Permits and Contracts and Terms for Biological Specimens
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Revision as of 14:06, 22 February 2023 by A.Plank (talk | contribs) (A.Plank moved page Permit and Loan Terms (Handbook) to Permits and Contracts and Terms for Biological Specimens: agreed with Edmund Schiller)
(Technical note: work in progress to import neccessary documents and tables for this handbook --A.Plank (talk), 5 January 2023 (CET))
Introduction
This page informs about the contents of this file, possible ways of implementing it in institutions, and the timeline
The basis for the work in this folder (creating a typology of legal/contractual stipulations for biodiversity) 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:
- Biodiversity Permit/Contract Typology (overview)
- Biodiversity Permit/Contract Typology (final)
- Typology of Legal/Contractual Terms for Biodiversity Specimens (draft)
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
Flexibility for natural history collections
- For some institutions the document types may be too detailed, these institutions are free to use only document categories;
- others may implement only certain document types, skipping the ones they currently do not need;
- from the standardised permission/loan conditions (Typology of Contents) only a selection may be applicable to a specific institution, the institution certainly is free to abstain from implementing the others.
- The typology of Contents provides the possibility (not an obligation!) to add “legal background” information for each standardised permission condition allocated to a collection item, e.g. that the permission for utilising a specific genetic resource (in the meaning of the Nagoya Protocol) is based on an individual permit document, or on written law, or on the fact that such utilisation is not legally regulated.
- Every institution is free to select the extent of implementing the “legal background” elements of the Typology of Content according to their needs and resources, they may be implemented only for selected permission conditions, only for selected collection items (e.g. newly collected), only for internal use (to avoid liability disputes), or for any mixture of these options. In general, providing “legal background” information enables estimating the legal certainty of the indicated permission condition and possible ways of verifying it. For example, a permission based on written law always includes some interpretation of the law - less certainty than an individual permit -, but at the same time the law usually is publicly accessible for verification.
- it is inevitable (because resources were scarce in the task group developing this system) that new document types, document categories, permit/loan conditions must be defined and added in the future
- Science is highly integrated on an international level, modifying single definitions for these standardised document categories, document types and permission/loan conditions should only be done after consulting as many partners from other countries as possible, to maintain consistent understanding.
Timeline
| finished by | ||
|---|---|---|
| MS38: written suggestion for a revised version of GGBN’s loan/permit document standard | Oct. 25th, 2022 | delayed to Dec. 2nd |
| MS37: OpenDS element specifications (“Typology of Contents”) covering loan and restriction information agreed by all partners | End of November 2022 | delayed to Dec. 9th |
| Deilverable 3.3: Recommendations for using an improved GGBN Data Standard to provide restriction and loan information | Jan. 13th, 2023 | draft available Dec. 19-21 |
https://wiki.ggbn.org/ggbn/GGBN_Data_Standard_v1#GGBN_Permit_Vocabulary
EU specific permits
| Permit name | Form Name | URL | Mapped to (document type) |
|---|---|---|---|
| Phytosanitary certificate for import into EU (issued by the country from which the plant, plant product or other object originates) | Model phytosanitary certificate for export [to the EU] as referred to in Article 76(1) of Regulation (EU) 2016/2031 | ||
| Phytosanitary certificate for import into EU (issued by a country from which the plant, plant product or other object DOES NOT originate) | Model phytosanitary certificate for re-export [to the EU] as referred to in Article 76(1) of Regulation (EU) 2016/2031 | ||
| Phytosanitary certificate for export from the EU | Phytosanitary certificate for export as referred to in Article 100(3) of Regulation (EU) 2016/2031 | https://assets.ippc.int/static/media/files/reportingobligation/2019/12/17/Export_Certificate.pdf | |
