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.
David Glass World Biofuels Markets Conference Presentation, March 2011David Glass
Presentation by David Glass at 2011 World Biofuels Markets Conference, Rotterdam, the Netherlands, March 22, 2011. This presentation describes approaches being taken to use advanced biotechnology to improve the plant species being used as biofuel feedstocks. This was part of the "Energy Crops" sessions at the conference, which Dr. Glass moderated.
David Glass Regulatory Presentation and Case Study BIO Pac Rim Conference Dec...David Glass
Presentation from BIO Pacific Rim Conference December 2013, providing an overview of regulations affecting industrial biotechnology, and presenting a case study of an MCAN successfully submitted to the EPA for a genetically modified cyanobacterium for production of ethanol.
This is a presentation I made on February 2, 2010 at the EUEC 2010 conference in Phoenix. The talk included an overview of the approaches being pursued to use biotechnology to improve microorganisms, algae and plants for biofuel production and the companies pursuing these strategies, and discussion of the impact of biotech regulations on these projects and the prospects for use of engineered organisms in commercial biofuel production. You can find more detailed information on the topics discussed in this talk on my blog at http://dglassassociates.wordpress.com.
Application and Regulation of the Use of Photosynthetic Microorganisms in Bio...David Glass
David Glass Presentation at Alternative Fuels & Chemicals Coalition Biobased Economy Conference, November 15, 2021. Discusses the potential for uses of modified algae and cyanobacteria for production of chemicals and fuels, and how such uses would be regulated in the US and elsewhere in the world.
David Glass BIO World Congress Algae Regulation July 2015David Glass
Presentation summarizing how industrial biotechnology projects involving genetically modified algae would be regulated in the U.S. and internationally, including strategies and road maps to obtain approvals for such projects.
David Glass Industrial Biotechnology Regulatory ExperienceDavid Glass
Summary of projects carried out by David Glass, D. Glass Associates, Inc., to assist U.S. and international industrial biotechnology companies prepare for and comply with government regulation of their activities.
David Glass Plenary Presentation at 4th Algal Biomass, Biofuels and Bioproduc...David Glass
The document discusses the history and current state of U.S. biotechnology regulation as it pertains to genetically modified algae. It notes that while the regulatory framework subjects genetically engineered organisms to additional scrutiny, approvals for commercial uses of GM algae are possible with proper planning and scientific evidence. It outlines the roles of the EPA, USDA and FDA in regulating GM organisms and provides details on relevant regulations. It also discusses scientific issues to address in risk assessments and the need for research to inform the regulatory process.
This document provides an overview of U.S. regulations for novel food ingredients, including food additives, GRAS substances, dietary supplements, and case studies on specific emerging technologies like genetically modified plants, cell-based and plant-based meats, and animal food ingredients. It describes the regulatory authorities of the FDA and USDA and various approval pathways including food additive petitions, GRAS notifications, and AAFCO new ingredient definitions.
David Glass World Biofuels Markets Conference Presentation, March 2011David Glass
Presentation by David Glass at 2011 World Biofuels Markets Conference, Rotterdam, the Netherlands, March 22, 2011. This presentation describes approaches being taken to use advanced biotechnology to improve the plant species being used as biofuel feedstocks. This was part of the "Energy Crops" sessions at the conference, which Dr. Glass moderated.
David Glass Regulatory Presentation and Case Study BIO Pac Rim Conference Dec...David Glass
Presentation from BIO Pacific Rim Conference December 2013, providing an overview of regulations affecting industrial biotechnology, and presenting a case study of an MCAN successfully submitted to the EPA for a genetically modified cyanobacterium for production of ethanol.
This is a presentation I made on February 2, 2010 at the EUEC 2010 conference in Phoenix. The talk included an overview of the approaches being pursued to use biotechnology to improve microorganisms, algae and plants for biofuel production and the companies pursuing these strategies, and discussion of the impact of biotech regulations on these projects and the prospects for use of engineered organisms in commercial biofuel production. You can find more detailed information on the topics discussed in this talk on my blog at http://dglassassociates.wordpress.com.
Application and Regulation of the Use of Photosynthetic Microorganisms in Bio...David Glass
David Glass Presentation at Alternative Fuels & Chemicals Coalition Biobased Economy Conference, November 15, 2021. Discusses the potential for uses of modified algae and cyanobacteria for production of chemicals and fuels, and how such uses would be regulated in the US and elsewhere in the world.
David Glass BIO World Congress Algae Regulation July 2015David Glass
Presentation summarizing how industrial biotechnology projects involving genetically modified algae would be regulated in the U.S. and internationally, including strategies and road maps to obtain approvals for such projects.
David Glass Industrial Biotechnology Regulatory ExperienceDavid Glass
Summary of projects carried out by David Glass, D. Glass Associates, Inc., to assist U.S. and international industrial biotechnology companies prepare for and comply with government regulation of their activities.
David Glass Plenary Presentation at 4th Algal Biomass, Biofuels and Bioproduc...David Glass
The document discusses the history and current state of U.S. biotechnology regulation as it pertains to genetically modified algae. It notes that while the regulatory framework subjects genetically engineered organisms to additional scrutiny, approvals for commercial uses of GM algae are possible with proper planning and scientific evidence. It outlines the roles of the EPA, USDA and FDA in regulating GM organisms and provides details on relevant regulations. It also discusses scientific issues to address in risk assessments and the need for research to inform the regulatory process.
This document provides an overview of U.S. regulations for novel food ingredients, including food additives, GRAS substances, dietary supplements, and case studies on specific emerging technologies like genetically modified plants, cell-based and plant-based meats, and animal food ingredients. It describes the regulatory authorities of the FDA and USDA and various approval pathways including food additive petitions, GRAS notifications, and AAFCO new ingredient definitions.
Presentation at 2016 Fuel Ethanol Workshop, describing U.S. regulatory pathways for approval of use of modified microorganisms in animal feed, and a proposal for making such pathways simpler and more efficient for modified strains of common microorganisms.
David Glass Presentation at 2016 BIO World CongressDavid Glass
Presentation describing the status of the ongoing efforts to update and modernize the Federal Government's Coordinated Framework for Biotechnology Regulation.
Challenges and Opportunities in Industrial Biotech RegulationDavid Glass
Presentation at Society for Biological Engineering Workshop, "Technology Challenges and Opportunities in Commercializing Industrial Biotechnology", San Diego September 29, 2015.
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.
Next-generation waxy corn – a flagship case of SDN-1/NHEJ genome editing via ...OECD Environment
1) DowDuPont is developing waxy corn varieties using CRISPR/Cas9 genome editing to introduce a targeted mutation in the waxy gene that results in the entire coding sequence being deleted.
2) Trials show the CRISPR-edited waxy corn has identical phenotypes and starch properties as conventional waxy corn varieties.
3) CRISPR-edited waxy corn hybrids have shown improved yields compared to conventional hybrid checks in agronomic trials.
