2008年9月20日土曜日

FDA 遺伝子組換え生物の規制指針案

FDAが遺伝子組換え生物の規制指針案を公表し、意見を求めた。
多くの国では遺伝子操作した食物は国の機関による承認が必要となっている。
しかし、指針案では承認しないものもあるようだ。

遺伝子組み換えした生物はちょっと調べただけでも見つかる。
・抗プリオン牛
・乳腺を発達させたヤギ
・大西洋で育つサケ
・チーズ発酵を促進させる微生物
・オメガ3脂肪酸を高濃度で含む豚
・抗鳥インフルエンザ鶏

究極の食品、製薬等の製造の効率化のために遺伝子操作をするようだが、
現状でも、牛肉はクローン化が行われ、流通している。
遺伝子工学と生産工場が共謀した結果だろう。
再生は歓迎だが、組み換えは嫌だ。


---Farmers back GM animals study---
20th September 2008, 6:00 WST
http://www.thewest.com.au/default.aspx?MenuID=2&ContentID=98746

Australian farmers have urged authorities to consider the use of genetically modified animals for meat, milk and fish after US authorities this week unveiled guidelines to regulate the controversial technology.

The US Food and Drug Administration has released a legal framework to regulate foods which originate from genetically modified animals in an effort to address concerns about the products.

FDA deputy commissioner for Policy Randall Lutter said genetically engineered animals held “great promise” for improving human medicine, agriculture and the production of new materials.

Yesterday, Sheep Meat Council of Australia president Chris Groves said while the practical application of the technology for livestock was “a long way off”, it would be rash to disregard the technology because of ill-founded fears. He said any decisions on GM foods needed to be based on “sound science, not on somebody’s scare campaign”.

“Industry will look at it and assess it on its merits,” he said.

Cattle Council of Australia policy director Jed Matz said there were potential benefits from gene technology for farmers but they needed to be weighed against the perceived risks. “We would like to ensure that there is informed debate,” he said.

Greenpeace campaigner Louise Sales said consumer concerns remained about gene technology, not only over the safety of the product but also the impact on the livestock involved. She said higher mortalities in offspring of GM livestock had been recorded in some cases.

“There is a serious ethical question of is it worth animals dying to improve the protein quantity in milk, for example,” she said.

GM food which comes on the market must be approved by Food Standards Australia and New Zealand. A spokeswoman said various plantbased GM products had been approved, but there had been no application for an animal-derived GM product.

A number of trials involving GM animals are under way in Australia, including a CSIRO pilot project into transgenic chickens which are resistant to avian influenza. All trials must be approved by the Gene Technology Regulator. A spokeswoman from the Office of the GTR said no licences had been issued for the environmental release of GM animals.

University of WA animal biologist Philip Vercoe said there was interest in GM technology to improve food production, either through increased yields or better quality. Interest areas ranged from improving milking capacity of cows to healthier fats in red meat. Other interest in the technology was for producing transgenic animals for the production of pharmaceutical drugs, called “pharming”.

JODIE THOMSON

---米、遺伝子改変動物の指針案公表 産業利用で---
2008年9月19日 10時26分
http://www.tokyo-np.co.jp/s/article/2008091901000217.html

 【ワシントン18日共同】成長を促進したり薬を分泌したりする遺伝子を組み込んだ遺伝子改変動物の産業利用の機運が高まっているとして、米食品医薬品局(FDA)は18日、規制の指針案を公表し、60日間の意見募集を開始した。
 遺伝子を改変した生物は、微生物や植物に関しては環境に影響を与えないなどの歯止めをかけた上で広く産業利用されているが、動物については研究目的以外は特に規制はなかった。
 指針案によると、組み込む遺伝子は新薬と同様に扱い、動物の健康に悪影響を与えないことを原則とする。また、遺伝子の構造や作用をFDAに届け出る。
 遺伝子改変動物を食品として流通させる場合は、安全性の証明とFDAの許可が必要。「遺伝子改変」の表示は必要ないが「遺伝子改変でない」との表示は可能とした。
 消費者団体などは指針案について「安全性評価の中身は秘密で、食品としての利用には懸念がある」と反発している。


