Tim Cser, Millipore

Enter the New Era of Media Preparation

By Food Safety Tech Staff
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Tim Cser, Millipore

Q: What are the current challenges with media preparation?
Tim Cser: Dehydrated culture media has been around since the mid-1800’s. Louis Pasteur is widely credited with creating the first media of yeast, ash, candy sugar and ammonium salts. In fact, Merck/MilliporeSigma has the first patent on culture media in 1885! This same idea has been a backbone of microbiology since its inception. However, getting the culture media into a usable format has always had its challenges. Ubiquitous around the globe, culture media is the simplest, most cost-effective way to grow and study microbes. Some media, like Tryptic Soy Broth (TSB), is already formulated and ready to weigh, mix and autoclave. Other media require raw materials to be mixed together from scratch, requiring quite a bit of time and man hours. Weighing the media requires a calibrated balance, scoops, storage, a mixing hotplate, an autoclave, Erlenmeyer flasks, bottles, etc… a classic media kitchen. In addition, weighing the powder can be a messy process, creating dust inhalation concerns. MilliporeSigma helps solve some of that with our granulated media (think sugar vs flour) that produces at least 70% less dust and is much easier to weigh and pour. Each step requires human interaction from weighing to removing it from the autoclave. Then, once it’s ready to be used, often times it needs to be re-heated to a higher temperature.

Q: How does the ReadyStream system address those challenges?
Cser: The ReadyStream® instrument streamlines the media preparation process by eliminating the need for an autoclave, balance, glassware, hotplate, etc. The sterile granulated media comes in a vacuum-sealed, irradiated pouch that gets hydrated and heated at the same time. The ReadyStream® uses sterile, filtered water to rehydrate the media, creating a ready to use broth in about 30 minutes. Once the media is fully dissolved and ready to be dispensed, it can then be ready within minutes over the course of 5 days allowing the lab flexibility with sample preparation. The ReadyStream® impacts the entire media preparation process by eliminating weighing (in a hood), hotplate mixing, autoclaving, cooling, handling hot glass, pre-heating before use, bottle washing and more. The ReadyStream saves the lab significant time and money in addition to power and resources. There is nothing else on the market that creates a pre-heated, sterile medium stored at room temperature, ready to use at a moment’s notice. The ReadyStream® has modernized the media preparation process.

For more information or to schedule a live demo, visit www.SigmaAldrich.com/ReadyStream or email NABioMFMSupport@MilliporeSigma.com for an exclusive sneak peak of the instrument!

Content Sponsored By:

MilliporeSigma

FDA

FDA Wants to Change Agricultural Water Requirements in Produce Safety Rule

By Food Safety Tech Staff
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FDA

After years of foodborne illness outbreaks that have been suspected to originate in pre-harvest agricultural water, FDA is proposing changes to the FSMA Produce Safety Rule. The proposed rule would revise subpart E, changing certain pre-harvest agricultural water requirements for covered produce other than sprouts.

“There have been far too many foodborne illness outbreaks possibly linked to pre-harvest agricultural water in recent years, including water coming from lands nearby produce farms. As a federal government agency charged with protecting public health, the FDA is committed to implementing effective modern, science-based measures designed to prevent these outbreaks from occurring in the future,” said Frank Yiannas, FDA Deputy Commissioner for Food Policy and Response in an agency update. “The proposed rule is the latest action taken by the FDA to continue working towards implementation of key provisions of FSMA. If finalized, we’re confident this proposal would result in fewer outbreaks in the U.S. related to produce, protecting public health and saving lives. This proposed rule is a monumental step towards further improving the safety of the fruits and vegetables Americans serve their families every day, and the FDA looks forward to engaging with stakeholders on the proposed changes.”

Under the proposed rule, farms would be required to conduct yearly systems-based agricultural water assessments to assess and guide measures that would reduce risks related to pre-harvest agricultural water. According to the FDA, the assessment would consist of evaluating the water system, agricultural water use practices, crop characteristics, environmental conditions, potential impacts on source water by activities conducted on adjacent and nearby land.

