Federal Register / Vol. 62, No. 185 / Wednesday, September 24, 1997 / Notices 49983

sodium. When the weight of these facts

is considered an additional safety factor

is not warranted for developmental

effects. As stated above, aggregate

exposure assessments utilized

significantly less than 1% of the RfD for

either the entire U.S. population or any

of 22 population subgroups including

infants and children. Therefore, it may

be concluded that there is reasonable

certainty that no harm will result to

infants and children from aggregate

exposure to pyrithiobac sodium

residues.

F. International Tolerances

There are no established Codex MRLs

for pyrithiobac sodium on cottonseed.

An established Mexican tolerance for

pyrithiobac sodium on cottonseed is

identical to the U.S. tolerance.

Compatibility is not a problem at this

time.

[FR Doc. 97–25234 Filed 9-23-97; 8:45 am]

BILLING CODE 6560–50–F

ENVIRONMENTAL PROTECTION

AGENCY

[PF–761; FRL–5740–9]

Yoshitomi Fine Chemicals Ltd.;

Pesticide Tolerance Petition Filing

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Notice.

SUMMARY: This notice announces the

initial filing of a pesticide petition

proposing the establishment of

tolerances for residues of 4,5-Dichloro1,2-Dithiol-3-one (CASRN 1192–52–5)

in or on paper and paperboard.

DATES: Comments, identified by the

docket control number PF–761, must be

received on or before October 24, 1997.

ADDRESSES: By mail submit written

comments to: Information and Records

Integrity Branch, Public Information and

Services Divison (7506C), Office of

Pesticides Programs, Environmental

Protection Agency, 401 M St., SW.,

Washington, DC 20460. In person bring

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

Jefferson Davis Highway, Arlington, VA.

Comments and data may also be

submitted electronically by following

the instructions under

‘‘SUPPLEMENTARY INFORMATION.’’

No confidential business information

should be submitted through e-mail.

Information submitted as a comment

concerning this document may be

claimed confidential by marking any

part or all of that information as

‘‘Confidential Business Information’’

(CBI). CBI should not be submitted

through e-mail. Information marked as

CBI will not be disclosed except in

accordance with procedures set forth in

40 CFR part 2. A copy of the comment

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. All written

comments will be available for public

inspection in Rm. 1132 at the address

given above, from 8:30 a.m. to 4 p.m.,

Monday through Friday, excluding legal

holidays.

FOR FURTHER INFORMATION CONTACT: By

mail: Portia Jenkins, Acting Product

Manager (34), Antimicrobials Division

(7510C), Office of Pesticide Programs,

Environmental Protection Agency, 401

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

Office location and telephone number:

Rm. 6C, Crystal Plaza #1, 2800 Crystal

Drive, Arlington, VA, (703) 308–6230; email: jenkins.portia@epamail.epa.gov.

SUPPLEMENTARY INFORMATION: EPA has

received a pesticide petition ((PP)

7F4902) from Yoshitomi Fine

Chemicals, Ltd., 6–9, Hiranomachi 2-

chome, Chuo-ku, Osaka, 541, Japan,

proposing pursuant to section 408(d) of

the Federal Food, Drug and Cosmetic

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

amend 40 CFR 185 ‘‘Tolerances for

Pesticides in Food’’ by establishing

Subpart D ‘‘Tolerance Exemptions for

Pesticides in Foods’’ and promulgating

therein section 185.9000 establishing a

tolerance exemption for residues of the

slimicide 4,5-Dichloro-1,2-Dithiol-3-one

(CASRN 1192–52–5) in or on paper and

paperboard resulting from its addition

to pulp and paper mill process water to

control slime forming organisms. EPA

has determined that the petition

contains data or information regarding

the elements set forth in section

408(d)(2); however, EPA has not fully

evaluated the sufficiency of the

submitted data at this time or whether

the data supports granting of the

petition. Additional data may be needed

before EPA rules on the petition.

The official record for this notice of

filing, as well as the public version, has

been established for this notice of filing

under docket control number [PF–761]

(including comments and data

submitted electronically as described

below). A public version of this record,

including printed, paper versions of

electronic comments, which does not

include any information claimed as CBI,

is available for inspection from 8:30

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

excluding legal holidays. The official

record is located at the address in

‘‘ADDRESSES’’.

