FDA Inspections: Where are We Going?

Not only has COVID put a significant dent in our social lives, but it also has impacted many operations and practices throughout food processing facilities. Unfortunately, this includes one area that has consumers worried, inspections of food facilities. With all the new requirements and protocols that have come out of this pandemic, the industry has had to learn to alter their inspections. Some are even using video technology as a substitute. With COVID laying a foundation that will likely alter the way inspections are completed in the future, what should processing facilities across the country expect moving forward?

According to the FDA, inspectors are “required to inspect facilities that handle high-risk foods every three years. Facilities handling foods not deemed high-risk must be inspected every five years” (Fox, 2019, pp. 13). With being in the midst of a global pandemic, the FDA has halted these inspections, but is still conducting some necessary inspections for specific scenarios like outbreaks of foodborne illness and Class 1 recalls. 

To temporarily replace in-person inspections, many auditors are allowing for special accommodations to be made such as remote and hybrid audits (Black, 2021, pp. 5).

Aside from the FDA, other auditors such as BRCGS and SQFI are offering blended options. BRCGS is offering certificate extensions for up to 6 months with a risk assessment and review. Remote assessments are also available and require a video audit of the facilities storage and production spaces. SQFI is postponing certifications for extenuating circumstances and have implemented additional processes for risk assessment (Black, 2021, pp. 7). For more information on other auditors current COVID policies, click here.

Once in-person audits can resume in the future, the FDA plans to host pre-announced audits for FDA-regulated businesses. According to an interview with Frank Yiannas, it is predicted that health and safety are going to be important factors moving forward with inspections. It is also assumed that consumers are going to want to know not only how their food is produced, but also how it will be safe enough for them to eat. Fortunately, the FDA is in the works of implementing a Smarter Food safety initiative that will allow for a digital way to trace the food system (U.S. food & Drug Admin., 2020, pp. 31).

As for now it seems unknown when in-person audits will fully resume. The FDA stated in a press release that they will likely resume when there is a consistent downward trend in new COVID cases and hospitalizations in geographic areas they are working in (2020, pp. 6). Until then, they will continue to make significant strives with food safety, making it stronger than ever.

Sources:

Black, J. (2021, January 29). Food Safety Audits During a Pandemic: What You Should Know and How to Prepare. FoodSafetyTech. https://foodsafetytech.com/column/food-safety-audits-during-a-pandemic-what-you-should-know-and-how-to-prepare/.

FDA. (2020, April 16). Food Safety and Availability During and Beyond COVID-19. U.S. Food and Drug Administration. https://www.fda.gov/food/conversations-experts-food-topics/fdas-perspective-food-safety-and-availability-during-and-beyond-covid-19.

Fox, M. (2019, January 15). FDA to resume food safety inspections Tuesday. NBC News. https://www.nbcnews.com/health/health-news/fda-resume-food-safety-inspections-tuesday-n958631.

Hahn, S. M. (2020, July 10). Coronavirus (COVID-19) Update: FDA prepares for resumption of domestic inspections with new risk assessment system. U.S. Food and Drug Administration. https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-prepares-resumption-domestic-inspections-new-risk-assessment-system.

 Sjerven, J. (2021, January 21). COVID-19 forces FDA to alter food safety inspection practices. Food Business News. https://www.foodbusinessnews.net/articles/15740-covid-19-forces-fda-to-alter-food-safety-inspection-practices.
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The Food Safety Modernization Act: An Undertaking in Progress

Ten years…that’s a long time, right?  But…not really.  The more I see 10th, 20th, or 25th anniversary releases of favorite albums or movies, the more I feel like time is slipping away…and ten years seems more like a blink.   So, when you consider the dichotomy of the slow and all-too-quick hands of time, it’s impressive how much has been accomplished, and yet how far we have to go in food safety since the Food Safety Modernization Act was enacted in early 2011.   

As much as it would be great to go with either a “yay” or “nay” as to whether it has been a success, like many pieces of major legislation, there have been both phenomenal strides as well as stagnation.  As food safety is a complex undertaking, involving waves of domestic and global political and trade relations, budgetary concerns, etc., the quality assurance of the Act itself can be a challenge at times.  As we’ll see though, overwhelmingly, FSMA has represented a tectonic shift in approaching food safety concerns, and has set the table (yes, that just happened) for increasing advances in the coming years.

The data suggests that we do have a long way to go.  The CDC succinctly summarized this in “Preliminary Incidence and Trends of Infections with Pathogens Transmitted Commonly Through Food — Foodborne Diseases Active Surveillance Network, 10 U.S. Sites, 2016–2019” stating that: “The incidence of most infections transmitted commonly through food has not declined for many years.”  Although disappointing to those invested and concerned about food safety, it is important to remember that FSMA is not a stagnant absolute, existing in a vacuum of regulatory comfort.

