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Thomas P. Redick
GEEC, LLC
Clayton, MO
www.geeclaw.com
MSU Biosafety
East Lansing, MI
July 31, 2013
 Negotiation History
Requirements of the
Supplementary Protocol
Relationship to Cartagena & CBD
Other liability treaties success-
failure
Summary and Issues to Consider
Going Forward
• 1996 Ad Hoc Open-Ended Working Group
on Biosafety meeting in Aarhus Denmark
• “One-pager” refers to Article XIV of CBD
“Examine Issues”
• G-77/China insisted on liability being
part of protocol; Africa most insistent
• Argentina parted ways with G-77/China
• Divisive issue when Protocol was being
negotiated – continued to be contentious
and controversial for 15 years.
• 2000 - Cartagena Protocol postpones it --
Article 27 says to hold future negotiations
on the topic
• “The [COP] shall, at its first meeting,
adopt a process [for]
• Elaboration of international rules and
procedures in the field of liability and
redress for damage,
• Resulting from transboundary movements
of LMOs,
• Analysing and taking due account of the
ongoing processes in international law on
these matters, and shall …
• Complete this process within four years.”
• Numerous discussions at international
meetings related to Protocol
• February 2004,COP-MOP 1 appoint Ad
Hoc Expert Working Group.
• Expert Working Group met 5 times
from 2005-2008.
• Friends of the Chair working groups
further refined issues (“contact
groups”) resolving contentious issues.
• Last two meetings – Kuala Lumpur
and Nagoya – gave NKLSP its name.
• Final text approved in Nagoya in 2010
at Cartagena Protocol COP-MOP 5.
 Binding supplemental protocol
 Administrative procedures to address
damages to biological diversity from
LMOs, rights belong to governments
 Civil liability also binding or just
guidelines?
 Meet the objectives of Article 27 and
CBD Article 14, Rio Principle 13
 Compact from Seed Industry played a
key role in brokering reasonable
compromise – standing ovation
 Administrative procedures to address
damages to biological diversity from
LMOs – Governments will enforce
 Private civil liability not made
binding.
 Meet the objectives of Article 27
without imposing undue burdens on
innovation in agricultural
biotechnology and grain trade.
 “Damage” is significant adverse effect on
the conservation and sustainable use of
biological diversity - measurable taking into
account scientifically established baseline
 Baseline requires inventory of species-
habitats that could take years to adequately
compile.
 International liability precedent of Canada-
US “Trail Smelter” case and NKLSP defined
“significant” as:
 Long term or permanent change not redressed
through natural recovery
 Qualitative and quantitative changes adversely
affecting components of biological diversity
 Reducing ecosystem/biodiversity goods/services
 First multilateral environmental
agreement to define damage to
biodiversity
 Example – Chinese native rice displaced,
lost to future generations of valuable
genes?
 Confirmation of value of genetic resources
and need to protect them from all threats
(even if this is just one of many threats)
 Industry recognized long-range value of
protecting the genetic resources that
modern plant breeders rely upon.
 Biotech seed industry’s innovative power
imparts additional value to the genetic
resources in wide range of species (even
microbes).
 1992 Convention on Biological Diversity
objectives: 1) conservation, 2) sustainable
use, and 3) equitable distribution of
benefit and “appropriate access to genetic
resources”
 CDB Art. 14 suggested that the parties
“examine the issues” of liability, except
where internal issue.
 Rio Principle 13 has similar suggestion.
 Cartagena Protocol on Biosafety must
serve objectives of CBD.
 Cartagena Protocol on Biosafety, ten years
after its text, created a text on liability.
“Reasonable actions to:
 Prevent, minimize, contain, mitigate, or otherwise
avoid damage, as appropriate’
 Restore biological diversity through actions to be
undertaken in the following order of preference:
 Restoration of biological diversity to the condition
that existed before the damage occurred…
 “Restoration by replacing the biological diversity
with other components of biological diversity for
the same or for another type of use either at the
same or, as appropriate, at an alternative
location.”
