Federal Register / Vol. 62, No. 53 / Wednesday, March 19, 1997 / Rules and Regulations 12953

26, 1996 notice. Today’s notice also

makes two other technical corrections to

conform with the intent of the

September 17, 1996 final rule.

DATES: Effective date of this document:

December 26, 1996.

Effective date for amended definition

of ‘‘principal limit’’ in § 206.3: May 1,

1997.

FOR FURTHER INFORMATION CONTACT:

Mark W. Holman, Acting Director,

Home Mortgage Insurance Division,

Office of Insured Single Family

Housing, Room number 9270,

Department of Housing and Urban

Development, 451 Seventh Street, SW,

Washington, DC 20410, telephone (202)

708–2121; TTY (202) 708–4594. (These

are not toll-free telephone numbers.)

SUPPLEMENTARY INFORMATION: The

September 17, 1996 final rule issued by

the Department delayed the effective

date for the amendment to the definition

of ‘‘principal limit’’ in § 206.3 until

January 5, 1997. The December 26, 1996

document further delayed the effective

date for the definition of ‘‘principal

limit’’ in § 206.3, until May 1, 1997, but

inadvertently neglected to change the

date references within the definition in

two places. The correct date references

of May 1, 1997 are being substituted

through this correction notice. This

notice also corrects the definition of

‘‘principal limit,’’ as it was set forth in

the September 17, 1996 final rule by

changing ‘‘unless’’ in the fifth sentence

to ‘‘if’’ so that the definition clearly

applies the changed method of

calculating principal limit to mortgages

executed on or after May 1, 1997, as was

intended by the September 17, 1996

final rule. In addition, this notice

corrects the sixth sentence of the

definition of ‘‘principal limit,’’ as it was

set forth in the September 17, 1996 final

rule to add the words ‘‘each month’’

after ‘‘increases’’ and the words ‘‘onetwelfth of’’ after ‘‘rate equal to.’’

Accordingly, in FR Doc. 96–23717, on

page 49032, the definition of ‘‘principal

limit’’ in § 206.3, as set forth in the final

rule published on September 17, 1996,

at 61 FR 49030, is corrected to read as

follows:

§ 206.3 Definitions.

* * * * *

Principal limit means the maximum

disbursement that could be received in

any month under a mortgage, assuming

that no other disbursements are made,

taking into account the age of the

youngest mortgagor, the mortgage

interest rate, and the maximum claim

amount. Mortgagors over the age of 95

will be treated as though they are 95 for

purposes of calculating the principal

limit. The principal limit is used to

calculate payments to a mortgagor. It is

calculated for the first month that a

mortgage could be outstanding using

factors provided by the Secretary. It

increases each month thereafter at a rate

equal to one-twelfth of the mortgage

interest rate in effect at that time, plus

one-twelfth of one-half percent per

annum, if the mortgage was executed on

or after May 1, 1997. If the mortgage was

executed before May 1, 1997, the

principal limit increases each month at

a rate equal to one-twelfth of the

expected average mortgage interest rate

plus one-twelfth of one-half percent per

annum. The principal limit may

decrease because of insurance or

condemnation proceeds applied to the

mortgage balance under § 209.209(b) of

this chapter.

* * * * *

Dated: March 13, 1997.

Nicolas P. Retsinas,

Assistant Secretary for Housing-Federal

Housing Commissioner.

[FR Doc. 97–6860 Filed 3–18–97; 8:45 am]

BILLING CODE 4210–27–P

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Part 180

[OPP–300460; FRL–5594–2]

RIN 2070–AB78

Imidacloprid; Pesticide Tolerances for

Emergency Exemptions

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Final rule.

SUMMARY: This regulation establishes a

time-limited tolerance for combined

residues of the pesticide imidacloprid in

or on the raw agricultural commodity

crop group, cucurbits (Crop Group 9

cucumbers, melons, and squash) in

connection with EPA’s granting of

emergency exemptions under section 18

of the Federal Insecticide, Fungicide,

and Rodenticide Act authorizing use of

imidacloprid on cucurbits in Texas and

California. This regulation establishes

maximum permissible levels for

residues of imidacloprid in these foods.

This tolerance will expire on March 31,

1998.

DATES: This regulation becomes

effective March 19, 1997. The entry in

the table expires on March 31, 1998.

Objections and requests for hearings

must be received by EPA on or before

May 19, 1997.

ADDRESSES: Written objections and

hearing requests, identified by the

docket control number, [OPP–300460],

must be submitted to: Hearing Clerk

(1900), Environmental Protection

Agency, Rm. M3708, 401 M St., SW.,

Washington, DC 20460. Fees

accompanying objections and hearing

requests shall be labeled ‘‘Tolerance

Petition Fees’’ and forwarded to: EPA

Headquarters Accounting Operations

Branch, OPP (Tolerance Fees), P.O. Box

360277M, Pittsburgh, PA 15251. A copy

of any objections and hearing requests

filed with the Hearing Clerk identified

by the docket control number, [OPP–

300460], must also be submitted to:

Public Response and Program Resources

Branch, Field Operations Division

(7506C), Office of Pesticide Programs,

Environmental Protection Agency, 401

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

person, bring a copy of objections and

hearing requests to Rm. 1132, CM #2,

1921 Jefferson Davis Highway.,

Arlington, VA.

