November 14, 1995
Meeting of The Southern Association of AgriculturalExperiment Station Directors
Agenda Item 1
Presenter: Dr. Jerry Arkin
Members of the Association were invited to contribute agenda items, which have been included in the final agenda which was circulated in advance of this meeting. Members are invited to offer any further changes to the agenda.
Modification and adoption of the agenda.
Dr. Arkin called the meeting to order at 3:15 p.m.
The agenda was modified to include discussion of the regional IPM program by Dr. Crowder and then adopted as modified.
Agenda Item 2
Presenter: Dr. Jerry Arkin
The minutes of the previous meeting were sent to Directors in the Interim.
Modification if needed and approval of the minutes of the last meeting.
Dr. Tipton made a motion, seconded by Dr. Coston, to accept the minutes of the previous meeting in Clearwater, FL on July 16, 1995. Motion passed.
On the motion of Dr. Scifres, seconded by Dr. Helms, the interim actions of the Chair were approved.
INTERIM ACTIONS OF CHAIR
NOVEMBER 3, 1995
1. Approved and submitted for consideration by the Committee of Nine the following projects:
“Parameter Sensing and Control Systems for Drying Agricultural Commodities” – Replacement for S-235 developed under DC 93-04
“Biological Control of Selected Arthropod Pests and Weeds” – Replacement for S-238 developed under DC 93-09
“Evaluation and Development of Plant Pathogens for Biological Control of Weeds” – Replacement for S-234 developed under DC 93-07
2. Approved and submitted for consideration for one year extension by the Committee of Nine the following project:
S-242 “Physiological and Ecological Relationships Affecting Biting Flies and Ticks on Pastured Cattle”
3. Approved request for Technical Committee of S-216 “Food Demand and Consumption Behavior” to meet outside the region on October 12-13 in Las Vegas.
4. Approved request for Technical Committee for S-267 “Biological Control of Selected Arthropod Pests and Weeds” to meet outside the Southern region in Washington, DC, February 25-26, 1996.
5. Approved request for S-251 “Genetic Enhancement of Health and Survival for Dairy Cattle” to meet outside the region on October 19-21 in Kansas City.
6. Approved request for Technical Committee for S-226 “Enhancing Beneficial Microorganisms in the Rhizosphere” to meet outside the region in St. Louis during ASA meetings in November.
7. Appointed Drs. Tom Helms, Johnny Wynne, Charley Scifres, Ken Tipton, Don Richardson and Richard Jones to serve on the Search Committee for the SAAESD Executive Director position.
8. Following receipt of letter of resignation, completed arrangements for extension of Dr. Neville Clarke’s contract and memorandum of agreement with the Texas Agricultural Experiment Station.
9. Held a “fly-in” meeting at Atlanta Airport of Southern Directors on September 20 to discuss the SAAESD Executive Director position.
10. Appointed Dr. Larry A. Crowder to serve as Chairman of the Southern Regional IPM Committee.
11. Appointed Dr. Tom Helms to serve on the Program Planning Committee for next year’s Mini-Land Grant Meeting.
12. Appointed Dr. Larry Crowder to serve on the CRIS Sort Strategic Planning Committee.
13. Appointed Dr. David Teem as Co-Administrative Advisor for SERA-IEG-3 “Integrated Pest Management.”
14. Appointed Dr. Lalit R. Verma as Co-Administrative Advisor for SERA-IEG-24 “Composting and Compost Utilization.”
15. Appointed Dr. Richard L. Jones as Co-Administrative Advisor for SERA-IEG-1 “Southern Region Pesticide Impact Assessment Program.”
16. Appointed Dr. Graham Purchase as Co-Administrative Advisor for SERA-IEG-2 “Food Safety.”
17. Appointed Dr. J. I. Sewell as Co-Administrative Advisor for SERA-IEG-4 “Mechanization and Post Harvest Technology of Fruits and Vegetables.”
18. Polled the Association for preference on authorizing a $100,000 commitment of PL89-106 funds for a joint research/EPA program.
Agenda Item 3
Presenter: Dr. Jerry Arkin
CSREES is developing plans for implementation of the GPRA and has involved its SAES partners, along with other parts of the LGU family to participate in setting goals and developing indicators of progress towards achieving these goals. Regional Associations are represented at the policy level by the current chairs and broader working groups are being formed to undertake the more detailed planning of the USDA implementation plan.
ESCOP has taken the position that the joint SAES-USDA Strategic Research Plan will be the point of departure for defining the shorter term focused goals for the GPRA.
The Government Performance and Results Act (GPRA) Update from CSREES is attached.
The purpose of this agenda item is to provide information to Southern Directors about the purpose and implementation of the GPRA process and to highlight the implications at the SAES level for this activity.
Discussion, identification of any action items and ongoing participation in the GPRA process.
Dr. Cooper presented an overview of the Government Performance and Results Act (GPRA).
A meeting is planned for December 6-8, 1995 in Memphis, TN with representative from the states and CSREES staff to establish outcomes and indicators for the goals and objectives of the agency strategic plan. This activity is to help meeting the March, 1996 deadline. Approximately 120 participants are expected at the Memphis meeting. Four individuals have been identified for the SAAESD–Dr. Helms, MS; Dr. Young, NC; Dr. Brown, LA; and Dr. Clarke. Since Dr. Clarke will be unable to attend, a replacement will be named by the Chair.
Dr. Arkin is the representative for SAAESD to serve on the GPRA Council. His appointment was based on being the Chair, but he will continue to serve until mechanisms for rotating membership on the council are established.
Dr. Onstad submitted a draft copy of the ARS Strategic Plan to the Executive Director. A question was raised concerning input from the SAES partners. Dr. Onstad responded that even though SAES was not represented in drafting the ARS Plan, they had opportunity for input.
Southern Directors remain concerned about the complexity of the GPRA process, its vital importance to the future funding stream from USDA, and the compressed time schedule available to complete the task of setting goals, defining objectives and developing quantitative indicators against which progress will be measured towards achieving objectives and goals. There was concern about the lack of convergence of planning between the various parts of the REE mission area and the lack of involvement of the state partners in the development of the REE strategy.
