&EPA
United States
Environmental Protection
Agency
Prevention, Pesticides
And Toxic Substances
(7508W)
EPA-738-F-96-020
September 1996
Pesticide
Reregistration
Use Profile
R.E.D. FACTS
Polyhedral Inclusion Bodies of
Gypsy Moth (Lymantria dis par)
and Douglas Fir Tussock Moth
(Orgyia pseudotsugata) Nuclear
Polyhedrosis Viruses
All pesticides sold or distributed 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 before November 1, 1984, be
reregistered to ensure that they meet today's more stringent standards.
In evaluating pesticides for reregistration, EPA obtains and reviews a
complete set of studies from pesticide producers, describing the human
health and environmental effects of each pesticide. The Agency develops
any mitigation measures or regulatory controls needed to effectively reduce
each pesticide's risks. EPA then reregisters pesticides that can be used
without posing unreasonable risks to human health or the environment.
When a pesticide is eligible for reregistration, EPA explains the basis
for its decision in a Reregistration Eligibility Decision (RED) document.
This fact sheet summarizes the information in the RED document for
reregistration case 4106, Polyhedral inclusion bodies of gypsy moth
(Lymantria dispar) and Douglas fir tussock moth (Orgyiapseudotsugata)
nuclear polyhedrosis viruses, also referred to as PIBs of LdNPV and
OpNPV.
Polyhedral inclusion bodies of gypsy moth (Lymantria dispar) and
Douglas fir tussock moth (Orgyiapseudotsugata) nuclear polyhedrosis
viruses, PIBs of LdNPV and OpNPV, are viral insecticides used to control
gypsy moth and Douglas fir tussock moth on Forest Trees.
PIBs of LdNPV are used on: oak, hickory, basswood, birch, cherry,
elm, blackgum, larch, sassafras, hemlock, cedar, spruce, black walnut,
American chestnut, willow, poplar, ash, box elder, hawthorn, butternut,
catalpa, American holly, locust, and sycamore.
PIBs of OPNPV are used on: Douglas fir, true fir, willow , and cedar.
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Regulatory
History
Formulations include for PIBs of LdNPV: wettable powder, soluble
concentrate, and flowable concentrate, and for PIBs of OpNPV, the
formulation is wettable powder.
PIBs of LdNPV and OpNPV are applied by aerial spray from aircraft.
Use practice limitations: PIBs of LdNPV and OpNPV are limited to
wide-area government sponsored programs to control gypsy moth and
Douglas fir tussock moth on forest trees. Only non-food uses are permitted
by labeling.
PIBs of OpNPV were first registered as a viral insecticide in the U.S.
in August, 1976. During Phase 4 of the Reregi strati on Process, the
database for PIBs of OpNPV was evaluated and determined to be
inadequate in satisfying certain data requirements for microbial pest control
agents (MFCAs). In September 1993, a Data Call-In (DCI) required
additional ecological effects data to fill data gaps: Avian oral
toxicity/pathogenicity in quail and duck; freshwater fish
toxicity/pathogenicity in trout; freshwater invertebrate
toxicity/pathogenicity in benthic organism; nontarget plant; nontarget insect
toxicity/pathogenicity; and honey bee toxicity/pathogenicity.
Based on the 90-day response to the DCI and additional publicly
available literature provided by the USFS, the Agency determined the
following: 1) the data requirements had been acceptably met for 154A-23
Nontarget insect tox/path and 154A-24 Honey bee tox/path, and 2) data
requirements should be waived for 154A-16a Avian oral path/tox~quail,
154A-16b Avian oral path/tox~duck, 154A-19a Freshwater fish tox/path—
trout, 154A-20 Freshwater invertebrate tox/path~benthic. The only
remaining outstanding data requirement was for 154A-22 Nontarget plant
studies. During the analysis and development of the reregi strati on
eligibility decision (RED), wherein the databases for OpNPV and LdNPV
were combined, the data requirement of non-target plant studies was
reexamined and waived because of the absence of toxicity in the "bridged"
data set. OpNPV appears to not cause adverse effects on avian,
mammalian, aquatic, insect and plant wildlife.
PIBs of LdNPV were first registered as a viral insecticide in the U.S.
in April 1978. During Phase 4 of the Reregi strati on Process, the database
for PIBs of LdNPV was evaluated and determined to be inadequate in
satisfying certain data requirements for microbial pest control agents
(MPCAs). In September 1993, a Data Call-In (DCI) required additional
ecological effects data to fill data gaps: freshwater fish
toxicity/pathogenicity in trout; freshwater invertebrate
toxicity/pathogenicity in benthic organism; nontarget plant; nontarget insect
toxicity/pathogenicity; and honey bee toxicity/pathogenicity.
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Human Health
Assessment
Based on the 90-day response to the DCI and publicly available
literature, the Agency determined that the data requirements for 154A-19a
Freshwater fish tox/path—trout, 154A-20 Freshwater invertebrate tox/path—
benthic, 154A-22 Nontarget plant studies, 154A-23 Nontarget insect
tox/path, and 154A-24 Honey bee tox/path may be waived. During the
analysis and development of the reregi strati on eligibility decision (RED),
wherein the databases for OpNPV and LdNPV were combined, these data
requirements were reexamined in the "bridged" data set, and their waiver
confirmed. LdNPV appears to not cause adverse effects on avian,
mammalian, aquatic, insect and plant wildlife.
