# BIOPESTICIDES REGISTRATION ACTION DOCUMENT

Phoma macrostoma strain 94-44B



# DRAFT DOCUMENT

U.S. E NVIRONMENTAL 

## P ROTECTION 

## A GENCY 

## O FFICE OF 

## P ESTICIDE 

## P ROGRAMS 

## B IOPESTICIDES AND 

## P OLLUTION 

## P REVENTION 

## D IVISION

November 30, 2011

## T ABLE OF 

## C ONTENTS

ACRONYMS ...................................................................................................................... ................................ 4 EXECUTIVE SUMMARY ............................................................................................................. ........................ 7



### I. R EGULATORY 

### B ACKGROUND 

### .................................................................................................................... 8 A. Application for Pe sticide Registration .................................................................................... ................. 8 B. North American Free Tr ade Agreement Joint Re view........................................................................... .. 8 C. Public Pa rticipation ...................................................................................................... ............................ 8 

### II. B IOLOGICAL 

### C ONSIDERATIONS 

### ................................................................................................................ 9 III. A CTIVE 

### I NGREDIENT 

### C HARACTERIZATION 

### ................................................................................................ 10 A. Product Chemistr y and Composition ......................................................................................... ........... 10 1. Product Identity .......................................................................................................... .................... 10 2. Manufactu ring Proc ess ..................................................................................................... .............. 10 3. Deposition of a Sample in a Nati onally Recognized Cu lture Collection .......................................... 11 4. Discussion of Unin tentional Ingredients ................................................................................... ...... 11 B. Analysis and Certified Limits.............................................................................................. .................... 11 1. Analysis of Samp les ....................................................................................................... .................. 11 2. Certification of Limits ................................................................................................... ................... 11 C. Physical and Ch emical Prop erties .......................................................................................... ................ 11 

### IV. H UMAN 

### H EALTH 

### R ISK 

### A SSESSMENT 

### ...................................................................................................... 12 A. Toxicity .................................................................................................................. ................................ 12 1. Acute Toxicity ............................................................................................................ ...................... 12 2. Endocrin e Effects ......................................................................................................... ................... 13 B. Exposure .................................................................................................................. .............................. 14 1. Occupation al Expo sure ..................................................................................................... .............. 14 2. Residential, School, and Day Care Exposure ................................................................................ ... 15 C. Human Health Risk Characterization ........................................................................................ ............. 15 

### V. E COLOGICAL 

### R ISK 

### A SSESSMENT AND 

### E NDANGERED 

### S PECIES 

### A SSESSMENT 

### ....................................................... 15 A. Ecological Risk Asse ssment ................................................................................................ ................... 15 1. Effects of Phoma macrostoma strain 94-44B to Nontarget Organisms (Ecotoxicity) ..................... 16 2. Environm ental Fate ........................................................................................................ ................. 17 3. Environmental Risk Characterization ....................................................................................... ....... 17 B. Threatened and Endang ered Species Assessment .............................................................................. .. 18 1. Direct Effects ............................................................................................................ ....................... 18 2. Indirect Effects and E ffects to Critic al Habi tat .......................................................................... ...... 18 

### VI. R ISK 

### M ANAGEMENT 

### .......................................................................................................................... 19 A. Risk Mitigation ........................................................................................................... ............................ 19 1. General ................................................................................................................... ......................... 19 2. Enviro nmental ............................................................................................................. .................... 19 B. Future Changes to the Use Pattern ......................................................................................... .............. 19 

### VII. R EGISTRATION 

### E LIGIBILITY 

### D ETERMINATION 

### ........................................................................................... 19 A. Decision .................................................................................................................. ............................... 19 B. Terms of th e Registration ................................................................................................. ..................... 20 

### VIII. E NVIRONMENTAL 

### J USTICE 

### ................................................................................................................. 20

BIBLIOGRAPHY .................................................................................................................. ............................. 21

### - 3- 

## BRAD T EAM 

## Office of Pesticide Programs Biopesticides and Pollution Prevention Division Microbial Pesticides Branch

Science Review Joel Gagliardi, Ph.D. Product Analysis and Human Health Risk Shannon Borges, M.S. Environmental and Ecological Risk Gail Tomimatsu, Ph.D. Secondary Review of Environmental and Ecological Risk

Regulatory Kathleen Martin, M.S.E.S. Regulatory Action Leader Sheryl Reilly, Ph.D. Chief, Microbial Pesticides Branch

### - 4- 

## A CRONYMS

♀ Female ♂ Male
a.i. Active Ingredient
AAFC Agriculture and Agri-Food Canada

AFLP Amplified Fragment Length Polymorphism
APHIS USDA’s Animal and Plant Health Inspection Service
ASTM American Society for Testing and Materials
bw Body Weight
CD ® A strain of laboratory rat from Charles River; it originated from work by Robert Dawley.
CFR Code of Federal Regulations
CFU Colony Forming Unit CFU/g CFUs per gram CFU/kg CFU per kg of body weight per day bw day
CFU/mL CFUs per milliliter

cm centimeter

cm 2 Centimeters squared; a measure of surface area.

DNA Deoxyribonucleic acid
EC 50 Effective concentration
EDSP Endocrine Disruptor Screening Program

EPA U.S. Environmental Protection Agency or, the Agency
FFDCA Federal Food, Drug, and Cosmetic Act

FIFRA Federal Insecticide, Fungicide, and Rodenticide Act

FR Federal Register
FWS The U.S. Fish and Wildlife Service

g gram
GPO Government Printing Office i.p. Intraperitoneal
IDAC The International Depositary Authority of Canada
ITS Internal Transcribed Spacer kg kilogram
LC 50 Median Lethal Concentration

LD 50 Median Lethal Dose

mg milligram mph miles per hour

MRID Master Record IDentification (number)

NA Not Applicable

NAFTA North American Free Trade Agreement
NOAEC No-observed-adverse-effectconcentration
NOR Notice of Receipt
OPP EPA’s Office of Pesticide Programs

P. Phoma macrostoma macrostoma
PC Code Pesticide Chemical Code: a six-digit number assigned by OPP to identify pesticide chemicals.
PCR Polymerase Chain Reaction
PFGE Pulsed Field Gel Electrophoresis

PMRA Health Canada’s Pest Management Regulatory Agency

PPE Personal Protective Equipment
PPQ Plant Protection and Quarantine

RAPD Random Amplification of Polymorphic DNA

rDNA Ribosomal DNA
TGAI Technical grade active ingredient
U.S. United States
USDA U.S. Department of Agriculture
WPS Worker Protection StandardP. macrostoma strain 94-44B page 7 Biopesticides Registration Action Document



## DRAFT DOCUMENT E XECUTIVE 

## S UMMARY



### Phoma macrostoma strain 94-44B is a newly developed bioherbicide that will be used to control pre- and post-emergent broadleaf weeds such as dandelion on ornamental plants and turf. Phoma macrostoma is a fungus; strain 94-44B was found along a roadway in Saskatchewan, Canada, on di seased Canada thistle.

In 2010, the Scotts Company applied to Health Canada’s Pest Management Regulatory Agency (PMRA) and the U.S. Environmental Pr otection Agency’s (EPA) Office of Pesticide Programs for registration of products containing th is new active ingredient. Under the purview of the North American Free Trade Agreement, Sco tts requested that the review be conducted jointly between the two countries. In Novem ber 2011, PMRA conditi onally registered five products containing P. macrostoma strain 94-44B. A summary of their Evaluation Report (document number ERC 2011-09) can be found at: www.hc-sc.gc.ca/cpsspc/pubs/pest/_decisions/erc2011- 09/index-eng.php. EPA intends to register three products containing P. macrostoma strain 94-44B as the active ingredient—one manufacturing- and two-end products.

Human Health . EPA has determined that use of th is new bioherbicide will not cause unreasonable adverse effects to human health or the environment. The ac ute toxicity of P. macrostoma strain 94-44B is low. In acute toxicity testing, P. macrostoma strain 94-44B was not toxic via any route. The Acute Toxi city Category for oral, inhalation, and dermal exposure is IV (see 40 CFR 156.62 fo r a description of the Categories). P. macrostoma strain 94-44B is slightly irritating to the eyes (Toxicit y Category III) and is not a skin irritant (Toxicity Category IV).

