Federal Register / Vol. 62, No. 46 / Monday, March 10, 1997 / Rules and Regulations 10703

APPENDIX A: SUMMARY OF ACCEPTABLE DECISIONS, REFRIGERATION SECTOR—Continued

[Acceptable Decisions]

End-use Substitute Decision Comments

Foam Sector—Acceptable Decisions

HCFCs Rigid polyurethane and

polyisocyanurate laminated boardstock.

Saturated Light Hydrocarbons C3–C6.Acceptable ...................................................... Zero ODP and GWP but must adhere to

VOC regulations. Flammable.

HCFCs Rigid polyurethane appliance.HFC–134a .................. Acceptable ...................................................... Non-flammable and low toxicity but may contribute to global warming.

Saturated Light Hydrocarbons C3–C6Acceptable ................. Zero ODP and GWP but must adhere to

VOC regulations. Flammable..

Carbon Dioxide .......... Acceptable ...................................................... High thermal conductivity.

[FR Doc. 97–5887 Filed 3–7–97; 8:45 am]

BILLING CODE 6560–50–P

40 CFR Part 180

[OPP–300459; FRL–5591–9]

RIN AB–78

Sulfentrazone; Establishment of

Tolerances

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Final rule.

SUMMARY: This document establishes

tolerances for residues of the herbicide

sulfentrazone (N-[2,4-dichloro-5-[4-

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

yl]phenyl]methanesulfonamide) and its

major metabolite 3-hydroxymethyl

sulfentrazone (N-[2,4-dichloro-5-[4-

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

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

yl]phenyl]methanesulfonamide), in or

on the raw agricultural commodity

soybean seed at 0.05 ppm and for

combined inadvertent residues of

sulfentrazone, and its metabolites, 3-

hydroxymethyl sulfentrazone and 3-

desmethyl sulfentrazone [N-[2,4-

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

dihydro-5-oxo-1H-1,2,4-triazol-lyl]phenyl]methanesulfonamide] in

cereal grains (excluding sweet corn)

forage at 0.2 ppm, straw at 0.6 ppm, hay

at 0.2 ppm, grain at 0.1 ppm, stover at

0.1 ppm, bran at 0.15 ppm and hulls at

0.30 ppm. FMC Corporation submitted a

petition to EPA under the Federal Food,

Drug and Cosmetic Act as amended by

the Food Quality Protection Act of l996

(Pub. L. 104-170) requesting the

tolerances.

EFFECTIVE DATE: This regulation

becomes effective March 10, 1997.

ADDRESSES: Written objections and

hearing requests, identified by the

docket control number, [PF–670/OPP–

300459], may 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 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 Hwy., 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 (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 PF–670/OPP–300459. 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: Joanne I. Miller, Product Manager

(PM) 23, Registration Division (7505C),

Environmental Protection Agency, 401

M St., SW., Washington, DC 20460.

Office location and telephone number:

Rm. 237, CM #2, 1921 Jefferson Davis

Hwy., Arlington, VA 22202, (703)-305-

6224; e-mail:

miller.joanne@epamail.epa.gov.

SUPPLEMENTARY INFORMATION: In the

Federal Register of November 6, 1996

(60 FR 57420) (FRL–5571–4), EPA

issued a notice pursuant to section

408(d) of the Federal Food, Drug, and

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

346a(d), announcing the filing of a

pesticide tolerance petition by FMC

Corporation, 1735 Market Street,

Philadelphia, PA 19103. The petition

requested to amend 40 CFR part 180 by

establishing a tolerance for residues of

the herbicide sulfentrazone (N-[2,4-

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

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

triazol-1-yl] phenyl]methanesulfonamide) in or on raw agricultural

commodity soybean seed at 0.05 ppm

and rotational crop tolerances in cereal

grains from 0.1 to 0.5 ppm. There were

no comments received in response to

the notice of filing.

The data submitted in the petition

and other relevant material have been

evaluated. The toxicology data listed

below were considered in support of

these tolerances.

I. Toxicological Profile

1. A battery of acute toxicity studies

placed technical sulfentrazone in

Toxicity Categories III and IV. No

evidence of sensitization was observed

following dermal application in guinea

pigs.

