Academic literature on the topic 'United States. Biotechnology, Biologics, and Environmental Protection'
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Journal articles on the topic "United States. Biotechnology, Biologics, and Environmental Protection"
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Yu, Peter K. "Data Exclusivities in the Age of Big Data, Biologics, and Plurilaterals." Texas A&M Law Review 6, no. 4 (January 2019): 22–33. http://dx.doi.org/10.37419/lr.v6.arg.2.
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The past decade has seen many new developments impacting the intellectual property system. The introduction of big data analytics has transformed the fields of biotechnology and bioinformatics while ushering in major advances in drug development, clinical practices, and medical financing. The arrival of biologics and personalized medicines has also revolutionized the healthcare and pharmaceutical industries. In addition, the emergence of bilateral, regional, and plurilateral trade agreements have raised serious, and at times difficult, questions concerning the evolution of domestic and international intellectual property standards. One topic linking all three developments together concerns the establishment of international standards to protect clinical trial data that have been submitted to regulatory authorities for the marketing approval of pharmaceutical products. During the negotiations for the Trans-Pacific Partnership (TPP), for example, the protection of clinical trial data submitted for the marketing approval of biologics was highly contentious. Although the United States’ withdrawal in January 2017 has since placed the TPP Agreement and its data exclusivity provisions for pharmaceuticals and biologics on life support, the debate on the protection of clinical trial data will continue and will emerge in future bilateral, regional, and plurilateral trade negotiations, including the renegotiations on the North American Free Trade Agreement (NAFTA). Part I of this Article reviews the protection of clinical trial data under Article 39.3 of the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS Agreement) of the World Trade Organization (WTO). Even though the provision covers both pharmaceutical and agricultural chemical products, this Article focuses only on the former. Part II examines the additional protection clinical trial data have received through TRIPS-plus bilateral, regional, and plurilateral trade agreements. Part III outlines five specific recommendations to help advance the debate on such protection in the age of big data, biologics, and plurilateral trade agreements.
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Heled, Yaniv. "The Case for Disclosure of Biologics Manufacturing Information." Journal of Law, Medicine & Ethics 47, S4 (2019): 54–78. http://dx.doi.org/10.1177/1073110519898043.
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Ten years after the enactment of the Biologics Price Competition and Innovation Act (BPCIA), competition in biologics markets remains scant and far from sufficient for lowering prices of biologics to the level of 80-90% price drops seen in generic drug markets. This reality is not a result of one or two cardinal reasons, but many. If lowering the price of biologics is the goal and competition is the means by which we seek to achieve that goal, then there does not seem to be a quick fix to address all of the many impediments to competition that plague biologics markets. Yet, certain changes to how the Food and Drug Administration (FDA) evaluates and approves biologics may go a long way toward the creation of meaningful competition in biologics markets. One such change would be making original biologics' manufacturing information available to follow-on manufacturers.As recognized by several commentators, access to biologics manufacturing information is key to increasing competition in biologics markets. Without access to such information, making follow-on biologics is difficult and expensive, if not outright impossible. This is expected to be especially true for the highly anticipated class of interchangeable biologics, none of which has been approved by the FDA to date. Yet, it has long been the position of the brand-name pharmaceutical industry (Industry) that biologics manufacturing information is proprietary and, thus, may not be shared. Congress has subscribed to the Industry's position, prohibiting the FDA from disclosing regulatory filings submitted by developers of original biologics, including manufacturing information, to third parties. That prohibition not only undermines competition in biologics markets, but is also wasteful, potentially unethical, and poses unnecessary risks to the health and safety of patients.This article makes the case for FDA sharing of original biologics manufacturing information with follow-on biologics developers. It is informed by the similar legal and commercial circumstances in the area of pesticides and the regulatory regime established by Congress in the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA), which is administered by the Environmental Protection Agency (EPA). The article reviews the FIFRA regime, including its upholding as constitutional by the United States Supreme Court, and then examines its applicability to the area of biologics. The article concludes with a proposal for a similar regime to be incorporated into the pathway for approval of follow-on biologics as a means of increasing competition in biologics markets.
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McCuin, Randi M., and Jennifer L. Clancy. "Modifications to United States Environmental Protection Agency Methods 1622 and 1623 for Detection of Cryptosporidium Oocysts and Giardia Cysts in Water." Applied and Environmental Microbiology 69, no. 1 (January 2003): 267–74. http://dx.doi.org/10.1128/aem.69.1.267-274.2003.
