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5
Strategies for Implementing Plans for Mitigation of Huanglongbing and Other Problems in Citrus Production

IMPLEMENTING PLANS FOR HUANGLONGBING MITIGATION

Implementation in Other Industries

Inevitably, the organization and structure of the Florida citrus industry, as well as federal and state agencies, have molded the structure, shape and direction of research and development (R&D) intended to benefit the industry. As the citrus industry has developed, it has become increasingly dependent on R&D. The structure of the citrus industry contrasts with the structure of a typical R&D-dependent industry, which is made up of individual companies, each with its own captive R&D capability, both in-house and outsourced. Company R&D management is responsible and accountable for producing or procuring next-generational product advancements and improvements that will provide a competitive advantage relative to other companies in the same sector. R&D management also is charged with solving the technological problems that invariably arise in the course of the company’s business. It is management’s ultimate responsibility to prioritize, allocate, and, when conditions change, redistribute R&D resources in a manner that best serves the company’s interests. R&D decision- making is facilitated by overall milestones and development phases incorporated into an overarching strategic plan which is intended to ensure that new products and services enter the market with critical delivery timing. The strategic plan and progress against milestones are reviewed on a regular basis across all stakeholders to ensure goals will be met. The Florida citrus industry has several characteristics that distinguish it from the model described above. The Florida citrus industry is necessarily fragmented because it consists of dedicated fruit producers who operate independently. The producers do not have a captive R&D function, per se. Rather, they rely on a system of research grants from a number of different sources, including their box tax contributions, to sponsor and drive research. Consequently, the sources of research funding are also fragmented. This structure, a natural consequence of widely dispersed ownership of the means of production, presents challenges to achieving focus, balance and integration in R&D topics, goals and lines of responsibility and authority. Decision-making tends to be slow and bureaucratic and not well-suited for crisis management.



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5 Strategies for Implementing Plans for Mitigation of Huanglongbing and Other Problems in Citrus Production IMPLEMENTING PLANS FOR HUANGLONGBING MITIGATION Implementation in Other Industries Inevitably, the organization and structure of the Florida citrus industry, as well as federal and state agencies, have molded the structure, shape and direction of research and development (R&D) intended to benefit the industry. As the citrus industry has developed, it has become increasingly dependent on R&D. The structure of the citrus industry contrasts with the structure of a typical R&D-dependent industry, which is made up of individual companies, each with its own captive R&D capability, both in-house and outsourced. Company R&D management is responsible and accountable for producing or procuring next-generational product advancements and improvements that will provide a competitive advantage relative to other companies in the same sector. R&D management also is charged with solving the technological problems that invariably arise in the course of the company’s business. It is management’s ultimate responsibility to prioritize, allocate, and, when conditions change, redistribute R&D resources in a manner that best serves the company’s interests. R&D decision- making is facilitated by overall milestones and development phases incorporated into an overarching strategic plan which is intended to ensure that new products and services enter the market with critical delivery timing. The strategic plan and progress against milestones are reviewed on a regular basis across all stakeholders to ensure goals will be met. The Florida citrus industry has several characteristics that distinguish it from the model described above. The Florida citrus industry is necessarily fragmented because it consists of dedicated fruit producers who operate independently. The producers do not have a captive R&D function, per se. Rather, they rely on a system of research grants from a number of different sources, including their box tax contributions, to sponsor and drive research. Consequently, the sources of research funding are also fragmented. This structure, a natural consequence of widely dispersed ownership of the means of production, presents challenges to achieving focus, balance and integration in R&D topics, goals and lines of responsibility and authority. Decision-making tends to be slow and bureaucratic and not well-suited for crisis management. 127

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128 STRATEGIC PLANNING FOR THE FLORIDA CITRUS INDUSTRY The health care industry also has a dispersed structure. Individual physicians represent a highly fragmented “industry”. In times of a health care crisis a central authority, often the Centers for Disease Control, takes charge and provides national, or even international, leadership. The authority takes on a highly focused, high urgency tactical and strategic role and helps to coordinate initiatives already underway at state and local levels. Since huanglongbing (HLB) is an international problem, and without question of great relevance to the Americas and US, a strike-force like structure may be helpful to coordinate activities, maximize resource impact, and to set research direction, priorities, and review progress toward providing a sustained solution to HLB and other technical challenges posed to the citrus industry. Experience in health care may provide guidance to the citrus industry under the concept of best practices. The intent of a best practices approach is to observe efforts within and between industries in order to identify those practices that produce improved results. Clinical researchers closely track results of trials of a rigorously defined new treatment protocol, trials that often include direct comparison against the current treatment of choice. Results are offered to the medical community for critical consideration. When the data convincingly demonstrate the superiority of a new protocol, the new protocol is expected to replace the old and become the treatment of choice. In the case of HLB, the identification of best practices offers relatively near-term benefits. Practices elsewhere that are documented to produce a better result in some aspect of crop management can be adapted and applied to Florida crops fairly quickly. An important byproduct of best practices documentation is its ability to influence and shape public policy relevant to the citrus industry. For instance, politically contentious environment management techniques (e.g., mandated destruction of diseased trees and abandoned orchards) used elsewhere with success can lend graphic support for similar practices in Florida. Achieving Agreement in Support of Implementing Plans It is generally agreed that a concerted effort must be made to reduce the impact of HLB in the near- and intermediate-term, and there is general acceptance of three parts to current HLB mitigation efforts (Brlansky et al., 2009), as discussed in previous chapters: use only nursery stock that is free of Candidatus Liberibacter asiaticus (CLas), detect and remove infected trees, and manage the Asian citrus psyllid (ACP) vector. Pathogen-Free Nursery Trees The Citrus Health Response Program developed protocols for production of disease-free trees. As of January, 2008, all citrus nursery trees in Florida are required to be produced in screened enclosures from pathogen-free budwood and rootstock seed. These procedures have been highly effective in eliminating the spread of HLB by commercial nursery stock. Movement of the disease with ornamental plants such as Murraya has also been greatly reduced. The CLas- free tree program must be counted as an implementation success. Detection and Removal of Infected Trees Identification and removal of diseased trees is absolutely essential in any program of HLB mitigation, but, especially in the northern and central areas where incidence until very recently has been low, the practice has not been fully implemented, as it should be. The need to remove

