,

How a Government Shutdown Affects Your Food Safety

A government shutdown looms on today’s horizon

January 19, 2018. There are many federal agencies working for the American people on food safety. Three examples are the Centers for Disease Control and Prevention (CDC) is responsible for monitoring public health, identifying outbreaks, and investigating the source of outbreaks. The Food and Drug Administration (FDA) publishes and enforces laws and guidance for ingredient suppliers and food manufacturers and inspects food companies for compliance with the Food Safety Modernization Act (FSMA) and Good Manufacturing Practices (GMPs). The United States Department of Agriculture (USDA) has parallel duties in food safety to FDA. USDA has jurisdiction over animal products, and FDA gets all the other foods.

CDC. The US is currently in an outbreak of Listeria monocytogenes from potentially from Romaine lettuce. CDC is working closely with Canada, where the outbreak was first identified. There have been deaths. South Africa is currently investigating the largest outbreak of Listeria monocytogenes the world has ever seen. When last I saw, there have been 67 deaths. CDC personnel are certainly in communication with health officials in South Africa to monitor the outbreak and collaborate with food safety officials. Then there is flu season. CDC is responsible for monitoring the cases and number of deaths to track the impact of the flu. With a government shutdown, these non-essential duties and communication may cease, putting millions of Americans in harm.

FDA. FSMA has six laws currently under enforcement. Both the food industry and FDA have been ramping up compliance to the laws. FDA inspectors have been trained and are out doing FSMA inspections. FDA inspections where a user fee is levied will continue. FDA posts recalls daily. With a government shutdown, will recalls be deemed essential duties for the FDA? Will the recalls be announced? Will FDA arrive at the food factory to investigate? Will FDA meetings on recalls be postponed?

USDA. One significant difference between FDA and USDA is that animal slaughter, with subsequent meat packing operations, has mandatory supervision by a USDA inspector. Without the USDA inspector, there is no animal slaughter.

For more details on the affect of a shutdown, go to this PBS article.

Still have questions? The ConnectFood website has free resources, and the folks at ConnectFood are here to help! Contact Us

Kathy Knutson, Ph.D.
Kathy Knutson Food Safety Consulting

Dr. Kathy Knutson works nationwide with food manufacturers on recall investigations, problem-solving, training, and Food and Drug Administration (FDA) compliance. After being trained in 2016 as a Lead Instructor with the FDA-recognized curriculum for Preventive Controls Qualified Individuals, she delivered over 20 workshops to industry. With over 35 years in microbiology and 15 years of full-time teaching, Dr. Knutson is passionate about training and is an effective communicator at all levels in an organization. She has taught and consulted with companies on laboratory methods, interpretation of lab results, quality assurance, sanitation, environmental monitoring, Standard Operating Procedures (SOPs), Good Manufacturing Practices (GMPs), Hazard Analysis and Critical Control Points (HACCP) and the FDA’s Food Safety Modernization Act (FSMA). As a life-long learner, Dr. Knutson is trained in prevention of intentional adulteration, a topic on the horizon for the food industry. Dr. Knutson is a contributing author at CannabisIndustryJournal.com. Dr. Knutson writes a food safety blog and contributes expert services to manufacturers through ConnectFood.com, an online site for writing HACCP and food safety plans. When Dr. Knutson is not traveling, she works from home in Green Bay, Wisconsin, where she lives with her husband, two sons, and an adorable Bernedoodle. Learn more about her at https://www.linkedin.com/in/kathyknutsonphd

,

How do I Add Radiological Hazards into My Food Safety Plan?

Radiological hazards are chemical hazards.
Radioactive chemicals emit harmful radiation that at large doses is harmful soon after exposure and at small doses is harmful years or decades later. Our food may become contaminated through the absorption of radioactive chemicals found in soil or water. Radioactive chemicals in air may settle onto food, water, or soil. Terms used to describe radioactive chemicals include: radioactive isotopes, radioactive elements, and radionuclides. Examples include: radioactive cesium, uranium, and strontium.

You may be familiar with radon testing before purchase of a home; this is standard practice in real estate. I was at the house we were purchasing when the radon test was done – it was a beautiful day, but I could not open the windows or the test would be invalid. Radon is a gas. When a radon test is done inside a house, the air is tested for a given time. (Our house passed the radon test.) Radon is not a chemical hazard of major concern in the food industry.

