Registration Decision for the New Active Ingredient 

Spodoptera exigua multinucleopolyhedrovirus 

strain BV -0004 

usenger, Director 

ffice of Pesticide Programs 

Da te: 

/J. -J.- 1~ 
1. Background 

On October 25,2013, the U.S. Environmental Protection Agency (EPA) received an application 

for registration for the new insecticide active ingredient Spodoptera exigua 

multinucleopolyhedrovirus strain BV-0004 from Sci Reg Inc., on behalf of Andermatt Biocontrol 

AG, a Swiss company. Subsequently, SciReg provided additional data on this active ingredient 

and its end-use product (EP), Spexit, to the EPA. The applicant was not required to submit a 

petition for a tolerance or an exemption from the requirement of a tolerance for residues of the 

active ingredient on food crops because the new active ingredient is covered by an existing 

tolerance exemption ( 40 CFR Part § 180.1118) for occlusion bodies of the nuclear polyhedrovirus 

of Spodoptera exigua. After reviewing these data, the EPA concluded that the use of the 

pesticide EP, Spexit, will not cause any unreasonable adverse effects on the environment. On 

October 23,2015, EPA proposed to register the active ingredient Spodoptera exigua 

multinucleopolyhedrovirus strain BV -0004 and afterwards released that decision for a 15-day 

public comment period. EPA received no public comments on that decision. 

Therefore, the Agency is registering the EP containing the new active ingredient under FIFRA 

section 3(c)(5) for the following labeled uses: tomatoes, lettuce, cucumbers, peppers, sweet corn, 

broccoli, cauliflower, cabbage, peas, beets, celery, onions, asparagus, okra, strawberries, melon, 

eggplant, ornamentals. flowers. cotton, alfalfa, soybeans. peanuts, potatoes, corn, wheat, rice, 

sweet potatoes, tobacco, sunflowers, sugar beets, sorghum, flax, grapes, beans, escarole, garlic, 

leek, floriculture, and border plants. 

The active ingredient in the EP, Spodoptera exigua multinucleopolyhedrovims strain BV-0004, 

is a virus specific to Spodoplera exigua, more commonly known as the Beet armyworm, and is a 

member of the virus family Baculoviridae. Spodoptera exigua nucleopolyhedrovirus strain BV0004 is a naturally-occurring, non-genetically modified strain originally isolated from S. exigua 

larvae in China. It was deposited at the German Collection for Microorganisms and Cell Cultures 

(DSMZ) in 2006 under the accession number BV-0004. Spodoptera exigua 

multinucleopolyhedrovirus strain BV-0004 acts very specifically against larvae of the Beet 

armyworm. After the larva ingests it, the virus rapidly multiplies within the host insect, resulting 

in cell destruction and death, typically within three to seven days. 

Baculoviruses have been used as pesticides for many years without posing risks to human health 

or the environment. The species, Spodoptera exigua multinucleopolyhedrovirus (SeMNPV), was 

isolated in different locations throughout the world. In 1995 the EPA registered as a pesticide a 

strain isolated in Florida under the trade name Spod-X (EPA Reg. No. 70051 -46). After 20 years 

of use in the United States and around the world, there is no evidence of safety concerns for 

workers or of risks to human health and the environment from the labeled uses of this pesticide. 

When researchers used DNA restriction endonuclease analysis to compare the genetic material of 

the strains in Spexit to the strains in Spod-X, the results showed that the pattern of Spexit is 

nearly identical to the pattern of Spod-X. The genomes are estimated to be more than 93% 

identical. 

Spexit is for agricultural use in the United States in greenhouses and field applications to control 

the Beet armyworm on a wide variety of food and non-food crops, and it is to be applied by 

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ground or aerial spray or by chemigation. In addition, this product includes a sub-label to control 

the same insect pest on fruits, vegetables, and flowers in home gardens. Since the active 

ingredient in Spexit is covered by an existing tolerance exemption, a new petition was not 

required. 

2. Evaluation 

In evaluating a pesticide registration application, the EPA assesses a wide variety of studies to 

determine the likelihood of adverse effects (i.e., risk) from exposures associated with the use of 

the product. Risk assessments are developed to evaluate how the compound might affect a wide 

range of nontarget organisms, including humans and terrestrial and aquatic wildlife (plants and 

animals). 

Based on these assessments, the EPA evaluates and approves language for each pesticide label to 

ensure the directions for use and safety measures are appropriate to mitigate any potential risk. In 

this way, the pesticide's label helps to communicate essential limitations and mitigations that are 

necessary for public safety. In fact, the pesticide law has a provision that indicates it is a 

violation to use a pesticide in a way that conflicts with the label. 