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STRATEGIES FOR IMPLEMENTING PLANS FOR MITIGATION OF HUANGLONGBING 129 infected trees creates a hardship, especially for small growers. Some growers are now abandoning tree removal programs since they have proven costly and the incidence of HLB has continued to rise. However, at Southern Gardens, the first and originally the most seriously affected plantation, that practice continues to be effective. In their experience, even with a rigorous tree removal and psyllid control program, HLB incidence initially rises due to the long latent period of the disease. Only after 2–2½ years of such practices is the incidence of HLB substantially reduced (M. Irey, United States Sugar Corp., Clewiston, FL, personal communication). Current attempts to maintain production by applications of nutritional and anti- bacterial materials are completely understandable from the point of view of the individual grower but are counter-productive to the interests of the industry as a whole. In addition, efforts should be made to encourage the removal of abandoned groves wherever possible. Once incidence in a grove reaches 5–10 percent, removal of trees is unlikely to deter the rate of spread of the disease sufficiently to be sustainable. Homeowners should be encouraged to eliminate citrus as an ornamental and replace it with other fruit trees and ornamental shrubs. To reduce inoculum to a level that will allow a return on investment from replant trees will require implementation of tree removal on an area-wide basis (Recommendation O-1). Control of the Psyllid Vector (Recommendation NI-1) There are many issues related to ACP suppression. For insect-transmitted diseases such as HLB, ACP must be suppressed to low levels to reduce spread of the disease. Sufficiently low levels are unlikely to be achieved in continental areas with biological control alone. Nevertheless, maintenance and protection of biological control species, including those remaining in abandoned groves, is necessary to reduce populations of ACP and other insect pests year round. Whenever possible, products which have the least effect on beneficials should be selected and application timing should take their life cycles into account. More economical and environmentally friendly low-volume and aerial applications of insecticides and the rotations of insecticides with different chemistries, to reduce development of insect resistance, have been and are being developed. Fortunately, a large number of soil-applied and foliar insecticides are available for ACP control and inclusion in recommended insecticide protocols (Rogers et al., 2010). What practices should be followed? Given the severity of the HLB problem, some growers will continue to treat in a prophylactic manner and when populations are high based on trap counts. However, recent work has shown that well-timed sprays during the dormant period can be very effective at reducing the critical spring ACP population, and dormant period applications may make it possible to reduce the overall number of annual sprays. Well-timed sprays during flushes of growth also can be very effective in reducing ACP populations. Implementation of ACP suppression programs will be best accomplished using an area-wide management approach (next section). Area-wide Management Programs (Recommendation O-1) Area-wide management programs are important, even essential, for effective mitigation of HLB in Florida. Experience in both Brazil and Florida indicates that it is difficult to control HLB if neighboring groves have high levels of the disease (Belasque Jr., 2008). Thus, it will be important for neighboring growers to coordinate their efforts for both ACP suppression and tree removal. Implementation of area-wide management programs will require local support and

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130 STRATEGIC PLANNING FOR THE FLORIDA CITRUS INDUSTRY support from the entire industry as well. Only by implementation of an area-wide approach is it likely that best practices for both infected tree removal and ACP suppression will be disseminated and enforced. ACCELERATING PRODUCT DEVELOPMENT AND COMMERCIALIZATION: GRANTS VS. CONTRACT PRIZES AND ALTERNATIVES Alternative Models for Support of HLB Research The Florida citrus industry has correctly identified research as the vehicle to deal with HLB. An open question remains as to whether the type of research being supported is in balance or will be adequate to the challenge. When the knowledge needed to solve a particular problem does not exist within an organization1, various methods may be used to build that knowledge. For an individual company, existing internal R&D capability may be expanded to include initiatives that may be expected to plug knowledge gaps. This approach is often applied when the nature of the knowledge to be gained is central to the organization’s strategic interests, the discoveries are progressive, the new knowledge gained can serve as a building block on which additional progress through can be built, internally developed results are key to gaining competitive advantage and outright ownership of intellectual property (IP) and maintaining proprietary technical expertise. In other circumstances, and when the industry consists of many independent operators, outsourcing research may be more effective. Research may be outsourced under any of four types of agreements (Table 5-1). Implementing any of these may have great potential for stimulating research results that significantly advance the mitigation of HLB. Research Grants Research grants, most often made to universities, or government or private research institutes provide a way to support formation of a solution. This is especially true if the solution is in the category of a breakthrough or a long-standing, widely recognized unmet need. A key characteristic of research grants is that the deliverables are only directionally specified by the sponsor and a distinct, actionable solution to the articulated problem may or may not result. What is expected of the grant recipient is a certain level of effort dedicated to the topic that results in original research. The research leads to relevant publications, possibly patentable intellectual property, papers, reports and presentations. Research grants contribute to the preexisting knowledge base and may reach a tipping point that actually solves the underlying problem. This research is most often performed at arms length from any R&D laboratory that the sponsor may have. Depending on provisions negotiated between the sponsor and grant recipient, commercialization rights and preferential access to IP may be stipulated. Because sponsored research grants most often result in new knowledge rather than a breakthrough innovation that 1 Organizational and internal for purposes of this section are meant to apply also to the decentralized R&D initiatives taking place in academic settings on behalf of citrus growers and governmental agencies.

