**EPA BIOPESTICIDES**  **AND POLLUTION**  **PREVENTION DIVISION** 

**COMPANY NOTICE OF FILING FOR PESTICIDE PETITIONS PUBLISHED IN THE FEDERAL REGISTER**  **EPA Biopesticides**  **and Pollution**  **Prevention Division**  **contact: [** **Kimberly Nesci**  **; (703) 308** 
**- 8059**  **]**

**INSTRUCTIONS: Please**  **utilize this**  **outline in**  **preparing the**  **pesticide petition.**  **I n**  **cases where**  **the outline**  **element does**  **not apply,**  **please insert**  **“NA**
**- Remove”**  **and maintain**  **the outline.**  **Please do**  **not change**  **the margins,**  **font, or**  **format in**  **your pesticide**  **petition. Simply**  **replace the**  **instructions that**  **appear in**  **green ,**  **i.e., “**  **[ insert**  **company name ]**  **,” with the information specific to your action. SUBMISSION:**  **E**
**- mail the completed template to:**  **hollis .** **linda @epa.gov.**  **TEMPLATE: [** **BASF Corporation ]**  **[ Petition No.**  **4F 8336** **]** EPA has received a pesticide petition **( [** **No. 4F8336** **] )**  from **[ BASF**  **Corporation ]**  **, [** **26 Davis**  **Drive, Research**  **Triangle Park,**  **NC 27709**  **]** proposing, pursuant to section 408(d) of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a(d), to amend 40 CFR part 180 to establish an amendment/exp ansion of an existing tolerance exemption for the microbial pesticide **[ Bacillus**  **am yloliquefaciens**  **M BI**  **600 (** **antecedent Bacillus subtilis**  **MBI 600 )**  **]** Pursuant to section 408(d)(2)(A)(i) of FFDCA, as amended, **[ BASF**  **Corporation ]**  has submitted the following summary o f information, data, and arguments in support of their pesticide petition. This summary was prepared by **[ BASF**  **Corporation ]**  and EPA has not fully evaluated the merits of the pesticide petition. The summary may have been edited by

EPA if the terminology used was unclear, the summary contained extraneous material, or the summary unintentionally made the reader conclude that the findings reflected EPA’s position and not the position of the petitioner. **I. [** **BASF Corporation ]**  **Petition Summary [** **Petition No.**  **4F 8336**  **to AMEND**  **40 CFR**  **§ 180.1128**  **Bacillus subtilis**  **MBI 600;**  **exemption from**  **the requirement**  **of a**  **tolerance ;**  **to change**  **the species**  **name to “ amyloliquefaciens”**  **and revise the exemption to state as follows:**2

**“ 40**  **CFR §**  **180.1128 Bacillus**  **am yloliquefaciens**  **MBI 600;**  **exemption from the requirement of a tolerance**  **. An**  **exemption from**  **the requirement**  **of a**  **tolerance is**  **established for**  **residues of**  **the biofungicide**  **Bacillus am**  **yloliquefaciens MBI**  **600 (** **antecedent Bacillus**  **subtilis MBI**  **600 )**  **in or**  **on all**  **food commodities,**  **including residues**  **resulting from**  **post -** **harvest uses,**  **when applied**  **or used in accordance with good agricultural practices.”**  **]** A. Product Name and Proposed Use Practices **[ Following is a list of all the currently EPA**  **registered pesticide products that**  **will be affected by the change in the species name from subtilis**  **to am**  **yloliquefaciens .**  **EPA Registration No. Product Name** * **71840**
**- 1**  **Subtilex® MUP 71840** 
**- 2**  **HiStick® NT 71840** 
**- 5**  **Integral® Liquid Biological Fungicide 71840** 
**- 6**  **Integral® II Liquid Biofungicide 71840** 
**- 8**  **Subtilex® NG Biofungicide 71840** 
**- 9**  **Bacillus subtilis strain**  **MBI 600 Technical**  *** Serifel Biofungicide (EPA Registration No. 71840**
**- 18 is already registered with the**  **amyloliquefaciens species**  **designation**

