January 23, 2026
This Decision Document has been prepared to explain the regulatory decision reached under the Feeds Regulations, 2024.
The Animal Feed Program (AFP) of the Animal Health Directorate of the Canadian Food Inspection Agency (CFIA) has evaluated information submitted by PIC-Canada Ltd. This information concerns the Genus PRRSV-resistant pig events, which displays resistance to the porcine reproductive and respiratory syndrome virus (PRRSV). We have determined that feed ingredients derived from this animal with a novel trait do not present livestock feed safety or nutrition concerns when compared to feeds derived from pigs currently permitted to be used as livestock feed in Canada.
On this page
- Brief Identification of the modified animal
- Background information
- Description of the novel trait
- Criteria for the livestock feed assessment
- 4.1 Potential impact of Genus PRRSV-resistant pig events on livestock nutrition
- 4.2 Potential impact of Genus PRRSV-resistant pig events on animal health and human safety as it relates to the potential transfer of residues into foods of animal origin and worker/bystander exposure to the feed
- 4.3 Potential impact of feeds derived from Genus PRRSV-resistant pig events on the environment
- 4.4 Potential impact of Genus PRRSV-resistant pig events on the environment
- 4.5 Conclusion
- New information requirements
- Regulatory decision
- Contact us
1. Brief Identification of the modified animal
Designation of the modified animal: Genus PRRSV-resistant pig events
Applicant: PIC-Canada Ltd
Animal subspecies: domestic pig (Sus scrofa domesticus)
Novel trait: resistance to the porcine reproductive and respiratory syndrome virus (PRRSV)
Trait introduction method: micro-injection of pig embryos and CRISPR-Cas9-based gene-editing
Intended end use: traditional human food and livestock feed uses
2. Background information
PIC-Canada Ltd. has submitted for approval the Genus PRRSV-resistant pig events, which display resistance to infection by the porcine reproductive and respiratory syndrome virus (PRRSV). This resistance protects the pigs from developing porcine reproductive and respiratory syndrome. The Genus PRRSV-resistant pig events were developed using Clustered Regularly Interspersed Short Palindromic Repeats (CRISPR)-Cas9 technology, resulting in a partial deletion of the endogenous CD163 gene. This edited CD163 gene in the Genus PRRSV-resistant pig events encodes a CD163 protein with the scavenger receptor cysteine rich domain 5 (SRCR5) deleted and a single amino acid substituted. As SRCR5 of CD163 is essential for PRRSV's ability to interact with and enter the target cells, deletion of the SRCR5 in the CD163 protein prevents PRRSV from causing infection in the modified pig. To have protection against PRRSV, animals must be homozygous for the gene edit – that is, animals where the edit exists in both copies of the gene.
PIC-Canada Ltd. sought approval for feeds derived from a total of 1406 Genus PRRSV-resistant pigs from the second generation (E1) of animals split across 4 pig breeding lines and for feeds derived from their descendants. PIC-Canada Ltd. has indicated that they are using this approach to maintain herds of the Genus PRRSV-resistant pigs with greater genetic diversity and to prevent inbreeding. PIC-Canada Ltd. has provided a complete list of all the animal identification numbers and has confirmed that each of the 1406 Genus PRRSV-resistant pigs in the second generation has the identical deletion in the target gene and no detectable off-target edits.
PIC-Canada Ltd. has provided information on the identity of the Genus PRRSV-resistant pig events; a detailed description of the gene edit method; and information on edit copy number and intactness, levels of protein expression in the animal and the role of the edited gene. The novel protein was identified and characterized. Information was provided for the evaluation of the potential toxicity of the novel protein to livestock and non-target organisms and the potential allergenicity of the novel protein to humans and to livestock.
A phenotypic study was conducted from birth to sexual maturity at Genus PLC Experimental Farm in 2022. Homozygous and heterozygous Genus PRRSV-Resistant pigs were compared to non-edited pigs and to a commercial wildtype line. Industry-standard phenotypic data, reproductive data and mortality and morbidity rates were assessed. Two nutritional studies were conducted at Genus PLC Experimental Farm and Purdue University Meat Laboratory in 2022. In these nutritional studies, homozygous and heterozygous Genus PRRSV-Resistant pigs were compared to non-edited pigs and to a commercial wildtype line. Carcass quality and loin muscle tissue composition (proximates, amino acids, vitamins, minerals and fatty acids) were evaluated. A supplementary complete blood count study was conducted in 2024 with homozygous and heterozygous Genus PRRSV-Resistant pigs and a commercial wildtype line.