 “Where relevant information … indicates
there is sufficient likelihood that damage
will result if timely response measures are
not take, …”
 Examples – chemical storage tank in bad
condition and likely to leak or started
leaking and is likely to migrate to water
body; tank is leaking, enters aquifer but
damage is not significant yet.
 Oil Spill in Gulf of Mexico -- oil leaking
before damage to birds, beaches, etc… but
only a matter of time (need to respond)
 Parties can require operators to take certain actions in
the event of damage
 Inform the competent authority
 Evaluate damage
 Take response measures
 Competent authority can take certain actions:
 Identify operator which caused damage
 Evaluate damage and determine response measures to
be taken
 The competent authority has right to recover from the
operator costs for evaluating damage and any response
measure
 Decisions requiring response measures should be
reasoned and include the opportunity for
administrative or judicial review.
 Parties may assess whether response measures are
already addressed by their domestic law on civil
liability
 Causation – need a causal link
between the damage and the LMO (in
accordance with domestic law)
 Exemptions – can be provided for in
domestic law
 Time limits – can be provided for in
domestic law
 Financial limits and financial security
– can be provided for in domestic law
• Who will be liable?
• Text: Operator is defined as “any person”
• In direct or indirect control of the LMO
• [Including] inter alia, 1) the permit holder,
• 2) Person who placed the LMO on the market,
• 3) Developer (i.e., biotech seed company),
• 4) Producer (farmers),
• 5) Notifier, ???
• 6) Exporter, importer, carrier, or supplier.”
• as appropriate and as determined by domestic
law,
• This gave the International Grain Trade
Coalition qualms during the negotiation
process.
 Provide for rules and procedures that
address damage
 Apply existing domestic law
 Develop new civil liability rules and
procedures
 Do a combination of the two
 Can address “material or personal
damage”
 Shall address: (1) damage (2) standard of
liability (3) channeling of liability and (4)
right to bring claims
LMOs, not products of LMOs (i.e.,
food, feed etc not in scope)
“Traditional” Damages (personal
or property injury) that are do
not relate to conservation and
sustainable use of biological
diversity (CSUB)
 Taking also into account risks to
human health linked to CSUB)
Domestically produced LMOs
Comes into force after 40 countries
have ratified it.
Signature and ratification are not
implementation – not self.
implementing (but also may not
require legal actions).
To date, 54 countries have signed; 14
have ratified.
 Opened for signature 7 March 2011.
 Stayed open for signature until 6 March
2012 for 166 parties to Biosafety Protocol
 54 Nations have signed but still need 40
ratifications… are they well on their way?
 Ratified/Accession – 14 so far…
 Albania, Bulgaria, Czech Republic, European
Union, Ireland, Latvia, Lithuania, Luxembourg,
Mexico, Mongolia, Norway, Spain, Sweden,
Syrian Arab Republic
 Entry into force on the 90th day after deposit
of the 40th instrument of ratification,
acceptance, approval or accession (Art. 18).
Albania, Antigua & Barbuda, Austria,
Belgium, Benin, Bulgaria, Cape Verde,
C.A.R., Chad, Colombia, Cyprus, Czech
Republic, Denmark, European Union,
Finland, France, Germany, Guinea-Bissau,
Hungary, India, Ireland, Italy, Japan, Latvia,
Lithuania, Luxembourg, Madagascar,
Mauritania, Mexico, Mongolia, Montenegro,
Mozambique, Netherlands, Nigeria, Norway,
Panama, Peru, Poland, Portugal, Republic of
Moldova, Romania, Senegal, Slovakia,
Slovenia, Spain, Sweden, Switzerland,
Syrian Arab Republic, Thailand, Togo,
Tunisia, Ukraine, & U.K.