A copy of objections and hearing

requests filed with the Hearing Clerk

may also be submitted electronically by

sending electronic mail (e-mail) to: oppdocket@epamail.epa.gov. Such copies of

objections and hearing requests must be

submitted as an ASCII file avoiding the

use of special characters and any form

of encryption. Copies of objections and

hearing requests will also be accepted

on disks in WordPerfect 5.1 file format

or ASCII file format. All copies of

objections and hearing requests in

electronic form must be identified by

the docket control number [OPP–

300460]. No Confidential Business

Information (CBI) should be submitted

through e-mail. Electronic copies of

objections and hearing requests on this

rule may be filed online at many Federal

Depository Libraries.

FOR FURTHER INFORMATION CONTACT: By

mail: Andrea Beard, Registration

Division (7505W), Office of Pesticide

Programs, Environmental Protection

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

DC 20460. Office location, telephone

number, and e-mail: Sixth Floor, Crystal

Station #1, 2800 Jefferson Davis

Highway, Arlington, VA 22202. (703)

308–8791, e-mail:

beard.andrea@epamail.epa.gov.

SUPPLEMENTARY INFORMATION: EPA,

pursuant to section 408(e) and (l)(6) of

the Federal Food, Drug, and Cosmetic

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

(l)(6), is establishing tolerances for

residues of the pesticide imidacloprid

(1-[(6-chloro-3-pyridinyl)methyl]-Nnitro-2-imidazolidinimine), in or on

cucurbits, at 0.2 part per million (ppm).

This tolerance will expire and be

revoked automatically without further

action by EPA on March 31, 1998.
12954 Federal Register / Vol. 62, No. 53 / Wednesday, March 19, 1997 / Rules and Regulations

I. Background and Statutory Authority

The Food Quality Protection Act of

1996 (FQPA) (Pub. L. 104–170) was

signed into law August 3, 1996. FQPA

amends both the Federal Food, Drug,

and Cosmetic Act (FFDCA), 21 U.S.C.

301 et seq., and the FIFRA, 7 U.S.C. 136

et seq. The FQPA amendments went

into effect immediately. Among other

things, FQPA amends FFDCA to bring

all EPA pesticide tolerance-setting

activities under a new section 408 with

a new safety standard and new

procedures. These activities are

described below and discussed in

greater detail in the final rule

establishing the time-limited tolerance

associated with the emergency

exemption for use of propiconazole on

sorghum (61 CFR 58135, November 13,

1996)(FRL–5572–9).

New section 408(b)(2)(A)(i) 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, but does not

include occupational exposure. Section

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

consideration to exposure of infants and

children to the pesticide chemical

residue in establishing a tolerance and

to ‘‘ensure that there is a reasonable

certainty that no harm will result to

infants and children from aggregate

exposure to the pesticide chemical

residue....’’

Section 18 of FIFRA authorizes EPA

to exempt any Federal or State agency

from any provision of FIFRA, if EPA

determines that ‘‘emergency conditions

exist which require such exemption.’’

This provision was not amended by

FQPA. EPA has established regulations

governing such emergency exemptions

in 40 CFR part 166.

Section 408(l)(6) 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. Section 408(l)(6)

also requires EPA to promulgate

regulations by August 3, 1997,

governing the establishment of

tolerances and exemptions under

section 408(l)(6) and requires that the

regulations be consistent with section

408(b)(2) and (c)(2) and FIFRA section

18.

Section 408(l)(6) allows EPA to

establish tolerances or exemptions from

the requirement for a tolerance, in

connection with EPA’s granting of

FIFRA section 18 emergency

exemptions, without providing notice or

a period for public comment. Thus,

consistent with the need to act

expeditiously on requests for emergency

exemptions under FIFRA, EPA can

establish such tolerances or exemptions

under the authority of section 408(e)

and (l)(6) without notice and comment

rulemaking.

In establishing section 18-related

tolerances and exemptions during this

interim period before EPA issues the

section 408(l)(6) procedural regulation

and before EPA makes its broad policy

decisions concerning the interpretation

and implementation of the new section

408, EPA does not intend to set

precedents for the application of section

408 and the new safety standard to other

tolerances and exemptions. Rather,

these early section 18 tolerance and

exemption decisions will be made on a

case-by-case basis and will not bind

EPA as it proceeds with further

rulemaking and policy development.

EPA intends to act on section 18-related

tolerances and exemptions that clearly

qualify under the new law.

II. Emergency Exemption for

Imidacloprid on Cucurbits and FFDCA

Tolerances

The Texas Department of Agriculture

and the California Department of

Pesticide Regulation availed themselves

of the authority to declare the existence

of a crisis situation within their states,

on January 27, and February 5, 1997,

respectively, thereby authorizing use

under FIFRA section 18 of imidacloprid

on cucurbits to control white flies. The

States of Texas and California have also

requested specific exemptions for this

use of imidacloprid. Texas and

California stated that an emergency

situation was present due to this

recently introduced pest, its devastating

effects on the cucurbit crop, and its

resistance to registered alternatives.

Texas and California state that this pest

can have devastating effects on growers’

production and revenue. After having

reviewed their submission, EPA concurs

that an emergency condition exists.

As part of its assessment of these

crisis declarations, EPA assessed the

potential risks presented by residues of

imidacloprid in or on cucurbits. In

doing so, EPA considered the new safety

standard in FFDCA section 408(b)(2),

and EPA decided to grant the section 18

exemptions only after concluding that

the necessary tolerance under FFDCA

section 408(l)(6) would clearly be

consistent with the new safety standard

and with FIFRA section 18. This

tolerance for imidacloprid will permit

the marketing of cucurbits treated in

accordance with the provisions of the

section 18 emergency exemptions.