This document discusses the applications of nanotechnology in the food industry. It begins with an introduction and discusses the need for nanotechnology in the food sector. It then covers various applications of nanotechnology including nanoencapsulation, nanoemulsions, nanoparticles for active packaging, nanoclays for packaging, and nanosensors for packaging and processing plants. Specific examples of products that utilize these nanotechnology applications are also provided. The document concludes by noting regulatory considerations for nanotechnology in food.
Presented by Doris Wangari, Program for Biosafety Systems (PBS), Kenya, at the Workshop on Animal Genetic Research for Africa (Biosciences for Farming in Africa), Nairobi, 10-11 September 2015
04 control of spills and mechanism of implementation of biosafety guidelinesIndranil Bhattacharjee
1. The document outlines procedures for controlling spills of biological materials in laboratories, including spills in biological safety cabinets, open laboratories, centrifuges, and on persons. It describes wearing protective equipment, warning others, and using appropriate disinfectants.
2. It then describes the mechanism for implementing biosafety guidelines in India, including committees that provide oversight of recombinant DNA research. The key committees are the Recombinant DNA Advisory Committee, Institutional Biosafety Committees, and the Review Committee on Genetic Manipulation.
3. The committees provide guidance on biosafety, review research proposals, oversee safety training, and ensure containment facilities and procedures are followed to regulate genetic engineering activities and protect
Kirsi-Marja Oksman-Caldentey presented VTT's wide and novel expertise in Industrial Biotechnology in the Polish-Finnish Innovation Forum in Helsinki June 8, 2016.
Biotechnology is being applied across multiple industries in North Carolina, including animal agriculture, aquaculture, defense, energy, environment, forensics, and forestry. Some key applications include improved animal health and breeding, disease resistance in aquaculture, developing defenses against biological weapons, producing sustainable biofuels, environmental remediation, DNA testing for forensics, and increasing forest growth and pest/disease resistance. Biotechnology is providing new tools that are enhancing North Carolina's industries and economy.
Considerations of unintended effects in genome editing applications - Marie-B...OECD Environment
This document discusses considerations of unintended effects from genome editing applications in plants. Genome editing allows for targeted modifications in genomes with high specificity. However, there is still a risk of unintended effects, including off-target modifications and persistence of editing components like nucleases or guide RNAs. Proper assessment of these risks and management measures are needed to prevent potential negative impacts on health or the environment from genome edited plants.
Regulatory Aspects associated to genome editing – U.S. Environmental Protecti...OECD Environment
In September 2016, EPA indicated in the National Strategy for Modernizing the Regulatory System for Biotechnology Products (put forward by the United States EPA, USDA, and FDA) that it intends to clarify its approach to pesticidal products derived from genome editing.
This literature review summarizes research on the use of digestate from anaerobic digestion as a fertilizer or growing media ingredient for protected horticulture crops. The review found studies from the UK and elsewhere that tested whole digestate, separated liquid digestate, and separated solid digestate fiber with soil-grown crops, hydroponic production, and as ingredients in growing media. The evidence suggests that digestates can achieve similar or better crop yields and quality compared to standard practices. However, more research is still needed, especially regarding food safety and optimization of digestate treatments. Wider use of digestates could reduce reliance on peat and inorganic fertilizers in protected horticulture.
Nw biotech fundamentals day 2 session 2 industrial applications and cleantechNicholas Weston Lawyers
In this presentation:
• Definition of Industrial applications and clean-tech
• The technical stages of product development project
• The state of the art – key drivers of innovation
• Regulatory nuances
• Pre-clinical and in the clinic issues
• Future trends
• Challenges and opportunities
• Case studies and examples
The document discusses various US and European regulatory agencies that oversee different aspects of biotechnology. The FDA regulates food additives and drugs. The EPA regulates genetically modified crops and water quality. The EPA, FDA and USDA regulate environmental releases of genetically engineered organisms. Patents regulate drugs by requiring them to be functional with no malfunctions. New streamlined drug approval processes in Europe have reduced approval times from four years to one. Europe has the most applicants for cancer therapy patents because purification steps are often individually patented. Firms should evaluate all aspects of production after the Fluvirin incident highlighted regulatory issues. ESTs cannot be patented because they only identify genetic locations rather than having a specific utility. Drug approvals take less time in
This document discusses plant biopharming, which involves producing recombinant proteins in transgenic plants. It provides an overview of the concept, strategies used, production systems, downstream processing, applications including monoclonal antibodies and edible vaccines, case studies, and biosafety issues. Specifically, it summarizes that plant biopharming is a promising approach for the large-scale, low-cost production of pharmaceuticals due to plants' high protein yields and stability. However, further work is still needed to maximize protein expression, improve purification techniques, evaluate optimal dosages, and enhance biosafety systems to ensure human and environmental safety.
This document discusses the effects of irradiation on food, including how it works to reduce microorganisms and extend shelf-life while maintaining quality. It outlines different irradiation doses and their purposes, such as inhibiting sprouting or reducing pathogens. Several foods currently treated are mentioned, as well as international standards for irradiation as a phytosanitary measure. The document also addresses factors like nutritional value, quality impacts, and regulations regarding labeled of irradiated foods.
The document discusses microalgae as a source of biofuels. It notes that microalgae have the potential to produce more biomass and oil per unit area than other feedstocks. The document outlines the cultivation, harvesting, and processing steps to produce biofuels from microalgae, including biodiesel production via transesterification. While microalgae have promising theoretical yields, achieving these at commercial scale has proven challenging due to the energy and costs required for cultivation, harvesting, and processing of algal biomass.
A variety of fuels can be made from biomassi resources including the liquid fuels ethanol, methanol, biodiesel, Fischer-Tropsch diesel, and gaseous fuels such as hydrogen and methane. Biofuels research and development is composed of three main areas: producing the fuels, applications and uses of the fuels, and distribution infrastructure.
Biofuels are primarily used to fuel vehicles, but can also fuel engines or fuel cells for electricity generation. For information about the use of biofuels in vehicles, see the Alternative Fuel Vehicle page under Vehicles. See the Vehicles page for information about the biofuels distribution infrastructure. See the Hydrogen and Fuel Cells page for more information about hydrogen as a fuel.
Presentation at 2016 Fuel Ethanol Workshop, describing U.S. regulatory pathways for approval of use of modified microorganisms in animal feed, and a proposal for making such pathways simpler and more efficient for modified strains of common microorganisms.
David Glass Presentation at 2016 BIO World CongressDavid Glass
Presentation describing the status of the ongoing efforts to update and modernize the Federal Government's Coordinated Framework for Biotechnology Regulation.
Challenges and Opportunities in Industrial Biotech RegulationDavid Glass
Presentation at Society for Biological Engineering Workshop, "Technology Challenges and Opportunities in Commercializing Industrial Biotechnology", San Diego September 29, 2015.
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.