Electronic comments can be sent

directly to EPA at:

opp-docket@epamail.epa.gov

Electronic comments must be

submitted as an ASCII file avoiding the

use of special characters and any form

of encryption. Comment and data will

also be accepted on disks in

Wordperfect 5.1 file format or ASCII file

format. All comments and data in

electronic form must be identified by

the docket number (PF–761) and

appropriate petition number. Electronic

comments on this notice may be filed

online at many Federal Depository

Libraries.

List of Subjects

Environmental protection,

Administrative practice and procedure,

Paper and paperboard, Slimicides,

Pesticides and pests, Reporting and

recordkeeping requirements.

Dated: September 16, 1997.

Frank Sanders,

Director, Antimicrobials Division, Office of

Pesticide Programs.

Summary of Petition

Petitioner summary of the pesticide

petition is printed below as required by

section 408(d)(3) of the FFDCA. The

summary of the petition was prepared

by the petitioner and represent the

views of the petitioner. The petition

summary announces the availability of

a description of the analytical methods

available to EPA for the detection and

measurement of the pesticide chemical

residues or an explanation of why no

such method is needed.

Yoshitomi Fine Chemicals, Ltd.

A. Residue Chemistry

This petition is not for residues in or

on raw agricultural commodities. It is

for residues in or on food contact paper

or paperboard. Accordingly, the residue

chemistry data submitted are solely for

the residues remaining in food contact

paper and paperboard when the subject

slimicide (4,5-Dichloro-1,2-Dithiol-3-

one, CASRN 1192–52–5, hereafter

referred to as RYH–86) is used in pulp

and paper mill process water to control

slime forming organisms.

1. Residues in paper and paperboard.

GC-MS-SIM analysis of approximately

30 paper and paperboard samples

manufactured in a papermill which

used RYH–86 amended slurry water

revealed no RYH–86 detectable with a

detection limit of 100 μg/kilograms (Kg)

of paper (i.e., 100 parts per billion

(ppb)). Extraction of such samples with
49984 Federal Register / Vol. 62, No. 185 / Wednesday, September 24, 1997 / Notices

1 Suggesting that the more typical forms of preneoplastic lesions or lesions which have been

associated with indirect carcinogenesis, and which

can often be observed already within 90–day

studies, are not present.

food simulating solvents (FSL’s), using

standard FDA methods for determining

food additive extractives from foodcontact materials which allowed for the

equilibration of RYH–86 between the

paper and paperboard samples and the

FSL’s for 10–days, revealed no RYH–86

migration into FSL’s at detection limits

of 10 μg/Kg for aqueous FSL’s and 100

μg/Kg for fatty FSL’s (using the same

GC-MS-SIM method for analysis).

2. Analytical method. This is a

tolerance exemption petition and,

accordingly, no enforcement analytical

method is proposed.

B. Toxicological Profile

1. Acute toxicity. Technical RYH–86

(99.8% active ingredient) is moderately

toxic by the oral route, with acute oral

LD50 of 350 milligrams/kilograms (mg/

kg) in the male rat and 372 mg/kg in the

female rat (MRID 41562401). Technical

RYH–86 is practically nontoxic by

dermal application (acute dermal LD50 >

5,000 mg/kg) but was quite irritant to

the skin (severe skin irritation and

dermal necrosis but no mortalities were

observed) in an acute dermal toxicity

and irritation study (MRIDs 41531114 &

41562402). The acute inhalation toxicity

of RYH–86 was waived by EPA during

review of the registration for RYH–86

Slimicide (EPA Reg. No. 63898–1) due

to its being applied only by injection

into process water and the resulting lack

of significant inhalation exposure

potential. Guideline 81–4 and 81–5

primary eye and skin irritation studies

for RYH–86 manufacturing use product

(about 50% RYH–86) showed it to

produce severe ocular damage and

severe skin irritation (MRIDs 41531115

& 41531116). In these same studies,

technical RYH–86 was a severe eye

irritant and a moderate skin irritant.

Tested at 1% solution (to minimize

irritancy effects) RYH–86 was not a

dermal sensitizer (MRID 41531117).

