Past Discussions 2013

Dear Participants of the Laboratory Network,

Welcome to the third round of discussion of the Network of Laboratories for LMO Detection & Identification. The topic that will be focused on in this forum for the next two weeks is regarding “Challenges and Progress in the Detection of LMOs Unintentionally Released into the Environment and Unauthorized LMOs”.

In the page of the discussion (http://bch.cbd.int/onlineconferences/portal_detection/discussions.shtml#theme6), we have provided a brief overview on the issue of unintentionally released and unauthorized LMOs. We have also listed a few guiding questions (below) to help initiate the discussion. However please feel free to bring up other related issues that you would like to discuss.

1. Does your regulatory context make a distinction between “unauthorized LMOs” and “unintentionally released LMOs”?
2. How does your regulatory context address the limits for potential adventitious or low level presence in its imports of LM material already authorised and being produced in other countries, but not yet approved in your country?
3. Is your laboratory capable of detecting and identifying unauthorized and/or unintentionally released LMOs both in the context of traceability (e.g. in shipments) and environmental monitoring? If so, what strategies is your laboratory employing in order to detect unauthorized and/or unintentionally released LMOs ? If not what are the barriers to adopting such a strategy?

We are looking forward to a fruitful discussion!
Best Regards,
Dina

Dear All,

Here are some my comments to the proposed questions:

1. Does your regulatory context make a distinction between “unauthorized LMOs” and “unintentionally released LMOs”?

- The regulation on biosafety in my country distincts in the Art 38 the "illegal import" of LMOs, and in Art.39 - "unintentionally transported" (imported) of LMOs. There is no stipulated any distinction related "unauthorased".  This would be a request to improve the national regulation in order to distinct these specific categories of LMOs.

2. How does your regulatory context address the limits for potential adventitious or low level presence in its imports of LM material already authorised and being produced in other countries, but not yet approved in your country?

- There is no specific regulatory requirements related the limits or low lwvwl of presence of LM material in imports. We may refer to the Art. 24 that stipulates general request for labelling of products that contain LMO more then 0,9%, and seeds more then 0,3%.

3. Is your laboratory capable of detecting and identifying unauthorized and/or unintentionally released LMOs both in the context of traceability (e.g. in shipments) and environmental monitoring? If so, what strategies is your laboratory employing in order to detect unauthorized and/or unintentionally released LMOs ? If not what are the barriers to adopting such a strategy?

- There is limited national laboratory capacity to detect and identify the unauthorised and/or unintentionally released LMOs. To mention,  recently in collaboration with a Lythuanian laboratory  the botanical impurification of samples of corn cultivated in the country with presence of GM soybean less then 0,1% was detected. Coordinated activities between the LMO detection laboratory, evironemntal inspection, agricultural inspection and the custom control services in the country that would ensure the environemntal monitoring and also unautorised import of LMOs in a regular base are expected to be applied. 

Best regards,
Angela Lozan, ME Moldova

Dear colleagues,
In Lebanon, there are no legislations that define the list of authorized GM events, and consequently there are no national regulatory measures that distinguish between the “unauthorized GMOs” and “unintentionally released GMOs”. Experimentally, at our AUST/ATL laboratory we established a testing regime that is based on a matrix representing all authorized and unauthorized in the food and feed related crop species. The employed methodologies for the detection of the target GM elements are based on conventional PCR, and they proved to be specific and sensitive to low percentages of GMOs content. Therefore, unauthorized and/or unintentionally released GMOs can be detected. In addition, the matrix strategy facilitates the identification of the potential events.

Dear Colleagues,
A draft Biosafety Law has recently been discussed among different Jordanian parties. The law should be enacted towards the end of 2013. The new Law for handling GM products does not show any distinction between “unauthorized LMOs” and “unintentionally released LMOs”. However, article 13 indicates clearly that the License of the product should show the allowed quantity of authorized LMO. On the other hand, the law does not address the limits of GMO or LMO material already authorised and those being produced in other countries, but not yet approved in Jordan.
Concerning the technical capability of the Biosafety Unit at RSS, the Unit has the capability of detection of authorized genetic events and conducting comparative genetic analysis on foreign DNA elements which should not be present in the authorized GMO. However, our lab lacks DNA sequencing facility.

Best regards,
Nisreen AL-Hmoud
Royal Scientific Society of Jordan

Dear all,

Thanks to the Secretariat for hosting once again this very important discussion. Here are some of my thoughts about the proposed questions.

