The document discusses two draft Codex Alimentarius guidelines regarding the labeling of foods derived from biotechnology. Option 1 would only require labeling if the biotech food is not equivalent to its conventional counterpart, while Option 2 would mandate labeling for any food containing genetically modified organisms. The integration of these two options could require labeling for all biotech foods and significantly impact international trade. The adoption of these guidelines by Codex could allow countries to impose labeling requirements and potentially create technical barriers to trade in disputes before the WTO.
This document provides an overview of safety evaluation and standards for food packaging materials in China. It discusses the inspection and evaluation requirements for food packaging materials, including required chemistry and toxicology information. It also outlines the major regulations on packaging materials in China's Food Safety Law. Finally, it describes China's food packaging material safety standard system, including horizontal standards, additive lists, material standards, and test methods.
This document provides guidelines for the production, processing, labelling and marketing of organically produced foods. It was developed by the Codex Alimentarius Commission to facilitate international trade in organic foods and prevent misleading claims by harmonizing requirements. The guidelines cover the concept of organic production, definitions, labelling rules, production and preparation standards, substances permitted in organic production, inspection and certification systems, and import requirements. The aim is to protect consumers from fraud and help producers by ensuring organic integrity throughout the supply chain.
This document discusses risk assessment of food packaging and contact materials. It provides an overview of topics including the reasons for packaging, packaging migration factors, common packaging materials and types, regulatory approaches for food contact substances in various regions including the US, EU, Japan and others. It also outlines the types of data typically required by regulators for approval of new food contact substances, including chemistry information, migration testing conditions and protocols, and toxicology data recommendations based on expected exposure levels.
The document summarizes food regulatory frameworks and commodity food standards in China. It provides an overview of the evolution of food legislation in China from the 1950s to present. It then describes the government organizations responsible for food safety and standards. The rest of the document analyzes specific Chinese food standards for various commodity categories like frozen foods, carbonated beverages, and instant noodles through case studies. It compares Chinese standards to Codex Alimentarius formats and requirements.
this presentation mainly based on the regulatory aspects of packaging and gives all significance about packaging regulations,help in pharma or biotechnology .
The document provides an update on Japan's efforts to regulate food packaging. It discusses the country's food safety legislation framework, which is based on the Food Safety Basic Law and Food Sanitation Law. The laws aim to protect public health through regulating foods, food additives, and food-contact materials like utensils and packaging. The document outlines Japan's standards and specifications for food-contact articles, as well as voluntary industry standards for plastic materials through certification systems overseen by hygienic associations. Safety testing and restrictions on harmful substances are central to the country's regulation of plastic food packaging.
Regulatory requirements for api registrationSiddu K M
This document discusses regulatory requirements for API registration with the US FDA. It explains that a Drug Master File (DMF), also called an Active Substance Master File (ASMF), is submitted by API manufacturers to the FDA with confidential details about the API. There are different types of DMFs. Type II DMFs cover drug substances, intermediates, and materials used in their preparation. Recently, the FDA has begun assessing Type II API DMFs submitted under GDUFA. DMFs can now be submitted electronically using eCTD format. A DMF includes administrative information and quality modules providing details about the API's manufacture, characterization, controls, and stability. Filing fees for a new API DMF
This presentation gives an overview of the Drug Master File, a document submitted by the company or pharmaceutical industry to the regulatory authorities. It indicates that the company's product meets the desired quality standards. A brief introduction followed by types of DMF, its reviewing procedure and applications may give you a better understanding about Drug Master File.
This document provides an overview of safety evaluation and standards for food packaging materials in China. It discusses the inspection and evaluation requirements for food packaging materials, including required chemistry and toxicology information. It also outlines the major regulations on packaging materials in China's Food Safety Law. Finally, it describes China's food packaging material safety standard system, including horizontal standards, additive lists, material standards, and test methods.
This document provides guidelines for the production, processing, labelling and marketing of organically produced foods. It was developed by the Codex Alimentarius Commission to facilitate international trade in organic foods and prevent misleading claims by harmonizing requirements. The guidelines cover the concept of organic production, definitions, labelling rules, production and preparation standards, substances permitted in organic production, inspection and certification systems, and import requirements. The aim is to protect consumers from fraud and help producers by ensuring organic integrity throughout the supply chain.
This document discusses risk assessment of food packaging and contact materials. It provides an overview of topics including the reasons for packaging, packaging migration factors, common packaging materials and types, regulatory approaches for food contact substances in various regions including the US, EU, Japan and others. It also outlines the types of data typically required by regulators for approval of new food contact substances, including chemistry information, migration testing conditions and protocols, and toxicology data recommendations based on expected exposure levels.
The document summarizes food regulatory frameworks and commodity food standards in China. It provides an overview of the evolution of food legislation in China from the 1950s to present. It then describes the government organizations responsible for food safety and standards. The rest of the document analyzes specific Chinese food standards for various commodity categories like frozen foods, carbonated beverages, and instant noodles through case studies. It compares Chinese standards to Codex Alimentarius formats and requirements.
this presentation mainly based on the regulatory aspects of packaging and gives all significance about packaging regulations,help in pharma or biotechnology .
The document provides an update on Japan's efforts to regulate food packaging. It discusses the country's food safety legislation framework, which is based on the Food Safety Basic Law and Food Sanitation Law. The laws aim to protect public health through regulating foods, food additives, and food-contact materials like utensils and packaging. The document outlines Japan's standards and specifications for food-contact articles, as well as voluntary industry standards for plastic materials through certification systems overseen by hygienic associations. Safety testing and restrictions on harmful substances are central to the country's regulation of plastic food packaging.
Regulatory requirements for api registrationSiddu K M
This document discusses regulatory requirements for API registration with the US FDA. It explains that a Drug Master File (DMF), also called an Active Substance Master File (ASMF), is submitted by API manufacturers to the FDA with confidential details about the API. There are different types of DMFs. Type II DMFs cover drug substances, intermediates, and materials used in their preparation. Recently, the FDA has begun assessing Type II API DMFs submitted under GDUFA. DMFs can now be submitted electronically using eCTD format. A DMF includes administrative information and quality modules providing details about the API's manufacture, characterization, controls, and stability. Filing fees for a new API DMF
This presentation gives an overview of the Drug Master File, a document submitted by the company or pharmaceutical industry to the regulatory authorities. It indicates that the company's product meets the desired quality standards. A brief introduction followed by types of DMF, its reviewing procedure and applications may give you a better understanding about Drug Master File.
