BCH on BCH Forum

Dear BCH users,

Thank you for all your feedback concerning the new "Biosafety Organizations" and "Laboratories" formats.

This time we are concentrating on testing RISK ASSESSMENT (RA) records, namely:

--"Risk Assessment generated by a regulatory process" (which are National Records);
--"Risk Assessment generated by an independent or non-regulatory process" (which are Reference Records).

As you know, “National Records” can be managed by CPB Focal Points, BCH Focal Points and National Authorized Users (NAUs) so the Test Assignment #1 below is for CPB and BCH focal points and NAUs.
“Reference Records” can be submitted by any registered BCH user but must be validated by the Secretariat prior to their publication. So, Test Assignment # 2 is for all registered BCH users (CPB and BCH focal points, NAUs and regular users).


Test Assignment #1: Risk Assessment generated by a regulatory process (for CPB and BCH focal points and NAUs):

IF YOU ARE a CARTAGENA PROTOCOL FOCAL POINT (CPB FP) or a NATIONAL AUTHORIZED USER (NAU), perform the following:

1. Go to https://bch.cbddev.xyz/ and log in to the SUBMIT section.
2. Create a new record: “Risk Assessment generated by a regulatory process”.
3. Once all fields are completed, click on "Publish". Your request will be sent to your BCH Focal Point who will need to approve and publish the record you just created.
4. After the record is published by the BCH Focal Point, go to the SEARCH section and find the RA you have created.
5. Explore the SEARCH interface. Try searching for RA records using various filters.
6. Optional: you can go back to SUBMIT and try editing or deleting your record. But, only the BCH focal point will have the right to approve your changes.

IF YOU ARE a BCH Focal Point, perform the following:

1. Go to https://bch.cbddev.xyz/ and log in to the SUBMIT section.
2. Create a new “Risk Assessment generated by a regulatory process” record. Publish it.
3. Go to the SEARCH section and find the RA you have created.
5. Explore the SEARCH interface. Try searching for RA records using various filters.
6. Go back to SUBMIT and try editing and re-publishing your records. Find the edited record in SEARCH.
7. Explore the SEARCH interface. Try searching for RA records using various filters.
8. Optional: try deleting a record.


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Test Assignment #2: Risk Assessment generated by an independent or non-regulatory process (for EVERYONE: all registered BCH users)

IF YOU ARE A REGISTERED BCH user (any BCH user with an account: focal points, NAUs, general public):

1. Go to https://bch.cbddev.xyz/ and log in to the SUBMIT section.
2. Create a new “Risk Assessment generated by an independent or non-regulatory process” record (try creating reference records inline). Submit it for publishing to the Secretariat. 
3. Once you see that the record is "Published", go to SEARCH and try to find your published record.
4. Explore the SEARCH interface. Try searching for RA records using various filters.
5. Optional: Go back to SUBMIT and try editing your record and then, once your modified record is published by the Secretariat, find your record in the  SEARCH interface again.

DEADLINE: Friday, August 14.

We look forward to receiving your comments.

Thank you and kindest regards,

Anastasia

Dear Anastasia,

Below my feedback after testing the part “Risk Assessment generated by an independent or non-regulatory process”.

1) Creating a biosafety organisation:
I got to the point ‘pending for approval by CBD Sec.
This part works, be it that some things are not self-evident. For example, after hitting the green button ‘Publish’ at the bottom of the page, nothing happened. It appeared that I had to go back to the top of the page to submit a request to the CBD Sec.
Suggestion: under “Regional area”: please add the category: ‘international”..

2) Creating a risk assessment.
“Scope of the risk assessment”
It is good that for the scope pf the ERA you have a category ‘other’, because after having been active in this field for almost 35 years, I know that there will always be categories people haven’t thought of. For example, the proposed distribution of an rDNA rabies vaccine in pieces of meat in Europe in the early 90s was neither a field trial nor a commercial release (and the same will be true for various forms of vector control).

“Methodology and points to consider”

Here I would recommend two types of adjustments:
1) Giving the headings names that are as close as possible to the wording of Annex III of the CPB,
2) Allowing the results of the steps of the risk assessment to be entered in a more systematic and differentiated way. 

Explanation:
The heading of the first entry reads “Potential adverse effects identified in the risk assessment”.

The actual wording of the first step in Annex III is: “An identification of any novel genotypic and phenotypic characteristics associated with the living modified organism that may have adverse effects on biological diversity in the likely potential receiving environment, taking also into account risks to human health “.

This first step of Annex III effectively contains two sub-steps:
a)  Identify novel genotypic and phenotypic characteristics associated with the LMO.
b) Identify which of those novel characteristics may have adverse effects

Identifying novel characteristics looks at the intended changes as well as any unintended changes. An LMO may have one or more novel genotypic and phenotypic characteristics.

Next follows the question which of those novel characteristics may have adverse effects (on biological diversity …etc). A novel characteristic may have none, one or several potential adverse effects. To conduct these steps in a systematic way, risk assessors typically assess per novel characteristic which potential adverse effects that novel characteristic may have.

For each of the identified potential adverse effects, risk assessors evaluate the likelihood of that identified potential effect being realised and of the consequences thereof, followed (still per  identified potential adverse effect) by an estimation of the overall risk and a recommendation as to whether or not the identified risks are acceptable or manageable.

In summary: risk assessments are conduced per novel characteristic and for each of the novel characteristics per identified potential adverse effect.

