NRSP004: Enabling Pesticide Registrations for Specialty Crops and Minor Uses
Statement of Issues and Justification
Prerequisite Criteria: MissionNRSP-4's (the activities of NRSP-4 are known throughout the land grant university and agriculture communities as IR-4. NRSP-4 and IR-4 are used interchangeably in this document) main role is to facilitate research activities throughout the United States to support registration of safe and effective chemical and biological pesticides regulated by US Environmental Protection Agency (EPA) for specialty crops and other low volume, minor uses. The NRSP funding supports the administration and coordination of the program, but it does not support the extensive research activities directly at the numerous research farms and laboratories at state agricultural experiment stations (SAES) or USDA-Agriculture Research Service (ARS) facilities.
The NRSP-4 funding has been historically assigned by the IR-4 Administrative Advisors and the IR-4 Project Management Committee to IR-4 Headquarters to offset this unit's personnel costs. It currently accounts for a significant amount (> 80%) of IR-4 Headquarters Management Team's (Executive Director, Associate Director, and Assistant Directors) salaries The NRSP-4 funding is very significant for the operations of IR-4 Headquarters which has a critical role in the overall coordination and management of the national IR-4 Project. This support is also important as an indication of the continuing commitment from the land grant university system and the Directors of the SAES to this unique and very effective partnership with the federal government, the states, the crop protection industry and growers of specialty crops that impacts every state, region and US territory.
The overwhelming majority of research activities are funded by other public and private sector sources. IR-4 leadership, in cooperation with support from stakeholders, has been very successful in leveraging the NRSP funds with funds from other sources, including resources through National Institute of Food and Agriculture (NIFA -formally known as USDA Cooperative Research Education and Extension Service or CSREES), ARS, USDA-Foreign Agriculture Service (FAS) and from the crop protection industry and commodity organizations. In 2009 the $481,152 provided through NRSP was leveraged and assisted in NRSP-4 receiving nearly $17.5 million dollars of direct funds from USDA and other sources NRSP-4 continues to perform a critical role in facilitating the registration and label expansion of pest control products for high value specialty uses on food and ornamental crops at a time of rapid change, including the worldwide consolidation and refocusing of the crop protection industry, limited profitability for growers, strong foreign competition, and uncertainty due to regulatory action against many standard pest management tools. The future viability of high value specialty crop production throughout the US is highly dependent on continuing substantial support for NRSP-4 to provide growers with the pest management products to safely manage the pests that deleteriously effect productivity and economic value of agricultural crops.
Prerequisite Criteria: How does this NRSP pertain as a national issue?NRSP-4 under the predecessor name of Interregional Research Project Number Four (IR-4) was established in 1963 by the Directors of the SAES because of the "Minor Use Problem". The Minor Use Problem is universal throughout the US; the cost of data development to support a chemical or biological pesticide registration for a specialty crop or minor use of a pesticide is expensive and the potential return on investment from sales of a pesticide on low acreage specialty crops or minor uses is very small. There is very limited economic justification for the chemical or biological pesticide companies to invest their resources in supporting registrations in these markets of limited profitability.
Having adequate pesticide products to manage pests in specialty crops is critically important. Specialty crops are fruits, vegetables, herbs and nuts that nutritionists recommend as being essential for a balanced and healthy diet or the ornamental crops which enrich our environment. There are well over 600 food and feed crops in the US that can be classified as specialty. All ornamental crops are "minor". The total value of these crops in the U.S. is approximately $49.6 billion, which represents 34 percent of the total value of all crops (2007 Census of Agriculture). The economic importance of these crops varies widely among the states. In ten states (AZ, CA, FL, MI, NC, NY, OR, PA, TX & WA) sales of specialty crops exceed one billion dollars annually. In the Northeast region, the sales of specialty crops are greater than 50% of the total crop sales in all states and exceed 75% in most. Damage to these specialty crops can have devastating impacts on local and regional economies.
The Minor Use Problem extends beyond high value specialty crops to major large acreage crops such as corn, soybeans, cotton, wheat and others that are grown broadly in numerous states. On major crops, the minor uses need is to manage a pest that is localized, infrequent or sporadic. The low or irregular sales to manage these minor pests result in very limited private sector investment.
