Happy New Year!

Best wishes for a Happy New Year filled with health, happiness, and spectacular success!

2017 Food Industry: 4 Trends to Watch

From a more connected supply chain to recall readiness, food companies can expect technology to play a larger role in the coming year.

From countless recalls, to FSMA deadlines, to the rising demand for transparency, 2016 has been a monumental year in the food industry. With 2017 knocking, here are the top trends and predictions to watch out for in the food industry next year.

1. Moving Toward a Fully Digital, Connected Supply Chain

The food supply chain in many ways is still lagging behind in technology compared to other supply chains. In 2017, many companies will begin or continue on their journey to fully digitize their supply chain, whether that is simply getting their list of approved suppliers out of an Excel spreadsheet and into a supplier management software technology solution or fully capturing every step of their products along the journey from farm to fork.

The spectrum of digitization across the supply chain is quite broad. But bottom line, supply chain analytics will empower food companies to create useful KPIs, allow them to truly measure the ROI of their supply chain initiatives and give consumers the transparency that they demand. And systems that fully support the daily monitoring, sharing and interpretation of those analytics needed to help companies will experience tremendous growth in 2017.

Collaboration with your supply chain partners is an absolutely critical element, and we can expect to see more companies fully integrate throughout their network of suppliers and customers. Food companies that will succeed in 2017 will need a fully integrated supply chain network, with access to the same information, working towards a shared mission to deliver results and be ahead of their competitors. A connected supplier network will allow food companies to be agile when faced with an issue, responsive to recalls, as well as be flexible and efficient.

2. Recalls, Recalls, Recalls

We saw a high volume of recalls this year, and this trend is not going away anytime soon. As more and more advances in food testing are made, companies will have access to new technologies across their supply chain that will identify issues early. Consequently, more products will need to be pulled out of the supply chain because of that increased testing in order to maintain consumer sentiment.

The companies that are able to roll out these capabilities quickly and efficiently—armed with the data needed—will be well poised to manage their supply chain, potential recalls and the impact to their customers. With the knowledge that we can expect to see several recalls in the new year, food companies should be looking to mitigate risks and better manage their supply chain.

3. Full-force FSMA Is Here Whether You Like It or Not

FSMA focuses on amplifying preventive controls for food production in order to alleviate potential food contamination outbreaks, and the past two or more years have been focused on this preparation. This preparation will come to a pinnacle in 2017, the first full year of FSMA implementation worldwide, with the FDA starting audits for larger companies. This could lead to the FDA requesting required records, conducting audits and in the worst situation for food companies, shutting down operations if they feel it’s necessary.

FSMA will require detailed record keeping when a recall or outbreak occurs, with clearly defined corrective actions in place. Companies will see an increased need for technologies that help supply preventive processes such as food allergen and sanitation controls, as well a prepared recall and supply chain plan. Tracking and traceability will be the two key parameters that will offer manufacturers the ability to examine specific foods and trends to improve their overall process. In order to comply with these new FSMA regulations at every step of the process, food companies will increasingly look to utilize these technologies to account for full traceability of the supply chain.

4. Growth in Foodservice At the Consumer’s Doorstep

Brands like Starbucks and Panera have been testing the food home delivery waters, but more companies seem to be jumping onto the trend of bringing gourmet food directly to the consumer’s doorstep—Blue Apron, Plated, HelloFresh just to name a few.

Article Source: FoodSafetyTech.com

Merry Christmas!

This season, may you be blessed with laughter, peace, and love...

Merry Christmas and Happy Holidays!

FSPCA Preventive Controls For Human Food February Class - Early Bird Ends January 20th

FSPCA Preventive Controls For Human Food

February 1, 2017 - February 3, 2017

Register HERE

3 sessions

#1. 01 Feb 2017, 8:00 AM 5:00 PM (PST)

#2. 02 Feb 2017, 8:00 AM 5:00 PM (PST)

#3. 03 Feb 2017, 8:00 AM 12:00 PM (PST)

Location

Hampton Inn & Suites Napa, 945 Hartle Court, Napa, CA 94559

Registration

1-4 Attendees Early Bird Ends Jan 20th - Save $60 per attendee – $790.00 (USD) Registration code required Registration is for 1 attendee, additional guests/attendees can be added during the registration process.

