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pheromones Experimental Use Permits 1/94

ENVIRONMENTAL PROTECTION AGENCY

[OPP-50573; FRL-4755-1] 

Arthropod Pheromones in Solid Matrix Dispensers; 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 a class of biological 
pesticides. This class of pesticides covers arthropod pheromone 
products in solid matrix dispensers used at rates at or below 
a total use rate of 150 grams active ingredient (AI)/acre/year. 
Tests conducted on these pheromone formulations under the conditions 
specified in this notice would not require an EUP at acreages 
up to and including 250 acres. Tests conducted on acreages exceeding 
250 acres would require an EUP. 

FOR FURTHER INFORMATION CONTACT: By mail: Phil Hutton, Registration 
Division, (7505C), Environmental Protection Agency, 401 M St., 
SW., Washington, DC 20460. Office location and telephone number: 
Rm. 213, Crystal Mall #2, 1921 Jefferson Davis Highway, Arlington, 
VA, 707-305-7690.

SUPPLEMENTARY INFORMATION: 

I. Introduction 

   In keeping with the Administrator's commitment to reduce 
the use of higher risk pesticides and provide incentives for 
the adoption of lower-risk pest management methods, EPA is announcing 
in this notice a new policy of allowing testing of pheromones 
in solid matrix dispensers (e.g., twist ties, plastic tapes, 
and ropes) on no more than 250 acres to proceed without an EUP. 
EPA recognizes that alternative pest control strategies, integrated 
pest management, and reduced risk pesticides, such as pheromones 
in solid matrix dispensers, are fundamental elements of an overall 
program to reduce risks to humans and the environment. 
   Insect species utilize certain volatile compounds, semiochemicals, 
and pheromones, to communicate with each other (e.g., to locate 
and attract mates or give alarm). For purposes of this notice, 
EPA defines a semiochemical as a chemical that transmits messages 
between living organisms. A pheromone, which is a type of semiochemical, 
is defined as a compound produced by an arthropod which, alone 
or in combination with other such compounds, modifies the behavior 
of other individuals of the same species (40 CFR 152.25(b)(1)). 
Even very low amounts of these naturally occurring volatile 
compounds can confuse normal insect behavior thus interrupting 
mating and preventing reproduction. 
   These chemicals may pose a relatively low risk alternative 
for managing insect pest populations. The use of semiochemicals, 
including pheromones, to attract and trap insects has been a 
viable pest management technology for a considerable period 
of time. In 1979, EPA first registered pheromones for use in 
traps for the purpose of mass trapping Japanese Beetles. Since 
then, the Agency has registered approximately 30 semiochemical 
pesticides with approximately 20 active ingredients being Lepidoptera 
pheromones. 
   It was in the late 1970s that EPA recognized that biochemical 
pesticides, including pheromones, were inherently different 
from most broad spectrum conventional pesticides and encouraged 
their development and registration, considering them to be potentially 
lower risk alternatives to conventional synthetic products on 
the market. The development of reduced safety data requirements 
currently in place for the registration of biochemical pesticides 
is based on the Agency's classification of a biochemical pesticide 
by two criteria: (1) The compound's non-toxic mode of action 
on the target pest, and (2) the natural occurrence of the compound. 
While not criteria for biochemical classification, arthropod 
pheromone products also have a low use rate, usually below 20 
grams per acre, and target species specificity, therefore less 
expected environmental impact than other pesticides. 
   The conditions under which an EUP, the first step in the 
regulation process, is required and the data which is required 
for an EUP application are major areas of concern by researchers 
and producers of pheromone pesticide products. A 1987 survey 
of companies actively involved in the registration of pheromones 
and companies that have considered and rejected pheromone development 
indicated that industry considered data requirements for pheromones 
to be excessive given the relatively safe nature of these substances, 
their extremely low rate of application, and their short persistence. 
Furthermore, it was noted that the applicant must incur the 
costs of developing most of the data to obtain an EUP, a stage 
in the product's development often too early to tell whether 
the pheromone is viable as a pesticide product. Given the limited 
earning potential of pheromone products, such testing costs 
tend to be prohibitively expensive; this is in addition to the 
high initial production costs of the pheromones themselves. 
   Over the years, industry has suggested several changes in 
EPA rules and procedures to aid the development and ease the 
regulatory standards for pheromones and similar semiochemicals. 
The Agency is now at a point where it believes there is a sufficient 
body of information in the public literature and has adequate 
data available on arthropod pheromones, and is now taking steps 
toward this end. 
   Today's notice announces a new agency policy of allowing 
pheromones in solid matrix dispensers to be tested on acreages 
not exceeding 250 acres of land under the conditions specified 
in this notice without an EUP. This policy only applies to arthropod 
pheromones in solid matrix dispensers, as defined in this notice, 
applied at rates not to exceed 150 grams AI/acre/year. 
   Conditional relief consisting of exemption from regulation 
under FIFRA has previously been granted by EPA for pheromone 
traps in which the pheromones are the sole active ingredient(s) 
(See 40 CFR 152.25(b)). In addition, EPA, on its own initiative, 
issued a proposed rule in the Federal Register of December 8, 
1993 (58 FR 64538), which proposes to exempt from the requirement 
of a tolerance under the Federal Food, Drug, and Cosmetic Act 
(FFDCA) the residues of arthropod pheromones resulting from 
the use of these substances in solid matrix dispensers with 
an annual application rate limitation of 150 grams AI/acre/year 
for pest control in or on all raw agricultural commodities. 
The scope of pheromone products exempted by this tolerance proposal 
would be the same as the scope of products subject to this notice. 
EPA currently is considering whether to take additional actions 
to grant further regulatory relief for other types of pheromone 
products. If EPA determines that any such regulatory relief 
is warranted, EPA would announce such a decision in a future 
Federal Register notice.

