Tag Archives: harmonization

FDA

FDA Seeks $57 Million in Investments in Food Safety Modernization and Funding to Reduce Chemicals in Food

By Food Safety Tech Staff
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FDA

Today the FDA announced its budget request as part of the President’s 2023 fiscal year budget. Within the food sector, the agency is asking for $43 million for food safety modernization (including animal food safety) oversight—which includes efforts in continued implementation of the New Era of Smarter Food Safety initiative. The funding will also go towards improving preventative food safety practices, data sharing, predictive analytics and traceability, which will help the agency respond to outbreaks and recalls faster. “In partnership with states, the FDA will expand efforts to modernize, harmonize and transform the U.S. animal food inspection system to become more comprehensive and prevention oriented,” the FDA stated in an email release.

The FDA also requested $14 million in funding to reduce exposure to harmful chemicals and toxins in food. Last year the agency came under fire following a report released by Congress that stated there was an alarming amount of toxic heavy metals found in baby food. In response, the FDA devised a “Closer to Zero” action plan with a goal of reducing the presence of dangerous metals in foods commonly consumed by babies and young children. “Additional funding and legislative proposals will focus specifically on better protecting mothers, infants and young children through contamination limits in food, product testing requirements, notification of anticipated significant interruptions in the supply of infant formula or essential medical foods, as well as modernization of dietary supplement regulation,” the FDA stated.

Under the FDA’s funding requests that serve its core operations, the agency asked for $68 million for data modernization and enhanced technologies, which includes improving infrastructure aligned to the food programs; and $24 million to optimize inspections, including increasing support for recruiting and training new FDA investigators.

The FY budget covers October 1, 2022 through September 30, 2023.

Susanne Kuehne, Decernis
Food Fraud Quick Bites

Deter, Identify and Prosecute Food Fraud

By Susanne Kuehne
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Susanne Kuehne, Decernis
Canada, food fraud
Find records of fraud such as those discussed in this column and more in the Food Fraud Database, owned and operated by Decernis, a Food Safety Tech advertiser. Image credit: Susanne Kuehne

A study from the Canadian Arrell Food Institute lays out the current status of the fight against food fraud and a comprehensive list of interventions for governments, industry, suppliers, consumers, NGOs and academia. The focus is on collaboration along all stages of the food supply chain. Examples are global harmonization of regulations and testing, implementation of traceability systems, raising awareness for food fraud, using science to identify fraud, and much more.

Resource

  1. Hanner, R.H. and Kelly, J. (June 16, 2021). “Food Fraud in Canada – Understanding the Risks and Exploring Opportunities for Leadership”. Arrell Food Institute, Department of Integrative Biology, University of Guelph.

 

Karil Kochenderfer, LINKAGES
FST Soapbox

GFSI at 20 YEARS: Time for a Reboot?

By Karil Kochenderfer
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Karil Kochenderfer, LINKAGES

The marketplace has experienced dramatic changes that were barely on the horizon 20 years ago—by that, I mean mobile phones, Instagram, Facebook, climate change, consumer transparency, globalization, novel new products delivered to your doorstep and now COVID-19, too.

I write from a perspective of both pride and concern. I had the privilege of representing GFSI in North America and helping the organization expand beyond Europe as new food safety laws were implemented in both the United States and Canada.

Questionable Utility of Multiple, Redundant and Costly Certifications

However, I also sympathized with small and medium food companies that struggled with minimal resources and food safety expertise to understand GFSI and then to become certified not once, but multiple times for multiple customers. GFSI’s mantra, “Once Certified, Accepted Everywhere,” was far from their GFSI reality…or, frankly, the reality of many food companies. My concern was not insignificant. The food industry is populated by a majority of small businesses, each seeking that one big break that could possibly, maybe open up access to retail shelves. Their confusion about being audited and certified to one standard was significant. Certification to multiple and redundant standards presented a daunting and costly endeavor for these start-ups. I heard their anxiety in their voices as I served as GFSI’s 1.800 “customer service rep” in North America for years.

Karil Kochenderfer will present “GFSI at 20 Years: Time for a Reboot?” during the 2020 Food Safety Consortium Virtual Conference Series | Her session takes place on December 17Transparency

In the 20 years since GFSI was established, the world has become much more transparent. Today, entire industries operate on open, international, consensus-based ISO management standards in far bigger and more complex sectors than the food sector (e.g., the automotive, airline and medical device sectors). And, in the 20 years since GFSI was established, an ISO food safety management system standard has been developed that is now used widely throughout the world with more than 36,000 certifications (i.e., ISO 22000).