Next-generation waxy corn – a flagship case of SDN-1/NHEJ genome editing via ...OECD Environment
1) DowDuPont is developing waxy corn varieties using CRISPR/Cas9 genome editing to introduce a targeted mutation in the waxy gene that results in the entire coding sequence being deleted.
2) Trials show the CRISPR-edited waxy corn has identical phenotypes and starch properties as conventional waxy corn varieties.
3) CRISPR-edited waxy corn hybrids have shown improved yields compared to conventional hybrid checks in agronomic trials.
This document discusses the applications of nanotechnology in the food industry. It begins with an introduction and discusses the need for nanotechnology in the food sector. It then covers various applications of nanotechnology including nanoencapsulation, nanoemulsions, nanoparticles for active packaging, nanoclays for packaging, and nanosensors for packaging and processing plants. Specific examples of products that utilize these nanotechnology applications are also provided. The document concludes by noting regulatory considerations for nanotechnology in food.
Presented by Doris Wangari, Program for Biosafety Systems (PBS), Kenya, at the Workshop on Animal Genetic Research for Africa (Biosciences for Farming in Africa), Nairobi, 10-11 September 2015
04 control of spills and mechanism of implementation of biosafety guidelinesIndranil Bhattacharjee
1. The document outlines procedures for controlling spills of biological materials in laboratories, including spills in biological safety cabinets, open laboratories, centrifuges, and on persons. It describes wearing protective equipment, warning others, and using appropriate disinfectants.
2. It then describes the mechanism for implementing biosafety guidelines in India, including committees that provide oversight of recombinant DNA research. The key committees are the Recombinant DNA Advisory Committee, Institutional Biosafety Committees, and the Review Committee on Genetic Manipulation.
3. The committees provide guidance on biosafety, review research proposals, oversee safety training, and ensure containment facilities and procedures are followed to regulate genetic engineering activities and protect
Kirsi-Marja Oksman-Caldentey presented VTT's wide and novel expertise in Industrial Biotechnology in the Polish-Finnish Innovation Forum in Helsinki June 8, 2016.
Biotechnology is being applied across multiple industries in North Carolina, including animal agriculture, aquaculture, defense, energy, environment, forensics, and forestry. Some key applications include improved animal health and breeding, disease resistance in aquaculture, developing defenses against biological weapons, producing sustainable biofuels, environmental remediation, DNA testing for forensics, and increasing forest growth and pest/disease resistance. Biotechnology is providing new tools that are enhancing North Carolina's industries and economy.
Considerations of unintended effects in genome editing applications - Marie-B...OECD Environment
This document discusses considerations of unintended effects from genome editing applications in plants. Genome editing allows for targeted modifications in genomes with high specificity. However, there is still a risk of unintended effects, including off-target modifications and persistence of editing components like nucleases or guide RNAs. Proper assessment of these risks and management measures are needed to prevent potential negative impacts on health or the environment from genome edited plants.
Regulatory Aspects associated to genome editing – U.S. Environmental Protecti...OECD Environment
In September 2016, EPA indicated in the National Strategy for Modernizing the Regulatory System for Biotechnology Products (put forward by the United States EPA, USDA, and FDA) that it intends to clarify its approach to pesticidal products derived from genome editing.
This literature review summarizes research on the use of digestate from anaerobic digestion as a fertilizer or growing media ingredient for protected horticulture crops. The review found studies from the UK and elsewhere that tested whole digestate, separated liquid digestate, and separated solid digestate fiber with soil-grown crops, hydroponic production, and as ingredients in growing media. The evidence suggests that digestates can achieve similar or better crop yields and quality compared to standard practices. However, more research is still needed, especially regarding food safety and optimization of digestate treatments. Wider use of digestates could reduce reliance on peat and inorganic fertilizers in protected horticulture.
Nw biotech fundamentals day 2 session 2 industrial applications and cleantechNicholas Weston Lawyers
In this presentation:
• Definition of Industrial applications and clean-tech
• The technical stages of product development project
• The state of the art – key drivers of innovation
• Regulatory nuances
• Pre-clinical and in the clinic issues
• Future trends
• Challenges and opportunities
• Case studies and examples
The document discusses various US and European regulatory agencies that oversee different aspects of biotechnology. The FDA regulates food additives and drugs. The EPA regulates genetically modified crops and water quality. The EPA, FDA and USDA regulate environmental releases of genetically engineered organisms. Patents regulate drugs by requiring them to be functional with no malfunctions. New streamlined drug approval processes in Europe have reduced approval times from four years to one. Europe has the most applicants for cancer therapy patents because purification steps are often individually patented. Firms should evaluate all aspects of production after the Fluvirin incident highlighted regulatory issues. ESTs cannot be patented because they only identify genetic locations rather than having a specific utility. Drug approvals take less time in
This document discusses plant biopharming, which involves producing recombinant proteins in transgenic plants. It provides an overview of the concept, strategies used, production systems, downstream processing, applications including monoclonal antibodies and edible vaccines, case studies, and biosafety issues. Specifically, it summarizes that plant biopharming is a promising approach for the large-scale, low-cost production of pharmaceuticals due to plants' high protein yields and stability. However, further work is still needed to maximize protein expression, improve purification techniques, evaluate optimal dosages, and enhance biosafety systems to ensure human and environmental safety.
This document discusses the effects of irradiation on food, including how it works to reduce microorganisms and extend shelf-life while maintaining quality. It outlines different irradiation doses and their purposes, such as inhibiting sprouting or reducing pathogens. Several foods currently treated are mentioned, as well as international standards for irradiation as a phytosanitary measure. The document also addresses factors like nutritional value, quality impacts, and regulations regarding labeled of irradiated foods.
The document discusses microalgae as a source of biofuels. It notes that microalgae have the potential to produce more biomass and oil per unit area than other feedstocks. The document outlines the cultivation, harvesting, and processing steps to produce biofuels from microalgae, including biodiesel production via transesterification. While microalgae have promising theoretical yields, achieving these at commercial scale has proven challenging due to the energy and costs required for cultivation, harvesting, and processing of algal biomass.
A variety of fuels can be made from biomassi resources including the liquid fuels ethanol, methanol, biodiesel, Fischer-Tropsch diesel, and gaseous fuels such as hydrogen and methane. Biofuels research and development is composed of three main areas: producing the fuels, applications and uses of the fuels, and distribution infrastructure.
Biofuels are primarily used to fuel vehicles, but can also fuel engines or fuel cells for electricity generation. For information about the use of biofuels in vehicles, see the Alternative Fuel Vehicle page under Vehicles. See the Vehicles page for information about the biofuels distribution infrastructure. See the Hydrogen and Fuel Cells page for more information about hydrogen as a fuel.
