[Federal Register Volume 59, Number 41 (Wednesday, March 2, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-4645]


[[Page Unknown]]

[Federal Register: March 2, 1994]


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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180

[PP 0F3851/R2042; FRL-4759-7]
RIN 2070-AB78

 

Exemption From the Requirement of a Pesticide Tolerance for the 
Insect Pheromone Codlure

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: EPA is establishing an exemption from the requirement of a 
pesticide tolerance on all raw agricultural commodities for the insect 
pheromone codlure, [(E,E)-8,10-dodecadien-1-ol], in accordance with 
certain prescribed conditions. Consep Membranes, Inc., requested this 
tolerance exemption regulation.
EFFECTIVE DATE: Effective on March 2, 1994.

ADDRESSES: Written objections and hearing requests, identified by the 
document control number, [PP 0F3851/R2042], may be submitted to: 
Hearing Clerk, Environmental Protection Agency, Rm. 3708, 401 M St., 
SW., Washington, DC 20460. A copy of any objections and hearing 
requests filed with the Hearing Clerk should also be 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, deliver objections and 
hearing requests filed with the Hearing Clerk to: Rm. 1128, Crystal 
Mall #2, 1921 Jefferson Davis Hwy., Arlington, VA 22202. Fees 
accompanying objections shall be labeled ``Tolerance Petition Fees'' 
and forwarded to: Environmental Protection Agency, Headquarters 
Accounting Operations Branch, Office of Pesticide Programs (Tolerance 
Fees), P.O. Box 360277M, Pittsburgh, PA 15251.

FOR FURTHER INFORMATION CONTACT: Philip O. Hutton, Product Manager (PM) 
18, Registration Division (7505C), Office of Pesticide Programs, 
Environmental Protection Agency, Rm. 213, CM #2, 1921 Jefferson Davis 
Hwy., Arlington, VA 22202, (703)-305-7690.

