[Federal Register Volume 59, Number 129 (Thursday, July 7, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-16461]
[[Page Unknown]]
[Federal Register: July 7, 1994]
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ENVIRONMENTAL PROTECTION AGENCY
[OPP-50791; FRL-4869-8]
Arthropod Pheromones; Experimental Use Permits
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice.
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SUMMARY: EPA is announcing in this notice that it is expanding the
acreage cut-off for when an experimental use permit (EUP) is required
under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA)
from 10 acres to 250 acres for certain uses of biological pesticides.
These uses include arthropod pheromones, irrespective of formulation,
when used in non-food areas at a maximum use rate of 150 grams active
ingredient (ai)/acre/year. Tests conducted on these pheromone uses
under the conditions specified in this notice would not require an EUP
at acreages up to and including 250 acres. Tests conducted with
pheromone products on food crops entering commerce would still require
an EUP and a temporary tolerance or an exemption from the requirement
of a temporary tolerance. Similarly, testing on acreages exceeding 250
acres for all pheromones (food and nonfood uses) still requires an EUP.
EFFECTIVE DATE: This policy becomes effective July 7, 1994.
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) 305-7690.
SUPPLEMENTARY INFORMATION:
I. Introduction
Biological pesticides, which include biochemical and microbial
pesticides, comprise the single fastest growing segment of registration
activity within EPA's Office of Pesticide Programs. Biochemical
pesticides encompass both semiochemicals and pheromones plus other
naturally occurring substances that elicit pesticidal effects by a
nontoxic mode of action to the target pest [40 CFR 158.65(a)]. A
semiochemical is a biochemical that transmits messages between living
organisms. A pheromone is a subclass of semiochemicals and is defined
as a chemical produced by an arthropod that modifies the behavior of
other individuals of the same species [40 CFR 152.25(b)(1)]. Currently
only pheromones labeled for use in pheromone traps and in which the
pheromone are the sole active ingredient(s) are exempt from regulation
under FIFRA [40 CFR 152.25(b)].
The Agency recognizes that pheromones are inherently different in
their nontoxic pesticidal mode of action, low use rate, and target
species specificity, and is employing various measures to facilitate
their registration. Most recently the Agency has provided some
regulatory relief for pheromones in retrievably sized polymeric matrix
dispensers. EPA exempted the inert ingredients in the polymeric matrix
dispenser from the requirement of a tolerance under the Federal Food,
Drug, and Cosmetic Act (FFDCA) on December 8, 1993 (58 FR 64493). EPA
issued in the Federal Register of January 26, 1994 (59 FR 3681), a
notice expanding the minimum acreage required for an experimental use
permit from 10 to 250 acres for arthropod pheromones in polymeric
matrix dispensers with an annual application rate limitation of 150
grams/acre for pest control in or on all raw agricultural commodities.
And most recently, on March 30, 1994 (59 FR 14757), EPA exempted from
the requirement of a tolerance under FFDCA the residues of arthropod
pheromones resulting from the use of these compounds in polymeric
matrix dispensers at the above use rates.
EPA has determined that additional regulatory relief for pheromones
is warranted. The Agency now wishes to further broaden the scope of
regulatory relief for arthropod pheromone researchers and producers to
formulations beyond traps and polymeric matrix dispensers by including
broadcast applications under certain non-food use conditions outlined
in this notice. With the implementation of this policy, EPA hopes to
encourage the development and use of environmentally acceptable
biological pesticides as alternatives to more toxic conventional
chemical pesticides. The aim is to ease the testing requirements of
these products, to speed their market entry, and promote their
integration into pest management strategies. It is important to note
that this policy is only applicable to arthropod pheromone products
where the pheromone is the sole active ingredient(s). For pheromone
products formulated to include other pesticide active ingredients, the
data requirements for biological/chemical pesticides is appropriate [40
CFR part 158].
