Animal & Veterinary

General Q&A

The Technology
The Regulatory Process
Interactions with Other Branches of the USG and Other Countries
What’s the Agency asking for in the Guidance?
Related Issues

The Technology

Q: What is genetic engineering?

A. Genetic engineering generally refers to the use of tools of modern biotechnology and molecular biology to specifically introduce or alter characteristics or traits in organisms. Scientists can use these tools to introduce new genetic material, or delete existing genetic material to introduce intended new or altered traits or characteristics.

Q: What kinds of GE animals are in development?

A. Many kinds of GE animals are in development. At this time, the largest class of GE animals is being developed for biopharm purposes—that is, they are intended to produce substances (for example, in their milk) that can be used as human or animal pharmaceuticals. Another group of GE animals are under development for use as sources of scarce cells, tissues, or organs for transplantation into humans (xenotransplant sources). Yet others are intended for use as food and may be disease resistant, or have improved nutritional or growth characteristics. And others include animals that produce high value industrial or consumer products, such as highly specific antimicrobials against human and animal pathogens (e.g., E. coli 0157 or Salmonella).

Q: How are GE animals different from non-GE animals?

A. From a scientific perspective, the only intrinsic difference is that GE animals contain an intentional modification of the genome using the tools of modern biotechnology that gives them a new trait or characteristic, such as producing a pharmaceutical or growing faster. The degree of difference between a GE animal and its conventional counterpart will depend on the new trait that the GE animal possesses.

Q: Do all GE animals pass their new traits on to their offspring?

A: GE animals that are developed to pass their new “GE” traits on to their offspring are referred to as having heritable traits. The initial GE animal and all of its descendants that have inherited the GE trait are called GE animals. This guidance specifically addresses only GE animals that have heritable GE traits.

In general, most GE animals have an altered genome introduced into early embryos or cells that go on to make embryos that develop into the GE animal. The altered genome is heritable because it will be in every cell of the resulting animal, including those that are responsible for making sperm and egg for the next generation.

The term “GE animal” thus includes all of the animals descended from the initial GE animal that have inherited the altered genome. This is different from the term “animal clone,” which does not include the sexually-derived offspring of animal clones.

In other cases, GE animals contain genomic alterations that are not intended to be inherited—for example, animals being treated with gene therapy. These DNA alterations and constructs are not found in the germ cells of those animals, and their offspring will not contain the rDNA construct.

Q: What’s the difference between animal clones and GE animals?

A: Animal cloning is a method of asexual reproduction, and results in the birth of one animal (the animal clone) that is a genetic copy of another animal. If the animal clone becomes a parent, its children are not clones, because they will have been born through sexual reproduction. So, the two things to remember about an animal clone are that (i) they are animals born as a result of asexual reproduction, and (ii) they have no new genes in them, that is, they are the same as the animal of which they are a copy. For more information, see Animal Cloning.

Genetic engineering is a method of altering the genome of an animal. Thus, it is a method of altering an animal, not copying it. A GE animal contains new DNA (the rDNA construct) that gives the animal new traits. If the rDNA construct is stably inherited, then future generations of the initial GE animal will also contain the rDNA construct, and will also be GE animals. So, while cloning is a method of reproduction, genetic engineering is a method by which the genetics of an animal can be altered.

The animal clones that were the subject of FDA’s previous risk assessment are “just clones”—that is, they are copies of individual traditionally-bred animals, and do not contain any rDNA constructs. What can be confusing is that an animal clone can be genetically engineered (i.e., have an rDNA construct introduced into it), and a GE animal can be reproduced by cloning. Our guidance covers GE animals, irrespective of whether they were reproduced by cloning. It does not cover animal clones that do not contain an rDNA construct, i.e., non-GE animal clones (or “just clones”).

Q: What are the known/potential benefits of genetically engineering animals?

