1 EMERGENCY EXEMPTION REQUEST

(Specific Exemption)

FOR THE USE OF THE ANTIBIOTICS

FireWall TM 50WP Fungicide/Bactericide (streptomycin sulfate)

FireLine TM 17WP (oxytetracycline hydrochloride)

Mycoshield ® (oxytetracycline calcium)

TO SUPPRESS

Huanglongbing (HLB) ( Candidatus Liberibacter asiaticus)

and IMPROVE TREE HEALTH

ON

Citrus

IN FLORIDA

December 2, 20152 TABLE OF CONTENTS

CONTACT PERSON(S) AND QUALIFIED EXPERTS (166.20(a)(1)) .................... 3

DESCRIPTION OF PESTICIDE REQUESTED (166.20(a)(2)) .............................. 3

DESCRIPTION OF PROPOSED USE (166.20(a)(3)) ........................................... 4

ALTERNATIVE METHODS OF CONTROL (166.20(a)(4)) .................................. 12

EFFICACY OF USE PROPOSED UNDER SECTION 18 (166.20(a)(5)) ............... 17

DISCUSSION OF RESIDUES IN FOOD (166.20(a)(6)) .................................... 23

DISCUSSION OF RISK INFORMATION (166.20(a)(7)) ................................... 25

FQPA INFORMATION (OCTOBER 24, 1996 EPA LETTER) ................................. 31

COORDINATION WITH OTHER AFFECTED FEDERAL, STATE, AND LOCAL

AGENCIES (166.20(a)(8) ................................................................................. 31

NOTIFICATION OF REGISTRANT (166.20(a)(9)) ............................................ 31

DESCRIPTION OF ENFORCEMENT PROGRAM (166.20(a)(10)) ...................... 32

REPEAT USES (166.20(a)(11)) ........................................................................ 32

PROGRESS TOWARD REGISTRATION (166.20(b)(2)(ii)) ............................... 32

NAME OF PEST (166.20(b)(1)) ........................................................................ 33

DISCUSSION OF THE EMERGENCY CONDITION (166.20(b)(2)) .................... 33

DISCUSSION OF ECONOMIC LOSS (166.20(b)(4)) ......................................... 38

ESTIMATED REVENUES FOR TH E SITE TO BE TREATED (166.20(B)(4) ii & iii) ........................................................................................ 523 CONTACT PERSON(S) AND QUALIFIE D EXPERTS(S) (166.20(a)(1))

(i) The Contact Person for matters rela ting to the administration of this exemption:

Daniel A. Botts/Michael J. Aerts Charlie Clark, Environmental Admin. Florida Fruit & Vegetable Association FL Dept. of Ag and Consumer Services 800 Trafalgar Ct.; Suite 200 Pe sticide Registration Section
Post Office Box 948153 3125 Conner Blvd. (Bldg. 6) Maitland, FL 32794-8153 Tallahassee, FL 32399-1650 Phone: (321) 214-5200 Phone: (850) 617-7940 Fax: (321) 214-0210 Fax: (850) 617-7949 daniel.botts@ffva.com charlie.clark@freshfromflorida.com mike.aerts@ffva.com

(ii) The contact people for matters relating to the technical aspects of this exemption:

For Florida, it has been agr eed that questions relating to technical aspects in the field for this emergency exemption pe tition will work through the Florida Department of Agriculture and Consumer Services and the Emergency Response
Team within EPA’s OPP.

For other technical aspects related to this petition, the contact is:

Agrosource: Nufarm: Mark Trimmer Bill Bewlay Director; R&D Director, Business Development AgroSource, Inc. Nufarm Americas, Inc. 9889 Wilkinson Road 4020 Aerial Center Parkway, Suite 101 Mazomanie, WI 53560 Morrisville, NC 27560
Mobile: 608-628-2654 (919) 379-2506 Mark@TrimmerConsulting.com bill.bewlay@us.nufarm.com

DESCRIPTION OF PESTICIDE REQUESTED (166.20(a)(2))

a. Common Chemical Names (Active Ingredients):

Streptomycin Sulfate, Oxytetracyclin e Hydrochloride and Oxytetracycline
Calcium4 Trade Names and EPA Registration Numbers:

FireWall TM 50WP Fungicide/Bactericide EPA Registration Number: 80990-4

FireLine TM 17WP Fungicide/Bactericide EPA Registration Number: 80990-1

Mycoshield ® EPA Registration Number: 55146-97

Formulation:

All products are Wettable Powders

Percent Active Ingredient:

FireWall TM 50WP: 65.8% Streptomycin Sulf ate (equivalent to 50% streptomycin)

FireLine TM 17WP: 18.3% Oxytetracycline Hydrochloride (equivalent to 17% oxytetracycline) Mycoshield ® : 31.5% Oxytetracycline Calcium Complex (equivalent to 17% oxytetracycline)

Manufacturers:

FireWall TM and FireLine TM : AgroSource, Inc. Mycoshield ® : Nufarm Americas, Inc.

b. Additional labeling: see Appendix D (FireLine TM and FireWallTM) and Appendix E (Mycoshield®) for th e proposed Section 18 labels.

DESCRIPTION OF PROPOSED USE (166.20(a)(3))

(i) Site to be Treated:

Rationale for Multiple Active Ingredient Products:

The Citrus Research and De velopment Foundation, Inc. , (CRDF), a Florida based independent grower research support organi zation was created an d funded by grower assessments to guide the search for solutions to the recently introduced disease/vector complex Huanglongbing di sease/Asian citrus psyl lid. This research effort has proceeded across many fronts, one of which is the discovery and development of therapeutic treatments for infected trees. This program has directly participated in the funding of5 projects with registrants of agricultural anti biotics to determine th e role if any these compounds may provide in addressing this in dustry need. These pr ojects were initiated over the past twenty-four months and have pr ovided indications of value in maintaining the health and productive vigo r in citrus trees that are infected with the pathogen.

Initial experimentation and experience gained in commercial citrus groves with this disease/complex suggests that multiple bacteric ide applications will be necessary in order to improve tree health and suppress the effe cts of Huanglongbing (HLB) disease seasonlong/year-round on infected citrus trees. The information developed independently by the two registrants in cooperat ion with the Citrus Research and Development Foundation over the past two years indicates a measure of suppression and overall increase in tree
health in HLB-infected citrus trees. Each registrant developed their research package independently of the other’s involvement and the resultin g data indicates the three products have efficacy when used in a season long program targeted to the flush periods in citrus. The use patter ns of the oxytetracycline products, while somewhat complementary, were not base d on the same treatment regi mes. This petition has attempted to consolidate use patterns acro ss those treatment regimens and develop a package that would allow the fl exibility of the treatments pr oposed in each individual package. It is important to note that the re search program to refine and finalize final use patterns are on-going and will re sult in label expansion action s by each registrant. It must be recognized that while all of these products have ac tivity on other citrus plant pathogens, the reason for this petition is th e need for a th erapeutic treatment to prolong the life and viability of trees infected with HLB.

Additionally, the further rationale supporting th e use of multiple active ingredients for this particular Section 18 reques t include the following:

 The Candidatus Liberibacter asiaticus ( C Las) bacterium is a difficult organism to work with, starting with th e fact that this organism has never been successfully cultured in the laboratory. Its potentia l to develop resistance to antibacterial compounds applied for its control in the field is therefore unknown.

 Since C Las may develop resistance if treated wi th just a single bactericide product, an effective resistance management strategy must be part of any antibacterial HLB management program from the start.

 The heart of any effective resist ance management strategy against C Las will be
the use of at least two bact erial control agents, each having a unique mode of action against the pathogen.

 Based on their respective and unique mode s of action, streptomycin sulfate is classified as a Group 25 fungicide; oxyt etracycline is classi fied as a Group 41 fungicide according to the Fungicid e Resistance Action Committee (FRAC).6  The use of streptomycin and oxytetracyclin e in alternation will thus minimize any selection pressure on C Las for development of resistance to either streptomycin or oxytetracycline.

 Since both streptomycin and oxytetracyc line are individually efficacious against

C

Las in HLB-infected citrus, attacking the situation with these multiple products in
rotation constitutes an effective re sistance management program for HLB management and tree health improvement, thereby ensuring the long-term efficacy of these pr oducts against the C Las pathogen.

 This resistance management program should also help in preventing development of resistance in non-target bacteria as well.

All citrus (statewide) is the site to be trea ted. The proposed crop spectrum to be treated is slightly different for the two formulat ions of oxytetracyc line. The FireLine TM label and
FireWall TM label covers all of the Citrus Crop Group 10, whereas the Mycoshield ® label is proposing use on Orange, Crop Subgroup 10-10A and Grapef ruit, Crop Subgroup 10-10C. According to the latest figures available fr om the 2015 Citrus Reference Book (Florida Agricultural Statistics Service Citrus Summary, 2013 – 2014; February 2015), in 2014 there was a total of 515,147 acres of Flor ida commercial citrus acreage (452,364 acres oranges, 45,922 acres grapefruit, and 16,861 ac res specialty citrus). In a subsequent report (September 17, 2015), Th e National Agricultural St atistics Service reported 126,613 acres of abandoned or untended citr us acreage. This acreage would be
deducted from the above number resultin g in potentially treated acreage of 388,534 acres. See Appendix A for Florida counties and acreages in citrus.

(ii) Method of Application:

Ground application only.

(iii) Rates of Application (in te rms of a.i. and product):

FireWall TM 50WP 0.45 pounds active ingredient (a .i.) per acre per application 0.69 pounds of formulated FireWall TM 50WP per acre per application

FireLine TM 17WP 0.27 pounds of active ingredient (a.i.) per acre per application 1.5 pounds of formulated FireLine TM 17WP per acre per application Mycoshield ® 0.255 pounds of active ingredient (a.i.) (oxy tetracycline base) per acre per application 1.5 pounds of formulated Mycoshield ® per acre per application

Rates of application for Mycoshield ® are based on reaching a 200 ppm oxytetracycline (1.5 pounds of formulat ed product in 150 gallons of water)7 concentration in a finished spray volume necessary to fully cover the foliage of the tree to be treated. Spray vol ume and use rates per acre can be scaled downward in smaller trees depending on the amounts of spray volume to provide full coverage.

Maximum Number of Applications:

FireWall TM 50WP A maximum of 3 applications per year is proposed, totaling no more than 2.07 pounds of formulated FireWall TM 50WP per acre per year (1.35 pounds active ingredient). Allow a minimum of 21 days between applications.

Fireline TM 17WP A maximum of 3 applicatio ns of this formulation per year is proposed, totaling no more than 4.5 pounds of formulated FireLine TM 17WP per acre per year (0.81 pounds active ingredient). Allow a minimum of 21 days between applications.

Mycoshield ® A maximum of 8 applications per year is proposed, totaling no more than 12 pounds of formul ated Mycoshield ® per acre per year (2.04 pounds oxytetracycline base). Mycoshield ® would be labeled to suppress infections of HLB in foliage with a pplications beginning two w eeks after the initiation of a new leaf flush. Closer spra y intervals are conducive to better performance but limit the ability to us e the product on mu ltiple flushes. Wider spray intervals and fe wer applications on a gi ven flush may not be as effective but allows for more applicatio ns on successive fl ushes, especially in young small fram e citrus trees.

(iv) Total Acreage (or other units) to be Treated:

During 2013-14, approximately 515,147 acres of citrus were grown in Florida. Of this acreage 388, 534 acres remain under commercial management.

(v) Total Amount of Pesticide to be Us ed (in terms of a.i. and product):

FireWall TM 50WP
In an absolute worst-case scen ario, 804,265 pounds of formulated
FireWall TM 50WP Fungicide/Bactericide, or 695,448 pounds of streptomycin sulfate, would be need ed. (388,534 acres X 0.69 pounds of formulated
FireWall TM 50WP X 3 applications = 1,066,354 pounds FireWall TM 50WP Fungicide/Bactericide; 388,534 acres X 0.45 lbs. a.i. X 3 applications = 524,520 lbs. a.i. streptomycin sulfate).8 FireLine TM 17WP At the maximum, 1,748, 403 pounds of FireLine TM 17WP or 314,712 pounds of oxytetracycline hydrochloride, would be needed. (388,534 acres X 1.5 pounds of formulated FireLine TM 17WP X 3 applications = 1,748,403 pounds

FireLine TM 17WP; 388,534 acres X 0.27 poun ds a.i. X 3 applications = 314,712 pounds of oxytetracy cline hydrochloride).

Mycoshield ® The total amount of Mycoshield ® that could be used under the specific exemption assuming all trees ar e treated the maximum number of recommended applications would be a total of 4,662,408 pounds of formulated Mycoshield ® or 762,309 pounds of oxyt etracycline calcium. (388,534 acres X 1.5 po unds of Mycoshield ® X 8 applications = 4,662,408 pounds of Mycoshield ® ; 388,534 acres X 0.255 pounds oxytetracycline base X 8 applications = 762,309 pounds of ox ytetracycline base ). While the use of Mycoshield® is limited to citrus crop subgroups 10 A and 10 C, the members of crop subgroup 10B (lim es and lemons) represent less than 2,000 acres of production in Florid a (less than 2,550 lbs of active ingredient.

Note Oxytetracycline Formulations:

Across the two formulations of oxytet racycline, the tota l amount of the active ingredient oxytetracycline that would be allowed under the proposed use patterns included in th is petition is equivalent to the maximum amount of active ingredient that could be ap plied per individual acre of treated citrus under the proposed Mycoshield ® Section 18 label plus the amount adjusted for the three applications on Citrus Subgroup B, which is allowed on the proposed FireLineTM 17 Sectio n 18 label (0.81lbs X 2,000 Acres of lemons and limes = 1,620 lbs). This is (762,309 lbs. – (2,550 lbs. (5 applications at .255 lbs. )) = 759,759 lbs. of oxytet racycline. The use across the two formulated products (on Citrus Subgoups 10 A and 10 C)
would be additive over the season an d capped at the maximum level of active ingredient per acre of 2.04 lbs. of oxytetracy cline for Citrus Subgroups A & C and 0.81lbs. on Citrus Subgroup B. We would encourage the Agency in their deci sion document to clearl y state that the maximum amount of oxytetracycline per acre per season is capped so that if growers choose to use both produc ts they do not exceed th e maximum per acre use
allowed.