II. 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 EUP's for the testing of new, 
unregistered, pesticides or registered pesticides being tested 
for new uses, in which the purpose is only to determine its 
value for pesticide purposes or to determine its toxicity or 
other properties. 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 not more than 10 acres of 
land, does not require an EUP provided that the crops are destroyed 
or an appropriate tolerance 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 . 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. 
   EPA believes that pheromone products in solid matrix dispensers 
must be tested at acreages larger than 10 acres and as large 
as 250 acres to determine the products' value for pesticidal 
purposes. The 10 acre presumption in 40 CFR 172.3(a) is appropriate 
for most substances, which can be tested to determine their 
value for pesticidal purposes at small acreages below 10 acres. 
Due to the unique characteristics of pheromones in solid matrix 
dispensers, however, these products must be tested at much larger 
acreages. Most pheromone uses involve mating disruption. Unlike 
traditional toxicants which usually focus on killing the immature 
insect (which often does the most damage), pheromones act upon 
the adult. 
   Insects use pheromones to locate potential mates. When pheromones 
are introduced over an area by man as a pest control technique, 
the insects become confused by the seemingly ubiquitous presence 
of the guiding compound and therefore cannot find a suitable 
mate. When successful, pheromone applications result in reduced 
mating, lower insemination rates, and therefore lower population 
densities in the next generation. The evaluation of pheromones 
cannot be accomplished on small acreages because the treated 
area must be of sufficient size to account for the natural flight 
range of the target pests, such that already mated females flying 
into the test area do not skew the results of the study. This 
problem does not occur for most traditional toxicant pesticides 
which usually target the immature stage as these earlier life 
stages do not possess the capability of flight. 
   An additional factor necessitating larger acreages is the 
volatile nature of most pheromone compounds. It is unfeasible 
to adequately separate treatments with small plots. For these 
reasons pheromones are usually tested in plot sizes ranging 
from 20 to 60 acres, depending upon the nature of the treated 
site and the pest in question. To provide scientifically sound 
information, it is generally conceded that four to six replications 
are necessary to validate the findings. Thus, the position that 
250 acres should be sufficient to determine the value for pesticidal 
purposes of most pheromones. Moreover, as discussed in the section 
entitled ``Exposure and Effect,'' below, EPA believes that pheromones 
in solid matrix dispensers tested on no more than 250 acres 
and at maximum application rates of 150 grams AI/acre/year will 
not cause unreasonable adverse effects on the environment. 