A: The benefits depend entirely on the traits that are introduced. For example, scientists are attempting to develop GE cattle that are resistant to bovine spongiform encephalopathy, widely referred to as “mad cow disease.” Some GE animals will grow more quickly, requiring less feed. Some GE animals have been altered to reduce their environmental impact by virtue of producing a lower level of pollutants in their wastes. Other GE animals may have improved fat composition, for example, increased levels of omega-3-fatty acids, providing a more healthful nutrient profile. Perhaps most importantly, scientists are developing GE animals that will produce certain human pharmaceuticals that are very difficult to produce in sufficient quantities by other means. An example of this is the potential ability to completely change the way in which certain chronic diseases, such as bleeding disorders, are treated. Currently, because clotting factors are so rare and difficult to obtain, people are treated only following acute attacks. If there were to be an increased supply of these clotting factors from GE animals, patients might be able to have much of their bleeding controlled by the regular administration of the medicine. In that way, these patients would potentially have a more normal ability to control bleeding.

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The Regulatory Process

Q: What did the Agency issue?

A: After soliciting public input, the Agency issued a guidance on FDA’s current thinking on the regulation of genetically engineered (GE) animals and their products. The guidance document is intended to help industry understand the existing statutory and regulatory requirements as they apply to GE animals and their products and to inform the public about the process FDA is using to regulate them.

Q: How does the agency regulate GE animals and their products?

A: FDA regulates GE animals under the new animal drug provisions of the Federal Food, Drug, and Cosmetic Act (FD&C Act), and FDA’s regulations for new animal drugs. This guidance is intended to help industry understand the statutory and regulatory requirements as they apply to these animals, including those of the National Environmental Policy Act (NEPA), to inform the public about the process FDA is using to regulate GE animals, and to gather input from the public and the regulated industry.

Q: Is FDA’s regulation of GE animals and their products consistent with how FDA regulates conventional new animal drugs?

A: Yes. We are using the existing laws and regulations under which we regulate conventional new animal drugs and applying them to GE animals. A major purpose of the guidance is to explain how those regulations apply to GE animals.

Q: Are GE animals “drugs”?

A: No, GE animals are not drugs. Rather, the agency is regulating GE animals under the new animal drug provisions of the FD&C Act. The FD&C Act defines a new animal drug as “an article (other than food) intended to affect the structure or any function of the body of … animals.” A recombinant DNA (rDNA) construct intended to affect the structure or function of an animal meets the definition of a new animal drug, regardless of whether the resulting GE animals are intended for food, or to produce pharmaceuticals or any other substances. As a short hand we sometimes refer to regulation of the article in such GE animals as regulation of the GE animal.

Q: Do all components of the new animal drug approval process apply to foods imported into the U.S. that are derived from GE animals raised in other countries?

A: No, not all components of the NADA process apply to foods imported into the U.S. The guidance notes the possibility of applying for an import tolerance instead of a new animal drug approval in such situation.

Q: What are the elements of the new animal drug approval process?

A: The guidance recommends a review process that includes seven categories:

  • Product definition: a broad statement characterizing the GE animal and the claim being made for the GE animal;
  • Molecular characterization of the construct: a description of the rDNA construct and how it is produced;
  • Molecular characterization of the GE animal lineage: a description of the method by which the rDNA construct was introduced into the animal and whether it is stably maintained over time;
  • Phenotypic characterization of the GE animal: comprehensive data on the characteristics of the GE animal and its health;
  • Durability plan: the sponsor’s plan to demonstrate that the alteration will remain the same over time, and continue to have the same effect.
  • Environmental and food/feed safety: the assessment of any environmental impacts, and for GE animals of food species, an assessment of the safety of food derived from those GE animals for humans and/or animals;
  • Claim validation: a demonstration that the GE animal does fulfill the product definition stated in the beginning of the review process.

Q: Why did the Agency issue this guidance at the time that they did?

