The Food and Drug Administration's Center for Veterinary Medicine (CVM) is conducting a risk assessment of animal cloning as it may affect animal health and the safety of food products derived from animal clones or their progeny.
The specific cloning technique FDA is focusing on is known as somatic cell nuclear transfer (SCNT). "Dolly," a sheep born on July 6, 1996, was produced using this technology. SCNT lends itself to commercial use because it allows the generation of large numbers of animals from a single donor. Often, donor animals are adults whose genetic superiority has already been demonstrated. Although cloning is relatively new, because of its promise, breeders have expressed strong interest in using this technology to improve the quality of their breeding stock.
SCNT involves transferring the genetic information from one animal and inserting it into an oöcyte, or immature egg, that has had its nucleus removed. The resulting embryo is implanted into a surrogate mother, which carries the fetus to birth. Clone progeny have been defined as sexually-reproduced animals one or both of whose parents are clones. The Draft Animal Cloning Risk Assessment applies only to animal clones and their progeny, and does not address animals that have been genetically engineered (“transgenic” animals).
The Draft Animal Cloning Risk Assessment is part of an open scientific process that FDA has undertaken to assess the safety of food products derived from animal clones and their progeny, specifically cattle, pigs, goats, and sheep. It evaluates whether SCNT poses any risks to animals involved in the cloning process, and whether edible products derived from clones or their progeny pose any additional food or feed consumption risks relative to food or feed derived from animals developed by conventional means or other assisted reproductive technologies.
FDA’s process began in late 1999, when FDA commissioned the National Academy of Sciences (NAS) to consider scientific information on animal biotechnology, including clones. The NAS concluded that although food from animal clones posed only a low level of food safety concern, it would be prudent to have more data in order to minimize further safety concerns (NAS/NRC 2002). Therefore, FDA decided to conduct a risk assessment of all of the data available on clones and their progeny, followed by the development of commensurate risk management options, in an open and transparent process.
FDA released a Draft Executive Summary of its Draft Animal Cloning Risk Assessment in November of 2003 as part of its presentation to the Veterinary Medicine Advisory Committee (VMAC). FDA's VMAC conducted a public, open, and detailed review of the draft risk assessment methodology, summary data, and conclusions for food safety and animal safety. The VMAC review, a peer review process, was a key element in the Agency's effort to ensure that the complex issues facing the Agency regarding animal cloning are evaluated using a process that affords the greatest degree of transparency and scientific rigor. FDA has taken those comments into consideration in its revision of the Draft Animal Cloning Risk Assessment as well as including new data that have become available since the VMAC meeting.
The Draft Animal Cloning Risk Assessment is limited to a consideration of the science-based animal health and food consumption risks. In the document's technology overview chapter, the Draft Animal Cloning Risk Assessment provides context for the use of cloning, by providing an overview of the continuum of assisted reproductive technologies currently used in agriculture. The document includes a general overview of the risk assessment methodology used, and individual chapters address potential health risks to animals involved in the process of cloning and potential food consumption risks that may result from edible products derived from animal clones or their progeny. The data on which the Draft Animal Cloning Risk Assessment is based has been obtained from publications from peer-reviewed journals, one large data set on cattle clones, as well as another on swine clones and their progeny made available by two clone producers (contained in the appendices). All of the information that has been used in the Draft Animal Cloning Risk Assessment becomes publicly available upon the posting of the document, to make this process as transparent as possible.
The Draft Risk Assessment does not include any policy analyses or recommendations about the marketing food from animal clones or their progeny or animal health or other issues. When FDA issues the Draft Risk Assessment for public comment, it also plans to issue a Proposed Risk Management Plan that would describe proposed actions that the agency might take to address animal health issues and food consumption risks identified in the Draft Risk Assessment that are within the agency's purview. This proposed document would also be available for public comment. To the extent FDA has recommendations or policy statements in connection with the Draft Risk Assessment, it would issue those consistent with the requirements of the Good Guidance Practice regulations at 21 CFR 10.115. Such draft guidance would also be subject to public comment.
FORMAL CHARGE
Goal. The goal of this Peer Review is a written report reflecting the independent view of each peer reviewer that will be a thorough and meaningful assessment of the agency’s work product. When an agency generates a scientific assessment, it is presenting its scientific judgment about the accumulated evidence. The Peer Review report should distinguish scientific facts from professional judgments and provide input on the reasonableness of judgments made from the scientific evidence. The result should be an independent determination by each peer reviewer as to the appropriateness of (a) the assumptions made and hypotheses postulated, (b) the methodology utilized, (c) the quality and relevance of the data and information, (d) the accuracy of the analytic results, and (e) whether the conclusions reached are supported.