These slides use concepts from my (Jeff Funk) course entitled analyzing hi-tech opportunities to examine the increasing economic feasibility of algae biofuels. Algae can be grown in places where traditional crops cannot be grown and it consumes carbon dioxide, thus making it better than traditional sources of biofuels. It can also be harvested every 10 days thus making its oil yield per acre 200 times higher than corn and 40 times higher than sunflowers. The problem is that harvesting and extracting the algae requires large amounts of labor and energy (drying) and the algae may damage surrounding eco-systems. Thus new and better processes along with large scale production are needed to solve these problems. These slides discuss the various approaches (open pond, photo-bioreactor, fermentation), their advantages and disadvantages, their existing and future costs, and other improvements that are driving steadily falling costs. In the short term, algae will continue to be used in niche applications such as cosmetics, food, and fertilizers. In the long run, as the cost reductions continue, algae might become a major source of fuel for transportation and other applications.
This document discusses different types of biofuels including their production, uses, and benefits. It describes first, second, and third generation biofuels made from sources like sugar, starch, non-edible plant materials, and algae. Specific biofuels covered include biodiesel, biogas, bioalcohols, and syngas. Biodiesel production through trans-esterification is explained. Feedstocks and outputs for biodiesel are listed. Benefits of biodiesel include being cleaner burning and having less sulfur than diesel fuel.
algal biofuels with challenges and opportunitiesbhushan bhusare
This document provides an overview of biofuels from algae, including a history of algae biofuel research, types of biofuels that can be produced from algae, advantages of using algae over other feedstocks, cultivation methods, harvesting techniques, and the process of converting algae biomass to biodiesel via transesterification. Key points covered include that algae have a high oil content and growth rate, can be grown on non-arable land or wastewater, and have the potential to generate up to 40 times more oil per acre than terrestrial crops used for biofuel production.
Algae have potential as a biofuel feedstock due to their ability to grow rapidly and produce high lipid content. However, challenges remain in developing a cost-effective cultivation and harvesting system, as well as efficiently extracting the oil. Different cultivation methods like open ponds or photobioreactors provide varying levels of environmental control. Once harvested, algae can be processed to extract oil through mechanical or chemical means, though high production costs currently limit commercial viability. Further technological advances may help overcome these challenges and make algae a competitive renewable fuel source.
Bio-fuel are the fuel of biological origin these constitute renewable from of energy.Energy crisis
Based on the current consumption of about 11.6 million tons of crude oil per day, it is expected that the entire resources can only suffice for a rather short time period.
Global warming and global climate changes
The use of oil can cause the risks of the rise of greenhouse effect, which can result in all kinds of disasters to our planet Earth and its inhabitants
This document summarizes the current status of algal biofuel production and methods to intensify production. It discusses how algal biofuels can help address issues with fossil fuel consumption and emissions. Microalgae have advantages over land crops for biofuel production, including rapid growth rates and ability to use non-arable land and wastewater. Key steps in algal biofuel production include cultivating microalgae, harvesting, lipid extraction, and transesterification to produce biodiesel. A variety of cultivation and extraction methods are discussed, along with their impacts on lipid yields. Ultrasound and microwave-assisted extraction methods show promise for more efficient lipid recovery from algal biomass.
This document discusses the potential for algae as a source of biofuel. It begins with an introduction to biofuels and why algae is a promising feedstock. The production process is then outlined, including growing algae photobioreactors or open ponds, extracting the oil, and converting it into fuels. While current production costs remain high, the document explains various areas for improvement that could substantially reduce costs over time. It also explores entrepreneurial opportunities in algae beyond just fuels, such as for food, chemicals and building materials. In conclusion, algae biofuel is seen as a very promising alternative to fossil fuels if production can be scaled up cost effectively.
The document describes several experiments related to protein analysis:
1. It provides procedures for preparing phosphate and acetate buffers, estimating protein concentration using Lowry's method, determining the absorption maximum of riboflavin, performing paper chromatography to separate amino acids, and titrating acetic acid to find its pKa value.
2. It also outlines protocols for purifying protein from a sample via ammonium sulfate precipitation and estimating the precipitated protein, separating amino acids from a mixture using ion exchange chromatography, and performing SDS-PAGE to separate proteins by molecular weight.
3. Reagents, materials, and step-by-step procedures are described for each experiment to analyze different properties of proteins and separate mixtures of
The document discusses algae biofuel as a promising alternative fuel source. It provides information on the advantages of algae biofuel such as its high yield per acre and ability to use wastewater. The document also discusses challenges such as the need for large-scale sustainable algae production and efficient oil extraction methods. It outlines the key steps in the potential algae biofuel production process and value chain.
Intro of Micro-organisms, Bacteria, Use of bacteria, Harmful bacteria,Reproduction in bacteria, virus,
Reproduction in virus, Fungi, Use of fungi, Harmful fungi,
Reproduction in fungi
Algae has potential as a sustainable biofuel feedstock due to its high growth yields and ability to grow in wastewater. However, significant challenges remain in developing algae-based biofuels including high costs of production. While algae can remove nutrients from wastewater, more research is needed to improve algal growth rates and lipid yields. Additional processing steps like dewatering algae are also energy intensive and expensive. For algae to become commercially viable as transportation fuel, further reductions in production costs through technology advances will be required.
biofuel is clean and green sourece of energy, climatchange is global problem people are looking for clean source of energy.global enegy problem can be minimised by the use of biofuel.
The document discusses air pollution and its control through biotechnology. It begins with an introduction to air pollution, listing common air pollutants such as particulates and gaseous pollutants. It then describes several methods for estimating pollutants and controlling air pollution, including the use of biotechnology approaches like microalgal photosynthesis and biological calcification to reduce carbon dioxide in the atmosphere. The document concludes with a summary of the causes and impacts of air pollution and the need for continued control efforts.
From Algae to Biofuels: An Integrated System Approach to Renewable Energy ZY8
This document summarizes the key findings from a National Algal Biofuels Technology Roadmap Workshop held in 2008:
- The workshop brought together over 200 experts to identify challenges to producing algal biofuels commercially.
- While algae have potential advantages as a feedstock, scaling up cultivation and processing into affordable, sustainable fuels faces major technical hurdles.
- The roadmap documents these challenges across the entire supply chain from algal strain selection to conversion processes.
- The goal is to guide further research, partnerships, and policy to enable commercial production of algal biofuels.
This document discusses unicellular and multicellular organisms. Unicellular organisms are made of only one cell and include bacteria, amoebas, and unicellular fungi and yeasts. They are microscopic and need to be seen with a microscope. Multicellular organisms are made of two or more cells and include humans, cats, dogs, insects, trees and more. They can be seen with the naked eye and need all parts to survive. Examples are given of both unicellular and multicellular organisms.
Multi and single celled organisms comparisonsKati W
This document compares and contrasts single-celled and multi-celled organisms. Single-celled organisms like bacteria and amoebas consist of only one cell, while multi-celled organisms like plants and animals are made of many cells that work together. Examples of single-celled organisms are given as algae, amoeba and paramecium. Multi-celled organisms develop from a single cell and then organize into tissues and organs, as in the case of humans who start as a single cell and differentiate into three germ layers that form the major body systems.
