49158 Federal Register / Vol. 62, No. 182 / Friday, September 19, 1997 / Rules and Regulations

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 18, 1997. 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, Carbon monoxide,

Hydrocarbons, Incorporation by

reference, Intergovernmental relations,

Nitrogen dioxide, Ozone, Reporting and

recordkeeping requirements.

List of Subjects in 40 CFR Part 81

Environmental protection, Air

pollution control, National parks,

Wilderness areas.

Dated: September 5, 1997.

A. Stan Meiburg,

Acting Regional Administrator.

Chapter I, title 40, Code of Federal

Regulations, is amended as follows:

PART 52—[AMENDED]

1. The authority citation for part 52

continues to read as follows:

Authority: 42 U.S.C. 7401–7671q.

Subpart B—Alabama

2. Section 52.66 is added to read as

follows:

§ 52.66 Control Strategy: Ozone.

The redesignation request submitted

by the State of Alabama, on March 16,

1995 for the Birmingham marginal

ozone nonattainment area from

nonattainment to attainment was

disapproved on September 19, 1997.

[FR Doc. 97–24942 Filed 9–18–97; 8:45 am]

BILLING CODE 6560–50–P

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Part 180

[OPP–300550; FRL–5744–2]

RIN 2070–AB78

Cloransulam-methyl; Pesticide

Tolerances

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Final rule.

SUMMARY: This regulation establishes

tolerances for residues of cloransulammethyl in or on soybeans, soybean

forage and soybean hay. DowElanco

requested this tolerance under the

Federal Food, Drug and Cosmetic Act

(FFDCA), as amended by the Food

Quality Protection Act of 1996 (Pub. L.

104–170).

DATES: This regulation is effective

September 19, 1997. Objections and

requests for hearings must be received

by EPA on or before November 18, 1997.

ADDRESSES: Written objections and

hearing requests, identified by the

docket control number, [OPP–300550],

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–

300550], must also be submitted to:

Public Information and Records

Integrity Branch, Information Resources

and Services Division (7506C), Office of

Pesticide Programs, Environmental

Protection Agency, 401 M St., SW.,

Washington, DC 20460. In person, bring

a copy of objections and hearing

requests to Rm. 1132, CM #2, 1921

Jefferson Davis Hwy., Arlington, VA.

A copy of objections and hearing

requests filed with the Hearing Clerk

may also be submitted electronically by

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

objections and hearing requests must be

submitted as an ASCII file avoiding the

use of special characters and any form

of encryption. Copies of objections and

hearing requests will also be accepted

on disks in WordPerfect 5.1 file format

or ASCII file format. All copies of

objections and hearing requests in

electronic form must be identified by

the docket control number [OPP–

300550]. 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: James A. Tompkins, Registration

Division 7505C, Office of Pesticide

Programs, Environmental Protection

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

DC 20460. Office location, telephone

number, and e-mail address: Crystal

Mall #2, 1921 Jefferson Davis Hwy.,

Arlington, VA, (703) 305-5697, e-mail:

tompkins.jim@epamail.epa.gov.

SUPPLEMENTARY INFORMATION: In the

Federal Register of March 26, 1997 (52

FR 14421)(FRL–5592–8), EPA, issued a

notice pursuant to section 408 of the

Federal Food, Drug, and Cosmetic Act

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

the filing of a pesticide petition (PP)

5F4560 for tolerance by DowElanco,

9330 Zionville Road, Indianapolis, IN

46268-1054. This notice included a

summary of the petition prepared by

DowElanco. There were no comments

received in response to the notice of

filing.

The petition requested that 40 CFR

180 be amended by establishing

tolerances for residues of the herbicide

cloransulam-methyl, N-(2-

carboxymethyl-6-chlorophenyl)-5-

ethoxy-7-fluoro-(1,2,4)-triazolo[1,5c]-

pyrimidine-2-sulfonamide, in or on

soybean seed at 0.02 parts per million

(ppm), soybean forage at 0.1 ppm, and

soybean hay at 0.2 ppm. The tolerance

expression is being editorially amended

to read cloransulam-methyl plus its

acid, cloransulam, calculated as parent

ester.

