Joint FAO/WHO Meeting On Pesticide Residues Research Articles

Аналіз міжнародних підходів до нормування пестицидів у продуктах переробки сільськогосподарської сировини (огляд літератури)

Object . Analysis of pesticide regulations documents and scientific works regarding processed agricultural products. Results. The principles to establish maximum residue levels (MRLs) for active ingredients of pesticides in raw agricultural commodities (RACs) and processed products are currently available in the European Union and Ukraine and are provided by the WHO Commission “Codex Alimentarius” and the Joint FAO/WHO Meeting on Pesticide Residues (JMPR) were reviewed. The European Food Safety Authority (EFSA) project with the overall objective is to develop a database of validated processing factors based on the residue definitions for enforcement, which is compatible with the EFSA food classification and description system was outlined. The European Association of Plant Producers of the EU Vegetable Oil and Proteinmeal Industry (FEDIOL) position on pesticide MRLs in vegetable oils and fats were described. This concept has identified two main elements allowing to give an indication of the fat solubility of an substances. In particular, variants of interpretation of the octanol/water partition coefficient (log Pow) were analyzed. It can be used to predict whether the substance is fat - or water-soluble and to provides an estimate of the tendency of a active ingredients of pesticides to bioaccumulate in fat. In the case of vegetable oils, MRLs can be approximated based on the physico/chemical properties of the pesticides and on the oil content of the raw agricultural commodities (theoretical processing factors from oilseeds seed to oil). Conclusions. The review determines the necessity of improve Ukrainian pesticides regulation procedure and the development of a risk-oriented approach to the selection of priority indicators for the set of MRLs of pesticides in agricultural processed products. Key Words: pesticides, residues, processed products, oilseeds.

Scientific support for preparing an EU position in the 50th Session of the Codex Committee on Pesticide Residues (CCPR).

In accordance with Article 43 of Regulation (EC) 396/2005, EFSA received a request from the European Commission to provide support for the preparation of the EU position for 50th session of the Codex Committee on Pesticide Residues (CCPR). In 2017, Joint FAO/WHO Meeting on Pesticide Residues (JMPR) evaluated 15 active substances regarding the setting of toxicological reference values to be used in consumer risk assessment (bicyclopyrone, chlormequat, cyclaniliprole, fenazaquin, fenpropimorph, fenpyrazamine, fenpyroximate, fosetyl Al, isoprothiolane, natamycin, oxamyl, phosphonic acid, propylene oxide, thiophanate‐methyl, triflumezopyrim) and 36 substances for deriving maximum residue limit (MRL) proposals (acetamiprid, azoxystrobin, bicyclopyrone, captan, chlormequat, cyclaniliprole, cyprodinil, 2,4‐D, difenoconazole, fenazaquin, fenpropimorph, fenpyrazamine, fenpyroximate, flonicamid, fluensulfone, fluopyram, flupyradifurone, fosetyl Al, imazamox, imazapyr, imidacloprid, isoprothiolane, isopyrazam, natamycin, oxamyl, phosphonic acid, picoxystrobin, propiconazole, propylene oxide, prothioconazole, quinclorac, saflufenacil, spinetoram, tebuconazole, trifloxystrobin, triflumezopyrim); EFSA prepared comments on the Codex MRL proposals and the proposed toxicological reference values. In addition, EFSA provided the views on follow‐up assessments of JMPR on pesticides where specific concerns were raised in the previous CCPR meetings. The current report should serve as the basis for deriving the EU position for the CCPR meeting, relevant findings are summarised in this report.

Impact of proposed changes in IESTI equations for short-term dietary exposure to pesticides from Australian and Codex perspective

