Acute Exposure Assessment Research Articles

Scientific support for preparing an EU position in the 44th Session of the Codex Committee on Pesticide Residues (CCPR)

Scientific support for preparing an EU position in the 44th Session of the Codex Committee on Pesticide Residues (CCPR)

Evaluation of a biomarker for assessment of acute acrylonitrile exposure in humans

Evaluation of a biomarker for assessment of acute acrylonitrile exposure in humans

Reasoned opinion on the modification of the existing MRLs for teflubenzuron in various fruiting vegetables

Reasoned opinion on the modification of the existing MRLs for teflubenzuron in various fruiting vegetables

Brazilian monitoring programs for pesticide residues in food – Results from 2001 to 2010

A total of 13,556 samples of 22 fruit and vegetable crops, rice, and beans were analyzed within two Brazilian pesticide residue monitoring programs between 2001 and 2010. Pesticide residues were found in 48.3% of the samples, and 13.2% presented some irregularity, mostly non-authorized active ingredient use. Less than 3% of the samples had residue levels above the MRL. Apple, papaya, sweet pepper and strawberry were the crops with the higher percentages of positive samples (about 80%). Dithiocarbamates and organophosphorus compounds were found in 41.6% and 30.8% of the samples, respectively. Carbendazim and chlorpyrifos were the pesticides most found (26.7 and 16.1% of positive samples, respectively). Almost half of the samples analyzed had multiple residues (up to 10 residues), with multiple residues most common in samples of apple, sweet pepper and tomato. About 8% of positive samples contained up to four residues of the same chemical class, mainly organophosphorus compounds (18.6%, mostly in apple) and triazoles (16.1%, mostly in papaya and grape). In general, the scenario of pesticide residues in foods investigated within the Brazilian governmental monitoring programs in the last decade is similar to what has been found in other countries. However, the use of non-authorized active ingredients is a common practice among the farmers in the country, a problem that the government authorities have been trying to solve. A preliminary cumulative acute exposure assessment for organophosphates and carbamates in apple has shown that the intake by individuals ≥10 years old accounts for 100% of the acephate ARfD, indicating a need to further investigate the exposure through the consumptions of other crops and group of pesticides, mainly for children.

Probabilistic acute dietary exposure assessment of the Chinese population to cypermethrin residues

A probabilistic estimation of dietary exposure to cypermethrin residues for the Chinese population was performed. Cypermethrin residue data were obtained from the national food contamination monitoring program for 2001–2006, encompassing 14,096 samples from 36 commodities with a detection rate of 10.4%. Food consumption data were gathered from the national nutrition and health survey conducted in 2002, comprising 65,915 consumers aged 2–100 years and 3701 children of 2–6 years old. The whole country was roughly divided into six regions and the ranges of the median and of P99.9 exposure estimated for these regions were 0.018–0.026 and 3.131–7.095 µg kg−1 bw day−1, respectively. Pak-choi and Chinese cabbage contributed 33.9 and 13.2%, respectively, to the cypermethrin intake for the general population, while pak-choi and citrus covered 30.7 and 22.5% of the total intake for children, respectively. The exposure of the rural population was higher than urban populations. Rural areas mainly located in the plains of central China had among the highest exposure of the six regions, accounting for 17.7% of the ARfD at P99.9, while the 99.99th percentile of exposure for children, especially rural children, far exceeded the ARfD, which is a cause for concern.

Modification of the existing MRLs for dimethomorph in various commodities

Modification of the existing MRLs for dimethomorph in various commodities

Modification of the existing MRLs for difenoconazole in beet leaves (chard), globe artichokes, broccoli, cardoons and strawberries

Modification of the existing MRLs for difenoconazole in beet leaves (chard), globe artichokes, broccoli, cardoons and strawberries

Modification of the current MRLs for acetamiprid in flowering brassica and figs

Modification of the current MRLs for acetamiprid in flowering brassica and figs

A Preliminary Risk Assessment of Human Exposure to Phycotoxins in Shellfish: A Review

