Friday, September 29, 2017

CDC MMWR - 2016 Outbreak of Campylobacter Linked to Undercooked Chicken Liver Mousse

In a 2016 case, 4 people became ill from Campylobacter after eating undercooked chicken liver mousse.  From the report, "During an inspection on July 15, the sous-chef solely responsible for preparing the chicken liver mousse demonstrated preparation to the CCPH food safety inspector, who observed that the sous-chef used the appearance of the livers alone to determine whether they were fully cooked. Final internal cook temperature of the largest liver measured by the inspector was <130°F (54°C), below the minimum 165°F (74°C) internal temperature deemed necessary by the Food and Drug Administration to eliminate food safety hazards"

Campylobacter is naturally found in chickens and is a risk for causing foodborne illness when there are cross contamination issues or undercooking.
CDC - MMWR
https://www.cdc.gov/mmwr/volumes/66/wr/mm6638a4.htm?s_cid=mm6638a4_e
Notes from the Field: Outbreak of Campylobacter jejuni Associated with Consuming Undercooked Chicken Liver Mousse — Clark County, Washington, 2016
Weekly / September 29, 2017 / 66(38);1027
Derel Glashower, MPH1; Jennifer Snyder1; Diane Welch, MS1; Shannon McCarthy1 (View author affiliations)
View suggested citation

Deli Chicken Salad Recalled for Potential Listeria Contamination

King Soopers retail chain is recalling deli chicken salad after the supplier indicated that the product may be contaminated with Listeria monocytogenes.  The product is a deli pack with the clear plastic tortoise shell packaging.

Listeria is a risk in premade salad items like this.  From the retailer's perspective, it is critical to ensure the supplier has tight controls and a solid enviromental monitoring system.

It is interesting to note that the recall was posted on 9/27, but the retailer was notified on 9/21.  This seems to be a pretty long delay.  Hopefully the recall began immediately at store level.

FDA Recall Notice
https://www.fda.gov/Safety/Recalls/ucm577865.htm
King Soopers Recalls Deli Chicken Salad Sandwich (6.8oz) Because of Possible Health Risk
For Immediate Release
September 27, 2017

Monday, September 25, 2017

This Week in Mislabeled Product - 9/22/17

A CA company is recalling Tasty Treats Nonpareils Milk Chocolate because it contains undeclared milk.  Yep, a milk chocolate product and forgot the milk on the label as an ingredient and as an allergen.  Note though, the label did have a precautionary statement that says processed in a facility that processes milk products, but it need to claim milk as an ingredient.  The problem was caused by a temporary breakdown in the company's label review process.

A NY firm is recalling the following products because an allergenic ingredient, milk, was not declared in labeling. CFIA detection initially found this issue, and we are voluntarily recall the similar ingredients of other products


FDA Recall Notice
https://www.fda.gov/Safety/Recalls/ucm576841.htm
First Source Issues Allergy Alert On Undeclared Milk In Tasty Treats Nonpareils Milk Chocolate
For Immediate Release
September 20, 2017

Nacho Cheese Sauce and Botulism - Case Findings and Recommendations

In May of 2017, there was a botulism outbreak involving nacho cheese sauce served at a California gas station.  It is easy to see from this that the gas station did not monitor temperature, so likely that the units were possibly shut off.  This is a TCS food item, and with that, strict temperature control is required.   Unfortunately, this type of nacho cheese sauce if often treated as a shelf-stable item.   In the recommendations below, it states that the cheese can be hot held for up to 6 days....so much for me eating nacho cheese on anything served on a food bar...not that I have eaten it ever in the past.

The California Department of Public Health released a memo regarding their findings and recommendations (abridged here, in full below).

Chicken Sashimi - Eating Raw Chicken is a Risk

Chicken sashimi is a raw chicken item being prepared by a few restaurants here and in Japan.  With chicken having a high prevalence of  Salmonella and Campylobacter, this product poses a high risk for foodborne illness, even if the surface is quickly heated.  

