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Regulatory Affairs
Published in John M. Centanni, Michael J. Roy, Biotechnology Operations, 2016
John M. Centanni, Michael J. Roy
Biologicals, including biotechnology products used to treat or prevent disease in domestic animals, are largely regulated by the U.S. Department of Agriculture (USDA) and not by the FDA. However, the Center for Veterinary Medicine (CVM) of the FDA is designated for animal drugs and medicated feeds. CVM reviews marketing applications, ensuring such products are safe and effective for their intended use. The process is similar to that applied to human drugs, and includes the need to file an Investigational New Animal Drug (INAD) exemption to support investigational use or a New Animal Drug Application (NADA) to receive product-marketing approval. Animal feeds, both those that contain medications, such as antibiotics, and those without supplements, are under the purview of CVM, because they should not contain harmful substances and must be properly labeled. Biotechnology-derived products could fall under both the medicated and nonmedicated classifications of animal feeds, and these products must receive marketing approval from CVM.
Environmental Considerations
Published in Hillary S. Egna, Claude E. Boyd, Dynamics of POND Aquaculture, 2017
Wayne K. Seim, Claude E. Boyd, James S. Diana
The presence of specific substances regulated by EPA may also restrict discharges. National Water Quality Criteria documents are issued by EPA for individual substances, such as dissolved oxygen, ammonia, temperature, specific metals, etc. (EPA, 1986a, 1986b). The state must respond by following the directives in these documents, which list short-term and long-term “safe” levels for individual pollutants that must be met in receiving waters. The limits may vary in relation to water quality of the receiving water. For instance, ammonia no-effect levels vary with stream pH. Waters that have unique species or especially high values in water quality are given more stringent regulatory attention. The state issues permits if these criteria can be achieved. If unsafe or illegal residues might occur in plant or animal products produced within the culture process or in organisms in receiving waters and consumed by humans, then Federal Food, Drug, and Cosmetic Act regulations may restrict such residues. Those restrictions extend to residues in the fish cultured that otherwise meet legal requirements but might result in secondary contamination of some other agricultural product via contribution as a feed or feed supplement. In general, drugs are regulated by the U.S. FDA under the Federal Food, Drug, and Cosmetic Act. FDAs Center for Veterinary Medicine (CVM) is specifically responsible for manufacture, distribution, and use of animal drugs (Federal Joint Subcommittee on Aquaculture, 1994). Pesticides, including disinfectants, are regulated by U.S. EPA under the Federal Fungicide, Insecticide, and Rodenticide Act (FIFRA), which requires pesticide registration and enforces labeling and application methods. Users may also have to be certified to apply specific pesticides.
Regulating animals with gene drive systems: lessons from the regulatory assessment of a genetically engineered mosquito
Published in Journal of Responsible Innovation, 2018
The FDA has claimed regulatory authority over certain GE animals (including insects that are not plant pests) by evoking the FFDCA, the CFRB and the FDA’s own Guidance (2009). The 2009 Guidance delineates the agency’s regulatory policy for GE animals, including insects. The Guidance (2009) treats GE animals as ‘new animal drugs’ (NADs) because the intentionally altered genomic DNA introduced in the animals is meant to impact their bodily structure or function. The FFDCA construes as a drug all non-food articles that are meant ‘to affect the structure or any function of the body of man or other animals’ (21 U.S. Code 321, section 201(g)). Developers of GE animals must submit a new animal drug application (NADA) to the FDA’s Center for Veterinary Medicine (CVM). The NADA applies to the intentionally altered genomic DNA in the animal. Thus, the agency regulates the article in the GE animal, not the GE animal as a whole (FDA-CVM 2009; revised 2015 & 2017, 6), despite using language suggesting regulation of the animal as a whole (FDA-CVM 2009, 7; see also Meghani 2017b). Under the current FDA regulatory system, animals with gene drives would be classified as NADs.
A roadmap for gene drives: using institutional analysis and development to frame research needs and governance in a systems context
Published in Journal of Responsible Innovation, 2018
J. Kuzma, F. Gould, Z. Brown, J. Collins, J. Delborne, E. Frow, K. Esvelt, D. Guston, C. Leitschuh, K. Oye, S. Stauffer
For example, many GE animals are (and will be) subject to regulation by FDA under the New Animal Drug (NAD) provisions of the Federal Drug and Cosmetic Act. With the exceptions of plant pests and organisms that act as pesticides, GE animals will fall under the FDA (as of September 2017). For example, FDA’s new guidance #236 from October 2017 splits transgenic mosquitos: those designed to treat disease would fall under FDA’s authority for NADs and those designed for general pest reduction (including population suppression for disease control) under EPA’s pesticide regulations. Gene drive animals that come under FDA as ‘animal drugs’ would be formally reviewed for the safety of the gene construct to the animal and the efficacy of the gene for population suppression (see Meghani and Kuzma 2017, this volume). Broader ecosystem risks, like loss of prey for predators, or public health harms, like temporary rises in mosquito populations, are not technically part of the legal authority of FDA’s NAD review, although they are procedurally considered under the National Environmental Policy Act. This example shows how a scope rule limits the actors in the action arena to certain decisions. However, non-governmental actors, such as the non-profits and academics developing gene drives, would not be limited to this scope. Several times, workshop participants stressed the need to consider not only direct environmental and health risks, but also indirect ecosystem effects, socioeconomic impacts, and cultural impacts. Projects underway on gene drives are broadening the scope of governance questions beyond formal regulatory authority (Target Malaria 2017; Leitschuh et al. 2017, this volume); thus adding to the scope rules of the action arena.