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ABSTRACT Collaborative and in-house laboratory trials were conducted to evaluate Cryptosporidium oocyst and Giardia cyst recoveries from source and finished-water samples by utilizing the Filta-Max system and U.S. Environmental Protection Agency (EPA) methods 1622 and 1623. Collaborative trials with the Filta-Max system were conducted in accordance with manufacturer protocols for sample collection and processing. The mean oocyst recovery from seeded, filtered tap water was 48.4% ± 11.8%, while the mean cyst recovery was 57.1% ± 10.9%. Recovery percentages from raw source water samples ranged from 19.5 to 54.5% for oocysts and from 46.7 to 70.0% for cysts. When modifications were made in the elution and concentration steps to streamline the Filta-Max procedure, the mean percentages of recovery from filtered tap water were 40.2% ± 16.3% for oocysts and 49.4% ± 12.3% for cysts by the modified procedures, while matrix spike oocyst recovery percentages ranged from 2.1 to 36.5% and cyst recovery percentages ranged from 22.7 to 68.3%. Blinded matrix spike samples were analyzed quarterly as part of voluntary participation in the U.S. EPA protozoan performance evaluation program. A total of 15 blind samples were analyzed by using the Filta-Max system. The mean oocyst recovery percentages was 50.2% ± 13.8%, while the mean cyst recovery percentages was 41.2% ± 9.9%. As part of the quality assurance objectives of methods 1622 and 1623, reagent water samples were seeded with a predetermined number of Cryptosporidium oocysts and Giardia cysts. Mean recovery percentages of 45.4% ± 11.1% and 61.3% ± 3.8% were obtained for Cryptosporidium oocysts and Giardia cysts, respectively. These studies demonstrated that the Filta-Max system meets the acceptance criteria described in U.S. EPA methods 1622 and 1623.
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Lasalde, Clarivel, Roberto Rodríguez, and Gary A. Toranzos. "Statistical Analyses: Possible Reasons for Unreliability of Source Tracking Efforts." Applied and Environmental Microbiology 71, no. 8 (August 2005): 4690–95. http://dx.doi.org/10.1128/aem.71.8.4690-4695.2005.
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ABSTRACT Analyses for the presence of indicator organisms provide information on the microbiological quality of water. Indicator organisms recommended by the United States Environmental Protection Agency for monitoring the microbiological quality of water include Escherichia coli, a thermotolerant coliform found in the feces of warm-blooded animals. These bacteria can also be isolated from environmental sources such as the recreational and pristine waters of tropical rain forests in the absence of fecal contamination. In the present study, E. coli isolates were compared to E. coli K12 (ATCC 29425) by restriction fragment length polymorphism using pulsed-field gel electrophoresis. Theoretically, genomic DNA patterns generated by PFGE are highly specific for the different isolates of an organism and can be used to identify variability between environmental and fecal isolates. Our results indicate a different band pattern for almost every one of the E. coli isolates analyzed. Cluster analysis did not show any relations between isolates and their source of origin. Only the discriminant function analysis grouped the samples with the source of origin. The discrepancy observed between the cluster analysis and discriminant function analysis relies on their mathematical basis. Our validation analyses indicate the presence of an artifact (i.e., grouping of environmental versus fecal samples as a product of the statistical analyses used and not as a result of separation in terms of source of origin) in the classification results; therefore, the large genetic heterogeneity observed in these E. coli populations makes the grouping of isolates by source rather difficult, if not impossible.
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Thurston-Enriquez, Jeanette A., Charles N. Haas, Joseph Jacangelo, and Charles P. Gerba. "Chlorine Inactivation of Adenovirus Type 40 and Feline Calicivirus." Applied and Environmental Microbiology 69, no. 7 (July 2003): 3979–85. http://dx.doi.org/10.1128/aem.69.7.3979-3985.2003.
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ABSTRACT Ct values, the concentration of free chlorine multiplied by time of contact with virus, were determined for free-chlorine inactivation experiments carried out with chloroform-extracted (dispersed) and non-chloroform-extracted (aggregated) feline calicivirus (FCV), adenovirus type 40 (AD40), and polio virus type 1 (PV-1). Experiments were carried out with high and low pH and temperature conditions. Ct values were calculated directly from bench-scale free-chlorine inactivation experiments and from application of the efficiency factor Hom model. For each experimental condition, Ct values were higher at pH 8 than at pH 6, higher at 5°C than at 15°C, and higher for dispersed AD40 (dAD40) than for dispersed FCV (dFCV). dFCV and dAD40 were more sensitive to free chlorine than dispersed PV-1 (dPV-1). Cts for 2 log inactivation of aggregated FCV (aFCV) and aggregated PV-1 (aPV-1) were 31.0 and 2.8 orders of magnitude higher than those calculated from experiments carried out with dispersed virus. Cts for 2 log inactivation of dFCV and dAD40 in treated groundwater at 15°C were 1.2 and 13.7 times greater than in buffered-demand-free (BDF) water experiments at 5°C. Ct values listed in the U.S. Environmental Protection Agency (EPA) Guidance Manual were close to, or lower than, Ct values generated for experiments conducted with dispersed and aggregated viruses suspended in BDF water and for dispersed viruses suspended in treated groundwater. Since the state of viruses in water is most likely to be aggregated and associated with organic or inorganic matter, reevaluation of the EPA Guidance Manual Ct values is necessary, since they would not be useful for ensuring inactivation of viruses in these states. Under the tested conditions, dAD40, dFCV, aFCV, dPV-1, and aPV-1 particles would be inactivated by commonly used free chlorine concentrations (1 mg/liter) and contact times (60 to 237 min) applied for drinking water treatment in the United States.
