24788 Federal Register / Vol. 60, No. 90 / Wednesday, May 10, 1995 / Rules and Regulations

or raising tolerance levels or

establishing exemptions from tolerance

requirements do not have a significant

economic impact on a substantial

number of small entities. A certification

statement to this effect was published in

the Federal Register of May 4, 1981 (46

FR 24950).

The Office of Management and Budget

has exempted this rule from the

requirements of Section 3 of Executive

Order 12866.

Pursuant to the requirements of the

Regulatory Flexibility Act (Pub. L. 96-

534, 94 Stat. 1164, 5 U.S.C. 601-612),

the Administrator has determined that

regulations establishing new tolerances,

or raising tolerance levels, or

establishing exemptions from tolerance

requirements do not have a significant

economic impact on a substantial

number of small entities. A certification

statement to this effect was published in

the Federal Register of May 4, 1981 (46

FR 24950). (Sec. 408(d)(2), 68 Stat. 512

(21 U.S.C. 346a(d)(2)).)

List of Subjects in 40 CFR Part 180

Environmental protection,

Administrative practice and procedure,

Agricultural commodities, Pesticides

and pests, Reporting and recordkeeping

requirements.

Dated: May 5, 1995.

Stephen L. Johnson,

Director, Registration Division, Office of

Pesticide Programs.

Therefore, 40 CFR part 180 is

amended as follows:

1. The authority citation for part 180

continues to read as follows:

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

2. Section 180.377 is amended in

paragraph (a) in the table therein by

adding and alphabetically inserting

entries for the commodities orange,

grapefruit, and tangerine, to read as

follows:

§ 180.377 Diflubenzuron; tolerances for

residues.

(a) * * *

Commodity Parts per

million

* * * * *

Grapefruit .................................. 0.5

* * * * *

Orange ...................................... 0.5

* * * * *

Tangerine .................................. 0.5

* * * * *

* * * * * *

[FR Doc. 95–11495 Filed 5–5–95; 2:12 pm]

BILLING CODE 6560–50–F

40 CFR Part 180

[PP 4F4336/R2133; FRL–4953–8]

RIN 2070–AB78

Pesticide Tolerances for Prosulfuron

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Final rule.

SUMMARY: This rule establishes timelimited tolerances, to expire on

December 31, 1995, for residues of the

herbicide prosulfuron, 1-(4-methoxy-6-

methyl-triazin-2-yl)-3-[2-(3,3,3-

trifluoropropyl)-phenylsulfonyl]-urea,

in or on the raw agricultural

commodities corn (fodder, forage, grain

and fresh [including sweet kernels plus

cobs with husks removed]) at 0.01 part

per million (ppm), milk at 0.01 part per

million (ppm), and fat, kidney, liver,

meat, and meat byproducts of cattle,

goats, hogs, horses, and sheep at 0.05

part per million (ppm). Ciba-Geigy Corp.

requested this regulation pursuant to the

Federal Food, Drug and Cosmetic Act

(FFDCA). The regulation establishes

maximum permissible levels for

residues of the herbicide in or on the

commodities.

EFFECTIVE DATE: This regulation

becomes effective May 10, 1995.

ADDRESSES:Written objections and

hearing requests, identified by the

document control number, [PP 4F4336/

R2133] maybe submitted to the Hearing

Clerk (1900), Environmental Protection

Agency, Rm. M3708, 401 M St., SW.,

Washington, DC 20460. Fees

accompanying objections shall be

labeled ‘‘Tolerance Petition Fees’’ and

forwarded to: EPA Headquarters

Accounting Operations Branch, OPP

(Tolerance Fees), P.O. Box 36277M,

Pittsburgh, PA 15251. A copy of

objections and hearing request filed

with the Hearing Clerk should be

identified by the document 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 requests for

hearings filed with the Hearing Clerk

may also be submitted electronically by

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

requests for hearings must be submitted

as an ASCII file avoiding the use of

special characters and any form of

encryption. Copies of objections and

requests for hearings will also be

accepted on disks in WordPerfect in 5.1

file format or ASCII file format. All

copies of objections and requests for

hearings in electronic form must be

identified by the docket number [PP

4F4336/R2133]. No Confidential

Business Information (CBI) should be

submitted through e-mail. Electronic

copies of objections and requests for

hearings on this rule may be filed online

at many Federal Depository Libraries.

Additional information on electronic

submissions can be found below in this

document.

FOR FURTHER INFORMATION CONTACT: By

mail: Robert J. Taylor, Product Manager

(PM) 25, Registration Division

(H7505C), Environmental Protection

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

DC 20460. Office location and telephone

number: Rm. 245, CM #2, 1921 Jefferson

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

305-6800; e-mail:

taylor.robert@epamail.epa.gov.

