Difference between revisions of "User:A.Plank/Permit and Loan Terms (Handbook)"

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== ReadMe ==
 +
 +
This page informs about the contents of this file
 +
 +
The basis for the work in this folder are the existing GGBN Permit Types (in the table “Permit Types (GGBN)”) which we will improve.
 +
 +
We are creating a two tiered system for grouping permits (based on permits we personally know), at the lower level it comprises different “document types” , which are further grouped into “document categories”.
 +
 +
This helps getting an overview of documents relevant for holding biological specimens in collections, it may also help with filing these documents orderly in a filing cabinet or electronically.
 +
 +
Because documents from different countries, belonging to the same document type (sometimes even having identical document titles), may have different content with respect to permissions, duties, restrictions and prohibitions, we additionally created a “typology of contents” by compiling and listing relevant contents of permit and loan documents we know.
 +
 +
The “typology of contents” intends to list relevant individual actions that commonly may be permitted, required, restricted or prohibited, as well as necessary quality requirements.
 +
 +
The “typology of contents” also indicates the corresponding legal background. Elements of this “typology of contents” may help to flag possible uses of different collection specimens.
 +
 +
The following tables are <strong>active working documents</strong>, or finalised results of our work:
 +
* [[#Document Category|Document Category]] - final
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* [[#Document Types w o IPR|Document Types w/o IPR]] (draft)
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* Typology of Contents (draft)
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 +
The following tables show elements of our work which <strong>we do not pursue any more:</strong>
 +
* MTA examples
 +
* US specific permits: a very incomplete list of US permits that may apply to different actions
 +
* EU specific permits: a very imcomplete list of supranational EU-regulated permits (does not contain permits applicable only in single member states of EU)
 +
* (AU specific permits): without participants from Australia this topic can not be pursued within the limits of T3.3
 +
* Document Category (for discussion): old version
 +
* Intellectual Property Document Types (draft): we decided that intellectual property is such a wide field, we also have no legal counsel in our group, additionally considering the limited time of task 3.3, therfore we will not pursue this topic any more
 +
 +
https://wiki.ggbn.org/ggbn/GGBN_Data_Standard_v1#GGBN_Permit_Vocabulary
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== Document Category <span id="Document_Category"></span> - final ==
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{| class="vertical-align-top booktabledotted"
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|-
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! Document Categories
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! Definition for document category
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! associated document types
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! working remarks on definitions
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|- style="background-color: #f4cccc;"
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| Access and Benefit-Sharing Document
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| documents permiting the access to genetic resources for their utilisation and/or covering the terms of benefit-sharing
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| Mutually Agreed Terms (MAT)<br />
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<br />Internationally Recognized Certificate of Compliance (IRCC)<br />
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<br />Prior Informed Consent (PIC)<br />
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<br />other ABS document (e.g. biomedical, BBNJ)
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| FL: In the final document, I think a glossary would be useful to explain terms like “genetic resources”<br />
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SE: a glossary is a good idea, please indicate which terms shall be explained, e.g. highlighting them bold and wisth asterisk
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|-  style="background-color: #f9cb9c;"
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| High level arrangements
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| documents that require signature(s) by (a) member(s) of the highest management level of an institution
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| Contract (legally binding)<br />
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<br />Memorandum of Cooperation (MoC)<br />
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<br />Memorandum of Understanding (MoU)
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| FL: or even higher level? (e.g. arrangements that have been made between governments concerning the possessing colonial collections).
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|- style="background-color: #fff2cc;"
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| permits for collecting/taking/posessing/using
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| documents by authorities or private entities allowing certain actions that are under their jurisdiction - except ABS-permits, research permits and permits related to the transport of specimens (see the relevant other document categories)
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| <br />
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Collecting permit<br />
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<br />Taking: “incidental take” permit<br />
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<br />Taking: Migratory Bird Treaty Act (MBTA) Special Purpose, Salvage Permit<br />
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<br />Taking: Salvage Permit (e.g., Non-US, US federal, state, local)<br />
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<br /><br />
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<br />Possessing: Receiving permit<br />
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<br />Use: ethical oversight document<br />
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<br />Use: Permit to reintroduce/translocate organism into the wild<br />
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<br />Use: bioprospecting permit<br />
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<br />Use: Landowner letter<br />
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<br />Use: Public property use permit<br />
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<br />Use: Data use agreement
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|
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|- style="background-color: #d9ead3;"
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| Research Permission
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| document by an authority allowing basic and/or applied research within its territory
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| Research Permit
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|
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|- style="background-color: #d0e0e3;"
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| material transfer agreements, stewardships &amp; related inforrmation
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| <span style="color:#ff6d01;">documents demonstrating the will of two parties regarding</span> <s>governs</s> the transfer of tangible material between <span style="color:#ff6d01;">them</span> <s>two parties</s> (e.g., an agreement between two institutions that outlines the terms and conditions for transferring specimens or samples; <span style="color:#ff6d01;">for stewardships the conceding party is a public authority</span>) or <span style="color:#ff6d01;">which include such information for transfers in the past. This document category does not cover shipping documents or contracts with a carrier (see transport documents).</span>
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| Public law MTA (e.g. acquiring customs' seizures, stewrdship agreements, or SMTA for ITPGRFA-purposes)<br />
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<br />Institutional MTA (e.g. loans)<br />
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<br />Deeds of transfer (e.g. private gifts)<br />
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<br />provenance evidence
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|
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|- style="background-color: #c9daf8;"
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| Transport Documents
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| permits, certificates and other documents necessary for the act of sending specimens from one place to another
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| (Phyto-)Sanitary/Veterinary Certificate<br />
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<br />Permit to move across boundaries<br />
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<br />CITES export permits<br />
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<br />CITES import permits<br />
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<br />CITES certificates of scientific exchange<br />
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<br />Original Export Permit<br />
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<br />Export Permit<br />
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<br />Original Import Permit<br />
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<br />Import Permit<br />
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<br /><span style="color:#ff6d01;">other (e.g. carrier contracts)</span>
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|
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|- style="background-color: #d9d2e9;"
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| Exemption Permission (alternative option: Exemption Evidence?)
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| certificates and other documents demonstrating that other permits are not necessary
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| exemptional authorisation
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| FL: this sounds very broad, and I wonder if exemptions are not already included in any of the above document types.
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|}
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== Document Types w/o IPR (draft) <span id="Document_Types_w_o_IPR"></span> ==
 
