本文同時發至北京海淀法院。

　　http://zhiyanle.blog.hexun.com/95733213_d.html .

　　農官院士李寧借轉基因動物作物研究之名而非法移用國家資金而歸為個人私有，被帶走接受調查。那不過是農業系統推銷轉基因而營私舞弊的冰山一角。就此案情，和訊博客首頁數日掛了方舟子的文章，用謊言為李寧的腐敗行為辯護、繼續對社會搞欺騙。因此，崔永元說方舟子是“騙子”，符合事實。

　　方舟子的欺騙言論：李寧院士研究的轉基因動物實質是通過轉基因技術讓牛奶中含有某種生物制劑(乳鐵蛋白)，這在美國早就實現產業化了：2009年2月6日FDA正式批準了第一種由轉基因動物生產的生物制劑——轉基因山羊奶生產的人抗凝血酶。……對轉基因作物則采取“自愿咨詢”，無需審批即可上市。

　　事實：已經有讀者指明，李寧搞的是食品而不是藥品(見中國國家標準GB14880-2012)。

　　事實：FDA批準的抗凝血酶是藥品(Atryn)而不是食品、且明確說明不得進入食品供應鏈，見：

　　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 。

　　該新聞公告說的很明白，但我還是詢問了FDA。該部門負責相關領域的法規政策之官員愛潑斯坦等做了回答，如下：

　　我的問題：獲知2009年FDA批準了首個用來生產藥品的轉基因動物。我能否購買該轉基因動物并用它們來為我的顧客而生產藥品?

　　FDA官員回答：……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.”。還說：“As we previously said, you cannot purchase the Atryn goats to produce medicine.”(大意：批準的轉基因動物僅僅為一個特定開發者在一個地點生產該藥品。你不能購置那些轉基因動物來生產藥品。)。

　　我進一步問：如此說來，該轉基因動物的批準是有限或特定用途的批準、沒有批準該轉基因動物商業化上市，我的理解對嗎?是否所有的用來生產藥品的轉基因動物或轉基因植物都有同樣的法規政策?

　　FDA官員回答：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，你的理解正確。每個轉基因動物按其不同應用而區別管理。用來制造藥品的轉基因植物之管理有不同的規定。)。

　　很清楚，FDA批準的該轉基因動物只能是一個特定廠商在一個特定地點生產獲得批準的特定藥品，沒有批準該轉基因動物商業化上市。

　　事實：關于轉基因食品，FDA明文規定要求上市前須經FDA審核。相關公文挺多，其中有：

　　[1] 關于轉基因植物之食品或飼料：

　　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] 關于轉基因動物食品：

　　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] 關于轉基因食品添加劑：

　　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.

　　那些公文都清楚說明，轉基因食品產品上市前必須經過FDA審核;即：方舟子的所謂轉基因食品“無需審批即可上市”是造謠欺騙。

　　事實：如何理解FDA規定中的“自愿”之類的言辭呢?本人前文已經說了，這里再重復：那是遵循美國憲法規定，即官方行政機構及其官員無權強迫公民接受其政策法規;然而，若某公民違犯相關政策法規，那么，該部門有充分權力通過司法部門來迫使該公民服從法規。

　　舉個“典型”例子。美國憲法條款：“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：不得強迫被指控為犯罪的公民提供對其不利的證據。)。對被指控為犯罪嫌疑的公民如此，可見，對沒有被指控的公民、就更不能實行強迫。然而，若那些公民不遵守相關法規，那么，主管部門就有充分權力通過執法部門(譬如警察或刑警)來依法管制(包括強迫性管制)。

　　在“自愿”等措辭方面，方舟子也搞了造謠欺騙。

　　簡而言之，崔永元說方舟子是“騙子”，符合事實且有不少案例，這里又是一個案例。

　　參考閱讀：方舟子騙了法庭、又騙社會。2014-08-22 12:19:14。

　　http://zhiyanle.blog.hexun.com/95179403_d.html 。

　　附件：本人詢問和FDA官員答復(原文摘錄。即時問答、某些文字有可修改之處，不贅。)：

　　我的問題(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官員答復(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.

　　我的問題(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官員答復(Fri 9/19/14 5:35 AM)：

　　As we previously said, you cannot purchase the Atryn goats to produce medicine.

　　我的問題(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官員答復(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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