Accordingly, on the motion by Dr. Scifres, seconded by Dr. Fischer, the Association voted to ask its Chair to send a letter to Dr. Stauber, endorsing the concerns expressed by ESCOP on the same subject and urging that actions be taken to ensure a more measured and realistic approach to this important activity.
Government Performance and Results Act (GPRA) Update
The first meeting of the GPRA Council was held in Washington, D.C. on October 17-18, 1995. The Council membership is comprised of the CSREES Deputy Administrators and representatives from the university partners. This meeting represented the first coordinated attempt to link state research, extension and higher education program planning and evaluation to the Federal GPRA mandate.
The university partner representation and members are:
Administrative Heads – Bob Helgesen (MA);
NAPFSC – Gregory Brown (VA);
ECOP – Carl O’Connor (WI), Trish Sacks (MA), Chester Fehlis (TX), Corinne Lyle (ID);
ESCOP – Gerald Arkin (GA), Daniel Rossi (NJ), Darrell Nelson (NE), Gary Cunningham (NM);
Board on Veterinary Medicine – Edward Mather (MI);
1890 Research – Walter Hill (AL);
1890 Extension – Ron Williams (AL);
ICOP – David Acker (IA);
ACOP – Joe Kunsman (NASULGC), John White (VA); and
Board on Home Economics – Karen Craig (NE).
The Council Co-Chairs are Carl O’Connor (WI) and George Cooper (CSREES).
GPRA Council Actions:
Adopted the Joint Council on Food and Agricultural Sciences FY 1997 Priorities as the Broad Goals for GPRA planning. These Goals replace the six program areas included in the earlier version of the GPRA Blueprint.
Goal 1. Achieve economically viable agricultural production systems that are compatible withenvironmental and social values.
Goal 2. Provide a safe, affordable, reliable, and nutritious food supply.
Goal 3. Educate agricultural scientists and professionals to meet future challenges.
Goal 4. Improve global competitiveness of U.S. food, agricultural, and forest products.
Goal 5. Empower individuals, families, and communities to improve their quality of life.
Goals will be managed to provide information on GPRA that will be useful in reporting at the Federal, state and local levels.
The Council proposed having a National GPRA Conference that will invite partner representatives from research, extension and higher education and CSREES senior program staff to develop a five year strategic plan and a framework for performance planning and evaluation. Leadership for the five program teams will be provided by Co-Chairs from the Council: Leaders will be: Ralph Otto and Chester Fehlis (Goal 1); Alma Hobbs and Karen Craig (Goal 2); James Coulter and John White (Goal 3); Edward Wilson and Gary Cunningham (Goal 4); and Marvin Konyha, Ron Williams and Corinne Lyle (Goal 5). It is excepted that the GPRA teams formed for the Conference will utilize existing state, regional and national planning initiatives to build future planning and evaluation initiatives and recommend evaluation studies and other ways to verify reports as required by the law. The teams will work together on proposed outcomes and define program activity relationships within the structure of GPRA and the CSREES Strategic Plan. An outcome will be the development of program outcomes and performance indicators that will focus on important agricultural issues. Each team will also have individuals experienced in program planning and evaluation and the development of performance measures. Participants at the Conference will be selected from nominations made by the Council. Attendance at the Conference will be limited to 120 participants.
The National GPRA Conference is tentatively scheduled for December 6-8, 1995 in Memphis, Tennessee. An agenda is being developed by the Council and will be shared shortly.
Following are the goals of the GPRA:
Goal 1. Achieve Economically Viable Agricultural Production Systems That are Compatible With Environmental and Social Values.
- Address the Structure of U.S. Agriculture
- Develop Improved Agricultural and Forest Management Systems that are Compatible with Natural Ecosystems
- Endure that Agricultural and Forestry Practices Protect Natural Resources and Improve Environmental Quality
- Protect, Conserve, and Improve Air, Soil, and Water Resources
- Improve Private Forest Management
- Manage Ecosystems to Conserve and Enhance Biodiversity
- Integrate Diverse Scientific Information into Efficient Management and health Systems
- Define the Determinants of Animal Well-Being and the Relationship of those Determinants to Animal Health
- Understand Fundamental Plant Processes
- Develop and Transfer Information on Management for Increased Productivity and Sustainability of Natural Resources on Public and Privately Owned Lands
Goal 2. Provide a Safe, Affordable, Reliable, and Nutritious Food Supply.
- Understand Relationships among Human Nutrition, Health, and Well-Being
- Enhance Food Quality, Safety, and Value
- Enhance Public Confident in Food Safety and Quality
- Provide Optimal Nutrition for Human Health
- Develop Technologies to Detect Beneficial and Harmful Constituents in the Food Supply
- Control or Eliminate Safety Hazards in the Food Supply
Goal 3. Educate Agricultural Scientists and Professionals to Meet Future Challenges.
- Develop Faculty to Enhance Scientific Expertise
- Strengthen Curricula to Meet Changing Needs
- Improve the Quality of the Scientific and Professional Workforce
- Improve Education Thorough Innovative Delivery Systems and Teaching Methods
- Develop and Reward Master Teachers to Meet the Needs of a Changing Global Food and Fiber System
- Develop Human Capital through Innovative Curriculums and Information Delivery Systems that Reflect Current and Future Changes in Food and Natural Resources Systems
- Recruit, Nurture, and Prepare Under-Represented Populations for Careers in the Food and Natural Resources Systems
- Promote Multidisciplinary, Multi-Institutional, and International Partnerships to Ensure Greater Access to Information and More Effective Problem Solving
Goal 4. Improve U.S. Global Competitiveness of U.S. Food, Agricultural, and Forest Products.
- Develop New Uses for and Add Value to Agricultural and Forestry Products
- Use Biotechnology to Improve Plants and Animals
- Enhance U.S. Agricultural and Forestry Competitiveness
- Create Niche Markets for Small Farmers and Agribusinesses
- Protect Plants for Sustained Productivity
- Maintain and Improve Agriculture’s Resilience and Regenerative Capacity
- Integrate U.S. and World Agricultural and Forestry Goals
- Minimize Production Costs of Tradeable Commodities
- Provide Research Base for New and Differentiated Products
- Provide Research Base for Quality Assurance Programs
- Identify Impacts of Public Policy on Competitiveness
Goal 5. Empower Individuals, Families, and Communities to Improve Their Quality of Life.
