FDA Proposes Guidelines For Genetically Engineered Animals

The U.S. Food and Drug Administration (FDA) released proposed guidelines for how it would regulate genetically engineered (GE) animals to ensure that they are safe for humans and the environment.

 

Scientists produce GE animals by combining genes from different organisms to enhance their traits. Although GE animals have been produced and studied in laboratories for many years, meat from GE animals is not available for consumption in the United States. The FDA's proposed guidelines focus on animals that would be used as foods or whose blood or milk would be used to make medications.

The FDA plans to work with agencies in the U.S. Department of Agriculture (USDA) and other federal departments and agencies, such as the Environmental Protection Agency (EPA) to regulate the industry and develop coherent policies.

 

According to the guidelines, producers of GE animals that are intended for food use will need to prove to that their products are safe to eat. The FDA also plans to assess any potential environmental impacts of GE animals.

 

The FDA does not plan to require GE animal products to bear labels indicating that they are genetically modified. Similarly, foods from GE plants dos not have to be labeled. However, labeling may be required if the GE animal if different from its non-engineered counterpart, for instance, if there was a change in its nutritional profile.

 

Although GE animal products are not on the market yet, GE produce has been sold for many years. According to the FDA and USDA, there are more than 40 genetically modified plants that have completed all of the federal requirements to be sold in the United States. Genetic engineering is commonly used in agriculture to improve resistance to diseases, pests and herbicides. It has also been used to improve taste and quality, reduce maturation time, increase nutrition and increase tolerance to extreme temperatures.

The public has the opportunity to comment on the proposed guidelines, entitled "The Regulation of Genetically Engineered Animals Containing Heritable rDNA Constructs," until November 18, 2008.

"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 Center for Veterinary Medicine Director Bernadette Dunham. "We look forward to the public comments to help refine our thinking and approach."

 

For more information about genetically modified foods, please visit Natural Standard's Genomics & Proteomics database.

Comments

[Lawrence Mayhew]

The use of herbicides has has dramatically increased since the introduction of GMO corn and soybeans because of herbicide resistance building up in the weed population, "commonly" referred to as SUPER WEEDS.

[dana]

If meat from genetically engineered animals is not available for consumption in the US, then I’m confused as to why the FDA has guidelines focusing on animals that would be used as foods or medications? Unless, this is where we’re headed.

And how will producers of GE animals “prove” that the food is safe? How and in who will they test this?

Also, if Angus beef gets labeling, so should genetically engineered animals. After all, labeling would help consumers with preferences. If GE meats will be sold in grocery stores, I want to see labeling that it is GE. Just as medications have reported side effect post-marketing, there may be some adverse effects discovered only after the GE product gets put in grocery stores, despite what the producers have shown for safety.

[marianne]

Reading articles like this really makes me seriously consider becoming a vegan. The fact that the FDA is not going to require that genetically engineered meat be labeled is disgusting to me. What if they make some kind of mistake in the genetic engineering of meat that makes me sick in some crazy new way? I wouldn't even be able to tell if it was caused by genetically engineered meat because there is no label on the package at all. Information like this is one of the reasons the market for organic food is growing so rapidly.

[HL]

Labeling GE products is a must because it helps consumers know what products they are getting. Consumers have a right to know and choose what's best for them. I am assuming that these guidelines would address the safety of these products.

[Mark]

Dana, I totally agree with you about labeling meats that are from GE animals. I feel like consumers have the right to know and then choose what they would like to buy. This might cause some problems because people might also demand that GE produce also be labeled, which I currently don’t think is.

[Lawrence Mayhew]

There are safe alternatives to genetically modified organisms. The problem with conventional agriculture is that it relies heavily on nitrogen fertilizers to grow less expensive, low-quality forages. When eaten by livestock, conventional meat has lower concentrations of all major and micro nutrients, essential fatty acids, etc. Pasture-raised, grass-based meat and poultry production, which considers bioavailable soil calcium as the major limiting factor in forages, overcomes all of the problems that GE products purportedly address. GE organisms are prohibited in organic production.

[liz]

The FDA says that the genetically modified foods need to be proved safe for consumption but do not have to be labeled. What kind of testing is going to be done to prove safety? Is there going to be an experiment or follow-up to see if there are any long0term health effects? Hormone- and antibiotic-fed animals were thought to be safe with no health consequences. Personally, I do not want to eat meat products that are from genetically engineered animals. I strongly believe that the genetically modified food should be labeled so that the consumer can make a conscious decision.