Environment . EPA does not expect adverse effect s to birds; wild mammals; insects; honey bees; freshwater fish and invertebrates; marine/estuari ne fish and invertebrates; and aquatic plants. Effects to nontarget plants bey ond the treated sites are expected to be limited to immediately adjacent areas for applications to turf and ornamental s, and effects will be limited to more highly susceptible species. Some species of nontarget plants may be adversely affected where significant exposure o ccurs; however, environmental fate data show that P. macrostoma strain 94-44B is unlikely to persist at high levels for long periods of time.

Threatened and Endangered Species . Under the Endangered Species Act of 1973, EPA has made a no effect determination for the use of pesticide products containing P. macrostoma strain 94-44B as an active ingredient. The U.S. Fish and Wildlife Service defines the term ‘no effect’ to mean that “its proposed action will not affect a listed species or designated critical habitat.” EPA’s no effect findi ng is based on the lack of adverse effects to terrestrial vertebrates, nontarget insects, and freshwater and marine/estuarine animals and plants.P. macrostoma strain 94-44B page 8 Biopesticides Registration Action Document



## DRAFT DOCUMENT Phoma macrostoma strain 94-44B (PC Code 080303) is a fungus that has been developed as a bioherbicide to control pre- and post-emergent broadleaf weeds such as dandelion (AAFC 2009). The isolate P. macrostoma strain 94-44B was found in Saskatchewan, Canada, on diseased Canada thistle. In October 2009, the Scotts Company applied to the U.S. Environmental Protection Agency (EPA or the Agency) for registration of three products (one manufacturing- and two end-use) containing this new active ingredient (a.i.). Provided below is a summary of the products.

Phoma Tech Phoma H Phoma P File Symbol 239–ETNE 239–ETNG 239–ETNU % a.i. 92% 92% 92%

a CFU/g 1 × 10 3 1 × 10 3 1 × 10 3 Proposed Uses Formulation of herbicides intended for terrestrial, nonfood uses. Residential, to control weeds in or around flower beds and roses, shrubs, trees, ornamental grasses, and turf. Commercial and agricultural, to control weeds in ornamental plants (flowers and roses, ground covers, shrubs, and trees), ornamental grasses,

turfgrass (including seed

starting applications),

field-grown nursery plants, landscapes, and container plants.

a CFU=colony forming unit.

I. REGULATORY BACKGROUND A. Application for Pesticide Registration . A Notice of Receipt (NOR), announcing EPA’s receipt of Scotts’ application to register pesticide products containing P. macrostoma strain 94-44B, was published in the Federal Register on March 10, 2010 (75 FR 11175); no comments were received. This notice is available through the Government Printing Office’s (GPO) Federal Register web page: www.gpoaccess.gov/fr/retrieve.html (note: select the 2010 radio button; the page number is 11176).

B. North American Free Trade Agreement Joint Review

. P. macrostoma strain 94-44B was the subject of a North American Free Trade Agreement (NAFTA) joint registration review conducted by EPA’s Office of Pesticide Programs (OPP) and Health Canada’s Pest Management Regulatory Agency (PMRA). PMRA has conditionally registered five products containing P. macrostoma strain 94-44B as the active ingredient. A summary of PMRA’s Evaluation Report (document number ERC2011- 09) can be found at: www.hc-sc.gc.ca/cpsspc/pubs/pest/_decisions/erc2011-09/index-eng.php.

C. Public Participation . 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 new policy, the Agency provides a public comment period prior to making a registration decision for (at minimum): new active ingredients; first food uses; first outdoor uses; first residential uses; and any other registration decisions for which the Agency believes there may be substantial public interest.
Consistent with this new policy of making registration actions more transparent, P. macrostoma strain 94-44B is subject to a 30-day comment period as a ‘new active ingredient’ whose registration would result in ‘first outdoor uses’ and ‘first residential uses.’ The public comment period runs from December 1, 2011 to December 31, 2011. To submit a comment, see the instructions at EPA’s webpage titled, “Instructions for Commenting During Open Comment Periods” (www.epa. gov/pesticides/regulating/comment-P. macrostoma strain 94-44B page 9 Biopesticides Registration Action Document



## DRAFT DOCUMENT instruction.html). The “Docket Folder Summary” for this action is accessed through regulations.gov; the docket number is EPA-HQ-OPP-2010-0094 (note: under “Enter Keyword or ID” enter the docket number).

II. BIOLOGICAL CONSIDERATIONS (MRID 479150-01). Phoma macrostoma is a fungus of the class Coelomycetes. It is commonly isolated from woody plants and, is found incidentally on other plants, in soil, and leaf litter. In the United States, it has been isolated from plants (mainly trees). Countries where P. macrostoma is found include:

▪ Africa (Egypt, Ethiopia, Kenya, Nigeria, Tanzania, and Zimbabwe);

▪ Asia (Hong Kong, India, Nepal, Pakistan, and Sri Lanka);

▪ Canada (Alberta, New Brunswick, Nova Scotia, Ontario, and Saskatchewan);

▪ Europe (Bulgaria, Cyprus, France, Germany, Italy, Netherlands, Sweden, and Turkey) and the

United Kingdom;

▪ New Zealand;

▪ United States (Alabama, Arkansas, Florida, G eorgia, Illinois, Indiana, Minnesota, Mississippi,

Missouri, New Jersey, North Carolina, Oklahoma, Virginia, Washington, West Virginia, Wisconsin, and the Northeast); and

▪ Venezuela.
In the contiguous United States, P. macrostoma has not been reported as a widely prevalent 1 phytopathogen (Georgia 2011), although, several species in the Phoma genus are considered to be relevant phytopathogens. While P. macrostoma is generally regarded as a weak pathogen or wound parasite, there are numerous reports of P. macrostoma causing primary disease in plants. Many species of Phoma exist as saprobes 2 in the absence of suitable host plants, but will switch to a pathogenic existence if a suitable host plant is encountered (Aveskamp et el. 2008). A host list for P. macrostoma is available in Boerema and Dorenbosch (1970) and Farr and Rossman (2011). The applicant has also provided a list of susceptible plants for P. macrostoma strain 94-44B; it is in the Agency’s Environmental Risk Assessment (U.S. EPA 2011c).

P. macrostoma strain 94-44B was initially isolated from diseased Canada thistle ( Cirsium

arvense L.), along a roadway in Melfort, Saskatchewan; it has been developed as a microbial pesticide for broadleaf weeds in turf and ornamentals. Effects on broadleaf plants include chlorotic leaf spots, necrosis, and severe bleaching of emerging leaves. These effects can be lethal, although treated plants recover in some cases. The herbicidal action is considered bimodal because the fungal mycelia infect plant root systems and produce phytotoxic macrocidins; the macrocidins then cause foliar chlorosis and bleaching (Bailey et al. 2010).
Taxonomy . The taxonomic designation of Phoma macrostoma is:

K INGDOM : Fungi O RDER : Sphaeropsidales
D IVISION : Eumycota G ENUS : Phoma S UBDIVISION : Deuteromycotina S PECIES : macrostoma Montagne C LASS : Coelomycetes V ARIETY ( VAR .): macrostoma

1 A ‘widely prevalent’ organism is one that: might be identified by an experienced fa rmer; would be able to be identified by most experienced county extension agents; would be able to be id entified by all experienced diagnos ticians at the state level; would raise no new regulatory concerns at th e state or federal level if it was identified; and is widely distributed in any gi ven five year period in the state where t he host plant(s) is grown (Georgia 2010).
2 A saprobe is an organism that exists on nonliving organic matter.P. macrostoma strain 94-44B page 10 Biopesticides Registration Action Document



## DRAFT DOCUMENT Morphological Description . The pycnidia (asexual fruiting bodies) are spherical to irregular in shape with one or two relatively wide ostioles (small openings or pores from where spores are released from the fruiting bodies). The conidial matrix is salmon to fles h colored. Colonies grown on oatmeal agar are 4.5 to 6 cm after seven days and are sienna to red-wine in color.

