58364 Federal Register / Vol. 65, No. 190 / Friday, September 29, 2000 / Rules and Regulations

early in the process of developing the

proposed regulation.

This rule will not have substantial

direct effects on the states, on the

relationship between the national

government and the states, or on the

distribution of power and

responsibilities among the various

levels of government, as specified in

Executive Order 13132, because it

merely approves a state rule

implementing a federal standard, and

does not alter the relationship or the

distribution of power and

responsibilities established in the Clean

Air Act. Thus, the requirements of

section 6 of the Executive Order do not

apply to this rule.

E. Regulatory Flexibility Act

The Regulatory Flexibility Act (RFA)

generally requires an agency to conduct

a regulatory flexibility analysis of any

rule subject to notice and comment

rulemaking requirements unless the

agency certifies that the rule will not

have a significant economic impact on

a substantial number of small entities.

Small entities include small businesses,

small not-for-profit enterprises, and

small governmental jurisdictions. This

final rule will not have a significant

impact on a substantial number of small

entities because SIP approvals under

section 110 and subchapter I, part D of

the CAA do not create any new

requirements but simply approve

requirements that the State is already

imposing. Therefore, because the

Federal SIP approval does not create

any new requirements, EPA certifies

that this action will not have a

significant economic impact on a

substantial number of small entities.

Moreover, due to the nature of the

Federal-State relationship under the

CAA, preparation of flexibility analysis

would constitute Federal inquiry into

the economic reasonableness of state

action. The CAA forbids EPA to base its

actions concerning SIPs on such

grounds. Union Electric Co. v. U.S. EPA,

427 U.S. 246, 255–66 (1976); 42 U.S.C.

7410(a)(2).

F. Unfunded Mandates

Under section 202 of the Unfunded

Mandates Reform Act of 1995

(‘‘Unfunded Mandates Act’’), signed

into law on March 22, 1995, EPA must

prepare a budgetary impact statement to

accompany any proposed or final rule

that includes a federal mandate that

may result in estimated annual costs to

state, local, or tribal governments in the

aggregate; or to private sector, of $100

million or more. Under section 205,

EPA must select the most cost-effective

and least burdensome alternative that

achieves the objectives of the rule and

is consistent with statutory

requirements. Section 203 requires EPA

to establish a plan for informing and

advising any small governments that

may be significantly or uniquely

impacted by the rule.

EPA has determined that the final

approval action does not include a

federal mandate that may result in

estimated annual costs of $100 million

or more to either state, local, or tribal

governments in the aggregate, or to the

private sector. This federal action

approves pre-existing requirements

under state or local law, and imposes no

new requirements. Accordingly, no

additional costs to state, local, or tribal

governments, or to the private sector,

result from this action.

G. 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).

H. Petitions for Judicial Review

Under section 307(b)(1) of the CAA,

petitions for judicial review of this

action must be filed in the United States

Court of Appeals for the appropriate

circuit by November 28, 2000. Filing a

petition for reconsideration by the

Administrator of this final rule does not

affect the finality of this rule for the

purposes of judicial review nor does it

extend the time within which a petition

for judicial review may be filed, and

shall not postpone the effectiveness of

such rule or action. This action may not

be challenged later in proceedings to

enforce its requirements. (See section

307(b)(2).)

List of Subjects in 40 CFR Part 52

Environmental protection, Air

pollution control, Incorporation by

reference, Intergovernmental relations,

Nitrogen oxides, Ozone, Reporting and

recordkeeping requirements, Volatile

organic compounds.

Dated: August 21, 2000.

William J. Muszynski,

Acting Regional Administrator, Region 2.

40 CFR Part 52 is amended as follows:

PART 52—[AMENDED]

1. The authority citation for part 52

continues to read as follows:

Authority: 42 U.S.C. 7401 et seq.

Subpart HH—New York

2. Section 52.1683 is amended by

adding new paragraph (g) to read as

follows:

§ 52.1683 Control strategy: Ozone.

* * * * *

(g) EPA approves as a revision to the

New York State Implementation Plan,

the Stage II gasoline vapor recovery

comparability plan for upstate portions

of New York State submitted by the

New York State Department of

Environmental Conservation on April

18, 2000.

[FR Doc. 00–24789 Filed 9–28–00; 8:45 am]

BILLING CODE 6560–50–P

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Part 180

[OPP–301052; FRL–6745–9]

RIN 2070–AB78

Flucarbazone-sodium; Time-Limited

Pesticide Tolerances

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Final rule.

SUMMARY: This regulation establishes

time-limited tolerances for combined

residues of flucarbazone-sodium, 4,5-

dihydro-3-methoxy-4-methyl-5-oxo-N-

[[2(trifluoromethoxy)phenyl] sulfonyl]-

1H-1,2,4-triazole 1-carboxamide,

sodium salt) and its N-desmethyl

metabolite in or on wheat, forage at 0.30

parts per million (ppm); wheat, grain at

0.01 ppm; wheat, hay at 0.10 ppm; and

wheat, straw at 0.05 ppm; and combined

residues of flucarbazone-sodium and its

metabolites converted to 2-

(trifluoromethoxy)benzene sulfonamide

and calculated as flucarbazone-sodium

in or on milk at 0.005 ppm; meat and

meat byproducts (excluding liver) of

cattle, goats, hogs, horses and sheep at

0.01 ppm; and liver of cattle, goats,

hogs, horses and sheep at 1.5 ppm.

Bayer Corporation requested these

tolerances under the Federal Food,

Drug, and Cosmetic Act, as amended by

the Food Quality Protection Act of 1996.

Federal Register / Vol. 65, No. 190 / Friday, September 29, 2000 / Rules and Regulations 58365

The tolerances will expire and be

revoked on November 1, 2005.

DATES: This regulation is effective

September 29, 2000.Objections and

requests for hearings, identified by

docket control number OPP–301052,

must be received by EPA on or before

November 28, 2000.

ADDRESSES: Written objections and

hearing requests may be submitted by

mail, in person, or by courier. Please

follow the detailed instructions for each

method as provided in Unit VI. of the

SUPPLEMENTARY INFORMATION. To ensure

proper receipt by EPA, your objections

and hearing requests must identify

docket control number OPP–301052 in

the subject line on the first page of your

response.

FOR FURTHER INFORMATION CONTACT: By

mail: Joanne I. Miller, Registration

Division (7505C), Office of Pesticide

Programs, Environmental Protection

Agency, 1200 Pennsylvania Ave., NW.,

Washington, DC 20460; telephone

number: (703)–305–6224; and e-mail

address: miller.joanne@epa.gov.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

You may be affected by this action if

you are an agricultural producer, food

manufacturer, or pesticide

manufacturer. Potentially affected

categories and entities may include, but

are not limited to:

Categories NAICS Examples of Potentially Affected Entities

Industry 111 Crop production

112 Animal production

311 Food manufacturing

32532 Pesticide manufacturing

This listing is not intended to be

exhaustive, but rather provides a guide

for readers regarding entities likely to be

affected by this action. Other types of

entities not listed in the table could also

be affected. The North American

Industrial Classification System

(NAICS) codes have been provided to

assist you and others in determining

whether or not this action might apply

to certain entities. If you have questions

regarding the applicability of this action

to a particular entity, consult the person

listed under FOR FURTHER INFORMATION

CONTACT.

B. How Can I Get Additional

Information, Including Copies of this

Document and Other Related

Documents?

1. Electronically.You may obtain

electronic copies of this document, and

certain other related documents that

might be available electronically, from

the EPA Internet Home Page at http://

www.epa.gov/. To access this

document, on the Home Page select

‘‘Laws and Regulations,’’ ‘‘Regulations

and Proposed Rules,’’ and then look up

the entry for this document under the

‘‘Federal Register—Environmental

Documents.’’ You can also go directly to

the Federal Register listings at http://

www.epa.gov/fedrgstr/. To access the

OPPTS Harmonized Guidelines

referenced in this document, go directly

to the guidelines at http://www.epa.gov/

opptsfrs/home/guidelin.htm.