Application of industrial BiotechnologyGhassan Hadi
The document discusses industrial biotechnology and microbial technology. Microbial technology uses microbes to produce products and services of economic value. It involves isolating microbes, screening them for product formation, improving yields, culturing and harvesting products. Microbes are used to produce metabolites, treat waste, control pests and pathogens, and ferment food. They can enhance nutrient availability as biofertilizers. Microbes also recover metals from ores and desulfurize coal. New technologies allow ethanol to be produced from crop residues rather than just grains. Industrial biotechnology and microbial technology have benefits like low substrate input, high output, environmental friendliness, renewability, and increased efficiency.
1. Water is essential for life and supports all living organisms, but it can become polluted from various human and natural sources.
2. Microorganisms play important roles in water, including as primary producers, decomposers, and indicators of water quality. Phytoplankton, zooplankton, periphyton, benthos, and saprotrophic bacteria and fungi are some of the main types of microorganisms found in water.
3. Water pollution occurs when waste disposal or other human activities change the physical or chemical properties of water, making it unsuitable for uses like drinking, agriculture, or recreation. Sources of water pollution include industrial, domestic, agricultural, and mining activities.
U.S. and International Regulation of Microbial Inoculants and Soil AdditivesDavid Glass
Presentation at the International Phytobiomes Conference, September 2012, Denver, Colorado. The talk describes US and international regulation that might affect the testing and development of modified microorganisms for nonpesticidal uses in agriculture, such as biofertilizers or certain biostimulants.
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.
David Glass Algae Biomass Final 10.03.22.pdfDavid Glass
The document discusses strategies for obtaining regulatory approval to use algae and cyanobacteria for chemical and fuel production. It provides an overview of the potential industrial uses of photosynthetic microorganisms, as well as strategies companies are taking to genetically modify algae and cyanobacteria for increased productivity. The document then focuses on US EPA regulation of industrial biotechnology under the Toxic Substances Control Act, and what activities require EPA approval. It also discusses regulatory risk assessment and provides examples of regulatory approvals that companies have received for field testing and commercial use of modified algae and cyanobacteria.
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.
The document outlines India's national biosafety policies and guidelines over time. It begins with the need for biosafety regulation to safeguard biological resources from indiscriminate use of technologies. India's biosafety policy timeline is then described, starting from the 1980s with recombinant DNA technology. Key guidelines are summarized, including the 1990 Recombinant DNA Safety Guidelines, 1998 Guidelines for Research in Transgenic Plants, 1999 Guidelines for Generating Data for rDNA Vaccines and Diagnostics, 2008 Guidelines for Safety Assessment of GE Food and Guidelines for Confined Field Trials of GE Plants. The document provides an overview of India's development of biosafety laws and policies to regulate emerging biotechnologies.
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
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)
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.
1) The document discusses biosafety and bioethics issues related to microbial technology and biotechnology. It addresses concerns about genetically modified organisms (GMOs) and their impact on human health and the environment.
2) Good manufacturing practices (GMP) are guidelines that ensure products are consistently high quality and safe. They cover all aspects of production to minimize risks.
3) Proper rules and regulations around biosafety are important and vary depending on the organism and its intended use. Biosafety and gaining public trust are crucial to the development and application of biotechnology.
Dr Dev Kambhampati | Nanotech & Human Food Guidance FDADr Dev Kambhampati
This document provides guidance for manufacturers and users of food ingredients and food contact substances on assessing the effects of significant manufacturing process changes. It discusses factors to consider in determining if a change affects the identity, safety or regulatory status of a substance. The guidance recommends consulting FDA regarding changes, especially those involving emerging technologies like nanotechnology. It also directs readers to other FDA guidance documents that provide recommendations for submitting safety data to support new uses of food substances.
This document discusses the FDA's perspective on regulating cellular therapies. It provides the following key points:
1. The FDA regulates cellular therapies as drugs, biological products, and human cells/tissues under various regulations including cGMP, biological product regulations, labeling regulations, and HCT/P regulations.
2. Cellular therapies present challenges for development and regulation due to their complex nature involving living cells.
3. The document provides tips for navigating FDA regulations during development, including being data-driven, providing complete documentation, being informed of FDA resources, communicating with the FDA, and planning ahead.
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
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.
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.
Regulatory requirement for approval of BiologicsArpitha Aarushi
The document is a presentation on regulatory requirements for approval of biologics submitted by Arpitha B. M. to Dr. D. Manjula. It contains an introduction, history of biologics regulation citing key events, sources and types of biologics, differences between biologics and chemical drugs, the regulatory approval process including biological license application, and references. The presentation provides an overview of biologics, their regulation and approval process in India.
The document discusses regulations for human cells, tissues, and cellular and tissue-based products (HCT/Ps) established by the U.S. Food and Drug Administration (FDA) under 21 CFR Part 1271. It provides an overview of the key requirements including establishment registration and listing, donor eligibility screening, adherence to current good tissue practice standards, inspection and enforcement, and the tiered regulatory framework for HCT/Ps. It also compares the new regulations to existing cGMP and quality system regulations.
The document outlines India's regulatory framework for transgenic crops. It discusses the various guidelines and committees involved in regulating genetic engineering experiments and ensuring biosafety. The key committees mentioned are the Genetic Engineering Approval Committee (GEAC), Review Committee on Genetic Manipulation (RCGM), Institutional Biosafety Committee (IBSC), State Biotechnology Co-ordination Committee (SBCC), and District Level Committee (DLC). Experiments involving genetic modification are classified into three categories based on risk level and require approval from the appropriate committees.
The document discusses three basic steps for organic producers and handlers to ensure compliant use of materials under the USDA's National Organic Program:
1. Understand the relevant NOP regulations by reviewing the full standards and identifying sections that address allowed and prohibited materials for your type of operation.
2. Create an Organic System Plan listing all materials to be used and obtain approval from your certifier before using any materials.
3. Document all material purchases and applications, and retain records for at least five years.
Following these three steps helps operations use materials correctly according to the standards and avoids issues that could require restarting the three-year transition to organic certification.
This document discusses three steps for ensuring compliant use of materials for organic production and handling according to the USDA's National Organic Program. First, operators must understand the relevant NOP regulations regarding allowed and prohibited materials. Second, operators must include all materials in their Organic System Plan and get approval from their certifier. Third, operators must document all material purchases and uses and keep records for at least five years. Following these steps helps ensure materials are used correctly according to organic standards.
