本文同时发至北京海淀法院。
http://zhiyanle.blog.hexun.com/95733213_d.html .
农官院士李宁借转基因动物作物研究之名而非法移用国家资金而归为个人私有,被带走接受调查。那不过是农业系统推销转基因而营私舞弊的冰山一角。就此案情,和讯博客首页数日挂了方舟子的文章,用谎言为李宁的腐败行为辩护、继续对社会搞欺骗。因此,崔永元说方舟子是“骗子”,符合事实。
方舟子的欺骗言论:李宁院士研究的转基因动物实质是通过转基因技术让牛奶中含有某种生物制剂(乳铁蛋白),这在美国早就实现产业化了:2009年2月6日FDA正式批准了第一种由转基因动物生产的生物制剂——转基因山羊奶生产的人抗凝血酶。……对转基因作物则采取“自愿咨询”,无需审批即可上市。
事实:已经有读者指明,李宁搞的是食品而不是药品(见中国国家标准GB14880-2012)。
事实:FDA批准的抗凝血酶是药品(Atryn)而不是食品、且明确说明不得进入食品供应链,见:
FDA Approves First Human Biologic Produced by GE Animals。
Page Last Updated: 05/09/2013 。
URL:http://www.fda.gov/AnimalVeterinary/NewsEvents/FDAVeterinarianNewsletter/ucm190728.htm 。
该新闻公告说的很明白,但我还是询问了FDA。该部门负责相关领域的法规政策之官员爱泼斯坦等做了回答,如下:
我的问题:获知2009年FDA批准了首个用来生产药品的转基因动物。我能否购买该转基因动物并用它们来为我的顾客而生产药品?
FDA官员回答:……that the (GE)goats that produce Atryn are used solely by one particular sponsor at a single location. The Atryn produced by these goats is sold commercially but the goats themselves are not sold.”。还说:“As we previously said, you cannot purchase the Atryn goats to produce medicine.”(大意:批准的转基因动物仅仅为一个特定开发者在一个地点生产该药品。你不能购置那些转基因动物来生产药品。)。
我进一步问:如此说来,该转基因动物的批准是有限或特定用途的批准、没有批准该转基因动物商业化上市,我的理解对吗?是否所有的用来生产药品的转基因动物或转基因植物都有同样的法规政策?
FDA官员回答:Yes, you are correct. Each GE animal is regulated under a separate application. GE plants that produce drugs are regulated under a different regulatory scheme. (大意:是的,你的理解正确。每个转基因动物按其不同应用而区别管理。用来制造药品的转基因植物之管理有不同的规定。)。
很清楚,FDA批准的该转基因动物只能是一个特定厂商在一个特定地点生产获得批准的特定药品,没有批准该转基因动物商业化上市。
事实:关于转基因食品,FDA明文规定要求上市前须经FDA审核。相关公文挺多,其中有:
[1] 关于转基因植物之食品或饲料:
Biotechnology: Genetically Engineered Plants for Food & Feed 。Page Last Updated: 09/12/2014 。
URL:http://www.fda.gov/Food/FoodScienceResearch/Biotechnology/ 。
FDA's Biotechnology Policy。
……In the Federal Register of January 18, 2001 (the pre-market notification proposal; 66 FR 4706, available as text and 193 KBPDF), FDA issued a proposed rule that would require that developers submit a scientific and regulatory assessment of the bioengineered food 120 days before the bioengineered food is marketed。
[2] 关于转基因动物食品:
Consumer Q&A,Page Last Updated: 06/10/2014.
URL:http://www.fda.gov/AnimalVeterinary/DevelopmentApprovalProcess/GeneticEngineering/GeneticallyEngineeredAnimals/ucm113672.htm 。
……It would be illegal to introduce food from an unapproved GE animal into the food supply without FDA permission. We work closely with GE animal producers to make sure that they keep good records of their animals and that none enter the food supply without FDA approval.
[3] 关于转基因食品添加剂:
Premarket Notice Concerning Bioengineered Foods。FDA,Federal Register Volume 66, Number 12 (Thursday, January 18, 2001)]
……If the protein sweetener is a food additive, pre-market approval of the substance would be required under section 409 of the act before the altered food could be lawfully marketed.
那些公文都清楚说明,转基因食品产品上市前必须经过FDA审核;即:方舟子的所谓转基因食品“无需审批即可上市”是造谣欺骗。
事实:如何理解FDA规定中的“自愿”之类的言辞呢?本人前文已经说了,这里再重复:那是遵循美国宪法规定,即官方行政机构及其官员无权强迫公民接受其政策法规;然而,若某公民违犯相关政策法规,那么,该部门有充分权力通过司法部门来迫使该公民服从法规。
举个“典型”例子。美国宪法条款:“Amendment V: Persons accused of serious crimes have the right to a jury trial. They may not be forced to give evidence against themselves.”(大意:不得强迫被指控为犯罪的公民提供对其不利的证据。)。对被指控为犯罪嫌疑的公民如此,可见,对没有被指控的公民、就更不能实行强迫。然而,若那些公民不遵守相关法规,那么,主管部门就有充分权力通过执法部门(譬如警察或刑警)来依法管制(包括强迫性管制)。
在“自愿”等措辞方面,方舟子也搞了造谣欺骗。
简而言之,崔永元说方舟子是“骗子”,符合事实且有不少案例,这里又是一个案例。
参考阅读:方舟子骗了法庭、又骗社会。2014-08-22 12:19:14。
http://zhiyanle.blog.hexun.com/95179403_d.html 。
附件:本人询问和FDA官员答复(原文摘录。即时问答、某些文字有可修改之处,不赘。):
我的问题(September 01, 2014 10:51 PM):
As Atryn is approved by FDA, does it mean that the GE animals (GE goats) are also approved?
As Atryn can be marketed (for medicine purposes), can the GE animal (GE goats) be commercialized and marketed or not?
FDA官员答复(Fri 9/05/14 4:58 AM):
You are correct that the goats that produce Atryn are FDA-approved.
We note, however, that the goats that produce Atryn are used solely by one particular sponsor at a single location. The Atryn produced by these goats is sold commercially but the goats themselves are not sold.
我的问题(September 12, 2014 4:17 PM):
May I understand it as: FDA approved those GE goats for limited/targeted commercial use but not for marketing. In such case, my questions are:
[1] If I purchase those GE goats (GE animals) and use them to produce medicines for my market,
[2] If I purchase breeds of those FDA-approved GE goats and use them to grow my own GE animals,
what should I do regarding FDA regulations/policies?
FDA官员答复(Fri 9/19/14 5:35 AM):
As we previously said, you cannot purchase the Atryn goats to produce medicine.
我的问题(Sun 9/21/14 5:59 PM):
[1] FDA approved GE goats (re: Atryn) for limited/targeted commercial use but not for marketing. Thus, I cannot purchase the GE goats. Am I correct?
[2] Does FDA have the same policies/regulations for all GE animals and for all GE plants re medicine purposes?
FDA官员答复(Sun 9/21/14 8:14 PM):
1) Yes, you are correct.
2) Each GE animal is regulated under a separate application. GE plants that produce drugs are regulated under a different regulatory scheme.
#-#-#。
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