Buzz Feed
https://www.buzzfeed.com/michelleno/would-you-eat-chicken-sashimi?utm_term=.doj7ve8NN#.ayDka3Dpp
Food
Chicken Sashimi Exists, And Americans Are Freaking Out
Literally everyone on Twitter: "No."
Michelle No
BuzzFeed Staff

Sunday, September 24, 2017

Mexico - Meth Contamination Reported in 7Up

In Mexico, there has been one reported death and several illness from Methamphetamine, or meth, adulteration in bottles of 7Up soft drink.  This product tampering issue occurred in the Mexicali area, which is south of the Mexican border with California.

Washington Post
WorldViews Analysis
https://www.washingtonpost.com/news/worldviews/wp/2017/09/23/travelers-beware-meth-laced-7up-reportedly-causes-death-in-mexico/?utm_term=.25692ed9517a
Travelers beware: Meth-laced 7Up reportedly causes death in Mexico
By Rachel Chason September 23

Friday, September 22, 2017

Cyber Security for Automated Food Processing Equipment

A recent article in Food Safety Magazine discusses the concern of cyber attacks on the supply chain.  Basically, the issue would be when somebody gains control over your automated processing equipment.  This could result in processing changes or formulation changes that can lead to contamination issues.

A division of Homeland Security, ICS-CERT (Industrial Control Systems Cyber Emergency Response Team), monitors and reports such attacks.  In April, they reported such an attack on a food processing system.  In 2016, this group reported 3 incidents on the food and agriculture sector.

As a food safety professional, this is just another concern to keep you awake at night.
Of course, the big concern is that somebody turns your automatic palletizer into this:


Damn, that Skynet software package.

Food Safety Magazine
https://www.foodsafetymagazine.com/signature-series/when-food-safety-meets-cyber-risk/
Signature Series | September 14, 2017
When Food Safety Meets Cyber Risk

Thursday, September 21, 2017

Cold Brew Coffee Recalled for Botulism Concerns

A NY company is recalling its canned cold brewed coffee after it was determined that the product may be conducive to the growth of Clostridium botulinum, the causative agent of  botulism.  The product's name, interesting enough, is Death Wish.  Probably appropriate.

In canned beverages such as juices and teas, pH is often used as a control for preventing Clostridium botulinum growth.  For this, the pH is kept below 4.6.  The pH of coffee can vary widely from 4.2 to 5.2 or higher depending upon the type of coffee.  In making a canned product such as this, it would be important to adjust pH to a value below 4.6, if pH is used as a control.  Other controls may be used.



FDA Recall Notice
https://www.fda.gov/Safety/Recalls/ucm576809.htm
Death Wish Coffee Co. Announces Recall of Nitro Cold Brew Cans From Retailers, Online Sales
For Immediate Release
September 19, 2017

Wednesday, September 20, 2017

Dirty Deeds: Recent Food Safety Crimes from Modern Farmer

This is reprinted from Modern Farmer and thought it a nice summary of recent cases where company owners received prison sentences for shipping tainted product.  The reasons listed below are a little short in terms of the details, but it is a nice review.

Modern Farmer
https://modernfarmer.com/2017/09/dirty-deeds-recent-food-safety-crimes/
Dirty Deeds: Recent Food Safety Crimes
By Brian Barth on September 20, 2017

Early Exposure to Allergens is a Good Thing - Let Those Babies Play in the Dirt, Eat Peanuts

A study released by NIH (National Institutes of Health) shows that infants that lived in dirtier conditions had a lower risk of asthma. From the release, "Higher concentrations of cockroach, mouse and cat allergens present in dust samples collected from the children’s homes during the first three years of life (at age 3 months, 2 years and 3 years) were linked to a lower risk of asthma by age 7 years." This is not surprising. Also recently, FDA recognized that the introduction of peanut allergies before the age of three reduced peanut allergies later in life.  So FDA "announced they would allow updated labels on some peanut-containing foods that they may reduce the risk of allergens.