2.1 Assessment of Risk to Human Health 

In order to assess a microbial pesticide's risk to human health, the EPA initially requires a wide 

range of studies, including Tier I acute toxicity/pathogenicity (oral, pulmonary, and injection) 

data, cell culture data, reports of hypersensitivity incidents, acute toxicity (oral, dermal, and 

inhalation) data, and irritation (dermal and eye) data. Tier II and III testing (e.g., subchronic 

toxicity/pathogenicity) is triggered only when there is indication, usually through lower tier 

testing, that a microbial pesticide has unusual toxicological characteristics, such as infectivity or 

being suspected as or known to be a carcinogen. 

2.1.1 Toxicity 

For Spodoptera exigua multinucleopolyhedrovirus strain BV-0004, the database of studies 

required to support the assessment of risk to human health is complete. The toxicity tests (acute 

oral, dermal, and inhalation toxicity) and irritation tests (acute eye and primary dermal irritation) 

that were conducted using the EP, Spexit, and addressed potential routes of exposure to the 

active ingredient are all classified in Toxicity Category IV and reveal little to no toxicity or 

irritation attributed to Spodoptera exigua multinucleopolyhedrovirus strain BY -0004. Moreover, 

during a typical toxicity/pathogenicity test done with microbial pesticides, the active ingredient 

did not produce any signs of acute toxicity, pathogenicity, or infectivity via the pulmonary route 

of exposure. For the other routes of exposure, the applicant met the data requirements by citing 

existing studies and providing scientific rationale. The rationale cited the results of other 

toxicological data on other species of Spodoptera. In addition, the applicant submitted a 

literature search that yielded no human pathogenicity concerns and data describing the specificity 

of the virus to the target insect species. 

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The EPA also determined that there are sufficient data to satisfy the requirement of cell culture 

testing without requiring the submission of a study because of the similarity of the new active 

ingredient to other members of the baculovirus family that were registered many years ago. 

Previously, the Agency had concluded in the Heliothis zea Reregistration Eligibility Document 

that "due to the overall results of Tier ffi toxicology testing and the additional toxicology data 

which support the negative response of viral replication in mammals, there are sufficient data to 

satisfy this requirement without requesting a cell culture study." Since the Spodoptera and 

Heliothis genera are so closely related, this conclusion applies to this new strain of Spodoptera 

exigua. Finally, the applicant reported that, to date, no hypersensitivity incidents have occurred 

during research, development, and testing of this insect virus. In light of the adequacy of the 

toxicological data, scientific rationale, and literature provided by the applicant and the absence of 

hypersensitivity incidents, the EPA did not require toxicological testing at higher tiers. 

2.1.2 Aggregate and Occupational Exposure 

In examining aggregate exposure, section 408 of FFDCA directs the EPA to consider 

available information concerning exposures from the pesticide residue in food and all other 

nonoccupational exposures, including drinking water from ground water or surface water and 

exposure through pesticide use in gardens, lawns, or buildings. 

Food Exposure and Risk Characterization: The EPA found that increased dietary exposure to 

Spodoptera exigua multinucleopolyhedrovirus strain BY -0004 from its use on food crops is 

unlikely. Due to the ubiquitous nature of this naturally occurring insect virus and the 

concentrations of this virus and other closely related viruses that already exist in the 

environment, the likelihood of increased risk to humans or animals from the use of Spexit is low. 

Furthermore, because the virus degrades rapidly when exposed to ultraviolet light and during 

food harvesting and processing, exposure to the virus would be minimal. The EPA concluded 

that the risk posed to adults, infants, and children is likely to be minimal because of the low acute 

oral toxicity/pathogenicity potential of Spodoptera exigua multinucleopolyhedrovirus strain BV0004. 

Drinking Water Exposure and Risk Characterization: Exposure to residues of Spodoptera exigua 

multinucleopolyhedrovirus strain BV-0004 in consumed drinking water is unlikely. The use 

patterns for Spexit are soil directed and/or soil incorporated, thereby limiting contact with 

surface water by drift and runoff. Furthermore, ground water is not expected to have significant 

exposure to the virus since, like other microorganisms, this microbial pesticide would likely be 

filtered out by the particulate nature of many soil types. If it were to be transferred to surface or 

ground waters that are intended for eventual human consumption (e.g., through spray drift or 

runoff) and directed to wastewater treatment systems or drinking water facilities, it is unlikely 

that the virus would survive the conditions water is subjected to in such systems or facilities, 

including chlorination, pH adjustments, filtration, and/or occasionally high temperatures. In the 

remote likelihood that Spodoptera exigua multinucleopolyhedrovirus strain BV-0004 is present 

in drinking water (e.g., water not subject to treatment systems or facilities), its target pest 

specificity and available data indicate no toxicity or pathogenicity is likely to occur with any 

drinking water exposure that results from pesticide applications made in accordance with good 

agricultural practices. 

