NRSP004: Enabling Pesticide Registrations for Specialty Crops and Minor Uses
Annual/Termination Reports (SAES-422): [12/18/2012] [12/18/2012]
Date of Annual Report: 12/18/2012
Report Information:
Participants:
- March 2010: http://ir4.rutgers.edu/PMC/PMCMAR10minutesfinal.pdf
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October 2010: http://ir4.rutgers.edu/PMC/OCT2010/PMCOCT10minutes.pdf
Brief Summary of Minutes of Annual Meeting:
March 2010: http://ir4.rutgers.edu/PMC/PMCMAR10minutesfinal.pdf
July 2010: http://ir4.rutgers.edu/PMC/Jul2010/PMCJUL10.pdf
October 2010: http://ir4.rutgers.edu/PMC/OCT2010/PMCOCT10minutes.pdf
Accomplishments:
Short-term Outcomes: The regulatory approval of safe and effective crop protection chemicals to assist in the production of food and ornamental crops continues to be the central objective of the IR-4 Project. IR-4 is committed to provide the support required to give growers the tools they need to be successful and competitive. In most cases IR-4 develops residue data on food crops and pesticide efficacy/crop safety on ornamental species to support new registrations for these specialty crops. However, the need for product performance data on food crops has increased over the past few years. This is mainly due to the companies requesting some efficacy and/or crop safety data prior to marketing a new use. IR-4 efforts to expand crop groups and use of extrapolation based on our residue studies have all contributed to the greater need for efficacy and crop safety data.
Outputs: This accountability document captures IR-4's numerous accomplishments, successes and deliverables for 2010 as well as presents on-going efforts to sustain IR-4's service to our stakeholders who are involved with managing pests of specialty crops and other minor uses. IR-4's 2010 accomplishments include:
In the Food Program, US Environmental Protection Agency (EPA) established 219 new permanent pesticide tolerances which supported 786 new uses. EPA also established the Oil Seed Crop Group and enhanced the Fruiting Vegetable, Citrus and Pome Fruit Crop groups. With biopesticides, IR-4's efforts facilitated 3 new registrations including acetic acid for weeds in organically grown food and ornamental crops, HoneySweet Plum, a USDA plant incorporated protectant technology for stone fruit, and almond and Trichoderma hamaum isolate 382 in all food and ornamental crops. Finally, IR-4 data has been used to support 4 new registrations and label amendments for ornamental horticulture crops, this positively impacted 2367 ornamental uses.
In an effort to assist the specialty crop growers by eliminating pesticide residues as a barrier of access to export markets, some IR-4 data was reformatted into 20 data packages and submitted to the Joint Meeting of Pesticide Residues (JMPR). This data supported 16 Codex Maximum Residue Levels (MRLs).
Activities: Activities in 2010 that will support future deliverables/registrations on food crops involves the initiation of 84 residue studies that consists of 604 field trials. The Canadian Pest Management Programme participated in 16 studies in 2010 by contributing 53 field trials. IR-4 also conducted over 50 Efficacy and/or Crop Safety trials conducted on food crops to answer the product performance data requirements for 24 projects. IR-4 Study Directors submitted 55 new residue tolerance petitions to EPA. This is down from 126 in 2009. This is partially attributed to backlogs within the analytical laboratories and delays within companies in providing IR-4 with required submission documents. Additionally, IR-4 submitted proposals to expand and enhance the edible and inedible peel tropical crop groups. Organized and specific functions or duties carried out by individuals or teams using scientific methods to reveal new knowledge and develop new understanding.
Additional activities in other areas include:
- We continue to work on the Global Residue Project, which examines if residue data from one geographic zone can be used to support the data needs of another zone. Full results from 21 of the 27 sites were achieved in 2010. Data from the other sites are expected in 2011.
- IR-4 awarded funds for testing the efficacy of biopesticides involving 5 early stage projects, 21 advance projects and 10 demonstration purposes. Additionally, IR-4 submitted 6 data packages to EPA/registrants for biopesticides.
