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U.S. Department of Health and Human Services

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Background Document: Public Hearing on the Labeling of Food Made from the AquAdvantage Salmon

Available in PDF (63KB). 

 

August 2010

 

  1. Introduction
  2. Background
  3. FDA Meetings on the AquAdvantage Salmon
  4. Applicable Principles of Labeling Foods
  5. Questions and Answers
  6. The Part 15 Hearing

    

I. INTRODUCTION

The public is invited to participate in a hearing on the labeling (including naming) of foods made from the AquAdvantage Salmon, a genetically engineered (GE) Atlantic salmon produced by AquaBounty Technologies, Inc. 

The Food and Drug Administration (FDA or the Agency) has not made a decision on the approval of the New Animal Drug Application (NADA) related to the AquAdvantage Salmon. If FDA does not approve the NADA related to the AquAdvantage Salmon, then it will not need to consider the issue of additional labeling requirements for food from this fish. If it is approved, food made from AquAdvantage Salmon must, like all foods, bear an appropriate name and a label that is truthful and not misleading. This public hearing will assist FDA in the application of its relevant food labeling legal principles as they relate to AquAdvantage Salmon. 

The principles of food labeling are the same, whether or not a food is made from a GE source. Because this is the first time FDA is considering an application for a GE animal intended for food use, FDA is holding this public hearing to educate the public about these food labeling principles and how they apply to foods derived from GE animals, and to seek comment as FDA applies this legal framework to the labeling of food derived from AquAdvantage Salmon, in the event that the NADA is approved.

This document explains the legal principles of food labeling that are relevant for considering the labeling of food from AquAdvantage Salmon. Prior to the public hearing, specific information about AquAdvantage Salmon will be placed on the FDA website. The hearing will then provide an opportunity for the public to comment on how the food labeling principles might apply to foods made from this specific GE animal. Specifically, the Agency is seeking public comment on whether the data suggest there are any material differences—including differences in the composition of the food, or its nutritional, functional or organoleptic[1] properties—that justify naming or labeling food from this fish differently from food from its conventional counterparts.

Following the Veterinary Medicine Advisory Committee (VMAC) meeting on the AquAdvantage Salmon application, which will include discussion of safety and effectiveness issues (see Federal Register Notice - FDA-2010-N-0358) and the conclusion of this public hearing, FDA will evaluate the information and views it has received. A summary and explanation of the agency’s decision on the application and its views on food labeling will be posted on the FDA website. 

  

II. BACKGROUND

Genetic engineering refers to the use of recombinant DNA (rDNA) techniques to introduce new characteristics or traits into an organism. When scientists splice together pieces of DNA and introduce that spliced DNA segment into an organism, it’s called “rDNA technology.” The spliced piece of DNA is called the “rDNA construct.” A GE animal is one that contains an rDNA construct intended to change the animal, for example by giving the animal a new trait or characteristic. Genetic engineering has been used for approximately 20 years in the production of plants and microorganisms that make food and medicine.

FDA regulates the safety and effectiveness of the rDNA construct that is intended to change a GE animal.[2] FDA has this responsibility because that rDNA construct is an animal drug regulated by FDA under the Federal Food, Drug, and Cosmetic Act (FFDCA or the Act).[3] FDA clarified this regulatory authority in a Guidance for Industry (GFI 187).[4]

When examining the safety and effectiveness of GE animals for use as food, FDA generally will employ expert advisory committees and invite public comment to help provide information for its review. 

 

III. FDA MEETINGS ON THE AQUADVANTAGE SALMON

FDA has announced that it will be holding a public VMAC meeting regarding the NADA related to the AquAdvantage Salmon. More information on the VMAC meeting is available at http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/
VeterinaryMedicineAdvisoryCommittee/ucm201810.htm

If FDA approves the AquAdvantage Salmon NADA, the approval will include a label that identifies the rDNA construct and that must accompany the fish eggs, young fish (“fry”), and fish that are sold to growers who are bringing the fish to market size before they are sold for food. This is different from the labeling that would apply to any foods made from the AquAdvantage Salmon.

On September 21, 2010, FDA will hold a public hearing on the labeling (including naming) of food from the AquAdvantage Salmon. The public is invited to sign up in advance to present oral comments at the hearing, and will be able to submit written comments to the docket until November 22, 2010. 