SUPPLEMENTARY INFORMATION: EPA

issued a notice, published in the

Federal Register of November 2, 1994

(59 FR 54907), which announced that

the Ciba-Geigy Corp., P.O. Box 18300,

Greensboro, NC 27419-8300, had

submitted a pesticide petition, PP

4F4336, to EPA proposing to amend 40

CFR part 180 by establishing a tolerance

under section 408 of the Federal Food,

Drug and Cosmetic Act, 21 U.S.C. 346a,

for the residues the herbicide

prosulfuron, 1-(4-methoxy-6-methyltriazin-2-yl)-3-[2-(3,3,3-trifluoropropyl)-

phenylsulfonyl]-urea, in or on corn,

forage at 0.02 ppm; corn, fodder at 0.02

ppm; corn, grain at 0.02 ppm; corn,

fresh (including sweet kernels plus cobs

with husks removed) at 0.02 ppm; milk

at 0.02 ppm; meat byproducts, kidney

and liver of cattle, goats, hogs, horses,

and sheep at 0.10 ppm; poultry, fat,

kidney, liver, meat and meat byproducts

at 0.10 ppm; and eggs at 0.10 ppm.

The petitioner subsequently amended

the petition by lowering the tolerances

and withdrawing poultry from the list of

proposed tolerances. A notice was not

filed since there is less risk to man and

the environment.

There were no comments or requests

for referral to an advisory committee

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
Federal Register / Vol. 60, No. 90 / Wednesday, May 10, 1995 / Rules and Regulations 24789

below were considered in support of

this tolerance.

1. Several acute toxicology studies

placing technical-grade prosulfuron in

Toxicity Category III, and an acute

neurotoxicity study in rats at dose levels

of 0, 10, 250, 500, or 1,000 mg/kg with

an NOEL of 10 mg/kg based on reduced

motor activity and body temperature in

males and impaired righting reflex in

females. A 90-day neurotoxicity study

in rats demonstrated NOELs of greater

than 5,000 ppm in females and 10,000

ppm in males.

2. A 1-year feeding study with dogs

fed dosages of 0, 0.33, 1.95, 18.6, or 41.0

mg/kg/day (males) and 0, 0.31, 1.84,

20.2, or 48.8 mg/kg/day (females). The

NOEL was 1.84 mg/kg/day based on

hematologic and clinical chemistry

effects and incidence of lipofuscin

accumulation in the liver at 18.6 mg/kg/

day.

3. An 18-month carcinogenicity study

in mice fed dosages of 0, 1.71, 81.4, 410

or 832 mg/kg/day (males), and 0, 2.11,

100, 508 or 1,062 mg/kg/day (females).

There was no evidence of carcinogenic

effects up to 1,062 mg/kg/day, the

highest dose tested (HDT).

4. A 2-year chronic feeding/

carcinogenicity study in rats fed dosages

of 0, 0.4, 7.9, 79.9 or 160.9 (males), and

0, 0.5, 9.2, 95.7 or 205.8 mg/kg/day

(females). There was uncertain evidence

of carcinogenicity with slight increases

in the incidence of mammary gland

adenocarcinomas in females at 95.7 and

205.8 mg/kg/day, slight increase in

incidence of benign testicular interstital

cell tumors at 79.9 and 160.9 mg/kg/day

(significant trend only). A systemic

NOEL of 7.9 mg/kg/day was based on

decreased body weight and body weight

gain, hematopoietic effects (males), and

possibly increased serum GGT and

decreased liver, kidney and adrenal

weights (females) at 79.9 mg/kg/day.

5. A three-generation reproduction

study with rats fed dosages of 0, 0.67,

13.3, 136, or 278 (males), and 0, 0.76,

15.3, 152 or 311 mg/kg/day (females)

with a reproductive and a systemic

NOEL of 13.3 mg/kg/day based on

decreased mean body weights and body

weight gain observed at 136 mg/kg/day

for both pups and parental animals.

6. A developmental toxicity study in

rats at dose levels of 0, 5, 50, 200 and

400 mg/kg/day by gavage. The

developmental NOEL was 200 mg/kg/

day based on a statistically significant

elevation of combined skeletal findings

at 400 mg/kg/day, and maternal toxicity

NOEL of 200 mg/kg/day, based on

marginal effects on body weight gain at

400 mg/kg/day.