EU and US Procedures for API Registration - Commonalities and DifferencesMerck Life Sciences
View the interactive recording here: https://bit.ly/2PB0VZo
Abstract:
This webinar will review the current requirements for the active substance registration in the European Union and the USA. First, we will summarize the authority regulations for APIs in the EU and USA and show the similarities and differences of procedures such as CEP, AMSF, and US-DMF. Secondly, we’ll cover new trends and requirements for API-dossiers such as the control of elemental impurities according to the new international guideline ICH Q3D and related watchouts for CEPs. At the end of the presentation, we’ll discuss the eCTD roadmap for the future and the end of paper submissions.
This document discusses the benefits of third party food safety audits and outlines some issues that have arisen due to failures in the auditing process. It summarizes two major food safety crises in the US linked to failures of third party audits, highlighting the need for more rigorous auditing standards and processes. The document advocates for harmonized global food safety standards, process-based auditing, ensuring auditor competency, and the role of certification bodies in continuously improving food safety.
This document discusses Drug Master Files (DMFs) and distribution records. It provides information on the different types of DMFs, including Type I (plant information), Type II (drug substance and product information), Type III (packaging), Type IV (excipients), and Type V (other information). It notes that DMFs are confidential submissions to the FDA that can provide detailed manufacturing information to support applications like INDs or NDAs. The document also outlines what information should be included in distribution records, such as the product name, strength, customer information, quantity shipped, and control number.
Anda submission and paragraph IV certificationRichaTrivedi16
Anda submission and paragraph IV certification covers topic goals of anda , innovator/generic difference ,hatch waxman act , ANDA certification clauses , Anda review pathway , comparison of diffirent pathway
This document discusses distribution records and the Hatch-Waxman Act. It defines distribution records as written data related to the distribution of drug products from manufacturers to distributors. It notes distribution records should include information like product name, strength, recipient details, and quantities. The document also summarizes the key aspects of the Hatch-Waxman Act, including that it established the Abbreviated New Drug Application process for generics and aimed to balance interests of brand and generic drug companies as well as consumers.
This document provides information about Drug Master Files (DMFs), which are documents submitted to regulatory authorities containing information about active pharmaceutical ingredients, drug products, and other materials. It discusses the DMF processes in the United States and Europe. In the US, there are five types of DMFs that differ based on the content. The European DMF, also called the European Drug Master File or Active Substance Master File, contains confidential and public portions. DMFs allow proprietary information to remain confidential while supporting regulatory applications and maintaining quality and safety.
This seminar presentation summarizes the key points of the SPS Agreement, including:
1) The SPS Agreement is an international treaty of the WTO that was negotiated during the Uruguay Round and entered into force in 1995.
2) There are three standards organizations that set standards for SPS measures: Codex, OIE, and IPPC.
3) SPS measures can influence international trade both positively by promoting economic development and alleviating poverty, and negatively by restricting trade.
4) The SPS Agreement aims to establish rules to guide the development and enforcement of sanitary and phytosanitary measures to protect health while minimizing negative trade impacts and expanding liberalization.
This document provides information about drug master files (DMFs), including their definition, regulatory requirements, types, specifications, content, and submission process. A DMF is a confidential document containing details about the manufacturing and controls of an active pharmaceutical ingredient. There are five types of DMFs which provide information about drug substances, packaging materials, excipients, and other reference information. A Type II DMF for a drug substance must be organized according to ICH guidelines and contain manufacturing details, characterization, specifications, and stability data. Amendments and annual reports are used to update the information in a DMF.
THE SMARTER COLD CHAIN - four essentials every company should adopt (LR)Simon Daggett
This document discusses the growing importance of temperature-controlled supply chains for life sciences and healthcare companies. It notes two major trends: 1) a shift towards more complex biologic drugs that require strict temperature control and 2) escalating global regulatory requirements for compliance. The document advocates for a "smarter cold chain" approach using specialized logistics providers with expertise in temperature control and compliance. It outlines four essential components for next-generation cold chains to address these challenges: specialized knowledge, standard operating procedures, regulatory expertise, and dedicated IT systems.
Grading and sorting processes are used to classify fresh produce according to quality standards. Grading involves classifying produce into groups based on set criteria for quality and size, while sorting separates produce based on any criteria. This provides benefits like ensuring quality for consumers, establishing fair pricing for farmers, and eliminating sorting for processors. Successful grading requires produce that meets higher grades, acceptable standards, trained inspectors, and improved postharvest systems. It is also important to meet additional private standards from retailers related to food safety.
The document summarizes the key aspects of a Master Formula Record (MFR), including:
- The MFR is prepared by the R&D team and contains all information about the manufacturing process for a pharmaceutical product, including starting materials, packaging details, production steps, and quality checks.
- It serves as the reference standard for individual batch manufacturing records.
- The MFR includes detailed information like product name, active ingredients, batch size, equipment used, production steps, packaging process, theoretical and actual yields, and storage conditions.
- Preparing the MFR involves production and R&D teams and follows a standardized format and approval process.
This document discusses regulatory affairs documentation including Master Formula Records (MFRs) and Drug Master Files (DMFs). It explains that MFRs provide complete product descriptions to ensure batch-to-batch uniformity, while DMFs confidentially provide manufacturing and quality control information to regulatory agencies. Key elements of these documents are outlined, such as their structure, components, procedures for preparation and maintenance, and importance in obtaining marketing authorization and maintaining compliance.
The document discusses key aspects of current good manufacturing practices (cGMP) for pharmaceuticals. It defines cGMP and explains that the "C" stands for "current," meaning manufacturers must use up-to-date technologies and systems. cGMP covers all aspects of production from facilities, equipment, personnel, packaging, quality control, and documentation. Following cGMP is important because it helps ensure the quality, safety and effectiveness of drugs. Historical incidents like the thalidomide tragedy and Tylenol tampering case demonstrate how non-compliance with GMP can put patients' lives at risk.
Master formula record, DMF (Drug Master File), Distribution records. Generic drugs product development Introduction , Hatch-Waxman act and Amendments, CFR (CODE OF FEDERAL REGULATION) ,Drug product performance, In-vitro, ANDA regulatory approval process, NDA approval process, BE and drug product assessment, in –vivo, Scale up process approval changes, Post marketing surveillance, Outsourcing BA and BE to CRO
A Drug Master File (DMF) is a submission to the FDA that provides confidential detailed information about facilities, processes, or materials used in manufacturing drugs. There are 5 types of DMFs that cover manufacturing sites, drug substances and products, packaging materials, excipients, and other reference information. A DMF holder must authorize other applicants to reference their DMF and notify them of any changes. The DMF includes manufacturing and quality control procedures, validation data, and stability testing results.
