Questions & Answers on Romaine Origin/Harvest Date Labeling
December 7, 2018
This questions and answer document has been created by PMA and United Fresh, with input from our association colleagues across the supply chain and based on member questions, using the information available from FDA (commissioner statement and update) and CDC as of December 7, 2018. As the use of these labels begin, we expect that additional questions will arise, and/or best practices might be adjusted as participants gain experience. We will update the current FAQ’s and make additions as we move forward. Please free to contact us with additional questions as appropriate.
1. What is Origin/Harvest Date labeling? The new voluntary label is designed to provide consumers with visibly positioned readily understandable information on where their romaine is grown and the approximate date on which it was harvested. For bagged product, this information would be printed on the consumer-level package. Commodity products that lack a label, and products that reach consumers through foodservice will use a different mechanism, based on labeling at the carton level, as described below.
2. What is the purpose of this new voluntary label? The FDA and CDC alerted consumers not to consume romaine on November 21, 2018. They also asked that romaine be removed from stores and restaurants. FDA had requested a voluntary withdrawal of all romaine in the supply chain, including inventory at shipping point or warehoused, with the assumption that product would be destroyed. This alert included all romaine no matter where it was grown or harvested. Since the earliest onset date, i.e. when consumers first became ill, is stated by FDA and CDC to be October 8, 2018, that means harvest would have taken place in early to mid-September and continued through the month. The growing areas that are scheduled to supply market needs today were not yet at harvest maturity, and therefore not being harvested in September or early October, so they could not possibly have supplied the romaine that is suspected of causing this outbreak. Therefore, this label is intended to help consumers know that the romaine they are seeing in a retail store or restaurant has been harvested subsequent to the outbreak and is from a region not implicated as a supply source involved in the outbreak.
3. What should the label say? The FDA does not specify terms of disclosure, but based on discussions prior to the issuance of the update, we suggest that the label for a consumer-level package, or case, as applicable should say: Romaine grown in (source) and harvested after (date). Some companies may elect to label with a “harvested on” date when that makes more sense for their operation (e.g., for field-packed romaine).
4. What products are covered by this label? This recommendation includes any and all products that use any form of romaine lettuce (including baby romaine and red romaine).
5. Does the labeling program apply to other leafy greens? At this time, the approach is limited to products containing all forms of romaine lettuce.
6. Is this a new regulation from FDA? No, the use of this label is not a new regulation. A new regulation would require FDA to go through a formal rule making process. The use of this new label is a voluntary. However, CDC is urging consumers to “Check bags or boxes of romaine lettuce for a label indicating where the lettuce was harvested.”. FDA states “Based on discussions with producers and distributors, romaine lettuce entering the market will now be labeled with a harvest location and a harvest date or labeled as being hydroponically- or greenhouse-grown. If it does not have this information, you should not eat or use it.”
7. Do we have to use the label? No, this is a voluntary effort. However, FDA and CDC are promoting to consumers that they should look for/ ask for this information when purchasing or eating romaine to ensure that the available romaine is not from regions that could be associated with the outbreak (Central Coast of northern and central California).
8. I grow and/or ship bulk romaine for regional processing. Do I have to label anything? No, the voluntary labeling initiative is aimed at communicating the source of the product to consumers. However, in order for your customer (the processor) to label their product with the source of romaine, that information will need to be communicated to them. This can be done in several ways, based on the agreements between the trading partners but should be as regionally specific as described below in Q12 and Q13.
9. When should we start using the label? This initiative is effective immediately.
10. Can I use product in inventory? The withdrawal was voluntary. Source labeling is a voluntary effort. FDA didn’t specify a threshold date for re-entry into the market, but stated that, on November 20, “FDA requested that all romaine lettuce on the market, including in restaurants and other commercial establishments, should be withdrawn and destroyed”. We suggest you work with your customer to determine the acceptability of product. Bear in mind that the harvest date and source should be communicated.
11. When can we stop labeling? Based on FDA Commissioner Dr. Gottlieb’s 11/23/18 tweets, and 11/26 Commissioner statement it appears that FDA expects that this labeling will be the “new normal” so that if there are outbreaks moving forward, FDA can limit advisories to affected regions, and consumers would be able to readily discern if they had packaged product from a potentially affected area.
