Search Results (14)

Traditional animal-based preclinical models, including xenografts and genetically engineered mice, have been used for assessing pharmacodynamics, toxicity, efficacy, and safety for decades. Despite their limited ability to mimic human tumor heterogeneity, immune interactions, and microenvironmental complexity, over 90% of oncology candidates that succeed in animal studies fail in clinical trials. The New Approach Methodologies (NAMs), which include patient-derived organoids, organ-on-chip platforms, and AI-driven computational models, provide human-relevant solutions that can improve predictive validity, mechanistic insight, and ethics. Through these technologies, it will be possible to replicate tumor biology specific to patients, to support co-clinical trial designs, and to facilitate biomarker discovery while reducing animal testing. Several recent regulatory reforms, including the Food and Drug Administration (FDA) Modernization Act 2.0 and the European Medicines Agency’s NAM qualification framework, have established clear pathways for the integration of validated NAMs into preclinical drug evaluation. Critically evaluating the scientific rationale, comparative performance, and regulatory context of key NAM platforms in oncology, this review highlights opportunities for synergistic integration, technical refinement, and global harmonization in order to accelerate the development of clinically effective cancer therapeutics based on preclinical findings. Full article

Beeswax is widely used in apiculture and can accumulate neonicotinoid residues due to the intensive use of systemic pesticides in agriculture. These contaminants pose potential risks to honeybee health and may indirectly affect the quality and safety of hive products such as honey, pollen, and royal jelly. This study evaluates several decontamination methods for neonicotinoid removal from contaminated beeswax, including modern techniques (microwaves, ultrasonic baths, and magnetic stirring with heating) and conventional approaches based on heat, agitation, and water—either pure or acidified. Among these, the traditional method that uses an aqueous oxalic acid solution proved highly effective, removing over 99% of neonicotinoid residues after two treatment cycles, even at wax quantities up to 200 g. The treatment also improved the colour and physical properties of the wax and was well tolerated by bees, according to a qualitative acceptance test. The simplicity, low cost, and absence of hazardous by-products make this method suitable for scale-up and adoption in real apicultural practices. These findings support the development of accessible and sustainable strategies for the decontamination of wax matrices that may otherwise act as long-term reservoirs of pesticide residues in the food chain. Full article

The malicious contamination of food has been recognized by the World Health Organization (WHO) as a real and current threat that must be integrated into food safety systems to ensure preparedness for deliberate attacks. Traditional approaches, such as HACCP, effectively address unintentional hazards but remain insufficient against intentional contamination and sabotage. Food defense frameworks such as HACCP (Hazard Analysis and Critical Control Points), VACCP (Vulnerability Assessment and Critical Control Points), and TACCP (Threat Assessment and Critical Control Points) represent complementary methodologies, addressing unintentional, economically motivated, and deliberate threats, respectively. This review critically examines food defense frameworks across the European Union, the United States, and the United Kingdom, as well as standards benchmarked by the Global Food Safety Initiative (GFSI), drawing on peer-reviewed and grey literature sources. In the United States, the Food Safety Modernization Act (FSMA) mandates the development and periodic reassessment of food defense plans, while the European Union primarily relies on general food law and voluntary certification schemes. The United Kingdom’s PAS 96:2017 standard provides TACCP-based guidance that also acknowledges cybercrime as a deliberate threat. Building on these regulatory and operational gaps, this paper proposes the Cyber-FSMS model, an integrated framework that combines traditional food defense pillars with cyber risk management to address cyber–physical vulnerabilities in increasingly digitalized supply chains. The model introduces six interconnected components (governance, vulnerability assessment, mitigation, monitoring, verification, and recovery) designed to embed cyber-resilience into Food Safety Management Systems (FSMS). Priority actions include regulatory harmonization, practical support for small and medium-sized enterprises (SMEs), and the alignment of cyber-resilience principles with upcoming GFSI benchmarking developments, thereby strengthening the integrity, robustness, and adaptability of global food supply chains. Full article

As vital outcomes of agricultural technological innovation, new animal breeds are not only foundational to rural revitalization but also central to preserving ecological diversity. At present, China lacks a clear and coherent legal framework of protection for new animal breeds, making it difficult to accommodate practical demands posed by modern breeding technologies such as gene editing. The results show that international models for protecting intellectual property in new animal breeds generally fall into three categories: granting patents for animal breeds, granting patents for breeding methods, and establishing sui generis rights for animal breeds. The sui generis protecting model of animal breed rights provides stronger protection and better reflects genetic specificity of such breeds. This research recommends that, on ethical review, stricter oversight of animal welfare and genetic data usage should be implemented to promote responsible innovation. On safety assessment, detailed standards should be developed for food and environmental risk assessment to ensure biodiversity and ecological sustainability. On risk balance evaluation, efforts should be made to ensure effective alignment among animal breed rights, animal welfare, and fair competition in the market, while also striking an appropriate balance of interests between breeders and other stakeholders such as farmers, who act as conservers and providers of germplasm resources. Full article

