3. Simplified procedures related to Article 13 and Agreements and arrangements as per Article 14

Challenges to Existing Frameworks
Living Modified Organisms (LMOs) present opportunities for current risk assessment frameworks to integrate gender-responsive and inclusive indigenous knowledge systems. This necessitates participatory mechanisms that recognize the differentiated impacts LMOs may have on women, indigenous peoples, and local communities. Formal and non-formal education systems ought to be co-designed to consistently integrate risk literacy on LMOs, to ensure that all populations are informed. Solutions lie in expanding frameworks to include localized, culturally grounded, and gender-responsive risk assessment practices that embrace both scientific and traditional ecological knowledge.
Specific Challenges:
 Inadequate capacity among women leads to a deficiency of technical capacity.
 Limited incorporation of indigenous early-warning systems and environmental indicators into risk assessment processes.
 Gender-blind impact assessments that account for economic and ecological dimensions with biodiversity.
 Limited public education strategies need to integrate local languages, oral traditions, or community-driven learning.
Specific Issues
 Some LMOs are in use globally, necessitating a harmonized gender responsive global response.

1. How does this topic potentially pose challenges to the existing risk assessment frameworks, guidance and methodologies? Do solutions exist?
Challenges:

Simplified procedures (Article 13) may bypass full risk assessment, creating concern about oversight and consistency.

Agreements under Article 14 can vary in stringency, potentially leading to uneven levels of protection.

The lack of detailed guidance on how to apply or evaluate such procedures creates uncertainty for regulators and stakeholders.

Transparency and traceability may be reduced when procedures are not subject to the Protocol’s standard documentation or decision-making timelines.

Solutions:

Develop clear criteria and guidance on the conditions for applying simplified procedures and recognizing agreements.

Ensure notification and public availability of such arrangements through the Biosafety Clearing-House.

Promote capacity-building to ensure Parties can assess the implications of entering such arrangements.

2. What could be the specific challenges related to this issue?
Risk of inconsistent application of biosafety standards across countries.

Limited public participation and access to information when agreements are made bilaterally or multilaterally without transparency.

Insufficient oversight mechanisms to evaluate the adequacy of the measures in Article 14 agreements.

Legal uncertainty when agreements conflict with national or international biosafety obligations.

3. What are the specific issues concerning this topic?
(i) Potential to cause adverse effects on biodiversity:
Yes. Simplified procedures or lenient agreements may overlook risks specific to vulnerable ecosystems or rare species, especially in importing countries.

(ii) Potential for deliberate or accidental introduction into the environment:
Yes. If documentation or risk assessment requirements are waived, LMOs may be released or imported without proper safeguards.

(iii) Potential to disseminate across national borders:
Yes. LMOs covered by bilateral/multilateral arrangements may move across borders without consistent regulatory review, increasing the risk of unintentional spread.

(iv) LMO commercialization and global use:
Yes. Many commercial LMOs are subject to bilateral trade agreements that may invoke Article 14, reinforcing the need for globally coherent standards and risk communication.

Ossama AbdelKawy
Egypt National Focal Point of the Cartagena Protocol
Microbiology and Biotechnology Professor, British University in Egypt
Research Professor, Egyptian Atomic Energy Authority
Science Advisor, Egyptian Ministry of Environment

Esteemed colleagues,

In contribution to discussion, I would like to comment on the suggested questions 1 and 3

1- From a risk assessment framework perspective, the main challenge in developing and implementing a simplified procedure lies in the increased workload imposed on Competent Nacional Authorities. These authorities must manage multiple procedural pathways, determine which procedure applies to a given case, and verify whether a simplified approach is appropriate for a specific Living Modified Organisms (LMO). Additionally, this complexity may hinder effective risk management and post-assessment monitoring.

