BIOPESTICIDES REGISTRATION ACTION DOCUMENT

Bacteriophage of Clavibacter michiganensis subspecies michiganensis 

Pesticide Chemical (PC) Code: 228983

U.S. Environmental Protection Agency

Office of Pesticide Programs

Biopesticides and Pollution Prevention Division

August 25, 2011
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TABLE OF CONTENTS

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

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

A. Application for Pesticide Registration....................................................................................................7

B. North American Free Trade Agreement Joint Review .........................................................................7

C. Food Tolerance Exemption......................................................................................................................7

IV. RISK ASSESSMENT ....................................................................................................... 7

A. Product Analysis Assessment (40 CFR § 158.2120)...............................................................................8

B. Human Health Assessment (40 CFR § 158.2140)...................................................................................8

C. Environmental Assessment (40 CFR § 158.2150) ................................................................................13

V. ENVIRONMENTAL JUSTICE.................................................................................... 14

VI. RISK MANAGEMENT DECISION............................................................................. 14

VII. ACTIONS REQUIRED BY THE REGISTRANT ...................................................... 15

A. Final Printed Labeling ...........................................................................................................................15

B. Terms of Registration.............................................................................................................................15

C. Reporting of Adverse Effects and Hypersensitivity Incidents............................................................16

VIII. GLOSSARY OF ACRONYMS AND ABBREVIATIONS........................................... 17

IX. BIBLIOGRAPHY........................................................................................................... 18

A. Studies Submitted to Support the AgriPhage CMM Pesticide Product Registration ......................18

B. Environmental Protection Agency and Pest Management Regulatory Agency Risk Assessment 

Memoranda..................................................................................................................................................18

APPENDIX A. MICROBIAL PESTICIDES DATA REQUIREMENTS............................. 20

APPENDIX B. PESTICIDE PRODUCTS................................................................................ 22
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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, Environmental Effects, 

Human Health

U.S. Environmental Protection Agency 

Jonas Ptasinski Product Analysis, Environmental Effects, 

Human Health

Health Canada Pest Management Regulatory Agency 

Regulations

Sheryl K. Reilly, Ph.D. Chief, Microbial Pesticides Branch

U.S. Environmental Protection Agency 

Denise Greenway Regulatory Action Leader

Anna Gross Regulatory Action Leader

Matthew Thompson Regulatory Action Leader
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I. EXECUTIVE SUMMARY

In March 2009, OmniLytics, Inc. submitted an application for an end-use pesticide product, 

AgriPhage CMM (EPA File Symbol 67986-A), to both the United States Environmental 

Protection Agency (EPA) and the Health Canada Pest Management Regulatory Agency 

(PMRA), and requested a North American Free Trade Agreement (NAFTA) Joint Review of its 

application. AgriPhage CMM contains a new active ingredient, bacteriophage of Clavibacter 

michiganensis subsp. michiganensis, and is proposed for use as a bactericide on tomato plants to 

control bacterial canker disease. AgriPhage CMM is composed of individually derived mixtures 

of a library of bacteriophages with specific activity for lysing Clavibacter michiganensis subsp. 

michiganensis pathogenic to tomatoes.

Bacteriophages are viruses that only infect specific bacteria. Clinical uses encompass all manner 

of administration from injection/intravenous and surgical wound applications, to topical and 

ingestible preparations. They are also used to test normal and variously impaired human immune 

system functions. There have been no reports of adverse effects from such administrations of 

bacteriophage in the published literature or in scientifically controlled case studies. Literature 

cited by the applicant demonstrated that bacteriophages are present in high numbers in the 

environment, including non-polluted waters up to 1010 PFU/L and up to 105 PFU/L in treated 

drinking water. Bacteriophage presence has been reported in foods and feeds ranging from 10-

105 PFU/100 g in meats and up to 107 PFU/100 g in cheese, without any known harmful effects 

after consumption. Bacteriophages are common and abundant in soils and in a wide range of 

plant materials. 

The main risk issue associated with the use of bacteriophage as a pesticide is whether any or all of 

the bacteriophages in the library and the host bacterium produce toxins or pathogenicity factors. 

Peer-reviewed literature, analysis of the host strain, and the bacteriophage properties submitted by 

the applicant showed the host strains do not produce toxic or pathogenic factors. Host range testing 

verified that the bacteriophage cannot cross-infect bacteria that may carry toxins. 

EPA and PMRA scientists have reviewed product analysis, toxicology, and nontarget organism

data and information submitted to support the registration of the bacteriophage of Clavibacter 

michiganensis subsp. michiganensis pesticide product. Product analysis data requirements for 

bacteriophage of Clavibacter michiganensis subsp. michiganensis, including product chemistry 

and composition, analysis of samples, and physical and chemical characteristics, were fulfilled

by acceptable guideline studies. The applicant included a thorough scientific literature review,

and requested the EPA to waive the data requirements for mammalian and nontarget organism

toxicology, pathogenicity, infectivity and irritation testing for bacteriophage of Clavibacter 

michiganensis subsp. michiganensis, based upon its biological properties and narrow host range. 

