[Federal Register Volume 60, Number 168 (Wednesday, August 30, 1995)]
[Notices]
[Pages 45156-45157]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-21038]



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ENVIRONMENTAL PROTECTION AGENCY
[OPP-50810; FRL-4972-2]


Lepidopteran Pheromones; Experimental Use Permits

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: EPA is expanding the minimum acreage from 10 acres to 250 
acres for when an experimental use permit (EUP) is required under the 
Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) for certain 
biological pesticides. This policy includes the majority of 
Lepidopteran pheromones, regardless of formulation or mode of 
application, when used at a maximum use rate of 150 grams active 
ingredient (ai)/acre/year. Tests conducted on these pheromones under 
the conditions specified in this notice would not require an EUP at 
acreages up to and including 250 acres. Tests conducted with other 
arthropod pheromone products on food crops entering commerce would 
still require an EUP and a temporary tolerance or exemption from the 
requirement of a temporary tolerance. Similarly, testing on acreages 
exceeding 250 acres for all pheromones (food and non-food uses) still 
requires an EUP.

EFFECTIVE DATE: This policy becomes effective August 30, 1995.

FOR FURTHER INFORMATION CONTACT By mail: Phil Hutton, Product Manager 
(PM-90), Biopesticides and Pollution Prevention Division (7501W), 
Office of Pesticide Programs, Environmental Protection Agency, 401 M 
St., SW., Washington, DC 20460. Office location, telephone number, and 
e-mail address: 5th Floor, Crystal Station 1, 2805 Crystal Drive, 
Arlington, VA, (703) 308-8260, e-mail: [email protected].

SUPPLEMENTARY INFORMATION: EPA, in this policy, is providing additional 
regulatory relief for manufacturers, researchers and developers of 
certain Lepidopteran pheromones regardless of formulation or mode of 
application when used at rates less than or equal to 150 grams ai/acre/
year. For the purposes of this policy, Lepidopteran pheromones are 
defined as naturally occurring compounds designated by the unbranched 
aliphatics (with a chain between 9 and 18 carbons) ending in an 
alcohol, aldehyde or acetate functional group and containing up to 3 
double bonds in the aliphatic backbone. This definition encompasses the 
majority of Lepidopteran pheromones. While other types of chemical 
compounds have been demonstrated to be Lepidopteran pheromones, the 
Agency believes the type described here represents not only the 
majority of Lepidopteran pheromones but also those with the most 
complete toxicological data base.
    Section 5 of FIFRA, 7 U.S.C. 136c, and 40 CFR part 172 provide for 
issuance by EPA of EUPs 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. Accompanying a food-
use EUP is the requirement that any treated crops be destroyed or a 
temporary tolerance or exemption from the requirement of a temporary 
tolerance for residues in or on the crop be in place.
    Due to the unique characteristics of pheromones, EPA believes that 
pheromone products used for food purposes need to be tested at acreages 
greater than 10 acres and as high 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 sufficiently evaluate 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. 
EPA believes that 250 acres should be sufficient to determine the value 
for pesticidal purposes of most pheromones.

I. Background

    Biochemical pesticides are naturally occurring substances that 
elicit pesticidal effects by a nontoxic mode of action to the target 
pest. A pheromone is defined by EPA as a compound produced by an 
arthropod (insect, arachnid, or crustacean) that modifies the behavior 
of other individuals of the same species (40 CFR 152.25(b)(1)). 
Lepidopteran pheromones (a subset of arthropod pheromones) are those 
produced by a member of the order Lepidoptera, which includes 
butterflies and moths. One physical-chemical feature common to all 
these compounds is their volatility which is the basis for the 
signalling and homing mechanism. The Agency has registered 17 arthropod 
pheromones active ingredients, 11 of which are Lepidopteran pheromones.
    The Agency recognizes that pheromones are inherently different from 
conventional synthetic pesticides in their nontoxic pesticidal mode of 
action, low use rate, and target species specificity, and is employing 
various measures to facilitate their development and ultimate 
registration. In January 1994, EPA expanded the minimum acreage 
required for an EUP to 250 acres for arthropod pheromones in polymeric 
matrix dispensers with an annual application rate limitation of 150 
grams/acre (59 FR 3681; January 26, 1994). The following July, EPA 
broadened the regulatory scope of the EUP minimum acreage limit to 
include broadcast applications and sprayable formulations of non-food 
uses of arthropod pheromones (59 FR 34182; July 7, 1994). EPA is now in 
the position to broaden 