Radioactive chemicals are naturally present in some rock formations. As rainwater filters through soil and is collected in aquifers below the surface, the water may pick up radioactive chemicals. If your facility uses well water, research the location of the aquifer. What is known about the soil and rock formation surrounding the aquifer? Is the location known to have a risk of radioactive chemicals? If your facility uses municipal water, your water treatment facility tests for radioactive chemicals. Add your annual water report from your water treatment facility to your food safety plan. If you have questions on the report, talk with your local water treatment facility.

When you write your hazard analysis, include radiological hazard as a chemical hazard once for your water supply.
In the hazard analysis you may determine that the hazard does not require a preventive control and will remain as a Good Manufacturing Practice for potable water.

Approve suppliers using your own criteria.
If ingredients for your product include a crop, you may have concerns about the location of the field and water used for irrigation. Theoretically, there could be an uptake of radioactive chemicals if present in the soil or if present in the water used for irrigation. Know the location for the crop and communicate with your supplier if you have any concerns.

Radioactive chemicals are of concern after nuclear power plant accidents. In the 1986 Chernobyl nuclear power plant accident in what is now the Ukraine, plumes of radioactive material were sent into the air in updrafts from a steam explosion and resulting fire. The radioactive material settled into the surrounding area as the wind blew away from the facility. In the 2011 Fukushima nuclear power plant accident in Japan, a tsunami hit the coast. Loss of electricity to cooling pumps caused a reactor meltdown, explosions, and release of radioactive material to the air, ground water, and the Pacific Ocean.

What can you do about the potential for a nuclear power plant accident near you? First, locate the nearest nuclear power plant to your facility. The website for the Nuclear Regulatory Commission has a feature for locating nuclear power plants. Second, determine if you are within an emergency planning zone and review the plume exposure pathway. If your facility is within 50 miles of a nuclear power plant and an accident occurs, there is a ban of contaminated water and food.

When you write your hazard analysis, include radiological hazard as a chemical hazard for your location.
If your facility is within 50 miles of a nuclear power plant, identify a hazard requiring a preventive control and write an emergency plan. Being prepared for an emergency is the best insurance that it won’t happen.

Please comment on this blog post below. I love feedback! Still have questions? The ConnectFood website has free resources, and the folks at ConnectFood are here to help! Contact us.

Kathy Knutson, Ph.D., Lead Instructor for Preventive Controls for Human Food (PCHF), Preventive Controls Qualified Individual (PCQI), and trained in prevention of Intentional Adulteration (IA). She has food safety expertise in microbiology, hazard analysis, and risk assessment. As a recovering academic, she resides in Green Bay home-of-the-Packers, Wisconsin with her brilliant husband and two handsome sons. Learn more about her consulting services at https://www.linkedin.com/in/kathyknutsonphd.

What I Learned from an FDA Seafood Guidance

I was on a flight to Boston, and in my hand was the FDA draft guidance, Seafood HACCP and the FDA Food Safety Modernization Act: Guidance for Industry. HACCP is hazard analysis and critical control points, and the Seafood HACCP rule was published in 1995. I had received the FDA guidance document at the previous Preventive Controls for Human Food (PCHF) workshop that I taught in Seattle. In Seattle, I had several workshop participants who worked in the seafood industry. I had dined on delicious salmon in Seattle and was dreaming of eating fresh seafood in Boston.

A substantial difference between the Seattle workshop and the Boston workshop was that the Boston workshop was comprised of people from the milling and baking industry, not seafood. Darn. Seafood HACCP has a life of its own in regulation, and I was looking forward to learning more about seafood from the workshop participants. Reading the guidance would not further my expertise as a Lead Instructor for the Boston workshop, but nevertheless I was in the mood to read this compact document. As I skimmed the introductory material, I came to a nice question and answer (Q & A) format. The FDA always does a nice job of communicating important information through the format of Q & A. Sometimes it is just nice to see plain English from the FDA, and that’s what a Q & A provides.

I did learn some information specific to the seafood industry from the guidance document, but it was the general information from the Food Safety Modernization Act (FSMA) that piqued my interest. Do you know the following three facts?