2. In person. The Agency has

established an official record for this

action under docket control number

OPP–301052. The official record

consists of the documents specifically

referenced in this action, and other

information related to this action,

including any information claimed as

Confidential Business Information (CBI).

This official record includes the

documents that are physically located in

the docket, as well as the documents

that are referenced in those documents.

The public version of the official record

does not include any information

claimed as CBI. The public version of

the official record, which includes

printed, paper versions of any electronic

comments submitted during an

applicable comment period is available

for inspection in the Public Information

and Records Integrity Branch (PIRIB),

Rm. 119, Crystal Mall #2, 1921 Jefferson

Davis Hwy., Arlington, VA, from 8:30

a.m. to 4 p.m., Monday through Friday,

excluding legal holidays. The PIRIB

telephone number is (703) 305–5805.

II. Background and Statutory Findings

In the Federal Register of October 8,

1999 (64 FR 195) (FRL–6384–2), EPA

issued a notice pursuant to section 408

of the Federal Food, Drug, and Cosmetic

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

amended by the Food Quality Protection

Act of 1996 (FQPA) (Public Law 104–

170) announcing the filing of a pesticide

petition (PP) for tolerance by Bayer

Corporation, 8400 Hawthorne Road,

Kansas City, Missouri 64120–0013. This

notice included a summary of the

petition prepared by Bayer 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

tolerances for combined residues of the

herbicide flucarbazone-sodium, 4,5-

dihydro-3-methoxy-4-methyl-5-oxo-N-

[[2(trifluoromethoxy)phenyl]sulfonyl]-

1H-1,2,4-triazole 1-carboxamide,

sodium salt) and its N-desmethyl

metabolite in or on wheat, forage at 0.30

ppm; wheat, grain at 0.01 ppm; wheat,

hay at 0.10 ppm; wheat, straw at 0.05

ppm, milk at 0.005 ppm; meat of cattle,

goats, hogs, horses and sheep at 0.01

ppm; and liver of cattle, goats, hogs,

horses and sheep at 0.60 ppm. As a

result of its review of scientific data

submitted in support of this petition,

the Agency has determined that

additional sulfonamide metabolites

should be included in the tolerance

expression for both wheat and the

associated animal commodities. The

submitted analytical method and

residue data for livestock are sufficient

to establish tolerances for livestock

commodities that include the additional

sulfonamide metabolites. The animal

tolerances requested by Bayer

Corporation for flucarbazone-sodium

and its N-desmethyl metabolite are

adequate to cover the additional

metabolites, with the exception of the

tolerance for liver, which EPA has

determined must be raised from 0.60

ppm to 1.5 ppm. However, before EPA

can establish tolerances for wheat

forage, grain, hay and straw that include

the sulfonamide metabolites, the

registrant must submit a revised method

and additional residue data that

measure not only the parent and Ndesmethyl metabolite, but also the

sulfonamide metabolites of concern.

Therefore, EPA is establishing timelimited tolerances for combined

residues of flucarbazone-sodium, 4,5-

dihydro-3-methoxy-4-methyl-5-oxo-N-

[[2(trifluoromethoxy)phenyl] sulfonyl]-

1H-1,2,4-triazole 1-carboxamide,

sodium salt) and its N-desmethyl

metabolite in or on wheat, forage at 0.30

ppm; wheat, grain at 0.01 ppm; wheat,

hay at 0.10 ppm; and wheat, straw at

0.05 ppm; and combined residues of

flucarbazone-sodium and its metabolites

converted to 2-

(trifluoromethoxy)benzene sulfonamide

and calculated as flucarbazone-sodium

in or on milk at 0.005 ppm; meat and

meat byproducts (excluding liver) of

cattle, goats, hogs, horses and sheep at

0.01 ppm; and liver of cattle, goats,

hogs, horses and sheep at 1.5 ppm. The

tolerances are being established as timelimited to allow time to develop

additional analytical methodology and

residue data for wheat to support

revised tolerances that include the

58366 Federal Register / Vol. 65, No. 190 / Friday, September 29, 2000 / Rules and Regulations

sulfonamide metabolites. These

tolerances will expire and be revoked on

November 1, 2005. Although EPA does

not have sufficient data to establish

wheat tolerances that include the

sulfonamide metabolites, sufficient data

are available for the Agency to estimate

human exposure and risk from these

metabolites as described in the

‘‘Exposure Assessment’’ section below.

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 aggrege

exposure to pesticide residues. For

further discussion of the regulatory

requirements of section 408 and a

complete description of the risk

assessment process, see the final rule on

Bifenthrin Pesticide Tolerances (62 FR

62961, November 26, 1997) (FRL–5754–

7).

III. 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 and to make a determination

on aggregate exposure, consistent with

section 408(b)(2), for tolerances for

combined residues of flucarbazonesodium, 4,5-dihydro-3-methoxy-4-

methyl-5-oxo-N-

[[2(trifluoromethoxy)phenyl] sulfonyl]-

1H-1,2,4-triazole 1-carboxamide,

sodium salt) and its N-desmethyl

metabolite in or on wheat, forage at 0.30

ppm; wheat, grain at 0.01 ppm; wheat,

hay at 0.10 ppm; and wheat, straw at

0.05 ppm; and combined residues of

flucarbazone-sodium and its metabolites

converted to 2-

(trifluoromethoxy)benzene sulfonamide

and calculated as flucarbazone-sodium

in or on milk at 0.005 ppm; meat and

meat byproducts (excluding liver) of

cattle, goats, hogs, horses and sheep at

0.01 ppm; and liver of cattle, goats,

hogs, horses and sheep at 1.5 ppm.

EPA’s assessment of exposures and risks

associated with establishing these

tolerances follows.

A. Toxicological Profile

EPA has evaluated the available

toxicity data and considered its validity,

completeness, and reliability as well as

the relationship of the results of the

studies to human risk. EPA has also

considered available information

concerning the variability of the

sensitivities of major identifiable

subgroups of consumers, including

infants and children. The nature of the

toxic effects caused by flucarbazonesodium are discussed in the following

Table 1 as well as the no observed

adverse effect level (NOAEL) and the

lowest observed adverse effect level

(LOAEL) from the toxicity studies

reviewed.

TABLE 1.—SUBCHRONIC, CHRONIC AND OTHER TOXICITY

Guideline No. Study Type Results

870.3100 28–Day oral toxicity in rodents (rats) NOAEL = 27 mg/kg/day in males and 25 mg/kg/day in females.

LOAEL = 266 mg/kg/day in males and 251 mg/kg/day in females based

on immunological changes in both sexes

870.3100 90–Day oral toxicity in rodents (rats) NOAEL = 73.5 mg/kg/day in males and 102 mg/kg/day in females

LOAEL = 287 mg/kg/day in males and 358 mg/kg/day in females based

on immunological findings in both sexes

870.3100 28–Day oral toxicity in rodents (mice) NOAEL = > 4,554 mg/kg/day in males and 6,429 mg/kg/day in females

LOAEL > 4,554 mg/kg/day in males and 6,429 mg/kg/day in females.

There were no signs of toxicity attributable to treatment at any dose

level

870.3100 90–Day oral toxicity in rodents (mice) NOAEL = > 2,083 mg/kg/day in males and 3,051 mg/kg/day in females

LOAEL > 2,083 mg/kg/day in males and 3,051 mg/kg/day in females.

There were no signs of toxicity attributable to treatment at any dose

level.