---FDA Plans Rules for Modified Food Animals---
* SEPTEMBER 19, 2008
http://online.wsj.com/article/SB122178225360954589.html?mod=googlenews_wsj

WASHINGTON -- The Food and Drug Administration released proposed guidelines on how to regulate genetically engineered animals, in a move that is expected to pave the way for them to enter the food supply.

The biotech industry has long sought to use such technology on fish, pigs, cattle and other animals to produce ones that grow faster or possess desirable traits, such as high fiber content or resistance to illnesses such as mad-cow disease.

According to BIO, a biotechnology trade group, there could be as many as two dozen applications to sell genetically engineered animals already pending before the FDA. One submitted by a Massachusetts developer is for an Atlantic salmon.

Under the proposal, the FDA would require regulatory approval before any genetically engineered animals could be sold as food. The FDA would seek to ensure that any genetic modification was safe for the animal, did what the producer claims, and didn't pose any risk for human consumption. Regulators said they won't require human trials to test the safety of eating genetically modified animals.

"This is a cutting-edge technology that has significant implications, including real benefits, not just for human health, but also for animal health, such as developing disease-resistant animals," said Bernadette Dunham, director of the agency's Center for Veterinary Medicine.

The public has 60 days to comment on the proposal.

Genetically engineered animals are created by inserting a desired gene into the DNA of an animal, or otherwise manipulating relevant genes, to add new traits. The technology is already used in other areas, such as the production of insulin and the development of pest-resistant crops. The food industry uses some genetically engineered microorganisms to aid in baking, brewing and cheese making.

The FDA said it isn't planning to require food makers to notify consumers if products contain ingredients from genetically engineered animals or their offspring. Companies would be required to tell consumers about any changes in food composition, such as when pork from genetically engineered pigs contains higher level of the heart-healthy omega-3 fatty acids.

The biotech industry, which has worked with the FDA for a decade on the issue, welcomed the proposed guidelines. Barbara Glenn, managing director of animal biotechnology at BIO, said the "extremely strict" approval process will help boost consumer confidence and standardize the process. "We hope this spurs the approval of the first product in the United States," she said.

Consumer groups said the guidelines don't go far enough to address possible safety, environmental or other risks, such as if an animal escapes and breeds with nonmodified animals.

"This is a first step for the federal government, but the new guidelines won't address all the problems it poses," said Gregory Jaffe, biotechnology director at the Center for Science in the Public Interest, a consumer group in Washington.

Jaydee Hanson, policy analyst at the Center for Food Safety, another consumer group, said he is worried that, as with drug trials, consumers may be kept in the dark until a food animal is approved. He suggested that at least in the first cases, the FDA should subject the applications to peer review. He also took issue with the agency's plan not to require special labeling on food with ingredients from genetically engineered animals.

FDA officials said they will review each application, hold advisory-committee meetings and monitor the new food animals for safety after they are approved.

The FDA expects to waive premarket approval for certain animals used in research, or not as food, such as it did with a genetically engineered fish that glows in the dark. Officials said they intend to regulate separately such animals used to produce drugs for humans or animals.


---Genetically Engineered Animals---
http://www.fda.gov/consumer/updates/ge_animals_diagram091808.html

New traits can be introduced into animals. Here's how it works for animals engineered to produce a human pharmaceutical.
1. Generation of the DNA Construct
A. Milk Protein Promoter DNA: allows for expression only in goat mammary glands.
B. Therapeutic Protein Gene: encodes a protein known to treat disease in people.
C. Terminator Sequence: assures that only the gene of interest is controlled by A.
D. Other DNA Sequences: helps with the introduction of the new combination DNA strand.
2. The DNA construct is created by combining A, B, C and D.
3. This new DNA strand is then introduced by any of a number of methods into an animal cell, such as an egg, that is then used to produce a genetically engineered animal.
4. The first genetically engineered goat is produced.
5. The offspring of the first genetically engineered goats, referred to as production animals, are milked. The milk is transferred to a purification facility.
6. The drug to be used to treat human disease is purified from the goat's milk.


