IFT, the Society for Food Science and Technology, appreciates the opportunity to comment on Docket No. FDA-2009-N-0523, related to product tracing in food systems.
RE Docket No. FDA-2009-N-0523
To Whom it May Concern:
IFT, the Society for Food Science and Technology, appreciates the opportunity to comment on Docket No. FDA-2009-N-0523, related to product tracing in food systems. Founded in 1939, IFT is a not-for-profit professional scientific society with over 18,000 members from industry, academia and government whose mission is to advance the science of food. IFT's long-range vision is to ensure a safe and abundant food supply contributing to healthier people everywhere.
In November, 2009, IFT released a technical research report that was commissioned by the US Food and Drug Administration’s Center for Food Safety and Applied Nutrition. Our responses to the questions posed by FDA and USDA FSIS in the Federal Register notice draw from that report, which is freely available at www.ift.org/traceability. Additionally, IFT sought member input on issues that were not addressed in the report.
IFT responses appear in italics below each question presented in the Federal Register notice.
A. Core Information Elements of a Product Tracing System
1. Lot Code or Number (or Other Identifier of the Food)
Question 1a. Should a lot or code number (or other identifier of the food) be assigned to food? If so, at what stage or stages in the supply chain should it be assigned or modified? For example, should a lot or code number (or other identifier of the food) be assigned for all finished food products, whether sold in packaged or unpackaged form? Should a lot or code number (or other identifier of the food) be assigned whenever food is manipulated (such as when fresh produce is commingled, packed, or repacked)?
IFT believes a lot or code number should be assigned to all finished food products, whether sold in packaged or unpackaged form (with the exception of foods that are prepared onsite for immediate consumption). Similarly, all food ingredients should be assigned lot numbers. A new lot number should be assigned whenever food products or ingredients are manipulated (such as commingling, repacking, etc.) If a lot number is changed, it is critical that the previous constituent lot numbers are recorded and maintained and are able to be linked to the new lot numbers.
Question 1b. What data or information would be useful to include in a lot or code number (or other identifier of the food)?
Firms should be able to decide if they want to include data or other information within their lot number, and should be able to decide the format and schema of their lot code number. Some firms define the lot code as a “sell by” or “best by” date; for others, the code is random. Ideally, this would become standardized eventually. These lot codes should be unique and not be able to be reproduced during the foreseeable shelf life of the ingredient or product. While a lot code is useful in distinguishing product, IFT believes there are several key data elements that should be conveyed (on paperwork/transactions related to the product as well as case labels), such as location of production, manufacturing, receiving and/or shipping dates, etc. as outlined in our report. The lot number should be associated with these data elements as well.
Question 1c. What (if any) procedures should be used to establish a lot or code number (or other identifier of the food)? Should any such procedures address the size of a lot or the time frame for production of a lot (e.g., 21 CFR 113.60(c) provides that codes may be changed on the basis of one of the following: Intervals of 4 to 5 hours; personnel shift changes; or batches, as long as the containers that constitute the batch do not extend over a period of more than one personnel shift)?
The size or quantity of a lot represents the amount of financial risk a firm is willing to incur if a product needs to be withdrawn or recalled. The IFT report recommends that firms be allowed to determine the size of a lot, but urges firms to limit a “lot” to 24 hours worth of production or less. In manufactured food products, maximal control of risk would occur if a lot code changed when any ingredient lot changed. This would maintain ideal internal traceability. The size of a lot also determines the number of samples that need to be taken for a valid sampling plan. b. Location of a lot code or number (or other identifier of the food).
Question 1d. Should the location of a lot or code number (or other identifier of the food) depend on the type of food, other factors, or both?
See below. The location of a lot number may be dependent on the nature of the food product and packaging material.
Question 1e. Should a lot or code number (or other identifier of the food) be located: On the label (or container or package) of a packaged food?
If the food is presented in a form that bears a label, or is in a package or container, the lot code should appear. Exclusions for size, such as exist for nutrition labeling, should be considered. For example, small individually-wrapped foods not for resale should not need a lot number, although the larger container should bear a lot number.
On the shipping container of packaged food, unpackaged food, or both?
Yes, the lot number should appear on the smallest shipping unit (e.g. case) for both packaged and unpackaged products.
In internal records (such as receiving records, batch production records, inventory records, and distribution lists)?
In external records accompanying commercial transactions (such as a bill of lading, airway bill, invoice, manifest, shipping record, or packing list)?
