Tag Archives: FSMA

Sprouts

FDA’s Draft Guidance Aims to Help Keep Sprouts Contamination Free

By Food Safety Tech Staff
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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Today FDA issued a draft guidance to assist sprout operators in complying with the FSMA Produce Rule, which requires “covered sprout operations take measures to prevent the introduction of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The draft guidance, Compliance with and Recommendations for Implementation of the Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption for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.

FSMA, One Year Later: Top 5 Things We’ve Learned

By Erika Miller
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Now that the first of the FSMA compliance dates have passed, let’s look back at the past year of training new PCQIs, their questions and concerns from classes as well as the perspective from our FDA friends (yes, really!) who attended our workshops. We have learned so much, it is hard to narrow it down to only five things—but if we look at the issues that arose, the following five proved to be recurring themes throughout 2016.

5. Don’t Scrap Your Current Plan

Many clients have approached us and said they were planning to throw their current food safety and/or HACCP plan in the trash and start from scratch. Please don’t do this! Companies that care about quality and food safety already have effective quality management systems in place. It would be a disservice to the company and the general public for all these time-tested plans to go straight into the bin. It is more realistic to take a look at the current system in light of the new regulation and ask yourself if there are any gaps that can be addressed. This brings us to the next point.

4. Education Is Key

A compliant system cannot be developed without an understanding of the requirements. Although FSMA is derived from the basic principles of HACCP, there are key differences, and not all of them in the direction of less regulation. It is important to understand not only the updated Good Manufacturing Practices and Preventive Controls for both Human and Animal food, but also the Foreign Supplier Verification Program, Sanitary Transportation and the Produce Rule (if they apply). Although the FDA-recognized curriculum for some of these companion regulations have not yet been released, some independent training providers are offering workshops to help fill the gap while the FDA and FSPCA are working on the official curriculum. (Comment on this article for more information via email).

3. “You Must Evaluate If You Need It” Is Not the Same as “You Don’t Need It”

Some training providers have told their attendees that they can scrap many of their current systems because FSMA is less stringent than GFSI-approved schemes. Your certification body for FSSC 22000, SQF or BRC does not care one whit how stringent FSMA is (as long as you are compliant with its requirements, as local regulatory compliance is a key factor in GFSI approval). FSMA will not change expectations related to the GFSI-approved food safety schemes. It is also misleading to think that because FSMA is flexible, FDA regulators will not have expectations of excellence when they arrive at food processing facilities. This law gives regulators the power to take legal actions to address many infractions they have seen over the years but have been powerless to stop; the flexibility may well be a double-edged sword in that regard. Ensure that all decisions are based on data and records exist to validate any claims.

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FDA

FDA Revises Draft Guidance for Listeria Control in RTE Foods

By Food Safety Tech Staff
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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

By Food Safety Tech Staff
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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.

FSC 2016

FSMA, Listeria, Fraud and Food Safety Culture Among Top Topics at Food Safety Consortium

By Maria Fontanazza
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FSC 2016

The 2016 Food Safety Consortium was a big success, from the preconference events that included the STOP Foodborne Illness fundraiser honoring heroes in food safety and the education workshops (SQF Information Day and preventive controls courses) to the record-breaking attendance we saw during the main program (with keynotes from FDA Deputy Commissioner for Foods and Veterinary Medicine Stephen Ostroff, M.D., Walmart’s Vice President of Food Safety Frank Yiannas, and FBI’s Special Agent Scott Mahloch).

As the event winded down, the leaders of each session track shared their insights on lessons learned during the Consortium.

Understanding biofilm and how it forms.  If you’re seeing peaks and valleys in the positives and negatives in your environmental swabbing program, you may have resident Listeria that has formed a biofilm, which requires a deep clean. Focus on biofilm, not just mitigation of the Listeria bacteria itself. – Gina Kramer, Savour Food Safety International. Read Gina’s column, Food Safety Think Tank, where she talks about the latest technology and innovations.

