Tag Archive for: recalls

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Truisms About Food & Documentation

Eric F. Greenberg, a private attorney with a practice concentrated in representing FDA-regulated food companies and others.
Informational only, not legal advice

There are several truisms about food companies and documentation:

MORE DOCUMENTS THAN EVER
First, companies producing FDA-regulated foods these days are required to make and keep more documentation than ever, mostly due to the Food Safety Modernization Act of 2011. Companies are required to generate, for example, food safety plans with a hazard analysis and preventive controls, a supply chain program and a recall plan. Then, after setting up these systems, companies need to generate and keep documentation proving they are following the programs they established.
Also, companies who recall food should remember that they might have reporting obligations, within 24 hours of discovery, about food that might be a danger to health, via the Reportable Food Registry portal.

DOCUMENTS ARE NOT ENOUGH: ALSO TRAIN
Second, once you have set up those documented programs, don’t neglect to train your employees on what they require. This goes for recall plans as surely as any other aspect of your program. FDA inspectors think perty documents are fine, but they would rather see confirmation that your people have a thorough knowledge of what’s in them and operate under them all the time. Which leads to the third point…

DOCUMENTS ARE NOT ENOUGH: ALSO DO WHAT THE DOCUMENTS SAY
Third, for gosh sakes, be sure to follow your own procedures. It’s the easiest thing in the world for an FDA inspector to cite your company (that is, make an inspectional observation) for your failure to follow your own written procedures. There are a lot of interesting policy debates one could have about the wisdom or necessity of any particular detail of a company’s safety plan or preventive controls, but those debates really don’t matter if you said in your own SOP that you would check the temperature of your cake mix after baking, but didn’t do so.

DOCUMENTS AND RECALLS
Finally, documentation is relevant to recalls in at least two important senses. One is that the company will have in place the requisite recall plan, having thought through in advance the necessary steps to undertake or consider when problems arise. The value of preparing in advance cannot be underestimated, particularly because circumstances in which safety concerns arise or are suspected can be high-pressure, fluid, and even emotionally charged.
Second, of course, documentation of production can help a company identify causes or potential causes and define a limited scope for the affected product, and then identify the consignees who received the product within that scope. Without such documentation, the prospect exists that a company might decide its only reasonable option is to recall everything it’s made that is still out in commerce, which is often a very expensive and burdensome option.

Have more questions about documentation or would like to get in touch with the author? Contact ConnectFood.

About the Author:


Eric F. Greenberg is Principal Attorney of the law firm Eric F. Greenberg, P.C., with a practice concentrated in food and drug law, packaging law, and commercial litigation.

His food and drug work has included regulatory counseling, label and claims review, new product development, GRAS and food contact materials evaluations and clearances, negotiations with the U.S. Food and Drug Administration and state agencies, handling recalls, and defending enforcement actions.

In addition to his law practice, Eric is a member of the Adjunct Faculty of the Chicago-Kent College of Law, where he teaches Food and Drug Law and Administrative Law, and graduate and undergraduate Packaging Law and Regulation at California Polytechnic State University (CalPoly).

Eric wrote the book, Guide to Packaging Law, the Second Edition of which was published in October 2007. He serves as Legal Editor and monthly legal columnist for Packaging World Magazine. Eric has served as General Counsel of the Contract Packaging Association for over 15 years. His firm is based in Chicago and represents clients based all over the world.

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Enforcement Reports for Class II and Class III Recalls Offer Help to the Food Industry

I subscribe to alerts for Class I recalls from the Food and Drug Administration (FDA). The message goes to my email with a link to the press release. It’s a great automated system, and the number of alerts is small enough to manage daily in email. The FDA recalls more than just food – their recalls include biologics (medical products), animal health products (pet food), medical devices, drugs, cosmetics and tobacco. I didn’t sign up for everything, and the subject of the emails I receive helps me decide which ones I can delete without opening… efficient.

Class I recalls are announced when there is a large possibility a consumer will become ill or be injured from a food they have ingested; think of glass shards or pathogens in food. This is where the food industry spends research dollars and companies take measures to prevent biological, chemical, and physical hazards. Class I recalls are the ones we see in social media, which are heavily communicated on the news and posted about on the FDA website. Class I recalls must be entered into the Reportable Food Registry. Do you know what hazard is the number one cause of Class I recalls? The answer is… allergens: a chemical hazard. You cannot put too many resources into allergen management if your product contains an allergen.

