The document discusses APHIS' role in regulating genetically engineered organisms. APHIS derives its authority from the Plant Protection Act of 2000. Developers seeking to conduct field tests or commercialize a GE organism must submit to APHIS for review. They can undergo a notification process for organisms meeting certain criteria, or a permit process for those that don't meet criteria. APHIS inspects field tests to ensure compliance with regulations and protect plant health. Developers can petition APHIS to deregulate a GE organism if it is demonstrated to not be a plant pest.
REGULATION of biotechnological products as per spa Bindu Kshtriya
This document discusses the regulation of biotechnology products in the United States by three agencies: the FDA, USDA, and EPA. The FDA regulates food, drugs, and biologics. The USDA regulates meat, plants, and animal biologics. The EPA regulates pesticides, toxic substances, and microorganisms. Each agency has specific laws governing the areas they oversee. The regulation of genetically modified organisms depends on the product and its intended use.
Safety Data Exchange Agreements (Brief)
An integral part of enterprise risk management systems
Strategic management framework
Governance model
Standards, mechanisms, and metrics for management oversight
Roles and responsibilities
Stakeholder collaboration
Procedural documents and SDEA templates
CAPA management processes
Supporting systems
Document repositories
Dr. Jack Shere - Current Animal Disease Traceability (ADT) UpdateJohn Blue
Current Animal Disease Traceability (ADT) Update - Dr. Jack Shere, Deputy Administrator, Veterinary Services (VS), Chief Veterinary Officer, USDA, from the 2018 NIAA Annual Conference, Livestock Traceability: Opportunities for Animal Agriculture, plus the Traceability and the Real World Interactive Workshop, April 10 - 12, Denver, CO, USA.
More presentations at https://www.youtube.com/channel/UCeUDeS810OcOfuEYwj1oHKQ
Dr. Liz Wagstrom - The Future of Antibiotic Use in Pork ProductionJohn Blue
The Future of Antibiotic Use in Pork Production - Dr. Liz Wagstrom, DVM, Chief Veterinarian, National Pork Producers Council, Washington, D.C., from the 2013 Minnesota Pork Congress, January 16-17, Minneapolis, MN, USA.
More presentations at http://www.swinecast.com/2013-minnesota-pork-congress
Help Navigating the Sea of Bar-Code Medication Preparation Technologies (BCMP) Jerry Fahrni
Webinar presented on March 26, 2014 for unSUMMIT U
While a strong majority of hospitals are riding the current of bar-code medication administration (BCMA), only a few hundred have incorporated BCMP into their medication-use processes. This is about to change. The BCMP technology current is swelling, which we expect will sweep most hospitals into safer drug compounding practices within the next five years.
Based on six months of research and site visits, we will share our observations and thoughts on the two main types of BCMP workflow technologies on the market—highly automated robotic to semiautomated-manual systems. We will give attention to workflow applications, product functions and features, similarities and differences, strengths and weaknesses. We will explain various approaches to scanner-assisted ingredient verification, scales-assisted volume verification, and image-assisted order verification and archiving.
This document provides an overview of the US Food and Drug Administration (FDA) in 3 paragraphs. It discusses that the FDA was formed in 1906 and is responsible for regulating foods, drugs, medical devices, and other products. It describes the FDA's structure and responsibilities across its centers and offices. The document also provides brief summaries of the FDA approval processes for drugs, medical devices, and food products.
The document summarizes the Vaccine Adverse Event Reporting System (VAERS), which monitors safety issues with vaccines in the United States. VAERS was established in 1990 to collect reports of adverse events following vaccination. Health care providers are required to report any adverse event listed on the vaccine package insert or in the VAERS Table of Reportable Events. Anyone can submit a report to VAERS of any unwanted side effect following vaccination. While VAERS reports alone cannot prove that a vaccine caused an adverse event, the system serves as an early warning to detect potential safety issues with vaccines.
Dr. Larry Granger - Combatting Antibiotic Resistant Bacteria (CARB) - The Nee...John Blue
Combatting Antibiotic Resistant Bacteria (CARB) - The Need for Data - The USDA Perspective - Dr. Larry Granger, DVM, Senior Leader, U.S. Department of Agriculture's Animal and Plant Health Inspection Service, Veterinary Services, from the 2015 NIAA Annual Conference titled 'Water and the Future of Animal Agriculture', March 23 - March 26, 2015, Indianapolis, IN, USA.
More presentations at http://www.trufflemedia.com/agmedia/conference/2015_niaa_water_future_animal_ag
REGULATION of biotechnological products as per spa Bindu Kshtriya
This document discusses the regulation of biotechnology products in the United States by three agencies: the FDA, USDA, and EPA. The FDA regulates food, drugs, and biologics. The USDA regulates meat, plants, and animal biologics. The EPA regulates pesticides, toxic substances, and microorganisms. Each agency has specific laws governing the areas they oversee. The regulation of genetically modified organisms depends on the product and its intended use.
Safety Data Exchange Agreements (Brief)
An integral part of enterprise risk management systems
Strategic management framework
Governance model
Standards, mechanisms, and metrics for management oversight
Roles and responsibilities
Stakeholder collaboration
Procedural documents and SDEA templates
CAPA management processes
Supporting systems
Document repositories
Dr. Jack Shere - Current Animal Disease Traceability (ADT) UpdateJohn Blue
Current Animal Disease Traceability (ADT) Update - Dr. Jack Shere, Deputy Administrator, Veterinary Services (VS), Chief Veterinary Officer, USDA, from the 2018 NIAA Annual Conference, Livestock Traceability: Opportunities for Animal Agriculture, plus the Traceability and the Real World Interactive Workshop, April 10 - 12, Denver, CO, USA.
More presentations at https://www.youtube.com/channel/UCeUDeS810OcOfuEYwj1oHKQ
Dr. Liz Wagstrom - The Future of Antibiotic Use in Pork ProductionJohn Blue
The Future of Antibiotic Use in Pork Production - Dr. Liz Wagstrom, DVM, Chief Veterinarian, National Pork Producers Council, Washington, D.C., from the 2013 Minnesota Pork Congress, January 16-17, Minneapolis, MN, USA.
