Biotechnology Issues

What is Biotechnology?

The USDA defines agricultural biotechnology as "a collection of scientific techniques, including genetic engineering, that are used to create, improve or modify plants, animals and microorganisms. Using conventional techniques, such as selective breeding, scientists have been working to improve plants and animals for human benefit for hundreds of years. Modern techniques now enable scientists to move genes (and therefore desirable traits) in ways they could not before—and with greater ease and precision." In the past both animals and crops were bred for desirable traits, by selecting the most desirable offspring and using that for breeding stock. The difference with biotech crops and those selectively bred is the use of recombinant DNA (genetically engineered DNA prepared in vitro by cutting up DNA molecules and splicing together specific DNA fragments usually from more than one species or organism) to genetically modify crops or animals.

"Biotech," "genetically modified," and "bioengineered" are terms that are used interchangeably. These are often referred to as "GMO," genetically modified organism, and "GM," "genetically modified." The term "transgenic" means having chromosomes into which one or more genes derived from a different species have been incorporated. It is commonly used when referring to animals that include genes from another species. These animals can also be referred to as genetically modified animals. The term "cloning" refers to asexually produced progeny, created from a single somatic cell of its parent that is genetically identical to it. To clone an animal, the nucleus of a cell, such as a skin cell, is removed and placed into an egg cell that has had its nucleus removed. With stimulation, the combination forms an embryo, which can be placed into an animal's womb until it's ready to be born.

The benefits of agricultural biotechnology are that these products can be utilized to reduce pesticide use; to resist plant diseases and increase crop yields; to promote nutritional values in food and to combat human diseases.

Some environmental and consumers groups believe that bioengineered crops have not been adequately studied and have the potential to cause environmental damage, as well as, negative health consequences.

Regulating Biotechnology

Three Federal agencies are principally involved with regulating biotechnology—the US Environmental Protection Agency (EPA) (microbial/plant pesticides, new uses of existing pesticides, novel microorganisms), the US Food and Drug Administration (FDA) (food, feed, food additives, veterinary drugs, human drugs and medical devices) and the US Department of Agriculture (USDA)(plant pests, plants, veterinary biologics).

The FDA regulates transgenic animals. Certain bioengineered animals can be viewed as containing new animal drugs because the bioengineering alters the structure/function of the animals, which is the key part of the definition of a drug.

In January, 2009, the Food and Drug Administration issued a Final Guidance Document for industry on the regulation of genetically engineered (GE) animals. The guidance explains the process by which FDA is regulating GE animals and provides a set of recommendations to producers of GE animals to help them meet their obligations and responsibilities under the law. While the guidance is intended for industry, FDA believes it may also help the public gain a better understanding of this important and developing area.

The USDA, on April 15, 2003, established an Advisory Committee for Biotechnology and 21st Century Agriculture (AC21). AC 21 was established to provide information and advice to the Secretary of Agriculture on topics related to the use of biotechnology in agriculture, and is comprised of 18 individuals representing the biotechnology industry, the farming community, the seed industry, food manufacturers, commodity processors and shippers, environmental and consumer groups, academic researchers, and experts on bioethics and legal issues.

The FDA Center for Veterinary Medicine has a Web page devoted to Biotechnology Issues. The USDA also has a web page devoted to Biotechnology.

Labeling Biotech Foods

Pet food produced in the US may contain biotech material, as a significant portion of the soy, corn and other grains grown in the US are grown from biotech seed. Although there are no biotech animals yet approved to enter the human food supply, the FDA notes that a very limited number of biotech animals have been approved for rendering into animal feed components. Many entities are working on developing biotech animals for food. As an example, a transgenic salmon has been created that will reach its market weight much more rapidly than non-biotech salmon.

Because there are numerous groups that object to bioengineered foods, a mounting number of manufacturers of food products are including in their labels statements that a product is "non-GMO," or "GMO-free," indicating that the product does not contain any "genetically modified organisms." Foods derived from biotechnology must be labeled only if they differ significantly from their conventional counterparts, for example, if their nutritional content differs or there is a potential to cause allergic reactions.

