Introduction and U.K.’s exit from the EU On leaving the EU, EU-REACH legislation was copied over into UK-REACH as of 01 January 2020. Applying to only England, Wales and Scotland (collectively referred to as Great Britain or GB), Northern Ireland continues to be regulated by EU-REACH. The UK-REACH transitional arrangements …
How to de-risk OECD 443 studies through optimized dose level selections
The European Chemicals Agency (ECHA) recently conducted a review project regarding the design of the OECD 443 (Extended One-Generation Reproductive Toxicity Study, or EOGRTS). The project’s goal was to assess the performance of the study in terms of study design, conduct and findings to determine if the study design currently …
Faster access to biopesticide alternatives to conventional pesticides under the U.S. BPPD regulatory framework
There is pressure worldwide for better, faster access to biological alternatives to conventional crop protection chemicals (CPCs). The U.S. Environmental Protection Agency (EPA) is ahead of regions such as the European Union (EU) in revising its regulatory approaches for biopesticides and in having a division dedicated to them, namely, the …
What the latest changes to EU regulations and data requirements mean for your microbial biopesticide registrations and renewals
Despite perceptions that biopesticides are inherently less dangerous, the EU regulates them as stringently as conventional, potentially highly hazardous, synthetic plant protection chemicals (Regulation [EC] No. 1107/2009). This has made approvals costly and slow. Recent regulatory revisions intended to redress this—to give EU farmers better and faster access to biological …
New OECD TG 497: Interpretation and application of defined approaches for skin sensitization assessment
The advent of requiring multiple non-animal in vitro alternatives for skin sensitization assessments has prompted the Organisation for Economic Co-operation and Development (OECD) to publish new guidance to outline the approaches for data interpretation from multiple non-animal test methods. When used together in specific combinations, these methods will aid with …
Advancing inhalation toxicology capabilities to support chemical testing
Respiratory exposure to chemicals or agrochemicals poses potential risk to human health, especially to workers handling these products. Whether preparing a solution, dusting or spraying crops, or cleaning equipment, opportunities for inadvertent inhalation is a risk that can potentially lead to toxic effects, both acute and chronic. That’s why identifying …
TSCA and US state legislation: Navigating your chemical or agrochemical through the federal and state regulatory landscape in the USA
Registering your chemical or crop protection product with the US EPA under TSCA or FIFRA is the first and biggest step in its regulatory journey in the USA. But you will also need to navigate state-specific legislation and regulations, and for crop chemicals this includes registering in every state where …
Uncovering the Regulatory Advice Affecting OECD 443 Study Design and the Impact on Your Ongoing and Future Studies
The Extended One Generation Reproductive Toxicity Study (EOGRTS, EU B.56, OECD TG 443) has been the information requirement for reproductive toxicity under the Registration, Evaluation, Authorization, and Restriction of Chemicals (REACH, Annexes IX and X, Section 8.7.3.) since March 2015. In July 2021, an evaluation of 12 test cases of …
Expanded crop protection and chemical testing: For those committed to our planet’s sustainability and the welfare of humanity
We’ve been ramping up our product testing support at some of our European sites over the past few years to meet the needs of the rapidly growing crop protection and chemical industry. Now, we’re excited to announce a multimillion-dollar expansion at our Greenfield, Indiana campus in the U.S. that enhances …
What is an Inhalation reprotoxicology study – insights, advice, and secrets
What is Inhalation Reprotoxicology and When is it Relevant? Inhalation reprotoxicology studies are required when a chemical substance or plant protection product (PPP) is suspected of having the potential to cause reproductive or developmental toxicity and there is the possibility that human exposure can occur via the respiratory system.