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FDA published the draft guidance Determining the Number of Employees for Purposes of the “Small Business” Definition of Parts 117 and 507: Guidance for Industry on March 19, 2018. The comment period is through May 20, 2018. The purpose of the guidance is to raise awareness of exemptions for Part 117, the human food rule, and Part 507, the animal food rule. There is also a later compliance date for small businesses under the animal food rule of September 17, 2018, than originally set. I am addressing human food within this blog.

Why did FDA publish this draft guidance?
I’m having a difficult time understanding the publication of this Food Safety Modernization Act (FSMA) draft guidance at this time. It is helpful in defining subsidiary, affiliate, facility and full-time equivalent (FTE) employee. There are clear examples to showcase types of facilities and calculations of FTEs. The purpose of calculating FTEs is to determine if a facility is defined as a small business of less than 500 FTE employees. This is a concern when multiple facilities are related and if there are part-time or seasonal employees. This is a question I have tried my best to address in PCQI workshops for my participants. It’s nice to have the draft guidance. The reason I am having a difficult time is that it is a moot point for industry now. All small businesses came under enforcement in September 2017 for human food. Small businesses must meet the same requirements their larger competitors met in September 2016.

    I believe the reason for the publication of the draft guidance
    is not as much for industry as it is for the FDA.

Will my facility be inspected?*
FDA prioritizes their inspections, so FDA must know if a facility is a small business or larger. In fiscal year 2016-2017 when businesses with more than 500 employees came under enforcement, FDA’s goal was to complete 300 FSMA inspections. Facilities with more than 500 employees were under inspection first, because of the potential public health impact to a larger number of consumers. A total of 165 domestic and foreign FSMA inspections were completed. All other inspections-the majority-were Good Manufacturing Practices (GMP) inspections. That trend will continue with most inspections being GMP inspections. The FDA continues to train its inspectors on FSMA, and FDA inspectors are primarily in a FSMA educator mode with industry. In fiscal year 2017-2018 the goal is higher at 500 FSMA inspections; the pace is faster.

In addition to the number of FTEs, there are other factors used by FDA to prioritize inspections.

    • Domestic and foreign facilities goals are 400 and 100 inspections, respectively.
    • Facilities with a current or previous Class I recall or warning letter
    • Facilities in the same market as a facility with a Class I recall
    • Facilities making a high-risk ingredient or product

      1. Ready-to-eat foods
      2. Foods identified in FDA’s Listeria risk assessment
      3. Foods otherwise with a history of risk

While it is not possible to know if your facility will be inspected until the FDA inspectors are at your door, you can determine the likelihood by using the same tools FDA has to prioritize inspections.

*The author participated in a Food Safety Preventive Controls Alliance quarterly webinar for Lead Instructors on February 8, 2018, in which FDA inspection data was shared.

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

About the Author
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

I am writing this on September 18th, 2017. For over a year I have trained people in workshops that this date is the FDA enforcement date for all food companies as regulated under the Food Safety Modernization Act (FSMA)’s Preventive Controls for Human Food rule. The small companies had more time for compliance, but this is it. Time is up.

Going forward from this day, all food companies in the United States earning more than $1 million in annual revenue must have a written food safety plan. The written food safety plan starts with a written hazard analysis and ends with a written recall plan. The food safety plan must meet the requirements in Subpart C of the Preventive Controls for Human Food rule. Today changes the way I teach, the way FDA enforces, and the way food companies prove food safety.

Even though today is the day, word on the street is that the FDA is a little behind on FSMA inspections. The FDA has done a great job training inspectors, providing guidance, and giving inspectors the tools they need. I hear that FSMA inspections will be more like audits: with the emphasis on review of the food safety plan and employee training records. There will be less time walking the line and more time reviewing monitoring and verification records. That being said, most FDA inspections are still for Good Manufacturing Practices, found in Subpart B of the Preventive Controls for Human Food rule. If your company manufactures a product that has been recalled by a competitor or is known to be under high scrutiny by the FDA, then you should be prepared for an inspection in the near future. If not, you may have more time to prepare.

Are you feeling overwhelmed? Did you find this blog post because your food safety plan is not finished or you feel it is lacking? I do not want you to feel alone or isolated from the resources and help you need. There are plenty of food companies still writing their food safety plans, so you are in good company if yours is not yet complete. You have landed in the right place – let ConnectFood help you get it done!

ConnectFood is a great tool to write your food safety plan. You can choose the free option, which is a good place to start, or you can subscribe for a low, reasonable cost. By subscribing, you will have access to the ConnectFood experts, like ConnectFood CEO Matthew Botos, myself, and other ConnectFood experts. If we don’t have the answer, we have a vast network of food safety experts to get you the answers you need.

