BIOPESTICIDES REGISTRATION ACTION DOCUMENT

Bacillus thuringiensis subspecies galleriae strain SDS-502 

Pesticide Chemical (PC) Code: 006399

U.S. Environmental Protection Agency 

Office of Pesticide Programs 

Biopesticides and Pollution Prevention Division 

DRAFT – May 15, 2013 
Bacillus thuringiensis subspecies galleriae strain SDS-502 Page 2 of 42 

Biopesticides Registration Action Document 

TABLE OF CONTENTS

I. EXECUTIVE SUMMARY ......................................................................................................................... 4

II. ACTIVE INGREDIENT OVERVIEW ..................................................................................................... 6

III. REGULATORY BACKGROUND ............................................................................................................ 7

 A. Applications for Pesticide Product Registration ........................................................................... 7

 B. Food Tolerance Exemption ............................................................................................................. 7

IV. RISK ASSESSMENT .................................................................................................................................. 8

 A. Product Analysis Assessment (40 C.F.R. § 158.2120) ................................................................... 8

 B. Human Health Assessment (40 C.F.R. § 158.2140) ....................................................................... 8

 C. Environmental Assessment (40 C.F.R. § 158.2150) ..................................................................... 15

V. ENVIRONMENTAL JUSTICE ............................................................................................................... 18

VI. RISK MANAGEMENT DECISION ....................................................................................................... 19

VII. ACTIONS REQUIRED OF THE REGISTRANT ................................................................................. 19

VIII. GLOSSARY OF ACRONYMS AND ABBREVIATIONS .................................................................... 22

IX. BIBLIOGRAPHY ..................................................................................................................................... 23

 A. Studies Submitted to Support the Bacillus thuringiensis subspecies galleriae strain 

 SDS-502 Pesticide Product Registrations .................................................................................... 23

 B. Environmental Protection Agency Risk Assessment Memoranda ............................................ 29

 C. Other References ............................................................................................................................ 29

APPENDIX A. MICROBIAL PESTICIDES DATA REQUIREMENTS ........................................................ 32

APPENDIX B. PESTICIDE PRODUCTS .......................................................................................................... 42
Bacillus thuringiensis subspecies galleriae strain SDS-502 Page 3 of 42 

Biopesticides Registration Action Document 

BIOPESTICIDES REGISTRATION ACTION DOCUMENT TEAM 

Office of Pesticide Programs (OPP) 

Biopesticides and Pollution Prevention Division 

Microbial Pesticides Branch 

Science Reviews

Joel V. Gagliardi, Ph.D. Product Analysis, Human Health 

John L. Kough, Ph.D. Product Analysis, Human Health 

Gail Tomimatsu, Ph.D. Environmental Effects 

Shannon Borges Environmental Effects 

Regulations 

Kimberly Nesci Chief, Microbial Pesticides Branch 

Jeannine Kausch Regulatory Action Leader 
Bacillus thuringiensis subspecies galleriae strain SDS-502 Page 4 of 42 

Biopesticides Registration Action Document 

I. EXECUTIVE SUMMARY 

Background

In July and August 2011, Phyllom, LLC, submitted applications for a manufacturing-use pesticide 

product, Phyllom SDS-502 MP (EPA File Symbol: 88347-R), and an end-use pesticide product, 

Phyllom grubGONE! G (EPA File Symbol: 88347-E), to the U.S. Environmental Protection Agency 

(EPA) under section 3 of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). In 

November 2012, Phyllom, LLC, submitted another application for an end-use pesticide product, 

Phyllom beetleGONE!TM biological insecticide (EPA File Symbol: 88347-G). These pesticide products 

contain a new active ingredient, Bacillus thuringiensis subspecies galleriae strain SDS-502. 

Bacillus thuringiensis is a naturally occurring organism commonly found in soil. It forms parasporal 

crystalline bodies, which are toxic for certain invertebrates, especially species of insect larvae belonging 

to the insect orders Coleoptera (beetles), Diptera (flies), and Lepidoptera (butterflies and moths) (Bravo 

2007). The toxicity of the crystalline bodies is strain-specific; that is, not all Bacillus thuringiensis 

strains are toxic to all insects. 

Bacillus thuringiensis was first discovered in Japan (1901) by Ishiwata during his study of a bacterial 

disease of silkworms. Later, in 1915, a German scientist named Berliner found a similar bacillus killing 

the larvae of flour moths; he published a description of the bacterium and its properties, naming it 

Bacillus thuringiensis.

1

 In the 1930’s, French researchers recognized its potential for use in agriculture 

and developed a product known as Sporeine (Federici 2005). In 1961, Bacillus thuringiensis was 

registered as a pesticide in the United States (U.S. EPA 1998). Today, there are more than 100 registered 

pesticide products containing Bacillus thuringiensis as an active ingredient. 

Bacillus thuringiensis subspecies galleriae strain SDS-502 was isolated from a soil sample in Japan, and 

data demonstrate that it is highly active against scarab beetles, such as the cupreous chafer (Anomala 

cuprea) (Asano et al. 2003). Bacillus thuringiensis pesticide products used against coleopteran insects 

are not as common as those used against lepidopteran insects (e.g., Bacillus thuringiensis subspecies 

tenebrionis and Bacillus thuringiensis subspecies israelensis). Given Bacillus thuringiensis subspecies

galleriae strain SDS-502’s ability to control certain coleopteran insects, Phyllom, LLC, proposed to 

register a manufacturing-use pesticide product and two end-use pesticide products that are intended to be 

applied to turf, ornamentals, and food crops, as well as in poultry premises, to control white grubs of 

beetles and adult beetles. 

The EPA’s scientists reviewed product analysis, toxicology, and nontarget organism data and 

information (40 C.F.R. §§ 158.2120, 158.2140, and 158.2150, respectively) submitted to support the 

registration of the three proposed Bacillus thuringiensis subspecies galleriae strain SDS-502 pesticide 

products. Overall, such data and information are adequate for risk assessment purposes, fulfill the 

current microbial pesticide data requirements, and support registration of the proposed products under 

FIFRA section 3(c)(5). 

 

1 The species name “thuringiensis” is derived from Thuringia, the region in Germany in which the disease occurred (Federici 

2005). 
Bacillus thuringiensis subspecies galleriae strain SDS-502 Page 5 of 42 

Biopesticides Registration Action Document 

Product Analysis

The applicant fulfilled most of the product analysis data requirements for Bacillus thuringiensis 

subspecies galleriae strain SDS-502, including product chemistry and composition, analysis of samples, 

and physical and chemical characteristics, by acceptable guideline studies. As terms of registration, the 

EPA will require the applicant to submit storage stability, corrosion characteristics, and pH studies. 

Toxicology

The applicant submitted adequate mammalian toxicology data and information to support the Bacillus 

thuringiensis subspecies galleriae strain SDS-502 pesticide products. Acute oral and injection 

toxicity/pathogenicity studies and an acute inhalation toxicity study showed that, at a single high dose, 

Bacillus thuringiensis subspecies galleriae strain SDS-502 is not toxic, infective, and/or pathogenic via 

these routes of exposure. Moreover, the applicant reported that no hypersensitivity incidents occurred 

during research, development, or testing of Bacillus thuringiensis subspecies galleriae strain SDS-502. 

In light of the results of the acute toxicity/pathogenicity data and the absence of hypersensitivity 

incidents, the EPA is not requiring testing at higher tiers (i.e., Tiers II and III). 

Tolerance Exemption

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

including infants and children, from aggregate exposure to residues of Bacillus thuringiensis subspecies

galleriae strain SDS-502. The EPA expects no dietary risks are expected from use of Bacillus 

thuringiensis subspecies galleriae strain SDS-502 as an active ingredient in pesticide products. 

Although exposure to Bacillus thuringiensis subspecies galleriae strain SDS-502 through consumed 

food and drinking water may be possible, the EPA anticipates these types of exposures not to be of 

concern because of supporting toxicological data. Bacillus thuringiensis subspecies galleriae strain 

SDS-502 currently meets the criteria of 40 C.F.R. § 180.1011. 

Occupational Exposure

Despite the low toxicological profile of Bacillus thuringiensis subspecies galleriae strain SDS-502, the 

EPA is requiring baseline personal protective equipment (PPE) for handlers who, due to their 

occupation, may be exposed to the active ingredient for prolonged periods and/or numerous times. 

Handlers working with Bacillus thuringiensis subspecies galleriae strain SDS-502 in agricultural or 

commercial settings are directed to wear a long-sleeved shirt, long pants, socks, shoes, waterproof 

gloves, protective eyewear and/or a dust/mist filtering respirator meeting National Institute for 

Occupational Safety and Health (NIOSH) standards of at least N-95, R-95, or P-95. For future products, 

the EPA may require additional/different PPE (e.g., chemical-resistant gloves), other than the standard 

described above, on a product-specific basis. 

Nontarget Organisms

The EPA found that guideline studies and scientific rationale submitted by the applicant are sufficient to 

fulfill the nontarget organism data requirements and for risk assessment purposes. Further testing of 

nontarget organisms at higher tier levels (i.e., Tiers II, III, and IV) is not required. The EPA performed 

an environmental risk assessment, based on information provided by the applicant, and determined that 

no effects are anticipated for most nontarget species exposed to Bacillus thuringiensis subspecies

galleriae strain SDS-502 as a result of the proposed labeled applications. 

 
Bacillus thuringiensis subspecies galleriae strain SDS-502 Page 6 of 42 

Biopesticides Registration Action Document 

Public Participation

On October 1, 2009, the EPA announced a policy to provide a more meaningful opportunity for the 

public to participate in major registration decisions before they occur. According to this policy, the EPA 

provides a public comment period prior to making a registration decision for the following types of 

applications: new active ingredients; first food uses; first outdoor uses; first residential uses; or any other 

registration actions for which the EPA believes there may be significant public interest. 

 

Consistent with the policy of making registration actions more transparent, the proposed pesticide 

products containing Bacillus thuringiensis subspecies galleriae strain SDS-502, a new active ingredient, 

will be subject to a comment period. In addition to containing a new active ingredient, the registration of 

these pesticide products would result in the first food, outdoor, and residential uses for Bacillus 

thuringiensis subspecies galleriae strain SDS-502. The docket identification number, which is 

associated with these registration actions and can be accessed through either http://www.regulations.gov

or http://www.epa.gov/pesticides/regulating/registration-status.html, is EPA-HQ-OPP-2011-0862. The 

following documents are available for comment in EPA-HQ-OPP-2011-0862: (1) a draft Bacillus 

thuringiensis subspecies galleriae strain SDS-502 Biopesticides Registration Action Document 

(BRAD); (2) an environmental risk assessment for Bacillus thuringiensis subspecies galleriae strain 

SDS-502; (3) a draft label for the manufacturing-use pesticide product, Phyllom SDS-502 MP (EPA File 

Symbol: 88347-R); (4) a draft label for the end-use pesticide product, Phyllom grubGONE! G (EPA File 

Symbol: 88347-E); and (5) a draft label for the end-use pesticide product, Phyllom beetleGONE!TM

biological insecticide (EPA File Symbol: 88347-G). While a final decision on registration is contingent 

upon review and consideration of public comments, the EPA presently believes that, based upon the risk 

assessment and information submitted in support of Phyllom SDS-502 MP, Phyllom grubGONE! G, and 

Phyllom beetleGONE!TM biological insecticide, it is appropriate to issue these registrations. The basis for 

this preliminary decision can be found in the risk assessment for Bacillus thuringiensis subspecies

galleriae strain SDS-502, which is characterized throughout this BRAD. 

II. ACTIVE INGREDIENT OVERVIEW 

Biological Name: Bacillus thuringiensis subspecies galleriae strain SDS-502

Culture Deposit: Japan International Patent Organism Depository, National Institute 

of Technology and Evaluation in Tsukuba-shi, Japan under 

Accession Number FERM BP-7667 

 OPP Chemical Code: 006399 

 Type of Pesticide: Microbial Pesticide – Insecticide 

 See Appendix B for specific information (e.g., 

use sites, application rates, methods of application, 

formulation types, and target pests) regarding 

the proposed pesticide products containing this 

active ingredient. 
Bacillus thuringiensis subspecies galleriae strain SDS-502 Page 7 of 42 

Biopesticides Registration Action Document 

III. REGULATORY BACKGROUND

A. Applications for Pesticide Product Registration 

In July and August 2011, Phyllom, LLC (address: 922 San Leandro Avenue; Suite F; Mountain View, 

California 94043), submitted applications to register a manufacturing-use pesticide product, Phyllom 

SDS-502 MP (EPA File Symbol: 88347-R), and an end-use pesticide product, Phyllom grubGONE! G 

(EPA File Symbol: 88347-E), under FIFRA section 3. On February 29, 2012 (77 FR 12295), the EPA 

announced receipt of these applications to register pesticide products containing a new active ingredient 

and opened a 30-day public comment period pursuant to the provisions of FIFRA section 3(c)(4). No 

comments were received following this publication. 

In November 2012, Phyllom, LLC, submitted an application to register an end-use pesticide product, 

Phyllom beetleGONE!TM (EPA File Symbol 88347-G) under FIFRA section 3. On April 19, 2013, the 

EPA announced receipt of this application to register a pesticide product containing a new active 

ingredient (78 FR 23558) and opened a 30-day public comment period pursuant to the provisions of 

FIFRA section 3(c)(4). No comments were received following this publication. 

B. Food Tolerance Exemption 

An exemption from the requirement of a tolerance is established for viable spores of the microorganism 

Bacillus thuringiensis Berliner in or on honey and honeycomb and all other raw agricultural 

commodities when it is applied either to growing crops, or when it is applied after harvest in accordance 

with good agricultural practices, provided the specifications set forth in the exemption are met (40 

C.F.R. § 180.1011). The specifications are listed below: 

(1) The microorganism shall be an authentic strain of Bacillus thuringiensis Berliner conforming to the 

morphological and biochemical characteristics of Bacillus thuringiensis as described in Bergey's 

Manual of Determinative Bacteriology, Eighth Edition. 

