Federal Register / Vol. 63, No. 150 /Wednesday, August 5, 1998 /Rules and Regulations 41727

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 tolerances

under FFDCA section 408(l)(6). The

Office of Management and Budget

(OMB) has exempted these types of

actions from review under Executive

Order 12866, entitled Regulatory

Planning and Review (58 FR 51735,

October 4, 1993). This final rule does

not contain any information collections

subject to OMB approval under the

Paperwork Reduction Act (PRA), 44

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

enforceable duty or contain any

unfunded mandate as described under

Title II of the Unfunded Mandates

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

104-4). Nor does it require any prior

consultation as specified by Executive

Order 12875, entitled Enhancing the

Intergovernmental Partnership (58 FR

58093, October 28, 1993), or special

considerations as required by Executive

Order 12898, entitled Federal Actions to

Address Environmental Justice in

Minority Populations and Low-Income

Populations (59 FR 7629, February 16,

1994), or require OMB review in

accordance with Executive Order 13045,

entitled Protection of Children from

Environmental Health Risks and Safety

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

In addition, since these tolerances and

exemptions that are established under

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

tolerances in this final rule, do not

require the issuance of a proposed rule,

the requirements of the Regulatory

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

seq.) do not apply. Nevertheless, the

Agency has previously assessed whether

establishing tolerances, exemptions

from tolerances, raising tolerance levels

or expanding exemptions might

adversely impact small entities and

concluded, as a generic matter, that

there is no adverse economic impact.

The factual basis for the Agency’s

generic certification for tolerance

acations published on May 4, 1981 (46

FR 24950), and was provided to the

Chief Counsel for Advocacy of the Small

Business Administration.

X. Submission to Congress and the

Comptroller General

The Congressional Review Act, 5

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

Business Regulatory Enforcement

Fairness Act of 1996, generally provides

that before a rule may take effect, the

agency promulgating the rule must

submit a rule report, which includes a

copy of the rule, to each House of the

Congress and to the Comptroller General

of the United States. EPA will submit a

report containing this rule and other

required information to the U.S. Senate,

the U.S. House of Representatives, and

the Comptroller General of the United

States prior to publication of the rule in

the Federal Register. This rule is not a

‘‘major rule’’ as defined by 5 U.S.C.

804(2).

List of Subjects in 40 CFR Part 180

Environmental protection,

Administrative practice and procedure,

Agricultural commodities, Pesticides

and pests, Reporting and recordkeeping

requirements.

Dated: July 16, 1998.

James Jones,

Director, Registration Division, Office of

Pesticide Programs.

Therefore, 40 CFR chapter I is

amended as follows:

PART 180–[AMENDED]

1. The authority citation for part 180

continues to read as follows:

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

2. Section 180.511 is amending

paragraph (b) by alphabetically adding

the following entries to the table to read

as follows:

§ 180.511 Buprofezin; tolerances for

residues

* * * * *

(b) * * *

Commodity Parts per

million

Expiration/

Revocation

Date

* * * * *

Cucurbits ........... 0.5 12/31/99

* * * * *

Tomatoes .......... 0.7 12/31/99

Tomato paste .... 1.0 12/31/99

* * * * *

[FR Doc. 98–20906 Filed 8–4–98; 8:45 am]

BILLING CODE 6560–50–F

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Part 180

[OPP–300688; FRL–6018–4]

RIN 2070–AB78

Fluroxypyr 1-Methylheptyl Ester;

Pesticide Tolerances for Emergency

Exemptions

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Final rule.

SUMMARY: This regulation establishes

time-limited tolerances for the

combined residues of fluroxypyr 1-

methylheptyl ester and its metabolite

fluroxypyr in or on wheat, barley, field

corn, and sweet corn. This action is in

response to EPA’s granting of emergency

exemptions under section 18 of the

Federal Insecticide, Fungicide, and

Rodenticide Act authorizing use of the

pesticide on wheat, barley, field corn,

and sweet corn. This regulation

establishes a maximum permissible

level for residues of fluroxypyr 1-

methylheptyl ester and its metabolite

fluroxypyr in these food commodities

pursuant to section 408(l)(6) of the

Federal Food, Drug, and Cosmetic Act,

as amended by the Food Quality

Protection Act of 1996. These tolerances

will expire and are revoked on

December 1, 1999.

DATES: This regulation is effective

August 5, 1998. Objections and requests

for hearings must be received by EPA on

or before October 5, 1998.

ADDRESSES: Written objections and

hearing requests, identified by the

docket control number, [OPP–300688],

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–

300688], must also be submitted to:

Public Information and Records

Integrity Branch, Information Resources

and Services Division (7502C), Office of

Pesticide Programs, Environmental

Protection Agency, 401 M St., SW.,

Washington, DC 20460. In person, bring

a copy of objections and hearing

requests to Rm. 119, CM #2, 1921

Jefferson Davis Hwy., Arlington, VA.
41728 Federal Register / Vol. 63, No. 150 /Wednesday, August 5, 1998 /Rules and Regulations

A copy of objections and hearing

requests filed with the Hearing Clerk

may also be submitted electronically by

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

objections and hearing requests must be

submitted as an ASCII file avoiding the

use of special characters and any form

of encryption. Copies of objections and

hearing requests will also be accepted

on disks in WordPerfect 5.1/6.1 file

format or ASCII file format. All copies

of objections and hearing requests in

electronic form must be identified by

the docket control number [OPP–

300688]. 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.