2. Subchronic toxicity. The evaluation

of the subchronic toxicity of RYH–86

has been carried out in 2 separate

studies which, together with a bridging

analysis of both, constitute one 3-

volume data set which was previously

reviewed by EPA during the registration

review for RYH–86 Slimicide (EPA Reg.

No. 63898–1: MRIDs 41531118,

41531119, & 41531120). In these

studies, one study used relatively high

doses of RYH–86 and the other used

lower doses. The principal effect of note

in these studies was gastrointestinal

irritation exhibiting as a thickening of

the gastric mucosa and, at sufficiently

high dose, ulceration. The No Observed

Effects Level (NOEL) for these effects

was 3.8 mg/Kg/day and the Lowest

Observed Effects Level (LOEL) was 5.0

mg/Kg/day. Other effects seen included:

an increase in relative renal weight in

males only (LOEL 5.0 mg/Kg/day, NOEL

3.8 mg/Kg/day); an increase in relative

testicular weight and liver weight (LOEL

12 mg/Kg/day, NOEL 5.0 mg/Kg/day);

possible GI complications related

mortality (LOEL 45 mg/Kg/day, NOEL

15 mg/Kg/day); and miscellaneous

effects on clinical chemistry, ketonuria,

body weight depression, and clinical

signs of distress (LOEL 45 mg/Kg/day,

NOEL 15 mg/Kg/day).

3. Chronic toxicity. Chronic toxicity

studies (2–year rat and 1–year dog) have

not been conducted with RYH–86 due

to the fact that its intended use pattern:

(a) does not involve a potential for

chronic occupational exposure; (b) leads

to only negligible dietary exposure [see

below]; and, (c) the only notable adverse

effect observed in subchronic gavage

studies with the rat was GI irritation /

ulceration [see above]. Accordingly,

Yoshitomi Fine Chemicals, Ltd.

considers that significant chronic

exposure is not an issue for RYH–86 as

it is to be used and that the subchronic

studies do not suggest that any unusual

toxicity (other than GI irritation which

is likely to be dose-limiting) will likely

be seen in chronic toxicity studies.

Indeed, the registration of RYH–86

Slimicide (EPA Reg. No. 63898–1) was

supported by the Antimicrobials Data

Call-in set of requirements and these

provide specifically that chronic

toxicity and oncogenicity studies for

antimicrobial agents are required only if

the results of subchronic toxicity or of

gene toxicity studies indicate a potential

concern or if there will, in fact, be

significant chronic exposure.

4. Oncogenicity. Oncogenicity studies

(2–year rat and 18–months mouse) have

not been conducted with RYH–86 due

to the fact that its intended use pattern:

(a) does not involve a potential for

chronic or long term, frequent

occupational exposure; (b) leads only to

negligible dietary exposure [see below];

(c) the only notable adverse effect

observed in subchronic gavage with the

rat was GI irritation / ulceration with no

evidence for metaplasia, dysplasia,

altered foci, or peroxisome proliferation

observed1; and, (d) RYH–86 is not

mutagenic or genotoxic (see No. 6,

below). Accordingly, Yoshitomi Fine

Chemicals, Ltd. considers that

significant chronic exposure is not an

issue for RYH–86 as it is to be used and

that the subchronic studies do not

suggest that any unusual toxicity (other

than GI irritation which is likely to be

dose-limiting) or oncogenicity is likely

to be seen in chronic toxicity /

oncogenicity studies. Indeed, the

registration of RYH–86 Slimicide (EPA

Reg. No. 63898–1) was supported by the

Antimicrobials Data Call-in set of

requirements and these provide

specifically that chronic toxicity and

oncogenicity studies for antimicrobial

agents are required only if the results of

subchronic toxicity or of gene toxicity

studies indicate a potential concern or

if there will, in fact, be significant

chronic exposure.

