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6-Regulation: Analysis of key decision at Biosafety Protocol meeting



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TITLE:  Analysis of key decision at Biosafety Protocol meeting
SOURCE: South-North Development Monitor
        http://www.biosafety-info.net/article.php?
aid=351&PHPSESSID=a9e68bc806d457819a2e1c37c89ef3a6
DATE:   22 Mar 2006

------------------ archive:  http://www.genet-info.org/ ------------------


Analysis of key decision at Biosafety Protocol meeting 

Curitiba, 21 Mar (Lim Li Lin and Lim Li Ching) -- The 3rd Meeting of the
Parties (MOP3) to the Cartagena Protocol on Biosafety (under the
Convention on Biological Diversity), which met from 13-17 March in
Curitiba, Brazil, adopted several decisions which have significant
implications for the production and the trade of genetically modified
organisms, or in the language of the Protocol, living modified organisms
(LMOs).

The process by which the most important decision (relating to Article
18.2(a) of the Protocol, on identification requirements for shipments of
commodities containing LMOs) was taken was protracted, and at times it
seemed as if there would not be any outcome on these issues (See SUNS
#5990 dated 21 March 2006).

The following is a summary of aspects of this key decision taken at the
meeting.

"Contain" vs. "may contain": The 3rd Meeting of the Parties (MOP3) to the
Cartagena Protocol on Biosafety adopted a decision that requires clear
and detailed identification requirements for shipments of GM commodities
(known as LMO-FFPs - living modified organisms intended for direct use as
food or feed, or for processing - in the Biosafety Protocol). A two-stage
approach
is set out for cases where the identity of the LMO shipment is not known.

In situations where the identity of the LMO is known through "means such
as identity preservation systems", the shipment must be identified as one
that "contains" LMOs that are for direct use as food or feed, or for
processing.

In cases where the identity of the LMO is not known through "means such
as identity preservation systems", the shipment can be identified as one
that "may contain" one or more LMOs that are intended for direct use as
food or feed, or for processing. This requirement is subject to review
and assessment at the 5th Meeting of the Parties (2010), "with a view to
considering a decision" at the 6th Meeting of the Parties (2012) to
ensure that the shipment "contains" LMO-FFPs.

This two-stage approach was essentially a compromise position put forward
by Brazil, although it was weakened by an extension of the initially
proposed 4-year interim period to 6 years, when the "contains"
requirement should come into effect. The language referring to this was
also weakened from "with a view to adopting" to "with a view to
considering" a decision.

Nevertheless, and importantly, it is clearly stated that the final
decision after the interim period is to "ensure" that the documentation
"clearly states that the shipment contains LMOs that are intended for
direct use as food or feed, or for processing". This means that the "may
contain" language should no longer be an option after the interim period.

While "identity preservation systems" is not defined in the text or in
the Protocol, it can be understood to mean segregation and testing, and
is non-exhaustive. The language "known through means such as identity
preservation systems" is broad enough to cover different ways of ensuring
that the identity of the shipment is preserved.

It would be important for the importing Party to define in its national
law, what its requirements are in order to meet this criterion, rather
than leaving this to the country of export to define. If this is left to
the country of export to define, it would open the door for the exporting
country to constantly argue that it cannot meet the "contains"
requirement because it does not have an identity preservation system or
other such means in place.

In both cases, where the shipment is identified as one that "contains"
LMOs as well as where the shipment is identified as one that "may
contain" LMOs, the documentation accompanying them must include the
following details:

- that the LMOs are not intended for intentional introduction into the
environment

- the common, scientific and, where available, commercial names of the LMOs

- the transformation event code of the LMOs or, where available, as a key
to accessing information in the Biosafety Clearing House (BCH), its
unique identifier code

- the internet address of the BCH for further information

(In relation to the third point, all LMOs are also known by their
"transformation event code", which distinguishes between the different
transgenic lines. Some LMOs have a "unique identifier code" which acts as
a key to accessing full information about the LMO in a database. The BCH
is a publicly accessible internet based database which is administered by
the Secretariat of the Convention on Biological Diversity which provides
some information about LMOs, and is part of the implementation of the
Biosafety Protocol.)

This means that whether or not a shipment is identified as one that
"contains" or "may contain" LMOs, a list of transformation events or
unique identifier codes that are or may be in the shipment, must be
provided. These specifications are required for all shipments.

Adventitious presence and thresholds: The "may contain" provision is
further qualified by the statement - "acknowledges that the expression
"may contain" does not require a listing of LMOs of species other than
those that constitute the shipment".

Thus, the scheduled expiry of the "may contain" language in 2012 will
mean that this qualification also expires then.

Arguably, "adventitious" (or technically unavoidable, unintentional and
low-level) presence of LMOs (e. g. traces of LMOs that are found in
shipments) of the same species (e. g. GM soya in a shipment of non-GM
soya or a particular GM soya found in a shipment of another GM soya) is
covered by the decision, where the identity of the LMOs is not known, and
the shipment is identified as "may contain".