Consistent with the need to move

quickly on the emergency exemptions

and to ensure that the resulting food is

safe and lawful, EPA is issuing this

tolerance without notice and

opportunity for public comment under

section 408(e) as provided for in section

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

expire and be revoked automatically

without further action by EPA on March

31, 1998, under FFDCA section

408(l)(5), residues of imidacloprid not

in excess of the amount specified in the

tolerance remaining in or on cucurbits

after that date will not be unlawful,

provided the pesticide is applied during

the term of, and in accordance with all

the conditions of, the emergency

exemptions. EPA will take action to

revoke this tolerance earlier if any

experience with, scientific data on, or

other relevant information on this

pesticide indicate that the residues are

not safe.

EPA has not made any decisions

about whether imidacloprid meets the

requirements for registration under

FIFRA section 3 for use on cucurbits, or

whether a permanent tolerance for

imidacloprid for cucurbits would be

appropriate. This action by EPA does

not serve as a basis for registration of

imidacloprid by a State for special local

needs under FIFRA section 24(c). Nor

does this action serve as the basis for

any State other than Texas and

California to use this product on this

crop under section 18 of FIFRA without

following all provisions of section 18 as

identified in 40 CFR part 166. For

additional information regarding the

emergency exemptions for imidacloprid,

contact the Agency’s Registration

Division at the address provided above.

III. Risk Assessment and Statutory

Findings

EPA performs a number of analyses to

determine the risks from aggregate

exposure to pesticide residues. First,

EPA determines the toxicity of

pesticides based primarily on

toxicological studies using laboratory

animals. These studies address many

adverse health effects, including (but

not limited to) reproductive effects,

developmental toxicity, toxicity to the

nervous system, and carcinogenicity.

For many of these studies, a doseresponse relationship can be

determined, which provides a dose that
Federal Register / Vol. 62, No. 53 / Wednesday, March 19, 1997 / Rules and Regulations 12955

causes adverse effects (threshold effects)

and doses causing no observed effects

(the ‘‘no-observed effect level’’ or

‘‘NOEL’’).

Once a study has been evaluated and

the observed effects have been

determined to be threshold effects, EPA

generally divides the NOEL from the

study with the lowest NOEL by an

uncertainty factor (usually 100 or more)

to determine the Reference Dose (RfD).

The RfD is a level at or below which

daily aggregate exposure over a lifetime

will not pose appreciable risks to

human health. An uncertainty factor

(sometimes called a ‘‘safety factor’’) of

100 is commonly used since it is

assumed that people may be up to 10

times more sensitive to pesticides than

the test animals, and that one person or

subgroup of the population (such as

infants and children) could be up to 10

times more sensitive to a pesticide than

another. In addition, EPA assesses the

potential risks to infants and children

based on the weight of the evidence of

the toxicology studies and determines

whether an additional uncertainty factor

is warranted. Thus, an aggregate daily

exposure to a pesticide residue at or

below the RfD (expressed as 100 percent

or less of the RfD) is generally

considered by EPA to pose a reasonable

certainty of no harm.

Lifetime feeding studies in two

species of laboratory animals are

conducted to screen pesticides for

cancer effects. When evidence of

increased cancer is noted in these

studies, the Agency conducts a weightof-the-evidence review of all relevant

toxicological data including short-term

and mutagenicity studies and structureactivity relationships. Once a pesticide

has been classified as a potential human

carcinogen, different types of risk

assessments (e.g., linear low-dose

extrapolations or margin of exposure

calculation based on the appropriate

NOEL) will be carried out based on the

nature of the carcinogenic response and

the Agency’s knowledge of its mode of

action.

In examining aggregate exposure,

FFDCA section 408 requires that EPA

take into account available and reliable

information concerning exposure from

the pesticide residue in the food in

question, residues in other foods for

which there are tolerances, and other

non-occupational exposures, such as

where residues leach into groundwater

or surface water that is consumed as

drinking water. Dietary exposure to

residues of a pesticide in a food

commodity are estimated by

multiplying the average daily

consumption of the food forms of that

commodity by the tolerance level or the

anticipated pesticide residue level. The

Theoretical Maximum Residue

Contribution (TMRC) is an estimate of

the level of residues consumed daily if

each food item contained pesticide

residues equal to the tolerance. The

TMRC is a ‘‘worst case’’ estimate since

it is based on the assumptions that food

contains pesticide residues at the

tolerance level and that 100 percent of

the crop is treated by pesticides that

have established tolerances. If the

TMRC exceeds the RfD or poses a

lifetime cancer risk that is greater than

approximately one in a million, EPA

attempts to derive a more accurate

exposure estimate for the pesticide by

evaluating additional types of

information (anticipated residue data

and/or percent of crop treated data)

which show, generally, that pesticide

residues in most foods when they are

eaten are well below established

tolerances.

IV. Aggregate Risk Assessments,

Cumulative Risk Discussion, and

Determination of Safety

Consistent with section 408(b)(2)(D),

EPA has reviewed the available

scientific data and other relevant

information in support of this action.

Imidacloprid is registered by EPA for

use on turf, as a termiticide, and for flea

control on pets. At this time EPA is not

in possession of a registration

application for imidacloprid on

cucurbits. However, based on

information submitted to the Agency,

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 the

time-limited tolerance for residues of

imidacloprid on cucurbits at 0.2 ppm.

EPA’s assessment of the dietary

exposures and risks associated with

establishing this tolerance follows.