This document outlines the Codex General Standard for Food Additives (GSFA). It establishes principles for the safe use of food additives, including that they must be approved by the Joint FAO/WHO Expert Committee on Food Additives (JECFA) and have an Acceptable Daily Intake (ADI) or other safety determination. It defines key terms and establishes a food category system to organize permitted uses of additives. The GSFA includes provisions listing specific food additives and their maximum use levels in different food categories, based on their technological need and safety as determined by JECFA and Codex.
This document discusses fish quality assurance and management. It outlines several key factors that affect fish quality, including pre-harvest and post-harvest handling, processing methods, and storage conditions. It also describes various approaches to control and manage quality, such as Hazard Analysis Critical Control Point (HACCP) plans, good hygienic practices, quality assurance programs, and ISO food safety standards. Maintaining high quality and safety of seafood requires an integrated approach across the supply chain.
This document provides information about the 4th Annual Biomarkers conference taking place on December 1-2, 2011 in London. The conference will cover biomarkers from discovery through clinical trials and safety. Key speakers will discuss regulatory perspectives, novel biomarker targets, how biomarkers can accelerate clinical development, and more. Attendees will learn about improvements in biomarker technologies and analyses of biomarkers' role in drug development. Poster presentations are encouraged. The global biomarkers market was estimated at $13.5 billion in 2010 and is predicted to reach $33.3 billion by 2015, driving growth in the industry.
1) The document discusses the role of sanitary and phytosanitary measures in international trade agreements. It outlines some of the challenges faced by the EU and US in bilateral trade negotiations, including differences in rules around issues like animal welfare, food safety standards, and pesticide use.
2) The EU wishes to address more issues in bilateral trade agreements than are currently covered in existing veterinary agreements with countries like the US. The EU wants to push principles around animal welfare, antibiotics use, and geographical indications of food products.
3) Negotiating bilateral trade agreements presents both opportunities to advance important EU policies and principles internationally, but also threats if the EU has to compromise on key positions to achieve more balanced
El documento proporciona instrucciones para crear una aplicación Android simple que realiza una división. Incluye pasos como agregar textViews y campos de texto para los números de entrada y resultado, un botón para la división, y escribir código en MainActivity.java para calcular e imprimir el resultado cuando se presiona el botón.
This document contains a summary of an individual's experience working on various SAP XI/PI integration projects over 5 years. The individual has extensive experience designing, developing, implementing, and supporting SAP XI/PI integration scenarios. Responsibilities included creating integration objects, mapping configurations, adapter configurations, testing, monitoring, and providing technical support. Relevant technical skills include SAP XI/PI, XML, SQL, and various programming languages and platforms. Professional experience summaries are provided for several consulting roles supporting large multinational clients.
EU and US Procedures for API Registration - Commonalities and DifferencesMerck Life Sciences
View the interactive recording here: https://bit.ly/2PB0VZo
Abstract:
This webinar will review the current requirements for the active substance registration in the European Union and the USA. First, we will summarize the authority regulations for APIs in the EU and USA and show the similarities and differences of procedures such as CEP, AMSF, and US-DMF. Secondly, we’ll cover new trends and requirements for API-dossiers such as the control of elemental impurities according to the new international guideline ICH Q3D and related watchouts for CEPs. At the end of the presentation, we’ll discuss the eCTD roadmap for the future and the end of paper submissions.
This document discusses the benefits of third party food safety audits and outlines some issues that have arisen due to failures in the auditing process. It summarizes two major food safety crises in the US linked to failures of third party audits, highlighting the need for more rigorous auditing standards and processes. The document advocates for harmonized global food safety standards, process-based auditing, ensuring auditor competency, and the role of certification bodies in continuously improving food safety.
This document discusses Drug Master Files (DMFs) and distribution records. It provides information on the different types of DMFs, including Type I (plant information), Type II (drug substance and product information), Type III (packaging), Type IV (excipients), and Type V (other information). It notes that DMFs are confidential submissions to the FDA that can provide detailed manufacturing information to support applications like INDs or NDAs. The document also outlines what information should be included in distribution records, such as the product name, strength, customer information, quantity shipped, and control number.
Anda submission and paragraph IV certificationRichaTrivedi16
Anda submission and paragraph IV certification covers topic goals of anda , innovator/generic difference ,hatch waxman act , ANDA certification clauses , Anda review pathway , comparison of diffirent pathway
This document discusses distribution records and the Hatch-Waxman Act. It defines distribution records as written data related to the distribution of drug products from manufacturers to distributors. It notes distribution records should include information like product name, strength, recipient details, and quantities. The document also summarizes the key aspects of the Hatch-Waxman Act, including that it established the Abbreviated New Drug Application process for generics and aimed to balance interests of brand and generic drug companies as well as consumers.
This document provides information about Drug Master Files (DMFs), which are documents submitted to regulatory authorities containing information about active pharmaceutical ingredients, drug products, and other materials. It discusses the DMF processes in the United States and Europe. In the US, there are five types of DMFs that differ based on the content. The European DMF, also called the European Drug Master File or Active Substance Master File, contains confidential and public portions. DMFs allow proprietary information to remain confidential while supporting regulatory applications and maintaining quality and safety.
This seminar presentation summarizes the key points of the SPS Agreement, including:
1) The SPS Agreement is an international treaty of the WTO that was negotiated during the Uruguay Round and entered into force in 1995.
2) There are three standards organizations that set standards for SPS measures: Codex, OIE, and IPPC.
3) SPS measures can influence international trade both positively by promoting economic development and alleviating poverty, and negatively by restricting trade.
4) The SPS Agreement aims to establish rules to guide the development and enforcement of sanitary and phytosanitary measures to protect health while minimizing negative trade impacts and expanding liberalization.
This document provides information about drug master files (DMFs), including their definition, regulatory requirements, types, specifications, content, and submission process. A DMF is a confidential document containing details about the manufacturing and controls of an active pharmaceutical ingredient. There are five types of DMFs which provide information about drug substances, packaging materials, excipients, and other reference information. A Type II DMF for a drug substance must be organized according to ICH guidelines and contain manufacturing details, characterization, specifications, and stability data. Amendments and annual reports are used to update the information in a DMF.
THE SMARTER COLD CHAIN - four essentials every company should adopt (LR)Simon Daggett
This document discusses the growing importance of temperature-controlled supply chains for life sciences and healthcare companies. It notes two major trends: 1) a shift towards more complex biologic drugs that require strict temperature control and 2) escalating global regulatory requirements for compliance. The document advocates for a "smarter cold chain" approach using specialized logistics providers with expertise in temperature control and compliance. It outlines four essential components for next-generation cold chains to address these challenges: specialized knowledge, standard operating procedures, regulatory expertise, and dedicated IT systems.
