51032 Federal Register / Vol. 62, No. 189 / Tuesday, September 30, 1997 / Rules and Regulations

Dated: September 25, 1997.

Mary A. Ryan,

Assistant Secretary for Consular Affairs.

[FR Doc. 97–25951 Filed 9–29–97; 8:45 am]

BILLING CODE 4710–06–P

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Part 180

[OPP–300554; FRL–5744–8]

RIN 2070-AB78

Carfentrazone-ethyl; Temporary

Pesticide Tolerance

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Final rule.

SUMMARY: This regulation establishes a

temporary tolerance for combined

residues of the herbicide carfentrazoneethyl (ethyl-alpha-2-dichloro-5-[4-

(difluoromethyl)-4,5-dihydro-3-methyl5-oxo-1H-1,2,4-triazol-1-yl]-4-

fluorobenzenepropanoate) and its major

wheat metabolites in or on corn (fodder,

forage, and grain) and wheat (grain, hay,

and straw). FMC requested this

tolerance under the Federal Food, Drug,

and Cosmetic Act (FFDCA), as amended

by the Food Quality Protection Act of

1966 (Pub. L. 104–170).

DATES: This regulation is effective

September 30, 1997. Objections and

requests for hearings must be received

by EPA on or before December 1, 1997.

ADDRESSES: Written objections and

hearing requests, identified by the

docket control number, OPP–300554,

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–

300554], 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–300554.

No Confidential Business Information

(CBI) should be submitted through email. 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: Joanne I. Miller, Product Manager,

Registration Division (7505C), Office of

Pesticide Programs, Environmental

Protection Agency, 401 M St., SW.,

Washington, DC 20460. Office location,

telephone number, and e-mail address:

Crystal Mall #2, 1921 Jefferson Davis

Hwy., Arlington, VA, (703) 305–6224, email: miller.joanne@epamail.epa.gov.

SUPPLEMENTARY INFORMATION: In the

Federal Register of May 16, 1997 (62 FR

27040) (FRL–5717–4), EPA issued a

notice pursuant to section 408 of the

Federal Food, Drug, and Cosmetic Act

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

the filing of a pesticide petition (PP) for

tolerance by FMC Corporation, 1735

Market St., Philadelphia, PA 19103.

This notice included a summary of the

petition prepared by FMC Corporation,

the registrant. There were no comments

received in response to the notice of

filing. The petition requested that 40

CFR part 180 be amended by

establishing a temporary tolerance for

combined residues of the herbicide

carfentrazone-ethyl (ethyl-alpha-2-

dichloro-5-[4-(difluoromethyl)-4,5-

dihydro-3-methyl-5-oxo-1H-1,2,4-

triazol-1-yl]-4-

fluorobenzenepropanoate), and its

metabolite in or on field corn forage,

fodder, and grain at 0.15 ppm; and for

wheat hay, straw, and grain at 0.20 ppm

part per million (ppm). This tolerance

will expire on May 8, 1998. This

tolerance request was submitted along

with an application for an experimiental

use permit (EUP). The EUP proposed

the experimental use of carfentrazoneethyl on corn and wheat. Under FIFRA,

section 5 for experimental use permits,

a temporary tolerance level must be

established if a pesticide may

reasonably be expected to result in any

residue in or on food or feed use.

I. Risk Assessment and Statutory

Findings

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. . . .’’

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
Federal Register / Vol. 62, No. 189 / Tuesday, September 30, 1997 / Rules and Regulations 51033

the test animals, and that one person or

subgroup of the population (such as

infants and children) could be up to 10

times more sensitive to a pesticide than

another. In addition, EPA assesses the

potential risks to infants and children

based on the weight of the evidence of

the toxicology studies and determines

whether an additional uncertainty factor

is warranted. Thus, an aggregate daily

exposure to a pesticide residue at or

below the RfD (expressed as 100 percent

or less of the RfD) is generally

considered acceptable by EPA. EPA

generally uses the RfD to evaluate the

chronic risks posed by pesticide

exposure. For shorter term risks, EPA

calculates a margin of exposure (MOE)

by dividing the estimated human

exposure into the NOEL from the

appropriate animal study. Commonly,

EPA finds MOEs lower than 100 to be

unacceptable. This 100-fold MOE is

based on the same rationale as the 100-

fold uncertainty factor.

