Federal Register / Vol. 60, No. 244 / Wednesday, December 20, 1995 / Rules and Regulations 65575

average is greater or lesser than the

applicable standard;

(H) The applicable T90 distillation

point standard under § 80.41(h)(2)(i) in

degrees Fahrenheit;

(I) The average T90 distillation point

in degrees Fahrenheit; and

(J) The difference between the

applicable T90 distillation point

standard under § 80.41(h)(2)(i) in

degrees Fahrenheit and the average T90

distillation point under paragraph

(b)(2)(ii)(I) of this section in degrees

Fahrenheit, indicating whether the

average is greater or lesser than the

applicable standard.

* * * * *

3. Section 80.93 is amended by

revising paragraph (b)(6) to read as

follows:

§ 80.93 Individual baseline submission

and approval.

* * * * *

(b) * * *

(6) Confidential business information.

(i) Upon approval of an individual

baseline, EPA will publish the

individual annualized baseline exhaust

emissions, on an annual average basis,

specified in paragraph (b)(5)(ii) of this

section. Such individual baseline

exhaust emissions shall not be

considered confidential. In addition, the

reporting information required under

§ 80.75(b)(2)(ii) (D), (G) and (J), and

§ 80.105(a)(4)(i) (E), (H) and (K) shall not

be considered confidential.

(ii) Information in the baseline

submission which the submitter desires

to be considered confidential business

information (per 40 CFR part 2, subpart

B) must be clearly identified. If no claim

of confidentiality accompanies a

submission when it is received by EPA,

the information may be made available

to the public without further notice to

the submitter pursuant to the provisions

of 40 CFR part 2, subpart B.

* * * * *

4. Section 80.105 is amended by

revising paragraph (a)(4) to read as

follows:

§ 80.105 Reporting requirements.

(a) * * *

(4)(i) If using the simple model:

(A) The applicable exhaust benzene

emissions standard under

§ 80.101(b)(1)(i);

(B) The average exhaust benzene

emissions under § 80.101(g);

(C) The applicable sulfur content

standard under § 80.101(b)(1)(ii) in parts

per million;

(D) The average sulfur content under

§ 80.101(g) in parts per million;

(E) The difference between the

applicable sulfur content standard

under § 80.101(b)(1)(ii) in parts per

million and the average sulfur content

under paragraph (a)(4)(i)(D) of this

section in parts per million, indicating

whether the average is greater or lesser

than the applicable standard;

(F) The applicable olefin content

standard under § 80.101(b)(1)(iii) in

volume percent;

(G) The average olefin content under

§ 80.101(g) in volume percent;

(H) The difference between the

applicable olefin content standard

under § 80.101(b)(1)(iii) in volume

percent and the average olefin content

under paragraph (a)(4)(i)(G) of this

section in volume percent, indicating

whether the average is greater or lesser

than the applicable standard;

(I) The applicable T90 distillation

point standard under § 80.101(b)(1)(iv)

in degrees Fahrenheit;

(J) The average T90 distillation point

under § 80.101(g) in degrees Fahrenheit;

and

(K) The difference between the

applicable T90 distillation point

standard under § 80.101(b)(1)(iv) in

degrees Fahrenheit and the average T90

distillation point under paragraph

(a)(4)(i)(J) of this section in degrees

Fahrenheit, indicating whether the

average is greater or lesser than the

applicable standard.

(ii) If using the optional complex

model, the applicable exhaust benzene

emissions standard and the average

exhaust benzene emissions, under

§ 80.101(b)(2) and (g).

(iii) If using the complex model:

(A) The applicable exhaust toxics

emissions standard and the average

exhaust toxics emissions, under

§ 80.101(b)(3) and (g); and

(B) The applicable NOX emissions

standard and the average NOX

emissions, under § 80.101(b)(3) and (g).

* * * * *

[FR Doc. 95–30986 Filed 12–19–95; 8:45 am]

BILLING CODE 6560–50–P

40 CFR Part 180

[PP 6F3417 and 7F3516/R2192; FRL–4990–

7]

RIN 2070–AB78

Thiodicarb; Extension of Pesticide

Tolerances

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Final rule.

