Mobile Alert and Warning in the United States and Japan: Confronting the Challenges of International Harmonization

A U.S.-Japan expert workshop on mobile alert and warning was held online 8–10 September 2021. Funded by the Japan Foundation’s Center for Global Partnership (CGP) and responding to the Sendai Framework for Disaster Risk Reduction 2015–2030, the workshop compared U.S. and Japanese mobile alert and warning contexts, systems, policies, and messages to investigate possibilities for international harmonization of mobile device-based early warning. The workshop’s sessions revealed two interrelated issues that repeatedly surfaced among workshop participants: culture and policy. The workshop illuminated several possibilities and problems confronting U.S., Japanese, and global stakeholders as they develop, deploy, and seek to improve the effectiveness of mobile alert and warning systems and messages.

The regulation of genome-edited crops

To explore the regulation of genome edited crops, this chapter describes the regulatory systems adopted by different countries as well as how the Cartagena Biosafety Protocol might apply. It finds there is a continuum of oversight, with some countries applying their GMO biosafety laws to all genome edited crops and other countries exempting certain genome edited techniques and/or products from any special oversight. For countries with what on the surface seem like similar regulatory policies, when their regulations are applied to identical products, they often produce different results, which will make international harmonization difficult. In addition, how much oversight to impose on different crops tends not to be based on scientific evidence. Finally, the regulatory treatment for multi-edited products is unclear. It will take time and additional the development of additional genome edited crops before there is sufficient clarity on how all types of genome edited crops will be regulated.

International Legal Approaches to Neurosurgery for Psychiatric Disorders

Neurosurgery for psychiatric disorders (NPD), also sometimes referred to as psychosurgery, is rapidly evolving, with new techniques and indications being investigated actively. Many within the field have suggested that some form of guidelines or regulations are needed to help ensure that a promising field develops safely. Multiple countries have enacted specific laws regulating NPD. This article reviews NPD-specific laws drawn from North and South America, Asia and Europe, in order to identify the typical form and contents of these laws and to set the groundwork for the design of an optimal regulation for the field. Key challenges for this design that are revealed by the review are how to define the scope of the law (what should be regulated), what types of regulations are required (eligibility criteria, approval procedures, data collection, and oversight mechanisms), and how to approach international harmonization given the potential migration of researchers and patients.

International Harmonization of Nomenclature and Diagnostic Criteria (INHAND): Nonproliferative and Proliferative Lesions of the Dog

The INHAND (International Harmonization of Nomenclature and Diagnostic Criteria for Lesions) Project ( www.toxpath.org/inhand.asp ) is a joint initiative of the societies of toxicologic Pathology from Europe (ESTP), Great Britain (BSTP), Japan (JSTP), and North America (STP) to develop an internationally accepted nomenclature for proliferative and nonproliferative lesions in laboratory animals. The purpose of this publication is to provide a standardized nomenclature for classifying lesions observed in most tissues and organs from the dog used in nonclinical safety studies. Some of the lesions are illustrated by color photomicrographs. The standardized nomenclature presented in this document is also available electronically on the internet ( http://www.goreni.org/ ). Sources of material included histopathology databases from government, academia, and industrial laboratories throughout the world. Content includes spontaneous lesions, lesions induced by exposure to test materials, and relevant infectious and parasitic lesions. A widely accepted and utilized international harmonization of nomenclature for lesions in laboratory animals will provide a common language among regulatory and scientific research organizations in different countries and increase and enrich international exchanges of information among toxicologists and pathologists.

International Harmonization of Nomenclature and Diagnostic Criteria (INHAND): Nonproliferative and Proliferative Lesions of the Minipig

The INHAND (International Harmonization of Nomenclature and Diagnostic Criteria for Lesions) Project ( www.toxpath.org/inhand.asp ) is a joint initiative of the Societies of Toxicologic Pathology from Europe (ESTP), Great Britain (BSTP), Japan (JSTP), and North America (STP) to develop an internationally accepted nomenclature for proliferative and nonproliferative lesions in laboratory animals. The purpose of this publication is to provide a standardized nomenclature for classifying microscopic lesions observed in most tissues and organs from the minipig used in nonclinical safety studies. Some of the lesions are illustrated by color photomicrographs. The standardized nomenclature presented in this document is also available electronically on the internet ( http://www.goreni.org/ ). Sources of material included histopathology databases from government, academia, and industrial laboratories throughout the world. Content includes spontaneous lesions as well as lesions induced by exposure to test materials. Relevant infectious and parasitic lesions are included as well. A widely accepted and utilized international harmonization of nomenclature for lesions in laboratory animals will provide a common language among regulatory and scientific research organizations in different countries and increase and enrich international exchanges of information among toxicologists and pathologists.