Lifetime feeding studies in two

species of laboratory animals are

conducted to screen pesticides for

cancer effects. When evidence of

increased cancer is noted in these

studies, the Agency conducts a weight

of the evidence review of all relevant

toxicological data including short-term

and mutagenicity studies and structure

activity relationship. Once a pesticide

has been classified as a potential human

carcinogen, different types of risk

assessments (e.g., linear low dose

extrapolations or MOE calculation based

on the appropriate NOEL) will be

carried out based on the nature of the

carcinogenic response and the Agency’s

knowledge of its mode of action.

2. Differences in toxic effect due to

exposure duration. The toxicological

effects of a pesticide can vary with

different exposure durations. EPA

considers the entire toxicity data base,

and based on the effects seen for

different durations and routes of

exposure, determines which risk

assessments should be done to assure

that the public is adequately protected

from any pesticide exposure scenario.

Both short and long durations of

exposure are always considered.

Typically, risk assessments include

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

term,’’ and ‘‘chronic’’ risks. These

assessments are defined by the Agency

as follows.

Acute risk, by the Agency’s definition,

results from 1–day consumption of food

and water, and reflects toxicity which

could be expressed following a single

oral exposure to the pesticide residues.

High end exposure to food and water

residues are typically assumed.

Short-term risk results from exposure

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

and therefore overlaps with the acute

risk assessment. Historically, this risk

assessment was intended to address

primarily dermal and inhalation

exposure which could result, for

example, from residential pesticide

applications. However, since enaction of

FQPA, this assessment has been

expanded to include both dietary and

non-dietary sources of exposure, and

will typically consider exposure from

food, water, and residential uses when

reliable data are available. In this

assessment, risks from average food and

water exposure, and high-end

residential exposure, are aggregated.

High-end exposures from all three

sources are not typically added because

of the very low probability of this

occurring in most cases, and because the

other conservative assumptions built

into the assessment assure adequate

protection of public health. However,

for cases in which high-end exposure

can reasonably be expected from

multiple sources (e.g. frequent and

widespread homeowner use in a

specific geographical area), multiple

high-end risks will be aggregated and

presented as part of the comprehensive

risk assessment/characterization. Since

the toxicological endpoint considered in

this assessment reflects exposure over a

period of at least 7 days, an additional

degree of conservatism is built into the

assessment; i.e., the risk assessment

nominally covers 1-7 days exposure,

and the toxicological endpoint/NOEL is

selected to be adequate for at least 7

days of exposure. (Toxicity results at

lower levels when the dosing duration

is increased.)

Intermediate-term risk results from

exposure for 7 days to several months.

This assessment is handled in a manner

similar to the short-term risk

assessment.

Chronic risk assessment describes risk

which could result from several months

to a lifetime of exposure. For this

assessment, risks are aggregated

considering average exposure from all

sources for representative population

subgroups including infants and

children.

B. Aggregate Exposure

In examining aggregate exposure,

FFDCA section 408 requires that EPA

take into account available and reliable

information concerning exposure from

the pesticide residue in the food in

question, residues in other foods for

which there are tolerances, residues in

groundwater or surface water that is

consumed as drinking water, and other

non-occupational exposures through

pesticide use in gardens, lawns, or

buildings (residential and other indoor

uses). Dietary exposure to residues of a

pesticide in a food commodity are

estimated by multiplying the average

daily consumption of the food forms of

that commodity by the tolerance level or

the anticipated pesticide residue level.

The Theoretical Maximum Residue

Contribution (TMRC) is an estimate of

the level of residues consumed daily if

each food item contained pesticide

residues equal to the tolerance. In

evaluating food exposures, EPA takes

into account varying consumption

patterns of major identifiable subgroups

of consumers, including infants and

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

estimate since it is based on the

assumptions that food contains

pesticide residues at the tolerance level

and that 100% of the crop is treated by

pesticides that have established

tolerances. If the TMRC exceeds the RfD

or poses a lifetime cancer risk that is

greater than approximately one in a

million, EPA attempts to derive a more

accurate exposure estimate for the

pesticide by evaluating additional types

of information (anticipated residue data

and/or percent of crop treated data)

which show, generally, that pesticide

residues in most foods when they are

eaten are well below established

tolerances.