ABSTRACTIn 2015 a scientific workshop was held in Geneva, where updating the four equations for estimating the short-term dietary exposure (International Estimated Short Term Intake, IESTI) to pesticides was suggested. The impact of these proposed changes on the exposure was studied by using residue data and large portion consumption data from Codex and Australia. For the Codex data, the exposure increased by a median factor of 2.5 per commodity when changing to the proposed IESTI equations. The increase in exposure was highest for bulked and blended food commodities (case 3 equations), followed by medium-sized food commodities (case 2a equations) and small- and large-sized food commodities (case 1 and case 2b equations). For the Australian data, out of 184 maximum residue limit (MRL) large portion combinations showing acute exposures below the acute reference dose (ARfD) with the current IESTI equations, 23 exceeded the ARfD with the proposed IESTI equations (12%). The percentage exceeding the ARfD was higher for the Australian MRL large portion combinations (12% of 184) than for those of Codex (1.3% of 8,366). However, the percentage MRL loss in the Australian dataset may not be representative of all pesticide MRLs since it concerns six pesticides only, specifically selected to elucidate the potential effects of the use of the proposed IESTI equations. For the Codex data, the increase in exposure using the proposed equations resulted in a small increased loss of 2.6% of the 1,110 MRLs estimated by the Joint FAO/WHO Meeting on Pesticide Residues (JMPR): 1.4% of the MRLs were already not acceptable with the current equations, 4.0% of the MRLs were not acceptable with the newly proposed equations. Our study revealed that case 3 commodities may be impacted more by the proposed changes than other commodities. This substantiates one of the conclusions of the Geneva workshop to gather information on bulking and blending practices in order to refine MRL setting and dietary risk assessment for case 3 commodities where possible.

An assessment of the acute dietary exposure to glyphosate using deterministic and probabilistic methods

ABSTRACTUse of glyphosate in crop production can lead to residues of the active substance and related metabolites in food. Glyphosate has never been considered acutely toxic; however, in 2015 the European Food Safety Authority (EFSA) proposed an acute reference dose (ARfD). This differs from the Joint FAO/WHO Meeting on Pesticide Residues (JMPR) who in 2016, in line with their existing position, concluded that an ARfD was not necessary for glyphosate. This paper makes a comprehensive assessment of short-term dietary exposure to glyphosate from potentially treated crops grown in the EU and imported third-country food sources. European Union and global deterministic models were used to make estimates of short-term dietary exposure (generally defined as up to 24 h). Estimates were refined using food-processing information, residues monitoring data, national dietary exposure models, and basic probabilistic approaches to estimating dietary exposure. Calculated exposures levels were compared to the ARfD, considered to be the amount of a substance that can be consumed in a single meal, or 24-h period, without appreciable health risk. Acute dietary intakes were <100% of the ARfD for all foodstuffs, except wild fungi, when calculated using the EFSA model. The model assumptions differ from those of the source model (German national model), resulting in the use of a higher variability factor. Intakes estimated with the German model represented only 18% of the ARfD. The impact of differing assumptions regarding variability and other input parameters is discussed. Probabilistic exposure estimates showed that the acute intake on no person-days exceeded 10% of the ARfD, even for the pessimistic scenario.

Examining the feasibility of mixture risk assessment: A case study using a tiered approach with data of 67 pesticides from the Joint FAO/WHO Meeting on Pesticide Residues (JMPR)

The way in which mixture risk assessment (MRA) should be included in chemical risk assessment is a current topic of debate. We used data from 67 recent pesticide evaluations to build a case study using Hazard Index calculations to form risk estimates in a tiered MRA approach in line with a Framework proposed by WHO/IPCS. The case study is used to illustrate the approach and to add detail to the existing Framework, and includes many more chemicals than previous case studies.A low-tier MRA identified risk as being greater than acceptable, but refining risk estimates in higher tiers was not possible due to data requirements not being readily met. Our analysis identifies data requirements, which typically expand dramatically in higher tiers, as being the likely cause for an MRA to fail in many realistic cases. This forms a major obstacle to routine implementation of MRA and shows the need for systematic generation and collection of toxicological data. In low tiers, hazard quotient inspection identifies chemicals that contribute most to the HI value and thus require attention if further refinement is needed. Implementing MRA requires consensus on issues such as scope setting, criteria for performing refinement, and decision criteria for actions.

A review of the effect of different application rates on pesticide residue levels in supervised residue trials

Residue trial data reported by the Joint FAO/WHO Meeting on Pesticide Residues (JMPR) have been reviewed to establish whether or not the resulting residues in harvested commodities are proportional to the pesticide application rate used on the crop. Numerous sets of trials were identified where the only parameter varied was application rate or spray concentration. Analysis of this database in terms of application rate, spray concentration, formulation type, preharvest interval, crop, pesticide, residue level and application type confirms that residues scale with application rate (proportionality principle). It is anticipated that use of the proportionality principle by regulators and those interested in evaluating pesticide residue data will improve pesticide risk assessment.