- Create and Environment Conducive to Rural Economic Growth
- Enhance Rural Economic Development
- Promote Individual, Family, and Community Well-Being in a Period of Social Change.
- Prepare to Live and Work in the 21st Century
- Determine the Effects of New Technologies on People, communities, and the Environment
- Promote Health, Safety, and Access to Quality Health Care
- Develop Indicators of Environmental Health
- Examine the Impacts of Societal Choices Related to Agriculture
- Enhance Self-Sufficiency of Individuals and Families Through the Extension of Research-based Programs
- Help Develop Economic Infrastructures that Attract and Sustain New Investments in Rural Communities
- Encourage Preventive Health Care and Wellness Programs
Agenda Item 4
Presenter: Dr. James Fischer
The Board on Agriculture has undertaken a set of Futuring Activities that are designed to provide an action plan for the Land Grant Universities in the area of Agriculture and Natural Resources. The purpose is to engage the broadly defined stake holders and gain their perspectives on the future needs and opportunities for the LGUs in this area. This is one of several coordinated activities now underway to define the future vision for the LGUs Three major events are planned: (1) a National Scoping Session which will define the major issues and opportunities to be discussed, (2) Regional Listening Sessions in which these issues and opportunities will be used to solicit inputs from stake holders, and (3) a National Synthesis Conference where a draft paper consolidating the regional inputs in the form of a proposed plan of action will be discussed and modified.
Drs. Jim Fischer and Zerle Carpenter are Co-Chairs of the Futuring Implementing Task Force.
The Kellogg foundation has provided funds to support the activities and The Mark Stanley Company has been engaged to facilitate the several activities. The National Scoping Conference has been set for January 25-26, 1996. Regional Listening Sessions will be held in the late February – May time frame.
It is envisioned that the Regional Associations of Experiment Station and Extension Directors, with representatives from regional Academic Programs will work together to:
- Help identify candidates for invitation to the Listening Sessions
- Provide advice to the Implementing Committee and Facilitators on any special needs or regional “spin” that might be relevant to the success of the Sessions
- Follow up on those receiving invitations, urging participation. Providing advice to Facilitators on those for whom transportation costs will be paid.
- Work with Administrative Heads of Agriculture in recruiting key participation.A further description of the Futuring Activities is provided in the attached material.
Discuss methods of engagement with other regional associations for planning and supporting the Southern Regional Listening Session
Discuss recruitment of key Southern regional representation at the Listening Session — linking this with future engagements of regional stake holders in the affairs of the SAAESD.
Propose a date for the Southern Regional Listening Session to be coordinated with other regional associations.
Establish an ad-hoc working group to engage the facilitators.
Dr. Fischer reviewed the status of the BOA Futuring Activities and sought the support of the SAAESD, along with other regional associations in helping to organize and recruit participants for the regional listening session.
Prior to the meeting, was decided by the Futuring Implementing Committee that the EDs in each region would engage the regional Extension Chair to coordinate the activities to be undertaken for the regional listening sessions.
Drs. Helms, Palmertree (the Southern Extension Chair), and Dr. Clarke agreed that the date of March 21, 1995 would be taken for the Southern Listening Session and that the meeting would be held in New Orleans. Dr. Clarke is to continue to act as liaison between Southern Extension and Experiment Station Directors.
We will plan to invite 50-60 participants, including those who might subsequently be recruited as part of a Southern Regional Political Action group. Recruitment is to be initiated as soon as possible to ensure participation of key people; limited funds from the Kellogg grant may be available to pay travel of those who are regarded as necessary and who would otherwise not be able to participate. Southern Administrative Heads of Agriculture will also be asked to help with recruiting where necessary.
Report to Southern Experiment Station Directors Meeting
November 14, 1995
Board on Agriculture Futuring Activities
James Fischer and Zerle Carpenter, Co-Chairs
The Board on Agriculture (BOA) of NASULGC is conducting a series of related meetings and workshops to develop the future agenda for research, extension, and higher education in LGU programs dealing with agriculture and natural resources.
A grant from the Kellogg Foundation will provide logistics support for these activities. The BOA Futuring Activities are part of a carefully coordinated set of complementary activities, several of which are sponsored by the Kellogg Foundation.
The scope of this effort will include the agriculture and natural resources activities of the LGUs. It includes the work of the SAESs, CESs, APs and IPs. The target audiences are both external and internal; including faculty and administrators, customers (broadly defined) and policy and decision makers at the local, state, and national levels.
Three activities will be conducted:
1. National Scoping Conference (January, 1996): A conference of customers and policy makers that will establish an agenda for subsequent regional conferences. This will assure that the relevant national issues are debated in more detail at regional meetings.
2. Regional Listening Sessions (April-May, 1996): Four or five regional sessions are planned in which a wide diversity of representatives from the public sector and from our customers and faculty will provide input to the futuring process. The indicative agenda developed at the national level will be addressed as a point of departure for these discussions.
3. National Synthesis Conference (July, 1996): The third session will be at the national level and will provide a forum for those involved in regional discussions as well as national leaders. The product of this conference will be a synthesis of the regional sessions and will be published in a variety of electronic, video, and printed formats. This conference will complete the Joint Futuring Activity.
Summary of activities to date:
Initial meeting of the Implementing Committee was held in February, 1995. Implementing Committee members are:
A. J. Dye
Grant from Kellogg Foundation was awarded in August, 1995.
Mark Stanley and Company has been selected to assist in facilitating the three activities. The facilitator’s duties will include conduct of the meetings, arranging logistics for the three activities, organization of breakout and planning sessions, provide video and audio of key sessions, preparation of reports, etc.
Implementing Committee and facilitators met on the afternoon of October 9 in Washington, DC to further refine the roles of the Implementing Committee and the facilitators. Duties of the facilitator were outlined. Advisory Committee met with the Implementing Committee and facilitators on October 10 in Washington, DC.
