Document ID: EPA-HQ-OPP-2012-0128-0004
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2012-10-16T04:00Z

OFFICE OF CHEMICAL SAFETY
AND POLLUTION PREVENTION
                 UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
                            WASHINGTON, D.C.  20460

MEMORANDUM

DATE:		October 3, 2012

SUBJECT:	Science Review in Support of PCC 38-DD, Containing 100% Powdered Corn Cobs (37% Cellulose) As Its Active Ingredient.  

            Decision Number: 						447146
            DP Number: 							402045
            EPA File Symbol Number: 				84889-R
            Chemical Class: 							Biochemical
            PC Code: 								100154
            CAS Number:							9004-34-6 (cellulose)
            Active Ingredient Tolerance Exemptions: 		Nonfood-use
            MRID Numbers: 						48433401-48433405, 48433507-48433516, 48534101-48534110, 48924801*there is no DP Number for these MRIDs. 
                                                                  
FROM:		Angela L. Gonzales, Biologist	
            Biochemical Pesticides Branch
            Biopesticides & Pollution Prevention Division (7511P)

TO:			Leonard Cole, Senior Regulatory Specialist
            Biochemical Pesticides Branch
            Biopesticides & Pollution Prevention Division (7511P) 

ACTION REQUESTED

On behalf of Rode-Trol, LLC, E[x]ponent, Inc. requests registration of PCC 38-DD, a manufacturing-use product (MP) containing powdered corn cobs (37% cellulose). The chemical is a new biochemical active ingredient. The proposed MP is intended for use in the formulation of end-use products (EPs) that will be used as rodenticides in commercial and residential indoor settings. This product is related to the proposed end-use product, Rode-Trol (EPA File Symbol No.: 84889-E). In support of the proposed MP, the registrant submitted a proposed product label, Confidential Statement of Formulas (CSFs) dated 7/12/11, product chemistry data and information in MRIDs 48433401-48433402, 48534109, and 48924801 mammalian toxicology data and information in MRIDs 48433403, 48433405 and 48534101-48534108, and nontarget organism toxicology data and information in MRIDs 48433404 and 48534110. Companion animal/nontarget organism studies were 

provided in MRIDs 48433507-48433516. Additional information was submitted in cover letter and attachments dated 5/11/12. 

RECOMMENDATIONS AND CONCLUSIONS

1. The product chemistry submission is ACCEPTABLE pending resolution of the deficiencies discussed below.
	MRID 48433401-UPGRADEABLE					MRID 48433402-UPGRADEABLE
	MRID 48534109-UPGRADEABLE					MRID 48924801-ACCEPTABLE

a. Refer to the Confidential Appendix (CA) below.

b. The active ingredient statement must be revised on the label as follows:
		ACTIVE INGREDIENT:
		Powdered Corn Cobs*...............................100%
			*Contains 37% w/w Cellulose 

c. Refer to the CA below.

d. The applicant must rectify the discrepancy regarding the flash point data provided in MRID 48433402 and the data provided in box 9., "Flash Point/Flame Extension" on the CSF.

e. The rationale provided to satisfy the storage stability (OCSPP 830.6317) and corrosion characteristics (OCSPP 830.6320) is inadequate. Additional scientifically-sound rationale supported by references must be submitted or studies must be conducted. 

2. The mammalian toxicology submission is ACCEPTABLE.
	MRID 48433403-UNACCEPTABLE					MRID 48433405-SUPPLEMENTAL
	MRID 48433507-SUPPLEMENTAL					MRID 48433508-SUPPLEMENTAL
	MRID 48433509-SUPPLEMENTAL					MRID 48433510-SUPPLEMENTAL	
	MRID 48433511-SUPPLEMENTAL					MRID 48433512-SUPPLEMENTAL		
	MRID 48433513-SUPPLEMENTAL					MRID 48433514-SUPPLEMENTAL	
	MRID 48433515-SUPPLEMENTAL					MRID 48433516-SUPPLEMENTAL	
	MRID 48534101-ACCEPTABLE 					MRID 48534102-ACCEPTABLE
	MRID 48534103-ACCEPTABLE 					MRID 48534104-ACCEPTABLE
	MRID 48534105-ACCEPTABLE 					MRID 48534106-ACCEPTABLE
	MRID 48534107-ACCEPTABLE 					MRID 48534108-ACCEPTABLE

3. The nontarget organism toxicology submission is ACCEPTABLE.
	MRID 48433404-UNACCEPTABLE					MRID 48534110-SUPPLEMENTAL

NOTE TO RAL:

1. In the "Ingredients" row on the data matrix dated 7/12/11, the applicant listed the active ingredient as mono- and di- potassium salts of phosphorous acid, which must be revised.

