Ready to Eat vs Non Ready to Eat

Hello!

I was hoping that someone has had some experience/can shed some light on labeling frozen food. Does the FDA specifically define something as "not ready to eat" or "ready to cook"? I am not able to find it in regulatory documents.

My question specifically pertains to frozen food that has been pre-cooked (for example, blanched). If the packaging from the manufacturer states that the product is "not-ready-to-eat" and must be cooked, is that a legal definition that protects the manufacturer from being responsible should someone not heed this instruction and eat the item without cooking it (ex: only thaw the item)? One example that I heard of happening is frozen peas, added to chicken salad without being cooked.

I have been able to locate guidance from the USDA, for "safe handling instructions," but not from the FDA.

If someone can please provide references/links, it is much appreciated.

Hello!

 

I was hoping that someone has had some experience/can shed some light on labeling frozen food. Does the FDA specifically define something as "not ready to eat" or "ready to cook"? I am not able to find it in regulatory documents.

 

My question specifically pertains to frozen food that has been pre-cooked (for example, blanched). If the packaging from the manufacturer states that the product is "not-ready-to-eat" and must be cooked, is that a legal definition that protects the manufacturer from being responsible should someone not heed this instruction and eat the item without cooking it (ex: only thaw the item)? One example that I heard of happening is frozen peas, added to chicken salad without being cooked.

 

I have been able to locate guidance from the USDA, for "safe handling instructions," but not from the FDA.

 

If someone can please provide references/links, it is much appreciated.

Hi sheeplewolf,

I suspect yr OP queries are complicated to answer.

The FDA definition of "ready-to-eat" is given/linked here -

https://www.ifsqn.co...at/#entry119630

I was unable to find  FDA definitions of the terms  NRTE and RTC. I also noted this -

July 2018

The microbial safety of “ready-to-eat” (RTE) foods is a hot topic that ASTA is hearing a lot about when it comes to implementation of the Food Safety Modernization Act (FSMA). The U.S. Food and Drug Administration (FDA) has not yet published guidance regarding classifying and processing RTE foods. In these “frequently asked questions” (FAQs), ASTA is sharing information on positions FDA could take on RTE based on the preambles to the FSMA final rules, talks that FDA officials have given, information published in the update to the spice draft risk profile, informal conversations with FDA officials, and other published FDA draft guidance. ASTA has produced these FAQs in order to help members understand FDA’s current thinking on RTE foods, but we note that we have not received input on this document from FDA.

https://www.astaspic...dy-to-eat-faqs/

 

In contrast, and perhaps in agreement with yr own comment, these more detailed "definitions" were, IIRC, quoted from a USDA web-page -

https://www.ifsqn.co...ook/#entry60365

The details  illustrate that some practical situations can be distinctly non-simple.

No idea as to yr US legality questions. Sorry. You may find the comments in surrounding posts of  above links interesting.

Hi Charles,

Thank you for the response. Yes, this is essentially exactly where I am at with my own understanding. I also did come across the same information from ASTA, but it more directly pertains to spices (which obviously this is very relevant to as well). I was wondering specifically about frozen food, due to the frequency with which I have seen recalls, and furthermore because I have noticed multiple times on packaging "not ready to eat," or instructions for cooking. This is why I wanted the IFSQN's input/thoughts/knowledge/etc on how exactly this issue is governed by the FDA, and the implications of including "not-ready-to-eat" and "ready-to-cook" statements on packaging.

Thanks!

Hi Charles,

 

Thank you for the response. Yes, this is essentially exactly where I am at with my own understanding. I also did come across the same information from ASTA, but it more directly pertains to spices (which obviously this is very relevant to as well). I was wondering specifically about frozen food, due to the frequency with which I have seen recalls, and furthermore because I have noticed multiple times on packaging "not ready to eat," or instructions for cooking. This is why I wanted the IFSQN's input/thoughts/knowledge/etc on how exactly this issue is governed by the FDA, and the implications of including "not-ready-to-eat" and "ready-to-cook" statements on packaging.

 

Thanks!