In January 2001, the FDA published draft guidance for industry called "Voluntary Labeling Indicating Whether Foods Have or Have Not Been Developed Using Bioengineering". Although only a draft, the proposed guidance represents FDA's "current thinking" on the appropriateness of labeling statements relating to bioengineered materials. The proposed guidance applies to human food and animal feed. The FDA received more than 55,000 comments on this issue.

Statements about foods developed using bioengineering

In its proposed guidance document, the FDA's focus is whether any statements made on the label are misleading. If there is a significant difference in a finished product because of biotechnology, such that the common or usual name no longer adequately describes the new food, the name must be changed to describe the difference. Similarly, if the improvement makes a significant difference in the finished product, disclosure of the difference may be required. Unless there is a significant difference, there is no requirement that any product be labeled stating that it contains bioengineered food.

Statements about foods that are not bioengineered or that do not contain ingredients produced from bioengineered foods

"GMO" is an acronym for "genetically modified organism," and "GM" means "genetically modified." The FDA has conducted consumer focus groups, and data indicates that consumers do not understand the acronyms "GMO" and "GM," and prefer label statements with spelled out words that mean bioengineering.

Terms like "not genetically modified" and "GMO free," or that include the word "modified" are not technically accurate unless they are clearly in a context that refers to bioengineering technology. The term "free" in a claim for absence of bioengineering can be inaccurate because the term "free" can only be ensured when there is a definition or threshold above which the term could not be used. FDA does not have information with which to establish a threshold level of bioengineered constituents or ingredients in foods for the statement "free of bioengineered material". FDA recognizes that there are analytical methods capable of detecting low levels of some bioengineered materials in some foods, but a threshold would require methods to test for a wide range of genetic changes at very low levels in a wide variety of foods. Such test methods are not available.

The FDA suggests that claims stating that a food does not contain bioengineered ingredients could be misleading; if there is any ingredient in the food that is bioengineered, if there are no marketed bioengineered food ingredients in that category of foods, or if the claim cannot be substantiated. Validated testing is the most reliable way to identify bioengineered food, but for many foods, such as highly processed foods such as oils, it may be difficult to differentiate bioengineered foods and ingredients. The proposed guidance document can be found on the FDA's Website.

Organic Food Cannot be Bioengineered

The USDA's organic standards provide that a food cannot be considered organic, if it contains bioengineered ingredients.

Labeling Bioengineered Foods for Export

European Union

Public opinion in Europe is largely considered to be the biggest impediment to global adoption of biotech crops.

The European Union requires traceability and labeling of food and feed products (including pet food) that contain GMOs made as of April 18, 2004. This is the first time that there are comprehensive labeling requirements for GM feed in Europe.
All feed and food products that contain a threshold of no higher than .9% of genetically modified materials will have to be labeled "this product contains genetically modified organisms" or "produced from genetically modified (name of organism)." Non-GMO foods must be labeled if the level of "adventitious presence" of GM materials exceeds 0.9%. The labels must appear in the same size font as in the list of ingredients. Avoid statements such as this product "may" contain genetically modified organisms.
The labeling requirement is irrespective of whether there is DNA or protein of GM origin in the final product. Labeling is based on genetic origin.
The regulation provides that new GMOs must be authorized for use as food and feed. Therefore if an unapproved food or feed has greater than 0.5 % not approved adventitious material, the food must not be placed in the market.
If the food or feed is different for the conventional counterpart with regards to composition, nutritional value, intended use, or has implications for health or raises ethical or religious concerns, information related to the difference must be included in the label.
The European Food Safety Authority will conduct scientific risk assessments to determine whether the new GMOs should be authorized.
The new EU regulations also require traceability, which provides the means to track the product through distribution chains. The rules require business owners when using or handling GM products to transmit and retain information on the GM content one step forward, and one step back, when each component is placed in the market. Records must be kept for 5 years.
No labeling required for:
Animals or animal products fed GM feed;
Food or feed produced "with" a GMO. (These include processing aids, extraction solvents, carriers for flavorings, enzymes)

Note too that processed products which were already in distribution as of April 18, 2004 do not have to comply with labeling requirements. The regulations apply to products which are made on or after that date.