7. A developmental toxicity study in

rabbits at dose levels of 0, 1.0, 10 and

100 mg/kg/day by gavage with no

indications of developmental toxixicy at

dose levels up to 100 mg/kg/day. The

registrant was required to submit

another study at higher doses to

establish the NOEL and LEL for

maternal and developmental toxicity. A

new study is being conducted, and this

deficiency is not considered sufficient

to affect registration.

8. Three acceptable mutagenicity

studies were reviewed for prosulfuron.

These include assays with Salmonella

typhimurium strains TA1535, TA1537,

TA98, and TA100 or E. coli WP2 uvrA

exposed in either the presence or

absence of mammalian metabolic

activation; unscheduled DNA synthesis

(UDS) in primary rat hepatocytes; and a

structural chromosomal aberration

micronucleus test in mice. All these

tests were negative for mutagenicity.

The prosulfuron Reference Dose (RfD)

was established at 0.02 mg/kg/day based

on the 1-year dog chronic feeding study

with an uncertainty factor of 100. The

theoretical maximum residue

contribution (TMRC) for tolerances on

corn grain, straw and forage, and milk,

meat and meat byproducts utilizes 1.4%

of the RfD for the total U.S. population.

The most highly exposed subgroups,

children (ages 1 to 6) and nonnursing

infants (less than 1-year old), utilize

4.3% of the RfD.

The HED RfD/Peer Review Committee

classified this chemical as a Class D

oncogen based on the conclusion that

there was uncertain evidence of

carcinogenicity with slight increases in

the incidence of mammary gland

adenocarcinomas in female rats at 95.7

and 205.8 mg/kg/day, but significant

only at 95.7 mg/ kg/day, a slight

increase in incidence of benign

testicular interstital cell tumors in rats

at 79.9 and 160.9 mg/kg/day, and no

evidence in carcinogenicity in mice.

The committee also decided that

prosulfuron was not associated with any

significant reproductive or

develpmental toxicity under the

conditions of testing.

This pesticide is useful for the

purposes for which the tolerances are

sought. The nature of the residues is

adequately understood for the purposes

of establishing these tolerances. An

analytical method, HPLC with column

switching, is available for determination

of residues of prosulfuron in corn and

has been validated by an independent

laboratory. The field residue and radiolabeled field metabolism studies

submitted to the Agency indicate that

there are no residues in corn grain,

forage or fodder following application of

prosulfuron. In addition, as noted

above, the TMRC for the most highly

exposed subgroups utilizes only 4.3% of

the RFD. Therefore, this time limited

tolerance is being issued prior to the

completion of the method validation

process by the EPA laboratory. Because

of this, the Agency has set an expiration

date of December 31, 1995 for the

tolerance. Adequate analytical

methodology, HPLC with UV detection,

for animal tissues is available for

enforcement purposes. 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 Program

Resources 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 Hwy., Arlington, VA

22202.

Required data include a repeat of the

developmental study in rabbits, the

submission of stability data (storage and

chemical), information on accuracy of

the method used to verify the certified

limits, experimental details of all

solubility determinations, additional

corn and ruminant metabolism data,

and completion of method trial.

There are currently no actions

pending against the registration of this

chemical. Any secondary residues

occurring in meat, milk, and meat

byproducts will be covered by the

proposed tolerances in these

commodities. Based on the data and

information submitted above, the

Agency has determined that the

establishment of tolerances by

amending 40 CFR part 180 will protect

the public health. Therefore, EPA is

establishing the tolerances as described

below.

Any person adversely affected by this

regulation may, within 30 days after the

date of publication in the Federal

Register, file written objections with the

Hearing Clerk, Environmental

Protection Agency, 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
24790 Federal Register / Vol. 60, No. 90 / Wednesday, May 10, 1995 / Rules and Regulations

requestor’s contentions on each issue,

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.

A record has been established for this

rulemaking under docket number [PP

4F4336/R2133] (including objections

and hearing requests 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 a.m. to 4:30 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

Operations Division (7506C), Office of

Pesticide Programs, Environmental

Protection Agency, Crystal Mall #2,

1921 Jefferson Davis Highway,

Arlington, VA.

Written objections and requests for

hearings, identified by the document

control number [PP 4F4336/R2133],

may be submitted to the Hearing Clerk

(1900), Environmental Protection

Agency, Rm. 3708, 401 M St., SW.,

Washington, DC 20460.

A copy of electronic objections and

requests for hearings filed with the

Hearing Clerk can be sent directly to

EPA at:

opp-Docket@epamail.epa.gov

A copy of electronic objections and

requests for hearings filed with the

Hearing Clerk must be submitted as an

ASCII file avoiding the use of special

characters and any form of encryption.

