Tag Archives: compliance

FDA

FDA Says Routine Intentional Adulteration Inspections Will Start March 2020

By Food Safety Tech Staff
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FDA

Learn more about how to mitigate the risks of food fraud and intentional adulteration at the Food Safety Supply Chain Conference | May 29–30, 2019 | Rockville, MD or attend virtuallyThis week FDA made an announcement during a public meeting that the agency’s routine inspection to verify compliance with the FSMA Intentional Adulteration rule will start next March.

The first compliance date for the rule is this July. It is a requirement for food facilities covered under this rule to develop and implement a food defense plan that identifies vulnerabilities and the consequent mitigation plan.

FDA stated that it has received feedback on the “novel nature” of the rule’s requirements and that stakeholders want more time to develop their food defense plans. “ To allow industry time with the forthcoming materials, tools, and trainings, and because the IA rule represents new regulatory territory for all of us, we will be starting routine IA rule inspections in March 2020,” FDA stated and added that it is working on developing more resources as well as the final part of draft guidance to continue to assist industry.

2019 Food Safety Supply Chain Conference

FDA to Provide FSMA Update at 2019 Food Safety Supply Chain Conference

By Food Safety Tech Staff
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2019 Food Safety Supply Chain Conference

EDGARTOWN, MA, April 8, 2019 – Innovative Publishing Co., publisher of Food Safety Tech, has announced three speakers from FDA will kick off the 5th Annual Food Safety Supply Chain Conference on May 29–30. Priya Rathnam, Supervisory Consumer Safety Officer, CFSAN; Andrew J. Seaborn, Supervisory Consumer Safety Officer, Division of Import Operations, ORA; and Lisa L. Ross, Consumer Safety Officer, CFSAN (Office of Food Safety, Multi-Commodity Foods, Refrigerated and Frozen Foods Team) will provide the opening presentations on Wednesday, May 29. An interactive Town Hall with attendees will follow.

Lisa Ross, CFSAN, FDA
Lisa L. Ross, Consumer Safety Officer, CFSAN

Seaborn, Rathnam and Ross will provide FDA perspective on FSVP inspection updates, including outcomes and compliance, the voluntary qualified importer program (VQIP) and where the agency is headed with enforcement activities. They will also take a deeper dive into supply chain requirements as per subpart G of part 117.

“As FDA continues its ‘educate while regulate’ strategy, having FDA officials present to inform attendees of the agency’s latest activities, available resources for industry, and how industry can work together with FDA in achieving compliance provides a crucial benefit,” said Rick Biros, president of Innovative Publishing Co., Inc. and director of the Food Safety Supply Chain Conference. “Andrew and Priya added tremendous insights to the conference last year, and I am thrilled to welcome them back, along with the addition of Lisa this year.”

The Food Safety Supply Chain conference takes place May 29–30 in Rockville, MD. Registration is open with a virtual attendee option as well.

Rick Biros, Priya Rathnam, and Andrew Seaborn, 2018 Food Safety Supply Chain Conference
Priya Rathnam (middle) pictured with Rick Biros, president of Innovative Publishing (left) and Andrew J. Seaborn,Supervisory Consumer Safety Officer, Division of Import Operations, ORA, FDA at the 2018 Food Safety Supply Chain Conference

About Food Safety Tech

Food Safety Tech publishes news, technology, trends, regulations, and expert opinions on food safety, food quality, food business and food sustainability. We also offer educational, career advancement and networking opportunities to the global food industry. This information exchange is facilitated through ePublishing, digital and live events.

About the Food Safety Supply Chain Conference

A food company’s supply chain can be the weakest link in their food safety program. Food ingredient adulteration, fraud, and counterfeiting negatively impacts everyone in the food supply chain. FDA has recognized the risk in the food supply chain. Sanitary transportation and the Foreign Supplier Verification Program (FSVP) are major components of FSMA. The Food Safety Supply Chain Conference addresses best practices, and new tools and technologies that can help food companies, including manufacturers, retailers and food service companies protect their brands and customers from food safety threats in their supply chain while being compliant with regulators.