- IR-4 conducted 1473 field trials on ornamental crops to collect efficacy and/or crop safety data within 912 studies. Additionally, IR-4 developed and submitted 21 data summaries to registrants to expand the use of pesticides on ornamentals
- IR-4 completed its first study; of residue data to support registration of ethofenprox to control adult mosquitoes near crops. This will be submitted to EPA in 2011
Impacts: The accomplishments of the IR-4 Project are many. The specific successes, accomplishments and deliverables for the Food Use Program, Ornamental Horticulture Program, the Biopesticide and Organic Support Program and the Public Health Program of the IR-4 Project are documented in the IR-4 Annual Report (http://ir4.rutgers.edu/Other/AnnualReports/2010%20IR-4%20Annual%20Report.pdf).
Without the existence of the IR-4 Project, few safe and effective crop protection chemicals and biological alternatives would be available for use on food and ornamental specialty crops and minor uses. Specialty crop growers often report on the impact of the IR-4 Project to their business. Some have said, Without the IR-4 Project and what they provide, my farm would be out of business . In an effort to capture a solid assessment of program value, in 2010, Michigan State Universitys Center of Economic Analysis conducted an economic impact study of IR-4s food use activities, ornamental horticulture and biopesticide programs. Their assessment indicated that the efforts of the IR-4 Project add $7 billion dollars annually to the gross domestic product (GDP).
Impact Statements:
Date of Annual Report: 12/18/2012
Report Information:
Participants:
- March 2011: http://ir4.rutgers.edu/PMC/March2011/PMCMAR11.pdf
-
July 2011: http://ir4.rutgers.edu/PMC/2011FallPMCMaterials/PMCJuly2011draftMinutes.pdf
-
October 2011: http://ir4.rutgers.edu/PMC/2011FallPMCMaterials/PMCOct2011Minutes4Jan2012%20(3).pdf
Brief Summary of Minutes of Annual Meeting:
March 2011: http://ir4.rutgers.edu/PMC/March2011/PMCMAR11.pdfJuly 2011: http://ir4.rutgers.edu/PMC/2011FallPMCMaterials/PMCJuly2011draftMinutes.pdf
October 2011: http://ir4.rutgers.edu/PMC/2011FallPMCMaterials/PMCOct2011Minutes4Jan2012%20(3).pdf
Accomplishments:
Short-term Outcomes: The regulatory approval of safe and effective crop protection chemicals to assist in the production of food and ornamental crops continues to be the central objective of the IR-4 Project. IR-4 is committed to provide the support required to give growers the tools they need to be successful and competitive. In most cases IR-4 develops residue data on food crops and pesticide efficacy/crop safety on ornamental species to support new registrations for these specialty crops. However, the need for product performance data on food crops has increased over the past few years. This is mainly due to the companies requesting some efficacy and/or crop safety data prior to marketing a new use. IR-4 efforts to expand crop groups and use of extrapolation based on our residue studies have all contributed to the greater need for efficacy and crop safety data.Outputs: This accountability document captures IR-4's numerous accomplishments, successes and deliverables for 2011 as well as presents on-going efforts to sustain IR-4's service to our stakeholders who are involved with managing pests of specialty crops and other minor uses. IR-4's 2011 accomplishments include:
Food Program - EPA approvals supported 382 potential new registrations. Of these, 220 already appear on product labels and IR-4 expects the majority of those remaining were registered in time for the 2012 growing season. Other notable deliverables in the Food Program include:
- 90 New studies conducted to answer specialty crop pest needs
- 179 New petitions submitted to EPA to establish pesticide tolerances and support registrations on 31 chemicals
- 2 Proposals to enhance Crop Groups submitted to EPA
- 4 IR-4 data packages submitted to the Codex Committee of Pesticide Residues or to foreign regulatory authorities to support US exports of specialty crops.
The IR-4 Ornamental Horticulture Program - was involved with 11 registrations which influenced the use of pesticides on 2572 species of non-food crops.
Biopesticide and Organic Support Program - with IR-4 regulatory assistance and data, EPA approved new biopesticide registrations for Bacteriophage of Clavibacter michiganensis subsp. michiganensis on tomato and Aspergillus flavus AF 36 on corn.