A. The agency had been regulating these animals under the new animal drug provisions of the Act since developers first approached us with GE animals. Based on our interactions with developers, we believed we had a good idea of the kind of guidance that would be most helpful to industry. We also believed that publishing the guidance will give the public a better understanding of FDA’s role in this important and developing area. Finally, with the adoption of the Codex Alimentarius 1 Guideline for Assessing the Food Safety of Food from rDNA Animals (June 2008; disclaimer icon), which provided internationally-recognized recommendations for assessing the safety of food from GE animals, we believed that it was important that developers around the world fully understood the rigorous regulatory requirements that these animals and the food products from them need to meet in the United States. It is our intention to modify the guidance as this and related technologies used to make products regulated under the new animal drug provisions change, of if the agency finds that through experience, the approaches described may need revision or clarification.

Q: Why did the Agency issue a guidance and not a regulation?

A: Existing statutory requirements and FDA’s existing regulations for new animal drugs are applicable to, and appropriate for, GE animals. Therefore, we do not believe we need new law or regulation at this time to address GE animals and their products. However, we intend to issue additional guidance to describe the applicability of the new animal drug approval requirements to GE animals and their products.

Q: What is the legal basis on which GE animals are being regulated?

A: Under the FD&C Act, “articles (other than food) intended to affect the structure or any function of the body of man or other animals” are defined as drugs. An rDNA construct that is in a GE animal and that is intended to affect the animal’s structure or function meets the definition of an animal drug. This is true regardless of whether the animals are intended for food or for some other purpose such as to produce pharmaceuticals. The FD&C Act generally makes it unlawful to introduce unapproved new animal drugs into commerce. Therefore, premarket approval requirements apply to GE animals before they are marketed, and potential significant environmental impacts, if any, must be examined before approval as required by NEPA. The implementing regulations for new animal drugs are also applicable to GE animals, as they are appropriate to support the particular submission (21 CFR 514.1(a)).

Q: Does issuing a Guidance for Industry imply that this approach is voluntary?

A: No. A product that meets the definition of a new animal drug is generally required by statute and regulation to have an FDA-approved New Animal Drug Application prior to marketing. In order for FDA to approve such an application, the FD&C Act requires that the sponsor demonstrate that its product is safe and effective. Although the Guidance does not itself impose any new requirements, we are issuing it to explain how existing statutory and regulatory requirements apply to GE animals and their products, and to provide recommendations on how sponsors may meet these responsibilities.

Q. Are all GE animals subject to regulation under the new animal drug provisions of the Act?

A: Yes, any animal containing an article such as an rDNA construct intended to alter its structure or function is subject to regulation by FDA prior to commercialization. Based on risk, there are some GE animals for which the agency may exercise its discretion and not enforce the requirement for an approval. In general, these include laboratory animals used for research. On a case-by-case basis, the agency may consider exercising enforcement discretion for GE animals of very low risk, such as it did for an aquarium fish genetically engineered to fluoresce in the dark.

Q. Why is the agency taking a different approach for GE animals from the one taken for clones?

A: In the case of clones, the agency first needed to determine whether food from clones posed any additional risks compared with food from more conventionally bred animals. Following the completion of a comprehensive risk assessment, the agency was able to determine that cloning fell on the continuum of assisted reproductive technologies, and that cloning poses no new risks to the health of animals involved in the cloning process or to food from cattle, swine, or goat clones or the progeny of clones of any species traditionally consumed as food. Additionally, clones are not different from non-clones with respect to their DNA; only the method by which they are produced is different. Therefore, FDA determined that no additional regulatory oversight was necessary.

In contrast to clones, GE animals have intentionally been changed. That change may affect the health of the animal, as well as the safety of food from the animal. Therefore, there are risk-based reasons for FDA to require their approval.

Q: Why is this different from the way in which GE plants are being regulated?

A: There are a number of reasons for the difference. One overarching reason is that, unlike in some other countries, the US has not considered it appropriate to create a “novel food” regulation. That is, the US does not subject foods from GE organisms to a specific new regulation simply because of their GE status. Rather, the US has so far found that its existing laws can be applied to provide appropriate regulatory controls over GE foods. And because US law generally treats plants and animals differently, and treats food from plants differently from food from animals, the regulatory procedures for GE plants will, of necessity, differ from the regulatory procedures for GE animals.

