## Proposed Registration Decision for the New Active Ingredient 

## Bacillus amyloliquefaciens strain PTA-4838

Date:Page 2 of 12 

### 1. Summary

This document announces that the Environmenta l Protection Agency (EPA) has completed its

initial evaluation of the proposed new microbial pest icide active ingredient Bacillus amyloliquefaciens strain PTA-4838 (hereafter, B. amyloliquefaciens PTA-4838) and has concluded that it meets the regulatory and sa fety standards under the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA) and the Federal Food, Drug and Cosmetics Act (FFDCA). The Agency is seeking public comment on its proposed decision.

LidoChem, Inc. has submitted applications to register the new active ingredient, B. amyloliquefaciens PTA-4838 for use as a manufacturing-us e product (MP) and as an end-use product (EP) for biological seed treatment that provides earl y protection against selected parasitic nematodes. Varnimo Technical and Varnimo ® ST each contain 73.4% active ingredient

at a minimum of 5 x 10 11 cfu/g. Lidochem Inc., has also submitted a petition for an exemption from the requirement of a tolerance for B. amyloliquefaciens PTA-4838 on all food and feed

crops.

EPA has previously regist ered other strains of B. amyloliquefaciens (strains D747 and FZB24) which were formerly classified as B. subtilis var. amyloliquefaciens (Priest et al., 1987; USEPA, 2010; USEPA, 2011).

Bacillus amyloliquefaciens is a gram-positive non-pathogenic bacterium which is commonly found in the air, water, soil, and on plants. B. amyloliquefaciens is used to produce proteolytic enzymes for laundry detergents, is used in chic ken broiler feed as a probiotic, and produces chitinase, protease, and lipases which suppress f ungi and nematodes. In addition to the enzymes phytase, chitinase, lipase and protease , B. amyloliquefaciens PTA-4838 also produces several secondary metabolites incl uding antifungal lipoproteins.

After reviewing submitted and publically availa ble data and information, EPA has concluded

that there is a reasonable certa inty of no harm from residues of this new active ingredient and

that it will not cause any unreasonable adverse effect s to human health or the environment. Therefore, the Agency is proposing to register the microbial pesticide manufacturing-use product containing the new active ingred ient under FIFRA section 3(c)(5 ) and establish an exemption from the requirement of a tolerance.



### 2. Background

On September 24, 2014, the U.S. Environmental Prot ection Agency (EPA) received applications for registration for the new microbi al pesticide active ingredient B. amyloliquefaciens strain PTA-4838 from LidoChem, Inc. as well as a petiti on for an exemption from the requirement of a

tolerance.Page 3 of 12 

### 3. Evaluation

In evaluating a pesticide registra tion application, the EPA assesses a wide variety of studies and

information to determine the likelihood of advers e effects (i.e., risk) from exposures associated with the proposed use of the product. Risk a ssessments are developed to evaluate how the compound might affect a wide range of non-target organisms, incl uding humans and terrestrial and aquatic wildlife (p lants and animals).

Based on these assessments, the EPA evaluate s and approves conditions for each pesticide product to ensure that permitted uses and safe ty measures are appropr iate to mitigate any potential risk.

The human health and environmental risk assessm ents supporting this de cision can be found in the regulatory docket (Docket Number EPA–HQ–OPP–2015–0417).



### 3.1 Assessment of Risk to Human Health

In order to assess a microbial pesticide’s risk to human health, the EPA initially requires a wide range of studies, including Tier I acute toxicity/pathogenicity (o ral, pulmonary, and injection) data, cell culture data, reports of hypersensitivity incidents, acute toxicity (oral, dermal, and inhalation) data, and irritation (dermal and eye) data. Tier II and III testing (e.g., subchronic toxicity/pathogenicity) is triggered only when there is indication, usually through lower tier testing, that a microbial pesticide has unusual toxicological characteri stics, such as infectivity or being suspected as or known to be a carcinogen.