While the amounts of product that could be needed is proj ected above; it is highly probable that not all of the eligible acreage w ill be treated, and a portion of the treated acreage will be treated at lower use rates than the
maximum rate because of sm aller canopy size in th e younger age classes of9 trees. This will result in less mate rial being used than the numbers projected above.

(vi) Use Season (period of time fo r which use of chemical is requested):

Access would be needed by February 1, 2016, to coincide and overlap with the typical spring foliage flush emerge nce. Availability subsequent to the date of approval is requested and crucial over the en suing 12 months, especially when consider ing the continued infection rates and subsequent tree losses resulting from HLB disease.

FireWall TM 50WP
FireWall TM 50WP will be applied to all varieties and cult ivars included in the Citrus Crop Group 10. Make an initial ap plication at initiati on of spring flush to suppress HLB titer and disease symp toms. Make a second application mid-summer (not less than 21 days af ter first application). Make a third application in late summer to redu ce the incidence of HLB-induced fruit drop and to further suppress HLB titer and disease symptoms (not less than 21 days after second application). Spra y to near runoff. Applications of
FireWall TM 50WP should be rotated with anot her bactericidal product having a different mode of action, to reduce risks of selecting for streptomycinresistant organisms.

FireLine TM 17WP
FireLine TM 17WP will be applied to all varieties and cult ivars included in the Citrus Crop Group 10. Make an initial ap plication at initiati on of spring flush to suppress HLB titer and disease symp toms. Make a second application mid-summer (not less than 21 days af ter first application). Make a third application in late summer to redu ce the incidence of HLB-induced fruit drop and to further suppress HLB titer and disease symptoms (not less than 21 days after second application) . Spray to near runoff.

Mycoshield ®

The recommendation is to make 3 to 4 applications to growth flushes in the spring and fall. Applicat ions to the spring flush could be initiated in February through April depending on th e citrus variety and the severity of the winter. It may take until the end of May to complete the entire application program on the spring fl ush. Fall flushes would consist of periods of new growth initiating after September 1 st

.

Foliar applications of these antibiotic s are not expected to cure systemic
infections of HLB in the branches, trunks or roots of a diseased tree. Application flexibility is needed so growers can target periods of disease10 suppression and relief of associated symptoms that best fit their overall production program.

(vii) Additional Restrictions, User Precautions and Requirements, Qualifications of Applicators, etc.:

All active ingredients w ill be applied in accordance with the proposed Section 18 label and all applicable prov isions of the Section 3 registered labels. Examples of various restrict ions, requirements and qualifications
include but are not limited to:

FireWall TM 50WP

 A total of three (3) applications of FireWall TM 50WP may be made at no less than 21 day intervals.

 Do not apply at less than 40 days prior to harvest.

 Do not apply through irrigati on systems or by aircraft.

 Do not apply more th an 2.07 pounds of formulated FireWall TM 50WP (1.35 pounds active ingredient) per acre.

 Personal protective equipment for ap plicators and handlers includes:

o Long sleeved shirt

o Long pants

o Chemical resistant gloves made of a waterproof material

o Shoes plus socks

o Protective eyewear

o MSHA/NIOSH approved dust/mist re spirator with any N, R, P or
HE filter.

 Worker re-entry into treated areas duri ng the restricted entry interval of 12 hours is not allowed. For early entry to treated areas that is permitted under the Worker Protect ion Standard and that involves contact with anything that has been treated, such as plants, soil or water, wear:

o Coveralls over long-sleev ed shirt and long pants

o Chemical-resistant gloves made of a waterproof material

o Shoes plus socks

o Protective eyewear.

 Do not apply directly to water, to areas where surface water is present
or to intertidal areas below the mean high water mark.

 Do not contaminate water by cleani ng of equipment or disposal of equipment washwater.

 The FireWall TM 50WP label contains a CAUTIO N statement of hazard and this product is consider ed to be a “General Us e” pesticide. As a nonrestricted pesticide, farmers withou t private applicator certification,11 farmers with private applicator ce rtification, and licensed commercial applicators are allowed to apply FireWall TM 50WP.

FireLine TM 17WP

 A total of three (3) applications of FireLine TM 17WP may be made at no less than 21 day intervals.

 Do not apply at less than 40 days prior to harvest.

 Do not apply through irrigati on systems or by aircraft.

 Do not apply more than 4.5 po unds of formulated FireLine TM 17WP (0.81 pounds active ingredient) per acre.

 Personal protective equipment for ap plicators and handlers includes:

o Long sleeved shir t and long pants

o Chemical resistant gloves made of a waterproof material

o Shoes plus socks

o Protective eyewear

o Dust/mist filtering respirator (MSHA/NIOSH approval number prefix TC -21C) or a NIOSH approve d respirator with any N , R, P
or HE filter.

 Worker re-entry into treated areas duri ng the restricted entry interval of 12 hours is not allowed. For early entry to treated areas that is permitted under the Worker Protect ion Standard and that involves contact with anything that has been treated, such as plants, soil or water, wear:

o Coveralls over long-sleev ed shirt and long pants

o Chemical-resistant gloves made of a waterproof material

o Shoes plus socks

o Protective eyewear.

 Do not apply directly to water, to areas where surface water is present
or to intertidal areas below the mean high water mark.

 Do not contaminate water by cleani ng of equipment or disposal of equipment washwater.

 The FireLine TM 17WP label contains a CAUTIO N statement of hazard and this product is consider ed to be a “General Us e” pesticide. As a nonrestricted pesticide, farmers withou t private applicator certification, farmers with private applicator ce rtification, and licensed commercial applicators are allowed to apply FireLine TM 17WP.

Mycoshield ®

 A total of eight (8) applications of Mycoshield ® may be made at no less than 21 day intervals.

 Do not apply at less than 21 days prior to harvest.

 Do not apply through irrigati on systems or by aircraft.12  Do not apply more th an 12.0 pounds of fo rmulated Mycoshield ®
(2.04 pounds oxytetracycline base) per acre.

 Personal protective equipment for ap plicators and handlers includes:

 Long sleeved shirt.

 Long pants.

 Chemical resistant gloves made of a waterproof material.

 Shoes plus socks.

 Protective eyewear.

 Dust/Mist filtering respirator (MSH A/NIOSH approval number prefix TC-21C) or a NIOSH approved respirator with any N, R, P or HE
filter.

 Worker re-entry into treated areas du ring the restricted entry interval
of 12 hours is not allowed. For earl y entry to treated areas that is permitted under the Worker Protect ion Standard and that involves contact with anything that has been treated, such as plants, soil or water, wear:

o Coveralls over long-sleev ed shirt and long pants

o Chemical-resistant gloves made of a waterproof material

o Shoes plus socks

o Protective eyewear.

 Do not apply directly to water, to areas where surface water is present or to intertidal areas be low the mean high water mark.

 Do not contaminate water by cleani ng of equipment or disposal of equipment washwater.

 The Mycoshield ® label contains a WARNING statement of hazard and this product is consider ed to be a “General Us e” pesticide. As a nonrestricted pesticide, farmers withou t private applicator certification, farmers with private applicator ce rtification and licensed commercial applicators are allowed to apply Mycoshield ®

.

Other specific use directio ns to be followed are found on the proposed
Section 18 labels and the Section 3 la bels found in Appe ndices D and E.

ALTERNATIVE METHODS OF CONTROL (166.20(a)(4) ):

(i) Detailed Explanation of Why Currently Registered Pesticides Are Not Available in Adequate Supply and/ or Are Not Effective to Control the Emergency:

The Huanglongbing (HLB) diseas e/vector complex and its impa ct on the industry have been rapidly increasing since th e disease was first identified in Florida in August of 2005. The fact that HLB was on the U.S. Department of Homeland Security ’s Select Agent List made field work next to impossible until that status was modified. As experience with the disease has progressed, it has become apparent that managing the disease at levels that13 will allow continued commercia l production in Florida de pends on a multifaceted management strategy. This strategy includes the ability to replac e non-productive trees with a realistic expectation that the ne wly planted replacement trees will have a reasonably productive life. Even with the complexities crea ted by the lack of ability to
culture the bacteria outside of the citrus vascular system an d the digestive system of the insect, the industry has made significant strides in identi fying the critical components of this management process.

From the beginning, there ha ve been a range of approach es attempted to manage the
devastation that HLB has caused to Florid a citrus, and the pursuit of many parallel strategies continues. Challeng es of managing HLB disease in Florida citrus are many and the application of tools that are available and emerging from research have yet to provide for a sustained leveling of disea se impact or to restore tree health and productivity to trees infected with the pathog en. The graphic below highli ghts the breadth of effort underway in research to discover, test and deliver solutions to HLB, identifying the primary targets for interventi on. Vector control, combin ed with therapy to reduce C Las titers (bacterial concentrations) in infected trees and ultimately, de ployment of resistant or tolerant plant materials offers the ba lanced approach to disease management.
Because of the absence of effect ive tools for bacteria l therapy (the basis for this petition) and no proven plant r esistance, the disease continues to im pact all Florida growers and is discouraging the much-needed replanting to complement the current struggling tree inventory.

From the outset, it has been clear that vector control wa s tantamount to slow the spread of the disease, and many strate gies were advanced to achiev e this goal. Insecticidal suppression, biological control, attractant s and repellants and ot her approaches have14 been pursued, and as a result, Asian citrus psyllid (ACP) popu lations are well below initial levels. Similarly, as C Las infection spread and the nu mbers of infected trees grew, expansion of ACP control was necessary to pr otect new plants in ex isting groves and new plantings from becoming infected. Soil-applied neonicot inoid insecticides play a major role in protecting young trees during critical periods as th ey grow through the first 5 years, and these insecticides become more important as the disease reservoirs of inoculum and vector populations continue to expand. ACP suppression remains a critical component of HLB management with research and grower experience continuing to
demonstrate the value of this segment of HLB management.

Florida citrus growers realized early that su staining plant health through horticultural practices was an important re sponse to onset and advancem ent of HLB disease. While trees possess considerable resilience in respon se to stresses, a chronically declining tree loses much of its resilience, and therefore must be managed more carefully. “Just-intime inputs” or “spoon-feedin g” trees showing advanced HL B symptoms with irrigation and fertilization can dampen limitations of compromised root systems, and cultural practices have been modified to more intensively manage tr ee health. In addition, plant growth regulators are being evaluated and us ed in an effort to assist in phloem regeneration and to limit pre- harvest fruit drop associated with HLB decline. Other cultural practices are being investigated to sustain health and prod uctivity of infected trees and perhaps prolong produc tive life of these trees. So me of these same practices of intensive management are likewise being applied to newly planted trees to meet the goal of accelerating tree grow th and maturity, thereby allo wing for economic return to growers before HLB-induced tree decline commences. Howe ver, consistent success in
this effort remains elusive.

Neither vector suppression nor cultural practices directly im pact the bacterial pathogen,

C

Las, which is the target of the inte rvention proposed in this petition.

The goal of reducing C Las titer in infected trees ha s proven quite challenging, and relatively little progress has been made in th is arena. The locati on of the pathogen within the plant’s vascular system , difficulty of early detection of infection in citrus plants, and the inability of researchers to wo rk with cultures of the bacteria C Las have limited development of C Las therapies to two strategies.

The first of these strategies is application of thermal therapy, where external heat is applied actively or passively to infected trees to differentially cause bacterial mortality in phloem tissues, while not harming the host plant tissues. The differential time versus temperature requirements to achieve this goal are being pursued through research and field experimentation on commercial farms.

The alternative to thermal th erapy is the application of chemical therapy, wherein
bactericidal chemicals are applied to trees to reduce C Las bacterial titer. This approach has been a priority focus fo r industry research efforts and extensive investment in evaluating efficacy, dose re sponse, phytotoxicity and other parameters important to15 development of a therapy tool. Chemical therapy encompasses a range of chemistries that correspond to various regulatory pathways , from conventional agricultural antibiotics to biopesticides to new active ingredients. Chemistries that fall within currently registered pesticides, 25(b) exempt list, or biopesticides offer the shorter term opportunities and these are being pursued a ggressively while long er term new active ingredients are developed. Ou r strategy has focuse d most aggressively on agricultural antibiotics as these products offer an opportuni ty for label expansion from other U.S. crop uses as bactericides, and for which ther e is a broad pool of supporting data.

Processes in place to evaluate chem ical therapy candidates include:

 A comprehensive laboratory bioassay system progressing from a high throughput surrogate bacterial assay to whole plant greenhouse assays;

 A range of field research spanning sing le plant initial trials to large scale
commercial trials conducted in concert with registrants;

 Efficacy as a function of a.i., dose, timing, application method and disease intensity has been evaluated, as well as phytotoxicity, movement within the plant, and residues in plant parts.

Finally, several long-term lines of technology are being developed to identify and move the genetic components necessary to convey resistance into hort iculturally important
citrus cultivars. Field trials have been initiated to further in vestigate the potential for this to serve as a long-term means of restoring the viability of the industry. But, results are still expected to be years off.

All of this work in the state of Florida is being coordinate d through the Citrus Research and Development Foundation (CRDF). This pr ogram of research to develop and deliver
HLB solutions is also coordinated with exis ting national and in ternational programs through USDA ARS, other resear ch institutions, and, industry associations in Texas and
California.

(ii) Alternative Control Practices:

Alternative C Las therapy/suppression practices are ou tlined above and ar e restricted at present to thermal therapy an d chemical therapy. While there are other approaches
mentioned above for vector or plant health management, none of these address reducing

C

Las titer in infected trees, an d these tools are not likely to affect decline of infected

trees.

Thermal therapy:

Some success has been observed with applicatio n of passive solar ener gy or active steam heat to young trees. These fi eld demonstrations and trials have been evolving since the16 spring of 2014, when proof of concept was completed with so larization inside single-tree tents. Early attempts with bo th passive and active thermal treatment resulted in severe tree injury or actual tree death, leading to subsequent investigations to define time/temperature relationships and method s of delivery to achi eve the differential thermal effects on bacteria while preventi ng tree injury. At present, all systems operating in the field to advan ce this approach are designed to treat in dividual trees up to a maximum height of about 3 meters. Results appear most predictable when trees are in early stage in infection and diseas e onset. While delivery systems and time/temperature characteristics are being resolved, predictabili ty of response and expected duration of e ffects are in early stages of evalua tion. Practical limitations of the
number of trees that can be treated with th ermal therapy and the ex pected outcomes in balancing bacterial titer reduct ion with increasing injury to leaves, limbs and fruit on treated trees are being evaluate d in small-scale field trials in Florida. Research and commercialization funding is encouraging innovation to solve issues of practical application of this C Las suppression strategy, but progre ss is slow at present. It is anticipated that this approach will emerge on a commercial scale as a tool for managing early infection that will perhaps be limited to yo ung (small) trees.

