such sludges include, but are not limited to, those generated in oil/water/solids separators;

tanks and impoundments; ditches and other conveyances; sumps; and stormwater units receiving dry weather

flow. Sludge generated in stormwater units that do not receive dry weather flow, sludges generated from noncontact once-through cooling waters segregated for treatment from other process or oily cooling waters, sludges

generated in aggressive biological treatment units as defined in § 261.31(b)(2) (including sludges generated in

one or more additional units after wastewaters have been treated in aggressive biological treatment units) and

K051 wastes are not included in this listing. This listing does include residuals generated from processing or recycling oil-bearing hazardous secondary materials excluded under § 261.4(a)(12)(i), if those residuals are to be

disposed of.

(T)

*******

* * * * *

PART 268—LAND DISPOSAL

RESTRICTIONS

5. The authority citation for part 268

continues to read as follows:

Authority: 42 U.S.C. 6905, 6912(a), 6921,

and 6924.

Appendix VII to Part 268 [Amended]

6. In appendix VII to part 268 Table

1 is amended by removing the entry for

U048.

[FR Doc. 00–14321 Filed 6–7–00; 8:45 am]

BILLING CODE 6560–50–P

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Part 180

[OPP–301004; FRL–6558–4]

RIN 2070–AB78

Imidacloprid; Pesticide Tolerances for

Emergency Exemptions

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Final rule.

SUMMARY: This regulation establishes

time-limited tolerances for the

combined residues of imidacloprid and

its metabolites containing the 6-

chloropyridinyl moiety, all expressed as

parent in or on stone fruit (Crop Group

12). 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

stone fruit. This regulation establishes

maximum permissible levels for

residues of imidacloprid on these food

commodities. The tolerances will expire

and are revoked on December 31, 2001.

DATES: This regulation is effective June

8, 2000. Objections and requests for

hearings, identified by docket control

number OPP–301004, must be received

by EPA on or before August 7, 2000.

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–

301004 in the subject line on the first

page of your response.

FOR FURTHER INFORMATION CONTACT: By

mail: Andrew Ertman, Registration

Division (7505C), Office of Pesticide

Programs, Environmental Protection

Agency, 1200 Pennsylvania Ave., NW.,

Washington, DC 20460; telephone

number: (703) 308–9367; e-mail address:

ertman.andrew@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:

CategoriesNAICS

codes

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

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’’ and then look

up the entry for this document under

the ‘‘Federal Register—Environmental

Documents.’’ You can also go directly to

the Federal Register listings at http://

www.epa.gov/fedrgstr/.

2. In person. The Agency has

established an official record for this

action under docket control number

OPP–301004. 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

36368 Federal Register / Vol. 65, No. 111 / Thursday, June 8, 2000 / Rules and Regulations

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(l)(6) of the

Federal Food, Drug, and Cosmetic Act

(FFDCA), 21 U.S.C. 346a, is establishing

tolerances for the combined residues of

the insecticide imidacloprid, in or on

stone fruit at 1.0 part per million (ppm)

and the processed commodity prunes at

3.5 ppm. These tolerances will expire

and are revoked on December 31, 2001.

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(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 Exemption for

Imidacloprid on Stone Fruit and

FFDCA Tolerances

There are two situations that have

arisen, resulting in the present

emergency condition. First, currently

there are no reliable insecticides to

control the green peach aphid (GPA) on

peaches and nectarines because of

insecticide resistance. Second, aphids

are a vector for Plum Pox Virus (PPV),

a disease that damages the fruits of

sensitive cultivars of stone fruits. The

mechanism by which aphids transmit

PPV is called non- persistent

transmission. Once an aphid probes into

infected plant tissue and acquires the

virus, the virus can only remain

infectious and be transmitted for a short

period of time (minutes). Each aphid

must feed directly on an infected plant,

acquire sufficient virus, and then fly

immediately to the next plant in order

to effect a transmission.

PPV was discovered for the first time

in the United States in 18 stone fruit

orchards in Adams County,

Pennsylvania in the fall of 1999.