The official record for this

rulemaking, as well as the public

version, as described above will be kept

in paper form. Accordingly, EPA will

transfer any objections and hearing

requests received electronically into

printed, paper form as they are received

and will place the paper copies in the

official rulemaking record which will

also include all objections and hearing

requests submitted directly in writing.

The official rulemaking record is the

paper record maintained at the address

in ADDRESSES at the beginning of this

document.

Under Executive Order 12866 (58 FR

51735, Oct. 4, 1993) the Agency must

determine whether the regulatory action

is ‘‘significant’’ and therefore subject to

review by the Office of Management and

Budget (OMB) and the requirements of

the Executive Order. Under section 3(f),

the order defies a ‘‘signficant regulatory

action’’ as an action that is likely to

result in a rule (1) having an annual

effect on the economy of $100 million

or more, or adversely and materially

affecting a sector of the economy,

productivity, competition, jobs, the

environment, public health or safety, or

State, local, or tribal governments or

communities (also referred to as

‘‘economically significant’’); (2) creating

serious inconsistancy or otherwise

interfering with an action taken or

planned by another Agency; (3)

materially altering the budgetary

impacts of entitlement, grants, user fees,

or loan programs or the rights and

obligations of recipients thereof; or (4)

raising novel legal or policy issues

arising out of legal mandates, the

President’s priorities, or the principles

set forth in this Executive Order.

Pursuant to the terms of the Executive

Order, EPA has determined that this

rule is not ‘‘significant’’ and is therefore

not subject to OMB review. Pursuant to

the requirements of the Regulatory

Flexibility Act (Pub. L. 96-354, 94 Stat.

1164, 5 U.S.C. 601-612), the

Administrator has determined that

regulations establishing new tolerances

or raising tolerance levels or

establishing exemptions from tolerance

requirements do not have a significant

economic impact on a substantial

number of small entities. A certification

statement to this effect was published in

the Federal Register of May 4, 1981(46

FR 24950).

List of Subjects in 40 CFR Part 180

Environmental protection,

Administrative practice and procedure,

Agricultural commodities, Pesticides

and pests, Reporting and recordkeeping

requirements.

Dated: May 3, 1995.

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 new § 180.481, to read as

follows:

§ 180.481 Prosulfuron; tolerances for

residues.

Time-limited tolerances, to expire on

December 31, 1995, are established for

residues of the herbicide prosulfuron, 1-

(4-methoxy-6-methyl-triazin-2-yl)-3-[2-

(3,3,3-trifluoropyl)-phenyl-sulfonyl]-

urea, in or on the following raw

agricultural commodities:

Commodity

Parts

per million

Expiration

date

Cattle, fat .............. 0.05 Dec. 31,

1995.

Cattle, kidney ........ 0.05 Do.

Cattle, liver ............ 0.05 Do.

Cattle, meat .......... 0.05 Do.

Cattle, mbyp .......... 0.05 Do.

Corn, fodder .......... 0.01 Do.

Corn, forage .......... 0.01 Do.

Corn, grain and

fresh (including

sweet kernels

plus cobs with

husks removed).

0.01 Do.

Goats, fat .............. 0.05 Do.

Goats, kidney ........ 0.05 Do.

Goats, liver ............ 0.05 Do.

Goats, meat .......... 0.05 Do.

Goats, mbyp ......... 0.05 Do.

Hogs, fat ............... 0.05 Do.

Hogs, kidney ......... 0.05 Do.

Hogs, liver ............. 0.05 Do.

Hogs, meat ........... 0.05 Do.

Hogs, mbyp ........... 0.05 Do.

Horses, fat ............ 0.05 Do.

Horses, kidney ...... 0.05 Do.

Horses, liver .......... 0.05 Do.

Horses, meat ........ 0.05 Do.

Horses, mbyp ........ 0.05 Do.

Milk ........................ 0.01 Do.

Sheep, fat ............. 0.05 Do.

Sheep, kidney ....... 0.05 Do.

Sheep, liver ........... 0.05 Do.

Sheep, meat ......... 0.05 Do.

Sheep, mbyp ......... 0.05 Do.

[FR Doc. 95–11667 Filed 5–8–95; 1:34 pm]

BILLING CODE 6560–50–F

40 CFR Part 271

[FRL–5204–5]

Georgia; Final Authorization of

Revisions to State Hazardous Waste

Management Program

AGENCY: Environmental Protection

Agency.

ACTION: Immediate final rule.

SUMMARY: Georgia has applied for final

authorization of revisions to its

hazardous waste program under the

Resource Conservation and Recovery

Act (RCRA). Georgia’s revisions consist

of the provisions contained in rules

promulgated between July 1, 1992, and

June 30, 1993, otherwise known as