Contains Nonbinding Recommendations 
Draft-Not for Implementation 
 
Voluntary Labeling Indicating Whether 
Food Has or Has Not Been Derived From 
Genetically Engineered Atlantic Salmon:  
Guidance for Industry 
 
 
Draft Guidance 
This guidance is being distributed for comment purposes only. 
 
Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure 
that FDA considers your comment on this draft guidance before we begin work on the final 
version of the guidance, submit either electronic or written comments on the draft guidance 
within 60 days of publication in the Federal Register of the notice announcing the availability of 
the draft guidance.  Submit electronic comments to https://www.regulations.gov.  Submit written 
comments to the Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 
Fishers Lane, Rm. 1061, Rockville, MD 20852.  All comments should be identified with the 
docket number [FDA-2015-D-4272] listed in the notice of availability that publishes in the 
Federal Register.  
 
For questions regarding this draft document contact the Center for Food Safety and Applied 
Nutrition (CFSAN) at 240-402-2371. 
 
 
 
U.S. Department of Health and Human Services 
Food and Drug Administration 
Center for Food Safety and Applied Nutrition 
Center for Veterinary Medicine 
 
Issued November 2015 
Revised March 2019 
    
  Contains Nonbinding Recommendations 
Draft-Not for Implementation 
 
Table of Contents 
 
I.   Introduction
   
II.   Background
   
III.   Guidance
   
A. General principles 
B.  Statements about food products or food ingredients derived from Atlantic salmon or 
other salmon species that have not been genetically engineered 
C.  Statements about Atlantic salmon, or food products or food ingredients derived from 
Atlantic salmon that has been genetically engineered 
D.  Substantiation of labeling statements 
IV.  References
   
 
 
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Voluntary Labeling Indicating Whether 
 
Food Has or Has Not Been Derived From 
Genetically Engineered Atlantic Salmon:  
1
Guidance for Industry  
 
 
This draft guidance, when finalized, will represent the current thinking of the Food and Drug 
Administration (FDA or we) on this topic.  It does not establish any rights for any person and is 
not binding on FDA or the public.  You can use an alternative approach if it satisfies the 
requirements of the applicable statutes and regulations.  To discuss an alternative approach, 
contact the FDA staff responsible for this guidance as listed on the title page.  
 
 
I.    Introduction 
 
This document provides guidance intended to assist food manufacturers that wish to voluntarily 
label their food products or ingredients (for humans or animals) derived from Atlantic salmon as 
either containing or not containing products from genetically engineered (GE) Atlantic salmon.2  
This document also provides guidance on voluntary statements that may be appropriate for 
species of salmon that have no GE counterparts.  FDAs main concern within the context of this 
guidance is that such voluntary labeling be truthful and not misleading.  
 
                                                 
1 This guidance has been prepared by the Office of Nutrition and Food Labeling in the Center for Food Safety and 
Applied Nutrition and the Office of the Director in the Center for Veterinary Medicine at the U.S. Food and Drug 
Administration.   
2 In July 2016, the National Bioengineered Food Disclosure Standard (NBFDS), PL 114-216, was signed into law.  
This law amended the Agricultural Marketing Act and charged the U.S. Department of Agricultures (USDA) 
Agricultural Marketing Service (AMS) with developing a national mandatory standard for disclosing the presence of 
bioengineered material in human food.  The term bioengineered as defined in that law includes products that are 
GE.  The law primarily applies to human food derived from plants; however, it does apply to some animal-derived 
foods, including salmon.  As a result, Federal law now requires that human food that is derived from or contains GE 
Atlantic salmon must bear a disclosure on the label that conforms to the national standard, as further defined through 
final USDA regulations.  Therefore, FDA no longer has authority over voluntary labeling to indicate the presence of 
GE content in human foods, including salmon.  FDA retains jurisdiction over labeling statements to indicate the 
absence of GE content in human food.  The NBFDS does not apply to animal food.  
In light of the NBFDS and its implementing regulations issued on December 20, 2018, FDA is reviewing this draft 
guidance to consider what additional or new recommendations may be needed for the kinds of products or 
statements, including claims of non-GE content, that are not covered by the NBFDS.   
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FDAs guidance documents, including this guidance, do not establish legally enforceable 
responsibilities.  Instead, guidances describe FDAs current thinking on a topic and should be 
viewed only as recommendations, unless specific regulatory or statutory requirements are cited. 
The use of the word should in FDA guidances means that something is suggested or 
recommended, but not required. 
 
