Tag Archives: FDA

Stephen Ostroff, FDA

FDA’s Stephen Ostroff Sounds Off on FSMA: Miles to Go

By Food Safety Tech Staff
No Comments
Stephen Ostroff, FDA

With less than a week under his belt as the new Deputy Commissioner for Foods and Veterinary Medicine, Stephen Ostroff, M.D., has made one of his first official statements about food safety. Calling the FSMA final rules a paradigm shift in prevention versus response, he emphasized the importance of the implementation stage on FDA Voice, the agency’s blog.

“The people of FDA, under the leadership of Michael R. Taylor, worked tirelessly to find the right intersection between science and policy; to develop innovative and practical solutions to complex challenges; and, to engage in open and meaningful discussions with the many communities within the diverse food supply system,” said Ostroff in the blog.

Although industry has “miles to go” during implementation, Ostroff emphasized the behind-the-scenes work that made FSMA happen—thanking specific members of Congress, consumer activists such as STOP Foodborne Illness, public policy organizations, national associations such as the Grocery Manufacturers Association, government organizations and global regulatory counterparts.

Guess What? Canada’s Food Safety System Comparable to United States

By Food Safety Tech Staff
1 Comment

Yesterday the FDA, Canadian Food Inspection Agency (CFIA) and the Department of Health Canada signed an agreement that recognizes their food safety systems as comparable. Signed at an FDA-CFIA Health Canada Joint Committee on Food Safety meeting, the agreement will allow the agencies to leverage their regulatory systems and partner on various activities such as oversight when prioritizing inspections, scientific collaboration, and outbreak response.

“This arrangement is part of the US-Canada Regulatory Cooperation Council in which the countries intend to better align their food safety regulatory systems, reduce unnecessary duplication, enhance information sharing, and to the extent possible, leverage resources so that the agencies can better meet their public health objectives,” said Michael Taylor, deputy commissioner for foods and veterinary medicine at FDA in a statement.

According to an FDA release: “Systems recognition involves reviewing a foreign country’s domestic food safety regulatory system to determine if it has legal authorities and regulatory tools that together provide public health outcomes comparable to those provided by the FDA. Domestic systems provide the baseline level of public health protection that helps assure the safety of exported foods from that country. Systems recognition will help the FDA be more risk-based in planning the scope and frequency of its inspection activities, including foreign facility inspections, import field exams, and import sampling.”

The agencies used the International Comparability Assessment Tool to conduct a systems recognition review and assessment involving elements of Canada’s national food safety control system. This included examining laws and regulations, inspection programs, response to outbreaks, and other compliance, enforcement and lab support activities.

Text of the agreement between the agencies is available on FDA’s website.

magnifying glass

How to Survive an FDA Foreign Facility Inspection

By Maria Fontanazza
No Comments
magnifying glass

Since 2002, the amount of FDA-regulated food imported to the United States has nearly doubled. With the implementation of FSMA well underway, expect that FDA will be increasing its inspections at foreign manufacturing facilities. When prioritizing inspections, FDA looks at a facility’s compliance history, the risk of the product manufactured in the plant, the date of its last inspection, and any import alerts associated with the site.

First and foremost, it’s important to make sure your foreign facility understands what a food safety plan under FSMA requires, said Chengboey Lau, principal scientist for North America scientific & regulatory affairs at Mondelēz International.  Today at the GMA Science Forum Lau pulled from the experience of Mondelez (the $30 billion-company has more than 165 manufacturing plants worldwide and requires all of its suppliers to be GFSI certified) to provide some helpful tips on how a company can get ready for an FDA inspection of a foreign facility, what it should do during the event, and the steps that should be taken afterwards.