FDA

Routine Produce Inspections to Start in Spring, FDA Offering Compliance Support

By Food Safety Tech Staff
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FDA

After FDA delayed product inspections under FSMA to further prepare industry and ensure there was enough training and education, the agency is reminding farmers and other stakeholders in the produce industry that there are resources available to help them in preparing for the routine inspections—for large farms, these will start in the spring. The inspections will be conducted to verify compliance with the Produce Safety rule.

Resources include the FDA’s produce safety inspections page on its website to serve as a central resource for industry and state partners during the inspection preparation process and the draft guidance, “Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption”.

An FDA Voices blog by FDA Commissioner Scott Gottlieb, M.D., Deputy Commissioner for Food Policy and Response Frank Yiannas and Associate Commissioner of Regulatory Affairs Melinda Plaisier also discussed how the agency has been supporting industry work to comply with the rule, including:

  • Granting 46 states and one territory with more than $85 million through the State Produce Implementation Cooperative Agreement Program to aid in the development of state produce safety systems that offer education, outreach and technical assistance
  • With partners, supporting the training of more than 31,000 produce farmers globally on the Produce Safety rule requirements
  • The sharing of expertise via the FDA’s Produce Safety Network
  • With partners, the creation of a new inspection form that gives farms feedback and observations that occurred during the inspection, regardless of whether non-compliance issues were found, in an effort to help explain what they’re looking at and how observations apply to the produce rule
Food Safety Tech

Call for Abstracts: Be a Part of the 2019 Food Safety Supply Chain Conference

By Food Safety Tech Staff
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Food Safety Tech

The supply chain is a potentially weak and vulnerable part of a company’s food safety plan. The annual Food Safety Supply Chain Conference is months away and we are accepting abstracts for presentations. The conference takes place May 29–30, 2019 in Rockville, MD.

If you have expertise in the following areas, we invite you to submit an abstract to present at the conference:

  • Food Safety Supply Chain Vulnerabilities & Solutions
  • Audits & Inspections
  • How to Write Supplier Specifications
  • Blockchain Technology
  • FSMA’s Sanitary Transportation Compliance Tools & Techniques
  • Supply Chain Traceability
  • FSMA’s FSVP Compliance Tools & Best Practices
  • Data, Predictive Analysis
  • Recalls: barcode labeling, case histories and lessons learned
  • Testing Strategies of the Supply Chain
  • Supplier Verification Best Practices
  • Supply Chain Risk Management
  • Food Safety Transportation, Distribution and Logistics
  • Food Authenticity
  • Food Safety/Quality Culture measurement in supplier management
  • Supplier Management Case Histories

Each abstract will be judged based on educational merit. The submission deadline is February 8, 2019.

Rizepoint Exhibiting at #2018FSC: A Better Supplier Quality Management Solution

RizePoint, a leading provider of brand, quality, and safety management software (QMS), will be exhibiting at Food Safety Consortium (FSC) in Chicago from November 13–15, 2018.

FSC is the first event where the company is demonstrating the new functionality for frictionless supplier onboarding and upgraded supplier quality management (SQM). This product enhancement helps managers in any industry onboard, track, and communicate with suppliers and vendors to help ensure regulatory and company standards compliance. Demonstrations will take place in booth 121 during exhibition hours.

“This expanded supplier quality solution further demonstrates RizePoint’s commitment to foster brand protection. We have enhanced the supplier onboarding experience, improved communication with suppliers, and made tracking compliance documents simple and easy.” – Frank Maylett, RizePoint

The update to the RizePoint enterprise compliance SaaS solution also includes:

  • Creating clear and simple onboarding workflows
  • Configuring forms and surveys based on your specific business needs
  • Building reports and dashboards that help you see into the health of supplier compliance
  • Setting due dates with automated alerts for expiring qualifying documents
  • Automating CAPA with triggered alerts and communications

About RizePoint

RizePoint offers a robust software solution that helps companies keep brand promises through their quality and compliance efforts. Our customers gather better data, see necessary actions earlier, and act faster to correct issues before they become costly liabilities. Considered the industry standard for food service, hospitality, and retail, RizePoint mobile and cloud-based solutions serve millions of audits every year. RizePoint is headquartered in Salt Lake City, Utah. For more information, visit RizePoint.com.