Growth . Scotts reported that P. macrostoma strain 94-44B grows best at a temperature between 20 to 25 °C (68 to 77°F); however, it will grow in the 10 to 30 ° C (50 to 86 ° F) temperature range. Minimal or no growth occurs below 5 ° C (41 ° F) or above 35 ° C (95 ° F). (MRID 479150-26)

P. macrostoma as a Biopesticide

. P. macrostoma is a fungus and when not reproducing, it exists as a spore. Under the right conditions (e.g., a certain temperature, humidity), the spores will start to reproduce (germinate) and form mycelia. P. macrostoma strain 94-44B’s pesticidal activity arises from the action of macrocidins, which are produced by the mycelia, either in vitro or in situ (Bailey et al. 2011b). As a pesticide product, P. macrostoma may be active as either a ‘heat-killed’ product or as a viable product, with mycelia fragments. With the heat-killed product, the macrocidins are taken up by plant roots to produce photobleaching, which results in chlorosis and plant mortality. When the viable product is applied to soil, the plant roots become infected, providing for direct delivery of the macrocidins into susceptible plants. Nonsusceptible plants may also become infected and take up macrocidins; however, the levels of P. macrostoma strain 94-44B are thought to decline over time, with no noticeable negative effects on the plants.

III. ACTIVE INGREDIENT CHARACTERIZATION (40 CFR 158.2120). Most of the product analysis data requirements have been met. Once production of these new, proposed pesticide products is underway, a final manufacturing process must be submitted (Guideline No 885.1200). Additionally, five-batch analyses need to be completed for all three products (Guideline No 885.1400), and three studies—stability to normal and elevated temperatures, metals and metal ions (Guideline No 830.6313); storage stability (Guideline No 830.6317); and corrosion characteristics (Guideline No 830.6320) are underway. EPA expects Scotts to submit the results of these studies when they are completed.

A. Product Chemistry and Composition 1. Product Identity (Guideline No 885.1100). The applicant adequately described the identity of P. macrostoma strain 94-44B, including how this particular strain is unique from other Phoma species (MRID 479150-01; 482810-01). A number of researchers have studied P. macrostoma strain 94-44B at the molecular level to differentiate it from other species of Phoma and P. macrostoma strains. Their testing includes 3 : RAPD PCR and DNA PFGE (Zhou et al. 2005); DNA-specific probe (Zhou et al. 2005); Primer-specific identification of biocontrol isolates; ITS rDNA sequence analysis; and AFLP fingerprinting; and genetic mating (Zhou et al. 2005). (MRID 479150-01)

2. Manufacturing Process (Guideline No 885.1200). A general description for design of a modular manufacturing facility is given; it is acceptable. Once production is underway, a final production method needs to be submitted along with five-batch analyses for the manufacturing and end-use products. (MRIDs 479150-01, 482810-01, 481451-01)

3 RAPD PCR=’Random Amplification of Polymorphic DNA’ ‘Pol ymerase Chain Reaction;’ DNA PFGE=’Deoxyribonucleic acid’ ‘Pulsed Field Gel Electrophoresis;’ ITS rDNA=’Internal Tr anscribed Spacer’ ‘Ribosomal DNA;’ AFLP=Amplified Fragment Length Polymorphism.P. macrostoma strain 94-44B page 11 Biopesticides Registration Action Document



## DRAFT DOCUMENT 3

. Deposition of a Sample in a Nationally Recognized Culture Collection (Guideline No 885.1200). The strain known as Phoma macrostoma strain 94-44B was deposited with the International Depositary Authority of Canada (IDAC), National Microbiology Laboratory, Public Health Agency of Canada. This accession number is IDAC-230201-3. (MRID 479150-01)

4. Discussion of Unintentional Ingredients (Guideline No 885.1300). In the fermentation and production of its P. macrostoma strain 94-44B pesticide products, Scotts is aware of stages in the manufacturing process where contamination and development of unintentional ingredients may o ccur. They have protocols in place to manage the introduction of human pathogens and manage any contaminated batches. (MRIDs 479150-01; 482810-01)

In the manufacture of P. macrostoma products, macrocidins are produced in the fermentation process. It is the macrocidins that contribute to the overall pesticidal activity of these new products.

B. Analysis and Certified Limits 1. Analysis of Samples (Guideline No 885.1400). Preliminary analyses have been conducted for the Phoma products. Once production is underway, a final production method needs to be submitted along with five-batch analyses for the manufacturing and end-use products. (MRID 479150-02; 481451-02).

2. Certification of Limits (Guideline No 885.1500). This requirement was adequately addressed. Under 40 CFR 158.350, the “applicant may propose a certified limit for an active or inert ingredient that differs from the standard certified limit....” Scotts proposed a limit wider than the standard for Phoma TECH, and their rationale was reasonable. (MRID 479150-02)

C. Physical and Chemical Properties . Provided in Table 1 is a summary of the physical and chemical properties of P. macrostoma strain 94-44B. With a few exceptions for ongoing studies (for example, Scotts has done preliminary work regarding the stability and corrosion potential of the Phoma products) all the physi cal and chemical property requirements have been met. (MRIDs 479150-03, 479145-01, and 479146-01)

Table 1 . Select Physical and Chemical Properties of Phoma macrostoma strain 94-44B D ATA R EQUIREMENT

( G UIDELINE No ) T EST S UBSTANCE V ALUE MRID C LASSIFICATION

Color (830.6302) TGAI a Brownish-gray Method : Munsell Color Chart; observation made

at room temperature. 479150-03 Acceptable

Phoma P Dark brown 479145-01 Acceptable
Phoma H Dark brown 479146-01 Acceptable

Physical state

(830.6303) TGAI Powder Method : Visual inspection at room temperature. 479150-03 Acceptable
Phoma P Granule 479145-01 Acceptable
Phoma H Granule 479146-01 Acceptable

Odor (830.6304) TGAI Earthy Method : Olfactory inspection at room temperature. 479150-03 Acceptable
Phoma P Earthy 479145-01 Acceptable
Phoma H Earthy 479146-01 AcceptableP. macrostoma strain 94-44B page 12 Biopesticides Registration Action Document



## DRAFT DOCUMENT D ATA R EQUIREMENT

( G UIDELINE No ) T EST S UBSTANCE V ALUE MRID C LASSIFICATION

Stability to normal and elevated temperatures, metals and metal ions (830.6313) TGAI In progress NA In progress; to be submitted

Storage stability (830.6317) TGAI Being studied in two container types. (MRID 479150-03) NA In progress; to be submitted

Phoma P Being studied in two container types. (MRID 479145-01) NA In progress; to be submitted

Phoma H Being studied in two container types. (MRID 479146-01) NA In progress; to be submitted

Miscibility (830.6319) “Only required for emulsifiable liquid forms of microbial pesticides” (40 CFR 158.2120). Phoma TECH, Phoma P, and Phoma H are solids.

Corrosion characteristics

(830.6320) TGAI Being studied in two container types. (MRID 479150-03) NA In progress; to be submitted

Phoma P Being studied in two container types. (MRID 479145-01) NA In progress; to be submitted

Phoma H Being studied in two container types. (MRID 479146-01) NA In progress; to be submitted

pH (830.7000) TGAI 5.53 Method : The pH of a 5% solution was measured using ASTM E-70 479150-03 Acceptable
Phoma P 5.28 479145-01 Acceptable
Phoma H 5.28 479146-01 Acceptable

Viscosity (830.7100) “Only required for liquid forms of microbial pesticides” (40 CFR 158.2120); Phoma TECH, Phoma P, and Phoma H are solids.

Bulk density (830.7300) TGAI 0.4 g/mL
Method : ASTM E-727 479150-03 Acceptable
Phoma P 0.7 g/mL 479145-01 Acceptable
Phoma H 0.7 g/mL 479146-01 Acceptable

a TGAI=technical grade active ingredient. b NA=Not applicable.

IV. HUMAN HEALTH RISK ASSESSMENT

. In assessing the risk of a pesticide to human health, EPA considers the toxicity of the pesticide in addition to exposure routes and levels. Provided in section A (below) is the toxicity of P. macrostoma strain 94-44B and in section B, the exposure. The Risk Characterization is provided in section C.