More presentations at http://www.swinecast.com/2013-minnesota-pork-congress
Help Navigating the Sea of Bar-Code Medication Preparation Technologies (BCMP) Jerry Fahrni
Webinar presented on March 26, 2014 for unSUMMIT U
While a strong majority of hospitals are riding the current of bar-code medication administration (BCMA), only a few hundred have incorporated BCMP into their medication-use processes. This is about to change. The BCMP technology current is swelling, which we expect will sweep most hospitals into safer drug compounding practices within the next five years.
Based on six months of research and site visits, we will share our observations and thoughts on the two main types of BCMP workflow technologies on the market—highly automated robotic to semiautomated-manual systems. We will give attention to workflow applications, product functions and features, similarities and differences, strengths and weaknesses. We will explain various approaches to scanner-assisted ingredient verification, scales-assisted volume verification, and image-assisted order verification and archiving.
This document provides an overview of the US Food and Drug Administration (FDA) in 3 paragraphs. It discusses that the FDA was formed in 1906 and is responsible for regulating foods, drugs, medical devices, and other products. It describes the FDA's structure and responsibilities across its centers and offices. The document also provides brief summaries of the FDA approval processes for drugs, medical devices, and food products.
The document summarizes the Vaccine Adverse Event Reporting System (VAERS), which monitors safety issues with vaccines in the United States. VAERS was established in 1990 to collect reports of adverse events following vaccination. Health care providers are required to report any adverse event listed on the vaccine package insert or in the VAERS Table of Reportable Events. Anyone can submit a report to VAERS of any unwanted side effect following vaccination. While VAERS reports alone cannot prove that a vaccine caused an adverse event, the system serves as an early warning to detect potential safety issues with vaccines.
Dr. Larry Granger - Combatting Antibiotic Resistant Bacteria (CARB) - The Nee...John Blue
Combatting Antibiotic Resistant Bacteria (CARB) - The Need for Data - The USDA Perspective - Dr. Larry Granger, DVM, Senior Leader, U.S. Department of Agriculture's Animal and Plant Health Inspection Service, Veterinary Services, from the 2015 NIAA Annual Conference titled 'Water and the Future of Animal Agriculture', March 23 - March 26, 2015, Indianapolis, IN, USA.
More presentations at http://www.trufflemedia.com/agmedia/conference/2015_niaa_water_future_animal_ag
FDA Globalization Act (Dingell Bill) Summary Jan 2009phillipsm4
The Food and Drug Administration Globalization Act of 2009 strengthens oversight of food, drug, medical device, and cosmetic safety. It requires facilities in the US and abroad to register annually with the FDA and pay fees to fund increased inspections. Safety plans and compliance with good manufacturing practices are also mandated. The Act aims to prevent foodborne illness and improve traceback of contaminated products. It provides the FDA with new enforcement authorities while preserving its field laboratory infrastructure.
The document analyzes legislation introduced in the California state legislature since 2000 related to genetically engineered crops and food. It finds that only 8 bills have been introduced, and only 2 passed, indicating the legislature has failed to adequately address issues around GE crops. It provides details on several key bills, including one that established a task force to study GE food impacts but did not make policy recommendations, and another that placed a moratorium on GE fish but revealed weaknesses in regulating new GE crops. In general, the document gives the legislature poor grades for its lack of protective legislation regarding GE foods and crops.
Increasing access to medicines, presentation by Edith Andrews Annan of World Health Organization (WHO) during the MeTA Ghana, CSO & media orientation workshop, 16 April 2009.
Pharmacovigilance is the science of detecting adverse effects of pharmaceutical drugs. It became important after the thalidomide incident in the 1960s which caused birth defects. The key goals of pharmacovigilance are to improve patient safety, assess benefits and risks of drugs, and promote their rational use. Individual case safety reports are a primary data source and are collected, processed, and shared using systems like VigiFlow and the global database VigiBase. India established the Pharmacovigilance Programme of India in 2010 to monitor drug safety at a national level through regional centers and collaborations with medical organizations.
This presentation provides an overview of the history of drug regulations and Good Manufacturing Practices (GMPs) in the United States. It describes how regulations have evolved over time in response to safety issues and tragedies, from the early 1900s to present day, with the goal of ensuring drug products are safe and effective. Key events and acts that shaped regulations are highlighted, including the Federal Food, Drug, and Cosmetic Act of 1938 and amendments requiring proof of efficacy and safety testing.
Mobile phone-based syndromic surveillance system for early detection and cont...ILRI
Poster by Benson Long’or, Boku Bodha, Absolomon Kihara, Haret Hambe, Viola Chemis, Adan Kutu, Osman Abdisemet, Henry Kiara, George Wamwere-Njoroge and Bernard Bett presented at the CGIAR Platform for Big Data in Agriculture Convention, Nairobi, Kenya, 3–5 October 2018.
The 1906 Pure Food and Drug Act created one of the first government regulatory agencies, now known as the FDA. It made it illegal to sell adulterated or misbranded food or drugs. This act was the culmination of 25 years of lobbying and established labeling requirements and authority for the FDA to seize illegal products. However, several human tragedies in the 1930s-1960s, including deaths from unsafe drugs, led to amendments that required manufacturers to prove a product's safety before marketing and established current Good Manufacturing Practices. Subsequent regulations aimed to prevent further tragedies and ensure stringent quality control in manufacturing.
This document provides information about the US Food and Drug Administration (FDA). It describes the organization and responsibilities of the FDA, including protecting public health by regulating food, drugs, medical devices, and other products. It also summarizes key FDA centers like the Center for Drug Evaluation and Research and Center for Biologics Evaluation and Research. The document introduces the Pharmaceutical Inspection Convention, its objectives to harmonize good manufacturing practices among countries.
