26466 Federal Register / Vol. 63, No. 92 /Wednesday, May 13, 1998 /Rules and Regulations

Toxics Program, April 6, 1998, IBR

approved for § 63.99(a)(5)(ii) of subpart

E of this part.

Subpart E—Approval of State

Programs and Delegation of Federal

Authorities

3. Section 63.99 is amended by

revising paragraph (a)(5)(ii) introductory

text and adding paragraph (a)(5)(ii)(C),

to read as follows:

§ 63.99 Delegated Federal authorities.

(a) * * *

(5) * * *

(ii) Affected sources must comply

with the California Regulatory

Requirements Applicable to the Air

Toxics Program, April 6, 1998

(incorporated by reference as specified

in § 63.14) as described below.

* * * * *

(C) The material incorporated in

Chapter 3 of the California Regulatory

Requirements Applicable to the Air

Toxics Program (South Coast Air

Quality Management District Rule 1421)

pertains to the perchloroethylene dry

cleaning source category in the South

Coast Air Quality Management District,

and has been approved under the

procedures in § 63.93 to be

implemented and enforced in place of

Subpart M—National Perchloroethylene

Air Emission Standards for Dry

Cleaning Facilities, as it applies to area

sources only, as defined in § 63.320(h).

(1) Authorities not delegated.

(i) South Coast Air Quality

Management District is not delegated

the Administrator’s authority to

implement and enforce Rule 1421 in

lieu of those provisions of Subpart M

which apply to major sources, as

defined in § 63.320(g).

Dry cleaning facilities which are

major sources remain subject to Subpart

M.

(ii) South Coast Air Quality

Management District is not delegated

the Administrator’s authority of § 63.325

to determine equivalency of emissions

control technologies. Any source

seeking permission to use an alternative

means of emission limitation, under

sections (c)(17), (d)(3)(A)(v),

(d)(4)(B)(ii)(III), and (j) of Rule 1421,

must also receive approval from the

Administrator before using such

alternative means of emission limitation

for the purpose of complying with

section 112.

[FR Doc. 98–12430 Filed 5–12–98; 8:45 am]

BILLING CODE 6560–50–P

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Part 180

[OPP–300651; FRL–5788–2]

RIN 2070–AB78

Pyriproxyfen; Pesticide Tolerances for

Emergency Exemptions

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Final rule.

SUMMARY: This regulation establishes

time-limited tolerances for residues of

pyriproxyfen in or on citrus fruit, juice,

dried pulp, and oil; pears; and tomatoes.

This action is in response to EPA’s

granting of emergency exemptions

under section 18 of the Federal

Insecticide, Fungicide, and Rodenticide

Act (FIFRA) authorizing use of the

pesticide on citrus, pears, and tomatoes.

This regulation establishes maximum

permissible levels for residues of

pyriproxyfen in these food and feed

commodities pursuant to section

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

Cosmetic Act (FFDCA), as amended by

the Food Quality Protection Act of 1996

(FQPA). The tolerances will expire and

are revoked on July 31, 1999.

DATES: This regulation is effective May

13, 1998. Objections and requests for

hearings must be received by EPA on or

before July 13, 1998.

ADDRESSES: Written objections and

hearing requests, identified by the

docket control number, [OPP–300651],

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–

300651], must also be submitted to:

Public Information and Records

Integrity Branch, Information Resources

and Services Division (7502C), Office of

Pesticide Programs, Environmental

Protection Agency, 401 M St., SW.,

Washington, DC 20460. In person, bring

a copy of objections and hearing

requests to Rm. 119, CM #2, 1921

Jefferson Davis Hwy., Arlington, VA.

A copy of objections and hearing

requests filed with the Hearing Clerk

may also be submitted electronically by

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

objections and hearing requests must be

submitted as an ASCII file avoiding the

use of special characters and any form

of encryption. Copies of objections and

hearing requests will also be accepted

on disks in WordPerfect 5.1/6.1 file

format or ASCII file format. All copies

of objections and hearing requests in

electronic form must be identified by

the docket control number [OPP–

300651]. 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:

Telephone numbers and e-mail

addresses: For pyriproxyfen on citrus:

Andrea Beard (703) 308-9356, e-mail:

beard.andrea@epamail.epa.gov; For

pyriproxyfen on pears or tomatoes:

Virginia Dietrich (703) 308-9359, e-mail:

dietrich.virginia@epamail.epa.gov.

Office location (both): Crystal Mall #2,

1921 Jefferson Davis Hwy., Arlington,

VA. By mail (both): Registration

Division 7505C, Office of Pesticide

Programs, Environmental Protection

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

DC 20460.

SUPPLEMENTARY INFORMATION: EPA, on

its own initiative, pursuant to section

408(e) and (l)(6) of the FFDCA, 21

U.S.C. 346a(e) and (l)(6), is establishing

tolerances for residues of the pesticide

pyriproxyfen, in or on citrus fruit at 0.3

parts per million (ppm), citrus juice and

dried citrus pulp at 1.0 ppm, and citrus

oil at 300 ppm; pears at 0.2 ppm; and

tomatoes at 0.1 ppm. These tolerances

will expire and are revoked on July 31,

1999. EPA will publish a document in

the Federal Register to remove the

revoked tolerances from the Code of

Federal Regulations.

