GENOME EDITION IN BRASIL: REGULATORY FRAMEWORK AND …€¦ · Global Regulatory Status Uruguay:...
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GENOME EDITION IN BRASIL: REGULATORY FRAMEWORK AND R&D ADVANCEMENT
Transcript of GENOME EDITION IN BRASIL: REGULATORY FRAMEWORK AND …€¦ · Global Regulatory Status Uruguay:...
GENOME EDITION IN BRASIL: REGULATORY
FRAMEWORK AND R&D ADVANCEMENT
Expo Milano 2015 – Feeding the Planet, Energy for Life
↑ 649,33%Prodution
↑ 186,53%Produtivity
↑ 161,52%Area
Brazil´s Grain (Rice, Beans, Corn, Soybean and Wheat) Production Area, Total Production and Productivity
World’s largest exporter of Beef, Coffee, Sugar, Orange juice, Ethanol, Chicken and Soybean in 2017.
Expo Milano 2015 – Feeding the Planet, Energy for Life
Evento: MON 87751/MON87701/MON 87708/MON 89788
Cry 1A.105 (Cry1Ab, Cry1F and Cry1Ac )+ Cry2Ab2 + Cry1Ac
Dicamba (dmo) e Glifosato (CP4-Epsps)
INTACTA 2 XTEND®
Evento: DAS-44406-6/DAS-81419-2
Cry1Ac + Cry1F
2,4-D (aad-12), Glifosato (2mepsps) e Glufosinato de Amônia (pat)
ENLISTTM
Drought Tolerant Soybean
Superexpressão Hahb-4 (homeodomain–leucine zipper
transcription factor) (Girassol)
Diminuição na senescência induzida por etileno
Commercial Use Approval - Maio2019
GM Soybean resistance to RustRESEARCH – Field Tests
GM Soybeans for Drought ToleranceMany DNA constructs in test
Crosses
New Genes
RESEARCH – Field Tests
Velocidade de Crescimento7 Anos em 5Evento H412
Eucalyptus
Primeira Árvore GM no Mundo
Liberado Comercialmente no Brasil09 de Abril , 2015.
Source: CTNBio, Abril 2015
GM Male Sterile Carterpillar (Lagarta do cartucho) Spodoptera frugiperda
Primeira LPMA para pesquisaautorizada em Maio 2019 pela CTNBio
RESEARCH – First Field Tests authorized in Brazil
• Insertion of genes to induce male sterility (Tetracycline)
•GM Males compete with Wild Males reducing total population.
• First results were presented to the scientific community recently in Juazeiro, Bahia, Brazil, where the experiment was conducted in open
areas with high Mosquito infestations.
Source: CTNBio, 2011; Oxitec do Brasil e USP, 2012.
“Paranóia” Mundial sobreOGM/Transgênicos na Agricultura
Custo Total Estimado: ~U$136 milhões
Source: McDougall, 2011; Prado et al, 2014
CIBio CIBio CIBio CIBio
CIBio CIBio CIBio CIBio CIBio
CIBio CIBio CIBio CIBio CIBio CIBio
MAPA
Anvisa
Ibama
National Biosafety CouncilNational Biosafety Technical Commission
Internal Biosafety Commissions
Registration and Inspection Bodies
Agriculture
Human Health
Environmental
Biosafety Law - 11.105/05 Structure
Risk Assessment
Maintenanceof biosafety
Registration andInspections agencies
National interest and socioeconomic factors (not an obligation)
“Brazilian Biosafety Law”Law nº 11.105, dated March 24th, 2005
Americas: >60% of world Grains
Countries with regulatory policy with exclusions
Countries with pending policies, regulations, or legal rulings
Countries with GMO only policy with no exclusions
Argentina, Brazil, Colombia, Paraguay, Chile: Case by case approaches; foreign DNA insertions generally regulated as GMO
Canada: Not regulated unless product identified as novel
Europe: European Court of Justice ruling genome editing techniques must be regulated as GMOs
Norway: Proposed; foreign DNA insertion regulated; case-by-case tiered approach –notification, expedited, standard review
Australia: Under review; possibly regulated whenever when templates involved; case-by-case review
Israel: Foreign DNA insertions regulated
China, Korea: Issue still being debated; no formal guidance
New Zealand: Initial “non-GMO” ruling for gene editing struck down by courts
Philippines, Japan: Under consideration; Foreign DNA insertions generally regulated as GMO
United States: For plants –USDA ‘Am I Regulated?’ letters, FDA & EPA under review
Global Regulatory Status
Uruguay: Proposal identical to other southAmerica countries
Mutações Sitio Dirigidas tipo:
SDN1
SDN2
SDN3
Saccharomyces cerevisiae Belgian-Brazilian
biotechnology startup
Yeast Germplasm Bank: 80 Strainstested for high alcohol and low
glycerol production
Development Procedures
Three S. cerevisiae strains chosen
and crossed by classical breeding
Excellomol
A Forth strain with very high alcoholproduction was identified. Mutation in4 genes are responsible for thishigh efficiency.