Percent of crop treated estimates are

derived from federal and private market

survey data. Typically, a range of

estimates are supplied and the upper

end of this range is assumed for the

exposure assessment. By using this

upper end estimate of percent of crop

treated, the Agency is reasonably certain

that exposure is not understated for any

significant subpopulation group.

Further, regional consumption

information is taken into account

through EPA’s computer-based model

for evaluating the exposure of

significant subpopulations including

several regional groups, to pesticide

residues. For this pesticide, the most

highly exposed population subgroup

(non-nursing infants <1 year old) was

not regionally based.

II. 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 carfentrazone-ethyl and to

make a determination on aggregate

exposure, consistent with section

408(b)(2), for a temporary tolerance for

combined residues of carfentrazoneethyl (ethyl-alpha-2-dichloro-5-[4-
51034 Federal Register / Vol. 62, No. 189 / Tuesday, September 30, 1997 / Rules and Regulations

(difluoromethyl)-4,5-dihydro-3-methyl5-oxo-1H-1,2,4-triazol-1-yl]-4-

fluorobenzenepropanoate) and its

metabolites on wheat at 0.20 ppm and

corn at 0.15 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 carfentrazoneethyl are discussed below.

1. A battery of acute toxicity studies

placed technical carfentrazone in

Toxicity Categories III and IV. No

evidence of sensitization was observed

following dermal application in guinea

pigs.

2. A 90–day subchronic toxicity study

was conducted in rats, with dietary

intake levels of 58, 226, 4,700, 831 and

1,197 milligrams/kilograms/day (mg/kg/

day) in males and 72, 284, 578, 1,008

and 1,427 mg/kg/day in females,

respectively. A NOEL of 226 mg/kg/day

(males) and 5,778 mg/kg/day (females)

was established. LOELs of 470 mg/kg/

day (males) and 578 mg/kg/day

(females) was established based on

decreases in body weights and/or gains,

reductions in food consumption,

alterations in clinical chemistry

parameters, and histopathological

lesions.

3. A reverse gene mutation assay

(salmonella typhirmurium) yielded

negative results, both with and without

metabolic activation.

4. An in vitro mutation assay test

yielded negative results, there was no

indication of an increased incidence of

gene mutation at the HGPRT locus as a

result of exposure.

5. An in vitro mammalian cytogenetic

test yielded positive under nonactivated

conditions in this assay.

6. An in vivo micronucleus

cytogenetic assay study was conducted

in mice by IP injection of 600, 1,200 and

2,400 mg/kg to groups of five males and

five females. There was no indication of

an increased incidence in

micronucleated polychromatic

erythrocytes associated with exposure to

the test material.

7. A 13–week study was conducted on

four pure breed Beagle dogs/sex/group

for 90 days at dietary intake levels of 0,

50, 150, 500 and 1,000 mg/kg/day.

NOELs of 500 mg/kg/day for both sexes

and the LOEL of 150 mg/kg/day, based

on systemic toxicity (decrease in the

rate of weight gain in females and an

increase in porphyrin levels in both

sexes).

8. An oral prenatal developmental

study was administered by gavage to

pregnant female New Zealand white

rabbits (20/group) on days 7-19 of

gestation at dose levels of 0, 10, 40, 150,

or 300 mg/kg/day. There was no

evidence of treatment-related prenatal

developmental toxicity. The

developmental LOEL was not

determined. The developmental NOEL ≥

of 300 mg/kg/day.

B. Toxicological Endpoints

1. Acute toxicity. The Agency does

not have a concern for an acute dietary

assessment since the available data do

not indicate any evidence of significant

toxicity from a 1 day or single event

exposure by the oral route, therefore an

acute (food and water) risk assessment

was not required.