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Non-occupational. Residential Risk Characterization: Given that Spodoptera exigua 

multinucleopolyhedrovirus strain BV -0004 is naturally-occurring and usually not stable outside 

of its insect host, non-occupational exposure to the virus is unlikely. Repeated exposures to the 

microorganism from pesticidal applications do not exceed EPA's level of concern, particularly in 

light of available data that demonstrate that the virus is not toxic (acute dermal toxicity and acute 

pulmonary toxicity/pathogenicity), non-irritating (primary dermal irritation), and not pathogenic 

(acute pulmonary toxicity/pathogenicity). 

Occupational Exposure: The EPA expects occupational exposure to Spodoptera exigua 

multinucleopolyhedrovirus strain BV -0004 to be low, as long as applicators follow precautions 

on product labels. The Agricultural/Commercial-Use product label for Spexit requires 

applicators to wear long sleeved shirts and pants, water proof gloves, shoes plus socks, and a 

NIOSH approved particulate respirator with any R or P filter with NIOSH approval number 

prefix TC-84A, or a NIOSH approved powered air purifying respirator with an HE filter with 

NIOSH approval number prefix TC-21 C. Repeated exposure to high concentrations of microbial 

proteins can cause allergic sensitization. These precautions ensure that applicators will not 

develop an allergic sensitization to the active ingredient in the product. Furthermore, even if 

workers are exposed to the active ingredient in Spexit, toxicity testing on this new strain of the 

virus and nearly identical strains demonstrate that there is a low risk to human health including 

allergic sensitization. 

2.1.3 Human Health Conclusion 

The EPA concludes that there is a reasonable certainty that no ham1 will result to the U.S. 

population, including infants and children, from aggregate exposure to residues of Spodoptera 

exigua multinucleopolyhedrovirus strain BV-0004. The EPA does not expect dietary (food and 

drinking water) or other non-occupational risks from use of this virus as an active ingredient in 

the pesticide product. Although exposure to Spodoptera exigua multinucleopolyhedrovirus strain 

BV-0004 through consumed food and drinking water is possible, the EPA anticipates these types 

of exposures may be reduced because, among other things, this insect virus is highly specific to 

target insect pests and is not persistent in the environment, and typical processing procedures 

(e.g., peeling and/or additions of sugar, salt, and other preservatives) could remove the microbe 

from commodities. Should Spodoptera exigua multinucleopolyhedrovirus strain BV-0004 be 

present in or on food, in drinking water, or in residential settings, supporting toxicological 

information indicates that human exposure to this virus would not result in adverse effects. In 

addition, Spodoptera exigua multinucleopolyhedrovirus strain BV-0004 is covered by the 

existing exemption from the requirement of a tolerance for residues of Spodoplera exigua 

multinucleopolyhedrovirus on all agricultural commodities ( 40 CFR § 180.11 18). The EPA is not 

required to amend the existing tolerance exemption. 

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2.2 Assessment of Ecological Exposure and Risk 

In order to assess a microbial pesticide's risk to the environment, the EPA initially requires a 

wide range of studies, including Tier J testing done on the following nontarget organisms: birds 

(oral and inhalation), mammals, freshwater fish and invertebrates, estuarine/marine fish and 

invertebrates, plants, insects, and honeybees. Higher tier testing (II, Ill. and IV) generally 

encompasses definitive hazard determinations and longer term greenhouse or field testing and is 

implemented only when unacceptable effects are seen at the Tier I screening level. For the active 

ingredient Spodoptera exigua multinucleopolyhedrovirus strain BV -0004, the database of studies 

and information required to support the assessment of risk to the environment is complete. 

The EPA expects exposure of nontarget organisms to Spodoptera exigua 

multinucleopolyhedrovirus strain BV-0004 to be minimal. Based on data and other information 

provided by the applicant, the Agency determined that adverse effects to nontarget organisms are 

not anticipated from the labeled uses of Spexit, the end use product containing this active 

ingredient. These nontarget species include mammals, birds, terrestrial and aquatic plants, 

freshwater and marine/estuarine animals, and insects. In the case of nontarget insects, the 

applicant submitted a scientific rationale that provides a weight-of-evidence justification (based 

on information and data from the current open literature) that there will be no risks to the 

nontarget insect populations because the virus is highly specific to the target insect pest. 

Similarly, the applicant submitted a scientific rationale providing a weight-of-evidence 

justification that exposures of the new strain of the virus to honeybee populations are not likely 

to cause adverse effects because of the virus' monospecific nature. In addition, baculovirus 

insecticides have a limited activity in the environment because oftheir sensitivity to sunlight and 

ultraviolet radiation. 