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.

On August 8th and 9th, 2017, the ConnectFood team hosted the 2017 Illinois Food Safety Symposium in Bloomington-Normal, Illinois. There were nearly 250 food industry professionals that attended the two day event. ConnectFood organized and led the Symposium in order to continue the tradition, previously established by the Illinois Department of Public Health of bringing together regulators, academia, and industry professionals in order to work towards continuous improvement of the food safety environment in Illinois.

If you were unable to join us at the Symposium, we hope you enjoy this short overview of what you missed, and that you’ll be interested in attending next year!

The Symposium was started the Keynote address from Mike O’Grady, Vice President of the Bloomington-Normal Economic Development Council, and Molly Lamb, Deputy Director at Illinois Department of Public Health. Both touched on the fact that the food safety industry in Illinois is incredibly strong, but that there are many areas that are being expanded and strengthened. Matthew Botos, CEO of ConnectFood, introduced two of our exhibitors: Cheryl Hodges from Miller & Stryker, and Renee Hoggay from the National Restaurant Association, and encouraged them to speak about their products and businesses.

Matthew Botos, CEO, ConnectFood, welcoming the crowd to the 2017 Illinois Food Safety Symposium.

As participants refilled their coffee mugs and grabbed morning snacks, Dr. Robert Brackett, Director of Institute for Food Safety and Health set up for his discussion of Food Safety Modernization Act (FSMA) & Compliance. He began by introducing the foundation of FSMA – why is it necessary? In the shortest summary possible: FSMA is necessary because food supply is more complex, and an increased percentage of the population is at risk for foodborne illnesses. Dr. Brackett also covered the seven rules of FSMA: Preventive Controls for Human Foods and Animal Foods, Produce Safety, Foreign Supplier Verification Program, Accredited Third Party Certification, Sanitary Transport, and Intentional Adulteration. The first FSMA Compliance dates are right around the corner (this month, in fact): September 17-19th, 2017, so if you need help making sure you’re compliant, now is the time to act.

Dr. Bob Brackett at the 2017 Illinois Food Safety Symposium.

After lunch, Dave Park, Principal, Food Defense, LLC spoke on the topic of Food Defense. He touched base on the history of food defense, food fraud, the intentional adulteration rule, and the comparison of new regulations to HACCP. Mr. Park highlighted food defense audit failures, threats and risks, imports and refusals, and food fraud incidents. “The general Hazard Analysis and Vulnerability Assessment procedure is the same, but the perspectives and expert knowledge bases used are different.” We are told to “Remember: Food Safety + Food Defense = Food Protection.”

Dave Park speaking at the 2017 Illinois Food Safety Symposium.

Next, Matthew Botos moderated a panel regarding Distribution and Transportation of Products, featuring the expertise of Tanesia Cole, Manager of Food Regulatory Compliance at US Foods, and Jeff Newey, Manager of Deseret Transportation. Both members of the panel highlighted their individual company’s background; explaining what they ship, how their shipment process works, and the procedures that are in place to ensure safety in the distribution step. Both touched on the transportation rule of FSMA, urging folks to shift their way of thinking to match the safety regulations of the new rule.

Tanesia Cole & Jeff Newey at the 2017 Illinois Food Safety Symposium.

To close out day one, Matthew Botos, CEO of ConnectFood, and Chris Metz, CTO of ConnectFood, hosted a demonstration of the ConnectFood.com software. I won’t dive too much into detail here, but if you’re interested in a software demonstration, please contact us & we would be pleased to show you around our website. We wrapped up the day with a short reception, and set our focus on day two.

Matt Botos, CEO, and Chris Metz, CTO, ConnectFood, at the 2017 Illinois Food Safety Symposium.

Day two opened with William Weissinger, District Director at FDA Chicago District, speaking about FDA Inspections & Enforcement Then and Now: Changes Over 5 Years. Ultimately, Weissinger said that the current goal of FDA inspections is to educate while regulating, meaning that the industry shouldn’t attempt to know exactly what to expect during an inspection, as inspections are by special assignment. In addition, it was stressed that all food manufacturers (regardless of size) must be registered with the FDA. (If you need help with that, contact us.)

William Weissinger speaking at the 2017 Illinois Food Safety Symposium.

Jessica McAnelly, Chief, Division of Food, Drugs, and Dairies at Illinois Department of Public Health (IDPH), took over the podium next. She spoke on the state of public health in Illinois, which ended up being a major talking point for a lot of attendees. She spoke about new legislation and updates to the existing legislation. Allergen awareness training is included in these updates – a main change included was that the certified food protection manager must get allergen training within 30 days of employment at a high-risk restaurant. Another major announcement of this presentation was that IDPH will no longer validate hours for Food Service Sanitation Manager Certification (FSSMC) – the Certified Food Protection Manager is a required, national certification.