A. Toxicological Profile

1. Chronic toxicity. Based on the

available chronic toxicity data, the

EPA’s Office of Pesticide Programs

(OPP) has established the RfD for

imidacloprid at 0.057 milligrams/

kilogram/day (mg/kg/day). The RfD for

imidacloprid is based on a 2–year

feeding study in rats with a NOEL of 5.7

mg/kg/day and an uncertainty factor of

100. An increase in thyroid lesions in

males was observed at the Lowest Effect

Level (LEL) at 16.9 mg/kg/day.

2. Acute toxicity. Based on the

available acute toxicity data, OPP has

determined that the NOEL of 24 mg/kg/

day from the developmental toxicity

study in rabbits should be used to assess

risk from acute toxicity. Maternal effects

observed at the LEL of 72 mg/kg/day

included decreased body weight and

increased resorptions and abortions.

Fetal effects observed at the LEL of 72

mg/kg/day included an increase in

skeletal abnormalities. The population

subgroup of concern for this risk

assessment is females 13+ years and

older. This subgroup takes into account

both maternal and fetal effects.

3. Short- and intermediate-term

toxicity. OPP has determined that

available data do not demonstrate that

imidacloprid has dermal or inhalation

toxicity potential. Therefore, short-term

or intermediate-term dermal and

inhalation risk assessments, for

occupational and residential exposure

scenarios, are not required.

4. Carcinogenicity. Using its

Guidelines for Carcinogen Risk

Assessment published September 24,

1986 (51 FR 33992), EPA has classified

imidacloprid as a ‘‘Group E’’ chemical

(no evidence of carcinogenicity for

humans) based on the results of

carcinogenicity studies in two species.

The doses tested are adequate for

identifying a cancer risk. Thus, a cancer

risk assessment would not be

appropriate.

B. Aggregate Exposure

Tolerances have been established (40

CFR 180.472) for the combined residues

of imidacloprid (1-[(6-chloro-3-

pyridinyl)methyl]-N-nitro-2-

imidazolidinimine) and its metabolites

containing 6-chloropyridinyl moiety

expressed in or on certain raw

agricultural commodities ranging from

0.02 ppm in eggs to 3.5 ppm in Brassica

vegetable crop group (cabbage, chinese

cabbage, and Kale) and head and leaf

lettuce. There are no livestock feed

items associated with these section 18

requests, so no additional livestock

dietary burden will result from this

section 18 registration. Therefore,

existing meat/milk/poultry tolerances

are adequate.

In conducting this exposure

assessment, EPA has made very

conservative assumptions — 100% of

cucurbits and all other commodities

having imidacloprid tolerances will

contain imidacloprid tolerance residues

and those residues would be at the level

of the tolerance — which result in an

overestimate of human dietary

exposure. Thus, in making a safety

determination for this tolerance, EPA is

taking into account this conservative

exposure assessment.

1. Chronic exposure. Given the

emergency nature of this request for the

use of imidacloprid and the resulting

need for a timely analysis and risk

assessment, EPA has utilized the TMRC

to estimate chronic dietary exposure
12956 Federal Register / Vol. 62, No. 53 / Wednesday, March 19, 1997 / Rules and Regulations

from the tolerances for imidacloprid on

cucurbits at 0.2 ppm. The TMRC is

obtained by multiplying the tolerance

level residue for cucurbits by the

average consumption data, which

estimate the amount of cucurbits eaten

by various population subgroups. This

calculation is performed as well for

every food having existing imidacloprid

tolerances. The risk assessment is

therefore considered to be

overestimated. The Agency has

extensive experience refining chronic

dietary risk assessments for a broad

range of pesticide chemicals. It is OPP’s

experience that when the chronic

dietary risk assessment is refined using

anticipated residue contribution (ARC)

estimates derived from anticipated

residue levels and percent crop treated

data, the percent of the RfD occupied by

the ARC is generally in the range of an

order of magnitude lower than the

percent of the RfD occupied by the

unrefined TMRC. A similar decrease in

estimated exposure to imidacloprid is

expected once more refined data is

received based on ARCs for

imidacloprid on some crops.

In examining aggregate exposure,

FQPA directs EPA to consider available

information concerning exposures from

the pesticide residue in food and all

other non-occupational exposures. The

primary non-food sources of exposure

the Agency looks at include drinking

water (whether from groundwater or

surface water), and exposure through

pesticide use in gardens, lawns, or

buildings (residential and other indoor

uses).

Based on the available studies used in

EPA’s assessment of environmental risk,

imidacloprid is persistent and could

potentially leach into groundwater, and

run off to surface water under certain

environmental conditions. There is no

established Maximum Concentration

Level (MCL) for residues of

imidacloprid in drinking water. No

drinking water health advisories have

been issued for imidacloprid. The

‘‘Pesticides in Groundwater Database’’

(EPA 734–12–92–001, September 1992)

has no information concerning

imidacloprid.

Because the Agency lacks sufficient

water-related exposure data to complete

a comprehensive drinking water risk

assessment for many pesticides, EPA

has commenced and nearly completed a

process to identify a reasonable yet

conservative bounding figure for the

potential contribution of water-related

exposure to the aggregate risk posed by

a pesticide. In developing the bounding

figure, EPA estimated residue levels in

water for a number of specific pesticides

using various data sources. The Agency

then applied the estimated residue

levels, in conjunction with appropriate

toxicological endpoints (RfD’s or acute

dietary NOEL’s) and assumptions about

body weight and consumption, to

calculate, for each pesticide, the

increment of aggregate risk contributed

by consumption of contaminated water.

While EPA has not yet pinpointed the

appropriate bounding figure for

consumption of contaminated water, the

ranges the Agency is continuing to

examine are all below the level that

would cause imidacloprid to exceed the

RfD if the tolerance being considered in

this document were granted. The

Agency has therefore concluded that the

potential exposures associated with

imidacloprid in water, even at the

higher levels the Agency is considering

as a conservative upper bound, would

not prevent the Agency from

determining that there is a reasonable

certainty of no harm if the tolerance is

granted.

