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Traffic. I lived for 15 years in a Chicago suburb, where traffic to anywhere was a normal part of life. I didn’t hate the line of cars at a stop light or the stop-and-go on the interstate at rush hour. The opening scene of the musical LaLaLand starts with a visually beautiful number on the stalled LA freeway, a normal part of life there. The last episode of Homeland that I watched showed Saul waiting to enter the West Bank in a sea of cars. Traffic is a part of life. We are directed when and where to go.

In a visit to a food factory, I stood at the nexus and observed the traffic where every employee and every forklift traveled. I could see the employee entrance and the stairs to the employee break room. The forklift moved product from packaging to the dock. The stairs to the lab. The path to the maintenance room. The hall to the front offices. It was all there-so much traffic. A production worker walked through processing, through packaging to the raw side and back. The forklift went everywhere, including outside.

It was an old building that had been added to over and over again. Yet, in that one spot I could see so much. What I could not see was the transfer of pathogen contamination, and I was there to do thousands of dollars in testing to find the contamination. There was no concern of allergen cross-contact, but there was the concern of pathogen cross-contamination. The pathogen had gotten in somewhere, and the test results would show it was all over.

Foot traffic. Yes, there were footbaths. Could the production worker call a different worker on the raw side and eliminate that trip? When the employees enter from outside, there must be an area to shed the outer world and don clean coverings after hand-washing. That is not negotiable. Any time an employee uses the restroom, goes on break, goes to the lab, or goes to the office, they must not carry a pathogen out or in. Are there maintained footbaths, foot sprays, or air curtains to keep pathogens out of areas where product is exposed? Where is the transition area for each path? Are the employees trained to understand not only the how and when, but the why? Does your smoking policy send workers outside to their vehicles multiple times a day to track dirt back in the building?

What to do? Work needed to be done, and product needed to be moved. It’s all about transition areas. Could one forklift move the product on pallets to the dock area and another forklift pick up the pallet from the other side and load? Yes, forklifts dedicated to a task or an area do exist. You say you can’t afford dedicated forklifts for different areas? Can you afford a recall? I just read the average recall has a direct cost of $10 million. That’s a lot of forklifts.

The FDA will be judging your company for evidence of a food safety culture. How you manage your employee and forklift traffic becomes that evidence. A stop-and-go light is a sign directing the flow of traffic. Signs make our lives safer, and signs are evidence of a food safety culture. Set up transition areas and dedicated hand wash stations with clear access and signage. Create a food safety culture where every employee holds every other employee accountable to transition area procedures.

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.

I listened to a webinar by Adam Borger of the University of Wisconsin-Madison’s Food Research Institute on calculating thermal lethality of microorganisms in foods. In one hour, he did an excellent job of reviewing what I learned in Food Engineering class at the UW (OK, I learned more than that) and applied the information to show how industry can do the math. Have you ever had a process fail, but want to know if the heat was enough to kill? There are spreadsheets publicly available to do the math.

At the end of the talk, Adam referred to validation studies. Is your company one where validation of the kill step has yet to be done? Maybe you do baking, roasting or frying. Under FSMA, companies must have validation of process preventive controls. Our own Matthew Botos here at ConnectFood is a process authority for acidified foods. A process authority is someone who will work with you to validate your process with your product. Legally, manufacturers of acidified and low-acid canned food must use a process authority to validate the thermal process. Process authorities can be found among extension professors, contract labs, and consultants. While writing this blog, I did a search and found listings of process authorities by AFDO by state:

and the Department of Health and Human Services lists four universities in this document:

Only if you are hermetically sealing your product are you required to work with a process authority, internally or externally. Otherwise, validation of your process can be done in many ways. If you can find processing time and temperatures in the scientific literature for your product, you may cite that source. For example, milk pasteurization times and temperatures are published by FDA in the Pasteurized Milk Ordinance. Similar published data may be available for your product. One way to do this search in on Google Scholar; ask a young person about that. After doing a search, you may still need to measure the temperature profile of your product through your process. BEWARE, Peanut Corporation of America, responsible for nine deaths from Salmonella-contaminated peanut butter, had a perfectly good roasting operation that WAS NOT VALIDATED. This is a great example for the need for validation of your process preventive controls.

Get that validation study in your food safety plan. Your FDA inspector will ask to see it.