Subsequent to the Advisory Committee meeting, a conference call was conducted on October 19, 1995. Participants included Zerle Carpenter, Neville Clarke, Jim Fischer, Myron Johnsrud, Joe Kunsman, John Ramsey, Paul Weller. During the call, the date for the National Scoping Conference was suggested, to be during the week of January 22-26, 1996.
Facilitators to date have accomplished:
(1) Attended the CAST Workshop on October 14-15, 1995.
(2) Prepared paper on Advisory Committee input and summary of Implementing Committee actions.
(3) Confirmed dates of the National Scoping Conference.
(4) Prepared plan for the scoping conference. Plan will be presented at NASULGC meeting.
(5) Established dates for Regional Listening Sessions.
(6) Developed overall media plan.
Chairs of ESCOP and ECOP are asked to seek participation of administrators in USDA/REE.
This program is a serious effort to develop an action plan for agriculture and natural resources programs at land Grant Universities. This plan will include identifiable and measurable goals. This is a noble and necessary effort because it precisely addresses the requirements of the Government performance and Review Act (GPRA).
In order for this effort to be successful, we need the participation of the administrative heads of agriculture, working with the regional association chairs of teaching, research and extension, to:
— help identify candidates for invitation to the regional listening sessions.
— provide advice to the Implementing Committee and facilitators on any special needs or regional “spin” that might be relevant to the success of the sessions.
— follow up on those receiving invitations, urging participation and providing advice to the facilitators for whom transportation costs are necessary to achieve participation from their “stakeholder” group.
With this input, the facilitators and the Implementing Committee will attempt to set the time and location for the regional listening sessions by mid-November, 1995. Next conference call of the Implementing Committee is scheduled on Monday, November 6, 1995.
Agenda Item 5
Presenter: Dr. Charley Scifres
The Workshop was held on September 26, 1995 in Atlanta and was well attended with more than 60 participants from across the region.
The notes from the meeting are attached for information.
Information and discussion of any follow-on activities at the regional level to facilitate the implementation of GLP in the Southern SAESs.
Dr. Scifres reported that approximately 80 individuals attended this workshop and the there was very positive feed-back regarding its utility. Participants felt that the engagement should be continued and the Administrative Advisor agreed to develop a proposal for a new Information Exchange Group to provide a forum for this engagement. It was noted that the Group would select meeting sites at locations where active GLP programs are being practices. The Chair of the Technical Committee, Dr. Don Murray (OK) has agreed to prepare the proceedings of this workshop.
SAAESD CONFERENCE ON GLPs
September 26, 1995
Debra Garvin: Introduction to GLP Concepts
GLPs – THE BIG PICTURE
- Initial opposition strongest from universities
- corporate and consultant labs outdo universities
- graduate students do work
- GLP means more than good science
ENHANCE QUALITY AND INTEGRITY OF RESEARCH DATA
- Public scrutiny of scientific research
- public opposition to pesticides/genetic engineering
- regulator’s decisions based on sound science
- tighter budgets with less tolerance for mistakes
- passing of baton (multi-year research)
- independent (QA) oversight of projects (universities dislike most)
- not merely regulations
- understand intent, details are easy
- GLP contribute to good scientific and business principles
- equipment maintenance logs
- can be pick up by another scientist
- standardized procedures
- qualified and trained staff
- defined responsibilities
- prevent unnecessary repetition
- quality products
- study director control
- equipment calibration and testing
- chain of custody for test substances and all specimens
- complete reconstructibiity of studies
- good reliable data that stands up under scrutiny
FOUR STAGES OF GLP COMPLIANCE
- no way I’m gonna do that
- if I have to, but only what I must
- easier to apply to all
- pretty good idea
- prevent fraud
- ensure good science
- scientifically valid, documented, reproducible studies
- scientific review of all data and quality/validity of the science submissions
- internal evaluation of systems and facilities vs external (government) monitoring
- provide for an independent audit of data, records, and reports prior to EPA/FDA submission
GLP BOTTOM LINE
- good business
- good science
- reproducible studies
- directly related to management and researcher support
Steve Barker: Quality Assurance and the University State of MindVeterinary Medicine at LSU
- Academic reluctance to the process
- Growing dependence on external funds
- Demands from government and industrial customers for GLP
- Loss of potential revenue to contractors
- Grudging acceptance
- fundibility and patentability required by administration
- Growing use and compliance
- Increased funding and acquisition of quality students (hopefully)
- [Will the fervor for setting goals and defining indicators to measure success reflect on the objectivity of conducting and interpreting results of research?]
LACK OF EDUCATION ABOUT QUALITY ASSURANCE AND GLP IN THE UNIVERSITY SYSTEM
- eventually required to meet standards
- establish central QA authority
- teach QA/q, iso, GLP on undergraduate and graduate levels
- retrain/train staff, faculty, administration
- Seek early professional help in structuring programs
- formal training as part of research methodology
- primers for GLP
- layered administration limits effectiveness
- reporting level of QA officer to sufficiently high level to help avoid conflict of interest.
- use existing structure where possible — radiolabel use, i.e.
- complete records to avoid loss of useful info not recognized
- avoid stress of negative findings on external audits
- decision on central vs distributed QA/Q function — centralized is more efficient
Willis Wheeler: Quality Assurance: Potential for Multi-State Partnering
WHY Q/A IN SAESs
- required by regs
- improved documentation of research records
- litigation and patents
- student education
- FDA -21 CFR part 58
- EPA-40-CFR part 160
- TSCA-40-CFR part 702
WHEN IS GLP REQUIRED
- establish or modify tolerance or exemption
- responding to notice issued by EPA under FIFRA
- minor use crops account for 40% cash value of crops
- pest control for minor crops
- clearance of biologically based control alternatives
- onational program with four regional laboratories
- headquarters at Rutgers University
- Southern Regional effort: multiple field and laboratory locations, including ARS
- GLP implemented across four regions by having standard sops with appropriate flexibility. standard formats for protocols, standard check lists, standard field research notebook, standard reporting format.