Auditing and certifying a facility to a single, international, public standard would enhance GFSI transparency. It also would help to hurdle government concerns related to the lack of public input into the development of private standards, enabling private certifications like GFSI to be used efficiently as a compliance tool—a benefit to both government and food interests and to consumer health, safety and trade.

New Technologies

Many new technologies, such blockchain, artificial intelligence, sensors and the Internet of Things are being heralded widely now as well, particularly for businesses with complex supply-chains like those in like the fast-moving food and retail sectors. The benefits of these technologies are predicated on the use of a common digital language…or standard. Multiple and diverse standards, like GFSI, complicate the use of these new technologies, which is why FDA is examining the harmonizing role of standards and data management in its proposed New Era of Smarter Food Safety.

Sustainable Development

Today, food safety often is managed in tandem with other corporate environment, health and safety programs. The Consumer Goods Forum, which oversees GFSI, should take a similar approach and merge GFSI with its sustainability, and health and wellness programs to help CGF members meet their existing commitments to the United Nations’ Sustainable Development Goals (SDGs) and to encourage others to do the same. Here, once again, adoption of a single, transparent ISO standard can help. Adoption of ISO 22000 as the single and foundational standard for GFSI makes it easy to layer on and comply with other ISO standards—for example, for the environment (ISO 14000), worker protection (ISO 45001), energy efficiency (ISO 50001) and information/data security (ISO 27001)— and to simultaneously meet multiple SDGs.

Globalization

As I write, the COVID pandemic rages. It may re-align global supply chains and set back global trade temporarily, but the unprecedented rise in consumer incomes and corresponding decrease in poverty around the world attests to the importance of the global trade rules established by the World Trade Organization (WTO). Among these rules is a directive to governments (and businesses) to use common standards to facilitate trade, which uniquely recognizes ISO standards as well as those of Codex and OIE. When trade disputes arise, food interests that use ISO 22000 are hands-down winners, no questions asked. So, why use many and conflicting private standards?

Supply Chain Efficiency

Finally, ISO 22005, part of the ISO 22000 family of food management standards, also is aligned with GS1 Standards for supply-chain management, used throughout the food and retail sectors in North America and globally to share information between customers and suppliers. GS1 is most well known for being the administrators of the familiar U.P.C. barcode. The barcode and other “data carriers” provide visibility into the movement of products as well as information about select attributes about those products—including whether they have been certified under GFSI. Both GS1 and ISO GS1 standards are foundational to the new technologies that are being adopted in the fast-moving food, consumer products, healthcare and retail sectors both in the United States and globally. That alignment puts a spotlight on safety, sustainability, mobility, efficiency and so much more.

Focus Less on the Change, More on the Outcome

My proposal will surely set tongues in motion. Proposals to switch things up generally do. Disruption has become the norm, however, and food businesses are prized for their agility and responsiveness to the endless changes in today’s fast-moving marketplace. Still, ISO and Codex standards already are embedded in the GFSI benchmark so what I’m proposing should not be so disruptive and no one scheme or CPO should benefit disproportionately. And, less differentiation in the standard of industry performance will compel scheme or certification owners to shift their focus away from compliance with their standards and audit checklists to working with customers to truly enhance and establish “food safety-oriented cultures.” If they do, all of us emerge as winners.

The New Normal?

Around us new food businesses are emerging just as old businesses reinvent theirs. Trucks now operate as restaurants and athletes deliver dinner on bicycles. For a long time, we’ve operated businesses based on 20th century models that don’t resonate in the 21st century world. Are we at an inflection point, with both small and large businesses paying for costly and inefficient practices that no longer apply, and is it time for GFSI to change?

I welcome your thoughts. I truly do. Better, let’s discuss on a webinar or video call of your choosing. I look forward to connecting.

Submit questions you want Karil to answer during her session at the 2020 Food Safety Consortium Virtual Conference Series in the Comments section below.

