1. Beyond the Farm Gate: Channeling & Identity Preservation Indiana Ag Summit Indianapolis, Indiana 13. September 2002 Dirk E. Maier Extension Agricultural Engineer Post-Harvest Education & Research Center Purdue University www.GrainQuality.org

2. Current Quality Grain Dilemma Avoidance of transgenic characteristics vs. Promotion of special end use characteristics

3. 3 rd Wave Transgenic Crops Concerns National Academy of Sciences states that “the current APHIS review process will need to improve to deal with the risks of future modified crops … engineered to produce substances for non-food uses, such as pharmaceutical products, industrial chemicals, or fuel”. Source: http://pewagbiotech.org/buzz/display.php3?StoryID=52http://pewagbiotech.org/buzz/display.php3?StoryID=52

4. Federal Regulations Needed for 3 rd Wave Transgenic Crops Tolerance levels based on detectable thresholds allowable residue limits of pharmaceutical and industrial compounds in grains & oilseeds for food & feed EPA’s pesticide residue limits; FDA’s mycotoxins limits Testing technology with the commercial release of every new genetic event reliable and inexpensive strip test kits for elevator use meet customer demands presence of approved but undesired GM-crop traits

5. Federal Regulations Needed for 3 rd Wave Transgenic Crops FDA food safety requirements must be met trace contamination of non-target crops is NOT avoidable no IP system can contain 100% of every seed kernel, plant pollen and grain kernel active ingredient could be highly concentrated single kernel might exceed food safe exposure levels Federal oversight must be established & imposed mandatory process verification programs based on ISO and HACCP principles mandatory lead auditor training & certification federally licensed inspectors and auditors

6. Future Quality Grain Challenge Assure Quality and retain Economies of Scale Efficiencies of Operation

7. Quality Determination Product Verification at the first point of sale vs. Process Verification from field to end use

8. Quality Assured Grains Definition Grains & oilseeds that meet end user specifications with respect to a range of production and handling practices and pre-determined quality characteristics that are confirmed and documented from seed to final end use with a process verification approach to quality management.

9. Quality Management Systems Drivers Biotechnology Value added plant & animal products can only be captured with process control and traceability Affluent consumers Environmental & societal values affect purchasing decisions Precision of analytical tools Near zero specifications due to measurement of parts per trillion & DNA molecules Faster adoption of new technologies Fewer people involved in production Loss of U.S. dominance in world food trade EU GM labeling law & market access Reduced margins for farm income Need to focus on gaining operational efficiencies & new markets Food safety & biosecurity Food processors, manufacturers and retailers want tracking systems

10. Quality Management Systems Approach ISO standards promote the adoption of a process approach when developing, implementing and improving the effectiveness of a quality management system in order to enhance customer satisfaction by meeting (or exceeding) customer requirements.

11. Process-based Quality Management System Approach for Grain Production If ISO 9000 series is applied to grain production it must … help firms to standardize the terminology, language and process for their customized QMS address end use quality, identity preservation (genetic purity) and food safety of grains and oilseeds provide a certification protocol that facilitates trade and third party audits

12. ISO QMS Challenges ISO 9000 series is a disciplined thought process agriculture has not been strong in documentation common AG9000 approach integrating quality grain, food safety and IP handling principles most useful but very challenging Certification imposes documentation on a low- margin business difficult & expensive paradigm shift Will we have the courage to assume that a Standard is a good thing? delayed process of positioning among competing interests will eventually led to the same – a standard

13. The Need for AG9000 Now… Lead the establishment of a recognized world standard for agricultural grain production If we don’t do it, someone else will do it for us! Uniformity standards improve trade not hinder it trade disputes resolved based on standardized process & measurement methods Competitive opportunities are maintained customized QMS with internal documentation & quality plans QMS certification may be the key to preventing top down control of high-value grain production differentiated product delivery vs bulk commodity supply Discovery of unrealized production efficiencies & new markets Confirmation to consumers of process & quality of food

14. Our Goal: A quality grain management system must be based on least cost and most efficient best agricultural practices that result in consistent quantities of quality-assured grains and oilseeds to maximize the margins of producers, handlers and processors.