Instead, FSMA, like food safety itself, is a continuously evolving and changing entity.  To respond to new science and to new challenges, FSMA depends on building on foundational scientific knowledge, while adeptly adjusting to the reality of challenges of the time (COVID-19 being a great example).  Though there is a long way to go, FSMA has achieved numerous outcomes that have been important to the industry and to the march towards a safer food system.   

As Sandra Eskin, of Pew Charitable Trusts, noted in a recent food safety session at IDFA’s Dairy Forum, the reality is that while FSMA is ten years old, the compliance dates established to meet the goals of FSMA are only now a few years old. This complicates our “FSMA at 10” theme a bit, but we can surmise a great deal from both those years of buildup and those of ennactation/enforcement.   Here is a sampling of what has been accomplished by FSMA so far, as outlined by Deputy Commissioner of Food Safety Frank Yiannas in his “A Decade Later, FDA Still Working on Congressional Mandate Known as FSMA:”

  1. Food producers “must have food safety plans that include an analysis of hazards and risk-based preventive controls to minimize or prevent these hazards.”  
  2. Improved “regulatory oversight of produce and food importers.”
  3. Implemented practices to prevent food safety risks during transportation.
  4. Gained: “additional enforcement authorities, such as mandatory recall when a manufacturer fails to voluntarily pull unsafe food from the market and suspension of registration to prevent a facility from selling or distributing unsafe food.

To add to these and other advances, the FDA this year encouragingly released their “New Era of Food Safety” blueprint, laying out areas of development in the next decade of FSMA.   Along with increased traceability initiatives, meaningful use of technology, and business/retail model modernization, the blueprint centrally is built upon creating “food safety cultures.”  This means making food safety a shared goal by everyone in the plant, in the supply chain, and beyond—top down and bottom up investment–everyone is in on it.  This should further encourage that “tectonic shift” mentioned previously, fundamentally shifting existing perspectives on food safety in the industry.  The ability to shape the future of food safety and cultures of food safety will be dependent on education, industry/regulatory/academic partnership, collaboration, and advocacy on Capitol Hill, just as the shifting of views from reactionary to preventative action required these first ten years.  

As Dick Groves stated in his editorial in the Jan. 15th issue of The Cheese Reporter, “Simply put, the food safety culture matters more than regulations.”  Groves makes a good point about the centrality of food safety culture; however, perhaps it is a mixture of conceptual shifts and continued dependence on education and partnership to further spread the gospel of food safety and regulatory knowledge/standards (consider that not having an adequate hazard analysis is still one of the most commonly cited violations by the FDA) that will make the next ten years truly effective in the fight against foodborne illness. 

Ten years indeed can feel conversely like an eternity and a blink of an eye.  The first decade of FSMA has been an experiment in adaptation.  And it will continue to be so for the next ten, marrying the realities of regulatory standards with an embrace of a holistic framework of food safety and food safety culture at all levels (including establishing this at the federal level…which is crucial for funding).  Together we can continue to learn, improve, and work together towards this common goal.  Food safety is not a destination, it is a journey.  We must continue working together as an industry to reduce risk in the food supply chain, relentlessly combatting foodborne illness.  No matter how far we are able to push that boulder up the hill, there will always be further to go. Many hands make light work, though, so let’s all commit to the effort and make the next 10 years count.

Source(s):

Marler Clark. (2021, February 9). FDA’s data for 2020 shows top five violation categories at food facilities. Food Safety News. https://www.foodsafetynews.com/2021/02/fdas-data-for-2020-shows-top-five-violation-categories-at-food-facilities/?utm_source=Food%2BSafety%2BNews&utm_campaign=280373c947-RSS_EMAIL_CAMPAIGN&utm_medium=email&utm_term=0_f46cc10150-280373c947-40046447#.

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Knowledge at Your Fingertips

Resources made available with Nelson-Jameson’s Learning Center! This educational learning library was created to encourage our customers to seek out information, when applicable, to aid them in making informed purchasing decisions within the food, dairy, and beverage industries. By providing this free resource for anyone to use, our goal is to have you feel comfortable and confident in the products you purchase.

An intriguing aspect of our Learning Center is that the information we are providing is supplied to us by manufacturers, and industry associations. It is our goal to relay to you the most up-to-date information for your convenience. The information within this resource falls into several categories: Laboratory & QA/QC, Packaging & IngredientsProcess & Flow ControlSafety, and Sanitation & Maintenance. Within each of these 5 areas, there is a range of subtopics that we determined were important for our customers to expand their knowledge on. Here is a brief overview of each of these sections:

Laboratory & QA/QC: We offer food safety products and solutions that help the food and beverage industries protect the quality of their products by utilizing proven, methods-based laboratory procedures. Learn more about Hydrating 3M™ Petrifilm Plates, pH Electrode Selection Guide, pH Testing Tips, and Nelson-Jameson pH Buffers, and more.
Packaging & Ingredients: Food safety begins with quality ingredients and packaging. Learn more information about our wide line of food and dairy ingredients, Choosing Cheese Packaging, Selecting Cultures & Coagulants for Taste & Texture, and Packaging Films.
Process & Flow Control: Keep food and beverage production running smoothly. Learn more from these resources designed to help meet your unique food, dairy, and beverage needs, such as Hose Maintenance Tips, Gaskets, Pump Maintenance, and Filtration Ratings.
Safety: In the food, dairy, and beverage industries, it is important to protect employees from injury and food product from possible contamination. To protect your assets, learn more about Noise Reduction Ratings, Protective Clothing Materials, Footwear Sizing, and peruse our Glove Selection Guide.
Sanitation & Maintenance: Keep your plant clean and safe with quality sanitation and janitorial products. Learn more about Broom Bristle Options, Insect & Pest Control, and Disinfectant Mats™.

