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

Microbial 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 food. Other related fermented food 

products, where Bacillus has been reported as the predominant organism, include Kinema, a meat 

substitute.
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Bacillus pumilus specifically is a ubiquitous microorganism, commonly recovered from water, soil, air, and 

decomposing 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 submitted 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 ubiquity 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 analytical 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 Toxicological Profile

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 

hypersensitivity have been recorded from personnel working with this organism.

The results of toxicity testing indicate there is no risk 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 study in the 

rabbit have shown no adverse toxicity. The active ingredient was not infective or pathogenic to test 
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animals when administered via the oral, pulmonary and intravenous routes. No reports of 

hypersensitivity have been recorded from personnel working 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. Potential 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 through 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

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 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 application 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 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. Non-dietary 

exposures 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 toxicological 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.
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F. Safety Determination

1. U.S. population.

Acute toxicity studies have shown 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 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 145 A 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. 

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 Systems

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.