37280 Federal Register / Vol. 63, No. 132 / Friday, July 10, 1998 /Rules and Regulations

* * * * *

[FR Doc. 98–18272 Filed 7–9–98; 8:45 am]

BILLING CODE 6560–50–P

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Part 180

[OPP–300677; FRL–5797–7]

RIN 2070–AB78

Bifenthrin; Pesticide Tolerances for

Emergency Exemptions

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Final rule.

SUMMARY: This regulation establishes a

time-limited tolerance for residues of

bifenthrin in or on raspberries. This

action is in response to EPA’s granting

of an emergency exemption under

section 18 of the Federal Insecticide,

Fungicide, and Rodenticide Act

authorizing use of the pesticide on

raspberries. This regulation establishes

maximum permissible levels for

residues of bifenthrin in this food

commodity pursuant to section 408(l)(6)

of the Federal Food, Drug, and Cosmetic

Act, as amended by the Food Quality

Protection Act of 1996. The tolerance

will expire and is revoked on December

31, 1999.

DATES: This regulation is effective July

10, 1998. Objections and requests for

hearings must be received by EPA on or

before September 8, 1998.

ADDRESSES: Written objections and

hearing requests, identified by the

docket control number, [OPP–300677],

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–

300677], 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–

300677]. 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 (7505C), Office of Pesticide

Programs, Environmental Protection

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

DC 20460. Office location, telephone

number, and e-mail address: Crystal

Mall #2, 1921 Jefferson Davis Hwy.,

Arlington, VA, (703) 308–9356, e-mail:

beard.andrea@epamail.epa.gov.

SUPPLEMENTARY INFORMATION: EPA, on

its own initiative, pursuant to section

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

Drug, and Cosmetic Act (FFDCA), 21

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

a tolerance for residues of the

insecticide bifenthrin, in or on

raspberries at 3.0 parts per million

(ppm). This tolerance will expire and is

revoked on December 31, 1999. EPA

will publish a document in the Federal

Register to remove the revoked

tolerance from the Code of Federal

Regulations.

I. Background and Statutory Authority

The Food Quality Protection Act of

1996 (FQPA) (Pub. L. 104–170) was

signed into law August 3, 1996. FQPA

amends both the Federal Food, Drug,

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

301 et seq., and the Federal Insecticide,

Fungicide, and Rodenticide Act

(FIFRA), 7 U.S.C. 136 et seq. The FQPA

amendments went into effect

immediately. Among other things,

FQPA amends FFDCA to bring all EPA

pesticide tolerance-setting activities

under a new section 408 with a new

safety standard and new procedures.

These activities are described below and

discussed in greater detail in the final

rule establishing the time-limited

tolerance associated with the emergency

exemption for use of propiconazole on

sorghum (61 FR 58135, November 13,

1996)(FRL–5572–9).

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

FFDCA allows EPA to establish a

tolerance (the legal limit for a pesticide

chemical residue in or on a food) only

if EPA determines that the tolerance is

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

‘‘safe’’ to mean that ‘‘there is a

reasonable certainty that no harm will

result from aggregate exposure to the

pesticide chemical residue, including

all anticipated dietary exposures and all

other exposures for which there is

reliable information.’’ This includes

exposure through drinking water and in

residential settings, but does not include

occupational exposure. Section

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

consideration to exposure of infants and

children to the pesticide chemical

residue in establishing a tolerance and

to ‘‘ensure that there is a reasonable

certainty that no harm will result to

infants and children from aggregate

exposure to the pesticide chemical

residue. . . .’’

Section 18 of FIFRA authorizes EPA

to exempt any Federal or State agency

from any provision of FIFRA, if EPA

determines that ‘‘emergency conditions

exist which require such exemption.’’

This provision was not amended by

FQPA. EPA has established regulations

governing such emergency exemptions

in 40 CFR part 166.

Section 408(l)(6) of the FFDCA

requires EPA to establish a time-limited

tolerance or exemption from the

requirement for a tolerance for pesticide

chemical residues in food that will

result from the use of a pesticide under

an emergency exemption granted by

EPA under section 18 of FIFRA. Such

tolerances can be established without

providing notice or period for public

comment.

