Online discussions on socio-economic considerations

Participants are invited to provide general comments on methodologies and applications of socio-economic considerations as raised in the submissions.

I would like to point out that - despite some environmental concern on Rapeseed in Norway - many of the SE considerations lie outside the scope of Article 26 (a concern raised by Brazil, South Africa, New Zealand & USA in their submissions).  In other words, these SE considerations are NOT arising from potential or real impacts to the conservation and sustainable use of biodiversity.

A clear example is the comment from Nigeria (#9881, in the Norway thread) where their National Biosafety Framework outlines SE considerations DIRECTLY arising from the use of GMOs (changes in pattern of SEs; socio-cultural conflicts with GMOs, although their last point does relate to threats to biodiversity etc). South Africa, I have previously noted, has a similar approach. 

However, the focus of CBD and its Cartagena Protocol is on conservation & sustainable use of biodiversity.  Article 26 also focuses on impacts to conservation & sustainable use, and much of the discussion we are having is thus beyond the scope of Article 26.  The Guideline document is not intended specifically to evaluate SE issues arising from the use of LMOs - rather its focus should be defined in a problem statement (potential or real impact to conservation & sustainable use of biodiversity, and resulting SE effects), and unfolding options on a way forward to determine such effects.

It is a sovereign decision for each country to elaborate more comprehensive SE considerations, but these should be consistent with international law & other agreements.  As per the South African submission, there remain some concerns with the guidance document as it currently stands: with relation specifically to focus on Article 26.

Ben

It is important as we highlighted this issue of SECs in line with CPB. However I wish to make a case of reality.
While Nigeria agrees that any socioeconomic issues considered in decision making regarding LMOs should have its effects traceable  or linked to the conservation and sustainable use of biological diversity consistent with Article 26 of CPB, it's important to note that in real sense, socioeconomic issues are not always and usually scientific hence, I am of the personal opinion that countries could go beyond Article 26 to handle socioeconomic issues consistent with their national legislation as far as it doesn't contradict  Article 26.

Onyeka Nwosu

Thanks for your comment (9905), Onyeka (on the reality of scope 'creep' under Article 26).

Contrary to Onyeko, I am of the view that we SHOULD clearly separate what is covered by CPB and what is not (even though Article 26 is voluntary).  This is for two principle reasons:

1. Allowing subjective interpretation and using the CPB to justifying non-related issues will undermine the protocol, and eventually render the CPB toothless and useless(!).

2. The CPB, like its parent convention (CBD) is focused on the environment, and specifically on the conservation & sustainable use of biodiversity. This particularly so as it is very largely human population growth and human encroachment and human-induced climate change that is so threatening to our planet's biodiversity (and ultimately to human existence). Hence we are for once saying - in the CBD and CPB - that the environment comes first (i.e. make sure your use of biodiversity is sustainable), and while risks to human health are clearly considered along with environmental risks, in Article 26 we consider 'people' issues only if we determine there are risks to the environment.

The point is that countries have the sovereign right to 'protect' their people, to develop laws that safeguard the health and well-being of their people.  The CPB is not expressing a view on how governments should do this.  Rather what it is saying (in my view) is that if there is a risk to the environment, be very clear on how these impacts may (also) affect people, their livelihoods, their culture, etc. (To paint a scary scenario - surely we would not want short-term benefits to humans to outweigh the impacts to biodiversity, because in the long run we will also be affected).

Ben

Dear all
it is important to bear in mind that Socio-economic considerations in the Cartagena Protocol on Biosafety are rooted in its parent treaty, the Convention on Biological Diversity. Both the CBD and CPB, as legally biding international instruments, must be implemented in a complementary and consistent fashion. Article 26 of the CPB has broad language that justifies the right of Parties to consider socio-economic issues when taking a decision on import of LMOs.