The EPA made a "No Effect" determination for direct and indirect effects to federally listed 

endangered and threatened (" listed") species and for their designated critical habitats from 

exposure to Spodoptera exigua multinucleopolyhedrovirus strain BV-0004. Spodoptera exigua 

multinucleopolyhedrovirus is known to be highly specific to its host, Spodoptera exigua larvae, 

as a result of a relationship that has evolved over the past 400 to 500 million years. Because it is 

specific to this host, the virus is not going to infect other species, such as nontarget insects, that 

may be exposed to the virus. Furthermore, exposure of nontarget organisms to this virus is 

expected to be minimal because it only persists on plants for a short period of time, and the virus 

is likely to degrade when exposed to sunlight. Hence, nontarget species will not be adversely 

affected by this insect virus from its use as labeled, and the virus poses no risk to "listed" 

spec1es. 

3. Alternatives 

The use of this microbial insecticide could reduce the use of conventional insecticides in 

commercial agriculture and residential gardening. The EP, Spexit, has the potential to replace 

many conventional insecticides on the market today that are used to combat the Beet armyworm. 

The active ingredients in these conventional pesticide products are malathion, chlorpyrifos, 

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methomyl, diflubenzuron, profenofos, thiodicarb, and bifenthrin. Growers and gardeners may 

use Spodoptera exigua multinucleopolyhedrovirus strain BV-0004 as an alternative to these 

conventional insecticides or in conjunction with other biopesticides in an Integrated Pest 

Management (IPM) program. Among other things, Spodoptera exigua 

multinucleopolyhedrovirus strain BV-0004 will have an established exemption from the 

requirement of a tolerance (no limitations) for all food commodities. In addition, the EP has a 4-

hour Restri cted Entry Interval (REI), and the EP is not classified as a restricted-use pesticide. 

4. Benefits and Public Comments 

Biopesticides are pesticides derived from such natural materials as animals, plants, bacteria, and 

certain minerals. Microbial pesticides, a class of biopesticides, consist of a microorganism (e.g., 

bacterium, fungus, virus, or protozoan) as the active ingredient and may have the following 

benefits: 

• Usually are inherently less harmful than conventional pesticides. 

• Generally affect only the target pest and closely related organisms, in contrast to broadspectrum conventional pesticides that may affect many different organisms (e.g., birds, 

insects, and mammals). 

• Often effective in very small quantities and often decompose quickly, thereby resulting in 

lower exposures and largely avoiding the pollution problems caused by conventional 

pesticides. 

• Can greatly decrease the use of conventional pesticides while crop yields remain high, 

when used as a component of integrated pest management programs. 

• Can offer another tool for pest management in areas where pesticide resistance, niche 

markets, environmental concerns, and organic preference limit the use of conventional 

pesticides. 

Like other microbial pesticides, Spodoptera exigua multinucleopolyhedrovirus strain BV-0004 

aligns with the potential benefits above as it exhibits little to no toxicity or irritation, is not 

pathogenic or infective to nontarget organisms, is specific to certain lepidopteran species, and 

could fill particular needs in unique markets. 

In the Federal Register of Apri l 8, 2014 (79 FR 21919), the EPA announced receipt of the 

application to register a pesticide product containing a new active ingredient for use in 

agriculture. The EPA opened a 30-day public comment period pursuant to the provisions of 

FIFRA section 3(c)(4). Following this publication, the Agency received one public comment, 

which did not address this microbial pesticide. 

Because Andermatt's pesticide product application involves a new active ingredient, as well as 

this active ingredient's first food uses, the EPA opened a 15-day public comment period. The 

EPA took this action in accordance with a policy, first implemented in October 2009, designed to 

provide a more meaningful opportunity for the public to participate in major registration actions. 

No additional public comments were submitted. 

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5. Regulatory Decision 

The Spodoptera exigua multinucleopolyhedrovirus strain BY -0004 database is comprised of 

studies and information that meet the data requirements for and support the labeled uses of 

Spodoptera exigua multinucleopolyhedrovirus strain BY -0004. In considering the assessed risk 

to human health and the environment, the EPA concludes that Spodoptera exigua 

multinucleopolyhedrovirus strain BY-0004 meets the regulatory standard under the Federal 

Insecticide, Fungicide, and Rodenticide Act (FIFRA). Therefore, the EPA is granting the 

unconditional registration of the Spodoptera exigua multinucleopolyhedrovirus strain BY-0004 

pesticide product under FIFRA section 3(c)(5). 

One pesticide end-use product will be registered, Spexit, containing the sole active ingredient, 

Spodoptera exigua multinucleopolyhedrovirus strain BY-0004 for control of the Beet armyworm 

on agricultural crops (open fields and greenhouses) and in residential settings. Applicators and 

other users can apply Spexit at a rate of 1.0-2.5 fl. oz./acre (depending on the crop or plant). 

The risk assessments supporting this decision can be found in the associated regulatory dockets 

(search for "EPA-HQ-OPP-2014-0152" at www.regulations.gov). 

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