3- The main concerns would be related to issues (i) and (ii). The implementation of a simplified procedure could introduce uncertainties, particularly regarding the proper implementation of risk management measures and the prevention of unintended or unauthorized uses of LMOs. Furthermore, as noted in question 1, the use of multiple regulatory pathways for different LMOs may complicate risk management and post-assessment monitoring. This complexity increases the likelihood of environmental releases of LMOs in contexts where such releases are not intended or appropriate, potentially leading to serious or irreversible adverse effects on biodiversity, including risks to endemic or rare species, unique habitats or ecosystems, and human health, particularly in areas of value to Indigenous Peoples and local communities.

Dear All,

My warm thanks to Ana Laura Mello and Anita Anthonysamy for also moderating this third round of discussions.

My name is Piet van der Meer. I am trained as a microbial ecologist and an environmental lawyer, and since 1986 I have conducted hundreds of risk assessments in regulatory context. Since the adoption of the CPB, I also provide training on risk assessment to government- and public research institutions, with the principles and methodology of Annex III as the starting- and endpoint.

About simplified procedures: in the same way as with the discussion on protection goals, a discussion on simplified procedures can help to reflect on the history and overall approach of biosafety systems.

The reason for establishing, on top of existing regulations, biosafety rules for LMOs and similar categories was that these organisms possess novel genetic combinations that do not occur in nature, and for which the existing systems may not be designed. That concept of ‘novelty’ can be found in the definition of LMOs of the CPB, in the GMO definition of the EU GMO rules, and in many national biosafety systems.
Those biosafety systems provide mechanisms to identify and evaluate potential adverse effects that those LMOs with novel characteristics may have on the conservation and sustainable use of biological diversity.

Those systems also provide possibilities to identify categories of LMOs that could be subject to simplified procedures or generic exemptions. The possibility of simplified procedures can be found in the CPB in the articles 10, 13 and 14. The possibility for generic exemptions of the AIA procedure, can be found in paragraph 4 of article 7 of the CPB, which states that the AIA procedure shall not apply to LMOs identified by the COPMOP as being not likely to have adverse effects. A similar approach can be found in many national systems and in the EU regulatory framework for GMOs (e.g. Recital 17: “This Directive should not apply to organisms obtained through certain techniques of genetic modification which have conventionally been used in a number of applications and have a long safety record”).

Simplified procedures established on the basis of gained experience and knowledge can help Parties make more efficient use of their regulatory resources and can help Parties focus on the scientific aspects of new cases.

I therefore support earlier suggestions that there is mileage in developing guidance to help Parties that are in the process of identifying categories of LMOs for which simplified procedures would be appropriate. Such guidance could, among other things, help Parties describe specific categories of LMOs, and help identify relevant experience and knowledge pertaining to those categories.

Regards to all,

Piet van der Meer

My gratitude to both Ana Laura Mello and Anita Anthonysamy for moderation. Greetings again to my colleagues.

1. How does this topic potentially pose challenges to the existing risk assessment frameworks, guidance and methodologies? Do solutions exist?

There is a problem with simplified procedures should they work by grouping LMOs based on hazard only (i.e. the information of Annex III paragraph 9 a-f). If so, then they fail to satisfy a grouping based on risk, which is achieved with the additional information called for in Annex III paragraph 9 g-h. This kind of information is used in the methodology described in Annex III paragraph 8.

It was on this point that a Federal Court in the United States in December 2024 vacated the earlier updates to biotechnology regulations [1]. Although the US is not a Party to the Protocol, the concept of risk equivalence from hazard equivalence applies in both contexts. The judge in this case noted a common misunderstanding of the finding by the US National Academies (NAS) that “the genetic engineering process, per se, presents no new categories of risk compared to conventional breeding”. The misinterpretation of this statement leads to scientifically unjustified conclusions such as acceptability of risk from LMOs when they by some measure appear to be the genotypic equivalent of an organism that might have arisen spontaneously or through conventional breeding. Another category of scientifically unjustified conclusion would be that a description of genotypic equivalence is sufficient to complete a risk assessment.