Chemical Therapy of C Las:

Chemical therapy of C Las is under intensive investigation in Florida citrus, with relatively
few candidate materials advanced to commercial use or demons trated effectiveness. The only antibiotics available fo r use in the agricultural s ector include streptomycin, oxytetracycline and kasugamycin. Among the groups of chem istries under consideration, the bactericides labelled for use in other crop s are the front-runners in terms of available data and performance testing in Florida citrus. These are th e subjects for this Emergency Exemption petition.

Alternatives available for field use against C Las are few. C Las bioassay and field trials are being conducted on the biopestici des that are labelled for pest or disease control in citrus
to determine how effective th ese materials might be under current field use patterns. Field research is ongoing, but results that could indicate a clear effect are not yet available. Optimism around these products exists but none of these materials are currently considered as demonstrable C Las therapy.

Other alternative chemistries that are be ing evaluated in Florida citrus for HLB suppression or tree health management includ e products based on plant essential oils. Some of these oils appear on the EPA 25(b) exempt list. Several products containing plant essential oils are available in Florida [e.g., Thymeguard (Agr oResearch), and Ecotrol Plus (Keyplex ® )]. These products are being field ev aluated by growers to determine their impact on HLB through foliar application.

Field trials are underway to quantify the impact of these po tential tools, but it is too early to have meaningful results. Similarly, field evaluations by Florida gr owers in conventional and organic citrus blocks have failed to demonstrate a measur able effect of these plant17 essential oils. While these t ools may complement the bacter icides being considered in this petition, there is limi ted evidence for their effect iveness in reversing HLB.

EFFECTIVENESS OF USE PROPOSED UNDER SECTION 18 (166.20(a)(5)) (166.20(a)(5))

FireWall TM 50WP and FireLine TM 17WP

To assess the potential management of HL B disease, foliar applications of two bactericides, streptomycin sulfate and oxyt etracycline hydrochloride were applied to commercially-grown grapefruit and oranges at 17 Florida fiel d test locations in 2014 (year 1) and 2015 (year 2). Trials were located in the Indian River, th e Central Ridge and the Peace River regions of Florida’s citrus industry . Prior to treatment applications, all trees
at each location were confirmed to test “positive” for HLB, based on PCR (polymerase chain reaction) analysis. Treatment eff ects for streptomycin and oxytetracycline applications were determined by quarte rly DNA titer assays of the bacterium Candidatus Liberibacter asiaticus present in leaf sample s collected from each treatment plot. In addition, multiple assessments of tree health were made, including improvement in tree canopy density (e.g. health), increased tree heig ht and reductions in leaf drop, fruit drop, visual HLB symptoms, branch dieback and increases in fruit load in treated versus untreated trees. Foliar applications with strept omycin or oxytetracycline to grapefruit and orange trees in year-1 result ed in a statistically signific ant reduction (p < 0.05) in C Las titer, and this remained eviden t 4 to 5 months after the last application of streptomycin or oxytetracycline. In addition, significan t improvements (p < 0.05) in leaf drop, fruit drop, visual HLB symptoms, and visual tree he alth, were noted in treated year-1 trees. Significant treatment effects (p < 0.05) were also recorded for these same parameters plus tree height in year-2. Re sults from these trials showed that foliar applications of streptomycin and oxytetracyclin e bactericides to commercially grown citrus significantly
reduces titer for C Las in HLB-infected trees, and result s in significant improvements to
overall tree health. These field evaluations serve to illustrate th at the reduction in C Las
titer from the PCR results has correlation to healthier citrus trees in a production grove

environment.

Mycoshield ®

Mycoshield ® oxytetracycline calcium complex was fi rst registered in 1979 for control of fire blight ( Erwinia amylovora ) of pear and bacterial spot ( Xanthomonas arboricola pv. pruni ) of peach. Apple (fire blig ht) and nectarine (bacterial sp ot) were added to the label in later years. Oxytetracyc line hydrochloride was first appr oved for agricultural use in 2004. EPA has determined that oxytetracy cline calcium complex and oxytetracycline hydrochloride rapidly convert to oxytetracy cline when added to water and “both OTC calcium complex and OTC-HCL will be mainly in troduced into the environment as OTC.” Thus, it was determined that environmental fate data for OTC calcium complex and OTC-18 HCL are interchangeable. Disease control with the two forms is expected to be equivalent because the spray deposits would be oxytetracycline.

Oxytetracycline is pr oduced naturally by Streptomyces rimosus . Commercial production of Mycoshield ® is achieved by fermentati on of the natural organism . This is followed by
an extraction and concentratio n process to obtain a manufac turing concentrate that is used to make the final end prod uct. OTC is a reversible bact eriostat that i nhibits protein synthesis at the ribosome. Su sceptible bacteria may resume development if the exposure period is inadequate for acti on by a secondary mortality factor such as senescence, attempted cell division, en vironmental stress or a ho st plant response.

Potted seedlings of various ci trus cultivars were sprayed to run off with daily foliar applications of oxytetracycline at 100 ppm in a 1975 report (A. L. Martinez, 1975). A majority of the plants demons trated partial recovery with obvious improvements in color and shoot production. However, none of the pl ants were completely cu red. Injections of tetracycline to Sakkan orange and Fuju mandarin at 500 to 1000 ppm were effective at reducing disease symptoms an d preserving higher yields in a 1991 article (K. Chung and W. Zhisheng, 1991). The trees were not cured and growth of the disease was evident one year later. Injection of tetracycline re sulted in phytotoxic effects such as rotten tissue around the injection poin ts and leaf drop. Oxytetracy cline was not considered to be of value in the early stages of the Florid a epidemic because of the inability to cure
infected trees.

The following characteristics are required for bactericides to make definitive claims for direct suppressive activity on HLB and have practical utility fo r use in the field:

1. Proven activity on Liberibacter spp. in culture . It must inhibit Candidatus Liberbacter crescens, the clos est cultured relative of Candidatus Liberibacter asiaticus, at low concentrations. Oxytetracycline strongly inhibits Candidatus
Liberbacter crescens culture growth by more than 90 percent at a concentration of

0.54 μ M, a level suitable for fiel d use. Thus, it is believ ed that oxytetracycline can
inhibit Candidatus Liberbacter asiaticus

.

2. Phloem mobility . The chemical structure of oxyt etracycline suggests that it can penetrate the phloem wh ere the causal agent, Candidatus Liberibacter asiaticus,
resides in the tree.

3. Excellent crop safety . Mycoshield ® applied twice weekly to citrus at 1000 ppm for 12 weeks (24 total applications) did no t cause noticeable in jury in a 2013 field trial by the University of Florida’s Dr. Eric Triplett (personal communication).

Zebra chip disease is caused by Candidatus Liberibacter solanacearum, a very close
relative of Candidatus Liberbacter asiaticus. As in HLB disease, the Liberibacter pathogen resides in the phloem after having been vectored by a phloem-feeding insect (potato psyllid). Testing bactericides against zebra chip disease on tomato or potato generates19 results much faster than can be obtained on citrus. Symp toms on tomato appear in 10 days but can take many months on citrus. Disease suppression th rough the use of an
effective bactericide can be ob served in less than three weeks in to mato but can take many months on citrus.

Zebra chip is not endemic to Florida, but laboratory and fi eld research ca n be conducted in south Texas where the disease and potato psyllid are widely esta blished. Dr. Erik Mirkov (Texas A&M AgriLife Research) has shown in laboratory studies that oxytetracycline effectively ma nages the symptoms of Zebra chip disease on tomato and dramatically reduces the number of bacteria residing in the plant (data in preparation for publication). Dr. Manuel Campos (Texas A& M AgriLife Research) conducted a field trial on potato in 2015. Five week ly applications of Mycoshield ® at 200 ppm resulted in 13 percent infected tubers as compared to 90 percent in the unt reated. This study demonstrated that oxytetracycline can redu ce disease caused by a phloem-limited pathogen very closely related to Candidatus Liberbacter asiaticus.

Nufarm conducted experimental field tria ls in 2014 and 2015 (Better Crops, LLC, 2014 / 2015) evaluating the suppressi ve activity of Mycoshield ® foliar sprays against HLB in Florida groves with HLB symptoms. This wa s a commercial grapefru it grove with 7 – 10 year old trees.

In 2014, the treatment list was based on anecdotal informatio n suggesting that a
combination of a bactericide with a strong penetrant (Pentra-Bark ® ) plus fertilizers would provide the best results. Unfortunat ely, the treatments with Pentra-Bark ® /fertilizer combinations (with or without a bactericide) resulted in phytot oxic effects in the form of severe leaf and fruit drop. Although 2014 growth informat ion was confounded by the crop injury, qPCR data demonstrated that ox ytetracycline foliar applications suppressed
the incidence of HLB infection in new growth. Samples of ma ture foliage collected prior to the initiation of the pr ogram revealed an infection incidence of 75 – 100 percent throughout the study area. Samples of mature foliage co llected after the treatment program (4 applications at 3 week intervals) had the same inciden ce of infection.

However, samples of new foliag e that was flushing during the treatment period showed that all Mycoshield ® foliar treatments (treatments 6 – 12) only had an infection incidence of 25 – 50 percent. The untreated, fertilizer + Pentra-Bark ® alone, Agri-Mycin ® 17 streptomycin (with and without Pentra-Bark ® ) and Mycoshield ® trunk spray had an
infection incidence of 50 – 75 percent.20 Table 1: Mycoshield ® HLB Foliar Suppression - Grapefruit - St. Lucie W 2014 Percent of Plots Positive for HLB / Old vs. New Foliage

Treatment % Old Infect 7-27 % Old Infect 10-29 % New Infect 10-29

Untreated 75 75 75 Fertilizer (F) + Pentra-Bark ® (P) 75 75 50 Agri-Mycin ® Low Vol (AL) 100 100 50

AL + P 100 100 75 Mycoshield ® + P Trunk 75 75 50 Mycoshield ® Low Vol (ML) 100 100 25

ML + P 75 75 50 Mycoshield ® High Vol (MH) + P 75 75 25

ML + F + P 100 100 25

MH + F + P 100 100 25

MH + RTREX Plus 100 100 25 MH + KeyPlex ® 1400 DP 100 100 25

Antibiotic Foliar and Trunk Applications: 7-27, 8-15, 9-12, 10-11 Fertilizer Foliar Application: 7-27, 9-12 Fertilizer: 1 gal chelated iron + 5 lb. zinc sulfate + 5 lb. manganese sulfate / A Agri-Mycin ® 17 and Mycoshield ® Low Vol: 1.5 lb. product in 100 GPA Mycoshield ® High Vol: 1.5 lb. product in 150 GPA Mycoshield ® Trunk: 1.5 lb. in 12.5 GPA @ approximately 8 oz./tree
Pentra-Bark ® : Applied at 0.5% v/v foliar; 2.5% v/v trunk Infection Incidence: % of plots testing positive for HLB based on PCR of old or young foliage

Table 2: Mycoshield ® HLB Foliar Suppression - Grapefruit - St. Lucie W 2014 Percent of Tree Canopy a Contiguous Leaf Wall

Treatment % leaf Wall Area 3-31-2015

Untreated 49 b Fertilizer (F) + Pentra-Bark ® (P) 48 b Agri-Mycin ® Low Vol (AL) 53 ab

AL + P 67 a Mycoshield ® + P Trunk 59 ab Mycoshield ® Low Vol (ML) 69 a

ML + P 67 a Mycoshield ® High Vol (MH) + P 71 a

ML + F + P 63 ab

MH + F + P 64 ab

MH + RTREX Plus 58 ab MH + KeyPlex ® 1400 DP 58 ab

Percent Leaf Wall: Visual assessm ent of canopy fullness averaged for 4 angles of perspective on
each tree.

The 2014 study area recovered from the phytotox icity and increased sp ring growth of the new canopy in 2015 was evident in all oxytetracycline foliar treatments relative to the untreated (9 – 22% denser canopy than the un treated). Several of the treatments were significantly superior to the un treated (5% probability level).21 Table 3: Mycoshield ® HLB Foliar Suppression /Grapefruit - St. Lucie W 2015

Treatment Vigor Rating 7-21-2015
Untreated 5.2 c Mycoshield ® + Pentra-Bark ® Trunk 5.5 bc

Phostrol ® 4.5pt/100 gal 5.5 bc Mycoshield ® LV 5.6 bc Mycoshield ® HV 6.8 abc Mycoshield ® + Phostrol ® LV 6.3 abc Mycoshield ® + Tactic ® 0.125% LV 6.7 abc Mycoshield ® + Tactic ® 0.125% HV 6.2 abc Mycoshield ® + Tactic ® 0.125% LV 4 appl* 6.8 abc Mycoshield ® + Dyne-Amic ® 0.25% LV 5.7 bc Mycoshield ® + Dyne-Amic ® 0.25% HV 6.2 abc Mycoshield ® + LI 700 0.25% LV 7.1 ab Mycoshield ® + LI 700 0.25% LV 7.7 a

Three applications to spring 2015 flush @ 2 week intervals

* A 4 th application made 6 days after the 3 rd Mycoshield ® Low Vol: 1.0 lb. product in 100 GPA
Phostrol ® Low Vol: 4.5 pints in 100 GPA Mycoshield ® High Vol: 1.5 lb. product in 150 GPA Mycoshield ® Trunk: 1.5 lb. in 12.5 GPA @ approximately 8 ounces per tree
Pentra-Bark ® : Applied at 0.5% v/v foliar; 2.5% v/v trunk Tree Vigor Rating: 0 = dead; 10 = completely healthy growth

The 2015 grapefruit study was es tablished on different trees. Application timing focused on periods of new growth flush in the spri ng, summer and fall. Pe riods of new growth are the optimal time s for infection by C Las and it was expected that phloem penetration of oxytetracycline would o ccur at a greater concentrat ion in newer foliage. Many of the treatments invol ved the identification of a dditives that would improve performance without causing crop injury an d the comparison of two spray volumes (100 and 150 gal/acre). Most trea tments involved three applicat ions at two week intervals initiated at a flush of new growth. Approx imately six weeks after flush initiation, the foliage hardens, becomes less a ttractive to psyllid feeding and is less amenable to the penetration of oxytetracy cline. One tank mix treatment of Mycoshield ® + Tactic included a fourth spray applied six days after the thir d application. A trunk spray of Mycoshield ®

+ Pentra-Bark ® was added as a comparison with the foliar sprays which were applied to the point of runoff. Mid-season tree vigor ratings (0 – 10 scal e) showed that all oxytetracycline foliar treatmen ts were numerically higher th an the untreated, trunk spray
and Phostrol ® alone. The mixt ure of Mycoshield ® + LI 700 at 100 and 150 gal/acre was significantly superior to the untreated (5% probability level). Oxytetracycline degrades quicker at a neutral pH than und er acidic conditions . LI 700 is an acid ifying penetrating surfactant which may be stabi lizing the applied residues and extending the period for leaf absorption.