2. A 90–day subchronic toxicity study

was conducted in rats, with dietary

intake levels of 0, 3.3, 6.7, 19.9, 65.8,

199.3, or 534.9 mg/kg/day for males and

0, 4, 7.7, 23.1, 78.1, 230.5, or 404.3

milligrams/kilograms/day (mg/kg/day)

for females respectively. No Observed

Effect Levels (NOELs) of 19.9 mg/kg/day

in males and 23.1 mg/kg/day in females

were based on clinical anemia.

3. A 90–day subchronic feeding study

was conducted in mice by dietary admix
10704 Federal Register / Vol. 62, No. 46 / Monday, March 10, 1997 / Rules and Regulations

at doses of 0, 10.3, 17.8, 60.0, 108.4, or

194.4 mg/kg/day for males and 0, 13.9,

29.0, 79.8, 143.6, or 257.0 mg/kg/day for

females, respectively. NOELs of 60 mg/

kg/day (males) and 79.8 mg/kg/day

(females) were based on decreases in

body weights and/or gains; decreased

erythrocytes, hemoglobin and

hematocrit values; and splenic

microscopic pathology.

4. In a 90–day subchronic feeding

study in dogs administered by dietary

admix at doses of 0, 10, 28, or 57 mg/

kg/day for males and 0, 10, 28, or 73

mg/kg/day for females, a NOEL of 28

mg/kg/day was determined for both

males and females based on decreases in

hemoglobin and hematocrit, elevated

alkaline phosphatase levels, increased

liver weights and microscopic liver as

well as splenic changes.

5. A 12–month feeding study in dogs

was dosed at levels of 0.0, 9.9, 24.9, or

61.2 mg/kg/day for male dogs and 0.0,

10.4, 29.6, or 61.9 mg/kg/day for female

dogs in the control through high-dose

groups, respectively, with a NOEL of

24.9 mg/kg/day for males and 29.6 mg/

kg/day for females based on hematology

effects and microscopic liver changes.

6. An 18–month feeding/

carcinogenicity study in mice was

conducted with dietary intake of 0, 46.6,

93.9, 160.5, or 337.6 mg/kg/day for

males and 0, 58.0, 116.9, 198.0, or 407.1

mg/kg/day for females. A NOEL of 93.9

mg/kg/day in males and 116.9 mg/kg/

day in females was based on decreases

in hemoglobin and hematocrit. There

were no treatment-related increases in

tumors of any kind observed at any dose

level.

7. In a 24–month chronic feeding/

oncogenicity study in rats at dietary

doses of 0, 24.3, 40.0, 82.8, or 123.5 mg/

kg/day for males and 0, 20.0, 36.4, 67.0,

or 124.7 mg/kg/day for females, an

overall NOEL of 40.0 mg/kg/day in

males and 36.4 mg/kg/day in females

was based on hematology effects and

reduced body weights. There was no

evidence of an oncogenic response.

8. A prenatal oral developmental

toxicity study in the rat with dose levels

at 25.0 or 50.0 mg/kg/day established a

maternal NOEL of 25 mg/kg/day based

on decreased body weight gain,

increased spleen weight, and

microscopic changes in the spleen, and

a fetal NOEL of 10 mg/kg/day was based

on fetal death, reduced body weights,

and alterations in skeletal development

at higher doses.

9. A supplemental oral developmental

toxicity study conducted in rats at oral

dose levels of 25.0 and 50.0 mg/kg/day

to test for cardiac effects at the request

of the EPA, did not reveal any

significant effects on fetal cardiac

development. The results of this study

confirmed the maternal and fetal

findings of the previously-conducted

developmental study on sulfentrazone

in rats and did not alter the study

conclusions.

