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Ref. Ares(2019)2471880 - 08/04/2019 EUROPEAN COMMISSION JOINT RESEARCH CENTRE Directorate D – Sustainable Resources TENDER SPECIFICATIONS Part 2- Technical Specifications PROCEDURE no.: JRC/IPR/2019/OP/0040 Framework contract for the "Provision of laboratory analyses of plant protection products and antibiotic residues in soil samples" Page 1 of 20
PROCEDURE JRC/IPR/2019/OP/0040 FWC for provision of laboratory analyses of plant protection products and antibiotic residues in soil samples "Provision of laboratory analyses of plant protection products and antibiotic residues in soil samples" Framework contract Technical Specifications Invitation to tender no. JRC/IPR/2019/OP/0040 TABLE OF CONTENTS 1. INTRODUCTION....................................................................................................... 4 1. SERVICE REQUIREMENTS – ANALYSIS OF PLANT PROTECTION PRODUCTS AND ANTIBIOTICS .................................................................................................. 5 1.1. Objective ........................................................................................................... 5 1.2. Framework Contract implementation ............................................................... 8 1.3. Description of services under Stage 1 (maximum 24 months) ....................... 10 1.3.1. Initial transportation of samples to the Contractor’s facilities ...................... 10 1.3.2. Storage of topsoil samples before and while analyses are carried out .......... 10 1.3.3. Identification and registration of topsoil samples .......................................... 11 1.3.4. Preparation of samples to perform the analyses ............................................ 11 1.3.5. Performance of analyses and quantification of concentrations...................... 12 1.3.6. Analytical quality control and validation of results ....................................... 12 1.3.7. Registration and delivery of the results of the analyses.................................. 13 1.3.8. Reporting and meetings .................................................................................. 14 1.3.9. Project coordination ....................................................................................... 16 1.4. Description of services under Stage 2 (24 months) ........................................ 17 1.4.1. Guarantee........................................................................................................ 17 1.5. Overview of time schedule.............................................................................. 18 1.6. Other general modalities and responsibilities ................................................. 19 1.6.1. Place of Work .................................................................................................. 19 1.6.2. Communication and meetings ......................................................................... 19 1.6.3. Data and support provided by JRC Unit ........................................................ 20 1.6.4. Quality assurance and control ........................................................................ 20 1.6.5. Property and Confidentiality of the Data, Tools and Results ......................... 20 1.6.6. Interferential risks ........................................................................................... 21 Page 2 of 20
PROCEDURE JRC/IPR/2019/OP/0040 FWC for provision of laboratory analyses of plant protection products and antibiotic residues in soil samples 1. INTRODUCTION This procurement is related to the activity of the European Commission to develop a resource efficient, low-carbon economy to achieve sustainable growth. In this context, the role of soil resources on a sustainable model of economic growth has been well recognized by stakeholders and policymakers. Soil has a role as a habitat and gene pool, serves as a platform for human activities, landscape and heritage and acts as a provider of raw materials. The Soil Thematic Strategy1 (COM(2006)231) showed that soil degradation is a serious problem in Europe. Soil degradation has negative impacts on natural ecosystems and climate, human health, as well as on our economy. It is difficult to extrapolate current trends into the future based on the limited existing data. However, the human-induced driving forces causing soil degradation are showing an upward trend. For instance, land-use/cover changes and climate change (in the form of global warming and extreme weather events) are exacerbating degradation processes such as erosion and landslides, organic carbon and biodiversity decline, compaction, and salinization. Currently, the Roadmap to a Resource Efficient Europe2 (COM(2011)571) provide a long-term framework for actions in many policy areas related to climate change, energy, raw materials, agriculture, biodiversity and regional development. In all of them soil plays a key role. At this point, LUCAS Topsoil Survey supplies the necessary soil data to develop future actions towards a sustainable growth in Europe. LUCAS3 (Land Use/Land Cover Area Frame Survey) is a survey carried out by the Statistical Office of the European Union (EUROSTAT) to monitor land use/cover situation and changes over time in Europe. The sampling is based on a regular grid across Europe defined as the intersection points of a 2 x 2 km grid covering the territory of the EU, resulting in around 1,000,000 geo-referenced points. In 2009, the LUCAS survey was extended by including a topsoil component. The aim of the LUCAS topsoil component was to create a harmonised and comparable dataset of physical and chemical parameters of topsoil in the EU for supporting policymaking. Circa 200,000 points from the LUCAS grid were selected across 25 Member States (EU-27 except Bulgaria, Romania) as representatives for the LUCAS soil component. From these 200,000 points, topsoil (0-20 cm) samples were collected in 20,000 points following a standardized sampling procedure. Topsoil samples were collected from natural and semi-natural environments (i.e. agricultural land, woodland and grassland). Afterwards, samples were analysed for percentage of coarse fragments, particle-size distribution, pH, electrical conductivity, organic carbon, carbonates, phosphorous, total nitrogen, extractable potassium, cation exchange capacity, multispectral