Hi sheeplewolf,

Do you mean that you have seen NRTE etc labelling on products which are within the jurisdiction of FDA ?, ie not meat, poultry etc which are regulated by USDA. I'm only guessing but that would seem to be "informative" rather than legalistic.

There is some analogy to the "may contain XYZ" allergen abelling  which seems to be ubiquitous  but afaik not a FDA legal requirement. Whether the usage has ever been tested/demonstrated as effective in a US legal sense I do not know.

Hi Charles,

Yes, precisely. I cannot find a good example on google image search, but I'm thinking of frozen products like vegetables (for example, peas).

So if the product is under FDA, the label "not-ready-to-eat" and the cooking instructions provided by the manufacturer do not actually hold any weight, and the product is for all intensive purposes "ready-to-eat" until the definition changes? Am I understanding this correctly?

Thanks

Hi Charles,

 

Yes, precisely. I cannot find a good example on google image search, but I'm thinking of frozen products like vegetables (for example, peas).

 

So if the product is under FDA, the label "not-ready-to-eat" and the cooking instructions provided by the manufacturer do not actually hold any weight, and the product is for all intensive purposes "ready-to-eat" until the definition changes? Am I understanding this correctly?

 

Thanks

I would have thought that any NRTE label/labelled cooking instructions must be acted on accordingly. Particularly from a safety POV.

Just as an example, here is an extract from GMA's 2008 document on validation of cooking instructions for NRTE products -
 

 

Unlike ready-to-eat (RTE) food products, which are safe to consume regardless of the form purchased by consumers (e.g., frozen, refrigerated, canned), not-ready-to-eat (NRTE) products
require cooking by consumers for safety.  While most RTE meat and poultry products are covered by specific lethality performance standards in Food Safety and Inspection Service (FSIS) regulations, NRTE products are not, since they contain at least one ingredient for which the elimination of vegetative pathogens such as L. monocytogenes and Salmonella cannot be assured by the manufacturer.

 

  Entree-type products containing RTE (fully cooked) meat or poultry combined with a component that has not received a heat treatment for pathogens such as L. monocytogenes may be considered NRTE by FSIS, provided that certain explicit labeling expectations are met, including validation of the cooking instructions provided on the label. Testing the validity of the consumer cooking directions for NRTE products, especially frozen NRTE products, is an important and effective tool for ensuring the safe consumption of these products by consumers.  After several foodborne illness outbreaks due to undercooked frozen, raw, breaded poultry products in the last few years, FSIS issued a notice in late 2006 regarding such NRTE products available for retail sale.  Included in the notice was a charge to companies to validate the cooking instructions provided to the consumer.  Interest in these and similar frozen products intensified during the summer of 2007 when frozen NRTE products containing
RTE meat or poultry components such as pot pies and pizzas were implicated in foodborne illness outbreaks.

 

  The FDA currently [2008] has no specific regulations addressing NRTE products falling under its jurisdiction.  However, FDA fully expects NRTE products to be safe. Manufacturer validation of cooking instructions is a key step in ensuring that products, as used by the consumer based on manufacturer preparation instructions, are safe.

 

Guidelines for Validation of Cooking Instructions for NRTE Products.pdf   1.1MB   145 downloads
 

IMEX, have encountered more trouble from  NRTE products which look similar to the cooked version but have no labelled handling/cooking information.

Hi Charles,

So, does this mean that if FDA expects NRTE products to be safe, that if you eat a NRTE product without cooking it and following instructions, for all purposes it should be completely safe (per current FDA perspective on this)? As safe as something defined "RTE"? Legally speaking?

Thanks!

***Maybe I wan't clear****

What I meant was, does labeling something as not-"ready-to-eat" absolve the manufacturer of responsibility if someone chose to not follow the instructions, disregarded the not-"ready-to-eat" label, and got sick by eating without cooking/additional heat treatment.

***Maybe I wan't clear****

 

What I meant was, does labeling something as not-"ready-to-eat" absolve the manufacturer of responsibility if someone chose to not follow the instructions, disregarded the not-"ready-to-eat" label, and got sick by eating without cooking/additional heat treatment.

Hi sheeplewolf,

I suggest you ask the FDA.