In this guidance, we use the terms bioengineering, bioengineered, and genetic engineering 
to describe the use of modern biotechnology.  Modern biotechnology means the application of in 
vitro nucleic acid techniques, including recombinant deoxyribonucleic acid (DNA) and direct 
injection of nucleic acid into cells or organelles, or fusion of cells beyond the taxonomic family, 
that overcome natural physiological reproductive or recombinant barriers and that are not 
techniques used in traditional breeding and selection (Ref. 1).  The term modern biotechnology 
may alternatively be described as recombinant DNA (rDNA) technology, genetic 
engineering, or bioengineering.  These terms are often used interchangeably by industry, 
federal agencies, international bodies, and other interested stakeholders and are used in this 
guidance to refer to foods developed using modern biotechnology.  For the purpose of this 
guidance, FDA will primarily use the term genetic engineering or GE to describe the use of 
modern biotechnology in Atlantic salmon. FDA considers the term genetic modification to be 
a much broader term that encompasses other means of altering the genome of an organism 
including selective breeding, and lab-based in vitro methods. Genetic engineering is thus a subset 
of genetic modification3. 
 
With regard to animals, FDA regulates GE animals under the new animal drug provisions of the 
Federal Food, Drug, and Cosmetic Act (the FD&C Act).  We described our process and authority 
for regulating GE animals in a 2009 Guidance for Industry, 187, Regulation of Genetically 
Engineered Animals Containing Heritable Recombinant DNA Constructs (GFI 187).  (Ref. 2).   
 
As explained in GFI 187, in general, a new animal drug must be the subject of an approved new 
animal drug application (NADA) unless it is the subject of an investigational exemption or is 
used in conformance with regulations promulgated under sections 512(a)(4) or (a)(5) of the 
FD&C Act (21 U.S.C. 360b(a)(4) or (a)(5)).  
 
On November 19, 2015, FDA approved a new animal drug application (NADA) for an rDNA 
construct in a line of farm-raised Atlantic salmon known as AquAdvantage Salmon.4  This is 
FDAs first approval of a NADA related to a GE animal intended for use as food.  
AquAdvantage Salmon is genetically engineered to reach market size in a shorter period of time 
than do non-GE farm-raised Atlantic salmon.  Because section 201(f)(1) of the FD&C Act (21 
                                                 
3 For a more detailed discussion, please see 
http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/ucm059098.htm  
4 The NADA is for approval of the integrated -form of the opAFP-GHc2 gene construct at the -locus in the EO-
1 line of Atlantic salmon under the conditions of use specified in the application, however, for ease of reference, 
this document refers to the application as being for approval of the AquAdvantage Salmon. 
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U.S.C. 321(f)) defines food as articles used for food or drink for man or other animals, the 
food from GE and other Atlantic salmon addressed in this guidance include Atlantic salmon (and 
the products derived from Atlantic salmon) used as food for humans as well as for animals. 
 
For simplicity we use the term genetically engineered Atlantic salmon in this guidance to refer 
to food products that are derived from genetically engineered Atlantic salmon, as well as to the 
GE Atlantic salmon itself.5   
 
II.    Background 
 
The FD&C Act prohibits the introduction or delivery for introduction into interstate commerce 
of any food that is misbranded.  21 U.S.C.  331(a).  Under section 403(a)(1) of the FD&C Act, 
a food is misbranded if its labeling is false or misleading in any particular.  21 U.S.C. 
 343(a)(1).  Section 201(n) of the FD&C Act (21 U.S.C. 321(n)) provides that labeling is 
misleading if, among other things, it fails to reveal facts that are material in light of 
representations made or suggested in the labeling, or material with respect to consequences that 
may result from the use of the food to which the labeling relates under the conditions of use 
prescribed in the labeling, or under such conditions of use as are customary or usual.  21 U.S.C. 
 321(n).   
 