EPA accepted the waivers of these data requirements, because the submitted literature 

demonstrated that bacteriophages are unable to infect eukaryotic cells. It is reasonable, therefore, 

to expect that they are not capable of infecting eukaryotic organisms, including humans and

nontarget animals and plant species, and no bacteriophage infections of eukaryotic organisms 

have been reported. Nontarget bacteria are also unlikely to be adversely affected, due to the 

narrow host range of the bacteriophage.

EPA has made a preliminary conclusion that there is a reasonable certainty that no harm will result 

to the United States population, including infants and children, from aggregate exposure to residues 

of bacteriophage of Clavibacter michiganensis subsp. michiganensis. Based on the narrow host 
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range of bacteriophage of Clavibacter michiganensis subsp. michiganensis to certain bacterial 

species and the inability of bacteriophage in general to infect eukaryotic cells, bacteriophage of 

Clavibacter michiganensis subsp. michiganensis are not expected to pose any singular or 

cumulative risks to humans, including infants and children, or to other mammals through exposure 

in the food supply, from drinking or surface waters, or through other non-dietary exposures. In 

addition, nonoccupational exposure is considered unlikely for bacteriophage of Clavibacter 

michiganensis subsp. michiganensis as all currently proposed uses occur in distinctly agricultural or 

commercial settings; there are no proposed uses for residential areas.

Despite the low toxicological profile of bacteriophage of bacteriophage of Clavibacter 

michiganensis subsp. michiganensis, baseline personal protective equipment (PPE) is required 

for handlers that may be exposed to the active ingredient, due to their occupation, for prolonged 

periods or numerous times. Handlers working with bacteriophage of Clavibacter michiganensis

subsp. michiganensis in occupational and agricultural settings are directed to wear a long-sleeved 

shirt, long pants, socks, shoes, and waterproof gloves; 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 is required for workers when repeated inhalation exposures occur.

The submitted data and other information fulfilled the current data requirements and were

adequate for risk assessment purposes. EPA has concluded that the proposed use of 

bacteriophage of Clavibacter michiganensis subsp. michiganensis meets the safety standards for 

registration under Section 3(c)(5) of the Federal Insecticide, Fungicide, and Rodenticide Act 

(FIFRA).

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

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

policy, EPA intends to provide a public comment period prior to making a registration decision 

for, at minimum, the following types of applications: new active ingredients; first food uses; first 

outdoor uses; first residential uses; or any other registration actions for which EPA believes there 

may be significant public interest.

 

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

pesticide product containing bacteriophage of Clavibacter michiganensis subsp. michiganensis, a 

new active ingredient, is subject to a 30-day comment period. In addition to containing a new 

active ingredient, the registration of this product would result in both the first outdoor use and 

first food use for bacteriophage of Clavibacter michiganensis subsp. michiganensis. The docket 

identification number, associated with these registration actions and accessed through either 

http://www.regulations.gov/ or http://www.epa.gov/pesticides/regulating/registration-status.html, 

is EPA-HQ-OPP-2009-0539. The following documents are available for comment in EPA-HQOPP-2009-0539: (1) proposed bacteriophage of Clavibacter michiganensis subsp. michiganensis

Biopesticides Registration Action Document (BRAD); (2) environmental risk assessment for 

bacteriophage of Clavibacter michiganensis subsp. michiganensis; and (3) proposed product 

label for the end-use pesticide product, AgriPhage CMM (EPA File Symbol 67986-A). While a 

final decision on registration is contingent upon review and consideration of public comments, 

EPA presently believes that, based upon the risk assessment and information submitted in 

support of AgriPhage CMM, it is in the best interest of the public and the environment to issue 

this registration. The basis for this preliminary decision can be found in the risk assessment for

bacteriophage of Clavibacter michiganensis subsp. michiganensis, which is characterized 

throughout this BRAD. 
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II. ACTIVE INGREDIENT OVERVIEW

Biological Name: Bacteriophage of Clavibacter michiganensis subsp. 

michiganensis

OPP Chemical Code: 228983

Type of Pesticide: Microbial Pesticide – Bactericide

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

application rates, methods of application, formulation 

types, and target pests) regarding the pesticide product

containing this active ingredient.
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III. REGULATORY BACKGROUND

A. Application for Pesticide Registration

On March 23, 2009, OmniLytics, Inc. (address: 9100 South 500 West, Sandy, Utah 84070)

submitted an application to register an end-use pesticide product, AgriPhage CMM (EPA File 

Symbol 67986-A), under FIFRA section 3. On March 10, 2010, EPA announced receipt of this 

application to register a pesticide product containing a new active ingredient (75 Federal Register 

(FR) 11175) 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. North American Free Trade Agreement Joint Review

Bacteriophage of Clavibacter michiganensis subsp. michiganensis was the subject of a North 

American Free Trade Agreement joint registration review conducted by the Environmental 

Protection Agency Office of Pesticide Programs and the Health Canada Pest Management 

Regulatory Agency (PMRA). The PMRA “Proposed Registration Decision,” a consultation 

document recommending full registration of bacteriophage of Clavibacter michiganensis subsp. 

michiganensis, is being drafted, prior to a 45-day public comment period. 