Guidance for Industry Electronic Source Data in Clinical InvestigationsCRF Health
This guidance provides recommendations to sponsors, Contract Research Organizations (CROs), clinical investigators, and others involved in the capture, review, and retention of electronic source data in FDA-regulated clinical investigations.2 In an effort to streamline and modernize clinical investigations this guidance promotes capturing source data in electronic form, and it is intended to assist in ensuring the reliability, quality, integrity, and traceability of data from electronic source to electronic regulatory submission.
The document discusses regulations for clinical trials in India. It begins by explaining that an Investigational New Drug Application (IND) provides an exemption that allows investigational drugs to be transported across state lines for clinical trials. It then describes the process of submitting an IND to the FDA, including providing animal studies data, manufacturing information, clinical protocols, and investigator information. It notes that the FDA has 30 days to review submitted INDs. Finally, it summarizes that in India, an application for clinical trials should be submitted to the DCGI along with chemistry, manufacturing, animal study data and other required documents and trial protocols, and trials can only begin after approval from the DCGI and ethics committee.
The FDA is the government agency responsible for regulating food, drugs, medical devices, and other products in the United States. It has headquarters in Maryland and over 200 field offices across the country. The FDA regulates items like foods, drugs, medical devices, vaccines, and more to ensure they are safe and properly labeled. It is made up of centers that focus on specific product areas like drugs, devices, food, tobacco, and more. The document provides details on the FDA's structure, responsibilities, processes, and international collaboration efforts.
This document summarizes information from a presentation about transitioning to organic farming. It discusses what organic production means according to federal regulations, the growth in demand and market opportunities for organic products, the certification process for organic farms, and sources of assistance for farmers including organic certification cost share programs. The presentation provides contact information for organic certification programs in Virginia, North Carolina, and West Virginia as well as national resources for farmers seeking information on transitioning to organic.
This document discusses adverse drug reaction reporting and pharmacovigilance in India. It provides background on the pharmaceutical industry in India and defines adverse drug reactions and events. It describes the origins of pharmacovigilance from past drug safety issues. It outlines the various adverse drug reaction reporting centers in India and discusses the importance of pharmacovigilance for public health. It also covers communication in pharmacovigilance, roles and responsibilities, and challenges to the system in India.
Pharmacovigilance aims to detect, assess, monitor, understand, and prevent adverse drug reactions. It has evolved over time in response to drug safety issues. Key events include the Thalidomide disaster in the 1960s which led to clinical trials, and the establishment of reporting systems in the UK, US, and Europe. India launched its national pharmacovigilance program in 2010 to monitor adverse drug reactions, but progress in expanding monitoring centers has been slow. Increased funding and commitment are needed to fully establish nationwide pharmacovigilance in India.
Organic foods have experienced dramatic growth over the past two decades in the United States. Organic foods are produced without synthetic pesticides, antibiotics, or genetically modified ingredients. Several studies have found that pesticide residues are much more likely to be detected in conventional foods compared to organic foods, with residues appearing at lower frequencies and levels in organic foods. While pesticide residues in both conventional and organic foods generally fall within regulatory limits, the detection of residues at lower levels and frequencies in organic foods suggests they may pose less health risks related to pesticide exposure compared to conventional foods.
Regulatory requirements for api registrationRiyaRYadav
The document discusses regulatory requirements for registering an active pharmaceutical ingredient (API). It explains that API registration requires submitting a dossier containing information about the quality of the API. This includes details on manufacturing, characterization, controls, and stability data. The dossier is submitted to health authorities for marketing authorization. It also describes drug master files (DMFs), which provide confidential API information to regulators, and notes their use in the US and EU registration processes. DMFs can reference other DMFs. The document outlines the organization and sections of electronic common technical documents (eCTDs) used to submit API information digitally.
This document provides information about Samrudhi Livestock Private Limited, including their vision, mission, business packages, products, non-working plans, bonuses, awards, and terms and conditions. The company's vision is for everyone to become economically stable through goat farming. Members can purchase various packages starting at Rs. 999 to become a family member or top up their membership for higher non-working returns. The plans provide returns over 1-2 years through bonuses from binary teams and referrals. Higher returns are offered through awards for growing large teams, including real estate and vehicles.
FDA Globalization Act (Dingell Bill) Summary Jan 2009phillipsm4
The Food and Drug Administration Globalization Act of 2009 strengthens oversight of food, drug, medical device, and cosmetic safety. It requires facilities in the US and abroad to register annually with the FDA and pay fees to fund increased inspections. Safety plans and compliance with good manufacturing practices are also mandated. The Act aims to prevent foodborne illness and improve traceback of contaminated products. It provides the FDA with new enforcement authorities while preserving its field laboratory infrastructure.
The document analyzes legislation introduced in the California state legislature since 2000 related to genetically engineered crops and food. It finds that only 8 bills have been introduced, and only 2 passed, indicating the legislature has failed to adequately address issues around GE crops. It provides details on several key bills, including one that established a task force to study GE food impacts but did not make policy recommendations, and another that placed a moratorium on GE fish but revealed weaknesses in regulating new GE crops. In general, the document gives the legislature poor grades for its lack of protective legislation regarding GE foods and crops.
Increasing access to medicines, presentation by Edith Andrews Annan of World Health Organization (WHO) during the MeTA Ghana, CSO & media orientation workshop, 16 April 2009.
Pharmacovigilance is the science of detecting adverse effects of pharmaceutical drugs. It became important after the thalidomide incident in the 1960s which caused birth defects. The key goals of pharmacovigilance are to improve patient safety, assess benefits and risks of drugs, and promote their rational use. Individual case safety reports are a primary data source and are collected, processed, and shared using systems like VigiFlow and the global database VigiBase. India established the Pharmacovigilance Programme of India in 2010 to monitor drug safety at a national level through regional centers and collaborations with medical organizations.
