Policy masquerading as science: an examination of non-state actor involvement in European risk assessment policy for genetically modified animals

In 2013, at the request of the European Commission, the European Food Safety Authority (EFSA) announced a new risk assessment policy: Guidance on the environmental risks of genetically modified (GM) animals (‘Guidance’). This policy specifies the issues to be addressed in future risk assessments for GM animals. EFSA is the European Commission's scientific arm, responsible for food-related risk assessment. EFSA relies heavily on independent experts and consults non-state actors. Employing expert interviews and documentary analysis, the article explores non-state actor involvement in a traditionally expert domain through a case study. Analysis of EFSA's consultation demonstrates the inability of non-state actors to influence policy. The article argues that despite international legal obligations to develop risk assessment policy, the European Commission failed to recognize the Guidance as policy. When policy masquerades as science, unjustified restrictions are placed on non-state actor involvement and value judgements are cloaked from public scrutiny

Thresholds of Toxicological Concern for Cosmetics-Related Substances: New Database, Thresholds, and Enrichment of Chemical Space

A new dataset of cosmetics-related chemicals for the Threshold of Toxicological Concern (TTC) approach has been compiled, comprising 552 chemicals with 219, 40, and 293 chemicals in Cramer Classes I, II, and III, respectively. Data were integrated and curated to create a database of No-/Lowest-Observed-Adverse-Effect Level (NOAEL/LOAEL) values, from which the final COSMOS TTC dataset was developed. Criteria for study inclusion and NOAEL decisions were defined, and rigorous quality control was performed for study details and assignment of Cramer classes. From the final COSMOS TTC dataset, human exposure thresholds of 42 and 7.9 μg/kg-bw/day were derived for Cramer Classes I and III, respectively. The size of Cramer Class II was insufficient for derivation of a TTC value. The COSMOS TTC dataset was then federated with the dataset of Munro and colleagues, previously published in 1996, after updating the latter using the quality control processes for this project. This federated dataset expands the chemical space and provides more robust thresholds. The 966 substances in the federated database comprise 245, 49 and 672 chemicals in Cramer Classes I, II and III, respectively. The corresponding TTC values of 46, 6.2 and 2.3 μg/kg-bw/day are broadly similar to those of the original Munro dataset

EFSA BIOHAZ Panel (EFSA Panel on Biologicial Hazards), 2013. Scientific Opinion on the public health hazards to be covered by inspection of meat (solipeds)

A risk ranking process identified Trichinella spp. as the most relevant biological hazard in the context of meat inspection of domestic solipeds. Without a full and reliable soliped traceability system, it is considered that either testing all slaughtered solipeds for Trichinella spp., or inactivation meat treatments (heat or irradiation) should be used to maintain the current level of safety. With regard to general aspects of current meat inspection practices, the use of manual techniques during current post-mortem soliped meat inspection may increase microbial cross-contamination, and is considered to have a detrimental effect on the microbiological status of soliped carcass meat. Therefore, the use of visual-only inspection is suggested for “non-suspect” solipeds. For chemical hazards, phenylbutazone and cadmium were ranked as being of high potential concern. Monitoring programmes for chemical hazards should be more flexible and based on the risk of occurrence, taking into account Food Chain Information (FCI), covering the specific on-farm environmental conditions and individual animal treatments, and the ranking of chemical substances, which should be regularly updated and include new hazards. Sampling, testing and intervention protocols for chemical hazards should be better integrated and should focus particularly on cadmium, phenylbutazone and priority “essential substances” approved for treatment of equine animals. Implementation and enforcement of a more robust and reliable identification system throughout the European Union is needed to improve traceability of domestic solipeds. Meat inspection is recognised as a valuable tool for surveillance and monitoring of animal health and welfare conditions. If visual only post-mortem inspection is implemented for routine slaughter, a reduction in the detection of strangles and mild cases of rhodococcosis would occur. However, this was considered unlikely to affect the overall surveillance of both diseases. Improvement of FCI and traceability were considered as not having a negative effect on animal health and welfare surveillance

Dietary supplementation with ferric tyrosine improves zootechnical performance and reduces caecal Campylobacter spp. load in poultry

