Tag Archives: FDA

Sprouts

FDA’s Draft Guidance Aims to Help Keep Sprouts Contamination Free

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Sprouts

Between 1996 and 2016, sprouts have been responsible to 46 outbreaks in the United States, which has led to nearly 2500 illnesses and three deaths, according to FDA. They have presented a consistent challenge to operators, because sprouts are most often produced in conditions that are ideal for bacteria growth.

Today FDA issued a draft guidance to assist sprout operators in complying with the FSMA Produce Rule, which requires “covered sprout operations take measures to prevent the introduction of dangerous microbes into seeds or beans used for sprouting, test spent sprout irrigation water (or, in some cases, in-process sprouts) for the presence of certain pathogens, test the growing, harvesting, packing and holding environment for the presence of the Listeria species or Listeria monocytogenes, and take corrective actions when needed.”

Large sprout operators must comply with the Produce Rule (applicable provisions) by January 26. Small business must comply by January 26, 2018 and very small businesses by January 28, 2019.

The draft guidance, Compliance with and Recommendations for Implementation of the Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption for Sprout Operations, is open for comment for the next 180 days.

FDA

FDA Revises Draft Guidance for Listeria Control in RTE Foods

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FDA

Any food facility that manufactures, processes, packs or holds ready-to-eat (RTE) foods should view FDA’s update on its draft guidance, Control of Listeria monocytogenes in Ready-To-Eat Foods. Consistent with FSMA, the draft focuses on prevention, and includes best practices and FSIS’s seek-and-destroy approach. Other recommendations include controls involving personnel, cleaning and maintenance of equipment, sanitation, treatments that kill Lm, and formulations that prevent Lm from growing during food storage (occurring between production and consumption).

“This guidance is not directed to processors of RTE foods that receive a listericidal control measure applied to the food in the final package, or applied to the food just prior to packaging in a system that adequately shields the product and food contact surfaces of the packaging from contamination from the food processing environment.” – FDA

The agency will begin accepting comments on January 17.

Stephen Ostroff, 2016 Food Safety Consortium

Ask the FDA: Recognizing Third Party Accreditation Bodies

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Stephen Ostroff, 2016 Food Safety Consortium

READ: The Multi-Step Process of Third-Party Accreditation Stephen Ostroff, M.D. will keynote at the 2017 Food Safety Consortium on November 29 | Learn moreDuring a Town Hall at the 2016 Food Safety Consortium, FDA Deputy Commissioner for Foods and Veterinary Medicine Stephen Ostroff, M.D. answers an attendee’s question about the agency’s guidance, Third-Party Certification Body Accreditation for Food Safety Audits: Model Accreditation Standards and what progress FDA has made in recognizing accreditation bodies.

Recall

Persistent Strain of Salmonella Triggering Dozens of Recalls

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Recall

The recalls involving powdered milk continue to pile up.

Since December, more than a dozen products containing powdered milk have been recalled due to the risk of Salmonella, including mini eclairs and cream puffs, mac & cheese products, chocolate-covered pretzels, potato chips, seasonings and white peppermint Hostess Twinkies.

Back in November, FDA seized more than 4 million pounds of dry nonfat milk powder and buttermilk powder produced by Valley Milk Products, LLC. The agency used whole genome sequencing to make the connection between the samples that were collected in the facility—Salmonella strains were found from samples taken in 2016 and back to 2010. FDA identified it as a persistent strain of the pathogen.

“FDA investigators observed residues on internal parts of the processing equipment after it had been cleaned by the company and water dripping from the ceiling onto food manufacturing equipment. In addition, environmental swabs collected during the inspection confirmed the presence of Salmonella meleagridis on surfaces food came into contact with after being pasteurized.” – FDA news release

To date, no illnesses have been reported.

Robert Califf, FDA

Will FDA Commissioner Califf Leave Under Trump Administration?

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Robert Califf, FDA

In a recent interview with The Washington Post, FDA Commissioner Robert Califf, M.D. said that President-elect Donald Trump’s transition team has not contacted him. Califf hasn’t even been head of the agency for a full year. It is rumored that if Califf leaves, Stephen Ostroff, M.D., deputy commissioner for foods and veterinary medicine, will step in (Ostroff has previously served as acting deputy commissioner of FDA). Ostroff stepped into his current role when Mike Taylor left FDA last June.

Stephen Ostroff, FDA, Food Safety Consortium In the following video, Stephen Ostroff, M.D. discusses: Are Final FSMA Rules Cast in Stone?

 

Stephen Ostroff, FDA, Food Safety Consortium

How Will FDA Gauge FSMA Success?

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Stephen Ostroff, FDA, Food Safety Consortium

Stephen Ostroff, M.D. will keynote at the 2017 Food Safety Consortium on November 29 | Learn moreHow will the FDA gauge how well the food industry understands FSMA? This question was posed to agency Deputy Commissioner for Foods and Veterinary Medicine Stephen Ostroff, M.D. at the 2016 Food Safety Consortium.

While it will be important for FDA to have measures that it can use in assessing compliance, the process will take time. Watch Ostroff’s response in the following video.

Read the article: FDA on Enforcement: Our Goal Is to Help, Not Punish

FSMA

FDA Updates on FSMA Training

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FSMA

Today FDA updated its FSMA training strategy to reflect the progress made during 2016. The program, which targets farmers, small food processors and small produce merchant wholesalers, includes the following updates:

  • Cooperative agreement for small and mid-size businesses involved in local food production awarded to the National Farmers Union Foundation
  • Cooperative agreement for preparing food producers in Native American tribes awarded to the University of Arkansas in Fayetteville
  • Federal grants awarded for establishing regional centers to facilitate training under FDA’s partnership with USA’s National Institute of Food and Agriculture
FSC 2016, Ostroff and Almanza

Are Final FSMA Rules Cast in Stone?

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FSC 2016, Ostroff and Almanza

Stephen Ostroff, M.D. will keynote at the 2017 Food Safety Consortium on November 29 | Learn moreEarlier this month Stephen Ostroff, M.D., deputy commissioner for foods and veterinary medicine at FDA, told attendees at the 2016 Food Safety Consortium about the agency’s commitment to a proactive food safety system. He also discussed FDA’s stance on criminal liability and took questions from the audience, one of which was:  Now that the FSMA rules are final, are they cast in stone? Does FDA have any flexibility in making changes. Listen to Ostroff’s answer in the following video.

 

FDA

FDA Issues Final Rule on FSMA Third-Party Certification User Fee Program

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FDA

This week FDA issued a final rule that provides for a user fee program to evaluate fees and require reimbursement for work that FDA performs to establish and administer the third-party certification program. The rule, “Amendments to Accreditation of Third-Party Certification Bodies To Conduct Food Safety Audits and To Issue Certifications To Provide for the User Fee Program”, is effective January 13, 2017.

FDA also announced its fiscal year 2017 fee rate for accreditation bodies that are applying to be recognized by the third-party certification program. The fee will remain in effect through September 30, 2017.

Stephen Ostroff, 2016 Food Safety Consortium

FDA’s Take on Criminal Liability

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Stephen Ostroff, 2016 Food Safety Consortium

Stephen Ostroff, M.D. will keynote at the 2017 Food Safety Consortium | Learn moreCriminal liability has been a hot topic in food safety over the past year. During the 2016 Food Safety Consortium, FDA Deputy Commissioner for Foods and Veterinary Medicine Stephen Ostroff, M.D., clarified FDA’s stance on enforcement.

“Our goal is for us to promote food safety, not to resort first and foremost to enforcement actions,” said Ostroff.

For Ostroff’s full comment, watch the video.