ABSTRACT Over the past few decades, phycotoxins, secondary metabolites produced by toxic phytoplankton, have seen an increase in their frequency, concentrations, and geographic distribution. As shellfish accumulate phycotoxins making them unfit for human consumption, they are considered as an important food safety issue. Thus, a consumer exposure assessment on phycotoxins is necessary. Exposure assessment requires two types of information: contamination and consumption data. Shellfish contamination data on major toxins encountered by at-risk populations (Domoic Acid group, Okadaic Acid group, and Saxitoxin group) have been reviewed. Consumption data have been reviewed for both general and potential high-consumer populations. Then, we undertook acute and chronic exposure assessments, combining available French contamination data and our own consumption data. Studies including exposure assessment were then reviewed. Lastly, risk characterization was undertaken. It can be concluded that both acute and chronic exposure to phycotoxins via shellfish consumption is a matter of concern, mainly for high consumers identified in this review (specific populations and shellfish harvesters). However, the results for risk characterization must be improved. There is a need for (i) toxicological data to establish a Tolerable Daily Intake; (ii) an assessment of consumption and contamination data, undertaken at the same time, so as to assess exposure.

Setting of temporary MRLs for nicotine in tea, herbal infusions, spices, rose hips and fresh herbs

EFSA JournalVolume 9, Issue 3 2098 Reasoned OpinionOpen Access Setting of temporary MRLs for nicotine in tea, herbal infusions, spices, rose hips and fresh herbs European Food Safety Authority, European Food Safety AuthoritySearch for more papers by this author European Food Safety Authority, European Food Safety AuthoritySearch for more papers by this author First published: 04 March 2011 https://doi.org/10.2903/j.efsa.2011.2098Citations: 11 Correspondence: praper.mrl@efsa.europa.eu Acknowledgement: EFSA wishes to thank the Assessment Methodology Unit (AMU) of EFSA for the preparatory work on this scientific output. Approval date: 2 March 2011 Published date: 4 March 2011 Question number: EFSA-Q-2011-00027 On request from: European Commission AboutPDF ToolsExport citationAdd to favoritesTrack citation ShareShare Give accessShare full text accessShare full-text accessPlease review our Terms and Conditions of Use and check box below to share full-text version of article.I have read and accept the Wiley Online Library Terms and Conditions of UseShareable LinkUse the link below to share a full-text version of this article with your friends and colleagues. Learn more.Copy URL Share a linkShare onFacebookTwitterLinkedInRedditWechat References Andersson, C., Weenström, P., Gry, J., 2003. Nicotine alkaloids in Solanaceous food plants, TemaNord 2003:531. CEN (European Committee for Standardization), 2008. Foods of plant origin - Determination of pesticide residues using GC-MS and/or LC-MS/MS following acetonitrile extraction/partitioning and clean-up by dispersive SPE. QuEChERS-method. EN EN 15662.2008. November 2008. EC (European Commission), 2004. Residue analytical methods. For post-registration control. SANCO/825/00-rev.7. Available from: ec.europa.eu/food/plant/protection/resources/publications_en.htm. EC (European Commission), 2008. Appendix D. Guidelines on comparability, extrapolation, group tolerances and data requirements for setting MRLs. 7525/VI/95-rev.8. Available from: ec.europa.eu/food/plant/protection/resources/publications_en.htm. EC (European Commission), 2010. Classes to be used for the setting of EU pesticide Maximum Residue Levels (MRLs). SANCO 10634/2010 Rev. 0, finalized in the Standing Committee on the Food Chain and Animal Health at its meeting of 23–24 March 2010. EFSA (European Food Safety Authority), 2009. EFSA Statement on Potential risks for public health due to the presence of nicotine in wild mushrooms. EFSA Journal 2009; RN-286, pp. 1– 47. EFSA (European Food Safety Authority), 2007. Pesticide Residues Intake Model for assessment of acute and chronic consumer exposure to pesticide residues-rev.2. Available from www.efsa.europa.eu/en/mrls/mrlteam.htm. EURL (EU Reference Laboratories for Residues of Pesticides), 2010. Analysis of Nicotine in Mushrooms. www.crl-pesticides.eu/library/docs/srm/meth_NicotineMushrooms_CrlFvCrlSrm.pdf. ETC/EHIA (European Tea Committee, European Herbal Infusions Association), 2010. Letter to the European Commission on Pesticide residue regulation (EC) No 396/2005: Nicotine. Hamburg, 13 September 2010. ETC/EHIA (European Tea Committee, European Herbal Infusions Association), 2011. Letter to the European Commission on additional information on nicotine in tea and herbal infusions. Hamburg, 18 September 2011. FAO (Food and Agriculture Organization of the United Nations), 2009. Submission and evaluation of pesticide residues data for the estimation of Maximum Residue Levels in food and feed. Pesticide Residues. 2nd Ed. FAO Plant Production and Protection Paper 197, 264 pp. Lindgren M., Molander L., Verbaan C, $$Lunell E., Rosén I., 1991. Electroencephalographic effects of intravenous nicotine – a dose-response study Psychopharmacology 145: 342– 350. Mersch-Sundermann, V.H., 2010. Risikobewertung: Nikotin in Teeprodukten, Institut für Umweltmedizin und Krankenhaushygiene, Department of Environmental Health Sciences, Universitätsklinikum Freiburg, 13.7-2010. The United Kingdom, 2007. Draft assessment report on the active substance nicotine prepared by the rapporteur Member State The United Kingdom in the framework of Council Directive 91/414/EEC, December 2007. Citing Literature Volume9, Issue3March 20112098 ReferencesRelatedInformation