3.1.1 Toxicity/Pathogenicity Profile

Toxicity and Pathogenicity

B. amyloliquefaciens is a gram-positive non-pathogenic ba cterium which is ubiquitous in the environment and commonly found in the air, water, soil, and on plants. B. amyloliquefaciens produces chitinase, protease, and lipases whic h suppress fungi and nematodes and has been reported as having plant grow th regulator activity.

Acute oral, pulmonary, and injection toxicity/pathogenicity testing of B. amyloliquefaciens strain

PTA-4838 has shown that it is not toxic or pathogenic. As no adve rse effects have been observed

in the available data for B. amyloliquefaciens strain PTA-4838, the Agency has not identified any points of departure for conducting a quantitative risk assessment of B. amyloliquefaciens PTA4838 . Consequently, the Agency has c onducted a qualitative assessment.

Related Bacillus subtilis species are known to cause spoilage and have been identified as causing

foodborne illness outbreaks in rare circum stances. Additionally, certain strains of B. amyloliquefaciens that produce the toxin amylosin have been associated with reported infections when found, together with other pathogens in indoor dust in water damaged buildings.Page 4 of 12 However, no reported foodborne illne sses have been associated with B. amyloliquefaciens or B. amyloliquefaciens PTA-4838 and the production of amylosin has not been reported with the B. amyloliquefaciens PTA-4838 strain. Furthermore, as mentioned above, the acute oral, pulmonary and injection toxicity pathogenicity studies show no signs of toxicity or pathogenicity

for this strain. Thus , B. amyloliquefaciens PTA-4838 is not considered a risk for infection.

Acute Toxicity

As mentioned above, acute oral, pulmonary, and injection toxicity/pat hogenicity testing of

Varnimo Technical has shown that it is not toxic/pathogenic. These finding support submitted waivers for the acute systemic toxicity data requirements for technical grade B. amyloliquefaciens PTA-4838 . Based on the microbial pesticides toxicology data requirements 158.2140 (c) and (d) footnote 5, the 870 series acute studies may be waived if the toxicity/pathogenicity are acceptable and the added inerts can be shown as not likely to pose any significant human health risks which applies in th is case. Further the Agency does not anticipate a different irritation profile fo r the technical grade material compared to the end use product summarized below since the inert ingredients are most likely to drive ir ritation potential of products containing B. amyloliquefaciens PTA-4838 . Therefore, eye irritation and dermal irritation data requirements for th e technical grade material have been waived and the Agency will rely upon the acute testing for the WSP product for labeling purposes.

Acute toxicity data for the end use product resulted in Toxicity Category IV for oral toxicity and eye irritation and Toxicity Category III for derm al toxicity, inhalation toxicity, and dermal

irritation.

3.1.2 Aggregate Exposure

In examining aggregate exposure, FFDCA sec tion 408 directs EPA to consider available information concerning exposures from the pe sticide residue in food and all other nonoccupational exposures, includi ng drinking water from ground water or surface water and exposure through pesticide use in gardens, lawn s, or buildings (reside ntial and other indoor uses).

A. Dietary Exposure

1. Food Exposure : B. amyloliquefaciens is ubiquitous in the environmen t, especially in soils and agricultural environments, so di etary exposure to background leve ls of the naturally occurring microbe are already occurring. B. amyloliquefaciens are considered GRAS food additives and the FDA has estimated that dietary exposure of B. subtilis and B. amyloliquefaciens by the U.S. population is 200 mg/day. Dietary e xposure via crop residues from pesticidal uses will be much lower based on maximum app lication rates. Further, B. amyloliquefaciens PTA-4848 has been found to be not toxic or pathoge nic based on guideline toxicity te sting and is not expected to

cause adverse health effects.