Because decisions on section 18-

related tolerances must proceed before

EPA reaches closure on several policy

issues relating to interpretation and

implementation of the FQPA, EPA does

not intend for its actions on such

tolerance to set binding precedents for

the application of section 408 and the

new safety standard to other tolerances

and exemptions.

II. Emergency Exemption for Bifenthrin

on Raspberries and FFDCA Tolerances

The Applicants state that an

emergency situation is present due to

these pests developing resistance to

available alternatives, and the low

tolerance for weevil contamination in

raspberries. Rejection by the processors

of contaminated raspberries can lead to

significant losses in revenue for the

growers. EPA has authorized under

FIFRA section 18 the use of bifenthrin

on raspberries for control of weevils in

Washington and Oregon. After having

reviewed the submission, EPA concurs
Federal Register / Vol. 63, No. 132 / Friday, July 10, 1998 /Rules and Regulations 37281

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

bifenthrin in or on raspberries. In doing

so, EPA considered the new safety

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

and EPA decided that the necessary

tolerance under FFDCA section 408(l)(6)

would be consistent with the new safety

standard and with FIFRA section 18.

Consistent with the need to move

quickly on the emergency exemption in

order to address an urgent non-routine

situation and to ensure that the resulting

food is safe and lawful, EPA is issuing

this tolerance without notice and

opportunity for public comment under

section 408(e), as provided in section

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

expire and is revoked on December 31,

1999, under FFDCA section 408(l)(5),

residues of the pesticide not in excess

of the amounts specified in the

tolerance remaining in or on raspberries

after that date will not be unlawful,

provided the pesticide is applied in a

manner that was lawful under FIFRA.

EPA will take action to revoke this

tolerance earlier if any experience with,

scientific data on, or other relevant

information on this pesticide indicate

that the residues are not safe.

Because this tolerance is being

approved under emergency conditions

EPA has not made any decisions about

whether bifenthrin meets EPA’s

registration requirements for use on

raspberries or whether a permanent

tolerance for this use would be

appropriate. Under these circumstances,

EPA does not believe that this tolerance

serves as a basis for registration of

bifenthrin by a State for special local

needs under FIFRA section 24(c). Nor

does this tolerance serve as the basis for

any State other than Washington and

Oregon to use this pesticide on this crop

under section 18 of FIFRA without

following all provisions of section 18 as

identified in 40 CFR part 166. For

additional information regarding the

emergency exemption for bifenthrin,

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

inresidential 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

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,
37282 Federal Register / Vol. 63, No. 132 / Friday, July 10, 1998 /Rules and Regulations

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

(non-nursing infants, less than 1 year

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 bifenthrin and to make a

determination on aggregate exposure,

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

time-limited tolerance for residues of

bifenthrin on raspberries at 3.0 ppm.

EPA’s assessment of the dietary

exposures and risks associated with

establishing the tolerance follows.

A. Toxicological Profile

EPA has evaluated the available

toxicity data and considered its validity,

completeness, and reliability as well as

the relationship of the results of the

studies to human risk. EPA has also

considered available information

concerning the variability of the

sensitivities of major identifiable

subgroups of consumers, including

infants and children. The nature of the

toxic effects caused by bifenthrin are

discussed below.

1. Acute toxicity. The maternal NOEL

of 1 milligram/kilogram/day (mg/kg/

day) from the oral developmental

toxicity study in rats is used for acute

dietary risk assessments. The maternal

lowest observable effect level (LOEL) of

this study of 2 mg/kg/day was based on

tremors from day 7-17 of dosing. This

acute dietary endpoint is used to

estimate dietary risks to all population

subgroups.

2. Short - and intermediate - term

toxicity. The maternal NOEL of 1 mg/kg/

day from the oral developmental

toxicity study in rats is also used for

short- and intermediate-term MOE

calculations (as well as acute, discussed

in (1) above).

