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Vol. 25 No. 5
September-October 2003

Making an imPACt | Recent IUPAC technical reports and recommendations that affect the many fields of pure and applied chemistry.
See also www.iupac.org/publications/pac
 

Significance of Impurities in the Safety Evaluation of Crop Protection Products

A. Ambrus, D. J. Hamilton, H. A. Kuiper, and K. D. Racke

Pure and Applied Chemistry
Vol. 75, No. 7, pp. 937-973 (2003)

Humans can be exposed to pesticides and their impurities through direct handling, re-entry of treated areas, contact with environmental residues, and dietary intake.

Technical pesticides, in addition to the "pure active ingredient," also may contain complex mixtures of other minor chemical components due to process variables, side reactions, and impurities in starting materials. The impurities may contribute to the toxicity of the pesticide or may alter the physical properties of the product. For some impurities this may lead to the allocation of maximum concentration limits in technical grade products.

The toxicological tests carried out with technical products of typical composition for registration purposes include assessment of toxic potency of the impurities present in the test material. However, the composition of the technical product may vary, particularly with respect to impurities and potentially also the toxicity of the product, depending on the manufacturing process and sources of starting materials. The use of various adjuvants and carrier materials in the preparation of the formulation may also result in marked differences in storage stability of formulations. This is especially of concern in the case of generic pesticides, which may be produced and formulated by many manufacturers under widely varying conditions, with different materials, and under a range of quality control standards.

Because of the confidential nature of the information on impurities in technical pesticides, this report cannot provide comprehensive coverage of the extremely diverse subject. Rather, published examples are given to illustrate possible scenarios and support the conclusions and recommendations made This report is aimed at improving the safety assessment of crop protection products by focusing on the nature and effects of certain impurities. Recommendations are provided to government authorities considering the establishment or revision of their pesticide registration and compliance programs to ensure the safe and efficient use of pesticides. Guidance is also given for the correct assessment of impurities in technical grade and formulated pesticide products based on the technical documentation provided by the manufacturer, appropriate utilization of FAO Specifications of Plant Protection Products, and the toxicological evaluations made by the FAO/WHO Joint Meeting on Pesticide Residues. The importance of regular control of relevant impurities during the manufacturing and formulating processes as well as during storage and handling of marketed products is highlighted.

www.iupac.org/publications/
pac/2003/7507/7507x0937.html


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