Grading and sorting processes are used to classify fresh produce according to quality standards. Grading involves classifying produce into groups based on set criteria for quality and size, while sorting separates produce based on any criteria. This provides benefits like ensuring quality for consumers, establishing fair pricing for farmers, and eliminating sorting for processors. Successful grading requires produce that meets higher grades, acceptable standards, trained inspectors, and improved postharvest systems. It is also important to meet additional private standards from retailers related to food safety.
The document summarizes the key aspects of a Master Formula Record (MFR), including:
- The MFR is prepared by the R&D team and contains all information about the manufacturing process for a pharmaceutical product, including starting materials, packaging details, production steps, and quality checks.
- It serves as the reference standard for individual batch manufacturing records.
- The MFR includes detailed information like product name, active ingredients, batch size, equipment used, production steps, packaging process, theoretical and actual yields, and storage conditions.
- Preparing the MFR involves production and R&D teams and follows a standardized format and approval process.
This document discusses regulatory affairs documentation including Master Formula Records (MFRs) and Drug Master Files (DMFs). It explains that MFRs provide complete product descriptions to ensure batch-to-batch uniformity, while DMFs confidentially provide manufacturing and quality control information to regulatory agencies. Key elements of these documents are outlined, such as their structure, components, procedures for preparation and maintenance, and importance in obtaining marketing authorization and maintaining compliance.
The document discusses key aspects of current good manufacturing practices (cGMP) for pharmaceuticals. It defines cGMP and explains that the "C" stands for "current," meaning manufacturers must use up-to-date technologies and systems. cGMP covers all aspects of production from facilities, equipment, personnel, packaging, quality control, and documentation. Following cGMP is important because it helps ensure the quality, safety and effectiveness of drugs. Historical incidents like the thalidomide tragedy and Tylenol tampering case demonstrate how non-compliance with GMP can put patients' lives at risk.
Master formula record, DMF (Drug Master File), Distribution records. Generic drugs product development Introduction , Hatch-Waxman act and Amendments, CFR (CODE OF FEDERAL REGULATION) ,Drug product performance, In-vitro, ANDA regulatory approval process, NDA approval process, BE and drug product assessment, in –vivo, Scale up process approval changes, Post marketing surveillance, Outsourcing BA and BE to CRO
A Drug Master File (DMF) is a submission to the FDA that provides confidential detailed information about facilities, processes, or materials used in manufacturing drugs. There are 5 types of DMFs that cover manufacturing sites, drug substances and products, packaging materials, excipients, and other reference information. A DMF holder must authorize other applicants to reference their DMF and notify them of any changes. The DMF includes manufacturing and quality control procedures, validation data, and stability testing results.
This document outlines the Codex General Standard for Food Additives (GSFA). It establishes principles for the safe use of food additives, including that they must be approved by the Joint FAO/WHO Expert Committee on Food Additives (JECFA) and have an Acceptable Daily Intake (ADI) or other safety determination. It defines key terms and establishes a food category system to organize permitted uses of additives. The GSFA includes provisions listing specific food additives and their maximum use levels in different food categories, based on their technological need and safety as determined by JECFA and Codex.
This document discusses fish quality assurance and management. It outlines several key factors that affect fish quality, including pre-harvest and post-harvest handling, processing methods, and storage conditions. It also describes various approaches to control and manage quality, such as Hazard Analysis Critical Control Point (HACCP) plans, good hygienic practices, quality assurance programs, and ISO food safety standards. Maintaining high quality and safety of seafood requires an integrated approach across the supply chain.
This document provides information about the 4th Annual Biomarkers conference taking place on December 1-2, 2011 in London. The conference will cover biomarkers from discovery through clinical trials and safety. Key speakers will discuss regulatory perspectives, novel biomarker targets, how biomarkers can accelerate clinical development, and more. Attendees will learn about improvements in biomarker technologies and analyses of biomarkers' role in drug development. Poster presentations are encouraged. The global biomarkers market was estimated at $13.5 billion in 2010 and is predicted to reach $33.3 billion by 2015, driving growth in the industry.
1) The document discusses the role of sanitary and phytosanitary measures in international trade agreements. It outlines some of the challenges faced by the EU and US in bilateral trade negotiations, including differences in rules around issues like animal welfare, food safety standards, and pesticide use.
2) The EU wishes to address more issues in bilateral trade agreements than are currently covered in existing veterinary agreements with countries like the US. The EU wants to push principles around animal welfare, antibiotics use, and geographical indications of food products.
3) Negotiating bilateral trade agreements presents both opportunities to advance important EU policies and principles internationally, but also threats if the EU has to compromise on key positions to achieve more balanced
El documento proporciona instrucciones para crear una aplicación Android simple que realiza una división. Incluye pasos como agregar textViews y campos de texto para los números de entrada y resultado, un botón para la división, y escribir código en MainActivity.java para calcular e imprimir el resultado cuando se presiona el botón.
This document contains a summary of an individual's experience working on various SAP XI/PI integration projects over 5 years. The individual has extensive experience designing, developing, implementing, and supporting SAP XI/PI integration scenarios. Responsibilities included creating integration objects, mapping configurations, adapter configurations, testing, monitoring, and providing technical support. Relevant technical skills include SAP XI/PI, XML, SQL, and various programming languages and platforms. Professional experience summaries are provided for several consulting roles supporting large multinational clients.
Microsoft Word se desarrolló por primera vez en 1981, y en 1989 Word, Excel y PowerPoint se lanzaron como la suite de oficina Office 1.0. Office ha tenido varias versiones importantes a través de los años, incluyendo Office 95 que incluyó un juego secreto en Excel 95, Office 97 que introdujo Outlook, y Office 2013 que fue la primera diseñada para dispositivos táctiles.
Este documento presenta tres cursos de formación profesional a distancia ofrecidos por CEAC. El primer curso es sobre Sistemas microinformáticos y Redes y enseña sobre los componentes de una computadora, dispositivos de entrada/salida, diagnóstico y reparación de averías, software básico y configuración de redes. El segundo curso es Auxiliar de Enfermería, la segunda profesión más demandada, y enseña sobre cuidado de pacientes, condiciones sanitarias y educación para la salud. El tercer curso es Deline
This document provides details of a research study exploring first year undergraduate students' engagement in social occupations during "Freshers' week". The study aimed to explore what social occupations students engaged in, why they engaged in particular occupations, and the motivational factors. The methodology involved a convenience sample of semi-structured interviews with students from two campuses. The findings identified themes around the types of social occupations students engaged in, motivational factors and barriers to participation, expectations and reflections, and implications for practice. The discussion analyzed the findings in relation to relevant literature. The conclusion was that the study met its aims and objectives, identified key motivations and barriers, and forms a basis for further research to contribute to occupational therapy practice.