Another reason is that, unlike plants, animals can transmit diseases to humans, and in some very notable cases, are the origin of viral diseases in humans (e.g., swine flu). Depending on the nature of the modification to an animal, including the nature of any DNA sequences used to introduce or insert the rDNA construct into the animal, genetic engineering can enhance (or minimize) risks to human health. Although food from plants can be contaminated with human pathogens (usually from animals), and can thereby cause human illness, plants themselves ordinarily do not transmit human diseases. Genetic engineering does not change this. Therefore, GE animals can pose human health risks that would not arise with GE plants. The different regulatory approaches address these different risks.

Q: Is the safety of food from GE animals being held to a different standard from the safety of food from GE plants?

A: Food sold in the United States must be safe, whether it is from plants or animals, and whether it is GE or non-GE. Although the regulatory process for food from GE animals is different than that for food from GE plants, as dictated by different statutory requirements, ultimately they both must be safe to be legally marketed. In fact, the food safety assessments are quite comparable, with some appropriate differences to accommodate the key differences between plants and animals, and look at the same information as recommended in the respective Codex guidelines that provide internationally-accepted recommendations for assessing the safety of foods from GE plants and GE animals.

Q: Are there special concerns related to GE animals that are not concerns for GE plants?

A: Most of the food safety issues are the same. However, all animals, including GE animals, can cause zoonotic diseases (animal diseases that cross over to humans) because some viruses and microorganisms from animals can infect humans. Because it is possible to genetically engineer animals using viruses or segments of DNA that can recombine and possibly transfer to humans or other animals and cause disease, there are some specific issues that must be evaluated in GE animals that are not relevant in GE plants. Addressing potential risks of introducing and spreading livestock pests or disease is also within the scope of USDA’s APHIS regulatory authority.

Q: Are there GE animals in the food supply?

A: On November 19, 2015, FDA approved an application related to AquAdvantage Salmon, a GE Atlantic salmon. Although these salmon will be bred in Canada, and raised in Panama, food from these salmon will be imported into the U.S. For details on the kinds of studies that were conducted to assess food safety, please see the Freedom of Information, Section IX. GeneticallyEngineeredAnimals/UCM466215.pdf.

FDA has been working closely with developers of GE animals to ensure that they are aware of the regulations, particularly with respect to disposition of investigational animals. In June of 2003, FDA issued a letter to the presidents of all US land grant universities informing them of their responsibilities to inform investigators at their universities that they should contact FDA if they were conducting investigations with GE animals of species traditionally consumed as food. Additionally, they were asked to remind their investigators of their responsibilities regarding animal disposition and record-keeping. To date, FDA has neither received requests, nor granted any food use authorizations for, investigational animals containing rDNA constructs.

Q: What is the role of the various components of FDA over GE animals?

A: The Center for Veterinary Medicine (CVM) is responsible for evaluating the safety and effectiveness of the regulated article (e.g., rDNA construct) in the GE animal, as it does for conventional new animal drugs. This includes the effects of the article (e.g., rDNA construct) on the safety of the GE animal as well as on the safety of foods from the GE animal, should the GE animal or parts of it be used for food or animal feed. In addition, CVM evaluates whether the GE animal has the properties claimed for it (e.g., that the GE animal has a particular different fatty acid profile or that a biopharm animal produces the pharmaceutical it is supposed to produce). For animals producing substances to be used in or as drugs, biologics, or devices for use in humans, the Center for Drug Evaluation and Research (CDER), the Center for Biologics Evaluation and Research (CBER), or the Center for Devices and Radiological Health (CDRH) has responsibility for reviewing its respective product. For animals producing substances to be used in or as veterinary biologics, APHIS regulates the veterinary biologic. CVM will consult with the Center for Food Safety and Applied Nutrition (CFSAN) on food safety issues if a particular question arises for which CFSAN has expertise that CVM lacks.

