[Federal Register Volume 60, Number 75 (Wednesday, April 19, 1995)]
[Rules and Regulations]
[Pages 19523-19524]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-9165]



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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180

[PP 4F4334/R2114; FRL-4941-2]
RIN 2070-AB78


Poly-D-Glucosamine (Chitosan); Exemption from the Requirement of 
a Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This document establishes an exemption from the requirement of 
a tolerance for residues of the biochemical growth regulator poly-D-
glucosamine (hereafter referred to as chitosan) when used as a seed 
treatment in or on rice. 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. Vanson L.P. 
requested this exemption.

EFFECTIVE DATE: This regulation becomes effective April 19, 1995.
ADDRESSES: Written objections, identified by the document control 
number, [PP 4F4334/R2114], 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.

FOR FURTHER INFORMATION CONTACT: By mail: Joanne Miller, Product 
Manager (PM) 23, Registration Division (7505C), Environmental 
Protection Agency, 401 M St., SW., Washington, DC 20460. Office 
location and telephone number: Rm. 237, CM #2, 1921 Jefferson Davis 
Hwy., Arlington, VA 22202, (703)-305-7830; E-mail: 
[email protected].

SUPPLEMENTARY INFORMATION: In the Federal Register of November 2, 1994 
(59 FR 54907), EPA issued a notice that Vanson L.P., 8840, 152nd Ave., 
[[Page 19524]] 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:


Sec. 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]
BILLING CODE 6560-50-F