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NRSP_TEMP201: The Specialty Crop Regulatory Assistance Program

Statement of Issues and Justification

Prerequisite Criteria: Mission

The State Agricultural Experiment Stations and the 1890 Land Grant Universities and Tuskegee have invested significant public resources for research on transgenic crops, with the expectation that benefits would accrue to the public. The investments were made to support ESCOP/ESS priorities, but most of the anticipated benefits have not been realized. For example, in the 15-year period between 1990 and 2005, the USDA Cooperative State Research, Education, and Extension Service (CSREES) provided an estimated $5,000,000 per annum to support public sector research on genetically-engineered crops through competitive programs, special grants, and Hatch funds. Hatch funds require a 100% state match, so for example, in FY2005, states provided a match of at least $820,000. Altogether, USDA has invested approximately $200,000,000 in state and federal research on transgenic crop research from 2002-2007. The return on this investment in transgenic crop research is vanishingly small. One of the few examples developed through public research is the virus-resistant papaya that has made it to the market place, where it has been a success.

Consistent with the mission of National Research Support Projects (NRSP), the Specialty Crop Regulatory Assistance (SCRA) initiative activities will help transgenic crop research reach its full potential by addressing specific obstacles that confront small market crops (specialty crops), including fruits, vegetables, tree fruit and nuts, ornamentals and nursery crops, and emerging crops (such as industrial and bioenergy crops).

Crops developed using transgenic methods are not available for farmer and consumer choice until they are deregulated by federal agencies. Intended benefits for production, environmental stewardship, and human health are not realized until deregulation and commercialization are achieved. The consensus from two open stakeholder workshops in 2004 and 2005 (e.g., Goldner et al., 2005) and from other reports indicate that uncertainty, duration, cost, and lack of familiarity with the regulatory process are among the reasons why research on many transgenic applications remains underutilized or not initiated (e.g., Dobres, 2008). These factors are particularly limiting for specialty crops and for research by public sector and small-scale private sector crop and technology developers.

SCRA will support a spectrum of activities that assist public and private sector developers in navigating through the regulatory process in an efficient manner for a range of crops and traits. NRSP funding will provide an essential foundation of support for the administration and coordination of the program as well as some funding focused on assisting with the regulatory challenges of a few selected projects. This foundational funding will provide staffing support and flexibility and critical leverage to allow SCRA to secure funding from other sources, such as USDA and the private sector, to amplify its work and broaden its assistance activities. Consistent with NRSP guidelines and objectives, the SCRA will not fund or conduct research to develop new transgenic crops or traits per se, but may support research that answers specific regulatory questions as needed by a particular application.

see attachment for Table 1:

Table 1. Creation of public value by SCRA. Headings adapted from Kalambokidis and Bipes, 2007, Regents, U. of MN

Prerequisite Criteria: How does this NRSP pertain as a national issue?

The primary national issue to which SCRA is relevant is the loss of anticipated benefits from public research on transgenic crops. As stated above, the lack of return on investment for public research support for transgenic crops is glaring. All ESCOP regions including ARD, have conducted and are conducting research on transgenic crops, and/or other, fundamental, research that will rely on transgenic crops to deliver benefits. However, relatively few of these benefits have become available commercially, particularly in specialty crops. While there are a number of factors contributing to this issue, a major hurdle is the complexity and cost of achieving regulatory approval for public release of transgenic plants (e.g. editorials, Nature Biotechnology and Scientific American, 2004; Bradford and Alston, 2004). Regulatory issues include costs of conducting required testing; a certain inevitable level of unpredictability of requirements, particularly with new crops and traits; and lack of familiarity among researchers, administrators, investors, and other decision makers about requirements, duration, and potential outcome of the regulatory process. SCRA will assist directly with these issues. As a facilitator, SCRA will be able to assist crop developers reduce the time that is required to prepare the components of a deregulation dossier for a given regulatory agency. By interacting with crop developers early in the crop development process, SCRA will often be able to provide guidance for the development of required regulatory data to streamline the process and reduce cost. SCRA may also provide cost savings to some public and many small private sector transgenic crop developers by providing guidance and regulatory compliance infrastructure that these institutions may not be able to support year to year.

SCRA will help indirectly albeit importantly in enhancing consumer confidence that the regulatory system is protecting their safety. By enabling the commercialization of safe crops with tangible benefits for consumers and the environment, SCRA can help influence public opinion about the value of modern methods of crop improvement. Providing the public first-hand experience with diverse biotech-derived crops and traits, whether directly consumed, enjoyed (i.e., ornamentals), or as used in other ways, will demonstrate their value and safety. SCRA can ensure that consumers and producers have the opportunity to make better choices for improved nutrition, lower food costs, increased productivity, global competitiveness, and reduced environmental impacts.

