ROP Q and A

ROP Q and A (based on FDA Model Food Code 2009).

General Questions
What is ROP? ROP is reduced oxygen packaging. It includes cook-chill, sous vide and vacuum packaging. It will also include any modifications of these procedures where foods are placed in bags and stored refrigerated.
 
Is ROP safe?  Reduced oxygen packaging is very safe provided operators follow a food safety program where they control the critical steps in the process (Cooking, cooling, and refrigeration). 
 
Is ROP a greater risk than traditional storage methods?  No.  Many processes that store foods in containers other than bags result in a reduced oxygen atmosphere.  For example the bottom 75% of food in a deep pan has the same reduced oxygen atmosphere as food in an ROP bag.
 
Is sous vide cooking and immediate serving considered ROP? Under the current Food Code text, it is still considered ROP. However, from a risk standpoint, this should not be considered ROP. Clarification and an exemption will be requested at the 2012 CFP meeting.
 
Is bagging foods followed by submersion in ice water considered ROP? Yes and no. If the food is removed from the bag after cooling, no. If the food remains in the bag and is refrigerated, yes.
 
Can I bag (without a vacuum) cold foods into ROP bags? While this process does not fit as cook-chill, sous vide or vacuum packaging, it is considered a potential hazard. Therefore, an operator would need to request a variance from the RA and demonstrate how they will control the hazards of their process.
 
Can I ROP foods if my consumers are immunocompromised? E.g. can hospitals ROP? Yes. Implementing and verifying a valid HACCP program will ensure the safety of ROP foods. It is recommended to add as many barriers and hurdles to prevent the growth of Cb and Lm as possible. 
 
How is ROP regulated in grocery and retail? 
Sections 3-502.11 and 3-502.12 address ROP in the FDA 2009 model Food Code. Keep in mind that individual regulatory jurisdictions may have different code. You should consult your state or local health authority for details.
 
What is HACCP? HACCP stands for Hazards analysis and critical control points. It is a proactive food safety program that seeks to identify hazards in a food process and then control them to prevent foodborne illness.
 
Where can I get a glossary of terms or a key to all of the acronyms used? We are working on it.
 

Hazards of ROP
What are the main hazards of ROP in grocery and foodservice? The main hazards are Clostridium and Listeria monocytogenesClostridium perfringens can grow if the foods are not quickly cooled. A subset of Clostridium botulinum and Listeria monocytogenes are psychrotrophs and can grow slowly at refrigeration temperatures. Processes must also demonstrate proper cooking or other means to prevent foodborne illness organisms such as E. coli, Salmonella, and others.
 
If ROP is hazardous, why is it even permitted? ROP, when properly performed, is actually safer than traditional methods. Basically, there is less handling and less cross contamination potential when using ROP. Uncontrolled ROP could lead to C. botulinum or L. monocytogenes food poisoning that can result in serious illness or death.
How many people have been made ill due to uncontrolled ROP? Fortunately there are no recorded illnesses related to ROP in grocery or foodservice. There have been a few outbreaks related to improperly processed manufactured foods.
 
Tell me more about ClostridiumComing soon.
 
Tell me more about Lm. Coming soon.
 
What are the main ROP preventative measures used to prevent growth of Clostridium
-The food itself
-Cooking
-Cooling
-Refrigeration and shelf life
 
What are the main ROP preventative measures used to prevent growth of Listeria?
-The food itself
-Cooking
-Prevent cross contamination (Bagging & no bare hand contact)
-Refrigeration and shelf life
 
Are employees considered hazards? Not by the definition of HACCP. However, untrained employees do not possess the knowledge, skills, or abilities to exercise control over the ROP process. The result is a much greater potential for the true hazards, Cb and Lm to grow and make customers ill.
 
Can equipment affect the safety of ROP? YES! The equipment you use has a direct impact on the safety of ROP. Just like trained employees, the equipment must be capable of maintaining control over the factors that are critical to the safety of the process. E. g. temperature measurement - cooking, cooling, and refrigeration temperatures must be closely monitored. You will be expected to demonstrate that the equipment works for the task required. 
 
Properties of foods and ROP
Are any foods exempt from ROP requirements in the food code?
Yes. Any food that is not potentially hazardous or that does not require temperature control for safety is exempt from ROP requirements in the food code.  This is interpreted as "as received" and not modified in the facility.
 