Leaves were collected from selected trea tments in the 2015 gr apefruit trial and forwarded to Dr. Xiaoan Sun (F lorida Department of Agriculture and Consumer Services,22 Division of Plant Industry) fo r residue analysis. Dr. Sun us es a method that has a lower limit of quantification (1 ppm). Values lowe r than this may represen t false detects. The analysis proved that oxytetracy cline penetrated the foliage an d was still detectable in the single treatment that was collect ed four days after application. As predicted the residues were higher in young leaves than old leaves. However, ox ytetracycline wa s not found at the limit of quantification in leaves at 10 days after applic ation. The grapefruit leaf residue analysis supports that the application needs to be less than 10 days to prevent
HLB bacteria from recoveri ng and resuming growth.

Table 4: Mycoshield ® - Grapefruit Leaf Residues 2015

Treatment Additive # Appl Last Appl Sampled Foliage Residues (ppm)

Mature New Untreated none 0 NA 22 May ND – all Reps ND, 0.5 Mycoshield ® Foliar 1.0 lb./100 GPA none 3 12 May 22 May ND – all Reps ND, 0.5 Mycoshield ® Foliar 1.5 lb./100 GPA none 3 12 May 22 May ND – all Reps ND, 0.7

Phostrol ® Foliar 4.5 pt./100 GPA none 3 12 May 22 May ND – all Reps ND – all Reps Mycoshield ® + Phostrol ® /100 GPA none 3 12 May 22 May ND – all Reps ND – all Reps Mycoshield ® Foliar 1.0 lb./100 GPA Tactic 3 12 May 22 May ND – all Reps ND – all Reps Mycoshield ® Foliar 1.0 lb./100 GPA Tactic 4 18 May 22 May 1.4 ,0.9, 0.6, 0.8 2.9, 0.8, 1.6, 0.8 Mycoshield ® Foliar 1.0 lb./100 GPA LI 700 3 12 May 22 May ND – all Reps ND – all Reps Mycoshield ® Foliar 1.0 lb./100 GPA Dyne-Amic ® 3 12 May 22 May ND – all Reps ND – all Reps

Comparison of oxytetracycline residues in mature and new flush foliage collected from the same trees. Residues determined by Bacillus subtilis bioassay. Leaf samples collected by John Curtis, Better Crops, LLC. Leaf analysis conducted by Dr. Xiaoan Sun, FDACS, Div. of Plant Industry.

Table 5: Mycoshield ® - Orange Leaf Residues 2015

Treatment Additive # Appl Last Appl Sampled Foliage Residues (ppm)

Mature New Untreated none 0 NA 19 Aug ND ND

Untreated none 0 NA 22 Aug ND ND Mycoshield ® Foliar 1.5 lb./150 GPA none 1 18 Aug 19 Aug 3.2 7.3 Mycoshield ® Foliar 1.5 lb./150 GPA none 1 18 Aug 22Aug ND ND

Comparison of oxytetracycline residues in mature and new flush foliage collected from the same trees. Residues determined by Bacillus subtilis bioassay. Leaf samples collected by Henry Younce, KAC Agricultural Research, Inc. Leaf analysis conducted by Dr. Xiaoan Sun, Florida Depart ment of Agriculture and Consumer Services, Div. of Plant Industry

Similar results were obtained from a residue analysis of treated orange (Hamlin) foliage from another location. One day after ap plication, the oxyt etracycline residue concentration in new flush foliage was 7.3 ppm, which exceeded th e concentration in mature leaves by more than 2X. At the orange site, residues were not detected in foliage at four days after application

Based on this information then, the followi ng use instructions are proposed for the specific exemption:23  A use concentration of 200 ppm that provid es disease suppression in field trials
and is consistent with th e current maximum use concen tration on the Mycoshield ®

label.

 Full coverage foliar application to the point of ru n-off. Oxytetracycline residues are rapidly degraded and inactivated in the soil . High volume applic ations that result
in the run-off of excess material wo uld be of no pe rformance value.

 Testing the crop safety of tank mixtures to avoid potential phytotoxicity issues.

 Targeting applications to peri ods of new leaf flushes. Th is is supported by disease suppression results, leaf residue analysis and the infection pr operties of HLB.

 Apply at 21 day intervals. Although ther e were distinct benefits with 2- and 3-
week intervals in 2014 and 2015 field trials, there was r oom for improvement. As a bacteriostat, the activity of oxytetracyc line is improved by ex tended intervals of exposure. Residues were not detected in foliage at 10 da ys after applic ation in the grapefruit trial and at four days after app lication in the orange trial. Applications at 3 – 7 day can be made for labeled use fo r control of fire bl ight on apples and

pears.

 Use in combination with an Asian ci trus psyllid management programs recommended by local experts. Imperfect vector control and suppression of HLB would be complementary strategies.

 Studies (Xia, 2012) have shown that high summer temperatures reduce the HLB levels in infected trees and in the psylli d. Thus, this emergency exemption request recommends targeting spring and fall flus hes with oxytetracycline applications when the greatest benefit is expected. The exception would be a grower that intends to use oxytetracyc line in combination with v ector control to delay the infection of newly planted tr ees. In this situation, a ll flushes would need to be targeted with both technologies. Addition al research is needed to investigate the use of oxytetracycline in a preventative program and large treatment areas are needed to optimize the acti vity of the vector control component. The expanded treatment acreage allowed under this em ergency exemption request will enable the investigation of large ar ea HLB prevention programs.

DISCUSSION OF RESIDUES IN FOOD (166.20(a)(6)) (166.20(a)(6))

FireWall TM 50WP and FireLine TM 17WP

AgroSource, Inc. and the IR-4 Project have performed Magnitude of Residue studies for streptomycin sulfate and oxytetracycline in/o n citrus commodities. Field residue studies
have been conducted and this information has been submitted to the Agency or is being24 submitted to the Agency. Diet ary and drinking water exposu re and risk assessment with the current crop uses plus citrus have been performed using DEEM-FCID version 4.02
and citrus residue data from recent citrus field studie s treated with three foliar applications at the proposed Section 18 label rates of both streptomycin and oxytetracycline each applic ation. Based on availabl e information, a temporary streptomycin tolerance of 0.5 ppm and a temp orary oxytetracycline tolerance of 0.1 ppm on citrus are proposed.

For the streptomycin dried pulp fraction, th e proposed tolerance will be 3.5 ppm and for the oil and juice fractions th e proposed tolerance is 0.0 05 ppm (50% of the LOQ).

For oxytetracycline, no residu es (LOQ=0.01 ppm) were found in whole fruit, orange peel, juice or dried pulp in crop resi due trials. Residues of oxytet racycline in orange oil ranged from ND (<0.002 ppm) to <LOQ (0.01 ppm). Therefore, th e NAFTA MRL of 0.01 ppm on the citrus fruit group 10-10 is proposed as the tolerance.

The summary of the residue da ta and the corresponding risk assessments to support the
use of FireWall TM and FireLine TM for on citrus is included in the Appendix D – 3 and D – 4)

Mycoshield ®

A GLP residue study on citrus fruit sponsored by Nufarm Americas Inc. was initiated in March 2015 to support a tolerance petition an d registration application for the use of Mycoshield ® on the Citrus Fruit Crop Group 10-10 commodities. Th e study is expected to be completed by the end of J une 2016. Residue data are cu rrently available for several
of the field trials and incl ude data for raw agricultural commodities and processed fractions. Based on available data, Nufarm is proposing the establishment of time-limited
tolerances for residues of ox ytetracycline in or on orange , Crop Subgroup 10-10A, at 0.4 ppm and grapefruit, Crop Subgroup 10-10C, at 0.4 ppm. A summary of analytical results is provided in the Appendix E - 3.

The proposed time-limited tolerances for orange and grapefruit commodities are
consistent with the toleran ces of 0.35 ppm already estab lished for apples, pears and peaches. The processing study was conducte d at the exaggerated rate of 5 times the proposed application rate of 1.5 pounds Mycoshield ® /acre (7.5 lb. Mycoshield ® /acre). No detectable residues were found in orange juice. Residues in whole oranges and grapefruit were approximately 0.2 and 0.02 ppm, respectively.

To mitigate the small dietary risk posed by the specific exemption us e on Florida orange and grapefruit crop subgroups 10-10A and 10 -10C, a maximum of 8 ap plications per year
and a maximum annual rate of 12 pounds of Mycoshield ® per acre are proposed (compared to the 12 applications and the total rate of 21 pounds of Mycoshield ® per acre used for the conduct of the resi due study on citrus). In ad dition, a retreatment interval of 21 days is proposed instea d of the 2-day retreatment in terval used in the residue25 trials. With these risk mitigati on measures in place, it is very unlikely that any residues
detected in treated citrus commodities will exceed the proposed time -limited tolerances for oxytetracycline in/on orange and grapefru it crop subgroups 10-10A and 10-10C. The
incremental risk associated wi th the Section 18 use is theref ore expected to be below the Agency’s level of concern.

The summary of the residue da ta and the corresponding risk assessments to support the use of Mycoshield on citrus subgroup 10(A) an d 10(C) is included in the Appendix E – 3 and E – 4)

Proposed Time Limited Tolerance

It is anticipated that a single time limit ed tolerance would be set for the use of Oxytetracycline under the Sectio n 18. As a result of the status of the supporting data across both registrants we wo uld propose the following:

 Fruit, citrus, subgroup 10-10A at 0.4 pp m (the highest of the tolerance level
needed for both FireLi ne 17WP and Mycoshield)

 Fruit, citrus, subgroup 10-10B at 0. 1 ppm (needed to cover anticipated residues resulting from the use of FireLine 17WP only)

 Fruit, citrus, subgroup 10-10C at 0.4 pp m (the highest of the tolerance level
needed for both FireLi ne 17WP and Mycoshield)

DISCUSSION OF RISK IN FORMATION (166.20(a)(7))

Description of application sites, incl uding proximity to residential areas, aquatic systems, endangered or thre atened species habitats, soil types,

etc.:

FireWall TM 50WP and FireLine TM 17WP
FireWall TM 50WP and FireLine TM 17WP will only be applie d to commercial citrus groves. These groves are typical of thos e found in Florida. Commercial groves
are intensive and no unreasonable ri sks to human health, endangered or threatened species, beneficial organisms, or the environment are expected from the proposed use of this product. Also included in the Appendix is an executive summary of work done in association with FDA requirements #152, Resistance Risk Assessment for Foliar Applications of
FireWall TM and FireLine TM to citrus crops. With integration of the effective resistance management options, this situ ation does not signif icantly change the existing Qualitative Risk Assessment fo r the emergence of streptomycin or oxytetracycline resistance among clinical pa thogenic bacteria. Since this proposed new use of streptomycin and oxytetracyclin e on citrus crops to improve tree health26 and manage HLB is unlikel y to represent a source for potential emergence of streptomycin or oxytetracycline resistan ce among clinical path ogens, approval of the proposed new use of streptomycin an d oxytetracycline on citrus crops is believed to be in the public interest.

Mycoshield ®
Mycoshield ® will be applied to commercial orange and grapefruit plantings, including all citrus fruit belonging to th e citrus crop subgroups 10-10A and 10-10C (Calamondin; citron; citrus hybrids; grapefruit; Japanese summer grapefruit; Mediterranean mandarin; orange (sour) ; orange (sweet); pummelo; satsuma mandarin; tachibana orange; tangelo; tangerine (mandarin); tangor; trifoliate orange; uniq fruit; cultivars, varieties, and/or hybrids of th ese). Use under the
Section 18 will occur in all areas of the state with commercial citrus groves.

Possible risks posed by use:

FireWall TM 50WP and FireLine TM 17WP

FireWall TM 50WP Fungicide/Bact ericide and FireLine TM 17WP Fungicide/Bactericide are approved products registered by th e U.S. Environmenta l Protection Agency
that have been used in th e field for more than 40 ye ars. Possible risks were evaluated during Section 3 registration and reregistra tion processes for both compounds. FireWall TM is currently registered for use on crops such as beans, celery, peppers, potatoes, tomatoes , apples and pears, and FireLine TM is currently registered for use on crops such as appl es, pears, peaches and nectarines. No
unreasonable adverse effects to man or the environment are anticipated with this proposed use of three applications of streptomycin and three applications of oxytetracycline to Florida citrus. Additional information for FireWall TM and

FireLine TM on these subjects ca n be obtained from Taw Richardson with AgroSource. His phone num ber is (908) 215-3500.

Facts associated with the po tential for increasing the ri sk of human resistance to streptomycin and oxytetracycline have also been addresse d in the TRED for oxytetracycline and the R.E. D. Facts publications for streptomycin, streptomycin sulfate and oxytetracycline. The streptomycin R.E.D. EPA report says that “regarding the problem of drug resistance, EPA has no data indicating that streptomycin residues remaining in the f ood supply have a significant or even a measurable potential for increasing hu man resistance to th at drug.” The Regulatory Conclusion of th at same publication says that “all currently registered pesticide products containing streptomycin or streptomycin sulfate as the active ingredient are not likely to cause unreaso nable adverse effects in people or the
environment.” The TRED fo r streptomycin says that “antibiotic resistance from pesticidal use of streptomycin is unlikely to result direct ly from dietary residues of streptomycin because dietary residues are very low. The drug dose is 3,000 times greater than the estimated pesticidal di etary exposure. Th e small dose from27 (streptomycin) pesticidal ex posure would not be expected to select for resistant bacteria because very few bacteria woul d be killed by this small dose.”