2. Drinking water exposure : B. amyloliquefaciens is naturally present in soils. Therefore, B. amyloliquefaciens may occur in surface water and possi bly groundwater. According to thePage 5 of 12 World Health Organization, Bacillus species are often detected in drinking water even after going through acceptable water treatment processes, mostly because the spores are resistant to municipal water treatment measures. Should this microbial pesticide be present, no adverse effects are expected from exposure to B. amyloliquefaciens through drinking water since it has been found to be not toxic or pathogenic based on guideline toxicity tes ting and is not expected

to cause adverse health effects.

B. Other Non-Occupational Exposure

No indoor residential, school or daycare uses currently appear on the label. Non-dietary exposure as a result of the agricultural uses could occur where children are present, but the health risk is expected to be negligible since B. amyloliquefaciens PTA-4838 has been found to be not toxic or pathogenic based on guideline toxici ty testing, and the fact that B. amyloliquefaciens is ubiquitous in the environment and populations have been previously exposed to the microbe over time with no reports of infection or other adverse effect.

3.1.3 Determination of Safety for U.S. Population, Infants and Children

A. U.S. Population: Although there is likely to be diet ary and non-occupational exposure to B. amyloliquefaciens PTA-4838 , the Agency concludes that there is reasonable certainty that no harm will result to the U.S. population, includi ng infants and children, from aggregate exposure

to residues of B. amyloliquefaciens PTA-4838 because of the lack of any toxicity, infectivity, and pathogenicity of this microbe. This includes a ll anticipated dietary exposures and all other exposures for which there is reliable information.

B. Infants and Children : FFDCA section 408(b)(2)(C) provides that the EPA shall apply an additional tenfold (10X) margin of safety for infa nts and children in the ca se of threshold effects to account for prenatal and postnat al toxicity and the completene ss of the database on toxicity and exposure, unless the EPA determines based on reli able data that a different margin of safety

will be safe for infants and children. This additiona l 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 or uses a different addi tional safety factor when reliable data available to the EPA support the choice of a different factor.

As discussed above, EPA has concluded that B. amyloliquefaciens PTA-4838 is not toxic, pathogenic, or infective to mammals, includ ing infants and children. Because there are no

threshold levels of concern to in fants, children, and adults when B. amyloliquefaciens PTA-4838 is used according to label di rections and good agricultural pr actices, EPA concludes that no additional margin of safety is necessa ry to protect infants and children.

3.1.4 Cumulative Effects from Substances wi th a Common Mechanism of Toxicity

EPA has not determined that B. amyloliquefaciens strain PTA-4838 shares a common mechanism of toxicity with any other substanc es. For information regarding EPA’s efforts to

determine which chemicals have a common mech anism of toxicity and to evaluate thePage 6 of 12 cumulative effects of such chemicals, see EPA’s website at http://www.epa.gov/pesticides/cumulative

.

3.1.5 Occupational Exposure

Because of a lack of mammalian toxicity, the risk from occupational exposure is minimal. No additional exposure data or changes in the proposedlabels to restrict exposure are recommended

at this time.

3.2 Assessment of Ecological Risk

In order to assess a microbial pesticide’s risk to the environment, the EPA initially requires a wide range of studies, including Ti er I testing done on the follow ing non-target organisms: birds (oral and inhalation), mammals, fr eshwater fish and invertebrate s, estuarine/marine fish and invertebrates, plants, insects, and honeybees. Higher tier testi ng (II, III, and IV) generally encompasses definitive hazard determinations a nd longer term greenhouse or field testing and is implemented only when unacceptable effects are seen at the Tier I screening level.



### 3.2.1 Terrestrial Animals and Plants

Birds and Mammals Birds and mammals may be exposed to applications of B. amyloliquefaciens PTA-4838 primarily through ingestion of seeds. The Agency revi ewed the available ecotoxicity data and has

determined that there is no evidence of toxicity to birds or mammals.