The need for further regulatory relief above that provided for
retrievable polymeric matrix dispensers prompted the Agency to
reconsider broadcast application. Of consideration were human dietary
exposure, promotion of reduced risk alternative pesticides,
persistence, and environmental risk. In regard to nontarget organism
effects, the risks from broadcast application should not be appreciably
greater than from a polymeric dispenser application if the broadcast
formulations are also for terrestrial use only and experimental
application does not include use in or around marshes, swamps, rivers,
streams, ponds, lakes, estuaries, flood plains, or drainage ditches,
nor should the product be allowed to wash or drain into water. Low
rates of experimental application, high volatility, limited acreage,
and the current extent of knowledge indicating generally low orders of
toxicity are all justifications to overcome potential increased risks
to nontarget organisms due to exposure to foliar residues.
Today's notice sets forth that for non-food uses of arthropod
pheromone pesticides only, EPA is permitting the acreage expansion from
10 to 250 acres for experimental testing at a maximum use rate of 150
grams ai/acre/year before triggering the requirement of an EUP under
FIFRA. The Agency contends, that for experimental uses involving non-
food crops and other nondietary uses, this change in policy provides
significant flexibility to determine product efficacy without resulting
in significant risk to human health or the environment due to the
active ingredient's low use rate, high volatility, and lack of dietary
exposure.
II. Toxicology
A. Ecological Effects
Wildlife toxicity data indicate high toxicity to aquatic
invertebrates and moderate toxicity to fish, but practically no
toxicity to birds tested. Therefore, these products should not be
applied directly to water nor be allowed to runoff into water. To
minimize the potential toxic effects on aquatic organisms, this policy
is limited to pheromone products tested for terrestrial use only and
would not apply to pheromones for use in or around marshes, swamps,
rivers, streams, ponds, lakes, estuaries, flood plains, or drainage
ditches. The Agency believes that aquatic exposure will be minimal if
experimental use is limited to the terrestrial use only pattern of the
pheromone. Similarly, the Agency has determined that exposure to
wildlife will be minimal when release of the pheromone is confined to
experimental purposes only and applications are limited to a maximum of
150 grams ai/acre/year on a maximum of 250 acres.
B. Human Health
The data available to date on arthropod pheromones, including
several pheromones with aromatic structures, have indicated no
mammalian toxicity at the limit dose levels recommended for the
following studies: acute oral toxicity (LD50 >5,000 mg/kg -
category IV, nontoxic), acute dermal toxicity (LD50 >2,000 mg/kg
category III-IV, nontoxic), acute inhalation toxicity (LD50
generally >5 mg/L - category III-IV, practically nontoxic), no evidence
of mutagenicity (Ames Salmonella assay), and minimal eye and skin
irritation. In general, the Agency recommends, however, that whenever
using pesticides, adequate precautions to minimize applicator exposure
should be taken.
Human health concerns arise for any experimentally treated crops
that may enter the food supply. Experimentally treated food crops are
normally destroyed as a routine provision to prevent the food from
entering commerce. Crop destruction, however, may not be economically
feasible for crop acreages of up to 250 treated acres. Under FFDCA, a
food tolerance or an exemption from the requirement of a tolerance must
be established prior to any treated crop entering commerce or the
seller of the food crop will be in violation of FFDCA provisions for
pesticide residues in food. Temporary tolerances may be established for
food crops that have been treated with experimental pesticides under an
EUP.
EPA is not able at this time to make a no unreasonable adverse
effects finding for arthropod pheromone pesticides for use on food
crops. Subsequent testing on food or feed crops of other formulations
involving, for example, broadcast sprays or dispensers that are not
retrievable, will require an EUP to generate adequate data for
determining a food tolerance, or exemption from tolerance, and the
greater exposure potential of the pesticide to the resulting food. For
these uses, an EUP is needed to accompany a temporary tolerance and to
generate adequate data to allow for a food tolerance determination.
Requests for exemption from the requirement of a temporary tolerance
will also be considered in conjunction with an EUP. EPA would consider
waivers for many requirements for an experimental use permit on
acreages from 10 to 250 acres and use rates up to a maximum of 150
grams ai/acre/year.