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 combined residues of

the herbicide fluroxypyr 1-methylheptyl

ester and its metabolite fluroxypyr, in or

on wheat and barley, grain at 0.5 parts

per million (ppm); wheat, forage at 12.0

ppm; wheat and barley, hay at 20.0

ppm; wheat and barley, straw at 12.0

ppm; aspirated grain fractions at 0.6

ppm; corn, sweet, K + CWHR at 0.05

ppm; corn, sweet, forage at 2.0 ppm;

corn, sweet, stover at 2.5 ppm; corn,

field, grain at 0.05 ppm; corn, field,

forage at 2.0 ppm; corn, field, stover at

2.5 ppm; meat, fat, and meat byproducts

(except kidney) of cattle, goats, hogs,

horses, and sheep 0.1 ppm; kidney of

cattle, goats, hogs, horses, and sheep 0.5

ppm; milk 0.1 ppm. These tolerances

will expire and are revoked on

December 1, 1999. EPA will publish a

document in the Federal Register to

remove the revoked tolerances from the

Code of Federal Regulations.

I. Background and Statutory Authority

The Food Quality Protection Act of

1996 (FQPA) (Pub. L. 104–170) was

signed into law August 3, 1996. FQPA

amends both the Federal Food, Drug,

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

301 et seq., and the Federal Insecticide,

Fungicide, and Rodenticide Act

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

amendments went into effect

immediately. Among other things,

FQPA amends FFDCA to bring all EPA

pesticide tolerance-setting activities

under a new section 408 with a new

safety standard and new procedures.

These activities are described below and

discussed in greater detail in the final

rule establishing the time-limited

tolerance associated with the emergency

exemption for use of propiconazole on

sorghum (61 FR 58135, November 13,

1996)(FRL–5572–9).

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

FFDCA allows EPA to establish a

tolerance (the legal limit for a pesticide

chemical residue in or on a food) only

if EPA determines that the tolerance is

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

‘‘safe’’ to mean that ‘‘there is a

reasonable certainty that no harm will

result from aggregate exposure to the

pesticide chemical residue, including

all anticipated dietary exposures and all

other exposures for which there is

reliable information.’’ This includes

exposure through drinking water and in

residential settings, but does not include

occupational exposure. Section

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

consideration to exposure of infants and

children to the pesticide chemical

residue in establishing a tolerance and

to ‘‘ensure that there is a reasonable

certainty that no harm will result to

infants and children from aggregate

exposure to the pesticide chemical

residue. . . .’’

Section 18 of FIFRA authorizes EPA

to exempt any Federal or State agency

from any provision of FIFRA, if EPA

determines that ‘‘emergency conditions

exist which require such exemption.’’

This provision was not amended by

FQPA. EPA has established regulations

governing such emergency exemptions

in 40 CFR part 166.

Section 408(l)(6) of the FFDCA

requires EPA to establish a time-limited

tolerance or exemption from the

requirement for a tolerance for pesticide

chemical residues in food that will

result from the use of a pesticide under

an emergency exemption granted by

EPA under section 18 of FIFRA. Such

tolerances can be established without

providing notice or period for public

comment.

Because decisions on section 18-

related tolerances must proceed before

EPA reaches closure on several policy

issues relating to interpretation and

implementation of the FQPA, EPA does

not intend for its actions on such

tolerance to set binding precedents for

the application of section 408 and the

new safety standard to other tolerances

and exemptions.

II. Emergency Exemption for

Fluroxypyr 1-Methylheptyl Ester on

Wheat, Barley, Field Corn, and Sweet

Corn and FFDCA Tolerances

Fluroxypyr 1-methylheptyl ester was

requested to control volunteer potatoes.

It was stated that volunteer potatoes are

one of the main sources for

overwintering of obligate pests of

potatoes including late blight and

leafroll virus. The populations of

volunteer potatoes are closely related to

the severity of winter temperature

conditions. When soil temperatures

reach levels low enough to freeze tubers

remaining in the soil after harvest,

volunteer potatoes are generally not a

problem. However, following mild

winters, volunteer potatoes are always

present in crops following potatoes in

the rotation. Sustained temperatures of

28°F or less are required to kill the

tubers and prevent emergence of

volunteers.

The applicants stated that volunteer

potato populations will be high in 1998

and that volunteer potato plants will act

as a source of infection from both late

blight and leafroll virus. EPA has

authorized under FIFRA section 18 the

use of fluroxypyr 1-methylheptyl ester

on wheat, barley, field corn, and sweet

corn for control of volunteer potatoes in

Idaho, Michigan, Montana, Washington

and kochia in North Dakota, and South

Dakota. After having reviewed the

submission, 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

fluroxypyr 1-methylheptyl ester in or on

wheat, barley, field corn, and sweet

corn. In doing so, EPA considered the

new safety standard in FFDCA section

408(b)(2), and EPA decided that the

necessary tolerances under FFDCA

section 408(l)(6) would be consistent

with the new safety standard and with

FIFRA section 18. Consistent with the

need to move quickly on the emergency

exemption in order to address an urgent

non-routine situation and to ensure that

the resulting food is safe and lawful,

EPA is issuing these tolerances without

notice and opportunity for public

comment under section 408(e), as

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

these tolerances will expire and are

revoked on December 1, 1999, under

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

pesticide not in excess of the amounts

specified in the tolerances remaining in

or on wheat, barley, field corn, and

sweet corn after that date will not be

unlawful, provided the pesticide is

applied in a manner that was lawful
Federal Register / Vol. 63, No. 150 /Wednesday, August 5, 1998 /Rules and Regulations 41729

under FIFRA, and the residues do not

exceed a level that was authorized by

this tolerance at the time of that

application. EPA will take action to

revoke these tolerances earlier if any

experience with, scientific data on, or

other relevant information on this

pesticide indicate that the residues are

not safe.

Because these tolerances are being

approved under emergency conditions

EPA has not made any decisions about

whether fluroxypyr 1-methylheptyl

ester meets EPA’s registration

requirements for use on wheat, barley,

field corn, and sweet corn or whether

permanent tolerances for these uses

would be appropriate. Under these

circumstances, EPA does not believe

that these tolerances serve as a basis for

registration of fluroxypyr 1-

methylheptyl ester by a State for special

local needs under FIFRA section 24(c).