The marketing of biotech crops by small companies and public breeders has been limited in some cases precisely because of the costs and uncertainty of the regulatory process. Innovative public action by SCRA will broaden participation and help to alleviate concerns that the benefits of the technology accrue only to large companies. To achieve broader participation (Table 1) in transgenic crop prioritization, development, and commercialization, SCRA will:

(a) Support entry into the regulatory process for a wider range of crops, traits, and developers; and

(b) Create additional opportunities for regulators to gain experience with reviewing additional crops and traits, making subsequent reviews of similar crops more efficient for all involved. SCRA support will help meet one of several steps necessary (i.e., regulatory review for safety), for increasing the diversity of crops, traits, and sources that are available and visible to the public. In this way, the availability of diverse crops and traits will provide consumers with first-hand opportunities to purchase and try foods and other plant products from these crops and form opinions based on actual experience. Further, it will provide farmers and ranchers with additional choices to help them remain competitive and reduce input costs and increase output traits that, perhaps, can provide added income derived from niche or specialty markets.

Rationale: Priority Established by ESCOP/ESS

SCRA will support ESCOP/ESS priorities (Table 2) by facilitating a critical step in the development and commercialization of transgenic crops developed from research by land-grant universities, agricultural experiment stations, and others. Transgenic crops research in ESCOP institutions address five of the seven ESCOP priorities: food security and health (#1), environmental stewardship (#2), economic returns to producers (#3), new production practices (#5), and lessening climate risk (#6) (Table 3). The potential impact of SCRA on increasing the global competitiveness of U. S. farmers has been an interest of the USDAs Foreign Agricultural Service (FAS), which joined other USDA agencies in sending a liaison to both workshops and the planning group meetings.

See attachment for Tables:

Table 2. ESCOP/ESS Priorities. From: Science Roadmap for Agriculture Priorities. NASULGC, ESCOP, 2006. Priorities in bold are addressed by SCRA.

Table 3. Some examples of transgenic small-market /specialty crops research at AES and ARD entities. A larger table (9 pages) is included as App. 1.

Some ESCOP stakeholders believe that other approaches, such as organic agriculture, are a better way to address ESCOP priorities. Present information, however, suggests that both of these systems, i.e., systems that employ transgenic crops, and, organic systems, can and do contribute to ESCOP goals (Barfoot and Brookes, 2007; Field to Market: Keystone Alliance for Sustainable Agriculture, 2009). Agriculture of the future, characterized by a diversity of farming systems and products, should be able to employ a variety of methods to address multiple markets, preferences, and needs. This can create multiple economic streams of production, employment, and income. It is appropriate for the public sector to explore and provide options for stakeholders to benefit from diverse agricultural systems. ESCOP can help ensure that promising opportunities will be available to develop transgenic crops that will:

" Enhance nutrition

" Reduce the environmental footprint of agriculture

" Lower production costs

" Develop new products

" Adapt to changing climate

Rationale: Relevance to stakeholders

A significant criterion for SCRA assistance, in the pilot Project Evaluation Process (PEP) (App. 4), is potential impact for stakeholders. SCRAs primary stakeholders include public and private crop developers, farmers and growers (e.g., through commodity groups), and processors. Secondary stakeholders include the public as consumers and as environmentalists. Primary stakeholder representatives have participated in SCRA planning workshops; serve on the transitional Board of Directors (Table 4); and will be represented on SCRAs Board of Directors and Stakeholder Liaison Group. Secondary stakeholders will be included in the SCRA Board of Directors through the Stakeholder Liaison Group, whose chair will be a member of the SCRA Board of Directors, and participate in SCRA extension and outreach activities. The Stakeholder Liaison Group will include a diverse range of primary and secondary stakeholders from all interested groups.

See attachment for Table:

Table 4. Stakeholder participation in the SCRA Transition Board.

SCRA will meet primary stakeholder needs by assisting public and private sector developers through the regulatory process for a range of crops and traits. This will allow these stakeholders to move towards commercialization, creating the opportunity to realize intended outcomes from research investment. Farmer/grower stakeholders will have a broader choice of varieties to help protect farm worker health, manage their land for environmental stewardship, earn greater economic returns, compete in global markets, and cope with climate risk.

SCRA will meet secondary stakeholder needs by providing additional choices to consumers and by conducting general outreach (including in partnership with on-going efforts; see section on Integration with Extension and Outreach) to disseminate knowledge of the new crops and traits, the diversity of sources (crop developers), and the regulatory requirements and procedures used to evaluate their safety. In the long term, SCRA will contribute to secondary stakeholder needs through contributions of transgenic crops for food security, human nutrition and health, and new sources of economic growth and jobs.

The long-term critical measure of SCRA success will be deregulation or regulatory approval of products that receive SCRA support or assistance. The initial 5-year period from 2009 2014 may be too short to achieve more than one or two deregulated products. Measures of success during this period will include participation in stakeholder workshops or education/training sessions, extent of web services used, and number of proposals for which regulatory dossiers are under development, developed, or submitted.