A. Toxicity (40 CFR 158.2140) 1. Acute Toxicity . Provided in Table 2 is a summary of the toxicity data for P. macrostoma strain 94-44B. All of the studies are acceptable.

Table 2. Summary of Submitted Toxicology Data for Phoma macrostoma strain 94-44B
R EQUIREMENT (G UIDELINE No ) MRID T OXICITY AND C LASSIFICATION a T OXICITY C ATEGORY Acute Oral Toxicity/ Pathogenicity (885.3050) 479150-05; 479150-08 ♂ and ♀ CD rats were given a si ngle oral dose (1.0 × 10 8 CFU/mL) of P. macrostoma strain 94-44B spores; it cleared by Day 7 and 21. C ONCLUSION : the test material was not toxic, infective nor pathogenic via the oral route.
b LD 50 (combined)>1 × 0 8 CFU per animal
C LASSIFICATION : Acceptable IVP. macrostoma strain 94-44B page 13 Biopesticides Registration Action Document



## DRAFT DOCUMENT R EQUIREMENT (G UIDELINE No ) MRID T OXICITY AND C LASSIFICATION a T OXICITY C ATEGORY Acute Pulmonary Toxicity/Pathogenicity (885.3150) 479150-05; 479150-09 ♂ and ♀ CD rats given a single intratracheal dose of P. macrostoma strain 94-44B spores (1.4 × 10 8 CFU per animal) ; viable test substance cleared from the organs. C ONCLUSION : the test material was not toxic, infective, nor pathogenic via the inhalation route. LD 50 (combined) >1.4 × 10 8 CFU per animal
C LASSIFICATION : Acceptable IV

Acute Injection ( c i.p.) Toxicity/ Pathogenicity (885.3200) 479150-05; 479150-10 ♂ and ♀ CD rats were given a single i.p. dose of P. macrostoma strain 94-44B spores (2.5 × 0 8 CFU per animal); viable test subs tance cleared from the organs. C ONCLUSION : the test material was not toxic, infective, nor pathogenic via the i.p. route. LD 50 (combined) >2.5 × 0 8 CFU per animal
C LASSIFICATION : Acceptable IV

Hypersensitivity Incidents (885.3400) 479150-05; 479150-11 Scotts submitted a statement summariz ing the number of persons who were potentially exposed to P. macrostoma during production. No incidents of hypersensitivity were reported among these indi viduals. Scotts stated that they will report all hypersensitivity incidents to the Agency if they occur.
C LASSIFICATION : Acceptable NA

Acute Oral Toxicity (870.1100) 479150-05; 479150-12 ♂ and ♀ Sprague-Dawley rats were gavaged with a single dose of ground-up P. macrostoma strain 94-44B in water (5,000 mg/kg bw); after 14 days of observation no treatment-related mortalities or clinical signs of toxicity were seen, and no gross findings were observed at necropsy. C ONCLUSION : The test material is not acutely toxic via the oral route. LD 50 (combined) >5,000 mg/kg bw
C LASSIFICATION : Acceptable IV

Acute Dermal Toxicity (870.1200) 479150-05; 479150-13 ♂ and ♀ New Zealand White rabbits were exposed via the dermal route to 4.5 × 10 4 CFU/g of ground-up P. macrostoma strain 94-44B. An aqueous paste of the test material was applied to an ~240 cm 2 area of exposed skin for 24 hours. After 14 days no treatment-related mortalities or clinical signs of toxicity were seen, and no gross findings were observed at necropsy. C ONCLUSION : The test material is not acutely toxic via the dermal route. LD 50 (combined)>5,000 mg/kg bw
C LASSIFICATION : Acceptable IV

Acute Inhalation Toxicity (870.1300) 479150-05; 479150-14 Scotts requested a waiver for this requirement because the acute pulmonary toxicity/pathogenicity study (MRID 479150-09) showed no signs of acute toxicity via the inhalation route. EPA accepts Sc otts rationale and has used the results of the acute pulmonary toxicity/pathogenicity study to assess the acute inhalation toxicity of P. macrostoma strain 94-44B. C ONCLUSION : P. macrostoma strain 94-44B is not acutely toxic via the inhalation route.
C LASSIFICATION : Acceptable IV

Acute Eye Irritation (870.2400) 479150-05; 479150-15 The eyes of ♀ New Zealand White rabbits were instilled with 0.1g (which contained 4.5 × 10 4 CFU/g) P. macrostoma strain 94-44B; it was left in place for 24 hours. Varying degrees of eye irritation was seen in all the animals; after three days all irritation resolved. C ONCLUSION : P. macrostoma strain 94-44B is moderately irritating to the rabbit eye.
C LASSIFICATION : Acceptable III

Primary Dermal Irritation (870.2500) 479150-05; 479150-16 ♀ New Zealand White rabbits were exposed via the dermal route to 4.5 × 10 4 CFU/g of P. macrostoma strain 94-44B. An aqueous paste of the test material was applied to an ~240 cm 2 area of exposed skin for four hours. After three days there were no treatment-related mortalities. Slight erythema was seen shortly after exposure; it resolved by 24 hours postapplication. C ONCLUSION : P. macrostoma strain 94-44B is not a skin irritant.
C LASSIFICATION : Acceptable IV

a Category I has the highest toxicity while Category IV has the lowest. For a description of the Toxicity Categories along with their limits, see 40 CFR 156.62.

b LD 50 =Median lethal dose , which is a statistically derived si ngle dose that can be expected to caus e death in 50% of the test animals when administered by the route indicated (ora l, dermal, inhalation). It is expressed as the amount of test substance per unit weight.

c i.p.=intraperitoneal.

2. Endocrine Effects . As required by the Administrator under the Federal Food, Drug, and Cosmetic Act (FFDCA) section 408(p), EPA has developed the Endocrine Disruptor Screening Program (EDSP) and has begun to implement the screeningP. macrostoma strain 94-44B page 14 Biopesticides Registration Action Document



## DRAFT DOCUMENT program that is to be used to test all pesticides 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.” FFDCA section 408(p)(4), authorizes the Administrator, by order, to exempt from the requirements of the Estrogenic Substances Screening Program a biologic substance or other substance if a determination is made that the substance is anticipated not to produce any effect in humans similar to an effect produced by a natura lly occurring estrogenic substance. Between October 2009 and February 2010, EPA issued test orders/data call-ins for the first group of 67 chemicals, which contain 58 pesticide active ingredients and nine inert ingredients. P. macrostoma is not among the group of 58 pesticide active ingredients on the initial list to be screened under the EDSP.
The Agency believes that P. macrostoma likely is a substance that would not produce any effect in humans similar to an effect produced by a naturally occurring estrogenic substance. As such, pursuant to section 408(p)(4), EPA will determine in the future whether it can exempt P. macrostoma from the requirements of EDSP section 408(p). In the event the Agency does determine to exempt this substance from the EDSP, an order will be issued. For further information on the status of the EDSP, the policies and procedures, the list of 67 chemicals, future lists, the test guidelines and the Tier 1 screening battery, please visit our website: www.epa.gov/endo/.

B. Exposure . Scotts intends to register two end-use products containing P. macrostoma strain 94-44B as the active ingredient. Phoma H is intended for homeowner-use and Phoma P is meant to be used by individuals working in co mmercial or agricultural settings. The primary difference between Phoma H and Phoma P, in term s of individual exposure, is that Phoma P is expected to be applied on a much larger scale than Phoma H. For example, the proposed label for Phoma H allows the product to be applied to flower beds by spot application. Phoma P can be applied to field-grown nursery flowers by broadcast application.