This presentation provides an overview of the history of drug regulations and Good Manufacturing Practices (GMPs) in the United States. It describes how regulations have evolved over time in response to safety issues and tragedies, from the early 1900s to present day, with the goal of ensuring drug products are safe and effective. Key events and acts that shaped regulations are highlighted, including the Federal Food, Drug, and Cosmetic Act of 1938 and amendments requiring proof of efficacy and safety testing.
Mobile phone-based syndromic surveillance system for early detection and cont...ILRI
Poster by Benson Long’or, Boku Bodha, Absolomon Kihara, Haret Hambe, Viola Chemis, Adan Kutu, Osman Abdisemet, Henry Kiara, George Wamwere-Njoroge and Bernard Bett presented at the CGIAR Platform for Big Data in Agriculture Convention, Nairobi, Kenya, 3–5 October 2018.
The 1906 Pure Food and Drug Act created one of the first government regulatory agencies, now known as the FDA. It made it illegal to sell adulterated or misbranded food or drugs. This act was the culmination of 25 years of lobbying and established labeling requirements and authority for the FDA to seize illegal products. However, several human tragedies in the 1930s-1960s, including deaths from unsafe drugs, led to amendments that required manufacturers to prove a product's safety before marketing and established current Good Manufacturing Practices. Subsequent regulations aimed to prevent further tragedies and ensure stringent quality control in manufacturing.
This document provides information about the US Food and Drug Administration (FDA). It describes the organization and responsibilities of the FDA, including protecting public health by regulating food, drugs, medical devices, and other products. It also summarizes key FDA centers like the Center for Drug Evaluation and Research and Center for Biologics Evaluation and Research. The document introduces the Pharmaceutical Inspection Convention, its objectives to harmonize good manufacturing practices among countries.
Guidance for Industry Electronic Source Data in Clinical InvestigationsCRF Health
This guidance provides recommendations to sponsors, Contract Research Organizations (CROs), clinical investigators, and others involved in the capture, review, and retention of electronic source data in FDA-regulated clinical investigations.2 In an effort to streamline and modernize clinical investigations this guidance promotes capturing source data in electronic form, and it is intended to assist in ensuring the reliability, quality, integrity, and traceability of data from electronic source to electronic regulatory submission.
The document discusses regulations for clinical trials in India. It begins by explaining that an Investigational New Drug Application (IND) provides an exemption that allows investigational drugs to be transported across state lines for clinical trials. It then describes the process of submitting an IND to the FDA, including providing animal studies data, manufacturing information, clinical protocols, and investigator information. It notes that the FDA has 30 days to review submitted INDs. Finally, it summarizes that in India, an application for clinical trials should be submitted to the DCGI along with chemistry, manufacturing, animal study data and other required documents and trial protocols, and trials can only begin after approval from the DCGI and ethics committee.
The FDA is the government agency responsible for regulating food, drugs, medical devices, and other products in the United States. It has headquarters in Maryland and over 200 field offices across the country. The FDA regulates items like foods, drugs, medical devices, vaccines, and more to ensure they are safe and properly labeled. It is made up of centers that focus on specific product areas like drugs, devices, food, tobacco, and more. The document provides details on the FDA's structure, responsibilities, processes, and international collaboration efforts.
This document summarizes information from a presentation about transitioning to organic farming. It discusses what organic production means according to federal regulations, the growth in demand and market opportunities for organic products, the certification process for organic farms, and sources of assistance for farmers including organic certification cost share programs. The presentation provides contact information for organic certification programs in Virginia, North Carolina, and West Virginia as well as national resources for farmers seeking information on transitioning to organic.
This document discusses adverse drug reaction reporting and pharmacovigilance in India. It provides background on the pharmaceutical industry in India and defines adverse drug reactions and events. It describes the origins of pharmacovigilance from past drug safety issues. It outlines the various adverse drug reaction reporting centers in India and discusses the importance of pharmacovigilance for public health. It also covers communication in pharmacovigilance, roles and responsibilities, and challenges to the system in India.
Pharmacovigilance aims to detect, assess, monitor, understand, and prevent adverse drug reactions. It has evolved over time in response to drug safety issues. Key events include the Thalidomide disaster in the 1960s which led to clinical trials, and the establishment of reporting systems in the UK, US, and Europe. India launched its national pharmacovigilance program in 2010 to monitor adverse drug reactions, but progress in expanding monitoring centers has been slow. Increased funding and commitment are needed to fully establish nationwide pharmacovigilance in India.
Organic foods have experienced dramatic growth over the past two decades in the United States. Organic foods are produced without synthetic pesticides, antibiotics, or genetically modified ingredients. Several studies have found that pesticide residues are much more likely to be detected in conventional foods compared to organic foods, with residues appearing at lower frequencies and levels in organic foods. While pesticide residues in both conventional and organic foods generally fall within regulatory limits, the detection of residues at lower levels and frequencies in organic foods suggests they may pose less health risks related to pesticide exposure compared to conventional foods.
Regulatory requirements for api registrationRiyaRYadav
The document discusses regulatory requirements for registering an active pharmaceutical ingredient (API). It explains that API registration requires submitting a dossier containing information about the quality of the API. This includes details on manufacturing, characterization, controls, and stability data. The dossier is submitted to health authorities for marketing authorization. It also describes drug master files (DMFs), which provide confidential API information to regulators, and notes their use in the US and EU registration processes. DMFs can reference other DMFs. The document outlines the organization and sections of electronic common technical documents (eCTDs) used to submit API information digitally.
This document provides information about Samrudhi Livestock Private Limited, including their vision, mission, business packages, products, non-working plans, bonuses, awards, and terms and conditions. The company's vision is for everyone to become economically stable through goat farming. Members can purchase various packages starting at Rs. 999 to become a family member or top up their membership for higher non-working returns. The plans provide returns over 1-2 years through bonuses from binary teams and referrals. Higher returns are offered through awards for growing large teams, including real estate and vehicles.