At this hearing, FDA will:

  • present the relevant principles for food naming and labeling;
  • describe information made available prior to the hearing about characteristics of AquAdvantage Salmon (e.g., the chemical composition and standardized methods used to identify species in the market place) that may be relevant to food naming and labeling;[5] and
  • offer the public an opportunity to comment on the application of the relevant food labeling principles to foods that might be made from the AquAdvantage Salmon. 

 

IV.  APPLICABLE PRINCIPLES OF LABELING FOODS

Labels provide a variety of information about a food, including its name, ingredients, and nutritional profile. The following are five key principles of food labeling that are applicable to the specific issue of the labeling of foods from GE animals, such as the AquAdvantage Salmon:

First, the law prohibits food labeling that is false.[6] For example, the label for a chocolate cannot declare that the chocolate contains ingredients, such as walnuts and coconut oil, if those ingredients are not actually present in the chocolate.[7]

Second, the law prohibits food labeling that is misleading, particularly in light of material facts about the product.[8] For example, consumers could be misled about the content of a food bearing a “saturated fat free” claim if that food contains more than 0.5 grams of trans fat.[9]

Third, the law allows voluntary labeling about production methods, so long as the labeling is not false or misleading. For example, the term “fresh” can be used on foods that have not been processed (e.g., frozen or subjected to any form of thermal processing).10] Therefore, foods that have been frozen, even immediately after harvesting, cannot be labeled “fresh,” because this implies that the food has not been processed. These foods can, however, be labeled “frozen fresh” or “quickly frozen.”[11]

Fourth, the law requires that the label include a name that accurately describes the basic nature of the food.[12] In the 1992 policy on foods derived from new plant varieties and 2001 draft guidance on voluntary labeling of food from GE plants, FDA explained that name changes are appropriate when a food from a GE plant is significantly different from its traditional counterpart, such that the common or usual name no longer adequately describes the new food.[13] But changes to the name of the product are not appropriate under these laws and policies if the resulting GE food product is not materially different from its traditional counterpart (i.e., unless the GE food product differs in nutritional quality, taste, etc.).

FDA applied this reasoning when it reviewed submissions related to the FLAVR SAVR tomato. FDA concluded that the appropriate common or usual name of the product was “tomato,” because the FLAVR SAVR tomato was not significantly different from other commercial varieties of tomatoes, and there were no safety or usage concerns to which consumers of FLAVR SAVR tomatoes must be alerted by special labeling.

By contrast, when FDA evaluated GE soybean varieties that produce greater amounts of oleic acid than other soybean varieties, FDA concluded that the oil was significantly different from traditional soybean oil because it contained a much higher concentration of oleic acid, and therefore the term “soybean oil” no longer adequately described the nature of the food. Consequently, a term like "high oleic acid" would be required to appear as part of the name of the oil to describe its basic nature.[14]

Fifth, FDA cannot require additional labeling about production methods unless it is necessary to ensure that the labeling is not false or misleading.[15] Another way of stating this point is that FDA cannot require labeling based solely on differences in the production process if the resulting products are not materially different due solely to the production process. For example, recombinant Bovine Somatotropin (“rBST”) is a synthetic growth hormone that increases milk production in dairy cows.[16] Because FDA found that there was no material difference between milk from rBST-treated cows and milk from non-rBST-treated cows, FDA did not have the authority to require additional labeling of milk from rBST-treated cows.[17]

 

V. QUESTIONS AND ANSWERS

A key issue for determining whether labeling is misleading is the concept of “materiality.” For foods from the AquAdvantage Salmon, what information would be “material”?