2. Since the product may be applied in open trays, the applicant should include language on the label to preclude exposure to nontarget organisms/pets, such as cats and dogs. 

PRODUCT CHEMISTRY ASSESSMENT AND STUDY SUMMARIES 

I.	Active Ingredient Characterization  

Powdered corn cobs are shelled corn cobs that have been dried and ground. Cellulose, which is the actual pesticidal component in the cobs, comprises approximately 37% of the powdered corn cobs. The mode of action of cellulose as a rodenticide is posited to be interference with osmoregulation in the intestines of rats and mice which results in dehydration, malnutrition and consequently, death. A second theory regarding the mode of action of the active ingredient is that because cellulose is indigestible by non-ruminant mammals, consumption of excessive amounts of the material may result in intestinal dysfunction.  

Cellulose, a polysaccharide, is one of the most abundant organic compounds on Earth. It is the main constituent of plant cell walls and is also produced by some algae, fungi and bacteria. It is consumed in its natural state (as a component of plants) by humans and animals and is used in a variety of products, such as paper, textiles and building materials. (French, 2003) Various derivatives of cellulose, including powdered cellulose and microcrystalline cellulose are approved by the FDA for use in food and pharmaceutical products (21 CFR). Under the Federal Food, Drug and Cosmetic Act (FFDCA), EPA has exempted the compound from the requirement of a tolerance as a minimum risk active and/or inert ingredient in food-use pesticide products (40 CFR 180.950(e)). The Agency has also approved cellulose as a nonfood-use inert ingredient in pesticide products. In 2007, cellulose from powdered corn cobs was approved for use as a rodenticide in Canada by the Pest Management Regulatory Agency (PMRA).   

A.	Product Chemistry (MRIDs 48433401-48433402, 48534109 and 48924801)

All data requirements have been satisfied with the exception of storage stability and corrosion characteristics. Data submitted to support the product chemistry data requirements are summarized in Table 1 below.  Physical and chemical properties data are summarized in Table 2 below. Data Evaluation Records (DERs) were not created for MRIDs 48433401-48433402, 48534109 and 48924801. Refer to the CA below for more information.

TABLE 1. Product Chemistry Data Requirements for Powdered Corn Cobs (Cellulose) (40 CFR § 158.2030)
                             OSCPP Guideline No. 
                                     Study
                                   Results 
                                     MRID
                                   830.1550
                                      to
                                   830.1670
Product identity;
Manufacturing process;
Discussion of formation of unintentional ingredients
Submitted data satisfy the requirements for product identity, manufacturing process, and discussion of formation of impurities
48433401
48534109
                                   830.1700
Analysis of samples
Submitted data satisfy the requirements for analysis of samples. 
48924801
                                   830.1750
Certification of limits
Limits listed in the CSF are acceptable.
48433401
48534109
                                   830.1800
Analytical method
Acceptable.
48433401