parameters and heavy metals in a central laboratory with standard methods. The same methodology was extended in 2012 to Bulgaria and Romania, where topsoil samples were collected and analysed. The Topsoil Survey was repeated in 2015 in the EU-27 Member States. Furthermore, Topsoil Survey was extended to Albania, Bosnia-Herzegovina, Croatia, Macedonia, Montenegro, Serbia and Switzerland. Overall, about 25,500 soil samples were collected in the LUCAS 2015 Survey. About 18,000 samples out of the 25,500 samples were collected in points also sampled in the LUCAS 2009/2012 Surveys. Topsoil samples were collected with the standardized LUCAS sampling procedure and analysed for the same physical and chemical parameters studied in LUCAS 2009 and 20124. The aim of the LUCAS 1 More info under http://ec.europa.eu/environment/soil/index_en.htm. 2 http://ec.europa.eu/environment/resource_efficiency/about/roadmap/index_en.htm 3 http://epp.eurostat.ec.europa.eu/statistics_explained/index.php/LUCAS_%E2%80%94_a_multi-purpose_land_ use_survey. 4 https://etendering.ted.europa.eu/cft/cft-display.html?cftId=1338 Page 3 of 20
PROCEDURE JRC/IPR/2019/OP/0040 FWC for provision of laboratory analyses of plant protection products and antibiotic residues in soil samples Surveys is to compare the topsoil data between surveys and to detect possible changes on physical and chemical parameters of topsoil at the EU territory over time. In 2018, the Topsoil Survey was carried out again with the same set of points of the EU-28 Member States surveyed in the previous LUCAS Topsoil Surveys (2009, 2012, and 2015). Overall, about 26,000 topsoil samples were collected in geo-referenced points located in natural and semi-natural environments (i.e. agricultural land, woodland and grassland). A subset of these topsoil samples (up to around 2500-3000 samples) will be considered by the Contractor for carrying out the analysis of various plant protection products (PPPs) and antibiotics. In addition, the European Parliament has raised serious concerns about the scale and situation of lindanecontaminated sites in the EU. Lindane and other hexachlorocyclohexane (HCH) substances were extensively produced and used in the EU as a broad spectrum insecticide until 2008Lindane production and use is now banned in the EU due to its persistence, bio-accumulative and toxic properties. However, high concentrations can still be found in production sites, waste deposits, landfills and stockpiles of HCH and lindane in the EU according to several reports produced by the European Parliament and the United Nations. In this context, the Commission would like to develop a comprehensive inventory of lindane/HCH-contaminated sites to support their control and the implementation of remediation procedures in the EU. A set of about soil samples (up to an eventual maximum of 2500-3000 samples), taken in the context of the LUCAS 2018 survey and from targeted areas, will be considered by the Contractor for carrying out the analysis of various HCH substances in the implementation of the framework contract. 1. SERVICE REQUIREMENTS – ANALYSIS OF PLANT PROTECTION PRODUCTS AND ANTIBIOTICS 1.1. Objective The objectives of the framework service contract are: − Objective 1: to analyse the presence of plant protection products (PPPs), shown in Table 1 and Table 2 (if offered), in up to around 2500-3000 soil samples taken in natural and semi-natural environments (mineral and organic soils in agricultural land and grassland) in the context of the LUCAS 2018 survey. − Objective 2: to quantify concentrations of selected PPPs, as shown in Table 1 and Table 2 (if offered), in the soil samples analysed in objective 1. − Objective 3: to analyse the presence and quantify the concentration of alpha- hexachlorocyclohexane, beta-hexachlorocyclohexane and gamma- hexachlorocyclohexane shown in Table 1 up to an eventual maximum of 500 soil samples taken in targeted areas (production sites, waste deposits, landfills and stockpiles) across Europe. − Objective 4: to analyse the presence and quantify the concentration of antibiotics shown in Table 1 up to an eventual maximum of 700 soil samples taken in natural and semi- natural environments (mineral and organic soils in agricultural land and grassland) in the context of the LUCAS 2018 survey across Europe. Page 4 of 20
PROCEDURE JRC/IPR/2019/OP/0040 FWC for provision of laboratory analyses of plant protection products and antibiotic residues in soil samples The analysis shall be carried out following standard methods detailed in these technical specifications. The results shall be reported according to the units of measurement and decimal digits reported in the tables below. Table 1. Core substances to analyse and quantify concentration Indicative Presence in Concentration Compound Units Decimals LOQ1 (mg/kg) the sample (Yes/No2) Plant protection products Abamectin 0.005 ̶ 0.01 Yes Aldrin 0.005 ̶ 0.01 Yes AMPA 0.005 ̶ 0.01 Yes Yes mg/kg 2 Atrazine 0.005 ̶ 0.01 Yes Yes mg/kg 2 Atrazine-deisopropyl 0.005 ̶ 0.01 Yes Yes mg/kg 2 Atrazine-desethyl 0.005 ̶ 0.01 Yes Yes mg/kg 2 Azoxystrobin 0.005 ̶ 0.01 Yes Yes mg/kg 2 Boscalid 0.005 ̶ 0.01 Yes Yes mg/kg 2 Carbaryl 0.005 ̶ 0.01 Yes Carbofuran 0.005 ̶ 0.01 Yes Carbofuran, 3-hydroxy 0.005 ̶ 0.01 Yes Carbofuran, -keto 0.005 ̶ 0.01 Yes Chlordane alpha 0.005 ̶ 0.01 Yes Chlordane gamma 0.005 ̶ 0.01 Yes Chlordecone 0.005 ̶ 0.01 Yes Chlorfenvinphos 0.005 ̶ 0.01 Yes Chlorpyrifos 0.005 ̶ 0.01 Yes Chlorpyrifos-methyl 0.005 ̶ 0.01 Yes Clothianidin 0.005 ̶ 0.01 Yes Yes mg/kg 2 Cymoxanil 0.005 ̶ 0.01 Yes Cyproconazole 0.005 ̶ 0.01 Yes Yes mg/kg 2 Cyprodinil 0.005 ̶ 0.01 Yes Yes mg/kg 2 DDD op 0.005 ̶ 0.01 Yes DDD pp 0.005 ̶ 0.01 Yes DDE op 0.005 ̶ 0.01 Yes DDE pp 0.005 ̶ 0.01 Yes DDT op 0.005 ̶ 0.01 Yes DDT pp 0.005 ̶ 0.01 Yes Deltamethrin 0.005 ̶ 0.01 Yes Yes mg/kg 2 Diazinon 0.005 ̶ 0.01 Yes Dieldrin 0.005 ̶ 0.01 Yes Difenoconazole 0.005 ̶ 0.01 Yes Yes mg/kg 2 Diflufenican 0.005 ̶ 0.01 Yes Yes mg/kg 2 Dimethomorph 0.005 ̶ 0.01 Yes Diuron 0.005 ̶ 0.01 Yes Page 5 of 20