The FD&C Act does not define the term material within the context of section 201(n) of the 
FD&C Act.  Historically, FDA has interpreted the term, within the context of food, to mean 
information about the attributes of the food itself.  For example, FDA has required additional 
labeling in cases where the absence of such material information may:  (1) pose special health 
risks (e.g., a warning statement on protein products used in very low calorie diets (21 CFR 
101.17(d)) (Ref. 3), or a caution statement not to feed animal food products that contain animal-
derived protein to cattle or other ruminants (21 CFR 589.2000(c)(1)(i)) (Ref. 4)); (2) mislead the 
consumer in light of other statements made on the label (e.g., a requirement for quantitative 
nutrient information when certain nutrient content claims are made about a product (21 CFR 
101.13(j)) (Ref. 5)); or (3) in cases where a consumer may assume that a food, because of its 
similarity to another food, has nutritional, functional, or other essential characteristics of the food 
it resembles when in fact it does not (e.g., a statement that reduced fat margarine is not suitable 
for frying (21 CFR 101.13(d)(1)) (Ref. 6)).  Further, section 403(i) of the FD&C Act and FDA 
regulations require that each food bear a common or usual name or, in the absence of such a 
name, an appropriately descriptive term (21 U.S.C.  343(i); 21 CFR 101.3, 501.3).   
 
In a 1992 Statement of Policy: Foods Derived from New Plant Varieties (1992 Policy) (Ref. 
7), FDA explained its interpretation of the FD&C Act with respect to foods from new plant 
varieties, including varieties developed using bioengineering.  In the 1992 Policy, FDA stated 
                                                 
5 Technically, it is the animal that is GE (an Atlantic salmon in this case) rather than the food derived from the 
animal (i.e., the genetic engineering is directed at the animal and not the food). 
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that it is not aware of any information showing that bioengineered foods differ from other foods 
in any meaningful or uniform way, or that, as a class, foods developed by the new techniques 
present any different or greater safety concern than foods developed by non-GE plant breeding 
(Ref.7).  Further, FDA concluded that the method of development of a new plant variety 
(including the use of new techniques such as rDNA technology) is generally not material 
information within the meaning of section 201(n) of the FD&C Act and would not usually be 
required to be disclosed in labeling for the food.  This determination was reviewed and upheld by 
the court in Alliance for Bio-Integrity v. Shalala, 116 F. Supp. 2d 166, 17879 (D.D.C. 2000) 
(finding that FDAs determination that genetic engineering, alone, is not a material fact that 
warrants food labeling was entitled to deference) (Ref 8).  Labeling provided by manufacturers 
on a wholly voluntary basis regarding whether a food was or was not bioengineered as described 
in this guidance is acceptable to FDA, provided that such labeling is truthful and not misleading.  
Some consumers are interested in the information provided in such labeling 
 
Furthermore, on January 18, 2001, FDA issued a draft guidance for industry entitled, Voluntary 
Labeling Indicating Whether Foods Have or Have Not Been Developed Using Bioengineering.  
In this document, FDA noted we were not aware of any data or information that would form a 
basis for concluding that use of bioengineering alone is a material fact that must be disclosed 
under sections 403(a) and 201(n) of the FD&C Act.  On November 19, 2015, we published a 
final version of this guidance (http://www.fda.gov/foodguidances).  For many years, FDA has 
consistently noted that the method of development of a new plant variety is generally not 
material information within the meaning of section 201(n) of the FD&C Act and would not 
usually be required to be disclosed in the labeling for the food.  
 
FDA similarly noted in GFI 187 that labeling of food from GE animals would be subject to the 
same requirements as food from non-GE animals, and that as with food from GE plants, the fact 
that the animal from which food was obtained was genetically engineered would not be material 
information with respect to labeling.  However, if food from a GE animal is significantly 
different from that of its non-GE counterpart (for example if it has a different nutritional 
property) in general that difference would be material information that would have to be revealed 
in labeling.   
 
On September 21, 2010, FDA held a public hearing regarding the labeling of food derived from 
AquAdvantage Salmon (Ref. 9).  At the hearing, FDA explained relevant legal principles for 
food labeling and asked for information and views on the application of these principles to the 
labeling of food derived from AquAdvantage Salmon.  FDA asked the public to comment on two 
questions: (1) which facts about the AquAdvantage Salmon seem most pertinent for FDAs 
consideration of whether there are any material differences between foods from this salmon 
and foods from other Atlantic salmon and (2) if FDA determined there are material 
differences, how would those differences be described on a food label in a way that is truthful 
and non-misleading.  See 75 FR 52602.  We received more than 30,000 written comments in 
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response to the public hearing; many of these comments requested mandatory labeling of GE 
salmon should FDA approve it.   
 