== Document Types w/o IPR (draft) <span id="Document_Types_w_o_IPR"></span> ==
  

Revision as of 14:18, 26 September 2022

ReadMe

This page informs about the contents of this file

The basis for the work in this folder are the existing GGBN Permit Types (in the table “Permit Types (GGBN)”) which we will improve.

We are creating a two tiered system for grouping permits (based on permits we personally know), at the lower level it comprises different “document types” , which are further grouped into “document categories”.

This helps getting an overview of documents relevant for holding biological specimens in collections, it may also help with filing these documents orderly in a filing cabinet or electronically.

Because documents from different countries, belonging to the same document type (sometimes even having identical document titles), may have different content with respect to permissions, duties, restrictions and prohibitions, we additionally created a “typology of contents” by compiling and listing relevant contents of permit and loan documents we know.

The “typology of contents” intends to list relevant individual actions that commonly may be permitted, required, restricted or prohibited, as well as necessary quality requirements.

The “typology of contents” also indicates the corresponding legal background. Elements of this “typology of contents” may help to flag possible uses of different collection specimens.

The following tables are active working documents, or finalised results of our work:

The following tables show elements of our work which we do not pursue any more:

  • MTA examples
  • US specific permits: a very incomplete list of US permits that may apply to different actions
  • EU specific permits: a very imcomplete list of supranational EU-regulated permits (does not contain permits applicable only in single member states of EU)
  • (AU specific permits): without participants from Australia this topic can not be pursued within the limits of T3.3
  • Document Category (for discussion): old version
  • Intellectual Property Document Types (draft): we decided that intellectual property is such a wide field, we also have no legal counsel in our group, additionally considering the limited time of task 3.3, therfore we will not pursue this topic any more

https://wiki.ggbn.org/ggbn/GGBN_Data_Standard_v1#GGBN_Permit_Vocabulary

Document Category - final

Document Categories Definition for document category associated document types working remarks on definitions
Access and Benefit-Sharing Document documents permiting the access to genetic resources for their utilisation and/or covering the terms of benefit-sharing Mutually Agreed Terms (MAT)


Internationally Recognized Certificate of Compliance (IRCC)

Prior Informed Consent (PIC)

other ABS document (e.g. biomedical, BBNJ)

FL: In the final document, I think a glossary would be useful to explain terms like “genetic resources”

SE: a glossary is a good idea, please indicate which terms shall be explained, e.g. highlighting them bold and wisth asterisk

High level arrangements documents that require signature(s) by (a) member(s) of the highest management level of an institution Contract (legally binding)


Memorandum of Cooperation (MoC)

Memorandum of Understanding (MoU)

FL: or even higher level? (e.g. arrangements that have been made between governments concerning the possessing colonial collections).
permits for collecting/taking/posessing/using documents by authorities or private entities allowing certain actions that are under their jurisdiction - except ABS-permits, research permits and permits related to the transport of specimens (see the relevant other document categories)

Collecting permit

Taking: “incidental take” permit

Taking: Migratory Bird Treaty Act (MBTA) Special Purpose, Salvage Permit

Taking: Salvage Permit (e.g., Non-US, US federal, state, local)