What happens of a food is modified in the facility?  If an non-PHF ingredient is added to a non-PHF food, then the product should be considered non-PHF.  However, a process letter may be required to validate that determination from a process authority.  The acidifed foods regulations from FDA can help here.  Acid or formulated acid foods would be non-PHF.  If PHF foods are made non-PHF by addition of ingredients such as acidification or addition of preservatives, then this process requires a variance under 3-502.11.
 
What is considered a PHF?
Generally, a potentially hazardous food is one that could support the growth of a foodborne illness pathogen. The definition of a potentially hazardous food is found in 1-201.10. It is not fully clear that non-potentially hazardous foods are exempt from ROP food code requirements found in 3-502.11 and 3-502.12. The FDA (CFSAN) has issued an interpretation that designates non-PHF’s as exempt from the requirements of ROP in the food code. This clarification is part of the changes to be presented to at the 2012 CFP Conference – i.e. that foods determined non-potentially hazardous by using the interactions tables A and B in 1-201.10 would be excluded from ROP food code requirements found in 3-502.11 and 3-502.12. A requirement that these foods carry a label identifying them as non-PHF would be added.
 
Can I ROP fish or seafoods?
Seafood presents the highest risk for finding the type of botulism organism that grows slowly at refrigeration. However, with proper hurdles or barriers, seafood can be made safe for ROP. 3-502.12 (C) Except for FISH that is frozen before, during, and after PACKAGING, a FOOD ESTABLISHMENT may not PACKAGE FISH using a REDUCED OXYGEN PACKAGING method. There is no prohibition for ROP of fish with a variance.
 
Can I use acidity as a barrier to Cb and Lm?
Scientific evidence indicates that both Cb and Lm are inhibited from growth at pH 5.0 or less when held refrigerated at 41ºF or less. Under the present food code this process would require a variance except for vacuum packaged foods: 3-502.12 (B)(2)(b) permits vacuum packaging foods with a pH of 4.6 followed by refrigeration at 41ºF or below for 14 days or less.  The CFP ROP Committee is recommending a change in 2012 that acid and acidified foods be permitted under the no-variance section of the code (3-502.12).
 
Can I use water activity as a barrier to Cb and Lm?
Water activity (Aw) can be an effective barrier to CB and LM. However, verification of Aw is required. Verification can be supplied by a Certificate of Analysis of any unaltered food. It can be determined by measurement using a calibrated meter. Note that Aw meters are expensive. Lastly, Aw can be approximated by the amount of salt or sugar in a recipe or formula. The food code does not have specific language regarding Aw verification other than it may be used in ROP. It is implied that Aw measurements in certificates of analysis come from a trusted source. If an operator is using an Aw meter, then a measurement and calibration SOP is required along with appropriate records. If salt or sugar in standard formulas is being used, then documentation establishing the Aw based on quantity of salt or sugar is needed. A formula SOP and records would be required to verify Aw effectiveness.
 
 
Cooking and ROP
When is cooking a preventative measure for ROP hazards? Cook-chill and sous vide require cooking. Some foods may have been cooked prior to vacuum packaging. Effective cooking would be described in the Food Code under section 3-401.11. There is some concern regarding sections 3-401.11(C) and (D) that permit undercooking of foods. Form a risk based standpoint, this should not be permitted. However, the Food Code is not entirely clear. The CFP ROP Committee is recommending clarification of the code to require cooking to 3-401.11 (A)and (B). Other temperatures would require a variance and scientific data demonstrating their effectiveness.
 
Can I sous vide cook at temperatures below those specified in 3.401.11?
Temperatures below 129ºF may allow the growth of C. perfringens. As cooking temperature lowers, other pathogens may actually “grow” instead of die off. Low temperature cooking would require a variance with scientific data demonstrating a safe process.
 
Is cooking a barrier to Cb?
Cooking to standard temperatures of 145,155 or 165ºF will not destroy Cb. However, cooking to 90ºC (194ºF) for 10 minutes is considered lethal to psychrotrophic Cb. Cooking at any temperature is not an alternative offered for a no variance ROP process. If cooking were to be used as a barrier an operator would have to validate a process that meets the 90 ºC for 10 minutes process and get that approved by a variance. 

 

Cooling and ROP
When cooling per 3-502.12 (D)(2)(e)(ii) Cooled to 1°C (34°F) within 48 hours of reaching 5°C (41°F), removed from refrigeration equipment that maintains a 1°C (34°F) food temperature and then held at 5°C (41°F) or less for no more than 72 hours, at which time the food must be consumed or discarded is the 48h allowed for cooling from 41 to 34F included in the 72h shelf life at 41ºF? The US FDA CFSAN has interpreted that the 48h cooling limit is NOT included in the shelf life of 72h. Therefore, the effective shelf life of these foods are 2 days + 3 days =5 days.
 