I. Background and Statutory Authority

The FQPA (Pub. L. 104–170) was

signed into law August 3, 1996. FQPA

amends both the 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 FR 58135, November 13,

1996) (FRL–5572–9).

New section 408(b)(2)(A)(i) of the

FFDCA allows EPA to establish a
Federal Register / Vol. 63, No. 92 /Wednesday, May 13, 1998 /Rules and Regulations 26467

tolerance (the legal limit for a pesticide

chemical residue in or on a food) only

if EPA determines that the tolerance is

‘‘safe.’’ Section 408(b)(2)(A)(ii) defines

‘‘safe’’ to mean that ‘‘there is a

reasonable certainty that no harm will

result from aggregate exposure to the

pesticide chemical residue, including

all anticipated dietary exposures and all

other exposures for which there is

reliable information.’’ This includes

exposure through drinking water and in

residential settings, but does not include

occupational exposure. Section

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

consideration to exposure of infants and

children to the pesticide chemical

residue in establishing a tolerance and

to ‘‘ensure that there is a reasonable

certainty that no harm will result to

infants and children from aggregate

exposure to the pesticide chemical

residue. . . .’’

Section 18 of FIFRA authorizes EPA

to exempt any Federal or State agency

from any provision of FIFRA, if EPA

determines that ‘‘emergency conditions

exist which require such exemption.’’

This provision was not amended by

FQPA. EPA has established regulations

governing such emergency exemptions

in 40 CFR part 166.

Section 408(l)(6) of the FFDCA

requires EPA to establish a time-limited

tolerance or exemption from the

requirement for a tolerance for pesticide

chemical residues in food that will

result from the use of a pesticide under

an emergency exemption granted by

EPA under section 18 of FIFRA. Such

tolerances can be established without

providing notice or period for public

comment.

Because decisions on section 18-

related tolerances must proceed before

EPA reaches closure on several policy

issues relating to interpretation and

implementation of the FQPA, EPA does

not intend for its actions on such

tolerance to set binding precedents for

the application of section 408 and the

new safety standard to other tolerances

and exemptions.

II. Emergency Exemption for

Pyriproxyfen on Citrus and FFDCA

Tolerances

Pyriproxyfen on Citrus: A request was

received from California for use of

pyriproxyfen on citrus to control red

scale, which has developed resistance to

available controls, in some localized

citrus-producing areas of California,

causing significant losses to the affected

citrus producers.

Pyriproxyfen on Pears: A request was

received from Oregon for the use of

pyriproxyfen on pears for control of

pear psylla, which has developed

resistance to currently available

controls, and is expected to cause

significant economic loss if not

adequately controlled.

Pyriproxyfen on Tomatoes: A request

was received from Florida for the use of

pyriproxyfen on tomatoes for control of

whiteflies. A recently introduced strain

or species of whitefly has caused

extensive damage over the past several

years to various vegetable crops in

southern areas of the U.S., including

tomatoes. This pest has demonstrated

resistance to available materials and is

expected to cause significant economic

losses if not adequately controlled.

EPA has authorized under FIFRA

section 18 the use of pyriproxyfen on

citrus for control of red scale in

California; on pears for control of pear

psylla in Oregon; and, on tomatoes for

control of whiteflies in Florida. After

having reviewed the submissions, EPA

concurs that emergency conditions exist

for these States.

As part of its assessment of this

emergency exemption, EPA assessed the

potential risks presented by residues of

pyriproxyfen in or on citrus, pears, and

tomatoes. In doing so, EPA considered

the new 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 new safety standard and with

FIFRA section 18. Consistent with the

need to move quickly on the emergency

exemption in order to address an urgent

non-routine situation and to ensure that

the resulting food is safe and lawful,

EPA is issuing these tolerances without

notice and opportunity for public

comment under section 408(e), as

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

these tolerances will expire and are

revoked on July 31, 1999, under FFDCA

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

pesticide not in excess of the amounts

specified in the tolerances remaining in

or on citrus commodities, pears and

tomatoes 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 pyriproxyfen meets EPA’s

registration requirements for use on

citrus, pears, or tomatoes, or whether

permanent tolerances for these uses

would be appropriate. Under these

circumstances, EPA does not believe

that these tolerances serve as a basis for

registration of pyriproxyfen by a State

for special local needs under FIFRA

section 24(c). Nor do these tolerances

serve as the basis for any State other

than California, Oregon, and Florida to

use this pesticide on these crops under

section 18 of FIFRA without following

all provisions of section 18 as identified

in 40 CFR part 166. For additional

information regarding the emergency

exemption for pyriproxyfen, contact the

Agency’s Registration Division at the

address provided above.

III. Risk Assessment and Statutory

Findings

EPA performs a number of analyses to

determine the risks from aggregate

exposure to pesticide residues. First,

EPA determines the toxicity of

pesticides based primarily on

toxicological studies using laboratory

animals. These studies address many

adverse health effects, including (but

not limited to) reproductive effects,

developmental toxicity, toxicity to the

nervous system, and carcinogenicity.

