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ANEXO
A POSIÇÃO BRASILEIRA PARA A 3ª REUNIÃO DO
GRUPO INTERGOVERNAMENTAL AD HOC DO CODEX SOBRE ALIMENTOS DERIVADOS DA BIOTECNOLOGIA
TEMA
5 - Resposta a CL 2001/38 - FBT
Comments
of the Brazilian Delegation to CL 2001/38 - FBT
ANNEX
I, II and III of ALINORM 01/34A
1
- Annex I
Assessment
of Possible Allergenicity (Proteins)
Section
1 - Introduction
1.
We suggest to clarify better the definition for "newly
expressed protein", due to the fact that the conjugated
proteins, such as glycoproteins and phosphoglycoproteins, have been
identified and can act like potential allergens.
"According
to Steve L. Taylor 1 "there is the existing possibility that
other components of the food that can act as haptens".
1see
paper Topic 1: Overview of Current Approach have determines the
Allergenicity of Genetically Modified Foods (Steve L. Taylor) Joint
FAO/WHO Expert Consultation on Foods derived from Biotechnology.
2
- According to Stryer, 1995, proteins, poliosides and nucleic acids
are, in general, effective antigens. In their majority, the small
strange molecules do not stimulate antibody formation. However, they
can promote the formation of specific antibody if they are linked to
macromolecules. The macromolecule is then the carreator of the linked
chemical group, that is called determinant haptenic. The strange and
small molecule is called hapten. The antibodies induced by haptens
linked also react with haptens not linked. These organic, natural or
synthetical molecules of low molecular mass (lower than 1 KDa),
penetrate in the epidermis, they conjugate with proteins of the body
and thus are carried. The joint hapten-carreator is called conjugated.
²Biochemistry.
Lubert Stryer. Eds. W. H. Freedman and Company, New York, New York
and Basingstoke, 1995.
Section
2 - Assessment Strategy
3.
Include the phrase "and heat stability and/or, acid and
enzymatic treatment" after "enzymatic degradation".
-
Relative resistance to enzymatic and/or heat and acid treatment are
physicochemical characteristics of known food allergens and should be
considered in the Assessment Strategy.
-
see: Ricki M. Helm. Topic 5: Stability of Known Allergens (Digestive
and Heat Stability),. Joint FAO/WHO Expert Consultation on Foods
Derived from Biotechnology and;
-
Kuiper, H.A., Kleter, G.A., Noteborn, H.P.J. and Kok, E.J.
"Assessment of the safety issues related to genetically modified
foods". The Plant Journal, 27 (6): 503-528, 2001.
Section
3 - Initial Assessment
Section
3.1 - Source of Protein
6.
Include "such as physicochemical and immunological
properties" after "structural characteristics and amino
acid sequence" (...).
-
There is a relationship among the physicochemical properties and the
stability and the size of the protein;
-
The immunological properties include immunogenicity and cross-reactivity.
See:
Topic 3: Allergen Databases/Class of protein/Allergen function (Rob
Aalberse) Joint FAO/WHO Expert Consultation on Foods derived from Biotechnology.
7.
We agree with the previous recommendation proposed to Metcalfe et
al. (1996); Hileman et al, (2001)( in press) to maintain that any
match of 8 contiguous identical amino acids is a conservative yet
appropriate criteria for such searches, until better understanding.
According to Hileman et al, (2001), in a study reported with corn, it
concludes that the analysis criterion for 6 identical amino acids
would lead to the identification of 84 % of all the corn proteins as
allergenic, a gross over-estimation. The results obtained by
alignment by FASTA indicated that just 8 of the 50 existing proteins
probably are homologous to one or more allergenic proteins. The data
supports recommendation that any match of 8 contiguous identical
amino acids is a conservative yet appropriate criterion for such
searches. The additional FASTA search and the information regarding
the probability of homology or the > 35% identify in any segment
of 80 or more amino acids (FAO/WHO 2001).
-
Metcalfe, D.D., J.D. Astwood, R. Townsend, H.A. Sampson, S.L. Taylor
and R.L. Fuchs. "Assessment of the allergenic potential of foods
from genetically engineered crop plants". Crit Rev Food Sci Nut,
36(S):S165-186, 1996.
-
Hileman, R.E., Silvanovich, A., Astwood, J.D., Hefle, S.L. "A
bioinformatics approach to the assessment of the allergenicity of
foods produced through agricultural biotechnology. Adv. Food Nutr.
Res., 2001 (In press).
Section
3.3 - Pepsin Resistance
12.
Add to the item 12, after the last paragraph: "Simulated
Intestinal Fluid assays (SIF) 2 with trypsin, chymotrypsin,
carboxipeptidase enzymes should also be carried out.
Assessment
of in vitro digestion with f others enzymes of the digestive tract
has been described in USP1 (1990) and carried out by Fuchs et al 2,
(1993) and Harrison et al3, (1996).
1
USP . The United States: Pharmacopeia, Vol XXII, NFXVII. United
States Pharmacopeial Convention, Inc., Rockville, MD, 1990.
2
Fuchs, R. L., Ream, J. E., Hammond, B. G., Naylor, M. W.,
Leimgruber, R.M., & Berberich, S. A. Safety assessment of
neomycin phophotransferase II (NPTII) protein. Biotechnology 11:
1543-1547, 1993.
3
Harrison, L.A., Bailey, M.R., Naylor, M.W., Ream, J.E., Hammond,
B.G., Nida, D.L., Burnette, B.L., Nickson, T.E., Mitsky, T.A.,
Taylor,M.L., Fuchs, R.L. and Padgette, S.R. "The expressed
protein in glyphosate-tolerant soybean,
5-enolypyruvylshikimate-3-phosphate synthase from Agrobacterium sp.
Strain CP4, is rapidly digested in vitro and is not toxic to acutely
gavaged mice". The Journal of Nutrition, 126 (3): 728-740, 1996.
-
Also to include after the last paragraph of the item 12: Heat and
acid treatment of newly expressed protein, should be considered and
standardized, in case of food processing (at high temperatures) 1
1
see proposed Dr. Ricki M. Helm [Topic 5: Stability of Known
Allergens (Digestive and Heat Stability), paper - Joint FAO/WHO
Expert Consultation on Foods derived from Biotechnology).
Section
6 - Areas Requiring Further Development
17.
We suggest the inclusion of the specific sub items in the section 6:
1
- Animal Models;
2
- Targeted serum screening;
3
- Other techniques such as T-cell epitopes and structural motifs.
2
- Annex II
"Proposed
Revised text on entitled Assessment of Possible Toxicity from
Proposed ...Recombinant DNA-PLANTS"
A.
we suggest that the end of the sentence in boldface be
changed for "...activity of enzymes originated by introduced
DNA", because the expression "introduced enzymes"
could induce to a deceitful comprehension that the enzyme is the one
being introduced instead of the DNA.
B.
we suggest the substitution of the sentence in
boldface for "characteristic of newly expressed
substance as well its concentration in edible parts ",
since the term "function" is inadequate to
express, for example, the toxicity potential of the substance and
moreover, the composition involving the word "identify",
together with the remaining of the sentence, is not
sufficiently clear.
C. Replace "function"
for "characteristic" as justified in
paragraph B.
D. Replace "function"
for "characteristic" as justified in
paragraph B.
E. Replace "function"
for "characteristic" as justified in
paragraph B.
ANEXO
A POSIÇÃO BRASILEIRA PARA A 3ª REUNIÃO DO
GRUPO INTERGOVERNAMENTAL AD HOC DO CODEX SOBRE ALIMENTOS DERIVADOS DA BIOTECNOLOGIA
TEMA
6 - Resposta a CL 2001/46 - FBT
PROPOSED
DRAFT GUIDELINE FOR THE CONDUCT OF FOOD SAFETY ASSESSMENT OF FOODS
PRODUCED USING RECOMBINANT-DNA MICROORGANISMS
SECTION
1 - SCOPE
1.