10. In a dermal developmental study

in the rat at doses of 0, 5, 25, 50, 100

and 250 mg/kg/day, a maternal

(systemic) No Observed Adverse Effect

Level (NOAEL) was established at 250

mg/kg/day. Significant treatment-related

increases in the fetal and litter

incidences of incompletely ossified

lumbar vertebral arches, hypoplastic or

wavy ribs, and incompletely ossified or

nonossified ischia or pubes occurred at

the high-dose (250 mg/kg/day). An

additional significant increase in the

high-dose fetal incidence of variations

in the sternebrae (incompletely ossified

or unossified) was not judged to be

treatment-related. At 250 mg/kg/day, the

mean numbers of thoracic vertebral and

rib ossification sites were significantly

decreased, a high-dose effect of

treatment with sulfentrazone consistent

with the significant treatment-related

hypoplasia observed in the skeletal

evaluation of the ribs. Therefore, the

developmental (fetal) Lowest Observed

Effect Level (LOEL) is 250 mg/kg/day

based on decreased fetal body weight;

increased incidences of fetal variations:

hypoplastic or wavy ribs, incompletely

ossified lumbar vertebral arches, and

incompletely ossified ischia or pubes;

and reduced number of thoracic

vertebral and rib ossification sites. The

developmental (fetal) NOEL is 100 mg/

kg/day.

11. A developmental toxicity study in

rabbits was conducted at gavage dose

levels of 0, 100, 250, or 375 mg/kg/day.

Treatment-related incidences of

decreased feces and hematuria were

noted at 250 mg/kg/day or greater. In

addition, at the 375 mg/kg/day dose

level, five rabbits aborted. Significant

reductions in mean body weight change

were observed for the dosing period (GD

7- 19) and for the study duration (GD 0-

29, both before and after adjustment for

gravid uterine weight) at the 250 and

375 mg/kg/day dose levels. Therefore,

the maternal (systemic) LOEL is 250 mg/

kg/day, based upon increased abortions,

clinical signs (hematuria and decreased

feces), and reduced body weight gain.

The maternal (systemic) NOEL is 100

mg/kg/day. Skeletal evaluation in

fetuses revealed dose- and treatmentrelated findings at the 375 mg/kg/day

dose level. These included significant

increases in both the fetal and litter

incidences of fused caudal vertebrae (a

malformation) and of partially fused

nasal bones (a variation). In addition, at

375 mg/kg/day, significant treatmentrelated reductions in ossification site

averages were observed for metacarpals

and both fore- and hindpaw phalanges.

Therefore, the developmental (fetal)

LOEL is 250 mg/kg/day, based upon

increased resorptions, decreased live

fetuses per litter, and decreased fetal

weight. The developmental (fetal) NOEL

is 100 mg/kg/day.

12. A two-generation reproduction

study in the rat at dietary levels of 14,

33, or 46 mg/kg/day in males and 16, 40,

or 56 mg/kg/day in females established

a NOEL for systemic and reproductive/

developmental parameters of 14 mg/kg/

day for males and 16 mg/kg/day for

females. The LOEL for systemic and

reproductive/development parameters

was 33 mg/kg/day for males and 40 mg/

kg/day for females. Systemic effects

were comprised of decreased body

weight gains, while reproductive/

developmental effect at the LOEL

included degeneration and/or atrophy

in the testes, with epididymal sperm

deficits, in the second (F1) generation

males. Male fertility in the F1

generation was reduced at higher doses;

litter size, pup survival, and pup body

weight for both generations were also

effected at higher doses.

13. A supplemental two-generation rat

reproduction study was conducted at

dietary intake levels of 50, 100, 200, or

500 ppm with a NOEL for reproductive

parameters of 200 ppm. This study

confirmed the reproductive/

developmental effects observed in the

first two-generation reproductive

toxicity study. It was the conclusion of

the RfD/Peer Review Committee that,

under the conditions of the studies

reviewed, sulfentrazone caused

developmental and reproductive

toxicity. The results of these studies

elicited a high level of concern by the

Committee, since the developmental

toxicity studies demonstrated embryo/

fetal toxicity at treatment levels that

were not maternally toxic, and

significant toxic effects were observed

primarily in the second generation

animals of the reproduction study.

Because these animals had been

exposed to sulfentrazone in utero, the

possibility that the observed

reproductive toxicity resulted from a

developmental and/or genotoxic

mechanism was suggested.

14. A reverse gene mutation assay

(salmonella typhimurium) yielded

negative results, both with and without

metabolic activation.

15. A mouse lymphoma forward gene

mutation assay yielded negative results

with equivocal results without

activation.
Federal Register / Vol. 62, No. 46 / Monday, March 10, 1997 / Rules and Regulations 10705

16. A mouse micronucleus assay test

was negative following intraperitoneal

injection of 340 mg/kg.

