2017转基因变局：美欧战略诱导成功，开始撤退，中国深陷转基因泥潭。

2017-1-27 17:50| 发布者: 风在手| 查看: 3598| 评论: 21|原作者: 顾秀林|来自: 民间智库论坛

摘要: 美国FDA直接递话筒给王大妈是一种，法国和俄罗斯等国家的话筒，是真正的独立的科学家报告转基因的危害，虽然被疯狂打压，但是人民听见了真科学家的声音。在德国，则是静悄悄的联邦议会立法。德国2016年11月2日通过禁 ...

2017转基因变局：美欧战略诱导成功，开始撤退，中国深陷转基因泥潭

(https://www.whitehouse.gov/sites/default/files/microsites/ostp/modernizing_the_reg_system_for_biotech_products_memo_final.pdf).

Producers of foods from plant varieties developed using genome editing techniques, like all food producers, have an obligation under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) to ensure that the foods they offer consumers are safe and in compliance with applicable legal requirements (57 FR 22984 at 22985), available athttp://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/Biotechnology/ucm096095.htm. The FD&C Act gives FDA broad authority to initiate legal action against a food that is adulterated or misbranded within the meaning of the statute (id.). In 1992, FDA issued a statement of policy (57 FR 22984) that discussed scientific issues and provided guidance relevant to the safety assessment of foods derived from new plant varieties derived by traditional methods, tissue culture methods, and recombinant DNA methods (57 FR 22984 at 22991). The guidance provided in the 1992 policy has helped to ensure that developers of new plant varieties make market entry decisions consistent with the FD&C Act. FDA also explained that we have long regarded it to be a prudent practice for producers of foods using new technologies to work cooperatively with us to ensure that the new products are safe and comply with applicable legal requirements (57 FR 22984 at 22991). Over the past 20 years, developers have routinely consulted FDA about the safety and legality of foods from new genetically engineered plant varieties prior to marketing. These consultations have relied on the objective characteristics of foods to consider their safety and legality prior to marketing. This process has worked well and has helped developers ensure that all safety and other legal issues are satisfactorily addressed prior to market entry of foods derived from these new varieties. FDA intends to continue offering consultations for developers of new plant varieties, including those produced using genome editing, in order to help developers ensure that applicable safety and legal questions are resolved prior to market. In addition to the information we anticipate gathering from developers in the course of consultations, we recognize that developers, researchers, and other stakeholders may have valuable factual information and data about foods derived from new plant varieties produced using genome editing, which can help inform FDA's thinking for these specific products. Therefore, we invite comment in this notice.

II. Additional Issues for Consideration and Invitation for Comment: Genome Editing in Plants

To help inform our thinking on foods derived from new plant varieties produced using genome editing, we invite comment on the following questions:

1. In what ways are the food safety risks associated with human and animal foods from genome edited plants the same as or different from those associated with other plant development methods (e.g., hybridization, chemical or radiation-induced mutagenesis and non-targeted genetic modifications using in vitro recombinant DNA technologies)? Please provide data and/or information to support your view.

· To what extent is the scientific knowledge of and experience with current new plant varieties (such as those developed with in vitro recombinant DNA technologies that have gone through the voluntary consultation process) relevant to the safety assessment and regulatory status of food from new plant varieties produced using genome editing? Is there additional scientific knowledge that would be relevant specifically to the safety assessment and regulatory status of new plant varieties produced using genome editing? Please provide data and/or information to support your view.Start Printed Page 6566

2. Are there categories of genome edited plant varieties for which there are scientific bases to conclude that foods from such categories are unlikely to present food safety risks different from or greater than those for traditional plant breeding? Similarly, are there categories of genome edited plant varieties for which the regulatory status of the food derived from such plant varieties can be said to be no different from that of traditionally-bred plants? If there are such categories, is there a basis upon which to determine that there would be no reason to include them in any voluntary premarket consultation process? If so, please describe the characteristics of such categories (including, for example, information about the types of phenotypes and modifications (insertions, deletions or substitutions) achieved through genome editing) and provide data and/or information for why plant varieties in these categories are unlikely to present food safety risks or regulatory status questions. Regulatory status questions may include, for example, whether food from the new plant variety contains an unapproved food or color additive such that premarket review and approval is required (see sections 409 and 721 of the FD&C Act). As another example, if food from the new plant variety has a different nutritional profile from food from traditionally-bred plants, then certain labeling may be required to disclose a material change in the food.

a. If such categories exist, how do plant developers ensure the safety of foods from new plant varieties in these categories? For example, how are safety assessments of foods from these varieties accomplished, and what data and information are or should be considered in such assessments?

b. If certain categories of genome edited plants do not raise questions of safety or regulatory status, should there nevertheless be a mechanism separate from the voluntary premarket consultation process through which plant developers may voluntarily notify FDA about their intent to market a food derived from a genome edited new plant variety that falls within these categories? If so, what process should plant developers use to notify FDA? What kind of information should be included in such a notification to FDA?

c. Given that genome editing techniques can give rise to a broad range of plant modifications, from simple gene deletions to totally novel genes, and that some such modifications can be achieved through traditional breeding, please discuss the basis upon which to determine that there would or would not be a reason to include, in any voluntary premarket consultation process, foods from genome edited crops with modifications that could have been achieved through traditional breeding.

3. Are there categories of genome edited plant varieties for which there are scientific bases to conclude that foods from these categories are more likely than traditionally-bred plants to present food safety risks? If so, please describe the characteristics of these categories (including, for example, information about the types of phenotypes and modifications (insertions, deletions or substitutions) achieved through genome editing) and provide data and/or information to support why plant varieties in these categories are more likely to present food safety risks than traditionally-bred plants.

4. What steps can we take to help small firms, including those who may be considering using genome editing to produce new plant varieties for use in human or animal food, to engage with FDA about any questions related to food safety or the regulatory status of foods from their new plant varieties? Please provide supporting data and other information to support your comments and responses to this question.

Dated: January 11, 2017.

Leslie Kux,

Associate Commissioner for Policy.

Footnotes

1. https://www.whitehouse.gov/sites/default/files/microsites/ostp/biotech_national_strategy_final.pdf.

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[FR Doc. 2017-00840 Filed 1-18-17; 8:45 am]

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