The judge summarised the first point quoting the NAS itself when it said that to assume that all risks of conventionally bred plants would be acceptable to society, and therefore so too would be potentially equivalent risks from LMOs, was "scientifically unjustified". Indeed in its 2016 report, the NAS said the opposite as in “even a small genetic change could lead to biologically important alterations of a crop, so it would not be possible to exempt plants with small genetic changes” [2]. Those are the kind of plants most often placed in the category of similar or indistinguishable from plants that might arise without the use of modern biotechnology.

The judge summarised this as “But that contention still takes the risk from conventionally bred plants as the baseline on which the scope of regulatory oversight should be defined, a premise the 2002 NAS study concluded is ‘not scientifically justified’…”. When we add to this the discussion of LMOs that are not plants, which was not part of the NAS consideration of the time, the point is even more dramatically made.

Beyond this, there is no use of modern biotechnology that is inherently only able to create outcomes equivalent to those arising without modern biotechnology regardless if intentions [3]. For example, according to the US Department of Agriculture Animal and Plant Health Inspection Service (APHIS), uses of SDN1, SDN2, and each or both in multiplex or sequential reactions, can create outcomes with no known equivalent in conventional breeding even if any single reaction might [4]. Consistent with the points made by colleagues such as in #12426, #12431, #12439, and #12443, cumulative changes to a species genome made possible by genome editing can produce LMOs that rapidly diverge from a conventional comparator and which may be incrementally describable in the same hazard class, but over time change risk categories.

Simplified procedures would still depend on adequate pre-release processes to confirm that the LMO was as it was intended to be, was a hazard equivalent to a non-LMO, and as well was of acceptable risk in the intended receiving environment. The solution already exists and it is the Protocol methodology.

2. What could be the specific challenges to related to this issue?

Failure to satisfy the requirements for a scientifically sound risk assessment.

3. What are the specific issues concerning this topic?
(i)
Yes

(ii) Is there the potential to have an introduction into the environment either deliberately or accidentally?
Yes

(iii) Is there the potential to disseminate across national borders?
Yes

(iv)
Yes

4.
The Protocol Annex III

1. National Farm Coalition et al. v Tom Vilsack et al. https://www.centerforfoodsafety.org/files/2024-12-02--ecf-81--order-re-summary-judgment_44232.pdf.
2. NASEM. (2016) Genetically Engineered Crops: Experiences and Prospects, The National Academies Press. https://nap.nationalacademies.org/catalog/23395/genetically-engineered-crops-experiences-and-prospects
3. Koller, F. and Cieslak, M. (2023) A Perspective from the Eu: Unintended Genetic Changes in Plants Caused by Ngt—Their Relevance for a Comprehensive Molecular Characterisation and Risk Assessment. Front. Bioeng. Biotechnol. 11.
4. https://www.federalregister.gov/documents/2024/11/13/2024-26232/movement-of-organisms-modified-or-produced-through-genetic-engineering-notice-of-additional

Dear colleagues,

Thank you all very much for your contributions and active participation over the past three weeks. We have generated invaluable input for the work of the AHTEG. You can submit comments until 4 p.m. (Montreal time) today.

Best regards

Ana Laura

Thank for the opportunity to participate and follow in this discussion.


Question 1:  How does this topic potentially pose challenges to the existing risk assessment frameworks, guidance and methodologies? Do solutions exist?

Articles 13 and 14 of the CPB offer flexibility that can help streamline notification (advance informed agreement) requirements for transboundary movements of LMOs while recognising any existing agreements and arrangements among Parties. Annex 1 in the CPB adequately outlines information necessary for this type of notification which includes previous and existing risk assessment reports consistent with Annex III.
The application of simplified procedures is founded on the principles of risk assessment, is based on scientific evidence and specifically applied to LMOs with a history of safe use in multiple environments, for which sufficient experience or data exists to conclude on the assessment.
Annex I does not negate the requirements for advanced informed agreement, transportation, labelling and packaging and the need for public awareness. Moreover, it promotes the use of regional risk assessments or mutual recognition agreements to support simplification.
There are Parties that have incorporated regulations on simplified procedures within their regulatory systems and this would serve as useful resource for experience sharing. In addition, there are examples of successful mutual and regional collaborative work that serve as good examples for mutual recognition agreements that support a simplified procedure. 

