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
Electronic Submissions Submit electronic comments in the following way:
· Federal eRulemaking Portal:https://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, tohttps://www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted onhttps://www.regulations.gov.
· If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”). Written/Paper Submissions
Submit written/paper submissions as follows:
· Mail/Hand delivery/Courier (for written/paper submissions): Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
· For written/paper comments submitted to the Division of Dockets Management, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”
Instructions: All submissions received must include the Docket No. FDA-2016-N-4389 for “Genome Editing in New Plant Varieties Used For Foods; Request for Comments.” Received comments will be placed in the docket and, except for those submitted as “Confidential Submissions,” publicly viewable at https://www.regulations.gov or at the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.
· Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” We will review this copy, including the claimed confidential information, in our consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on https://www.regulations.gov. Submit both copies to the Division of Dockets Management. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as “confidential.” Any information marked as “confidential” will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA's posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at:http://www.fda.gov/regulatoryinformation/dockets/default.htm.
Docket: For access to the docket to read background documents or the electronic and written/paper comments Start Printed Page 6565received, go to https://www.regulations.govand insert the docket number, found in brackets in the heading of this document, into the “Search” box and follow the prompts and/or go to the Division of Dockets Management, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT:
Regarding human food issues: Jason Dietz, Center for Food Safety and Applied Nutrition (HFS-205), Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-2282. Regarding animal food issues: Kathleen Jones, Center for Veterinary Medicine (HFV-220), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 240-402-5938. SUPPLEMENTARY INFORMATION:I. BackgroundUse of Genome Editing Techniques To Produce New Plant Varieties Used for Human or Animal Food
Recently, new technologies have emerged that are intended to alter the genomes of various organisms, including plants. FDA is aware that these technologies make it easier for plant developers to produce new plant varieties with targeted genetic modifications. Using deoxyribonucleic acid (DNA) sequence information from a plant, plant breeders can make targeted changes to a plant's DNA sequence to alter expression of traits in the plant. These new methods include processes using targeted nucleases (clustered regulatory interspersed short palindromic repeat associated nucleases, zinc-finger nucleases, meganucleases, and transcription activator-like effector nucleases or targeted oligonucleotides (oligonucleotide-directed mutagenesis) intended to modify a plant's DNA sequence by insertion, deletion, or substitution of nucleotides at a specific site in a plant's genome. The process of producing these targeted DNA sequence alterations is often referred to as “genome editing.”
In the National Strategy for Modernizing the Regulatory System for Biotechnology Products (theStrategy; released by the White House Office of Science and Technology Policy on September 16, 2016),[1] FDA noted its intent to clarify its policy for the regulation of products derived from genome editing techniques, including, as appropriate, identifying and/or updating relevant existing guidance documents. Consistent with this commitment in the Strategy document, FDA is opening this docket to inform its thinking on foods derived from plants produced using genome editing techniques. FDA also looks forward to receiving the results from the study being conducted by the National Academies of Sciences, Engineering, and Medicine entitled “Future Biotechnology Products and Opportunities to Enhance Capabilities of the Biotechnology Regulatory System” commissioned under the Update to the Coordinated Framework for Regulation of Biotechnology, available at http://nas-sites.org/biotech/. As we consider this issue, we intend for our actions to be guided by the principles for the regulation of biotechnology products articulated in the 2017 Update to the Coordinated Framework (https://www.whitehouse.gov/sites/default/files/microsites/ostp/2017_coordinated_framework_update.pdf) and the goals and objectives of the July 2015 EOP memorandum |
手机版|小黑屋|Archiver|中国琉球网 ( 闽ICP备13003013号 )
GMT+8, 2025-1-15 15:19 , Processed in 1.609783 second(s), 11 queries , File On.
Powered by Discuz! X3.4
© 2001-2023 Discuz! Team.