pheromones Proposed Tolerance Exemption 11/93
Arthropod Pheromones; Tolerance Exemption
AGENCY: Environmental Protection Agency (EPA).
ACTION: Proposed rule.
SUMMARY: This document proposes that an exemption from the requirement
of a tolerance be established for residues of arthropod pheromones
resulting from the use of these substances in solid matrix dispensers
with an annual application limitation of 150 grams active ingredient
per acre (gm ai/acre) for pest control in or on all raw agricultural
commodities (RAC). This regulation is proposed by EPA at its
DATES: Comments identified by the docket number [OPP-300314]
must be received on or before January 7, 1994.
ADDRESSES: Submit written comments by mail to: Public Response
and Program Resources Branch, Field Operations Division (7506C),
Office of Pesticide Programs, U.S. Environmental Protection
Agency, 401 M St., SW., Washington, DC 20460. In person, bring
comments to: Public Docket, Rm. 1132, Crystal Mall #2, 1921
Jefferson Davis Highway, Arlington, VA 22202. Information submitted
as a comment concerning this document may be claimed confidential
by marking any part or all of that information as ``Confidential
Business Information'' (CBI). Information so marked will not
be disclosed except in accordance with procedures set forth
in 40 CFR part 2. A copy of the comment that does not contain
CBI must be submitted for inclusion in the public record. Information
not marked confidential will be included in the public docket
by EPA without prior notice. The public docket is available
for public inspection in Rm. 1128 at the above address, from
8 a.m. to 4 p.m., Monday through Friday, excluding legal holidays.
FOR FURTHER INFORMATION CONTACT: By mail: Phil Hutton, Product
Manager (PM-18), Registration Division (7505C) Office of Pesticide
Programs, Environmental Protection Agency, 401 M St., SW., Washington,
DC 20460. Office location and telephone number: Rm. 213, CM
#2, 1921 Jefferson Davis Highway, Arlington, VA 22202, (703)
SUPPLEMENTARY INFORMATION: EPA proposes to amend 40 CFR part
180 by establishing an exemption from the requirement of a tolerance
for all arthropod pheromones used in solid matrix dispensers
at rates less than or equal to 150 grams active ingredient (ai)/acre/year.
A pheromone is defined by EPA as a compound produced by an
arthropod that modifies the behavior of other individuals of
the same species (40 CFR 152.25(b)(1)). EPA has examined the
data related to human health submitted for the approximately
30 arthropod pheromones registered to date as biochemical pesticides
as well as available published toxicology studies on this class
of compounds. The mammalian toxicology for these registered
arthropod pheromones indicates no acute toxicity for the oral
route of exposure (toxicity category IV = nontoxic). The compounds
tested were shown not to be mutagens via the Ames Salmonella
Since registration of approximately 30 arthropod pheromones
as active ingredients, the Agency has received no additional
factual information regarding unreasonable adverse effects on
human health or the environment relating to use of these pesticides.
In addition the Agency is unaware of any adverse health or environmental
effects resulting from pheromones when used in traps.
To date the Agency has not requested residue analyses for
these compounds due to their low mammalian toxicity and use
rates, which are generally below the 20 gm ai/acre limit triggering
food residue analysis (40 CFR 158.690(b)). In addition, the
low probability of redeposition of the pesticide onto the plant
after volatilization would predict that food or feed residues
are not detectable at these use rates. There is published information
for residue analysis of pheromones applied at 129 to 141 gm
ai/acre which reported that residues were not detectable in
harvested fruit using techniques with a detection limit of 2
to 5 parts per billion (Refs. 1 and 2). The Agency therefore
believes that an upper limit of 150 grams ai/acre/year for pheromones
in dispensers should result in no detectable residues in or
on foods or feed. Broadcast methods of application are not included
in this exemption because the Agency does not have sufficient
information on the levels of exposure from pheromones which
EPA has determined that, when used in accordance with good
agricultural practices, a tolerance is not necessary to protect
the public health due to low toxicity and negligible to non-
existent food residues expected from the use of these volatile
pheromones in solid matrices. Solid matrix dispensers, as defined
in this notice, include, but are not limited to: Rubber septa
dispensers, trilaminate sheets, tapes, tags, wafers, macrocapillary
devices, such as long tubes or fibers, twist ties, or protected
ropes which are placed by hand in the field and are of such
size and construction that they are readily recognized. Formulations
not included in this exemption are: Liquid flowables, microcapsules,
microcapillary straws; granular powder, flakes, or confetti
formulations which are sprayed or broadcast over the crop area;
and cigarette filters or unprotected ropes which generally contain
the active ingredient on the outer surface of the unit. These
smaller sized formulations are not exempt because they may be
of a size and shape readily consumed by birds and other wildlife.
A generic exemption for this low-risk, low-exposure group of
substances will facilitate the use of semiochemicals as alternatives
to conventional synthetic pesticides. Therefore, EPA proposes
that an exemption from the requirement of a tolerance be established
as set forth below.
Any person who has registered or submitted an application
for registration of a pesticide under the Federal Insecticide,
Fungicide, and Rodenticide Act (FIFRA) as amended, which contains
any of the ingredients listed herein, may request within 30
days after the publication of this document in the Federal Register
that this rulemaking proposal be referred to an Advisory Committee
in accordance with section 408(e) of the Federal Food, Drug,
and Cosmetic Act (FFDCA).
Interested persons are invited to submit written comments
on the proposed regulation. Comments must bear a notation indicating
the document control number, [OPP-300314]. All written comments
filed in response to this petition will be available in the
Public Response and Program Resources Branch at the above address
from 8 a.m. to 4 p.m., Monday through Friday, except legal holidays.
The Office of Management and Budget has exempted this notice
from the requirement of review pursuant to Executive Order 12866.
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).
(1) Spittler, T. D.; Leichtweis, H. C.; Dennehy, T. J. (1988)
Biorational Control of Crop Pests by Mating Disruption: Residue
Analyses of Z-9-Dodecen-1-yl Acetate and Z-11-Tetradecen-1-yl
Acetate in Grapes. In: Biotechnology for Crop Protection, P.
Hedin, J. J. Menn and R. Hollingworth (eds), ACS Symposium Series,
(2) Spittler, T. D.; Leichtweis, H. C.; Kirsch, P. (1992)
Exposure, Fate and Potential Residues in Food of Applied Lepidopteran
Pheromones. In: Insect Pheromones and Other Behaviour-Modifying
Chemicals: Application and Regulation, R. L. Ridgway, M. Inscoe
and H. Arn (eds), BCPC Monograph No. 51, pp. 93-108.
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
Dated: November 17, 1993.
Stephen L. Johnson,
Acting Director, Registration Division, Office of Pesticide
Therefore, it is proposed that 40 CFR part 180 be amended
1. The authority citation for part 180 continues to read
Authority: 21 U.S.C. 346a and 371.
2. By adding new . 180.1124 to subpart D to read as follows:
180.1124 Arthropod pheromones; exemption from the requirement
of a tolerance.
Arthropod pheromones, as described in 152.25(b) of this chapter,
when used in solid matrix dispensers are exempt from the requirement
of a tolerance in or on all raw agricultural commodities when
applied to growing crops only at a rate not to exceed 150 grams
active ingredient/acre/year in accordance with good agricultural
[FR Doc. 93-29829 Filed 12-7-93; 8:45 am]