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EFSA Guidance Document for predicting environmental concentrations of active substances of plant protection products and transformation products of these active substances in soil: This guidance published on 19 October 2017 replaces the earlier version published on 28 April 2015.

ABSTRACT: This EFSA Guidance Document provides guidance for the exposure assessment of soil organisms to plant protection products (PPPs) and their transformation products in accordance with Regulation (EC) No. 1107/20091 of the European Parliament and the Council. This guidance was produced by EFSA in response to a question posed by the European Commission according to Article 31 of Regulation (EC) No. 178/20022 of the European Parliament and of the Council. Guidance is provided for all types of concentrations that are potentially needed for assessing ecotoxicological effects, i.e. the concentration in total soil and the concentration in pore water, both averaged over various depths and time windows. The current guidance considers both permanent crops and annual crops. The recommended exposure-assessment procedure consists of four tiers. To facilitate efficient use of the tiered approach in regulatory practice, user-friendly software tools have been developed. In higher tiers of the exposure assessment, crop interception and subsequent dissipation at the crop canopy may be included. The models that simulate these processes were harmonised. In addition, easy-to-use tables for the fraction of the dose intercepted by the canopy that is washed off have been developed, which should be used in combination with the simple analytical model. With respect to substance-specific model inputs, this guidance generally follows earlier documents; however, new guidance is included for some specific substance parameters.

SUBMITTER: European Food Safety Authority

PROVIDER: S-EPMC7010114 | biostudies-literature | 2017 Oct

REPOSITORIES: biostudies-literature

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EFSA Guidance Document for predicting environmental concentrations of active substances of plant protection products and transformation products of these active substances in soil: This guidance published on 19 October 2017 replaces the earlier version published on 28 April 2015.

EFSA journal. European Food Safety Authority 20171019 10

This EFSA Guidance Document provides guidance for the exposure assessment of soil organisms to plant protection products (PPPs) and their transformation products in accordance with Regulation (EC) No. 1107/2009<sup>1</sup> of the European Parliament and the Council. This guidance was produced by EFSA in response to a question posed by the European Commission according to Article 31 of Regulation (EC) No. 178/2002<sup>2</sup> of the European Parliament and of the Council. Guidance is provided for ...[more]

PMID: 32625283

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Project description:EFSA Strategy 2027 outlines the need for fit-for-purpose protocols for EFSA generic scientific assessments to aid in delivering trustworthy scientific advice. This EFSA Scientific Committee guidance document helps address this need by providing a harmonised and flexible framework for developing protocols for EFSA generic assessments. The guidance replaces the 'Draft framework for protocol development for EFSA's scientific assessments' published in 2020. The two main steps in protocol development are described. The first is problem formulation, which illustrates the objectives of the assessment. Here a new approach to translating the mandated Terms of Reference into scientifically answerable assessment questions and sub-questions is proposed: the 'APRIO' paradigm (Agent, Pathway, Receptor, Intervention and Output). Owing to its cross-cutting nature, this paradigm is considered adaptable and broadly applicable within and across the various EFSA domains and, if applied using the definitions given in this guidance, is expected to help harmonise the problem formulation process and outputs and foster consistency in protocol development. APRIO may also overcome the difficulty of implementing some existing frameworks across the multiple EFSA disciplines, e.g. the PICO/PECO approach (Population, Intervention/Exposure, Comparator, Outcome). Therefore, although not mandatory, APRIO is recommended. The second step in protocol development is the specification of the evidence needs and the methods that will be applied for answering the assessment questions and sub-questions, including uncertainty analysis. Five possible approaches to answering individual (sub-)questions are outlined: using evidence from scientific literature and study reports; using data from databases other than bibliographic; using expert judgement informally collected or elicited via semi-formal or formal expert knowledge elicitation processes; using mathematical/statistical models; and - not covered in this guidance - generating empirical evidence ex novo. The guidance is complemented by a standalone 'template' for EFSA protocols that guides the users step by step through the process of planning an EFSA scientific assessment.