I. Risk Assessment and Statutory

Findings

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

FFDCA allows EPA to establish a

tolerance (the legal limit for a pesticide

chemical residue in or on a food) only

if EPA determines that the tolerance is

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

‘‘safe’’ to mean that ‘‘there is a

reasonable certainty that no harm will

result from aggregate exposure to the

pesticide chemical residue, including

all anticipated dietary exposures and all

other exposures for which there is

reliable information.’’ This includes

exposure through drinking water and in

residential settings, but does not include

occupational exposure. Section

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

consideration to exposure of infants and

children to the pesticide chemical

residue in establishing a tolerance and

to ‘‘ensure that there is a reasonable
Federal Register / Vol. 62, No. 182 / Friday, September 19, 1997 / Rules and Regulations 49159

certainty that no harm will result to

infants and children from aggregate

exposure to the pesticide chemical

residue * * * ’’

EPA performs a number of analyses to

determine the risks from aggregate

exposure to pesticide residues. First,

EPA determines the toxicity of

pesticides based primarily on

toxicological studies using laboratory

animals. These studies address many

adverse health effects, including (but

not limited to) reproductive effects,

developmental toxicity, toxicity to the

nervous system, and carcinogenicity.

Second, EPA examines exposure to the

pesticide through the diet (e.g., food and

drinking water) and through exposures

that occur as a result of pesticide use in

residential settings.

A. Toxicity

1. Threshold and non-threshold

effects. For many animal studies, a dose

response relationship can be

determined, which provides a dose that

causes adverse effects (threshold effects)

and doses causing no observed effects

(the ‘‘no-observed effect level’’ or

‘‘NOEL’’).

Once a study has been evaluated and

the observed effects have been

determined to be threshold effects, EPA

generally divides the NOEL from the

study with the lowest NOEL by an

uncertainty factor (usually 100 or more)

to determine the Reference Dose (RfD).

The RfD is a level at or below which

daily aggregate exposure over a lifetime

will not pose appreciable risks to

human health. An uncertainty factor

(sometimes called a ‘‘safety factor’’) of

100 is commonly used since it is

assumed that people may be up to 10

times more sensitive to pesticides than

the test animals, and that one person or

subgroup of the population (such as

infants and children) could be up to 10

times more sensitive to a pesticide than

another. In addition, EPA assesses the

potential risks to infants and children

based on the weight of the evidence of

the toxicology studies and determines

whether an additional uncertainty factor

is warranted. Thus, an aggregate daily

exposure to a pesticide residue at or

below the RfD (expressed as 100 percent

or less of the RfD) is generally

considered acceptable by EPA. EPA

generally uses the RfD to evaluate the

chronic risks posed by pesticide

exposure. For shorter term risks, EPA

calculates a margin of exposure (MOE)

by dividing the estimated human

exposure into the NOEL from the

appropriate animal study. Commonly,

EPA finds MOEs lower than 100 to be

unacceptable. This 100-fold MOE is

based on the same rationale as the 100-

fold uncertainty factor.

Lifetime feeding studies in two

species of laboratory animals are

conducted to screen pesticides for

cancer effects. When evidence of

increased cancer is noted in these

studies, the Agency conducts a weight

of the evidence review of all relevant

toxicological data including short-term

and mutagenicity studies and structure

activity relationship. Once a pesticide

has been classified as a potential human

carcinogen, different types of risk

assessments (e.g., linear low dose

extrapolations or MOE calculation based

on the appropriate NOEL) will be

carried out based on the nature of the

carcinogenic response and the Agency’s

knowledge of its mode of action.

2. Differences in toxic effect due to

exposure duration. The toxicological

effects of a pesticide can vary with

different exposure durations. EPA

considers the entire toxicity data base,

and based on the effects seen for

different durations and routes of

exposure, determines which risk

assessments should be done to assure

that the public is adequately protected

from any pesticide exposure scenario.

Both short and long durations of

exposure are always considered.

Typically, risk assessments include

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

term’’, and ‘‘chronic’’ risks. These

assessments are defined by the Agency

as follows.

Acute risk, by the Agency’s definition,

results from 1-day consumption of food

and water, and reflects toxicity which

could be expressed following a single

oral exposure to the pesticide residues.

High end exposure to food and water

residues are typically assumed.

Short-term risk results from exposure

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

and therefore overlaps with the acute

risk assessment. Historically, this risk

assessment was intended to address

primarily dermal and inhalation

exposure which could result, for

example, from residential pesticide

applications. However, since enaction of

FQPA, this assessment has been

expanded to include both dietary and

non-dietary sources of exposure, and

will typically consider exposure from

food, water, and residential uses when

reliable data are available. In this

assessment, risks from average food and

water exposure, and high-end

residential exposure, are aggregated.