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Percent, Sascha F., Marc E. Frischer, Paul A. Vescio, Ellen B. Duffy, Vincenzo Milano, Maggie McLellan, Brett M. Stevens, Charles W. Boylen, and Sandra A. Nierzwicki-Bauer. "Bacterial Community Structure of Acid-Impacted Lakes: What Controls Diversity?" Applied and Environmental Microbiology 74, no. 6 (February 1, 2008): 1856–68. http://dx.doi.org/10.1128/aem.01719-07.
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ABSTRACT Although it is recognized that acidification of freshwater systems results in decreased overall species richness of plants and animals, little is known about the response of aquatic microbial communities to acidification. In this study we examined bacterioplankton community diversity and structure in 18 lakes located in the Adirondack Park (in the state of New York in the United States) that were affected to various degrees by acidic deposition and assessed correlations with 31 physical and chemical parameters. The pH of these lakes ranged from 4.9 to 7.8. These studies were conducted as a component of the Adirondack Effects Assessment Program supported by the U.S. Environmental Protection Agency. Thirty-one independent 16S rRNA gene libraries consisting of 2,135 clones were constructed from epilimnion and hypolimnion water samples. Bacterioplankton community composition was determined by sequencing and amplified ribosomal DNA restriction analysis of the clone libraries. Nineteen bacterial classes representing 95 subclasses were observed, but clone libraries were dominated by representatives of the Actinobacteria and Betaproteobacteria classes. Although the diversity and richness of bacterioplankton communities were positively correlated with pH, the overall community composition assessed by principal component analysis was not. The strongest correlations were observed between bacterioplankton communities and lake depth, hydraulic retention time, dissolved inorganic carbon, and nonlabile monomeric aluminum concentrations. While there was not an overall correlation between bacterioplankton community structure and pH, several bacterial classes, including the Alphaproteobacteria, were directly correlated with acidity. These results indicate that unlike more identifiable correlations between acidity and species richness for higher trophic levels, controls on bacterioplankton community structure are likely more complex, involving both direct and indirect processes.
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Thompson, Channing C., and Rebecca Y. Lai. "Threonine Phosphorylation of an Electrochemical Peptide-Based Sensor to Achieve Improved Uranyl Ion Binding Affinity." Biosensors 12, no. 11 (November 2, 2022): 961. http://dx.doi.org/10.3390/bios12110961.
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We have successfully designed a uranyl ion (U(VI)-specific peptide and used it in the fabrication of an electrochemical sensor. The 12-amino acid peptide sequence, (n) DKDGDGYIpTAAE (c), originates from calmodulin, a Ca(II)-binding protein, and contains a phosphothreonine that enhances the sequence’s affinity for U(VI) over Ca(II). The sensing mechanism of this U(VI) sensor is similar to other electrochemical peptide-based sensors, which relies on the change in the flexibility of the peptide probe upon interacting with the target. The sensor was systematically characterized using alternating current voltammetry (ACV) and cyclic voltammetry. Its limit of detection was 50 nM, which is lower than the United States Environmental Protection Agency maximum contaminant level for uranium. The signal saturation time was ~40 min. In addition, it showed minimal cross-reactivity when tested against nine different metal ions, including Ca(II), Mg(II), Pb(II), Hg(II), Cu(II), Fe(II), Zn(II), Cd(II), and Cr(VI). Its reusability and ability to function in diluted aquifer and drinking water samples were further confirmed and validated. The response of the sensor fabricated with the same peptide sequence but with a nonphosphorylated threonine was also analyzed, substantiating the positive effects of threonine phosphorylation on U(VI) binding. This study places emphasis on strategic utilization of non-standard amino acids in the design of metal ion-chelating peptides, which will further diversify the types of peptide recognition elements available for metal ion sensing applications.