1. Occupational Exposure . Phoma P is a pesticide product intended for use by individuals who will use this product in a commercial or agricultural setting (e.g., lawn care, ornamental plant nursery) to control weeds in or around:

▪ Ornamental Plants (flowers and roses, ground covers, shrubs, and trees);

▪ Ornamental Grasses;

▪ Turfgrass (residential lawns, recreational areas, sod farms,

commercial areas, and golf courses)

▪ Seed-starting;

▪ Field-grown nursery and landscape plants; and

▪ Container uses.
Application to ornamental plants and grasses, and turfgrass will be by spot or broadcast application, using a spreader. Use of Phoma P in seed starting, field-grown nursery and landscape plant application, and cont ainer use will be via broadcast application (with a spreader). EPA expects that loaders and applicators will be exposed to Phoma P via the dermal and inhalation routes, and workers who reenter treated areas will be exposed by the dermal route.P. macrostoma strain 94-44B page 15 Biopesticides Registration Action Document



## DRAFT DOCUMENT 2

. Residential, School, and Day Care Exposure . Phoma H is a residential-use pesticide product proposed for use in controlling weeds in or around:



### ▪ Flowers and roses;



### ▪ Shrubs;



### ▪ Trees; 

### ▪ Ornamental Grasses;



### ▪ Lawns; and



### ▪ Seed starting.

Application to flowers and roses, shrubs, trees, and ornamental grasses will be by spot application only; application for lawns and seed-starting will be by spot and broadcast application (spreader). Phom a H is sold in packaging designed to minimize exposure during application (Messerschmidt 2011). For spot application, the product comes in a ready-to-use bottle where the user just needs to agitate the product (by turning the bottle) and remove the cap. For broadcast, Phoma H is placed in the spreader hopper; the user selects the correct application rate (which is listed on the product label) by adjusting a knob on the spreader.
Individuals who apply Phoma H are expected to be exposed via the dermal and possibly inhalation routes. After application, individuals in and around homes, schools, and other such settings may be exposed to Phoma P and/or Phoma H by touching plants that have been treated, or walking through or playing on treated turf.

C. Human Health Risk Characterization . Occupational exposure may occur through the dermal and inhalation routes. In acute toxicity testing, study investigators demonstrated that P. macrostoma 94-44B has low toxicity via these routes. The dermal LD 50 is >5,000 mg/kg bw and it is not a skin irritant. In acute pulmonary toxicity pathogenicity testing, instillation of 1.4 × 10 8 CFU per animal into the lungs did not cause adverse effects; based on these results, EPA expects that acute inhalation toxicity would also be low. P. macrostoma strain 94-44B was found to be slightly irritating to the eyes (Toxicity Category III); this concern can be mitigated with appropriate label language regarding eye safety.
Individuals who apply Phoma H in and around the home are expected to be exposed by the dermal and inhalation routes; however, such exposure is expected to be low. The packaging and labeling for Phoma H is designed to minimize exposure during application. An additional source of dermal exposure (to Phoma P and H) would be from touching plants that have been treated, or walking through or playing on treated turf. As discussed above, the dermal toxicity of P. macrostoma strain 94-44B is low, and, the environmental fate data show that P. macrostoma strain 94-44B is unlikely to persist at high levels for long periods of time.
Based on the available toxicity and exposur e information, EPA concludes that there is little risk to handlers, workers, bystanders, and others from the intended use of P. macrostoma strain 94-44B, as labeled.

V. ECOLOGICAL RISK ASSESSMENT AND ENDANGERED SPECIES ASSESSMENT A. Ecological Risk Assessment . Similar to human health risk assessment, in assessing the risk to nontarget 4 organisms, the Agency considers: the organisms likely to be exposed and their exposure level; the toxicity of the pesticide to the nontarget organisms; and whether the exposure will cause harmful effects. The effects can be direct (e.g., fish die from a pesticide entering waterways, birds do not reproduce normally after ingesting contaminated fish), or indirect (a hawk becomes sick from eating a mouse dying from pesticide poisoning). The

4 A nontarget organism is an organis m other than that wh ich the pesticide is intended to kill.P. macrostoma strain 94-44B page 16 Biopesticides Registration Action Document



## DRAFT DOCUMENT data requirements for nontarget toxicity and environmental fate of microbial pesticides can be found at 40 CFR 158.2150. Table 3, under section 1, below, lists the ecotoxicity data requirements and how they were met. Section 2 describes the environmental fate of P. macrostoma strain 94-44B when used as a pesticide product, and section 3 provides the environmental risk characterization.

1. Effects of Phoma macrostoma strain 94-44B to Nontarget Organisms (Ecotoxicity) (40 CFR 158.2150). In assessing the toxicity of a pesticide to the nontarget organisms, the Agency requires a number of Tier I ecotoxicity tests on nontarget terrestrial (e.g., birds, plants) and aquatic (e.g., fish) organisms; Tier I testing is considered to be the worst-case. Depending on the nature of the active ingredient, Tier II testing (environmental ex pression) may be automatically required; otherwise, it may be triggered by results seen in Tier I testing.
The scientific evidence from peer-reviewed literature and the results and information from studies conducted by the applicant are sufficient to satisfy all Tier I data requirements; Table 3 provides a summary of the submitted ecotoxicity data. With respect to Tier II requirements, the peer-reviewed literature (e.g., Bailey et al. 2010; Bailey et al. 2011a,b; and Zhou et al. 2004), which described the infection and colonization processes in plants and the environmental fate of P. macrostoma strain 94-44B, adequately satisfy Tier II testing, provided that certain risk mitigation measures are implemented. For deta ils on the submitted data, see EPA’s Environmental Risk Assessment (U.S. EPA 2011c).
The Agency also sought respective opinions from the U.S. Department of Agriculture’s (USDA) Animal Plant and Health Inspection Service (APHIS) Plant Protection and Quarantine (PPQ) program, and a plant pathologist at Cornell University concerning P. macrostoma as a plant pathogen and its ecological relevance as a plant pathogen, relative to other pathogenic species of Phoma

. Table 3 . Summary of Submitted Ecotoxicity Data for Phoma macrostoma strain 94-44B
R EQUIREMENT (G UIDELINE No ) MRID T OXICITY AND C LASSIFICATION

Avian oral toxicity (885.4050) 479150-18 30-day oral LD 50 : > 2.22 × 10 5 CFU/kg bw/day
C LASSIFICATION : Supplemental; adequate for EPA risk assessment a
Avian inhalation toxicity/pathogenicity (885.4100) study not required “Data required when the nature of the microbial pesticide and/or its toxins indicates potential pathogenicity to birds” (40 CFR 158.2150, testnote 3); P. macrostoma is not known or shown to be an avian pathogen.
Wild mammal toxicity/pathogenicity (885.4150) 479150-26 “Required on a case-by-case basis if results of tests required by §158.2140 are inadequate or inappropriate for assessment of hazards to wild mammals” (40 CFR 158.2150, testnote 4). Scotts submitted rationale regarding why this study is not needed. They argued that P. macrostoma is ubiquitous and P. macrostoma strain 94-44B has been shown to decline in population after application. The rat LD 50 rat for the submitted acute oral toxicity study (MRID 479150-12) is >5,000 mg/kg bw.
C LASSIFICATION : Acceptable rationale Freshwater fish toxicity/ pathogenicity (885.4200) 479150-19 32-day b LC 50 : >2.9 × 10 3 CFU/mL; no adverse effects were observed.
C LASSIFICATION : Acceptable
Freshwater invertebrate toxicity/pathogenicity (885.4240) 479150-20 21-day c EC 50 : > 3.78 × 10 2 CFU/mL

d NOAEC: 2.71 × 10 3 CFU/mL; based on growth and reproduction.
C LASSIFICATION : Acceptable
Estuarine/Marine fish testing (885.4280) studies not required “Required if the product is intended for direct applic ation into the estuarine or marine environment or expected to enter this environment in signi ficant concentrations bec ause of expected use or mobility pattern” (40 CFR 158.2150, testnote 6). Significant concentrations are not expected to reach marine/estuarine environments as a result of the proposed uses. Estuarine and marine invertebrate testing (885.4280)P. macrostoma strain 94-44B page 17 Biopesticides Registration Action Document



## DRAFT DOCUMENT R EQUIREMENT (G UIDELINE No ) MRID T OXICITY AND C LASSIFICATION

Nontarget plant testing (885.4300) 479150-21 Aquatic: ( Lemna gibba ) 7-day EC 50 =1.51 × 10 4 CFU/mL; NOAEC=4.4 × 10 3 CFU/mL C LASSIFICATION : Both studies are acceptable 483184-01 Terrestrial: A collection of studies showed that P. macrostoma strain 94-44B is toxic/pathogenic to several species of terrestrial broadleaf plants. Nontarget insect testing (885.4340) 479150-23 Green lacewing. 15-day LC 50 : >1 × 10 6 CFU/mL diet C LASSIFICATION : All studies are acceptable 479150-24 Lady bird beetle . 12-day dietary LC 50 : > 1 × 10 6 CFU/mL diet
479150-22 Parasitic hymenoptera . 16-day dietary LC 50 : > 1 × 10 6 CFU/mL Honey bee testing (885.4380) 479150-25 5-day LC 50 : >1 × 10 6 CFU/mL diet; the study was not long enough to assess pathogenicity.
C LASSIFICATION : Supplemental; adequate for EPA risk assessment

a Viability of the test substance was not confirmed, which is necessary for an ‘Acceptable’ rati ng from Health Canada’s PMRA; nonetheless, the study is acceptable for EPA risk assessment purposes.

b LC 50 =Median Lethal Concentration , which is a statistically deri ved concentration of a substance that can be expected to cause death in 50% of test animals. It is usually expressed as the wei ght of substance per weight or volume of water, air or feed (e .g., mg/L, mg/kg).

c EC 50 = Effective Concentration , which is the concentration of t he test substance at which the respiration rate is 50% of that shown by the control.

d NOAEC=no-observed-adverse-effect-concentration.