The AFP has considered both intended and unintended effects and similarities and differences between the Genus PRRSV-resistant pig events and unmodified pigs, relative to the safety and nutrition of feed ingredients derived from Genus PRRSV-resistant pigs for their intended purpose, including:
- the potential impacts of Genus PRRSV-resistant pigs on animal health and human safety, as they relate to the potential transfer of residues into foods of animal origin and to worker/bystander exposure to the feed
- the potential impact of Genus PRRSV-resistant pigs on livestock nutrition; and
- the potential impact of feeds derived from Genus PRRSV-resistant pigs on the environment
The AFP also considered whether feeds derived from the Genus PRRSV-resistant pigs meet the descriptions and requirements of feeds as listed and described in the Canadian Feed Ingredients Table (CFIT) under the Feeds Regulations, 2024.
3. Description of the novel trait
3.1 Development method
The Genus PRRSV-resistant pig events were developed through microinjection of ribonucleoprotein complexes of Cas9 nuclease and guide ribonucleic acid (RNA), into one-celled zygotes (fertilized eggs) of wild-type pigs from 4 elite breeding lines. The guide RNAs were designed to target ribonucleoprotein complexes to the intended deletion site in the CD163 gene. No foreign deoxyribonucleic acid (DNA) was introduced and PIC-Canada Ltd. provided detailed information on the absence of DNA in the material microinjected into the zygotes. The boars developed from the edited embryos (E0 generation) were screened for the desired edit and off-target edits, using next generation sequencing technology for short-read sequencing, long-read sequencing and hybridization capture-based sequencing with short-read sequencing. The hybridization capture-based sequencing analysis focused on 182 sites in the pig genome that had been experimentally identified as being higher-risk for off-target edits by the ribonucleoprotein complexes used to edit the CD163 gene. Select boars with the on-target edit were bred with wild-type pigs to generate the second (E1) generation. PIC-Canada Ltd. selected a total of 1406 pigs in the E1 generation that contained the desired edit in the CD163 gene and no off-target edits, as determined by sequence-based molecular analyses, for further breeding to develop the commercial lines of Genus PRRSV-resistant pigs. End-point TaqMan® assays using a polymerase chain reaction (PCR)-based approach were used to determine if animals in the third (E2) generation had none, 1 or both copies of the CD163 gene edited.
3.2 Resistance to PRRSV
PRRSV is the causative agent of porcine reproductive and respiratory syndrome, which can lead to mortality in pigs. To cause infection in the pig, PRRSV must attach to and enter target cells within the pig. In conventional pigs, PRRSV interacts with the CD163 protein that is present on the surface of a subset of immune cells in the monocyte/macrophage lineage and PRRSV uses this interaction to enter these cells and cause infection. In contrast, when the target cells instead express the edited CD163 protein present in the Genus PRRSV-resistant pigs, the PRRSV cannot infect the cells and the pigs do not develop the disease. Data were provided to demonstrate that the edited CD163 protein maintains its other functions. Thus, the gene edit in the Genus PRRSV-resistant pigs confers protection against PRRSV.
The gene edit results in a 105-amino acid deletion and a single amino acid substitution in the CD163 protein. The amino acid sequence of the edited protein was predicted based on the determined sequences of the genomic DNA and the mature messenger RNA (mRNA) transcripts, with the mRNA isolated from whole blood. The decreased molecular weight resulting from the deletion of the amino acids in the edited CD163 protein, compared to the full-length CD163 protein, was demonstrated by western blot analysis of protein from pulmonary alveolar macrophage and monocyte-induced macrophages. Feed ingredients, such as animal fat and mixed animal meat meal, may be derived from pigs and are listed and described as livestock feed ingredients in the CFIT of the Feeds Regulations, 2024, in Canada, so there is a history of livestock feed exposure to CD163 protein from pigs.
Protein expression of the edited CD163 protein in the Genus PRRSV-resistant pigs was compared to the expression of CD163 in pigs not carrying the edited gene. Western blot and semi-quantification of CD163 in pulmonary alveolar macrophages from representative animals with and without the edit showed that expression of CD163 did not significantly differ. Similar analysis of protein from monocyte-induced macrophages, where the isolated cells were differentiated in vitro, also showed that the edit did not result in significant differences in expression of CD163 between cells isolated from animals homozygous for the edit (both copies of the gene edited), heterozygous for the edit (1 copy edited and 1 copy not edited) and homozygous for the unedited CD163 gene. These findings indicate that the edit would not result in an increase in exposure to the CD163 protein in feeds derived from Genus PRRSV-resistant pigs compared to conventional comparators.