3. Chronic toxicity. EPA has

established the RfD for bifenthrin at

0.015 mg/kg/day. This RfD is based on

a 1-year oral feeding study in dogs with

a NOEL of 1.5 mg/kg/day, based on

intermittent tremors at the LOEL of 3

mg/kg/day; an uncertainty factor of 100

is used.

4. Carcinogenicity. OPP has classified

bifenthrin as a Group C chemical

(possible human carcinogen) based

upon urinary bladder tumors in mice,

but did not recommend assignment of a

Q*.

B. Exposures and Risks

1. From food and feed uses.

Tolerances have been established (40

CFR 180.442) for the residues of

bifenthrin, in or on a variety of raw

agricultural commodities. Tolerances, in

support of registrations, currently exist

for residues of bifenthrin on hops;

strawberries; corn grain, forage, and

fodder; cotton seed; and livestock

commodities of cattle, goats, hogs,

horses, sheep, and poultry.

Additionally, time-limited tolerances

associated with emergency exemptions

have been established for broccoli,

cauliflower, raspberries, cucurbits, and

canola. Risk assessments were

conducted by Novigen Sciences, Inc.,

and reviewed by EPA, to assess dietary

exposures and risks from bifenthrin as

follows:

i. Acute exposure and risk. Acute

dietary risk assessments are performed

for a food-use pesticide if a toxicological

study has indicated the possibility of an

effect of concern occurring as a result of

a 1 day or single exposure. The acute

risk assessment used Monte Carlo

methodology. This methodology

incorporates distributions of residues

and refined percent of crop treated

estimates, and thus results in highly

refined risk estimates. For the most

highly exposed population subgroup,

children 1-6 years old, the resulting

high-end exposure (at the 99.9th

percentile) results in a dietary (food

only) MOE of 193; at the 99th percentile

the MOE is 1018. For non-nursing

infants <1 Year Old, the high-end

exposure (at the 99.9th percentile) MOE

is 590; at the 99th percentile it is 880.

For the Overall U.S. population, the

high-end exposure (99.9th percentile)

MOE is 466; at the 99th percentile it is

1768. The MOE estimates are all well

within acceptable limits (>100) for all

population subgroups.

ii. Short- and intermediate-term risk.

The short- and intermediate-term risk

assessment used maximum anticipated

residue levels for cotton, extrapolated

residue levels for meat/milk/poultry/

eggs, and air monitoring data collected

from 15 homes in four states. Based on

this data, the MOEs for children are

calculated to be 280 for the average

consumer and 250 for the high-end

consumer. The MOEs for adults are
Federal Register / Vol. 63, No. 132 / Friday, July 10, 1998 /Rules and Regulations 37283

calculated to be 450 for the average

consumer and 390 for the high-end

consumer. EPA generally has no

concern for MOEs greater than 100, and

thus these do not exceed EPA’s level of

concern.

iii. Chronic exposure and risk. The

chronic dietary (food only) risk

assessment for bifenthrin was

conducted using Monte Carlo

methodology, and thus these risk

estimates are highly refined. This risk

assessment estimated that dietary

exposure to bifenthrin will utilize 0.1%

of the RfD for the overall U.S.

population. The major identifiable

subgroup with the highest exposure is

non-nursing infants <1 year old, at 0.3%

of the RfD. This is further discussed

below in the section on infants and

children. EPA generally has no concern

for exposure 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.

2. From drinking water. A Tier II

drinking water assessment of bifenthrin

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 0.260 part per

billion (ppb), to a 90-days average of

0.018 ppb. In conducting both the acute

and chronic risk assessments, Monte

Carlo methodology was again used, and

thus these risk estimates are considered

to be highly refined.

i. Acute exposure and risk. The MOEs

for the acute risk estimate from drinking

water for bifenthrin ranged from 29,035

for the most highly exposed population

subgroup, non-nursing infants (<1 yr

old), to 131,980 for the overall U.S.

population. EPA generally has no

concern for MOEs greater than 100, and

thus these risk estimates are well within

acceptable limits.

ii. Chronic exposure and risk. For the

chronic risk estimates, the percentage of

RfD utilized by contribution through

drinking water was estimated to be well

below 0.0% for all population

subgroups.