---FDA Releases Draft Guidance on Regulation of Genetically Engineered Animals---
http://www.fda.gov/consumer/updates/ge_animals091808.html

The Food and Drug Administration (FDA) is inviting the public to comment on draft guidance that discusses FDA's approach to regulating genetically engineered (GE) animals.

Although the guidance, released Sept. 18, 2008, is aimed at industry, FDA believes it may also help the public gain a better understanding of this important and developing area. The guidance explains the process by which FDA is regulating GE animals.
Genetic Engineering

Genetic engineering is a process in which scientists use recombinant DNA (rDNA) technology to introduce desirable traits into an organism. DNA is the chemical inside the nucleus of a cell that carries the genetic instructions for making living organisms. Scientists use rDNA techniques to manipulate DNA molecules.

Genetic engineering involves producing and introducing a piece of DNA (the rDNA construct) into an organism so new or changed traits can be given to that organism. The rDNA construct can either come from another existing organism, or be synthesized in a laboratory. Although conventional breeding methods have been used for a long time to select for desirable traits in animals, genetic engineering is a much more targeted and powerful method of actually introducing specific desirable traits into animals.

Genetic engineering is not a new technology. It has been widely used in agriculture, for example, to make crops like corn and soy resistant to pests or tolerant to herbicides. In medicine, genetic engineering is used to develop microbes that can produce pharmaceuticals. And in food, genetic engineering is used to produce enzymes that aid in baking, brewing, and cheese making.

Benefits of GE Animals

GE animals hold great promise for human and animal health, the environment, and agriculture.

* Health protection of animals – Animals are under development to be more resistant to very painful and harmful diseases, such as infection of the udder (mastitis) in dairy cows and bovine spongiform encephalopathy (widely referred to as "mad cow" disease) in all cattle.
* New source of medicines – Animals can be engineered to produce particular substances, such as human antibodies, to make infection-fighting drugs for people. These "biopharm" animals can change the way we treat chronic diseases, such as bleeding disorders, by providing large quantities of safe, health-restoring proteins that previously were available only from human cadavers.
* Transplantation – Pigs are being engineered so that their cells, tissues, or organs could be transplanted into humans with a reduced risk of immune rejection.
* Less environmental impact – Food animals are being engineered to grow more quickly, require less feed, or leave behind less environmentally damaging waste.
* Healthier food – Food animals, such as pigs, are under development to contain increased levels of omega-3 fatty acids, providing a more healthful product. Livestock can also be engineered to provide leaner meat or more milk.

GE Animals Regulated Under New Animal Drug Provisions

FDA regulates GE animals under the new animal drug provisions of the law, and the agency must approve them before they are allowed on the market. Food and animal feed from GE animals will undergo FDA review before the food or feed can be marketed. The Federal Food, Drug, and Cosmetic Act defines a drug as "an article (other than food) intended to affect the structure or any function of the body of man or other animals." Therefore, the rDNA construct intended to change the structure or function of the body of the GE animal is a drug.

FDA may exercise "enforcement discretion" over some GE animals, based on their potential risk and on a case-by-case basis. This means that the agency may not require premarket approval for a low-risk animal. For example, the agency is not requiring premarket approval for GE lab animals used for research, and did not require approval of a GE aquarium fish that glows in the dark. FDA does not expect to exercise enforcement discretion for animal species traditionally consumed as food.

This guidance will help industry comply with FDA's requirements and will help the public understand FDA's oversight of GE animals and food from such animals.

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