Antimicrobial food packaging is considered a promising technology to improve food safety by inhibiting or reducing the growth of food microorganisms and minimizing the need for preservatives. This study aimed to develop and evaluate carboxymethyl cellulose (CMC) films integrated with bacteriocins for antibacterial efficacy. Plantaricin W was assessed as a potential bacteriocin for activation of CMC to control the dangerous food-borne pathogen, Listeria monocytogenes. Minced beef samples were inoculated with L. monocytogenes ATCC BAA-679 and treated with plantaricin W-activated food packaging. The results showed a significant reduction of the target pathogen by approximately 1 log cycle compared to the control group. Enterocin F4-9 is a novel bacteriocin that acts on Gram-negative microbes that were not affected by plantaricin W. Therefore, a novel food packaging activated with plantaricin W and enterocin F4-9 was developed to broaden their antimicrobial activity. The effect of this film on meat-associated microbes was investigated. The results demonstrated that the film significantly reduced the counts of mesophilic and psychotropic bacteria by 86.67% and 96.67%, respectively. Additionally, the pH values of the treated meat samples were significantly lower than those of the untreated controls. The obtained findings indicated that bacteriocin-activated CMC films could potentially be utilized as antimicrobial packaging in modern food technology. Full article

Water plays a critical role in the growth and management of fresh produce, being a vital resource and a potential vector for pathogens. To address these concerns, guidelines for the microbiological quality of treated wastewater, recreational, irrigation, and drinking water have been established worldwide. With multiple outbreaks linked to Escherichia coli (E. coli) contamination, monitoring and improving water quality standards have become essential, especially for small-scale and limited-resource farmers. The Food Safety and Modernization Act (FSMA, 2014) in the United States was introduced to regulate microbiological safety of produce, focusing on irrigation water. Approximately 77% of farmers in Kentucky are small farmers, of which, 4.2% supply directly to consumers through various avenues, accounting for approximately USD 24 million a year. This study examined the microbial quality of irrigation water used in Kentucky, focusing on the presence and number of coliform bacteria and E. coli. The report covers findings from a year-long program providing free microbial water quality testing to producers (n = 90), analyzing groundwater and surface water samples (n = 296). Results indicate surface water showing a significantly higher risk of exceeding FSMA thresholds. The findings emphasize the need for continued outreach, education, and accessible testing resources to support compliance with evolving Produce Safety Rule regulations, especially among small-scale producers. Full article

Modern agriculture is currently enduring rapid changes in defiance of the continuing increase of the global population and the various consequent environmental challenges. Crop quality is becoming as important as crop yield and can be characterized by several parameters. Extensive use of chemical fertilizers leads to food safety concerns globally; hence, the use of mycorrhizal symbionts have proven to be beneficial for the sustainable growth of the agricultural cropping system. Microflora inhabiting the soil entails various ecological interactions which are associated with agricultural performances. Amongst these microflora, mycorrhizal fungi are the critical suppliers of nutrients, with restricted diffusion capacities of minerals such as phosphorus, nitrate, zinc, sulfur etc. Mycorrhizae are the obligatory biotrophs that depend upon their host plant for the nutritional requirements. They act as the key contributors to sustainable agro-ecological enforcement and impact globally on the eco-systemic processes. These soil inhabitants devote themselves to the continuous nutrient flow and extemporize resistance against various environmental stresses like drought, flood, metal toxicity, salinity, etc. This review briefly highlights the taxonomic co-evolution, factors affecting mycorrhizal behaviors (phytohormonal regulation), and the concise mechanistic approach (improved water status, photosystems, stomatal conductance, ionic uptake, C & N fixation) to combat various environmental stresses (biotic/abiotic). Plant growth regulators play a crucial role in this symbiotic establishment with the plant roots. Auxins, brassinosteroids, and strigolactones are responsible for the establishment of mycorrhizal association. On the other hand, ethylene, abscisic acid, and jasmonic acids can promote or downregulate this process in the plants. Whereas, gibberellic acids and salicylic acids negatively impact on mycorrhizal association. The hormonal homeostasis (in response to fungal associations) leads to the activation of transcriptional and signaling cascades which ensues various physio-morphological changes for the benefit of the plant. The role of phytohormones in the regulation of plant-fungus mutualism, and the impact of mycorrhization on the activation of molecular and transcriptional cascades, have been described along with the potential applications of agricultural produce and soil rehabilitation. Full article