                                       
TABLE 2. Physical and Chemical Properties of Powdered Corn Cobs (Cellulose) (40 CFR § 158.2030)
                               OCSPP Guideline 
                                   Property
                             Description of Result
                                   (PC 38-DD)
                                     MRID
830.6302
Color
Yellow-brown
                                   48433402
830.6303
Physical State
Solid
                                   48433402
830.6304
Odor
Faintly sweet
                                   48433402
830.6313
Stability to Normal and Elevated Temperatures, Metals and Metal Ions
Stable
                                   48433402
830.6315
Flammability
Flash point: 388ºF (open cup); 396 ºF (closed cup)
                                   48433402
830.6317
Storage Stability
Rationale is inadequate
                                   48433402
830.6319
Miscibility
N/A: product is not an emulsifiable liquid that will be diluted with petroleum solvents
                                   48433402
830.6320
Corrosion Characteristics
Rationale is inadequate
                                   48433402
830.7000
pH
N/A: TGAI/MP is not soluble or dispersible in water
                                   48433402
830.7050
UV/Visible Light
Absorption
Data are not necessary to inform the risk assessment
                                   48433402
830.7100
Viscosity
N/A: product is a solid
                                   48433402
830.7200
Melting Point/Range
Not expected to melt
                                   48433402
830.7220
Boiling Point/Range
N/A: TGAI is a solid
                                   48433402
830.7300
Bulk Density
 28.0 lb/ft[3]
                                   48433402
830.7520
Particle Size, Fiber Length and Diameter Distribution
Coarse dust index: 0.89
Coarse dust: 9.78 X 10[-5] %
Crude fiber: 36.9%
                                   48433402
830.7550
830.7560
830.7570
Partition Coefficient (n-
Octanol/Water)
Data are not necessary to inform the risk assessment
                                   48433402
830.7840
Water Solubility
6.3% in water
                                   48433402
830.7950
Vapor Pressure
N/A: TGAI/MP is a solid
                                   48433402

II.	Human Health Assessment

A.	Toxicology (MRIDs 48433403, 48433405, 48534101-48534108 and 48433507-48433516)
 
To satisfy the toxicology data requirements, data were provided from the open scientific literature. 
Reviews and analyses of these data by the World Health Organization (WHO) and PMRA were also submitted. For all data requirements (where applicable), adequate data on surrogate chemicals such as microcrystalline cellulose or refined-alpha cellulose were submitted. These chemicals are derivatives of cellulose. Instead of submitting data on the toxicity of powdered corn cobs, data were submitted on cellulose because the compound is considered to be the pesticidal component of the powdered corn cobs. The data submitted are acceptable to qualitatively assess the toxicity of the active ingredient. 

All toxicology data requirements have been satisfied per 40 CFR 158.2050.  The data presented in Table 3 below are a summary of the toxicity data for powdered corn cobs (cellulose).  DERs were not created for the submitted MRIDs; however, the relevant data and information from these MRIDs are summarized in Table 3 and in the subsequent sections.

Table 3. Mammalian Toxicology Data for Powdered Corn Cobs (Cellulose)  (40 CFR § 158.2050)
                           Study/OCSPP Guideline No.
                                    Results
                         Toxicity Category/Description
                                     MRID
Acute oral toxicity (rat)
(870.1100)
                      LD50 > 3160 mg/kg[1][,3] (males)
                LD50 > 5000 mg/kg[2][,3] (females and males)
                                      IV
                                   48433405
                                   48534101
Acute dermal toxicity (rat)	
(870.1200)
                LD50 > 2000 mg/kg[2][,3] (females and males)
                                      III
                                   48433405
                                   48534102
Acute inhalation toxicity	 (rat)
(870.1300)
                  LC50 > 5.35 mg/L2,3 (females and males)
                                      IV
                                   48433405
                                   48534103
Primary eye irritation (rabbit)	
(870.2400)
                            Minimally irritating[2]
                                      IV
                                   48433405
                                   48534104
Primary dermal irritation (rabbit)
(870.2500)
                               Nonirritating[2]
                                      IV
                                   48433405
                                       
Dermal sensitization (guinea pig)
(870.2600)
                              Not a sensitizer[2]
                                      N/A
                                   48433405
                                   48534105
90-Day oral toxicity 
(870.3100)
The proposed EP is nonfood-use. Uses are not anticipated to result in repeat oral exposure to humans.