5+ Attendees Early Bird Ends Jan 20th- Save $110 per attendee – $740.00 (USD) Early Bird discount for 5+ only available for attendees from same company.

The FSPCA training materials are designed to meet the requirements for training under Title 21 Code of Federal Regulations Part 117.155 for the Preventive Controls “Qualified Individual” who conducts Food Safety Plan activities such as developing and reviewing a food safety plan, validating preventive controls, verifying and validating process controls among others. Attending an FSPCA course will provide assurances that the course content and resulting knowledge is consistent with regulatory expectations. Each facility registered with the FDA is required to have a Preventive Control Qualified Individual PCQI.

A preventive controls qualified individual is a person who has successfully completed training in the development and application of risk-based preventive controls at least equivalent to that received under the standardized curriculum from FSPCA.

The FSPCA program is based on collaboration among federal and state regulatory officials (FDA), academic food safety researchers and educators, and U.S. food industry representatives. This program is delivered by a FSPCA Lead Instructor.

This course meets the Preventive Controls Qualified Individual Training requirements. The participants will receive FSPCA Preventive Controls Qualified Individual certificate issued by AFDO.

Includes: Morning and afternoon snack breaks, Lunch, Course Materials and Certificate of Attendance.

Parking – Free parking

Hotel Booking - Hampton Inn & Suites 707-690-3075

REGISTRATION closes, no refunds will be given after January 30. Registrations may be transferred to another person from the same organization for the scheduled class. Cancellation fee before January 30, 2017 $250.00

Superior Food Safety Training Classes

WE OFFER THE FOLLOWING TRAINING CLASSES:

HACCP Workshop 

Implementing SQF Training - Version 7.2 - English and Spanish

FSMA Preventive Controls for Human Foods

Internal and External Audits

Crisis Management

Gluten Free Certification Program

Prerequisite Programs

  

Please visit our website or send us an email  for more information!

Five Errors That Impact GFSI Compliance

By Jason Dea

The Global Food Safety Initiative (GFSI) is a global initiative for the continuous improvement of food safety management systems. From a functional standpoint, you might be surprised to learn that one of the most challenging elements of keeping up with GFSI compliance for many food producers is sufficient document control. In fact, data compiled by SQF shows that document control-related issues are one of the most common sources of a non-conformance during GFSI-benchmarked audits. Examples of these non-conformances are associated with documentation of training requirements, business continuity planning, and corrective and preventative actions.

The Global Food Safety Initiative (GFSI) is an industry-driven initiative providing thought leadership and guidance on food safety management systems necessary for safety along the supply chain. This work is accomplished through collaboration between the world’s leading food safety experts from retail, manufacturing and food service companies, as well as international organizations, governments, academia and service providers to the global food industry. They meet together at technical working group and stakeholder meetings, conferences and regional events to share knowledge and promote a harmonized approach to managing food safety across the industry. GFSI is facilitated by The Consumer Goods Forum (CGF), a global, parity-based industry network, driven by its members.

So what exactly are some of the most common causes for document control issues as it relates to non-conformances? Keep an eye out for the following five errors that can affect compliance.

1. Lack of document control altogether
Lack of correct usage of document control in the context of GFSI compliance is a common error. This is an issue that often occurs as a result of document sprawl—specifically as it pertains to duplicate documents and supporting documents. For example, an organization might create internal reference material designed to be cheat sheets or summaries of larger policies. These could include simple charts that list key equipment set-up parameters or charts summarizing abbreviated information from product specification sheets. Many organizations fail to realize that because of the nature of the information in these files, these reference documents must also be included in their document control program to ensure that the information in them is current and universally applied.