870.3150 28–Day oral toxicity in nonrodents

(dogs)

NOAEL = 164 mg/kg/day in males and 171 mg/kg/day in females

LOAEL = 1,614 mg/kg/day in males and 1,319 mg/kg/day in females

based on decreased body weight gain, decreased food consumption,

decreased T4 levels and increased thyroxine-binding capacity, induction

of microsomal enzymes, increased liver weight and liver histopathology

in both sexes

870.3150 90–Day oral toxicity in nonrodents

(dogs)

NOAEL = 33.8 mg/kg/day in males and 35.2 mg/kg/day in females with

the occurrence of slight, adaptive induction of hepatic microsomal enzymes

LOAEL = 162 mg/kg/day in males and 170 mg/kg/day in females based

on decreased T4 levels, increased thyroxine-binding capacity, induction

of microsomal enzymes, gross pathology and histopathology in the

stomach, and histopathology in the liver in both sexes

870.3200 21/28–Day dermal toxicity in rabbits NOAEL ≥1,000 mg/kg/day for both sexes.

Federal Register / Vol. 65, No. 190 / Friday, September 29, 2000 / Rules and Regulations 58367

TABLE 1.—SUBCHRONIC, CHRONIC AND OTHER TOXICITY—Continued

Guideline No. Study Type Results

LOAEL > 1,000 mg/kg/day. There were no signs of toxicity attributable to

treatment at any dose level.

870.3250 90–Day dermal toxicity in rats Not applicable (NA)

870.3465 90–Day inhalation toxicity in rats NA

870.3700a Prenatal developmental toxicity in

rats

Maternal NOAEL = > 1,000 mg/kg/day

LOAEL > 1,000 mg/kg/day

Developmental NOAEL = > 1,000 mg/kg/day

LOAEL > 1,000 mg/kg/day

870.3700b Prenatal developmental toxicity in

rabbits

Maternal NOAEL = 100 mg/kg/day

LOAEL = 300 mg/kg/day based on decreased food consumption and increased clinical signs

Developmental NOAEL = 300 mg/kg/day

LOAEL = 500 mg/kg/day based on decreased fetal weight and increased

incidence of delayed fetal ossification

870.3800 Reproduction and fertility effects in

rats

Parental/Systemic NOAEL = 287 mg/kg/day for males and 340 mg/kg/day

for females with a slight, increased incidence of moderate cecal enlargement occurring as an adaptive response to treatment

LOAEL = 800 mg/kg/day for males based on decreased liver weight and

991 mg/kg/day for females based on decreased uterine weight and increased incidence of severe cecal enlargement

Reproductive/Offspring NOAEL = 287 mg/kg/day for males and 340 mg/

kg/day for females

LOAEL = 800 mg/kg/day for males and 991 mg/kg/day for females based

on reduced pup weights, decreased liver weight in male pups, marbled

liver, air filled stomach

870.4100b Chronic toxicity in dogs NOAEL = 35.9 mg/kg/day in males and 37.1 mg/kg/day in females.

LOAEL = 183 mg/kg/day in males and 187 mg/kg/day in females based

upon body weight gain depression and increased N-demethylase levels

in both sexes, decreased T4 levels and marginally increased liver

weight in females.

870.4300 2–Year Chronic toxicity/carcinogenicity in ratsNOAEL = 125 mg/kg/day in males and females

LOAEL = 1,000 mg/kg/day in males and females based on decreased

body weight and increased food consumption in females, thickened mucosa of the glandular stomach in both sexes, inflammatory infiltrates

(males), vacuolation of the squamous epithelium in the fore-stomach

(females) and immunological effects in males

No evidence of carcinogenicity

870.4200b 2–Year Carcinogenicity in mice NOAEL = 275 mg/kg/day in males and 459 mg/kg/day in females

LOAEL = 2,066 mg/kg/day in males and 3,212 mg/kg/day in females

based on decreased body weight in both sexes and increased food consumption in males.

No evidence of carcinogenicity

870.5100 Gene Mutation; reverse gene mutation assay in bacteriaThere was no evidence of induced mutant colonies over background.

870.5100 Gene Mutation; reverse gene mutation assay in bacteria with MKH

10868, an animal, plant, and soil

metabolite

There was no evidence of induced mutant colonies over background

870.5300 Gene mutation assay in V79 cultured

mammalian cells

No increase in mutant frequency above that of negative controls up to the

limit dose.

870.5375 Cytogenetics; in vitro mammalian cytogenetics assayNo increases in aberrant metaphases were observed up to the limit dose.

870.5395 bone marrow micronucleus assay There was no significant increase in the frequency of micronucleated polychromatic erythrocytes in bone marrow at 2,000 mg/kg.

58368 Federal Register / Vol. 65, No. 190 / Friday, September 29, 2000 / Rules and Regulations

TABLE 1.—SUBCHRONIC, CHRONIC AND OTHER TOXICITY—Continued

Guideline No. Study Type Results

870.5550 Other Genotoxicity; Unscheduled

DNA synthesis in primary rat

hepatocytes

There was no evidence of unscheduled DNA synthesis up to cytotoxic levels.

870.6200a Acute neurotoxicity screening battery

in rats

NOAEL = 500 mg/kg/day for males and females

LOAEL = 2,000 mg/kg/day based on increased incidence of perianal staining in males, decreased motor activity and locomotor activity in both

sexes and increase in the incidence of animals exhibiting low levels of

activity in open field in both sexes.

870.6200b Subchronic neurotoxicity screening

battery in rats

NOAEL = 147 mg/kg/day in males and 1,736 mg/kg/day in females

LOAEL = 1,482 mg/kg/day based on decreased body weight, decreased

body weight gain, and decreased food consumption in males. LOAEL >

1,736 mg/kg/day in females.

870.6300 Developmental neurotoxicity in rats NA

870.7800 Antibody Plaque-forming cell assay

in male rats

NOAEL = > 1,000 mg/kg/day

LOAEL > 1,000 mg/kg/day

870.7800 Antibody Plaque-forming cell assay

in female rats

NOAEL = > 1,000 mg/kg/day

LOAEL > 1,000 mg/kg/day

870.7800 Splenic T-cells, B-cells, and NK-cell

assay in male rats

NOAEL = > 1,000 mg/kg/day

LOAEL > 1,000 mg/kg/day

870.7800 Splenic T-cells, B-cells, and NK-cell

assay in female rats

NOAEL = > 1,000 mg/kg/day

LOAEL > 1,000 mg/kg/day

870.7800 Plaque-Forming cell assay in rats NOAEL = 2,205 mg/kg/day in males and 2,556 mg/kg/day in females

LOAEL > 2,205 mg/kg/day in males and 2,556 mg/kg/day in females

870.7485 Metabolism in rats There were no sex-related differences in the absorption, distribution, metabolism or excretion. Based on urinary excretion, absorption was 15–

30% and maximum plasma concentrations were achieved within 30

minutes. At sacrifice, tissues and carcass contained less than 1% of radioactivity. The highest residue in the tissues was in the liver. Greater

than 90% of the administered dose was eliminated within 24 hours. The

major component in urine and feces was unchanged parent which represented 90–95% of the administered dose.

870.7485 Metabolism in rats Major component in urine and feces was unchanged parent which represented 94% of the administered dose. Less than 1% of the administered dose was recovered in the carcass, tissues, expired air, or cage

wash. Highest residue was in the liver.

870.7485 Metabolism in rats: M: 5.13 mg/kg of

phenyl- UL-C14 MKH 6562 sulfonamide lactate (plant metabolite

of MKH 6562)

Metabolized via two pathways. One pathway involved the oxidative

decarboxylation of sulfonamide lactate to form sulfonamide acetate. The

other pathway involved the hydrolysis of sulfonamide lactate and sulfonamide acetate to give sulfonamide.

870.7485 Metabolism in rats: M: 5 mg/kg of

phenyl-C14 MKH 6562 sulfonamide

alanine (a plant metabolite of MKH

6562)

Approximately 70% absorption and elimination with 98% recovery in urine

and feces. Several metabolites in addition to parent (17%). Less than

1% of the administered dose was recovered in the carcass, tissues, expired air, or cage wash. Highest residue was in the liver.