A new tool for the evaluation of crop residue trial data (day-zero-plus decline)

An approach is presented for the prediction of pesticide residue concentrations in food and feed commodities produced from foliar-treated crops. It uses limited residue trial data and relies on information on spray retention and decline rates of residues following application. The use of the simple approach is demonstrated for residues of a variety of pesticides and the results compared with data sets evaluated by the Joint FAO/WHO Meeting on Pesticide Residues (JMPR) using expert judgement and also with estimates of high residues obtained using statistical methods. It is proposed that the approach should constitute an additional tool for the risk assessment of pesticide residues; it contributes to the estimation of maximum residue limits (MRLs) and high and median residues, which are needed for risk assessment. The approach should be particularly useful in situations where only a few residue trials are available such as often occurs for minor crops.

Microbiological Risk Assessment of foods in international trade

The international workshop on “Promotion of Technical Harmonisation on Risk-Based Decision Making” reviewed the use of risk-based decision making across a range of industry sectors and countries. This paper presents the contribution to the workshop covering microbiological risk assessment of foods in international trade. The format is a response to a set of questions prepared by the organisers of the workshop covering the use and performance of risk assessment, evaluation of the acceptability of the risk and the use of risk assessment in the decision-making process (see “Preface” of this special issue). Risk Assessment of foods has been developed for chemical hazards rather than for microbiological ones. Acceptable or tolerable levels of food additives and contaminants have been included in many food standards worldwide. As part of the FAO/WHO Food Standards programme, the Codex Alimentarius Commission has issued many such standards, based on recommendations from two FAO/WHO expert bodies, the Joint FAO/WHO Expert Committee on Food Additives and Contaminants (JECFA) and the Joint FAO/WHO Meeting on Pesticide Residues (JMPR). This need to establish Food Standards on Risk Assessment procedures was reinforced by the signing of the Uruguay Round of Multilateral Trade Negotiations, presently known as WTO Agreements. The agreement on Sanitary and Phytosanitary (SPS) measures put particular emphasis on the establishment of acceptable or tolerable levels for microorganisms important. The SPS text specified that science and risk assessment should be the basis for the determination of the safety of food. Food safety standards issued by Codex Alimentarius were mentioned as the reference, and Codex was also the preferred international body to develop methods for their establishment.

Acute intake assessment: evolution within the Codex Committee on Pesticide Residues

The Codex Committee on Pesticide Residues (CCPR), in its development of international standards, has been considering during the last few years the implications of residues of acutely toxic pesticides in food commodities. CCPR has asked its scientific advisory body, the Joint FAO/W HO Meeting on Pesticide Residues (JMPR), for advice on the safety of the standards that are being developed. This work began in 1993. The 1994 JMPR first decided to use the ‘acute reference dose’ as a toxicological benchmark for a ‘short-term ADI’. A number of acute reference doses have been allocated at subsequent meetings. The 1998 JMPR decided to consider the allocation of an acute reference dose whenever a full evaluation of a pesticide is undertaken. General guidance for the allocation of an acute reference dose was provided by the 1998 JMPR, which is discussed in this paper.

Background to the ADI/TDI/PTWI.

International scientific committees such as the Joint FAO/WHO Expert Committee on Food Additives (JECFA) and the Joint FAO/WHO Meeting on Pesticide Residues (JMPR), regional scientific committees such as those of the European Union, and national regulatory agencies generally use the safety factor approach for establishing acceptable or tolerable intakes of substances that exhibit thresholds of toxicity. The acceptable daily intake (ADI) is used widely to describe "safe" levels of intake; other terms that are used are the reference dose (RfD) and tolerable intakes that are expressed on either a daily (TDI or tolerable daily intake) or weekly basis. JECFA uses the term PTWI, or provisional tolerable daily intake, for contaminants that may accumulate in the body. The weekly designation is used to stress the importance of limiting intake over a period of time for such substances. When using this approach no-observed-effect levels (NOELs) or no-observed-adverse-effect levels (NOAELs) are identified in the critical studies, to which appropriate safety or uncertainty factors are applied. Although the value of safety factors varies depending upon a number of factors, 100 is most often used, which is designed to account for interspecies and intraspecies variations. Within the framework of the IPCS project on harmonization of approaches to the assessment of risk from exposure to chemicals, issues relating to uncertainty and variability are being addressed with the aim of relying, whenever appropriate, on data-derived safety/uncertainty factors. The ILSI Europe ADI Task Force has, for the past few years, been considering the scientific basis for the safety factor, which will be discussed by other speakers in the workshop. The value of the NOAEL is dependent on the design of the study. Because of the expense and time required conduct many studies, doses are usually spread over wide intervals. Thus, the no-observed-adverse-effect level may be considerably less than a marginally effective dose. In addition, use traditionally has not been made of the dose-response relationship when establishing ADIs. Newer approaches such as the benchmark dose may provide ways of making use of dose-response information. It is unlikely that consumption at the level of the ADI will result in significant risk to the consumer because of the conservatisms that are built into it. It usually is based on long-term studies that are intended to mimic consumption over the lifetime of humans. The ADI is applied to "discretionary" chemicals (food additives, veterinary drugs, and pesticides) by JECFA and JMPR, which are relatively easy to control if safety problems are identified. On the other hand, when tolerable intakes are derived for contaminants that are present in the environment at high levels, the use of standard safety factors could result in discarding large portions of the food supply. Thus, it is very important that the basis for the tolerable intake is fully described so that informed judgments can be made about the health consequences of exceeding it.

