Preparing for Future Products of Biotechnology (2017) / Chapter Skim
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3 The Current Biotechnology Regulatory System
3 The Current Biotechnology Regulatory System
Pages 67-106
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From page 67... ...
The 2017 update to the Coordinated Framework (EOP, 2017) devotes less attention to these issues than to environmental risks, so the committee opted to examine consumer- and occupational-safety issues in depth in this chapter before introducing the key statutes related to environmental risks, which lay groundwork for more detailed discussion of environmental risk analysis that follows in Chapters 4 and 5 of this report.
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From page 68... ...
After a brief overview of the origins and evolution of the Coordinated Framework, the chapter addresses the statutory authorities and associated agency responsibilities for accomplishing the Coordinated Framework's objectives with regard to safety: protection of human health -- including consumer and occupational safety -- and protection of the environment. It identifies the capacity of the agencies to regulate future biotechnology products under their existing authorities and points out areas where the limits of their authorities may leave gaps in oversight.
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From page 69... ...
. The Coordinated Framework Federal involvement in the oversight of biotechnology is generally viewed as originating in the 1970s.
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From page 70... ...
Later in the 1970s and early 1980s, amid growing prospects that DNA research would produce a flood of new products, Congress considered but did not adopt various proposals to enact unified biotechnology legislation. In 1984, the White House Cabinet Council on Natural Resources and the Environment formed a Working Group on Biotechnology, which proposed a Coordinated Framework that would clarify regulatory responsibility to federal agencies acting under their existing statutory authorities (OSTP, 1986)
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From page 71... ...
The intent of the Coordinated Framework is to provide mechanisms to assess the safety of biotechnology products while simultaneously offering a framework for advancing innovation and increasing transparency, coordination, efficiency, and predictability. This balance is sought in the interpretation of the statutory authorities that make up the Coordinated Framework.
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From page 72... ...
USDA Plant Protection Act (PPA) Protect agricultural plants and agriculturally important natural resources from damage caused by organisms that pose plant pest or noxious weed risks.
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From page 73... ...
. These programs, however, are neither focused nor scaled to address the risks of diverse biotechnology consumer products expected in coming years, and existing consumer-safety regulators like FDA, CPSC, and EPA lack statutory tools to take on this responsibility.
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From page 74... ...
Statutes also allocate responsibilities surrounding generation of safety information, by identifying who is responsible for conducting studies to assess risks and resolve the scientific uncertainties that can surround regulatory decisions involving novel biotechnology products. A statute may foster safety studies by the product sponsors (manufacturers, distributors, or sellers)
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From page 75... ...
8 • Can the regulator require product sponsors to conduct safety studies and clinical trials in the post-marketing period to clarify signals of new safety risks? Provisions to Foster Private-Sector Participation in Creating Evidence and Data Infrastructure for Risk Analysis and Setting Safety Standards In regulatory frameworks, the participation of private-sector actors goes beyond simply requiring product sponsors and developers to generate risk information about their own commercial products.
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From page 76... ...
As shown in Table 3-1, USDA plays a crucial role in consumer safety with respect to various food products, such as meat and poultry. Federal oversight of consumer and occupational safety is not limited to the three agencies discussed in the 2017 update to the Coordinated Framework (EOP, 2017)
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From page 77... ...
, food ingredients that are generally recognized as safe (GRAS) , food additives, medical foods, infant formula, pesticide and environmental contaminants in food, dietary supplements, cosmetics, tobacco products, new animal drugs, and animal food.
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From page 78... ...
do not require premarket approval as food additives. Dietary Supplement Manufacturers and distributors (sponsors)
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From page 79... ...
The and manage post-marketing safety risks, and can on other product burden of proof is on the product sponsor (the require sponsors to report safety information and, definitions) manufacturer)
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From page 80... ...
Through careful exercise of this discretion, the agency has significant power to position products under the risk-assessment framework best suited to the task of protecting human safety while still fostering beneficial innovation. Biotechnology Foods, Food Additives, and Dietary Supplements Food products derived from genetically engineered (GE)
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From page 81... ...