Excellomol 4.0 NextAll four mutations were introduced by CRISPR/Cas9 into the Excellomol strain
Amido de Milho tem75% Amilopectina and
25% Amilose
α-amyloseKnockOut
Bovino Sem Chifres: Importante naprodução leiteira
• Polled allele (from hornless breeds: Angus) to horned breeds (e.g Holstein) - Only few polled Holstein bulls available – frequency can be increased by genome editing
• Animal welfare (no need of calves dehorning)
• Animal management
Primero Animal Editado no Brasil
Angus
Holandês
Custo Total Estimado: ~U$136 milhoes
Source: McDougall, 2011; Prado et al, 2014
Esta redução noscustos esta
DEMOCRATIZANDO o uso da biotecnologiapermitindo que maisculturas, empresaspequenas e medias
também possamparticipar do Mercado.
Soybean: Seed Quality and Drought Tolerance
Knock Out and HR at promoter elements
Candidate genes for Knock Out and HR: Stay green1 (D1); Stay green2 (D2); Pheophorbidase (PH2) , DREB, AREB, DRIP, etc
CRISPR
Dr. Liliane Henning
Dr. Alexandre Nepomuceno
Sugarcane refinery
CRISPR-CANE PPO and Drought
• The sugar refinement requires addition of chemicals, demands sophisticated physical structure,
requires high cost and results in the removal of >90% of their vitamins and minerals;
• CRISPR-CANE PPO is an promising strategy due to the reduction of costs of refinement and
maintenance of the nutritional characteristics of sugar;
• It can be applied to several commercial cultivars;
• Global expansion of the Brazilian sugar market;
Catechol
PPOs/O2
It forms (melanin)
compounds
responsible for
the development
of dark coloration
(brown pigments)
Dr Hugo Molinari
Dr. Maria Fátima
Grossi-de-Sá
PROMOTER MODULATION OF DROUGHT-TOLERANCE
RELATED GENE WITH dCas9 CONFERS DROUGHT
TOLERANCE IN Arabidopsis thaliana
dCas9-Activator
dCas9-Represso
r
WT
Relative expression of Drought-tolerance-relatedgene
COMMON BEAN CRISPR TARGETS:
DROUGHT
TEGUMENT DARKENING (POLIFENOL OXIDASES?)
ANTINUTRICIONAL FACTORS (RAFINOSE,
ESTAQUIOSE, VERBASCOSE, ETC)
PROTEIN CONTENT/QUALITY
Dr. Josias Correa de Faria
Dr. Rosana Vianello
Development of a tool kit for genome edition with new enzymes (Nucleases) from Brazilian biodiversity
ENZYMES ISOLATED FROM BRAZILIAN BIODIVERSITY( AMAZON FOREST, AMAZON RIVER, BACTERIAS FROM CERRADO)
AGRICULTURAPECUÁRIAMICRORGANIMOS
Increase the thermotolerance
• By the introgression of genes or mutations associated to heat tolerance• Ex. Slick hair locus derived from cattle breeds like Senepol and Criollo
(Caribean Bos taurus) associated to an increased thermotolerance• short hair length
• Holstein cows with short hair - more tolerant to heat stress
Parasites
• Animals more resistant to parasites• Zebu cattle (Bos indicus) – more resistant to ticks• Search for target genes and mutations• Genomic selection and/or editing
• Control of insect population (ticks and flies)
• High infestation causes low productivity• Uses of insecticides – milk withholding period
• diseases transmission (babesiosis and anaplasmosis)
• CRISPR/Cas9 and gene drive
Image: http://www.portaldbo.com.br/mundo-do-leite/edicao-atual/carrapato-do-boi-o-equilibrio-e-a-solucao/14151
Image fly: http://www.revistaveterinaria.com.br/2012/03/29/bicheiras-veja-como-evitar/
Increase the rumen digestibility• Low digestibility of tropical forages – due to high content of
hemi-cellulose and/or lignin
• Can not be digested by rumen microbiome - lack of enzymes
• Modification of rumen microbiome to express fibrolytics or ligninolytic enzymes:
• Xilanases (hemi-cellulose), laccases (lignin), etc
• Contributes to increase feed efficiency
Reduce methane emission
• Emission of non-CO2 greenhouses gases (e.g. methane)• 21% of non-CO2 emission is projected to be from livestock in 2030
