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pheromones Experimental Use Permits 6/94

[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]