PROCEDURE JRC/IPR/2019/OP/0040 FWC for provision of laboratory analyses of plant protection products and antibiotic residues in soil samples Indicative Presence in Concentration Compound Units Decimals LOQ1 (mg/kg) the sample (Yes/No2) Endosulfan alpha 0.005 ̶ 0.01 Yes Endosulfan beta 0.005 ̶ 0.01 Yes Endosulfan sulphate 0.005 ̶ 0.01 Yes Endrin 0.005 ̶ 0.01 Yes Epoxiconazole 0.005 ̶ 0.01 Yes Yes mg/kg 2 Ethion 0.005 ̶ 0.01 Yes Fenpropimorph 0.005 ̶ 0.01 Yes Yes mg/kg 2 Fluometuron 0.005 ̶ 0.01 Yes Fluopicolide 0.005 ̶ 0.01 Yes Yes mg/kg 2 Fluroxypyr 0.005 ̶ 0.01 Yes Fluzinam 0.005 ̶ 0.01 Yes Yes mg/kg 2 Folpet 0.005 ̶ 0.01 Yes Yes mg/kg 2 Glyphosate 0.05 Yes Yes mg/kg 2 Heptachlor 0.005 ̶ 0.01 Yes Heptachlor epoxide 0.005 ̶ 0.01 Yes Hexachlorobenzene 0.005 ̶ 0.01 Yes Hexachlorocyclohexane, 0.005 ̶ 0.01 Yes Yes 3 mg/kg 3 23 alpha 0.005 ̶ 0.01 Yes Yes 3 mg/kg Hexachlorocyclohexane, beta 3 23 Hexachlorocyclohexane, 0.005 ̶ 0.01 Yes Yes 3 mg/kg 3 23 gamma Imazalil 0.005 ̶ 0.01 Yes Imidacloprid 0.005 ̶ 0.01 Yes Yes mg/kg 2 Isoproturon 0.005 ̶ 0.01 Yes Linuron 0.005 ̶ 0.01 Yes Malathion 0.005 ̶ 0.01 Yes Metalaxyl 0.005 ̶ 0.01 Yes Metamitron 0.005 ̶ 0.01 Yes Metconazole 0.005 ̶ 0.01 Yes Yes mg/kg 2 Myclobutanil 0.005 ̶ 0.01 Yes Parathion 0.005 ̶ 0.01 Yes Parathion-methyl 0.005 ̶ 0.01 Yes Penconazole 0.005 ̶ 0.01 Yes Pentachlorobenzene 0.005 ̶ 0.01 Yes Pendimethalin 0.005 ̶ 0.01 Yes Yes mg/kg 2 Phthalimide 0.005 ̶ 0.01 Yes Pinoxaden 0.005 ̶ 0.01 Yes Pirimiphos-methyl 0.005 ̶ 0.01 Yes Prochloraz 0.005 ̶ 0.01 Yes Yes mg/kg 2 Procymidone 0.005 ̶ 0.01 Yes Propiconazole 0.005 ̶ 0.01 Yes Page 6 of 20
PROCEDURE JRC/IPR/2019/OP/0040 FWC for provision of laboratory analyses of plant protection products and antibiotic residues in soil samples Indicative Presence in Concentration Units Decimals Compound LOQ1 (mg/kg) the sample (Yes/No2) Prothioconazole 0.005 ̶ 0.01 Yes Pyraclostrobin 0.005 ̶ 0.01 Yes Quinoxyfen 0.005 ̶ 0.01 Yes Simazine 0.005 ̶ 0.01 Yes Tebuconazole 0.005 ̶ 0.01 Yes Yes mg/kg 2 Terbuthylazine 0.005 ̶ 0.01 Yes Terbuthylazine-desethyl 0.005 ̶ 0.01 Yes Thiamethoxan 0.005 ̶ 0.01 Yes Yes mg/kg 2 Triadimenol 0.005 ̶ 0.01 Yes Trifloxystrobin 0.005 ̶ 0.01 Yes Antibiotics Colistin 0.006 ̶ 2 Yes Yes mg/kg 2 Enrofloxacin 0.006 ̶ 2 Yes Yes mg/kg 2 1 LOQ: limit of quantification 2 An empty cell means no quantification of concentration is required for the substance 3 The quantification of the concentration of this substance is only required for objective 3. Note: The data of the analyses shall be reported on the air-dry soil mass basis. Table 2: extra substances to analyse and quantify concentration Compound Analysis and quantification of Presence concentration of substances in Indicative in the Concentration Units Decimals Table 2 (if offered) will be LOQ1 (mg/kg) sample undertaken together with substance in Table 1. Quinoxyfen 0.005 ̶ 0.01 Yes Yes mg/kg 2 Dimoxystrobin 0.005 ̶ 0.01 Yes Yes mg/kg 2 Fludioxonil 0.005 ̶ 0.01 Yes Yes mg/kg 2 Fluquinconazole 0.005 ̶ 0.01 Yes Yes mg/kg 2 Myclobutanil 0.005 ̶ 0.01 Yes Yes mg/kg 2 Diquat 0.005 ̶ 0.01 Yes Yes mg/kg 2 Imazamox 0.005 ̶ 0.01 Yes Yes mg/kg 2 Lenacil 0.005 ̶ 0.01 Yes Yes mg/kg 2 1 LOQ: limit of detection Note : The data of the analyses shall be reported on the air-dry soil mass basis. 1.2. Framework Contract implementation The framework contract involves no direct commitment and, in particular, does not constitute an obligation to order per se. Instead, it lays down the legal, financial, technical and administrative provisions governing the relationship between the contracting authority and the contractor during its period of validity. Page 7 of 20
PROCEDURE JRC/IPR/2019/OP/0040 FWC for provision of laboratory analyses of plant protection products and antibiotic residues in soil samples The framework contract will be implemented through specific contracts that can be placed only after the signature and entry into force of the framework contract The services will be provided on the basis of specific contracts where the contracting authority, specifies the quantity and quality/origin/composition of soil samples and the tasks that will have to be carried out. In each case the process is initiated by the contracting authority by sending a request for services. Specific contracts can be placed by the Land Resources Unit of the Directorate-General Joint Research Centre (JRC.D3) or the Land Use & Management of Directorate-General Environment (ENV.D1), These specific contracts will be implemented in two stages. • Stage 1 will involve the following services: o initial transportation of samples to the Contractor’s facilities o storage of the soil samples before and while analyses are carried out o identification and registration of samples o preparation of samples for the performance of analysis o performance of analyses and quantification of concentrations o analytical quality control and validation of results o registration and delivery of the results of the analyses o reporting and meetings o project coordination It is foreseen that the first specific contract will have a duration of 24 months. The following ones, if any, may be equal or shorter. The details of the services in Stage 1, described in this Technical Specifications, are intended for the foreseen first specific contract. The services in the following specific contracts, if any, will be similar, although the conditions for the initial transportation, identification and registration of samples, preparation of samples and reporting may be adapted on the basis of the quantity and origin of the samples and of the duration of the specific contracts. • Stage 2 of all Specific Contracts will have a duration of 24 months and will involve: o a guarantee period (24 months) Upon the signature of a Specific Contract, the Contractor shall undertake only the work concerning Stage 1, the only Stage having come into force at that point. The contractor is authorised to continue the performance of the contract in the second stage only with written consent of the contracting authority. For brand names indicated in the Technical Specifications, fully equivalent objects are accepted only if the contractor provides evidence of the equivalence (as per its offer). Page 8 of 20