(2) Spore preparations of Bacillus thuringiensis Berliner shall be produced by pure culture fermentation 

procedures with adequate control measures during production to detect any changes from the 

characteristics of the parent strain or contamination by other microorganisms. 

(3) Each lot of spore preparation, prior to the addition of other materials, shall be tested by subcutaneous 

injection of at least 1 million spores into each of five laboratory test mice weighing 17 grams to 23 

grams. Such test shall show no evidence of infection or injury in the test animals when observed for 

7 days following injection. 

(4) Spore preparations shall be free of the Bacillus thuringiensis β-exotoxin when tested with the fly 

larvae toxicity test (“Microbial Control of Insects and Mites,” R.P.M. Bond et al., p. 280 ff., 1971). 

This specification can be satisfied either by determining that each master seed lot brought into 

production is a Bacillus thuringiensis strain that does not produce β-exotoxin under standard 

manufacturing conditions or by periodically determining that β-exotoxin synthesized during spore 

production is eliminated by the subsequent spore-harvesting procedure. 
Bacillus thuringiensis subspecies galleriae strain SDS-502 Page 8 of 42 

Biopesticides Registration Action Document 

The EPA determined that Bacillus thuringiensis subspecies galleriae strain SDS-502 currently meets the 

criteria of 40 C.F.R. § 180.1011. To ensure that producers of Phyllom SDS-502 MP (the source of active 

ingredient for the Bacillus thuringiensis subspecies galleriae strain SDS-502 end-use pesticide products) 

continue to manufacture product in accordance with the tolerance exemption criteria, the EPA will also 

be integrating these quality control measures into the text of the Phyllom SDS-502 MP registration 

notice as terms. 

IV. RISK ASSESSMENT 

In the Federal Registers of October 26, 2007 (72 FR 60988) and August 30, 2012 (77 FR 52610), the 

EPA issued Final Rules on the data requirements to support registration of microbial pesticides and 

updated the definition for microbial pesticides. The data and information evaluated for this BRAD were 

considered in light of these requirements. 

The classifications that are found for each data submission are assigned by the EPA’s science reviewers 

and are an indication of the usefulness of the information contained in the documents for risk 

assessment. A rating of “acceptable” indicates the study is scientifically sound and is useful for risk 

assessment. A “supplemental” rating indicates the data provide some information that can be useful for 

risk assessment. The studies may have certain aspects determined not to be scientifically acceptable 

(“supplemental: upgradeable”). If a study is rated as “supplemental: upgradeable,” the EPA always 

provides an indication of what is lacking or what can be provided to change the rating to “acceptable.” If 

there is simply a “supplemental” rating, the reviewer will often state that the study is not required by 40 

C.F.R. Part 158. Both “acceptable” and “supplemental” studies may be used in the risk assessment 

process as appropriate. An “unacceptable” rating indicates that new data must be submitted. 

For the acute toxicity data requirements, Toxicity Categories are assigned based on the 

hazard(s) identified from studies and/or other information submitted to the EPA in support of a pesticide 

registration. The active ingredient or particular product is classified into Toxicity Category I, II, III, or 

IV, where Toxicity Category I indicates the highest toxicity and Toxicity Category IV indicates the 

lowest toxicity (see section II of U.S. EPA (2012b)). 

A. Product Analysis Assessment (40 C.F.R. § 158.2120) 

With the exception of a one-year storage stability and corrosion characteristics study and a pH study, the 

applicant fulfilled all product analysis data requirements for Bacillus thuringiensis subspecies galleriae

strain SDS-502. Refer to Tables 1, 2, 3, and 4 in Appendix A for a summary of the data requirements, 

including both generic and product-specific information. 

B. Human Health Assessment (40 C.F.R. § 158.2140)

1. Toxicity 

The applicant fulfilled all toxicology data requirements for Bacillus thuringiensis subspecies galleriae

strain SDS-502. Acceptable Tier I mammalian toxicology data and information support registration of 

the Bacillus thuringiensis subspecies galleriae strain SDS-502 pesticide products. The EPA is not 

requiring Tier II and Tier III studies for Bacillus thuringiensis subspecies galleriae strain SDS-502 

based on the lack of acute toxicity/pathogenicity in the Tier I studies attributed to the bacterium. 
Bacillus thuringiensis subspecies galleriae strain SDS-502 Page 9 of 42 

Biopesticides Registration Action Document 

For a summary of the generic toxicology data requirements described in sections IV(B)(1)(a) and 

IV(B)(1)(b), as well as additional product-specific data submitted to support the individual registrations, 

refer to Tables 5 and 6 in Appendix A. 

a. Acute Toxicity/Pathogenicity – Tier I

Acute Oral Toxicity/Pathogenicity – Rat (Harmonized Guideline 885.3050; Master Record 

Identification Numbers (MRID Nos.) 485532-08, 485532-11, and 489401-08): In an acute oral toxicity 

and pathogenicity study, groups of fasted, 9-week-old rats (2 or 3 per sex) were given a single oral dose 

of Bacillus thuringiensis subspecies galleriae strain SDS-502 in sterile phosphate buffered saline at a 

dose of 2.4 x 108

 cfu per animal. The animals were observed for a period of up to 21 days, with interim 

scheduled sacrifices on days 3, 7, and 14. Three males and three females were treated with heatinactivated Bacillus thuringiensis subspecies galleriae strain SDS-502 as inactivated controls, two males 

and two females were untreated shelf controls, and two males and two females were untreated, non-shelf 

controls. Based on the results of this study, Bacillus thuringiensis subspecies galleriae strain SDS-502 

does not appear to be toxic, infective, or pathogenic in rats, when dosed at 2.4 x 108

 cfu per animal. 

There were no treatment-related deaths, clinical signs, necropsy findings, or changes in body weight or 

body weight gain. Only samples from day 0 and day 21 were analyzed; high levels for test organism 

were present in feces on day 0, while no test organism was recovered from the cecum contents or any 

organ or blood from treated animals sacrificed on day 21. The EPA rated this study acceptable.

Acute Pulmonary Toxicity/Pathogenicity – Rat (Harmonized Guideline 885.3150; MRID Nos. 485532-

09, 485532-11, and 489401-08): In an acute pulmonary toxicity and pathogenicity study, groups of 9-

week-old rats (3 or 5 per sex per group) were exposed by the intratracheal route to Bacillus thuringiensis 

subspecies galleriae strain SDS-502 in sterile phosphate buffered saline. Six males and five females 

were treated with heat-inactivated Bacillus thuringiensis subspecies galleriae strain SDS-502, and two 

males and two females served as untreated controls. The inactive- and active-treated animals were 

initially mis-dosed at approximately 0.2 x 108 cfu per animal, and three male and three female activetreated animals were killed (on schedule) before the mis-dosing was recognized. The following day, 

three male inactive controls were treated with a dose approximately equivalent to 2 x 108

 cfu per animal 

with immediate mortality. The remaining animals scheduled to be treated, as well as three male and 

three female replacement animals, were treated at a dose of 1.2 x 108

 cfu per animal in a 0.5 milliliter 

dosing volume, and the surviving inactive-treated animals were treated at an approximately equivalent 

dose. The animals were observed for 21 days after the second dose. In addition to the three males treated 

with the initial formulation of the inactive control, 2 of 3 males and 3 of 5 females treated with the 

further diluted and homogenized inactive suspension were found dead on days 0–1, and an additional 

female in this group was sacrificed in extremis on day 0. One female treated with the active suspension 

was found dead on day 1 after exhibiting lethargy, labored breathing, gasping, and inappetence. Red, 

mottled discoloration of the lungs and red staining of the face were found on this animal at necropsy. 

Additional treatment-related clinical signs among the surviving active-treated animals included 

inappetence, ocular and/or nasal discharge, lethargy, noisy breathing, and staining of the fur and skin. 

The study author attributed these signs to the physical properties of the dosing formulations. Body 

weight losses were noted for the active-treated animals of both sexes killed on day 3, and the activetreated males had decreased body weight gain during days 0–7. Abnormal gross necropsy findings 

among animals killed on schedule were limited to tan, mottled discoloration of the lungs in the three 

males and three females that were killed on day 7. Average cfu counts decreased over time in all of the 

evaluated tissues or samples, but the test organisms did remain present through day 21 with the highest 
Bacillus thuringiensis subspecies galleriae strain SDS-502 Page 10 of 42 

Biopesticides Registration Action Document 

counts seen in lung tissue (126 cfu per gram). No conclusions can be made regarding infectivity, 

pathogenicity, or toxicity based on these study results. Attributing lethal effects to dosing was not 

followed up with alternate dosing methods. The EPA rated this study unacceptable and concluded that a 

replacement pulmonary toxicity/pathogenicity study or an inhalation toxicity study was required to 

address pulmonary effects. (See review summary for MRID No. 489731-01, directly below.) 

 

Acute Inhalation Toxicity – Rat (Harmonized Guideline 870.1300; MRID No. 489731-01): All animals 

survived and gained weight with exception of 1 male that lost 7 grams after day 7. Symptoms noted 

between 4.5 and 6 hours after exposure included red nasal discharge, red crust around eyes, decreased 

activity and piloerection noted as slight in 2–5 of the males and very slight red crust around the 

nose of 1 female at 4.5 hours. No other symptoms were reported through day 14 of the study. No 

observable abnormalities were noted at necropsy. The inhalation median lethal concentration (LC50) was 

greater than 4.30 mg/L, and the EPA rated this study acceptable. 

Acute Injection Toxicity/Pathogenicity (Intraperitoneal) – Rat (Harmonized Guideline 885.3200; MRID 

Nos. 485532-10, 485532-11, and 489401-08): In an acute intraperitoneal injection toxicity and 

pathogenicity study, 15 male and 15 female 11-week-old rats were injected with Bacillus thuringiensis 

subspecies galleriae strain SDS-502 in sterile phosphate buffered saline at a dose of 2.02 x 107 cfu per 

animal and observed for up to 21 days with interim sacrifices of 3 animals per sex done on days 0, 3, 7, 

and 14. Two additional groups of two males and two females were either left untreated or treated with a 

suspension of the heat-inactivated test material. Bacillus thuringiensis subspecies galleriae strain SDS502 was not pathogenic or overtly toxic when dosed intraperitoneally; however, the test organism 

persisted in the animals through day 21. There were no treatment-related deaths, clinical signs, or 

necropsy findings, and body weight gain was not significantly affected. The test organism was recovered 

from cecum contents, organ and blood samples from active-treated animals sacrificed on day 21 and was 

most prevalent in lymph node samples (33.3 cfu per gram). The EPA rated this study acceptable. 

Hypersensitivity Incidents (Harmonized Guideline 885.3400; MRID No. 485532-12): The applicant 

reported that no hypersensitivity incidents, including immediate-type or delayed-type reactions of 

humans and domestic animals, occurred during research, development, or testing of Bacillus 

thuringiensis subspecies galleriae strain SDS-502. Any future hypersensitivity incidents must be 

reported to the EPA (refer to test note #3 of 40 C.F.R. § 158.2140(d)). 

Cell Culture (Harmonized Guideline 885.3500; MRID No. 485532-13): This study is not required 

because Bacillus thuringiensis subspecies galleriae strain SDS-502 is not a virus (refer to test note #4 of 

40 C.F.R. § 158.2140(d)). 

b. Acute Toxicology and Subchronic Toxicity/Pathogenicity – Tier II; 

 Reproductive Fertility Effects, Carcinogenicity, Immunotoxicity, and 

 Infectivity/Pathogenicity Analysis – Tier III 

The EPA is not requiring Tier II and Tier III studies for Bacillus thuringiensis subspecies galleriae

strain SDS-502 based on the lack of acute toxicity/pathogenicity in the Tier I studies attributed to the 

bacterium. Any uncertainties about the toxicity, pathogenicity, or infectivity of Bacillus thuringiensis 

subspecies galleriae strain SDS-502 raised in the acute pulmonary toxicity/pathogenicity study (MRID 

No. 485532-09) were addressed by a subsequent acute inhalation toxicity study (MRID No. 489731-01) 

and information to support lack of infectivity of Bacillus thuringiensis subspecies galleriae strain SDS502 (MRID No. 489401-08). 
Bacillus thuringiensis subspecies galleriae strain SDS-502 Page 11 of 42 

Biopesticides Registration Action Document 

c. Endocrine Disruptors 

As required by the Administrator under FFDCA section 408(p), the EPA has developed the Endocrine 

Disruptor Screening Program (EDSP) and has begun to implement the screening program that is to be 

used to test all pesticides in order to determine whether certain substances (including pesticide active 

and other ingredients) may have an effect in humans or wildlife similar to an effect produced by a 

“naturally occurring estrogen, or other such endocrine effects as the Administrator may designate.” 

FFDCA section 408(p)(4) authorizes the Administrator, by order, to exempt from the requirements of 

the Estrogenic Substances Screening Program a biologic substance or other substance if a determination 

is made that the substance is not anticipated to produce any effect in humans similar to an effect 

produced by a naturally occurring estrogenic substance. 

Between October 2009 and February 2010, the EPA issued test orders/data call-ins for the first group of 

67 chemicals, which contains 58 pesticide active ingredients and 9 inert ingredients. Bacillus 

thuringiensis subspecies galleriae strain SDS-502 is not among the group of 58 pesticide active 

ingredients on the initial list to be screened under the EDSP. 

The EPA believes that Bacillus thuringiensis subspecies galleriae strain SDS-502, the active ingredient 

described in this document, likely is a substance that would not produce any effect in humans similar to 

an effect produced by a naturally occurring estrogenic substance. As such, pursuant to Section 

408(p)(4), the EPA will determine in the future whether it can exempt Bacillus thuringiensis subspecies

galleriae strain SDS-502 from the requirements of the Section 408(p) EDSP. In the event the EPA does 

determine to exempt this substance from the EDSP, an order will be issued. 

For further information on the status of the EDSP, the policies and procedures, the list of 67 chemicals, 

the test guidelines and the Tier 1 screening battery, please visit our website at http://www.epa.gov/endo/. 