Yes, external records should bear a lot or code number, although firms should be able to determine what external records will bear the lot information. Lot numbers should be communicated to trading partners in such a way that the recipient of the physical product receives record of the lot numbers (which should match those on the shipping containers) and any other parties that are part of the transaction (e.g., broker, sales office, etc.) receive lot information. Lot code information should be printed and displayed on any paperwork relating to the production, sale or movement of product throughout the supply chain.
Question 1f. What ways might the lot or code number (or other identifier of the food) be linked to internal and external records associated with the food?
Additional information should be related to the lot code (e.g., in a database) so that the link between the lot code and particular food can be made. These data elements might include shipped/received dates, shipped/received address, etc. Incoming lot numbers must be linked to outgoing lot numbers, whether a food undergoes processing/transformation or not. The medium that links the lot number with the record (e.g., barcode) should be determined by the firm.
2. Information Elements Not Already Required in 21 CFR Part 1, Subpart J
Records accompanying commercial transactions or documenting delivery or receipt of a product in commerce (such as a bill of lading, airway bill, invoice, shipping/receiving record, and packing list) contain product tracing information. For example, such records identify who is sending a product forward in the supply chain, who is receiving the product, what the product is, and how much of the product there is. In some cases, such records also identify the lot or code number (or other identifier of the food). Many of these records have their own identifier, e.g., an invoice number, airway bill number, or a bill of lading number. It may be efficient to associate product tracing information with a ``shipment identifier,'' such as an invoice number, airway bill number, bill of lading, or some other identifier established by the shipper. For example, a firm that is sending product forward in the supply chain may retain some information (such as a lot or code number or other identifier of the food) in an internal inventory record and other information (such as the immediate subsequent recipient of the product) in shipping and distribution records. Including the shipment identifier in all of these records may help to link the records, particularly when records are in electronic form and can be searched using electronic means.
Question 2a. Should a shipment identifier be considered an information element of an enhanced product tracing system? If so, are there any business practices (e.g. the way shipments are currently identified) that would be impacted?
A shipment identifier could be an information element, however, IFT believes that if lot numbers are properly communicated and recorded, a shipment identifier would serve as a redundant, and likely less specific, link. Many types of products and lots would expect to be associated with one shipment identifier. In the present day, where lots are not consistently communicated, we agree that a shipment identifier is a useful link. However, IFT would urge the Agency to require lot code information to be communicated, which would make a shipment identifier unnecessary for tracing purposes. The shipment identifier has the potential to serve a “primary key” if data are shared electronically between trading partners, with lot code specific information for a variety of products being associated with this “key”.
3. Information Elements on the Package of a Packaged Food and/or on the Shipping Case
Question 3a. Should product tracing information not currently required to be on the package of a packaged food or on a shipping case be present on the package or shipping case? Yes Question 3b. If so, what additional product tracing information should be present on the package or shipping case?
Shipping cases should contain lot numbers and the product name or identifier, and the name and location of the facility that manufactured the product. Name and location of co-manufacturers must be listed, rather than name of brand-owner and location of company headquarters.
Question 3c. If so, at what stage or stages in the supply chain should such information be included?
Each facility that creates or transforms the product, either through formulation, repacking, commingling, etc.(with the exception of establishments that transform or formulate products for immediate consumption by consumers) should be required to create, record, and transmit product tracing information as described above on the shipping case. Question 3d. If so, should such information be present for all food, or only some food? This information should be present for all foods with the exception of those produced for immediate consumption.
4. Information Elements Transmitted Beyond ``One Up/One Down''
Question 4a. Should some information about fresh produce (such as information identifying the name and physical location of any farm, packer or repacker that provided, processed, or packed fresh produce) be sent forward farther in the supply chain than ``one down''? If so, how far in the supply chain should such information go? For example, should such information be transmitted as far as the retail establishment that sells the fresh produce to consumers, or as far as the last person in the supply chain before the retail establishment?
IFT does not believe it is necessary to transmit information beyond “one up/one down”. However, the information captured by each firm for each critical tracking event, as defined in the IFT report, should allow for the linkages through the product supply chain so that products, by linking lot numbers and other pertinent information, should be able to be traced through the supply chain.
Since many cases of fresh produce do bear a grower/shipper/packer name, firms should be prohibited from shipping fresh produce in cases that bear a name other than one of the supply chain handlers (whether the originator, repacker, processor, etc.). In other words, to avoid confusion, firms should not be able to put fresh produce (or any other product, for that matter) in a shipping container that would imply a source or handler that had no actual relationship to the product.