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STRATEGIES FOR IMPLEMENTING PLANS FOR MITIGATION OF HUANGLONGBING 131 TABLE 5-1 External Research Vehicle Characteristics Grant Sponsored Research Contract Inducement Research Prize Solve specific Nature of task Fill knowledge gap or Fill knowledge gap; Solve problem; output identify an entirely experiment driven specific driven new research problem; direction; experiment harvest driven knowledge Few Few Few Possibly many Number of potential solvers Risk bearer Sponsor Sponsor Sponsor Solver Sponsor Low Low to moderate High Low control New knowledge; occasional Specified Specified Output New knowledge; breakthrough deliverable deliverable if occasional winner emerges breakthrough Intellectual University/researcher Negotiable among Sponsor Sponsor property university/researcher/sponsor ownership Confidentiality Low Low High Moderate to- high Urgency/speed Low Low to moderate High High; deadline driven Work plan Directional, discovery Directional, discovery Roadmap, Opportunistic, driven, iterative driven, iterative schedule hit or miss driven has direct commercial application, such grants by industry sponsors are often considered a form of philanthropy that serves society, enhances company image, and may serve the company’s R&D self-interest if something having commercial utility happens to result. From the perspective of industry, research grants are viewed as supporting pre-competitive basic and to a lesser degree, applied research. It is for this reason that most research grants at US universities are not sponsored by industry, but rather by the federal government through various agencies such as the National Science Foundation (NSF), National Institutes of Health, Department of Defense, Department of Energy, and the US Department of Agriculture (USDA). On occasion, foundations, trade organizations, and affiliation groups may sponsor research grants. The Florida citrus industry is an excellent example of this latter circumstance. Individual growers contribute to research grants via an allocation process, in this instance tied to a “box tax” (RGG, 2009; USDA-CSREES, 2009).

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132 STRATEGIC PLANNING FOR THE FLORIDA CITRUS INDUSTRY Sponsored Research Sponsored research, compared to grants, places a greater emphasis on applied research. It is a nuanced form of a research grant. The sponsor selects this structure in instances where the external academic laboratory has highly specialized expertise, often in the form of sophisticated equipment, analytical techniques, or cutting edge know-how that complement those of its own laboratories. In this variant of a research grant the sponsor and the university laboratory anticipate a higher degree of interaction between the academic laboratory and the sponsor’s technical staff, including possible intellectual property commingling. Relative to a grant, sponsored research makes greater use of schedules, milestones, and details about ownership of outputs. The sponsor is eager to avoid the circumstance in which its independently produced know-how or even trade secrets flow to a competitor. The sponsored research agreement places great emphasis on confidentiality and review of manuscripts prior to journal submission. The sponsored research mode often is selected when the sponsor has a sense of urgency about a project. Contract Research Contract research, as its name implies, is performed under a legally binding agreement between the parties. It states the sponsor will pay the outside researcher a predetermined fee for specific services. Unlike the sponsored research contracts discussed above, contract research is considerably more prescriptive. It can involve university researchers or private research organizations. Intellectual property that may arise is usually owned by the sponsor or assigned exclusively to the sponsor. Publication rights may be at the discretion of sponsor. Some would argue that contract research is really more in the realm of development than research per se because the recipient may believe that it has within its control the know-how to produce the deliverables stipulated in the contract. In any event, it is an effective tool by which to expand currently existing capabilities of the sponsor because it permits the sponsor to tap into expertise it does not and cannot easily possess. By arranging multiple contracts on the same topic, the sponsor may create parallel paths toward a solution of a difficult problem to improve the chances of success. Inducement Prize Some “problems” have proven to be particularly vexing for an industry or society. The solution is elusive for those closest to it, both internal and external to the sponsor. In such instances, the use of inducement prizes may prove effective. Described simply, inducement prizes are created by an announcement to the public in the form of a detailed description of the problem to be solved, a specification of what constitutes a solution and usually a deadline for submission of proposed solutions. A team of judges selects which solution, if any, merits awarding of the prize. In some instances awards can be offered for the first practicable solution submitted and to the best solution provided prior to the deadline (Hotz, 2009; McKinsey and Company, 2009). The use of inducement prizes is not new. In 1714, the British Parliament created The Longitude Prize for a solution that could provide longitude information on board a ship out of sight of land to within ½ degree. A prize of £20,000, a substantial amount in that day, was offered. Eventually in 1773, William Harrison was determined to be the winner of the prize,

