# SOUTHERN 

# GARDENS

ACTION: Information and Data Submitted in Accordance with FIFRA Section 5 FEE CATEGORY: 

### 8771, 10 month review time

. REGISTRATION FEE: 

### $31,907.50 total (includes approved Small Business Waiver of 

### 75% of total PRIA fee) E-mail Contact: forsterconsults@gmail.com
Via Courier October 28, 2015 U.S. Environmental Protection Agency Document Processing Desk (BPPD) Office of Pesticide Programs Document Processing Room S-4900 1 Potomac Yard 2777 S. Crystal Drive Arlington , VA 22202 RE: Information Submitted in Accordance with FIFRA Section 5 and 40 CFR 

### 172: Application for Experimental Use Permit and Associated Temporary Tolerance for Genetically Engineered Citrus tristeza virus expressing spinach defensin proteins 2, 7 and/or 8 derived from spinach (spinacia o/eracea L.) 

### (GE CTV-SoD). Southern Gardens Citrus Nursery, LLC Company Number: 

### 88232
. To Whom it May Concern: Southern Gardens Citrus Nursery, LLC, (Southern Gardens) is submitting an application under the provisions of FIFRA Section 5 FIFRA for genetically engineered Citrus tristeza virus expressing spinach defensin proteins 2 , 7 and 8 derived from sp i nach (spinacia o/eracea L.) (GE CTV-SoD)

. GE CTV-SoD is introduced into citrus trees or seedlings via grafti ng i n order to protect, or assist trees in recovery, from citrus greening disease, or Huanglongbing. This application also contains a petition to exempt genetically engineered Citrus trist eza virus expressing spinach defensin proteins 2, 7 and 8, from the requirement for a temporary tolerance under FFDCA Section 408(a). This application includes a transmittal document and three (3) copies of administrative mate rials and data reports in support of the above-referenced registration actions

.



## Southern Gardens Citrus - Orange juice is 

# our businessrM 1 820 CR 833 C lewiston , Florida 33440 Te lepho ne: (863) 983
-3030 Fax: (863) 902
-4 1 23

### This EUP will allow Southern Gardens to conduct larger field studies and collect data necessa r y to support an application for a FIFRA Section 3 registration for GE CTV-SoD constructs. Information and data submitted in support of this Experimental Use Permit and Petition for an Exemption from the Requirement of a Temporary Tolerance provide rationale and background information indicating no adverse effects are anticipated. Information presented herewith indicate that GE CTV expressing spinach defensin proteins pose virtually no risk to human , domestic animals or wildlife health. In addition, data and rationale presented here indicate that GE CTV
- SoD pose no risk to non-target organisms , including pollinators

. Please call me at 302-383
-3313, or contact me via e-mail at forsterconsults @gm ai l.com if you have any questions regarding this appl ication

. Sincerely,

# t)~**r;~**

Vickie Forster Authorized Representative for South e rn Gardens Citrus Nursery, LLC
cc: Dr

. Kenneth Haymes, Regulatory Action Leader- BPPD (H-7511 P)



## South e rn Ga rde ns Citru s- Ora nge juice is 

# our bu sin essTM 1 820 C R 833 C lewiston , Flo rid a 33440 Te lep hon e: (863 ) 983
-3030 Fax: (863) 902
-41 23

### DATA TRANSMITTAL DOCUMENT
Southern Gardens Citrus Nursery, LLC Attention : Vickie Forster Authorized Agent for Southern Gardens Citrus Nursery, LLC Forster 

### & Associates Consulting, LLC P.O

. Box 4097 Greenville, DE 19807 Regulatory Action in Support of Which this Package is Submitted: Information Submitted in Accordance with FIFRA Section 5 and 40CFR172:
Product Name : EPA Registration No.: Transmittal Date: Volumes Submitted: Genetically Engineered Citrus tristeza virus 

### Expressing Spinach Defensin Proteins (GE CTV-SoD) 88232-EUP-2 October 28, 2015

Volume No. Document Guideline Title No. No. SGC N/A Administrative Materials: 1 88232-EUP-2 Application for Pesticide Registration, Admin EPA Form 8570-17 Confidential Statements of Formula, EPA Form 8570-4 Certification with Respect to Citation of Data, EPA Form 8570-34 Data Matrix forGE CTV-SoD, EPA Form 8570-35 Product Labeling forGE CTV-SoD and six (6) Constructs included in this EUP Application FIFRA Section 5 (EUP) Application: Sections A-G Petition for The Exemption from a Requirement of a Tolerance on a TimeLimited Basis (40 CFR 174.et seq.) Notice of Filing for Tolerance Exemption of GE CTV-SoD Small Business PRIA Waiver Approval (July 27, 2015) Payment Receipt of PRIA Fee Category 8771 MRIDVolume No. Document No. Guideline No. Title MRID 2 SGC-039 885.1100; " Product Characterization of Genetically 885.1200; Engineered Citrus tri steza virus Expressing 885

. 1300; Spinach Defensin Proteins 2, 7 and 8 (GE CTV885

. 1400 SoD)", SGC-039. Author: M. lrey 3 SGC-043 885

.3050 "Genetically Engineered Citrus tristeza virus Expressing Spinach Defensin Proteins 2, 7 and 8 (GE CTV-SoD): Rationale for Not Conducting a Guideline Study
- Acute Oral Toxicity/Pathogenicity", SGC-043

. Author: V

. Forster 4 SGC-044 885

.3100 " Genetically Engineered Citrus tri steza virus Expressing Spinach Defensin Proteins 2, 7 and 8 (GE CTV-SoD): Rationale for Not Conducting a Guideline Study
- Acute Dermal Toxicity/Pathology", SGC-044

