Perspectives on the new USDA regulations for GM Crops | GES Colloquium, Part 1 - USDA Oversight Past to Present
Video at https://go.ncsu.edu/ges-mediasite
Chat resources at https://go.ncsu.edu/ges-usda-panel-chat-links
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.
Dr. Patrick Webb - Emerging Disease Response PlanningJohn Blue
Emerging Disease Response Planning - Dr. Patrick Webb, National Pork Board, from the 2015 Iowa Pork Congress, January 28-29, Des Moines, IA, USA.
More presentations at http://www.swinecast.com/2015-iowa-pork-congress
Within the next 5-7 years, ferrofluids will be safely used to treat and cure diseases like cancer through contributions from NASA, Ferrotec, the FDA, and CDRH, which will allow minimal side effects from cancer treatment and potentially turn cancer into a non-deadly disease within 20 years, though risks like patient allergies and misdirecting the fluid need mitigation through allergy tests and operator training.
Leading Molecules to Market - An overview on licensingBananaIP Counsels
Leading Molecules to Market - An overview on licensing
Contact Us for Intellectual Property Services
BananaIP Counsels
Regd Office
No.40,3rd Main Road,JC Industrial Estate,
Kanakapura Road,Bangalore – 560 062.
Email: contact@bananaip.com
Telephone: +91-80-26860414 /24/34
The document summarizes recent advances at Inovio Pharmaceuticals, including being selected as a top translational researcher, generating immune responses in head and neck cancer patients, and protecting animals from Zika infection. It then discusses Inovio's plans to initiate a phase III trial for its HPV immunotherapy in 1H17 after an FDA request for additional information, and its partnership with MedImmune to develop immuno-oncology combination therapies. The document provides an overview of Inovio's immunotherapy technology platform and its potential applications in infectious diseases and cancer.
Regulatory aspects associated to genome editing in IndiaOECD Environment
This document summarizes India's existing biosafety regulatory framework for genetically modified organisms (GMOs) and gene technologies. It provides an overview of the key agencies and committees that regulate GMOs in India according to the Rules for Manufacture, Use, Import, Export and Storage of Hazardous Microorganisms/GMOs. It also outlines the process for approving GM crops in India and notes that new gene technologies will be regulated under the existing framework while appropriate guidelines are developed. Currently, GM cotton, brinjal, and mustard have been commercialized or are awaiting approval in India.
This document summarizes a research project that aims to develop accurate and rapid diagnostic tools for detecting exotic bacterial plant pathogens through genome-informed design. The project is developing PCR and LAMP-based diagnostics for key pathogens like Erwinia amylovora and Xanthomonas citri. Field-deployable tools like LAMP and RPA are also being validated for "smart surveillance" directly in the field. The diagnostics and training provided by this research will benefit biosecurity agencies, diagnostic laboratories, and the horticultural industry by facilitating early detection and a rapid response to incursions.
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.
Dr. Patrick Webb - Emerging Disease Response PlanningJohn Blue
Emerging Disease Response Planning - Dr. Patrick Webb, National Pork Board, from the 2015 Iowa Pork Congress, January 28-29, Des Moines, IA, USA.
More presentations at http://www.swinecast.com/2015-iowa-pork-congress
Within the next 5-7 years, ferrofluids will be safely used to treat and cure diseases like cancer through contributions from NASA, Ferrotec, the FDA, and CDRH, which will allow minimal side effects from cancer treatment and potentially turn cancer into a non-deadly disease within 20 years, though risks like patient allergies and misdirecting the fluid need mitigation through allergy tests and operator training.
Leading Molecules to Market - An overview on licensingBananaIP Counsels
Leading Molecules to Market - An overview on licensing
Contact Us for Intellectual Property Services
BananaIP Counsels
Regd Office
No.40,3rd Main Road,JC Industrial Estate,
Kanakapura Road,Bangalore – 560 062.
Email: contact@bananaip.com
Telephone: +91-80-26860414 /24/34
The document summarizes recent advances at Inovio Pharmaceuticals, including being selected as a top translational researcher, generating immune responses in head and neck cancer patients, and protecting animals from Zika infection. It then discusses Inovio's plans to initiate a phase III trial for its HPV immunotherapy in 1H17 after an FDA request for additional information, and its partnership with MedImmune to develop immuno-oncology combination therapies. The document provides an overview of Inovio's immunotherapy technology platform and its potential applications in infectious diseases and cancer.