La Unión Europea ha propuesto un nuevo paquete de sanciones contra Rusia que incluye un embargo al petróleo ruso. El embargo se aplicaría gradualmente durante seis meses para el petróleo crudo y ocho meses para los productos refinados. El objetivo es aumentar la presión sobre Rusia para que ponga fin a su invasión de Ucrania.
This document discusses publishing brands providing innovative advertising tools through various print media by associating with vendors, offering out-of-home advertising tools to clients.
El documento describe los pasos para desarrollar un programa simple que realiza cálculos matemáticos básicos. Incluye agregar cuadros de texto, casillas de verificación para seleccionar operaciones de suma, resta y multiplicación, y un botón para calcular el resultado que se mostrará en un cuadro de texto de salida. El último paso es ejecutar el programa una vez completado.
This document discusses the health impacts of the built environment and lifestyle factors. It summarizes research showing that medical care accounts for only a small portion of increased life expectancy, while lifestyle factors like obesity, physical inactivity, and diet play a much larger role. It also shows trends over time demonstrating increasing rates of obesity, diabetes, and physical inactivity among Americans. The document advocates for designing communities that encourage physical activity and healthy behaviors through features like walkable streets, access to nature, and mixed-use development.
Este documento analisa a relação entre os ciclos econômicos e a indústria brasileira. Apresenta uma revisão da literatura sobre ciclos econômicos e sua análise no Brasil, discute a história e importância da indústria no país, e usa modelos econométricos para medir o impacto do ciclo industrial no produto nacional ao longo do tempo. Os resultados indicam que a indústria vem perdendo influência sobre o PIB desde a década de 1980, mas ainda pode promover crescimento através de
El documento describe los pasos para crear una aplicación en Android que incluye dos text views, dos edit texts, un spinner y un botón. El código agrega estos elementos a la interfaz y muestra un resultado final en un texto view.
This document provides an overview of Sanitary and Phytosanitary (SPS) measures and the SPS Agreement. It defines SPS measures as those taken to protect human, animal, or plant life from risks arising from additives, contaminants, toxins, or diseases in foods, beverages, or feedstuffs. The SPS Agreement recognizes standards set by Codex Alimentarius, the World Organization for Animal Health, and the International Plant Protection Convention. Key provisions of the SPS Agreement include non-discrimination, scientific justification, transparency, and harmonization. The agreement helps ensure consumers have access to safe food and increases information available to importers and consumers.
Developed Codex in 1962.
Subsidiary of Food and Agriculture Organization (FAO), United Nations
(UN)and World Health Organization (WHO).
Joint venture between FAO and WHO to formulate internationally
accepted food safety standards for protection of
human health and to ensure fair trade practices.
Codex Alimentarius is a group of international food
standards, adopted by the Codex Alimentarius
Commission and uniformly presented. The very term
Codex Alimentarius is taken from the Latin term
Codex Alimentarius, meaning Food Law or Legal
Food Code. The Codex Alimentarius standards cover
all basic food types, raw, semi-processed and processed, that are
intended for distribution to the costumers.
The regulations of the Codex refer to food hygiene and quality, including
microbiological standards, food additives, pesticides and residues from
veterinary drugs, contaminants, food labeling and marketing, methods for
sampling and hazard analysis, food import and export, certification
system, etc.
Ensures that products complying with Codex standards can be sold on the
international market without compromising health or interests of
consumers. Codex standards ensure product is safe OR not
internationally. Review of member laws based in internationally accepted
scientific and technological standards.
The document discusses the challenges facing the follow-on biologics (FOB) market in the United States. It states that entry into the FOB market will be more difficult than expected, as companies will face high costs of market entry, potential physician reluctance to switch patients to biosimilars, price competition from branded products, and challenges with patent litigation. However, the document predicts the FOB market will eventually emerge and flourish, though it may grow more slowly than the generic small molecule market and biosimilars are unlikely to capture as much market share as quickly. Success in the FOB market will depend on getting products to market first and having the right strategies to navigate these challenges.
This document discusses the increasing regulatory requirements and risks around flexible food packaging. It notes that brand owners are demanding more testing and transparency from suppliers to ensure packaging safety. Material suppliers must understand how their products will be used and potential hazards to determine if they are suitable. The document also summarizes key regulations for food packaging in the US and EU and discusses approaches for determining if a product is suitable for a given use in the absence of specific regulations, including understanding the product formulation, end use conditions, potential migration, and risk assessment.
The final rules for the FDA's Food Safety Modernization Act (FSMA) are expected later this year and next year. This document discusses several key sections of FSMA that will impact food packaging manufacturers, including inspection of records, sanitary transport, mandatory recall authority, and administrative detention. It advises food packaging manufacturers to prepare now for these new FSMA requirements by updating policies and training employees on regulatory inspections, implementing transportation sanitation programs, revising recall policies, and establishing supplier approval programs.
Country of origin labelling (COOL) aims to provide transparency around where foods originate from but its implementation is complex. COOL regulations differ between countries and can be challenging for food businesses to comply with due to globalized supply chains. While COOL does not directly relate to food safety, adhering to its rules helps ensure strong traceability systems. There is ongoing debate around the costs and benefits of COOL for both consumers and businesses.
FDA’s Draft Guidance on Biosimilar Product Development and Intellectual Prope...Patton Boggs LLP
The FDA released draft guidelines for biosimilar product development to help sponsors gain approval for biosimilar drugs under an abbreviated pathway. The guidelines recommend extensive data collection to demonstrate biosimilarity to the reference product using a totality of evidence approach. Sponsors should consider analytical factors like expression systems, properties, activities, and stability testing. Following these guidelines closely during development is important for positioning products for approval and reducing litigation risks with the reference product patent owner.
Consumer Reports - Misleading Use of Organic Claims on Personal Care Products v2zq
Consumer Reports - Misleading Use of Organic Claims on Personal Care Products - Resources for Healthy Children www.scribd.com/doc/254613619 - For more information, Please see Organic Edible Schoolyards & Gardening with Children www.scribd.com/doc/254613963 - Gardening with Volcanic Rock Dust www.scribd.com/doc/254613846 - Double Food Production from your School Garden with Organic Tech www.scribd.com/doc/254613765 - Free School Gardening Art Posters www.scribd.com/doc/254613694 - Increase Food Production with Companion Planting in your School Garden www.scribd.com/doc/254609890 - Healthy Foods Dramatically Improves Student Academic Success www.scribd.com/doc/254613619 - City Chickens for your Organic School Garden www.scribd.com/doc/254613553 - Huerto Ecológico, Tecnologías Sostenibles, Agricultura Organica www.scribd.com/doc/254613494 - Simple Square Foot Gardening for Schools - Teacher Guide www.scribd.com/doc/254613410 - Free Organic Gardening Publications www.scribd.com/doc/254609890 ~
Good manufacturing practices (GMP) are regulations for ensuring that products are consistently produced and controlled according to quality standards. GMP was first established in the 1940s and adopted by the WHO in 1969 to minimize risks like contamination in pharmaceutical production. Key aspects of GMP include establishing qualified personnel and facilities, documenting procedures, validating processes, and implementing quality control, assurance, and management systems. Adherence to GMP regulations assures the identity, strength, purity and quality of drug products.
