Federal Register / Vol. 62, No. 70 / Friday, April 11, 1997 / Rules and Regulations 17735

IX. Regulatory Assessment

Requirements

Under Executive Order 12866 (58 FR

51735, October 4, 1993), this action is

not a ‘‘significant regulatory action’’

and, since this action does not impose

any information collection requirements

as defined by the Paperwork Reduction

Act, 44 U.S.C. 3501 et seq., it is not

subject to review by the Office of

Management and Budget. In addition,

this action does not impose any

enforceable duty or contain any

unfunded mandate as described in the

Unfunded Mandates Reform Act of 1995

(Pub. L. 104–4), or require prior

consultation with State officials as

specified by Executive Order 12875 (58

FR 58093, October 28, 1993), or special

considerations as required by Executive

Order 12898 (59 FR 7629, February 16,

1994). Because FFDCA section 408(l)(6)

permits establishment of this regulation

without a notice of proposed

rulemaking, the regulatory flexibility

analysis requirements of the Regulatory

Flexibility Act, 5 U.S.C. 604(a), do not

apply.

Under 5 U.S.C. 801(a)(1)(A) of the

Small Business Regulatory Enforcement

Fairness Act of 1996 (Title II of Pub. L.

104–121, 110 Stat. 847), EPA 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 the rule in today’s Federal Register.

This rule is not a ‘‘major rule’’ as

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

List of Subjects

40 CFR Part 180

Environmental protection,

Administrative practice and procedure,

Agricultural commodities, Pesticides

and pests, Reporting and recordkeeping

requirements.

40 CFR Part 185

Environmental protection, Food and

additives, Pesticides and pest.

40 CFR Part 186

Environmental protection, Animal

feeds Pesticides and pest.

Dated: April 4, 1997.

Penelope A. Fenner-Crisp,

Acting Director, Office of Pesticide Programs.

Therefore, 40 CFR chapter I is

amended as follows:

PART 180—[AMENDED]

1. In part 180:

a. The authority citation for part 180

continues to read as follows:

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

b. Section 180.443 is amended as

follows:

i. In paragraph (a) by adding the

heading.

ii. In paragraph (b) by transferring and

alphabetically adding the entry in the

table to the table in paragraph (a) and by

removing the remaining text.

iii. In paragraph (c) by transferring

and alphabetically adding the entries in

the table to the table in paragraph (a)

and by removing the remaining text.

iv. By redesignating paragraph (d) as

paragraph (b) and by revising newly

redesignated paragraph (b).

v. By adding the headings and

reserving new paragraphs (c) and (d).

§ 180.443 Myclobutanil; tolerances for

residues.

(a) General. * * *

(b) Section 18 emergency exemptions.

Time-limited tolerances are established

for residues of the fungicide

myclobutanil, in connection with use of

the pesticide under section 18

emergency exemption granted by EPA.

The tolerances are specified in the

following table. These tolerances expire

and are automatically revoked on the

date specified in the table.

Commodity Parts per

million

Expiration/Revocation

Date

Cucurbit vegetables ..................................................................................................................................... 0.3 November 30, 1997

Strawberries ................................................................................................................................................. 0.5 March 31, 1998

(c) Tolerances with regional

registrations. [Reserved]

(d) Indirect or inadvertent residues.

[Reserved]

PART 185—[AMENDED]

2. In part 185:

a. The authority citation for part 185

continues to read as follows:

Authority: 21 U.S.C. 346a and 348.

§ 185.4350 [Removed]

b. The entries in the table to

§ 185.4350 are transferred and added

alphabetically to the table in paragraph

(a) of § 180.443; the remainder of

§ 185.4350 is removed.

PART 186—[AMENDED]

3. In part 186:

a. The authority citation for part 186

continues to read as follows:

Authority: 21 U.S.C.342, 348, and 701.

§ 186.4350 [Removed]

b. The entries in the table to

§ 186.4350 are transferred and added

alphabetically to the table in paragraph

(a) of § 180.443; the remainder of

§ 186.4350 is removed.

[FR Doc. 97–9378 Filed 4–11–97; 8:45 am]

BILLING CODE 6560–50–F

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Parts 180, 185, and 186

[OPP–300467; FRL–5598–7]

RIN 2070–AB78

Sethoxydim; Extension of Time-limited

Pesticide Tolerance

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Final rule.

SUMMARY: This document extends the

effective dates for the established timelimited tolerances for combined

residues of the herbicide 2-[1-

(ethoxyimino)butyl]-5-[2-

(ethylthio)propyl]-3-hydroxy-2-

cyclohexen-1-one (also referred to in

this document as sethoxydim) and its

metabolites in or on various raw

agricultural commodities. The

Interregional Research Project Number 4

(IR-4) requested these time extensions

under the Federal Food, Drug and

Cosmetic Act, as amended by the Food

Quality Protection Act of 1996.

DATES: This regulation becomes

effective April 11, 1997. Objections and

hearing request must be received by

June 10, 1997.

ADDRESSES: Written objections and

hearing requests, identified by the

docket control number, [OPP–300467;

PP 0E3909, 2E4052, 2E4065, 2E4092,

and 3E4162], may be submitted to:

Hearing Clerk (1900), Environmental

Protection Agency, Rm. M3708, 401 M
17736 Federal Register / Vol. 62, No. 70 / Friday, April 11, 1997 / Rules and Regulations

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 should be

identified by the docket control number

and submitted to: Public Response and

Program Resources Branch, Field

Operations Division (7506C), Office of

Pesticide Programs, Environmental

Protection Agency, 401 M St., SW.,

Washington, DC 20460. In person, bring

copy of objections and hearing requests

to: Rm. 1132, CM #2, 1921 Jefferson

Davis Highway, Arlington, VA 22202.

