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Infographic on Intellectual Property framework in plant biotechnology. Fostering innovation: Why an effective intellectual property framework is needed for plant biotechnology to flourish.
DownloadOn 18 January 2023, EFSA (European Food Safety Authority) published the updated Guidance on the assessment of exposure of operators, workers, residents and bystanders in risk assessment of plant protection products (PPPs).
Together with the guidance document, EFSA has also developed an online calculator for the purpose of estimating the non-dietary human exposure related to the use of PPPs. However, acknowledging the well-known limitations of the online tool, CropLife Europe (CLE) has developed an offline MS Excel-based calculator, which risk assessors will recognize as a familiar tool similar to the one available with the previous EFSA Guidance from 2014. This offline tool is made available for risk assessors of PPPs to aid them in the assessment of substances used in PPPs in the context of plant protection products regulation according to EFSA Guidance 2022.
The tool has been subjected to thorough testing; however, CLE does not guarantee that the tool works error-free. CLE offers no warranty either to the reliability of the tool and the provided information or to the conclusions or assumptions made by any user on the basis of the use of this tool or the use of such information or to the regulatory acceptance of the assessments conducted using the tool. All usage is at the discretion of the user and CLE is not liable for any consequences resulting from such use.
Before using this calculator, the user should make sure that the latest version is being used.
DownloadExposure to skin sensitizers is common and regulated in many industry sectors. For cosmetics, a risk-based approach has been implemented, focused on preventing the induction of sensitization. First, a No Expected Sensitization Induction Level (NESIL) is derived, then modified by Sensitization Assessment Factors (SAFs) to derive an Acceptable Exposure Level (AEL). The AEL is used in risk assessment, being compared with an esti- mated exposure dose, specific to the exposure scenario. Since in Europe there is increased concern regarding exposure towards potentially sensitizing pesticides via spray drift, we explore how existing practice can be modified to allow Quantitative Risk Assessment (QRA) of pesticides for bystanders and residents. NESIL deri- vation by the Local Lymph Node Assay (LLNA), the globally required in vivo assay for this endpoint, is reviewed alongside consideration of appropriate SAFs. Using a case study, the principle that the NESIL in μg/cm2 can be derived by multiplying LLNA EC3% figure by a factor of 250 is adopted. The NESIL is then reduced by an overall SAF of 25 to establish an exposure level below which there is minimal bystander and resident risk. Whilst this paper focuses on European risk assessment and management, the approach is generic and universally applicable.
Key highlights of this paper:
- An extensive H295R database from various stakeholders has been analyzed.
- Quality control acceptance criteria are not consistently achieved.
- Pairwise significance testing contributes to the assay’s high positive hit rate.
- Trend testing and/or 1.5-fold change threshold reduce the rate of positive outcomes.
- Improving H295R data interpretation could help refine any subsequent testing needs.
The H295R steroidogenesis assay, performed according to OECD Test Guideline (TG) 456, is an important component of the Level 2 (in vitro) battery of assays in the OECD Conceptual Framework for Testing and Assessment of ED for evaluating endocrine mechanisms. The assay can inform on the potential of a chemical to interfere with the synthesis and metabolism of steroid hormones, in particular testosterone and estradiol.
An extensive analysis of a large compendium of H295R data has been conducted to addressthe observation by several stakeholders of an unusually high occurrence of positive outcomes, especially those of low efficacy, but nonetheless statistically significant, outcomes in the assay. The database consisted of OECD TG 456 guideline studies provided by 11 agrochemical companies and comprised of ~16,800 raw data entries, of which ~9,900 represented data for 50 test articles, and ~7,000 represented quality control (reference compound) data. The data were analysed using 4 different approaches: 1: analysis of pairwise concentration-specific significance compared to plate-matched vehicle controls (as per the guideline of 2011); 2: inclusion of a non-parametric Jonckheere-Terpstra trend statistic to confirm significant concentration-response trend across testing concentrations; 3:consideration of a 1.5-fold threshold for hormone changes prior to using the guideline statistics (as per the recently refined guideline, 2022); 4: integration of all three of the evaluated parameters in combination.
The highest number of positive interpretations for individual runs and overall assay outcomes was observed when using the pairwise comparison of OECD TG 456 (2011). The integration of either trend testing or consideration of the 1.5-fold change cut-off markedly reduced the number of positive interpretations. The number of final call outcomes for which no conclusion could be obtained was also improved using the additional criteria. Overall, theanalyses confirmed that the addition of efficacy cut-off and, to a lesser extent, trend testing criteria to the existing statistical evaluation can help reduce equivocal outcomes and identifyrobust positive calls in the H295R assay that are appropriate for decision making within a regulatory context.
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- The Commission’s proposal on New Genomic Techniques (NGTs) has the potential to enable all actors, including SMEs and public researchers, to bring more resilient and sustainable plants to the EU market. This supports investment in plant breeding innovation in the EU and enhances competitiveness and sustainability of European agriculture.
- An enabling EU framework must provide clear and science-based criteria to determine the equivalence between NGT-derived plants and their conventional counterparts; a simplified verification process allowing all actors to commercialise products; and proportionate authorisation requirements, especially for products for which a detection method cannot be developed.
- The European agricultural sector urgently needs a proportionate and science-based regulation on NGTs. Allowing their uptake in the EU will facilitate the transition towards a more sustainable and resilient agriculture. Achieving this requires swift action from the European Parliament and Council.
Seed treatment with conventional plant protection products and/or biological products is a targeted, one-time, precision application technique that has a low environmental footprint and can contribute towards the EU Green Deal and Farm to Fork objectives.
Based on the known presence of pests and pathogens in the field, seed treatment is an important component of Integrated Pest Management (IPM).
Growers have the choice to use treated seeds in their fields. Seeds are either purchased already treated or are treated on farm.
We believe that it is implicit in the relevant legal provisions that information submitted to EFSA by applicants, as part of the authorisation procedure for GM, must be relevant to the risk assessment. The terms of Articles 9(3) and 21(3) of Regulation (EC) No 1829/2003 on genetically modified food and feed (“Regulation 1829/2003”) do not require all available information (irrespective of its significance) to be submitted.