specialty crop regulatory assistance case studies 3
TRANSCRIPT
Specialty Crop Regulatory Assistance
Case Studies 3
Hypoallergenic Peanuts
Hortense Dodo, President
Oct 3-5, 2018
SCRA Workshop III Riverdale MD
1www.ingateygen.com
The Peanut as a CropArachis hypogaea
➢ Peanut is a legume, Not a nut
➢ Arachis hypogaea is an allotetraploid (2n=4x=40)
derived from distinct A and B genomes (A. duranensis and A. ipanesis)
➢ Said to have originated in Latin America
➢ No known species in the US, known to naturally outcross with A. Hypogaea.
➢ Self pollinated with natural outcrossing rates in the field reported from
0 to 2.8% (Coffelt, 1989).
➢ A week after fertilization, pegs form and grow toward the ground.
➢ Seeds develop in pods at the ends of the pegs underground .
➢ No reference to A. hypogaea or any of its relatives as a weedy species has been found.
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Peanut varieties grown in the U.S.
Taxonomy of Peanut
Source: USDA National Resource Conservation Service
Peanut Production 2017
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5Source :https://www.dcallergy.com/services/food-allergy
The Food Allergen Labeling and Consumer Protection Act (FALCPA)A law that requires all food labels in the US to list ingredients that may cause allergic reactions, and
was effective as of January 1, 2006. While many ingredients can trigger a food allergy,this legislation only specifies the 8 major food allergens.
Food Allergen Labeling & Consumer Protection ActFDA Big 8 – Common Food Allergens
Social Impact of Peanut Allergy
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➢ Of all allergic foods, Peanuts are responsible for the most severe and fatal food allergies and 63-67% deaths due to food anaphylaxis.
➢ Data from CDC shows Prevalence is growing. ➢ There is an increased in accidental ingestion of peanuts.➢ There is an increased in FDA food alerts and food recalls for food
companies.➢ Food Recalls are the biggest threat to profitability ~ $55.5 Billion/year
in direct + indirect costs not to count damage to brand reputation.
➢Yet to date, there is no cure➢Management is limited to strict dietary avoidance, nutritional counseling,
and emergency treatment with Epi Pen shots.
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Ara h 3
Ara h 2
Ara h 1
• 50 to 95 % prevalence in the peanut sensitive population • Are the main elicitors of allergic reactions in the USA• HIGH RISK of systemic clinical and severe symptoms
→ Anaphylaxis → Coma → Death
Ara h 8 LOW RISK of systemic reaction → Risk of mild, local symptoms, → Cross- reactive with pollens
Ara h 9 LOW RISK of systemic reaction → Cross-reactive with fruits pits
Peanut proteins that frequently provoke
allergies and their level of allergenicity
IGG’s technology to eliminate most potent allergenic proteins
Economic Impact
➢ U.S. Food Allergies Cost $25 Billion (hospitalization
and health care cost)
➢ US economic burden / food-allergic child/year:
– Direct medical costs: $4.3 B ($724 / child/y)
– Out-of-pocket costs: $5.5 B ($931 / child/y)
– Lost work productivity: $0.8 B ($130 / child/y)
– Lost work opportunities: $14.2 B ($2,399/ child/y)
– Per Child Total: $4,184.
➢ Government purchase for school lunch programs is reduced over 14%
➢ Banned from many public schools
➢ Restricted use in the airline industry
➢ Increasing number of lawsuits
➢ Large number of food allergy alerts and food recalls
➢ National annual cost of recalls- Estimated ~ $55.5 Billion
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Recalls Summary
2015 2016 2017Total
Number of
Recalls
Quantity of
products
Recalled
(In lb)
Total
Number of
Recalls
Quantity of
products
Recalled
(In lb)
Total
Number of
Recalls
Quantity of
products
Recalled
(In lb)
150 21,104,848 122 58,140,787 131 20,880,574
ClassI 99 (66%) 16,623,878 91 (75%) 56,464,938 100 (76%) 18,761,576
II 39 (26%) 3,176,212 26 (21%) 1,063,553 22 (16%) 1,084,788
III 12 (8%) 1,304,758 5 (4%) 612,292 9 (7%) 1,034,210
Reasons
For
Recalls
STEC 8 215,593 14 291,900 8 144,997
Listeria 6 82,537 11 47,398,142 15 546,278
Salmonella 3 4,828,874 2 19,287 1 1,076
Undeclared Allergens 58 10,268,457 34 843,536 53 8,761,495
Extraneous Material 11 1,104,790 21 6,372,416 24 9,043,982
Processing defect 4 5,259 5 1,999,078 5 387,357
Undeclared substance 5 1,176,731 7 662,595 6 1,020,654
Other 55 3,42,597 28 553,837 17 971,347
Summary of US Recall incidence
2015-2017
National annual cost of recalls - Estimated ~ $55.5 Billion
No naturally-occurring
Allergen-Free peanut variety
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Isolation and characterization or the genomic
sequences of major peanut allergens (Ara hA1-2-3)
Molecular Characterization of
Genomic Clone of Major Allergen Ara h2
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Fig. 2Nucleotide and deduced amino acid sequences of the gene encoding the peanut allergen Ara h 2. From top to bottom, a putative TATA box, the ATG initiation codon, the first stop codon (TGA), and the putative polyadenylation signal are in bold. The 21 putative amino acid signal peptide is underlined. Six additional stop codons are underlined. The deduced amino acid sequence is below the nucleotide sequence.
Source: Journal of Allergy and Clinical Immunology, 2001: Vol 107-4-713-17
Proof of concept - Ara h2Production of Transgenic Peanut via Organogenesis
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Elimination of Ara h2, most potent allergen
Binary Vector pART 27, Glen et al; Plant Mol Biol. 1992 Dec;20(6):1203-7.
Disarmed Agrobacterium EHA105 Hood EE, Trans Res, 1993, 2, 208.
Peanut Propagation
TC chamber: Controlled Temp, Light, Humidity /
Biosafety Level 1 Confined Greenhouse: No significant variation in growth transgenics vs WT
Notification for the Introduction
of a Regulated Article
• Yearly application for notification
• For field releases
• Inspection by USDA-APHIS → compliance
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Field Trials
No significant difference in growth, seed formation and agronomic traits of Transgenic peanut plants vs WTA post harvest inspection by USDA-APHIS
Peanut Pollination and Weediness
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➢ Self pollinated with natural outcrossing rates in the field reported from 0 to
2.8% (Coffelt, 1989).
➢No species in the US known to naturally outcross with A. hypogaea.
➢No reference to A. hypogaea or any of its relatives as a weedy species.
PCR, Southern, Gene Copy,
ELISA and Western Blots
Proteins Ara h1, Ara h2 and Ara h3 eliminated in transgenic peanut seeds vs WT
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Sandwich ELISAContent of Allergen Ara h1 (ug/ml) is significantly lower in new peanut lines vs WT
Sandwich ELISA
References
• The Multiplier Effect Strikes Again, Stericycle Expert Solutions.
• A Look Back at 2015 Food Recalls Undeclared Allergens and Automation: The Crossroad of Food
Safety and the Reduction of Recalls Ready-to-Eat Foods: Preserving the Trust of the Consumer.
• Listeria, Salmonella and Escherichia coli: Oh My! Avoiding Allergens: It's the Right Thing to Do
Protecting Your Customers from Foodborne Illness.
• Food Recalls from the Perspective of the Retailer- T Maberry, Food Safety Magazine's digital editor.
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