III. Exposure and Effect 

   Since 1986, EPA has reviewed many arthropod-active pheromone 
products and has extensively reviewed pheromone toxicology data 
from the public literature. Based on this information, discussed 
more fully below, EPA believes that field tests conducted with 
pheromones in solid matrix dispensers and under the conditions 
outlined in this policy, will not cause unreasonable adverse 
effects on the environment. This conclusion is based on a number 
of factors, including the generally low toxicity and high volatility 
of pheromones, the low environmental and human exposure expected 
from pheromones used in solid matrix dispensers, and the low 
application rates and limited acreage required by this policy. 
Although the natural background level of pheromones in the atmosphere 
has never directly been determined, atmospheric levels for some 
pheromones have been estimated for peak population levels based 
on the pheromone emission rates for individual female arthropods. 
These estimated values range widely since they can be based 
on the amount of pheromone present in extracted glands or the 
measured emission rate and depend on what is considered the 
adult population during a peak pest infestation. To safeguard 
for the lack of data on natural background levels, EPA has determined 
to set an upper limit on the total amount of active ingredient 
released per acre per year from solid matrix dispensers at 150 
gm. The upper limit rate is necessary to ensure that pheromones 
used in solid matrix dispensers do not result in increased levels 
of pheromones beyond natural background levels. 
   The current upper limit for the application of a biochemical 
active ingredient lacking significant toxic effects that does 
not require the submission of residue data is 20 grams AI/acre 
(40 CFR 158.690(b)(2)(B)). To facilitate testing of pheromones 
for pesticidal purposes, the Agency is setting a more realistic 
upper limit for the amount of active ingredient released during 
a season before an EUP is required. The Agency has found that 
given the low expected toxicity and high volatility of arthropod 
pheromones, an upper limit of 150 grams AI/acre/year is adequate 
for testing a pheromone product's feasibility and efficacy while 
still protecting public health, nontarget organisms and the 
environment from unreasonable risks from compound levels which 
may be above ambient natural productions. These application 
rates encompass the majority of pheromone uses seen by the Agency 
to date. 

IV. Human Health 

   The study results and submitted data available to date have 
indicated the following: acute oral toxicity - (LD50 > 5,000 
mg/kg category IV (nontoxic)); acute dermal toxicity (LD50 > 
2,000 mg/kg category 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. 
   EPA has reviewed the results of submitted mammalian toxicology 
studies for the pheromone products registered to date and also 
pheromone toxicology data from the public literature. The majority 
of the compounds registered to date (26 of 31) have been Lepidopteran 
(e.g. butterfly and moth) pheromones. These registered pheromones 
fall within a well defined class of chemical structures: aliphatic 
compounds with straight chains from 9 to 18 carbons in length 
and up to 3 double bonds, and ending in an acetate, alcohol, 
aldehyde functional group. Pheromones have been discovered with 
other chemical structures including compounds with ketone, epoxide, 
lactone, terpenoid, pyrazine, pyran, and aromatic structures. 
In 1983, when EPA promulgated the exemption for pheromones used 
in traps, the Agency did not distinguish between the rather 
restricted class of chemicals produced by Lepidopteran species 
and pheromones with different chemical structures produced by 
other arthropod species (e.g. beetles, flies, and mites) for 
use in traps. Because the proposed interpretation that the use 
of pheromones in solid matrix dispensers at an annual rate of 
up to 150 gm AI/acre represents the same human risk as the use 
of pheromones in traps, EPA does not believe there is a reason 
to distinguish between chemical classes of pheromones for pheromones 
in solid matrix dispensers. 
   While the toxicology data base for pheromones with structures 
outside the well defined aliphatic Lepidopteran pheromones, 
such as aromatic compounds, is not as extensive, there is no 
indication of significant toxic effects to mammalian species 
from those compounds registered to date. The literature indicates 
that some aromatic pheromone compounds could be potentially 
toxic due to structural similarities to other aromatic compounds. 
The data available to date on both Lepidopteran and other arthropod 
pheromones, including several aromatic pheromones, however, 
have indicated no mammalian toxicity at the limit dose levels. 
   The volatility of these compounds also predicts that little, 
if any, of the released compound will actually be associated 
with the crop. Studies to measure the natural background levels 
of insect pheromones in the environment or in or on fruit indicate 
little or no detectable residues. When pheromone residue analyses 
were done on fruit treated with from 129 to 141 gm AI/acre, 
no residues could be found with a detection limit of 2 to 5 
ppb (Refs. 1 and 2). The current regulations provide that, in 
the absence of any significant toxic effects, residue analysis 
can be required when biochemical pesticides are applied above 
20 gm AI/acre (40 CFR 158.690(b)). The Agency recognizes that 
the 150 gm AI/acre/yr rate is well above the 20 gm/acre limit 
triggering a food residue analysis. However, the negligible 
exposure for pheromones in dispensers, the natural occurrence 
of these compounds, their rapid biodegradation, high volatility 
and low worker exposure associated with solid matrix dispensers 
justify raising the limit for when an EUP is required for testing 
these volatile biochemical pesticides. 
   Moreover, the Agency believes that an upper limit of 150 
gm AI/acre/year for pheromones labeled for use in dispensers 
as described below does not present a significant risk of dietary 
exposure due to the unlikelihood of direct contact with food 
and the low probability of deposition on food or feed following 
atmospheric dilution. EPA, on its own initiative, issued a proposed 
rule in the Federal Register of December 8, 1993 (58 FR 64538), 
which proposes to exempt from the requirement of a tolerance 
under the Federal Food, Drug, and Cosmetic Act (FFDCA) the residues 
of arthropod pheromones resulting from the use of these substances 
in solid matrix dispensers with an annual application rate limitation 
of 150 grams AI/acre/year for pest control in or on all raw 
agricultural commodities. However, until this exemption from 
the requirements of a tolerance becomes a final rule (anticipated 
in February 1994), a temporary tolerance and EUP application 
will be required if the treated crop enters channels of trade. 
A final rule establishing an exemption from the requirements 
of a tolerance for inert ingredients of retrievably sized semiochemical 
dispensers composed of polymeric matrix materials was published 
in the Federal Register of December 8, 1993 (58 FR 64493). 

