[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