A copy of objections and hearing

requests filed with the Hearing Clerk

may also be submitted electronically to

the OPP by sending electronic mail (email) to: opp-docket@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 in 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–

300467; PP 0E3909, 2E4052, 2E4065,

2E4092, and 3E4162]. 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.

Additional information on electronic

submissions can be found in Unit IV. of

this document.

FOR FURTHER INFORMATION CONTACT: By

mail: Hoyt L. Jamerson, Registration

Division (7505W), Office of Pesticide

Programs, Environmental Protection

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

DC 20460. Office location, telephone

number and e-mail address: Sixth Floor,

Crystal Station #1, 2800 Jefferson Davis

Highway, Arlington, VA 22202, (703)

308–8783, email:jamerson.hoyt@epamail.epa.gov.

SUPPLEMENTARY INFORMATION: In the

Federal Register of January 8, 1997 (62

FR 1114)(FRL–5582–6), EPA issued a

notice pursuant to section 408 of the

Federal Food, Drug, and Cosmetic Act

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

the filing of amendments to pesticide

petitions (PP) for tolerances by the

Interregional Research Project No. 4 (IR4), New Jersey Agricultural Experiment

Station, P.O. Box 231, Rutgers

University, New Brunswick, NJ 08903.

This notice included a summary of the

petitions prepared by BASF

Corporation, the registrant. There were

no comments received in response to

the notice of filing. The amended

petitions requested that 40 CFR 180.412

be amended by extending the effective

dates to expire on December 31, 1998,

for the time-limited tolerances

established for combined residues of the

herbicide 2-[1-(ethoxyimino)butyl]-5-[2-

(ethylthio)propyl]-3-hydroxy-2-

cyclohexen-1-one) and its metabolites

containing the 2-cyclohexen-1-one

moiety (calculated as the herbicide) in

or on asparagus at 4.0 parts per million

(ppm), carrot at 1.0 ppm, cranberry and

endive at 2.0 ppm, and peppermint and

spearmint at 30.0 ppm. Registration for

use of sethoxydim on endive is limited

to Florida based on the geographical

representation of the residue data

submitted. Additional residue data will

be required to expand the area of usage.

Persons seeking geographically broader

registration should contact the Agency’s

Registration Division at the address

provided above.

These tolerances were established as

time-limited tolerances since an

acceptable carcinogenicity study is

needed in one rodent species. A repeat

chronic feeding/carcinogenicity study in

rats was submitted to EPA in November

of 1995 and is awaiting review. The

Agency will reassess sethoxydim

tolerances based on the outcome of the

rat chronic feeding/carcinogenicity

study and, if appropriate, will establish

permanent tolerances for asparagus,

carrot, cranberry, endive, peppermint

and spearmint.

I. Risk Assessment and Statutory

Findings

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, 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....’’

A. Method of Determining Risks

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. 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 percent of

the crop is treated by pesticides that

have established tolerances. If the

TMRC exceeds the Reference Dose (RfD)

or poses a lifetime cancer risk that is

greater than approximately one in a

million, EPA attempts to derive a more

accurate exposure estimate for the

pesticide by evaluating additional types

of information (anticipated residue data

and/or percent of crop treated data)

which show, generally, that pesticide

residues in most foods when they are

eaten are well below established

tolerances and that the total acreages for

all crops with established tolerances are

seldom treated with the pesticide.

The RfD is assumed to be the

exposure at or below which daily

aggregate exposure over a lifetime will

not pose an appreciable risk to human

health. To assure the adequacy of the

RfD, the Agency uses an uncertainty

factor in deriving it. The factor is

usually 100, based on the assumption

that certain segments of the human

population could be as much as 100

times more sensitive than the species

represented by the toxicology data. The

aggregate daily exposure to a pesticide

residue at or below the RfD (expressed

as l00 percent of the RfD) is generally

considered acceptable by EPA.

If the pesticide is determined to be a

human carcinogen, the toxicological

end-point must be determined based on

the nature of the carcinogenic response

and a knowledge of its mode of action.

The Agency uses a weight of evidence

approach in classifying the potential of

the pesticide as a human carcinogen.

In addition to assessing long-term,

chronic exposure to pesticide residues

in food, the Agency also evaluates

single-day or single event, acute

exposure. Acute dietary exposure to

residues of a pesticide in a food

commodity is estimated by multiplying

individual, single-day consumption

estimates of that food by the tolerance

level or the anticipated pesticide

residue level. Each individual’s daily

exposure to a pesticide is the sum of the
Federal Register / Vol. 62, No. 70 / Friday, April 11, 1997 / Rules and Regulations 17737

food commodities that individual

consumed on that given day multiplied

by the residue assumed to be present on

each food commodity consumed. Using

this method, a distribution of possible

daily exposures for a given population

is established.

From this distribution, an upper end

estimate of exposure is chosen and

compared to the most sensitive noobserved-effect level (NOEL) from

studies relating to the toxicological

effect of acute concern (usually

developmental toxicity or neurotoxicity)

to derive a Margin of Exposure (MOE).