2. Federal Food, Drug, and Cosmetic Act (FFDCA) Considerations 

Section 408(c)(2)(A)(i) of FFDCA allows the EPA to establish an exemption from the requirement for a 

tolerance (the legal limit for a pesticide chemical residue in or on a food) only if the EPA determines 

that the exemption is “safe.” Section 408(c)(2)(A)(ii) of FFDCA defines “safe” to mean that “there is a 

reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, 

including all anticipated dietary exposures and all other exposures for which there is reliable 

information.” This includes exposure through drinking water and in residential settings but does not 

include occupational exposure. Pursuant to FFDCA section 408(b)(2)(B), in establishing or maintaining 

in effect an exemption from the requirement of a tolerance, the EPA must take into account the factors 

set forth in FFDCA section 408(b)(2)(C), which require the EPA to give special consideration to 

exposure of infants and children to the pesticide chemical residue in establishing a tolerance exemption, 

and to “ensure that there is a reasonable certainty that no harm will result to infants and children from 

aggregate exposure to the pesticide chemical residue....” Additionally, FFDCA section 408(b)(2)(D) 

requires that the EPA consider “available information concerning the cumulative effects of [a particular 

pesticide's] . . . residues and other substances that have a common mechanism of toxicity.” 
Bacillus thuringiensis subspecies galleriae strain SDS-502 Page 12 of 42 

Biopesticides Registration Action Document 

The EPA performs a number of analyses to determine the risks from aggregate exposure to pesticide 

residues. First, the EPA determines the toxicity of pesticides. Second, the EPA examines exposure to the 

pesticide through food, drinking water, and through other exposures that occur as a result of pesticide 

use in residential settings. 

Consistent with FFDCA section 408(b)(2)(D), the EPA reviewed the available scientific data and other 

relevant information on Bacillus thuringiensis subspecies galleriae strain SDS-502, and considered its 

validity, completeness, and reliability, as well as the relationship of this information to human risk. The 

EPA also considered available information concerning the variability of the sensitivities of major 

identifiable subgroups of consumers, including infants and children. 

Based on the acute toxicity/pathogenicity data and information discussed previously and presented in 

Tables 5 and 6 in Appendix A, the data required for a FFDCA risk assessment for Bacillus thuringiensis 

subspecies galleriae strain SDS-502 have been fulfilled. 

a. Aggregate Exposure 

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

concerning exposures from the pesticide residue in food and all other non-occupational exposures, 

including drinking water from ground water or surface water and exposure through pesticide use in 

gardens, lawns, or buildings (residential and other indoor uses). 

Food Exposure and Risk Characterization: Exposure to residues of Bacillus thuringiensis subspecies

galleriae strain SDS-502 in food may occur through the consumption of food commodities that have 

been treated with microbial pesticides containing this bacterium. The EPA expects the exposure to food 

residues of Bacillus thuringiensis subspecies galleriae strain SDS-502 to be negligible when compared 

to the ordinary, everyday levels to which individuals are already exposed in the natural environment—

Bacillus thuringiensis is commonly found in soil and on plants (Damgaard et al. 1998; Gao et al. 2008; 

Mizuki et al. 1999). Although residues from the use of pesticides containing Bacillus thuringiensis 

subspecies galleriae strain SDS-502 may be present on certain food commodities, processing procedures 

(e.g., peeling and washing) may reduce such residues (U.S. EPA 1996). Regardless of the scenario, 

should Bacillus thuringiensis subspecies galleriae strain SDS-502 be present on food, supporting 

toxicological data indicate that no toxicity, pathogenicity, and/or infectivity is likely to occur with any 

food exposure resulting from the use of Bacillus thuringiensis subspecies galleriae strain SDS-502 as a 

pesticide when manufactured to meet the specifications of 40 C.F.R. § 180.1011 and applied in 

accordance with label directions and good agricultural practices (see section IV(B)(1)(a) and Tables 5 

and 6 in Appendix A). 

Drinking Water Exposure and Risk Characterization: Exposure to residues of Bacillus thuringiensis 

subspecies galleriae strain SDS-502, a naturally occurring bacterium (Damgaard et al. 1998; Gao et al. 

2008; Mizuki et al. 1999), in consumed drinking water is possible. End-use pesticide products 

containing Bacillus thuringiensis subspecies galleriae strain SDS-502 can be applied with ground and 

aerial equipment to many different plants. Runoff from treated areas and spray drift are definite 

possibilities. If Bacillus thuringiensis subspecies galleriae strain SDS-502 were to be transferred to 

ground or surface waters as a result of runoff or spray drift, this bacterium could survive the conditions 

water is subjected to in wastewater treatment systems and drinking facilities (e.g., pH adjustments and 

chlorination). According to the World Health Organization, Bacillus species, such as thuringiensis, are 

often detected in drinking water even after going through acceptable water treatment processes, largely 
Bacillus thuringiensis subspecies galleriae strain SDS-502 Page 13 of 42 

Biopesticides Registration Action Document 

because the spores are resistant to these disinfection processes (World Health Organization 2011). 

Should Bacillus thuringiensis subspecies galleriae strain SDS-502 be present in drinking water, 

supporting toxicological data indicate that no toxicity, pathogenicity, and/or infectivity is likely to occur 

with any drinking water exposure resulting from the use of Bacillus thuringiensis subspecies galleriae

strain SDS-502 as a pesticide when manufactured to meet the specifications of 40 C.F.R. § 180.1011 and 

applied in accordance with label directions and good agricultural practices (see section IV(B)(1)(a) and 

Tables 5 and 6 in Appendix A). 

Non-occupational, Residential Risk Characterization: Given Bacillus thuringiensis’ natural presence in 

the environment (Damgaard et al. 1998; Gao et al. 2008; Mizuki et al. 1999), dermal and inhalation 

non-occupational exposures to Bacillus thuringiensis subspecies galleriae strain SDS-502 almost 

certainly are already occurring. Additional exposure to Bacillus thuringiensis subspecies galleriae strain 

SDS-502 may occur because the end-use pesticide products are labeled for application to sites like 

athletic fields, residential lawns, and playgrounds. Even if additional non-occupational exposures were 

to occur, no adverse effects attributed to Bacillus thuringiensis subspecies galleriae strain SDS-502 are 

anticipated, particularly in light of testing results that indicated this bacterium is not toxic, pathogenic, or 

infective and is essentially non-irritating to skin at high doses (see section IV(B)(1)(a) and Tables 5 and 

6 in Appendix A). 

b. Cumulative Effects from Substances with a Common Mechanism of Toxicity 

Section 408(b)(2)(D)(v) of FFDCA requires that, when considering whether to establish, modify, or 

revoke a tolerance, the EPA consider “available information concerning the cumulative effects of [a 

particular pesticide’s] . . . residues and other substances that have a common mechanism of toxicity.” 

The EPA has not found Bacillus thuringiensis subspecies galleriae strain SDS-502 to share a common 

mechanism of toxicity with any other substances, and Bacillus thuringiensis subspecies galleriae strain 

SDS-502 does not appear to produce a toxic metabolite produced by other substances. For the purposes 

of this tolerance action, therefore, the EPA has assumed that Bacillus thuringiensis subspecies galleriae

strain SDS-502 does not have a common mechanism of toxicity with other substances. Following from 

this, therefore, the EPA concludes that there are no cumulative effects associated with Bacillus 

thuringiensis subspecies galleriae strain SDS-502 that need to be considered. For information regarding 

the EPA’s efforts to determine chemicals that have a common mechanism of toxicity and to evaluate the 

cumulative effects of such chemicals, see the EPA’s website at 

http://www.epa.gov/pesticides/cumulative. 

 c. Determination of Safety for the United States Population, Infants and Children 

FFDCA section 408(b)(2)(C) provides that, in considering the establishment of a tolerance or tolerance 

exemption for a pesticide chemical residue, the EPA shall assess the available information about 

consumption patterns among infants and children, special susceptibility of infants and children to 

pesticide chemical residues, and the cumulative effects on infants and children of the residues and other 

substances with a common mechanism of toxicity. In addition, FFDCA section 408(b)(2)(C) provides 

that the EPA shall apply an additional tenfold (10X) margin of safety for infants and children in the case 

of threshold effects to account for prenatal and postnatal toxicity and the completeness of the database 

on toxicity and exposure, unless the EPA determines that a different margin of safety will be safe for 

infants and children. This additional margin of safety is commonly referred to as the Food Quality 

Protection Act Safety Factor. In applying this provision, the EPA either retains the default value of 10X, 
Bacillus thuringiensis subspecies galleriae strain SDS-502 Page 14 of 42 

Biopesticides Registration Action Document 

or uses a different additional or no safety factor when reliable data are available to support a different 

additional or no safety factor. 

Based on the acute toxicity and pathogenicity data/information discussed in section IV(B)(1)(a) and 

Tables 5 and 6 in Appendix A, the EPA concludes that there are no threshold effects of concern to 

infants, children, or adults when Bacillus thuringiensis subspecies galleriae strain SDS-502 is 

manufactured according to the criteria set forth in 40 C.F.R. § 180.1011, is used as labeled, and good 

agricultural practices are followed. As a result, the EPA concludes that no additional margin of exposure 

(safety) is necessary. 

Moreover, based on the same data and analysis as presented directly above, the EPA is able to conclude 

that there is a reasonable certainty that no harm will result to the U.S. population, including infants and 

children, from aggregate exposure to the residues of Bacillus thuringiensis subspecies galleriae strain 

SDS-502 when it is manufactured according to the criteria set forth in 40 C.F.R. § 180.1011 and used as 

labeled as an insecticide. Such exposure includes all anticipated dietary exposures and all other 

exposures for which there is reliable information. The EPA has arrived at this conclusion because, 

considered collectively, the data and information available on Bacillus thuringiensis subspecies

galleriae strain SDS-502 do not demonstrate toxic, pathogenic, and/or infective potential to mammals, 

including infants and children. 

3. Occupational Exposure and Risk Characterization 

Handler exposure to Bacillus thuringiensis subspecies galleriae strain SDS-502 is not expected to pose 

any undue risk. Regardless, the EPA is requiring appropriate personal protective equipment and 

precautionary statements on pesticide product labels to mitigate any potential risks to pesticide handlers 

due to prolonged and/or numerous exposures. Handlers working with Bacillus thuringiensis subspecies

galleriae strain SDS-502 in agricultural or commercial settings are directed to wear a long-sleeved shirt, 

long pants, socks, shoes, waterproof gloves, protective eyewear, and/or a dust/mist filtering respirator 

meeting NIOSH standards of at least N-95, R-95, or P-95. For future products, the EPA may require 

additional/different PPE (e.g., chemical-resistant gloves), other than the standard described above, on a 

product-specific basis. 

4. Human Health Risk Characterization 

The EPA considered human exposure to Bacillus thuringiensis subspecies galleriae strain SDS-502 in 

light of the standard for registration in FIFRA and the relevant safety factors in FFDCA. A 

determination has been made that no unreasonable adverse effects to the U.S. population in general, and 

to infants and children in particular, will result from incidental exposures when Bacillus thuringiensis 

subspecies galleriae strain SDS-502 pesticide products are applied to turf, to ornamentals, to various 

crops, and in poultry premises in accordance with the EPA’s approved labeling. 
Bacillus thuringiensis subspecies galleriae strain SDS-502 Page 15 of 42 

Biopesticides Registration Action Document 

C. Environmental Assessment (40 C.F.R. § 158.2150) 

The EPA found that guideline studies and scientific rationale submitted by the applicant are sufficient to 

fulfill the nontarget organism data requirements and for risk assessment purposes. Further testing of 

nontarget organisms at higher tier levels (i.e., Tiers II, III, and IV) is not required. The EPA performed 

an environmental risk assessment, based on information provided by the applicant, and determined that 

no effects are anticipated for most nontarget species exposed to Bacillus thuringiensis subspecies

galleriae strain SDS-502 as a result of the proposed labeled applications. 

For a summary of the generic data requirements described in sections IV(C)(1), refer to Table 7 in 

Appendix A. 

1. Ecological Exposure and Risk Characterization 

The end-use pesticide product (EP), Phyllom beetleGONE!TM biological insecticide, is proposed for 

application to many types of grain, vegetable and small fruit crops, including fruit and nut trees, 

greenhouse/shadehouse and ornamental plants and trees, and poultry premises. Proposed application 

methods include ground and aerial sprays, as well as chemigation. The EP, Phyllom grubGONE! G, is 

proposed for use on turfgrass and ornamentals plants and trees, and is intended to be applied by ground 

application equipment. The turfgrass sites include golf course greens, residential lawns, commercial 

grounds and sod farms, and the ornamentals sites include landscapes, interiorscapes, nurseries, fields 

and greenhouses. Since the proposed applications are expected to result in contact of the active 

ingredient (a.i.) with foliar surfaces and soil, and spray drift is expected to occur, exposure to terrestrial 

and aquatic nontarget organisms is possible. 

Based on current information concerning the amount of active ingredient2

 in the EP, Phyllom 

beetleGONE!TM biological insecticide, the EPA estimates terrestrial maximum environmental 

concentrations (EC) of Bacillus thuringiensis subspecies galleriae strain SDS-502 as approximately 

6,078 g/A. An aquatic maximum EC was estimated at 10.0 mg a.i./L of water. 

 a. Birds (Harmonized Guidelines 885.4050 and 885.4100) and Wild Mammals (Harmonized 

 Guideline 885.4150) (MRID Nos. 485532-19, 489401-07, 485532-20, and 485532-21; Rose 

 2013b) 

Birds and mammals may be exposed to Bacillus thuringiensis subspecies galleriae strain SDS-502, 

primarily through ingestion or contact with treated surfaces. Information presented to the EPA indicates 

low risk to birds and wild mammals as a result of the proposed applications. An acute oral toxicity study 

with birds at the maximum hazard dose (MRID No. 485532-19) showed that the acute oral median lethal 

dose (LD50) is 3.0 x 1011 cfu/kg of body weight per day. A study with laboratory rats exposed orally 

(MRID No. 485532-08) showed that Bacillus thuringiensis subspecies galleriae strain SDS-502 is not 

toxic, infective, or pathogenic when administered at maximum hazard doses. Other acute toxicological 

data volumes (MRID Nos. 485532-11 and 489401-08) provide additional information to conclude that 

toxicity to mammals is not expected. 