A change in the composition of a food may or may not result in material changes in the attributes of the food.[18] FDA has required labeling in cases where the absence of “material” information leads the consumer to assume that a food, because of its similarity to another food, has nutritional, organoleptic, or functional characteristics of the food it resembles when in fact it does not. [19] For example, the labeling of margarine that has been processed in a way that results in it no longer being suitable for frying must affirmatively disclose this difference from regular margarine.[20] 

As another example, as mentioned above when FDA evaluated GE soybean varieties that produce greater amounts of oleic acid than other soybean varieties, FDA concluded that the oil was significantly different from traditional soybean oil because it contained a much higher concentration of oleic acid, and therefore the term “soybean oil” no longer adequately described the nature of the food. Consequently, a term like "high oleic acid" would be required to appear as part of the name of the oil to describe its basic nature.[21]

FDA has not found that foods from GE organisms, as a class, present different or greater safety concerns than their conventional counterparts. Nor has FDA found that, as a class, they differ materially in nutritional value, organoleptic properties, or functional characteristics.[22] Therefore, FDA does not consider the fact that a food was made using genetic engineering, in and of itself, to be a material difference. This determination has been reviewed and upheld by courts. [23]

On the other hand, if a particular GE-food is materially different from foods from its non-GE counterpart, then FDA could require that such a difference be identified in the food labeling.[24] The absence of material information in labeling would make the product misbranded. [25] Thus, for example, if an animal were genetically engineered so that food from the animal had significantly higher or lower levels of protein content, FDA would likely conclude this is a material fact. This difference in protein content levels would then have to be described in the labeling of foods made from the GE animal. 

Can FDA require additional labeling on the basis of consumer interest alone, in the absence of a material difference between the foods from a GE organism and a non-GE organism?

No. Under current law, FDA does not have the authority to require labeling based on consumer interest alone. For example, in Stauber v. Shalala, the court explained that, absent evidence of a material difference between milk from rBST-treated cows and non-rBST-treated cows, the use of consumer demand as a rationale for mandatory additional labeling would violate the law.[26]

In Alliance for Bio-Integrity v. Shalala, a coalition of groups and individuals challenged FDA’s decision not to require additional labeling of foods from GE organisms.[27] The plaintiffs alleged, among other things, that FDA’s failure to require additional labeling for foods from the GE plants was arbitrary and capricious.[28] Further, the plaintiffs claimed that the process of genetic modification was a material fact, and FDA should have considered the widespread consumer interest in having foods made from GE organisms labeled.[29]

The court denied the plaintiffs’ claims, deferring to FDA’s determination that, in general, genetic engineering does not materially alter foods.[30] Further, the court held that consumer demand alone was not sufficient to require additional labeling of foods made from GE organisms.[31] The court explained that only when “materiality has been established may the FDA consider consumer opinion to determine whether a label is required to disclose a material fact.” The court held that “[g]iven these facts, the FDA lacks a basis upon which it can legally mandate labeling, regardless of the level of consumer demand.”[32] 

Even though FDA may not require it, can a producer or manufacturer put additional information on the label about whether the food is or is not made from a GE organism?

Yes. As with all foods, producers and manufacturers can include additional information on the labeling of their products, so long as the information is truthful and not misleading. A manufacturer or producer should be able to substantiate that its claims are truthful and not misleading.

 

VI.  THE PART 15 HEARING

At the Part 15 hearing, FDA will seek public comment on the application of these principles of food labeling to food from the AquAdvantage Salmon. To facilitate public comment, specific technical information about the AquAdvantage Salmon will be posted on the FDA website approximately 2 weeks (but no later than 2 business days) prior to the public hearing. 

At the public hearing, FDA will be inviting the public to share its views on: 

  1. Which facts about the AquAdvantage Salmon seem most pertinent for FDA’s consideration of whether there are any “material” differences between foods from this salmon and foods from other Atlantic salmon. (Keep in mind that the use of genetic engineering does not, in and of itself, constitute a “material” difference under the law.)
  2. If FDA determined there are ‘‘material’’ differences, how would that difference be described on a food label in a way that is truthful and nonmisleading. (Keep in mind that it is the difference in composition, or in functional, organoleptic or other material properties that must be described,not the underlying production process.)

In the event that the AquAdvantage Salmon NADA is approved, FDA will evaluate all relevant data and information available to the Agency within the context of FDA’s legal authority relating to food labeling. FDA will then apply the food labeling principles explained above to determine whether food from AquAdvantage Salmon requires additional labeling. 

For more information on the public hearing, including registration information and requests to make an oral presentation at the hearing see FDA's notice of public hearing available at: http://edocket.access.gpo.gov/2010/2010-21243.htm.