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Rubio-Garcia, Javier, Daniel Malko, Anthony R. J. Kucernak, Martin Kaiser, and Andres Parra-Puerto. "Cleaning Industrial Waste Water with Simultaneous Power Generation Utilizing an Abiotic Fuel Cell." ECS Meeting Abstracts MA2018-01, no. 31 (April 13, 2018): 1820. http://dx.doi.org/10.1149/ma2018-01/31/1820.
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Wastewater streams contain organic molecules that need to be removal before disposal which requires an energy input on average of 6 kWh ton-1. (1) The fermentation of biomass to produce biogas employs living organisms and permits the valorization of the waste with generation of electricity. However, this technology present limitations in terms of capital cost (ranging USD0.06 and USD0.30 as a function of the size of the digester) and large volume footprint. (2) Microbial fuel cells (MFCs) offer the ability significantly reducing the Chemical Oxygen Demand (COD) contamination is waste water effluents while produce moderate amounts of power. (3) In this contribution, we present the first abiotic waste water fuel cell, a system that directly converts organic materials found in waste sources from different industries into electrical energy. The implementation of inorganic catalysts permits a so-called zero gap design which contributes to minimize the distance between the anode and cathode which is normally large for MFCs to minimize oxygen crossover. This configuration was combined with a commercial PtRu oxidation catalysts produced an unprecedented high power density when using real waste water streams (2.6 mW cm-2). Moreover, when operated in a continuous loop COD removals as high as 50% has been achieved. This abiotic system significantly reduces processing time associated to incubation periods which are necessary for bio-processes such as biogas generation. (4) References: (1) United States Environmental Protection Agency, Local Government Climate and Energy Strategy Series (2008). (2) Weiland et al., Applied Microbiology and Biotechnology 85, 849-860 (2010). (3) Liu et al., Environmental Science & Technology 38, 4040-4046 (2004). (4) Mao et al., Renewable & Sustainable Energy Reviews 45, 540-555 (2015).
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Fuentes, Esai, Cheyenne Wickham, Carlos Carbajal, Christian Lopez, Suzzette Jauregui, Raul Lechler, Sonia Gutierrez, et al. "Genesis of Antibiotic Resistance XXVII: Action plan for Global Union for Antibiotics Research and Development (GUARD) to mitigate AR pandemic (ARP)." FASEB Journal 31, S1 (April 2017). http://dx.doi.org/10.1096/fasebj.31.1_supplement.777.9.
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A retrospective analysis of data concerned with the regulation of the transport of animals for caged animal feeding operations (feedlots) and the availability and use of antibiotics was accomplished from data available from an aggregation of domestic and global agencies. Agency data sources included are the United States Department of Agriculture‐Animal Plant Health Inspection System (USDA‐APHIS), the Environmental Protection Agency (EPA), the United States Geological Survey (USGS), Center for Disease Control and Prevention (CDC), Food and Drug Administration (FDA), Customs and Border Protection‐Eagle Pass Sector (CBP), Drug Enforcement Administration (DEA), Texas Water Development Board‐Laredo, Texas, (TWDB), Texas Commission on Environmental Quality‐Laredo, Texas, (TCEQ), Organization for Economic Cooperation and Development (OECD), Asia Pacific Economic Cooperation (APEC), European Centre for Disease Prevention and Control (ECDC), European Medicines Agency (EMEA), Food and Agriculture Organization (FAO), World Organization for Animal Health (OIE), Transatlantic Taskforce on Antimicrobial Resistance (TATFAR), World Health Organization (WHO), and Central Drugs Standard Control Organization (CDSCO). Based on the analysis, an action plan is proposed for the Global Union for Antibiotics Research and Development[1][2][3](GUARD) to mitigate AR pandemic (ARP). The primary suggestion is the immediate establishment of a centralized database that will serve as an open‐ended system for reporting, monitoring and control, education, and information sharing in the following processes: i. Antibiotics prescription details by name of disease and dosage, ii. Amount of antibiotics produced per country and per capita, including utilization of antibiotics per country and per capita. Implementation of antibiotics time out (ATO), iii. Detection of active pharmaceutical ingredients (API) in soil and water, iv. Streamlining of the disposal of antibiotics by universal and global disposal standards (Best Available Techniques), v. Maintain a global monitoring system for emergence of AR pathogen induced infectious diseases on twenty‐four‐hour and seven day cycles, vi. Mandatory cyclic reporting (quarterly, semiannual, and annual) regarding morbidity and mortality rates due to AR pathogens, vii. Mandatory annual summit to address threats of emergence and spread of AR infectious diseases, viii. Generate global trust fund to create resources for mitigation of the AR, ix. Global implementation‐success rate of Antibiotics Timeout (ATO), x. Creation of a Pharmaco‐Ecotoxicology data sheet for “Bioaccumulation potential of antibiotics, its active pharmaceutical ingredients (API) in the non‐target organisms (aquatic, terrestrial, avian species) and Environmental risk assessment for biological response using multi‐biomarker approach. Taken together, a collective effort addressing the aforesaid suggestions on a global scale would plausibly mitigate ARP. Data analysis and adequate literature sources will be presented at EB 2017.Support or Funding InformationProfessional development funds to Subburaj Kannan
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Mendelsohn, Michael, Amanda A. Pierce, and Wiebke Striegel. "U.S. EPA oversight of pesticide traits in genetically modified plants and recent biotechnology innovation efforts." Frontiers in Plant Science 14 (February 23, 2023). http://dx.doi.org/10.3389/fpls.2023.1126006.