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.

Regulators, what are they good for?

When I think about regulators, I think about the wonderful people I met this year while teaching the Preventive Controls for Human Food workshop. I had participants who were state inspectors, and I had FDA inspectors. Some were very knowledgeable and could have taught the workshop. Some were new to their jobs and were learning from the beginning just like many of the industry participants. We all have the same goal of safe food.

When I think about regulators, I think of the ones I have not met, but I know their stories. I know about the state inspector who bullied a company on a Friday afternoon to initiate a recall based on presumptive lab results. I know about the inspector who labeled a control panel swab as a zone 1 sample, and when it came back positive the company had to recall the product. I know about the inspector who chatted up the quality manager about personal matters and wasted a day’s work. There are stories after stories about the demanding, unknowledgeable inspectors who are unreasonable. Just like the news of the world, these are the stories we hear, and we start to believe they represent the whole. They do not.

I am encouraged to know that the inspectors are being trained using the same curriculum as that used to train industry. I am encouraged that FDA inspectors are in the same room with industry participants for the discussion and debate on the material. We are all in this together.

FDA rules and guidance documents are available for free on-line. The much-anticipated Hazards and Controls guidance was published in draft form at the end of August. See the link below. The document is in a six-month comment period. Individuals and organizations can submit comments. After the comment period, the FDA must address every comment, and publish the final guidance document. After working with the FDA, I expect this document to be published around the end of 2017. The Hazards and Controls guidance is critical to inspections. Some inspectors will use it as the bible for inspections. If the guidance identifies a hazard in the food you produce, you better have a preventive control for that hazard or have written justification as to why you do not have a preventive control for that hazard.

So, what do you do in the meantime? You can check the FDA Hazards and Controls draft guidance, or you can go to Canada! The Canadian Food Inspection Agency (CFIA; remember chapter 7 in the PCHF workshop?) has a searchable database; see the link below. This is a technical resource you can cite in your hazard analysis. Check it out!

I know there are many other resources for inspectors, including more training programs. The International Food Protection Training Institute (IFPTI) coordinates training of inspectors with the Association of Food and Drug Officials (AFDO). The IFPTI website provides a link to online courses available free for FDA, State, Local, Territorial & Tribal (SLTT) regulators at:
http://www.fda.gov/Training/ForStateLocalTribalRegulators/default.htm
This summer I asked about these courses being available to industry and the reply was yes, for a fee. Contact the Director of IFPTI, if you are interested in this training for your company.

FDA Hazards and Controls draft guidance
http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/ucm517412.htm
See Download the Draft Guidance.

CFIA searchable database
http://active.inspection.gc.ca/rdhi-bdrid/english/rdhi-bdrid/searece.aspx?i=11

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.

I am a Preventive Controls Qualified Individual (PCQI). What have I gotten myself into?

First, congratulations! You have taken a big step in preventing hazards and providing a safe food for your customers. When teaching the PCQI course, we emphasize four major responsibilities of the PCQI:

  1. Create and implement the food safety plan
  2. Validate preventive controls in processing and potentially for allergens and sanitation
  3. Review records
  4. Reanalyze the food safety plan

As you can see these are large areas filled with details. Much of the work of a PCQI is focused on getting the food safety plan written, including the recall plan. You are going to do this in a team. It works better in a team. You can delegate. Reach out to personnel who you do not routinely work with, like human resources, sales, purchasing and transportation. I encourage my workshop participants to let go and let others do the work. As PCQI, you have to oversee the writing, but you do not have to do the writing. Find that super-organized person in your company, and have them do the organizing of materials and reminding others of deadlines set by the team. We all have that person who loves to tell others what to do. Put the full authority of the PCQI behind that person and unleash him or her.

Your day-to-day and week-to-week operations may not change much from what you do now. You will find steps where there is control of a hazard and document that. Much of this is done and already being done. In your hazards analysis, you identify process, sanitation, allergen and/or supply chain preventive controls, their corrective actions or corrections, and record keeping. You may identify hazards that were not previously identified and documented, but that work will just become part of your food safety system and part of your daily and weekly work along with what you have been doing.