After reviewing data and information submitted in response to the public hearing, we did not find 
any data or information showing that AquAdvantage Salmon is materially different from other 
Atlantic salmon in a manner that would require additional labeling in accordance with sections 
403(a) and 201(n) of the FD&C Act.  
 
Based on our assessments of food derived from the AquAdvantage Salmon, we have determined 
that the term Atlantic salmon is the appropriate common or usual name for such food within 
the meaning of section 403(i) of the FD&C Act because AquAdvantage Salmon meets FDAs 
regulatory standard for Atlantic salmon (Ref. 10) and the composition and basic nature of food 
from AquAdvantage Salmon does not significantly differ from its non-GE counterpartnon-GE 
farm-raised Atlantic salmon.  In addition, we have determined that food derived from 
AquAdvantage Salmon is as safe and nutritious as food from other farm-raised Atlantic salmon. 
For these reasons, we have concluded that there is no material difference between food derived 
from AquAdvantage Salmon and food derived from other non-GE, farm-raised Atlantic salmon 
that is required to be disclosed in the labeling of food derived from AquAdvantage Salmon under 
the relevant provisions of the FD&C Act, as explained above. See 21 U.S.C. 321(n) & 343(a).  
 
Nonetheless, we recognize that some consumers are interested in knowing whether a food is 
derived from genetically engineered Atlantic salmon, and some manufacturers may want to 
respond to this consumer interest.  FDA supports voluntary labeling and is providing this 
guidance to assist manufacturers that wish to voluntarily label their foods as being made with 
Atlantic salmon or ingredients derived from Atlantic salmon that has or has not been genetically 
engineered.   
 
III.   Guidance 
 
A. General principles 
 
In determining whether a food is misbranded, FDA generally reviews labeling statements, 
including statements about the use of foods or ingredients derived from plants, animals, or 
microorganisms that have been produced through modern biotechnology, under sections 403 and 
201(n) of the FD&C Act, and if applicable, other sections of the FD&C Act.  A food is 
misbranded under section 403(a)(1) of the FD&C Act if its label or labeling is false or 
misleading in any particular.  For example, the label on a package of crab cakes cannot declare 
that the crab cakes contain ingredients, such as celery and onions, if those ingredients are not 
actually present in the crab cakes.   
 
Under section 201(n) of the FD&C Act, both the presence and the absence of information are 
relevant to whether labeling is misleading.  Put another way, food labeling may be misleading if 
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it makes or suggests certain representations, or if it fails to disclose facts that are material in light 
of representations made or suggested in the labeling, or facts that are material with respect to the 
consequences that may result from use of the food to which the labeling relates.  In determining 
whether a labeling statement about a food is misleading under sections 201(n) and 403(a)(1) of 
the FD&C Act, FDA takes into account all labeling for that food, including the label of the food 
itself or any of its containers or wrappers and other information accompanying the food, such as 
labeling for the food that is on the internet.     
 
In addition, section 403(i) of the FD&C Act and FDA regulation require that a food bear a 
common or usual name or, in the absence of such a name, an appropriately descriptive term (21 
U.S.C.  343(i); 21 CFR 101.3, 501.3).   
 
These labeling requirements apply to foods generally, including food from GE animals or plants.  
Accordingly, if a GE derived food presents characteristics that are materially different from those 
of comparable foods (e.g., differences in the basic nature of the food, material differences in the 
consequences of use, material differences in the nutritional properties, or contained any allergens 
that the consumer would not expect to be in the food), then additional labeling would be 
required.  Thus, with regard to food from Atlantic salmon: 
 
  If food derived from genetically engineered Atlantic salmon were significantly different 
from its non-GE counterpart (i.e., non-GE farm-raised Atlantic salmon) such that the 
common or usual name no longer adequately described the new food, the name would 
have to be changed to a term that adequately and sufficiently described the new food.  
See 21 CFR Parts 101.3, 201.3; and 102.5, 502.5.    
 
  If food derived from genetically engineered Atlantic salmon differed from its non-GE 
counterpart in terms of how the food is used or with respect to the consequences of its 
use, a statement would have to be made in the labeling to describe the difference(s) in use 
or the consequences of its use. 
 
  If food derived from genetically engineered Atlantic salmon had a significantly different 
nutritional property compared to its non-GE counterpart, the labeling of that food would 
have to describe such difference. 
 