High-end exposures from all 3 sources

are not typically added because of the

very low probability of this occurring in

most cases, and because the other

conservative assumptions built into the

assessment assure adequate protection

of public health. However, for cases in

which high-end exposure can

reasonably be expected from multiple

sources (e.g. frequent and widespread

homeowner use in a specific

geographical area), multiple high-end

risks will be aggregated and presented

as part of the comprehensive risk

assessment/characterization. Since the

toxicological endpoint considered in

this assessment reflects exposure over a

period of at least 7 days, an additional

degree of conservatism is built into the

assessment; i.e., the risk assessment

nominally covers 1-7 days exposure,

and the toxicological endpoint/NOEL is

selected to be adequate for at least 7

days of exposure. (Toxicity results at

lower levels when the dosing duration

is increased.)

Intermediate-term risk results from

exposure for 7 days to several months.

This assessment is handled in a manner

similar to the short-term risk

assessment.

Chronic risk assessment describes risk

which could result from several months

to a lifetime of exposure. For this

assessment, risks are aggregated

considering average exposure from all

sources for representative population

subgroups including infants and

children.

B. Aggregate Exposure

In examining aggregate exposure,

FFDCA section 408 requires that EPA

take into account available and reliable

information concerning exposure from

the pesticide residue in the food in

question, residues in other foods for

which there are tolerances, residues in

groundwater or surface water that is

consumed as drinking water, and other

non-occupational exposures through

pesticide use in gardens, lawns, or

buildings (residential and other indoor

uses). Dietary exposure to residues of a

pesticide in a food commodity are

estimated by multiplying the average

daily consumption of the food forms of

that commodity by the tolerance level or

the anticipated pesticide residue level.

The Theoretical Maximum Residue

Contribution (TMRC) is an estimate of

the level of residues consumed daily if

each food item contained pesticide

residues equal to the tolerance. In

evaluating food exposures, EPA takes

into account varying consumption

patterns of major identifiable subgroups

of consumers, including infants and

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

estimate since it is based on the

assumptions that food contains

pesticide residues at the tolerance level

and that 100% of the crop is treated by

pesticides that have established

tolerances. If the TMRC exceeds the RfD
49160 Federal Register / Vol. 62, No. 182 / Friday, September 19, 1997 / Rules and Regulations

or poses a lifetime cancer risk that is

greater than approximately one in a

million, EPA attempts to derive a more

accurate exposure estimate for the

pesticide by evaluating additional types

of information (anticipated residue data

and/or percent of crop treated data)

which show, generally, that pesticide

residues in most foods when they are

eaten are well below established

tolerances.

Percent of crop treated estimates are

derived from Federal and private market

survey data. Typically, a range of

estimates are supplied and the upper

end of this range is assumed for the

exposure assessment. By using this

upper end estimate of percent of crop

treated, the Agency is reasonably certain

that exposure is not understated for any

significant subpopulation group.

Further, regional consumption

information is taken into account

through EPA’s computer-based model

for evaluating the exposure of

significant subpopulations including

several regional groups, to pesticide

residues. For this pesticide, the most

highly exposed population subgroup

(non-nursing infants <1 year old) was

not regionally based.

II. Aggregate Risk Assessment and

Determination of Safety

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

EPA has reviewed the available

scientific data and other relevant

information in support of this action,

EPA has sufficient data to assess the

hazards of cloransulam-methyl, N-(2-

carboxymethyl-6-chlorophenyl)-5-

ethoxy-7-fluoro-(1,2,4)-triazolo[1,5c]-

pyrimidine-2-sulfonamide, and to make

a determination on aggregate exposure,

consistent with section 408(b)(2),

tolerances for residues of cloransulammethyl plus its acid, cloransulam,

calculated as parent ester on soybean

seed at 0.02 ppm, soybean forage at 0.1

ppm, and soybean hay at 0.2 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 cloransulammethyl are discussed below.

1. A rat acute oral study with a LD50

greater than 5,000 milligrams (mg)/

kilogram (kg) for males and for females.

2. A 90–day mouse feeding study with

a No Observed Effect Level (NOEL) of 50

mg/kg/day for males and a Lowest

Observed Effect Level (LOEL) of 100

mg/kg/day for males based on increased

levels of alkaline phosphatase and

increased liver weights and an increase

in the size of hepatocytes.