2. Chronic toxicity. EPA has

established the RfD for carfentrazoneethyl at 0.06 mg/kg/day. This RfD is

based on the NOEL of 60 mg/kg/day

from a 90–day rat study with a 1,000

fold uncertainty factor.

3. Carcinogenicity. No concern for

cancer risks were identified. Data from

available studies do not indicate a

treatment-related tumor problem, and

cancer risk endpoints have not been

identified.

C. Exposures and Risks

1. From food and feed uses.

Tolerances have not yet been

established for the combined residues of

carfentrazone-ethyl (ethyl-alpha-2-

dichloro-5-[4-(difluoromethyl)-4,5-

dihydro-3-methyl-5-oxo-1H-1,2,4-

triazol-1-yl]-4-

fluorobenzenepropanoate), and its

metabolites, in or on a variety of raw

agricultural commodities. Due to the

non-quantifiable carfentrazone-ethyl

residues in/on the treated RAC’s (except

wheat forage, however, there is a label

feeding restriction) fed to livestock and

the limited number of acres involved,

there is no expectation of secondary

residues in livestock commodities of

meat, meat-by-products, fat, milk, and

eggs. Risk assessments were conducted

by EPA to assess dietary exposures and

risks from carfentrazone-ethyl 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. No short and

intermediate endpoints for occupational

and residential exposure were

identified.

ii. Chronic exposure and risk. The

chronic dietary analysis indicates that

exposure from the proposed temporary

tolerances for use of carfentrazone-ethyl

in/on corn and wheat for the U.S.

population would account for less than

1% of the RfD. For children (1-6 years),

the subgroup with the highest exposure,

1% of the RfD would be utilized. This

chronic analysis for carfentrazone is an

upper-bound estimate of dietary

exposure with all residues at tolerance

level and assuming 100% of the

commodities to be treated. Since only

4,000 acres of wheat and 4,000 acres of

corn will be treated under the EUP

program (which represents less than 1%

of the total wheat and corn harvested in

the United States, this dietary analysis

represents an over estimate of the

percent RfD that will be utilized by the

proposed temporary tolerances.

Therefore, the chronic dietary risk

resulting from the proposed temporary

tolerances for carfentrazone-ethyl will

not exceed the Agency’s level of

concern.

2. From drinking water. A chronic

dietary risk assessment from drinking

water was not conducted because of the

short duration of the EUP (2 years) and

the small percentage of treated acres for

corn and wheat as a result of the

proposed use (<1% of the total U.S.

production for both commodities).

i. Acute exposure and risk. As part of

the hazard assessment process, the

Agency reviews the available

toxicological data base to determine the

endpoints of concern for acute dietary

risk. There is no concern since the

available data do not indicate any

evidence of significant toxicity from a 1

day or single event exposure by the oral

route. Therefore an acute dietary risk

assessment was not required.

ii. Chronic exposure and risk. Because

the Agency lacks sufficient waterrelated 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
Federal Register / Vol. 62, No. 189 / Tuesday, September 30, 1997 / Rules and Regulations 51035

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 carfentrazone-ethyl 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 carfentrazone-ethyl 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. From non-dietary exposure. The

proposed uses for this pesticide does

not include uses that would result in a

non-dietary, non-occupational exposure.

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

carfentrazone-ethyl 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, carfentrazoneethyl 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 carfentrazone-ethyl has a

common mechanism of toxicity with

other substances.

D. Aggregate Risks and Determination of

Safety for U.S. Population

1. Acute risk. The Agency does not

have a concern for acute dietary

assessment since the available data do

not indicate any evidence of significant

toxicity from a 1 day or single event

exposure by the oral route. An acute

dietary risk assessment was not

required.

2. Chronic risk. The chronic dietary

analysis indicates that exposure from

the proposed temporary tolerances for

use of carfentrazone-ethyl in/on corn

and wheat for the U.S. population

would account for less than 1% of the

RfD. For children (1-6 years), the

subgroup with the highest exposure, 1%

of the RfD would be utilized. A chronic

dietary risk (food and water) was not

conducted for the following reasons: the

short duration of the EUP, the small

percentage of treated acres for corn and

wheat as a result of the proposed use

(<1% of the total U.S. production for

both commodities; and the fact that

these commodities are blended before

consumption). This chronic analysis for

carfentrazone-ethyl is an upper-bound

estimate of dietary exposure with all

residues at tolerance level and assuming

100% of the commodities to be treated.