Regulatory aspects associated to genome editing in IndiaOECD Environment
This document summarizes India's existing biosafety regulatory framework for genetically modified organisms (GMOs) and gene technologies. It provides an overview of the key agencies and committees that regulate GMOs in India according to the Rules for Manufacture, Use, Import, Export and Storage of Hazardous Microorganisms/GMOs. It also outlines the process for approving GM crops in India and notes that new gene technologies will be regulated under the existing framework while appropriate guidelines are developed. Currently, GM cotton, brinjal, and mustard have been commercialized or are awaiting approval in India.
This document summarizes a research project that aims to develop accurate and rapid diagnostic tools for detecting exotic bacterial plant pathogens through genome-informed design. The project is developing PCR and LAMP-based diagnostics for key pathogens like Erwinia amylovora and Xanthomonas citri. Field-deployable tools like LAMP and RPA are also being validated for "smart surveillance" directly in the field. The diagnostics and training provided by this research will benefit biosecurity agencies, diagnostic laboratories, and the horticultural industry by facilitating early detection and a rapid response to incursions.
Current risk assessment approaches for environmental and food & feed safety -...OECD Environment
This presentation highlights the history of risk and safety assessment approaches for GEOs/GMOs, the current application of risk and safety assessment approaches for GEOs/GMOs and the Implications for emerging applications of genome editing and their assessment.
OECD Co-operative research programme - Gary FittOECD Environment
This presentation provides an overview of OECD activities related to the Co-operative Research Programme (CRP). The CRP aims to strengthen scientific knowledge and provide relevant scientific information to feed into future policy decisions related to the sustainable use of natural resources, in the areas of food, agriculture, forests and fisheries.
This document summarizes a research project studying the molecular response of tephritid fruit flies to sublethal stresses. The project aims to:
1) Identify the molecular pathways activated in fruit flies exposed to heat, cold, radiation, and parasitic infection stresses.
2) Construct a regulatory network of stress response genes in two key fruit fly pests.
3) Validate specific genes' roles in stress response through functional assays.
The goal is to develop more effective and environmentally friendly postharvest treatments for controlling fruit flies, providing benefits to the horticulture industry, government pest management strategies, and researchers.
This document summarizes research aimed at improving biosecurity decision making for plant pathogens through surveillance modeling. The researchers are developing models and protocols to optimize quarantine zone setting, eradication strategies, and incursion responses. Models of Panama Tropical Race 4 spread and Queensland fruit fly population genetics inform decision processes. The research will deliver publications, conferences, software, and training to benefit state governments, surveillance providers, and horticultural industries through smarter pest detection and control.
Genetic molecular markers to accelerate genetic gains in cropsICRISAT
Accelerating and delivering genetic gains in smallholder farmers’ fields is high on international agricultural research agenda, especially in Asia and sub-Saharan Africa. This will help in improving crop productivity, better yield and higher income for farmers and most importantly achieving food and nutrition security in developing countries. Conventional plant breeding approaches have contributed immensely to this; however, they have limitations in terms of delivering improved varieties with desired traits in a time-bound manner. Genomics tools and technologies have changed methods of plant breeding in a positive direction.
Dr. Patrick McDermott - One Health Antibiotic Stewardship State of Science - ...John Blue
This document summarizes the 20-year history and strategic plans of the National Antimicrobial Resistance Monitoring System (NARMS). NARMS monitors antimicrobial resistance in foodborne bacteria to inform human and veterinary medicine. The strategic plan includes improving sampling representativeness, data analysis and reporting, collaborative research, and international partnerships. Advances in whole genome sequencing and metagenomics now allow comprehensive resistance gene detection and correlations between genotypes and phenotypes. Moving forward, NARMS aims to expand surveillance within a One Health framework.
This research project is collecting data on past pest invasions in both Australia and New Zealand, in order to identify common patterns in plant biosecurity pests.
This document discusses the development of a protocol for detecting the grape pest phylloxera using quantitative PCR (qPCR) in soil samples. The objectives are to create a sampling and detection method that is accurate, sensitive, cost-effective and can be applied to other pests. It aims to obtain endorsement to incorporate the qPCR method into the national phylloxera management standard. The research aims to benefit the wine industry through improved surveillance and early detection of phylloxera, as well as regulators and researchers.
Advanced Report Customization via VSClinicalGolden Helix
This document provides a summary of a presentation about advanced customization capabilities for clinical reports using VSClinical software:
- VSClinical allows customization of clinical reports through custom HTML, XML, JSON templates and scripts to enhance Word reports and integrate with REST APIs.
- Templates are provided for germline and somatic variant analysis that include ACMG/AMP guidelines and can be further customized.
- Reports can include additional data such as gene impact analysis, drug/trial information, and machine-readable outputs like JSON can be generated.
- A product demo was given to showcase report customization features.
VarSeq provides powerful annotation capabilities for variant analysis including gene tracks, assemblies, variant functions, frequency tracks, functional predictions, and transcript annotations. It integrates information from over 20 public databases and sources and updates annotations monthly to provide the most current clinically relevant information for researchers. By centralizing variant annotations from disparate sources, VarSeq saves customers significant time and resources compared to manual curation of this data.
An Exploration of Clinical Workflows in VarSeqGolden Helix
In this webcast, we feature several example workflows and helpful features in the VarSeq that can be used in the clinic. We discuss options for conducting a comprehensive gene panel analysis for cancer or hereditary diseases. Then we introduce an example of a single exome workflow that goes from an unfiltered VCF created by a secondary analysis pipeline to a report containing information about interesting variants. Finally, we walk through an example of a trio analysis showcasing a variety of different filter options as well as inheritance patterns. All these workflows will result in a customizable clinical report.
Exome Analysis with VS-CNV and VSClinical: Updated Strategies and Expanded Ca...Golden Helix
This document summarizes a presentation given by Gabe Rudy, VP of Product & Engineering at Golden Helix, on updated strategies and expanded capabilities for exome analysis with VS-CNV and VSClinical. The presentation demonstrates new features for enhanced variant analysis, including analyzing splice site, non-coding RNA, and mitochondrial variants. It also reviews improvements to Golden Helix's exome CNV calling in VarSeq, including a new low-quality target filter strategy that reduces the number of CNVs called while maintaining sensitivity and precision. Additional capabilities discussed include generating synchronized clinical reports and incorporating virtual gene panels.
Introducing VSClinical AMP Guidelines: A Comprehensive Workflow for NGS Testi...Golden Helix
Golden Helix is introducing new guidelines for next-generation sequencing (NGS) testing of cancer samples using their VSClinical software. The AMP guidelines provide a comprehensive workflow for variant filtering, annotation, classification evidence levels, and integrated clinical reporting of somatic and germline variants. The software utilizes various data sources to aid in cancer interpretation and allows users to save and reuse interpretations. An upcoming webinar will demonstrate how to score somatic variants for oncogenicity using VSClinical.
This course provides a basic description of an FDA regulatory strategy for medical devices and explains the relationships between regulatory strategy and product development. It offers guidelines for developing successful strategies for medical devices,
Vaxin Notice of Allowance Release.finalBill Enright
Vaxin Inc., a clinical stage vaccine and immunotherapeutics company, has been granted Notices of Allowance from the USPTO for two new patents protecting elements of its hepatitis B and influenza vaccine candidates. The patents cover an aqueous formulation for Vaxin's HepTcell hepatitis B immunotherapy product and the intranasal administration of its NasoVax influenza vaccine to induce immune responses. With these additions, Vaxin now has 37 patents in 13 countries protecting its products. The company is on track to begin three phase 1 clinical trials within the next 9 months.
AMP-Based Variant Classification with VSClinicalGolden Helix
The document discusses Golden Helix's VSClinical software and its capabilities for analyzing biomarkers and variants according to AMP and ACMG guidelines. VSClinical provides a four-phased workflow to 1) filter variants, 2) assess evidence, 3) develop classifications, and 4) include interpretations in clinical reports. It leverages Golden Helix's CancerKB knowledgebase to accelerate variant interpretation and standardized reporting. The document demonstrates VSClinical's analysis and reporting of variants from a myeloid gene panel according to AMP guidelines.
Non-Resistant Antimicrobial Therapy: Treating Superbugs That Cause Nosocomial...kphodel
This document discusses a new treatment for hospital-acquired pneumonia (HAP) using a combination of SynAmp, a non-antibiotic compound that enhances antibiotic potency, and an antibiotic. HAP is a major problem with high mortality and increasing antibiotic resistance. The combination therapy is a first-line treatment for HAP that is dosed once daily and shows no resistance after 30 days. It has intellectual property protection and competitive advantages over current treatments. With expedited regulatory pathways, the company aims to launch the primary HAP indication with $200 million in annual sales and expand to other infections. Funding is sought to further develop the pre-clinical candidate.