So it is a delicate balance.  Introducing children to allergens early, but not particularly harmful agents such as the bacterial pathogens Listeria or Salmonella.  As parents, there is a tendency to keep infants from playing in dirty conditions, but the exposure to allergens in those dirty conditions is important for exposure.  Not exposing kids to allergens early means that when they are exposed to them later in life, they are more likely to have abnormal reactions to them in the form of allergies.

So let those little kids play in the dirt.  Buy them a puppy.  Visit a friend who has a cat, is less tidy and has roaches(ewww).  Have you ever considered the reason why there is an increasing percentage of children with allergies is nothing more than the fact that we are too risk averse to giving them certain foods or that we are too clean?

As the adage goes - The key to a healthy immune system is a constant challenge. But perhaps better stated - The key to a healthy immune system is an early challenge.

NIH Release
https://www.nih.gov/news-events/news-releases/exposure-pet-pest-allergens-during-infancy-linked-reduced-asthma-risk
Tuesday, September 19, 2017
Exposure to pet and pest allergens during infancy linked to reduced asthma risk
NIH-funded study may aid development of asthma prevention strategies

Monday, September 18, 2017

WA Establishment Recalls Cooked Meat Products Due to Process Deviation with Potential for Staph Toxin

A WA establishment is recalling sausage and other cooked meat products due to "a possible processing deviation that may have led to staphylococcal enterotoxin contamination."  "The problem was discovered on Sept. 14, 2017, by FSIS Inspection Program Personnel (IPP) when they observed a possible processing deviation while reviewing records."  If one would guess, during the smoking cooking process, product remained in the temperature danger zone for an extended period, probably before reaching lethality. If Staphylococcus aureus was present at this time, there would be the potential for growth and toxin formation.  Further heating would not remove the toxin.

USDA FSIS Recall Notice
https://www.fsis.usda.gov/wps/portal/fsis/topics/recalls-and-public-health-alerts/recall-case-archive/archive/2017/recall-102-2017-release
German Sausage Haus, LLC, Recalls Meat Products Due To Possible Processing Deviation and Staphylococcal Enterotoxin Contamination
Class I Recall 102-2017
Health Risk: High
Sep 17, 2017

Friday, September 15, 2017

This Week in Mislabeled Product - ending 9-15-17

A CA company is recalling "272 cases of one specific lot of its 4-4 ounce packages of "San Francisco Seafood Salad Made with Greek Yogurt" bearing a UPC bar code of 47502 19701 because the individual cups inside the carton may be mislabeled as Seafood Salad with Real Mayonnaise and does not declare "milk"........The recall was initiated as a result of a consumer inquiry into a label inconsistency; the cups within the 4-pack sleeve were labeled as Seafood Salad made with Real Mayonnaise while the outer carton was Seafood Salad with Greek Yogurt."

A Michigan company is recalling approximately 123 pounds of meatball products due to misbranding and undeclared allergens,  The product contains soy which is not declared on the product label.  The problem was discovered during routine label verification checks

A retail operation in the upper Midwest US is recalling packages of its American Rye Bread and Caraway Bread, which contain undeclared allergens (milk, soy and egg) as a result of an update to the ingredient profile from the manufacturer of the base.  This appears to be one of those supplier related issues where the supplier makes a change in an ingredient.

A Colorado-based natural grocery chain, is recalling Natural Grocers brand Organic Deglet Noor Dates Pitted because it may contain undeclared coconut, an allergen.  The recall was initiated after it was discovered that product containing coconut was distributed in packaging that did not reveal the presence of coconut.