Possessing: Receiving permit

Use: ethical oversight document

Use: Permit to reintroduce/translocate organism into the wild

Use: bioprospecting permit

Use: Landowner letter

Use: Public property use permit

Use: Data use agreement

Research Permission document by an authority allowing basic and/or applied research within its territory Research Permit
material transfer agreements, stewardships & related inforrmation documents demonstrating the will of two parties regarding governs the transfer of tangible material between them two parties (e.g., an agreement between two institutions that outlines the terms and conditions for transferring specimens or samples; for stewardships the conceding party is a public authority) or which include such information for transfers in the past. This document category does not cover shipping documents or contracts with a carrier (see transport documents). Public law MTA (e.g. acquiring customs' seizures, stewrdship agreements, or SMTA for ITPGRFA-purposes)


Institutional MTA (e.g. loans)

Deeds of transfer (e.g. private gifts)

provenance evidence

Transport Documents permits, certificates and other documents necessary for the act of sending specimens from one place to another (Phyto-)Sanitary/Veterinary Certificate


Permit to move across boundaries

CITES export permits

CITES import permits

CITES certificates of scientific exchange

Original Export Permit

Export Permit

Original Import Permit

Import Permit

other (e.g. carrier contracts)

Exemption Permission (alternative option: Exemption Evidence?) certificates and other documents demonstrating that other permits are not necessary exemptional authorisation FL: this sounds very broad, and I wonder if exemptions are not already included in any of the above document types.

Document Types w/o IPR (draft)

Document Category (Under Discussion) Status term Specific Document Type Definition (initial text by Breda Zimkus as starting point) Additional information Examples Applies to preserved material Applies to living material Working remarks Remarks
Access and Benefit-Sharing Document Term & definition approved Mutually Agreed Terms (MAT) A contract associated with benefit sharing in the context of Convention on Biological Diversity (CBD) including Nagoya Protocol (NP). It may be named Mutually Agreed Terms (MAT) or have another title, and contains the result of negotiations between the provider of genetic resources and users on benefits to be shared arising out of the utilization of genetic resources. According to the Nagoya Protocol MAT is not on access, access is subject to PIC only. The term MAT rather seems to describe the process of negotiations between equal partners than a formally required title of the contract. In practice PIC and MAT may be covered in the same document, and because paragraphs representing PIC are the requirements for text representing MAT it is suggested to file such combined documents under PIC. Simple collecting permit from countries without national requirements for Access and Benefit-Sharing to/from their own genetic resources should be filed under “permits for collecting/taking/posessing/using” Yes Yes Suggestion: contract according to the Nagoya Protocol’s access and benefit-sharing provisions; this contract may have a different name than Mutually Agreed Terms (MAT) and may be one part of e.g. a combined document covering PIC as well; it is a contract between a) the country providing genetic resources and users, on the benefits from the utilization of genetic resources as well as subsequent applications and commercialisation to be shared between both parties; and/or b) indigenous and local communities respectively and users, on the benefits from the utilization of traditional knowledge associated with genetic resources to be shared between them.

FL: or shorter “A contractual agreement used in Article 15 CBD and the Nagoya Protocol, establishing that specific benefit-sharing conditions must be mutually agreed between providers and users of genetic resources.”

MAT is NOT on access, access is subject to PIC only; in the Nagoya Protocol MAT rather seems to describe the process of negotiations between equal partners, not formalizing the title of a contract

CL: this is correct as a formal distinction. However, in practice, particularly for non-commercial uses, PIC and MAT may be covered in the same document. For the purposes of collection management, the label 'MAT' might be applicable to a simple collecting permit because it contains contractual elements with the provider country.
SE: If PIC and “MAT” are covered in the same document, like in the example of a permit containing elements on benefit sharing, I suggest to put them into the document type “PIC”, because in this situation the elements on benefit-sharing probably do not originate from mutual negotiations between equal partners, but from an authority setting terms for a user to fulfil, without individual negotiations