SUMMARY: This rule extends until

August 15, 1997, the temporary

tolerances for the insecticide thiodicarb

and its metabolite in or on leafy

vegetables, broccoli, cabbage, and

cauliflower. Rhone Poulenc Ag. Co.

requested this regulation pursuant to the

Federal Food, Drug and Cosmetic Act

(FFDCA).

EFFECTIVE DATE: This regulation

becomes effective December 20, 1995.

ADDRESSES: Written objections and

hearing requests, identified by the

document control number, [PP 6F3417

and 7F3516/R2192], may be submitted

to: Hearing Clerk (1900), Environmental

Protection Agency, Rm. M3708, 401 M

St., SW., Washington, DC 20460. A copy

of any objections and hearing requests

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. Fees accompanying

objections 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 objections and hearing

requests filed with the Hearing Clerk

may also be submitted electronically by

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

objections and hearing requests must be

submitted as an ASCII file avoiding the

use of special characters and any form

of encryption. Copies of objections and

hearing requests will also be accepted

on disks in WordPerfect in 5.1 file

format or ASCII file format. All copies

of objections and hearing requests in

electronic form must be identified by

the docket number [PP 6F3417 and

7F3516/R2192]. No Confidential

Business Information (CBI) should be

submitted through e-mail. Electronic

copies of objections and hearing

requests on this rule may be filed online

at many Federal Depository Libraries.

Additional information on electronic

submissions can be found below in this

document.

FOR FURTHER INFORMATION CONTACT: By

mail: Dennis Edwards, Jr., Product

Manager (PM 19), Registration Division

(7505C), Office of Pesticide Programs,

Environmental Protection Agency, 401

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

Office location and telephone number:

Rm. 213, CM #2, 1921 Jefferson Davis

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

6386; e-mail:

edwards.dennis@epamail.epa.gov.
65576 Federal Register / Vol. 60, No. 244 / Wednesday, December 20, 1995 / Rules and Regulations

SUPPLEMENTARY INFORMATION: Pursuant

to petitions from the Rhone Poulenc Ag.

Co., P.O. Box 12014, Research Triangle

Park, NC 27709, EPA issued final rules

establishing temporary tolerances for

residues of the combined residues of the

insecticide thiodicarb in or on leafy

vegetables at 35 parts per million (ppm)

and broccoli, cabbage, and cauliflower

at 7 ppm (see the Federal Register of

August 11, 1993 (58 FR 42673)). To be

consistent with conditional registrations

for thiodicarb on leafy vegetables and

broccoli, cabbage, and cauliflower,

which were due to expire December 31,

1995, the Agency established the

tolerances with an expiration date of

August 15, 1996, to cover residues

expected to be present from use during

the period of conditional registration

while the Agency continued to review

studies of acetamide, a metabolite, and

the chronic carcinogenicity studies for

thiodicarb. The Agency concluded that

the human risk posed by the use of

thiodicarb on leafy vegetables and

broccoli, cabbage, and cauliflower does

not raise significant concerns and that

extending the tolerances would still be

protective of human health. The Agency

is continuing to review submitted

toxicology studies.

In a notice in the Federal Register of

October 25, 1995 (60 FR 54690), the

Agency announced the receipt of a

request from Rhone Poulenc Ag. Co. to

extend the temporary tolerances for

thiodicarb and its metabolite for leafy

vegetables, broccoli, cabbage, and

cauliflower for 1 year with an expiration

date of August 15, 1997. No comments

were received as a result of the notice.

Therefore, as set forth below, the

temporary tolerances are extended for

an additional year with an expiration

date of August 15, 1997, to cover

residues existing from the continued

conditional registration of thiodicarb.

The tolerances could be made

permanent if full registration is

subsequently granted. Notice of further

action on these tolerances will be

published for comment in the Federal

Register. Residues remaining in or on

the above raw agricultural commodities

after expiration of the tolerances will

not be considered actionable if the

pesticide is legally applied during the

term of, and in accordance with,

provisions of the conditional

registrations.

