I think what you shared is great Charles, but unfortunately again pertains to FSIS/USDA instead of FSMA/FDA. Frozen vegetable products, which have been "pre" cooked and IQF frozen are in this uncertain area, and it seems like I am not the only one who wants clarification. I am curious if these non-ready to eat statement at all protect the manufacturer in a situation where the consumer chooses to disregard the instructions. Consider for instance frozen corn, peas, beans, carrots, etc which have received the pre-cooking step, but still contain the instructions of these products "needing to be cooked." If they are removed from that packaging, consumed without cooking, and there is an issue..... who is responsible? Who dictates if a consumer should be made aware of the need to cook the product, or if the manufacturer should make certain that their food safety program is robust enough that the product can be thawed and eaten without any cooking/thermal treatment. The USDA is pretty clear on this, including defining RTE vs NRTE (or ready to cook), and including safe handling instructions. The FDA, not so much.
You may have missed some of the relevant attachments.
FDA and USDA's differing approaches to product interpretation/ labelling has apparently evolved/impacted in various ways.
(1) See file nr2. This is 2008 and somewhat incidental to the OP but illustrates potential effect of shared product responsibilities for sandwiches. It led to a call for USDA to take over the whole issue but apparently the status quo remains.
A deli product in a sandwich goes through many obstacles before it is used in a closed faced sandwich. The deli product must be produced meeting the guidelines outlined by the USDA before it can be distributed. A USDA inspector is present in the manufacturing facility daily to monitor production to ensure HACCP and prerequisite programs are being followed. If the deli product doesn’t meet these hurdles the product can be placed on hold before distribution or recalled. The deli product is only one component in the sandwich. The FDA monitors the remaining components of a sandwich.
Sandwich components, such as vegetables, cheese, condiments and bread, are held to different standard than the deli product since the FDA monitors them. The FDA has different guidelines for their items. The FDA has not mandated HACCP in these types of products. The FDA does not classify products based on how they are consumed, in other words they don’t classify products as ready to eat or not ready to eat.
Recent recalls have provided evidence that lettuce, cheese and tomatoes are at the same risk as deli products to cause food born illness outbreaks.
(I assume FDA now are doing some classification into RTE and NRTE as per next example)
(2) Currently and probably more aligned to the OP, see file nr3 (2018) which afaik relates to FDA controlled products.
Based on the text, this example has apparently become FSMA-accelerated. A sample extract -
NRTE Labeling
Dry pasta has always been positioned as an NRTE food, but typically does not bear labeling cautioning consumers that it is necessary to cook pasta prior to consumption. Because consumer preparation is the kill step, FDA might ultimately recommend that dry pasta bear a label statement alerting consumers to cook the food before consumption. That is, because consumer preparation is being relied upon to control the HRPC, FDA may take the position that consumers need to be notified that adequate preparation is critical for food safety.
Related industries have started following this approach by labeling their products to signal for consumers that they are NRTE. For example, the North American Millers’ Association (NAMA) has advised its members to consider labeling raw flour as NRTE by using a statement such as the following:
SAFE HANDLING INSTRUCTIONS: Raw flour is not ready-to-eat and must be thoroughly cooked before eating to prevent illness from bacteria in the flour. Do not eat or play with raw dough; wash hands, utensils, and surfaces after handling.
The flour industry has started adopting this or similar labeling. NAMA also is working to educate consumers on proper handling and baking instructions for products containing flour.
Additionally, the American Frozen Food Institute (AFFI) is considering similar issues as it works to reinforce historical regulatory policy that frozen vegetables are NRTE. For example, AFFI is planning consumer research regarding cooking instructions to determine what language has the biggest impact on consumer behavior.
Additionally, the American Frozen Food Institute (AFFI) is considering similar issues as it works to reinforce historical regulatory policy that frozen vegetables are NRTE. For example, AFFI is planning consumer research regarding cooking instructions to determine what language has the biggest impact on consumer behavior.
......................
.....................
As such alignment develops, NPA will consider whether to recommend NRTE labeling for dry pasta.However, each NPA member needs to make their own decision about how to label their products. Some companies may decide that they want to proceed with NRTE labeling now.
Meanwhile, there have been discussions between other trade associations and FDA regarding more clearly delineating the line between RTE and NRTE foods. We understand that FDA is working on a guidance document on this issue, which should provide further insights.
It would appear that currently Manufacturer's envisage any negative impacts will be, at least initially, "on them".
So they are actively working to cover their backs with FDA (similar to Post2 !)
So the specific answer to yr OP appears to probably be "indeterminate" until somebody sues somebody else. Or the labelling is widely changed.