Since only 4,000 acres of wheat and

4,000 acres of corn will be treated under

the EUP program, which represents less

than 1% of the total wheat and corn

harvested in the United States, this

dietary analysis represents an over

estimate of the percent RfD that will be

utilized by the proposed temporary

tolerances. Therefore, the chronic

dietary risk resulting from the proposed

temporary tolerances for carfentrazoneethyl will not exceed the Agency’s level

of concern. EPA concludes that there is

a reasonable certainty that no harm will

result from aggregate exposure to

carfentrazone-ethyl residues.

E. Aggregate Cancer Risk for U.S.

Population

The chronic dietary analysis indicates

that exposure from the proposed

temporary tolerances for use of

carfentrazone-ethyl in/on corn and

wheat for the U.S. population would

account for less than 1% RfD. There is

no concern for cancer risks identified.

Data from available studies do not

indicate a treatment-related tumor

problem, and cancer endpoints have not

been identified.

F. 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

carfentrazone-ethyl, EPA considered

data from developmental toxicity

studies in the rat and rabbit.

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 10-fold 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 data base unless

EPA determines that a different margin

of safety will be safe for infants and

children. Margins of safety are

incorporated into EPA risk assessments

either directly through use of a 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
51036 Federal Register / Vol. 62, No. 189 / Tuesday, September 30, 1997 / Rules and Regulations

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. i. A

prenatal oral developmental toxicity

study in rabbits with dose levels of 0,

10, 40, 150, or 300 mg/kg/day with a

maternal LOEL of 300/mg/kg/day and

the maternal NOEL of ≥150 mg/kg/day.

There was not evidence of treatmentrelated prenatal developmental toxicity.

ii. A prenatal oral developmental

toxicity study in the rat at dose levels

of 0, 100, 600, or 1,250 mg/kg/day with

a maternal LOEL of 600 mg/kg/day

based on staining of the

abdominogential area and of the cage

pan liner; and with the maternal NOEL

of 100 mg/kg/day. The developmental

NOEL of 1,250 mg/kg/day was based

upon a significant increase in the litter

incidences of wavy and thickened ribs

and with the developmental NOEL of

600 mg/kg/day.

c. Reproductive toxicity study. Under

Title 40 of the Code of Federal

Regulations, part 158, § 158.340, a 2-

generation reproduction study is not

required for an EUP when the TMRC is

less than 50% of the RfD. Exposure from

the proposed temporary tolerance of

carafentrazone-ethyl from use on wheat

and corn will account for less than 1%

of the RfD.

d. Pre- and post-natal sensitivity.

There was no evidence of pre-and postnatal sensitivity in the prenatal oral

developmental studies discussed above.

e. Conclusion. All required toxicology

studies have been completed for this

phase of the registration process. The

required developmental studies show

no pre-natal sensitivity. Based on these

findings as well as the generally low

toxicity seen in all of the carfentrazone

studies, EPA concludes there is reliable

data supporting not using an additional

10-fold safety factor for the protection of

infants and children. EPA believes the

1,000-fold safety factor used in assessing

the carfentrazone risk is adequate to

protect all consumers. The 1,000-fold

safety factor includes a 100-fold factor

for intra- and inter-species differences

and a 10-fold factor because the RfD was

based on subchronic study.

2. Chronic risk. EPA has concluded

that aggregate exposure to

carfentrazone-ethyl from food will

utilize 1% 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

carfentrazone-ethyl in drinking water

and from non-dietary, non-occupational

exposure, EPA does not expect the

aggregate exposure to exceed 100% of

the RfD. EPA concludes that there is a

reasonable certainty that no harm will

result to infants and children from

aggregate exposure to carfentrazoneethyl residues.

