FDA Recordkeeping Training Program

Charles Hurburgh, Faculty and Howard Shepherd, P&S - Center for Crop Utilization Research


The Public Health, Security, and Bioterrorism Preparedness and Response Act of 2002 gave Food and Drug Administration (FDA) the responsibility for tracing incidents of food adulteration  to its source, regardless whether the incident was caused by bio-terrorism or by natural causes. The Act mandated FDA to register facilities where raw agricultural commodities are received, stored, and delivered. The Act also gave FDA the authority to require recordkeeping for tracing raw agricultural commodities one step back to the previous source for grain received and one step forward to the next owner for grain shipping. The recordkeeping requirement began for companies with over 500 full time employees 9 December 2005 and will begin for companies with eleven to 499 full time employees on 9 June 2006. The Agribusiness Association of Iowa recognized that grain handling facilities across Iowa did not have a full understanding of the recordkeeping requirements.  As an addition to a developing IGQI web-based training project, AAI asked the Iowa Grain Quality Initiative for help in member training about FDA recordkeeping requirements.

IGQI will expand the IGQI web based interactive education tool on FDA recordkeeping to serve AAI member grain handling and feed mill facilities with one to 499 full time employees. This will assist Iowa agribusinesses meet the one step forward and one step backward standard of tracing grain received and shipped.

1. A training model for grain handling and feed mill facilities with less than 500 full time employees was development to assist them in meeting the 9 June 2006 deadline.
2. A news release was developed for the ISU Extension website to announce the FDA recordkeeping presentations at the AAI leadership conference in January 2006.
3. IGQI organized a session at the AAI Leadership conference on 11 January:
    a. Dave Myers FDA Des Moines office presentation on the FDA regulations
    b. Howard Shepherd IGQI presentation on grain handler and feed mill recordkeeping requirements of the FDA regulations
    c. Dr. Charles Hurburgh IGQI presentation or recordkeeping and traceability
4. The grain handler and feed mill recordkeeping model is posted on the IGQI website for access and training by Iowa agribusinesses.
5. A handout was created for AAI to distribute at their six district meetings.

The impact of the recordkeeping module is evolving, because while the basic requirement of the regulation is constant, compliance is not clearly understood. Grain handlers recognize the compliance deadline is 9 June 2006. They believe what they are doing now, essentially identifying all patrons of the elevator as possible contributors to any given shipment,  meets the intent of the law   This is not likely to be sustainable.  The recordkeeping training module developed by IGQI offers Iowa agribusiness an opportunity to view compliance requirements in a quality management system strategy, as part of an overall package of profit-generating operational improvements
1.  IGQI developed a closer working relationship with AAI.
    a. AAI invited IGQI to present recordkeeping requirements at AAI Leadership conference.
    b. AAI asked IGQI to develop a recordkeeping handout use at 6 district meetings.
    c. AAI has included IGQI website on their link page.
2. News release on ISU Extension website about recordkeeping requirements and the AAI conference generated two other news releases
    a. One by a Ft Dodge web news site
    b. One by an eastern Iowa coop news web site.
3. AAI announced through their Take Five and Regulatory Compliance news letters where to find the recordkeeping training module on the IGQI web site.
    a. These announcements resulted in 15 calls about the recordkeeping requirements.
4. ScoringSystem, Inc. picked up on the AAI news releases about the IGQI recordkeeping training module on its website.
    a. ScoringSystems, Inc. a food traceability company contacted IGQI, requesting authorization to recommend the IGQI website and recordkeeping training module in an electronic news release.
    b. They e-mailed the news release recommending IGQI website to 20,000 contacts on their mailing list about our training module.
    c. IGQI has received phone calls and e-mail responses for the recommendation.
5. IGQI participates in the Iowa Ag Coop Safety Manager Association and had presented information on the recordkeeping requirements for feed and grain.
    a. The discussions resulted in two contact calls about the record keeping requirements and a request to present an update to their grain handler management staff.
    b. A compliance consultant at the Association meeting e-mailed clients a news release about what IGQI discussed and recommended contacting IGQI with questions.
6.  IGQI meet with Heartland Coop in West Des Moines presenting and discussing the recordkeeping requirements and quality management strategies in grain and feed.
Plans for program
1. Develop a meeting with AAI, IDALS, FDA-region 7, and GEAPS to reviews recordkeeping requirement and further develop the IGQI recordkeeping training module into a state module.
2. Use the recordkeeping module as a steppingstone to an Iowa traceability model for raw agricultural commodities.
3. Incorporate IGQI modules in the nationwide GEAPS- Purdue web- training program.

April 14, 2006
123 - Grain Quality Initiative

Page last updated: July 9, 2006
Page maintained by Linda Schultz, lschultz@iastate.edu