With the current agricultural water compliance dates for covered produce other than sprouts set to begin in January 2022, the FDA plans to exercise enforcement discretion for those requirements while also proposing another rule that extends the compliance dates for all agricultural water requirements under the Produce Safety Rule.

The full details of the FSMA Proposed Rule on Agricultural Water are available on FDA’s website.

FDA

FDA Publishes Long-Awaited Final Rule on Lab Accreditation

By Food Safety Tech Staff
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FDA

At long last FDA has issued its final rule for Laboratory Accreditation for Analyses of Foods (LAAF). The FSMA rule establishes a lab accreditation program for testing food in certain situations and applies only to accredited bodies and food testing labs that opt to participate in the program; these ABs and labs must fulfill certain eligibility requirements.

“The establishment of the LAAF program will improve the FDA’s capacity to protect U.S. consumers from unsafe food by improving the accuracy and reliability of certain food testing through the uniformity of standards and enhanced oversight of participating laboratories,” CFSAN states in a news release.

According to CFSAN, the LAAF will apply to testing that is:

  • “to support removal of a food from an import alert through successful consecutive testing requirements;
  • to support admission of an imported food detained at the border because it is or appears to be in violation of the Federal Food, Drug, and Cosmetic Act;
  • required by existing FDA food safety regulations, when applied to address an identified or suspected food safety problem (i.e., certain tests of shell eggs, sprouts, and bottled drinking water);
  • required by a directed food laboratory order, a new procedure being implemented in this final rule that will allow the FDA to require use of a LAAF-accredited laboratory to address an identified or suspected food safety problem in certain, rare circumstances; and
  • conducted in connection with certain administrative processes such as testing submitted in connection with an appeal of an administrative detention order.”

The final rule will be published on the Federal Register on December 3.

Recall

Q3 Food Recalls Drop More than 10%, 2021 Could See Lowest Recall Levels in a Decade

By Maria Fontanazza
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Recall

FDA food recalls fell more than 11% and USDA recalls increased by just one recall in Q3. If this decreased activity continues, 2021 food recalls could fall to their lowest levels in more than a decade.

The drop in recalls is good news, but food companies remain challenged in maintaining and implementing effective employee training. “Health and safety risks related to the coronavirus, combined with labor shortages, mean that companies must double down on training, communication, and accountability, particularly in cases where employees have never worked in food manufacturing,” according to Sedgwick’s Q3 update on U.S. recalls. “All the right protocols and procedures can be in place, but without a skilled workforce and commitment to continuous improvement, no number of written policies and procedures will prove effective. Companies and their quality and safety teams must be ready, willing, and able to embrace new technologies and evolve with new regulatory guidance as the industry innovates.”

FDA Recalls: Notable Numbers (Q3 2021)

  • Recall activity dropped from 106 recalls in Q2 to 94 recalls (11.3% decline)
  • Prepared foods and produce were top categories for recalls, with 13 events each
  • Recalls affected 2.4 million units, a nearly 70% drop from Q2 (7.9 million units)
  • 33% of recalls were Class I
  • Undeclared allergens was leading cause of recall, with milk being the main cause
  • Bacterial contamination came in second for amount of recalls at 25, followed by quality concerns at 11 recalls

USDA Recalls: Notable Numbers (Q3 2021)

  • Recalls increased from 12 to 13 events (quarter-over-quarter)
  • Number of pounds increased from 207,000 pounds to 10.7 million pounds (due to a single recall of ready-to-eat poultry products that affected almost 9 million pounds)
  • Bacterial contamination was the top cause of recalls—Listeria, Salmonella, and E.coli were the named pathogens of concern
  • Eight recalls were due to undeclared allergens
  • Poultry products the most impacted product category

In November alone, there were nine recalls as a result of foreign matter contamination. Learn more about the strategies companies should implement to prevent and detect foreign materials during Food Safety Tech’s upcoming virtual event, “Food Safety Hazards: Physical Hazards”. | Thursday, December 16 at 12 pm ET.

Megan Coy-Moran, AIB

Be Confident in Your PCQI’s Training

By Megan Coy Moran
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Megan Coy-Moran, AIB

With allergens being the leading cause of recalls in the U.S., accounting for approximately 47 percent of recalls as of the most recent FDA reportable food registry annual report, FDA has placed “an emphasis on preventing allergen contamination, protecting consumers, and reducing the need for food recalls.” So, when FDA makes allergen control a priority, how can you be confident that it is a priority for your team and in your facility? By providing your designated Preventive Controls Qualified Individual (PCQI) with the right PCQI training.

