### 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
Susanne Cerrelli Regulatory Action Leader

Microb ial Pesticides Branch Biopesticides Pollution Prevention Division (7511P)

703

- 308

- 8077(w)

EPA has received a pesticide petition ( 0F7698 

### ) from Premier Horticulture, 1, Avenue Premier, Riviere

- du

- Loup, Quebec, Canada 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 exemption from the requirement of a tolerance for

1. microbial pesticide Bacillus pumilus GHA

- 180

Pursuant to section 408(d)(2) (A)(i) of FFDCA, as amended, Premier Horticulture has submitted the following summary of information, data, and arguments in support of their pesticide petition. This summary was prepared by Premier Horticulture and GNL Consultation Services, LLC 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. Premier Horticulture Petition Summary

0F7698



### A. Product Name and Proposed Use Practices

The genus Bacillus is a group of bacteria with a long history of exploitation by mankind. It is one of the most ubiquitous and diverse of the bacterial genera, with representatives being found in the soil and associated water sources such as rivers, coastal waters, and estuaries. The metabolic diversity of Bacilli has led to members of this genus being used for a wide range of industrial purposes, including the production of enzymes, antibiotics, fine biochemicals and insecticides. One of the earliest reported uses of Bacillus was the fermentation of soybeans into Natto, a traditional Japanese fo od. Other related fermented food products, where Bacillus has been reported as the predominant organism, include Kinema, a meat

substitute.2

Bacillus pumilus specifically is a ubiquitous microorganism, commonly recovered from water, soil, air, and decompo sing plant residue. It is considered a benign bacterium as it does not possess traits that cause disease. It is not considered pathogenic or toxigenic to humans, plants, and animals. For specifics, see tox studies submitted and the waiver requests subm itted as part of the over all registration dossier.

B. pumilus is widely distributed throughout the environment. It does not appear to have any specialized attachment mechanism typically found in organisms capable of colonizing humans. Given its ubiquit y in nature and the environmental conditions under which it is capable of surviving, B. pumilus GHA 180 could be expected to temporarily inhabit the skin and gastrointestinal tract of mammals, but does not give any indication of colonizing other sites.

One reported use of B. pumilus is production and commercialization of food grade D

- ribose. This product, has obtained GRAS status from the US Food and Drug Administration Other reported uses were the fermentation of soybeans and other proteins. Use of Bacillus pumilus has also been reported in the agricultural sector of the United States and elsewhere, including a product commercialized by the AgraQuest company.



### B. Product Identity/Chemistry

1. Identity of the pesticide and corresponding residues

.

3. A statement of why an analyt ical method of detecting and measuring the levels of the pesticide residue are not needed.

An analytical method for residues is not applicable. Residues of Bacillus pumilus GHA

- 180 are not expected on agricultural commodities

.



### C. Mammalian Toxicologica l Profil e

Studies on the active ingredient include an acute oral toxicity/pathogenicity study in the rat, an acute dermal toxicity study in the rabbit, an acute pulmonary toxicity/pathogenicity study in the rat, an acute intravenous toxicity/pathogenicity study in the rat and a primary eye irritation study in the rabbit have shown no adverse toxicity. The active ingredient was not infective or pathogenic to test animals when administered via the oral, pulmonary and intravenous routes. No reports of hype rsensitivity have been recorded from personnel working with this organism

.

The results of toxicity testing indicate there is no ri sk to human health.



### D

. Aggregate Exposure

1. Dietary exposure.

i. Food.

Studies on the active ingredient include an acute oral toxicity/pathogenicity study in the rat, an acute dermal toxicity study in the rabbit, an acute pulmonary toxicity/pathogenicity study in the rat, an acute intravenous toxicity/pathogenicity study in the rat and a primary eye irritation stud y in the rabbit have shown no adverse toxicity. The active ingredient was not infective or pathogenic to test3

animals when administered via the oral, pulmonary and intravenous routes. No reports of hypersensitivity have been recorded from personnel work ing with this organism

.



### ii. Drinking water

. Similarly, exposure to humans from residues of Bacillus pumilus

GHA

- 180 in consumed drinking water would be unlikely. Bacillus pumilus GHA

- 180 is not known to grow or thrive in aquatic environments. Potentia l exposure to surface water would be negligible and exposure to drinking water (well or ground water) would be impossible to measure. The intended use of Bacillus pumilus GHA

- 180 is to suppress disease organisms. The risk of the microorganism passing th rough the soil to ground water is minimal to unlikely.