Albania, Antigua & Barbuda, Austria,
Belgium, Benin, Bulgaria, Cape Verde,
C.A.R., Chad, Colombia, Cyprus, Czech
Republic, Denmark, European Union,
Finland, France, Germany, Guinea-Bissau,
Hungary, India, Ireland, Italy, Japan, Latvia,
Lithuania, Luxembourg, Madagascar,
Mauritania, Mexico, Mongolia, Montenegro,
Mozambique, Netherlands, Nigeria, Norway,
Panama, Peru, Poland, Portugal, Republic of
Moldova, Romania, Senegal, Slovakia,
Slovenia, Spain, Sweden, Switzerland,
Syrian Arab Republic, Thailand, Togo,
Tunisia, Ukraine, U.K.
 International Oil Pollution Compensation
(1971 Fund, the 1992 Fund and 2003
Supplementary Fund) – operating but
inadequate?
 IAEA Convention on Nuclear Incidents (But
Nordics reluctant to bring Chernobyl
claims)
 Basel Convention Hazardous Waste.
 Liability Protocol needs 20 ratifications
 Signatories: 13, Parties: 11 (7 from Africa)
 Dead in water?
 Provisional application ok between parties that
have ratified, before entry into force?
 Compact may enable 1st successful liability
protocol.
Redick MSU 7.31.13 NKL supplemental protocol

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Redick MSU 7.31.13 NKL supplemental protocol

  • 1. Thomas P. Redick GEEC, LLC Clayton, MO www.geeclaw.com MSU Biosafety East Lansing, MI July 31, 2013
  • 2.  Negotiation History Requirements of the Supplementary Protocol Relationship to Cartagena & CBD Other liability treaties success- failure Summary and Issues to Consider Going Forward
  • 3. • 1996 Ad Hoc Open-Ended Working Group on Biosafety meeting in Aarhus Denmark • “One-pager” refers to Article XIV of CBD “Examine Issues” • G-77/China insisted on liability being part of protocol; Africa most insistent • Argentina parted ways with G-77/China • Divisive issue when Protocol was being negotiated – continued to be contentious and controversial for 15 years.
  • 4. • 2000 - Cartagena Protocol postpones it -- Article 27 says to hold future negotiations on the topic • “The [COP] shall, at its first meeting, adopt a process [for] • Elaboration of international rules and procedures in the field of liability and redress for damage, • Resulting from transboundary movements of LMOs, • Analysing and taking due account of the ongoing processes in international law on these matters, and shall … • Complete this process within four years.”
  • 5. • Numerous discussions at international meetings related to Protocol • February 2004,COP-MOP 1 appoint Ad Hoc Expert Working Group. • Expert Working Group met 5 times from 2005-2008. • Friends of the Chair working groups further refined issues (“contact groups”) resolving contentious issues. • Last two meetings – Kuala Lumpur and Nagoya – gave NKLSP its name. • Final text approved in Nagoya in 2010 at Cartagena Protocol COP-MOP 5.
  • 6.  Binding supplemental protocol  Administrative procedures to address damages to biological diversity from LMOs, rights belong to governments  Civil liability also binding or just guidelines?  Meet the objectives of Article 27 and CBD Article 14, Rio Principle 13  Compact from Seed Industry played a key role in brokering reasonable compromise – standing ovation
  • 7.  Administrative procedures to address damages to biological diversity from LMOs – Governments will enforce  Private civil liability not made binding.  Meet the objectives of Article 27 without imposing undue burdens on innovation in agricultural biotechnology and grain trade.