Second, EPA examines exposure to the

pesticide through the diet (e.g., food and

drinking water) and through exposures

that occur as a result of pesticide use in

residential settings.

A. Toxicity

1. Threshold and non-threshold

effects. For many animal studies, a dose

response relationship can be

determined, which provides a dose that

causes adverse effects (threshold effects)

and doses causing no observed effects

(the ‘‘no-observed effect level’’ or

‘‘NOEL’’).

Once a study has been evaluated and

the observed effects have been

determined to be threshold effects, EPA

generally divides the NOEL from the

study with the lowest NOEL by an

uncertainty factor (usually 100 or more)

to determine the Reference Dose (RfD).

The RfD is a level at or below which

daily aggregate exposure over a lifetime

will not pose appreciable risks to

human health. An uncertainty factor

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

100 is commonly used since it is

assumed that people may be up to 10

times more sensitive to pesticides than

the test animals, and that one person or

subgroup of the population (such as

infants and children) could be up to 10

times more sensitive to a pesticide than

another. In addition, EPA assesses the

potential risks to infants and children

based on the weight of the evidence of

the toxicology studies and determines

whether an additional uncertainty factor
26468 Federal Register / Vol. 63, No. 92 /Wednesday, May 13, 1998 /Rules and Regulations

is warranted. Thus, an aggregate daily

exposure to a pesticide residue at or

below the RfD (expressed as 100% or

less of the RfD) is generally considered

acceptable by EPA. EPA generally uses

the RfD to evaluate the chronic risks

posed by pesticide exposure. For shorter

term risks, EPA calculates a margin of

exposure (MOE) by dividing the

estimated human exposure into the

NOEL from the appropriate animal

study. Commonly, EPA finds MOEs

lower than 100 to be unacceptable. This

100-fold MOE is based on the same

rationale as the 100-fold uncertainty

factor.

Lifetime feeding studies in two

species of laboratory animals are

conducted to screen pesticides for

cancer effects. When evidence of

increased cancer is noted in these

studies, the Agency conducts a weight

of the evidence review of all relevant

toxicological data including short-term

and mutagenicity studies and structure

activity relationship. Once a pesticide

has been classified as a potential human

carcinogen, different types of risk

assessments (e.g., linear low dose

extrapolations or MOE calculation based

on the appropriate NOEL) will be

carried out based on the nature of the

carcinogenic response and the Agency’s

knowledge of its mode of action.

2. Differences in toxic effect due to

exposure duration. The toxicological

effects of a pesticide can vary with

different exposure durations. EPA

considers the entire toxicity data base,

and based on the effects seen for

different durations and routes of

exposure, determines which risk

assessments should be done to assure

that the public is adequately protected

from any pesticide exposure scenario.

Both short and long durations of

exposure are always considered.

Typically, risk assessments include

‘‘acute,’’ ‘‘short-term,’’ ‘‘intermediate

term,’’ and ‘‘chronic’’ risks. These

assessments are defined by the Agency

as follows.

Acute risk, by the Agency’s definition,

results from 1-day consumption of food

and water, and reflects toxicity which

could be expressed following a single

oral exposure to the pesticide residues.

High end exposure to food and water

residues are typically assumed.

Short-term risk results from exposure

to the pesticide for a period of 1-7 days,

and therefore overlaps with the acute

risk assessment. Historically, this risk

assessment was intended to address

primarily dermal and inhalation

exposure which could result, for

example, from residential pesticide

applications. However, since enaction of

FQPA, this assessment has been

expanded to include both dietary and

non-dietary sources of exposure, and

will typically consider exposure from

food, water, and residential uses when

reliable data are available. In this

assessment, risks from average food and

water exposure, and high-end

residential exposure, are aggregated.

High-end exposures from all three

sources are not typically added because

of the very low probability of this

occurring in most cases, and because the

other conservative assumptions built

into the assessment assure adequate

protection of public health. However,

for cases in which high-end exposure

can reasonably be expected from

multiple sources (e.g. frequent and

widespread homeowner use in a

specific geographical area), multiple

high-end risks will be aggregated and

presented as part of the comprehensive

risk assessment/characterization. Since

the toxicological endpoint considered in

this assessment reflects exposure over a

period of at least 7 days, an additional

degree of conservatism is built into the

assessment; i.e., the risk assessment

nominally covers 1-7 days exposure,

and the toxicological endpoint/NOEL is

selected to be adequate for at least 7

days of exposure. (Toxicity results at

lower levels when the dosing duration

is increased.)

Intermediate-term risk results from

exposure for 7 days to several months.

This assessment is handled in a manner

similar to the short-term risk

assessment.

Chronic risk assessment describes risk

which could result from several months

to a lifetime of exposure. For this

assessment, risks are aggregated

considering average exposure from all

sources for representative population

subgroups including infants and

children.