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Interactions with Other Branches of the USG and Other Countries

Q: How does the FDA propose to address GE insects?

A: We expect that other agencies also may have responsibilities associated with the oversight of GE insects. We engage in discussions with other agencies, including EPA and USDA's APHIS, to determine which agency has the authority to regulate particular GE insects, and may jointly issue future guidance to address GE insects. At this time, FDA is working with subject matter experts from other agencies on the review of an application for a genetically engineered mosquito.

Q: Are there any GE animals or food products from them currently in the US market or elsewhere?

A: The only GE animals known to be sold commercially in the U.S. are laboratory animals used primarily in medical research, and a type of aquarium fish that glows in the dark. In 2009, CVM approved a GE goat that produces a human biologic in its milk; the human product, ATryn, was approved by CBER. Most recently, FDA/CVM has approved the AquAdvantage Salmon, a GE Atlantic salmon, which although raised in Canada and Panama, will be imported as and sold as food in the U.S. We have been working with GE animal developers since the 1990s and have always made clear, including in a letter to all land grant universities, that food from GE animals could not be sold without prior FDA review.

Q: How many GE animals are there in the US?

A: As stated above, no GE animals raised for food use are currently approved for raising in the U.S. The GE goats that produce ATryn are housed in the U.S. under contained conditions. Investigational GE animals that are housed in the U.S. must provide for multiple methods of physical containment and identification. GE aquarium fish, known as GloFish, are currently for sale in the U.S. under an exercise of FDA's enforcement discretion, as are many GE laboratory rodents that are sold to aid in research around the world.

All of the remaining GE animals in the US are investigational, or research, animals. It is difficult at any one time to know exactly how many GE animals are on the ground, as some are being born, and others are being sacrificed as part of safety or effectiveness studies required for approval. Nonetheless, one of the primary clarifications that the guidance provides is that developers of GE animals of any species traditionally consumed as food must notify the agency that they are developing such animals, and cannot introduce them into the food supply without prior authorization from FDA.

During the investigational or research phase, sponsors (the developers of GE animals) are required to keep records of the amount of drug being developed. The guidance interprets that as meaning the number of GE animals being developed, whether they are being shipped, and the method of disposition. Further, all investigational animals must be labeled, or clearly identified as such, and be accompanied by a label indicating that they are not for human use without FDA approval. These records must be maintained for two years after the investigation concludes or an approval is issued. FDA has the right to inspect sponsor facilities and records with no advance notice. GE animals cannot be introduced into the food supply without explicit agency approval.

Q: Are GE animals or their products being developed in other countries? Have any been commercialized?

A. Yes, GE animals are being developed actively in many countries for both food and biopharmaceutical uses. For example, there have been multiple publications from Canadian developers of genetically engineered fish that grow more quickly, and pigs with smaller environmental footprints, as well as GE animals intended to produce human pharmaceuticals. In New Zealand, dairy researchers are looking to rDNA technology to affect the relative level of certain proteins in cows’ milk to make it more suitable for cheese-making. China has a major agricultural program that employs modern biotechnology to make more animal-based food available, aw well as for biopharm uses, and scientists from African countries are collaborating with aquaculturists in the US to develop GE tilapia that will grow quickly. Growth enhanced fish are also being developed in Cuba. Scientists at the Roslin Institute in Scotland are developing GE chickens to be resistant to avian influenza, and many countries are using GE animals to produce pharmaceuticals. This is a very active area of research, and we expect that many products are likely to start reaching regulators, and then the market, within the next decade.

With respect to commercialization, many GE laboratory animals are in use in research laboratories around the world, including those GE laboratory animals that are sold to laboratories to perform various kinds of testing.

Q: How do other countries regulate GE animals and their products?