In the past, EPA has waived some or all of the required toxicology
studies for volatile biochemical pesticide active ingredients in
dispensers when the registrant has demonstrated an extremely low
exposure scenario, lack of food residues, and inert materials of the
dispenser were cleared by the Agency. The Agency will consider waivers
for studies of other pheromone formulations when the registrant can
adequately demonstrate that either a low application rate, rapid
degradation of the active ingredient, high volatilization, and/or
timing of the last application prior to harvest will result in no
detectable pesticide residues in or on the food crop.
III. Statutory and Regulatory Authority
Section 5 of FIFRA, 7 U.S.C. 136c, and 40 CFR part 172 provide for
issuance by the Agency of experimental use permits for the testing of
new, unregistered pesticides or new uses of existing pesticides for
product performance and registration purposes. Such permits are
generally issued for large-scale testing of pesticides on more than 10
acres. Contained within the scope of the regulation, however, is the
presumption that small-scale testing, i.e., on less than 10 acres of
land, does not require an EUP providing that any treated crops are
destroyed or a temporary tolerance for residues in or on the crop is in
place (40 CFR 172.3(a)). This presumption, however, is caveated not to
preclude experimental testing on larger areas in certain circumstances
where the purpose of the large acreage test is only to determine the
substance's value for pesticidal purposes or to determine its toxicity
or other properties, and no benefit from pest control is expected (40
CFR 172.3(b)). EPA issued in the Federal Register of January 22, 1993
(58 FR 5878), a proposed amendment to 40 CFR part 172. The proposed
amendment would, among other things, modify Sec. 172.3 to clarify that
the determination of whether an EUP is required is based on risk
considerations. The amendment would provide that tests conducted on not
more than 10 acres of land are presumed not to involve unreasonable
risks, and therefore, do not require an EUP.
Due to the unique characteristics of pheromones, EPA believes that
pheromone products used for non-food purposes must be tested at
acreages larger than 10 acres and as large as 250 acres to determine
the products' value for pesticidal purposes. Many pheromone uses are
effective as mating disruptants to the adult insects. Larger test
acreages are needed to evaluate sufficiently the disruption of the
natural flight range of the adult target insect. An additional factor
necessitating larger acreages is the volatile nature of most pheromone
compounds. Separate treatments in adjoining small plots is unfeasible,
and test plot sizes ranging from 20 to 60 acres are usually required
depending upon the nature of the treated site and the pest in question.
Thus, EPA believes that 250 acres should be sufficient to determine the
value for pesticidal purposes of most pheromones.
The Agency has found that given the generally low expected toxicity
and high volatility of arthropod pheromones, an upper limit of 150
grams ai/acre/year is adequate for testing the pheromone product
performance while still protecting the public health, nontarget
organisms and the environment from unreasonable risks. These
application rates encompass the majority of pheromone uses seen by the
Agency to date.
IV. Agency Determination
EPA is now expanding the terrestrial use limitation for testing
arthropod pheromone pesticides without the need for an experimental use
permit from 10 acres to 250 acres for non-food use patterns at
treatment rates not exceeding 150 grams ai/acre/year. Upon meeting the
above conditions, the Agency has determined that pheromones of the type
described do not present an unreasonable adverse effect to human health
or the environment due to unlikely exposure.
The above policy applies to only the experimental phase of
pheromone product development and not to registration of the product.
The intent of this regulatory relief policy is to permit adequate
conditions for practical research and development, while protecting the
food supply and nontarget species from higher pheromone levels than
occur naturally. The current set of studies listed in 40 CFR 158.690
are still required for the registration and sale of the final product.
Dated: June 28, 1994.
Stephen L. Johnson,
Director, Registration Division, Office of Pesticide Programs
[FR Doc. 94-16461 Filed 7-6-94; 8:45 am]
BILLING CODE 6560-50-F