3. From non-dietary exposure.

Bifenthrin is currently only registered

for residential non-food use as a

termiticide. Based on information

referred to above regarding short- and

intermediate-term exposure, this use is

not expected to result in risks that

exceed levels of concern. Therefore,

reasonable certainty of no harm is

expected from exposure through nondietary, non-occupational routes.

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

bifenthrin 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,

bifenthrin 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 bifenthrin has a common

mechanism of toxicity with other

substances.

C. Aggregate Risks and Determination of

Safety for U.S. Population

1. Acute risk. For the overall U.S.

population, the calculated MOE value

(for food only) is 466; for food plus

drinking water, this estimate is 464. For

the most highly exposed subgroup,

children 1 - 6 years old, the MOE for

food is 193; from food plus drinking

water, this estimate is 192. As stated

above, EPA generally has no concern for

MOEs greater than 100, and thus these

are within acceptable limits. Therefore,

EPA concludes that there is reasonable

certainty that no harm will result from

acute exposure to bifenthrin.

2. Chronic risk. Using the Monte Carlo

methodology described above, EPA has

concluded that aggregate exposure to

bifenthrin from food will utilize 0.1% of

the RfD for the U.S. population. The

major identifiable subgroup with the

highest aggregate exposure is nonnursing infants <1 year old, with 0.3%

of the RfD utilized, further discussed

below. EPA generally has no concern for

exposures below 100% of the RfD

because the RfD represents the level at

or below which daily aggregate dietary

exposure over a lifetime will not pose

appreciable risks to human health. The

risk estimates from drinking water

exposure are calculated to be well below

0.0% of the RfD for all population

subgroups, and thus do not add

appreciably to the estimates for food

alone. Therefore, EPA concludes that

there is a reasonable certainty that no

harm will result from chronic aggregate

exposure to bifenthrin 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. Based on bifenthrin not being

registered for indoor residential or pet

uses, EPA concludes that the aggregate

short- and intermediate-term risks do
37284 Federal Register / Vol. 63, No. 132 / Friday, July 10, 1998 /Rules and Regulations

not exceed levels of concern, and that

there is reasonable certainty that no

harm will result.

D. 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

bifenthrin, EPA considered data from

developmental toxicity studies in the rat

and rabbit and a 2-generation

reproduction study in the rat. The

developmental toxicity studies are

designed to evaluate adverse effects on

the developing organism resulting from

maternal pesticide exposure during

gestation. Reproduction studies provide

information relating to effects from

exposure to the pesticide on the

reproductive capability of mating

animals and data on systemic toxicity.

FFDCA section 408 provides that EPA

shall apply an additional tenfold margin

of safety for infants and children in the

case of threshold effects to account for

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 100-fold

safety factor (usually 100 for combined

inter-and intra-species variability)) and

not the additional tenfold safety 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 rabbit developmental study, there

were no developmental effects observed

in the fetuses exposed to bifenthrin. The

maternal NOEL was 2.67 mg/kg/day

based on head and forelimb twitching at

the LOEL of 4 mg/kg/day.

In the rat developmental study, the

maternal NOEL was 1 mg/kg/day, based

on tremors at the LOEL of 2 mg/kg/day.

The developmental (pup) NOEL was

also 1 mg/kg/day, based upon increased

incidence of hydroureter at the LOEL of

2 mg/kg/day. There were 5/23 (22%) of

the litters affected (5/141 fetuses since

each litter only had one affected fetus)

in the 2 mg/kg/day group, compared

with zero in the control, 1, and 0.5 mg/

kg/day groups. According to recent

historical data (1992-1994) for this

strain of rat, background incidence of

distended ureter averaged 11% with a

maximum incidence of 90%.

iii. Reproductive toxicity study. In the

rat reproduction study, parental toxicity

occurred as decreased body weight and

tremors at 5.0 mg/kg/day with a NOEL

of 3.0 mg/kg/day. There were no

developmental (pup) or reproductive

effects up to 5.0 mg/kg/day (highest

dose tested).

iv. Pre- and post-natal sensitivity— a.

