USDA’s Food Safety and Inspection Service (FSIS) has announced its final determination to declare Salmonella an adulterant in raw breaded stuffed chicken products when they exceed a specific threshold of 1 colony forming unit (CFU) per gram or higher for Salmonella contamination.

This determination is part of the agency’s efforts to reduce Salmonella illnesses associated with the raw poultry supply in the U.S. FSIS intends to address Salmonella contamination in other raw poultry products later this year.

“This final determination marks the first time that Salmonella is being declared an adulterant in a class of raw poultry products,” said Tom Vilsack, agriculture secretary, in an April 26 statement. “This policy change is important because it will allow us to stop the sale of these products when we find levels of Salmonella contamination that could make people sick.”

FSIS will carry out verification procedures, including sampling and testing of the raw incoming chicken component of these products prior to stuffing and breading, to ensure producing establishments control Salmonella in these products. If the chicken component in these products does not meet this standard, the product lot represented by the sampled component would not be permitted to be used to produce the final raw breaded stuffed chicken products. The determination, including FSIS’ sampling and verification testing, will be effective 12 months after its publication in the Federal Register.

In determining that Salmonella is an adulterant in raw breaded stuffed chicken products, FSIS considered the best available science and data using similar criteria as in its 1994, 1999, and 2011 E. coli policymaking. When FSIS declared seven Shiga toxin-producing E. coli (STEC) strains to be adulterants in select raw beef products, it relied on several factors, including the available information on serotypes linked to human illnesses, infectious dose, severity of illnesses and typical consumer preparation practices associated with a product. The breaded stuffed chicken products determination relied on the same factors.

FSIS and its public health partners have investigated 14 Salmonella outbreaks and approximately 200 illnesses associated with these products since 1998. The most recent outbreak was in 2021 and resulted in illnesses across 11 states. These products account for less than 0.15% of the total domestic chicken supply, but outbreaks linked to these products represented approximately 5% of all chicken-associated outbreaks in the U.S. from 1998 to 2020.

Raw breaded stuffed chicken products are pre-browned and may appear cooked, but the chicken is raw. The products are typically cooked by consumers from a frozen state, which increases the risk of the product not reaching the internal temperature needed to destroy Salmonella. Despite to improve labeling, these products continue to be associated with Salmonella illness outbreaks.

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To further protect the U.S. livestock industry from the threat posed by highly pathogenic H5N1 avian influenza, USDA has announced that it is taking specific actions with its federal partners to limit the disease’s spread.

USDA’s Animal and Plant Health Inspection Service (APHIS) announced a Federal Order requiring the following measures, effective Monday, April 29, 2024:

Mandatory Testing for Interstate Movement of Dairy Cattle

• Prior to interstate movement, dairy cattle are required to receive a negative test for Influenza A virus at an approved National Animal Health Laboratory Network laboratory.
• Owners of herds in which dairy cattle test positive for interstate movement will be required to provide epidemiological information, including animal movement tracing.
• Dairy cattle moving interstate must adhere to conditions specified by APHIS.
• As will be described in forthcoming guidance, these steps will be immediately required for lactating dairy cattle, while these requirements for other classes of dairy cattle will be based on scientific factors concerning the virus and its evolving risk profile.

Mandatory Reporting

• Laboratories and state veterinarians must report positive Influenza A nucleic acid detection diagnostic results (e.g. PCR or genetic sequencing) in livestock to USDA APHIS.
• Laboratories and state veterinarians must report positive Influenza A serology diagnostic results in livestock to USDA APHIS.

USDA has identified spread between cows within the same herd, spread from cows to poultry, spread between dairies associated with cattle movements, and cows without clinical signs that have tested positive. On April 16, APHIS identified a shift in an H5N1 sample from a cow in Kansas that could indicate that the virus has an adaptation to mammals.

CDC conducted further analysis of the specimen sequence, which did not change their overall risk assessment for the general public, because the substitution has been seen previously in other mammalian infections and does not impact viral transmission. Additionally, the APHIS National Veterinary Services Laboratories found H5N1 in a lung tissue sample from an asymptomatic cull dairy cow that originated from an affected herd and did not enter the food supply.

The novel movement of H5N1 between wild birds and dairy cows requires further testing and time to develop a critical understanding to support any future courses of action, USDA said in a statement, adding that requiring positive test reporting will help the agency better under the disease and testing before interstate movement will limit its spread.

The agency has not found changes to the virus that would make it more transmissible to humans and between people and CDC believe that the current risk to the public remains low.