Can I cool or store foods at ≤34ºF using a Lexan or clean garbage can with ice water placed inside a ≤41ºF refrigerator? Yes, according to the US FDA model food code. However, some jurisdictions prohibit “assisted” cooling. An example is the Southern Nevada (Las Vegas) Health District. If allowed, you would need to monitor the temperature of the ice water. If the food temperature rises above 34ºF the 72h shelf life with maximum temperature at 41ºF sets in.
 
Preventing Cross Contamination and ROP
Why must I bag foods before they reach 135ºF? Foods below this temperature may permit the survival of any cross contaminated microorganisms, specifically Lm.
 
What should I do if I need to cool meats below 135ºF so that they can be pulled before cook-chill bagging? Anytime cook-chill foods go below 135ºF, even momentarily, they must be fully reheated to a proper cooking temperature. So, to pull meats they can be cooled, pulled and reheated in juice to 155ºF. Then they can be bagged before they cool to below 135ºF.
 
Refrigeration and shelf life of ROP
What temperatures can I store ROP Foods at? There are three temperatures permitted for storage of ROP foods: 34ºF, 38ºF, and 41ºF. At 34ºF both Cb and Lm are prevented from growth. Therefore the shelf life is 30 days. At 38ºF, Cb cannot grow, but Lm can grow slowly. Therefore the shelf life is dramatically shorter, 72h. At 41ºF, the maximum permitted refrigeration temperature in the Food Code, both Cb and LM can grow very slowly. Therefore the shelf life is also only 72h. The shelf life’s mentioned here are for no-variance ROP HACCP. Longer shelf life’s can be justified scientifically using the variance process.
 
What is considered "extended" storage for ROP? Currently “extended storage” is not defined in the Food Code. Therefore the CFP ROP Committee will suggest that any food stored for less than 48h NOT be considered extended storage and should be exempt from ROP food code regulations. The exemption would come with a requirement that foods are labeled with a 48h date mark.
 
Can I store ROP foods longer than 72 h at 38 or 41ºF? Yes, but only with a variance. The FDA has documented that it takes 9 days for botulinum toxin to grow at 41ºF and the current Food Code permits 7 days at 41ºF for PHF(datemarking) regarding Lm. Therefore, based on science 7 days at 41ºF would be safe. A change permitting this temperature and shelf life is being recommended to the 2012 CFP conference.
 
Can I store ROP foods longer than 30 days at 34ºF? Not without a variance.
 
Can I store or handle ROP foods above 41ºF? No. If foods reach a temperature above 41ºF they must be discarded.
 
What constitutes 24/7 digital temperature monitoring? Typically, this is considered a temperature datalogger. Any datalogger that can be calibrated, monitor temperature, and provide a digital readout will work.   It is recommended that your datalogger have alarm lights or other communication abilities.
 
What ROP processes must be electronically monitored?  Under the no variance ROP section 3-502.12, vacuum packaging with two barriers and vacuum packaging cheese do not require electronic refrigeration monitoring.  However cook-chill and sous vide do.  Under a variance process (3-502.11), if a food has a barrier in addition to refrigeration, 24/7 digital monitoring should not be required.
 
What constitutes twice daily manual temperature "backup" monitoring?  Manual temperature monitoring implies monitoring the refrigerator and measuring temperature using a thermometer that is not part of the electronic monitoring system.  This can be done in-person or remotely, provided the remote system is not part of the electronic monitoring system.
 
Where does the digital temperature probe need to be? The Model Food Code says measures “ambient” temperature. Ambient would mean air temperature of a cooler and ice water temperature of a cooling bath. In practice it is not recommended to record only ambient temperature. Often, during peak use periods, refrigerators can warm up a little while the food remains cold. Therefore you should either place the probe in glycerol or place the probe between two food bags. 

How often should a datalogger be set to obtain temperature and download readings?
 Most dataloggers can handle 10,080 readings or more in their memory. Assuming the unit is equipped with an alarm, the readings can be downloaded at intervals up to 1-4 weeks. Reading once per minute for a week equals 10,080 readings. Reading once every 4 minutes would permit 10,080 readings over 4 weeks. There is no exact set minimum interval, but anything under 5 minutes should be sufficient. You should always leave yourself a buffer so that the unit does not shut off due to reaching the maximum number of readings. E.g. if you desire to download weekly, set your intervals so that the memory can handle up to 1.5 – 2 weeks of data. That way a little forgetfulness does not cost you the value of disposing all of your ROP foods.
 