2. Document version control
From using outdated forms to referencing outdated employee procedures, lack of proper document version control and enforcement is the most common GFSI compliance-related non-conformance. These issues can arise from operational errors (employees don’t know where to find up-to-date documentation or how to ensure that it is being used) to technical errors (the document control system is unable to properly manage document versioning, or in the case of home-grown document control software systems, they may be unable to do so altogether). To avoid these errors, it’s necessary to establish where controlled versions of documents are located and ensure that they are kept up to date. It’s also important remove obsolete versions of these documents—this is a basic principle of document control, but it’s often an area where errors compound over time. Reinforcing training so employees are made aware of document control best practices and policies is critical to keeping your compliance activities current.

3. Document revision errors
One of the most common activities and most common sources of error within any document control program involves publishing revisions to documents. These errors include:

• Updating the contents of a document but forgetting to update information such as the version number
• Improper tracking of revision history
• Adding new documents to the database rather than revising or updating existing documents

4. Inclusion of documents from external sources
If your food safety management system includes or makes use of external documents, these must be controlled in the same manner in which you control internal documents.

Some examples of external documents that may need to be included in your document control program include:

• Sample labels provided by your chemical and pest management suppliers
• Raw material specifications provided by your suppliers
• Customer expectations manuals provided by your customers

5. Improper identification of approval personnel
A best practice of document control is for the person knowledgeable about the content of a document to be assigned the responsibility of approving updates to it. In many organizations, this is interpreted to mean that all approval responsibilities are assigned to a single person across the organization. This could be the food safety coordinator or the document control administrator, despite the fact that it is not reasonable for a single person to be knowledgeable about all the procedures across the organization.

A better approach to approval responsibilities is to identify individuals who can be responsible for authorizing changes based on function or discipline. By spreading the responsibilities across more people, your document control program is more likely to be current and accurate.

When it comes to food safety compliance and best practices, particularly as they relate to GFSI, it’s often the basic principles that get overlooked once your organizations processes and systems are up and running. Setting up a process for document control and maintaining this process over time is a key to achieving and maintaining compliance. As such, it’s important to revisit your controlled document process and library regularly to ensure things are operating as designed and avoid costly compliance surprises at the same time.

Article Source: https://foodsafetytech.com/feature_article/five-errors-impact-gfsi-compliance/

FSPCA Preventive Controls For Human Food February Class - Early Bird Ends January 20th

FSPCA Preventive Controls For Human Food

February 1, 2017 - February 3, 2017

Register HERE

3 sessions

#1. 01 Feb 2017, 8:00 AM 5:00 PM (PST)

#2. 02 Feb 2017, 8:00 AM 5:00 PM (PST)

#3. 03 Feb 2017, 8:00 AM 12:00 PM (PST)

Location

Hampton Inn & Suites Napa, 945 Hartle Court, Napa, CA 94559

Registration

1-4 Attendees Early Bird Ends Jan 20th - Save $60 per attendee – $790.00 (USD) Registration code required Registration is for 1 attendee, additional guests/attendees can be added during the registration process.

5+ Attendees Early Bird Ends Jan 20th- Save $110 per attendee – $740.00 (USD) Early Bird discount for 5+ only available for attendees from same company.

The FSPCA training materials are designed to meet the requirements for training under Title 21 Code of Federal Regulations Part 117.155 for the Preventive Controls “Qualified Individual” who conducts Food Safety Plan activities such as developing and reviewing a food safety plan, validating preventive controls, verifying and validating process controls among others. Attending an FSPCA course will provide assurances that the course content and resulting knowledge is consistent with regulatory expectations. Each facility registered with the FDA is required to have a Preventive Control Qualified Individual PCQI.

A preventive controls qualified individual is a person who has successfully completed training in the development and application of risk-based preventive controls at least equivalent to that received under the standardized curriculum from FSPCA.

The FSPCA program is based on collaboration among federal and state regulatory officials (FDA), academic food safety researchers and educators, and U.S. food industry representatives. This program is delivered by a FSPCA Lead Instructor.

This course meets the Preventive Controls Qualified Individual Training requirements. The participants will receive FSPCA Preventive Controls Qualified Individual certificate issued by AFDO.

Includes: Morning and afternoon snack breaks, Lunch, Course Materials and Certificate of Attendance.