2. What could be the specific challenges related to this issue?

The lack of specific simplified procedure could lead to differences in the application of these articles by Parties. This can be addressed by adopting common information requirements as those outlined in the Protocol's Annex I, to ensure consistency even when procedures are simplified. The use of the Biosafety Clearing House for information exchange (Article 20) is critical for effective implementation.

3. What are the specific issues concerning this topic? (Potential to cause adverse effects on biodiversity, for deliberate or accidental introduction into the environment and to disseminate across national borders)

While the potential for harm, adverse effects or accidental introduction remains, Article 13 states that provided that adequate measures are applied to ensure the safe intentional transboundary movement of LMOs in accordance with the objective of the Protocol. The simplified procedure does not bypass the risk assessment process but rather, it acknowledges that previous risk assessments can be sufficient, particularly for LMOs for which comprehensive data and a history of safe use already exist.

4. Are there existing resources on similar issues that can address this issue or resources that could be adapted to address this need?

The existing risk assessment and management guidelines support the use of simplified procedures in cases where an LMO has been previously assessed, or sufficient experience exists. OECD Environment, Health and Safety Publications Series on the Safety of Novel Foods and Feeds No. 37 is a useful guidance document on considerations for collaborative work on assessments that can include simplified procedures.  It highlights initiatives that have been undertaken in Canada and New Zealand, South Asia and Economic Community of West African States (ECOWAS)

Hello,
1. How does this topic potentially pose challenges to the existing risk assessment frameworks, guidance and methodologies? Do solutions exist?

Article 13 on the Simplified Procedure does not directly present any challenges to the existing risk assessment framework, guidance, or methodologies. However, the Article does exhibit a degree of ambiguity that may impact its implementation. For instance, the use of the term "may" is non-committal and could result in importing parties perceiving that they are not obligated to submit information to the Biosafety Clearing-House (BCH). Additionally, Paragraph 1(b) lacks clarity, particularly regarding the exemption from the Advance Informed Agreement (AIA) procedure. This exemption could inadvertently bypass the opportunity to review relevant risk assessment reports, especially in cases where the transboundary movement of living modified organisms occurs simultaneously with notification to the Party of import.

Article 14 on Bilateral, Regional, and Multilateral Agreements, similar to Article 13, does not directly impact the process of risk assessment. However, there is a need for clear guidance outlining the essential elements that should be mandatory within such agreements. This is necessary to ensure that the level of protection afforded by these arrangements is not lower than that provided for under the Protocol.

My name is Eder Toppa, and I have been working for the Brazilian Ministry of Agriculture and Livestock for the past decade. I am currently the Head of the Biosafety Service and a member of the National Biosafety Commission.

Article 13 of the Cartagena Protocol has received limited implementation and engagement from Parties, unlike other articles that have been widely supported through various resources and initiatives. Consequently, its potential remains largely unfulfilled and unrealized.

The experience gained from assessing several traits or events (i.e., different LMO modifications) and the same event multiple times (i.e., repeated assessments of a particular LMO across different contexts) could be used as the basis for information sharing towards the implementation of Article 13. For example:"

- Leveraging Previous Assessments to Reduce Redundancy: Regulatory agencies have evaluated numerous LMOs with similar traits. If a trait has already been well-characterized in different genetic backgrounds and environments, new assessments could rely on existing data instead of requiring full new studies.

- Reassessment of the same event: If a specific LMO event has been approved in multiple regions and monitored for years without environmental or health adverse effects, regulators could use existing data and only require new country-specific studies in the case of new specific risk hypotheses. A practical example is the reassessment of the safety of certain GM events multiple times, consistently reaching the same conclusions. This accumulated experience could be used by other regulatory bodies to streamline approvals without redundant assessments

- Stacked Events: Different countries have varying regulatory requirements for stacked events, leading to inconsistencies in risk assessment. This lack of harmonization can result in trade barriers and confusion over safety standards, complicating the implementation of simplified assessments globally.

