New Genomic Techniques (NGTs) Animals and their Agri/food/feed products

The overall intended objective of this survey is to identify near-market (i.e. under research/development) farmed NGT-derived animals and their agri/food/feed products globally for a report being prepared for the European Food Safety Authority (EFSA).

New Genomic Techniques (NGTs) are defined as methods or methodologies "capable of altering the genetic material of an organism" - and "New" is further defined as having been developed after April 2001.

Definitions for “agri/food/feed products”:

Food/feed products are obtained from NGT animals that are farmed for food/feed uses, e.g.:
- meat or milk from mammals (e.g. ruminants, pigs, horses)
- meat or eggs from birds (e.g. broilers, laying hens, turkeys, quails and other fowls)
- meat or eggs from fishes and or invertebrates (e.g. marine/freshwater aquaculture)
- meal or honey from insects (e.g. black soldier fly, honey bee)
Agri products are obtained from NGT animals that are farmed, but not for food/feed uses, e.g.:
- fur animals (e.g. mink)
- ornamental fishes
- sericulture (e.g. silkworms)
- insect frass

Please fill out the survey for each NGT animal/trait combination. Results will be made publicly available in the EFSA report.

✻ = Required

Please indicate your relationship e.g. contribution to the development of or other association with the NGT animal ✻

Developer Government official Academic Expert in Field/Consultant Company Industry Trade Group Special Interest Group Prefer not to state

What is the country/region/economy location of the company/institution responsible for developing the NGT animal? ✻

What is the common name of the NGT animal? (e.g. sheep, pig, pufferfish) ✻

What is the species name of the NGT animal? (e.g. Bos taurus) ✻

What is the breed/strain (e.g. Holstein) of the NGT animal (if applicable)?

What is the name of the gene(s) targeted by the NGT?

What is the trait (phenotype) that is being targeted by this NGT animal? (e.g. resistance to PRRS virus) ✻

What was the NGT that was used in general terms? ✻

CRISPR Cas9 (spCas9) CRISPR Cas12a (Cpf1) ZFN (Zinc Finger Nuclease) TALEN (Transcription activator-like effector nuclease) DNA base editor Other (please elaborate in the next question)

Please provide more details on the specific NGT employed, e.g. ‘CRISPR/Cas9’, and the mechanism of action (e.g. multiple targets, etc.)

Was the NGT animal the result of editing in a developing embryo or derived from cloning an edited cell line? ✻

Embryo edit Cloned cell line Other

Given the following definitions:
1) NGTs creating a double-strand break in the DNA;
2) NGTs achieving genome editing without breaking the DNA double helix or generating only a single-strand DNA break;
3) NGTs inducing epigenomic changes;
4) NGTs acting specifically on RNA;
Using which technique was this NGT animal developed? ✻

1 2 3 4 Other (please explain in the next question)

NGT Other: If you marked other in the question above please explain

Given the following definitions:
SDN-1: Produces a double-stranded break in the genome without the addition of foreign DNA. The spontaneous repair of this break can lead to a modification or deletion, causing gene silencing, gene knockout or a change in the activity of a gene.
SDN-2: Produces a double-stranded break, and while the break is repaired by the cell, a small nucleotide template that is complementary to the target region is supplied, which is used by the cell to repair the break. The template contains one or several small sequence changes in the genomic code, that are copied into the animal's genetic material resulting in a modification of the target gene.
SDN-3: Also induces a double-stranded break in the DNA, but is accompanied by a template containing a gene or other sequence of genetic material. The cell's natural repair process then utilizes this template to repair the break; resulting in the introduction of the genetic material.
SDN-1 and SDN-2 animals do not contain inserted "foreign" DNA, while SDN-3 animals may contain "foreign" DNA - meaning DNA introduced from non-sexually compatible species (i.e. transgenic DNA).
Which SDN type (1, 2, 3) is this NGT animal? ✻

SDN-1 SDN-2 SDN-3 Not applicable

How were genome-editing reagents and repair template (for SDN-2 and SDN-3) delivered to the cell/embryo? (e.g. microinjection, electroporation) and in what form? (e.g. RNP, plasmid, ssODN etc.) ✻

Does the NGT animal carry "foreign" DNA introduced from a non-sexually compatible species (i.e. transgenic DNA)? ✻

No Yes (Please provide detail below)

If YES (the NGT animal carries transgenic DNA), please describe the source (e.g. species, commercial vendor), and nature (e.g. gene, expression cassette, plasmid etc.) of the transgenic DNA?

What is the commercial name of the NGT animal and its agri/food/feed products (if any)?

What is the proposed commercial use (if any) of the NGT animal? (i.e. description of the use of the NGT animal and/or any product that will be commercialised)

What is the name of the company/institution responsible for developing the NGT animal? ✻

Given the following definitions:
1) Commercial stage: NGT applications in farmed animals intended for agri, food and feed uses, currently marketed in at least one country worldwide.

2) Pre-commercial stage: NGT applications in farmed animals intended for agri, food and feed uses, ready to be commercialised in at least one country worldwide but not yet on the market (products that are undergoing authorisation procedures or regulatory review in at least one country).

3) Research & Development stage: NGT applications in farmed animals intended for agri, food and feed uses, at proof of concept stage (e.g. testing gene targets for trait enhancement of commercial interest).

At what stage of development is this NGT animal? ✻

1. Commercial stage 2. Pre-commercial stage undergoing authorisation procedures or regulatory review in at least one country 3. Research and Development stage

Is the NGT animal and its agri/food/feed products subject to regulatory or authorisation procedures? If so, please indicate in which country and the regulatory requirements and at what stage they apply e.g. early R&D, advanced R&D etc. A link to the relevant website will suffice if appropriate. If the product is being commercialised in more than one region or economy, please list all economies. ✻

Please include a link to any peer-reviewed references regarding this NGT animal and its agri/food/feed products, or a link to web pages or articles in which the information regarding this NGT animal is reported (if available).

Please add any additional information you consider important regarding this NGT animal and its agri/food/feed products.

What is your preferred email contact address? This will not be made public and is being collected in case we have follow up questions regarding the NGT application described. ✻

First Name

Last Name