2. Environmental Fate . The environmental fate data show that P. macrostoma strain 94-44B is unlikely to persist at high levels for long periods of time or move great distances when applied to turf and ornamentals. Regarding its fate when used as a pesticide product, EPA concludes that:

▪ Macrocidins may be mobilized by runoff when soils are saturated; some

movement into adjacent areas could occur via this process 5 (Bailey et al. 2011b).

▪ Significant runoff is expected with applications to impervious surfaces.

▪ Persistence is expected within treated areas with repeated applications. Studies

show a declining trend after four months and survival of susceptible plants after one year has varied.

 In soil, P. macrostoma was observed to begin declining in viable numbers after two months and to below detection after one year, though in experiments where sunflower was sown a year after exposure some chlorosis but no decrease in emergence was seen when compared to controls (MRID 479150-01).

3. Environmental Risk Characterization

. In assessing the environmental risk that use of Phoma P and Phoma H may pose to the environment, the Agency considered the submitted data, environmental fate and exposure considerations from the proposed labels (e.g., apply product on a calm day), and information from the open literature. EPA concludes that:

▪ Exposure of nontarget organisms to P. macrostoma strain 94-44B and/or

macrocidins may occur in the terrestrial environment as a result of the proposed applications.

 For turf and ornamental applications, exposures are expected to be

limited to the treated site and immediately adjacent area. Long-term or frequent use in treated areas may lead to effects on susceptible rotational

5 Please Note: macrocidins taken up by roots produce chlorosis and disease in a dose-dependent manner regardless of viable P. macrostoma presence.P. macrostoma strain 94-44B page 18 Biopesticides Registration Action Document



## DRAFT DOCUMENT crop species. Significant offsite movement and nontarget exposures are expected with applications to impervious surfaces (e.g., patios, driveways, sidewalks). The proposed labels, however, do not include impervious surfaces as use sites.

▪ Significant exposures of nontarget organisms to P. macrostoma strain 94-44B

and/or macrocidins are not expected in aquatic environments.

▪ Adverse effects to birds, wild mammals, nontarget insects, honey bees,

freshwater fish and invertebrates, marine/estuarine fish and invertebrates, and aquatic plants are not expected.

▪ Offsite, some species of nontarget plants may be adversely affected where

significant exposure occurs.

▪ Nontarget plant effects may be significant for susceptible species in treated

areas, which may be a concern for susceptible rotational dicotyledonous plants.

▪ Effects to nontarget plants beyond the treated sites are expected to be limited

to immediately adjacent areas for applications to turf and ornamentals, and effects will be limited to more highly susceptible species.
Please note that the Agency may require additional testing if uses are expanded, if formulations change for the end-use products, or if incidents of adverse effects to nontarget organisms occur during commercial use of these products.

B. Threatened and Endangered Species Assessment

. Adverse effects to terrestrial vertebrates, nontarget insects, and freshwater and marine/estuarine animals and plants are not expected to occur due to exposure resulting from the proposed labeled applications of P. macrostoma strain 94-44B. Therefore, a no effect 6 determination is made for direct effects to federally listed threatened and endangered (listed) species within these taxa as a result of all proposed applications as labeled.

1. Direct Effects

. While the proposed applications are not expected to result in widespread losses of nonlisted, nontarget terrestrial plants, the potential for sublethal or lethal effects to individual listed terrestrial plants cannot be precluded. The potential occurrence of listed plants in treated areas may be unlikely, but it is unknown. Drift or runoff of the end-use product may deposit P. macrostoma strain 94-44B in areas containing listed plants. The proposed labels include use directions intended to limit drift. For example, the proposed Phoma P label states: “Apply only on a calm day when wind speed is less than 5 miles per hour.” Even though exposure may not result in mortality, it can cause sublethal necrosis and chlorosis that may contribute to reduced survival and reproduction of a listed plant. The proposed applications of P. macrostoma strain 94-44B, therefore, have the unlikely potential to directly affect individual listed terrestrial plants.

2. Indirect Effects and Effects to Critical Habitat. Effects to terrestrial vertebrates, nontarget insects, and freshwater and marine/estuarine animals and plants are not expected to occur as a result of proposed applications of P. macrostoma strain 94-44B. Therefore, indirect effects to listed species dependent on these taxa and related effects to their critical habitat 7 are not expected and a no effect determination

6 The U.S. Fish and Wildlife Service defines the term ‘no effect’ to mean that “its proposed action will not affect a listed spec ies or designated critical habitat” (www.fws.gov/endangered/esa-library/pdf/CH1-3.PDF).

7 The term ‘critical habitat’ means “areas that contain the physical or biological features that ar e essential to the conservatio n of the species that may need special management or protection” (www.fws.gov/endangered/).P. macrostoma strain 94-44B page 19 Biopesticides Registration Action Document



## DRAFT DOCUMENT is made for indirect and habitat effects to listed species dependent on these taxa for all proposed applications. The proposed applications of P. macrostoma strain 94-44B are not expected to result in widespread effects to nonlisted terrestrial plants, so indirect effects to listed generalist species 8 that are dependent on plants are not expected. EPA makes a no effect determination for indirect and habitat effects to all listed species that do not have an obligate relationship with any particular species of plant. Significant effects may occur in certain susceptible plant species, so applications of P. macrostoma strain 94-44B could affect a nonlisted (or listed) plant upon which a listed species depends exclusively for food or habitat. Therefore, applications of P. macrostoma strain 94-44B have the potential to cause indirect effects to listed species and also critical habitat for listed species with obligate relationships to susceptible plants; however, such a scenario has not been identified.

VI. RISK MANAGEMENT A. Risk Mitigation
1. General . The application methodology and equipment should be clarified on the label. And, specific use sites for turf (e.g., sod farms, golf courses) are not provided; they should be clarified on the label.

2. Environmental . To reduce exposure to terrestrial nontarget organisms, the following label language must be used: “Immediately water but do not saturate the soil.” Bailey et al. (2011b) show that macrocidins may be mobilized by runoff when soils are saturated. With such label language, runoff into adjacent areas as a result of applications to turf and ornamentals is expected to be minimized. Care should also be taken to not apply these products when soils are saturated (Bailey et al. 2010).

B. Future Changes to the Use Pattern . The Agency has the authority to require additional testing if uses are expanded, if formulations change for the end-use products, or if incidents of adverse effects occur during use of these products.

VII. REGISTRATION ELIGIBILITY DETERMINATION

A. Decision . The Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) section 3(c)(5) provides for the registration of new active ingredients if EPA determines that: (1) its composition is such as to warrant the proposed claims for it; (2) its labeling and other materials required to be submitted comply with the requirements of FIFRA; (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. The four eligibility criteria for registration of new active ingredients are satisfied for Phoma P and Phoma H. These products are not expected to cause unreasonable adverse effects to human health or the environment. Therefore, the new active ingredient P. macrostoma strain 94-44B is eligible for registration for the labeled uses. Please note, however, that certain terms of registration must be met.