Jessica McAnelly speaking at the 2017 Illinois Food Safety Symposium.

After lunch, it was Eric Greenberg, Principal Attorney, Eric F. Greenberg, P.C.’s turn to chat with participants about Labeling & Nutrition. The finalized changes for the FDA for Nutrition Facts Label are as follows: calories presented more prominently, an altered format, and added sugars included. Unfortunately, these changes have been postponed indefinitely. In Mr. Greenberg’s words: “One thing’s for sure in the future: Label compliance will always be primarily the responsibility of food companies, and this is especially so given the FDA’s enforcement patterns.”

Eric Greenberg at the 2017 Illinois Food Safety Symposium,

ConnectFood team member Dr. Kathy Knutson moderated our second day panel. (You’ve probably read her outstanding blogs for ConnectFood – if not, check them out here.) This panel included members Joseph Cooper, Emergency Response Coordinator, Chicago District Office, Mancia Walker, Supervisor, Indianapolis Resident Post OHAFO 6E, and Christinae Hudson, Consumer Complaint Coordinator, Chicago District Office. They discussed Recalls & Outbreaks – what they’d seen, effective ways to handle them, and how important recall plans are for the safety of a company. A crowd pleaser that was discussed was the Blue Bell ice cream recall that was enforced across the state of Texas after the delicious ice cream was contaminated with Listeria.

Dr. Kathy Knutson and Matt Botos moderate the Recalls and Outbreaks panel.

The final speaker at the Symposium was Laurie Jahn, Senior Environmental Health Program Specialist of Lake County Health Department, talking about juice production & safety. The objectives of this presentation were to understand the methods of fresh juice processing, determine the code regulations, and present labeling requirements for bottling fresh juice. The main concerns with fresh juice are the possibilities of cross contamination and that there is no kill step, which leaves the juice untreated.

Laurie Jahn speaking at the 2017 Illinois Food Safety Symposium.

Matthew Botos wrapped up the Symposium with a final “thank you!” to everyone that joined us. If you attended the Symposium and have some feedback or need to obtain your certificate of completion, please complete this survey. As always, the ConnectFood team is always available to help you understand food safety. All you need to do is contact us.

Johanna Seidel has been a team member with ConnectFood since July 2016. She holds a B.F.A. from West Texas A&M University. She helped organize and run the 2017 Illinois Food Safety Symposium. https://www.linkedin.com/in/johanna-seidel-3a98b6130/

Johanna Seidel, ConnectFood, celebrating the completion of the 2017 Illinois Food Safety Symposium.

At the Food Safety Summit 2017 I heard an announcement that piqued my interest. The FDA and my home state of Wisconsin have an agreement for recognizing the other’s inspections. There will not be duplicate inspections! That is great news. Wisconsin Department of Agriculture, Trade and Consumer Protection (WDATCP) and the FDA Minneapolis District Office (MN‐ DO) have developed a process for sharing inspection reports, work plans and establishment inventories; read more about that agreement here.

First, I want to state the obvious. That’s the way it should be. I feel for the food companies that have more audits and inspections than there are months in the year. Inspections are time-consuming and costly to business. Food prices include the cost of audits and inspections.

This was a big announcement at one of the keynote presentations in front of a packed room. It was big, because that is not what is normally done. Even though the state and FDA inspectors use the same federal rules and have the same goals, they rarely coordinate inspections, resulting in duplicity.

The other reason this agreement makes sense is that both FDA inspectors and state inspectors are going through the same training on the FSMA rules. Matt Botos, ConnectFood CEO, and I know, because we trained them. For the last year I have had state of Wisconsin inspectors in my Wisconsin workshops and FDA inspectors in workshops across the nation. Everyone feels better knowing that FDA inspectors, state inspectors and industry are all in the room for training together. I have only had good experiences with exchange of information. I did not get a sense in the classroom that industry was shy about asking questions, which one might fear. Inspectors were honest about where they were in the process of learning and enforcing the Preventive Controls for Human Food (PCHF) rule. As I have attended training, listened and read about the roll out of other FSMA rules, I have heard over and over that FDA plans to train inspectors with industry, following the training model of the PCHF training. That is more good news.

At Food Safety Summit 2017 I confirmed that FDA is conducting 300 PCHF inspections for fiscal year 2016-2017, the year ending in September. These will be at businesses with more than 500 employees. Other inspections beyond the 300 will be GMP inspections and are designed to educate on PCHF. The food industry can relax (a bit) in the knowledge that the FDA is getting trained alongside industry and will use inspections as an opportunity to educate on FSMA.

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.