| Phytosanitary certificate for re-export from the EU | Phytosanitary certificate for re-export as referred to in Article 101(4) of Regulation (EU) 2016/2031 | https://assets.ippc.int/static/media/files/reportingobligation/2019/12/17/Re-Export_Certificate.pdf | |
| Plant passports for movement within the Union territory as referred to in the first subparagraph of Article 83(2) of Regulation (EU) 2016/2031 | Plant Passport | ||
| Plant passports for movement into and within protected zones as referred to in the second subparagraph of Article 83(2) of Regulation (EU) 2016/2031 | Plant Passport — PZ | ||
| EU Member State's import permit for European Union quarantine pests as referred to in Art. 8 of Regulation (EU) 2016/2031 |
US specific permits
| Permit name | Form Name | URL | Mapped to (document type) |
|---|---|---|---|
| US Fish and Wildlife Service declaration for importation or exportation of Fish or Wildlife (comment ¹) | USFWS Form 3-177 (Rev. 10/2017) | https://www.fws.gov/le/pdf/3177.pdf | Import Permit |
| Native Endangered and Threatened Species - Scientific Purposes, Enhancement of Propagation or Survival Permits |
USFWS Form 3-200-55 | https://www.fws.gov/forms/3-200-55.pdf | |
| Import/Transport Of Injurious Wildlife | USFWS Form 3-200-42 | https://fwsepermits.servicenowservices.com/sys_attachment.do?sys_id=d66c47b21b61705098dd859ce54bcb08 | |
| INTERSTATE OR FOREIGN COMMERCE OF LIVE ANIMALS/SAMPLES/OR PRODUCTS | USFWS Form 3-200-37d | https://fwsepermits.servicenowservices.com/sys_attachment.do?sys_id=bda72ebe1b6d305098dd859ce54bcb03 | |
| Take/Import/Export of Marine Mammals for Public Display, Scientific Research, Enhancement, or Rescue/Rehabilitation/Release Activities or Renewal/Amendment of Existing Permit (MMPA and/or ESA) |
FWS Form 3-200-43 | https://fwsepermits.servicenowservices.com/sys_attachment.do?sys_id=48845ffe1b61705098dd859ce54bcb9d | |
| Migratory Bird Special Purpose-Salvage | FWS Form 3-200-10a | https://fwsepermits.servicenowservices.com/sys_attachment.do?sys_id=0f194a5a1b782050deacddb6bc4bcb7e | |
| Migratory Bird Import / Export | FWS Form 3-200-6 | https://fwsepermits.servicenowservices.com/sys_attachment.do?sys_id=8c205a161bb82050deacddb6bc4bcbd9 | |
| Migratory Bird and Eagle Scientific Collecting | Form 3-200-7 | https://fwsepermits.servicenowservices.com/sys_attachment.do?sys_id=a88c03b01b92a8509407eb9ce54bcba8 | |
| Import/Export/Re-Export of Biological Specimens (CITES/ESA) for Scientific Research | FWS Form 3-200-37e | https://fwsepermits.servicenowservices.com/sys_attachment.do?sys_id=b3c6477a1b21705098dd859ce54bcb6a |
Comments
↑ ¹ ) “We strongly encourage all filers to use the U.S. Fish and Wildlife Service electronic filing system (eDecs) to reduce paper and time. Filers may access the internet filing system at https://eDecs.fws.gov/.”
Glossary
- ABS Clearing House
- Global information portal (https://absch.cbd.int) developed under the Convention on Biological Diversity (CBD) and further elaborated in the Nagoya Protocol (NP) to make information available on national contacts (especially National Focal Points and Competent National Authorities), national legislation and other matters relevant to Access and Benefits Sharing and the Nagoya Protocol
- Access to genetic resources or associated trad. knowledge
- The acquisition of genetic resources or associated traditional knowledge from the country that has sovereign right over those resources (providing country). Note that this term may be used differently by some countries or organisations. The EU Regulation defines access as ‘the acquisition of genetic resources or of traditional knowledge associated with genetic resources in a Party to the Nagoya Protocol’. Both the → Convention on Biological Diversity (CBD) and - in more detail - the → Nagoya Protocol (NP) contain provisions for granting access to genetic resources.
- Access and Benefit-Sharing (ABS)
- A system based on public international law that outlines the way in which genetic resources or (where applicable) traditional knowledge associated with such resources is accessed and how the benefits that result from the utilisation of such resources and associated traditional knowledge are shared with the countries and/or indigenous peoples and local communities providing them.
- Biodiversity Beyond National Jurisdiction (BBNJ)
- An international agreement, currently at the time of writing this glossary in 2022 under negotiation at the United Nations, on the conservation and sustainable use of marine biological diversity of areas beyond national jurisdiction.