Question 4b. Should some information about packaged food (such as information identifying the manufacturer of a processed food) be sent forward farther in the supply chain than ``one down''? If so, how far in the supply chain should such information go? For example, should such information be transmitted as far as the retail establishment that sells the food to consumers, or as far as the last person in the supply chain before the retail establishment?
No, IFT does not believe it is necessary to transmit information beyond “one up/one down”. IFT does believe that “one up/one down” information should be captured throughout the supply chain, including by the retail establishment that sells the food to consumers.
5. Standardized Information Elements The lack of standardization in the information in current product tracing systems can delay traceback investigations and traceforward operations largely due to the need to interpret and clarify information elements between varying product tracing systems and the lack of systems to link information elements.
Question 5a. What (if any) information elements in an enhanced product tracing system should be standardized? Are there specific information elements (such as a shipment identifier and a lot or code number (or other identifier of the food)) that are particularly amenable to standardization? Would such standardization be specific to a specific industry sector or type of food (e.g., fresh produce, frozen seafood, milk, baked goods, breakfast cereal) or could it apply across industry sectors or types of food?
Information elements in an enhanced product tracing system should be standardized to the extent possible, recognizing that this will require global cooperation. Some standards, such as the format to communicate date and time, should be universally applied, regardless of industry sector or type of food. Although global standardization of all information elements is ideal, other types of standards, such as location, may be easier to implement if they are specific to an industry sector. This is due to the fact that some industries already have facility identifiers in widespread use, either due to regulation or industry practice. In studying the variety of formats that are used to convey lot code information, IFT feels that a standard lot code format will be one of the more difficult information elements to implement at the present time, although industry(ies) should be encouraged to try to harmonize lot code formats. Other, less specific product identifiers, do exist in standardized form and are in widespread use in some industries. The GS1 Global Trade Item Number (GTIN) has been used by the packaged foods industries for decades and is currently being adopted by the produce industry as part of the Produce Traceability Initiative.
Question 5b. What standards already exist and how useful are they for product tracing?
Many standards already exist. One might argue that too many options for standards exist. The IFT report “Traceability (Product Tracing) in Food Systems” describes many of these standards, including those for location, time, product identification, and others, that are in use around the world in various sectors. These standards could be very useful if they were consistently used throughout the global supply chain.
Question 5c. If standards can and should be used for certain information elements in an enhanced product tracing system, should FDA develop the standards?
No, FDA should not prescribe the standards to be used, but should require that some set of standards be selected by industry. However, the FDA can play an important role by providing industry with suggestions of available standards, and require industry to adopt a specified number of standards (within a certain timeframe for implementation), but IFT feels that industry will be able to select appropriate standards. It is also important to consider that the food supply is global, and the development of new standards, or application of existing standards, should be determined considering the global nature and acceptance of the standard system.
Question 5d. Would current or newly developed standards for the content and format of electronic systems have practical utility for persons who continue to use paper-based records? For example, could human-readable data that supports standardized electronic data be useful to persons who continue to use paper-based records?
Yes. Whether records are kept in paper or electronic format is a separate issue from keeping the correct information elements. Any progress made toward identifying and specifying the content standards for product tracing will benefit all record keepers.
1. Record of the Lot or Control Number (or Other Identifier of the Food)
FDA's regulations in 21 CFR part 1, subpart J require persons who manufacture, process, or pack food to keep records on the lot or code number or other identifier of the food received from the nontransporter and transporter immediate previous sources of food, or released to the nontransporter and transporter immediate subsequent recipients of food, to the extent this information exists (Sec. Sec. 1.337(a)(4) and 1.345(a)(4)). These regulations do not require persons who do not manufacture, process, or pack food to keep records on the lot or code number or other identifier of the food.
Question 6a. Would it be useful for persons, in addition to those who manufacture, process or pack food, to establish and maintain a record of a lot or code number (or other identifier of the food)? If so, for which persons (e.g., distributors, retailers) would it be useful?
It is critical that each supply chain member who physically produces or handles the product maintain a record of a lot or code number, including distributors or retailers. Additionally, other parties to the transaction (such as brokers) should also keep a record of the lot or code number.
Question 6b. If it would be useful for some persons, in addition to those who manufacture, process, or pack food, to establish and maintain a record of a lot or code number (or other identifier of the food), would it be equally useful irrespective of the type of food (e.g., packaged food or fresh produce)?
