The concepts of verification and validation leave most beginner food safety professionals confused.  On top of that there are two different aspects to verification and validation.  The first is related to specific food safety procedures (CCPs, GMPs, SOPs, etc) and the second is a global view.  Is the entire food safety system working?

Specific

•    Monitoring: Are the operations being done as intended? (present)
•    Verification: Was the work done according to the food safety plan? (past)
•    Validation: Are the plan criteria (e.g. critical limits) based on science?

Global

•    Monitoring: Is the entire operation being observed and assessed? (present)
•    Verification: Is all of the work done according to the food safety plan? (past)
•    Validation: Is the plan as a whole effective? (past and future)

FSMA Preventive Controls requires that Process Control CCP critical limits be validated by referencing the science or safe harbor (federal performance standard).  No other Preventive Control programs REQUIRE validation.  This includes allergens.  The FDA has not set threshold levels of allergen residuals.  On the global level, FSMA PC requires an effectiveness check (a) at the documentation stage, (b) just after the roll-out stage, and then (c) every three years.

Opposite to FSMA PC, most GFSI schema based on ISO 22000 and PAS 220 standards require formal validation of CCPs and operational prerequisite programs (oPRPs). In addition, cleaning and sanitizing programs must also be validated. Organizations must properly design, document, implement and maintain prerequisite programs, even if the standard does not specify a validation requirement for this part of the food safety system.

Process Validation focuses on the collection and evaluation of scientific, technical and observational information to determine whether control measures are capable of achieving their specified purpose (outcome or target) in terms of hazard control. Global Validation involves measuring an entire system’s performance against a desired food safety outcome.

December 2017

Disclaimer:  This is a best effort interpretation of FDA FSMA rules and guidance.  This information should not substitute for competent legal counsel.  Please report factual errors and instances where FDA is interpreting this differently.  I will update this note.   

As a brand-owner, what part of the new FSMA regulations (mostly Preventive Controls for Human Foods) must I be in compliance with?  That is a great, straightforward question.  However, like all governmental regulation questions, the answer is not straightforward.

We start with the fact that only those facilities that are required to register as a food facility must be in compliance with FSMA rules.  FDA says that if you are the owner, operator, or agent in charge of either a domestic or foreign facility that is engaged in manufacturing/processing, packing, or holding of food for human or animal consumption in the United States, you must register with FDA.  [21 CFR 1.226 lists exemptions from the requirement to register, such as farms and foodservice].  Therefore, if you are a brand owner of a food or beverage that is in a co-packaging arrangement, then the co-packer is the manufacturer and packager of the food.

Caveats.  As a brand owner, what is the level of involvement in the co-manufacturing/packaging arrangement? Do you get directly involved in any aspect of the purchasing, processing, packaging, holding of food arrangement? If yes, then you are required to register as a food facility and be in compliance to relevant parts of the FSMA rules. One less than obvious involvement is labeling.  If the brand owner applies labels or stickers to the food container, the FDA has said that is “manufacturing” (1).

Do you require specific suppliers’ ingredients be purchased for your product(s)? Or, do you buy the ingredients for delivery to the co-packer? If yes, then you may need to apply “Supplier Preventive Controls” regarding purchasing. If the ingredient would require a Supplier Preventive Control by the food manufacturer (your co-packer), then you must ensure that the same control is applied (whether by you or by the co-packer as a contractual agreement).

Do you provide labels or labeling instructions to the co-manufacturer?  In a similar manner to the above question, if you are in control of any part of the labeling process, then you must have (or you ensure the co-packer has) a food safety plan covering those controls.  Or, you can arrange by contract to have your co-packer ensure controls are in place.  Keep in mind that business contracts will dictate who pays for a recall if there ever is a need for one.  At the very least, a brand owner should verify food safety controls, especially those that could lead to foodborne illness or recall$$.

Basturma

Categorization of Special Process: Basturma is a dried whole muscle meat product. It is made in a similar manner to dried ham (prosciutto, parma and country ham), dried pork belly (pancetta), dried pork shoulder (coppa), and dried beef round (bresaola, beef prosciutto, and basturma).

Product Characteristics: Boneless beef, usually a high quality cut (incl tenderloin); salt (to dry cure – sodium nitrite recommended); spice paste (to cover surface).

Flow of foods: Intact beef rounds are trimmed of fat.  About 5 kg salt (or salt cure) is dry rubbed onto the surface of 50 kg meat.  The salt cure meat is placed into refrigeration for several days allowing meat juices to drain.  Some traditional Turkish processes include a several hour pressing step here to shape the meat and press out meat juice.  After the first dry salting (and pressing) the meat is again salted and dry cured for several more days at refrigeration (termed “burning”).  When the meat has a WPS ≥ 4.5% and/or an Aw of ≤ 0.96, rinse off salt. Optionally, press again at refrigeration.  Cover the surface with the spice paste.  Hang and dry Basturma at 60-75°F to Aw ≤ 0.85.  Refrigerate the Basturma as a non-RTE product. The final product is either sliced and packaged for sale, or sold in the whole form for slicing by the final customer. Cook slices before consumption. Basturma is cooked with scrambled eggs, cut into slices and fried, grilled lightly over a charcoal fire, or added as an ingredient to various stews and cooked.

