Tag Archives: FDA

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Pesticide Residues Not a Food Safety Risk, Says Federal Government

By Food Safety Tech Staff
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After publishing data from its 2014 Pesticide Data Program (PDP) earlier this week, the USDA has stated that it is not concerned with the level of pesticide chemical residues in the U.S. food supply. More than 99% of products sampled through the USDA’s Pesticide Data Program had residues below EPA tolerances (residues exceeding the tolerance were detected in 0.36% of samples).

“The PDP plays an essential role in ensuring the safety of the U.S. food supply. Under the Federal Food, Drug, and Cosmetic Act, the FDA has authority to take enforcement action when a food bears or contains unlawful pesticide chemical residues,” said Susan Mayne, Ph.D., director of FDA’s Center for Food Safety and Applied Nutrition in a press release. “By providing an accurate assessment of pesticide levels in the most commonly consumed commodities in America, the PDP generally confirms the U.S. food supply is safe with respect to pesticide chemical residues.”

Among the foods tested were fresh and processed fruits and vegetables, oats, rice, and salmon. The findings from the PDP annual summary can be accessed via the USDA’s website.

Maria Fontanazza, Editor-in-Chief, Innovative Publishing Co. LLC
From the Editor’s Desk

Will It All Come Tumbling Down for Chipotle?

By Maria Fontanazza
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Maria Fontanazza, Editor-in-Chief, Innovative Publishing Co. LLC

As of late, the problems for Chipotle have been endless. 2015 was a year of several Salmonella, norovirus and E. coli outbreaks for the restaurant chain. With the first full week of the new year wrapped up, 2016 is off to perhaps an even rockier start, with news of the company being hit with both a class action lawsuit and a federal grand jury subpoena.

Company stockholder Susie Ong filed a civil complaint against Chipotle on January 8, stating that the company made false or misleading statements and failed to disclose that its “quality controls were inadequate to safeguard consumer and employee health.” Filed in the U.S. District Court for the Southern District of New York, the complaint calls out a norovirus outbreak that occurred in August in Simi Valley, California; a Salmonella outbreak in Minnesota that sickened 64 people; the closure of all company restaurants in Portland, Oregon and Seattle, Washington in November following an E.coli outbreak; and the highly-publicized norovirus outbreak that sickened more than 140 students from Boston College in Brighton, Massachusetts last month.

Ong’s complaint also mentions the federal grand jury subpoena, which Chipotle made public two days prior (January 6) in an SEC filing. Served in December, the subpoena is part of a criminal investigation by FDA and the U.S. Attorney’s Office for the Central District of California into the Simi Valley norovirus outbreak, which sickened about 100 patrons and employees (some reports state that more than 200 people fell ill). Ong’s lawsuit states that health inspectors found “dirty and inoperative equipment, equipment directly linked to the sewer, and other sanitary and health violations” at the Simi Valley restaurant.

With December’s norovirus outbreak in Brighton and the CDC’s announcement that it was further investigating five new cases of E. coli that were reported the month prior, restaurant sales were down 30% for the month, according to the SEC filing. Ong adds up all of these unfortunate events in the lawsuit, stating, “As a result of defendants’ wrongful acts and omissions, and the precipitous decline in the market value of the Company’s securities, Plaintiff and other Class members have suffered significant losses and damages.”

Chipotle has not yet publicly commented on the lawsuit.

Earlier in December, Chipotle called attention to improvements it was making to its food safety program by bringing in IEH Laboratories and Consulting Group to reevaluate its processes in an effort to prevent future outbreaks. Clearly that was not enough.

Food companies take heed. 2016 is off with a bang, and not in a good way. Last week industry was also buzzing about the DOJ’s investigation into Blue Bell Creameries over the deadly Listeria outbreak. FDA and the other federal powers-that-be are making it very clear that negligence will no longer be tolerated (Or should I say, alleged negligence, in this case). Compliance, accountability, and above all, ethical behavior are at the heart of the matter.