Parking – Free parking

Hotel Booking - Hampton Inn & Suites 707-690-3075

REGISTRATION closes , no refunds will be given after January 30. Registrations may be transferred to another person from the same organization for the scheduled class. Cancellation fee before January30/2017 $250.00

Santa Train, A Magical Night Awaits

The Napa Valley Wine Train celebrates the return of the Santa Train.

Guests will embark on an all new musical and interactive journey to Santa's Workshop accompanied by some of Santa's best friends. Magical wristbands will transform the experience, while guests enjoy hot chocolate, and a cookie.

Reservations are currently being accepted by calling 800-427-4124

FSPCA Queretaro, MX

 

Les Invita a Participar en el Curso Taller en QUERETARO, MX

Diciembre 13, 14 y 15 del 2016

FSPCA CONTROLES PREVENTIVOS 

DE ALIMENTOS PARA HUMANOS

Clase oficial y certificado omitido por FSPCA

PROGRAMA OFICIAL PARA LA INDUSTRIA DE

ALIMENTOS Y EXPORTADORES

•  2 días y medio de Capacitación
• Diciembre 13 de 9am-6pm
• Diciembre 14 de 9am a 6pm
• Diciembre 15 de 8am-12pm

QUERETARO, MX

Mencionar Superior Food Safety para recibir la tarifahabitación/noche.

Direccion: Luis Vega y Monroy 410, Querétaro, Querétaro, 76030

MéxicoTeléfono: 442-368-3000

 Register  HERE

There's Still Time to Register for Our December Class!

FSPCA Preventive Controls For Human Food

December 7th - December 9th, 2016

Register HERE

3 sessions

#1. Dec 7th, 2016, 8:00 AM – 5:00 PM (PST)

#2. Dec 8th, 2016, 8:00 AM – 5:00 PM (PST)

#3. Dec 9th, 2016, 8:00 AM – 12:00 PM (PST)

Location

Hampton Inn & Suites Napa, 945 Hartle Court, Napa, CA 94559

Registration

1-4 Attendees - $850.00 (USD) Registration is for 1 attendee, addtional guests/attendess can be added during the registration process.

5+ Attendees - Save $60 per attendee – $790.00 (USD) Early Bird discount for 5+ only available for attendees from same company.

The FSPCA training materials are designed to meet the requirements for training under Title 21 Code of Federal Regulations Part 117.155 for the Preventive Controls “Qualified Individual” who conducts Food Safety Plan activities such as developing and reviewing a food safety plan, validating preventive controls, verifying and validating process controls among others. Attending an FSPCA course will provide assurances that the course content and resulting knowledge is consistent with regulatory expectations. Each facility registered with the FDA is required to have a Preventive Control Qualified Individual PCQI.

A preventive controls qualified individual is a person who has successfully completed training in the development and application of risk-based preventive controls at least equivalent to that received under the standardized curriculum from FSPCA.

The FSPCA program is based on collaboration among federal and state regulatory officials (FDA), academic food safety researchers and educators, and U.S. food industry representatives. This program is delivered by a FSPCA Lead Instructor.

This course meets the Preventive Controls Qualified Individual Training requirements. The participants will receive FSPCA Preventive Controls Qualified Individual certificate issued by AFDO.

Includes: Morning and afternoon snack breaks, Lunch, Course Materials and Certificate of Attendance.

Parking – Free parking

Hotel Booking - Hampton Inn & Suites 707-690-3075

REGISTRATION CLOSES ON December 6, no refunds will be given after October 30. Registrations may be transferred to another person from the same organization for the scheduled class.

Top 3 Reasons For Food Recalls

Prevent the devastating effects that recalls can have on your business.

Recalls are an inevitable reality of working in the food industry. Indeed, hardly a day goes by without one food company or another announcing a recall. According to the USDA, 150 food products were recalled in 2015. From large national brands like Tyson Foods and McCormick to smaller local manufacturers, no food company is immune from recalls.

Recovering from the sometimes devastatingly expensive recall process can be difficult, so it’s obviously best to avoid problems whenever possible. Understanding the top three reasons for food recalls is the first step toward greatly reducing how frequently they affect your food company.