III. Other Considerations

A. Metabolism in Plants and Animals

The metabolism of carfentrazoneethyl in plants is adequately understood

for the purposes of these tolerances. For

the purposes of the EUP, the residues of

concern are the parent carfentrazoneethyl and its two major metabolites. The

nature of the residue in animals has not

been reported. Due to the nonquantifiable carfentrazone-ethyl

residues in/on the treated RACs, except

wheat forage (there is a label feeding

restriction in the EUP) fed to livestock

and the limited number of acres

involved, there is no expectation of

secondary residues in livestock

commodities of meat, meat-by-products,

fat, milk, and eggs.

B. Analytical Enforcement Methodology

There is a practical analytical method

for detecting and measuring levels of

carfentrazone and its metabolites in or

on food with a limit of detection that

allows monitoring of food with residues

at or above the levels set in these

tolerances. The proposed analytical

method for determining residues is

hydrolysis followed by gas

chromatographic separation. For the

parent carfentrazone-ethyl, acceptable

method recoveries were established at a

limit of quantitation (LOQ) of 0.05 ppm,

and a limit of detection (LOD) was set

at 0.01 ppm for all the field corn and

wheat crop matrices. The methodology

can also be used to determine major

plant metabolites with similar LOQs

and LODs. No analytical method for

meat, milk and eggs has been submitted

by the registrant. Since no temporary

tolerances have been proposed for

animal RACs, an analytical enforcement

method for animals is not required for

the EUP.

C. Magnitude of Residues

The magnitude of the residue in

animals has not been reported. These

data will not be required for the EUP

due to the non-quantifiable

carfentrazone-ethyl residues in/on

treated RACs (corn forage, fodder, and

grain, and wheat hay, straw, and grain)

fed to livestock and the limited number

of acres involved. Residues were only

found in wheat forage, therefore for the

EUP only, a grazing restriction must be

included to prohibit the grazing and

harvesting of wheat forage as a feedstuff.

D. International Residue Limits

There is no Codex proposal, no

Canadian or Mexican limits for residues

of carfentrazone-ethyl in corn or wheat.

A compatibility issue is not relevant to

the proposed tolerances for either crop.

IV. Conclusion

Therefore, the temporary tolerance is

established for combined residues of

carfentrazone (ethyl-alpha-2-dichloro-5-

[4-(difluoromethyl)-4,5-dihydro-3-

methyl-5-oxo-1H-1,2,4-triazol-1-yl]-4-

fluorobenzenepropanoate) and its

metabolites in wheat at 0.20 ppm and

corn at 0.15 ppm.

V. 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 December 1,

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
Federal Register / Vol. 62, No. 189 / Tuesday, September 30, 1997 / Rules and Regulations 51037

that available evidence identified by the

requestor would, if established, resolve

one or more of such issues in favor of

the requestor, taking into account

uncontested claims or facts to the

contrary; and resolution of the factual

issues in the manner sought by the

requestor would be adequate to justify

the action requested (40 CFR 178.32).

Information submitted in connection

with an objection or hearing request

may be claimed confidential by marking

any part or all of that information as

CBI. Information so marked will not be

disclosed except in accordance with

procedures set forth in 40 CFR part 2.

A copy of the information that does not

contain CBI must be submitted for

inclusion in the public record.

Information not marked confidential

may be disclosed publicly by EPA

without prior notice.

VI. Public Docket

EPA has established a record for this

rulemaking under docket control

number OPP–300554 (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 Highway, Arlington, VA.

Electronic comments may be sent

directly to EPA at: oppdocket@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.

VII. Regulatory Assessment

Requirements

This final rule establishes a temporary

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).

In addition, since these tolerances and

exemptions that are established on the

basis of a petition under FFDCA section

408(d), such as the temporary 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.

VIII. 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: September 22, 1997.

Stephen L. Johnson,

Acting Director, Office of Pesticide Programs.

Therefore, 40 CFR Chapter I is

amended as follows:

PART 180—[AMENDED]

1. The authority citation for part 180

continues to read as follows:

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

2. By adding § 180.515, to read as

follows:

§ 180.515 Carfentrazone-ethyl; temporary

tolerances for residues.

