Tag Archives: imports

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FDA Releases Foods Program Priorities

By Food Safety Tech Staff
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The FDA has launched a new webpage listing food-related regulations that it plans to publish by October 2024 as well as longer-term regulations it is prioritizing for publication at a later date. The list includes 22 Foods Program regulations ranging from Certifications Concerning Imported Foods to Nutrient Content Claims and Amendments to Exemption Provisions in the Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption Regulation.

The three long-term action items relate to color and food additives.

The FDA also updated the list of guidance topics that it is considering and expects to publish by the end of 2024 to include five new guidances. They include:

  • Notifying FDA of a Permanent Discontinuance in the Manufacture or an Interruption of the Manufacture of an Infant Formula; Draft Guidance for Industry
  • Action Levels for Lead in Food Intended for Babies and Young Children: Guidance for Industry
  • The Food Traceability Rule: Questions and Answers; Draft Guidance for Industry
  • Hazard Analysis and Risk-Based Preventive Controls for Human Food; Chapter 12: Preventive Controls for Chemical Hazards: Draft Guidance for Industry
  • Voluntary Sodium Reduction Goals: Target Mean and Upper Bound Concentrations for Sodium in Commercially Processed, Packaged, and Prepared Foods (Edition 2): Draft Guidance for Industry

Public comments on the list of guidance topics can be submitted to www.regulations.gov using Docket ID FDA-2022-D-2088.

 

Cooked shrimp

FDA Launches Phase Three of AI Imported Seafood Pilot Program

By Food Safety Tech Staff
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Cooked shrimp

The FDA has launched the third phase of its Artificial Intelligence (AI) Imported Seafood Pilot program, which uses AI and machine learning (ML) to strengthen import screening to ensure that foods entering the U.S are safe.

The FDA chose to focus on seafood for the pilot program as more than 90% of the U.S. seafood supply comes from other countries, and the agency has seen food safety concerns for various imported seafood products along different points in the supply chain.

The program was implemented under the New Era of Smarter Food Safety Blueprint, a program that was developed to reduce the number of foodborne illnesses by leveraging technology to create a safer, more digital, traceable food system.

The third phase is designed to improve the agency’s ability to quickly identify imported seafood products that may be contaminated by illness-causing pathogens, decomposition, the presence of unapproved antibiotic residues or other hazards.

The first phase of the pilot, launched in 2019, was an analytical proof of concept. The analysis demonstrated potential for an ML-driven approach to expedite the review of lower-risk seafood shipments, while identifying those of higher risk for violations or refusals. The second phase, conducted in the field, was designed to integrate ML into existing import data systems to inform decisions about sampling by entry reviewers while gaining more experience with training of the ML model. It was launched at all 328 U.S. ports of entry from February 2021 through July 2021. The real-time model was able to analyze an import entry and return a sample recommendation within seconds.

The third phase will help determine the feasibility of deploying in-house AI/ML models using the intelligence that FDA extracts from the data collected while reviewing millions of import entries per year.

The agency notes that ML has the ability to analyze data from various sources to help inform FDA decisions and target resources at the borders. In a related shrimp pilot, the FDA was able to focus on areas of increased risk, such as shrimp contaminated by aquaculture drugs, for foreign inspections. “This includes increased importer inspections, higher rates of sampling and examination, and use of non-traditional tools, such as third-party audits, specific to this commodity. We incorporated the data from this project into the Third Phase of AI Imported Seafood Pilot Program, allowing for a more robust and larger targeted sampling,” said the FDA in a statement to constituents.

 

Susanne Kuehne, Decernis
Food Fraud Quick Bites

Food Imports Yes, Food Fraud No

By Susanne Kuehne
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Susanne Kuehne, Decernis
Food Fraud, China
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

Almost one third of imported foods in China were rejected due to fraud, according to a 10-year detailed study published in Food Control. The report states that processed foods accounted for over 87% of the fraudulent products. Drinks, candy, cookies and meat are the most frequently adulterated items. Artificial enhancement is the leading reason for adulteration—for example, undeclared food additives, prohibited veterinary drugs, ingredient substitutes and inedible adulterants. The study will assist in the prevention of food fraud for imports into China.

