Powdered Corn Cobs (Cellulose) DP Number: 402045 PC Code: 100154 EPA File Symbol No. : 84889
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OFFICE OF CHEMICAL SAFETY AND POLLUTION PREVENTION **UNITED ST AT**  **ES ENVIRONMENT AL**  **PROTECTION A GENCY** 

WA SHINGTON, D.C. 20460

**MEMORANDUM DATE:**  October 3 , 2012 **SUBJECT** : Science Review in Suppo rt 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:** B iochemical **PC Code:** 100154 **CAS Number:** 9004
- 34
- 6 ( cellulose) **Active Ingredient Tolerance Exe**  **mptions:** 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 & Poll ution Prevention Division (7511P ) **TO :**  Leonard Cole , Senior Regulatory Specialist Biochemical Pesticides Branch Biopesticides & Poll ution Prevention Division (7511P ) **ACTION REQUESTED** On behalf of Rode
- Trol, LLC , E xponent , 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 w ill be used as rodenticide s in commercial and residential indoor settings. This product is related to the proposed end
- use product, Rode
- Trol (EPA File Sy mbol No.: 84889
- E)
. In support of the proposed MP, the registrant submitted a proposed product label, Confidential Statement of Formula s (CSF s) 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 werePowdered Corn Cobs (Cellulose) DP Number: 402045 PC Code: 100154 EPA File Symbol No. : 84889
- R Ty pe of Review: Product Chemistry , Toxicology, Nontargets 2 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**  **4843340 1**  **- UPGRADEABLE**  **MRID 48 433402**  **- 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 4843340 3**  **- UNACCEPTABLE**  **MRID 48 433405**  **- 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 48 534101**  **- 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 4843340**  **4 -**  **UN ACCEPTABLE**  **MRID 48 534110**  **- SUPPLEMENTAL**  NOTE TO RAL: 1. Inthe “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 tray s, 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**Powdered Corn Cobs (Cellulose) DP Number: 402045 PC Code: 100154 EPA File Symbol No.: 84889
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**I. Active Ingredient Characteri**  **zation** 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 deh ydration, malnutrition and consequently, death. A second theory regarding the mode of action of the active ingredient is that because c ellulose is indigesti ble by non - ruminant mammals, consumption of excessive amounts of the material may result in intestinal dy sfunction. Cellulose, a poly sacchari de, is one of the most abundant organic compounds on Earth. It is the main constituent of plant cell wa lls and is also produced by some algae, fungi and bacteria. Itis consumed in its natural state (as a component of plants) by humans and animals and is used in a variet y of products, such as paper, textiles and building materials. ( French, 2003) Various de rivatives of cellulose, including powdered cellulose and microcry stalline cellulose are approved b y 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 ing redient in pesticide products. In 2007, c ellulose 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 r equirements 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. Phy sical and chemical properties data are summarized in Table 2 below. Data Evaluati on 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. 48433401Powdered Corn Cobs (Cellulose) DP Number: 402045 PC Code: 100154 EPA File Symbol No.: 84889
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**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 Phy sical State Solid 48433402 830.6304 Odor Faintly sweet 48433402 830.6313 Stability to Normal and E levated

Tem peratures, Metals and Metal I ons 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 w ater 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 analy ses of these data by the World Hea lth 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 cellulo se. Instead of submitting data on the t oxicity of powdered corn cobs, data were submitted on cellulose because the compound is considered to be the pesticidal comp onent of the powdered corn cobs. The data submitted are acceptable to qualitatively

assess th e 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.Powdered Corn Cobs (Cellulose) DP Number: 402045 PC Code: 100154 EPA File Symbol No.: 84889
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**Table 3 . Mam**  **malian 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) LD 50 > 3160 mg/kg 1 ,3 (m ales) LD 50 > 5000 mg/kg 2 ,3 (females and males) IV 48433405 48534101 Acute dermal toxicity (rat) (870.1200) LD 50 > 2 000 mg/kg 2 ,3 (females and males) III 48433405 4853410 2 Acute inhalation toxicity (rat) (870.1300) LC 50 > 5.35 mg/L 2,3 (females and males) IV 48433405 4853410 3 Primary eye irritation (rabbit) (870.2400) Minimally irritating 2 I V 48433405 4853410 4 Primary dermal irritation (rabbit) (870.2500) Nonirritating 2 IV 48433405 Dermal sensitization (guinea pig) (870.2600) Not a sensitizer2 N/A 48433405 4853410 5

90
- Day oral toxicity (870.3100) The p roposed EP is nonfood
- use. Uses are not anticipated to result in repeat oral exposure to humans. Based on the re view 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 thr ough consumption of plants and other foods. 48433405 4853410 6

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)
. Add itionally, 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 i s 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 4853410 8Powdered Corn Cobs (Cellulose) DP Number: 402045 PC Code: 100154 EPA File Symbol No.: 84889
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**Table 3 . Mam**  **malian Toxicology Data for Powdered Corn Cobs (Cellulose)**  **(40 CFR § 158.2050) Study/OCSPP Guideline**  **No. Results**  **Toxicity Category/Description**  **MRID**
Mutagenicity
- in viv o 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. I n vivo mouse erythrocyte micronucleus mutagenicity assays using microcrystalline cellulose were reviewed by the WHO . All results were negative for genotoxicity. 48433405 4853410 8