1. Cross Contamination

Many food manufacturers process multiple products in a single factory. This can lead to cross-contamination issues involving foods to which people are commonly allergic, namely milk, wheat, soy and peanuts. Because cross contamination is sometimes unavoidable, manufacturers are permitted to sell cross-contaminated food, provided the potential contaminants are declared as allergens on the label. According to the USDA’s report, undeclared allergens accounted for 58 of the 150 food recalls in 2015, and milk has been identified as the number one offender.

How to Prevent Cross Contamination. Food is often contaminated because machinery isn’t properly cleaned between uses. Therefore, the most effective way to prevent it is to thoroughly clean equipment after processing food that contains common allergens. Visually inspecting the equipment following cleaning is important, but unseen residue can linger.

To overcome this, in-plant allergen testing of equipment, post cleaning, is recommended. Some tests utilize quick, non-allergen-specific colorimetric tests to identify sugars, proteins and other indicators that an allergen is present. More expensive enzyme-linked immunosorbent assay (ELISA) kits are more sophisticated and may be a better choice if cross contamination plagues your food manufacturing plant.

• Other tips to prevent a recall caused by allergen contamination include:
• Establishing spill-cleanup protocols
• Training personnel on allergen management
• Designing equipment with sanitary principles in mind, including self-draining equipment, smooth edges and rounded corners
• Carefully inspecting product labels for accuracy

2. Pathogens

Recalls from pathogen-contaminated products are highly damaging because they affect all consumers, not just those with specific allergies. Listeria, E. coli and Salmonella are the most common—resulting in a combined 17 food recalls in 2015, according to the USDA’s report. Several foods have been identified as being most at risk for carrying these pathogens:

• Deli meats, soft cheeses and other foods that usually aren’t cooked
• Poultry, eggs, undercooked beef, and unpasteurized milk or juice
• Raw fruits and vegetables
• Raw or undercooked shellfish
• Home-canned foods with low-acid content — including asparagus, corn, green beans and beets

How to Prevent Pathogens. As with avoiding cross contamination, the best way to prevent a pathogen outbreak is to implement hygienic manufacturing practices. Four specific techniques apply here:

• Separate raw products from cooked/ready-to-eat products. Your efforts should even go as far as separating employees who work in each area. They should use divided washing facilities, locker rooms and cafeterias.
• Control the temperature and moisture level to reduce bacteria and mold growth. Anywhere condensation forms or moisture is left to pool, micro-organisms can potentially grow and create a contamination issue. Ventilation and air conditioning can help tremendously with this, as can air dryers used to sap moisture from steamy air.
• Implement pest-control techniques. Rats, flies and cockroaches are significant carriers of Listeria, Salmonella, Vibrio cholera and other bacteria. Effective pest-control techniques include disposing of garbage properly, sealing pest entry points, and using air curtains and screens to keep flies out.
• Choose durable, easily cleanable equipment for your manufacturing plant and wash all surfaces regularly. Mold and bacteria can start growing within a matter of hours, so keeping surfaces clean is essential. Proper hygiene among plant personnel is critical as well.

3. Physical Contamination

When non-food items are found in food products, a recall is inevitable. Metal, plastic, wood and even insect body parts are examples of physical contaminants. Food is also considered physically contaminated if it’s chemically or biologically tainted. According to a Food Standards Agency report, of the 107 physical contamination incidents in 2012, the most common malefactors were metal (37), pests (23) and plastic/glass (10 each).

How to Prevent Physical Contamination. Foreign objects often enter food products when malfunctioning equipment or human error breaks down the production process. Safeguards such as X-ray scanning, metal detection and filtration/sieving processes help catch foreign objects before they’re shipped, but these aren’t foolproof methods. You should also only work with trustworthy suppliers and take the time to examine raw materials before using them.

The general public expects food manufacturers to produce safe, untainted food. By following these tips, you help uphold your brand and avoid the expensive, reputation-damaging effects of food recalls.