Access and Benefit-Sharing Document under review specialised standard ABS terms / SMTA An internationally agreed “Standard Material Transfer Agreement-SMTA” used for the International Treaty on Plant Genetic Resources for Food and Agriculture (ITPGRFA) and the Pandemic Influenza Preparedness framework (PIP)
Access and Benefit-Sharing Document Term & definition approved Internationally Recognized Certificate of Compliance (IRCC) A record generated on the ABS Clearing House when the Competent National Authority of a Providing Country publishes a permit or equivalent (e.g. PIC, MAT) there. This record is given a unique identifier by the Clearing House and provides legal surety of the genetic resources covered.
Access and Benefit-Sharing Document Term approved, check definition Prior Informed Consent (PIC) with reference to the remark in cell I5 I suggest the following wording: 1) A written permission given by a government authority of a provider country to a user prior to accessing genetic resources for their utilization most often based on the national legal implementation of Convention on Biological Diversity (CBD) including Nagoya Protocol (NP), and in line with an appropriate national legal and institutional framework. The agreement will specify what the permitted uses are. 2) the prior and informed consent by, or approval and involvement of permission given by an IPLC indigenous or local communities on access to their for use of associated traditional knowledge associated withor genetic resources for utilisation. The agreement will specify what the permitted uses are. 3) A PIC can also be the leading part of a combined document covering the contents of MAT as well. In this situation the paragraphs representing PIC are the requirements for text representing MAT and therefore it is suggested to file such combined documents under PIC. Suggestion: A) a permission by a competent national authority of a provider country to a user of genetic resources (GR), granting access to GR for utilization or giving evidence that applicable access requirements for GR have been met (e.g. approval and involvement of indigenous and local communities) - the permission will specify what can be done with the GR and may be one part of e.g. a combined document covering MAT as well. B) for traditional knowledge associated with genetic resources, “PIC” is a written statement that indigenous and local communities have been informed on the user’s intentions for their traditional knowledge, that they gave their consent or approval for it, and have been involved in accessing the knowledge (where applicable, that their community protocols and customary laws have been followed). If domestic law, customary law and community protocols do not schedule a formal written statement, the user is encouraged to log the process of getting Prior Informed Consent.
Access and Benefit-Sharing Document Term approved, check definition other ABS document (e.g. biomedical, BBNJ) Formal agreement with an individual, legal person or government containing terms and conditions related to access to, use of, and benefits arising from, biological resources, outside the mandate of the CBD. This refers to documents outside the CBD. These are documents (i) issued by countries or others under other Access & Benefit-Sharing (ABS) instruments, such as the plant treaty ITPGRFA, or PIP framework; (ii) under international treaties for areas outside national jurisdication, e.g. under the Antarctic treaty or the upcoming BBNJ instrument (when agreed); (iii) covering biomedical samples, where ABS applies to the individual donor. CL: This refers to documents outside the CBD. These are documents (i) issued by countries or others under other instruments, such as the plant treaty or PIP framework; (ii) under international treeaty for areas outside national jurisdication, e.g. under the Antarctic treaty or the BBNJ instrument when agreed; (iii) covering biomedical samples, where ABS applies to the individual donor.

FL: also mention areas beyond national jurisdiction, such as international waters and the deep sea (https://doi.org/10.1080/09644016.2021.1911442)?

countries that are not parties to the NP may also have ABS legislation and related documents. This raises two questions: First, do we want to use the document types “MAT” and “PIC” exclusively for documents issued in the legal framework of the Nagoya Protocol, or do we want to use it for a mixture of non-NP-documents and NP-documents if they have the same intention (permit for utilization, and benefit-sharing-agreement respectively), Second, do we have examples of ABS-documents from countries outside the legal NP-framework?

CL: There should be no distinction between ABS documents issued by countries for biodiversity under their sovereign rights and in the context of the CBD according to whether they were parties to the NP or not. These all have the same properties and should be treated as the same. This section should be reserved for documents (i) issued by countries or others under other instruments, such as the plant treaty or PIP framework; (ii) under international treeaty for areas outside national jurisdication, e.g. under the Antarctic treaty or the BBNJ instrument when agreed; (iii) covering biomedical samples, where ABS applies to the individual donor.