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Robert Califf, FDA’a commissioner, reiterated the agency’s year-old appeal to Congress for a framework enabling the sale of cannabidiol (CBD) as a dietary supplement and as a food ingredient. Currently, FDA believes it lacks the authority to pursue this course of action within its existing structure.

Califf addressed a U.S. House of Representatives oversight committee earlier this month and noted that FDA deemed hemp-derived CBD not sufficiently safe for lawful sale as a dietary supplement. He urged Congress to establish a pathway for regulating the substance.

Based on a recent report from the World Health Organization (WHO), CBD shows promising therapeutic potential in various trials, both controlled and open label, demonstrating good tolerance and a favorable safety profile.

The regulation of hemp derivatives, including CBD, has been a matter of concern since the legalization of its cultivation in the 2018 Farm Bill, predominantly crafted by USDA and ratified by Congress. Since then, the product has become widespread as a supplement and has also found its way into certain food and beverage items, despite FDA never officially declaring it safe as a food ingredient. “It’s Congress’s decision to make, so we would really look forward to work with you all as quickly as possible to come up with a regulatory pathway that you think is reasonable and enables us to take action,” Califf said during his address.

James Comer, chairman of the House Committee on Oversight and Accountability, sent a letter to Califf on Wednesday in reply, stating it is imperative that FDA engages in this regulation quickly, safely, and efficiently to provide proper guidance to consumers about the safety of CBD products. “Without allowing for therapeutic CBD products to be regulated as dietary supplements such as melatonin or fish oils, the good faith actors in the industry are unable to enter the market and provide people with helpful products because they are currently not distinguished under the FDA from the intoxicating products containing Delta-8,” he wrote, asking FDA for documents and information to enable oversight of the agency’s actions.

Another issue gaining steam revolves around the national legalization of tetrahydrocannabinol (THC), the intoxicating component of marijuana, and its potential integration into food and beverage items. While some states where the drug is already legalized have incorporated it into food products, interstate transportation of such products remains prohibited.

Califf has gone on record declaring there is no justification for the Drug Enforcement Administration (DEA) to prolong its decision regarding the rescheduling of marijuana from a Schedule I to a Schedule III substance, thereby aligning it with medications such as acetaminophen and ketamine, rather than with substances like heroin and LSD.

“This is an area where I believe we would be better off if we had guidance from Congress about how to proceed,” Califf said.

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A California assembly member has introduced legislation that would prohibit the state’s public schools from serving foods that contain certain additives. In particular, Assembly Bill (AB) 2316, introduced by Jesse Gabriel (D-Encino), would prohibit schools from serving foods containing six synthetic food dyes—Red 40, Yellow 5, Yellow 6, Blue 1, Blue 2, and Green 3.

Currently, products containing these dyes are required by the EU to carry a warning label.

The introduction of AB 2316 follows the 2023 passage California Food Safety Act – which banned the use of four chemicals from foods sold in California. Like the California Food Safety Act, AB 2316 would not ban any specific foods or products; rather, Gabriel says it would encourage companies to make modifications to products sold in the state.

AB 2316 now heads to the Assembly Education Committee, where it is expected to be heard in the coming weeks.

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USDA has finalized a rule to align the voluntary “Product of USA” label claim with consumer understanding of what the statement means. Tom Vilsack USDA agriculture secretary, also says the agency is awarding $9.5 million to 42 projects through the Local Meat Capacity grant program to expand processing options for the meat and poultry industry and new actions to ensure transparency and a fair and competitive market in the U.S seed industry.

These actions build on President Biden’s Executive Order on Promoting Competition in the American Economy and the Biden-Harris Administration’s Action Plan for a Fairer, More Competitive, and More Resilient Meat and Poultry Supply Chain, the agency says, adding that they are intended to help increase competition in agricultural markets, create a fairer playing field for small- and mid-size farmers, lower grocery costs for consumers, and strengthen local and regional food systems.

The final rule allows the voluntary “Product of USA” or “Made in the USA” label claim to be used on meat, poultry and egg products only when they are derived from animals born, raised, slaughtered and processed in the United States. The rule will prohibit misleading U.S. origin labeling in the market and help ensure that the information that consumers receive about where their food comes from is truthful.

Under the rule, the label claim will continue to be voluntary. It will also remain eligible for generic label approval, meaning it would not need to be pre-approved by USDA’s Food Safety and Inspection Service (FSIS) before it can be used on regulated product but would require the establishment to maintain documentation on file to support the claim. The final rule also allows the use of other voluntary U.S. origin claims on meat, poultry and egg products sold in the marketplace. These claims will need to include a description on the package of the preparation and processing steps that occurred in the United States upon which the claim is made.