3. A 21–day rabbit dermal study with

a Dermal Irritation NOEL greater than

1,000 mg/kg/day for males and females

and with a Systemic NOEL of 500 mg/

kg/day (males and females) and a

Systemic LOEL of 1,000 mg/kg/day

based on decreased red cell count,

hemoglobin and hematocrit,

anisocytosis and macrocytosis of red

cells for females.

4. A carcinogenicity study in mice

with a NOEL of 10 mg/kg/day for both

sexes and a LOEL of 100 mg/kg/day

(males and females) based on a decrease

in renal tubule vacuolation in male

mice, increased size of centrilobular and

midzonal hepatocytes accompanied by

altered tinctorial properties in females

and centrilobular hepatocyte

hypertrophy in males. Total tumor

incidence (adenoma + carcinoma) was

not increased by dosing with

cloransulam-methyl.

5. A rat chronic feeding/

carcinogenicity study with a NOEL of 75

mg/kg/day and LOEL of 325 mg/kg/day

for both sexes based on significant

increase in hemoglobin, hematocrit, and

red cell count in males, activities of the

liver enzymes aspartate and alanine

aminotransferase as well as alkaline

phosphatase were decreased in males,

cholesterol was decreased in females,

specific gravity of urine was decreased

in females, increased relative wight in

liver and relative weight of testes in

males, males exhibited an increased

incidence of collecting duct

hypertrophy and females exhibited

increased incidence of vacuolation in

the kidney. There was no evidence of

carcinogenicity for cloransulam-methyl

in this study.

6. A dog chronic feeding study with

a NOEL of 10 mg/kg/day and a LOEL of

50 mg/kg/day based on hepatocellular

hypertrophy and accumulation of

pigment, and increased activity of

alkaline phosphatase and alanine

aminotransferase liver enzymes and

decrease in albumin and total bilirubin.

7. A two-generation reproduction

study in rats with a Parental Systemic

Toxicity NOEL of 10 mg/kg/day and a

Parental Systemic Toxicity LOEL of 100

mg/kg/day ppm based on hypertrophy

of the collecting ducts and vacuolation

consistent with fatty changes. The

Reproductive and Developmental NOEL

is 100 mg/kg/day and the Reproductive

and Developmental LOEL is 500 mg/kg/

day based on decreased live pups and

increased pup deaths.

8. A developmental toxicity study in

rabbits with a Maternal NOEL of 100

mg/kg/day and Developmental NOEL of

300 mg/kg/day (Highest Dose Tested

[HDT]) and a Maternal LOEL of 300 mg/

kg/day based on reduced weight gain,

food efficiency, increased abortions, and

cesarean section observations.

9. A developmental toxicity study in

rats with a Maternal NOEL and

Developmental NOEL of 1,000 mg/kg/

day (HDT).

10. In a mouse micronucleus assay no

lethality or evidence of target tissue

cytotoxicity and no significant increase

in frequency of micro nucleated

polychromatic erythrocytes were

observed. In two cytogenetic assays,

cloransulam-methyl did not induce

either cytotoxic or clastogenic effects in

rat lymphocytes. In a cultured chinese

hamster ovary cell study, cloransulammethyl was neither cytotoxic nor

mutagenic.

11. A rat metabolism study showed

that radio labeled cloransulam-methyl

was excreted mainly via urine in

females and urine and feces in males.

Less than 0.1% of administered dose

was found in any tissue at 72 hours

post-dose.

B. Toxicological Endpoints

1. Acute toxicity. EPA has concluded

that a risk estimate is not required since

no endpoint exists to suggest any

evidence of significant toxicity from

one-day or single-event exposure.

2. Short - term and intermediate -

term toxicity. EPA has concluded that

available evidence does not indicate any

evidence of significant toxicity from

short and intermediate term exposure.

3. Chronic toxicity. EPA has

established the RfD for cloransulammethyl at 0.1 milligrams/kilogram/day

(mg/kg/day). This RfD is based on the

systemic NOEL of 10 mg/kg/day in the

dog chronic feeding study with a 100-

fold safety factor to account for

interspecies extrapolation and

intraspecies variability.

4. Carcinogenicity. The Health Effects

Division Carcinogenicity Peer Review

Committee has classified cloransulammethyl as ‘‘not likely’’ to be

carcinogenic to humans based on the

lack of carcinogenicity in rats and mice.