8 In terms of ecology, a plant-eating ‘generalist’ (as opposed to a ‘s pecialist’) is a species that is able to eat a wide-variety of plants more or less equally (e.g., deer), whereas a specialist depends on a single or narrow range of plants (e.g., Koala bear).P. macrostoma strain 94-44B page 20 Biopesticides Registration Action Document



## DRAFT DOCUMENT B. Terms of the Registration . As terms of registration, EPA requires that the following 40 CFR 158.2120 data requirements under be completed. Most of these data are confirmatory; Scotts has informed the Agency that all the studies are underway.

P RODUCT C HEMISTRY AND C OMPOSITION

Manufacturing Process (Guideline No 885.1200) Once production of these new pesticide products is underway, a final manufacturing process needs to be submitted.

A NALYSIS AND C ERTIFIED L IMITS Five-Batch Analysis (Guideline No 885.1400) Required for Phoma TECH, Phoma H, and Phoma P.

P RODUCT C HEMISTRY AND C OMPOSITION

Stability to Normal and Elevated Temperatures, Metals and Metal Ions (Guideline No 830.6313) Required for the technical product.

Storage Stability (Guideline No 830.6317) Required for Phoma TECH, Phoma H, and Phoma P.

Corrosion Characteristics (Guideline No 830.6320) Required for Phoma TECH, Phoma H, and Phoma P.

VIII. 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 enf orcement of environmental laws, regulations, and policies. To help address potential environmental ju stice issues, the Agency 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 P. macrostoma strain 94-44B, compared to the general population.P. macrostoma strain 94-44B page 21 Biopesticides Registration Action Document



## DRAFT DOCUMENT BIBLIOGRAPHY
Studies, by MRID
479145-00 Scotts. 2009. Submission of Product Chemistry Data in Support of the Application for Registration of PHOMA P. The Scotts Company. Transmittal of 1 Study. November 16, 2009. 479145-01 Mendenhall, T. 2009. Bioherbicide End Product (EP): Physical and Chemical Characteristics: Color, Physical State, Odor, pH, Bulk Density. Corrosion, Storage Stability and Colony Forming Units, and Moisture Content. Project Number: SS/235. Unpublished study prepared by The Scotts Company, LLC. 15 p. November 16, 2009. 479146-00 Scotts. 2009. Submission of Product Chemistry Data in Support of the Application for Registration of PHOMA H. The Scotts Company. Transmittal of 1 Study. November 16, 2009. 479146-01 Mendenhall, T. 2009. Physical and Chemical Characteristics: Color, Physical State, Odor, pH, Bulk Density, Corrosion, Storage Stability and Colony Forming Units, and Moisture Content: S-13739: Bioherbicide End Product. Project Number: SS/235. Unpublished study prepared by The Scotts Company. 15 p. November 16, 2009. 479150-00 Scotts. 2009. Submission of Product Chemistry, Toxicity, and Fate Data in Support of the Application for Registration of Phoma Technical. The Scotts Company. Transmittal of 26 Studies. November 16, 2009. 479150-01 Falk, S.; Bailey, K.; Canale, A. 2009. Phoma Technical: Product Chemistry and Composition. Unpublished study prepared by The Scotts Company and Agriculture & Agri-Food Canada. 96 p. November 16, 2009. 479150-02 Falk, S.; Bailey, K.; Canale, A. 2009. Phoma Technical: Analysis and Certified Limits. Unpublished study prepared by The Scotts Company and Agricu lture & Agri-Food Canada. 26 p. November 16, 2009. 479150-03 Mendenhall, T. 2009. Bioherbicide TGAI: S-12642: Physical and Chemical Characteristics: Color, Physical State, Odor, pH, Bulk Density, Corrosion, Storage Stability and Colony Forming Units, and Moisture Content. Project Number: SS/236. Unpublished study prepared by The Scotts Company. 15 p. November 16, 2009. 479150-04 Messerschmidt, O.; Bailey, K. 2009. Phoma Technical: Physical and Chemical Characteristics: Storage Stability. Unpublished study prepared by OMC Ag Consulting and Agriculture & Agri-Food Canada. 11 p. November 16, 2009. 479150-05 Wilkinson, G.; Messerschmidt, O. 2009. Phoma Technical: Mammalian Toxicology Data Summary. Unpublished study prepared by OMC Ag Consulting and The Scotts Company. 10 p. November 16, 2009. 479150-06 Gingras, B. 2009. Batch Sample Viability of Two Microbial Pest Control Agent (MPCA) Preparations: Final Report. Project Number: 2199/SN1, 2199. Unpublished study prepared by IIT Research Institute. 25 p. November 16, 2009. 479150-07 Gingras, B. 2009. Sensitivity of Detection of Material B, the Spores of Phoma macrostoma , for Toxicity/Pathogenicity Testing in Rats: Final Report. Project Number: 2199/SN2, 2199. Unpublished study prepared by IIT Research Institute. 44 p. November 16, 2009. 479150-08 Lyang, N. 2009. Toxicity/Pathogenicity Testing of Phoma macrostoma , following Acute Oral Challenge in Rats: Final Report. Project Number: 2199/SN3, 2199. Unpublished study prepared by IIT Research Institute. 79 p. November 16, 2009. 479150-09 Lyang, N. 2009. Toxicity/Pathogenicity Testing of Material B, the Spores of Phoma macrostoma

, following Acute Intratracheal Challenge in Rats: Final Report. Project Number: 2199/SN4. Unpublished study prepared by IIT Research Institute. 73 p. November 16, 2009. 479150-10 Gingras, B. 2009. Toxicity/Pathogenicity Testing of Material B, the Spores of Phoma macrostoma

, following Acute Intraperitoneal Challenge in Rats: Final Report. Project Number: 2199/SN5. Unpublished study prepared by IIT Research Institute. 75 p. November 16, 2009. 479150-11 Wilkinson, G.; Messerschmidt, O. 2009. Tier 1 Studies: Reporting of Hypersensitivity Incidence (in Humans). Unpublished study prepared by The Scotts Company and OMC Ag Consulting. 4 p. November 16, 2009.P. macrostoma strain 94-44B page 22 Biopesticides Registration Action Document