[Drew]

Liz, you are totally right. Knowledge of the long-term side effects is crucial because we don't want to put these types of foods out on the market and then come to realize that they are causing serious health problems! Hopefully, the FDA will have clear guidelines on what type of testing must be done and also enforce that this testing is done properly.

[SUMA]

I agree with the others that GE foods should be labeled. Consumers have a right to know what they are purchasing and eating.

The article goes on to state that, “According to the FDA and USDA, there are more than 40 genetically modified plants that have completed all of the federal requirements to be sold in the United States.” So, I guess my question is -- are they being sold here now? As consumers, would we even know, as no special labeling is required? I must admit that this is not a topic that I have followed closely. Apparently, genetically engineered (GE) animals were first developed in the 1980s.

My initial thoughts/feelings tend to focus on potential ethical issues -- it just does not seem right to be “messing with” DNA; however, I am open to learning about other potential benefits that could occur -- i.e., new pharmaceuticals, food production, etc.

[Janna]

When will it stop? I also am thinking about becoming a vegan.

[k.Kelley]

This Is this ridiculous! Long-term studies are needed.  Thank you for this blog. I certainly will send my thoughts to the Web site mentioned. The term "safe" to the FDA does not mean safe for long-term effects. It only means safe from immediate harm such as bacteria content or contamination/purity. What about the long-term impact? Have we not seen unexplained increases in many diseases lately such as ADHD in children? Could these genetically engineered meats lead to an increase in even more abnormalities? We need long-term studies!

[jonathan]

It may take a while before genetically engineered animals may be deemed safe to eat in the long-term. This concept of GE meat is still new and therefore, welcomes skepticism, as it should. Based on the comments above, many will agree that labeling or differentiating origins of meat is highly necessary for this reason.

[tracy]

I do agree with Lawrence on these questions regarding the safety of the GE meats. I don’t know how they (producers) of GE meats will prove that their products are safe for the consumers to eat. If these GE animals are intended for food use, I believe they must be labeled as such so that the consumers know to make their choices. I know that the field of genetic engineering "cutting edge technology" with lots of implications, but regardless, the GE meats have to be proven safe before they are put out in the market.

[beth]

I think that genetically engineered meat shows how innovative our scientific community has become. It is, in my opinion, developed through good intentions, and if we are not opposed to stem cell research, we should not be opposed to genetically engineered meat. It has been reported that this could mean having a steady supply of fish and cattle that will be resistant to mad cow disease, and even eggs from new chickens that will be healthier for your heart.

[PK]

To those of you considering a vegan diet as a result of GE meat, we already have GE vegetables. Labeling is the only way that you would be able to make the individual choice of what you do and don’t want to eat.

[charlotte]

I completely disagree with Beth. Stem cell research is completely different from genetically engineered meats. Stem cell research, while controversial, is being researched extensively to make great strides in the medical field and learn more about treatments for previously untreatable conditions. Genetically engineered meats are not completely necessary in the world; perhaps if we took the time and money used in this research and gave it to ranchers and farmers raising organic animals, we would have plenty of meat for everyone, and genetically engineered meat wouldn't be needed.

[justina]

The LA Times this past September also had an article on this topic. For those of you who are Massachusetts residents, did you know that a company in Waltham has produced genetically engineered salmon? According to the article, Aqua Bounty Technologies Inc. is hoping to sell their fish once the FDA has established guidelines. The fish from Aqua Bounty in Waltham grow at a faster rate, reaching full size in 18 months instead of 30.

[pn]

Why should anyone be making genetically engineered animals anyway? It is inherently wrong for us to try and manipulate the heredity of animals. It is not our place to change the essential characteristics of a horse or a chicken, nor can we be sure that genetically engineered animals will produce milk or meat that is absolutely safe to eat. Thus, labeling these GE products is absolutely a requirement.

[vanessa]

How soon do you think this is going to happen? I see organic products everywhere I go now. Aisles dedicated to this and grocery stores dedicated to organic products. It’s a booming sphere of food. It’s the earthy crunchy thing. Will genetically engineered animals be part of this realm too? Should I expect to see GE meat in my grocery store in the next year? This is very interesting and innovative.

[missy]

I agree with pn. Genetically engineering animals is not something that has a role in our lives, and it does not need to be done in order to continue thriving on this planet. If mistakes occur in the genetic engineering of animals, what would the implications be? New diseases? New twists on current illnesses, that may not be curable? I think one should look at the risks that could come out of this and spend this research money on other sustainable ways of improving our agriculture, rather than introducing a potentially dangerous means of increasing our food supply.

[Becca]

To clone an animal, a cell nucleus is taken from an “elite” animal, implanted into an egg whose nucleus has been removed, cultivated into an embryo in a lab, then implanted into the womb of a surrogate mother of the same species. Wow. This could definitely be a very controversial topic. It’s difficult and expensive and can cause premature death of young animals. Before I looked into the topic I was mortified by the thought.

However, after doing some research, I don’t know if genetically engineering animals is such a bad thing. Not so much cloning hot pink pigs and rainbow-colored zebras so you can show them off. But creating GE animals that carry specific genes may solve major problems. There is “no significant change in nutritional value,” and if there is, it needs to be on the label.

The fact that the FDA is even considering that we could someday be eating these GE animals means there needs to be specific guidelines, which is a good thing. For years, people have been consuming GE fruits and vegetables -- maybe not even realizing it. This could be another fight against chronic health problems, especially in farm animals. I do believe that these foods would NEED to be labeled.

[dp]

GE labeling should be a requirement. Consumers should know whether the meat (ie pork, chicken, beef, lamb, etc.) they’re consuming is from a genetically altered animal. Also, having the producers of genetically engineered animals prove that their products are safe to eat seems questionable at best. They should have an independent agency conduct studies on the long-term safety of consuming genetically engineered animals before GE animal products hit our supermarkets.

[Pam]

All GE food should be labeled as such. I think even the fruits and vegetables that we have been eating, without knowing if they are GE, should be labeled too. Over the past few decades or so, we have noticed increased food and nut allergies, incidence of asthma, eczema, etc. How do we know GE food has not contributed? Unfortunately, we may never to able to draw that correlation between GE foods and certain illness, but that mistake should not be repeated in the future with GE animals used for food. Without knowing who's consuming what, we cannot conduct any studies to understand long-term effects. But more importantly, consumers do not know what they are eating, and they can't even make informed decisions.

[K Kelley]

Long-term studies are needed! And thank you for this blog. I for one will certainly send my thoughts to the Web site mentioned. The term "safe" to the FDA does not necessarily mean safe for long-term effects, it only means safe from immediate harm such as bacterial content, contamination/purity or short-term impact. What about long-term impact? Have we not seen unexplained increases in many diseases lately such as ADHD in children? Could the genetically engineered products already on the market possibly be involved with the increase of these or other disorders?

[Anna H.]

Genetically engineered animals will definitely boost the country’s economy by yielding improved products. In the modern era, where demands have become more than the supplies, where the public needs a variety of products and where the public has become more health conscious, an introduction of genetically modified/ engineered animals will be promising. The whole agriculture sector has been revolutionized by the introduction of "Golden rice," HFSC, high-yielding wheat/cotton/rice varieties, virus-/disease-resistant varieties and many other examples. Likewise, genetically engineered animals have a very promising role to play in future biotechnology research projects.

[Jake]

This news disgusts me greatly! I can't believe the FDA is holding this information back from consumers when the consumers have every right to know if a product is a GE product. This is very disappointing! This and other articles I read about the FDA makes me reconsider if their goal is truly consumer safety or economic gain. I'm definitely starting to believe it's for economic gain.

Another example is drug approval. Did you know that the FDA is funded by some pharmaceutical companies as an incentive to approve their new drugs? The product may or may not be safe, but is still approved and marketed only to find out a year or two later that it has been recalled due to safety concerns after the pharmaceutical company has already made billions of dollars in sales at the expense of our health. So how can we tell as consumers if the food or the drugs we consume are truly safe? Can we rely on this kind of regulation?

[Mario]

I can't believe the FDA is holding this information back from consumers! That disappoints me greatly! It’s true when you hear people say that we honestly don’t know what we’re eating anymore these days. Then you wonder why normally healthy people die from unexplained illnesses.

[SLC]

No, no, no, FDA. No. I do not agree with FDA's decision to not label genetically engineering animals. I have a right to know if the chicken I am eating had eight wings and three legs. Food politics and history have shown us that modified foods do not show any negative effects until much later down the line. For instance, the use of antibiotics in poultry has caused some cases of antibiotic resistance. Also, antibiotic resistance takes years of exposure to develop. What if the harm caused by genetically engineered livestock doesn't become known until years from now? Just as the case of bovine spongioform or mad cow disease taught us, we must know where our meat comes from.