Progress 09/01/08 to 08/31/11
Outputs
OUTPUTS: Objective: The IR-4 Quality Assurance program: The IR-4 Quality Assurance (QA) program staff at IR-4 HQ at Rutgers University, U. C. Davis, Michigan State University and the University of Florida conducted multiple inspections of field residue trials at USDA ARS test locations in the states of South Carolina, Georgia, Texas, Ohio, California, Arizona and Washington. The QA program staff also audited residue field trial data, analytical laboratory summary reports/data packages and study final reports which contained the analytical results from samples generated at USDA ARS research test sites. During the period of September 1, 2008 and August 31, 2011 members of the IR-4 QAU conducted facility inspections at 10 USDA ARS testing locations (conducting 11 separate facility inspections), 80 critical phase inspections of field trial study procedures, audited ~267 IR-4 field data notebooks (from USDA ARS test sites), 4 analytical summary reports and conducted final report audits for 39 studies (commodity samples had been analyzed for residue levels by USDA ARS analytical laboratories). Of the audits conducted in association with the monitoring plan for USDA test sites, Ken Kanagalingam conducted 13 final report audits that include auditing of field study records, analytical summary reports, and analytical raw data. Objective - Ornamental Horticulture Research Activities: The NJ Ornamental Research Center in Cream Ridge, NJ addressed several of the High Priority Projects out of the 2007 and 2009 IR-4 Ornamental Horticulture Workshops. From September 15, 2009 to August 31, 2011, this site conducted research on Herbicide Crop Safety and White Grub Efficacy. It also conducted a project examining pre plant intervals for halosulfuron. For Herbicide Crop Safety, 5 herbicides were examined for phytotoxicity on 24 different field container crops (not all herbicides were tested on all crops). For the Halosulfuron project, data were collected on crop safety for 7 crops (Juniper, Spiraea, Daylily, Rose, Echinacea, 2 Impatiens cultivars) treated in 2009 with final data collection in May 2010. For the White Grub Efficacy, field grown arborvitae were treated with either drenched liquid or broadcast granular insecticides in August 2009; these young trees were then removed from the ground in March 2010 and destructively harvested to count oriental beetle larvae. All research reports were posted to the IR-4 website (http://ir4.rutgers.edu/Ornamental/Ornamentals.cfm). In addition, summary reports were written compiling this data with other researchers studying the same projects. These reports are posted to the IR-4 website (http://ir4.rutgers.edu/Ornamental/ornamentalSummaryReports.cfm) and sent to manufacturers to be used to write new labels or update existing labels with EPA and state registration departments. PARTICIPANTS: Jerry J. Baron, IR-4 Headquarters, Executive Director; Tammy W. Barkalow, IR-4 Headquarters, Assistant Director HQ QA; Cristi L. Palmer, IR-4 Headquarters, Ornamental Horticulture Manager; Tom Freiberger, Rutgers Fruit Research and Extension Center (Cream Ridge Research Center); David Bodine, Rutgers Fruit Research and Extension Center (Cream Ridge Research Center); Zhongziao (Michael) Chen, PhD, Regional Quality Assurance Coordinator, Michigan State University; Kathleen Knight, Regional Quality Assurance Coordinator, University of Florida, Gainesville; James McFarland, Regional Quality Assurance Coordinator, University of California, Davis; Ken Kanagalingam, PhD, AJK Consultancy; Commodity Liaison Committee (CLC) - high value specialty crop growers and food processors are represented throughout the process and in overall management decisions by involvement on the Commodity Liaison Committee (CLC), consisting of approximately 25 members; Crop Protection Industry - IR-4 would not have new products to make available as crop protection tools for specialty crop growers without the cooperation of the biopesticide and chemical companies, who discover, develop, register, and market their new technologies. IR- 4 personnel visit regularly with these companies to maintain connections and obtain new information; US Environmental Protection Agency (EPA) is a long term IR-4 partner - IR-4 meets formally at least three times a year with EPA to discuss new regulatory approaches and ways to enhance the ongoing petition submission/review process, improving regulatory efficiencies, data requirements, and research collaboration. TARGET AUDIENCES: The primary stakeholders of IR-4 research activities are the domestic growers of specialty crops and food processors have significant involvement with the operations of IR-4. All sponsored research is stakeholder driven and 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. IR-4 research activity is a direct reflection of the priorities set at these workshops by the primary stakeholders. PROJECT MODIFICATIONS: Nothing significant to report during this reporting period.
