IFT Comments to USDA FSIS on Product Tracing related to E. coli 0157:H7

April 13, 2010

RE: Docket Number FSIS-2010-0008

To Whom it May Concern:

IFT, the Society for Food Science and Technology, appreciates the opportunity to comment on Docket No. FSIS-2010-0008, on tracing to identify source materials used to produce E. coli O157:H7-contaminated products and to identify products derived from those materials. Founded in 1939, IFT is a nonprofit scientific society with more than 18,000 members working in food science, food technology, and related professions in industry, academia, and government. IFT's long-range vision is to ensure a safe and abundant food supply contributing to healthier people everywhere.

The Institute of Food Technologists (IFT), under contract with the U.S. Food and Drug Administration (FDA) Center for Food Safety and Applied Nutrition (CFSAN), convened a panel of diverse experts to examine available technologies and current product tracing practices in food and other industries. In November, 2009, IFT released a technical research report that provides recommendations for improved product tracing, which is freely available at www.ift.org/traceability. IFT also submitted comments in response to the questions posed by FDA and USDA FSIS in a March, 2010, call for comments, and will again draw from our product tracing reports to FDA to present comments to FSIS on tracing to identify source materials used to produce E. coli O157:H7-contaminated products and to identify products derived from those materials.

IFT believes accurate tracing will play an integral role in helping FSIS achieve its’ mission of ensuring that the nation's commercial supply of meat, poultry, and egg products is safe, wholesome, and correctly labeled and packaged. Traceability of products is critical at all levels of the food system to protect public health by isolating products early to help contain a food incident. Additionally, product tracing can help contribute to the safety of the food system by identifying the cause of a problem, so that preventive controls can be put in place. Specifically, IFT recommends the following as best practices for effective product tracing:

Record Keeping
Each facility handling a product must record key data elements, such as lot numbers, dates/times, etc., for each Critical Tracking Event (CTE). CTEs are those instances when product is moved between premises, is transformed, or is determined to be a point where data capture is necessary for effective tracing. Records of these elements allow product linkages to be maintained throughout the supply chain. Accurate internal product tracing must also be maintained by all supply chain partners, including point of service. For products that do not undergo further processing or transformation (e.g., the case is not opened) a one-to-one relationship between incoming and outgoing lots must be maintained, even when repacking occurs. Maintaining the correct information elements is essential to product tracing, whether records are kept in paper or electronic format. The way in which each firm captures and records data internally should not be prescribed. However, for product tracing to occur rapidly, each entity must provide key data elements for CTEs to the appropriate agency within 24 hours of a request, in an electronic format.

Data in Electronic Format
Timely communication of requested information is best facilitated by data in an electronic format. The transfer of data to an electronic format should be required for all operations that are currently paper-based. For firms that lack the resources to convert their operations from paper-based systems, data transfer may be done by third parties, but must be done regularly and kept current.

Approved Standardized Formats
For each key data element, a limited, select set of standard nomenclature must be identified. Any progress made toward identifying and specifying content standards for product tracing will benefit all record keepers. IFT believes that current or newly developed standards for the content and format of electronic systems have practical utility for companies who continue to use paper-based records, as human-readable data that supports standardized electronic data can be useful.

Required Audit
The ability to trace product should be part of any standard third party audit. Appropriate identification of CTEs, adherence to one-to-one internal product tracing, and correct capture of key data elements should be included as part of audit procedures.

Guidance should be developed to detail the identification of CTEs and define relevant terms such as “lot”. Educational modules on product tracing compliance should be developed, and all segments of the food industry and regulatory community should be trained in their use.

IFT believes that setting clear objectives for those in the food supply chain, and leveraging existing industry systems to meet those objectives, is the most appropriate approach to effective product tracing. Any product tracing system implemented should be simple, user friendly, and globally accepted. IFT’s Core Recommendations on product tracing are that:

1. Standardized expressions of key data elements should be agreed upon.
2. Education on Critical Tracking Events (CTE) and key data elements should be developed.
3. Evidence of appropriate implementation should be part of standard audits.
4. Each supply chain partner must:

  • Identify CTE in order to trace product.
    Record standardized key data elements for each CTE that link incoming with outgoing product, whether product is transformed (internal tracing) or changes location (external tracing).
    Provide appropriate agency with relevant key data elements for each CTE, in an electronic format and within 24 hours of any request.

Many of the best practices and recommendations determined by IFT can be applied by FSIS for effective tracing of source materials used to produce E. coli O157:H7- contaminated products and to identify products derived from those materials. Efficient recordkeeping of information in approved standardized formats will assist Enforcement Investigations and Analysis Officers (EIAOs), Public Health Veterinarians, and District Office Personnel who conduct product tracing after tests indicate a presumptive positive. Easily accessible electronic records will also make it easier to manage information necessary to a trace-back, and may ease the amount of time personnel must spend in implicated facility(ies). Sharing of electronic records will also allow for faster upload to FSIS’ Administrative Enforcement Reporting System and will allow for improved communication between EIAOs and District Office Personnel. Electronic records with standardized expression of key data elements kept by the entire supply chain will lessen the amount of time needed to identify affected and potential suppliers, allowing FSIS to more rapidly protect public health overall.

Ideally, if product tracing requirements are to be set, they should extend to all products regulated by USDA FSIS. Both raw and RTE, intact or non-intact products should be considered priority, including heat-treated, not fully cooked products. Phased deployment of requirements could be based on risk. Not all hazards are microbiological in nature and therefore tracing source ingredients is just as important as tracing processed products. If based on risk, criteria such as previous association with human illness, as well as likelihood to be commingled or combined should be used to determine risk. Thank you for the opportunity to provide comments on product tracing efforts related to E. coli O157:H7. Please contact Jennifer McEntire, Research Scientist and Manager, Science and Technology Projects, if IFT may provide further assistance. She can be reached at 1025 Connecticut Avenue, NW, Suite 503, Washington, DC 20036; telephone number: 202-330-4984; or email address: jcmcentire@ift.org



Marianne Gillette
IFT President

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