 

2 Terrestrial maximum EC calculation: 17.5 lb/A * 454 g/lb * 1 acre * 76.5% a.i. in EP; aquatic maximum EC calculation: 

17.5 lb/A * 454,000 g/lb * 1A/40,468,564 cm2

 = 0.1963 mg/cm2  15 cm2 = 0.013 mg/mL * 1000 mL/L = 13.08 mg/L * 

76.5% = 10.0 mg a.i./L. 
Bacillus thuringiensis subspecies galleriae strain SDS-502 Page 16 of 42 

Biopesticides Registration Action Document 

 b. Nontarget Plants (Harmonized Guideline 885.4300) (MRID No. 485532-25)

The applicant submitted a scientific rationale to satisfy the data requirement for nontarget plants. 

Bacillus thuringiensis is well characterized with respect to effects on plants and is not taxonomically 

related to known plant pathogens. Therefore, adverse effects on nontarget plants (terrestrial and aquatic) 

are not expected to result from the proposed applications of Bacillus thuringiensis subspecies galleriae 

strain SDS-502. 

 c. Nontarget Insects (Harmonized Guideline 885.4340) and Honey Bees (Harmonized 

 Guideline 885.4380) (MRID Nos. 485532-04, 485532-26, 485532-27, 485532-28, 

 485532-29, 485532-30, 487168-03, and 489401-07; Rose 2013b)

The EPA reviewed submitted studies and information from the open literature. Most of the submitted 

insect studies (bioassays) provided limited information regarding potential dietary toxicity of the 

Cry8Da protein, extracted and purified from Bacillus thuringiensis subspecies galleriae strain SDS-502 

(Table 7 in Appendix A). These studies may have been of insufficient duration to note potential activity 

by an insecticide that must be ingested by susceptible insect larvae for toxic effects. Insect bioassays 

may be influenced by relative proportions of the different proteins within the crystal, thereby obscuring 

the role an individual toxin may play in insect toxicity. Variability in the composition and potency of 

crystals within the same strain may be caused by factors such as mobile genetic elements and nutritional 

requirements (Masson et al. 1998). At least seven different delta-endotoxins were identified in Bacillus 

thuringiensis subspecies galleriae (Chestukhina et al. 1994). 

It is not possible to determine whether these exposures were conducted at maximum hazard 

concentrations, based on submitted information about the protein levels in the test materials for some of 

the studies (MRID No. 485532-04). A couple of submitted studies used different protein extraction, 

purification and quantification methods and did not report the percentage of the Cry8Da protein. 

The EPA determined that the itemized studies below (studies b through f) are supplemental; however, all 

studies are useful for the risk assessment of Bacillus thuringiensis subspecies galleriae strain SDS-502 

because they provide a spectrum of the tested protein’s (Cry8Da) activity. The conclusions of these 

insect bioassays/studies were as follows: 

a. No sustained adverse effects are anticipated for populations of Hippodamia convergens (Order 

Coleoptera).

b. Potential Cry8Da toxicities were demonstrated for Plutella xylostella (Order Lepidoptera); 

defined as “weakly toxic” (cited by Asano et al. (2003), see MRID No. 485532-27). 

c. No Cry8Da toxicity was demonstrated for Bombyx mori (Oriental silkworm moth) or Spodoptera 

litura (Oriental leafworm moth). 

d. No Cry8Da toxicity was demonstrated for Leptinotarsa decemlineata (Colorado potato beetle). 

e. No Cry8Da toxicity to 4 species of adult parasitic Hymenoptera. 

f. High toxicity of purified Cry8Da from Bacillus thuringiensis subspecies galleriae strain SDS502 to the Emerald Ash Borer (Agrilus planipennis or Agrilus marcopoli) and to Scarabaeidae 

beetle “white grubs” (Anomala cuprea) was demonstrated in another submitted study. 
Bacillus thuringiensis subspecies galleriae strain SDS-502 Page 17 of 42 

Biopesticides Registration Action Document 

Asano et al. (2003) noted that other species of the Scarabaeidae (e.g., cupreous chafer, Anomala cuprea;

Japanese beetle, Popillia japonica Newman) are affected by other strains or subspecies of Bacillus 

thuringiensis (e.g., Bacillus thuringiensis subspecies galleriae NRRL B-4027 and Bacillus thuringiensis

subspecies japonensis) and other Cry8 genes were active against Cotinis spp. (June beetle). 

Although the Cry8Da protein was reported as weakly toxic to a lepidopteran pest, Plutella xylostella, 

another formulation with Bacillus thuringiensis subspecies galleriae was developed to control the wax 

moth (Galleriae spp.) in honeybee hives (Melin and Cozzi 1990). 

Based on these studies and the information presented above, effects to some insect species in the orders 

Coleoptera and Lepidoptera as a result of Bacillus thuringiensis subspecies galleriae strain SDS-502 

applications cannot be precluded. More refined estimates of the potential risk are not possible because 

(1) the majority of the studies were not conducted at maximum hazard concentrations and (2) there are 

uncertainties associated with the bioassays because of variation in the protein extraction methods used in 

those studies. These bioassays were conducted primarily to determine the potential insecticidal activity 

of Cry8Da protein. 

The applicant also submitted a study with honey bee larvae (Apis mellifera) exposed to Bacillus 

thuringiensis subspecies galleriae strain SDS-502 Cry8Da protein. Based on this study, the no observed 

effect concentration (NOEC) was 500 nanograms Bacillus thuringiensis subspecies galleriae strain 

SDS-502 Cry8Da protein/honeybee larval cell; however, the study was supplemental because of the 

uncertainty in dosing. However, a commercial formulation containing Bacillus thuringiensis subspecies

galleriae (strain not identified) with Lepidopteran activity was discussed in a review paper by Melin and 

Cozzi (1990). The formulation (no potency information provided) was developed to control the wax 

moth (Galleriae spp.) in bee hives, and the bacterium can be sprayed on the surface of the honeycomb or 

impregnated into the wax. Hives treated with Bacillus thuringiensis subspecies galleriae (strain and 

viability not provided) in a 40% sucrose solution showed no adverse effect on adult workers or colony 

life as determined by egg laying, brood production, brood capping or honey production (Melin and 

Cozzi 1990). Therefore, EPA does not have concerns as a result of exposure of this new active 

ingredient to honeybees 

 d. Freshwater Fish (Harmonized Guideline 885.4200), Freshwater Invertebrates 

(Harmonized Guideline 885.4240), and Estuarine/Marine Fish and Invertebrates 

 (Harmonized Guideline 885.4280) (MRID Nos. 485532-04, 485532-22, 485532-23, 

 485532-24, and 489401-07; Rose 2013b)

The applicant submitted scientific rationales in lieu of studies for freshwater fish and estuarine/marine 

organisms. Resubmitted information and data confirmed the taxonomic classification as Bacillus 

thuringiensis subspecies galleriae, with no known pathogenesis to fish species (U.S. EPA 1998) and a 

limited host range to certain insect orders. 

The applicant also submitted a study with Daphnia magna in which daphnids were exposed to water 

containing a range of nominal concentrations of the technical grade of the technical grade of the active 

ingredient (TGAI) for 21 days. Based on the percentage of the active ingredient in the EP, a direct 

application to a body of water equivalent to the EPA Standard Wetland would be approximately 10.0 mg 

a.i./L, which is less than the NOEC values for reproduction and growth (i.e., 50 mg/L) and for survival 

(i.e., 100 mg/L). Although high daphnid mortality and low neonate production were noted in the 

filtered treatment, the adverse effects did not affect the overall conclusions of the study and were 
Bacillus thuringiensis subspecies galleriae strain SDS-502 Page 18 of 42 

Biopesticides Registration Action Document 

attributed to low dissolved oxygen content, and anomalous values for conductivity and water hardness. 

Since exposure resulting from the proposed applications is well below the defined toxicity endpoints, 

adverse effects to freshwater invertebrates are not expected. 

2. Environmental Fate Data 

Microbial pesticides containing Bacillus thuringiensis readily break down in the environment, degrade 

within 48 hrs under ultraviolet light exposures (Myasnik et al. 2001), and have a half-life of 3.8 hours 

under normal sunlit conditions (USDA 1994). The microorganism can persist for several months in soil 

(Melin and Cozzi 1990), and certain Cry proteins may degrade within 32 days. Half-life values (DT50) 

ranged from 8.3 to 31.3 days (Mendelsohn et al. 2003). A spray-dried powder of Bacillus thuringiensis 

subspecies galleriae strain SDS-502 provided nearly 100% control of Anomala cuprea larvae as long as 

56 days after an initial application of 0.12 g/m2 (Asano et al. 2003). 

3. Threatened and Endangered Species Assessment 

The EPA has determined that no effects are anticipated for most nontarget species exposed to Bacillus 

thuringiensis subspecies galleriae strain SDS-502 as a result of the proposed labeled applications, 

including mammals, birds, terrestrial and aquatic plants, and freshwater and marine/estuarine animals. 

Therefore, a “No Effect” determination is made for direct and indirect effects to federally listed 

endangered and threatened (“listed”) mammals, birds, terrestrial and aquatic plants, and freshwater and 

marine/estuarine animals and for their designated critical habitat. 

Sustained population-level effects to nontarget insects are not anticipated; however, it is known that 

Bacillus thuringiensis subspecies galleriae can affect insects in the orders Coleoptera and Lepidoptera. 

Direct effects to individuals of listed insect species (USFWS 2013) cannot be precluded, nor can indirect 

effects to listed species that depend specifically on a listed insect. Additional analysis of the potential 

effects to these is necessary to make a determination for these species. 

V. ENVIRONMENTAL JUSTICE 

The EPA seeks to achieve environmental justice—the fair treatment and meaningful involvement of all 

people regardless of race, color, national origin, or income—with respect to the development, 

implementation, and enforcement of environmental laws, regulations, and policies. Fair treatment means 

that no group of people, including racial, ethnic, or socioeconomic groups, should bear a 

disproportionate share of the negative environmental consequences resulting from industrial, municipal, 

and commercial operations or the execution of federal, state, local, and tribal environmental programs 

and policies. Meaningful involvement means that (1) potentially affected community residents have an 

appropriate opportunity to participate in decisions about a proposed activity that will affect their 

environment and/or health; (2) the public’s contribution can influence the regulatory agency’s decision; 

(3) the concerns of all participants involved will be considered in the decision-making process; and (4) 

the decision-makers seek out and facilitate the involvement of those potentially affected. The EPA has 

this goal for all communities and persons across the United States. 

To help address potential environmental justice issues, the EPA seeks information on any groups or 

segments of the population who, as a result their location, cultural practices, or other factors, may have 

atypical, unusually high exposure to Bacillus thuringiensis subspecies galleriae strain SDS-502, 
Bacillus thuringiensis subspecies galleriae strain SDS-502 Page 19 of 42 

Biopesticides Registration Action Document 

compared to the general population. Please comment if you are aware of any subpopulations that may 

have atypical, unusually high exposure compared to the general population. 

For additional information regarding environmental justice issues, please visit the EPA’s website at 

http://www.epa.gov/compliance/environmentaljustice/index.html. 

VI. RISK MANAGEMENT DECISION 

Section 3(c)(5) of FIFRA permits for the registration of a pesticide provided that all the following 

determinations are made: 

 (1) Its composition is such as to warrant the proposed claims for it; 

 (2) Its labeling and other material required to be submitted comply with the 

 requirements of FIFRA; 

 (3) It will perform its intended function without unreasonable adverse effects on 

 the environment; AND 

(4) When used in accordance with widespread and commonly recognized 

 practice, it will not generally cause unreasonable adverse effects on the 

 environment. 

To satisfy criterion 1, the EPA understands that Bacillus thuringiensis subspecies galleriae strain SDS502 is well-known to have insecticidal capabilities. The EPA has no knowledge that would contradict 

the claims made on the Phyllom SDS-502 MP, Phyllom grubGONE! G, and Phyllom beetleGONE!TM

biological insecticide labels, and such pesticide products are not expected to cause unreasonable adverse 

effects on the environment when used according to their respective label instructions. Criterion 2 is 

satisfied by the product labels, as well as the data and information presented in this document. It is 

believed that the Bacillus thuringiensis subspecies galleriae strain SDS-502 pesticide products will not 

cause any unreasonable adverse effects on the environment, and Phyllom grubGONE! G and Phyllom 

beetleGONE!TM biological insecticide (end-use pesticide products), in particular, are likely to control 

certain beetle pests as claimed, satisfying criterion 3. Criterion 4 is satisfied in that the Bacillus 

thuringiensis subspecies galleriae strain SDS-502 pesticide products are not expected to cause 

unreasonable adverse effects when used according to label instructions. Therefore, the EPA believes 

Phyllom SDS-502 MP, Phyllom grubGONE! G, and Phyllom beetleGONE!TM biological insecticide, 

containing Bacillus thuringiensis subspecies galleriae strain SDS-502 as a new active ingredient, are 

eligible for registration under FIFRA section 3(c)(5) for the labeled uses. 

VII. ACTIONS REQUIRED OF THE REGISTRANT

A. Final Printed Labeling 

Before releasing pesticide products containing Bacillus thuringiensis subspecies galleriae strain SDS502 for shipment, the registrant is required to provide appropriate final printed labeling to the EPA. 
Bacillus thuringiensis subspecies galleriae strain SDS-502 Page 20 of 42 

Biopesticides Registration Action Document 

B. Terms of Registration 

The following items will be terms of the Phyllom SDS-502 MP (EPA File Symbol: 88347-R)

registration: 

(1) Storage Stability (Harmonized Guideline 830.6317): Within one year of registration, Phyllom, LLC, 

must provide the EPA with the results of a one-year storage stability study on Phyllom SDS-502 

MP. 

(2) Corrosion Characteristics (Harmonized Guideline 830.6320): Within one year of registration, 

Phyllom, LLC, must provide the EPA with the results of a one-year corrosion characteristics study 

on Phyllom SDS-502 MP. 