Similar to David Glass Presentation at 2010 Algae Biomass Summit (20)
zkStudyClub - LatticeFold: A Lattice-based Folding Scheme and its Application...Alex Pruden
Folding is a recent technique for building efficient recursive SNARKs. Several elegant folding protocols have been proposed, such as Nova, Supernova, Hypernova, Protostar, and others. However, all of them rely on an additively homomorphic commitment scheme based on discrete log, and are therefore not post-quantum secure. In this work we present LatticeFold, the first lattice-based folding protocol based on the Module SIS problem. This folding protocol naturally leads to an efficient recursive lattice-based SNARK and an efficient PCD scheme. LatticeFold supports folding low-degree relations, such as R1CS, as well as high-degree relations, such as CCS. The key challenge is to construct a secure folding protocol that works with the Ajtai commitment scheme. The difficulty, is ensuring that extracted witnesses are low norm through many rounds of folding. We present a novel technique using the sumcheck protocol to ensure that extracted witnesses are always low norm no matter how many rounds of folding are used. Our evaluation of the final proof system suggests that it is as performant as Hypernova, while providing post-quantum security.
Paper Link: https://eprint.iacr.org/2024/257
Monitoring and Managing Anomaly Detection on OpenShift.pdfTosin Akinosho
Monitoring and Managing Anomaly Detection on OpenShift
Overview
Dive into the world of anomaly detection on edge devices with our comprehensive hands-on tutorial. This SlideShare presentation will guide you through the entire process, from data collection and model training to edge deployment and real-time monitoring. Perfect for those looking to implement robust anomaly detection systems on resource-constrained IoT/edge devices.
Key Topics Covered
1. Introduction to Anomaly Detection
- Understand the fundamentals of anomaly detection and its importance in identifying unusual behavior or failures in systems.
2. Understanding Edge (IoT)
- Learn about edge computing and IoT, and how they enable real-time data processing and decision-making at the source.
3. What is ArgoCD?
- Discover ArgoCD, a declarative, GitOps continuous delivery tool for Kubernetes, and its role in deploying applications on edge devices.
4. Deployment Using ArgoCD for Edge Devices
- Step-by-step guide on deploying anomaly detection models on edge devices using ArgoCD.
5. Introduction to Apache Kafka and S3
- Explore Apache Kafka for real-time data streaming and Amazon S3 for scalable storage solutions.
6. Viewing Kafka Messages in the Data Lake
- Learn how to view and analyze Kafka messages stored in a data lake for better insights.
7. What is Prometheus?
- Get to know Prometheus, an open-source monitoring and alerting toolkit, and its application in monitoring edge devices.
8. Monitoring Application Metrics with Prometheus
- Detailed instructions on setting up Prometheus to monitor the performance and health of your anomaly detection system.
9. What is Camel K?
- Introduction to Camel K, a lightweight integration framework built on Apache Camel, designed for Kubernetes.
10. Configuring Camel K Integrations for Data Pipelines
- Learn how to configure Camel K for seamless data pipeline integrations in your anomaly detection workflow.
11. What is a Jupyter Notebook?
- Overview of Jupyter Notebooks, an open-source web application for creating and sharing documents with live code, equations, visualizations, and narrative text.
12. Jupyter Notebooks with Code Examples
- Hands-on examples and code snippets in Jupyter Notebooks to help you implement and test anomaly detection models.
Discover top-tier mobile app development services, offering innovative solutions for iOS and Android. Enhance your business with custom, user-friendly mobile applications.
The Microsoft 365 Migration Tutorial For Beginner.pptxoperationspcvita
This presentation will help you understand the power of Microsoft 365. However, we have mentioned every productivity app included in Office 365. Additionally, we have suggested the migration situation related to Office 365 and how we can help you.
You can also read: https://www.systoolsgroup.com/updates/office-365-tenant-to-tenant-migration-step-by-step-complete-guide/
What is an RPA CoE? Session 1 – CoE VisionDianaGray10
In the first session, we will review the organization's vision and how this has an impact on the COE Structure.
Topics covered:
• The role of a steering committee
• How do the organization’s priorities determine CoE Structure?
Speaker:
Chris Bolin, Senior Intelligent Automation Architect Anika Systems
Have you ever been confused by the myriad of choices offered by AWS for hosting a website or an API?
Lambda, Elastic Beanstalk, Lightsail, Amplify, S3 (and more!) can each host websites + APIs. But which one should we choose?
Which one is cheapest? Which one is fastest? Which one will scale to meet our needs?
Join me in this session as we dive into each AWS hosting service to determine which one is best for your scenario and explain why!
Generating privacy-protected synthetic data using Secludy and MilvusZilliz
During this demo, the founders of Secludy will demonstrate how their system utilizes Milvus to store and manipulate embeddings for generating privacy-protected synthetic data. Their approach not only maintains the confidentiality of the original data but also enhances the utility and scalability of LLMs under privacy constraints. Attendees, including machine learning engineers, data scientists, and data managers, will witness first-hand how Secludy's integration with Milvus empowers organizations to harness the power of LLMs securely and efficiently.
[OReilly Superstream] Occupy the Space: A grassroots guide to engineering (an...Jason Yip
The typical problem in product engineering is not bad strategy, so much as “no strategy”. This leads to confusion, lack of motivation, and incoherent action. The next time you look for a strategy and find an empty space, instead of waiting for it to be filled, I will show you how to fill it in yourself. If you’re wrong, it forces a correction. If you’re right, it helps create focus. I’ll share how I’ve approached this in the past, both what works and lessons for what didn’t work so well.
Essentials of Automations: Exploring Attributes & Automation ParametersSafe Software
Building automations in FME Flow can save time, money, and help businesses scale by eliminating data silos and providing data to stakeholders in real-time. One essential component to orchestrating complex automations is the use of attributes & automation parameters (both formerly known as “keys”). In fact, it’s unlikely you’ll ever build an Automation without using these components, but what exactly are they?
Attributes & automation parameters enable the automation author to pass data values from one automation component to the next. During this webinar, our FME Flow Specialists will cover leveraging the three types of these output attributes & parameters in FME Flow: Event, Custom, and Automation. As a bonus, they’ll also be making use of the Split-Merge Block functionality.
You’ll leave this webinar with a better understanding of how to maximize the potential of automations by making use of attributes & automation parameters, with the ultimate goal of setting your enterprise integration workflows up on autopilot.
HCL Notes and Domino License Cost Reduction in the World of DLAUpanagenda
Webinar Recording: https://www.panagenda.com/webinars/hcl-notes-and-domino-license-cost-reduction-in-the-world-of-dlau/
The introduction of DLAU and the CCB & CCX licensing model caused quite a stir in the HCL community. As a Notes and Domino customer, you may have faced challenges with unexpected user counts and license costs. You probably have questions on how this new licensing approach works and how to benefit from it. Most importantly, you likely have budget constraints and want to save money where possible. Don’t worry, we can help with all of this!
We’ll show you how to fix common misconfigurations that cause higher-than-expected user counts, and how to identify accounts which you can deactivate to save money. There are also frequent patterns that can cause unnecessary cost, like using a person document instead of a mail-in for shared mailboxes. We’ll provide examples and solutions for those as well. And naturally we’ll explain the new licensing model.