C. Food Tolerance Exemption

Concurrent with its registration application and under Federal Food, Drug, and Cosmetic Act 

(FFDCA) section 408(d), OmniLytics, Inc. submitted a petition to establish an exemption from 

the requirement of a tolerance for bacteriophage of Clavibacter michiganensis subsp. 

michiganensis (Pesticide Petition (PP) 9E7552). In the Federal Register of September 23, 2009

(74 FR 48556), EPA announced that Interregional Research Project Number 4 (IR-4), Rutgers 

University, on behalf of OmniLytics, Inc., proposed to establish an exemption from the 

requirement of a tolerance for residues of the microbial pesticide, bacteriophage of Clavibacter 

michiganensis subsp. michiganensis, in or on tomato and opened a 30-day comment period. No 

comments were received following this publication. 

IV. RISK ASSESSMENT

In the Federal Register of October 26, 2007, EPA issued a Final Rule on the data requirements to 

support registration of microbial pesticides and updated the definition for microbial pesticides 

(72 FR 61002). The rule became effective on December 26, 2007. 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 EPA 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,” 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 CFR Part 158. Both “acceptable” and 

“supplemental” studies may be used in the risk assessment process as appropriate. An 
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“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 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 (40 CFR § 156.62). 

A. Product Analysis Assessment (40 CFR § 158.2120)

All product analysis data requirements for bacteriophage of Clavibacter michiganensis subsp. 

michiganensis have been fulfilled (Master Record Identification Numbers (MRID Nos.) 477204-

01, 480536-01 and 483831-01). Refer to Tables 1 and 2 in Appendix A for a brief summary of 

the data requirements. 

B. Human Health Assessment (40 CFR § 158.2140)

1. Toxicity

All toxicology data requirements for bacteriophage of Clavibacter michiganensis subsp. 

michiganensis have been fulfilled. Acceptable Tier I mammalian toxicology data waiver 

rationales support registration of bacteriophage of Clavibacter michiganensis subsp. 

michiganensis pesticide product. Furthermore, Tier II and Tier III studies were not required for

bacteriophage of Clavibacter michiganensis subsp. michiganensis based on data waiver 

rationales provided for Tier I toxicity/pathogenicity studies. Refer to Table 3 in Appendix A for a 

brief summary of the data requirements. 

a. Acute Toxicity/Pathogenicity – Tier I

The applicant included a thorough literature review and set of rationales to waive requirements 

for toxicology, pathogenicity, infectivity, and irritation testing for bacteriophage of Clavibacter 

michiganensis subsp. michiganensis (MRID No. 477204-02). The submitted literature

established that bacteriophage have been used historically and through modern times in lieu of,

or to assist the action of, antibiotics. Clinical uses encompass all manner of administration from 

injection/intravenous and surgical wound applications to topical and ingestible preparations. 

They are also used to test normal and variously impaired human immune system function. There 

have been no reports of adverse effects from such administrations of bacteriophage in the 

published literature or in cases using controlled scientific studies. Also submitted were literature 

citations showing that bacteriophage are present in high numbers in the environment, including 

in non-polluted waters up to 1010 PFU/L and up to 105 PFU/L in treated drinking water. EPA 

granted the data waiver requests based on submitted literature and rationale. 

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

 Reproductive Fertility Effects, Carcinogenicity, Immunotoxicity, and 

 Infectivity/Pathogenicity Analysis – Tier III

Tier II and Tier III studies were not required for bacteriophage of Clavibacter michiganensis

subsp. michiganensis based on the lack of acute toxicity/pathogenicity in the Tier I data waiver 
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rationales, and a Toxicity Category IV has been determined for bacteriophage of Clavibacter 

michiganensis subsp. michiganensis product Agriphage Cmm.

c. Endocrine Disruptors

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

Screening Program (EDSP) 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.” The EDSP employs a two-tiered approach to making the statutorily required 

determinations. Tier 1 consists of a battery of 11 screening assays to identify the potential of a 

chemical substance to interact with the estrogen, androgen, or thyroid (E, A, or T) hormonal 

systems. Chemicals that go through Tier 1 screening and are found to have the potential to 

interact with E, A, or T hormonal systems will proceed to the next stage of the EDSP where EPA 

will determine which, if any, of the Tier 2 tests are necessary based on the available data. Tier 2 

testing is designed to identify any adverse endocrine-related effects caused by the substance, and 

establish a quantitative relationship between the dose and the E, A, or T effect.

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

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

This list of chemicals was selected based on the potential for human exposure through pathways 

such as food and water, residential activity, and certain post-application agricultural scenarios. 

This list should not be construed as a list of known or likely endocrine disruptors.

Bacteriophage of Clavibacter michiganensis subsp. michiganensis is not among the group of 58 

pesticide active ingredients on the initial list to be screened under the EDSP. Under FFDCA 

section 408(p), EPA must screen all pesticide chemicals. Accordingly, EPA anticipates issuing 

future EDSP orders/data call-ins for all pesticide active ingredients. 

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:

http://www.epa.gov/endo/.