Codex Alimentarius is an international food standards body established by the World Health Organization and Food and Agriculture Organization to protect consumer health and ensure fair practices in food trade. It has developed over 200 standards covering issues like food safety, labeling, and additives. Codex standards are voluntary but used by many countries and important for facilitating international food trade while also guiding governments and businesses on food safety best practices. Key challenges include limited resources and participation by some countries as well as keeping up with a rapidly evolving global food system.
This document discusses the biosimilar drug market and opportunities for biosimilar drug developers. It notes that as biologic drug patents expire, biosimilar drugs that are comparable in efficacy and safety to reference biologics at a lower cost represent a major market opportunity. However, biosimilar market uptake faces challenges from regulatory uncertainty, physician concerns about switching patients, and efforts by innovator companies to defend their biologic drugs. The document estimates that biosimilars may not achieve critical mass adoption until 2023-2025.
The IOSR Journal of Pharmacy (IOSRPHR) is an open access online & offline peer reviewed international journal, which publishes innovative research papers, reviews, mini-reviews, short communications and notes dealing with Pharmaceutical Sciences( Pharmaceutical Technology, Pharmaceutics, Biopharmaceutics, Pharmacokinetics, Pharmaceutical/Medicinal Chemistry, Computational Chemistry and Molecular Drug Design, Pharmacognosy & Phytochemistry, Pharmacology, Pharmaceutical Analysis, Pharmacy Practice, Clinical and Hospital Pharmacy, Cell Biology, Genomics and Proteomics, Pharmacogenomics, Bioinformatics and Biotechnology of Pharmaceutical Interest........more details on Aim & Scope).
All manuscripts are subject to rapid peer review. Those of high quality (not previously published and not under consideration for publication in another journal) will be published without delay
At Clarity Quest, the future of biotechnology is more than just a few industry buzzwords—we live and breathe this stuff—and have for more than 20 years.
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Description & functions of drug regulatory affairsCepal & Co.
This document provides an introduction to regulatory affairs and good regulatory practices. It defines regulatory affairs as the interface between the pharmaceutical industry and drug regulatory authorities, and notes that regulatory affairs is involved in all stages of medicine development and post-marketing activities. The document then discusses the roles and responsibilities of regulatory professionals in liaising with health authorities, ensuring regulatory compliance, and managing product life cycles. It also outlines principles of good regulatory practices such as legality, impartiality, consistency, and transparency.
Marketing of breast milk substitutes: national implementation of the international code, status report 2020.
Este relatório fornece informações atualizadas sobre o status da implementação do Código Internacional de Comercialização de Substitutos do Leite Materno (NBCAL no Brasil) e subsequentes resoluções relevantes da Assembléia Mundial da Saúde (“o Código”) nos países. Apresenta o status legal do Código, incluindo até que ponto suas disposições foram incorporadas nas medidas legais nacionais.
Dado o importante papel dos profissionais de saúde na proteção de mulheres grávidas, mães e seus bebês da promoção inadequada de fórmulas infantis, o relatório de 2020 destaca disposições específicas consideradas particularmente úteis para abordar e eliminar a promoção de substitutos do leite materno, mamadeiras e bicos aos profissionais de saúde e nas unidades de saúde, e fornece uma extensa análise das medidas legais adotadas para proibir a promoção para os profissionais de saúde e nas unidades de saúde.
Neste relatório, um novo algoritmo de pontuação foi usado para classificar a legislação dos países. Os métodos de pontuação permitem a classificação padronizada de países, seguindo os critérios acordados entre a OMS, UNICEF e IBFAN. As medidas legais para todos os países foram analisadas com base em uma lista de verificação padronizada e expandida com um algoritmo para facilitar uma classificação sistemática e objetiva dos países de acordo com o seu alinhamento com o Código. Desde 2018, continua havendo progresso na promoção e proteção do aleitamento materno, globalmente e nos países. Medidas mais robustas para coibir práticas de marketing prejudiciais contínuas por fabricantes e distribuidores de fórmulas infantis foram adotadas em vários países.
Thahira Shireen Mustafa
Departamento de Nutrição e Segurança Alimentar
Organização Mundial da Saúde
Muito bom!
Prof. Marcus Renato de Carvalho
www.agostodourado.com
The Food Safety Modernization Act establishes new requirements for tracing foods through the supply chain. It will require recordkeeping for high-risk foods and the ability to trace foods one step forward and one step back. This poses challenges due to the complexity of distribution systems and suppliers. Regulators want faster and more consistent tracing to help narrow the scope of foodborne illness outbreaks. The new law requires the FDA to define high-risk foods and establish tracing requirements within two years, with some exemptions for small farms. It also establishes pilots to demonstrate tracing technologies and costs. Industry should view tracing as a food safety tool and work with regulators to develop effective and cost-efficient tracing systems.
Reducing transaction costs associated with sanitary and phytosanitary requirements is important for facilitating agricultural trade. The SPS Agreement aims to reduce non-tariff barriers related to food safety standards. However, complex requirements for risk assessments and private standards add to transaction costs. Trade facilitation through streamlining procedures, infrastructure development, and coordination across agencies can help lower these costs. Actions are needed at the firm, industry association, national and regional levels to address sanitary barriers and better enable countries to trade to their full potential.
Dr Dev Kambhampati | Nanotech & Human Food Guidance FDADr Dev Kambhampati
This document provides guidance for manufacturers and users of food ingredients and food contact substances on assessing the effects of significant manufacturing process changes. It discusses factors to consider in determining if a change affects the identity, safety or regulatory status of a substance. The guidance recommends consulting FDA regarding changes, especially those involving emerging technologies like nanotechnology. It also directs readers to other FDA guidance documents that provide recommendations for submitting safety data to support new uses of food substances.
2. M. Mansour & J.B. Bennett – Codex Alimentarius, Biotechnology And Technical Barriers To Trade
biotechnology food labeling, could be viewed as technical barriers to trade. For example, two Codex
committees are currently reviewing draft language that, if ultimately adopted in its present form,
could significantly impact the United States’ (US) foreign trade interests with regard to food and food
ingredients derived from modern biotechnology. The draft documents, which are under consideration
within the Codex Committee on General Principles (CCGP) and the Codex Committee on Food
Labeling (CCFL), raise important questions regarding the appropriate application and definition of
the risk management principles used to evaluate biotechnology foods in the global market and the
implications of formalizing mandatory international labeling requirements for biotechnology foods.