The potential allergenicity and toxicity of the edited CD163 protein to livestock and non-target organisms were evaluated, as discussed in section 4. The edited protein is not more allergenic or toxic than the unedited protein. Protein levels did not differ significantly between wildtype and edited pigs. Therefore, no health impact is expected for livestock consuming feed ingredients produced from PRRSV-resistant pigs, for consumers eating products from livestock fed such ingredients or for workers handling these feed ingredients.
3.3 Stability of the edit in the pig genome
Molecular characterization across 3 generations supported the stability of the edit in the pig genome. PIC-Canada Ltd. used sequencing-based approaches, as described above, to assess the edit in the CD163 gene in the E0 and E1 generations. In the E2 generation, analysis of mature mRNA transcripts from whole blood of representative animals confirmed the presence of the expected deletion in the CD163 gene and its resulting effect on the protein-encoding sequence in both homozygous and heterozygous animals. Protein analyses were conducted on pulmonary alveolar macrophages and monocyte-induced macrophages derived from representative E2 animals, to demonstrate the presence of only the edited CD163 protein in homozygous edited animals; the expected non-edited protein in wild-type animals; or both the edited and non-edited versions of the protein in heterozygous animals. End-point TaqMan® assays that use PCR-based analyses were used to screen all animals from the E2 generation onwards. The end-point TaqMan® assays use 2 sets of probes to determine the presence or absence of the edited CD163 gene and the unedited CD163 gene and the results were used to identify the animals based on if they carry 2 copies of the edited CD163 gene (homozygous edited), 2 copies of the unedited CD163 gene (homozygous wild-type) or 1 of each (heterozygous).
The inheritance pattern for the CD163 gene edit was assessed in 4 representative populations of E2 animals supported by genetic analysis results from E2 animals across the entire breeding program. Based on the data provided, the edited CD163 gene was found to segregate according to Mendelian rules of inheritance for a single genetic locus.
4. Criteria for the livestock feed assessment
The AFP considered nutrient and anti-nutrient profiles; the safety of feed ingredients derived from Genus PRRSV-resistant pigs including the presence of gene products, residues and metabolites in terms of animal health and human safety as it relates to the potential transfer of residues into foods of animal origin and worker/bystander exposure to the feed; and whether feeds derived from Genus PRRSV-resistant pigs meet the descriptions and requirements of feeds as listed in the CFIT of the Feeds Regulations, 2024. The potential impact of feeds derived from Genus PRRSV-resistant pigs on the environment was also assessed.
4.1. Potential impact of Genus PRRSV-resistant pig events on livestock nutrition
Nutrient and anti-nutrient composition
Phenotypic comparison
To confirm the lack of unintended effects from the targeted modification of the CD163 protein, a comparative phenotypic study was conducted from birth to sexual maturity at the Genus PLC Experimental Farm in 2022. Homozygous and heterozygous Genus PRRSV-resistant pigs from the second generation of an elite breeding line were compared to unedited pigs from the same line and to pigs from a commercial wild-type line.
Standard phenotypic data were collected from birth to female farrowing, including initial birth weight, number of teats, industry-standard 140-day test measurements including body weight, front leg score, rear leg score, backfat depth and loin depth. Reproductive data, including farrowing data, were also assessed, along with mortality and morbidity.
Statistical modeling and analysis were conducted to generate least-squares means and perform statistical comparisons between zygosity groups, with statistical significance examined at P less than 0.05. The independent effects of gender were tested for inclusion in the statistical model. Where statistically significant differences were identified, comparisons were made to reference data from unedited commercial lines to determine whether the differences were within the range of natural variability in conventional populations.
No statistically significant (P less than 0.05) differences were observed for phenotypic characteristics, with the exception of birth weight, which was lower for CD163 edited pigs compared to wildtype unedited pigs. This difference is explained by the wild-type populations undergoing commercial selection processes for heavier birth weight. No traditional selection was practiced in the CD163-edited E0 and E1 generations.