Nor do these tolerances serve as the

basis for any State other than Idaho,

Michigan, Montana, Washington, North

Dakota, and South Dakota to use this

pesticide on these crops under section

18 of FIFRA without following all

provisions of section 18 as identified in

40 CFR part 166. For additional

information regarding the emergency

exemption for fluroxypyr 1-

methylheptyl ester, 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

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.
41730 Federal Register / Vol. 63, No. 150 /Wednesday, August 5, 1998 /Rules and Regulations

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.

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 fluroxypyr 1-methylheptyl

ester and to make a determination on

aggregate exposure, consistent with

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

tolerances for combined residues of

fluroxypyr 1-methylheptyl ester and its

metabolite fluroxypyr on wheat and

barley, grain at 0.5 ppm; wheat, forage

at 12.0 ppm; wheat and barley, hay at

20.0 ppm; wheat and barley, straw at

12.0 ppm; aspirated grain fractions at

0.6 ppm; corn, sweet, K + CWHR at 0.05

ppm; corn, sweet, forage at 2.0 ppm;

corn, sweet, stover at 2.5 ppm; corn,

field, grain at 0.05 ppm; corn, field,

forage at 2.0 ppm; corn, field, stover at

2.5 ppm; meat, fat, and meat byproducts

(except kidney) of cattle, goats, hogs,

horses, and sheep 0.1 ppm; kidney of

cattle, goats, hogs, horses, and sheep 0.5

ppm; milk 0.1 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 fluroxypyr 1-

methylheptyl ester are discussed below.

1. Acute toxicity. For acute dietary

risk assessment, the Agency is using a

NOEL of 100 milligrams/kilogram/day

(mg/kg/day), based on developmental

effects (postimplantation loss) at the

lowest effect level (LEL) of 250 mg/kg/

day, from a developmental study in

rabbits. This risk assessment will

evaluate acute dietary risk to females

13+ years, the population subgroup of

concern. An MOE of 300 is required

because of FQPA considerations.

2. Short - and intermediate - term

toxicity. For short and intermediateterm risk assessment, the Agency is

using a NOEL of 100 mg/kg/day, based

on developmental effects

(postimplantation loss) at the LEL of 250

mg/kg/day, from a developmental study

in rabbits. An MOE of 300 is required

because of FQPA considerations.

3. Chronic toxicity. EPA has

established the RfD for fluroxypyr 1-

methylheptyl ester at 0.50 mg/kg/day.

The RfD was established based on a 4-

week range finding study in dogs with

a NOEL of 50 mg/kg/day and an

uncertainty factor of 100 based on

histopathological lesions in the kidneys,

decreased testes weight, and increased

adrenal weight at the LEL of 150 mg/kg/

day.

4. Carcinogenicity. Fluroxypyr has

been classified as a ‘‘not likely’’

carcinogenic chemical by the Agency.

B. Exposures and Risks

1. From food and feed uses. No

tolerances have been established for

residues of fluroxypyr 1-methylheptyl

ester. Risk assessments were conducted

by EPA to assess dietary exposures and

risks from fluroxypyr 1-methylheptyl

ester 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 (food only) risk assessment used

the TMRC. The exposure estimate for

females (13+ years) results in a dietary

(food only) MOE of 50,000. This should

be viewed as a conservative risk

estimate; refinement using anticipated

residue values and percent crop-treated

data in conjunction with Monte Carlo

analysis would result in a lower acute

dietary exposure estimate.

ii. Chronic exposure and risk. In

conducting this chronic dietary risk

assessment, EPA has made very

conservative assumptions -- 100% of

wheat, barley, field corn, and sweet corn

and all other commodities having

fluroxypyr 1-methylheptyl ester

tolerances will contain fluroxypyr 1-

methylheptyl ester residues and those

residues would be at the level of the

tolerance -- which result in an

overestimation of human dietary

exposure. Thus, in making a safety

determination for this tolerance, HED is

taking into account this conservative

exposure assessment.

The existing fluroxypyr 1-

methylheptyl ester tolerances

(published, pending, and including the

necessary section 18 tolerances) result

in a TMRC that is equivalent to the

following percentages of the RfD:

Population Subgroup %RfD

U.S. Population (48 States) ...... 0.41%

U.S. Population - Fall Season .. 0.43%

U.S. Population - Winter Season ......................................... 0.43%

Northeast Region ...................... 0.43%

North Central Region ................ 0.43%

Western Region ........................ 0.44%

Hispanics .................................. 0.48%
Federal Register / Vol. 63, No. 150 /Wednesday, August 5, 1998 /Rules and Regulations 41731

Population Subgroup %RfD

Non-Hispanic Whites ................ 0.42%

Non-Hispanic Others ................ 0.43%

Nursing Infants (<1 year old) .... 0.39%

Non-Nursing Infants (<1 year

old) ........................................ 1.55%

Children (1-6 years old) ............ 1.06%

Children (7-12 years old) .......... 0.69%

Males (13-19 years old) ............ 0.46%

The subgroups listed above are: (1)

the U.S. population (48 states); (2) those

for infants and children; and, (3) the

other subgroups for which the

percentage of the RfD occupied is

greater than that occupied by the

subgroup U.S. population (48 states).

2. From drinking water. In terrestrial

and aquatic environments, fluroxypyr 1-

methylheptyl ester is rapidly

hydrolyzed to fluroxypyr. Fluroxypyr is

further degraded (although less rapidly)

by microbes to 4-amino-3,5-dichloro-6-

fluoro-pyridin-2-ol (‘‘pyridinol’’) and 4-

amino-3,5-dichloro-6-fluoro-2-

methoxypyridine (‘‘methoxypyridine’’).