B. Aggregate Exposure

In examining aggregate exposure,

FFDCA section 408 requires that EPA

take into account available and reliable

information concerning exposure from

the pesticide residue in the food in

question, residues in other foods for

which there are tolerances, residues in

groundwater or surface water that is

consumed as drinking water, and other

non-occupational exposures through

pesticide use in gardens, lawns, or

buildings (residential and other indoor

uses). Dietary exposure to residues of a

pesticide in a food commodity are

estimated by multiplying the average

daily consumption of the food forms of

that commodity by the tolerance level or

the anticipated pesticide residue level.

The Theoretical Maximum Residue

Contribution (TMRC) is an estimate of

the level of residues consumed daily if

each food item contained pesticide

residues equal to the tolerance. In

evaluating food exposures, EPA takes

into account varying consumption

patterns of major identifiable subgroups

of consumers, including infants and

children. The TMRC is a ‘‘worst case’’

estimate since it is based on the

assumptions that food contains

pesticide residues at the tolerance level

and that 100% of the crop is treated by

pesticides that have established

tolerances. If the TMRC exceeds the RfD

or poses a lifetime cancer risk that is

greater than approximately one in a

million, EPA attempts to derive a more

accurate exposure estimate for the

pesticide by evaluating additional types

of information (anticipated residue data

and/or percent of crop treated data)

which show, generally, that pesticide

residues in most foods when they are

eaten are well below established

tolerances.

Percent of crop treated estimates are

derived from federal and private market

survey data. Typically, a range of

estimates are supplied and the upper

end of this range is assumed for the

exposure assessment. By using this

upper end estimate of percent of crop

treated, the Agency is reasonably certain

that exposure is not understated for any

significant subpopulation group.

Further, regional consumption

information is taken into account

through EPA’s computer-based model

for evaluating the exposure of

significant subpopulations including

several regional groups, to pesticide

residues. For this pesticide, the most

highly exposed population subgroup

(Children 1 - 6 Years Old) was not

regionally based.

IV. Aggregate Risk Assessment and

Determination of Safety

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

EPA has reviewed the available

scientific data and other relevant

information in support of this action,

EPA has sufficient data to assess the

hazards of pyriproxyfen and to make a

determination on aggregate exposure,

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

time-limited tolerances for residues of

pyriproxyfen on citrus fruit at 0.3 ppm,

citrus juice and dried citrus pulp at 1.0

ppm, and citrus oil at 300 ppm; pears

at 0.2 ppm; and tomatoes at 0.1 ppm.

EPA’s assessment of the dietary

exposures and risks associated with

establishing the tolerances follows.

A. Toxicological Profile

EPA has evaluated the available

toxicity data and considered its validity,

completeness, and reliability as well as
Federal Register / Vol. 63, No. 92 /Wednesday, May 13, 1998 /Rules and Regulations 26469

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 pyriproxyfen are

discussed below.

1. Acute toxicity. There are no acute

dietary endpoints of concern for

pyriproxyfen. No concern exists for

acute dietary exposure to pyriproxyfen

residues.

2. Short - and intermediate - term

toxicity. There are no endpoints and no

concern exists for short- or

intermediate-term toxicity from

pyriproxyfen.

3. Chronic toxicity. EPA has

established the RfD for pyriproxyfen at

0.35 milligrams/kilogram/day (mg/kg/

day). This RfD is based on 2-year and

90-day feeding studies in rats with a

NOEL of 35.1 mg/kg/day and an

uncertainty factor of 100, based on intraand interspecies differences. At the

LOEL of 141.28 mg/kg/day, there was a

decrease in body weight gain in females.

4. Carcinogenicity. Pyriproxyfen has

been classified in Group E of EPA’s

cancer classification system, indicating

there is evidence of non-carcinogenicity

for humans. Therefore, there is no

concern for cancer risk from exposure to

pyriproxyfen.

B. Exposures and Risks

1. From food and feed uses. Timelimited tolerances have been established

(40 CFR 180.510) for the residues of

pyriproxyfen, in or on cotton

commodities, in association with the

use under emergency exemptions. There

are currently no registered food uses for

pyriproxyfen, and thus no permanent

tolerances established. Risk assessments

were conducted by EPA to assess

dietary exposures and risks from

pyriproxyfen as follows:

Chronic exposure and risk. As stated

above, there are time-limited tolerances

for cotton commodities established in

connection with use under emergency

exemptions. This risk assessment took

these into account, as well as these

tolerances being established for citrus

commodities, pears, and tomatoes. The

chronic dietary (food only) risk

assessment used tolerance level residues

and assumed 100% crop treated.

Therefore, the resulting exposure

estimates should be viewed as

conservative; further refinement using

anticipated residues and/or percent of

crop treated would result in lower

dietary exposure estimates. For chronic

dietary (food only) risk estimates, the

two most highly exposed subgroups,

Non-Nursing Infants (<1 Year Old) and

Children (1-6 Years Old) had 1.54 and

1.84% of the RfD utilized, respectively.

All other population subgroups had less

than 1% of the RfD utilized.