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STRATEGIES FOR IMPLEMENTING PLANS FOR MITIGATION OF HUANGLONGBING 133 although his chronometer-based innovation was shown to meet the award specification much earlier. A food preservation prize was created by Napoleonic France that resulted in the canning process that is still in use. More recently, The Ortig Prize of $25,000 was offered for the first non-stop flight between New York and Paris. Charles Lindbergh won the Ortig Prize for his flight on May 21–22, 1927. Inducement prizes are in resurgence. An estimated combined purse in 2007 of $165 million was available in the science, engineering, climate, and environment sectors out of a total of $315 million (also including aviation, space, arts, and others). The success rate for inducement prizes is relatively high. According to Karim Lakhani from the Harvard Business School, out of 166 problems posted by a firm specializing in the creation of inducement prizes for clients, nearly 30 percent of the problems were successfully solved. Although sometimes criticized for being overly commercial and even frivolous, inducement prizes have gained respectability. In 1999, a National Academy of Engineering workshop endorsed the concept (NAE, 1999). In 2007, the National Research Council issued a report, “Innovation Inducement Prizes at the National Science Foundation,” that recommended the use of such prizes to strengthen the innovation engine in the US and that the NSF adopt this approach among its more traditional funding methods (NRC, 2007). Currently offered inducement prizes carry substantial awards. They are often over $100,000 and range into the millions of dollars. Since the prize is only awarded for success, the financial risks to the sponsor are relatively low, amounting to administrative and promotion costs if no solution emerges. In fact, risk is transferred to those choosing to participate. Another advantage of such prizes is they draw interest from individuals and teams outside the usual community of scientists associated with the problem. Talent that is geographically dispersed and may not be known to the sponsor can also participate. Such prizes bring fresh eyes to the problem, and they can leverage technologies already developed in other industries. Also, outsiders are not unduly biased by “conventional wisdom” that may serve to limit avenues of exploration for a solution. The deadline of an inducement prize imposes a desired sense of urgency. In these ways inducement prizes cast a wide net for practicable solutions to vexing problems. A number of unresolved aspects relating to HLB have the potential for accelerated resolution via the inducement prize route. Approaches that would significantly delay the spread of HLB or extend the economic viability of commercial orchards without maintaining sources of CLas are highly desirable. Writing the specifications for an inducement prize that would encourage discovery of such approaches would be challenging. As described elsewhere in this report, a mobile, non-contact sensor system that would identify infected trees as the sensor was driven past trees could aid in early removal of infected trees and slowing spread of the disease. Another example is an award for culturing CLas for a specified number of generations and providing the growth media and cultured pathogen available to the scientific public. A prize could be created for developing and introducing into citrus a gene for resistance to CLas or ACP, with specifications of success in fewer than the 10 years now anticipated for this accomplishment and for minimal alterations to the varietal type. Each type of research support structure offers different levels of accountability, speed, risk, and desired outcome. Current initiatives are heavily weighted in the grant category, which arguably may be overweighed. Figure 5-1 presents a decision tree to aid in the selection of the type of external research approach that best suits a given type of research or development objective.

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134 STRATEGIC PLANNING FOR THE FLORIDA CITRUS INDUSTRY INTELLECTUAL PROPERTY MANAGEMENT WITH THE AIM OF STIMULATING DEPLOYMENT OF HUANGLONGBING TECHNOLOGY Intellectual property (IP) is a widely used term. The term also has precise meanings rooted in US and international law. Intellectual refers to a product of the human mind. Property connotes something that the “owner” can sell, license, rent, hold exclusively for him/herself, trade, or even give away. Governments have long recognized the importance of IP as a vehicle to encourage innovation and to contribute to society’s advancement. In an effort to encourage individuals to take technical, scientific, agricultural, and other forms of creative risk, governments offer limited monopolies for useful discoveries and creative works. Patents are the oldest form of such intellectual property rights. Although the exact origin of a patenting system is unclear, it is generally believed a rudimentary system began in Renaissance Italy to protect innovations in glass blowing developed by Venetian artists. This system spread to other parts of Europe. The first recorded patent was awarded in 1449 to John of Utynam by the English government for a novel method to manufacture stained glass (Thompson Reuters). The framers of the US Constitution recognized the importance of intellectual property for a developing nation. Article 1, Section 8 of the Constitution states: “The Congress shall have power… to promote progress of science and useful arts by securing for limited times to authors and inventors the exclusive right to their respective writing and discoveries.” Patents are the most recognized type of IP. IP can also take the form of trademarks which protect product “brands”; copyrights which protect written works, artwork, music, presentations, and similar forms of unique expression; or trade secrets, usually reserved for commercially relevant recipes, formulas, or processes (www.wipo.int/about-ip/en). The criteria for obtaining a patent are highly technical and are beyond the scope of this report. It is, however, relevant to present briefly several key aspects of patents that may not be widely understood and have relevance in the context of HLB. The granting of a patent by the United States Patent and Trademark Office (USPTO) is an exclusionary right. That is, the owner of a valid patent secures for the statutory lifetime of the patent the right to keep others from making, selling, or distributing the specifically defined inventive subject matter, known as the “claims”, of the granted patent. It does not confer on the owner the right to actually make, sell, or distribute, except in certain circumstances. An example is needed here. Let’s say the inventor develops the idea of and method for manufacturing a white sidewall tire for cars. She submits to the USPTO the properly drafted and executed application, usually prepared by a patent attorney. After a determination by a patent examiner at the USPTO (a process that is very exacting, thorough, and may take a few years) that the application represents a useful and novel innovation, the inventor is granted a US patent for a white sidewall tire as articulated in the claims. Can the inventor now sell white sidewall tires? The answer depends on the circumstances. If someone already holds a valid patent on a tire for which the whitewall version is an improvement, the answer is “no”, unless she secures permission (usually in the form of a license) from the owner of the “prior art” tire patent her invention builds upon. The answer is “yes” if there are no prior art patents that her invention builds on still in force (that is, relevant prior art tire inventions have expired or never existed), or if hers is a fundamentally new breakthrough idea.