The current format for entering the steps in the risk assessment combines all of these in single fields, which will make it very difficult to identify which potential adverse effects relate to which novel characteristics, and which evaluations of likelihood relate to which identified potential adverse effect, et cetera. In short, presenting the risk assessment in that way is not consistent with the instruction of Annex III that risk assessments be transparent.

I would therefore advise to change system into a format that starts with an entry to list identified novel genotypic and phenotypic characteristics associated with the LMO, and then continues per novel characteristic with the identification of potential adverse effects, and after that continues per potential adverse effect with the next steps such as likelihood etc.

The nice thing of your database is that it allows to do this in a very systematic way.

Best regards

Piet

Dear Mr. van der Meer,

I apologize for not having responded sooner (I was on vacation holidays).

Thank you very much again for your feedback.

1) The "Publish" button at the bottom is supposed to simply bring you to the top of the Publish page from where you need to click the other green "Publish" button to publish the record. So, it functions correctly.  As for your suggestion about "Regional Areas", the options in that drop-down box are pre-defined by our system and are the same that are used throughout different other clearing houses such as ABSCH and CHM and other sites of the Convention. If you compare it with the old BCH, you will see that there are a lot more options in the new BCH now. There is an option called "Global". There is also "Other" where people can enter an area they haven't found. But we took note of your suggestion.

2) Thank you for your very insightful feedback about the Risk Assessment format. You are the  first person who made these type of comments. We will definitely look into them more carefully.

Kind regards,

Anastasia

Dear Anastasia,

I (NAU) have created a test RA record (“Risk Assessment generated by a regulatory process”, #251074). Entering the record was straight forward and the communication with our NFP (Nina Opitz) through the platform went without any problems. The record was accepted by the NFP and is now displayed as "published".

Then, unfortunately, the search did not go as expected:
My newly created record was displayed on top of the search page (as it is the newest record, I guess) before I used any filters. But when I filtered for Record type (RA generated by a regulatory process) and Country (Germany), I got many hits, but my new record was not one of them.
When I then added either more filters (date of submission (last 7 days)), or if I added keywords ("potato", the word comes up in the title, or "Test RA", which is the beginning of the record's title), I do not get any hits at all. (Or 2 incorrect ones for "test RA", because "test" comes up somewhere in the other records, I guess.)

I do, however, get just that one record as a hit if I search for the record ID, so that worked fine.

I have screenshots of all the different filter settings and search results, if needed.

Best regards,
Nina

Dear Ms. Duensing,

In this message I am replying to you and also to comments made by other users (Ms. Jirakova, Ms. Agbagala, Ms. Guner) concerning the SEARCH filter not working properly (Region, Country, Date, etc.)

I tried to search for your record using various filters as you did and I experienced the same issues as you describe in your message. Yes, there is definitely a problem with he SEARCH filters. We will fix them! From what I know, they are a bit complicated to implement and additional development is required but we will figure it out to make sure they are working properly.

Thank you very much for testing the RA records and alerting us of these issues.

Kind regards,

Anastasia

Thanks to everyone who has already shared comments from testing the process for publishing and searching for risk assessment records. Please be aware that Anastasia is currently taking some well-deserved leave so she will not be replying as quickly as she normally does. Rest assured that we are keeping track of all the comments.

For those who have not yet done the test, there is still time. The deadline is Friday, August 14.

Best wishes,
Kathryn Garforth

(Officer-in-charge, Biosafety unit, CBD Secretariat)

Dear Anastasia,
I did both tests, incl. creation, editing and deletion of records and all work as it should have (I was logged as NFP for CBD and BCH).
Best Regards,
Nikolay

Dear Anastasia,

Thank you for sending us detailed explanation for the testing.  As a CPB FP, I did a test and the result was no problem.  Creation, approval by BCH FP and search the record using various filters went smoothly.

Kind regards,

Fuyumi

Tried submitting RA report by regulatory process and also RA report by independent process. No problems. Was all ok.

Dear Anastasia,

I have tested as the BCH NFP, everything works well for RA publications generated by regulatory and non-regulatory processes.

Best regards,

Galina

Dear Anastasia,
I (CPB and BCH NFP) have performed the test as required. Creating as well as publishing the new record was smooth and very fast. However, I still have problems with filters as they do not work as expected. „No records found“ notification appears if I try to use any of Date / Region / Country filters. I have already encountered same problems in previous formats (Testing Organisation and Labs). Best Regards,
Hana

Dear Anastasia:
I have performed  the test as instructed. Creating and publishing new records were fast and easy. But like Ms Jirakova from Czech Republic, I also encountered the same problem  when I was trying to search for RA records using various filters such as Region/Country filters.

Thank you and best regards,
Maria Lorelie U. Agbagala

Dear Anastasia,

I have finished the test and it was easy/fast. I can access information very quickly from the "SEARCH" section however, I am having problems in the "SEARCH FILTERS" section (Record types, Keyword, Country, Region and Date).

Best regards

Birgül GÜNER
NAU of Turkey

Dear Anastasia,

I tested as the CPB and BCH NFP, everything works very well for Risk Assessment publications generated by regulatory and non-regulatory processes.

Best regards,

Marvin Argueta

Dear Anastasia,

The test assignments were performed and everything worked perfectly well.

Thanks

Blessing Aligwekwe
BCH NFP Nigeria