  • 8.  “Damage” is significant adverse effect on the conservation and sustainable use of biological diversity - measurable taking into account scientifically established baseline  Baseline requires inventory of species- habitats that could take years to adequately compile.  International liability precedent of Canada- US “Trail Smelter” case and NKLSP defined “significant” as:  Long term or permanent change not redressed through natural recovery  Qualitative and quantitative changes adversely affecting components of biological diversity  Reducing ecosystem/biodiversity goods/services
  • 9.  First multilateral environmental agreement to define damage to biodiversity  Example – Chinese native rice displaced, lost to future generations of valuable genes?  Confirmation of value of genetic resources and need to protect them from all threats (even if this is just one of many threats)  Industry recognized long-range value of protecting the genetic resources that modern plant breeders rely upon.  Biotech seed industry’s innovative power imparts additional value to the genetic resources in wide range of species (even microbes).
  • 10.  1992 Convention on Biological Diversity objectives: 1) conservation, 2) sustainable use, and 3) equitable distribution of benefit and “appropriate access to genetic resources”  CDB Art. 14 suggested that the parties “examine the issues” of liability, except where internal issue.  Rio Principle 13 has similar suggestion.  Cartagena Protocol on Biosafety must serve objectives of CBD.  Cartagena Protocol on Biosafety, ten years after its text, created a text on liability.
  • 11. “Reasonable actions to:  Prevent, minimize, contain, mitigate, or otherwise avoid damage, as appropriate’  Restore biological diversity through actions to be undertaken in the following order of preference:  Restoration of biological diversity to the condition that existed before the damage occurred…  “Restoration by replacing the biological diversity with other components of biological diversity for the same or for another type of use either at the same or, as appropriate, at an alternative location.”
  • 12.  “Where relevant information … indicates there is sufficient likelihood that damage will result if timely response measures are not take, …”  Examples – chemical storage tank in bad condition and likely to leak or started leaking and is likely to migrate to water body; tank is leaking, enters aquifer but damage is not significant yet.  Oil Spill in Gulf of Mexico -- oil leaking before damage to birds, beaches, etc… but only a matter of time (need to respond)
  • 13.  Parties can require operators to take certain actions in the event of damage  Inform the competent authority  Evaluate damage  Take response measures  Competent authority can take certain actions:  Identify operator which caused damage  Evaluate damage and determine response measures to be taken  The competent authority has right to recover from the operator costs for evaluating damage and any response measure  Decisions requiring response measures should be reasoned and include the opportunity for administrative or judicial review.  Parties may assess whether response measures are already addressed by their domestic law on civil liability
  • 14.  Causation – need a causal link between the damage and the LMO (in accordance with domestic law)  Exemptions – can be provided for in domestic law  Time limits – can be provided for in domestic law  Financial limits and financial security – can be provided for in domestic law
  • 15. • Who will be liable? • Text: Operator is defined as “any person” • In direct or indirect control of the LMO • [Including] inter alia, 1) the permit holder, • 2) Person who placed the LMO on the market, • 3) Developer (i.e., biotech seed company), • 4) Producer (farmers), • 5) Notifier, ??? • 6) Exporter, importer, carrier, or supplier.” • as appropriate and as determined by domestic law, • This gave the International Grain Trade Coalition qualms during the negotiation process.
  • 16.  Provide for rules and procedures that address damage  Apply existing domestic law  Develop new civil liability rules and procedures  Do a combination of the two  Can address “material or personal damage”  Shall address: (1) damage (2) standard of liability (3) channeling of liability and (4) right to bring claims
  • 17. LMOs, not products of LMOs (i.e., food, feed etc not in scope) “Traditional” Damages (personal or property injury) that are do not relate to conservation and sustainable use of biological diversity (CSUB)  Taking also into account risks to human health linked to CSUB) Domestically produced LMOs
  • 18. Comes into force after 40 countries have ratified it. Signature and ratification are not implementation – not self. implementing (but also may not require legal actions). To date, 54 countries have signed; 14 have ratified.