12. What romaine-producing regions can be identified on the label right now? According to the FDA statement “Romaine lettuce harvested from areas that include, but are not limited to, the desert growing region near Yuma, the California desert growing region near Imperial County and Riverside County, the state of Florida, and Mexico, does not appear to be related to the current outbreak. Additionally, there is no evidence hydroponically- and greenhouse-grown romaine is related to the current outbreak.”
13. How should regions be named? This has not been clearly defined by FDA. In the FDA statement they note the desert growing region near Yuma, the California desert growing region near Imperial County and Riverside County, the state of Florida, and Mexico, as well as hydroponically- and greenhouse-grown romaine. Better defining the terminology and granularity for growing regions will be one of the first tasks of a small group that will continue to review and refine source labeling. Some industry members have adopted the following in the interim: for California: Hollister, San Juan Bautista, Watsonville, Salinas, Gonzales, Soledad, King City, Shandon, Huron, Santa Maria, and Oxnard, all of which are currently subject to FDA’s adviser; and Coachella, Brawley, Imperial, Calexico, Winterhaven, and Somerton; for Arizona: Yuma, Bard, Dome, Welton, Roll, Tyson, Growler; as well as individual states or countries as applicable.
14. Rather than stating the growing region, can I state “not from the central coast of CA” along with the date? This is not a long term solution because the current FDA and CDC advisory directs consumers to only purchase romaine certain to have been harvested from areas outside of the Central Coast growing regions of northern and central California. However, this advisory will ultimately be lifted. At that time, and as the Central Coast of California resumes production, consumers may be accustomed to seeing the origin of romaine.
15. Rather than stating “harvested on” can I state “packed on?" The FDA update specifically notes “harvest date”. Alternative language can be considered in the future, but is currently outside the scope of FDA’s expectation.
16. How should the date be expressed/ formatted? FDA has not provided any guidance on this. At this point in time we recommend the date be communicated as “mm/dd/yr.” Some companies may elect to label with only mm/dd. Those selling into the Canadian market may need to alter the date format to comply with Canadian labeling regulations. For simplicity in the case of dual labeling, it is important to have year as four digits (2018) if a single label complaint with Canadian standards (Year first) is more practical.
17. Can information regarding the source be abbreviated? FDA has not provided any guidance on this, but we expect the source can be abbreviated to use a state abbreviation (e.g., FL for Florida) if there are size constraints on a package. However, since the goal is consumer understanding, abbreviations should be limited to those that would be readily understood by consumers (e.g., do not abbreviate Imperial Valley, CA as IV since that is meaningless to consumers). Industry feedback shows that a wide variety of abbreviations are being used and its clear that a broader discussion on this topic is needed to limit confusion.
18. How can product grown indoors be labeled (hydroponic, greenhouse etc.)? Given that this is a voluntary initiative, FDA did not specify terminology that should be associated with romaine grown indoors. Indoor growers should use a term that facilitates consumer understanding. This could include, but is not limited to, phrases such as “grown indoors”, “greenhouse grown” etc.
19. What kinds of label materials can be used? FDA has not provided any guidance on this but has indicated that bagged products that will be sold directly to consumers (e.g., at retail), the source and date information should be printed directly on the package (e.g., ink jet). Labels can also be printed directly on cartons for salads or field-packed product or they may be printed on stickers and placed on cartons. Remember, the stickers or printed labels on cartons must be easily found by the receiver as they will need to be able to communicate with consumers directly.
20. For dual jurisdiction facilities, will this require a label review by USDA FSIS? At our urging, FSIS posted an ask FSIS” Q&A that states “FSIS will permit a statement identifying the harvest location and date, consistent with FDA’s advice, on meat or poultry products that contain romaine lettuce. FSIS will also permit statements identifying that a meat or poultry product does not contain romaine lettuce, e.g., adding a sticker to a label that states, "Does Not Contain Romaine Lettuce". The addition of these statements to labels does not require submitting the labels to FSIS for sketch or temporary approval. Both types of statements are not considered special claims and are generically approved under Title 9 of the Code of Federal Regulations (CFR), Part 412.2.”