PROCEDURE JRC/IPR/2019/OP/0040 FWC for provision of laboratory analyses of plant protection products and antibiotic residues in soil samples The results of the analyses will feed into the knowledge base that the European Commission wishes to build in the context of policymaking in the areas of soil protection and management. The services shall be carried out under the technical guidance of the Contracting Authority (JRC.D3 or ENV.D1). 1.3. Description of services under Stage 1 (maximum 24 months) The tenderers shall present the working program in the technical offer on the basis of one hypothetical specific contract for all the analysis in objectives 1, 2 and 4. The working program shall include a Gantt chart with all services to carry out in Stage 1, including transportation forecast, duration of services and timing for delivery of results, reports and meeting. 1.3.1. Initial transportation of samples to the Contractor’s facilities The Contractor will work with air-dried and fresh (field-moist) samples of circa 50 g each. Soil samples will be packed in labelled plastic bags. Transportation of fresh samples The Contractor shall arrange the shipment of about 600 samples (50 g each) stored at −20ºC in the premises of the JRC (Ispra 21027, Varese, Italy) to the Contractor's laboratory. It is noted that this amount of samples shall be transported in the first specific contract. In the following contracts, if any, the number of samples may be similar or lower. It is underlined that all organisational aspects, such as custom issues, and all costs of the take over and dispatching of the soil samples to the Contractor's laboratory, are part of the present contract under Contractor's responsibility. The Contractor shall provide evidence (e.g. proofs of regulation/monitoring of temperature of the truck during the transportation) for the timely and secure transport of samples from the premises of the JRC Ispra to the Contractor’s laboratory. The transportation of samples shall be done in a single shipment, within 20 working days from the signature of the relevant specific contract. Transportation of air-dried samples The Contracting Authority will arrange the shipment of the air-dried samples to the Contractor’s laboratory. The Contractor will receive air-dried samples within 20 working days from the signature of the relevant specific contract. 1.3.2. Storage of topsoil samples before and while analyses are carried out The Contractor shall store properly fresh and air-dried samples when they arrive at the laboratory. Requirements • The Contractor shall formally inform the Contracting Authority of the reception of fresh and air-dried samples by email. The contractor shall send a reception document (in PDF format), indicating the date of the samples’ reception at their premises and the number of samples received within a week of the delivery. Page 9 of 20
PROCEDURE JRC/IPR/2019/OP/0040 FWC for provision of laboratory analyses of plant protection products and antibiotic residues in soil samples • The laboratory shall have enough storage space to allow temporary storage of the incoming topsoil samples prior to and pending further analyses. • Air-dried samples shall be kept without preservative under normal room conditions (at a temperature of 18-25ºC and at about 50% humidity), with minimal temperature and humidity fluctuations, and shielded from incident sunlight. • Fresh samples shall be kept without preservative, at a maximum temperature of 4 ºC, with minimal temperature fluctuations. Temperature recording logbook shall be made available for inspection, if requested by the Contracting Authority. 1.3.3. Identification and registration of topsoil samples Soil samples will be labelled with an individual identification code (referred to as Soil_ID) in numeric format and as ‘code 128’ barcode. Each Soil_ID is composed of five digits. The Contracting Authority will provide the Contractor with a register of Soil_IDs, specifying which analyses shall be performed at each subsample, no later than 10 working days from the signature of the relevant specific contract. Requirements • The contractor shall identify each sample by reading its Soil_ID. To that end, a barcode scanner that is able to read ‘code 128’ is required. • The identification and registration of samples shall be completed 15 calendar days after the delivery of samples in the Contractors’ facilities. • The Soil_IDs of the received topsoil samples shall be communicated to the Contracting Authority within 1 week from the end of the reading process. This will determine the exact number of samples to be analysed. 1.3.4. Preparation of samples to perform the analyses The Contractor will receive air-dried samples, sieved at 2 mm, and fresh samples, not sieved. The samples have to be prepared for the various analyses in Table 1 and Table 2 (if offered). Requirements • The Contractor shall prepare the samples following the ISO 11464:2006 procedure or any other validated procedure for their analysis. • The Contractor shall describe in the offer what pre-treatments will apply to each type of sample (air-dried and fresh samples). • A full description of the pre-treatment of samples shall be included in the validation report (see section 1.3.5 below). • The Contractor shall pre-treat topsoil samples under stringent quality assurance and quality control (QA/QC) procedures to avoid any cross-contamination among samples. Page 10 of 20
PROCEDURE JRC/IPR/2019/OP/0040 FWC for provision of laboratory analyses of plant protection products and antibiotic residues in soil samples 1.3.5. Performance of analyses and quantification of concentrations The Contractor shall analyse samples for the substances specified in Table 1 and Table 2 (if offered) in a fully operational soil laboratory facility capable to handle soil samples. The Contractor shall describe in the offer what analytical procedure they will use for the analysis of substances specified in Table 1 and Table 2 (if offered). The samples shall be analysed for all PPPs (except glyphosate and AMPA) and antibiotics with a fully validated multi-residue method such as QuEChERS or equivalent, compliant to the requirements listed in the Eurache Guide (2nd Edition, 2014)5. Glyphosate and AMPA shall be analysed separately, with a fully validated procedure compliant to the requirements listed in the Eurache Guide (2nd Edition, 2014)5. The full validation report of the entire analytical procedure (analyses in Table 1 and Table 2, if offered) shall be available to the Contracting Authority for revision no later than 3 months after the signature of the relevant specific contract. This report shall include an Excel document (or 100% Excel-compatible) with the mass of each sample needed for the analyses of substances specified in Table 1 and Table 2 (if offered). The mass of the subsamples cannot exceed 50 g, due to sampling constraints. The laboratory facility shall guarantee the completion of analysis in the specified timeframe indicated in section 1.3.7. It is noted that the extracts from soil samples analysed in the Objective 1 (these analysis are foreseen to be included in the first specific contract) shall be stored in proper conditions for the duration of this framework contract for their possible use in subsequent specific contracts. The Contractor shall calculate the concentration of substances as indicated in Table 1 and Table 2 (if offered). Requirements • Analyses shall be done on a country by country basis. • It is mandatory that the analysis of all samples for a single substance or a set of substances shall be done in a single laboratory. Single substances can be analysed in parallel by different laboratories. 