1) Avalanche Biotechnologies is developing gene therapy treatments for eye diseases using its Ocular BioFactoryTM platform. Its lead product AVA-101 has shown promising clinical results for wet age-related macular degeneration (AMD) with patients gaining or maintaining vision with few additional treatments needed over one year.
2) Avalanche has an integrated gene therapy discovery, development and manufacturing platform and a pipeline of other programs including a collaboration with Regeneron. It has an experienced management team in the areas of gene therapy and ophthalmology.
3) The company highlights its potential to develop one-time transformative treatments for major sight-threatening diseases in ophthalmology using its Ocular BioFactoryTM platform
This document provides an overview of genetically modified organisms (GMOs) presented at a conference for women farmers. It defines GMOs and the process of genetic engineering used to create them. The presentation discusses why GMOs are made, whether they are safe, and how they are regulated. It provides examples of commercialized GMO crops and their benefits, such as herbicide and insect resistance. Potential risks like environmental impacts and health issues are addressed, but major scientific organizations have found GMO risks to be no different than conventional crops. The process of developing and commercializing a GMO crop takes over 13 years and over $136 million.
David Glass Presentation at 2010 Algae Biomass SummitDavid Glass
Slides from a presentation given by David Glass, "Impact of Biotechnology Regulations on Use of Genetically Modified Algae in Biofuel Production", at the 2010 Algae Biomass Summit, Phoenix, AZ, September 28, 2010.
Current risk assessment approaches for environmental and food & feed safety -...OECD Environment
This presentation highlights the history of risk and safety assessment approaches for GEOs/GMOs, the current application of risk and safety assessment approaches for GEOs/GMOs and the Implications for emerging applications of genome editing and their assessment.
OECD Co-operative research programme - Gary FittOECD Environment
This presentation provides an overview of OECD activities related to the Co-operative Research Programme (CRP). The CRP aims to strengthen scientific knowledge and provide relevant scientific information to feed into future policy decisions related to the sustainable use of natural resources, in the areas of food, agriculture, forests and fisheries.
This document summarizes a research project studying the molecular response of tephritid fruit flies to sublethal stresses. The project aims to:
1) Identify the molecular pathways activated in fruit flies exposed to heat, cold, radiation, and parasitic infection stresses.
2) Construct a regulatory network of stress response genes in two key fruit fly pests.
3) Validate specific genes' roles in stress response through functional assays.
The goal is to develop more effective and environmentally friendly postharvest treatments for controlling fruit flies, providing benefits to the horticulture industry, government pest management strategies, and researchers.
This document summarizes research aimed at improving biosecurity decision making for plant pathogens through surveillance modeling. The researchers are developing models and protocols to optimize quarantine zone setting, eradication strategies, and incursion responses. Models of Panama Tropical Race 4 spread and Queensland fruit fly population genetics inform decision processes. The research will deliver publications, conferences, software, and training to benefit state governments, surveillance providers, and horticultural industries through smarter pest detection and control.
Genetic molecular markers to accelerate genetic gains in cropsICRISAT
Accelerating and delivering genetic gains in smallholder farmers’ fields is high on international agricultural research agenda, especially in Asia and sub-Saharan Africa. This will help in improving crop productivity, better yield and higher income for farmers and most importantly achieving food and nutrition security in developing countries. Conventional plant breeding approaches have contributed immensely to this; however, they have limitations in terms of delivering improved varieties with desired traits in a time-bound manner. Genomics tools and technologies have changed methods of plant breeding in a positive direction.
Dr. Patrick McDermott - One Health Antibiotic Stewardship State of Science - ...John Blue
This document summarizes the 20-year history and strategic plans of the National Antimicrobial Resistance Monitoring System (NARMS). NARMS monitors antimicrobial resistance in foodborne bacteria to inform human and veterinary medicine. The strategic plan includes improving sampling representativeness, data analysis and reporting, collaborative research, and international partnerships. Advances in whole genome sequencing and metagenomics now allow comprehensive resistance gene detection and correlations between genotypes and phenotypes. Moving forward, NARMS aims to expand surveillance within a One Health framework.
This research project is collecting data on past pest invasions in both Australia and New Zealand, in order to identify common patterns in plant biosecurity pests.