Resource

  1. Li, D., et al. (Publish date March 2022). “Food fraud of rejected imported foods in China in 2009–2019”. Science Direct. Food Control.
Susanne Kuehne, Decernis
Food Fraud Quick Bites

How Not To Sweeten the Deal

By Susanne Kuehne
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Susanne Kuehne, Decernis
Food fraud, Honey
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

Honey continues to be a popular target for fraudulent activity, as this latest case shows. A large number of batches of honey imported into Greece from inside and outside the European Union contained adulterants like added sugars and prohibited caramel colors, which was proven by chemical analysis. Honey produced in Greece was not affected. The adulterated products were immediately withdrawn from the market and the public was advised not to consume them.

Resource

  1. United Food Control Agency (April 16, 2021) “Recall of lots of honey”. EFET Portal.

 

Susanne Kuehne, Decernis
Food Fraud Quick Bites

Everything Is Not Peachy

By Susanne Kuehne
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Susanne Kuehne, Decernis
Food Fraud, Beverages
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

In a large case of trademark violations and counterfeiting, Haldiram, the leading snack manufacturer from India, filed a lawsuit against a Georgia-based distributor. The distribution company misused the well-known Haldiram label to import, distribute and sell counterfeit beverages, snacks, beverages and ready-to-eat meals in the United States, which is a large market for Haldiram. The company is seeking significant amounts of money for damages caused by the distributor and an immediate stop to the trademark infringements.

Resource

Taylor, P. (April 19, 2021). “Haldiram sues Georgia company, claiming counterfeiting”. Securing Industry.

Recall

JBS Recalls Nearly 5000 Pounds of Imported Australian Boneless Beef Due to Potential E. Coli Contamination

By Food Safety Tech Staff
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Recall
JBS Boneless Beef product
Label of recalled JBS Australia beef product. (Image from FSIS)

JBS USA Food Company is recalling about 4,860 pounds of imported raw and frozen boneless beef products over concern of contamination with E. coli O157:H7. The products were imported on or around November 10, 2020 and shipped to distributors and processors in New York and Pennsylvania.

The issue was uncovered during routine product sampling collected by FSIS, which confirmed positive for the presence of E. coli O157:H7, according to an FSIS announcement. “FSIS is concerned that some product may be frozen and in cold storage at distributor or further processor locations,” the announcement stated. “Distributors and further processors who received these products are urged not to utilize them.”

No illnesses or adverse reactions have been reported.

Susanne Kuehne, Decernis
Food Fraud Quick Bites

Don’t Let The Cat(fish) Out Of The Bag

By Susanne Kuehne
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Susanne Kuehne, Decernis
Catfish, food fraud
Find records of fraud such as those discussed in this column and more in the Food Fraud Database. Image credit: Susanne Kuehne

A multinational criminal smuggling ring was involved in the import of mislabeled siluriformes fish, including several species of catfish, into the United States. Import of such fish is prohibited to ensure the safety of the food supply in the United States. The smuggled catfish was labeled and listed on the import paperwork as other types of fish, which was discovered during a customs inspection. Subsequent seizures of shipping containers and warehouses led to the discovery of large amounts of mislabeled fish. The defendants face steep prison sentences.

Resources

  1. White, C. (February 22, 2021). “Catfish smuggling ring busted in New York City”. Seafood Source.
  2. “Four Alleged Smugglers Charged For Importing Banned Catfish Into The United States”. (February 18, 2021). U.S. Department of Justice. U.S. Attorney’s Southern District of New York.
Angel Suarez, EAS Consulting Group
FST Soapbox

Regulatory Cross Cutting with Artificial Intelligence and Imported Seafood

By Angel M. Suarez
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Angel Suarez, EAS Consulting Group

Since 2019 the FDA’s crosscutting work has implemented artificial intelligence (AI) as part of the its New Era of Smarter Food Safety initiative. This new application of available data sources can strengthen the agency’s public health mission with the goal using AI to improve capabilities to quickly and efficiently identify products that may pose a threat to public health by impeding their entry into the U.S. market.

On February 8 the FDA reported the initiation of their succeeding phase for AI activity with the Imported Seafood Pilot program. Running from February 1 through July 31, 2021, the pilot will allow FDA to study and evaluate the utility of AI in support of import targeting, ultimately assisting with the implementation of an AI model to target high-risk seafood products—a critical strategy, as the United States imports nearly 94% of its seafood, according to the FDA.