In aerobic environments, fluroxypyr,

pyridinol, and methoxypyridine are

ultimately degraded to carbon dioxide.

There are no established Maximum

Contaminant Levels for residues of

fluroxypyr 1-methylheptyl ester in

drinking water. No health advisory

levels for fluroxypyr 1-methylheptyl

ester in drinking water have been

established.

The assessment used SCI-GROW2 for

groundwater assessment and GENEEC

Version 1.2 for acute and chronic

surface water assessments. Estimated

environmental concentrations (EEC’s) in

surface water reflecting 0.25 lb acid

equivalents/A/yr applied by air were

11.2 μg/L for acute and 3.9 μg/L for

chronic. EEC’s for groundwater were

0.025 μg/L parts per billion (ppb) for

acute and chronic. The computer

generated EECs represent conservative

estimates and should be used only for

screening.

i. Acute exposure and risk. OPP has

calculated drinking water levels of

concern (DWLOCs) for acute exposure

to fluroxypyr in drinking water for the

only relevant population subgroup,

females (13+ years): 9,930 μg/L.

To calculate the DWLOCs for acute

exposure relative to an acute toxicity

endpoint, the acute dietary food

exposure (from the DRES analysis) was

subtracted from the ratio of the acute

NOEL (used for acute dietary

assessments) to the acceptable MOE for

aggregate exposure to obtain the

acceptable acute exposure to

thiafluamide in drinking water.

DWLOCs were then calculated using

default body weights and drinking water

consumption figures.

Estimated maximum concentrations

of fluroxypyr in surface and ground

water are 11.2 ppb and 0.025 ppb,

respectively and the DWLOC is 9,930

μg/L. The estimated maximum

concentrations of fluroxypyr in surface

and ground water are less than OPP’s

level of concern for fluroxypyr in

drinking water as a contribution to acute

aggregate exposure.

Therefore, taking into account present

uses and uses proposed in this action,

OPP concludes with reasonable

certainty that residues of fluroxypyr in

drinking water (when considered along

with other sources of exposure for

which OPP has reliable data) would not

result in unacceptable levels of

aggregate human health risk at this time.

ii. Chronic exposure and risk. The

‘‘Interim Guidance for Conducting

Drinking Water Exposure and Risk

Assessments’’ issued on 24-NOV-1997

was followed for this assessment. Thus,

the GENEEC model and the SCI-GROW

model were run to produce estimates of

fluroxypyr concentrations in surface

and ground water, respectively. The

primary use of these models is to

provide a coarse screen for sorting out

pesticides for which OPP has a high

degree of confidence that the true levels

of the pesticide in drinking water will

be less than the human health drinking

water levels of concern (DWLOCs). A

DWLOC is the concentration of a

pesticide in drinking water which

would be acceptable as an upper limit

in light of total aggregate exposure to

that chemical from food, water, and

non-occupational (residential) sources.

The DWLOCchronic is the concentration

in drinking water as a part of the

aggregate chronic exposure that

occupies no more than 100% of the RfD.

The Agency’s default body weights and

water consumption values used to

calculate DWLOCs are as follows: 70 kg/

2L (adult male), 60 kg/2L (adult female),

and 10 kg/1L (child).

For chronic (non-cancer) exposure to

fluroxypyr in surface and ground water,

the drinking water levels of concern are

17,400 μg/L for the U.S. population,

14,900 μg/L for females (13+ years), and

4,950 μg/L for children (1-6 yrs). To

calculate the DWLOC for chronic (noncancer) exposure relative to a chronic

toxicity endpoint, the chronic dietary

food exposure (from DRES) was

subtracted from the RfD to obtain the

acceptable chronic (non-cancer)

exposure to fluroxypyr in drinking

water. DWLOCs were then calculated

using default body weights and drinking

consumption figures.

Estimated average concentrations of

fluroxypyr in surface and ground water

are 3.9 ppb and 0.025 ppb, respectively.

The DWLOCs are 17,400 μg/L for the

U.S. population, 14,900 μg/L for females

(13+ years), and 4,950 μg/L for children

(1-6 yrs). The estimated average

concentrations of fluroxypyr in surface

and ground water are less than OPP’s

level of concern for fluroxypyr in

drinking water as a contribution to

chronic aggregate exposure.

3. From non-dietary exposure. There

are no registered or proposed residential

uses for fluroxypyr 1-methylheptyl ester

or fluroxypyr.

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
41732 Federal Register / Vol. 63, No. 150 /Wednesday, August 5, 1998 /Rules and Regulations

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

fluroxypyr 1-methylheptyl ester 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, fluroxypyr 1-

methylheptyl ester 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 fluroxypyr 1-

methylheptyl ester has a common

mechanism of toxicity with other

substances.

C. Aggregate Risks and Determination of

Safety for U.S. Population

1. Acute risk. For the population

subgroup of concern, females 13+ years,

the calculated Margin of Exposure

(MOE) value (food) is 50,000. The

Agency acknowledges the potential for

exposure to fluroxypyr 1-methylheptyl

ester in drinking water, but does not

expect that exposure would result in an

aggregate MOE (food plus water) that

would exceed the Agency’s level of

concern for acute dietary exposure.

2. Chronic risk. Using the TMRC

exposure assumptions described above,

EPA has concluded that aggregate

exposure to fluroxypyr 1-methylheptyl

ester from food will utilize 0.41% of the

RfD for the U.S. population. The major

identifiable subgroup with the highest

aggregate exposure is discussed below.

EPA generally has no concern for

exposures below 100% of the RfD

because the RfD represents the level at

or below which daily aggregate dietary

exposure over a lifetime will not pose

appreciable risks to human health.

Despite the potential for exposure to

fluroxypyr 1-methylheptyl ester 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 fluroxypyr 1-methylheptyl

ester residues.