870.7600 Dermal penetration NA

B. Toxicological Endpoints

The dose at which no adverse effects

are observed (the NOAEL) from the

toxicology study identified as

appropriate for use in risk assessment is

used to estimate the toxicological level

of concern (LOC). However, the lowest

dose at which adverse effects of concern

are identified (the LOAEL) is sometimes

used for risk assessment if no NOAEL

was achieved in the toxicology study

selected. An uncertainty factor (UF) is

applied to reflect uncertainties inherent

in the extrapolation from laboratory

animal data to humans and in the

Federal Register / Vol. 65, No. 190 / Friday, September 29, 2000 / Rules and Regulations 58369

variations in sensitivity among members

of the human population as well as

other unknowns. An UF of 100 is

routinely used, 10X to account for

interspecies differences and 10X for

intra species differences.

For dietary risk assessment (other

than cancer) the Agency uses the UF to

calculate an acute or chronic reference

dose (acute RfD or chronic RfD) where

the RfD is equal to the NOAEL divided

by the appropriate UF (RfD = NOAEL/

UF). Where an additional safety factor is

retained due to concerns unique to the

FQPA, this additional factor is applied

to the RfD by dividing the RfD by such

additional factor. The acute or chronic

Population Adjusted Dose (aPAD or

cPAD) is a modification of the RfD to

accommodate this type of FQPA Safety

Factor.

For non-dietary risk assessments

(other than cancer) the UF is used to

determine the LOC. For example, when

100 is the appropriate UF (10X to

account for interspecies differences and

10X for intraspecies differences) the

LOC is 100. To estimate risk, a ratio of

the NOAEL to exposures (margin of

exposure (MOE) = NOAEL/exposure) is

calculated and compared to the LOC.

The linear default risk methodology

(Q*) is the primary method currently

used by the Agency to quantify

carcinogenic risk. The Q* approach

assumes that any amount of exposure

will lead to some degree of cancer risk.

A Q* is calculated and used to estimate

risk which represents a probability of

occurrence of additional cancer cases

(e.g., risk is expressed as 1 x 10-6 or one

in a million). Under certain specific

circumstances, MOE calculations will

be used for the carcinogenic risk

assessment. In this non-linear approach,

a ‘‘point of departure’’ is identified

below which carcinogenic effects are

not expected. The point of departure is

typically a NOAEL based on an

endpoint related to cancer effects

though it may be a different value

derived from the dose response curve.

To estimate risk, a ratio of the point of

departure to exposure (MOEcancer = point

of departure/exposures) is calculated. A

summary of the toxicological endpoints

for flucarbazone-sodium used for

human risk assessment is shown in the

following Table 2:

TABLE 2.—SUMMARY OF TOXICOLOGICAL DOSE AND ENDPOINTS FOR FLUCARBAZONE-SODIUM] FOR USE IN HUMAN RISK

ASSESSMENT

Exposure Scenario Dose Used in Risk Assessment, UF

FQPA SF* and Level of

Concern for Risk AssessmentStudy and Toxicological Effects

Acute Dietary females 13–50

years of age

NOAEL = 300 mg/kg/

day; UF = 100; Acute

RfD = 3.0 mg/kg/day

FQPA SF = 1X; aPAD

= acute RfD ÷ FQPA

SF = 3.0 mg/kg/day

Developmental Toxicity Study - rabbit; Developmental

LOAEL = 500 mg/kg/day based on decreased fetal

body weight and delayed ossification.

Chronic Dietary all populations NOAEL = 35.9 mg/kg/

day; UF = 100;

Chronic RfD = 0.36

mg/kg/day;

FQPA SF = 1X; cPAD

= chronic RfD ÷

FQPA SF = 0.36 mg/

kg/day

One year dog feeding study LOAEL = 183 mg/kg/day

based on decreased body weight gain, decreased

thyroxine, increased N-demethylase, and increased

liver weight

* The reference to the FQPA Safety Factor refers to any additional safety factor retained due to concerns unique to the FQPA.

C. Exposure Assessment

1. Dietary exposure from food and

feed uses. No tolerances have previously

been established for flucarbazonesodium. Risk assessments were

conducted by EPA to assess dietary

exposures from flucarbazone-sodium in

food as follows:

i. Acute exposure. Acute dietary risk

assessments are performed for a fooduse 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. An appropriate

endpoint attributable to a single

exposure was not identified for the

general population, including infants

and children. The decreased motor and

locomotor activity observed at 2,000

mg/kg on the day of dosing only in the

acute neurotoxicity study in rats was

reversible within 18 minutes. The

NOAEL of 500 mg/kg for these findings

was not considered appropriate for

selection as an acute dietary endpoint

for the general population. An acute

dietary risk assessment was performed

for flucarbazone-sodium for the

population subgroup, females 13 to 50

years old, based on the results of the

rabbit developmental toxicity study.

The Dietary Exposure Evaluation Model

(DEEM) analysis evaluated the

individual food consumption as

reported by respondents in the USDA

[1989–1992] nationwide Continuing

Surveys of Food Intake by Individuals

(CSFII) and accumulated exposure to

the chemical for each commodity. The

following assumptions were made for

the acute exposure assessment: For all

commodities, 100% crop treated was

assumed. In order to account for the

metabolites of concern in wheat and

livestock commodities, the anticipated

residue levels (parent and metabolites of

concern) to be used in the dietary

exposure assessment were determined.

Using the ratio of the sulfonamide

metabolites to the sum of the parent and

N-desmethyl metabolite observed in the

wheat metabolism study and the

Highest Average Field Trial (HAFT)

value from the crop field trial studies,

the anticipated total residues (parent

and metabolites of concern) expected to

be in wheat were determined. A

processed wheat food/feed study was

not submitted in support of this

petition. Therefore, in order to represent

the worse case scenario, the wheat

maximum theoretical concentration

factor of 8x (Table 1, Residue Chemistry

Test Guidelines OPPTS 860.1520) was

used for all wheat commodities. Default

concentration factors were used for all

other commodities in DEEM.

ii. Chronic exposure. In conducting

this chronic dietary risk assessment the

Dietary Exposure Evaluation Model

(DEEM) analysis evaluated the

individual food consumption as

reported by respondents in the USDA

1989–1992 nationwide CSFII and

accumulated exposure to the chemical

for each commodity. The following

assumptions were made for the chronic

exposure assessments: For all

commodities, 100% crop treated was

assumed. In order to account for the

metabolites of concern in wheat and

livestock commodities, the anticipated

residue levels (parent and metabolites of

concern) to be used in the dietary

exposure assessment were determined.

Using the ratio of the sulfonamide

metabolites to the sum of the parent and

N-desmethyl metabolite observed in the

wheat metabolism study, and the

Highest Average Field Trial (HAFT)

58370 Federal Register / Vol. 65, No. 190 / Friday, September 29, 2000 / Rules and Regulations

value from the crop field trial study, the

anticipated total residues (parent and

metabolites of concern) expected to be

in wheat were determined. A processed

wheat food/feed study was not

submitted in support of this petition.

Therefore, in order to represent the

worse case scenario, the wheat

maximum theoretical concentration

factor of 8x (Table 1, Residue Chemistry

Test Guidelines OPPTS 860.1520) was

used for all wheat commodities. Default

concentration factors were used for all

other commodities in DEEM.

iii. Cancer. The Agency concluded

that flucarbazone-sodium was negative

for carcinogenic potential in mice and

rats and classified flucarbazone-sodium

as ‘‘not likely’’ to be a human

carcinogen according to EPA Draft

Guidelines for Carcinogen Risk

Assessment. Therefore, a cancer dietary

exposure analysis was not performed.

