March 7, 2003

CFSAN has re-engineered its system for managing forms submitted in response to the Low Acid Canned Food Process (LACF) and Acidified Foods (AF) registration and process filing requirements. The process modifications are taking place in two key phases. Phase I, which was completed in February, included migration of current LACF and AF data from the previous system to the CFSAN Wide Area Network. CFSAN Field staff can now access LACF information through the Intranet. Phase II, already underway, includes the development of a Web-based component to permit direct entry of information by the filer.

This new system enhances FDA staff members' ability to view registered information. It also includes a Web-based as well as an MS Word version of the User's Guide, which is available from the LACF Main Log-in Screen and within the LACF Main Menu. The user has the ability to view or print the document.

The old NIH Titan System is no longer available. If Field staff log into the NIH system, there is a page identifying the discontinuance of the NIH LACF System. While CFSAN does not anticipate any problems, NIH user accounts under the old system will be retained for a short period of time for backup purposes.

Direct web-based registration data entry will be available once Phase II is completed, later in 2003. The direct entry will make essential process information, submitted by the filer, more readily available to Agency users both at Headquarters and in the Field. This enhancement will speed the filing process and will have data quality checks performed during the online filing process. These improvements in the ability to receive, review, and manage the forms will reduce the cost of operations, facilitate access to critical filing data by Agency staff, and provide a computer interface between FDA and filing firms. In addition, for entry reviewers we are in the process of making available LACF Views within the OASIS application. It is scheduled to be in the OASIS 5.2 release which is expected to be in June.

Following the completion of Phases I and II, FDA plans to develop online analysis capabilities, for use by CFSAN staff, to review process filings. Query and report generating functions are being developed to assist CFSAN staff. The capability to electronically notify firms of data errors or deficiencies will also be incorporated. These (and other) enhancements will assist CFSAN staff in process review and management of the LACF/AF filing process.

In March of 2000, FDA initiated a 1,000-sample survey focused on high volume domestic fresh produce (the Domestic Produce 1,000 Sample Survey). Cantaloupe, celery, cilantro, loose-leaf lettuce, parsley, scallions (green onions), strawberries, and tomatoes were collected and analyzed for Salmonella, and E. coli O157:H7. In addition, cantaloupe, celery, parsley, scallions, and tomatoes were also analyzed for Shigella. This survey was the domestic complement to the FY 1999 Imported Produce Survey (http://www.cfsan.fda.gov/~dms/prodsur6.html).

The objectives of the domestic produce survey were to:

• Collect and analyze samples of domestic fresh produce to determine the incidence of microbial contamination on these commodities

• Undertake appropriate regulatory follow-up if violative samples were found, to protect U.S. consumers and encourage firms to implement practices to minimize microbial contamination on fresh produce

• Obtain data to focus future research, risk assessment, industry training and food safety policy for the purpose of reducing foodborne illnesses resulting from contaminated fresh produce

Of 1,028 domestic samples that were collected and analyzed, 99% were not contaminated with Shigella, Salmonella, and/or E. coli O157:H7. Eleven samples (1% of the total number sampled) were contaminated with either Shigella or Salmonella; while 0% of the produce items were contaminated with E. coli O157:H7. Of the 11 contaminated samples, six (55%) were contaminated with Salmonella and 5 (45%) were contaminated with Shigella.

For regulatory follow-up, domestic samples that were found to be violative were reported to the collecting district and CFSAN's Case Processing Contact. Violative domestic produce could either be reconditioned or destroyed. Firms with violative produce were encouraged to conduct voluntary recalls. Follow-up investigations were conducted at three violative farms to determine potential sources of contamination.

The complete report on the sample survey and its results can be found on FDA's web site at http://www.cfsan.fda.gov/~dms/prodsu10.html.