17. In an acute neurotoxicity study in

rats at gavage doses of 0, 250, 750, or

2,000 mg/kg, a NOEL of 250 mg/kg and

a LOEL of 750 mg/kg were based upon

increased incidences of clinical signs,

Functional Observation Battery (FOB)

findings, and decreased motor activity

which were reversed by day 14 postdose. There was no evidence of

neuropathology.

18. A 90–day subchronic

neurotoxicity study in the rat was

conducted at dietary levels of 30, 150,

or 265 mg/kg/day in males, and 37, 180,

or 292 mg/kg/day in females, with a

NOEL of 30 mg/kg/day in males and 37

mg/kg/day in females. The LOEL was

150 mg/kg/day for males and 180 mg/

kg/day for females based on increased

incidences of clinical signs, decreased

body weights, body weight gains, and

food consumption in females and

increased motor activity in females at

week 13. There were no

neurohistopathological effects on the

peripheral or central nervous system.

19. A metabolism study in rats

indicated that approximately 84 to

104% of the orally administered dose of

sulfentrazone was excreted in the urine,

and that the pooled urinary

radioactivity consisted almost entirely

of 3-hydroxymethyl sulfentrazone.

Pooled fecal radioactivity showed that

the major metabolite consisted of 3-

hydroxymethyl-sulfentrazone (1.26 to

2.55% of the administered dose). The

proposed metabolic pathway appeared

to be conversion of the parent

compound mainly to 3-hydroxymethylsulfentrazone (excreted in urine and

feces).

II. Aggregate Exposures

1. Food and feed uses. The primary

source for human exposure to

sulfentrazone will be from ingestion of

both raw and processed agricultural

commodities from soybeans. A DRES

chronic exposure analysis was

performed using tolerance level residues

and 100% crop treated information to

estimate the Theoretical Maximum

Residue Contribution (TMRC) for the

general population and 22 subgroups.

The chronic analysis showed that

exposure from the proposed new

tolerance, in/on soybeans, on cereal

grains (excluding sweet corn), on bran

of cereal grains, milk, eggs, and meat for

children 1 to 6 years old (the subgroup

with the highest exposure) would be

38.8% of the RfD. The exposure for the

general U.S. population would be 16.7%

of the RfD.

The analysis for sulfentrazone is a

worst case estimate of dietary exposure

with all residues at tolerance level and

100 percent of the commodities

assumed to be treated with

sulfentrazone. Even without

refinements, the chronic dietary risk

exposure to sulfentrazone appears to be

minimal for this petition.

2. Potable water. A ground water

exposure estimate for sulfentrazone is

based on findings from a voluntary

prospective ground water study

conducted in a sandy (worst case) site

in North Carolina. Although this single

ground water monitoring study was

incomplete, enough data were collected

to confirm that sulfentrazone leaches

substantially to ground water in areas

with sandy soils. Sulfentrazone was

found in ground water at concentrations

as high as 37 parts per billion (ppb) in

shallow wells and 19 ppb in deeper

wells. Residues in shallow ground water

were highly persistent and only slowly

dissipated, with little change in

concentrations over a 1-year period, at

which time sampling was terminated.

The use of 37 ppb in estimating dietary

exposure through ground water

represents the worst case. The worst

case is based on soil type (sandy) and

a limited population that would obtain

their drinking water from wells in this

type of soil. However, HED feels that

due to sulfentrazone’s mobility (Koc =

43; Kd = 0.2-0.8) and persistence (≈9

year half life), over time the worst case

values may be approached in more

typical ground water settings. Using 37

ppb, the dietary exposure from potable

water is 0.00105 mg/kg/day to adults

and 0.0037 mg/kg/day for children 1 to

6 years old.

3. Non-dietary uses. Since the petition

for use of sulfentrazone is limited to

commercial soybean production, no

non-dietary exposures are expected for

the general population.

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.’’

While 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 capability to resolve the

scientific issues concerning common

mechanism of toxicity in a meaningful

way. EPA is commencing 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 enable

the Agency to apply common

mechanism issues to its pesticide risk

assessments. At present, however, the

Agency does not know how to apply the

information in its files concerning

common mechanism issues to risk

assessments, and therefore believes that

in most cases there is no ‘‘available

information’’ concerning common

mechanism that can be scientifically

applied to tolerance decisions. Where it

is clear that a particular pesticide may

share a significant common mechanism

with other chemicals, or where it is

clear that a pesticide does not share a

common mechanism with other

chemicals, a tolerance decision may be

affected by common mechanism issues.