Section 408(b)(2)(E) authorizes EPA to

use available data and information on

the anticipated residue levels of

pesticide residues in food and the actual

levels of pesticide chemicals that have

been measured in food. If EPA relies on

such information, EPA must require that

data be provided 5 years after the

tolerance is established, modified, or

left in effect, demonstrating that the

levels in food are not above the levels

anticipated. Following the initial data

submission, EPA is authorized to

require similar data on a time frame it

deems appropriate. As required by

section 408(b)(2)(E), EPA will issue a

data call-in for information relating to

anticipated residues to be submitted no

later than 5 years from the date of

issuance of this tolerance. EPA used

anticipated residues in this case to

estimate exposure to the sulfonamide

metabolites of flucarbazone-sodium in

wheat that are not included in the timelimited tolerance expression. As a

condition of registration, EPA will

require Bayer Corporation to submit

revised analytical methodology and

wheat residue data that measure all

residues of concern, including the

sulfonamide metabolites. These data

must be submitted within 3 years of

registration, well within the 5 year time

frame specified in the regulations, and

should allow the Agency to set

tolerances for wheat that include these

metabolites and eliminate the need for

sulfonamide anticipated residue

calculations in future risk assessments

for flucarbazone-sodium.

2. Dietary exposure from drinking

water. The Agency lacks sufficient

monitoring exposure data to complete a

comprehensive dietary exposure

analysis and risk assessment for

flucarbazone-sodium in drinking water.

Because the Agency does not have

comprehensive monitoring data,

drinking water concentration estimates

are made by reliance on simulation or

modeling taking into account data on

the physical characteristics of

flucarbazone-sodium.

The Agency uses the Generic

Estimated Environmental Concentration

(GENEEC) or the Pesticide Root Zone/

Exposure Analysis Modeling System

(PRZM/EXAMS) to estimate pesticide

concentrations in surface water and the

Screening Concentration in Ground

Water model (SCI-GROW), which

predicts pesticide concentrations in

groundwater. In general, EPA will use

GENEEC (a tier 1 model) before using

PRZM/EXAMS (a tier 2 model) for a

screening-level assessment for surface

water. The GENEEC model is a subset of

the PRZM/EXAMS model that uses a

specific high-end runoff scenario for

pesticides. GENEEC incorporates a farm

pond scenario, while PRZM/EXAMS

incorporate an index reservoir

environment in place of the previous

pond scenario. The PRZM/EXAMS

model includes a percent crop area

factor as an adjustment to account for

the maximum percent crop coverage

within a watershed or drainage basin.

None of these models includes

consideration of the impact processing

(mixing, dilution, or treatment) of raw

water for distribution as drinking water

would likely have on the removal of

pesticides from the source water. The

primary use of these models by the

Agency at this stage is to provide a

coarse screen for sorting out pesticides

for which it is highly unlikely that

drinking water concentrations would

ever exceed human health levels of

concern.

Since the models used are considered

to be screening tools in the risk

assessment process, the Agency does

not use estimated environmental

concentrations (EECs) from these

models to quantify drinking water

exposure and risk as a %RfD or PAD.

Instead, drinking water levels of

comparison (DWLOCs) are calculated

and used as a point of comparison

against the model estimates of a

pesticide’s concentration in water.

DWLOCs are theoretical upper limits on

a pesticide’s concentration in drinking

water in light of total aggregate exposure

to a pesticide in food, and from

residential uses. Since DWLOCs address

total aggregate exposure to flucarbazonesodium they are further discussed in the

aggregate risk sections below.

Based on the GENEEC and SCI-GROW

models the EECs of flucarbazonesodium (parent only) in surface water

and ground water for acute exposures

are estimated to be 1.42 parts per billion

(ppb) for surface water and 0.2 ppb for

ground water. The EECs for chronic

exposures are estimated to be 1.25 ppb

for surface water and 0.2 ppb for ground

water.

Based on the GENEEC model, total

flucarbazone-sodium EECs (parent plus

metabolites) in surface water are not

likely to exceed 1.45 ppb for acute

exposures and 1.44 ppb for chronic (60-

day) exposures. Agency interim policy

recommends that the 60–day GENEEC

value to be divided by an adjustment

factor of 3 to obtain a value for chronic

risk assessment calculations. Therefore,

a surface water value of 0.48 ppb was

used for chronic risk assessment.

Because the degradates of

flucarbazone-sodium are so resistant to

aerobic metabolism in soil, they lie

outside the range of environmental

characteristics from which SCI-GROW

was developed. It was therefore not

appropriate in this case to use the model

to estimate total flucarbazone-sodium

EECs in ground water. Instead, the

concentration of total flucarbazone

residues in soil porewater of the top 1-

foot of soil immediately postapplication

was estimated to be approximately 50

ppb. This number would be an upper

limit on the amount of chemical that

could be found in the soil porewater

and was used by the Agency as an

estimate of expected residues of

flucarbazone-sodium and its metabolites

in ground water for risk assessment

purposes.

3. From non-dietary exposure. The

term ‘‘residential exposure’’ is used in

this document to refer to nonoccupational, non-dietary exposure

(e.g., for lawn and garden pest control,

indoor pest control, termiticides, and

flea and tick control on pets).

Flucarbazone-sodium is not registered

for use on any sites that would result in

residential exposure.

4. Cumulative exposure to substances

with a 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.’’

EPA does not have, at this time,

available data to determine whether

flucarbazone-sodium 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, flucarbazoneVerDate 11<MAY>2000 19:39 Sep 28, 2000 Jkt 190000 PO 00000 Frm 00028 Fmt 4700 Sfmt 4700 E:\FR\FM\29SER1.SGM pfrm01 PsN: 29SER1
Federal Register / Vol. 65, No. 190 / Friday, September 29, 2000 / Rules and Regulations 58371

sodium 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 flucarbazone-sodium has a

common mechanism of toxicity with

other substances. For information

regarding EPA’s efforts to determine

which chemicals have a common

mechanism of toxicity and to evaluate

the cumulative effects of such

chemicals, see the final rule for

Bifenthrin Pesticide Tolerances (62 FR

62961, November 26, 1997).

D. Safety Factor for Infants and

Children

1. Safety factor for infants and

children—i. In general. FFDCA section

408 provides that EPA shall apply an

additional tenfold margin of safety for

infants and children in the case of

threshold effects to account for prenatal

and postnatal toxicity and the

completeness of the data base on

toxicity and exposure 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 (MOE) analysis or through

using uncertainty (safety) factors in

calculating a dose level that poses no

appreciable risk to humans.

ii. Prenatal and postnatal sensitivity.

No increased quantitative or qualitative

susceptibility was seen following

prenatal and/or postnatal exposures.

There were no developmental findings

in rats up to the limit dose of 1,000 mg/

kg/day. In the rabbit developmental

toxicity study, the effects seen in fetuses

(decreased fetal body weight and

delayed ossification) are at dose levels

equal to or greater than doses where

maternal toxicity (increased clinical

signs and decreased food consumption)

were observed. In a 2-generation

reproductive toxicity study in rats, the

effects seen in offspring were at dose

levels equal to or greater than doses

where parental toxicity were seen.

iii. Conclusion. There is a complete

toxicity data base for flucarbazonesodium and exposure data are complete

or are estimated based on data that

reasonably accounts for potential

exposures. EPA determined that the 10X

safety factor to protect infants and

children should be removed. The FQPA

factor is removed because there is no

indication of quantitative or qualitative

increased susceptibility of rats or rabbits

to in utero and/or postnatal exposure; a

developmental neurotoxicity study is

not required; the dietary (food and

drinking water) exposure assessments

will not underestimate the potential

exposures for infants and children; and

there are no registered residential uses

at the current time.

E. Aggregate Risks and Determination of

Safety

To estimate total aggregate exposure

to a pesticide from food, drinking water,

and residential uses, the Agency

calculates DWLOCs which are used as a

point of comparison against the model

estimates of a pesticide’s concentration

in water (EECs). DWLOC values are not

regulatory standards for drinking water.