[1] Organoleptic properties are those that stimulate the sensory organs, such as texture or aroma.
[2] As a shorthand in this document, we sometimes refer to regulation or approval of the construct as regulation or approval of the GE animal or regulation or approval of the AquAdvantage Salmon.
[3] The FFDCA defines the term “drug” as an “article (other than food) intended to affect the structure or any function of the body of man or other animals.” 21 U.S.C. § 321(g)(1)(C). 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.
[5] FDA has developed a Regulatory Fish Encyclopedia (RFE) that assists with the accurate identification of fish species to help federal, state, and local officials and purchasers of seafood identify species. It includes such characteristics as overall appearance of the fish (e.g., shape, size) as well as species-specific biochemical characteristics. For the case of AquAdvantage Salmon, FDA has performed a test called protein isoelectric focusing which is used for the identification of species of fish. We sometimes refer to this test as "molecular footprinting."  
[6] Under § 403(a)(1) of the FFDCA [21 U.S.C. § 343(a)(1)], a food is misbranded if “its labeling is false or misleading in any particular.” 
[8] Section 201(n) of the FFDCA [21 U.S.C. § 321(n)] provides information on how labeling can be misleading. It states that labeling is misleading if it fails to reveal facts that are (1) material in light of representations made or suggested in the labeling, or (2) material with respect to consequences that may result from the use of the food to which the labeling or advertising relates under the conditions of use prescribed in the labeling or under such conditions of use as are customary or usual.
[9] See 21 C.F.R. 101.62(c) (requiring that in order for a food to be labeled as “saturated fat free,” the food must contain less than 0.5 grams of saturated fat and less than 0.5 grams of trans fat per reference amount customarily consumed); 58 Fed. Reg. 2332, 2340 (Jan. 6, 1993).
[10] See 21 C.F.R. § 101.95(a) (“The term ‘fresh,” when used . . . in a manner that suggests or implies that the food is unprocessed, means that the food is in its raw state and has not been frozen or subjected to any form of thermal processing or any other form of preservation . . . .”).
[11] See 21 C.F.R. §101.95(b) (“The terms ‘fresh frozen’ and ‘frozen fresh’ . . . mean that the food was quickly frozen while still fresh (i.e., the food had been recently harvested when frozen.”).
[12] 21 U.S.C § 343(i) (requiring that a food label must bear the common or usual name of the food); 21 C.F.R. § 102.5(a) (“The common or usual name of a food . . . shall accurately identify or describe, in as simple and direct terms as possible, the basic nature of the food . . . .”).
[13] 57 Fed. Reg. 22984 (May 29, 1992); accord 66 Fed. Reg. 4839 (Jan. 18, 2001).
[15] See e.g., 72 Fed. Reg. 16291, 16294 (Apr. 4, 2007). As noted previously, voluntary labeling about production methods is allowed, provided the label is not false, is not misleading, and its claims can be substantiated.
[16] See e.g., 59 Fed. Reg. 6279 (Feb. 10, 1994). 
[17] Stauber v. Shalala, 895 F. Supp. 1178, 1193 (W.D. Wis. 1995).
[18] See e.g., 72 Fed. Reg. 16291, 16293 (Apr. 4, 2007).
[19] See e.g., 72 Fed. Reg. 16291, 16293 (Apr. 4, 2007).
[20] Id.
[22] 57 Fed. Reg. 22991 (May 29, 1992); 66 Fed. Reg. 4839 (Jan. 18, 2001).
[23] See Alliance for Bio-Integrity v. Shalala, 116 F. Supp. 2d 166, 178–79 (D.D.C. 2000) (finding that FDA’s determination that genetic engineering, alone, is not a material fact that warrants labeling was entitled to deference); Stauber, 895 F. Supp. at 1193 (upholding FDA’s decision to not require labeling of milk from rBST-treated cows because plaintiffs failed to show any evidence demonstrating a material difference between milk from rBST-treated cows and non-rBST-treated cows).
[24] See 21 U.S.C. §§ 321(n); 343(a)(1).
[25] Id.
[26] 895 F. Supp. at 1193.
[27] 116 F. Supp. 2d 166.
[28] Id. at 170.
[29] Id. at 178–79.
[30] Id. at 179.
[31] Id.
[32] Id.