Preparing for Future Products of Biotechnology (2017) / Chapter Skim
Currently Skimming:
1 Introduction and Context
1 Introduction and Context
Pages 15-26
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From page 15... ...
, and the authorities granted under those statutes provided regulatory oversight jurisdiction for one or more of those federal agencies for all existing or foreseen biotechnology products at the time. IMPETUS FOR THE STUDY Between 1973 and 2016, the ways to manipulate DNA to endow new characteristics in an organism (that is, biotechnology)
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From page 16... ...
This increase has, in due course, expanded the types and number of products that could be developed through biotechnology. For its purposes, the committee defined biotechnology products as products developed through genetic engineering or genome engineering (including products where the engineered DNA molecule is itself the "product," as in an engineered molecule used as a DNA information-storage medium)
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The study was sponsored by EPA, FDA, and USDA.2 INFORMATION-GATHERING ACTIVITIES National Academies committees often invite speakers to make presentations in order to gather information relevant to the study's statement of task. The Committee on Future Biotechnology Products and Opportunities to Enhance Capabilities of the Biotechnology Regulatory System heard from 74 speakers over the course of three in-person meetings and eight webinars.
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From page 18... ...
Written comments could also be submitted to the committee at any time during the study process.5 The comments were reviewed by the committee and are also archived in the study's public access file. Additionally, the committee reviewed several National Academies reports that addressed aspects of future biotechnology products.
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From page 19... ...
For simplicity, the committee focused on three primary categories of actors or participants: product developers, whether these are traditional companies, small- and medium-sized enterprises, the do-it-yourself biology (DIYbio) community, or even individuals; regulatory agencies, including EPA, FDA, and USDA, but also other relevant agencies such as the Consumer Product Safety Commission and the Occupational Safety and Health Administration; and representatives of society and the public, including universities and other research organizations who might develop new biotechnology techniques, nongovernmental organizations that may be supporting or opposing specific biotechnology techniques and products, and international organizations, governments, and treaty authorities.
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From page 20... ...
The top and bottom horizontal arrows reflect the interactions among entities developing and marketing future products and users or consumers of these products as well as interactions with entities developing new technology that may support development of future products. The three vertical columns and associated arrows reflect opportunities for interaction among developers, consumers, and interested and affected parties and regulatory agencies throughout the life cycle of a product.
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From page 21... ...
. The developer may initiate preliminary discussions with a regulatory agency and sharing of preliminary data to obtain advice about regulatory paths (arrow between "Product development" and "Premarket support" boxes, Figure 1-2, arrow C)
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Depending on the results of initial studies to support the risk analysis, the regulatory agency and the product developer may determine there is sufficient certainty in the risk analysis to proceed with a regulatory decision or they may conclude that additional information may be needed for the risk analysis (arrow from "Risk analyses" box to "Product submission" box, Figure 1-3, arrow F)
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From page 23... ...
Depending on the operative statute, if the developer wishes to expand the use pattern of the product, it may be required to submit additional data to the appropriate regulatory agency (or agencies) for evaluation.
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In this scenario, if post-market data indicate unanticipated adverse effects associated with the product's use, the appropriate regulatory agency could initiate a risk analysis to determine if risk mitigation is required. Unregulated Products Alternative In this scenario, initial premarket discussions with a product developer may determine that, given the nature of the product, it is not regulated under existing statutes.
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From page 25... ...
2017. Modernizing the Regulatory System for Biotechnology Products: An Update to the Coordinated Framework for the Regulation of Biotechnology.
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