About Food Safety Consortium

The Food Safety Consortium is a premier educational and networking event for food safety solutions. Attracting the most influential minds in Food Safety, the Consortium enables attendees to engage conversations that are critical for advancing careers and organizations alike. Visit with exhibitors to learn about cutting edge solutions, explore five diverse educational tracks for learning valuable industry trends, and network with industry executives to find solutions to improve quality, efficiency and cost effectiveness in an ever-changing, global food safety market. Learn more about FSC at http://foodsafetyconsortium.net/.

Michael Koeris, Ph.D. and vice president of operations, Sample6, pathogen detection
FST Soapbox

The True Costs You Endure During a Food Recall

By Michael Koeris, Ph.D.
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Michael Koeris, Ph.D. and vice president of operations, Sample6, pathogen detection

When you think about the expense of a recall, you probably automatically focus on the costs to pull the affected product from shelves and reimburse customers. Yes, this can be an expensive undertaking. But the true, comprehensive cost of a recall involves immensely more than these obvious financial tolls. Do you fully understand the price to be paid when your organization is up against a food recall?

The recall process in the food manufacturing industry is a highly expensive one, averaging more than $10 million in costs to cover activities such as communicating the recall across the supply chain, retrieving and handling the recalled product, investigating the event and implementing corrective actions to prevent reoccurrence.

Of course, this average doesn’t address the possibility of litigation costs, decreased sales, reputational damage or brand crisis management, which can add up to millions—even billions— of dollars more. The public has become much more informed and aware of food safety events, and a single breach of trust could result in resounding losses to your brand. This makes it critical to understand the true costs you endure when faced with a food recall.

Immediate, Direct Costs

A recall can be a company-defining event. The vast majority of recalls are voluntary and a reflection of conscientious behavior by the retailers, wholesalers and producers, but that doesn’t mean you won’t incur serious expenses. The most obvious, immediate and direct ones include:

  • Pausing production to carry out recall response initiatives
  • Alerting necessary parties within and outside the organization, including regulatory agencies and relevant retailers
  • Managing the logistics of removing affected or mislabeled products
  • Examining the source of the recall, including issues with suppliers, equipment, processes or contamination prevention plans
  • Remediating the identified problems to prevent similar occurrences
  • Planning for expanded human resources to handle recall tasks in addition to routine operations

Again, these expenses could equate to millions of dollars from your bottom line, but the truth is they may be the most minor of your concerns in the face of a food recall.

Compliance Penalties

As you likely know by now, there’s a monumental shift happening in the regulatory arena. FSMA has enacted strict laws that place a greater emphasis on proactive and preventive approaches to food safety. In addition, the USDA has been focusing on strong enforcement of its guidelines for years.

For manufacturers, this means adjusting processes and procedures to comply with legal requirements for monitoring, testing, documentation, risk assessment and more. It is not enough for companies to have a plan for taking corrective action on contaminated products; they must also have a strong preventive plan in place to identify pathogens in the production environment before they affect the product and/or leave the facility. If your company undergoes an FDA or USDA audit or investigation that reveals noncompliance with government-mandated prevention efforts, you could be looking at significant consequences like criminal fines and forfeitures to the U.S. government.

FSMA laws and USDA regulations stipulate that depending on the nature of the violation, and whether the food is adulterated or misbranded, the FDA or USDA may consider regulatory actions, including:

  • Issuing advisory letters
  • Initiating court actions, such as seizure or injunction
  • Implementing administrative detention to gain control of adulterated or misbranded products
  • Mandating a recall of violative food
  • Suspending a facility’s food registration to prevent the shipment of food

Lawsuits and Litigation

According to the CDC, 48 million people get sick from foodborne illness each year, 128,000 are hospitalized and 3,000 die. If your organization is sued on the basis of a contaminated or unsafe product, you can expect to deal with attorney fees, court costs and settlements. In the worst cases, you may even need to pay damages to harmed consumers.

Yes, prosecutions are rare. But they are a reflection of a failure to protect consumers, as well as potential negligence or (in the rarest of cases) malicious intent. The financial effects of these reputational scars go well beyond obvious litigation expenses.

Lost Sales

Once a recall is ordered, a series of actions unfold that drastically impact your income. Manufacturers halt production, and retailers pull products from their shelves. Worse, a loss in consumer trust can initiate a long-lasting sales depression. Your customers want to know that the products they’re buying are safe. In response to a recall, they may change their purchasing, food preparation and consumption practices, or they may avoid the product for months or years after the recall has ended.