This document discusses the development of a protocol for detecting the grape pest phylloxera using quantitative PCR (qPCR) in soil samples. The objectives are to create a sampling and detection method that is accurate, sensitive, cost-effective and can be applied to other pests. It aims to obtain endorsement to incorporate the qPCR method into the national phylloxera management standard. The research aims to benefit the wine industry through improved surveillance and early detection of phylloxera, as well as regulators and researchers.
Advanced Report Customization via VSClinicalGolden Helix
This document provides a summary of a presentation about advanced customization capabilities for clinical reports using VSClinical software:
- VSClinical allows customization of clinical reports through custom HTML, XML, JSON templates and scripts to enhance Word reports and integrate with REST APIs.
- Templates are provided for germline and somatic variant analysis that include ACMG/AMP guidelines and can be further customized.
- Reports can include additional data such as gene impact analysis, drug/trial information, and machine-readable outputs like JSON can be generated.
- A product demo was given to showcase report customization features.
VarSeq provides powerful annotation capabilities for variant analysis including gene tracks, assemblies, variant functions, frequency tracks, functional predictions, and transcript annotations. It integrates information from over 20 public databases and sources and updates annotations monthly to provide the most current clinically relevant information for researchers. By centralizing variant annotations from disparate sources, VarSeq saves customers significant time and resources compared to manual curation of this data.
An Exploration of Clinical Workflows in VarSeqGolden Helix
In this webcast, we feature several example workflows and helpful features in the VarSeq that can be used in the clinic. We discuss options for conducting a comprehensive gene panel analysis for cancer or hereditary diseases. Then we introduce an example of a single exome workflow that goes from an unfiltered VCF created by a secondary analysis pipeline to a report containing information about interesting variants. Finally, we walk through an example of a trio analysis showcasing a variety of different filter options as well as inheritance patterns. All these workflows will result in a customizable clinical report.
Exome Analysis with VS-CNV and VSClinical: Updated Strategies and Expanded Ca...Golden Helix
This document summarizes a presentation given by Gabe Rudy, VP of Product & Engineering at Golden Helix, on updated strategies and expanded capabilities for exome analysis with VS-CNV and VSClinical. The presentation demonstrates new features for enhanced variant analysis, including analyzing splice site, non-coding RNA, and mitochondrial variants. It also reviews improvements to Golden Helix's exome CNV calling in VarSeq, including a new low-quality target filter strategy that reduces the number of CNVs called while maintaining sensitivity and precision. Additional capabilities discussed include generating synchronized clinical reports and incorporating virtual gene panels.
Introducing VSClinical AMP Guidelines: A Comprehensive Workflow for NGS Testi...Golden Helix
Golden Helix is introducing new guidelines for next-generation sequencing (NGS) testing of cancer samples using their VSClinical software. The AMP guidelines provide a comprehensive workflow for variant filtering, annotation, classification evidence levels, and integrated clinical reporting of somatic and germline variants. The software utilizes various data sources to aid in cancer interpretation and allows users to save and reuse interpretations. An upcoming webinar will demonstrate how to score somatic variants for oncogenicity using VSClinical.
This course provides a basic description of an FDA regulatory strategy for medical devices and explains the relationships between regulatory strategy and product development. It offers guidelines for developing successful strategies for medical devices,
Vaxin Notice of Allowance Release.finalBill Enright
Vaxin Inc., a clinical stage vaccine and immunotherapeutics company, has been granted Notices of Allowance from the USPTO for two new patents protecting elements of its hepatitis B and influenza vaccine candidates. The patents cover an aqueous formulation for Vaxin's HepTcell hepatitis B immunotherapy product and the intranasal administration of its NasoVax influenza vaccine to induce immune responses. With these additions, Vaxin now has 37 patents in 13 countries protecting its products. The company is on track to begin three phase 1 clinical trials within the next 9 months.
AMP-Based Variant Classification with VSClinicalGolden Helix
The document discusses Golden Helix's VSClinical software and its capabilities for analyzing biomarkers and variants according to AMP and ACMG guidelines. VSClinical provides a four-phased workflow to 1) filter variants, 2) assess evidence, 3) develop classifications, and 4) include interpretations in clinical reports. It leverages Golden Helix's CancerKB knowledgebase to accelerate variant interpretation and standardized reporting. The document demonstrates VSClinical's analysis and reporting of variants from a myeloid gene panel according to AMP guidelines.
