The 5 Minute Veterinary Consult Pdf File

1. The 5 Minute Veterinary Consult Pdf Files

. I. GENERAL OVERVIEW On September 19-20, 2010, FDA held a meeting of the Veterinary Medicine Advisory Committee (VMAC) to consider issues regarding the safety and effectiveness of the new animal drug that is the subject of a new animal drug application (NADA) concerning AquAdvantage Salmon produced by AquaBounty Technologies, Inc. AquAdvantage Salmon are intended to grow faster than farm-raised Atlantic salmon that have not been genetically engineered. FDA simultaneously made available to the VMAC and the public an extensive “Briefing Packet” that contained a summary of the data and information on which the agency had drawn its preliminary conclusions.

This Briefing Packet, copies of the presentations made at the VMAC meeting, and a copy of the VMAC chairman’s report can be found. Interested persons were invited to present data, information, or views, orally or in writing, on issues pending before the VMAC. FDA received 322,031 written comments on the issues the VMAC considered for the AquAdvantage Salmon. Of these, 321,993 comments were form letters or general statements about GE animals. Thirty eight (38) comments were what FDA considers to be substantive because they provided specific analysis, recommendations, or opinions.

The comments were submitted by a broad range of stakeholders, including consumers, academics, trade and professional organizations, consumer and environmental groups, and other developers of GE animals. In addition, as part of the public comments on the draft Environmental Assessment (EA) and Preliminary Finding of No Significant Impact (FONSI) (Docket # 2011-N-0899 closed April 26, 2013), the agency received comments that, although substantive, were not relevant to the draft EA/preliminary FONSI, and in almost all cases, were similar to, and suitable for combining with, previously submitted comments to the VMAC. We have included those comments in the topic-based comment summaries, and addressed them immediately thereafter. Additional information regarding the NADA concerning AquAdvantage Salmon, including the final EA and FONSI and Freedom of Information (FOI) Summary, can be found at (EA); (FONSI); and (FOI Summary).

The 5 Minute Veterinary Consult Pdf Files

SUMMARY OF COMMENTS AND FDA’S RESPONSES A. Food and Food Safety i.

Food Labeling Comment Summary: Several comments addressed the issue of labeling food from AquAdvantage Salmon. Two comments requested that the Agency require food from AquAdvantage Salmon bear special labeling indicating it was developed using biotechnology, while others opined that special labeling should not be required in the absence of a nutritional difference in the food. Response: FDA held a public hearing on September 21, 2010 on labeling of food derived from AquAdvantage Salmon. The public submitted comments concerning labeling of food derived from AquAdvantage Salmon to the hearing docket. FDA is releasing separately a document that responds to these public comments.

Please refer to that document for responses to comments concerning food labeling. Food Safety Assessment Comment Summary: Several comments addressed the methods FDA used to assess the safety of food from AquAdvantage Salmon. Some comments disagreed with various aspects of FDA’s approach to the safety assessment of food from AquAdvantage Salmon or requested additional studies, analyses, or the development of a new system consisting of a public committee of food safety experts to decide the components of the food safety assessment. Others found FDA’s process for food safety assessment of AquAdvantage Salmon to be rigorous and appropriate. Response: FDA’s food safety analysis for food derived from AquAdvantage Salmon meets applicable requirements of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and FDA’s implementing regulations, and is science-based and thorough.

Accordingly, we are not requiring additional studies to determine that food from AquAdvantage Salmon is safe. Under the FD&C Act and FDA’s implementing regulations, a new animal drug cannot be approved for use in food animals unless FDA determines that the drug in or on the food, and any substance formed in or on food resulting from the use of the drug, is safe for consumption. § 360b(d); 21 CFR 514.1(b)(7). The standard that is used to determine the safety of food under the new animal drug provisions is the same as FDA’s standard for approving a food additive: reasonable certainty of no harm. See 21 U.S.C. § 360b(d)(2).

As discussed in Guidance For Industry 187: Regulation of Genetically Engineered Animals Containing Heritable Recombinant DNA Constructs (GF1 187), the food safety assessment for an NADA related to a GE animal focuses on the issue of whether food or feed derived from a GE animal is safe for humans or animals consuming edible products from the GE animal. The risks for food and feed safety can be divided into two overall categories. The first addresses whether there is any direct toxicity, including allergenicity, via food or feed consumption of the expression product of the article.

The second category addresses potential indirect toxicity associated with both the article and its expression product perturbing the physiology of the animal. Accordingly, as part of the safety determination for food from AquAdvantage Salmon, we evaluated the health of the AquAdvantage Salmon, potential toxicity to the consumer, and potential allergenicity of the expression product of the rDNA construct, Chinook salmon growth hormone, along with changes in the levels of hormones that could potentially be affected by the expression of growth hormone. We also carefully reviewed the potential for unintended effects arising from the insertion of the rDNA construct, including possible effects on the composition and allergenicity of AquAdvantage relative to appropriate comparators, including farm-raised Atlantic salmon. As we explained in GFI 187, our approach to the safety assessment of food from GE animals, including AquAdvantage Salmon, is consistent with that recommended by the Codex Alimentarius Commission, the international food safety standard setting body, in its Guideline for the Conduct of the Food Safety Assessment of Foods from Recombinant-DNA Animals (CAC/GL 68-2008) (Codex rDNA Animal Guideline).