(3) pH (Harmonized Guideline 830.7000); Within six months of registration, Phyllom, LLC, must 

provide the EPA with the results of a pH study on Phyllom SDS-502 MP. 

(4) Producers of Phyllom SDS-502 MP will conduct the following production quality control measures 

to detect contamination or changes in the parent strain: 

 Spore preparations of Bacillus thuringiensis subsp. galleriae strain SDS-502 shall be produced 

by pure culture fermentation procedures with adequate quality control measures during 

production to detect any changes from the characteristics of the parent strain or contamination by 

other microorganisms. 

 Each lot of spore preparation, prior to the addition of other materials, shall be tested by 

subcutaneous injection of at least 1 million spores into each of 5 laboratory mice weighing 17 

grams to 23 grams. Such test shall show no evidence of infection or injury in the test animals 

when observed for 7 days following injection. 

 Spore preparations shall be free of the Bacillus thuringiensis β-exotoxin when tested with the fly 

larvae toxicity test (“Microbial Control of Insects and Mites,” R.P.M. Bond et al., p. 280 ff., 

1971). This specification can be satisfied either by determining that each master seed lot brought 

into production is a Bacillus thuringiensis strain that does not produce β-exotoxin under 

standardized manufacturing conditions or by periodically determining that β-exotoxin 

synthesized during spore production is eliminated by the subsequent spore-harvesting procedure. 

 

(5) Producers of Phyllom SDS-502 MP will maintain records of the quality control tests described 

directly above (in #4) for a period of at least five years from the date each batch is released for 

production. 
Bacillus thuringiensis subspecies galleriae strain SDS-502 Page 21 of 42 

Biopesticides Registration Action Document 

The following items will be terms of the Phyllom grubGONE! G (EPA File Symbol: 88347-E)

registration: 

(1) Storage Stability (Harmonized Guideline 830.6317): Within one year of registration, Phyllom, LLC, 

must provide the EPA with the results of a one-year storage stability study on Phyllom grubGONE! 

G. 

(2) Corrosion Characteristics (Harmonized Guideline 830.6320): Within one year of registration, 

Phyllom, LLC, must provide the EPA with the results of a one-year corrosion characteristics study 

on Phyllom grubGONE! G. 

The following items will be terms of the Phyllom beetleGONE!TM biological insecticide (EPA File 

Symbol: 88347-G) registration: 

(1) Storage Stability (Harmonized Guideline 830.6317): Within one year of registration, Phyllom, LLC, 

must provide the EPA with the results of a one-year storage stability study on Phyllom 

beetleGONE!TM biological insecticide. 

(2) Corrosion Characteristics (Harmonized Guideline 830.6320): Within one year of registration, 

Phyllom, LLC, must provide the EPA with the results of a one-year corrosion characteristics study 

on Phyllom beetleGONE!TM biological insecticide. 

C. Reporting of Adverse Effects and Hypersensitivity Incidents 

Notwithstanding the information stated in the previous sections, it should be clearly understood that 

certain specific data are required to be reported to the EPA as a requirement for maintaining the federal 

registration for a pesticide product. A brief summary of these types of data are described below. 

Reports of all incidents of adverse effects to the environment must be submitted to the EPA under the 

provisions stated in FIFRA section 6(a)(2). Additionally, all incidents of hypersensitivity (including both 

suspected and confirmed incidents) must be reported to the EPA under the provisions of 40 C.F.R. § 

158.2140(d). 
Bacillus thuringiensis subspecies galleriae strain SDS-502 Page 22 of 42 

Biopesticides Registration Action Document 

VIII. GLOSSARY OF ACRONYMS AND ABBREVIATIONS 

A/cm2 acre per square centimeter 

a.i. active ingredient 

BRAD Biopesticides Registration Action Document 

C.F.R. Code of Federal Regulations 

cfu colony-forming units 

cfu/kg colony-forming units per kilogram 

cfu/mL colony-forming units per milliliter 

cm centimeter 

EC environmental concentration 

EC50 half maximal effective concentration 

EDSP Endocrine Disruptor Screening Program 

EP end-use pesticide product 

EPA United States Environmental Protection Agency 

FFDCA Federal Food, Drug, and Cosmetic Act 

FIFRA Federal Insecticide, Fungicide, and Rodenticide Act 

FR Federal Register 

g/A grams per acre 

g/lb grams per pound 

g/m2

 grams per square meter 

lb/A pounds per acre 

lb/ft3

 pounds per cubic foot 

LC50 median lethal concentration. A statistically derived concentration of a substance that can be 

expected to cause death in 50% of test animals. It is usually expressed as the weight of substance 

per weight or volume of water, air, or feed (e.g., mg/L, mg/kg, or ppm). 

LD50 median lethal dose. A statistically derived single dose that can be expected to cause death 

 in 50% of the test animals when administered by the route indicated (oral, dermal, or 

 inhalation). It is expressed as a weight of substance per unit weight of animal (e.g., mg/kg). 

μg/μL micrograms per microliter 

μg/mL micrograms per milliliter 

mg/cm2

 milligrams per square centimeter 

mg/kg milligrams per kilogram 

mg/L milligrams per liter 

mg/mL milligrams per milliliter 

mL/L milliliters per liter 

mm millimeter 

MP manufacturing-use pesticide product 

MPCA microbial pest control agent 

MRID No. Master Record Identification Number 

ng nanogram 

NIOSH National Institute for Occupational Safety and Health 

NOEC no observed effect concentration 

OPP Office of Pesticide Programs 

PC Code Pesticide Chemical Code 

PPE personal protective equipment 

ppm parts per million 

QC quality control 

TGAI technical grade of the active ingredient 

U.S. United States 

USDA United States Department of Agriculture 

USFWS United States Fish and Wildlife Service
Bacillus thuringiensis subspecies galleriae strain SDS-502 Page 23 of 42 

Biopesticides Registration Action Document 

IX. BIBLIOGRAPHY 

A. Studies Submitted to Support the Bacillus thuringiensis subspecies galleriae strain SDS-502 

 Pesticide Product Registrations 

MRID No. Study Information

485532-01 Libs J, Rose R. 2010. Phyllom SDS-502 MP, Product Identity and Characterization. 

Unpublished study prepared by Phyllom, LLC, 10 pages. 

485532-02 Libs J, Rose R. 2010. Phyllom SDS-502 MP, Manufacturing Process. Unpublished study 

prepared by Phyllom, LLC, 6 pages. 

485532-03 Libs J, Rose R. 2010. Phyllom SDS-502 MP, Discussion of Formation of Unintentional 

Ingredients. Unpublished study prepared by Phyllom, LLC, 6 pages. 

485532-04 Libs J, Rose R. 2010. Phyllom SDS-502 MP, Analysis of Samples. Unpublished study 

prepared by Phyllom, LLC, 14 pages. 

485532-05 Libs J, Rose R. 2011. Phyllom SDS-502 MP, Certification of Limits. Unpublished study 

prepared by Phyllom, LLC, 2 pages. 

485532-08 

Munley S. 2011. Bacillus thuringiensis subsp. galleriae, Strain SDS-502: Acute Oral 

Toxicity/Pathogenicity Study in Rats. Project Number: DUPONT/20580 16248 1013. 

Unpublished study prepared by E.I. du Pont de Nemours and Company and Phyllom, 

LLC, 51 pages. 

485532-09 

Munley S. 2011. Bacillus thuringiensis subsp. galleriae, Strain SDS-502: Acute 

Pulmonary Toxicity/Pathogenicity Study in Rats. Project Number: DUPONT/20579 

16248 1014. Unpublished study prepared by E.I. du Pont de Nemours and Company and 

Phyllom, LLC, 56 pages. 

485532-10 

Munley S. 2011. Bacillus thuringiensis subsp. galleriae, Strain SDS-502: Acute 

Intraperitoneal Injection Toxicity/Pathogenicity Study in Rats. Project Number: 

DUPONT/20581 16248 1015. Unpublished study prepared by E.I. du Pont de Nemours 

and Company and Phyllom, LLC, 49 pages. 

485532-11 Libs J, Rose R. 2008. Phyllom SDS-502 MP, Spore Clearance. Unpublished study 

prepared by Phyllom, LLC, 27 pages. 
Bacillus thuringiensis subspecies galleriae strain SDS-502 Page 24 of 42 

Biopesticides Registration Action Document 

MRID No. Study Information

485532-12 Libs J, Rose R. 2010. Phyllom SDS-502 MP, Hypersensitivity Incidents. Unpublished 

study prepared by Phyllom, LLC, 2 pages. 

485532-13 Libs J, Rose R. 2010. Phyllom SDS-502 MP, Cell Culture (Waiver Request). Unpublished 

study prepared by Phyllom, LLC, 2 pages. 

485532-14 Libs J, Rose R. 2010. Phyllom SDS-502 MP, Acute Oral Toxicity (Waiver Request). 

Unpublished study prepared by Phyllom, LLC, 3 pages. 

485532-15 Libs J, Rose R. 2010. Phyllom SDS-502 MP, Acute Dermal Toxicity (Waiver Request). 

Unpublished study prepared by Phyllom, LLC, 3 pages. 

485532-17 Kuhn J. 2006. Acute Eye Irritation Study in Rabbits – SDS-502 TGAI (Final Report). 

Project Number: 9645/06. Unpublished study prepared by Stillmeadow, Inc., 16 pages. 

485532-18 

Kuhn J. 2006. SDS-502 TGAI - Acute Dermal Toxicity Study in Rabbits with a Microbial 

Pest Control Agent (MPCA) (Final Report). Project Number: 9644/06. Unpublished study 

prepared by Stillmeadow, Inc., 12 pages. 

485532-19 

Borchert J. 2006. Avian Oral Limit Toxicity Test with Bacillus thuringiensis subsp. 

galleriae strain SDS-502 in Mallard Ducks (Anas platyrhynchos) (Final Report). Project 

Number: 06001. Unpublished study prepared by Genesis Laboratories, Inc., 58 pages. 

485532-20 Libs J, Rose R. 2010. Phyllom SDS-502 MP, Avian Inhalation Toxicity/Pathogenicity 

(Waiver Request). Unpublished study by Phyllom, LLC, 3 pages. 

485532-21 Libs J, Rose R. 2010. Phyllom SDS-502 MP, Wild Mammal Toxicity/Pathogenicity 

(Waiver Request). Unpublished study prepared by Phyllom, LLC, 3 pages. 

485532-22 Libs J, Rose R. 2010. Phyllom SDS-502 MP, Freshwater Fish Toxicity/Pathogenicity 

(Waiver Request). Unpublished study prepared by Phyllom, LLC, 3 pages. 
Bacillus thuringiensis subspecies galleriae strain SDS-502 Page 25 of 42 

Biopesticides Registration Action Document 

MRID No. Study Information

485532-23 

Hartwell T. 2009. Bacillus thuringiensis subsp. galleriae Strain SDS-502 – Microbial Pest 

Control Agent (MPCA) Freshwater Aquatic Invertebrate Test with Daphnia magna (Final 

Report). Project Number: 13048/09. Unpublished study prepared by Stillmeadow, Inc., 27 

pages. 

485532-24 

Libs J, Rose R. 2011. Phyllom SDS-502 MP, Estuarine/Marine Fish Testing and 

Estuarine/Marine Invertebrate Testing (Waiver Request). Unpublished study prepared by 

Phyllom, LLC, 3 pages. 

485532-25 Libs J, Rose R. 2011. Phyllom SDS-502 MP, Nontarget Plant Testing (Waiver Request). 

Unpublished study prepared by Phyllom, LLC, 3 pages. 

485532-26 

Porch J, Krueger H. 2011. Bacillus thuringiensis subsp. galleriae Strain SDS-502 TGAI – 

A Dietary Pathogenicity and Toxicity Study with Ladybird Beetle (Hippodamia 

convergens) (Final Report). Project Number: 702/101. Unpublished study prepared by 

Wildlife International, Ltd., 31 pages. 

485532-27 

Asano S, Yamashita C, Iizuka T, Takeuchi K, Yamanaka S, Cerf D, Yamamoto T. 2003. 

A Strain of Bacillus thuringiensis subsp. galleriae Containing a Novel Cry8 Gene Highly 

Toxic to Anomala cuprea (Coleoptera: Scarabaeidae). Biological Control 28:191–196. 

485532-28 

Libs J, Rose R. 2010. Phyllom SDS-502 MP, Bacillus thuringiensis subsp. galleriae, 

Strain SDS-502 Toxicity to the Colorado Potato Beetle (Leptinotarsa decemlineata) 

(Coleoptera: Chrysomelidae), Acute Nontarget Insect Testing, Tier I. Project Number: 

PHY/SDS502/GRUB. Unpublished study prepared by the University of Maryland, 5 

pages. 

485532-29 

Libs J. 2010. Phyllom SDS-502 MP, Bacillus thuringiensis subsp. galleriae, Strain SDS502 Toxicity to the Spotted Cucumber Beetle/Southern Corn Rootworm (Diabrotica 

undecimpunctata howardi) (Coleoptera: Chrysomelidae), Acute Nontarget Insect Testing, 

Tier I. Unpublished study prepared by Phyllom, LLC, 4 pages. 

485532-30 

Richards R. 2006. Evaluation of Dietary Effects of SDS-502 Cry8Da on Larval Honeybee 

Development (Apis mellifera L.). Project Number: CAR/152/05. Unpublished study 

prepared by California Agricultural Research, Inc., 37 pages. 
Bacillus thuringiensis subspecies galleriae strain SDS-502 Page 26 of 42 

Biopesticides Registration Action Document 

MRID No. Study Information

485698-01 Libs J, Rose R. 2011. Phyllom GrubGone EP, Product Identity and Characterization. 

Unpublished study prepared by Phyllom, LLC, 2 pages. 

485698-02 Libs J, Rose R. 2011. Phyllom GrubGone EP, Manufacturing Process. Unpublished study 

prepared by Phyllom, LLC, 4 pages. 