Non-Resistant Antimicrobial Therapy: Treating Superbugs That Cause Nosocomial...kphodel
This document discusses a new treatment for hospital-acquired pneumonia (HAP) using a combination of SynAmp, a non-antibiotic compound that enhances antibiotic potency, and an antibiotic. HAP is a major problem with high mortality and increasing antibiotic resistance. The combination therapy is a first-line treatment for HAP that is dosed once daily and shows no resistance after 30 days. It has intellectual property protection and competitive advantages over current treatments. With expedited regulatory pathways, the company aims to launch the primary HAP indication with $200 million in annual sales and expand to other infections. Funding is sought to further develop the pre-clinical candidate.
1) Avalanche Biotechnologies is developing gene therapy treatments for eye diseases using its Ocular BioFactoryTM platform. Its lead product AVA-101 has shown promising clinical results for wet age-related macular degeneration (AMD) with patients gaining or maintaining vision with few additional treatments needed over one year.
2) Avalanche has an integrated gene therapy discovery, development and manufacturing platform and a pipeline of other programs including a collaboration with Regeneron. It has an experienced management team in the areas of gene therapy and ophthalmology.
3) The company highlights its potential to develop one-time transformative treatments for major sight-threatening diseases in ophthalmology using its Ocular BioFactoryTM platform
This document provides an overview of genetically modified organisms (GMOs) presented at a conference for women farmers. It defines GMOs and the process of genetic engineering used to create them. The presentation discusses why GMOs are made, whether they are safe, and how they are regulated. It provides examples of commercialized GMO crops and their benefits, such as herbicide and insect resistance. Potential risks like environmental impacts and health issues are addressed, but major scientific organizations have found GMO risks to be no different than conventional crops. The process of developing and commercializing a GMO crop takes over 13 years and over $136 million.
David Glass Presentation at 2010 Algae Biomass SummitDavid Glass
Slides from a presentation given by David Glass, "Impact of Biotechnology Regulations on Use of Genetically Modified Algae in Biofuel Production", at the 2010 Algae Biomass Summit, Phoenix, AZ, September 28, 2010.
My presentation to MSU's International Short Course
Biosafety and Biotechnology for Lawyers, in coordination with the AU/NEPAD African Biosafety Network of Expertise (ABNE)
Genetic Modified Organism Regulation in IndiaMeehirMerai
The document discusses India's standards for the release and use of genetically modified organisms (GMOs). It provides definitions of GMOs and explains how they are created by inserting foreign genes into organisms' DNA. It then discusses the main benefits of genetically modifying agricultural plants and animals. The document goes on to summarize India's policies and regulatory framework for ensuring biosafety of GMOs, including guidelines, committees, and containment facilities required for research. It also notes the countries that use GMO technology the most and some concerns about their use.
This document discusses regulatory frameworks for genetically modified crops at the national and international level. It provides an overview of:
- International efforts in food safety and principles of GM food safety assessment.
- How different countries/regions like the US, Canada, EU, Argentina, India, etc. have different agencies that regulate GM crop food safety and environmental release. The definitions of GMOs also vary between countries' laws.
- India's regulatory framework is established under the Environment Protection Act 1986. Key agencies involved include GEAC, RCGM and SBCC. Guidelines development involves expert consultation and consideration of research.
- The process for developing a GM crop in India involves extensive molecular, compositional and safety assessment
What makes a city a hub of entrepreneurship? Successes and reinvestment.James McCarter
When Jim McCarter founded Divergence, Inc. in 1998, St. Louis was far from a start-up hub. The Company's successful acquisition by Monsanto is now but one indicator of a burgeoning entrepreneurial tech scene in St. Louis. Here's a tour from the science behind Divergence, to Monsanto Growth Ventures, to BioGenerator and other innovation engines of the region.
Genetic modification and gene editing techniques allow scientists to alter genes in crops and livestock in order to produce desirable traits more rapidly than traditional breeding methods. While genetically modified foods may have benefits like increased nutrient levels or resistance to pests and drought, there are also concerns about potential health risks and environmental impacts. Gene editing provides a targeted way to modify genes and could help address some concerns about genetic modification, but there are still legal and social issues surrounding new food technologies.
David Glass BIO World Congress Synthetic Biology Regulation july 2015David Glass
Presentation from July 2015 BIO World Congress on Industrial Biotechnology, assessing the adequacy of government regulatory frameworks to assess the risks of commercial uses of synthetic biology.