DWLOCs are theoretical upper limits on

a pesticide’s concentration in drinking

water in light of total aggregate exposure

to a pesticide in food and residential

uses. In calculating a DWLOC, the

Agency determines how much of the

acceptable exposure (i.e., the PAD) is

available for exposure through drinking

water (e.g., allowable chronic water

exposure (mg/kg/day) = cPAD - (average

food + residential exposure)). This

allowable exposure through drinking

water is used to calculate a DWLOC.

A DWLOC will vary depending on the

toxic endpoint, drinking water

consumption, and body weights. Default

body weights and consumption values

as used by the USEPA Office of Water

are used to calculate DWLOCs: 2L/70 kg

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

and 1L/10 kg (child). Default body

weights and drinking water

consumption values vary on an

individual basis. This variation will be

taken into account in more refined

screening-level and quantitative

drinking water exposure assessments.

Different populations will have different

DWLOCs. Generally, a DWLOC is

calculated for each type of risk

assessment used: acute, short-term,

intermediate-term, chronic, and cancer.

When EECs for surface water and

groundwater are less than the calculated

DWLOCs, OPP concludes with

reasonable certainty that exposures to

the pesticide 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. Because OPP considers the

aggregate risk resulting from multiple

exposure pathways associated with a

pesticide’s uses, levels of comparison in

drinking water may vary as those uses

change. If new uses are added in the

future, OPP will reassess the potential

impacts of residues of the pesticide in

drinking water as a part of the aggregate

risk assessment process.

1. Acute risk. Using the exposure

assumptions discussed in this unit for

acute exposure, the acute dietary

exposure from food to flucarbazonesodium will occupy < 1% of the aPAD

for females 13 to 50 years old. Since an

appropriate endpoint attributable to a

single exposure was not identified for

the general population, including

infants and children, an acute exposure

assessment was not performed for these

population subgroups. In addition, there

is potential for acute dietary exposure to

flucarbazone-sodium in drinking water.

After calculating DWLOCs and

comparing them to the EECs for surface

and ground water, EPA does not expect

the aggregate exposure to exceed 100%

of the aPAD for the population of

concern (females 13 to 50 years old), as

shown in the following Table 3:

TABLE 3.—AGGREGATE RISK ASSESSMENT FOR ACUTE EXPOSURE TO FLUCARBAZONE-SODIUM

Population Subgroup aPAD (mg/

kg)

%aPAD

(Food)

Surface

Water EEC

(ppb)

Ground

Water EEC

(ppb)

Acute

DWLOC

(ppb)

Females, 13 to 50 years old 3 <1 1.45 50 90,000

2. Chronic risk. Using the exposure

assumptions described in this unit for

chronic exposure, EPA has concluded

that exposure to flucarbazone-sodium

from food will utilize 1% of the cPAD

for the U.S. population, <1% of the

cPAD for all infants less than 1 year old

and 2% of the cPAD for children 1 to

6 years old, the population subgroup

with the highest estimated exposure to

flucarbazone-sodium. There are no

residential uses for flucarbazone-sodium

that result in chronic residential

exposure to flucarbazone-sodium. In

addition, there is potential for chronic

dietary exposure to flucarbazonesodium in drinking water. After

calculating the DWLOCs and comparing

58372 Federal Register / Vol. 65, No. 190 / Friday, September 29, 2000 / Rules and Regulations

them to the EECs for surface and ground

water, EPA does not expect the

aggregate exposure to exceed 100% of

the cPAD, as shown in the following

Table 4:

TABLE 4.—AGGREGATE RISK ASSESSMENT FOR CHRONIC (NON-CANCER) EXPOSURE TO FLUCARBAZONE-SODIUM

Population Subgroup cPAD mg/

kg/day

% cPAD

(Food)

Surface

Water EEC

(ppb)

Ground

Water EEC

(ppb)

Chronic

DWLOC

(ppb)

U.S. Population 0.36 1 0.48 50 12,000

Infants less than 1 year old 0.36 <1 0.48 50 3,600

Children 1 to 6 years old 0.36 2 0.48 50 3,500

3. Short-term risk. Short-term

aggregate exposure takes into account

residential exposure plus chronic

exposure to food and water (considered

to be a background exposure level).

Flucarbazone-sodium is not registered

for use on any sites that would result in

residential exposure. Therefore, the

aggregate risk is the sum of the risk from

food and water, which do not exceed

the Agency’s level of concern.

4. Intermediate-term risk.

Intermediate-term aggregate exposure

takes into account residential exposure

plus chronic exposure to food and water

(considered to be a background

exposure level).

Flucarbazone-sodium is not registered

for use on any sites that would result in

residential exposure. Therefore, the

aggregate risk is the sum of the risk from

food and water, which do not exceed

the Agency’s level of concern.

5. Aggregate cancer risk for U.S.

population. The Agency concluded that

flucarbazone-sodium was negative for

carcinogenic potential in mice and rats

and classified flucarbazone-sodium as

‘‘not likely’’ to be a human carcinogen

according to EPA Draft Guidelines for

Carcinogen Risk Assessment. Therefore,

a cancer dietary exposure analysis was

not performed.

6. Determination of safety. Based on

these risk assessments, EPA concludes

that there is a reasonable certainty that

no harm will result to the general

population, and to infants and children

from aggregate exposure to

flucarbazone-sodium residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

The petitioner has proposed residue

analytical methods for tolerance

enforcement in wheat and livestock

commodities. The analytical

enforcement method for wheat employs

accelerated solvent extraction, clean-up

using solid phase extraction columns

followed by detection and quantitation

by liquid chromatography/tandem mass

spectroscopy (LC/MS/MS). The

analytical method for livestock

commodities is a common moiety

method which measures residues of

flucarbazone-sodium (MKH6562) in

animal tissues and milk by extracting

and hydrolysing MKH 6562 and MKH

6562-related residues to MKH 6562

sulfonamide. Detection is achieved

using negative ion electrospray mass

spectrometry using deuterated MKH

6562 sulfonamide as an internal

standard. Both methods have undergone

successful validations by independent

laboratories. They are currently being

validated by the Analytical Chemistry

Branch laboratories, BEAD (7503C),

Office of Pesticide Programs. Upon

successful completion of the EPA

validation and the granting of this

registration these methods will be

forwarded to FDA for publication in a

future revision of the Pesticide

Analytical Manual, Vol-II (PAM-II).

Prior to publication in PAM-II and upon

request, the methods will be available

from the Analytical Chemistry Branch

(ACB), BEAD (7503C), Environmental

Science Center, 701 Mapes Road, Ft

George G. Meade, MD 20755–5350;

contact Francis D. Griffith, Jr, telephone

(410) 305–2905, e-mail

griffith.francis@epa.gov. The analytical

standards for these methods are also

available from the EPA National

Pesticide Standard Repository at the

same location.

B. International Residue Limits

A default Maximum Residue Limit

(MRL) of 0.01 ppm has been established

in Canada for residues of flucarbazonesodium and its N-desmethyl metabolite

on wheat grain. This value is consistent

with the tolerance being established in

the United States on wheat grain. There

are no Codex MRLs for this compound

on wheat. Therefore, no compatibility

issues exist with Codex in regard to the

U.S. tolerances discussed in this review.

C. Conditions

The registration of flucarbazonesodium will be time-limited and

conditioned upon submission of a

revised method and additional residue

data for wheat commodities that

measure all of the metabolites of

concern. In addition, the registrant must

submit a 28–day rat inhalation study

and additional storage stability data.