 A NY firm is recalling its 12-ounce packages of CHERRY VALLEY VANILLA CUPCAKES and CHERRY VALLEY CHOCOLATE CUPCAKES because they may contain undeclared milk allergens. The recall was initiated after routine sampling by New York State Department of Agriculture and Markets Food Inspectors and subsequent analysis by Food Laboratory personnel revealed the presence of undeclared milk allergens in the 12-ounce packages of CHERRY VALLEY VANILLA CUPCAKES which did not declare a milk ingredient on the label.



Simply Fresh Foods, Inc. Issues Allergy Alert on Undeclared Milk in Single Serve Cups of San Francisco Seafood Salad Made with Greek Yogurt
For Immediate Release
September 8, 2017
Contact
Consumers 1-855-207-2758  Media Dale Jabour  1-800-807-7335

Hurricane Irma - Impact on Food Safety

Hurricane Irma has posed a number of challenges to the food supply chain - from growers to restaurants, to consumers.

Millions of people are still without power 5 days after the hurricane. At this point, perishable refrigerated and frozen foods are certainly lost. This not only impacts products at home, but also those in restaurants and retail.

Flooding, especially in coastal areas impacted by storm surges, has impacted homes and businesses.  Any food contacting flood waters should be thrown out.

There has been a huge impact on the agricultural sector from both flooding and from wind. It is estimated that 50% of the fruit came off the region's citrus trees. Vegetable crops have also been lost in areas prone to flooding.

Orlando Sentinel
http://www.orlandosentinel.com/business/consumer/os-hurricane-irma-grocery-supply-chain-20170919-story.html
Hurricane Irma challenges Florida grocery pipeline
September 19, 2017

Hair as a Hazard - An Extreme Case - Hairball Formation

When evaluating food for hazards, hair is not normally considered a risk  It can be considered a sign of insanitary handling and preparation, or it can be the source of hazards such as the bacterium Staphylococcus aureus (an organism found on human skin), but in itself, is not a hazard.  However, here is a case where hair became a hazard.  A young woman ate enough hair overtime, that it formed a hairball in her stomach which led to deadly condition.

NY Post
http://nypost.com/2017/09/14/rapunzel-syndrome-teen-dies-from-eating-her-own-hair/
‘Rapunzel syndrome’ teen dies from eating her own hair
By Fox News
September 14, 2017 | 1:21pm

Tuesday, September 12, 2017

Pet Store Puppies Linked to Outbreak of Campylobacter

Puppies sold through Petland pet stores have been linked to an outbreak of Campylobacter.  There have been 39 cases (12 of those are store employees) in 7 states.  Age of those who became ill ranged from one year old to 77.

Petland doesn't necessarily agree with the assessment “The CDC has not identified any failures of Petland’s operating system that would lead to any Campylobacter infection. Petland reinforces proper hand sanitization before and after playing with any of our puppies with the many sanitation stations in each store and has strict kennel sanitation procedures and protocols put in place by consulting veterinarians.   “… we again stress the importance of proper hand sanitizing when handling pets and when handling their food or waste. It is also important not to let any dog lick your mouth.”

Campylobacter would be spread through the fecal material that can be left on the fur of the dog or even on the carpet.


Multistate Outbreak of Human Campylobacter Infections Linked to Pet Store Puppies
Posted September 11, 2017 9:00 AM ET
Outbreak Advisory
  • Cases 39
  • States 7
  • Hospitalizations 9
  • Death 0

Monday, September 11, 2017

Papayas Recalled After Tests Positive for Salmonella and New Outbreak

A California produce company is recalling Maradol Papaya after product tested positive for Salmonella.  Testing appears to have been done by FDA. 

This recall comes after a large Salmonella outbreak linked to papaya occurred in August.  This recent recall however, is an example of why it is important to track issues of the same or related product.  it only makes sense that when an outbreak occurs in product, in this case papaya, then the regulatory agencies will be focused on that and similar products.