Public Health Pesticide Program - achieved key milestones in 2011, including submission of the first regulatory package to EPA for expansion of registration for a new reduced risk product for adult mosquitos and the submission for an experimental use permit for a reduced risk insecticide to manage Asian tiger mosquito in urban environments.
IR-4's Global Initiatives - continued to provide global leadership in the harmonization of Maximum Residue Levels for pesticides on specialty crops. Through pilot research projects and the Global Minor Use Summit-2, IR-4 provides value to growers in the U.S. and throughout the world.Activities: Activities in 2011 that will support future deliverables/registrations on food crops involves the initiation of 90 residue studies that consists of 512 field trials. The Canadian Pest Management Programme participated in studies in 2011 by contributing 59 field trials. IR-4 also conducted over 79 Efficacy and/or Crop Safety trials conducted on food crops to answer the product performance data requirements for 26 projects. IR-4 Study Directors submitted 179 new residue tolerance petitions to EPA. Additional activities in other areas include:
- At the 2010 FUW two new products, BYI-02960 (insecticide) and QGU-42 (fungicide), were selected by IR-4 stakeholders as high priority products on a number of commodities. The cooperating registrants provided some assistance to IR-4 by agreeing to include analysis of IR-4 samples with their own analytical work. As well, both registrants have already agreed to submit the IR-4 data to EPA as part of their initial submission for these products and pay the associated fees to EPA. After a very successful collaborative effort by every facet of the IR-4 Project (and the Pest Management Centre in Canada), IR-4 completed all of the required field work for these projects in 2011 and the samples are currently being analyzed. IR-4 expects the results from this collaboration will be registrations for new products as early as 2014 for BYI-02960 and 2015 for QGU-42. As an added bonus, these products are being considered for Global Joint Reviews by a number of countries and should therefore have global MRLs in place.
- The IR-4 Project, with input from the International Crop Grouping Consulting Committee (ICGCC), continues to lead an effort to update the US and Canada crop group regulation to incorporate "orphan" crops that are not currently members of a crop group, and to develop new crop groups and subgroups. The ultimate goal is to increase efficiency in data development/data review associated with pesticide tolerances and to pursue a harmonized international crop grouping system to facilitate international MRLs and international trade. Proposed revisions to the Leafy Vegetables Crop Group 4, Brassica (Cole) Vegetable Crop Group 5 and the proposed new group Stalk, Stem and Leaf Petiole group were submitted to the EPA in 2011. These crop groups were analyzed by the EPA's Health Effects Division and then were reviewed by the Chemistry and Safety Advisory Council (ChemSAC) with input from the Canadian Pest Management Regulatory Agency (PMRA). The ICGCC and IR-4 are also currently working on revisions to the Root and Tuber Crop Group 1 and Leaves of Root and Tuber Vegetables Crop Group 2. 21 data summaries were compiled based upon research reports submitted by researchers.
- In 2011, IR-4 conducted 1,199 ornamental horticulture research trials to support registrations in the greenhouse, nursery, landscape, Christmas tree, and forestry industries. Of these 572 were efficacy trials designed to compare different products to manage pests, diseases and weeds and to measure the impact of growth regulators; the remaining trials were conducted to determine the level of phytotoxicity to crops with herbicides used to manage.
- Also in 2011, the biopesticide grant program funded 6 Early Stage, 12 Advanced Stage and 4 demonstration Stage projects. These were conducted by 17 different universities and USDA research units and on fruits and vegetables, tropical crops, honeybees, turf and ornamentals. The demonstration stage grants were co-reviewed by EPA and IR-4. From this IR-4 submitted amended volumes for Bacteriophage of Clavibacter michiganensis subsp. michiganensis on tomato, and Aspergillus flavus AF36 on pistachio. New registration packages were submitted for Oriental beetle pheromone and carob moth pheromone. IR-4 submissions for EPA biochemical classification included packages for hops beta acid and Lysine. In 2011, registration approvals included Bacteriophage of Clavibacter michiganensis subsp. Michiganensis on tomato and AF36 on corn.