New food additives cannot be sold until FDA determines they are safe, and product sponsors must produce evidence of safety and await FDA approval before they can be marketed. Ingredients that are GRAS do not require premarket approval as food additives.
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From page 82... ...
FDA thus has various tools, under its existing statutes, to address safety concerns that novel biotechnology food products may present in the coming 5–10 years. First, if FDA determines that it needs to adapt its 1992 policy and consultation process for food derived from GE or genomeengineered plant varieties, the agency can do so without any further congressional action.
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From page 83... ...
An important part of risk assessment, therefore, is to ensure that any nutritional and health claims about biotechnology foods are accurate -- or, if they are scientifically uncertain, to ensure the uncertainty is properly disclosed. FDA has several ways to protect consumers from false or misleading claims about foods and dietary supplements, including those that are derived from or produced through biotechnology.18 First, the 1990 Nutrition Labeling and Education Act (NLEA)
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From page 84... ...
They suggest that a more effective approach is to address underlying societal concerns, such as the existence of industries (for example, dog fighting) that promote the inappropriate enhancement of deleterious 20In addition to FDA's authority to regulate new animal drugs under the Federal Food, Drug, and Cosmetic Act, USDA has authority to regulate biologic medicines used in animals under the Virus-Serum-Toxin Act of 1913 and related statutes.
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From page 85... ...
Diffusion of research to DIYbio and smaller, noninstitutional research settings potentially may move research outside the centralized, NIH-led research oversight process that has been a central pillar of the Coordinated Framework. The NIH guidelines detail safety practices and containment procedures for basic and clinical research involving recombinant or synthetic nucleic acid molecules, including the creation and use of organisms and viruses containing recombinant or synthetic nucleic acid molecules.
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From page 86... ...
CPSC's jurisdiction to regulate biotechnology consumer products thus is a residual, gap-filling jurisdiction over products that fail to fall under the jurisdiction of other Coordinated Framework agencies. CPSC does not regulate pesticides,28 tobacco products,29 drugs, devices, or cosmetics subject to FDA regulation,30 or food.31 As a result, FDA's decisions about whether products fit into its own jurisdiction can have the effect of shrinking or expanding the list of products that CPSC regulates.
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From page 87... ...
Occupational Safety and Health Administration Many future biotechnology products are intended not as final consumer products but instead would be used as means of production in diverse industrial, commercial, and agricultural settings. Such products may pose risks primarily to workers rather than to consumers of the final marketed products, in which case OSHA would be the primary safety regulator.
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From page 88... ...
. Because of these various judicial, procedural, and political constraints, some commenters feel that regulation under the Occupational Safety and Health Act will have difficulty protecting workers effectively from risks related to novel biotechnology products (Mendeloff, 1988; Shapiro and McGarity, 1989; Lin, 2013)
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From page 89... ...
. Appropriate staffing and resources are thus crucial, both to reap the full benefits that the 2016 amendments offer and to avoid regulatory bottlenecks that threaten to slow innovation as the flood of new products anticipated in Chapter 2 confronts TSCA's new premarket-notification requirements.
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From page 90... ...
Synthetic food products, such as synthesized meat and eggs produced without the intermediation of animals, appear to fall outside the definitions of non-GE meat and egg products that FSIS regulates and responsibility for the safety of such products would lie primarily with FDA. ENVIRONMENTAL PROTECTION This section discusses environmental regulation of biotechnology products by EPA under FIFRA and TSCA and by USDA under the Plant Protection Act and Animal Health Protection Act (Table 3-3)
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From page 91... ...