Based on the review of available toxicity studies, the World Health Organization (WHO) has concluded that there is no evidence to indicate that consumption of microcrystalline cellulose in foods (when foods are produced according to good manufacturing processes) will result in toxic effects in humans. Humans are already naturally exposed to cellulose through consumption of plants and other foods.
                                       
                                       
                                       
                                       
                                       
                                       
                                   48433405
                                   48534106
                                       
                                       
90-Day dermal toxicity 
(870.3250)
Purposeful application and prolonged exposure to the human skin is not anticipated based on the use pattern (the proposed EP will be placed in bait stations or in trays and left alone to attract rodents). Additionally, humans are already exposed to cellulose and cellulose derivatives in paper products, textiles, pharmaceuticals, foods and plants.
                                       
                                       
90-Day inhalation toxicity
(870.3465)
Significant repeat inhalation exposure to the active ingredient as a gas, vapor or aerosol is unlikely based on the physical properties of the active ingredient. Powdered corn cobs (cellulose) are a solid material and the proposed EP is formulated as a pellet which is not inhalable. Although dust may be generated during the life-cycle of the product, significant exposure is not anticipated and the active ingredient is of low inhalation toxicity. The use pattern also precludes exposure (the proposed EP will be placed in bait stations or in trays and left alone to attract rodents). 
                                       
                                       
Mutagenicity-in vitro studies
(870.5100)
Significant human exposure is unlikely based on use pattern (the proposed EP will be placed in bait stations or in trays and left alone to attract rodents). The proposed EP is for nonfood-uses only. 

Various mutagenicity assays with microcrystalline cellulose in Salmonella typhimurium and Escherichia coli were reviewed by the WHO. All results were negative for genotoxicity.
                                       
                                       
                                       
                                       
                                       
                                       
                                   48433405
                                   48534108
                                       
Mutagenicity-in vivo micronucleus assay (870.5395)
Significant human exposure is unlikely based on use pattern (the proposed EP will be placed in bait stations or in trays and left alone to attract rodents). The proposed EP is for nonfood-uses only. 

In vivo mouse erythrocyte micronucleus mutagenicity assays using microcrystalline cellulose were reviewed by the WHO. All results were negative for genotoxicity.
                                       
                                       
                                       
                                       
                                       
                                       
                                   48433405
                                   48534108
                                       
Developmental toxicity
 (870.3700)
Significant female human exposure is unlikely based on use pattern (the proposed EP will be placed in bait stations or in trays and left alone to attract rodents). The proposed EP is for nonfood-uses only. 

No developmental toxicity effects were observed in studies with microcrystalline cellulose reviewed by the WHO. 
                                       
                                       
                                       
                                       
                                       
                                   48433405
                                   48534107
                                       
[1]Test substance was refined alpha-cellulose.
[2]Test substance was 85% microcrystalline cellulose.
[3]Highest dose tested.

1. Acute Toxicity

All data submitted to support the acute toxicology data requirements were submitted from the open scientific literature and were obtained from studies conducted on acceptable surrogate chemicals for cellulose, such as microcrystalline cellulose. Microcrystalline cellulose is purified, partially depolymerized cellulose (MRID 48433405, p. 95 of 110). Based on the available data and information, the Agency has classified cellulose as having low acute oral, acute dermal and acute inhalation toxicity.  It is minimally irritating to the eye, is not a dermal irritant and is not a dermal sensitizer.  

All of the acute toxicity data referenced above were also reviewed by the World Health Organization (WHO) and Canada's Pest Management Regulatory Agency (PMRA) and found to be acceptable.

2. Subchronic Toxicity

90-Day Oral

The 90-day oral data requirement is conditionally required for nonfood uses that are likely to result in repeat oral exposure to humans.  The proposed product is intended for use to formulate end-use products (EPs) which will be used as rodenticides in indoor settings. Repeat human oral exposure is not expected based on the proposed use pattern of the product containing the active ingredient. The proposed product containing the active ingredient is for nonfood-use and the product will be placed in bait stations and/or trays and left alone to attract rodents.  Label instructions will include precautionary statements to mitigate exposure to applicators and children. Any oral exposure is likely to be accidental; repeated oral exposure is not anticipated. In the case that accidental exposure should occur, hazard data indicate that ingestion of cellulose is not likely to result in toxic effects. Several subchronic and chronic oral toxicity studies were cited (actual studies were not provided) in MRID 48534106 for derivatives of cellulose. Most of the studies were conducted using microcrystalline cellulose. In their safety evaluation of microcrystalline cellulose, the WHO reviewed these studies and 

concluded that there is no evidence to indicate that consumption of microcrystalline cellulose in foods (when foods are produced according to good manufacturing processes) will result in toxic effects in humans (MRID 48433405, p. 25 of 100). Moreover, humans are already naturally exposed via the oral route to cellulose through consumption of plants and other foods.

