Tag Archives: FDA

FDA

No FDA Mandatory Recall Activity in 2015

By Food Safety Tech Staff
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FDA

On Friday FDA released its 2015 Annual Report to Congress on the Use of Mandatory Recall Authority and there was not much news to report.  According to the agency: “In FY 2015, FDA had no mandatory recall activity to report under section 423 of the FD&C Act. As a result, FDA did not issue any public health advisories as described in section 206(f) of FSMA.”

This is the third report of its kind since FSMA was enacted. It is worthy to not that it only deals with recalls themselves, not other agency communication efforts such as public health advisories, which include consumer advisories, warning letters and reports of outbreak investigations.

Robert Califf, FDA

Senate Confirms Califf to Head FDA

By Food Safety Tech Staff
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Robert Califf, FDA

In an 89-4 vote by the U.S. Senate, Robert Califf, M.D., was confirmed as the next commissioner of FDA last week. The accomplished cardiologist and researcher will take on the task of implementing FSMA, along with responsibilities in overseeing medical device and pharmaceutical regulations, and tobacco products.

“I commend the Senate for their bipartisan vote today and am pleased that President Obama’s nominee, Dr. Robert Califf, will become the commissioner of the Food and Drug Administration, said Sylvia M. Burwell, HHS secretary, in a statement. “I look forward to working with Dr. Califf to ensure the FDA can carry out every aspect of its critical mission; from ensuring the safety and effectiveness of the medical products we use, to protecting the nation’s food supply and implementing its oversight of tobacco products, to furthering our efforts to combat opioid abuse.”

FDA

Part of FDA FY 2017 Budget Request to Hold Food Importers Accountable

By Food Safety Tech Staff
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UPDATE 2/22/2016 – According to an updated FDA alert, the FY2017 budget requests include an increase of $25.3 million of new budget authority to implement FSMA, with FDA focusing on two main areas:

  • National Integrated Food Safety System  ($11.3 million). Support state capacity to implement the produce safety rule via education and technical assistance to farmers and on‑going compliance support and oversight
  • New Import Safety Systems ($14.0 million). Implementing the FSVP rule, which makes importers responsible for ensuring that the foods they bring in from other countries are produced in a manner that is consistent with U.S. food safety standards

– END UPDATE –

FDA wants 8% more money for its FY 2017 budget, requesting a total of $5.1 billion.  Part of this $14.6 million net increase in budget authority will go toward FSMA implementation. Specifically related to food safety, FDA is asking for more than $18.4 million in budget authority and more than $193.2 million in user fees. According to an FDA press release, the agency will be using the budget to support federal and state efforts related to enforcing safety standards on produce farms. In addition, FDA wants to use the money “to hold importers accountable for verifying that imported food meets U.S. safety standards, as well as conduct food safety audits of foreign food facilities”.

FDA is also requesting more than $3 million for building and facilities funding, and more than $600,000 to support other areas to improve the agency’s infrastructure. The fiscal request is for October 1, 2016 through September 30, 2017.

Dollar

FDA Makes FSMA Education and Training Available

By Food Safety Tech Staff
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As part of FDA’s FSMA training vision, the agency has announced two funding opportunities aimed at providing outreach, education and training on the FSMA preventive controls rules.

The Native American Tribes Outreach, Education and Training cooperative agreement will provide up to $750,000 annually for three years. “FDA anticipates that federally recognized tribes will need food safety education and training that addresses the regulatory requirements of the applicable FSMA rules and also encompasses specific cultural practices associated with produce farming and food manufacturing/processing within tribes relevant to their status as sovereign nations,” according to an FDA release.

The Local Food Producer Outreach, Education, and Training agreement will award local food producers $1.5 million this fiscal year with the potential for two more years if federal funds are available. It aims to assist small and mid-size producers/processors with particular practices related to their scale of production and management practices. The agreement will focus on those involved in local food systems while considering “account diversified, sustainable, organic and identity-preserved agricultural production and processing.”

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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.