More information about the requirements and lableing for GMO legislation for  food and feed in the EU. 
 

The Codex Alimentarius Commission

The Codex Alimentarius Commission was created in 1963 by United Nations Food and Agriculture Organization (FAO) and World Health Organization (WHO) to develop food standards, guidelines and related texts such as codes of practice under the Joint FAO/WHO Food Standards Program. The mission of Codex is to protect the health of consumers and to ensure fair trade practices in the food trade, and to promote coordination of all food standards work undertaken by international governmental and non-governmental organizations. Recently the Codex Alimentarius Commission adopted an agreement on assessing the risks from genetically modified foods. The guidelines are intended to make the analysis and management of risks associated with GM foods uniform across Codex's 169 member countries. This includes pre-market safety evaluations, post-market monitoring and product tracing.

Cartagena Biosafety Protocol

The Cartagena Biosafety Protocol is the first legally binding international agreement governing the movement of living modified organisms (LMOs) across national borders, took effect on September 11, 2003. In June 2003, the 50th country to ratify the Protocol triggered the countdown to implementation. Although the U S has not ratified the protocol, US exporters to countries that are parties to the treaty, must follow its rules.
Advance Informed Agreement - Prior to the first shipment of LMOs into a country that has signed the protocol, the exporter will have to provide notification to the country accepting the LMOs, with sufficient information to enable the country to make an informed decision regarding the LMO.
Biosafety Clearinghouse - Member countries will be required to use the Biosafety Clearinghouse, for exchanging information. Governments must provide information on the domestic use of a LMO commodity within 15 days of making a decision.
Documentation - All shipments of LMOs that will be introduced into the environment, must be identified with each shipment, and must identify the characteristics of the LMOs in each shipment.

The Web site for the Convention on Biological Diversity has the full text of the protocol, as well as additional information.

Genetically Modified Pets

Animals to Fit Their Owner's Taste

Aquarium fish that glow in the dark or cannot swim, dogs without hair, and cats without tails are all potential pets. What about adding genes from cold water fish that would allow tropical fish to live in unheated aquariums? These types of animals are all apparently under development. Recently the first animal that was created by bioengineering has entered the pet marketplace. This first genetically modified pet is a zebra fish that has had jellyfish and marine coral genes added. Zebra fish are usually colorless. Dubbed "Night Pearl," the new fish are fluorescent, and glow in the dark in red and green patterns. Many are outraged and fear that if the fish are ever let loose, they could harm the natural populations. Others believe that a modified pet that doesn't produce allergens, such as cats, could be a great boon to the pet industry.

Cloning Pets

In 2001 the first cat to be cloned, named Copycat, was produced. The firm cloning the cat was developed to see whether it was feasible to clone pets. Apparently there was a great deal of interest in this concept from pet owners facing the loss of their beloved pets. However, when a pet is cloned, such as Copycat, there is no assurance that the animal will look identical to the animal it was cloned from, nor exhibit identical behavior patterns. From the limited animals that have been cloned, it appears that many of these animals suffer health problems. A high percentage of the cloned offspring have anatomical or physiological defects that cause them to be aborted, die early in life, or be put to death because of their deformities. Certain genes have unknown functions, and the elimination of some genes to be replaced by others may bring unknown problems.

Ecological and Health Concerns

The major area of concern is that GM animals will escape into the wild, where they will spread their modified genes. For example, if the modified aquarium fish, that can survive cold temperatures, were released into the wild, there would be tropical colored fish living in cold waters where they are not native.

The National Academies of Science/ National Research Council has prepared a report on some of the risks and benefits as well as history of cloned animals. Those risks include health risks to the offspring and  to the mothers

Ethical Concerns

Another area of concern is the ethical considerations of creating modified domestic pets with fundamentally objectionable changes to their nature—such as creating cats without a hunting instinct. Animal welfare issues must also be considered for transgenic animals. Objectors to cloning pets cite pet over-population as a reason why pets should not be cloned.

FDA: The FDA has done risk assessments on cloning animals and has a more information on their page on Cloned Animals.