Modification of the existing MRLs for kresoxim‐methyl in blueberries and cranberries

Modification of the existing MRLs for kresoxim‐methyl in blueberries and cranberries

Modification of the existing MRL for novaluron in cranberries

EFSA JournalVolume 8, Issue 12 1963 Reasoned OpinionOpen Access Modification of the existing MRL for novaluron in cranberries European Food Safety Authority, European Food Safety AuthoritySearch for more papers by this author European Food Safety Authority, European Food Safety AuthoritySearch for more papers by this author First published: 21 December 2010 https://doi.org/10.2903/j.efsa.2010.1963Citations: 2 Correspondence: praper.mrl@efsa.europa.eu Approval date: 16 December 2010 Published date: 21 December 2010 Question number: EFSA-Q-2010-01054 On request from: European Commission AboutPDF ToolsExport citationAdd to favoritesTrack citation ShareShare Give accessShare full text accessShare full-text accessPlease review our Terms and Conditions of Use and check box below to share full-text version of article.I have read and accept the Wiley Online Library Terms and Conditions of UseShareable LinkUse the link below to share a full-text version of this article with your friends and colleagues. Learn more.Copy URL Share a linkShare onFacebookTwitterLinkedInRedditWechat References EC (European Commission), 1996. Appendix G. Livestock Feeding Studies. 7031/VI/95 rev.4. Available from: ec.europa.eu/food/plant/protection/resources/publications_en.htm. EC (European Commission), 1997a. Appendix A. Metabolism and distribution in plants. 7028/IV/95-rev.3. Available from: ec.europa.eu/food/plant/protection/resources/publications_en.htm. EC (European Commission), 1997b. Appendix B. General recommendations for the design, preparation and realization of residue trials. Annex 2. Classification of (minor) crops not listed in the Appendix of Council Directive 90/642/EEC. 7029/VI/95-rev.6. Available from: ec.europa.eu/food/plant/protection/resources/publications_en.htm. EC (European Commission), 1997c. Appendix C. Testing of plant protection products in rotational crops. 7524/VI/95-rev.2. Available from: ec.europa.eu/food/plant/protection/resources/publications_en.htm. EC (European Commission), 1997d. Appendix E. Processing studies. 7035/VI/95-rev.5. Available from: ec.europa.eu/food/plant/protection/resources/publications_en.htm. EC (European Commission), 1997e. Appendix F. Metabolism and distribution in domestic animals. 7030/VI/95-rev. 3. Available from: ec.europa.eu/food/plant/protection/resources/publications_en.htm. EC (European Commission), 1997f. Appendix H. Storage stability of residue samples. 7032/VI/95-rev.5. Available from: ec.europa.eu/food/plant/protection/resources/publications_en.htm. EC (European Commission), 1997g. Appendix I. Calculation of maximum residue level and safety intervals. 7039/VI/95. As amended by the document: classes to be used for the setting of EU pesticide maximum residue levels (MRLs). SANCO 10634/2010. Available from: ec.europa.eu/food/plant/protection/resources/publications_en.htm. EC (European Commission), 2000. Residue analytical methods. For pre-registration data requirement for Annex II (part A, section 4) and Annex III (part A, section 5 of Directive 91/414. SANCO/3029/99-rev.4. Available from: ec.europa.eu/food/plant/protection/resources/publications_en.htm. EC (European Commission), 2004. Residue analytical methods. For post-registration control. SANCO/825/00-rev.7. Available from: ec.europa.eu/food/plant/protection/resources/publications_en.htm. EC (European Commission), 2008. Appendix D. Guidelines on comparability, extrapolation, group tolerances and data requirements for setting MRLs. 7525/VI/95-rev.8. Available from: ec.europa.eu/food/plant/protection/resources/publications_en.htm. EC (European Commission), 2010. Classes to be used for the setting of EU pesticide Maximum Residue Levels (MRLs). SANCO 10634/2010 Rev. 0, finalized in the Standing Committee on the Food Chain and Animal Health at its meeting of 23–24 March 2010. Available from: ec.europa.eu/food/committees/regulatory/scfcah/phytopharmaceuticals/sum_2324032010_en.pdf. EFSA (European Food Safety Authority), 2007. Pesticide Residues Intake Model for assessment of acute and chronic consumer exposure to pesticide residues-rev.2. Available from www.efsa.europa.eu/en/mrls/mrlteam.htm. FAO (Food and Agriculture Organization of the United Nations), 2005. Novaluron. In: Pesticide residues in food-2005. Evaluations. Part II. Toxicology. World Health Organization, WHO/IPCS/93.34. The United Kingdom, 2005. Draft assessment report on the active substance novaluron prepared by the rapporteur Member State the United Kingdom in the framework of Council Directive 91/414/EEC, September 2005. The United Kingdom, 2007. DG Sanco Experts meeting Annexes Reg. 396/2005 – May, June, September 2007 and 2nd round 28–31 January 2008. The United Kingdom, 2010. Evaluation report on the modification of MRL for novaluron in cranberries prepared by the evaluating Member State the United Kingdom under Article 8 of Regulation (EC) No 396/2005, 10 June 2010, [ 32 pp.]. Citing Literature Volume8, Issue12December 20101963 ReferencesRelatedInformation