If someone got sick from eating a product that you manufacture, it does not matter if you say "ready to eat" or not. An illness shows that somewhere within your food safety system has failed, so the company could still remain liable if a civil suit is brought on the company. I used to be in food safety for RTE meat products. Everything we produced was labeled "fully cooked", but also included heating instructions. As far as I am aware, FDA does not require you to state fully cooked on products if they have been, only that you cannot label fully cooked if the product has not gone through an approved lethality step. The reason that many manufactures do not label fully cooked product as such is to encourage the consumer to reheat product to 165 degrees. Think of a product like hot pockets for example, many consumers will eat these if a portion is still cold because they know it comes from the factory fully cooked. By not including "fully cooked" on the label it discourages consumers from eating it without a full rewarming. 

Hi JPainter,

Thanks for the response. Do you happen to know where the FDA requires/covers this "cannot label fully cooked if the product has not gone through an approved lethality step"?

I'm thinking of a hypothetical product (for example) like frozen green peas, which would have been blanched and IQF frozen, and are labeled "not ready to eat" with cooking instructions. If these were to be added to a chicken salad, do these need to be cooked? Or can they directly be added frozen/defrosted to the chicken salad, from the package.

They don't outright say that exact statement anywhere, because.... well it's FDA and everything has some ambiguity to it. But it can be inferred by their definition of RTE: "Ready-to-eat food (RTE food) means any food that is normally eaten in its raw state or any other food, including a processed food, for which it is reasonably foreseeable that the food will be eaten without further processing that would significantly minimize biological hazards."

I was stuck in meat processing mentality with the lethality statement, as foods like uncooked romaine lettuce are considered RTE. 

Hi JPainter,

 

Thanks for the response. Do you happen to know where the FDA requires/covers this "cannot label fully cooked if the product has not gone through an approved lethality step"?

 

I'm thinking of a hypothetical product (for example) like frozen green peas, which would have been blanched and IQF frozen, and are labeled "not ready to eat" with cooking instructions. If these were to be added to a chicken salad, do these need to be cooked? Or can they directly be added frozen/defrosted to the chicken salad, from the package.

Sounds like another good question for the FDA.

Hi JPainter,

Ok, understood. How do you think it would apply to a product that is not quite either, like my pea example? Pre-cooked product, which is labeled not-RTE, with cooking instructions....

Waiting on the FDA Charles, I imagine it may take them a bit to respond!

Good luck on getting a solid answer from FDA. The last question I asked that was similar to this, I got a response saying that they were declining to answer my question at this time!  :rolleyes: Am I correct in thinking you are conducting a process similar to the one described? If so, I would work with your supplier on getting a statement saying that the product has been heated to a temperature in the blanching process that would sufficiently eliminate any viable pathogens from the product. Keep in mind that the supplier will need to be able to show that this is the case. I would assume that they do not state that it is RTE for quality purposes (peas may be crunchy if not heated by manufacturers instructions). 

Hi JPainter,

Perhaps you were just unlucky. I got the impression from some other posts here that feedback was generally good.

Or maybe yr question was too tough for them. :smile:
 

JDPainter--Not quite correct haha... I am in the food industry, but am also a student actually! :) I am delving deep into some of these more gray areas.....

Essentially, I think that in the case of a hot pocket, or romaine, this is a more clear definition. For frozen vegetables, I don't think it is as clear. I am using the pea example only because I have heard of people doing this--adding frozen peas to chicken salad. So I am wondering, if these peas have a label--"not-ready-to-eat" on them, and they have been added to a chicken salad by someone else without cooking them (per the instructions), is there any issue? Because I would think that there could be an issue if that original label (NRTE) is no longer present, and the peas were added to the chicken salad sans additional cooking. I would think, logically, that not retaining that original label as you add the peas to the chicken salad would potentially be an issue.

It sounds to me though that the bottom line is that even if the peas are labeled "not-RTE," for all intensive purposes they're considered "RTE" by the FDA. "We labeled it non-RTE" would not protect a company.