Pre-natal. Since there was not a doserelated finding of hydroureter in the rat

developmental study and in the

presence of similar incidences in the

recent historical control data, the

marginal finding of hydroureter in rat

fetuses at 2 mg/kg/day (in the presence

of maternal toxicity) is not considered a

significant developmental finding. Nor

does it provide sufficient evidence of a

special dietary risk (either acute or

chronic) for infants and children which

would require an additional safety

factor.

b. Post-natal. Based on the absence of

pup toxicity up to dose levels which

produced toxicity in the parental

animals, there is no evidence of special

post-natal sensitivity to infants and

children in the rat reproduction study.

v. Conclusion. Based on the above,

EPA concludes that reliable data

support use of the standard 100-fold

uncertainty factor, and that an

additional uncertainty factor is not

needed to protect the safety of infants

and children.

2. Acute risk. EPA believes that

residential exposures are more

appropriately included in the short-term

exposure scenario, and thus estimates

acute risk from dietary exposure only.

EPA concluded that aggregate dietary

acute risk (food plus water) would not

exceed levels of concern. This is

discussed in greater detail above.

3. Chronic risk. Using the Monte Carlo

methodology described above, EPA has

concluded that aggregate exposure

estimates to bifenthrin from food will

utilize from 0.1 to 0.3% of the RfD for

infants and children. EPA generally has

no concern for exposures below 100%

of the RfD because the RfD represents

the level at or below which daily

aggregate dietary exposure over a

lifetime will not pose appreciable risks

to human health. EPA concludes that

there is a reasonable certainty that no

harm will result to infants and children

from aggregate exposure to bifenthrin

residues.

4. Short- or intermediate-term risk.

The estimated short- and intermediateterm risks do not exceed EPA’s levels of

concern for children. MOEs for children

are calculated to be 280 for the average

consumer and 250 for the high-end

consumer, discussed in greater detail

above. There is generally no concern for

MOEs which are greater than 100.

V. Other Considerations

A. Metabolism In Plants and Animals

The metabolism of bifenthrin in

raspberries is adequately understood for

the purposes of this tolerance. The

residue of concern is the parent

compound only.

B. Analytical Enforcement Methodology

There is a practical analytical method

for detecting and measuring levels of

bifenthrin in or on food with a limit of

detection that allows monitoring of food

with residues at or above the levels set

in this tolerance document (Gas

chromatography with Electron Capture

Detection, analytical method P-2132M,

PP# 0E3921; MRID#41658601). EPA has

provided information on this method to

FDA. The method is available to anyone

who is interested from OPP’s Health

Effects Division (7509C), Office of

Pesticide Programs, Environmental

Protection Agency, 401 M St., SW.,

Washington, DC 20460.

C. Magnitude of Residues

Residues of bifenthrin are not likely to

exceed 3.0 ppm in or on raspberries as

a result of the proposed use. Secondary

residues are not expected to occur in

animal commodities.

D. International Residue Limits

There are no Codex, Canadian, or

Mexican residue limits for residues of

bifenthrin in or on raspberries.

E. Rotational Crop Restrictions

The confined rotational crop data

requirements for bifenthrin have been

satisfied. The following rotation

instructions are required: (1) Leafy

vegetables and root crops may be rotated

30 days following the final application

of bifenthrin; (2) Crops for which

bifenthrin tolerances exist may be

rotated at any time; and (3) All other

crops may be rotated seven months

following the final application of

bifenthrin. There are no rotational crop

considerations associated with

raspberries.

VI. Conclusion

Therefore, the tolerance is established

for residues of bifenthrin in or on

raspberries at 3.0 ppm.

VII. Objections and Hearing Requests

The new FFDCA section 408(g)

provides essentially the same process

for persons to ‘‘object’’ to a tolerance

regulation issued by EPA under new
Federal Register / Vol. 63, No. 132 / Friday, July 10, 1998 /Rules and Regulations 37285

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 September 8,

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

Confidential Business Information (CBI).

Information so marked will not be

disclosed except in accordance with

procedures set forth in 40 CFR part 2.