Design and preparation of market baskets of European Union commercial baby foods for the assessment of infant exposure to food chemicals and to their effects

The assessment of acute and chronic dietary exposure to contaminants in baby foods is needed to ensure healthy infant growth. Monthly European Union market baskets of commercial baby foods were designed for the first 9 months of life by the ‘babyfood’ study group of the CASCADE Network of Excellence for the specific purpose of assessing exposure to potentially toxic substances in infants fed with such foods. The present paper reports the different steps that led to the preparation of monthly pooled samples of commercial baby foods (‘Infant formulae and follow-on formulae’ and ‘Other baby foods’) that may constitute the extreme case of the diet for an infant who would not be breast fed at all. Several market baskets were generated for an ‘average European Union infant’ and for infants of four selected countries (Italy, Sweden, Spain, and the Slovakia), fed with either milk infant formulae, soy infant formulae or hypoallergenic infant formulae and weaned (at the fifth month) with commercial baby foods and beverages available on the European Union market. Market share data for 2007 for baby foods were used to design the baskets. Holding companies and the name of all their products were identified. Monthly diets for European Union infants were elaborated in terms of food categories (e.g. infant cereals) of typologies of products (e.g. infant cereals without gluten) and of a specific product. The number of baskets generated was 30 for ‘Infant formulae and follow-on formulae’ (including 62 products) and 13 for ‘Other baby foods’ (including 35 products). These market baskets were designed to be used for the determination of certain contaminants and nutrients in the diet of European Union infants and for the assessment of their effects on infant health.