C. Exposures and Risks

1. From food and feed uses. The

proposed tolerances would be the first

tolerances established in 40 CFR part

180 for the residues of cloransulam-
Federal Register / Vol. 62, No. 182 / Friday, September 19, 1997 / Rules and Regulations 49161

methyl plus its acid, cloransulam,

calculated as parent ester in or on raw

agricultural commodities. Risk

assessments were conducted by EPA to

assess dietary exposures and risks from

cloransulam-methyl as follows:

The dietary risk assessment uses very

conservative assumptions that 100% of

the soybeans will contain cloransulammethyl residues and that these residues

would be at the tolerance level. The

theoretical maximum residue

contribution (TMRC) from the proposed

tolerances is 0.000007 mg/kg/day and

utilizes 0.007 percent of the RfD for the

overall U. S. population. For exposure

of the most highly exposed subgroup in

the population, non-nursing infants, the

TMRC is 0.000033 mg/kg/day which

utilizes 0.033 percent of the RfD.

2. From drinking water. Cloransulammethyl concentration in surface water

has been estimated by using the Generic

Expected Environmental Concentrations

(GENEEC) model. The worst case

exposure estimate for surface water is

1.83 parts per billion (ppb). Based on

the estimated exposures to Cloransulammethyl from drinking water, the

percentage of the RfD utilized for a child

would be 0.183% of the Reference Dose

(RfD). The exposure for a female would

be 0.061% of the RfD.

3. From non-dietary exposure. There

are no non-food uses of cloransulammethyl currently registered under the

Federal Insecticide, Fungicide and

Rodenticide Act, as amended. No nondietary exposures are expected for the

general population.

4. Cumulative exposure to substances

with common mechanism of toxicity.

Cloransulam-methyl is a

triazolopyrimidine sulfonamide

herbicide. Another member of this class

is Flumetsulam. Section 408(b)(2)(D)(v)

requires that, when considering whether

to establish, modify, or revoke a

tolerance, the Agency consider

‘‘available information’’ concerning the

cumulative effects of a particular

pesticide’s residues and ‘‘other

substances that have a common

mechanism of toxicity.’’ The Agency

believes that ‘‘available information’’ in

this context might include not only

toxicity, chemistry, and exposure data,

but also scientific policies and

methodologies for understanding

common mechanisms of toxicity and

conducting cumulative risk

assessments. For most pesticides,

although the Agency has some

information in its files that may turn out

to be helpful in eventually determining

whether a pesticide shares a common

mechanism of toxicity with any other

substances, EPA does not at this time

have the methodologies to resolve the

complex scientific issues concerning

common mechanism of toxicity in a

meaningful way. EPA has begun a pilot

process to study this issue further

through the examination of particular

classes of pesticides. The Agency hopes

that the results of this pilot process will

increase the Agency’s scientific

understanding of this question such that

EPA will be able to develop and apply

scientific principles for better

determining which chemicals have a

common mechanism of toxicity and

evaluating the cumulative effects of

such chemicals. The Agency anticipates,

however, that even as its understanding

of the science of common mechanisms

increases, decisions on specific classes

of chemicals will be heavily dependent

on chemical specific data, much of

which may not be presently available.

Although at present the Agency does

not know how to apply the information

in its files concerning common

mechanism issues to most risk

assessments, there are pesticides as to

which the common mechanism issues

can be resolved. These pesticides

include pesticides that are

toxicologically dissimilar to existing

chemical substances (in which case the

Agency can conclude that it is unlikely

that a pesticide shares a common

mechanism of activity with other

substances) and pesticides that produce

a common toxic metabolite (in which

case common mechanism of activity

will be assumed).

EPA does not have, at this time,

available data to determine whether

cloransulam-methyl 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, cloransulammethyl 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 cloransulam-methyl has a

common mechanism of toxicity with

other substances.

D. Aggregate Risks and Determination of

Safety for U.S. Population

1. Acute, short-term, and

intermediate-term risk. EPA has

concluded that no endpoint exists to

suggest any evidence of significant

toxicity from acute, short-term or

intermediate-term exposures from the

use of cloransulam-methyl on soybeans.

2. Chronic risk. Using the

conservative exposure assumptions

described above, EPA has concluded

that aggregate exposure to cloransulammethyl from food and drinking water

will utilize less than 0.061% of the RfD

for females 20 years old (not pregnant -

not nursing). For the major identifiable

subgroup with the highest aggregate

exposure, non-nursing infants, the

aggregate exposure to cloransulammethyl from food and drinking water

will utilize less than 0.216% of the RfD.

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.

