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heliothis zea NPV (Heliothis) Chemical Fact Sheet 6/84

CHEMICAL FACT SHEET FOR:
HELIOTHIS ZEA NUCLEAR POLYHEROSIS VIRUS (NPV)


FACT SHEET NUMBER: 27

DATE ISSUED: JUNE 30, 1984


                    1.  DESCRIPTION OF CHEMICAL

- Generic Name:  Heliothis zea (NPV)
- Common Name:  Heliothis
- Trade Names:  Elcar, Biotrol VHZ, and Viron/H
- EPA Shaughnessy Code:  107301
- Chemical Abstracts Service (CAS) Number:  456H
- Year of Initial Registration:  1975
- Pesticide Type:  Viral insecticide
- Chemical Family:  Microbial control agent
- U.S. and Foreign Producers:


                   2.  USE PATTERNS AND FORMULATIONS

- Elcar (Heliothis zea NPV) 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 microbial insecticide nuclear
  polyhedrosis virus of Heliothis zea, in or on all raw agricultural
  commodities including:
- Application sites and rates:

  Terrestrial Food Use                   Rates (lbs. active ingredient)

      Beans                              Application rates may vary from
      Corn                               0.001 to 0.25 pounds per acre
      Lettuce
      Peanuts
      Sorghum
      Soybeans
      Strawberry
      Tomato
      Cotton


      Terrestrial Non-Food

      Tobacco

                       3.  SCIENCE FINDINGS

- Chemical Characteristics

  - The nuclear polyhedrosis virus (NPV) of cotton bollworm Heliothis
    zea is a member of the occluded virus group of baculoviruses which
    have unusually complex structure.  It contains double-stranded
    deoxyribonucleic acid genome oenclosed within a nucleocapsid in the
    polyhedral inclusion body.  The viral DNA is heterogenous in size,
    with contour lengths ranging from 15 to 45 millimicrons, and has an
    estimated molecular weight of 30 x 10-6 daltons.
  - They are rods or cylinders and ellipsoids or oval structures.  The
    size of the enveloped virions ranges from 60 to 70 millimicrons in
    width by 260 to 300 millimicrons in length.  The polyhedral
    inclusion bodies of Heliothis zea NPV, which also vary in both shape
    and size, ranging from 0.65 to 1.93 microns in diameter, can be
    observed easily under the light microscope.
  - The polyhedra, which are made of large crystals of protein, are
    insoluble in water, withstand freezing and a wide range of
    environmental temperatures, and are resistant to bacterial


Toxicological Characteristics

The means by which the Heliothis NPV infect the insect hosts are not
fully understood at present.  Virus may be acquired either by mouth,
transovarially, or as a result of injury, for example, through
parasitism; oral infection is the most common by far of these three
modes of acquisition.  It is reasonable to believe that the high pH
(pH 9.5 to 10) of the anterior midgut with some enzymic virus
degradation activity is adequate to initiate polyhedral dissolution
and virion release.  Once released, virions are directly exposed to
the chemical conditions within the midgut lumen and enter into midgut
cells.  Virion occlusion begins by the disposition of polyhedral
material around single virions, and later the polyhedron enlarges to
incorporate additional virions.  It is uncertain how the polyhedral
enlargement occurs.  However. when a large dose of Heliothis NPV was
fed to animals, the infective Heliothis NPV was only detected in the
alimentary tract, but greater than 99.9% of the total virus
infectivity was either destroyed or excreted within 48 hours.  All
animals remained healthy, and no adverse effects of the treatment were
reported.  Similarly, infective Heliothis NPV was completely destroyed
after two hours of incubation in human gastric juice.


- Ecological Characteristics

  - There are no data on the acute oral toxicity of Heliothis zea to
    birds.  This data requirement remains unfulfilled.  No data were
    received relating to the acute pathogenicity of Heliothis NPV to
    birds.  This guideline requirement remains unfilled.  No data were
    received relating to toxicity/pathogenicity of Heliothis to
    freshwater invertebrates, thus this guideline requirement remains
    unfulfilled.
  - Six studies on a formulated product of Heliothis were found to be
    acceptable for use in a hazard assessment.  They are:  LC50 values
    for rainbow trout at 10% virus were reported at approximately 96
    hours as being 2.06 ppm; white sucker at 10% test product, no
    effect at 100 ppm after 96 hours; black bullhead at 10% virus
    product showed no effect at 10 ppm; rainbow trout at 10% virus
    product resulted in 100% mortality in test solutions containing
    greater than 10 ppm concentrations after 96 hours; white sucker and
    black bullhead showed no effect at 70 ppm after 96 hours.
  - To address the ecological hazards, the Agency is requiring that the
    test results from all of the Tier I non-target organism tests, as
    noted in the current guidelines, be submitted in support of
    registration or reregistration of all products containing the active
    ingredient Heliothis zea.


- Tolerance Assessment

Tolerance exemption assessments as per 40 CFR 180.1027:  Exemptions
from the requirement of a tolerance are established for the residues
of the microbial insecticide nuclear polyhedrosis virus of Heliothis
zea, in or on all raw agricultural commodities including:  corn,
cottonseed, beans, lettuce, okra, peppers, sorghum, soybeans, tobacco,
and tomatoes.


- Summary Science Statement

  - Heliothis zea NPV does not appear to be toxic to man or animal; it
    does not appear to have any deleterious effects on the environment.
    Heliothis zea NPV has 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 Heliothis
    zea NPV to wildlife.  From the available data, limited exposure to
    large animals, estuarine/marine organisms, and freshwater organisms
    is expected as a result of the current label uses.


         4.  SUMMARY OF REGULATORY POSITION AND RATIONALE

Because all Helioth1s zea products were registered under the
conventional pesticides data requirement guideline before the
promulgation of the current biorational guidelines, the Agency is
requiring that all product analysis data be submitted as in Tier I of
the biorational data guidelines, as well as most Tier I data for
Ecological Effects.


                      5.  SUMMARY OF MAJOR DATA GAPS

- The data requirements represent major data gaps for Heliothis NPV.
  These data are required to be submitted to the Agency within 2 years
  from the date of the issuance of the registration document.
- Tier I 158.165 Non-target Organisms
  - Primary dermal study - Avian oral toxicity study
  - Wild mammal study
  - Freshwater fish study
  - Freshwater aquatic invertebrate study
- Estuarine/marine animal testing study
- Plant studies
- Non-target insect study
- Honeybee testing study
- Product analysis data


                             6.  CONTACT PERSON AT EPA

Timothy A. Gardner
Product Manager (PM) 17
Registration Division (TS-767C)
Office of Pesticide Programs
Environmental Protection Agency
401 M St., SW
Washington, DC  20460

Office location and telephone number:
Room 202, CM #2
1921 Jefferson Davis Highway
Arlington, VA  22202
(703) 557-2690


DISCLAIMER:
THE INFORMATION PRESENTED IN THIS CHEMICAL INFORMATION FACT SHEET IS FOR 
INFORMATIONAL PURPOSES ONLY AND NOT TO BE USED TO FULFILL DATA 
REQUIREMENTS FOR PESTICIDE REGISTRATION AND REREGISTRATION.