The Agency expects that most tolerance

decisions will fall into the area in

between, where EPA cannot reasonably

determine whether a pesticide does or

does not share a common mechanism of

toxicity with other chemicals (and, if so,

how that common mechanism should be

factored into a risk assessment). In such

circumstances, the Agency will reach a

tolerance decision based on the best,

currently-available and usable

information, without regard to common

mechanism issues. However, the

Agency will also revisit such decisions

when the Agency determines how to

apply common mechanism information

to pesticide risk assessments.

In the case of sulfentrazone, EPA has

determined that it does not now have

the capability to apply the information

in its files to a resolution of common

mechanism issues in a manner that

would be useful in a risk assessment.

This tolerance determination therefore

does not take into account common

mechanism issues. The Agency will

reexamine the tolerances for

sulfentrazone, if reexamination is

appropriate, after the Agency has

determined how to apply common

mechanism issues to its pesticide risk

assessments.

III. Determination of Safety for U.S.

Population and Children

1. The U.S. population. Based on a

NOEL of 14 mg/kg/day body weight

(bwt)/day from a two-generation rat

reproduction study that demonstrated

histopathological findings in testes and

epididymides of second generation

males as an endpoint, and using an

uncertainty factor of 1,000, the Agency

has determined a reference dose (RfD) of

0.014 mg/kg bwt/day for this assessment

of risk. The extra factor of 10 and the

uncertainty factor of 1,000 is to provide
10706 Federal Register / Vol. 62, No. 46 / Monday, March 10, 1997 / Rules and Regulations

added protection for infants and

children. Based on the available toxicity

data and the available exposure data

identified above, the proposed

tolerances will utilize 16.7% of the RfD

for the U.S. population. Including an

estimated exposure of 37 ppb in potable

water, and assuming the injection of two

liters of water per day, the dietary

exposure for the U.S. adult population

is increased and utilizes approximately

25% of the RfD.

2. Children (1 to 6 years old). Using

the RfD of 0.014 mg/kg bwt/day, as

described above, and a Theoretical

Maximum Residue Contribution

(TMRC) of 0.005437 mg/kg bwt/day

determined for children (1 to 6 years

old), the proposed tolerances will utilize

38.8% of the RfD. Including an

estimated exposure of 37 ppb in potable

water, and assuming the injection of 1

liter of water per day, the dietary

exposure for children (1 to 6 years old)

population is increased and utilizes

approximately 65% of the RfD.

3. Non-food uses. There are no nonfood uses of sulfentrazone registered

under the Federal Insecticide, Fungicide

and Rodenticide Act, as amended.

IV. Determination of Safety for Infants

and Children

Risk to infants and children was

determined by use of developmental

toxicity studies in rats and a twogeneration reproduction study in rats.

The oral developmental toxicity studies

resulted in a maternal NOEL of 25 mg/

kg/day based on decreased body weight

gain, increased spleen weight, and

microscopic changes in the spleen, and

a fetal NOEL of 10 mg/kg/day based on

fetal death, reduced body weights, and

alterations in skeletal development at

higher doses. A dermal developmental

toxicity study in rats resulted in a

developmental (fetal) NOEL of 100 mg/

kg/day based on decreased fetal body

weight and increased incidences of fetal

alterations, comprised primarily of

skeletal variations and reductions in

mean numbers of ossification sites. A

two-generation reproduction study in

rats resulted in a NOEL for systemic and

reproductive/developmental parameters

of 14 mg/kg/day for males and 16 mg/

kg/day for females. The LOEL for

systemic and reproductive/development

parameters was 33 mg/kg/day for males

and 40 mg/kg/day for females. Systemic

effects were comprised of decreased

body weight gains, and reproductive/

developmental effects at the LOEL

included degeneration and/or atrophy of

the testes, with epididymal sperm

deficits in the second (F1) generation

males. Male fertility in the F1

generation was reduced at higher doses;

litter size, pup survival and pup body

weight for both generations were also

effected at higher doses.