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Before pesticides can be sold in the United States, the United States Environmental Protection Agency (EPA) must evaluate them thoroughly to ensure that they meet U.S. federal pesticide registration standards for human health and the environment. EPA considers pesticidal substances produced and used in plants as pesticides and defined them in the regulations as “plant-incorporated protectants” (PIPs). PIPs that are created through conventional breeding are exempted from registration requirements, while those created through biotechnology require individual assessments and approval by EPA before they can be distributed or used. This currently includes PIPs that are identical to those that could be moved through conventional breeding but are created through biotechnology (e.g., through genome editing or via precision breeding techniques). EPA proposed an exemption in October 2020 to allow certain PIPs created through biotechnology to be exempt from EPA requirements for pesticides where those PIPs: 1) pose no greater risk than PIPs that EPA has already exempted, and 2) could have otherwise been created through conventional breeding.
Books on the topic "United States. Biotechnology, Biologics, and Environmental Protection"
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United States. Biotechnology, Biologics, and Environmental Protection. Strategic plan: Biotechnology, biologics, and environmental protection. Washington, D.C.?]: U.S. Dept. of Agriculture, Animal and Plant Health Inspection Service, 1989.
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United States. General Accounting Office. RCED. Biotechnology regulation. Washington, D.C: The Office, 1992.
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Ismailov, Nariman, Samira Nadzhafova, and Aygyun Gasymova. Bioecosystem complexes for the solution of environmental, industrial and social problems (on the example of Azerbaijan). ru: INFRA-M Academic Publishing LLC., 2020. http://dx.doi.org/10.12737/1043239.
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A key objective of the modern development of society is the observance of ecological and socio-economic unity in human life
and comprehensive improvement of environment and quality of life should be considered in close connection with the quality of the natural landscape. The formation of scientific understanding of the unity of society and nature is driven by the need for practical implementation of such unity. This defines the focus of this monograph. Given the overall assessment of the current state of the environment in Azerbaijan, considers the scenarios for the future development of the area. The prospects of the use of biotechnology in integrated environmental protection. In the framework of the above to address complex social, environmental and production problems in Azerbaijan developed scientific basis of integrated system of industrial farms — biclusters with a closed production cycle through effective utilization of regional biological resources,
whose interactions and relationships take on the character of vzaimodeistvie components for obtaining focused final result with high practical importance. Microbiological, biochemical
and technological processes are the basis of all development of biotechnology. Presents the development will help strengthen the ties between science and production, establishing mechanisms to conduct applied research in the field of innovation and creation of knowledge-based technologies in solving current and future environmental problems in Azerbaijan.
We offer innovative ideas distinguishes the potential need for their materialization into new products, technologies and services, including the widespread use of digital technologies to design dynamic digital environmental map in space and in time.
For students, scientific and engineering-technical workers, students and specializing in environmental technology, environmental protection.
Book chapters on the topic "United States. Biotechnology, Biologics, and Environmental Protection"
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Darch, Heather, and Arash Shahsavarani. "The Regulation of Organisms Used in Agriculture Under the Canadian Environmental Protection Act, 1999." In Regulation of Agricultural Biotechnology: The United States and Canada, 137–45. Dordrecht: Springer Netherlands, 2012. http://dx.doi.org/10.1007/978-94-007-2156-2_8.
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Matten, Sharlene R., Robert J. Frederick, and Alan H. Reynolds. "United States Environmental Protection Agency Insect Resistance Management Programs for Plant-Incorporated Protectants and Use of Simulation Modeling." In Regulation of Agricultural Biotechnology: The United States and Canada, 175–267. Dordrecht: Springer Netherlands, 2012. http://dx.doi.org/10.1007/978-94-007-2156-2_11.
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