E. Aggregate Cancer Risk for U.S.

Population

EPA has classified cloransulammethyl as ‘‘not likely’’ to be

carcinogenic to humans based on the

lack of carcinogenicity in rats and mice.

F. Aggregate Risks and Determination of

Safety for Infants and Children

1. Safety factor for infants and

children. a. In general. In assessing the

potential for additional sensitivity of

infants and children to residues of

cloransulam-methyl, EPA considered

data from developmental toxicity

studies in the rat and rabbit and a twogeneration reproduction study in the rat.

The developmental toxicity studies are

designed to evaluate adverse effects on

the developing organism resulting from

pesticide exposure during prenatal

development to one or both parents.

Reproduction studies provide

information relating to effects from

exposure to the pesticide on the

reproductive capability of mating

animals and data on systemic toxicity.

FFDCA section 408 provides that EPA

shall apply an additional tenfold margin

of safety for infants and children in the

case of threshold effects to account for

pre- and post-natal toxicity and the

completeness of the database unless

EPA determines that a different margin

of safety will be safe for infants and

children. Margins of safety are

incorporated into EPA risk assessments

either directly through use of a MOE

analysis or through using uncertainty

(safety) factors in calculating a dose

level that poses no appreciable risk to

humans. EPA believes that reliable data

support using the standard MOE and

uncertainty factor (usually 100 for

combined inter- and intra-species

variability) and not the additional

tenfold MOE/uncertainty factor when

EPA has a complete data base under

existing guidelines and when the

severity of the effect in infants or

children or the potency or unusual toxic

properties of a compound do not raise
49162 Federal Register / Vol. 62, No. 182 / Friday, September 19, 1997 / Rules and Regulations

concerns regarding the adequacy of the

standard MOE/safety factor.

b. Developmental and Reproductive

toxicity studies. The pre- and post-natal

toxicology data base for cloransulammethyl is complete with respect to

current toxicological data requirements.

The results of these studies indicate that

infants and children are not more

sensitive to exposure, based on the

results of the oral rat and rabbit

developmental toxicity studies and the

2-generation reproductive toxicity study

in rats. Therefore, EPA concludes that

an additional ten-fold safety factor is not

necessary.

2. Chronic risk. Using the

conservative exposure assumptions

described above, EPA has concluded

that aggregate exposure to cloransulammethyl from food and drinking water

will utilize less than 0.216% of the RfD

for infants and children. EPA generally

has no concern for exposures below

100% of the RfD because the RfD

represents the level at or below which

daily aggregate dietary exposure over a

lifetime will not pose appreciable risks

to human health. EPA concludes that

there is a reasonable certainty that no

harm will result to infants and children

from aggregate exposure to cloransulammethyl residues.

III. Other Considerations

A. Metabolism In Plants and Animals

The metabolism of cloransulammethyl in plants and animals is

adequately understood for purposes of

this tolerance.

B. Analytical Enforcement Methodology

An adequate analytical method,

Capillary Gas Chromatography with

Mass Spectrometry is available for

enforcement purposes. Because of the

long lead time from establishing these

tolerances to publication of the

enforcement methodology in the

Pesticide Analytical Manual, Vol. II, the

analytical methodology is being made

available in the interim to anyone

interested in pesticide enforcement

when requested from: Calvin Furlow,

Public Information and Records

Integrity Branch, Information Resources

and Services Division (7506C), Office of

Pesticide Programs, Environmental

Protection Agency, 401 M St., SW.,

Washington, DC 20460. Office location

and telephone number: Room 1130A,

CM #2, 1921 Jefferson Davis Highway,

Arlington, VA 22202, (703–305–5937).

C. Magnitude of Residues

The nature of the residue in plants is

adequately understood for the purposes

of this tolerance. Based on the results of

animal metabolism studies it is unlikely

that significant residues would occur in

secondary animal commodities from

this use.

D. Rotational Crop Restrictions

No tolerances for inadvertent residues

of cloransulam-methyl are required in

rotational crops. The restrictions that

appear on the labeling proposed for

registration under the Federal

Insecticide Fungicide and Rodenticide

Act (FIFRA), as amended, are due to

potential of phytotoxicity to susceptible

plants.

E. International Residue Limits

There are no Codex Alimentarius

Commission (Codex) Maximum Residue

Levels (MRLs) for cloransulam-methyl.

IV. Conclusion

The analysis for cloransulam-methyl

using tolerance level residues for all

population subgroups examined by EPA

shows the use on soybeans will not

cause exposure at which the Agency

believes there is an appreciable risk.