Food safety is a major risk for agribusiness firms. According to the Centers for Disease Control and Prevention (CDC), approximately 5000 people die annually, and 36,000 people are hospitalized as a result of foodborne outbreaks in the United States. Globally, the death estimate is about 42,000 people per year. A single outbreak could cost a particular segment of the food industry hundreds of millions of dollars due to recalls and liability; these instances might amount to billions of dollars annually. Despite U.S. advancements and regulations, such as pathogen reduction/hazard analysis critical control points (PR/HACCP) in 1996 and the Food Modernization Act in 2010, to reduce food-safety risk, retail meat facilities continue to experience recalls and major outbreaks. We developed a stochastic-optimization framework and used stochastic-dominance methods to evaluate the effectiveness for three strategies that are used by retail meat facilities. Copula value-at-risk (CVaR) was utilized to predict the magnitude of the risk exposure associated with alternative, cost-effective risk-reduction strategies. The results showed that optimal retail-intervention strategies vary by meat and pathogen types, and that having a single Salmonella performance standard for PR/HACCP could be inefficient for reducing other pathogens and food-safety risks. Full article

Obesity and type 2 diabetes mellitus have become a significant public health problem in the past decades. Their prevalence is increasing worldwide each year, greatly impacting the economic and personal aspects, mainly because they frequently coexist, where the term “diabesity” may be used. The drug class of glucagon-like peptide 1 receptor agonists (GLP-1 RAs) is one of the most modern therapy options in managing these metabolic disorders. This review focuses on the effects of liraglutide, a long-acting GLP-1 RA, in diabesity and non-diabetic excess weight. This drug class improves glycemic control by enhancing insulin secretion from the beta-pancreatic cells and inhibiting glucagon release. Furthermore, other effects include slowing gastric emptying, increasing postprandial satiety, and reducing the appetite and food consumption by influencing the central nervous system, with weight reduction effects. It also reduces cardiovascular events and has positive effects on blood pressure and lipid profile. A lower-dose liraglutide (1.2 or 1.8 mg/day) is used in patients with diabetes, while the higher dose (3.0 mg/day) is approved as an anti-obesity drug. In this review, we have summarized the role of liraglutide in clinical practice, highlighting its safety and efficacy as a glucose-lowering agent and a weight-reduction drug in patients with and without diabetes. Full article

Current study investigated effects of elevated hydrostatic pressure exposure in the presence of mild heat and natural antimicrobials against Staphylococcus aureus. Hydrostatic pressure of 350 to 550 MPa with nisin (5000 IU/mL), carvacrol, or caprylic acid (0.5% v/v) were applied for the reduction in four-strain mixture of S. aureus in HEPES buffer at 4 and 40 °C for up to 7 min. Results were statistically analyzed by ANOVA and D-values were additionally calculated using best-fitted linear model. Prior to exposure to treatments at 4 °C, counts of the pathogen were 7.95 ± 0.4 log CFU/mL and were reduced (p < 0.05) to 6.44 ± 0.3 log CFU/mL after 7 min of treatment at 450 MPa. D-value associated with this treatment was 5.34 min (R² = 0.72). At 40 °C, counts were 8.21 ± 0.7 and 5.77 ± 0.3 log CFU/mL before and after the 7-min treatments, respectively. D-value associated with 40 °C treatment was 3.30 min (R² = 0.62). Application of the antimicrobials provided additional pathogen reduction augmentation for treatments < 5 min. The results of the current study could be incorporated for meeting regulatory requirements such as Food Code, HACCP, and Preventive Control for Human Food of Food Safety Modernization Act for assuring microbiological safety of products against this prevalent pathogen of public health concern. Full article