1. Does your regulatory context make a distinction between “unauthorized LMOs” and “unintentionally released LMOs”?
Similar to what has been described by our colleague Angela from Moldova, Brazilian legislation does not make a clear distinction between “unauthorized LMOs” and “unintentionally released LMOs”. For example, the Normative Resolution No. 02 (November 27th 2006) about monitoring norms of genetically modified
corn in commercial use, in its Chapter III, states: “Article 6. All GMO activities and projects and its derivatives in contention should be planned and executed in accordance with CTNBio’s Normative Resolutions in order to avoid accidents or accidental release.” Or Biosafety Law 11.105/2005 “Article 29. For the non-authorised production, storage, transportation, marketing, import or export of GMOs and their by-products, breaching the norms provided by CTNBio and by registration and inspection agencies and entities: Punishment by confinement from 1 (one) to 2 (two) years and fine.”

2. How does your regulatory context address the limits for potential adventitious or low level presence in its imports of LM material already authorised and being produced in other countries, but not yet approved in your country?
In Brazil, there is no specific regulation that discriminates LMOs that are authorized or not in other countries. The regulatory requirements are mainly related to the approval or not in Brazil. But I am tempted to say that it does leave room for discussions.
If we refer to the labeling regulation, it states that “products that contain or might be produced from LMOs that are present above the limit of one percent of the product should be labeled”. It does not clearly state if the observed transgenic material must be approved in the country or not.
But at the same time, although the legislation does not require 100% confidence, it is considered a crime to import non-authorized LMOs (Article 29, Law 11.105/2005). Whether an import with less than 1% of an unauthorized LM material will be considered a crime or not is not fully clear. As said in previous posts, there are inconsistencies between the Labeling Decree and the Biosafety Law in Brazil.

3. Is your laboratory capable of detecting and identifying unauthorized and/or unintentionally released LMOs both in the context of traceability (e.g. in shipments) and environmental monitoring? If so, what strategies is your laboratory employing in order to detect unauthorized and/or unintentionally released LMOs? If not what are the barriers to adopting such a strategy?
The first barrier is access to information about unauthorized and/or unintentionally released LMOs. Second, any lab working with non-authorized LMO in Brazil must have a specific Biosafety Certificate. But I must say that our lab does not perform traceability (e.g. in shipments) and environmental monitoring investigations. Therefore, I am not fully aware of their capabilities and difficulties.

Best wishes,

Sarah Agapito

Dear all,
We would like to thanks the Secretariat for the chance to share some comments about these specific experiences.

1.Does your regulatory context make a distinction between “unauthorized LMOs” and “unintentionally released LMOs”?
Into the Mexican regulation, it possible to talk about unauthorized LMOs release in three classifications: “accidental release” (refereeing about non voluntary or non intentional release, like in the LMOs transportations accidents); “unintentionally released LMOs” (referring about a LMO release but without know that it was a LMO) and finally the “unauthorized released LMOs” (talking about a voluntary LMO release without the proper permission or authorization)
Preventing the possibility of unauthorized LMO release events to the environment, and for the Inter Secretarial Commission of Genetic Modified Organism (CIBIOGEM) instructions, the Secretary of Finance and Public Credit (SHCP); Secretary of Agriculture, livestock, rural development, fishing and feeding (SAGARPA); Secretary of environment and natural resources (SEMARNAT), and Secretary of Health (SSA) have prepared a protocol for coordinated action between the competent agencies to deal diligently and opportune these incidents, based in the General Law of Ecological Balance and Environmental Protection (art. 81,82 &170); Rules of the General Law of Ecological Balance and Environmental Protection (art. 5 & 81), Biosafety Law of  genetically modified organisms (art. 113, 114, 115 & 117); General Law of Health (art. 62, 63, 64bis & 282 bis 1).
The activation of the protocol begins with the notification of the LMOs release (it could be done for governmental dependencies, citizens, screening activities, etc.), basic information like site of release, etc followed for the info confirmation; response definition; measures application and, if it would be necessary, administrative procedure.

2. How does your regulatory context address the limits for potential adventitious or low level presence in its imports of LM material already authorized and being produced in other countries, but not yet approved in your country?
Currently, our regulatory context doesn´t have an established threshold for the AP and LLP, but a work group inside the CIBIOGEM is beginning the topic discussion.

3. Is your laboratory capable of detecting and identifying unauthorized and/or unintentionally released LMOs both in the context of traceability (e.g. in shipments) and environmental monitoring? If so, what strategies is your laboratory employing in order to detect unauthorized and/or unintentionally released LMOs? If not what are the barriers to adopting such a strategy?
At Mexico is developed a Laboratory Network of Detection, Identification and Quantification of GMOs. Inside this there are already methods of detection for ELISA, PCR and Real-time, but the restriction point is the events and constructs available information about the many different unauthorized and/or unintentionally released LMOs in order to be able to have a useful process. In the other side, there are some many events that the cost of perform a whole screening of them would be very high if you consider a big amount of samples. Into the laboratory network there is one that could use sequence detection methods, even next gen sequence process, for an screening or a confirmation LMO release, but this could be done just for a few specific cases (cost and resources), not like a general protocol.

Kind Regards.
Laura Tovar