FDA Recall Notice
https://www.fda.gov/Safety/Recalls/ucm575287.htm
Bravo Produce Inc. Recalls Maradol Papaya from Productores Y Exportadores De Carica Papaya De Tecomán Y Costa Alegre SPR of RL and Packed by Frutas Selectas De Tijuana, S. De R.L. De C.V. Because of Possible Health Risk
For Immediate Release
September 10, 2017


Friday, September 8, 2017

British Online News Report on Fear of Terrorist Attacks Using Food

A British online news report raises concern of an ISIS fueled terror attack through the contamination of food in grocery store.

Mail OnLine
http://www.dailymail.co.uk/news/article-4858242/ISIS-tells-fanatics-poison-food-Western-supermarkets.html#ixzz4s6QDPZDL
ISIS tells its fanatics to poison food in Western supermarkets after testing the method on its prisoners in Iraq

  • ISIS leaders are reportedly planning on poisoning food in UK and U.S. shops 
  • Used prisoners in Mosul, Iraq as guinea pigs to test poisons in foodI
  • Details of their 'tests' uncovered when Mosul was liberated this year 

By Sara Malm for MailOnline
Published: 15:30 BST, 6 September 2017  | Updated: 18:31 BST, 6 September 2017

This Week in Mislabeled Product - Sept 8, 2017

A grocery chain is recalling semi-sweet chocolate chips because the bags may contain milk chocolate chips and milk is not declared on the label.  While the statement does not tell how the issue was discovered, one could imagine either a some left-over milk chocolate chips left on the packaging line, or someone dumped the wrong chips during packaging operations.

A grocery store chain is recalling assorted muffin four packs that may include a banana nut muffin containing walnuts where that nut allergen not listed on the label.

FDA Recall Notice
https://www.fda.gov/Safety/Recalls/ucm574585.htm
Wakefern Food Corp. Voluntarily Recalls ShopRite Semi-Sweet Real Chocolate Chips
September 1, 2017

Plant-based Hamburger With Bioengineered Soy Meat Protein Questioned on Allergen Issue

The primary ingredient in the plant based hamburger (yeah, a fake burger) is being questioned due to the fact that it may be an allergen.  According to this article, the company had tested the bioengineered soy leghemoglobin for safety, but the FDA may still have concerns.

My concerns are a little different.....



Food Business News
http://www.foodbusinessnews.net/articles/news_home/Business_News/2017/09/Impossible_Burger_environmenta.aspx?ID={5C9956A8-4832-4A78-A853-05ECE1FF3D41}&e=mwb124@psu.edu
Impossible Burger, environmentalists clash over key ingredient
 Sept. 5, 2017 - 
by Erica Shaffer

Infant Probiotic Solution Recalled Due to Potential Choking Concern

Garden of Life is recalling their Baby Organic Liquid Formula because there is inadequate instructions for delivering the product to infants.  Evidently, the product is too thick.  Directions for using syringe are not adequate.


This is a probiotic solution.



FDA Recall Notice
https://www.fda.gov/Safety/Recalls/ucm575135.htm
Garden of Life LLC Issues Recall of Baby Organic Liquid Formula
For Immediate Release
September 7, 2017

Wednesday, September 6, 2017

FSIS Issues Updated Compliance Guideline for Control of Pathogenic E. coli (STEC) in Non-intact Beef

FSIS released an updated 2017 Compliance Guidance on Minimizing the Risk of Shiga Toxin-Producing Escherichia coli (STEC) in Raw Beef (including Veal) Processing Operations.  This guideline updates and combines information from both the 2008 Sampling Beef Products forEscherichia coli O157:H7 (August 12, 2008) and •Sanitation Guidance for Beef Grinders (January 2012).  "This guideline incorporates current Agency thinking on the use of antimicrobial treatments, establishment sampling programs, and other measures in the establishment’s HACCP system."

This guidance states "FSIS is revising [the previous guidance documents] because it has seen that many small and very small establishments have had difficulty in designing and supporting their HACCP system (e.g., HACCP plan, Sanitation Standard Operating Procedure, or other prerequisite program) in a manner to prevent, eliminate, or reduce STEC to an acceptable level."

The guidance applies to non-intact beef products including: "ground beef; beef that an establishment has injected with solutions; beef that is vacuum tumbled with solutions; beef that an establishment has mechanically tenderized by needling, cubing, pounding devices (with or without marinade); beef that an establishment has reconstructed into formed entrees; and diced beef less than ¾ inch in any one dimension."

Sliced Produce Recalled Due to Listeria

A Florida produce operation is recalling diced produce due to the potential for Listeria.  The product, packed in clear plastic container or in Styrofoam trays overwrapped with clear plastic film, is being recalled as the result of a single routine sample taken at a retail store in Georgia which revealed that the finished product tested contained the bacteria.

The product has already passed its expiration date.  The delay was probably related to sampling / testing / reporting.

In cases like this, the source of contamination often originates in the environment of the slicing and packaging operation.  Slicing/dicing equipment is a primary culprit because of the difficulty cleaning. Packaging machinery is another potential source.

FDA Recall Notice
https://www.fda.gov/Safety/Recalls/ucm574624.htm
Country Fresh Orlando LLC, Recalls Product Because of Possible Health Risk
For Immediate Release
September 2, 2017

Friday, September 1, 2017

Bad Pet Ideas for Little Kids - The Turtle Edition

CDC is reporting a large Salmonella outbreak linked to little turtles - 37 cases with 16 hospitalizations.  While FDA has banned the sale of little turtles (less than 4 inches) back in the 1970's for this reason, we have continued to have outbreaks.  Turtles and other reptiles can carry Salmonella and this is an issue with little kids in that they may be less likely to wash their hands afterwards, or may stick the animal in or around their mouth.  Other pets that have been problematic - baby chicks, frogs, and hedgehogs.  

CDC Outbreak Report
https://www.cdc.gov/salmonella/agbeni-08-17/index.html
Multistate Outbreak of Salmonella Agbeni Infections Linked to Pet Turtles, 2017
Posted August 29, 2017 1:00 PM ET

FDA Enforcement Report - Week of August 30, 2017 - Summary

FDA's Weekly Enforcement Reports - Whereas not all recalls are announced in the media or on FDA's Recalls press release page, all recalls go into FDA's Enforcement Report once they are classified according to the level of hazard involved.

As a way to see more fully issues occurring, we thought we might summarize the food related items (allergen issues are posted on This Week in Mislabeled Product).
  • Go-Fresh of MN and Fresh Venture of CA Mary's Harvest Fresh Foods, Inc. of OR were impacted when firm test results found potential E-coli O26 contamination in Broccoli Florets. This has impacted a number of brands. - Class 2
  • Lakeside Foods of WI is recalling french style green beans for potential Listeria contamination.  This company has has Listeria contamination issues in the past.  Class 2
  • Koogee-Queen Anne, of KY is recalling ice bream products due to E. coli and high coliform counts. - Class 2
It is interesting to note how these recalls were classified.  The recalls for broccoli due to E. coli O26 and for green beans due to Listeria were classified as Class 2 recalls even though these are serious pathogen.  This is because the packages had validated cooking instructions, with the thought that proper cooking would minimize the risk of these pathogens.   Now if these pathogens had genetic matches to a serious outbreak as determined by WGS, then this would be a different story.

This Week in Mislabeled Product - August 25 to September 1, 2017

A list of recalls related to mislabeling / allergens.