485698-03 Libs J, Rose R. 2011. Phyllom GrubGone EP, Discussion of Formation of Unintentional 

Ingredients. Unpublished study prepared by Phyllom, LLC, 4 pages. 

485698-04 Libs J, Rose R. 2011. Phyllom GrubGone EP, Analysis of Samples. Unpublished study 

prepared by Phyllom, LLC, 11 pages. 

485698-05 Libs J, Rose R. 2011. Phyllom GrubGone EP, Certification of Limits. Unpublished study 

prepared by Phyllom, LLC, 2 pages. 

485698-08 Libs J, Rose R. 2011. Phyllom GrubGone EP, Hypersensitivity Incidents. Unpublished 

study prepared by Phyllom, LLC, 2 pages. 

485698-09 Libs J, Rose R. 2011. Phyllom GrubGone EP, Acute Oral Toxicity (Waiver Request). 

Unpublished study prepared by Phyllom, LLC, 4 pages. 

485698-10 Libs J, Rose R. 2011. Phyllom GrubGone EP, Acute Dermal Toxicity (Waiver Request). 

Unpublished study prepared by Phyllom, LLC, 4 pages. 

485698-12 Kuhn J. 2006. SDS-502 End Use: Acute Eye Irritation Study in Rabbits (Final Report). 

Project Number: 9643/06. Unpublished study prepared by Stillmeadow, Inc., 16 pages. 

485698-13 

Kuhn J. 2006. SDS-502 End Use: Acute Dermal Toxicity Study in Rabbits with a 

Microbial Pest Control Agent (MPCA) (Final Report). Project Number: 9642/06. 

Unpublished study prepared by Stillmeadow, Inc., 12 pages. 

487168-01 Libs J. 2012. Physical and Chemical Characteristics for Phyllom SDS-502 MP, Bacillus 

thuringiensis subsp. galleriae. Unpublished study prepared by Phyllom, LLC, 15 pages. 
Bacillus thuringiensis subspecies galleriae strain SDS-502 Page 27 of 42 

Biopesticides Registration Action Document 

MRID No. Study Information

487168-02 Libs J. 2012. Physical and Chemical Characteristics for Phyllom GrubGONE Granular 

(G). Unpublished study prepared by Phyllom, LLC, 15 pages. 

487168-03 

Bauer L, Londono D. 2012. Acute Nontarget Insect Testing, Tier I: Parasitic 

Hymenoptera Wasps: Tetrastichus planipennisi, Oobius agrili, Spathius agrili, and 

Atanycolus cappaerti. Unpublished study prepared by the U.S. Forest Service, 9 pages. 

489401-01 Libs J. 2012. Phyllom boreGONE! EP, Product Identity and Characterization. 

Unpublished study prepared by Phyllom, LLC, 3 pages. 

489401-02 Libs J. 2012. Phyllom boreGONE! Biological Insecticide, Manufacturing Process. 

Unpublished study prepared by Phyllom, LLC, 4 pages. 

489401-03 Libs J. 2012. Phyllom boreGONE! Biological Insecticide, Discussion of Formation of 

Unintentional Ingredients. Unpublished study prepared by Phyllom, LLC, 3 pages. 

489401-04 Libs J. 2012. Phyllom boreGONE! EP, Analysis of Samples. Unpublished study prepared 

by Phyllom, LLC, 10 pages. 

489401-05 Libs J. 2012. Phyllom boreGONE! EP, Certification of Limits. Unpublished study 

prepared by Phyllom, LLC, 2 pages. 

489401-06 Libs J. 2012. Physical and Chemical Properties for Phyllom boreGONE! Biological 

Insecticide Data Requirements. Unpublished study prepared by Phyllom, LLC, 12 pages. 

489401-07 

Rose R. 2012. Product-Specific Data for the End-Use Pesticide Product, Phyllom 

grubGONE! Granular (G), and the Manufacturing-Use Pesticide Product, Phyllom SDS502 MP. Unpublished study prepared by Robert I. Rose, 8 pages. 

489401-08 

Libs J. 2012. Phyllom Bacillus thuringiensis subsp./var. galleriae, Strain SDS-502, 

Primary Powder TGAI/MUP/MP – Rationale/Clearance Demonstration of Lack of, or No 

Infectivity in Studies Conducted for Registration of Phyllom SDS-502 MP. Unpublished 

study prepared by Phyllom, LLC, 9 pages. 
Bacillus thuringiensis subspecies galleriae strain SDS-502 Page 28 of 42 

Biopesticides Registration Action Document 

MRID No. Study Information

489731-01 

Doig A. 2012. Acute Inhalation Toxicity in Rats: Bacillus thuringiensis serovar galleriae 

SDS-502 (BTG SDS-502) TGAI Powder. Project Number: 16757/12. Unpublished study 

prepared by Stillmeadow, Inc., 17 pages. 

489731-02 Libs J. 2012. Phyllom boreGONE! Biological Insecticide, Hypersensitivity Incidents. 

Unpublished study prepared by Phyllom, LLC, 3 pages. 

489731-03 Libs J. 2012. Phyllom boreGONE! Biological Insecticide End-Use Product, Acute Oral 

Toxicity. Unpublished study prepared by Phyllom, LLC, 3 pages. 

489731-04 Libs J. 2012. Phyllom boreGONE! Biological Insecticide End-Use Product, Acute Dermal 

Toxicity. Unpublished study prepared by Phyllom, LLC, 4 pages. 

489731-05 Libs J. 2012. Phyllom boreGONE! Biological Insecticide End-Use Product, Acute 

Inhalation Toxicity. Unpublished study prepared by Phyllom, LLC, 4 pages. 

489731-06 Libs J. 2012. Phyllom boreGONE! Biological Insecticide End-Use Product, Acute Eye 

Irritation. Unpublished study prepared by Phyllom, LLC, 3 pages. 

489731-07 Libs J. 2012. Phyllom boreGONE! Biological Insecticide End-Use Product, Primary 

Dermal Irritation. Unpublished study prepared by Phyllom, LLC, 3 pages. 

489731-08 Libs J. 2012. Phyllom grubGONE! Granular (G) End-Use Product, Acute Inhalation 

Toxicity. Unpublished study prepared by Phyllom, LLC, 4 pages. 

490940-01 

Benzon G, Finkenbiner C. 2013. Phyllom Bacillus thuringiensis subsp. galleriae, Strain 

SDS-502 MP (TGAI) Primary Powder Beta-Exotoxin Bioassay on Musca domestica

(House Fly Larvae), Diptera: Muscidae. Project Number: PH13001, PH13002. 

Unpublished study prepared by Benzon Research, 14 pages. 

490940-02 

Libs J. 2013. Phyllom Manufacturing Process Quality Control Supplement to MRID No. 

485532-02 for Phyllom’s Bacillus thuringiensis subsp. galleriae, Strain SDS-502, MP 

(TGAI). Unpublished study prepared by Phyllom LLC, 5 pages. 
Bacillus thuringiensis subspecies galleriae strain SDS-502 Page 29 of 42 

Biopesticides Registration Action Document 

MRID No. Study Information

490940-03 

Doig A. 2013. Phyllom, LLC Bacillus thuringiensis subsp. galleriae, Strain SDS-502, MP 

(TGAI) Primary Powder MPCA Subcutaneous Injection Safety Test in Mice. Project 

Number: 17193/13. Unpublished study prepared by Stillmeadow, Inc., 16 pages. 

490940-04 

Matthews T. 2013. Phyllom Bacillus thuringiensis subsp. galleriae, Strain SDS-502, MP 

(TGAI) Primary Colony Forming Units (CFU) and Culture Purity Quality Control (QC) 

Analyses. Project Number: PHY/6/13/1. Unpublished study prepared by San Diego State 

University, 12 pages. 

490940-05 

Matthews T. 2013. Phyllom Bacillus thuringiensis subsp. galleriae, Strain SDS-502, 

grubGONE! Granular (G) Colony Forming Units (CFU) and Culture Purity Quality 

Control (QC) Analyses. Project Number: PHY/6/13/3. Unpublished study prepared by 

San Diego State University, 9 pages. 

490940-06 

Matthews T. 2013. Phyllom Bacillus thuringiensis subsp. galleriae, Strain SDS-502, 

boreGONE!/beetleGONE! Colony Forming Units (CFU) and Culture Purity Quality 

Control (QC) Analyses. Project Number: PHY/6/13/2. Unpublished study prepared by 

San Diego State University, 13 pages. 

B. Environmental Protection Agency Risk Assessment Memoranda 

U.S. EPA. 2013a. Bacillus thuringiensis subsp. galleriae strain SDS-502. Memorandum from J.V. 

Gagliardi, Ph.D. through J.L. Kough, Ph.D. to J. Kausch, dated April 30, 2013. 

U.S. EPA. 2013b. Evaluation of a new microbial pesticide, Phyllom boreGONE! Biological Insecticide 

(a.i.: Bacillus thuringiensis subspecies galleriae strain SDS-502) for use in experimental testing 

to control Emerald Ash Borer (Agrilus planipennis) (EPA File Symbol: 88347-EUP-R). 

Memorandum from G. Tomimatsu, Ph.D. through S. Borges to J. Kausch, dated May 7, 2013. 

U.S. EPA. 2013c. Environmental risk assessment for the FIFRA section 3 registration of Bacillus 

thuringiensis subsp. galleriae strain SDS-502 (EPA File Symbols: 88347-R, 88347-E, and 

88347-G). Memorandum from G. Tomimatsu, Ph.D. through S. Borges to J. Kausch, dated May 

14, 2013. 

U.S. EPA. 2012a. Bacillus thuringiensis serotype galleria strain SDS-502. Memorandum from J.V. 

Gagliardi, Ph.D. through J.L. Kough, Ph.D. to J. Kausch, dated December 18, 2012. 

C. Other References 

Asano S, Yamashita C, Iizuka T, Takeuchi K, Yamanaka S, Cerf D, Yamamoto T. 2003. A strain of 

 Bacillus thuringiensis subsp. galleriae containing a novel cry8 gene highly toxic to Anomala 

 cuprea (Coleoptera: Scarabaeidae). Biological Control 28:191–196 (also see MRID No. 

 485532-27). 
Bacillus thuringiensis subspecies galleriae strain SDS-502 Page 30 of 42 

Biopesticides Registration Action Document 

Bravo A. 2007. Mode of action of Bacillus thuringiensis Cry and Cyt toxins and their potential for 

 insect control. Toxicon 49(4):423–435. 

Chestukhina GG, Kostina LI, Zalunin IA, Revina LP, Mikhailova AL, Stepanov VM. 1994. Production 

of multiple delta-endotoxins by Bacillus thuringiensis: delta-endotoxins produced by strains of 

the subspecies galleriae and wuhanensis. Canadian Journal of Microbiology 40:1026–1034. 

Damgaard PH, Abdel-Hameed A, Eilenberg J, Smits PH. 1998. Natural occurrence of Bacillus 

thuringiensis on grass foliage. World Journal of Microbiology & Technology 14:239–242. 

 Federici BA. 2005. Insecticidal bacteria: An overwhelming success for invertebrate pathology. 

Journal of Invertebrate Pathology 89(2005):30–38. 

Gao M, Li R, Dai S, Wu Y, Yi D. 2008. Diversity of Bacillus thuringiensis strains from soils in China 

and their pesticidal activities. Biological Control 44(3):380–388. 

Masson L, Erlandson M, Puzstai-Carey M, Brousseau R, Juárez-Pérez V, Frutos R. 1998. A holistic 

approach for determining the entomopathogenic potential of Bacillus thuringiensis strains. 

Applied and Environmental Microbiology 64(12):4782–4788. 

Melin BE, Cozzi EM. 1990. Safety to nontarget invertebrates of Lepidopteran strains of Bacillus 

thuringiensis and their delta-endotoxins. Pp. 149–167 In Laird M, Lacey LA, Davidson EWD, 

Eds., Safety of Microbial Insecticides. CRC Press, Boca Raton, Florida. 

Mendelsohn M, Kough J, Vaituzis Z, Matthews K. 2003. Are Bt crops safe? Nature Biotechnology 

21(9):1003–1009. 

Mizuki E, Ichimatsu T, Hwang S-H, Park YS, Saitoh H, Higuchi K, Ohba M. 1999. Ubiquity of Bacillus 

thuringiensis on phylloplanes or arboreous and herbaceous plants in Japan. Journal of Applied 

Microbiology 86:979–984. 

Myasnik M, Manasherob R, Ben-Dov E, Zaritsky A, Margalith Y, Barak Z. 2001. Comparative 

sensitivity to UV-B radiation of two Bacillus thuringiensis subspecies and other Bacillus sp. 

Current Microbiology 43:140–143. 

 

Rose RI. 2013a. January 11, 2013 Letter from R.I. Rose, Ph.D., Authorized Agent for Phyllom, LLC, to 

the EPA (re: Culture Collection Certificate from the Japan International Patent Organism 

Depository, National Institute of Technology and Evaluation; Additional Product Identity 

Information on Bacillus thuringiensis subspecies galleriae strain SDS-502; and Revised 

Experimental Use Permit Description Forms). 

Rose RI. 2013b. March 30, 2013 Letter from R.I. Rose, Ph.D., Authorized Agent for Phyllom, LLC, to 

the EPA (re: Response to the Meeting Minutes/Action Items from the February 28, 2013 

Meeting between Phyllom. LLC, and the EPA and the Deficiencies Described in a 

March 30, 2013 90-day Preliminary Technical Screening Letter from the EPA). 

USDA. 1994. Extension Service, National Agricultural Pesticide Impact Assessment Program. 
Bacillus thuringiensis subspecies galleriae strain SDS-502 Page 31 of 42 

Biopesticides Registration Action Document 

U.S. EPA. 2012b. Chapter 7 of the Label Review Manual (Precautionary Statements). Available from 

http://www.epa.gov/oppfead1/labeling/lrm/chap-07.pdf. 

U.S. EPA. 1998. Reregistration Eligibility Decision for Bacillus thuringiensis (List D – Case 0247). 

Available from http://www.epa.gov/oppsrrd1/REDs/0247.pdf. 