    1. Training and training records are now required.
    FDA is making a big deal out of training. Every person employed in the manufacturing, processing, packing or holding of food must be trained in food safety. There must be training records kept for each individual showing the individual is a “qualified individual” to perform his or her job. Supervisors must have additional training to demonstrate they are qualified to do their job.

    Who organizes the training records at your facility? The inspector will ask to see training records of employees. The more organized your company is, the easier it will be to show these records to the inspector. Training records can be paper, electronic, or a combination. FDA is focusing on training, so be prepared.

    2. Written sanitation procedures are not required for GMPs.
    Subpart B of the PCHF rule is Good Manufacturing Practices (GMPs) and replaces GMPs found in 21 CFR 110. Subpart B does not require written sanitation procedures. This means that the chemical concentrations, equipment, times and temperatures for a cleaning or sanitizing procedure are not required to be written, but you should. See my previous blog post on Sanitation Standard Operating Procedures (SSOPs).

    The sanitation crew at most facilities has a lot of turnover and little supervision for an extremely important job. Writing the procedures will facilitate training, consistency and effectiveness of cleaning and sanitizing. Written monitoring procedures and corrective action records are required.

    3. Written sanitation procedures are required for sanitation preventive controls.
    In Subpart C of the PCHF rule, this is how the logic flows in the rule:

    1. A written food safety plan is required 21 CFR 117.126(a)(1).
    2. A food safety plan includes preventive controls 21 CFR 117.126(b)(2).
    3. Preventive controls must be written 21 CFR 117.135(b).
    4. Sanitation preventive controls are procedures, practices and processes 21 CFR 117.135(3).

Therefore, if a facility identifies a sanitation preventive control in the hazard analysis, written sanitation procedures are required.

If a facility has an allergen in one product, but not in another product from the same line, the facility will have a sanitation preventive control for the allergen clean procedure. If a facility produces a ready-to-eat product, the facility will have a sanitation preventive control for the cleaning and sanitizing procedure to control pathogens. Like Subpart B, written monitoring procedures and corrective action records are required.

Even with plain English, information can be confusing. When I am teaching the PCHF course, I warn the participants that the answer to a question may be, “You have to take that to legal.” I encourage you to visit the FSMA website and review FDA guidance documents. Boston was my 17th PCHF workshop, and I am still learning.

Please comment on this blog post below. I love feedback! Still have questions? The ConnectFood website has free resources, and the folks at ConnectFood are here to help! Contact us.

Kathy Knutson, Ph.D., Lead Instructor for Preventive Controls for Human Food (PCHF), Preventive Controls Qualified Individual (PCQI), and trained in prevention of Intentional Adulteration (IA). She has food safety expertise in microbiology, hazard analysis, and risk assessment. As a recovering academic, she resides in Green Bay home-of-the-Packers, Wisconsin with her brilliant husband and two handsome sons. Learn more about her consulting services at https://www.linkedin.com/in/kathyknutsonphd.

, , ,

What are Preventive Controls in the Food Industry?

Preventive controls are actions your company takes to ensure the product is safe. The FDA recognizes five types of preventive controls in the Preventive Controls for Human Food rule. They are process, allergen, sanitation, supply chain, and other preventive controls.

Food companies with more than $1 million in annual revenue are required under FSMA’s Preventive Controls for Human Food rule to conduct a hazard analysis and identify preventive controls. The company will consider biological, chemical, physical, and radiological hazards. The hazard analysis drives the discussion and decisions on preventive controls. For every hazard, there are actions the company takes to control the hazard.

Most food companies have a process preventive control and monitor time and temperature. The time and temperature are combined to control a biological hazard. Most companies have a metal detector, inspection of packaging to match the product and label allergens for an allergen preventive control, and monitoring of sanitation preventive controls for the control of environmental pathogens. FDA’s current thinking on environmental monitoring is detailed in the draft Listeria guidance. Process preventive controls and sanitation preventive controls may be designed to prevent foodborne illness, but did you know most recalls are due to the hazard of allergens? The food may be perfectly made, but if the packaging is wrong, the company will have a recall. Follow this link for just one example.

