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 spinach (spinacia o/eracea L.) 

(GE CTV-SoD). GE CTV-SoD is introduced into citrus trees or seedlings via grafting in 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 tristeza 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 materials 

and data reports in support of the above-referenced registration actions. 

Southern Gardens Citrus - Orange juice is our businessrM 

1820 CR 833 Clewiston, Florida 33440 Telephone: (863) 983-3030 Fax: (863) 902-4123 
This EUP will allow Southern Gardens to conduct larger field studies and collect data necessary 

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@gmail.com if you 

have any questions regarding this application. 

Sincerely, 

t)~ r;~ Vickie Forster 

Authorized Representative for Southern Gardens 

Citrus Nursery, LLC 

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

Southern Gardens Citrus- Orange juice is our businessTM 

1820 CR 833 Clewiston, Florida 33440 Telephone: (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 

MRID 
Volume No. Document No. Guideline No. Title MRID 

2 SGC-039 885.1100; "Product Characterization of Genetically 

885.1200; Engineered Citrus tristeza 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 tristeza 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 

Expressing 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 tristeza virus 

Expressing Spinach Defensin Proteins 2, 7 and 8 

(GE CTV-SoD): Rationale for Not Conducting a 

Guideline Study- Acute Injection 

Toxicity/Pathogenicity", SGC-046. Author: V. 

Forster 

7 SGC-047 885.3400 "Genetically Engineered Citrus tristeza 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 "Genetically Engineered Citrus tristeza virus 

Expressing 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 "Genetically Engineered Citrus tristeza virus 

Expressing Spinach Defensin Protein 8 (GE CTVSoD8): Rationale for Not Conducting a 

Digestibility Study in Simulated Gastric Fluid", 

SGC-049. Author: V. Forster 

10 SGC-040 Non-Guideline "Bioinformatics Analysis of Potential Allergenicity 

of Defensin Proteins 2, 7 and 8 from Spinach for 

use in Citrus Fruits ", SGC-040. Author: R. 

Goodman 

11 SGC-041 Non-Guideline "Bioinformatics Analysis of Potential Toxicity of 

Defensin Proteins 2, 7 and 8 from Spinach for use 

in Citrus Fruits", SGC-041. Author: R. Goodman 
Volume 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 Defensin Proteins 2, 7 and 8 

(GE CTV-SoD): Rationale 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 tristeza 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 Defensin 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 tristeza virus 

Expressing Spinach Defensin Proteins 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, Tier 

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

20 SGC-057 885.4340 "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 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): Rationale for Not Conducting a 

Guideline Study- Honey Bee Testing, Tier 1", 

SGC-058. Author: V. Forster 
Submitter: Date: u Ddn b.-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