Legal implications are the results or consequences of being involved in something according to the law. A good example is the case of marriage. As a consequence of being married, all property is considered co-owned as long as you acquired after you got married. A legal implication can either be positive or negative.
This presentation shows the importance of choosing safe food and becoming aware of modified which might be hazard to your heath, you will know exactly what GMF is.
International and National guidelines regarding use of genetically modified ...berciyalgolda1
This document provides an overview of international and national guidelines regarding the use of genetically modified organisms (GMOs) in the environment, food, and pharmaceuticals. It defines GMOs and the genetic engineering techniques used to create them. It discusses where GMOs are currently used and the safety issues considered in their risk assessments, including potential toxicity, allergenicity, and nutritional impacts. The document also outlines India's regulatory framework for GMOs, including the various committees and guidelines established under the Rules of 1989 to ensure their safe research, development, and environmental release.
transgenic crops and their regulatory systemGuru P N
This document summarizes the steps involved in developing transgenic crops and the regulatory approval system for biotech crops in India. It discusses how transgenic crops are created by introducing transgenes using techniques like Agrobacterium transformation. It also outlines the Indian regulatory system overseen by organizations like GEAC, RCGM and IBSC that aim to ensure the safety of GM crops. The system involves approvals for research, field trials and environmental release of transgenic crops. However, limitations of the current system are that it lacks adequate risk assessment standards and procedures and does not fully incorporate international biosafety protocols.
Raising Awareness and Discovering the Dirt 12345 .docxrobert345678
Raising Awareness and Discovering the Dirt
12345 Canyon Dr., Northridge, CA 91344 (818) 555-9089 (818) 555-9222 Radd.com
RADD
What role can the FDA play in regulating GMO
products?
This brief is intended for the United States Food and Drug Administration (FDA) and is
presented on behalf of Raising Awareness and Discovering the Dirt (RADD). RADD is a non-profit
organization committed to promoting the wellness of the environment.
Since the earlier 1990s, commercialization of Genetic Modified Organisms (GMOs) has spread
throughout the U.S. The FDA has promoted a program of self-regulation among the biotech crop and
food developers (www.fda.gov). Many of the biotech food and crop developers’ primary interest is the
development of high-yielding products. For example, Monsanto, a biotech food and crop developer’s
director of corporate communications, Philip Angell was quoted saying; “Monsanto should not have to
vouchsafe the safety of biotech food. Our interest is in selling as much of it as possible. Assuring its
safety is the FDA’s job,” (Antoniou, Robinson, & Fagan, 2012, p. 23).
Finally, research and Monsanto’s own feeding trials revealed health-effects and suggest that
more suitable options are needed to maintain the safety of consumers and the environment. Therefore,
RADD is committed to working with the FDA in creating programs that will ensure the safety of
environment and the use of GMOs.
Statement of Issue:
In order to promote awareness and ultimately protect the health of consumers, the FDA has the
ability to regulate GMOs by establishing new guidelines. There is a growing body of evidence that
connects GMOs with health problems, environmental damage, and violation of rights of farmers and
consumers. Studies show a correlation between GMOs and health problems such as production of new
allergens increased toxicity, decreased nutrition, and antibiotic resistance (Bernstein et al., 2003).
Additionally, since the emergence of GMO crops, there has been an increase in the amount of
agriculture changes. Such changes include the development of “massive weeds” and “super bugs,” both
requiring an increased dosage of toxins to rid of these unwanted, overgrown organisms. In return,
consumers are now ingesting these increased dosages of toxins.
Background:
Ultimately, the only beneficiaries of products containing GMOs are its producers, such as,
Monsanto, rather than consumers. Monsanto makes an abundant amount of profit on their GMO
products as they have scientifically modified crops, allowing them to have faster results. The “proposed”
purpose of GMOs was to increase yield and enhance nutritional value, while also lowering the use of
pesticides. (www.nongmoproject.org, 2013). Indeed, the use of GMOs increase yield, but studies show
that GMO products hold no nutritional value and rather, by decreasing the use of pesticides, there has
been an increase .
Gene editing is a new technology that allows precise modifications to DNA sequences. It holds promise for treating diseases, enhancing crops, and modifying human embryos, but also raises complex ethical issues that require careful consideration. This presentation will explore both the technical aspects and far-reaching implications of gene editing from medical, agricultural, and societal perspectives, addressing concerns around safety, germline editing, and ensuring equitable access to its benefits.