Indications are that PPV has been in

Pennsylvania for several years, and it is

possible that undetected infections of

PPV exist in peach and nectarine

orchards in New Jersey, New York, and

West Virginia. EPA has authorized

under FIFRA section 18 the use of

imidacloprid on stone fruit for control

of aphids in New Jersey, New York,

Pennsylvania and West Virginia. After

having reviewed the 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 imidacloprid in or on stone fruit. 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 each emergency exemption

in order to address an urgent nonroutine situation 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 December 31, 2001, under

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

pesticide not in excess of the amounts

specified in the tolerance remaining in

or on stone fruit 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 a level that was authorized by

these tolerances at the time of that

application. 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 imidacloprid meets EPA’s

registration requirements for use on

stone fruit or whether permanent

tolerances for this use would be

appropriate. Under these circumstances,

EPA does not believe that these

tolerances serve as a basis for

registration of imidacloprid 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 New Jersey, New York,

Pennsylvania, and West Virginia to use

this pesticide on this crop 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

exemption for imidacloprid, 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 imidacloprid and to make a

determination on aggregate exposure,

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

time-limited tolerance for combined

residues of imidacloprid and its

metabolites containing the 6-

chloropyridinyl moiety, all expressed as

parent in or on stone fruit at 1.0 ppm

and prunes 3.5 ppm. EPA’s assessment

Federal Register / Vol. 65, No. 111 / Thursday, June 8, 2000 / Rules and Regulations 36369

of the dietary exposures and risks

associated with establishing these

tolerances 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 imidacloprid are

discussed in this unit.

B. Toxicological Endpoint

Only acute and chronic dietary

endpoints were defined. The 10x FQPA

factor was reduced to 3x for acute and

chronic exposure, and applies to all

population subgroups.

1. Acute toxicity. The acute reference

dose (RfD) is 0.42 milligram/kilogram

body weight/day (mg/kg bwt/day) based

on a lowest observed adverse effect level

(LOAEL) of 42 mg/kg bwt/day based on

decreased motor activity in female rats.

An additional 3x FQPA factor was

incorporated for all population

subgroups to account for neurotoxicity,

structure-activity concerns and lack of a

no observed adverse effect level

(NOAEL). The acute population

adjusted dose (aPAD), which is the

reference dose (RfD/3) was calculated to

be 0.14 mg/kg bwt/day. Acceptable

acute dietary exposure (food plus water)

of 100% or less of the aPAD is required

for all population subgroups.

2. Short- and intermediate-term

toxicity. Dermal and inhalation shortand intermediate-term risk assessments

are not required for imidacloprid as

dermal and inhalation exposure

endpoints were not identified due to the

demonstrated absence of toxicity;

however, because imidacloprid is

registered for use on turf, home gardens

and pets, EPA has identified potential

short-term oral exposures to children for

these uses.

A short-term oral endpoint was not

identified for imidacloprid. According

to current EPA policy, if an oral

endpoint is needed for short-term risk

assessment (for incorporation of food,

water, or oral hand-to-mouth type

exposures into an aggregate risk

assessment), the acute oral endpoint

(LOAEL = 42 mg/kg bwt/day) will be

used to incorporate the oral component

into aggregate risk.

3. Chronic toxicity. EPA has

established the RfD for imidacloprid at

0.057 milligrams/kilograms/day (mg/kg/

day). This RfD is based on increased

number of thyroid lesions at the LOAEL

of 16.9/24.9 mg/kg bwt/day (males and

females, respectively). An additional 3x

FQPA factor was used for all population

subgroups. The chronic population

adjusted dose (cPAD), which is the RfD/

3, was calculated to be 0.019 mg/kg bwt/

day. Acceptable chronic dietary

exposure (food plus water) of 100% or

less of the cPAD is required for all

population subgroups.

4. Carcinogenicity. Imidacloprid has

been classified by the Agency as a

Group E chemical, no evidence of

carcinogenicity for humans, thus, a

cancer risk assessment is not required.

C. Exposures and Risks

1. From food and feed uses.

Tolerances, some time-limited, are

currently established (40 CFR 180.472)

for the combined residues of the

insecticide imidacloprid and its

metabolites containing the 6-

chloropyridinyl moiety, all expressed as

parent, in or on a variety of raw

agricultural and animal commodities at

levels ranging from 0.02 ppm in eggs to

15 ppm in raisins, waste. Risk

assessments were conducted by EPA to

assess dietary exposures and risks from

imidacloprid as follows:

i. Acute exposure and risk. Acute

dietary risk assessments are performed

for a food-use pesticide if a toxicological

study has indicated the possibility of an

effect of concern occurring as a result of

a 1–day or single exposure. In

conducting the acute dietary (food) risk

assessment, EPA used the Theoretical

Maximum Residue Contribution

(TMRC) which assumes tolerance level

residues and 100% crop-treated (Tier 1).