Impacts
IR-4 Quality Assurance program: The FIFRA GLPs require all GLP studies to be monitored at intervals adequate to ensure their integrity. QA monitoring is twofold: 1) the inspection of personnel and study procedures; and 2) the auditing of the study data to assure final reports reflect all data. The monitoring and auditing of the field portion of studies conducted by USDA-ARS research scientists and the final reports containing this data is performed by the IR-4 QAU. This cooperative union between IR-4 and the USDA-ARS permits both entities to maintain highly skilled personnel who share their expertise with each other for mutual benefit, thereby reducing the need to support redundant staff. The QAU personnel from the IR-4 HQ and IR-4 Regional Offices periodically travel to USDA-ARS field test sites and analytical laboratories to audit study procedures, facility equipment, personnel, data and final reports to assure compliance with the IR-4 protocol and the GLPs. The results of the inspections and audits are reported, as required by 40 CFR 160.35. The QA reports were provided to the test site staff, the Study Directors (SD) at IR-4 HQ and to Testing Facility Management (TFM) according to the GLPs. These inspection/audit reports were utilized by test site staff, the SD and TFM in taking appropriate corrective actions and compliance assessments of the studies conducted as part of the IR-4 mission. Ken Kanagalingam audited 13 final reports as part of this grant, that included field study data, analytical reports, and analytical raw data. Ornamental Horticulture Research Activities: Research activities at this site are critical to meeting the IR-4 mission of safe and effective pest, disease, and weed management tools. Outputs from here are compiled with testing throughout the US to determine whether new or existing products will be efficacious against the target problem or will harm crops. Registration impacts often occur several years after research is complete. Fifty-eight impacts occurred during the three years of this grant on research conducted from 2005 through 2009. However, the research conducted in 2009 has led to 3 impacts on two herbicide labels: Freehand (2 crops added) and Tower (1 crop added). For other products in this experiment, a number of crop/herbicide combinations exhibited sufficient levels of injury that growers should not apply these herbicides on those crops. Other combinations did not exhibit injury and with other corroborating research, manufacturers will be able to add these crops to the appropriate labels. For the halosulfuron plant back project, no injury was observed with any of the pre-plant application timings for the crops tested. These results will aid the manufacturer in adding field in-ground nurseries to the halosulfuron label, expanding grower choices. The oriental beetle research is unique in that nowhere else in the US researchers are utilizing plant materials grown in ground and destructively harvesting to determine treatment efficacy. Growers and manufacturers have no other resource for testing efficacy under these conditions for this established, exotic organism.