Pesticides to manage mosquitoes, ticks and other arthropod pests that transmit disease and pose a threat to public health are also considered minor uses. NRSP-4 has recently expanded its mission and entered into a cooperative project with ARS and the Department of Defense's Armed Forces Pest Management Board to facilitate registration of the newest generation of reduced risk pesticides to control medically important arthropods.
The management of arthropods of medical importance is a priority objective of the US government as well as numerous non-governmental organizations. The need for an organization like IR-4 to provide regulatory support for minor uses of pesticides for public health uses was articulated in the Minor Use Title of the 1996 Food Quality Protection Act. Given the IR-4 Project's expertise in data development supporting pesticide registrations, USDA-ARS requested assistance to provide those involved in public health pest management with the newest generation of lower/reduced risk pesticides while effectively controlling pests that transmit human health diseases.
NRSP-4 has considerable expertise and almost 50 years of experience in developing the necessary data to ensure specialty crop growers and users of minor use pesticides throughout the United States have legal access to the chemical and biological pesticides that must be registered by EPA before they can be used. NRSP-4 has been successful, facilitating nearly 12,000 registrations for food crops and 11,000 registrations for ornamental crops. Because pesticide registrations are often national in scope, growers in all states often benefit from the efforts of IR-4.
In spite of the significant progress in facilitating critical registrations for specialty crops and other minor uses, the need for NRSP-4 is even greater today. EPA, under the authority of the Food Quality Protection Act (FQPA) continues to reassess the ability of specific pesticides to meet current safety standards. Significant losses of important uses of older compounds have and will continue to occur for a variety of reasons including cumulative risk, aggregate risk, potential for endocrine disruption, and effects on endangered species or their habitat. EPA has given priority for the registration of Reduced-Risk chemicals to replace the chemicals of concern. These Reduced-Risk chemicals have been the major focus of the NRSP-4 effort since 1995 and are intended to be the thrust of NRSP-4 research efforts now and in the future.
Pest resistance to pesticides continues to be an important issue. Numerous pesticides are no longer controlling their target pest due to evolution of the pest to avoid the toxic effects of the pesticide.
Because of modern safety standards, the associated limitation of use of older products, and the loss of effectiveness due to pest resistance to pesticides, new reduced risk pesticide products are needed to provide options for growers. And just like before, the industry focuses their development efforts on products for major markets. Thus the need for a substantial NRSP-4 effort is predicted to continue for at least the next decade.
In order to accomplish its mission, the NRSP-4 Project engages specialty crop pest management scientists within SAES, USDA and commodity organizations. In every state, NRSP-4 has at least one scientist associated with the SAES to articulate needs and priorities from that respective state as the official IR-4 State Liaison Representative (SLR). Many SAES Directors, to provide better service to their stakeholders, have assigned two SLR's, one for food crops and one to service the ornamental industry.
Many additional scientists are actively engaged with NRSP-4 by articulating needs setting priorities, and conducting research or providing tactical or strategic direction. Over 275 scientists and stakeholders from SAES, extension and industry attend the IR-4 Food Crop and Ornamental Workshops. Some of these same scientists are also involved in conducting NRSP-4 research at the SAES or ARS sites. IR-4 receives about 80 new biopesticide proposals annually from the prominent scientists involved in the development of biopesticides. Many other scientists are involved with NRSP-4 on an as needed basis.
Rationale: Priority Established by ESCOP/ESS1. Relation to ESCOP/ESS National Priorities NRSP-4 addresses and supports four of the seven ESCOP Roadmap Challenges. The primary contribution of NRSP-4 is ESCOP Roadmap Challenge 5 - improve competitiveness and profitability/economic return to the producer in agriculture.
Arthropods, plant diseases, weeds and other pests of crop plants continue to reduce both the quality and quantity of domestically produced food and non-food crops. It has been suggested by many that one-third of everything grown is still lost to pest damage. The amount lost in food and revenue would be much higher without the availability of modern pest management technology.