90-Day Dermal

The 90-day dermal data requirement is conditionally required to support uses involving purposeful application to the human skin or uses that would result in prolonged dermal exposure and if data from a 90-day oral study are not required or the active ingredient is known or expected to be metabolized differently by the dermal route of exposure than by the oral route and the metabolite is of toxicological concern. Purposeful application and prolonged exposure to the human skin is not anticipated based on the use pattern of the proposed product (the product will be placed in bait stations and/or trays and left alone to attract rodents). Label instructions will include precautionary statements to mitigate exposure to children. Additionally, humans are already exposed via the dermal route to cellulose in paper products, textiles, foods and plants.

90-Day Inhalation

The 90-day inhalation data requirement is conditionally required if there is a likelihood of significant levels of repeated inhalation exposure to the pesticide as a gas, vapor or aerosol. For the proposed uses of powdered corn cobs (cellulose) as a pesticide, repeated inhalation exposure is unlikely based on the physical properties of the active ingredient, which is a solid. The proposed EP is formulated as a pellet which is not inhalable. Although dust may be generated from the product containing the active ingredient during shipping and/or handling, significant exposure is not anticipated and the active ingredient is of low inhalation toxicity.  The use pattern also precludes exposure (the proposed EP will be placed in bait stations or in trays and left alone to attract rodents).  

3. Developmental Toxicity 

Developmental toxicity data are conditionally required if significant exposure to female humans is expected from the proposed product's use under widespread and commonly recognized practice.  Significant exposure to females is unlikely based on the proposed use pattern of the product containing the active ingredient (the product will be placed in bait stations and/or trays and left alone to attract rodents). If used according to label instructions, significant oral, dermal and inhalation exposure to the  active ingredient is not anticipated. Moreover, no developmental toxicity effects were observed in studies with microcrystalline cellulose reviewed by the WHO (MRID 48433405, p. 21 of 110). 

4. Mutagenicity

Mutagenicity data are conditionally required to support nonfood uses if the use is likely to result in significant human exposure or if the active ingredient or its metabolites are structurally related to a known mutagen or belong to any chemical class of compounds containing a known mutagen.  Significant human exposure is unlikely based on the use pattern (the proposed EP will be placed in bait stations or in trays and left alone to attract rodents). Additionally, the proposed EP is for nonfood-uses only. Moreover, in studies reviewed by the WHO, microcrystalline cellulose was not mutagenic in various in vitro mutagenicity assays in Salmonella 

typhimurium and Escherichia coli and it was not mutagenic in in vivo mouse erythrocyte micronucleus mutagenicity assays. 

5. Companion Animal/Nontarget Animal Toxicity and Risk Characterization
In order to assess the potential for hazardous effects to various species, including pets, which may encounter the product containing the active ingredient during use, several non-guideline toxicity studies were conducted and submitted to the Agency (MRIDs 48433507-48433516). The species tested were: brushtail possum (Trichosurus vulpecula), rabbit (Oryctolagus cuniculus cuniculus), guinea pig (Cavia porcellus), cat (Felis catus), dog (Canis familiaris), ferret (Mustela furo), chicken (Gallus gallus), duck (Anas platyrhynchos) and goldfish (Carassius auratus). In each study, test species were deprived of their normal diet for 24 hours and then presented with the product containing the active ingredient and a half-ration of their normal food. The feeding schedule continued for up to 10 days. Animals were observed for daily consumption and changes in body weight and behavior. Animals that consumed at least 5g test substance/kg body weight were euthanized and examined for gross pathological effects. Possums, cats, chickens, dogs and ferrets typically refused the product after sampling small to moderate quantities. Guinea pigs, rabbits and male ducks consumed appreciable amounts of the product over the testing period. No changes in behavior were observed in any of these species during the test period. Gross pathology observations were normal for these species with the exception of observations of possible reduced urine production in possums, guinea pigs and rabbits and dry feces in some ducks. Goldfish mortality occurred between the first day and 19 days post-application (the product was applied to simulate an accidental spillage into a fish tank or pond). It was not determined if mortality occurred due to water contamination from the product or from consumption of the product. 
Based on the data provided, the product appears to be unpalatable to possums, cats, chickens, dogs and ferrets. Should accidental consumption occur, the available data indicate that accidental exposure should not result in toxic effects to these species. Although guinea pigs, rabbits and ducks may consume the product, the available data indicate that accidental exposure should not result in toxic effects. Accidental exposure to fish may result in mortality based on the data submitted; however, exposure is not expected based on the use pattern of the product. Risk to all of the above species is expected to be negligible based on minimal toxicity and lack of exposure if label instructions are followed.   