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

Section 408(c)(2)(A)(i) of FFDCA allows 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 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 section 408(c)(2)(B) 

of FFDCA, in establishing or maintaining in effect an exemption from the requirement of a 

tolerance, EPA must take into account the factors set forth in section 408(b)(2)(C) of FFDCA, 

which require 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, section 408(b)(2)(D) of FFDCA requires that 

EPA consider “available information concerning the cumulative effects of [a particular 
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pesticide's] . . . residues and other substances that have a common mechanism of toxicity.”

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

residues. First, EPA determines the toxicity of pesticides. Second, 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 section 408(b)(2)(D) of FFDCA, EPA has reviewed the available scientific data 

and other relevant information and considered its validity, completeness, and reliability and the 

relationship of this information to human risk. EPA has 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 information discussed previously and presented in 

Table 3 in Appendix A, the data required for a FFDCA risk assessment for bacteriophage of 

Clavibacter michiganensis subsp. michiganensis have been fulfilled.

a. Aggregate Exposure

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

information concerning exposures from the pesticide residue in food and all other 

nonoccupational 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: All bacteriophages, including those at issue in this 

action, are similar in nature in that they are host-specific, attacking only bacteria. Published 

scientific literature submitted by the registrant, and other publically available literature indicate 

that humans are exposed to bacteriophages daily, and are commonly found in humans, with no 

known adverse effects. Indeed, humans and other animals routinely consume bacteriophages

when they eat food such as meat and cheese. Several studies have suggested that 100% of the 

ground beef and chicken meat sold at retail contain various levels of various bacteriophage. For 

example, bacteriophages were recovered from 100% of examined fresh chicken and pork 

sausage samples and from 33% of delicatessen meat samples analyzed. The levels ranged from 

3.3-4.4x1010 PFU/100g of fresh chicken, up to 3.5x1010 PFU/100g of fresh pork, and up to 

2.7x1010 PFU/100g of roast turkey samples. Bacteriophages recovered were typically in the 

range of 101-105 PFU/100 g meats and up to 107 PFU/100 g in cheese. Based on the above and 

the fact that bacteriophages are host-specific; these organisms are not known to pose any human 

health effects. Throughout the literature cited by the registrant and other publically available

literature, there have been no known adverse effects to humans ever reported. Accordingly, the 

Agency concludes that when Clavibacter michiganensis subsp. michiganensis specific 

bacteriophages are used according to the manner intended, there is a reasonable certainty that no 

harm will result to humans from all anticipated dietary exposures (through food) to any residues 

resulting from such use. Bacteriophages are ubiquitous in the environment; therefore, humans 

and other mammals are regularly exposed to bacteriophages with no adverse effects reported in 

the published scientific literature. A literature review showed bacteriophages are already 

commonly consumed by humans via various foods. Bacteriophage may contain genes for 

substances that may be toxic or associated with pathogenicity, however, they are incapable of 

producing toxins outside host bacteria. Bacteriophages consist solely of genetic material 

encapsulated in a protein envelope and do not have the metabolic processes required for toxin 
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production. 

Drinking Water Risk Characterization: Bacteriophage of Clavibacter michiganensis subsp. 

michiganensis are not intended for use in drinking water, nor are the approved uses likely to 

result in these bacteriophages reaching surface water or ground water that might be used as 

drinking water. Furthermore, in the unlikely event that bacteriophage of Clavibacter 

michiganensis subsp. michiganensis do reach water consumed by humans, for the many reasons 

enumerated above, the Agency concludes that when bacteriophage of Clavibacter michiganensis 

subsp. michiganensis are used in the manner intended, there is a reasonable certainty that no 

harm will result to humans from all anticipated dietary exposures (through water) to any residues 

resulting from such use. Exposure of humans to bacteriophage of Clavibacter michiganensis

subsp. michiganensis in drinking water due to its proposed uses as a pesticide is not likely, as the 

proposed use patterns and use sites do not include direct application to aquatic environments, 

thereby limiting contact with surface water. If oral exposure should occur through consumed 

drinking water, however, EPA concludes that there is a reasonable certainty that no harm will 

result from exposure to such residues because of the lack of toxicity, infectivity, and or 

pathogenicity in the previously described toxicological studies (see section IV(B)(1)(a) and 

Table 3 in Appendix A).

Nonoccupational, Residential Risk Characterization: Since bacteriophage of Clavibacter 

michiganensis subsp. michiganensis are host specific, the potential for nonoccupational, 

nondietary exposures (i.e., dermal and inhalation exposures) to these bacteriophages by the 

general population, including infants and children, is highly unlikely. Moreover, the general 

population, including infants and children, are exposed to bacteriophages daily in food and 

drinking water with no known adverse effects ever being reported. Additionally, all proposed 

uses occur in distinctly agricultural or commercial settings, and there are no proposed uses for 

residential areas. The Agency concludes, therefore, that in the unlikely event there is 

nonoccupational, nondietary exposure to those specific bacteriophages, such exposures would 

pose no risks to the general population, including infants and children. Nonoccupational

exposure is not expected for bacteriophage of Clavibacter michiganensis subsp. michiganensis as 

all proposed uses occur in distinctly agricultural or commercial settings, and there are no 

proposed uses for residential areas. 

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 exemption, EPA consider “available information concerning the 

cumulative effects of [a particular pesticide’s] ... residues and other substances that have a 

common mechanism of toxicity.”

