The 7th Session
of the Codex Task Force on Foods Derived from Biotechnology was
highly successful. Work was completed on all three substantive documents
under consideration by the Task Force. Specifically, the following
three documents were advanced to Steps 5/8 of the Codex accelerated
procedure.
- Guideline for the Conduct of Food Safety Assessment of Foods
Derived from Recombinant-DNA Animals.
- Food Safety Assessment of Foods Derived from Recombinant-DNA
Plants Modified for Nutritional or Health Benefits as an Annex
to the Codex Guideline for the Conduct of Food Safety Assessment
of Foods Derived from Recombinant-DNA Plants.
- Food Safety Assessment in Situations of Low-Level Presence
of Recombinant-DNA Plant Material in Food as an Annex to the Codex
Guideline for the Conduct of Food Safety Assessment of Foods Derived
from Recombinant-DNA Plants.
The Seventh Session of the Codex ad hoc Intergovernmental Task
Force on Foods Derived from Biotechnology was held in Chiba, Japan,
September 24–28, 2007. The Session was hosted by the Government
of Japan and presided over by Dr. Hiroshi Yoshikura, Adviser, Department
of Food Safety, Pharmaceutical and Food Safety Bureau, Ministry
of Health, Labor and Welfare. 196 delegates, representing 52 members
of the Commission and 4 international intergovernmental and 13 non-governmental
observer organizations attended the Session. Representing the United
States were U.S. Delegate, Dr. Eric Flamm, FDA, 13 government advisors
and 5 non-government advisors.
The full report of the 7th Session can be found in ALINORM 08/31/34
on the Codex Web site.
The following summarizes the issues of particular interest to the
U.S. Delegation.
Proposed Draft Guideline for the Conduct of Food Safety
Assessment of Foods Derived from Recombinant-DNA Animals
The 6th (2006) Session of the Task Force had a thorough discussion
on the Guidelines and reached consensus on all provisions with the
exception of two sections dealing with: 1) the use of antibiotic
marker genes; and 2) non-heritable constructs. The 7th Session Task
Force agreed to focus discussion on these two sections. The 6th
Session of the Task Force also requested FAO/WHO to hold a Joint
Expert Consultation on these two issues; the Consultation was held
February 26–March 2, 2007.
Regarding antibiotic resistance marker genes, several delegations,
including the United States, expressed the view that the report
of the FAO/WHO expert consultation did not yield any new scientific
evidence to warrant further modification or addition to the provisions
on the section on antibiotic resistance marker gene, compared to
the corresponding section in the Codex Plant Guideline. Based on
the findings of the FAO/WHO expert consultation, the Task Force
agreed to leave the current text in this section unchanged.
Regarding non-heritable constructs, the discussion focused on the
use of r-DNA vaccines and whether food safety issues could arise
with respect to their use. The Delegation of the European Community
pointed out that the FAO/WHO expert consultation addressed the issues
on non-heritable constructs in detail and provided a series of conclusions
and recommendations regarding, among others, potential hazards in
relation to non-heritable constructs. The Delegation of the European
Community noted that the draft proposed guideline did not address
non-heritable constructs and proposed two amendments to reflect
this fact in the text. Some delegations supported the Delegation
of the European Community, noting that the expert consultation's
recommendations recognized there might be a need to develop additional
guidelines on non-heritable constructs in the future. Several delegations,
including the United States, questioned whether non-heritable constructs
were beyond the scope of this draft guideline. After some discussion,
the Task Force agreed to both include a footnote to paragraph 1
to clarify that the draft proposed guideline had been developed
primarily for animals bearing heritable recombinant DNA constructs
and add a footnote to indicate the possible need for additional
specific consideration for the food safety assessment of non-heritable
constructs.
The Task Force agreed to forward the proposed draft guideline,
with the aforementioned amendments, for adoption at Steps 5/8 by
the 31st Session of the Commission, with the recommendation to omit
Steps 6 and 7.