Will it all come tumbling down for Chipotle? It remains to be seen whether the company will be able to recover from these issues. And maybe an even bigger question is, who will be next?

Stephen Ostroff, FDA

FDA Commissioner Reflects on Food Safety Progress in 2015

By Food Safety Tech Staff
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Stephen Ostroff, FDA

Stephen Ostroff, M.D., acting commissioner for food and drugs at FDA, released his final blog on 2015 FDA achievements earlier this week, highlighting the strides made in food safety. As expected, Ostroff pointed to FSMA and how it will help industry take stronger steps in preventing contamination, improving safety in growing produce and holding importers accountable. He offered a few agency high points in food safety for 2015:

FDA Town Hall, 2015 Food Safety Consortium

Working Smarter with Foreign Regulatory Bodies on Imports

By Food Safety Tech Staff
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FDA Town Hall, 2015 Food Safety Consortium

With FDA’s limited resources, it’s important for the agency to work smarter, not necessarily harder, when it comes to implementing FSMA. During an FDA Town Hall at the Food Safety Consortium last fall, Michael Taylor, deputy commissioner for foods and veterinary medicine at FDA, briefly touched on the agency’s strategy for working with foreign parties to ensure compliance related to importing foods into the United States, including the Food Safety Systems Recognition Agreement with New Zealand.

Syed Hassan of PepsiCo addresses Michael Taylor during FDA Town Hall. Photo: amyBcreative

FDA Investigators Take New Approach with FSMA

By Food Safety Tech Staff
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Syed Hassan of PepsiCo addresses Michael Taylor during FDA Town Hall. Photo: amyBcreative

One of the industry concerns related to FSMA implementation surrounds the change in approach required of FDA investigators—from a resolutions approach to a systematic method of assessing systems and facilities. During an FDA Town Hall at the Food Safety Consortium, Michael Taylor, deputy commissioner for foods and veterinary medicine at the agency explained that he was initially concerned about this shift, but is now pleased with the enthusiasm he sees among FDA investigators. “They’re part of a public health force that is out there empowered and supported in the verifying the systems… as opposed to the historic role of collecting evidence [and] going back to the office…” he said.

FDA Work Begins on FSMA Implementation

By Food Safety Tech Staff
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Part II of Michael Taylor’s speech at the Food Safety Consortium gets into what’s at stake as the implementation stage of FSMA begins. “We’re regulating areas we haven’t regulated before,” said Watch Part I of Michael Taylor’s speech HERETaylor, as he acknowledged the work FDA has been doing with produce growers and the enforceable standards that will now be present on farms. He also indicated the challenges ahead in regulating imports and managing the supply chain—more than 150 countries send food products to the United States, and this continues to grow rapidly.

“We see the import aspect of implementation perhaps being the most daunting in the sense that it’s really requiring us to work in completely new ways with foreign partners, with the import community, and a whole new robust toolkit…that needs to be used in a strategic new way,” said Taylor.

Michael Taylor reflects on FSMA journey

Metrics for FSMA Compliance a Work in Progress

By Food Safety Tech Staff
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Michael Taylor reflects on FSMA journey

Ideally, FDA wants to have the ability to use metrics for monitoring and measuring reductions in foodborne illnesses. However, this is extremely difficult right now, according to Michael Taylor, FDA deputy commissioner for foods and veterinary medicine. At the 2015 Food Safety Consortium, Taylor responds to an audience question of whether metrics for FSMA compliance have been established.

FDA Reflects on Monumental Effort of FSMA

By Food Safety Tech Staff
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Four years in the making and the FSMA implementation journey has begun. Michael Taylor, deputy commissioner for Watch Part II of Taylor’s speechfoods and veterinary medicine at FDA, describes, from a high-level perspective, what lies ahead in his first public speech since five of the seven rules were finalized. The following video is Part I of Taylor’s speech at the 2015 Food Safety Consortium conference.