Alternatively, whole beef Basturma can be vacuum packaged and pasteurized to become RTE.  The meat must obtain an internal minimum temperature of 145°F or 130°F for 30 minutes to be considered pasteurized and safe for RTE status. Even as a RTE dried food, it should still be refrigerated for best quality.  Note that under the US FDA model food code, once the meat reaches ≤ Aw 0.88 it is considered a non-PHF/TCS food and refrigeration is not “required” for safety.  Vacuum packaging of the non-PHF meat would not need additional HACCP controls under reduced oxygen packaging special processes.

Raw meat >>>> Trim fat,
trim width
>>>> Dry-salt-cure
@ ≤ 41°F
>>>> Salt penetration cure
@ ≤ 41°F to 4.5% WPS
(Aw ≤ 0.96)
>>>>
Rinse off
Surface salt
>>>> Cover surface
with spice paste
>>>> Dry @ 60-75°F
(15-24°C) to
≤ Aw 0.85
>>>> Refrigerate as a
not RTE product
(cook before use) or
>>>>
for a RTE Basturma…
Vacuum
package
>>>> Immerse in 145.5°F
water until center
is 145°F or
>>>> Immerse in 130.5°F
water until center
is 130°F for 1 hour
>>>> Refrigerate as a
RTE product

CCPs:

CCP 1&2: Refrigerate while dry salt curing ≤ 41°F.
CCP 3: Dry ≤ 75°F to ≤ Aw 0.85
RTE CCP 4: Pasteurize to internal temperature ≥ 145°F.

Food Safety Notes:
For dried intact meat products, preservation is mostly due to the slowing or complete inhibition of surface growth, although inactivation of pathogens such as Salmonella, Listeria monocytogenes, and E. coli O157:H7 is desired. In the Basturma process, salt and refrigeration are the first hurdles that slow pathogen growth. A 6-7% WPS in the final dried product is desired.  Sodium nitrite is highly desired to inhibit C. botulinum and C. perfringens.  The USDA FSIS recommends a starting raw meat pH ≤ 5.8 as another hurdle.  Fermentation (acid production or pH drop) is not a control factor in Basturma, so the finsihed product pH will be similar to the starting raw meat pH.  A final moisture content of 40-45% is a hurdle.  An Aw 0.90 prevents growth of all pathogens (including S. aureus anaerobically) if the meat is vacuum packaged. If oxygen is present then an Aw ≤ 0.85 is required to prevent growth of all pathogens.  Lastly, the spices and spice extracts in the spice paste have pathogen inhibitory affects.

Aksu et al 2016 – Using sodium nitrite significantly increased both the safety and quality (color and oxidation) of Basturma.  Aksu noted that Turkish Food Safety law (2012) states that minimum moisture content for Basturma is 45% (not RTE) and 40% RTE.  The WPS of the finished product was 6-7%.

Ingham et al 2005 – Food Safety of the Basturma process.

Genigeorgis, C. and S. Lindroth. 1984. The safety of basturma, an Armenian-type dried beef product with regard to Salmonella. Proceedings of the 30th European Meeting of Meat Research Workers. 30:217-224.

Black garlic is “hot fermented” fresh garlic (Allium sativum) has been produced in several Asian cultures for centuries.  Full bulb garlic is kept at a controlled high temperature (60–90°C | 140-195°F) and high humidity (80–90%) for a week to several months.  A Maillard reaction (browning) turns the garlic its black color.  Natural biota (bacteria and yeasts) capable of growth at these high fermentation temperatures contribute to some chemical changes, while the heat of the process results in other chemical changes.  In the end, the garlic is sweeter, lacks allicin (sulfur bitterness), and is umami-rich.  Unfortunately, there is little research-based information on the “fermentation” characteristics of black garlic.

Food Safety | The “fermentation” temperature MUST be at 57°C (135°F) or above.  Failing to maintain this temperature control could lead to foodborne illness.  Foodborne illness bacteria will begin to grow at temperatures just under 57°C (135°F) including Clostridium perfringens and Clostridium botulinum.  The toxin produced by C. botulinum is the most potent and deadly toxin known to man.  For that reason a temperature datalogger is recommended.  This tool will monitor temperature for many weeks.  The data can be downloaded to a computer file.  It is advised to place the datalogger unit outside the fermentation chamber and the probe inside.  Prolonged exposure to the warm temperatures and high humidity can shorten the life of the datalogger unit.

The black garlic fermentation is quite different than a traditional vegetable fermentation like sauerkraut (cabbage) or pickles (cucumbers).   Both cabbage and cucumbers have natural (biota) lactic acid bacteria that rapidly ferment the vegetable sugars in a salt brine at ambient temperatures.  This rapid fermentation inhibits the growth of pathogens like C. botulinum.  Once the brine reaches an acidity pH of 4.6 or less, C. botulinum cannot grow.  The black garlic fermentation may or may not result in an acid fermentation.