Carcass quality and nutrient composition (single-line and multiple-line studies)
To confirm that the gene-edited CD163 protein did not alter the nutritional quality of feed ingredients derived from Genus PRRSV-resistant pigs, 2 comparative studies were conducted at the Genus PLC Experimental Farm and Purdue University Meat Laboratory in 2022. In the single-line study, homozygous and heterozygous Genus PRRSV-resistant pigs from the third generation (E2) of an elite breeding line were compared to unedited pigs from the same line and to pigs from a commercial wild-type line. Carcass quality and muscle tissue composition were evaluated. In the multiple-line study, homozygous Genus PRRSV-Resistant pigs from the second generation of 4 elite breeding lines were compared to unedited pigs from the same lines and to pigs from a commercial wildtype line. Carcass quality and muscle tissue composition were evaluated.
Four zygosity groups (homozygous edited, heterozygous edited, homozygous null (unedited) and wild-type unedited were reared under standard commercial conditions from the starter to finisher phase (prior to sexual maturity). Pigs were evaluated at slaughter for hot carcass weight, backfat thickness, loin muscle pH and temperature, loin eye area, loin colour score and loin marbling score. Muscle tissue (loin) samples were collected at 24 hours postmortem for analysis of nutrient composition (proximates, amino acids, vitamins, minerals and fatty acids).
Single-line study
Statistical modeling and analysis were conducted to generate least-squares means and perform statistical comparisons between zygosity groups, with statistical significance examined at the P less than 0.05. The independent effects of gender were tested for inclusion in the statistical model. Where statistically significant differences were identified, comparisons were made to reference data from unedited commercial lines to determine whether the differences were within the range of natural variability in conventional populations.
The following statistically significant (P less than 0.05) differences were observed for carcass quality:
- Muscle temperature at 35 minutes postmortem was greater for the unedited wildtype group compared to other groups. All values were within the reference commercial range.
- Hunter colour redness was greater for the heterozygous edited group compared to other groups. All values were within the reference commercial range.
- Backfat thickness was greater for unedited groups compared to edited groups. All values were within the reference commercial range.
- Loin area was greater for the homozygous null unedited group compared to other groups and was outside the reference commercial range
No statistically significant differences were observed for loin nutrient composition (P greater than 0.05) and all values were within the range of natural variation in the reference commercial lines. Considering the similarity in loin muscle nutrient composition, the increase in loin area for the homozygous null unedited group is not considered relevant in terms of nutritional equivalence of derived feed ingredients.
Multiple-line study
Statistical modeling and analysis were conducted to generate least-squares means and perform statistical comparisons between zygosity groups, with statistical significance examined at P less than 0.0033 after Bonferroni multiple-test correction. The independent effects of gender were tested for inclusion in the statistical model. Where statistically significant differences were identified, comparisons were made to reference data from non-edited commercial lines to determine if the differences were within the range of natural variability of conventional populations.
The following statistically significant (P less than 0.0033) differences were observed for carcass quality:
- Line 02, muscle pH at 24 hours was greater for the edited group compared to the un-edited wildtype. All values were within the reference commercial range.
- Line 02, Hunter colour lightness was greater for the un-edited wildtype group compared to the edited group. All values were within the reference commercial range.
The observed carcass quality differences in 1 of the 4 lines were within the range of natural variation in the reference commercial lines and therefore, are not considered relevant in terms of nutritional equivalence of derived feed ingredients. No statistically significant (P less than 0.0033) differences were observed for loin nutrient composition and all values were within the range of natural variation in the reference commercial lines.
Complete blood count (multiple-line comparison)
A supplementary study was conducted in 2024. Homozygous and heterozygous Genus PRRSV-resistant pigs from the second generation of 4 breeding lines and unedited wildtype pigs from the same lines, were reared in standard commercial conditions. At 5 months of age, fasting blood samples were collected from female pigs.
Sixteen complete blood count parameters were evaluated: white blood cell counts, red blood cells, hemoglobin, hematocrit, mean corpuscular volume, mean corpuscular hemoglobin, mean corpuscular hemoglobin concentration, red cell distribution width, platelets, average platelet size, neutrophils, lymphocytes, monocytes, eosinophils, basophils and absolute leukocytes.
Statistical modeling and analysis were conducted to generate least-squares means and perform statistical comparisons between zygosity groups, with statistical significance examined at P less than 0.05 after Bonferroni multiple-test correction. Where statistically significant differences were identified, comparisons were made to reference data collected from Iowa State University (ISU) Clinical Pathology Laboratory to determine if the differences were within the range of natural variability of conventional populations.