Based on two submitted avian oral studies, B. amyloliquefaciens PTA-4838 is not toxic or pathogenic to Northern bobwhite ( Colinus virginianus ) dosed at 9.46 x 10 9 cfu/bird/day, with a total 5-day dose of 4.73 x 10 10 cfu/bird. For seed treatment us es, exposure by direct consumption of treated seed is expected to be below the levels tested in the t oxicity studies, since a bird would need to consume greater than 1000g of seed per day to achieve the same level of exposure as the

birds in the studies described a bove. Therefore, based on the pr oposed application rate and lack

of adverse effects observe d in birds exposed to B. amyloliquefaciens strain PTA-4838 at the levels tested, risk to non-target birds resulting from the proposed registration is not expected.

Some wild mammals may be exposed to B. amyloliquefaciens strain PTA-4838 in treated areas; however, adverse effects were not observed in the mammalian studi es as described above, which

were tested at maximum hazard dose levels. Theref ore, risk to wild mammals is not expected from the proposed registration of B. amyloliquefaciens strain PTA-4838.

Nontarget Insects and Honey Bees B. amyloliquefaciens is known to produce secondary metabolites and/or enzymes that may adversely affect insects, and seve ral recent reports in the literature indicate the potential for use

of this bacterium or its biosurfactants in in sect control (Gadhave a nd Gange, 2016; Khedher et al., 2015; Li et al., 2015; Yun et al. 2013). On the other hand, B. amyloliquefaciens has been isolated from the gut of certain insects (see USEPA, 2010).Page 7 of 12 Green lacewing ( Chrysoperla rufilabris ) larvae testing of B. amyloliquefaciens strain PTA-4838 did not show toxic/pathogenic effects at the maximum hazard dose. Honey bee ( Apis mellifera ) testing of B. amyloliquefaciens strain PTA-4838 indicated that it is not toxic to honey bees at a rate determined to be equivalent to approxi mately 2,000X the maximum application field rate based on assumptions oforfoliar a pplication when administered orally (EPA). Adult ladybird beetles ( Hippodamia convergens ) and adult parasitic wasp ( Aphidius coleman ) toxicity studies

were also submitted on B. amyloliquefaciens strain PTA-4838; however the results were

inconclusive and could not be relied on for us e in a quantitative risk assessment due to shortcomings in study design and execution. Theref ore, risks to non-target insects could not be

determined for these and related insect species without some uncertainty.

In order to limit exposures to non-target insects, th e registrant has agreed to limit applications to seed treatments. No foliar applic ations will be registered at this time. Exposure to non-target insects is expected to be limited to contact with soil directly exposed to tr eated seed. Within soil, exposure is expected to be spatially limited, since B. amyloliquefaciens strain PTA-4838 is expected to primarily inhab it plant roots once applied. B. amyloliquefaciens strain PTA-4838 may persist with formation of endos pores; however, it is noted that B. amyloliquefaciens is a common inhabitant of soil and non-target insects like ly are already exposed at some level to this bacterium. Therefore, based on the available da ta and the limited exposure to non-target insects expected from seed treatment applications, adve rse effects to honeybees and non-target insects as a result of the proposed seed treatment applications of B. amyloliquefaciens PTA-4838 are not anticipated.

Nontarget Plants
B. amyloliquefaciens grows in association with plants (Alvarez et al., 2011) and is a plant growth-promoting bacterium (Chen et al., 2007). B. amyloliquefaciens is not a known plant pathogen and adverse effects to non-target plants have not been documented. Therefore, adverse effects are not anticipated from the propos ed registration of th e products containing B. amyloliquefaciens PTA-4838.

3.2.2. Aquatic Animals and Plants

Freshwater Fish and Invertebrates B. amyloliquefaciens PTA-4838 produces a biosurfactant (s urfactin), chitinase and other secondary metabolites (MRID No. 49474102). Surfactan ts are reported to be toxic to fish and invertebrates (Abel, 1974; Abel and Skidmore, 1975) and chitinase can be toxic to invertebrates containing chitin as a structural component.