. **The end**
**- use products containing the MBI 600**  **Integral® , Integral® II, HiStick®**  **NT Subtilex ® NG, SUBTILEX® MUP, and**  **Bacillus subtilis strain**  **MBI 600 Technical**  **biological fungicide products and are currently used to suppress disease**  **organisms such as Botrytis** **, Fusarium**  **, Rhizoctonia** **, and Alternaria**  **as well as those organisms causing powdery mildew and anthracnose**  **. Current use sites include commercial application for seed treatment, foliar, in** 
**** **furro w,**  **injected and soil**  **drench applications for**  **greenhouse and**  **field crops and ornamentals.**  **The use patterns and application rates of Bacillus**  **am yloliquefaciens**  **MBI 600 (antecedent**  **Bacillus subtilis MBI 600)**  **minimize the potential for exposure above the natural background levels.** 

B. Product Identity/Chemistry3
1. Identity of the pesticide and corresponding residues. **[ Bacillus**  **amyloliquefaciens MBI**  **600 (antecedent**  **Bacillus subtilis**  **MBI 600** **) ;**  **CAS No.**  **68083**
**- 70** 
**- 0**  **. When**  **used as**  **directed, Bacillus**  **amyloliquefaciens MBI**  **600 is not expected to result in residues that are of toxicological concern.**  **Bacillus amyloliquefaciens is a naturally occurring soil saprophyte that is**  **found in soils worldwide. Strains of this organism are generally not regarded as human or animal pathogens.**  **Bacillus amyloliquefaciens MBI 600**  **(antecedent Bacillus subtilis**  **MBI 600) was first isolated fr** **om faba bean plants growing at Nottingham University School of**  **Agriculture in Sutton Boningham, UK. This strain was subsequently researched, developed, and commercialized by Gustafson, LLC (first**  **registered as EPIC Biological Fungicide in 1994). The regist ration**  **transferred to MicroBio in 1998 and transferred again to Becker Underwood following their acquisition of MicroBio in 2000.**  **In 2013, BASF Corporation acquired Becker Underwood and currently**  **owns all Becker Underwood pesticide product registrations a nd**  **associated data submitted in support of those registrations. ]** 
2. Magnitude of residues at the time of harvest and method used to determine the residue

. **[ An analytical method for residues is n** **ot applicable .]**  3. A statement of why an analytical method of detecting and measuring the levels of the pesticide residue are not needed. **[ An**  **analytical method**  **for residues**  **of Bacillus**  **amyloliquefaciens MBI 600**  **(antecedent Bacillus subtilis**  **MBI 600 )**  **is not necessary as Bacillus**  **am**

**yloliquefaciens MBI**  **600 (antecedent**  **Bacillus subtilis**  **MBI 600** **) has**  **an exemption from the requirement of a tolerance without numerical limitations**  **.]** C. Mammalian Toxicological Profile **[ Toxicology and pathogenicity studies on**  **Bacillus amyloliquefaciens MBI 600**  **(antecedent Bacillus subtilis**  **MBI 600 )**  **were previously accepted by the EPA to support the current exemption from the requirement of a tolerance for residues of**  **MBI 600 .**  **The data consist of laboratory animal (in vivo) toxicity studies conducted in accordance with Good Laboratory Practice.**  1. **Acute Oral Toxicity/Pathogenicity: (MRID 419074** 
**- 02)**  **Bacillus amyloliquefaciens**  **MBI 600 was not pathogenic, infective or toxic in rats when orally dosed with 2 x 10**  **8 CFU per animal. Toxicity category IV.**  2. **Acute Dermal Toxicity: (MRID 419074** 
**- 03)**  **Bacillus amyloliquefaciens MBI**  **600 was not toxic for rats when a single 5 x 10**  **10 CFU/animal (2 ml/kg body**  **weight) dose was administered dermally to rabbits. Toxicity category IV.**  3. **Acute Pulmonary Toxicity/Pathogenicity: (MRID 419074** 
**- 04**  **Bacillus amyloliquefaciens**  **MBI 600 was not infective, pathogenic or toxic to rats**  **dosed intratracheally with 3.4 x 10 8**  **CFU of the test material. Toxicity category IV.** 4