At Nelson-Jameson, we strive to make our customers’ lives easier by providing products, solutions, and technical expertise when needed. Whether it’s figuring out how to clean a tank properly or learning about broom bristle options, Nelson-Jameson is your one stop shop—Click here to view our Learning Center and learn more about our areas of expertise!

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New Year, New Sanitation Program

Achieve an effective sanitation program in your facility with footwear and surface sanitation products! In the food production process, cross-contamination can occur at any point. Employees can track in a myriad of potential contaminants and unknowingly put an operation at risk each time they breeze through a doorway to a production area. Having an effective sanitation program in place that addresses employee hygiene is key.

A primary route of contamination is the bottom of people’s shoes, so cleaning footwear has become just as important as washing hands when coming into a facility. “Items which contact the floor are contaminated and could serve as vectors; despite daily cleaning of high-touch surfaces such as floors, it has already been shown that bacterial and viral contamination return rather quickly” (Pyrek, 2018, pp. 1). To help combat this issue, Nelson-Jameson carries several options for minimizing contamination from footwear including: Boot Scrubbers, Doorway Foamers, and Disinfectant Mats. These products are designed to be located at entryways of facilities to remind employees to clean and sanitize their shoes upon entry.

Cleaning and sanitizing surfaces is also an integral part of a sanitation program. Having the correct sanitizers for your processing facility can prevent the spread of microorganisms that cause foodborne illness. At Nelson-Jameson we have a full line of Alpet® Sanitizers that are both food contact and non-food contact approved for your facility.

Overall, this program is designed to aid in preparing your facility to be sanitized, but you can’t sanitize without cleaning first. It’s apparent that many individuals interchangeably use the terms cleaning and sanitizing, when in fact they are different. Cleaning is described as the physical removal of visible dirt, soil, food particles, grease, or allergens from equipment, utensils, or work surfaces. On the other hand, sanitizing reduces the number of harmful microorganisms from a cleaned surface. Cleaning must always come before sanitizing. If cleaning is skipped, the sanitizing process will be ineffective as oil, grease, and dust deactivate sanitizers. While these products are not guaranteed to remove all bacteria, they do bring the amount down to a safe level.

Start preparing your processing facility today—request or download our updated 12-page Footwear & Surface Sanitation Flyer. It contains an array of products to help make protecting your facility and products easier!

Sources:

Pyrek, K. M. (2018, October 31). Shoe Sole and Floor Contamination: A New Consideration in the Environmental Hygiene Challenge for Hospitals. Infection Control Today.      https://www.infectioncontroltoday.com/view/shoe-sole-and-floor-contamination-new-consideration-environmental-hygiene.

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Happy Holidays from Nelson-Jameson, Inc.

One of the real joys of the holiday season is the opportunity to say thank you! Our entire organization appreciates your partnership and thanks you for your loyalty and goodwill throughout the year. This year has been nothing but ordinary, but Nelson-Jameson would like to recap on the great accomplishments that came with the 2020 year:

New Location: In January, we successfully opened our second Marshfield, WI location, our new corporate office. Due to the significant growth we have experienced over the last several years, we opened this location to accommodate around 90 of our 210 employees to provide them with newly renovated work spaces.

New Website: We are continuing to work our way through transferring our current website to a new, more user-friendly platform. Our goal is to implement our new website to allow for our customers to be able to navigate through with easier searching capabilities.

New Employees: We have significantly grown in employees in 2020. This year has been nothing but ordinary for everyone, but even with working remotely, we have been able to add and fill new positions within various departments throughout the company.

New President: In October, we announced our organization’s new President, Mike Rindy. Mike has worked in the dairy and food industry for more than 34 years. What started as a job in his cousin’s cheese factory back in 1986, turned into a lifelong passion. Since then, Mike has served in various industry roles ranging from technical service to executive management, where he has experience leading diverse teams to achieve outstanding sales and operational results.

Holidays are the perfect time to be thankful for your friends and family. We would like to thank you for being such a good friend to Nelson-Jameson and for allowing us to experience the accomplishments we have in 2020. We appreciate your business and the opportunity to serve you. We look forward to providing you with food industry expertise, food safety programs, regulatory and chain of custody documentation, supplier consolidation, inventory management solutions, and more in the upcoming year! From our family to yours—may your holidays and entire year be filled with peace and happiness!

 

 

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