UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

WASHINGTON, D.C. 20460 

APR 3 0 2015 

Vickie Forster, Representative to SGC Nursery, LLC 

Southern Gardens Citrus, LLC 

1820 Country Road 833 

Clewiston, FL 33440 

OFFICE OF CHEMICAL SAFETY 

AND POLLUTION PREVENTION 

Subject: Plant Incorporated Protectant (PIP) with the Spinach defensin proteins (SoD2 and SoD7) 

and the genetic material necessary for their production when expressed in citrus plants. 

EPA Experimental Use Permit No. 88232-EUP-1 

Application Dated: June 6, 20 14 

Effective Dates: From the stamped date through April 18, 20 18 (i ncludes planting and associated 

activities e.g., coll ection of fie ld data, harvesting, processing). 

Quantity Authorized: 50 kg (in Florida) and 25 kg (in Texas) of active ingredi ent (see Table 4). 

Acres: 720 acres in Florida and Texas (600 PIP and 120 border) to test fo ur insertion events 

(SGC-41 1 08-7, SGC-41 332-6, SGC-11 3 19-8, and SGC-11 208-5) that produce two 

proteins (SoD2 and/or So0 7). 

Dear Ms. Forster: 

On the basis of the informati on furnished by the applicant, the U.S. Environmental Protection Agency 

(EPA) hereby issues the subject Experimental Use Permit (EUP) under section 5 of the Federal 

Insecticide, Fungicide, and Rodenticide Act to test the Plant Incorporated Protectant (PIP) with the 

spinach defensin proteins (So02 and So0 7) and the genetic material necessary for the ir production 

when expressed in citrus plants. The EUP is authori zed only in the States of Florida (FL) and Texas 

(TX). It allows evaluation of spinach defensin (SoD2 and SoD7) proteins in plant tissues, evaluation of 

compositional and nutritional data in raw and processed citrus commodities produced from each event, 

assessment of non-target organisms to disease resistant citrus, testing to determine the efficacy and 

specificity o f the transgenes, evaluati on of agronomic performance and optimization, production of 

sampl e material for environmenta l risk assessment, compositional studies and to test the commerc ial 

viability of experimental PIP events. 

Shipment and use under this permit are subj ect to the provisions of 40 CFR Part 172. The EPA reviewed 

the health and environmental safety of spinach defensin proteins and has determined that adverse effects 

are not expected to man and nontarget organisms, including federall y listed threatened and endangered 

species, as a result of the experiments to be performed under this EUP. A temporary tolerance 

exemption fo r the So0 2 and So07 spinach defensin proteins has been established concurrently with this 

EUP. 
Any pesticide treatments (e.g., herbicides) of the plants under the EUP must have applicable 

registrations. The Section G review of this EUP is enclosed (US EP A/BPPD review from K. Martin to 

K. Haymes, Ph.D., 03/31/15). 

Prior to shipment and/or use of the subject PIP spinach defensin proteins (So0 2 and So0 7) in citrus 

plants, you must consult with the pesti cide regulatory officials and, if applicable, the biotechnology 

regul atory officials of the States in which you will conduct your experimental program, and obtain a 

State permit or license if such is required. Issuance ofthis Federal permit does not negate the need for 

permission from individual States. Prior to initiating this experimental program in any State, you are 

required to notify the lead Agency of the States in which you will conduct your experimental program of 

the specific testing program (when, where, how much, etc.). Failure to do so may result in revocation or 

modification of this EUP. You must comply with all requirements of the USDA/APHIS as they apply to 

the proposed testing. 

You must provide notice to the State pesticide regulatory agency at least 72 hours before you initiate the 

EUP. You must also provide a copy of this authorization letter and stamped label, as we ll as the nonconfidential portion of the Section G Experimental Program, to all cooperators, participants and users 

prior to the initial pesticide use made in accordance with the EUP. The EPA will notify the relevant EPA 

Regions of the approval of this EUP by sending copies of this approval letter to them. 