3. Short- and intermediate-term risk.

Short- and intermediate-term aggregate

exposure takes into account chronic

dietary food and water (considered to be

a background exposure level) plus

indoor and outdoor residential

exposure. There are no proposed

residential uses for fluroxypyr.

Therefore, the short and intermediate

aggregate risks are adequately addressed

by the chronic aggregate dietary risk

assessment.

D. Aggregate Cancer Risk for U.S.

Population

Fluroxypyr has been classified as a

‘‘not likely’’ carcinogenic chemical by

the Agency.

E. Aggregate Risks and Determination of

Safety for Infants and Children

1. Safety factor for infants and

children— i. In general. In assessing the

potential for additional sensitivity of

infants and children to residues of

fluroxypyr 1-methylheptyl ester, EPA

considered data from developmental

toxicity studies in the rat and rabbit and

a two-generation reproduction study in

the rat. This is generally the case -- edit

if different studies. The developmental

toxicity studies are designed to evaluate

adverse effects on the developing

organism resulting from maternal

pesticide exposure during gestation.

Reproduction studies provide

information relating to effects from

exposure to the pesticide on the

reproductive capability of mating

animals and data on systemic toxicity.

FFDCA section 408 provides that EPA

shall apply an additional 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 margin

of exposure analysis or through using

uncertainty (safety) factors in

calculating a dose level that poses no

appreciable risk to humans. In either

case, EPA generally defines the level of

appreciable risk as exposure that is

greater than 1/100 of the no observed

effect level in the animal study

appropriate to the particular risk

assessment. This 100-fold uncertainty

(safety) factor/margin of exposure

(safety) is designed to account for interspecies extrapolation and intra-species

variability. HED believes that reliable

data support using the 100-fold margin/

factor, rather than the 1,000-fold

margin/factor, when EPA has a

complete data base under existing

guidelines, and when the severity of the

effect in infants or children, the potency

or unusual toxic properties of a

compound, or the quality of the

exposure data do not raise concerns

regarding the adequacy of the standard

margin/factor.

ii. Developmental toxicity studies. In

the developmental study in rats, the

maternal (systemic) NOEL was 125 mg/

kg/day, based on clinical signs at the

lowest observed effect level (LOEL) of

250 mg/kg/day. The developmental

(fetal) NOEL was 250 mg/kg/day, based

on reduced ossification at the LOEL of

500 mg/kg/day.

In the developmental toxicity study in

rabbits, the maternal (systemic) NOEL

was 250 mg/kg/day, based on maternal

deaths at the LOEL of 400 mg/kg/day.

The developmental (pup) NOEL was

125 mg/kg/day, based on increased

postimplantation loss at the LOEL of

250 mg/kg/day.

iii. Reproductive toxicity study. In the

2-generation reproductive toxicity study

in rats, the maternal (systemic) NOEL

was 100 mg/kg/day, based on increased

kidney weights and kidney

histopathology at the LOEL of 500 mg/

kg/day. The developmental (pup) NOEL

was 500 mg/kg/day, based on decreased

body weight at the LOEL of 1,000 mg/

kg/day. The reproductive NOEL was

1,000 mg/kg/day HDT.

iv. Pre- and post-natal sensitivity. The

toxicological data base for evaluating

pre- and post-natal toxicity for

fluroxypyr is complete with respect to

current data requirements. Based on the

results of the rabbit developmental

toxicity study for fluroxypyr there does

appear to be an extra sensitivity for prenatal effects.

v. Conclusion. Based on the above,

EPA concludes that reliable data

support use of a 300-fold margin of

exposure/uncertainty factor, rather than

the standard 1000-fold margin/factor, to

protect infants and children.

2. Acute risk. The acute dietary MOE

(food) was calculated to be 6,666 for

infants (<1 year), 10,000 for children (1-

6 years), and 50,000 females 13+ years

(accounts for both maternal and fetal

exposure). These MOE calculations

were based on the developmental NOEL

in rabbits of 100 mg/kg/day. This risk

assessment assumed 100% crop-treated

with tolerance level residues on all

treated crops consumed, resulting in a

significant over estimation of dietary

exposure. The large acute dietary MOE

calculated for females 13+ years and the

infants <1 year subgroup (lowest MOE)

provides assurance that there is a

reasonable certainty of no harm for

females 13+ years, infants, and children.

EPA acknowledges the potential for

exposure to fluroxypyr 1-methylheptyl

ester in drinking water, but does not

expect that exposure would result in

aggregate MOEs (food plus water) that
Federal Register / Vol. 63, No. 150 /Wednesday, August 5, 1998 /Rules and Regulations 41733

would exceed the Agency’s level of

concern for acute dietary exposure.

3. Chronic risk. Using the

conservative exposure assumptions

described above, EPA has concluded

that aggregate exposure to fluroxypyr 1-

methylheptyl ester from food ranges

from 0.39% of the RfD for nursing

infants (<1 year old) up to 1.55% of the

RfD for non-nursing infants (<1 year

old). 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

fluroxypyr 1-methylheptyl ester 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

fluroxypyr 1-methylheptyl ester

residues.

4. Short- or 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 uses.

There are no proposed residential uses

for fluroxypyr. Therefore, the short and

intermediate aggregate risks are

adequately addressed by the chronic

aggregate dietary risk assessment.

V. Other Considerations

A. Metabolism In Plants and Animals

The nature of the residue in plants

and animals is adequately understood.

The residues of concern in plants and

animals are fluroxypyr 1-methylheptyl

ester and its metabolite fluroxypyr, free

and conjugated, all expressed as

fluroxypyr.

B. Analytical Enforcement Methodology

Adequate enforcement methodology

is available for plants (GC/MS and

capillary gas chromatography/MS) to

enforce the tolerance expression. The

petitioner validated the limit of

quantitation at 0.01 ppm for cereal

grains and 0.05 ppm for forage, straw,

and hay of cereal grains.