(a) General. Temporary tolerances are

established for combined residues of the

herbicide carfentrazone-ethyl (ethylalpha-2-dichloro-5-[4-(difluoromethyl)-

4,5-dihydro-3-methyl-5-oxo-1H-1,2,4-

triazol-1-yl]-4-fluorobenzenepropanoate)

and its major wheat metabolites

carfentrazone-ethyl chloropropionic

acid (alpha,2-dichloro-5-[4-

difluoromethyl)-4,5-dihydro-3-methyl-5-

oxo-1H-1,2,4-triazol-1-yl]-4-

fluorobenzenepropanoic acid),3-

hydroxymethyl-F8426-chloropropionic

acid (alpha,2-dichloro-5-[4-

difluoromethyl)-4,5-dihydro-3-

hydroxymethyl-5-oxo-1H-1,2,4-triazol-1-

yl]-4-fluorobenzenepropanoic acid) and

3-desmethyl-F8426 chloropropionic

acid (alpha,2-dichloro-5-[4-

difluoromethyl)-4,5-dihydro-5-oxo-1H1,2,4-triazol-1-yl]-4-

fluorobenzenepropanoic acid) and in or

on the following food commodities:

Commodity Parts per

million

Expiration/

revocation

date

Corn fodder ....... 0.15 5/8/98

Corn forage ....... 0.15 5/8/98

Corn grain ......... 0.15 5/8/98

Wheat hay ......... 0.2 5/8/98

Wheat grain ....... 0.2 5/8/98

Wheat straw ...... 0.2 5/8/98

(b) Section 18 emergency exemptions.

[Reserved]

(c) Tolerances with regional

registrations. [Reserved]
51038 Federal Register / Vol. 62, No. 189 / Tuesday, September 30, 1997 / Rules and Regulations

(d) Indirect or inadvertent residues.

[Reserved]

[FR Doc. 97–25891 Filed 9–29–97; 8:45 am]

BILLING CODE 6560–50–F

DEPARTMENT OF TRANSPORTATION

Coast Guard

46 CFR Parts 1, 2, 4, 5, 10, 12, 24, 25,

26, 28, 30, 31, 32, 34, 35, 36, 39, 42, 44,

46, 54, 56, 58, 61, 62, 63, 64, 69, 76, 77,

92, 95, 96, 98, 107, 108, 109, 110, 111,

114, 115, 116, 117, 119, 122, 125, 147,

147A, 153, 154, 159, 160, 161, 162, 170,

171, 174, 175, 176, 177, 178, 180, 182,

183, 185, 188, 190, 193, 194, 195, and

199

[CGD 97–057]

Technical Amendments;

Organizational Changes;

Miscellaneous Editorial Changes and

Conforming Amendments

AGENCY: Coast Guard, DOT.

ACTION: Final rule.

SUMMARY: This rule amends Title 46,

Code of Federal Regulations to reflect

recent agency organizational changes. It

also makes editorial changes throughout

the title to correct addresses, update

cross-references, make conforming

amendments and make other technical

corrections. This rule will have no

substantive effect on the regulated

public.

EFFECTIVE DATE: This rule is effective on

September 30, 1997.

ADDRESSES: Unless otherwise indicated,

documents referred to in this preamble

are available for inspection or copying

at the office of the Executive Secretary,

Marine Safety Council (G–LRA/3406),

U.S. Coast Guard Headquarters, 2100

Second Street SW., room 3406,

Washington, DC 20593–0001 between

9:30 a.m. and 2 p.m., Monday through

Friday, except Federal holidays. The

telephone number is 202–267–1477.

FOR FURTHER INFORMATION CONTACT:

Janet Walton, Project Manager,

Standards Evaluation and Development

Division (G–MSR–2), 202–267–0257.

SUPPLEMENTARY INFORMATION:

Background and Purpose

Each year Title 46 of the Code of

Federal Regulations is recodified on

October 1. This rule makes

miscellaneous editorial changes,

conforming amendments, and revisions

relating to recent Coast Guard

organizational changes, to be included

in the 1997 recodification of Title 46.