B.	Dose Response Assessment

No relevant toxicological endpoints were identified; therefore, a dose response assessment is not required.

C.	Drinking Water Exposure and Risk Characterization

Based on the proposed use pattern of powdered corn cobs (cellulose) as a rodenticide, pesticide residues in drinking water are not expected when products are used according to label instructions. Products containing the active ingredient will be used in indoor commercial and residential settings only; therefore, cellulose residues in drinking water are highly unlikely.   

D.	Occupational, Residential, School and Day Care Exposure and Risk Characterization
 
1.  Occupational Exposure and Risk Characterization

An occupational exposure assessment was not conducted for powdered corn cobs (cellulose). Based on the proposed use pattern and toxicity data available to the Agency, anticipated exposure is not likely to result in unreasonable risk to applicators/handlers. Any occupational exposure is likely to be via the dermal route and is expected to be brief in duration. Any inhalation exposure to dust generated during the life-cycle of the product is not expected to be significant and is also expected to be brief in duration. The active ingredient is of low dermal and inhalation toxicity. No relevant toxicological endpoints were identified and significant exposure in an occupational setting is not expected if label instructions are followed. Additionally, humans are already exposed to cellulose in the diet and through use of various products such as paper and textiles.  

2.  Residential, School and Day Care Exposure and Risk Characterization

A residential, school and day care exposure assessment was not conducted for powdered corn cobs (cellulose).  Based on the proposed use pattern and toxicity data available to the Agency, anticipated exposure is not likely to result in unreasonable risk to humans.  No relevant toxicological endpoints were identified and significant exposure is not expected if label instructions are followed. Any exposure in residential, school and/or day care settings is likely to be accidental and data available to the Agency indicate that the active ingredient is of low toxicity. Additionally, humans are already exposed to cellulose in the diet and through use of various products such as paper and textiles.   

E.	Risk Characterization

Risk to humans from pesticidal use of powdered corn cobs (cellulose) is expected to be negligible due to the low toxicity of the active ingredient and the anticipated lack of exposure based on the use pattern. The proposed product is not used in or on food, and is not directly applied to humans. Appropriate precautionary language requirements on end-use product labels will further mitigate exposure. 

The Agency has considered powdered corn cobs (cellulose) in light of the relevant safety factors in FIFRA.  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 from the use of this chemical when label instructions are followed.

III. Environmental Assessment

A.	Nontarget Organism Toxicology (MRIDs 48433404, 48433510-48433512 and 48534110)

All nontarget toxicology data requirements have been satisfied per 40 CFR 158.2060.  The information presented in Table 4 below is a summary of the nontarget toxicology data and information for powdered corn cobs (cellulose).  DERs were not created for the submitted MRIDs; however, data and information from these MRIDs are summarized in Table 4 and in the subsequent sections.   

TABLE 4.  Nontarget Organism Toxicity Requirements for Powdered Corn Cobs (Cellulose) (40 CFR § 158.2060)
                           Study/OCSPP Guideline No.
                                   /MRID No.
                                    Results
                         Toxicity Category/Description
                                     MRID
Avian acute oral toxicity
Colinus virginianus
(850.2100)

Waived. Avian exposure is not anticipated based on the indoor-use pattern.