4. **Acute Intravenous Toxicity/Pathogenicity: (MRID 419074** 
**- 05)**  **Bacillus amyloliquefaciens**  **MBI 600 was not infective, pathogenic or toxic for rats**  **when dosed intravenously with approximately 4 x 10 7**  **CFU of the test ma** **terial.** 5. **Primary Eye Irritation: (MRID 41907** **4**
**- 06)**  **Bacillus amyloliquefaciens MBI**  **600 produced a slight irritation when a single 0.1 g ocular does was**  **administered to rabbits. Occular irritation dissipated 4 days post dosing. Toxicity category IV.**  6. **Hypersensitivity Studies: (MRID 419074** 
**- 07, April 198**  **9) An overall moderated skin sensitization reaction was noted in guinea pigs 24 to 72 hours**  **after treatment with Bacillus amyloliquefaciens**  **MBI 600 . (MRID 462059** 
**- 01,**  **December 2003) No irritation was observe after the challenge with SUBTILEX® Biological Fun**  **gicide indicating the product does not elicit a sensitizing reaction in guinea pigs and does not appear to be a dermal**  **sensitizer.** 7. **Hypersensitivity incidents: To date, there are no reports of incidents of**  **human health or ecological hazards from exposure t** **o Bacillus**  **amyloliquefaciens MBI 600**  **. Results of these studies indicate the**  **Bacillus amyloliquefaciens MBI 600**  **(antecedent Bacillus subtilis**  **MBI 600) is not toxic to test animals when administered via the oral,**  **dermal, pulmonary or intravenous routes of exposure. Additionally, it is not infective or pathogenic when administered via the oral, pulmonary or intravenous**  **routes. Because of the lack of toxic ity, pathogenicity, and infectivity, the EPA**  **concluded the product should not pose a risk to wild mammalian species. No reports of hypersensitivity have been recorded from personnel working with this**  **organism. MBI 600 does not produce significant quantiti es of extracellular enzymes**  **or possess other virulence factors that would predispose it to cause infection. Based on the studies and other available information submitted for**  **Bacillus amyloliquefaciens**  **MBI 600 (antecedent**  **Bacillus subtilis MBI 600)**  **, the E PA found**  **no evidence of risks to human health. ]**  D. Aggregate Exposure 1. Dietary exposure. **[]**
i. Food. **[ The**  **proposed use**  **pattern may**  **result in**  **dietary exposure**  **with possible residues in or on agricultural commodities. However, little to no risk**  **is expected**  **f**

**or the**  **general population,**  **including infants**  **and children,**  **or animals**  **because of**  **the lack**  **of demonstr**  **ated toxicity/pathogenicity**  **of Bacillus**  **am**

**yloliquefaciens MBI 600.**  **Furthermore, Bacillus**  **am yloliquefaciens**  **is used**  **in the**  **production of**  **fermented foods**  **and commonly**  **consumed by**  **humans with**  **no adverse**  **health effects.**  **Additionally, Bacillus**  **amyloliquefaciens is**  **commonly used**  **on a**  **large, industrial**  **scale basis**  **to produce food grade products.** 5
**A cute**  **dietary assessments**  **were conducted**  **on October**  **10, 1993**  **in a**  **Science Advisory**  **Board (SAB)**  **review for**  **the registration**  **of a**  **Bacillus subtilis**  **( amyloliquefaciens** 

**) MBI**  **600 concentrate**  **product. No**  **toxicological end**  **points of**  **concern were**  **identified. There**  **are no**  **dietary risks**  **that exceed**  **the Agency’s Level of Concern (LOC).**  **]** ii. Drinking water