The analysis evaluates individual food

consumption as reported by

respondents in the USDA Continuing

Surveys of Food Intake by Individuals

conducted in 1989 through 1992. The

model accumulates exposure to the

chemical for each commodity and

expresses risk as a function of dietary

exposure. Resulting exposure values (at

the 95th percentile) and percentage of

aPAD utilized ranged from 23% for the

U.S. population to 45% for children 1–

6 years old.

ii. Chronic exposure and risk. In

conducting the chronic dietary (food

only) risk assessment, EPA used:

Tolerance level residues for

imidacloprid and percent crop- treated

(PCT) information for some of these

crops.

The analysis evaluates individual

food consumption as reported by

respondents in the USDA Continuing

Surveys of Food Intake by Individuals

conducted in 1989 through 1992. The

percentages of cPAD consumed for the

general population and subgroups of

interest ranged from 11% for nursing

infants <1 year old to 51% for children

1–6 years old.

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.

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 PCT as required by

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

registrants to submit data on PCT.

The Agency used PCT information as

follows.

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

underestimated. As to Conditions 2 and

3, regional consumption information

and consumption information for

significant subpopulation is taken into

account through EPA’s computer-based

model for evaluating the exposure of

36370 Federal Register / Vol. 65, No. 111 / Thursday, June 8, 2000 / Rules and Regulations

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

data available through national food

consumption surveys, EPA does not

have available information on the

regional consumption of food to which

imidacloprid may be applied in a

particular area.

2. From drinking water. There is no

established Maximum Contaminant

Level for residues of imidacloprid in

drinking water. No health advisory

levels for imidacloprid in drinking

water have been established.

Imidacloprid is persistent, water

soluble, and fairly mobile. Thus,

residues of imidacloprid may be

transported to both surface and ground

waters. As a condition of registration,

the Agency is requiring the submission

of the results of two prospective ground

water monitoring studies. Results from

these studies are not yet available.

i. Acute exposure and risk. Estimated

concentrations of imidacloprid in

surface and ground water used for the

acute exposure analysis were 4.1 and

1.1 micrograms per liter (μg/L) (parts per

billion (ppb)), respectively. These

estimated concentrations of

imidacloprid in surface and ground

water were based upon an application

rate of 0.5 lbs active ingredient/acre/

year (ai/acre/year).

For purposes of risk assessment, the

estimated maximum concentration for

imidacloprid in surface and ground

waters (which is 4.1 μg/L) should be

used for comparison to the backcalculated human health drinking water

levels of concern (DWLOCs) for the

acute endpoint. The DWLOCs ranged

from 800 μg/L for children 1–6 years old

to 3,900 μg/L for the U.S. population.

These figures are well above the

drinking water estimate concentration

(DWEC) of 4.1 μg/L.

ii. Chronic exposure and risk.

Estimated concentrations of

imidacloprid in surface and ground

water for chronic exposure analysis

were 0.1 and 1.1 μg/L (ppb),

respectively. These estimated

concentrations of imidacloprid in

surface and ground water were based

upon an application rate of 0.5 lbs ai/

acre/year.

For purposes of chronic risk

assessment, the estimated maximum

concentration for imidacloprid in

ground waters (which is 1.1 μg/L)

should be used for comparison to the

back-calculated human health DWLOCs

for the chronic (non-cancer) endpoint.

The DWLOCs ranged from 90 μg/L for

children 1–6 years old to 490 μg/L for

the U.S. population. These figures are

well above the DWEC of 1.1 μg/L.

3. From non-dietary exposure.

Imidacloprid is currently registered for

use on the following residential nonfood sites: ornamentals (e.g., flowering

and foliage plants, ground covers, turf,

lawns) tobacco, golf courses, walkways,

recreational areas, household or

domestic dwellings (indoor/outdoor),

and cats/dogs.

i. Acute exposure and risk.

Occupational/residential exposure risk

assessments (namely, short-term dermal,

intermediate-term dermal, long-term

dermal, and inhalation) are not required

owing to the demonstrated absence of

dermal and inhalation toxicity.

ii. Chronic exposure and risk.