5. Developmental toxicity. i. Rats - A

standard Guideline 83–3 design

teratology and developmental effects

study (MRID 42680801) was conducted

in which maternal toxicity (as

evidenced by decreases in body weight,

body weight gain, food consumption,

and thickening of the stomach mucosa)

was observed at 45 mg/Kg/ day. At this

dose (the highest dose tested) no

developmental or teratological effects

were observed. In this study, doses of 15

mg/Kg and lower were not toxic to the

dams and there were no developmental

or teratological effects at these lower

doses. The dose selection for this study

was based on the observed GI effects in

the rat 90–day gavage study.

ii. Rabbits or mice - Based on: (a) the

lack of any suggestion of teratological or

developmental effects at doses which

produced frank maternal toxicity in the

rat; (b) that the toxicity of RYH–86 in

the rat study appeared to be largely a

function of its GI effects; and, (c) the

low exposure potential associated with

RYH–86 in its intended uses, Yoshitomi

Fine Chemicals, Ltd. considers that

conduct of a second species

developmental effect study is not

needed to characterize the toxicology of

RYH–86. Indeed, the registration of

RYH–86 Slimicide (EPA Reg. No.

63898–1) was supported by the

Antimicrobials Data Call-in set of

requirements and these provide

specifically that second species

developmental toxicity studies for

antimicrobial agents are required only if

the results of studies in the first species

indicate a potential concern or if there

will, in fact, be significant exposure to

females of child bearing age. The

conclusion that a second species

developmental toxicity study for RYH–

86 is not needed has been reached to

date by the Swedish, Finnish, and

Canadian regulatory authorities in

addition to EPA.

6. Genotoxicity. In the standard Ames

test (5-strains), RYH–86 is nonmutagenic with or without metabolic

activation (MRID 42897501). In the

mouse, in vivo, bone marrow
Federal Register / Vol. 62, No. 185 / Wednesday, September 24, 1997 / Notices 49985

2 U.S. FDA (1985), ‘‘Recommendations for

Chemistry Data for Indirect Food Additive

Petitions’’, Center for Food Safety and Applied

Nutrition, June 1995.

3 Which considers that ‘‘food’’ consists of solid

foods as well as beverages consumed.

4 The adult calorie requirement is 2,400 cal/day

for males and females averaged and this in a 3 Kg

daily diet provides for calorie density of 800 cal/

Kg. For comparison, human breast milk has a

calorie density of 700 cal/Kg.

micronucleus test RYH–86 did not

induce chromosome aberrations (MRID

41531122). In the rat hepatocyte UDS

(unscheduled DNA synthesis) test,

RYH–86 did not induce unscheduled

DNA synthesis (MRID 41531123). On

the basis of this genotoxicity battery,

Yoshitomi Fine Chemicals, Ltd.

concludes that RYH–86 is not

mutagenic or genotoxic.

7. Metabolism. Specific mammalian

metabolism studies with RYH–86 have

not been conducted for the following

reasons: (a) at the alkaline pH of the

small intestine, RYH–86 will hydrolyze

rapidly with release of chloride and

active chlorine; and, (b) the toxicology

profile for RYH–86 indicates that the

principle effect of RYH–86 is GI

irritancy and that metabolism does not

appear to play a significant role in the

toxicology of RYH–86. Therefore,

Yoshitomi Fine Chemicals, Ltd.

considers that mammalian metabolism

studies in the rat with RYH–86 will not

provide additional useful information

on the safety of RYH–86 and such

studies were not required by EPA to

support the registration of RYH–86

Slimicide (EPA Reg. No. 63898–1).

8. Reference Dose (RfD). EPA has not

previously set a RfD for RYH–86 since

at the time of registration review for

RYH–86 Slimicide (EPA Reg. No.

63898–1) the regulation of RYH–86

residues in food contact paper and

paperboard was under the jurisdiction

of the Food and Drug Administration

(FDA). Enactment of the Food Quality

Protection Act transferred jurisdiction

over these residues to EPA. Based on the

subchronic NOEL of 3.8 mg/Kg/day (for

gastro-intestinal (GI) irritation effects)

and an uncertainty factor (UF) of 100,

Yoshitomi Fine Chemicals, Ltd.