2. Acute exposure. EPA has not

estimated non-occupational exposures

other than dietary for imidacloprid.

Acceptable, reliable data are not

currently available with which to assess

acute risk. Imidacloprid is registered for

turf pest control. While dietary and

residential scenarios could possibly

occur in a single day, imidacloprid

would rarely be present on both the

food eaten and the lawn on that single

day. Even assuming this were the case,

it is yet more unlikely that residues

would be present at tolerance level on

all food eaten that day for which

imidacloprid tolerances exist, as is

assumed in the acute dietary risk

analysis, and on the lawn that same day.

Because the acute dietary exposure

estimate assumes tolerance level

residues and 100% crop treated for all

crops evaluated, it is a large overestimate of exposure and it is

considered to be protective of any acute

exposure scenario.

C. Cumulative Exposure to Substances

with Common Mechanism of Toxicity

Section 408(b)(2)(D)(v) requires that,

when considering whether to establish,

modify, or revoke a tolerance, the

Agency consider ‘‘available

information’’ concerning the cumulative

effects of a particular pesticide’s

residues and ‘‘other substances that

have a common mechanism of toxicity.’’

The Agency believes that ‘‘available

information’’ in this context might

include not only toxicity, chemistry,

and exposure data, but also scientific

policies and methodologies for

understanding common mechanisms of

toxicity and conducting cumulative risk

assessments. For most pesticides,

although the Agency has some

information in its files that may turn out

to be helpful in eventually determining

whether a pesticide shares a common

mechanism of toxicity with any other

substances, EPA does not at this time

have the methodologies to resolve the

complex scientific issues concerning

common mechanism of toxicity in a

meaningful way. EPA has begun a pilot

process to study this issue further

through the examination of particular

classes of pesticides. The Agency hopes

that the results of this pilot process will

increase the Agency’s scientific

understanding of this question such that

EPA will be able to develop and apply

scientific principles for better

determining which chemicals have a

common mechanism of toxicity and

evaluating the cumulative effects of

such chemicals. The Agency anticipates,

however, that even as its understanding

of the science of common mechanisms

increases, decisions on specific classes

of chemicals will be heavily dependent

on chemical-specific data, much of

which may not be presently available.

Although at present the Agency does

not know how to apply the information

in its files concerning common

mechanism issues to most risk

assessments, there are pesticides as to

which the common mechanism issues

can be resolved. These pesticides

include pesticides that are

toxicologically dissimilar to existing

chemical substances (in which case the

Agency can conclude that it is unlikely

that a pesticide shares a common

mechanism of activity with other

substances) and pesticides that produce

a common toxic metabolite (in which

case common mechanism of activity

will be assumed).

EPA does not have, at this time,

available data to determine whether

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.

D. Determination of Safety for U.S.

Population

1. Chronic risk. Using the

conservative exposure assumptions

described above, and taking into

account the completeness and reliability

of the toxicity data, EPA has concluded
Federal Register / Vol. 62, No. 53 / Wednesday, March 19, 1997 / Rules and Regulations 12957

that aggregate dietary exposure to

imidacloprid will utilize 16% of the RfD

for the U.S. population. EPA generally

has no concern for exposures below 100

percent 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 RfD. EPA concludes that there is a

reasonable certainty that no harm will

result from aggregate exposure to

imidacloprid residues.

2. Acute risk. For the population

subgroup of concern, females 13+ and

older (accounts for both maternal and

fetal exposure), the calculated Margin of

Exposure (MOE) value is 480. This MOE

does not exceed the Agency’s level of

concern for acute dietary exposure.

E. Determination of Safety for Infants

and Children

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

pesticide exposure during prenatal

development to one or both parents.

Reproduction studies provide

information relating to effects from

exposure to the pesticide on the

reproductive capability of mating

animals and data on systemic toxicity.

In the rat developmental study, the

maternal (systemic) NOEL was 30 mg/

kg/day, based on decreased weight gain

at the LOEL of 100 mg/kg/day. The

developmental (fetal) NOEL was 30 mg/

kg/day based on increased wavy ribs at

the LOEL of 100 mg/kg/day. In the

rabbit developmental study, the

maternal (systemic) NOEL was 24 mg/

kg/day, based on decreased body

weight, increased resorptions and

abortions, and death at the LOEL of 72

mg/kg/day. The developmental (fetal)

NOEL was 24 mg/kg/day, based on

decreased body weight and increased

skeletal anomalies at the LOEL of 72

mg/kg/day.

In the rat developmental study, the

developmental (fetus) and maternal

(mother) NOELs occur at the same dose

level, 24 mg/kg/day. The same response

is seen in the rabbit developmental

study with the developmental (fetus)

and maternal (mother) NOELs occurring

at the same dose level of 30 mg/kg/day.

This suggests that there are no special

prenatal sensitivities for unborn

children in the absence of maternal

toxicity. However, a detailed analysis of

the developmental studies indicates that

the skeletal findings (wavy ribs and

other anomalies) in both the rat and

rabbit fetuses are severe malformations

which occurred in the presence of slight

toxicity (decreases of body weight) in

the maternal animals. Additionally, in

rabbits, there were resorptions and

abortions which can be attributed to

acute maternal exposure. This

information has been interpreted by the

Toxicology Endpoint Selection

Committee (TESC) as indicating a

potential acute dietary risk for prenatally exposed infants.