Non-guideline toxicity studies were submitted where Mallard ducks and chickens were exposed to the proposed EP in the diet. Mallard ducks consumed the product over 3-10 days; there were no signs of toxicity and gross pathology was normal. The feces of some birds were dry and crumbly on day 6 (avian feces are normally wet). Chickens consumed low to moderate amounts of the product for about 2 days; thereafter, consumption was negligible. There were no signs of toxicity and gross pathology was normal. Feces were normal as well.   
                                       
                             Practically nontoxic
                                       
                                   48433511
                                   48433512
Avian dietary toxicity
Colinus virginianus and Anas platyrhynchos (850.2200)
Waived. Avian dietary exposure is not anticipated based on indoor-use pattern. 
                                      N/A
                                       
Aquatic invertebrate acute toxicity
(Daphnia magna)
(850.1010)

Waived. Aquatic invertebrate exposure is not anticipated based on indoor-use pattern. There is no direct application to aquatic sites and runoff is not expected based on use limitations to indoor settings.
                                      N/A
                                       
Freshwater fish LC50
(Oncorhynchus mykiss)
(850.1075)

Waived. Aquatic vertebrate exposure is not anticipated based on indoor-use pattern. There is no direct application to aquatic sites and runoff is not expected based on use limitations to indoor settings.

The proposed end-use product was highly toxic to goldfish based on a non-guideline toxicity study conducted where goldfish were exposed to the product in a simulation of accidental spillage into a fish tank or pond. It was not determined if toxicity was due to water contamination from the product or from consumption of the product. Although the product may be toxic to aquatic vertebrates, exposure to these organisms is highly unlikely if label instructions are followed.
                                      N/A
                                   48433510
Nontarget plant studies-seedling emergence
(850.4100)
Data are not required for indoor uses.  
                                      N/A
                                       
Nontarget plant studies-vegetative vigor 
(850.4150)
Data are not required for indoor uses.  
                                      N/A
                                       
Nontarget insect testing (Apis mellifera)
(880.4350)
Data are not required for indoor uses.  
                                      N/A
                                       

1.  Toxicity Summaries

Non-guideline toxicity studies were submitted for birds and non-rodent mammals (refer to the Companion Animal/Nontarget Animal Toxicity and Risk Characterization section above for a summary of submitted data). The indoor-use pattern precludes exposure for nontarget species. The proposed product containing the active ingredient will be placed in bait stations or bait trays indoors and left alone to attract rodents. Based on the submitted data and information, the active ingredient is not toxic to birds and mammals. The avian acute oral, avian dietary, aquatic vertebrate, aquatic invertebrate, nontarget plant and nontarget insect toxicity studies were waived due to the lack of anticipated exposure based on the indoor-only use pattern.   
   
B.	Environmental Fate and Groundwater Data

Environmental fate and groundwater data are not required at this time because the results of the nontarget organism toxicity assessment (Tier I data requirements) did not trigger these Tier II data requirements.  

C.	Ecological Exposure and Risk Characterization

A risk assessment was not conducted for nontarget organisms due to the unlikelihood of exposure based on the indoor-only use pattern of the active ingredient. Unreasonable effects to nontarget organisms are not anticipated when products are used according to label instructions.  

D.	Endangered Species Assessment

The Agency has not conducted a risk assessment that supports a complete endangered species determination.  The ecological risk assessment planned during registration review will allow the Agency to determine whether powdered corn cobs' (cellulose) use has "no effect" or "may effect" federally listed threatened or endangered species (listed species) or their designated critical habitats.  When an assessment concludes that a pesticide's use "may affect" a listed species or its designated critical habitat, the Agency will consult with the U.S. Fish and Wildlife Service and/or National Marine Fisheries Services (the Services) as appropriate.  

REFERENCES

French, A. D., Bertoniere, N. R., Brown, R. M., Chanzy, H., Gray, D., Hattori, K. and Glasser, W. 2003. 
	Cellulose. Kirk-Othmer Encyclopedia of Chemical Technology. Published Online: October 17, 2003