The streptomycin FDA #152 study summary paper notes that “streptomycin has been safely and effectivel y used in plant agricultur e since 1955, yet a direct connection to the emergence of streptomyc in resistance among clinical pathogens as a consequence of this use pattern re mains undocumented. EPA has previously determined that the dietary ex posure to streptomycin is be low its level of concern. The use of streptomycin to manage HLB in commercially grown citrus crops does
not increase the chronic a ggregate exposure to a leve l of concern, since the combined aggregate residential and chroni c dietary exposure to all agricultural applications of streptomycin, including the proposed us of streptomycin on citrus crops is 2,491 times less than the No Obse rved Adverse Effects Level (NOAEL) for the total U.S. population and 719 times le ss than the NOAEL for the most affected population subgroup, non-nursing infants. Dietary intake of streptomycin does not
constitute a source of select ion pressure for streptomycin resistance among enteric gut flora, since the dietary exposure fr om streptomycin applications to plant agriculture is so low and oral absorption for streptomycin is extremely low (<1%). Recent studies have revealed streptomyc in-resistant isolates of many plant pathogenic bacteria exist as stable popu lations in the enviro nment, even where streptomycin has never been applied, givi ng indication that factors other than streptomycin applications in the field influence the emergence of streptomycin resistance among plant pa thogenic bacteria.”

Similarly, the R.E.D. publication for oxytetra cycline says that the “use of the active ingredients hydroxytetracyc line monohydrochloride and ox ytetracycline calcium in accordance with approved labe ling will not result in unreasonable adverse effects
to human health or the envi ronment.” Facts pertaining to risks have also been addressed in association with the potent ial for increasing the risk of human resistance to oxytetracycline in EPA’s TRED for oxytetracycline, as well as the FDA #152 assessment. The EPA oxytetracy cline TRED concluded that “because anticipated dietary residues are extremel y low, it is unlikely that antibiotic resistance from pesticidal use of oxytetracy cline would result from food exposure,” and “the drug dose is 50, 000 times greater than the es timated pesticidal dietary exposure (25 mg/kg/day dose divided by maximum aggregate dietary exposure of 0.000473 mg/kg/day). The sma ll dose from pesticidal exposure would not be expected to select for resistant bacteria because very few bacteria would be killed by this small dose.” In th e latest oxytetracycline dietar y risk assessment, the drug dose is nearly 82,000 times greater than th e estimated pesticidal dietary exposure [25 mg/kg/day dose divided by maximum aggregate dietary exposure of 0.000305 mg/kg/day for non-nursing infants (the highest population sub-group)]. Therefore, anticipated dietar y residues of oxytetracyclin e are extremely low, and it is also unlikely that antibiotic resistance from the pesticidal us e of oxytetracycline would result from food exposure.28 The AgroSource oxytetracy cline FDA #152 study summ ary paper notes that “oxytetracycline has been safe ly and effectively used in plant agriculture for more than 40 years yet a connection to the em ergence of oxytetracycline resistance among clinical pathogens re mains undocumented. EPA ha s previously determined that dietary exposure to oxyt etracycline is below its leve l of concern. The use of oxytetracycline to combat HL B in citrus crops does not significantly increase the chronic aggregate exposure to oxytetracycline. Dietary in take of oxytetracycline is not expected to constitute a source of selection pressure for oxytetracycline resistance among enteric gut flora since the co mbined aggregate residential and chronic dietary exposure to all agricultural applications of oxytet racycline, including the proposed us of oxytetra cycline on citrus crops, by non-nursing infants is 164
times less than the NOAEL , and approximately 82,000 times less than the commonly prescribed therap eutic dose for this most affected population subgroup.”

As a condition of the approv al of a Section 18 exempt ion for the use of FireWall TM 50WP for the management of citrus canker ( Xanthomonas citri pv. citri ) on commercially-grown grapefruit in Florida, field studies were co nducted during the 2014 season designed to detect potential development of streptomycin resistance
in the culturable microbial communities from both phyllosphere and rhizosphere
zones of FireWall TM 50WP treated (tested) and un treated (control) trees. Two commercial grapefruit grower cooperators provided a total of five unique test sites,
all located within the Indian River Citrus growing region of southeastern Florida. No test site had previously received any treatments with streptomycin or streptomycin-based products. FireWall TM 50WP was applied to the test sites following the Section 18 label directions. Samples for cult urable bacteria (as found
in soils from beneath each tree and leaves taken from ea ch tree) were collected at four dates beginning in August 2014 (T0) and ending in December 2014 (T3). Samples from all FireWall TM 50WP treated and corresponding untreated plots were analyzed for evidence of streptomycin-res istant bacteria. When the data were analyzed across all five test sites, result s indicated no consistent and significant change (p=0.05) in phyllosphere or rh izosphere microbial po pulations. More importantly, results revealed no evid ence for development of streptomycin resistance among bacterial populations resident in FireWall TM 50WP treated grapefruit trees or soils in response to the use of FireWall TM 50WP on Florida grapefruit for management of citrus canker.

Mycoshield ®

Mycoshield ® is currently registered for us e on apples, pears, peaches and nectarines. Occupational exposure and risk are no t expected to exceed the Agency’s level of concern since airblast application at the same maximum rate of 1.5 pounds of formulated product per acre per application is already registered for peaches, nectarines and apples. EPA st ated in the 2008 Health Effects Division (HED) Scoping Document for Registration Review of oxytet racycline that an29 occupational assessment was not needed because of the low level of exposure anticipated from application of oxytet racycline products and the personal protective equipment required by the S ection 3 label that includes protective clothing, chemical-resistant gloves, pr otective eyewear and a respirator. The occupational exposure and risk associat ed with the proposed Section 18 use on Florida citrus is therefore expected to be well below the Agency’s level of concern.

The proposed time-limited to lerances of 0.4 ppm for resi dues of oxytetracycline in or on orange, Crop Subgroup 10-10A, an d grapefruit, Crop Subgroup 10-10C, are
based on data available to date from the ongoing magnitude of residue study (included in the Appendix E). Twelve fo liar airblast applications of Mycoshield ®

were made at the maximum use rate of 1. 5 pounds of formulat ed product per acre per application with a 2-day retreatment in terval plus two trunk applications of Mycoshield ® at 1.5 pounds of formulated product per acre per application. This resulted in a total application rate of 21 pounds of formulated product/acre (3.57 lb. oxytetracycline/acre) whereas the prop osed Section 18 label limits application to 12 pounds of formulated product/acre (2.04 lb. oxyt etracycline/acre) total per

year.

In the 2008 EPA Health Effects Division ’s Scoping Document for Registration Review of oxytetracycline, EPA concluded that expected dietar y (food and water) risk for the U.S. po pulation and all subpopulations was conservative and below the level of concern. Acute dietary exposu re was not estimated because no acute toxicity was identified in any of the relevant stud ies in the oxytetracycline database. As a result, EPA determined that acute dietary risks are not of concern.

In order to investigate potential exposure and risk associated with the proposed
Section 18 use on Florida ci trus, Nufarm sponsored a chronic aggregate dietary assessment for currently registered uses of oxytetracycline an d the proposed use
on citrus in Florida. The available data from Nufarm’s residue study on citrus were used to assess dietary exposure. The resu lting chronic risk es timates are not of concern for any population assessed. Based on this assessment, there are no dietary exposure issues that would precl ude the specific exempt ion use on citrus
trees in Florida. Since there is no reside ntial use of oxytetracy cline, an assessment that aggregates more than fo od plus water is not needed.

A drinking water exposure assessment was also conducted for currently registered uses of Mycoshield ® and the proposed Section 18 us e on Florida citrus trees. The resulting drinking water concentrations were used in the dietary risk assessment. Concentrations were calculated to be very low or practically non-existent (report included in the aggregate di etary risk assessment). Th e impact of the Section 18 use on the ecological risk is not expected to exceed the Ag ency’s level of concern. Oxytetracycline residues degrade rapidly in citrus foliage. As discussed in the section “Effectiveness of Proposed Use unde r Section 18”, leaf residue analysis has shown that oxytetracycline residues were no longer detectable in foliage 10 days30 after application to a grapefru it location and 4 days afte r application to an orange

site.

Nufarm has responded to Data Call-In notices issued for the TRED and Registration Review of Oxytetracycline. Several studies including environmental fate and ecotoxicology studies were conducted to support the continued registration of Mycoshield ® . Most of these studies have already been submitted to
the EPA or will be submi tted in the near future.

Regarding the potential for resistance develo pment, it is unlikely that antibiotic resistance from pesticidal use of oxytetracy cline would result from food exposure. Anticipated dietary residues for existing ag ricultural uses of ox ytetracycline and the proposed Section 18 for Florida citrus ar e extremely low (conservatively estimated at 0.000076 mg/kg/day for the general U.S. population). The maximum aggregate dietary exposure calculated is very sm all when compared to pharmaceutical or veterinary doses. The sma ll dose from pesticidal expo sure would not be expected
to select for resistant bacteria because ve ry few bacteria would be killed by this small dose. An assessment of the potentia l for antibiotic resistance to develop as
a result of the use of Mycoshield ® on citrus was conducte d following FDA Guidance #152 and is included in Appendix E-4. Additional inform ation for Mycoshield ® on these subjects can be obtained from Bill Bewlay with Nufarm.31 Proposals to mitigate risks:

Existing use restrictions already li sted on both the streptomycin and oxytetracycline labels will further reduce risk . These label restrictions include: do not apply directly to water, or to areas where surface water is present, or to intertidal areas below the mean high wa termark; do not contaminate water when disposing of equipment wash water; do no t apply by aircraft; do not apply these products through any type of irrigation system; and, only three applications of streptomycin and three applications of oxytetracycline are allowed per season. Current labeling directives are sufficient to mitigate any potential risks. Full reports of tests and investigations made wi th respect to the safety of streptomycin and oxytetracycline, includ ing all information pertai ning to the methods and controls used in conducting these tests and investigat ions have been submitted and reviewed by the Agency.

The enforcement analytical methods for both products are available to monitor residues of streptomycin an d oxytetracycline in citrus.

FQPA INFORMATION (OCTOBER 24, 1996 EPA LETTER)

EPA requested that additional informatio n be submitted with Emergency Exemption requests to address new risk considerations associated with requirements of the Food Quality Protection Act. This information has been provided to the Agency. Since these products are approved for other Section 3 regist rations an initial FQPA review has already
occurred.

COORDINATION WITH OTHER AFFECTED FEDERAL, STATE, AND LOCAL AGENCIES (166.20(a)(8))

As EPA’s state lead agency, the Florida Depart ment of Agriculture and Consumer Services should provide this information.

NOTIFICATION OF REGISTRANT (166.20(a)(9))

AgroSource, Inc. and Nufarm Am ericas Inc. have been notifi ed of this request. The companies are supportive of this emergency exemption peti tion (see the Appendix for registrant support letters).32 DESCRIPTION OF ENFORCEMENT PROGRAM (166.20(a)(10))

As EPA’s state lead agency, the Florida Depart ment of Agriculture and Consumer Services should provide this information.

REPEAT USES (166.20(a)(11))

This is the first request for the use of each of the requested products, streptomycin and oxytetracycline on citrus by Florida for management of HL B and improvement of overall
citrus tree health. The use of antibiotics under this Emer gency Exemption Request will suppress HLB in new growth bu t will not cure the infection in the branches, trunk and
roots. The reservoir of bacter ia in the lower portions of th e tree is a source for constant reinfection. Even new planting s are subjected to co ntinuous pressure from ‘hot’ psyllids. A Section 18 Emergency Use Exemption would be needed until the S ection 3 registrations
are obtained.

PROGRESS TOWARD REGISTRATION (166.25(b)(2)(ii))

FireWall TM 50WP and FireLine TM 17WP

AgroSource, in conjunction with the IR-4 Project, continues to make progress toward new registrations for the use of st reptomycin and oxytetracycline on the citrus crop group and a variety of other crops. The company is preparing or has prepar ed and submitted the necessary documentation for a S ection 3 registration for citrus . The application to amend the Section 3 label for streptomycin has been submitted to EPA (Decision Number: 486863) and a Pesticide Registration Improveme nt Extension Act (PRIA) due date of 05/04/2015 had been assigned. EPA subsequently decided to require that this request go through a “public participatio n process”. As part of prep aration for this process, EPA issued a deficiency letter to AgroSource (to provide more benefits information) and both parties “mutually agreed” on a new PRIA da te of June 2016. Su bsequently, the new submission goal for oxytetracyc line on citrus is now October 1 st , 2015 and for streptomycin the new citrus su bmission goal is November 1 st , 2015.

Mycoshield ®

A GLP residue study on citrus fruit sponsored by Nufarm Americas Inc. was initiated in March 2015 to support the re gistration of Mycoshield ® on the Citrus Fr uit Crop Group 10- 10. The study is expected to be completed by the end of Ju ne 2016. It will then be submitted to the EPA in support of a tole rance petition and Section 3 registration application. Nufarm anticipates submitti ng the application by August 1st, 2016. Assuming a timeline of 15 months for the EPA review, the registration could possibly be granted by the end of November 2017.33 Nufarm is the basic registrant for Oxytetracyc line Calcium and is responding to Data CallIn notices issued for the TRED and the Registration Revi ew of Oxytetracycline. Several studies were required includin g environmental fate and ecot oxicology studies that also support the Registration Review of Oxyt etracycline Hydrochlor ide (Appendix E-5).