The MOE is a measure of the level of

safety that exists between the estimated

exposure to a highly exposed individual

and the level below which effects were

observed in the available toxicological

studies.

B. Toxicological Profile

1. A 1–year feeding study with dogs

fed diets containing 0, 8.86/9.41, 17.5/

19.9, and 110/129 milligrams per

kilogram per day (mg/kg/day) (males/

females) with a NOEL of 8.86/9.41 mg/

kg/day (males/females) based on

equivocal anemia in male dogs at the

17.5-mg/kg/day dose level.

2. A 2–year chronic feeding/

carcinogenicity study with mice fed

diets containing 0, 40, 120, 360, and

1,080 ppm (equivalent to 0, 6, 18, 54,

and 162 mg/kg/day) with a systemic

NOEL of 120 ppm (18 mg/kg/day) based

on non-neoplastic liver lesions in male

mice at the 360 ppm (54 mg/kg/day)

dose level. There were no carcinogenic

effects observed under the conditions of

the study. The maximum tolerated dose

(MTD) was not achieved in female mice.

3. A 2–year chronic feeding/

carcinogenic study with rats fed diets

containing 0, 2, 6, and 18 mg/kg/day

with a systemic NOEL greater than or

equal to 18 mg/kg/day (highest dose

tested). There were no carcinogenic

effects observed under the conditions of

the study. This study was reviewed

under current guidelines and was found

to be unacceptable because the doses

used were insufficient to induce a toxic

response and an MTD was not achieved.

4. A second chronic feeding/

carcinogenic study with rats fed diets

containing 0, 360, and 1,080 ppm

(equivalent to 18.2/23.0, and 55.9/71.8

mg/kg/day (males/females). The dose

levels were too low to elicit a toxic

response in the test animals and failed

to achieve an MTD or define a lowest

effect level (LEL). Slight decreases in

body weight in rats at the 1,080-ppm

dose level, although not biologically

significant, support a free-standing noobserved-adverse-effect-level (NOAEL)

of 1,080 ppm (55.9/71.8 mg/kg/day

(males/females)). There were no

carcinogenic effects observed under the

conditions of the study.

5. A developmental toxicity study in

rats fed dosages of 0, 50, 180, 650, and

1,000 mg/kg/day with a maternal

NOAEL of 180 mg/kg/day and a

maternal LEL of 650 mg/kg/day

(irregular gait, decreased activity,

excessive salivation, and anogenital

staining); and a developmental NOAEL

of 180 mg/kg/day and a developmental

LEL of 650 mg/kg/day (21 to 22 percent

decrease in fetal weights, filamentous

tail, and lack of tail due to the absence

of sacral and/or caudal vertebrae, and

delayed ossification in the hyoids,

vertebral centrum and/or transverse

processes, sternebrae and/or

metatarsals, and pubes).

6. A developmental toxicity study in

rabbits fed doses of 0, 80, 160, 320, and

400 mg/kg/day with a maternal NOEL of

320 mg/kg/day and a maternal lowest

observed effect level (LOEL) of 400 mg/

kg/day (37 percent reduction in body

weight gain without significant

differences in group mean body weights

and decreased food consumption during

dosing); and a developmental NOEL

greater than 400 mg/kg/day (highest

dose tested).

7. A 2–generation reproduction study

with rats fed diets containing 0, 150,

600, and 3,000 ppm (approximately 0,

7.5, 30, and 150 mg/kg/day) with no

reproductive effects observed under the

conditions of the study.

8. Mutagenicity studies including:

Ames assays were negative for gene

mutation in Salmonella typhimurium

strains TA98, TA100, TA1535, and

TA1537, with and without metabolic

activity; a Chinese hamster bone

marrow cytogenetic assay was negative

for structural chromosomal aberrations

at doses up to 5,000 mg/kg in Chinese

hamster bone marrow cells in vivo; and

recombinant assays and forward

mutations tests in Bacillus subtilis,

Escherichia coli, and S. typhimurium

were all negative for genotoxic effects at

concentrations of greater than or equal

to 100 percent.

9. In a rat metabolism study, excretion

was extremely rapid and tissue

accumulation was negligible.

C. Toxicological Endpoints

1. Dietary— i. Chronic risk. The RfD

for sethoxydim is calculated at 0.09

milligrams per kilogram of body weight

per day (mg/kg/ bwt/day. The RfD is

based on a NOEL of 8.86 mg/kg/day

from a 1–year feeding study in dogs and

an uncertainty factor of 100. This study

demonstrated equivocal anemia in male

dogs at the LOEL of 17.5 mg/kg/day.

ii. Acute risk. EPA has determined

that an NOEL of 180 mg/kg/day from a

developmental toxicity study in rats

should be used to assess acute dietary

risk. Decreased fetal weights,

filamentous tail, lack of tail, and

delayed ossification were observed at

the LOEL of 650 mg/kg/day. The

population of concern for this risk

assessment are females 13+ years old.

iii. Cancer risk. EPA has not fully

determined the carcinogenic potential of

sethoxydim. No positive tumor findings

have been reported at this time in the

evaluations of rat or mouse

carcinogenicity studies. A repeat

carcinogenicity study in rats was

submitted by the registrant and is under

evaluation by EPA. There was no

reported carcinogenicity in the repeat

rat study.