EPA also has the flexibility under FIFRA to reassess a registration decision at any time if new information suggests the probability of adverse effects may be greater than what was originally estimated. EPA Intergeneric Toxic Substances For field trials, product developers submit a TSCA microorganism Control Act (TSCA)
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From page 92... ...
regulates biotechnology products under the Plant Protection Act (PPA) , which protects plants and plant products from plant pests and noxious weeds, and under the Animal Health Protection Act (AHPA)
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From page 93... ...
genetically engineered for population suppression under the FDCA.45 Jurisdictional Gaps and Redundancies Jurisdictional gaps are one of the major challenges that future biotechnology products pose to the existing scheme of environmental regulation under FIFRA, TSCA, PPA, and AHPA. Gaps occur if a biotechnology organism falls outside the definitions of products that can be regulated under those statutes and, therefore, does not receive premarket or post-market oversight and fails to receive environmental assessment (Box 3-3)
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From page 94... ...
on the host organism, the intended phenotype, whether there is an intention to move or release the product, the intended genetic change in the final product (for example, insertion, deletion, or substitution of genetic material) , a description of the vector or vector agent used to induce genetic change in the organism (for example, biolistic delivery, Agrobacterium-mediated, or site-specific nuclease)
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From page 95... ...
One way to address these sorts of gaps is for EPA to exercise authority under TSCA. In the 1986 Coordinated Framework, TSCA was described as a "back-stop" authority that could be applied to any biotechnology organism that did not fall under other authorities.
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From page 96... ...
For instance, USDA–APHIS has shown greater emphasis on the use of environmental assessments as a means to avoid the more costly and time-consuming environmental impact statements, and this is reflected in more comprehensive risk assessments even though decisions are still ultimately focused on plant-pest considerations. For products that fall under USDA–APHIS's purview under the Plant Protection Act, significant federal actions that may trigger NEPA include permittingb and deregulation of products.
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Accessed September 30, 2016. dFor drugs and animal drugs, FDA's regulatory oversight begins when the product developer opens an investigational new drug (or investigational new animal drug)
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From page 98... ...
SUMMARY AND CONCLUSIONS The Coordinated Framework for Regulation of Biotechnology is a complex collection of statutes and regulations that provide the basis for federal oversight of biotechnology products. The Coordinated Framework appears to have considerable flexibility to cover a wide range of biotechnology products, although in some cases the agencies' jurisdiction has been defined in ways that
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From page 99... ...
Even when the statutes technically do allow agencies to regulate these products, the current statutes equip the regulators with tools that may, at times, make it hard for them to regulate the products effectively. For example, the statutes may not empower regulators to require product sponsors to share in the burden of generating information about product safety, may place the burden of proof on regulators to demonstrate that a product is unsafe before they can take action to protect the public, or may require cumbersome processes or procedures the regulators must follow before they can act, and almost all of the statutes lack adequate legal authority for post-marketing surveillance, monitoring, and continuous learning approaches.
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From page 100... ...
Conclusion 3-2: The Consumer Product Safety Act and the Occupational Safety and Health Act do not provide CPSC and OSHA with legal authorities and tools that are well tailored to the challenges of regulating novel biotechnology-based consumer products and means of production. CPSC lacks authority to conduct premarket safety analysis of biotechnology-based consumer products and has limited tools for responding to risks emerging after products are marketed.
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From page 101... ...
are neither focused nor scaled to address concerns that may arise in connection with future consumer products. The future industry structure will include new players, such as do-it-yourself and at-home biotechnology enthusiasts and product developers, nontraditional manufacturers, and those entering the biotechnology space with support from nontraditional funding sources for research.
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From page 102... ...
Fish and Wildlife Service or the National Marine Fisheries Service, they do not have the authority to make regulatory decisions based on the findings of the environmental assessment or environmental impact statement. As of 2016, most existing biotechnology products have been used in contained environments or open environments in managed systems, but with more biotechnology products designed for released into open environments with minimal or no management, this disconnect may be more acute.
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From page 103... ...
2017. Modernizing the Regulatory System for Biotechnology Products: An Update to the Coordinated Framework for the Regulation of Biotechnology.
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From page 104... ...
2016. NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (NIH Guidelines)
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From page 105... ...
Webinar presentation to the National Academies of Sciences, Engineering, and Medicine Committee on Future Biotechnology Products and Opportunities to Enhance Capabilities of the Biotechnology Regulatory System, July 21.
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