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PC Code: 068403 EPA File Symbol No.: 5481
- LAI Ty pe of Review: Human Health Toxicity

OFFICE OF CHEMICAL SAFETY AND POLLUTION PREVENTION **UNITED ST AT**  **ES ENVIRONMENT AL**  **PROTECTION A GENCY** 

WA SHINGTON, D.C. 20460

**MEMORANDUM DATE:**  May

16, 201 3 **SUBJECT** : Environmental Protection Agency Assessment Memorandum for Meat Meal **Registration Review Case Number:** 60 41 **Chemical Class:** Biochemical **PC Code:** 100628 **CAS Number:** 68131
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- 4 **Type of Review:** Product Chemistry , Human Health and Ecological Reviews **FROM:** Leonard S. Cole, Jr. Senior Regulatory Specialist 05/16/13 Biochemical Pesticides Branch Biopesticides & Pollution Prevention Division (7511P) **TO :**  Linda A. Hollis, Chief

Biochemical Pesticides Branch Biopesticides & Pollution Prevention Division (7511P ) **ACTION REQUESTED** The following reviews c ontain the preliminary product chemistry assessment , human health assessment, and ecological toxicity for the biopesticide, Meat Meal in support of the development of the Registration Review Preliminary Work Plan.Meat Meal P C Code s : 100628

Ty pe of Review: Product Chemistry and Identity, Human Health and Ecological Toxicity Assessment (Registration Revie w)

2 **Introduction** The Agency has determined that all necessary product chemistry information is either available or has been waived for the pesticide active ingredient meat meal. The Agency has also determined to waive all of the human health data requirements based on submitted information, and the Agency has determined to waive all of the ecological data requirements based on submitted information. Meat meal is a sterilized, animal food by

- product produced from animal proteins at livestock rending plants. It is used as an animal food/feed supplement, an organic fertilizer and as an animal repellent. Meat meal is used as a powder which is sprinkled around the perimeter of the planted area and around the base of plants at a rate of one pound per 75

– 100 square feet. Meat meal is also used a as powder in bags and placed around the perimeter of ornamental and agricultural areas. Like the action of most animal repellents, meat meal is used to repel animals in an olfactory

manner. The first product containing this active ingredient was registered with the Agency in 1996 . Currently , there is one registered product containing meat meal which is an end

- use product (EP). Meat meal is intended to repel animals such as deer, rabbits, raccoons, and other wild

- life from damaging ornamental and agricultural crops. **PRODUCT CHEMISTRY AND PRODUCT IDENTITY** Concerning the product chemis try of meat meal , all biochemical pesticide data requirements for the active ingredient have been satisfied with data or have been waived and are summarized in Table 1
. **Table 1. Product Identity and Composition for meat meal Common Name**  Meat meal **Chemical Name, IUPAC** Meat meal **Molecular Weight** N/A **PC Code** 100628 **CAS Registry Number** 68131
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- 4 **Empirical Formula** N/A **Registration Review Case Number** 6041 **Product Chemistry Summary** The Agency

has conducted review s of the available product chemistry data and information for meat meal

. During the registration of the active ingredient, meat meal , the registrant submitted waiver rationales for some of the product chemistry and the physical and chemical characteristics. The rationales were accepted by the Agency

. These data are summarized in Table 2 , below.Meat Meal P C Code s : 100628

Ty pe of Review: Product Chemistry and Identity, Human Health and Ecological Toxicity Assessment (Registration Revie w)

3 **Table 2**  **. Biochemical Pesticides Product Chemistry Data Requirements for Meat Meal**  **Guideline No. Physical and Chemical** 

**Prope rties**  **Status 1**  **Value MRID**  **830.1100** Product Identity and Composition A Refer to Table 1.

- **830.1200** Description of starting

materials, production and formulation process A CBI
-
**830.1400** Discussion of formation

of impurities A CBI
- **830.1700** Preliminary anal ys is A CBI
- **830.6302** Color A Brownish 43633301 **830.6303** Physical state A Solid 4 3633301 **830.6304** Odor A Pungent 43633301 **830.6313** Stability to normal and elevated temperatures, metals and metal ions A Stable at room temperature; meat meal is not expected to be in contact with metals. 43633301

**830.7000** pH A 3.75 43633301 **830.7050** UV/Visible light

absorption N/A EPA has determined that these data are not required because they are not necessary to develop the risk assessment. 2 43633301

**830.7200** Melting point/melting

range A 500 0 F 43633301 **830.7220** Boiling point/boiling

range N/A Waived 43633301 **830.7300** Density A 1.5 lbs/gal 43633301 **830.7520** Particle size, fiber

length, and diameter distribution N/A Waived 43633301
**830.7550 830.7560**  **830.7570** Partition coefficient (n

Octanol/Water) N/A Waived 43633301
**830.7840** Water solubility A Practicall y 43633301Meat Meal P C Code s : 100628

Ty pe of Review: Product Chemistry and Identity, Human Health and Ecological Toxicity Assessment (Registration Revie w)