Dow AgroSciences petitioned for a determination that genetically engineered corn event DAS-40278-9, which is tolerant to phenoxy auxin and ACCase inhibitor herbicides, does not pose a plant pest risk. DAS-40278-9 corn expresses the AAD-1 gene, which inactivates herbicides like 2,4-D and fop herbicides. If approved, it would provide farmers additional weed control options and help address glyphosate-resistant weeds. The FDA did not find any safety issues with DAS-40278-9 corn and the EPA is reviewing submissions regarding herbicide use on this crop.
Maria Cristina Carter is a biology teacher and research technician from McAllen, Texas with over 20 years of experience in education, corrections, and research. She has a bachelor's degree in biology and chemistry teaching certifications. Her most recent role is as a USDA plant protection aid, where she inspects for pests and diseases. Prior experience includes teaching physics, life skills, and various science subjects at multiple school districts. She also has research experience studying E. coli and training in waste water operations.
El documento describe los pasos para crear un logotipo, incluyendo dibujarlo, tomarle una foto y subirlo a un computador y posiblemente a Internet. También incluye tablas de multiplicar y varias fórmulas y funciones como convertir una edad a días, concatenar nombres, generar números aleatorios y realizar cálculos en una factura.
Hawaii's BBB aims to create an ethical marketplace where buyers and sellers can trust each other. It accomplishes this by setting standards, encouraging best practices, and denouncing substandard behavior. The BBB has over 100 offices in North America providing services to over 150 million people annually. It holds organizations accountable to high honesty standards and has earned public trust since 1912. When businesses seek BBB accreditation, they agree to follow high ethics. The BBB then provides reviews and benefits like online presence and dispute resolution to help consumers find trustworthy businesses.
This document discusses international efforts to harmonize standards for veterinary products. It describes the roles of organizations like Codex, OIE, VICH, and CVM in developing consensus standards. The goals are to ensure veterinary products are safe, effective, and of high quality globally in order to protect public health, animal health, and facilitate trade. Efforts focus on harmonizing requirements for product approval and regulation.
Here are two examples where performing a risk assessment may be beneficial:
1. When introducing a new ingredient or food product. A risk assessment could help identify any potential biological, chemical, or physical hazards and evaluate the risk to consumers from exposure to help ensure the product is safe.
2. After receiving consumer complaints of illness related to a product. A risk assessment could help determine if there is a link between the product and illnesses by identifying hazards, evaluating exposures, and characterizing potential risks to understand what controls may need to be implemented.
Performing a risk assessment provides a systematic, science-based process to identify hazards and evaluate potential risks to public health from a food. This can help inform risk management decisions to improve food safety
Georgia Registration Manuel Revised 2018.pdfJerrodLee
This document is an employee registration manual for technicians in the pest management industry in Georgia. It summarizes key federal and state laws and regulations including the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), which regulates pesticide use, labeling, and classification. It also discusses the Occupational Safety and Health Act, Endangered Species Act, and Georgia Structural Pest Control Act, the primary state law governing the pest control industry. The manual is intended to help employees prepare for the registration exam required to work in pest management in Georgia.
The Promise of Next-Generation Animal Management SystemsCognizant
Pharmaceuticals, biotech and device companies are searching for more robust next-gen animal management systems to help them enhance efficiencies, reduce costs and adhere to regulatory principles for humane animal care. This is an overview of existing systems, and the benefits, challenges, trends and technologies driving them.
The document provides an overview of the U.S. Food and Drug Administration (FDA). It discusses the history, mission, organization and functions of the FDA. Key points covered include what products and areas the FDA regulates and does not regulate, FDA advisory committees, the Code of Federal Regulations (CFR), Orange Book, Investigational New Drug applications, New Drug Applications, and other FDA processes.
AheadRace eLearning Module # 03 - Regulation and Compliance in US AgricultureSatyavardhan Reddy
* Recognize the scope of agriculture-related regulations in the U.S.
* Locate agriculture information links, law and other resources
* Explain agricultural compliance considerations
This document discusses the Orphan Drug Act and rare disease policies. It provides background on the US Orphan Drug Act of 1983, which aims to facilitate rare disease drug development by providing incentives. Key points include that the Act defines rare diseases as affecting fewer than 200,000 people, and has led to over 450 approved orphan drugs. However, the document notes that rare disease policies and the Orphan Drug Act are not the same. It advocates for India to enact its own rare disease policies and definitions to improve diagnosis, treatment and research. The Organization for Rare Diseases India is working towards this goal.
This document discusses regulatory plant pathology and the spread of plant diseases globally. It summarizes several plant diseases and insects that have spread between continents due to global trade and movement of plant materials. It then outlines the various international, regional, federal, and state organizations that regulate the movement of plants and plant pests, including the International Plant Protection Convention (IPPC) and the North American Plant Protection Organization (NAPPO). It also provides details on regulations in the US, the Plant Protection Act, and the roles of the USDA and Department of Homeland Security in inspecting imports and preventing the introduction of invasive plant pests.
This document discusses the regulatory process for biologics in the United States and Europe. It provides information on the sources and types of biologics, as well as the differences between biologics and chemical drugs. It also describes the regulatory authorities, approval processes, and requirements for a Biological License Application in the US. Finally, it compares the US and European guidelines regarding preclinical studies and requirements for approval of biologics.
Agricultural Biotechnology in 21st Century - USDA's Perspectiveapaari
The document discusses the United States Department of Agriculture's (USDA) role in regulating agricultural biotechnology, including genetically engineered (GE) plants. The USDA aims to assure the environmental safety and human/animal health safety of GE plants while promoting innovation. It oversees GE plant regulation to protect US agriculture. The USDA also clarified that it does not intend to regulate new plant breeding innovations like genome editing as long as they do not involve plant pests. Internationally, the USDA works with other countries and groups to promote consistent, science-based GE regulations and address regulatory challenges.
Dr. Annette Jones - Antimicrobial Legislation in CA: Process, Challenges, and...John Blue
Antimicrobial Legislation in CA: Process, Challenges, and Successes - Dr. Annette Jones, State Veterinarian, California Department of Food and Agriculture, from the 2016 NIAA Annual Conference: From Farm to Table - Food System Biosecurity for Animal Agriculture, April 4-7, 2016, Kansas City, MO, USA.