Prepare for the Inspection

  • Develop an internal policy for foreign inspections
  • To ensure readiness at all times, implement a proactive program that involves the following activities
    • Annual review of registered facilities
    • Review of any products or materials made for U.S. markets (including R&D samples)
    • Gap assessments to ensure compliance with FDA requirements, followed by an action plan to close identified gaps
    • Employee training on FDA requirements
    • Create a site-specific FDA inspection manual for all necessary documentation

Survive the Inspection

  • Align expectations with the inspector at the start of the inspection
  • Have an employee who has strong English skills present to help with translation (the employee should have an understanding of American slang, too)
  • Consider having a U.S. regulatory support colleague available for questions during the inspection

Post-inspection

  • Email the inspector or make a Freedom of Information Act request if you don’t receive an establishment inspection report after six months
  • If a form 483 letter is issued, respond in writing within 15 days, and follow up within 40 days to inform FDA of the completion of any corrective actions

At the end of the day, make sure you have a firm understanding of which final FSMA rules apply to your organization, advised Lau. From there companies should perform a gap analysis, identify the resources necessary and any constraints involved, train employees on the new FSMA expectations, and be prepared to implement new and/or modify current policies and procedures to ensure inspection readiness.

Department of Justice seal

Watch Out, DOJ and FDA Prioritizing Prosecution

By Food Safety Tech Staff
No Comments
Department of Justice seal

In remarks made at the Consumer Federation of America’s annual food policy conference this week, Benjamin C. Mizer, principal deputy assistant attorney general, stated that the federal government has made consumer safety a top priority. With this announcement comes an announced intention on the part of the U.S. Department of Justice (DOJ) to use “various enforcement tools that we have at our disposal,” and maintain a stronger partnership with FDA to go after companies that “introduce adulterated foods into interstate commerce”.

“In deciding whether to use our civil or our criminal enforcement tools, the Justice Department follows the same set of guidelines that apply to every criminal prosecution,” said Mizer. “Among other things, prosecutors evaluate the nature and seriousness of the offense, the deterrent effect of the prosecution and the culpability of the individuals or entities involved.” Criminal charges brought against a food company can be either misdemeanor or felony, and Mizer emphasized that misdemeanor violations can still result in “serious penalties”. He cited a case in which the owner and CEO of an egg production company in Iowa pled guilty to a misdemeanor and received three months in jail and one year supervised release, and was slapped with a $100,000 fine.

“In some cases, the facts are so egregious that it is appropriate for the Justice Department to bring the full force of the law to bear,” stated Mizer. “When we can show an intent to defraud or to mislead consumers or the FDA, a defendant can face felony charges.” To illustrate this scenario, Mizer referred to the landmark case against the Peanut Corporation of America, which is perhaps the most commonly referenced case in recent months, as many in the industry have voiced their opinion that it has set a precedent as to how the government will handle such situations moving forward.

Federal Government Takes Regulatory and Criminal Offensive Against Food Industry

 

FSMA, Food Safety Tech, FDA

FDA Submits Sanitary Transportation Final Rule

By Food Safety Tech Staff
No Comments
FSMA, Food Safety Tech, FDA
Syed Hassan of PepsiCo addresses Michael Taylor during FDA Town Hall
How are FDA investigators taking a new approach with FSMA? WATCH THE VIDEO

FDA announced today that it has submitted the final FSMA rule, Sanitary Transportation of Human and Animal Food, to the Federal Register for publication. It can take a few days for the documents to be available, so stay tuned for updates from Food Safety Tech once the final rule is available.

In the meantime, find out how the sanitary transportation rule affects employee training: Specific Training Required Under FSMA: A Look at Each Rule

 

Palmer Orlandi, Food Labs Conference

Problem: Lab Systems for Data Don’t Talk to Each Other

By Food Safety Tech Staff
No Comments
Palmer Orlandi, Food Labs Conference

FDA has standard templates and worksheets, along with an electronic submission form that can be used to pull data related to lab testing. However, within industry not all of these electronic systems speak to each other. During an FDA Town Hall at the Food Labs Conference last week, Palmer Orlandi, Ph.D., acting chief science officer and research director at FDA’s Office of Food and Veterinary Medicine, answers an audience question about the issue and discusses the challenges associated with standardized templates that are used by various federal and state labs and the compatibility issues.

 

FDA

No FDA Mandatory Recall Activity in 2015

By Food Safety Tech Staff
No Comments
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
No Comments
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
No Comments
FDA

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
No Comments
Dollar

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.”