Unlud StatM Offioi of Pwldd* ind Toxic
Envtronnwnul Protection office of Partidd* Program (TS-766C)
Agmey Wohtngton. DC 20460
v>EPA Pesticide
Fact Sheet
Name of Chemical: Heiiothis NEV
Reason for Issuance:
Date Issued: June 30' 1984
Fact Sheet Number: 27
1. Description of Chemical
Generic Name: Beliothis tea (NPV)
Comfflon Name: He Hot his
Trade Names: Elcar, Biotrol VBZ and Viron/B
EPA Shaughnessy Code: 107301
Chemical Abstract Service (CAS) Number: 456H
Year of Initial Registration: 1975
Pesticide Type: Viral Insecticide
2. Use Patterns and Formations
Elcar* (Heliothis xea HPV) is registered for use on a
variety of crops. There is also an exemption from the
requirements of a tolerance established for the residues
of this nicrobial insecticide nuclear polyhedrosis virus
of Heliotbis tea, in or on all raw agricultural commodi-
t i es including :
Sites, aad Rates :
Terrestrial Pood Dse Rates (Ibs. active ingredient)
Application rates may vary from
0-.001 to 0.25 pound* .per acre
Lettuce
Peanuts
Sorghuf
Soybeans
Strawberry
Tomato
Cotton
Terrestrial Non Pood
Tobacco
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3. Science Findiri
Summary Science Statements:
Heliothis zea NPV does not appear to be toxic to man
or animal; i Tt does not appear to have any deleterious
effects on the environment. Beliothis zea NPV nas not
been shown to be neurotoxic, oncogenic, teratogenic or
mutagenic in the studies that have been reviewed to date.
Additional data are needed to determine the toxicity of
Beliothis zea NPV to wildlife. Prom the available data,
limited exposure to large animals, estuarine/marine
organisms and freshwater organisms is expected as a
result of the current label uses.
Chemical/Microbial Characteristics:
The nuclear polynedrosis virus (NPV) of cotton boliworm
Beliothis zea is a member of the occluded virus group of
baculovLruses which have unusually complex structure. It
contains double—stranded deoxyribonucleic acid genome
enclosed within a nucleocapeid in the polyhedral
inclusion body. The viral DNA is heterogenaps in size
with contour lengths ranging from 15 to 45 millimicrons,
and nas an estimated molecular weight of 30 x 106
daltons.
They are rods or cylinders and ellipsoids or oval
structures. The size of the enveloped virions
ranges from 60 to 70 millimicrons in vidtn b 260 to 300
millimicEône in length. The polyhedral inclusion bodies
..of Beliothis zea NPV which also vary in both snape and
size, rangibg om 0.65 to.l..93.microns in diameter.. qa.Q
be observed easily under tne light microscope.
The polyhedra which are made of large crystals of
protein, are insoluble in water, withstand treezinç and
a—wide range of environmental temperatures, and are
resistarft to baeterial putrefaction and to cnemica2 treat-
ments. However, the polyhedral inclusion bodies of
Beliotbis zea can be readily inactivated by short expos-
ure to natuial and artificial sunlight, and are suscepti-
ble to the treatment at nign pH witn solutions such as
0.1 M sodium carbonate. The treatment of polyhedra at
high pH can be used to tree the virions.
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Toxicology Cnaracteristics:
The means by wnicn the Heliotriis NPV infect t e insect
nests are not fully understood at present. Virus may be
squired eitner by moutn, transovarially, or as a result
of in ury, for example, through parasitism; oral infection
is tne most common by far of tnese three modes of acquisi-
tion. It is reasonable to believe tnat the high pn (pH
9.5 to 10) of the anterior midgut with some enzyaic
virus degradation activity is adequate to initiate poly—
nedral dissolution and virion release. Once released,
virions are directly exposed to the chemical conditions
within toe midgut lumen and enter into midgut cells.
Virion occlusion begins by the disposition of polynedral
material around single virion and later the polyhedron
enlarges to incorporate additional virions. It is uncer—
tair. flow toe polyhedral enlargement occurs. However,
when a large dose of Reliotnis NPV was fed to animals,
the infective He1iot is NPV was only detected in toe ali-
mentary tract, but greater tnan 99.9% of toe total virus
infectivity was either destroyed or excreted w tflin 48
hours. All animals remained nealtfly and nc adverse
effects of the treatment were reported. Similarly, in—
fective Heliotrais NPV was completedly oestroyec afte
two flours incubation in human gastric uice.’
Ecological Characteristics:
There are no data on the acute oral toxicity of Heliotnis
sea to birds. This data requirement remains unfulfilled.
No data were received relating to the acute pathogenicity
of Beliothis NPV to birds. This guideline requirement
remains unfilled. No data were received relating to
toxicity/patbogencity of Heliotnis to tresflwate.
invbrttord eb, thu thi i gui é1ine requirement ewains
unruif tiled.
Six studies on a formulated product of Hel otnis were
found to be acceptabl€ f or use in a hazard assessment.
They are: LC 50 values for rainbow trout-at 10% viru
were reported at approximately 96 hours. a being 2.06
ppm; white sucker at 1.0% test product, no effect at 100
ppm after 96 hours; black bullhead at 10% virus product
abowed no effect at 10 ppm; rainbow trout at l0 virus
product resulted In 100% mortality in test solutions
containing greater than 10 ppm concentrations after 96
hours; white sucker and black bullhead snowed no effect
at 70 ppm after 96 hours.
To address the ecological hazards, the Agency is requir-
ing tnat tne teet results from all of the Tier I n —
target organism tests, as noted in the current guidelines,
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be su m.tec in support o registration or reregistration
of all products containing the active ingredient Eeliotnis
zea.
Tolerance Exemption Assessments as per 40 CFR S180.1027:
Exemptions from the requirement of a tolerance are
establisned for the residues of the microbial insecticide
nuclear polynedrosis virus of Reliotnis zea , in or on
all raw agricultural commodities including: corn, cotton-
seed, beans, lettuce, okra, peppers, sorghum, soybeans,
tobacco, and tomatoes.
4. Summary of Regulatory Position and Rationale :
Because all fleliotnis zea products were registered under
the conventional pesticides data requirement guideline
before the promulgation of the current bioratiorial guide-
lines, tne Agency is requiring that all product analysis
data be submitted as in Tier I of the biorational data
guidelines, as well as most of Tier I data for Ecologi-
cal Effects.
5. Summary of Ma)or Data Gaps
The data requirements represent major data gaps for Helio—
this NPV. These data are required to be submitted to
the Agency within 2 years from the date of tne issuance
of the registration cocument.
Tier I S158.165 Nontarget Organisms
— Primary dermal study — Avian oral toxicity study
— Jlild mammal study
— Presrrwatet fidn study
— Freshwater aquatic invertebrate study
— Estuarine/marine animal testing study
— —Plant studies
— Non—target insect stuay
— -floneybee testing study
— Productanalysfs da:
6. Contact Person at EP .
Timothy A. Gardner
Product Manger (PM) 17,
Registration Division (TS—767C),
Office of Pesticide Programs,
Environmental Protection Agency,
401 M St., SW.,
lirthington, DC 20460
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Office location and telephone number:
Rsn. 202, CM $2,
1921 Jefferson Davis Highway,
Arlington, VA 22202,
(703)—557—2690.
DISCLAIMER: The information presented in this Cnemical
Information Fact Sheet is for informational purposes
only and may not be used to fulfill data requirements
for pesticide registration or reregistration.
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