Join HCL Ambassador Marc Thomas in this webinar with a special guest appearance from Franz Walder. It will give you the tools and know-how to stay on top of what is going on with Domino licensing. You will be able lower your cost through an optimized configuration and keep it low going forward.
These topics will be covered
- Reducing license cost by finding and fixing misconfigurations and superfluous accounts
- How do CCB and CCX licenses really work?
- Understanding the DLAU tool and how to best utilize it
- Tips for common problem areas, like team mailboxes, functional/test users, etc
- Practical examples and best practices to implement right away
Fueling AI with Great Data with Airbyte WebinarZilliz
This talk will focus on how to collect data from a variety of sources, leveraging this data for RAG and other GenAI use cases, and finally charting your course to productionalization.
HCL Notes und Domino Lizenzkostenreduzierung in der Welt von DLAUpanagenda
Webinar Recording: https://www.panagenda.com/webinars/hcl-notes-und-domino-lizenzkostenreduzierung-in-der-welt-von-dlau/
DLAU und die Lizenzen nach dem CCB- und CCX-Modell sind für viele in der HCL-Community seit letztem Jahr ein heißes Thema. Als Notes- oder Domino-Kunde haben Sie vielleicht mit unerwartet hohen Benutzerzahlen und Lizenzgebühren zu kämpfen. Sie fragen sich vielleicht, wie diese neue Art der Lizenzierung funktioniert und welchen Nutzen sie Ihnen bringt. Vor allem wollen Sie sicherlich Ihr Budget einhalten und Kosten sparen, wo immer möglich. Das verstehen wir und wir möchten Ihnen dabei helfen!
Wir erklären Ihnen, wie Sie häufige Konfigurationsprobleme lösen können, die dazu führen können, dass mehr Benutzer gezählt werden als nötig, und wie Sie überflüssige oder ungenutzte Konten identifizieren und entfernen können, um Geld zu sparen. Es gibt auch einige Ansätze, die zu unnötigen Ausgaben führen können, z. B. wenn ein Personendokument anstelle eines Mail-Ins für geteilte Mailboxen verwendet wird. Wir zeigen Ihnen solche Fälle und deren Lösungen. Und natürlich erklären wir Ihnen das neue Lizenzmodell.
Nehmen Sie an diesem Webinar teil, bei dem HCL-Ambassador Marc Thomas und Gastredner Franz Walder Ihnen diese neue Welt näherbringen. Es vermittelt Ihnen die Tools und das Know-how, um den Überblick zu bewahren. Sie werden in der Lage sein, Ihre Kosten durch eine optimierte Domino-Konfiguration zu reduzieren und auch in Zukunft gering zu halten.
Diese Themen werden behandelt
- Reduzierung der Lizenzkosten durch Auffinden und Beheben von Fehlkonfigurationen und überflüssigen Konten
- Wie funktionieren CCB- und CCX-Lizenzen wirklich?
- Verstehen des DLAU-Tools und wie man es am besten nutzt
- Tipps für häufige Problembereiche, wie z. B. Team-Postfächer, Funktions-/Testbenutzer usw.
- Praxisbeispiele und Best Practices zum sofortigen Umsetzen
For the full video of this presentation, please visit: https://www.edge-ai-vision.com/2024/06/how-axelera-ai-uses-digital-compute-in-memory-to-deliver-fast-and-energy-efficient-computer-vision-a-presentation-from-axelera-ai/
Bram Verhoef, Head of Machine Learning at Axelera AI, presents the “How Axelera AI Uses Digital Compute-in-memory to Deliver Fast and Energy-efficient Computer Vision” tutorial at the May 2024 Embedded Vision Summit.
As artificial intelligence inference transitions from cloud environments to edge locations, computer vision applications achieve heightened responsiveness, reliability and privacy. This migration, however, introduces the challenge of operating within the stringent confines of resource constraints typical at the edge, including small form factors, low energy budgets and diminished memory and computational capacities. Axelera AI addresses these challenges through an innovative approach of performing digital computations within memory itself. This technique facilitates the realization of high-performance, energy-efficient and cost-effective computer vision capabilities at the thin and thick edge, extending the frontier of what is achievable with current technologies.
In this presentation, Verhoef unveils his company’s pioneering chip technology and demonstrates its capacity to deliver exceptional frames-per-second performance across a range of standard computer vision networks typical of applications in security, surveillance and the industrial sector. This shows that advanced computer vision can be accessible and efficient, even at the very edge of our technological ecosystem.
Main news related to the CCS TSI 2023 (2023/1695)Jakub Marek
An English 🇬🇧 translation of a presentation to the speech I gave about the main changes brought by CCS TSI 2023 at the biggest Czech conference on Communications and signalling systems on Railways, which was held in Clarion Hotel Olomouc from 7th to 9th November 2023 (konferenceszt.cz). Attended by around 500 participants and 200 on-line followers.
The original Czech 🇨🇿 version of the presentation can be found here: https://www.slideshare.net/slideshow/hlavni-novinky-souvisejici-s-ccs-tsi-2023-2023-1695/269688092 .
The videorecording (in Czech) from the presentation is available here: https://youtu.be/WzjJWm4IyPk?si=SImb06tuXGb30BEH .
David Glass Presentation at 2010 Algae Biomass Summit
1. Impact of Government Biotechnology Regulations on Use of Genetically Modified or Synthetic Algae in Biofuel Production David J. Glass, Ph.D. D. Glass Associates, Inc. Algae Biomass Summit September 28, 2010
2. Biotechnologies Applicable to Biofuels Classical mutation and selection Plant breeding Recombinant DNA Directed evolution DNA shuffling Metabolic engineering Synthetic biology
3. Applications of Biotechnology to Clean Fuel Production Enhanced or engineered microorganisms for fermentation of ethanol, butanol, other fuels. Enzymes for fuel production manufactured using engineered microorganisms or plants. Selected or engineered plant species for use as improved biofuel feedstocks. Improved algal strains for production of biodiesel, jet fuel, ethanol, other fuels.
4. Genetic Engineering Strategies: Algae Enhance algal growth rate. Enhance or alter lipid biosynthesis. Enhance photosynthesis. Enable use of alternate food sources. Create new biosynthetic pathways. Enable secretion of lipids to aid oil/water separation.
5. Scientific Issues in the Regulation of Modified Algae Legitimate scientific issues need to be addressed for many projects involving modified algal strains. Stability of vector and introduced genes. Possible deleterious functions encoded by transgene(s). Potential for horizontal gene transfer, crossing to wild algae species. Potential for engineered strain to be transported outside facility, survive and compete in environment.