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 cel lulose r eviewed by the WHO
. 48433405 4853410 7
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 microcry stalline cellulose. Microcry st alline cellulose is purified, partiall y depoly merized 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 min imally 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 b y 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 likel y to result in repeat oral exposure to humans. The p roposed 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 ingred ient is for nonfood
- use and the product will be placed in bait stations and/or tray s and left alone to attract rodents
. Label instructions will include precautionary statements to mitigate exposure to applicators and children. An y 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 s ubchronic and chronic or al toxicity studie s were cited (actual studies were not provided) in MRID 48534106 for derivatives of cellulose. Most of the studies were conducted using microcry stalline cellu lose
. In their safet y evaluation of microcry stalline cellulose, the WHO reviewed these studies andPowdered Corn Cobs (Cellulose) DP Number: 402045 PC Code: 100154 EPA File Symbol No.: 84889
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concluded that there is no evidence to indicate that consumption of microcry stalline 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 naturall y 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 b y the dermal route of exposure than b y the oral route and the metabolite is of toxicolog ical concern. P urposeful 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 tray s 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 Inh alation 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 . F or the proposed uses of powdered corn cobs (cellulose) as a pesticide, repeated inhalation exposure is unli kely based on the phy sical 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 tray s and left alone to attract rodents). **3. Developmental Toxicity** Developmental toxicity

data are conditionally

required if significant exposure to femal e 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 plac ed in bait stations and/or tray s and left alone to attract rodents)
. If used according to label instructions, significant oral, dermal and inhalation exposure to the active ingr edient is not anticipated. Moreover, n o developmental toxicity effects were ob served in studies with microcry stalline 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 an y chemical class of compounds containing a known mutagen. Significant human exposure is unlikely based on the use pattern (the proposed EP will be placed i n bait stations or in tray s and left alone to attract rodents). Additionally , the proposed EP is for nonfood
- uses onl y. Moreover, in studies reviewed by the WHO, microcry stalline cellulose was not mutagenic in v arious in vitro mutagenicit y assa ys in SalmonellaPowdered Corn Cobs (Cellulose) DP Number: 402045 PC Code: 100154 EPA File Symbol No.: 84889
- R Ty pe of Review: Product Chemistry, Toxico logy, Nontargets 8
typhimurium and Escherichia coli and it was not mutagenic in in vivo mouse ery throcy te micronucleus mutagenicity

assay s. **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 ). Ineach 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 day s. 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 t ypicall y refused the pro duct 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 possum s, guinea pigs and rabbits and dry feces in some ducks. Goldfish mortality occurred between the first day and 19 day s post - applicati on (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 a ppears 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 i n 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 propos ed use pattern of powdered corn cobs (cellulose) as a rodenticide , pesticide residues in drinking water are not expected when products are used ac cording 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 highl y unlikely
.Powdered Corn Cobs (Cellulose) DP Number: 402045 PC Code: 100154 EPA File Symbol No.: 84889
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**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 ris k to applicators/handlers
. An y occupational exposure is likely to be via the dermal r oute and is expected to be brief in durati on. An y 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. T he active ingredient is of low dermal and inhalation toxicity
. No relevant toxicological end points were identified and significant exposure in an occupational setting is not expected if label instructions are followed
. Add itionally , 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 ris k to humans. No relevant toxicological endpoints were identified and significant exposure is not expected if label instruction s 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
. Addi tionally , humans are already exposed to cellulose in the di et 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 anti cipated lack of exp osure 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 requireme nts on end
- use product labels will further mitigate expos ure . The Agen cy has considered powdered corn cobs (cellulose) in light of the relevant safet y 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, wi ll result from the use of this chemical when label instructions are followed. **III. Environmental Assessment A.**  **Nontarget Organism Toxicology ( MRID**  **s 48433404**  **, 48433510 -**  **48433512 and 48534110**  **)** All nontarget toxicology

data requirements have b een satisfied per 40 CFR 158.206 0
. 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 summ arized in Table 4 and in the subsequent sections
. **TABLE 4. Nontarget Organism Toxicity Requirements for Powdered Corn Cobs (Cellulose)**  **(40 CFR § 158.2060)**Powdered Corn Cobs (Cellulose) DP Number: 402045 PC Code: 100154 EPA File Symbol No.: 84889
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**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 ab out 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 invert ebrate 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 LC 50 ( 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 h ighly toxic to goldfish b ased 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, e xposure to these organisms is highly unlikely if

label instructions are followed. N/A 48433510

Nontarget plant studies
- seedling em ergence (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/APowdered Corn Cobs (Cellulose) DP Number: 402045 PC Code: 100154 EPA File Symbol No.: 84889
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**1. Toxicity Summaries** Non
- guideline t oxicity

studies were submitted for birds and non - rodent m ammals (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 speci es. The proposed product containing the active ingredient will be place d 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 avi an 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
- onl y 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 p roducts 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