. **[ The**  **potential for**  **transfer of**  **Bacillus am**  **yloliquefaciens MBI**  **600 to**  **surface or**  **ground water**  **during run** **- off**  **associated with**  **intended use**  **applications is**  **considered minimal**  **to non** **- existent,**  **due to**  **its percolation**  **through ,**  **and resulting**  **capture in**  **soil. Accordingly,**  **the use**  **of this**  **microbial pest**  **control agent**  **on terrestrial plants is not anticipated to negatively impact**  **the quality of drinking water. ]**  2. Non

-dietary exposure . **[ The**  **potential for**  **dermal exposure**  **to pesticide**  **residues of**  **Bacillus am** 

**yloliquefaciens MBI**  **600 for**  **the general**  **population, including**  **infants and**  **children, is**  **unlikely as**  **the use**  **sites are**  **limited to**  **agricultural and**  **horticultural applications.**  **In addition,**  **as the**  **microbe is**  **a ubiquitous,**  **naturally occurring**  **soil bacterium,**  **it is**  **likely many**  **individuals have**  **had prior**  **exposure. Accordingly,**  **any potential**  **increase in**  **dermal exposure**  **due to**  **pesticidal use**  **of Bacillus**  **amyloliquefaciens MBI**  **600 would**  **be inconsequential.**  **Furthermore, as**  **summarized previously, MBI 600 is of low dermal toxicity** 
**- Tox** **icity Category IV. Similarly,**  **the inhalation**  **exposure to**  **pesticide residues**  **of Bacillus**  **amyloliquefaciens MBI**  **600 for**  **the general**  **population, including**  **infants and**  **children is**  **unlikely because**  **potential use**  **sites are**  **agricultural and**  **horticultural. Also,**  **as stated**  **before, the**  **microbe is a ubiquitous, naturally occurring soil bacterium, and it is likely many individuals**  **have had**  **prior exposure.**  **The acute**  **pulmonary toxicity/pathogenicity**  **testing of**  **Bacillus amyloliquefaciens**  **MBI 600**  **demonstrated it**  **is neith**  **er toxic,**  **pathogenic nor**  **infective**
**- Toxicity**  **Category IV**  **Therefore, any**  **potential increase**  **in inhalation**  **exposure due**  **to pesticidal**  **use of**  **Bacillus am**  **yloliquefaciens MBI**  **600 would be inconsequential.**  **The results**  **of toxicity**  **testing indicate**  **there is**  **no risk**  **to human**  **health or**  **the environment**  **from Bacillus**  **am yloliquefaciens**  **MBI 600.**  **It is**  **not toxic**  **to test**  **anim als**  **when administered**  **via the**  **oral, dermal,**  **intravenous or**  **pulmonary routes**  **of exposure.**  **Nor is it**  **infective or pathogenic to test animals when administered via the**  **oral, pulmonary**  **and intravenous**  **routes. In**  **addition, n**  **o reports**  **of hypersensitivity**  **have been recorded from personnel working with this organism. MBI**  **600 does**  **not produce**  **recognized toxins,**  **enzymes, or**  **virulence factors**  **normally associated**  **with ma** **mmalian invasiveness**  **or toxicity.**  **T he**  **limited survival**  **of MBI**  **600 and**  **the lack**  **of acute**  **toxicity indicate**  **that both**  **the hazard**  **and the**  **exposure associated**  **with the**  **use of**  **MBI 600**  **are low.**  **N on** **- dietary**  **exposures would**  **not be**  **expected to**  **pose any**  **quantifiable risk**  **due to**  **a lack**  **of residues**  **of toxicological concern**  **.]**6

E. Cumulative Effects **[ Bacillus**  **am**

**yloliquefaciens MBI**  **600 is**  **non -** **toxic to**  **ma mmals.**  **Because no**  **mechanism of**  **pathogenicity or**  **toxicity in**  **mammals has**  **been identified**  **for this**  **organism, no cumulative effects from the interaction of residues of this product with other**  **related microbial**  **pesticides are**  **anticipated when**  **this product**  **is used**  **as directed**  **on the**  **label and**  **in accordance**  **w ith**  **good agricultural/horticultural**  **practices. It**  **is not**  **expected that,**  **when used**  **as directed,**  **Bacillus am**  **yloliquefaciens MBI**  **600 would**  **result in**  **residues that**  **are of**  **toxicological concern.**  **The intended**  **use of**  **Bacillus am** 