Checklist

2020 FSC Episode 4 Wrap: FDA: There’s a Strong Business and Public Health Case for Better Traceability

By Maria Fontanazza
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Checklist

One year ago the FDA held an at-capacity public meeting to discuss its latest initiative, the New Era of Smarter Food Safety. At the time, the agency was planning to release the blueprint for the New Era in the spring of 2020. In fact, the FDA was just days away from unveiling it when the COVID-19 pandemic hit in March. The blueprint was put aside and it was all hands on deck, as the agency worked with the food industry to ensure companies continued operating, as they were deemed a part of America’s critical infrastructure. From there, the agency navigated through uncharted waters with the food industry and its stakeholders. It signed an MOU with USDA in an effort to prevent disruptions at FDA-regulated food facilities and address shortages of PPE, disinfection and sanitation supplies. It announced that it would conduct remote inspections and extended the comment period for the Laboratory Accreditation Program Proposed Rule. It released a COVID-19 food safety checklist with OSHA to help guide companies through employee health, social distancing, and the operational issues that have entered into play as a result of the pandemic. Food companies and the supply chain were facing an enormous challenge.

“I always thought we had one of the best food systems in the world… by and large we have an amazing food system,” said Frank Yiannas deputy commissioner for food policy and response during last week’s keynote address at the 2020 Food Safety Consortium Virtual Conference Series. “We just experienced the biggest test on the food system in 100 years. Have we passed the test? I don’t think anyone would say we scored 100%… but by and large we passed the test.” Yiannas added that COVID-19 has exposed some strengths and weaknesses in the food system as well. He also emphasized a point that he has been driving home throughout the pandemic: “The virus that causes COVID-19 is not a virus that is transmitted by food. It is a respiratory virus and generally transmitted in very different ways.”

The FDA released the blueprint for the New Era of Smarter Food Safety, which incorporated some lessons learned from COVID-19, in July. Traceability is a big part of agency’s new era initiative, and the pandemic further put a spotlight on the need for better tracking and tracing in the food industry. And under FSMA, FDA is required to “establish a system that will enhance its ability to track and trace both domestic and imported foods”. In working to meet this requirement, FDA proposed the FSMA rule on food traceability last month.

Yiannas said the proposed rule has the potential to lay the foundation for meaningful harmonization and called aspects of the proposed rule game changing. It establishes two critical components that are the leading edge of food traceability: It defines critical tracking events (i.e., what are the types of events in the food system that required those events to be kept) and key data elements (i.e., the data elements that must be captured at those critical tracking events). “These two things are big ideas for traceability,” said Yiannas. “They will allow us to harmonize how traceability is to be done, allow us to scale and allow for greater interoperability.” The proposed rule also creates a traceability list that identifies foods based on a risk-ranking model for food tracing.

FDA is encouraging comments on the proposed rule and is holding three meetings (November 6, November 18 and December 2) to discuss the proposed traceability rule. “We are going to create the final rule together,” said Yiannas.

As part of a special offering, Episode 4 has been made available for viewing on demand for free. Register to view the on-demand recording.

Karen Everstine, Decernis
Food Fraud Quick Bites

How Food Fraud Happens

By Karen Everstine, Ph.D.
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Karen Everstine, Decernis

The food industry has been hard at work over the past few years implementing food fraud mitigation plans in response to Global Food Safety Initiative (GFSI) certification program requirements. GFSI defines food fraud as:

“A collective term encompassing the deliberate and intentional substitution, addition, tampering or misrepresentation of food, food ingredients or food packaging, labelling, product information or false or misleading statements made about a product for economic gain that could impact consumer health.” (GFSI Benchmarking Requirements, 2017)

GFSI then further defines the terminology of food fraud by citing seven categories (shown in the following diagram).

GFSI, Food Fraud
Used with permission from GFSI

In the Food Fraud Database, we categorize food fraud records using the following terminology (with examples):

  • Dilution/substitution
    • Substitution of an entire fish fillet or partial dilution of olive oil with another oil
  • Artificial enhancement
    • Addition of melamine to artificially increase the apparent protein content of milk or the addition of coloring agents to spices
  • Use of undeclared, unapproved, or banned biocides
    • The use of chloramphenicol in honeybee populations (where not permitted) or the addition of hydrogen peroxide to milk
  • Removal of authentic constituents
    • The sale of “spent” spice powder (used in the production of an oleoresin) as a whole spice powder
  • Misrepresentation of nutritional value
    • Infant formula that does not contain the required nutritional content
  • Fraudulent labeling claims
    • Misrepresentation of label attributes related to production method (organic, kosher, halal, etc.)
  • Formulation of an entirely fraudulent product (using multiple adulterants and methods)
    • The sale of “100% apple juice” that consists of sugar, water, malic acid, flavor, and color
  • Other
    • This includes counterfeits, theft, overruns, etc.