. Author: V. Forster 5 SGC-045 885.3150 "Genetically Engineered Citrus tristeza virus Express ing Spinach Defensin Proteins 2, 7 and 8 (GE CTV-SoD): Rationale for Not Conducting a Guideline Study- Acute Pulmonary Toxicity/ Pathogenicity", SGC-045. Author: V

. Forster 6 SGC-046 885

.3200 " Genetically Engineered Citrus tri steza virus Expressing Spinach Defensin Proteins 2, 7 and 8 (GE CTV-SoD): Rationale for Not Conducting a Guideline Study- Acute Injectio n Toxicity/Pathogenicity", SGC-046

. Author: V

. Forster 7 SGC-047 885.3400 "Ge netically Engineered Citrus tri steza virus Expressing Spinach Defensin Proteins 2, 7 and 8 (GE CTV-SoD) : Rationale for Not Conducting a Guideline Study- Hypersensitivity Incidents", SGC
-047. Author: V

. Forster 8 SGC-048 885.3500 "Ge netically Engine e red C itrus tri steza virus Exp ressi ng Spinach Defensin Proteins 2, 7 and 8 (GE CTV-SoD): Rationale for Not Conducting a Guideline Study- Cell Culture " , SGC-048

. Author: V. Forster 9 SGC-049 Non-Guideline "Ge netically Engineered Citrus tri steza virus Exp ress ing Spinach Defe nsin Protein 8 (GE CTVSoD8) : Rationale for Not Conducting a Digestibility Study in Simulated Gastric Fluid ", SGC-049

. Author: V

. Forster 10 SGC-040 Non -Gu ide lin e " Bioinformati cs Analysi s of Potential Allergenicity of D efensin Proteins 2, 7 and 8 from Spinach for use in Citrus Fruits " , SGC-040

. Author: R. Goodman 11 SGC-041 Non
-Guideline "B ioinformati cs Analys is of Potential Toxi ci ty of Defensin Proteins 2, 7 and 8 from Spinach for use in Citrus Fruits" , SGC-041. Author: R. GoodmanVolume No. Document No. Guideline No. Title MRID 12 SGC-042 Non-Guideline "Evaluation of the similarities of spinach defensin SoD8 compared to those of SoD2 and SoD7 proteins to estimate the digestibility of SoD8 for the safety assessment of genetically engineered crops", SGC-042. Author: 

### R. Goodman 13 SGC-050 885.4050 " Genetically Engineered Citrus tristeza virus Expressing Spinach Defensin Proteins 2, 7 and 8 (GE CTV-SoD): Rationale for Not Conducting a Guideline Study- Avian Oral , Tier 

### 1", SGC-050

. Author: V

. Forster 14 SGC-051 885.4100 "Genetically Engineered Citrus tristeza virus Expressing Spinach Defensi n Proteins 2 , 7 and 8 (GE CTV-SoD): Rationa le for Not Conducting a Guideline Study- Avian Inhalation Test , Tier 

### 1 ", SGC-051

. Author: V

. Forster 15 SGC-052 885.4150 "Genetically Engineered Citrus tristeza virus Expressing Spinach Defensin Proteins 2, 7 and 8 (GE CTV-SoD): Rationale for Not Conducting a Guideline Study- Wild Mammal Testing, Tier 

### 1 ", SGC-052

. Author: V. Forster 16 SGC-053 885.4200 "Genetically Engineered Citrus tri st

eza virus Expressing Spinach Defensin Proteins 2 , 7 and 8 (GE CTV-SoD): Rationale for Not Conducting a Guideline Study- Freshwater Fish Testing, Tier 

### 1 ", SGC-053

. Author: V

. Forster 17 SGC-054 885.4240 " Genetically Engineered Citrus tristeza virus Expressing Spinach Defensi n Proteins 2 , 7 and 8 (GE CTV-SoD): Rationale for Not Conducting a Guideline Study
- Freshwater Aquatic Invertebrate Testing " , SGC-054. Author: V. Forster 18 SGC-055 885.4280 "Genetically Engineered Citrus tri steza virus Expressing Sp inach Defensin Prote in s 2 , 7 and 8 (GE CTV-SoD) : Rationale for Not Conducting a Guideline Study- Estuarine and Marine Animal Testing ", SGC-055. Author: V. Forster 19 SGC
-056 885.4300 "Genetically Engineered Citrus tristeza virus Expressing Spinach Defensin Proteins 2 , 7 and 8 (GE CTV-SoD): Rationale for Not Conducting a Guideline Study- Non-Target Plant Studies , T ier 

### 1 ", SGC
-056. Author: V

. Forster 20 SGC-057 885.4340 " Genetically Engineered Citrus tristeza virus Expressing Spinach Defensin Prote i ns 2, 7 and 8 (GE CTV-SoD) : Rationale for Not Conducting a Guideline Study- Non-Target Insect Testing , Tier 

### 1 ", SGC-057. Author: V

. Forster 21 SGC-058 885.4380 " Genetically Engineered Citrus tristeza virus Expressing Spinach Defensin Proteins 2 , 7 and 8 (GE CTV-SoD) : Rationa le for Not Conductin g a Guideline Study- Honey Bee Testing, T ier 

### 1 ", SGC-058. Author: V

. ForsterSubmitter: Date : 

# u Ddnb.-v a 1..) Vickie Forster Authorized Representative for Southern Gardens Citrus Nursery, LLC
Company Name : Southern Gardens Citrus Company Contact: Vickie Forster (302-383-3313) forsterconsults@gmail .com