Pesticides
The scope of what diligence is due in any corporate transaction has evolved greatly over the past decade, particularly with respect to transactions involving chemical products. Once upon a time, transactional due diligence involving chemical products, whether ‘neat’ (pure) chemicals, formulations or end-use products, typically consisted of a phase I or phase II environmental site assessment (ESA) focusing on identifying contamination derivative of chemical releases into environmental media as effluent, emissions, fugitive releases or waste, as well as quantifying the potential for such releases to pose litigation risks or regulatory enforcement, or require costly remediation. Increasingly, parties to corporate transactions now continue to focus on these liabilities and on the compositional elements of chemical products themselves as potential sources of liability and commercial disruption. This article explains why the transition to chemical product due diligence has been slow and offers a few tips to help assess what diligence is due in corporate transactions involving chemical products.
Emerging tools enabled by nanotechnology, synthetic biology, and other innovative technologies are today increasingly supplementing the ploughs and tractors so emblematic of the agricultural community of the past. These precision farming tools are ensuring a sustainable food supply otherwise threatened by climate change and population growth, among other global challenges, while diminishing worldwide greenhouse gas emissions. Genetically modified E coli is being used to produce synthetically-derived pheromones, substances beneficially used in agricultural applications to attract, capture, and eliminate harmful pests. Agricultural stakeholders use nanopesticides and nanofertilisers in drought-stricken regions, minimising the need for more conventional and environmentally consequential agricultural chemicals. GPS-based auto-steering systems for tractors augment human labour, freeing up effort better spent on other tasks. These technologies enable global agricultural professionals to address the climate change imperatives which threaten an increasingly fragile global food supply.
Lawyers counselling companies in the biotechnology, biopesticide and related crop protection and industrial biotechnology areas appreciate the critically important role federal agencies play in ensuring the success of start-up businesses.
Federal agencies, including the US Environmental Protection Agency (EPA) and the US Food and Drug Administration (FDA), among others, wield enormous power over businesses that require premarket product approval. While we product approval practitioners know this, it comes as a bit of a surprise when investors, poised to make multimillion-dollar investments in start-up businesses, neglect to focus on the regulatory integrity of the start-up. This lack of focus invites costly mistakes. This article explains why, and how to avoid making these mistakes.
The International Estimated Short-Term Intake IESTI equations are used during the establishment of Codex Maximum Residue Limits. A recent proposal to revise the equations sparked international debate regarding selection of residue inputs and the appropriate level of consumer protection. The 49th Codex Committee on Pesticide Residues meeting recommended benchmarking the IESTI equations against distributions of actual exposures. Using publicly available data and models, this work compares dietary exposures for strawberries, tomatoes, and apples at five levels of refinement to place these equations into context relative to real-world exposures. Case studies were based on availability of robust USDA PDP monitoring data, which is uniquely suited to refine dietary exposures for a population. Benchmarking dietary exposure involves several decision points. Alternate methodology choices are not expected to impact the large margins observed between the probabilistic estimates and the IESTI equations or to change the overall conclusion that existing IESTI equations are conservative and health-protective.
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