  • 19.  Opened for signature 7 March 2011.  Stayed open for signature until 6 March 2012 for 166 parties to Biosafety Protocol  54 Nations have signed but still need 40 ratifications… are they well on their way?  Ratified/Accession – 14 so far…  Albania, Bulgaria, Czech Republic, European Union, Ireland, Latvia, Lithuania, Luxembourg, Mexico, Mongolia, Norway, Spain, Sweden, Syrian Arab Republic  Entry into force on the 90th day after deposit of the 40th instrument of ratification, acceptance, approval or accession (Art. 18).
  • 20. Albania, Antigua & Barbuda, Austria, Belgium, Benin, Bulgaria, Cape Verde, C.A.R., Chad, Colombia, Cyprus, Czech Republic, Denmark, European Union, Finland, France, Germany, Guinea-Bissau, Hungary, India, Ireland, Italy, Japan, Latvia, Lithuania, Luxembourg, Madagascar, Mauritania, Mexico, Mongolia, Montenegro, Mozambique, Netherlands, Nigeria, Norway, Panama, Peru, Poland, Portugal, Republic of Moldova, Romania, Senegal, Slovakia, Slovenia, Spain, Sweden, Switzerland, Syrian Arab Republic, Thailand, Togo, Tunisia, Ukraine, & U.K.
  • 21. Albania, Antigua & Barbuda, Austria, Belgium, Benin, Bulgaria, Cape Verde, C.A.R., Chad, Colombia, Cyprus, Czech Republic, Denmark, European Union, Finland, France, Germany, Guinea-Bissau, Hungary, India, Ireland, Italy, Japan, Latvia, Lithuania, Luxembourg, Madagascar, Mauritania, Mexico, Mongolia, Montenegro, Mozambique, Netherlands, Nigeria, Norway, Panama, Peru, Poland, Portugal, Republic of Moldova, Romania, Senegal, Slovakia, Slovenia, Spain, Sweden, Switzerland, Syrian Arab Republic, Thailand, Togo, Tunisia, Ukraine, U.K.
  • 22.  International Oil Pollution Compensation (1971 Fund, the 1992 Fund and 2003 Supplementary Fund) – operating but inadequate?  IAEA Convention on Nuclear Incidents (But Nordics reluctant to bring Chernobyl claims)  Basel Convention Hazardous Waste.  Liability Protocol needs 20 ratifications  Signatories: 13, Parties: 11 (7 from Africa)  Dead in water?  Provisional application ok between parties that have ratified, before entry into force?  Compact may enable 1st successful liability protocol.

Editor's Notes

  1.  MAFF originally excluded oil and other highly processed food made withGM ingredients from the List because the absence or presence of GM content could notbe verified through testing, with foreign DNA being destroyed during processing.Nonetheless, on 3 September 2001, MAFF revised the labeling proposal to requirehigh oleic acid soybean oil made from high oleic acid GM soybeans be labeled as "GMhigh oleic soybean oil."Diana Wong, Genetically Modified Food Labeling (19 March 2003)http://www.legco.gov.hk/yr02-03/english/sec/library/0203rp05e.pdf
  2.  MAFF originally excluded oil and other highly processed food made withGM ingredients from the List because the absence or presence of GM content could notbe verified through testing, with foreign DNA being destroyed during processing.Nonetheless, on 3 September 2001, MAFF revised the labeling proposal to requirehigh oleic acid soybean oil made from high oleic acid GM soybeans be labeled as "GMhigh oleic soybean oil."Diana Wong, Genetically Modified Food Labeling (19 March 2003)http://www.legco.gov.hk/yr02-03/english/sec/library/0203rp05e.pdf
  3.  http://bch.cbd.int/nkl_suppl_protocol/introductorynote.pdf
  4. Principle 13 of the 1992 Rio Declaration on Environment and Development which appeals to States to “cooperate in an expeditious and more determined manner to develop further international law regarding liability and compensation for adverse effects of environmental damage caused by activities within their jurisdiction or control”.