U.S. EPA. 1996. Microbial Pesticide Test Guidelines – Background for Residue Analysis of Microbial 

Pest Control Agents (OPPTS 885.2000). Available from 

http://www.epa.gov/ocspp/pubs/frs/publications/Test_Guidelines/series885.htm. 

USFWS. 2013. Endangered Species. Available from http://www.fws.gov/endangered/. 

World Health Organization. 2011. Guidelines for Drinking-water Quality (Fourth Edition). Available 

from http://whqlibdoc.who.int/publications/2011/9789241548151_eng.pdf. 
Bacillus thuringiensis subspecies galleriae strain SDS-502 Page 32 of 42 

Biopesticides Registration Action Document 

APPENDIX A. MICROBIAL PESTICIDES DATA REQUIREMENTS 

(40 C.F.R. PART 158 – SUBPART V) 

TABLE 1. Product Analysis Data Requirements for the Technical Grade of the Active Ingredient (TGAI), Bacillus thuringiensis 

subspecies galleriae strain SDS-502, and Its Manufacturing-Use Pesticide Product (MP), Phyllom SDS-502 MP (40 C.F.R. § 158.2120) 

Harmonized 

Guideline 

Number 

Data Requirement 

Results MRID No. or 

Other 

TGAI MP Reference 

885.1100 Product Identity N/A 

Submitted data fulfill the requirement 

for product identity. Phyllom SDS-502 

MP contains 90.0% by weight Bacillus 

thuringiensis subspecies galleriae strain 

SDS-502 fermentation solids, spores, 

and insecticidal toxins (contains a 

minimum of 1 x 1010 cfu per gram). 

485532-01 

Rose (2013a) 

Rose (2013b) 

885.1200 Manufacturing Process 

Submitted data fulfill the requirement for manufacturing process. As a term 

of the Phyllom SDS-502 MP registration, all producers of Phyllom SDS502 MP will conduct certain production quality control measures to 

detect contamination or changes to the parent strain and will maintain 

records of these quality control tests for a period of at least five years 

from the date each batch is released. 

485532-02 

490940-02 

490940-03 

Rose (2013b) 

885.1250 

Deposition of a Sample in 

a Nationally Recognized 

Culture Collection 

Bacillus thuringiensis subspecies 

galleriae strain SDS-502 is on 

deposit with the Japan 

International Patent Organism 

Depository, National Institute of 

Technology and Evaluation in 

Tsukuba-shi, Japan under 

Accession Number FERM BP7667. 

N/A 

485532-01 

Rose (2013a) 

Rose (2013b) 

885.1300 

Discussion of Formation 

of Unintentional 

Ingredients 

Submitted data fulfill the requirement for discussion of formation of 

unintentional ingredients. As a term of the Phyllom SDS-502 MP 

registration, all producers of Phyllom SDS-502 MP will conduct certain 

production quality control measures to detect contamination or changes 

to the parent strain and will maintain records of these quality control 

tests for a period of at least five years from the date each batch is 

released. 

485532-03 

490940-02 

490940-03 

Rose (2013b) 

885.1400 Analysis of Samples Submitted data fulfill the requirement for analysis of samples. 485532-04 

490940-04 

885.1500 Certification of Limits N/A 

Limits listed on the confidential 

statement of formula are 

adequate/acceptable. 

485532-05 

Rose (2013b) 
Bacillus thuringiensis subspecies galleriae strain SDS-502 Page 33 of 42 

Biopesticides Registration Action Document 

TABLE 2. Product Analysis Data Requirements for the End-Use Pesticide Products (EPs), Phyllom grubGONE! G and 

beetleGONE!TM biological insecticide (40 C.F.R. § 158.2120)

Harmonized 

Guideline 

Number 

Data Requirement 

Results MRID No. or 

Other 

Phyllom grubGONE! G Reference Phyllom beetleGONE!TM biological 

insecticide 

885.1100 Product Identity 

Submitted data fulfill the requirement 

for product identity. Phyllom 

grubGONE! G contains 9.0% by 

weight Bacillus thuringiensis

subspecies galleriae strain SDS-502 

fermentation solids, spores, and 

insecticidal toxins (contains a minimum 

of 1 x 109

 cfu per gram). 

Submitted data fulfill the requirement 

for product identity. Phyllom 

beetleGONE!TM biological insecticide 

contains 76.5% by weight Bacillus 

thuringiensis subspecies galleriae 

strain SDS-502 fermentation solids, 

spores, and insecticidal toxins 

(contains a minimum of 0.85 x 1010

cfu per gram). 

485698-011

489401-012

Rose (2013b)1,2 

885.1200 Manufacturing Process Submitted data fulfill the requirement for manufacturing process. 

485698-021

489401-022

Rose (2013b)1,2 

885.1250 

Deposition of a 

Sample in a Nationally 

Recognized Culture 

Collection 

N/A N/A 

885.1300 

Discussion of 

Formation of 

Unintentional 

Ingredients 

Submitted data fulfill the requirement for discussion of formation of 

unintentional ingredients.

485698-031

489401-032

Rose (2013b)1,2

885.1400 Analysis of Samples Submitted data fulfill the requirement for analysis of samples.

485698-041

490940-051

489401-042

490940-062

885.1500 Certification of Limits Limits listed on the confidential statement of formula are adequate/acceptable. 

485698-051

489401-052

Rose (2013b)1,2 

1

 Study supporting Phyllom grubGONE! G, EPA File Symbol 88347-E 

2

 Study supporting Phyllom beetleGONE!TM biological insecticide, EPA File Symbol 88347-G
Bacillus thuringiensis subspecies galleriae strain SDS-502 Page 34 of 42 

Biopesticides Registration Action Document 

TABLE 3. Physical and Chemical Characteristics for the Technical Grade of the Active Ingredient (TGAI), Bacillus thuringiensis 

subspecies galleriae strain SDS-502, and Its Manufacturing-Use Pesticide Product (MP), Phyllom SDS-502 MP (40 C.F.R. § 158.2120) 

Harmonized 

Guideline 

Number 

Data Requirement 

Results MRID No. or 

Other 

Reference TGAI MP 

830.6302 Color Light brown, beige, or tan 

N/A 

487168-01 

830.6303 Physical State Flour-like powder 487168-01 

Rose (2013b) 

830.6304 Odor Mild earthy, slightly yeastlike 

487168-01 

830.6313 

Stability to Normal and Elevated 

Temperatures, Metals, and Metal 

Ions 

Active ingredient is not 

expected to be stable at 

elevated temperatures. 

830.6317 Storage Stability 

Study is in progress. As a term of the Phyllom SDS-502 MP 

registration, the EPA is requiring that the results of a oneyear storage stability study be submitted within one year of 

registration.

487168-01 

Rose (2013b) 

830.6319 Miscibility 

N/A 

Soluble when mixed in water or 

oil but settles out over time. 487168-01 

830.6320 Corrosion Characteristics 

Study is in progress. As a term of 

the Phyllom SDS-502 MP 

registration, the EPA is 

requiring that the results of a 

one-year storage corrosion 

characteristics be submitted 

within one year of registration.

487168-01 

Rose (2013b) 

830.7000 pH 

As a term of the Phyllom 

SDS-502 MP registration, 

the EPA is requiring the 

results of a pH study. 

N/A 

487168-01 

830.7100 Viscosity N/A 

Not required because Phyllom 

SDS-502 MP is not a liquid form 

of microbial pesticide (refer to 

test note #5 of 40 C.F.R. § 

158.2120(d)). 

830.7300 Density/Relative Density/Bulk 

Density (Specific Gravity) 25–35 lb/ft3 N/A 
Bacillus thuringiensis subspecies galleriae strain SDS-502 Page 35 of 42 

Biopesticides Registration Action Document 

TABLE 4. Physical and Chemical Characteristics for the End-Use Pesticide Product (EPs), Phyllom grubGONE! G and Phyllom 

beetleGONE!TM biological insecticide (40 C.F.R. § 158.2120)

Harmonized 

Guideline 

Number 

Data Requirement 

Results MRID No. or Other 

Reference Phyllom grubGONE! G Phyllom beetleGONE!TM

biological insecticide

830.63023 Color Tan or light brown 

487168-021

489401-06 830.6303 2 3 Physical State Dry granules, ~ 1 mm in 

diameter 

Wettable powder, less than 

100 mesh 

830.63043 Odor Mild, earthy 

830.6313 

Stability to Normal and 

Elevated Temperatures, 

Metals, and Metal Ions 

N/A N/A 

830.6317 Storage Stability 

Studies are in progress. As a term of the Phyllom 

grubGONE! G and Phyllom beetleGONE!TM biological 

insecticide registrations, the EPA is requiring that the 

results of one-year storage stability studies be 

submitted within one year of registration.

487168-021

489401-062

Rose (2013b) 

830.6319 Miscibility 

When mixed with water, the EPs form fine-particulate 

suspensions that settle out over time and easily redistribute in the water column when agitated. 

487168-021

489401-062

830.6320 Corrosion Characteristics 

Studies are in progress. As a term of the Phyllom 

grubGONE! G and Phyllom beetleGONE!TM biological 

insecticide registrations, the EPA is requiring that the 

results of one-year corrosion characteristics studies be 

submitted within one year of registration.

487168-021

489401-062

Rose (2013b) 

830.7000 pH N/A N/A 

830.7100 Viscosity 

Not required because the EPs are not liquid forms of 

microbial pesticides (refer to test note #5 of 40 C.F.R. § 

158.2120(d)). 487168-021

489401-062

830.73003

Density/Relative 

Density/Bulk Density 

(Specific Gravity) 

45 lb/ft3 33.9 lb/ft3

1

 Study supporting Phyllom grubGONE! G, EPA File Symbol 88347-E 

2

 Study supporting Phyllom beetleGONE!TM biological insecticide, EPA File Symbol 88347-G 3

 According to 40 C.F.R. § 158.2120, these data are only required for the technical grade of the active ingredient. Since Phyllom, LLC, 

included this information with its application for Phyllom grubGONE! G and/or Phyllom beetleGONE!TM biological insecticide, it is 

summarized appropriately in this table. 
Bacillus thuringiensis subspecies galleriae strain SDS-502 Page 36 of 42 

Biopesticides Registration Action Document 

TABLE 5. Toxicology Data Requirements for the Technical Grade of the Active Ingredient (TGAI), Bacillus thuringiensis subspecies 

galleriae strain SDS-502, and Its Manufacturing-Use Pesticide Product (MP), Phyllom SDS-502 MP (40 C.F.R. § 158.2140)

Harmonized 

Guideline 

Number 

Data Requirement

Results 

MRID No. 

TGAI MP 

Tier I

885.3050 Acute Oral 

Toxicity/Pathogenicity 

Not toxic, infective, and/or 

pathogenic to rats when 

administered by oral gavage in 

a single dose of 2.4 x 108

 cfu 

per rat. 

Classification: Acceptable 

N/A 

485532-08 

485532-11 

489401-08 

885.3150 Acute Pulmonary 

Toxicity/Pathogenicity 

No conclusions can be made 

regarding infectivity, 

pathogenicity or toxicity based 

on the study results. Attributing 

lethal effects to dosing was not 

followed up with alternate 

dosing methods. Replaced with 

MRID No. 489731-01 (acute 

inhalation toxicity study 

conducted with the MP, see 

below). 

Classification: Unacceptable

485532-09 

485532-11 

489401-08 

885.3200 Acute Injection 

Toxicity/Pathogenicity 

Not toxic, infective, and/or 

pathogenic to rats when 

administered intraperitoneally 

in a single dose of 2.02 x 107

cfu per rat. 

Classification: Acceptable

485532-10 

485532-11 

489401-08 

885.3400 Hypersensitivity 

Incidents 

The applicant reported that no hypersensitivity incidents, including immediate-type 

or delayed-type reactions of humans and domestic animals, occurred during 

research, development, or testing of the TGAI or MP. Any future hypersensitivity 

incidents must be reported to the EPA (refer to test note #3 of 40 C.F.R. § 

158.2140(d)). 

485532-12 

885.3500 Cell Culture 

Not required because Bacillus 

thuringiensis subspecies 

galleriae strain SDS-502 is not 

a virus (refer to test note #4 of 

40 C.F.R. § 158.2140(d)). 

N/A 485532-13 

870.1100 Acute Oral Toxicity N/A 

Testing waived based on the applicant’s 

scientific rationale, which cited to the results of 

MRID No. 485532-08 (acute oral 

toxicity/pathogenicity study conducted with the 

TGAI, see above in this table), and because this 

formulation contains inert ingredients that are 

not expected to be of toxicological concern 

through the oral route of exposure (refer to test 

note #5 of 40 C.F.R. § 158.2140(d)). 

Classification: Acceptable 

TOXICITY CATEGORY III

485532-14 
Bacillus thuringiensis subspecies galleriae strain SDS-502 Page 37 of 42 

Biopesticides Registration Action Document 

TABLE 5. Toxicology Data Requirements for the Technical Grade of the Active Ingredient (TGAI), Bacillus thuringiensis subspecies 

galleriae strain SDS-502, and Its Manufacturing-Use Pesticide Product (MP), Phyllom SDS-502 MP (40 C.F.R. § 158.2140)

Harmonized 

Guideline 

Number 

Data Requirement

Results 

MRID No. 

TGAI MP 

870.1200 Acute Dermal Toxicity N/A 

Testing waived based on the results of MRID 

No. 485532-18 (acute dermal toxicity and 

pathology study conducted with this MP, see 

below in this table), and because this 

formulation contains inert ingredients that are 

not expected to be of toxicological concern 

through the dermal route of exposure (refer to 

test note #5 of 40 C.F.R. § 158.2140(d)). 

Classification: Acceptable 

TOXICITY CATEGORY III

485532-15 

870.1300 Acute Inhalation 

Toxicity 

Inhalation LC50 > 4.30 mg/L 

Classification: Acceptable 

TOXICITY CATEGORY IV

489731-01 

870.2400 Acute Eye Irritation 

N/A

Phyllom SDS-502 MP was mildly-irritating to 

the eyes of rabbits. 

