Tag Archives: FDA

Melody Ge, Corvium
FST Soapbox

Changes in the Food Safety Industry: Face Them or Ignore Them?

By Melody Ge
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Melody Ge, Corvium

“A new era of smarter food safety is coming,” said Frank Yiannas, FDA’s deputy commissioner of food policy and response, at the GFSI Conference 2019 in Nice, France. He went on to explain, “a smarter food safety is people-led, FSMA-based and technology-enabled.” Afterwards, Yiannas announced the need for a greater budget for the FDA to invest in modern food safety for 2020 and beyond.

Now the question is, when this new era comes, are you ready?

The food industry is relatively behind on technology compared to other industries, or even within our daily lives. Take a look at the cell phone you have now compared to what you had 10 years ago; it has come a long way with all of its handy and useful features. Why can’t the food industry also benefit from technology? Of course, every coin has two sides, but no one would deny that technology played a significant role in bringing the world closer and making it more efficient nowadays.

The scary part of change is that it’s hard to predict what and when they will come to us, however, they also force us think outside of the box. Instead of debating whether incorporating advanced technology into our daily operations makes sense, why don’t we take a look at our current processes in place and see where technology can truly help us? We now have the opportunity to take advantage of technology to enhance our food safety and quality culture at our own facility. Here are some thoughts to share.

1. Identify what can be automated in your current process with technology

Certain things just can’t be replaced by technology, such as risk assessment or hazard identification (at least for now). However, inventory, temperature checking, testing results recording, or anything executing a command from you or implementing a part of your SOPs can potentially be automated. Execution is also the part where the most error could occur, and technology can help improve accuracy and consistency. Identify those steps systematically and understand what data needs to be captured to help your food safety management system.

2. Work with your technology developer to build technical requirements

Explain to the technology developer exactly how you want the program to operate daily. List the operating steps along with responsibilities step-by-step, and identify what requirements are needed for each step. Translating the paper SOP to a computer program plays an important role in this transition. Not only does it set the foundation for your future daily operation, but it also ensures that the control parameter is not lost during the transition.

3. Keep the integrity of the food safety management system through verification and validation

Once processing steps are done by technology, it doesn’t mean that we no longer have to do anything. We need to verify and validate the technology with certain frequency to ensure the steps are controlled as intended. Confirming that the software or system is capturing the right data at the right time becomes key to ensure the integrity of control risks is not compromised.

4. Utilize “preventative maintenance” on all technology used on site

Just like all equipment, food safety technology needs a preventive maintenance schedule. Check whether it is properly functioning on a certain frequency based on the safety impact in your process flow and take actions proactively.

5. Learn from your own records

The time saved from traditional ways allows us to have more time for looking at control points and records received to identify areas for continuous improvement. There are many ways of studying the data with modeling and trend analysis based on your own facility situation. Either way, those records are your own supporting documents of any changes or modifications to your food safety management system, as well as strong support to your risk assessment for justifications.

Just like Yiannas said, a smarter food safety system is still FSMA based. The goal has never changed; we want to produce sustainable, safe and high-quality products to our consumers, whether we use traditional or advanced approaches. After all, we are utilizing technology as a modern way to help us enhance and simplify our food safety management system; the outcome from the automated technology is still controlled by us.

So when the era comes, we all want to be ready for it.

2019 Food Safety Supply Chain Conference

FDA to Provide FSMA Update at 2019 Food Safety Supply Chain Conference

By Food Safety Tech Staff
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2019 Food Safety Supply Chain Conference

EDGARTOWN, MA, April 8, 2019 – Innovative Publishing Co., publisher of Food Safety Tech, has announced three speakers from FDA will kick off the 5th Annual Food Safety Supply Chain Conference on May 29–30. Priya Rathnam, Supervisory Consumer Safety Officer, CFSAN; Andrew J. Seaborn, Supervisory Consumer Safety Officer, Division of Import Operations, ORA; and Lisa L. Ross, Consumer Safety Officer, CFSAN (Office of Food Safety, Multi-Commodity Foods, Refrigerated and Frozen Foods Team) will provide the opening presentations on Wednesday, May 29. An interactive Town Hall with attendees will follow.