The post-fermentation properties of the black garlic determine how it must be stored for safety (ambient or refrigerated).

  • If the pH is ≤ 4.2; the black garlic may be packaged for ambient (room temperature) sale.
  • If the pH is > 4.2; the black garlic must be refrigerated or,
  • If the pH is > 4.2; and the Aw (water activity) is ≤ 0.85, the black garlic may be packaged for ambient (room temperature) sale.
    Note that water activity meters are expensive (> $2,000).  Some food testing labs will test a sample for Aw at $10-$30 each.

Black Garlic Production HACCP CCP Summary

Fermentation temperature ≥ 57°C (135°F)

Critical Limit Monitoring Corrective Actions Verification Records
≥ 57°C (135°F) Digital Thermometer
Datalogger
If < 57°C (135°F)
discard*
Datalogger chart
Calibrate thermometer
Save chart to
computer file

*Another corrective action would be to test the pH.  If the pH ≤ 4.2; then the temperature critical limit is no longer needed.

Acidity (pH) ≤ 4.2 required for ambient storage

Critical Limit Monitoring Corrective Actions Verification Records
≤ 4.2 Digital pH meter
(bulb puree*)
If > 4.2;
(a) refrigerate or freeze,
(b) continue to ferment
Calibrate pH meter Batch log

* Puree several bulbs.  Test pH of puree.  If needed, add one-tenth volume of distilled deionized water (not tap) to help liquefy the puree.

Water activity ≤ 0.85 required for ambient storage at pH > 4.2

Critical Limit Monitoring Corrective Actions Verification Records
≤ 0.85 Digital Water activity
meter (per batch)
If > 0.85 Aw;
(a) refrigerate or freeze,
(b) hot air dry ≥ 57°C (135°F)
Calibrate water
activity meter
Batch log

A custom exempt meat processor is defined in State and Federal law as a processor that does not require continuous inspection because they only process meat for the owner of the animal. The meat or poultry cannot be sold and can only be consumed by the owner of the animal, the owner’s immediate family, or the owner’s non-paying guests.  The following are general food safety requirements.

  1. The facilities for custom processing must be constructed in such a manner that they comply and are approved by the Health District AND can maintain separation of custom processed meats from retail meats.
  2. The carcass or meat must be received in a safe, unadulterated, and honestly presented condition.
  3. Attach a tag, with the words “NOT FOR SALE” in large letters to all incoming carcasses; include a space to add owner’s name and date received.  Add another space for a carcass number.
  4. Store all custom processed animals and animal products in a protected manner on separate shelves while in cold storage.
  5. A “NOT FOR SALE” tag, with a corresponding record number from the original tag, should be attached to any packages storing custom processed animals or animal products.
  6. Use a dedicated processing area to process custom processed meats.  Any equipment used to process game animals or meat must be thoroughly cleaned and sanitized before it can be used for processing domestic meat, poultry, fish, ready-to-eat foods and other retail products.
  7. Keep a record (log book) of the name and address of the owner of each carcass, the species, date received, dressed weight and the assigned designated carcass number to the tag. Records should be maintained for at least 6 months and should be available during reasonable hours for inspection by the Health District.

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(from FDA) May 16, 2018

A new section of the FDA Data Dashboard has been launched to help importers and manufacturers/processors meet supply-chain requirements under the FDA Food Safety Modernization Act (FSMA) by helping them more easily find compliance and enforcement information related to specific firms. Three of the FSMA rules contain supply-chain requirements: the Foreign Supplier Verification Programs rule, the Preventive Controls for Human Food rule, and Preventive Controls for Animal Food rule.

The Foreign Supplier Verification Programs rule requires importers to perform risk-based activities to verify that their suppliers are meeting applicable U.S. food safety standards. One such activity is an evaluation of a supplier’s performance and the risk associated with the food, a process that includes evaluating a supplier’s compliance with FDA regulations such as whether the supplier is subject to an FDA warning letter, import alert, or other FDA compliance action related to food safety. The Preventive Controls rules require manufacturers/processors to perform supplier approval if the ingredient supplied contains a hazard requiring a supply-chain applied control. Supplier approval includes consideration of the supplier’s compliance with food safety laws and regulations.

To assist with the evaluation process, FDA created a Supplier Evaluation Resources page to help importers and manufacturers/processors find relevant compliance and enforcement information for their suppliers, but that page required them to search multiple data bases.

The FDA has improved the Supplier Evaluation Resources page, which is now available as a new section in FDA’s Data Dashboard. The Data Dashboard brings all the information from the Supplier Evaluation Resource page together, allowing importers and manufacturers/processors to search multiple data bases at the same time. The dashboard can be used to find information regarding warning letters, import refusal, import alerts, and other firm-specific information with one search.

The FDA Data Dashboard was launched in 2014 to provide stakeholders with information on FDA’s compliance, inspection, and recall activities in an easy-to-read graphical format. The expansion of this platform to make it easier to search for purposes of fulfilling supply-chain requirements under the FSMA rules is one way FDA is working to help industry comply with the new food safety standards.