The following statistically significant (P less than 0.05) differences were observed for blood counts:
- Line 65, hemoglobin was greater for the wildtype group compared to the edited groups. All values were within the reference commercial range and therefore not considered biologically relevant.
There were no significant differences in the other blood parameters, including monocyte levels, between edited and unedited pigs.
The study data presented by PIC-Canada Ltd. and summarized above supports the conclusion that the targeted edit of the CD163 protein to confer PRRSV resistance had no unintended effects on pig phenotype, carcass quality, muscle composition or blood profile. This result was expected, as the modified CD163 gene is expressed exclusively in monocytes and macrophages and the deleted SRCR5 domain functions specifically in PRRSV-resistance and is not involved in other biological functions.
There were no significant differences observed in muscle tissue nutrient composition. The small number of differences observed in carcass quality and blood count were not observed across all 4 lines studied and where differences were observed, they were within the range of natural variability in commercial unedited pig populations. Therefore, these differences are not considered biologically relevant and are not likely to impact the nutrient composition of livestock feed ingredients derived from Genus PRRSV-resistant pigs.
Conclusion
Based on the evidence provided by PIC-Canada Ltd., the composition of Genus PRRSV-resistant pigs is similar to that of conventional commercial pig populations. Feed ingredients derived from Genus PRRSV-resistant pigs are expected to have a nutritional composition equivalent to those feed ingredients derived from conventional pigs.
4.2. Potential impact of Genus PRRSV-resistant pig events on animal health and human safety as it relates to the potential transfer of residues into foods of animal origin and worker/bystander exposure to the feed
Genus PRRSV-resistant pigs display resistance to PRRSV due to the partial deletion of the CD163 gene. The assessment of Genus PRRSV-resistant pigs evaluated the impact of the following potential hazards relative to the safety of feed ingredients derived from this event:
- the partial deletion of the CD163 gene with respect to PRRSV
- the impact of the deletion on other CD163 gene functions
- the impact on the contaminant profile in feeds derived from Genus PRRSV-resistant pigs
Modified CD163 protein
The potential allergenicity and toxicity of the edited CD163 protein to livestock and non-target organisms were evaluated. The weight of evidence indicates that this edited CD163 protein is unlikely to be allergenic, based on the following information. Neither the edited nor unedited CD163 proteins matched known allergens in bioinformatics searches.
It was also concluded that this edited CD163 protein is unlikely to be toxic to livestock and non-target organisms because it lacks a mode of action to suggest that it is intrinsically toxic to livestock or non-target organisms. In addition, unedited CD163 has a history of safe use in livestock feeds and in human foods. Livestock exposure to the edited CD163 is expected to be negligible as CD163 is expressed only in monocytes and macrophages. There was no difference in the expression levels of the edited and unedited CD163 proteins. Both edited and unedited CD163 were stable when heated at 95°C for 30 minutes. However, both edited and unedited CD163 were rapidly digested by pepsin, indicating the proteins would be hydrolyzed in the digestive tract. This indicates the exposure to the edited and unedited CD163 proteins would be limited.
In addition to these factors, the assessment of the potential toxicity of CD163 also considered the health status of the Genus PRRSV-resistant pigs. Animal health is an indicator of the safety of derived feeds and the practice of only allowing animals with known and acceptable health status to enter the feed supply is an essential step in ensuring safe feed. It was concluded in an animal health assessment performed by Health Canada that the Genus PRRSV-resistant pigs were as healthy as unedited pigs. In addition, disease challenge studies showed that pigs homozygous for the CD163 gene edit are resistant to the PRRSV strains used in the studies, whereas heterozygous and homozygous wildtype pigs were susceptible to the virus. Thus, the safety of feed products derived from Genus PRRSV-resistant pigs is supported by a health status assessment.
Impact of edited CD163 protein
CD163-positive cells can be found in pulmonary alveoli, spleen red pulp, liver hepatic sinusoids, tonsils, nasal mucosa and placenta. The deletion of exon 7 of CD163 results in a mature expressed CD163 protein that is lacking the SRCR5 domain necessary for PRRSV infection, while all other CD163 protein domains remain unchanged. The CD163 protein is also involved in the clearance and endocytosis of hemoglobin/haptoglobin complexes by macrophages and may thereby protect tissues from free hemoglobin-mediated oxidative damage. However, the deletion of the SRCR5 region did not affect macrophage differentiation nor impair the uptake of hemoglobin through the hemoglobin-haptoglobin complex. CD163 is also involved in other processes, but it is not expected that the edit would impact these processes. As well, data regarding animal health, nutritional composition and blood parameters further corroborated the lack of unintended effects. Feed ingredients made from these pigs are not expected to adversely affect livestock, humans consuming those livestock or humans handling the feed.