- Bioprospecting
- The search for potentially valuable genetic data and biochemical compounds in biodiversity for the purpose of developing economically valuable products for different applications (e.g. pharmaceutical, cosmetic, agricultural). The UNDP defined bioprospection “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” (https://www1.undp.org/content/dam/sdfinance/doc/Bioprospecting%20_%20UNDP.pdf (archived 20220416), https://de.scribd.com/document/505930765/Bioprospecting-UNDP)
- Convention on Biological Diversity (CBD)
- International agreement designed to promote three goals, the “conservation of biological diversity, the sustainable use of its components and the fair and equitable sharing of the benefits arising out of the utilization of genetic resources” (https://www.cbd.int/convention/text/). The agreement was adopted by the states that participated in the 1992 UN Conference on Environment and Development in Rio de Janeiro; it entered into force on 29 December 1993.
- Convention on International Trade in Endangered Species of Wild Fauna and Flora (CITES)
- International agreement designed to ensure that international trade in wild fauna and flora does not deteriorate the situation of endangered or strongly exploited species. CITES resulted from a resolution by the World Conservation Union (IUCN) in 1963; it entered into force on 01 July 1975.
- Environmental sample
- A collected volume of water, soil, sediment, or any other material containing living our death organisms, or genetic material such as DNA.
- Genetic resources (GR)
- Term identified in the → Convention on Biological Diversity (CBD) and refers to all “genetic material of actual or potential value”, thus encompasses “any material of plant, animal. microbial or other origin containing functional units of heredity” that is potentially valuable to humans. Genetic resources can be taken from the wild, domesticated or cultivated. They may be sourced from natural environments (in situ) or human-made collections (ex situ) (e.g. botanical gardens, gene banks, seed banks and microbial culture collections).
- International Treaty on Plant Genetic Resources for Food and Agriculture (ITPGRFA)
- Also referred to as the Plant Treaty or Seed Treaty. International agreement designed to promote the “conservation and sustainable use of plant genetic resources for food and agriculture and the fair and equitable sharing of the benefits arising out of their use, in harmony with the Convention on Biological Diversity, for sustainable agriculture and food security” (https://www.fao.org/3/i0510e/i0510e.pdf). It entered into force on 29 June 2004.
- Mutually Agreed Terms (MAT)
- Mutually Agreed Terms (MAT) is a contract on benefit-sharing from the utilisation of genetic resources that has been mutually agreed between providers and users of genetic resources in the context of the Convention on Biological Diversity (CBD) including Nagoya Protocol (NP). See typology of Mutually Agreed Terms (MAT).
- Nagoya Protocol (NP)
- Short for “The Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from their Utilization”. An international agreement related to the → Convention on Biological Diversity (CBD), which primarily aims at sharing the benefits arising from the utilisation of genetic resources in a fair and equitable way (https://www.cbd.int/abs/text/). It entered into force on 12 October 2014.
- Pandemic Influenza Preparedness framework (PIP)
- International instrument that aims to “improve pandemic influenza preparedness and response” by improving and strengthening a system for the global sharing “of H5N1 and other influenza viruses with human pandemic potential and access to vaccines and sharing of other benefits” (https://apps.who.int/iris/rest/bitstreams/1351857/retrieve). It was negotiated by Member States of the World Health Organization (WHO) and entered into force on 24 May 2011.
- Phytosanitary
- Scientific and regulatory frameworks relating to plant health, including the control of plant pests or pathogens.
- Prior Informed Consent (PIC)
- A written permission, e.g. given by a government authority of a provider country to a user prior to and allowing access to genetic resources for their utilisation aso.; or for traditional knowledge (approval and involvement of indigenous peoples aso.); or it can also be the leading part of a combined document covering the contents of Mutually Agreed Terms (MAT) as well. See typology of Prior Informed Consent (PIC)
- Reintroduction
- The intentional release of a species from captivity (e.g. zoo, botanical garden, seed bank) in an area inside its indigenous range from which it has disappeared.
- Translocation
- The intentional movement of a species within its indigenous range to an area where it has disappeared.
- Utilization of genetic resources
- To “conduct research and development on the genetic and/or biochemical composition of genetic resources, including through the application of biotechnology” (“biotechnology means any technological application that uses biological systems, living organisms, or derivatives thereof, to make or modify products or processes for specific use”) as defined in the → Nagoya Protocol (NP).
