heliothis zea NPV (Heliothis) EPA R.E.D. Facts 1/91
United States Environmental Protection Agency
Pesticides And Toxic Substances (H- 7508W)
21T-1002, January 1991
EPA R.E.D. FACTS
Heliothis Zea NPV
All pesticides sold or used in the United States must be registered by EPA,
based on scientific studies showing that they can be used without posing
unreasonable risks to people or the environment. Because of advances in
scientific knowledge, the law requires that pesticides which were first
registered years ago be reregistered to ensure that they meet today's more
In evaluating pesticides for reregistration, EPA obtains from pesticide
producers and reviews a complete set of studies showing the human health and
environmental effects of each pesticide. The Agency imposes any regulatory
controls that are needed to effectively manage each pesticide's risks. EPA
then reregisters pesticides that can be used without posing undue hazards to
human health or the environment.
When a pesticide is eligible for reregistration, EPA announces this and
explains why in a Reregistration Eligibility Document, or RED. This fact sheet
summarizes the information in the RED for Heliothis zea
Heliothis zea NPV
Heliothis zea nuclear polyhedrosis virus (Heliothis zea NPV), which is sold
under the trade name Elcar, is a microbial insecticide made from a naturally-
occurring virus of the cotton bollworm and tobacco budworm. It infects only
organisms belonging to the genus Heliothis. It is used to control a variety of
worms including the cotton bollworm, tomato fruitworm, soybean podworm,
sorghum headworm, corn earworm and tobacco budworm.
The one registered product containing Heliothis zea NPV is sold as a wettable
powder and is applied as a foliar spray. It is registered for use on the
following crops, and all of these uses are eligible for reregistration:
Peanuts Wild Clover
Sorghum Wild Geraniums
Heliothis zea NPV was first registered by EPA in 1975 for use on cotton and
tobacco, to control the cotton bollworm and the tobacco budworm. EPA issued a
Registration Standard for Heliothis zea NPV in June 1984.
Heliothis zea NPV is a microbial pesticide, and its health-related data base
consists mainly of a group of screening studies designed to show the toxicity
and infective properties of the virus. If these studies indicated potential
adverse effects, further studies on environmental fate, ecological effects and
food residues would be required.
The results of these screening tests and other available studies on Heliothis
zea NPV indicate that it is virtually innocuous to people, wildlife and other
non-target organisms. Therefore, no additional, environmental fate and residue
data are being required.
Heliothis zea NPV caused no adverse effects in any acute oral, dermal,
inhalation or intravenous toxicity test. Nor is the pesticide an eye irritant.
It is, therefore, being placed in toxicity category IV (the least toxic
category). Other studies show that Heliothis zea NPV will not replicate or
infect mammals, and does not cause birth defects.
Several special toxicology studies on Heliothis zea NPV also were available to
EPA. Heliothis zea NPV caused no adverse effects in these subchronic feeding
and inhalation studies, in an oncogenicity study, a Rhesus monkey study, a
developmental toxicity study, and even in a voluntary human feeding study.
Routes Of Exposure
Through the Diet
Heliothis zea NPV is used in growing several food crops, and residues of the
pesticide could remain on food and animal fed. However, since the screening
level and other studies show that it causes no toxic effects, no tolerances
(or legal residue limits) have been established for Heliothis zea NPV. An
exemption from the requirement of a tolerance was established for residues of
Heliothis zea NPV on all agricultural commodities in 1980. After thoroughly
reviewing and reassessing the available studies and literature on Heliothis
zea NPV, EPA still believes that residue data are not needed for this
microbial pesticide and that the existing tolerance exemption continues to be
To update the terminology and better reflect current technology, EPA is
proposing to amend the terms of the tolerance exemption for Heliothis zea NPV
as set forth in the Code of Federal Regulations (40 CFR 180.1027). These
changes will more clearly define the virus and will add specifications for
Due to its low toxicity and its use pattern, Heliothis zea NPV poses no known
risks to applicators.
No environmental fate studies are required to support the reregistration; of
Heliothis zea NPV, since no toxic or pathogenic effects have been observed in
the screening level ecological effects data for this microbial pesticide.
The available studies and other relevant information show that Heliothis zea
NPV does not cause adverse effects on birds or fish. Due to its narrow host
range, this pesticide does not harm honeybees or pose a significant risk to
Since Heliothis zea NPV poses a minimal to non-existent risk to nontarget
wildlife due to its narrow host range, no further ecological effects studies
Additional Data Required
No additional generic or product-specific data are required for
reregistration of Heliothis 7 NPV.
Product Labeling Changes Required
So that it will meet current pesticide labeling requirements, the Heliothis
zea NPV product label must be amended to include a water contamination warning
and a more accurate, updated ingredients statement. Please see the
Reregistration Eligibility Document for more detailed information on these
required labeling changes.
- Based on the studies available to EPA, Heliothis zea NPV appears to cause
virtually no adverse effects in people, wildlife, or nontarget insects. Due
to its narrow host range, this microbial pesticide poses a threat only to the
insects that it is intended to control.
- EPA has sufficient data on Heliothis zea NPV to conduct a reasonable risk
assessment and to determine that the pesticide can be used without causing
unreasonable adverse effects in people or the environment. Therefore, Elcar,
the only registered pesticide product containing Heliothis zea NPV, is
eligible for reregistration. This product will be reregistered once revised
labeling is submitted to and accepted by EPA.
For More Information
EPA will accept and consider public comments on the Reregistration Eligibility
Document for Heliothis zea NPV for several months. To obtain a copy, or to
submit written comments, please contact the Public Response and Program
Resources Branch, Field Operations Division (H- 7506C), Office of Pesticide
Programs, U.S. EPA, Washington, D.C. 20460. Call 703-557-4436, or fax to 703-
To obtain a copy of the Registration Standard for Heliothis zea NPV, please
contact the National Technical Information Service (NTIS), 5285 Port Royal
Road, Springfield, VA. 22161. Call 703-487-4650, and request document
For more information about Heliothis & NPV or EPA's pesticide reregistration
program, please contact the Special Review and Reregistration Division (H-
7508W), Office of Pesticide Programs, U.S. EPA, Washington, D.C. 20460. Call
703-308-8000, or fax your request to 703-308-8005.
For information about the health effects of pesticides, or for assistance in
recognizing and managing pesticide poisoning symptoms, please contact the
National Pesticides Telecommunications Network (NPTN). Call toll-free 1-800-
858-7378, 24 hours a day, seven days a week, or fax your inquiry to 806-743-