Challenges and Opportunities in the Global Regulation of Crop Protection Products

Crop protection active ingredients and formulated products are essential tools for modern agriculture that serve to prevent yield loss related to insect, weed, or fungal pest pressure. Prior to commercialization, crop protection products must be authorized or registered across various regulatory jurisdictions globally. Registration decisions are based on the results of comprehensive testing requirements across multiple scientific disciplines. Full characterization of physical/chemical properties must be conducted, and specifications must be put in place for active ingredient purity and impurity levels. Additionally, studies to assess fate, behavior, and transformation in relevant environmental matrices are conducted. Hazard properties are identified by conducting multiple toxicology studies utilizing in vitro test systems as well as relevant invertebrate and vertebrate species. Hazard end points derived from these studies are then assessed relative to the exposure potential of the chemical obtained throug...

[1]  Erich-Christian Oerke,et al.  Safeguarding production-losses in major crops and the role of crop protection , 2004 .

[2]  R Kroes,et al.  The threshold of toxicological concern concept in risk assessment. , 2005, Toxicological sciences : an official journal of the Society of Toxicology.

[3]  A. Garrison Probing the enantioselectivity of chiral pesticides. , 2006, Environmental science & technology.

[4]  Meiqing Jin,et al.  Enantioselective phytoeffects of chiral pesticides. , 2009, Journal of agricultural and food chemistry.

[5]  S. Robinson,et al.  Food Security: The Challenge of Feeding 9 Billion People , 2010, Science.

[6]  J. Gan,et al.  Chirality of organophosphorus pesticides: analysis and toxicity. , 2010, Journal of chromatography. B, Analytical technologies in the biomedical and life sciences.

[7]  Ian Indans,et al.  Acute toxicity testing of chemicals—Opportunities to avoid redundant testing and use alternative approaches , 2010, Critical reviews in toxicology.

[8]  C. Mora,et al.  How Many Species Are There on Earth and in the Ocean? , 2011, PLoS biology.

[9]  S. Carpenter,et al.  Solutions for a cultivated planet , 2011, Nature.

[10]  T. Ward,et al.  Chiral separations: a review of current topics and trends. , 2012, Analytical chemistry.

[11]  Malin Lindstedt,et al.  The GARD assay for assessment of chemical skin sensitizers. , 2013, Toxicology in vitro : an international journal published in association with BIBRA.

[12]  T. Sparks,et al.  Insecticide discovery: an evaluation and analysis. , 2013, Pesticide biochemistry and physiology.

[13]  Ruili Huang,et al.  Using in Vitro High Throughput Screening Assays to Identify Potential Endocrine-Disrupting Chemicals , 2012, Environmental health perspectives.

[14]  L. Gianessi,et al.  The increasing importance of herbicides in worldwide crop production. , 2013, Pest management science.

[15]  David Dreher,et al.  Can acute dermal systemic toxicity tests be replaced with oral tests? A comparison of route-specific systemic toxicity and hazard classifications under the Globally Harmonized System of Classification and Labelling of Chemicals (GHS). , 2013, Regulatory toxicology and pharmacology : RTP.

[16]  Angelo Moretto,et al.  Risk assessment in the 21st century: Roadmap and matrix , 2014, Critical reviews in toxicology.

[17]  S. Gehen,et al.  Application of the KeratinoSens™ assay for assessing the skin sensitization potential of agrochemical active ingredients and formulations. , 2015, Regulatory toxicology and pharmacology : RTP.

[18]  Jing Ye,et al.  Enantioselective environmental toxicology of chiral pesticides. , 2015, Chemical research in toxicology.

[19]  S. Gehen,et al.  GHS additivity formula: A true replacement method for acute systemic toxicity testing of agrochemical formulations. , 2016, Regulatory toxicology and pharmacology : RTP.

[20]  B. Gámiz,et al.  Evidence for the effect of sorption enantioselectivity on the availability of chiral pesticide enantiomers in soil. , 2016, Environmental pollution.

[21]  Manoj Aggarwal,et al.  Implementing a framework for integrating toxicokinetics into human health risk assessment for agrochemicals. , 2016, Regulatory toxicology and pharmacology : RTP.

[22]  Ralf J. M. Weber,et al.  Applying 'omics technologies in chemicals risk assessment: Report of an ECETOC workshop. , 2017, Regulatory toxicology and pharmacology : RTP.

[23]  S. Gehen,et al.  A retrospective analysis of in vivo eye irritation, skin irritation and skin sensitisation studies with agrochemical formulations: Setting the scene for development of alternative strategies , 2017, Regulatory toxicology and pharmacology : RTP.

[24]  D. Carrão,et al.  Metabolism studies of chiral pesticides: A critical review. , 2018, Journal of pharmaceutical and biomedical analysis.

[25]  Mary D. Evenson,et al.  Analytical Chemistry: A Crucial Tool in Process Development for New Agricultural Active Ingredients , 2019, Organic Process Research & Development.