Harmonization of food fraud terminology is frequently discussed, so I thought it might be useful to provide information on how our definitions relate to the GFSI terminology:

GFSI category “Dilution”: This category maps directly to our category dilution/substitution. The reason we combine these into one category is that the intent is the same: To replace the weight or volume of a product. This can occur either through partial or full substitution of a liquid product, a granulated product, or swapping an entire intact product such as a fish filet. One of the GFSI examples for substitution is “sunflower oil partially substituted with mineral oil”, which could just as accurately be described as dilution.

GFSI category “Substitution”: As noted above, this category maps directly to our category dilution/substitution. However, we would not consider the use of hydrolyzed leather protein in milk (one of the cited examples) to be dilution/substitution because it is not used to replace weight or volume. We would view that as artificial enhancement of the protein content of milk.

GFSI category “Concealment”: We do not include a category focused on concealment because all food fraud involves concealing some aspect of the true contents of the food. One of the examples cited in this category is “poultry injected with hormones to conceal disease.” The use of antibiotics, anti-fungal agents or other substances to reduce bacterial load or mask deterioration would be classified, in our system, as the use of undeclared, unapproved or banned biocides. The use of coloring agents on fruit to improve appearance would also be classified as artificial enhancement.

GFSI category “Mislabeling”: Since all food fraud is, to some extent, mislabeling, we reserve the use of the term fraudulent labeling claims to those label attributes that describe production processes (organic, kosher, etc.). With the exception of falsification of expiration dates, the other examples cited would not be classified by us as mislabeling. The sale of Japanese star anise, which is potentially toxic, as Chinese star anise (a different species) is dilution/substitution and a health risk to consumers. The sale of cooking oil that has been recovered from waste streams and illegally produced is also a form of substitution that poses a potential health risk to consumers.

GFSI category “Unapproved enhancements”: This GFSI category aligns nicely with our category artificial enhancement, and both examples cited are nicely illustrative of the concept, which involves the fraudulent addition of a substance specifically for its function (not as a replacement for weight or volume).

GFSI Category “Gray market production/theft/diversion”: The production and sale of food products through unregulated channels would all be classified in our category called other. Because these forms of food fraud involve the sale of food outside of regulatory control, prevention measures will generally be substantially different from the prevention of fraud within legitimate supply chains.

GFSI Category Counterfeiting: This GFSI category is similar to the gray market production/theft/diversion category in that it involves intellectual property infringement and production outside of regulatory control. It would similarly be classified in our other category.

GFSI

GFSI Releases Version 7.1 to Incorporate More Harmonization

By Food Safety Tech Staff
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GFSI

GFSI has just released a new benchmarking requirements version that was developed for food safety certification schemes. Following stakeholder input, Version 7.1 intends to reflect changes happening in the market. The new version includes the addition of clauses for each scope under Food Safety Management requirements, including purchasing from non-approved suppliers and compliance with food safety legislation.

The previous version, Version 7, was released in February and introduced requirements to combat food fraud, incorporate unannounced audits, and increase transparency in the benchmarking process. It also included a new scope of supply chain food brokers and agents.

GFSI and SENASICA

GFSI 2017: Working for International Partnerships and Global Harmonization

By Food Safety Tech Staff
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GFSI and SENASICA

There were several common threads during last week’s GFSI conference—collaboration to build stronger and more transparent food safety systems, international partnerships, and a global supply chain. This year’s event saw a record-breaking turnout, with nearly 1200 industry professionals from 54 countries in attendance.

GFSI and SENASICA
(left) Mike Robach, Vice President, Corporate Food Safety, Quality & Regulatory for Cargill, Inc. USA & Chair of the GFSI Board of Directors and (right) Hugo Fragoso of SENASICA

For the first time, GFSI entered into a public-private partnership with the Mexican National Service of Health, Food safety and Agro-Food Quality (SENASICA) that will help the entities to reach the goal of continuous improvement in food safety management systems. GFSI and SENASICA will sign a letter of intent this week in Mexico City. The partnership will focus on enabling private schemes to act under Mexican regulation (in addition to the Certification of the official scheme) to increase the amount of officially certified products. The two entities will also work together to enhance Mexico’s Global Markets Programme. The hope is that the partnership will be a model for other countries and will promote the adoption of third-party certification that facilitates the harmonization of food safety systems and global requirements.

Other highlights included a G30 summit held by 30 countries to talk about food safety and international harmonization; the work between GFSI and Certification Programme Owners to improve auditor performance; and the first GFSI award, which went to Champion Petfoods.