Publications
- No publications reported this period
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Progress 09/01/09 to 08/31/10
Outputs
OUTPUTS: Quality Assurance: The IR-4 Quality Assurance (QA) program staff at IR-4 HQ at Rutgers University, U. C. Davis, Michigan State University and the University of Florida conducted multiple inspections of field residue trials at USDA ARS test locations in the states of South Carolina, Georgia, Texas, Ohio, California, Arizona and Washington. The QA program staff also audited residue field trail and analytical laboratory data and the final reports which contained the analysis results of trials conducted at the USDA ARS research test sites. During the period of September 1, 2009 and August 31, 2010 members of the IR-4 QAU conducted facility inspections at 4 USDA ARS testing locations, 28critical phase inspections of field trial study procedures, audited ~70 IR-4 field data notebooks (data generated a the USDA ARS test sites), 2 analytical summary reports and conducted final report audits for 16 studies where field samples had been analyzed for residue levels by USDA ARS analytical laboratories. Of the audits conducted in association with the monitoring plan for USDA test sites, Ken Kanagalingam conducted nine final report audits that include auditing of field study records, analytical summary reports, and analytical raw data. Ornamental Horticulture Research: From September 1, 2009 through to August 31, 2010, this Center completed two 2009 protocols related to herbicide crop safety. A report was written about the impact of 5 herbicides on 24 different field container crops (not all herbicides were tested on all crops). Research was also completed examining whether pre-plant halosulfuron applications caused phytotoxicity to 6 crops; applications were made at crops were planted in the fall and evaluated multiples times after planting through May 12, 2010. These reports were shared with the respective manufacturers. PARTICIPANTS: Nothing significant to report during this reporting period. TARGET AUDIENCES: Nothing significant to report during this reporting period. PROJECT MODIFICATIONS: Nothing significant to report during this reporting period.
Impacts
Quality Assurance: The QAU monitors all IR-4 GLP studies, including those conducted at USDA-ARS research test sites. This monitoring requires QAU personnel from the IR-4 Headquarters and Regional Offices periodically travel to USDA-ARS field test sites and analytical testing laboratories to audit study conduct procedures, facility equipment, personnel and procedures, data generated at USDA-ARS field test sites and final reports to assure compliance with the IR-4 protocol and the GLP requirements. The results of the inspections and audits performed by the IR-4 QA program staff were the generation of inspection reports, as required by US FIFRA Good Laboratory Practice Regulations found in 40 CFR 160.35 3-6. The reports of QA program inspections and audits were provided to the test site location staff, the Study Director at IR-4 HQ and to the Testing Facility Management (TFM) designee (the Executive Director at IR-4 HQ or his designee) according to the requirements in the GLPs. These inspection/audit reports were utilized by test site staff, the Study Director and TFM in taking appropriate corrective actions and to conducting compliance assessments of the studies conducted as part of the IR-4 mission. Of the audits conducted in association with the monitoring plan for USDA test sites, Ken Kanagalingam conducted nine final report audits that include auditing of field study records, analytical summary reports, and analytical raw data. Ornamental Horticulture Research: For the general herbicide crop safety screen, a number of crop/herbicide combinations exhibited sufficient levels of injury that growers should not apply some of these herbicides on specific crops. Other combinations did not exhibit injury and with other corroborating research, manufacturers will add these crops to the appropriate labels. For the halosulfuron plant back experiment, no injury was observed with any of the pre-plant application timings for any crop except Echinacea, and for this crop the same level of foliar injury was observed with the untreated plants as well. These results will aid the manufacturer in adding field in-ground nurseries to the halosulfuron label, expanding grower choices.