Article Source: FoodSafetyTech.com

FSPCA Queretaro, MX

 

Les Invita a Participar en el Curso Taller en QUERETARO, MX

Diciembre 13, 14 y 15 del 2016

FSPCA CONTROLES PREVENTIVOS 

DE ALIMENTOS PARA HUMANOS

Clase oficial y certificado omitido por FSPCA

PROGRAMA OFICIAL PARA LA INDUSTRIA DE

ALIMENTOS Y EXPORTADORES

•  2 días y medio de Capacitación
• Diciembre 13 de 9am-6pm
• Diciembre 14 de 9am a 6pm
• Diciembre 15 de 8am-12pm

QUERETARO, MX

Mencionar Superior Food Safety para recibir la tarifahabitación/noche.

Direccion: Luis Vega y Monroy 410, Querétaro, Querétaro, 76030

MéxicoTeléfono: 442-368-3000

 Register  HERE

Sign Up for December Classes

FSPCA Preventive Controls For Human Food

December 7th - December 9th, 2016

Register HERE

3 sessions

#1. Dec 7th, 2016, 8:00 AM – 5:00 PM (PST)

#2. Dec 8th, 2016, 8:00 AM – 5:00 PM (PST)

#3. Dec 9th, 2016, 8:00 AM – 12:00 PM (PST)

Location

Hampton Inn & Suites Napa, 945 Hartle Court, Napa, CA 94559

Registration

1-4 Attendees - $850.00 (USD) Registration is for 1 attendee, addtional guests/attendess can be added during the registration process.

5+ Attendees - Save $60 per attendee – $790.00 (USD) Early Bird discount for 5+ only available for attendees from same company.

The FSPCA training materials are designed to meet the requirements for training under Title 21 Code of Federal Regulations Part 117.155 for the Preventive Controls “Qualified Individual” who conducts Food Safety Plan activities such as developing and reviewing a food safety plan, validating preventive controls, verifying and validating process controls among others. Attending an FSPCA course will provide assurances that the course content and resulting knowledge is consistent with regulatory expectations. Each facility registered with the FDA is required to have a Preventive Control Qualified Individual PCQI.

A preventive controls qualified individual is a person who has successfully completed training in the development and application of risk-based preventive controls at least equivalent to that received under the standardized curriculum from FSPCA.

The FSPCA program is based on collaboration among federal and state regulatory officials (FDA), academic food safety researchers and educators, and U.S. food industry representatives. This program is delivered by a FSPCA Lead Instructor.

This course meets the Preventive Controls Qualified Individual Training requirements. The participants will receive FSPCA Preventive Controls Qualified Individual certificate issued by AFDO.

Includes: Morning and afternoon snack breaks, Lunch, Course Materials and Certificate of Attendance.

Parking – Free parking

Hotel Booking - Hampton Inn & Suites 707-690-3075

REGISTRATION CLOSES ON December 6, no refunds will be given after October 30. Registrations may be transferred to another person from the same organization for the scheduled class.

December Holiday Events In Napa Ca

Carriage Rides - Thursdays, Dec. 8, 15, and 22 

4:30 to 7:30 PM 

Enjoy free horse drawn carriage rides through downtown Napa. It's one of the best ways to enjoy the Holiday lights on all the buildings and check out the Christmas windows, while snuggling with family. Carriages depart every fifteen minutes from the Napa River Inn at the Hatt Building on Main Street. Spend the time between rides shopping and dining in beautiful downtown Napa. Thanks to the 20/30 Club for their support with the rides.

Lots of holiday events are being celebrated! See all of them here!

DOJ: Respect The Law Or Fear It

It doesn’t take a great deal of reading or research to see that there has been a marked rise in Department of Justice (DOJ) activity in the food industry over the last few years. In fact, the DOJ’s Principal Deputy Assistant Attorney General Benjamin Mizer spoke at a food policy conference in April on that very topic, discussing DOJ’s role in ensuring the safety of the food supply, and the enforcement tools it has to fulfill that role.

As Mizer stated, “One of the government’s highest obligations is to protect citizens when they cannot protect themselves.” Because consumers have to rely on the companies who manufacture and distribute food to ensure that the food they buy is safe, the government sees food safety as an area in which consumers cannot always protect themselves, so it has an obligation to assist in providing that protection.