EPA has not found bacteriophage of Clavibacter michiganensis subsp. michiganensis to share a 

common mechanism of toxicity with any other substances, and each bacteriophage isolate added 

to the AgriPhage CMM library is tested for ability to infect closely related bacteria. Inability to 

infect bacteria outside the genus Clavibacter is important to prevent passage of toxic or 

pathogenic genes to other bacteria by the bacteriophage. The registrant has in place limitations 

for bacteriophage hosts, namely use of only non-toxigenic Clavibacter michiganensis subspecies 

michiganensis (an obligate plant associated bacterium infecting tomatoes) to produce phage, and 

use of only lytic (and not lysogenic)1 bacteriophage, giving further assurance that toxin 

production would not even be carried as a trait by these bacteriophage. For the purposes of this 
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tolerance action, therefore, EPA has assumed that bacteriophage Clavibacter michiganensis

_______________________________________________

1

Lytic bacteriphages only multiply and kill their host bacterium by cell lysis at the end of their life cycle. Lysogenic bacteriophages 

can multiply via the lytic cycle, but usually enter a quiescent state in the host bacterium, and integrate their DNA into the host’s DNA. The 

host harboring the bacteriophage DNA is not affected by the presence of the bacteriophage’s DNA. When the infected bacterium undergoes 

normal cell division, the bacteriophage genes are replicated along with the host’s, and are passed on to the bacterial “daughter” cells. If the 

bacteriophage begins to replicate, and brings into its DNA any genes encoding toxins or pathogens, the lysogenic-type bacteriophage can 

transmit those genes to other similar host bacteria that otherwise would not produce the toxins or pathogenic substances.

subsp. michiganensis does not have a common mechanism of toxicity with other substances. For 

information regarding EPA’s efforts to determine which chemicals have a common mechanism 

of toxicity and to evaluate the cumulative effects of such chemicals, see EPA’s website at 

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

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

FFDCA section 408(b)(2)(C) provides that 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 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 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 FQPA Safety Factor. In applying this provision, EPA either retains 

the default value of 10X or uses a different additional safety factor when reliable data available 

to EPA support the choice of a different factor.

Based on the acute toxicity and pathogenicity data waiver rationales summarized in section 

IV(B)(1)(a) and Table 3 in Appendix A, 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 the residues of bacteriophage of Clavibacter michiganensis subsp. michiganensis.

This includes all anticipated dietary exposures and all other exposures for which there is reliable 

information. EPA has arrived at this conclusion because the information available on 

bacteriophage of Clavibacter michiganensis subsp. michiganensis does not demonstrate toxic, 

pathogenic, and/or infective potential to mammals. Thus, there are no threshold effects of 

concern and, as a result, the provision requiring an additional margin of safety does not apply. 

3. Occupational Exposure and Risk Characterization

Handler exposure to bacteriophage of Clavibacter michiganensis subsp. michiganensis is not 

expected to pose any undue risk, but appropriate personal protective equipment and 

precautionary statements are required on pesticide product labels to mitigate any potential risks 

to pesticide handlers due to prolonged or numerous exposures. Handlers applying bacteriophage 

of Clavibacter michiganensis subsp. michiganensis end-use products in commercial and 

agricultural settings must wear a long-sleeved shirt, long pants, socks, shoes, waterproof gloves, 

and a dust/mist filtering respirator meeting NIOSH standards of at least N-95, R-95, or P-95. 

Additional PPE, other than the standard described above, may be required on a product-specific 

basis.
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4. Human Health Risk Characterization

EPA considered human exposure to bacteriophage of Clavibacter michiganensis subsp. 

michiganensis 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 when bacteriophage of 

Clavibacter michiganensis subsp. michiganensis pesticide products are used in accordance with 

EPA-approved labeling.

C. Environmental Assessment (40 CFR § 158.2150)

The data waiver rationales, submitted by the applicant to support the pesticide products 

containing bacteriophage of Clavibacter michiganensis subsp. michiganensis, are sufficient to 

fulfill the Tier I 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 for 

the current uses and application methods. EPA has performed an environmental risk assessment 

based on the data waiver rationales provided by the applicant and has determined that the 

proposed use of bacteriophage of Clavibacter michiganensis subsp. michiganensis does not pose 

significant risk to nontarget organisms when used according to label directions. 

For a comprehensive summary of the generic data requirements described in sections IV(C)(1), 

refer to Table 4 in Appendix A.

1. Ecological Exposure and Risk Characterization 

Since bacteriophage are not capable of infecting eukaryotic cells, it is reasonable to expect those 

bacteriophage are also not capable of causing infection in eukaryotic organisms. Nontarget 

bacteria are unlikely to be adversely affected, since individual bacteriophage typically have a 

limited host range. Additionally, the applicant has a testing program to ensure pesticidal 

bacteriophage do not have a broad host range. Bacteriophages are ubiquitous in the environment, 

and nontarget organisms are regularly exposed directly to bacteriophage with no adverse effects 

reported in the published scientific literature. Bacteriophages may contain genes for substances 

that may be toxic to nontarget organisms; however, they are incapable of producing toxins 

outside of their host bacteria, since they consist solely of genetic material encapsulated in a 

protein envelope and do not have the metabolic processes required for toxin production. The 

applicant has in place limitations for the bacterial hosts, namely use of only nontoxigenic 

Clavibacter michiganensis to produce the bacteriophage and use of only lytic (and not lysogenic) 

bacteriophage, giving further assurance that toxin production would not even be carried as a trait 

by these bacteriophage. Based on the narrow host range of bacteriophage of Clavibacter 

michiganensis subsp. michiganensis to certain bacterial species, as well as the biological 

properties of bacteriophage in general, they are not expected to pose any hazard to nontarget 

terrestrial or aquatic organisms.