Where in the past, reliance on human intervention and/or trend analysis drove scrutiny of seafood shipments such as field exams, label exams or laboratory analysis of samples, with the use of AI technologies, FDA surveillance and regulatory efforts might be improved. The use of Artificial intelligence will allow for processing large amount of data at a faster rate and accuracy giving the capability for revamping FDA regulatory compliance and facilitate importers knowledge of compliance carrying through correct activity. FDA compliance officers would also get actionable insights faster, ensuring that operations can keep up with emerging compliance requirements.

Predictive Risk-based Evaluation for Dynamic Imports Compliance (PREDICT) is the current electronic tracking system that FDA uses to evaluate risk using a database screening system. It combs through every distribution line of imported food and ranks risk based on human inputs of historical data classifying foods as higher or lower risk. Higher-risk foods get more scrutiny at ports of entry. It is worth noting that AI is not intended to replace those noticeable PREDICT trends, but rather augment them. AI will be part of a wider toolset for regulators who want to figure out how and why certain trends happen so that they can make informed decisions.

AI’s focus in this regard is to strengthen food safety through the use of machine learning and identification of complex patterns in large data sets to order to detect and predict risk. AI combined with PREDICT has the potential to be the tool that expedites the clearance of lower risk seafood shipments, and identifies those that are higher risk.

The unleashing of data through this sophisticated mechanism can expedite sample collection, review and analysis with a focus on prevention and action-oriented information.

American consumers want safe food, whether it is domestically produced or imported from abroad. FDA needs to transform its computing and technology infrastructure to close the gap between rapid advances in product and process technology solutions to ensure that advances translate into meaningful results for these consumers.

There is a lot we humans can learn from data generated by machine learning and because of that learning curve, FDA is not expecting to see a reduction of FDA import enforcement action during the pilot program. Inputs will need to be adjusted, as well as performance and targets for violative seafood shipments, and the building of smart machines capable of performing tasks that typically require human interaction, optimizing workplans, planning and logistics will be prioritized.

In the future, AI will assist FDA in making regulatory decisions about which facilities must be inspected, what foods are most likely to make people sick, and other risk prioritization factors. As times and technologies change, FDA is changing with them, but its objective remains in protecting public health. There is much promise in AI, but developing a food safety algorithm takes time. FDA’s pilot program focusing on AI’s capabilities to strengthen the safety of U.S. seafood imports is a strong next step in predictive analytics in support of FDA’s New Era of Smarter Food Safety.

FDA

FDA Begins Phase Two of Artificial Intelligence Imported Seafood Pilot Program

By Food Safety Tech Staff
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FDA

FDA is beginning phase two of its Artificial Intelligence Imported Seafood Pilot Program. The program, which is expected to run from February 1 through July 31, intends to improve FDA’s response in quickly and efficiently identifying potentially harmful imported seafood products.

Phase one of the pilot looked at using machine learning to find violative seafood shipments. “The pilot program will help the agency not only gain valuable experience with new powerful AI-enabled technology but also add to the tools used to determine compliance with regulatory requirements and speed up detection of public health threats,” FDA stated in a news release. “Following completion of the pilot, FDA will communicate on our findings to promote transparency and facilitate dialogue on how new and emerging technologies can be harnessed to solve complex public health challenges.”

The pilot program is part of the agency’s efforts that fall under the New Era of Smarter Food Safety.

Karen Everstine, Decernis
Food Fraud Quick Bites

Food Authenticity: 2020 in Review

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

It is fair to say that 2020 was a challenging year with wide-ranging effects, including significant effects on our ongoing efforts to ensure food integrity and prevent fraud in the food system. COVID-19 caused major supply chain disruptions for foods and many other consumer products. It also highlighted challenges in effective tracking and standardization of food fraud-related data.

Let’s take a look at some of the notable food fraud occurrences in 2020:

  • Organic Products. The Spanish Guardia Civil investigated an organized crime group that sold pistachios with pesticide residues that were fraudulently labeled as organic, reportedly yielding €6 million in profit. USDA reported fraudulent organic certificates for products including winter squash, leafy greens, collagen peptides powder, blackberries, and avocados. Counterfeit wines with fraudulent DOG, PGI, and organic labels were discovered in Italy.
  • Herbs and Spices. Quite a few reports came out of India and Pakistan about adulteration and fraud in the local spice market. One of the most egregious involved the use of animal dung along with various other substances in the production of fraudulent chili powder, coriander powder, turmeric powder, and garam masala spice mix. Greece issued a notification for a turmeric recall following the detection of lead, chromium, and mercury in a sample of the product. Belgium recalled chili pepper for containing an “unauthorized coloring agent.” Reports of research conducted at Queen’s University Belfast also indicated that 25% of sage samples purchased from e-commerce or independent channels in the U.K. were adulterated with other leafy material.
  • Dairy Products. India and Pakistan have also reported quite a few incidents of fraud in local markets involving dairy products. These have included reports of counterfeit ghee and fraudulent ghee manufactured with animal fats as well as milk adulterated with a variety of fraudulent substances. The Czech Republic issued a report about Edam cheese that contained vegetable fat instead of milk fat.
  • Honey. Greece issued multiple alerts for honey containing sugar syrups and, in one case, caramel colors. Turkey reported a surveillance test that identified foreign sugars in honeycomb.
  • Meat and Fish. This European report concluded that the vulnerability to fraud in animal production networks was particularly high during to the COVID-19 pandemic due to the “most widely spread effects in terms of production, logistics, and demand.” Thousands of pounds of seafood were destroyed in Cambodia because they contained a gelatin-like substance. Fraudulent USDA marks of inspection were discovered on chicken imported to the United States from China. Soy protein far exceeding levels that could be expected from cross contamination were identified in sausage in the Czech Republic. In Colombia, a supplier of food for school children was accused of selling donkey and horse meat as beef. Decades of fraud involving halal beef was recently reported in in Malaysia.
  • Alcoholic Beverages. To date, our system has captured more than 30 separate incidents of fraud involving wine or other alcoholic beverages in 2020. Many of these involved illegally produced products, some of which contained toxic substances such as methanol. There were also multiple reports of counterfeit wines and whisky. Wines were also adulterated with sugar, flavors, colors and water.

We have currently captured about 70% of the number of incidents for 2020 as compared to 2019, although there are always lags in reporting and data capture, so we expect that number to rise over the coming weeks. These numbers do not appear to bear out predictions about the higher risk of food fraud cited by many groups resulting from the effects of COVID-19. This is likely due in part to reduced surveillance and reporting due to the effects of COVID lockdowns on regulatory and auditing programs. However, as noted in a recent article, we should take seriously food fraud reports that occur against this “backdrop of reduced regulatory oversight during the COVID-19 pandemic.” If public reports are just the tip of the iceburg, 2020 numbers that are close to those reported in 2019 may indeed indicate that the iceburg is actually larger.

Unfortunately, tracking food fraud reports and inferring trends is a difficult task. There is currently no globally standardized system for collection and reporting information on food fraud occurrences, or even standardized definitions for food fraud and the ways in which it happens. Media reports of fraud are challenging to verify and there can be many media reports related to one individual incident, which complicates tracking (especially by automated systems). Reports from official sources are not without their own challenges. Government agencies have varying priorities for their surveillance and testing programs, and these priorities have a direct effect on the data that is reported. Therefore, increases in reports for a particular commodity do not necessarily indicate a trend, they may just reflect an ongoing regulatory priority a particular country. Official sources are also not standardized with respect to how they report food safety or fraud incidents. Two RASFF notifications in 2008 following the discovery of melamine adulteration in milk illustrate this point (see Figure 1). In the first notification for a “milk drink” product, the hazard category was listed as “adulteration/fraud.” However, in the second notification for “chocolate and strawberry flavor body pen sets,” the hazard category was listed as “industrial contaminants,” even though the analytical result was higher.1

RASFF

RASFF, melamine detection
Figure 1. RASFF notifications for the detection of melamine in two products.1

What does all of this mean for ensuring food authenticity into 2021? We need to continue efforts to align terminology, track food fraud risk data, and ensure transparency and evaluation of the data that is reported. Alignment and standardization of food fraud reporting would go a long way to improving our understanding of how much food fraud occurs and where. Renewed efforts by global authorities to strengthen food authenticity protections are important. Finally, consumers and industry must continue to demand and ensure authenticity in our food supply. While most food fraud may not have immediate health consequences for consumers, reduced controls can lead to systemic problems and have devastating effects.

Reference

  1. Everstine, K., Popping, B., and Gendel, S.M. (2021). Food fraud mitigation: strategic approaches and tools. In R.S. Hellberg, K. Everstine, & S. Sklare (Eds.) Food Fraud – A Global Threat With Public Health and Economic Consequences (pp. 23-44). Elsevier. doi: 10.1016/B978-0-12-817242-1.00015-4