Under the CBD Aiming to reach its objectives, Articles 7 to 10 establish clear and mandatory biosafety and socio-economic provisions for Parties:

• Article 7 establishes the mandate, in particular for the purposes of Articles 8 - 10, to establish a system for identification and monitoring of components of biological diversity that are important for its conservation and sustainable use. In addition, to identify and monitor the effect of processes and categories of activities, (which would include modern biotechnology), which have or are likely to have significant adverse effects on the conservation and sustainable use of biological diversity. An indicative list, clearly including socio-economic aspects, of categories of components of biological diversity to be considered is set out in Annex I.
• Article 8(g), together with Articles 19(3) and 19(4), relate to living modified organisms (LMOs), and gave origin to the Cartagena Protocol on Biosafety. It implies that Parties should establish or maintain means to regulate, manage or control the risks associated with the use and release of living modified organisms resulting from biotechnology and are likely to have adverse effects on the conservation and sustainable use of biological diversity, taking also into account the risks to human health.
• Article 8(j) provides that Parties need to put in place measures to: i) respect, preserve and maintain the knowledge, innovations and practices of indigenous and local communities relevant for the conservation of biological diversity; ii) promote their wider application under the approval and involvement of the corresponding knowledge holders; and iii) encourage equitable sharing of benefits arising from the use of biological diversity.
• Article 10 specifically provides for the sustainable use of the components of biological diversity. Both “sustainable” and “use” are intrinsically socio-economic issues  in themselves, captured by specific elements - such as protection and encouragement of customary use, consistency with traditional cultural practices – spelt out in the CBD´s Article 10.

it is important also to highlight that The CPB, as any other protocol, is related to its parent treaty, the CBD, through substantive, procedural, and institutional links; accordingly, it must comply with the Convention’s provisions when implemented. Moreover, Parties to the Protocol have to also be Parties to the CBD (Article 32 of the CBD). Thus, the CPB cannot be read separately from the CBD, but in conjunction with each other since the Protocol implements the Convention.

O.A.El-kawy

Stuart Smyth (#9886) has commented "With science-based risk assessment methodologies already structured and functioning that examine risks to the environment and human health, it would seem an inefficient allocation of resources to review the socio-economic aspects of the two topics."

South Africa agrees with this comment - we would be very unlikely to permit the release of a LMO where the risk assessment indicates possible/probable negative impacts to the environment (beyond conventional agriculture).  So a SE study to determine impacts to humans - although a voluntary option as per Article 26 - is moot and purely academic.

However, there are examples where such a study may be gainfully employed: take the example of a mosquito with a gene drive (eg. designed to eradicate the mosquito).  There would be/is a biodiversity impact, and a socio-economic study to determine if there are only benefits to be had from such an action, or whether there may be broader biodiversity & SE impacts, may be called for.  However, as per the Norwegian submission, it is also possible that there is sufficient information already available to make such a decision.

Ben

Gene Drives raise new concerns and issues. It is a new technology and the questions on applying SE considerations and governing them as LMOs are yet to be addressed fully. In my view in case of Gene Drives, the typical EIA will not be sufficient. In this regard the observations of the NAS report are very relevant. Some of these addressed in the forthcoming volume
Socio-Economic Impact Assessment of Genetically Modified Crops
https://www.springer.com/gp/book/9789813295100

As gene drives can have transborder impacts issues of sovereignty and protecting ecosystems and biodiversity are very relevant. The challenge lies in developing guidelines and frameworks that facilitate SE Assessment and integrating SE considerations in decision making.

Krishna Ravi Srinivas

Thanks, and well aware that there are substantive differences between 'normal' LMO's and gene drives which will require different RA processes and at least regional coordination. I was merely illustrating that there are potential circumstances where a SE consideration may be invoked as per Article 26 (i.e. having impacts to biodiversity which only then are considered for SE effects).