Some companies have so many redundant steps that it is difficult to name the step which is a preventive control. In this case, the food safety team should talk through their process and imagine taking away a step. I talked with a company that had multiple filters for their stream of product. To name every filter as a preventive control creates a lot of work and is unnecessary. Failure of the first filters was not a food safety issue because later filters work. The company visualized which filters were the most important for food safety by visualizing the removal of each individually. Where failure could result in a food safety hazard, the step was named as a preventive control.

If the hazard is controlled by the supplier, the receiving company must verify the hazard was controlled. An example is ice cream inclusions, like nuts. Imagine how the receiving company could verify the safety. COAs of course. Will the supplier share their food safety plan? An audit is required. Does the supplier have a validated process? Supply chain preventive controls are all about verification.

In addition to the four types of preventive controls mentioned above, the FDA also gives industry the option of other preventive control. I look at this type in two ways. First, your food safety team may disagree on naming the type of preventive control. For example, is an allergen clean a sanitation or allergen preventive control? It doesn’t matter! It only matters that it gets done. The second way that other can be used is if new scientific information emerges and does not fit into one of the four types of preventive controls. Current scientific understanding (below) means that we are always learning, and new information on hazards is always emerging. With the latest information, a company may need to reanalyze their food safety plan.

Here is the definition of preventive controls from the rule:

Preventive controls means those risk-based, reasonably appropriate procedures, practices, and processes that a person knowledgeable about the safe manufacturing, processing, packing, or holding of food would employ to significantly minimize or prevent the hazards identified under the hazard analysis that are consistent with the current scientific understanding of safe food manufacturing, processing, packing, or holding at the time of the analysis.”

The knowledgeable person ultimately is a Preventive Controls Qualified Individual (PCQI) in cooperation with engineers, microbiologists, and other food safety experts. The PCQI works with his or her food safety team to write the hazard analysis and identify preventive controls. The food industry has trained over 40,000 PCQIs in less than two years. PCQIs are your go-to people for food safety. If you are a small company in need of food safety expertise, the folks at ConnectFood are here to help.

Please comment on this blog post below. I love feedback! Still have questions? The ConnectFood website has free resources; click here to Contact us.

Kathy Knutson, Ph.D., Lead Instructor for Preventive Controls for Human Food (PCHF), Preventive Controls Qualified Individual (PCQI), and trained in prevention of Intentional Adulteration (IA). She has food safety expertise in microbiology, hazard analysis, and risk assessment. As a recovering academic, she resides in Green Bay home-of-the-Packers, Wisconsin with her brilliant husband and two handsome sons. Learn more about her consulting services at https://www.linkedin.com/in/kathyknutsonphd.

, ,

First Cold Brew Coffee Recall

As I sit drinking my Jamaican Me Crazy morning coffee, I open the newest FDA recall announcement, and it is for Death Wish Coffee’s Death Wish Nitro Cold Brew. First, that’s an unfortunate name given that the recall is for the potential of botulism which is deadly. Putting that aside, I have been waiting for the first recall or outbreak of cold brew coffee. I have been telling anyone who listens that it is only a matter of time before there is a recall or outbreak. The business of food safety is secure.

The beauty of coffee is that it is made with hot water. Most of us have seen on TV or, in some cases, in person the harvesting, gathering, and shipping of coffee beans. The process is nasty. Mud, birds, and rodents are intimately involved in the process. The beans are roasted, but microbiologists like to say, “dirt in, dirt out.” Some of us don’t say “dirt.” After the beans are roasted, they are ground. Have you ever ground beans at the grocery store? I bet that piece of equipment never gets cleaned. What about at commercial roasters? How often does the equipment get cleaned? Or at your gas station/ convenience store? You get the picture.

Again, the beauty of coffee is that it is made with hot water. Folks, this is a needed kill step. FDA recently gave us Chapter 6 of the Hazard Analysis and Risk-Based Preventive Controls for Human Food: Draft Guidance for Industry in draft form. Chapter 6 is Use of Heat Treatments as a Process Control. Every food manufacturer should review this guidance.

This recall of coffee is of canned cold brew coffee. There was no kill step for Clostridium botulinum, and there is the potential for botulism. The company is faced with the fact that they cannot can cold brew coffee without destroying the flavor profile. Smart on their part is to announce that they have suspended the production of this product. It is also smart to work with a process authority like ConnectFood CEO Matthew Botos. There are nonthermal ways to approach the manufacture and packaging of cold brew coffee. That will cost upward of a million dollars, so profit margin needs to be high.