USDA has also published an updated labeling guidance on the use of voluntary U.S.-origin label claims to provide examples of claims and the types of documentation that establishments may maintain to support use of the claims. The guidance will be open for public comment for 60 days after publishing in the Federal Register. Public comments can be submitted at www.regulations.gov.

Establishments voluntarily using a claim subject to the final rule will need to comply with the new regulatory requirements by January 1, 2026.

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FDA has announced that grease-proofing materials containing per- and polyfluoroalkyl substances (PFAS) are no longer being sold for use in food packaging in the U.S. This means the major source of dietary exposure to PFAS from food packaging like fast-food wrappers, microwave popcorn bags, take-out paperboard containers, and pet food bags has been eliminated.

PFAS, also known as “forever chemicals” are a diverse group of thousands of chemicals that resist grease, oil, water, and heat. FDA has authorized certain of these substances for limited use in cookware, food packaging, and food processing equipment. Exposure to some types of PFAS have been linked to serious health effects.

The announcement marks the fulfillment of a voluntary commitment by manufacturers to not sell food contact substances containing certain PFAS intended for use as grease-proofing agents in the U.S. “This FDA-led effort represents a positive step forward as we continue to reevaluate chemicals authorized for use with, and in, food,” said Jim Jones, deputy commissioner for human foods, in a statement. In 2020, the FDA engaged companies to cease sales of grease-proofing substances that contain certain types of PFAS following a post-market safety assessment conducted by the agency.

FDA says it will continue to conduct research and update its evaluations using the most up-to-date science to ensure that its risk determinations continue to be accurate and based on current science.

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The food and beverage landscape is rapidly evolving, driven by shifting consumer preferences, emerging market opportunities, and changing trends. Food and beverage manufacturers in the U.S. and worldwide face a host of pressures that demand a fresh approach to stay competitive.

New product development (NPD) and reformulation are pivotal in keeping these companies at the forefront of the food industry; however, the journey from concept to consumer is complex, marked by a failure rate ranging from 30% to 40%, according to a 2022 report published in the Journal of Marketing and Consumer Behaviour in Emerging Markets. (doi: 10.7172/2449-6634.jmcbem.2022.1.4) To launch to market quickly, companies must rapidly translate consumer insights into innovative products, source safe ingredients, and navigate the commercialization process while avoiding compliance issues that erode consumer trust.

Embedding compliance insights throughout the product development process can not only enhance innovation but also increases speed, collaboration, data utilization, productivity, and resilience. Additionally, taking a proactive approach to compliance can lead to stable and future-proof products that are capable of meeting ever-evolving regulations and customer requirements.

Navigating Product Development Challenges

Guarding against safety and compliance risks is critical for food and beverage brands, and the stakes are high; compliance issues can erode consumer trust and result in substantial costs, both as an immediate financial impact and for a brand’s reputation. The average cost of a product recall, including notification, product retrieval, storage, replacement, and destruction, can reach up to $10 million, while larger recalls can exceed $100 million.

The complexities of the global market have further amplified these risks. As supply chains expand and become more interconnected across borders, the integrity and transparency of these networks are tested. Natural disasters, geopolitical events, cyberattacks, and other disruptions are increasingly commonplace, with 56% of companies worldwide suffering some form of supply chain disruption each year, according to a 2022 report published in the Annals of Operations Research (doi: 0.1007/s10479-020-03912-1). Risks now cascade worldwide through supply networks, emphasizing the need for agility and resilience in product development, procurement, and compliance.

In this pressurized environment, the U.S. food and beverage industry is experiencing a surge in workload. This increase is straining processes and tools that were once effective. To adapt to this new landscape, innovative solutions are required to handle the heightened volume and complexity while providing superior quality, efficiency, and insights.

The Power of Regulatory Insight

Regulatory insight is the key to navigating this challenging terrain. In the current product development model, organizational silos often hinder efficient innovation. Compliance is viewed as an obstacle rather than an enabler, while manual processes slow down data sharing and impede productivity. Outdated systems are ill equipped to handle the ever-increasing complexity of requirements.

In addition, legacy workflows can also struggle to support the industry’s evolving needs. Rigid hand-off sequences between functions create bottlenecks that prolong development cycles, increase risk exposure, delay product launches, and affect revenue generation. Meanwhile, the late-stage discovery of compliance issues frequently leads to expensive modifications that eat into profit margins.

Compliant Design

To address these challenges, the food and beverage industry is turning to an approach called compliant design, which involves proactively embedding compliance checks and data-driven insights into the product development process—from the concept stage onward. Compliant design not only accelerates innovation but also reduces risk and improves opportunities for collaboration, leading to more stable and future-proof products.