Any person adversely affected by this

regulation may, within 30 days after

publication of this document in the

Federal Register, file written objections

to the regulation and may also request

a hearing on those objections.

Objections and hearing requests must be

filed with the Hearing Clerk, at the

address given above (40 CFR 178.20). A

copy of the objections and/or hearing

requests filed with the Hearing Clerk

should be submitted to the OPP docket

for this rulemaking. The objections

submitted must specify the provisions

of the regulation deemed objectionable

and the grounds for the objections (40

CFR 178.25). Each objection must be

accompanied by the fee prescribed by

40 CFR 180.33(i). If a hearing is

requested, the objections must include a

statement of the factual issue(s) on

which a hearing is requested, the

requestor’s contentions on such issues,

and a summary of any evidence relied

upon by the objector (40 CFR 178.27). A

request for a hearing will be granted if

the Administrator determines that the

material submitted shows the following:

There is 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

6F3417 and 7F3516/R2192] (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 Room 1132 of the

Public Response and Program Resources

Branch, Field Operations Division

(7506C), Office of Pesticide Programs,

Environmental Protection Agency,

Crystal Mall #2, 1921 Jefferson Davis

Highway, Arlington, VA.

Written objections and hearing

requests, identified by the document

control number [PP 6F3417 and 7F3516/

R2192], 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

hearing requests filed with the Hearing

Clerk can be sent directly to EPA at:

opp-Docket@epamail.epa.gov

A copy of electronic objections and

hearing requests 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, October 4, 1993), the Agency

must determine whether the regulatory

action is ‘‘significant’’ and therefore

subject to all the requirements of the

Executive Order (i.e., Regulatory Impact

Analysis, review by the Office of

Management and Budget (OMB)). Under

section 3(f), the order defines

‘‘significant’’ as those actions likely to

lead to 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 known as

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

serious inconsistency 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 (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 this

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.
Federal Register / Vol. 60, No. 244 / Wednesday, December 20, 1995 / Rules and Regulations 65577

Dated: December 5, 1995.

Stephen L. Johnson,

Director, Registration Division, 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.

§ 180.407 [Amended]

2. Section 180.407 Thiodicarb;

tolerances for residues is amended in

paragraph (b) introductory text by

changing ‘‘August 15, 1996’’ to read

‘‘August 15, 1997’’, and in paragraph (c)

introductory text by changing ‘‘August

15, 1996’’ to read ‘‘August 15, 1997’’.

[FR Doc. 95–30974 Filed 12–19–95; 8:45 am]

BILLING CODE 6560–50–F

40 CFR Part 180

[PP 9F3787/R2194; FRL–4991–1]

RIN 2070–AB78

Avermectin B1 and Its Delta-8,9-

Isomer; Pesticide Tolerance

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Final rule.

SUMMARY: This document establishes a

tolerance for combined residues of the

insecticide avermectin B1 and its delta8,9-isomer in or on the raw agricultural

commodity pears. Merck Research

Laboratories requested this regulation to

establish a maximum permissible level

for residues of the insecticide pursuant

to the Federal Food, Drug and Cosmetic

Act (FFDCA).

EFFECTIVE DATE: This regulation

becomes effective December 20, 1995.

ADDRESSES: Written objections and

hearing requests, identified by the

document control number [PP 9F3787/

R2194], may be submitted to: Hearing

Clerk (1900), Environmental Protection

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

Washington, DC 20460. A copy of any

objections and hearing requests 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. Fees accompanying

objections 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 objections and hearing

requests filed with the Hearing Clerk

may also be submitted electronically by

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

objections and hearing requests must be

submitted as an ASCII file avoiding the

use of special characters and any form

of encryption. Copies of objections and

hearing requests will also be accepted

on disks in WordPerfect in 5.1 file

format or ASCII file format. All copies

of objections and hearing requests in

electronic form must be identified by

the docket number [PP 9F3787/R2194].