NAME OF PEST (166.20(b)(1))

Scientific Name:

Candidatus Liberibacter asiaticus ( C Las)

Common Name:

Disease: Huanglongbing (HLB) or Citrus Gr eening or Yellow Dragon Disease

Vector: Asian Citrus Psyllid (ACP) ( Diaphorina citri Kuwayama)

DISCUSSION OF THE EMERGENCY CONDITION (166.20(b)(2))

Citrus huanglongbing has been known in China for more than 100 years. In 1929, a disease with similar symptoms appeared in South Africa and was named ‘yellow branch’ in Western Transvaal and ‘greening’ in East ern Transvaal. The ag ent associated with the disease was transmitted by graft-inoculatio n from citrus to citrus for the first time by Lin in China in 1956. This work re mained unknown outside China; McLean and
Oberholzer demonstrated independently that South African greening was grafttransmissible. Because ‘huanglongbing’ wa s the name used in the paper describing graft-transmission of the agen t for the first time, it has priority over other names and has been unanimously adopted as the official name of the disease by the International Organization of Citrus Virologists (IOCV) at the 12th Congress of IOCV, Fuzhou, China,

1995.

In the 1960s, the agent was shown to be tran smitted by two insects: the African citrus psyllid Trioza erytreae in Africa and the Asian citrus psyllid Diaphorina citri in Asia.

Symptoms of HLB were report ed in Sao Paulo state in Br azil in 2004. Then, in 2005, HLB, was found to be present in Florida. This disease is caused by the pathogen
Candidatus Liberibacter asiaticus and is spre ad by the Asian citrus psyllid ( Diaphorina

citri Kuwayama), which is an invasive pest to Florida, first discovered in 1998. HLB is
considered to be the most serious disease of citrus worldwide and has greatly limited commercial production of citrus in countries where it is pres ent. Since its discovery in Florida, this disease has rapidly spread throughout citrus production area to all34 commercial production areas in the state. The graphic below ill ustrates the rapidity
with which HLB inva ded Florida commercial citrus counties:

(Source: CRDF Presentation to EPA, February 5, 2014)

HLB is a prime example of how an unintentional, but illegal, plant introduction into a country can cause multi-bill ion dollar crop losses, unemp loyment and industry-wide
financial strain. The HLB bacterium lives in the vascular system component (phloem) that conducts synthesized food materials from the tree to the root s. Like the human blood vessels, a blockage of these vascular system conducting ti ssues by any foreign substance produces deleteriou s effect. The presence of C Las in the phloem prevents the tree from effectively transporting water, nutri ents and minerals betw een the leaves, fruit and the roots in the gr ound, thereby driving th e tree into decline. Since this disease’s appearance, citrus production has been compromised with th e loss of millions of trees, and HLB has subsequently been detected in every county wi th commercial ci trus and in residential dooryard citrus as well. Trees infected with HLB will continuously decline and eventually die, even when incorporating all management options available to the industry at this time. The HLB-causing bacterium found in Florida is the Asia n species that occurs
in warm low altitude areas. HLB survives and multiplies within the psyllid vector throughout the psyllid’s lifetim e. The psyllid was first fo und in Florida in June 1998.

The severity of HLB and declin ing tree health far exceeds th at of any previously known citrus disease, and all citrus species and their hybr ids are confirmed to be affected by HLB. Infected trees first produce leaf sympto ms; typically leaf yell owing on one or more branches, then leaves develop a blotchy (irregular spotted) appearance with grades of color. Infected trees typi cally also show symptoms that resemble micronutrient deficiency, especially, zinc and manganese. Fruit set becomes thin, fruit appear lopsided, the lopsided fruit may contain aborted seed s, and juice qualit y is unacceptable.

Impacts from HLB are numerous. On infected trees fruit are few in number, small, lopsided with a curved centra l core, and they fail to colo r properly, remaining green at the stylar end (hence the name “greening”). Excessive frui t drop occurs prematurely on35 afflicted trees, and this has been reported in the past three harves t seasons in Florida to exceed 10 percent per season across all varieties. Even if fruit rema in on the tree until harvest, the fruit are undersized and contai n bitter juice, rendering it of reduced
economic value. From a fruit size standpoint, HLB-infected trees have a significantly greater portion of fruit in smaller size cate gories compared to he althy trees (more than 95% of symptomatic fruit are le ss than 2.25 inches in diam eter). Total juice volume produced is less from HLB-posi tive trees because of the sm aller fruit size as well.
Extensive research has been do ne to characterize the off- flavors associated with HLBinfected trees, highlighting both the gene ral brix/acid ratio impacts as well as the components that contribute to flavor. This work is presente d in detail by Baldwin, et al. 2010, Ikpechukwu et. al, 2011, Plotto et. al., 2013 and Massenti et. al. 2015.

HLB disease and the lack of any tree health improvement an tibiotic has already pushed
untold numbers of farmers ou t of the industry. Between 2004 and 2014, the amount of Florida land planted with citr us shrunk by nearly one-thir d, from 748,555 acres down to 515,147 acres (USDA, FASS). Duri ng that same timeframe, ov erall citrus production in the state dropped from 292 m illion boxes of fruit down to 124 million boxes (a 58% reduction). Average orange yields sunk from 428 boxes per acre in 2004 down to 250 boxes an acre in 2014 (a 42% reduction), de spite the higher-densi ty new plantings of orange trees, almost solely re sulting from HLB infection.

Also contributing to the situation (and the continued higher grove maintenance costs) are Asian citrus psyllid management requiremen ts. Since the psyllid’s discovery, annual production costs have more th an doubled. The majority of these increased costs are derived from psyllid management requiremen ts and the necessary modified cultural practices. Psyllid management is an absolute necessity with respect to controlling HLB spread; the threshold for psyllid treatment has become “less than zero ” in the industry. A high proportion of psylli ds are now infected with th e bacteria and capable of transmitting the disease. Fl orida citrus growers are curre ntly spending more than $240 million a year on insecticides directed so lely to manage psylli ds, which is about 30 percent more than they were spending in 2004, even th ough they're farming about 30 percent less land and yieldi ng half as much fruit.

Citrus production and resear ch experts believe that looki ng forward, the pursuit of interventions to reduce Asian citrus psy llid populations, redu cing HLB bacterial populations within infected trees, and promotio n of optimal tree health in the presence of HLB are the keys to the citrus industry’s sust ainability. The industry to this point has pursued a three-pronged approach to combatin g HLB, focusing on interventions on the three components of the dise ase pathosystem. The first component involves managing the psyllid. The second is understanding the bacterium it self, with the goal of hopefully neutralizing impact on psyllids or trees. Access to antibiotic materials such as streptomycin and oxytetracycline is vital to induce the improvement of tree health and subsequently keep trees viab le until these other HLB mana gement approaches can be developed. The third component is to breed new citrus trees that will hopefully tolerate
or resist infection.36 HLB is truly a limiting factor for citrus prod uction. In the attempt to improve tree health to the degree possible, cultural practices such as foliar micr onutrient sprays are employed once HLB infects a tree, but these effects are sh ort-lived and certainly will not sustain the industry. HLB is already direct ly responsible for the loss of thousands of acres of Florida citrus trees. An emergency exemption involv ing multiple antibacterial strategies that enables improved fruit pr oduction must be gained in orde r to counter the impact of this bacterium/vector complex that is threatenin g the short- and long-term viability of the state’s $7 billion citrus industry . Without such antibiotic a ccess and without anything else changing, within five to eight years of becoming infected , diseased trees will no longer be economically productive.

Limitations on replanting to replace declinin g tree inventories have made it critical to extend the productive life of the more than sixty million ma ture citrus trees in commercial groves. Continued production from this in ventory of mature (infected) trees while new trees come on line is the proc ess by which the Florida citrus industry can avoid failure and loss of critical nursery, production, harves ting, processing, packing and marketing
infrastructure.

The graphic above emphasizes the point that despite ACP management programs, new plantings are still becoming infected and th ese would be primary targets for bactericide

treatment.

Biology of C Las and Disease Onset/Progression

The complicated biology of HLB and the intera ctions between vector , pathogen and host citrus plant make development of solution s challenging. Following inoculation of C Las into uninfected citrus trees, a period of latency follows during which time there is no37 evidence of infection. Early symptom development is manifested th rough mottled foliage, followed progressively by smaller an d narrower leaves, reduced mature fruit size and thinning of canopies. Ch ronic symptoms includ e limb dieback, frui t yield and quality reduction, and pre-harvest shed ding of mature fruit. The time period of this disease progression varies with tree age and inoculum pressure, but generally in mature trees chronic decline appears with in three to four years of initial infection.

New information on Root Impacts

Research reported over the pa st three years (Graham et. al ., 2012, Johnson et. al., 2014, and Graham and Morgan 2015) has revealed that C Las infection of citrus involves early
movement of bacteria to root systems, where direct impacts on root health result. Root systems of infected trees have relatively fe wer feeder root densities, diminishing water and nutrient uptake efficiencies and exposing diseased trees to additional stress. Further
evidence from field research ha s demonstrated that HLB-infect ed trees are susceptible to lower populations of Phytophthora propagules than healthy trees, indicating that HLB
infection allows soil diseases to overco me or break rootstock tolerance.

Significant economic loss has b een experienced through lowe r fruit quality and smaller fruit size as described below, and proposed bacterial therapies have the potential to improve this aspect of the disease as root sy stems are restored. Strategies that address
reduction in C Las titers in infected plants are few, but focus on redu ction of bacterial levels early in disease development.

While research continues to further eluc idate the impacts of early migration of C Las into root systems, it has become necessary for growers to apply additional treatments for Phytophthora, root weevils and ot her soil stressors. It is exp ected that this root health compromise will also impact the ability of citr us trees to respond to weather disruptions
like freeze events or sust ained heavy rainfall.

Non-Routine Emergency Situation:

The rapid decline of HLB-infect ed mature citrus trees as ev idenced by reduction in fruit size and quality and with the dramatic increa se of fruit drop as fruit reaches harvest maturity.

Dr. Ariel Singerman of the University of Fl orida, IFAS, Citrus Re search and Education Center has updated grower esti mates of the spread of HLB in Florida and its impacts on production. This study is included in the Appendix and is posted at http://www.crec.ifas.ufl.edu/ext ension/economics/. Here ar e highlights regarding HLB
incidence in Florida:

 57 percent of growers surv eyed report that 100 per cent of their groves were infected, while 24 percent and 13 per cent reported 80-99 percent and 60-80 percent infection, respectively.38  On a tree-by-tree basis, 15 percent repo rted 100 percent of their trees were infected, while 49 percent and 21 per cent reported 80-99 percent and 60-80 percent tree infection rates, respectively.

 80 percent of respondents reports yield lo sses in the range of 20-60 percent, with 13 percent of respondents reporting more than 60 percent yield loss.

These estimates reinforce official crop pr oduction figures from USDA/FASS reported elsewhere in this petiti on and highlight the level of impa ct on individual growers as the
disease decline continues.

DISCUSSION OF ECONOMIC LOSS (166.20(b)(4))

The damage resulting from HLB infection is co nsiderable. Diseased trees decline, yields are reduced, and fruit quality is affected. As the disease severity increases, yield is reduced through a combination of smaller crop set, preharvest fruit drop from affected
branches and smaller fruit si ze. The yield reduction ca n reach 30 to 100 percent, depending on proportion of affected canopy. This level of diseas e progression makes the grove economically nonviable 7 to 10 years after planting. As disease severity increases, the percentage of affected fruit increases, re aching more than 40 percent. The affected fruit are smaller, lighter, very acidic, with reduced Brix, ratio, percentage of juice and soluble solids per box, an d juice quality is negatively impact ed. Millions of citrus trees in Florida have been affected by HLB and subsequently destroye d. The last projected value
that has been established as a direct cost of HLB to Florida’ s citrus indust ry is around $300 million annually.

The loss of production is felt by more people than just the famers th at grow citrus. As production declines, packing ho uses do not run, box makers do not sell their products, shipping companies do not operate, etc.

Dr. Ariel Singerman, Assistant Professor of Agricultural Econ omics at the University of Florida, IFAS, Citrus Research and Education Center, has recently eval uated the impact of HLB on citrus production costs across the thr ee general production re gions of the state. His work is posted on http://www.crec.ifas.ufl.edu /extension/economics/. Below is a summary of Dr. Singer man’ s findings from citrus production operations in the three regions:

Central Florida (Ridge) Cost of Pr oduction for Processed Oranges:

The Table below shows total costs growers in curred for 2014-15, which includes cultural costs, tree replacement plus other costs such as ma nagement, regulatory and opportunity costs. The tota l cost of production for pr ocessed oranges for 2014-15 is reported to be $2,282.19 per acre. Contributi ons to cultural oper ations include foliar39 sprays at $705.30 per acre; Ci trus Health Manage ment Area (CHMA) sprays $56.65 per acre; fertilizer expense at $469.80, and weed control at $246.31. With thinner tree canopies and open spots wher e HLB has caused tree death, even weed management
costs have escalated. This can be compared to produc tion costs averaging $700-800 per acre prior to HLB.

Table 6: Total Costs of Production pe r Acre for Processed Oranges in Central Florida (Ridge), 2014/15.

Southwest Florida Cost of Prod uction for Processed Oranges:

Similarly, costs for production of oranges in southwest Florid a continue to climb, in the Table below excerpted from this section of th e Singerman report. In this case, foliar sprays average $666 per acre plus $20.55 fo r CHMA sprays. Fertilizer costs were $486.90 per acre, and weed control averaged $248.19. The total cu ltural operations costs of $1,998.10 per acre are more than double those expe rienced prior to HLB impact.

Table 7: Total Costs of Production per Acre for Processed Oranges in Southwest Florida, 2014/15

Indian River Cost of Production for Fresh Grapefruit:

In the case of the Florida’s prem ier production area for fresh grapefruit, the Indian River, the production costs mirror the increases ob served in the other regions for processed40 oranges, but are magnified du e to the need for fresh frui t quality and its impacts on production costs. The Table below from the In dian River portion of the report indicates a total of $2,478.61 cultural co sts for 2014-15 and an overall pe r acre average production cost of $3,073.38 per acre. Re levant operational costs ar e $1,300.40 per acre for foliar sprays and $14.75 for coordina ted sprays (CHMA) ; fertilizer costs average $452.55 per acre and weed control averaged $190.60 per acre. This compar es to fresh fruit production costs prior to HLB that averaged $1,000- 1,200 per acre per year.

Table 8: Total Costs of Production per Acre for Fresh Market Grapefruit Grown in Indian River, 2014/15.