In the rat reproduction study, the

maternal (systemic) NOEL was 55 mg/

kg/day (the highest dose tested). The

reproductive/developmental NOEL

(effect on the pup) was 8 mg/kg/day,

based on decreased pup body weight

during lactation in both generations at

the LOEL of 19 mg/kg/day.

In the 2-generation rat reproduction

study, the maternal NOEL is 55 mg/kg/

day and the NOEL for decreased pup

body weight during lactation is 8 mg/kg/

day with the LOEL at 19 mg/kg/day.

This study shows that adverse postnatal

development of pups occurs at levels

(19 mg/kg/day) which are lower than

the NOEL for the parental animals (55

mg/kg/day). Therefore, the pups are

more sensitive to the effects of

imidacloprid than parental animals. The

pup NOEL of 8 mg/kg/day in the

reproduction study is 1.4 times greater

than the NOEL of 5.7 from the 2–year

rat feeding study which was the basis of

the RfD. The TMRC value for the most

highly exposed infants and children

subgroup (children 1 to 6 years old)

occupies 31.0% of the RfD.

1. Chronic risk. Using the

conservative exposure assumptions

described above, EPA has concluded

that the percent of the RfD that will be

utilized by aggregate exposure to

residues of imidacloprid ranges from 12

percent for nursing infants, up to 32

percent for children 1 to 6 years old.

Therefore, taking into account the

completeness and reliability of the

toxicity data and the conservative

exposure assessment, EPA concludes

that there is a reasonable certainty that

no harm will result to infants and

children from aggregate exposure to

imidacloprid residues.

2. Acute risk. At present, the acute

dietary MOE for females 13+ years old

(accounts for both maternal and fetal

exposure) is 480. This MOE calculation

was based on the developmental NOEL

in rabbits of 24 mg/kg/day. Maternal

effects observed at the LEL of 72 mg/kg/

day included decreased body weight

and increased resorptions and abortions.

Fetal effects observed at the LEL of 72

mg/kg/day included an increase in

skeletal abnormalities. This risk

assessment also assumed 100% crop

treated with tolerance level residues on

all treated crops consumed, resulting in

a significant over-estimate of dietary

exposure. The large acute dietary MOE

calculated for females 13+ years old

provides assurance that there is a

reasonable certainty of no harm for both

females 13+ years and the pre-natal

development of infants.

FFDCA section 408 provides that EPA

shall apply an additional tenfold margin

of exposure (safety) for infants and

children in the case of threshold effects

to account for pre-and post-natal

toxicity and the completeness of the

database unless EPA determines that a

different MOE (safety) will be safe for

infants and children. Margins of

exposure (safety) are often referred to as

uncertainty (safety) factors. EPA

believes that reliable data support using

the standard MOE (usually 100X for

combined inter- and intra-species

variability) and not the additional

tenfold MOE 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. Based on current

toxicological data requirements, the

database for imidacloprid relative to

pre- (provided by rat and rabbit

developmental studies) and post-natal

(provided by the rat reproduction study)

toxicity is complete. Further, as noted

above, the acute dietary MOE for

women 13+ years or older is 480. This

large MOE demonstrates that the

prenatal exposure to infants is not a

toxicological concern at this time, and

the additional uncertainty factor is not

needed to protect the safety of infants

and children.

Both chronic and acute dietary

exposure risk assessments assume 100%

crop treated and use tolerance level

residues for all commodities.

Refinement of these dietary risk

assessments by using percent crop

treated and anticipated residue data

would greatly reduce dietary exposure.

Therefore, both of these risk

assessments are also an over-estimate of

dietary risk. Consideration of

anticipated residues and percent crop

treated would likely result in an

anticipated residue contribution (ARC)

which would occupy a percent of the

RfD that is likely to be significantly

lower than the currently calculated

TMRC value. Additionally, the acute
12958 Federal Register / Vol. 62, No. 53 / Wednesday, March 19, 1997 / Rules and Regulations

dietary MOE would be greater than the

current MOE. This provides an adequate

safety factor for children during the

prenatal and postnatal development.

It is unlikely that the dietary risk will

exceed 100 percent of the RfD or that

the acute MOE would be greater than

the currently calculated value if, in the

future, an additional safety factor is

deemed appropriate, when considered

in conjunction with a refined exposure

estimate. Therefore, EPA concludes that

there is reasonable certainty that no

harm will result to infants and children

from aggregate exposure to imidacloprid

residues.

V. Other Considerations

The metabolism of imidacloprid in

plants and animals is adequately

understood for the purposes of these

tolerances. There are no Mexican,

Canadian, or Codex maximum residue

levels established for residues of

imidacloprid on cucurbits. There is a

practical analytical method for detecting

and measuring levels of imidacloprid in

or on food with a limit of detection that

allows monitoring of food with residues

at or above the levels set in these

tolerances. EPA has provided

information on this method to FDA. The

method is available to anyone who is

interested in pesticide residue

enforcement from: By mail, Calvin

Furlow, Public Response and Program

Resources Branch, Field Operations

Division (7506C), Office of Pesticide

Programs, Environmental Protection

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

20460. Office location and telephone

number: Crystal Mall #2, Rm 1128, 1921

Jefferson Davis Hwy., Arlington, VA

22202, 703–305–5805.

VI. Conclusion

Therefore, a tolerance in connection

with the FIFRA section 18 emergency

exemptions is established for residues of

imidacloprid in/on cucurbits at 0.2

ppm. This tolerance will expire on

March 31, 1998.

