Tag Archives: FDA

New York State Cheese Manufacturers’ Association Annual Virtual Meeting

The New York State Cheese Manufacturers’ Association Annual Virtual Meeting is designed to benefit all individuals within the dairy industry. This year the program highlights include:

  • NY Dairy Industry Outlook Update
  • Food Safety Update & Cornell Trainings
  • Advantages of Joining NYS Grown & Certified
  • Exploring Taste: from Counter to Cultures
  • FDA Proposed Traceability Rule

The annual meeting is being held virtually through zoom. Register by 2/24 so the association is able to ship the cheese needed for the cheese tasting in a timely manner.

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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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Taking the Initiative to Help Small Business Negotiate the Food Safety Modernization Act (FSMA)

In our efforts to help our customers produce the best safe, quality food that they can, we like to occasionally share resources that may be of use. Below, you will find a link discussing the Food Safety Modernization Act (FSMA) Training and Consultative Service program, (officially titled the Artisan Dairy Producer Foods Safety Initiative). In an effort to assist smaller businesses and producers, the Center for Dairy Research, Dairy Farmers of Wisconsin, and the Wisconsin Cheese Makers Association have come together to provide guidance for small businesses to meet the demands of FSMA compliance. John Lucey, from the Center for Dairy Research discusses the Initiative further here:

https://www.dairyfoods.com/articles/93071-a-collaborative-effort-to-help-small-dairy-manufacturers-meet-safety-guidelines

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FDA’s Food Safety Plan Builder Software

In the demanding everyday life of a food manufacturer it can be hard to slow down and think about the safety of the products being manufactured. Everything from the ingredients that come in the door to the way the product is shipped out to the customer, all have to be monitored for safety. That is what the Food Safety Modernization Act (FSMA) is all about, making sure the ingredients, the process, and how the end product is shipped out reduces the level of risk to the consumer. The manufacturing facility has to ask, what can be done to prevent the various risks in the plant from happening and causing a recall?

A Food Safety Plan is a robust, detailed plan that is meant to anticipate and meet these challenges. A cohesive plan is based on food safety principles which include: hazard analysis, preventative controls, supply-chain programs, and a recall plan. For smaller businesses, putting a Food Safety Plan in place and maintaining that Plan can be daunting. Where do you start? Making sense of the regulatory language can be difficult, making it hard to determine what the FDA is going to be looking for if you were to receive an audit.

After some feedback from the food industry, the FDA created a free software tool, called the Food Safety Plan Builder. It is a tool designed to assist owners/operators of food facilities with the development of food safety plans that are specific to their facilities, and to assist them in meeting the requirements of the current regulations. Using this software is not required by the FDA, but facilities may find it of use as they continue to critically engage their Food Safety Plans.

Filling out all the information that the software requests can be labor intensive but with some effort and investment though, the Builder can act as a great framework to build upon.  According to Eric Edmunds, food safety director with The Acheson Group, “as with any other electronic tool, the product that you get out of it is as good as the information you put into it!”

If you are interested in using this tool here is the website:
https://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm539791.htm

The bottom line is that there are no shortcuts in creating a culture of food safety. Tools like the Builder are excellent resources to engage and assist in implementing comprehensive programs, but don’t make a complete toolbox in themselves. While food law and requirements can be laborious to understand and read they are important to get right. FSMA was created so that food facilities are held responsible for every bit of food safety including the supply chain from one facility to another. The FDA wants food facilities to know that when guidelines are followed and a good a Food Safety Plan is in place they are setting themselves up for success.

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