1.3.6. Analytical quality control and validation of results The Contractor shall specify in the offer what analytical quality control and data validation they will apply in this project. The quality control criteria and validation parameters shall be in line with those described in the Eurache Guide (2nd Edition, 2014). Requirements: 5B. Magnusson and U. Ornemark (eds.) Eurachem Guide: The Fitness for Purpose of Analytical Methods – A Laboratory Guide to Method Validation and Related Topics, (2nd ed. 2014). ISBN 978-91-87461-59-0. Available from www.eurachem.org. Page 11 of 20
PROCEDURE JRC/IPR/2019/OP/0040 FWC for provision of laboratory analyses of plant protection products and antibiotic residues in soil samples A description of the analytical quality control and of the validation of results shall include at least: • Analysis of reference quality control (QC) samples within each analytical batch for the identification of system drift • Analysis of blank samples for identification of matrix contribution • Duplicate analysis of adjacent samples for repeatability check • Use of control charts for monitoring of QC results • Definition of the level of internal QC (i.e. 5% for routine analysis) applicable to analytical batches. 1.3.7. Registration and delivery of the results of the analyses The information generated through the analyses of each sample constitutes a set of attributes to a specific location. The geographic coordinates of the points corresponding to the sampling location are not provided. Special care has to be taken in the registration of the results of the analyses to ensure that the data attributed to a Soil_ID are appropriately referenced in the database. The Contractor shall register and deliver the results of the analyses to the Contracting Authority according to the following requirements. Requirements for the registration and delivery of results: • Spectral data of each sample shall be registered and delivered to the Contracting Authority in comma-delineated ASCII files. The file shall include the following information: Soil_ID, Country, date of the measurement, method used and equipment used. • Each file shall be identified with the Soil_ID and the ISO ALPHA-2 code of the country as follows: 12548_BE. • Concentration of each substance requested in Table 1 and Table 2 (if offered) shall be delivered in an Excel (or 100% Excel-compatible) data workbook. The data workbook shall have the schema detailed below. Core fields Column 1 ID of the sample (Soil_ID) Column 2 Country (as indicated in the label) Column 3 Concentration substance 1 Column 4 Concentration substance 2 Column 5 Concentration substance 3 […] Column $$ Comments / Observations Page 12 of 20
PROCEDURE JRC/IPR/2019/OP/0040 FWC for provision of laboratory analyses of plant protection products and antibiotic residues in soil samples • The results of the analyses shall be communicated in the format specified above to the Contracting Authority on a monthly basis, in any case within one month from the completion of the analyses on each soil sample. • Analysis of substances in Table 1 and Table 2 (if offered) shall be completed no later than 23 months from the signature of the relevant specific contract. It is noted that the timing for the following contracts (if any) may be shorter. 1.3.8. Reporting and meetings The language of communication between the Contractor and the Contracting Authority will be English. All reports shall be written in English, the meetings will be held in English and the email exchange will also be in English. The contractor is asked to submit all required reports electronically to the specified contact person(s) of the Contracting Authority. All reports shall include the following mandatory information: contractor, contract number, nature of the report, subject, name of the author and original signature. 1.3.8.1. Project progress emails The project progress emails are each a brief, bullet-point style summary of the project’s monthly working progress to be sent together with the results of the analyses by the contractor to the JRC on a monthly basis. These emails shall provide a concise summary of the previous month’s work (including the status of the delivery of results, activities and meetings with dates, involved experts and stakeholders, technical and administrative issues, etc.) and have to show the progress of the work in relation to the project and the initial or adjusted working plan. These emails will help the JRC to stay informed about the project status and, if necessary, to timely steer the project towards the requested deliverables. The project progress emails will also form the basis for the progress, interim and the final reports (see below) that will give the chronological course of the project’s activities and achievements. 1.3.8.2. Validation report A report describing a fully validated analytical procedure, compliant to the requirements listed in the Eurache Guide (2nd Edition, 2014), for the substances specified in Table 1 and Table 2 (if offered) shall be sent to the Contracting Authority within the time defined in the relevant specific contract. This report shall include an Excel document (or 100% Excel-compatible) with the mass of each sample needed for the analyses of substances specified in Table 1 and Table 2 (if offered). The Contracting Authority will formally inform the Contractor of the approval of the validation report by email within two weeks of its reception. Analyses of the soil samples shall not start before the approval of the validation report. 1.3.8.3. Interim report A technical report with a description of the on-going work, a list of any technical issues concerning the processing of the samples, the methodologies and the database, and a brief presentation of the main results to date shall be sent to the Contracting Authority after the signature of the relevant specific contract/s by the month defined in each specific contract. At least 25% of all measurements shall be completed for the technical report, unless otherwise defined in the relevant Page 13 of 20