After almost 40 years, the 27 member states (MS) of the European Union (EU) will comply with the European Law 429/2016 in 2021 by completing a process of unification and harmonization of all regulations related to animal health between MS. These new provisions are based on modern scientific principles on animal health, on long-term epidemiological data, and, above all, on the most current risk assessment and analysis. The paper describes all changes and updates, which will impact the Italian current National regulation. A total of 58 animal diseases have been included in the Annex II (“Listing”) and Annex IV (“Categorization”) of the new Delegated Act (DA 2018/1629). Five diseases comprising the great viral epizooties were automatically included on the list because of their primary importance. These diseases include foot and mouth disease (FMD), African swine fever (ASF), classical swine fever (CSF), highly pathogenic avian influenza (HPAI), and African horse sickness (AHS). Another 53 diseases have been identified by the ad hoc assessment on listing and categorization of animal diseases developed by the European Food Safety Association. Seventeen communicable diseases of the Order Artiodactlya (sheep, goats, deer, etc.) have been listed including foot and mouth disease, sheep and goat pox, and pestes de petits ruminants. In addition, other endemic diseases affecting more than one species include blue tongue, tuberculosis, brucellosis, and anthrax. There are five categories (A-E) based on the degree of action to be undertaken throughout the EU for each disease. These vary from complete eradication for diseases not normally found in the EU like FMD (category A) for establishing surveillance for diseases like West Nile that present high risk but lack control tools (category E). Full article

Since the historic outbreak near Broad Street in London, which serves as cornerstone of modern epidemiology, infectious diseases spread in surface and sub-surface water has been a persisting public health challenge. The current study investigated persistence of wild-type and pressure-stressed Listeria monocytogenes, Escherichia coli O157:H7, and non-typhoidal Salmonella enterica serovars in surface water stored aerobically for up to 28 days at 5, 25, and 37 °C. Additionally, biofilm formation of wild-type and pressure-stressed non-typhoidal Salmonella serovars were monitored on surface of stainless steel and rubber coupons for 28 days at 25 and 37 °C. While L. monocytogenes exhibited a lower (p < 0.05) survival rate at 5 °C, relative to the two Gram-negative pathogens, at higher temperatures of 25 and 37 °C, all three pathogens exhibited similar (p ≥ 0.05) trends for survival in surface water. Both wild-type and pressure-stressed Salmonella serovars in the vast majority of tested times, temperatures, and surfaces exhibited comparable (p ≥ 0.05) persistence and biofilm formation capability. Our study thus indicates the occurrence of contamination could lead to prolonged survival of these microorganisms in low-nutrient environments and highlights the need for preventive measures such as those articulated under Produce Safety Rule of the U.S. Food Safety Modernization Act. Full article

Agricultural water is a known vector for the transfer of foodborne pathogens onto fresh produce. Development of pre-harvest and post-harvest microbial profiles of agricultural water used by fresh produce growers, processors, and holdings is a requirement under the Food Safety Modernization Act Produce Safety Rule. One of the United States Environmental Protection Agency (US EPA) approved agricultural water testing methods is US EPA Method 1603, which requires no greater than a 6-h time frame between the collection of the water sample and initiation of analysis. This 6-h timeframe is unrealistic for many produce growers due to there being few laboratories certified to conduct testing and the geographic location of the farms. Agricultural water samples (n = 101) from well water and surface water were collected from 60 different farms to determine if holding samples for 24 h yielded significantly more generic Escherichia coli (E.coli) than 6 h using EPA 1603 method. A total of 32 samples were found contaminated with generic E. coli. Of these positive samples, surface water accounted for 87.5% of the samples (n = 28). There was no significant disparity between populations of generic E. coli at 6- and 24-h sample-test time interval (p > 0.05). These results provide evidence that the sample-test time interval can be extended to 24-h time, which makes quantitative generic E. coli testing for agricultural water as mandated by the FSMA Produce Safety Rule more accessible to growers. Full article

Food safety standards are a necessity to protect consumers’ health in today’s growing global food trade. A number of studies have suggested safety standards can interrupt trade, bringing financial and technical burdens on small as well as large agri-food producers in developing countries. Other examples have shown that economical extension, key intermediaries, and funded initiatives have substantially enhanced the capacities of growers in some countries of the Middle East and North Africa (MENA) region to meet the food safety and quality requirements, and improve their access to international markets. These endeavors often compensate for the weak regulatory framework, but do not offer a sustainable solution. There is a big gap in the food safety level and control systems between countries in the MENA region and those in the developed nations. This certainly has implications for the safety of fresh produce and agricultural practices, which hinders any progress in their international food trade. To overcome the barriers of legal and private standards, food safety should be a national priority for sustainable agricultural development in the MENA countries. Local governments have a primary role in adopting the vision for developing and facilitating the implementation of their national Good Agricultural Practices (GAP) standards that are consistent with the international requirements and adapted to local policies and environment. Together, the public and private sector’s support are instrumental to deliver the skills and infrastructure needed for leveraging the safety and quality level of the agri-food chain. Full article