Document ID: EPA-HQ-OPP-2013-0361-0002
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2013-06-26T04:00Z

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

MEMORANDUM

DATE:		May 16, 2013

SUBJECT:	Environmental Protection Agency Assessment Memorandum for Meat Meal 
            
            Registration Review Case Number: 6041
            Chemical Class:	Biochemical
            PC Code: 100628
            CAS Number: 68131-12-4
            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 contain 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.  

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 chemistry 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
68131-12-4
Empirical Formula
N/A
Registration Review Case Number
6041

Product Chemistry Summary 
The Agency has conducted reviews 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.
Table 2. Biochemical Pesticides Product Chemistry Data Requirements for Meat Meal

                                 Guideline No.
                       Physical and Chemical Properties
                                   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 analysis
                                       A
CBI
                                       -
830.6302
Color
                                       A
Brownish
                                   43633301
830.6303
Physical state
                                       A
Solid
                                   43633301
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
Practically insoluble
                                   43633301
830.7950
Vapor pressure
                                      N/A
Waived
                                   43633301
   1. A=Acceptable. N/A=Not Applicable. N/D=Not Determined.

Human 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 adequately 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 will 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 directly 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 (NPIC) database, The Office of Pesticide Programs' Incident Data System (IDS) or The Environmental Incident Information System. No adverse effects to humans, domestic animals, or the environment were reported as a result of the use of meat meal as an animal repellent.   
 

Table 3. Human Health Values for Meat Meal (40 CFR § 158.2050)
		Data Requirement
LD50
Toxicity Category
MRIDs
Acute Oral Toxicity
OPPTS 870.1100
Data Gap
                                      N/D

43633305
Acute Dermal Toxicity
OPPTS 870.1200
Data Gap
                                      N/D

43633305
Acute 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
43633305

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 data 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" federally 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
                   Has Data Requirement 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
                                   43704003
      

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) Green 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. MRID # 43633304

Johansson, I. (1995) Hypersensitivity Incidents--Report: (Green Screen). Unpublished study prepared by 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-S: