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It’s a food… It’s a drug… It’s
AquAdvantage Salmon!
21st Annual Tulane
Environmental Law &
Policy Summit
Ricardo Carvajal
Hyman, Phelps & McNamara, P.C.
www.hpm.com
www.fdalawblog.net
Federal Food, Drug, & Cosmetic Act
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110 year legacy
Periodic amendments
Safety
Innovation
Broad, flexible authority
Definitions are key
 201(s) - Food additive: any substance the
intended use of which can reasonably be
expected to become a component of food
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Food additives are subject to premarket approval
 Exception: the use of the substance is generally
recognized as safe (GRAS)
 409 - Whether food additive or GRAS, the use of
the substance must be “safe” = “reasonable
certainty of no harm”
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Food from GE plants
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1992 statement of policy
Nucleic acids are presumed GRAS
Intended expression products – it depends
Voluntary premarket consultation
Why not regulate food from GE animals the
same way?
Definitions are key (part 2)
 201(g) - Drug: any article (other than food)
intended to affect a structure or function of
man or animal.
 201(v) - New animal drug: not GRASE, and
not use for material extent or material time.
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Subject to premarket approval
Food from GE animals
 2009 guidance
 rDNA construct intended to affect structure or
function is a drug
 Submission and approval of a new animal
drug application (NADA) is required
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Extensive review
 Product definition
 Molecular characterization of the construct
 Molecular characterization of the GE animal
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lineage
Phenotypic characterization of the GE animal
Durability plan
Environmental and food/feed safety
Claim validation
Approval of AAS
 Investigational new animal drug status in
1995
 NADA approved on Nov. 19, 2015
 20 years, >$80 million
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Focus on safety
 FDA applied standard applicable to food
additives
There is a reasonable certainty in the minds
of competent scientists that the substance is
not harmful under the intended conditions of
use.
 It is impossible in the present state of
scientific knowledge to establish with
complete certainty the absolute
harmlessness of any substance
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Focus on safety (2)
 AAS meets the standard of identity for
Atlantic salmon
 There are no meaningful differences in food
composition
 No biologically relevant differences in total
protein, specific amino acids, vitamins,
fatty acids, ratios of fatty acids, including
omega-3 and omega-6 fatty acids
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Focus on safety (3)
 Food from AAS is as safe as food from nonGE Atlantic salmon
 There is a reasonable certainty of no harm
from consumption of food from AAS
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No significant environmental
impact
 Produced in secure facilities in Canada and
Panama
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Multiple and redundant forms of physical
containment
Possibility of escape and survival is “extremely
remote”
 Because animals are all-female and sterile,
possibility of reproduction in wild is
“extremely remote”
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Labeling
 Limited authority to compel labeling
 201(n) – label is misleading if it fails to reveal
“material” facts
 Longstanding interpretation of materiality
 Obvious and fair policy solution – “non-GMO”
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Beyond safety
 Sociopolitical views
 Economic interests
 DC playbook
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QUESTIONS?
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