Each PCQI works in a different food factory with different ingredients, equipment and products. Some factories have been operating the same way for decades and foresee no changes. Some factories are brand new. Some factories are expanding and bringing in new lines and their equipment. The food safety plan must be reanalyzed every three years, if there is no reason to do so earlier. Earlier reanalysis is at least discussed at the identification of a new hazard, new supplier, new equipment, new product… You get the picture. Any time there is a change in the food safety system, you as PCQI will document that you addressed the hazard potential and either changed the food safety plan or decided the current food safety plan controlled the hazard. The key to your success is documentation, but you already knew that!

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.

Recently, I sat in a room with 20-some food safety experts eager to learn about the curriculum for the Preventive Controls for Human Food rule. The FDA-recognized curriculum is used as the primary means to call oneself a Preventive Controls Qualified Individual. At the start and at hearing the use of “preventive,” my colleagues and I whipped out our cell phones to look up the existence and meaning of the word. Well, I will tell you it is a word, is chosen for use by FDA, and means the same as “preventative.” Out loud, say to yourself, “preventive measures.” Sounds good, doesn’t it?

Preventive is not the only new word to the rule. The terms of HARPC, still in its infant stage, and its older siblings of HACCP, CCPs, and critical limits are fading into the sunset. If you are a food safety expert who has grown up on the use of HACCP and CCPs, don’t worry. FDA is not making you use the new language. There is still room for use of HACCP and CCPs when identifying process preventive controls. After all, processing is where much of the highest risk in food safety is controlled. Water is removed to prevent growth of mold and production of harmful toxins. Heat is used in pasteurization, canning and baking to kill pathogens. We use metal detectors. The youth in our business will label these process preventive controls, not CCPs. The youth will be studying the rule and the language of the rule.

There are three additional labels of preventive controls-allergen, sanitation, and supply chain. We do not apply the terms of HACCP, CCPs or critical limits to preventive controls in these three areas. Your hazard analysis will identify if you need a preventive control in any of these areas. We identify preventive controls for known or reasonably foreseeable hazards, and set parameters and values. Parameters are just the name of the measurement like temperature, time, belt speed or bed depth. Values are the number and corresponding unit which must be achieved for safety like 185oF, 25 minutes, 1 foot per second, or 2 cm.

Another new kid on the block is the term “correction.” We will still issue corrective action when a food safety issue affects finished product. What about when product has not been affected? The wrong label is moved from storage to the packaging line. Get the right label. A post-sanitation inspection observes areas not cleaned properly. Reclean. A correction allows the righting of a wrong at a preventive control step and before any product is affected.

It takes practice to adopt the new language of the rule. As an educator, I encourage you to say the terms out loud. After some time and in our future, we will hear a colleague say, “What’s HACCP?”

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.

Do I really need a food safety plan?

Start here. Facilities registered with the FDA as manufacturing food must comply with the Food Safety Modernization Act final rule, Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food. In the Preventive Control Qualified Individual curriculum, Preventive Controls for Human Food, a point is made that if a hazard is identified in the hazard analysis requiring a preventive control, then a written food safety plan is required. I am aware of only one company that has only one hazard identified, and the risk is truly low. Most companies can easily identify a hazard which must be controlled.

There are two more questions to answer. Am I exempt from the requirement to have a written food safety plan? If my facility is not exempt, when is my compliance date? The latter question is the easiest to answer. There are three compliance dates.

Businesses employing over 500 full-time equivalent employees must be compliant September 19th, 2016. I call these businesses “large;” FDA calls them “other.” September 19th has come and gone and the world has not ended. I am waiting to hear about FDA inspections under the human foods or animal foods rule. Please share.

Where did the medium facility go? Nowhere. There is no legal definition for a medium facility.

Small businesses employ fewer than 500 full-time equivalent employees and have over $1,000,000 in annual sales and holdings. Their compliance date is September 2017.

Very small businesses have less than $1,000,000 in annual sales and holdings. Their compliance date is September 2018. The latter date is also given to Grade “A” milk processors following the Pasteurized Milk Ordinance.

So, which one are you? Large, small, or very small? Now for the answer to the other question. Am I exempt from the requirement to have a written food safety plan? There are many operations which are exempt from having a full food safety plan. It is not possible to describe all exemptions here, but let’s look at a few examples:

Farms. Farms produce raw agricultural commodities (RAC). You would think this is a no-brainer, but the FDA has written a lot into the definition of a farm. Here is a little taste of what is written by the FDA.