Lisa Ross, CFSAN, FDA
Lisa L. Ross, Consumer Safety Officer, CFSAN

Seaborn, Rathnam and Ross will provide FDA perspective on FSVP inspection updates, including outcomes and compliance, the voluntary qualified importer program (VQIP) and where the agency is headed with enforcement activities. They will also take a deeper dive into supply chain requirements as per subpart G of part 117.

“As FDA continues its ‘educate while regulate’ strategy, having FDA officials present to inform attendees of the agency’s latest activities, available resources for industry, and how industry can work together with FDA in achieving compliance provides a crucial benefit,” said Rick Biros, president of Innovative Publishing Co., Inc. and director of the Food Safety Supply Chain Conference. “Andrew and Priya added tremendous insights to the conference last year, and I am thrilled to welcome them back, along with the addition of Lisa this year.”

The Food Safety Supply Chain conference takes place May 29–30 in Rockville, MD. Registration is open with a virtual attendee option as well.

Rick Biros, Priya Rathnam, and Andrew Seaborn, 2018 Food Safety Supply Chain Conference
Priya Rathnam (middle) pictured with Rick Biros, president of Innovative Publishing (left) and Andrew J. Seaborn,Supervisory Consumer Safety Officer, Division of Import Operations, ORA, FDA at the 2018 Food Safety Supply Chain Conference

About Food Safety Tech

Food Safety Tech publishes news, technology, trends, regulations, and expert opinions on food safety, food quality, food business and food sustainability. We also offer educational, career advancement and networking opportunities to the global food industry. This information exchange is facilitated through ePublishing, digital and live events.

About the Food Safety Supply Chain Conference

A food company’s supply chain can be the weakest link in their food safety program. Food ingredient adulteration, fraud, and counterfeiting negatively impacts everyone in the food supply chain. FDA has recognized the risk in the food supply chain. Sanitary transportation and the Foreign Supplier Verification Program (FSVP) are major components of FSMA. The Food Safety Supply Chain Conference addresses best practices, and new tools and technologies that can help food companies, including manufacturers, retailers and food service companies protect their brands and customers from food safety threats in their supply chain while being compliant with regulators.

FDA

FDA Announces Enforcement Discretion Related to Produce Safety Rule

By Food Safety Tech Staff
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FDA

FDA has announced it will exercise enforcement discretion for Produce Safety Rule requirements that apply to entities that grow, harvest, pack and hold wine grapes, hops, pulse crops and almonds. The agency added that it will “consider pursuing rulemaking to address the unique circumstances” that the above-mentioned products present. It also issued the guidance document, “Enforcement Policy for Entities Growing, Harvesting, Packing, or Holding Hops, Wine Grapes, Pulse Crops, and Almonds”.

magnifying glass

FDA, USDA Formally Agree to Regulate Human Food Made from Cells of Livestock and Poultry

By Food Safety Tech Staff
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magnifying glass

Today FSIS and FDA announced a formal agreement regarding the regulatory oversight of human food products derived from the cell lines of livestock and poultry. The agencies will jointly oversee regulation of these cell-cultured products to ensure both safe production as well as accurate labeling.

The agreement involves a joint regulatory framework in which the FDA will manage cell collection, cell banks, and cell growth and differentiation. During the cell harvest stage, FDA will transition oversight to FSIS and from there, FSIS will oversee production and labeling of the human food products that are derived from the cells of livestock and poultry.

“We recognize that our stakeholders want clarity on how we will move forward with a regulatory regime to ensure the safety and proper labeling of these cell-cultured human food products while continuing to encourage innovation,” said FDA Deputy Commissioner for Food Policy and Response Frank Yiannas in a USDA press release.

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FDA Report on E. Coli Outbreak in Romaine Lettuce Points to “Significant” Finding of Strain in Sediment of Water Reservoir

By Maria Fontanazza
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The November 2018 outbreak of E.coli O157:H7 infections linked to romaine lettuce caused 62 illnesses across 16 states. The FDA zeroed in on the Central Coast growing regions of northern and Central California as being responsible for the contamination. The outbreak was declared over on January 9 and yesterday FDA released the report, “Factors Potentially Contributing to the Contamination of Romaine Lettuce Implicated in the Fall 2018 Multi-State Outbreak of E.Coli O157:H7”, which provides an overview of the investigation.