Integrating the increased produc tion costs for Florida citrus with statewide declines in per-acre yields illustrates th e emergency status and the bu siness failure that is being
witnessed in Florida. Small- and medium-s ized operations are eco nomically abandoning
blocks of citrus which have fallen below brea k-even levels for several consecutive years, reducing any further losses associated with continued investment in the face of continuing decline in production . An option considered by so me is reduction in inputs to offset smaller crop size and quality. Experi ence over recent years indicates that this pullback in intensity of management of tree heal th accelerates the dise ase decline and only
hastens economic abandonment. At the same time, thes e unmanaged groves become a
source for inoculum for th e pathogen and reservoi r for the vector ACP.

Large citrus operations in Florida are facing similar decisions on th e declining return or loss due to HLB, and are risk assessing individual blocks ea ch year to determine where investments are warranted. They, too, are removing groves that have fallen below economic return thresholds from active management.

This scenario also is not favorably affectin g growers’ interest in replanting, as the uncertainties of being able to sustain produc tion on new trees is influenced heavily by their experience with standing gr oves. Data on declines in nursery tree production in the past year attests to this uncertainty, despite availability of indust ry and other incentive programs to replant. The health of Florida’s citrus industry is usually mirrored in nursery production. As industry produc tion falls or fruit prices weak en, citrus nursery tree orders suffer. A total of 54 citrus nurseries pr opagated 4,438,128 trees in 2014-15, which is a decrease (5.8%) from last year. Nursery ac tivity was strong for several new nurseries41 that began producing trees th is year; 6 new nurseries acco unted for over 5 percent of the total nursery propagations. Existing nur series mostly saw a decline in budding and
tree orders. A total of 33 nurseries had redu ced production from th e previous year and only 15 saw an increase. Overall, tree pr oduction based on reports decreased by 274,311 trees. Taking into acco unt that six new nurseries co ntributed to th e production figures, it signified a downwa rd trend for most nurseries. (FDACS Budwood Certification Program, Annual Report 2014-15).

The Economic Impact of HLB on the Florida Citrus Industry:

As described in a recent publicat ion, this disease and the resu lting loss of production cost the industry over $7 billion in lost revenue by 2012 (Hodges A.W., Spreen T. H., 2012). This loss of production transl ates to more than 8,000 lost jobs over the same five-year period. As trees succumb to the effects of the disease, th e industry is faced with the challenge of replanting groves to replace th e lost production. Although these figures have not been formally updated, the losses ha ve risen considerably since this analysis was published.

Economic Effects of HLB in Florida:

Florida’s iconic citrus industry is an essential part of the economy of Florida, especially in
the 28 central and southern counties of Flor ida where citrus is grown and processed. The most recent study before HLB became endemic put the overall economic impact at $8.91 billion and prov ision of 75,827 jobs.

However, in 2012 economists calculated that over $4.5 billion in ec onomic impact had
been lost because of the effect s of HLB on the Florida orange juice industry for the period 2006 to 2010. The report details the category of losses, i.e., dir ect economic impacts, indirect economic impacts and in duced impacts. On average, Florida’s economy suffered with the loss of $908.2 million dollars each year, and 8,257 permanent jobs.

These losses are mainly becaus e of the reduced production of Florida oranges versus a
scenario without the effects of HLB in the ci trus growing environment. Losing orange production is exacerbated by further losses of the value-added segment of the industry, that is fruit processing, jui ce manufacturing, and juice pack aging and distribution. Since most of the orange juice sold in the United States is produ ced solely in Florida, this
becomes a loss of economic bene fits for Florida residents.

As the disease progresses, more losses are expected each year . An estimate of the most current losses are explained by looking at Flor ida citrus production statistics over the period prior to first det ection of HLB in Florida ( 1996-1997 through 2005-2006) and the decline in production experi enced in the recent three ye ars as a result of both
accumulation of disease across the state as well as the cumu lative decline due to multiyear chronic HLB infe ction (Table 9).42 Table 9: Florida Citrus Production Stat istics during the Period 1996-1997 through

2013-2014.

Crop Production by Fruit Type 1996-1997 through 2014-2015

Crop Year Oranges Grapefruit Other

Citrus Total (1,000 Boxes)
1996-1997 226,200 55,800 13,315 295,315
1997-1998 244,000 49,550 10,900 304,450
1998-1999 186,000 47,050 10,115 243,165
1999-2000 233,000 53,400 12,030 298,430
2000-2001 223,300 46,000 9,505 278,805
2001-2002 230,000 46,700 10,565 287,265
2002-2003 203,000 38,700 9,305 251,005
2003-2004 242,000 40,900 8,900 291,800
2004-2005 149,800 12,800 6,650 169,250
2005-2006 147,700 19,300 7,600 174,600
2006-2007 129,000 27,200 5,850 162,050
2007-2008 170,200 26,600 7,000 203,800
2008-2009 162,500 21,700 5,000 189,200
2009-2010 133,700 20,300 5,350 159,350
2010-2011 140,500 19,750 5,800 166,050
2011-2012 146,600 18,850 5,440 170,890

2012-2013 133,600 18,350 4,280 156,230
2013-2014
2014-2015 115,000 96,700 16,500 12,950 4,400 2,980 135,900 112,630

Source: USDA, National Agricultural Statistics Service, FASS, Florida Citrus

Statistics. 2011-2012, published February 12, 2013. Data for crop years 2012-

2013 and estimates for 2013-2014 provided by USDA, NASS, FASS, Citrus

Forecast, January 10, 2014. 2014-15 Ju ly 10, 201 Final Forecast for Season.43 Note: The above graph depicts the data in the table for total production, all varieties, and is included as an altern ative data presentation, or to be used elsewhere in the petition.

Losses have now reached levels that annual citr us production is less than half of what it was as recently as 2003-2004. The decrease in fruit in successive ha rvests over the past

three seasons is shown here:

2010-2011 to 2011-2012 9%

2012-2013 to 2013-2014 11%

2013-2014 to 2014-2015 17% Net loss (3 years) = 34%

With the rapid spread of HLB disease, and th e increasing infection rates within standing groves, the situation that we are experien cing now in Florida is a combination of:

 Widespread infection of citrus trees thro ughout the growing region of Florida.

 Heavy inoculum in infected trees available for acquisit ion by the vector, ACP. Recent samples indicate up to 100 percent of field-collected AC P are positive for

C

Las, the pathogen.

 Limited removal of infected trees means that local spread can be rapid if psyllids are not managed effectively. With high rates of infection within a block, tree removal is not practical. 0 50,000 100,000 150,000 200,000 250,000 300,000 350,000 

### Production (x1000 boxes)44  The accumulation of years of progressive infection by C Las means that a higher percentage of trees are be ginning to show chronic infection, including more widespread symptoms within trees, thinne r canopies and impaired root systems.

 These factors all contribute to the reduced fruit producti on (yield), even though the official acreage of citrus plantings has not declined si gnificantly in the last few years. And,

 Fruit quality is declining, in size, flavor and maturity.

Thus, the productive population of mature tr ees is declining in health and productivity, and will likely continue to do so without eff ective therapeutics, wh ich currently are not available. In addition, new citrus trees that are either inter-planted in existing groves of mature trees or planted solid in new blocks are at high risk to infect ion via the ACP vector bringing inoculum from C Las reservoirs. It is these new tr ees that will provide the ability for economic production of ci trus to continue, and the confidence to replant is, at present, limited by early and fa tal infection of young trees by C Las through psyllid

transmission. Trees in the firs t 4-5 years of growth are partic ularly vulnerable since they grow new flush off-cycle when other trees are not producing new leaves. This makes

them more attractive to AC P colonization and vulnerable to disease transmission.

The importance of management of HLB in Florida citrus is reduced to two major considerations. The first is to delay further health decline in existing mature trees that will further erode production. Second, and more vital, is the ability to manage ACP populations in young plants, ther eby providing confidence to gr owers to replant. Both of these considerations could be po sitively impacted by availabi lity of effective bactericides.

Consideration of Expected Economic Be nefits of Improved HLB Management, Particularly Through Availability of Bactericides

This overview adds insights by attempting to quantify potential economic benefits to

Florida if research efforts chan ge the trajectory of any one of several factors that affect the economic impact of citrus pr oduction (specifically oranges) in the state. The initial overview focuses on the various aspects of prod uction, such as acreag e, yields, fruit loss to drop and quality reduction and other meas ures of decline due to HLB that would be expected to show improvement with implementa tion of an effective bactericidal program, as well as the trends in replanting, which likewise would be exp ected to improve as bactericidal therapy is made available.45 To understand the economics of expected response to exposu re of HLB-infected trees to

a time course of one or more bactericidal treatments, it is important to outline the disease progression associated with this disease and to de termine which aspects of the disease impact would be improved through treatm ent. As stated ear lier in this petition, infection of citrus by C Las is initially invisible, followed in a multi-year time course by a series of symptoms and injury which begin as foliar mottling and chlorosis and progressing to reduction in canopy densit y, and leaf size, an d overall appearance of

decline in one or more branches of the infected tree. General declin e reflects root injury and limited movement of plan t products through the impair ed vascular system. With time, the appearance of small fr uit, further thinning of cano pies, and leaf and premature fruit drop signal more advanced imbalance in the tree. Leaf sy mptoms also include general chlorosis (yellowing) and their noticeable appearan ce as thinned canopies, with bare patches within the canopy of chronically inf ected trees. These advanced symptoms,

and the continued decline to death of chronically infected trees, may not appear for several years following infection, or even fo llowing first visual symptoms. The general decline is symptomatic of the breakdown of several plant systems, including roots (lower feeder root density), reduced vascular move ment (phloem plugging ) of nutrients from sources to areas of need (leave s to roots, roots to developing fruit, etc.), and impaired photosynthesis due to canopy loss.

Thus, in evaluating the expect ed response to treatment of C Las in infected trees, the forgoing description also defines the measur es necessary to determ ine stabilization or recovery from disease symptoms. Expected changes in the following parameters can be predicted from previous resear ch on epidemiology of HLB in citrus and are the metrics

associated with field evalua tion of therapies as pursued by the registrants of the

candidate bactericides.

 Reduction in C Las titer in infected trees followin g bactericidal regimen: The first measurable impact of bacter icidal treatment would be ex pected to be reduction in

bacterial titer in infected tissues. This is best meas ured at present using qPCR, and the numerical scale change s in samples over time refl ect increase or decrease in bacteria in tissues sampled. Following a time-course of bact ericidal treatments, it would be expected to s ee a gradual increase in P CR CT values, indicating a decline in titer in infected plant part s sampled. This may occur as step-wise reduction following individual applicatio ns, as evidenced in the data summaries provided. This in itself is not a metric of improved plant health or economic benefit, but portends resumption of gr owth and response as bacterial levels

decline.46  Improved tree growth response: Biological response to the le ssening of pathogen pressure in infected trees is manifest in a series of indicators that trees are returning to more normal gr owth and development. As in the description of the onset of disease symptoms above, the progressive lesse ning of disease injury would be expected to show itself through leaf, branch, root and fruit symptoms.

This has been observed in field experiments where th erapies (both chemical and thermal) have been applied, and specific field results are presented in this petition for the products being field tested.

 Foliage response: Larger, greener, more ro bust flush appear in flushing periods following treatment, and the degree to wh ich flushing phenology and the strength of new foliage resume a “normal pattern” is indicative of reduced disease.

 Canopy density improvement: Increased photosynthetic capacity is a by-product of new, healthy flush and drives plant he alth. Tree growth, including laying down of new phloem also can follow.

 Root health improvement: Photosynthate movement and lessening of root decline due directly to C Las follows resumption of tree flus hing, and it is yet unclear to what extent this will occur following a treatment regime of bactericides.

 Increased capacity to utili ze irrigation and nutritional applications, including improved foliar uptake. Restoration of ro ot health has immediate impacts on the tree’s ability to utilize nutri ents and healthy roots buff er periods of dry and wet

weather.

 Ability to combat other st resses (root disease, cold, drought). Resumption of balanced flush with restored roots has the added advantage of providing the defense against other stresse s that exist in groves. Overcoming these stresses also contributes to resumption of tree health and productivity.

 Fruit set and productivity: Since successful fruiting is dependent on support from the canopy, the above improvements in tree health can be expected to contribute to improved fruiting, and in conjunction with lower C Las titer, less size and fruit quality issues. Metrics associated with frui t yield, size and quality thus are direct

indicators of effect of treatment success.

It should be clear that expect ed response in diseased citrus trees from application of a regimen of bactericidal applic ations will first be improvemen t in bacterial titers, followed by reduced visual symptoms, th en impacts on the production and quality of fruit. While47 this is likely to occur across a full production season, it is also likely that accrued benefit of the suppression of C Las in infected plants will occur over multiple seasons.

While none of the above disc ussion pinpoints economic bene fit of grower use of the proposed bactericides in this petition, it provides the cont ext for that economic assessment. Based on the pr eceding discussion, improvement in tree health should lead to following economic drivers:

Fruit yield and quality improvement – Larger fruit set and retention through the production season; Increased capacity to hold fruit on the tree season-long; less pre-harvest fruit drop; Improved fruit size; Improved internal fruit quality; Normal growth progression fo r young trees (up to 5 years old) to full productivity (multi-year impact); and, Increases in new plantings with availabili ty of tools to deter disease progression.

Impacts at the Processing Facility:

The economic loss resulting from HLB-induced reduction of qu ality can be measured by downgrading, which initially can be done while fruit are still on the tree. Quality standards are established for juice fruit and fresh fruit harvest per fruit variety, and delays in maturity, caused by HLB infection, postpone harvest, an d allow an extended period for pre-harvest fruit drop to occur. Increasingly, ha rvesting of fr uit, even for processing, is not “clea n-picked”, where the en tire crop is removed at once, then graded and routed to fresh and processing streams. In the presence of HLB, fewer groves are harvested in this manner, and th e fruit left behind due to i rregular shape, small size, and other quality parameters is lost production.

Fresh-fruit harvest has traditionally used “spo t-picking” to begin the season, where fruit
of the desired size and maturi ty are harvested, allowing rema ining, smaller fruit to “size up” and mature for later harvest. Under HL B conditions, some gr oves from which fresh fruit are harvested are spot-pic ked 3 times, dramatically incr easing harvest and handling costs. In the past two seasons, fruit left after initial spot pi cking did not continue to size,
another result of HLB disease. Ultimately, the remaining fruit on these trees are cleanpicked for routing to processing plants.