The relevance of SCRA to stakeholders is reflected in statements such as these:

As a potato grower I understand the potential of new potato varieties developed through biotechnology to improve the quality, nutrition and productivity of potatoes. The benefits of this new technology have the potential to directly benefit consumers who want to continue to obtain potatoes and potato products that are safe, nutritious, enjoyable and affordable. Consumers confidence in any new technology is dependent on effective review and oversight by the federal government. I am encouraged that there is consideration for placing a program in place that will assist companies and institutions in completing that regulatory process. - Donald Sklarczyk, Sklarczyk Seed Potato Farm; Research Committee, National Potato Council, Jan., 2009.

Our companys target product list certainly fits within the Specialty Crop arena, and we have invested heavily to bring biotechnology-enhanced products to the market place. In addition to our turfgrass products, we have a strong interest in flowering ornamentals, in particular bedding plants such as petunia and geranium. We have essentially put our ornamentals program on hold due to the cost and time of regulatory review. A program that would allow a more direct, predictable and cost effective path to market clearance would be a great benefit to our market, our company and ultimately our consumers and the environment.-- Bob Harriman, The Scotts Company, Jan. 2009.

I enjoyed speaking with you last week regarding the Specialty Crop Regulatory [Assistance] Initiative. This is precisely the type of initiative that the vegetable and fruit industries will need in the future for transgenic varieties to make their way into the marketplace. We are very supportive ct your efforts to get an organization started that includes both the public and private sectors in order to pave the way for regulatory clearance of transgenic specialty crops. - California Lettuce Research Board, letter to Alan McHughen, SCRA planning group chairman, March 24, 2006.

The SCRA is critical to the citrus industry as a means of easing the pathway to commercialization of transformed trees. At the present time, genetic solutions to Citrus Greening --solutions that may be achieved through biotechnology--are the only hope to keep the US citrus industry viable. Citrus Greening (or Hwanglongbing HLB) is the greatest threat to all forms of citrus trees, both for urban homeowners and commercial enterprises. --T. Batkin, Citrus Research Board, Jan. 2009.

Public policy relevance: SCRA project outcomes will contribute to discussion and development of public policy in the U.S.. SCRA support for crop developers, crops, and traits that might otherwise not enter the regulatory process, will create additional opportunities for regulators and the public at large to gain experience with additional crops and traits. The biotechnology regulatory process evolves based on experience. While SCRA will work with the existing regulatory process at any given time, and it is not an intent of SCRA to suggest changes to the process, the additional experience made possible by SCRA may reveal to regulatory agencies potential changes they may consider during their own internal planning.

General Approach: The SCRA Mission is to facilitate regulatory clearance through the existing regulatory regime for transgenic (biotechnology-derived) specialty crops developed by the public and private sector. SCRA is a collaborative public-private effort to establish a program for assisting public and private sector developers of biotechnology-derived specialty crops leading to the deregulation of a broader selection of specialty crops. Regulatory costs and complexities can impede and obstruct the availability of diverse crops with biotechnology-derived traits even for those crop developers having resources to address the regulatory process (Alston et al, 2006). SCRA is in a unique position to work with crop developers developing crops with value-added (output) traits. It will learn from and compliment the work of NRSP-4 that has recently begun working with transgenic crops with new crop protection (input) traits, e.g., plum pox-resistant plums. Output traits support is outside of the mandate of the NRSP-4.

SCRA will be modeled after successful public programs, such as FDAs Orphan Drug Program and Critical Path Institute, and NRSP-4 (IR-4). SCRA will work within the existing US regulatory framework to facilitate the interactions between crop developers and regulatory agencies. Similar to the FDAs Critical Path Institute, SCRA will serve as a knowledgeable third party, providing regulators, research entities, growers, and consumers an opportunity to work together toward more choices for farmers and consumers. SCRA will provide (a) a delineation of regulatory requirements for a specific biotech crop, as developed with appropriate regulatory agencies; (b) assistance in compiling regulatory application dossiers, including funding for data necessary to meet regulatory requirements; and (c) guidance in navigating through the regulatory process.

Current Status:

SCRA has received seed funding from USDAs Office of the Secretary ($134,000 from 2004 to 2009) for developing a business plan, outlining an organizational structure, and developing a roadmap for phased implementation of the SCRA programs and services. The USDA support provided impetus and credibility to the first phase of SCRA. There is a need to expand the development of the SCRA to ensure that all interested parties are able to participate. SCRA is operating currently with a transitional board of directors, executive committee, and executive director. The NRSP program would provide a timely opportunity to establish a firm foundation for SCRAs structure, operating framework, and initial deliverables/public services (e.g., this may include information about existing guidance documents, public domain data that can be used in regulatory dossiers, information on where to find help, etc.). The structure and responsibilities of the board, its committees, and the Stakeholder Liaison Group have been developed (see App. 2) but not fully implemented, as funding has not been available. NRSP funding would allow the SCRA to establish the first board and launch the Stakeholder Liaison Group. A publicly-funded SCRA core would give confidence also to the private sector to go beyond the advisory support they have provided to date by contributing financial support to SCRA.