More presentations at http://www.trufflemedia.com/agmedia/conference/2016_niaa_farm_table_food_system_biosecurity
Legal Issues For Small-scale Poultry ProcessorsElisaMendelsohn
This document summarizes federal and state laws regarding licensing and inspection requirements for small-scale poultry processors. It begins with an overview of federal exemption rules for facilities that slaughter or process fewer than 1,000 or 20,000 birds per year. It then provides brief summaries of the laws in each state, listing any exemptions and noting the relevant regulatory agency. Alaska is summarized as having no specific small-scale poultry laws, requiring only a state permit and compliance with general food safety rules. Contact information is provided for regulators in some states.
Post-marketing surveillance involves monitoring drug safety after market release. It identifies rare or long-term adverse effects not seen in clinical trials. Manufacturers must report serious adverse events to regulatory agencies. Outsourcing bioavailability and bioequivalence studies to contract research organizations allows companies to access expertise and resources while reducing costs and time to market. CROs conduct clinical trials, data analysis, and reporting according to Good Clinical Practice standards. Qualification of appropriate CROs involves assessing capabilities, infrastructure, compliance history, and collaboration effectiveness.
Lawyer's Guide to the Veterinary Feed DirectiveCari Rincker
This presentation was created for the Lawline.com presentation titled "Lawyer's Guide to the Veterinary Feed Directive." The Lawline presentation will be on November 3, 2016 at 3:30pm ET. The recording of the lecture will subsequently be available via Lawline.com at https://www.lawline.com/faculty/cari-rincker. This presentation is broken up in two parts: (1) General Background discussing definitions, regulatory players and the legal framework, and (2) the Second VFD Rule promulgated in June 2015.
Medical Consumer Product Protection LegislationJoseph Curtis
Outlines US and International legislation initiated to minimize risk to consumers of medical products. Presents new FDA requirements for manufacturers of medical products. Covers global Clinical Trial Database systems used to evaluate product safety and post marketing studies.
How FSMA Changes The Status Quo For Food Businesseskmodza
This document summarizes how the Food Safety Modernization Act (FSMA) changes regulations for food businesses. Key points include:
1. FSMA brings the most expansive changes to food safety law since 1938 with new enforcement powers for the FDA, import requirements, and program activities.
2. Some provisions like increased records access authority, mandatory recall authority, and more frequent inspections are already in effect.
3. Soon, additional changes will take effect regarding preventative controls, traceability, foreign supplier verification, and import certification.
4. Food businesses need to update practices like supplier and recall plans, recordkeeping strategies, and insurance to minimize risks under FSMA.
Ongoing FDA Activities Related to Agricultural Biotechnology Products in the ...OECD Environment
This document summarizes the US Food and Drug Administration's (FDA) regulatory approach and activities related to agricultural biotechnology products. It discusses the FDA's 1992 policy on genetically engineered plant-derived foods, which states that foods will be regulated based on their characteristics rather than the method used to develop them. The document also summarizes the FDA's guidance and requests for comment on the regulation of genome edited plants and animals. It outlines the FDA's commitment to facilitating innovation while ensuring safety and maintaining public confidence.
Chapter wise All Notes of First year Basic Civil Engineering.pptxDenish Jangid
Chapter wise All Notes of First year Basic Civil Engineering
Syllabus
Chapter-1
Introduction to objective, scope and outcome the subject
Chapter 2
Introduction: Scope and Specialization of Civil Engineering, Role of civil Engineer in Society, Impact of infrastructural development on economy of country.
Chapter 3
Surveying: Object Principles & Types of Surveying; Site Plans, Plans & Maps; Scales & Unit of different Measurements.
Linear Measurements: Instruments used. Linear Measurement by Tape, Ranging out Survey Lines and overcoming Obstructions; Measurements on sloping ground; Tape corrections, conventional symbols. Angular Measurements: Instruments used; Introduction to Compass Surveying, Bearings and Longitude & Latitude of a Line, Introduction to total station.
Levelling: Instrument used Object of levelling, Methods of levelling in brief, and Contour maps.
Chapter 4
Buildings: Selection of site for Buildings, Layout of Building Plan, Types of buildings, Plinth area, carpet area, floor space index, Introduction to building byelaws, concept of sun light & ventilation. Components of Buildings & their functions, Basic concept of R.C.C., Introduction to types of foundation
Chapter 5
Transportation: Introduction to Transportation Engineering; Traffic and Road Safety: Types and Characteristics of Various Modes of Transportation; Various Road Traffic Signs, Causes of Accidents and Road Safety Measures.
Chapter 6
Environmental Engineering: Environmental Pollution, Environmental Acts and Regulations, Functional Concepts of Ecology, Basics of Species, Biodiversity, Ecosystem, Hydrological Cycle; Chemical Cycles: Carbon, Nitrogen & Phosphorus; Energy Flow in Ecosystems.
Water Pollution: Water Quality standards, Introduction to Treatment & Disposal of Waste Water. Reuse and Saving of Water, Rain Water Harvesting. Solid Waste Management: Classification of Solid Waste, Collection, Transportation and Disposal of Solid. Recycling of Solid Waste: Energy Recovery, Sanitary Landfill, On-Site Sanitation. Air & Noise Pollution: Primary and Secondary air pollutants, Harmful effects of Air Pollution, Control of Air Pollution. . Noise Pollution Harmful Effects of noise pollution, control of noise pollution, Global warming & Climate Change, Ozone depletion, Greenhouse effect
Text Books:
1. Palancharmy, Basic Civil Engineering, McGraw Hill publishers.
2. Satheesh Gopi, Basic Civil Engineering, Pearson Publishers.
3. Ketki Rangwala Dalal, Essentials of Civil Engineering, Charotar Publishing House.
4. BCP, Surveying volume 1
Walmart Business+ and Spark Good for Nonprofits.pdfTechSoup
"Learn about all the ways Walmart supports nonprofit organizations.