Proposed Draft Annex to the Guideline for the Conduct of
Food Safety Assessment of Foods Derived from Recombinant-DNA Plants:
Food Safety Assessment of Foods Derived from Recombinant-DNA Plants
Modified for Nutritional or Health Benefits
At the Sixth Session, the Task Force agreed to a physical Working
Group to be led by Canada, co-chaired by Argentina and New Zealand
and open to all the members and observers. The Working Group agreed
to return the proposed Draft Annex to Step 2 for redrafting by a
physical working group. The Working Group also agreed to exclude
from the scope of the proposed draft annex, risk management measures
and assessment of benefits.
The Task Force undertook a paragraph-by-paragraph discussion of
the draft Annex and agreed to the following changes:
- The Task Force added the words "introduction of new nutrient(s)
or related substance(s)" to the scope section of the Annex's introduction
to clarify that the Annex covers nutrients or related substances
newly introduced through r-DNA techniques.
- The Task Force agreed not to develop additional definitions
to terms referred to in the Annex, including those relevant to
nutritional risk assessment. The Task Force agreed to both insert
text noting that the definitions of key nutritional concepts could
be found and/or later be developed in relevant Codex text, in
particular, text elaborated by the CCNFSDU
and invite the 29th
Session of CCNFSDU to review the document and provide comments,
where necessary.
- Regarding the issue of upper levels, the Task Force noted that
there were limitations to the available dose-response and clinical
data in identifying risk association with nutrients at high levels
of intake. The Task Force agreed to add new text, suggested by
the United States, on the need to consider the basis for deriving
upper levels in assessing the public health implication of exceeding
intake levels of nutrients.
- The Task Force deleted the reference to Acceptable Daily Intake
(ADI), recognizing that in Codex standards-setting and in JECFA
risk assessments, the concept of ADI was typically used for the
assessment of chemicals such as food additives and residues of
veterinary drugs in food and would not necessarily be applicable
to the safety assessment of nutrition.
- The Task Force considered how to take into account the occurrence
of more than one form of a chemical nutrient. The Task Force agreed
not to use the terms "multiple" and "analogues" and instead use
the phrase "more than one chemical form". The Task Force also
discussed bioavailability regarding chemical forms of a nutrient
and agreed to add a new sentence stating that "if more than one
chemical form of the nutrients or related substances is present,
their combined bioavailability should be established, where appropriate"
in the paragraph relating to bioavailability.
- Regarding the need for further guidance on the use of animal
studies, the Task Force agreed to add a new sentence which states
that "in-vivo studies in animals are of limited value in assessing
nutritional value or nutrient bioavailability for humans and would
require careful design in order to be relevant."
- After discussion on the issue of evaluating exposure to r-DNA
plants with nutritional modification, particularly with respect
to evaluating nutritional or health benefits as part of the safety
assessment, the Task Force agreed to add a new sentence as follows:
"When evaluating the exposure, it is appropriate to consider information
on whether consumption of the modified food could lead to adverse
nutritional effects as compared to consumption of the food that
it is intended to replace."
- The Task Force also agreed to delete reference to FAO diet
data and the FAO Food Balance Sheets since these two items, as
pointed out by the Joint FAO/WHO Joint Expert Consultation on
nutritional risk assessment, provide limited information for quantitative
exposure estimation. The Task Force agreed however to include
a footnote noting that "data on staple food products may also
be supplemented by information from FAO Balance sheets."
The Task Force agreed to forward the Annex to the Commission for
adoption at Steps 5/8 of the Accelerated Procedure. The Task Force,
recognizing that the Annex contained references to certain concepts
related to nutrition, agreed to invite CCNFSDU to review the document
and provide comments where necessary.