PROCEDURE JRC/IPR/2019/OP/0040 FWC for provision of laboratory analyses of plant protection products and antibiotic residues in soil samples specific contract. The Contractor shall provide the JRC with an electronic version of the report, in both Word and PDF format. The interim progress report together with the monthly project progress emails will serve to decide whether the project’s initial objectives are being achieved in line with the contract, including possible adjustments and amendments made, as well as whether the remainder of the project can be expected to be completed as foreseen. The interim progress report together with the monthly project progress emails will be the basis for the interim payment of the stage 16. The Contracting Authority shall formally inform the Contractor of the approval of the Interim Report by email 2 weeks after its receipt. The approval of the technical report is necessary for the interim payment. 1.3.8.4. Final report Stage 1 The Contractor will have 1 month after the end of the analyses and quantification of concentrations to deliver the final report of the Stage 1 (by the end of the relevant specific contract at the latest). The final report shall include, a presentation of the results of the analyses as well as a full statistical evaluation of such results, and any particular observation (technical or administrative) made during the work. The report shall also include and executive summary with the following information: a description of the project, its purpose and scopes, a description of the reports delivered to date, main results, conclusions and recommendations, key technical and administrative details (i.e. limitations, assumptions), potential users and applications of the results as defined in this call for tender and the expected benefits of the achievements. The executive summary shall be written using non-technical language, targeting upper level management. All results will be backed-up on CD-ROM/DVD and sent to the Contracting Authority together with the final report. The Contractor is responsible for the implementation of a robust data processing and back-up practice. Malfunctioning of equipment shall not lead to delays in providing data according to the delivery schedule. The Contractor shall provide the Contracting Authority with an electronic version of the report, in both Word and PDF format. A final project meeting may be organized 2 weeks after the JRC receives the Final report of Stage 1 (see section 1.3.8.7) of the relevant Specific Contract. The Contracting Authority will formally inform the Contractor of the approval of the Final Report by email 2 weeks after the meeting. The final report (once approved by the Contracting Authority) will be, together with the rest of reports delivered to date, the basis for the final payment of the Stage 1 of the relevant specific contract7. The final payment will be done once the Final Report will be approved by the Contracting Authority. 6 as per article I.6.2 of the Contract 7 as per article I.6.3 of the Contract Page 14 of 20
PROCEDURE JRC/IPR/2019/OP/0040 FWC for provision of laboratory analyses of plant protection products and antibiotic residues in soil samples 1.3.8.5. Other reports The Contracting Authority may request ad hoc analysis and short reports, which may be requested on any specific issue, to guarantee the correct progress of the project. 1.3.8.6. Kick-off meeting The Contractor and the Contracting Authority services shall hold a kick-off meeting at the beginning of the framework contract which may be combined with the kick off meeting of the first Specific Contract. The Contractor shall send templates of the workbook for the registration and delivery of samples, the project progress emails and the reports five days before the meeting. The appropriateness of the templates will be discussed in the kick-off meeting. The minutes of the meeting shall be drafted by the Contractor and submitted, no later than one week after the meeting, to the Contracting Authority for approval. The meeting minutes shall contain at a minimum: names and details of all participants, statements made in agreement with or in contradiction to any general consensus of the group and information and clear references on presentation given and sources used in the meeting. The Contracting Authority will communicate the contact person(s) responsible for this framework service contract. 1.3.8.7. Final project meeting Stage 1 The final project meeting may be organized 2 weeks after the Contracting Authority receives the Final report of Stage 1 of the relevant Specific Contract. The contractor shall present the final results and conclusions of the project. The minutes of the meeting shall be drafted by the Contractor and submitted to the Contracting Authority for approval no later than a week after the meeting. The JRC will formally inform the Contractor of the approval of the minutes of the meeting by email 2 weeks after the meeting (together with the approval of the Final Report of Stage 1). 1.3.9. Project coordination Project coordination covers all matters of project organization, such as distribution and follow-up of tasks, communication, documentation and reporting and quality assurance procedures. The tenderers shall present a project coordination plan detailing, at least, the following aspects: • Description of the project and its objectives: tenderers shall demonstrate having understood the project requirements in the offer presented. The aim of the project, the development required and the results expected must be clearly expressed. • Work plan: a Gantt chart detailing the temporal sequence of the tasks to be performed within the project shall be presented. The deadlines for all services (i.e. transportations, pre- treatment and analysis of samples, delivery of data, meetings and reporting) shall be indicated in the chart. • Tools for monitoring the project progress: this section shall cover monitoring elements, such as internal review meetings, internal milestones and their place in the project work plan. • Description of the staff involved in the project: the technical and human resources planned to perform the tasks have to be presented. For the intended technical resources, the Page 15 of 20
