Scientific advancement of novel protein allergenicity evaluation: an overview of work from the HESI Protein Allergenicity Technical Committee (2000-2008).
The safety assessment of genetically modified crops includes the evaluation for potential allergenicity. The current 'state-of-the-science' utilizes a weight of evidence approach, as outlined by the Codex Alimentarius commission (Alinorm 03/34 A), recognizing no single endpoint is predictive of the allergenic potential of a novel protein. This approach evaluates: whether the gene source is allergenic, sequence similarity to known allergens, and protein resistance to pepsin in vitro. If concerns are identified, serological studies may be necessary to determine if a protein has IgE binding similar to known allergens. Since there was a lack of standardized/validated methods to conduct the allergenicity assessment, a committee was assembled under the International Life Sciences Institute Health and Environmental Sciences Institute to address this issue. Over the last eight years, the Protein Allergenicity Technical Committee has convened workshops and symposia with allergy experts and government authorities to refine methods that underpin the assessment for potential protein allergenicity. This publication outlines this ongoing effort, summarizing workshops and formal meetings, referencing publications, and highlighting outreach activities. The purpose is to (1) outline 'the state-of-the-science' in predicting protein allergenicity in the context of current international recommendations for novel protein safety assessment, and (2) identify approaches that can be improved and future research needs.
International Life Sciences Institute, Health and Environmental Sciences Institute, 1156 Fifteenth Street, NW, Second Floor, Washington, DC 20005, United States.
Karluss
K
Thomas
Sue
S
MacIntosh
Gary
G
Bannon
Corinne
C
Herouet-Guicheney
Michael
M
Holsapple
Gregory
G
Ladics
Scott
S
McClain
Stefan
S
Vieths
Michael
M
Woolhiser
Laura
L
Privalle
D000818:Animals; D019295:Computational Biology; D004044:Dietary Proteins / Q000009:adverse effects* / Q000032:analysis / Q000276:immunology*; D004195:Disease Models, Animal; D005512:Food Hypersensitivity / Q000276:immunology*; D005525:Food-Processing Industry; D006801:Humans; D012449:Safety
D004044:Dietary Proteins