This document presents the outcomes of the 3rd OECD Biopesticide Seminar, held in 2011, that focused on the topic of “botanicals” (also known as plant extracts). The Seminar reviewed a number of scientific and regulatory issues related to the “characterisation and analyses of botanicals for the use in plant protection products”.
The OECD Environmental Risk Assessment Toolkit describes the work flow for environmental risk assessment and management of chemicals with links to available OECD material relevant for the different steps in risk assessment and management. This new version of the Toolkit is more interactive and has added functionalities. It will be populated with additional tools and case studies in the future.
The aquatic life benchmarks (for freshwater species) are based on toxicity values reviewed by EPA and used in the Agency's most recent risk assessments developed as part of the decision-making process for pesticide registration. Each Aquatic Life Benchmark is based on the most sensitive, scientifically acceptable toxicity endpoint available for a given taxon of all scientifically acceptable toxicity data available to EPA.
The new Test Guidelines are: TG 457 and TG 460. The updated Test Guidelines are TG 109, TG 114, TG 229, TG 211, TG 305, TG 455, and TG 405. The corrected Test Guideline is TG 443
English, PDF, 1,097kb
This brochure (version: October 2012) presents the activities of the OECD "Working Group on Harmonisation of Regulatory Oversight in Biotechnology" and the "Task Force for the Safety of Novel Foods and Feeds”.
This Test Guideline describes an in vitro assay, which provides concentration-response data for substances with in vitro ER agonist and antagonist activity. The test system utilises the BG1Luc4E2 cell line derived from a human ovarian adenocarcinoma and stably transfected with a ER responsive luciferase reporter gene. This cell line can evaluate TA mediated by ER alpha and ER beta. The cells are plated into 96-well plate and exposed to 7 (range finder tests) and 11 (comprehensive test) non-cytotoxic concentrations of the test chemical for 19-24 hours to induce the reporter gene product (luciferase). Its activity is measured in a luminometer. Acceptance or rejection of a test is based on the evaluation of reference standard and control results from each experiment conducted on a 96-well plate. A positive response is identified by a concentration–response curve containing at least three points with non-overlapping error bars, as well as a change in amplitude (normalized relative light unit) of at least 20 % of the maximal value for the reference substance (17beta-estradiol for the agonist assay, raloxifene HCL/ 17beta-estradiol for the antagonist assay).
This Performance-Based Test Guideline (PBTG) describes in vitro assays, which provides the methodology of Stably Transfected Transactivation to detect Estrogen Receptor Agonists (ER TAs). It comprises mechanistically and functionally similar test methods for the identification of estrogen receptor agonists and should facilitate the development of new similar or modified test methods. The two reference test methods that provide the basis for this PBTG are: the Stably Transfected TA (STTA) assay using the (h) ERá-HeLa-9903 cell line, derived from a human cervical tumor, and the BG1Luc ER TA assay using the BG1Luc-4E2 cell line, derived from a human ovarian adenocarcinoma. The cell lines used in these assays express ER and have been stably transfected with an ER responsive luciferase reporter gene. The assays are used to identify chemicals that activate the ER following ligand binding, after which the receptor-ligand complex binds to specific DNA response elements and transactivates the reporter gene, resulting in increased cellular expression of a marker enzyme (e.g. luciferase in luciferase based systems). The enzyme then transforms the substrate to a bioluminescent product that can be quantitatively measured with a luminometer.These test methods are being proposed for screening and prioritisation purposes, but also provide mechanistic information that can be used in a weight of evidence approach.
This document provides detailed guidance for both new chemical notifiers and jurisdictions who wish to participate in a “parallel process” which enables a company to declare to all affected countries at the time of first notification that it wants them to cooperate and share information. The hazard assessment is developed by the ‘lead’ jurisdiction and then utilized by other participating jurisdictions.
Harmonisation of Regulatory Oversight in Biotechnology Series: the new issue on the biology of Cucurbita L. species (squashes, pumpkins, zucchinis and gourds) is now available. Given the production and use of these vegetable crops worldwide, this document should be of interest for many readers.
English, PDF, 3,621kb
This communication outlines the achievements made so far by OECD in addressing the human health and environmental safety implications of manufactured nanomaterials