This is what we do at ConnectFood. We support; we educate. Right now though, I need more coffee.

Please comment on this blog post below. I love feedback! Still have questions? The ConnectFood website has free resources, and the folks at ConnectFood are here to help! Contact us.

Kathy Knutson, Ph.D., Lead Instructor for Preventive Controls for Human Food (PCHF), Preventive Controls Qualified Individual (PCQI), and trained in prevention of Intentional Adulteration (IA). She has food safety expertise in microbiology, hazard analysis, and risk assessment. As a recovering academic, she resides in Green Bay home-of-the-Packers, Wisconsin with her brilliant husband and two handsome sons. Learn more about her consulting services at https://www.linkedin.com/in/kathyknutsonphd.

,

What Happens at Receiving Does Not Stay at Receiving

Receiving is a critical operation within your company with great responsibilities.

  1. Receiving of raw materials potentially contaminated with pathogens
  2. Receiving of ingredients with known allergens
  3. Receiving of ingredients or packaging with a supply chain preventive control
  4. Prevention of intentional adulteration

Receiving personnel need access to records at Receiving. Do Receiving personnel have a tablet or computer to look up approved suppliers, specifications and other information? Stickers and placards should be readily available to label totes or pallets with QA hold, allergen, or other warnings. Receiving personnel must be properly trained in the receipt, labeling and handling of raw materials potentially contaminated with pathogens, ingredients with allergens, and ingredients or packaging with a supply chain preventive control.

Written procedures are required for Receiving for ingredients with a supply chain preventive control.

The Preventive Controls for Human Food rule Subpart G details the requirements for supply chain preventive controls. With every receipt of an ingredient with a supply chain preventive control, bill of lading should be checked, along with the receipt of documentation of the absence of the hazard. The latter is needed, regardless of the same lot being repeated.

Receiving should have written SOPs for the inspection of vehicles for sanitary transport and receipt of materials in intact totes or on intact pallets. Not only are you concerned about determining if pests have accessed the ingredient, you are also preventing cross-contamination of pathogens and cross-contact of allergens. Within the written SOP, address the refusal of goods where the truck is unsanitary or when the packaging is compromised.

The Intentional Adulteration rule is effective in 2019, and Receiving plays a more direct role. Many of the steps taken now, like sealing of gaskets, will be documented to comply with the rule. The focus of the rule is on liquid ingredients and ingredients with the potential to cause widespread harm to public health. As you are implementing your food safety plans, consider incorporating measures designed to prevent intentional adulteration at Receiving.

Once an ingredient is accepted and properly labeled, Receiving may be responsible for notifying QA of a QA hold or for proper moving of ingredients to storage. Proper handling does not compromise the ingredient through cross-contamination or cross-contact. Another part of the Intentional Adulteration rule addresses the disgruntled employee. Start at Receiving and walk through the potential for an employee to have access to an ingredient or process, with the intent of widespread harm.

Receiving personnel play a key role in the safety of food. By providing the training and resources necessary for them to do their job well, you create a culture of food safety from the beginning.

Paperwork! Paperwork! And more paperwork! Still have questions? The ConnectFood website has free resources, and the folks at ConnectFood are here to help! Contact us.

Kathy Knutson, Ph.D., Lead Instructor for Preventive Controls for Human Food (PCHF), Preventive Controls Qualified Individual (PCQI), and trained in prevention of Intentional Adulteration (IA). She has food safety expertise in microbiology, hazard analysis, and risk assessment. As a recovering academic, she resides in Green Bay home-of-the-Packers, Wisconsin with her brilliant husband and two handsome sons. Learn more about her consulting services at https://www.linkedin.com/in/kathyknutsonphd.

,

If I Am Compliant with a Third-Party Audit, Am I FSMA-Compliant?

One of the biggest challenges for a company and its Preventive Controls Qualified Individual (PCQI) is organizing both the food safety plan and materials for an audit. The food safety plan will be reviewed by the local, state, or FDA inspector. Some companies are under USDA inspection as well. In my experience, most food companies have a third-party audit for BRC, SQF, or ISO 22000 certification or with an auditing firm specializing in food manufacturing. How do you prepare for both?