Best regards

Eder Victor Braganti Toppa
Federal Inspector
Head of the GMO Biosafety Service
Plant Health Department
Ministry of Agriculture and Livestock

Dear All,

Reading the recent contributions to this debate, I realise that guidance on simplified procedures would also benefit from some general introduction to simplified procedures, starting with a clarification that simplified procedures and exemptions are not unique to the Cartagena Protocol on Biosafety, but feature in many national biosafety regulations, and in fact feature in many regulatory frameworks in many different areas outside biosafety.

It will also be good to clarify what articles 10, 13 and 14 say.  For example, the term "may" in article 13 refers to the optionality of establishing simplified procedures, but it does not mean that specifying any such simplified procedures in the BCH is optional.

Last, but certainly not least, it will be important to clarify that, as Mutibo Chijikwa righlty noted in post #12562, the identification of categories of LMOs for which simplified procedures could apply is typically based on the risk assessment methodology and points to consider as outlined in Annex III, including the information listed I paragraph 9, points a through h.

As regards the points g and h of paragraph 9: the intended use is not only part of the risk assessment but is also often used as a qualifier, e.g. certain simplified procedures apply to – for example – specific confined field trails of specified categories of LMOs. The likely potential receiving environment mentioned in point h of paragraph 9 is taken into account in the same way as for risk assessments for the import of LMOs under the AIA procedure.

Regards

Piet van der Meer

Dear colleagues,

My name is Anita Greiter. I am an ecologist working at the Environment Agency Austria on biosafety issues since 2009. I am also BCH National Focal Point for Austria.
First, I allow me to thank the moderators for moderating the discussions and the participants of this forum for all the information provided.

Decision CP 11/7 relates to risk assessment and risk management. Para 8. “Invites Parties to submit detailed information on their needs and priorities for further guidance materials on specific topics of risk assessment of living modified organisms, including a rationale following the criteria set out in annex I to decision CP-9/13”.

Since the topic at hand refers to Articles 13 and 14 of the Cartagena Protocol it is unclear to me what the specific risk assessment topic would be and thus it seems out of scope of decision CP 11/7.

Thank you
Anita

Dear colleagues,

my warm thanks to our kind moderators, the Secretariat for facilitating it and the participants for valuable contributions.
My name is Dr Werner Schenkel, I have been working as a risk assessor for the German Competent Authority for about 20 years and have been involved in Cartagena Protocol related issues since 2017.

As Piet van der Meer has rightly pointed out (#12570), Article 13 opens up the option of establishing simplified procedures and combines this with the obligation to specify them in advance to the Biosafety Clearing-House. Both the option and the obligation are addressed to the individual Party of Import.
In my understanding, this also means that it is a matter of national/regional competence to specify simplified procedures, which does not necessarily require further international harmonisation.
It is also clear that there is no point in discussing whether or not simplified procedures should be developed or applied, as Article 13 is part of the CPB and therefore agreed between the Parties.

I think Anita Greiter made a good point when she questioned whether this issue fell within the scope of decision CP11/7 and the risk assessment and risk management item. So I am not sure that a decision on additional guidance on this issue could be reached in this process. However, as pointed out (#12567, #12562), the use of simplified procedures could have a practical impact on the work and workload of risk assessors. In particular, where resources are limited, it could help to focus efforts. I also agree (#12562) that this should not and does not mean bypassing risk assessment.
With this in mind, additional guidance could assist Parties in their national efforts to establish simplified procedures, thereby implementing another article of the CPB while promoting international harmonisation of such national procedures.

In my view, these ideas could be applied in a similar way to Article 14.

Kind regards

Dear participants,

Thank you again for the opportunity to participate in these discussions. I am representing developers of biotech crops that have experience with the regulatory requirements for commercialization.