The results of toxicity testing indicate there is no risk to human health or the environment from Bacillus pumilus GHA

- 180

. There are no reports of ecological or human health hazards caused by

Baci llus pumilus in general or the strain Bacillus pumilus GHA

- 180 specifically . It does not produce recognized toxins, enzymes, or virulence factors normally associated with mammalian invasiveness or toxicity. The absence of acute toxicity or pathogenicity in laboratory animals demonstrates the benign nature of this strain.



### 2. Non

- dietary exposure

. The potential for non

- dietary exposure to the general population, including infants and children, is unlikely as the proposed use sites are a pplication to growing plants or crops.

The results of toxicity testing indicate there is no risk to human health or the environment

from Bacillus pumilus GHA

- 180 . There are no reports of ecological or human health hazards caused by Bacillus pumilus in general or the strain Bacillus pumilus GHA

- 180 specifically . It does not produce recognized toxins, enzymes, or virulence factors normally associated with mammalian invasiveness or toxicity. The absence of acute toxicity or pathogenicity in laboratory ani mals demonstrates the benign nature of this strain. The limited survival of Bacillus pumilus GHA

- 180 and the lack of acute toxicity indicate that both the hazard and the exposure associated with the use of Bacillus pumilus GHA

- 180 are low. Non

- dietary

exp osures would not be expected to pose any quantifiable risk due to a lack of residues of toxicological concern



### E . Cumulative Effects
It is not expected that, when used as proposed, Bacillus pumilus GHA

- 180 would result in residues

that are of toxicol ogical concern. The intended use of Bacillus pumilus GHA

- 180 is to suppress disease organisms as stated above. Bacillus pumilus GHA

- 180 is widely distributed around the world, including the U.S. Application of Bacillus pumilus GHA

- 180 will not result in a substantial increase in concentration in the

environment. The level of Bacillus pumilus GHA

- 180 in the environment following application will decrease to levels similar to naturally occurring concentrations. The results of toxicity testing

indicate there is no risk to human health or the environment from Bacillus pumilus GHA

- 180 . There are no reports of ecological or human health hazards caused by Bacillus pumilus in general or the

strain Bacillus pumilus GHA

- 180 CL 145A specifically

. It does not produce recognized toxins, enzymes, or virulence factors normally associated with mammalian invasiveness or toxicity. The absence of acute toxicity or pathogenicity in laboratory animals demonstrates the benign nature of

this strain. The limited survival of Bacillus pumilus GHA

- 180 and the lack of acute toxicity indicate that both the hazard and the exposure associated with the use of Bacillus pumilus GHA

- 180 are low

.4



### F

. Safety Determination

1. U.S. population.
Acute toxicity studies have sh own that Bacillus pumilus GHA

- 180 is not toxic, pathogenic, infective or significantly to mammals. The intended use of Bacillus pumilus GHA

- 180 is to suppress disease organisms. The level of Bacillus pumilus GHA

- 18 in the environment following appli cation will decrease to levels similar to naturally occurring concentrations. The results of toxicity testing

indicate there is no risk to human health or the environment from Bacillus pumilus GHA

- 180

. There are no reports of ecological or human health hazards caused by Bacillus pumilus in general or the

strain Bacillus pumilus GHA

- 180 CL 145 A specifically . It does not produce recognized toxins, enzymes, or virulence factors normally associated with mammalian invasiveness or toxicity. The

absence of a cute toxicity or pathogenicity in laboratory animals demonstrates the benign nature of

this strain. The limited survival of Bacillus pumilus GHA

- 180 and the lack of acute toxicity indicate that both the hazard and the exposure associated with the use of Ba cillus pumilus GHA

- 180 are low. There is a reasonable certainty of no harm to the general US population from exposure to this active ingredient

.



### 2. Infants and children

. As mentioned above, it is not expected that, when used as proposed, Bacillus pumilus GHA

- 180 would result in residues that are of toxicological concern. There is a reasonable certainty of no harm for infants and children from exposure to Bacillus pumilus

GHA

- 180 from the proposed uses.



### G. Effects on the Immune and Endocrine Syst ems

To date there is no evidence to suggest that Bacillus pumilus GHA

- 180 functions in a manner similar to any known hormone, or that it acts as an endocrine disrupter

H. Existing Tolerances

40 CFR 180.1111. There are strains of Bacillus pumilus with exemptions from the requirement of a

tolerance.

I. International Tolerance

A Codex Alimentarium Commission Maximum Residue Level (MRL) is not required for Bacillus pumilus GHA

- 180.