This means that such unintentional adventitious presence must also be
specified in the documentation, e. g. through the provision of the
transformation event code of the LMO that is unintentionally present, if
it is of the same species of the LMOs in the shipment.

However, this does not mean that if a shipment is identified as
"contains", that there can be "adventitious" presence of LMOs, whether of
the same or different species. This is left to the national level to
define, as the documentation requirements must be in "compliance with the
requirements of the country of import".

What is only clearly excluded is "adventitious" presence or traces of an
LMO of one species in a shipment of another species (e. g. GM maize in a
shipment of non-GM wheat, or GM maize in a shipment of GM soya) when the
identity of the LMOs is not known, and the shipment is identified as one
that "may contain" LMOs.

Thus, the issue of thresholds, which is a percentage of GM contamination
above which identification requirements are triggered, was avoided in
this decision, but remains an issue to be determined at the national
level, "in compliance with the requirements of the country of import".

Approved LMOs only: All of the above scenarios require that the LMOs in
question must be approved in the Party of import. There is full
flexibility for a country to require zero tolerance of unapproved and
illegal contamination of LMOs, as measures must be taken to ensure that
LMO-FFPs are "authorized in accordance with domestic regulatory
frameworks" and the documentation is "in compliance with the requirements
of the country of import".

Even though the documentation accompanying LMO-FFPs is qualified to be
applicable for LMO-FFPs that are in "commercial production" (i. e. not
research and field trials), this must be "authorized in accordance with
domestic regulatory frameworks". It is not specified whether this refers
to domestic regulatory frameworks in the country of export or in the
country of import, and thus can be interpreted as referring to both
exporting and importing countries.

In any case, the documentation must be "in compliance with the
requirements of the country of import". This means that the importing
country needs to put in place strict requirements, to ensure that even
contamination by LMOs in field trials and research (which are unapproved
commercially) is prohibited.

The fact that the documentation must be for LMO-FFPs "authorized in
accordance with domestic regulatory frameworks" and "in compliance with
the requirements of the country of import" implicitly extends to the
approval or authorization procedure in the country of import.
Documentation requirements are only triggered once a particular LMO has
been approved by the country of import.

Biosafety Clearing House: In addition, Parties and other governments are
invited to make available to the BCH:

- the transformation events that are commercially produced for each
planting cycle in the exporting country

- the geographical area within the exporting country where each
transformation event was cultivated

- the common, scientific and, where available, commercial names of the LMOs

- the transformation event code of the LMO or, where available, as a key
to accessing information in the Biosafety Clearing House, its unique
identifier code

These are new requests for additional information about commercialized
LMOs that countries are invited to submit to the BCH.

'Stand-alone' document: The decision postpones the issue of whether a
'stand-alone' document is needed as the document accompanying LMO-FFPs. A
separate, 'stand-alone' document is essential, so that the competent
authority responsible for biosafety can more easily gain access to, and
have oversight over, the document, which would not necessarily be the
case if the
information were simply added onto an existing commercial invoice.

The decision asks Parties and other Governments to submit information on
the experience gained with the use of documentation, with a view to
further harmonization of a documentation format, including consideration
of the need for a stand-alone document, which will be compiled and
synthesized for consideration at MOP5.

It is important to note that Parties can already require the use of
stand-alone documents in their national laws, or even within their
administrative frameworks, as the decision also allows for the use of
documentation as required by domestic regulatory and/or administrative
frameworks. The document must include all the information specified in
shipments identified as both "contain" and "may contain", and should be
easily recognized and transmitted. The information requirements should
also be effectively integrated, considering standard formats.

Contact point for further information: The decision also specifies that
the details of a contact point for further information must be provided
in the documentation. These are identified as the exporter, the importer,
and/or any appropriate authority, when designated by a Government as the
contact point.

This is important, as it extends the contact points for further
information beyond the last exporter and first importer in the supply
chain, which are usually the same grain trading companies. For example,
grain exported from Brazil to South Africa may likely be exported from
Cargill in Brazil to Cargill in South Africa. The grain trading companies
may not hold important
biosafety information, which may reside with the companies and producers
of the GMOs.

Parties can also designate appropriate authorities, such as the biosafety
focal point, as a contact point for further information. This would
extend biosafety regulatory oversight, for example, at the entry port of
a country, the customs officials can contact their relevant biosafety or
competent
authorities for more information about an LMO-FFP shipment. This would
also ensure that the competent authority responsible for biosafety knows
about a shipment of LMO-FFPs entering the country, which would be
particularly important if a stand-alone document is not utilised.

Capacity-building: The issue of capacity-building also features in the
decision, with the review and assessment to be undertaken at MOP5
regarding the retirement of the "may contain" language. The decision
mandates that the review at MOP 5 shall also include an examination of
capacity building efforts in developing countries. Funding is also
requested to be mobilized for to support the implementation of Article
18.2(a).

One of the issues that arose during the negotiations was that developing
country exporters need capacity-building if they are to implement the
decision, particularly with respect to "means such as identity
preservation systems". One key consideration that should be taken into
account when it comes to implementing capacity-building, would be
differentiating between the roles and needs of exporting developing
country governments and responsible agencies, which may require capacity-
building, and between the roles played by the international grain trading
companies that may operate silos, ports and transportation systems. The
latter should not be subsidized
by the international community to implement "means such as identity
preservation systems".

Furthermore, on the issue of capacity-building, developing country
importers could be assisted on issues such as sampling and detection,
testing and monitoring of LMO-FFPs. If there is a lack of capacity in
developing country importers, quickly implementing the "contain"
requirements along with the detailed identity requirements would help
address the lack of capacity to test and monitor LMO-FFP imports, as this
shifts the burden and cost of assessing the LMO content of a shipment
from the importer to the exporter.

Sampling and detection techniques: In this respect, the decision also
encourages cooperation in exchanging experiences and building capacities
on sampling and detection techniques. It also asks for the submission of
information on experience gained with the use of sampling and detection
techniques and on the need for and modalities of developing criteria for
acceptability of, and harmonizing, sampling and detection techniques, for
consideration by the next MOP (MOP4).

Importing Parties will still have to carry out random sampling and
detection for LMO content in shipments, even if all the information is
provided by exporters, to ensure accuracy of the information and to
verify that no unapproved varieties are entering the country. In
particular, exporting countries could assist by providing the detection
methods and reference materials for all approved LMOs (which should also
be stipulated in domestic regulatory frameworks as one of the conditions
for any approval, as it will not be possible to test for specific LMOs if
the detection methods and reference materials are not made available to
importing countries). This should also apply to experimental LMOs, which
can contaminate seeds and crops.

Trade with non-Parties: The decision notes that trans-boundary movement
between Parties and non-Parties shall be consistent with the objective of
the Protocol. It further notes that the specific requirements for the
documentation ("contains"; "may contain"; not intended for intentional
introduction into the environment; common, scientific and, where
available, commercial names of the LMOs; transformation event code or,
where available unique identifier code of the LMO; and internet address
of the BCH) do not apply to such trans-boundary movement. In addition,
Parties should encourage non-Parties to adhere to the Protocol.

This could be understood to be simply a restatement of Article 24 of the
Protocol and a general principle of international law, as clearly non-
Parties cannot be bound by a decision of the Biosafety Protocol. Thus
non-Party exporters do not have to put these requirements in place,
although they are "urged" to do so.

However, the specific requirements in question also stipulates that the
documentation must comply with the requirements of the Party of import,
hence, Parties who are trading with non-Parties can still set up their
domestic legislation to ensure that strict requirements are put in place,
based on the decision as a minimum standard, which will bind all
countries that they import from, and this includes both Parties and non-
Parties.

It can also be argued that since only the specific requirements for
documentation are noted not to apply to trans-boundary movements between
Parties and non-Parties, the converse is applicable - that the rest of
the provisions of this decision should apply to trans-boundary movements
between
Parties and non-Parties, and thus Parties are under an obligation to
ensure that all these provisions are put in place in their national laws,
as a minimum, and that this will also then apply to trade with non-Parties.

In addition, Article 2(4) of the Protocol preserves the right of Parties
to "take action that is more protective of the conservation and
sustainable use of biological diversity than that called for in this
Protocol, provided that such action is consistent with the objective and
the provisions of this
Protocol and is in accordance with that Party's other obligations under
international law", and this is recalled in a pre-ambular paragraph in
the decision.

It is therefore crucial that this decision on Article 18.2(a) be
implemented, especially in Parties of import, so that exporting
countries, whether Parties or non-Parties, must adhere to their domestic
laws, which should be based on this decision as a minimum standard.

Nonetheless, the implications of these particular provisions need to be
further examined, particularly in the light of the current push for
bilateral free trade agreements by the US and other exporting non-
Parties, and in the context of the WTO agreements.

Conclusion: In summary, the MOP3 decision on Article 18.2(a), as the
international minimum standard, will help encourage a global system of
identity preservation, segregation, and traceability for GMOs, and help
to prevent the contamination that is happening. It will help restore the
burden to its rightful place, help to ensure that countries or regions
can choose
to remain GM-free and ensure that they do not receive LMOs that are not
approved in their countries. The decision will eventually help importing
countries to know exactly what is coming into their countries, and will
help ensure important biosafety functions e. g. monitoring, meaningful
labelling, product recall in the case of harm and assigning liability if
damage occurs.

For all this to happen, importing Parties should now urgently ensure that
the decision is implemented by incorporating these requirements, as a
minimum standard, into their national laws.

Exporting Parties should also quickly implement their obligations under
this decision, and put in place a proper system of segregation, testing
and identity preservation sooner rather than later. An identity preserved
grain trading system is of benefit to all. +

--
GENET
European NGO Network on Genetic Engineering

Hartmut MEYER (Mr)
news & information

phone....... +49-531-5168746
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email....... news(*)genet-info.org
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