2. From drinking water. A Tier II

drinking water assessment of

pyriproxyfen was conducted, using

computer models which simulate the

fate in a surface water body. The

estimated environmental concentrations

(EECs) are generated for high exposure

agricultural scenarios and represent one

in ten years EECs in a stagnant pond

with no outlet that receives pesticide

loading from an adjacent 100% cropped,

100% treated field. As such, these

computer generated EECs represent

conservative screening levels for ponds

and lakes and are used only for

screening. The EECs for surface water

ranged from a peak of 0.677 ppb, to a

60-days average of 0.142 ppb, to a 1-year

average of 0.103 ppb. These estimates

are based on 2 applications at a rate of

0.11 lb. active ingredient per acre. For

ground water, a computer model was

used which resulted in estimated 60-day

average concentrations of pyriproxyfen

of 0.006 ppb.

Chronic exposure and risk. A human

health drinking water level of concern

(DWLOC) is the concentration in

drinking water that would be acceptable

as an upper limit in light of total

aggregate exposure to that chemical

from food, water and non-occupational

(residential) sources. The DWLOC for

chronic risk is the concentration in

drinking water as a part of the aggregate

chronic exposure, that occupies no more

than 100% of the RfD. In conducting

these calculations, default body weights

are used of 70 kg (adult male), 60 kg

(adult female) and 10 kg (child); default

consumption values of water are used of

2 liters per day for adults and 1 liter per

day for children. Using these

assumptions and the levels provided by

the computer models, given above, the

resultant percentage of the RfD utilized

for both children and adults was

calculated to be 0.35%. Therefore,

taking into account present uses,

including this use on citrus under

section 18, EPA concludes that there is

reasonable certainty of no harm if these

tolerances are established.

3. From non-dietary exposure.

Pyriproxyfen is currently registered for

use on the following residential nonfood sites: Products for flea and tick

control, including foggers, aerosol

sprays, emulsifiable concentrates, and

impregnated material (pet collars).

Chronic exposure and risk. Long-term

exposure to pyriproxyfen in residential

use products is not expected. Consumer

use of these products typically results in

short-term intermittent exposures.

Hence, a chronic residential exposure

assessment is not required.

4. Cumulative exposure to substances

with common mechanism of toxicity.

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

when considering whether to establish,

modify, or revoke a tolerance, the

Agency consider ‘‘available

information’’ concerning the cumulative

effects of a particular pesticide’s

residues and ‘‘other substances that

have a common mechanism of toxicity.’’

The Agency believes that ‘‘available

information’’ in this context might

include not only toxicity, chemistry,

and exposure data, but also scientific

policies and methodologies for

understanding common mechanisms of

toxicity and conducting cumulative risk

assessments. For most pesticides,

although the Agency has some

information in its files that may turn out

to be helpful in eventually determining

whether a pesticide shares a common

mechanism of toxicity with any other

substances, EPA does not at this time

have the methodologies to resolve the

complex scientific issues concerning

common mechanism of toxicity in a

meaningful way. EPA has begun a pilot

process to study this issue further

through the examination of particular

classes of pesticides. The Agency hopes

that the results of this pilot process will

increase the Agency’s scientific

understanding of this question such that

EPA will be able to develop and apply

scientific principles for better

determining which chemicals have a

common mechanism of toxicity and

evaluating the cumulative effects of

such chemicals. The Agency anticipates,

however, that even as its understanding

of the science of common mechanisms

increases, decisions on specific classes

of chemicals will be heavily dependent

on chemical specific data, much of

which may not be presently available.

Although at present the Agency does

not know how to apply the information

in its files concerning common

mechanism issues to most risk

assessments, there are pesticides as to

which the common mechanism issues

can be resolved. These pesticides

include pesticides that are

toxicologically dissimilar to existing

chemical substances (in which case the

Agency can conclude that it is unlikely

that a pesticide shares a common

mechanism of activity with other

substances) and pesticides that produce

a common toxic metabolite (in which

case common mechanism of activity

will be assumed).

EPA does not have, at this time,

available data to determine whether

pyriproxyfen has a common mechanism
26470 Federal Register / Vol. 63, No. 92 /Wednesday, May 13, 1998 /Rules and Regulations

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,

pyriproxyfen 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 pyriproxyfen has a

common mechanism of toxicity with

other substances.

C. Aggregate Risks and Determination of

Safety for U.S. Population

1. Acute risk. There are no acute

dietary endpoints of concern for

pyriproxyfen. No concern exists for

acute dietary exposure to pyriproxyfen

residues.

2. Chronic risk. Using the TMRC

exposure assumptions described above,

EPA has concluded that aggregate

exposure to pyriproxyfen from food and

drinking water will utilize 0.67 and

0.35% of the RfD, respectively, for the

U.S. population (total of 1.02% RfD

utilized). The major identifiable

subgroup with the highest aggregate

exposure is Children (1-6 Years Old),

with 1.84 and 0.35% of the RfD utilized

by food and drinking water,

respectively, for a total of 2.19% of the

RfD utilized. This is discussed further

below. EPA generally has no concern for

exposures below 100% of the RfD

because the RfD represents the level at

or below which daily aggregate dietary

exposure over a lifetime will not pose

appreciable risks to human health. EPA

concludes that there is a reasonable

certainty that no harm will result from

aggregate exposure to pyriproxyfen

residues.