The report states that a sediment sample coming from an on-farm water reservoir in Santa Maria (Santa Barbara County, California) tested positive for the outbreak strain of E. coli O157:H7. Although this particular farm was identified in several legs of the Fall 2018 traceback investigations that occurred in the United States and Canada, as well as being a possible supplier of romaine lettuce in the 2017 traceback investigations, the FDA said that the farm is not the single source of the outbreak, as there is “insufficient evidence”. The traceback suggests that the contaminated lettuce could have come from several farms, because not all tracebacks led to the farm on which the contaminated sediment was found.

“The finding of the outbreak strain in the sediment of the water reservoir is significant, as studies have shown that generic E. coli can survive in sediments much longer than in the overlying water. It’s possible that the outbreak strain may have been present in the on-farm water reservoir for some months or even years before the investigation team collected the positive sample. It is also possible that the outbreak strain may have been repeatedly introduced into the reservoir from an unknown source,” stated FDA Commissioner Scott Gottlieb, M.D. and Deputy Commissioner Frank Yiannas in a press announcement.

(left to right) Stic Harris, FDA; Matt Wise, CDC; Dan Sutton, Pismo Oceano Vegetable Exchange; Scott Horsfall, California Leafy Greens Marketing Agreement discuss the first E.coli outbreak involving romaine lettuce during a panel at the 2018 Food Safety Consortium. Read the article about the discussion.

Although the exact route of contamination cannot be confirmed, the FDA hypothesizes that it could have occurred through the use of agricultural water from an open reservoir, which has increased potential for contamination.

The investigation teams also found evidence of “extensive” wild animal activity and animal burrows near the contaminated reservoir, as well as adjacent land use for animal grazing, all of which could have contributed to the contamination.

Although FDA did not directly name the farm in the report, it provided a link about the recall that was initiated by the farm, Adam Bros. Farming, Inc., in December.

Considering the significant effect that the past two E.coli outbreaks involving romaine lettuce have had on both the public as well as the produce industry, FDA made several recommendations on preventive measures that leafy greens growers and industry can take to avoid such pathogenic contamination, including:

For growers:

  • Assessing growing operations to ensure they are in line with compliance to FSMA and good agricultural practices
  • Making sure that any agricultural water that comes into direct contact with the harvestable portion of the crop, food contact surfaces and harvest equipment is safe and sanitary
  • Address and mitigate risks associated with agricultural water contamination that can occur as a result of intrusion by wild animals
  • Address and mitigate risks associated with the use of land near or adjacent to agricultural water sources that can lead to contamination
  • Conduct root cause analysis whenever a foodborne pathogen is identified in the growing environment, agricultural inputs like water or soil, raw agricultural commodities, or “fresh-cut” ready-to-eat produce

For the broader industry:

  • The development of real-time procedures that enable rapid examination of the potential scope, source and route of contamination
  • All leafy green products should have the ability to be traced back to the source in real time, and information include harvest date. In November, FDA requested voluntary labeling [https://foodsafetytech.com/news_article/cdc-alert-do-not-eat-romaine-lettuce-throw-it-out/] to help consumers identify products affected during an outbreak
  • The adoption of best practices in supply chain traceability

Resources

  1. FDA report: “Factors Potentially Contributing to the Contamination of Romaine Lettuce Implicated in the Fall 2018 Multi-State Outbreak of E.Coli O157:H7”
  2. FDA statement from Commissioner Scott Gottlieb, M.D. and Deputy Commissioner Frank Yiannas
  3.  FDA investigation of source of E.coli O157:H7 outbreak linked to romaine lettuce
FDA

FDA Final Guidance Informs Companies on When to Notify Public about Food Recalls

By Food Safety Tech Staff
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FDA

FDA has issued a final guidance that reviews the situations in which a company should warn the public about a voluntary food recall. This includes the appropriate timeframe for issuing the warning and what information a company should include in the warning. The guidance, “Public Warning and Notification of Recalls”, also discusses when the FDA may decide to take action to issue a public warning, should one that a company issues is not sufficient.

In an agency statement, FDA Commissioner Scott Gottlieb, MD., also addresses the buzz around folks feeling that there have been more recalls. “In actuality, for fiscal year 2018, there were a total of 7,420 recalls with 831 that were classified as the highest risk. That figure represents a five-year low in recalls. However, the reason why recall notices might seem to have increased is that our publicizing of these events has become more prominent,” said Gottlieb. “We’re routinely providing more information on recalls and other safety issues that have happened.” He added that the ability to detect, track and trace product issues has improved with the help of technology, including whole genome sequencing.