[[Page 45157]]
the scope even further by including food uses of broadcast or sprayable 
applications of Lepidopteran pheromones under certain conditions 
outlined in this notice. It is important to note that this policy is 
only applicable to Lepidopteran pheromone products where the 
pheromone(s) is the sole active ingredient(s). Lepidopteran pheromone 
products formulated to include non-pheromone pesticide active 
ingredients, and non-lepidopteran pheromone products still require an 
EUP, when the treated area exceeds 10 acres and the formulation does 
not utilize a retrievable matrix.

II. Risk Considerations

A. Ecological Effects

    In regard to nontarget organism effects, the risks from broadcast 
applications to crop lands should not be greater than from forestry or 
other non-crop use if the same environmental hazard restrictions apply. 
Experimental use of broadcast applications are limited to 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. The Agency has previously 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 need for further regulatory relief above that provided for non-
food uses prompted the Agency to reconsider the human dietary exposure 
for broadcast applications. In its previous policy notice, EPA was not 
able to make a no unreasonable adverse effects finding for arthropod 
pheromone pesticides for use on food crops because of insufficient data 
on the levels of exposure from pheromones applied in a broadcast 
manner. For pheromone products, especially those directly applied to 
food, one problem has been a lack of subchronic toxicity studies and an 
estimate of the actual pheromone residues occurring with use. The 
Agency has contended that sprayable formulations or other modes of 
application of pheromones to raw agricultural commodities had the 
potential to increase the likelihood of human dietary exposure. The 
Agency, at this time, still does not have adequate data to support the 
inclusion of all uses of arthropod pheromones in its EUP policy. It 
does possess enough information, however, to include the straight-
chained Lepidopteran pheromones, a significant subset.
    Human health concerns arise for any experimentally treated crops 
that may enter the food supply. From the data submitted, the Agency was 
able to conclude that the potential for residues from Lepidopteran 
pheromones, as described in this notice, is not a dietary hazard. This 
conclusion is based on: (1) The low acute toxicity seen in the data 
review of the Lepidopteran pheromones registered to date; (2) the known 
metabolism of long-chain fatty acids that predicts these compounds 
would be metabolized either by beta-oxidation yielding a series of 
paired carbon losses or by complexing with glucuronide and excretion by 
the kidneys; and (3) low exposure subsequent to application from 
product aging, volatilization, and the results of the field residue 
studies. Elsewhere in this issue of the Federal Register, EPA is 
proposing an exemption from the requirement of a permanent tolerance 
for these straight-chained Lepidopteran pheromones under the Federal 
Food, Drug, and Cosmetic Act.
    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 Lepidopteran 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.

III. Conclusion

    Today's notice sets forth that for food uses of the majority of 
Lepidopteran pheromone pesticides, regardless of formulation or mode of 
application, 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. For 
the purposes of this policy, Lepidopteran pheromones are defined as 
naturally occurring compounds which are unbranched aliphatics (with a 
chain between 9 and 18 carbons) ending in an alcohol, aldehyde or 
acetate functional group and containing up to 3 double bonds in the 
carbon chain. Synthetically produced compounds that are identical to a 
known Lepidopteran pheromone as described above, and those that differ 
only in that their molecular structures are stereochemical isomers (or 
ratios of such isomers) also are included in this notice. The Agency 
contends, that for experimental uses involving food crops and all other 
non-aquatic 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. 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.
    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 synthetic 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.

List of Subjects

    Environmental protection, Experimental use permits.

    Dated: August 18, 1995.
Janet L. Andersen,
Acting Director, Biopesticide and Pollution Prevention Division, Office 
of Pesticide Programs.

[FR Doc. 95-21038 Filed 8-29-95; 8:45 am]
BILLING CODE 6560-50-F