2. Non-dietary. i. Short- and

intermediate-term risk. A risk

assessment is not needed since no

effects were observed in a 21–day

dermal toxicity study in rabbits at the

highest dose tested (1,000 mg/kg/day) or

in a developmental toxicity study in

rabbits at the highest dose tested (400

mg/kg/day).

ii. Chronic risk. Chronic risk estimates

are not required since non-dietary

(occupational/residential) exposure will

not be chronic.

D. Aggregate Exposures and Risks

1. From food. Food exposure to

sethoxydim will be from ingestion of

raw and processed agricultural

commodities, as listed in 40 CFR

180.412 and 185.2800. The existing

sethoxydim tolerances (published,

including the current time-limited

tolerances) result in a TMRC that is

equivalent to the following percentages

of the RfD:

U.S Population 36%

Non-Nursing Infants (<1 year old) 61%

Children (1 to 6 years old) 72%

The chronic dietary risk assessment

used conservative assumptions resulting

in risk estimates as high as 72% of the

reference dose. Actual risks using more

realistic assumptions would likely

result in significantly lower risk

estimates.

The acute dietary risk assessment

resulted in a MOE of 1,200 for females

(13+ years old), the population of

concern. The assumptions in this

assessment were: (1) All tolerance level

residues, (2) 100% crop treated, (3) no

mixing of commodities, and (4) all foods

consumed in a day by a person had

tolerance level residues. These
17738 Federal Register / Vol. 62, No. 70 / Friday, April 11, 1997 / Rules and Regulations

assumptions are extremely conservative;

risk assessment using more realistic

assumptions would result in an

estimated MOE significantly greater

than 1,200.

2. From drinking water. There is

presently no established Maximum

Concentration Level (MCL) for residues

of sethoxydim in drinking water, and no

health advisory levels for sethoxydim in

drinking water have been established.

Available monitoring studies, however,

indicate that sethoxydim residues may

migrate to ground water and surface

water. In addition, the available data are

inadequate to determine whether

residues of the degradates of

sethoxydim are likely to occur in water.

Therefore, assessments of the risks

posed to human health from exposure to

potential sethoxydim residues in

drinking water was conducted. The data used to estimate exposure in

water wells are from one study

conducted in Missouri involving 40

rural domestic drinking water wells and

25 public supply drinking water wells.

All of the available monitoring data

show nondetectable residues of

sethoxydim. Therefore, to estimate

sethoxydim exposure for the purposes

of exposure and risk assessment, a value

equal to one-half of the limit of

detection for the analytical methods was

used to determine sethoxydim residues

in the drinking water samples. Samples

from the rural domestic drinking water

wells and the public supply drinking

water wells were analyzed with

different analytical methods with

different limits of detection (0.2 parts

per billion (ppb) and 2 ppb,

respectively). This risk assessment

assumes exposure to be at 1 ppb based

on one-half of the higher limit of

detection (2 ppb). Exposure and risk

was also estimated based on the highest

sethoxydim residues (42 ppb) detected

in ground water. Exposures and risks to residues of

sethoxydim in drinking water were

calculated using the following formulas:

Adults (male): Exposure = (chemical

concentration in micrograms (μg)/liter (L) in

consumed water) × (l0-3 mg/micrograms (μg))

divided by (70 kg body weight) × (2 L water

consumed/day).

Children (1 to 6 years): Exposure =

(chemical concentration in μg/L in consumed

water) × (l0-3 mg/μg)) divided by (10 kg body

weight) × (1 L water consumed/day).

i. Chronic exposures and risks from

drinking water. a. Adult (male) exposure

(based on estimated residues in public

water wells) = (1μg/L) × (10-3 mg/μg)

divided by (70 kg body weight) × (2 L/

day) = 2.85 × 10-5 mg/kg/day, which

accounts for < 1% of the RfD.

b. Adult (male) exposure (based on

highest concentration detected in

ground water) = (42 μg/L) × (10-3 mg/μg)

divided by (70 kg body weight) × (2 L/

day) = 1.2 × 10-3 mg/kg/day, which

accounts for 1% of the RfD.

c. Children (1 to 6 years old) exposure

(based on estimated residues in public

water wells) = (1 μg)/L) × (10-3 mg/μg)

divided by (10 kg body weight) × (1 L/

day) = 1 × 10-4 mg/kg/day, which

accounts for < 1% of the RfD.

d. Children (1 to 6 years old) exposure

(based on highest concentration

detected in ground water) = (42 μg)/L)

× (10-3 mg/μg) divided by (10 kg body

weight) × (1 L/day) = 4.2 × 10-3 mg/kg/

day, which accounts for 5% of the RfD.

ii. Acute risk from drinking water. a.

Acute risk from residues of sethoxydim

in drinking water were calculated as

follows: Exposure = (chemical

concentration in μg)/L in consumed

water) × (10-3 mg/μg) divided by (kg

body weight) × (liters (L) of water

consumed/day). b. Adult (female) exposure (based on

highest concentration of sethoxydim

detected in ground water) = (42 μg)/L)

× (10-3 mg/μg) divided by (60 kg body

weight) × (2 L/day) = 1.4 × 10-3 μg)/kg/

day. c. Children (1 to 6 years old) exposure

(based on highest concentration of

sethoxydim detected in ground water) =

(42 μg)/L) × (10-3 mg/μg) divided by 10

kg body weight) × (1 L/day) = 4.2 × 10-3. d. Margins of Exposure were

calculated based on the above exposure

estimates as follows:

(i) For female adults consuming water

containing 42 μg/L of sethoxydim the

MOE is equal to 180/1.4 × 10-3 =

130,000.