I was recently reminded by a colleague to keep up with the Class I notices (done!) and enforcement reports. Hmmm, enforcement reports? In FDA’s words:

    “All recalls monitored by FDA are included in the Enforcement Report once they are classified and may be listed prior to classification when FDA determines the firm’s removal or correction of a marketed product(s) meets the definition of a recall. Once FDA completes the hazard assessment, the Enforcement Report entry will be updated with the recall classification.”

“Classified” does not mean the recall is top secret! There are three classes; Class I is discussed above as the most serious among the classes. A Class II recall is a situation where the probability of illness or injury is remote. Only the manufacturer can make the call on if the recall will be classified as Class I or II based upon the specifics of what went wrong. The situation has a possibility of illness or injury, but the chances are so small that the conditions for illness or injury are unusual or unlikely. A Class III recall is not likely to cause any illness or injury. Period. It absolutely will not happen. The fourth option in an enforcement report is “pending.” This means the FDA is still considering the class for the recall. You would think this is pretty straight forward, but recalls are one big bell curve. Class I and Class III extremes are easy to get right, but there is a huge bump in the middle for Class II. This leads me to the FDA website.

Enforcement reports are posted weekly. When you go to the previous link, click on the week of interest, then sort with the ‘Product Type’ dropdown menu for ‘Food’ or another category. Dietary supplements are posted under ‘Food,’ even though they are not food and are separately regulated. If you really want a scare, choose the category of ‘Drugs’ to see all the problems in that industry, or see pending recalls of drugs. In addition to the Class I recalls, the other classes are of interest as well.

We use enforcement reports to keep up with our industry. What problems do others in your commodity experience? When we read the Class II and Class III recalls, we see what problems are occurring in our industry. Are you in dairy, flour, nuts, or produce? Look for companies with similar commodities as both your ingredients and your products. As part of reviewing your written food safety plan, the food safety team is required to keep up with current science and potential hazards. One way to know what is going on in your commodity is to keep up with enforcement reports.

Have you heard all the recalls of pet food? These are not coming to my email, so I need to update my alerts. The ConnectFood website has free resources, including the ability to create a recall plan for your facility and products using the online software. 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

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2017 Illinois Food Safety Symposium: A Review

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.

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Recall: Lessons Learned – Part 2

In a previous ConnectFood blog, Recalls: Lessons Learned, I wrote about some personal experience working with industry during recalls. I discussed:

  • Are you sure you must initiate a recall?
  • Get yourself a good lawyer.
  • Don’t move that product!

There are two important reasons to have a written recall plan. First, the rule requires it, and, second, the written recall plan will get you organized in the case of an actual recall.

There is a requirement for a written recall plan in the rule, Current Good Manufacturing Practice, Hazard Analysis, and Risk-based Preventive Controls for Human Food. In Subpart C of the rule, any facility that manufactures, processes, packs, or holds food must complete a written hazard analysis. There are facilities which are exempt from a hazard analysis. Farms are exempt. Facilities earning an average of less than $1,000,000 in revenue are exempt. Food service operations like grocery stores and restaurants are exempt. If a food facility does not perform a hazard analysis, the facility must provide evidence of oversight by a non-federal entity, like a state department of agriculture or a local health department.

It is in the hazard analysis that hazards requiring a preventive control are identified. Right up front in Subpart C we see the Contents of a food safety plan

, and (4) The written recall plan as required by § 117.139(a).

Turning to 21 CFR 117.139(a), we see Recall plan.
For food with a hazard requiring a preventive control:
Does your product potentially have a hazard? Have you identified a hazard requiring a preventive control in the hazard analysis? If you have a ready-to-eat product, you have a hazard, namely an environmental pathogen. If your product has an allergen, you have a hazard. Does your process have metal-on-metal or other physical hazards?

If you have identified a hazard requiring a preventive control in the hazard analysis, you must have a written recall plan as part of your food safety plan.

The recall plan must include written procedures which the company will follow in the event of a recall. Most recalls are announced on Fridays, and then it is all hands-on-deck. The recall plan must name the position of who will do each procedure. You can include names and contact numbers in the recall plan; just remember to keep it updated. Here are some examples. Who is the:

  1. Single person to initiate the recall. Who has the responsibility to pull the trigger on a recall?
  2. Internal recall coordinator. This person may not be a Preventive Controls Qualified Individual.
  3. FDA recall coordinator
  4. State recall coordinator
  5. Accountant. A recall is going to be costly.
  6. Attorney or firm for the recall. Find an attorney who has recall experience.
  7. Contact for communication to the public and press. The public must be notified of the hazard.
  8. Sales personnel who must notify each customer, communicate if the product is to be returned or disposed, and calculate the daily effectiveness check which accounts for how much product has been recovered.