The typical practice to obtain a regulatory authorization is for the developer to submit an application to the competent regulatory authority who then assesses it and makes a decision. The application addresses the notification requirements (per Article 8 of the Cartagena Protocol) and the regulatory data required by the authority to inform the risk assessment (Article 15, Annex III) that is the basis for their decision (Article 10). This process applies to the first transboundary movement of the LMO for intentional introduction into the environment and constitutes the “Advanced Informed Agreement” (AIA) procedure (Article 7).

As pointed out by others (#12563 and #12570) the “simplified procedure” provided for in Article 13 has some ambiguity. Our interpretation is that it enables certain LMOs to be exempt from the AIA procedure based on prior risk assessment(s) and accumulated knowledge by regulatory bodies. Article 13 asks that Parties specify applicable cases to the Biosafety Clearing House, and instead of the AIA procedure, a notification would be provided to the Party of import at the time of the first transboundary movement. There is information that shall be provided with the notification set out in Annex I.

The information requirements of Annex I have some commonalities with the Annex III risk assessment “points to consider” and notably includes “a previous and existing risk assessment report consistent with Annex III”. Prima facie this appears to have some overlap with the topic of regulatory data transportability in this online discussion series (week 3, topic 4), but extend this to a form of mutual recognition of existing risk assessments. However, this is unclear since Annex I also applies to notifications in the AIA procedure (per Articles 7 and 8).

We have contributed comments for the data transportability topic (#12576), and in principle support initiatives that leverage accumulated knowledge and experience, and existing regulatory data and risk assessments to streamline regulatory processes and reduce duplication and redundancy.

We note that the Cartagena Protocol does not preclude Parties from adopting simplified procedures, and national examples exist that are consistent with this (noted in #12549 and #12570). The sharing of information on relevant examples and their practical application could promote exchange of best practices and support work towards harmonized criteria. This could also support the implementation of Article 14 to give effect to simplified procedures.

Thank you for the interesting discussions. I am from the Third World Network and have been involved in biosafety discussions under the Cartagena Protocol on Biosafety for over two decades.

I agree with #12572 that the topic of Articles 13 and 14 appear not to be within the scope of the request in decision CP 11/7 for specific topics for risk assessment. In particular, a simplified procedure is not equivalent to a simplified risk assessment, and should not be confused as such.

Article 13 provides that Parties of import may apply a simplified procedure in two scenarios – where intentional transboundary movement may take place at the same time as the movement is notified to it, and where imports of LMOs to it may be exempted from the AIA procedure.

In both cases, this can only happen if the Party of import applies adequate measures “to ensure the safe intentional transboundary movement of living modified organisms in accordance with the objective of this Protocol”. Further, for the first case, the information provided in the notification “shall be the information specified in Annex I” – which in turn requires “a previous and existing risk assessment report consistent with Annex III”.

In the second case, this clearly operates at the domestic level only – i.e. it is only proposed imports of the specific LMO to the Party of import in question that are affected. Transboundary movements of the same LMO to all other Parties remain subject to the Protocol’s AIA procedure, which requires adherence to Annex I and Annex III.

Similarly, Article 14 provides that Parties may enter into bilateral, regional and multilateral agreements and arrangements regarding intentional transboundary movements of LMOS. This has to be “consistent with the objective of this Protocol and provided that such agreements and arrangements do not result in a lower level of protection than that provided for by the Protocol.”

Annex III therefore continues to provides fundamental guidance for the application of Articles 13 and 14, including to meet the conditions of “safe intentional transboundary movement” of LMOs “in accordance with the objective of this Protocol”, and to be “consistent with the objective of this Protocol” and not resulting in a “lower level of protection than that provided for by the Protocol.”

Thanks and kind regards.