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STRATEGIES FOR IMPLEMENTING PLANS FOR MITIGATION OF HUANGLONGBING 135 FIGURE 5-1 Decision tree for using an inducement prize rather than other types of research or development support. Exhibit taken from McKinsey and Company, 2009. The example above brings out the notion that many patents represent improvements to already existing core ideas. The ability to create and gain patent protection for an improvement on a patented item is a fundamental benefit underlying the concept of a government-issued patent. In return for a limited monopoly on the inventive subject matter, the inventor, as part of the application process is required to teach the world how to make and practice his/her invention. In fact the inventor is obligated to enumerate the best teaching known to him/her. This requirement enables another person to understand the technology underlying the granted patent and, if capable and so motivated, to invent an improvement, thereby spurring technological progress for the benefit of society. Patents are an important element of the commercialization process, but within a context. The patent requires the innovative “flash of light”, but many more steps are required to “reduce to practice” and actually commercialize the concept into a product that relies on the patented invention. Matters such as robust design, manufacturability, scale-up, cost to produce, reliability, safety, effectiveness, and securing of regulatory clearances and registrations must be resolved as part of the commercialization process. All of these factors represent financial and opportunity risk for the manufacturer. Absent patent protection, owned or licensed, which keeps fast followers from simply copying successful innovations, companies would have few incentives to invest in the risky, costly and time consuming commercialization process.

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136 STRATEGIC PLANNING FOR THE FLORIDA CITRUS INDUSTRY The HLB Research and Development Enterprise and Intellectual Property Effective management of HLB will require a multi-pronged approach. Measures such as scouting for early signs of infection, prompt removal of diseased trees, the use of disease-free nursery stock, and other crop management practices generally are in the public domain, as are public policies and regulations regarding disposition of abandoned groves and ornamental plantings. Other aspects, such as genetically modified trees, new insecticides targeted at controlling the psyllid vector, new antibiotic preparations, or novel detection technologies require careful consideration of IP, particularly patents. These later aspects require a costly development cycle to bring them to market. In some instances navigation of and investment in complex regulatory processes to prove safety and effectiveness are also mandatory. Research aimed at growing an understanding of HLB and for ways to mitigate or even cure the disease is highly distributed in the US and around the world. Sponsors of important research are also large in number and only loosely affiliated and coordinated, if at all. While most research initiatives are unlikely to have direct commercial applicability (note: this in no way impugns the scholarly importance of the work) research which does result in patentable discoveries need to be handled correctly if patents are to be sought. It must be emphasized again that without protective patents in place, companies will be very reluctant to invest in developing new technologies, particularly if there are large pre-investments required. Granting organizations need to articulate in their award documents expectations and responsibilities regarding inventions, if they do not already do so. It is also important to impress upon researchers, their staff, and host institutions the fundamentals of securing patents. Researchers must know what steps they need to follow in order to comport with the rigorous application requirements set forth by the USPTO and patent bodies elsewhere. A number of actions by the inventor(s) may serve to bar patent eligibility or invalidate their already issued patents. Among the most common of these are: premature public disclosure of the invention and listing the wrong inventors in the patent application. The US patent law requires that the inventor must file a patent application no later than one year after a public disclosure of the invention. European law and most of the rest of the world requires an application be filed in their jurisdiction before a public disclosure of the invention2. Premature public disclosure of the invention often comes in the form of a presentation or literature publication. Submitting a presentation abstract, assuming it discloses the invention, to symposium organizers or an article for review by journal editors can serve as a statutory bar to eventual patenting or be the event that invalidates a patent already issued if filing steps and timetables were not satisfied. Disclosures via guest lectures, letters, informal conversations with individuals not directly involved with the invention (e.g., support staff, technicians), or offers to sell the invention may also be sufficient for a public disclosure to have occurred (MIT-TLO, 2006). Failure to accurately identify the list of inventors may invalidate a patent. Criteria and legal standards for inventorship are set by the USPTO and similar offices in other geographies. Determination of the legal inventors is a task best left to a patent attorney following interviews with individuals associated with the invention. Not all potentially patentable ideas should be submitted for patenting. The subject matter 2 Some technicalities apply regarding a “priority patent application” but are beyond the scope of this discussion. Suffice it to say an oral or written public disclosure may serve as an absolute bar to receiving a patent or invalidating one previously issued.