Project description:The importance of disinfection has recently been emphasized due to the increasing risk of the spread of infections such as coronavirus disease-2019 (COVID-19). In addition, disinfection for preventing the spread of COVID-19 is highly recommended. The increased use of biocidal products raises concerns regarding the potential health risks from exposure among disinfection workers. This study aimed to assess these exposure and health risks using questionnaires targeting disinfection workers who were exposed to the active substances in biocidal products used for disinfection during the COVID-19 pandemic. A follow-up survey was conducted among 271 disinfection workers for 10 working days within two weeks, and exposure factors with reference to disinfection were evaluated through interview-administered questionnaires. An exposure algorithm was used to evaluate the exposure of disinfection workers during disinfection. The hazard index (HI) was calculated by dividing the inhalation concentration obtained using the exposure algorithm and the dermal dose according to occupational exposure limits (OEL). A sensitivity analysis was conducted to identify the exposure factors with the greatest impact on the inhalation and dermal exposure algorithms. A logistic regression analysis was performed to verify the relationship with health effects and sociodemographic and exposure characteristics. The average number of disinfections performed during 10 working days was 17.5 ± 12.3 times. The type of disinfection work was divided into 2806 cases of COVID-19 prevention and disinfection and 1956 cases of regular pesticide application to prevent and remove any pests. The HI was ≥1, indicating a potential health risk, with the use of ethanol (6.50E+00), quaternary ammonium compounds (QACs; 1.49E+01), and benzalkonium chloride (BKC; 1.73E+00). Dermal exposure was more hazardous than inhalation exposure for 6 of the 11 active substances in biocidal products. The weight fraction and exposure time were the factors that most significantly influenced the inhalation and dermal exposure algorithms in the sensitivity analysis. Higher exposure concentrations were more likely to affect health (AOR: 3.239, 95% CI: 1.155-9.082). This study provides valuable information regarding the exposure and risk of disinfection workers to 11 biocidal active substances included in common disinfectants. Our results suggest that the use of ethanol, BKC, and QACs has potential health risks to disinfection workers, with a higher possibility of negative health impacts with increasing exposure concentration.

Project description:Vaccine-preventable diseases (VPDs) cause substantial morbidity and mortality in the United States Affiliated Pacific Islands (USAPI).* CDC collaborates with USAPI immunization programs to monitor vaccination coverage. In 2016, † USAPI immunization programs and CDC piloted a method for estimating up-to-date status among children aged 2 years using medical record abstraction to ascertain regional vaccination coverage. This was the first concurrent assessment of childhood vaccination coverage across five USAPI jurisdictions (American Samoa; Chuuk State, Federated States of Micronesia [FSM]; Commonwealth of the Northern Mariana Islands [CNMI]; Republic of the Marshall Islands [RMI]; and Republic of Palau).§ Differences in vaccination coverage between main and outer islands¶ were assessed for two jurisdictions where data were adequate.** Series coverage in this report includes the following doses of vaccines: ?4 doses of diphtheria and tetanus toxoids and acellular pertussis vaccine (DTaP); ?3 doses of inactivated poliovirus vaccine (IPV); ?1 dose of measles, mumps, and rubella vaccine (MMR); ?3 doses of Haemophilus influenzae type B (Hib) vaccine; ?3 doses of hepatitis B (HepB) vaccine; and ?4 doses of pneumococcal conjugate vaccine (PCV); i.e., 4:3:1:3:3:4. Coverage with ?3 doses of rotavirus vaccine was also assessed. Completion of the recommended series of each of these vaccines†† was <90% in all jurisdictions except Palau. Coverage with the full recommended six-vaccine series (4:3:1:3:3:4) ranged from 19.5% (Chuuk) to 69.1% (Palau). In RMI and Chuuk, coverage was lower in the outer islands than in the main islands for most vaccines, with differences ranging from 0.9 to 66.8 percentage points. Medical record abstraction enabled rapid vaccination coverage assessment and timely dissemination of results to guide programmatic decision-making. Effectively monitoring vaccination coverage, coupled with implementation of data-driven interventions, is essential to maintain protection from VPD outbreaks in the region and the mainland United States.

Dataset Information

EFSA Guidance Document for predicting environmental concentrations of active substances of plant protection products and transformation products of these active substances in soil: This guidance published on 19 October 2017 replaces the earlier version published on 28 April 2015.

Publications

EFSA Guidance Document for predicting environmental concentrations of active substances of plant protection products and transformation products of these active substances in soil: This guidance published on 19 October 2017 replaces the earlier version published on 28 April 2015.

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