B. amyloliquefaciens PTA-4838 was tested on Oncorhynchus mykiss (rainbow trout) at 1 x 10 6

cfu/mL and 1 x 10 7 cfu/mL and had an adverse effect on survival (100% mortality within 15 days of testing) at 10 7 cfu/mL (0% mortality was observed at 1 x 10 6 cfu/mL). Results also showed an adverse effect on growth (weight and length) at both concentrations, with greater

effects observed at 10 7 cfu/mL. While there is some con cern with the accuracy of growth measurements, adverse effects in this study were dose dependent with re latively low levels of effects at the lower concentration (at 10 6 cfu/mL reductions in growth compared to the control ranged from 8% - 17%). Daphnia magna freshwater invert ebrate testing of B. amyloliquefaciensPage 8 of 12 PTA-4838 indicated no significant e ffect on mobility (indicator of mortality), but showed a potential toxic/pathogenic e ffect on reproduction at 1 x 10 5 cfu/mL.

An estimated environmental concentration for wa ter following aerial applications proposed with foliar uses, accounting for spray drif t, was calculated to be 3.8 x 10 2 cfu/mL, which is approximately 1000X below the lowest level at which any effect was observed. Exposure would be expected to be much lower with the currently proposed seed treatment uses.

Since the potential for exposure falls many orders of magnitude below the 10 5 cfu/mL from the Daphnia study described above, and the 10 6 and 10 7 cfu/mL in the rainbow trout study above, adverse effects to aquatic animals in freshwater systems are not expected.

Marine/Estuarine Fish and Invertebrates Grass shrimp ( Paleomonetes vulgaris ) testing of B. amyloliquefaciens PTA-4938 at

concentrations of 10 5 cfu/g diet or 10 6 cfu/g diet indicated no signi ficant difference in mortality and in the weight/length of the shrimp among di fferent test groups under the conditions tested

and an EC 50 greater than 10 6 cfu/g.

Inland silverside ( Menidia beryllina ) testing of B. amyloliquefaciens PTA-4938 at concentrations

of 10 6 cfu/mL or 10 7 cfu/mL in the test water demonstr ated a mortality ra te of 40% at 10 7
cfu/mL, but no significant mortality at 10 6 cfu/mL. Based on mortality observations, the LC 50 was determined to be greater than 10 6 cfu/mL. There was no statisti cally significant difference in the weight or length of the silverside am ong different test groups when tested at10 6 cfu/mL or

10 7 cfu/mL. Some uncertainties ar e associated with the growth measurements, since the study indicated unusual results (e.g., fish do not nor mally shrink in length, suggesting a potential measurement error); however, the mortality observations are considered reliable.

Similar to a case with th e non-target organisms in freshwater environments, B. amyloliquefaciens PTA-4838 exposure is expected to be > 1,000X be low the levels at which organisms were exposed in the above studies. Exposure in aquatic environments with the proposed seed treatment use is expected to be even lower. Th erefore, adverse effects to aquatic organisms in

marine and estuarine environm ents are not expected.

3.2.3 Ecological Risk & Federally Listed Threate ned and Endangered Species Conclusions

Based on available information, EPA has determined that no adverse effects are anticipated for birds, mammals, fish, aquatic invertebrates, non-target insects, and plants exposed to B. amyloliquefaciens PTA-4838 as a result of the proposed labeled applications as a seed treatment where foliar applications are pr ecluded. Therefore, a “No Effect ” determination is made for

direct and indirect effects to li sted species of these taxa and th eir designated critical habitats resulting from the proposed registration of B. amyloliquefaciens PTA-4838

.



### 4. Alternatives

The use of this microbial insecticide could re duce the use of conventional insecticides in commercial agriculture and on resi dential lawns and gardens.Page 9 of 12 

### 5. Benefits and Public Comments

 Biopesticides are pesticides derived from su ch natural materials as animals, plants, bacteria, and certain minerals. Microbial pestic ides, a class of biopest icides, consist of a microorganism (e.g., bacterium, fungus, virus, or protozoan) as the ac tive ingredient and Can offer another tool for pest management in areas where pesticide resistance, niche markets, environmental concerns, and orga nic preference limit the use of conventional pesticides.