Insurance Impacts

Most food companies have recall insurance to protect their assets if a recall occurs. But, are you fully informed on what it means to work through a recall with your underwriter or how a recall affects your premiums? Is there a possibility of losing your insurance? It’s crucial to understand how your insurance is affected by a recall and what is contractually covered under your plan.

Brand Deterioration

Recalls are happening more frequently today than ever before, for reasons including stricter compliance regulations and supercharged government testing regimes using novel technologies like next-generation sequencing. This increased focus on testing by the government has led to a greater discovery rate of contamination, which is a good thing for the public. It means that improvements will be made to yield an even safer food production environment.

Nonetheless, recalls are alarming to your customers, and the last thing you want to risk is their trust in your brand. At the end of the day, your brand is your primary asset. It is a representation of who you are and how you do business. When recalls happen, customers lose faith in your brand, which comes with a hefty price tag for your company. If your brand deteriorates due to consumer mistrust, you’re risking business failure.

Unfortunately for the food industry, stories exposing scandals are a proven way to catch the public’s eye. Therefore, any news of a recall receives immediate and aggressive media coverage from both traditional and social media platforms. In the event of a recall, publicity is inevitable, and it’s an expense that spans every aspect from public relations management to eroded sales.

Prop 65 label

California Proposition 65 To Impact Food Labels

By Nick Recht
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Prop 65 label

The fast-approaching August 30th deadline for California’s Proposition 65 has food manufacturers of all sizes working to make sure affected labels comply with the new labeling requirements. According to the California Office of Environmental Health Hazard Assessment (OEHHA), Proposition 65:

“…requires businesses to provide warnings to Californians about significant exposures to chemicals that cause cancer, birth defects or other reproductive harm. These chemicals can be in the products that Californians purchase, in their homes or workplaces, or that are released into the environment. By requiring that this information be provided, Proposition 65 enables Californians to make informed decisions about their exposures to these chemicals.”

Proposition 65, also known as the Safe Drinking Water and Toxic Enforcement Act, is intended to help better equip Californians to make informed decisions about the products they purchase. The OEHHA is responsible for determining which chemicals meet the legal and scientific requirements for inclusion on the Proposition 65 list, a list which has grown to more than 900 chemicals since it was originally published in 1987.

The new law will be enforced by the California Attorney General’s Office as well as any district attorney or city attorney for cities whose population exceeds 750,000. Individuals acting in the public’s interest may also seek to enforce Proposition 65 by filing a lawsuit against companies alleged to be in violation. Companies that are found to be in violation may be fined as high as $2,500 per violation per day.

To ensure compliance with the new law, food manufacturers must reference the list of included chemicals to determine which of their products, if any, are impacted. Manufacturers must then provide “clear and reasonable warnings” that chemicals used in the production of their goods or products sold in California are known to cause cancer, birth defects and/or other reproductive harm. The ruling impacts goods sold in California as well as those sold via catalog or the internet.

Proposition 65 underscores the importance of an agile labeling environment for food manufacturers, particularly as it relates to their ability to adjust labels prior to compliance deadlines. It also implores manufacturers to look to automation to reduce the room for human error. For example, labeling software can be leveraged to create a table look up so if an impacted ingredient is included in a product and printed on a label, the required warning statement is also automatically included on the label.

Leveraging a database connection to apply such warnings can help businesses mitigate risk, as failing to include a required warning could result in fines, business disruption and lost revenue. It is also important to note that compliance with Proposition 65 will require food manufacturers to stay up to date on changes, as new chemicals may be added and/or revisions to law may continue to occur. Food retailers must also stay abreast of labeling changes required by Proposition 65 to ensure the products they sell are in compliance. Learn more about Proposition 65 at the OEHHA’s official website: https://www.p65warnings.ca.gov.

Prop 65 label
Label design products can help a company add a warning statement to a current label. Image courtesy of TEKLYNX.
Question mark

Return of FSMA IQ Test: Part IV

By Food Safety Tech Staff
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Question mark

Two years ago, Food Safety Tech published a series of six FSMA IQ tests to “test” industry’s knowledge about FSMA. It seemed appropriate, as at that point in time, folks still had a lot of unanswered questions. Now that we have a couple of years under our belt, how much to we know? We will publish each section of the test every week for the next six weeks. Then at this year’s Food Safety Consortium, the creators of the test–Bill Bremer, principal of food safety compliance at Kestrel Management, LLC and his team–will compare 2016 vs. 2018 during an interactive session. And if you have questions or comments on any of the elements brought up in the IQ test, please include them comments section below the test, so Bremer’s team can address them either live on our site or during the Consortium session.