Ben

Transborder impacts are important considerations as studies have shown the significance of spillover benefits from the adoption of GM crops. In the USA, Hutchinson et al. 2010 (https://science.sciencemag.org/content/330/6001/222.abstract) found that of the $6.8 billion in economic benefits of GM crops accruing to farmers, $4.3 billion (63%) went to farmers growing non-GM corn. Similar evidence is reported from China with the adoption of Bt cotton and area wide suppression of boll weevil populations, reducing chemical applications for non-Bt cotton farmers (https://link.springer.com/article/10.1007/s11427-010-4036-y). In some non-Bt cotton fields the amount of insecticide in kilograms per hectare dropped from in excess of 40 to less than 10. Across the entire sample region insecticide applications dropped from 14kg/ha to 4kg/ha.

The application of SECs that quantify the environmental and economic spillover benefits of LMOs will enhance the clarity of decision makers.

Stuart Smyth
University of Saskatchewan

First of all, I would like to thank the Secretariat for organizing this forum on such an important and sensitive topic, and giving us the opportunity to participate.

Taking into account the experience in each country, I would like to mention that in Argentina, within our regulatory framework, we contemplate an analysis of productive-commercial impact (Res. SAGYP 510/2011).

In the case of Argentina, the study of productive-commercial impact is conducted separately from the biosecurity analysis. It is an evaluation that, due to its characteristics, is different and independent of the biosafety evaluation. For example, it is carried forward by economists, sociologists, etc.

The study conducted by Argentina includes (among another things):
-The current status and the projections to produce, use and consume the GM product in the main domestic and foreign markets;
-Description of specific requirements related to the production and use of the GM Plant;
-Identification of the commercial risks connected to the commercialization of the GM Plant that may affect the primary producers, the productive chains and /or the national exports;
-Expected quantitative and qualitative benefits of the GM Plant for the producer, the productive chain, the consumer and/or the agroecosystem involved when compared to the available alternatives.

Something we would like to mention is that we see some concern in developing guidelines for the evaluation of socio-economic considerations. Not because it doesn't seem like a relevant issue, but for different reasons.

For example, we see with concern that some of the elements in the guidance go beyond the scope of Article 26. We are worried about the precedent that this may set for future discussions.

And taking into account that the elaboration of the risk assessment guide took a long time, many discussions, without becoming clear or simple enough for those countries that lack of regulatory experience, we believe that we should pay special attention to avoid that this possible guideline of socio-economic considerations could make it more difficult and complex for countries to asses LMO.

Because, if you want, or you need to use Biotechnology, to asses GMO, you have to do it with a strong and modern regulatory framwork. A Good regulation is the key for development of this kind of activities, in a safe way, preserving the natural resources.
We must be careful not to generate unnecessary confusion, and provide help to those countries that want to make safe use of this technology.

Thank you in advance!

Cecilia.-

I am Fernanda Lovato, from Brazil and I would like to thank Secretariat for the opportunity to share experiences among countries envolving this important issue.
Considering the general comments, as Ben (South Africa) and Cecília (Argentina) had already mentioned, I agree that the majority of SE considerations posted at this forum is outside of the scope of the Article 26, i. e., the examples are not arising from potencial or real impacts to the conservation and sustainable use of biodiversity.
As a former member of the brazilian National Biosafety Commission and according to the brazilian  biosafety legislation, I can inform you that the impacts to the conservation and sustainable use of biodiversity are partially evaluated during the regular GMO risk assessment at the moment we evaluate in details the potential damage to the environment, animals, microorganisms.
The real impact of any aspect (socio, economic, ethical, religious) to the conservation and sustainable use of biodiversity must be measured somehow. If we consider that these impacts are important for the risk assessment they need to be measured or calculated using a scientific method  basis. On the other hand, if we can´t estimate or calculate it will not be useful for the purpuse of SEC guideline.
In fact, the brazilian GMO risk assessment is based on Codex Alimentarius guideline and is in according to the SPS Agreement.
Best regards,

Thank you for posting and raising this concern Fernanda. I share your concern. Many SECs fall outside of the scope of Article 26, contravening the Article's requirement that SECs must be "consistent with international obligations".

Norway has raised the importance of the WTO and the SPS Agreement, whose definitions and rules require compliance. The SPS Agreement is structured so that Codex, the Office International des Epizooties (OIE) and the International Plant Protection Convention (IPPC) provide the technical standards for the SPS framework. In this instance, it is the IPPC that provides the technical compliance requirements for SEC clarity.