High Level Arrangements Term & definition approved Contract (legally binding) formal and legally binding agreement signed between parties (for contracts on “benefit-sharing” use the ABS-document “Mutually Agreed Terms”; for contracts on transferring (collection) objects use a document in the category “Material Transfer Agreement, etc.”) for MAT use the dedicated term
High Level Arrangements Term & definition approved Memorandum of Cooperation (MoC, not legally binding) a document that outlines - without binding effect - the terms and details of cooperation between parties. MOC und MOU may be understood differently by different organisations. The terms MoC and MoU seem to be understood differently by different orgalisations and definition providers. The MoC my be understood as a document in which two or more parties agreed upon to work together for a common objective, whereas the Memorandum of Understanding (MoU) may be understood as a written document which describes the terms of an agreement. what is the difference between MOU and “MOC” - is there a widely accepted explanation why a “MOC” is not the same as MOU? The terms seem to be understood differently by different orgalisations and definition providers. I suggest that in both cases (and we should keep the two terms since organisations may use either), we should indicate that they are not legally binding documents. CL
High Level Arrangements Term & definition approved Memorandum of Understanding (MoU, not legally binding) a document that outlines - without binding effect - the terms and details of an understanding between parties; A memorandum of understanding is a type of agreement between two or more parties. It expresses a convergence of will between the parties, indicating an intended common line of action The terms MoU and MoC seem to be understood differently by different orgalisations and definition providers. The MoU may be understood as a written document which describes the terms of an agreement, whereas the Memorandum of Cooperation (MoC) may be understood as a document in which two or more parties agreed upon to work together for a common objective. Wikipedia: “A memorandum of understanding (MoU) is a type of agreement between two (bilateral) or more (multilateral) parties. It expresses a convergence of will between the parties, indicating an intended common line of action. It is often used either in cases where parties do not imply a legal commitment or in situations where the parties cannot create a legally enforceable agreement. It is a more formal alternative to a gentlemen's agreement.” (https://en.wikipedia.org/wiki/Memorandum_of_understanding) MoC versus MoU: The agreement (MoC) is a document in which two or more parties agreed upon to work together for a common objective, whereas the Memorandum of Understanding (MoU) is a written document which describes the terms of an agreement.
will be removed Material Transfer Agreement (MTA) governs the transfer of tangible materials between two parties (e.g., an agreement between two institutions that outlines the terms and conditions for transferring specimens or samples) Standard Material Transfer Agreement (FAO), deed of transfer/gift (private donations); see separate sheet Suggestion: terms and conditions for transfering tangible materials (e.g. specimens or samples) between two legal or natural persons
permits for collecting/taking/possessing/using Term approved, check definition Collecting Permit authorizes the collection of specimens, DNA, tissue or environmental samples in the wild according to legal restrictions (e.g. protected species/areas, special techniques) AND where this is not covered by a legal requirement to obtain in an ABS-permit/PIC; note: this document category includes Hunt/Fish/Trap licenses, salvage may be included unless special legislation applies calls for a separate type of permit (e.g. for migratory birds) Brazilian SISBIO system which issues collecting permits, especially in protected áreas (https://www.icmbio.gov.br/cpb/index.php/sisbio  http://www.icmbio.gov.br/sisbio) Suggestion: authorizes the collection of specimens, DNA, tissue or environmental samples in the wild according to legal restrictions (e.g. protected species/areas, special techniques) AND where this is not covered in an ABS-permit/PIC; note: this document category includes Hunt/Fish/Trap licenses, salvage may be included it might be better to change “ABS-legislation” to “ABS-permit/PIC” because ABS-legislation may cover only one of two necessary permits (the one for access to GR), the other may be covered by conservation legislation, e.g. on killing or harassing protected species
permits for collecting/taking/possessing/using Term approved, check definition Taking: “incidental take” permit permit required when a protected species is harassed, harmed, pursued, hunted, shot, wounded, killed, trapped, captured, or collected as a consequencce of an approved or lawful activity Endangered Species Act (ESA) incidental take permit; a migratory bird, their nests and/or eggs can be inadvertently harmed or disturbed as a result of an approved activiy (e.g., clearing trees and other vegetation, draining or flooding land, or using fishing gear) Only US? Restricted to animals, or does it also include plants, fungi and other eurkaryotes?
permits for collecting/taking/possessing/using Term & definition approved Taking: Migratory Bird Treaty Act (MBTA) Special Purpose, Salvage Permit permit required to salvage migratory birds regulated under the US Migratory Bird Treaty Act found dead; authorizes temporary possession of the dead specimens for transport to a designated public, scientific, or educational institution. Applies to US only (?) Might apply to bird remains from aeroplane engines ('Snarge')? Applies to US only
permits for collecting/taking/possessing/using Term & definition approved Taking: Salvage Permit (e.g., Non-US, US federal, state, local) authorizes the collection of dead animals or animal parts from the wild remove the examples to make it global
permits for collecting/taking/possessing/using Term & definition approved Posessing: Receiving Permit authorizes the acceptance - and holding - of specimens that are subject to special national regulations because a government considered the specimen to be legally restricted (or even illegal) in one way or the other because of their properties (this separates a “receiving permit” from ABS-documents, the latter apply to specimens restricted because of their providing country); and A receiving permit may also imposes certain conditions. In contrast, a certificate of health or (phyto)sanitary certificate rules that a specimen, being legally unrestricted in general, is safe to import with regard to certain pathogen risks. One difference between this document type and ABS documents is that ABS opperates bilaterlaly between countries (though in an international framework), but e.g. drugs and plant(/soil) health are national instruments prohibiting material being held and/or studied/utilised within or entering the country. For example, a “Permit to Receive Soil” issued by the USDA APHIS may authorize the importation of soil from foreign sources (except countries with sanctions or embargoes by U.S. State Department), and interstate/ domestic movement of soil for chemical/ physical analysis in a controlled laboratory environment at the named facility on the permit. Other examples: UK Scheduled Drug licence (e.g. cannabis herbarium specimens). UK Animal and Plant Health Licence. maybe consider extending the definition: what kind of specimens? does this apply only to living specimens and unprocessed products, e.g. fruits? Does this also apply to material preserved in ethanol or fixed with formaldehyde? What is the difference to certificate of health or (phyto)sanitary certificate?; e.g. Foreign Receiving Permit, US Receiving Permit, USDoA Permit to Receive Soil (PPQ 525-A)