Take Part III here.

Create your own user feedback survey

Question mark

Return of FSMA IQ Test: Part II

By Food Safety Tech Staff
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Question mark

Two years ago, Food Safety Tech published a series of six FSMA IQ tests to “test” industry’s knowledge about FSMA. It seemed appropriate, as at that point in time, folks still had a lot of unanswered questions. Now that we have a couple of years under our belt, how much to we know? We will publish each section of the test every week for the next six weeks. Then at this year’s Food Safety Consortium, the creators of the test–Bill Bremer, principal of food safety compliance at Kestrel Management, LLC and his team–will compare 2016 vs. 2018 during an interactive session. And if you have questions or comments on any of the elements brought up in the IQ test, please include them comments section below the test, so Bremer’s team can address them either live on our site or during the Consortium session.

Take Part I here. 

Create your own user feedback survey

2018 Food Safety Supply Chain Conference, Blockchain

Beyond Supply Chain Trends: Blockchain, FSMA, Food Fraud, Audits and More

By Maria Fontanazza
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2018 Food Safety Supply Chain Conference, Blockchain
Rick Biros, Priya Rathnam, and Andrew Seaborn, 2018 Food Safety Supply Chain Conference
Priya Rathnam (middle) pictured with Rick Biros, president of Innovative Publishing (left) and Andrew Seaborn Supervisory Consumer Safety Officer, Division of Import Operations, ORA, FDA

How well do you know your suppliers? Can you trust your supplier’s suppliers? What kind of technology are you using to assess and ensure your suppliers are in compliance with regulatory requirements? These are common questions food companies must ask themselves on a regular basis. These and more were addressed at the 2018 Food Safety Supply Chain Conference, held last week at USP in Rockville, MD. Stay tuned for coverage of the event in upcoming articles. In the meantime, here are some top insights shared by FDA and others in industry.

“We’ve issued a limited number of warning letters (two), and they were due to really egregious issues. Where there were previously warning letters issued, we’re seeing a lot more ‘regulatory meetings’.” – Priya Rathnam, Supervisory Consumer Safety Officer, CFSAN, on FDA’s enforcement this fiscal year.

Criteria for FSMA auditors also includes the “soft skills”, aka ISO 19011, auditor personal attributes. –Josh Grauso, Senior Manager, Food Safety & Quality System Audits, UL

Fabien Robert, Nestle 2018 Food Safety Supply Chain Conference
Food fraud costs the industry up to $15 billion annually. – Fabien Robert, Ph.D., Director, Nestle Zone America

It’s concerning that so many QA managers (and other pros) today don’t know extent of risk assessment they need to carry out. – Chris Domenico, Safefood360, Territory Manager for North America

“Blockchain is more than a buzzword at the moment.”- Simon Batters, Vice President of Technology Solutions, Lloyd’s Register

2018 Food Safety Supply Chain Conference, Blockchain
A dynamic panel about blockchain, led by Darin Detwiler, Director: Regulatory Affairs of Food and Food Industry, Northeastern University featured (left to right) Kathy Wybourn, Director, Food Safety Solutions, DNV Business Assurance; Simon Batters,Vice President of Technology Solutions, Lloyd’s Register and Melanie Nuce, Senior Vice President, Corporate Development & Innovation, GS1 US.

Sometimes food safety doesn’t win; sometimes you need the business acumen to show that implementing supply chain efficiencies will create the win. – Gina Kramer, Executive Director, Savour Food Safety International

Bryan Cohn, 2018 Food Safety Supply Chain Conference
Building a robust & smart supply chain = reduce food miles, shrink carbon footprint, and save food waste to increase revenue/acre. – Bryan Cohn, Vice President of Operations, Seal the Seasons

The FSMA Sanitary transportation rule is not as straightforward as you think. We need more training. – Cathy Crawford, President, HACCP Consulting Group