[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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