Adequate enforcement methodology

is available for livestock (GC/ECD and

capillary gas chromatography with mass

selective detection) to enforce the

tolerance expression. The petitioner

validated the limit of quantitation of

Method GRM 96.03 at 0.01 ppm for all

animal substrates.

C. Magnitude of Residues

Residues of fluroxypyr 1-

methylheptyl ester and fluroxypyr are

not expected to exceed the following

levels in RAC’s and processed

commodities of wheat, barley, sweet

corn, field corn, and animal

commodities as a result of this section

18 use. For this section 18 only, EPA

will permit the sweet corn residue data

to be translated to field corn.

Commodity Parts per

million

Aspirated grain fractions ........... 0.6 ppm

Corn, field, forage ..................... 2.0 ppm

Corn, field, grain ....................... 0.05 ppm

Corn, field, stover ..................... 2.5 ppm

Corn, sweet, forage .................. 2.0 ppm

Corn, sweet, K + CWHR .......... 0.05 ppm

Corn, sweet, stover ................... 2.5 ppm

Kidney of cattle, goats, hogs,

horses, and sheep ................ 0.5 ppm

Meat, fat, and meat byproducts

(except kidney) of cattle,

goats, hogs, horses, and

sheep ..................................... 0.1 ppm

Milk ............................................ 0.1 ppm

Wheat and barley, grain ........... 0.5 ppm

Wheat and barley, hay ............. 20.0 ppm

Wheat and barley, straw ........... 12.0 ppm

Wheat, forage ........................... 12.0 ppm

D. International Residue Limits

There are no CODEX, Canadian, or

Mexican tolerances for residues of

fluoroxypyr 1-methylheptyl ester on

wheat, barley, sweet corn, or field corn.

E. Rotational Crop Restrictions

A confined rotational crop study was

conducted in which fluroxypyr was

applied at the rate of 8.8 oz ae/A.

Residues in crops planted 120 days after

soil treatment were 0.01 to 0.08 ppm;

however, based on this study and the

section 18 use rates, residues of

fluroxypyr 1-methylheptyl ester and

fluroxypyr are not expected to occur in

rotational crops at levels >0.01 ppm at

the 120-day plant-back interval. The

statement ‘‘Observe a 120-day plantback interval’’ is needed on the Section

18 label, based on the confined

rotational crop study.

VI. Conclusion

Therefore, the tolerance is established

for combined residues of fluroxypyr 1-

methylheptyl ester and its metabolite

fluroxypyr in wheat and barley, grain at

0.5 ppm; wheat, forage at 12.0 ppm;

wheat and barley, hay at 20.0 ppm;

wheat and barley, straw at 12.0 ppm;

aspirated grain fractions at 0.6 ppm;

corn, sweet, K + CWHR at 0.05 ppm;

corn, sweet, forage at 2.0 ppm; corn,

sweet, stover at 2.5 ppm; corn, field,

grain at 0.05 ppm; corn, field, forage at

2.0 ppm; corn, field, stover at 2.5 ppm;

meat, fat, and meat byproducts (except

kidney) of cattle, goats, hogs, horses,

and sheep 0.1 ppm; kidney of cattle,

goats, hogs, horses, and sheep 0.5 ppm;

milk 0.1 ppm.

VII. Objections and Hearing Requests

The new FFDCA section 408(g)

provides essentially the same process

for persons to ‘‘object’’ to a tolerance

regulation issued by EPA under new

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 5, 1998,

file written objections to any aspect of

this regulation and may also request a

hearing on those objections. Objections

and hearing requests must be filed with

the Hearing Clerk, at the address given

above (40 CFR 178.20). A copy of the

objections and/or hearing requests filed

with the Hearing Clerk should be

submitted to the OPP docket for this

rulemaking. The objections submitted

must specify the provisions of the

regulation deemed objectionable and the

grounds for the objections (40 CFR

178.25). Each objection must be

accompanied by the fee prescribed by

40 CFR 180.33(i). If a hearing is

requested, the objections must include a

statement of the factual issues on which

a hearing is requested, the requestor’s

contentions on such issues, and a

summary of any evidence relied upon

by the requestor (40 CFR 178.27). A

request for a hearing will be granted if

the Administrator determines that the

material submitted shows the following:

There is genuine and substantial issue

of fact; there is a reasonable possibility

that available evidence identified by the

requestor would, if established, resolve

one or more of such issues in favor of

the requestor, taking into account

uncontested claims or facts to the

contrary; and resolution of the factual

issues in the manner sought by the

requestor would be adequate to justify

the action requested (40 CFR 178.32).

Information submitted in connection

with an objection or hearing request

may be claimed confidential by marking

any part or all of that information as

CBI. Information so marked will not be

disclosed except in accordance with
41734 Federal Register / Vol. 63, No. 150 /Wednesday, August 5, 1998 /Rules and Regulations

procedures set forth in 40 CFR part 2.

A copy of the information that does not

contain CBI must be submitted for

inclusion in the public record.

Information not marked confidential

may be disclosed publicly by EPA

without prior notice.

VIII. Public Record and Electronic

Submissions

EPA has established a record for this

rulemaking under docket control

number [OPP–300688] (including any

comments and data submitted

electronically). A public version of this

record, including printed, paper

versions of electronic comments, which

does not include any information

claimed as CBI, is available for

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

Monday through Friday, excluding legal

holidays. The public record is located in

Room 119 of the Public Information and

Records Integrity Branch, Information

Resources and Services Division

(7502C), Office of Pesticide Programs,

Environmental Protection Agency,

Crystal Mall #2, 1921 Jefferson Davis

Highway, Arlington, VA.

Electronic comments may be sent

directly to EPA at:

opp-docket@epamail.epa.gov.

Electronic comments must be

submitted as an ASCII file avoiding the

use of special characters and any form

of encryption.