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STRATEGIES FOR IMPLEMENTING PLANS FOR MITIGATION OF HUANGLONGBING 137 may be too narrow, too esoteric, or perhaps too impractical. What’s more, securing a patent is very expensive. Technology-based patents can cost upwards of $20,000 to secure. Many countries impose periodic maintenance fees for already issued patents. While the fee for any one invention may be relatively small, organizations holding many patents must consider whether the fees in aggregate are affordable. It is not uncommon to allow a patent lapse by not paying the maintenance fee due to well thought-out business reasons. Reasons include lack of present and strategic relevance, inability to secure licensees, lack of competitive advantage offered by the patent, and so forth. Deciding what to patent is difficult. Large companies usually employ internal patent review boards to prioritize inventions. Patent board members include at least one patent attorney and typically representatives from engineering, marketing, and corporate development. Patent boards must possess both tactical and strategic expertise concerning not only technology but also the potential market for goods or services exploiting the patent. HLB research has both industry and government sponsors and is carried out primarily at academic institutions with disparate IP policies, making a centralized patent board impractical. Nevertheless, it is important that each funding source is aware of the role that patents play in the search for solutions to the HLB scourge and for each funding source to articulate patent strategies for their grant awardees that will preserve commercialization incentives. Regulatory Approval With transgenic citrus development as one of the research areas currently being funded by the citrus industry, it is imperative that IP and regulatory approval issues are considered by the industry early on. The previous section underscored the importance of seeking patents to protect IP. However, also of great importance is a Freedom to Operate (FTO) audit which will determine if patent infringement has occurred during the development of transgenic citrus. As pointed out by Bennett (2009), citing “Golden Rice” as an example of a transgenic crop that was found to have infringed on 70 proprietary technologies during its development (Kryder et al., 2000), patent infringement has serious consequences on the commercialization of the transgenic crop. Aside from this, navigating the complex process of deregulation also merits considerable attention. To date, USDA Animal and Plant Health Inspection Service (APHIS) has deregulated (i.e. made accessible to growers and consumers without the need for a permit) only two transgenic tree species, papaya (Carica papaya) and plum (Prunus domestica). The development of transgenic papaya (SunUp and Rainbow), with resistance to the papaya ringspot virus (PRSV), began in the mid 1980s; the deregulation process began in 1995 and was completed in 1997 (Gonsalves, 2004). The development of transgenic plum (Honeysweet), with resistance to Plum Pox disease, a viral disease transmitted by aphids and by grafting, spanned 15 years; it was deregulated by APHIS in 2007 (Scorza et al., 2007). Three federal agencies are involved in the deregulation of a transgenic crop, USDA-APHIS, which has authority over the cultivation of transgenic crops, the Food and Drug Administration, which has authority over transgenic crops that are used as food, and the Environmental Protection Agency which has regulatory authority over transgenic crops that provide protection against pests and diseases. The deregulation process is complex and, as shown the by the examples above, may take as little as two years to as much as 15 years to be completed. According to Bennett (2009), the lack of “a dedicated staff and expertise” available to the researcher seeking to deregulate his or her transgenic crop contributes to the inefficiency of the

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138 STRATEGIC PLANNING FOR THE FLORIDA CITRUS INDUSTRY process. Patent infringement and other intellectual property issues that can impede the development and commercialization of transgenic crops can now be more capably addressed by the public sector with assistance from institutions such as the Public Intellectual Property Resource of Agriculture. With regards to achieving a deregulated status, there is one program that was specifically established to provide help with navigating the regulatory process for transgenic specialty crops. In their website, the Specialty Crops Regulatory Assistance is defined as “a collaborative, public-private effort to assist public and private-sector developers of biotechnology-derived specialty crops in their efforts to complete the complex US regulatory process for commercialization of biotechnology-derived crops” (http://www.specialtycropassistance.org). Below are strategies that Bennett (2009) has recommended, some of which may have already been taken up by the citrus industry: • Adopting a translational research philosophy • Identifying partnerships that can integrate complementary technologies • Establishing an IP policy for HLB research • Establishing relationships with regulatory agencies Preparing for HLB Management Based on Genetically Modified Citrus As has been noted previously at several points in this report, the development of CLas-and ACP-resistant citrus varieties, or citrus rootstock that confers resistance on the scion, presents the greatest hope for a viable long-term solution to the HLB problem. At this time, there is no obvious path to achieving this goal by conventional citrus breeding. Therefore, approaches are favored that are aimed at developing transgenes capable of conferring resistance and introducing them into appropriate citrus lines. There are technical challenges associated with identifying effective transgenes and introducing them into citrus, particularly introducing them into mature citrus so that stock for budding or planting can be made available in a reasonable period of time. It is likely that these challenges can be met in the next few years. The difficulties in obtaining on IP and FTO are presented in the previous section, as are approaches to overcoming these difficulties. Should all of the technical and IP requirements be satisfied, there remains the potential barrier of unfavorable public acceptance. In 2008, the thirteenth year of commercialized transgenic crop production in the US, transgenic plantings had expanded to 154 million acres (62.5 Mha) and include field crops (soybean, corn, cotton, canola, alfalfa, and sugarbeet), a vegetable crop (squash), and an orchard crop (papaya) (http://www.isaaa.org/resources/publications/briefs/39/executivesummary/default.html). More than 90 percent of the 2008 US soybean crop was accounted for by transgenic, herbicide-tolerant varieties. Given the ubiquity of soybean derivatives in processed foods, there probably are very few residents of the US who have not consumed transgenic soybean. More than 60 percent of the cotton and corn crops were transgenic, providing additional transgenic dietary contributions. These facts do not mean that transgenic foods are fully accepted by consumers in this country. The organic food industry’s niche exists in large measure because of the claim that organic food is “GMO-free.” Several well-known activist organizations have taken a stance against genetically modified foods in general and would likely attempt to raise opposition in the general public to juice from transgenic oranges.