2. Records to Facilitate Linkage FDA's regulations in 21 CFR part 1, subpart J also require records kept by nontransporters to identify the immediate subsequent nontransporter and transporter recipients of food to include information reasonably available to the nontransporter to identify the specific source of each ingredient used to make every lot of finished product (Sec. 1.345(b)). In essence, a record containing such information is a ``linking record,'' because it links a specific lot of released food to specific lots of ingredient. FDA's regulations in 21 CFR part 1, subpart J have no corresponding requirement (under Sec. 1.337) for a ``linking record'' that would link a specific lot of an incoming ingredient to all released food containing that specific lot of ingredient.
Question 7a. Would it be useful for nontransporters who manufacture, process, or pack food to establish and retain any additional records to facilitate linkage? In particular, would it be useful for persons who manufacture, process, or pack food to establish and maintain a ``linking record'' that would link a specific lot of an incoming ingredient to all released food containing that specific lot of ingredient?
Yes – this concept of “internal traceability” is most critical in the initial stages of responding to a potential food safety event. These records may help investigators and industry alike in identifying ingredients potentially associated with a contamination event or foodborne illness outbreak. Without this level of internal traceability and specificity, the true etiology of food safety events can be very difficult to identify.
Question 7b. If so, should some or all of these records be created at the time of receipt or release of food or be existing records, or should some or all of these records be new records created upon the request of FDA (e.g., during an outbreak investigation or traceforward operation)?
These records should be created and maintained as part of the lot coding process. Food processors and manufacturers should create and maintain these records at the time the corresponding lot of finished product is being produced or manufactured. Production of these records during the time of a food safety event or investigation make it less likely that accurate data exist or were collected at the time the product was produced or manufactured. These records should be maintained for at least two years after the shelf life of the product and be available to FDA within 24 hours of request.
Question 7c. If so, would it be useful for FDA to specify the format of the record? For example, should FDA provide a model form that could be used to provide the information in such a record? Or would it be more useful for FDA only to specify the information elements of such a record?
It would be helpful for FDA to provide a model form to record product linkages; however, industry should not be required to use the form as long as the specific information elements of such a record are made available.
Question 7d. If so, should all such records be in electronic form?
Records requested by FDA should be provided in an electronic form. However, firms should not be required to establish or maintain these records electronically. Records that are not established in electronic form would need to be converted and maintained to electronic form so that information can be provided to FDA in 24 hours in an electronic form in the event of an official request.
3. Records That Are Both Electronic and Human-Readable
As noted (see section IV.E of this document), comments to the 2008 notice of meeting on product tracing for fresh produce recommend that information in a product tracing system should be human-readable. Human-readable information would enable all persons in the supply chain to have access to the information. These comments also recommend that information in a product tracing system should, where possible, be in electronic form. Electronic systems could make it faster and easier to accurately record information, such as a lot or code number (or other identifier of the food) and link incoming with outgoing product and thus speed the course of a traceback investigation or traceforward operation. For example, a person making a paper record of a human-readable code expressed in numbers or letters may mistakenly transpose or omit numbers or letters, thus creating erroneous entries in the records. In contrast, the potential for such mistakes would be greatly reduced if the code is recorded using an automatic system, such as a bar code or RFID.
However, some persons may not have access to electronic technologies, particularly if the technology (such as the use of bar codes or RFID) requires an initial investment. Some persons may be reluctant to select a particular electronic technology if there is no industry standard for which electronic technology to use.
Question 8. Should some or all product tracing records be established and maintained in electronic form? If so, should information established and maintained in electronic form also be human-readable?
IFT does not feel that product tracing records need to be established in electronic form, although this should be encouraged. Records that are not established in electronic form should be converted and maintained in electronic form so that information can be provided to FDA in 24 hours in an electronic form in the event of an official request. Information should be human readable.
4. Mechanisms to Make Product Tracing Information Available to FDA
Question 9a. What can be done to speed the process whereby persons who have product information relevant to a traceback investigation provide the information to FDA? For example, should some information be sent to FDA, rather than have FDA travel to a facility that has the information?
Firms should be able to send information to FDA, preferentially electronically to speed investigations.FDA should have a system whereby they can manage submitted information efficiently so that product linkages are more readily apparent.
Question 9b. If information would be sent to FDA, how should it be transmitted? For example, could the information be transmitted by e-mail, fax, or courier service (e.g., by overnight delivery)? Or should there be an electronic portal (such as the portal FDA developed for the Reportable Food Registry)?