Occupational/residential exposure risk

assessments (namely, short-term dermal,

intermediate-term dermal, long-term

dermal, and inhalation) are not required

owing to the demonstrated absence of

dermal and inhalation toxicity.

iii. Short- and intermediate-term

exposure and risk. Short- and

intermediate-term oral exposure are not

expected for adult population

subgroups. However, since imidacloprid

is registered for use on turf, home

gardens and pets, EPA has identified

potential short-term oral exposures to

children for these uses. Thus, a

residential short-term risk assessment

via the oral route is required. See Unit

IV.E.4. for a full discussion of this

exposure and risk.

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

imidacloprid 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,

imidacloprid 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 imidacloprid has a

common mechanism of toxicity with

other substances. For more 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).

D. Aggregate Risks and Determination of

Safety for U.S. Population

1. Acute risk. EPA has determined

that the acute exposure to imidacloprid

from food will utilize 23% of the aPAD

(95th percentile) for the most highly

exposed population subgroup (U.S.

population—all seasons). Despite the

potential for exposure to imidacloprid

in drinking water, the Agency does not

expect the aggregate exposure to exceed

100% of the aPAD. The DWLOC

calculated for the U.S. population was

3,900 μg/L, which is well above the

DWEC of 4.1 μg/L.

2. Chronic risk. In conducting the

chronic dietary (food only) risk

assessment, EPA used: Tolerance level

residues for imidacloprid, and PCT

information for some of these crops. The

analysis evaluates individual food

consumption as reported by

respondents in the USDA Continuing

Surveys of Food Intake by Individuals

conducted in 1989 through 1992. The

percentage of cPAD consumed for the

U.S. population was 24%. The major

identifiable subgroup with the highest

aggregate exposure is discussed below.

EPA generally has no concern for

exposures below 100% of the cPAD

because the cPAD 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

imidacloprid in drinking water, the

Agency does not expect the aggregate

exposure to exceed 100% of the cPAD.

The DWLOC calculated for the U.S.

population was well above the DWEC of

1.1 μg/L.

3. Short- and intermediate-term risk.

Short- and intermediate-term aggregate

exposure takes into account chronic

dietary food and water (considered to be

a background exposure level) plus

indoor and outdoor residential

exposure.

Dermal and inhalation short- and

intermediate-term risk assessments are

not required for imidacloprid, as dermal

and inhalation exposure endpoints were

not identified due to the demonstrated

absence of toxicity. Short- and

intermediate-term oral exposure are not

expected for adult population

subgroups. A discussion of short- and

intermediate- term oral exposure and

Federal Register / Vol. 65, No. 111 / Thursday, June 8, 2000 / Rules and Regulations 36371

risk for children 1–6 can be found in

Unit IV.E.4.

4. Aggregate cancer risk for U.S.

population. Imidacloprid has been

classified as a Group E chemical, no

evidence of carcinogenicity for humans,

thus, a cancer risk assessment is not

required.

5. Determination of safety. Based on

these risk assessments, EPA concludes

that there is a reasonable certainty that

no harm will result from aggregate

exposure to imidacloprid residues.

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

imidacloprid, EPA considered data from

developmental toxicity studies in the rat

and rabbit and a 2-generation

reproduction study in the rat. The

developmental toxicity studies are

designed to evaluate adverse effects on

the developing organism resulting from

maternal pesticide exposure during

gestation. 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

prenatal and postnatal toxicity, and the

completeness of the data base 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. EPA

believes that reliable data support using

the standard MOE and uncertainty

factor (usually 100 for combined

interspecies and intraspecies variability)

and not the additional tenfold MOE/

uncertainty factor when EPA has a

complete data base under existing

guidelines and when the severity of the

effect in infants or children or the

potency or unusual toxic properties of a

compound do not raise concerns

regarding the adequacy of the standard

MOE/safety factor.

ii. Developmental toxicity studies. In

a developmental toxicity study with

Sprague- Dawley rats, groups of

pregnant animals (25/group) received

oral administration of imidacloprid

(94.2%) at 0, 10, 30, or 100 mg/kg bwt/

day during gestation days 6 through 16.