Publications
- No publications reported this period
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Progress 09/01/08 to 08/31/09
Outputs
OUTPUTS: Objective - Quality Assurance: The IR-4 Quality Assurance (QA) program staff at IR-4 HQ, University of California, Davis, Michigan State University and the University of Florida conducted multiple inspections of on going field trials at USDA ARS test locations in the states of SC, GA, TX, OH, CA, AZ and WA. The QA program staff also audited field trail and analytical laboratory data and the final reports which contained the analysis results of trials conducted at the USDA ARS research test sites. During the period of September 1, 2008 and August 31, 2009 the IR-4 QAU conducted facility inspections at 2 USDA ARS testing locations, 27critical phase inspections of field trial study procedures, audited ~83 IR-4 Field Data Notebooks (data generated a the USDA ARS test sites) and conducted final report audits for 12 studies where field samples had been analyzed for residue levels by USDA ARS analytical laboratories; Objective - Ornamental Horticulture Research Activities: From September 15, 2009 through to the present, the NJ Ornamental Research Center continued working on two ongoing research projects: Halosulfuron preplant interval and oriental beetle efficacy. For the Halosulfuron project, data were collected on crop safety in October and additional assessments will be made Spring 2010. For the oriental beetle efficacy, the arborvitae and lilace plots were maintained in preparation for half the arborvitae plants being assessed for Oriental beetle larvae in April 2010 and in preparation for additional product applications during 2010. During this period, the Center began preparations for 12 trial examining metconazole and triticonazole crop safety on annual bedding plants. PARTICIPANTS: Jerry J. Baron, IR-4 Headquarters, Executive Director; Tammy W. Barkalow, IR-4 Headquarters, Assistant Director HQ QA; Cristi L. Palmer, IR-4 Headquarters, Ornamental Horticulture Manager; Tom Freiberger, Rutgers Fruit Research and Extension Center (Cream Ridge Research Center); David Bodine, Rutgers Fruit Research and Extension Center (Cream Ridge Research Center); Zhongziao (Michael) Chen, PhD, Regional Quality Assurance Coordinator, Michigan State University; Kathleen Knight, Regional Quality Assurance Coordinator, University of Florida, Gainesville; James McFarland, Regional Quality Assurance Coordinator, University of California, Davis; Ken Kanagalingam, PhD, AJK Consultancy; Commodity Liaison Committee (CLC) - high value specialty crop growers and food processors are represented throughout the process and in overall management decisions by involvement on the Commodity Liaison Committee (CLC), consisting of approximately 25 members; Crop Protection Industry - IR-4 would not have new products to make available as crop protection tools for specialty crop growers without the cooperation of the biopesticide and chemical companies, who discover, develop, register, and market their new technologies. IR- 4 personnel visit regularly with these companies to maintain connections and obtain new information; US Environmental Protection Agency (EPA) is a long term IR-4 partner - IR-4 meets formally at least three times a year with EPA to discuss new regulatory approaches and ways to enhance the ongoing petition submission/review process, improving regulatory efficiencies, data requirements, and research collaboration. TARGET AUDIENCES: The primary stakeholders of IR-4 research activities are the domestic growers of specialty crops and food processors have significant involvement with the operations of IR-4. All sponsored research is stakeholder driven and 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. IR-4 research activity is a direct reflection of the priorities set at these workshops by the primary stakeholders. PROJECT MODIFICATIONS: Nothing significant to report during this reporting period.
Impacts
Objective - Quality Assurance: The QAU monitors all IR-4 GLP studies, including those conducted at USDA-ARS research test sites. This monitoring requires QAU personnel from the IR-4 Headquarters and Regional Offices periodically travel to USDA-ARS field test sites and analytical testing laboratories to audit study conduct procedures, facility equipment, personnel and procedures, data generated at USDA-ARS field test sites and final reports to assure compliance with the IR-4 protocol and the GLP requirements; The results of the inspections and audits performed by the IR-4 QA program staff were the generation of inspection reports, as required by US FIFRA Good Laboratory Practice Regulations found in 40 CFR 160.35 3-6. The reports of QA program inspections and audits were provided to the test site location staff, the Study Director at IR-4 HQ and to the IR-4 Project Testing Facility Management (TFM) designee according to the requirements in the GLPs. These inspection/audit reports were utilized by test site staff, the Study Director and TFM in preparing appropriate corrective actions and to make compliance assessments of the studies conducted as part of the IR-4 mission; Of the audits conducted in association with the monitoring plan for USDA test sites, Ken Kanagalingam conducted six final report audits that include auditing of field study records, analytical summary reports, analytical raw data, previous quality assurance reports and the 10 audit of field data books; Objective - Ornamental Horticulture Research Activities: The experiments are being planned (metconazole & triciconazole crop safety) or are in progress (Halosulfuron preplant interval and oriental beetle efficacy).
Publications
- No publications reported this period
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