Systems should be developed, similar to the reportable food registry, whereby firms can securely share electronic information with FDA upon request. However, a system like this will need to be regularly monitored for information accuracy. If electronic records are not mandated, or until a time when they are mandated, FDA should accept information via other means, such as email, fax, or courier service.
C. Role of Risk in Developing an Enhanced Product Tracing System
Question 10. Should any or all enhancements to current product tracing systems apply regardless of risk, or should such enhancements be based on risk? If based on risk, what criteria should be used to determine risk? If not based on risk, should such enhancements be developed or phased in based on risk?
The IFT report recommends a system that would be applied to all food products. Ideally these enhancements would occur industry wide with no exemptions based on food type or industry segment. It would be possible to phase in the requirements based on underlying risk in a product category, as long as the entire supply chain participated. If a phased deployment of these requirements is more feasible, focusing on foods and ingredients that are “Ready-to-Eat” (RTE) such as fresh produce, peanut butter, milk, spices, etc may offer the most significant protection in public health. However, given the complexity of the global food supply, novel ingredients (melamine) can present unforeseen risk to the consumer.
Additionally, within “high-risk” product categories, the firms that pose the greatest risk of causing an outbreak (contamination event) may be those that would require the greatest change to their operation and processes. The IFT reports recommend increased training and technical assistance to firms that would require the most changes (for example, small, limited size firms). Enhancements should not be phased in based on firm size, since weak links in the chain will make traceability impossible.
D. Costs, Benefits, and Feasibility of Implementing an Enhanced Product Tracing System
Further enhancing the product tracing system for food could aid FDA in shortening the duration of outbreaks and limiting the number of people who become ill. It could also give FDA more information to use in preventing future outbreaks. However, net public health benefits from enhancements to current product tracing systems may vary by food category depending on the level of risk. The net public health benefits may also vary by the type and size of entity along the supply chain that would be covered by the enhanced product tracing systems. FDA recognizes that enhancing product tracing for food may not be just a matter of keeping more or different records or adding more information to product or packaging, but also a matter of changing business practices.
Question 11a. What are the costs, benefits and feasibility of implementing an enhanced product tracing system for each of the persons in the supply chain for various segments of the food industry?
The types of costs and benefits expected from an enhanced product tracing system are described in the IFT report. Briefly, costs include capital investment and startup, software and associated fees, equipment, consultants, labor and training, materials and supplies, change in operations and procedures; benefits include improved supply chain management, inventory control, access to markets and contracts, and more targeted recalls (or the ability to exclude the firm from a recall).
Question 11b. To what extent would an enhanced product tracing system affect current business practices? What would be the cost of any such changes in current business practices for each link in the supply chain?
The extent of the cost of changes in current business practices will depend on the magnitude of change that the firm needs to make. The cost for firms that already keep records consisting of the generally recognized information elements will be less than the cost for firms that do not currently keep records. Whether or not firms will need to establish and/or maintain records will also have a major bearing on cost. For product cases or containers that do not currently bear needed information, the equipment required to add that information may necessitate a change to the flow of the product through a facility.
Question 11c. What determines the costs for food distributors and retailers to maintain records of lot code information for manufactured products, and farm-related information for fresh produce?
The types of costs and benefits expected from an enhanced product tracing system are described in the IFT report and summarized briefly in response to Question 11a The number of suppliers, and the fact that the distributors and retailers may not currently maintain these records now will influence cost. If maintaining records causes product to be moved through a facility more slowly, this delay will have economic consequences. For foods that require refrigeration or freezing, regardless of the recipient, delays resulting from the time it takes to obtain records (or the “wait” if there is a queue for receiving) could compromise food safety or quality.
Question 11d. What determines the costs for small food retailers to maintain records consistent with the BT regulations, as well as lot code information for manufactured and processed food products, and farm-related information for fresh produce?
The types of costs and benefits expected from an enhanced product tracing system are described in the IFT report and summarized briefly in response to Question 11a. If small food retailers maintain records using a paper-based system, they should be required to have available electronic transfer of data in response to a request from FDA. In this case, the firm would face the choice of moving to an electronic system or hiring a third party firm to convert the required information.
If proper records are maintained throughout the supply chain and lot code information is displayed on shipping cases and accompanying paperwork, then maintenance of this information for retailers may simply be a matter of keeping records for a specified period of time.