Maternal toxicity was manifested as

decreased body weight gain at all dose

levels and reduced food consumption at

100 mg/kg bwt/day. No treatmentrelated effects were seen in any of the

reproductive parameters (i.e., Cesarean

section evaluation). At 100 mg/kg bwt/

day, developmental toxicity manifested

as wavy ribs (fetus = 7/149 in treated vs.

2/158 in controls and litters, 4/25 vs. 1/

25). For maternal toxicity, the LOAEL

was 10 mg/kg bwt/day lowest dose

tested (LDT) based on decreased body

weight gain; a NOAEL was not

established. For developmental toxicity,

the NOAEL was 30 mg/kg bwt/day and

the LOAEL was 100 mg/kg bwt/day

based on increased wavy ribs.

In a developmental toxicity study

with Chinchilla rabbits, groups of 16

pregnant does were given oral doses of

imidacloprid (94.2%) at 0, 8, 24 or 72

mg/kg bwt/day during gestation days 6

through 18. For maternal toxicity, the

NOAEL was 24 mg/kg bwt/day and the

LOAEL was 72 mg/kg bwt/day based on

mortality, decreased body weight gain,

increased resorptions, and increased

abortions. For developmental toxicity,

the NOAEL was 24 mg/kg bwt/day and

the LOAEL was 72 mg/kg bwt/day based

on decreased fetal body weight,

increased resorptions, and increased

skeletal abnormalities.

iii. Reproductive toxicity study. In a

2–generation reproductive toxicity

study, imidacloprid (95.3%) was

administered to Wistar/Han rats at

dietary levels of 0, 100, 250, or 700 ppm

(0, 7.3, 18.3, or 52.0 mg/kg bwt/day for

males and 0, 8.0, 20.5, or 57.4 mg/kg

bwt/day for females). For parental/

systemic/reproductive toxicity, the

NOAEL was 250 ppm (18.3 mg/kg bwt/

day) and the LOAEL was 750 ppm (52

mg/kg bwt/day), based on decreases in

body weight in both sexes in both

generations. Based on these factors, the

Agency determined that the review be

revised to indicate the parental/

systemic/reproductive NOAEL and

LOAEL to be 250 and 700 ppm,

respectively, based upon the body

weight decrements observed in both

sexes in both generations.

iv. Prenatal and postnatal sensitivity.

The developmental toxicity data

demonstrated no increased sensitivity of

rats or rabbits to in utero exposure to

imidacloprid. In addition, the multigeneration reproductive toxicity study

data did not identify any increased

sensitivity of rats to in utero or postnatal

exposure. Parental NOAELs were lower

or equivalent to developmental or

offspring NOAELs.

v. Conclusion. There is a need for a

developmental neurotoxicity study for

assessment of potential alterations of

functional development. However, the

Agency has determined that this data

gap does not preclude the

establishment/continuance of

tolerances. The 10x safety factor to

account for enhanced sensitivity of

infants and children (as required by

FQPA) was reduced to 3x and the factor

applies to all population subgroups.

2. Acute risk. Using the conservative

TMRC exposure assumptions described

above, and taking into account the

completeness and reliability of the

toxicity data, EPA has estimated the

acute exposure to imidacloprid from

food for the most highly exposed

population subgroup (children 1–6

years old) will utilize 45% of the aPAD.

It was determined that an acceptable

acute dietary exposure (food plus water)

of 100% or less of the aPAD is needed

to protect the safety of all population

subgroups. Despite the potential for

exposure to imidacloprid in drinking

water, EPA does not expect the

aggregate exposure to exceed 100% of

the aPAD for children 1–6 years old.

The maximum concentration of

imidacloprid in surface and ground

water for acute exposure is very small

(4.1 μg/L) compared to the DWEC of 800

μg/L.

3. Chronic risk. Using the exposure

assumptions described in this unit, EPA

has concluded that aggregate exposure

to imidacloprid from food will utilize

51% of the RfD for infants and children.

EPA generally has no concern for

exposures below 100% of the RfD

because the RfD represents the level at

or below which daily aggregate dietary

exposure over a lifetime will not pose

appreciable risks to human health.

Despite the potential for exposure to

imidacloprid in drinking water, EPA

does not expect the aggregate exposure

to exceed 100% of the cPAD for

children 1–6 years old. The maximum

concentration of imidacloprid in surface

and ground water for acute exposure is

very small (1.1 μg/L) compared to the

DWEC of 90 μg/L.