## DRAFT DOCUMENT 479150-12 Johnson, W. 2009. Acute Oral Toxicity Study of Material C, the Ground End-Use Product (EP) of Phoma macrostoma , in Rats. Project Number: 2199/001, 2199/001/SN1. Unpublished study prepared by IIT Research Institute. 30 p. November 16, 2009. 479150-13 Johnson, W. 2009. Acute Dermal Toxicity Study of Material C, the Ground End-Use Product of Phoma macrostoma , in Rabbits. Project Number: 2199/001, 2199/001/SN4. Unpublished study prepared by IIT Research Institute. 32 p. November 16, 2009. 479150-14 Wilkinson, G.; Messerschmidt, O. 2009. Tier 1 Studies: Mammalian Toxicology Data Waiver Request: Acute Inhalation (in Rats). Unpublished study prepared by OMC Ag Consulting and The Scotts Company. 4 p. November 16, 2009. 479150-15 Johnson, W. 2009. Acute Eye Irritation Study of Material C, the Ground End-Use Product (EP) of Phoma macrostoma in Rabbits. Project Number: 2199/001, 2199/001/SN2. Unpublished study prepared by IIT Research Institute. 30 p. November 16, 2009. 479150-16 Johnson, W. 2009. Acute Dermal Irritation Study of Material C, the Ground End-Use Product (EP) of Phoma macrostoma , in Rabbits. Project Number: 2199/001, 2199/001/SN3. Unpublished study prepared by IIT Research Institute. 28 p. November 16, 2009. 479150-17 Wilkinson, G.; Messerschmidt, O. 2009. Nontarget Organisms and Environmental Fate Data Summary. Unpublished study prepared by The Scotts Company and OMC Ag Consulting. 10 p. November 16, 2009. 479150-18 Hubbard, P.; Beavers, J. 2008. Phoma macrostoma : An Avian Oral Pathogenicity and Toxicity Study in the Northern Bobwhite. Project Number: 560/104. Unpublished study prepared by Wildlife International Ltd. 51 p. November 16, 2009. 479150-19 Gallagher, S.; Krueger, H. 2009. Phoma macrostoma : A Five-Concentration Toxicity and Pathogenicity Test with the Rainbow Trout ( Oncorhynchus mykiss ): Final Report. Project Number: 560A/110. Unpublished study prepared by Wildlife International, Ltd. 66 p. November 16, 2009. 479150-20 Gallagher, S.; Krueger, H. 2009. Phoma macrostoma : A 21-Day Life-Cycle Toxicity and Pathogenicity Test with the Cladoceran Daphnia magna : Final Report. Project Number: 560A/109A, 560/010808/DAP/TP/SUB560. Unpublished study prepared by Wildlife International, Ltd. 74 p. November 16, 2009. 479150-21 Gallagher, S.; Krueger, H. 2009. Phoma macrostoma : A 7-Day Static-Renewal Toxicity Test with Duck Weed ( Lemna gibba G3): Final Report. Project Number: 560A/108. Unpublished study prepared by Wildlife International, Ltd. 53 p. November 16, 2009. 479150-22 Porch, J.; Krueger, H. 2009. Phoma macrostoma : A Dietary Pathogenicity and Toxicity Study with Parasitic Hymenoptera ( Pediobius foveolatus ): Final Report. Project Number: 560/107. Unpublished study prepared by Wildlife International, Ltd. 33 p. November 16, 2009. 479150-23 Porch, J.; Krueger, H. 2009. Phoma macrostoma : A Dietary Pathogenicity and Toxicity Study with Green Lacewing Larvae ( Chrysoperla rufilabris ): Final Report. Project Number: 560/106. Unpublished study prepared by Wildlife International Ltd. 33 p. November 16, 2009. 479150-24 Porch, J.; Krueger, H. 2009. Phoma macrostoma : A Dietary Pathogenicity and Toxicity Study with the Ladybird Beetle ( Hippodamia convergens ): Final Report. Project Number: 506/108. Unpublished study prepared by Wildlife International, Ltd. 32 p. November 16, 2009. 479150-25 Porch, J.; Sindermann, A.; Krueger, H. 2009. Phoma macrostoma : A Dietary Pathogenicity and Toxicity Study with the Honey Bee ( Apis mellifera ): Final Report. Project Number: 560/105. Unpublished study prepared by Wildlife International, Ltd. 31 p. November 16, 2009. 479150-26 Wilkinson, G.; Messerschmidt, O. 2009. Tier 1 Studies: Nontarget Organisms and Environmental Fate Data Waiver Request. Unpublished study prepared by The Scotts Company and OMC Ag Consulting. 10 p. November 16, 2009. 481451-00 Scotts. 2010. Submission of Product Chemistry Data in Support of the Applications for Registration of Phoma Tech, Phoma H and Phoma P. The Scotts Company. Transmittal of 3 Studies. July 8, 2010. 481451-01 Falk, S.; Canale, A. 2010. Product Chemistry and Composition: Phoma Technical. Unpublished study prepared by The Scotts Company. 17 p. July 8, 2010. 481451-02 Falk, S.; Canale, A. 2010. Product Chemistry and Composition: Phoma Technical. Unpublished study prepared by The Scotts Company. 5 p. July 8, 2010.P. macrostoma strain 94-44B page 23 Biopesticides Registration Action Document



## DRAFT DOCUMENT 481451-03 Wilkinson, G.; Messerschmidt, O. 2010. Nont arget Organisms and Environmental Expression Data Waiver Requests: Phoma Technical. Unpublished study prepared by The Scotts Company. 13 p. July 8, 2010. 482810-00 Scotts. 2010. Submission of Product Chemistry Data in Support of the Applications for Registration of Phoma Tech, Phoma H and Phoma P. The Scotts Company. Transmittal of 1 Study. November 1, 2010. 482810-01 Falk, S.; Bailey, K.; Canale, A. 2010. Product Chemistry and Composition (Response to Joint PMRA/EPA Review Letter of August 23, 2010): Phoma Technical. Unpublished study prepared by The Scotts Company. 27 p. November 1, 2010. 483184-00 Scotts. 2010. Submission of Efficacy Data in Support of the Applications for Registration of Phoma Tech, Phoma H and Phoma P. The Scotts Company. Transmittal of 1 Study. December 10, 2010. 483184-01 Bailey, K.; Falk, S.; Derby, J. 2010. Host Range Testing on Terrestrial Plants to Determine Pathogenicity to Phoma macrostoma 94-44B. Unpublished study prepared by Agriculture Canada and The Scotts Company. 19 p. December 10, 2010.

Reviews and other References

Aveskamp, M.M.; De Gruyter, J.; and Crous, P.W. 2008. Biology and recent developments in the systematic of Phoma, a complex genus of major quarantine significance. Fungal Diversity. 31:1-18. AAFC. 2009. AAFC Biopesticide: Phoma macrostoma . Government of Canada. Agriculture and Agri-Food Canada. 2009. AAFC No. 10777; Cat. No. A52-120/1-2009E-PDF; ISBN 978-1-100-10941-1 Bailey, K.L.; Pitt, W.M.; Derby, J.; Walter, S.; W. Taylor, W.; and Falk, S. 2010. Efficacy of Phoma macrostoma , a bioherbicide, for control of dandelion ( Taraxacum officinale ) following simulated rainfall conditions. Am. J. Plant Sci. Biotech., 4 (Special Issue 2):35-42. Bailey, K.L.; Pitt, W.M.; Leggett, F.; Sheedy, C.; and Derby, J. 2011a. The effects of Phoma macrostoma on nontarget plant and target weed species. Biol. Control, on-line publication available June 14, 2011. Bailey, K.L.; Pitt, W.M.; Leggett, F.; Sheedy, C.; and Derby, J. 2011b. Determining the infection process of Phoma macrostoma that leads to bioherbicidal activity on broadleaved weeds. Biol. Control, 2011, doi: 10.1016/j.biocontrol.2011.06.019. Boerema, G.H., and M.M.J. Dorenbosch. 1970. On Phoma macrostomum Mont., a ubiquitous species on woody plants. Persoonia, 6:49-58. Farr, D.F. and Rossman, A.Y. 2011. U.S. Department of Agriculture. Agriculture Research Service. Systematic Mycology and Microbiology Laboratory. Fungal Databases. Retrieved November 1, 2011, from /fungaldatabases/ Georgia. 2011. Widely Prevalent Fungi of the United States. University of Georgia, Center for Invasive Species and Ecosystem Health. Last web update: October 6, 2010. www.prevalentfungi.org/fungi.cfm. Messerschmidt. 2011. Email from Olav Messerschmidt, OM C Ag Consulting to Kathleen Martin, U.S. Environmental Protection Agency. November 14, 2011. U.S. EPA. 2011a. Memorandum from Joel Gagliardi to Kathleen Martin. Phoma macrostoma Montagne strain 94-44B: Human health risk assessment following joint EPA-PMRA review s. U.S. Environmental Protection Agency Office of Pesticide Programs. Biopesticides and Pollution Prevention Division. February 8, 2011. U.S. EPA. 2011b. Memorandum from Joel Gagliardi to Kathleen Martin. Phoma macrostoma Montagne strain 94-44B. U.S. Environmental Protection Agency. Biopesticides and Pollution Prevention Division. Microbial Pesticides Branch. September 15, 2011. U.S. EPA. 2011c. Memorandum from Shannon Borges to Kathleen Martin. Environmental risk assessment for the FIFRA Section 3 registration of Phoma macrostoma strain 94-44B (PC Code 080303; EPA Reg. Nos. 239-ETNE, 239- ETNG, 239-ENTU) for control of broadleaf weeds in turf and ornamentals. U.S. Environmental Protection Agency Office of Pesticide Programs. Biopesticides and Pollution Prevention Division. November 2, 2011. Zhou, L.; Bailey, K.L. ; and Derby J. 2004. Plant colonization and environmental fate of the biocontrol fungus Phoma macrostoma . Biological Control 30 (2004) 634–644. Zhou, L.; Bailey, K.L.; Chen, C.Y.; and Keri, M. 2005. Molecular and genetic analyses of geographic variation in isolates of Phoma macrostoma used for biological weed control. Mycologia, 97(3), 2005, pp. 612–620.