V. Conclusion

Therefore, time-limited tolerances are

established for combined residues of

flucarbazone-sodium, 4,5-dihydro-3-

methoxy-4-methyl-5-oxo-N-

[[2(trifluoromethoxy)phenyl] sulfonyl]-

1H-1,2,4-triazole 1-carboxamide,

sodium salt) and its N-desmethyl

metabolite in or on wheat, forage at 0.30

ppm; wheat, grain at 0.01 ppm; wheat,

hay at 0.10 ppm; and wheat, straw at

0.05 ppm; and combined residues of

flucarbazone-sodium and its metabolites

converted to 2-

(trifluoromethoxy)benzene sulfonamide

and calculated as flucarbazone-sodium

in or on milk at 0.005 ppm; meat and

meat byproducts (excluding liver) of

cattle, goats, hogs, horses and sheep at

0.01 ppm; and liver of cattle, goats,

hogs, horses and sheep at 1.5 ppm.

VI. Objections and Hearing Requests

Under section 408(g) of the FFDCA, as

amended by the FQPA, any person may

file an objection to any aspect of this

regulation and may also request a

hearing on those objections. The EPA

procedural regulations which govern the

submission of objections and requests

for hearings appear in 40 CFR part 178.

Although the procedures in those

regulations require some modification to

reflect the amendments made to the

FFDCA by the FQPA of 1996, EPA will

continue to use those procedures, with

appropriate adjustments, until the

necessary modifications can be made.

The new section 408(g) provides

essentially the same process for persons

to ‘‘object’’ to a regulation for an

exemption from the requirement of a

tolerance issued by EPA under new

section 408(d), as was provided in the

old FFDCA sections 408 and 409.

However, the period for filing objections

is now 60 days, rather than 30 days.

Federal Register / Vol. 65, No. 190 / Friday, September 29, 2000 / Rules and Regulations 58373

A. What Do I Need to Do to File an

Objection or Request a Hearing?

You must file your objection or

request a hearing on this regulation in

accordance with the instructions

provided in this unit and in 40 CFR part

178. To ensure proper receipt by EPA,

you must identify docket control

number OPP–301052 in the subject line

on the first page of your submission. All

requests must be in writing, and must be

mailed or delivered to the Hearing Clerk

on or before November 28, 2000.

1. Filing the request. Your objection

must specify the specific provisions in

the regulation that you object to, and the

grounds for the objections (40 CFR

178.25). If a hearing is requested, the

objections must include a statement of

the factual issues(s) on which a hearing

is requested, the requestor’s contentions

on such issues, and a summary of any

evidence relied upon by the objector (40

CFR 178.27). 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.

Mail your written request to: Office of

the Hearing Clerk (1900), Environmental

Protection Agency, 1200 Pennsylvania

Ave., NW., Washington, DC 20460. You

may also deliver your request to the

Office of the Hearing Clerk in Rm. C400,

Waterside Mall, 401 M St., SW.,

Washington, DC 20460. The Office of

the Hearing Clerk is open from 8 a.m.

to 4 p.m., Monday through Friday,

excluding legal holidays. The telephone

number for the Office of the Hearing

Clerk is (202) 260–4865.

2. Tolerance fee payment. If you file

an objection or request a hearing, you

must also pay the fee prescribed by 40

CFR 180.33(i) or request a waiver of that

fee pursuant to 40 CFR 180.33(m). You

must mail the fee to: EPA Headquarters

Accounting Operations Branch, Office

of Pesticide Programs, P.O. Box

360277M, Pittsburgh, PA 15251. Please

identify the fee submission by labeling

it ‘‘Tolerance Petition Fees.’’

EPA is authorized to waive any fee

requirement ‘‘when in the judgement of

the Administrator such a waiver or

refund is equitable and not contrary to

the purpose of this subsection.’’ For

additional information regarding the

waiver of these fees, you may contact

James Tompkins by phone at (703) 305–

5697, by e-mail at

tompkins.jim@epa.gov, or by

mailing a request for information to Mr.

Tompkins at Registration Division

(7505C), Office of Pesticide Programs,

Environmental Protection Agency, 1200

Pennsylvania Ave., NW., Washington,

DC 20460.

If you would like to request a waiver

of the tolerance objection fees, you must

mail your request for such a waiver to:

James Hollins, Information Resources

and Services Division (7502C), Office of

Pesticide Programs, Environmental

Protection Agency, 1200 Pennsylvania

Ave., NW., Washington, DC 20460.

3. Copies for the Docket. In addition

to filing an objection or hearing request

with the Hearing Clerk as described in

Unit VI.A., you should also send a copy

of your request to the PIRIB for its

inclusion in the official record that is

described in Unit I.B.2. Mail your

copies, identified by docket control

number OPP–301052, to: Public

Information and Records Integrity

Branch, Information Resources and

Services Division (7502C), Office of

Pesticide Programs, Environmental

Protection Agency, 1200 Pennsylvania

Ave., NW., Washington, DC 20460. In

person or by courier, bring a copy to the

location of the PIRIB described in Unit

I.B.2. You may also send an electronic

copy of your request via e-mail to: oppdocket@epa.gov. Please use an

ASCII file format and avoid the use of

special characters and any form of

encryption. Copies of electronic

objections and hearing requests will also

be accepted on disks in WordPerfect

6.1/8.0 file format or ASCII file format.

Do not include any CBI in your

electronic copy. You may also submit an

electronic copy of your request at many

Federal Depository Libraries.

B. When Will the Agency Grant a

Request for a Hearing?

A request for a hearing will be granted

if the Administrator etermines that the

material submitted shows the following:

There is a 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(s) in the manner sought by the

requestor would be adequate to justify

the action requested (40 CFR 178.32).

VII. Regulatory Assessment

Requirements

This final rule establishes a tolerance

under FFDCA section 408(d) in

response to a petition submitted to the

Agency. The Office of Management and

Budget (OMB) has exempted these types

of actions from review under Executive

Order 12866, entitled Regulatory

Planning and Review (58 FR 51735,

October 4, 1993). This final rule does

not contain any information collections

subject to OMB approval under the

Paperwork Reduction Act (PRA), 44

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

enforceable duty or contain any

unfunded mandate as described under

Title II of the Unfunded Mandates

Reform Act of 1995 (UMRA) (Public

Law 104–4). Nor does it require any

prior consultation as specified by

Executive Order 13084, entitled

Consultation and Coordination with

Indian Tribal Governments (63 FR

27655, May 19, 1998); 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 or any

Agency action under Executive Order

13045, entitled Protection of Children

from Environmental Health Risks and

Safety Risks (62 FR 19885, April 23,

1997). This action does not involve any

technical standards that would require

Agency consideration of voluntary

consensus standards pursuant to section

12(d) of the National Technology

Transfer and Advancement Act of 1995

(NTTAA), Public Law 104–113, section

12(d) (15 U.S.C. 272 note). Since

tolerances and exemptions that are

established on the basis of a petition

under FFDCA section 408(d), such as

the tolerance in this final rule, do not

require the issuance of a proposed rule,

the requirements of the Regulatory

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

seq.) do not apply. In addition, the

Agency has determined that this action

will not have a substantial direct effect

on States, on the relationship between

the national government and the States,

or on the distribution of power and

responsibilities among the various

levels of government, as specified in

Executive Order 13132, entitled

Federalism (64 FR 43255, August 10,

1999). Executive Order 13132 requires

EPA to develop an accountable process

to ensure ‘‘meaningful and timely input

by State and local officials in the

development of regulatory policies that

have federalism implications.’’ ‘‘Policies

that have federalism implications’’ is

defined in the Executive Order to

include regulations that have‘‘

substantial direct effects on the States,

on the relationship between the national

government and the States, or on the

distribution of power and

58374 Federal Register / Vol. 65, No. 190 / Friday, September 29, 2000 / Rules and Regulations

responsibilities among the various

levels of government.’’ This final rule

directly regulates growers, food

processors, food handlers and food

retailers, not States. This action does not

alter the relationships or distribution of

power and responsibilities established

by Congress in the preemption

provisions of FFDCA section 408(n)(4).