The Documented Health Risks of Genetically Engineered Foods (Long Version)Jack Olmsted
Content of the Presentation
Regulatory Failure: It is useful to explain how such dangerous products could have made it to the market with government approval. Several slides include quotes from formerly secret FDA documents that show how government policy was at odds with more cautious scientific opinion at the agency.
Health Risks of GMOs: This section highlights many of the adverse findings revealed through laboratory experiments and reported by farmers, doctors, and investigators. It also introduces some theoretical risks based on the current state of the science.
The Consumer Tipping Point: The final section includes a discussion of a strategy to achieve the tipping point of consumer rejection of GMOs in the US, which is the basis for our Campaign for Healthier Eating in America. The key elements needed are consumer education on GMO health risks combined with clear non-GMO choices.
The Institute for Responsible Technology http://www.responsibletechnology.org/resources/powerpoint-presentation-on-gmos
Science of Genetic Engineering as it relates to the California Initiative to ...Belinda Martineau
Slides used for an educational event related to The California Right to Know Genetically Engineered Food Act. The event was held at the Rudolf Steiner College in Fair Oaks, California on March 23, 2012.
“The FDA has placed the interest of a handful of biotechnology companies ahead of their responsibility to protect public health. By failing to require testing and labeling of genetically engineered foods, the agency has made consumers unknowing guinea pigs for potentially harmful, unregulated food substances.”
- Andrew Kimbrell, executive director of Center for Food Safety
intelectual property rights on transgenicsAnilkumar C
This document discusses transgenic crops, including their promises such as increased food production and quality as well as reduced pesticide usage. It outlines the process of making transgenic plants and provides an overview of GM crop status globally and in India. The document also discusses the handling, testing, and regulatory issues around transgenic crops, including the various competent authorities and categories of genetic engineering experiments in India. It notes the infrastructure needed to work with transgenic crops, including laboratory, greenhouse, and field facilities, and the roles of public and private sectors in agricultural biotechnology research.
Regulation and intellectual property of agricultural biotechnologies: Perspe...ExternalEvents
Regulation and intellectual property of agricultural biotechnologies: Perspectives from the private sector presentation by "Adrianne Massey, Biotechnology Industry Organization, Washington D.C., United States of America
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1 Jennifer Kuzma USDA Rule Panel, 6-5-2020
1. USDA Oversight Past to Present
JENNIFER KUZMA, PHD
CO-DIRECTOR OF GES CENTER
GOODNIGHT-NC GSK FOUNDATION DISTINGUISHED PROFESSOR
SCHOOL OF PUBLIC AND INTERNATIONAL AFFAIRS
Disclaimer:
We are academics trying to understand the new rule. Although we have decades of
experience working with GM crop regulation and genetic engineering & societal issues,
we do not claim to have all the answers about the details or impacts on different sectors.
We are presenting how we understand the process and issues for discussion purposes.
Thank you!
2. Coordinated Framework for Regulation of Biotechnology
No new categories of risks, no new laws needed, “product not process”
EPA BiopesticideFDA GM plant food/feed—FFDCA
• Voluntary
• No determination of safety
USDA Plant Pest Act
• GM plants with plant pest DNA
sequences
EPA FIFRA
• plant incorporated protectants (Bt)
All other plants have been exempted since
mid 2000s-2010
• USDA Am I Regulated Process
8. Sustainable, Ecological, Consistent, Uniform, Responsible, Efficient (SECURE) rule
“organisms modified through GE”
GE is “techniques that use recombinant, synthesized, or amplified nucleic acids to modify or createa genome”
Organism that can directly or indirectly injure, cause damage to, or cause disease in any plant or plant product
11. Pros and Cons of SECURE
PROS
Shift to Plant Pest Risk Focus and away from
DNA presence
Tiered approach—exempt things with which
we have experience
Provisioning of information and FR comment
period for some categories
E.g new USDA exemptions for what could be
achieved from conventional breeding
CONs
•Failure to invoke Noxious Weed provisions of
PPA---despite main risks of 1st gen GM crops
•Exemptions having little to do with potential
product risk
•Lack of public information for self or USDA
confirmed exempt
•Lack of formal assessment & comment period
in FR for RSR determinations
12. Estimate of $8.3M annual cost
savings to private industry
$3.4 M cost to APHIS
Not over $100M so no CBA
mandated by EO 12866
USDA Timeline of
Implementation
of SECURE