This is the first conference I’ve been to you where food fraud is being more widely acknowledged as a serious, important concern that is distinctly separate from food safety. One of the more significant takeaways is the number of tools that are now available for people to mitigate their risk to food fraud in the supply chain. – Steve Sklare, USP

Warren Hojnacki, SGS
Warren Hojnacki, SGS

A while back food safety was a nice-to-have but not a need-to-have. It’s certainly an absolute need-to-have now. There are three groups of individuals out there: The third that has picked up the baton and is proactive, the other third that are in the middle of it right now, and the other third have their heads in the sand. I come across a sizable portion that is in the bottom third, and it’s slightly scary… It’s the documentation that a lot of companies are having the biggest challenge in dealing with—the death by paper. The resources out there are immense. It’s a necessity to have right now in order to be effective and compliant.  – Warren Hojnacki, SGS

FSMA regulations require us to be risk based, scientifically based and systematic in our approach to our concerns and issues. – Barb Hunt, Savour Food Safety International

There’s potential for greater data and actions: i.e., the microbiome study or particulate contamination analysis, PLM, IR spectroscopy, SEM EDS, [and] raman spectroscopy…Lab customers may need to depend more greatly on contract labs as FSMA develops and in return, labs need to work more closely with the customers to get dependable, defensive data results. – Eric Putnam, Wixon, Inc.

Trish Wester, PA Wester Consulting
Trish Wester, PA Wester Consulting

We need to do a better job of messaging upstream to our corporate senior officials so we get the money and resources we need—there’s still a gap there. We need to find ways to communicate to them.  – Trish Wester, PA Wester Consulting

Stephen Ostroff, FDA, Food Safety Consortium

How Will FDA Gauge FSMA Success?

By Food Safety Tech Staff
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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

2017 Food Industry: 4 Trends to Watch

By Katy Jones
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From countless recalls, to FSMA deadlines, to the rising demand for transparency, 2016 has been a monumental year in the food industry. With 2017 knocking, here are the top trends and predictions to watch out for in the food industry next year.

1. Moving Toward a Fully Digital, Connected Supply Chain

The food supply chain in many ways is still lagging behind in technology compared to other supply chains. In 2017, many companies will begin or continue on their journey to fully digitize their supply chain, whether that is simply getting their list of approved suppliers out of an Excel spreadsheet and  into a supplier management software technology solution or fully capturing every step of their products along the journey from farm to fork.

The spectrum of digitization across the supply chain is quite broad. But bottom line, supply chain analytics will empower food companies to create useful KPIs, allow them to truly measure the ROI of their supply chain initiatives and give consumers the transparency that they demand. And systems that fully support the daily monitoring, sharing and interpretation of those analytics needed to help companies will experience tremendous growth in 2017.

Collaboration with your supply chain partners is an absolutely critical element, and we can expect to see more companies fully integrate throughout their network of suppliers and customers. Food companies that will succeed in 2017 will need a fully integrated supply chain network, with access to the same information, working towards a shared mission to deliver results and be ahead of their competitors. A connected supplier network will allow food companies to be agile when faced with an issue, responsive to recalls, as well as be flexible and efficient.

2. Recalls, Recalls, Recalls

We saw a high volume of recalls this year, and this trend is not going away anytime soon. As more and more advances in food testing are made, companies will have access to new technologies across their supply chain that will identify issues early. Consequently, more products will need to be pulled out of the supply chain because of that increased testing in order to maintain consumer sentiment.

The companies that are able to roll out these capabilities quickly and efficiently—armed with the data needed—will be well poised to manage their supply chain, potential recalls and the impact to their customers. With the knowledge that we can expect to see several recalls in the new year, food companies should be looking to mitigate risks and better manage their supply chain.

3. Full-force FSMA Is Here Whether You Like It or Not

FSMA focuses on amplifying preventive controls for food production in order to alleviate potential food contamination outbreaks, and the past two or more years have been focused on this preparation. This preparation will come to a pinnacle in 2017, the first full year of FSMA implementation worldwide, with the FDA starting audits for larger companies. This could lead to the FDA requesting required records, conducting audits and in the worst situation for food companies, shutting down operations if they feel it’s necessary.

FSMA will require detailed record keeping when a recall or outbreak occurs, with clearly defined corrective actions in place. Companies will see an increased need for technologies that help supply preventive processes such as food allergen and sanitation controls, as well a prepared recall and supply chain plan. Tracking and traceability will be the two key parameters that will offer manufacturers the ability to examine specific foods and trends to improve their overall process. In order to comply with these new FSMA regulations at every step of the process, food companies will increasingly look to utilize these technologies to account for full traceability of the supply chain.

4. Growth in Foodservice At the Consumer’s Doorstep

Brands like Starbucks and Panera have been testing the food home delivery waters, but more companies seem to be jumping onto the trend of bringing gourmet food directly to the consumer’s doorstep—Blue Apron, Plated, HelloFresh just to name a few.

FSMA

FDA Updates on FSMA Training

By Food Safety Tech Staff
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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?

By Food Safety Tech Staff
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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

By Food Safety Tech Staff
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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.