Classification: Acceptable 

TOXICITY CATEGORY III

485532-17 

870.2500 Primary Dermal 

Irritation 

Phyllom SDS-502 MP was essentially nonirritating to the skin of rabbits. All animals were 

free of very slight erythema or other skin-related 

findings by day 7. 

Classification: Acceptable 

TOXICITY CATEGORY III

485532-18 

Tiers II and III

Not required for Bacillus thuringiensis subspecies galleriae strain SDS-502 based on the lack of acute toxicity/pathogenicity attributed to the 

bacterium in the Tier I studies. 
Bacillus thuringiensis subspecies galleriae strain SDS-502 Page 38 of 42 

Biopesticides Registration Action Document 

TABLE 6. Toxicology Data Requirements for the End-Use Pesticide Products (EPs), Phyllom grubGONE! G and Phyllom 

beetleGONE!TM biological insecticide (40 C.F.R. § 158.2140)

Harmonized 

Guideline 

Number 

Data Requirement 

Results MRID No. or 

Other 

Phyllom grubGONE! G Reference Phyllom beetleGONE!TM biological 

insecticide 

885.3050 Acute Oral 

Toxicity/Pathogenicity 

885.3150 N/A N/A Acute Pulmonary 

Toxicity/Pathogenicity 

885.3200 Acute Injection 

Toxicity/Pathogenicity 

885.3400 Hypersensitivity 

Incidents 

The applicant reported than no hypersensitivity incidents, including immediatetype or delayed-type reactions of humans and domestic animals, occurred during 

research, development, or testing of the EPs. Any future hypersensitivity incidents 

must be reported to the EPA (refer to test note #3 of 40 C.F.R. § 158.2140(d)). 

485698-081

489731-022

885.3500 Cell Culture N/A N/A 

870.1100 Acute Oral Toxicity 

Testing waived based on the applicant’s scientific rationale, which cited to the 

results of MRID No. 485532-08 (acute oral toxicity/pathogenicity study conducted 

with the TGAI, see Table 5), and because this formulation contains inert 

ingredients that are not expected to be of toxicological concern through the oral 

route of exposure (refer to test note #5 of 40 C.F.R. § 158.2140(d)). 

Classification: Acceptable 

TOXICITY CATEGORY III

485698-091

489731-032

490940-011,2

Rose (2013b)2 

870.1200 Acute Dermal 

Toxicity 

Testing waived based on the results of 

MRID No. 485698-13 (acute dermal 

toxicity and pathology study conducted 

with this EP, see below in this table). 

Because the EPA classified the 

product-specific acute eye irritation 

study done with this EP as Toxicity 

Category II, a Toxicity Category of no 

higher than III is to be used for labeling 

of dermal hazards. 

Classification: Acceptable 

TOXICITY CATEGORY III 

Testing waived based on the applicant’s 

scientific rationale, which cited to the 

results of MRID No. 485532-18 (acute 

dermal toxicity and pathology study 

conducted with the MP, see Table 5), 

and because this formulation contains 

inert ingredients that are not expected to 

be of toxicological concern through the 

dermal route of exposure (refer to test 

note #5 of 40 C.F.R. § 158.2140(d)). 

Classification: Acceptable 

TOXICITY CATEGORY III

485698-101

489731-042

490940-011,2

Rose (2013b)2

870.1300 Acute Inhalation 

Toxicity 

Testing waived based on the 

applicant’s scientific rationale, which 

cited to the results of MRID No. 

489731-01 (acute inhalation toxicity 

study conducted with the MP, see 

Table 5). Because the EPA classified 

the product-specific acute eye irritation 

study done with this EP as Toxicity 

Category II, a Toxicity Category of no 

higher than III is to be used for labeling 

of inhalation hazards. 

Classification: Acceptable 

TOXICITY CATEGORY III 

Testing waived based on the applicant’s 

scientific rationale, which cited to the 

results of MRID No. 489731-01 (acute 

inhalation toxicity study conducted with 

the MP, see Table 5), and because this 

formulation contains inert ingredients 

that are not expected to be of 

toxicological concern through the 

inhalation route of exposure (refer to test 

note #5 of 40 C.F.R. § 158.2140(d)). 

Classification: Acceptable 

TOXICITY CATEGORY IV

489731-052

489731-081

490940-011,2

Rose (2013b)2
Bacillus thuringiensis subspecies galleriae strain SDS-502 Page 39 of 42 

Biopesticides Registration Action Document 

TABLE 6. Toxicology Data Requirements for the End-Use Pesticide Products (EPs), Phyllom grubGONE! G and Phyllom 

beetleGONE!TM biological insecticide (40 C.F.R. § 158.2140)

Harmonized 

Guideline 

Number 

Data Requirement 

Results MRID No. or 

Other 

Phyllom grubGONE! G Reference Phyllom beetleGONE!TM biological 

insecticide 

870.2400 Acute Eye Irritation 

Phyllom grubGONE! G was severely 

irritating to the eyes of rabbits. 

Classification: Acceptable 

TOXICITY CATEGORY II 

Testing waived based on the applicant’s 

scientific rationale, which cited to the 

results of MRID No. 485532-17 (acute 

eye irritation study conducted with the 

MP, see Table 5), and because this 

formulation contains inert ingredients 

that are not expected to be of 

toxicological concern through this route 

of exposure (refer to test note #5 of 40 

C.F.R. § 158.2140(d)). 

Classification: Acceptable 

TOXICITY CATEGORY III 

485698-121

489731-062 

490940-012

Rose (2013b)2

870.2500 Primary Dermal 

Irritation 

Phyllom grubGONE! G was essentially 

non-irritating to the skin of rabbits. All 

animals were free of very slight to 

moderate erythema or other skinrelated findings by day 7. 

Classification: Acceptable 

TOXICITY CATEGORY III 

Testing waived based on the applicant’s 

scientific rationale, which cited to the 

results of MRID No. 485532-18 (acute 

dermal toxicity and pathology study 

conducted with the MP, see Table 5), 

and because this formulation contains 

inert ingredients that are not expected to 

be of toxicological concern through this 

route of exposure (refer to test note #5 of 

40 C.F.R. § 158.2140(d)). 

Classification: Acceptable 

TOXICITY CATEGORY III

485698-131

489731-072

490940-012

Rose (2013b)2

1

 Study supporting Phyllom grubGONE! G, EPA File Symbol 88347-E 

2

 Study supporting Phyllom beetleGONE!TM biological insecticide, EPA File Symbol 88347-G
Bacillus thuringiensis subspecies galleriae strain SDS-502 Page 40 of 42 

Biopesticides Registration Action Document 

TABLE 7. Nontarget Organism Toxicity and Environmental Fate Data Requirements for the Technical Grade of the Active 

Ingredient (TGAI), Bacillus thuringiensis subspecies galleriae strain SDS-502 (40 C.F.R. § 158.2150)

Harmonized Guideline 

Number Data Requirement Results MRID No. or Other 

Reference 

Tier I

885.4050 Avian Oral Toxicity 

The maximum daily dose for Bacillus 

thuringiensis subspecies galleriae strain SDS-502 

was determined as 3.0 x 1011 cfu/kg body weight. 

Classification: Acceptable 

485532-19 

489401-07 

Rose (2013b) 

885.4100 Avian Inhalation 

Toxicity/Pathogenicity 

Scientific rationale was sufficient to satisfy the 

data requirement. Bacillus thuringiensis

subspecies galleriae strain SDS-502 is not 

considered toxic or pathogenic to birds. 

Classification: Acceptable

485532-20 

885.4150 Wild Mammal 

Toxicity/Pathogenicity 

Tests required by 40 C.F.R. § 158.2140 are 

adequate and appropriate for assessment of 

hazards to wild mammals. The oral LD50 is 

greater than 2.4 x 108

 cfu Bacillus thuringiensis

subspecies galleriae strain SDS-502 per rat. 

Bacillus thuringiensis subspecies galleriae strain 

SDS-502 was not infective, pathogenic or toxic to 

laboratory rats. 

Classification: Acceptable 

485532-08 

485532-11 

485532-21 

489401-08 

885.4200 Freshwater Fish 

Toxicity/Pathogenicity 

Scientific rationale was sufficient to satisfy the 

data requirement. Bacillus thuringiensis

subspecies galleriae strain SDS-502 is not 

considered toxic or pathogenic to fish. 

Classification: Acceptable 

485532-22 

885.4240 Freshwater Invertebrate 

Toxicity/Pathogenicity 

A 21-day study shows that the EC50 for survival, 

reproduction, and growth of Daphnia magna is 

greater than 100 mg/L. The NOEC for survival is 

100 mg/L (2.5 x 107

 cfu/mL), and the NOEC for 

reproduction and growth is 50 mg/L (8.9 x 106

cfu/mL). 

Classification: Acceptable 

485532-04 

485532-23 

489401-07 

Rose (2013b) 

885.4280 Estuarine/Marine Fish and 

Invertebrate Testing 

Scientific rationale was sufficient to satisfy the 

data requirement. Bacillus thuringiensis

subspecies galleriae strain SDS-502 is not 

considered toxic or pathogenic to estuarine or 

marine organisms. 

Classification: Acceptable 

485532-24 

885.4300 Nontarget Plant Testing 

Scientific rationale was sufficient to determine 

that adverse effects are not expected in plants 

(terrestrial and aquatic) as a result of exposures to 

Bacillus thuringiensis subspecies galleriae strain 

SDS-502. 

Classification: Acceptable 

485532-25 

885.4340 Nontarget Insect Testing 

The 9-day LC50 and NOEC was greater than 

1,700 ppm for adult ladybird beetles 

(Hippodamia convergens) exposed to artificial 

diets amended with Bacillus thuringiensis

subspecies galleriae strain SDS-502 Cry8Da 

protein. Maximum hazard doses were confirmed. 

Classification: Acceptable 

485532-04 

485532-26 

489401-07 

Rose (2013b) 
Bacillus thuringiensis subspecies galleriae strain SDS-502 Page 41 of 42 

Biopesticides Registration Action Document 

TABLE 7. Nontarget Organism Toxicity and Environmental Fate Data Requirements for the Technical Grade of the Active 

Ingredient (TGAI), Bacillus thuringiensis subspecies galleriae strain SDS-502 (40 C.F.R. § 158.2150)

Harmonized Guideline 

Number Data Requirement Results MRID No. or Other Reference 

885.4340 Nontarget Insect Testing 

The 96-hour LC50 for Bacillus thuringiensis

subspecies galleriae strain SDS-502 was greater 

than 500 μg Cry8Da protein/mL diet for first 

instars of Colorado potato beetle (Leptinotarsa 

decemlineata). The maximum hazard dose could 

not be confirmed. 

Classification: Supplemental 

485532-28 

489401-07 

Rose (2013b) 

885.4340 Nontarget Insect Testing 

No mortalities were observed in four species of 

adult parasitic wasps (Tetrastichus planipennisi, 

Oobius agrili, Spathius agrili, Atanycolus 

cappaerti, Order Hymenoptera), whereas 52% 

mortality was noted for the adult emerald ash 

borer (Agrilus planipennis) when exposed to 0.4 

μg Cry8Da/μL honey diet. Maximum hazard 

doses could not be confirmed. 

Classification: Supplemental

487168-03 

489401-07 

Rose (2013b) 

885.4340 Nontarget Insect Testing 

Data and information provided on three 

lepidopteran insect species (Bombyx 

mori, Plutella xylostella, and Spodoptera litura) 

are useful for demonstrating potential spectra of 

insecticidal activity. The test duration (2 to 5 

days) may have been of insufficient length for 

insect species that showed no mortality (Bombyx 

mori and Spodoptera litura). Maximum hazard 

doses could not be confirmed. 

Classification: Supplemental

485532-27 

489401-07 

Rose (2013b) 

885.4340 Nontarget Insect Testing 

No adverse effects were observed when larvae of 

Southern corn rootworm (Diabrotica 

undecimpunctata howardi) were exposed to 

reported concentrations of purified Cry8Da 

protein in artificial diets. There were no 

quantitative data or information to confirm the 

concentrations of the test material and reported 

results. Maximum hazard doses could not be 

confirmed. 

Classification: Unacceptable 

485532-29 

489401-07 

Rose (2013b) 

885.4380 Honey Bee Testing 

The 20-day NOEC for Bacillus thuringiensis

subspecies galleriae strain SDS-502 was 500 ng 

Cry8Da protein/honeybee larval cell. There is 

uncertainty in the amount of Cry8Da protein that 

might remain in the environment after 

applications of the microbial pesticide. The study 

provides useful information for a honeybee larval 

toxicity profile for the Cry8Da protein at the 

screening level. The maximum hazard dose could 

not be confirmed. 

Classification: Supplemental

485532-30 

489401-07 

Rose (2013b) 

Tiers II, III, and IV 

Not required for Bacillus thuringiensis subspecies galleriae strain SDS-502 based on the acceptability of the scientific rationale and studies 

provided for Tier I. 
Bacillus thuringiensis subspecies galleriae strain SDS-502 Page 42 of 42 

Biopesticides Registration Action Document 

APPENDIX B. PESTICIDE PRODUCTS 

EPA File 

Symbol 

Registration 

Name 

Percentage 

Active 

Ingredient 

Formulation 

Type 

Use Site(s) Method(s) of 

Application 

Application Rate(s) Target Pest 

88347-R Phyllom SDS502 MP 90.0% Technical N/A 

88347-E Phyllom 

grubGONE! G 9.0% End Use – 

Granule 

Turf and 

ornamentals 

Calibrated 

granular 

equipment 

115–150 pounds per 

acre 

White grubs of certain 

beetles 

(e.g., Japanese beetle) 

88347-G 

Phyllom 

beetleGONE! 

biological 

insecticide 

76.5% 

End Use – 

Water 

Dispersible 

Powder 

Ornamentals, 

select crops for 

food and animal 

feed uses, and 

poultry premises 

Ground or aerial 

application 

equipment 

Variable 

(see draft label in 

docket for specifics) 

Certain beetle pests, 

particularly those in the 

Families Buprestidae, 

Scarabaeidae, and 

Curculionidae