A. Usually, when countries have premarket approval requirements for GE foods or “novel foods,” the requirements are the same whether the food comes from GE plants or GE animals. We anticipate that, like the U.S., most countries will evaluate the same information as that recommended in the Codex Alimentarius guideline on assessing the safety of foods from rDNA animals. Individual countries or regions (e.g., the European Union) will have their own ways of regulating GE animals, and differ according to their laws and regulations.

Q: What if a marketer wishes to import food into the US from a GE animal from another country?

A: FDA has a mechanism by which it can evaluate the safety of food from GE animals developed abroad and can establish an import tolerance to enable import of such food. In general, the information necessary to establish such import tolerance would be found in the sections of this guidance relevant to evaluating food safety and would be consistent with the information recommended for review in the Codex Guideline for the Conduct of Food Safety Assessment of Foods Derived from Recombinant-DNA Animals.

Q: Does the United States anticipate trade disruptions related to the development and commercialization of GE animals?

A. By the time GE animals enter the food supply, they will have received FDA approval and will have gone through a food safety assessment that reviews information consistent with the information recommended for review in the international rDNA animal food safety guideline recently adopted by the Codex Alimentarius. FDA works with the trade and other relevant agencies to develop a coordinated outreach program and to answer scientific or regulatory questions from its counterpart regulatory agencies in other countries, as a way to help minimize or prevent trade disruptions.

Unlike the release of the Cloning Risk Assessment, which determined that no further regulation was needed for certain clones and clone progeny, the release of this guidance clarifies that premarket approval is required prior to the introduction of GE animals or their products into commerce, and describes the rigorous regulatory process that must be completed. Given the recent adoption of the Codex guideline, we believe that the international community is well aware that such animals are under development and that there is a consensus approach for assessing the safety of food from them.

Q: Is the United States part of any international activities associated with GE animals?

A: The US is an active participant in a number of international organizations that address GE animals or their products, including Codex Alimentarius and OIE (the World Organization for Animal Health). In addition, FDA maintains a close relationship with its counterpart regulators around the world through our Office of International Policy, as well as individual interactions at international workshops and scientific or regulatory meetings.

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What’s the Agency asking for in the Guidance?

Q: When should developers of GE animals first come to the agency?

A: Developers are always welcome to contact the agency if they have any questions regarding whether the GE animals they are developing will need premarket approval, or whether FDA may exercise enforcement discretion over them. We recommend that developers first come to the agency early in the development of GE animals. We can then work closely with them during the investigational phase of the development of these animals to ensure that animals do not inadvertently enter the food supply and that data sets to address safety requirements are developed efficiently and appropriately.

Q: Are certain kinds of rDNA constructs considered “safe”?

A: All intended changes to the genome and the resulting GE animals will be considered on a case-by-case basis. At this time, we do not believe that certain alterations will be predetermined to be “safe” or “not safe”.

Q: What happens during the research phase of developing a GE animal?

A: The agency refers to the “research phase” as the “investigational phase” of the development of GE animals. During this phase, developers (referred to as sponsors), in general, can use various rDNA constructs and intermediates to arrive at a construct in an animal that they believe will serve as the progenitor of the line of GE animals that they wish to develop. We will work with sponsors to ensure that records are kept appropriately, that investigational animals are disposed of in a safe manner that potential environmental risks are assessed, and that data and information suitable to a New Animal Drug Application (NADA) are being developed.

Q: What kinds of information are required for an NADA submission?

A: In general, the guidance recommends that sponsors begin by developing a product definition. This is a short statement that describes the GE animal being produced, e.g., the rDNA construct in the GE animal, and the claim being made for the GE animal, i.e., the new trait that the animal is expected to have. The guidance recommends that sponsors fully characterize the rDNA construct that they will be using, including its ultimate location and stability in the genome of the GE animal’s lineage. In addition, the guidance recommends that sponsors evaluate the durability of the construct (i.e., determine whether it is stably maintained and expressed) in the resulting GE animals, ultimately over multiple generations. The guidance also recommends ways in which sponsors can meet the statutory requirements of safety as related to the health of the animal, and food or feed safety if animals are intended to enter the food supply. In addition, the guidance describes sponsors’ responsibilities under the NEPA to provide an assessment of potential environmental risks. Finally, the guidance provides recommendations to help sponsors meet their statutory requirements to validate the claim that is being made to demonstrate the effectiveness of the rDNA construct (i.e., that it does what the sponsor claims).