No adverse effects were observed in pigs homozygous for the edited CD163 when the pigs were maintained under standard animal husbandry conditions.
4.3. Potential impact of feeds derived from Genus PRRSV-resistant pig events on the environment
Feed ingredients derived from Genus PPRSV-resistant pigs have been assessed to be equivalent to those derived from conventional pig sources in terms of their nutritional composition and contaminant profiles. Therefore, the use of these ingredients in livestock feeds is comparable to conventional feed ingredients derived from pigs with no greater environmental impact than feed ingredients derived from conventional pig sources.
4.4. Potential impact of Genus PRRSV-resistant pig events on the environment
The Canadian Environmental Protection Act, 1999 (CEPA 1999), administered by Environment and Climate Change Canada (ECCC) and Health Canada, is the primary legislation through which the Government of Canada ensures that all new substances, including organisms, are assessed for their potential harm to the environment and human health. The New Substances Notification Regulations (Organisms) [NSNR (Organisms)] under CEPA 1999, specify the information that must be submitted to ECCC prior to the import or manufacture in Canada of new organisms that are animate products of biotechnology, including pigs derived from biotechnology. ECCC is responsible for evaluating the environmental impact of the Genus PRRSV-resistant pigs.
4.5 Conclusion
It was concluded, based on the evidence provided by PIC-Canada Ltd., that the edited CD163 protein does not confer any characteristics to pigs that would raise concerns regarding the safety or efficacy of feed derived from these animals. Feed ingredients derived from Genus PRRSV-resistant pigs are considered equivalent to current feed ingredients derived from conventional pigs and are expected to meet existing ingredient descriptions.
5. New information requirements
If at any time PIC-Canada Ltd. becomes aware of any new information regarding risk to the environment, livestock or human health, which could result from the livestock feed use of Genus PRRSV-resistant pigs or lines derived therefrom, PIC-Canada Ltd. is required to immediately provide such information to us. Based on such new information, we will re-evaluate the potential impact of Genus PRRSV-resistant pigs on the environment, livestock and human health and may re-evaluate its decision with respect to the livestock feed use authorization of Genus PRRSV-resistant pigs.
6. Regulatory decision
Based on the review of the data and information submitted by PIC-Canada Ltd. and input from other relevant scientific sources, the Animal Feed Program of the Animal Health Directorate, has concluded that the edited CD163 protein conferring resistance to PRRSV will not confer to swine any characteristic that would raise concerns regarding the safety or efficacy of feed ingredients derived from swine. Livestock feeds derived from swine are currently listed and described in the CFIT. Genus PRRSV-resistant pigs have been found to be as safe as and as nutritious as currently and historically grown swine. Genus PRRSV-resistant pigs and their products are considered to meet present ingredient descriptions in the CFIT.
Considering this evaluation, feed ingredients derived from Genus PRRSV-resistant pigs are therefore authorized by the AFP of the Animal Health Directorate of the CFIA as of January 23, 2026 for use in livestock feeds. Livestock feed ingredients may be derived from any swine lines originating from Genus PRRSV-resistant pig events, provided that:
- (i) no inter-specific crosses are performed
- (ii) the intended uses are similar
- (iii) it is known, based on characterization, that these animals do not display any additional novel traits and feed ingredients derived from these animals are substantially equivalent to those that are currently permitted to be used as livestock feed in Canada, in terms of their livestock feed safety and nutrition
- (iv) the novel gene is expressed at a level similar to that of the authorized events
- (v) data used to establish the substantial equivalence of lines derived from Genus PRRSV-resistant pigs be made available to us upon request
Other regulatory requirements
Genus PRRSV-resistant pigs are subject to the same zoosanitary import requirements as unmodified swine. Genus PRRSV-resistant pigs are required to meet the requirements of other Canadian acts and regulations, including but not limited to, the Food and Drugs Act and the Canadian Environmental Protection Act.
The livestock feed assessment of novel feeds is a critical step in the potential commercialization of this genetically modified animal. Other requirements, such as the assessment of novel foods by Health Canada and the environmental safety assessment by ECCC and Health Canada, have been addressed separately from this review.
7. Contact us
For more information on this decision, please contact the CFIA's Animal Feed Program.