Proposed Draft Annex to the Guideline for the Conduct of
Food Safety Assessment of Foods Derived from Recombinant-DNA Plants
on Low-Level Presence of Recombinant-DNA Plant Material
The Task Force, at its 6th (2006) Session, recommended development
of an Annex to the Plant Guideline on "Food Safety Assessment in
Situations of Low-Level Presence of Recombinant-DNA Plant Material
in Food." The United States chaired (along with Germany and Thailand
as co-chairs) a Working Group to develop the document. The document
contains two basic sections, one on food safety assessment and a
second on information sharing that focuses on a new database to
be developed by FAO as a component part of FAO's International Portal
on Food Safety, Animal and Plant Health (IPFSAPH).
The Task Force considered two formats for the food safety component,
a short version which essentially referenced only those changes
to the Plant Guideline and a longer version which repeated the Plant
Guideline modified for use in low-level situations. The Task Force
agreed to the short form as the preferred form for the Annex.
The Task Force made no substantive changes to the food safety assessment
portion of the Annex.
Regarding the draft guidance on data and information sharing, the
European Community proposed several modifications, which were discussed
at length by the Task Force and further modified by the Task Force.
- The European Community Delegation proposed to include in the
database specific references to Cartagena Protocol and/or OECD
BioTrack Product Database in the notifications. Some Delegations
expressed the view that specific references to the Cartagena Protocol
and OECD BioTrack in the Database could be construed as an endorsement
of these organizations to which not all Delegates were Members
of and questioned the relevance and necessity of referring to
these resources in the database. The Task Force ultimately agreed
to refer in the database "links to the information on the same
product in other databases maintained by relevant international
organizations, as appropriate."
- The Delegation of the European Community also proposed that
the summary of the safety assessment should follow the structure
of the headings of the Codex Plant Guidelines. Several Delegations
noted that revising the food safety summary to adhere exactly
with the structure of the headings of the Codex Plant Guidelines
could pose a burden for those countries whose national legislation
requires a different format for such summaries. After extensive
discussion, the Task Force agreed to modify the European Community's
proposed language to state that the summary of the safety assessment
should be consistent with the framework of the food safety assessment
of the Codex Plant Guideline.
- The Delegation of the European
Community also proposed that the summary of the safety assessment
should focus on the areas of specific relevance and interest of
the risk assessor and include either a validated protocol for
an event specific detection method suitable for low-level situations
and appropriate (either viable or non-viable reference material)
or information on where these can be secured. The Delegation of
the European Community expressed the view
that such information was crucial to facilitating the management
of low-level presence circumstances and for the rapid assessment
of the actual presence of the recombinant-DNA plant materials
in commodities. Some Delegations expressed the view that information
such as specific detection method protocols and certain reference
materials may not be obtainable for reasons such as confidentially
concerns. After further discussion, The Task Force ultimately
agreed to a new database element: "where detection method protocols
and appropriate reference material (non-viable, or in certain
circumstances, viable) suitable for low-level situations may be
obtained" with a footnote reading "This information may be provided
by the product applicant or in some cases by Codex members".
The Task Force agreed to advance the document to Steps 5/8 for
adoption by the Commission at the CAC's 2008 Session. The Task Force
agreed to request FAO to provide an update on the database at the
2008 Session of the Commission.
Other Business and Future Work
The Observer from the OIE informed the Task Force that as a follow-up
to the FAO/WHO Expert Consultation on the Safety Assessment of Foods
Derived from Recombinant-DNA Animals (26 February–2 March 2007),
the OIE may consider convening an expert meeting, jointly with FAO
and WHO in 2008, to consider the issues related to the animals with
non-heritable recombinant-DNA constructs including recombinant-DNA
vaccines.
Date and Place of Next Session
Given that the three proposed draft documents were advanced to Steps 5/8,
no further session of the Task Force was foreseen. Should the need
for another session of the Task Force arise following the consideration
of these proposed drafts by the 31st Session of the Commission in
July 2008, the host government would make the necessary arrangements
in consultation with the Codex Secretariat. |