4. Short- and intermediate-term risk.

As noted earlier in this document,

dermal and inhalation short- and

intermediate-term risk assessments are

not required for imidacloprid as dermal

and inhalation exposure endpoints were

not identified due to the demonstrated

absence of toxicity. Short- and

intermediate-term oral exposure are not

expected for adult population

subgroups. However, since imidacloprid

is registered for use on turf, home

gardens and pets, EPA has identified

potential short-term oral exposures to

children for these uses.

A short-term oral endpoint was not

identified for imidacloprid. According

to current EPA policy, if an oral

36372 Federal Register / Vol. 65, No. 111 / Thursday, June 8, 2000 / Rules and Regulations

endpoint is needed for short-term risk

assessment (for incorporation of food,

water, or oral hand-to-mouth type

exposures into an aggregate risk

assessment), the acute oral endpoint

(LOAEL = 42 mg/kg bwt/day) will be

used to incorporate the oral component

into aggregate risk.

The margin of exposure for chronic

dietary exposure (food only) and

residential exposure (hand-to-mouth

from turf, garden, and pet uses) for

children ages 1–6 was calculated to be

300. The safe level for imidacloprid is

300.

Potential short-term exposure from

drinking water is at a level below the

Agency’s level of concern with the

DWLOC (2 μg/L) being greater than the

DWEC of 1.1 μg/L.

The Agency, concludes the short-term

aggregate risk to the highest exposed

population subgroup (children 1–6

years old) from home garden, turf, and

pet uses of imidacloprid does not

exceed EPA’s level of concern.

5. Determination of safety. Based on

these risk assessments, EPA concludes

that there is a reasonable certainty that

no harm will result to infants and

children from aggregate exposure to

imidacloprid residues.

V. Other Considerations

A. Metabolism in Plants and Animals

The nature of imidacloprid residues

in plants and in animals is adequately

understood. The residue of concern is

imidacloprid and its metabolites

containing the 6- chloropyridinyl

moiety, all expressed as parent, as

specified in 40 CFR 180.472.

B. Analytical Enforcement Methodology

Adequate enforcement methodology

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; e-mail address:

furlow.calvin@epa.gov.

C. Magnitude of Residues

Crop field trials on peaches have been

submitted, and the highest residues of

imidacloprid were found to be 0.77

ppm. For the purposes of this section

18, the Agency will translate the peach

residue data to all stone fruit and

tolerances will be set at 1.0 ppm.

The only processed commodity

associated with stone fruit is prunes, as

plums can be processed into prunes.

Since no processing study was

submitted, a default factor of 3.4 was

used, and therefore, the tolerance on

prunes will be set at 3.5 ppm.

D. International Residue Limits

There are no Codex, Canadian, or

Mexican Maximum Residue Limits for

imidacloprid on sweet corn. Thus,

harmonization is not an issue for these

time-limited tolerances.

E. Rotational Crop Restrictions

The rotational crop restrictions follow

the original section 3 labels. In addition,

there is little concern over rotational

crops for this section 18 as stone fruit

are rarely rotated to other crops.

VI. Conclusion

Therefore, the tolerances are

established for the combined residues of

imidacloprid and its metabolites

containing the 6-chloropyridinyl

moiety, all expressed as parent, in or on

stone fruit at 1.0 ppm and prunes at 3.5

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–301004 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 August 7, 2000.

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

Federal Register / Vol. 65, No. 111 / Thursday, June 8, 2000 / Rules and Regulations 36373

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–301004, 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 file

format 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 timelimited 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

prior consultation as specified by

Executive Order 13084, entitled

Consultation and Coordination with

Indian Tribal Governments (63 FR

27655, May 19, 1998); 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 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 petition under FFDCA

section 408, such as the tolerances 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. 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).

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 25, 2000.

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. In §180.472, by alphabetically

adding the following commodities to the

table in paragraph (b) to read as follows:

§ 180.472 Imidacloprid; tolerances for

residues.

*****

(b) Section 18 emergency

exemptions.* * *

Commodity Parts per

million

Expiration/

Revocation

Date

*****

Prunes ............... 3.5 12/31/01

*****

Stone fruit, crop

group 12 ........ 1.0 12/31/01

*****

*****

[FR Doc. 00–14422 Filed 6–7–00; 8:45 am]

BILLING CODE 6560–50–F