  • A Calif. establishment, is recalling approximately 15,092 pounds of beef, chicken and pork products due to misbranding and undeclared allergens The problem was discovered on Aug. 22, 2017 when FSIS Inspection Program Personnel observed that the establishment utilizes a soy protein concentrate in the production of several products, but the finished product labels do not declare soy. In addition, some of the same products contain wheat flour and wheat is also not declared on the finished product labels.
  • A Mass. established reissued a recall notice to include the states in which the product was distributed. The establishment is recalling approximately 3,448 pounds of chicken breakfast sausage products due to misbranding and undeclared allergens. The product contains soy lecithin, a known allergen, which is not declared on the product label. The problem was discovered during routine FSIS label verification activities
  • A Mass. establishment, is recalling approximately 32,228 pounds of fully cooked chicken sausage product due to misbranding and undeclared allergens, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today. The product contains milk, a known allergen, which is not declared on the product label. The problem was discovered by FSIS Inspection Program Personnel during routine label verification activities. There have been no confirmed reports of adverse reactions due to consumption of this product
  • A firm in MI, is recalling several brands of butter flavored popcorn because they may contain undeclared milk.  The recall was initiated after a non-illness consumer complaint in relation to flavor.
  • A distributors in GA is recalling 1467 packets of Jalebi because it may contain undeclared Almond pcs "This problem was highlighted by FDA inspectors while inspecting our food distribution facility. The problem was caused due to recent change in the packing of the product to enhance the appearance of the product."  (So what, now we could see the almonds that should not have been there?).


And from the FDA Weekly Enforcement Reports

  • Shatto Milk Co of Osborn, MO, labels on butter products failed to mention the milk allergen.
  • D&D Foods missed soy lecithin on the label for co-packed pizza products.
  • Penobscot McCrum missed milk on labels for Jo-Jo wedges (potato wedges)
  • The Best Bar Ever initiated a voluntary recall of the Peanut Butter Crunch flavor (40g size) because the individual wrapper mistakenly has a gluten-free logo on the label. The wrapper for Peanut Butter Crunch flavor (40g size), had a gluten-free logo on the individual wrapper label. The ingredient listing and allergen statements are correct. The only issue is the gluten-free icon was not supposed to be on that flavor


UDSA FSIS Recall
https://www.fsis.usda.gov/wps/portal/fsis/topics/recalls-and-public-health-alerts/recall-case-archive/archive/2017/recall-098-2017-release
Blossom Foods, LLC Recalls Frozen Meat Products Due to Misbranding and Undeclared Allergens

FDA Updates Preventive Controls Guidance With Chapter on Heat Processing PC

FDA updated their Preventive Controls Guidance document with a chapter on addressing the use of heat treatments as process controls.  To this point, the guidance provided somewhat similar information to that in the FSPCA manual, although the information is split differently among the chapters. However, the information covered in Chapter 6 goes into more detail, providing more information on heating, including examples for baking cookies, heating soup, and processing salsa.  This information covers how one would validate that information, and then implement and manage the process - monitoring, corrective actions, verification, and records.

Currently, the Guidance has 5 previous chapters, while Chapters 7 to 14 are yet to be released.

  • Chapter 1 is an introduction
  • Chapter 2 discusses how to conduct a hazard analysis.
  • Chapter 3 provides additional information on hazards in foods. For example, it discusses pesticides, animal drugs, and mycotoxins as chemical hazards and when you may want to consider those hazards.  While it does not provide complete information on each of the hazards, it does provide some additional information.
  • Chapter 4 overviews the preventive controls - Process, Sanitation, Allergen, and Supply Chain controls - highlighting primary types for each.  Under Process Controls, the chapter covers leathality treatments (heat, HPP, irradiation, fumigation), cold holding, formulation control, etc.  Again, not a complete listing of types, but give information on the major types.
  • Chapter 5 is the application and management of preventive controls...provides some additional information to the preventive controls discussed in chapter 4.
Each of the coming chapters will expand upon the preventive controls as was done in Chapter 6 for heat processing.

This will become more of a companion reference document as examples of the process controls are expanded upon.  This guidance will give information on the types of things an FDA inspector will be looking for as they conduct inspections.  Certainly a document worth printing or bookmarking.  Be sure to watch for updated sections as they are released.