The events, their expressed proteins, and the type of citrus included in this EUP are listed in Table I: 

Table 1: Events, Proteins, and Type of Citrus 

Event Protein Citrus Type 

SGC-41 I 08-7 So02 sweet orange 

SGC-4 1332-6 i So0 2, So07 sweet orange 

SGC-11 3 19-8 So0 2, So07 lemon 

SGC-11 208-5 So0 7 grapefruit '---

So0 2=Defensin 2; So0 7=Defensin 7 

The Conditions under whi ch the EPA is issuing this EUP are as follows: 

I. The total amount of acres Southern Gardens Citrus intends to plant is a maximum of 720 acres at 

test sites in Florida and Texas. The total acreage and amount of PIP plants to be used shall not 

exceed the quantity authorized by this EUP: 720 acres, including 600 Plant Incorporated 

Protectant and 120 maximum border acreage of control or other non-transformed citrus plants 

(see Table 2). The table shows the amount of plants per acres and the borders to be used in each 

state and in whi ch county. 

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Table 2: Summary of Acres by Event, Type (PIP, Border), and Location 

Hendry County, 

FL: 

Hidalgo County, 

TX: 

Total PIP: 

Total Border: 

SGC-41 1 08-7 

PIP Border 

100 20 

50 10 

150 

30 

SGC-41332-6 

PIP Border 

100 20 

50 10 

150 

30 

SGC-1 13 19-8 SGC-11208-5 

PIP Border PIP Border 

100 20 100 20 

50 10 50 10 

150 150 

30 30 

TOTAL 

PIP Border 

400 80 

200 40 

600 

120 

2. The following Table 3 shows the amount of protein (kg) that is expected for each event of the EUP 

study. The amount of protein was calculated by multiplying the acres by the planting density (i.e., 

trees/acre) by the amount of leaf material per tree (kg. dry weight) by the percent of active 

ingredient. Due to uncertainties regarding the measured concentration of SoD2 and SoD7 proteins 

Table 3 

in the leaf material, Southern Gardens Citrus proposed a conservative approach, where the maximum 

concentration measured (i.e., >20 mg/kg) was rounded up to 25 mg/kg and this value was used in the 

calculation for all four events. Under this scenario, the total amount of protein (kg) is expected to be 

75 kg; see Table 3 for the amount for each event and county. 

Amount of Protein Expected Assuming a Concentration of 25 mg/kg for Each Event 

Hendry County, 

FL: 

Hidalgo County, 

TX: 

Total: 

SOC41108-7 

12.5 

6.25 

18.75 

SOC41332-6 

12.5 

6.25 

18.75 

SOC- SOC- TOTAL 11 319-8 11 208-5 

12.5 12.5 50.0 

6.25 6.25 25.0 

18.75 18.75 75 .0 

3. Southern Gardens Citrus will immediately notify the EPA of any findings from the experimental 

uses that have a bearing on safety (i.e., EPA requires reporting of any adverse effects from the 

use of, or exposure to, the pesticide). Southern Gardens Citrus will also keep records of 

production, distribution and performance, and make the records available on request to any 

authorized officer or employee of the Environmental Protection Agency. 

4. Southern Gardens Citrus must provide a final report within 180 days of the expiration of the 

permit. The final report must include all of the items set forth in 40 CFR 172.8(b) and report on 

the fo llowing information: 

• A State-by-State breakdown of actual acreage per protocol 

• A State-by-State breakdown of actual locations per protocol 

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• Any changes to the stated program, including approved changes to study protocols and 

• A list of specific counties where studies took place 

5. Per 40 CFR 172.4(b)(v), Southern Gardens Citrus must provide to the EPA the name(s) and street 

address(es) of all cooperators as soon as available and prior to planting. Southern Gardens Citrus 

must record any changes to this information in an updated report and submit that report prior to 

planting. 

6. The label submitted in connection with this application is acceptabl e and must accompany all 

shipments of breeding material under this EUP subsequent to receiving this approval. Labels 

must also be in the possession ofthe user at the time of application. A stamped copy is enclosed 

for your records. 

7. This EUP is not a limited breeding registration under section 3 of FIFRA, and plantings solely 

for commerc ial breeding purposes are prohibited. 

8. Southern Gardens Citrus must follow the containment procedures described by Southern 

Gardens Citrus in the Section G submitted in support of the EUP (see MRID# 494093-03). 

Should you have questions or concerns regarding the issuance of this permit, please contact Dr. Kenneth 

Haymes, of the Biopestic ides and Pollution Prevention Division, by email at haymes.kenneth@epa.gov 

or by phone (703) 34 7-0398. 

Sincerely, 

Kimberly Nesci, Chi ef, Microbial Pesticides Branch 

Biopesticide and Pollution Prevention Division. 

Enclosures (stamped label and March 3 1, 2015 Section G review) 

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