Such protection is also the very foundation of the Food Safety Modernization Act (FSMA) and its risk-based preventive controls, and DOJ, FDA, and USDA have been acting on that obligation not only in increasing frequency, but in increasingly severe ways, i.e., the 20+-year prison sentences of the PCA executives. And, as I wrote in a recent newsletter (How Serious is the Department of Justice?) which I will recap a bit in this article, my view is that this is very serious business, and it is a trend that I don’t expect to slow down any time soon.

“Back up a minute,” you may be thinking. “What about all the work we’ve done for FSMA compliance? Won’t that get us off the DOJ hook?”

WILL FSMA PROTECT YOU? Yes. And no. If you are truly and completely following FSMA, including its inference to build a food safety culture into your organization which is followed from the top down, you will have gone a long way in the prevention of the contamination or adulteration of your product which will, as a result, go a long way in the prevention of an investigation by FDA or DOJ. (Former FDA Deputy Commissioner for Foods and Veterinary Medicine Michael Taylor specifically discussed the relationship between FSMA and a food safety culture in FDA: Culture Is a Preventive Control, QA May/June 2015.)

But we all know that no one and nothing is perfect; no one expects that FSMA will eliminate all contamination and foodborne illness. But what you may not know or fully appreciate is that Congress made it a prohibited act to introduce adulterated food into interstate commerce; and it is a strict liability offense, meaning that a company or individual who violates the law can face misdemeanor charges – whether or not it intended to distribute adulterated food.

Additionally, in FDA’s Regulatory Inspection Manual under section 6.5 “Prosecutions,” FDA made it very clear that it sees prosecutions as beneficial to food safety as having a deterrent effect. Specifically, the document states: “Misdemeanor prosecutions, particularly those against responsible corporate officials, can have a strong deterrent effect on the defendants and other regulated entities.” It’s essentially the same tactic that is taken by parents around the world. Threats are only as good as their corresponding action: if a rule is broken and the guilty child faces no repercussions, every other sibling will see the rule as nonbinding. But if punishment is meted out to a degree that befits each violation, it not only impacts the reprimanded child, but also each sibling who sees that the parent is serious.

Though the prosecution meted out by FDA is, of course, much more serious, it follows the same philosophy: Let the corporate executives see that we are serious; let them see that we will prosecute; and it will put the fear into them. As I heard one father say many times, “My children will either respect me or fear me.” If the only way a child/some food corporations will follow the rules is the fear of punishment/prosecution, then so be it.

The analogy can be taken even a step further: Recall a time that you were with a younger child (whether it was a sibling; a niece, nephew, a child you were babysitting, etc.) whose actions caused harm – broke an item, hurt another child, etc. Wasn’t the first question, “Why weren’t you watching him/her better?” or “You should have known, you were in charge!” or simply “Who’s older?” (i.e., “Who’s the boss?”) In the same way, any process that takes place in the food facility; any harm that is caused by a person or action; any contamination that began anywhere along the food chain will be considered to be the responsibility of the corporate executives, because as executives, it is their job to know, to ensure practices are in place and are being followed. They are “in charge.”

AN INCREASED FOCUS. And FDA is checking. With the advanced detection of whole genome sequencing; its “long memory” (ability to match a bacteria found in a facility today with one found four years ago – or longer); its linkage in CDC’s national database; and the FDA inspectors’ current propensity to undertake a “swabathon” in food manufacturing facilities – we are beginning to see more and more situations where a case or two of listeriosis is being linked back to a food production facility. What all this means is that it is much easier today to link a sick human with a suspect food and food plant. Thus, the odds that you will be found to have put adulterated food into commerce – even if totally without intent – continue to rise.

Further, if FDA then finds that you have had positive hits with Listeria but not taken appropriate corrective actions and root cause analysis, you can end up with the DOJ coming to visit. So, not only is FDA conducting microbiological profiling during facility inspections and testing food at retail, it is acting on its right to initiate criminal investigations against food companies and their executives who distribute food products that have the potential to cause human illness – even when the executives had no direct knowledge of the potential.