Air Monitoring and Assessment of Occupational Exposure to Peracetic Acid in a Hospital Environment

A new automated method based upon solid phase micro-extraction (SPME)/fast gas chromatography-mass spectrometry (GC-MS) was developed for the quantitative determination of airborne peracetic acid (PAA). The method is suitable for the quick assessment of brief acute exposure as well as for long-term environmental monitoring of PAA and can assist in improving safety and environmental quality in workplaces where disinfectants are used. During a monitoring campaign in the Regional Hospital of Florence, Italy, the 8-h average air concentration of PAA was 1/10 of the threshold limit value of time weighted average in 87% of the clinical units tested. However, the application of the new SPME method showed that short-term exposure to PAA could be relatively elevated in some hospital units with poor ventilation, allowing prompt intervention in order to reduce worker exposure to this potentially toxic compound.

Probabilistic assessment of the cumulative dietary acute exposure of the population of Denmark to organophosphorus and carbamate pesticides

Organophosphorus and carbamate pesticides are acetylcholinesterase-inhibiting pesticides and as such have a common mode of action. We assessed the cumulative acute exposure of the population of Denmark to 25 organophosphorus and carbamate pesticide residues from the consumption of fruit, vegetables and cereals. The probabilistic approach was used in the assessments. Residue data obtained from the Danish monitoring programme carried out in the period 2004–2007, which included 6704 samples of fruit, vegetables and cereals, were used in the calculations. Food consumption data were obtained from the nationwide dietary survey conducted in 2000–2002. Contributions from 43 commodities were included in the calculations. We used the relative potency factor (RPF) approach to normalize the toxicity of the various organophosphorus and carbamate pesticides to the two index compounds chlorpyriphos and methamidophos. RPF values derived from the literature were used in the calculations. We calculated the cumulative acute exposure to 1.8% and 0.8% of the acute reference dose (ARfD) of 100 µg kg–1 body weight (bw) day–1 of chlorpyrifos as an index compound at the 99.9th percentile (P99.5) for children and adults, respectively. When we used methamidophos as the index compound, the cumulative acute intakes were calculated to 31.3% and 13.8% of the ARfD of 3 µg kg–1 bw day–1 at P99.9 for children and adults, respectively. With both index compounds, the greatest contributor to the cumulative acute exposure was apple. The results show that there is no cumulative acute risk for Danish consumers to acetylcholinesterase-inhibiting pesticides.

Iodomethane human health risk characterization

Iodomethane is a new pre-plant soil fumigant approved in the United States. Human exposure may occur via inhalation due to the high vapor pressure of iodomethane. A quantitative human health risk assessment was conducted for inhalation exposure. The critical effects of acute duration iodomethane exposure are: (1) fetal losses in rabbits, (2) lesions in rat nasal epithelium, and (3) transient neurotoxicity in rats. Chronic exposure of rats resulted in increased thyroid follicular cell tumors from sustained perturbation of thyroid hormone homeostasis. A physiologically based pharmacokinetic (PBPK) model for iodomethane was developed to characterize potential human health effects from iodomethane exposure. The model enabled calculation of human equivalent concentrations (HECs) to the animal no-observed-adverse-effect levels (NOAELs) using chemical-specific parameters to determine the internal dose instead of default assumptions. Iodomethane HECs for workers and bystanders were derived using the PBPK model and NOAELs for acute exposure endpoints of concern. The developmental endpoint NOAEL was 10 ppm and corresponding bystander HEC was 7.4 ppm. The nasal endpoint NOAEL was 21 ppm and the HEC was 4.5 ppm. The transient neurotoxicity endpoint NOAEL was 27 ppm and the HEC was10 ppm. Data demonstrated that humans are less sensitive to the effect that causes developmental toxicity in rabbits and the PBPK model incorporated this information, resulting in a higher HEC for the developmental endpoint than for the nasal endpoint. Nasal olfactory degeneration is the primary endpoint for risk assessment of acute exposure to iodomethane.