  If food derived from genetically engineered Atlantic salmon contained an allergen that 
consumers would not expect to be present, the presence of that allergen would have to be 
disclosed on the food label. 
 
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B.  Statements about food products or food ingredients derived from Atlantic salmon or 
other salmon species that have not been genetically engineered  
 
Food manufacturers may label food products or food ingredients as being derived from Atlantic 
salmon that have not been genetically engineered, as long as such information is truthful and not 
misleading.  For food products or food ingredients derived from Atlantic salmon that was not 
genetically engineered, examples of statements that manufacturers may voluntarily use include: 
 
  Not genetically engineered. 
  Not genetically modified through the use of modern biotechnology.  
  We do not use Atlantic salmon produced using modern biotechnology. 
 
Other terms are sometimes used by manufacturers in food labeling regarding whether a food was 
not derived from genetic engineering, including not genetically modified and claims using the 
acronym GMO (genetically modified organism). In light of potential confusion regarding the 
meaning of the acronym GMO, FDA encourages manufacturers to use terms such as not 
bioengineered, not genetically engineered, and not genetically modified through the use of 
modern biotechnology.  However, FDA does not intend to take enforcement action against a 
label using the acronym GMO in a statement indicating that the product (or an ingredient) was 
not produced through the use of modern biotechnology, as long as the food is, in fact, not derived 
from a genetically engineered source and the foods labeling is not otherwise false or misleading, 
as further discussed in this guidance.  Similarly, we do not intend to take enforcement action 
against a label using the acronym GMO in a statement indicating that the product (or an 
ingredient) was produced through the use of modern biotechnology, as long as the statement was 
true and the foods labeling is not otherwise false or misleading. 
 
As noted above, under section 403(a)(1) of the FD&C Act, a food is misbranded if its labeling is 
false or misleading in any particular.  Both the presence and absence of information on labeling 
can be misleading.  Regarding the absence of information, section 201(n) of the FD&C Act 
provides in relevant part that labeling is misleading if it fails to reveal facts that are material in 
light of representations made or suggested in the labeling, or material with respect to 
consequences that may result from use of the food to which the labeling relates under the 
conditions of use prescribed in the labeling, or under conditions of use as are customary or usual.   
 
An example of a statement in food labeling that may be false or misleading could be the 
statement None of the ingredients in this food is genetically engineered on a food where some 
of the ingredients are incapable of being produced through genetic engineering (e.g., salt).  It 
may be necessary to carefully qualify the statement where modern biotechnology is not used to 
produce a particular ingredient or type of food.   
 
Further, a statement may be false or misleading if, when considered in the context of the entire 
label or labeling (as noted in Section IIIA. above), it suggests or implies that a food product or 
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ingredient is safer, more nutritious, or otherwise has different attributes than other comparable 
foods because the food was not genetically engineered.  For example, the labeling of a box of 
frozen Atlantic salmon croquettes that states that they were not produced through modern 
biotechnology could be misleading if, in addition to this statement, the labeling contains 
statements or vignettes that suggest or imply that, as a result of not being produced through 
modern biotechnology, such food is safer, more nutritious, or has different attributes than other 
foods solely because the food was not produced using modern biotechnology.  
 
We recognize that consumers may not distinguish among different types of salmon.  Since the 
AquAdvantage Salmon is a farm-raised Atlantic salmon, its only direct non-GE counterpart is 
farm-raised Atlantic salmon that is not genetically engineered.  If sellers of other types of 
salmon, such as Sockeye salmon, want to assist consumers in avoiding confusion about the 
limited scope of fish products on the market that are genetically engineered, they may wish to 
label their products in a way that makes this point clear, such as Not genetically engineered.  No 
Sockeye salmon is genetically engineered.6 
 
C.  Statements about Atlantic salmon, or food products or food ingredients derived from 
Atlantic salmon that has been genetically engineered 
 
The following are examples of some voluntary statements that food manufacturers might make 
in the labeling of food products or food ingredients derived from AquAdvantage Salmon. 
 
  Genetically engineered or  
  This salmon patty was made from Atlantic salmon produced using modern 
biotechnology. 
 
These kinds of simple statements abovethat Atlantic salmon was developed using genetic 
engineeringare not likely to be misleading.  Similarly, the following statement explaining why 
the salmon was genetically engineered is not likely to be misleading. 
 