proposes an RfD set at 0.038 mg/Kg/day

for RYH–86. Such an RfD leads to the

following allowable daily intakes (ADI)

for adult males and females and for

children: Adult male, 70 Kg, ADI = 2.7

mg/day; Adult female, 60 Kg, ADI = 2.3

mg/day; Child, 20 Kg, ADI = 0.76 mg/

day. Yoshitomi Fine Chemicals, Ltd. has

considered the possible special

sensitivity to RYH–86 of infants and

children and, also, of sensitive

individuals. The proposed RfD is based

on a physico-chemical effect of RYH–86:

gastro-intestinal irritation. This,

Yoshitomi Fine Chemicals, Ltd. suggests

is not an effect for which any wide

differences between infants / children

and adults would be expected on a

reasonable scientific basis. The irritant

effects of RYH–86 on the GI tract are

expected to be a function of the

concentration of RYH–86 in the GI tract

and this will be a function of amount of

RYH–86 per unit of body weight. Thus,

an RfD set at 0.038 mg/Kg/day will lead

to similar GI tract concentrations of

RYH–86 in adults, children, and infants.

Also, since the effect of irritation is a

physico-chemical effect, the existence of

metabolic differences among persons is

not reasonably expected to be a factor

producing individuals with special

sensitivity to RYH–86. Also, since: (a)

physico-chemical effects like irritancy

usually do not at all occur well below

a threshold concentration of irritant;

and, (b) the RfD is based on gavage

studies in which RYH–86 is directly

delivered to the gastric compartment

whereas daily dietary consumption of

the RfD amount leads to a lower peak

GI tract level than would occur after

gavage administration of the RfD

amount, it can be expected that even for

persons with pre-existing conditions

such as ulcers, colitis, and similar

pathologies that dietary exposures to

RYH–86 at levels up to the proposed

RfD will not exacerbate such conditions.

Therefore, Yoshitomi Fine Chemicals,

Ltd. believs that the proposed RfD is

suitable for adults, children, infants,

and persons with pre-existing GI tract

disturbances.

C. Aggregate Exposure

1. Dietary exposure —— i. Food. GCMS-SIM analysis of approximately 30

paper and paperboard samples

manufactured in a papermill which

used RYH–86 amended slurry water

revealed no detectable RYH–86 with a

detection limit of 100 μg/Kg of paper

(i.e., 100 ppb). Extraction of such

samples with food simulating solvents

(FSL’s), using standard FDA methods

for determining food additive

extractives from food-contact materials

which allowed for the equilibration of

RYH–86 between the paper and

paperboard samples and the FSL’s for

10-days, revealed no RYH–86 migration

into FSL’s at detection limits of 10 μg/

Kg for aqueous FSL’s and 100 μg/Kg for

fatty FSL’s (using the same GC-MS-SIM

method for analysis). Using a standard

equation provided by U.S. FDA for

estimating dietary exposure to indirect

food additives migrating from food

packaging2, the hypothetical worst case

potential for dietary exposure to RYH–

86 as a result of migration into foods of

RYH–86 residuals in food contact paper

and paperboard is:

<M> = faqueous and acidic (M10 percent ethanol) +

f alcohol (M50 percent ethanol) + ffatty (Mfatty)

In which, for un-coated food contact

paper and paperboard, the food type

distribution factors (ffood type) are:

faqueous and acidic 0.57 + 0.01 = 0.58

falcohol 0.01

ffatty 0.41

and <M> is the concentration of

residues in food when the solvent to

sample extraction ratio is 10 ml/sq. inch

of sample surface (which was the case

for Yoshitomi Fine Chemicals, Ltd.’s

residue migration potential studies).

For the worst case, since no RYH–86

was detected in any of the FSLs,

Yoshitomi Fine Chemicals, Ltd. has

taken the migration values (M) which

would result if RYH–86 were present in

the FSLs at the limit of detection for the

relevant food simulating solvent type:

M10 percent ethanol 10 μg/Kg

M50 percent ethanol 10 μg/Kg

Mfatty 100 μg/Kg

In which case the overall migrant

load, <M> is:

<M> = (0.58 × 10 μg/Kg) + (0.01 × 10 μg/

Kg) + (0.41 × 100 μg/Kg) = 47 μg/Kg

The above value of <M> can then be

used for derivation of the estimated

daily intake (EDI) for adults from the

following FDA formula:3

EDI = 3.0 Kg food/day × <M> × CF

where CF is the consumption factor

for foods contacted by a given type of

material. In the case of paper and

paperboard, CF = 0.1 for uncoated paper

(see footnote 2). Therefore, as a worst

case, the potential adult EDI for RYH–

86 which derives from possible

residuals in food contact paper and

paperboard is:

EDI = 3.0 Kg food/day × 47 μg/Kg food ×

0.1 = 14.1 μg/day

For children, the daily diet is different

in quantity. At 6 months age, the daily

caloric requirement is 110 cal/Kg body

weight and the mean body weight for 6

months infants is 8 Kg. This equates to

an 880 Kg/day diet which at an average

of 800 cal/Kg4 is a 1.1 Kg total diet. In

the age interval 4 years to 6 years of age

(median body weight 20 Kg), the daily

calorie requirement is 1,600 cal/day

which equates to a 2 Kg total daily diet.

The EDI’s for infants and children are

based on these total diet amounts:

EDIINFANT = 1.1 Kg food/day × 47 μg/Kg ×

0.1 = 5.2 μg/day

EDICHILD = 2.0 Kg food/day × 47 μg/Kg ×

0.1 = 9.4 μg/day

Thus, for a 6 month old infant, for a

20 Kg child (age 4–6), for a 60 Kg
49986 Federal Register / Vol. 62, No. 185 / Wednesday, September 24, 1997 / Notices

woman, and for a 70 Kg man, the daily

intakes associated with the above EDI,

expressed as μg/Kg/day and as percent

RfD utilization are:

Dietary Exposure

Percent

RfD Utilized

Infant 0.65 μg/Kg/

day

1.71

Child 0.47 μg/Kg/

day

1.24

Woman 0.24 μg/Kg/

day

0.632

Man 0.20 μg/Kg/

day

0.526

Yoshitomi Fine Chemicals, Ltd. notes

that at 40 CFR 180.1(l) EPA has defined

that a ‘‘negligible residue ... Ordinarily

... will add to the diet an amount which

will be less than 1/2,000th of the

amount that has been demonstrated to

have no effect from feeding studies on

the most sensitive animal species

tested.’’ This, for a 100-fold uncertainty

factor based RfD, means an RfD

utilization of 5% or less. Yoshitomi

considers, therefore, that under the

hypothetical worst case dietary

exposure assessment RYH–86 residues

are clearly negligible residues.

i. Drinking water. The use of RYH–86

as a slimicide for pulp and paper mills

does not provide for entry of RYH–86

into drinking water sources. Spent

process water from such sites is treated

as waste water, typically on-site, prior to

release into surface waters. In a Finnish

paper mill, with a use level of 1.5 ppm

in the water (as an initial load to the

slurry water) no RYH–86 was detected

in air or water at sites by the paper

making machine (detection limits were

4.5 ng/L in water and 3×10–6 mg/dm3).

Water samples which were examined

included samples from the waste water

holding pond and discharge from the

on-site waste water treatment plant.

2. Non-dietary exposure. RYH–86 is

an industrial-use slimicide whose only

other registered use (i.e., aside from

slimicide use in pulp and paper mills)

is as a slime control agent in recirculating cooling water. All of the uses

of RYH–86 involve only occupational

exposures. There are no registrations

and no intended uses in residential

scenarios. There are, therefore, no Food

Quality Protection Act covered nondietary exposures to RYH–86.

D. Cumulative Effects

There is no reliable information to

indicate that RYH–86 has a common

mechanism of toxicity with any other

chemical compound.

E. Safety Determination

1. U.S. population. Since the use of

RYH–86 as a slimicide in pulp and

paper mills is, under hypothetical worst

case conditions, anticipated to lead to

only negligible adult dietary exposures

(i.e., not greater than 0.63% of the RfD

for adults with ‘‘negligible’’ defined at

40 CFR 180.1(l) as ‘‘ordinarily’’ not

greater than 5% of the RfD) Yoshitomi

Fine Chemicals, Ltd. concludes that

there is a reasonable certainty that no

harm to the general adult population

will result from dietary exposure to

RYH–86 residues which could occur in

food contact paper and paperboard

produced in pulp and paper mills

utilizing RYH–86 for slime control in

accordance with its FIFRA labeling.