Although there is certainly an increase in criminal investigations and DOJ prosecutions, it is not a new tool for the agency. Rather, it dates back to a 1975 Supreme Court decision from which the Park Doctrine established that a responsible corporate official can be held liable for a first-time misdemeanor (and possible subsequent felony) under the FD&C Act without proof that the corporate official acted with intent or even negligence, and even if such corporate official did not have any actual knowledge of, or participation in, the specific offense.

You, obviously, will have noticed by now that I have repeatedly stated that one can be prosecuted and held liable even without knowledge or intent. In fact, it has been stated so often, you may be wondering if I actually reread my own columns before submitting them. But understand that my repetition is quite purposeful. There is an ancient legal principle that states, “Ignorance of the law is no excuse.” That is, even if you do not know that something is against the law, you can still be punished for doing it. The same holds true here – even if you don’t know that something occurred, or could occur, you can still be punished for it.

To see that this is true, simply consider Jensen Farms – which contended that it had relied on a Superior audit rating and didn’t know their operation was flawed, yet they were sentenced to probation, home detention, and a fine. You may also want to keep an eye on the current criminal investigations of Bluebell, Dole, and others for 2015 outbreaks.

DOJ “TOOLS.” Back in the first paragraph of this article I noted that Mizer’s statement included the fact that DOJ is not only focused on ensuring the safety of the food supply, it also has the enforcement tools to do so. What exactly are these “tools”? What sorts of punishment might a corporate executive (or others) face?

First, it is important to understand that DOJ relies on FDA, USDA, and CDC for “their technical expertise, their investigative support and their deep knowledge of the industries they regulate as keys to building cases,” and that the FD&C provides DOJ with both criminal and civil authorities, with that decision based on the evidence and applicability. Following is some of the detail Mizer provided about these tools:

• Civil Authority. The civil authority is primarily designed to prevent the distribution of adulterated food, such as asking a court to order the seizure of potentially unsafe products or to temporarily prevent a facility from operating until sanitary conditions are established.  In these cases, which are often resolved through negotiated agreement, the goal is to require that the company institute new health and safety procedures and that it not be able to distribute food until the government can verify that it has taken all steps necessary to prevent a recurrence.  Civil enforcement is often used in cases of unsanitary conditions and has also been used for those involving the administration of drugs/antibiotics to animals intended for human consumption.
Civil cases make up the majority of the food safety actions brought by DOJ. “But,” Mizer said, “sometimes it’s important that we hold criminally accountable those individuals and entities that place consumers at risk by putting unsafe food on our table and in our lunchboxes. That way we make clear to people in the industry that they have a responsibility to protect the safety of the public.”
• Criminal Prosecution. When DOJ decides that criminal prosecution is warranted, based on such things as the nature and seriousness of the offense, the deterrent effect of the prosecution, and the culpability of the individuals or entities involved, it must then decide whether to bring misdemeanor or felony charges. Even if DOJ elects to charge a violation as a misdemeanor, it can still bring serious penalties, such as the misdemeanor sentences of the Iowa egg farm owner and CEO of three months in prison, one year of supervised release, and a $100,000 fine. Felony charges will be brought when the facts become egregious enough to warrant that, such as when DOJ can show an intent to defraud or to mislead consumers or the FDA.

What makes these prosecutions of further consequence is that, under the Park Doctrine, once a person has been convicted of a misdemeanor under FD&C, any subsequent violation is an automatic felony, even, again, without proof that the defendant acted with the intent to defraud or mislead.

So, to jump back to the question: Will FSMA get you off the DOJ’s hook? Yes and no. But full implementation of FSMA and the involvement of everyone in the organization will certainly help in prevention, and in providing at least some defense if a contamination does occur. FSMA is serious stuff for sure, but this new trend from DOJ and FDA should be taken very seriously, and every executive in a company involved with food should be aware of the trend and act accordingly.

David Acheson is Founder and CEO, The Acheson Group.

Article Source: http://magazine.qualityassurancemag.com/article/july-2016/doj-respect-the-law-or-fear-it-july-2016.aspx