6. Overview of U.S. Biotechnology Regulation Environmental Protection Agency Microbial pesticides, plant pesticides. Engineered microorganisms used for other industrial purposes. U.S. Department of Agriculture Transgenic plants, potential plant pests. Plant-produced industrial products. Food and Drug Administration Foods, food additives, pharmaceuticals Possible applicability to algae TSCA biotech rule USDA biotech rule Product –specific regulation
7. Overview: EPA TSCA Biotechnology Regulations Regulations under the Toxic Substances Control Act (TSCA). Regulations cover industrial uses of “intergeneric” microorganisms not regulated by other agencies; e.g. industrial enzyme production, bioprocessing. Scope of coverage could include algae. Most research and pilot projects are not regulated if suitably “contained”. Commercial use or importation requires 90 day advance notification to EPA.
8. Overview: USDA Biotechnology Regulations Regulations issued in 1987 cover environmental uses, interstate movement of “potential plant pests”. Applicability to algae under current definitions not clear. Rules have generally not covered “contained” use of organisms in manufacturing. USDA has been considering revisions to the rule since 2007. Regulatory program being challenged in the courts over NEPA compliance.
9. Overview: FDA Biotechnology Regulations Engineered algae used for food, food additive, pharmaceutical production would be subject to FDA product-specific regulations. These regulations focus more on safety, efficacy of end product, and less on risks of production organism. Algae used for an FDA-regulated purpose would likely be exempt from EPA oversight under TSCA.
10. Regulatory Jurisdiction for Engineered Algae Proposed use of engineered algae by Mera Pharmaceuticals in pharmaceutical production in Hawaii in 2005 generated controversy, no federal agency claimed jurisdiction: state law and state courts ultimately determined outcome. 2008 USDA opinion letter to Coastal BioMarine stated no USDA oversight over engineered algal strain if no “plant pest” sequences, and no oversight for smaller-scale use in contained reactors. It is important to avoid jurisdictional disputes as the industry moves forward.
11. EPA TSCA Biotechnology Rule:“New Organism” Definition TSCA covers only “new chemicals”, so Biotech Rule covers only “new microorganisms”. “New microorganisms” defined as “intergeneric”: i.e., containing deliberate combinations of coding nucleic acids from more than one taxonomic genus. Many recombinant microorganisms will not meet this definition, and not be covered by these rules.
12. EPA TSCA Biotechnology Rule:R&D (“Small Quantities”) Exemption R&D uses of “new microorganisms” may qualify for exemption, if used “solely for R&D” in a suitably “contained structure”. Applicant must adopt procedures at the facility for controlled access, inactivation of wastes, emission controls, worker notification. Exemption could apply to R&D by for-profit entities, including pilot plants. Open-pond algae reactors may not be judged to be “contained structures”. Non-contained uses may require EPA notification, review prior to commencement.
13. EPA TSCA Biotechnology Rule: Microbial Commercial Activity Notifications (MCANs) Commercial use or importation of “new microorganisms” requires MCAN reporting at least 90 days before commencing commercialization or importing microbe. MCAN requires submission of data to EPA. Microorganism identity, construction and its properties. Information about the industrial process, control/containment measures, worker exposure, possible environmental release. EPA review, clearance of MCAN authorizes commercial use.
14. EPA TSCA Biotechnology Rule:Biofuel, Bio-Based Chemical MCANs 29 MCANs reviewed since 1997, including: Numerous MCANs for industrial enzymes. Modified E. coli and Klebsiella oxytoca for the conversion of lignocellulosic biomass sugars to ethanol (Verenium, 2008, 2010). “Biopolymer producing organism” for the industrial manufacture of a biopolymer (Company Confidential, 2008). Modified Zymomonas mobilis for cellulosic ethanol production (DuPont, 2009).
15. EPA TSCA Biotechnology Rule:Summary Most R&D would be exempt if “contained”. Commercial uses require 90 day advance notice. EPA has a track record in recent years reviewing microorganisms for use in biofuels, bio-based chemical production. EPA review considers risks and benefits. MCAN review clears the way for commercial use. EPA review is generally considered to meet requirements under NEPA, so Environmental Impact Statement not needed.
16. USDA Biotechnology Regulation:Scope of Coverage USDA Biotech Regulations administered by Animal and Plant Health Inspection Service (APHIS). Rules cover organisms that are potential plant pests, generally based on presence of DNA sequences from potential plant pests. Rules cover environmental use or interstate movement of potential plant pest organisms. Most submissions have been for transgenic plants, some for modified agricultural microorganisms.
17. USDA Biotechnology Regulation:Oversight over R&D R&D use covered only if in open environment. Notifications: 30 day advance notice. Permits: submit application 120 days in advance. Permits generally required for industrial uses. Submissions require: Description of host organism and genetic modifications. Description of field test; proposed procedures and controls. Assess environmental impact of field use.
18. USDA Biotechnology Regulation:Approvals for Commercial Use Approval for commercial use and sale through “petitions for nonregulated status”. Since early 1990s, USDA has approved 78 petitions to allow commercial sale of engineered crop plants. Approvals can take 1-4 years. Recent court cases have ruled that these approvals may require Environmental Impact Statements.
19. USDA Biotechnology Regulation:Summary Tens of thousands of field tests approved under these regulations – no approvals for algae? Limited experience with R&D permits for novel biofuel feedstocks, no commercial approvals. USDA likely to have scientific expertise to review biology of photosynthetic algae, but applicability under existing definitions unclear. Uncertain future for these regulations, due to ongoing rulemaking and court decisions regarding NEPA compliance.
20. Environmental Impact Statements? National Environmental Policy Act (NEPA) requires Environmental Assessments, Environmental Impact Statements, for “major federal actions”. Courts have ruled that product approvals under USDA biotech regulation require EIS’s. EPA actions under most of its regulations considered to inherently comply with NEPA requirements. Recent calls for DOE to conduct EIS for its program supporting algal biofuel research. Question: are EIS’s needed, and if so, when?
21. ABO Technical Standards Committee: Goals Published in Initial Draft Set the terms of the debate; encourage responsible, science-based regulation. Distinguish between different biotechnologies used to create organisms. Develop standards for data submission, performance of production facilities, organism containment. Develop a “road map” for regulatory approval of industrial uses of modified algae. Influence public perception.
22. ABO Technical Standards Committee: Challenges to Achieving Goals Biotech regulations use longstanding definitions to define which organisms are covered; would be difficult to introduce new classification schemes. Regulations differ in performance standards, data requirements and review procedures; standardization would be easier if one agency had sole jurisdiction. Growth of GM algae in open ponds. Public perception is critical. Although not as bad as the 1980s, there are still many vocal critics out there.
23. Impact of Biotechnology Regulations Efforts to promote standardization, interagency cooperation are important to ensure a science-based regulatory framework. However, the existing biotech regulatory framework provides a straightforward path to commercial approval, with many prior successes in agricultural, industrial biotechnology. The regulatory process can be successfully managed with proper advance planning.
24. Thank you very much David J. Glass, Ph.D. D. Glass Associates, Inc. 124 Bird Street Needham, MA 02492 Phone 617-653-9945 DGlassAssc@aol.com www.dglassassociates.com http://dglassassociates.wordpress.com