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Please forgive the vagueness of this information but I'm only now
beginning to wrap my head around Nagoya and what it will mean for
importing into and exporting from the U.S. I wanted to share what I
learned from my conversation with the State Dept. staffer who is the
U.S. point of contact (and herself holds a Ph.D in evolutionary
biology, so she speaks the language, so to speak).<br>
<br>
Realize that the U.S. is not a party to the Convention on Biological
Diversity and therefore can't ratify the Nagoya Protocol
<meta charset="utf-8">
on Access to Genetic Resources and the Fair and Equitable Sharing of
Benefits Arising from their Utilization (ABS). The ABS
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is a supplementary agreement to the Convention on Biological
Diversity. It provides a transparent legal framework for the
effective implementation of one of the three objectives of the CBD:
the fair and equitable sharing of benefits arising out of the
utilization of genetic resources.<br>
<br>
However, the U.S. (through the State Dept.) attends the meetings as
an observer and does the best it can in that constrained role to
represent the interests of the U.S. and its citizens. <br>
<br>
Nagoya has been in force since 2014 but as with all international
agreements, it takes a while for the parties to get their internal
acts together, i.e., developing in-country implementing legislation,
regulations, procedures (witness CITES - about 1/3 of the countries
do not yet have internal legislation - and that's been 30 plus
years). <br>
<br>
To keep up with Nagoya's development, there is a webpage:
<a class="moz-txt-link-freetext" href="https://urldefense.proofpoint.com/v2/url?u=https-3A__absch.cbd.int_&d=AwMDaQ&c=-dg2m7zWuuDZ0MUcV7Sdqw&r=CLFZJ3fvGSmDp7xK1dNZfh6uGV_h-8NVlo3fXNoRNzI&m=3oM8knvzjelrZwQJfOG0G0ggb15GLtssw7Npv88neMg&s=m9kWbQWawQ-M2p20L_MLGjGHe6zG5inru40a7MgzKbo&e=">https://absch.cbd.int/</a><br>
<br>
For each country, you can determine if there is a <br>
- focal point (contact person)<br>
- competent national authority (agency designated to implement) <br>
- internal legislation, regulation, or procedure<br>
<br>
In theory, this will generally affect scientific exports in that you
will have to show that you have met the requirements of the
exporting country in terms of <br>
<br>
- having a valid access agreement, if one is required<br>
and <br>
- prior informed consent (of the owner of the resource) - in other
words, before getting permission to collect, you told that owner
that the resource might be<br>
used for commercial benefit and that you would meet the requirements
of the owner, if any, for sharing of those benefits<br>
<br>
Where this gets messy in a hurry is pre-Nagoya "stuff" because each
country is going to have its own rules. One would hope that the
countries realize that anything but prospective application is going
to be a huge problem. You can't retroactively get prior informed
consent once something was already collected. But even
prospectively, each country may have a different starting date. <br>
<br>
Right now, in the U.S., the only federal landowner with a benefits
sharing agreement is the National Park Service. Therefore. if you
collect on NPS lands, be sure to keep both the permits and the
benefits sharing agreements. In perpetuity. Because you never know
when someone will export that material. If it is going to a Nagoya
country, it is going to be a legal requirement. <br>
<br>
In terms of private landowners in countries, such as the U.S., if
the U.S. law does not require prior informed consent, then in
theory, you will not have to prove prior informed consent in order
to export to a Nagoya country. <br>
<br>
Really, in a way this is similar to the way the U.S. Lacey Act works
in requiring that in order to import, you have to have complied with
all the laws of the exporting country. That could be collecting
and/or export permits, but in countries like India and Brazil, it is
benefits sharing agreements, too. <br>
<br>
What is even more worrisome is that the Nagoya Protocol doesn't
define utilization in a precise manner: <br>
<br>
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<i>Utilization of genetic resources” means to conduct research and
development on the genetic and/or biochemical composition of
genetic resources, including through the application of
biotechnology as defined in Article 2 of the Convention</i><i><br>
<br>
</i>Which is: <br>
<br>
<meta charset="utf-8">
<i>"Genetic resources" means genetic material of actual or potential
value.<br>
<br>
</i>(Pretty much anything with nucleic acids)<br>
<br>
So to be on the safe side, you pretty much have to assume that you
are going to be dealing with Nagoya. If exporting from the U.S.,
that means having to prove compliance with U.S. law, which at this
point, except for the NPS, does not require benefits sharing
agreements. To the best of my knowledge, there are no prior consent
requirements in any state, but I haven't researched it. It may
(probably will) require proof that the material was collected
lawfully and if that requirement is retrospective, that could be a
problem. <br>
<br>
However, it is definitely going to be prospective, so from now on,
you are going to need to keep (paper or scan? who knows?) all
documents associated with specimens and samples. Forever.<br>
<br>
If a country's requirement is retroactive and the material was
collected before permits were required, it is not clear how you will
be able to prove that. It is not yet known if some U.S. government
agency will issue documentation to verify that no permit was needed.
If a permit was needed but you have no copy, and the issuing agency
has no copy...who knows.<br>
<br>
FWIW, here's the EU regulation, which may very well be a model for
other countries:
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<br>
Ellen<br>
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<p class="MsoNormal">Ellen Paul</p>
<p class="MsoNormal">Executive Director</p>
<p class="MsoNormal"><a href="https://urldefense.proofpoint.com/v2/url?u=http-3A__www.nmnh.si.edu_BIRDNET&d=AwMDaQ&c=-dg2m7zWuuDZ0MUcV7Sdqw&r=CLFZJ3fvGSmDp7xK1dNZfh6uGV_h-8NVlo3fXNoRNzI&m=3oM8knvzjelrZwQJfOG0G0ggb15GLtssw7Npv88neMg&s=eUQMyB3ky8FmOQ5MOp3HSBdsmg3mKC1ATTpFj5JsNJ0&e=">Ornithological
Council</a> <br>
Providing Scientific Information about Birds</p>
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