Question 11e. What determines the costs for food service establishments to maintain records consistent with the BT regulations, as well as lot code information for manufactured or processed food products and farm-related information for fresh produce?
Costs for food service establishments would likely be the same as for small food retailers, which was summarized in response to Question 11d above.
Question 11f. What determines the size of a lot of manufactured or processed food products and how do lot sizes vary by food category and size of the manufacturer?
Lot sizes are determined by the producing company, unless regulations dictate otherwise. Lot sizes may depend on whether a food is produced by a “batch” or a “continuous” process. When food is produced by the batch, the size of the batch (which depends on the size of the kettle, mixer, etc.) may constitute the size of a lot. When food is manufactured or processed under “continuous” operations, lot sizes are often defined as timeframes (e.g., 24 hours of production). Ideally, lot sizes would change when an ingredient lot used to manufacture the finished product changed.IFT recommends that a lot be limited to 24 hours worth of production, when practical.
Question 11g. What determines the costs for maintaining ``linking'' records for manufacturers?
Both the standardization of data elements and performance standards (24 hour reporting) would dictate costs associated with linking records for manufacturers. Internal product linking systems will vary depending on the size, scope and complexity of a process. The number of component ingredients will be associated with the costs for maintaining the linking records. All inputs required in the production process should need to be identified and linked to the final processed product.
Shortly after the establishment of the product tracing requirements in 21 CFR part 1, subpart J, FDA held a series of public meetings to provide information on the rule to the public and to provide the public an opportunity to ask questions of clarification (69 FR 71655, December 9, 2004). Regardless of such outreach, the HHS OIG report (Ref. 15) noted that manufacturers, processors, and packers do not always maintain lot-specific information, as required.
Question 12a. What, if any, additional outreach from FDA would better enable manufacturers, processors, and packers to comply with the requirements to maintain records of the lot or code number (or other identifier) to the extent this information exists?
FDA should develop tailored communication messages which should be shared through a variety of venues, and collaboration should be sought from a number of “multipliers”. For example, FDA inspectors at the local level should be provided with information to disseminate during inspections. FDA should seek to collaborate with other agencies, such as state and local public health departments or departments of agriculture, so that any official (whether with FDA or not) entering a food establishment (from farm to retail operation) could provide this information. Additionally, FDA should continue to work with trade associations and professional associations to disseminate messages broadly.
Outreach messages should be industry segment specific (particularly if the requirements vary by segment), should provide examples of compliance and lack of compliance, and should be available in a variety of languages.
Question 12b. What, if any, additional outreach from FDA would better enable all persons subject to 21 CFR part 1, subpart J to better comply with its requirements?
See response above.
FSIS is seeking comment on the following:
A. Core Information Elements of a Product Tracing System
2. Standardized Information Elements
Should FSIS focus on standardizing product codes?
Would current or newly developed standards for the content and format of electronic systems have practical utility for persons who continue to use paper-based records? For example, could human-readable data that supports standardized electronic data be useful to persons who continue to use paper-based records?
Yes. Whether records are kept in paper or electronic format is a separate issue from keeping the correct information elements. Any progress made toward identifying and specifying the content standards for product tracing will benefit all record keepers.
B. Role of Risk in Developing Regulations
Should any or all enhancements to product tracing systems apply regardless of risk, or should such enhancements be based on risk?
Ideally, traceability requirements would extend to all products regulated by FSIS. Phased deployment could be based on risk. Ground, blade-tenderized, low-temperature rendered product, and similar products would most immediately benefit from improved traceability.
[cir] If based on risk, what criteria should be used to determine risk?
Previous association with human illness as well as likelihood to be commingled or combined (especially ground or ammonia treated product).
[cir] If not based on risk, should enhancements to product tracing systems be developed or phased in based on risk?
Ideally, traceability requirements would extend to all products regulated by FSIS. Phased deployment could be based on risk.
The need for adequate ground beef grinding records is based on risk. Should FSIS wait for other specific items to become public health issues or should FSIS use a broader approach and include all amenable product?
Should FSIS be concerned about ready-to-eat product or focus on raw product?
Both raw and RTE should be considered priority products. Should FSIS look at heat-treated, not fully cooked products?
[cir] Does formulation impact heat-treated, not fully cooked products to the extent that FSIS needs to traceback the source material or should FSIS focus more on the processing practices and labeling?
Similar to other manufactured food products, risk can be associated with source material as well as processing. Not all hazards are microbiological in nature (melamine) and therefore tracing source ingredients is important.
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