SUPPLEMENTARY INFORMATION: In the Federal Register of June 29, 1990 (55 
FR 26752), EPA issued a notice which announced that Consep Membranes, 
Inc., of Bend, OR, had submitted a pesticide petition (PP OF3851) to 
EPA proposing to amend 40 CFR part 180 by establishing a regulation for 
exemption from the requirement of a tolerance (under section 408 of the 
Federal Food, Drug and Cosmetic Act, 21 U.S.C. 346(a)), for codlure, 
[(E,E)-8,10-dodecadien-1-ol], in or on all raw agricultural 
commodities.
    There were no comments or requests for referral to an advisory 
committee received in response to the notice of filing. The scientific 
data submitted in the petition and other relevant material have been 
evaluated.
    The mammalian toxicological data considered in support of the 
exemption from the requirement of a tolerance include an acute oral 
toxicity study in rats, an acute dermal toxicity study in rats, an 
acute intratracheal toxicity study in rats, a primary eye irritation 
study in rabbits, a primary dermal irritation study in rabbits, a 
dermal sensitization study in guinea pigs, and an Ames mutagenicity 
assay.
    The results of these studies showed no significant toxic effects. 
When male and female rats were dosed orally at 5,050 mg/kg, minor 
effects including piloerection, diarrhea, salivation, nasal discharge, 
epistaxis, and polyuria occurring immediately following dosing were 
observed. All symptoms disappeared within 3 days after dosing. 
(Toxicity Category IV). When male and female rats were dosed dermally 
at 2,020 mg/kg in a single application, one of the females showed 
decreased defecation and diarrhea, whereas males showed no effects. No 
deaths occurred and no gross pathological findings were reported for 
any animals (Toxicity Category III). Male and female rats exposed to 
2.5 mL/kg codlure via the intratracheal route gained weight during the 
course of the study. Only minor clinical signs of toxicity were 
observed, i.e., decreased activity, chromodacryorrhea, constricted 
pupils, epistaxis, nasal discharge, salivation, and respiratory gurgle. 
No deaths were reported and upon necropsy, no compound-related findings 
were observed (Toxicity Category III). The primary eye irritation study 
demonstrated resolution of conjunctival redness by day 7 and resolution 
of chemosis and conjunctival discharge by 72 hours in rabbits (Toxicity 
Category III). The primary dermal irritation study in rabbits resulted 
in primary dermal irritation scores of 2.5 (mildly irritating) and 3.3 
(moderately irritating) at 72 and 96 hours, respectively (Toxicity 
Category III). The dermal sensitization study (Buehler) indicated that 
the codlure pheromone is not a dermal sensitizer. The Ames mutagenicity 
assay indicated up to cytotoxic levels that in the presence or absence 
of S9 activation, codlure showed no evidence of mutagenic activity in 
Salmonella typhimurium.
    Reference Dose (RfD) and maximum permissible intake (MPI) 
considerations are not relevant to this petition because the data 
submitted demonstrate that this insect pheromone showed no significant 
adverse effect to laboratory animals in any test. Because no tolerance 
level is set for this insect pheromone, the requirement for an 
analytical method for enforcement purposes is not applicable to this 
exemption from the requirement of a tolerance.
    Based on the information cited above, the Agency has determined 
that the establishment of a tolerance is not necessary to protect the 
public health. Therefore, the permanent exemption from the requirement 
of a tolerance is established with the following conditions:
    a. Application shall be limited solely to codlure dispensers that 
conform to the following specifications:
    1. Commodity exposure must be limited to inadvertent physical 
contact. The design of the dispenser must be such as to preclude any 
exposure of its components to the raw agricultural commodity (RAC) or 
processed foods/feeds derived from the commodity due to its proximity 
to the RAC or as a result of its physical size. Dispensers must be of 
such size and construction that they are readily recognized post-
application.
    2. The dispensers must be applied discretely, i.e., placed in the 
field in easily perceived distinct locations in a manner that does not 
prevent later retrieval. This exemption does not apply to codlure 
applied in a broadcast manner either to a crop field plot or to 
individual plants.
    b. A codlure dispenser is a single-enclosed or semi-enclosed unit 
that releases codlure into the surrounding atmosphere via 
volatilization and is applied in a manner to provide discrete 
application, i.e., in easily perceived distinct locations in a manner 
that does not prevent later retrieval of the codlure into the 
environment.
    Any person adversely affected by this regulation may, within 30 
days after the date of publication of this document in the Federal 
Register, file written objections and/or a request for a hearing with 
the Hearing Clerk at the address given above. 40 CFR 178.20. A copy of 
the objections and hearing requests filed withthe Hearing Clerk should 
also be 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. 
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 each such 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.
    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 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: February 17, 1994.

Douglas D. Campt,
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 Sec. 180.1126 to subpart D, to read as follows:


Sec. 180.1126   Codlure, (E,E)-8,10-Dodecadien-1-ol; exemption from the 
requirement of a tolerance.

    An exemption from the requirement of a tolerance is established for 
the insect pheromone codlure, (E,E)-8,10-dodecadien-1-ol, on all raw 
agricultural commodities in accordance with the following prescribed 
conditions:
    (a) Application shall be limited solely to codlure dispensers that 
conform to the following specifications:
    (1) Commodity exposure must be limited to inadvertent physical 
contact. The design of the dispenser must be such as to preclude any 
exposure of its components to the raw agricultural commodity (RAC) or 
processed foods/feeds derived from the commodity due to its proximity 
to the RAC or as a result of its physical size. Dispensers must be of 
such size and construction that they are readily recognized post-
application.
    (2) The dispensers must be applied discretely, i.e., placed in the 
field in easily perceived distinct locations in a manner that does not 
prevent later retrieval. This exemption does not apply to codlure 
applied in a broadcast manner either to a crop field plot or to 
individual plants.
    (b) A codlure dispenser is a single enclosed or semi-enclosed unit 
that releases codlure into the surrounding atmosphere via 
volatilization and is applied in a manner to provide discrete 
application (i.e., in easily perceived distinct locations in a manner 
that does not prevent later retrieval) of the codlure into the 
environment.

[FR Doc. 94-4645 Filed 3-1-94; 8:45 am]
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