2. Environmental Fate Data 

As the information provided for the current uses and application methods is sufficient to both

satisfy the Tier I nontarget organism data requirements and for nontarget organism risk 

assessment for bacteriophage of Clavibacter michiganensis subsp. michiganensis, further testing 

at higher tier levels (i.e., Tiers II, III, and IV) is not required. 
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3. Threatened and Endangered Species Assessment

EPA has determined that adverse effects will not occur to nontarget organisms as a result of the 

proposed labeled applications of bacteriophage of Clavibacter michiganensis subsp. 

michiganensis. 

Since EPA has determined that no effects are anticipated for any nontarget species exposed to

bacteriophage of Clavibacter michiganensis subsp. michiganensis as a result of the proposed 

labeled applications, effects to federally listed, threatened and endangered species and their 

designated critical habitats are also not expected. Therefore, a “No Effect” determination is made 

for direct and indirect effects to listed species and their designated critical habitats resulting from 

the proposed uses of bacteriophage of Clavibacter michiganensis subsp. michiganensis, as 

labeled.

V. ENVIRONMENTAL JUSTICE

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. EPA has this goal for all communities and persons 

across the United States. 

To help address potential environmental justice issues, 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 bacteriophage of Clavibacter michiganensis

subsp. michiganensis, 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 EPA’s web site at 

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

VI. RISK MANAGEMENT DECISION

Pursuant to Section 3(c)(5) of FIFRA, EPA may register 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;
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(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.

With respect to criterion 1, the proposed pesticide product containing bacteriophage of

Clavibacter michiganensis subsp. michiganensis has well-known properties. EPA has no 

knowledge that would contradict the claims made on the AgriPhage CMM label, and the 

pesticide product is not expected to cause unreasonable adverse effects on the environment when 

used according to the label instructions. Regarding criterion 2, the current product label, as well 

as the data and information presented in this document, comply with the requirements of FIFRA. 

It is believed that bacteriophage Clavibacter michiganensis subsp. michiganensis pesticide 

product will not cause any unreasonable adverse effects on the environment, and AgriPhage 

CMM is likely to provide protection against bacterial canker disease on tomatoes as claimed, 

thus satisfying criterion 3. Criterion 4 is satisfied in that bacteriophage Clavibacter 

michiganensis subsp. michiganensis pesticide product is not expected to cause unreasonable 

adverse effects when used according to label instructions. AgriPhage CMM, containing 

bacteriophage of Clavibacter michiganensis subsp. michiganensis as a new active ingredient, is

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

VII. ACTIONS REQUIRED BY THE REGISTRANT

A. Final Printed Labeling

Before releasing AgriPhage CMM for shipment, the registrant is required to provide appropriate 

final printed labeling to EPA.

B. Terms of Registration

EPA has determined the following terms must be met for the registration of bacteriophage of 

Clavibacter michiganensis subsp. michiganensis as a new microbial active ingredient. 

1. Deposition of a sample of bacteriophage of Clavibacter michiganensis subsp. 

michiganensis into a nationally recognized culture collection (40 CFR 158.2120). The 

sample should be deposited under a maintenance agreement so that there is no chance the 

culture collection will discard it. The sample must remain on deposit as long as the 

registration is maintained. The Budapest Treaty on the International Recognition of the 

Deposit of Microorganisms for the Purposes of Patent Procedure (available from the 

World Intellectual Property Organization at http://www.wipo.int) provides information 

on what constitutes a “recognized” culture collection that would provide assurance for 

maintenance of a culture deposit.

2. A new Storage Stability Study (OCSPP 830.6317) of bacteriophage of Clavibacter 

michiganensis subsp. michiganensis must be submitted within one (1) year of registration 

to support the labeled viability claim of the product. The original storage stability study 

submitted was found to be ACCEPTABLE, but a substantial decline of PFU/mL occurred 

after the first 120 days of the study. The new study will verify the viability claim of the 

product.
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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 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 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 EPA under the 

provisions of 40 CFR § 158.2140(d).
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VIII. GLOSSARY OF ACRONYMS AND ABBREVIATIONS

BPPD Biopesticides and Pollution Prevention Division

BRAD Biopesticides Registration Action Document

CFR Code of Federal Regulations

cP centipoise

EDSP Endocrine Disruptor Screening Program

EP end-use product

EPA Environmental Protection Agency (the “Agency”)