ENHANCED PAPER TRAIL PROVIDES
- precision / accuracy
- document methodology
- increased communication
- improved study design
- standard procedures for record retention
- enhanced funding opportunities
- patents and other protection
- part of graduate education to expose students to these regulations and how to implement and comply with them
HOW TO GET STARTED WITH GLP IN A UNIVERSITY SETTING
- Organizational structure: Definitions under the law:
- quality assurance unit
- testing facility and its management
- Responsibilities of testing facility management
- designates and replaces a study director
- assures there is a QAU
- assures characterization of test, control, and reference substances
- assures availability of adequate personnel, resources, facilities, equipment, materials and methodologies
- Adopt GLP regulations to meet university/laboratory needs — something less than full compliance may be adequate — cost versus benefit after meeting minimum standards
- QAU report at the level of the Dean
APPROACH FOR A REGIONAL QAU
- EACH CAMPUS
- PAPER TRAIL
Responsibilities regional QAU
- oversight regional and on site
- education training of on site QUA
- development of effective framework for the process
- ensure that facilities and record keeping are adequate
- develop sops for QA procedures
- copies master schedules
- reports to mgmt
- other responsibilities required by regulatory authority
- campus resource to train faculty
IMPLEMENT A REGIONAL SYSTEM
- regional QAU at one institution
- QA travel to other instns
- trng and consultation
- facilities inspection
- contact person at each institution
- one broad system throughout the region
QA is an independent check that can benefit lots of people
- Management: accurate and clear paper trail — personnel, institutional
- Scientist: clear paper trail and work done according to protocol and established methods
- valuable asset to scientist, management and funding agency.
GRANTING OR AGENCY EXPECTATIONS IN THE YEAR 2001:A FUTURISTIC LOOK AT GLPs
FDA PERSPECTIVE Josephine Reed
Offices or Centers Reviewing or Accepting Data
- Office of Regulatory Affairs (ORA)
- Center for Drug Evaluation and Research (CDER)
- Center for Biologics Evaluation and Research (CBER)
- Center for Food Safety and Applied Nutrition (CFSAN)
- Center for Devices and Radiological Health (CDRH)
- Center for Veterinary Medicine (CVM)
Bioresearch Monitoring Program
- Pilot Inspection Program Initiated in 1977
- Proposed Good Laboratory Practices in 1979
- Proposed Amendment GLP 1984
- incomplete data submission to FDA
- Observations on dead animals
- Lack of understanding of procedures
- Inadequate drug administration records
- Non-conformance to protocol
- Protocol: “clearly indicates the objective and all methods for the conduct of the study”
- sops: “setting forth nonclinical laboratory study methods that management is satisfied are adequate to insure the quality and integrity of the data generated in the course of the study”
Recent GLP Observations
- protocols for some studies have not been signed by the sponsors
- reasons for raw data corrections are not consistently entered when corrections are made
- Personnel are not adequately instructed or are not properly trained
- test article inventory records are not adequately maintained
- Temperature excursion records are not reviewed and reported in a timely manner
Responsibilities under GLPs
- study director
- quality assurance
- quality assurance unit
- computer system (validation and set up)
- study directors
- test article
- raw data states what happens
EPA PERSPECTIVE (Francisa Liem) — A Futuristic Look at GLP
- 1976 FDA proposed
- 1980 EPA GLP proposed
- 1983 EPA and fda approved
- 1989 GLP amended (including microbials)
What Has Been Learned / Accomplished
- commitment has increased
- bad data has been reduced
- collaboration is a way of life
- flexibility and accountability have emerged together
EPA commitment to safe food in cost effective manner
Evolution of EPA’s Actions
- less time for review
- fewer questions
- fewer repeats
- 2001: GLP common practice in industry, laboratories, academia, and government
- Europe and Asia are already into GLP,
- aspires that LAC and Africa will join in
- Project more inclusive decision making process
- Data quality stewardship
- Streamlining of Agency regulations with removal of unwieldy and unnecessary
- More electronic storage and transmission of data
- Concept of increasing partnership between government, academia and industry with role of SAESs central agricultural studies.
INDUSTRY PERSPECTIVE (Catherine Templeton – Monsanto)
(desired interface with universities)
Industry is asking:
- what core competencies are key to business
- what skills should be purchased
- where will future opportunities arise
- how to compete globally
- what global alliances should be made
- what GLP regulations should be meet for given research
- how to generate top quality compliant research for lowest cost
Universities tend to have QA based more on individual tailoring while industry tends to be more formalized and have more consistent policies and procedures
Industry perceives that universities:
- don’t have organizational structure conducive to QA
- not widely accepted by faculty
- because of diversity, a large number of QA regs may not apply
- clear communications between PI and sponsor is essential
- formal QA is expensive, takes funds from research (up to 100% increase)
- historical records and long term archive space may not be available
- business procedures may hinder study conduct and impose new lead times
Universities might consider “business redesign” that is used in industry to remove road blocks to university-industry relationships — win-win.
What industry expects from a supplier:
- on time
- cost competitive
- pass purchaser and government inspections
- fit for use
- demonstrate continuous improvement of systems to solidify relationship
- develop the concept of a “preferred supplier”
What industry expects from supplier of research
- on time
- GLP standards and defined methods
- cost competitive
- pass supplier qualifications review (both technical and GLP compliance) and any governmental inspections
- systems in place to ensure compliance (sops)
- credible and stand up to thorough review by technical and business experts
- patentable and defendable
- cost effective and credible
Vision of regulator environment in 2001
- GLP and methods will be harmonized across government agencies world wide
- Labs will be certified providing some global monitoring and consistency — applicable to university labs doing GLP work
- GLP will reach further back into the development phase and also forward, i.e. labeling claims
- will be desirable to apply GLPs to other work to enhance research credibility
Industry / University partnership: benefits to both
- income opportunities for both
- cost effective source for industry of high quality experimental and other services
- universities increase credibility
- increase value of intellectual property
- strong patents
- marketability of students
Agenda Item 6
Presenter: Dr. James Fischer
At the July joint meeting of Southern Experiment Station and Extension Directors, the results of the Southern Experiment Stations analysis of individual state project contributions to sustainable agriculture was reviewed. Results of the joint conference on Agroecosystems was summarized. A joint task force was established to explore joint follow-on activities at the regional level.
The Task Force has met once by teleconference. The results of their deliberations are shown in the attached report.