21. What fonts and print sizes can be used? FDA has not opined on this, but it is reasonable that the font and print should be no smaller than that used to convey lot information. It must be easily viewed and discernable by consumers.
22. Where should the label be located on the package or box? On consumer-level packages, the statement should be prominent and easily viewed by consumers. When ink-jetting, it is recommended that the label immediately follow information pertaining to lot number/code.
23. Must the harvest date and source be printed on the PTI label? No, this information can be provided in a separate label.
24. If a supplier chooses to include source and harvest date information on the PTI label, is there any guidance? We suggest that this information be printed using any open space on the PTI label, with a font size consistent with other human readable information. The objective is to have this information be communicated clearly through the supply chain to retailers, foodservice operations, institutions, etc.
25. What if product contains romaine from multiple sources? If product is commingled and contains romaine from multiple regions, then an “and” statement should be included; e.g. Romaine grown in (source) and (source) and harvested after (date). Labeling should be as accurate as possible but could include the use of an “and/or” declaration if there’s a real potential for romaine from multiple origins to be in the product (e.g., “Romaine grown in Yuma and/or Florida and harvested after 11/23/18”).
26. If my company participates in this label program, do we have to use this label for blended romaine products? This label is suggested for any product containing any amount of romaine. This is a voluntary effort, but consumers are being advised to only purchase products bearing this label or that have accompanying signage.
27. What information should the in-store point of sale signage contain? Produce suppliers of bulk romaine lettuce should provide retailers with accurate harvest information including location and date(s). FDA did not specify a specific format, font size, location, or material for signs, but did indicate that signs should clearly communicate to consumers the approximate date and region of harvest.
28. If products are transformed in-store and don’t bear a label what is suggested? CDC advises that “restaurants and retailers should check the label on bags or boxes of romaine lettuce, or ask their suppliers about the source of their romaine lettuce. Do not sell or serve any romaine lettuce harvested from the Central Coastal growing regions of northern and central California”. Retailers transforming product in-store should ensure that the romaine used meets these criteria, and should be prepared to address consumer questions.
29. Will restaurants need to provide source information to consumers? Foodservice operations should expect to field consumer questions regarding the source of romaine lettuce.
30. What if I ship to Canada? Based on their statement, CFIA is not requiring any additional information on the consumer package or cases. If Canadian importers receive or request additional information on labels, they are responsible for ensuring it is compliant with Canadian labelling regulations including those unique to Quebec. CFIA has implemented new requirements for import:
- Shipments of romaine lettuce from California must be accompanied by a letterhead, on a separate page, showing a Proof of Origin with the date of signing and the signature of the exporter declaring the municipality, county and the state (California) where romaine lettuce was harvested.
- Shipments of salads originating from all of the USA, containing romaine lettuce, will have to be accompanied by a letterhead, on a separate page, showing a Proof of Origin with the date of signing and the signature of the exporter declaring the municipality, county and state where romaine lettuce was harvested.
- Shipments of salads originating from all of the USA, which do not contain romaine lettuce, will have to be accompanied by a letterhead, on a separate page, with the date of signing and the signature of the exporter with the following text: “Does not contain romaine lettuce.”
- If you have any questions, please contact the CFIA National Import Service Centre (NISC) from 7:00 a.m. to 3:00 a.m. (Eastern Time) at 1-800-835-4486 (Canada or USA).
31. Must all points in the supply chain capture source information as part of their traceability information? No. However, the more complete your supply chain records are, the better. Your records can eliminate your company from a recall or in the case that you are indeed involved, they can speed up the traceback process and help the industry get to the root cause and use those learnings to prevent future outbreaks and loss of consumer trust.
32. Should the harvest date and harvest region be printed on the Bill of Lading? In the event you are involved in a traceback situation, this information could be useful in more quickly identifying and excluding shipments that may or may not be involved in an issue. The FDA advisory is silent on this issue.