It is not mentioned in the scope that such foods or food ingredient
could contain others components, or the new components produced by
recombinant-DNA Microorganisms.
-
Paragraph
1, line 3, footnote 1: definition of the term microorganisms.
For the purpose of the document, microorganisms are defined as
bacteria, yeasts, and filamentous fungi. This definition may,
according to interpretation, exclude groups which may also be
considered microorganisms by some specialists, such as mushrooms
(Basidiomycetes), which are widely used as food products in natura or
may be used as ingredients in prepared foods, or even for the production/extraction
of food additives, such as flavors and aromas (e.g., trufles). The
current definition also excludes the microalgae, which, in certain
cases, may be used as food additives (e.g., Chlorella). Genes from
other microorganisms, such as Archaea, may be used, in the future, in
food production. This definition should be broadened a little to
accommodate these.
- The
Brazilian Delegation also would like to request explanation if the
Scope of this Guideline has been applied only to the microorganisms
"per se", or food produced using recombinant-DNA
Microorganisms, such as filamentous fungi (mushrooms-Basidiomycetes).
- Paragraph
7: Term "microflora" should be replaced by "microbiota",
because with the modern taxonomic classification, fungi and
bacteria are not included to the plant kingdon.
- The
distribution of the normal microbiota is very variable on the human
body. It has been reported a resident and transient microbiota in/on
human body which should be considered in this annex. We must be aware
that the microbiota in mouth, oropharynx, stomach, small and large
intestine, skin, eye (conjuctiva), nose, etc are completely distinct
and should be carefully evaluated.
4.
Sub-item 4D): replace, in all documents, the gastrointestinal
"microflora" by "microbiota".
7.
In order to clarify the first paragraph of the item 7, it is
necessary to add as footnote, the wide acceptable variability in the
analytical differences (recombinant DNA microorgamism and
conventional counterpart) could be found between the parental and the
recombinant strains evaluated.
SECTION
2 - DEFINITIONS
Paragraph
8: Definition of "recombinant-DNA microorganism" is
broader than the definition of "genetically modified
organism" (GMO), and includes organisms that are produced by in
vitro methods; but seems to exclude from this definition those
derived from classical genetic manipulation methods, such as
random and directed mutagenesis, deletions and gene knock-outs,
directed evolution, and protoplast fusion with organisms from other
species or with other strains of the same species. All these later
methods can produce recombinant-DNA microorganisms with equal risk
potential as transgenic and the in vitro methods cited. We suggest
that the part of "recombinant-DNA microorganism" definition
- "including recombinant deoxyribonucleic acid (DNA) and direct
injection of nucleic acid into cell organelles" - should be
removed because these techniques have been defined in the footnote of
the same page.
SECTION
3 - INTRODUCTION TO FOOD SAFETY ASSESSMENT
Unintended
Effects
16.
Included the expression "and evaluated" after the
expression " to be considered, a more detailed information
should be assayed/studied".
SECTION
4- GENERAL CONSIDERATIONS
26.
It is necessary to include a new footnote to clarify the meaning
of insertion sequences. What kind of insertion sequences must be
considered in this situation?
-
1,The role of integrons in dissemination of antibiotic resistance. Annales
de Biologie Clinique. Vol. 58, Issue 4, 439-44, 2000.
-
2 The evolutionary history of chromosomal super-integrons provides
an ancestry for multiresistant integrons. Proc. Natl. Acad. Sci.
USA: Vol. 98, No. 2, 652657, January 16, 2001.
Safety
Assessment
Expressed
Substances Including Toxins or Other Traits Related to Pathogenicity
37.
In the second paragraph, after the phrase "recombinant-DNA
microorganisms", insert the preposition "from" in the
beginning the phrase: " the food product if the substance is
secreted ".