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STRATEGIES FOR IMPLEMENTING PLANS FOR MITIGATION OF HUANGLONGBING 139 Citrus appropriately has a reputation for providing health-benefitting products. This reputation, as helpful as it is in marketing citrus, may not be helpful in achieving public acceptance of products derived from genetically engineered citrus. What may be helpful is that the consumers of Florida orange juice almost all reside in the US, possibly the industrialized country that has been the most accepting of transgenic crop products. Although transgenic versions of minor crop species have been created no genetically engineered minor crop plant, other than squash and papaya, has been deregulated for commercial production. Possibly the only approach that could smooth the path for public acceptance of transgenic citrus products would be a fact-based, carefully vetted public education campaign that reveals the benefits of transgenic crop production. These benefits include a substantial reduction in pesticide use and production costs associated with these crops and, in some instances, even the ability to grow the crop in a particular area. Clearly, this education effort should not be borne by the citrus industry alone but could be an appropriate program of a consortium of minor crop producers who may anticipate benefits from transgenic versions. CONSEQUENCES AND BACKUP PLANS SHOULD HUANGLONGBING COUNTERMEASURES PROVE TO BE INSUFFICIENTLY EFFECTIVE The Florida citrus industry is an important component of the state’s economy. Its economic impact is estimated at $9.3 billion. The industry provides approximately 80,000 full-time equivalent jobs (grove employees, seasonal pickers, haulers, processors, and packers). These workers earn a combined annual wage of $2.7 billion. This translates into approximately 1.5 percent of the state’s wage income (Norberg, 2008). While some may view the affected stakeholders fairly narrowly (i.e., growers, processors, and affected workers), in the event the Florida citrus industry goes into a sustained decline, there is, in reality, a much broader affected constituency. Beyond dollar terms, citrus products are a healthful and tasty component of our diet, and citrus represents a cherished way of life for many growers and a key part of the state’s wholesomeness image for consumers, tourists, and prospective residents. Part of Florida’s “brand” and reputation is tied to citrus, which is a distinguishing feature for the state. While brands can be repositioned, it takes a long time and must be done carefully. Thoughtful scenario and contingency planning among stakeholders, including the aforementioned groups, developers, and those at the urban/rural interface, will serve to make painful transitions more orderly in the event that sufficient HLB countermeasure do not materialize. A substantial reduction in Florida citrus production has national economic implications. Eighty-five percent of the world’s orange juice production occurs in São Paulo State, Brazil, and Florida. Reduced Florida production presumably would result in increased imports, especially from Brazil and China. Similar considerations apply to Florida’s fresh citrus crops. As described in Chapter 2, citrus production in Florida has been under pressure from freezes, storms, diseases, decreasing water supplies, increasing costs of production, and urbanization. The number of juice processors has also declined. Experts suggest HLB is the most formidable challenge confronting commercial citrus in Florida and in many other citrus regions in the world as well. Unlike the instantaneously devastating, but somewhat localized, effects of hurricanes and freezes, unchecked HLB is expected to have a progressive impact on the commercial viability of Florida citrus. Some have

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140 STRATEGIC PLANNING FOR THE FLORIDA CITRUS INDUSTRY suggested that HLB could be the tipping point that irreparably cripples the Florida industry if HLB countermeasures prove to be insufficiently effective, are too expensive to employ, or do not come into practice soon enough. The purpose of the narrative that follows is to explore possible back-up plans and strategies should the Florida citrus industry we know today prove to be unsustainable under pressure from HLB. Tree loss and production yield decline are expected to be gradual, the actual rates being dependent on the aggressiveness with which current HLB management methods are applied. A key presumption is that, in the absence of newly developed and more effective management tools, Florida citrus will not disappear but will shrink to a fraction of its present size. Growers and orange juice producers will need to develop alternative business models that reflect this decline and still keep a critical mass of production facilities open. We are not able to recommend a specific grower/producer model for the future but only to identify some elements that may be a part of that future. The decline in the number of orange juice producers in Florida is expected to continue as fruit tonnage declines are exacerbated by HLB. Various HLB mitigation measure will be adopted and should contribute to reducing tree loss. However, groves will probably become concentrated in a few areas in which inoculum sources can be minimized and one or more processing plants can be sufficiently supplied. Forward- looking land management strategies will be crucial as growers seek to extend productivity of existing groves and perhaps plant new groves in areas less challenged by nearby sources of inoculum. Presumably, high density plantings with their necessary modified irrigation systems (Chapter 3) will be a part of the picture. The short time to production for high density plantings could keep the grove ahead of HLB and could save some processing plants from shutting down. Growers will need to partner with local and state lawmakers to devise plans, appropriate incentives and, quite possibly, ordinances that deal with issues such as abandoned groves and to minimize new abandonments without dealing appropriately with existing trees when individual growers elect to exit commercial production. In addition, land use plans and strategies that permit an orderly transition to economically feasible alternative uses should be considered as part of a long range master development plan that comports to each community’s vision of its future. Marketing campaigns for Florida orange juice will need to confront the greater importation of non-domestic product. This will require a delicate and planned balance of messages. On the one hand, the virtues of drinking orange juice irrespective of source must be conveyed to the public. On the other hand, the advantages of 100 percent Florida-sourced juice will need to be articulated clearly. At some point there is likely to be a pronounced price differential between imported and domestic juice due to the expected higher cost of US production as additional HLB management methods come into play. How will this be explained and domestic product positioned to US consumers? The issue of US and non-US juice blends will also need to be attended to in a way that does not confuse or alienate consumers as they make supermarket choices of which juice or drink they purchase.