The second stage for quality do wngrading comes at fruit load receipt at either packing houses (fresh) or processing plants (juice). Typically, fr esh packing operations sort, grade and pack cartons of frui t to specifications. The percent of frui t arriving at the packinghouse that ends up in cartons is referred to as pack-o ut. Even with spot-picking to select higher quality fruit, pack-out per centages have dropped 20 to 40% in the past 348 years. The fruit not pa cked into cartons is re directed to processing streams, resulting in
lower returns. For the 2014 fr uit season, oranges averaged $16.31/box when utilized for fresh and $12.09/box average for processing (USDA, NASS Florida Agriculture Quick Statistics). The differential is even greater for grapefru it, where 2014 fresh grapefruit were valued at an average of $14.44 per box for fresh and $6.38 pe r box for processing
utilization.

Fruit arriving at processing plants is samp led by load and the quality is assessed. The FDACS State Test House measures percent brix (sugar), percent acid and the ratio of brix/acid. This ratio is the in itial basis for juice quality, an d provides the quality data for payment to the grower. Additional data recovered from the lo ad sampling includes pounds solids per weight of fruit, percen t juice and overall weight of the load. The formula for payment is quality based and calcul ated for the pounds solids delivered from
the entire load.

HLB-affected loads of fruit net a lower brix and lower ratio, and due to smaller size, have less percent juice, yielding le ss juice from processing. Ba sed on the State Test House results, fruit loads are assigned a grade, and lower grades are discounted. In the case of shared pool processing situat ions, the grade determines yo ur “pool share” at season’s end, and this can be as much as 15-20 % disc ount for grade B compar ed to grade A fruit loads. The more serious impa ct is when lower grade loads of fruit are routed for juice concentrate production rather than inclusion in the not-from-concentr ate juice processing stream. A significant differential occurs between these two form s of orange juice utilization, and this varies by processor and by season.

All of these parameters have declined pr ogressively over the past 3 years, and are expected to continue in chro nically infected trees. Treatm ent to suppress HLB in these infected trees would be expected to reverse this process and restor e value for each of
these variables.

Impacts at the Fresh Fruit Packing House:

In addition to the impact on the processi ng industry, the fresh fruit industry has paralleled the losses due to HLB.

The loss in fresh utilization is due to:

 Tree loss

 Increased fruit drop

 Lower pack outs, due to smaller size and quality issues associated with HLB.49 Table 10: Reduction in shipments of Fresh Fruit Varieties in Florida as a result of the impact of HLB

Change 2014-2015 from 2007-2008

Variety Fresh Boxes (In 000) %

Reductions Oranges (476) -10.8% Grapefruit (4,645) -46.8% Tangelos (74) -46.1% Early Tangerines (730) -63.3% Honey Tangerines (909) -63.3%

All Fresh (6,834) -38.6%

Data sourced from: Duke Chadwell , Citrus Administrative Committee

For one Florida shipper, the 3-year average pack out (fresh utilization) for the 2005, 2006,
and 2007 seasons was 70.4%. The aver age pack out for the 2013, 2014, and 2015 seasons was 53.7%. This 16.7% pack out reduction is due to HLB impacts on the size and quality of fresh fruit produced from our groves.

Improving pack outs to pre-HLB levels woul d increase our company’s fresh output by 126,487 boxes, or 33.0%, without consi dering any potential yield increases.

Industry Wide Impacts:

The following is a summary of previously published and pr esented material supplemented

with data from the 2012-13 fruit season. Th is report was prepar ed by Bob Norberg, Economist, Florida Citrus Mutual, Economic and Market Research Associates, January 2014. It summarizes several pr eviously published reports re garding the economics of the Florida Citrus Industry and the impacts of HL B on Florida Citrus economics. Data from

the most recent seasons is us ed to generate supplemental impacts based on the logic from the previous reports.

The three factors examined in this economic evaluation were: tree mortality rates, replanting rates, and fruit yields. Reducing th e mortality, and/or increasing the replanting rate, and/or improving fruit yi elds all have positive econo mic impacts. The following chart shows the combined effects on crop size with gradual improvements to these factors over the next 10 years. Reducing the mortality rate from 4 to 3 percent in 10 years, increasing the planting rate from 2 percent to 3 pe rcent over 10 years, and raising yields 1 percent per year woul d generate a total of 140 million additional boxes of fruit

over the forecast horizon. Th ose additional boxes generate direct, indirect and induced economic impacts that would not be generated without them.50 The following chart from the presentation concludes that those boxes are worth $7.4 billion dollars during those te n years. Farm gate revenu es would be enhanced by $1.1

billion dollars.

Further increases in pre-season fr uit drop and reductions in fr uit size were forecasted in the January 2014 estimate highlighted in the ta ble above and are expected to continue that trend in future production estimates. The reduced yields have contributed to the smallest orange crop since th e freeze impacted crop of 1989/ 90. It is uncertain, but51 likely, that these yield effects will be seen in future seasons without dramatic advances in production management practices, disease miti gation strategies, and solutions from the comprehensive research efforts.

Update on Economic Impacts, January, 2014:

Using the methodology previously establis hed by Hodges and Spreen in their 2012 analysis, an updated estimate of the an nual economic impacts of HLB (and other calamities) can be calculated . Although unit FOB values have ri sen recently, these increases do not compensate for the loss of volumes since the value-added portion of total economic output is a sign ificant factor and is direct ly correlated to volumes of orange juice case goods produced and distributed.

The following table shows the losses to be $3.3 billion over the pe riod from 2011/12 to 2013/14 (January forecast) and 10,089 annual jo bs. Combined with the losses estimated previously, losses to da te from the 2006/07 season are $7.8 billion.

The annual rate of losses in both economic output and jobs is accelerating from the previous estimate. The average annual loss was $908.2 million per year between 2006/07 and 2010/11, while the annual loss rate for th e period 2011/12 to 2013/ 14 is $1.1 billion. Currently total economic losses versus a non-HL B forecast is estimated to be $1.8 billion for the 2013/14 season based on the January crop forecast.

Table 11: Impact of HLB to the Florid a Citrus Industry the three Previous

Seasons

CROP SEASONS 2011/12 –

2013/14 Non-HLB HLB Difference

FOB REVENUES (MM) $7,356 $6,103 ($1,253)

DIRECT ECONOMIC OUTPUT (MM) $7,088 $5873 ($855)

TOTAL ECONOMIC OUTPUT $19,245 $16,096 ($3,329)

ANNUAL EMPLOYMENT 58,865 48,776 (10,089)

This information has not been updated to include the 17 percent production loss experienced during the 2014-15 citrus season.52 ESTIMATED REVENUES FOR THE SITES TO BE TREATED (166.20(b)(4)(ii) & (iii)) (166.20(b)(4)(ii) & (iii))

Florida accounts for: 66 percent of the total U. S. value for oranges; 65 percent of the total U. S. value for grapefruit.

Florida currently ranks 1 st in the U.S. in the value of both the prod uction of oranges and grapefruit.

Table 12: Florida Production Information, Oranges

Florida Orange Production Information*

Season Total Bearing

Acres Total
Production

(1000 boxes**) Yield per Acre (total boxes) Price per

Box Total

On-Tree

Value (Millions)

2013-14 418,700 104,600 250 $7.58 $ 792.7 2012-13 429,200 133,600 311 $7.43 $ 992.5 2011-12 433,400 146,700 338 $9.92 $1,455.7 2010-11 440,000 140,500 319 $8.41 $1,181.9 2009-10 451,000 133,700 296 $6.96 $ 929.9

5-Year Average 434,460 131,820 303 $8.06 $1,070.5

* Source: Latest Available Florida Agricultural Statistics Service Citrus Summary, February 2015. ** Box = 90 pounds53 Table 13: Florida Production Information, Grapefruit

Florida Grapefruit Production Information*

Season Total Bearing

Acres Total
Production

(X 1000 boxes) Yield per Acre (total boxes) Price per

Box Total

On-Tree

Value (Millions)

2013-14 43,100 15,650 363 $6.44 $100.8 2012-13 44,900 18,350 409 $6.47 $118.7 2011-12 45,500 18,850 414 $7.17 $135.3 2010-11 46,500 19,750 425 $6.72 $132.7 2009-10 48,100 20,300 422 $7.50 $152.2

5-Year Average 45,620 18,580 407 $6.86 $127.9

* Source: Latest Available Florid a Agricultural Statistics Service Citrus Summary, February 2015. ** Box =85 pounds

Economics associated with HLB and potent ial impacts of Section 18 bactericidal

treatments:

Processed Oranges Metrics (>90% of Florida citrus Crop)

Table 14: Emergency Loss When compared to Baseline Florida Orange

Production Prior to HLB.

Factor Baseline (preHLB)

2005-06 2014-15 Harvest

Season Change (%) Bearing Orange Acreage 529,241 acres 441,628 acres -16.6 Annual Production (million boxes) 147,700,000 96,800,000 -34.5 Yields per acre (90 lb. box) 301 boxes/acre 250 boxes/acre -17 Fruit Size (average number/box) 221 (2007-08) 244 10.4 Pre-harvest fruit drop (Valencia) 15 % (2007-08) 25% 10

Source: USDA, Florida Agricu ltural Statistics Service54 Expected Benefit Due to Bactericide Treatments:

Expected impacts are calculated based on hist oric statistics and expected impacts of the proposed treatment on citrus productivity an d fruit quality. The factors that are most likely to show improvement follo wing season-long treatments as described in the petition are improvement in fruit size, retention of more fruit on tree, and re turn crop production

increases.

Reduction in Fruit Drop: One of the most devastating impa cts of HLB is loss of yield through fruit drop just prio r to harvest. The impacts of 20 percent and 50 percent reduction in fruit drop are calculated here.

A 20 percent reduction in the current 25 per cent fruit drop rate would restore five percent to harvested yield for the same crop load. This fi ve percent retention adds 12.5 boxes per acre and at $12.09, on -tree value of $151.13 per acre. That translates into 5,520,350 boxes of fruit saved from fa lling to the ground with a 25 percent reduction in the amount of fruit drop , and this is valued at $66,743,240 for

orange acreage per year.

Using the same calculations fo r fifty percent reduction in fruit drop would restore 12.5 percent to yield. This transl ates into 31.25 boxes per acre a dditional impact on yield and, at $12.09, is valued at $378 per acre per season. Calculated benefit across all orange acreage provides addition of 13, 800,875 boxes of fruit, or an economic benefit of $166,935,384 to Florida orange growers per season.

Similar calculations can also be made for othe r citrus varieties and for the added value of fresh market, especial ly for grapefruit.

Improvement in Fruit Size: HL B has reduced fruit size, an d tree health recovery is expected to improve fruit size . The impact is calculated for 20 percent reduction and 50 percent reduction in fruit size.

Comparison of fruit size show s 23 additional fruit were n eeded to fill a 90 pound box
because of HLB in 2014-15.

A 20 percent treatment improvement in fruit si ze would lead to 4.6 fewer fruit per box (239.4 fruit/box), across 250 boxes per acre , for a total of 1,150 pieces, and at 239.4 fruit/box, this would add 4.8 boxes per acre. The per-acre economic benefit of a 20 percent change in fruit size reductio n would lead to 4.8 boxes x $12.09 (ontree price, 2014-15) or $58.03 per acre. Across all orange acreage (441,628 acres), this benefit would be 2,119,814 additional boxes of oranges, and $25,628,556 per season for just this minor improvement to fruit size.55 A 50 percent treatment improvement in fruit si ze reduction would similarly lead to 11.5
fewer fruit needed to fill a 90 pound box (232.5 fruit), ac ross 250 boxes per acre, for a total of 2,875 pieces, and at 232. 5 fruit/box, that improves yi eld by 12.4 boxes per acre. The per-acre economic benefit of a 50 percent change in fruit size reduction

would therefore lead to 12.4 additional boxes x $12.09, or $149.50 per acre. Across all orange acreage, this wo uld add 5,343,699 boxes of yield worth $64,605,321 per season at 2014-15 prices.

Similar calculations could be developed for non-orange varieties, and additional value could be calculated for considering fresh fruit value-added for the port ion of the crop that
is marketed fresh.

Both of the above improvements to orange yi elds are possible within the existing crop load of fruit, and reflect within season im provements that could occur with effective
bactericidal treatment. Additional value co uld be obtained with expected improvements in fruit quality (brix/acid ra tion, pounds solids and flavor-i mpacting components. These
benefits are not included in the size and fruit drop considerations above.

Improved annual production (su ccessive years): In crop ye ars following application of the emergency treatments, it is expected that restored tree health would lead to higher fruit set and increased yields above and beyond the benefits discussed above.

Calculations of the value of this fo r varying rates of improved yield are:

Five percent yield response would increm ent yield of 250 boxe s to 262.5 per acre, or an increase of $151.13 per acre. The all-orange impact would be 5,520,350 boxes and $66,736.800 pe r season, the same benefit (additive) to the reduction in fruit drop.

10 percent yield response would increment yield of 250 boxes by 25 boxes per acre, or $302.25. Across all orange acres, this 10% improvement in current tree productivity would a dd 11,040,700 boxes of fruit and an

economic benefit of $133,482,063 per season.

25 percent yield response nets 62.5 boxes per acre additional fruit, or $755.63 per
acre benefit. Across all orange acreage, this estimated benefit is 27,601,750 boxes, or when added to 2014-15 season yields, 124,401,750 boxes per season.

The estimated economic value of the additional production improvement of 25 percent is $333,705,158 per season.

The actual benefit can be approximated by adding the improvement in fruit drop reduction, increased fruit size, and finally the gain in production that treatment to
reduce C Las titer in infected trees might bring. Again, thes e calculations represent oranges and the acreage currently dedicated to this major elemen t of the industry. Similar composite benefits could be calculated.56 Using the minimal improvements calculated above (20% reduct ion in fruit drop, 20% improvement in fruit size reduction an d 5% production incr ease in new crop)
the economic benefit calculat ed for the orange acreag e in Florida is $66,743,240 + $25,628,556 + $66,736,800 or $159,108,596 per season.

Finally, the treatment benefits would encourage new plantings, and the new benefit would then by be multiplied as new plantings come into production.