The IPPC is a multilateral treaty that seeks to protect natural flora, cultivated plants and plant products from the spread of pathogens through international trade. Through collaboration between regional and national plant protection organizations, it provides a forum for international cooperation, dialogue, harmonization and technical exchange of plant information. The IPPC has addressed the regulation of biotechnology and genetically modified crops though several of the International Standard for Phytosanitary Measures (ISPMs).

To determine the relationship between SECs and the IPPC, one needs to look to the IPSMs. There are 24 different ISPMs, none of which provide an allowance for SECs (http://www.fao.org/3/a0450e/a0450e00.htm).

The SPS Agreement of the WTO is an existing international obligation that Parties to the CPB need to remain compliant with, when it comes to the inclusion of SECs. The technical focus of the IPPC's ISPMs provides significant clarity as to the scope of SEC application.

Stuart Smyth
University of Saskatchewan

Thanks, Stuart, for an insightful comment (#9900), and providing more information on the international agreements issue, which the guidance document is at pains to emphasise that alignment is critical(!). 

However I'm not sure I quite agree with your comment "There are 24 different ISPMs, none of which provide an allowance for SECs..."

In the "IISPM No. 2;  point 2.2.3. Guidelines for pest risk analysis" for example, it looks at socio-economic impacts including an assessment of:
-  type of damage
-  crop losses
-  loss of export markets
-  increases in control costs
-  effects on ongoing integrated pest management (IPM) programmes
-  environmental damage
-  capacity to act as a vector for other pests
-  perceived social costs such as unemployment.
These are all relevant to our discussion.

I'm not sure if ethics is anywhere raised (?), but I tend to view the Norwegian position - which is strongly based on ethics - as something that may confound the courts (although I am not a lawyer).

Ben

Thanks  Ben for highlighting the ISPM No 2 guidelines which clears pinpoints socioeconomic areas of our discussion and I agree with you. Looking at one or two points critically,  it is to some extent in conformity with Cartagena Protocol on Biosafety stipulation for SE consideration which looks at the conservation and sustainability of biodiversity.
As regards the issue of Ethics, I think ethical considerations remains part of the difficulty in SE consideration as its most a times consider diverse culture, location and internal laws in an ambiguous manner. Interestingly, most country has devised a workable measure for ethical consideration of LMOs just like Norway.

Ben
The compatibility between CPB and SPS Agreement and CPB and WTO regulations attracted much attention after CPB was ratified. This should be understood in the broader context of debate on trade (WTO) and environment (various treaties/Conventions). As far as I know, there is no case before WTO on  CPB &SPS Agreement, On the other hand, exceptions in WTO Agreement on account of morality and public ordre  are narrow. So if ethics has to be invoked it has to be done indirectly and such an invocation/exemption has to be justifiable.
It also depends on how narrow/broad the SECs under the respective national regulations.
krishna ravi srinivas

Thanks for this interesting discussion.

With regard to consistency with international obligations, Principle 1 of the “Guidance on the Assessment of Socio-Economic Considerations in the Context of Article 26 of the Cartagena Protocol on Biosafety” reiterates this point, and also highlights that these include, “inter alia, trade agreements, environmental agreements and human rights agreements.”

The CBD Secretariat commissioned a study on international agreements that may have relevance to socio-economic considerations as provided for in Article 26 of the Cartagena Protocol on Biosafety, as requested by the Parties in Decision BS-VII/13. That study is available here: https://bch.cbd.int/onlineconferences/portal_art26/resources2015-2016.shtml

On the International Plant Protection Convention and the International Standards for Phytosanitary Measures (ISPMs) that it adopts, the study highlights ISPM 11 (https://www.ippc.int/static/media/files/publication/en/2019/05/ISPM_11_2013_En_PRA_QPs_2019-04-30_PostCPM14_InkAm.pdf), which specifically integrates standards for the pest risk analysis of LMOs. ISPM 11 therefore includes guidance on evaluating potential phytosanitary risks to plants and plant products posed by LMOs.