A copy of the information that does not

contain CBI must be submitted for

inclusion in the public record.

Information not marked confidential

may be disclosed publicly by EPA

without prior notice.

VIII. Public Record and Electronic

Submissions

EPA has established a record for this

rulemaking under docket control

number [OPP–300677] (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

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 will be kept

in paper form. Accordingly, EPA will

transfer any copies of objections and

hearing requests received electronically

into printed, paper form as they are

received and will place the paper copies

in the official rulemaking record which

will also include all comments

submitted directly in writing. The

official rulemaking record is the paper

record maintained at the Virginia

address in ‘‘ADDRESSES’’ at the

beginning of this document.

IX. Regulatory Assessment

Requirements

This final rule establishes a timelimited tolerance under FFDCA section

408(l)(6). The Office of Management and

Budget (OMB) has exempted these types

of actions from review under Executive

Order 12866, entitled Regulatory

Planning and Review (58 FR 51735,

October 4, 1993). This final rule does

not contain any information collections

subject to OMB approval under the

Paperwork Reduction Act (PRA), 44

U.S.C. 3501 et seq., or impose any

enforceable duty or contain any

unfunded mandate as described under

Title II of the Unfunded Mandates

Reform Act of 1995 (UMRA) (Pub. L.

104-4). Nor does it require any prior

consultation as specified by Executive

Order 12875, entitled Enhancing the

Intergovernmental Partnership (58 FR

58093, October 28, 1993), or special

considerations as required by Executive

Order 12898, entitled Federal Actions to

Address Environmental Justice in

Minority Populations and Low-Income

Populations (59 FR 7629, February 16,

1994), or require OMB review in

accordance with Executive Order 13045,

entitled Protection of Children from

Environmental Health Risks and Safety

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

In addition, since these tolerances and

exemptions that are established under

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

tolerance in this final rule, do not

require the issuance of a proposed rule,

the requirements of the Regulatory

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

seq.) do not apply. Nevertheless, the

Agency has previously assessed whether

establishing tolerances, exemptions

from tolerances, raising tolerance levels

or expanding exemptions might

adversely impact small entities and

concluded, as a generic matter, that

there is no adverse economic impact.

The factual basis for the Agency’s

generic certification for tolerance

actions published on May 4, 1981 (46

FR 24950), and was provided to the

Chief Counsel for Advocacy of the Small

Business Administration.

X. Submission to Congress and the

Comptroller General

The Congressional Review Act, 5

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

Business Regulatory Enforcement

Fairness Act of 1996, generally provides

that before a rule may take effect, the

agency promulgating the rule must

submit a rule report, which includes a

copy of the rule, to each House of the

Congress and to the Comptroller General

of the United States. EPA will submit a

report containing this rule and other

required information to the U.S. Senate,

the U.S. House of Representatives, and

the Comptroller General of the United

States prior to publication of the rule in

the Federal Register. This rule is not a

‘‘major rule’’ as defined by 5 U.S.C.

804(2).

List of Subjects in 40 CFR Part 180

Environmental protection,

Administrative practice and procedure,

Agricultural commodities, Pesticides

and pests, Reporting and recordkeeping

requirements.

Dated: June 24, 1998.

Peter Caulkins,

Acting Director, Registration Division, Office

of Pesticide Programs.

Therefore, 40 CFR Chapter I is

amended as follows:
37286 Federal Register / Vol. 63, No. 132 / Friday, July 10, 1998 /Rules and Regulations

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 § 180.442, by amending the table

under paragraph (b) by revising the

entry for ‘‘Raspberries’’ to read as

follows:

§ 180.442 Bifenthrin; tolerances for

residues.

* * * * *

(b) * * *

Commodity Parts per

million

Expiration/

Revocation

Date

* * * * * * *

Raspberries ....... 3.0 12/31/99

* * * * * * *

* * * * *

[FR Doc. 98–18279 Filed 7–9–98; 8:45 am]

BILLING CODE 6560–50–F

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Part 180

[OPP–300665; FRL–5794–3]

RIN 2070–AB78

Gliocladium Catenulatum Strain J1446;

Exemption from the Requirement of a

Tolerance

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Final rule.

