19524 Federal Register / Vol. 60, No. 75 / Wednesday, April 19, 1995 / Rules and Regulations

Northeast, Redmond, WA 98052, had

submitted pesticide petition (PP

4F4334) to EPA proposing that an

exemption from the requirement of a

tolerance be established for residues of

the biochemical growth regulator

chitosan when used as a seed treatment

on rice.

Chitosan is a naturally occurring

substance produced from chitin extracts

of crustacean shells (e.g., crab, shrimp,

and lobster). The product is intended for

use in treatment of seed prior to

planting. Plant root growth is stimulated

and stem strength enhanced, helping to

prevent lodging (when the plants fall

over because weak stems are unable to

support it) in rice. Plants which lodge

are difficult to harvest; therefore, yields

may be decreased.

The chemical is taken up by plant

cells where it enters the nucleus and

stimulates messenger RNA and enzyme

production. In the case of rice, such

enzymes are thought to be responsible

for stimulating the plant to produce

more lignin in the stems, resulting in

stronger stems and decreased lodging.

The Agency considered the following

factors in support of this request for

exemption from the requirement of a

tolerance: Chitosan (1) is not toxic, as

demonstrated in acute toxicity studies

in mice, rats, and rabbits; (2) is naturally

occurring in the environment in large

concentrations; (3) has been exempted

from the requirement of a tolerance in

or on barley, beans, oats, peas, and

wheat (40 CFR 180.1072) when used as

a seed treatment at an application rate

of 4 oz./100 lbs. seed; (4) has been

approved by the State of Oregon for use

in unrestricted amounts as a soil

amendment (fertilizer), a use not

regulated by EPA under the Federal

Insecticide, Fungicide, and Rodenticide

Act. Certain chitin-based products are

permitted to be used in foods as

hypocholesterolemic agents, as dietary

fiber in low-calorie diets, and as agents

to increase the specific loaf volume of

bread.

Acceptable daily intake (ADI) and

maximum permissible intake (MPI)

considerations are not relevant to this

exemption request. Therefore, the

requirement for an analytical method for

enforcement purposes is not applicable

to this exemption request.

Chitosan is considered useful for the

purpose for which the exemption from

the requirement of a tolerance is sought.

Based on the information considered,

the Agency concludes that

establishment of the exemption will

protect the public health. Therefore, the

regulation is established as set forth

below.

Based on the nontoxic nature of this

chemical, the Agency is also

establishing an exemption from the

requirement of a tolerance for residues

of poly-D-glucosamine when used as a

pesticide in the production of any raw

agricultural commodities.

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 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).

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 defines a ‘‘significant

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

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 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: April 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. Section 180.1072 is revised to read

as follows:

§ 180.1072 Poly-D-glucosamine (chitosan);

exemption from the requirement of a

tolerance.

(a) An exemption from the

requirement of a tolerance is established

for residues of the biological plant

growth regulator poly-D-glucosamine

when used as a seed treatment in or on

barley, beans, oats, peas, rice, and

wheat.

(b) An exemption from the

requirement of a tolerance is established

for residues of the biological plant

growth regulator poly-D-glucosamine

when used as a pesticide in the

production any raw agricultural

commodity.

[FR Doc. 95–9165 Filed 4–18–95; 8:45 am]

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