IN the CETAF ABS Best Practice there is an MTA that is available for the receiving institution to agree with a donor, and which 'carries' the other necessary documents and declares the right to transfer. Would this fit here, or is it a different concept?
“allows you to receive something that normally you are prohibited to possess” AP Do we need to say special conditions in addition to legislation on Access to genetic resources and Benefit sharing as thats covered elsewhere? THis would still allow includion of CITES registered instituions in this category- or should that be elsewhere too? One difference between this category of things and ABS is thet ABS opperates bilaterlaly between countries though in an international framework, but drugs and plant health are national instruments prohibiting material being held and/or studied/utilised within or entering the country. This view would exclude CITES registration which like ABS is supranational.
FL: Should we add permits to posess illegal living or preserved materials (e.g. plants used for drugs, …) (https://www.natsca.org/policies-legislation)

permits for collecting/taking/possessing/using Term & definition approved Use: Ethical oversight document research review and approval documentation generated by group formally designated to review and monitor research involving e.g. animals (Animal Welfare) both wildlife and lab animals, similar to institutional review board (IRB) and also known as an independent ethics committee (IEC) for humans both wildlife and lab animals, similar to institutional review board (IRB) and also known as an independent ethics committee (IEC) for humans; Todo: check EU or AU for examples Applies to US only
permits for collecting/taking/possessing/using Term approved, check definition Use: Permit to reintroduce/translocate organism into the wild a permit following national or supranational (EU) law to release one or several specimens of a species in a place where they are not present EU regulation on protective measures against pests of plants (REGULATION (EU) 2016/2031), EU regulation on the prevention and management of the introduction and spread

of invasive alien species (REGULATION (EU) 1143/2014), EU regulation concerning the placing of plant protection products on the market (REGULATION (EU) 1107/2009)

usually restricted to a project

I am not sure if all examples (e.g. placing plant protection products on the market) are relevant. In my understanding this document type is about releasing of species in the wild (reintroductions, population reinforcement).
SE21Sept2022: microorganisms and genetically modified organisms released for plant protection purposes seem to be from a legal point of view “plant protection products”

permits for collecting/taking/possessing/using Term approved, check definition Data Use Agreement (DUA) agreement used for the transfer of non-public data that is subject to some restrictions on its use terms and conditions restricting the use of data to be received

terms and condition that govern the transfer and use of data, specifically those that are “confidential, proprietary, or otherwise considered sensitive” (https://researchdatamanagement.harvard.edu/data-use-agreements)

DUAs state the legal framework for data access, what the requestor may do with the data (e.g., scope of the study, restrictions on redistribution), security controls (i.e., obligations to safeguard the data), privacy rights, constraints on publishing and liability for harm arising from the use of the data. They might be accompanied by non-disclosure agreements to guarantee confidentiality over sensitive discussions, information, and data (cp. https://admindatahandbook.mit.edu/book/v1.0-rc4/dua.html , https://research.unc.edu/wp-content/uploads/sites/61/2013/04/CCM3_039360.pdf ).

“Data use agreements (DUA)—also referred to as data sharing agreements or data use licenses—are documents that describe what data are being shared, for what purpose, for how long, and any access restrictions or security protocols that must be followed by the recipient of the data.” (https://admindatahandbook.mit.edu/book/v1.0-rc4/dua.html)[https://research.unc.edu/wp-content/uploads/sites/61/2013/04/CCM3_039360.pdf

]While data licenses are often applicable to openly accessible data, data use agreements are often applicable to data, which access is restricted. A Data Use Agreement (DUA) can be used to set conditions for sharing one's data (see https://www.ru.nl/rdm/vm/licenses-data-use-agreements/.) These conditions do not only apply to data publishing, but also can set rules for how data needs to be handled, eg. some data should not be transferred to a different server, discussed with/made available to other members of a working group, or what type of analyses can be performed (eg. any method resulting in de-anonymization might not be allowed)

“Depending on the data provider, other forms of documentation can be used. Examples include memoranda of understanding (MOU), data use agreements, and data exchange letters. These have different structures and levels of detail, but all of these instruments will state the legal framework for data access, what the requestor may do with the data (e.g., scope of the study, restrictions on redistribution), security controls, and constraints on publishing. The data requestor should always prepare some form of documentation for data access, even if the data provider does not require it” (https://admindatahandbook.mit.edu/book/v1.0-rc4/dua.html).

Data Use Agreement Guidance with lists of topics to consider and flow diagrams for decision processes: https://research.unc.edu/wp-content/uploads/sites/61/2020/06/osr-ic-Data-Use-Agreement-Guidance.pdf

With a focus on data protection: https://www.eui.eu/documents/servicesadmin/deanofstudies/researchethics/guide-data-protection-research.pdf

Data Use Ontology (DUO) with standardized terms for different uses of genomic data: https://github.com/EBISPOT/DUO

A list of aspects to be considered: https://www.ru.nl/rdm/vm/licenses-data-use-agreements/

I would think a DUA concerns any type of data, not only data that is “confidential, proprietary, or otherwise considered sensitive”. For example, a DUA can state that data is in the public domain, or under some kind of open access or restricted licence