(ii) For children (1 to 6 years old)

consuming water containing 42 μg)/L of

sethoxydim the MOE is equal to 180/1.4

× 10-3 = 43,000.

3. From non-dietary (residential)

exposure. Sethoxydim is currently

registered for use by homeowners on the

following residential use sites:

vegetables, fruits, flowers, shrubs, trees,

and bedding plants. However, this risk

assessment is not required.

4. Cumulative exposure to substances

with common mechanism of toxicity.

Section 408(b)(2)(D)(v) requires that,

when considering whether to establish,

modify, or revoke a tolerance, the

Agency consider ‘‘available

information’’ concerning the cumulative

effects of a particular pesticide’s

residues and ‘‘other substances that

have a common mechanism of toxicity.’’

The Agency believes that ‘‘available

information’’ in this context might

include not only toxicity, chemistry,

and exposure data, but also scientific

policies and methodologies for

understanding common mechanisms of

toxicity and conducting cumulative risk

assessments. For most pesticides,

although the Agency has some

information in its files that may turn out

to be helpful in eventually determining

whether a pesticide shares a common

mechanism of toxicity with any other

substances, EPA does not at this time

have the methodologies to resolve the

complex scientific issues concerning

common mechanism of toxicity in a

meaningful way. EPA has begun a pilot

process to study this issue further

through the examination of particular

classes of pesticides. The Agency hopes

that the results of this pilot process will

increase the Agency’s scientific

understanding of this question such that

EPA will be able to develop and apply

scientific principles for better

determining which chemicals have a

common mechanism of toxicity and

evaluating the cumulative effects of

such chemicals. The Agency anticipates,

however, that even as its understanding

of the science of common mechanisms

increases, decisions on specific classes

of chemicals will be heavily dependent

on chemical specific data, much of

which may not be presently available.

Although at present the Agency does

not know how to apply the information

in its files concerning common

mechanism issues to most risk

assessments, there are pesticides as to

which the common mechanism issues

can be resolved. These pesticides

include pesticides that are

toxicologically dissimilar to existing

chemical substances (in which case the

Agency can conclude that it is unlikely

that a pesticide shares a common

mechanism of activity with other

substances) and pesticides that produce

a common toxic metabolite (in which

case common mechanism of activity

will be assumed).

EPA does not have, at this time,

available data to determine whether

sethoxydim 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,

sethoxydim 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 sethoxydim has a common

mechanism of toxicity with other

subtances.

E. Determination of Safety for Infants

and Children

FFDCA section 408 provides that EPA

shall apply an additional tenfold MOE

(safety) for infants and children in the
Federal Register / Vol. 62, No. 70 / Friday, April 11, 1997 / Rules and Regulations 17739

case of threshold effects to account for

pre-and post-natal toxicity and the

completeness of the database unless

EPA determines that a different MOE

(safety) will be safe for infants and

children. Margins of exposure (safety)

are often referred to as uncertainty

(safety) factors. EPA believes that

reliable data support using the standard

MOE (usually 100x for combined interand intra-species variability)) and not

the additional tenfold MOE when EPA

has a complete data base under existing

guidelines and when the severity of the

effect in infants or children or the

potency or unusual toxic properties of a

compound do not raise concerns

regarding the adequacy of the standard

MOE.

The data base for sethoxydim realtive

to pre- and post-natal toxicity is

complete and is summarized as follows:

1. Developmental toxicity studies. In

the rat developmental toxicity study the

maternal (systemic) NOEL is established

at 180 mg/kg/day, based on irregular

gait, decreased activity, excessive

salivation and anogenital staining at 650

mg/kg/day. The developmental (pup)

NOEL is 180 mg/kg/day, based on

decreased fetal weights, filamentous

tail, lack of tail, and delayed-ossification

at 650 mg/kg/day.

In the rabbit developmental toxicity

study the maternal (systemic) NOEL is

established at 320 mg/kg/day, based on

a 37% reduction in body weight gain

without significant differences in group

mean body weights and food

consumption at 400 mg/kg/day. The

developmental (pup) NOEL is ≥400 mg/

kg/day (highest dose tested).

2. Reproduction studies. In a 2-

generation reproduction study in the rat

the maternal/reproductive NOEL is

approximately 150 mg/kg/day, the

highest dose tested. This study did not

fully meet the requirements of achieving

toxicity as defined by the Pesticide

Assessment Guidelines ( OPPTS-870);

however, this study is considered usable

for regulatory purposes and a

freestanding NOEL is established at

approximately 150 mg/kg/day (LOEL

not established). There were no

indications of toxicity, dose-related

effects on fertility, or difficult deliveries

in either parental generation.

Conclusions. The toxicological

database for evaluating pre- and

postnatal toxicity for sethoxydim is

complete. Available data indicate that

no developmental toxicity was observed

in the rabbit study at the highest dose

tested (400 mg/kg/day). Maternal

toxicity was observed in the rabbit at the

highest dose tested and consisted of

significant reductions in body weight

gain and food consumption. In the rat

developmental study developmental

toxicity was observed in the presence of

significant maternal toxicity at a high

dose level (650 mg/kg/day). There was

no parental or reproductive toxicity

observed in a multigeneration

reproduction study at doses up to 150

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

data taken together suggest minimal

concern for developmental or

reproductive toxicity and do not

indicate any increased pre- or postnatal

sensitivity; and no additional

uncertainty factor for increased

sensitivity in infants and children is

appropriate. Therefore, EPA concludes

that reliable data support using a

hundredfold uncertainty factor and that

uncertainty factor will protect the safety

of infants and children without an

additional tenfold uncertainty factor.