Specific Technical Questions. Peer Reviewers are charged with providing a broad evaluation of the overall Draft Animal Cloning Risk Assessment. In addition, they are asked to respond to the following Specific Technical Questions:
Has the risk assessment adequately discussed whether cloning introduces any unique risks to either animal health or the consumption of food from clones or their progeny relative to current agricultural practices?
Has the Risk Assessment adequately identified the hazards and characterized the risks relating to animal health?
Has the Risk Assessment adequately identified the hazards and characterized the risks relating to food consumption?
Has the risk assessment adequately addressed whether the edible products derived from animal clones and their progeny are as safe to eat as the edible products derived from their conventional counterparts?
Peer Reviewers are charged with clearly identifying and characterizing any scientific uncertainties and ensuring that the potential implications of the uncertainties for the technical conclusions drawn are clear. Where reviewers identify scientific uncertainties, they are requested to suggest ways to reduce or eliminate those uncertainties and to comment on how the government should address the uncertainties which the Draft Risk Assessment identifies. Peer Reviewers will not consult with each other in the preparation of their independent reports, but will pose any questions to the agency about the Peer Review through the Peer Review Coordinator. The agency will respond to administrative questions and, if the agency decides such an action is necessary, will expand or update this charge.
A description of any additional research that would appreciably influence the conclusions of the assessment would help FDA to assess and target subsequent efforts. A Peer Reviewer can bring to FDA’s attention as part of the Peer Review process any additional relevant studies or other important sources of information that the Peer Reviewer believes were not adequately considered in the Draft Risk Assessment.
The Peer Review Coordinator, one of the three individual peer reviewers, has been designated by FDA as responsible for receiving from individual Peer Reviewers any questions about the Peer Review. The Peer Review Coordinator will assemble the individual reports of peer reviewers, redacting any information from the reports that would associate the individual Peer Reviewers with a specific report or comment, and will transmit the compiled Peer Reviews to the agency. At his or her option, The Peer Review Coordinator may prepare an introductory, transmittal, or concise overarching summary statement for transmission with the Peer Reviews; however, any such statement will represent the individual views of each Peer Reviewer, including any disparate and dissenting views, and will be independently prepared without any consultation among the Peer Reviewers.
Cautionary note: Peer Reviewers are not to provide advice on policy questions, which are solely within the purview of the government.
Transparency. The agency will disclose to the public this charge and the complete Peer Review report, which will include a verbatim, but unsigned, copy of each reviewer's comments and, at the option of the Peer Review Coordinator, an introductory, transmittal, or concise overarching summary statement. The Peer Review Report will also provide no less than a paragraph on both the credentials and relevant experiences of each Peer Reviewer. The agency will disclose to the public the identities and organizational affiliations of the Peer Reviewers. In order to further maintain confidentiality, however, the Peer Review Coordinator will not provide to FDA any association or attribution of identity or organizational affiliations of the individual reviewers with specific reports or comments and the report disclosed to the public will not include any such associations or attributions.
The agency intends to prepare a written response to the Peer Review report explaining (a) the agency's agreement or disagreement with the views expressed in the report, (b) the actions the agency has undertaken or will undertake in response to the report, if any, and (c) the reasons the agency believes those actions, if any, satisfy the key concerns stated in the report, if applicable.
Distribution. FDA intends to disseminate the final Peer Review report on the agency's website along with materials related to the Peer Review, including this charge statement and the agency response to the Peer Review report.
References:
NAS/NRC 2002. Animal Biotechnology: Science-Based Concerns. National Academies Press. Washington, DC. ISBN 0-309-08439-3.
Executive Office of the President Office of Management and Budget Final Information Quality Bulletin for Peer Review. www.whitehouse.gov/omb/inforeg/peer2004/peer_bulletin.pdf
Department of Health and Human Services. Guidelines for Ensuring the Quality of Information Disseminated to the Public. http://aspe.hhs.gov/infoquality/Guidelines/fda.shtml
Food and Drug Administration. Guidance on Ensuring the Quality of Information Disseminated to the Public. http://www.hhs.gov/infoquality/FDA-Oct3.doc
Executive Office of the President Office of Management and Budget. Guidelines for Ensuring and Maximizing the Quality, Objectivity, Utility, and Integrity of Information Disseminated by Federal Agencies. http://www.whitehouse.gov/omb/fedreg/final_information_quality_guidelines.html
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