PROCEDURE JRC/IPR/2019/OP/0040 FWC for provision of laboratory analyses of plant protection products and antibiotic residues in soil samples environment in which the system will be developed shall be described. Staff shall be presented with respect to their responsibility, their position in the project and relevant experience. • Description of the means of coordination and flow of information: the tenderers shall present in the proposal the internal communication flow of the proposed service. The structure of the decision-making process shall be detailed and measures adopted to solve any conflict within the project shall be outlined. The tenderers have also to explain how the tender intends to communicate with the JRC in case of technical and administrative issues. • Procedures to be observed: any interdependencies between tasks with regard to outputs of one task representing critical input items for another task (e.g. tools development and use in data checking) shall be explained. Eventual risks in achieving the objectives shall be identified, as well as possible recovery measures to reduce the impact of delays on the achievement of objectives. • Measurements for project continuity: the proposal shall describe the back-up system that will assure the continuity of the project (i) in case of absence of a key profile in the staff and (ii) in case of breakdown of key equipment for the analyses. • Tools for quality management: the proposal shall contain a description of the quality management tool(s) intended to be used in the project, e.g. relational diagrams, flowcharts, tree diagrams, etc. For the laboratory service, documentation of experience, quality assessment and control, participation in ring tests and inter-laboratory exercises shall be documented. • Quality Control procedure for data validation: the approach to ensuring the quality of the data shall be detailed. The tenderer shall present the approach that the laboratory regularly uses for the data validation, in addition to the quality control measures detailed in this Technical Specifications. 1.4. Description of services under Stage 2 (24 months) 1.4.1. Guarantee Upon the written release of Stage 1 by the Contracting Authority, the guarantee period shall start. A guarantee of two years is required on the accuracy of information, starting from the day of the approval of the final report Stage 1 of the relevant Specific Contract. This guarantee is required if seemingly anomalous values (i.e. data outliers), that become apparent during subsequent processing of the data of the analysis of any sample, may be the result of variations in the analytical processes rather than environmental conditions (which will be checked before any request is made under the guarantee clause). The Contracting Authority can request the contractor to check if any issue can be detected from the analytical logs. Should it be shown that logistical or analytical processes undertaken by the contractor have led to erroneous values, the JRC will request the contractor to reanalyse the sample(s) in question. • All relevant information of the logistics and processing analytical work shall be recorded for every single analysis carried out in each soil sample. Page 16 of 20
PROCEDURE JRC/IPR/2019/OP/0040 FWC for provision of laboratory analyses of plant protection products and antibiotic residues in soil samples • The information shall be kept at the service provider during the guarantee period (24 months). • If the Contracting Authority requests details on the issue of logistics and analytical process, the contractor shall provide all relevant details no later than 10 working days from the JRC request. • If requested by the Contracting Authority, the contractor shall reanalyse the sample(s) with anomalous values. 1.5. Overview of time schedule The framework contract will have a total duration of 36 months as of its signature and entry into force (2 years + 1 renewal for 1 year). o Stage 1 of all Specific contracts shall be completed within maximum 24 months of the signature of the specific contract. o Stage 2 shall be completed within maximum 24 months of the written release of Stage 1 by the Contracting Authority. The timing for reports and meetings will be as follows (Table 3 is based of one hypothetical specific contract for all the analysis in objectives 1, 2 and 4 where stage 1 would have a duration of 24 months). The timeschedule will be adapted in each Specific Contract, depending on the duration of the Specific contract and of the quantity of analysis to be performed. Table 3: Overview of reporting and meetings Timing Reference Title Type of deliverable Stage 1. Within 3 M1 Kick-off meeting Meeting: weeks after - detailed presentation of work signature of the plan by the contractor contract - communication of the contact person for this service person by the Commission Stage 1. Within a R1 Reception document Document confirming the good week of the reception of the samples. Indicate reception of the the date of the reception and the samples at the number of samples received. Contractors’ premises Stage 1. On a PR-Year- Project progress emails Written report: a brief, bullet-point monthly basis Month style summary of the project’s monthly working progress Stage 1. R2 Validation report A report describing a fully Maximum: 3 validated analytical procedure, Page 17 of 20
