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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


Pesticide Reregistration

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 
stringent standards.

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
NPV.


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:

Beans           Soybeans
Corn            Strawberries
Cotton          Tobacco
Lettuce         Tomatoes
Peanuts         Wild Clover
Sorghum         Wild Geraniums


Regulatory History

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.

Health Effects

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 
appropriate.

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 
its production.

     During Application
Due to its low toxicity and its use pattern, Heliothis zea NPV poses no known 
risks to applicators.


Environmental Hazards

     Environmental Fate
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.

     Ecological Effects
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 
nontarget insects.

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 
are required.


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.


Regulatory Conclusion 

- 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-
557-1884.

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 
#PB85134393.

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-
3094.