JuB: see the changes in green to account for this remark
SE21Sept2022: We probably should talk about this in the next meeting, if DUA really concerns any type of data then we should exclude it like we excluded all intellectual property right items. However, the text in “additional information” seems to indicate that DUA does not concern any type of data

permits for collecting/taking/possessing/using Term approved, check definition Use: bioprospecting permit UNDP described bioprospecting as follows (https://www1.undp.org/content/dam/sdfinance/doc/Bioprospecting%20_%20UNDP.pdf): “Biodiversity prospecting or bioprospecting is the systematic search for biochemical and genetic information in nature in order to develop commercially-valuable products for pharmaceutical, agricultural, cosmetic and other applications. Bioprospecting activities must comply with the definition of utilization of genetic resources of the Nagoya Protocol or as stated in the national law or policy. The Nagoya Protocol applies to the utilization of genetic resources and their derivatives” Existing bioprospecting permits may go beyond the scope of the UNDP description Bioprospecting permits may comprise very different elements, e.g. in South Africa a bioprospecting permit allows to export indigenous biological resources for the purpose of research, and/or allows within South Africa commercialisation of research on indigenous biological resources; in Vanuatu a bioprospecting permit allows collecting, and/or export, and/or import of genetic resources, derivatives and associated traditional knowledge; in Australia/Northern Terr. a bioprocpecting permit allows collecting for scientific research. https://www.dffe.gov.za/sites/default/files/legislations/guide_complete_permitapplication.pdf

https://tradeportal.gov.vu/media/EPC_Act_2002_(consolidated_version_incl_2011_amends).pdf

https://nt.gov.au/environment/native-plants/collecting-plant-materials-for-scientific-research

in South Africa a bioprospecting permit allows to export indigenous biological resources for the purpose of research, and/or allows within South Africa commercialisation of research on indigenous biological resources; in Vanuatu a bioprospecting permit allows collecting, and/or export, and/or import of genetic resources, derivatives and associated traditional knowledge; in Australia/Northern Terr. a bioprocpecting permit allows collecting for scientific research
permits for collecting/taking/possessing/using Term & definition approved Use: Landowner letter signed document that indicates that a researcher has authorization to enter private property and conduct research and/or remove specimens
permits for collecting/taking/possessing/using Term & definition approved Use: Public property use permit legal document such as a permit, term permit, lease, or easement, which allows occupancy, use, rights, or privileges of land; authorization is granted for a specific use of the land for a specific period of time does this permit type exclusively refer to public land use? If so, consider renaming it to “public land use permit” MAT, data use permits, landowner letter and maybe other documents types from this list are at the same time “use permits” to avoid ambiguity, consider deleting or modifying “use permit” // Remark by SE on August 19th, 2022: this remark refers to the time prior to renaming this document type into “public property use permit”
Research Permission Term & definition approved Research Permit authorizes researcher to engage in scientific activity; may specify type of activity or not (collecting, etc.) maybe also place where research will occur, or benefit-sharing obligations; covers a certain time period. Additional permits may be necessary, e,g, for collecting. Important: Research permits could be directed to show compliance with national Access & Benefit-Sharing legislation, these belong to the document type “Prior Informed Consent”, within the document category “Access and Benefit-Sharing document”

Indonesian Foreign Research Permit (https://frp.brin.go.id/),
Botswana Research Permit (http://www.botswanaembassy.org/page/guidelines-for-completing-research-permit-application),
Tanzania Research Permit (https://tawiri.or.tz/),
Victoria(Australia) Research Permit (https://www.vic.gov.au/research-permits),
Brazilian SISGEN system to issue research permits for Brazilians (at the moment foreigners need to be associated with Brazilians researchers) (https://www.gov.br/mma/pt-br/assuntos/biodiversidade/patrimonio-genetico/sisgen https://sisgen.gov.br),
material transfer agreements, stewardships & related inforrmation Review in progress Public law MTA (e.g. acquiring customs' seizures/confiscated material, stewardship agreements, or SMTA for ITPGRFA-purposes) A (often standardised) contract on transferring tangible materials (e.g. specimens or samples) to an institution (rarely an individual), in which a given public authority rules on all (major) terms and conditions stewardship agreement, acquiring customs' seizures
material transfer agreements, stewardships & related inforrmation will be removed Confiscated material documentation e.g. notfication letter from customs
material transfer agreements, stewardships & related inforrmation Review in progress Institutional MTA (e.g. loans) terms and conditions for transferring tangible materials (e.g. specimens or samples) between two legal entities, including permanent/indefinite loans and material to be consumed loans, permanent loans, consumable loans
material transfer agreements, stewardships & related inforrmation Review in progress Deeds of transfer (e.g. private gifts) terms and conditions for transferring tangible materials (e.g. specimens or samples) between two individuals or from an individual to an institution, including private permanent/indefinite loans private gifts, private permanent loans This is also an institutional MTA, and could be combined.
material transfer agreements, stewardships & related inforrmation will be removed Stewardship Documentation document that outline the conditions of agreed curation where ownership is not transferred to the institution curating the material is it possible to differentiate “stewardship” from “permanent loan” by saying that stewardship is assigned by a public authority?