By understanding today’s key regulations and anticipating those of tomorrow, brands can begin to think in the longer term, avoiding decisions that could lead to product reformulation shortly after launch. Improved tools and enhanced compliance visibility empower teams to make decisions that satisfy initial requirements, while also ensuring the ease of future compliance and increased sales through additional claims that enhance market opportunities.

For example, when choosing flavorings or colorings, manufacturers can simulate product scenarios to ensure that compliance is met in multiple markets. This strategy guarantees informed choices that maximize resources and opportunities. Plus, it prevents costly late-stage redesigns that occur when compliance issues are discovered at the last minute, and fosters faster, more resilient innovation cycles that are driven by real-time data.

Shift Left to Achieve Efficiency

Inspired by the world of software development, shifting left moves testing and QC processes to a point earlier in the development cycle so that manufacturers can tackle unforeseen issues before it is too late or added costs occur.

Considering compliance during design stages also offers several organizational advantages, including reduced time to market through faster, informed decision-making that reduces costly holdups that can occur when regulatory input is provided later in the process. Additionally, by empowering non-regulatory stakeholders to access compliance insights independently, organizations can reduce issues with prototypes while minimizing back-and-forth communication during the process.

A shift-left approach also enables product developers to take multiple market formulations into consideration by including potential additional markets’ regulatory requirements from the outset. This subsequently improves second-round innovation speed by ensuring the early selection of appropriate ingredients and suppliers. The early identification of potential ingredient risks can help mitigate issues involving safety, quality, or scarcity caused by factors such as supplier quality, geopolitical conditions, or climate. Insights into changes in consumer trends and the regulatory landscape can also help prevent unnecessary reformulations.

Improve Collaboration

Compliance in design helps to break down organizational silos between teams such as R&D and regulatory affairs, promoting greater organizational efficiency. This, in turn, reduces churn and disconnect across these teams, minimizing iterations and latency throughout the process. By integrating compliance intelligence into product design and fostering cross-functional transparency, R&D teams can make supported decisions early on, creating innovative prototypes that are highly compliant from the outset.

This approach provides the various business functions with improved visibility into all processes and constraints, promoting cross-departmental understanding and connection. It also reframes the regulatory team as an essential collaborator rather than a roadblock, shifting the focus toward creating more value-added opportunities that drive innovation and transformation for the business, while reducing the time spent on monotonous validation exercises, such as searching for regulations, inputting data, and manually assessing compliance requirements. By capturing organizational knowledge within a centralized hub integrated with product lifecycle management (PLM) and enterprise resource planning (ERP) tools, decision makers can leverage organizational standards and historical insights to drive continuous improvement, resulting in higher quality products.

Centralized, up-to-date regulatory and product data repositories also reduce the time spent scanning fragmented information sources. Proactive alerts on regulatory and supply chain issues enable a “manage by exception” approach to risk mitigation, replacing the effort required for manual issue monitoring. R&D teams can dedicate more time to “Big I” innovation, as opposed to reworking products to meet compliance requirements. Regulatory teams spend less time trying to connect the dots; instead, they create the space to pursue important objectives, including policy feedback, advocacy, and stakeholder education.

An essential success factor for compliant design is having these capabilities thoughtfully integrated into the process. Integrating compliant design solutions into current PLM and ERP systems fuels transformation without disruption, enhancing existing development and NPD processes and leading to high-value realization for the effort. Integration for ease of adoption is crucial, as it minimizes the need for retraining and keeps change management minimal. Organizational buy-in is the natural result, as teams watch the technology take on many more tasks and improve outcomes.

Harmonize AI and Human Expertise

Compliant design harnesses machine learning and artificial intelligence (AI) alongside human expertise to unlock the true value of compliance data. AI can not only accelerate assessment and identify risks but can also alert teams to issues that might be difficult to identify manually. Advanced algorithms, often trained on your specific historical data and best practices, can generate profound and actionable insights throughout the product development lifecycle.

Machine learning technology supports proactive risk mitigation by detecting patterns and trends that can predict regulatory or supply chain issues. This data is then validated by human experts for accuracy and contextual meaning, facilitating proactive engagement with regulatory bodies for official guidance on their interpretation.

AI has the ability to generate trend insights in relation to specific ingredients, applications, and consumer sentiment, helping manufacturers to better understand their market and leverage this understanding to gain competitiveness. This technology can also simulate and scenario test virtual formulations, accelerating development and supporting successful launches. By adopting an expertise-augmented approach, organizations can achieve better insight quality and forecasting than either human experts or AI can achieve in isolation.