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. There are no endpoints and

no concern exists for short- or

intermediate-term toxicity from

pyriproxyfen.

D. Aggregate Cancer Risk for U.S.

Population

Pyriproxyfen has been classified in

Group E of EPA’s cancer classification

system, indicating there is evidence of

non-carcinogenicity for humans.

Therefore, there is no concern for cancer

risk from exposure to pyriproxyfen.

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

pyriproxyfen, EPA considered data from

developmental toxicity studies in the rat

and rabbit and a two-generation

reproduction study in the rat. The

developmental toxicity studies are

designed to evaluate adverse effects on

the developing organism resulting from

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

pre-and post-natal toxicity and the

completeness of the database unless

EPA determines that a different margin

of safety will be safe for infants and

children. Margins of safety are

incorporated into EPA risk assessments

either directly through use of a MOE

analysis or through using uncertainty

(safety) factors in calculating a dose

level that poses no appreciable risk to

humans. EPA believes that reliable data

support using the standard MOE and

uncertainty factor (usually 100 for

combined inter- and intra-species

variability)) and not the additional

tenfold MOE/uncertainty factor when

EPA has a complete data base under

existing guidelines and when the

severity of the effect in infants or

children or the potency or unusual toxic

properties of a compound do not raise

concerns regarding the adequacy of the

standard MOE/safety factor.

ii. Developmental toxicity studies. In

the developmental study in rats, the

maternal (systemic) NOEL was 100 mg/

kg/day, based on decreased bodyweight,

body weight gain, food consumption,

and increased water consumption at the

LOEL of 300 mg/kg/day. The

developmental (fetal) NOEL was 300

mg/kg/day, based on increased skeletal

variations and unspecified visceral

variations at the LOEL of 1,000 mg/kg/

day

In the developmental toxicity study in

rabbits, the maternal (systemic) NOEL

was 100 mg/kg/day, based on abortions,

soft stools, emaciation, decreased

activity, and bradypnea at the LOEL of

300 mg/kg/day. The developmental

(pup) NOEL was 300 mg/kg/day, based

on decreased viable litters available for

examination at the LOEL of 1,000 mg/

kg/day.

iii. Reproductive toxicity study. In the

2-generation reproductive toxicity study

in rats, the maternal (systemic) NOEL

was 87/96 mg/kg/day for Males/

Females, based on decreased body

weights, body weight gains, and

increased liver weight associated with

histopathological findings in the liver at

the LOEL of 453/498 mg/kg/day for M/

F. The developmental (pup) NOEL was

87/96 mg/kg/day, based on decreased

body weight on lactation days 14 and 21

at the LOEL of 453/498 mg/kg/day. The

reproductive NOEL was 453/498 mg/kg/

day for M/F (the highest dose tested).

iv. Pre- and post-natal sensitivity. In

both rats and rabbits, developmental

studies demonstrated that the

developmental findings occurred at

dose levels at which maternal toxicity

was also present, demonstrating no

special pre-natal sensitivity for

developing fetuses. In the post-natal

evaluation to infants and children, as

shown in the results of the rat

reproduction study, the NOEL and

LOEL for both parental systemic toxicity

and pup toxicity occurred at the same

dose levels, demonstrating no special

post-natal sensitivity for infants and

children.

v. Conclusion. Given the fact that

there is a complete toxicity data base for

pyriproxyfen, and no special pre- or

post- natal sensitivities are indicated for

infants and children, an additional 10-

fold safety factor is not warranted. EPA

concludes that there is reasonable

certainty of safety for infants and

children exposed to dietary residues of

pyriproxyfen.

2. Acute risk. There are no acute

dietary endpoints of concern for

pyriproxyfen. No concern exists for

acute dietary exposure to pyriproxyfen

residues.

3. Chronic risk. Using the

conservative exposure assumptions

described above, EPA has concluded

that aggregate exposure to pyriproxyfen

from food will utilize 1.84% of the RfD

for Children 1-6 years old, the most

highly exposed subgroup of 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. The

risk from drinking water is

conservatively estimated to utilize

0.35% of the RfD for infants and

children, as discussed above. Despite

the potential for exposure to

pyriproxyfen in drinking water and

from non-dietary, non-occupational

exposure, EPA does not expect the

aggregate exposure to exceed 100% of

the RfD. EPA concludes that there is a

reasonable certainty that no harm will

result to infants and children from

aggregate exposure to pyriproxyfen

residues.
Federal Register / Vol. 63, No. 92 /Wednesday, May 13, 1998 /Rules and Regulations 26471

4. Short- or intermediate-term risk.

There are no endpoints and no concern

exists for short- or intermediate-term

toxicity from pyriproxyfen.

V. Other Considerations

A. Metabolism In Plants and Animals

For the purposes of these uses under

section 18, the nature of the residue in

plants is adequately understood, and the

residue to be regulated is parent

pyriproxyfen per se [4-phenoxyphenyl

(RS)-2-(2-pyridyloxy)propyl ether].

There are no detectable residues

expected in animal commodities as a

result of these uses.

