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Arthropod Pheromones; Experimental Use Permits 6/94

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]