No Confidential Business Information

(CBI) should be submitted through email. Electronic copies of objections and

hearing requests on this rule may be

filed online at many Federal Depository

Libraries. Additional information on

electronic submissions can be found

below in this document.

FOR FURTHER INFORMATION CONTACT: By

mail: George LaRocca, Product Manager

(PM) 13, Registration Division (7505C),

Office of Pesticide Programs,

Environmental Protection Agency, 401

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

Office location and telephone number:

Rm. 204, CM #2, 1921 Jefferson Davis

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

6100; e-mail:

larocca.george.@epamail.epa.gov.

SUPPLEMENTARY INFORMATION: EPA

issued a notice, published in the

Federal Register of November 1, 1989

(54 FR 46118), which announced that

Merck Research Laboratories, Inc.,

Hillsborough Rd., Three Bridges, NJ

98887, had submitted a pesticide

petition (PP 9F3787) to EPA requesting

that the Administrator, pursuant to

section 408(d) of the Federal Food, Drug

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

346a(d), establish a tolerance for

combined residues of the insecticide

avermectin B1 and its delta-8,9-isomer

in or on the raw agricultural commodity

(RAC) pears at 0.035 part per million

(ppm). In a letter dated September 22,

1993, Merck requested that the pesticide

petition be amended by proposing a

lower tolerance on pears at 0.02 ppm.

No comments were received in response

to the notice of filing (See 58 FR 64583;

Dec. 8, 1993).

The data submitted in support of this

tolerance and other relevant material

have been reviewed. The toxicological

and metabolism data considered in

support of this tolerance are discussed

in detail in related documents

published in the Federal Register of

May 31, 1989 (54 FR 23209, cottonseed)

and August 2, 1989 (54 FR 31836,

citrus). The Agency used a twogeneration rat reproduction study with

an uncertainty factor of 300 to establish

a Reference Dose (RfD). The 300-fold

uncertainty factor was utilized for (1)

inter- and intra-species differences, (2)

the extremely serious nature (pup death)

observed in the reproduction study, (3)

maternal toxicity (lethality) noobservable-effect level (NOEL) (0.05 mg/

kg/day), and (4) cleft palate in the

mouse developmental toxicity study

with isomer (NOEL = 0.06 mg/kg/day).

Thus, based on a NOEL of 0.12 mg/kg/

day from the two-generation rat

reproduction and an uncertainty factor

of 300, the RfD is 0.0004 mg/kg/body

weight(bwt)/day.

A chronic dietary exposure/risk

assessment has been performed for

avermectin B1 using the above RfD.

Available information on anticipated

residues and 100% crop treated was

incorporated into the analysis to

estimate the Anticipated Residue

Contribution (ARC). The ARC is

generally considered a more realistic

estimate than an estimate based on the

tolerance level residues. The ARC for

established tolerances and the current

action is estimated at 0.000013 mg/kg/

bwt/day and utilizes 3.4 percent of the

RfD for the U.S. population. For

nonnursing infants less than 1-year old

(the sub-group population with the

highest exposure level) the ARC for

established tolerances and the current

action is estimated at 0.000030 mg/kg

bwt/day and utilizes 7.5% of the RfD.

Generally speaking, the Agency has no

cause for concern if anticipated residues

contribution for all published and

proposed tolerances is less than the RfD.

Because of the developmental effects

seen in animal studies, the Agency used

the mouse teratology study (with a

NOEL of 0.06 mg/kg/day for

developmental toxicity for the delta-8,9

isomer) to assess acute dietary exposure

and determine a margin of exposure

(MOE) for the overall U.S. population

and certain subgroups. Since the

toxicological end point pertains to

developmental toxicity, the population

group of interest for this analysis is

women aged 13 and above, the subgroup

which most closely approximates

women of child-bearing ages. The MOE

is calculated as the ratio of the NOEL to

the exposure. For this analysis, the

Agency calculated the MOE for the

high-end exposures for women ages 13

and above. The MOE is 1,000. Generally

speaking, MOEs greater than 100 for