The official record for this

rulemaking, as well as the public

version, as described above will be kept

in paper form. Accordingly, EPA will

transfer any copies of objections and

hearing requests received electronically

into printed, paper form as they are

received and will place the paper copies

in the official rulemaking record which

will also include all comments

submitted directly in writing. The

official rulemaking record is the paper

record maintained at the Virginia

address in ‘‘ADDRESSES’’ at the

beginning of this document.

IX. Regulatory Assessment

Requirements

This final rule establishes tolerances

under FFDCA section 408(l)(6). The

Office of Management and Budget

(OMB) has exempted these types of

actions from review under Executive

Order 12866, entitled Regulatory

Planning and Review (58 FR 51735,

October 4, 1993). This final rule does

not contain any information collections

subject to OMB approval under the

Paperwork Reduction Act (PRA), 44

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

enforceable duty or contain any

unfunded mandate as described under

Title II of the Unfunded Mandates

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

104-4). Nor does it require any prior

consultation as specified by Executive

Order 12875, entitled Enhancing the

Intergovernmental Partnership (58 FR

58093, October 28, 1993), or special

considerations as required by Executive

Order 12898, entitled Federal Actions to

Address Environmental Justice in

Minority Populations and Low-Income

Populations (59 FR 7629, February 16,

1994), or require OMB review in

accordance with Executive Order 13045,

entitled Protection of Children from

Environmental Health Risks and Safety

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

In addition, since these tolerances and

exemptions that are established under

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

tolerances in this final rule, do not

require the issuance of a proposed rule,

the requirements of the Regulatory

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

seq.) do not apply. Nevertheless, the

Agency has previously assessed whether

establishing tolerances, exemptions

from tolerances, raising tolerance levels

or expanding exemptions might

adversely impact small entities and

concluded, as a generic matter, that

there is no adverse economic impact.

The factual basis for the Agency’s

generic certification for tolerance

acations published on May 4, 1981 (46

FR 24950), and was provided to the

Chief Counsel for Advocacy of the Small

Business Administration.

X. Submission to Congress and the

Comptroller General

The Congressional Review Act, 5

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

Business Regulatory Enforcement

Fairness Act of 1996, generally provides

that before a rule may take effect, the

agency promulgating the rule must

submit a rule report, which includes a

copy of the rule, to each House of the

Congress and to the Comptroller General

of the United States. EPA will submit a

report containing this rule and other

required information to the U.S. Senate,

the U.S. House of Representatives, and

the Comptroller General of the United

States prior to publication of the rule in

the Federal Register. This rule is not a

‘‘major rule’’ as defined by 5 U.S.C.

804(2).

List of Subjects in 40 CFR Part 180

Environmental protection,

Administrative practice and procedure,

Agricultural commodities, Pesticides

and pests, Reporting and recordkeeping

requirements.

Dated: July 16, 1998.

James Jones,

Director, Registration Division, Office of

Pesticide Programs.

Therefore, 40 CFR chapter I is

amended as follows:

PART 180–[AMENDED]

1. The authority citation for part 180

continues to read as follows:

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

2. Section 180.535 is added to read as

follows:

§ 180.535 Fluroxypyr 1-methylheptyl ester;

tolerances for residues.

(a) General. [Reserved]

(b) Section 18 emergency exemptions.

Time-limited tolerances are established

for the combined residues of fluroxypyr

1-methylheptyl ester and its metabolite

fluroxypyr, in connection with use of

the pesticide under section 18

emergency exemptions granted by EPA.

The tolerances will expire and are

revoked on the dates specified in the

following table.

Commodity

Parts

per

million

Expiration/

RevocationDate

Aspirated grain

fractions ............. 0.6 12/1/99

Barley, grain .......... 0.5 12/1/99

Barley, hay ............ 20.0 12/1/99

Barley, straw .......... 12.0 12/1/99

Cattle, fat ............... 0.1 12/1/99

Cattle, kidney ......... 0.5 12/1/99

Cattle, mbyp .......... 0.1 12/1/99

Cattle meat ............ 0.1 12/1/99

Corn, field, forage .. 2.0 12/1/99

Corn, field, grain .... 0.05 12/1/99

Corn, field, stover .. 2.5 12/1/99

Corn, sweet, forage 2.0 12/1/99

Corn, sweet, K +

CWHR ................ 0.05 12/1/99

Corn, sweet, stover 2.5 12/1/99

Goats, fat ............... 0.1 12/1/99

Goats, kidney ........ 0.5 12/1/99

Goats, mbyp .......... 0.1 12/1/99

Goats, meat ........... 0.1 12/1/99

Hogs, fat ................ 0.1 12/1/99

Hogs, kidney .......... 0.5 12/1/99

Hogs, mbyp ........... 0.1 12/1/99

Hogs, meat ............ 0.1 12/1/99

Horses, fat ............. 0.1 12/1/99

Horses, kidney ....... 0.5 12/1/99

Horses, mbyp ........ 0.1 12/1/99

Horses, meat ......... 0.1 12/1/99

Milk ........................ 0.1 12/1/99

Sheep, fat .............. 0.1 12/1/99

Sheep, kidney ........ 0.5 12/1/99

Sheep, mbyp ......... 0.1 12/1/99

Sheep meat ........... 0.1 12/1/99

Wheat, forage ........ 12.0 12/1/99

Wheat, grain .......... 0.5 12/1/99

Wheat, hay ............ 20.0 12/1/99
Federal Register / Vol. 63, No. 150 /Wednesday, August 5, 1998 /Rules and Regulations 41735

Commodity

Parts

per

million

Expiration/

RevocationDate

Wheat, straw ......... 12.0 12/1/99

(c) Tolerances with regional

registrations. [Reserved]

(d) Indirect or inadvertent residues.

