Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption (US Food and Drug Administration Regulation) (FDA) (2018 Edition) The Law Library presents the complete text of the Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption (US Food and Drug Administration Regulation) (FDA) (2018 Edition). Updated as of May 29, 2018 To minimize the risk of serious adverse health consequences or death from consumption of contaminated produce, the Food and Drug Administration (FDA or we) is establishing science-based minimum standards for the safe growing, harvesting, packing, and holding of produce, meaning fruits and vegetables grown for human consumption. FDA is establishing these standards as part of our implementation of the FDA Food Safety and Modernization Act. These standards do not apply to produce that is rarely consumed raw, produce for personal or on-farm consumption, or produce that is not a raw agricultural commodity. In addition, produce that receives commercial processing that adequately reduces the presence of microorganisms of public health significance is eligible for exemption from the requirements of this rule. The rule sets forth procedures, processes, and practices that minimize the risk of serious adverse health consequences or death, including those reasonably necessary to prevent the introduction of known or reasonably foreseeable biological hazards into or onto produce and to provide reasonable assurances that the produce is not adulterated on account of such hazards. We expect the rule to reduce foodborne illness associated with the consumption of contaminated produce. This book contains: - The complete text of the Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption (US Food and Drug Administration Regulation) (FDA) (2018 Edition) - A table of contents with the page number of each section

The Food Safety Handbook: A Practical Guide for Building a Robust Food Safety Management System, contains detailed information on food safety systems and what large and small food industry companies can do to establish, maintain, and enhance food safety in their operations. This new edition updates the guidelines and regulations since the previous 2016 edition, drawing on best practices and the knowledge IFC has gained in supporting food business operators around the world. The Food Safety Handbook is indispensable for all food business operators -- anywhere along the food production and processing value chain -- who want to develop a new food safety system or strengthen an existing one.

Each Trade Policy Review consists of three parts: a report by the government under review, a report written independently by the WTO Secretariat, and the concluding remarks by the chair of the Trade Policy Review Body. A highlights section provides an overview of key trade facts. 15 to 20 new review titles are published each year. The reviews consist of detailed chapters examining the trade policies and practices of the member and describing trade policy-making institutions and the macroeconomic situation; these chapters are preceded by the Secretariat's Summary Observations, which summarize the report and presents the Secretariat's perspective on the member's trade policies. The Secretariat report and the member's policy statement are published after the review meeting, along with the minutes of the meeting and the text of the Chairperson's Concluding Remarks.

The term 'medical devices' covers a wide range of equipment essential for patient care at every level of the health service, whether at the bedside, at a health clinic or in a large specialised hospital. Yet many countries lack access to high-quality devices, particularly in developing countries where health technology assessments are rare and there is a lack of regulatory controls to prevent the use of substandard devices. This publication provides a guidance framework for countries wishing to create or modify their own regulatory systems for medical devices, based on best practice experience in other countries. Issues highlighted include: the need for harmonised regulations; and the adoption, where appropriate, of device approvals of advanced regulatory systems to avoid an unnecessary drain on scarce resources. These approaches allow emphasis to be placed on locally-assessed needs, including vendor and device registration, training and surveillance and information exchange systems.

Food safety awareness is at an all time high, new and emerging threats to the food supply are being recognized, and consumers are eating more and more meals prepared outside of the home. Accordingly, retail and foodservice establishments, as well as food producers at all levels of the food production chain, have a growing responsibility to ensure that proper food safety and sanitation practices are followed, thereby, safeguarding the health of their guests and customers. Achieving food safety success in this changing environment requires going beyond traditional training, testing, and inspectional approaches to managing risks. It requires a better understanding of organizational culture and the human dimensions of food safety. To improve the food safety performance of a retail or foodservice establishment, an organization with thousands of employees, or a local community, you must change the way people do things. You must change their behavior. In fact, simply put, food safety equals behavior. When viewed from these lenses, one of the most common contributing causes of food borne disease is unsafe behavior (such as improper hand washing, cross-contamination, or undercooking food). Thus, to improve food safety, we need to better integrate food science with behavioral science and use a systems-based approach to managing food safety risk. The importance of organizational culture, human behavior, and systems thinking is well documented in the occupational safety and health fields. However, significant contributions to the scientific literature on these topics are noticeably absent in the field of food safety.

Globalization is rapidly changing lives and industries around the world. Drug development, authorization, and regulatory supervision have become international endeavors, with most medicines becoming global commodities. Drug companies utilize global supply chains that often include facilities in countries with inconsistent regulations from those of the United States, perform pivotal trials in multiple countries to support registration submissions in various jurisdictions, and subsequently market their medicines throughout most of the world. These companies operate across borders and require individual national regulators to ensure that drugs authorized for use in their countries are safe and effective, and appropriate for their health care system and their population. This process involves significant resources and often duplicative work. It is important to consider how this process can be improved in order to better allocate resources, time, and efforts to improve public health. Regulating Medicines in a Globalized World: The Need for Increased Reliance Among Regulators considers the role of mutual recognition and other reliance activities among regulators in contributing to enhancing public health. This report identifies opportunities for leveraging reliance activities more broadly in order to potentially impact public health globally. Key topics in this report include the job of medicines regulators in today's world, what policy makers need to know about today's regulatory environment, stakeholder views of recognition and reliance, as well as removing impediments and facilitating action for greater recognition and reliance among regulatory authorities.