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STRATEGIES FOR IMPLEMENTING PLANS FOR MITIGATION OF HUANGLONGBING 141 RECOMMENDED MEASURES FOR THE CONTROL OF NON-HUANGLONGBING DISEASES AND PEST PROBLEMS HLB is by far the most serious disease affecting the Florida citrus industry and should be given priority. Nevertheless, the other diseases and pests that currently occur in the state, or that occur elsewhere in the world and threaten the industry, should not be ignored. Citrus canker and HLB are both diseases that have been introduced in recent years and are currently affecting the industry, but other diseases occur elsewhere that could be potentially damaging to Florida citrus. Diseases such as citrus variegated chlorosis (Hartung et al., 1994), leprosis (Bastianel et al., 2006), Pseudocercospora fruit and leaf spot (Seif and Hillocks, 1998), and black spot (Peres and Timmer, 2003) could be serious problems for the industry if introduced (Appendix E). Most diseases and pests of citrus have been introduced into new areas by unauthorized, purposeful importation of budwood and other propagating materials or accidental movement on plant material brought in by tourists and other visitors. Except in specific cases, seed does not represent an important means of movement of citrus diseases. Likewise, commercially packed fruit is not a major means for movement of diseases, but can be for Mediterranean fruit fly, whose larvae actually live within the fruit (Thomas et al., 2007). Since vectors of leprosis, tristeza virus, and citrus variegated chlorosis are already present in Florida, there is less concern about the introduction of such insect pests. The efforts of regulatory agencies to intercept and prevent movement of pathogens should be increased and supported by the industry. The primary means to eliminate spread of systemic diseases is by the use of disease-free budwood and good nursery practices. The current system of production of propagating material has been effective in reducing the dissemination of many plant pathogens and pests. This program should be supported and expanded to prevent movement of any newly introduced pathogens or pests. Citrus canker has become widespread in the state and is an important problem for the industry especially for fresh fruit production. The primary controls for this disease are the use of windbreaks and application of copper products (Dewdney and Graham, 2009; Rogers et al., 2010). Windbreaks are highly effective for canker control but have not been widely planted in the state. The planting of windbreaks for citrus canker control, especially in fresh fruit growing areas should be encouraged. Many important diseases caused by fungi, such as postbloom fruit drop and Alternaria brown spot already occur in the state, but others such as Pseudocercospora fruit and leaf spot, black spot, and sweet orange scab that occur elsewhere still threaten the industry. Most of the diseases caused by fungi, whether they already occur in the state or could be introduced are controlled by application of fungicides or, in few cases, by utilization of resistant cultivars (Timmer and Brown, 2000). More effective fungicides for control of these diseases and other control measures need to be developed. Predictive models, such as PFD-FAD for postbloom fruit drop (Peres et al., 2005) and the Alter-Rater for Alternaria brown spot (Timmer et al., 2000), help reduce fungicide applications and improve disease control. Development of such systems for other diseases would be beneficial. Currently, there are few commercial cultivars available for control of fungal diseases. Efforts to develop such cultivars should be expanded and supported.

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142 STRATEGIC PLANNING FOR THE FLORIDA CITRUS INDUSTRY METRICS FOR PROGRESS Expand the Intellectual Base Addressing HLB A critical need is to expeditiously expand the research base that is looking for solutions to HLB. Increasing intellectual capacity that mitigates HLB requires striking international and multidisciplinary scientific collaborations. Competitive research funding will attract new researchers and new ideas, potentially from divergent fields, that have the potential to make rapid progress. Rigorous evaluations, from scientific and industry perspectives, of research priorities, proposals, and progress are critical to ensure timely advancement in the field. An important metric will be the number and caliber of scientists entering the HLB field and progress of scientific advancements against HLB disease. Encourage Global Cooperation Mitigating HLB will require global cooperation in intellectual development, research funds, and biological resources. Particularly in the area of genetics and breeding, the capacity to evaluate and maintain large and diverse germplasm blocks is critical. This can be facilitated by access to counter-seasonal climate and to shared fields. A collaborative network of citrus geneticists and breeders coordinated from a single site can provide more strategic use of resources, reduce redundancy and accelerate progress in genetic improvement. The development of global collaborations and the leveraging of external research resources towards common objectives should be a measure of progress. Translational Research A research program that is targeted towards practical outcomes should embrace a philosophy of translational research from its inception. In concrete terms, translational research programs are characterized by investment in fundamental research that is required to understand the problem at hand but with close linkage to applied research programs that can rapidly translate the results to the field. This requires interdisciplinary research teams and the development of a research community that communicates frequently and easily. A culture for information sharing, publication, and scientific workshops and meeting should accelerate research and development. In addition, if the program is sponsoring transgenic research it should explicitly integrate an assessment of the “downstream” IP and regulatory issues at the outset of each project and invest in the expertise and strategies that will facilitate the deployment of successful research targets. A measure of progress should include early progress in adopting a translational research philosophy and in establishing processes of information sharing and accountability in terms of timelines and progress towards research deliverables.