Organizational Evolution through Compliant Design

With the evolution of the food and beverage industry progressing at an unprecedented pace, embracing innovative approaches to product development is key for both competitive advantage and consumer trust. Compliant design is transformative, modernizing product development lifecycles by providing relevant insights to the right people at each stage, identifying issues faster, and supporting more effective and decision making. Compliant design not only accelerates innovation but also establishes product stability and compliance in a changing regulatory landscape.

By shifting left and breaking down silos, manufacturers can streamline processes while leveraging the combined power of AI and human expertise, achieving greater efficiency and value. The future of the industry belongs to those who can adapt, innovate, and respond swiftly to the complex challenges it presents.

Frierson is vice president of digital solutions at FoodChain ID, a Fairfield, Iowa-based firm that provides expertise and technology-driven services to support the food industry. Reach him at wes.frierson@foodchainid.com.

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The Arizona House Committee on Land, Agriculture and Rural Affairs voted 6-3 in favor of making it illegal to label any product grown in a laboratory “meat” or “poultry.” House Bill 2244, introduced by Rep. Quang Nguyen (R) on January 22, if enacted, would make prohibit use of any term that is “the same or deceptively similar” to meat or poultry. The lawmakers say the legislation would prevent consumer confusion. The measure now needs approval of the state’s full House.

Challengers of the proposed legislation argue that FDA already requires any meat product produced in a laboratory to be labeled a “cell cultured’’ or “cell cultivated’’ product, so consumers shouldn’t be confused.

A second proposed piece of legislation, House Bill 2121 introduced by Rep. David Marshall (R), aims to prohibit the sale or production of cell-cultured animal products for human or animal consumption. An early version of the legislation sought to impose civil penalties on anyone who offers to sell, sells, or produces a cell-cultured animal product for human or animal consumption, and would create a cause of action for anyone or any company or organization, whose business is adversely affected by a violation of the prohibition.

Last June, FDA approved the sale of cultivated chicken in the United States. While Arizona is the first state in the U.S. to consider a ban on lab-grown meats, in November 2023, Italy outlawed all cultured proteins. If the Arizona bill passes, industry experts expect to see similar bills in additional states.

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FDA has proposed revoking the regulation that authorizes the use of brominated vegetable oil (BVO) in food due to concerns about harm to human health. The proposal comes on the heels of a California law that went into effect last month that banned four food ingredients, including BVO.

In 1958, FDA classified BVO as generally recognized as safe (GRAS), permitting its use as a food-grade ingredient; however, in 1970, the agency removed it from the codified list of GRAS substances and regulated it as a food additive. Opponents of that rule have argued that BVO in beverages poses a harmful risk to human health, citing thyroid and chronic health problems that have resulted from exposure.

FDA made the current proposed ban after conducting a 90-day dietary exposure study in rats, which concluded that, at high doses, exposure to BVO resulted in thyroid damage in the animals. “Based on these data and remaining unresolved safety questions, the FDA can no longer conclude that the use of BVO in food is safe,” the agency said in a statement published November 2.

Other countries, such as those in the European Union, Japan, and the U.K. have already banned BVO use in food. Many U.S. food manufacturers have also stopped using the substance and today, few beverages in the U.S. contain the ingredient.

The Institute of Food Technologists was pleased with the proposed ban. “We applaud FDA’s evidence-based assessment of food additive safety, as we believe science is critical for establishing policies to ensure a global food system that is sustainable, safe, nutritious, and accessible to all,” a spokesperson for the organization told Food Quality & Safety. “We look forward to seeing the continued evolution of the Human Foods Program.”

The proposed rule will be available for public comment for 75 days, and all comments should be submitted by January 17, 2024, at regulations.gov.

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The European Commission has released significantly stricter limits for the use of nitrites and nitrates as food additives.

The new limits amend annexes to Commission Regulation (EU) 1333/2008 of the European Parliament and Council, and to Commission Regulation (EU) 231/2012 regarding nitrites (E 249-250) and nitrates (E 251-252).

Nitrites and nitrates are often used in processed meats, cheeses, and other foods due to their antimicrobial properties. The new regulations are aimed at reducing consumer exposure to these substances while also protecting against foodborne pathogens such as Listeria, Salmonella, and Clostridium botulinum.

The updated limits also take into account the diversity of products and their manufacturing conditions across the EU, according to the Commission.

Food business operators within the European Union now have two years to adapt and comply with the new nitrate limits. Visit the Commission’s report for more information on the limits for specific foods.

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