Based on very conservative exposure

assumptions, EPA concludes that

aggregate exposure to children and

infants will not exceed the RfD. EPA

concludes that there is a reasonable

certainty that no harm will result to

infants and children from aggregate

exposure.

F. Other Considerations

1. Endocrine effects. An evaluation of

the potential effects on the endocrine

systems of mammals has not been

determined; however, no evidence of

such effects were reported in the

chronic toxicology studies described

above. There were no observed

pathology of the endocrine organs in

these studies. There is no evidence at

this time that sethoxydim causes

endocrine effects.

2. Metabolism in plants and animals.

The metabolism of sethoxydim in plants

and animals is adequately understood

for the purposes of these tolerances. The

residues of concern in plants and

animals are sethoxydim and its

metabolites containing the 2-

cyclohexen-l-one moiety calculated as

sethoxydim, as specified in 40 CFR

180.412.

3. Secondary residues. Carrot culls are

the only animal feed items associated

with these uses. Secondary residues in

animal commodities are not expected to

exceed existing tolerances as a result of

this use.

4. Analytical method. There is a

practical analytical method for detecting

and measuring levels of sethoxydim and

its metabolites in or on food with a limit

of detection that allows monitoring of

food with residues at or above the levels

set in this tolerance. Method 30G, is

available in PAM, Vol II to enforce the

tolerance expression. Method 30G is a

capillary gas chromatography method

which uses flame photometric detection

in the sulfur mode and determines total

residues of sethoxydim and its

metabolites containing the 2-

cyclohexen-l-one moiety.

5. International tolerances. There are

no Codex, Canadian, or Mexican

Maximum Residue Levels or tolerances

established for sethoxydim in/on

asparagus, endive, carrots, cranberry, or

mint.

II. Summary of Findings

Both the chronic and acute dietary

risk assessments are conservative and

represent overestimates of risk because

they assume tolerance level residues

and 100% crop treated for all

commodities having sethoxydim

tolerances. Refinement of dietary

exposure estimates using percent crop

treated data and/or anticipated residue

data would result in significantly lower

dietary exposure estimates. Aggregate

chronic risks are estimated at 37% of

the RfD (36% for food and 1% for water)

for the general population, and 77% of

the RfD (72% for food and 5% for water

for children (1 to 6 years old)). For acute

dietary risks, the calculated MOE’s for

the population subgroup of concern

(females 13+ years old) is 1,200 from

residues of sethoxydim in food and >

130,000 for residues in drinking water.

The aggregate MOE is also 1,200.

Based on the information cited above,

the Agency has determined that the

establishment of the time-limited

tolerances by amending 40 CFR 180.412

will be safe; therefore, the time-limited

tolerances are established as set forth

below.

In addition to the time-limited

tolerances being amended, since for

purposes of establishing tolerances

FQPA has eliminated all distinctions

between raw and processed food, EPA is

combining the tolerances that now

appear in §§ 185.2800 and 186.2800

with the tolerances in § 180.412 and is

eliminating §§ 185.2800 and 186.2800.

III. 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 (1)(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 governs 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
17740 Federal Register / Vol. 62, No. 70 / Friday, April 11, 1997 / Rules and Regulations

appropriate adjustments to reflect the

new law.

Any person may, by June 10, 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 issue(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). A

request for a hearing will be granted if

the Administrator determines 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

issue(s) 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.

IV. Public Docket

A record has been established for this

rulemaking under docket number [OPP–

300467; PP 0E3909, 2E4052, 2E4065,

2E4092, and 3E4162]. A public version

of this record, 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 Response and Program

Resources Branch, Field Operations

Division (7506C), Office of Pesticide

Programs, Environmental Protection

Agency, Crystal Mall #2, 1921 Jefferson

Davis Highway, Arlington, VA.

The official record for this

rulemaking, as well as the public

version, as described above, is kept in

paper form. Accordingly, in the event

there are objections and hearing

requests, 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. The official rulemaking record is

the paper record maintained at the

address in ‘‘ADDRESSES’’ at the

beginning of this document.

V. Regulatory Assessment

Requirements

Under Executive Order 12866 (58 FR

51735, Oct. 4, 1993), this action is not

a ‘‘significant regulatory action’’ and

since this action does not impose any

information collection requirements

subject to approval under the Paperwork

Reduction Act, 44 U.S.C. 3501 et seq.,

it is not subject to review by the Office

of Management and Budget. In addition,

this action does not impose any

enforceable duty, or contain any

‘‘unfunded mandates’’ as described in

Title II of the Unfunded Mandates

Reform Act of 1995 (Pub. L. 104–4), or

require prior consultation as specified

by Executive Order 12875 (58 FR 58093,

October 28, l993), or special

considerations as required by Executive

Order 12898 (59 FR 7629, February 16,

l994).