VII. Objections and Hearing Requests

The new FFDCA section 408(g)

provides essentially the same process

for persons to ‘‘object’’ to a tolerance

regulation issued by EPA under new

section 408(e) and (l)(6) as was provided

in the old section 408 and in section

409. However, the period for filing

objections is 60 days, rather than 30

days. EPA currently has procedural

regulations which govern the

submission of objections and hearing

requests. These regulations will require

some modification to reflect the new

law. However, until those modifications

can be made, EPA will continue to use

those procedural regulations with

appropriate adjustments to reflect the

new law.

Any person may, by May 19, 1997 file

written objections to any aspect of this

regulation (including the automatic

revocation provision) and may also

request a hearing on those objections.

Objections and hearing requests must be

filed with the Hearing Clerk, at the

address given above (40 CFR 178.20). A

copy of the objections and/or hearing

requests filed with the Hearing Clerk

should be submitted to the OPP docket

for this rulemaking. The objections

submitted must specify the provisions

of the regulation deemed objectionable

and the grounds for the objections (40

CFR 178.25). Each objection must be

accompanied by the fee prescribed by

40 CFR 180.33(i). If a hearing is

requested, the objections must include a

statement of the factual issues on which

a hearing is requested, the requestor’s

contentions on such issues, and a

summary of any evidence relied upon

by the requestor (40 CFR 178.27). A

request for a hearing will be granted if

the Administrator determines that the

material submitted shows the following:

There is genuine and substantial issue

of fact; there is a reasonable possibility

that available evidence identified by the

requestor would, if established, resolve

one or more of such issues in favor of

the requestor, taking into account

uncontested claims or facts to the

contrary; and resolution of the factual

issues in the manner sought by the

requestor would be adequate to justify

the action requested (40 CFR 178.32).

Information submitted in connection

with an objection or hearing request

may be claimed confidential by marking

any part or all of that information as

Confidential Business Information (CBI).

Information so marked will not be

disclosed except in accordance with

procedures set forth in 40 CFR part 2.

A copy of the information that does not

contain CBI must be submitted for

inclusion in the public record.

Information not marked confidential

may be disclosed publicly by EPA

without prior notice.

VIII. Public Docket

A record has been established for this

rulemaking under docket number [OPP–

300460]. A public version of this record,

which does not include any information

claimed as CBI, is available for

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

Monday through Friday, excluding legal

holidays. The public record is located in

Room 1132 of the Public Response and

Program Resources Branch, Field

Operations Division (7506C), Office of

Pesticide Programs, Environmental

Protection Agency, Crystal Mall #2,

1921 Jefferson Davis Highway,

Arlington, VA.

Electronic comments may be sent

directly to EPA at:

opp-docket@epamail.epa.gov.

Electronic comments must be

submitted as an ASCII file avoiding the

use of special characters and any form

of encryption.

The official record for this

rulemaking, as well as the public

version, as described above, is kept in

paper form. Accordingly, in the event

there are objections and hearing

requests, EPA will transfer any copies of

objections and hearing requests received

electronically into printed, paper form

as they are received and will place the

paper copies in the official rulemaking

record. The official rulemaking record is

the paper record maintained at the

Virginia address in ‘‘ADDRESSES’’ at

the beginning of this document.

IX. Regulatory Assessment

Requirements

Under Executive Order 12866 (58 FR

51735, October 4, 1993), this action is

not a ‘‘significant regulatory action’’

and, since this action does not impose

any information collection requirements

as defined by the Paperwork Reduction

Act, 44 U.S.C. 3501 et seq., it is not

subject to review by the Office of

Management and Budget. This action

does not impose any enforceable duty,

or contain any ‘‘unfunded mandates’’ as

described in Title II of the Unfunded

Mandates Reform Act of 1995 (Pub. L.

104–4), or require prior consultation as

specified by Executive Order 12875 (58

FR 58093, October 28, 1993), entitled

Enhancing the Intergovernmental

Partnership, or special consideration as

required by Executive Order 12898 (59

FR 7629, February 16, 1994).

Because FFDCA section 408(l)(6)

permits establishment of this regulation

without a notice of proposed

rulemaking, the regulatory flexibility

analysis requirements of the Regulatory

Flexibility Act, 5 U.S.C. 604(a), do not

apply.

Under 5 U.S.C. 801(a)(1)(A) of the

Administrative Procedure Act (APA) as

amended by the Small Business

Regulatory Enforcement Fairness Act of

1996 (Title II of Pub. L. 104–121, 110

Stat. 847), EPA submitted a report

containing this rule and other required

information to the U.S. Senate, the U.S.

House of Representatives and the

Comptroller General of the General

Accounting Office prior to publication

of the rule in today’s Federal Register.

This rule is not a ‘‘major rule’’ as

defined by 5 U.S.C. 804(2) of the APA

as amended.
Federal Register / Vol. 62, No. 53 / Wednesday, March 19, 1997 / Rules and Regulations 12959

List of Subjects in 40 CFR Part 180

Environmental protection,

Administrative practice and procedure,

Agricultural commodities, Pesticides

and pests, Reporting and recordkeeping

requirements.

Dated: February 28, 1997.

Peter Caulkins,

Acting Director, Office of Pesticide Programs.

Therefore, 40 CFR Chapter I is

amended as follows:

PART 180—[AMENDED]

1. The authority citation for part 180

continues to read as follows:

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

2. In § 180.472, in paragraph (d), by

adding alphabetically the following

entry to the table:

§ 180.472 Imidacloprid; tolerances for

residues.