How is refrigerated storage shelf life monitored? An effective ROP label is required that states the product, manufacture date, storage temperature requirement and expiration date.
 
What does an effective ROP label look like? Coming soon.
 
Can I open an ROP bag and remove the food to increase my shelf life? The food code is not clear on this. An interpretation has been offered by FDA CFSAN (Contact any Regional FDA Specialist to receive information on this, or any, FDA CFSAN interpretation). Yes. ROP bagged foods may be opened and removed to any non-ROP container (shallow pan, etc) provided it is opened PRIOR to the expiration date. The opened shelf life is the balance of the date marking shelf life (usually 7 days at 41ºF.). For example, an operator has ROP bagged foods stored at 38ºF for 48h. They then open the bag and pour the food into a Lexan dish. That food may then be stored for the balance of 7 days (7-2=5 days). The Lexan must be clearly date marked and re-bagging is NOT permitted.
 
Can I open an ROP bag, take some food out and reseal it?  Scientifically, there is a chance that the food in the bag can become contaminated with Cb or Lm during handling.  Even if the contents are contaminated with Lm, it will still take an amount of time greater than the current shelf life for Lm to grow.  Lets look at this more closely.  If a cook-chill bag of soup was made on Monday.  Using the no-variance process the soup was chilled to 34ºF, then removed to 41ºF on Tuesday.  The shelf life label says use or discard by Friday.  On Wednesday the operator opens the bag and removes half and reseals it.  During transfer the operator accidentally contaminates the soup.  If that contamination contained Lm it would need at least 7 days at 41ºF to grow and become potentially dangerous.  However the original shelf life is over on Friday, a full 5 days before Lm could grow.  Another factor in cook-chill is that soup is reheated to 165ºF.  That is lethal for Lm. 
 
Can I reuse foods that have been in ROP bags, opened, reheated and hot held? Yes. The same provisions as above applies.
 
Can I open ROP bags and expose them to air, then re-bag them to extend their shelf life? NO. No exceptions.
 
Can I poke a hole in ROP bags to make them non-hazardous? No. Poking a hole will not sufficiently aerate the food to prevent growth of Cb.
 
 
Equipment and ROP
Why is an equipment list required under ROP HACCP? The equipment used in ROP has a major effect on the safety of ROP. Also, an RA must understand the nature of the operation to gauge the effectiveness of a HACCP plan. For example, one operator may be using an automated large scale cook-chill system and another uses a cook pot and clean trash bin as an ice cooler. Temperature monitoring devises are perhaps the most important pieces of equipment. Listing these gives the RA assurance they will work for the task required.
 
Can I use 10K bags for cook chill, sous vide or vacuum packaging?
The 10,000 oxygen transfer rate bags or 10K bags were designed to shrink wrap fresh seafood without inclusions (e.g. marinades). They have not been scientifically validated for any other uses. Furthermore, these bags cannot withstand hot temperatures and cannot be used for cook-chill or sous vide.
 
Employees and ROP (Training)
Is employee training required for ROP? Yes.
 
What constitutes an educational program or event?
Any learning event is considered education. This would include both formal and informal training. For example, just demonstrating an employee a process is educational. A mixture of formal and informal training is recommended.  A learning event for the food code would require recordkeeping. If the event was not documented, then it did not happen. There is no specification on whether training and education must be formal (e.g. handouts, quizzes, etc). 
 
Are there any formal ROP training courses for either employees or supervisors? Yes. The Retail-foodservice food safety consortium is currently working to create an online training program. The employee training will be approximately 1 hour of learning and 30 minutes for an exam. The supervisor training will be approximately 4 hours of training and 1 hour for an exam. Any participant scoring above 70% will receive an ROP Training certificate.
 

ROP HACCP
Where do I find the requirements for a HACCP program? The details are found in the US FDA model Food Code 8-201.14(D).
 
Do I need formal training to understand HACCP?  Yes and no.  If you are very good at reading and understanding new concepts, you could read and learn HACCP on your own.  It is straightforward.  If however, you are not scientifically inclined, and are not skilled at self-learning, a HACCP course is recommended.  It would be preferential to find an ROP HACCP course.  At this time only the RFSC is providing ROP specific HACCP.
 