There are different requirements for a government inspection and a third-party audit. The inspection is driven by public health and regulations. Food facilities will be inspected against the requirements for Good Manufacturing Practices, hazard analysis, preventive controls, and recall plan found in the Preventive Controls for Human Food rule. Quite frankly, the government is not concerned at all with your audit criteria. The focus will be on public health and FSMA rules. Going forward, FDA inspections will evolve in to more audit-like activities with the emphasis on record review. The PCQI is required to organize or oversee the organization of records. The goal is to be inspection-ready at all times.

Much of the material that is required for an audit is the same for an inspection. Each certification or auditing body has their own requirements, and often the PCQI has the responsibility of organizing these materials also. Do you need help with organization? I encourage PCQIs whom I train to find that one person at work who loves office supplies. Put them in charge of labeling and storing materials. Trust me, they will love it! Also, find the person who is exceptionally good at organizing electronic documents. Put them in charge of developing the system of storage and retrieval. The PCQI just needs to know where paper and electronic files are and how to access them.

Do you remember Venn diagrams? List everything you need for an inspection in one circle. List everything you need for an audit in a second circle. What overlaps, and what is unique? One option is duplicating common records for both inspection and for auditing. Another option is to keep records unique to an inspection separate from records unique to an audit and have one record of common records. The inspector will not review records unique to an audit. As you are working through this organization, focus on the best location for individual records, in general. Records for an inspection can be paper or electronic, in a format of your choice. There is no mandate for use of forms. Focus on what makes sense for storage and then retrieval of records.

Let’s go back to the original question. If I am compliant with a third-party audit, am I FSMA-compliant? Maybe; it depends. The Preventive Controls for Human Food rule requires a written hazards analysis which identifies hazards requiring a preventive control. The preventive controls go beyond process preventive controls to include allergen, sanitation, and supply chain preventive controls. If all the preventive controls are addressed in the audit requirements, then you are covered for both an inspection and audit. Beyond the Human Food rule, are you compliant with the Sanitary Transportation rule? In 2019, compliance with the Intentional Adulteration rule takes effect. Are you required to comply with any of the other FSMA rules? The answer is complicated.

Still have questions? The ConnectFood website has free resources, and the folks at ConnectFood are here to help! Contact us.

Kathy Knutson, Ph.D., Lead Instructor for Preventive Controls for Human Food (PCHF), Preventive Controls Qualified Individual (PCQI), and trained in prevention of Intentional Adulteration (IA). She has food safety expertise in microbiology, hazard analysis, and risk assessment. As a recovering academic, she resides in Green Bay home-of-the-Packers, Wisconsin with her brilliant husband and two handsome sons. Learn more about her consulting services at https://www.linkedin.com/in/kathyknutsonphd.

,

Food Allergens: Eight Key Points

I have been teaching for over a year from the Preventive Controls for Human Food curriculum and feel quite comfortable with the topic of food allergens. I heard a talk by Dr. Steve Taylor, Co-Director and Founder of the Food Allergy Research and Resource Program. These are eight key points I learned.

  1. The science of food allergens is new. Food allergens were recognized in 1988. An article in the Journal of the American Medical Association from a physician at the Mayo Clinic reported eight deaths associated with the consumption of food and development of an allergic response. I don’t know the details, but I do know that 1988 was not a long time ago.
  2. Besides the United States, Canada, the EU, FAO and Codex Alimentarius recognize the Big 8 allergens. The Big 8 are dairy, egg, peanut, tree nuts, fish, shellfish, soybeans, and wheat. I wrote that list off the top of my head! Teaching the workshop helps. In the United States, the Big 8 are regulated under the Food Allergen Labeling and Consumer Protection Act of 2004. Other countries may recognize other allergens or include sulfites, which are technically not allergens.
  3. The Canadian Food Inspection Agency pulls food from the shelf and tests for undeclared allergens. Let that sink in.
  4. Very few universities teach the science of food allergens. With food allergens being the number one cause of recalls and food packaging being most responsible, students need to understand quality assurance in a food manufacturing facility and effective methods for cleaning to remove allergens.
  5. Fourteen different companies make test kits for allergens. Buyer beware. There are sensitivity and matrix differences that will get you significantly different results. You are not mandated, but are highly encouraged, to validate your allergen clean process.
  6. Food allergens cause up to 40% of eczema.
  7. Physicians were wrong to tell parents to not introduce peanut butter to infants. The American Academy of Pediatrics guideline for introducing peanut butter is at 4-6 months for infants at highest risk with other food allergies or severe eczema and earlier for infants at lower risk. It is best to blend the peanut butter in another food, to avoid its choking hazard. A peanut butter campaign for pediatricians is needed to reverse the thinking of physicians and well-meaning grandparents. Soon peanut patches will be available, like the technology of nicotine patches.
  8. A safe dose of each allergen does exist. While the US currently has a zero-tolerance policy for allergens, more research is needed to understand low thresholds for each allergen where an allergic response would not occur. In the future, we may move to defect action levels being allowed for each allergen, as the lowest amount allowed in food at a safe level for all.

