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
65578 Federal Register / Vol. 60, No. 244 / Wednesday, December 20, 1995 / Rules and Regulations

developmental toxicity do not raise

concerns.

The metabolism of the chemical in

plants and animals for the use is

adequately understood. Secondary

residues occurring in livestock and their

by-products are not expected since there

are no known animal feed stock uses for

pears. Adequate analytical methodology

(HPLC-Fluorescence Methods) is

available for enforcement purposes. The

enforcement methodology has been

submitted to the Food and Drug

Administration for publication in the

Pesticide Analytical Manual, Vol. II

(PAM II). Because of the long lead time

for publication of the method in PAM II,

the analytical methodology is being

made available in the interim to anyone

interested in pesticide enforcement

when requested from Calvin Furlow,

Public Response and Program Resource

Branch, Field Operations Division

(7506C), Office of Pesticide Programs,

U.S. Environmental Protection Agency,

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

Office location and telephone number:

Rm. 1132, CM #2, 1921 Jefferson Davis

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

5232.

The tolerances established by

amending 40 CFR part 180 will be

adequate to cover residues in or on

pears. There are currently no actions

pending against the continued

registration of this chemical. Based on

the information and data considered,

the Agency has determined that the

tolerance established by amending 40

CFR part 180 would protect the public

health. Therefore, it is proposed that the

tolerance be established as set forth

below.

Any person adversely affected by this

regulation may, within 30 days after

publication of this document in the

Federal Register, file written objections

and/or request a hearing 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 or

the requestor, taking into account

uncontested claims or facts to the

contrary; and resolution of the factual

issues(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

9F3787/R2194] (including comments

and data submitted electronically as

described below). A public version of

this record, including printed, paper

version 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, Crystall Mall #2,

1921 Jefferson Davis Highway,

Arlington, VA.

Electronic comments can be sent

directly to EPA at:

oop-Docket@epamail.epa.gov.

Electronic comments 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 all comments 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

comments 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

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.

Dated: December 7, 1995.

Stephen L. Johnson,

Director, Registration Division, Office of

Pesticide Programs.

Therefore, 40 CFR part 180 continues

to read as follows:

PART 180—[AMENDED]

1. The authority citation of part 180

continues to read as follows:

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

2. By amending § 180.449(b) in the

table therein by adding and

alphabetically inserting an entry for

pears, to read as follows:

§ 180.449 Avermectin B1 and its delta-8,9-

isomer; tolerances for residues.

* * * * *

(b) * * *

Commodity Parts per

million

* * * * *

Pears ......................................... 0.02

* * * * *

[FR Doc. 95–30975 Filed 12–19–95; 8:45 am]

BILLING CODE 6560–50–F