FFDCA Federal Food, Drug, and Cosmetic Act

FIFRA Federal Insecticide, Fungicide, and Rodenticide Act

FQPA Food Quality Protection Act

FR Federal Register

g/mL gram per milliliter

MP manufacturing-use product

MRID No. Master Record Identification Number

NIOSH National Institute for Occupational Safety and Health

OCSPP Office of Chemical Safety and Pollution Prevention

OPP Office of Pesticide Programs

PC Code Pesticide Chemical Code

PFU Plaque Forming Unit

PP Pesticide Petition

PPE personal protective equipment

TGAI technical grade of the active ingredient
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IX. BIBLIOGRAPHY

A. Studies Submitted to Support the AgriPhage CMM Pesticide Product Registration

MRIDNo. Study Title

47720400 Interregional Research Project No. 4 (2009) Submission of Product 

Chemistry, Toxicity, and Residue Data in Support of the Application for 

Registration of Agriphage CMM, and the Petition for Tolerance of 

Bacteriophage of Clavibacter michiganensis subsp. michiganensis for 

Use on Tomatoes. Transmittal of 3 Studies.

47720401 Walbeck, A. (2009) Product Chemistry: Bacteriophage of Clavibacter 

michiganensis subsp. michiganensis - AgriPhage CMM. Project Number: 

0430B. Unpublished study prepared by OmniLytics, Inc. 295 p.

47720402 Walbeck, A.; Braverman, M. (2009) Rationale for Waiver of Toxicity 

and Residue Data Requirements: Bacteriophage of Clavibacter 

michiganensis subsp. michiganensis - AgriPhage CMM. Project Number: 

0430B. Unpublished study prepared by OmniLytics, Inc. 175 p.

47720403 Walbeck, A.; Braverman, M. (2009) Rationale for Waiver of Non Target 

Organism Testing Requirements: Bacteriophage of Clavibacter 

michiganensis subsp. michiganensis - AgriPhage CMM. Project Number: 

0430B. Unpublished study prepared by OmniLytics, Inc. 169 p.

48053600 Omnilytics, Inc. (2010) Submission of Product Chemistry Data in 

Support of the Application for Registration of AgriPhage CMM. 

Transmittal of 1 Study.

48053601 Blum, K. (2010) Product Analysis Test Guidelines: AgriPhage-CMM. 

Project Number: IR/4/PR/0430B. Unpublished study prepared by 

Omnilytics, Inc. 335 p.

48383100 OmniLytics, Inc. (2011) Submission of Product Chemistry Data in 

Support of the Application for Registration of AgriPhage CMM. 

Transmittal of 1 Study.

48383101 Blum, K. (2010) Product Analysis Test Guidelines: AgriPhage-CMM. 

Project Number: IR/4/PR/430B. Unpublished study prepared by 

OmniLytics, Inc. 327 p.

B. Environmental Protection Agency and Pest Management Regulatory Agency Risk 

Assessment Memoranda

PMRA. 2011a. Avian Oral; Avian Pulmonary, Inhalation or Injection; Fish: Freshwater; 

Arthropods: Terrestrial; Arthropods: Aquatic; Non-Arthropod invertebrates: Terrestrial; 

Non-Arthropod invertebrates: Aquatic; Plants: Terrestrial; Plants: Aquatic ─ Waiver 

Request Sub. No. 2009-1066/ OmniLytics Inc. [OMT] Lytic bacteriophage of 

Clavibacter michiganensis subsp. michiganensis [TOM]. Data Evaluation Record from J. 

Ptasinski signed March 25, 2010 and J.V. Gagliardi signed June 2, 2011.
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U.S. EPA. 2011b. Bacteriophage of Clavibacter michiganensis subsp. michiganensis –

AgriPhage CMM. Memorandum from J.V. Gagliardi, Ph.D. and J. Ptasinski to A. Gross

dated May 25, 2011.

U.S. EPA. 2011c. Human Health and Environmental Risk Assessment of Bacteriophage of 

Clavibacter michiganensis subsp. michiganensis (PC Code: 228983). Memorandum from 

J.V. Gagliardi to A. Gross dated June 30, 2011.
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APPENDIX A. MICROBIAL PESTICIDES DATA REQUIREMENTS 

(40 CFR PART 158 – SUBPART V)

TABLE 1. Product Analysis Data Requirements for Bacteriophage of Clavibacter michiganensis subsp. michiganensis, 

AgriPhage CMM (40 CFR § 158.2120)

OCSPP 

Guideline 

Number 

Data Requirement Results MRID No.

885.1100 Product Identity Submitted data fulfill the requirement for product identity. 477204-01

480536-01

483831-01

885.1200 Manufacturing Process Submitted data fulfill the requirement for manufacturing 

process.

477204-01

480536-01

483831-01

Not applicable Deposition of a Sample 

in a Nationally 

Recognized Culture 

Collection

Not applicable- Enforcement Analytical Method was 

conducted in lieu of Depositing a Sample in a Nationally 

Recognized Culture Collection

885.1300 Discussion of Formation 

of Unintentional 

Ingredients

Submitted data fulfill the requirement for discussion of 

formation of unintentional ingredients.

477204-01

480536-01

483831-01

885.1400 Analysis of Samples Submitted data fulfill the requirement for analysis of samples. 477204-01

480536-01

483831-01

885.1500 Certification of Limits Limits listed on the confidential statement of formula are 

adequate/acceptable.