B. Analytical Enforcement Methodology

Adequate analytical methodology is

available to enforce the tolerance

expression, in residue analytical method

RM-33P-2 using gas chromatography

with a nitrogen-phosphorus detector.

This has been validated by EPA and is

available from the Registrant of

pyriproxyfen, Valent U.S.A.

Corporation, Dublin, California.

C. Magnitude of Residues

Residues of pyriproxyfen are not

expected to exceed 0.3 ppm in/on citrus

fruit, 1.0 ppm in citrus juice and dried

citrus pulp, and 300 ppm in citrus oil;

0.2 ppm in/on pears; and 0.1 ppm in/

on tomatoes; no detectable residues are

expected to occur in animal

commodities, as a result of these

emergency exemption uses.

D. International Residue Limits

There are no Canadian, Mexican, or

Codex maximum residue limits (MRLs)

for residues of pyriproxyfen in/on

citrus, pears, or tomatoes.

E. Rotational Crop Restrictions

There are no applicable rotational

crop restrictions for these emergency

exemption uses.

VI. Conclusion

Therefore, the tolerances are

established for residues of pyriproxyfen

in/on citrus fruit at 0.3 ppm, citrus juice

and dried citrus pulp at 1.0 ppm, and

citrus oil at 300 ppm; 0.2 ppm in/on

pears; and 0.1 ppm in/on tomatoes.

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 July 13, 1998, file

written objections to any aspect of this

regulation and may also request a

hearing on those objections. Objections

and hearing requests must be filed with

the Hearing Clerk, at the address given

above (40 CFR 178.20). A copy of the

objections and/or hearing requests filed

with the Hearing Clerk should be

submitted to the OPP docket for this

rulemaking. The objections submitted

must specify the provisions of the

regulation deemed objectionable and the

grounds for the objections (40 CFR

178.25). Each objection must be

accompanied by the fee prescribed by

40 CFR 180.33(i). If a hearing is

requested, the objections must include a

statement of the factual issues on which

a hearing is requested, the requestor’s

contentions on such issues, and a

summary of any evidence relied upon

by the requestor (40 CFR 178.27). A

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

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

EPA has established a record for this

rulemaking under docket control

number [OPP–300651] (including any

comments and data submitted

electronically). A public version of this

record, including printed, paper

versions of electronic comments, which

does not include any information

claimed as CBI, is available for

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

Monday through Friday, excluding legal

holidays. The public record is located in

Room 119 of the Public Information and

Records Integrity Branch, Information

Resources and Services Division

(7502C), Office of Pesticide Programs,

Environmental Protection Agency,

Crystal Mall #2, 1921 Jefferson Davis

Hwy., Arlington, VA.

Electronic comments may be sent

directly to EPA at:

opp-docket@epamail.epa.gov.

Electronic comments must be

submitted as an ASCII file avoiding the

use of special characters and any form

of encryption.

The official record for this

rulemaking, as well as the public

version, as described above will be kept

in paper form. Accordingly, EPA will

transfer any copies of objections and

hearing requests received electronically

into printed, paper form as they are

received and will place the paper copies

in the official rulemaking record which

will also include all comments

submitted directly in writing. The

official rulemaking record is the paper

record maintained at the Virginia

address in ‘‘ADDRESSES’’ at the

beginning of this document.

IX. Regulatory Assessment

Requirements

This final rule establishes timelimited tolerances under FFDCA section

408(d) in response to petitions

submitted to the Agency. The Office of

Management and Budget (OMB) has

exempted these types of actions from

review under Executive Order 12866,

entitled Regulatory Planning and

Review (58 FR 51735, October 4, 1993).

This final rule does not contain any

information collections subject to OMB

approval under the Paperwork

Reduction Act (PRA), 44 U.S.C. 3501 et

seq., or impose any enforceable duty or

contain any unfunded mandate as

described under Title II of the Unfunded

Mandates Reform Act of 1995 (UMRA)

(Pub. L. 104-4). Nor does it require any

prior consultation as specified by

Executive Order 12875, entitled

Enhancing the Intergovernmental

Partnership (58 FR 58093, October 28,

1993), or special considerations as

required by Executive Order 12898,

entitled Federal Actions to Address

Environmental Justice in Minority

Populations and Low-Income

Populations (59 FR 7629, February 16,

1994), or require OMB review in

accordance with Executive Order 13045,

entitled Protection of Children from

Environmental Health Risks and Safety

Risks (62 FR 19885, April 23, 1997).
26472 Federal Register / Vol. 63, No. 92 /Wednesday, May 13, 1998 /Rules and Regulations

In addition, since these tolerances and

exemptions that are established under

FFDCA section 408 (l)(6), such as the

time-limited 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.

Nevertheless, the Agency has previously

assessed whether establishing

tolerances, exemptions from tolerances,

raising tolerance levels or expanding

exemptions might adversely impact

small entities and concluded, as a

generic matter, that there is no adverse

economic impact. The factual basis for

the Agency’s generic certification for

tolerance actions published on May 4,

1981 (46 FR 24950), and was provided

to the Chief Counsel for Advocacy of the

Small Business Administration.