Do line employees have to have access to the HACCP program document?
No. HACCP documents must be available to supervisors who need to perform corrective actions. Line employees must have access to SOPs needed to perform their jobs.
 
Do employees have to understand recordkeeping forms?
Any employee that is responsible for entries in to or review of a record must have both knowledge and understanding of those records. 3-502.12 (B)(6) Describes the training program that ensures that the individual responsible for the reduced oxygen packaging operation understands the: (a) concepts required for a safe operation.
                             
Do employees have to understand SOPs?
Any employee that will be subject to an SOP must have both knowledge and understanding of the SOPs.
Section 3-502.12 (B)(6) states that employees must have training to include the operational procedures outlined in 3-502.12 (B)(5).
 
Do employees have to understand the HACCP plan?
HACCP documents the safety measures employed by an operation to prevent foodborne illness. The supervisor should have the necessary understanding of HACCP to read and understand the documents. Regular employees do not have to have that level of understanding. However, they must understand CCPs and SOPs, including the monitoring, corrective actions, and recordkeeping required.
 
Does each location of a chain need to have a written HACCP program?
Unfortunately HACCP cannot always be standardized across multiple units despite identical processes. Therefore, HACCP is specific to each facility or location and each should have a paper or accessible digital copy of all documentation. 8-201.14 specifies that EACH establishment must have a HACCP plan containing the information designated in that section.
 
Who is a processing authority?
A processing authority is not specifically defined in the Food Code. However, other governmental documents cite that a processing authority is someone with the knowledge and qualifications to understand the science behind a food process. This is usually a food microbiologist or similar educated person. Others may qualify provided they are acceptable to the regulatory authority. A processing authority in one area such as acidified foods may not be effective for ROP, since they may not be familiar with the process and the food code. The Retail-foodservice food safety consortium can help locate ROP Processing Authorities. Email brian.nummer@usu.edu.
 
Is HACCP just a document that can be shelved once the regulator has approved of ROP? No. HACCP must be validated, implemented and verified to be effective. Validation means the science supports the process. Implementation means that the CCPs, SOPs, and other preventative measures are in daily use. Verification means that supervisors have reviewed the effectiveness of the HACCP program including records. 
 
Is "ability to implement and monitor HACCP" a factor in receiving HACCP approval?
If an operator cannot ensure that HACCP is fully implemented and verified, then it does not work. Therefore, a HACCP program should NOT be approved or if previously approved, should be revoked.
 
Can my QA staff assist the regulatory authority in verifying one of my units has successfully implemented HACCP?  Yes.  Regulators have limited time during an inspection.  If QA staff have been through a facility and have produced a comprehensive audit of ROP HACCP, then keep a letter on file with the unit to present to the RA during inspection.  If nothing else, it will point out that the food safety program is being monitored by others.
 
What is a barrier versus a hurdle?
A barrier is any preventative measure that completely inhibits growth of foodborne illness pathogens. A hurdle is any preventative measure that partially inhibits growth of foodborne illness pathogens. Multiple hurdles can become barriers. An example of this is at pH 5.0 both Cb and Lm can grow at room temperature. However, at 41ºF and pH 5.0, neither Cb or Lm can grow at all.

Why does on RA require an operator to list a step in a process as a CCP while another RA will permit it to be an SOP?  Generally, any step that is critical to the safety of a process is deemed a CCP. However, in practice, this has a little flexibility. Typically, CCPs are steps in a batch process that can be corrected on the spot. Steps that are common across different batches may be placed as SOPs. An example is refrigeration. Generally, many batches are mixed together in the refrigerator. The refrigeration SOP specifies temperature and monitoring procedures. In this case it would be acceptable to have refrigeration as either a CCP or SOP.
 
No Variance ROP HACCP

Where are the code requirements for ROP without a variance?  It is found in 3-502.12.  Be aware that local jurisdictions may have slightly different codes and requirements.  Contact your specific RA before beginning to write a HACCP program or commencing ROP operations.

Do I have to have HACCP to ROP?  YES.  No exceptions.  Furthermore, the HACCP program must contain all of the needed parts specified in the US FDA model Food Code or as specified in local codes.

Do I have to notify the RA that I am doing ROP?  According to the US FDA model Food Code, no.  However, in practical experience, it is far better to notify the RA and send them a copy of your HACCP program, than to wait for their inspection.  If your HACCP program is insufficient, you will most likely get a cease-and-desist order during inspection.  In addition, many jurisdictions require preapproval (e.g. Colorado, So. NV Health, etc.).