Comment Summary: One comment stated that in the food safety studies “salmon were screened visually for general health status and traits relevant to commercial marketability,” but that not all of those fish were tested and there were no data kept on the rejected fish. Response: In a food safety study involving food animals, the general objective is to study such animals to determine whether they are suitable for consumption as food. In general, there are usually many more animals at the beginning of such studies than are selected as a sample for testing.

The reason there are more animals in these safety studies is to assure that there are sufficient animals to meet the study acceptance criteria at critical time points in the study. This is done to account for normal losses due to disease, accident, or other factors that may result in losses from the population.

Based on pre-established criteria, animals for inclusion in the study may then be selected from the larger sampling pool in a non-biased manner. Animals that are not selected are simply not used in the study, either because they fail to meet the acceptance criteria or because they are in excess of the number of animals required. In ABT’s safety study on composition, salmon were screened to determine which ones had traits, such as visual appeal, that would make them commercially marketable as food.

As a result, in the salmon food safety studies, those fish that were judged not likely to be used as food were not included in the study. This is consistent with general practices for animal food safety studies and FDA’s approach for eliminating from safety studies animals that are unlikely to be used as food. We also note that the safety study on composition was not the only data and information evaluated in our review. As explained in detail in the FOI summary, we evaluated data and information submitted by ABT, considered relevant peer-reviewed publications, and conducted our own analysis of certain data and information. Based on our review of all relevant data and information, we concluded that food from AAS is as safe as food from non-GE salmon and that there is a reasonable certainty of no harm of consumption of food from AAS.

FOI Summary at Section IX. RDNA Construct Safety Comment Summary: A few comments addressed the safety of the rDNA construct when consumed in food, and one comment raised the possibility of the transfer of DNA from the rDNA construct in AquAdvantage Salmon into the genome of gut bacteria. Response: The genetic construct that is present in AquAdvantage Salmon is composed of deoxyribonucleic acid (DNA) which is present in all living things. DNA is a normal component of food derived from animals, plants, and microorganisms, regardless of the food’s production method. Because DNA, regardless of its sequence, is present in the cells of every living organism, including every plant and animal used for food by humans or animals, and has been safely consumed in food, FDA has presumed it to be generally recognized as safe (GRAS) (FDA, Statement of Policy: Foods Derived from New Plant Varieties 57 FR 22984, 1992). Therefore, the DNA that makes up the construct in AquAdvantage Salmon poses no more food consumption risk than DNA present in other foods.

That is, the DNA present in food from AquAdvantage Salmon is no different from, and is as safe as, the DNA that we eat in other foods every day. In addition, transfer of DNA from the rDNA construct in AquAdvantage Salmon into the genome of gut bacteria would be no more or less likely to occur and would present no additional risks than the transfer of DNA from non-GE salmon into the genomes of gut bacteria.

Aquaculture Comment Summary: Two comments raised food safety concerns regarding issues sometimes associated with farm-raised salmon including the use of antibiotics in aquaculture and the accumulation of toxic substances in farm-raised salmon. Response: FDA requires that all seafood that it regulates, including all farm-raised Atlantic salmon, whether non-GE or AquAdvantage Salmon, meet all existing, applicable food safety standards, including tolerance levels for residues of animal drugs and levels of toxic substances. Composition Comment Summary: Some of the food safety comments focused on the composition of food from AquAdvantage Salmon. A subset of these cited specific differences in composition between food from AquAdvantage Salmon and Atlantic salmon (farm-raised salmon or wild and farm-raised salmon), and one comment disagreed with a specific aspect of FDA’s compositional analysis.

Others stated that food from AquAdvantage Salmon is nutritionally equivalent to non-GE Atlantic salmon. Response: FDA performed a detailed compositional analysis of ABT’s GE salmon containing the AquAdvantage rDNA construct (ABT salmon), including AquAdvantage Salmon in order to determine whether consumers eating food from AquAdvantage Salmon would be receiving the nutrients they expect from farm-raised Atlantic salmon, and whether there were any differences from farm-raised Atlantic salmon that would pose any nutritional or health risks. Because there are differences between the composition of wild-caught and farm-raised Atlantic salmon due to the differences in their diets, the appropriate comparator for composition for ABT salmon is farm-raised rather than wild-caught Atlantic salmon. Of the proximate, vitamin, mineral and amino acid analytes in the study examined for compositional analysis, only three analytes were present at levels in TX salmon (i.e., GE salmon) that were statistically significantly different from levels in non-GE control Atlantic salmon: vitamin B6 (when diploid and triploid salmon were considered together for GE and non-GE control Atlantic salmon), folic acid (when diploid salmon were compared in GE and non GE-control Atlantic salmon) and niacin (when triploid salmon were compared in GE and non-GE control Atlantic salmon). Based on all previous criteria including statistical analysis, FDA concluded that the levels of all proximate, vitamin, mineral and amino acid analytes in TX salmon except vitamin B6 are similar to levels in one or more appropriate groups of control salmon, and therefore the statistical differences are not biologically relevant.FOI summary at Section IX C 2 a.

For the statistically significant increase in the level of vitamin B6 in diploid ABT salmon (the diploid broodstock that are not to be the commercialized food product), FDA performed an additional analysis.