V. Ecological Effects 

   Wildlife toxicity data indicate: high toxicity to aquatic 
invertebrates and moderate toxicity to fish, but practically 
no toxicity to birds tested. Data for one Lepidopteran pheromone 
indicate low toxicity to avian bobwhite quail (acute oral LD50 
of >2,000 mg/kg of body weight and dietary LC50 of >5,000 mg/kg). 
However, this pheromone had a freshwater aquatic invertebrate 
(Daphnia magna) LC50 of between the solubility limit of 0.2 
mg/l and a calculated LC50 of 0.58 mg/l. Observations of oily 
surface films at higher test concentrations confirmed the low 
solubility of the test material. The conclusion was that this 
pheromone was highly toxic to Daphnia and that the calculated 
LC50 supported this conclusion. Whether the mortality was due 
to the pheromone in solution or a film on the water was not 
determined. Another Lepidopteran pheromone was found to be moderately 
toxic to both Daphnia magna (LC50 8.6 mg/l) and the freshwater 
rainbow trout (LC50 5.9 mg/l). These results are sufficient 
to demonstrate the potential toxicity of Lepidopteran pheromones 
to nontarget aquatic organisms. 
   Although pheromones may be in matrix dispensers, rates of 
dissociation from matrices into water are not known. Refined 
petroleum oils which form films at the water surface are registered 
by the Agency as pesticides for control of mosquito larvae and 
pupae. Pesticidal oils, which may comprise some of these products, 
kill by arresting invertebrate respiration and affect interfacial 
tension at the water surface upon which various arthropods depend 
for functions including feeding, movement, and reproduction. 
To minimize the potential toxic effects on aquatic organisms, 
the pheromone formulations in solid polymeric matrix retrievably 
sized dispensers should be for terrestrial use only and the 
experimental use should not include use in or around marshes, 
swamps, rivers, streams, ponds, lakes, estuaries, flood plains, 
or drainage ditches. They should not be allowed to wash or drain 
into water. 
   Despite the toxicity to aquatic organisms from pheromones, 
EPA believes that risks to aquatic organisms for tests conducted 
under the conditions outlined in this notice are low. Pheromones 
in solid matrix dispensers would not be expected to be used 
in water. In addition, many of the solid matrix dispensers of 
the type covered by this policy are typically affixed to trees 
or plants or other fixed objects, and thus, are not likely to 
end up in bodies of water. 
   Broadcast application is not included in this notice because 
the Agency does not have sufficient information on the levels 
of exposure from pheromones which are broadcast. 