VIII. 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 this final

rule in the Federal Register. This final

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: September 21, 2000.

Susan B. Hazen,

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. 321(q), (346a) and

371.

2. Section 180.562 is added to read as

follows:

§ 180.562 Flucarbazone-sodium;

tolerances for residues.

(a) General. (1) Time-limited

tolerances are established for combined

residues of the herbicide flucarbazonesodium, 4,5-dihydro-3-methoxy-4-

methyl-5-oxo-N-

[[2(trifluoromethoxy)phenyl] sulfonyl]-

1H-1,2,4-triazole 1-carboxamide,

sodium salt) and its N-desmethyl

metabolite in or on the following food

commodities:

Commodity Parts per million

Expiration/

Revocation

Date

Wheat, forage .............................................................................................................................................. 0.30 11/01/05

Wheat, grain ................................................................................................................................................ 0.01 11/01/05

Wheat, hay ................................................................................................................................................... 0.10 11/01/05

Wheat, straw ................................................................................................................................................ 0.05 11/01/05

(2) Time-limited tolerances are

established for combined residues of the

herbicide flucarbazone-sodium, 4,5-

dihydro-3-methoxy-4-methyl-5-oxo-N-

[[2(trifluoromethoxy)phenyl] sulfonyl]-

1H-1,2,4-triazole 1-carboxamide,

sodium salt) and its metabolites

converted to 2-

(trifluoromethoxy)benzene sulfonamide

and calculated as flucarbazone-sodium

in or on the following food

commodities:

Commodity Parts per million Expiration/

Revocation Date

Cattle, liver ................................................................................................................................................... 1.50 11/01/05

Cattle, mbyp except liver ............................................................................................................................. 0.01 11/01/05

Cattle, meat ................................................................................................................................................. 0.01 11/01/05

Goats, liver ................................................................................................................................................... 1.50 11/01/05

Goats, mbyp except liver ............................................................................................................................. 0.01 11/01/05

Goats, meat ................................................................................................................................................. 0.01 11/01/05

Hogs, liver .................................................................................................................................................... 1.50 11/01/05

Hogs, mbyp except liver .............................................................................................................................. 0.01 11/01/05

Hogs, meat .................................................................................................................................................. 0.01 11/01/05

Horses, liver ................................................................................................................................................. 1.50 11/01/05

Horses, mbyp except liver ........................................................................................................................... 0.01 11/01/05

Horses, meat ............................................................................................................................................... 0.01 11/01/05

Milk ............................................................................................................................................................... 0.005 11/01/05

Sheep, liver .................................................................................................................................................. 1.50 11/01/05

Sheep, mbyp except liver ............................................................................................................................ 0.01 11/01/05

Sheep, meat ................................................................................................................................................ 0.01 11/01/05

Federal Register / Vol. 65, No. 190 / Friday, September 29, 2000 / Rules and Regulations 58375

(b) Section 18 emergency exemptions.

[Reserved]

(c) Tolerances with regional

registrations. [Reserved]

(d) Indirect or inadvertent residues.

[Reserved]

FR Doc. 00–24947 Filed 9–28–00; 8:45 am]

BILLING CODE 6560–50–S

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Part 180

[OPP–301063; FRL–6744–8]

RIN 2070–AB78

Triallate,(S-2,3,3-trichloroallyl

diisopropylthiocarbamate); Pesticide

Tolerance

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Final rule.

SUMMARY: This regulation establishes a

tolerance for the combined residues of

the herbicide triallate (S-2,3,3,

trichloroallyl diisopropylthiocarbamate)

and its metabolite, TCPSA (2,3,3-

trichloroprop-2-ene sulfonic acid) in or

on sugar beet, root; sugar beet, top; and

sugar beet, pulp. Monsanto requested

this tolerance under the Federal Food,

Drug, and Cosmetic Act, as amended by

the Food Quality Protection Act of 1996.

DATES: This regulation is effective

September 29, 2000.Objections and

requests for hearings, identified by

docket control number OPP–301063,

must be received by EPA on or before

November 28, 2000.

ADDRESSES: Written objections and

hearing requests may be submitted by

mail, in person, or by courier. Please

follow the detailed instructions for each

method as provided in Unit VI. of the

SUPPLEMENTARY INFORMATION. To ensure

proper receipt by EPA, your objections

and hearing requests must identify

docket control number OPP–301063 in

the subject line on the first page of your

response.

FOR FURTHER INFORMATION CONTACT: By

mail: James A. Tompkins (PM 25),

Registration Division (7505C), Office of

Pesticide Programs, Environmental

Protection Agency, 1200 Pennsylvania

Ave., NW., Washington, DC 20460;

telephone number: 703 305–5697; and

e-mail address: Tompkins.Jim

@epamail.epa.gov.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

You may be affected by this action if

you are an agricultural producer, food

manufacturer, or pesticide

manufacturer. Potentially affected

categories and entities may include, but

are not limited to:

Categories NAICS

codes

Examples of potentially affected entities

Industry 111 Crop production

112 Animal production

311 Food manufacturing

32532 Pesticide manufacturing

This listing is not intended to be

exhaustive, but rather provides a guide

for readers regarding entities likely to be

affected by this action. Other types of

entities not listed in the table could also

be affected. The North American

Industrial Classification System

(NAICS) codes have been provided to

assist you and others in determining

whether or not this action might apply

to certain entities. If you have questions

regarding the applicability of this action

to a particular entity, consult the person

listed under FOR FURTHER INFORMATION

CONTACT.

B. How Can I Get Additional

Information, Including Copies of this

Document and Other Related

Documents?

1. Electronically .You may obtain

electronic copies of this document, and

certain other related documents that

might be available electronically, from

the EPA Internet Home Page at http://

www.epa.gov/. To access this

document, on the Home Page select

‘‘Laws and Regulations, ’’ ‘‘Regulations

and Proposed Rules,’’ and then look up

the entry for this document under the

‘‘Federal Register —Environmental

Documents.’’ You can also go directly to

the Federal Registerlistings at http://

www.epa.gov/fedrgstr/. To access the

OPPTS Harmonized Guidelines

referenced in this document, go directly

to the guidelines at http://www.epa.gov/

opptsfrs/home/guidelin.htm.

2. In person. The Agency has

established an official record for this

action under docket control number

OPP–301063. The official record

consists of the documents specifically

referenced in this action, and other

information related to this action,

including any information claimed as

Confidential Business Information (CBI).

This official record includes the

documents that are physically located in

the docket, as well as the documents

that are referenced in those documents.

The public version of the official record

does not include any information

claimed as CBI. The public version of

the official record, which includes

printed, paper versions of any electronic

comments submitted during an

applicable comment period is available

for inspection in the Public Information

and Records Integrity Branch (PIRIB),

Rm. 119, Crystal Mall #2, 1921 Jefferson

Davis Hwy., Arlington, VA, from 8:30

a.m. to 4 p.m., Monday through Friday,

excluding legal holidays. The PIRIB

telephone number is (703) 305–5805.

II. Background and Statutory Findings

In the Federal Register of May 16,

1997 (62 FR 27027) (FRL–5717–6), EPA

issued a notice pursuant to section 408

of the Federal Food, Drug, and Cosmetic

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

amended by the Food Quality Protection

Act of 1996 (FQPA) (Public Law 104–

170) announcing the filing of a pesticide

petition (PP 8F2128) for tolerance by

Monsanto, 600 13th St., NW., Suite 660,

Washington, DC 20005. This notice

included a summary of the petition

prepared by Monsanto, the registrant.

There were no comments received in

response to the notice of filing.

The petition requested that 40 CFR

180.314 be amended by establishing a

tolerance for residues of the herbicide

triallate, and its metabolite, TCPSA in or

on sugar beet root at 0.01 part per

million (ppm), sugar beet top at 0.5

ppm, and sugar beet pulp at 0.2 ppm

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. For