Introduced in the Preventative Controls for Human Food Regulation final rule that exists within the FDA’s Food Safety Modernization Act (FSMA), a PCQI is required to be on staff in all food and beverage facilities registered under section 415 of the Federal Food, Drug, and Cosmetic Act (FD&C) Act. In this role, the PCQI oversees development of the Food Safety Plan, hazard analysis, preventive controls, verification activities, and validation of process preventive controls. Further, FSMA mandates that all food manufacturing facilities conduct Hazard analysis and risk-based preventive controls (HARPC), while also implementing science-based preventive control measures to reduce the potential risk of food product adulteration. Each of these are managed by the PCQI and critical to achieving food safety.

With the goal of preventing foodborne illness and maintaining compliance with the FDA, the PCQI also needs to possess an in-depth knowledge of the facility’s Environmental Monitoring Program, food allergen controls, sanitation controls, supply chain controls, and recall plan. The importance of the PCQI’s many responsibilities means they need to have the necessary training and skills for the creation, application, and verification of these and other measures as applicable to their facility.

The PCQI’s oversight and familiarity with the Food Safety Plan also suggests they are likely the primary contact when FDA arrives at your facility for an inspection. Their ability to answer the inspector’s questions and successfully manage this process helps ensure that those visits are as concise and positive as possible. Having this single point of contact is also beneficial for the inspector, as they know they can count on the PCQI as a resource to provide them with necessary information without having to chase down multiple sources. Too, having a PCQI on site makes it easier to then implement regulatory requirements and any necessary preventive controls within the designated time, as they are already familiar with the facility and team.

The best PCQI training will prompt participants to think through real-world scenarios, preparing them to identify best practices to achieve food safety. By then putting this theory into practice in their facilities, they will help ensure compliance. Further, it is important that any course they take features consistently updated information, so you can be assured that what they are being trained on is current and accurate. For instance, when the U.S. Congress passed and President Biden signed the FASTER Act into law in April 2021, including sesame as an allergen of concern, this was an important update. As new information becomes available, their training should remain timely and accurate, ensuring that the experience is relevant and responsive to changing regulations.

Because production right now is priority and many teams are short-staffed, it can be difficult for some to find the time to travel to participate in an in-person training course. This makes online training appealing, as it can be completed when time becomes available, while also saving on travel costs.

With the right training, your PCQI will be an invaluable member of your team. By aligning priorities with regulators and prioritizing food safety throughout their responsibilities, they will improve your facility’s ability to produce safe food.

With our PCQI Online training, your PCQI will be an invaluable member of your team. By aligning priorities with regulators and prioritizing food safety throughout their responsibilities, they will improve your facility’s ability to produce safe food.

lightbulb, innovation

Upcoming Webinar Highlights How Standards Support the Food Supply Chain

By Food Safety Tech Staff
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lightbulb, innovation

Join Food Safety Tech and food safety leaders from BSI for a 60-minute webinar on “Food Safety & Quality: How Standards Support the Food Supply Chain” on Monday, December 13. Sponsored by Intelex, the complimentary event will educate attendees about key standards in ensuring food safety and quality in the supply chain—including ISO 22000, ISO 9001 and the new cold chain logistics standard, ISO 23412:2020, which addresses indirect, temperature-controlled refrigerated delivery services. Featured speakers are Sara Walton, sector lead (food) – standards at BSI, and Amanda McCarthy, chair of AW/90, quality systems for food industry at BSI. The event begins at 12 pm ET. Register now!

Food Safety Tech Survey: Are You Ready to Return to Corporate Travel?

By Food Safety Tech Staff
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Business travel took a significant hit last year and 2021 has yet to see a rebound. Over the past two years, Food Safety Tech has strived to continue to educate the food safety community without missing a beat—in both 2020 and 2021 we converted our annual Food Safety Consortium into a virtual event series, and we ramped up our other web seminars.