Additional Studies

830.1800 Enforcement Analytical 

Method

Submitted data fulfill the requirement for an enforcement 

analytical method.

477204-01

480536-01

483831-01

TABLE 2. Physical and Chemical Characteristics for Bacteriophage of Clavibacter michiganensis subsp. michiganensis, 

AgriPhage CMM (40 CFR § 158.2120)

OCSPP 

Guideline 

Number 

Data Requirement Results MRID No.

830.6302 Color Golden Yellow 477204-01

830.6303 Physical State Liquid 477204-01

830.6304 Odor None to slight 477204-01

830.6313 Stability to Normal and 

Elevated

Temperatures, Metals,

and Metal Ions

Not applicable 477204-01

830.6317 Storage Stability At least one year at 4°C 477204-01

830.6319 Miscibility Completely miscible in water 477204-01

830.6320 Corrosion 

Characteristics

Not corrosive 477204-01

830.7000 pH 5.3-6.2 477204-01

830.7100 Viscosity 0.90 cP at 21°C 477204-01

830.7300 Density/Relative 

Density/Bulk Density 

(Specific Gravity)

1.002-1.006 g/mL 477204-01
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TABLE 3. Toxicology Data Requirements for AgriPhage CMM (40 CFR § 158.2140)

OCSPP Guideline 

Number

Data Requirement ResultsMRID No.

Tier I

885.3050 Acute Oral 

Toxicity/Pathogenicity Waived given that bacteriophage are viruses that only infect 

specific bacteria. Bacteriophage are present in high numbers in 

the environment and non-polluted waters and there have been no 

reports of adverse effects from exposure.

Classification: Acceptable

477204-02 885.3150 Acute Pulmonary 

Toxicity/Pathogenicity

885.3200 Acute Injection 

Toxicity/Pathogenicity 

(Intravenous)

885.3400 Hypersensitivity 

Incidents

No hypersensitivity incidents, including immediate-type or 

delayed-type reactions of humans and domestic animals that 

occurred during research, development, or testing of the 

AgriPhage CMM, were reported by the applicant. Any future 

hypersensitivity incidents must be reported per OCSPP Guideline 

885.3400. 

885.3500 Cell Culture

Waived given that bacteriophage are viruses that only infect 

specific bacteria. Bacteriophage are present in high numbers in 

the environment and non-polluted waters and there have been no 

reports of adverse effects from exposure. 

Classification: Acceptable

477204-02

870.1100 Acute Oral Toxicity

870.1200 Acute Dermal Toxicity

870.1300 Acute Inhalation 

Toxicity

870.2400 Acute Eye Irritation

Tiers II and III

Not required for bacteriophage of Clavibacter michiganensis subsp. michiganensis based on the lack of acute 

toxicity/pathogenicity in the Tier I data waiver rationale.

TABLE 4. Nontarget Organism Toxicity and Environmental Fate Data Requirements for Bacteriophage of Clavibacter 

michiganensis subsp. michiganensis, AgriPhage CMM (40 CFR § 158.2150)

OCSPP Guideline 

Number

Data Requirement Results MRID No.

Tier I

885.4050 Avian Oral Toxicity

Waived based on the fact that, since bacteriophage 

are not capable of infecting eukaryotic cells, it is 

reasonable to expect that bacteriophage are also not 

capable of causing infection in eukaryotic organisms. 

Nontarget bacteria are unlikely to be adversely 

affected since individual bacteriophage typically 

have a limited host range amongst bacteria and it is 

uncommon for a bacteriophage to be able to infect 

outside of a bacterial species. Additionally, the 

registrant has a testing program to ensure pesticidal 

bacteriophage do not have a broad host range. 

Classification: Acceptable

477204-03

885.4100 Avian Inhalation 

Toxicity/Pathogenicity

885.4150 Wild Mammal 

Toxicity/Pathogenicity

885.4200 Freshwater Fish 

Toxicity/Pathogenicity

885.4240 Freshwater Invertebrate 

Toxicity/Pathogenicity

885.4280 Estuarine/Marine Fish and 

Invertebrate Testing

885.4300 Nontarget Plant Testing

885.4340 Nontarget Insect Testing

885.4380 Honey Bee Testing

Tiers II, III, and IV

Not required for bacteriophage of Clavibacter michiganensis subsp. michiganensis based on the current uses and application 

methods.
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APPENDIX B. PESTICIDE PRODUCTS

EPA File 

Symbol 

Registration 

Name

Percentage 

Active 

Ingredient

Formulation 

Type

Use Site(s) Method(s) of 

Application

Application 

Rate

Target 

Pest

67986-A AgriPhage 

CMM

0.0005% End Use Tomato Seedling

Treatment

(4 leaf stage)

(Foliar Spray 

or 

Hydroponic)

1 pint of 

AgriPhage 

CMM/9600 

sq. ft. 

greenhouse 

space

Bacterial 

Canker 

Disease

Hydroponic 

Greenhouse 

Treatment

2 to 4 quarts 

of AgriphageCMM/100 

gallons of 

water per acre

Field 

Treatment

(Foliar Spray)

1-2 pints of 

AgriPhage 

CMM/100 

gallons of 

water/acre for 

field 

applications