This is an interesting topic. I am no longer in the meat industry, the company I work for now actually does exactly as your saying. We produce a frozen vegetable product that undergoes a heating process that would sufficiently eliminate any pathogens, but we do not label as fully cooked and include the instructions "heat to 165 degrees before consuming". The reason that we do this is because we do not have a system in which we can pack the product to ensure sterility. We do not have the capability to do IQF, so we utilize water to cool. I can tell you in our case product micro results come back similar to RTE products I have seen, but we use the heating statement to cover ourselves like you mentioned earlier. Our product is also often used with meat products, so by stating cook to 165 we hope to minimize negative results from cross contamination.

Glad it pertains and interests you! I find it interesting because of the lack of cut and dry guidance on it. Do you know if the statement does legally protect you, as far as the FDA is concerned... or do you include that statement for purposes of "good faith" in the hopes that the consumer will follow/take into consideration your instructions? I think obviously the main intent is to prevent anyone from getting sick, regardless of the legal ramifications and definitions... but I'm wondering if this does protect you legally by including it on packaging (especially for a product that isn't covered by USDA--which has specific safe handling instructions, etc).

Glad it pertains and interests you! I find it interesting because of the lack of cut and dry guidance on it. Do you know if the statement does legally protect you, as far as the FDA is concerned... or do you include that statement for purposes of "good faith" in the hopes that the consumer will follow/take into consideration your instructions? I think obviously the main intent is to prevent anyone from getting sick, regardless of the legal ramifications and definitions... but I'm wondering if this does protect you legally by including it on packaging (especially for a product that isn't covered by USDA--which has specific safe handling instructions, etc).

Hi sheeplewolf,

The RTE/NRTE topic vis-à-vis FDA/USDA has a substantial history.

afai can see, USDA (for meat/poultry) specifically introduced their own, more detailed, NRTE perspective into law ca 2005.

 FDA seem to  have taken a less explicit legality path, eg

Under FDA's laws and regulations, FDA does not pre-approve labels for food products.

https://www.fda.gov/...-labeling-guide

Is one legally more at risk by making a (provably) false statement rather than saying nothing at all ?.   Hmmm.  Any evidence in the courts ?

The FDA/FSIS jurisdictional and labelling differences are illustrated here -

nr1 - Some FDA vs FSIS Labeling Comparisons,2016.pdf   2.14MB   30 downloads

http://34.204.31.147...ences-part-one/

http://foodsafety.me...ences-part-two/

Historically, the differences have previously generated some intriguing situations, eg - 

nr2 - All+Sandwiches+Should+Be+Regulated+by+the+USDA.pdf   52.4KB   26 downloads

Currently FSMA is now perhaps "forcing" manufacturers themselves to re-consider their labelling where they feel consumer safety maybe at risk,eg  - 

nr3 - NRTE-Labeling-for-Dry-Pasta,2018.pdf   23.81KB   39 downloads

And similarly via Consumer focus group studies -

nr4 - Consumer preferences for NRTE labelling meat,poultry,eggs.pdf   111.64KB   27 downloads

Similar to recent posts I noticed, among others, these 2 tricky questions on FSIS website -
 

My establishment produces a not-ready-to-eat entree that contains a fully cooked, breaded boneless, chicken nugget. Does the labeling guidance for uncooked, breaded, boneless poultry products apply to the labeling of this product?

 

What are some distinctions an establishment may use when validating cooking instructions for products that contain raw or partially cooked poultry products described in FSIS Notice 75-06 [items which appear to be RTE but are not] versus those for other not-ready-to-eat (NRTE) products?

 

( Answers here -

nr5 - FSIS Supplemental Q andA.pdf   59.55KB   25 downloads

Letter_to_Industry_on_Frozen_Uncooked_Poultry.pdf   16.57KB   18 downloads

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.

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.

Well yes, I did see/read those.... and the AFFI statement in the pasta one is especially helpful. In general, with dry pasta, I would think it is blatantly obvious that it must be cooked.

Well yes, I did see/read those.... and the AFFI statement in the pasta one is especially helpful. In general, with dry pasta, I would think it is blatantly obvious that it must be cooked.

I have edited/expanded Post 22 for clarity.

nr5 also has some relevance.

Agree Charles, nr5, in particular on point #2. I really hope the FDA makes some headway in defining and addressing this issue, and making it more clear for industry (like USDA). Thanks for expanding on your post.