FFDCA section 408 provides that EPA

shall apply an additional safety factor

for infants and children in the case of

threshold effects to account for pre- and

post-natal toxicity and the completeness

of the data base, unless EPA determines

that such an additional factor is not

necessary to protect the safety of infants

and children. Based on current data

requirements, the data base relative to

pre- and post-natal toxicity is complete.

EPA has determined that the toxicology

data profile for sulfentrazone contains

clear, unequivocal evidence that this

chemical causes developmental and

reproductive toxicity. Based upon the

available data and toxicity profile, the

Agency RfD Peer Review Committee

considered sulfentrazone to be a

relatively potent reproductive/

developmental toxicant, and determined

that an additional 10-fold uncertainty

factor for the protection of infants and

children was warranted.

This decision was based upon the

data described above. The following

facts were considered in reaching this

conclusion:

(1) The lowest NOEL for chronic

exposure, which is used to determine

the RfD, is based upon severe,

irreversible reproductive/developmental

effects, observed in the two-generation

reproduction study in rats.

(2) Developmental toxicity was

observed in the absence of maternal

effects in the prenatal developmental

toxicity studies in rats (developmental

NOELs were lower than maternal

NOELs). This apparent increased

sensitivity of the fetuses occurred

following administration of

sulfentrazone by either the dermal or

the oral route, both of which are

relevant to human exposure.

(3) A steep dose-response curve exists

for the reproductive and developmental

endpoints of concern. The reproductive

and/or developmental LOELs for the

prenatal developmental toxicity studies

in rats and the two-generation

reproduction study are only

approximately 2.5 times greater than the

corresponding NOELs in each of these

studies. The reproductive and

developmental NOELs are extremely

low (i.e., in the range of 10 to 13 mg/

kg/day). Additionally, in the rat prenatal

developmental toxicity and twogeneration reproduction studies, the

reproductive/developmental effects

increase in incidence and/or severity at

higher doses.

(4) The reproductive/developmental

toxicity profile is consistent and

reproducible, providing a large measure

of confidence in the endpoints and dose

levels.

The percent of the RfD that will be

utilized by the aggregate exposure to

sulfentrazone for the most exposed

subgroup would be 65% for children (1

to 6 years old) Therefore, EPA

concludes that there is a reasonable

certainty that no harm will result to

infants and children from aggregate

exposure.

V. 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 or reproductive toxicology

studies described above. There was no

observed pathology of the endocrine

organs in these studies. There is no

evidence at this time that sulfentrazone

causes endocrine effects.

2. Metabolism in plants and animals.

The metabolism of sulfentrazone in

plants and animals is adequately

understood for the purposes of these

tolerances. Crop residues found after the

pre-emergence use were the major

metabolites 3-hydroxymethyl

sulfentrazone and 3-desmethyl

sulfentrazone. In rotational crops,

sulfentrazone is metabolized via four

different pathways: (i) Oxidation of the

3-methyl group to form 3-

hydroxymethyl sulfentrazone, followed

by further oxidation to form

sulfentrazone carboxylic acid which is

decarboxylated to 3-desmethyl

sulfentrazone; (ii) hydrolysis of the

trifluoromethyl group to form

desdifluoromethyl sulfentrazone which

is oxidized and decarboxylated to form

desdifluoromethyl desmethyl

sulfentrazone; (iii) hydrolysis of the

sulfonamide group to form

desmethylsulfonyl sulfentrazone; and

(iv) scission of the phenyl and triazole

rings to produce methyl triazole. The

corresponding phenyl metabolites are

believed to remain bound. In animal

metabolism sulfentrazone per se was the

predominant component of the residue.

The metabolite 3-hydroxymethyl

sulfentrazone was also identified. It was

determined by EPA that a soybean

tolerance based on the parent and 3-

hydroxymethyl sulfentrazone is

therefore appropriate.

3. Analytical method. There is a

practical analytical method for detecting

and measuring levels of sulfentrazone

and its metabolites in or on food with

a limit of detection that allows

monitoring of food with residues at or

above the levels set in these tolerances.

