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Protein Allergenicity Technical Committee

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MISSION

The mission of the Protein Allergenicity Technical Committee is to advance the science related to the development of reliable and accurate methodologies to characterize the allergenic potential of novel proteins.

 

 

BACKGROUND

 

An important component of the safety assessment of biotechnology products is to make a determination of the allergenic potential of newly expressed proteins.

The safety of genetically-modified organisms (GMOs) for human consumption continues to generate substantial interest in the international scientific community.  Scientists in government, academia, and industry have been working to determine the most effective manner to conduct safety evaluations for GMOs.  A key part of these safety evaluations is an allergenicity assessment that is done to characterize the extent to which the GMO might cause allergic reactions in humans.

 

 

COMMITTEE ACTIVITIES

The HESI Protein Allergenicity Technical Committee has been engaged in a suite of activities to advance the science related to predicting human allergic potential from exposure to novel proteins and GMOs.  

 

 

Ø       Regulators Meeting, April 15, 2008

In collaboration with the ILSI Research Foundation and the ILSI International Food Biotechnology Committee (IFBiC), a NAFTA regulators meeting was held on April 15th, 2008 in Washington, DC to provide a forum for individuals from various organizations within NAFTA counteis to learn about ILSI's biotechnology activities.  It also provided an opportunity for ILSI and all attendees to better understand the regulatory, research, and development priorities and challenges for biotechnology with the organizations across the region.  For more information about this workshop, click here.

 

Ø       New Methods Workshop, October 23 - 25, 2007

The committee hosted an expert workshop October 23 - 25, 2007, in Nice, France to review and discuss new methods and techniques that could facilitate the development of improvements to the current weight-of-evidence (WoE) approach for evaluating the allergenicity of novel proteins.  The workshop explored emerging methods that could have utility for improving risk and safety evaluations for novel proteins including the use of proteomic techniques for evaluating plant expression characteristics, and the use of in vitro mast cell and basophil activation assays.  The workshop proceedings will be submitted for publication in Food and Chemical Toxicology.  For more information about this workshop, click here.

 

Ø       Sera Bank Workshop April 25 - 27, 2006

The committee hosted a workshop April 25-27, 2006, in Seoul, Korea to evaluate the scientific considerations associated with the development of sera banks to support novel protein allergenicity evaluations.  The specific objectives of the workshop included identifying reasons for performing sera studies for allergenicity evaluations, defining acceptance criteria for the inclusion of sera in a bank, describing the appropriate methods for performing sera studies, and defining criteria for the assessment of sera studies.  The workshop was attended by international experts from government, academia, and industry.  The workshop proceedings were published in Toxicological Sciences.  For more information about this workshop, click here.

 

Ø       Food Processing Workshop, June 19 – 21, 2006

In collaboration with ILSI Europe, the ILSI Research Foundation, and the ILSI International Food Biotechnology Committee (IFBiC), the committee hosted a workshop in Estoril, Portugal to assess the effects of food processing on allergenicity.  The purpose of the workshop was to characterize the extent to which various food processing variables impact human allergenicity.  The workshop was attended by over 30 international experts from government, academia, and industry.  The workshop proceedings were published in Food and Chemical Toxicology.  For more information about this workshop, click here. 

Ø      Argentina/Brazil Outreach, November 2006

Collaboratively with ILSI Argentina and ILSI Brazil, the committee organized outreach sessions in Buenos Aires, Argentina on November 17, 2006, and Sao Paulo, Brazil on November 20, 2006.  These sessions were intended to provide an opportunity for the PATC to provide an update on the committee’s efforts to improve the scientific basis for conducting allergenicity evaluations for novel proteins to local sceintists. These sessions also allowed an opportunity for the committee to seek some perspective from local scientists regarding their priorities for conducing risk and safety evaluations for novel proteins, and attempt to identify collaborative activities where the PATC could continue to engage scientists in these countries on projects where there are mutual interests. 

 

Ø       Bioinformatics Workshop, February 22 – 24, 2005

The committee hosted a workshop February 22 - 24 in Mallorca, Spain to evaluate the current methodologies used for identifying similarities to known allergens and toxins.   This workshop was a part of the committee’s broader activities that are focused on advancing the scientific understanding of the relevant parameters for characterizing the allergenic potential of novel proteins and biotechnology products.  The workshop summary and discussion was published in Molecular Nutrition and Food Research.  For more information about this workshop, click here.

 

 

LEADERSHIP AND INFORMATION

Chair............................................. Dr. Laura Privalle

 

Vice Chair........................................ Dr. Greg Ladics

 

HESI Staff................................. Dr. Michelle Embry

 

 

For more information, please contact: Michelle Embry at (202) 659-3306 or membry@hesiglobal.org.

 

For an English version of the Protein Allergenicity Technical Committee fact sheet, click here.

 

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COMMITTEE PARTICIPANTS

BASF Corporation

Bayer CropScience

The Dow Chemical Company

E.I. du Pont de Nemours and Company

Monsanto Company

Syngenta Corporation

Paul Ehrlich Institut (Germany)

U.S. Environmental Protection Agency

U.S. Food and Drug Administration

Japanese Ministry of Health Labor and Welfare

 

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