Currently, one product that has PIBs of OpNPV as the active
ingredient is registered: TM Biocontrol-l4"1; two products that have PIBs of
LdNPV as the active ingredient are registered: Gypchek"11 and Lymantrin
Insecticide tm.
Toxicity
In studies using laboratory animals, PIBs of OpNPV and LdNPV have
generally been shown to be of low acute toxicity with the exception of
primary eye irritation. Acute oral, acute pulmonary, and primary dermal
irritation toxicity studies indicate Toxicity Category IV, the lowest of four
Categories, and "practically non-toxic." The LD50 for acute oral toxicity is
> 5g/kg. Acute dermal has a LD50 > 3.16 g/kg, a Toxicity Category III
second lowest of the four Toxicity Categories and is characterized as
"slightly toxic." However, primary eye irritation studies (perhaps because
of the presence of larval hairs, microbial contaminants, or other inerts that
currently are found with the active ingredient) demonstrate irreversible
corneal damage, which warrants a Toxicity Category I, the highest toxicity
rating that indicates the pesticide is "very highly or highly toxic."
Dietary Exposure
Since PIBs of OpNPV and LdNPV are applied to forested areas, the
Agency considers these non-food uses which do not require a tolerance.
Any exposures to wild food plants or adjacent croplands are incidental to
the intended use and are not expected to present a significant dietary
exposure. Given the lack of adverse effects presented by existing
mammalian toxicological data, there is not reason to expect any dietary
risks from residues of the NPVs in these incidental exposures.
Occupational and Residential Exposure
Based on spraying and aerial application methods that are used, the
potential for dermal, eye and inhalation exposures to the pesticide exists.
Because of the lack of human pathogenicity demonstrated by the test results
on hand and the absence of reports of adverse human health effects after 20
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years of manufacture and use of the AIs, worker exposure data on the active
ingredients are not required.
However, due to the Acute Dermal response (Toxicity Category III)
and reports in the published literature of dermal sensitivity to the larval
hairs of the host species, the Agency will require product precautionary
label statements that include proper warning about the presence of insect
parts being a potential dermal sensitizer and the use of personal protective
equipment. These label statements are necessary until proper quality
control procedures are documented to reduce the likelihood that significant
levels of insect hairs are present in the product.
In the eye irritation studies submitted to date, several animals in each
test have shown corneal effects which did not clear by the end of the 14 day
observation period. These results require that the labels have a toxicity
rating of Toxicity Category I as a severe eye irritant. Although it was
subsequently shown that the eye irritation was not associated with the virus
particles themselves, nevertheless, until an acceptable eye irritation study is
submitted to show otherwise, label statements are required that indicate the
products are severe eye irritants and that specify appropriate eye protection.
Human Risk Assessment
For PIBs of OpNPV and LdNPV, applications of the insecticides are
not expected to result in exposure and risk to workers. Potential exposures
during mixing, loading, and spraying will be mitigated by compliance with
the labeling requirements and use of personal protective equipment (PPE)
as specified by this RED.
Environmental
Assessment
Environmental Fate
Naturally occurring PIBs of OpNPV and LdNPV are important in
bringing about the epizootic collapse of gypsy moth and Douglas fir
tussock moth populations. Environmental fate studies indicate that collapse
of the pest populations release a much greater amount of PIBs of OpNPV
and LdNPV into the environment than their applications as a biopesticide;
the natural levels of PIBs of OpNPV and LdNPV are not increased
significantly by applications of the biopesticides. These data support the
conclusion that PIBs of LdNPV and OpNPV are natural components of the
hosts' environment and that pesticidal uses would not raise their levels
above the range that naturally occurs.
Ecological Effects
The applications of aerially applied PIBs of OpNPV and LdNPV to
forest ecosystems can be expected to result in exposure to a wide variety of
birds, mammals, fish, aquatic invertebrates, and non-target insects.
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Submitted studies, the scientific literature, target host specificity, and
twenty years of use as biopesticides for controlling Douglas fir tussock
moth and gypsy moth indicate no adverse effects on nontarget wildlife,
including endangered species.
Risk Mitigation
Additional Data
Required
Product Labeling
Changes
Required
Ecological Effects Risk Assessment
No environmental or ecological toxicity data requirements are being
required for PIBs of OpNPV and LdNPV in this RED. All data indicate
that risks to non-target organisms are either non-existent or minimal.
Until acceptable justifications and studies are submitted that show
risks to be negligible, EPA is requiring modifications to the precautionary
label statements for PIBs of OpNPV and LdNPV to protect against possible
risk of dermal toxicity and eye irritation. See "Product Labeling Changes
Required" below.
EPA is not requiring additional generic studies for PIBs of OpNPV
and LdNPV to confirm its regulatory assessments and conclusions.