Table 4—Revisions to the Proposed Definitions in the Section 415 Registration Regulations and the Section 414 Recordkeeping Regulations
Definition Revision
Farm A farm is an “operation” rather than an “establishment.” There are two types of farms: (1) Primary production farm; and (2) secondary activities Farm.
Primary production farm
  • A primary production farm is “under one management” rather than “under one ownership.” Although a primary production farm continues to be “in one general physical location,” we have clarified that “one general physical location” is “not necessarily contiguous.”
  • A primary production farm is an operation devoted to the growing of crops, the harvesting of crops, the raising of animals (including seafood), or any combination of these activities. Although some primary production farms both grow and harvest crops, other primary production farms grow crops but do not harvest them, and other primary production farms harvest crops but do not grow them.
  • Treatment to manipulate the ripening of RACs, and packaging and labeling the treated RACs, without additional manufacturing/processing, is within the “farm” definition.
  • We added an example of drying/dehydrating RACs to create a distinct commodity that would fall within the “farm” definition (i.e., drying/dehydrating grapes to produce raisins), as well as an example of additional manufacturing/processing that would cause an operation that dries/dehydrates RACs to create a distinct commodity to fall outside the “farm” definition (i.e., slicing).
  • We added an example of additional manufacturing/processing that can cause an operation that packages and labels RACs to fall outside the “farm” definition (i.e., irradiation).
Secondary activities farm A “secondary activities farm” is an operation, not located on a primary production farm, devoted to harvesting (such as hulling or shelling), packing, and/or holding of RACs, provided that the primary production farm(s) that grows, harvests, and/or raises the majority of the RACs harvested, packed, and/or held by the secondary activities farm owns, or jointly owns, a majority interest in the secondary activities farm.• A secondary activities farm may also conduct those additional activities allowed on a primary production farm.

Compliance for produce follows a separate rule, Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption.

Qualified facilities. Qualified facilities are not required to have a written hazard analysis, preventive controls, or supply chain program. In creating exemptions, the FDA has tried to identify foods with low risk to consumers. This includes foods traditionally seen as safe due to processing, with limited distribution, lack of allergen and made at a farm mixed-type facility. Consider these foods made on “farms” by very small businesses.

  • Baked goods such as bread and cookies-The bake sale survives.
  • Game meat jerky-Note: USDA is responsible for non-game meats.
  • Pasteurized honey
  • Maple syrup
  • Jams, jellies and preserves-Think of all those pickled foods at your local farmers’ market!

Qualified facilities must follow Good Manufacturing Practices (GMPs) as detailed in Subpart B of the final rule. Businesses compliant with the juice HACCP rule or seafood HACCP rule must follow GMPs from Subpart B of the human foods rule. Infant formula has its own rule. Dietary supplements are covered under 21 CFD 111, but ingredients manufactured as dietary ingredients require a food safety plan. Alcoholic beverages are still exempt, because FDA has no jurisdiction over them. Low-acid canned foods must be compliant with their own rule which prevents microbiological hazards and have a food safety plan for chemical and physical hazards.

Warehouses. If the warehouse does no other activity, the warehouse is exempt from a food safety plan and still follows GMPs. In other words, the packaged food is delivered to the warehouse, sits in storage, and is moved out of storage. There can be no relabeling or repacking of the food.

Still confused? You are not alone. If you feel that your facility may be exempt, check into it. Contact us at ConnectFood or your local FDA office. Remember, the goal is a safe food supply, but there are reasonable exemptions to the rule.

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.

In June 2016 I started teaching a workshop with FDA-recognized curriculum. Everyone was there to get a certificate as a Preventive Controls Qualified Individual (PCQI). After a day of training, someone asked, “What is FSMA?” Much to my own surprise I could not succinctly articulate the extent of FSMA nor did the curriculum do a great job of summarizing FSMA. After much research on the FDA and Federal Register websites, I have this summary for you.

FSMA is the federal Food Safety Modernization Act, signed by President Obama in January of 2011. The purpose is to ensure the U.S. food supply is safe by shifting the focus from responding to hazards to preventing them (https://www.fda.gov/Food/GuidanceRegulation/FSMA/). I now understand there are seven foundation rules with FSMA, all under the jurisdiction of the FDA. All seven rules were published from September 2015 to May 2016 with unique compliance dates. Most of you reading this are going to want information on the rule for the manufacture of human food. The preventive controls for human food final rule requires a written food safety plan, record-keeping, a recall plan, and oversight by a PCQI. A future blog will detail the role of a PCQI.

