FDA - Issues and questions

Here is the final excerpt from the FDA's notice about upcoming traceability meetings. This excerpt from the document talks about "issues and questions" about produce traceability, and the questions are big ones; do we need a produce identifier?; should all produce be covered?; should produce be co-mingled?


1. Issues and Questions for Discussion
As previously noted, we need to increase the speed and accuracy of traceback investigations to help limit the public health impact of a foodborne illness outbreak; to limit to a particular region, locality, farm(s), or processor(s) the source of the problem (where the source is in fact limited), so that an entire industry is not unnecessarily affected; to enable public health authorities and the food industry to provide targeted and accurate information about affected food to consumers; to institute steps to correct the source of contamination; and, as a result, to restore or enhance consumer confidence in produce safety. We intend the public meetings to stimulate and focus a discussion about mechanisms to enhance product tracing systems for fresh produce and to improve FDA's ability to use the information in such systems to identify the source of contamination associated with fresh produce-related outbreaks of foodbome illness. This discussion will help FDA determine what short and long term steps, such as issuing regulations, we should take to enhance the current tracing system. Aspects of these measures could require new legal authority. We welcome public comments and/or data on the following issues related to product tracing systems for fresh produce:
1. Should a "fresh produce identifier" be assigned to fresh produce? If so, at what stage or stages in the supply chain should such an identifier be assigned or modified? What data or information would be useful to include in such an identifier? Should the identifier be placed on the fresh produce, the package, the shipping container, and/or the invoice or bill of lading?
Should the location of the identifier depend on the type of produce or on other factors?
Our investigations of the 2006 outbreak associated with packaged fresh spinach and the 2007 outbreak associated with peanut butter were greatly facilitated by a product "code" that the party who packaged the implicated product had assigned to the packaged product. We seek comment on whether a "fresh produce identifier" should be assigned to fresh produce, and, if so, at what stage or stages in the supply chain and with what information elements.
2. What other data or information would be useful on the invoice or bill of lading, fresh produce, package, or shipping case? At what stage or stages in the supply chain should such data or information be included? The product "codes" assigned to the packaged fresh spinach associated with the 2006 outbreak and to the peanut butter associated with the 2007 outbreak were present on the packaged products. We seek comment on whether any other data or information (in addition to or instead of the fresh produce identifier discussed in question 1) should be on or attached to the invoice, bill of lading, fresh produce, its package (when feasible), or the shipping case.
3. Should an enhanced product tracing system extend to all fresh produce? Ifnot, what criteria should be used to determine coverage? There are a number of factors that may increase or decrease the risk for contamination of produce. Such factors may include crop characteristics (e.g., proximity of the edible portion of the crop to the soil, or rough surface, such as cantaloupe); production practices or conditions (e.g., water quality for field and packing operations); method of irrigation; likelihood of animal intrusion; and worker health and hygiene. Should these or other factors (e.g., history of outbreaks) be considered in prioritizing the development and application of an enhanced product tracing system?
4. Should fresh produce be commingled? If commingling is unavoidable, what practices should an enhanced product tracing system include to ensure that fresh produce can be traced effectively and efficiently? Some industry food safety guidelines advise against commingling (Ref. 8). Should parties in the supply chain for some or all commodities consider refining or designing their product tracing systems so that they can identify the source of individual pieces of fresh produce if they combine or commingle produce from multiple sources and link this information to the one-up/one down records they establish and maintain? If such identification is not feasible, should parties in the supply chain for some or all commodities consider no longer combining or commingling produce? We seek comment on any measures already in place to address product tracing of commingled fresh produce and the extent to which such measures have been demonstrated to be successful in ensuring product tracing, particularly during traceback investigations.