As we look ahead to 2022, we are planning a great lineup of virtual events. However, we also want to get a feel for our audience’s comfort level in getting back to traveling for business—and even if you’re comfortable traveling, is there money in the budget for it?

As a valued member of the food safety community, we invite you to participate in the following brief survey. As a show of appreciation, you will be entered into a drawing for a chance to win a free registration for the 2022 Food Safety Consortium.

Create your own user feedback survey

Robert Califf, FDA

President Biden to Make Nomination for FDA Commissioner and USDA Food Safety Head

By Food Safety Tech Staff
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Robert Califf, FDA

President Biden plans to nominate former FDA Commissioner Robert Califf, M.D. to lead the agency once again—in an announcement mainly focused on clinical trials, vaccine approvals, and ending the coronavirus pandemic. Califf briefly served as FDA commissioner in 2016. His tenure was less than a year.

Perhaps more significant news for the food industry is the President’s intent to nominate Jose Emilio Esteban, Ph.D. to the post of undersecretary for food safety at the USDA. Esteban is currently the chief scientist for FSIS and has been in this role since 2018; he has served in the USDA’s FSIS since 2006. Before his time at the agency, he worked for the CDC.

The Senate must confirm both positions.

FDA

Online Food Shopping Becomes New Normal for Consumers, FDA to Ramp Up Food Safety Efforts

By Food Safety Tech Staff
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FDA

Online grocery shopping became essential during the early months of the COVID-19 pandemic. While many consumers have returned to the brick and mortar stores, many others have completely changed how they shop for food, opting for online shopping, whether out of convenience or for safety. The FDA has seen and recognizes this shift and even held a three-day virtual summit last month, “The FDA New Era of Smarter Food Safety Summit on E-Commerce: Ensuring the Safety of Foods Ordered Online and Delivered Directly to Consumers”, to discuss and gain insights into the world of business to consumer e-commerce involving food.

“It is now clear that this is not a trend that will be completely reversed in time but one likely to lead to a new normal in how consumers shop for food, whether it’s from restaurants, grocery stores, or companies providing meal kits and other products,” state Frank Yiannas, deputy commissioner for food policy and response at FDA and Andreas Keller, director, multi-commodity foods, Office of Food Safety at CFSAN on the FDA Voices blog. “Thus, the U.S. Food and Drug Administration is actively working with partners in federal, state, and local government and industry in the U.S. and other nations, as well as with consumer advocates, to help ensure that consumers aren’t ever unwittingly trading food safety for convenience.”

During last month’s meeting, many challenges and questions came up, from how to further prevent food tampering to labeling issues, especially related to allergens, to ensuring that food safety values are shared across all parties involved in producing, transporting and selling food in the e-commerce setting.

FDA announced that it will be reviewing and assessing the information it received during the meeting and is inviting industry to submit public comments now through November 20, 2021 (Docket FDA-2021-N-0929). From there, the agency will determine the critical issues that need to be addressed first.

The daily recordings of the virtual summit are available on FDA’s website.

CIJ

Infused Products Virtual Conference to Tackle Safety and Quality

By Food Safety Tech Staff
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CIJ

State regulations shouldn’t be the reason why infused products manufacturers have robust safety and quality standards—consumer safety is. Join Cannabis Industry Journal for a complimentary event, “Infused Products Virtual Conference”, on November 16 at 12 pm ET.

The following are some agenda highlights:

  • Where to Begin: Leveraging Quality Systems to Improve Operations & Growth, with David Vaillencourt, The GMP Collective and Kathleen Mays, Triskele Quality Solutions
  • 3 Steps to Create a Compliance Culture with Operational Excellence, with Dede Perkins, ProCanna
  • Innovation from an Outside Perspective – For the Purpose of Building Infused & CBD Product Success, with Jerod Martin, CannGoods
  • Implementing Food Safety Management Systems in Infused Products Production Facilities, with Dr. Laurie Post, Deibel Labs
  • ICP-MS Analysis of Heavy Metals in Cannabis Containing Food and Cosmetics Using CRM Mixes, A TechTalk sponsored by MilliporeSigma

Register for the Infused Products Virtual Conference by Cannabis Industry Journal.