 Can greatly decrease the use of conventiona l pesticides while crop yields remain high, when used as a component of integrated pest management programs.

Like other microbial pesticides, B. amyloliquefaciens PTA-4838 aligns w ith the potential

benefits above.

In the Federal Register of July 20, 2015 (80 FR 42802), the EPA announced receipt of the application to register a pest icide product containing a new activ e ingredient for manufacturing use. The EPA opened a 30-day public comment period pursuant to the provisions of FIFRA section 3(c)(4). Following this publication, the Agency received no public comments.

Because LidoChem Inc.’s pesticide product applica tions involve a new active ingredient, as well as this active ingredient’s fi rst food uses, the EPA is opening a 15-day public comment period. The EPA is taking this action in accordance wi th a policy, first implemented in October 2009, designed to provide a more meaningful opportun ity for the public to participate in major registration actions.



### 6. Proposed Regulatory Decision

The B. amyloliquefaciens PTA-4838 database is comprised of studi es and information that meet the data requirements for and support the labeled uses of B. amyloliquefaciens PTA-4838. In considering the assessed risk to human health and the environment, the EPA concludes that B. amyloliquefaciens PTA-4838 meets the regulatory standard under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). Theref ore, the EPA is granting the unconditional registration of the B. amyloliquefaciens PTA-4838 pesticide products under FIFRA section 3(c)(5).

Additionally, EPA concludes that there is a reason able certainty that no harm will result to the U.S. population, including infants and childre n, from aggregate exposure to residues of B. amyloliquefaciens PTA-4838. The EPA does not expect di etary (food and drinking water) or other non-occupational risks from use of this microbi al pesticide as an acti ve ingredient in the pesticide product. Although exposure to B. amyloliquefaciens PTA-4838 through consumed food and drinking water is possible, the EPA anticip ates these types of e xposures based on supporting toxicological information will not result in adverse effectsPage 10 of 12 An exemption from the requirement of a tolerance for B. amyloliquefaciens PTA-4838 will be promulgated and one end-use and one manufacturi ng-use pesticide products will be registered.

Varnimo ® ST is for commercial seed treatment. Va rnimo Technical, a manufacturing-use product will also be registered.

The risk assessments supporting this decision can be found in the associated regulatory dockets (search for “EPA-HQ-OPP-2015-0417” at www.regulations.gov ).Page 11 of 12 

### 7. References

Abel, P.D. 1974. Toxicity of synthetic detergents to fish and aquatic inve rtebrates. Journal of Fish Biology, 6: 279-298.

Abel, P.D. and J.F. Skidmore. 1975. Toxic effects of an anionic detergent on the gills of rainbow trout. Water Research, 9: 59-65.

Alvarez, F., M. Castro, A. Princi pe, G. Borioli, S. Fisher, G. Fi scher, G. Mori and E. Jofre. 2011. The plant-associated Bacillus amyloliquefaciens strains MEP218 and ARP23 capable of producing the cyclic lipopipetides iturin or surfactin and fengycin are effective in biocontrol of

sclerotinia stem rot disease. Journa l of Applied Microbiology, 112: 159-174.

Apetroaie

‐ Constantin, C., et al. (2009). "Bacillus subtilis and B. moja vensis strains connected to food poisoning produce the heat stable toxin amyl osin." Journal of app lied microbiology 106(6):

1976-1985.

Chen, X.H., A. Koumoutsi, R. Scholz, A. Eisenreich, K. Schneider, I. Heinemeyer, B. Morgenstern, B. Voss, W.R. Hess, O. Reva, H. Junge, B. Voigt, P. R. Jungblut, J. Vater, R. Sussmuth, H. Liesegang, A. Strittmatter, G. Gottschalk and R. Borriss. 2007. Comparative analysis of the complete genome sequence of the plant growth-promoting bacterium Bacillus amyloliquefaciens FZB42. Nature Biotechnology, Advan ce Online Publication pages 7-14.

