[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: hutton.phil@epamail.epa.gov.
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