Based on the information cited above,

EPA has determined that establishing

tolerances for residues of cloransulammethyl plus its acid, cloransulam,

calculated as parent ester in or on

soybean seed at 0.02 parts per million

(ppm), soybean forage at 0.1 ppm, and

soybean hay at 0.2 ppm will be safe;

therefore, the tolerances are established

as set forth below.

V. Objections and Hearing Requests

The new FFDCA section 408(g)

provides essentially the same process

for persons to ‘‘object’’ to a tolerance

regulation issued by EPA under new

section 408(e) and (l)(6) as was provided

in the old section 408 and in section

409. However, the period for filing

objections is 60 days, rather than 30

days. EPA currently has procedural

regulations which govern the

submission of objections and hearing

requests. These regulations will require

some modification to reflect the new

law. However, until those modifications

can be made, EPA will continue to use

those procedural regulations with

appropriate adjustments to reflect the

new law.

Any person may, by November 18,

1997, file written objections to any

aspect of this regulation and may also

request a hearing on those objections.

Objections and hearing requests must be

filed with the Hearing Clerk, at the

address given above (40 CFR 178.20). A

copy of the objections and/or hearing

requests filed with the Hearing Clerk

should be submitted to the OPP docket

for this rulemaking. The objections

submitted must specify the provisions

of the regulation deemed objectionable

and the grounds for the objections (40

CFR 178.25). Each objection must be

accompanied by the fee prescribed by

40 CFR 180.33(i). If a hearing is

requested, the objections must include a

statement of the factual issues on which

a hearing is requested, the requestor’s

contentions on such issues, and a

summary of any evidence relied upon

by the requestor (40 CFR 178.27). A

request for a hearing will be granted if

the Administrator determines that the

material submitted shows the following:

There is genuine and substantial issue

of fact; there is a reasonable possibility

that available evidence identified by the

requestor would, if established, resolve

one or more of such issues in favor of

the requestor, taking into account

uncontested claims or facts to the

contrary; and resolution of the factual

issues in the manner sought by the

requestor would be adequate to justify

the action requested (40 CFR 178.32).

Information submitted in connection

with an objection or hearing request

may be claimed confidential by marking

any part or all of that information as

Confidential Business Information (CBI).

Information so marked will not be

disclosed except in accordance with

procedures set forth in 40 CFR part 2.

A copy of the information that does not

contain CBI must be submitted for

inclusion in the public record.

Information not marked confidential

may be disclosed publicly by EPA

without prior notice.

VI. Public Docket

EPA has established a record for this

rulemaking under docket control

number [OPP–300550] (including any

comments and data submitted

electronically). A public version of this

record, including printed, paper

versions of electronic comments, which

does not include any information

claimed as CBI, is available for

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

Monday through Friday, excluding legal

holidays. The public record is located in

Room 1132 of the Public Information

and Records Integrity Branch,

Information Resources and Services

Division (7506C), Office of Pesticide

Programs, Environmental Protection

Agency, Crystal Mall #2, 1921 Jefferson

Davis Highway, Arlington, VA.

Electronic comments may be sent

directly to EPA at:

opp-docket@epamail.epa.gov.

Electronic comments must be

submitted as an ASCII file avoiding the

use of special characters and any from

of encryption.
Federal Register / Vol. 62, No. 182 / Friday, September 19, 1997 / Rules and Regulations 49163

The official record for this

rulemaking, as well as the public

version, as described above will be kept

in paper form. Accordingly, EPA will

transfer any copies of objections and

hearing requests received electronically

into printed, paper form as they are

received and will place the paper copies

in the official rulemaking record which

will also include all comments

submitted directly in writing. The

official rulemaking record is the paper

record maintained at the Virginia

address in ‘‘ADDRESSES’’ at the

beginning of this document.

