Synthetic Biology: Does Re-Writing Nature Require Re-Writing Regulation?

Paradise, Jordan; Fitzpatrick, Ethan R

doi:10.2139/ssrn.1975054

Cited by 4 publications

(3 citation statements)

References 14 publications

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“…155 As asserted by Paradise and Fitzpatrick, regulatory mechanisms should be, first, strengthened to consider the specific characteristics of innovative products and, second, should address novel aspects, as well as other considerations. 156 Such an 'opt-out' clause would allow member states to base their decision on non-scientific grounds and would introduce some flexibility in the regime.…”

Section: The 2013 Novel Foods Proposalmentioning

confidence: 99%

Frankenburgers, Risks and Approval

Petetin¹

2014

Eur. j. risk regul.

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This piece critically analyses the development of a novel food technology: the Frankenburger, a type of cultured/in vitro meat (or ‘shmeat’, which stands for ‘sheet of meat’). It assesses the risks raised by cultured meat as well as the role it could play to alleviate environmental and food security concerns. The article argues that the current EU regulatory structures for cultured meat, and for novel foods more generally, ought to be strengthened. There is a necessity to transfer and develop food innovations in partnerships with all the relevant stakeholders (the public, scientists, the food industry, policy-makers and regulators). Including interested parties from the inception of a technology as well as within the decision-making process would provide a supporting framework for cultured meat.

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Section: The 2013 Novel Foods Proposalmentioning

confidence: 99%

Frankenburgers, Risks and Approval

Petetin¹

2014

Eur. j. risk regul.

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“…The byproducts are diluted after metabolism in the human system before being discharged into the environment with hardly any risk. 66 An organism consumed as a drug is not digested but survives in the human body. Preventing its escape into the environment or tracing it, upon escape, would be problematic.…”

Section: Risks From Microbial Drugsmentioning

confidence: 99%

Synthetic Biology and Biosafety Governance in the European Union and the United States

Akpoviri

Zainol

Baharum

2020

IIUMLJ

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This article examines how synthetic biology, which is the construction of novel biological parts, devices, and systems, as well as the modification of regular organisms, impacts biosafety regimes in the European Union (EU) and the United States (US). The article examines the nature and benefits of synthetic biology. It then reviews associated biosafety challenges, before analysing the suitability of governance frameworks in the EU and the US in dealing with these challenges. Based on this analysis, the article contends that, despite some similarities with older technologies, synthetic biology is essentially novel. Consequently, it undermines existing biosafety regimes in both jurisdictions. The article advocates for effective governance, combining formal regulation and self-governance, in addition to the global coordination of governance measures. This will help maintain an agile policy and curtail any regulatory loopholes. This article fosters awareness on the existence of many unresolved controversies over the synthetic biology technology.

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“…A consistent theme running throughout the regulatory construct is that governance under the FFDCA largely turns on the concept of a statutorily defined ''product'' rather than a defined manufacturing process of which the product of concern is an endpoint. 2 Any regulatory approach driven by statutorily defined ''products'' necessarily makes it less than nimble in the context of fast changing innovations in the area of industrial biotechnology. Both the inflexibly defined products and the separate FDA ''Centers'' that regulate them contribute to a balkanization of the review process.…”

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confidence: 99%

Industrial Biotechnology: Coordinated Framework Make-Over and Lots More

BergesonLynn¹

2015

Industrial Biotechnology

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he summer of 2015 was surprisingly busy in the industrial biotechnology policy and regulatory arenas with three important announcements generating lots of buzz. On July 2, 2015, the White House Office of Science and Technology Policy (OSTP), the Office of Management and Budget (OMB), the US Trade Representative, and the Council on Environmental Quality issued a memorandum directing the US Environmental Protection Agency (EPA), the US Food and Drug Administration (FDA), and the US Department of Agriculture (USDA) to update and modernize the Coordinated Framework for the Regulation of Biotechnology (Coordinated Framework). A few weeks later, EPA's Office of Pollution Prevention and Toxics (OPPT) announced a project intended to support public dialog concerning the development and use of biotechnology by developing a new algae ''how to'' document for Toxic Substances Control Act (TSCA) purposes, and to help jump start much needed public discourse around the topic of biotechnology in general. Finally, OPPT also announced that it is updating its Points to Consider in the Preparation of TSCA Biotechnology Submissions for Microorganisms (Points to Consider). Each of these developments is important. This article discusses these initiatives, offers insights on why stakeholders should applaud these opportunities, and urges stakeholders to seize the moment and to engage vigorously in them. Engagement will ensure that the government and other interested parties, including the public, are fully informed about these emerging technologies and their importance to society, and are confident in the government's oversight of them. Coordinated Framework for Regulation of Biotechnology Federal oversight of products of biotechnology is directed through the Coordinated Framework issued in 1986 by the Reagan Administration's White House OSTP, and updated in 1992. 1 The core premise of the Coordinated Framework is that the legal authorities that existed in 1986, statutory authorities that remain largely unchanged today, provide federal regulators sufficient authority to manage any health and/or environmental risk that products of biotechnology may pose. Recognizing that many federal agencies have jurisdiction over products of biotechnology , the Coordinated Framework sets forth an organizational blueprint for federal agency oversight and establishes lead responsibilities for the federal oversight of products of biotechnology. The Coordinated Framework was intended to be a flexible governance construct capable of nimbly adjusting to new science and innovation, and not shackle the oversight of new products to inflexible regulatory templates. Risks are assessed on a case-by-case, product-by-product basis, and federal oversight focuses on a product's application and its intended use, not on the technology itself. Under the Coordinated Framework, three federal agencies are principally responsible for regulating products of biotechnology: USDA, and in particular its Animal and Plant Health Inspection Service (APHIS), EPA, and FDA. APHIS is resp...

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Synthetic Biology: Does Re-Writing Nature Require Re-Writing Regulation?

Cited by 4 publications

References 14 publications

Frankenburgers, Risks and Approval

Frankenburgers, Risks and Approval

Synthetic Biology and Biosafety Governance in the European Union and the United States

Industrial Biotechnology: Coordinated Framework Make-Over and Lots More

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