SE21Sept2022: added this to the category type definition

material transfer agreements, stewardships & related inforrmation Term & definition approved Provenance Evidence documentation that establishes how or when a specimen may have been transferred to the museum, indicating provenance but itself does not transfer ownership; not a legal document the document category chosen for this specific document type may be misleading; usually no documentation available this document summarises existing knowledge. // Remark by SE on August 19th, 2022: the document type “provenance evidence” initially was in the document category “transfer of ownership” what about a new document category “posession history”?
Transport Document Term & definition approved (Phyto-)Sanitary/Veterinary Certificate certificate that confirms that an inspection and/or test has been performed and the plant/animal specimens or products are free from regulated diseases or pests e. g. cetificate of health, veterinary permit to transport e.g. “plant passport”; does this apply only to living specimens and unprocessed products? Does this also apply to material preserved in ethanol or fixed with formaldehyde?
Transport Document will be deleted Certificate of Health agricultural certificate that indicates that specimens are in accordance with any regulations regarding health
Transport Document will be deleted Veterinary Permit to Transport USDA permit allowing transport of material across state lines. In GB, EU such permits may be necessary in times of an yet uncontrolled outbreak of veterinary dieseases
Transport Documents Term approved, check definition Permit to move across boundaries document that allows the movement of regulated species across boundaries within and between countries. e.g. injurious wildlife, biological control organisms, invasive and/or pest species e.g. injurious wildlife, biological control organisms, invasive and/or pest species
Transport Documents Review in progress CITES export permits & re-export certificates CITES export permits allow the export of specimens of a species included in CITES-Appendices I, II, or III; re-export certificates apply to corresponding specimens that have previously been imported CL: there appear to be more permits than we have listed - see https://cites.org/sites/default/files/eng/prog/exemptions/SUMMARY-OF-USE-OF-PERMITS-CERTIFICATES-IN-CITES-2018.pdf
Transport Documents Review in progress CITES import permits CITES import permits allow importing specimens of a species included in CITES-Appendix I
Transport Documents Review in progress CITES certificates of scientific exchange (COSE) for institutions registered by a Management Authority of their state, and therefore entitled to the CITES-exemption (article VII, para 6) for non-commercial loans, donations or exchanges between scientists or scientific institutions. (non-registered institutions need permits for export, import, re-export and certificates of origin)
Transport Documents Review in progress other CITES documents CITES documents different from: export/re-export/import/COSE. Among these are 1) “Certificates of Origin” for specimens of species included in CITES Appendix III, 2) certificates for the “Introduction from the sea” of specimens of a species included in Appedices I or II, 3) “Pre-Convention certificates” for acquisition before CITES applied, 4) “Travelling exhibition certificates”, or 5) certificates for specimen of an animal species bred in captivity / specimen of a plant species artificially propagated.
Transport Documents Term & definition approved Original Export Permit authorizes exporting specimens abroad from provider country; CITES Export Permit; Trophy Export Certificate; Edmund Schiller (6.10.2021): is a CITES export permit valid only in connection with an equivalent CITES import permit? In that case I would not unify it with other export permits that do NOT require equivalent import permits, but create a separate document category “CITES” which could contain CITES export permits, CITES import permits, CITES certificates of scientific exchange, and material transfer agreements for acquiring customs' seizures (from situations where customs transfers previously seized CITES material to a museum); initial export from country of origin to institution at time of collection
Transport Documents Term & definition approved Export Permit an export permit for material already belonging to natural history museums or bot. gardens, e.g. institutional exchange, loans etc.; CITES Certificate of Scientific Exchange (COSE); US Fish & Wildlife Form 3-177 based on the Endangered Species Act (ESA);
Transport Documents Term & definition approved Original Import Permit initial import to the institution at time of collection; e.g. Centers for Disease Control (CDC) Import Permit; CITES Import Permit; US Fish & Wildlife Form 3-177; Veterinary Permit to Import;
Transport Documents Term & definition approved Import Permit import permit for material already belonging to natural history museums or bot. gardens, e.g. institutional exchange, loans etc.; Frederiks example CITES Certificate of Scientific Exchange (COSE); US Fish & Wildlife Form 3-177 based on the Endangered Species Act (ESA); Including permits to transport illegal material (drugs, ivory, …)
Exemption Permission (alternative option: Exemption Evidence?) Term approved, check definition Exemptional Authorization authorizes that an action does not require specific permits or documentation Letter that confirrms that documentation establishes that the marine mammal parts were taken prior to

the effective date of the US Marine Mammal Protection Act or US Endangered Species Act and as such, the prohibitions to sell, import, or export these items under the MMPA and ESA do not apply

Declaration might work better?

SE21Sept2022: personally, I like that better, but the suggested “exemption evidence” at the beginning seems the best to me

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