  This Atlantic salmon was genetically engineered so it can reach market weight faster 
than its non-genetically engineered counterpart.  
 
D.  Substantiation of labeling statements  
 
A manufacturer that claims that food products or food ingredients derived from Atlantic salmon 
that either has or has not been genetically engineered should substantiate that the claim is truthful 
                                                 
6 The labeling of any food as having not been produced through the use of genetic engineering could be misleading 
if, in addition to this statement, the labeling contains statements or vignettes that suggest or imply that, as a result of 
not being produced through modern biotechnology, the food is safer, more nutritious, or has different attributes than 
other foods solely because the food was not produced using modern biotechnology. 
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and not misleading.  Documentation of handling practices and procedures may be used to 
substantiate a claim.  Manufacturers should consider appropriate recordkeeping to document 
whether food comes from Atlantic salmon that has or has not been produced using genetic 
engineering.  This could include documentation of valid segregation procedures sufficient to 
ensure that its labeling is not false or misleading.  
 
For food products or food ingredients derived from salmon other than Atlantic salmon, 
substantiation that the products or ingredients have not been genetically engineered is not 
necessary at this time because FDA has not approved an application concerning a GE salmon 
other than AquAdvantage Salmon. Consequently, other GE fish are not available on the market.  
 
IV.   References 
 
The following references marked with an asterisk (*) are on display in the Dockets Management 
Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 
20852, and are available for viewing by interested persons between 9 a.m. and 4 p.m., Monday 
through Friday; they also are available electronically at https://www.regulations.gov.  References 
without asterisks are not on public display at https://www.regulations.gov because they have 
copyright restriction.  Some may be available at the website address, if listed.  References 
without asterisks are available for viewing only at the Dockets Management Staff.  FDA has 
verified the website addresses, as of March 6, 2019, but websites are subject to change over time. 
 
1. Codex Alimentarius Commission. 2003. Amendments in 2008, 2011. "Principles for the Risk 
Analysis of Foods Derived From Modern Biotechnology CAC/GL 44-2003"   
http://www.codexalimentarius.net/download/standards/10007/CXG_044e.pdf.   
 
2. Guidance for Industry, Regulation of Genetically Engineered Animals Containing Heritable 
Recombinant DNA Constructs, FDA, Center for Veterinary Medicine, Final Guidance, January 
15, 2009. 
http://www.fda.gov/downloads/AnimalVeterinary/GuidanceComplianceEnforcement/Guidancef
orIndustry/UCM113903.pdf.* 
 
3. Food and Drug Administration. 1984. "Food Labeling: Protein Products; Warning Labeling" 
Federal Register, Vol. 49, pp. 13679 at 13685, April 6, 1984.*   
 
4. Food and Drug Administration. 1997. "Substances Prohibited From Use in Animal Food or 
Feed; Animal Proteins Prohibited in Ruminant Feed" Federal Register Vol. 62, pp. 30936 at 
30977, June 5, 1997.*   
 
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5. Food and Drug Administration. 1993. "Food Labeling:  Nutrient Content Claims, General 
Principles, Petitions, Definition of Terms; Definitions of Nutrient Content Claims for Fat, Fatty 
Acid, and Cholesterol Content of Food" Federal Register Vol. 58, pp. 2302 at 2365, January 6, 
1993.* 
 
6. Food and Drug Administration. 1993.  Food Standards:  Requirements for Foods Named by 
Use of a Nutrient Content Claim and a Standardized Term Federal Register. Vol. 58, pp. 2431 
at 2437, January 6, 1993.* 
 
7. Food and Drug Administration. 1992. "Statement of Policy: Foods Derived From New Plant 
Varieties; Notice" Federal Register. Vol. 57, May 29, 1992, pp. 22984-23005.* 
 
8. See Alliance for Bio-Integrity v. Shalala, 116 F. Supp. 2d 166, 17879 (D.D.C. 2000). 
 
9. Food and Drug Administration.  2010. Food Labeling; Labeling of Food Made From 
AquAdvantage Salmon; Public Hearing; Request for Comments Federal Register. Vol. 75, pp. 
52602 to 52605, August 26, 2010.*  
 
10. Food and Drug Administration.  Revised 2015.  Regulatory Fish Encyclopedia 
http://www.fda.gov/food/foodscienceresearch/rfe/default.htm.* 
 
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