Q: How does the guidance address potential adverse effects on animal health?

A. The guidance recommends that the developer submit data and information addressing the health of the GE animals, including veterinary and treatment records, growth rates, reproductive function, and behavior. The guidance also recommends submission of data on the physiological status of the GE animals, including clinical chemistry, hematology, histopathology, and post-mortem results. And the guidance recommends submission of data addressing whether the rDNA construct or its expression products cause any direct or indirect toxicity to the animals.

Q: Does FDA address animal welfare issues? How do they differ from animal health issues?

A: Animal welfare generally refers to how animals are treated, including the conditions under which they are housed. To the extent that such issues affect animal health or the safety of products from the animals, FDA does take such issues into account in its review. However, other unrelated animal welfare issues are not within the scope of the guidance. USDA addresses animal welfare concerns of animals, other than livestock and laboratory animals. Laboratory animal welfare concerns are generally the subject of local Institutional Animal Care and Use Committees and the Association for Assessment and Accreditation of Laboratory Animal Care.

Q: How does the guidance address potential environmental risks associated with GE animals? Are concerns different for different kinds of animals?

A. Any potential environment-related issues would be a function of the traits or characteristics introduced into those animals, and the conditions under which those animals would be grown. For example, fast growing salmon to be grown in contained environments pose a different set of risks from cattle engineered to be resistant to a disease such as mastitis. FDA will consider potential environmental effects on a case-by-base basis. In general, the guidance recommends that, early in development, sponsors consult FDA about potential environmental issues, and that they consult with FDA prior to developing their approaches to environmental assessments so that we can agree on the risk questions to be asked and the resulting scope of the environmental review.

Q: Will it be safe to eat the food from GE animals?

A. FDA will only approve GE animals for use as food if it finds that food from the animal is safe to eat. FDA’s food safety evaluation will look at the same information as that recommended internationally by Codex Alimentarius in its guideline. For an example of the kind of studies that have been done for the AquAdvantage Salmon, please see the Freedom of Information Summary, Section IX, GeneticallyEngineeredAnimals/UCM466215.pdf.

Q: How will FDA evaluate the safety of meat or other food products from GE animals? How does the guidance compare with the Codex Guidelines for the Food Safety of Foods from rDNA Animals?

A: The FDA guidance essentially recommends the same information for evaluating food safety that the Codex Guideline does: the characterization of the rDNA construct, the safety of the new substance produced as a result of the rDNA construct, the health status of the GE animals, and a demonstration that the composition of food produced from the GE animal is safe. FDA uses the same standard for food safety of new animal drugs as for food additives: reasonable certainty of no harm.

Q: How does the guidance address the issue of disposal of GE animals, carcasses, or parts?

A: Animals or edible products from them containing unapproved new animal drugs may not be put into the food or feed supply without prior FDA authorization during the investigational phase of development. The same food safety standard is applied to investigational GE animals as for investigational animals treated with conventional new animal drugs. As part of the approval process, FDA will make clear whether edible products from particular GE animals are suitable to enter the food or feed streams. FDA will enforce these decisions with regard to GE animals the same way it enforces them with animals treated with conventional new animal drugs. At this time, based on the kinds of animals currently under development, and apart from restrictions pertaining to use in food or feed, FDA does not anticipate that it would have any reason to impose special disposal limitations on GE animals, carcasses, or parts.

Q: Does the guidance have recommendations pertaining to mandatory tracking and labeling of GE animals?