Section 2.3 of ISPM 11 is on “Assessment of potential economic consequences”. This is clearly a socioeconomic consideration, so I do not agree with #9900 that the ISPMs do not provide an allowance for socioeconomic considerations. Direct and indirect effects of pests may be considered, and the examples of indirect effects that are given in Section 2.3.1.2 of ISPM 11 include “effects on domestic and export markets, including in particular effects on export market access”, “changes to domestic or foreign consumer demand for a product resulting from quality changes”, and “social and other effects (e.g. tourism)”.

The WTO’s SPS Agreement, which specifically recognizes the IPPC as the international standard setting body for plant health, in Article 5.3 states: “In assessing the risk to animal or plant life or health and determining the measure to be applied for achieving the appropriate level of sanitary or phytosanitary protection from such risk, Members shall take into account as relevant economic factors: the potential damage in terms of loss of production or sales in the event of the entry, establishment or spread of a pest or disease; the costs of control or eradication in the territory of the importing Member; and the relative cost-effectiveness of alternative approaches to limiting risks.”

Finally, I’d like to highlight a publication from Third World Network which discusses many of these issues: “Socio-economic Considerations in GMO Decision-Making: International Agreements in Context” (http://www.twn.my/title2/books/Socio-economic%20Considerations%20in%20GMO%20Decision-Making.htm)

kind regards
Lim Li Ching
Third World Network

Article 26 is very explicit in that any SEC included in a LMO assessment has to comply with the party's commitments to the WTO and its SPS Agreement. ISPM 2 is also very explicit in the clarity it provides, stating, "For potential economic importance to be expressed, a pest must become established and spread." This clearly establishes that economic loss can be quantified from pest damage once it has occurred and as the ISPMs and SPS Agreement establish, this can only be undertaken once damage is measurable, there is no allowance under the IPPC's ISPMs for application as part of an ex-ante LMO assessment.

Similarly, ISPM 11 explicitly refers to "identification and characterization' of quantifiable economic damage. As is clearly articulated in 2.3.3, "Wherever appropriate, the output of the assessment of economic consequences described in this step should be in terms of a monetary value. The economic consequences can also be expressed qualitatively or using quantitative measures
without monetary terms." ISPM 11 provides further clarity that assessments are ex-post assessments and not allowed to be part of an ex-ante assessment, involving multitudes of hypothetical scenarios.

Stuart Smyth
University of Saskatchewan

Thanks Ben, this is an excellent question that helps to increase the clarity of Article 26.

Being a science-based organization, the IPPC makes it clear in ISPM 2 that this refers strictly to economic costs. The flow chart provided in subsection 2.1, illustrates a very clear and articulate risk analysis assessment protocol that has to be followed to quantify any economic loss arising from pest damage. ISPM 2 also refers specifically to pest damage that can be economically measured using detailed mathematical formula, based on ex-post assessment. There is no allowance to use ISPM 2 as part of an ex-ante assessment. I think this is where the clarity is greatly valued, in that there are rigourous science-based methodologies capable of measuring any economic lost resulting from pest damage. As ISPM states, "For potential economic importance to be expressed, a pest must become established and spread." This clearly identifies that economic damage can only be calculated ex-post and is not eligible to be used as a barrier to commercializing LMOs.