2. Infants and children. Since the use

of RYH–86 as a slimicide in pulp and

paper mills is, under hypothetical worst

case conditions, anticipated to lead to

only negligible dietary exposures (i.e.,

not greater than 1.71% of the RfD for

infants and not greater than 1.24% of

the RfD for children with ‘‘negligible’’

defined at 40 CFR 180.1(l) as

‘‘ordinarily’’ not greater than 5% of the

RfD) Yoshitomi Fine Chemicals, Ltd.

concludes that there is a reasonable

certainty that no harm to infants and

children will result from dietary

exposure to RYH–86 residues which

could occur in food contact paper and

paperboard produced in pulp and paper

mills utilizing RYH–86 for slime control

in accordance with its FIFRA labeling.

3. Sensitive individuals. The RfD for

RYH–86 is based on gastro-intestinal

irritation as the effect which occurs at

lowest dose in animal gavage studies.

Since the effect of irritation is a physicochemical effect, the existence of

metabolic differences among persons is

not reasonably expected to be a factor

producing individuals with special

sensitivity to RYH–86. Also, since: (a)

physico-chemical effects like irritancy

usually do not at all occur well below

a threshold concentration of irritant;

and, (b) the RfD is based on gavage

studies in which RYH–86 is directly

delivered to the gastric compartment

whereas daily dietary consumption of

the RfD amount leads to a lower peak

GI tract level than would occur after

gavage administration of the RfD

amount, it can be expected that even for

persons with pre-existing conditions

such as ulcers, colitis, and similar

pathologies that dietary exposures to

RYH–86 at levels up to the proposed

RfD will not exacerbate such conditions.

Therefore, Yoshitomi Fine Chemicals,

Ltd. concludes that there is a reasonable

certainty that no harm to persons with

pre-existing GI-tract problems will

result from dietary exposure to RYH–86

residues which could occur in food

contact paper and paperboard produced

in pulp and paper mills utilizing RYH–

86 for slime control in accordance with

its FIFRA labeling.

F. International Tolerances

There are no Codex maximum residue

levels (MRLs) established for residues of

RYH–86 resulting from the use of RYH–

86.

[FR Doc. 97–25338 Filed 9–23–97; 8:45 am]

BILLING CODE 6560–50–F

FEDERAL COMMUNICATIONS

COMMISSION

[Report No. 2225]

Petitions for Reconsideration and

Clarification of Action in Rulemaking

Proceedings

September 19, 1997.

Petitions for reconsideration and

clarification have been filed in the

Commission’s rulemaking proceedings

listed in this Public Notice and

published pursuant to 47 CFR Section

1.429(e). The full text of these

documents are available for viewing and

copying in Room 239, 1919 M Street,

N.W., Washington, D.C. or may be

purchased from the Commission’s copy

contractor, ITS, Inc. (202) 857–3800.

Oppositions to these petitions must be

filed October 9, 1997. See Section

1.4(b)(1) of the Commission’s rule (47

CFR 1.4(b)(1)). Replies to an opposition

must be filed within 10 days after the

time for filing oppositions has expired.

Subject: Amendment of Part 90 of the

Commission’s Rules to Facilitate Future

Development of SMR Systems in the

800 MHz Frequency Band (PR Docket

No. 93–144, RMs–8117,8030,8029).

Implementation of Sections 3(n) and

322 of the Communications Act

Regulatory Treatment of Mobile

Services (GN Docket No. 93–252).

Implementation of Section 309(j) of

the Communications Act—Competitive

Bidding (PP Docket No. 93–253).

Number of Petitions Filed: 6.

Subject: Amendment of Part 90 of the

Commission’s Rules to Facilitate Future

Development of SMR Systems in the

800 MHz Frequency Band (PR Docket

No. 93–144, RMs–8117,8030,8029).

Implementation of Sections 3(n) and

322 of the Communications Act

Regulatory Treatment of Mobile

Services (GN Docket No. 93–252).

Implementation of Section 309(j) of

the Communications Act—Competitive

Bidding (PP Docket No. 93–253).

Number of Petitions Filed: 3.