A brief look at the trade implications of just one of these proposals, the draft guidelines for labeling of
foods derived from biotechnology, will demonstrate the potential for such a proposal to be used as a
technical barrier to trade and a roadblock to any potential WTO case brought on such a basis.
Labeling Options
At the CCFL meeting in May 2000, the issue of labeling for foods derived from modern
biotechnology was given over to a drafting group charged with fast-tracking the development of a
Codex guideline on biotechnology food labeling. The revised draft reportedly attempts to integrate
two proposed options for labeling included in square brackets under Section 5 of the Draft
Recommendations (Codex Alimentarius Commission [Codex], 2000); a section intended to address
mandatory labeling requirements. In brief, Option 1 of these recommendations would only require
that biotechnology food be labeled in cases where the biotechnology food is not substantially
equivalent to its conventional counterpart in composition, nutritional value, or intended use. Labeling
would also be required under Option 1 in cases where the biotechnology food contains an allergen
transferred from a product recognized by Codex as causing hypersensitivity, or where the
biotechnology food contains an ingredient derived from pork fat, beef fat, or lard that is not present in
the foods’ conventional counterpart. In large part, Option 1 is consistent with the United States Food
and Drug Administrations’ (US FDA) 1992 policy addressing the labeling of foods derived from new
plant varieties (United States Food and Drug Administration [FDA], 1992).
Option 2, however, would impose mandatory labeling for any food or food ingredient that is
composed of, or contains, a genetically modified organism (GMO), even if the biotechnology food is
substantially equivalent to its conventional counterpart in composition, nutrition, and intended use. In
addition, Option 2 would require labeling where the food or food ingredient is produced from, but
does not contain, a genetically engineered organism if the food contains protein or DNA resulting
from gene technology, or is not substantially equivalent to its conventional counterpart.
In effect, the integration of Options 1 and 2 would require that all foods or food ingredients
containing genetically modified organisms be labeled, regardless of their characteristics or
equivalence to existing foods. In addition, labeling would be extended to foods that are simply
produced from, but do not contain, genetically modified organisms. Adoption of a hybrid of these
two distinct options within Codex would result in a major policy shift away from the regulation of
food and food ingredients based upon the scientific evaluation of the foods’ characteristics and
toward the regulation of food and food ingredients based categorically upon the process used for
production. It is worth noting that a third option, proposed by Norway, India, and Consumers
International, would mandate process-based labeling; in other words, any time DNA recombination
occurs, regardless of effect, or lack thereof, the food would be accordingly labeled.
Labeling, Trade And Non-Tariff Barriers
The potential for the creation of a technical barrier to trade through the adoption of such a guideline
may best be seen by looking to the emerging labeling requirements of a particular country, such as
3. M. Mansour & J.B. Bennett – Codex Alimentarius, Biotechnology And Technical Barriers To Trade
Saudi Arabia. Under the pending (now suspended until December of this year) Saudi proposal for
biotechnology labeling, the following scenario could well arise: On January 1, 2002, Company X may
export a shipment of packaged food products bound for Saudi Arabia. Upon arrival, the Saudis may
request, on the basis of CCFL decisions regarding biotechnology labeling, that Company X provide a
certificate of GM-free status, test results supporting the status determination, or the appropriate
“contains GM” label or stickers for each affected ingredient.
If Saudi Arabia were also to rely on pending decisions with the Codex committees on General
Principles, Food Hygiene, and Food Import and Export Certification, this information would be
required in addition to a certificate or label information regarding ingredient quantities or
percentages; a certificate or label information regarding the country of origin of one or more
components of the product; a general certificate of safety for consumption; a certificate attesting to
the safety of the food packaging used; a certificate attesting to the safety or Hazard Analysis and
Critical Control Point (HACCP) status of the processing and packaging establishment; and a
certificate attesting to the microbiological analysis of the product.
Such an outcome, while admittedly farfetched in its entirety, would cause severe trade dislocation,
even if effected on a piecemeal basis. As matters stand today, manufacturers already are bedeviled
by a maze of conflicting, counter-intuitive, and often useless regulatory certification documents in the
more than 150 jurisdictions around the globe that serve to do little more for food safety than provide
at great cost, time, and expense that which the worlds’ food manufacturers already do on their own
initiative—test and self-certify the safety of their products. They are bound by an enforcement
mechanism far more effective than the disapproval of one regulatory agency or another—strict
liability in tort1
for harms resulting from misbranded, mislabeled, or unsafe food products. Rather
than add additional layers of meaningless certification, Codex and its constituent members would do
better to work with industry toward the development of reliable and seamless self-certification or
third-party certification mechanisms designed to provide real, tangible evidence of proper production
and handling of food to consumers.
Codex And The WTO
In such a context, the economic and trade implications of the adoption of a Codex guideline or
recommendation on biotechnology food labeling are numerous, given the questions of scope,
application, traceability, and documentation that are to be addressed by the drafting group. However,
the controversy surrounding many of these issues and the corresponding likelihood of trade disputes
arising based on labeling concerns is not limited to the possible creation of non-tariff barriers to trade.
The elaboration of new Codex guidelines and recommendations may also impact the application of
international food safety agreements, such as the WTO Agreement on the Application of Sanitary and
Phytosanitary (SPS) Measures.
For example, by accepting the Agreement Establishing the World Trade Organization (WTO
Agreement), WTO member governments agree to be bound by the rules in all of the multilateral trade
agreements attached to it, including the SPS Agreement and the Agreement on Technical Barriers to
Trade (TBT). Codex texts are particularly relevant to the application of the SPS and TBT agreements
because the agreements specifically direct member governments to utilize texts in taking decisions
under the agreements.
Should disputes arise between member governments regarding the application of agreements, such as
the SPS or TBT, parties have recourse to the procedures for dispute settlement under the 1994
Dispute Settlement Understanding (DSU) (General Agreement on Tariffs and Trade [GATT], 1994).
Article 3 of the DSU outlines the function of the dispute settlement system, which is to preserve the
4. M. Mansour & J.B. Bennett – Codex Alimentarius, Biotechnology And Technical Barriers To Trade
rights and obligations of Members under the covered agreements and to clarify the existing provisions
of those agreements in accordance with customary rules of interpretation of public international law.
Thus, the source of law under consideration in dispute settlement is the texts of the agreements
themselves, including any explicit references to Codex guidelines, standards, or recommendations.