Dear colleagues,
Let me begin by thanking the moderators and the Secretariat for facilitating this important discussion, and all participants for their valuable and thoughtful contributions.
The ongoing discussion on simplified procedures under Articles 13 and 14 of the Cartagena Protocol on Biosafety rightly highlights both their underutilization and their future potential. Building on previous posts, I would like to offer a few reflections based on the Protocol's intent. Simplified procedures, when appropriately applied, may be important not only for increasing regulatory efficiency, but also for enhancing biosafety—by enabling competent authorities to better allocate limited resources, reduce redundancy in regulatory processes, and focus attention where it is most needed: on higher-risk scenarios or cases involving greater scientific uncertainty.
Article 13 of the Cartagena Protocol allows Parties to apply simplified procedures for the transboundary movement of Living Modified Organisms (LMOs), provided that such procedures are consistent with the objective of the Protocol. However, simplification must not mean replace context-specific risk assessment, particularly where conditions warrant closer scrutiny. As outlined in the IUCN’s Explanatory Guide, Articles 13 and 14 are not intended to weaken biosafety safeguards, but rather to provide legally sound mechanisms for Parties to enhance efficiency and cooperation, while remaining transparent and aligned with the Protocol’s core provisions.
Similarly, the guide Understanding the Cartagena Protocol on Biosafety emphasizes that simplified procedures are designed to streamline decision-making for LMOs with known safety profiles, not to bypass risk assessment. It reinforces the importance of applying these provisions selectively, where scientific evidence supports a reduced level of regulatory scrutiny.
The PRRI overview further highlights how Articles 13 and 14 can facilitate international cooperation, especially through bilateral and regional arrangements. These mechanisms are particularly relevant where mutual recognition of risk assessments or harmonized regulatory practices can reduce duplication while maintaining biosafety standards.
As also well noted in post #12570, future guidance on simplified procedures would benefit from a general introduction, starting with the clarification that simplified procedures and exemptions are not unique to the Cartagena Protocol, but are also found in many national biosafety regulations and across various regulatory frameworks outside of biosafety. Recognizing this broader regulatory logic could help Parties develop fit-for-purpose mechanisms that preserve safety while improving effectiveness.
Importantly, it is worth recalling that the objective of the Cartagena Protocol, as stated in Article 1, is to contribute to ensuring an adequate level of protection in the field of the safe transfer, handling and use of LMOs, while taking into account risks to human health, and in a manner that protects biodiversity and supports the responsible use of modern biotechnology.
Given the accumulated experience with certain LMOs, I believe we are now in a better position to:
• Clarify criteria for simplified procedures based on Annex III, including paragraph 9;
• Support the development of practical guidance to assist Parties in identifying and describing LMO categories appropriate for simplification;
• Promote greater notification and sharing of simplified procedures through the Biosafety Clearing-House (BCH);
• Reduce redundancy in regulatory efforts while maintaining high biosafety standards.
In summary, these provisions offer important but underused opportunities to enhance implementation of the Protocol. With increasing familiarity, regulatory experience, and available data, this may be the right moment to revisit their application.
Kind regards, Lúcia

References
1. IUCN (2003). An Explanatory Guide to the Cartagena Protocol on Biosafety. IUCN Environmental Law Centre. https://portals.iucn.org/library/efiles/documents/eplp-046.pdf
2. GEAC India (n.d.). Understanding Cartagena Protocol on Biosafety: A Guide. https://www.geacindia.gov.in/resource-documents/14-Understanding_Cartagena_Protocol_on_Biosafety_A_Guide.pdf
3. PRRI. Overview of the Cartagena Protocol on Biosafety. https://prri.net/cartagena-protocol-biosafet

Dear All,

Following up on the valid question raised Anita Greiter (#12572), Werner Schenkel (#125800) and others whether this topic falls under the COPMOP decision: I believe that it does. Identification of categories of LMOs that could be subject to simplified procedures or exemptions is based on risk assessment, and this topic is suggested by a party as possibly benefitting from guidance materials to support such risk assessment.

That said, I fully agree with Anita Greiter that not everything mentioned in this on-line forum falls under the scope of the CPB, such as references to jurisprudence in non-Parties.

Good weekend to all!

Piet

Dear Participants,

Thank you very much for your active engagement over the past weeks of the Open-Ended Online Forum on Risk Assessment. The Secretariat will work hard to synthesize your important insights and inputs for the Ad Hoc Technical Expert Group.

The final week of the online forum is now closed.

Kind regards,

The Secretariat