A team of experts must decide the fate of the recalled food. The company will work with the state and/or FDA recall coordinator, attorney, quality assurance personnel, and contract lab. The company may hire a consultant to investigate the cause of the hazard and advise through the recall. If a plan is developed for the food to be reconditioned, reprocessed including relabeling, reworked, diverted, or destroyed, the company will present the plan to the FDA for acceptance.

A mock recall is not required, but highly encouraged.

A mock recall is when the recall team tests and updates the information in the written recall plan. I was reviewing a food safety plan with a client, and we came to the recall plan section. The quality manager informed me that she had just emailed with the FDA recall coordinator during the previous week, when I asked about mock recalls and the testing of the plan. The contact information was on the email signature for the FDA recall coordinator. On a whim, I said let’s call the number. The recorded message told us that the person could no longer be reached!

Since the mock recall is not required, the company will determine the frequency of the mock recall and if the date is announced or surprise. There are advantages and disadvantages both ways. The important concept in a mock recall is to go one step back to the source of an ingredient and one step forward to your customers. For every mock recall you do, take the practice seriously, and you will learn more about your systems and become more organized in your company.

Unfortunately, food recalls are an every-day occurrence in the food industry. Not only is a written plan required by law, but the written recall plan will help your company be organized in the case of an actual recall.

The search for forms and checklists can be overwhelming. The ConnectFood website has free resources. After you sign in for free, you will have access to forms and checklists. The folks 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.

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Recalls: Lessons Learned

In the last year, I have worked side-by-side with industry folks as they navigate the aftermath of a recall. Every recall is unique and presents its own unique challenges, but here are some lessons I learned and can share with you. That is, most of this experience remains confidential.

Are you sure you must initiate a recall?
As a food microbiologist with expertise in lab methods, you need someone on board who understands the testing methods. You can find this expertise with your contract lab or with a consultant, if you don’t have it in-house. If you are initiating a recall due to a pathogen, you need to understand that these tests are comprised of many steps, and therefore days, before a positive pathogen test is confirmed. If that concept is foreign to you, find your person who is going to ask what method was performed and what was the result at every step. Where was the test performed and by whom? Labs make mistakes! Be absolutely certain that the positive pathogen result is true before initiating a recall. I have a story about this that is so bad, I can’t even put it in writing. Warning: be very certain.

Get yourself a good lawyer.
My cousin Vinny is not qualified to be your recall lawyer. Most companies use an outside lawyer or firm for business dealings on a routine basis. Your company attorney may be a relative or friend. This is not the person to work with you in a recall. The lawyer must have experience communicating with FDA. I have heard stories of lawyers thinking they are going to strong arm the FDA, they tell off the FDA, and the food facility just gets greater scrutiny and ends up doing even more work for the FDA. There are lawyers and firms who specialize entirely in working with the food industry and its government agencies. Hire a great recall lawyer. It is going to cost you a lot of money. Recalls cost a lot of money. If you want to fix the problem and resume operations, hire a great food recall lawyer.

Don’t move that product!
After a recall has been initiated with the codes of the recalled product, you probably will have product on site. It will be in the way. You will want to move it out of the way and into long-term storage. Don’t move that product, unless you have written permission from your state or federal recall coordinator. From my experience with product contaminated with a pathogen, that product is now considered hazardous material and must be handled as hazardous material. First, that means you must protect your workers, so that they do not become contaminated. The recall coordinator will want to know how much product was produced, where it went, and how much is under your control on-site or in company-owned warehousing. Once you have that information, you may present a plan for storage and moving the product into storage. To move the product during a recall looks nefarious, and you do not need any extra headaches during the recall.

Unfortunately, food recalls are an every-day occurrence and no company is exempt from the possibility. As much as possible, be prepared. If you are in a recall, be smart. I hope you can learn from these lessons.

The search for forms and checklists can be overwhelming. The ConnectFood website has free resources. After you sign in for free, you will have access to forms and checklists. The folks at ConnectFood are here to help! Contact us.

For more about recall plans, read part two of this blog.

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.

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