The activities and deliverables of NRSP-4 are critical to the cost of production for high value specialty crop production systems in the US. IR-4 has been extremely successful in facilitating registrations on specialty food and ornamental crops. This is especially true in the last five years when IR-4 has developed data and supported 4,761 new registrations on food crops. Typically, IR-4 developed data supports approximately 50% of the new tolerances established by EPA in a given year. The food crop deliverables achieved in the past five years represent approximately 40% (12,056) of the total IR-4 tolerances established since 1963. Additionally, NRSP-4 data supported 35 registrations impacting over 7,900 ornamental crops in the 2006-2008 period.
The impact of the above efforts on American agriculture can be judged from the fact that, without IR-4, many of the important high value specialty crops in the US would have few, if any, crop protection compounds available for pest management. Not only has IR-4 continued to provide critical tools for growers, but it has also reduced chemical use and grower costs in many cases. Further, in the last 10 years, IR-4 has focused its efforts very strongly on providing safer, reduced-risk chemicals to replace older compounds with undesirable toxicity and environmental impact. Although this contribution to the safety of applicators, consumers, and the environment is hard to measure, it is nevertheless real and growing.
NRSP-4 also contributes to Challenge 4 - improve environmental stewardship. The focus of NRSP-4 on registering reduced risk chemicals and biopesticides for pest management will increasingly improve the safety of agricultural production systems to the environment and pesticide applicators, and will enhance food safety. In a recently published Ph.D dissertation by Faye Regina Aquino Viray of Michigan State University, the author noted, "The use and food residues of individual organophosphate insecticides showed a strong declining trend with an approximately 50% decline overall for the group. The use of carbamate insecticides also declined approximately 70% from 1996 to 2006, but their residue trends were variable and did not clearly correspond to the decline in use. Use of the B2 fungicides declined less (10-20%) and there was no overall decrease in residues for most of these compounds. There was a steady increase in use of reduced-risk (RR) insecticides and fungicides over this time such that they are now central in pest management programs for fruits and vegetables, but the residue data are too limited to establish a trend. In some cases, residue detections were unexpectedly high and greater than those for the older compounds. It was estimated that approximately 50% (33-60%) of the RR pesticides for these food uses were registered by USDA's IR-4 program. Since the RR pesticides are applied at much lower rates than the older compounds, their adoption has resulted in lower levels of chemical use in fruit and vegetable production".
NRSP-4 contributes to at least two other priority areas which include: 1) Develop new and more competitive crops and products (Challenge 1). Without NRSP-4, the introduction of many new crops would not be possible, since they are generally high value specialty crops with few, if any, pest control tools. NRSP-4 has been very successful in integrating new crops into existing crop groups that provide these fledging crops with an instant toolbox of pest management products to protect the crop. For example, NRSP-4 facilitated the addition of gogi berry into the Fruiting Vegetable crop group allowing this newly introduced crop, which has tremendous potential health benefits, access to many of the crop protection products that are registered for tomato and pepper. 2) Enhance food safety and human health (Challenge 7). NRSP-4's participation in efforts to control medically important arthropods is key to preventing outbreaks of vector-transmitted diseases that pose a risk to public health. In this area, NRSP-4 is attempting to facilitate the registration of the newest generation of reduced risk products and biopesticides to manage mosquitoes, ticks and other pests that can transmit human disease.
Rationale: Relevance to stakeholdersThe primary stakeholders of the research activities of NRSP-4 are the domestic growers of specialty crops and food processors. These primary stakeholders have significant involvement with the operations of NRSP-4. First, all NRSP-4 sponsored research is stakeholder driven. Research is prioritized at the IR-4 sponsored Food and Ornamental Workshops by growers, commodity organizations, and university research and extension specialists who specifically represent grower needs. On an annual basis, approximately 175 stakeholders will attend the IR-4 Food Use Workshop. Every other year, about 100 stakeholders attend the Ornamental Horticulture workshop. NRSP-4 research activity is a direct reflection of the priorities set at these workshops by the primary stakeholders.