**yloliquefacie ns**  **MBI 600**  **is to**  **apply it**  **to growing**  **med ia,**  **seeds, and**  **growing plants**  **and crops**  **for the**  **purposes of**  **disease control.**  **Bacillus amyloliquefaciens**  **is widely distributed in the US and around the world. Application of**  **Bacillus am** 

**yloliquefaciens MBI**  **600 to**  **see ds,**  **foliage or**  **soil will**  **not result**  **in any**  **significant increases**  **in overall**  **concentrations of**  **Bacillus am**  **yloliquefaciens in**  **the environment.**  **The results**  **of toxicity**  **testing indicate**  **there is**  **no risk**  **to human**  **health or**  **the environment**  **from Bacillus**  **am yloliquefaciens**  **MBI 600.**  **There are**  **no reports**  **of ecological**  **or human**  **health hazards**  **caused by**  **Bacillus am**  **yloliquefaciens in**  **general or**  **the Bacillus**  **am**

**yloliquefaciens MBI**  **600 in**  **specific. MBI**  **600 does**  **not produce**  **significant quantities of extracellular e nzymes or possess other virulence factors that**  **would predispose it to cause infection. The absence of acute toxicity or pathogenicity in laboratory animals demonstrates the**  **benign nature of this .**  **]**
F . Safety Determination 1. U.S. population. **[ There**  **is reasonable certainty that no harm to the**  **US population, including**  **infants and**  **children, will**  **result from**  **aggregate exposure**  **to residues**  **of Bacillus**  **am**

**yloliquefaciens MBI**  **600 from**  **its use**  **as a**  **mi crobial**  **pest control**  **agent. The**  **results of**  **toxicity t** **esting indicate**  **there is**  **no risk**  **to human**  **health or**  **the environment**  **from Bacillus**  **am yloliquefaciens**  **MBI 600.**  **It is**  **not toxic**  **to test**  **animals when**  **administered via**  **the oral,**  **dermal, intravenous**  **or pulmonary**  **routes of**  **exposure. Nor is it**  **infective or pathogenic to test animals when administered via the**  **oral, pu** **lmonary and**  **intravenous routes.**  **Bacillus am**  **yloliquefaciens MBI**  **600 does**  **not produce**  **recognized toxins,**  **enzymes, or**  **virulence factors**  **normally associated**  **with mammalian**  **invasiveness or**  **toxicity. In**  **addition, n**  **o reports**  **of hypersensitivity**  **have been recorded from personnel working with this organism. ]** 
2. Infants and children

. **[ For the same reasons stated previously, there is**  **reasonable certainty that no harm to infants and children will result from aggregate exposure to residues of**  **Bacillus am**  **yloliquefaciens MBI 600 from its use as a**  **microbial pest control agent. ]** 7

G. Effects on the Immune and Endocrine Systems **[ There is no evidence to date suggesting**  **Bacillus amyloliquefaciens**  **MBI 600 functions in a manner similar to any known hormone, or that it acts as an endocrine**  **disrupter .]**  H. Existing Tolerances **[ 40 CFR 180.1128**  **Bacillus subtilis**  **MBI 600; exemption from the requirement of a**  **tolerance .** 

**“ An**  **exemption from**  **the requirement**  **of a**  **tolerance is**  **established for** 

**residues of the biofungicide Bacillus**  **subtilis MBI**  **600 in or on all food**  **commodities, including**  **residues resulting**  **from post** **- harvest**  **uses, when**  **applied or**  **used in**  **accordance with**  **good agricultural**  **practices.”** ] I . International Tolerances **[ A Codex Alimentarium Commission Maximum Residue Level (MRL) is not**  **required for Bacillus**  **am yloliquefaciens**  **MBI 600 .]**