Stuart Smyth
University of Saskatchewan

Most trade related agreements establish an ultimate and crosscutting objective of remarkable socio-economic nature: Human wellbeing. Among international treaties, consistency with the World Trade Organization’s (WTO) agreements has been of particular concern. Yet, the General Agreement on Tariffs and Trade (GATT), the Agreement on Technical Barriers to Trade (TBT) and the Agreement on the Application of Sanitary and Phytosanitary Measures (SPS) under the WTO umbrella do not prevent the application of socio-economic considerations to justify a measure; on the contrary, they are valid so long as they are formulated with the appropriate justifications, defendable under available information, consistent with national regulations and do not lead to arbitrary or unjustifiable distinctions (WTOa n.d; WTOb n.d.). The fulfillment of these conditions arguably make socio-economic considerations on biosafety WTO-consistent. an ultimate and crosscutting objective of remarkable socio-economic nature: Human wellbeing. Among international treaties, consistency with the World Trade Organization’s (WTO) agreements has been of particular concern. Yet, the General Agreement on Tariffs and Trade (GATT), the Agreement on Technical Barriers to Trade (TBT) and the Agreement on the Application of Sanitary and Phytosanitary Measures (SPS) under the WTO umbrella do not prevent the application of socio-economic considerations to justify a measure; on the contrary, they are valid so long as they are formulated with the appropriate justifications, defendable under available information, consistent with national regulations and do not lead to arbitrary or unjustifiable distinctions (WTOa n.d; WTOb n.d.). The fulfillment of these conditions arguably make socio-economic considerations on biosafety WTO-consistent.

The attached file includes relevant legally binding treaties agreements including socioeconomic considerations that may be taken into account when implementing Article 26.1 of the CPB

O.A.El-kawy

Thanks for this comment (#9897) outlining the Argentinian experience!  I would like to ask if the study of productive-commercial impact is undertaken on a case-by-case basis or a more general review (as per China's submission), and how the study of productive-commercial impact feeds back into the decision-making process?

Ben

I agree with this view. We need more case studies and comparative analysis on how countries have adopted Article 26.1
klrishna ravi srinivas

It is a pleasure to join the online forum on Socio-Economic Considerations. Forum 1 has as scope, a discussion on experiences and studies in considering SEC in reaching a decision on import under the Cartagena Protocol and measures adopted to implement it.

Before entering into the cases, I would like to remind that the mandate of Article 26 of the Cartagena Protocol expressly states that socio-economic considerations must arise from the impact of living modified organisms on the conservation and sustainable use of biological diversity and should be consistent with international obligations from the Party that decides to adopt any such measures.

The link between a possible SEC with impacts of a determined LMO to biodiversity is a sine qua non condition to trigger measures adopted by a Party to the Protocol. In this sense, it is quite relevant to stress that the operational definition of SEC, as per the Guidance contained at the ATHEG Report (CBD/CP/SEC/AHTEG/2017/1/3), does not necessarily imply and/or require a causal link between SEC and biodiversity impacts caused by an LMO.

Moreover, the definition was not agreed by the Parties at a Meeting of the Parties, otherwise, was simply assumed as an agreed concept by the ATHEG, as a manner to fundament the work towards creating the proposed Guidance.   

It sounds the voluntary Guidance goes beyond Article 26 mandate, as stressed by Brazil in response to Notification 2019-031.

The fulfillment of international obligations is, in fact, a second formal obligation arising from Article 26 and on that regard, it is crucial to see the interlink between LMOs – SEC – Decision on import - Transboundary movement as issues regulated under the Agreement on the Application of Sanitary and Phytosanitary Measures (SPS Agreement) of the World Trade Organization and the Cartagena Protocol.

At the WTO, Members can adopt measures to prevent damages and impacts of LMOs if there is sufficient scientific evidences that justify such measures. Even precautionary measures can be adopted during a reasonable period-of-time if risk assessment and scientific evidences are in place to justify it. The rationale behind precautionary approach is exactly the need to search for information/scientific evidences regarding the measure at issue.

In this regard, I would like to support the message sent by Mr. Ben David Durham, from South Africa (thread #9888).

The French submission, used as a case to this Forum 1, for instance, states that the High Council for Biotechnology approach towards SEC considers the principles contained at the Voluntary Guidance, for example, “socio-economic analysis lies as much in the process of learning and dialogue that it encourages among stakeholders as in the end product, in accordance with Principle 7 in document CBD/CP/SEC/AHTEG/2017/1/3 (p. 9).”