Additionally, NRSP-4 has an IR-4 Commodity Liaison Committee (CLC) consisting of growers, representatives of commodity groups and food processors. This 25 member committee meets two times a year to provide NRSP-4 management guidance on procedures and policy. The Chair of the CLC is a full voting member of the IR-4 Project Management Committee. CLC members serve as specific resource throughout the year on an ad hoc basis.
Besides domestic growers of specially crops and food processers, there are several other stakeholder groups/partners that are actively engaged with NRSP-4. These include: a) The Crop Protection Industry provides NRSP-4 access to biological and chemical crop protection products that NRSP-4 uses in their research to solve primary stakeholder problems. NRSP-4 meets with most companies at least once a year and has multiple meetings with larger companies. At these meetings, cooperative strategies and timelines are developed. b) State Agricultural Experiment Stations provides the Multi-State Research Funds and host the NRSP-4 field /laboratory research sites and offices. It is estimated that the SAES provides on an annual basis $12.0 million of in-kind support. The Directors of the SAES interact and provide direct input into NRSP-4 through the four Regional Administrative Advisors who attend all IR-4 Project Management Committee meetings. c) USDA-National Institute of Food and Agriculture (NIFA) provides $12.18 million of direct funding for NRSP-4, which is the largest single source of direct funds for NRSP-4. Funding is provided to NRSP-4 units at the SAES to develop the required data to register the high priority pest control products on specialty crops and minor uses. A representative of NIFA attends and participates in the IR-4 Project Management Committee meetings. d) USDA-Agricultural Research Service works in full coordination with NRSP-4. This Service provides personnel and research funds for pest management research at three analytical laboratories and eight field research centers. An ARS Scientist and an ARS National Program Leader attend the IR-4 Project Management Committee meetings. The Scientist participates as a voting member of the IR-4 Project Management Committee and the National Program Leader participates as an Administrative Advisor. e) Agriculture and Agri-Food Canada (AAFC) Pest Management Centre conducts research of mutual interest to U.S. and Canadian specialty crop growers. These studies are conducted concurrently in both countries. AAFC provides 50-60 field trials each year in support of IR-4 studies. Results are combined and data packages (petitions) are submitted to both United States and Canadian regulatory agencies. Representatives from this group regularly attend NRSP-4 sponsored priority setting and management meetings. f) USDA-Foreign Agriculture Service (FAS) provides direct funding for the on-going global residue study being conducted on tomatoes in 27 countries. g)USDA Agricultural Research Service provides direct funding for IR-4 to assist ARS and the Deployed War Fighter Protection Program (DWFP) in data development and support in the registration process of new toxicants, repellents, and attractants to protect military personnel against insects that transmit disease.
All stakeholders continue to find the outputs, deliverables and impacts from NRSP-4 extremely beneficial. In 2007, NRSP-4 commissioned a study with Michigan State University, Center for Economic Analysis to ascertain the economic impact of IR-4 efforts in the Food Crop program. Dr. Steven Miller authored the report, National Economic Impact of the IR-4 Project , which concluded, "it is estimated that by providing a sufficient supply of pesticides for specialty crop growers, the IR-4 Project directly contributes $4.564 billion in output of specialty crops in the US based on 2006 estimates. The nature of such products across the US is likely to stimulate additional economic output through a well-documented multiplier effect. Considering this multiplier effect, the total expected contribution of the IR-4 Project to the US gross domestic product is $7.675 billion. Such contribution to gross state product is expected to support over 113 thousand US jobs with annual wages of nearly 5 billion dollars". The Center of Economic Analysis at Michigan State University also conducted an economic assessment of the IR-4 Ornamental Horticulture Program. They concluded, The IR-4 Ornamental Horticulture Program and its annual research investment of $1.2 million contributes $1.176 billion annually to the US gross domestic product, a return on investment of over 900 times. Additional impacts of IR-4's efforts on providing pest control tools for food crops have been measured. For the last 11 years, IR-4 has monitored the amount of loss avoidance of pesticide uses for which state(s) have included in Section 18 emergency exemptions submitted and approved by EPA. During this period, growers in states with approved Section 18s that were being supported by IR-4 data avoided a total of $17.8 billion or an average of $1.62 billion annually.
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