[Reserved]

[FR Doc. 98–20905 Filed 8–4–98; 8:45 am]

BILLING CODE 6560–50–F

FEDERAL COMMUNICATIONS

COMMISSION

47 CFR Part 73

[MM Docket No. 96–231; RM–8903]

Radio Broadcasting Services;

Redwood, MS

AGENCY: Federal Communications

Commission.

ACTION: Final rule.

SUMMARY: This document allots Channel

288A to Redwood, Mississippi, as that

community’s first local aural

transmission service, in response to a

petition filed by Dominant

Communications Corporation. See 61

FR 63809, December 2, 1996.

Coordinates used for Channel 288A at

Redwood are 32–27–13 NL and 90–48–

42 WL. With this action, the proceeding

is terminated.

DATES: Effective September 14, 1998. A

filing window for Channel 288A at

Redwood, Mississippi, will not be

opened at this time. Instead, the issue of

opening a filing window for this

channel will be addressed by the

Commission in a subsequent Order.

FOR FURTHER INFORMATION CONTACT:

Nancy Joyner, Mass Media Bureau, (202)

418–2180. Questions related to the

application filing process for Channel

288A at Redwood, Mississippi, should

be addressed to the Audio Services

Division, (202) 418–2700.

SUPPLEMENTARY INFORMATION: This is a

synopsis of the Commission’s Report

and Order, MM Docket No. 96–231,

adopted July 22, 1998, and released July

31, 1998. The full text of this

Commission decision is available for

inspection and copying during normal

business hours in the FCC’s Reference

Center (Room 239), 1919 M Street, NW.,

Washington, DC. The complete text of

this decision may also be purchased

from the Commission’s copy contractor,

International Transcription Service,

Inc., 1231 20th Street, NW.,

Washington, DC 20036, (202) 857–3800.

List of Subjects in 47 CFR Part 73

Radio broadcasting.

Part 73 of Title 47 of the Code of

Federal Regulations is amended as

follows:

PART 73—[AMENDED]

1. The authority citation for part 73

reads as follows:

Authority: 47 U.S.C. 154, 303, 334, 336.

§ 73.202 [Amended]

2. Section 73.202(b), the Table of FM

Allotments under Mississippi, is

amended by adding Redwood, Channel

288A.

Federal Communications Commission.

John A. Karousos,

Chief, Allocations Branch, Policy and Rules

Division, Mass Media Bureau.

[FR Doc. 98–20817 Filed 8–4–98; 8:45 am]

BILLING CODE 6712–01–P

FEDERAL COMMUNICATIONS

COMMISSION

47 CFR Part 73

[MM Docket No. 97–229; RM–9100, RM–

9231]

Radio Broadcasting Services;

Warrenton and Enfield, NC, La Crosse

and Powhatan, VA

AGENCY: Federal Communications

Commission.

ACTION: Final rule.

SUMMARY: The Commission, at the

request of MainQuad, Inc., substitutes

Channel 297A for Channel 297C2 at

Warrenton, NC, reallots Channel 297A

to Powhatan, VA, as the community’s

first local aural service, and modifies

the construction permit of Station

WXNC to specify Powhatan as its

community of license, and also allots

Channel 297A to Enfield, NC, as the

community’s first local aural service.

See 62 FR 61721, November 21, 1997.

Channel 297A can be allotted to

Powhatan in compliance with the

Commission’s minimum distance

separation requirements with a site

restriction of 10 kilometers (6.2 miles)

southeast, at coordinates 37–28–02

North Latitude and 77–51–10 West

Longitude, to avoid short-spacings to

Stations WRQX, Channel 297B,

Washington, DC and WUMX, Channel

298A, Charlotte, VA. Channel 297A can

be allotted to Enfield with a site

restriction of 1.7 kilometers (1 mile)

northwest, at coordinates 36–11–09; 77–

41–40, to avoid a short-spacing to

Station WNCT–FM, Channel 300C,

Greenville, NC. Mainquad, Inc.’s

proposal to reallot Channel 297C2 from

Warrenton to LaCrosse, VA, is

dismissed. With this action, this

proceeding is terminated.

DATES: Effective September 14, 1998. A

filing window for Channel 297A at

Enfield, NC, will not be opened at this

time. Instead, the issue of opening a

filing window for this channel will be

addressed by the Commission in a

subsequent order.

FOR FURTHER INFORMATION CONTACT:

Leslie K. Shapiro, Mass Media Bureau,

(202) 418–2180.

SUPPLEMENTARY INFORMATION: This is a

synopsis of the Commission’s Report

and Order, MM Docket No. 97–229,

adopted July 22, 1998, and released July

31, 1998. The full text of this

Commission decision is available for

inspection and copying during normal

business hours in the FCC Reference

Center (Room 239), 1919 M Street, NW.,

Washington, DC. The complete text of

this decision may also be purchased

from the Commission’s copy contractor,

International Transcription Services,

Inc., (202) 857–3800, 1231 20th Street,

NW, Washington, DC 20036.

List of Subjects in 47 CFR Part 73

Radio broadcasting.

Part 73 of Title 47 of the Code of

Federal Regulations is amended as

follows:

PART 73—[AMENDED]

1. The authority citation for part 73

continues to read as follows:

Authority: 47 U.S.C. 154, 303, 334, 336.

§ 73.202 [Amended]

2. Section 73.202(b), the Table of FM

Allotments under North Carolina, is

amended by removing Warrenton,

Channel 297C2, and adding Enfield,

Channel 297A.

3. Section 73.202(b), the Table of FM

Allotments under Virginia, is amended

by adding Powhatan, Channel 297A.

Federal Communications Commission.

John A. Karousos,

Chief, Allocations Branch, Policy and Rules

Division, Mass Media Bureau.

[FR Doc. 98–20816 Filed 8–4–98; 8:45 am]

BILLING CODE 6712–01–P