Gandhave, K.R. and A.C. Gange. 2016. Plant-associated Bacillus spp. Alter life-history traits of the specialist insect Brevicoryne brassicae L. Agricultural and Forest Entomology. 18:35-42.

https://microbewiki.kenyon.edu /index.php/Bacillus_subtilis

http://www.fda.gov/ohrms/dockets/98fr/042399a.txt

https://www.gpo.gov/fdsys/pkg/FR-2012-01-06/pdf/ 2011-33846.pdf, Federal Register/ Vol. 77, No. 4/ Friday, January 6, 2012/ Rules and Regulations

Khedher, S.B., H. Boukedi, O. Kilani-Feki, I. Chaib, A. Laarif, L. Abdelkefi-Mesrati and S.

Tounsi. 2015. Bacillus amyloliquefaciens AG1 biosurfactant: Putative receptor diversity and histopathological effects on Tuta absoluta midgut. Journal of Inve rtebrate Pathology, 132: 42-

47.

Li, H., M.A. Soares, m. S. Torres, M. Be rgen and J.F. White. 2015. Endophytic bacterium, Bacillus amyloliquefaciens , enhances ornamental hosta resist ance to disease and insect pests.

Journal of Plant Inte ractions, 10: 224-229.

Logan, N.A. and P. de Vos. 2009. Geneus I. Bacill us. Pp. 21-128 In: P.de Vos, G.M. Garrity, D. Jones, N.R. Krieg, W. Ludwig, F.A. Rainey, K.H. Schleifer, and W. Whitman (Eds.) Bergey’s Manual of Systematic Bacteriology, Volume 3, 2 nd Ed. Springer, New York.Page 12 of 12 Priest, F., Goodfellow, M., Shute, L., and Be rkeley, R. 1987. "Bacillus amyloliquefaciens sp. nom., nom. rev." Interna tional Journal of Systema tic Bacteriology. 37: 69-71. http://ijs.sgmjournals.or g/content/37/1/69.full.pdf

Talboys P.J., Owen D.W., Healey J. R., Withers P.J., and D.L. Jones. 2014. Auxin secretion by

Bacillus amyloliquefaciens FZB42 both stimulates root exudation and limits phosphorus uptake

in Triticum aestivum . BMC plant biology, 14: 51

US EPA. 2010. Bacillus subtilis Final Registration Review Decision Case 6012. Docket No. EPA-HQ-OPP-2007-1026. Washington, D.C.

US EPA. 2010. Bacillus subtilis Final Registration Review Decision Case 6012. Docket No. EPA-HQ-OPP-2007-1026.

US EPA. 2011. Memorandum from S. Borges (O PP/BPPD) to S. Cerrelli, Re: Environmental risk assessment for the FIFRA Section 3 registra tion of B. amyloliquefaciens strain D474 (EPA File Symbols 70051-RNI and -RNT); S ubmission No. 879171, Decision No. 437753, DP Barcode No. 382915. Dated October 3, 2011.

US EPA. 2016. Memorandum from M. Djuric kovic (OPP/BPPD) to M. Mendelsohn, Re: Review of 5 Batch Enumeration, Product Chemis try, Manufacturing Process, Storage Stability, Acute Toxicity Studies, and To lerance Exemption for Varnimo ® Technical/ST (EPA Reg. No. 760644-T) submitted by Lidochem Inc. Draft dated March 4, 2016.

Yun, D.C., S.I. Yang, Y.C. Kim, I.S. Kim and Y.H. Kim. 2013. Identification of surfactin as an aphicidal metabolite produced by Bacillus amyloliquefaciens G1. Journal of Korean Society for Applied Biological Chemistry, 56: 751-753.