SUMMARY: This rule establishes an

exemption from the requirement of a

tolerance for residues of the biological

pesticide Gliocladium catenulatum

strain J1446 in or on all agricultural

commodities. Kemira Agro Oy

submitted a petition to EPA under the

Federal Food, Drug and Cosmetic Act as

amended by the Food Quality Protection

Act of 1996 requesting the tolerance

exemption. This regulation eliminates

the need to establish a maximum

permissible level for residues of

Gliocladium catenulatum strain J1446.

DATES: This regulation is effective July

10, 1998. Objections and requests for

hearings must be received by EPA on or

before September 8, 1998.

ADDRESSES: Written objections and

hearing requests, identified by the

docket control number [OPP–300665],

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 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–300665],

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 be submitted electronically by

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

electronic objections and hearing

requests must be submitted as an ASCII

file avoiding the use of special

characters and any form of encryption.

Copies of electronic objections and

hearing requests will also be accepted

on disks in WordPerfect 5.1/6.1 file

format or ASCII file format. All copies

of electronic objections and hearing

requests must be identified by the

docket number [OPP–300665]. No

Confidential Business Information (CBI)

should be submitted through e-mail.

Copies of electronic objections and

hearing requests on this rule may be

filed online at many Federal Depository

Libraries.

FOR FURTHER INFORMATION CONTACT: By

mail: Susanne Cerrelli, c/o Product

Manager (PM) 90, Biopesticides and

Pollution Prevention Division (7511C),

Office of Pesticide Programs,

Environmental Protection Agency, 401

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

Office location and telephone number,

and e-mail address: CM #2 Rm. 902

W48, 1921 Jefferson Davis Hwy.,

Arlington, VA, (703) 308–8077, e-mail

address:

cerrelli.susanne@epamail.epa.gov.

SUPPLEMENTARY INFORMATION: In the

Federal Register of June 25, 1997 (62 FR

34271)(FRL–5721–7), EPA issued a

notice pursuant to section 408(d), of the

Federal Food, Drug and Cosmetic Act

(FFDCA), 21 U.S.C. 346a(d), announcing

the filing of a pesticide tolerance

petition by Kemira Agro Oy (PP

7F4137). The notice contained a

summary of the petition prepared by the

petitioner and this summary contained

conclusions and arguments to support

its conclusion that the petition

complied with the Food Quality

Protection Act (FQPA) of 1996. The

petition requested that 40 CFR part 180

be amended by establishing an

exemption from the requirement of a

tolerance for residues of the biological

pest control agent Gliocladium

catenulatum strain J1446. There were

no comments received in response to

the notice of filing.

The data submitted in the petition

and other material have been evaluated.

The toxicology data requirements in

support of this exemption from the

requirement of a tolerance were satisfied

via submitted data.

I. Risk Assessment and Statutory

Findings

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

FFDCA allows EPA to establish an

exemption from the requirement for a

tolerance (the legal limit for a pesticide

chemical residue in or on a food) only

if EPA determines that the tolerance is

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

‘‘safe’’ to mean that ‘‘there is a

reasonable certainty that no harm will

result from aggregate exposure to the

pesticide chemical residue, including

all anticipated dietary exposures and all

other exposures for which there is

reliable information.’’ This includes

exposure through drinking water and in

residential settings, but does not include

occupational exposure. Section

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

consideration to exposure of infants and

children to the pesticide chemical

residue 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...’’ Additionally,

section 408(b)(2)(D)(v) requires that the

Agency consider ‘‘available

information’’ concerning the cumulative

effects of a particular pesticide’s

residues and ‘‘other substances that

have a common mechanism of toxicity.’’

EPA performs a number of analyses to

determine the risks from aggregate

exposure to pesticide residues. First,

EPA determines the toxicity of

pesticides. Second, EPA examines

exposure to the pesticide through food,

drinking water, and through other

exposures that occur as a result of

pesticide use in residential settings.

II. Toxicological Profile

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

of FFDCA, EPA has reviewed the