The Task Force proposed that a follow-on group of scientists and specialists working in related areas be formed into a Task Force to determine further actions. SAES Directors will be asked to select representative current projects that might fit into the general framework of agroecosystems and submit them to this group for assessment. The goal will be to develop a general taxonomy or framework to define and categorize projects falling into the area of agroecosystem research. Through this more definitive categorization, it is expected that the task force will identify any opportunities for joint cooperative regional activities. Dr. Fischer was asked to work with the Extension Co-Chair to develop a proposal for this new activity and to submit it for consideration by the Associations.
SERA-Task Force on Sustainable Agriculture and Agroecosystems
James Fischer and David Foster, Co-Chairs
Report to Southern Experiment Station Directors
November 14, 1995
SERA-Task Force on Sustainable Agriculture and Agroecosystems was appointed on September 1, 1995. Members are:
Experiment Station representatives: James Fischer, co-chair; Robert Merrifield; Charles Scifres.
Extension Service representatives: David Foster, co-chair; Jack Bagent, Gaines Smith.
Charge: Assess background and determine if a cooperative effort between Southern Experiment Station and Extension Directors is needed. Develop recommendations for next step in organizing the effort.
Original intent was for a report to be presented at the Experiment Station/Extension Service directors’ joint meeting in July, 1995. This was not possible due to the proceedings of the Agroecosystems Conference held in April, 1995 not being available until September, 1995.
A conference call of the SERA-Task Force was held on October 11, 1995. Results of the call:
(1) Communication is necessary between scientists and specialists with disciplinary background in ecology and those currently conducting research and extension programs but who may not be aware of approaches used by the former group. Regional cooperative efforts are necessary at the basin, landscape or agroecosystem level where the geographical framework includes multiple states. Therefore, research and extension needs to further evaluate program efforts related to agroecosystems recommendations.
(2) One or two models that are presently underway in each state on ecological assessment be identified by Experiment Station and Extension directors. A team of research and extension scientists be appointed to conduct an assessment of these on-going efforts. From these assessments, the team will put together a theoretical agroecosystems model to include the main components that should be involved in future agroecosystems programs.
This model would contain methodologies than can be used to acquire and analyze data at the agroecological level, including development of measurements and analysis techniques that would support determining the impact of altered agricultural practices at the agroecosystem level.
(3) Finally, cooperative regional efforts are needed to develop extension and academic program educational material to communicate concepts and issues dealing with the impact of farming at the ecological level.
(4) Suggested next step would be formation of a team of faculty to carry forward this agenda. We are recommending the individuals who participated in the Agroecosystems Conference in April, 1995 be part of this team. For example: ecologist, Pat Werner, Florida; economist, Larry Libby, Florida; sociologist, Ronald Wimberley, NC; production agriculturist, William Hargrove, Georgia.
Disciplines that should also be included are plant pathology, entomology, engineering, agronomy, horticulture, soils, forestry, wildlife biology, ecology.
Agenda Item 7
Presenters: Drs. Ike Sewell and D. C. Coston
The report of SRRC was provided, and is available from the Executive Director’s office upon request.
Drs. Sewell and Coston reminded members that RRF project participants should have assigned resources and that the SAAESD have recommended that individual states support travel to regional RRF meetings. A new requirement for projects completing the fourth year will be that a “success story” be submitted with the annual report.
The Association commended the work being done by Dr. Ike Sewell, especially his willingness to serve a second term as Chair of SRRC. It noted his election as Chair of the Committee of Nine and the excellent record of quality of Southern Regional Research proposals being submitted for approval.
A C-9 workshop originally under consideration for the January, 1996 time frame is being delayed until the fall of 1996 because of the press of other regional activities.
Agenda Item 8
Presenter: Dr. George Cooper
The CSREES report follows.
See agenda item 3 for GPRA Update from CSREES.
Dr. George Cooper of CSREES made an excellent presentation of plans for the GPRA exercise under agenda item 3 — and the actions taken are reflected there. The remainder of the report was for information only.
Role of the CSREES Partnerships Unit
The Partnerships Unit will represent CSREES in discussions with partner representatives and the Research, Education and Economics Mission Agency in meeting program and budget expectations of GPRA; serve as CSREES representative in national strategic planning and budget planning initiatives with partners; manage the regional research fund research programs; coordinate CSREES initiatives that impact two or more CSREES units, two or more regions in partner initiatives and the broad program cross-cuts involving CSREES and other state, Federal, public and private partners; provide leadership in the CSREES/partner planning and evaluation reporting system and the development of program accomplishment reports; and serve as representative to the REE Office of Legislative Affairs in responding to program and budget issues.
Agenda Item 9
Presenters: Drs. Jerry Arkin and Tom Helms
In accordance with established procedures, Dr. Tom Helms, Chair-Elect of the Association will become the Chair during the meeting of the Association which occurs in conjunction with the annual NASULGC meeting.
A peaceful and orderly transfer of power and the instrument of office from the incumbent, Dr. Arkin, to Dr. Helms is anticipated.
Dr. Helms assumed the position of Chair of the Association and presented Dr. Arkin with a certificate of appreciation for his outstanding service as 1994-5 Chair. Dr. Arkin expressed his thanks to members for their support.
Agenda Item 10
Dr. Tom Helms
The incoming Chair provides a statement of major objectives and intent at the beginning of his/her term of office. The following plan is submitted.
The SAAESD Annual Plan was approved as presented by Chairman Helms.
Annual Plan for the Southern Association of
Agricultural Experiment Station Directors
November 14, 1995
It has become the custom for the incoming Chair to outline the set of major objectives for new and continuing activities of the Association for discussion by and approval of the members. The recent “fly-in” by members of the Association to discuss the replacement of the Executive Director provided a useful perspective in preparing this plan. At that meeting, it was agreed that the Association should continue to maintain and build the momentum that has been achieved in recent years. The following are some of the major activities that are proposed for the 1995-6 agenda.
- Recruitment of Executive Director:The job description and plans for the search have been developed and the search process has been initiated. It is intended that the new ED will be recruited and in place on or before May 1, 1995.