The proposed analytical method for

determining residues is hydrolysis
Federal Register / Vol. 62, No. 46 / Monday, March 10, 1997 / Rules and Regulations 10707

followed by gas chromatographic

separation. EPA will provide

information on this method to the Food

and Drug Administration. Because of

the long lead time from establishing

these tolerances to publication the

enforcement methodology is being made

available in the interim to anyone

interested in pesticide enforcement

when requested by mail from: Calvin

Furlow, Public Response Branch, Field

Operations Division (7506C), Office of

Pesticide Programs, Environmental

Protection Agency, 401 M St., SW.,

Washington, DC 20460. Office location

and telephone number: Rm. 1130A, CM

#2, 1921 Jefferson Davis Highway,

Arlington, VA 22202, (703) 305-5937.

4. International tolerances. There are

no Codex Alimentarius Commission

(Codex) Maximum Residue Levels

(MRLs) for sulfentrazone.

5. Data Gaps. Data gaps currently

exist for a 21-day dermal study in

rabbits, in vivo cytogenetics dominant

lethal assay in rats, a wheat processing

study, additional rice field trials and

residue data for sorghum aspirated grain

fractions. Based on the toxicological

data and the levels of exposure, EPA has

determined that the proposed tolerances

will be safe.

VI. Summary of Findings

The analysis for sulfentrazone using

tolerance level residues shows the

proposed uses on soybeans will not

cause exposure to exceed the levels at

which the Agency believes there is an

appreciable risk. All population

subgroups examined by EPA are

exposed to sulfentrazone residues at

levels below 100% of the RfD for

chronic effects.

Based on the information cited above,

the Agency has determined that the

establishment of the tolerances by

adding a new section to 40 CFR part 180

will be safe; therefore, the tolerances are

established as set forth below.

VII. Objections and Hearing Requests

The new FFDCA section 408(g)

provides essentially the same process

for persons to ‘‘object’’ to a tolerance

regulation issued by EPA under new

section 408(e) and (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

appropriate adjustments to reflect the

new law.

Any person may, by May 9, 1997, file

written objections to any aspect of this

regulation (including the automatic

revocation provision) 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.

VIII. Public Docket

A record has been established for this

rulemaking under docket control

number PF–670/OPP–300459. 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 Rm. 1132 of the

Public Response and Program Resources

Branch, Field Operation Division

(7506C), Office of Pesticide Programs,

Environmental Protection Agency,

Crystal Mall #2, 1921 Jefferson Davis

Highway, Arlington, VA. EPA has also

established a special record for postFQPA tolerances which contains

documents of general applicability. This

record can be found in the same

location.

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.

IX. 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.

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).
10708 Federal Register / Vol. 62, No. 46 / Monday, March 10, 1997 / Rules and Regulations

List of Subjects in 40 CFR Part 180

Environmental protection,

Administrative practice and procedure,

Agricultural commodities, Pesticides

and pests, Reporting and recordkeeping

requirements.

Dated: February 27, 1997.

Daniel M. Barolo,

Director, Office of Pesticide Programs.

Therefore, 40 CFR part 180 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 § 180.498 to read as

follows:

§ 180.498 Sulfentrazone; tolerances for

residues.

(a) Tolerance--general. A tolerance is

established for combined residues of the

herbicide sulfentrazone N-[2,4-dichloro5-[4-(difluoromethyl)-4,5-dihydro-3-

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

yl]phenyl]methanesulfonamide and its

major metabolite 3-hydroxymethyl

sulfentrazone N-[2,4-dichloro-5-[4-

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

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

yl]phenyl]methanesulfonamide in or on

the following raw agricultural

commodity:

Commodity Parts per

million

Soybean, seed .......................... 0.05

(b) Tolerances--inadvertent and

indirect residues. Tolerances are

established for inadvertent and indirect

combined residues of the herbicide

sulfentrazone (N-[2,4-dichloro-5-[4-

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

yl]phenyl]methanesulfonamide) and its

metabolites 3-hydroxymethyl

sulfentrazone (N-[2,4-dichloro-5-[4-

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

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

yl]phenyl]methanesulfonamide) and 3-

desmethyl sulfentrazone (N-[2,4-

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

dihydro-5-oxo-1H-1,2,4-triazol-lyl]phenyl]methanesulfonamide) in or on

the following raw agricultural

commodities when present therein as a

result of the application of sulfentrazone

to growing crops.