5. What should be the scope of an enhanced product tracing system for fresh produce?
As stated previously, the supply chain for fresh produce is often complex. We seek comment concerning how an enhanced product tracing system for fresh produce should apply to various parties in the supply chain, including producers, packers, distributors, and retailers. More specifically, we seek comment on whether some or all aspects of an enhanced product tracing system for fresh produce should apply to some or all farms. For example, if a fresh produce identifier includes information about the date of harvest, the farm is the party who would have that information. It may be more practical for the farm to identify the date of harvest on the invoice when it ships the fresh produce than for the first party in the supply chain to subsequently contact the farm to determine the date of harvest. We also seek comment on whether some or all aspects of an enhanced product tracing system for fresh produce should apply to some or all restaurants or retailers. For example, if a "fresh produce identifier" is assigned to produce a restaurant receives, we seek comment on whether the restaurant could establish and maintain records of that identifier or could retain the invoice or bill of lading if the information is contained on those documents. We also seek comment on whether some or all aspects of an enhanced product tracing system for fresh produce should extend to consumers. Product tracing systems currently used by the fresh produce industry typically do not reach the consumer level. However, some segments of the supply chain can and do record some individual consumer information, and may be able to use this information to alert specific consumers about product recalls or for other purposes. For example, a retailer who has a "frequent customer" or "bonus card" program may record each cardholder's purchases. The retailer's consumer purchasing information also would be very helpful in those situations where the fresh produce that is possibly linked to a foodborne illness outbreak is eaten and the consumers have disposed of any identifiers on the fresh produce before a traceback investigation begins. Could such systems be adapted or modified to provide assistance with traceback investigations? Would there be any issues or concerns associated with such systems?
6. Should the data or information in an enhanced product tracing system be human-readable, technology-based, or both? If technology-based, what technology should be used?
"Human-readable" information should enable all parties in the supply chain, regardless of the technology used, to read this information. By "human readable," we mean information consisting of numbers and/or letters capable of being read by the human eye. Technology-based systems could make it faster and easier to accurately record information such as a fresh produce identifier. For example, a person making a paper record of a human-readable identifier expressed in numbers or letters may mistakenly transpose or omit nUIIlbers or letters, thus creating erroneous entries in the records. In contrast, the potential for such mistakes is greatly reduced ifthe identifier is recorded using an automatic system such as a bar code or RFID. In addition, technology-based systems could greatly speed a traceback investigation. However, some parties may not have access to electronic technologies. We seek comment on whether data or information in an enhanced product tracing system should be human readable, technology-based, or both. If technology-based, what technology should be used?
7. What (if any) data or information in an enhanced product tracing system should be standardized? The lack of standardization in the information in current product tracing systems can frustrate traceback investigations. We seek comment on whether the various segments of the fresh produce industry should develop standards for the content and format of records, particularly of electronic records that could help make electronic record systems interoperable. We seek comment on the existence and utility of existing standards relevant to some or all of the information elements that would be in an enhanced product tracing system, such as in a fresh produce identifier. We also seek comment on whether such standards should be developed and on whether current or newly developed standards should be identified in any guidance or regulations issued by FDA. We also seek comment on whether and how current or newly developed standards for the content and format of electronic systems could have practical utility for parties who continue to use paper-based technology. For example, could human-readable data that support standardized technology-based data be useful to parties who continue to use paper-based technology?
8. What are the costs, benefits, and feasibility of implementing an enhanced product tracing system? Further enhancing the product tracing system for fresh produce could aid us in shortening the duration of outbreaks and limiting the number of people who become ill. It could also give us more information to use in preventing future outbreaks. However, these benefits will not come equally from all types of fresh produce. Enhancing the product tracing system beyond current practices and requirements for certain types of fresh produce might not significantly enhance public health if the fresh produce has not been associated with foodborne illness or any known risk factors. An enhanced fresh product tracing system for fresh produce may also impose burdens on entities in the supply chain. We seek comment on the costs, benefits, and feasibility of implementing an enhanced product tracing system for each of the parties in the supply chain. We recognize that enhancing product tracing of fresh produce may not be just a matter of keeping more or different records or adding more information to product or packaging, but also of changing business practices. We request comment on the extent to which an enhanced product tracing system for fresh produce will affect comingling and repacking of produce and the cost of any such changes in the supply chain.
9. Would enhancing FDA's role in developing and implementing effective product tracing systems for fresh produce, through increased regulation, guidance, or additional legal authorities, improve the effectiveness of traceback investigations and traceforward operations? What mandatory and voluntary measures would be most effective in achieving the goal of enhancing product tracing systems for fresh produce and improving FDA's ability to use the information in such systems to identify the source of contamination associated with fresh produce-related outbreaks of foodbome illness? How would these measures help FDA work better with industry and other stakeholders during traceback investigations and traceforward operations?