You will hear from Liz Willett, the Head of Nonprofits, and hear about what Walmart is doing to help nonprofits, including Walmart Business and Spark Good. Walmart Business+ is a new offer for nonprofits that offers discounts and also streamlines nonprofits order and expense tracking, saving time and money.
The webinar may also give some examples on how nonprofits can best leverage Walmart Business+.
The event will cover the following::
Walmart Business + (https://business.walmart.com/plus) is a new shopping experience for nonprofits, schools, and local business customers that connects an exclusive online shopping experience to stores. Benefits include free delivery and shipping, a 'Spend Analytics” feature, special discounts, deals and tax-exempt shopping.
Special TechSoup offer for a free 180 days membership, and up to $150 in discounts on eligible orders.
Spark Good (walmart.com/sparkgood) is a charitable platform that enables nonprofits to receive donations directly from customers and associates.
Answers about how you can do more with Walmart!"
This document provides an overview of wound healing, its functions, stages, mechanisms, factors affecting it, and complications.
A wound is a break in the integrity of the skin or tissues, which may be associated with disruption of the structure and function.
Healing is the body’s response to injury in an attempt to restore normal structure and functions.
Healing can occur in two ways: Regeneration and Repair
There are 4 phases of wound healing: hemostasis, inflammation, proliferation, and remodeling. This document also describes the mechanism of wound healing. Factors that affect healing include infection, uncontrolled diabetes, poor nutrition, age, anemia, the presence of foreign bodies, etc.
Complications of wound healing like infection, hyperpigmentation of scar, contractures, and keloid formation.
Beyond Degrees - Empowering the Workforce in the Context of Skills-First.pptxEduSkills OECD
Iván Bornacelly, Policy Analyst at the OECD Centre for Skills, OECD, presents at the webinar 'Tackling job market gaps with a skills-first approach' on 12 June 2024
Temple of Asclepius in Thrace. Excavation resultsKrassimira Luka
The temple and the sanctuary around were dedicated to Asklepios Zmidrenus. This name has been known since 1875 when an inscription dedicated to him was discovered in Rome. The inscription is dated in 227 AD and was left by soldiers originating from the city of Philippopolis (modern Plovdiv).
Communicating effectively and consistently with students can help them feel at ease during their learning experience and provide the instructor with a communication trail to track the course's progress. This workshop will take you through constructing an engaging course container to facilitate effective communication.
Pengantar Penggunaan Flutter - Dart programming language1.pptx
Aphis & biotechnology
1. APHIS and Biotechnology
APHIS’ authority for the regulation of
biotechnology is derived from
the Plant Protection Act of 2000.
If you are interested in APHIS’ biotechnology program initiatives
and current activities, please join our stakeholder registry to
receive automatic updates and other useful information. Register
at https://web01.aphis.usda.gov/BRS/BRSWeb.nsf.
For More Information
To find out more, please visit APHIS’ biotechnology Web site at
www.aphis.usda.gov/biotechnology/brs_main.shtml. If you have
additional questions about permitting or regulatory activities,
please call BRS at (301) 851-3886.
The U.S. Department of Agriculture (USDA) prohibits discrimination in all its programs
and activities on the basis of race, color, national origin, age, disability, and where
applicable, sex, marital status, familial status, parental status, religion, sexual orientation, genetic information, political beliefs, reprisal, or because all or part of an individual’s income is derived from any public assistance program. (Not all prohibited bases
apply to all programs.) Persons with disabilities who require alternative means for
communication of program information (Braille, large print, audiotape, etc.) should
contact USDA’s TARGET Center at (202) 720-2600 (voice and TDD). To file a complaint
of discrimination, write to USDA, Director, Office of Civil Rights, 1400 Independence
Avenue, S.W., Washington, D.C. 20250-9410, or call (800) 795-3272 (voice) or (202) 7206382 (TDD). USDA is an equal opportunity provider and employer.
This publication supersedes Program Aid No. 1841, “Biotechnology Regulatory
Services: Ensuring Safety in the Development of Genetically Engineered Organisms,”
which was published in October 2005.
Issued September 2012
United States Department of Agriculture
Animal and Plant Health Inspection Service
Program Aid No. 2120
APHIS and
Biotechnology
Protecting Plant Health Through
Rigorous Regulation of Genetically
Engineered Organisms
2. We Protect Plant Health
T
hrough our science-based regulatory
framework, the Animal and Plant Health
Inspection Service (APHIS) protects against risks to
U.S. plant health by providing for the safe importation, interstate movement, and environmental
release/field testing of certain genetically engineered
APHIS’ BIOTECHNOLOGY MISSION
(GE) organisms. APHIS is part of the U.S.
Department of Agriculture (USDA) and has
To protect and enhance America’s agricultural
regulated GE organisms since 1987.
and natural resources using a dynamic,
science-based regulatory framework to ensure
the safe importation, interstate movement,
and environmental release of genetically
engineered organisms.
APHIS regularly inspects GE field tests to monitor compliance with confinement
conditions. Here, an APHIS employee inspects GE cotton.
2
APHIS personnel inspecting GE corn at a field test site.
3
3. We’re Part of the Coordinated Framework
Established as a formal policy in 1986, the Coordinated
Framework for the Regulation of Biotechnology
describes the Federal system for evaluating products
developed using modern biotechnology. The three main
Federal agencies responsible for regulating the safe use of
genetically engineered organisms are APHIS, the U.S.
Environmental Protection Agency (EPA), and the U.S.
Department of Health and Human Services’ Food and
Drug Administration (FDA).
FDA has primary responsibility for ensuring the safety
of human food and animal feed, as well as proper
labeling and safety of all plant-derived foods and feeds.
EPA regulates pesticides, including plants with plantincorporated protectants (pesticides intended to be
produced and used in a living plant), to ensure public
safety. That agency also regulates pesticide residue on
food and animal feed. APHIS, through its Biotechnology
Regulatory Services (BRS) program, regulates the introduction of certain GE organisms that may pose a risk to
plant health.