“Our labs are currently testing cutting-edge technology that can screen for multiple allergens simultaneously and even technology that shrinks the genetic testing of pathogens from machines that were once the size of an entire room to a device that’s smaller than many smart phones. We’ll also be working to improve product traceability by tapping into modern approaches, such as blockchain technology, to further advance our mission of protecting public health.” – Scott Gottlieb, M.D., FDA

In addition, the agency is looking at how new technologies can be used notify consumers about whether a product they purchased has been recalled.

Frank Yiannas, FDA, food safety

Frank Yiannas, FDA’s Deputy Commissioner for Food Policy and Response, to Speak at the 2019 Food Safety Consortium Conference & Expo

By Food Safety Tech Staff
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Frank Yiannas, FDA, food safety

EDGARTOWN, MA, Feb. 8, 2019 – Innovative Publishing Co., publisher of Food Safety Tech, has announced that Frank Yiannas, deputy commissioner for food policy and response at FDA, will serve as the keynote speaker to kick off the 2019 Food Safety Consortium Conference & Expo on October 1. The Consortium is the industry’s leading food safety event for networking and educational opportunities, and takes place October 1–3 in Schaumburg, IL (just outside Chicago).

What’s all the buzz about food safety culture? Watch the videoYiannas recently took the reins in FDA’s lead food safety role following the retirement of Stephen Ostroff, M.D. He was previously the vice president of food safety at Walmart and has been a strong proponent of elevating food safety standards within organizations and implementing a food safety culture.

This year’s Food Safety Consortium Conference & Expo features three breakout tracks: Cleaning & Sanitation, Food Safety Testing, and Food Safety Management. The call for abstracts is open until May 16.

About Food Safety Tech

Food Safety Tech publishes news, technology, trends, regulations, and expert opinions on food safety, food quality, food business and food sustainability. We also offer educational, career advancement and networking opportunities to the global food industry. This information exchange is facilitated through ePublishing, digital and live events.

About the Food Safety Consortium Conference and Expo

The Food Safety Consortium Conference and Expo is a premier educational and networking event for food safety solutions. Attracting the most influential minds in food safety, the Consortium enables attendees to engage conversations that are critical for advancing careers and organizations alike. Visit with exhibitors to learn about cutting edge solutions, explore diverse educational tracks for learning valuable industry trends, and network with industry executives to find solutions to improve quality, efficiency and cost effectiveness in an ever-changing, global food safety market. This year’s event takes place October 1–3 in Schaumburg, IL.

Food Safety Tech, Food Safety Consortium Conference & Expo Announce Partnership with Alliance for Advanced Sanitation

Lettuce

CDC Reports Romaine Lettuce Outbreak Over

By Food Safety Tech Staff
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Lettuce

Although FDA is continuing its investigation into the source of the E.coli outbreak involving romaine lettuce grown in California, the CDC has declared the outbreak over. Contaminated romaine that caused illnesses should no longer be available, FDA stated in an outbreak update. Consumers will not need to avoid romaine lettuce, and retailers and restaurants do not need to avoid selling or serving the product, according to the agency. Suppliers and distributors need not avoid shipping or selling any romaine that is on the market either.

FDA has recommended that romaine lettuce is labeled with the harvest location and date, as well as whether it has been grown hydroponically or in a greenhouse. “ In case of future product withdrawals or recalls of romaine lettuce, this will help to limit the amount of product to be removed from the market and it will help consumers, restaurants and retailers determine that the romaine lettuce they are buying is from an unaffected growing region,” stated FDA. In addition, the detailed labeling should be available in stores, the agency states.

Alert

How the Government Shutdown Affects Food Safety

By Food Safety Tech Staff
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Alert

–UPDATE —January 9, 2019 – Today FDA Commissioner Scott Gottlieb, M.D. gave an update about food inspections in the context of the government shutdown. He chose Twitter to deliver his statement. He said FDA is expanding the scope of food safety surveillance inspections that are occurring during the shutdown to ensure that high-risk food facilities are address (31% of domestic inspections are high risk). He added that the agency continues to conduct all foreign food inspections.