The objective of this study was to evaluate the effect of ferric tyrosine on the reduction of Campylobacter spp. and zootechnical performance in broilers exposed to Campylobacter spp. using a natural challenge model to simulate commercial conditions. Additionally, the minimum inhibitory concentrations (MIC) of ferric tyrosine against common enteropathogens were evaluated. On day 0, 840 healthy male day-old birds (Ross 308) were randomly allocated to 6 replicate pens of 35 birds and fed diets containing different concentrations of ferric tyrosine (0, 0.02, 0.05 and 0.2 g/kg) in mash form for 42 days. Overall, broilers fed diets containing ferric tyrosine showed significantly improved body weight at day 42 and weight gain compared to the control group. However, birds fed ferric tyrosine ate significantly more than the control birds so significant improvements in FCR were not observed. Microbiological analyses of caecal samples collected on day 42 of the study showed, per gram sample, 2-3 log10 reduction in Campylobacter spp. and 1 log10 reduction in Escherichia coli in the groups fed diets containing ferric tyrosine compared to the control and Salmonella enterica, indicating that ferric tyrosine does not exert antimicrobial activity. Collectively, these results show that birds fed ferric tyrosine grew faster and consumed more feed compared to the control birds indicating potential benefits of faster attainment of slaughter weight with no significant reduction on feed efficiency. Moreover, ferric tyrosine significantly reduces caecal Campylobacter spp. and E. coli indicating potential as a non-antibiotic feed additive to lower the risk of Campylobacter infections transmitted through the food chain

Veterinary Medicine Needs New Green Antimicrobial Drugs

Given that: (1) the worldwide consumption of antimicrobial drugs (AMDs) used in food-producing animals will increase over the coming decades; (2) the prudent use of AMDs will not suffice to stem the rise in human antimicrobial resistance (AMR) of animal origin; (3) alternatives to AMD use are not available or not implementable, there is an urgent need to develop novel AMDs for food-producing animals. This is not for animal health reasons, but to break the link between human and animal resistomes. In this review we establish the feasibility of developing for veterinary medicine new AMDs, termed green antibiotics, having minimal ecological impact on the animal commensal and environmental microbiomes.We first explain why animal and human commensal microbiota comprise a turnstile exchange, between the human and animal resistomes. We then outline the ideal physico-chemical, pharmacokinetic and pharmacodynamic properties of a veterinary green antibiotic and conclude that they can be developed through a rational screening of currently used AMD classes. The ideal drug will be hydrophilic, of relatively low potency, slow clearance and small volume of distribution. It should be eliminated principally by the kidney as inactive metabolite(s). For oral administration, bioavailability can be enhanced by developing lipophilic pro-drugs. For parenteral administration, slow-release formulations of existing eco-friendly AMDs with a short elimination half-life can be developed. These new eco-friendly veterinary AMDs can be developed from currently used drug classes to provide alternative agents to those currently used in veterinary medicine and mitigate animal contributions to the human AMR problem

Scientific Opinion on the public health hazards to be covered by inspection of meat from farmed game

Salmonella spp. in farmed wild boar and Toxoplasma gondii in farmed deer and farmed wild boar were ranked as a high priority for meat inspection. Trichinella spp. in wild boar was ranked as low priority due to current controls, which should be continued. For chemical hazards, all substances were ranked as medium or lower potential concern. More effective control of biological hazards could be achieved using an integrated farm to chilled carcass approach, including improved food chain information (FCI) and risk-based controls. Further studies are required on Salmonella spp. in farmed wild boar and T. gondii in farmed wild boar and farmed deer. If new information confirms a high risk to public health from meat from these species, setting targets at carcass level should be considered. Palpation and incision should be omitted, as it will not detect biological hazards considered to be a high priority for meat inspection while increasing the potential spread and cross-contamination of the carcasses with Salmonella. Palpation and/or incision may be applied where abnormalities have been detected but away from the slaughter line. However the elimination of routine palpation and incision would be detrimental for detecting tuberculosis. As farmed deer and farmed wild boar can act as tuberculosis reservoirs, any reduction in the detection, due to changes in the post-mortem inspection procedures, will have consequences for the overall surveillance of tuberculosis. Monitoring programmes for chemical hazards should be more flexible and based on the risk of occurrence, taking into account FCI, which should be expanded to reflect the specific environmental conditions of the farms where the animals are reared, and the ranking of chemical substances, which should be regularly updated and include new hazards. Control programmes across the food chain, national residue control programmes, feed control and monitoring of environmental contaminants should be better integrated