We’re Science-Based
APHIS uses science as the foundation for sound decisions on policy, rulemaking, and regulatory approvals.
Experts in scientific fields (e.g., plant pathology, botany,
entomology, virology, ecology, environmental science,
molecular biology, and biochemistry) assess plant pest
risk and analyze environmental effects while considering
the most current peer-reviewed scientific findings. APHIS
bases its decisions and actions on the best science available.
4
Current peer-reviewed scientific data is analyzed as part of the regulatory review process.
5
4. We’re Transparent
APHIS makes it a priority to be transparent in all of our
procedures, decisions, and activities. On our Web site,
we publish relevant environmental and regulatory documents for the GE crops we regulate. We announce regulatory actions and the availability of related documents
in the Federal Register. The public may provide comments regarding proposed actions online at
www.regulations.gov, through conventional mail, and at
various public meetings. The APHIS biotechnology Web
site (www.aphis.usda.gov/biotechnology/brs_main.shtml)
offers access to a wide range of information, including
official documents, guidance for GE developers, application status, news, and upcoming events.
The APHIS Biotechnology Regulatory System
Developers seeking to field test, move interstate, or
import a GE organism must first submit detailed information to APHIS for review and receive regulatory
Six eligibility criteria for notification:
1. The GE plant is not listed as a Federal noxious
weed and is not considered a weed in the area of
introduction.
2. The genetic material must be “stably integrated”
into the plant genome.
3. The newly introduced gene’s function must be
known and not result in plant disease.
4. The newly introduced gene’s function must not
cause production of a plant pest, cause the plant to
produce substances that are toxic to nontarget
organisms, or be genetically engineered for the
purpose of producing compounds intended for
pharmaceutical or industrial use.
5. The newly introduced gene must not cause the
creation of a new plant virus.
6. The plant must not have been modified to contain
genes from animal or human pathogens.
approval. During its review, APHIS assesses the information for potential plant health risks before the introduction can be approved. Depending on the characteristics of the GE organism, a developer either files a
notification letter or applies for a permit.
The Notification Process
GE plants that meet six specific criteria (see sidebar above)
undergo an administratively streamlined alternative to
the permit process, known as “notification.”
As part of the notification process, applicants must provide information on the nature of the plant and introduced genes, descriptions of genetic modifications, size
of the introduction, and origin and destination for
movement or the location of a field test. Upon approval,
notifications are valid for 1 year from the date of issue.
If a plant does not meet the eligibility criteria for notification, the applicant must follow the permitting process.
APHIS personnel working in the ePermits system, used to electronically process permits
and notifications of regulated GE crops.
6
7
5. The Permit Process
The permit process applies to GE plants that do not
meet all six criteria for notification and to GE organisms
other than plants (e.g., insects, microbes) that fall under
APHIS regulation. This process involves a more comprehensive review than notification does. In addition to the
data required in the notification process, field-test permit
applicants must provide a detailed description of how
they will perform the test. This description must include
specific measures to reduce the risk of harm to other
plants, so the organisms being tested remain confined
and do not persist after completion of the field test.
Depending on the characteristics of the GE organism,
APHIS may impose additional measures and supplemental permit conditions. Permits may be valid for 1 year or
more from the date of issue.
APHIS also works closely with State departments of
agriculture and federally recognized tribes to ensure
that they are aware of field tests taking place within
their jurisdictions and have an opportunity to apply
any further safeguards at the State or tribal level.
Compliance With Regulations
APHIS officials perform inspections tailored to the specific requirements of the notification or permit. In addition, APHIS provides continuous education and outreach
to the regulated community, including the Biotechnology
Quality Management System (BQMS) Program. This
program provides participants with specific tools and
guidance to implement a BQMS tailored to their own
needs, facilitating more effective compliance with
APHIS regulations.
APHIS compliance specialists and inspectors perform
targeted inspections and audits to thoroughly evaluate
suspected or reported compliance infractions. The Plant
Protection Act of 2000 allows substantial penalties for
serious infractions, including fines of up to $500,000
and the possibility of criminal prosecution. APHIS works
closely with State departments of agriculture and other
Federal agencies, including the FDA and the EPA, to
ensure compliance with regulations.
8
APHIS requires that organizations conducting GE field trials keep detailed records
on all GE seed. Here, the seeds are counted, weighed, and logged.
9
6. Petition for Determining Nonregulated Status
Under the Plant Protection Act and title 7, section 340.6
of the Code of Federal Regulations (CFR), if developers
(applicants) can demonstrate that a GE organism is not a
plant pest, they can submit a petition (request) to APHIS
for a determination of nonregulated status; this status
means that the GE organism is no longer subject to regulatory oversight under 7 CFR part 340. The petitioner
must provide data, often gathered through confined field
tests regulated by APHIS, to help inform the agency’s
decision. APHIS analyzes data from the petitioner,
researches current scientific findings, and prepares a plant
pest risk assessment (PPRA) in accordance with the Act.
APHIS also prepares documentation required by the
National Environmental Policy Act of 1969 (NEPA);
under NEPA, all Federal agencies must take a close look
at the potential environmental impacts of their proposed
actions prior to making decisions. Therefore, at the same
time as it develops a PPRA, APHIS prepares either an
environmental assessment (EA) or an environmental
impact statement (EIS) to analyze potential environmental impacts the GE plant may have. Once complete,
APHIS makes the document available to the public
for comment. Overall, the petition process allows
for two, and in some cases three, opportunities for
public comment.
After receiving and considering all comments, APHIS
determines nonregulated status if it concludes that the
GE organism does not pose a plant pest risk. The GE
organism is then no longer subject to the regulations and
may be freely moved and planted without permits or
other regulatory oversight by APHIS. Most developers
will seek to obtain nonregulated status for their organism, along with completing applicable reviews at other
agencies, as a practical step toward commercialization.
10
APHIS personnel inspecting a combine harvester used in a GE corn field test.
11