A: The guidance does not have recommendations pertaining to mandatory tracking of GE animals. Developers of GE animals must, however, have labeling accompanying the animals. The guidance recommends that the labeling describe the GE animal (e.g., common name/breed/line, genus, species, GE animal line, rDNA construct), and its intended use. Where the labeling for a GE animal contains animal care or safety information (e.g., husbandry or containment), we recommend that the labeling accompany the animal throughout all stages of its lifecycle.

Q: Does the guidance have recommendations regarding the labeling of food from GE animals? Does such food have to have additional information on the label?

A: The guidance doesn’t explicitly address labeling of food from GE animals. FDA does not require that food from GE animals be labeled to indicate that it comes from GE animals, just as food from GE plants does not have to be labeled to indicate it comes from GE plants. However, if food from a GE animal is materially different from its non-engineered counterpart (e.g., it has a different nutritional profile), in general, that change would be material information that would have to be indicated in the labeling. Food marketers may voluntarily label their foods as coming from GE or non-GE animals, as long as the labeling is truthful and not misleading.

Q: What kinds of post-approval monitoring does the guidance recommend?

A: These are similar to the post-approval requirements for sponsors of conventional new animal drugs. Developers are required to register with the agency, provide a list of all GE animals they have produced, and keep records of any additional information they develop related to the safety of the rDNA construct and the claim on which the approval was based. We recommend that sponsors work closely with the agency as approval nears to be clear on the post-approval requirements and recommendations.

We also note that as part of the approval process, the guidance recommends the development of a durability plan by sponsors, and approval of that plan by the agency. The guidance recommends that sponsors develop a plan for monitoring the genetic makeup and characteristics (i.e., the genotype and phenotype) of the GE animal to ensure that the GE animals that enter commerce over time are equivalent to the GE animals that were approved. The responsibility for the durability plan does not extend beyond the sponsors.

Q: How will FDA enforce regulatory compliance?

A: FDA will use the same enforcement mechanisms it uses with respect to conventional new animal drugs: inspections to ensure compliance with regulatory requirements and, where FDA finds a lack of compliance, the agency may take actions including seizure or obtaining a court injunction against further marketing.

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Related Issues

Q: What about ethics? Will FDA consider these in its risk management decisions?

A. The issue of ethics and biotechnology is complex. Our experience with other animal-based new technologies such as cloning and the introduction of rBST has shown that most people include animal health in their articulation of what constitutes “ethics”. We note that the new animal drug approval requirements described in the guidance require a finding of safety to animals, and so we believe that we are addressing those particular health and safety-related concerns. As for issues associated with other social concerns that may fall under the heading of “ethics”, we note that these issues are not within the scope of the guidance. We do, however, continue to participate in various venues in which these issues are discussed so that we can ensure that the discussions are based on fact and not on erroneous assumptions regarding the technology or its outcomes.

Q. How will FDA work to inform the public about new GE animals, its decisions on them, and the science behind those decisions?

A. The agency is interested in increasing the transparency of its deliberations and actions. In particular, we intend to seek input from experts and the public where there is significant public interest in an issue, and FDA believes the public may have relevant data or information to contribute. Additionally, as is the case for all NADAs, after completion of an NADA, the agency will post a summary of the information in the NADA file, including information used to assess safety (to the animal and for food, if appropriate) and in support of the claims made by the sponsor.

We have developed a number of consumer-appropriate publications to help inform consumers and other stakeholders about the technology and the agency’s regulations of these animals. These are available on the FDA website.

FDA’s new animal drug approvals (including for GE animals) are published in the Federal Register, codified in the Code of Federal Regulations, and posted on its website at Animal Drugs @ FDA. Following approvals, FDA will also provide electronic access to a summary of all information (other than confidential business or trade secret information) used in FDA’s decisions as part of the freedom of information summary routinely published upon approval.

1 The Codex Alimentarius Commission was created by the Food and Agriculture Organization and the World Health Organization of the United Nations to develop, among other things, internationally harmonized guidelines that can be used to ensure fair trade standards and coordinate food standards on an international basis.

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