What are some of the basics of vacuum packing under 3-502.12 (B)?  Foods that possess TWO barriers to Cb and Lm are permitted to be vacuum packaged and sold on or off premises.  The first barrier must be one or more of the following: Aw ≤ 0.91, pH ≤ 4.6, meat containing nitrite/nitrate, or contains high levels of competing microorganisms such as raw meats and vegetables.  The second barrier is storage.  These foods must be stored at 41ºF for a max. of 14 days.

Can I always get 14 days storage of vacuum packaged two barrier foods?  No.  For example, if you receive a beef round with an expiration date in 10 days.  You then slice and vacuum package that beef.  The expiration date must be the lesser of the original food's expiration or 14 days.  Therefore, the expiration would be in 10 days.

What happens after 13-14 days of storage?  The US FDA model food code specifies that the food must be consumed before 14 days.   It is not clear whether unused portions must be discarded or opened.  We are seeking an interpretation from CFSAN.

Can I open and use the vacuum packaged food to get a longer shelf life?  The US FDA model food code is not clear on this.  From a risk standpoint, if the food is cooked such as making a cheese sauce, then it would gain a new shelf life as a cheese sauce.  Same for vacuum packaged raw meats that are opened and cooked.  It is not clear whether cheese or meats could simply be removed from the ROP packaging to gain any shelf life time. We are seeking an interpretation from CFSAN.

Can I open vacuum packaged foods to introduce air, then re-vacuum package them?  No. No exceptions.  This is called rolling date marking.  It is not safe or permitted under the US FDA model food code.

What are the basics of cook-chill (CC)or sous vide (SV) under 3-502.12 (D) (No variance HACCP)?  CC/SV are not permitted for sale to consumers.  Foods must be properly labeled, fully cooked and packaged (CC) or packaged and fully cooked (SV), properly cooled, and then stored refrigerated for a limited shelf life (discussed below). 

What are the shelf life options for CC/SV under 3-502.12 (D)?  There are four options.  All require cooling to 41ºF first.  Then: (1) cool to 34ºF within 48h and store at 34ºF for 30 days; (2) Cool as in No.1, but then transfer foods to ≤41ºF where the shelf life at ≤41ºF is 72 h; (3) cool to 38ºF within 24h and store at 38ºF for 72h (from manufacture date); and (4) freeze and hold with no expiration date.

Can I remove foods from 34F storage to 38F storage?  Yes, but it is considered the same as number (2) above.

Can I remove foods from 41F or 38F storage to 34ºF storage and get additional shelf life.  Yes, if you are within the 48h window for cooling from 41ºF to 34ºF (see No 1. above).  Otherwise, no, not under the no variance portion of the food code (3-502.12).

If I freeze foods is there a time limit on going from 41ºF to freezing?  No.  The US FDA model food code does not specify that time.  However, it could be interpreted that an operator would have to go from 41ºF to 34ºF within 48h and then would have an unspecified amount of time to go from 34ºF to freezing (32ºF to 0ºF).  In a practical situation, operators should just demonstrate that foods freeze solid to the touch in 48h.

What are some of the basics of vacuum packaging cheese in 3-502.12(E)?  Cheeses listed in 21 CFR 133.150 Hard cheeses, 21 CFR 133.169 Pasteurized process cheese or 21 CFR 133.187 Semisoft cheeses may be vacuum packaged and stored at 41F for up to 30 days.

What happens after 30 days of storage?  The US FDA model food code states that the cheese must be sold for off-premise consumption or discarded.

Can vacuum packaged cheese be opened prior to its expiration date and used in an operation? We are seeking an interpretation from CFSAN.  From a risk standpoint, if the food was used as is, then it must be consumed on premise before the expiration date (e.g. free tasters or as deli slices).  If however, the cheese was processed into another food, such as cheese sauce, then it should be allowed addiitional shelf life of the new food product.

Regulatory Requirements
What is a variance? Coming soon.
 
What happens for ROP if I have multiple operations like a chain? Coming soon.
 
What happens if one regulatory authority requires me to change my HACCP program, while the remaining does not? Coming soon.
 
Can an RA add additional requirements to those listed in the food code for ROP HACCP?
All of the preventative measures for ROP should be in the HACCP program. Those deemed not scientifically necessary are not required.  However, RA’s may at their discretion may require additions to HACCP programs, plans, or documents. This is the nature of the individual regulatory agencies. There is nothing wrong with requesting a review of a requirement, especially for those multi jurisdiction chain operations.