* * * * *

CommodityParts per

million

Expiration/Revocation Date

* * * * *

Vegetables,

Cucurbits .......... 0.2 March 31, 1998

* * * * *

[FR Doc. 97–6654 Filed 3–18–97; 8:45 am]

BILLING CODE 6560–50–F

FEDERAL COMMUNICATIONS

COMMISSION

47 CFR Parts 1, 2, 27, and 97

[GN Docket No. 96–228; DA 97–548]

The Wireless Communications Service

(‘‘WCS’’)

AGENCY: Federal Communications

Commission

ACTION: Final rule; petitions for

reconsideration.

SUMMARY: On March 13, 1997, the

Wireless Telecommunications Bureau of

the Federal Communications

Commission released a Public Notice

establishing an expedited pleading cycle

for oppositions and replies to

oppositions to two petitions for

reconsideration of the Commission’s

Report and Order establishing rules and

policies for a new Wireless

Communications Service (‘‘WCS’’) in

the 2305–2320 and 2345–2360 MHz

bands. The Public Notice summarizes

the petitions for reconsideration and

announces that oppositions to the

petitions for reconsideration are due on

or before March 21, 1997, and that

replies to oppositions to the petitions

for reconsideration are due on or before

March 25, 1997.

DATES: Oppositions are due on or before

March 21, 1997. Replies to oppositions

are due on or before March 25, 1997.

FOR FURTHER INFORMATION CONTACT: Josh

Roland or Matthew Moses, Wireless

Telecommunications Bureau, (202) 418–

0660.

SUPPLEMENTARY INFORMATION: This is a

summary of the Public Notice released

on March 13, 1997. The complete Public

Notice is available for inspection and

copying during normal business hours

in the FCC Reference Center (Room

239), 1919 M Street, N.W., Washington,

D.C., 20554, and also may be purchased

from the Commission’s copy contractor,

International transcription Services,

(202) 857–3800, 2100 M Street, N.W.,

Washington, D.C. 20037. The complete

Public Notice is also available on the

Commission’s Internet home page

(http://www.fcc.gov).

Summary of the Public Notice

Expedited Pleading Cycle Established

for Oppositions and Replies to

Oppositions to Petitions for

Reconsideration Filed by the Wireless

Cable Association International, Inc.

and by PACS Providers Forum and

DigiVox Corporation

March 13, 1997.

Oppositions Due: March 21, 1997.

Replies to Oppositions Due: March 25,

1997.

The Federal Communications

Commission has received two petitions

for reconsideration of the Commission’s

Report and Order reallocating the

frequencies at 2305–2320 and 2345–

2360 MHz and establishing auction and

service rules for the Wireless

Communications Service (‘‘WCS’’). See

Amendment of the Commission’s Rules

to Establish Part 27, the Wireless

Communications Service,’’ GN Docket

No. 96–228, Report and Order, FCC 97–

50, 62 FR 9636 (March 3, 1997) (‘‘WCS

Report and Order’’). The Commission’s

action in adopting these rules was taken

in response to the Congressional

mandate expressed in Section 3001 of

the Omnibus Consolidated

Appropriations Act, 1997, that the

Commission reallocate and assign the

use of these frequencies by means of

competitive bidding commencing no

later than April 15, 1997. See Omnibus

Consolidated Appropriations Act, 1997,

Public Law 104–208, 110 Stat. 3009

(1996).

On March 10, 1997, the Wireless

Cable Association International, Inc.

(‘‘WCA’’) filed a ‘‘Petition for Expedited

Reconsideration’’ of the WCS Report

and Order. WCA requests that the

Commission reconsider its decision not

to impose any technical restrictions on

WCS licensees designed to prevent

interference with Multipoint

Distribution Service (‘‘MDS’’) and

Instructional Television Fixed Service

(‘‘ITFS’’) operations in the 2150–2162

and 2500–2690 MHz bands. WCA states

that it is necessary to limit WCS

radiated power to 20 watts EIRP in order

to avoid blanketing interference which

could adversely effect MDS and ITFS

operations throughout the United States.

Interested parties should address the

appropriateness of the proposed power

limitation and its potential effect on

prospective WCS operations. In

addition, it would be useful to have

commenters’ views on whether a

different power limit than that proposed

by WCA would be more appropriate,

and alternatively on whether and in

what circumstances, in the absence of a

specific power limit, a WCS licensee

should be required to take remedial

action if blanketing interference to MDS

or ITFS reception is demonstrated.

On March 11, 1997, PACS Providers

Forum (‘‘PPF’’) and DigiVox

Corporation (‘‘DigiVox’’) jointly filed a

‘‘Petition for Expedited

Reconsideration’’ of the WCS Report

and Order urging the Commission to

reconsider the out-of-band emission

limits adopted for WCS. Specifically,

PPF and DigiVox argue that the out-ofband emission limits for WCS are

unnecessarily stringent, and that lower

limits would permit a greater number of

potential uses for the WCS spectrum

while at the same time protecting

satellite DARS operations in adjacent

spectrum. In addition to requesting

lower out-of-band emission limits

generally, PPF and DigiVox propose that

the Commission adopt additional

operating parameters for certain

operations in the WCS A and B blocks,

such as Personal Access

Communications Systems (‘‘PACS’’).

Commenters are requested to address

whether lower out-of-band emission

limits would adequately protect satellite

DARS operations from interference

caused by WCS operations, and whether

requiring low-power services such as

PACS to employ the proposed

parameters when operating in WCS

spectrum would mitigate the need for

the out-of-band emission limits adopted

in the WCS Report and Order.

In an effort to rapidly resolve these

matters given the statutory deadline of

April 15, 1997, for commencement of