Discussion of Changes

As part of its Headquarters

reorganization, the Coast Guard changed

senior management position titles from

‘‘Chief’’ to ‘‘Assistant Commandant’’ for

the Acquisition, Civil Rights, Marine

Safety and Environmental Protection,

Operations, and Systems and Human

Resources programs. This rule revises

the Marine Safety and Environmental

Protection title to conform to the current

organization.

The rule also makes editorial changes

throughout the title, corrects addresses,

updates cross-references, and makes

other technical corrections. This rule

does not change any substantive

requirements of existing regulations.

Sections 1.03–15, 1.03–30, 1.03–35, and

1.03–40

In sections 1.03–15((h) (2) and (3),

1.03–30 (a) and (b), and 1.03–35(a), the

Coast Guard revises the appeal process

concerning appeals to the Commandant

and to the Marine Safety Center

involving tonnage measurement; and

removes both paragraph (c) of section

1.03–35 and section 1.03–40.

Section 2.10–25

Section 2.10–25 revises the definition

for Offshore supply vessel or OSV to

conform to the definition published in

the Offshore Supply Vessels; Alternate

Tonnage final rule; interpretation (61 FR

66613), published on December 18,

1996.

Sections 24.10–17 and 25.30–20

In section 24.10–17 and Table 25.30–

20(a)(1), the Coast Guard removes

references to motorboat classes ‘‘A, 1, 2,

or 3’’ because the recreational boating

safety regulations no longer refer to

motorboat classes, but rely solely on

vessel length category.

Sections 69.15, 69.17, 69.19 and 69.23

In sections 69.15, 69.17, 69.19 and

69.23, the Coast Guard changes the term

‘‘Organizations authorized to measure

vessels’’ to ‘‘Authorized measurement

organizations’’ for tonnage measurement

and, in addition, makes available a

current listing of authorized

measurement organizations.

Section 69.63

This rule corrects a codification error,

and subsequent publication errors, that

dropped an element of the formula from

§ 69.63, Net tonnage.

Sections 98.30–4, 98.30–5, 98.33–3,

147.40, 147.45, and 147.A.11

The Coast Guard revises sections

98.30–4(a)(1), 98.30–5(a)(4), (b), and (e),

98.33–3 (a) and (b), 147.40 (a)(1) and

(a)(2), 147.45(f)(3), and

147A.11(b)(5)(iii) to conform to 49 CFR

Chapter I, Subchapter C (HAZARDOUS

MATERIALS REGULATIONS), and the

1990 comprehensive revision and

reorganization of that Subchapter.

Since this amendment relates to

departmental management,

organization, procedure, and practice,

notice and comment on it are

unnecessary and it may be made

effective in fewer than 30 days after

publication in the Federal Register.

Therefore, this final rule is effective on

September 30, 1997.

Regulatory Evaluation

This rule is not a significant

regulatory action under section 3(f) of

Executive Order 12866 and does not

require an assessment of potential costs

and benefits under section 6(a)(3) of that

order. It has not been reviewed by the

Office of Management and Budget under

that order. It is not significant under the

regulatory policies and procedures of

the Department of Transportation (DOT)

(44 FR 11040; February 26, 1979). The

Coast Guard expects the economic

impact of this rule to be so minimal that

a full Regulatory Evaluation under

paragraph 10e of the regulatory policies

and procedures of DOT is unnecessary.

As this rule involves internal agency

practices and procedures, it will not

impose any costs on the public.

Collection of Information

This rule contains no collection-ofinformation requirements under the

Paperwork Reduction Act (44 U.S.C.

3501 et seq.).

Federalism

The Coast Guard has analyzed this

rule under the principles and criteria

contained in Executive Order 12612 and

has determined that this rule does not

have sufficient federalism implications

to warrant the preparation of a

Federalism Assessment.

Environment

The Coast Guard considered the

environmental impact of this rule and

concluded that under paragraph 2.B.2 of

Commandant Instruction M16475.1B,

this rule is categorically excluded from

further environmental documentation.

This exclusion is in accordance with

paragraphs 2.B.2.e.(34) (a) and (b),

concerning regulations that are editorial

or procedural and concerning internal

agency functions or organization. A

‘‘Categorical Exclusion Determination’’

is available in the docket for inspection

or copying where indicated under

ADDRESSES.