For reregi strati on of products containing the AIs of PIBS of OpNPV
and LdNPV, the Agency is requiring product-specific data including
product chemistry and acute toxicity studies, revised Confidential
Statements of Formula (CSFs), and revised labeling for reregi strati on.
In the evaluation of the toxicological data base for PIBs of OpNPV
and LdNPV, EPA determined that the AIs are severe eye irritants and thus
require labels specifying appropriate eye protection. The Toxicity Category
I for primary eye irritation requires products containing the AIs to be
labeled with the signal word "Danger" and the appropriate Statements of
Precaution, Personal Protective Equipment, Practical Treatment, and Note
to Physician.
In addition, because of acute dermal response and reports in the
published literature of dermal sensitivity to the larval hairs of the host
species that contaminate the AIs, the Agency determined that the AIs have
Toxicity Category III for acute dermal sensitivity. The EPA will require
product precautionary label statements that include proper warning about
the presence of insect parts being a potential dermal sensitizer and
appropriate Statements of Precaution, Personal Protective Equipment, and
Practical Treatment.
End-use products must comply with EPA's current pesticide product
labeling requirements. For a comprehensive list of labeling requirements,
please see the Polyhedral Inclusion Bodies of Gypsy Moth and Douglas Fir
Tussock Moth Nuclear Polyhedrosis Viruses RED document.
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Changes in the end use product labeling requirements specified in
Chapter V of the RED are as follows:
"Avoid contact with skin, eyes or clothing, Wash thoroughly with
soap and water after handling. Wear long-sleeved shirt and long
pants, socks, shoes, and protective gloves. Prolonged or frequently
repeated skin contact may cause allergic reactions in some
individuals."
For eye irritation, label products with the signal word: "Danger."
Statements of Precaution and Personal Protective Equipment:
"Primary eye irritation studies indicate pesticide is a severe eye
irritant and may cause irreversible eye damage. An emergency eye
flushing apparatus shall be present where mixing/loading take place.
Do not get in eyes or on clothing. Wear goggles or face shield. Wash
thoroughly with soap and water after handling. Remove
contaminated clothing and wash clothing before reuse."
Statement of Practical Treatment: "If in eyes: hold eyelids open and
flush with a steady, gentle stream of water for 15 minutes. Get
medical attention."
Note to Physician: "Product is a severe eye irritant, possibly causing
irreversible damage to cornea."
Statement for aerial spraying: "Avoid spraying sensitive populated
areas. This pesticide must be applied in a manner to avoid spraying—
either directly or indirectly through drift—sites such as residential
areas, schools, playgrounds, or similar sites where people or pets may
be present."
The use of currently registered products containing PIBs of OpNPV
Conclusion an^ LdNPV in accordance with approved labeling in the RED will not pose
unreasonable risks or adverse effects to humans or the environment.
Therefore, all uses of these products are eligible for reregi strati on.
PIBs of OpNPV and LdNPV products will be reregistered once the
required product-specific data, revised Confidential Statements of Formula,
and revised labeling are received and accepted by EPA.
For MOTG EPA is requesting public comments on the Reregi strati on Eligibility
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Information Decision (RED) document for Polyhedral Inclusion Bodies of Gypsy Moth
and Douglas Fir Tussock Moth Nuclear Polyhedrosis Viruses during a 60-
day time period, as announced in a Notice of Availability published in the
Federal Register. To obtain a copy of the RED document or to submit
written comments, please contact the Pesticide Docket, Public Response
and Program Resources Branch, Field Operations Division (7506C), Office
of Pesticide Programs (OPP), US EPA, Washington, DC 20460, telephone
703-305-5805.
Electronic copies of the RED and this fact sheet can be downloaded
from the Pesticide Special Review and Reregi strati on Information System
at 703-308-7224. They also are available on the Internet on EPA's gopher
server, GOPHER.EPA.GOV, or using ftp on FTP.EPA.GOV, or using
WWW (World Wide Web) on WWW.EPA.GOV.
Printed copies of the RED and fact sheet can be obtained from EPA's
National Center for Environmental Publications and Information
(EPA/NCEPI), PO Box 42419, Cincinnati, OH 45242-0419, telephone
513-489-8190, fax 513-489-8695.
Following the comment period, the Polyhedral Inclusion Bodies of
Gypsy Moth and Douglas Fir Tussock Moth Nuclear Polyhedrosis Viruses
RED document also will be available from the National Technical
Information Service (NTIS), 5285 Port Royal Road, Springfield, VA
22161, telephone 703-487-4650.
For more information about EPA's pesticide reregi strati on program,
the RED Polyhedral Inclusion Bodies of Gypsy Moth and Douglas Fir
Tussock Moth Nuclear Polyhedrosis Viruses , or reregi strati on of individual
products containing PIBs of OpNPV and LdNPV, please contact the
Biopesticides and Pollution Prevention Division (7501W), OPP, US EPA,
Washington, DC 20460, telephone 703-308-8712.
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, between 9:30 am and 7:30 pm Eastern Standard
Time, Monday through Friday.
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