The role of developmental toxicity studies in acute exposure assessments: Analysis of single-day vs. multiple-day exposure regimens

In accordance with most toxicity guidelines, developmental studies typically utilize repeated exposures, usually throughout gestation or during organogenesis in particular. However, it is known that developmental toxicity may occur in response to single exposures, especially during specific windows of susceptibility. An overview of the available literature gave sufficient evidence that for many agents, the same endpoints observed in repeated dose, multiple-day studies were also observed in single-day exposures, thus indicating the relevance of developmental toxicity to health assessments of acute exposures. Further, results of benchmark dose modeling of developmental endpoints indicated that for embryo lethality, single-day exposures required a two- to fourfold higher dose than the multiple-day exposures to produce the same level of response. For fused sternebrae, exposures on specific days produced equivalent levels of response at doses that were more similar to those utilized in the repeated exposures. Appreciable differences in biological half-life (and corresponding dose metrics) as well as specific windows of susceptibility may partially explain the observed multiple- vs. single-day exposure dose–response relationships. Our results highlight the need of a more thorough evaluation of outcomes from repeated dose developmental toxicity studies in regards to their importance to chronic and acute risk assessments.

Probabilistic acute dietary exposure assessments to captan and tolylfluanid using several European food consumption and pesticide concentration databases

Probabilistic dietary acute exposure assessments of captan and tolylfluanid were performed for the populations of the Czech Republic, Denmark, Italy, the Netherlands and Sweden. The basis for these assessments was national databases for food consumption and pesticide concentration data harmonised at the level of raw agricultural commodity. Data were obtained from national food consumption surveys and national monitoring programmes and organised in an electronic platform of databases connected to probabilistic software. The exposure assessments were conducted by linking national food consumption data either (1) to national pesticide concentration data or (2) to a pooled database containing all national pesticide concentration data. We show that with this tool national exposure assessments can be performed in a harmonised way and that pesticide concentrations of other countries can be linked to national food consumption surveys. In this way it is possible to exchange or merge concentration data between countries in situations of data scarcity. This electronic platform in connection with probabilistic software can be seen as a prototype of a data warehouse, including a harmonised approach for dietary exposure modelling.

Genotoxicity assessment of acute exposure of chlorpyrifos to freshwater fish Channa punctatus (Bloch) using micronucleus assay and alkaline single-cell gel electrophoresis

Chlorpyrifos (O,O-diethyl O-3,5,6-trichloro-2-pyridylphosphorothioate) is one of the organophosphate pesticides widely used in agricultural practices throughout world and irreversible inhibitor of cholinesterase in all animal species. Limited efforts have been made to study acute genotoxic effects of chlorpyrifos (CPF) in different tissues of fish using genotoxic biomarkers. Therefore, the present investigation was aimed to study the induction of DNA damage by CPF in freshwater teleost fish Channapunctatus using micronucleus assay (MN assay) and alkaline single-cell gel electrophoresis (comet assay). The value of LC50 – 96h of CPF was determined as 811.98μgl−1 for C. punctatus, in a semi-static system and on the basis of LC50 value three acute concentrations viz., 203, 406 and 609μgl−1 were determined. The fishes were exposed to the different concentrations of CPF for 96h and samplings were done at regular intervals for assessment of the MN frequencies and DNA damage. In general, significant effects (P<0.01) from both concentrations and time of exposure were observed in exposed fishes. It was found that the micronucleus induction was highest on 96h at all concentrations in the peripheral blood. Similar trend was observed for the DNA damage measured in terms of the percentage of tail DNA in the lymphocyte and gill cells. This study explored the combined use of micronucleus assay and comet assay for in vivo laboratory studies using fresh water fish for screening the genotoxic potential of xenobiotics.

Laboratory diagnosis of toluene-based inhalants abuse

Toluene is the main substance contained in products used as inhalants. The frequent abuse of toluene-based inhalants requires the definition of a simple laboratory parameter that allows acute exposure assessment. This study aimed at defining urinary hippuric acid (UHA) levels related to intentional exposure to toluene, and to correlate them to blood toluene concentration (BT). Methods. BT and UHA levels were measured in 65 homeless adolescents of Porto Alegre, Brazil. Results. Toluene was detected in 91.9% of the investigated population, who presented BT levels from 0.5 to 83.7 μg/mL. There was good correlation between UHA and BT concentrations (r = 0.78), and in homeless adolescents, UHA levels higher than 3.0 g/g creatinine indicate intentional exposure to toluene. Conclusions. The determination of UHA concentrations can be used as a screening method for the detection of intentional exposure to toluene, but its diagnosis must include BT toluene dosage, as well as circumstantial and clinical evidence.