While the WTO itself is not responsible for developing food safety standards, it does have the
authority to place restrictions on the use of food safety measures as unjustified or disguised barriers to
trade. The WTO accomplishes this task primarily through the SPS Agreement, although the TBT
Agreement also addresses food quality requirements and other food safety issues not covered by the
SPS Agreement. As noted earlier, the trade implications of the development of Codex guidelines or
recommendations on biotechnology labeling depend in part on the referenced role of Codex
guidelines in the relevant international food safety agreements.
The role of Codex standards, guidelines, and recommendations in the application of SPS measures is
referred to several times throughout the Agreement. Perhaps most importantly, in Article 3, which
addresses the harmonization of phytosanitary standards, the SPS reads as follows,
(1) To harmonize sanitary and phytosanitary measures on as wide a basis as possible,
Members shall base their sanitary or phytosanitary measures on international
standards, guidelines, or recommendations where they exist, except as otherwise
provided for in the Agreement, and in particular, paragraph 3.[ ]
(2) Sanitary or Phytosanitary measure which conform to international standards,
guidelines, or recommendations shall be deemed necessary to protect human, animal,
or plant life or health, and presumes to be consistent with the relevant provisions of
this Agreement and of GATT 1994. International standards, guidelines, and
recommendations for food safety are further defined in Annex A to the SPS
Agreement as “the standards, guidelines, and recommendations established by the
Codex Alimentarius Commission relating to food additives, veterinary drugs and
pesticide residues, contaminants, methods of analysis and sampling, and codes and
guidelines of hygienic practice.” (World Trade Organization, 1994).
Thus, if Codex were to adopt the hybrid draft biotechnology labeling guidelines, all Member nations
would be given license to adopt the same or similar standards as national law and implement those
standards, without risk of violating either the SPS or TBT Agreements. As a result, any dispute over
market access resulting from rejection of biotechnology labeled product or prohibition from entry into
a given country must be decided in favor of the government that mandates labeling, as the WTO will
almost certainly rule in accordance with Codex labeling guidelines or recommendations in any
potential dispute settlement proceeding.
Concluding Comments
The implications for producers, consumers, and member nations of misconceived Codex guidelines or
standards relating to the labeling of biotechnologically enhanced foods would be negative and far-
reaching, not only for the agricultural biotechnology industry, but for future innovations that might be
the subject of precautionary, non-science based international food standards.
All of the foregoing is worth keeping in mind as we approach the next round of Codex sessions on
General Principles and Food Labeling, where the shape of future standards in a number of critical
areas may well be decided, for better or for worse. Regulatory fig leaves may provide convenient
short-term political relief; they are neutral at best and profoundly dangerous in the worst case, as
guarantors of a safe food supply, easily accessible, and readily affordable to the worlds’ consumers.
5. M. Mansour & J.B. Bennett – Codex Alimentarius, Biotechnology And Technical Barriers To Trade
Endnotes
1
Tort liability for food divides into two theories—one of “negligence” and one of “strict liability.”
Defendants will typically argue for the judge to apply negligence liability, because it allows them to
refer to the industry standard of care, which may be deemed enough “care” to warrant denial of the
claim. Strict liability generally divides into “defect liability” (the product’s design or manufacture
created a hazard), and “failure to warn” of a known risk, where a product is designed properly and
made properly, but still poses risks that require a warning to certain users. Failure to warn of such
risk by a food manufacturer could result in liability for harm. Food allergens fall into the “failure to
warn” group under current food safety law.
In the case of “strict liability” it is hard to generalize about its use in relation to the manufacture of
food products. Some legal cases have used a negligence standard in some situations. In such cases,
it is harder for plaintiffs to recover damages. For example, if victims of bovine spongiform
encephalopathy (BSE) brought a case against food manufacturers they might have to prove that the
BSE prion was known to be present in hamburgers at the time that they were manufactured and
sold, and that a failure to warn was the cause of the ingestion of BSE prions. Plaintiffs always
prefer to use strict liability for ease of recovery (of damages)—foods containing foreign objects or
contaminated with chemicals are easy strict liability cases. An exception is the failure to warn of
pesticide risks, which US federal law preempts in many cases under the United States
Environmental Protection Agency’s Federal Insecticide, Fungicide, and Rodenticide Act (or
FIFRA).
Perversely, regulatory “precaution” toward GMOs could increase liability for food companies if the
rDNA process is found to have set the highest standard of care for the design of foods (Redick,
2000). Negligence liability arises from a company’s failure to meet the basic standard of due care
for avoiding harm to others. Strict liability is applied to cases where there is a design defect or a
failure to warn of risks, without regard for the seller’s knowledge of lack of care in selling the
product. For example, transgenic corn can reduce the formation of mycotoxins in some areas of the
world, under some environmental conditions; if negligence applies, meeting the industry standard
of care for reducing mycotoxins might suffice as a defense. Since mycotoxins arguably are natural,
not added by humans, they might be treated under negligence in some jurisdictions. Other states in
the US might find these carcinogens to be grounds for strict liability, and the failure to test and
warn, regardless of industry practice, could lead to liability.
The advent of rDNA breeding could also lead to “design defect” product liability (ibid.), which
presents its own unique problems for defendants (food companies). For example, if genetic
engineering (rDNA) methods are developed which allow the precise deletion of genes for allergic
proteins, then a food company failing to “design” its food in such a way would expose it to design
defect strict liability. A similar “design” argument might be made by a creative plaintiffs’ attorney
who considers a mycotoxin prone food to be poorly designed, arguing by analogy that a car that
used rust-prone steel is poorly designed, or grain riddled with preventable rat feces is poorly stored.
References
Codex Alimentarius Commission (Codex). (2000). Agenda Plan 5, (CX/FL 00/6, 2000). Rome, Italy:
World Health Organization.
6. M. Mansour & J.B. Bennett – Codex Alimentarius, Biotechnology And Technical Barriers To Trade
General Agreement on Tariffs and Trade (GATT). (1994). Final Act: Agreement establishing the
World Trade Organization (Annex 2: Understanding on rules and procedures governing the
settlement of disputes). Geneva, Switzerland: Available on the World Wide Web:
http://www.wto.org/english/docs_e/legal_e/final_e.htm.
Redick, T.P. (2000). Agricultural biotechnology: Will Regulatory “precaution” expand liability
risks? (Washington Legal Foundation [WLF] Monograph). Washington, DC: WLF.
United States Food and Drug Administration (US FDA). (1992). Statement of policy: Foods derived
from new plant varieties. Washington, DC: US FDA.
World Trade Organization (WTO). (1994). The WTO agreement on the application of sanitary and
phytosanitary measures (SPS Agreement). Geneva, Switzerland: WTO. Available on the
World Wide Web: http://www.wto.org/english/docs_e/legal_e/15-sps.pdf