- IR-4's newest initiative, the Public Health Pesticide (PHP) Program, assists in the development and registration of minor use of pesticides that protect the public from vector-borne diseases such as West Nile Virus or Lyme Disease. Additionally, the public faces risks from the reintroduction of malaria or the emergence of novel diseases such as Dengue Fever spread by mosquitoes, ticks, sand-flies, and other disease vectors, as well as the nuisance, economic costs, and loss of enjoyment of public and private areas caused by these public health pests. The IR-4 PHP Program is cooperatively funded by the Department of Defense (DoD), through the Deployed Warfighter Protection Program (DWFP), and the USDA-ARS. IR-4's role is to identify potential new or underutilized vector control tools and to assist with the development and regulatory needs of vector control products.
In 2011, the PHP program completed a number of significant specific regulatory submittals. A first-ever magnitude of the residue study by IR-4 on ultra-low-volume (ULV) spray applied from a moving aircraft was completed, and the data was submitted to EPA with a request for an all- crop tolerance for the mosquito adulticide etofenprox. IR-4 facilitated Experimental Use Permits (EUP's) for the states of Florida and New Jersey to allow experimental applications by the U.S. Navy and the Rutgers University Center for Vector Biology of the insecticide pyriproxyfen to manage Asian tiger mosquito in urban environments.
Milestones: Another highlight in 2011 was IR-4's response to EPA's challenge to IR-4 to increase efficiency by bundling as many uses as possible around each active ingredient submission. On March 28, 2011, IR-4 submitted 5 administrative volumes for 5 active ingredients, 14 final reports (IR-4 studies), 21 end-use product labels, and 78 tolerance requests to EPA. This was the largest bundled submission in IR-4 history and will likely provide more than 350 new uses to growers. IR-4 also submitted a large number of data packages to Joint Meeting on Pesticide Residues (JMPR) in 2011 that will be used to establish Codex MRLs. These submissions included four active ingredients covering over 30 commodities.
Impacts: The specific successes, accomplishments and deliverables for the Food Use Program, Ornamental Horticulture Program, the Biopesticide and Organic Support Program and the Public Health Program of the IR-4 Project are documented in the IR-4 Annual Report (http://ir4.rutgers.edu/Other/AnnualReports/2011%20Annual%20Report.pdf).
Without the existence of the IR-4 Project, few safe and effective crop protection chemicals and biological alternatives would be available for use on food and ornamental specialty crops and minor uses.
In an effort to capture a solid assessment of program value, the IR-4 Project commissioned Michigan State University's Center of Economic Analysis to conduct a study on the economic impact of IR-4 Project's activities in the Food, Ornamental Horticulture and Biopesticide and Organic Support programs. Please note the Public Health Program, because of the limited time in operation, was not included in the study. The Executive Summary of the report noted, "Well-established methods of measuring direct and secondary economic impacts are used to gauge the contributions of the IR-4 Project and its three primary programs, including the Food Crops, Ornamental, and Biological and Organic Support programs in terms of sales, employment and gross domestic product. It should be noted that estimated economic impacts do not take into consideration health or environmental impacts, or associated economic outcomes of such impacts. Economic impact estimates do measure the direct and secondary effects of IR-4 registered pesticides' contribution to increased agricultural output of minor use crops and associated impacts of IR-4 expenditures for research and pesticide registrations. The findings suggest that each program posits real economic benefits to growers and the economy as a whole. Specifically, growers benefit in higher yields with higher quality output, consumers benefit by higher varieties and lower costs to food and ornamental crops, and the industry benefits through better global competitiveness of U.S. output. Including all secondary impacts, the IR-4 Project is anticipated to support research and industry sales sufficient to support 104,650 U.S. jobs and bumps annual gross domestic product by $7.3 billion." The report went on to break down the specific contributions of the three core research objectives and noted that the Food Program generates economic activity sufficient to support 87,792 US jobs and add $6.1 Billion to the annual gross domestic product.
Impact Statements:
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