VII. Regulatory Assessment

Requirements

This final rule establishes tolerances

under FFDCA section 408(d) in

response to a petition submitted to the

Agency. The Office of Management and

Budget (OMB) has exempted these types

of actions from review under Executive

Order 12866, entitled Regulatory

Planning and Review (58 FR 51735,

October 4, 1993). This final rule does

not contain any information collections

subject to OMB approval under the

Paperwork Reduction Act (PRA), 44

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

enforceable duty or contain any

unfunded mandate as described under

Title II of the Unfunded Mandates

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

104-4). Nor does it require any prior

consultation as specified by Executive

Order 12875, entitled Enhancing the

Intergovernmental Partnership (58 FR

58093, October 28, 1993), or special

considerations as required by Executive

Order 12898, entitled Federal Actions to

Address Environmental Justice in

Minority Populations and Low-Income

Populations (59 FR 7629, February 16,

1994), or require OMB review in

accordance with Executive Order 13045,

entitled Protection of Children from

Environmental Health Risks and Safety

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

In addition, since these tolerances and

exemptions that are established on the

basis of a petition under FFDCA section

408(d), such as the 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 actions published on May 4,

1981 (46 FR 24950) and was provided

to the Chief Counsel for Advocacy of the

Small Business Administration.

VIII. Submission to Congress and the

General Accounting Office

Under 5 U.S.C. 801(a)(1)(A), as added

by the Small Business Regulatory

Enforcement Fairness Act of 1996, the

Agency has submitted a report

containing this rule and other required

information to the U.S. Senate, the U.S.

House of Representatives, and the

Comptroller General of the General

Accounting Office prior to publication

of this rule in today’s Federal Register.

This is not a ‘‘major rule’’ as defined by

5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

Environmental protection,

Administrative practice and procedure,

Agricultural commodities, Pesticides

and pests, Reporting and recordkeeping

requirements.

Dated: August 29, 1997.

Daniel M. Barolo,

Director, Office of Pesticide Programs.

Therefore, 40 CFR chapter I is

amended as follows:

PART 180—[AMENDED]

1. The authority citation for part 180

continues to read as follows:

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

2. By adding § 180.514 to read as

follows:

§ 180.514 Cloransulam-methyl; tolerances

for residues.

(a) General. Tolerances are

established for residues of the herbicide,

cloransulam-methyl, N-(2-

carboxymethyl-6-chlorophenyl)-5-

ethoxy-7-fluoro-(1,2,4)-triazolo[1,5c]-

pyrimidine-2-sulfonamide, plus its acid,

cloransulam, calculated as parent ester

in or on the following raw agricultural

commodities:

Commodity Parts per

million

Soybean, forage ....................... 0.1

Soybean, hay ............................ 0.2

Soybean seed ........................... 0.02

(b) Section 18 emergency exemptions.

[Reserved]

(c) Tolerances with regional

registrations. [Reserved]

(d) Indirect or inadvertent residues.

[Reserved]

[FR Doc. 97–24939 Filed 9–18–97; 8:45 am]

BILLING CODE 6560–50–F

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Parts 271 and 272

[FRL–5871–3]

Texas:Final Authorization and

Incorporation by Reference of State

Hazardous Waste Management

Program

AGENCY: Environmental Protection

Agency (EPA)

ACTION: Immediate final rule.

SUMMARY: Texas has revised its

hazardous waste program under the

Resource Conservation and Recovery

Act (RCRA). The EPA has reviewed

Texas’ changes to its program and has

made a decision, subject to public

review and comment, that Texas’

hazardous waste program revisions

satisfy all of the requirements necessary

to qualify for final authorization. Unless

adverse written comments are received

during the review and comment period

provided for public participation in this

process, EPA intends to approve Texas’

hazardous waste program revisions.

Texas’ program revisions are available

for public review and comment. In

addition, today’s document corrects

technical errors made in the table of

authorities published in the May 24,

1990, April 11, 1994 and April 12, 1994

authorization notices for Texas.

The EPA uses part 272 of Title 40

Code of Federal Regulations (CFR) to

provide notice of the authorization

status of State programs, and to

incorporate by reference those

provisions of the State statutes and

regulations that EPA will enforce under

RCRA Sections 3008, 3013 and 7003.

Thus, EPA intends to codify the Texas

authorized State program in 40 CFR part

272. The purpose of this action is to

incorporate by reference EPA’s approval

of Texas’ base hazardous waste program

and its revisions to that program.

DATES: Final authorization for Texas’

program revisions shall be effective

December 3, 1997 unless EPA publishes

a prior Federal Register action

withdrawing this immediate final rule.

All comments on Texas’ program

revisions must be received by the close

of business November 3, 1997. The

corrections to the May 24, 1990, April

11, 1994, and April 12, 1994

authorization notices go into effect

immediately. The incorporation by

reference of certain Texas statutes and

regulations was approved by the

Director of the Federal Register as of

December 3, 1997 in accordance with 5

U.S.C. 552(a) and 1 CFR part 51.