Still have questions? The ConnectFood website has free resources, and the folks at ConnectFood are here to help! Contact us.

Kathy Knutson, Ph.D., Lead Instructor for Preventive Controls for Human Food (PCHF), Preventive Controls Qualified Individual (PCQI), and trained in prevention of Intentional Adulteration (IA). She has food safety expertise in microbiology, hazard analysis, and risk assessment. As a recovering academic, she resides in Green Bay home-of-the-Packers, Wisconsin with her brilliant husband and two handsome sons. Learn more about her consulting services at https://www.linkedin.com/in/kathyknutsonphd.

,

Supply Chain Preventive Controls

You have a supply chain program. The supply chain program is a prerequisite programfor the safe manufacture of your product. For your ingredients, packaging and other materials, you are sourcing the best materials at the price you are willing to pay. For each ingredient, you have agreed upon specifications with your supplier. Some of those specs are sensory-related, like color, and affect quality. Some of those specs are chemical, like pH or moisture content. Some of those specs are microbiological, like Aerobic Plate Count or absence of Salmonella.

  1. Supply chain preventive controls are required for ingredients where YOUR suppliers control the hazards.
  2. A supply chain preventive control is required for imported packaging when a hazard is identified

The second requirement above is enforced under the Foreign Supplier Verification Program (FSVP) rule. Do you have imported ingredients? These must meet the same food safety standards as domestic ingredients, under the FSVP rule.

Only for those ingredients where you have identified a hazard requiring a preventive control AND the preventive control is a supply chain preventive control, are you REQUIRED to have a supply chain preventive control in your written food safety plan.

Most food manufacturers do not have a supply chain preventive control.

Why would you not have a supply chain preventive control?

  1. You have not identified a hazard in an ingredient or packaging.
  2. You identified a hazard and are controlling the hazard under your own roof.
  3. Your customer will control the hazard.

The good news is there is no validation of a supply chain preventive control! The Preventive Controls for Human Food rule only requires validation of process preventive controls. If you want to read the requirements for supply chain preventive controls in the FDA rule, follow the previous link and find Subpart G at the end of the rule. However, I recommend starting with the FDA At-a-glance document which provides a neat summary of the rule.

Paperwork! Paperwork! Yes, it is all about verification. Include verification of your supply chain preventive control in your food safety plan. Your FDA inspector will ask to see it. Supplier verification is discussed in a separate blog post.

Still not sure if you have a supply chain preventive control? The ConnectFood website has free resources, and the folks at ConnectFood are here to help! Contact us.

Kathy Knutson, Ph.D., Lead Instructor for Preventive Controls for Human Food (PCHF), Preventive Controls Qualified Individual (PCQI), and trained in prevention of Intentional Adulteration (IA). She has food safety expertise in microbiology, hazard analysis, and risk assessment. As a recovering academic, she resides in Green Bay home-of-the-Packers, Wisconsin with her brilliant husband and two handsome sons. Learn more about her consulting services at https://www.linkedin.com/in/kathyknutsonphd.

,

Sanitation Standard Operating Procedures (SSOPs)

In the blog post, The Basics of Sanitation in the Food Industry, I laid the foundation for a successful sanitation program. I discussed:

  • What is soil?
  • The sanitation crew members are your most valuable employees.
  • There are four crucial factors for successful cleaning and sanitizing.
  • What are clean-in-place (CIP) and clean-out-of-place (COP) procedures?

