Nagoya Checklist Part 1

Determine whether the material is a non-human genetic resource (“GR”) that originates from outside the UK that may be subject to obligations under the Nagoya Protocol (NP).

A pilot digital checklist (sign in required) is available.

Decision tool

QuestionAction 

A. Is the material any type of genetic resource (GR)?

A GR is material that is (or compromises a sample or extract of) any of the following. Answer yes if the material is any of the following:

  1. domesticated or cultivated animals
  2. cultivated plants or crops
  3. laboratory strains  e.g., lab mice, primary cell line, plasmid containing genetic material or other genetically modified organisms
  4. human microbiota
  5. plant genetic resource for food and agriculture (PGRFA) (defined in Plant Treaty
  6. influenza virus with human pandemic potential
  7. wild plants, fungi, fish, animals, insects, microrganisms, virus  
  8. soil, water, air or other environmental samples that may contain GR
  9. forest reproductive material or marine samples that may contain GR
  10. GR obtained from an ex situ collection
  11. GR obtained from a registered collection
  12. derivative of a GR (e.g. sequencing data, proteins, enzymes, formulation ingredients from a GR)
  • If no, end tool
  • If PGRFA or influenza virus, go to question G
  • If GR from registered collection, go to J
  • If any other type of GR or unsure, go to question B.
 

B. Does the material originate from the UK or USA?
  • If no, go to question C
  • If yes, complete Part 2.2 to end tool.
 

C. Does the material originate from a country labelled dark green or light green (light green) on this map webpage? (Sign in required to view the map.)

Caution:

  • If your use of the GR includes associated traditional knowledge (aTK), do not use this map. Go to question D.
  • If lab strain, check the lab strain table on this webpage.
  • If dark green, complete Part 2.2 to end tool
  • If light green, complete Part 3 to end tool
  • Otherwise, go to question D.
 

D. Is the material one of the following:

  1. human microbiota
  2. lab strain (e.g lab mouse)?
  • If human microbiota, go to question E.
  • If lab strain, go to question F.
  • If neither, go to question H.
 
E. Refer to the UK guidance to judge whether your use of the human microbiota constitutes non-human or human material.
  • If non-human, go to question H
  • If human, go to O.
 
F. Was your access (or will your access) to the lab strain be on or after 12 October 2014?
  • If yes, go to question I.
  • If no, complete Part 2.2 to end tool
  • Seek advice from RGT as appropriate.
 
G. Is the use of the GR covered by a specialised international ABS instrument (i.e., PGRFA under ITPGRFA or influenza virus with human pandemic potential under PIP Framework?
  • If yes, complete Part 2.3 to end tool.
  • If no, question B.
  • If unsure, seek advice.
 
H. Was or will your access to the material be on or after 12 October 2014?
  • If yes, go to question I
  • If no, go to M.
 
I. Check if the provider country is a Party (has signed up to) to the Nagoya Protocol on the ABS Clearing House ABS Clearing House here (Green = Party)
  • If yes, go to question J
  • If no, go to P
 

J. How will you obtain the GR?

  1. From a registered collection that is recognised in the UK or the EU [Check EU register and the UK register]
  2. Non-registered collection or any other source
  • If from Registered collection, part 3
  • Otherwise, go to question K
 
K. Does the research activity (see note 2) constitute utilization (see note 3) of the GR? 
  • If yes, go to Part 3
  • If no or unsure, go to L
 
L. Will the material be held in a museum collection or registered collection to be made available for research and development?
  • If yes, go to Part 3
  • If no, go to N.
 

After answering questions A to L

Based on your answers to the questions above, you should do one of the following:

  • Go to the relevant section in Part 2 to complete the Nagoya Checklist.
  • Complete Part 3 of the Checklist to support the submission of an ABS application to access the genetic resource.
  • Read the relevant box in the dropdown menu below (M, N, O and P)
  • Seek advice from the Research Governance Team (RGT).

Outcomes (M to P)

Your answers indicate that the provider country is a Party to the NP but that your access to the GR pre-dates the Nagoya Protocol. Read the note below about NP countries whose country-specific ABS requirements pre-date NP and complete Part 2.1 to end tool.

Country-specific ABS Requirements that pre-date NP

A provider country might have national access regulations relating to the GR collected prior to October 2014 (e.g. Brazil and India). It is necessary to check and comply with country-specific ABS requirements. Seek advice from research governance team where necessary.

[Exception: If using GR from mainland Spain or France (rather than their other territories, e.g. islands), it is not necessary to do any further checks. The Spanish and French requirements do NOT pre-date the Nagoya Protocol.]

Your answers indicate that your work is out-of-scope of the UK ABS (Nagoya Protocol) regulation because it does not constitute utilisation. Read the note below about country-specific ABS requirements and complete Part 2.4 to end the Checklist.

Country-specific ABS Requirements regarding use

  • Your use of the GR might still be in scope of the provider country’s ABS rules e.g. Taxonomy in Uganda.
  • It is necessary to check and comply with country-specific ABS requirements.
  • Seek advice from research governance team where necessary.

[Exception: If using GR from mainland Spain or France (rather than their other territories, e.g. islands), is not necessary to do any further checks. There aren’t any county-specific ABS rules for the non-utilization uses of GR.]

Your answers indicate that your work is out-of-scope of UK Nagoya Protocol regulation because your research involving human microbiota doesn’t constitute ‘utilisation’.

Read the note below about checking the country-specific ABS requirements of non-NP countries and complete Part 2.4

Country-specific ABS Requirements regarding use of human microbiota

  • Your use of the GR might still be in scope of the provider country’s ABS rules.
  • It is necessary to check and comply with country-specific ABS requirements. Seek advice from research governance team where necessary.
  • If using human microbiota GR from mainland Spain or France, your work does not fall in scope of country-specific ABS requirements of either country.

Your answers indicate that the country is not a Party to NP.

Read the note below about checking the ABS requirements of non-NP countries and complete Part 2.2 to end tool.

Non-NP Country-specific ABS Requirements

Several non-NP countries have ABS requirements (e.g. Australia, Canada etc.) It is necessary to comply with any country-specific ABS requirements. Seek advice from research governance team where necessary.

Decision tool notes

Note 1

In addition to NP ABS requirements, there may be stricter country-specific ABS requirements. The outcomes here specifically address the NP ABS requirements. It is necessary to check and comply with country-specific ABS requirements.

Note 2

For further guidance on specific research activities, please see the UK guidance – the following sections will be particularly of interest to many academic research projects: taxonomic identification of a genetic resource (Section 6.4), Characterisation (section 6.5), Phylogenetic analysis (Section 6.7), Large-scale screening (section 6.8) and testing and reference tools (section 7.9)

Note 3

Utilisation means conducting research and development in which investigation of the genetic or biochemical composition of the genetic material or its derivatives is the object of the research, including through application of biotechnology. Please see the UK guidance (see footnote 2 to help navigate to the relevant section).

Note 4

A number of countries are in the process of implementing their ABS laws. Please be aware that if the ABS law comes into force during your project, your project may then fall into scope of the UK regulation. In such cases, seek confirmation from the relevant authority whether the law has been implemented before each time you wish to collect or transfer samples as part of this project to ensure ongoing compliance.