4 insoluble **830.7950** Vapor pressure N/A Waived 43633301 1. A=Acceptable. N/A=Not Applicable. N/D=Not Determined. **H uman Health**  EPA’s preliminary review of the available human health data/information on record show that the acute oral toxicity, acute dermal toxicity, acute inhalation toxicity, primary eye irritation, primary dermal irritation and dermal sensitization data requirements have not been adequatel y addressed. Data gaps have been identified for meat meal (indicated with a “Data Gap” designation in Table 3) based on the inadequacy of the data/information submitted. EPA will make the determination as to whether additional data/information wil l be required in the final work plan. Table 3 reflects biochemical data requirements and either anticipated data needs or the fulfillment of the human health data requirements for meat meal (U. S. EPA, 2013). **Tolerances** No tolerance or exemptions are associated with the use of this biochemical pesticide because it is not applied directl y to vegetation and therefore, all uses are non food uses. **Incidents** During the timeframe from December 1, 1996 to May 15, 2013 , there were no incidents reported from the use of meat meal to The National Pesticides Information Center (NPI C) database , The Office of Pesticide Programs' Incident Data System (IDS) or The Environmental In cident Information System
. No adverse effects to human s , domestic animal s , or the environment were reported as a result of the use of meat meal as an animal repellent

.Meat Meal P C Code s : 100628

Ty pe of Review: Product Chemistry and Identity, Human Health and Ecological Toxicity Assessment (Registration Revie w)

5 **Table 3**  **. Human Health Values for**  **Meat Meal (40 CFR § 158.2050)** 

**Ecological Toxicity and Endangered Species** EPA’s preliminary

review of the available ecological toxicity data/information on record shows that the ecological toxicity data requirements have not been adequately addressed. The EPA considers the inadequacy of the data/information on record to be a dat a gap for the listed studies. Data gaps have been identified for these data requirements (indicated with the Data Gap designation in Table 4) based on the inadequacy of the data/information submitted.
**F. Endangered Species**  The EPA has not prepared a risk assessment that supports a complete endangered species determination for meat meal. During Registration Review, the EPA plans on conducting an ecological risk assessment to determine whether use of meat meal will have “no effect” or “may affect” feder ally

listed threatened or endangered species (listed species) and/or their designated critical habitat. When an assessment concludes that a pesticide’s use “may affect” a listed species and/or its designated critical habitat, the EPA will consult with the U.S. Fish and Wildlife Service and/or National Marine Fisheries Service (the Services), as appropriate

.

**Data Requirement**  **LD50 Toxicity Category**  **MRIDs** Ac ute Oral Toxicity OPPTS 870.1100 Data Gap N/D 43633305 Ac ute Dermal Toxicity OPPTS 870.1200 Data Gap N/D 43633305 Ac ute Inhalation Toxicity OPPTS 870.1300 Data Gap N/D 43633305 Primary Eye Irritation OPPTS 870.2400 Data Gap N/D 43633305 Primary Dermal Irritation OPPTS 870.2500 Data Gap N/D 43633305 Dermal Sensitization OPPTS 870.2600 Data Gap N/D 43633305 Genotoxicity 870.5100 Waiver N/A 43633305 90
- day Oral Toxicity 870.3100 Waiver N/A 43633305 Developmental Toxicity 870.3700 Waiver N/A 43633305 Immunotoxicity 870.3550 Waiver N/A 43633305Meat Meal P C Code s : 100628

Ty pe of Review: Product Chemistry and Identity, Human Health and Ecological Toxicity Assessment (Registration Revie w)

6 Lakeshore Enterprises (1995) Submission of Product Chemistry Data in Support of Application for Registration of and Exemption from Tolerance for Green Screen Powder and Green Screen Bags. MRID # 436333300 Butts, E. (1995) Green Screen Powder and Green Screen Bags

-- Product Identity and Disclosure of Ingredients. Unpublished study prepared by

E. R. Butts International, Inc. MRID # 43633301 Butts, E. (1995) Green Screen Powder and Green Screen Bags

-- Description of Beginning Materials and Manufacturing Process. Unpublished study prepared by

E. R. Butts International. MRID # 43633302 Butts, E. (1995) Gr een Screen Powder and Green Screen Bags

-- Discussion of the Formation of Impurities. Unpublished study prepared by

E. R. Butts International. MRID # 43633303 Butts, E. (1995) Green Screen Powder and Green Screen Bags

-- Preliminary Analysis and Certification of Ingredient Limits. Unpublished study prepared by

E. R. Butts International. **Data Requirement Has Data Requirem**  **ent Been Addressed? How?**  **MRID No.** Avian Acute Oral Toxicity OPPTS 850.2100 Data Gap 43704003 Avian Dietary Toxicity OPPTS 850.2200 Data Gap 43704003
Fish acute toxicity, freshwater OPPTS 850.1075 Data Gap 43704003 Aquatic invertebrate acute toxicity,

freshwater OPPTS 850.1010 Data Gap 43704003 Terrestrial Plant Toxicity, Seedling

emergence OPPTS 850.4100 Data Gap 43704003 Terrestrial Plant Toxicity, Vegetative

vigor OPPTS 850.4150 Data Gap 43704003 Nontarget Insect Testing OPPTS 850.4350 Data Gap 43704003Meat Meal P C Code s : 100628

Ty pe of Review: Product Chemistry and Identity, Human Health and Ecological Toxicity Assessment (Registration Revie w)

7 MRID # 43633304 Johansson, I . (1995) Hy

persensitivity

Incidents

-- Report: (Green Screen). Unpublished study prepared b y Lakeshore Enterprises. MRID # 43633305
cc: L.S. Cole, Jr., M.S., to L . Hollis, Chief BPPD , BPPD Science Review File , IHAD/ARS L. S. Cole, Jr., M.S., FT, PY
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