Because tolerances established on the

basis of a petition under section 408(d)

of FFDCA do not require issuance of a

proposed rule, the regulatory flexibility

analysis requirements of the Regulatory

Flexibility Act (RFA), 5 U.S.C. 604(a),

do not apply. Prior to the recent

amendment of the FFDCA, EPA had

treated such rulemakings as subject to

the RFA; however, the amendments to

the FFDCA clarify that no proposal is

required for such rulemakings and

hence that the RFA is inapplicable.

Nonetheless, the Agency has previously

assessed whether establishing tolerances

or exemptions from tolerance, raising

tolerance levels, or expanding

exemptions adversely impact small

entities and concluded, as a generic

matter, that there is no adverse impact.

(46 FR 24950) (May 4, 1981).

Pursuant to 5 U.S.C. 801(a)(1)(A), EPA

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 the rule in

today’s Federal Register. This rule is

not a major rule as defined by 5 U.S.C.

804(2).

List of Subjects

40 CFR Part 180

Environmental protection,

Administrative practice and procedure,

Agricultural commodities, Pesticides

and pests, Reporting and recordkeeping

requirements.

40 CFR Part 185

Environmental protection, Food

additives, Pesticides and pests.

40 CFR Part 186

Environmental protection, Animal

feeds, Pesticides and pests.

Dated: April 4, 1997.

Penelope A. Fenner-Crisp,

Acting Director, Office of Pesticide Programs.

Therefore, 40 CFR chapter I is

amended as follows:

PART 180— [AMENDED]

1. In part 180:

a. The authority citation for part 180

continues to read as follows:

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

b. Section 180.412 is amended as

follows:

i. By revising the section heading to

read as set forth below.

ii. By revising paragraph (a).

iii. In paragraph (b) by removing the

text and by adding the heading ‘‘Section

18 emergency exemptions.’’, and

reserving it.

iv. By revising paragraph (c).

v. By removing the text of paragraph

(d), adding a heading entitled ‘‘Indirect

and inadvertent residues.’’ and

reserving it.

§ 180.412 Sethoxydim; tolerances for

residues.

(a) General. Tolerances are

established for combined residues of the

herbicide 2-[1-(ethoxyimino)butyl]-5-[2-

(ethylthio)propyl]-3-hydroxy-2-

cyclohexen-1-one (CAS Reg. No. 74051–

80–2) and its metabolites containing the

2-cyclohexen-1-one moiety (calculated

as the herbicide) in or on the following

commodities:
Federal Register / Vol. 62, No. 70 / Friday, April 11, 1997 / Rules and Regulations 17741

Commodity Parts per

million Expiration/Revocation Date

Alfalfa, forage ..................................................................................................................................... 40.0 None

Alfalfa, hay ......................................................................................................................................... 40.0 None

Almond hulls ....................................................................................................................................... 2.0 None

Apple pomace, wet and dry ............................................................................................................... 0.8 None

Asparagus .......................................................................................................................................... 4.0 December 31, 1998

Beans, dry .......................................................................................................................................... 20.0 None

Beans, forage ..................................................................................................................................... 10.0 None

Beans, hay ......................................................................................................................................... 50.0 None

Beans, succulent ................................................................................................................................ 5.0 None

Blueberries ......................................................................................................................................... 4.0 None

Brassica leafy vegetables .................................................................................................................. 5.0 None

Bulb vegetables .................................................................................................................................. 1.0 None

Canola/rapeseed, meal ...................................................................................................................... 40.0 None

Canola/rapeseed ................................................................................................................................ 35.0 None

Carrot ................................................................................................................................................. 1.0 December 31, 1998

Cattle, fat ............................................................................................................................................ 0.2 None

Cattle, mbyp ....................................................................................................................................... 0.2 None

Cattle, meat ........................................................................................................................................ 0.2 None

Celery ................................................................................................................................................. 1.0 None

Citrus fruits ......................................................................................................................................... 0.5 None

Citrus molasses .................................................................................................................................. 1.5 None

Citrus pulp, dried ................................................................................................................................ 1.5 None

Clover, forage ..................................................................................................................................... 35.0 None

Clover, hay ......................................................................................................................................... 50.0 None

Cottonseed soapstock ........................................................................................................................ 15 None

Corn, field, grain ................................................................................................................................. 0.5 None

Corn fodder ........................................................................................................................................ 2.5 None

Corn forage ........................................................................................................................................ 2.0 None

Corn, sweet (K+CWHR) ..................................................................................................................... 0.2 None

Cranberry ........................................................................................................................................... 2.0 December 31, 1998

Cottonseed ......................................................................................................................................... 5.0 None

Cucurbits vegetables .......................................................................................................................... 4.0 None

Eggs ................................................................................................................................................... 2.0 None

Flaxseed ............................................................................................................................................. 5.0 None

Flaxseed meal .................................................................................................................................... 7 None

Flax straw ........................................................................................................................................... 2.0 None

Fruiting vegetables ............................................................................................................................. 4.0 None

Goats, fat ............................................................................................................................................ 0.2 None

Goats, mbyp ....................................................................................................................................... 0.2 None

Goats, meat ........................................................................................................................................ 0.2 None

Grape pomace, wet and dry .............................................................................................................. 6.0 None

Grapes ................................................................................................................................................ 0.2 None

Hogs, fat ............................................................................................................................................. 0.2 None

Hogs, mbyp ........................................................................................................................................ 0.2 None

Hogs, meat ......................................................................................................................................... 0.2 None

Horses, fat .......................................................................................................................................... 0.2 None