Each Party can adopt SEC measures as per Article 26, and should, therefore, have a clear and objective link of the measure with impacts caused by the LMO to the biological diversity. Moreover, the SEC measure would need to balance scientific evidences when it comes to the SPS Agreement and, more specifically the Codex Alimentarius standards towards biotechnology.

In this sense, I would like to support the message posted by Stuart Smyth, from Canada (thread #9886).

The Norway case presented requires balancing the benefit to society and ethical considerations indicators in parallel of the scientific and sound risk assessment comprising human health and environmental indicators. The weight ethical and societal benefits can be scientific assessed and measured relies on subjective and even theoretical assumptions what must be balanced given the clear mandate of Article 26 of the Cartagena Protocol.

It is worth noting that SEC could also be addressed on non genetically modified products. It is not necessarily because a product is genetically modified and is an LMO that it triggers possible socio and economic considerations, especially when it comes to indicators that cannot be scientifically addressed. In this regard, conventional products could pose possible SEC as well. This is quite relevant when it comes to the casual link of SEC to biodiversity impacts as stated on Article 26.

It seems extremely important, at this point, that Parties have in mind the concept of damage and significant from the Nagoya-Kuala Lumpur Supplementary Protocol on Liability and Redress:

“Article 2.2(b): “Damage” means an adverse effect on the conservation and sustainable use of biological diversity, taking also into account risks to human health, that:

Is measurable or otherwise observable taking into account, wherever available, scientifically-established baselines recognized by a competent authority that takes into account any other human induced variation and natural variation; and

Is significant as set out in paragraph 3 below;”

“Article 2.3: A “significant” adverse effect is to be determined on the basis of factors, such as:
a. The long-term or permanent change, to be understood as change that will not be redressed through natural recovery within a reasonable period of time;
b. The extent of the qualitative or quantitative changes that adversely affect the components of biological diversity;
c. The reduction of the ability of components of biological diversity to provide goods and services;
d. The extent of any adverse effects on human health in the context of the Protocol.”

I hope this can contribute to the debate on SEC.

Thank you for the opportunity to participate in this forum.  I am a regulator at the U.S. Environmental Protection Agency (EPA), and I am responsible for assisting in regulatory determinations for a subset of genetically engineered organisms that contain plant incorporated protectants (PIPs) that are engineered via recombinant DNA techniques.  At the EPA, this regulation falls under the U.S. law known as the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA).  For more information about how U.S. federal government agencies coordinate to regulate biotechnology products, please see:

https://www.epa.gov/regulation-biotechnology-under-tsca-and-fifra/update-coordinated-framework-regulation-biotechnology 

For information on EPA’s role, please see:

https://www.epa.gov/pesticides/biopesticides

FIFRA is a “risk-benefit” statute that requires the EPA to evaluate certain products and consider whether there are “any unreasonable risk to man or the environment, taking into account the economic, social, and environmental costs and benefits.”  In laywoman’s terms, this means that the EPA must consider the potential risks of certain products, the potential ways to mitigate those risks, the potential benefits those products may pose, and balance our regulatory decisions in a manner that minimizes risk and maximizes public benefit. 

To consider potential risks, the EPA conducts a science-based risk assessment using strict scientific standards and extensive input from academia, industry, other Federal agencies, and the public (more details at the above links).  After completing a science-based risk assessment, for cases where a product is determined to not pose unreasonable risk to human health and the environment, EPA issues a regulatory approval and the product is allowed to enter into commerce.  If a potential risk is identified, the EPA defines risk management approaches for how to address any potential risk.  It is during this risk management phase that EPA considers economic, social, and environmental costs and benefits, and we use the risk management phase to balance risks and benefits before making decisions. 

To date, this is how the EPA has approved every commercially available product in the United States that contains a genetically engineered plant incorporated protectant.  The existing examples of this type of product available on the market to date largely fall within the Cartagena Protocol’s definition of an ”LMO”.  To see a list of these approvals, you can visit: 

https://www.epa.gov/ingredients-used-pesticide-products/current-and-previously-registered-section-3-plant-incorporated