Palmer Orlandi, FDA, Food Safety Consortium

FSMA and Laying Groundwork for Data Acceptance in Lab Partnerships

By Food Safety Tech Staff
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Palmer Orlandi, FDA, Food Safety Consortium

Laboratories play a key role in FSMA, including providing data and analytical support, and assistance in surveillance and outbreak activities.

According to Palmer Orlandi, Ph.D., acting chief science officer and research director at FDA, success in the laboratory to support all the activity involving FSMA hinges on the following:

  • Mutual reliance on partners (federal, state and FDA)
  • Data-sharing capabilities (how data is generated and transmitted)
  • Acceptance of lab data

Establishing uniform standards of performance surrounding data quality and sharing, and ensuring that data has been verified and can be trusted lay the groundwork for data acceptance. Orlandi discussed the process of establishing data acceptance criteria at the 2015 Food Safety Consortium conference.

FSMA: Biggest Challenge is Preparation, Outbreaks Still to Come, Says FDA

By Maria Fontanazza
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FDA's Michael Taylor called the journey to FSMA an "amazingly robust process". (Click to enlarge)
FDA’s Michael Taylor called the journey to FSMA an “amazingly robust process”. VIEW VIDEO

FSMA isn’t about zero risk but rather minimizing the hazards, said Michael Taylor, FDA’s deputy commissioner for foods and veterinary medicine at the opening of the Food Safety Consortium conference yesterday. “We have hundreds of thousands of businesses that are subjected to something that they weren’t before,” said Taylor. “The reality is, we’re still going to have outbreaks this year and the next year.”

In his first public speech since three final FSMA rules (on produce safety, foreign supplier verification, and accredited third-party certification) were filed on the Federal Register last week, Taylor shared some of the highs of the formation of the regulation as well as the challenges that are to come with implementation. “Many of us who were involved in the process 20 years ago didn’t imagine we’d get here today,” he said.

Syed Hassan of PepsiCo asks Michael Taylor how FDA will handle the shift in mindset that FSMA requires of agency investigators.
Syed Hassan of PepsiCo asks Michael Taylor how FDA will handle the shift in mindset that FSMA requires of agency investigators. (Click to enlarge)

Right now FDA is looking at the big picture challenge of preparing the agency and industry, and actually getting the work done. Taylor called the implementation challenge “enormous”, thanks to the significant scale of the food system, and said the import piece of the regulation will take the most hands on deck. The ultimate goal of FSMA is real-time prevention versus reaction, and the regulation will require a lot of change within FDA. According to Taylor, the agency is revamping its internal management processes, along with its training and orientation programs, which also includes food safety culture training. Other activities include restructuring the inspection and compliance approach by realigning its field force to have fully specialized teams of inspectors.

One of the challenges that industry sees is the mindset shift in investigators from a resolutions approach to a systematic approach in assessing systems. When asked how FDA will get investigators to this level, Taylor admitted he was a lot more worried about the issue than he is now. The district folks in the front line are enthusiastic about the new approach and feel empowered by FDA’s new mission, he said. And while he didn’t want to be a Pollyanna about the extent of the effort, FDA knows that the agency workforce will not be 100% aligned on day one of implementation and is managing the process with this awareness.

Voluntary compliance is key, and while the weight of ultimate accountability stands on the shoulders of food and beverage companies, success cannot happen without collaboration with FDA. “We are convinced we’ll get 90% of the job done by working with those who are committed to doing the right thing,” said Taylor. “When that fails, there are other ways to deal with that issue.”

Five of the seven FSMA rules have been finalized. Michael Taylor and Rick Biros, publisher of Food Safety Tech and conference director of the Food Safety Consortium take a selfie to capture the "Kodak" moment.
Five of the seven FSMA rules have been finalized. Michael Taylor and Rick Biros, publisher of Food Safety Tech and conference director of the Food Safety Consortium, take a selfie to capture the “Kodak” moment.

All images by amyBcreative photography.