38.
Include in the second bullet after "chronic
toxicity/carcinogenicity', the word "mutagenicity".
Antibiotic
Resistance and Gene Transfer
49.
Include "super-integrons" after integrons", since this
is a new class of mobile DNA element2, that should be assayed.
-
2 The evolutionary history of chromosomal super-integrons provides
an ancestry for multiresistant integrons. Proc. Natl. Acad. Sci. USA:
Vol. 98, No. 2, 652657, January 16, 2001.
56.
Keep the whole paragraph in square brackets, until appropriate
information on the uses of additional conventional foods or food
components may be obtained.
General
considerations:
-
Evaluation
parameters of the proteins expression, metabolites, alergenicity
features and residence of the recombinant microorganism in the human
digestive tract, besides the influence of the organism in the
composition and nutricional aspect and food processing they are
appropriate for risk evaluation and food safety.
- Safety
Recommendations in the strategy applied for genetics modification
are appropriate, including, for example, the necessity to avoid the
hosts with transmissible plasmids with antibiotic resistance genes
the use of vectors suicides and other systems drawn to assure the
non-gene transfer in the host genome.
- Information
about the genetic construction should be provided, the stability of
the gene(s) inserted will be better acceptable if the same genes were
inserted in the microbial chromosome. That condition, particularly to
bacterias, should be proposed/demanded.
ANEXO
A POSIÇÃO BRASILEIRA PARA A 3ª REUNIÃO DO
GRUPO INTERGOVERNAMENTAL AD HOC DO CODEX SOBRE ALIMENTOS DERIVADOS DA BIOTECNOLOGIA
TEMA
7 - Resposta a CL 2001/27 - FBT
Brazilian
Delegation Position to be presented in the Course of the Codex Task
Force CX-FBT on Traceability
Traceability
is being discussed by several Codex Committees besides CX-FBT
because this subject exceeds the limits of the discussions of the
foods characterized as GMOs or Foods Derived from Modern Biotechnology.
Contrary
to the idea sustained by the French Delegation to whom Traceability
should be treated as a register system of outstanding value for Risk
Analysis of Foods, Brazil considers Treaceability as a system aiming
only to provide information concerning the origin, processing and
localization of Foods Derived from Modern Biotechnology. This system
could be of great importance not only to consumers, but also to
producers and market operator agents as well.
The
Brazilian Delegation is discussing Traceability from the developing
countries point of view, where this issue should be characterized as
a voluntary system deprived from a mandatory character. Also, the
technical and economical viabilities, the ethic dimension of these
issues as well as the existing capabilities of the developing
countries to line up and to be able to follow the international
guidance, should be taken into consideration.
The
Brazilian position regarding the Codex Committees discussions
related to Traceability takes into consideration the framework of the
Brazilian Biosafety Legislation , which establishes rules of great
severity only when there is a risk that threatens human, or animal
health, or the environment. The Brazilian Biosafety Legislation
establishes priorities and differences regarding the assessment of
the risks inherent to foods derived from Modern Biotechnology. For
example, the normative rules nº 2 and 4 of the Brazilian
Biosafety Legislation establish that if someone is dealing with food
or any material considered as category of Risk - "Group 1",
there is no need to obtain authorization from the National Technical
Biosafety Committee - CTNBio) , but if the food is classified in the
category of risk "Group 2" the applicant has to apply to
the Committee for permission.
The
Brazilian Delegation position presented during the meeting of
CX-FBT-Codex helded in Genebra (2-7 of july, 2001) was consistent
with our national rules. The Brazilian Committee considered that
Traceability, is not a matter of risk, but a question of information
to the consumers.
Understanding
that this subject should not to be taken as a matter of Risk
Analysis, we consider the next points:
In
summary, the Brazilian Delegation does not support the inclusion of
the Traceability related discussion at this point, as it exceeds the
mandate of the FBT.
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