Commodity Parts per

million

Cereal Grains (excluding sweet

corn), Bran ............................ 0.15

Cereal Grains (excluding sweet

corn), Forage ......................... 0.2

Cereal Grains (excluding sweet

corn), Grain ........................... 0.1

Cereal Grains (excluding sweet

corn), Hay .............................. 0.2

Cereal Grains (excluding sweet

corn), Hulls ............................ 0.30

Cereal Grains (excluding sweet

corn), Stover .......................... 0.1

Cereal Grains (excluding sweet

corn), Straw ........................... 0.6

[FR Doc. 97–5874 Filed 3–7–97; 8:45 am]

BILLING CODE 6560–50–F

GENERAL SERVICES

ADMINISTRATION

41 CFR Parts 302–1, 302–2, 302–3,

302–7, 302–8, 302–9, and 302–11

[FTR Amendment 58]

RIN 3090–AG17

Federal Travel Regulation; Authority

for the Administrator of General

Services To Issue Regulations;

Authority To Waive Limitations on

Relocation Allowances When an

Employee Is Relocated To or From a

Remote or Isolated Location; Technical

Correction To Relocation Income Tax

(RIT) Allowance

AGENCY: Office of Governmentwide

Policy, GSA.

ACTION: Final rule.

SUMMARY: This final rule amends the

Federal Travel Regulation (FTR) to

reflect the direct authority conferred by

statute on the Administrator of General

Services to issue regulations

implementing subchapter II of chapter

57 of title 5, United States Code, and to

authorize agencies to waive certain

statutory and regulatory limitations for

an employee relocating to or from a

remote or isolated location. This

amendment also makes a technical

correction to the RIT allowance. The

amendment implements statutory

changes, and is intended to improve the

treatment of an employee transferred to

a remote or isolated location.

DATES: This final rule is effective March

22, 1997.

Applicability: This rule applies to an

employee whose effective date of

transfer (date the employee reports for

duty at the new official station) is on or

after March 22, 1997.

FOR FURTHER INFORMATION CONTACT:

Robert A. Clauson, Travel and

Transportation Management Policy

Division (MTT), Washington, DC 20405,

telephone 202–501–0299.

SUPPLEMENTARY INFORMATION: On

September 23, 1996, the President

signed into law the Federal Employee

Travel Reform Act of 1996 (Pub. L. 104–

201). Section 1722 of the Act transfers

from the President to the Administrator

of General Services authority to issue

regulations implementing subchapter II

of chapter 57 of title 5, United States

Code, unless otherwise specified in

subchapter II. Previously, the

Administrator had exercised

implementation authority under E.O.

11609, 36 FR 13747, 3 CFR, 1971–1975

Comp., p. 586; E.O. 12466, 49 FR 7349,

3 CFR, 1984 Comp., p. 165; and E.O.

12522, 50 FR 26337, 3 CFR, 1985

Comp., p. 375. This amendment reflects

the statutory change of authority.

Section 1722 of the Act also directs

the Administrator to authorize heads of

agencies or their designees to waive any

limitation in subchapter II of chapter 57

of title 5, United States Code, or in any

implementing regulation for an

employee relocating to or from a remote

or isolated location who otherwise

would suffer hardship. This amendment

implements the limitation waiver

provisions of section 1722 of the Act.

This amendment also makes a

technical correction to the RIT

allowance. The withholding rate for

supplemental wages was raised from 20

percent to 28 percent in 1995. This

amendment modifies the withholding

tax allowance (WTA) provisions to

reflect the 28 percent withholding rate.

The General Services Administration

has determined that this rule is not a

significant regulatory action for the

purposes of Executive Order 12866 of

September 30, 1993. This final rule is

not required to be published in the

Federal Register for notice and

comment. Therefore, the Regulatory

Flexibility Act does not apply. This rule

also is exempt from Congressional

review prescribed under 5 U.S.C. 801

since it relates solely to agency

management and personnel.

List of Subjects in 41 CFR Parts 302–1,

302–2, 302–3, 302–7, 302–8, 302–9, and

302–11

Government employees, Income taxes,

Relocation allowances and entitlements,

Transfers.

For the reasons set out in the

preamble, 41 CFR parts 302–1, 302–2,

302–3, 302–7, 302–8, 302–9, and 302–11

are amended to read as follows: