42678 Federal Register / Vol. 62, No. 153 / Friday, August 8, 1997 / Rules and Regulations

Dated: August 1, 1997.

Richard C. Vlaun,

Captain, U.S. Coast Guard, Captain of the

Port, New York.

[FR Doc. 97–21030 Filed 8–7–97; 8:45 am]

BILLING CODE 4910–14–M

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Part 180

[OPP–300517; FRL–5731–7]

RIN 2070–AB78

Herbicide Safener HOE–107892;

Pesticide Tolerances for Emergency

Exemptions

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Final rule.

SUMMARY: This regulation establishes a

time-limited tolerance for the inert

ingredient, herbicide safener HOE–

107892 (mefenpyr-diethyl) and its 2,4-

dichlorophenyl-pyrazoline metabolites

HOE–094270 and HOE–113225 in or on

wheat grain and wheat straw. 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 herbicide safener

on wheat grain and wheat straw in

North Dakota and Montana. This

regulation establishes a maximum

permissible level for residues of the

Herbicide safener HOE–107892 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

tolerances will expire and are revoked

on August 1, 1998.

DATES: This regulation is effective

August 8, 1997. Objections and requests

for hearings must be received by EPA on

or before October 7, 1997.

ADDRESSES: Written objections and

hearing requests, identified by the

docket control number, [OPP–300517],

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–

300517], must also be submitted to:

Public Information and Records

Integrity Branch, Information Resources

and Services Division (7506C), Office of

Pesticide Programs, Environmental

Protection Agency, 401 M St., SW.,

Washington, DC 20460. In person, bring

a copy of objections and hearing

requests to Rm. 1132, CM #2, 1921

Jefferson Davis 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 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–

300517]. 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: Pat Cimino, 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) 308-9357, e-mail:

cimino.pat@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

tolerances for the inert ingredient

herbicide safener HOE–107892

(mefenpyr-diethyl) and its 2,4-

dichlorophenyl-pyrazoline metabolites

HOE–094270 and HOE–113225 in or on

wheat grain and wheat straw at 0.01 and

0.05 ppm respectively. These tolerances

will expire and are revoked on August

1, 1998. 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 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.
Federal Register / Vol. 62, No. 153 / Friday, August 8, 1997 / Rules and Regulations 42679

II. Emergency Exemption for Herbicide

Safener HOE–107892 (mefenpyrdiethyl) on Wheat Grain and Wheat

Straw and FFDCA Tolerances

The North Dakota and Montana State

Departments of Agriculture requested

the use of PUMA 1EC Herbicide for

control of green and yellow foxtail

(pigeon grass) in durum wheat in North

Dakota and Montana. The active

ingredient in PUMA 1EC is fenoxapropethyl which has tolerances established

for uses on wheat. However,

fenoxaprop-ethyl is phytotoxic to

durum wheat without the addition of an

inert ingredient safener. The herbicide

safener HOE–107892 allows the active

ingredient, fenoxaprop-ethyl, to control

yellow and green foxtail without

harming the durum wheat. Although

HOE–107892 (mefenpyr-diethyl) is an

inert ingredient, tolerances for residues

from its use on foods/feeds are required

by the FFDCA. EPA has authorized

under FIFRA section 18 the use of the

Herbicide safener HOE–107892 on

wheat grain and wheat straw for control

of green and yellow foxtail (pigeon

grass) in North Dakota and Montana.

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

the Herbicide safener HOE–107892 in or

on wheat grain and wheat straw. 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 August 1,

1998, under FFDCA section 408(l)(5),

residues of the pesticide not in excess

of the amounts specified in the

tolerance remaining in or on wheat

grain and wheat straw 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 Herbicide safener HOE–107892

meets EPA’s registration requirements

for use on wheat grain and wheat straw

or whether permanent tolerances for

this use would be appropriate. Under

these circumstances, EPA does not

believe that these tolerances serve as a

basis for registration of Herbicide

safener HOE–107892 by a State for

special local needs under FIFRA section

24(c). Nor do these tolerances serve as

the basis for any States other than North

Dakota and Montana 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 Herbicide safener HOE–

107892, 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

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
42680 Federal Register / Vol. 62, No. 153 / Friday, August 8, 1997 / Rules and Regulations

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 3 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 the Herbicide safener HOE–

107892 and to make a determination on

aggregate exposure, consistent with

section 408(b)(2), for a time-limited

tolerance for HOE–107892 and its 2,4-

dichlorophenyl-pyrazoline metabolites

HOE–094270 and HOE–113225 on

wheat grain and wheat straw at 0.01 and

0.05 ppm respectively. 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

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 Herbicide safener

HOE–107892 are discussed below.

1. Acute toxicity. The Agency

recommended using the NOEL of 100

milligrams per kilogram per day (mg/kg/

day) based on abortions and fetal

intrauterine deaths without

morphological developmental effects, at

the lowest effect level (LEL) of 250 mg/

kg/day from the rabbit developmental

study. This NOEL is used to evaluate

the Margin of Exposure (MOE) from the

acute dietary risk to pregnant women

13+ years or older.

2. Short - and intermediate - term

toxicity. No short- or intermediate-term

non-dietary, non-occupational exposure

scenario exists for HOE–107892 because

no uses currently exist for the safener

and only agricultural uses are requested

for these section 18s.

3. Chronic toxicity. For purposes of

this section 18 request use only, EPA

has established the RfD for Herbicide

safener HOE–107892 at 0.01 mg/kg/day.

The temporary RfD is based on the

chronic toxicity/carcinogenicity study

in mice with a NOEL of 3.0 mg/kg/day

(20 ppm) and an uncertainty factor of

300 (due to the absence of full

evaluation of the toxicology data base).

At the LEL of 1.5 mg/kg/day (100 ppm),

dose-related hepatocellular hypertrophy

was present in male mice.

4. Carcinogenicity. The mouse and rat

cancer studies with the safener have not

been reviewed and classified by the

Agency. Perusal of the cancer studies by

the Agency indicates no identifiable

cancer concern in the mouse study.

However, a possible concern regarding

the increased incidence of thyroid

follicular cell adenomas and carcinomas

combined at the highest dose tested of

5,000 ppm in the rat carcinogenicity

study was identified. This study

requires an in-depth review by the

Agency. Until that time, it is not known

if a cancer risk assessment is required or

what method of quantification would be

appropriate. Therefore, for purposes of

these Section 18s, a cancer risk

assessment will not be conducted.
Federal Register / Vol. 62, No. 153 / Friday, August 8, 1997 / Rules and Regulations 42681

B. Exposures and Risks

1. From food and feed uses. No

permanent tolerances have been

established for the inert ingredient

herbicide safener HOE–107892. There

are no indoor or outdoor residential

uses registered for the safener. Risk

assessments were conducted by EPA to

assess dietary exposures and risks from

Herbicide safener HOE–107892 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 one day or single exposure. The acute

dietary exposure endpoints of concern

for the herbicide safener HOE–107892

are abortions and fetal intrauterine

deaths without morphological

developmental effects, which were

observed in the rabbit developmental

study. The population subgroup of

concern is pregnant females 13+ years

old. Acute dietary exposure (food only)

was calculated using the high end

exposure value and TMRC (worst case)

assumptions. Therefore, this risk

assessment is considered conservative.

Despite the potential for acute exposure

to the herbicide safener HOE–107892 in

drinking water, EPA does not expect the

aggregate acute exposure to exceed the

Agency’s level of concern.

ii. Chronic exposure and risk. In

conducting exposure assessments for

these section 18 requests, EPA used

tolerance level residues and assumed

that 100% of the crop would be treated

with the pesticide (TMRC worst-case

analysis assumptions) as described

above.

2. From drinking water. The Agency’s

Environmental Fate data base indicates

that HOE–107892 is persistent in the

environment and has little potential for

soil mobility or leaching.

Because the Agency lacks sufficient

water-related exposure data to complete

a comprehensive drinking water risk

assessment for many pesticides, EPA

has commenced and nearly completed a

process to identify a reasonable yet

conservative bounding figure for the

potential contribution of water-related

exposure to the aggregate risk posed by

a pesticide. In developing the bounding

figure, EPA estimated residue levels in

water for a number of specific pesticides

using various data sources. The Agency

then applied the estimated residue

levels, in conjunction with appropriate

toxicological endpoints (RfD’s or acute

dietary NOEL’s) and assumptions about

body weight and consumption, to

calculate, for each pesticide, the

increment of aggregate risk contributed

by consumption of contaminated water.

While EPA has not yet pinpointed the

appropriate bounding figure for

exposure from contaminated water, the

ranges the Agency is continuing to

examine are all below the level that

would cause Herbicide safener HOE–

107892 to exceed the RfD if the

tolerance being considered in this

document were granted. The Agency

has therefore concluded that the

potential exposures associated with

Herbicide safener HOE–107892 in

water, even at the higher levels the

Agency is considering as a conservative

upper bound, would not prevent the

Agency from determining that there is a

reasonable certainty of no harm if the

tolerance is granted.

3. 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

Herbicide safener HOE–107892 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, Herbicide

safener HOE–107892 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 Herbicide safener

HOE–107892 has a common mechanism

of toxicity with other substances.

C. Aggregate Risks and Determination of

Safety for U.S. Population

1. Acute risk. As discussed above, the

acute dietary exposure endpoint of

concern for HOE–107892 is abortions

and fetal intrauterine deaths which were

observed in the rabbit developmental

toxicology study. For the U.S.

populations subgroup of concern,

females of childbearing age (13+ years

old) , an MOE value of 10,000 was

calculated using the high end human

exposure value of 0.00006 mg/kg/day.

The Agency generally considers MOEs

over 100 acceptable. This acute dietary

(food only) risk assessment used

tolerance level residues and assumed

100% crop-treated (TMRC worst-case

analysis, described above). Despite the

potential for risk from acute exposure to

HOE–107892 in drinking water, the

Agency does not expect acute aggregate

exposure to exceed its level of concern.

EPA concludes that there is reasonable

certainty that no harm will result from

acute aggregate exposure to HOE–

107892.

2. Chronic risk. Using the

conservative TMRC exposure

assumptions described above, EPA has

concluded that aggregate exposure to

Herbicide safener HOE–107892 from

food will utilize less than 0.01% of the

RfD for the U.S. population and all

population subgroups, including infants

and children. EPA generally has no

concern for exposures below 100% of

the RfD because the RfD represents the
42682 Federal Register / Vol. 62, No. 153 / Friday, August 8, 1997 / Rules and Regulations

level at or below which daily aggregate

dietary exposure over a lifetime will not

pose appreciable risks to human health.

Despite the potential for exposure to

Herbicide safener HOE–107892 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 from aggregate

exposure to Herbicide safener HOE–

107892 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.

Because no short- or intermediateterm non-dietary, non-occupational

exposure scenario exists for HOE–

107892, a short- or intermediate-term

aggregate risk assessment is not

required.

D. Aggregate Risks and Determination of

Safety for Infants and Children

1. Safety factor for infants and

children—a. In general. In assessing the

potential for additional sensitivity of

infants and children to residues of

Herbicide safener HOE–107892, 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 pesticide exposure

during prenatal development to one or

both parents. Reproduction studies

provide information relating to effects

from exposure to the pesticide on the

reproductive capability of mating

animals and data on systemic toxicity.

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.

b. Developmental toxicity studies. In

the rat developmental toxicity study, the

maternal (systemic) NOEL was 1,000

mg/kg/day (highest dose tested). The

developmental (pup) NOEL was 1,000

mg/kg/day (highest dose tested).

In the rabbit developmental toxicity

study, the maternal (systemic) NOEL of

100 mg/kg/day, was based on decreased

body weight gain and food

consumption, and abortions in the does

at the LOEL of 250 mg/kg/day. The

developmental (pup) NOEL was 100

mg/kg/day, based on intrauterine deaths

of fetuses without morphological

developmental effects at 250 mg/kg/day.

c. Reproductive toxicity study. In the

rat reproduction study, the parental

(systemic) NOEL was 75 mg/kg/day,

based on decreased food consumption,

body weight, increased spleen weights

and increased splenic hematopoiesis at

the LOEL of 396 mg/kg/day. The

reproductive/developmental (pup)

NOEL was 75 mg/kg/day, based on

decreased body weight at the LEL of 396

mg/kg/day.

d. Pre- and post-natal sensitivity. The

rabbit developmental study indicates a

concern for pre-natal sensitivity for

infants and children and an acute

dietary risk assessment was required

(discussed below, under acute risk) for

pregnant females 13+ years of age. The

results of the rat developmental study

do not indicate any concerns for prenatal sensitivity for infants and

children. Both the maternal and

developmental NOELs were 1,000 mg/

kg/day (highest dose tested).

The results of the rat reproduction

study did not demonstrate any concerns

for post-natal sensitivity for infants and

children. The parental and pup NOELs

were both 75 mg/kg/day and at the

LOELs of 396 mg/kg/day, the decrease

in body weight in the pups was also

seen in the parental animals.

e. Conclusion. Based on current

toxicological data requirements, the data

base for developmental and

reproductive studies for HOE–107892 is

complete. The Agency concluded that

the developmental and reproductive

findings in rats did not demonstrate any

pre-natal or post-natal acute risk

concerns for infants and children. The

Agency concluded that the observed

developmental effects in the rabbit

study present a pre-natal acute risk

concern for infants and children and

that an acute risk assessment was

required to evaluate a margin of

exposure . The acute risk assessment is

described in detail below.

2. Acute risk. The Agency concluded

that the observed developmental effects

in the rabbit study, abortions and fetal

intrauterine death, present a pre-natal

acute risk concern for infants and

children. An acute dietary risk

assessment evaluating margin of

exposure (MOE) for women of

childbearing age (13+ years old) is

required when the Agency determines

that there is a pre- or post- natal acute

risk effect of concern. The acute dietary

MOE for women of childbearing age is

10,000 based on the rabbit

developmental NOEL of 100 mg/kg/day

and the high end human exposure value

of 0.00006 mg/kg/day. This MOE is

much higher than the minimal

acceptable MOE of 100 for acute

exposure to food. Despite the potential

for acute exposure to HOE–107892 in

drinking water, the Agency does not

expect acute aggregate exposure to

exceed it level of concern. EPA

concludes that there is a reasonable

certainty that no harm will result to

infants and children from aggregate

exposure to HOE–107892.

3. Chronic risk. Using the

conservative exposure assumptions

described above, EPA has concluded

that aggregate exposure to Herbicide

safener HOE–107892 from food will

utilize less than 0.01% of the RfD for

infants and children. EPA generally has

no concern for exposures below 100%

of the RfD because the RfD represents

the level at or below which daily

aggregate dietary exposure over a

lifetime will not pose appreciable risks

to human health. Despite the potential

for exposure to Herbicide safener HOE–

107892 in drinking water and from nondietary, 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 Herbicide safener HOE–

107892 residues.

4. Short- or intermediate-term risk.

Because no short- or intermediate-term

non-dietary, non-occupational exposure

scenario exists for HOE–107892, a shortor intermediate-term aggregate risk

assessment is not required.

V. Other Considerations

A. Metabolism In Plants and Animals

For purposes of the Section 18 use

only, the nature of the residue for HOE–

107892 in wheat is adequately

understood. HOE–094270 was the major

residue identified in grain, and HOE–

094270 and HOE–113225 were the
Federal Register / Vol. 62, No. 153 / Friday, August 8, 1997 / Rules and Regulations 42683

major residues identified in straw. The

residues of concern are HOE–107892

and its metabolites HOE–094270 and

HOE–113225.

Because of the lack of quantifiable

residues in wheat grain and straw, even

at exaggerated treatment rates (up to

6.4x), and considering that this use is

only for durum wheat, for purposes of

this section 18 use only, the Agency will

assume that there will be no

quantifiable residues of the safener

HOE–107892 or its metabolites in milk,

meat, poultry or eggs resulting from this

use.

The maximum theoretical

concentration factors for wheat bran and

shorts are 7.7 and 8.4x respectively.

Because residues in wheat grain treated

at the 6.4x rate were nondetectable (less

than 0.01 ppm), for purposes of this

section 18 use only, the Agency will

assume that residues in processed wheat

commodities will also be nondetectable

(less than 0.01 ppm).

B. Analytical Enforcement Methodology

For purposes of this Section 18 use

only, adequate enforcement

methodology is available to quantify

HOE–107892 and major metabolites in

wheat grain and straw.

C. Magnitude of Residues

Combined residues of HOE–107892 ,

HOE–094270 and HOE–113225 are not

expected to exceed 0.01 ppm in wheat

grain and 0.05 ppm in wheat straw as

a result of this Section 18 use.

Secondary residues of HOE–107892 are

not expected in animal commodities

associated with this Section 18 use.

D. International Residue Limits

Italy has established a maximum

residue limit (MRL) of 0.05 ppm in or

on wheat grain for residues of HOE–

109782.

VI. Conclusion

Therefore, tolerances are established

for HOE–107892 (mefenpyr-diethyl) and

its 2,4-dichlorophenyl-pyrazoline

metabolites HOE–094270 and HOE–

113225 in wheat grain and wheat straw

at 0.01 and 0.05 ppm respectively.

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 October 7, 1997,

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 Docket

EPA has established a record for this

rulemaking under docket control

number [OPP–300517] (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 1132 of the Public Information

and Records Integrity Branch,

Information Resources and Services

Division (7506C), 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 a tolerance

under FFDCA section 408(d) in

response to a petition 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).
42684 Federal Register / Vol. 62, No. 153 / Friday, August 8, 1997 / Rules and Regulations

In addition, since these tolerances and

exemptions that are established on the

basis of a petition under FFDCA section

408 (d), 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

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: July 24, 1997.

James Jones,

Acting 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. Section 180.509 is added to read as

follows :

§ 180.509 HOE–107892 (mefenpyr-diethyl);

tolerance for residues.

(a) General. [Reserved]

(b) Section 18 emergency exemptions.

Time-limited tolerances are established

for residues of the herbicide safener

HOE–107892 (mefenpyr-diethyl) and its

2,4-dichlorophenyl-pyrazoline

metabolites HOE–094270 and HOE–

113225 in connection with use of the

herbicide safener under Section 18

emergency exemptions granted by the

EPA. The tolerances will expire and are

revoked on the dates specified in the

following table:

Commodity Parts per million Expiration/revocation date

Wheat grain ......................................................................................... 0.01 August 1, 1998

Wheat straw ......................................................................................... 0.05 August 1, 1998

(c) Tolerances with regional

registrations. [Reserved]

(d) Indirect or inadvertent residues.

[Reserved]

[FR Doc. 97–20844 Filed 8-7-97; 8:45 am]

BILLING CODE 6560–50–F

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Part 180

[OPP–300522 FRL–5732–9]

RIN 2070–AB78

Myclobutanil; Pesticide Tolerances for

Emergency Exemptions

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Final rule.

SUMMARY: This regulation establishes

time-limited tolerances for combined

residues of myclobutanil in or on

tomatoes . 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 tomatoes. This regulation

establishes a maximum permissible

level for residues of myclobutanil 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

July 28, 1998.

DATES: This regulation is effective

August 8, 1997. Objections and requests

for hearings must be received by EPA on

or before October 7, 1997.

ADDRESSES: Written objections and

hearing requests, identified by the

docket control number, [OPP–300522],

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–

300522], must also be submitted to:

Public Information and Records

Integrity Branch, Information Resources

and Services Division (7506C), Office of

Pesticide Programs, Environmental

Protection Agency, 401 M St., SW.,

Washington, DC 20460. In person, bring

a copy of objections and hearing

requests to Rm. 1132, CM #2, 1921

Jefferson Davis 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 file format

or ASCII file format. All copies of

objections and hearing requests in

electronic form must be identified by

the docket control number [OPP300522]. 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: Andrew Ertman, 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) 308-9367, e-mail:

ertman.andrew@epamail.epa.gov.