VI. Solid Matrix Dispensers 

   Solid matrix dispensers, as defined in this notice, include, 
but are not limited to: Rubber septa dispensers, trilaminate 
sheets, tapes, tags, wafers, macrocapillary devices, such as 
long tubes or fibers, twist ties, or ropes which are placed 
by hand in the field and are of such and construction that they 
are readily seen. This policy does not apply to the following 
formulations: Liquid flowables, microcapsules, microcapillary 
straws, granular powder, flakes, or confetti formulations which 
are sprayed or broadcast over an area; and cigarette filters 
or unprotected ropes which generally contain the active ingredient 
on the outer surface of the unit. The dispensers must not be 
of a size, odor, taste or have other characteristics making 
them attractive to wildlife that potentially could collect or 
eat them. Devices like netting, webbing, loose filaments, and 
adhesives capable of trapping or ensnaring nontarget organisms 
such as birds also would not be covered by this policy. If inadvertently 
eaten, these dispensers should be nontoxic and readily pass 
through an animal digestive system without causing blockage 
or puncture. 

VII. Agency Determinations

   EPA has determined, pursuant to 40 CFR 172.3, to expand the 
land use limitation for testing for pesticidal value without 
the need for an EUP from 10 acres to 250 acres for arthropod 
pheromones in solid matrix dispensers using no more than 150 
grams AI/acre/year. This determination is based both on a finding 
that tests conducted under the conditions outlined will not 
cause unreasonable adverse effects on the environment and on 
EPA's belief that it is necessary to test pheromones in solid 
matrix dispensers on large acreages (i.e., larger than 10 acres) 
to determine their value for pesticidal purposes. EPA retains 
the authority under 40 CFR 172.3 to require EUP's, on a case-
by-case basis, for tests conducted on acreages smaller than 
250 acres if EPA determines that the test is not being conducted 
only for the purpose of determining the pheromone's value for 
pesticidal purposes or if EPA determines that the test may cause 
unreasonable adverse effects on the environment in the absence 
of agency oversight in the form of an EUP. 
   Today's notice only addresses EPA's policy with regard to 
EUP's for pheromones in solid matrix dispensers. This notice 
does not in any way obviate the need to obtain a tolerance under 
the FFDCA before using a pheromone product for food or feed 
use. EPA intends to address use of pheromones in solid matrix 
dispensers on food or feed crops with an exemption from the 
requirement for a tolerance under FFDCA. Such a proposed exemption 
was published in the Federal Register of December 8, 1993 (58 
FR 64538). Moreover, EPA has published a final rule exempting 
certain inert ingredients used in solid matrix dispensers from 
the requirement of tolerance (December 8, 1993, 58 FR 64493). 
   Today's notice in no way affects the need to obtain an EUP 
for tests conducted on more than 10 acres with formulations 
of pheromones products other than those described in the notice 
(i.e., pheromone formulations which are physically smaller than 
solid matrix dispensers, such as sprayables). EUP's will continue 
to be required for tests conducted on more than 10 acres using 
non-solid matrix dispenser formulations. 
   EPA currently is considering whether to take additional actions 
to grant further regulatory relief for other types of pheromone 
products. If EPA determines that any such regulatory relief 
is warranted, EPA would announce such a decision in a future 
Federal Register notice. 

VIII. References

   (1) Spittler, T. D.; Leichtweis, H. C.; Dennehy, T. J. (1988). 
Biorational Control of Crop Pest by Mating Disruption; Residue 
Analyses of Z-9-Dodecen-1-yl Acetate and Z-11-Tetradecenyl-1-
yl Acetate in Grapes. In: Biotechnology for Crop Protection, 
P. Hedin, J. J. Menn and R. Hollingworth (eds.) ACS Symposium 
Series, 379:430-436.
   (2) Spittler, T. D., Leichtweis, H. C., Kirsch, P. (1992). 
Exposure, Fate and Potential Residues in Food of Applied Lepidopteran 
Pheromones. In: Insect Pheromones and Other Behaviour-Modifying 
Chemicals: Application and Regulation, R. L. Ridgeway, M. Inscoe 
and H. Arn (eds.), BCPC Monograph No. 51, pp. 93-108. 

   Dated: January 19, 1994. 

Stephanie R. Irene,
Acting Director, Registration Division, Office of Pesticide 
Programs. 

[FR Doc. 94-1615 Filed 1-25-94; 8:45 am]