- Mid-Term Update of the SAAESD Strategic Research PlanSAAESD will develop a mid-term update of its strategy, initiating the planning process by seeking input from Advisory Committees, and completing drafting as a part of the April meeting of the Planning Committee and its Groups. The document will be published on the WWW, with an Executive Summary in printed form. Relatively minor updates and interpretation of the ESCOP Mid-Term Update are expected. Coupled with the following objective, the Association will take the opportunity to re-examine its vision and mission statement and make adjustments as deemed appropriate.
- Streamlining Functions of SAAESDThe review of functions and procedures for the Association was initiated at the February, 1995 meeting and continued at the April, 1995 meeting. We will have a focused agenda item on this subject at the February, 1996 meeting with the goal of adopting any new principles and procedures that can help the Association continue to move ahead while minimizing administrative transaction costs.
- New and Continuing ActivitiesThe April meeting will involve Planning Groups focusing on review of current regional and overall research portfolios and considering recommendations for new and continuing activities.
- Quality TimeWe will have the goal of expanding the amount of meeting time that is devoted to discussion of critical issues affecting the SAESs in the Southern Region. Members of the Association are encouraged to identify topics that should be discussed.
- National ActivitiesThe SAAESD will continue an active presence at the national level on behalf of members of the Association. With the ESCOP Chair rotating to another region, and with the retirement of the ED, the level of effort will be less next year. But, it is the consensus of the Association members, as revealed at our “fly-in” that a strong national presence is in the interest of the Association and should be pursued.
- SMISThe IEG-67 on GIS applications continues efforts to develop a method for effective use of the SMIS as a state and regional planning tool. An ad-hoc committee of directors and scientists to explore the use of SMIS has been formed. A poster session by the IEG is planned in conjunction with the February, 1996 meeting.
- Analysis of Southern Research PortfolioWe will continue the analysis of the total research project portfolio across the Southern region with the goal of providing an enhanced ability to assess ongoing research as this pertains to improving regional planning and cooperation.
- Relationship with Southern Extension Directors:A useful and productive engagement with Extension counterparts has been established and there are a number of active joint task force activities underway, along with the continuing SERAs. It is anticipated that we will continue and expand this relationship.
- Relationship with Administrative Heads and Other LGU Counterparts at the Regional Level:It is expected that there will be another meeting of the LGU agriculture community in the summer of 1996. SAAESD will take an active role in agenda setting and work towards a more meaningful definition of goals and objectives of this interchange.
- Regional Listening Sessions:SAAESD will support the Board on Agriculture Southern Regional Listening Session, in cooperation with Southern Extension and Academic Programs counterparts.
- World Wide WebThe Association will continue to use the WWW as a means of enhanced communication and publication of cooperative bulletins and other documents. The SAAESD home page, linked with those of members SAESs will be maintained and expanded.
Agenda Item 11
Presenter: Dr. Richard Jones
The SAES-USDA Strategic Research Plan was updated in August and the results will be on the WWW within the next few weeks. With this as a point of departure, the SAAESD plans to conduct a mid-term update of its strategy to be published shortly after the April, 1996 meeting. The following steps are relevant and are presented as a “heads-up” for those members having tasks related to this plan before the next meeting of the Association.
- Regional Advisory Committees should be asked to review the current SAAESD strategy and the revised SAES-USDA mid-term update and develop any recommendations they wish to have considered by directors for the SAAESD update.
- Chairs of Planning Groups are asked to examine these same documents and determine if there are any actions to be taken by their group to develop concepts for change prior to the February, 1996 meeting.
- The mid-term update will be an agenda item at the February meeting, where plans will be solidified as to approach and methods of engagement for the plan.
- It is proposed that the mid-term update be put up on the WWW and that a brief printed summary be prepared for distribution to our various stake-holders.
- The update will be undertaken as part of the April meeting with the goal of developing hard draft of the new document during the meeting and discussion and adoption of results of Planning Group deliberations in plenary session.
- Implementing procedures will be distributed on the WWW shortly.
For information and action by Planning Group Chairs and Administrative Advisors to our Advisory Committees.
The approach proposed above was adopted by consensus. The new Chair of the Planning Committee, Dr. Richard Jones, was acknowledged.
Agenda Item 12
Presenter: Dr. Jerry Arkin
At the February and April 1995 meetings we discussed reviewing and continuing to revise the functions and procedures for the Association with the goal of continuing to build momentum and take up changing agendas, but to look for ways to reduce administrative burden and transaction costs of operation. Substantial progress has been made this year with revision of procedures for managing the proposals for new and continuing activities and the new use of the World Wide Web for regional publications and updating administrative information. Both time and costs have been very substantially reduced.
It is proposed that at the February, 1996 meeting, a systematic look be taken at the “Guidelines for Southern Directors” to revalidate existing functions and procedures, eliminate or reduce those existing procedures for which there is no longer a perceived need, and to identify any new or emerging needs which should be incorporated.
It is suggested that an ad-hoc committee of Directors be asked to work with the Executive Director to bring a proposal to the February meeting for discussion, modification, and adoption by the Association.
The Association agreed by consensus to the proposed review by the Executive Director and the Chair will ask Drs. Wynne and Arkin to review the proposed modifications made by the ED. The revisions will be considered by the Association at its February 1996 meeting.
Agenda Item 13
Presenter: Dr. Neville Clarke
IEG-67 deals with the use of Geographic Information Systems for Research in the Southern Region. This group has also been involved with the planning, evaluation, and use of the Southern Management Information System. At their meeting last summer the group recommended:
- Putting the SMIS on the WWW and establishing a home page for sharing information on its use and for accessing a distributed set of relevant data bases. This has been accomplished.
- Establishing an ad-hoc committee of directors and scientists to explore use (not process) of the SMIS. This committee has been formed and will meet prior to the February meeting of the Association (its first meeting was cancelled because of weather).
- A poster session by members of IEG-67 at the SAAS meetings in conjunction with the meeting of SAAESD. This session would provide insight for the members of the Association on GIS/SMIS related activities across the region and would provide an opportunity for a brief dialogue between members of IEG-67 and the Association.
Discussion of the poster session and endorsement of participation. Leadership from the Association side would come from the ad-hoc committee described under the second bullet.