Final rule: Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food
Who? Human food manufacturers and their ingredient suppliers

When? Initial compliance date of September 2016 for large businesses

FDA actually calls large businesses “other businesses.” That is because the large businesses by definition are not small, very small, qualified facilities, or subject to the Pasteurized Milk Ordinance. All of these have compliance dates beyond September 2016.

Small businesses have a compliance date of September 2017 and are defined as having fewer than 500 employees. Therefore, “other businesses” have more than 500 employees. Very small businesses have a compliance date of September 2018 and are defined as having less than $1,000,000 in annual sales and holdings. By default, very small businesses have fewer than 500 employees. With only $1,000,000 in revenue, that makes sense that the business employs fewer than 500.

Very small businesses are qualified facilities. Having a designation as a qualified facility exempts the facility from the hazard analysis, preventive controls and supply chain requirements. This is a big deal. The business is still required to follow Good Manufacturing Practices, provide attestations in support of their status, provide evidence of oversight and compliance in their location, maintain records, and provide evidence of status annually. Even though a qualified facility is not required to conduct a hazard analysis and identify preventive controls for those hazards, the qualified facility is required to state how they are controlling hazards in their process. In other words, what is the qualified facility doing to make their product safe for the consumer? If a very small business believes they are a qualified facility, their status records must already now be in place.

Businesses subject to the Pasteurized Milk Ordinance (PMO) have a compliance date of September 2018. These grade A milk processors come into compliance after the next revision of the PMO is published. The PMO will include elements of preventive control requirements.

What are the foundation rules of FSMA? Here is a summary of them:

Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals
This is the animal food rule.
Who? Animal food manufacturers and their ingredient suppliers
When? Initial compliance date of September 2016
In the same way that food for human consumption must be made in a safe manner, the diverting of human food to animal food and the production of animal food must be done safely.

Foreign Supplier Verification Programs for Importers of Food for Humans and Animals
This is the import rule.
Who? Importers of ingredients or food for humans or animals
When? Initial compliance date of May 30, 2017
To see descriptions of who has later dates, go to this FDA document at https://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm517545.htm.

Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption
This is the produce rule.
Who? Raw agricultural commodity farmers
When? Produce growers with more than $500,000 in annual sales must be compliant starting in November 2017. Small businesses with annual sales between $250,000 and $500,000 must be compliant November 2018. Very small businesses with annual sales between $25,000 and $250,000 must be compliant November 2019. Due to high risk, sprout growers must be compliant in November 2016, with small and very small sprout growers compliant in November 2017 and 2018, respectively.
Growers may have modified compliance dates for parts of the rule including water quality standards, testing and recordkeeping; labeling; or retention of records supporting eligibility for a qualified exemption. Many commodities are exempt from parts of the rule due to the nature of the crop.

Accreditation of Third-Party Certification Bodies To Conduct Food Safety Audits and To Issue Certifications
This is the audit rule.
Who? Third-party auditors
When? The rule was published November 2015. The Model Accreditation Standards when published will include FDA’s final recommendations on third-party auditor/certification body qualifications and incorporate requirements. Thereafter, auditors will be able to apply for FDA recognition. See the draft guidance for the Model Accreditation Standards at https://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/ucm455328.htm.

Sanitary Transportation of Human and Animal Food
This is the transportation rule.
Who? Motor carriers, shippers, and receivers of human or animal food
When? Initial compliance date of April 2017
Motor carriers employing fewer than 500 persons and having less than $27.5 million in annual receipts must be compliant in April 2018.

Mitigation Strategies to Protect Food Against Intentional Adulteration
This is the intentional adulteration rule.
Who? Human food manufacturers
When? This being the last of the rules was published in May 2016. The first compliance date is May 2019. Small businesses employing fewer than 500 employees must be compliant in May 2020.
The definition of the very small business is annual sales and holdings less than $10,000,000 and not $1,000,000 as defined in the preventive controls for human foods rule. The very small business must be compliant in May 2021.