Assessment strategies and decision criteria for pesticides with endocrine disrupting properties relevant to humans.

There is growing concern that environmental substances with a potential to modulate the hormonal system may have harmful effects on human health. Consequently, a new EU regulation names endocrine disrupting properties as one of the cut-off criteria for the approval of plant protection products, although it currently fails to provide specific science-based measures for the assessment of substances with such properties. Since specific measures are to be presented by the European Commission in 2013 the development of assessment and decision criteria is a key challenge concerning the implementation of this new EU regulation. Proposals of such decision criteria for substances with potential endocrine disrupting properties in human health risk assessment were developed by the German Federal Institute for Risk Assessment (BfR) and discussed at an expert workshop in November 2009. Under consideration of the requirements laid down within the new plant protection product legislation and the scientific discussions during the workshop, a conceptual framework on evaluation of substances for endocrine disrupting properties in a regulatory context is presented in this paper. Central aspects of the framework include assessment of adversity of effects, establishment of a mode/mechanism of action in animals, considerations concerning the relevance of effects to humans and two options for a regulatory decision.

[Plant protection products and their residues : Aspects of consumer safety in context of the new EU regulations]. / Pflanzenschutzmittel und ihre Rückstände : Aspekte der Verbrauchersicherheit im Kontext neuer EU-Verordnungen.

The law regulating plant protection products (PPP) in the European Union (EU) was fundamentally revised through the introduction of Regulation (EC) No. 1107/2009 which is due to enter into force on 14 June 2011. EU-wide harmonized maximum residue levels (MRLs) for the active substances of PPP in foods are laid down in Regulation (EC) No. 396/2005 and apply since entry into force of the regulation on 1 September 2008. The goal of both regulations is to strengthen the level of consumer protection. PPP are subject to a strict assessment of active substances, which is regulated at the EU level as well as an authorization procedure in the EU Member States. Prior to application for authorization of a PPP, the active substance(s) it contains must be included in a positive list. Tests regarding the toxicity and residue behavior of PPP must be conducted by the applicant, and the respective documents must be submitted to the authorities for evaluation. Following review of the required data, toxicological threshold values are derived, consumer exposure is assessed, and the risk to health is evaluated. The goal of this evaluation is to ensure that the use of PPP according to good plant protection practice does not have any harmful effects on human health.

[Estimation of the dietary intake of pesticide residues based on new consumption data for children]. / Abschätzung der Aufnahme von Pflanzenschutzmittel-Rückständen in der Nahrung mit neuen. Verzehrsmengen für Kinder.

The risk assessment of pesticide residues is based on the estimation of their dietary intake. Models based on a new national consumption survey were developed to estimate the short- and long-term dietary intake of pesticide residues for children from 2 to under 5 years, allowing a realistic risk assessment to be made. The recommended methods are described. At the national level, the new models shall replace the previous methods for evaluating dietary intake.

[Comparative observations of the behavior of ethephon in fruit, coffee and paprika]. / Vergleichende Betrachtungen zum Rückstandsverhalten von Ethephon in Obst, Kaffee und Paprika.

After application of Flordimex to soft and stone fruit for fruit abscission and acceleration of ripening obvious Ethephon residues have been found. Therefore, the dose rate has to be restricted to keep the maximum residue limit. The same is true for the use of Flordimex for fruit abscission in apples, whereas for yield regulation residues are far below 0.05 mg/kg in apples. A typical feature of the active ingredient is the large quantity of its residues in juice and wine, which is as high as Ethephon concentration in fruits or even higher. Finally, Ethephon is demonstrated to enter the pulp of bananas, mandarin, grapefruit and mango as a result of treating harvested tropical fruit. The residue situation after treatment of pineapple, sweet pepper and coffee is discussed.

Toxicokinetics of the herbicide dichlorprop and its leucinate and their action on liver mixed function oxidase in rats.

The concentrations of dichlorprop and its leucine conjugate in serum and bile of rats have been determined at different periods after a single oral dosage of these compounds (30 or 300 mg/kg body weight). From the results it can be concluded that dichlorprop is excreted by active renal mechanisms resembling that described for 2,4,5-T. It is suggested that the leucinate is excreted more by the biliary route. Investigations of the liver demonstrate that both compounds are able to induce mixed function oxidases.

[Behavior of Ethephon residues on tomatoes. Part I. Green house tomatoes]. / Zum Rückstandsverhalten von Ethephon an Tomaten. 1. Mitt. Gewächshaustomaten.

The preparation Flordimex, which contains Ethephon (2-chloroethanephosphonic acid) as the active ingredient, is used for accelerating the ripening of tomatoes. During the years 1974--1977, tomato samples from 89 experiments were tested for Ethephon residues. The determination was performed gas chromatographically using alkali flame ionization detector as 2-chloroethanephosphonic acid dimethyl ester; the detection limit of the method was 0.01 mg/kg. The observed results must be evaluated on the basis of the permissible value (1 mg/kg) stipulated for vegetables by the Ministry of Health of the GDR. 1--2 days after the use of concentrations of 0.1%, 0.2%, 0.3% and 0.4%, respectively, the following mean residue values were found: 0.31, 0.50, 0.39 and 0.91 mg/kg, respectively, which decreased but slowly. This leads to the conclusion that formulation concentrations of more than 0.3% and applications of more than 6 1/ha should not be allowed by the Ministry. In case of repeated uses, 3-week intervals are imperative. Under the above-mentioned conditions of use, the mean residue values determined 4--5 days after application approximated 0.6 mg/kg. This period is to be regarded as a tentative waiting-period that must be respected after the treatment of glasshouse tomatoes with Flordimex.

[Occurrence of chlormequat (CCC) in wheat straw and its excretion in milk following feeding of straw pellets containing chlormequat]. / UPNTERSUCHUNGEN ZUM Vorkommen von Chlormequat (CCC) in Weizenstroh und seine Exkretion mit der Milch nach Verfütterung chlormequathaltiger strohpellets

When the herbicide chlormequat (chlorocholine chloride or CCC) was correctly used at 2 kg per hectare at the five-leaf stage of growth, the residues in wheat straw did not exceed 3 ppm. Such residual amounts remained unchanged after storage and pelleting. However, the feeding of contaminated straw pellets to cows did not result in contaimination of the milk detectable by a method which was capable of determining concentrations down to 0.05 ppm.