X. Submission to Congress and the

General Accounting Office

Under 5 U.S.C. 801(a)(1)(A), as added

by the Small Business Regulatory

Enforcement Fairness Act of 1996, the

Agency has submitted a report

containing this rule and other required

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

House of Representatives, and the

Comptroller General of the General

Accounting Office prior to publication

of this rule in today’s Federal Register.

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

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

List of Subjects in 40 CFR Part 180

Environmental protection,

Administrative practice and procedure,

Agricultural commodities, Pesticides

and pests, Reporting and recordkeeping

requirements.

Dated: April 27, 1998.

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. 346a and 371.

2. In § 180.510, in paragraph (b) by

alphabetically adding the following

commodities to the table to read as

follows:

§ 180.510 Pyriproxyfen; tolerances for

residues.

* * * * *

(b) * * *

Commodity Parts per

million

Expiration/revocation

date

Citrus fruit ................ 0.3 7/31/99

Citrus juice ............... 1.0 7/31/99

Citrus oil .................. 300 7/31/99

Citrus pulp, dried ..... 1.0 7/31/99

* * *

* * *

*

Pears ....................... 0.2 7/31/99

Tomatoes ................. 0.1 7/31/99

* * * *

*

[FR Doc. 98–12426 Filed 5–12–98; 8:45 am]

BILLING CODE 6560–50–F

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Part 180

[OPP–300636A; FRL–5787–6]

RIN 2070–AB78

N-(4-fluorophenyl)-N-(1-methylethyl)-2-

[[5-(trifluoromethyl)-1,3,4-thiadiazol-2-

yl]oxy]acetamide; Time-Limited

Pesticide Tolerance, Correction

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Final rule; correction.

SUMMARY: EPA is correcting the timelimited tolerance levels for the

combined residues of the herbicide N-

(4-fluorophenyl)-N-(1-methylethyl)-2-

[[5-(trifluoromethyl)-1,3,4-thiadiazol-2-

yl]oxy]acetamide and its metabolites

containing the 4-fluoro-N-methylethyl

benzenamine moiety in or on corn,

field, grain; corn, field, forage; corn,

field, stover, and soybean seed.

DATES: This correction is effective on

April 10, 1998.

FOR FURTHER INFORMATION CONTACT: By

mail: James A. Tompkins, Registration

Division 7505C, Office of Pesticide

Programs, Environmental Protection

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

DC 20460. Office location, telephone

number, and e-mail address: Crystal

Mall #2, 1921 Jefferson Davis Hwy.,

Arlington, VA, (703) 305–5697, e-mail:

tompkins.jim@epamail.epa.gov.

SUPPLEMENTARY INFORMATION: In the

Federal Register of April 10, 1998 (63

FR 17692)(5782–9), EPA issued a

regulation establishing time-limited

pesticide tolerances under section 408

of the Federal Food, Drug, and Cosmetic

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

residues of N-(4-fluorophenyl)-N-(1-

methylethyl)-2-[[5-(trifluoromethyl)-

1,3,4-thiadiazol-2-yl]oxy]acetamide on

‘‘corn, field, forage,’’ and ‘‘corn, field,

grain’’ corn, field, stover, and soybean

seed (40 CFR 180.527). Inadvertently,

the tolerance levels for corn, field, grain

and corn, field, forage were transposed.

This document corrects the tolerance

levels by correcting § 180.527.

I. Regulatory Assessment Requirements

This final rule does not impose any

requirements. It only implements a

technical correction to the Code of

Federal Regulations (CFR). As such, this

action does not require review by the

Office of Management and Budget

(OMB) under Executive Order 12866,

entitled Regulatory Planning and

Review (58 FR 51735, October 4, 1993),

the Paperwork Reduction Act (PRA), 44

U.S.C. 3501 et seq., or Executive Order

13045, entitled Protection of Children

from Environmental Health Risks and

Safety Risks (62 FR 19885, April 23,

1997). For the same reason, it does not

require any action under Title II of the

Unfunded Mandates Reform Act of 1995

(UMRA) (Pub. L. 104–4), Executive

Order 12875, entitled Enhancing the

Intergovernmental Partnership (58 FR

58093, October 28, 1993), or Executive

Order 12898, entitled Federal Actions to

Address Environmental Justice in

Minority Populations and Low-Income

Populations (59 FR 7629, February 16,

1994). In addition, since this type of

action does not require any proposal, no

action is needed under the Regulatory

Flexibility Act (RFA) (5 U.S.C. 601 et

seq.).

II. Submission to Congress and the

General Accounting Office

Under 5 U.S.C. 801(a)(1)(A), as added

by the Small Business Regulatory

Enforcement Fairness Act of 1996, the

Agency has submitted a report

containing this rule and other required

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

House of Representatives, and the

Comptroller General of the General

Accounting Office prior to publication

of this rule in today’s Federal Register.

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

5 U.S.C. 804(2).’’

List of Subjects in 40 CFR Part 180

Environmental protection,

Administrative practice and procedure,

Agricultural commodities, Pesticides

and pests, Reporting and recordkeeping

requirements.