International safety assessment of pesticides: dithiocarbamate pesticides, ETU, and PTU--a review and update.

For the last 30 years the Joint FAO/WHO Meeting on Pesticide Residues (JMPR) has carried out toxicological evaluations and safety assessments of dithiocarbamate pesticides, continuously adjusting previous appraisals in the light of new data and advances in the understanding of the principles and mechanisms of toxic action of these compounds. The historical narrative of the evaluative process is followed by an account of the present international safety assessment status of the dithiocarbamate pesticides so far examined by the JMPR. They are ferbam, mancozeb, maneb, metiram, nabam, propineb, thiram, zineb, ziram, and the associated substances, ethylenethiourea (ETU) and propylenethiourea (PTU).

International safety assessment of pesticides: Dithiocarbamate pesticides, ETU, and PTU—A review and update

AbstractFor the last 30 years the Joint FAO/WHO Meeting on Pesticide Residues (JMPR) has carried out toxicological evaluations and safety assessments of dithiocarbamate pesticides, continuously adjusting previous appraisals in the light of new data and advances in the understanding of the principles and mechanisms of toxic action of these compounds. The historical narrative of the evaluative process is followed by an account of the present international safety assessment status of the dithiocarbamate pesticides so far examined by the JMPR. They are ferbam, mancozeb, maneb, metiram, nabam, propineb, thiram, zineb, ziram, and the associated substances, ethylenethiourea (ETU) and propylenethiourea (PTU). © 1996 Wiley‐Liss, Inc.

The Role of the World Health Organization in the Evaluation of Pesticides

The International Programme on Chemical Safety (IPCS), which is a cooperative program of the World Health Organization (WHO). United Nations Environment Programme (UNEP), and International Labour Organisation (ILO), directs a number of pesticide activities, including the WHO component of the Joint FAO/WHO Meeting on Pesticide Residues (JMPR) and the preparation of Environmental Health Criteria (EHC) documents and Health and Safety Guides (HSGs) on pesticides. The intake of pesticide residues is being predicted at the international level, which is based upon the maximum residue limits (MRLs) that are estimated by JMPR. Acceptance of the MRLs is increased when the prediction does not exceed the acceptable daily intake (ADI). IPCS is active in developing new methodologies and in developing scientific consensus documents on the assessment of health risks from exposure to chemicals. Two new initiatives are a project to obtain agreement among important national institutions on the approaches to be taken for the interpretation of data relating to specific effects and the development of a "Joint Meeting on Pesticides," which will provide comprehensive reviews of pesticide safety and use.

Codex Committee on Pesticide Residues—A plan for improved participation by governments

The Codex Committee on Pesticide Residues (CCPR), which is responsible for establishing maximum residue limits (MRLs) for pesticides on food, has a vital role in protecting the public health and facilitating international trade. Codex MRLs are based on scientific evaluations by expert panels that constitute the Joint FAO/WHO meeting on Pesticide Residues (JMPR). These panelists estimate an acceptable daily intake for a pesticide and expected level of residue remaining in food when the pesticide is used according to good agricultural practice. The goals of the CCPR are not being fully achieved. Governments are generally not accepting Codex MRLs; instead, technical and procedural aspects of the JMPR and CCPR process are being criticized. The CCPR is responding to valid criticisms of the process; however, governments may still lack the will to seek harmonization of pesticide limits for food in international trade. Overcoming this problem will be difficult, but not impossible. A plan of action is proposed that allows countries to selectively accept Codex MRLs, increase the number of chemicals in the JMPR CCPR system for evaluation, and be responsive to both their consumers and their food producers without compromising national health and safety standards and competitive trade advantages.