PROCEDURE JRC/IPR/2019/OP/0040 FWC for provision of laboratory analyses of plant protection products and antibiotic residues in soil samples Timing Reference Title Type of deliverable months after the compliant to the requirements signature of the listed in the Eurache Guide (2nd contract Edition, 2014). Stage 1. R3 Technical report Written report including: Maximum: 11 - a list of any technical issues months after the concerning the processing of the signature of the samples, the methodologies and contract the database - a brief presentation of the main results Stage 1. R4 Final report Stage 1 Written report: presentation by the (Maximum: 24 contractor of the main results of months after the the analyses carried out in Stage 1 signature of the (including results of analyses and contract) statistical evaluation) and description of methodologies Stage 1. M2 Final project meeting Meeting: presentation of results Maximum 2 and conclusions of the project by weeks after the the contractor. Contracting Authority receives the Final Report of Stage 1 Stage 2. G1 Guarantee on information Information if required Guarantee (24 months of the written release of Stage 1 by the JRC Ispra) 1.6. Other general modalities and responsibilities 1.6.1. Place of Work The principal place of work will be the contractor's facilities (“off-site”). 1.6.2. Communication and meetings Communication between the contractor and the Contracting Authority must be possible by phone, video-conference, electronic mail, fax, normal and registered mail. The English language shall be used throughout the project duration for all communication, reports, software and other documentation. Further information will be provided by the Contracting Authority. Modalities will be clarified at the kick-off meeting. The principal contact point for the contractor is the JRC. The JRC contact person will act as the interface between the service provider and the soil sample providers in case of queries concerning the soil samples provided. In case of a query on the soil samples provided, the contractor will Page 18 of 20
PROCEDURE JRC/IPR/2019/OP/0040 FWC for provision of laboratory analyses of plant protection products and antibiotic residues in soil samples describe the problem in writing. The JRC will then conduct all communication with the relevant providers. Direct contacts between the service provider and sample providers can be established following written authorization from the JRC. Under no circumstances shall samples or data be modified by the service provider without written instruction from the Contracting Authority. Kick-off and Final project meetings, when foreseen by the relevant specific contract shall be held at the JRC in Ispra (Italy) or at DG ENV (Brussels) or by video/phone conference. The cost of transport, accommodation and other staff-related costs for the contractor' experts for the meetings will be covered by the contractor. 1.6.3. Data and support provided by JRC Land Resources Unit The Contracting Authority Technical Manager (Contact Person) follows the work of the contractor, tracks the technical problems arising during the work and supports finding solutions. He/she is the point of contact for the contractor. The service provider must indicate its technical contact person during the kick-off meeting. The Contracting Authority will provide a register with the Soil_IDs of samples that the Contractor will receive 1 week after the signature of the relevant specific contract. 1.6.4. Quality assurance and control 1.6.4.1. Project Management Plan The contract shall be implemented in accordance with the Project Management Plan and schedule proposed in the Technical Offer. 1.6.4.2. Acceptance of deliverables (results, reports, and meeting minutes) The procedure for accepting the deliverables is the following: 1. The Contracting Authority receives the deliverables according to the relevant Specific Contract's deadlines; 2. If required, the contractor presents the deliverables for discussion with the Contracting Authority; Further actions which, in the opinion of the Contracting Authority, would be necessary for the acceptance of the deliverables will be undertaken by the contractor without delay. A new deliverable which takes into account comments or suggestions made by the Contracting Authority will have to be re-submitted within 14 days unless specified otherwise. 1.6.5. Property and Confidentiality of the Data, Tools and Results and their publication Soil samples handed over for analysis, results of the analyses, and any database developed under this contract are confidential and remain the exclusive property of the Contracting Authority, as provided for in Articles II.13 of the General Conditions of the contract. Page 19 of 20
PROCEDURE JRC/IPR/2019/OP/0040 FWC for provision of laboratory analyses of plant protection products and antibiotic residues in soil samples The ownership of the results, including the intellectual property rights obtained in the performance of the contract, may be used by the European Union without limitation, as indicated in the modes of exploitation listed in Article I.10.1 of the contract, for further developments, updates and modifications also by third parties (on behalf of the contracting authority). If the results are not fully created for the purpose of the contract this should be clearly pointed out by the tenderer in the tender. Information shall be provided about the scope of pre-existing rights, their source and when and how the rights have been or will be acquired. If the contractor uses pre-existing rights for processing and/or delivery of the contract results, it shall present a list of all pre-existing rights and all components, elements and rights of third parties, used as well as any related limitations. The contractor has to ensure that the necessary pre-existing IPR rights are licensed to the contracting authority in accordance with articles I.10.2 and II.13 of the contract. Further distribution of documentation, reports, and other deliverables of the project and the presentation of any results in any language and form such as in a journal article, on the contractor’s homepage, via presentation at a conference, etc., by the contractor or any third party is prohibited unless authorised in writing prior to publication / abstract submission by the Contracting Authority. The Contracting Authority/European Commission will decide on the possible use of the deliverables and any other information/document produced under this assignment. 1.6.6. Interferential risks During the takeover of samples in Ispra, the JRC.D3 will ensure that: • appropriate preventative safety measures are taken; • no experimental or other activity takes place, whether from JRC.D3 or other external personnel; As a consequence the possible interferential risks are eliminated or reduced to a level that is not significant. Page 20 of 20
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