Horses, mbyp ..................................................................................................................................... 0.2 None

Horses, meat ...................................................................................................................................... 0.2 None

Lentils ................................................................................................................................................. 30.0 None

Lettuce, head ..................................................................................................................................... 1.0 None

Lettuce, leaf ........................................................................................................................................ 2.0 None

Milk ..................................................................................................................................................... 0.05 (N) None

Peanuts .............................................................................................................................................. 25.0 None

Peanuts, hull ...................................................................................................................................... 5.0 None

Peanut soapstock ............................................................................................................................... 75.0 None

Peas, dry ............................................................................................................................................ 40.0 None

Peas, forage ....................................................................................................................................... 20.0 None

Peas, hay ........................................................................................................................................... 40.0 None

Peas, succulent .................................................................................................................................. 10.0 None

Peppermint, tops (stems and leaves) ................................................................................................ 30.0 December 31, 1998

Pome fruits ......................................................................................................................................... 0.2 None

Potatoes ............................................................................................................................................. 4.0 None

Potato flakes ...................................................................................................................................... 8.0 None

Potato granules .................................................................................................................................. 8.0 None

Potato waste, processed (wet and dry) ............................................................................................. 8.0 None

Poultry, fat .......................................................................................................................................... 0.2 None

Poultry, mbyp ..................................................................................................................................... 2.0 None

Poultry, meat ...................................................................................................................................... 0.2 None

Raisins ................................................................................................................................................ 1.0 None

Raisin waste ....................................................................................................................................... 1.0 None

Raspberries ........................................................................................................................................ 5.0 None
17742 Federal Register / Vol. 62, No. 70 / Friday, April 11, 1997 / Rules and Regulations

Commodity Parts per

million Expiration/Revocation Date

Sheep, fat ........................................................................................................................................... 0.2 None

Sheep, mbyp ...................................................................................................................................... 0.2 None

Sheep, meat ....................................................................................................................................... 0.2 None

Soybean, hay ..................................................................................................................................... 10.0 None

Soybeans ........................................................................................................................................... 10.0 None

Spearmint, tops (stems and leaves) .................................................................................................. 30.0 December 31, 1998

Spinach .............................................................................................................................................. 4.0 None

Strawberries ....................................................................................................................................... 10.0 None

Sugar beet molasses ......................................................................................................................... 10.0 None

Sugar beet, roots ............................................................................................................................... 1.0 None

Sugar beet, tops ................................................................................................................................. 3.0 None

Sunflower meal .................................................................................................................................. 20.0 None

Sunflower seeds ................................................................................................................................. 7.0 None

Sweet potato ...................................................................................................................................... 4.0 None

Tomato pomace, dried ....................................................................................................................... 12.0 None

Tomato products, concentrated ......................................................................................................... 24 None

Tree nuts ............................................................................................................................................ 0.2 None

(b) Section 18 emergency exemptions.

[Reserved]

(c) Tolerances with regional

registration. Tolerances with regional

registration, as defined in § 180.1(n), are

established for the combined residues of

the herbicide 2-[1-(ethoxyimino)butyl]-

5-[2-(ethylthio)propyl]-3-hydroxy-2-

cyclohexen-1-one) and its metabolites

containing the 2-cyclohexen-1-one

moiety (calculated as the herbicide) in

or on the following commodities:

Commodity Parts per

million Expiration/Revocation Date

Artichokes ........................................................................................................................................... 3.0 None

Endive ................................................................................................................................................ 2.0 December 31, 1998

Rhubarb .............................................................................................................................................. 0.3 None

(d) Indirect and inadvertent

residues.[Reserved]

PART 185—[AMENDED]

2. In part 185:

a. The authority citation for part 185

continues to read as follows:

Authority: 21 U.S.C. 346a and 348.

§ 185.2800 [Removed]

b. Section 185.2800 is removed.

PART 186—[AMENDED]

3. In part 186:

a. The authority citation for part 186

continues to read as follows:

Authority: 21 U.S.C.342, 348, and 701.

§ 186.2800 [Removed]

b. Section 186.2800 is removed.

[FR Doc. 97–9374 Filed 4–10–97; 8:45 am]

BILLING CODE 6560–50–F

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Parts 180, 185, and 186

[OPP–300470; FRL–5598–2]

RIN 2070–AC78

Norflurazon; Pesticide Tolerance for

Emergency Exemptions

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Final rule.

SUMMARY: This regulation establishes

time-limited tolerances for residues of

the herbicide norflurazon in or on the

raw agricultural commodities

bermudagrass hay and forage in

connection with EPA’s granting of

emergency exemptions under section 18

of the Federal Insecticide, Fungicide,

and Rodenticide Act authorizing use of

norflurazon on bermudagrass in the

states of Alabama, Georgia, Louisiana,

Mississippi, and Texas. This regulation

establishes maximum permissible levels

for residues of norflurazon in these

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

Federal Food, Drug, and Cosmetic Act,

as amended by the Food Quality

Protection Act of 1996. The tolerances

will expire and be revoked by EPA on

November 30, 1998.

DATES: This regulation becomes

effective April 11, 1997. Objections and

requests for hearings must be received

by EPA on or before June 10, 1997.

ADDRESSES: Written objections and

hearing requests, identified by the

docket control number, [OPP–300470],

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 document control number, [OPP–

300470], must also be submitted to:

Public Response and Program Resources

Branch, Field Operations 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,