Sanitation crews work hard. Sanitation crews have a lot of turnover and require extensive training and monitoring. The crew must be supplied with the resources they need to do the job right. Crew members must be trained to handle chemicals safely and wear appropriate personal protective equipment. The crew is supplied with EPA-registered cleaning and sanitizing chemicals and follow the manufacturer’s directions. After training and when an employee’s performance is good, please pay them well.

On this foundation, companies will build a sanitation program with training records, Sanitation Standard Operating Procedures (SSOPs), and monitoring of sanitation preventive controls.

Document training.

Every sanitation crew member is a qualified individual as defined by the Food Safety Modernization Act (FSMA) final rule for Preventive Controls for Human Food. FSMA requires documented training records. Most companies fulfill this function through human resources, but owners of small companies may be doing this record-keeping. Because training records are required, you must be ready for a federal or state inspector to review the training records. During the on-boarding process of a new sanitation crew member, document the training. Document a follow-up observation to confirm the work is being done correctly. Document additional training as the employee takes on more responsibilities.

Document cleaning and sanitizing procedures.

SSOPs are detailed step-by-step procedures and can be written with your chemical supply company. The chemical supply company should have resources to answer all your questions. The SSOPs will be tailored to your manufacturing equipment, your product, and your cleaning and sanitizing procedures. Beyond your chemical supply company, there is a wealth of information to sift through on-line. ConnectFood provides resources on their site and will match you up with experts in the design of cleaning and sanitizing programs.

Your company may already be doing all the right steps for cleaning and sanitizing, and that is great! Attaining clean and sanitary equipment as well as manufacturing environments supersedes all other sanitation team goals. However, written SSOPs will help to ensure that all sanitation crew members are following the same steps in the way the procedures were designed. Written SSOPs are critical to training. Remember, there is usually great turnover in sanitation crews, and new employees are frequently being on-boarded. If crew members are unsure about a step or disagree about a step, the written SSOP will explain the procedure to follow. If there are deviations, the written SSOP will get the process back on track.

I highly encourage clients to write SSOPs with pictures of the chemical labels, tools being used on equipment, clean-in-place control panels and tanks, and the finished job of clean surfaces. A picture is worth ten thousand words, said Fred R. Barnard. Click here to see a splendid example of an SSOP with pictures that I found on-line.

Effective SSOPs are key in our complex world of allergen control. Does your product contain one or more allergens? The big eight regulated by the FDA are wheat, soy, egg, milk, peanut, tree nuts, fish and shellfish. If you make a product which contains an allergen and then use the same line to make another product without the allergen, you must have a complete allergen clean step. The clean step is designed to remove residue of the allergen, so that cross-contact into the next product does not occur. In this case you would have a preventive control for the allergen.

Monitor cleaning and sanitizing.

If you have an allergen clean step or an environmental monitoring program as required by the FSMA Preventive Controls for Human Food rule, you will have a preventive control in your cleaning and sanitizing program. With a preventive control comes the requirement to monitor and document the step. Record-keeping proves you did what you say you are doing in your SSOPs. Keep this simple! Here are examples of what you can record:

  • Visual check after cleaning with a simple pass/fail
  • ATP test result
  • Amount of cleaner added to what amount of water
  • pH of cleaning solution
  • Concentration of sanitizer with a dip test strip
  • CIP tank temperature
  • CIP run time on a recording chart
  • Sanitation supervisor checks that an allergen clean was done after production with an allergen

Use this list as a menu of choices and add your own options. If this information creates more questions, seek out resources. The science of cleaning and sanitizing is vast, in which some people have devoted their entire careers. The concept is that you must prove that you did what you say you are doing in your SSOPs. If critical parameters for successful cleaning and sanitizing are time, temperature, and concentration, then how are you going to document the data?

The search for forms and checklists can be overwhelming, and the ConnectFood website has free resources. The partners at ConnectFood are here to help! Contact us.

Dr. Kathy Knutson has food safety expertise in microbiology, hazard analysis, and risk assessment. As a recovering academic, she resides in Green Bay home-of-the-Packers, Wisconsin with her brilliant husband and two handsome sons. Learn more about her consulting services at https://www.linkedin.com/in/kathyknutsonphd.