On a motion by Dr. Tipton, seconded by Dr. Fischer, the proposal for the poster section was endorsed. The December 1995 meeting of the Ad Hoc Committee to review SMIS uses will also report at the February meeting. The concept of early use of the SMIS for impact assessment was endorsed. The Executive Director is to make appropriate arrangements and to explore the interest of appropriate existing technical committees for regional projects that might use the SMIS. Continued development of agroecological zones to describe the resources of the Southern Region was endorsed.
Agenda Item 14
Presenter: Dr. Neville Clarke
It will soon be time for individual Directors to submit proposals for new, completed and continuing activities. These proposals are due in our office by January 15, 1996. As called for in our standard procedures, we will distribute the proposals to appropriate Advisory Committees and organize their responses for the various Planning Group sessions at the April meeting. As agreed last April, we will not send these proposals or the Advisory Committee recommendations on them to Planning Groups piece-meal (as previously done) but will make them available shortly before the April meeting.
Although most administrative advisors have probably already begun to do so, the purpose of this brief is simply to remind Directors that it is time to develop proposals.
Procedures and formats for the submissions are found in Guidelines for Southern Directors, pages III 32-44. They will also be accessible on the WWW.
Agenda Item 15
Presenter: Larry Crowder
Dr. Crowder advised that the FY 96 program RFP should be in the directors offices upon their return from the November meeting.
There are two programs in RFP. The first category is for IPM research projects, the same as always. $760,000 will be available and the same review process used. The second category is for joint IPM research/extension projects funded at $300,000 in each region; $100,000 from regular research funds, OTT to leverage 100,000 from extension, and the same amount from EPA. Funding is up to two years. Pre-proposals due December 21, 1995 for both.
Priorities for both programs are: general IPM science, vegetables and fruits, ornamental and turf, and cotton. The review mechanism for research/extension is not yet certain. Extension has no committee structure.
The RFP you received on IPM alternate projects to pesticides is a different program at the national level (Barry Jacobson heading-up). Implementation (what happened to it). ESCOP/ECOP decided to table the National IPM implementation program until additional appropriations are made at the federal level. Therefore, there will be no Phase II projects, but the Phase I teams can apply for the new joint research/extension projects.
None. For information only.
Agenda Item 16
Presenter: Charles Onstad
Dr. Onstad submitted a draft copy of the ARS Strategic Plan to the Executive Director. A question was raised concerning input from the SAES partners. Dr. Onstad responded that even though SAES was not represented in drafting the ARS Plan, they had opportunity for input.
Relating to the budget, ARS realized a decrease from $713 to $710 million. This resulted in a 1% cut across the board for projects.
In terms of the sixteen potential ARS facility closures, eight will be reorganized as “work sites”, and will not be listed as ARS facilities. Four are still on the potential closure list, but no action is expected in the near future.
None. Information only.
Agenda Item 17
Presenter: Neville P. Clarke
Dr. Robert G. Merrifield retires on December 31, 1995. He has served the Southern Directors in a number of roles since 1977. A resolution recognizing his contribution has been prepared.
Adoption of the resolution by the Association.
The resolution was unanimously adopted as signified by a standing ovation for Dr. Merrifield.
Dr. Robert G. Merrifield
The Southern Association of Agricultural
Experiment Station Directors
Whereas: Dr. Robert G. Merrifield has been a member of the Southern Association of Agricultural Experiment Station Directors since 1977; and
Whereas: Dr. Merrifield has served with distinction as Chairman and Treasurer of the Association; and
Whereas: Dr. Merrifield has served as Chairman of the Association’s Strategic Planning Committee; and
Whereas: Dr. Merrifield has represented the Association as a member of ESCOP and as Chairman of the ESCOP Legislative Committee during the development of the 1995 Farm Bill and as a member of the USDA Joint Council on Food and Agricultural Sciences; and
Whereas: Dr. Merrifield has provided leadership and service in innumerable ad-hoc committees of the Association over his years as a member; and
Whereas: In all these areas of leadership and service at both national and regional levels Dr. Merrifield has given selflessly of his time and energy and has performed in an outstanding manner;
Now Therefore Be It Resolved That:
The Southern Association of Agricultural Experiment Station Directors expresses it’s sincere appreciation and thanks for Dr. Robert G. Merrifield’s contributions and wishes him and his family all success and happiness in their future endeavors.
Adopted At the Meeting of The Association in Orlando, FloridaNovember 14, 1995.
Tom J. Helms, Chair
Meeting of The Southern Association of AgriculturalExperiment Station DirectorsWalt Disney World Dolphin Hotel - Oceanic VOrlando, FLTuesday November 14, 19951. 3:15 Convene, Review, Modify, and Approve Agenda. Dr. Jerry Arkin
2. 3:20 Review and approval of Minutes of Previous Meeting and Interim Actions of Chair. Dr. Jerry Arkin
3. 3:25 USDA Implementation of the Government Performance and Results ActDrs. Jerry Arkin and George Cooper
4. 3:40 Roles and Responsibilities of the SAAESD in the Regional Listening Sessions for the Board on Agriculture Futuring Activities. Dr. James Fischer
5. 4:00 Workshop on Good Laboratory Practices. Dr. Charley Scifres
6. 4:15 SERA-Task Force on Sustainable Agriculture and Agroecosystems. Dr. James Fischer
7. 4:25 SRRC and Committee of Nine Report. Drs. Ike Sewell and D. C. Coston
8. 4:35 CSREES Report. Dr. George Cooper
9. 4:40 Changing of the Guard. Drs. Jerry Arkin and Tom Helms
10. 4:45 Annual Plan for the SAAESD. Dr. Tom Helms
11. 5:00 Preparations for the Mid-Term Update of the SAAESD Strategic Research Plan. Dr. Richard Jones
12. 5:20 Streamlining SAAESD Functions: Review at the February Meeting. Dr. Jerry Arkin
13. 5:40 SMIS: Proposed Poster Session for February Meeting. Dr. Neville Clarke
14. 5:50 New and Continuing Activities: Preparation and Review. Dr. Neville Clarke
15. IPM Grants Update. Dr. Larry Crowder
16. ARS Report. Dr. Charles Onstad
17. 5:55 Report on Resolutions. Dr. Neville Clarke