“We assess risk based on an overall, cross-cutting risk profile. The primary factors contributing to a facility’s risk profile include: the type of food, the manufacturing process, and the compliance history of the facility. Commodities deemed high risk include, but aren’t limited to: modified atmosphere packaged products; acidified and low acid canned foods; seafood; custard filled bakery products; dairy products including soft, semi-soft, soft ripened cheese and cheese products, unpasteurized juices; sprouts ready-to-eat; fresh fruits and vegetables and processed fruits and vegetables; spices; shell eggs; sandwiches; prepared salads; infant formula; and medical foods.” – Scott Gottlieb, M.D., FDA

–END UPDATE–

As the third-longest government shutdown in U.S. history continues, businesses across industries are concerned about what resources are available.

At FDA, “All our work is important, but only some of our work is permitted to continue during a lapse in funding,” according to an agency statement. This work includes any activities that are considered “mission critical”:

  • Maintaining core functions that handle and respond to foodborne illness outbreaks
  • High-risk food recalls
  • Screening foods imported into the United States
  • The pursuit of civil and/or criminal investigations when the agency believes that the public health is at risk

At USDA, FSIS will continue much of its food safety activities Field inspection of meat, poultry and egg products will continue, as well as regulatory enforcement and product testing in labs. The agency will also continue its enforcement and food safety surveillance and investigations, which includes recall initiation, traceback/traceforward investigations.

“The agency must ensure adequate senior level management and coordination of the agency’s public health responsibilities during a shutdown. Excepted activities include responding to intentional and unintentional food safety events. A small number of individuals will support these activities for the duration of the shutdown, while others will be available on call if such an event occurs, including recall staff, scientists; recall communication specialists, significant incident specialists.” – USDA

In addition USDA/FSIS personnel at the agency’s three field labs are considered “excepted” during the shutdown. A full breakdown of FSIS activities that will continue are available on the USDA’s website.

Palmer Orlandi talks about role of labs & FSMA

Former FDA Food Safety Scientist Palmer Orlandi Joins AOAC as Chief Science Officer

By Food Safety Tech Staff
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Palmer Orlandi talks about role of labs & FSMA

Today AOAC International announced its appointment of Palmer Orlandi, Jr., Ph.D. to deputy executive director and chief science officer of the organization. Orlandi is Rear Admiral and U.S. Assistant Surgeon General, and formerly the senior science officer and research director at FDA’s Office of Foods and Veterinary Medicine. He is also and on Food Safety Tech’s Editorial Advisory Board.

“We are eager to work with Dr. Orlandi to help drive the development and execution of our science strategy to capitalize on the opportunities in front of us,” said AOAC Executive Director David B. Schmidt in a press release. “He will strengthen our ability to solve public health dilemmas and make an impact in the analytical communities. With Palmer’s impressive background and extensive knowledge in global food safety, we are confident that he will help lead and advance AOAC’s mission further as we enter our next chapter.”

Palmer Orlandi promoted
Palmer Orlandi, Jr. Ph.D., during his promotion to Rear Admiral and Assistant Surgeon General in 2017.

Orlandi’s appointment is effective next Monday, December 17. His responsibilities will include overseeing the AOAC Research Institute, standards development and proficiency testing. He will also engage in business development and strategic partnerships to advance voluntary consensus standards and international relations.

Palmer Orlandi, FDA, Food Safety Consortium
Palmer Orlandi discusses FSMA and laying the groundwork for data acceptance in lab partnerships at the Food Safety Consortium. WATCH NOW

Orlandi has 20 years of experience at FDA, with his work beginning at a research lab at CFSAN. There he developed rapid and molecular detection methods for Cyclospora and Cryptosporidia and the Microsporidia (emerging food-and waterborne protozoan parasites). In 2008 he became the science coordinator in the Division of Field Science in FDA’s ORA where he oversaw collaborative analytical methods programs for ORA and the Food Emergency Response Network. In 2012 he took on the role of senior science advisor to the chief scientist officer at the Office of Food and Veterinary Medicine. He played an active role in integrating science and research efforts across the agency’s foods program, and working to align research and lab programs to regulatory field lab needs. He earned the rank of Rear Admiral and Assistant Surgeon General in 2017.