  5. Missouri, Arkansas, Texas, Louisiana and Mississippi (not CA)The next test, or bellwether trial, involving farmers from Arkansas and Mississippi, is scheduled to start on Jan. 11 in St. Louis
  6. The Supplementary Protocol defines “damage” as an adverse effect on the conservation and sustainable use of biological diversity that is measurable and significant. Paragraph 2, Article 2 of the Supplementary Protocol.e first multilateral environmental agreement to define „damage to biodiversity
  7. The Supplementary Protocol defines “damage” as an adverse effect on the conservation and sustainable use of biological diversity that is measurable and significant. Paragraph 2, Article 2 of the Supplementary Protocol.e first multilateral environmental agreement to define „damage to biodiversity
  8. Tell how RTRS and RSB but others responded to US soybean and corn grower association comments by going technology neutral. expert group decided non-GM must establish a buffer, changing current text requiring “GM” growers to “prevent migration” to non-GM crops
  9. October 11 2005 @ 09:37 AM PDT  Viewed:  954 times   Court Orders Public Oversight of 'Biopharm' Experiment in Hawaii;Environmental Review Required for Genetically Engineered Algae ProjectKAILUA-KONA, Hawaii, Oct. 11 /U.S. Newswire/ -- Yesterday, citizen groups 'Ohana Pale Ke Ao, Kohanaiki 'Ohana, GMO Free Hawai'i, and Sierra Club, Hawai'i Chapter, represented by Earthjustice, obtained a court judgment in their favor in a lawsuit they brought in the Circuit Court of the State of Hawai'i, Third Circuit, challenging the state Board of Agriculture's approval of a project to mass-produce potentially dangerous genetically engineered algae on the Kona coast of the Island of Hawai'i. Circuit Court Judge Elizabeth A. Strance agreed with the citizen groups that the Board was required to comply with the environmental review process under the Hawai'i Environmental Policy Act (HEPA) before approving the project. The Court granted the groups' request for a judgment declaring that, at minimum, an environmental assessment (EA) was required for the project, and that the Board's approval without such review was invalid.
  10.  Japan does not require labeling for GM oil in food, but would mandate GM label on biotech oils for output traits used in food production.MAFF originally excluded oil and other highly processed food made withGM ingredients from the List because the absence or presence of GM content could notbe verified through testing, with foreign DNA being destroyed during processing.Nonetheless, on 3 September 2001, MAFF revised the labeling proposal to requirehigh oleic acid soybean oil made from high oleic acid GM soybeans be labeled as "GMhigh oleic soybean oil."Diana Wong, Genetically Modified Food Labeling (19 March 2003)http://www.legco.gov.hk/yr02-03/english/sec/library/0203rp05e.pdf
  11. Sustainability Consortium –input missing from producers (troubling language on coexistence of biotech-organic will be resolved in producer meetings)Stewardship Index for Specialty Crops- $761,820 for grant period from October 2011- September 2013
  12. Tell how RTRS and RSB but others responded to US soybean and corn grower association comments by going technology neutral. expert group decided non-GM must establish a buffer, changing current text requiring “GM” growers to “prevent migration” to non-GM crops
  13. Tell how RTRS and RSB but others responded to US soybean and corn grower association comments by going technology neutral. expert group decided non-GM must establish a buffer, changing current text requiring “GM” growers to “prevent migration” to non-GM crops
  14. Tell how RTRS and RSB but others responded to US soybean and corn grower association comments by going technology neutral. expert group decided non-GM must establish a buffer, changing current text requiring “GM” growers to “prevent migration” to non-GM crops
  15. Tell how RTRS and RSB but others responded to US soybean and corn grower association comments by going technology neutral. expert group decided non-GM must establish a buffer, changing current text requiring “GM” growers to “prevent migration” to non-GM crops
  16. Tell how RTRS and RSB but others responded to US soybean and corn grower association comments by going technology neutral. expert group decided non-GM must establish a buffer, changing current text requiring “GM” growers to “prevent migration” to non-GM crops